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NCT ID: NCT04195620 Terminated - Clinical trials for Cardiovascular Diseases

Loneliness and Social Connection in Cardiovascular Disease

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

The study evaluates the impact of vulnerable self-disclosure and perceived responsiveness in individuals across levels of loneliness. Participants will be randomized to a high disclosure or a low disclosure condition.

NCT ID: NCT04194528 Terminated - Metastatic Cancer Clinical Trials

S1916 Digital Medicine Program for Pain Control in Cancer Patients

Start date: January 22, 2020
Phase: N/A
Study type: Interventional

This is a feasibility study to assess the use of a Digital Medicine Program (consisting of an FDA-approved ingestible sensor co-encapsulated with oxycodone/acetaminophen (5 mg/325 mg), a small wearable patch, and a mobile application) in cancer patients with metastatic disease experiencing uncontrolled pain.

NCT ID: NCT04193904 Terminated - Pancreatic Cancer Clinical Trials

A Study of Live Biotherapeutic Product MRx0518 With Hypofractionated Radiation Therapy in Resectable Pancreatic Cancer

Start date: December 20, 2019
Phase: Phase 1
Study type: Interventional

This is a single center, open-label, phase I study to evaluate the safety and preliminary efficacy of MRx0518 with preoperative hypofractionated radiation in 15 patients with resectable pancreatic cancer. Subjects will take MRx0518 daily for one week prior to the start of radiation therapy, throughout radiation and until surgical resection of the tumour.

NCT ID: NCT04193293 Terminated - Clinical trials for Head and Neck Squamous Cell Carcinoma

A Study of Duvelisib in Combination With Pembrolizumab in Head and Neck Cancer

Start date: June 1, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This study was designed to assess the safety and preliminary efficacy of duvelisib in combination with pembrolizumab in participants with recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).

NCT ID: NCT04192448 Terminated - Anger Clinical Trials

Men, Mood, and Attention Study: Examination of Alcohol, State Anger, and Emotion Regulation Sexual Aggression

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

Given the public health and social relevance of sexual aggression and the gap in the extant literature regarding state anger, emotion regulation, alcohol, and sexual aggression, the present study will contribute to our understanding of emotion regulation's role in sexual aggression perpetration. The proposed 2-year research plan will examine the effects of alcohol intoxication, state anger, and emotion regulation on men's sexual aggression intentions. This study will recruit non-monogamous, men (individuals who identify their gender as male and whose biological sex is male) who have sex with women, ages 21-35. While more research on female perpetrators is needed, the proposed study will exclusively recruit males for the following reasons: 1) the scientific literature indicating the majority of sexually aggressive acts are perpetrated by men; and 2) the current sexual aggression analog has not been piloted with female participants and would require preliminary experiments to determine its appropriateness. The study will utilize a 2x2 design in which participants are randomized to beverage condition [alcohol (target BAC= .08gm%) or control (no alcohol control)] and an emotion induction (anger induction or control). The outcomes will be assessed using a sexual aggression analog which participants will complete on the descending limb of alcohol intoxication and indicate the likelihood that they would engage in various sexually aggressive acts. The study also includes self-report measurements of state anger and emotion regulation to explore emotion regulation as a moderator in the associations among alcohol intoxication, state anger, and sexual aggression intentions.

NCT ID: NCT04192318 Terminated - Clinical trials for Violence in Adolescence

Evaluating Outcomes for Youth Receiving Hospital-based Violence Prevention With and Without a Community-level Initiative

Start date: February 10, 2020
Phase: N/A
Study type: Interventional

The purpose of this research study is to test if a hospital-based violence prevention strategy with a community-level initiative is effective for cross-cutting violence prevention in violently injured youth.

NCT ID: NCT04191733 Terminated - Clinical trials for Rheumatoid Arthritis

Anterior Advantage With KINCISE

Start date: January 28, 2020
Phase: N/A
Study type: Interventional

This is a post-market prospective, 1:1 randomized, multicenter non-inferiority study to compare the femoral broaching time for THA with the Anterior Advantage approach with KINCISE vs. without KINCISE. Follow-up will continue through 24 weeks post-op.

NCT ID: NCT04191382 Terminated - Breast Cancer Clinical Trials

Phase 2 Window Study of SAR439859 (Amcenestrant) Versus Letrozole in Post-menopausal Patients With ER+, HER2- Pre-operative Post-menopausal Primary Breast Cancer

AMEERA-4
Start date: February 4, 2020
Phase: Phase 2
Study type: Interventional

Primary Objective: To determine whether amcenestrant given at 2 different doses improved the antiproliferative activity when compared to letrozole. Secondary Objectives: - To assess the proportion of participants with a relative decrease from Baseline in percentage of positive tumor cells tested by immunohistochemistry greater than or equal to (>=) 50 percent (%) (Ki67 >=50%) in the three treatment arms. - To assess estrogen receptor (ER) degradation in biopsies in participants in the three treatment arms. - To assess safety in the three treatment arms.

NCT ID: NCT04191356 Terminated - Heart Failure Clinical Trials

Evaluating Mobile Health Tool Use for Capturing Patient-centered Outcomes Measures in HF Patients

Start date: October 17, 2020
Phase:
Study type: Observational

Heart Failure (HF) is a highly prevalent disease that also carries high morbidity and mortality. The Food and Drug Administration (FDA) recognizes the importance of developing patient-centric endpoints that are relevant to patients beyond mortality and hospitalizations. Although functional status can be objectively measured by peak exercise oxygen consumption, it is difficult and impractical to implement in large clinical studies, especially in an ambulatory real-world setting. Recently, new mobile health technologies have emerged as clinical tools and offer an opportunity to overcome these challenges in measuring functional capacity and recording symptoms. The goal of this observational study is to evaluate the feasibility of monitoring functional capacity among patients with heart failure (HF) using mobile health monitoring platforms. Everion® and Apple Watch Series 4 and above will be used for this study. The BiovitalsHF® mobile app can capture patients' key cardiopulmonary physiological parameters, functional capacity (using activity patterns, including guided mobile-based 6MWT, audio recording) and assessment of QoL through validated PROs.

NCT ID: NCT04191031 Terminated - Clinical trials for Post-Operative Pain Management

Study to Evaluate Iovera®° in Adult Patients Undergoing Total Knee Arthroplasty

Start date: September 30, 2020
Phase: N/A
Study type: Interventional

Primary objective: The primary objective of this study is to evaluate postsurgical pain control, after presurgical iovera° treatment plus EXPAREL® and standardized multimodal therapy compared with presurgical sham iovera° treatment plus EXPAREL and standardized multimodal therapy in subjects undergoing primary unilateral total knee arthroplasty (TKA). Secondary objectives: The secondary objectives of this study are to compare postsurgical pain control or postsurgical total opioid consumption, opioid-free status, physical function, sleep quality, and safety of presurgical iovera° treatment plus EXPAREL and standardized multimodal therapy with presurgical sham iovera° treatment plus EXPAREL and standardized multimodal therapy, in subjects undergoing primary unilateral TKA