cyrilzakka/clinical-trials huggingface dataset:
Development of Attention and Its Relationship With Emotions in Children and Adolescents

Our aim was to describe the development and usability of a mobile device-based game therapy software for ADHD.

A total of 51 ADHD children and 52 healthy children were included in the study. At baseline, subjects underwent tests such as ADHD symptom-related scale assessments, computer-assisted information processing tests, and physiological-psychological tests, after which participants completed a 4-week game intervention training at home. After complete completion of the intervention, subjects repeated all tests from the baseline period and answered treatment satisfaction questions.

Eligibility Criteria:
Inclusion Criteria:

* ADHD-a. Age between 6-12 years, any gender.
* ADHD-b. Outpatient patients diagnosed with ADHD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
* ADHD-c. Patients and/or their guardians willing to participate in the study and provide informed consent. Participants aged 8 and above should also sign a child's informed consent form.
* HC. The control group of healthy participants are recruited from a secondary school in Nanjing, matching the age and gender of the ADHD group.

Exclusion Criteria:

* a. Neurodevelopmental disorders such as cerebral palsy, epilepsy, adrenoleukodystrophy, and other similar conditions.
* b. Severe mental disorders including tic disorders, autism spectrum disorders, intellectual disability, schizophrenia, bipolar disorder, depressive disorders, specific learning disorders, and other significant psychiatric conditions.
* c. Individuals exhibiting ADHD-like symptoms due to hearing impairments.
* d. Requirement of any central nervous system medication (including both traditional and Western medicine as well as dietary supplements) such as antipsychotics or antidepressants at any stage of the study.
* e. Patients who have received systematic treatment with two different categories of ADHD medications without improvement.
* f. Individuals with color blindness or any other condition that would prevent proper use of the software.
* g. History of or current gaming addiction.
Memory and Antioxidants in Vascular Impairment Trial

This is a 24-week randomized, double-blind, placebo-controlled parallel group design study involving Vascular cognitive impairment-no dementia (VCIND) patients to evaluate the efficacy and safety of oral NAC supplementation (2,400 mg daily) as an add-on therapy to improve cognitive function in patients undergoing cardiac rehabilitation (CR). The CR program consists of a harmonized aerobic and resistance training in a supervised group setting. Eligible patients will be randomized to receive NAC (four 600 mg capsules given as 2 capsules in the morning and 2 capsules in the evening) or matching placebo capsules. The initial NAC dosage will be 600mg/day (one 600mg capsule in the morning) for the first week, followed by 1,200 mg/day (one 600 mg capsule in the morning, one 600mg capsule in the evening) for the second week, followed by 1,800 mg/day (two 600mg capsules in the morning, one 600mg capsule in the evening) for third week, followed by 2,400mg/day (two 600mg capsules in the morning, two 600mg capsules in the evening) for the following 21 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Males or females aged 55-80 years.
* MoCA score of less than 28.
* Modest deficits (1 SD below population norm) in executive function, memory, processing speed, or working memory based on the 60-minute battery recommended by the NINDS-CSN.
* Speaks and understands English.
* Enrollment in the Cardiac Rehabilitation program at the University Health Network Toronto Rehabilitation Institute.

Exclusion Criteria:

* A history of stroke
* A history of epilepsy
* Uncontrolled asthma (requiring hospitalization or ER visit in the last 3 months by patient report)
* Uncontrolled diabetes (clinical determination)
* Severe hypo/hypertension (clinical determination)
* Uncontrolled hypercholesterolemia (clinical determination)
* Presence of significant medical illnesses (Severely disturbed liver function, Severely disturbed kidney function, Severely disturbed lung function, HIV, HBV and/or HCV infection, Malignant tumors)
* A current neurological condition (Parkinson's disease, Multiple sclerosis, Significant traumatic brain injury)
* Major psychiatric condition (Current major depressive disorder, Schizophrenia, Bipolar disorder, Substance use disorder (alcohol abuse, heavy smoking (20 cigarettes or more/day))
* Contraindication to MRI or MRS (e.g. metal in body, pacemaker).
* Contraindication to NAC (documented allergy) or allergy to lactose.
* Daily Nitroglycerin use.
* Bleeding disorders (e.g. hemophilia, Thrombotic Thrombocytopenic Purpura) and/or elective surgery within 30 days.
* Volunteers who currently participate in another pharmacological study.
Fruquintinib and Pirfenidone in Combination With Anti-PD-1 Antibody in Advanced or Metastatic pMMR/MSS Colorectal Carcinoma

The purpose of this study is to evaluate the efficacy and safety of fruquintinib and pirfenidone in combination with anti-PD-1 antibody in patients with standard treatment failure of advanced or metastatic pMMR/MSS colorectal adenocarcinoma.

In this study, we explored the potential effectiveness of fruquintinib and pirfenidone in combination with anti-PD-1 antibody, in MSS/pMMR unresectable locally advanced or metastatic colorectal cancer patients who failed standard chemotherapy and testified this new combination in preclinical models. 25 patients were included.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed diagnosis of unresectable locally advanced, recurrent or metastatic colorectal adenocarcinoma.
2. Tumor tissues were identified as mismatch repair-proficient (pMMR) by immunohistochemistry (IHC) method or microsatellite stability (MSS) by polymerase chain reaction (PCR).
3. Subjects must have failed at least two lines of prior treatment.
4. Subjects must have one measurable lesion according to RECIST v1.1 at least.
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 6. 18-75 years old.

7. Life expectancy of at least 12 weeks. 8. Adequate bone marrow, liver, renal and coagulation function as assessed by the laboratory required by protocol

Exclusion Criteria:

1. Previously received anti-programmed death-1 (PD-1) or its ligand (PD-L1) antibody or Pirfenidone.
2. Received last dose of anti-tumor therapy (chemotherapy, targeted therapy, tumor immunotherapy or arterial embolization) within 3 weeks of the first dose of study medication.
3. Received radiotherapy with 4 weeks of the first dose of study medication.
4. Underwent major operation within 4 weeks of the first dose of study medication or open wound, ulcer or fracture.
5. Known symptomatic central nervous system (CNS) metastasis and/or carcinomatous meningitis. Subjects received prior treatment and have stable disease more than 4 weeks from first dose of study medication are permitted to enroll.
6. Active, known or suspected autoimmune disease or has a history of the disease within the last 2 years.
7. Interstitial lung disease requiring corticosteroids.
8. Active or poorly controlled serious infections.
9. Significant malnutrition.
10. Symptomatic congestive heart failure (NYHA Class II-IV) or symptomatic or poorly controlled arrhythmia.
11. Uncontrolled hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg) despite standard treatment.
12. Within 6 months prior to the enrollment, history of gastrointestinal perforation and/or fistula, gastrointestinal ulcer, bowel obstruction, extensive bowel resection, Crohn\&#39;s disease, or ulcerative colitis, intra-abdominal abscesses, or long-term chronic diarrhea.
13. History or evidence of inherited bleeding diathesis or coagulopathy or thrombus
14. Any life-threatening bleeding within 3 months prior to the enrollment.
15. High risk of bleeding.
Comparison of the Gastric Acid Suppressive Effects of Esomeprazole and Generic Omeprazole

Proton pump inhibitors (PPI) are used to decrease stomach acid secretion. A generic form of omeprazole, one of the PPIs, is on the market. With cheaper than brand name PPIs, it is unclear whether generic omeprazole is as effective clinically. This study compares generic omeprazole with half-dose esomeprazole, the strongest brand name PPI. The half-dose esomeprazole is in fact cheaper than generic omeprazole. Healthy volunteers will take each medication in turn for 7 days and their stomach acid will be measured while taking each medication. We hypothesize that half-dose esomeprazole is better at suppressing stomach acid than generic omeprazole.


Eligibility Criteria:
Inclusion Criteria:

* healthy, non-smoking volunteers older than 18 years of age

Exclusion Criteria:

* history of gastrointestinal disease
* known infection
* previous eradication of Helicobacter pylori
* any prescription or over the counter antacid medication
* pregnant and lactating women
Double-blind and Placebo-controlled Study on Intervention Effect of Medium and Long Chain Fatty Acid Triglyceride on Glycolipid Homeostasis in Patients With Metabolic Syndrome and Mechanisms

Double-blind and placebo-controlled study on intervention effect of medium and long chain fatty acid triglyceride on glycolipid homeostasis in patients with metabolic syndrome and mechanisms


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed metabolic syndrome according to IDF diagnostic criteria;
* Rarely eating out of home;
* Aged between 40 and 70 years.

Exclusion Criteria:

* Breastfeeding or pregnancy;
* History of heart disease, coronary heart disease, stroke, cerebral infarction, viral liver disease (hepatitis A, hepatitis B, etc.), chronic kidney disease (GFR\<60 ml/min) or cancer;
* Diabetic ketoacidosis or hyperketosis;
* Drug use has changed in the past six months;
* Taking insulin;
* Used MLCT edible oil in the past six months;
* Have participated in other clinical trials in the last three months.
Triglyceride Rich Lipoproteins and Platelet Activation in Type 2 Diabetes

To investigate in vitro the effect of triglyceride rich lipoproteins (TGRL) obtained in type 2 diabetic women in the fasting state and following a randomized isocaloric lipid rich breakfast on control human platelets

Randomized Comparison of butter versus chocolate spread in 2 groups of 15 patients


Eligibility Criteria:
Inclusion Criteria:

* Menopausal women
* HbA1c ≥6,5 ou ≤10%
* 27 ≤ BMI ≤40 kg/m2

Exclusion Criteria:

* Insulin therapy
* fibrates or Omega 3 fatty acids supplements
* Hormonal replacement therapy of menopause
* Glycemia \> 16 mmol/l
* Alcohol abuse (≥3 Unit/day)
* Special dietary habits
* History of bariatric surgery
Pregnancy Registry in Mali

This registry will assess pregnancy outcomes through demographic surveillance and prospective data collection at a health facility in Kalifabougou, Mali.

This pregnancy registry will gather background data on pregnancy rates and outcomes as well as infant health data to inform future implementation of clinical trials testing monoclonal antibodies (mAbs) to prevent malaria in pregnancy.

In the first part of the study (Community Census Cohort), women of child-bearing age (WOCBA) in the community will be identified and followed for up to 3 years to detect pregnancy at all stages. Upon detection of pregnancy, these women may then transition to participation in the Health Facility Cohort.

In the second part of the study (Health Facility Cohort), data will be prospectively collected from pregnant women presenting at the health facility for antenatal care (ANC) visits or referred in from the Community Census Cohort. The pregnant women will be followed through pregnancy outcome and until 12 months postpartum, and their infant(s) will be followed until 12 months of age.

The study team will collect baseline information in a systematic manner on early pregnancy events, pregnancy and postpartum complications and outcomes, utilization of existing malaria prevention tools, malaria infections and clinical disease, birth outcomes, and follow-up of subsequent offspring.

Eligibility Criteria:
Inclusion Criteria:

Community Census Cohort:

1. Females of childbearing potential or pregnant females.
2. Aged 15 to 49 years.
3. Able to provide verbal individual informed consent.

Health Facility Cohort:

1. Pregnant females 15 to 49 years and their subsequent offspring.
2. Resides in or in the health catchment area of Kalifabougou and willing to return to the health center for Antenatal Care (ANC) visits.
3. Able to provide written individual informed consent for herself and her future offspring(s).

Exclusion Criteria:

Community Census Cohort:

1. Temporary residence in the study area.
2. Other condition(s) that, in the opinion of the investigator, would jeopardize the safety or rights of an individual participating in the study, interfere with the evaluation of the study objectives, or render the participant unable to comply with the protocol.

Health Facility Cohort:

1. Temporary residence in the study area.
2. Other condition(s) that, in the opinion of the investigator, would jeopardize the safety or rights of an individual participating in the study, interfere with the evaluation of the study objectives, or render the participant unable to comply with the protocol.
Study Comparing Product 0405 to a Vehicle Control in the Treatment of Mild to Moderate Atopic Dermatitis in Pediatric Subjects

The purpose of this study is to evaluate the safety and efficacy of product 0405 in pediatric subjects with Mild to Moderate Atopic Dermatitis.

Treatment medication will be administered topically twice daily for 28 days

Eligibility Criteria:
Inclusion Criteria:

* Clinical Diagnosis of Atopic Dermatitis
* Good health with the exception of Atopic Dermatitis
* Percent body surface area minimum requirements

Exclusion Criteria:

* Subjects who are pregnant, nursing or planning a pregnancy
Efficacy Study of Robotic Surgery for Rectal Cancer

After introducing minimally invasive surgery, robotic surgery has been increasingly used in colorectal cancer. However, there is a few prospective study for robotic surgery. The aim of this trial is to evaluate the effectiveness and safety of robotic surgery in mid or low rectal cancer.

This study was designed as randomized phase II trial (laparoscopic versus robotic). The primary end point is quality of mesorectal excision.

Eligibility Criteria:
Inclusion Criteria:

* mid or low rectal cancer (within 9cm from anal verge)
* pathologically proven as adenocarcinoma
* written informed consent
* no severe functional disability in lung and heart

Exclusion Criteria:

* invading adjacent organ
* distant metastasis (lung, liver, brain, bone, distant lymph nodes etc.)
* lateral pelvic lymph node metastasis
* Have severe concomitant disease that might limit compliance or completion of the protocol.
* Have any other malignancy that might impact 5-year survival or might be potentially confused with rectal cancer.
* If female, be pregnant or breast feeding.
* Hereditary colorectal cancer (HNPCC, FAP etc)
* emergency operation
Dose Exploration of Ciprofol for Sedation in Gastrointestinal Endoscopic Diagnosis and Treatment of Obese Patients.

Ciprofol is a new anesthetic, which combines with γ- Aminobutyric acid-a (GABAA) receptor. Ciprofol has shown equivalent anesthetic efficacy of propofol at 1/4 to 1/5 of the dosage. Ciprofol has the pharmacodynamic characteristics of rapid onset, stable and rapid recovery. Phase III clinical results showed that the incidence of injection pain and respiratory and circulatory depression of ciprofol was lower than that of propofol. Therefore, ciprofol has a good application prospect in sedation for gastrointestinal endoscopy, especially for obese patients. In the current study, we would explore the proper dose of Ciprofol in sedated gastrointestinal endoscopy in obese patients.


Eligibility Criteria:
Inclusion Criteria:

1. Age, ≤18 and ≤60 years, no gender limit
2. Undergoing routine gastrointestinal endoscopic diagnosis and treatment
3. American Society of Anesthesiologists (ASA) classification I-II
4. Body Mass Index(BMI) ≥28kg/m\^2
5. Clearly understand and voluntarily participate in the study; provide signed informed consent

Exclusion Criteria:

1. Unhealthy alcohol drinking, defined by more than three standard drinks per day (≈10 g alcohol , equivalent to 50 g of strong Chinese spirits)
2. Drug abuse history within 3 months before the screening period
3. People who are known to be allergic to eggs, bean products, opioids and other drugs, propofol, etc
4. The researcher believes that patients should not participate in this trial
Tislelizumab as Cross-line Treatment for Advanced NSCLC

This study is a single-arm, prospective, open phase II clinical study, exploring the efficacy and safety for advanced non-small cell lung cancer after progression of first-line Tislelizumab combined with chemotherapy and continuing Tislelizumab in combination with docetaxel. The primary study endpoint of this study is measured by progression-free survival (PFS).

1. Tislelizumab: The recommended dose is 200 mg/dose administered every three weeks on the first day of each cycle.
2. Docetaxel: 60-75 mg/m2 every 3 weeks, administered on day 1 of each cycle.
3. Treatment cycle: Tislelizumab in combination with docetaxel until the development of PD, unacceptable toxicities, withdrawal of informed consent, end of study, lost to follow-up, or death, whichever occurs first.


Eligibility Criteria:
Inclusion Criteria:

1. Advanced non-small cell lung cancer diagnosed by histology or pathology, and has progressed after first-line treatment with tislelizumab combined with platinum-containing dual-drug chemotherapy
2. Patients who have progressed after first-line tislelizumab treatment for more than 3 months
3. No EGFR, ALK gene mutations (the genetic test is not required for patients with lung squamous cell carcinoma)
4. At least one measurable lesion (RECIST standard version 1.1)
5. The expected survival period is ≥3 months
6. The ECOG-PS score is 0-2 points

Exclusion Criteria:

1. The tumor histology or cytology is confirmed to be mixed adenosquamous carcinoma or combined with small cell lung cancer
2. Known or suspected active autoimmune diseases
3. A history of immunodeficiency or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation and history of allogeneic bone marrow transplantation
4. Interstitial lung disease, drug-induced pneumonia, radiation pneumonia requiring steroid therapy or clinical symptoms, active pneumonia or severe lung dysfunction
5. Symptomatic brain metastases
6. Those who are known or suspected to be allergic to test drugs and their excipients
7. Women who are pregnant or breastfeeding
Role of the IL33/Amphiregulin Pathway as a Potential Therapeutic Target in HIV Infection

Interleukin33 organize local immune reactions, especially at epithelial barriers.

ST2 is the IL33 receptor. The sST2 rate is higher for patient living with HIV and is an independent predictable factor of mortality. Interleukin33 induce tissue Treg ST2+ lymphocytes proliferation and amphireguline production. Amphireguline is member of epithelial growth factors family, which contributes to tissue repair, and fibrose. Amphireguline also helps immunosuppressives functions. Targetting amphiregulin for people living with HIV who has poor restauration of LTCD4+ could be a future therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Group 1: HIV-infected subjects

   * HIV-1 infection
   * Age ≥ 18 years old
   * CD4 count≥ 100/mm3
   * Receiving an active antiretroviral treatment (plasma HIV viral load ≤ 50 copies/ml)
   * Subjects needing an STI screening for routine care including rectal biopsy (independently of the current study protocol)

   NB : an additional inclusion criteria for the Group 1 will be defined after the "phase 0" which will define two levels of fibrosis (low / high)
2. Group 2: controls not infected with HIV needing a rectoscopy for an STI screening

   * HIV negative
   * Age ≥ 18 years old
   * Subjects needing an STI screening for routine care including rectal biopsy (independently of the current study protocol)
3. Group 3: controls not infected with HIV needing a colonoscopy

   * HIV negative
   * Age ≥ 18 years old
   * Subjects needing a colonoscopy with colorectal biopsy as part of routine care (independently of the current study protocol)

For the 3 groups:

Inclusion criteria

* Affiliated or beneficiary of a Social Security coverage
* Free, informed and written consent, signed by the participant and the investigator (at the latest on the day of pre-inclusion and before any examination carried out within the framework of the trial)

Exclusion Criteria for the 3 groups

* - HIV-2 infection or HIV-1 \& HIV-2 co-infection
* Active infection or cancer
* Contraindication to rectal biopsies (coagulation disorders, anticoagulation therapy, anorectal surgery, inflammatory bowel disease, post-radial rectitis)
* Subject participating in another research evaluating other treatments with an exclusion period ongoing at the screening visit.
* Person under legal guardianship or deprived of liberty by a judicial or administrative decision.
* Pregnant or breastfeeding women
* Replicative HCV or HBV infection
Observational Study With Neupro® to Evaluate the Patient´s Perception of Pain Associated With Parkinson´s Disease

The primary objective of this study is to evaluate the perception of pain associated with Parkinson´s Disease in patients who receive Neupro® for the first time.


Eligibility Criteria:
Inclusion Criteria:

* The decision by the treating physician to treat a patient with Neupro® for the first time is made before the patient's participation in this Non-Interventional Study (NIS)
* A Patient Data Consent form is signed and dated by the patient
* Male and female patients that suffer from pain associated with idiopathic Parkinson's Disease according to the physician's assessment
* Patients have not been treated with Rotigotine in the past