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NCT ID: NCT04493424 Terminated - Clinical trials for Palmoplantar Pustulosis

A Study to Test Long-term Treatment With Spesolimab in People With Palmoplantar Pustulosis (PPP) Who Took Part in Previous Studies With Spesolimab

Start date: September 4, 2020
Phase: Phase 2
Study type: Interventional

This study is open to people with palmoplantar pustulosis who took part in previous clinical studies of a medicine called spesolimab. Participants who benefited from spesolimab treatment in the previous studies can join this study. The purpose of this study is to find out how safe spesolimab is and whether it helps people with palmoplantar pustulosis in the long-term. Participants are in this study for up to 5 years. During this time they visit the study site every month to get spesolimab injections under the skin. At study visits, doctors check the severity of participants' palmoplantar pustulosis and collect information on any health problems of the participants.

NCT ID: NCT04491071 Terminated - Stress Disorder Clinical Trials

Stress Induced by the COVID-19 Pandemic and Nonconfinement: Study of Anxiety Factors and Potential Effects on Immunity.

SCEI
Start date: October 22, 2020
Phase:
Study type: Observational

The aim of this project is to evaluate the impact of pandemic and nonconfinement related to anxiety and eventual immune diseases with several standardized questionnaires : Implant Stability Quotient (ISQ) , Generalized Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire -9 (PHQ-9), Post Traumatic Stress Disorder-8 (PTSD-8), and Experiences in Close Relationship Scale (ECRS).

NCT ID: NCT04489537 Terminated - Clinical trials for Hemophilia A With Inhibitor

Study of Coagulation Factor VIIa Marzeptacog Alfa (Activated) in Subjects With Hemophilia A or B

Start date: May 4, 2021
Phase: Phase 3
Study type: Interventional

The purpose of the trial is to evaluate the safety and efficacy of MarzAA for on-demand treatment and control of bleeding episodes in hemophilia A or B patients with inhibitors compared with their standard of care (SOC).

NCT ID: NCT04485663 Terminated - Chronic Hepatitis B Clinical Trials

A Study of ALG-010133 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single and Multiple Doses in Healthy Volunteers and CHB Subjects

Start date: August 17, 2020
Phase: Phase 1
Study type: Interventional

A Randomized Study of ALG-010133 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single and Multiple Doses in Healthy Volunteers and CHB Subjects

NCT ID: NCT04479436 Terminated - Clinical trials for Metastatic Colorectal Cancer

A Study to Evaluate U3-1402 in Subjects With Advanced or Metastatic Colorectal Cancer

Start date: September 14, 2020
Phase: Phase 2
Study type: Interventional

This study is designed to primarily evaluate the safety and efficacy of U3-1402 in participants with advanced or metastatic colorectal cancer (CRC) who have received at least 2 prior lines of therapy and will explore clinical benefit according to human epidermal growth factor receptor 3 (HER3) tumor expression level in otherwise refractory tumors.

NCT ID: NCT04478266 Terminated - Breast Cancer Clinical Trials

Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer

AMEERA-5
Start date: October 14, 2020
Phase: Phase 3
Study type: Interventional

Primary Objective: To determine whether Amcenestrant (SAR439859) in combination with palbociclib improves progression free survival (PFS) when compared with letrozole in combination with palbociclib in participants with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received any prior systemic anticancer therapies for advanced disease. Secondary Objective: - To compare the overall survival in both treatment arms. - To evaluate the objective response rate in both treatment arms. - To evaluate the duration of response in both treatment arms. - To evaluate the clinical benefit rate in both treatment arms. - To evaluate progression-free survival on next line of therapy. - To evaluate the pharmacokinetics of amcenestrant, and palbociclib. - To evaluate health-related quality of life in both treatment arms. - To evaluate the time to first chemotherapy in both treatment arms. - To evaluate safety in both treatment arms.

NCT ID: NCT04474314 Terminated - Sickle Cell Disease Clinical Trials

A Study of IMR-687 in Subjects With Sickle Cell Disease

Start date: August 13, 2020
Phase: Phase 2
Study type: Interventional

A Study to Evaluate the Safety and Efficacy of IMR-687 in Subjects with Sickle Cell Disease

NCT ID: NCT04469374 Terminated - Clinical trials for Osteoporosis, Postmenopausal

Menopause Osteoporosis and Bone Intervention Using Lifestyle Exercise.

MOBILE
Start date: December 1, 2019
Phase: N/A
Study type: Interventional

Aim: to examine the effect of an exercise intervention for preventing osteoporosis among postmenopausal women. Objectives: To examine whether mean values for Broadband Ultrasound Attenuation (BUA) using Quantitative Ultrasound (QUS) among postmenopausal women following an eight-month exercise intervention (and at 3-month follow up), will be significantly higher than those obtained pre-intervention. To examine whether mean BUA values among postmenopausal women following an eight-month exercise intervention (and at 3-month follow up) will be significantly higher than mean values obtained from participants in a control group undertaking sham exercises for an equivalent duration. To examine the feasibility of the eight-month exercise intervention for a potential larger study (larger sample size, increased number of trial arms and increased outcome measures), in terms of recruitment, adherence, perceptions, barriers, and acceptability.

NCT ID: NCT04462757 Terminated - COVID-19 Clinical Trials

SCIL-1Ra in COVID-19 Feasibility & PK/PD

SCIL_COV19
Start date: May 28, 2020
Phase: Phase 2
Study type: Interventional

The current COVID-19 pandemic is a worldwide healthcare crisis. Of concern is the large number of patients that are/will require mechanical ventilation, and the associated strain that this will place on healthcare resources. At present, there are no specific therapeutic interventions directed at COVID-19 infection. However, observational data suggest that there is a subgroup of patients that demonstrate a hyperinflammatory response in response to COVID-19 and have a higher requirement for Critical Care and higher mortality. There is a strong case for the use of the naturally occurring anti-inflammatory cytokine interleukin-1 receptor antagonist (IL-1Ra) in these patients. Anakinra is a recombinant form of IL-1Ra that is licensed for clinical use. Success of use of anakinra in COVID-19 trials will be greatly enhanced by robust scientific evidence and established pharmacokinetics which inform the most effective dosing regimens. The latter is especially important when, as in the case of anakinra, drug supplies are limited, the drug has short half-life and clinical ease of application is critical.

NCT ID: NCT04461600 Terminated - Clinical trials for Triple Negative Breast Cancer

A Study of AL101 Monotherapy in Patients With Notch Activated Triple Negative Breast Cancer

TENACITY
Start date: August 14, 2020
Phase: Phase 2
Study type: Interventional

The current study is designed to evaluate the efficacy and safety of AL101 monotherapy in subjects with Notch-activated recurrent or metastatic TNBC; Notch activation will be determined by a Next Generation Sequencing (NGS) test.