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NCT ID: NCT04173949 Recruiting - Clinical trials for Persistent Developmental Stuttering

Explorative Study for Treating Persistent Developmental Stuttering With Ramipril

Start date: March 15, 2020
Phase: Phase 3
Study type: Interventional

Persistent developmental stuttering (PDS) is diagnosed when developmental stuttering persists beyond adolescence. Most stutterers experience vast improvement in stuttering during childhood and it generally disappears within five years. A minority of stutterers continue stuttering over age 18, often accompanied by social and personal difficulties. Following a report of a 75 year old woman, with severe Persistent developmental stuttering , who experienced significant improvement in her stuttering since treated by Ramipril for hypertension, we scrutinized the literature, and discovered that there is a physiological basis for this surprising reaction. Ace inhibitors, such as Ramipril, might in fact be successful for treating Persistent developmental stuttering . In theory, it seems that ACE inhibitors, such as Ramipril could improve stuttering by reducing striatum dopamine levels. 1. Stuttering is associated with high striatum dopamine levels 2. Angiotensin receptors are present in the striatum 3. Angiotensin causes elevated striatum dopamine levels 4. ACE inhibitors penetrate the blood brain barrier and reduce brain angiotensin II levels. Methods The study will begin as a pilot study in which 10 stuttering patients will be recruited for 12 weeks on open label Ramipril 1.25mg/d. If there is improvement in at least 2 of the stuttering patients, we will continue to the main study. Efficacy Evaluation: 1. The MINI Neuropsychiatric interview will be used to rule out major neuropsychiatric conditions 2. Stuttering evaluation 1. Stuttering Severity instrument Version 4 (SSI-4) (Riley 2009) 2. SLD :Percentage of stuttered syllables (Yairi 2015) 3. The Subjective Screening of Stuttering (SSS) 4. Speech Situation Checklist (Brutten 1975,1981) 3. Leibowitz Social Anxiety Scale (Leibowitz 1987) The efficacy evaluation will be performed by speech therapists. All evaluations will be will be recorded on video Safety evaluation: 1. Blood pressure: The average of three consecutive measures. Blood pressure will be measure in both arms on the first meeting, and thereafter on the arm with the highest measurements. 2. Orthostatic hypotension will be defined as a drop of 20mmHg systolic or 10mmHg diastolic, one and three minutes after standing from sitting position. 3. Creatinine clearance will be calculated by the MDRD method (Levy 2006) GFR, in mL/min per 1.73 m2 = 186.3 x SCr (exp[-1.154]) x Age (exp[-0.203]) x (0.742 if female) x (1.21 if black)

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: NCT04173091 Recruiting - Clinical trials for Functional Tricuspid Regurgitation

Risk Stratification in Severe Treatment-naive, Tricuspid Regurgitation

TRuE
Start date: January 1, 2013
Phase:
Study type: Observational [Patient Registry]

This registry is aimed to characterize patients with severe tricuspid regurgitation for the purpose of patient selection for interventional treatment and identify factors related to adverse outcomes.

NCT ID: NCT04167358 Recruiting - Cholestasis Clinical Trials

Linerixibat Long-term Safety, and Tolerability Study

LLSAT
Start date: July 14, 2020
Phase: Phase 3
Study type: Interventional

This is an open-label, non-comparator, global, multi-center, long-term safety study for evaluating safety and tolerability of linerixibat in participants with cholestatic pruritus in primary biliary cholangitis (PBC) who participated in a prior clinical trial with linerixibat (BAT117123 [NCT01899703], 201000 GLIMMER [NCT02966834] (group 1) or 212620 GLISTEN [NCT00210418]) (group 2). All participants will receive open-label linerixibat for the duration of the study. The study duration is expected to last until the study's end or until linerixibat can be lawfully made available to participants. However, the total duration of study participation will vary by participant depending upon the time of entry relative to study end in their respective country.

NCT ID: NCT04167059 Recruiting - Rett Syndrome Clinical Trials

Telehealth Support to Increase Physical Activity in Rett Syndrome

ActivRett
Start date: January 1, 2020
Phase: N/A
Study type: Interventional

This study will recruit families with a daughter with Rett syndrome living in either Australia, Denmark or Israel, and thereafter deliver individually designed participation programs using telehealth strategies. We will evaluate the effectiveness of the programs on reducing sedentary behaviours, increasing physical activity and increasing quality of life.

NCT ID: NCT04165798 Recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Advanced Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)

Start date: December 19, 2019
Phase:
Study type: Observational

This study is referred to as the "umbrella master protocol" for pembrolizumab (MK-3475) in the treatment of non-small cell lung cancer (NSCLC). This pembrolizumab NSCLC umbrella master protocol uses a platform design and consists of this master screening study and three substudies. Each substudy will enroll a different population of NSCLC participants. The goal of this umbrella master protocol is to screen potential participants with NSCLC for enrollment into 1 of 4 substudies. Participants must first enroll in this pembrolizumab master protocol study and undergo screening for NSCLC that will be used to assign them to participation in 1 of 4 pembrolizumab substudies.

NCT ID: NCT04160221 Recruiting - Clinical trials for Medical Abortion, Complete or Unspecified, Without Complication

Second Trimester Medical Abortion

RAPM
Start date: November 1, 2019
Phase: N/A
Study type: Interventional

The use of Mifepristone, an antiprogesterone, and Misoprostol together, has been shown to make the medial abortion process more efficient and reduce the induction-to-abortion interval by almost 50%. Despite the recommended 24-48 Mifepristone-Misoprostol interval, recent retrospective study of a flexible interval, have revealed shorter total abortion time with shorter intervals. In this study we aim to compare 24 to 12 hours Mifepristone to Misoprostol intervals

NCT ID: NCT04158765 Recruiting - Male Infertility Clinical Trials

The Impact of Lifestyle on Sperm Telomere Length and Telomerase Activity in Men Undergoing IVF Treatments

Start date: November 20, 2019
Phase:
Study type: Observational

This aim of this study is to determine the impact of lifestyle on telomere length and telomerase enzyme activity on sperm cells of men undergoing IVF treatments.

NCT ID: NCT04157218 Recruiting - Clinical trials for Skin Lifting and Tightening

Thread Lifting and Microfocused Ultrasound for Face Tightening Ultrasound for Lifting and Tightening the Face

Start date: November 15, 2019
Phase: N/A
Study type: Interventional

Skin aging is a continuous and inevitable presses usually starting at the age of mid-twenties, this prosses affects all facial layers including skin, subcutaneous fat, superficial muscular aponeurotic system (SMAS), deep facia, the retaining ligaments, muscle activity, and even facial bony structure . The clinical outcome of this process causes the aging signs of the face and neck, including loose facial skin, sagging cheeks, excess skin hanging from the lower jawline and excess fat in the neck . In the last decade with the introduction of absorbable threads, thread lifting has gained interest and popularity among patients and physicians, as noninvasive technique to treat ptotic skin and reposition of ptotic soft tissue into a more anatomical direction. Histopathological studies indicated that dermal and subcutaneous foreign body reaction after inserting the threads, in forms of collagen deposition, and fibrosis , could explain the tightening effect throughout contracture and remodeling. However, some studies question efficacy especially in the aspects of durability and patient satisfaction . Another nonsurgical alternative for facial rejuvenation is high-intensity focused ultrasound (HIFU) therapy, during the past decade, HIFU has been used as a clinical noninvasive surgical tool to treat tumors, including those of the liver, prostate, and uterus (10-12) The HIFU devices heat tissue with acoustic energy in a focused, controlled manner. The thermal injury within the tissue leads to focal necrosis and cellular damage, initiating an inflammatory cascade that culminates in tissue remodeling, similar to changes that occur after ablative or nonablative laser treatments . The Investigators hypothesis that the HIFU treatment followed immediately by thread insertion can amplify and enhance the skin fibrosis, tissue lifting capacity and might give better and longer clinical results in treating ptotic skin.

NCT ID: NCT04154969 Recruiting - Stroke Clinical Trials

The Effect of Vestibulo-ocular Reflex Improving Exercise on Gait and Balance Among Post Stroke Sub Acute Patients

Start date: November 10, 2019
Phase: N/A
Study type: Interventional

This study evaluate the effect of Vestibular rehabilitation program as part of physical therapy during rehabilitation post stroke. half of participants will receive vestibular exercise as part of the physiotherpy session, while the other half will receive a conservative physiotherapy session.