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NCT ID: NCT03947554 Completed - Clinical trials for Psychological Stress

Ginseng HRG80 in Stress and Fatigue

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

This study evaluates the effects of a specific herbal preparation of Panax ginseng in preventing symptoms of stress in healthy individuals.

NCT ID: NCT03738761 Completed - Hypertension Clinical Trials

Management of Newly Diagnosed and Uncontrolled Hypertension With Fixed-Dose Combination of Perindopril/Amlodipine and Perindopril/Indapamide/Amlodipine

PRECIOUS
Start date: February 13, 2018
Phase: Phase 4
Study type: Interventional

PRECIOUS Study aims to evaluate the efficacy and safety of therapy with fixed-dose combination (FDC) of perindopril/amlodipine (Amlessa®) and FDC of perindopril/indapamide/amlodipine (Co-Amlessa®) on blood pressure reduction in both previously untreated patients and patients with previous antihypertensive therapy. Adult patients with AH who are treatment-naïve with systolic blood pressure (SBP) from 150 mmHg or higher AND/OR diastolic blood pressure (DBP) from 95 mmHg or higher (SBP ≥ 150 mm AND/OR DBP ≥ 90 mmHg for patients with type 2 diabetes mellitus ) and uncontrolled patients on mono, dual or triple antihypertensive therapy with systolic blood pressure (SBP) from 140 mmHg or higher AND/OR diastolic blood pressure (DBP) from 90 mmHg or higher (SBP ≥ 140 AND/OR DBP ≥ 85 mmHg for patients with type 2 diabetes mellitus) will be invited to participate in this study. During 16-week trial, seven study visits are planned. At first study visit physical examination, medical history, BP measurement, electrocardiogram (ECG), laboratory analysis and of Ambulatory Blood Pressure Measurement (ABPM) will be performed. Based on their previous antihypertensive therapy, patients will receive to treatment with either Amlessa® or Co-Amlessa® for the duration of 16 weeks and blood pressure measurements, laboratory investigations and patient interviews will be performed at study follow-up visits to assess the treatment efficacy (proportion of patients reaching normal office blood pressure after 16 weeks of treatment) and safety.

NCT ID: NCT03447912 Completed - Smoking Clinical Trials

Smoke-free Air Coalitions in Georgia and Armenia

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

This is a matched-pairs community randomized controlled trial (CRCT) to examine the impact of coalitions promoting smoke-free air policies on individual secondhand smoke exposure (SHSe). This proposal will build the capacity of Georgia (GE) and Armenia (AM) researchers to conduct high-quality mixed methods tobacco research and test the Community Coalition Action Theory (CCAT) as a framework for impacting local community-driven policy change to inform such processes for the region more broadly. Researchers from the GE National Center for Disease Control (NCDC) and AM National Institute of Health (NIH) will collaborate with Emory to execute the proposed research, train tobacco control researchers within their organizations and partnering universities, and train practitioners within local communities to build local coalitions for tobacco control policy. Twenty-eight communities (14 per country) will participate in the population-level tobacco survey at baseline and follow-up. Within each country, 7 communities will be randomized to the intervention condition and 7 to the control condition (14 communities per condition). In the intervention communities, public health center staff will form a coalition by recruiting partner organizations from civil society and other government sectors (e.g., health care, education), conduct situational assessment, and develop and implement action plans to promote the adoption and enforcement of smoke-free policies primarily in indoor and outdoor public places (e.g., worksites, hospitality). The GE NCDC and AM NIH will establish subcontracts with the local public health centers in the randomly selected communities to provide funding for local staff to develop local coalitions and to support program activities. The 14 communities assigned as controls will participate in the population-level survey and be provided with a site-specific summary of findings but will not participate in any aspects of the intervention. Additionally, to examine potential contamination in the control communities, a follow-up interview will be conducted with public health center leaders to assess any local coalition or grassroots actions regarding tobacco control that may have naturally occurred or be influenced by coalition activity in other communities.

NCT ID: NCT03407651 Completed - Clinical trials for Hemophilia A With Inhibitor

Study of Coagulation Factor VIIa Variant Marzeptacog Alfa (Activated) in Adult Subjects With Hemophilia A and B

Start date: December 18, 2017
Phase: Phase 2
Study type: Interventional

Phase 2, multi-center, open-label study designed to evaluate the PK, bioavailability, PD, efficacy and safety of a daily subcutaneous [SC] treatment regimen with MarzAA for bleeding prophylaxis in 12 adult subjects with hemophilia A or B with an inhibitor and history of frequent spontaneous bleeding episodes.

NCT ID: NCT03344458 Completed - Clinical trials for Endocrine System Diseases

A Long-Term Trial Investigating Safety and Efficacy of TransCon hGH in Children With Growth Hormone Deficiency Who Have Completed a Prior TransCon hGH Clinical Trial

enliGHten
Start date: December 19, 2017
Phase: Phase 3
Study type: Interventional

A multicenter, phase 3, long-term extension trial of TransCon hGH administered once-weekly in children with growth hormone deficiency (GHD) who previously participated in a phase 3 TransCon hGH trial. Approximately 300 children (males and females) with GHD will be included. All study participants will receive TransCon hGH. This is a global trial that will be conducted in, but not limited to, the United States, Poland, Bulgaria, Ukraine, Armenia, Russia and Australia.

NCT ID: NCT03259269 Completed - Clinical trials for Tuberculosis, Multidrug-Resistant

Expand New Drugs for TB [endTB]

Start date: April 1, 2015
Phase:
Study type: Observational

This observational study will examine the safety and efficacy of bedaquiline and delamanid used (individually, not together) in routine, multidrug regimens for treatment of MDR-TB. The information gathered in this study will inform doctors how best to use these TB drugs in the future.

NCT ID: NCT03255785 Completed - Clinical trials for Glaucoma, Open-Angle

Open-Angle Glaucoma Subjects With Cataract Treated With Cataract Surgery Plus One iStent and One iStent Supra

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

Open Angle Glaucoma Subjects with Cataract treated with Cataract Surgery plus one trabecular micro-bypass stent and one suprachoroidal stent

NCT ID: NCT03072992 Completed - Clinical trials for Metastatic Breast Cancer

"Curcumin" in Combination With Chemotherapy in Advanced Breast Cancer

Start date: March 20, 2017
Phase: Phase 2
Study type: Interventional

The aim of this study is to assess benefits of treatment with intravenous Curcumin® (CUC-01) vs placebo, in combination with paclitaxel chemotherapy, and to estimate the risk of adverse events in patients with locally advanced and metastatic breast cancer. This is a randomized, double-blind, placebo-controlled, two arms parallel group phase 2 clinical trial: Group A, 75 patients, treatment with Curcumin (CUC-01, yellow solution), 300mg i.v. plus i.v. Paclitaxel (colorless solution) 80 mg /m2 BS i.e., once weekly for 12 weeks. Group B, 75 patients, treatment with Paclitaxel (colorless solution) 80 mg /m2 BS, i.v. plus placebo i.v. solution (250 ml, yellow solution for masking/blinding), once weekly for 12 weeks. Primary objective of the study: To assess: - Efficacy of combined therapy with Curcumin ®, (CUC-01) and Paclitaxel vs Paclitaxel in patients with advanced and metastatic breast cancer in terms of Objective Response Rate (ORR) assessed with the Modified Response Evaluation Criteria In Solid Tumours (RECIST). Secondary objectives of the study: To assess: - The safety of Curcumin+Paclitaxel combination compared to Paclitaxel+placebo treatment by assessment of adverse effects. - Quality of life (QOL) in patient treated with Curcumin+Paclitaxel combination compared to Paclitaxel+Placebo - Response duration in terms of Progression free survival (PFS), Time to Disease Progression (TTP) and Time to treatment failure (TTTF)

NCT ID: NCT03029728 Completed - Clinical trials for Hereditary Angioedema

Biomarker for Hereditary AngioEdema Disease

BioHAE
Start date: August 20, 2018
Phase:
Study type: Observational

International, multicenter, observational, longitudinal monitoring study to identify, validate and/or monitor Mass Spectrometry (MS)-based biomarker/s for Hereditary Angioedeme (HAE) disease and to test the clinical robustness, specificity, and predictive value of theese biomarker/s

NCT ID: NCT03014193 Completed - Medical Abortion Clinical Trials

Simplifying First Trimester Medical Abortion Follow-up

Start date: January 2017
Phase: N/A
Study type: Observational

This study evaluates the usability of the multilevel pregnancy test among women undergoing medical abortion.