cyrilzakka/clinical-trials huggingface dataset:
Enhancing Exercise Participation in Overweight Adults

The purpose of this study is to examine whether behavioral strategies implemented during the adoption versus the maintenance periods of weight loss to enhance exercise participation in overweight adults are more effective than a standard behavioral intervention.


Eligibility Criteria:
Inclusion Criteria:

1. Female or Male
2. 18-55 years of age
3. BMI = 25-39.9 kg/m2
4. Ability to provide informed consent.
5. Ability to provide consent from their personal physician to participate in this study.

Exclusion Criteria:

1. Reporting regular exercise participation of at least 20 minutes per day on at least 3 days per week during the previous six months. (This study is designed to recruit relatively sedentary adults.)
2. Diabetes, hypothyroidism, or other medical conditions which would affect energy metabolism.
3. Women who are currently pregnant, pregnant within the previous six months, or planning on becoming pregnant within the next 18 months. (Pregnancy during initial screening will be based on self-report and will be included on the detailed medical history that is completed by subjects)
4. Non-medicated resting systolic blood pressure \>160 mmHg or non-medicated resting diastolic blood pressure \>100 mmHg, or taking medication that would affect blood pressure.
5. Taking medication that would affect resting heart rate or the heart rate response during exercise (e.g., beta blockade).
6. Arrhythmia on resting or exercise electrocardiogram that would indicate that vigorous exercise was contraindicated.
7. History of myocardial infarction or valvular disease.
8. Weight loss of \>5% of body weight within the previous 12 months.
9. History of orthopedic complications that would prevent optimal participation in the exercise component (e.g., heel spurs, severe arthritis).
Immediate Implant Placement in the Molar Regions

The purpose of this study is to look at the bonehealing when a molar has been extracted and immediately replaced by an implant leaving some defects around the implant.

The defects are being treated in three different with the hypothesis that the three ways of treatment result in equal bonehealing.

This study is a randomized clinically controlled study with three group of each thirty patients, where the bonehealing after immediate implantplacement in molarregions is being investigated.

Totally 90 patients are going to get a molar tooth extracted and immediately replaced with an implant (Brånemark System, Wide Platform). The molar tooth should be in such a condition that is has to be extracted.

Extracting a molar leaves a defect which cannot completely be filled out by an implant. The 90 patients are therefore randomised into 3 groups according to how the perimarginal bonedefects around the placed implants are being treated: 1. Bonechips 2. Membrane 3. Bonechips+Membrane. The bonehealing of the defects around the implants are then compared the groups in between. The amount of newly formed bone is being estimated too by digital radiography and subtractionradiography. Furthermore the prognosis for immediate placed implants in molar regions in relation to the method of defectreconstruction one year after crown delivery is also being investigated. All the investigations are conducted with the Ho-hypothesis that there is no difference in the bonehealing the three groups in between.

Eligibility Criteria:
Inclusion Criteria:

* A molar tooth which has to be extracted
* Healthy persons with only mild systemic disease with no functional limitation

Exclusion Criteria:

* Pregnant
* Any disease that is influencing the turnover of bone or oral mucosa
Testing an Evidence-Based Supported Employment Model in Autistic Young Adults

This study aims to enhance employment outcomes for young adults with autism and intellectual and developmental disabilities (IDD) through the implementation of an evidence-based supported employment model known as Individual Placement and Support for Autism (IPS-AUT). The study will evaluate the feasibility, acceptability, and effectiveness of IPS-AUT in promoting Competitive Integrated Employment (CIE). The trial will involve partnerships with supported employment agencies, training providers in IPS-AUT, and assessing employment outcomes and implementation factors. The ultimate goal is to create a scalable, evidence-based employment support model for individuals with autism.

This study builds on prior research and pilot testing of IPS in the autism and IDD community by implementing a 12-month Hybrid Type 1 trial to evaluate the effectiveness and implementation of IPS-AUT. The current study will include three primary aims:

Consumer Support Toolbox Development: Using data from previous focus groups, researchers will develop and test a Consumer Support Toolbox (CST) to align IPS services with autistic consumer needs.

IPS-AUT Implementation and Outcomes Evaluation: A 12-month Hybrid Type 1 trial will assess feasibility, acceptability, fidelity to IPS standards, and employment outcomes. The study aims for a minimum 50% success rate in Competitive Integrated Employment and at least 75% feasibility and acceptability.

Mediators of Employment Outcomes: Researchers will explore the role of parent/carer engagement and work-related social cognition in improving employment success.

This trial is designed to prepare for a larger R01-funded study by refining implementation strategies and addressing key barriers. Participants will include young adults with autism, their employment providers, and caregivers, with data collected through surveys, focus groups, interviews, and standardized assessments. The study is funded by the National Institute of Mental Health and conducted in collaboration with supported employment agencies in California.

Eligibility Criteria:
Inclusion Criteria: California supported employment agency clients meeting the following criteria:

* Community diagnosis of autism spectrum disorder, demonstrated by a letter from a healthcare provider, psychologist, other mental health professional, Regional Center representative, or school psychologist.
* Aged 21-40 years.
* Minimum 4th-grade reading level (approximately mild ID).
* Not currently employed but seeking employment.

Exclusion Criteria:

- Not interested in employment.
Predicting Response to Vedolizumab in Pediatric Inflammatory Bowel Diseases

Vedolizumab (VDZ) is a humanized immunoglobulin G1 monoclonal antibody acting against α4β7 integrin which modulates lymphocyte trafficking in the gut.

Results from the adult GEMINI-1 and GEMINI-2 trials demonstrated clinical efficacy in induction and maintenance of remission in both ulcerative colitis (UC) and Crohn's disease (CD), respectively.

Recent real life cohorts in adults support the effectiveness of VDZ in inducing and maintaining remission, both in CD and UC. In pediatrics, there are very limited data on the use of VDZ besides two retrospective case series.

Data on immunogenicity and therapeutic drug monitoring (TDM) of VDZ is conflicting in adults and practically non-existent in children.

The investigators aim to prospectively explore the real life short and longer term outcomes of VDZ in pediatric IBD (including growth) and to develop a prediction model for treatment success based on VDZ trough levels and other clinical and laboratory variables.

This is a multi-center prospective cohort study in which the investigators are aim to enroll 140 children under the age of 18 years, diagnosed with CD, inflammatory bowel disease unclassified (IBDU) or UC (approximately 70 in UC/IBDU and 70 in the CD group) who commenced on Vedolizumab for any reason at the discretion of the treating physician.

Patients will be followed up to 3 years at 8 different time points: week 0, week 2, week 6, week 14, week 30, week 54 (1 year), week 108 (2 years) and week 162 (3 years). Blood work will be collected at each visit during the time of venous access insertion for the drug infusion for serum and stool sample will be collected at visits 0, 14, 30, and 54. In addition, at week 0 and 14 whole blood will be collected into a PaxGene tube for gene expression analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Children under the age of 18 years.
2. IBD Diagnosis
3. Initiating Vedolizumab therapy

Exclusion Criteria:

1. Starting Vedolizumab to prevent post operative recurrence
Neuromuscular Electrical Stimulation on Patellofemoral Pain

Objective this study is to analyze the effects of an intervention protocol with neuromuscular electrical stimulation in the vastus medialis obliquus and gluteus medius (GM) associated with exercises on electromyographic activity, muscle performance, self-reported functionality and pain of women with patellofemoral pain.

This is a randomized, blinded trial in which 40 women, aged 18-30 years, will be randomized into 2 groups: Stimulation and Exercise Group (SEG) - will perform an exercise protocol associated with stimulation in the vastus medialis (VM) and gluteus medius (GM) muscles. Exercises Group (ExG) - will perform the same protocol of exercises of the previous group, however, without association with neuromuscular electrical stimulation. The intervention will occur twice a week for eight weeks. All volunteers will be submitted to the evaluation of the electromyographic activity of the VM, the GM and the vastus lateralis, the dynamometric parameters, the intensity of the pain and the functionality, in four moments: 72h hours before the beginning of the intervention; after 4 weeks of intervention; after 8 weeks of intervention; after 16 weeks from the start of the intervention (eight weeks after the end of the protocol). In this way, the investigators will investigate the applicability of the proposed trial with the use of neuromuscular electrical stimulation and identify the effects of this resource in the treatment of PFP.

Eligibility Criteria:
Inclusion Criteria:

* Present anterior or retropatellar pain during at least two of the following functional activities: sitting for long periods, going up or down stairs, running, kneeling down, crouching or jumping;
* A minimum pain score of three on the numerical pain scale, at the last 24 hours, with insidious and non-traumatic onset of symptoms for at least one month.

Exclusion Criteria:

* History of surgery, trauma or an osteomioarticular system injury in the lower limbs in the last six months;
* Other pathology associated with the knee joint and could not have performed physical therapy treatment in the last twelve weeks;
* Body mass index greater than 30;
* Pregnancy or breastfeeding;
* Contraindications for the application of neuromuscular electrical stimulation;
* Intolerance or non-acceptance of electric current;
* Missing more than two intervention sessions.
VEGF and SFlt-1 Levels in the Pathogenesis and Severity of COVID-19 Disease

To assess blood levels of vasoactive mediators that may regulate pulmonary endothelial permeability and contribute to multi-organ injury in patients with COVID-19 disease and to correlate the levels of these mediators with disease outcomes such as ICU admission, length of ventilatory support, respiratory failure, kidney failure, heart failure, and death.

When patients are sick with other lung infections (pneumonias) caused by viruses or bacteria there are changes in a pathway that regulates the "leakiness" the tiny airspaces inside the lungs. Even bigger changes in this pathway are seen when patients develop severe breathing difficulties (acute respiratory distress syndrome) similar to what is seen in patients who get really sick with COVID-19 disease.

There are important changes in this pathway that occur in patients who have preexisting cardiovascular (heart) disease who do not have lung infections. The investigator will evaluate these levels in patients with COVID-19 because the investigator believes that this baseline difference in pathway regulation may be one reason patients with heart disease who contract COVID-19 get sicker than patients without heart or vascular disease.

The investigator will also assess the levels of components of this pathway in patients who are less sick with those who became sick enough to require a tube to help them breathe because this is important to determine if COVID-19 lung disease has a similar effect on this pathway as other lung infections like flu and bacterial pneumonias.

Eligibility Criteria:
Inclusion Criteria:

* Positive test for COVID-19 (SARS-CoV-2 infection)
* \>=18 years
* Blood (plasma) specimen(s) available in the CCTS biorepository

Exclusion Criteria:

* \<18 years
* Lack of blood specimen
The Investigator Administers Intracoronary Adrenaline Via the Catheter in STEMI Patients During Primary PCI, After Flow Restoration and Before Stenting, and Studies Its Effect in Prevention of No Reflow

The aim of this work is to study the role of intracoronary adrenaline administration as a preventive tool for no reflow in patients undergoing primary PCI.

The main question it aims to answer is:

Do prohylcatic intrcoronary adrenaline reduce the incidence of no reflow without increaing risk of arrhythmia in primary PCI?

The procedure will be performed by expert operators. All patients will receive the guidelines-directed recommendations of intervention of STEMI patients.

Study group wil receive Intracoronary 10 mcg adrenaline via the guiding catheter after restoration of epicardial coronary flow of the culprit vessel and achievement of TIMI I flow either after wiring and/or passage of a deflated balloon and/or PTCA with a small balloon, and/or use of thrombus aspiration and before stenting.

All steps in the Cath-lab will be described in detail:

The primary end points will be improvement in coronary flow, as assessed by TIMI (Thrombolysis in Myocardial Infarction) flow, and myocardial blush.

Secondary end points will be in-hospital mortality and major adverse cardiac events.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who are 18 years or older
2. Patients presenting with acute coronary syndrome with ECG criteria diagnostic of STEMI (according to the universal definition of myocardial infarction) within 12 hours from the onset of symptoms and treated by successful primary PCI.

Exclusion Criteria:

1. Age \< 18 years
2. Pregnant females.
3. Patients refused to give consent.
4. Patients who had normal coronary angiography.
5. Patients who had CTO lesions.
6. Patients who have SCAD.
7. Patients who developed dissection or mechanical complication during the procedure.
8. Patients presenting with cardiogenic shock.
9. Cardiomyopathies
10. Contraindications to epinephrine as HTN with SBP \>180 mmHg or DBP\>110 mmHg, clinically significant arrhythmia (Atrial fibrillation with rapid ventricular rate, ventricular tachycardia, or ventricular fibrillation) prior to PCI, known allergy to epinephrine.
Negative Pressure Drainage System Split-thickness Skin Graft Recipient Sites

To compare the efficacy and safety of negative pressure drainage system with controls (indirect saline soaks) in the coverage of recipient site wounds of split-thickness skin graft.

Randomized, comparator-controlled trial in patients underwent split-thickness skin graft conducted in Taipei Veterans General Hospital between Aug. 2012 and Dec. 2013. (No.) patients age 21 to 60 years were randomly assigned in the intervention group (n= ) of negative pressure drainage system or to a control group (n= ) of traditional method. Patients who had immunologic disease, end-stage renal disease, coagulopathy, or history of radiation were excluded. The conditions of graft take and pain and discomfort were compared every day during the first 7 days after operation and 2 weeks and 3 months follow up.

Eligibility Criteria:
Inclusion Criteria:

* Aged 21 to 60 years
* The wounds located on limbs or trunk
* The area of wounds is ranged 50 to 250cm2.

Exclusion Criteria:

* immunodeficiency disease
* end stage renal disease
* coagulopathy
* history of radiation to the recipient site
* allergy to the dressing
* major medical problems
World Digital Detox Program for Enhancing Youth and Family Well-being

The pervasive presence of digital devices and technology has reshaped contemporary society, providing numerous benefits but also prompting concerns about prolonged screen time, particularly with smartphones and social media. These concerns extend to their impact on interpersonal relationships and mental well-being. The Zep Foundation's World Digital Detox Program to address the challenges posed by excessive screen exposure, social media usage, and digital screen dependency.

This study aimed to assess the efficacy of the digital detox family intervention, endorsed by the World Digital Detox Day program, in curbing the use of digital devices-specifically smartphones and social media-and enhancing the overall well-being of youth and families.


Eligibility Criteria:
Inclusion Criteria:

for Caregivers:

* Age 18 or older at baseline assessment;
* Primary caregiver responsible for the care of an adolescent 10-14 who is a resident in the same household
* Able to speak English
* Agreement to participate in the program;
* Consent for self and child to participate in the study.

for Adolescents:

* Age 10-14 at baseline assessment;
* Agreed to participate in the study;
* Caregiver consent to participate in the study.

Exclusion Criteria:

* Serious Medical Conditions requiring frequent hospitalization
* Special Educational Need Children and Adolescents
* Substance abuse
Validation of a SOFMER Activity Scale

A person's dependency is defined as the total or partial inability to perform without helps the necessary activities of daily life due to activity limitations in the usual environment. The consequence is a restriction of participation. In physical and Rehabilitation Medicine (PRM), dependency impacts the healthcare team activity at several levels: patient's referral and care plan, conditions of home return and resumption of course of life, burden of care assessment and care teams management...

The main goal of this project is the validation of a score assessing physical and cognitive activities of patients in follow-up care and rehabilitation (FRC) departments based on the ICF model (International Classification of Functioning, Disability and Health) : the SOFMER Activity Scale (SAS).

We want to propose a French generic scale allowing quantifying precisely the dependence and burden of care of patients in FRC departments. This scale needs to be valid, easy to apply, easy to learn, reproducible, sensitive to change and common to adult subjects, children and elderly.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 2 years old
* Hospitalized in the participating department for at least 4 days
* For the responsiveness study : patients hospitalized in the FRC departments for obesity, spinal cord injuries, post-stroke rehabilitation or cardiorespiratory rehabilitation after cardiac surgery

Exclusion Criteria:

* Non-recipient of French Social Security
Trans-aortic Valve Replacement and Renal Infarction

Kidney Magnetic Resonance assessment before and after undergoing transcatheter aortic valve replacement

Each patient will undergo Magnetic Resonance assessment of the kidneys before the TAVR. on the third to 7th day after the ATVR, a second MRI to the kidneys will be performed. we will assess the changes and new lesions between both MRI tests and will perform a qualitative and quantitative measurement.

Eligibility Criteria:
Inclusion Criteria:

* Severe symptomatic aortic stenosis
* Patient is able to lay down supine for 20 min (the time needed to perform the MRI) without any difficulties.

Exclusion Criteria:

* Patient is on chronic renal replacement therapy (Dialysis)
* Documented Thrombus in the left ventricle or left atria
BioDulse II: The Effect of an Irish Seaweed Protein Extract on Glucose Control in Adults With Type 2 Diabetes

Co-ingesting protein with carbohydrate is an effective way to improve postprandial glucose handling. The investigators have isolated and identified a bioactive protein extracted from seaweed. The investigators aim to explore how varying doses of seaweed protein influence postprandial glycaemia and insulinaemia in a population with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-67

Exclusion Criteria:

* Terminal disease
* Exclusively receiving enteral or parenteral nutrition
* Any conditions/anomalies that are contraindications to bioelectrical impedance analysis as per institutional risk assessment and standard operating procedures
* Past medical history of cancer, neurological, kidney, pulmonary, digestive (Coeliac disease), thyroidal disease, cognitive impairment
Evaluation of Core Body Temperature When Using Forced Air Warming or an Active Blanket to Prevent Perioperative Hypothermia

This investigation is undertaken to investigate if patient warming with BARRIER® EasyWarm active self-warming blanket differs compared to active warming with forced air warming in terms of core body temperature perioperatively.

A non-inferiority, prospective, open-labelled, randomized, parallel investigation.

Randomized subjects will receive active warming with BARRIER® EasyWarm or with forced air warming. All subjects may receive rescue warming if their core temperature falls below 35.5°C. Rescue warming is optional and defined as the institution's standard of care to prevent hypothermia.

The primary purpose is to investigate if there is a clinically relevant difference in core body temperature between the two treatment groups.

A total of 60 subjects will be included in the investigation, i.e. 30 subjects in each treatment group. The number includes a 30% drop-out rate.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent i.e. subject must be able to understand and sign the Informed Consent Form (ICF)
* Male and female subjects aged 18 years and over
* Subject scheduled for surgery with a minimum length of 60 minutes and a maximum length of 120 minutes
* Scheduled surgery must be performed entirely under general anaesthesia
* The subject must be able to receive temperature assessments via an oesophageal temperature probe when under general anaesthesia and via an oral thermometer before and after general anaesthesia as well as in the pre- and post-op area
* The subject must have an oral temperature measurement of at least 36.0°C when first measured in the preoperative setting
* The subject's scheduled surgical procedure must allow time to be warmed with a fully activated BARRIER® EasyWarm at least 30 minutes prior to induction of general anaesthesia

Exclusion Criteria:

* Subjects with an American Society of Anesthesiologists (ASA) rating of 4 or greater
* Known Diabetes with an HbA1c of more than 6 %
* Relevant medical history (e.g., neuropathy, peripheral vascular disease, circulatory disorder or other) that presents risk to/of:

  1. The subject's normal temperature regulation or
  2. Perception of external temperature or
  3. Subcutaneous lipoatrophy
* Current use of concomitant medications that present relevant risk to/of:

  1. The subject's normal temperature regulation or
  2. Perception of external temperature or
  3. Subcutaneous lipoatrophy
* Epidural/Spinal anaesthesia
* An oral temperature measurement ≥ 37.5°
* Contraindications to the oesophagus temperature probe and oral thermometer
* Presence of skin and soft tissue disorders in areas covered directly by the device in the two treatment groups (e.g. pressure ulcers, clinically significant psoriasis, dermatitis or any other interruption of skin integrity that would be affected by direct heat)
* Pregnancy
* Severe non-compliance to protocol as judged by the investigator and/or Mölnlycke Health Care