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NCT ID: NCT04003155 Completed - Hot Flashes Clinical Trials

A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women Going Through Menopause

Skylight 1
Start date: July 11, 2019
Phase: Phase 3
Study type: Interventional

This study was for women in menopause with moderate to severe hot flashes. Menopause, a normal part of aging, is the time of a woman's last period. Hot flashes can interrupt a woman's daily life. The study treatments were fezolinetant 30 milligrams (mg) (1 tablet of fezolinetant and 1 placebo tablet) once a day, fezolinetant 45 mg (2 tablets of fezolinetant) once a day or placebo (2 tablets) once a day. (Placebo was a dummy treatment that looks like medicine but did not had any medicine in it.) The study compared fezolinetant and placebo after 4 and 12 weeks of dosing. The study evaluated if fezolinetant reduces the number of hot flashes. And the study evaluated if fezolinetant reduces the severity of the hot flashes. Women in the study received an electronic handheld device at the first study visit. (It was similar to a smart phone.) Each day of the study, study participants used this to record their hot flashes. Their record for the 10 days before the start of study treatment was checked. They remained in the study if their record shown 7 or 8 moderate to severe hot flashes per day (50 or more per week). Next, they were picked for 1 of the 2 study treatments (fezolinetant or placebo) by chance alone. It was like flipping a coin. The study participants took study treatment for 52 weeks. The first 12 weeks of study treatment are "double-blinded." That means that the study participants and the study doctors did not knew who took which of the study treatments (fezolinetant 30 mg, fezolinetant 45 mg or placebo) during that time. The last 40 weeks of study treatment are "noncontrolled." That means that each study participant and the study doctors knew which study treatment that study participant took during that time. Women who took fezolinetant during the first 12 weeks continued to take the same dose. Women who took placebo during the first 12 weeks took fezolinetant. Their dose was either 30 mg or 45 mg fezolinetant. At weeks 2, 4, 8, 12, 14, 16 and then once a month, the study participants visited the hospital or clinic for a check-up. They were asked about medications, side effects and how they felt. Other checks included physical exam and vital signs (heart rate, temperature and blood pressure). Blood and urine was collected for laboratory tests. Study participants completed questionnaires that were about how hot flashes affect their daily life. Study participants who still had their uterus had the following 2 tests done at the first and last study visits. One of the 2 tests was endometrial biopsy. This test involves removing a small amount of tissue from the inside lining of the uterus. The tissue was then checked under a microscope. The other test is transvaginal ultrasound. This test used sound waves to create pictures of the organs in the pelvis. The sound waves were transmitted by a probe (transducer), which was placed inside the vagina. Study participants may have a screening mammogram done at the first and/or last study visit. A mammogram is an x-ray picture of the breasts used to screen for breast cancer. Study participants who did not had this test done in the last 12 months had it done at the first study visit. They had it done at the last study visit if they are due for their screening mammogram and their own doctor agrees. The last check-up at the hospital or clinic was 3 weeks after the last dose of study treatment.

NCT ID: NCT04002609 Completed - NIRS Clinical Trials

The Systemic and Brain Oxygen Stauration Change During Bronchoscopy

BFNIRS
Start date: June 30, 2017
Phase:
Study type: Observational

Bronchofiberoscopy is a widespread invasive intervention in clinical practice with a number of diagnostic and therapeutic indications. The Clinic of Pulmonary Medicine in Debrecen carries out nearly 2000 examinations a year. The intervention is guided by the recommendation of the Vocational College for Pulmonary Medicine in 2005, but it does not contain a clear recommendation on the oxygen therapy used during the intervention. The Hungarian recommendation states that pulsoximetry is mandatory in bronchoscopy, but it does not contain information on the indications and the implementation of oxygen suplementation. The British Thoracic Society Guideline 2013 deals with the issue and makes the following statements: - patients should be monitored for oxygen saturation under bronchofiberoscopy - oxygen supplementation during the test is recommended if the patient's desaturation is significant (greater than 4% or less than 90%) and is over 1 minute - during the bronchoscopy, the occurrence of oxygen saturation decreases depending on the level of initial oxygen saturation, respiratory function, co-morbidity, sedation and the course of intervention. The aim of our study is to investigate the frequency with which systemic hypoxia occurs during bronchoscopy, what factors may contribute to its development and how the level of cerebral oxygen saturation changes with systemic desaturation (in the case of NIRS, a 20% reduction from baseline is considered significant).

NCT ID: NCT03998163 Completed - Uremic Pruritus Clinical Trials

CR845-CLIN3105: A Study to Evaluate the Safety and Effectiveness of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus

Start date: May 6, 2019
Phase: Phase 3
Study type: Interventional

This is a multicenter, open-label study to evaluate the safety and effectiveness of intravenous (IV) CR845 at a dose of 0.5 mcg/kg administered after each dialysis session. The study includes an up to 12-week Treatment Period.

NCT ID: NCT03996447 Completed - Clinical trials for Blood Brain Barrier Defect

Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

PICTURE
Start date: June 3, 2019
Phase: Phase 3
Study type: Interventional

the trial aims to evaluate the Efficacy and Safety of gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

NCT ID: NCT03996369 Completed - Ulcerative Colitis Clinical Trials

Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis

ELEVATE UC 12
Start date: September 15, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy of etrasimod on clinical remission in participants with moderately to severely active ulcerative colitis (UC).

NCT ID: NCT03992846 Completed - Endometriosis Clinical Trials

Efficacy and Safety of Linzagolix for the Treatment of Endometriosis-associated Pain.

Start date: June 13, 2019
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to demonstrate the efficacy and safety of linzagolix administered orally once daily for 3 months at a dose of 75 mg alone or of 200 mg in combination with add-back hormone replacement therapy (ABT: estradiol (E2) 1 mg / norethisterone acetate (NETA) 0.5 mg) versus placebo, in the management of moderate to severe endometriosis-associated pain (EAP).

NCT ID: NCT03990363 Completed - Clinical trials for Chronic Kidney Disease

A Study of Verinurad and Allopurinol in Patients With Chronic Kidney Disease and Hyperuricaemia

SAPPHIRE
Start date: July 23, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this clinical research study is to establish the dose of verinurad combined with allopurinol 300 mg once daily that will elicit the desired response; ie, reduction in urinary albumin to creatinine ratio (UACR) at 6 months.

NCT ID: NCT03989349 Completed - Clinical trials for Moderate-to-Severe Atopic Dermatitis

Efficacy & Safety of Nemolizumab in Subjects With Moderate-to-Severe Atopic Dermatitis

Start date: June 30, 2019
Phase: Phase 3
Study type: Interventional

The main purpose of the study is to assess the efficacy and safety of nemolizumab after a 16-week treatment period in adult and adolescent subjects with moderate-to-severe atopic dermatitis (AD) not adequately controlled with topical treatments.

NCT ID: NCT03989232 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Research Study to Compare Two Doses of Semaglutide Taken Once Weekly in People With Type 2 Diabetes

SUSTAIN FORTE
Start date: June 19, 2019
Phase: Phase 3
Study type: Interventional

This study compares the effect of two doses of semaglutide (1.0 mg and 2.0 mg) in people with type 2 diabetes (T2D). People taking part in the study will take the medicine together with their current diabetes medicine (sulphonylurea and/or metformin). Participants will get a dose of either 1.0 mg or 2.0 mg semaglutide once a week - which dose is decided by chance. Participants will inject semaglutide under the skin once a week. The study will last for about 49 weeks. Participants will have 9 clinic visits and 2 phone calls with the study doctor. At the visits participants will have blood taken and eye tests done. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period. Female participants who can get pregnant will be checked 11 times for pregnancy via urine tests.

NCT ID: NCT03987607 Completed - Clinical trials for Neuromuscular Blockade

Comparison of Two Monitors That Measure Neuromuscular Function During Surgeries

Start date: June 17, 2019
Phase:
Study type: Observational

Anesthesiologists are often required to give certain drugs, called muscle relaxants to the patients for surgery. These drugs make the people weak for the procedure to make the work of the surgeon easier and prevent unexpected movements. The effect of these drugs must be terminated by the end of the procedures to ensure that the patients can breathe normally. Over the years several monitors have been developed to monitor the effect of these drugs. The monitors use different principles to measure muscle function. Some monitors are integrated into anesthesia machines while others are battery-operated, portable devices. The aim of the present study is two compare monitors using different technologies. Both monitors stimulate a peripheral nerve at the wrist that makes the thumb twitch. The older device (TOF-Watch SX) measures the acceleration of thumb movement, the new device (TetraGraph) measures the electrical activity of the muscle that moves the thumb. The two devices will be connected so that with one simulation both types of signals can be recorded and analyzed. The monitors will be used during the surgeries as described by the manufacturer. The study will not influence the surgical procedure or the anesthetic of the patients. The aim of the study is to collect data on how the two monitors correlate, since they measure neuromuscular function by different technologies (acceleromyography and electromyography).