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Clinical Trials About "Group sequential designs produce reliable results preclinical trials" RSS

23:02 EST 21st November 2017 | BioPortfolio

We list hundreds of Clinical Trials about "Group sequential designs produce reliable results preclinical trials" on BioPortfolio. We draw our references from global clinical trials data listed on ClinicalTrials.gov and refresh our database daily.

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Showing "Group sequential designs produce reliable results preclinical trials" Clinical Trials 1–25 of 16,000+

Tuesday 21st November 2017

Investigation of Post-surgical Aortic Hemodynamics After Aortic Valve Replacement

The purpose of this pilot study is to obtain both near valve and downstream flow characteristics, using 3D transthoracic echocardiography and 4D flow MRI respectively, in an existing patient population at Northwestern Memorial Hospital, to determine the hinge washout characteristics and downstream flow patterns of the On-X valve and compared to competing designs.


Joint Coordination to Facilitate the Transition From Sick Leave to Employment

GESAM is a randomized controlled intervention study that addressed women and men on long-term sick leave in Uppsala County. Participants which are on sick leave due to mental illness and/or pain and were expected to reach the time limit within the in health insurance will be offered to participate in an intervention. Those how give informed consent will be randomly assigned one of the following groups: 1) informing and motivating intervention with insurance officer 2) control ...

Reward Mechanisms in Obesity

The study aims to investigate the effects of 3.0 mg of liraglutide on reward brain circuits in human obesity and to better understand its effects on weight loss (in patients without diabetes). According to the study protocol, 70 obese patient will be evaluated at baseline and at 16-week (end of study) after daily subcutaneous injections of Saxenda® (liraglutide 3.0 mg) or Placebo by pen injector. All participants will first undergo a functional Magnetic Resonance Imagi...


Autologous Osteo-periosteal Cylinder Graft Transplantation for Hepple V Osteochondral Lesions of the Talus

The trial evaluates the clinical efficacy and safety of autologous osteo-periosteal cylinder graft transplantation for Hepple V osteochondral lesions of the talus. Half of participants will receive autologous osteo-periosteal cylinder graft transplantation, while the other will receive osteochondral graft transplantation as a control group.

Effects of the Administered Time of Meal on the Treatment of Overweight and Obesity

Objectives: To evaluate the impact of the meal time administered on the body weight of adult individuals of both sexes, being overweight and obese. Experimental design: randomized controlled trial. Place of research: Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil. Materials and methods: Anthropometric data, blood pressure, waist diameter will be measured; venous blood samples will be collected and stored for glucose, total cholesterol, triglycerides, HD...

Double-blind Placebo Surgery Trial for Treatment of Parkinson's Disease

A double-blind sham surgery-controlled trial was developed to determine the effectiveness of implantation of human embryonic dopamine neurons into the putamen of patients with advanced Parkinson's disease (PD), with half the patients receiving the implant (n = 20) and half receiving sham surgery (n = 20). The blind was maintained for 12 months before participants were told which surgery they received, at which time those receiving sham surgery could request the implant surgery.

Comparative Study of Survival and Long-term Quality of Life After Cardiac Surgery in Patients Who Are Jehovah's Witnesses

This is a comparative study on the survival and long-term quality of life of Jehovah's witnesses having undergone a cardiac surgery and having refused blood transfusions for religious reasons. This group will be compared with two other groups having no restrictions on this subject. The purpose of the study is to evaluate the impact of this decision on survival and postoperative quality of life, in the long term.

Prevention Among Young People With Intellectual Disability

This study aims to evaluate an intervention using the Toolkit "Children - what does it involve?" and the "Real-Care-Baby" (RCB) simulator among students with intellectual disability (ID), using a cluster randomized trial design with waiting-list control group.

Enhanced Treadmill Gait Training With Lower Limb Support After Stroke

This series of single case studies aims to test the feasibility and acceptability of an enhanced treadmill system for the recovery of gait function in stroke survivors. Forty adult participants who have had a stroke in the past year that resulted in impaired gait function and are attending a local hospital for gait training, will be recruited. Participants will be asked to attend a rehabilitation clinic for seven weeks, three times a week where they will receive enhanced treadm...

Using Gum Arabic for Cancer Patients to Protect From Oral Mucositis Caused by Chemotherapy: ِِِAn Experimental Study

This study was designed to investigate the effect of Gum Arabic (GA) on cancer patients to prevent chemotherapy-induced oral mucositis. Cancer patients who will receive chemotherapy were divided into two groups; study "Gum Arabic" group (which received GA with chemotherapy) and control group (chemotherapy alone); and the participants were recruited to reach 190 patients in the study group and 184 patients in control group. This clinical trial was conducted in outpatient chemoth...

Efficacy of Eat Breathe Thrive: A Randomized Control Trial of a Yoga-Based Program

The purpose of this study is to evaluate the efficacy of the 7-week Eat Breathe Thrive (EBT) program which was designed to increase positive body image, awareness, self-regulation, and mindful eating habits. This program aims to achieve these things through psychoeducation of cultural influences of beauty standards, the basic neuropsychological systems in the body and how they affect eating habits, creating a community within the group members for support, and finally through t...

Impact of [11C]-Methionine PET/MRI in the Detection of Pituitary Adenomas Secreting ACTH and Causing Cushing's Disease

Cushing's disease is characterized by the existence of a benign pituitary tumor developed from corticotropic cells responsible for excessive ACTH secretion. This results in hypercorticism causing high morbidity and mortality and severely impairing quality of life. The etiological diagnosis is based on Magnetic Resonance Imaging (MRI). However, pituitary MRI revealed a pituitary tumor in only 60% of patients. The diagnostic procedure is complicated by the existence of extra pitu...

Effects of a Yoga-Based Course in Preventing Disordered Eating in Female Collegiate Athletes

The purpose of this study is to evaluate effects of a 7-week undergraduate course, incorporating Eat Breathe Thrive program curriculum, offered to female student-athletes in order to increase positive body image, emotional regulation, interoceptive awareness, self-care skills, and intuitive eating. The undergraduate course is structured around the Eat Breathe Thrive program curriculum, which aims to: a) teach somatic practices that increase interoceptive awareness, b) provide h...

PD1-PIK Cell Therapy for Patients With Glioblastoma Multiforme

At present, we constructed a transgenic modified T cells, namely pluripotent immune killer (PIK) cells, the cells can stablely express a high-level full-length PD1 antibody , transduce signals to activate T cells, which results in tumor killing. This pilot study is to determine the safety and efficacy of autologous T cells in patients with recurrent glioblastoma.

Thrombin Generation During Cardiopulmonary Bypass With Titrated Versus Conventional Anticoagulation Management.

In this study, the investigators will be comparing anticoagulation for Cardiopulmonary Bypass (CPB) guided by the Hemostasis Management System (HMS Plus) with the current dosing based on weight and ACT measurements. The primary objective of this study is to determine whether relative to patients with conventional management, those managed with the HMS Plus have improved thrombin generation after CPB. The secondary objective is to determine if patients in the HMS Plus gr...

A Study Comparing 1 Subcutaneous Dose Regimen of Fremanezumab Versus Placebo for the Prevention of PPTH

This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of fremanezumab in adult patients aged 18 to 70 years, inclusive, for the prevention of PPTH. Patients will provide written informed consent and during study visits they will use an electronic diary application daily, to report their headache status and other health information. Efficacy and immunogenicity status will be captured periodically an...

Characterization of Arrhythmia Substrate to Ablate Persistent Atrial Fibrillation

A multicentre, parallel group, two arm, single-blinded randomized clinical trial, assessing the efficacy of a patient-tailored catheter ablation (CA) strategy guided by atrial scar mapping in addition to pulmonary vein isolation (PVI) when compared to PVI alone in patients with persistent atrial fibrillation (AF).

[18F]-F13640 as a New Brain Radiopharmaceutical

This clinical assay is designed to validate that [18F]F13640 as a radiotracer of 5-HT1A functional receptors. A first group of healthy subjects underwent a PET scan with arterial blood sampling to determine the kinetic model of the tracer. A second group of healthy subjects underwent a classical test-retest study (i.e two distant PET scans) to determine the reproducibility of measures.

Phase 3 Study to Evaluate the Efficacy & Safety of Tezepelumab in Adults & Adolescents With Severe Uncontrolled Asthma.

A Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents with Severe Uncontrolled Asthma

A Study to Assess the Efficacy and Safety of BIVV009 in Participants With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion (Cardinal Study)

The purpose of Part A is to determine whether BIVV009 administration results in a greater than or equal to (>=) 2 gram per deciliter (g/dL) increase in hemoglobin (Hgb) levels or increases Hgb to >= 12 g/dL and obviates the need for blood transfusion during treatment in participants with primary cold agglutinin disease (CAgD) who have a recent history of blood transfusion.The purpose of Part B is to evaluate the long-term safety and tolerability of BIVV009 in participants with ...

Clinical Trial With Riluzole in Spinocerebellar Ataxia Type 2 (ATRIL)

ATRIL is a multi-centric, double-blind randomized, two-arm controlled study. 42 SpinoCerebellar Ataxia type 2 (SCA2) patients, both gender, at least 18 years of age will be included. Riluzole 50 mg will be administered (per os) twice a day, versus one group with placebo for 12 months. Riluzole (Rilutek®) is a benzothiazole drug, market approved, for Amyotrophic Lateral Sclerosis (ALS). It delays the onset of ventilator-dependence or tracheostomy in selected patie...

A Study to Assess the Efficacy and Safety of BIVV009 in Participants With Primary Cold Agglutinin Disease Without A Recent History of Blood Transfusion (Cadenza Study)

The purpose of Part A is to determine whether BIVV009 administration results in a greater than or equal to (>=)1.5 gram per deciliter (g/dL) increase in hemoglobin (Hgb) level and avoidance of transfusion in participants with primary cold agglutinin disease (CAgD) without a recent history of blood transfusion. The purpose of Part B is to evaluate the long-term safety and tolerability of BIVV009 in participants with primary CAgD.

Deep Brain Stimulation of the Bilateral Habeluna for Treatment- Resistant Major Depression

Several open-label trials have shown the therapeutic promise of deep brain stimulation (DBS) in treatment-resistant depression (TRD). However, the results of placebo-controlled trials have been mixed. Here the investigators will explore whether active DBS in habeluna for TRD will result in better symptom improvement than sham DBS. This study will also use structural and functional MRI to identify the brain network changes between pre-operative, post operative active DBS ...

Effect of Body Position on Spirometry in Abdominal Obesity.

Objective: Study the effect of body position on spirometry in obese patients as defined by waist to hip ratio (WHR) of greater than 0.85 in women, and 0.9 in men Background: Spirometry is routinely ordered to work up dyspnea in obesity. The most common abnormality is a restrictive disease pattern. The underlying mechanisms of this pattern are not completely understood. One plausible explanation is diaphragmatic weakness or skeletal muscle weakness. The change in forced vital c...

MRI of Esophagus Cancer

The role of MRI in the management of esophageal cancer remains unclear and poorly studied. Recent technical advances suggest that MRI may become a powerful technique for the initial assessment of esophageal cancer, but also for the evaluation of response to neo-adjuvant treatment before surgery. This imaging study will be performed prospectively and consecutively in 60 patients included over a 18-month period in patients wîth newly diagnosed esophageal cancer. The aim ...


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