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NCT ID: NCT03356067 Recruiting - Gastroparesis Clinical Trials

Endoscopic Pyloromyotomy for Refractory Gastroparesis

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

Gastroparesis is a disorder triggered by numerous causes and it is defined by symptoms and with an objective evidence of delayed gastric emptying in the absence of obstruction. Effective treatment for gastroparesis is challenging especially in patients with severe symptoms. In refractory gastroparesis, endoscopic or surgical treatments may therefore be considered. Endoscopic treatments include intrapyloric injection of botulinum toxin and transpyloric insertion of a metallic stent. Surgical options involve implantation of a gastric "pacemaker" (gastric stimulation), pyloroplasty and subtotal gastrectomy. Recently, a new endoscopic technique, gastric endoscopic per oral pyloromyotomy (G-POEM) has been introduced with promising preliminary results. The aim of this prospective, sham-controlled, cross-over study (cross-over for patients randomized to the sham arm) is to compare short and long-term efficacy and safety of G-POEM in patients with refractory gastroparesis. Symptoms and objective parameters of gastric emptying will be the main outcome criteria. The reason of using a sham protocol is to control for the potential confounders (therapeutic effects of touch and belief, which are components of the placebo effect).

NCT ID: NCT03354429 Not yet recruiting - Clinical trials for Acute Ischaemic Stroke

THALES - Acute STroke or Transient IscHaemic Attack Treated With TicAgreLor and ASA for PrEvention of Stroke and Death

THALES
Start date: January 31, 2018
Phase: Phase 3
Study type: Interventional

Study to investigate if the study drug ticagrelor and ASA is more effective than Placebo (inactive tablet) and ASA in preventing new stroke events.

NCT ID: NCT03333317 Not yet recruiting - Clinical trials for Respiratory Syncytial Viruses

A Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine (JNJ-64041575) Regimens in Hospitalized Infants and Children Aged 28 Days to 36 Months Infected With Respiratory Syncytial Virus

Start date: November 16, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine in hospitalized infants and children who are infected with respiratory syncytial virus (RSV) the dose-response relationship of multiple regimens of lumicitabine on antiviral activity based on nasal RSV shedding using quantitative real-time reverse transcriptase polymerase chain reaction (qRT-PCR).

NCT ID: NCT03332459 Not yet recruiting - Clinical trials for Respiratory Syncytial Virus Infections

A Long-term Follow-up Study to Evaluate the Impact of Lumicitabine on the Incidence of Asthma and/or Wheezing in Infants and Children With a History of Respiratory Syncytial Virus Infection

Start date: January 5, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this long-term follow-up (LTFU) study is to evaluate the incidence of the clinical diagnosis of asthma and the frequency of wheezing in infants and children with respiratory syncytial virus (RSV) infection who were treated with (lumicitabine or placebo) and have completed their last planned study‑related visit in a feeding Phase 2 study (64041575RSV2004).

NCT ID: NCT03330470 Recruiting - Healthy Volunteers Clinical Trials

Molecular Mediators of Physical Exercise and Carnosine Induced Effects in Patients With Preclinical and Early Stage Neurodegenerative Disease

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

The purpose of this study is to investigate the beneficial effects of regular exercise and the impact of food supplement carnosine on cognitive, motoric and metabolic functions as well as on specific biologically active substances in volunteers with subjective (SCI) or mild (MCI) cognitive impairment, as well as in patients in early stages of Parkinson's disease. The investigators assume the immediate intervention-associated health benefit for volunteers.

NCT ID: NCT03306394 Recruiting - Clinical trials for Metastatic Colorectal Cancer

An Early Access Study of Trifluridine / Tipiracil (S 95005/TAS-102) in Patients With a Pretreated Metastatic Colorectal Cancer

Start date: October 18, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to collect additional safety and efficacy data during treatment with trifluridine / tipiracil in patients with a pretreated metastatic colorectal cancer (mCRC). Eligible patients may receive an early access to trifluridine / tipiracil through this clinical study until progression of disease, unacceptable toxicity, investigator decision, patient refusal or until market authorization or reimbursement has been granted by the relevant Authority of the country where that patient is treated or until trifluridine / tipiracil is available by a doctor's prescription or can be accessed from another source or Sponsor decision.

NCT ID: NCT03290781 Not yet recruiting - Ulcerative Colitis Clinical Trials

Study of the Effect of SHP647 as Maintenance Treatment in Participants With Moderate to Severe Ulcerative Colitis Who Achieved Clinical Response in Induction Studies

FIGARO UC 303
Start date: February 22, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of SHP647 as maintenance therapy in participants with moderate to severe ulcerative colitis (UC) who achieved clinical response in induction studies. This is a phase 3, randomized, double-blind, placebo-controlled, parallel-group efficacy and safety study.

NCT ID: NCT03283085 Not yet recruiting - Ulcerative Colitis Clinical Trials

A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects With Moderate to Severe Ulcerative Colitis (AIDA)

Start date: January 22, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of long-term treatment with SHP647 in participants with moderate to severe Ulcerative Colitis (UC).

NCT ID: NCT03282682 Recruiting - Physical Activity Clinical Trials

Strength Training as a Supplemental Therapy of Androgen Deficiency of the Aging Male

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

This study examines the effect of 12-week strength training program with and without testosterone replacement therapy (TRT) on body composition, physical function, selected biochemical markers of metabolic health, molecular parameters of training adaptation and the quality of life patients with ADAM. The investigators believe, that strength training program performed 2 times per week for 12 weeks can improve body composition (decrease fat mass and gain lean mass), muscle strength, muscle power and general quality of life in all training groups. In addition, combination TRT and strength training could help decrease fat mass, improve BMI, cardio-respiratory fitness and thus provide optimal therapy combination for hypogonadal ageing males.

NCT ID: NCT03268005 Recruiting - Diabetes Clinical Trials

Research Study Comparing a New Medicine "Fast-acting Insulin Aspart" to Another Already Available Medicine "NovoRapid"/"NovoLog" in People With Type 2 Diabetes

onset 9
Start date: September 19, 2017
Phase: Phase 3
Study type: Interventional

The study compares 2 medicines for type 2 diabetes: fast-acting insulin aspart (a new medicine) and NovoRapid®/NovoLog® (a medicine doctors can already prescribe). Fast-acting insulin aspart will be tested to see how well it works and if it is safe. Participants will get either fast-acting insulin aspart or NovoRapid®/ NovoLog® - which treatment you get is decided by chance. Both medicines will be taken together with insulin degludec. Participants will need to take 1 injection 4 times every day (all insulins will be provided in pens). The study will last for about 8 months (34 weeks).