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NCT ID: NCT03720002 Completed - Ulcerative Colitis Clinical Trials

HF2 Therapy in the Treatment of Active Ulcerative Colitis

Start date: May 29, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase I-II study with the herbal formulation (HF2) for treatment of active ulcerative colitis This will be a two-stage study: Stage 1 will comprise an open label single arm exploratory study of 10 active ulcerative colitis (UC) patients investigating oral HF2 therapy for induction of remission in outpatients with active UC. Active disease is defined as (SCCAI) score ≥5 and a score of ≥2 in the modified Mayo endoscopic sub-score. Clinical remission is defined as a SCCAI score of ≤2 The patients will receive HF2 therapy for 4 weeks. Stage 2: If clinical response (defined as a drop of ≥3 points of the SCCAI score ) is achieved in ≥ 3 patients and no significant safety signals will emerge, the investigators will proceed to a prospective pilot randomized placebo-controlled study. Patients will be randomized into one of two arms: HF2 once daily or placebo formulation (2:1 proportion) for 8 weeks. The primary outcome for stage 2 is a co-primary outcome of clinical response (reduction in SCCAI of ≤3 OR achievement of clinical remission defined as SCCAI ≤2) coupled with an objective evidence of response (Mayo score improvement of ≥1 or 50% FcAL reduction) at week 8. Patients clinically responding at week 8, will be eligible to continue in an 8-weeks extension study to receive either placebo or 1.5gr/day curcumin alone until week 16, as per their original allocation. Exploratory analysis of outcomes for the extension study will include the percentage of patients in clinical remission (SCCAI≤2) and the percentage of patients who maintained clinical response (reduction in SCCAI of ≥3 point compared to week 0).

NCT ID: NCT03719313 Completed - Clinical trials for Hepatitis Delta Virus

Study of the Efficacy and Safety of Lonafarnib / Ritonavir With and Without Pegylated Interferon -Alfa-2a

D-LIVR
Start date: December 1, 2018
Phase: Phase 3
Study type: Interventional

Two LNF-containing regimens will be evaluated in the D-LIVR Phase 3 study: (1) LNF/RTV/PEG IFN-alfa-2a and (2) LNF/RTV. Each of these arms will have efficacy endpoints that measure clinical benefit with regard to viral suppression and alanine aminotransferase (ALT) normalization. For each LNF-containing regimen, a composite endpoint of EOT (48 weeks) virologic response and ALT normalization will be used. Virologic response will be defined as a 2 log10 IU/mL reduction from baseline.

NCT ID: NCT03717675 Completed - Coronary Occlusion Clinical Trials

Supplemental Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter

Start date: October 1, 2018
Phase: N/A
Study type: Interventional

This study will include up to 60 eligible male and female subjects. The purpose of this trial is to evaluate the safety and effectiveness of the NovaCross™ micro-catheter when used to facilitate crossing of Chronic Total Occlusion (CTO) lesions in coronary arteries. The procedure will be conducted on consenting patients diagnosed with a CTO in a coronary vessel that requires revascularization after a previously failed attempt to cross or refractory to 10 minutes of conventional guidewire attempt. This study is an extension study of Nitiloop's Pivotal study.

NCT ID: NCT03714126 Completed - Heart Failure Clinical Trials

Remote Speech Analysis in HF Patients Undergoing Haemodialysis

Start date: March 27, 2019
Phase:
Study type: Observational

This is an observational, non-interventional, prospective, single-arm, open study for database establishment for R&D purposes. The study will be conducted in 1 site in Israel with up to fifty (50) patients. Patients under hemodialysis supervision will be enrolled in the clinical trial. Clinical information for the study will be collected at the hospital and at home. The patient will conduct recordings at home every day.

NCT ID: NCT03713632 Completed - Clinical trials for Hidradenitis Suppurativa

Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS)

SUNRISE
Start date: February 25, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study was to demonstrate superiority of secukinumab at Week 16, based on Hidradenitis Suppurativa Clinical Response (HiSCR) rates versus placebo, along with the maintenance of efficacy of secukinumab at Week 52 in subjects with moderate to severe HS. Moreover, this study assessed the safety and tolerability of secukinumab.

NCT ID: NCT03713619 Completed - Clinical trials for Hidradenitis Suppurativa

This is a Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS).

SUNSHINE
Start date: January 31, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate superiority of secukinumab at Week 16, based on Hidradenitis Suppurativa Clinical Response (HiSCR) rates versus placebo, along with the maintenance of efficacy of secukinumab at Week 52 in subjects with moderate to severe HS. Moreover, this study will also assess the safety and tolerability of secukinumab.

NCT ID: NCT03712228 Completed - Clinical trials for Hereditary Angioedema

A Study to Investigate CSL312 in Subjects With Hereditary Angioedema (HAE)

Start date: October 29, 2018
Phase: Phase 2
Study type: Interventional

This is a multicenter, randomized, placebo-controlled, parallel-arm, phase 2 study to investigate the clinical efficacy, pharmacokinetics, and safety of CSL312 as prophylaxis to prevent attacks in subjects with HAE.

NCT ID: NCT03709615 Completed - Clinical trials for Social Anxiety Disorder

Therapeutic Processes in iCBT for SAD

Start date: December 20, 2017
Phase: N/A
Study type: Interventional

The current study examines therapeutic processes during internet-based cognitive-behavioral therapy for social anxiety disorder. Participants will be randomized to either treatment or wait-list conditions. Participants in the wait-list condition will receive active treatment following the wait-list period.

NCT ID: NCT03708939 Completed - Glucose Intolerance Clinical Trials

Microbiome and Non-caloric Sweeteners in Humans

Start date: February 19, 2017
Phase: N/A
Study type: Interventional

Non-caloric sweeteners are common food supplements consumed by millions worldwide as means of combating weight gain and diabetes, by retaining sweet taste without increasing caloric intake. While they are considered safe, there is increasing debate regarding their potential role in contributing to metabolic derangements in some humans. The investigators recently demonstrated that non-caloric sweeteners consumption could induce glucose intolerance in mice and, in preliminary experiments, in distinct human subsets, by functionally altering the gut microbiome, and that the gut microbiome plays an important role in mediating differential glucose responses to identical foods. The proportion of the human population that is susceptible to glucose intolerance induced by non-caloric sweeteners, the common factors that are shared between these individuals and whether and how the microbiome promotes the metabolic derangements remain to be addressed.

NCT ID: NCT03707223 Completed - Disabilities Mental Clinical Trials

Effectiveness of Interfaces Program to Promote Work Ability of People With Disabilities

Start date: September 2016
Phase: N/A
Study type: Interventional

the objectives of the study is to Evaluate the effectiveness of "The Interfaces Program" to promote person's components, performance and improving the work environment of people with disabilities.