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NCT ID: NCT04200521 Recruiting - Obesity Clinical Trials

The Effect of Bariatric Procedures on Gut Microbiota in Obese Individuals in United Arab Emirates and Lebanon

Start date: October 27, 2019
Phase:
Study type: Observational [Patient Registry]

Overweight and obesity are worldwide health problems that can affect negatively quality of life. With increasing prevalence of obesity and the failure of compliance to lifestyle, bariatric surgeries have become the treatment of choice to help achieve long term sustainable weight loss. In some cases of bariatric surgery, weight loss stops and there are cases in which obesity manifests itself again; the mechanism underlying the re-appearance of obesity is not known. Recently, the gut microbiota, has been implicated in the etiology of obesity and metabolic syndrome due to its important role in digestion, metabolism and regulating gut peptides and hormones. In accordance with this, it has been shown in mice that obesity can be associated with dysbiosis (Imbalance in gut bacteria) and there has been successful reduction of weight in interventions when microbiota was manipulated. Hypothesis: 1. Emirati participants will have unique microbiota and gut peptides when compared to Lebanese participants. 2. The microbiota and gut peptides variability is significantly different between those with normal weight compared to obese participants undergoing bariatric surgery. 3. The bariatric procedure will have a significant effect on the variability of microbiota, gut peptides, blood chemistry, dietary intake and metabolism among the obese participants. Objectives of the study: 1. Determine the gut microbiota composition of Emirati healthy normal weight participants and compare to that of Lebanese via Illumina sequencing NGS (Next Generation Sequencing of the 16S rRNA gene) of the microbiota from the stool samples. 2. Determine the gut microbiota composition of Emirati obese participants and compare to that of Lebanese counterparts using NGS. 3. Determine the effect of bariatric procedure in UAE and Lebanon respectively on gut microbiota (using NGS), gut peptides in plasma, blood chemistry and metabolism using indirect calorimetry and food intake. Importance of this research: The microbiota and gut peptides variability is determined by body weight and ethnicity of the studied populations. It is hypothesized that bariatric surgery will have a significant effect on the variability of microbiota, gut peptides, blood chemistry, dietary intake and metabolism. This study will be a pioneering research in UAE and Lebanon to assist in finding population tailored therapeutic strategies that target the gut microbiota and treat obesity.

NCT ID: NCT04194424 Recruiting - Obesity Clinical Trials

A Multidisciplinary Weight Loss Program at AUB-MC

Start date: June 17, 2019
Phase: N/A
Study type: Interventional

The current project aims at evaluating the feasibility and efficacy of a multi-disciplinary weight loss program, using an innovative and simple dietary intervention at the American University of Beirut Medical Center (AUB-MC). Such intervention is expected to enhance patients' compliance and adherence to lifestyle changes. In addition, the program includes supervised exercise sessions and behavioral therapy. Therefore, our project proposes an evidence based approach to close the obesity treatment gaps.

NCT ID: NCT04188509 Recruiting - Sickle Cell Disease Clinical Trials

Open-Label Extension of Voxelotor

Start date: November 18, 2019
Phase: Phase 3
Study type: Interventional

Open-label extension study of voxelotor for participants with Sickle Cell Disease who have participated in voxelotor clinical trials.

NCT ID: NCT04184089 Recruiting - Clinical trials for High-flow Nasal Cannula

High Flow Nasal Cannula in Patients Undergoing ERCP Retrograde Cholangiopancreatography With Intravenous Sedation.

Start date: August 25, 2020
Phase: N/A
Study type: Interventional

The goal of this randomized clinical trial is to identify the optimal flow rate during high flow nasal cannula therapy that will prevent airway obstruction and its associated desaturation and maintain saturation greater than 95% in patients undergoing ERCP procedure under intravenous deep sedation. This study aims to identify the optimal flow rate during high flow nasal cannula therapy that will prevent airway obstruction and its associated desaturation and maintain saturation greater than 95% in patients undergoing ERCP procedure under intravenous deep sedation. Participants will be randomized to 3 groups: G0 will receive a 5 l/ min flow rate through a nasal cannula at and FiO2 of 40 %, G1 will receive a 15 l/ min flow rate and FiO2 of 40% and G2: will receive a 60L/min flow rate and FiO2 of 40%. Researchers will compare intraprocedural factors to find out the optimal nasal cannula flow rate for maintenance of safe IV deep sedation in endoscopic retrograde cholangiopancreatography (ERCP) patients and to assess gastroenterologist and patient satisfaction.

NCT ID: NCT04173273 Recruiting - Crohn's Disease Clinical Trials

A Study Evaluating the Efficacy and Safety of Oral Etrasimod in the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease

CULTIVATE
Start date: January 6, 2020
Phase: Phase 3
Study type: Interventional

This is a Phase 2/3 study that comprises 5 substudies designed to evaluate the efficacy, safety, and tolerability of oral etrasimod as therapy in adult participants with moderately to severely active Crohn's disease (CD) who are refractory or intolerant to at least 1 of the current therapies for CD (ie, corticosteroids, immunosuppressants, or biologics). The overall duration of this study is up to 282 weeks, inclusive of the Screening Period, Treatment Period of up to 274 weeks (Induction, Extension or Maintenance, and Long-term Extension Periods), and the 4-Week Follow-Up Period for safety assessment.

NCT ID: NCT04153032 Recruiting - Anal Fissure Clinical Trials

Comparative Evaluation of MEBO Ointment and Topical Diltiazem Ointment in the Treatment of Acute Anal Fissure

MEBO
Start date: December 1, 2019
Phase: Phase 2
Study type: Interventional

No study to date has compared topical DTZ to MEBO ointment in the treatment of anal fissure. Therefore, the present study aims to compare the efficacy and safety of DTZ to MEBO in the treatment of acute anal fissure. The investigators propose to conduct a comparative randomized clinical study. In this study, the investigators will compare patients with acute anal fissure receiving MEBO ointment vs Topical DTZ ointment vs a combination of MEBO and DTZ ointment. Hypothesis: MEBO in combination with DTZ is more effective than DTZ or MEBO alone in the treatment of acute anal fissure.

NCT ID: NCT04143724 Recruiting - Beta-Thalassemia Clinical Trials

Study of Safety & PK of Luspatercept (ACE-536) in Pediatric Participants With Beta (β)-Thalassemia

Start date: November 7, 2019
Phase: Phase 2
Study type: Interventional

This is a Phase 2a study to evaluate the safety and pharmacokinetics (PK) of luspatercept in pediatric participants with β-thalassemia. The study will be conducted in 2 parts for both transfusion-dependent (TD) and non-transfusion-dependent (NTD) β-thalassemia participants: TD Part A will be in adolescent participants aged 12 to <18 years with two dose escalation cohorts, followed by a dose expansion cohort. NTD Part A will be conducted in the same age group participants as TD Part A with dose confirmation and expansion phase. After Part A TD participants have completed at least one year of treatment, all available safety data from Part A adolescent participants will be evaluated before initiating TD and NTD Part B in the age group from 6 to <12 years old. Part B will consist of two dose escalation cohorts for TD and two dose escalation cohorts for NTD. Upon completion of the Treatment Period, participants of any cohort who are benefiting from the study treatment, will be offered the opportunity to continue luspatercept treatment in the Long-term Treatment Period for up to 5 years from their first dose. Participants who discontinue study treatment at any time will continue in the Posttreatment Follow-up Period for at least 5 years from their first dose of luspatercept, or 3 years from their last dose, whichever occurs later, or until they withdraw consent/assent, are lost to follow-up, or the End of Trial, whichever occurs first.

NCT ID: NCT04096768 Recruiting - Sedation Clinical Trials

The Use of Ketamine and Dexmedetomidine in Intensive Care Sedation

Start date: September 16, 2019
Phase: Phase 3
Study type: Interventional

The aim of the study is to compare the use of dexmedetomidine + ketamine with dexmedetomidine + placebo for sedation in ICU patients in terms of safety and efficacy

NCT ID: NCT04096339 Recruiting - Clinical trials for Anesthesia, Recovery

Reduction in Sedation: Colonoscopy vs Esophagoduodenoscopy First

RECoVER
Start date: July 3, 2019
Phase: N/A
Study type: Interventional

The purpose of this research is to compare the effect of different procedural sequences on the time to recovery and the propofol sedation requirements in patients undergoing bidirectional endoscopy with sedation. The two sequences are: - Colonoscopy followed by Esophagogastroduodenoscopy (EGD) - EGD followed by Colonoscopy

NCT ID: NCT04064060 Recruiting - Beta-thalassemia Clinical Trials

A Study to Evaluate Long-term Safety in Participants Who Have Participated in Other Luspatercept (ACE-536) Clinical Trials

Start date: August 12, 2019
Phase: Phase 3
Study type: Interventional

A Phase 3b, open-label, single-arm, rollover study to evaluate the long-term safety of luspatercept, to the following participants: - Participants receiving luspatercept on a parent protocol at the time of their transition to the rollover study, who tolerate the protocol-prescribed regimen in the parent trial and, in the opinion of the investigator, may derive clinical benefit from continuing treatment with luspatercept - Participants in the follow-up phase previously treated with luspatercept or placebo in the parent protocol will continue into long-term post-treatment follow-up in the rollover study until the follow-up commitments are met - The study design is divided into the Transition Phase, Treatment Phase and Follow-up Phase. Participants will enter transition phase and depending on their background will enter either the treatment phase or the Long-term Post-treatment Follow-up (LTPTFU) phase - Transition Phase is defined as one Enrollment visit - Treatment Phase: For participants in luspatercept treatment the dose and schedule of luspatercept in this study will be the same as the last dose and schedule in the parent luspatercept study. This does not apply to participants that are in long-term follow-up from the parent protocol - Follow-up Phase includes: - 42 Day Safety Follow-up Visit - During the Safety Follow up, the participants will be followed for 42 days after the last dose of luspatercept, for the assessment of safety-related parameters and adverse event (AE) reporting - Long-term Post-treatment Follow-up (LTPTFU) Phase - Participants will be followed for overall survival every 6 months for at least 5 years from first dose of luspatercept in the parent protocol, or 3 years of post-treatment from last dose, whichever occurs later, or until death, withdrawal of consent, study termination, or until a subject is lost to follow-up. Participants will also be monitored for progression to AML or any malignancies/pre-malignancies. New anticancer or disease related therapies should be collected at the same time schedule Participants transitioning from a parent luspatercept study in post-treatment follow-up (safety or LTPTFU) will continue from the same equivalent point in this rollover study. The rollover study will be terminated, and relevant participants will discontinue from the study when all participants fulfill at least 5 years from the first dose of luspatercept in the parent protocol, or 3 years of post-treatment from last dose, whichever occurs later.