cyrilzakka/clinical-trials huggingface dataset:
Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging

The goal of this study is to use a clinical micro-ultrasound to systematically image the prostate before biopsy or surgery. The images from the ultrasound system will be saved and compared to other imaging modalities and pathology in order to develop better tools.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for MR-US fusion prostate biopsy or radical prostatectomy
* Agree to consent to the study

Exclusion Criteria:

* Does not agree to consent.
A Clinical Trial of Adaptive Treatment for Early Smoking Cessation Relapse

This is a research study to find out if treatment decision making can be improved for smokers who find it difficult to quit with medications. Everyone who participates in this study will receive free product, either nicotine replacement therapies (patches and lozenges), varenicline, or a harm reduction product (e-cigarette) for a full 12 weeks. Most participants will receive some combination of these treatments, depending on individual response to each.

All visits and study assessments will be entirely remote. All treatments will be provided free of charge for the first 12 weeks. After that, the study team will contact the participants 6 months after the first study phone call to complete another survey. The study lasts six months and will involve 8 surveys.

Treatment seeking smokers across both Alabama and South Carolina (N=544) will be recruited and consented through established online methods and randomized to receive a 4-week course of either varenicline or combination NRT (patch + lozenge), counterbalanced. Using a concrete and measurable indicator of early treatment success (3 days non-smoking), smokers demonstrating early success at 4 week follow-up will continue with another four weeks of same medication, either varenicline or combination NRT. Those who do not demonstrate early success will be randomized to a subsequent 4-week course of either a) continuation of same medication, or b) switch to the other FDA approved option, either varenicline or combination NRT. The same process will repeat at Week 8, wherein treatment responders will continue with their ongoing medication and non-responders will be randomized to a final 4-week course of either a) continuation of same medication or b) switch to an e-cigarette. End of treatment outcomes will be assessed at Week 12 at which time no more product will be offered. Final follow-up at Week 24 will ascertain all primary (cessation) and secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Smokers who want to quit

Exclusion Criteria:

* Non-smokers
Safety, Efficacy, and Tolerability of BOS172738 in Patients With Advanced Rearranged During Transfection (RET) Gene-Altered Tumors

This study will be conducted to assess the safety and tolerability of BOS172738 when administered to patients with advanced solid tumors with rearranged during transfection (RET) gene alterations and also to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of BOS172738.


Eligibility Criteria:
Inclusion Criteria:

Participants are eligible to be included in the study only if all of the following criteria apply:

* Male or female participants must be ≥ 18 years, at the time of signing the informed consent
* Diagnosis of advanced solid tumor with a documented rearranged during transfection (RET) gene altered malignancy as determined locally by a DNA based assay of tumor tissue and/or blood
* Participants must have no alternative approved therapy.
* For participants in Part B expansion cohort only: documented local diagnosis of either 1) advanced RET gene fusion non-small cell lung cancer (NSCLC); 2) advanced RET gene mutant medullary thyroid cancer (MTC); or 3) other RET gene altered advanced tumors or NSCLC/MTC with prior specific RET gene targeted therapy
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Negative pregnancy test for females of child bearing potential; must be surgically sterile, postmenopausal, or willing and able to be compliant with a contraceptive regimen
* Contraceptive use by men or women should be consistent with local regulations.
* Capable of giving signed informed consent

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

* Inability to take oral medications or gastrointestinal (GI) conditions that can interfere with the swallowing or absorption of study medication
* Uncontrolled or severe concurrent medical condition
* History of upper GI bleeding, ulceration, or perforation within 12 months prior to the first dose of study drug
* Known history of stroke or cerebrovascular accident within 6 months prior to the first dose of study drug
* Participants with known infection with human immunodeficiency virus (HIV) or Acquired Immune Deficiency Syndrome (AIDS) (testing not required)
* Participants who are hepatitis B surface antigen positive or participants who are hepatitis C antibody positive (Participants who have been successfully treated for hepatitis C virus \[HCV\] are eligible if an undetectable HCV viral load at least 6 months after completion of treatment can be demonstrated.)
* Any evidence of serious active infections
* Uncontrolled or severe cardiovascular disease
* Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements
* Participants with a prior or concurrent malignancy other than the malignancies under study
* Ongoing cancer directed therapy
Efficacy of Ear Neurostimulation for Adolescents With Functional Abdominal Pain

This study evaluates the effectiveness of a neurostimulator applied to the outer ear for adolescents with functional gastrointestinal disorders. The neurostimulator provides nerve stimulation to a branch of the vagus nerve which is thought to be involved in transmission of pain signals. Half of the study subjects will receive an active nerve stimulator while the other half will receive an inactive one.

The vagus nerve innervates the gastrointestinal tract and influences the autonomic nervous system. It is thought to carry signals of discomfort and nausea to the brain where it is interpreted. The autonomic nervous system may be in imbalance in patients with functional gastrointestinal disorders. By stimulating a branch of the vagus nerve in the outer ear, this study aims to improve symptoms and quality of life in adolescents with functional abdominal pain with or without nausea.

Subjects will be randomized into two groups: 1) neurostimulation versus 2) sham. They will receive either an active or non-active (sham group) device for 5 days each week x 4 weeks total. Pain, nausea, anxiety, quality of life, potential side effects and overall symptom improvement will be monitored weekly for the entire study as well as after the study is completed.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents with a major complaint of abdominal pain (minimum 3/10 in severity) with or without nausea (minimum 3/10 in severity) of unclear etiology, who are English-speaking and willing to participate and consent to the study and who have a parent willing to participate.
* Patients with symptoms of minimum three times per week for a duration of two months or greater
* Intact external ear that is free of infection or severe dermatological conditions.
* Stable vital signs for their respective age

Exclusion Criteria:

* Medically complex children or those who take a medication or suffer from an organic disease that can explain symptoms will be excluded from participation.
* Children or parents, who have developmental delay, will be excluded due to difficulties in accurately completing the questionnaires and assessing symptoms.
* History of seizures
* Currently implanted electrical device
* Orthostatic hypotension
Imaging Techniques for Identifying Factors of Sudden Cardiac Death Risk

Sudden cardiac death is a tragic event that strikes all age groups and is unfortunately increasing in prevalence. Because it is difficult to predict those at highest risk, this study is designed to test the hypothesis that new imaging techniques (magnetic resonance imaging \[MRI\] and computed tomography \[CT\]) are useful for identifying factors which put people at high risk for sudden death.

Some people with heart disease and a weak heart muscle experience abnormal electrical activity of the heart that may predispose them to sudden death. In light of this risk, it has been recommended that such patients undergo implantation of an implantable cardioverter defibrillator (ICD). Your doctors have determined that you are such a patient and are to undergo implantation of an ICD. It is unclear who among the many patients who undergo ICD implantation for this reason are at greatest risk of sudden death and therefore require electrical response from their ICD. This research is being done to determine whether new imaging tests, such as magnetic resonance imaging (MRI) or multi-detector computed tomography (MDCT), can be used to predict who is at highest risk of sudden death and require electrical response from their ICD.

Eligibility Criteria:
Inclusion Criteria:

* Left ventricular ejection fraction \<or = 35%
* Planned implantable cardioverter-defibrillator (ICD) implantation for clinical indications (primary prevention)

Exclusion Criteria:

* History of sudden death (secondary prevention)
* Contraindication to undergoing MRI (metallic implant, pacemaker, etc.)
Ultrasound-guided Fascia Iliaca Compartment Block Versus Periarticular Infiltration

This randomized, controlled, observer-blinded study clinical trial was designed to evaluate ultrasound-guided fascia iliaca compartment block with ropivacaine and periarticular infiltration with ropivacaine for postoperative pain management after total hip arthroplasty.

Despite substantial advances in our understanding of the pathophysiology of pain and availability of newer analgesic techniques, postoperative pain is not always effectively treated. Optimal pain management technique balances pain relief with concerns about safety and adverse effects associated with analgesic techniques. Currently, postoperative pain is commonly treated with systemic opioids, which are associated with numerous adverse effects including nausea and vomiting, dizziness, drowsiness, pruritus, urinary retention, and respiratory depression. Use of regional and local anesthesia has been shown to reduce opioid requirements and opioid-related side effects.

Patients undergoing total hip arthroplasty (THA) (n=60) at Parkland and UT Southwestern Medical Center Hospitals will be randomized into one of two groups to receive either ultrasound-guided fascia iliaca compartment block (FICB) with ropivacaine 300 mg and 0.5 mg epinephrine (Group 1) or periarticular infiltration ropivacaine 300 mg and 0.5 mg epinephrine total (Group 2) for postoperative pain management. The remaining aspect of perioperative care, including the anesthetic technique (i.e., spinal anesthetic), pre- and postoperative care will be standardized and will be similar for all patients. The duration of the involvement in the study will be until 48 hours postoperatively.

Patients in Group 1 will receive ultrasound-guided FICB after surgery. Patients in Group 2 will receive ropivacaine via periarticular infiltration prior to closing the incision.

The postoperative analgesia will be documented using the visual analog score (0=no pain, 10=worst pain). In addition, total opioid dose over the 48-h study period will be documented. Postoperative nausea will be measured using a categorical scoring system (none=0, mild=1, moderate=2, severe=3) and episodes of vomiting will be documented. Rescue antiemetics will be given to any patient who complains of nausea and/or vomiting. All variables will be assessed at 2, 6, 12, 24, and 48 hours, postoperatively by an investigator blinded to group allocation.

Eligibility Criteria:
Inclusion Criteria:

* Female ASA physical status 1-3 scheduled for total hip arthroplasty
* Age 18-80 years old
* Able to participate personally or by legal representative in informed consent in English or Spanish

Exclusion Criteria:

* History of relevant drug allergy
* Age less than 18 or greater than 80 years
* Chronic opioid use or drug abuse
* Significant psychiatric disturbance
* Inability to understand the study protocol
* Refusal to provide written consent
Study of Early Pharmaceutical Intervention for Cardiovascular Disease Prevention in Stage 1 Hypertension

STEP-Pre is to investigate the benefits of using anti-hypertensive drugs in the population with a blood pressure of 130-139/80-89 mmHg and evaluate the health economics.

STEP-Pre is a multi-center randomized clinical trial. The cohort will be randomized into the treatment group or control group with a 1:1 ratio. The treatment group will take anti-hypertensive medicine to control blood pressure under 130/80 mmHg. Both groups will take health care education.

STEP-Pre will last 4 years.


Eligibility Criteria:
Inclusion Criteria:

* Stage 1 hypertension (blood pressure is in 130-139/80-89 mmHg);
* 35 - 64 years old
* Without taking antihypertensive medicine during screening
* Signed the written informed consent

Exclusion Criteria:

* took antihypertensive medicine within the last 1 month;
* History of large atherosclerotic cerebral infarction or hemorrhagic stroke (not lacunar infarction and transient ischemic attack \[TIA\]);
* History of myocardial infarction or unstable angina or history of coronary revascularization (PCI or CABG);
* Lab tests indicating abnormal liver or kidney function (ALT ≥ 3 times the upper limit of normal value, or estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2);
* History of sustained atrial fibrillation or Ventricular arrhythmias at entry influencing the measurement of electronic blood pressure；
* Severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial;
* Dilated or hypertrophic cardiomyopathy, rheumatic heart disease, or congenital heart disease;
* Severe somatic disease such as cancer;
* Severe cognitive impairment or mental disorders;
* pregnant or breastfeeding, or planning to be pregnant;
* having organ transplantation;
* Participating in other clinical trials.
A Study of Different Dosing Schedules of Selumetinib With Cisplatin/Gemcitabine (CIS/GEM) Versus CIS/GEM Alone in Biliary Cancer

This is a phase II study (the second stage of testing a new drug or new drug combinations) to see how useful two different schedules of study drug selumetinib with cisplatin and gemcitabine are compared to cisplatin and gemticabine alone in patients with biliary cancer.

Selumetinib, an oral drug which plays an important role in the regulation of cell growth (MEK 1/2 inhibitor) has been shown to shrink tumours in patients with biliary cancer and other types of human cancers. Selumetinib has also been shown to shrink tumours when given in combination with cisplatin and gemcitabine in research studies done in animals and in some patients with biliary tract cancer. Cisplatin and gemcitabine are intravenous drugs that work by damaging DNA in tumor cells so that they are unable to grow and divide.


Eligibility Criteria:
Inclusion Criteria:

* Unresectable, recurrent or metastatic, measurable biliary tract cancer or gall bladder cancer
* No prior systemic therapy
* Performance status 0, 1, or 2
* Age 18 years or older
* Estimated life expectancy \> 3 months
* Adequate hematological, liver, renal function
* No evidence of active uncontrolled infection
* Capable of giving written consent
* Acceptable recovery of previous side effects

Exclusion Criteria:

* Progressing within 3 or 6 months of receiving certain treatments
* Prior chemotherapy for non-resectable or metastatic disease or a MEK inhibitor
* Progressing within 6 months of adjuvant treatment.
* May not have received prior chemotherapy for non-resectable/metastatic disease.
* Prior MEK, RAS, or RAF inhibitors or history of hypersensitivity to study drugs.
* Ampullary carcinoma
* Incomplete recovery from previous surgery
* Undergoing treatment with curative intent
* Prior malignancy that could interfere with the response evaluation
* Severe or uncontrolled systemic diseases or lab finding that makes it undesirable for patient to participate
* Any psychiatric or other disorder likely to impact consent
* Pregnant or breastfeeding
* Patients with significant cardiac-related issues
* History of eye-related issues.
* Systemic disease, active infection, bleeding diatheses or renal transplant, including hep B, hep C or HIV
* Receiving potent inhibitors or inducers of CYP3A4/5, CYP2C19 and CYP1A2 can continue with caution
Rapid Diagnostic Technology for AUGIB Based on Analysis of VOCs in Exhaled Breath

This study aims to develop a non-invasive and rapid diagnostic technology for acute upper gastrointestinal bleeding (AUGIB) by analyzing volatile organic compounds (VOCs) in exhaled breath. Clinically confirmed patients will be divided into three groups (no bleeding, minor bleeding, major bleeding) based on endoscopic findings. VOC profiles will be analyzed to construct a predictive model, validated for sensitivity and specificity (both targets ≥0.7). This approach addresses the limitations of endoscopy in emergency or resource-limited settings, improving diagnostic efficiency and reducing mortality.

Acute upper gastrointestinal bleeding (AUGIB) is a common emergency with an annual incidence of 100-180/100,000 and mortality of 2%-15%. Endoscopy, the gold standard, is invasive and equipment-dependent, limiting its use in primary care or emergencies. Exhaled breath VOCs analysis, a non-invasive and portable method, has been applied in other diseases but not yet explored for AUGIB.

Objectives:

1. Identify characteristic VOC profiles in exhaled breath of AUGIB patients.
2. Develop a VOC-based predictive model with sensitivity and specificity ≥0.7.
3. Establish rapid diagnostic criteria to enhance clinical decision-making.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years;
2. Clinical suspicion of AUGIB (e.g., hematemesis, melena);
3. Fasting ≥4 hours;
4. Signed informed consent.

Exclusion Criteria:

1. Severe pulmonary dysfunction or recent lung infection (within 1 week);
2. Cardiac/renal failure or disseminated intravascular coagulation;
3. Contraindications to endoscopy;
4. High-risk conditions (e.g., massive ascites);
5. Alcohol consumption within 24 hours;
6. Pregnancy.
National Survey on Care Pathway and Quality of Life in Patients With Severe Asthma According to Their Phenotype.

The SECOND SOUFFLE survey focuses on aspects of care and quality of life in a period when the landscape of severe asthma is changing in the context of biotherapies. Moreover survey on care pathway and quality of life of the asthmatic severe population according to their phenotype have never been done. It is likely to bring results in a relatively fast time, results that can lead to guide the criteria collected in RAMSES a national severe asthma cohort and future research tracks of this cohort.

The Th2 phenotype corresponds to severe asthmatic patients eligible for new subcutaneous targeted asthma therapies, which can bring about a real improvement in symptoms and quality of life. No data are available on the proportion of this patient population since the advent of biotherapies, as well as the impact on quality of life and pathway by phenotype.

The survey will be conducted using a collection of data on a dedicated questionnaire including validated questionnaires on the quality of life and the control of the asthmatic disease as well as the therapeutic observance.

The objectives of the survey are to estimate the phenotypic profile distribution of severe asthmatic patients and the proportion currently treated by biotherapies as well as the impact of the pathology on the clinical profile and quality of life of patients with severe asthma.

Investigative pulmonologists selected from university or general hospitals or from private practice will propose to their eligible patients to participate in the study. Patients informed and not opposed to participating will complete, at the end of the consultation, the dedicated questionnaire pre-filled by the pulmonologist (for the medical data required for phenotypic stratification). The questionnaires will be collected from the centers and the data centralized to establish the database. Analyzes will be done in order to stratify the populations according to their phenotype and to analyze the data globally and by subgroup.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of severe asthma for at least 12 months confirmed by a respiratory physicians and meeting the ATS / ERS definition,
* Social insured patient,
* Patient given the non-opposition

Exclusion Criteria:

* Patient participating in a therapeutic clinical trial
* Patient opposing participation in this study
* Patient with reading and comprehension difficulties not allowing him to complete the questionnaires
Artificial Intelligence-based Voice Assessment of Children and Adults Respiratory Conditions

Acute and Chronic respiratory conditions represent a leading cause of death and morbidity in children and adults worldwide. The diagnosis of bronchiolitis and asthmatic exacerbations is based on clinical, and mostly subjective, clinical parameters with moderately accurate prognostic role. Patients undergoing neck radiotherapy need invasive assessments of larynx. A simple biomarker like Voice may facilitate the management of these conditions. Recent studies showed that VOICE may be used as a good and easy biomarker to diagnose and monitor several respiratory and non-respiratory conditions. A prospective study aimed to collected VOICE and other clinical data in adults and children with common acute and chronic respiratory conditions at high impact on healthcare systems will be performed. VOICE-omic data will be linked with clinical findings generating data integration, using artificial intelligence technology to develop a Decision Support Systems to provide the basis for non-invasive personalised early recognition, diagnosis, monitoring and prognosis of patients with these conditions.


Eligibility Criteria:
INCLUSION CRITERIA:

* Children with bronchiolitis \<24 months of age clinically characterized according to the clinical definition accepted by international literature (Ralstone);
* Children with asthma according to most recent GINA guidance (Global Initiative for Asthma, 2022) aged 6-12 years in a phase of proper control or during acute exacerbations;
* Adults with upper aerodigestive tract chronic or acute clinical conditions;
* Adults with pathologic diagnosis of head and neck cancer addressed to radiotherapy with or without chemotherapy for primary treatment of the tumor.

EXCLUSION CRITERIA:

* Children with comorbidities including genetic disorders;
* Children with other chronic respiratory conditions (bronchodysplasia, cystic fibrosis);
* Children with primary immunologic diseases;
* Children with prematurity;
* Children with other respiratory conditions not part of the inclusion criteria (examples: pneumonia, tonsillitis);
* Adults over 70 years old or with neurological diseases;
* Adults with syndromic disease;
* Adults with malformations of upper aero-digestive tract;
* Adults with history of head and neck surgery or not able to sustain a vocalism for more than 3 sec.