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NCT ID: NCT04204252 Recruiting - Clinical trials for Alpha 1-Antitrypsin Deficiency

Evaluate Efficacy and Safety of "Kamada-AAT for Inhalation" in Patients With AATD

InnovAATe
Start date: November 25, 2019
Phase: Phase 3
Study type: Interventional

The current study population will consist of adult patients with congenital alpha-1 antitrypsin (AAT) deficiency who have moderate or severe airflow limitation (forced expiratory volume in 1 second 40% ≤ [FEV1] ≤ 80% of predicted) and FEV1/slow vital capacity [SVC] ≤ 70% and who have not experienced two or more moderate or one or more severe exacerbations of COPD during the past year. A total of 220 patients will be recruited, and after 4 weeks practice inhaling saline with the nebulizer, will be randomized 1:1 to inhale either 80 mg/day "Kamada-AAT for Inhalation" or a placebo with identical appearance. Patients will be treated for 104 weeks and then followed up for a further 26 weeks. Over this time there will be 13 visits to the clinical site and in addition the patients will be required to fill out a daily e-diary.

NCT ID: NCT04203576 Recruiting - Heart Failure Clinical Trials

First in Human Clinical Investigation of the FIRE1 System in Heart Failure Patients (FUTURE-HF)

Start date: November 22, 2019
Phase: N/A
Study type: Interventional

First in Human Clinical Investigation of the FIRE1 Device/System to evaluate the feasibility and safety of implanting the FIRE1 system in stable HF patients.

NCT ID: NCT04191694 Recruiting - PONV Clinical Trials

Chewing Gum to Prevent Nausea and Vomiting After Caesarean Section Under Spinal Anaesthesia

Start date: October 28, 2019
Phase: N/A
Study type: Interventional

Our study aims to determine if there is a difference in a self-reported incidence of nausea and vomiting in women who are given chewing gum following elective caesarean section under spinal anaesthesia compared to those who do not receive chewing gum

NCT ID: NCT04179487 Recruiting - Pregnancy Related Clinical Trials

The OPTICA Study - The Optimised Computed Tomography Pulmonary Angiography (CTPA) in Pregnancy, Quality and Safety Study

OPTICA
Start date: May 29, 2018
Phase:
Study type: Observational

A prospective multicentre study aiming to validate the clinical utility and safety of an optimised low-dose computed-tomography pulmonary angiogram (CTPA) protocol for suspected pulmonary embolism in pregnancy

NCT ID: NCT04174755 Recruiting - Obesity Clinical Trials

Semaglutide's Efficacy in Achieving Weight Loss for Those With HIV

SWIFT
Start date: June 22, 2022
Phase: N/A
Study type: Interventional

The prevalence of obesity is rising worldwide, both in low- and high-income countries, including people with HIV (PWH). Semaglutide's efficacy in achieving weight loss in obese PWH is still unexplored. The aim of this study is to assess the efficacy and safety of semaglutide in achieving greater weight loss compared to diet and excercise alone in obese PWH and to explore the effect of semaglutide on the immune function, markers of immune activation, viral reservoir, markers of glucose and lipid metabolism and gut microbiome.

NCT ID: NCT04174157 Recruiting - Clinical trials for Spinal Muscular Atrophy (SMA)

Registry of Patients With a Diagnosis of Spinal Muscular Atrophy (SMA)

Start date: September 25, 2018
Phase:
Study type: Observational [Patient Registry]

Spinal muscular atrophy (SMA) is a neurogenetic disorder caused by a loss or mutation in the survival motor neuron 1 gene (SMN1) on chromosome 5q13, which leads to reduced SMN protein levels and a selective dysfunction of motor neurons. SMA is an autosomal recessive, early childhood disease with an incidence of 1:10,000 live births. SMA is the leading cause of infant mortality due to genetic diseases. Until recently, the mainstay of treatment for these patients was supportive medical care. However, advances in medical treatment focusing on gene replacement, gene enhancement, motor neuron protection and muscle enhancement is likely to change the management and prognosis of these patients in the future. The purpose of this registry is to assess the long term outcomes of patients with SMA in the context of advances in treatment options.

NCT ID: NCT04173273 Recruiting - Crohn's Disease Clinical Trials

A Study Evaluating the Efficacy and Safety of Oral Etrasimod in the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease

CULTIVATE
Start date: January 6, 2020
Phase: Phase 3
Study type: Interventional

This is a Phase 2/3 study that comprises 5 substudies designed to evaluate the efficacy, safety, and tolerability of oral etrasimod as therapy in adult participants with moderately to severely active Crohn's disease (CD) who are refractory or intolerant to at least 1 of the current therapies for CD (ie, corticosteroids, immunosuppressants, or biologics). The overall duration of this study is up to 282 weeks, inclusive of the Screening Period, Treatment Period of up to 274 weeks (Induction, Extension or Maintenance, and Long-term Extension Periods), and the 4-Week Follow-Up Period for safety assessment.

NCT ID: NCT04159948 Recruiting - Fasting Clinical Trials

Preoperative Carbohydrate Drink Prior to Elective Caesarean Section

Start date: January 20, 2020
Phase: N/A
Study type: Interventional

Prior to caesarean section, patients should fast from solid food for 6 hours and from clear fluids for 2 hours. Carbohydrate drinks can also be consumed up to 2 hours before surgery. These drinks have been shown to improve patient well-being after surgery and may potentially improve the neonatal blood glucose level after delivery and reduce the risk of a low blood glucose level. This study aims to assess the influence of pre-operative carbohydrate drinks on blood glucose levels of the baby at delivery.

NCT ID: NCT04152044 Recruiting - Obesity Clinical Trials

Obesity and Liver Function in Oesophageal Cancer

Start date: November 1, 2019
Phase:
Study type: Observational

There is an established link between sarcopenia and outcomes in oesophageal cancer. There is scant reports in the literature regarding the influences of different obesity in different compartments.

NCT ID: NCT04142437 Recruiting - Clinical trials for Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion

Study to Learn More About the Safety and Effectiveness of the Drug VITRAKVI During Routine Use in Patients With TRK Fusion Cancer Which is Locally Advanced or Spread From the Place Where it Started to Other Places in the Body

ON-TRK
Start date: April 3, 2020
Phase:
Study type: Observational

In this observational study researcher want to learn more about the effectiveness of drug VITRAKVI (generic name: larotrectinib) and how well the drug is tolerated during routine use in patients with TRK fusion cancer which is locally advanced or spread from the place where it started to other places in the body. TRK fusion cancer is a term used to describe a variety of common and rare cancers that are caused by a change to the NTRK (Neurotrophic Tyrosine Kinase) gene called a fusion. During this fusion, an NTRK gene joins together, or fuses, with a different gene. This joining results in the activation of certain proteins (TRK fusion proteins), which can cause cancer cells to multiply and form a tumor. VITRAKVI is an approved drug that blocks the action of the NTRK gene fusion. This study will enroll adult and paediatric patients suffering from a solid tumor with NTRK gene fusion for whom the decision to treat their disease with VITRAKVI has been made by their treating physicians. During the study, patients' medical information such as treatment information with VITRAKVI, other medication or treatments, changes in disease status and other health signs and symptoms will be collected within the normal medical care by the treating doctor. Participants will be observed over a period from 24 to 60 months.