cyrilzakka/clinical-trials huggingface dataset:
Senolytics To slOw Progression of Sepsis (STOP-Sepsis) Trial

The long-term goal is to test the clinical efficacy of senolytic therapies to reduce progression to and severity of sepsis in older patients. The central hypothesis is that a threshold burden of SnCs predisposes to a SASP mediated dysfunctional response to PAMPs, contributing to a disproportionate burden of sepsis in older patients. The study hypothesizes timely treatment with fisetin will interrupt this pathway.

A multicenter, randomized, adaptive allocation clinical trial to identify the most efficacious dose of the senolytic fisetin to reduce the composite cardiovascular, respiratory, and renal sequential organ failure assessment score at 1 week, and predict the probability of success of a definitive phase III clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Age \>=65 years
* Primary diagnosis of acute infection (per investigator judgment)
* SOFA \>1
* Admission order to the hospital
* Expected length of stay \>=48 hours (per investigator judgment)

Exclusion Criteria:

* Admission to the ICU
* Vasopressors, mechanical ventilation, or dialysis
* Comfort care only
* Total bilirubin \>3X or AST/ALT \>4x upper limit of normal
* eGFR \< 25 ml/ min/ 1.73 m2
* Hemoglobin \<7 g/dL; white blood cell count ≤ 2,000/mm3; absolute neutrophil count ≤1 x 10\^9/;, or platelet count ≤ 40,000/μL
* Known HIV, Hepatitis B, or Hepatitis C
* Invasive fungal infection (per investigator judgment)
* Uncontrolled effusions or ascites (per investigator judgment)
* New/active invasive cancer except non-melanoma skin cancers
* Known hypersensitivity or allergy to Fisetin.
* Active treatment with potential drug-drug interactions
* Enrolled in another sepsis clinical trial
A Comparison of Bowel Preparation for Colonoscopy Between Digestive Physicians and Non-digestive Physicians

The diagnostic accuracy of colonoscopy depends on the quality of bowel preparation, which is a critical element associated with the diagnostic yield, difficulty, time required, and the completeness of colonoscopy. The non-digestive physicians seemed to have a lower quality of bowel preparation compare to the digestive physicians. Therefore, investigators planned to evaluate the risk factors for suboptimal intestinal preparation in outpatients from the perspective of digestive doctors and non-digestive.


Eligibility Criteria:
Inclusion Criteria:

* All outpatients who have already completed the colonoscopy during December 2019 and October 2020.

Exclusion Criteria:

* Patients with incomplete critical information, primary outcome, and baseline characteristics missing as well as examinations in hospitalized patients were excluded.
Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adults

The purpose of this study is to determine the single-dose pharmacokinetics of the investigational drug PL 3100 following oral administration to healthy volunteers and to compare the pharmacokinetic profiles of PL 3100 and naproxen at a prescription dose.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years, inclusive.
* Subject has a Body Mass Index (BMI) between 20 and 32, inclusive.
* Normal physical examination as determined by the Investigator.
* Normal clinical laboratory test results or clinically insignificant results as determined by the Investigator during the screening visit.
* If female and of child-bearing potential, the subject must have a negative pregnancy test and is not nursing.
* If female and of child-bearing potential, the subject must agree to use adequate birth control for the duration of the study.

Exclusion Criteria:

* Subject has a history of chronic alcohol consumption or abuse of narcotics or alcohol.
* Subject has had an acute illness within 5 days of study medication administration.
* Subject is currently participating, or has participated within 30 days prior to study entry, in an investigational drug study.
* Subject has hypersensitivity or contraindications to naproxen, ibuprofen, or other NSAID.
Study of Surufatinib as Second-line Treatment in Patients With Biliary Tract Carcinoma

A phase II, single-arm, open-label, multicenter study to assess the efficacy and safety of Surufatinib as a second-line treatment in patients with surgically unresectable or metastatic biliary tract carcinoma

This study adopt Simon's two-stage designs method based on the primary endpoint of 16-week PFS rates. In the first stage, 16 patients will be recruited. If there are 3 or fewer patients without progression or death out of these 16 patients at week 16, the study will be stopped. Otherwise, 16 additional patients will be accrued for a total of 32 evaluable patients.

Surufatinib will be orally administered within 1 hour after breakfast once a day (QD) for every 28-day treatment cycle until disease progression, death, intolerable toxicity or other protocol specified end-of-treatment criteria is met (which comes first).

Eligibility Criteria:
Inclusion Criteria:

1. Provision of written Informed Consent Form (ICF) prior to any study specific procedures
2. Aged at least 18 years
3. Histologically or cytologically confirmed advanced BTC that was surgically unresectable or metastatic, including extrahepatic cholangiocarcinoma (EHCC), intrahepatic cholangiocarcinoma (IHCC) or gallbladder biliary carcinoma (GBC)
4. First-line prior treatment of cytotoxic chemotherapy, treatment failure or intolerable toxicities
5. ECOG 0-1
6. Patients must have measurable lesions

Exclusion Criteria:

1. Anti-tumor therapy received within 4 weeks prior to initiation of study treatment
2. Previous therapy with approved or investigational anti-VEGF (or VEGFR) tyrosine kinase inhibitors or monoclonal antibody
3. Liver metastases ≥50% of liver volume
4. Child-Pugh classification score of liver function\> 7
5. History or presence of a serious hemorrhage (\>30 ml within 3 months), hemoptysis (\>5 ml blood within 4 weeks) or a thromboembolic event (including transient ischemic attack and/or stroke events) within 12 months
6. Active malignancy (except for definitively treated basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix) within the past 5 years
7. Patients receive CYP3A4 potent inducer or inhibitors within 2 weeks
8. Pregnancy ( positive pregnancy test before the first dose of study treatment) or lactating women
Leucine Supplementation and Skeletal Muscle Disuse

Leucine supplementation is widely known for promoting strong influence on skeletal muscle remodeling. This study aims to evaluate the effect of leucine supplementation on disuse-induced skeletal muscle atrophy.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of anterior cruciate ligament injury
* Physically active
* Must be able to swallow tablets
* Non-smokers
* Do not use nutritional supplements

Exclusion Criteria:

* Post-surgical complications
Impairment of the Cognitive Flow in the Development of a Depressive Disorder and Suicidal Ideas

The study consists in estimating the mental load (cognitive saturation) and the production of driving cognition to suicidal patients.

The study consists in testing two big general hypotheses:

* In the first place, that suicidals presents a mental load (cognitive saturation) and an activity pain behaviour of their space of the thought by extremely painful peripheral cognitive movements (impression that the brain is saturated of thoughts, turbulences, internal movements)
* Secondly, that suicidals produces a surplus of representations of action, such takes out that their vision of the world is saturated of a not integrable kinaesthetic imaging by the subject.

Eligibility Criteria:
Inclusion Criteria:

* Patients followed within the framework of an ambulatory follow-up post-emergencies(post-urgent matters).
* Knowledge of the French language
* patient who have signed of the form of consent,
* patient presenting one anxio-depressive disorder(confusion) with or without suicidal episode.

Exclusion Criteria:

* Not compatible health with the signing of the protocol,
* the not knowledge of the French language,
* patient who have refused the protocol.
Liver Cancer HepaSphere Combined With Cryosurgery

The purpose of this study is to evaluate the safety and efficacy of HepaSphere interventional therapy using digital subtraction angiography（DSA）combined with cryosurgery for liver cancer.

By enrolling patients with liver cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of HepaSphere interventional therapy using digital subtraction angiography（DSA） combined with cryosurgery for liver cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Age:18-80
2. Karnofsky performance status \>60
3. Diagnosis of pancreatic cancer based on histology or the current accepted radiological measures.
4. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
5. Will receive interventional therapy
6. Life expectancy: Greater than 3 months
7. Patients' routine blood test, liver function and kidney function have no obvious abnormalities
8. Ability to understand the study protocol and a willingness to sign a written informed consent document

Exclusion Criteria:

1. Patients with other primary tumor except liver cancer
2. History of coagulation disorders or anemia
A Study of V330 in Healthy Younger (18 to 49 Years Inclusive) and Healthy Older (60 to 79 Years Inclusive) Participants (V330-001)

The goal of this study is to learn whether a new vaccine, V330, is safe and learn how well the body's immune system responds by making antibodies after receiving V330.


Eligibility Criteria:
Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

* Is in good health prior to randomization
* Is an individual from 18 to 49 years of age inclusive or from 60 to 79 years of age inclusive

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

* Has a history of myocarditis, pericarditis, and/or myopericarditis
* Has a history of cancer
Long Duration Holter ECG in Fabry Disease

The main objective is to assess the occurrence of cardiac arrhythmias and conduction disorders during a three-year follow-up using implantable Holter ECG monitoring in 40 patients with Fabry disease. The secondary objectives are to analyze the correlations of these anomalies with changes in cardiac MRI and echocardiographic parameters as biological parameters and overall severity of the disease assessed by MSSI.

The main objective of this non-blinded, monocentric non-randomized study is to assess the occurrence of cardiac arrhythmias and conduction disorders (sinus dysfunction, branch block \[BB\], atrioventricular block \[BAV\], sustained \[TVS\] or non-supported \[TVNS\] ventricular tachycardias, atrial fibrillation \[AF\] during a three-year follow-up in 40 patients with Fabry disease (half with left ventricular hypertrophy) using an implantable Holter ECG device (Medtronic Reveal-LINQ™). The secondary objectives are to analyze the correlations (at 1, 2 and 3 years) of these anomalies with the modifications of :

* cardiac MRI \[Magnetic Resonance Imaging\] data at inclusion \[M0\] and at 36 months \[M36\] (left ventricular hypertrophy \[HVG\], amplitude of the T1 signal, extent of fibrosis); MRIs will be performed before implantation and after removal of the Holter to avoid the reading artifacts linked to the device.
* echocardiographic measurements of the left ventricle (overall longitudinal strain systolic \[SGL\] and ejection fraction \[FE\])
* biological parameters (BNP or NT-proBNP, ultra-sensitive troponin and Lyso-Gb3)
* the overall severity of the disease assessed by MSSI (Mainz Severity Score Index), DFG and proteinuria

Eligibility Criteria:
Inclusion Criteria:

* Male patient
* Age greater than or equal to 18 years on the day of inclusion
* Presence of a morbid mutation for MF
* Signature of the informed consent form
* Absence of significant valve disease, verified on medical file (absence stenosis or regurgitation \<2+ in color Doppler on a scale 1 to 4+ by extension of the jet)
* No history of known or documented myocardial infarction nor CAD
* No pacemaker or ICD
* no history of AF, NSVT, high-degree AV block
* Correct echogenicity
* No treatment by corticosteroid or immunosuppressive drugs
* creatinine clearance \>/= 30 Ml/mn
* LVEF ≥ 50% by ultrasound and / or MRI
* No contraindication to MRI (or claustrophobia) and gadolinium injection
* Affiliation to the French social security insurance
Clinical Study to Establish the Feasibility and Usability of the EndoRings™

The purpose of this prospective clinical study is to establish the feasibility and usability of the ENDORINGS™ when used during standard colonoscopy procedure.

The EndoAid Ltd. EndoRings is used during endoscopy procedures. The EndoRings is a short silicon rubber tube with flexible circular wings that attaches to the distal end of the endoscope to facilitate endoscopic therapy.

The EndoRings is designed to fit specific endoscopes (as designated on the packaging), and is supplied sterile following ETO sterilization and is single use only.

Indications for Use:

To be attached to the distal end of the endoscope to facilitate endoscopic therapy, to be used for the following:

* Keeping the suitable depth of endoscope's view field
* Helping the endoscope with being inserted into the gastrointestinal tract

Patient Population: The study population is comprised of patients indicated for colonoscopy.

Study Design: Single-center study. A single treatment group of 60 patients. No. of Patients: Up to sixty (60) treated patients will be enrolled in the study.

Primary Endpoints:The primary endpoint is reaching the cecum of the colon with the ENDORINGS™.

Secondary Endpoints / Other Outcomes:

1. Incidence of complications (number of complications)
2. Ability to complete s therapeutic interventions as biopsies, polypectomies, APC etc.
3. Procedure time.
4. Ease of scope insertion, advancement and withdrawal.
5. Ability to center the scope inside the gastrointestinal tract.
6. Subjective evaluation of the additional area screened by the physician (recorded in the source documents by a questionnaire).
7. Patient satisfactory (by a follow up phone-call in which questionnaire with VAS scale will be filled out).

Eligibility Criteria:
Inclusion Criteria:

Any subject who meets all of the following criteria may be included in this study:

* Subject between the ages of 18 and 70
* The patient is undergoing colonoscopy for screening, or for surveillance in follow-up of previous polypectomy or for diagnostic workup;
* Written informed consent must be available before enrollment in the trial
* For women with childbearing potential, adequate contraception

Exclusion Criteria:

Any subject who meets any of the following criteria will not be included in this study:

* Patients with a history of colonic resection;
* Patients with inflammatory bowel disease;
* Patients with a personal history of polyposis syndrome;
* Patients with suspected chronic stricture potentially precluding complete colonoscopy;
* Patients with diverticulitis or toxic megacolon;
* Patients with a history of radiation therapy to abdomen or pelvis;
* Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.
Immunogenicity and Safety Study of a GlaxoSmithKline Biologicals' Candidate Influenza Vaccine in Healthy Children

The purpose of the present study is to assess the immunogenicity and safety of vaccine GSK2321138A in children.


Eligibility Criteria:
Inclusion Criteria:

For all subjects:

* Subjects who the investigator believes that they and/or their Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
* Written informed consent obtained from the subject/from the LAR(s).

For unprimed subjects:

* A male or female child aged 18 to 47 months at the time of the first vaccination.
* Children who did not have influenza vaccine in a previous season.

For primed subjects from study NCT00764790:

• Children who received Fluarix™ in the 111751 study NCT00764790.

Exclusion Criteria:

* Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* History of hypersensitivity to any vaccine.
* History of allergy or reactions likely to be exacerbated by any component of the vaccine.
* Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before and ending 28 days after each dose of vaccine(s).
* Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
* Acute disease at the time of enrolment.
* History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
* Receipt of another seasonal influenza vaccine outside of this study, during current (2009-2010) flu season.
* Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccination Inhaled and topical steroids are allowed.
* Administration of immunoglobulins and/or blood products within the 3 month preceding the first dose of study vaccine or planned administration during the study period.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
Pharmacogenomics of Antithrombotic Drugs -a Register Linkage Study With National Registries and Biobanks in Finland

This is a retrospective cohort study linking data from Finnish Biobanks (Helsinki Biobank, Auria Biobank and THL Biobank), laboratory databases, and national registries of Social Insurance Institution of Finland (Kela) and the National Institute of Health and Welfare (THL) to investigate pharmacogenomics of antithrombotic drugs in the Finnish population. The purpose of the study is to assess clinical and economic aspects of using genomic data in the context of antithrombotic drug therapy.

Based on earlier research, data regarding variant alleles in CYP2C9 and VKORC1 will be used in the primary analyses. Individuals with and without specific variant alleles are compared in respect to their clinical response to warfarin therapy. Warfarin-treated individuals are also analysed in relation to other clinical outcomes and a wide range of healthcare encounters.

The explorative part of the study will employ data-driven classification methods to explore genotype-phenotype associations for a larger group of antithrombotic drugs including direct oral anticoagulants, clopidogrel and heparins and possible interactions with other drugs. In this part, 26 gene variants identified in literature will be used.

The retrospective follow-up time for the study participants is from January 2007 to December 2018, or 2 years prior the first anticoagulant drug is purchased until 6 months after the last purchase.


Eligibility Criteria:
Inclusion Criteria:

* Genotyped for CYP2C9/rs1799853, CYP2C9/rs1057910 and VKORC1/rs9923231
* Diagnosed with at least one of the following:

  * Atrial Fibrillation and Flutter (I48)
  * Ischemic Heart Disease (I20-I25)
  * Cerebrovascular disease (I63,I65,I66, 167.2, I69.3-I69.8)
  * Atherosclerosis (I70)
  * Pulmonary embolism (I26)
  * Phlebitis and thrombophlebitis (I80)
  * Portal vein thrombosis (I81)
  * Other venous embolism and thrombosis (I82)
* Purchased at least one of the following drugs between January 1st 2007 - December 31st 2018:

  * Anticoagulants: Warfarin, Dabigatran, Apixaban, Rivaroxaban, Edoxaban, Heparin, Enoxaparin, Dalteparin
  * Antiplatelets: Clopidogrel, Ticagrelor, Acetylsalicylic acid

Exclusion Criteria:

* Permanent residence in Finland less than 12 months during the follow-up period
* Purchase of any of the antithrombotic drugs listed above between January 1st 2005 - December 31st 2006
POISE I Pilot Study

POISE I study is a feasibility study for evaluating the safety and efficacy of DCB.

The study is designed to determine the safety and effectiveness for drug coated balloon (DCB) for treating intestinal strictures.

Up to 15 subjects are planned to be enrolled and treated with the study device at up to 5 clinical sites outside of US. Subjects will be followed up post-treatment to one year and then annually for up to 5 years. The annual follow up after the first year is optional.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 and ≤ 80 years.
2. Subjects for whom the balloon dilation would be chosen in standard practice, and the scope could not pass stricture.
3. Recurrent to plain balloon dilation with at least 2 previous balloon dilation or stricturotomy sessions and recurrence of intestine obstructive symptoms/signs.
4. Symptoms of intestinal partial occlusion
5. Length of stenosis/stricture ≤ 7 cm
6. Up to 2 discrete strictures.
7. Ability to undergo periodic endoscopic follow-up.
8. Voluntary participation and provided written informed consent.

Exclusion Criteria:

1. Pregnancy or breastfeeding or plan to get pregnant in next 12 months.
2. Contraindication to endoscopy, anesthesia or deep sedation.
3. Malignant bowel stricture.
4. Extrinsic benign bowel stricture due to adhesion.
5. Stricture complicated with abscess, fistula, ulceration or associated with mesenteric vessel thrombosis
6. More than 2 stenosis/stricture lesions.
7. Length of stenosis/stricture \> 7 cm.
8. Stricture not accessible by endoscopy.
9. Suspected perforation of the gastrointestinal tract
10. Acute bowel obstruction requiring urgent surgical intervention
11. Low rectal or anal strictures
12. Severe coagulation disorders (platelets \< 70000; INR \> 1.8).
13. Active systemic infection
14. Allergy to paclitaxel or any components of the delivery system.
15. Life expectancy of less than 12 months.
16. Drug abuse or on chronic steroid therapy for comorbidities.
17. Unwilling or unable to comply with the follow-up study requirements.
18. Lacking capacity to provide informed consent.
19. Concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety.
20. Currently participation in another pre-market drug or medical device clinical study.
21. Chronic steroid use for any medical conditions unless subject is willing to undergo a 4-week washout and discontinue steroid use.
22. Currently requiring abdominal radiation therapy
Citicoline as Neuroprotector in Preterm

Citicoline as neuroprotector in preterm

Efficacy of Citicoline as neuroprotector in preterm; A randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Preterm on CPAP or ventilator

Exclusion Criteria:

* Multiple congenital anomalies