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NCT ID: NCT04195906 Completed - Calciphylaxis Clinical Trials

Phase 3 Study of SNF472 for Calciphylaxis

Calciphyx
Start date: February 12, 2020
Phase: Phase 3
Study type: Interventional

The primary objectives are to assess the efficacy, safety, and tolerability of SNF472 compared to placebo when added to background care for the treatment of calciphylaxis (CUA).

NCT ID: NCT04195698 Completed - Atopic Dermatitis Clinical Trials

Open-Label Extension Study of Upadacitinib in Adult Participants With Moderate to Severe Atopic Dermatitis

Start date: January 15, 2020
Phase: Phase 3
Study type: Interventional

This is a study for adults (18-75 years) who have successfully completed treatment either with Dupilumab or with Upadacitinib in the study M16-046. At the end of M16-046, they have the option to receive Upadacitinib with a duration of 52 weeks beyond the timeframe of Study M16-046. There will be a 30 day follow-up visit after the treatment period is completed. Main objective of this study is to assess long-term safety, tolerability and efficacy of upadacitinib in participants with moderate to severe atopic dermatitis who successfully completed treatment in the study M16-046.

NCT ID: NCT04194645 Completed - Healthy Clinical Trials

A Study in Healthy Men to Test How the Body Takes up and Tolerates Different Doses of BI 474121, and Whether it Makes a Difference if BI 474121 is Taken as a Tablet or a Drink.

Start date: January 9, 2020
Phase: Phase 1
Study type: Interventional

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 474121 in healthy male subjects following oral administration of single rising doses.

NCT ID: NCT04194398 Completed - OCS Lung System Clinical Trials

OCS Lung Expand Post-Approval Study - Expand Follow-Up Data Collection

Start date: December 31, 2018
Phase:
Study type: Observational

Collection of five year follow-up data on patients who have already participated in the EXPAND Lung trial and have had transplants with donor lungs preserved on the OCS Lung System.

NCT ID: NCT04193202 Completed - Chronic Cough Clinical Trials

Efficacy and Safety of Gefapixant (MK-7264) in Adult Participants With Recent Onset Chronic Cough (MK-7264-043)

Start date: May 21, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of gefapixant in participants with recent onset chronic cough (duration >8 weeks after onset of cough symptoms) for <12 months and a diagnosis of refractory or unexplained chronic cough. The primary hypothesis is that gefapixant is superior to placebo in improving cough-related quality of life measured as change from baseline in the Leicester Cough Questionnaire (LCQ) total score at Week 12.

NCT ID: NCT04193176 Completed - Chronic Cough Clinical Trials

Efficacy and Safety of Gefapixant (MK-7264) in Women With Chronic Cough and Stress Urinary Incontinence (MK-7264-042)

Start date: May 10, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of gefapixant, in improving symptoms of cough-induced stress urinary incontinence (SUI) in adult female participants with refractory or unexplained chronic cough. The primary hypothesis is that gefapixant is superior to placebo in reducing the frequency of cough-induced SUI episodes over 12 weeks.

NCT ID: NCT04193046 Completed - Clinical trials for Hypertension, Pulmonary

A Study for the Identification of Biomarker Signatures for Early Detection of Pulmonary Hypertension (PH)

CIPHER
Start date: December 16, 2019
Phase: Early Phase 1
Study type: Interventional

The primary purpose of this study is to identify and develop biomarker signatures based on circulating micro ribonucleic acid (RNA) in the blood samples associated with high risk of pulmonary hypertension (PH) to assist in the diagnosis of PH; to estimate the sensitivity, specificity, positive predictive value, and negative predictive value of the biomarker signatures in identifying participants with PH by comparing the biomarker signatures to right heart catheterization (RHC) and to compare the sensitivity, specificity, positive predictive value, and negative predictive value of the biomarker signatures with the sensitivity, specificity, positive predictive value, and negative predictive value of transthoracic echocardiogram (TTE) in identifying participants with PH documented by RHC.

NCT ID: NCT04192916 Completed - Clinical trials for Myeloproliferative Neoplasm

Use of Direct Oral Anticoagulants (DOACs) in Patients With Ph-negative Myeloproliferative Neoplasms

MPN-DOACs
Start date: September 1, 2019
Phase:
Study type: Observational

Patients with myeloproliferative neoplasms (MPN) are predisposed to have an increased thrombotic and hemorrhagic risk and, in this context, the use of newly approved direct oral anticoagulants (DOACs) may have improved bleeding risk compared to warfarin use. However, the published experience is very limited and does not allow any conclusion. In the cohort of patients with MPN and venous thromboembolism (VTE) of European Leukemia-net, only 3.3% of patients had been treated with DOACs. Similarly, in a recent publication of a series of 760 patients with single-center MPN, only 25 (3.3%) were treated with a DOAC (13 for atrial fibrillation and 12 for thrombotic events). While it is known that the risk of thrombotic recurrence and haemorrhagic event during warfarin treatment is about 30% at 5 years from the first event, the actual risk of such events in MPN patients is not known. The aim of the present study is therefore to obtain information on patients with MPN treated with DOAC for atrial fibrillation (AF) and VTE. This is an international multi-center retrospective survey aimed at describing the efficacy / safety of DOAC in the prevention of: - cardioembolic stroke in patients with MPN with AF - recurrent thrombosis in patients with MPN with VTE - major bleeding in all patients with MPN. The results will allow to design future prospective studies that evaluate the benefit / risk profile of DOAC compared to warfarin in these pathologies characterized by high risk of thrombosis and, in some subgroups, of bleeding.

NCT ID: NCT04192188 Completed - Periodontitis Clinical Trials

Supportive Periodontal Therapy Under Antiresorptive Therapy

Start date: December 6, 2019
Phase:
Study type: Observational

This observational study investigates the one-point in time and course of clinical periodontal and dental parameters during supportive periodontal therapy in patients under and without antiresorptive medication.

NCT ID: NCT04192123 Completed - Intact Skin Clinical Trials

Open-Label Test of the HM242 Medical Devices to Evaluate Safety and Local Tolerability

Start date: May 25, 2020
Phase: N/A
Study type: Interventional

It is the first clinical study aimed at assessing the safety and tolerability of HM242-Solution and HM242-Gel after their application under occlusion on intact skin. The HM242-Solution is intended for chronic wounds (e.g. pressure, venous leg and diabetic foot ulcers). The HM242-Solution should be used for physical rinsing and cleansing and subsequent decolonization of the wound prior to treatment with hydrogels and dressings. The HM242-Gel is a hydrogel for wound bed preparation to support the healing of the skin due to cleansing, moistening and subsequent decolonization and the coating of the wound. The study will be conducted in outpatient manner, adult patients who are healthy and has an intact skin. This is an prospective, open label, monocentric study. No comparative control group is planned as no other preventing infection solution is commercially available at this time.