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NCT ID: NCT04994119 Completed - Clinical trials for Pulmonary Arterial Hypertension

Effect of BIA 5-1058 400 mg on Warfarin Pharmacokinetics

Start date: February 23, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is: - To investigate CYP2C9 inhibition by BIA 5-1058 through the assessment of its effect on the Pharmacokinetic (PK) of S-warfarin, a substrate of CYP2C9. - To assess the effect of warfarin on the PK of BIA 5-1058.

NCT ID: NCT04993989 Completed - Clinical trials for Functional and Motility Related Gastrointestinal Disorders Such as Irritable Bowel Syndrome and Functional Dyspepsia

A Pharmacy-based Study to Learn More About How Well Iberogast Works, How it Affects the Body, How it is Used, and User Satisfaction in Patients With Functional and Motility-related (Stomach and Bowel Movement-related) Gastrointestinal Diseases, Including Irritable Bowel Syndrome

Start date: November 16, 2017
Phase:
Study type: Observational

Researchers want to learn more about the day-to-day use of Iberogast in people who have functional and motility-related gastrointestinal (stomach and bowel) diseases. Functional and motility-related stomach and bowel diseases are conditions in which the functionality of the gut, mainly the gut muscles or the gut/brain axis is disturbed. Functional and motility related stomach and bowel diseases cause symptoms like heartburn, cramps and u pain of the upper and middle part of the belly, also known as functional dyspepsia (FD), and irritable bowel syndrome (IBS). IBS affects predominantly the lower digestive system and causes symptoms like pain of the belly, cramps, bloating, diarrhea, and constipation. In this study, the researchers want to learn more about Iberogast, a plant-based treatment. Iberogast is available to treat stomach and bowel diseases such as FD and IBS. Earlier studies with Iberogast have shown how well it works and how it affects the body. But, little is known about the day-to-day use of Iberogast and how satisfied patients are who take it. So in this study, the researchers want to learn more about Iberogast including: - how well it works in day-to-day use - how it affects the body, also referred to as tolerability - how it is used day-to-day - how safe it is - how satisfied patients are who take it To answer these questions, the researchers will collect information from pharmacies in Germany. Patients who get Iberogast from these pharmacies to help treat their gastrointestinal disease will complete a questionnaire before, during and after taking Iberogast. The researchers will use the results from the questionnaires to learn more about: - the disease details of the patients who are taking Iberogast - the patients' symptoms while taking Iberogast - if the patients' symptoms change after taking Iberogast - how satisfied patients are with Iberogast - if the patients had adverse events An adverse event is any medical problem that a participant has during a study. This study will include patients in Germany who: - have functional stomach and bowel symptoms or disorders like FD or IBS - take Iberogast to treat symptoms of their stomach and bowel disease - are able to complete the questionnaire There will be no required tests or visits with a study doctor in this study. No treatments will be given as part of this study. The researchers will review information collected from patients who have decided for their own or by recommendation of their doctors or pharmacist to take Iberogast. The researchers will collect the results from the patient questionnaires from November 2017 to March 2018.

NCT ID: NCT04992585 Completed - Clinical trials for Bile Duct Obstruction

Primary Versus Secondary Metal Stent Implantation in PTBD

Start date: March 1, 2011
Phase: N/A
Study type: Interventional

The aim is to compare percutaneous transhepatic biliary drainage (PTBD) with primary metal stent implantation (one stage-procedure) with PTBD with secondary metal stent implantation in terms of adverse events.

NCT ID: NCT04992065 Completed - Clinical trials for Atherosclerotic Cardiovascular Disease

A Research Study Looking at How NNC0385-0434 Tablets Work to Lower Blood Cholesterol in People With Heart Disease or a High Risk of Heart Disease

Start date: August 3, 2021
Phase: Phase 2
Study type: Interventional

This study looks at how well a new medicine, NNC0385-0434, works to lower blood cholesterol levels. Participants will either get NNC0385-0434 as a tablet (a potential new medicine), or placebo as a tablet (a dummy medicine that looks like NNC0385-0434 but has no effect on the body), or evolocumab as an injection (a medicine that doctors can already prescribe). Which treatment participants get is decided by chance. If participants get NNC0385-0434 or placebo participants will need to take 1 tablet every morning. If participants get evolocumab participants will need to take 1 injection every 2 weeks. The study will last for about 22 weeks. About 255 people will participate in the study. Participants will have 9 visits to the clinic and 2 phone calls with the study doctor. Some people will be invited to participate in a sub-study and will have 4 extra visits (13 visits in total). Participants will have blood samples taken at all visits to the clinic (except visit 0). At 4 clinic visits, participants will have an electrocardiogram (ECG). This is a test to check your heart. Women can only take part in the study if they are not able to become pregnant.

NCT ID: NCT04991753 Completed - Clinical trials for Arthritis, Rheumatoid

A Proof-of-concept Study of the Efficacy and Safety of Nipocalimab in Participants With Active Rheumatoid Arthritis

Start date: October 14, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of nipocalimab versus placebo in participants with moderate to severe active rheumatoid arthritis (RA).

NCT ID: NCT04991207 Completed - Clinical trials for Pulmonary Arterial Hypertension

Effect of BIA 5-1058 400 mg on the Steady State Pharmacokinetics of Bosentan

Start date: February 6, 2018
Phase: Phase 1
Study type: Interventional

the purpose of this study is: - To assess the effect of BIA 5 1058 400 mg on the PK of bosentan. - To assess the effect of bosentan on the PK of BIA 5 1058

NCT ID: NCT04990882 Completed - Malignant Neoplasm Clinical Trials

FAPI PET/CT Prospective Interobserver Agreement

AGREE-FAPI
Start date: September 1, 2021
Phase:
Study type: Observational [Patient Registry]

The aim of the present study is to evaluate the interobserver agreement for FAPI PET/CT interpretations of representative cancer types and compare findings among readers with different levels of experience.

NCT ID: NCT04989842 Completed - Mental Disorder Clinical Trials

Effectiveness and Equivalence of an Internet-based Virtual Classroom Intervention for Psychosomatic Aftercare

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

Outpatient psychosomatic aftercare after inpatient rehabilitation pursues the goal of helping patients to transfer the achieved rehabilitation result in everyday life and professional life. The Hanover Curriculum has been established as a treatment programme for psychosomatic aftercare. This comprises 25 weekly group sessions and two single therapies at the beginning and at the end of the therapy. In Germany a vast majority of rehabilitants in a psychosomatic rehabilitation clinic has an indication for psychosomatic aftercare, but it is used only by less than half of the patients due to a lack of aftercare therapists. If there is a therapist in the patient's vicinity, there are often long travelling times to the therapist or the patients might feel stigmatized participating in a face-to-face therapy. Thus, the expansion of internet-based aftercare services is recommended. Advantages are that they can be carried out at home, possible cost and time savings and improvement of the care situation. Several meta-analyses provide high evidence for the effectiveness of internet-based therapy offers in depressive and anxiety disorders that are frequent among psychosomatic rehabilitation patients. First randomised controlled studies show that internet-based aftercare services can lead to a symptomatic improvement and to a reduction of relapses. It is currently not clear whether established aftercare concepts, such as the Curriculum Hannover, are also effective in an internet-based format (Curriculum Hannover Online). The present project consists of a superiority study, examining whether participation in Curriculum- Hannover-Online leads to a stronger adoption and maintenance of the health improvements achieved in inpatient rehabilitation in comparison to care as usual, and an equivalnece study, examining, wether the Curriculum Hannover Online is an equivalent treatment option to the existing face-to-face aftercare therapy.

NCT ID: NCT04989595 Completed - Clinical trials for Uterine Bleeding Profile Prediction

A Study to Learn More About How a Smartphone App Called MyIUS Predicts Future Menstrual Bleeding in Women After They Have Begun Using Intrauterine Birth Control Method (a Birth Control Device is Inserted Into a Woman's Uterus by Her Doctor)

MyIUS
Start date: September 17, 2021
Phase:
Study type: Observational

Researchers are looking to learn more about future menstrual bleeding in women who have started using intrauterine contraception methods. "Intrauterine contraception" means that a device is inserted into a woman's uterus by her doctor. The device then releases a birth control treatment into the uterus. Researchers have found that when women use intrauterine contraception, its effects on the menstrual cycle can cause changes to how often and for how long women will bleed. This is one of reasons women may stop using their intrauterine contraception. So, the researchers in this study wanted to learn about a tool that can be used to predict future bleeding events. This tool was developed based on the results of previous clinical studies that researched menstrual bleeding. This tool is a smartphone application called MyIUS. This study will include about 3,000 women who have recently had intrauterine contraception inserted and who use the MyIUS app. There will be no visits with a study doctor in this study. After the intrauterine contraception has been inserted, the women will start to record any events of bleeding in the MyIUS app. After they have recorded events of bleeding for a total of 90 days, the MyIUS app will give a prediction of menstrual bleeding expected for the next 180 days. The women who sign the electronic informed consent form will continue to record their bleeding events for a total of 6 months. The researchers will then collect this information. They will use this information to find out how well the MyIUS app can predict future menstrual bleeding.

NCT ID: NCT04983914 Completed - Clinical trials for Retinitis Pigmentosa

Retrospective NIS to Evaluate the Patient Benefit of TES

Start date: September 6, 2021
Phase:
Study type: Observational

In this retrospective non-interventional study (NIS), the subjective and objective benefit of patients with retinitis pigmentosa (and other dystrophies like Usher, Choroideremia or cone-rod dystrophy), who have been prescribed the therapy of transcorneal electrostimulation (TcES) with the OkuStim System, is assessed.