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NCT ID: NCT04507308 Completed - Sleep Disturbance Clinical Trials

Real-time Experiences With Sleep Training Study

REST
Start date: November 17, 2020
Phase: N/A
Study type: Interventional

Borderline personality disorder (BPD) is a serious mental illness that often first emerges in adolescence. Effective treatments are typically expensive, lengthy, and intense (e.g., Dialectical Behavior Therapy). Thus, setting individuals up for treatment success is extremely important. Disrupted sleep is closely linked to many BPD symptoms (e.g., moodiness, impulsivity, interpersonal problems), and people with BPD have a range of sleep-related problems. Importantly, sleep problems may make BPD symptoms worse, longer lasting, and also interfere with learning new skills in treatment. Understanding sleep problems in BPD may help create better interventions, as most therapies for BPD do not currently address sleep difficulties. Although approaches like Cognitive Behaviour Therapy for insomnia (CBT-I) and the Youth version of the Transdiagnostic Sleep and Circadian Intervention (TranS-C-Youth) work well with many populations, scientists don't yet know if youth with BPD features can tolerate a sleep-focused intervention. The investigators will recruit youth between ages 13 and 18 who have 3 or more clinically impairing BPD symptoms from the London community and via clinician referrals. They will also recruit a parent to report on their child's sleep patterns, mental health symptoms, and accompany youth to an intervention session. Participants will complete diagnostic interviews and a range of surveys to assess their current functioning (e.g., sleep, mental health, BPD symptoms). Investigators will also ask youth to report on their BPD symptoms multiple times per day in real time and track their sleep at night for a 10-day period. Participants will also wear a headband to track their brain waves while they sleep. After an initial 10-day monitoring period, youth participants will receive a brief, single-session sleep intervention with their parent using materials from the TranS-C-Youth protocol. Adolescents will be asked to follow a sleep plan created during their visit for three weeks before completing another 10 days of assessment. Participants will complete a follow-up survey battery upon completion of the second real-time survey protocol, and also be invited to complete surveys one-month post intervention. The investigators hypothesize that day-to-day variability in sleep will influence BPD symptom presentation, and vice versa. They also hypothesize that our intervention will improve sleep quantity/quality among an at-risk sample, and may be associated with decreased BPD symptoms relative to baseline.

NCT ID: NCT04504916 Completed - Pancreatic Cancer Clinical Trials

A Study of Zilovertamab Vedotin (MK-2140) (VLS-101) in Participants With Solid Tumors (MK-2140-002)

Start date: October 7, 2020
Phase: Phase 2
Study type: Interventional

This is a study evaluating the efficacy, safety, and pharmacokinetics of zilovertamab vedotin in participants with metastatic solid tumors including previously treated cancers of triple-negative breast cancer (TNBC), non-TNBC HER2-negative breast cancer, non-squamous non-small-cell lung cancer (NSCLC), gastric cancer, pancreatic cancer, and platinum-resistant ovarian cancer. The study will evaluate a null hypothesis that the objective response rate (ORR) is ≤5% against the alternative hypothesis that it is ≥20%.

NCT ID: NCT04504383 Completed - Clinical trials for Ulcerative Colitis Chronic Moderate

PN-943 in Adults With Moderate to Severe Active Ulcerative Colitis (UC)

Start date: August 5, 2020
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the safety, tolerability, and clinical efficacy of PN-943 450 mg twice daily [BID] and PN-943 150 mg BID, compared with placebo BID, in subjects with moderate to severe active Ulcerative Colitis (UC).

NCT ID: NCT04504175 Completed - Clinical trials for Treatment Resistant Depression

Ketamine for Older Adults Pilot

Start date: October 22, 2020
Phase: Phase 4
Study type: Interventional

This pilot study will assess the safety and feasibility of intravenous (IV) ketamine in older adults with Treatment-Resistant Depression (TRD). In addition, this study will develop and utilize innovative methodological approaches to demonstrate the feasibility of precision medicine and mobile health approaches in depression treatment.

NCT ID: NCT04504097 Completed - HIV Infections Clinical Trials

Tushirikiane HIV-self Testing Intervention With Urban Refugee Youth in Kampala, Uganda

Tushirikiane
Start date: November 13, 2019
Phase: N/A
Study type: Interventional

HIV is the leading cause of death for adolescents and young people (AYP) in sub-Saharan Africa (SSA). Uganda hosts 1.3 million refugees/displaced persons, and more than 80,000 live in Kampala, most in slums, yet little is known of HIV testing and prevention needs with displaced/refugee AYP living in Kampala's slums. This study aims to develop, implement and evaluate an oral HIV-self testing (HIVST) intervention with displaced/refugee AYP aged 16- 24 in Kampala. HIVST is acceptable and properly used with AYP in other SSA regions, yet there are knowledge gaps regarding the best way to link HIVST to HIV care. This study aims to explore how m-health (healthcare delivered on mobile-phones), congruent with how AYP learn and socialize, can improve linkage to care with HIVST. This trial focuses on implementing a cluster randomized trial with displaced/refugee AYP aged 16-24 living in informal settlements in Kampala (Arm1: HIVST; Arm 2: HIVST + m-health; Arm 3: standard of care). The study will assess changes in HIV testing practices, HIV status knowledge, and linkage to HIV prevention and care between the 3 arms.

NCT ID: NCT04502862 Completed - Asthma Clinical Trials

A Phase 4, Randomized, Double-blind, Placebo-controlled,Multicenter, Parallel-group Study of the Effect of Dupilumab on Sleep Disturbance in Patients With Uncontrolled Persistent Asthma

MORPHEO
Start date: August 10, 2020
Phase: Phase 4
Study type: Interventional

Primary Objective: To assess the effect of dupilumab on sleep Secondary Objectives: - To evaluate the effect of dupilumab on additional patient reported sleep outcomes - To evaluate the effect of dupilumab on objective sleep assessment - To evaluate the effect of dupilumab on asthma symptoms - To evaluate the effect of dupilumab on lung function - To evaluate the safety of dupilumab

NCT ID: NCT04502810 Completed - Vulvodynia Clinical Trials

High-level Laser for Provoked Vestibulodynia

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

This is a randomized feasibility and acceptability study investigating the effects of laser treatment in women suffering from provoked vestibulodynia compared to a sham-laser treatment. Participants will be randomized into the laser group or sham-laser group. The laser group will receive 12 sessions of real high-level laser therapy (HILT) (30-minutes biweekly for 6 consecutive weeks). The sham-laser group will receive 12 sessions (30-minutes biweekly for 6 consecutive weeks) of laser therapy using a deactivated probe. Outcomes measures will be assessed at baseline and at post-treatment and will include: feasibility and acceptability variables, pain, sexual function, sexual distress, psychological variables and perceived improvement after the treatment.

NCT ID: NCT04502693 Completed - Clinical trials for Infections, Meningococcal

Effectiveness of GlaxoSmithKline Biologicals S.A's Meningococcal Group B and Combined ABCWY Vaccines in Healthy Adolescents and Young Adults

Start date: August 14, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the effectiveness of 2 doses or 3 doses of GSK's licenced meningococcal group B Bexsero (rMenB+OMV NZ) vaccine and of 2 doses of GSK's investigational combined meningococcal (MenABCWY) vaccine (GSK3536819A) in healthy adolescents and young adults. The immunogenicity and safety were evaluated in the study.

NCT ID: NCT04501679 Completed - Prurigo Nodularis Clinical Trials

A Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN)

Start date: August 11, 2020
Phase: Phase 3
Study type: Interventional

The primary objective is to assess the efficacy of nemolizumab (CD14152) compared to placebo in participants greater than or equal to (>=) 18 years of age with prurigo nodularis (PN) after a 16-week treatment period.

NCT ID: NCT04501666 Completed - Prurigo Nodularis Clinical Trials

An Efficacy and Safety Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis

Start date: September 11, 2020
Phase: Phase 3
Study type: Interventional

The primary objective is to assess the efficacy of nemolizumab (CD14152) compared to placebo in participants greater than or equal to (>=) 18 years of age with prurigo nodularis (PN) after a 16 week treatment period.