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NCT ID: NCT04505787 Completed - Clinical trials for Comparative Bioavailability

S-flurbiprofen Bioavailability Trial to Compare a Newly Developed Patch vs. a Marketed Tablet

Start date: July 24, 2020
Phase: Phase 1
Study type: Interventional

Teikoku Seiyaku Co., Ltd. (Japan) is developing a new Esflurbiprofen Hydrogel Patch (EFHP), a transdermal product containing 165 mg of the S-enantiomer of flurbiprofen (S-flurbiprofen) as its active pharmaceutical ingredient. The present clinical trial will be conducted to characterise maximum observed systemic exposure of the newly developed EFHP (Test) vs. "Froben 100 mg" (Reference, containing 100 mg racemic flurbiprofen in a 1:1 ratio). Characterisation will be performed under steady state conditions in order to bridge the available safety information on the basis of the comparison of maximum observed systemic exposure by means of AUC0-24h,ss,P vs. AUC0-24,ss,T and Cmax,ss,P vs. Cmax,ss,T of S-flurbiprofen.

NCT ID: NCT04504994 Completed - Clinical trials for Borderline Personality Disorder

Stress & Social Cognition in Borderline Personality Disorder

SOKO-1
Start date: February 1, 2020
Phase: N/A
Study type: Interventional

The investigators will examine whether perceived social exclusion provoke a reduction in prosocial behavior in BPD patients.

NCT ID: NCT04504383 Completed - Clinical trials for Ulcerative Colitis Chronic Moderate

PN-943 in Adults With Moderate to Severe Active Ulcerative Colitis (UC)

Start date: August 5, 2020
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the safety, tolerability, and clinical efficacy of PN-943 450 mg twice daily [BID] and PN-943 150 mg BID, compared with placebo BID, in subjects with moderate to severe active Ulcerative Colitis (UC).

NCT ID: NCT04502862 Completed - Asthma Clinical Trials

A Phase 4, Randomized, Double-blind, Placebo-controlled,Multicenter, Parallel-group Study of the Effect of Dupilumab on Sleep Disturbance in Patients With Uncontrolled Persistent Asthma

MORPHEO
Start date: August 10, 2020
Phase: Phase 4
Study type: Interventional

Primary Objective: To assess the effect of dupilumab on sleep Secondary Objectives: - To evaluate the effect of dupilumab on additional patient reported sleep outcomes - To evaluate the effect of dupilumab on objective sleep assessment - To evaluate the effect of dupilumab on asthma symptoms - To evaluate the effect of dupilumab on lung function - To evaluate the safety of dupilumab

NCT ID: NCT04502121 Completed - Clinical trials for Cardiac Valve Disease

Preoperative Optimization of Cardiac Valve Patients' Expectations

ValvEx
Start date: July 17, 2020
Phase: N/A
Study type: Interventional

Recovery after surgery depends on psychological factors such as preoperative information, expectations and surgery-associated anxiety. Prior studies have shown that even short preoperative psychological interventions can improve postoperative outcomes in heart surgery patients. However, what content works best for which patient group and how long an intervention has to be is still largely unknown. The aims of this study are thus to examine if the developed preoperative psychological intervention (i) reduces preoperative anxiety, (ii) increases positive expectations, and (iii) improves the long-term outcome postoperative recovery. Therefore, a brief intervention has been developed. Heart valve patients who undergo a heart surgery will be randomized into two groups (Control vs. intervention group) after baseline assessment. Following this the intervention group will participate in the psychological intervention (30-40 minutes). To increase patients' positive expectations the intervention will focus on treatment outcome expectations and personal control expectations. Furthermore, patients in the intervention group will have two booster-telephone calls (four and eight weeks after the surgery) to check if their developed plans work out. The control group will receive the standard medical procedure. Both groups will fill out questionnaires again at the evening before the surgery, around one week after the surgery and three months after surgery.

NCT ID: NCT04501692 Completed - Airway Management Clinical Trials

VivaSight-SL Versus Videolaryngoscopy in Expected Difficult Airway

VivaOP
Start date: August 27, 2020
Phase: N/A
Study type: Interventional

Patients requiring endotracheal intubation for elective surgery with an expected difficult airway are randomized to be intubated either by a) videolaryngoscopy or b) an endotracheal tube-mounted camera.

NCT ID: NCT04501666 Completed - Prurigo Nodularis Clinical Trials

An Efficacy and Safety Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis

Start date: September 11, 2020
Phase: Phase 3
Study type: Interventional

The primary objective is to assess the efficacy of nemolizumab (CD14152) compared to placebo in participants greater than or equal to (>=) 18 years of age with prurigo nodularis (PN) after a 16 week treatment period.

NCT ID: NCT04501107 Completed - Type 1 Diabetes Clinical Trials

A Trial to Compare BioChaperone Insulin Lispro Formulations With US Approved Humalog® and With EU Approved Humalog® in Patients With Type 1 Diabetes Mellitus

Start date: August 3, 2020
Phase: Phase 1
Study type: Interventional

This is a single-centre, randomised, double-blind, 4-way crossover, 4-treatment, euglycaemic clamp study in subjects with Type 1 Diabetes Mellitus (T1DM). Each subject will be randomly allocated to one of four treatment sequences. Each sequence comprises one single dose of each of four IMPs. IMP1 and IMP2 are BioChaperone lispro formulations. They have the same composition and correspond to different development stages of a unique product which is BioChaperone insulin lispro; between them, improvements were made to prepare industrial production. Comparators (IMP3 and IMP4) are US-approved Humalog® and EU-approved Humalog®. All IMPs will be dosed at 0.2 U/Kg of insulin lispro on 4 dosing visits separated by a washout period of 5 to 15 days. The trial will compare the characteristics of BioChaperone insulin lispro fully liquid (IMP2) formulation to US-approved Humalog and EU-approved Humalog.

NCT ID: NCT04498650 Completed - Clinical trials for Mild Cognitive Impairment Due to AD

A Study to Evaluate Safety and Tolerability of Different Doses and Efficacy of PQ912 in Subjects With MCI and Mild AD

VIVIAD
Start date: July 6, 2020
Phase: Phase 2
Study type: Interventional

This is a phase 2B multicenter, randomized, double-blind, placebo-controlled, parallel group dose finding study to evaluate the safety, tolerability and efficacy of PQ912, an inhibitor of the glutaminyl cyclase enzyme, in 250 subjects with mild cognitive impairment and mild dementia due to Alzheimer 's Disease.

NCT ID: NCT04497597 Completed - Clinical trials for Rheumatoid Arthritis (RA)

A Study of Oral Upadacitinib Tablets to Assess Treatment Patterns, Achievement of Treatment Targets and Maintenance of Response in Adult Participants With Moderate to Severe Rheumatoid Arthritis

UPHOLD
Start date: October 16, 2020
Phase:
Study type: Observational

Rheumatoid Arthritis (RA) is an inflammatory disease of the joints causing pain, stiffness, swelling and loss of joint function. Despite the range of treatment options for RA steadily increasing, many patients remain sub-optimally managed, with sustained clinical remission rarely achieved. This study will assess the treatment patterns, achievement of treatment targets and maintenance of response. Upadacitinib is a drug approved for the treatment of moderately to severely active rheumatoid arthritis. Adult participants with moderate to severe RA who have been prescribed upadacitinib by their physicians will be enrolled. Approximately, 1660 participants will be enrolled this study, worldwide. Participants will not receive Upadacitinib as part of this study, but will be followed for response to treatment for up to 24 months. There may be higher burden for participants in this trial compared to their standard of care. Participants will attend regular visits, every 3 months, during the course of the study at a hospital or clinic and will be asked to provide additional information by questionnaire at each visit.