cyrilzakka/clinical-trials huggingface dataset:
Advancing Diabetes Management in Adolescents Using Health Information Technology

The study will compare three treatment strategies to look at the best clinical outcomes.

The investigator hypothesizes that the combined approach of a health information technology program plus a conflict-management contract will lead to the best outcomes.

This study will compare three strategies for enhancing adherence to diabetes care in our population. The study will look at which strategy results in the best short-term clinical outcomes for the population. Also, the study will look at patient satisfaction of contact with his/her health care team, quality of life, and family dynamics.

The three arms are:

1. HIT (health information technology) aided approach
2. Contracted conflict-management strategy
3. Combination of the HIT-aided approach and the contracted conflict management strategy

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes diagnosed for at least 6 months
* At least one or more parent/guardian who agrees to participate

Exclusion Criteria:

* Other chronic diseases with the exception of well-controlled asthma or treated thyroid disease
Overcoming Barriers and Obstacles to Adopting Diabetes Devices (ONBOARD) Trial

This study is a comprehensive, multicomponent behavioral intervention package (ONBOARD; OvercomiNg Barriers \& Obstacles to Adopting Diabetes Devices). ONBOARD will provide adults with T1D the skills to maximize benefit and minimize daily interference from barriers associated with Continuous Glucose Monitoring (CGM) and increase readiness for closed loop.

The investigators will enroll 178 adults with T1D between 18-50 years of age. Participants must not have been using CGM regularly for past 6 months. Once consented and enrolled, baseline demographic and psychosocial data will be obtained. Participants will receive 12 weeks of CGM supplies at no cost to them and provided with initial standard CGM introduction and education. Participants will then be randomized to receive ONBOARD or CGM-only. Those randomized to the ONBOARD condition will schedule 4 60-minute sessions with study interventionist (every 2 weeks). Hemoglobin A1c values, CGM usage data, and psychosocial data will be collected at baseline, 3-months (post-intervention), and 6- and 12-months post-baseline.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is age 18-50 years at time of enrollment
2. Subject must not have been using CGM regularly for past 6 months
3. Subject has a clinical diagnosis of type 1 diabetes
4. Subject comprehends spoken and written English

Exclusion Criteria:

1. Subject has a medical disorder that in the judgment of the investigator will interfere with completion of any aspect of the protocol.
2. Subject has a neurologic disorder that in the judgment of the investigator will affect completion of the protocol.
Topiramate Versus Placebo as add-on Treatment in Patients With Bipolar Disorder in the Outpatient Setting

The purpose of this study is to assess the efficacy and safety of adding topiramate as compared to placebo to the medications a patient with bipolar disorder is already taking (lithium or valproate) to see if adding topiramate will better control the patient's manic symptoms.

Many patients with bipolar disorder (manic-depressive illness) require more than one medication to control their symptoms. This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-groupd study to evalute the efficacy and safety of topiramate versus placebo as add-on therapy to lithium or valproate for the treatment of bipolar 1 disorder as an outpatient setting. These patients must already be taking either lithium or valproate for at least 6 weeks before the first visit and have been on the same dose of the mood stabilizer for at least 2 weeks before the first visit. Paitents will be randomized to receive either placebo or topiramate, an anti-seizure medication not approved for the treatment of bipolar disorder, in addition to their lithium or valporate. The study consists of 56-day titration (topiramate will be titrated up to 400mg per day or the maximum tolerated dose), 28-day continuation period, and 7 days of follow-up to taper off the medication. The study hypothesis is that topiramate will be more effective than placebo in the treatment of mania in type 1 bipolar disorder patients as measured by the Young Mania Rating Scale (YMRS) and will be well tolerated. YMRS is a questionnaire consisting of 11 items designed to assess severity of mania symptoms.

Patients will start taking topiramate 25 mg per day or placebo by mouth. Over the next 8 weeks, doses will be increased to up to 400 mg per day or to the maximum tolerated dose, whichever is lower. After the first 8 weeks, patients will stay at the established dose for the next 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Bipolar Disorder Type I
* Total Young Mania Rating Scale (YMRS) score of 18 or higher
* Currently being treated with a mood stabilizer (lithium or valproate)
* Having a stable therapeutic dose of the mood stabilizer in their bloodstream
* Currently not requiring hospitalization

Exclusion Criteria:

* Patients taking an antidepressant or anti-seizure medication
* Hospitalized paitents
* Women who are pregnant or breast-feeding
* Women who are not using birth control
* Patients with history of drug or alcohol abuse
Lumbar Puncture in Emergency Under Nitrous OXide

Lumbar puncture (LP) is a frequent exam that can cause pain and anxiety. In a scheduled setting, it has been shown that nitrous oxide use during the procedure was able to reduce both pain and anxiety. The goal of this trial is to confirm these results in a more heterogeneous group of patients having a LP, in an emergency setting.

Nitrous oxide (N2O) has analgesic and anxiolytic properties that are known for more than a century. Nonetheless, it's use during lumbar puncture in adults has only been investigated in a scheduled setting.Thus, this study is designed to evaluate the analgesic effect of N2O on the pain induced during lumbar puncture.

Patients with urgent lumbar puncture realized for diagnosis purposes will be randomized in 2 groups. One group will inhale N2O for the 5 minutes before the puncture and during the rest of the procedure. The second group will inhale compressed air during the same period. Neither the investigator realizing the lumbar puncture, nor the patient will know which type of gaz they are inhaling (double-blinding).

The maximal pain level that occurred during the procedure will be evaluated on a Numerical Rating Scale (NRS). NRS will also be used to evaluate the maximal anxiety induced by the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients coming in emergency service who need a lumbar puncture in emergency for a diagnostic purpose
* at least 18
* affiliated to the French state healthcare insurance system
* able to give consent to participation

Exclusion Criteria:

* Previous use of nitrous oxide (medical or recreational)
* Contra-indication to nitrous oxide use
* Face mask phobia
* Stage II obesity (BMI \> 35)
* Hemodynamic instability and/or any case when coagulation results cannot be waited
* Cognitive condition defined by a previous Mini Mental State Examination \< 24/30
* Confusion or any consciousness disorder that might interfere with judgment or consent
* Patient unable to communicate verbally
* Patient placed under a legal protection measure (tutorship, curatorship or a mandate)
* Any medical condition that might contra-indicate medical research, in physician's opinion
RHAPSody: Diagnostic Utility of RUSH Following ROSC

This will be a prospective observational study of adult primary cardiac arrest patients presenting to Shands Emergency Department following ROSC or actively in cardiac arrest with subsequent ROSC after treatment in the emergency department.

This will be a prospective observational study of adult primary cardiac arrest patients presenting to Shands Emergency Department following ROSC or actively in cardiac arrest with subsequent ROSC after treatment in the emergency department. The study will be a single center pilot study to evaluate the role of the extended RUSH exam in patients following cardiac arrest in order to potentially diagnose the cause of their arrest. No control group will be included in this study due to ethical concerns of withholding a potentially life-saving diagnostic test. Patients will be treated with ACLS per standard of care and resuscitation measures given. Within two hours of return of spontaneous circulation, the RUSH exam will be performed by ultrasound-trained emergency department physicians with images saved into the Qpath system, our already existing database where all emergency ultrasound exams - education and diagnostic - are stored currently. The physician who performed the exam will fill out a checklist with their interpretation and findings based on the elements included in the exam. The data collected will be stored in a RedCap database. Identifying data will be removed from the images and reviewed by two experienced ultrasonographers who will give separate interpretations, and inter-observer reliability will be examined. We will then correlate the interpretation with that of the physicians performing the exam. The elements of the RUSH exam that will be performed include focused evaluation of the heart, inferior vena cava, abdomen and aorta with the addition of evaluation for DVT and ocular ultrasound. The evaluation for DVT will be an abbreviated exam with one view of each of the bilateral femoral veins and popliteal veins. Techniques for performing the exam are based on the 2012 RUSH guidelines \[2\]. The data will undergo statistical analysis to determine if the data supported the initial hypotheses. Subjects will be contacted 30 days following the initial study for telephone follow-up and a CPC assessment for neurologic recovery will also be performed at that time.

Eligibility Criteria:
Inclusion Criteria:

* Incoming ER patients with return of spontaneous circulation after cardiac arrest

Exclusion Criteria:

* Patients who do not achieve return of spontaneous circulation long enough for the exam to be performed
* Patients who have initial cardiac arrest while on an inpatient unit of the hospital
Enhancing Immune Health Randomized Controlled Trial

This study tests a psychosocial intervention to improve immune health literacy and behaviors among adults with mental illnesses.

This study is testing the efficacy of a brief intervention designed to improve immune health literacy and behaviors among adults with mental illnesses. This psychoeducational intervention supports lifestyle changes, including promotion of immunity-enhancing nutrition and immunity aids, activated intentions to receive needed inoculations and annual health screenings, better sleep, and more effective stress management. Adult clients of collaborating community mental health agencies are randomly assigned to the intervention plus services as usual, versus services as usual alone. They are assessed at baseline, two months post-baseline, and three months later. Multivariable analysis models are used to assess the primary outcome of self-reported immune status.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older
* Serious mental illness
* Membership in a collaborating community mental health agency
* Access to the Internet
* Able to provide informed consent

Exclusion Criteria:

* Cognitive impairment preventing informed consent
* Unable to communicate in English
Advanced Practice Provider Intervention Study to Promote Wellness

This exploratory pilot study is designed as interventional study to examine the efficacy of a wellness initiative that involves use of a licensed clinical professional counselor (LCPC) to assist in the development of diverse coping strategies such as management of stressors, self-care, time management, and any other goals, problems or concerns that APPs would like assistance with during the intervention period.

The purpose of this study is to evaluate an educational professional wellness program designed to assist professional clinicians in developing self-awareness and self-care choices as a means to improve engagement and resilience and to avoid/reduce burnout.

Eligibility Criteria:
Inclusion Criteria:

* employment within non-profit health care setting as a health care professional
* working at least 50% of time in direct patient care
* availability and interest in initial and follow-up wellness visits

Exclusion Criteria:

* actively participating in formalized counseling sessions through other services at time of recruitment into the study
Ropivacaine-Poloxamer 407 Gel for Pain Control After Open Gastrectomy

The study evaluates the efficacy of Ropivacaine-Poloxamer 407 hydrogel in reducing postoperative pain following open gastrectomy.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with a histologically confirmed diagnosis of gastric adenocarcinoma prior to surgery.
2. Patients who have undergone a complete surgical resection (R0 resection).
3. Patients with an ASA (American Society of Anesthesiologists) score of 3 or below.
4. Patients aged 20 years or older.

Exclusion Criteria:

1. Patients under 19 years of age.
2. Presence of ascites or peritoneal metastasis.
3. Patients who have undergone preoperative chemotherapy or radiotherapy.
4. Diagnosis of malignancies other than gastric cancer.
5. Uncontrolled diabetes, autoimmune diseases, hypertrophic scars, or keloid history affecting wound healing.
6. History of allergy or adverse reactions to Ropivacaine or other local anesthetics.
7. Pregnant women.
8. Patients with preoperative chronic pain conditions, including CRPS.
9. Patients with long-term preoperative use of opioid analgesics.
10. Patients with psychiatric disorders deemed likely to interfere with study participation.
11. Patients with severe liver disease, renal disease, or arrhythmia.
Extended Pancreatic Transection Versus Conventional Pancreatic Transection During Laparoscopic Pancreaticoduodenectomy

The level of pancreatic neck transection during laparoscopic pancreaticoduodenectomy (LPD) is not conclusive. Theoretically, the level of pancreatic transection can significantly affect the occurrence of postoperative pancreatic fistula (POPF) by influencing both the blood supply to the anastomosis and the location of the main pancreatic duct in the pancreatic transverse section. The investigators conduct a retropective propensity score-matched comparison to compare the impact of extended pancreatic transection and conventional pancreatic transection on POPF and the performance of the pancreaticojejunostomy during LPD.


Eligibility Criteria:
Inclusion Criteria:

1. consecutive patients underwent elective laparoscopic pancreaticoduodenectomy within October 2019 to April 2023
2. the perioperative and follow-up study data information can be collected completely
3. The level of pancreatic neck dissection can be determined by postoperative abdominal CT
4. patients without the history of neoadjuvant chemotherapy or radiotherapy

Exclusion Criteria:

1. conversion to laparotomy due to various reasons during operation;
2. combined with resection and reconstruction of the portal vein or the superior mesenteric vein
3. combined with other organ resection
4. the perioperative and follow-up study data information can not be collected completely, or the level of pancreatic neck dissection can not be determined by postoperative abdominal CT
5. patients with the history of neoadjuvant chemotherapy or radiotherapy
6. the main pancreatic duct did not be found during the operation, the duct-to-mucosa pancreaticojejunostomy could not be performed
Longitudinal Sexual and Reproductive Health Study of Women with Breast Cancer and Lymphoma

The purpose of this study is to see how cancer treatment affects sexual and reproductive function. The patient will also be asked to participate in blood draws to see if and how cancer treatment affects the ovaries and the ability to have children (fertility). These blood draws are optional and the patient can still participate in the questionnaire portion of the study even if they choose not to have their blood drawn.


Eligibility Criteria:
Inclusion Criteria:

Subject Inclusion Criteria for Cohort of Premenopausal Women with Early Stage Breast Cancer and Lymphoma

* Women, 18 years of age and older
* Premenopausal women at time of diagnosis who have either been pregnant or had at least one menstrual period in the last 12 months

  * Note: premenopausal women at time of diagnosis who have not been pregnant or have not had at least one menstrual period in the last 12 months are able to participate only if they have had an intrauterine device (IUD) in place within the last 12 months.
* Women with newly diagnosed breast cancer (stage 0-III) who are within 1 month of starting systemic treatment or women with any aggressive lymphoma being treated with first line therapy with curative intent.
* Breast cancer patients with any receptor type
* English speaking
* Able to participate in the informed consent process

Subject Inclusion Criteria for Tamoxifen Only Subset of Cohort of Premenopausal Women with Early Stage Breast Cancer and Lymphoma

* Women, 18 years of age and older.
* Premenopausal women at time of diagnosis who have either been pregnant or had at least one menstrual period in the last 12 months

  * Note: premenopausal women at time of diagnosis who have not been pregnant or have not had at least one menstrual period in the last 12 months are able to participate only if they have had an intrauterine device (IUD) in place within the last 12 months.
* Women with newly diagnosed breast cancer (stage 0-III) who have not yet started treatment and are planning to start Tamoxifen as their only form of systemic treatment within one month
* Breast cancer patients with any receptor type
* English speaking
* Able to participate in the informed consent process

Subject Inclusion Criteria for Cohort of Postmenopausal Women with Early Stage Breast Cancer and Lymphoma

* Women, 18 years of age and older.
* Postmenopausal women at time of diagnosis who have been without period for ≥ 2 years.
* Women with newly diagnosed breast cancer (stage 0-III) who are within 1 month of starting systemic treatment or women with any aggressive lymphoma being treated with first line therapy with curative intent.
* Breast cancer patients with any receptor type
* English speaking
* Able to participate in the informed consent process

Exclusion Criteria:

Subject Exclusion Criteria for both Pre and Postmenopausal Women with Early Stage Breast Cancer and Lymphoma

* Active secondary cancer requiring cytotoxic chemotherapy
* Prior systemic treatment for a malignancy
In-Vivo Activated T-Cell Depletion to Prevent GVHD

The purpose of this study is to compare the effects (good and bad) of the medication basiliximab in combination with cyclosporine with cyclosporine alone for the prevention of graft-versus-host disease.

This research is being done because there is no completely safe and effective prevention for graft-versus-host disease. It is known that cyclosporine helps with GVHD but we would like to know if the addition of basiliximab will decrease the incidence and/or severity of GVHD after a transplant known as nonmyeloablative ("mini" transplant).


Eligibility Criteria:
Inclusion Criteria:

* Acute myelogenous leukemia, Acute lymphocytic leukemia, Chronic myelogenous leukemia, Chronic lymphocytic leukemia, Myelodysplasia, Non-Hodgkin's Lymphoma, Mantle cell, Hodgkin's Disease, Multiple Myeloma, Myelofibrosis with disease-specific eligibility requirements as outlined in the protocol
* Donor Requirement: Must have a fully HLA-matched (10 of 10) related or unrelated donor, eighteen years of age or older, who is capable of undergoing GCSF mobilization and apheresis.

Exclusion Criteria:

* Active CNS disease (the presence of leukemic blasts in the CSF)
* Pregnancy or breast-feeding
* SGOT \>3x upper limit of normal
* Creatinine \>2 or creatinine clearance \<50cc/hr.
* Fractional shortening by echocardiogram not within normal limits per institution
* Pulmonary function: DLCO less that 50% of normal predicted, corrected for anemia
* Prior allogeneic transplant
A Pilot Study of Berberine (Soloways ™) in Patients with Type 2 Diabetes Mellitus Carrying TCF7L2 Polymorphisms

This pilot, genotype-stratified clinical trial aims to investigate the safety and preliminary efficacy of berberine supplementation in adult patients with type 2 diabetes mellitus (T2DM) who carry a specific high-risk TCF7L2 polymorphism (e.g., rs7903146) in the homozygous state. The study will compare improvements in glycemic control and metabolic markers between two groups: (1) homozygous carriers of the TCF7L2 "unfavorable" variant and (2) non-carriers (wild-type). It is hypothesized that berberine will yield greater reductions in HbA1c and fasting plasma glucose among homozygous carriers, potentially due to their distinct TCF7L2-mediated insulin secretion and sensitivity pathways.

Type 2 diabetes mellitus is driven by a combination of insulin resistance and impaired insulin secretion. Genetic polymorphisms in the transcription factor 7-like 2 (TCF7L2) gene have been strongly associated with an increased risk of T2DM, potentially through altered beta-cell function and incretin signaling. Berberine, a natural alkaloid derived from plants such as Coptis chinensis, has demonstrated hypoglycemic effects by modulating pathways like AMPK, thereby improving insulin sensitivity and glucose metabolism. This pilot trial aims to clarify whether berberine offers a more pronounced metabolic benefit to individuals homozygous for a "high-risk" TCF7L2 polymorphism by targeting their unique pathophysiological mechanisms. Results will inform future larger-scale, genotype-focused interventional trials.

Eligibility Criteria:
Inclusion Criteria:

* Adults (age 30-70 years) with a confirmed diagnosis of type 2 diabetes mellitus.
* On stable doses of metformin or other standard oral antihyperglycemic agents for at least 4 weeks prior to enrollment.
* Willingness to undergo genetic testing for TCF7L2 polymorphisms. For the Homozygous Variant Cohort: confirmed homozygous high-risk TCF7L2 polymorphism (e.g., rs7903146) prior to enrollment.
* For the Non-Variant Cohort: confirmed wild-type TCF7L2 genotype.

Exclusion Criteria:

* Current use of insulin therapy or recent (within 4 weeks) change in diabetic medications.

Known hypersensitivity or intolerance to berberine or related compounds.

* Significant renal or hepatic impairment.
* Pregnancy or breastfeeding.
* Any other acute or chronic condition that, in the investigator's judgment, could compromise the patient's safety or the study's integrity.