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NCT ID: NCT03623919 Recruiting - Accidental Fall Clinical Trials

FallSensing Multiplayer Games for Fall Risk Prevention in Senior Care Centers

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

Fall prevention programs should include strength and balance training, home hazard assessment and intervention, vision assessment and referral and also medication review with modification/withdrawal. Evidence exists that a tailored exercise program can reduce falls by as much as 54%. The FallSensing games software include 3 mini-games to be played by two teams with up to 3 players each will compete against each other alternately. The players will perform an initial evaluation with FallSensing screening tool, 16 sessions of group games (2 times a week/8weeks) with FallSensing multiplayer games and a final evaluation also with FallSensing screening tool. Both initial and final evaluation include six functional tests (Grip Strength, Timed Up and Go, 30 seconds Sit-to-Stand, Step test, 4 Stage Balance test "modified" and 10 meters Walking Speed) and a questionnaire concerning self-efficacy for Exercise.

NCT ID: NCT03623724 Recruiting - Major Depression Clinical Trials

iCare4Depression: Effectiveness of a Blended Cognitive-Behavioral Therapy in Routine Practice

iCare4Dep
Start date: December 2, 2017
Phase: N/A
Study type: Interventional

The main objective of this research project is to implement and evaluate the clinical effectiveness and cost-effectiveness of a Blended Cognitive-Behavioral Therapy (bCBT) in routine practice, comparing it with Treatment as Usual (TAU). This research project includes a pilot study and a randomized clinical trial (RCT). The pilot study main objective is to adapt the bCBT based on Moodbuster, an internet-based treatment platform developed by the ICT4Depression Consortium (INESC-TEC, Vrije Universiteit and University of Limerick), to the Portuguese population. More specifically, this pilot study intends: (1) to detect problems and refine procedures, establishing a definitive Portuguese version of the blended treatment; (2) to assess clinical effectiveness (non-controlled), estimating effect sizes at the end of the treatment and follow-up; (3) to assess patients' satisfaction and personal views concerning their process of change; (4) to develop dynamic models of the individual trajectories during treatment based on Ecological Momentary Assessments. The pilot study will involve the participation of psychologists trained in bCBT and 20 participants diagnosed with Major Depression and willing to use the Moodbuster system. The RCT is composed by two arms (an experimental condition and a control condition) and it will be implemented in routine practice. In the experimental condition, the patients diagnosed with Major Depression will receive a treatment that integrates face-to-face cognitive-behavioral sessions with online sessions available through Moodbuster system (bCBT). In the control condition, patients diagnosed with Major Depression will receive TAU that consists in routine care that patients receive in primary care. The RCT will involve the participation of family doctors and psychologists working in routine practice. One-hundred patients will be recruited and randomized in the two conditions: 50 patients for bCBT condition and 50 patients for TAU condition. The main objectives are: (1) to assess the clinical effectiveness of bCBT and compare it with TAU in routine practice; (2) to estimate and compare cost-effectiveness of both treatments; (3) to assess patients' and clinicians' satisfaction with the bCBT and TAU; (4) to refine the previous models of individual trajectories and to assess differential effects on different patient clusters; (5) to establish guidelines for using bCBT within Portuguese routine practice services.

NCT ID: NCT03622593 Completed - Clinical trials for Diabetic Macular Edema

A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema

RHINE
Start date: October 9, 2018
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered at 8-week intervals or as specified in the protocol following treatment initiation, compared with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema (DME).

NCT ID: NCT03609047 Active, not recruiting - Clinical trials for Breast Cancer Stage II

Adjuvant Palbociclib in Elderly Patients With Breast Cancer

Appalaches
Start date: June 14, 2019
Phase: Phase 2
Study type: Interventional

Phase II study to assess the efficacy of the combination of at least 5 year endocrine therapy and 2 year-palbociclib as adjuvant systemic treatment instead of adjuvant chemotherapy followed by endocrine therapy in older patients with stage II-III ER+/HER2- early breast cancer.

NCT ID: NCT03607422 Active, not recruiting - Atopic Dermatitis Clinical Trials

A Study to Evaluate Upadacitinib in Adolescents and Adults With Moderate to Severe Atopic Dermatitis (Measure Up 2)

Start date: July 27, 2018
Phase: Phase 3
Study type: Interventional

The objective of this study is to assess the efficacy and safety of upadacitinib for the treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

NCT ID: NCT03605433 Not yet recruiting - Clinical trials for Coronary Artery Disease

Surgical Revascularization Outcomes After Oral Anticoagulation or Antiplatelets

SCOOP
Start date: December 1, 2018
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to evaluate whether treatment with oral anticoagulation or oral anticoagulation and aspirin is better than aspirin alone in cardiovascular outcomes and saphenous graft patency in patients submitted to coronary artery bypass graft.

NCT ID: NCT03604835 Recruiting - Clinical trials for Mucopolysaccharidosis VII

Mucopolysaccharidosis VII Disease Monitoring Program

Start date: January 29, 2018
Phase:
Study type: Observational

The objectives of this study are to characterize MPS VII disease presentation and progression and assess long-term effectiveness and safety, including hypersensitivity reactions and immunogenicity of vestronidase alfa.

NCT ID: NCT03600961 Terminated - Clinical trials for Ischemic Heart Disease

BIOFLOW-SV Portugal Registry

BIOFLOW-SV
Start date: July 5, 2018
Phase:
Study type: Observational

Assessment of the clinical safety and performance of the Orsiro drug-eluting stent in a real world setting in patients with small vessels with reference vessel diameter ≤2.75 mm

NCT ID: NCT03600883 Active, not recruiting - Clinical trials for KRAS p.G12C Mutant Advanced Solid Tumors

A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreaK 100)

Start date: August 27, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Evaluate the safety and tolerability of sotorasib in adult subjects with KRAS p.G12C mutant advanced solid tumors. Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects with KRAS p.G12C mutant advanced solid tumors.

NCT ID: NCT03600805 Terminated - Clinical trials for Giant Cell Arteritis

Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA

Start date: November 20, 2018
Phase: Phase 3
Study type: Interventional

Primary Objective: To evaluate the efficacy of sarilumab in participants with giant cell arteritis (GCA) as assessed by the proportion of participants with sustained remission for sarilumab compared to placebo, in combination with a corticosteroid (CS) tapering course. Secondary Objective: - To demonstrate the efficacy of sarilumab in participants with GCA compared to placebo, in combination with CS taper with regards to: - Clinical responses (such as responses based on disease remission rates, time to first disease flare) over time. - Cumulative CS (including prednisone) exposure. - To assess the safety (including immunogenicity) and tolerability of sarilumab in participants with GCA. - To measure sarilumab serum concentrations in participants with GCA. - To assess the effect of sarilumab on sparing glucocorticoid toxicity as measured by glucocorticoid toxicity index (GTI).