cyrilzakka/clinical-trials huggingface dataset:
Early or Late Booster for Basic Life Support?

Attrition of skills after basic life support (BLS) training is common. Psychology studies have established that for basic memory recall tasks, spaced learning strategies improve retention. Spaced learning is often organized as a refresher or 'booster' course after initial training. This study aims to investigate if this principle holds true for BLS skills, which require rapid memory recall and efficient deployment of procedural skills while under time pressure.

Novice laypeople who have not received BLS training in the 6 months leading up to the date of participation will be recruited from the University of Ottawa and the general public. Participants will be randomized into one of three groups: early booster, late booster, or no booster (control). Currently, no booster is the educational standard. The early booster group will receive a booster at 3 weeks, the late booster at 2 months, and no booster for the control. All participants will undergo BLS training, an immediate post-test, and a retention post-test at 4 months. Post-tests involve a simulated cardiac arrest scenario. Raters will be blinded to the group allocation and simulation test order.

Eligibility Criteria:
Inclusion Criteria:

* Laypeople who have not received any BLS training or practice in the 6 months leading up to the date of their participation will be recruited.

Exclusion Criteria:

* Under 18 years old;
* Non layperson and Basic Life Training in less than 6 months.
Improving Visual Attention in Schizophrenia

This study investigates whether visual attention can be improved in individuals with schizophrenia by stimulating the brain via transcranial Direct Current Stimulation (tDCS).

Individuals with schizophrenia tend to display abnormal visual attention when performing visual tasks, typically spending less time on salient features of the stimuli (e.g. core facial features or body movement in social tasks), and instead focusing on idiosyncratic features of an image or video. Poor visual attention in schizophrenia has been directly linked to poorer social cognitive performance (e.g. recognizing emotional expressions or social cues) which can impact an individual's day to day functioning.

Transcranial Direct Current Stimulation (tDCS) is a form of noninvasive neurostimulation which has been proposed as a therapeutic procedure in numerous psychiatric disorders. TDCS in schizophrenia has been demonstrated to improve a wide range of cognitive processes, and in healthy adults, tDCS has been demonstrated to improve aspects of social cognition. TDCS thus appears to be a promising therapeutic technique that may be useful for improving visual attention in patients with schizophrenia, and potentially impact social cognitive performance via an underlying mechanism tying the two. This study will compare visual performance in individuals with schizophrenia across two conditions: active anodal tDCS and sham tDCS, while also comparing between brain stimulation sites: rTPJ and dmPFC.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV-TR or DSM-5 diagnosis of schizophrenia or schizoaffective disorder and clinically stable (i.e. no hospitalizations) for at least 8 weeks prior to informed consent and be on a stable medication regimen for at least 6 weeks with no dose changes for a minimum of 2 weeks prior to informed consent.

Exclusion Criteria:

* The presence or history of a pervasive developmental disorder or mental retardation as defined by a premorbid IQ \< 70
* Presence or history of medical or neurological disorders in which neural stimulation would be contraindicated (e.g. presence of epilepsy or history of seizures)
* Presence of sensory limitations, including visual or hearing impairments that interfere with assessment
* History of electroconvulsive therapy
* Not proficient in English
* Presence of substance abuse in the past one month or dependence not in remission in the past six months
Using Psychophysics Methods to Investigate Sensory Dominance After Cataract Surgery

Using Psychophysics Methods for Quantitative Assessment of Sensory Binocular Imbalance After Cataract Surgery

Using binocular phase combination paradigms and binocular rivalry paradigms to quantitatively assess the degree of sensory binocular imbalance in patients following cataract surgery, investigating the relationship between unilateral and bilateral cataracts in children and varying severities of cataracts in adults with respect to sensory ocular dominance, and forecasting the postoperative quality of life for patients.

Eligibility Criteria:
Inclusion Criteria:

1. Ages between 6 and 90 years old, and the individual or legal guardian is capable of understanding and voluntarily signing an informed consent form;
2. No history of ocular trauma or intraocular surgery, no physical or medical treatments have been undergone, and the clinical diagnosis in the medical records is age-related, congenital, or developmental cataract patients;
3. Best-corrected visual acuity in both eyes is greater than 0.8 before the study, fusion ability is normal as checked by Worth's 4-dot test, and at least 1 month has passed since the last surgery;
4. Good communication skills and the ability to understand and grasp the trial;
5. No significant contraindications to surgery found in preoperative systemic and ocular examinations.

Exclusion Criteria:

1. Patients with traumatic or complex cataracts;
2. Those diagnosed with glaucoma before or after surgery;
3. Individuals with a history of intraocular surgery (such as vitrectomy) or laser treatment;
4. Exclude those with severe ocular comorbidities (including microphthalmia, aphakia, anterior segment dysgenesis, uveitis, optic nerve dysplasia, retinopathy of prematurity, congenital glaucoma, etc.) and severe systemic comorbidities (including syndromes affecting connective tissue function, such as Marfan syndrome, homocystinuria, or Down syndrome, severe birth defects, and epilepsy);
5. Any systemic diseases related to the eyes, such as rheumatic immune diseases;
6. Those with surgical records indicating any severe intraoperative complications during cataract surgery;
7. Individuals who cannot cooperate with the examination.
African American Cancer Prevention Project: Establishing a Cohort to Investigate Health Disparities

The goal of this research study is to learn if certain factors may affect cancer rates among African Americans. These factors include behavioral, social, and environmental factors including diet and physical activity, cigarette smoking, cancer screening, health care, neighborhood environment, and mental health.

Study Procedures:

If you decide to take part in this study, you will complete study procedures at month 36 (the day you sign this consent form) and again every year for the next 2 years. These procedures include completing a questionnaire, having your body measurements taken, and receiving self-help materials.

At month 36, you will complete the questionnaire on a computer that is set up at the church in a private room. The questions will be about nutrition, exercise, tobacco and alcohol use, your neighborhood, age, education, social status, health status, stress, and racism. It should take about 75 minutes to complete. Your waist, hip, height, and weight will also be measured while you are in the private room.

Every year after that for the next 2 years, you will go back to the church to complete a new questionnaire each time. The questionnaires should take about 75 minutes to complete each time.

If you cannot get back to the church, you may complete the questionnaire over the phone. The study staff will provide you with the phone number and directions on how to complete the survey over the phone. Your measurements will be taken at the church, or at the Behavioral Research and Treatment Center (BRTC) at MD Anderson, whichever is more convenient for you.

At each study visit, you will also receive self-help materials on how to lower your risk for developing cancer.

Questionnaire Data:

Your questionnaire data will be used for research purposes only. Your responses will not be shared with your personal doctor. If you feel you need a doctor's opinion about anything that is asked about in the questionnaire (such as mental or emotional difficulties or symptoms), please contact your personal physician.

About 1 month after each you complete the questionnaire each time, the research staff will review and score your responses. If your scores suggest signs of depression, you will be given a list of resources for mental health screening.

Length of Study:

After 5 years, your active participation in this study will be over. You may be contacted in the future to see if you would agree to take part in other research studies.

This is an investigational study.

Up to 1,501 people will take part in this study. All will be enrolled at MD Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. be age 18 years old and above
2. read and write English
3. live in the Houston metro area
4. have a viable (working) telephone number and home address

Exclusion Criteria:

1) None.
Individualized Nutritional Counselling During Chemotherapy for Colorectal Cancer (COLONUT)

The purpose is to study the effect of individualized nutritional counselling compared to usual nutritional care on cross-sectional muscle area in patients with stage IV colorectal cancer during first line chemotherapy. Secondary, effect on total lean body mass, treatment intensity, physical functioning, quality of life and survival will be studied.We hypothesize that patients in the intervention arm benefit from individualized nutritional counseling.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Stage IV colorectal cancer
* Scheduled for treatment with first line chemotherapy, either CAPOX(-B), FOLFOX(-B) or capecitabine(-B)
* CT scan suitable for evaluating muscle mass at L3 level
* Understanding of the Dutch language
* Able and willing to give written informed consent

Exclusion Criteria:

* Chemotherapy in the previous three months
* WHO performance status ≥ 3
* Long-term high dose of corticosteroids: ≥ three weeks ≥ ten milligram prednisolon or equivalent
Beta-lactoglobulin, Immobilisation and Muscle Protein Synthesis

The objectives of this study are to:

1. Establish whether combined β-lactoglobulin supplementation and resistance training for 1 week prior to 5 days of limb immobilisation will attenuate the decrease in integrated free-living rates of MPS during short-term muscle disuse.
2. Establish whether combined β-lactoglobulin supplementation and resistance training for 1 week prior to limb immobilisation will attenuate the decrease in muscle mass and strength during short-term muscle disuse.

The objectives of this study are to:

1. Establish whether combined β-lactoglobulin supplementation and resistance training for 1 week prior to 5 days of limb immobilisation will attenuate the decrease in integrated free-living rates of MPS during short-term muscle disuse.
2. Establish whether combined β-lactoglobulin supplementation and resistance training for 1 week prior to limb immobilisation will attenuate the decrease in muscle mass and strength during short-term muscle disuse.

Hypotheses

1. Combining β-lactoglobulin and resistance training for 1 wk prior to 5 d of limb immobilisation will attenuate the decrease in integrated muscle protein synthesis, muscle fibre CSA, quadriceps muscle strength, and leg lean mass during muscle disuse.
2. Combining β-lactoglobulin and resistance training for 1 wk prior to 5 d of limb immobilisation will attenuate the decrease in muscle fibre CSA, quadriceps muscle strength, and leg lean mass during muscle disuse.

Eligibility Criteria:
Inclusion Criteria:

* Male and female
* Aged 18-45 years
* Healthy
* Physically active (≥150-300 minutes of moderate-intensity aerobic physical activity per week OR 75-150 minutes of vigorous-intensity aerobic physical activity per week)
* Eumenorrheic and not taking any hormonal birth control (females)

Exclusion Criteria:

* Dairy allergy or intolerance
* Lower limb injury or surgery in the last 6 months,
* Lower limb osteoarthritis or other musculoskeletal disorder
* A musculoskeletal or blood blotting disorder
* An allergy to local anaesthetic
* Currently pregnant
* Current use of blood thinning medications
* Volunteers that take part in structured resistance exercise training
* Taking supplements considered to be anabolic to skeletal muscle (protein supplements, creatine, or omega-3 supplements)
* Consuming more than 1.2 grams of protein per kilogram of body mass per day in their habitual diet.
* Volunteers involved in other studies at the time of enrolment
* Volunteers who have taken part in a tracer study in the past 18 months
* If without an understanding of verbal or written English
* Volunteers with a history of eating disorders
Digital Medicine in Meditation

This study will investigate the acute response to meditation during a week-long meditation retreat at the Chopra Center as measured by the continuous, simultaneous monitoring of numerous biometric parameters in selected cohorts of experienced and novice meditators during periods of meditation and specific breathing techniques. Comparisons between cohorts as well as over time will allow for the identification of meditation and/or breathing-related changes.

The biometric responses to meditation and breathing techniques will be compared between novice and experienced meditators, as well as initial versus final biometric responses in all participants stratified by cohort. Investigators hypothesize that novice meditators will experience a measurable change in response to mediation over the week-long retreat, whereas experienced meditators will demonstrate a more robust response than novice meditators on the first day of the retreat with less change over the retreat.

Eligibility Criteria:
Inclusion Criteria:

* Adult over age 18 who are already registered to participate in the week-long "Seduction of the Soul" retreat.
* Capable of providing informed consent

Exclusion Criteria:

* Chronic requirement for daily use of chronotropically active medications including beta-blockers, non-dihydropyridine calcium channel blockers, clonidine or beta-agonist inhalers.
* Implantable pacemaker or cardioverter-defibrillator.
* Known allergy to adhesives.
A Remote, Decentralized Opioid Use Disorder Study to Evaluate Patient Engagement With a Game-Based Digital Therapeutic

The purpose of this study is to evaluate how patients use and engage with a game-based mobile application that is designed to treat opioid use disorder.

This is a randomized, controlled, open-label, decentralized study to evaluate patient engagement with PEAR-008, a game-based digital therapeutic for the treatment of opioid use disorder.

PEAR-008 is a new version of reSET-O, an FDA-authorized mobile application treatment (available by prescription only) for opioid use disorder. The study will examine if changing the application's delivery format and enhancing clinical content affects how patients use and interact with the intervention.

Prospective participants will complete a short screening assessment and if eligible complete informed consent procedures at the beginning of the Baseline visit. Qualifying participants will attend weekly virtual study visits during the 8-week treatment period.

In addition to weekly assessments, additional assessments will be administered at week 4 and week 8. Participants will be asked to complete a follow-up assessment 4 weeks after completing treatment.

Eligibility Criteria:
Inclusion Criteria:

* Provide informed consent prior to any study specific assessments being performed
* Between 18 and 60 years old, inclusively
* Proficient in English language
* Within the first 120 days of starting buprenorphine treatment
* Receiving buprenorphine pharmacotherapy under the care of a licensed healthcare provider and willing to provide the provider or practice name
* Capable of using common software applications on a mobile device (smartphone)
* Access to an internet-enabled smartphone for the duration of the study, meeting minimal operations systems (OS) requirements
* Interest in using a digital therapeutic for Opioid-use Disorder
* No prior history of reSET-O use
* Has not participated in user testing of PEAR-008 or any investigational drug trials within the past 30 days of enrollment

Exclusion Criteria:

* On methadone or naltrexone pharmacotherapy
* Unable to use English to participate in the consent process, interventions, or assessments
* Inability to comply with study procedures
Zinc and/or Probiotic Supplementation of Rotavirus and Oral Polio Virus Vaccines

Background: Strategies are needed to improve oral rotavirus vaccine (RV), which provides suboptimal protection in developing countries. Probiotics and zinc supplementation could improve RV immunogenicity by altering the intestinal microbiota and immune function.

This study enrolled infants 5 weeks old living in urban Vellore, India to assess the effects of daily zinc (5 mg), probiotic (1010 Lactobacillus rhamnosus GG) or placebo on the immunogenicity of two doses of RV (Rotarix,GlaxoSmithKline Biologicals) given at 6 and 10 weeks of age. Probiotics and zinc (or placebo) were provided for six weeks. A single dose of test product was administered daily one week prior to first study dose of rotavirus and polio vaccines through 1 week following second study dose of rotavirus and polio vaccines.

Co- Primary objectives:

1. To evaluate the serologic immune response to rotavirus vaccine (sero-conversion or four-fold rise in rotavirus immunoglobulin A (IgA) antibodies) among Indian infants receiving zinc supplementation given daily for a week prior to the administration of the first dose through a week following the second dose of oral rotavirus vaccine compared to those receiving a zinc placebo.
2. To evaluate the serologic immune response to rotavirus vaccine (sero-conversion or four-fold rise in rotavirus IgA antibodies) among Indian infants receiving probiotic supplementation given daily for a week prior to the administration of the first dose through a week following the second dose of oral rotavirus vaccine compared to those receiving a probiotic placebo.

Eligibility Criteria:
Inclusion Criteria:

* Infants 35-41 days old
* Live in area under surveillance
* Current weight ≥3.2 kg
* No syndromic evidence of immunocompromise as determined by medical doctor
* No prior illness requiring hospitalization
* No current medical condition as determined by medical doctor which precludes study involvement
* Available for follow up for duration of study (through approximately 14 weeks of age)
* Parents/guardians of infant are able to understand and follow study procedures and agree to participate in the study by providing signed informed consent

Exclusion Criteria:

* Child has history of atopic symptoms
* Child has a known digestive system defect
* Child has history of chronic diarrhea
* Child has major congenital anomalies
* Child has received a prior dose of rotavirus vaccine
* Child has received a prior dose of polio vaccine (beyond the birth dose)
Clinical Implementation of Surface-guided Radiation Therapy in Vulvar Cancer

This prospective study evaluated the clinical implementation value of an optical surface monitoring system (OSMS) in the radiotherapy setup for patients with vulvar cancer, compared to standard laser-based setup

This was a prospective single-centre trial to investigate the value of OSMS, and we hypothesized that using OSMS would reduce setup error in vulvar cancer treatment compared to a standard laser-based setup. A dose of 45 Gy was delivered to the clinical target volume with intensity-modulated radiation therapy (IMRT) for a total of 25 fractions, followed by 16 to 24 Gy of local electron beam supplementation. Marks were placed on each patient's skin to align the room lasers for presetup, and the setup was completed with information from the OSMS. The deviation values in three translation directions, lateral (Lat), longitudinal (Lng), and vertical (Vrt), and three rotation directions, Rtn (rotation along the z-axis), Pitch (rotation along the x-axis), and Roll (rotation along the y-axis) were obtained. The absolute values of setup error and error distribution of the standard laser-based setup and OSMS were compared.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be informed of the investigational nature of this study and give written informed consent before treatment.
2. Age ≥18 years and ≤ 85 years.
3. Patients with histologically confirmed vulvar cancer.
4. No evidence of distant metastasis on CT, MRI or positron emission tomograph (PET)/CT.
5. No contraindications to CT scanning.
6. Indications for radiotherapy for vulvar cancer.
7. Adequate marrow: neutrophile granulocyte count ≥1.5\*10\^9/L, hemoglobin ≥ 80 g/L, platelet count ≥100\*10\^9/L.
8. Normal liver and kidney function: Creatinine (Cr) \< 1.5 mg/dl, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) \< 2\*upper limit of normal (ULN).

Exclusion Criteria:

1. No pathological diagnosis.
2. Remote metastasis.
3. Anticipated intolerance of pelvic radiotherapy.
4. Any severe disease which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control, and emotional disturbance.
Effect of Aspirin Pretreatment or Slow Dose Titration on Flushing and Gastrointestinal Events in Healthy Volunteers Receiving Delayed-release Dimethyl Fumarate

The primary objective of the study is to evaluate whether premedication with 325 mg microcoated aspirin (ASA) tablet or a slow-titration dosing schedule of BG00012 reduces the incidence and severity of flushing and GI events following oral administration of BG00012 dosed at 240 mg twice a day (BID) in healthy volunteers. The secondary objective of this study is to evaluate the safety and tolerability of BG00012 when administered orally as a 240 mg BID dose regimen with and without 325 mg ASA premedication or following a slow-titration dosing schedule in healthy volunteers.


Eligibility Criteria:
Key Inclusion Criteria:

* Must give written informed consent and any authorizations required by local law
* Must have a body mass index (BMI) of between 18.0 to 34.0 kg/m\^2,inclusive.
* Ability to complete the tolerability scales by accurately using the hand-held subject reporting device
* Subjects of childbearing potential must be willing to practice effective contraception

Key Exclusion Criteria:

* History of clinically significant diseases
* History of severe allergic or anaphylactic reactions
* Intolerance to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs)
* Diarrhea, constipation, abdominal pain, flushing or nausea within 28 days prior to Day 1

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.