cyrilzakka/clinical-trials huggingface dataset:
Real-time Engagement for Learning to Effectively Control Type 2 Diabetes

This is a clinical trial that includes a run-in period, a 90 day micro-randomized trial, and a 90-day observational period. The goal of this study is to evaluate whether providing paired real time glycemic and health behavior data in a smartphone app leads to better glycemic control among adolescents and young adults with T2D. Glycemic control will be monitored using Continuous Glucose Monitors (CGM), and health behavior data will be collected via a Fitbit activity tracker and a research app (Healthmine). Participants will be prompted to view and reflect on glycemic trends and health behavior data (Fitbit data, logging of diet and medication adherence) during the 90-day micro-randomized trial period, then observed for ongoing use of the Healthmine app and engagement with CGM in the following 90-day observation period.

The objective of REFLECT2D (Real-time Engagement For Learning to Effectively Control Type 2 Diabetes) is to evaluate whether pairing real-time glycemic and health behavior data leads to improved glycemic control among adolescents and young adults with type 2 diabetes. Participants will use a mobile app that integrates continuous glucose monitor data, Fitbit activity tracker data, and diet logging, with the aim of increasing capability to interpret glycemic data (including impacts of physical activity and dietary intake), providing opportunity to plan and implement behavior change, and increasing motivation to engage in health behaviors. After a session with a Registered Dietitian and Diabetes Educator who will support participants in forming diet and activity goals, a 90-day micro-randomized trial (MRT) period will involve once daily randomization of each participant to: 1) physical-activity focused prompt, 2) dietary intake-focused prompt, or 3) no prompt. Prompts will include reviews of glycemic trends in the past 24 hours (e.g., periods of hyperglycemia, max glucose) and will ask participants to use visual summaries of activity or diet and glucose to reflect on and revise their behavioral management goals as needed. After the MRT, a 90-day observation period without prompts but with ongoing availability of continuous glucose monitor data, Fitbit, and Healthmine app will examine persistence of glycemic and behavior changes.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes: negative diabetes autoantibodies, no suspicion for monogenic diabetes
* HbA1c ≥7.0%, stable medication use (≥3 months)
* HbA1c 6.0-6.9% without short-acting insulin, any other stable diabetes medication use (≥3 months)
* English-speaking (app in English)

Exclusion Criteria:

* Current pregnancy
* Hydroxyurea use (CGM sensor inaccuracies)
* Cognitive impairment or severe psychiatric condition that could interfere with participation in behavioral intervention for diabetes self-management
* Current or previously diagnosed eating disorder
Measuring Symptom Relief After Radiofrequency Ablation of the Thyroid

The purpose of this study is to measure the impact of thyroid radiofrequency ablation procedure on patients with thyroid-related symptoms using a modified pre-existing scoring system.


Eligibility Criteria:
Inclusion Criteria:

- Undergoing Radiofrequency Ablation (RFA) for symptomatic thyroid nodule(s).

Exclusion Criteria:

- Decline to participate in research.
Gait Rehabilitation to Treat FastOA

The purpose of this study is to determine the effects of real-time gait biofeedback delivered over a 6-week period on early markers of FastOA and conduct 6-week and 6-month follow-up assessments in anterior cruciate ligament reconstructed patients.


Eligibility Criteria:
Inclusion Criteria:

* Have completed all other formal physical therapy
* Are between the ages of 16 and 35
* Underwent an anterior cruciate ligament reconstruction (ACLR) between 6 and 60 months prior to enrollment
* Demonstrate underloading during gait (vGRF- impact peak \<1.12 x BW)

Exclusion Criteria:

* A multiple ligament surgery (i.e., PCL)
* A lower extremity fracture (i.e., displaced tibial plateau fracture)
* Knee osteoarthritis
* The participant has a BMI ≥ 36.
Endoscopic Mucosal Resection and Cellular Matrix

This study is being done to test the usefulness of extracellular matrix (ECM) a thin sheet placed over the site after endoscopic mucosal resection to promote healing of the esophagus.


Eligibility Criteria:
Inclusion Criteria

* Able to provide consent
* Scheduled for standard of care endoscopy that may require initial EMR evaluation of esophageal lesions
* Histological evidence of intestinal metaplasia with dysplasia or intramucosal carcinoma

Exclusion Criteria

* Pregnant women
* Prior esophageal EMR or ESD in the same region
* Anyone unable to provide informed consent
* Medical co-morbidities precluding EGD evaluation
* History of chemoradiotherapy to the neck/esophagus
* Unable to stop anticoagulation therapy (non-steroid anti-inflammatory medications are permissible)
Phase I Nicotinic Agonist Treatment Trial for Autism

This study plans to learn more about whether a nicotine-like investigational new drug, DMXB-A \[3-(2,4-dimethoxybenzylidene) anabaseine\] may have positive effects on mental focus and may help us to find new types of treatment for autism spectrum disorder. Subjects will come in for a screening visit and three more drug visits. There will be at least one week between each drug visit to allow the drug to be eliminated from your system completely. During each drug visit subjects will receive either a placebo (a capsule that looks like medicine but is not real), 75 mg of DMXB-A, or 150 mg of DMXB-A. During the drug day vital signs and well being will be monitored by the study physician. Subjects will complete some paper and pencil tasks to test memory, attention, speed, and problem solving, some rating scales and questionnaires, and the study team will record brain wave patterns with an electroencephalogram (EEG) .


Eligibility Criteria:
Inclusion Criteria:

* age 18-50
* meet DSM-5 criteria for Autism Spectrum Disorder, Levels 1 or 2, as defined by Autism Diagnostic Observation Schedule
* non-smoking persons
* in good health

Exclusion Criteria:

* persons with estimated verbal and nonverbal IQ \< 70.
* abuse of other substances.
* Persons not sufficiently fluent in English to permit testing
* those with history of severe head injury
* Fragile X Syndrome
* Rett Syndrome
The Use of Serratus Block for Cardiac Surgery

The purpose of this randomized, un-blinded study is to determine if serratus blocks or Patient Controlled Analgesia (PCA)-alone (no block) offer patients adequate pain relief. This study will compare two standard of care pain management options and the patients narcotic requirements in the immediate postoperative period.


Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18 years of age undergoing robotic cardiac surgery.

Exclusion Criteria:

* Patients who are not candidates for serratus block
PD-1 Antibody Expressing CAR-T Cells for EGFR Family Member Positive Advanced Solid Tumor

To evaluate the safety and effectiveness of cell therapy using herinCAR-PD1 cells to treat advanced cancer.

Individuals greater than or equal to 18 years of age and less than or equal to 70 years of age who have been diagnosed with relapsed or refractory cancer that has not responded to or has relapsed after standard treatment.

A total of 20 patients may be enrolled over a period of 1-2 years.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18\~80 years old, male or female;
2. Life expectancy≥6 months;
3. ECOG score: 0-2;
4. Advanced Solid Tumor were diagnosed by histology and cytology;
5. Enough venous channel,no other contraindications to the separation and collection of white blood cells;
6. Immunohistochemistry and RT-PCR technology will be used to determine the positive EGFR family (including EGFR, HER2, HER4) and EGFRVIII、IGF1R protein. At least one protein expressed in immunohistochemical tumor tissue should be no less than grade 2 or 2+ scores. The levels of protein are defined as follows: (according to cell staining) : grade 0: without staining; grade 1: 1-25%; grade 2: 26-50% and grade 3: 51-100%; (According to the intensity): negative; 1+; 2+ and 3+;
7. Laboratory examination: white blood cell≥3 x 10\*9/L, blood platelet count≥60 x10\*9/L, hemoglobin≥85g/L; lymphocyte ≥0.7×109/L, total bilirubin less than 2.5 times of the normal level; ALT and AST less than 2.5 times of the normal level; serum creatinine less than 1.5 times of the normal level；
8. Signed informed consent；
9. Women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 4 months following the cells transfusion.
10. Disease progression and the current treatment is invalid.
11. The treatment effect is not ideal after receiving 2 line therapy at least and willing to join in clinical trials

Exclusion Criteria:

1. Expected Overall survival \< 6 months;
2. Patients with uncontrolled hypertension,unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (\> Class II, NYHA), or myocardial infarction within 6 months.
3. Abnormal lung function: FEV (forced expiratory volume) \< 30% prediction, DLCO (diffusing capacity of the lung for carbon monoxide) \< 30% prediction, blood oxygen saturation \< 90%;
4. Other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc;
5. Unable or unwilling to provide informed consent, or fail to comply with the test requirements.
6. Uncontrolled active infection.
7. Serious chronic disease of critical organs such as kidney and liver. Kidney function more than CKD stage I,and liver function less than the Child - Pugh class B;
8. Long-term use or being used of immunosuppressive drugs with autoimmune diseases
9. Glucocorticoid is needed in a long term.
10. Currently (within 30 days) enrolled in another clinical trial.
11. Pregnancy or breastfeeding women.
Diagnosis of Variceal Bleeding and Its Control in Cirrhosis

The aim of the study was to determine the independent predictors of variceal bleeding and control of bleeding in cirrhosis as no scientific assessment have been perfomed until now


Eligibility Criteria:
Inclusion Criteria:

* Cirrhotic patients admitted for an acute complication of cirrhosis
* admission ≤ 6 hours of inclusion

Exclusion Criteria:

* Child-Pugh score \> 13
* Digestive hemorrhage
* Non cirrhotic portal hypertension
Learning Diagnostic Reasoning Through AI

This experiment aims to determine the effect of AI-generated questions and feedback on diagnostic reasoning in preclinical medical students.

Main Research Question:

What is the effect of AI-generated questions and feedback on diagnostic reasoning skills in preclinical medical students?

This study involves a two groups:

1. Intervention Group: Medical students will receive AI-generated questions and feedback related to five abdominal pain diagnoses.
2. Control Group: Medical students will not receive any intervention. Participants in the intervention group will undergo structured learning sessions consisted of AI-generated questions and feedback as a spaced repetition. Control group will not attend these sessions; they only receive their usual medical training.

The diagnostic reasoning performance will be assessed using a video-based Objective Structured Clinical Examination: OSVE (Objective Structured Video Examination) where videos of "patient-doctor encounters are shown to students and questions related to the video clip are asked. Written answers are marked in a standardised manner."

Eligibility Criteria:
Inclusion Criteria:

Medical students in Gazi University Faculty of Medicine

Exclusion Criteria:

Medical students outside Gazi University Faculty of Medicine
Interest of Late Images for the Assessment of Extensions in 18FGD PET-CT of Muscle-Invasive Bladder Cancers

The goal of this study is to demonstrate a significant gain in sensitivity versus surgical curage (extended pelvic) for initial lymph node staging of late FDG-PET images (2.5 hours) versus standard images (1 hour), analyzed by side (right iliac/left iliac areas in Patients with muscle-invasive bladder tumor (MIBT) (≥pT2) referred for FDG-PET in the nuclear medicine department of Hôpital Foch as part of their initial extension workup.

Before performing 18FDG PET-CT, the operator checks that the patient has fasted for at least 6 hours and that blood glucose levels are below 11 mmol/l. In the absence of contraindication, intravenous (IV) injection of the radiopharmaceutical (18FDG at a dose of 3 MBq/kg) and a diuretic (Furosemide 20mg) will be performed as part of routine care. The 18FDG PET-CT scan will be performed in 2 phases:

1st phase: Standard acquisition (vertex to mid-thigh) at 1 hour post-injection of radiotracer. PET acquisition is coupled to a "base-dose" CT scan in spontaneous contrast, for anatomical location, measurement of lymph node size, and creation of an attenuation map, necessary for correction of attenuation and diffusion on PET images (DLP estimated at around 500 mGy.cm on average). Micturition is performed as part of routine care just before the first acquisition.

Phase 2: Complementary abdomino-pelvic acquisition at 2.5 hours post-injection (2 or 3 steps depending on patient size. This second PET acquisition is coupled to an "ultra-base-dose" CT scan in spontaneous contrast, to be used only for attenuation and diffusion correction (DLP estimated at around 100 mGy.cm on average). Micturition is performed 30 minutes before the second acquisition.

The patient's proposed therapeutic management will be decided at the PCR once the extension work-up has been carried out, as part of routine care. For this purpose, only "standard" 18FDG PET-CT images may be used.

As a general rule, patients with distant metastases (stage pT2N+M+) will receive palliative treatment, while surgical treatment from the outset, or after chemotherapy for patients with stage pT2N0M0 or pT2N+M0, will be discussed on a case-by-case basis at the multidisciplinary consultation meeting.

Late" images will be used after lymph node curage, in patients who have not had chemotherapy prior to surgery (cystectomy + extended pelvic lymph node curage), to determine the sensitivity of these complementary images.


Eligibility Criteria:
Inclusion Criteria:

* Patient 18 years of age or older,
* With histologically proven muscle-invasive bladder cancer (≥pT2) at endoscopic bladder resection,
* Scheduled to undergo 18FDG PET-CT in the nuclear medicine department at Hôpital Foch,
* Having signed a consent form,
* Affiliated to a health insurance scheme.

Exclusion Criteria:

* Patient with a history of pelvic or genitourinary cancer,
* Patient with known metastatic disease,
* Patient with a contraindication to 18FDG PET-CT,
* Pregnant or breast-feeding woman,
* Patient deprived of liberty or under guardianship.
Effect of Coaching on Mid-Career Physician Well-Being, Job Satisfaction, and Fulfillment

The study will assess the effect of individualized professional coaching for mid-career family medicine and general internal medicine physicians on burnout, job satisfaction, and professional fulfillment.


Eligibility Criteria:
Inclusion Criteria

1. General internal medicine and family physicians
2. In practice for 5-30 years

Exclusion Criteria:

1. physicians who specialize in areas other than general internal medicine and family medicine
2. physicians who have been in practice less than 5 years or more than 30 years
Clonidine to Prevent Implantable Cardiovertor Defibrillator Firing

Cardiac arrest or sustained VT (ventricular tachycardia) in patients with heart disease is best treated with an ICD (implantable cardioverter defibrillator). However, the ICD alone is not appropriate therapy for patients with frequent VT episodes. In fact frequent shocks for VT may predict a poorer prognosis. Anti-arrhythmic drugs are co-administered with ICDs in up to 50% of patients to prevent VT episodes, but antiarrhythmic drugs may have harmful effects. Thus improved drugs to prevent VT without interfering with ICD function are needed. Recent data including our own suggest that clonidine may be a new therapy to prevent ICD shocks. It may act centrally on sympathetic outflow and peripherally and selectively on cardiac Purkinje, to suppress and control VT occurring in patients. Our purpose is to test the hypothesis that clonidine reduces frequent VT better than beta blocker in patients with ICDs. After informed consent patients will be randomized in a single blind fashion to either clonidine or metoprolol given three times per day. Other prescribed drugs may be adjusted to promote toleration of the study drug. ICD interrogations of episodes of VT will be the primary endpoint. Device based NIPS (non-invasive programmed stimulation) testing in a subset of these patients will allow mechanistic understanding of the clonidine effect. All of the procedural techniques are in place as performed clinically; preliminary data are given showing feasibility of the project.

we had wanted very commonly occurring VT episodes on ICD interrogation: 5 episodes/ 3 months. We could not enroll more than 2 patients most of which have interventions to prevent episodes. Thus we could not enroll patients and discontinued the study in the first year.

Eligibility Criteria:
Inclusion Criteria:

* Implantable defibrillator treated patients with 5 episodes of ventricular tachycardia per 3 month period

Exclusion Criteria:

* No more than one shock/3 months
* No contraindication to clonidine
* Non-compliance
* Asthma
Vaccine Observation to Include All Communities for Equitable Science

VOICES is a longitudinal, prospective, observational study that will enroll up to 10,000 subjects of diverse racial backgrounds being administered an emergency use authorized COVID-19 vaccine, for collection and analysis of stool and blood samples. It has recently been shown that the gut microbiome, the collection of microbes that line our GI tract, play a significant role in vaccine immune response and severe complications from COVID-19. The identification of biomarkers may aid in predicting response to vaccination and are critical towards improving vaccine-induced immunity. These real-world patient derived biomarkers could be used as interventional targets for the design of innovative adjuvant co-therapies that can boost an effective immune response to the vaccine, enhancing efficacy for a broader population, including those at most risk.

Subjects who meet the entry criteria will provide two samples each of blood, one prior to and one following vaccine administration. Follow-up questionnaires will be sent at 3, 6, 9, and 12 months to determine if participants have contracted COVID-19 or have experienced any adverse effects of the vaccine. Nasal swab samples will also be collected from participants that have contracted COVID-19. The samples will be analyzed to determine the impact of gut microbiome composition and function on the immune system and vaccine efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Men or women who are ≥ 18 years old and expecting to receive the SARS-CoV-2 vaccine within the next 30 days.
* Subjects who are able to provide written informed consent.

Exclusion Criteria:

* Subjects with known HIV, Hepatitis A, Hepatitis B, Hepatitis C, or SARS-CoV-2 infection within 4 weeks of vaccination
* Subjects without the mental capacity to complete either a written or online questionnaire, alone or with assistance, or make sound decisions
* Women who are pregnant, plan on becoming pregnant, or are nursing.
The Use of an Open Label Placebo to Treat Cancer Related Fatigue in Cancer Survivors

The purpose of this randomized-controlled, crossover pilot trial is to evaluate the feasibility, acceptability and effects of a non-deceptive (open-label) administration of placebo pills for treating cancer related fatigue (CRF). If significant effects are found, the investigators will later determine if the presence of a COMT Val18Met genotype variant predicts placebo responses.

The investigators will conduct a pilot randomized-controlled, crossover trial to evaluate the feasibility, acceptability and effect of the open-label administration of placebo pills on CRF and associated psychosocial factors (e.g., emotional health, social health, quality of life, etc.) for cancer survivors (CSs) who have completed all cancer treatments yet continue to experience CRF. Additionally, in an exploratory manner, the investigators will collect DNA saliva specimens that will be analyzed for potential biomarkers that may predict placebo responses. To do this, investigators will use a 7-week, single site, two-parallel arm, randomized controlled crossover pilot study to determine the feasibility, acceptability and effects of an Open Label Placebo Intervention (OLPI) on CSs who completed cancer treatments at least 6 months prior to enrollment in the study and report a fatigue score of 4 or greater on a 0-10 scale. Investigators will enroll 80 eligible CS participants who will be randomized into two groups of 40 (Group1 and Group2 ). In this crossover study, participants in Group1, will receive an OLP (placebo pill) for 21-days (Period 1)and Group2 (Observational Controls) will not. After a 1-week washout period, Group2 will receive the OLP for 21-days (Period 2) and Group1 (Observational Controls) will not.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Stage II - IV cancer;
* Completed primary treatment 6months to 10 years;
* Report ≥4 (moderate fatigue) on a 0-10 fatigue severity rating scale;
* Agree not to change any medications or treatments during the study;
* Willingness to make 4 clinical site visits over the course of the 49-day study.

Exclusion Criteria:

* Stage 1 cancer;
* Uncontrolled diabetes;
* Uncontrolled COPD;
* Uncontrolled ischemic heart disease;
* Uncontrolled liver/kidney diseases;
* Uncontrolled autoimmune diseases;
* Uncontrolled psychiatric or cognitive diseases.
Non-invasive Cardiac Output Monitor in Young Adults

The investigators would like to study cardiac output, stroke volume, and fluid responsiveness on young adult pediatric patients undergoing anesthesia and surgery with the use of the NICOM, a non-invasive monitor. The NICOM method is non-invasive and provides reliable trending of cardiac output and stroke volume. Measuring cardiac output in conjunction with routine monitoring will provide a better assessment of intra-operative status.

This study will involve measurements of cardiac output, stroke volume, and fluid responsiveness (change in stroke volume of ≥ 10%) obtained via passive leg raise (PLR) before and after anesthesia induction.

Eligibility Criteria:
Inclusion Criteria:

* 18 -30 years of age
* presenting for surgery at Riley or University Hospital

Exclusion Criteria:

* younger than 18
* severely mentally handicapped
* orthopedic cases with leg injuries
* any other contraindications that would prevent or discourage passive leg raises
* if deemed ineligible by an investigator for any other reason.