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NCT ID: NCT04636749 Recruiting - Clinical trials for Stress Urinary Incontinence

Erbium Vaginal Laser for the Treatment of Stress Urinary Incontinence

Start date: March 9, 2021
Phase: N/A
Study type: Interventional

Two arms of women who suffer from clinical stress urinary incontinence. Women will be divided randomly into two arms. One arm will be treated with vaginal Erbium laser and the second with Sham laser, three treatments each. Follow up will be done 6 and 12 months after the last treatment.

NCT ID: NCT04635904 Recruiting - Social Anxiety Clinical Trials

Imagery Rescripting and Imaginal Exposure for Social Anxiety: Mechanisms and Outcomes in an Analog Sample

Start date: April 19, 2021
Phase: N/A
Study type: Interventional

This study will recruit 100 participants who self-report high symptoms of social anxiety (Social phobia inventory >30). Participants will be randomly assigned to receive either one analog intervention of Imagery Rescripting (IR) or Imaginal Exposure. We will test the efficacy and mechanisms behind each interventions.

NCT ID: NCT04634552 Recruiting - Clinical trials for Hematological Malignancies

A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma

MonumenTAL-1
Start date: February 1, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of talquetamab in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose(s) (RP2Ds) (Part 3).

NCT ID: NCT04633369 Recruiting - Dietary Fibers Clinical Trials

The Role of the Microbiome in the Response to Dietary Fibers Intake During Intermediate Fasting

Start date: April 21, 2021
Phase: N/A
Study type: Interventional

Dietary fibers are generally not degraded by the endogenous digestive enzymes, but rather by the complex ensemble of microorganisms that reside in the human gut [1]. This ensemble, collectively known as the human gut microbiome, plays a key role in breaking down, fermenting, and ultimately converting such dietary fibers into a variety of beneficial metabolites, including most notably, short chain fatty acids (SCFA). These end products of fibers' fermentation affect host metabolism, immunity, and physiology, and have been implicated in multiple diseases including obesity, metabolic syndrome, diabetes, and cardiovascular diseases. Intermediate fasting, and in particular circadian intermediate fasting (i.e. 16 hours of fasting followed by 8 hours of allowed eating), has been shown to have positive associations with multiple health conditions as obesity, diabetes mellitus, cardiovascular disease, cancers, and neurologic disorders In this study, we will try to answer open questions utilizing the long fasting period during the day to investigate the isolated effect of dietary fiber consumption, uncovering the degradation effect, but not the bulking effect, on the microbiome and the host physiology, and in particular its glucose response.

NCT ID: NCT04627701 Recruiting - Clinical trials for Benign Prostatic Hyperplasia

Omega Study: Evaluation of the Safety and Efficacy of the Omega System for the Treatment of BPH

Start date: July 23, 2023
Phase: N/A
Study type: Interventional

The ProArc Medical Omega system is a prostatic reshaping device that is designed to treat Lower Urinary Tract Symptoms (LUTS) due to BPH. During the procedure an implant is delivered into the prostate tissue obstructing the urethra and restricting urine flow. The delivery system uses a static diathermy incision mechanism to make a circumferential incision in the tissue surrounding the prostatic urethra into which the Omega shaped permanent implant is placed. The implant expands the obstructed area, reducing the fluid obstruction through the prostatic urethra.

NCT ID: NCT04626934 Recruiting - Rehabilitation Clinical Trials

Cognitive Intervention and Rehabilitation Outcomes in Hip Fracture Patients

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

The objective of the present study is to assess whether specific cognitive intervention will influence rehabilitation outcomes of post-acute hip fracture patients.

NCT ID: NCT04625907 Recruiting - Rhabdomyosarcoma Clinical Trials

FaR-RMS: An Overarching Study for Children and Adults With Frontline and Relapsed RhabdoMyoSarcoma

FaR-RMS
Start date: September 17, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

FaR-RMS is an over-arching study for children and adults with newly diagnosed and relapsed rhabdomyosarcoma (RMS)

NCT ID: NCT04624230 Recruiting - Ulcerative Colitis Clinical Trials

Evaluation of Oral Tofacitinib in Children Aged 2 to 17 Years Old Suffering From Moderate to Severe Ulcerative Colitis

Start date: August 12, 2021
Phase: Phase 3
Study type: Interventional

This study, A3921210 is designed to evaluate the efficacy, safety and pharmacokinetics (PK) of tofacitinib in pediatric participants with moderately to severely active UC. In the US and EU, patients with prior TNFi failure or intolerance will be enrolled. Outside of the US or EU, patients having had inadequate response or intolerance to oral or IV corticosteroids or azathioprine or 6-mercaptopurine or TNFi will be enrolled. All eligible participants will initially receive open label tofacitinib at a dose expected to produce equivalent systemic exposure to that observed in adults receiving 5 mg BID with the option for individual dose increase to 10 mg BID adult dose equivalent if dose escalation criteria are met. The primary objective of this study is to evaluate the efficacy of tofacitinib based on remission in pediatric participants with moderately to severely active UC. The primary endpoint is remission by central read Mayo score following 44 weeks in the maintenance phase. Remission is defined by a Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. The study Design is an open-label Phase 3 study that includes a screening period of up to 4-weeks duration, an 8-week or 16-week induction phase, a 44-week maintenance phase, and a 24-month extension phase for pediatric participants with moderately to severely active UC. Participants will have a follow-up visit 4 weeks after the last dose of study intervention and a telephone contact 8 weeks later to assess for any adverse events (AEs)/serious adverse events (SAEs). The total maximum duration of this study will be up to 180 weeks.

NCT ID: NCT04624204 Recruiting - Clinical trials for Small Cell Lung Cancer

Placebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK 7339-013/KEYLYNK-013)

Start date: December 8, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare overall survival (OS) and progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR). Hypothesis (H1): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib is superior to concurrent chemoradiation therapy alone with respect to PFS per RECIST 1.1 by BICR. Hypothesis (H2): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab is superior to concurrent chemoradiation therapy alone with respect to PFS per RECIST 1.1 by BICR. Hypothesis (H3): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib is superior to concurrent chemoradiation therapy alone with respect to OS. Hypothesis (H4): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab is superior to concurrent chemoradiation therapy alone with respect to OS.

NCT ID: NCT04623541 Recruiting - Clinical trials for Small Lymphocytic Lymphoma

Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome

EPCORE™ CLL-1
Start date: November 25, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The study is a global, multi-center safety and efficacy trial of epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20). Epcoritamab will either be studied as: - Monotherapy, or - Combination therapy: - epcoritamab + venetoclax - epcoritamab + lenalidomide - epcoritamab + R-CHOP (i.e., rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine and prednisone). The study includes patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL)/small lymphocytic lymphoma (SLL) and patients with Richter's Syndrome (RS). Study participants with R/R CLL/SLL are treated either with epcoritamab as monotherapy or epcoritamab + venetoclax. Study participants with RS are treated either with epcoritamab as monotherapy or epcoritamab + lenalidomide or epcoritamab + R-CHOP. The trial consists of two parts, a dose-escalation phase (phase Ib) and an expansion phase (phase II). Patients with RS are only included in the expansion phase.