Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:dc29616930703388b93de1d353e4decd' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>The purpose of this research study is to understand the effects of testosterone (T) and estrogen on stem cells in the blood. The knowledge will be used to help understand the effects of T and estrogen on cardiovascular (heart and blood vessel) disease. The knowledge will also be used to help in the development of a safe male hormonal contraceptive.</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:dc29616930703388b93de1d353e4decd' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Hormonal Regulation of Circulating Endothelial Progenitor Cells and HDL-C in Men</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:4e37f9bad2b8b2b80076db1a82c0c582' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>We will be administering three drugs: Testim (testosterone gel) anastrozole and acyline. We want to see their effects on stem cells and hormone levels in the blood. Acyline suppress LH (luteinizing hormone) and FSH (follicle-stimulating hormone), which are hormones made by the pituitary gland, thus blocking the signal from the brain that causes the testes to make testosterone. Therefore acyline blocks testosterone production. Some men may experience side effects such as hot flashes or irritability from the low levels of T caused by acyline. We are studying whether adding T to acyline will reduce or eliminate these side effects. Since heart disease is a common problem in men we want to know about the effects of male hormonal contraception on the cardiovascular system. One way to evaluate these risks is to measure the number of progenitor cells and the types of cholesterol in the blood. Progenitor cells are cells that travel in the blood and go to areas of blood vessel injury to help repair the damage amd may help prevent heart attacks and stokes. Some studies suggest that T administration may increase the number of these cells in the blood but other studies have shown that estrogen may be responsible for this effect. In addition, T and estrogen may affect the amount and type of HDL cholesterol in the blood. This is the &quot;good&quot; cholesterol that is thought to protect people from heart attacks and strokes. Therefore, more studies to test the effects of T and estrogen on progenitor cells in the blood and to understand HDL cholesterol in men receiving testosterone are needed. Acyline is an experimental drug. The FDA allows it use only in research with a small number of volunteers. So far, over on 125 men have received acyline. Anastrozole is a drug that blocks the production of estrogen from testosterone. Anastrozole had been given to men safely in the past. Anastrozole in not approved for use in men and is also an experimental drug. Testosterone gel will also be used in this study. It is FDA approved for ise in men with low testosterone levels.</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:8bb0781fd729f2b940dc3c52cfd81815' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ul>\n<li>Males age 18-55 years</li>\n<li>Normal serum total testosterone (300 ng/dl-1000 ng/dl)</li>\n<li>Normal LH and FSH levels</li>\n<li>Taking no regular medications</li>\n<li>Normal baseline serum hematology, chemistry and liver function tests</li>\n<li>Agrees not to donate blood during the study</li>\n<li>Agrees to use a form of contraception during the study</li>\n<li>Subject must be able to comply with all study procedures</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Clinically significant screening assessments or other relevant disease, allergy or surgery, as revealed by history, physical examination and/or laboratory assessments, which may limit participation or prevent completion of the study</li>\n<li>History of prostate cancer, breast cancer, or benign prostatic hypertrophy</li>\n<li>Prostate-specific antigen (PSA) &gt; 3.0</li>\n<li>History of regular, chronic testosterone or anabolic steroid use in the past year</li>\n<li>Chronic medical illness, prostate disease, or cardiovascular disease</li>\n<li>History of a bleeding disorder or need for anticoagulation</li>\n<li>Skin condition that might interfere with or be exacerbated by T gel use</li>\n<li>Sitting systolic blood pressure &gt; 180mm Hg or &lt;90 mm Hg or sitting diastolic blood pressure &gt;110 mm Hg or &lt; 60 mm Hg.</li>\n<li>History of clinically significant, untreated sleep apnea</li>\n<li>Participation in another drug-related research study within the past 2 months</li>\n<li>Participating in a regular physical relationship with a pregnant woman</li>\n<li>History of hypersensitivity to any of the study medications (T gel, anastrozole, acyline)</li>\n<li>History of medical or surgical therapy for benign prostatic hypertrophy</li>\n<li>Hematocrit &gt; 55%</li>\n<li>History of drug or alcohol abuse within last 6 months</li>\n<li>Abnormal digital rectal exam at screening</li>\n</ul>\n</p>', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:794e5f25aebd0f96f9184b6bfc8b4111' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Many patients who have sustained strokes are unable to effectively use their hemiparetic upper extremity. Limited mobility in the performance of daily activities, such as eating or dressing, adversely affects their quality of life and compromises independence. Rehabilitation techniques engaging the hemiparetic limb in repetitive task practice (RTP) may improve upper extremity function and quality of life in patients with stroke, but costs limit the number of patients that can utilize this type of therapy. Advances in microprocessor design and function make the use of an assistive device as an adjunct to RTP plausible. An innovative assistive repetitive motion (ARM) device using an &quot;air muscle&quot; has been developed specifically for the rehabilitation of the hemiparetic upper extremity. The primary aim of the proposed study is to collect pilot data to estimate the clinical effectiveness of using the ARM device in conjunction with RTP to improve upper extremity motor function and the quality of life of patients with stroke. Twenty sub-acute (3 to 9 mos. post-stoke) patients will be randomized to a RTP only or ARM + RTP group. The RTP group will receive 15 days (4 hours per day) of intensive one-on-one RTP therapy. The ARM + RTP group will use the ARM device for 2 hours per day and receive 2 hours of intensive RTP per day for 15 days. Clinical motor function and quality of life measures will be taken before and after the interventions and two months later. We hypothesize that the ARM + RTP group will exhibit greater improvements in motor function and quality of life measures than the RTP only group.</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:2e6d3af0d8e33ba6b7eb830750632156' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Air Muscle and Task Practice in Upper Limb Stroke Rehab</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:ba75bb003724641be41d2ac873d1ff6c' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:3276a8adb9e5b417b0ac2967184eaaf0' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Specific Aim 1: Estimate the effectiveness of using an assistive repetitive motion device (ARM) in conjunction with repetitive task practice (RTP) on motor recovery of patients with sub-acute stroke. This aim will be examined by comparing pre-intervention motor performance levels with the immediate post-intervention and two months post-intervention. The primary outcome variables will be scores on the Fugl-Meyer Motor Assessment Test (FMA) and Wolf Motor Function Test (WMFT). We hypothesize patients in the RTP + ARM group will exhibit greater gains in upper extremity motor recovery/performance than the RTP and ARM only groups. Specific Aim 2: Estimate the effectiveness of using the ARM device in conjunction with RTP on health related quality of life of patients with sub-acute stoke. This aim will be examined through the administration of clinical quality of life questionnaires. The primary outcome variable to assess health related quality of life will be change scores on the Stroke Impact Scale (SIS), controlling for depressed mood as measured by the Center for Epidemiologic Studies Depression (CES-D) scale, from the pre-, immediate post and two-month post intervention testing sessions. We hypothesize patients in the RTP + ARM group will exhibit greater improvements on quality of life measures at the two-month follow-up session than the RTP and ARM only groups. Study Design, Methods and Procedures: Patients will be randomized to one of the following three interventional groups: repetitive task practice, assistive repetitive motion and repetitive task practice plus assistive repetitive motion. Details regarding the activities each group will perform are below.\n<ol>\n<li>Repetitive task practice (RTP) procedure: patients in the RTP group will work closely with rehabilitation professional (supervisor) for four hours per day for three weeks. We are currently accepting applications for this position. At minimum, this individual will be a licensed Physical or Occupational Therapist with clinical experience and a desire to participate and follow the outlined research protocol. Patients will report to the Mellon Center at the Cleveland Clinic Foundation (CCF) around 8:00 AM each day and leave around 12:00 PM. During their stay at the CCF they will be asked to engage in a series of activities that are planned for them to use their weaker or more impaired hand and arm. We will be making some additional measures about the speed at which they can do functional activities (such as reaching and folding a towel) during the testing days immediately before and after the training period and two months after completion of the training (e.g. Wolf Motor Function Test (WMFT) and Fugl-Meyer Motor Assessment (FMA)). Quality of life will be assessed with the Stroke Impact Scale (SIS) controlling for depression using the Center for Epidemiologic Studies Depression (CES-D) scale. These clinical tests require approximately 1.5 hours to administer. Participants will also be encouraged to use their weaker hand and arm at home and during the weekends. </li>\n<li>Assistive repetitive motion (ARM) procedure: Patients will report to the Mellon Center at the Cleveland Clinic Foundation (CCF) around 8:00 AM each day and leave around 12:00 PM. During their stay at the CCF they will be asked to wear an assistive device on their more impaired or affected upper extremity. This device will be placed snugly on their arm and wrist. The device has a small &quot;air muscle&quot; that when activated will slowly lift their fingers and wrist from your resting wrist position. This device is classified as a non-significant risk device by the FDA (see attached letter dated 1-15-05). The patient should not experience any pain or discomfort during this stretching activity. If they do experience any pain or discomfort they can activate a stop switch located on the control box with their unimpaired hand. The SIS, CES-D WMFT and FMA will be administered immediately before and after the training period and two months after completion of the training.</li>\n<li>RTP + ARM Procedure: Patients will report to the Mellon Center at the Cleveland Clinic Foundation (CCF) around 8:00 AM each day and leave around 12:00 PM. During their stay at the CCF they will be asked to wear an assistive device on their more impaired or affected upper extremity for two hours. This device will be placed snugly on their arm and wrist. The device has a small &quot;air muscle&quot; that when activated will slowly lift the fingers and wrist from a resting wrist position. They should not experience any pain or discomfort during this stretching activity. If they experience any pain or discomfort they can activate a stop switch located on the control box with the unimpaired hand. After completion of the two hour ARM intervention they will participate in two hours of RTP therapy. During this time they will engage in a series of activities that are planned for them to use the weaker or more impaired hand and arm. The SIS, CES-D WMFT and FMA will be administered immediately before and after the training period and two months after completion of the training.</li>\n</ol>\n</p><p> The results from this project will provide valuable data as a pre-requisite for submission of a multi-year R01 randomized clinical trial to determine the clinical efficacy of using an assistive device, such as the ARM, as an adjunct to RTP. This project has the potential to increase the availability of effective rehabilitation techniques to patients with stroke. Inclusion criteria Patients will not be excluded because of somatosensory deficits or the nature of previous physical interventions. We will not randomize patients on the basis of side of stroke or hand dominance but will undertake secondary data analyses examining these variables. In past applications of one form of RTP, CI therapy, to chronic stroke patients in the laboratories of Taub and Miltner, there were no significant differences in treatment effects for patients with right and left-sided strokes. In previous evaluations of CI therapy, Taub did not find any difference in outcomes among the small percentage of patients with pre-morbid left dominance. Therefore, there is no reason to exclude these patients from participation. We believe that the motivation to improve use of an affected pre-stroke non-dominant upper extremity is sufficiently strong to support profound improvement from treating that limb as well as from treating the dominant limb. Distributions of dominance and hand preference have been acquired from patients meeting eligibility criteria in 1998 at several sites for determining participation of sites for the EXCITE trial and side of cerebral pathology showed remarkably equal left-right distribution. Exclusion criteria\n<ol>\n<li>a score of less than 24 on the Folstein Mini-Mental State Examination or a score of 36 or below on the Token Test of the Multilingual Aphasia Examination</li>\n<li>a first stroke less than 3 months or more than 9 months prior to the initiation of therapy</li>\n<li>less than 18 years old</li>\n<li>clinical judgment of excessive frailty or lack of stamina (e.g., cannot attend to instructions, stay awake, engage in functional activities, etc.)</li>\n<li>serious uncontrolled medical conditions</li>\n<li>excessive pain in any joint of the more affected extremity that could limit ability to cooperate with the intervention, as judged by the examining clinician</li>\n<li>passive range of motion less than 45 degrees for: abduction, flexion or external rotation at shoulder, or pronation of forearm; or greater than 30 degrees flexion contracture at any finger joint (patients who pass the motor criteria specified above do not tend to have the type of pain or limitation of movement that would exclude them from treatment)</li>\n<li>unable to stand independently for 2 min., transfer independently to and from the toilet or perform sit-to-stand</li>\n<li>current participation in other pharmacological or physical intervention studies, or have received injections of anti-spasticity drugs into upper extremity musculature within the past 3 months, or wish to have drugs injected in the foreseeable future</li>\n<li>receiving any anti-spasticity drugs orally at the time of expected participation</li>\n<li>received phenol injections less than 12 months prior to receiving therapy</li>\n<li>contemplating a move from proximity to the treatment site in less than 1 year from the randomization date. Prospective patients who qualify but who have profound postural instability will undergo the intervention while walking with contact guarding or, when feasible, using their leg(s) and more involved arm to propel a wheelchair.</li>\n</ol>\n</p>', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:3276a8adb9e5b417b0ac2967184eaaf0' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>PCOS is the major cause of infertility in the United States. Many women with PCOS demonstrate insulin resistance and a compensatory hyperinsulinemia.This is due to both an intrinsic form of insulin resistance unique to PCOS and, in many cases, acquired insulin resistance due to obesity. The importance of this observation lies in the fact that hyperinsulinemia appears to play an important pathogenetic role in the hyperandrogenism and anovulation of both obese and lean women with PCOS.</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:b00d575ce595fba3868800470e7ec329' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Determination if Pharmacologic Blockade of Androgen Action Decreases Renal Clearance of DCI, Increases the Circulating Concentration of DCI, and Enhances Insulin-Stimulated Release of the DCI-IPG Mediator in Obese Women With PCOS</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:9e0c16a283c807bbb2b0509fcad704f0' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:1c89d8d81abe8e4ad30ef5f1814cb7c2' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Hyperinsulinemia stimulates ovarian production of androgens, especially testosterone, in PCOS. Therefore, it is theoretically possible that testosterone increases uClDCI in PCOS, and that this serves as the explanation for the correlation between uClDCI and insulin sensitivity. While we regard this possibility as unlikely, it is important that it be tested. To accomplish this, we will assess obese (BMI &gt;30 kg/m2) women with and without PCOS at baseline, and again after 4 weeks of androgen action blockade with the drug flutamide. Flutamide is an antiandrogen that works by blocking the binding of androgens to the androgen receptor. We will determine if this pharmacologic blockade i) decreases the renal clearance of DCI, ii) increases the circulating concentration of DCi, and iii) enhances the insulin-stimulated release of the DCI-IPG mediator during an OGTT.</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:1c89d8d81abe8e4ad30ef5f1814cb7c2' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria: (1) Obese (BMI&#8805;30 kg/m2) women with PCOS between 18-40 years of age: i) oligomenorrhea (8 menstrual periods annually), ii) biochemical hyperandrogenemia (elevated total or free testosterone), iii) normal thyroid function tests and serum prolactin, and iv) exclusion of 21&#945;-hydroxylase deficiency by a fasting 17&#945;-hydroxyprogesterone &lt;200 ng/dl.48, (2) acceptable health on the basis of interview, medical history, physical examination, and laboratory tests (CBC, SMA20, urinalysis, serum BhCG). (3) Signed, witnessed informed consent. (4) Ability to comply with study requirements. Exclusion Criteria: (1) Diabetes mellitus by fasting glucose or OGTT, or clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, neoplastic and malignant disease (other than non-melanoma skin cancer). (2) Current use of oral contraceptives. (3) Documented or suspected recent (within one year) history of drug abuse or alcoholism. (4) Ingestion of any investigational drug within two months prior to study onset. -</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:d883aa8d32056d81dcb8740242bafdb8' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>The purpose of this study is to test the effectiveness of a woman-focused HIV prevention intervention combined with voluntary counseling and testing (VCT), compared to VCT only, and VCT combined with an attention-control nutrition intervention.</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:d08912475395faa74e6179be2430a7a7' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>&nbsp;</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:cc7819055cde3194bb3b136bad5cf58d' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:decacedac439a76b6cdcdf686eb60e90' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Surveillance data indicate that HIV risk and substance use is a serious problem among South African women. This study, funded by the National Institute on Child Health and Human Development (NICHD), builds on findings from a recently completed pilot study among women in less affluent townships and communities in the Western Cape (Wechsberg et al., 2008). The pilot study tested the effectiveness of an evidence-based woman-focused intervention in reducing drug use, sexual risk, and victimization by addressing the intersection of these factors among 100 poor, substance-using women of colour. The primary aim of this study is to test the effectiveness, through a randomized controlled trial (RCT), of VCT plus a woman-focused intervention relative to VCT only to increase knowledge and skills to reduce substance abuse, sexual risk, and victimization, and to an equal-attention (nutrition) control group at 3-, 6-, 9-, and 12-month follow-ups. A secondary aim is to examine the moderating effect of victimization (i.e., sexual and physical) and the mediating effects of HIV risk knowledge, condom use skills, sexual negotiation assertiveness, and relationship power on the effectiveness of the woman-focused groups to decrease risk related to drug use, sexual risk, and sex-related-victimization relative to the rapid testing group and to the equal-attention control group.</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:decacedac439a76b6cdcdf686eb60e90' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ul>\n<li>To be eligible for the study, participants must be: (a) female; (b) report use of at least two drugs&#8212;alcohol, marijuana, methamphetamine (tik), Mandrax (methaqualone), cocaine (crack and/or powder), heroin (Thai White), glue, MDMA (ecstasy), or LSD&#8212;at least once a week in the past 90 days; (c) be sexually active within the past 30 days; (d) be aged 18 to 33 years; (e) live in the communities around the airport; and (f) provide verbal consent to be screened for eligibility and written consent to participate in the study.</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>If participants do not meet all of the inclusion criteria, they will be excluded from the study.</li>\n</ul>\n</p>', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:210b97f9773fbc90e2392a0bbf5e46df' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>The Jump-In study will prospectively assess the effects of impact exercise on skeletal development in young girls, including bone mass, bone mineral density, and bone geometry. We hypothesize that girls who regularly participate in impact loading exercise will accrue greater skeletal mass, increase bone density and undergo structural adaptations that in combination will improve bone strength compared to girls who do not participate in impact exercise.</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:7497cd6c90908763c1bf8b8a4c09dd5d' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Exercise and Bone Development in Young Girls</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:1b8dd8a85e9059be6ccd1a16471e1566' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:31e6a377d0f001984b933c9393e0b37f' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Jump-In is a school-based, block-randomized, trial of the effects of impact-loading exercise on skeletal development in prepubescent and early pubescent girls. Fourth (n=~200) and sixth (n=~200) grade girls in 14 Tucson (Arizona) schools with no contraindication to physical exercise will be enrolled. Girls in intervention schools will participate in impact activities 3 times per week at school, progressively increasing the number (up to 40) of jumps and their height (from 6 inches to 18 inches per repetition) over the initial 2 months. Thereafter, new activities will be introduced approximately every 2-3 months to maintain interest and motivation, and continually stress the skeleton in novel ways, over 2 years of intervention. Physical and behavioral assessments will be done in both intervention and control groups at baseline, end of the initial school year, and yearly thereafter for 5 years. Assessments include height and weight, selected skeletal lengths, fat, lean soft tissue, bone mineral content and areal density from dual energy x-ray absorptiometry (DXA), and bone geometry (e.g., cortical thickness, periosteal circumference and cortical and trabecular density) and muscle area from peripheral quantitative computed tomography (pQCT). Also, maturation will be assessed via the Tanner Stage (self-assessment against standardized drawings of stages of physical development), diet from the Harvard Youth Food Frequency Questionnaire, and physical activity using pedometers and standardized questionnaires. We hypothesize that girls in intervention schools will demonstrate enhanced skeletal development, including greater mineral mass and density, and enhanced bone geometry, leading to greater bone strength compared to girls in control schools. We further hypothesize that younger (Tanner State 1) girls will experience greater adaptations than older girls (Tanner 2 and 3), and that positive adaptations will be maintained throughout the 3-year follow-up period.</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:31e6a377d0f001984b933c9393e0b37f' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:b88bd80b1b63c9d1763aa6fac0fc4b74' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria: female; entering 4th or 6th grade at enrollment; and willing and able to undergo all of the testing requirements; no physical activity limitations; able to read and write English. Exclusion Criteria: Girls with severe learning disabilities (identified by schools), who are unable to complete questionnaires or otherwise comply with assessment protocols will be excluded. Any subjects (or potential subjects) suffering from medical conditions and/or disabilities that would limit their participation in exercise will be excluded from the study, following the American Academy of Pediatrics (AAP) guidelines. Further, any volunteers who are taking medications that would limit exercise and/or alter bone mineral accrual will also be excluded from the study. Girls with a positive pregnancy screening test at the time of the lab visit before DXA scanning will be excluded.</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:b88bd80b1b63c9d1763aa6fac0fc4b74' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:79bb3a7c75c2777eaed2707f003ff1c1' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>This study focuses on the validation of the Adaptation Index instrument as a measurement of adaptive behaviors used to reduce symptoms of FI and to describe the use of adaptive behaviors among women with FI.</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:79bb3a7c75c2777eaed2707f003ff1c1' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:c3226a772c3e668fa37e981e6ab89213' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Fecal Incontinence Severity Index (FISI) [&nbsp;Time&nbsp;Frame:&nbsp;baseline, 2 wk, 3 mo, 12 mo&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:c3226a772c3e668fa37e981e6ab89213' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:cfeeccb8662df2b846c59104112b71f4' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Medical Outcome Study Short-Form (SF-12) [&nbsp;Time&nbsp;Frame:&nbsp;baseline, 3 mo, 12 mo&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:cfeeccb8662df2b846c59104112b71f4' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:022ceac05f15daf64eb0ae057020130e' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ) [&nbsp;Time&nbsp;Frame:&nbsp;baseline, 3 mo, 12 mo&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:022ceac05f15daf64eb0ae057020130e' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:d34f03e306463dbea7b65932fb39c3c2' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Modified Manchester Health Questionnaire [&nbsp;Time&nbsp;Frame:&nbsp;baseline, 3 mo, 12 mo&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:d34f03e306463dbea7b65932fb39c3c2' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:44f987dd69a53b3c0e53a08a721c1ca4' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Patient Global Impression of Improvement (PGI-I) [&nbsp;Time&nbsp;Frame:&nbsp;3 mo, 12 mo&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:44f987dd69a53b3c0e53a08a721c1ca4' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:96e62832f5514b8c4b373c0de24359f8' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>The purpose of this study is to determine whether an investigational drug, called &quot;CDP-Choline&quot;, improves memory in people with traumatic brain injury (TBI). To do this, we are asking for people with traumatic brain injury and people without traumatic brain injury to be a part of this study. We will compare results between each group to see if this investigational drug makes a difference with memory. We will also compare brain imaging results and information collected before and after the taking of the study medication to see if there are any differences. We hypothesize that there will be differences in brain activation patterns between individuals with TBI and healthy controls, as well as differences in performance on memory testing at baseline. We further hypothesize that, after treatment with CDP-Choline, the patterns in neuroimaging findings and cognitive testing results for individuals with TBI will more closely resemble results observed for healthy individuals. We hope that what we learn from this study will be helpful in the future treatment of individuals with head injury.</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:96e62832f5514b8c4b373c0de24359f8' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:d0b3b3a6ea9107249190f12d27cd519f' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>CDP-Choline and Working Memory After TBI: A Neuroimaging Study.</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:d0b3b3a6ea9107249190f12d27cd519f' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:6b293a0f1a47f45a441b66170be03aad' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Despite the prevalence of working memory deficits following traumatic brain injury (TBI), the scientific data regarding pharmacological treatment of this problem is limited. As deficits in working memory are known to have a significant impact on functional outcomes for individuals with TBI, further research in this area is essential in order for physicians to be able to treat this problem more effectively. The primary goal of the proposed project is to examine the efficacy of a particular pharmacological agent, CDP-Choline, in the treatment of working memory deficits following traumatic brain injury (TBI). The study sample will consist of 48 subjects: A group of 24 individuals who have sustained moderate to severe TBI, and a group of 24 healthy controls. Each group will be divided into a placebo and treatment group. The project will utilize functional Magnetic Resonance Imaging (fMRI) to investigate the cerebral neurophysiological effects of treatment with CDP-Choline. A working memory task (N-Back) will be employed during fMRI sessions. In addition, the effects of treatment with CDP-Choline on neuropsychological testing performance will also be evaluated, and the correlations between behavioral performance and neuroimaging results will be observed. We will achieve these goals by comparing baseline neuropsychological testing results as well as fMRI results, with a second set of testing and neuroimaging results obtained following 1 month of pharmacological treatment with CDP Choline or placebo. Based on our preliminary studies and the available literature, we expect to see the following: Baseline fMRI results are expected to show that individuals with TBI display altered patterns of cerebral activation during a working memory task, as compared to healthy controls. With CDP-Choline treatment, we expect TBI subjects to display fMRI laterality and dispersion patterns that more closely resemble patterns of healthy controls. In addition, we anticipate improvements in behavioral performance on both the specific working memory task (N-Back), and on traditional neuropsychological tests to be associated with CDP-Choline treatment, with greater magnitude of change on testing results for the TBI group as compared to any changes noted for the control or placebo groups. Finally, we anticipate that specific significant correlations will be observed between neuropsychological testing results and neuroimaging findings, and that the strength of these relationships will be greater for the TBI treatment group, as compared to the placebo or healthy control groups. By conducting the proposed study in this manner, we hope to provide scientific data that will allow for improved treatment, and ultimately improved functional outcomes for individuals who have sustained TBI.</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:6b293a0f1a47f45a441b66170be03aad' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:b51603e73670db2c24c40200f45deb5a' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria: For individuals with TBI and Health Controls:\n<ul>\n<li>right hand dominant</li>\n<li>English speaking</li>\n<li>No history of neurological illness (for example, stroke, seizure or brain tumor.</li>\n<li>No significant history of psychiatric illness (for example, schizophrenia or bipolar disorder) or current severe emotional distress.</li>\n<li>No visual difficulties that would not allow for reading and following written instructions.</li>\n<li>Free of alcohol or substance abuse.</li>\n<li>Capable of following basic written and oral instructions.</li>\n<li>Not taking certain medications that may interact with study medication or interfere with neuroimaging.</li>\n<li>Be able to take medication in tablet form, or crushed and dissolved in a liquid.</li>\n<li>Meet the additional criteria associated with MRI safety standards, as required by the University of Pittsburgh Department of Radiology. For example, these criteria include exclusion due to surgical placement of metal plates or electronic implants.</li>\n</ul>\n</p><p> In addition: Individuals with TBI must:\n<ul>\n<li>Have a specific diagnosis of a moderate to severe traumatic brain injury, which can be confirmed through review of medical records or assessments.</li>\n<li>Be at least 1 year, but no more than 3 years since injury.</li>\n<li>Must have significant working memory problems, as indicated by performance on a screening test.</li>\n</ul>\n</p><p> Normal Control subjects must:\n<ul>\n<li>Perform within the normal range on a test of working memory.</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Prisoners.</li>\n<li>Males with sexual partners who are planning to become pregnant during the treatment period.</li>\n<li>Females who are currently pregnant or who are planning to become pregnant during the treatment period.</li>\n<li>Individuals who are currently enrolled in another medication study</li>\n<li>Individuals who are currently, or have previously been, treated with CDP-Choline (Citicoline) for research or clinical purposes.</li>\n<li>Currently in a nursing home in the state of Pennsylvania.</li>\n</ul>\n</p>', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:b51603e73670db2c24c40200f45deb5a' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:0c06ee327de6ddca20c52201bf5f7b0f' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>The primary objective of this trial is to determine whether written educational materials plus brief education by telephone will help patients better understand and participate in the decision on how many embryos to transfer to the uterus during treatment of infertility with in vitro fertilization (IVF). The main study hypothesis is that women and men who receive the study\'s educational intervention will experience favorable changes in knowledge and beliefs about benefits, susceptibility and severity of multiple gestation that impact decisions about the number of embryos to transfer. Secondary objectives are to understand patient beliefs, knowledge and information preferences regarding other possible risks of IVF, to compare perception of IVF-related risks to familiar risks that are included in routine preconception health promotion, and during IVF, and to prepare couples to manage IVF-related obstetrical risks when they make the transition to prenatal care after becoming pregnant. Medical Treatment Coverage: None, this study does not provide any monetary contribution to medical treatment</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:0c06ee327de6ddca20c52201bf5f7b0f' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:d32c9e155bb82420f1f9a143078898b6' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Improving Communication With IVF Patients About Risks Such as Multiple Births</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:d32c9e155bb82420f1f9a143078898b6' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:7d1f9ae76cefdcf9f49536c4bf1049a4' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>The long-term objective of this research is to improve patient understanding of the known and strongly suspected risks from treating infertility with assisted reproductive technologies such as in vitro fertilization (IVF). During IVF, when more embryos are transferred to the uterus, the risk of pregnancy with multiple fetuses increases. In addition, single infants conceived with IVF are at greater risk for low birth weight. This study will promote behaviors that may reduce these risks. One in 3 women who completes a pregnancy conceived with assisted reproductive technologies such as IVF delivers multiples, and these treatments produce over 12,000 multiple birth deliveries annually in the United States. This study will lead to a better understanding of the most effective ways to counsel IVF patients about the embryo transfer decision. This study will also help define how to prepare IVF patients to work most effectively with their prenatal care team to manage IVF-related obstetrical risks. Medical Treatment Coverage: None, this study does not provide any monetary contribution to medical treatment</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:7d1f9ae76cefdcf9f49536c4bf1049a4' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:a1cf91c0d0a34f0477f51bd44f91f8a7' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ul>\n<li>At least 18 years of age</li>\n<li>Not using a gestational carrier in the current cycle of IVF</li>\n</ul>\n</p>', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:a1cf91c0d0a34f0477f51bd44f91f8a7' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:1f96993880038c40fd9435aee99d6f4f' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>More than 1.5 million deaths of African children under 5 years of age have been due to Plasmodium falciparum malaria. When HIV and malaria are present as coinfections, they enhance each other\'s progression. The primary purpose of this study is to compare the malarial infection levels in HIV-infected infants and children receiving protease inhibitor (PI)- or non-nucleotide reverse transcriptase inhibitor (NNRTI)-based highly active antiretroviral therapy (HAART).</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:1f96993880038c40fd9435aee99d6f4f' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:8234d02d5a5dd8b2e3335b2419e1e67f' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>P1060 Substudy Comparing Differences in Malaria Parasitemia by Real Time Quantitative PCR in HIV-Infected Infants and Children on PI-Based HAART Versus NNRTI-Based HAART</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:8234d02d5a5dd8b2e3335b2419e1e67f' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:85021526298786eedac247d062b1e4a8' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>The World Health Organization (WHO) reports 1 to 2 million malaria deaths annually, with most malaria-related deaths occurring in children. The malaria burden is compounded by the HIV epidemic, which is most prevalent in areas endemic for malaria, notably Sub-Saharan Africa where nine in ten children younger than 15 years of age are infected with HIV. The purpose of this study is to compare parasitemia levels in HIV-infected infants and children receiving PI- or NNRTI-based HAART regimens. This study will enroll a total of 140 participants, 35 from each of the 4 groups in IMPAACT P1060. This substudy will last until 24 weeks after the last P1060 enrollment or until P1060 study discontinuation. Participants must meet enrollment criteria for P1060 as well as additional criteria for this study. Study visits will occur as a part of P1060 study visits, all of which include a physical exam, blood collection, and assessments of HIV-related symptoms. Participants are also encouraged to return to the primary clinic site for intercurrent illness visits for assessment, thick and thin blood smear, and filter paper blood collection, however these visits are not mandatory for study participation.</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:85021526298786eedac247d062b1e4a8' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:381295db8f5603cbd4bf113e234a90d9' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ul>\n<li>Enrolling in study IMPAACT P1060</li>\n<li>Parent/legal guardian agrees to seek medical care for intercurrent illness at the study site, whenever possible, and agree to not use at-home remedies for febrile illness in the child</li>\n</ul>\n</p>', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:381295db8f5603cbd4bf113e234a90d9' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:ac7b42d8a6ca4119bfc950ef41286955' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Time of initiation of treatment for clinical malaria requiring conventional anti-malarial therapy [&nbsp;Time&nbsp;Frame:&nbsp;Throughout study&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:ac7b42d8a6ca4119bfc950ef41286955' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:6d03849f4f85c16f18bd6ea531141ed5' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Severity of malarial disease [&nbsp;Time&nbsp;Frame:&nbsp;Throughout study&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:6d03849f4f85c16f18bd6ea531141ed5' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:0f1647a990276829726e0409bd5e2650' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Measured anti-malaria IgG, protein in plasma, and mRNA transcripts in PBMC of chemokines [&nbsp;Time&nbsp;Frame:&nbsp;Throughout study&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:0f1647a990276829726e0409bd5e2650' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:d99a92c713103e00334fa529383ed4d2' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>IL4-589C/T genotypes [&nbsp;Time&nbsp;Frame:&nbsp;Throughout study&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:d99a92c713103e00334fa529383ed4d2' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:ccf9d72f833de0c597dcae91d7983edc' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>The primary research hypothesis is that ovulation induction with an aromatase inhibitor (letrozole) is more likely to result in live birth than ovulation induction with a selective estrogen receptor modulator (clomiphene citrate) in infertile women with PCOS. A safety hypothesis will also be incorporated into the primary research hypothesis in which we hypothesize both treatments are equally safe for mother and child. Secondary research hypotheses include:\n<ol>\n<li>Treatment with letrozole is more likely to result in singleton pregnancy compared to treatment with clomiphene citrate. Singleton pregnancy is defined as presence of a single intrauterine gestational sac with a single fetal pole and observable heart motion.</li>\n<li>Treatment with letrozole will less likely result in a first trimester intrauterine fetal demise than treatment with clomiphene citrate. A first trimester IUFD is defined as a pregnancy that ends before 13 weeks gestation.</li>\n<li>Treatment with letrozole is more likely to result in ovulation (increased ovulation rate) compared to treatment with clomiphene citrate. Ovulation is defined as a midluteal progesterone level &#8805; 3 ng/mL.</li>\n<li>The shortest time to pregnancy will be with letrozole.</li>\n<li>Age, body mass index, SHBG, testosterone, LH, Anti-Mullerian Hormone (AMH), and degree of hirsutism and acne will be significant predictors of ovulation and conception regardless of treatment.</li>\n<li>Improvement in SHBG, testosterone, AMH, and LH levels will be significant predictors of ovulation and conception regardless of treatment.</li>\n<li>DNA polymorphisms in estrogen action genes will predict response to study drug.</li>\n<li>Quality of Life will be better on letrozole than clomiphene.</li>\n<li>Letrozole will be more cost effective at achieving singleton pregnancies than clomiphene.</li>\n</ol>\n</p>', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:ccf9d72f833de0c597dcae91d7983edc' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>A 20 Week Double-Blind Randomized Trial of Clomiphene Citrate and Letrozole for the Treatment of Infertility in Women With Polycystic Ovary Syndrome</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:b7feca63608509c9624216e983b739fa' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:8d7a44db7f889189990f5b33dc1f66fd' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Preliminary data are promising for the use of letrozole to induce ovulation in infertile women with PCOS. However the true magnitude of the effect of letrozole is difficult to discern from prior studies. Therefore we intend to determine the safety and efficacy of letrozole, an aromatase inhibitor, compared to clomiphene citrate, a selective estrogen receptor modulator, in achieving live birth in infertile women with PCOS. Treatment- After progestin withdrawal, 750 women will be equally randomized to two different treatment arms: A) clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle), or B) letrozole 2.5 mg every day for 5 days (day 3-7 of cycle), for a total of 5 cycles or 20 weeks. Dose will be increased in subsequent cycles in both treatment groups for non-response or poor ovulatory response up to a maximum of 150 mg of clomiphene a day (x 5 days) or 7.5 mg of letrozole a day (x 5 days). Statistical Analysis- The primary analysis will use an intent-to-treat approach to examine differences in the live birth rate in the two treatment arms. Anticipated time to completion- A total of 4 years will be required to complete the study after start up; 31 month enrollment period, 5 month treatment period, with 9 month additional observation to determine pregnancy outcomes. This will be accomplished by enrolling ~3.45 women with PCOS per center per month over the enrollment period (N = 7 RMN sites).</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:8d7a44db7f889189990f5b33dc1f66fd' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:947eea789ebb423750e7ab4ba0f05cff' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>The patient population will consist of 750 infertile women with PCOS with ovulatory dysfunction and either one of the remaining two criteria, hyperandrogenism (clinical or biochemical) or polycystic ovaries on ultrasound, with exclusion of secondary causes of PCOS. Additionally, the couple will have no other major infertility factor, and the subject will have at least one patent fallopian tube and a normal uterine cavity, and a partner with a sperm concentration of 14 million/mL in at least one ejaculate. Inclusion Criteria:\n<ul>\n<li>Key Inclusion Criteria (Must have ovulatory dysfunction and either hyperandrogenism or PCO)\n<ol>\n<li>Chronic anovulation or oligomenorrhea: defined as spontaneous intermenstrual periods of &#8805;45 days or a total of &#8804;8 menses per year, or for women with suspected anovulatory bleeding, a midluteal serum progesterone level &lt; 3 ng/dL is indicative of chronic anovulation. For women who have been on ovarian suppressive therapy or other confounding medication (i.e. insulin sensitizing agents) within the last year prior to the study, a history of &#8804;8 menses per year prior to the initiation of this prior therapy will qualify as evidence of oligomenorrhea. For women with more regular bleeding patterns, but who are suspected to be experiencing anovulatory bleeding, a midluteal progesterone level &lt; 3ng/dL will be evidence of ovulatory dysfunction and qualify as anovulation.</li>\n<li>Hyperandrogenism (either Hirsutism or Hyperandrogenemia) or Polycystic Ovaries on Ultrasound:\n<ol>\n<li>Hirsutism is determined by a modified Ferriman-Gallwey Score &gt;8 at screening exam (Hatch, Rosenfield et al. 1981 Aug 1). Subjects who have hirsutism do not need local or core labs documenting elevated androgen levels.</li>\n<li>Hyperandrogenemia will be defined as an elevated total testosterone, or free androgen index (FAI). Outside lab values obtained within the last year documenting elevated T or FAI levels are sufficient to meet criteria of hyperandrogenemia.</li>\n<li>Polycystic Ovaries on Ultrasound: PCO will be defined as either an ovary that contains 12 or more follicles measuring 2-9 mm in diameter, or an increased ovarian volume (&gt; 10 cm3) on one ovary for entry into the study. If there is a follicle &gt; 10 mm in diameter, the scan should be repeated at a time of ovarian quiescence in order to calculate volume and area if the subject does not otherwise qualify for the study. The presence of a single polycystic ovary (PCO), either by volume or morphology, is sufficient to provide the diagnosis.</li>\n</ol>\n</li>\n</ol>\n</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>We will exclude subjects with medical conditions that represent contraindications to CC, aromatase inhibitors and/or pregnancy or who are unable to comply with the study procedures. We will exclude subjects with poorly controlled Type 1 or 2 diabetes; undiagnosed liver disease or dysfunction (based on serum liver enzyme testing); renal disease or abnormal serum renal function; significant anemia; history of deep venous thrombosis, pulmonary embolus, or cerebrovascular accident; uncontrolled hypertension, known symptomatic heart disease; history of or suspected cervical carcinoma, endometrial carcinoma, or breast carcinoma; undiagnosed vaginal bleeding, and use of other medications known to affect reproductive function or metabolism (e.g., OCP, GnRH agonists and antagonists, anti-androgens, gonadotropins, anti-obesity drugs, somatostatin, diazoxide, ACE inhibitors, and calcium channel blockers). As in PPCOS we will allow a 3 mos washout period for subjects who desire to participate and discontinue exclusionary medications (most commonly OCP, but also possibly metformin), and a period of observation or treatment for correctable conditions.</li>\n</ul>\n</p>', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:947eea789ebb423750e7ab4ba0f05cff' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:5112bca7bc825e6de59b93d52d702278' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Singleton live birth rate [&nbsp;Time&nbsp;Frame:&nbsp;September 2008 - December 2011&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:5112bca7bc825e6de59b93d52d702278' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Abortion rate [&nbsp;Time&nbsp;Frame:&nbsp;September 2008 - December 2011&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:965332002a2956067d8d74f62d9b274c' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Time to pregnancy [&nbsp;Time&nbsp;Frame:&nbsp;September 2008 - December 2011&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:bac76257a0ba312877551caefee114cb' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Ovulation rate [&nbsp;Time&nbsp;Frame:&nbsp;September 2008 - December 2011&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:59367f0aaeecafae8adf4a21e865fbc6' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Pregnancy complication rate [&nbsp;Time&nbsp;Frame:&nbsp;September 2008 - December 2011&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:5a1f98f17d444de5c88953bcd4edba4c' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Birth weight [&nbsp;Time&nbsp;Frame:&nbsp;September 2008 - December 2011&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:609d4751fa78026fd6ab1909934efd31' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Neonatal complication rate [&nbsp;Time&nbsp;Frame:&nbsp;September 2008 - December 2011&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:9102bebb5f33073dd2d3f72795dbeee6' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>DNA polymorphisms [&nbsp;Time&nbsp;Frame:&nbsp;September 2008 - December 2011&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:99ce3772a1c0b5ee75c2e1e866a080a7' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Quality of life [&nbsp;Time&nbsp;Frame:&nbsp;September 2008 - December 2011&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:c033c5bd797e511c839a86c9d32baea3' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Cost effectiveness [&nbsp;Time&nbsp;Frame:&nbsp;September 2008 - December 2011&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283569506, expire = 1283655906, headers = '', serialized = 0 WHERE cid = '1:b253f008dfc7a4c34cd7ca259b551c04' in /persistent/html/includes/cache.inc on line 109.

CEP-1 Hormonal Regulation of Circulating Endothelial Progenitor Cells

Trial phase: 
Phase II
Recruitment status: 
Recruiting

The purpose of this research study is to understand the effects of testosterone (T) and estrogen on stem cells in the blood. The knowledge will be used to help understand the effects of T and estrogen on cardiovascular (heart and blood vessel) disease. The knowledge will also be used to help in the development of a safe male hormonal contraceptive.

Background information
Trial ID: 
NCT00729859
Other unique IDs: 
33853-A
Official title: 

Hormonal Regulation of Circulating Endothelial Progenitor Cells and HDL-C in Men

Detailed description: 

We will be administering three drugs: Testim (testosterone gel) anastrozole and acyline. We want to see their effects on stem cells and hormone levels in the blood. Acyline suppress LH (luteinizing hormone) and FSH (follicle-stimulating hormone), which are hormones made by the pituitary gland, thus blocking the signal from the brain that causes the testes to make testosterone. Therefore acyline blocks testosterone production. Some men may experience side effects such as hot flashes or irritability from the low levels of T caused by acyline.

Number to be enrolled: 
24 patients
Acronym: 
CEP-1

Air Muscle and Task Practice in Upper Limb Stroke Rehab

Trial phase: 
Phase 0
Recruitment status: 
Completed

Many patients who have sustained strokes are unable to effectively use their hemiparetic upper extremity. Limited mobility in the performance of daily activities, such as eating or dressing, adversely affects their quality of life and compromises independence. Rehabilitation techniques engaging the hemiparetic limb in repetitive task practice (RTP) may improve upper extremity function and quality of life in patients with stroke, but costs limit the number of patients that can utilize this type of therapy. Advances in microprocessor design and function make the use of an assistive device as an adjunct to RTP plausible. An innovative assistive repetitive motion (ARM) device using an "air muscle" has been developed specifically for the rehabilitation of the hemiparetic upper extremity. The primary aim of the proposed study is to collect pilot data to estimate the clinical effectiveness of using the ARM device in conjunction with RTP to improve upper extremity motor function and the quality of life of patients with stroke. Twenty sub-acute (3 to 9 mos. post-stoke) patients will be randomized to a RTP only or ARM + RTP group. The RTP group will receive 15 days (4 hours per day) of intensive one-on-one RTP therapy. The ARM + RTP group will use the ARM device for 2 hours per day and receive 2 hours of intensive RTP per day for 15 days. Clinical motor function and quality of life measures will be taken before and after the interventions and two months later. We hypothesize that the ARM + RTP group will exhibit greater improvements in motor function and quality of life measures than the RTP only group.

Background information
Trial ID: 
NCT00729625
Other unique IDs: 
R21HD045514
7R21HD045514-03
Official title: 

Air Muscle and Task Practice in Upper Limb Stroke Rehab

Detailed description: 

Specific Aim 1: Estimate the effectiveness of using an assistive repetitive motion device (ARM) in conjunction with repetitive task practice (RTP) on motor recovery of patients with sub-acute stroke. This aim will be examined by comparing pre-intervention motor performance levels with the immediate post-intervention and two months post-intervention. The primary outcome variables will be scores on the Fugl-Meyer Motor Assessment Test (FMA) and Wolf Motor Function Test (WMFT).

Number to be enrolled: 
24 patients

Effects of Flutamide on Insulin and Glucose Metabolism in Women With Polycystic Ovary Syndrome

Recruitment status: 
Recruiting

PCOS is the major cause of infertility in the United States. Many women with PCOS demonstrate insulin resistance and a compensatory hyperinsulinemia.This is due to both an intrinsic form of insulin resistance unique to PCOS and, in many cases, acquired insulin resistance due to obesity. The importance of this observation lies in the fact that hyperinsulinemia appears to play an important pathogenetic role in the hyperandrogenism and anovulation of both obese and lean women with PCOS.

Background information
Trial ID: 
NCT00729560
Other unique IDs: 
04487VCUIRB
GCRC0826
Official title: 

Determination if Pharmacologic Blockade of Androgen Action Decreases Renal Clearance of DCI, Increases the Circulating Concentration of DCI, and Enhances Insulin-Stimulated Release of the DCI-IPG Mediator in Obese Women With PCOS

Detailed description: 

Hyperinsulinemia stimulates ovarian production of androgens, especially testosterone, in PCOS. Therefore, it is theoretically possible that testosterone increases uClDCI in PCOS, and that this serves as the explanation for the correlation between uClDCI and insulin sensitivity. While we regard this possibility as unlikely, it is important that it be tested. To accomplish this, we will assess obese (BMI >30 kg/m2) women with and without PCOS at baseline, and again after 4 weeks of androgen action blockade with the drug flutamide.

Number to be enrolled: 
66 patients
Acronym: 
PCOS

Women-Focused HIV Prevention in the Western Cape

Trial phase: 
Phase III
Recruitment status: 
Recruiting

The purpose of this study is to test the effectiveness of a woman-focused HIV prevention intervention combined with voluntary counseling and testing (VCT), compared to VCT only, and VCT combined with an attention-control nutrition intervention.

Background information
Trial ID: 
NCT00729391
Other unique IDs: 
R01HD058320
Official title: 

 

Detailed description: 

Surveillance data indicate that HIV risk and substance use is a serious problem among South African women. This study, funded by the National Institute on Child Health and Human Development (NICHD), builds on findings from a recently completed pilot study among women in less affluent townships and communities in the Western Cape (Wechsberg et al., 2008). The pilot study tested the effectiveness of an evidence-based woman-focused intervention in reducing drug use, sexual risk, and victimization by addressing the intersection of these factors among 100 poor, substance-using women of colour.

Number to be enrolled: 
900 patients

Jump-In - Building Better Bones

Recruitment status: 
Recruiting

The Jump-In study will prospectively assess the effects of impact exercise on skeletal development in young girls, including bone mass, bone mineral density, and bone geometry. We hypothesize that girls who regularly participate in impact loading exercise will accrue greater skeletal mass, increase bone density and undergo structural adaptations that in combination will improve bone strength compared to girls who do not participate in impact exercise.

Background information
Trial ID: 
NCT00729378
Other unique IDs: 
HD050775
Official title: 

Exercise and Bone Development in Young Girls

Detailed description: 

Jump-In is a school-based, block-randomized, trial of the effects of impact-loading exercise on skeletal development in prepubescent and early pubescent girls. Fourth (n=~200) and sixth (n=~200) grade girls in 14 Tucson (Arizona) schools with no contraindication to physical exercise will be enrolled. Girls in intervention schools will participate in impact activities 3 times per week at school, progressively increasing the number (up to 40) of jumps and their height (from 6 inches to 18 inches per repetition) over the initial 2 months.

Number to be enrolled: 
400 patients

Adaptive Behaviors Among Women With Bowel Incontinence: The ABBI Trial

This study focuses on the validation of the Adaptation Index instrument as a measurement of adaptive behaviors used to reduce symptoms of FI and to describe the use of adaptive behaviors among women with FI.

Background information
Other unique IDs: 
1J06-FI
U01 HD41249
U10 HD41250
U10 HD41261
U10 HD41267
U10 HD54136
U10 HD54214
U10 HD54215
U10 HD54241

CDP-Choline and Working Memory After TBI: A Neuroimaging Study

Trial phase: 
Phase II
Recruitment status: 
Not yet recruiting

The purpose of this study is to determine whether an investigational drug, called "CDP-Choline", improves memory in people with traumatic brain injury (TBI). To do this, we are asking for people with traumatic brain injury and people without traumatic brain injury to be a part of this study. We will compare results between each group to see if this investigational drug makes a difference with memory. We will also compare brain imaging results and information collected before and after the taking of the study medication to see if there are any differences. We hypothesize that there will be differences in brain activation patterns between individuals with TBI and healthy controls, as well as differences in performance on memory testing at baseline. We further hypothesize that, after treatment with CDP-Choline, the patterns in neuroimaging findings and cognitive testing results for individuals with TBI will more closely resemble results observed for healthy individuals. We hope that what we learn from this study will be helpful in the future treatment of individuals with head injury.

Background information
Trial ID: 
NCT00727246
Other unique IDs: 
PRO07020121
K23HD049626
Official title: 

CDP-Choline and Working Memory After TBI: A Neuroimaging Study.

Detailed description: 

Despite the prevalence of working memory deficits following traumatic brain injury (TBI), the scientific data regarding pharmacological treatment of this problem is limited. As deficits in working memory are known to have a significant impact on functional outcomes for individuals with TBI, further research in this area is essential in order for physicians to be able to treat this problem more effectively.

Number to be enrolled: 
48 patients

Communication With in Vitro Fertilization (IVF) Patients About Risks

Recruitment status: 
Recruiting

The primary objective of this trial is to determine whether written educational materials plus brief education by telephone will help patients better understand and participate in the decision on how many embryos to transfer to the uterus during treatment of infertility with in vitro fertilization (IVF). The main study hypothesis is that women and men who receive the study's educational intervention will experience favorable changes in knowledge and beliefs about benefits, susceptibility and severity of multiple gestation that impact decisions about the number of embryos to transfer. Secondary objectives are to understand patient beliefs, knowledge and information preferences regarding other possible risks of IVF, to compare perception of IVF-related risks to familiar risks that are included in routine preconception health promotion, and during IVF, and to prepare couples to manage IVF-related obstetrical risks when they make the transition to prenatal care after becoming pregnant. Medical Treatment Coverage: None, this study does not provide any monetary contribution to medical treatment

Background information
Trial ID: 
NCT00722618
Other unique IDs: 
220060957
1R21HD053459-01A1
Official title: 

Improving Communication With IVF Patients About Risks Such as Multiple Births

Detailed description: 

The long-term objective of this research is to improve patient understanding of the known and strongly suspected risks from treating infertility with assisted reproductive technologies such as in vitro fertilization (IVF). During IVF, when more embryos are transferred to the uterus, the risk of pregnancy with multiple fetuses increases. In addition, single infants conceived with IVF are at greater risk for low birth weight. This study will promote behaviors that may reduce these risks.

Number to be enrolled: 
260 patients

Differences in Malaria Infection Levels in HIV-Infected Infants and Children Receiving PI- and NNRTI-Based HAART

Trial phase: 
Phase 0
Recruitment status: 
Not yet recruiting

More than 1.5 million deaths of African children under 5 years of age have been due to Plasmodium falciparum malaria. When HIV and malaria are present as coinfections, they enhance each other's progression. The primary purpose of this study is to compare the malarial infection levels in HIV-infected infants and children receiving protease inhibitor (PI)- or non-nucleotide reverse transcriptase inhibitor (NNRTI)-based highly active antiretroviral therapy (HAART).

Background information
Trial ID: 
NCT00719602
Other unique IDs: 
IMPAACT P1068s
PACTG P1068s
Official title: 

P1060 Substudy Comparing Differences in Malaria Parasitemia by Real Time Quantitative PCR in HIV-Infected Infants and Children on PI-Based HAART Versus NNRTI-Based HAART

Detailed description: 

The World Health Organization (WHO) reports 1 to 2 million malaria deaths annually, with most malaria-related deaths occurring in children. The malaria burden is compounded by the HIV epidemic, which is most prevalent in areas endemic for malaria, notably Sub-Saharan Africa where nine in ten children younger than 15 years of age are infected with HIV. The purpose of this study is to compare parasitemia levels in HIV-infected infants and children receiving PI- or NNRTI-based HAART regimens. This study will enroll a total of 140 participants, 35 from each of the 4 groups in IMPAACT P1060.

Number to be enrolled: 
140 patients

Pregnancy in Polycystic Ovary Syndrome II

Trial phase: 
Phase III
Recruitment status: 
Recruiting

The primary research hypothesis is that ovulation induction with an aromatase inhibitor (letrozole) is more likely to result in live birth than ovulation induction with a selective estrogen receptor modulator (clomiphene citrate) in infertile women with PCOS. A safety hypothesis will also be incorporated into the primary research hypothesis in which we hypothesize both treatments are equally safe for mother and child. Secondary research hypotheses include:

  1. Treatment with letrozole is more likely to result in singleton pregnancy compared to treatment with clomiphene citrate. Singleton pregnancy is defined as presence of a single intrauterine gestational sac with a single fetal pole and observable heart motion.
  2. Treatment with letrozole will less likely result in a first trimester intrauterine fetal demise than treatment with clomiphene citrate. A first trimester IUFD is defined as a pregnancy that ends before 13 weeks gestation.
  3. Treatment with letrozole is more likely to result in ovulation (increased ovulation rate) compared to treatment with clomiphene citrate. Ovulation is defined as a midluteal progesterone level ≥ 3 ng/mL.
  4. The shortest time to pregnancy will be with letrozole.
  5. Age, body mass index, SHBG, testosterone, LH, Anti-Mullerian Hormone (AMH), and degree of hirsutism and acne will be significant predictors of ovulation and conception regardless of treatment.
  6. Improvement in SHBG, testosterone, AMH, and LH levels will be significant predictors of ovulation and conception regardless of treatment.
  7. DNA polymorphisms in estrogen action genes will predict response to study drug.
  8. Quality of Life will be better on letrozole than clomiphene.
  9. Letrozole will be more cost effective at achieving singleton pregnancies than clomiphene.

Background information
Trial ID: 
NCT00719186
Other unique IDs: 
RMN-PPCOSII
Official title: 

A 20 Week Double-Blind Randomized Trial of Clomiphene Citrate and Letrozole for the Treatment of Infertility in Women With Polycystic Ovary Syndrome

Detailed description: 

Preliminary data are promising for the use of letrozole to induce ovulation in infertile women with PCOS. However the true magnitude of the effect of letrozole is difficult to discern from prior studies. Therefore we intend to determine the safety and efficacy of letrozole, an aromatase inhibitor, compared to clomiphene citrate, a selective estrogen receptor modulator, in achieving live birth in infertile women with PCOS.

Number to be enrolled: 
750 patients
Acronym: 
PPCOSII
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