bioihbjkbjnl/mcl2 huggingface dataset:
Assessment of Duodenal Epithelial Integrity in Celiac Disease With Mucosal Impedance
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Observational

Summary: 
      Increased intestinal permeability can represent compromise of the epithelium's integrity and
      is thought to be the primary mechanism in patients who develop Celiac Disease (CeD) and
      non-celiac gluten sensitivity when gluten peptides cross the barrier and trigger an immune
      response. In this study, the investigators propose to use a novel, minimally invasive
      technology to detect mucosal damage (i.e. barrier dysfunction) in the duodenal epithelium.
      The primary aim of this study is to identify if there is a difference in duodenal mucosal
      impedance between CeD and control patients.
    


Intervention name(s): Mucosal Impedance Catheter; Blood sample
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): During routine endoscopy, consented study participants will have a mucosal impedance catheter sensor positioned along the mucosal wall to measure resistance across the mucosa. The study procedure will add approximately 1-2 minutes of anesthesia time for each participant.; At time of endoscopy, subjects with initial positive CeD serology will have a blood sample taken for any missing CeD serologies and intestinal fatty acid-binding protein (IFABP). This will be done at time of IV initiation as to avoid any additional venipuncture.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Celiac disease patients will be identified in the Celiac Disease Clinic at Vanderbilt.
        Patients will be asked if they would like to participate in the study during their clinic
        visit and will undergo consent for the study at the time of procedure. Control subjects
        will be asked about participation at the time of routine endoscopy.
Aprepitant in the Management of Biological Therapies-related Severe Pruritus
Condition: ITCH
MeSH terms: Pruritus
Study type: Interventional
Phase: Phase 2

Summary: 
      Itch is a common side effect of anti-epidermal growth factor receptor antibodies and tyrosine
      kinase inhibitors. Investigators designed a pilot single-center phase II study evaluating the
      effects of Aprepitant, a neurokinin receptor inhibitor, in managing biological
      therapy-induced pruritus.
    

Detailed description: 
      Investigators enroll patients affected by solid tumors which present itch refractory to
      standard treatment ("refractory group") and patients who did not receive any treatment for
      pruritus ("naïve group"). The intensity of itch will be evaluated with Visual Analogue Scale
      (VAS) score. In the refractory group Aprepitant (125 mg on day 1; 80 mg on day 3; 80 mg on
      day 5) will be administered after at least 1 week of standard systemic treatment. In the
      naïve group, Aprepitant will be administered after the first onset of severe pruritus. The
      primary end point is to evaluate the effect of aprepitant in managing pruritus both in naive
      and refractory group.
    

Intervention name(s): Aprepitant; Prednisone; Fexofenadine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 125 mg on day 1; 80 mg on day 3; 80 mg on day 5; In the refractory group (VAS score ≥7), Aprepitant (125 mg on day 1; 80 mg on day 3; 80 mg on day 5) is administered after at least one week of standard systemic treatment (prednisone 25 mg/die and/or fexofenadine 180 mg/die),; In the refractory group (VAS score ≥7), Aprepitant (125 mg on day 1; 80 mg on day 3; 80 mg on day 5) is administered after at least one week of standard systemic treatment (prednisone 25 mg/die and/or fexofenadine 180 mg/die)
Other intervention name(s): Emend
Intervention MeSH terms: Fexofenadine; Prednisone; Aprepitant
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: ITCH
Biomarkers of Response to Ketamine in Depression: MRI and Blood Assays Before and After Open Label Intranasal Ketamine
Condition: Depressive Disorder, Treatment-Resistant
MeSH terms: Depressive Disorder; Depressive Disorder, Treatment-Resistant
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This pilot study aims to identify predictors of response to intranasal ketamine treatment in
      patients with treatment-resistant depression. Participants will give a sample of blood and
      undergo magnetic resonance imaging before and after a single intranasal ketamine treatment.
      Participants will subsequently receive a second intranasal ketamine treatment.
    


Intervention name(s): Ketamine Hydrochloride
Intervention type(s): Drug
Intervention description(s): Intranasal administration of 40mg ketamine hydrochloride using an intranasal mucosal atomization device
Intervention MeSH terms: Ketamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
L Reuteri for the Prevention of Nosocomial Diarrhea
Condition: Nosocomial Infection; Diarrhea; Gastroenteritis
MeSH terms: Cross Infection; Gastroenteritis; Diarrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      Nosocomial diarrhea is any diarrhea that a patient contracts in a health-care institution. In
      children, it is commonly caused by enteric pathogens, especially rotavirus. The reported
      incidence ranges from 4.5 to 22.6 episodes per 100 admissions. Nosocomial diarrhea may
      prolong the hospital stay and increase medical costs. One of the potential strategies for the
      prevention of nosocomial infections is the use of probiotics. The number of studies have
      shown the efficacy of Lactobacillus reuteri (DSM 17938) in the treatment of acute diarrhea.
      However, there are no data on the efficacy of L. reuteri in the prevention of nosocomial
      diarrhea. The investigators, therefore, plan to perform the study with the aim of evaluating
      the role of Lactobacillus reuteri DSM 17938 administration in the prevention of nosocomial
      gastroenteritis in a pediatric hospital setting.
    

Detailed description: 
      Infants will be randomly assigned at admission to receive L. reuteri in dose of 10(8) CFU in
      5 drops of oil suspension or a comparable placebo once daily for the entire duration of their
      hospital stay.

      Patients will be evaluated daily for stool number and consistency. In case of loose or watery
      stools occurring within 3 days after discharge, patients will be advised to contact hospital
      physicians. Stool samples obtained weekly and during an episode of diarrhea, will be analyzed
      for bacteria with standard stool cultures and rotavirus and adenovirus antigen.
    

Intervention name(s): Lactobacillus reuteri (DSM 17938)
Intervention type(s): Dietary Supplement
Intervention description(s): 5 drops once daily (10(8) CFU) for the entire duration of hospital stay
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: nosocomial infection; diarrhea; Lactobacillus reuteri; gastroenteritis; rotavirus
Paracetamol and Pharmacogenetic
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Recent works has emphasized that the mechanism of action of paracetamol analgesic depend on
      its metabolism in the body, since a breakdown product of paracetamol, the AM404 is now
      considered the analgesic metabolite of paracetamol suggesting as paracetamol may be a
      pro-drug.

      Indeed, it has been shown that paracetamol may have a deleterious effect, especially in
      vulnerable populations (hepatic insufficiency, elderly). First results showed a very
      significant decrease in sulfatation and gluthatione and increased phase 1 metabolism of
      acetaminophen, which involves enzymes such as cytochrome P450.

      Multifactorial causes, combining nutrition (depletion of sulfur amino acids), increased
      detoxification of toxic metabolites of paracetamol, stress or trauma are discussed to explain
      the results.

      Clinical studies showed a great variability of pain assessment by patients and variability in
      the metabolic response of paracetamol. Genetic factors probably play a role remains largely
      unknown.

      The review of the literature on genetic polymorphism shows the involvement of a number of
      enzymes that are well known, predominantly on the metabolism of acetaminophen liver, but
      without connection with its analgesic effect. This is a critical missing link in the
      understanding of the analgesic effect of paracetamol.
    

Detailed description: 
      Randomized, single-center, placebo-controlled, double-blind, cross-over in 100 healthy
      volunteers meeting the inclusion criteria and receiving 2g of paracetamol orally or placebo
      on two study periods separated by one week.

      The evaluation criterion is the difference in areas under the curve of pain thresholds to
      thermal and mechanical stimulations test
    

Intervention name(s): Paracetamol (drug)
Intervention type(s): Drug
Intervention description(s): Randomized, single-center, placebo-controlled, double-blind, cross-over in 100 healthy volunteers meeting the inclusion criteria and receiving 2g of paracetamol orally or placebo on two study periods separated by one week.
Intervention MeSH terms: Acetaminophen
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: pharmacogenetic of paracetamol; Pain threshold
A Healthy Volunteer PK/PD, Safety and Tolerability Study of Second Generation Andexanet Alfa
Condition: Bleeding
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, study in healthy volunteers dosed to steady state with
      fXa inhibitors, designed to (1) demonstrate PK/PD comparability between andexanet
      manufactured by the Generation 1 and Generation 2 processes, (2) evaluate the degree to which
      the Generation 2 andexanet reverses fXa-inhibitor-induced anticoagulation in comparison to
      placebo, and (3) evaluate safety of Generation 2 andexanet.
    


Intervention name(s): Andexanet alfa (Gen 1 Process 2); Apixaban 5 MG; Rivaroxaban 20 MG; Enoxaparin sodium; Edoxaban 60 MG; Andexanet alfa (Gen 2); Andexanet alfa (Gen 1 Process 3); Apixaban 10 MG; Rivaroxaban 10 MG
Intervention type(s): Biological; Drug; Drug; Drug; Drug; Biological; Biological; Drug; Drug
Intervention description(s): factor Xa inhibitor antidote; factor Xa inhibitor; factor Xa inhibitor; low molecular weight heparin; factor Xa inhibitor; factor Xa inhibitor antidote; factor Xa inhibitor antidote; factor Xa inhibitor; factor Xa inhibitor
Intervention MeSH terms: Enoxaparin; Rivaroxaban; Apixaban; Edoxaban; Enoxaparin sodium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of the Safety, Pharmacokinetic Drug Interaction and Efficacy of ETC-1002 and Atorvastatin in Subjects With Hypercholesterolemia
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the safety, atorvastatin pharmacokinetics, and LDL-C lowering efficacy
      of ETC-1002 versus placebo in hypercholesterolemic subjects on background therapy of
      atorvastatin 10 mg.
    


Intervention name(s): ETC-1002; Placebo; Atorvastatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Week 1-2, 60 mg/day; Week 3-4, 120 mg/day; Week 5-6, 180 mg/day; Week 7-8, 240 mg/day; Placebo once daily for 8 weeks; Atorvastatin 10mg once daily for 8 weeks
Intervention MeSH terms: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid; Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Atorvastatin; Drug-drug interaction; Combination therapy
Drug Interaction Study of Clopidogrel and Rosuvastatin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if clopidogrel inhibits hepatic uptake transport of
      rosuvastatin clinically.
    


Intervention name(s): Rosuvastatin; Clopidogrel
Intervention type(s): Drug; Drug
Intervention description(s): Rosuvastatin 20 mg PO x 1; Clopidogrel 300 mg PO x 1 (30 minutes prior to rosuvastatin dose); Clopidogrel 75 mg PO x 1 (24 hours post-rosuvastatin dose)
Intervention MeSH terms: Clopidogrel; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: rosuvastatin; clopidogrel; pharmacokinetics; drug interaction; healthy volunteer; drug transporter
Improving Diabetes Through Lifestyle and Surgery
Condition: Obesity; Type 2 Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Weight loss is effective in reducing many complications of obesity, with the majority of
      patients who undergo bariatric surgery having substantial improvements in their
      weight-related illnesses. The investigators propose a pilot study in 45 subjects with mild to
      moderate obesity to compare how losing 10% of initial body weight via one of three common
      weight loss strategies (medical weight loss with a low calorie diet, Roux-en-Y gastric bypass
      surgery, and adjustable gastric banding) affects diabetes. While the investigators do not
      expect this pilot study to provide definitive answers, it will provide valuable information
      to design a larger trial which will help guide therapy for people with mild-moderate obesity
      and substantial comorbidities.
    


Intervention name(s): Gastric Banding; Medical Weight Loss; Gastric Bypass
Intervention type(s): Procedure; Behavioral; Procedure
Intervention description(s): Laparoscopic Adjustable Gastric Banding using the LapBand; Weight loss intervention using diet (meal replacments), physical activity and behavioral techniques administered with weekly one-on-one counselling by dieticians; Laparoscopic Roux-en-Y Gastric Bypass
Other intervention name(s): HMR meal replacements will be used
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Diabetes
Effects of SIMEOX on Flow and Volume in Healthy Subjects and Patients With COPD
Condition: Healthy; Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      This study will investigate the effects on the SIMEOX technology on flow and volume generated
      in healthy subjects and patients with COPD
    

Detailed description: 
      This is a crossover study assessing the immediate physiological effects of SIMEOX and a PEP
      device on the exhalation phase in healthy subjects and patients with COPD.

      Participants will perform (1) a slow vital capacity, (2) a maximal expiration from total lung
      capacity to residual volume with SIMEOX, (3) a maximal expiration from total lung capacity to
      residual volume with a PEP device.
    

Intervention name(s): SIMEOX; PEP; Spontaneous Exhalation
Intervention type(s): Device; Device; Other
Intervention description(s): SIMEOX is a device generating a succession of gentle depression at the mouth.; A PEP device (Pari-PEP) will be used to provoke a positive expiratory pressure while exhaling, thereby stabilizing the airways during expiration.; A slow vital capacity maneuver will be performed according to the guidelines, from total lung capacity to residual volume
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Oocyte Vitrification on Fertilization Rate, Embryo Quality and Development
Condition: Fertility
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Indications for oocyte (egg) vitrification (fast freezing) include the preservation of
      reproductive competence of young cancer patients who need chemotherapy, pelvic radiation, or
      surgical removal of ovaries for treatment. Furthermore, the ability to freeze oocytes allows
      patients to reduce the number of embryos frozen, thereby circumventing the moral and ethical
      dilemmas of having left-over embryos in cryostorage. In addition, oocyte cryopreservation
      could allow women to delay childbearing if they want or need to. Until recently, conventional
      cryopreservation protocols have remained too inefficient for practical application in an
      infertility center. Very little is known about the effects of vitrification on oocytes and
      subsequent embryo development, especially using the sibling model (group of oocytes from the
      same cohort of ovarian follicles within patient). The purpose of this study is to examine the
      effect of oocyte vitrification on fertilization rates, embryo quality and development.
    


Intervention name(s): Freezing
Intervention type(s): Procedure
Intervention description(s): Vitrification
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: Vitrification; Egg Freezing; Oocyte Cryopreservation
A Phase 1 (Ph1), Single Dose (SD), GSK961081 Absorption, Distribution, Metabolism, and Excretion (ADME) Study in Healthy Subjects
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      Batefenterol (GSK961081) is a bifunctional bronchodilator that is being developed for the
      treatment of Chronic Obstructive Pulmonary Disease (COPD). Absorption, metabolism and
      excretion of batefenterol have been studied in animals, in vitro, and in previous clinical
      studies; however, the elimination routes and metabolic pathways of batefenterol have not been
      fully elucidated in humans. This is an open-label, single centre, non-randomised, 2-period
      single-sequence crossover, mass balance study to determine total radioactivity (drug related
      material) in plasma, the rate and extent of excretion of total radioactivity in urine and
      faeces and the total recovery of radioactivity of [14C] GSK961081 administered as a single IV
      dose (concomitant with an inhaled non-radiolabelled dose) and a single oral dose, in healthy
      male subjects. A total of 6 healthy male subjects will be enrolled. The duration of each
      subject in the study is up to 11 weeks, which consists of a screening visit, 2 Treatment
      Periods, and a follow up visit.
    


Intervention name(s): [14C]-GSK961081 solution for IV infusion; [14C]-GSK961081 oral solution; GSK961081 dry powder for inhalation
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects will receive 10 mL of solution equivalent to 4 mcg of [14C]-GSK961081 (approximately 6.2 kilobecquerel [kBq]) intravenously as a single dose over 1 hour.; Subjects will receive 10 mL of solution equivalent to 200 mcg of [14C]-GSK961081 (approximately 311 kBq) orally as a single dose with up to 250 mL of water.; Subjects will receive single dose of 4 actuations of 300 mcg GSK961081 per actuation (1200 mcg GSK961081 total) as inhalation immediately after the start of infusion.
Intervention MeSH terms: Pharmaceutical Solutions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: total radioactivity; [14C]-GSK961081; Pharmacokinetics; Chronic Obstructive Pulmonary Disease (COPD); Microtracer
CLEAR CARE® PLUS for Presbyopic Contact Lens Wearers
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate CLEAR CARE® PLUS (CCP) compared to non-HYDRAGLYDE®
      multi-purpose contact lens solutions in presbyopes currently wearing soft contact lenses and
      experiencing symptoms of dryness.
    


Intervention name(s): 3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix; Habitual Multi-Purpose Contact Lens Solution; Habitual Contact Lenses
Intervention type(s): Device; Device; Device
Intervention description(s): For cleaning, disinfection and overnight storage of contact lenses; Participant's habitual contact lens brand worn in a daily wear modality for 30 days.
Other intervention name(s): CLEAR CARE® PLUS
Intervention MeSH terms: Hydrogen Peroxide; Contact Lens Solutions; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Contact lens induced dryness
Drug-drug Interaction Study With MDV3100 (ASP9785) and Gemfibrozil and Itraconazole
Condition: Healthy Subjects; Pharmacokinetics; Drug-Drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to assess possible drug-drug interactions between MDV3100 and gemfibrozil and MDV3100
      and Itraconazole.
    


Intervention name(s): MDV3100; Gemfibrozil; Itraconazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral; Oral; Oral
Other intervention name(s): ASP9785; Xtandi; enzalutamide
Intervention MeSH terms: Itraconazole; Gemfibrozil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Phase 1; MDV3100; Gemfibrozil; Itraconazole; Xtandi; enzalutamide