cyrilzakka/clinical-trials huggingface dataset:
Examination of the Metabolic Effects of Direct Bile Salt Delivery to the Ileum in Humans

This project will evaluate distal intestinal bile salt administration in humans by deliving ursodeoxycholic acid (UDCA) into the terminal ileum of subjects with a pre-existing ileostomy and assessing several hormone levels following an oral glucose tolerance test compared to a placebo.

Ursodeoxycholic acid (UDCA) is currently FDA-approved for the treatment of gallstone dissolution and primary biliary cirrhosis. Other than these two diseases, exploratory research - both preclinical and clinical - has demonstrated other beneficial effects of UDCA. For example, systemic administration of UDCA for several weeks (4-6 weeks) has been shown to improve insulin sensitivity in non-diabetic, obese individuals. Whether or not these effects on insulin sensitivity may be acute in nature and are detectable by OGTT are unknown. Based on growing knowledge of bile salt receptors in the gastrointestinal tract, at least some of these effects of bile salts on metabolism appear to be mediated by receptors constitutively expressed in the terminal ileum (e.g. TGR5 receptor that is upstream of GLP-1 and insulin secretion that control blood glucose levels). Thus, metabolic effects may be inducible with acute UDCA administration directly into this region of the intestine that could be useful in screening compounds or designing future mechanistic studies. This pilot study is designed to examine the effects of UDCA on oral glucose tolerance versus a placebo in non-diabetic across a range of body mass indexes by infusing UDCA directly into the ileum of volunteering subjects with a pre-existing ileostomy and measuring hormone response. The investigators aim to recruit approximately 4-5 volunteers in a lean BMI range (18.5-25 kg/m2), overweight (\>25-29.9), class 1 obesity (\>30-35 kg/m2), and class 2 obesity (\>35-40 kg/m2) for a total of \~16-20 participants.

Eligibility Criteria:
Inclusion Criteria:

* Able to give informed consent
* Presence of an ileostomy \> 2 months
* Weight stable\* for \>2 months (i.e. no greater than 7% change in body weight the last 2 months)

Exclusion Criteria:

* Crohn's Disease
* Steroid use in the last 3 months
* Documented/known diagnosis of type 1 diabetes or type 2 diabetes, chronic liver disease, chronic kidney disease, heart failure, cardiac dysrhythmias, or familial hypercholesterolemia
* Current use of any over-the-counter or prescription oral bile salt
* Currently pregnant
* Current use of medications that are known to interact with Ursodiol
* Current or former smoker within the last year.
Health Opportunities and Promoters of Equitable Screening for Lung Cancer

The goal of this clinical trial is to promote lung cancer screening (LCS) uptake among Hispanic current and former smokers. The main questions it aims to answer are:

* What barriers do current and former Hispanic smokers face in the identification and documentation of their smoking status?
* How can digital delivery of an educational video promote LCS uptake among current and former Hispanic smokers?

Participants will receive an educational video about lung cancer screening and complete brief, self-reported surveys afterwards.

Lung cancer remains the leading cause of cancer-specific mortality in the US, and Hispanics experience worse lung cancer outcomes and die at higher rates due to advanced stage at presentation. Lung cancer screening (LCS) can save many lives through early lung cancer detection among Hispanic current and former smokers.

Still, without increasing efforts to improve smoking status disclosure and documentation and tailored interventions to promote LCS uptake among Hispanic current and former smokers, this underserved population will continue to demonstrate disparities in lung cancer survival. Based on prior research experience, Dr. Flores has adapted the NIMHD research framework by incorporating elements from Ford's evidence-based theoretical model to guide the following proposed study aims:

1) To elucidate barriers and facilitators to consistent identification and documentation of smoking status to promote LCS uptake among Hispanic current and former smokers; 2) To assess feasibility, acceptability, and reach of the digital delivery of an educational video to promote LCS uptake among Hispanic current and former smokers; 3) To explore the effect of the digital delivery of the educational video to increase interest, intent, and scheduling of LCS uptake among Hispanic current and former smokers.

Impact: The successful completion of this research will serve as a foundation for developing novel interventions to overcome disparities and advance equity in lung cancer outcomes among Hispanics and other vulnerable populations.

Eligibility Criteria:
Inclusion Criteria:

* Must be 50-80 years old
* Are a current or former smoker (quit within 15 years, or a cumulative smoking status of \> 20 pack-years)
* Not currently enrolled in Lung Cancer Screening
* Must speak English or Spanish

Exclusion Criteria:

* Has a clinical cognitive inability to provide informed consent for participation in the study or complete a brief survey
* Currently diagnosed with lung cancer
* Currently enrolled in lung cancer screening
* Have participated in the focus groups discussions from Aim 1
Preconditioning of Tumor, Tumor Microenvironment and the Immune System to Immunotherapy

PROMIT is a single arm phase 2 trial evaluating the clinical activity of immune checkpoint blockade (ICB) after administration of dacarbazine (DTIC) in patients with unresectable or metastatic, BRAF wildtype melanoma with primary resistance to anti-programmed-cell-death-1 (PD-1/PD-L1) or PD-1 plus anti-cytotoxic-T-lymphocyte antigen 4 (CTLA-4) blockade therapy. If the activity is clinically meaningful, DTIC could become a new therapeutic option to break primary resistance to immunotherapy.

PROMIT is a phase 2, single arm, open label study of DTIC followed by combined immune checkpoint blockade (ICB) therapy or PD-1/PD-L1-blockade monotherapy in adult (≥ 18 years) subjects with previously treated, unresectable or metastatic melanoma (Stage III or Stage IV melanoma as per the AJCC staging system). Subjects must be BRAF wildtype and must have shown primary resistance to ICB. Fresh tumor tissue from an unresectable or metastatic site of disease must be available.

Subjects will be treated with DTIC 850 mg/m² day 1 and 21 i.v. (DTIC phase). Afterwards, patients will receive combined ipilimumab (3 mg/kg) and nivolumab (1 mg/kg) 4 times every 3 weeks i.v. OR nivolumab 240 mg every 2 weeks OR pembrolizumab 200 mg every 3 weeks (ICB re-exposure phase; EMA-approved dosing scheme). By the end of the ICB phase, response will be documented (primary endpoint). A safety follow-up for treatment-related adverse events will be performed until 30 days after the last dose of combined ICB. Patients will be followed for survival every 12 weeks after the end of the combined ICB phase (second primary endpoint). Tumor and blood samples will be assessed over the course of the study to evaluate changes in tumor, tumor microenvironment and immune system.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed metastatic melanoma
2. Progression after checkpoint inhibitor therapy (PD-1/PD-L1 or PD-1 + CTLA-4 blockade)
3. Accessible tumor metastases
4. ECOG 0 or 1
5. Adequate organ function

Exclusion Criteria:

1. Uvea melanoma, mucosal melanoma
2. Previous chemotherapy in metastatic disease
3. Previous response to checkpoint inhibitor therapy (PD-1/PD-L1 or PD-1 + CTLA-4 blockade) in metastatic disease
4. BRAF V600 mutation
5. Active brain metastases
6. Autoimmune disease requiring more than 10 mg prednisolone daily or other immunosuppressive drugs
Waiting for Stapler Firing in Laparoscopic Sleeve Gastrectomy

Complications will be evaluated by waiting 30 seconds after firing 30 seconds during stapler compression while performing sleeve gastrectomy.

Those with a BMI between 35.0 and 39.90 and those with an obesity-related comorbidity, and all morbid obesity patients with a BMI of 40.0 and above, were previously adequate for at least 6 (six) months with non-surgical (diet, medication, exercise, etc.) methods. Patients with morbid obesity who could not lose weight and who were unsuccessful will be included in the study by signing an informed consent form for the operation and study, after being evaluated by the "obesity council" consisting of endocrinology, psychiatry, anesthesiology, dietitian and general surgery, and approved for bariatric surgery. Waiting will be made for patients whose patient file number has an odd number in the last digit, and no waiting will be made for patients whose last digit is an even number. At the time of the operation, the patients will be put on thromboembolic stockings and the reverse trendelenburg position will be given and the operation will be started with the laparoscopic method. After the stomach is mobilized from the adjacent organs and structures, the 38F gastric tube will be advanced to the stomach, the tissue will be closed with a 60 mm laparoscopic stapler, waited for 30 seconds, and then ignition will be performed. After the stapler is fired, a waiting period of 30 seconds will be waited and it will be removed from the tissue. In this first case, whether there is bleeding or not, at how many points, whether additional intervention is required or not will be recorded. At the end of the operation, the gastric tube will be withdrawn, and the stomach will be filled with 120 cc saline colored with methylene blue to check if there is any leakage. If there is no leakage, a gastric drainage drain will be placed and the operation will be completed. Postoperative 24 - 48 . After discharge, the patient will be called for routine control on the 1st week, 15th day and 30th day after discharge.

Eligibility Criteria:
Inclusion Criteria:

* Among the patients between the ages of 18-65 who will undergo morbid obesity operation;

  1. Body mass index (BMI): 35.0-39.9 and those with at least one obesity-related comorbidity
  2. Patients with BMI: 40.0-49.9

Exclusion Criteria:

* a-Applicants for revision surgery, b- Patients with a history of thromboembolism, c- Patients with known coagulation disorders
Effects of Efficient Lifestyle Counseling Method on the Risks of Cardiovascular Disease in Health Care Center Patients

The aim of the trial is to study the effect of a lifestyle change program in patients with obesity and risk of cardiovascular diseases. The main focus is to motivate and support lifestyle changes.

Two different group counseling methods (intensive and standard) with or without internet support will be compared. Thus, the patients will be randomized into four arms. Patients will be recruited from local general practice teams. The intensive lifestyle counseling consists of 12 group counseling sessions and 2 personal counseling sessions. The standard counseling consists of 4 group sessions. The internet-based counseling contains aspects of cognitive behavior therapy and persuasive design system and consists of weekly reminders, tasks, self-monitoring, and reflection.

The main outcome is the decrease in body weight. Secondary outcomes are changes in eating behavior, eating habits, components of metabolic syndrome (waist circumference, plasma lipid and glucose values), and calculated scores of cardiometabolic condition, cardiovascular risk and adiposity.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index 30 to 40 kg/m2
* + 2 risk factors of cardiovascular diseases:

  * Elevated blood pressure or hypertension
  * High LDL or hypocholesterolemic drug
  * Low HDL or hypocholesterolemic drug
  * Elevated triglyceride value or hypolipidemic drug
  * Elevated glucose value or diabetes medication
  * Smoking
* Access to email and internet

Exclusion Criteria:

* Untreated hypothyroidism
* Oral corticosteroid treatment
* Pregnancy and lactation
* Angina pectoris
* Cardiac insufficiency
* Coronary Heart Disease
* Inability to speak Finnish
* Anticipated lack of compliance
Presumptively Initiating Vaccines and Optimizing Talk With Motivational Interviewing (PIVOT With MI)

The overall goal of this project is to determine whether a novel and innovative provider communication strategy is effective in improving vaccine acceptance among vaccine-hesitant parents (VHPs) and visit experience among VHPs and their health care providers.

The primary goal of this covariate constrained, cluster randomized controlled trial is to evaluate the effectiveness of an innovative provider communication strategy (PIVOT-MI) intervention in improving provider-parent vaccine discussions and increasing vaccine acceptance. Providers at intervention clinics will be trained to use the PIVOT-MI strategy in which a presumptive format is used to initiate the childhood vaccine recommendation with all parents, followed by use of motivational interviewing (MI) with parents who voice resistance to that recommendation. Providers at control clinics will deliver care as usual.

Specific aims are to evaluate the impact of PIVOT-MI, relative to control, on (1) child's immunization status; (2) parent-rated visit experience with their child's provider; and (3) change in provider experience of the vaccine discussion with vaccine-hesitant parents.

Eligibility Criteria:
Inclusion Criteria:

* Parents: must be English or Spanish speaking, ≥18 years old, have an infant ≤18 months old, have legal guardianship of the infant, and is receiving pediatric care at an enrolled clinic
* Providers: All providers at participating study practices will be eligible to participate.

Exclusion Criteria:

* Parents: not English or Spanish speaking, under 18 years old, have an infant older than 18 months, not the legal guardian of the infant, and/or having a child who is not receiving pediatric care at an enrolled clinic.
* Providers: Providers who are not at participating study practices.
A Study for Older Adults With Acute Lymphoblastic Leukaemia

The NCRI Adult ALL sub-group propose to collaborate with the Dutch/Belgian group HOVON to carry out a prospective, non randomised multi-arm study (including a choice of regimen intensity) to investigate the safety, tolerability and feasibility of a standardised therapy protocol for patients ≥ 60 years old with de novo ALL. The overall aim is define a basic standard of care upon which trials of novel therapies will be based in future. The design of the study will enable collection of a comprehensive dataset regarding the clinical outcome, Complete Response Rate (CR) and Minimal Residual Disease (MRD) response rates in a previously completely uncharacterised population, thus providing the essential platform for designing future randomised advanced phase studies in which new therapeutic approaches and novel therapies can be prospectively investigated.

The study will

1. establish baseline expectations for Event Free Survival (EFS), Overall Survival (OS), MRD responses and quality of life measures for older patients of all ages and pre-morbid states;
2. disclose how best to use knowledge of pre-morbid characteristics to apply the appropriate intensity of therapy in order to balance the best disease related outcomes against quality of life;
3. establish national standards of care for this patient group;
4. provide the essential platform for careful design of future randomised advanced phase studies of new therapeutic approaches and agents.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 60 with Acute Lymphoblastic Leukaemia (ALL) OR ≥ 55 with Acute Lymphoblastic Leukaemia (ALL) unsuitable for the UKALL14 or HOVON 100 trial
* Newly diagnosed, previously untreated ALL (a steroid pre-phase of 5-7 days may be given before trial registration))
* Willing and able to give consent

Exclusion Criteria:

* Known HIV infection
* Blast transformation of CML
* Mature B-cell leukaemia i.e. Burkitts disease t(8,14)(q24 ;q32) and variant c-myc translocations e.g. t(2;8)(p12 ;q24), t(8;22)(q24;q11)
* Women who are pregnant or lactating
SP Robotic Versus VATS Anatomical Pulmonary Resection for Patients With NSCLC

Single-POrt Robotic-assisted thoracic surgery versus single-port video-assisted Thoracic Surgery major pulmonary resection for patients with non-small cell lung cancer (SPORTS trial): a single-center, a single blinded, randomized controlled trial

Investigators initially began single-port robotic thoracic surgery using the SP robotic system for simple procedures, such as thymectomy and mediastinal mass excision. As their expertise grew, they expanded to more complex procedures, including major pulmonary resection and esophagectomy. However, the long-term outcomes of SP robotic anatomical pulmonary resection using the SP robotic system have not yet been studied.

The aim of this study is to compare the short-term and long-term outcomes of SP robotic anatomical pulmonary resection using the SP robotic system with those of single-port video-assisted thoracoscopic surgery (SP-VATS) anatomical pulmonary resection.

This trial is a single-center, single-blinded, randomized controlled trial. Participants will be randomized at a 1:1 ratio to either single-port video-assisted thoracoscopic surgery (SP-VATS) or single-port robotic thoracic surgery.

Eligibility Criteria:
Inclusion Criteria:

* Candidate for anatomical pulmonary resection (segmentectomy or lobectomy) via minimally invasive thoracic surgery (RATS or VATS) for patient with non-small cell lung cancer or suspected malignant lesion.
* Age ≥ 18 years
* Patients who can comply with the requirements of the clinical trial and who, or their legal representatives, provide written consent before the start of the clinical trial
* Patients with the nationality of South Korea
* American Society of Anesthesiologists score 1-3.
* Clinical stage I, II or IIIa non-small cell lung cancer (NSCLC)

Exclusion Criteria:

* Patients who require surgery for accompanying other organ diseases
* Tumor invasion into the chest wall, diaphragm, another lobe or diaphragm
* Patients who are considered unsuitable based on the researcher's judgment
* Patients with cognitive impairments who are unable to understand the instructions and informed consent of this study
* Patients who specifically desire a certain surgical method (robotic, thoracoscopic, open thoracotomy)
* Patients who previously undergone a thoracic surgical procedure in the hemithorax to be operated on
* Pathological results other than NSCLC (ex, benign nodules, metastatic lung cancer, SCLC)
* Patients who received neoadjuvant therapy.
* Candidate for pneumonectomy, bilobectomy, lobectomy plus segmentectomy, non-anatomic resection (ex, wedge resection).
* History of other cancers in the past 5 years.
ConfocAl endomicroSCopy bAsed Diet Trial in IBS

After a thorough baseline evaluation, IBS patients will be exposed to nutrients while undergoing confocal laser endomicroscopy (CLE). Patients presenting an acute mucosal reaction upon nutrient exposure will be instructed to exclude their respective trigger nutrient or a nutrient without mucosal reaction (=sham diet) from their diet for 4 weeks in a randomized, blinded crossover fashion.

The aim of the trial is to assess the symptomatic response to the targeted diet and further elucidate mechanisms underlying the acute mucosal reactions observed in CLE upon nutrient exposure.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 y/o (70 years included)
* Male or female subjects
* IBS-D and IBS-M (i.e. IBS-non-C) according to Rome IV criteria
* Moderate to severe symptom severity as defined by the Irritable bowel syndrome severity scoring system (IBS-SSS) (i.e. IBS-SSS \>175 points)
* Provide written informed consent to participate in the study
* Women of child-bearing potential agree to apply a highly effective method of birth control during the entire duration of the trial. Highly effective birth control is defined as those which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as implants, injectables, combined oral contraceptive method, or some intrauterine devices (IUDs), sexual abstinence, or vasectomized partner. Women of non-childbearing potential may be included if surgically sterile (tubal ligation or hysterectomy) or postmenopausal with at least 2 year without spontaneous menses.
* Subjects who are capable to understand the study and the questionnaires, and to comply with the study requirements.

Exclusion Criteria:

* - Pregnant or breastfeeding women
* History of major surgery of the gastrointestinal tract (cholecystectomy and uncomplicated appendectomy are allowed)
* Symptoms predominantly associated with functional dyspepsia or gastro-esophageal reflux disease
* Immunoglobuline E (IgE)-mediated food allergies identified by immunocap blood tests or skin prick testing
* Known underlying organic gastrointestinal disease
* Current or recent use of NSAIDs, proton-pump inhibitors, systemic histamine-receptor antagonists, mast cell stabilizers, corticosteroids, opioids (need to be stopped at least 2 weeks). Use of antibiotics in the past 6 weeks.
* Allergy to Fluorescein, Xylocaine or Propofol
* Known celiac disease
* Following a diet interfering with the study diet in opinion of the investigator
Left Main Coronary Artery Stenosis and Angioplasty With Taxus Stent

The purpose of this study is to determine whether percutaneous coronary angioplasty with Taxus drug eluting stent is safe and effective in the treatment of unprotected left main coronary artery disease associated to other coronary lesions or not.

Coronary artery bypass graft is the reference treatment of left main coronary artery disease. With the advancements of technology and particularly drug-eluting stents, in-stent restenosis has dramatically decreased and now it is possible to extend indications of complexes lesions such as left main coronary artery stenoses. In these particular situations,some centers performed percutaneous coronary angioplasty (PCI) with drug-eluting stents with acceptable results in terms of safety and efficacy. However, these procedures are performed at isolated sites and are not evaluated in multicenter trial.The aim of this study is to assess the safety and efficacy of this PCI with Taxus-stent in a french multicenter trial and to evaluate clinical and angiographic outcome of these patients at long-term follow-up.

Eligibility Criteria:
Inclusion Criteria:

* The patient must be \> or = 18 years of age
* Patient must provide written informed consent prior to the procedure using a form that is approved by the local Ethics Committee
* Aspirin + Clopidogrel \> or = 12 hours before percutaneous coronary intervention (PCI)
* Documented evidence of ischemic heart disease (clinical,biological or ECG) with unprotected left main coronary artery stenosis \> or = 50% associated to other coronary lesions or not responsible of stable or unstable coronary syndrome above 48 hours
* The target reference vessel diameter must be \> or = 2.5 mm
* Unprotected left main coronary artery disease eligible by coronary stenting

Exclusion Criteria:

* Restenosis lesion in left main coronary artery
* Known allergies to the following: aspirin, clopidogrel,ticlopidine,contrast agent or drug similar to paclitaxel
* Acute coronary syndrome \< 48 hours
* Impaired renal function (creatinine \> 180 ùmol/l) at the time of treatment
* Life expectancy less than 36 months
* Female of childbearing potential without reliable birth control
* Currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the study endpoints