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NCT ID: NCT03583658 Recruiting - Pharyngitis Clinical Trials

Efficacy and Safety Study of New Ambroxol Hardboiled Lozenges in Acute Pharyngitis

DELICIOUS
Start date: June 30, 2018
Phase: Phase 3
Study type: Interventional

Primary Objective: To assess the efficacy of the new hard boiled Ambroxol lozenges 20 mg for the relief of sore throat pain in patients with acute pharyngitis. Secondary Objective: To assess the safety of the new hard boiled Ambroxol lozenges 20 mg in patients with acute pharyngitis.

NCT ID: NCT03567421 Recruiting - Stone, Kidney Clinical Trials

Ureteral Stenting After Ureteroscopy for Stone Treatment, A Global Perspective on Indications and Outcomes

Start date: June 7, 2018
Phase:
Study type: Observational [Patient Registry]

Background: The exit strategy after ureteroscopy for stone treatment remains a topic for discussion. Current EAU guidelines on urolithiasis state that postoperative stenting is indicated in patients at increased risk of postoperative complications. Stenting is not considered necessary in all other cases, and after uncomplicated procedures. Objective: To analyse the postoperative ureteral stenting strategy in clinical practice looking at the indication, type of stents used and the duration of stenting after ureteroscopy for stone treatment. Furthermore, the investigators will examine in what setting the stents are being removed postoperatively. Study design: This study is a prospective, observational, international, multicentre registry study executed by uCARE. Study population: All patients >18 years with a ureter or renal stone who are planned for ureteroscopic treatment by semi-rigid and/or flexible ureteroscopy are eligible for this study.

NCT ID: NCT03552757 Recruiting - Obesity Clinical Trials

Research Study Investigating How Well Semaglutide Works in People With Type 2 Diabetes Suffering From Overweight or Obesity

STEP 2
Start date: June 4, 2018
Phase: Phase 3
Study type: Interventional

This study will look at the change in the participant's body weight from the start to the end of the study. This is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking "dummy" medicine. In addition to taking the study medicine, the participant will have talks with study staff about healthy food choices, how to be more physically active and what else the participant can do to lose weight. Overweight and obesity is associated with an increased risk of type 2 diabetes. Therefore, weight loss has shown to have a beneficial impact on the blood sugar levels. The participant will either get semaglutide or "dummy" medicine - which treatment the participant get is decided by chance. The participant will need to take 2 injections at the same time once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 1.5 years

NCT ID: NCT03548987 Recruiting - Obesity Clinical Trials

Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity

STEP 4
Start date: June 4, 2018
Phase: Phase 3
Study type: Interventional

This study will look at the change in participant's body weight from the start to the end of the study. This is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking "dummy" medicine. In addition to taking the medicine, the participant will have talks with study staff about healthy food choices, how to be more physically active and what a participant can do to lose weight. The participant will get semaglutide for the first 20 weeks. Then the participant will get either semaglutide or "dummy" medicine - which treatment the participant gets after the 20 weeks is decided by chance. The participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 1.5 years.

NCT ID: NCT03547583 Recruiting - Clinical trials for Chronic Heart Failure With Preserved Ejection Fraction

Patient-reported Outcomes in Vericiguat-treated Patients With HFpEF

VITALITY-HFpEF
Start date: June 15, 2018
Phase: Phase 2
Study type: Interventional

The primary hypothesis in this trial is that the treatment with vericiguat 10 mg or 15 mg in patients with HFpEF improves the KCCQ PLS (Kansas City Cardiomyopathy Questionnaire Physical limitation score) compared to placebo after 24 weeks of treatment.

NCT ID: NCT03540667 Recruiting - Clinical trials for Osteoarthritis, Knee

Study of Hip and Knee Arthroplasty in South Africa

Start date: May 7, 2018
Phase:
Study type: Observational

This multi-site, observational, prospective study aims to investigate current practice and associated outcomes for patients scheduled for elective unilateral total hip or knee arthroplasty in South Africa.This information will provide baseline values, against which effects of implementing a multidisciplinary enhanced care protocol for arthroplasty patients will be compared (the subsequent study).

NCT ID: NCT03529409 Not yet recruiting - Clinical trials for Human Immunodeficiency Virus

Effectiveness & Implementation of a Behavioral Intervention for Adherence and Substance Use in HIV Care in South Africa

Start date: July 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to test the effectiveness and implementation of a brief, integrated behavioral intervention for HIV medication adherence and substance use in the HIV care setting in South Africa. The intervention is specifically designed to be implemented by non-specialist counselors using a task sharing model in local HIV clinics. The behavioral intervention will be compared to usual care, enhanced with referral to a local outpatient substance use treatment program (Enhanced Standard of Care - ESOC) on study endpoints (as described in study endpoint section below).

NCT ID: NCT03519503 Recruiting - Clinical trials for Growth and Development

Infant Peri-Exposure Prophylaxis to Prevent HIV-1 Transmission by Breastfeeding: Mechanisms & Safety

Start date: February 27, 2017
Phase:
Study type: Observational

General objective - To assess the long-term safety and efficacy of one-year infant prophylaxis using lamivudine (3TC) or lopinavir/ritonavir (LPV/r) to prevent post-natal transmission through breastfeeding. - To investigate the biological mechanisms involved in postnatal HIV transmission. Specific objectives - To compare the long-term safety of infant prophylaxis using either 3TC versus LPV/r on child development (growth, somatic and mental health), mortality, adrenal function, liver function, full blood count and mitochondrial toxicity. - To estimate the final efficacy data of 50 weeks of infant prophylaxis using either LPV/r or 3TC, since some mothers may have resumed breastfeeding after the trial. - To profile miRNA in breast milk according to maternal HIV status and HIV transmission. - To determine the influence of maternal milk on infant gut inflammation in an in vitro 3D-intestinal model (CACO-2 cells). The study population will comprise all ANRS 12174 PROMISE-PEP trial participants who completed the 50 week follow-up and are not HIV infected. An estimate of 881 mother-child pairs from the ANRS 12174 PROMISE- PEP will be recruited. This study is structured in two parts. The 'clinical & biological safety' component involves a cross sectional survey. A clinical and neuropsychological examination of participants will be conducted. In addition one venous blood sample will be collected to evaluate children HIV status, full blood count, liver & adrenal function and mitochondrial toxicity. Capillary hair follicles will be collected from 100 children in Zambia to study their genome integrity. The 'mechanisms' component includes biological assays to be conducted on breast milk samples previously collected from HIV infected, transmitting or non-infected mothers enrolled at ANRS 12174 PROMISE-PEP trial. Primary endpoint: Long term survival, mortality rate, measurements of infant growth (length and weight), somatic and neuropsychological development of the 5 year old children enrolled in the ANRS 12174 PROMISE- PEP trial. Secondary endpoints: HIV seroconversion since last PROMISE PEP trial visit, full blood count, liver function, adrenal function, serum lactate. Number of mitochondrial DNA copies per cell & percentage of mitochondrial DNA deletion for mitochondrial toxicity. Number of micronuclei & number of Ɣ-tubulin spot per cell to study genomic toxicity.

NCT ID: NCT03517878 Active, not recruiting - HIV Infections Clinical Trials

Evaluation of a Home-based Community Health Worker Program in Rural Eastern Cape, South Africa

Start date: August 11, 2014
Phase:
Study type: Observational

The purpose of this early Phase 2 comparison trial is to evaluate the impact of community health worker (CHW) home visitors on pregnant women and their children in a rural setting in the rural Eastern Cape of South Africa. The intervention provided by the CHWs targets underweight children, mothers living with HIV (MLH), mothers using alcohol, and depressed mothers with the goal of supporting pregnant women to improve birth outcomes, decrease the number of children born with a low birthweight, and develop child caretaking skills over time. UCLA has identified and matched four areas surrounding primary health care clinics: two intervention areas in which this CHW program has been running for one year, and two control areas without the program. Mothers in the research area are followed for one year after giving birth.

NCT ID: NCT03517722 Recruiting - Clinical trials for Lupus Erythematosus, Systemic

A Study of Ustekinumab in Participants With Active Systemic Lupus Erythematosus

Start date: April 16, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of ustekinumab in participants with active systemic lupus erythematosus (SLE) who have not adequately responded to one or more standard of care treatments.