cyrilzakka/clinical-trials huggingface dataset:
Irinotecan, Carboplatin and Radiation Therapy Followed by Bevacizumab in Limited Stage Small Cell Lung Cancer

In this multicenter trial, we plan to evaluate the feasibility and toxicity of initial treatment with irinotecan/carboplatin/radiation therapy, followed by treatment with bevacizumab, in patients with limited stage small cell lung cancer.

Upon determination of eligibility, all patients will be receive:

* Irinotecan + Carboplatin + Radiation Therapy + Bevacizumab

Patients will receive 4 courses of irinotecan/carboplatin. Radiation therapy will begin concurrently with the third course of chemotherapy. The intervals between chemotherapy courses will be 21 days except for the interval between the third and fourth courses (during radiation therapy), which will be 28 days.

Eligibility Criteria:
Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Small cell lung cancer, confirmed by biopsy.
* Limited stage disease after standard evaluation.
* Able to perform activities of daily living without assistance.
* No previous treatment with chemotherapy, radiation therapy, or biologics.
* Measurable or evaluable disease
* Adequate bone marrow, liver and kidney function
* Able to understand the nature of this study and give written consent.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Age \< 18 years
* History of previous malignancies
* Women pregnant or lactating
* History or physical exam evidence of central nervous system disease)
* Active infection requiring intravenous antibiotics
* Full-dose anticoagulation or thrombolytic therapy within 10 days
* Proteinuria.
* Serious nonhealing wound, ulcer, or bone fracture
* Evidence if bleeding diathesis or coagulopathy
* History of heart attack within 6 months.
* Uncontrolled cardiovascular disease
* PEG or G-tube
* History of other serious disease

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Monitoring Patients With Severe Obesity Treated With Wegovy® Using Connected Device: Real-world Data

This study involves collecting real-world data on body weight, body composition, cardiovascular parameters, and neurovegetative parameters using a connected scale in patients with severe obesity treated with Wegovy®.

Obesity is a chronic disease associated with numerous co-morbidities. New treatments for obesity, notably GLP-1 (Glucagon-like peptide 1) analogs, have led to promising advances. Semaglutide 2.4 mg weekly subcutaneous injection, marketed under the brand name Wegovy®, was recently approved in France for weight loss in patients with severe obesity and at least one comorbidity. Several real-world studies have confirmed the effectiveness of semaglutide in reducing body weight and HbA1c. However, few studies have evaluated the kinetics and interindividual variability of changes in body weight and composition as well as cardiovascular health. There appears to be a need for a comprehensive real-world assessment of patients living with severe obesity receiving Wegovy®.

The TELE-SEMA project involves collecting real-world data on body weight, body composition, cardiovascular and neurovegetative parameters via connected scales in patients with severe obesity treated with Wegovy®.

The main objectives will be to assess inter-individual weight variability and explore the determinants that may influence weight loss, body composition and possible eating disorders.

Eligibility Criteria:
Inclusion Criteria:

* Man or woman aged over 18 years
* Patients who have reached the maximum dose of their treatment with Wegovy®
* Written consent

Exclusion Criteria:

* Patient on AME (state medical aid)
* Pregnant or breastfeeding woman
* Patient who does not speak French
* Adults under legal protection
Safety, Pharmacokinetics and Pharmacodynamics of DSP-8658 in Patients With Type 2 Diabetes Mellitus and Healthy Adults

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of DSP-8658 in patients with Type 2 diabetes mellitus and healthy adults.


Eligibility Criteria:
Inclusion Criteria: Diabetic subjects

* Age ≥ 18 and ≤ 65 years
* Body Mass Index ≤45
* Drug naive type 2 diabetes or type 2 diabetes previously treated with an oral antidiabetic drug

Inclusion Criteria: Healthy subjects

* Age ≥ 18 and ≤ 65 years
* Body Mass Index ≥ 18 and ≤ 29
* Good health as determined by medical history, ECG, clinical chemistry, hematology, urinalysis, virology, and a physical examination.

Exclusion Criteria: Diabetic subjects

* Have a current or expected requirement for any antidiabetic or lipid-lowering drug

Exclusion Criteria: Healthy subjects

* Have, or have had a history of clinically significant neurological, urological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, or other major disorders including cancer
The Association of Neurotoxin Exposure With Parkinson's Disease and Parkinsonism in World War II Veterans and Other Men

This program aims to investigate factors associated with development of parkinsonism or idiopathic Parkinson's Disease in an ongoing cohort of patients established in 1965 who are currently undergoing their sixth examination.


Eligibility Criteria:
This is a cohort study. Population consist of 8,006 Japanese-American men.
Prediction of Cervical Lymph Node Metastasis in Papillary Thyroid Carcinoma Based on Ultrasound and Cytological Images

Rising thyroid carcinoma rates, with papillary thyroid carcinoma (PTC) as the main type (85-90% of cases), often show early cervical lymph node spread. This increases the risk of PTC patients for recurrence and death. A new study's multimodal model fuses preoperative US and cytology images to better predict lymph node metastasis, aiming to improve treatment plans, reduce unnecessary surgeries, and enhance patient outcomes.

Thyroid carcinoma incidence has been on the rise in recent years. Papillary thyroid carcinoma is the most prevalent type of differentiated thyroid carcinoma, accounting for 85% to 90% of malignant thyroid tumors. Despite its indolent nature, cervical lymph node metastasis is frequently observed at an early stage. Papillary thyroid carcinoma patients with cervical lymph node metastasis face an elevated risk of recurrence, distant metastasis, and mortality. Thus, non-invasive preoperative prediction of cervical lymph node metastasis is particularly vital for guiding treatment plans and prognostic. this study has developed a multimodal model integrating preoperative US images with cytological images of papillary thyroid carcinoma patients. The aim is to enhance the predictive accuracy for cervical lymph node metastasis, reduce unnecessary lymph node dissections, and provide real-time, precise guidance for determining the extent of surgical resection and prognostic assessment. This approach aims to optimize patient treatment strategies and enhance therapeutic outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Underwent thyroidectomy and bilateral lymph node dissection with pathological confirmation of PTC
* Completed US examination within one week before surgery
* Underwent preoperative us-guided FNAC
* Completed cytological images at 400× magnification under a microscope

Exclusion Criteria:

* Patients who underwent only unilateral thyroidectomy
* Patients with cervical lymph nodes shown on preoperative ultrasound
Breast Cancer AI Imaging Study

This study aims to develop a social health platform called MammoChat (https://MammoChat.com) that allows patients to share their real-world patient data to a trusted network for development of clinical intelligence to improve patient outcomes. Therefore:

1. The investigator will establish a Discourse social network where patients can anonymously and securely share their breast imaging and interact with other patients.
2. The investigator will use standardized questionnaires to understand the impact of use of the social network on outcomes related to breast cancer screening such as anxiety.
3. The investigator will assemble a crowdsourced, de-identified radiographic repository for training, testing, and validating AI models aimed at earlier and more accurate disease detection for breast cancer.

With over 40,000,000 mammograms run annually in the US, there are psychological consequences of breast cancer imaging that are well documented among patients such as stress and anxiety from largely false positive or indeterminant readings by radiologists.

This UCF MammoChat platform is one of the first projects that engages patients to donate their breast cancer imaging in an effort to reduce the psychological consequences of breast cancer imaging using social networks and artificial intelligence.

This repository will be supported and maintained by the University of Central Florida College of Medicine (UCF COM) Clinical and Aerospace Research team. These clinical research coordinators will operate the repository, including administering patients, imaging sites and transfers through an administrative panel.

Eligibility Criteria:
Inclusion Criteria:

* Adults, ages 18 and older
* Had a radiographic breast cancer imaging test, either for screening or diagnosis of breast cancer, with either positive or negative results performed in a US institution.
* Have an email account with access to a reliable internet connection or smartphone

Exclusion Criteria:

* Minors , ages under 18
* Prisoners. Given the repository design, prisoners are unlikely to participate and provide a consent
* Adults who are unable to provide consent.
Glutamine in Treating Neuropathy Caused by Vincristine in Young Patients With Lymphoma, Leukemia, or Solid Tumors

RATIONALE: Glutamine may help lessen neuropathy caused by chemotherapy. It is not yet known whether glutamine is more effective than a placebo in treating neuropathy caused by vincristine.

PURPOSE: This randomized phase II trial is studying glutamine to see how well it works compared to a placebo in treating neuropathy caused by vincristine in young patients with lymphoma, leukemia, or solid tumors.

OBJECTIVES:

Primary

* Determine the incidence of vincristine-induced peripheral neuropathy in pediatric patients with lymphoma, leukemia, or solid tumors.

Secondary

* Compare the safety of glutamine vs placebo in these patients.
* Compare the efficacy of glutamine vs placebo in reducing the progression and/or resolution of vincristine-induced peripheral neuropathy in these patients.
* Compare the effect of glutamine supplementation vs placebo on chemotherapy-related toxicities in these patients.
* Compare the effect of glutamine vs placebo on measures of quality of life in these patients.
* Compare the effect of glutamine supplementation vs placebo on serum nerve growth factor and glutamine levels in these patients.
* Determine the effect of glutamine on vincristine-mediated antitumor efficacy in vitro.

OUTLINE: This is a randomized, double-blind, placebo-controlled, pilot study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21.
* Arm II: Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21.

Patients in both arms undergo neuropsychological and clinical neurological assessment, blood collection for serum marker (e.g., serum glutamine and nerve growth factor) analysis, and quality of life assessment on days 1, 21, and 42.

After completion of study treatment, patients are followed for an additional 21 days.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Eligibility Criteria:
Inclusion Criteria:

* Patients between the age of 5 and 21 years old.
* Patients who demonstrate the ability to complete the assessment instruments at baseline.
* Patients who are diagnosed with leukemia or solid tumors and are expected to receive a cumulative dose of \> or = to 6mg/m2 of vincristine, or \> 6mg if individual vincristine doses are capped at 2mg according to primary cancer treatment protocol, over a 30-week period.

Exclusion Criteria:

* Patients with primary CNS tumors other than medulloblastoma or patients with CNS metastasis.
* Patients with recurrent disease.
* Patients with Grade II, III or IV neurological status by the NCI CTC (Ver. 3.0) on clinical exam.
* Patients who have already received \> 8mg/m2 of vincristine, or \> 8mg if individual vincristine doses are capped at 2mg according to primary cancer treatment protocol, during their course of therapy at time of consent.
* Patients with hepatic encephalopathy or hyperammonemia.
* Patients with a focally abnormal neurologic exam.
Beneficial Effects of Dietary and Lifestyle Change in Overweight and Obese Subjects

Obesity and overweight are noncommunicable diseases with increasing incidence in children, adolescents and adults. In 2016, more than 1.9 billion adults aged 18 and over were overweight and over 650 million were obese (WHO). In the EU-27 (Eurostat data), 45.7% of women and 60.2% of men were overweight, while 16.3% and 16.8%, respectively, were obese. The growing incidence of overweight and obesity generate worldwide increasing incidence of related conditions as cardiovascular diseases, diabetes, metabolic disorders, and cancer, with relevant socio-economical (increase in health costs, increase in disabilities) and environmental consequences (unsustainability of food models, increase in ecological footprint, worsening of climate changes). A transformation of food systems and individual behaviours are necessary to improve the quality of life and the sustainability of lifestyle, which should be oriented at preventing o treating overweight and obesity.

The study is aimed to measure the beneficial effects of specific dietary models (i.e., Mediterranean Diet) and healthy lifestyle (i.e., controlled physical activity) in reducing body/organ fat accumulation and in the improvement of metabolic health. A comprehensive and combined analysis of these effects (mainly following personalized strategies and close follow-up) on pathogenic mechanisms affecting cardiovascular and metabolic risk, pro-inflammatory status and intestinal permeability in the medium-long term is still lacking.

During the study, overweight/obese subjects (i.e. Body Mass Index equal or higher to 25Kg/m2) will be assessed at basal and monitored during a 24 months follow-up

Eligibility Criteria:
Inclusion Criteria:

* overweight or obese patients
* patients who able to sign informed consent

Exclusion Criteria:

* failure to sign informed consent;
* inclusion in other research protocols
* Normal weight patients
Randomized Controlled Trial of Rectal Indomethacin Versus Combined Pancreatic Stent Placement and Rectal Indomethacin for Preventing Post-ERCP Pancreatitis

The goal of this clinical trial is to compare rectal indomethacin alone versus combined pancreatic duct stenting and rectal indomethacin in prevention of post ERCP pancreatitis. The main question it aims to answer is: whether rectal indomethacin alone is superior to combination of pancreatic duct stenting and rectal indomethacin in prevention of post ERCP pancreatitis Participants will be patients who give consent to the study and who are required to undergo ERCP as part of their standard care.

If there is a comparison group: Researchers will compare \[rectal indomethacin alone versus combined pancreatic duct stenting and rectal indomethacin in prevention of post ERCP pancreatitis.\] to see if \[whether rectal indomethacin alone is superior to combination of pancreatic duct stenting and rectal indomethacin in prevention of post ERCP pancreatitis\].


Eligibility Criteria:
Inclusion Criteria:

1. Suspected sphincter of Oddi dysfunction
2. History of post ERCP Pancreatitis
3. Pancreatic instrumentation or sphincterotomy.
4. Precut sphincteroyomy
5. Difficult cannulation defined by more than 5 cannulation attempts
6. The use of double wire technique in bile duct access
7. At least 2 of the followings including

   1. Female age \< 50 year
   2. 3 pancreatogram
   3. Acinarization (Contrast injection to tail of pancreas
   4. Normal serum bilirubin
   5. Guidewire to the tail of pancreas or secondary branches

Exclusion Criteria:

1. Patient planned for pancreatic stenting
2. Without informed consent
3. Age \< 18 years
4. Pregnant women
5. Lactating women
6. Patient with altered anatomy
7. Contraindications to the use of NSAIDS
8. Renal failure
9. Ongoing or recent hospitalisation for acute pancreatitis
10. Allergy to aspirin or NSAIDs
11. known chronic calcific pancreatitis -
A Study of Hemodynamic Changes Using Near Infra-red Spectrometry (NIRS) in Infantile Epilepsy Spasms

This study will included 20 children presenting with epilepsy with spasms. It aims to offer these children, non invasively and without supplementary examinations, a recording of local and cerebral hemodynamic changes concomitant with an electroencephalographic recording during epileptic episodes. This will be carried out by combining optical imaging using near infra-red spectroscopy (NIRS) with electroencephalography (EEG), in a simultaneous high-resolution (HR) recording.

This study is among those based on multimodal analyses of epilepsy, combining methods of analysis of electrical activity (electrical imaging) and hemodynamics (optical imaging).

Surface electroencephalography (EEG) is a precious tool enabling the study of neuronal dysfunction from a functional point view. It is used in the routine follow-up of children with epilepsy. Optical imaging is a promising medical imaging technique. It uses light in the spectral regions of near infra-red as a source of radiation. It is quantitative, rapid, non invasive, and inoffensive which could easily be used at the child's bedside or in a clinical setting and can provide metabolic information about cerebral function.

This study is multidisciplinary, which calls upon the skills of neurophysiologists, biophysicists, and clinicians


Eligibility Criteria:
Inclusion Criteria:

* Children between 3 and 6 years old presenting infantile spasms according to the Classification of the International League Against Epilepsy

Exclusion Criteria:

* Children younger than 3 months and older than 6 years of age, refusal of one of the parents, and dermatosis of the scalp
A Formulation Screening Study of Dalcetrapib and Atorvastatin in Healthy Volunteers

A single-center, crossover study to evaluate the pharmacokinetics of dalcetrapib and atorvastatin from prototype fixed dose combination formulations in healthy volunteers. Volunteers will receive a single dose of dalcetrapib with atorvastatin in each of four treatment periods.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers, 18 to 55 years of age, inclusive

Exclusion Criteria:

* Any concomitant disease or ongoing condition that in the investigator's opinion could interfere with the study or could pose an unacceptable risk to the patient
* Clinically significant abnormal laboratory values
Surgical Stabilizer Assisted RVC With rtPA for CRVO

This phase Ib study investigates the safety and efficacy of performing a retinal vein cannulation with recombinant tissue Plasminogen Activator infusion into a retinal vein with the help of an updated dedicated surgical stabiliser for the treatment of central retinal vein occlusion.

Investigator-initiated, unmasked, single-arm, mono-center, prospective, interventional case series phase Ib trial. In line with the previous phase I trial, this trial will be biphasic; first 3 patients will be included, when the procedure and product prove to be safe and an added value is noted from the intra-operative OCT-angiography, another 3 will be included afterwards (≥21 days between last inclusion of the first group and first inclusion of the second group).

Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18 years
* Recent diagnosis (\<8 weeks) of CRVO
* Recent onset of symptoms (\<12 weeks)
* Visual acuity \< 5/10 in study eye
* Visual acuity \>1/10 in fellow eye
* Central macular thickness \>250µm
* Signed informed consent prior to inclusion

Exclusion Criteria:

* Fluorescein allergy
* Active neovascularization
* Eye disease other than CRVO or Cataract decreasing central vision
* History of retinal surgery
* High myopia (\> -10D)
* Contraindication for the use of systemic anticoagulant medication
* Extensive macular ischemia noted on fluo-angiography
Ridge Augmentation Without Primary Closure

This study is designed to compare the clinical and histologic results of ridge augmentation with and without primary closure over the barrier membrane. The hypothesis is that there will be no difference in crestal ridge width between the two groups.

A maximum of 30 patients will be selected that meet the following criteria:

Inclusion Criteria

1. At least a one tooth area with a ridge defect, treatment planned to receive a dental implant. The site must be bordered by at least one tooth.
2. Healthy person that is at least 18 years old.
3. Patient understands and signs an informed consent approved by the University of Louisville Human Studies Committee.

Exclusion Criteria

1. Patients with debilitating systemic diseases, diseases that affect the periodontium, or psychological problems that would interfere with treatment.
2. Previous head and neck radiation or chemotherapy within the previous 12 months.
3. Patients with known allergy to any of the materials that will be used in the study.
4. Smokers.
5. Patients who need prophylactic antibiotics prior to dental procedures.
6. Patients on long-term steroid therapy or oral bisphosphonates \> 3 years or any IV biosphosphonates.
7. Patients who are pregnant.

Eligibility Criteria:
Inclusion Criteria:

1. At least a one tooth area with a ridge defect, treatment planned to receive a dental implant. The site must be bordered by at least one tooth.
2. Healthy person that is at least 18 years old.
3. Patient understands and signs an informed consent approved by the University of Louisville Human Studies Committee.

Exclusion Criteria:

1. Patients with debilitating systemic diseases, diseases that affect the periodontium, or psychological problems that would interfere with treatment.
2. Previous head and neck radiation or chemotherapy within the previous 12 months.
3. Patients with known allergy to any of the materials that will be used in the study.
4. Smokers.
5. Patients who need prophylactic antibiotics prior to dental procedures.
6. Patients on long-term steroid therapy or oral bisphosphonates \> 3 years or any IV biosphosphonates.
7. Patients who are pregnant.