cyrilzakka/clinical-trials huggingface dataset:
Arsenic Trioxide in Treating Patients With Stage IVB or Recurrent Cervical Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have stage IVB or recurrent cervical cancer.

OBJECTIVES:

* Evaluate the efficacy of arsenic trioxide in patients with stage IVB or recurrent cervical carcinoma.
* Determine the safety of this treatment in these patients.

OUTLINE: Patients receive arsenic trioxide IV over 1-4 hours on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study over 10-19 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed stage IVB or recurrent cervical carcinoma that is not amenable to standard curative therapies

  * Squamous carcinoma OR
  * Adenocarcinoma
* Measurable disease

  * At least 20 mm by conventional techniques OR
  * At least 10 mm by spiral CT scan
  * Nonmeasurable disease defined as any of the following:

    * Bone disease
    * Leptomeningeal disease
    * Ascites
    * Pleural/pericardial effusion
    * Inflammatory breast disease
    * Lymphangitis cutis/pulmonis
    * Abdominal masses not confirmed or followed by imaging techniques
    * Cystic lesions
* No active brain metastases

PATIENT CHARACTERISTICS:

Age:

* 17 and over

Performance status:

* Karnofsky 60-100%

Life expectancy:

* Greater than 3 months

Hematopoietic:

* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST and ALT no greater than 2.5 times ULN

Renal:

* Creatinine no greater than 2.0 mg/dL OR
* Creatinine clearance at least 50 mL/min

Cardiovascular:

* No cardiac arrhythmias, unstable angina, or conduction abnormalities
* No New York Heart Association class III or IV heart disease or clinical evidence of congestive heart failure
* Pretreatment QTc less than 500 msec

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 4 months after study
* No grade 3 or greater neurologic abnormalities
* No history of seizures
* No concurrent uncontrolled active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No more than 2 prior therapies for advanced disease

Chemotherapy:

* No more than 2 prior therapies for advanced disease
* At least 4 weeks since prior chemotherapy

Endocrine therapy:

* No more than 2 prior therapies for advanced disease

Radiotherapy:

* No more than 2 prior therapies for advanced disease
* At least 4 weeks since prior radiotherapy

Surgery:

* Not specified

Other:

* At least 4 weeks since prior cytotoxic therapy or investigational agents
An Observational Study of Lumosity in Seniors

The primary objective of this observational study is to determine performance characteristics and usability of Lumosity and the Brain Performance Test in a group of older adult volunteers.

Approximately 200 prospective users currently will be provided free 6-month premium access Lumosity accounts. Participants will be provided with an account activation code and instructed on how to sign up for Lumosity with their email address. They will be subject to the Lumosity Terms of Service and follow the typical user experience. Upon creating an account, users would be asked to complete a short demographic survey that includes questions on gender, education, occupation, years since retirement, health, computer familiarity, and perceptions of brain training.

Those who sign up will have immediate access to the Lumosity training system and the entire suite of Lumosity games. In addition, they will be invited, via email, to take the Brain Performance Test one week after the initial sign-up and then again 12 weeks later. Approximately every 8 weeks, users will be asked to complete a short questionnaire about their experience with Lumosity. This questionnaire will be accessed via email. Participants will be asked to train 5 days a week for 20-30 minutes per day, but are free to play as much or a little as they choose. Community associates at the sites will be encouraged to host group training sessions, giving the seniors a chance to gather and complete their training together, share their experiences, and get any help they may need. In addition, sites will have the option of hosting 1-2 focus groups with participants and researchers from Lumos Labs. The focus groups will be an opportunity to give and receive direct feedback about Lumosity, and get any questions answered by the researchers.

Eligibility Criteria:
Inclusion Criteria:

Participants must meet the following criteria:

1. 55 years of age or older
2. English-speaker
3. Cognitively stable (i.e., without a known diagnosis that may affect cognitive abilities)
4. Regular access to and ability to use a computer or mobile device with Internet connectivity.

Exclusion Criteria:

1. Under 55 years of age
2. Have a current diagnosed cognitive or neuropsychological condition
3. Are taking medication that may impede cognitive functioning
4. Anticipate a dosage change in medication that may affect cognitive functioning during the course of the study (24 weeks)
5. Have other conditions or problems that may preclude regular computer usage
Physician Reasoning on Diagnostic Cases With Large Language Models

This study will evaluate the effect of providing access to GPT-4, a large language model, compared to traditional diagnostic decision support tools on performance on case-based diagnostic reasoning tasks.

Artificial intelligence (AI) technologies, specifically advanced large language models like OpenAI's ChatGPT, have the potential to improve medical decision-making. Although ChatGPT-4 was not developed for its use in medical-specific applications, it has demonstrated promise in various healthcare contexts, including medical note-writing, addressing patient inquiries, and facilitating medical consultation. However, little is known about how ChatGPT augments the clinical reasoning abilities of clinicians.

Clinical reasoning is a complex process involving pattern recognition, knowledge application, and probabilistic reasoning. Integrating AI tools like ChatGPT-4 into physician workflows could potentially help reduce clinician workload and decrease the likelihood of missed diagnoses. However, ChatGPT-4 was not developed for the purpose of clinical reasoning nor has it been validated for this purpose. Further, it may be subject to disinformation, including convincing confabulations that may mislead clinicians. If clinicians misuse this tool, it may not improve diagnostic reasoning and could even cause harm. Therefore, it is important to study how clinicians use large language models to augment clinical reasoning prior to routine incorporation into patient care.

In this study, we will randomize participants to answer diagnostic cases with or without access to ChatGPT-4. The participants will be asked to give three differential diagnoses for each case, with supporting and opposing findings for each diagnosis. Additionally they will be asked to provide their top diagnosis along with next diagnostic steps. Answers will be graded by independent reviewers blinded to treatment assignment.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be licensed physicians and have completed at least post-graduate year 2 (PGY2) of medical training.
* Training in Internal medicine, family medicine, or emergency medicine.

Exclusion Criteria:

* Not currently practicing clinically.
Study of Epigallocatechin-3-gallate (EGCG) for Esophagus Protection in Patients With Lung Cancer Receiving Radial Radiotherapy

The investigators conducted this phase II study of EGCG therapy protection of the esophagus from damage induced by radiotherapy. In order to observe the effectiveness of EGCG, esophageal toxicity was recorded weekly using a grading scale based on symptomatology, following the Radiation Therapy Oncology Group (RTOG) scoring system. Patient-reported pain related to esophagitis was measured using the numerical rating scale (NRS) every week from EGCG application to 2 weeks after the end of radiotherapy. The scales are translated into Chinese and guides in Chinese are developed instructing how to use the scales and perform the assessments.


Eligibility Criteria:
Inclusion Criteria:

* pathologically documented LC
* considered medically inoperable stage IIIA or stage IIIB or limited stage small cell lung cancer
* age ≥18 years
* Karnofsky ≥70
* adequate hematologic, hepatic and renal function
* FEV1 \> 800 cc
* mean esophagus dose \>20 Gy

Exclusion criteria were as follows:

* a known allergy or hypersensitivity to EGCG
* pregnancy or lactation
* prior radiation to the thorax
Clinical Characterization and Outcome of Anti-IgLON5 Disease

Anti-IgLON5 disease is a neurological disorder associated with antibodies to IgLON5, a neuronal cell adhesion protein of unknown function. Most patients develop a combination of significant sleep disturbances (non-rapid eye movement (NREM) and rapid eye movement parasomnias with obstructive sleep apnoea), bulbar dysfunction (dysarthria, dysphagia, vocal cord paralysis or episodes of respiratory failure) and gait instability. Early autopsy studies showed deposits of phosphorylated tau protein mainly in neurons of the brainstem tegmentum, suggesting a primary neurodegenerative disease. However, the results of subsequent studies have provided increasing support for an immune-mediated pathogenesis. First, there is a strong association with the human leukocyte antigen (HLA) haplotype DRB1\*10:01-DQB1\*05 : 01, which is present in \~60% of patients (compared to 2% in the normal population); secondly, recent autopsy studies have shown the absence of abnormal tau deposits; and thirdly, in live neurons in culture, IgLON5 antibodies cause irreversible loss of surface IgLON5 clusters and cytoskeletal changes such as dystrophic neurites and axonal bulges. Together, these studies suggest that antibody-mediated disruption of IgLON5 function leads to neurofilament and cytoskeletal alterations that can potentially result in tau accumulation.

Over the last two years, an increase in diagnoses of anti-IgLON5 disease has been observed in the French Reference centre of Autoimmune Encephalitis. This could be related to a better knowledge of the disease, or to other yet unknown factors. Clinical characterisation of these patients is essential to understand the underlying reasons for the increase in diagnoses and to improve knowledge of this disease. Furthermore, the response of these patients to immunosuppressive drugs and the long-term prognosis remain unknown.


Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 ans
* Anti-IgLON5 antibody positivity

Exclusion Criteria:

- Lack of clinical data
Safety and Immunogenicity Study of Traveler's Diarrhea Vaccine Patch

The purpose of this study is to evaluate and compare the safety and immune responses following a two vaccination regimen by transcutaneous immunization with heat-labile enterotoxin of E. coli (LT) patches or Placebo, with or without alcohol swabbing


Eligibility Criteria:
Inclusion Criteria:

1. A female or male 18-64 (inclusive) years of age;
2. In good health as determined by medical history and screening exam;
3. Females who are post-menopausal, surgically sterile, or have a negative serum/urine pregnancy test at Day 0 and agree not to become pregnant for the duration of study.

Exclusion Criteria:

1. Abnormalities at physical exam \[as determined by the Toxicity Grading Scale (Grade 1-4)\];
2. Laboratory abnormalities \[as determined by the Toxicity Grading Scale (Grade 1 4)\] at screening;
3. Participated in research involving investigational product within 30 days before planned date of first vaccination;
4. Ever received investigational enterotoxigenic E. coli, LT, or LT (R192G) or NasalFlu, Berna Biotech, Ltd;
5. Women who are pregnant or breastfeeding;
6. Clinically significant underlying enteric, pulmonary, cardiac or renal disease;
7. Current seizure disorder;
8. Current use of immunosuppressive therapy (inhaled steroids are allowed);
9. Known or suspected alcohol abuse or illicit drug use within the last year;
10. Positive Serology for HIV-1, HIV-2, HbsAg, or HCV;
11. Known allergies to any component of the vaccine including adhesives;
12. An employee of the study site;
13. An employee of Intercell (global) or an immediate family member;
14. Visible tattoos or marks (tattoos/scars) at the vaccination areas that would prevent appropriate dermatologic monitoring of the vaccination sites;
15. Receipt of any routine vaccinations within 7 days prior to, or following, the date of planned study vaccinations.
Trial Evaluating the Interest of Noninvasive Ventilation in NAVA Mode in Respiratory Decompensations Children With Infantile Spinal Muscular Atrophy Type II

The new NAVA® ventilatory mode with the SERVO-i ventilator (Maquet®) uses the electrical activity of the diaphragm (EADi) as a marker for triggering the respiratory cycle. The EADi is captured by the electrodes of a specific catheter (the Edi® catheter) placed in the esophagus as a regular gastric feeding tube, and relayed to the SERVO-i who displays it and delivers respiratory assistance according to measured Edi signal which allows synchronous assistance, proportional to the respiratory efforts of the patient.

To date, no measure of the effectiveness of NAVA NAV has been performed in children with neuromuscular pathology whereas this technique could reduce the use of invasive ventilation, very iatrogenic in these fragile subjects.

This is a prospective, interventional, sequential, open-label research involving ASI II children with acute respiratory decompensation requiring ventilatory support by NIV. Airway pressure, transcutaneous CO2 monitoring and hemodynamic parameters will be recorded continuously during the study, after inclusion of the patient.

Eligibility Criteria:
Inclusion Criteria:

* Age above 1 year and under 18 years
* Patient hospitalized in the pediatric intensive care unit.
* Acute respiratory decompensation requiring non-invasive ventilation for more than 6 hours.
* Patient with traditional NIV support less than 12 hours and still showing an indication for a non-invasive ventilatory support.
* Affiliation to the French health insurance organism
* Consent signed by the two holders of parental authority for the child participation in the research.

Exclusion Criteria:

* Contraindications to the use of NAVA or the setting up of a nasogastric tube.
* Hemodynamic instability requiring the use of vasopressor amines, adrenaline, norepinephrine or dobutamine.
* Severe respiratory instability requiring imminent intubation or FiO2\> 60%, or PaCO2\> 80 mmHg.
* Limitation of life support treatments discussed or decided.
Efficacy Analysis of Neoadjuvant Treatment in Lung Cancer Using Low-dose Nivolumab Combined With Chemotherapy

The primary objective of this study is to assess the major pathological response (MPR) rate and pathologic complete response (pCR) rate in stage IB-IIIA non-small cell lung cancer (NSCLC) treated with a low dose of neoadjuvant immunotherapy combined with platinum doublet.


Eligibility Criteria:
Inclusion Criteria:

* Able to provide a signed Informed Consent Form (ICF), indicating agreement to comply with the requirements and restrictions in the ICF and protocol.
* Male or female, aged 18 years or older.
* Diagnosed with non-small cell lung cancer (NSCLC) with clinical staging IB, II, or IIIA.
* Receiving treatment at Hospital de Base.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment, with no decline from two weeks prior to the baseline period or the day of the first dose.
* Tumor sample meets the following requirements:
* Negative for EGFR gene expression.
* Negative for ALK and ROS1 protein expression.
* PD-L1 protein expression documented and assessable.
* Tumor is considered resectable upon initial assessment by three thoracic oncology surgeons (IR, CM, and HN) following a multidisciplinary review.
* Adequate organ and bone marrow function as defined below:
* Hemoglobin: ≥ 9.0 g/dL\*
* Absolute neutrophil count: ≥ 1.5 × 10\^9 /L\*
* Platelet count: ≥ 100 × 10\^9 /L\*
* \*Note: Granulocyte colony-stimulating factor (G-CSF), platelet transfusions, and blood transfusions are not permitted to meet these values.
* Serum bilirubin: ≤ 1.5 × upper limit of normal (ULN), except for participants with confirmed Gilbert syndrome, who may be included upon physician consultation.
* ALT and AST: ≤ 2.5 × ULN.
* Creatinine clearance: ≥ 50 mL/min (calculated using the Cockcroft and Gault formula).
* Life expectancy greater than six months prior to randomization.

Exclusion Criteria:

* Refusal to sign the Informed Consent Form (ICF).
* NSCLC clinical stages IA, IIIB N3, IIIC, IVA, and IVB.
* Tumors with T4 invasion of the aorta, esophagus, and/or heart; or presence of bulky N2 disease.
* Tumor deemed unresectable.
* Prior systemic anticancer therapy for NSCLC, including chemotherapy, biologic therapy, immunotherapy, or any investigational drugs.
* History of another primary malignancy, with exceptions for:
* Malignancies treated with curative intent and no active disease for ≥ 2 years before the first dose of investigational product (IP) and with a low risk of recurrence.
* Adequately treated non-melanoma skin cancer or lentigo maligna with no evidence of disease.
* Adequately treated carcinoma in situ with no evidence of disease.
* Incomplete basic medical information in the electronic medical record.
* Positive for EGFR gene expression.
* Positive for ALK protein expression.
* No available data on PD-L1 protein expression.
* Positive for ROS1 protein expression.
* Pregnant or breastfeeding at the time of enrollment.
The Effect of Schroth Method on Pain, Body Awareness and Quality of Life in Adolescent Individuals With Idiopathic Scoliosis

This study was aimed to compare the effect of Schroth therapy method, which is a 3-dimensional scoliosis exercise method, and traditional exercises on pain, body awareness and quality of life in young individuals with idiopathic scoliosis.

38 individuals aged between 10-18 with the diagnosis of idiopathic scoliosis will be participated in the study. Individuals (study group) underwent 1 hour exercise program 3 times a week for 6 weeks, and the individuals (control group) undervent a traditional exercise program once a week under supervision of physiotherapist for 6 weeks. During the rest of the week, same exercise program was given as a home program for at least half an hour a day and individuals will followed up. Individuals' subjective pain intensity will be assessed with Visual Analogue Scale (VAS), pressure pain threshold by algometer, body awareness by Turkish version of Body Awareness Questionnaire and quality of life by Turkish version of Scoliosis Research Society (SRS)-22 scale. Measurements will be performed before and after the 6-week exercise program.

Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with idiopathic scoliosis by a specialist physician,
* Between the ages of 10-18,
* Primary curvature between 20-40 degrees according to the Cobb method,
* Having C or S type of scoliosis,
* Having back / low-back pain due to scoliosis,
* Those who have not received any previous exercise therapy for scoliosis,
* Volunteering to participate in the study,
* Having the cognitive capacity to cooperate with the directions of the physiotherapist,
* Has not suffered any injuries to the musculoskeletal system in the last 6 months,
* No neurological, orthopedic or cardiopulmonary disorders other than scoliosis diagnosis,
* Young individuals who have not undergone any surgery related to the diagnosis of scoliosis

Exclusion Criteria:

* Previous spinal surgery,
* Any disease other than idiopathic scoliosis,
* Individuals who cannot adapt to the directions of the physiotherapist and cannot fulfill the requirements of the exercise program
SB17170 Phase1 Trial in Healthy Volunteer

This clinical trial aims to learn about the safety, tolerability, and pharmacokinetic properties of SB17170 and its active metabolite SB1703 in single and multiple oral administration in healthy adults.

The main questions it aims to answer are the safety, tolerability, and PK characteristics of SB17170 in healthy adults.

This clinical trial aims to learn about the safety, tolerability, and Pharmacokinetic properties of SB17170 and its active metabolite SB1703 in single and multiple oral administration in healthy adults.

The main questions it aims to answer are the safety, tolerability, and PK characteristics of SB17170 in healthy adults.

The second questions are

* To explore biomarkers and evaluate pharmacodynamic properties with ex-vivo test and proteome assay for SB17170
* To evaluate the effects of ethnic differences on the safety, tolerability, and pharmacokinetic properties of SB17170 in healthy Korean and Caucasian adults.
* To evaluate the effect of food between Fast and high-fat meals on safety, tolerability, and pharmacokinetic properties of SB17170 in healthy adults.

The difference between SB17170 and placebo on safety, tolerability, and PK/PD properties will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Korean or Caucasian adults between the ages of 19 and 50 as of the date of written consent
* Subjects with a body weight of 55.0 kg or more at the time of screening and a body mass index (BMI) of 18.0 kg/m2 or more and less than 30.0 kg/m2
* Written informed consent

Exclusion Criteria:

* Clinical significant medical history
* Gastrointestinal disease or past history
* Hypersensitivity or clinically significant hypersensitivity to the components of investigational drugs
* Screening test AST, ALT \> ULN x 1.5 Creatinine clearance \< 60mL/min/1.73m2 QTcB interval \> 450 ms Serologic test positive(Hepatitis B, Hepatitis C, HIV)
* SBP \<90 mmHg or \>150 mmHg, DBP \<60 mmHg or \> 100 mmHg
* Drub abuse history
* Administration of any OTC drug, Herbal drug, Investigational medication within 2weeks
* Participation in other clinical trial within 6 months
Mindfulness Intervention For Child Abuse Survivors (MICAS)

The purpose of this study is to assess the effect of meditation training called Mindfulness-Based Stress Reduction on reducing the symptoms of psychological distress among adult survivors of child abuse.

The specific aims of the project are:

1. To determine whether Mindfulness- Based Stress Reduction program is associated with a reduction in symptoms of depression, anxiety, and psychological distress.
2. To assess indications of efficacy, assess feasibility of enrollment and compliance among this patient population
3. Provide pilot data that can be used to apply for larger grants to more fully develop this approach

Eligibility Criteria:
Inclusion Criteria:

* A history of child abuse, as attested by the potential participant
* Currently in therapy with a licensed psychotherapist (psychiatrist, psychologist, social worker).
* Plans to remain in therapy with a licensed psychotherapist (psychiatrist, psychologist, social worker) for the duration of the study.
* Recommendation made by the potential participant's licensed psychotherapist (psychiatrist, psychologist, social worker) the Mindfulness-Based Stress Reduction program would be an appropriate adjunct therapy for his or her client.
* Score of 0.50 or higher on the General Severity Index of the Brief Symptom Inventory, indicating psychological distress above the normal population.
* Aged 21 or above.
* Ability to read and write English.
* Able to attend 10 courses and assessment visits over a 6-week period.
* Willing to practice skills for 20-30 minutes per day 6 days a week, during the course.

Exclusion Criteria:

* Major psychiatric illness (bipolar disorder, schizophrenia, dissociative identity disorder, or others).
* Active alcoholism or drug dependency.
* Any psychological or physical illness the investigator feels would prohibit full participation in the course.
* Currently enrolled in another clinical trial.