cyrilzakka/clinical-trials huggingface dataset:
Environmental Influence on Gambling Behavior

In France, the prevalence of problem gambling and risk has been estimated at 1.3%. This disorder, currently considered a behavioral addiction is characterized by a loss of control and an excessive focus on the game.

The literature on intervening psychological mechanisms in the development of the game led to think that the size of loss of control, central among players, could be understood as a reduction in control capacity but also as automatic activation behavior game.

The task of Go-Nogo, commonly used in cognitive psychology, assesses the automatic and controlled components of behavior. Furthermore, different models of the concept of addiction underline the importance of the environment associated with addiction. However, no study takes into account the interaction between the game environment and the involvement of these mechanisms.

In this study, patients will realize, on a computer, various exercises (called "Go-Nogo") whose principle is: 2 symbols (for example, a circle and a square) appear in random order on the screen computer. The patient will not press the response button (key on the keyboard) that upon the occurrence of one of the two symbols, in dependence upon the command that it has been given by the psychiatrist, and this as quickly as possible. The patient will successively perform 3 versions of this exercise (with a neutral wallpaper, with neutral/games images or with neutral/games tones).Order of the 3 versions will be determined by randomization.

Eligibility Criteria:
Inclusion Criteria:

* For pathological gambler (JP): active casino players meet the diagnostic criteria for pathological gambling according to DSM-IV-TR
* For social player (JS): casino players who score the SOGS is less than or equal to 2, and playing at least once a month in a money game and chance.
* For non-gamer witnesses (T): play less than once per month to any type of gambling, except for Lotto and Euromillion where the threshold is increased at least once a week. These two draw games are considered more socially enrolled in a leisure practice without necessarily enroll in gambling.
* Right handed
* Aged between 18-60 years.
* Without psychotropic treatment or treatment with a stable and unchanged for over a month.

Exclusion Criteria:

* Participants with a problem of visual acuity and / or uncorrected hearing.
* Other current addiction (except tobacco, for reasons of feasibility).
* Current Psychiatric comorbidity
* Treatment psychotropic introduced or changed for less than a month.
* Subjects with atrial fibrillation, with a pacemaker and / or receiving antiarrhythmic drugs
A Bioequivalence Study of Capecitabine Tablets

1. purpose: To conduct the relative bioavalability study of Capecitabine tablets 500 mg (Jiangsu Chia-Tai Tianqing Pharmacy Co. Ltd.) versus XELODA® 500 mg tablets (Manufactured by Roche Pharma AG)
2. Experimental Design： Two-period crossover design
3. Test drug: Capecitabine tablets Reference drug: XELODA
4. Sample size：24


Eligibility Criteria:
Inclusion Criteria:

* Patients must have histopathologically /cytologically confirmed breast cancer or colorectal cancer，without chemotherapy or only adjuvant chemotherapy, and had previously received one or two standard chemotherapy regimens for patients;
* Age: 18-70 years, gender: both，BMI≥17，Eastern Cooperative Oncology Group (ECOG) performance status：0-2，Life expectancy greater than 3 months;
* Patients must have normal bone marrow function, liver and kidney function; adequate organ function in the last 1 week, meeting the following: ANC≥1.5×109/L，PLT≥80×109/L, Total bilirubin≤1.5×the upper limit of normal, ALT,AST≤2.5×the upper limit of normal, creatinine≤1.5×the institutional upper limit of normal.
* Patients who has retreatment could be enrolled at least 4 weeks after the last chemotherapy and radiotherapy.
* Patients must volunteer to participate and sign informed consent form.

Exclusion Criteria:

* Suffering from heart, liver, kidney disease or severe acute and Organ invasion disease;
* Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil, or known DPD (Dihydropyrimidine Dehydrogenase) deficiency.
* Pregnant or breast-feeding female
* Only bone metastasis lesions, no other measurable lesions
* Known brain metastasis or history of organ transplantation
* Have long-term systemic steroid therapy
* Serious diseases of vital organs; other malignancies which is not cure
* Use of chemotherapy in the last 4 weeks
* History of drug/alcohol addiction or a positive hepatitis screen including hepatitis B surface antigen, HCV or HAV (IgM) antibodies
* Patient having abnormal serum calcium level at screening visit which as judged by Investigator could lead to safety risk to the patient upon participation in the trial or could interfere with the conduct of the trial.
* Pre-existing motor or sensory neurotoxicity of a severity grade 2 by NCI CTCAE criteria or known, existing uncontrolled coagulopathy.
* Subjects are thought unsuitable for the study by investigators;
* Inability to comply with protocol or study procedures in the opinion of the investigator;
ACTHAR Gel for Cutaneous Sarcoidosis: An Open Label Trial

ACTHAR gel has efficacy in the treatment of cutaneous sarcoidosis

Sarcoidosis is a multisystem granulomatous disease of unknown cause. Although sarcoidosis most commonly affects the lung3, it may affect any organ. Although corticosteroids are recognized as the drug of choice for sarcoidosis, ACTH is the only drug that is FDA-approved for this disorder. However, there is limited data on the efficacy of ACTH for this condition.

Presently, corticosteroids as considered the drug of choice for the treatment of cutaneous sarcoidosis. However, ACTHER GEL not only has obvious anti-inflammatory effects by resulting in corticosteroid production, but it may also activate melanocortin receptors. The melanocortin system has powerful anti-inflammatory properties that may be beneficial in the treatment of cutaneous sarcoidosis.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must have biopsy-proven sarcoidosis.
2. a) Patients with active cutaneous sarcoidosis and two active lesions on stable therapy or no therapy for at least two months AND/OR b) Patients with active cutaneous sarcoidosis and lupus pernio lesions on stable therapy or no therapy for at least two months. A maximum of 5 patients may be enrolled fulfilling criterion b) above.
3. Both lesions must have a SASI induration score of \> 1 and a SASI induration + erythema score of \> 2.
4. If two lesions are present, one must be \> 1cm in diameter and the subject must be willing to have it biopsied. The second lesion must be at least 0.5 cm in diameter.
5. If a subject has only lupus pernio facial lesions, one needs to be at least 0.5 cm in diameter.

Exclusion Criteria:

1. Previous toxic or allergic reaction to ACTHAR gel
2. The presence of another skin condition in addition to sarcoidosis that would interfere with the assessment of the sarcoidosis skin lesions.
3. Uncontrolled hypertension.
4. Uncontrolled diabetes.
5. Active infection.
6. A medical condition that, in the opinion of the investigator would place the subject at significant risk by administering ACTHAR gel.
Respiratory Rehabilitation Exercises in Older Adults With Acute Exacerbations of Chronic Obstructive Pulmonary Disease

The purpose of this randomized controlled trial was to evaluate the effects of a respiratory rehabilitation exercise training package on dyspnea, cough, exercise tolerance, and sputum expectoration of hospitalized elderly patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD). Using purposive sampling, 61 participants were recruited and randomly assigned to either the experimental group (n = 30) or the control group (n = 31). The experimental group participants received the respiratory rehabilitation exercise training twice a day and 10-30 minutes per session for four days. The control group participants received usual care and health education. Data were collected at baseline and at the end of the four-day intervention.

The respiratory rehabilitation exercise training package included: (a) Disease awareness: The doctor explained the disease to patients and their families through the chest X-ray, (b) Sputum clearance treatments: Easily understood postural drainage cards were provided to the patients and families to assist with proper sputum clearance procedures, (c) Pursed lip breathing training: Devices were provided to the patients to ensure that the breathing exercises were completed properly, (d) Upper-limb exercise with breathing pranayama: Towels were provided to the patients to assist with upper-limb exercises properly, (e) Walking training with breathing pranayama: Legs were elevated while inhaling, and returned to the position while exhaling, and (f) Assign a pulmonary rehabilitation program coordinator: Coordinators were assigned to assist the patients in nutrition management and health education.

Eligibility Criteria:
Inclusion criteria:

1. diagnosed with moderate COPD with moderate acute exacerbation
2. over 65 years of age
3. conscious clear
4. with shortness of breath or dyspnea that was not caused by heart disease, pneumothorax, or pulmonary edema
5. had received bronchodilator aerosol therapy or antibiotic treatment, but had not been treated with an antitussive

Exclusion Criteria:

1. unstable vital signs
2. blood oxygen concentration lower than 90%
3. unstable psychological status, hemoptysis, pneumothorax, pulmonary edema, or using the respirator
Feedback System of PROMS in Children With Burns

The primary objective of the overall study is to determine the feasibility and usefulness of a feedback system that delivers BOQ results to physicians in "real time" during outpatient encounters using iPads.

The primary objective of this pilot study is to ascertain the feasibility and usefulness of a feedback system that provides clinicians with parent-proxy reported outcomes measure data during routine outpatient encounters for burn treatment.

The secondary objective of this first phase of the study is to determine clinicians' and parents perception of the experience of completing the BOQ+P and/or the usefulness of the information that was provided to the clinician and parent/guardians(s). For this reason we will collect a brief debriefing questionnaire from physicians and another from parents.

Eligibility Criteria:
Inclusion Criteria:

* Children between the ages of 0 and 18 years of age, receiving outpatient burn care at Shriners Hospitals for Children - Boston with total body surface area burn of ≥ 5% and/or a burn injury to face, hands, feet or genitalia. English or Spanish speaking and literate

Exclusion Criteria:

* Clinician overriding a patient to serve on the study because of medical/psychiatric problems that might in the opinion of the clinician overwhelm the goals/purposes of the study.
Xylitol Use for Decolonization of C. Difficile in Patients With IBD

This is a randomized, placebo-controlled, dose-ranging study to assess the safety and efficacy of xylitol as an oral therapeutic for decolonization of C. difficile in IBD patients. A total of 99 patients who meet eligibility criteria will be randomized 1:1:1 to one of two xylitol doses or placebo arm. All arms will receive an identical capsule dosing for four weeks. Microbiome assessment and C. difficile testing will be performed at baseline, week 4, 8, 26, and 52.

This randomized placebo-controlled dose-finding trial will assess the safety and efficacy of xylitol as an oral therapeutic for decolonization of C. difficile in the IBD patient population.

Participants with confirmed IBD diagnosis who are scheduled for an outpatient colonoscopy for any reason at Brigham and Women's Hospital or clinic appointment at the Crohn's and Colitis Center will be eligible for screening. Participants will be screened for C. difficile colonization via colonic wash sampling during colonoscopy or whole stool following a clinic appointment.

Participants may only have inactive or mild IBD based in clinical scores (see inclusion criteria) to be eligible for screening. Risk factors for colonization will be assessed by comparing colonized vs. not colonized patients.

Participants who are found to be colonized will be randomized 1:1:1 to either placebo or one of two dosing groups of xylitol. The dose A treatment arm will receive 7.5 grams daily of xylitol via gel capsule for 4 weeks. The dose B treatment arm will receive 15 grams daily of xylitol via gel capsule for 4 weeks. The placebo arm will receive identical capsule dosing for 4 weeks. Participants will end dosing at week 4, but monitoring will continue through week 52. Both participants and study team will be blinded to treatment arm allocation.

The primary endpoints assessed are decolonization at week 8 as well as safety and tolerability through week 8. In addition, secondary efficacy outcomes including IBD disease activity and development of CDI, which will be evaluated at week 8, week 26 and week 52. Disease activity and symptoms will be recorded from informed consent through the week 52 trial visit.

Stool samples for biomarker assessments and C. difficile testing will be collected at scheduled trial visits per Schedule of Assessments.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent.
2. Male or female ≥ 18 years of age
3. IBD diagnosis (CD, UC or indeterminant Colitis will be permitted)
4. Inactive or mild IBD (HBI score ≤ 7; Partial Mayo score ≤ 4)
5. Presenting for outpatient colonoscopy or clinic appointment for any indication

Exclusion Criteria:

1. Unable to provide consent
2. Patients with previous colectomy, ostomy, J-pouch, or previous colon surgery (excluding appendectomy)
3. Unable to complete study procedures
4. Chronic use of antibiotics
5. Inability or unwillingness to swallow capsules
6. Allergy to xylitol
7. Stool positive for Listeria monocytogenes
Transplantation of Deceased Donors With COVID-19 Into COVID-19 Negative Recipients Utilizing Casirivimab and Imdevimab Antibody Cocktail

This study will look to increase the donor pool for the solid organ transplant population by transplanting patients who died with COVID-19 but not from COVID-19 utilizing casirivimab and imdevimab antibody cocktail to prevent the transmission of the virus.

This is single-center, proof of concept study that is expected to last up to three months. The target enrollment for this study is 14 subjects ≥18 years of age with a need of a kidney, liver or heart. This study will investigate the effects of the investigational product during a four-week intervention phase followed by a 12-month observation phase. Study population will be derived from patients in Northwell Health Transplant Center.

Eligibility Criteria:
Inclusion Criteria:

1. Subject provides written informed consent prior to initiation of any study procedures.
2. Understands and agrees to comply with planned study procedures.
3. Adult ≥18 years of age at time of enrollment, pediatric ages will be excluded.
4. Subject consents to receiving a COVID-19 positive organ (kidney, liver, or heart)

   a. Deceased immunocompetent donor with positive SARS-CoV-2 RT-PCR testing from the respiratory tract (upper or lower): i. Within 21 days since the date of COVID-19 diagnosis OR ii. Within 90 days since the date of COVID-19 diagnosis
5. Subject is confirmed COVID-19 negative confirmed by PCR at time of transplant with no signs and symptoms consistent with COVID-19
6. All candidates must be fully vaccinated 2 weeks prior to enrollment a. When applicable candidates can receive a booster vaccine as defined by the FDA/CDC

Exclusion Criteria:

1. Any exposure to investigational medications targeting COVID-19
2. Previous use of casirivimab with imdevimab antibody cocktail (REGEN-COV)
3. Previous treatment of COVID-19 with a monoclonal antibody
4. Active COVID-19 infection
5. Allergy to casirivimab with imdevimab
6. Pregnant patients
7. Prior transplant
8. Hepatitis C virus/NCT positive deceased donors
Development of Polygenic Risk Scores in Colon Cancer Patients Through the Study of Ancestry and Diversity in Genetic Maps of the Brazilian Population - ORIGEM Project

Development of a polygenic risk score based on somatic and germline genetic information from patients with colorectal cancer

Colorectal cancer (CRC) is the third most common cancer diagnosed in both men and women. Approximately 70% of CRC cases originate from spontaneous point mutations in oncogenes, tumor suppressor genes, and genes related to DNA repair mechanisms (Nigin et al., 2023). The remaining 30% result from hereditary mutations, of which 5-6% involve high-penetrance genes. Genetic predisposition due to pathogenic germline variants in high-risk cancer-associated genes has been implicated in 2-8% of all CRC cases, increasing to 6-10% when considering pathogenic mutations in both high- and moderate-penetrance genes.

For individuals with certain hereditary cancer syndromes, the risk of developing colorectal cancer can reach 50-80% in the absence of endoscopic and/or surgical intervention. Therefore, characterizing high-, moderate-, and low-penetrance genes within a population is crucial for understanding hereditary tumorigenesis and guiding more cost-effective screening strategies.

Genetic studies comparing genomes from populations of different ethnic backgrounds have demonstrated that ancestry plays a significant role in genetic predisposition to CRC. Given the high level of genetic admixture in the Brazilian population, studies focused solely on populations of European ancestry fail to provide a representative model for application in highly admixed populations like Brazil.

In this context, the present study aims to utilize next-generation sequencing (NGS) in a cohort representative of the Brazilian population with CRC and controls to develop a Polygenic Risk Score (PRS). This score could impact cancer screening and prevention strategies, as well as genetic counseling for patients and their families. The hypothesis is that genetic mapping-including ancestry, germline, and tumor genetic variability-in Brazilian colorectal cancer patients will provide valuable data for developing a PRS that may eventually guide more targeted and cost-effective screening strategies for our population.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years;
* Histologically confirmed diagnosis of colorectal cancer;
* Have available tumor material for somatic sequencing, obtained from biopsy or routine surgery;
* Sign the informed consent form (ICF) for the study.

Exclusion Criteria:

• Pregnants
Neonatal and Paediatric Pharmacokinetics of Antimicrobials Study

The aim of NAPPA is to develop new models to improve our understanding of how children process ('metabolise') penicillins, to help us discover if we can improve the dosing regimens used for children in the future. The study population will involve children and neonates who need a penicillin antibiotic as part of their normal National Health Service (NHS) care, and who also need blood tests or intravenous access. Therefore the antibiotic study can be done without the need for any extra invasive procedures, and there will be no change to the medication therapy received by participants. In addition, NAPPA will evaluate whether it is feasible to measure antibiotic levels on a tiny drop of blood put onto absorbent paper ("dried blood spot"). This allows the sample to be stored and tested later on. NAPPA will compare the level of the antibiotic using this method with the level measured in the usual way, to show if this is a reliable method that could be used routinely in the future.


Eligibility Criteria:
Inclusion Criteria:

* Child aged under 16 years receiving one of the specified penicillins and with intravenous access or blood test(s) as part of their routine clinical care.
* Informed consent form signed by parent or legal guardian.

Exclusion Criteria:

* Any child or infant unlikely to survive 48 hours after recruitment.
* Patient known to be pregnant.
* Known allergy or hypersensitivity to beta-lactam antibiotics (including penicillins and cephalosporins) or beta-lactamase inhibitors.
* Patient receiving (or planned to receive) haemofiltration, haemodialysis, peritoneal dialysis, extracorporeal membrane oxygenation (ECMO) or cardiopulmonary bypass.
Functional Brain Imaging of Medication Treatment Response in Mild Alzheimer's Disease Patients

The purpose of this study is to determine whether standard medications approved for Alzheimer's disease treatment differ in their action on brain functioning and whether any observed brain activity differences as result of treatment are associated with particular patterns of dementia improvement or reduced decline.

This study seeks to differentiate task-related and resting brain activity patterns captured via functional magnetic resonance imaging (fMRI) and associated with two common Alzheimer's disease (AD) medications, equivalent in acetylcholinesterase inhibition effect (AChEI) but differing with respect to allosteric nicotinic receptor modulation effect. It is the primary aim of this project to gain a better understanding of the brain mechanisms involved in the attentional and executive skills improvements associated with nicotinic receptor modulation in mild AD patients.

To address this question, this 12-week continuous treatment, double-blind, head-to-head dose-escalation treatment trial seeks to visualize any treatment response unique to allosteric nicotinic receptor modulation and to associate these fMRI data with standard cognitive assessment outcomes. Using in-scanner tasks shown to reliably elicit brain activity in cortical regions important to memory and attention, this treatment trial will examine both resting and task-related BOLD signal characteristics in a well-characterized sample of 36 mild AD patients after periods of low dose and high dose AD dementia treatment with either galantamine hydrobromide (AChEI + nicotinic receptor modulation) or donepezil hydrochloride (AChEI only). Both the low and high dose imaging comparisons between treatment groups will be equivalent for 35% AChEI-effect, which may allow for the isolation of BOLD signal unique to allosteric nicotinic receptor modulation in both brain at rest and task-related brain states.

Eligibility Criteria:
Inclusion Criteria:

* Must meet diagnosis of mild Alzheimer's disease
* Must have a family member or caregiver who is willing to attend all study visits and provide information on your participation in the study
* If female, must be post-menopausal
* Must be able to swallow tablets

Exclusion Criteria:

* Metal implants or medical devises unsafe for MRI use
* Pre-menopausal female
* HIstory of recent head injury
* Significant major, life-threatening illness or injury (e.g., stroke, AIDS, etc.)
* Vascular dementia or any dementia other than Alzheimer's Disease
* History of significant alcoholism or drug abuse
* History of seizure disorder, developmental delay or major psychiatric illness