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

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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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