Active Control

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The Absorption of Vitamin B12 Among Healthy Pregnant Women

Recruitment status: 
Recruiting

During pregnancy the woman uses more vitamin B12, but we do not know, whether it is through increased absorption or it eats into the womans vitamin B12 deposit . Sufficient B-vitamin is crucial for the normal development af foetus during pregnancy. In Denmark the National Board of Health recommend an intake of Folic Acid, from the day the woman wishes to be pregnant and to the 12. week of gestation, but there is no recommendation for vitamin B12. We will measure the vitamin B12 absorption with a new non-radioactive test, CobaSorb. .

Background information
Trial ID: 
NCT00730093
Other unique IDs: 
BH12008
Official title: 

The Absorption of Vitamin B12 Among Healthy Pregnant Women

Detailed description: 

 

Number to be enrolled: 
102 patients

Oral Versus Rectal Ibuprofen for Fever in Young Children - a Randomized Control Study.

Fever is one of the most common symptoms in pediatrics and one of the most common reasons for visits in pediatricians' office and pediatric emergency departments. Many parents consider fever to be the most terrifying symptom. Ibuprofen is an effective and safe treatment for febrile children. Until recently ibuprofen was available only in tablets suspension and as a liquid gel. All these dosage form are administered orally. Rectal suppositories are often essential for treating febrile children who cannot take medications by mouth (e.g vomiting). In the current study we aim to compare the effect on fever of ibuprofen given as suspension with ibuprofen suppositories.

Background information
Other unique IDs: 
091/08

Study to Evaluate the Use of Polyethylene Terepthalate (PET) Implants for the Treatment of External Nasal Valve Collapse (NVC)

Trial phase: 
Phase I
Recruitment status: 
Recruiting

The purpose of this study is to research a new implant for the treatment of external nasal valve collapse (NVC). NVC is a condition which causes narrowness and weakness in the nostril which results in nasal obstruction. Implants will be placed in the affected nostril(s). The implants are intended to restore the shape and stabilize the nasal wall to prevent nasal valve collapse and improve the symptoms associated with nasal obstruction.

Background information
Trial ID: 
NCT00729781
Other unique IDs: 
925
Official title: 

Open Label, Baseline Controlled Study to Evaluate the Use of Polyethylene Terepthalate (PET) Implants for the Treatment of External Nasal Valve Collapse and Cosmetic Contour Deformity

Detailed description: 

This study is designed to evaluate a new polyethylene terepthalate implant for the treatment of uni-lateral and bilateral external nasal valve collapse and cosmetic contour deformity. The focus of this investigation will be to specifically address the lateral components of nasal valve collapse caused by weakened, distorted, or absent mechanical strength of the nasal cartilages or their fibrous attachments within the lateral nasal sidewall and nasal ala.

Number to be enrolled: 
72 patients
Acronym: 
NVC

A Study to Evaluate Efalizumab Compared With Cyclosporine As an Immunosuppressant Regimen in De Novo Renal Transplantation

Trial phase: 
Phase III
Recruitment status: 
Withdrawn

This is a Phase II/III, randomized, open-label, active-controlled, multicenter trial to evaluate the safety and efficacy of efalizumab compared with cyclosporine (CsA), when both are given in combination with Mycophenolate Mofetil (MMF) and corticosteroids after induction therapy with basiliximab, as an immunosuppressant regimen in de novo renal transplantation. A total of 200 subjects undergoing either living or cadaveric renal transplantation will be randomly assigned 1:1 to receive either efalizumab + MMF + corticosteroids or CsA + MMF + corticosteroids.

Background information
Trial ID: 
NCT00729768
Other unique IDs: 
ACD4230g
Official title: 

A Phase II/III, Randomized, Open-Label, Active Controlled, Multicenter Trial to Evaluate the Safety and Efficacy of Efalizumab Compared With Cyclosporine, Both in Combination With Mycophenolate Mofetil and Corticosteroids, As an Immunosuppressant Regimen

Detailed description: 

 

Number to be enrolled: 
200 patients

Optimal Anti-Tachycardia Therapy in Implantable Cardioverter-Defibrillator (ICD) Patients Without Pacing Indications

Trial phase: 
Phase IV
Recruitment status: 
Recruiting

This study evaluates the impact of a new pacing mode avoiding unnecessary ventricular stimulation in combination with advanced dual chamber detection with slow VT management on the clinical outcome for hospitalization and mortality and inadequate therapy in medically stable, ICD-indicated patients with impaired left ventricular function (LVEF ≤ 40%) who do not have pacing indications and no indication for Cardiac Resynchronization Therapy (CRT). It compares a new pacing mode avoiding ventricular stimulation when not needed combined with dual chamber detection with a pure ventricular back up pacing and single chamber detection criteria with pure ventricular back up pacing. Therapies are compared in a prospective, randomized, single-blinded, parallel trial with a 24-month randomized treatment period. Randomization follows a 1:1 ratio. ICD therapy is enabled for all patients throughout the study. All patients receive optimal drug therapy for arrhythmia and heart failure treatment.

Background information
Trial ID: 
NCT00729703
Other unique IDs: 
OPTION - ITAC03
Official title: 

Optimal Antitachycardia Therapy in ICD Patients Without Pacing Indications

Detailed description: 

All patients will receive an implantable cardioverter defibrillator OVATIO™ DR model 6550 or a later Sorin Group device offering the same functions. After Enrolment visit but before implant, patients will be randomized in two arms according to the parallel study design. Whenever possible before implant there will be the first Holter recording for the Tvar risk stratification procedure. In case Tvar recording could not be performed before implant it has to be performed before patient leaves the hospital post implant in unpaced rhythm.

Number to be enrolled: 
450 patients
Acronym: 
OPTION

Efficacy and Safety Study of FOSAMAX PLUS D in Postmenopausal Women With Osteoporosis

Trial phase: 
Phase III
Recruitment status: 
Completed

To demonstrate the efficacy/safety of FOSAMAX PLUS D.

Background information
Trial ID: 
NCT00729651
Other unique IDs: 
2008_015
MK217A-263
Official title: 

A Phase IV (Phase V Program), Prospective, Randomized, Open-Label, Active-Controlled, Clinical Trial to Study the Efficacy and Safety of FOSAMAX PLUS D in Postmenopausal Women With Osteoporosis

Detailed description: 

 

Number to be enrolled: 
350 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

Role of Mosapride in Patients With Gastroesophageal Reflux Disease

Trial phase: 
Phase IV
Recruitment status: 
Completed

Gastroesophageal reflux disease (GERD) is a very common disease in the Western World. In Taiwan, this disease is increasing gradually because the investigators' eating style is closing to Western world. Proton pump is the main drug for patients with GERD in the past two decades. Prokinetic agent is an important adjuvant to the therapy of GERD. This study aims to evaluate the role of prokinetic agent in the management of GERD.

Background information
Trial ID: 
NCT00729339
Other unique IDs: 
OMCP-97-011
Official title: 

Role of Mosapride in Patients With Gastroesophageal Reflux Disease

Detailed description: 

This is a randomized, double-blind, cross-over study. FSSG is obtained at the beginning, one month and two months of the study. This study plans to enroll 100 patients with symptoms of GERD (acid regurgitation, belching, dysphagia). After receiving endoscopic examination, a frequent scale for the symptoms of gastroesophageal reflux disease (FSSG) is obtained from these patients. Fifty patients receive lansoprazole 30 mg once plus mosapride 5 mg tid daily in the first month; and lansoprazole 30 mg once plus placebo tid daily in the second month.

Number to be enrolled: 
114 patients

Comparison of the Effect of Exenatide Versus Sitagliptin on 24-Hour Average Glucose in Patients With Type 2 Diabetes on Metformin or a Thiazolidinedione

Trial phase: 
Phase IV
Recruitment status: 
Not yet recruiting

This study is designed to compare the short-term effects and mechanisms of action of exenatide with those of sitagliptin when either is added to an oral agent(metformin or a thiazolidinedione [TZD]) in adult patients with type 2 diabetes mellitus(T2DM) with inadequate glycemic control.

Background information
Trial ID: 
NCT00729326
Other unique IDs: 
H8O-US-GWCV
Official title: 

Comparison of the Effect of Exenatide vs. Sitagliptin on 24-Hour Average Glucose in Patients With Type 2 Diabetes on Metformin or a Thiazolidinedione

Detailed description: 

 

Number to be enrolled: 
64 patients

Biventricular Tachycardias Outcome Trial

Trial phase: 
Phase IV
Recruitment status: 
Recruiting

This clinical investigation is a device-based open, prospective, multicenter two-arm randomized trial, comparing patients who are treated in the slow VT zone versus patients who are not treated in that zone. The device intended to be used is the OVATIOTM CRT model 6750 but future generation of Sorin Group/ ELA Medical devices may be used provided they are CE marked. Ethics committees and health authorities will be informed prior to any use of a newer device if applicable. All patients will have a 3-zone detection configuration programmed. The slow VT zone will be defined by programming the detection parameters as follows:

  • Slow VT detection rate: 100 bpm (or if the resting rate is higher than 80 bpm, we recommend to adjust this parameter to: resting rate + 30 bpm)
  • VT detection rate: 150 bpm

PARAD+ will be the first choice for SVT/ST and VT discrimination in the VT zones. The Fast VT and VF limits are left to investigator's judgment. Therapy on VT, fast VT and VF are also left to the investigator's judgment. Patients will be randomized at implant to have the slow VT zone programmed as a monitoring zone (monitoring arm) or to have therapies programmed within the slow VT zone (therapy arm). The randomization table will be generated by Sorin Group/ELA Medical.

Background information
Trial ID: 
NCT00729235
Other unique IDs: 
BITAC - ITAC04
Official title: 

Biventricular Tachycardias Outcome Trial

Detailed description: 

 

Number to be enrolled: 
404 patients
Acronym: 
BITAC
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