cyrilzakka/clinical-trials huggingface dataset:
Safety of Endoscopic Resection of Large Colorectal Polyps: A Randomized Trial.

The effectiveness of colonoscopy in reducing colorectal cancer mortality relies on the detection and removal of neoplastic polyps. Because the risk of prevalent cancer and of transition to cancer increases with polyp size, effective and safe resection of large polyps is particularly important. Large polyps ≥20mm are removed by so-called endoscopic mucosal resection (EMR) using electrocautery snares. Resection of these large polyps is associated with a risk of severe complications that may require hospitalization and additional interventions. The most common risk is delayed bleeding which is observed in approximately 2-9% of patients. A recent retrospective study suggests that closure of the large mucosal defect after resection may decrease the risk of delayed bleeding. However, significant uncertainty remains about the polypectomy techniques to optimizing resection and minimizing risk. Important aspects that may affect risk include clipping of the mucosal defect and electrocautery setting.

Aim 1. The primary aim of the study is to compare the rate of delayed bleeding complications in patients undergoing endoscopic resection of large polyps between:

* A) Closing the mucosal defect after resection (Clip group) and
* B) Not closing the mucosal defect after resection (No clip group).

Aim 2. The secondary aim of the study is to compare the rate of overall complications in patients undergoing endoscopic resection of large polyps between two cautery settings:

* A) Low power coagulation and
* B) Endocut.

Eligibility Criteria:
Inclusion Criteria:

* Any patient ≥18 and ≤89 who presents for a colonoscopy and who does not have criteria for exclusion
* Patients with a ≥20mm non-pedunculated colon polyp

Exclusion Criteria:

* Patients with known (biopsy proven) invasive carcinoma in a potential study polyp
* Pedunculated polyps (as defined by Paris Classification type Ip or Isp)
* Patients with ulcerated depressed lesions (as defined by Paris Classification type III)
* Patients with inflammatory bowel disease
* Patients who are receiving an emergency colonoscopy
* Poor general health (ASA class\>3)
* Patients with coagulopathy with an elevated INR ≥1.5, or platelets \<50
* Poor bowel preparation
* Pregnancy
Replication of the INSPIRE Trial in Healthcare Claims Data

Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to replicate, as closely as is possible in healthcare insurance claims data, the trial listed below/above. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice. Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding.

Eligibility Criteria:
Inclusion Criteria:

* Age between 40-80 years \[0,0\] days
* Diagnosis of COPD \[all available data, 0\] days
* Clinical history of at least 1 COPD exacerbation \[all available data, -43\] days

Exclusion Criteria:

* COPD exacerbation \[-42, 0\] days
* Asthma, eczema, atopic dermatitis, allergic rhinitis \[-180, 0\] days
* Known respiratory disorder other than COPD e.g. pulmonary fibrosis or interstitial lung disease (ILD), sarcoidosis, lymphangioleiomyomatosis, primary/pulmonary tuberculosis, cystic fibrosis, pulmonary hypertension/other pulmonary heart disease, lung/pulmonary malignancies, alpha-1 antitrypsin deficiency, pneumoconioses and other lung diseases due to external agents \[all available data, 0\] days
* Narrow angle glaucoma or prostatic hyperplasia or obstruction of the neck of the bladder \[-180, 0\] days
* At least one 30-day supply prescription claims for oral alfuzosin, doxazosin, tamsulosin, silodosin, finasteride 5 mg, dutasteride \[-180,0\] days
* Lung transplant or lung volume reduction surgery (LVRS) \[all available data, 0\] days
* Daily long term oxygen therapy (LTOT) \[all available data, 0\] days
* Beta-blockers (except eye drops) \[-180, 0\] days
* Evidence of alcohol, drug or solvent abuse \[-180, 0\] days
* Use of salmeterol, tiotropium and fluticasone containing inhaler use \[-180, 0\] days
Survey of Lipid Goal Attainment and Mortality in Patients With High Cardiovascular Risk in Thailand

The first phase of the study is a hospital-based cross-sectional, epidemiological survey. The required sample size is 1,260 patients from 50 hospitals across Thailand. Each of the hospital will enroll 10 to 40 consecutive patients, depending on case availability on the date conducting the survey, with dyslipidemia and classified as high risk as defined by the protocol. Lipid levels will be based on serological analysis conducted by a local laboratory.

For the second phase, each subject will be followed for survival status at 36 months after enrollment. Such follow-up will be done by searching the Thai National Vital Event Registration Database using subjects' Population Identification Number. All activities regarding case selection and data collection will be done by well trained clinical research associates (CRAs). The CRAs are from Khon Kaen University where the Statistical Coordinating Center (SCC) for this project is based and are independent of the investigator. Random auditing visits will also be performed by auditors independent of the SCC. These are to ensure not only high quality data but also protecting right and well being of subjects.


Eligibility Criteria:
Inclusion Criteria:

* Evidence of high cardiovascular risk
* Dyslipidemic currently being treated with the same therapy for at least 3 months

Exclusion Criteria:

* Recent major trauma(within 12 weeks)
* Recent surgery requiring anesthesia including coronary bypass graft(within 12 weeks)
* Acute or abrupt change(within 1 month) in usual diet
* Pregnancy, breast-feeding currently, or postpartum within the last 6 months
CD19 CAR-T Cells for Patients With Relapse and Refractory CD19+ B-ALL.

This is a single center, single arm, open-lable phase 1 study to determine the safety and efficacy of CD19-CAR-T cells in patients with relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL).

In this single-center, open-label, nonrandomized, no control, prospective clinical trial, no less than 18 CD19+ B-cell relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL) patients will be enrolled. Side effects of CD19 CAR T cells therapy will be monitored. The purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells therapy in patients with R/R B-ALL.

Eligibility Criteria:
Inclusion Criteria:

1. More than 1 year;
2. CD19 positive B-cell acute lymphoblastic leukemia;
3. Important organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥50%, no obvious abnormality in ECG; blood oxygen saturation ≥90%; creatinine clearance calculated by Cockcroft-Gault formula ≥40ml/min; ALT and AST≤ 5 times normal range, total bilirubin ≤ 34.2 μmol / L.
4. Expected to survive for more than 3 months;
5. Informed consent is signed by a subject or his lineal relation.

Exclusion Criteria:

1. Recent or current use of glucocorticoid or other immunosuppressor;
2. Uncontrolled active infection, HIV infection, syphilis serology reaction positive;
3. Has a graft-versus-host response and requires the use of immunosuppressants；
4. Drug uncontrollable central nervous system leukemia；
5. Pregnant or lactating female；
6. The patient did not agree to use effective contraception during the treatment period and for the following 1 year；
7. A history of other malignant tumors;
8. The investigator believes that there are other factors that are not suitable for inclusion or influence the subject's participation or completion of the study.
Effects of Intensive Statin Treatment on Left Ventricular Function

First acute anterior myocardial infarction in patients with primary PCI preoperative and postoperative 30 days intensive dose atorvastatin statin therapy compared with conventional -dose therapy , patients can improve left ventricular function , reduce major adverse cardiovascular events .


Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age
2. the first time clinical diagnosis of acute anterior myocardial infarction , the time of onset ≤ 12 hours ,intends underwent emergency PCI
3. informed consent

Exclusion Criteria:

1. Taking , or the need for long-term use of statins is greater than the initial dose
2. treated with PCI again within a mouth
3. active liver disease or liver dysfunction
4. the diagnosis of myopathy
5. severe renal insufficiency ( serum creatinine \> 178umol / L )
6. Statin drug allergy or had a serious adverse reaction
7. severe aortic stenosis or mitral stenosis , hypertrophic obstructive cardiomyopathy , pericardial disease
8. pregnancy
9. malignancy or any other end-stage diseases result in a life expectancy of \< 6 months
10. be participating in other clinical studies
11. not suitable for inclusion of the other cases
12. not treated with PCI
Ondansetron HCl Orally Disintegrating Tablets Under Fasting Conditions

The objective of this study was to compare the relative bioavailability of the test formulation of Ondansetron HCl with the already marketed reference formulation Zofran ODT under fasting conditions in healthy, non-smoking adult subjects.

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Eligibility Criteria:
Inclusion Criteria:

* All subjects selected for this study will be non-smokers at least 18 years of age.
* Subjects will have a BMI (body mass index) of 30 or less.

Exclusion Criteria:

* Subjects with a significant recent history of chronic alcohol consumption, drug addiction, or serious gastrointestinal, renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma, diabetes, psychosis or glaucoma will not be eligible for this study.
* Subjects whose clinical laboratory test values are greater than 20% outside the normal range may be retested. If the clinical values are outside the range on retesting, the subject will not be eligible to participate in the study unless the clinical investigator deems the result to not be significant.
* Subjects who have a history of allergic responses to the class of drug being tested will be excluded from the study.
* Subjects who use tobacco in any form will not be eligible to participate in the study. Three months abstinence is required.
* All subjects will have urine samples assayed for the presence of drugs of abuse as part of the clinical laboratory screening procedures and at each dosing period check-in. Subjects found to have urine concentrations of any of the tested drugs will not be allowed to participate.
* Subjects should not have donated blood and/or plasma for at least thirty (30) days prior to the first dosing of the study.
* Subjects who have taken any investigational drug within thirty (30) days prior to the first dosing of the study will not be allowed to participate.
* Female subjects who are pregnant, breast-feeding, or who are likely to become pregnant during the study will not be allowed to participate. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable barrier method (e.g. condom, IUD) of contraception during the course of the study (first dosing until last blood collection) or they will not be allowed to participate. Subjects who have used implanted or injected hormonal contraceptives anytime during the 180 days prior to study dosing or oral hormonal contraceptives with in 14 days of dosing will not be allowed to participate.
* All Female subjects will be screened for pregnancy at check-in each study period. Subjects with positive or inconclusive results will be withdrawn from the study.
* Subjects who do not tolerate venipuncture will not be allowed to participate.
Effect Inverse Ratio Ventilation on Arterial Oxygenation and Respiratory Mechanics During lapaLAR

Changes of inspiration: expiration ration from 1:2 to 1:1 could improve the arterial oxygenation and respiratory mechanics

Inverse ratio ventilation already known as effective to improve the oxygenation and respiratory mechanics in the ARDS patients. Recently, there were report of decrease in airway pressure and improve in respiratory compliance during inverse ration ventilation undergoing one lung ventilation. We hypothesized that changes of inspiration and expiration ratio from 1:2 to 1:1 could improve the arterial oxygenation and respiratory mechanics in the patients who undergoing laparoscopic low anterior resection. However, prolonged inspiratory time might compromise cerebral perfusion pressure due to an elevation in central venous pressure and concomitant reductions in mean arterial pressure.

Eligibility Criteria:
Inclusion Criteria:

* colorectal cancer

Exclusion Criteria:

* obesity (BMI\>35), uncontrolled hypertension, coronary artery disease, uncompensated cardiovascular disease, current respiratory disease, open procedure
M7824 Versus Pembrolizumab as a First-line (1L) Treatment in Participants With Programmed Death-ligand 1 (PD-L1) Expressing Advanced Non-small Cell Lung Cancer (NSCLC)

The purpose of the study is to evaluate the efficacy and safety of bintrafusp alfa (M7824) compared with pembrolizumab in participants with advanced NSCLC with high PD-L1-tumor expression, with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. The Phase III adaptive design allows for the option to recruit up to 584 patients based on pre-specified rules.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of advanced NSCLC
* Have not received prior systemic therapy treatment for their advanced/Stage four NSCLC. Completion of treatment with cytotoxic chemotherapy, biological therapy, and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as therapy was completed at least 6 months prior to the diagnosis of metastatic disease. Confirmation of resolution of toxic effects of previous neoadjuvant/adjuvant chemotherapy therapy to Grade less than or equal to 1. For radiation toxicity or prior major surgeries, participants should have recovered from side effects and/or complications
* Have measurable disease based on RECIST 1.1
* Have a life expectancy of at least 3 months
* Availability of tumor tissue (less than 6 months old) before the first dose is mandatory to determine PD-L1 expression level prior to enrollment
* PD-L1 high status as determined by central testing
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Participants with nonsquamous NSCLC histologies whose tumor harbors any of the following molecular alterations and targeted therapy is locally approved: epidermal growth factor receptor (EGFR) sensitizing (activating) mutation, anaplastic lymphoma kinase (ALK) translocation, ROS1 rearrangement, or BRAF V600E mutation
* Has received major surgery within 4 weeks prior to the first dose of study intervention; received thoracic radiation therapy of greater than 30 units of gray (Gy) within 6 months prior to the first dose of study
* Known severe hypersensitivity to investigational products (M7824 or pembrolizumab), or any components in their formulations
* Previous malignant disease (other than the target malignancy to be investigated in this study) within the last 3 years
* Other protocol defined exclusion criteria could apply
The Effect of Transcatheter VSD Closure on Children's Appetite, Hormones and Growth

In this study; Changes in appetite, hormones and growth of ventricular septal defect patients treated with non-surgical method were evaluated.

The study included 20 patients whose ventricular septal defect closed percutaneously and 26 children as control group. The symptoms, anthropometric measurements and laboratory tests of patient group were recorded at initial, 1st month and 6th months after closure.

Anthropometric measurements; weight for age (WFA), height for age (HFA), body mass index (BMI) and their z scores, triceps skinfold thickness (TSF) and mid-upper arm circumference (MUAC) were recorded on admission. Patients with weight for height z score less than -2 were defined as malnutrition.

Questions about the symptoms like appetite, weight gain, frequency of illness, rate of breathing, fatigue were asked to all parents at initial. These questionnaires15 and visual analogue scale (for appetite) were repeated at 1st and 6th month visits.

During the initial evaluation, approximately 6 ml of venous blood samples were taken between 9:00-10:00 am after an average of 10 hours fasting. On the same day, IGFBP-3, Ghrelin and leptin,fasting blood glucose, insulin, IGF-1, IGFBP-3, aspartate aminotransferase (AST) and alanine aminotransferase (ALT), total protein, and albumin were measured.

Anthropometric measurements and laboratory tests were repeated at 1st and 6th month visits.

Eligibility Criteria:
Inclusion Criteria:

Pediatric patients who underwent transcatheter VSD closure

Exclusion Criteria:

* Chromosomal abnormalities
* Additional systemic disease
* Systemic infections
Feasibility of Using the Livongo-Insulia Study App for Patients With Type 2 Diabetes [Pilot Study]

The Livongo-Insulia Study App Pilot Study (LISA Pilot) is a 3-month, prospective, interventional study. The purpose of this pilot study is to evaluate the feasibility of using the Livongo-Insulia Study App for individuals with type 2 diabetes using basal insulin. This will be assessed by measuring the impact of the Livongo-Insulia Study App on glycemic control for these individuals.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Lives in the U.S.
* Able to speak, read and write in English
* Diagnosed with type 2 diabetes
* Currently treated with long-acting basal insulin analog (Lantus, Levemir, Toujeo, Basaglar, Tresiba U-100) and taking 1 injection per day
* Takes a daily dose ≤ 0.75 units/kg
* Estimated A1c ≥ 8% (based on existing Livongo data)
* Has been enrolled in Livongo for at least 12 weeks
* Uses an iPhone compatible with Insulia's compatibility matrix (iPhone 5 or higher; iOS 8 or newer)
* Willing to complete study questionnaires
* Willing to complete at-home A1c kits
* Willing to check before breakfast blood glucose at least once per day

Exclusion Criteria:

* Diagnosis of type 1 diabetes
* Currently using a long-acting basal insulin analog that is not supported by Insulia
* Currently using rapid-acting, short-acting, or intermediate-acting or premixed insulins
* Currently pregnant or planning pregnancy
Evaluation of the Effect of AVE0657 on Obstructive Sleep Apnea

The primary objective of this study is to assess the activity of 4 escalating doses of AVE0657 in comparison to placebo in patients with Obstructive Sleep Apnea Hypopnea Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed with Obstructive Sleep Apnea Hypopnea Syndrome based on International Classification of Sleep Disorders

Exclusion Criteria:

* Subjects having been treated by Continuous Positive Airway Pressure, oral appliance during 4-weeks prior to randomization
* Chronic respiratory disease or inadequate respiratory parameters
* Body Mass Index (BMI) of ≤20 kg/m² or ≥35 kg/m²
* Surgical procedure to correct apnea within the last three months.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Retrospective Study of 110 Cases of Uterine Rupture to Determine Obstetric and Neonatal Complications

This study has for objective to collect medical data from patients with uterine rupture at the childbirth.

This is a retrospective study, gathering data of five maternity in the department of Val d'Oise in France, during 13 years (between 01/01/2000 an 31/12/2013).

The incidence of uterine rupture increases with increasing cesarean rates. It occurs at a rate of 0.08% across all childbirths in France, and 0.5 to 1% of the childbirths on cicatricial uterus in France.

Although the risk factors are known, it is usually unexpected. This is a serious complication for the mother (mortality \<1%, severe morbidity at 15% ) and for the child (mortality for 3 to 6 % for childbirth at term, neonatal asphyxia for 6 to 15%) that can occur during pregnancy or during labor.

Eligibility Criteria:
Inclusion Criteria:

* Childbirth with uterine rupture

Exclusion Criteria:

* Childbirth in a maternity which do not participate to the study
A Comparison of Critical Errors, Overall Errors, Training/Teaching Time, and Preference Attributes of the ELLIPTA Versus BREEZHALER Dry Powder Inhalers (DPIs) in Adult Participants With Asthma

This study aims to provide data in adult participants with mild to moderate asthma to assist healthcare professionals (HCPs) in assessing various attributes of ELLIPTA and BREEZHALER DPIs, by comparing the incidence of critical and overall errors, participant preference, willingness to continue with the inhaler and time to correct use. ELLIPTA® is a registered trademark of GlaxoSmithKline (GSK) and BREEZHALER® is a registered trademark of Novartis.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be aged 18 years or older at the time of signing the informed consent.
* Participants who have a confirmed mild or moderate asthma diagnosis as per Global Initiative for Asthma (GINA), 2020.
* Participants must be on asthma maintenance therapy (Inhaled corticosteroids \[ICS\] or ICS/ Long acting beta 2-agonist \[LABA\]) for at least 12 weeks prior to study participation.
* Participants must be naïve to both the ELLIPTA and BREEZHALER inhalers.
* Females who are not pregnant or not planning a pregnancy during the study or not Lactating.
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria:

* Concurrent diagnosis of chronic obstructive pulmonary disease (COPD) or other respiratory disorders.
* History of hypersensitivity to any components of the study inhaler (e.g., lactose). In addition, participants with a history of severe milk protein allergy that, in the opinion of the study physician, contraindicates participation will also be excluded.
* Historical or current evidence of clinically significant or rapidly progressing or unstable disease that, in the opinion of the investigator, would put the safety of the participant at risk through participation, or which would affect the analysis if the disease/condition exacerbated during the study.
* Drug/alcohol abuse: Participants with a known or suspected alcohol or drug abuse, which in the opinion of the investigator could interfere with the participant's proper completion of the protocol requirement.
* A participant will not be eligible for this study if he/she is an immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator, as well as employees of GSK or Novartis.
* Inability to Read: In the opinion of the investigator, any participant who is unable to read and/or would not be able to complete a questionnaire and understand verbal instructions.
* Medical and physical conditions that in the opinion of the investigator could impact the ability of the participant to manipulate the inhaler.