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NCT ID: NCT01641549 Not yet recruiting - Clinical trials for Left-sided Prosthetic Heart Valve Thrombosis

Surgery Versus Fibrinolytic Therapy for Left-sided Prosthetic Heart Valve Thrombosis

SAFE-PVT
Start date: April 2017
Phase: Phase 3
Study type: Interventional

Malfunction of mechanical heart valves due to clot formation is a potentially devastating complication. It often results in heart failure, death or stroke. This condition occurs frequently in patients with mechanical valves in developing countries because they are unable to monitor and adjust the dose of blood thinning medications. The best treatment modality for the treatment of patients with this condition is not known. There is no reliable data from clinical trials to guide treatment and there are no firm guidelines. Treatment with clot-busting drugs is most commonly used because these drugs (e.g., streptokinase) are readily available, cheap, and easy to use. However, this treatment is associated with high rates of treatment-related side-effects (death, life-threatening bleeding and stroke). Moreover, some recent studies suggest that clot-busting drugs may not be as efficacious in restoring valve function, as previously believed. Emergency surgery is less often used because it is more expensive and the required facilities and manpower are not available at all times at all places. But there is evidence to suggest that surgery results in better success rates with a lower risk of bleeding and stroke. Well-designed prospective randomised trials (the "gold-standard" for reliable evidence) comparing the efficacy, safety and cost-effectiveness of the two modalities, are needed to help doctors in developing countries make informed decisions when treating patients with clotted mechanical heart valves. The investigators propose to perform a randomised controlled trial comparing emergency surgery with treatment with clot-busting agents in patients with clotted mechanical valves. The study will be conducted over 4 years at a single, university hospital in a developing country. This study will determine how often patients who are treated with surgery will be discharged from hospital, with completely restored valve function, without having suffered a stroke or life-threatening bleeding, when compared to those who received clot-busting drugs. The investigators will also find out which of the treatments is safe and cost-effective.

NCT ID: NCT02383537 Not yet recruiting - Diabetes Clinical Trials

Biological Changes in the Adipose Tissue Among Pregnant Women With Diabetes

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

The aim of the research is to study the effect of miRNA, fat tissue and insulin resistance on the pathophysiology of diabetes during pregnancy. During the study fat tissue, Umbilical cord blood, placenta tissue and subcutaneous fat will be taken from pregnant diabetic woman over going a C-section. Healthy pregnant women will serve as a control group.

NCT ID: NCT02742376 Not yet recruiting - Clinical trials for Complex Regional Pain Syndrome

Comparison of Gait Parameters Between Floor and Sponge Surfaces and Special Shoes

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

This study compares the gait pattern of individuals with weight bearing difficulties walking on the floor, a soft surface, or with special shoes (Kyboot).

NCT ID: NCT02873000 Not yet recruiting - COPD Clinical Trials

Incentive Spirometry in Non-critically Ill Hospitalized Patients With Acute Respiratory Failure

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

To evaluate the use of Incentive Spirometry in Non-critically Ill Hospitalized Patients With Shortness of Breath.

NCT ID: NCT02884895 Not yet recruiting - Clinical trials for Adverse Anesthesia Outcome

A Comparison of Direct Laryngoscopy With Blind Intubation Via Intubating Laryngeal Tube Suction Disposable

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

Tracheal intubation is an important part of treatment for a trauma casualty. Tracheal intubation is usually achieved by a direct laryngoscope.It is an effective method but requires experience and skill demanding a long learning time.The use of the Laryngeal Tube Suction for fast control of the airway is known for many years. The Intubating Laryngeal Tube Suction is a new version of the Laryngeal Tube. The aim of this study is to examine the effectiveness of the the Intubating Laryngeal Tube Suction to achieve a definitive airway by unskilled practitioners in anesthetized patients with the head in neutral position (trauma model).

NCT ID: NCT02936661 Not yet recruiting - Clinical trials for Postpartum Hemorrhage, Cesarean Section

Tranexamic Acid for Preventing Postpartum Hemorrhage After Cesarean Section

Start date: April 2017
Phase: Phase 4
Study type: Interventional

It is a multicenter randomized, double-blind and placebo-controlled trial. Totally 6500 women to delivery by cesarean section will be recruited in this study. In addition to routinely oxytocin, the women in study group will receive TXA 1 g in 2 minutes after they delivered their babies, and those in control group will receive placebo. The incidence of postpartum hemorrhage, the amount of bleeding, as well as the side effects will be observed.

NCT ID: NCT02949882 Not yet recruiting - Constipation Clinical Trials

Improving Bowel Habits of Elderly With Probiotics and Non-probiotics

Start date: April 2017
Phase: Phase 4
Study type: Interventional

There is a relative high prevalence of constipation and antibiotic-associated diarrhoea (AAD) in the elderly residents of nursing homes, mainly due to high antibiotic and medication usage. Constipation and diarrhoea causes a substantial burden on lives of the frail elderly and significantly reduces the quality of life (QoL). In addition, these circumstances lead to a higher workload for healthcare workers and treatment of constipation and diarrhoea increase costs in healthcare. There are indications that the gastrointestinal microbiome is altered in conditions, such as constipation and AAD. Research indicates that probiotics show potential in the treatment of constipation, AAD and infectious diarrhoea. Probiotics can restore the aberrant gastrointestinal microbiome and thereby possibly treat/prevent constipation and diarrhoea in the frail elderly population. To illustrate, a previous pilot study of probiotic administration in elderly residents of a nursing home demonstrated a reduced prevalence of constipation and diarrhoea stool types and a higher prevalence of ideal stool types during the intervention compared to the baseline period. These promising results demand for a confirmatory study in this population.

NCT ID: NCT02961634 Not yet recruiting - Onychomycosis Clinical Trials

Study Efficacy and Safety in Comparative Use of Investigational Product Adjuvant Treatment in Onychomycosis

Start date: April 2017
Phase: Phase 3
Study type: Interventional

Single-center study, single blind, comparative with the objective of evaluating the efficacy and safety of an investigational product as an adjunct in the treatment of onychomycosis improvement of 90 days ± 2 days.

NCT ID: NCT02974387 Not yet recruiting - Clinical trials for Must be PRK Candidate

Safety and Efficacy of Lotemax Versus FML in Subjects Undergoing PRK for the Correction of Mild to Moderate Myopia, 3- Month Follow-up Study

Start date: April 2017
Phase: Phase 4
Study type: Interventional

STUDY OBJECTIVE: To evaluate and compare the safety and efficacy of (corneal Wound Healing and Intraocular Pressure) Fluorometholone and Loteprednol after photorefractive keratectomy (PRK) surgery. OVERALL STUDY DESIGN: Structure: Single-center, randomized, single blinded, contralateral (one eye receives FML, one eye Lotemax) Treatment Group: Patients will be randomized to the eye and will receive FML in one eye, Lotemax in contralateral eye Duration: 3 months Dosage/Dose Regimen: All patients will receive each one of the steroid agents 4 x a day for one month, 3 x a day for one month and 2 x a day for one month Study medication will be administered to the randomized eye through post op days according to mention protocol. Visit Schedule: baseline-screening, postop days 1, 7, 30 and then month 3th (through corneal re-epithelialization).

NCT ID: NCT03005236 Not yet recruiting - Clinical trials for Kidney Transplant Failure and Rejection

AGe-adapted Benefits of Envarsus Versus Twice-daily Tacrolimus ImmunosuppressioN druGs After Kidney Transplantation

AGEING
Start date: April 2017
Phase: Phase 4
Study type: Interventional

The proportion of elderly patients with end-stage kidney disease undergoing renal replacement therapy (RRT) is steadily increasing. Although kidney transplantation remains the optimal RRT of choice, it is clear that older adults have a differential risk versus benefit profile after kidney transplantation compared to younger adults. No age-adapted immunosuppression for older adults has been shown to improve kidney allograft outcomes but recent sub-analyses of clinical trial data has hinted at improved outcomes for older kidney transplant patients receiving Envarsus versus standard twice-daily tacrolimus formulations. This feasibility study will investigate this effect to see whether a full scale randomised controlled trial is warranted and to provide information regarding study feasibility.