cyrilzakka/clinical-trials huggingface dataset:
ASDactive: An Integrated Theory-based Intervention to Promote Habitual Physical Activity

ASDactive is a theory-based behaviour change intervention aimed at improving the physical activity behaviours of autistic youth. The feasibility of the intervention will be tested through interviews with participants and stakeholders. "Proof of concept" will be tested through preliminary measures of physical activity measured before and after the intervention.

ASDactive is has been developed with guidance from autistic people and stakeholders in autism. It is informed by motivation and behaviour change theory, specifically habit theory. The intervention aims to improve the habitual exercise behaviours of autistic youth by focusing on their strengths and interests.

The feasibility study will run for 3-months, with a further 3-month follow-up period. Participants will attend motivational sessions in person where they will self-select physical activity habits to incorporate into their daily lives. They will be taught fundamental movement skills that they can use in their own leisure time. In-person sessions will be held once per fortnight with online sessions twice weekly. Participants will be encouraged to engage with as many sessions as possible, but part of the evaluation will assess uptake and engagement.

Self-determination theory and habit theory will underpin all aspects of the intervention and autistic strong interests will be embedded in the materials used.

Eligibility Criteria:
Inclusion Criteria:

* Young people aged 10-24-years diagnosed with Level 1 autism or Asperger's syndrome

Exclusion Criteria:

* Physical conditions or injuries that might hinder physical activity participation
A Randomized, Open-label, LOSARTAN Therapy on the Progression of Aortic Root Dilation in Patients With Marfan Syndrome

To assess the efficacy of angiotensin II receptor blocker, Losartan, to prevent progressive dilation of aortic root in patients with Marfan syndrome.

Marfan syndrome (MFS) is a multisystem connective tissue disorder of autosomal dominant inheritance1. The cardinal features are noted in the cardiovascular, ocular, and skeletal system. The most life-threatening complication of MFS is progressive aortic root dilation leading to aortic dissection or rupture. Losartan, an angiotensin II type I receptor (AT1) antagonist, is a drug already in clinical use for hypertension and type II diabetic nephropathy. A recent study showed that Losartan prevents aortic root dilation and lung problem in a mouse model of MFS. Therefore, the goals of this clinical trial are to examine the efficacy and safety of Losartan in patients with Marfan syndrome for aortic root dilation prevention.

Eligibility Criteria:
Inclusion criteria

* Marfan syndrome with recognized aortic root dilation
* Patients must be older than one year of age
* Beta-blocker treatment at least three months
* Must sign an informed consent form

Exclusion criteria

* Prior to aortic root surgery
* Aortic root dimension more than 5.5cm
* Aortic surgery within 6 months
* Diabetes mellitus or liver and renal dysfunction or asthma
* Pregnancy
* Intolerance to Losartan therapy
A Dose Ranging Study Of GW640385 Boosted With Ritonavir (Rtv) In Comparison To A RTV-Boosted Protease Inhibitor (PI) In HIV-1 Infected PI-Experienced Adults

This is a two phase study (randomised and non-randomised phase). The randomised phase will initially examine 4 blinded doses of GW640385 boosted with rtv (with continuation of current background therapy) in comparison to an ongoing, open-labeled rtv-boosted protease inhibitor (PI) regimen for 15 days. At the Day 15 visit, all subjects will optimize background therapy. Additionally, subjects receiving the lowest dose of GW640385 will be re-randomised to one of the higher doses and subjects in the control arm will receive a new rtv-boosted PI based on resistance testing at screening. Subjects will remain in the randomized phase on one of these 4 continuing treatment arms for at least 48 weeks. An interim analysis will occur during the randomised phase to select for a dose of GW640385 to evaluate further in Phase III studies. After dose selection subjects will move to the non-randomised phase of the study. In the non-randomised phase subjects who are receiving GW640385 will be assigned to final selected dose for assessment of long term safety, tolerability, pharmacokinetics, and antiviral activity.

A Phase IIB, Randomized, Multicenter, Parallel Group Study to Evaluate the Short-Term Safety, PK and Antiviral Activity of Four Dosing Regimens of GW640385/rtv Therapy Compared to Open-label Current Protease Inhibitor (PI) Therapy in HIV-1, PI-Experienced Adults for 2 wks with Long-Term Evaluation (\>48 wks) of Safety, PK and Antiviral Activity of Selected GW640385/rtv Dosing Regimen(s) vs. a RTV-boosted, PI Containing Regimen

Eligibility Criteria:
Inclusion criteria:

* 18+ years of age (or =16 years of age for non-EU countries, according to local requirements).
* HIV-1 infected subjects.
* Females must be of either non-childbearing potential or have a negative pregnancy test at Screening and agree to use a protocol approved method of contraception.
* Plasma HIV-1 RNA (viral load) =1,000 copies/mL at Screening.
* Evidence of at least 2 multi-PI resistant mutations at Screening or within 3 months of Screening.
* Subjects must have been receiving the same anti-HIV medicines that they are on currently for at least 8 weeks prior to Screening; these anti-HIV medicines will include a single protease inhibitor (PI) in combination with a low dose of ritonavir (i.e., a ritonavir-boosted PI). However, the current PI cannot be tipranavir.
* Able to understand and follow protocol requirements, instructions and protocol-stated restrictions.
* Be willing and able to provide signed and dated written informed consent prior to study entry.

Exclusion criteria:

* Subjects cannot change their anti-HIV medicines between Screening and Day 1 Visit.
* Subjects can not be receiving dual ritonavir-boosted PIs, non-nucleoside reverse transcriptase inhibitors (NNRTIs) or Tipranavir at Screening.
* Active CDC Class C disease at screening.
* Pregnant or breastfeeding women.
* Protocol-specified laboratory abnormalities at Screening.
Mifepristone Dynamic Testing for Diagnosis for Central Adrenal Insufficiency

The researchers propose the use of mifepristone as an alternative way to test for Central Adrenal Insufficiency (CAI). They want to assess the feasibility of recruitment and the efficacy of the purposed method.

Recruitment for this trial was legally opened on February 17, 2020. When the record was first released, it incorrectly listed the recruitment status as "Not Yet Recruiting." This mistake was noticed before the first participant actually enrolled, May 5, 2021. The decision to terminate for low recruitment was made on Sept 7, 2022, approximately 30 months later, as at that point it was deemed impossible to reach the initial enrollment target of 26.

Eligibility Criteria:
Inclusion Criteria (1 of the following):

* Completed insulin tolerance testing (ITT) at University of Michigan from 2012 to present.
* Are scheduled to complete ITT.
* Are clinically suspected to have adrenal insufficiency but have not undergone ITT.

Exclusion Criteria:

* Female patients who are of child-bearing potential (defined as a sexually mature woman who has not undergone hysterectomy, bilateral oophorectomy bilateral salpingectomy or bilateral tubal ligation/occlusion, at least 12 weeks prior to screening, or who has not been naturally postmenopausal for at least 24 consecutive months prior to study enrollment) and not using non-hormonal contraception.
* Female patients not willing to use non-hormonal contraception for one month following treatment.
* Women who are pregnant or breast feeding.
* Patients with an existing diagnosis of adrenal insufficiency who are on any glucocorticoid replacement other than oral hydrocortisone or prednisone.
* Patients on medications that are strong CYP3A
* Patients taking other medications metabolized by CYP3A
* Patients who have a history of QT prolongation and patients with any recent abnormal electrocardiogram (ECG).
Testing the Effectiveness of a Falls Prevention System

The purpose of this single arm intervention study is to determine if the fall rate (as measured by falls per 1000 patient days) for patients designated "high fall risk" decreases with the use of the PUP™ \[Patient is UP Falls Prevention System\] when compared to the historical falls rate data for the prior 12 months from those same nursing units within the OSUWM Brain \& Spine Hospital.

The purpose of this single arm intervention study is to determine if the fall rate (as measured by falls per 1000 patient days) for patients designated "high fall risk" decreases with the use of the PUP™ \[Patient is UP Falls Prevention System\] when compared to the historical falls rate data for the prior 12 months from those same nursing units within the OSUWM Brain \& Spine Hospital. All Brain and Spine Hospital patients will be evaluated as to fall risk using the current fall risk assessment tool employed by OSU Medical Center and administered in the usual and customary fashion upon evaluation on the floor and Pod. Patients who are determined to be at a high fall risk will be approached to participate. Those patients who consent to participate in the study will remain in the study until a nurse removes the patient from high risk fall status or the participant has been discharged from the hospital. Any patient fall will to be reported and evaluated following current processes and procedures developed by the OSU Brain and Spine Institute as maintained with IHIS; the PUP™ as the intervention for this study will be an adjunct to those fall prevention processes already in place.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years of age or older;
* All high-risk fall patients, eighteen years of age or older, who are admitted to the OSU Brain and Spine Hospital on Floors 8 South, 9 South, 10 South, 8 East, 9 East or 10 East. Patients will undergo a pre-assessment as per OSUWMC procedure to determine if they are a high-fall risk.

Exclusion Criteria:

* Patients whose medical condition as assessed by the PI prohibits their participation in the program, which would include among others the following: patients who lack the capacity to consent, patients with an anatomy or wound issue on their feet or around their calves that would bar them from wearing socks on either foot, and/or patients for whom the sock would impede medical treatment.
The Effects of Midazolam on the Quality of Postoperative Recovery

The purpose of this study is to determine whether Midazolam given pre-operatively to patients undergoing abdominal surgery improves the quality of recovery.


Eligibility Criteria:
Inclusion Criteria:

* All patiënts operated with a laparotomy in the Erasmus Medical Center of Rotterdam, older than 18 years and planned for a postoperative stay for a minimum of 3 days

Exclusion Criteria:

* Pregnant, benzodiazepine usage, contra-indication for midazolam, mental retardation, non-dutch speaking patients
Mobile Health Application for Diabetes

Creation of a mobile health application for individuals with type II diabetes. This application was designed to improve knowledge, self-efficacy and self-care. The application delivered educational material and provided push notifications (messages). It also allowed for the participants to key in blood glucose levels, carbohydrate consumption and daily exercise.

capABILITY (the mobile health application) was designed to cover three main diabetes content areas which the investigators call modules: diet (module 1), exercise (module 2) and self-management (module 3) (i.e. medication adherence, glucose monitoring). The length of the study was 9 weeks in duration with three weeks of content per module. Within each module new material was delivered each week through capABILITY. Essentially, every Monday started a new week's worth of educational material that was intended to last until Sunday. Each participant was randomly assigned to either the control group (no triggers), spark trigger group or facilitator trigger group. At the beginning of each module the participants would be randomly assigned to one of the three aforementioned classification groups (this was a 2-Factor Cross-Over Design).

The investigators utilized the Perceived Diabetes Self-Efficacy Scale , Diabetes Knowledge Test developed by Michigan University, and the Summary of Diabetes Self-Care Activities Measures scale (SDSCA) . All the participants completed the perceived diabetes self-efficacy scale along with the knowledge test and SDSCA Pre/Post intervention. In addition, the participants answered one self-efficacy, knowledge, self-care and goal question at the conclusion of each week within capABILITY.

Eligibility Criteria:
Inclusion Criteria:

* Must be at least 21 years of age or older
* Current diagnosis of type II diabetes
* Must have access to a smartphone and daily internet (WiFi)

Exclusion Criteria:

* Anyone with gestational diabetes
Phase 1b/2 Study of AMG 655 With mFOLFOX6 and Bevacizumab for First-Line Metastatic Colorectal Cancer

This phase 1/2, multi-center, randomized, double-blind, placebo-controlled trial is designed to evaluate the efficacy and safety of AMG 655 when combined with mFOLFOX6 and bevacizumab compared with mFOLFOX6 and bevacizumab alone in subjects with previously untreated metastatic colorectal cancer (CRC).

The clinical benefit of AMG 655 in combination with mFOLFOX6 and bevacizumab will be measured by progression-free survival, objective response rate, time to response, duration of response, and overall survival. This study is also designed to evaluate the safety and tolerability of AMG 655 in combination with mFOLFOX6 and bevacizumab and to evaluate anti-AMG 655 antibody formation and the pharmacokinetics of AMG 655.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum.
* Subjects with measurable or unmeasurable disease
* Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
* Men or women at least 18 years of age
* Adequate hematologic, renal, hepatic and coagulation function

Exclusion Criteria:

* History or known presence of central nervous system (CNS) metastases
* Prior chemotherapy or other systemic therapy for advanced or metastatic CRC
* Any investigational agent or therapy for advanced or metastatic CRC
* Clinically significant cardiac disease
* Clinically significant peripheral neuropathy
* Active inflammatory bowel disease
* Recent gastrointestinal ulcer or hemorrhage
* Recent arterial thrombotic event or pulmonary embolus
* Recent history of clinically significant bleeding, bleeding diathesis, or coagulopathy
* Recent major surgical procedure or not yet recovered from major surgery
A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC)

This is a phase 2/3, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in combination in participants with unresectable, advanced or metastatic NSCLC determined to harbor oncogenic somatic mutations or positive by tumor mutational burden (TMB) assay as identified by a blood-based next-generation sequencing (NGS) circulating tumor DNA (ctDNA) assay.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of unresectable Stage IIIb not amenable to treatment with combined modality chemoradiation (advanced) or Stage IV (metastatic) NSCLC
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
* Measurable disease
* Adequate recovery from most recent systemic or local treatment for cancer
* Adequate organ function
* Life expectancy greater than or equal to (\>/=) 12 weeks
* For female participants of childbearing potential and male participants, willingness to use acceptable methods of contraception

Exclusion Criteria:

* Inability to swallow oral medication
* Women who are pregnant or lactating
* Symptomatic, untreated CNS metastases
* History of malignancy other than NSCLC within 5 years prior to screening with the exception of malignancies with negligible risk of metastasis or death
* Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction, or cerebrovascular accident within 3 months prior to randomization, unstable arrhythmias, or unstable angina
* Known active or uncontrolled human immunodeficiency virus (HIV) infection
* Either a concurrent condition or history of a prior condition that places the patient at unacceptable risk if he/she were treated with the study drug or confounds the ability to interpret data from the study
* Inability to comply with other requirements of the protocol
Continuous and Discontinuous Determination of Propofol Concentration in Breathing Gas

This study should compare the propofol concentration in breathing gas and in plasma (before and) after lung passage. Propofol concentrations in breathing gas are continuously measured by a sensor. For comparison a discontinuous method is used. Neurophysiologic parameters for determination of depth of anesthesia are compared to the continuous measured propofol concentration in breathing gas.

Study hypothesis: continuous measured propofol concentration in breathing gas correlates to propofol concentration in plasma and depth of anaesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Patient destined for general anesthesia

Exclusion Criteria:

* Heart insufficiency NYHA IV
* Allergy to propofol
Type One Diabetes and Low Carb Study

The investigators have identified a support group on social media with \~1500 members (children and adults), the majority of whom have T1DM and follow a carbohydrate-restricted diet. Many participants report exceptionally low HbA1C and insulin requirements. If these anecdotal reports are reflective of a large group of people with type 1 diabetes, a clinical trial would be warranted.

The investigators propose to survey the above-mentioned group and their professional diabetes care providers to characterize glycemic control and explore associated dietary and diabetes care factors.

The surveys will address questions in the following domains: 1) Diabetes diagnosis and treatment; 2) Carbohydrate-restricted diet; 3) Insulin regimen; 4) Other diabetes related care; 5) Diabetes complications; 6) Other related health and healthcare; 7) Patient provider interactions; 8) Socio-demographics. Drafts of these surveys are included in the appendix of this protocol.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with a diagnosis of T1DM who are currently on insulin treatment or
* Adults who are a parent or guardian of a child with T1DM who is currently on insulin treatment and
* Self-reported use of a regimen including carbohydrate restriction for at least 3 months

Exclusion Criteria:

* Women who are pregnant or breastfeeding.
Coronary Artery Disease Management Using Multislice Computed Tomography and Magnetic Resonance Imaging

The primary objective of this study is to analyze the clinical value of a therapeutic management strategy based on the results of coronary CT angiography and functional MRI. The clinical value of CT and MRI will be analyzed in patients with suspected coronary artery disease.


Eligibility Criteria:
Inclusion Criteria:

* Suspected coronary artery disease and planned conventional coronary angiography based on atypical angina pectoris

Exclusion Criteria:

* Known coronary artery disease
* ST elevation
* Age below 30 years
* Women of child-bearing potential without a negative pregnancy test
* Inclusion in another study
* Heart rate above 70 beats per min and contraindications to beta blockers
* Atrial fibrillation or uncontrolled tachyarrhythmia, or advanced atrioventricular block
* Inability to hold the breath for 10 s
Skin Dressings Versus Lubrication to Prevent Pressure Ulcers: A Randomized Trial

Study purpose:

To assess if - in adult patients admitted to hospital with surgical or medical conditions at high/very high risk of developing pressure ulcers (PU) according to Braden scale - using skin dressing protection versus conventional care (lubricant or moisturizer cream) may prevent the incidence of in-hospital PU

Participants will receive, in addition to the experimental/control interventions, background skin care measures, including anti- bedsore mattresses; body position changes every two hours, and shear/friction reduction.

Trained nurses will review all participants' charts and verify any report of PU until the first ambulation, discharge or death. Patients with a verified PU are referred to the institutional wound care group.

For the purpose of outcome adjudication, study personnel will email digital pictures to 2 independent, blinded outcome assessors (experts in skin care). Skin lesions will be rated in 4-level scale (EPUAP/NPUAP). In case of disagreement, a single, independent referee will confirm the presence/absence of any potential PU.

The unit for analysis will be patients developing (first occurrence, in a time-to-event analysis) PUs in the areas covered by the interventions.

See further details on eligibility, interventions and study outcomes below

Eligibility Criteria:
Inpatients will be eligible if meeting two criteria:

* Intact skin on hospital admission
* High/very high risk of PU (Braden´s scale ≤ 20 points) will be eligible.

Exclusion Criteria:

* Treating physician disagree with participation
* Need for chronic use of diapers