cyrilzakka/clinical-trials huggingface dataset:
COOL-Trial: Outcome With Invasive and Non-invasive Cooling After Cardiac Arrest

Sudden cardiac arrest (SCA) remains one of the major leading causes of death. Cognitive deficits are common in survivors of SCA. Postresuscitative mild induced hypothermia (MIH) lowers mortality and reduces neurologic damage after cardiac arrest. The investigators evaluated the efficacy and side effects of therapeutic hypothermia in an unselected group of patients after SCA.

Consecutive patients with restoration of spontaneous circulation (ROSC) after resuscitation due to out-of-hospital SCA, admitted to our intensive care unit, underwent MIH. Hypothermia was induced by infusion of cold saline and whole-body-cooling methods (electronic randomization: invasive Coolgard or non-invasive ArcticSun). The core body temperature was operated at 32 to 34 °C over a period of 24 hours followed by active rewarming. Neurological status was evaluated at hospital discharge and 6 months after discharge using the Pittsburgh Cerebral Performance Category (CPC). Blood samples of neuron-specific enolase (NSE) were collected during 72 hours.

Eligibility Criteria:
Inclusion Criteria:

* ROSC after SCA due to VF/VT or PEA/Asystolia
* GCS 3

Exclusion Criteria:

* Non-cardiac SCA
* Pregnancy
* Unstable Circulation instead of High-dose Inotropics
* Life-expectancy reducing concomitant illness
Efficacy and Safety of Early Supported Discharge for Post-Acute Stroke Patients in Korea

The study aims to examine the effect of early supported discharge (ESD) service on the functional outcomes and quality of life of acute stroke patients with mild to moderate disability in Korea.

The study is a double-armed prospective multi-centered, assessor-blinded randomized controlled trial comparing the effect of ESD program with conventional rehabilitation program.

Early Supported Discharge (ESD) is a form of medical service applicable to acute stroke patients with mild to moderate disabilities. ESD service was developed to facilitate patient to their daily livings at home, reduce the length of stay in the hospital with possibly better or equivalent outcomes for patients and caregivers.

ESD service has been proven to be non-inferior in the functional and quality of life measures as well as cost-effective, compared to the conventional rehabilitation service in many countries, however the effectiveness of ESD service may differ among countries and medical, economical circumstances. This study aims to examine the effect of ESD service on the acute stroke patients with mild to moderate disabilities in Korea and demonstrate its feasibility as an alternative medical service option to those patients.

Eligibility Criteria:
Inclusion Criteria:

* Patient who is over 20 years old
* Patient who had acute stroke and admitted to hospital (excludes TIA)
* Patient who will be discharged to home within 30 days after onset
* Patient who has indwelling caregiver and is able to support in ESD program
* Patient who's initial mRS is 1-3
* Patient who's initial FAC is 3 or above
* Patient who's initial K-NIHSS consciousness scores (1a,1b,1c) are all 0

Exclusion Criteria:

* Patient who had Transient Ischemic Attack
* Patient who is medically unstable requiring intense treatment
* Patient who has indwelling urinary catheter
* Patient who is unable to intake food by mouth
* Patient who is initial MMSE is below 15
* Patient who has uncontrolled pain
* Patient who has psychobehavioral problems
Comparison of Two Electroencephalograms (EEG) Monitors in Patients Undergoing General Intravenous Anesthesia

Quantium Medical Company has an ElectroEncephalograph-based (EEG-based) algorithm with two outputs: qCON for unconsciousness and qNOX for anti-nociception. qCON, is designed to provide information about the depth of the hypnotic state, similar to that provided by the BIS™.


Eligibility Criteria:
Inclusion Criteria:

* Patients above 18 years,
* Patients affiliated to a national insurance scheme or benefiting from such a program,
* Patients having given their written consent,
* Patients that must benefit from a general anesthesia by intravenous drugs (propofol and remifentanil),
* For the patients taken care in ambulatory surgery, having a telephone and agreeing to communicate their phone number.

Exclusion Criteria:

* Pregnant or breast-feeding Women,
* Patients having a limit of use of the Bispectral Index (BIS) or qCON monitors,
* Patients having a contraindication to Propofol and/or to Remifentanil.
Determining the Amount of Time Needed for Nelfinavir to Boost the Immune System in Adults

Our group has shown that HAART increases the thymic production of naïve T cells in the healthy adult, thereby boosting the immune system. We propose to investigate the amount of and length of Nelfinavir therapy necessary to increase those cells in adults. Subjects will be treated with Nelfinavir, and blood will be sampled at variable times to determine the immune response in peripheral blood.

Blood will be collected at several time points during the study. DNA will be isolated from peripheral blood lymphocytes (PBL) and assessed for signal point (sj) TREC content relative to genomic CCR5 copies by real time PCR in a spectoflourometic thermal cycler. TREC values will be expressed as TREC copy number per copies of CCR5 or TREC/PBLs.

We anticipate that we will confirm our previous observations that nelfinavir therapy will increase TRECs, indicating naive T cell production from the thymus. The proposed study will determine the time course of the anticipated increase in TREC/PBLs.

Eligibility Criteria:
Healthy individuals between the ages of 20 and 100. Exclusion criteria include the following: HIV, HBV/HCV positive, known sensitivity to protease inhibitors, oral intake contraindicated, diabetes mellitus diagnosed within the last six months, and any of the following medications: cisapride, amiodarone, terfenadine, rifampin/rifabutin, phenobarbital, pinozide, St. John's wort, ergot derivatives, quinidine, astemazole, carbemazapine, phenytoin, midazolam, triazolam, and simvastatin.
Antithrombotics and Complications in Skin Grafts

Patients who were referred to cutaneous surgery and needed full thickness or split skin grafting and using antitrombotic or non-antitrombotic therapies were observed. Data on patient characteristics, diagnosis, location of surgery and surgery performed, antithrombotic medication and complications in skin grafts were collected. Skin grafts were traced on a transparent film and areas of unhealed skin graft were marked

Use of anticoagulants is common and practice regarding continuation or discontinuation of the medication peri-operatively for cutaneous surgery lacks evidence-based consensus. Therefore, patients who were referred to cutaneous surgery and needed full thickness or split skin grafting and using antitrombotic or non-antitrombotic therapies were observed. Data on patient characteristics, diagnosis, location of surgery and surgery performed, antithrombotic medication and complications in skin grafts were collected. Skin grafts were traced on a transparent film and areas of unhealed skin graft were marked

Eligibility Criteria:
Inclusion Criteria:

Patients referred to cutanous surgery with full thickness or split skin grafting. The excision should be performed on the levels of subcutis or perichondrium -

Exclusion Criteria:

Patients having a pacemaker, needed skin graft on bare bone and patients with an INR above 3.5

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Bioequivalence Study of Montelukast 5 mg Chewable

The objective of this study was to confirm if two formulations of montelukast tablets are bioequivalent.

Test product was Montelukast (5 mg chewable tablets; GlaxoSmithKline) and reference product Singulair (5 mg chewable tablets; Merck Sharp \& Dohme). The single dosage was one tablet.

The study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions.

The population was composed of 32 healthy volunteers, both genders, adults between 18-50 years.

The comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.


Eligibility Criteria:
Inclusion Criteria:

Free will participation according to Mexican regulation, Helsinki Declaration, and Good Clinical Practice.

Healthy, between 18 and 50 years. Body Mass Index between 19 and 27 In good health by complete medical history and laboratory tests. Blood pressure 130-90/ 90-60 mm Hg; heart rate 55-100 beat per minute, respiratory rate 14-20 movements per minute.

Laboratory tests +/- 10% of normal interval (blood cytology, blood chemistry 27 elements, Hepatitis B and C antigens, HIV, urinalysis, anti-doping, pregnancy, electrocardiogram) -

Exclusion Criteria:

Alteration of vital signs Not complying with inclusion criteria History of cardiovascular, kidney, hepatic, muscular, metabolic, gastrointestinal (including constipation), neurologic, endocrine, hematopoietic (any kind of anemia), asthma, mental or organic disease. Those suffering from muscular trauma 21 days before the beginning of the study.

Requirement of any kind of medication during the course of the study, except study medication.

History of dyspepsia, gastritis, esophagitis, duodenal or gastric ulcer. Exposure to medications known as inducers or inhibitors of hepatic enzymes or administration of potentially toxic medication in the 30 days before the study beginning.

Administration of any medication in the 14 days or 5 half-lives (whatever longer) previous to the beginning of the study.

Hospitalization for any cause in the seven months before the beginning of the study.

Administration of investigational drugs in the 60 days before the study. Allergy to any antibiotic or non-steroidal anti-inflammatory analgesic. Alcohol ingestion or intake of beverages containing xanthines (coffee, tea, cocoa, chocolate, mate, cola drinks) or ingestion of charcoal grilled food or grapefruit or orange juice in the 72 hours before the hospitalization or tobacco smoking in the 72 hours before the beginning of the study.

Blood donation or loss =\> 450 ml in the 60 days before the beginning of the study.

History of drug or alcohol abuse. Positive pregnancy test. Special diet requirement, for instance vegetarian diet. Inability to understand nature, aims, and possible consequences of the study. Evidence of non-cooperative attitude during the study. Breast-feeding. Females on contraceptive hormonal treatment.

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Evaluation of Postoperative Pain and Bacterial Load Reduction With ProTaper Ultimate Versus ProTaper Gold Rotary Systems

This study aims to research the effect of different instrument designs by comparing protaper ultimate versus protaper gold systems on root canal preparation by evaluating bacterial count reduction and post-operative pain following single visit treatment in patients with necrotic pulp in maxillary premolar teeth.


Eligibility Criteria:
Inclusion Criteria:

* Patient's age ranges between 22 to 45 years with no sex predilection.
* Medically free patients.
* Maxillary permanent premolar teeth:

  * Diagnosed clinically with pulp necrosis.
  * Absence of pain.
  * Radiographic evidence of two roots or single root with double canals.
  * Slight widening in the periodontal membrane space or with peri-apical radiolucency
  * No response to cold pulp tester and ethyl chloride spray.
* Patients who can understand Modified Visual Analogue Scale (VAS).
* Patients' acceptance to participate in the trial.

Exclusion Criteria:

* Medically compromised patients.
* Pregnant women.
* If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively.
* Patients reporting bruxism or clenching.
* Teeth with:

  i. Vital teeth. ii. Single canal maxillary premolar teeth iii. Association with swelling or fistulous tract. iv. Acute peri-apical abscess and swelling. v. Mobility Grade II or III. vi. Pocket depth more than 5mm. vii. Previous root canal therapy. viii. Non-restorable teeth: Hopeless tooth
* Immature teeth.
* Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification, root caries.
Evaluation of the Safety and Effectiveness of Direct-acting Antiviral Drugs in the Treatment of Hepatitis C in Patients With Inflammatory Bowel Disease: National Multicenter Study

The prevalence of hepatitis C virus infection (HCV) in patients with inflammatory bowel disease (IBD) ranges from 1-6%. Direct-acting antivirals (DAAs), with cure rates \>90%, represent a radical change from interferon-based therapies. The ECCO (European Crohn's and Colitis Organisation) guidelines (Kucharzik T, Ellul P, Greuter T, et al. ECCO Guidelines on the Prevention, Diagnosis, and Management of Infections in Inflammatory Bowel Disease. J Crohn's Colitis. 2021;15(6):879-913) warns about the risk of IBD reactivation due to the effect of DAAs, but HCV management in this situation is uncertain given the lack of evidence.

The project is proposed as the largest retrospective multicenter descriptive study carried out to evaluate the use of DAAs for HCV eradication in patients with IBD. The Eneida database (Zabana Y, Panés J, Nos P, et al. The ENEIDA registry (Nationwide study on genetic and environmental determinants of inflammatory bowel disease) by GETECCU: Design, monitoring, and functions. Gastroenterol y Hepatol. 2020;43(9):551-8.) of the Spanish Working Group on Crohn's Disease and Ulcerative Colitis (GETECCU) is an adequate registry to identify patients with HCV infection. The serological status of the infection is frequently recorded in the ENEIDA database, and it is generally evaluated at the time of IBD diagnosis, before starting immunosuppressive treatment. The ENEIDA registry has the advantage over large population studies that researchers have access to relevant details of the clinical history, which can respond to the controversies raised.

This multicenter retrospective descriptive study will provide useful information to be able to give evidence-based recommendations regarding treatment of HCV in patients with IBD.

Hypothesis:

The use of DAAs for HCV eradication in patients with IBD is effective and safe. DAAs do not trigger IBD flares. DAAs probably do not present serious pharmacological interactions, with clinically relevant, with immunosuppressants and/or biological agents.

Eligibility Criteria:
Inclusion Criteria:

* All individuals diagnosed with IBD according to the ECCO criteria and chronic HCV infection (positive HCV Ab and detectable RNA) treated with DAAs and/or interferon collected in the ENEIDA database, and who have properly completed the fields of age, gender, treatment, location, and phenotype of IBD, will be included in the study.
* Study period: Patients treated with DAAs between January 1, 2011 - February 28, 2021.

Exclusion Criteria:

* Spontaneous cure of HCV without treatment
* HCV treatment outside the study period.
Ultraviolet Germicidal Irradiation on the New Silicone Half-Piece Elastometric Respirators

Since the innovation of our new half- elastometric half-piece respirator, this type of FFR has been used widely in our country. Decontamination methods including ultraviolet C (UVC) germicidal irradiation and 70% alcohol have been implemented to decontaminate the respirator. We than examined inactivation potential for the Porcine epidemic diarrhea virus (PEDV), numerous bacterial strains ,mostly skin-derived after the decontamination process.To enable rigorous integrity after repeated decontamination process, fit test by the Bitrex test ,tensile strength and elongation at break were also evaluated. Our results showed that the UVC at the dose of 3 J/cm2 can eradicate the bacteria at 60 min and virus at 10 min.No fungus was found on the mask surface at the beginning. Good Fit test , tensile strength and elongation at break were still main maintained after multiple cycles of decontamination. No evidence of physical degradation by gross visual inspection was found. 70% alcohol is also an easy and effective way to eradicate microorganisms on the mask.As the current pandemic is expected to continue for months to years, the need to supply adequate reserves of PPE and develop effective reprocessing is crucial. Our studies demonstrated that the novel silicone mask can be safely reprocessed and decontaminated for many cycles by UVC irradiation and help restore the shortage of the important protective devices in the COVID-19 pandemic era.

this study showed that UVC irradiation at the dosage 300 uWatt-sec/cm2 for 1 minute satisfactorily decontaminated the silicone mask as measured by viral culture. The timing to eradicate bacteria was 60 minutes longer due to the tolerability of the bacteria .70% alcohol effectively decontaminate the virus and bacteria deposited on the masks and filters. Good level of fit can be maintained following UVC treatment. The tensile strength of the strap was retained over multiple decontamination cycles using UVC and dry heat upto 60 cycles.Given the efficacy of the disinfection by UVC and 70 % alcohol ,these types of decontamination method could potentially be used for the new type of silicone masks half-piece respirator in the setting of a crisis with inadequate supplies of PPE.

Eligibility Criteria:
Inclusion Criteria:

Healthy volunteers 18 to 60 years old.

Exclusion Criteria:

* contraindications to fit test, such as asthma, congestive heart failure, anosmia, and ageusia.
Evaluation of Long-term Adverse Effects of Gastric Bypass in Omega

The omega gastric bypass (OAGB) is developing worldwide as an alternative to the Y gastric bypass (RYGB). Cases of nutrition deficiency after OAGB, in particular protein deficency, are regularly reported in the literature, raising the question of the medium/long-term safety of this procedure. In its technology assessment report issued in September 2019 (HAS, 2019), the Haute Autorité de Santé rules on the invalidity of OAGB with a 200 cm biliary limb and the lack of sufficient data on the safety of OAGB with a 150 cm biliary limb compared to RYGB. The lack of long-term data on weight, resolution of comorbidities, quality of life, and endoscopic evaluation given the risk of lower esophageal cancer is also noted.

The main objective of the study is to compare the incidence of serious adverse events related to surgery after OAGB at 10 years, according to 2 types of loop: a realization with a 150-cm biliary loop (OAGB AB150) versus a realization with a 200-cm biliary loop (OAGB AB200).


Eligibility Criteria:
Inclusion Criteria:

* Patients who received 10 ± 2 years ago (between 2009 and 2013) an OAGB with a 150 or 200cm biliary limb. Patients should be consecutive at each center.
* Patients fulfilling the criteria of indication for bariatric surgery at the time of their intervention according to the recommendations of the HAS (HAS, 2009) in an expert center.
* Patients agreeing to perform an endoscopic evaluation with biopsies at 10 years
* Patients who gave their consent
* Patients with health insurance coverage

Exclusion Criteria:

* Contraindication to bariatric surgery defined according to HAS recommendations (HAS, 2009)
* Persons deprived of liberty, under guardianship, or under curatorship
* Patients included in a protocol with a conflict of interest with OMEGA10.
Internet Telehealth for Pediatric Asthma Case Management

The original and primary aim of this study is to evaluate the effects of CHESS with Nurse Case Management on asthma control (symptom-free days), and adherence factors of children aged 4-12. The investigators have expanded the scope of the specific aims. The criteria for their expanded aim is to also interview low-income African-American caregivers to gain an understanding of how they conceptualize their child's asthma, and what they consider to be barriers or facilitators to managing their child's asthma. There is no change in the investigators' original aim.


Eligibility Criteria:
Inclusion Criteria:

* Parents of children, aged 4-12 with moderate to severe asthma
Reinforcing Therapist Performance

The specific aims of the proposed study are to evaluate the effectiveness and cost-effectiveness of providing monetary incentives to therapists as a method to improve implementation of evidence-based treatments.


Eligibility Criteria:
Inclusion Criteria:

* Must work at one of the participating demonstration sites funded by the Center for Substance Abuse Treatment to deliver the Adolescent Community Reinforcement Approach and/or Assertive Continuing Care.
Assessment of Septin9 Biomarker for Detection of Colorectal Cancer in Patients With Positive Fecal Immunochemical Test

Colorectal cancer (CRC) is the second leading cause of cancer death in the United States and affects men and women almost equally. The United States Preventative Services Task Force (USPSTF) currently recommends screening with any of three options, which include fecal testing, flexible sigmoidoscopy, or colonoscopy.

Screening for CRC with fecal occult blood testing (using a guaiac-based test) done annually or biennially has been shown to decrease mortality 15-33% primarily through detection of early stage cancer. Guaiac fecal occult blood testing (gFOBT) has a known positive balance of benefit and risk in screening populations, is the least expensive, and is the preferred method of screening in 30-55% of patients. The fecal immunochemical test (FIT) offers significant improvements over the gFOBT, most notably that it is easier to use (requires fewer samples and no dietary or medication restrictions) and is more sensitive than the gFOBT with respect to detecting both CRC and precancerous adenomas. As a result of improved test performance and usability, in 2008 multiple professional societies endorsed the use of four types of FITs for colorectal cancer screening. Kaiser Permanente currently uses the OC-Micro FIT as the fecal screening test in all regions.

In recent years, intensive efforts have been undertaken to identify blood-based markers that may provide a promising alternative or supplement to fecal testing for non-invasive CRC screening. One method under development is to identify aberrantly methylated genes in cancer tissue through a blood test. Prior studies have explored those specific colorectal cancer genes that show the highest differences in methylation between the cancer and background genetic expression. Of these, methylation of the Septin 9 gene through a qPCR assay is relatively well studied.

The proposed study aims to evaluate whether the Septin 9 biomarker may be used to supplement the OC-Micro FIT for colorectal cancer screening in such a way as to safely reduce unneeded colonoscopies. The population of interest for this study-those with a positive screening OC-Micro fecal immunochemical test-has a CRC prevalence of approximately 5%. Knowing how well Septin 9 can identify those without cancer prior to colonoscopy is important largely because colonoscopy, even when done diagnostically (e.g., after a positive FIT result), can cause serious complications.


Eligibility Criteria:
Inclusion Criteria:

* Aged 49-80
* Member of Kaiser Permanente Northwest or Southeast
* English or Spanish speaking
* Had a positive fecal screening (FIT) and has an active referral to colonoscopy

Exclusion Criteria:

* Having a personal history of colon cancer
* Having had a prior colonoscopy within 5 years
* Currently under hospice care
* Currently in a skilled nursing facility
* Currently being treated for active cancer (any type)
* Having ever had carcinoid tumor or full colectomy
* Having indicated a preference at enrollment into Kaiser health plan to not participate in research