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NCT ID: NCT03310658 Active, not recruiting - Clinical trials for Total Laparoscopic Hysterectomy

Zip-Stitch™ for Vaginal Cuff Closure in Total Laparoscopic Hysterectomy

Start date: April 17, 2017
Phase: N/A
Study type: Interventional

ZSX Medical completed enrollment in its First in Human Ease of Use study in May of 2017, in Monterrey Mexico. The purpose of this study is to demonstrate the ease of use of Zip-Stitch™, to generate first in human data, and to refine surgical technique of the device. Ten subjects were enrolled and received total laparoscopic hysterectomies, including vaginal cuff closure with the Zip-Stitch™ system during their otherwise standard care. Procedures took place over the course of one week. Subjects had in person follow-up appointments at 1 and 6 weeks. Subjects are continuing follow-up through a one-year extension period which will end in May 2018.

NCT ID: NCT03308409 Recruiting - Clinical trials for Erectile Dysfunction

Comparative Effectiveness and Safety of Three Protocols Usin Li-ESWT for Erectile Dysfunction

Start date: August 1, 2017
Phase: N/A
Study type: Interventional

The patients with primary erectile dysfunction (IIEF-EF <26 points), will be randomly assigned to three shockwave treatment protocols: Protocol 1 six sessions, one per week; Protocol 2, six initial sessions, one per week, followed by monthly maintenance sessions (every 4 weeks) for five months; Protocol 3, six monthly sessions. The EHS and IIEF-EF scores will be compared as well as the possible adverse events from the therapy upon beginning and completing the treatment and at the 3-month and 6-month follow-ups. Self-esteem and quality of life will also be evaluated using the SEAR scale.

NCT ID: NCT03304496 Recruiting - Clinical trials for Coronary Artery Disease

Subcutaneous Nitroglycerin to Facilitate Trans-radial Access.

NITRAD-Sub
Start date: March 30, 2017
Phase: Phase 4
Study type: Interventional

Femoral artery approach to perform coronary procedures is considered the standard technique for vascular access due to optimal catheter control, lower thromboembolic complications and immediate access due to the large diameter of the artery. Trans-radial approach has been shown to reduce major bleeding complications, vascular complications related to the site of puncture, including death from all causes, and to prevent post-procedure limb rest, greater comfort for patients, immediate ambulation, early discharge and reduction of costs. Previous studies have shown that intravenous, topical and intraarterial use of nitroglycerin produces vasodilation of the radial artery. Extravascular (subcutaneous) administration of nitroglycerin is extremely effective in restoring the radial pulse, and allows adequate cannulation.

NCT ID: NCT03303001 Recruiting - Clinical trials for Subacromial Impingement Syndrome

Comparison Between Subacromial Infiltrations

Start date: September 26, 2017
Phase: N/A
Study type: Interventional

The shoulder pain is commonly seeing in orthopedic consultation. Many patients was affected in activities of daily living and in laborer absent. One of the first treatment lines is the steroid infiltration for pain relieve, however in several times is only effective by a short period of time, and the symptoms usually appear again. One of the not known infiltration is the high volumen infiltration in subacromial space, this treatment appears to be an effective treatment for this patients.

NCT ID: NCT03302234 Not yet recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

Study of Pembrolizumab Given With Ipilimumab or Placebo in Participants With Untreated Metastatic Non-small Cell Lung Cancer (MK-3475-598/KEYNOTE-598)

Start date: November 24, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the efficacy of pembrolizumab given in combination with either ipilimumab or placebo as first-line treatment in participants with metastatic non-small cell lung cancer (NSCLC). The primary hypothesis of this study is that overall survival (OS) and/or progression-free survival (PFS) is prolonged in participants who receive pembrolizumab and ipilimumab compared to those who receive pembrolizumab and placebo.

NCT ID: NCT03301220 Recruiting - Clinical trials for Smoldering Multiple Myeloma

A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma

Start date: November 7, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to determine whether treatment with daratumumab administered subcutaneously (SC) prolongs progression-free survival (PFS) compared with active monitoring in participants with high-risk smoldering multiple myeloma (SMM).

NCT ID: NCT03296553 Recruiting - Clinical trials for Human Immunodeficiency Virus

Valganciclovir Four Weeks Prior to cART Initiation Compared to Standard Therapy for Disseminated Kaposi Sarcoma

Start date: October 1, 2015
Phase: Phase 2
Study type: Interventional

Kaposi sarcoma (KS) has an unpredictable course, patients with severe KS and low CD4 counts (<100 cells) can develop Immune Reconstitution Syndrome (IRIS) after the initiation of combined Antiretroviral Therapy (cART). The objective of this study is to evaluate the presence of IRIS and its attributable mortality in patients with HIV and severe KS with the use of Ganciclovir or the prodrug Valganciclovir prior to the initiation of cART compared with the standard management of immediate cART initiation.

NCT ID: NCT03296163 Not yet recruiting - Clinical trials for Non-small Cell Lung Cancer

A Study Comparing MB02 and Avastin® in Subjects With Stage IIIB/IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

STELLA
Start date: December 2017
Phase: Phase 3
Study type: Interventional

This is a multicenter, multinational, double-blind, 1:1 randomized, parallel-group, equivalence Phase 3 study to compare the efficacy and safety of MB02 plus chemotherapy (carboplatin and paclitaxel) versus Avastin® plus chemotherapy (carboplatin and paclitaxel) in subjects with Stage IIIB/IV non-squamous NSCLC

NCT ID: NCT03294265 Enrolling by invitation - Clinical trials for Type 2 Diabetes Mellitus

A Peer Support Program to Enhance Treatment Adherence in Patients With Type 2 DM

Start date: August 1, 2016
Phase: N/A
Study type: Interventional

Diabetes Mellitus (DM) affects patients' quality of life in different dimensions. Therefore, it is considered a priority to design and create specialized intervention programs in order to prevent and decrease complications. The peer support program studies have shown to Increase adherence to treatment and the proportion of patients with adequate long-term metabolic control. The benefits that these programs bring are the social and emotional support in the daily management of the disease through shared experiences and communication in a continuous way. There are only a few peer support programs in Mexico, thus it is required to investigate the effects of their implementation in our environment to promote empowerment and maintain long-term lifestyle changes. The present study has the objective to enhance self-care behaviors and health empowerment in patients with diabetes through peer support.

NCT ID: NCT03293875 Recruiting - Risk Behavior Clinical Trials

Adaptation and Implementation of Project Encuentro in the U.S.-Mexico Border

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

The proposed project is a research collaboration between the University of Texas at El Paso, The Alliance for Border Collaboratives and Programa Companeros to adapt, implement, and evaluate a multi-level community-based HIV prevention intervention (Project Encuentro). The intervention will target active heroin and crack users and consists of increasing access to HIV testing via a social network HIV testing component and reducing sexual and drug use risk via a peer network brief behavioral Intervention. Encuentro also consists of conducting community awareness meeting to target structural factors affecting HIV risk. The intervention was developed in an area severely affected by violence and stigma towards drug users, El Salvador, which makes it particularly suitable for adaptation to meet the needs of drug users living in the proposed intervention site, the U.S.-Mexico border. The proposed intervention site also has been severely affected by violence which has curtailed any prior attempts to reduce the risk drug users' HIV risk. Violence has worsened structural factors which affect HIV risk such as, increasing police persecution and stigma and reducing access to resources. In our proposed project, we will engage in formative research to understand the context of HIV risk of drug users in the border region post violence and adapt the intervention accordingly. Findings will allow the investigators to tailor intervention components to meet the needs of drug users in the region. Subsequently, the investigators propose to test intervention effectiveness and evaluate implementation barriers and facilitators. To accomplish project aims we will use a mixed qualitative, quantitative approach. The investigators will begin with a formative phase by conducting in-depth interviews with drug users (n = 40) living in the region to understand how the context of drug use risk changed as a result of the violence and will administer a social network survey (n = 200) to characterize the configuration of risk networks. Findings will yield the necessary information to culturally adapt the intervention to meet the needs of drug users in the region and will help the investigators focus recruitment efforts where the riskiest networks are located. After the intervention is adapted with the help of the community advisory boards and the community coalitions, the investigators will implement the intervention and will assess the effectiveness and reach via 6 cross-sectional surveys administered to drug users (n=1,200). The investigators will assess the process of implementation by conducting ethnographic field notes of all intervention activities including community engagement and Community Advisory Board and coalition meetings. The investigators will assess the fidelity and quality of the intervention. Lastly, the investigators will conduct key informant interviews with key stakeholders involved in the project and interviews and observations will be coded to reflect key systems factors related to successful implementation of intervention components in two intervention sites (El Paso, Texas and Ciudad Juarez, Mexico). Findings will be highly significant as the investigators will be conducting parallel research on the effectiveness of interventions shown to be effective in Latino drug users in two very different contexts: El Salvador and the U.S-Mexico border. Findings will elucidate implementation challenges and barriers and such information can then be used to assess the effectiveness of diverse implementation strategies in organizations working to serve the needs of Latino drug users.