bioihbjkbjnl/mcl2 huggingface dataset:
The Role of B Cells in Kidney Allograft Dysfunction
Condition: Kidney; Complications, Allograft; Transplantation Infection
Study type: Observational [Patient Registry]

Summary: 
      The purpose of this study is to understand the role of specific B cells in activating or
      repressing an anti-allograft immune response after kidney transplantation. In this study,
      blood will be collected from kidney transplant patients during different timepoints, prior to
      and after their transplant. Knowledge gained from study findings will be used to develop
      therapeutic strategies to prevent antibody-mediated rejection, which is a major cause of
      long-term graft loss in kidney transplant patients.
    

Detailed description: 
      The purpose of this study is to understand the role of specific B cells in activating or
      repressing an anti-allograft immune responses after kidney transplantation. This study aims
      to address two major challenges in kidney transplantation: 1. to guide physicians when
      immunosuppressive drugs are weaned, and 2. to identify patients who are at risk or in the
      process of developing antibody-mediated rejection. In this study, blood will be collected
      from kidney transplant patients during different timepoints, prior to and after their
      transplant. Knowledge gained from study findings will be used to develop therapeutic
      strategies to prevent antibody-mediated rejection, which is a major cause of long-term graft
      loss in kidney transplant patients.
    

Intervention name(s): Immunosuppressive Agents
Intervention type(s): Drug
Intervention description(s): standard of care for patients post-transplant
Other intervention name(s): Prograf, Cellcept
Intervention MeSH terms: Immunosuppressive Agents
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pediatric and Adult patients who are on the waitlist for a kidney or liver, or are about to
        undergo kidney or liver transplantation.
      
Biospecimen description: 
      Whole blood, and plasma or serum
    
Keywords: Bcells; kidney allograft dysfunction; antibody mediated rejection
Drug Discrimination in Methadone-Maintained Humans Study 3
Condition: Drug Dependence
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This study involves giving psychoactive drugs intramuscularly (injected into the muscle of
      the upper arm or the hip) and/or orally, and measuring the participant's ability to tell the
      difference between one drug and another, as well as measuring the effects of the drugs on
      mood, physiology (e.g., heart rate, blood pressure, respiration rate) and behavior. Each
      participant will receive 2-4 of the listed interventions.
    


Intervention name(s): 2-4 of the drugs listed below
Intervention type(s): Drug
Intervention description(s): Cycloserine: 500, 675, 750 mg oral capsules may possibly given. Naloxone: 0.15mg/70Kg or 0.2mg/70kg I.M. injection may possibly be given. Nifedipine: 10, 20 mg oral capsules may possibly be given. Placebo (sugar pill or microcrystalline cellulose): oral capsules may be given. Saline: I.M. injection may possibly be given. Tizanidine: 4, 8, 12 mg oral capsules may possibly be given. Verapamil: 30, 60, 120 mg oral capsules may possibly be given.
Other intervention name(s): Cycloserine: Seromycin; Naloxone: Narcan; Nifedipine: Adalat, Procardia; Placebo; Saline; Tizanidine: Zanaflex; Verapamil: Veralan
Intervention MeSH terms: Cycloserine; Verapamil; Nifedipine; Tizanidine; Naloxone
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Opioid dependence; methadone; opioid
Ivermectin Solution Bioequivalence Study - Fasted
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to compare the pharmacokinetic and bioavailability profile
      (rate and amount of absorption into the bloodstream) of a test formulation of ivermectin
      solution 1 mg/ml with a marketed reference formulation of ivermectin 3 mg tablets when taken
      after an overnight fast .The study is designed in accordance with the EU Note for Guidance on
      the Investigation of Bioavailability and Bioequivalence 2001.
    

Detailed description: 
      Ivermectin is an antiparasitic medicine (i.e. a medicine used to eliminate parasitic worms)
      for oral administration, and is approved in the US and some other countries in a tablet form.
      A new liquid formulation of ivermectin has been developed to facilitate dosing. This is a
      single dose, randomised, crossover study in healthy adult male and female volunteers, with
      doses taken after an overnight fast. Doses will be separated by washout period of at least 14
      days. Twenty-one blood samples will be taken from each volunteer over 144 hours in each
      period. Concentrations of ivermectin in plasma will be measured using a validated
      chromatographic assay (LC-MS/MS). Standard pharmacokinetic parameters will be obtained and
      bioequivalence on the basis of rate and extent of drug absorption will be assessed.
    

Intervention name(s): ivermectin
Intervention type(s): Drug
Intervention description(s): Each subject will receive single doses of (i) 30 ml ivermectin oral solution (30 mg) and (ii) 10 x 3 mg tablets of ivermectin (30 mg) in 2 separate dosing periods with a 14 day wash-out period. Doses will be administered after an overnight fast.
Other intervention name(s): Stromectol
Intervention MeSH terms: Ivermectin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: therapeutic equivalency; pharmacokinetics; fasting; Healthy Volunteers
Cerebral Oxygenation in Total Hip Arthroplasty Patients
Condition: Cerebral Oxygen Desaturation; Post-operative Delirium
MeSH terms: Emergence Delirium
Study type: Interventional

Summary: 
      We plan to investigate the relationship between hypotensive epidural anesthesia for hip
      arthroplasty and cerebral oxygen saturation.
    

Detailed description: 
      The relationship between cerebral oxygenation and blood pressure in patients undergoing
      hypotensive epidural anesthesia has not been completely elucidated. Previous publications
      have demonstrated a low incidence of post-op cognitive dysfunction in patients undergoing
      hypotensive epidural anesthesia for total hip replacement (1-3) and that cerebral blood flow
      velocity is preserved as measured by transcranial Doppler (4). An earlier investigation by
      Dr. Yadeau demonstrated infrequent cerebral oxygen desaturation in spontaneously breathing
      patients undergoing shoulder arthroscopy, even in the presence of hypotension (4), but did
      not investigate outcomes in the cognitive domain or have a control group of patients
      undergoing surgery with general anesthesia. There has only been one study looking at cerebral
      oxygenation and hip surgery, which was performed in elderly patients with fractures. It
      demonstrated that patients with low pre-op regional cerebral oxygen saturation (rSO2) had
      higher incidence of delirium (5) but many of those patients had surgery under general
      anesthesia. Given the costs associated with post-op delirium, cognitive dysfunction and
      stroke (6) and based on the fact that previous publications from this institution have
      demonstrated both a low incidence of cognitive dysfunction and preservation of cerebral blood
      flow velocity using this anesthetic technique, we hypothesized that cerebral oxygen
      desaturation will not occur in this population.
    

Intervention name(s): Cerebral Oximeter
Intervention type(s): Device
Intervention description(s): Use of cerebral oximeter to monitor cerebral oxygenation for occurence of desaturation events.
Other intervention name(s): oximeter
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Effect of Lacosamide 200 mg Twice a Day (Bid) on Single Dose Warfarin 25 mg in Healthy Males
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effect of Lacosamide 200 mg twice a day (bid)
      on single dose pharmacokinetics (PK) and pharmacodynamics (PD) of Warfarin (25 mg) in healthy
      male volunteers.
    


Intervention name(s): Lacosamide; Warfarin
Intervention type(s): Other; Other
Intervention description(s): Strength: 200 mg, Form: Tablet, Frequency: Twice daily, Duration: 9 days; Strength: 5 mg, Form: Tablet, Frequency: 1 single dose in each period
In total, during the two periods, each healthy volunteer will receive 2 single doses 3 weeks apart.
Duration: single dose
Other intervention name(s): Vimpat; Coumadin
Intervention MeSH terms: Lacosamide; Warfarin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Male Healthy Volunteers
Weekly Vitamin D in Pediatric IBD
Condition: Inflammatory Bowel Diseases; Skin Pigmentation
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether weekly dosing of oral vitamin D3 is
      effective in correcting low vitamin D levels in children and adolescents with inflammatory
      bowel disease (also known as Crohn's disease and ulcerative colitis).
    

Detailed description: 
      The role of vitamin D in skeletal health is well established. More recently, vitamin D has
      been implicated in multiple other disease states and is currently a topic of much discussion
      in the pediatric and adult medical literature. Individuals with gastrointestinal or
      hepatobiliary diseases that limit the absorption of dietary vitamin D and those individuals
      with limited sunlight exposure or darker skin color are at risk for suboptimal vitamin D
      status. Recent joint guidelines from the North American and European Societies of Pediatric
      Gastroenterology, Hepatology and Nutrition (NASPGHAN and ESPGHAN, respectively) have
      recommended routine surveillance and treatment for vitamin D insufficiency/deficiency in
      children affected by inflammatory bowel diseases (IBD), namely Crohn's disease (CD) and
      ulcerative colitis (UC). Current recommendations are for prolonged daily dosing of oral
      vitamin D, but studies in children with other chronic diseases have demonstrated the benefit
      of improved compliance with less frequent, higher doses of vitamin D. The primary goal of
      this pilot study is to establish whether weekly dosing of vitamin D can correct suboptimal
      vitamin D status in children with inflammatory bowel disease. A secondary goal is to evaluate
      whether pediatric IBD patients with darker skin respond differently to vitamin D therapy than
      do their lighter-skinned counterparts.
    

Intervention name(s): Vitamin D3 (cholecalciferol)
Intervention type(s): Dietary Supplement
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Inflammatory Bowel Diseases; Vitamin D; Cholecalciferol; Skin Pigmentation
Indocyanine Green Test for Evaluation of Perfusion of Staple Line of the Stomach During Laparoscopic Sleeve Gastrectomy
Condition: Obesity, Morbid; Diabete Type 2; Cardiac Disease; Vascular Diseases
MeSH terms: Vascular Diseases; Heart Diseases; Obesity, Morbid; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      The investigators present the case of a 40-year-old female underwent laparoscopic sleeve
      gastrectomy. Intraoperative indocyanine green test was performed
    


Intervention name(s): Indocyanine green solution
Intervention type(s): Drug
Intervention description(s): 5 ml of ICG were then injected intravenously to identify the stomach, carefully assessing the angle of His (preoperative written informed consent was obtained from the patient).
Adequate perfusion was defined as "the direct and clear visualization of the fluorescence around the gastric tube, after an estimated time of 150-180 s followingi.v. administration".
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Obese patients with BMI >40 kg/m2 underwent laparoscopic Sleeve gastrectomy
      
Keywords: laparoscopic Sleeve gastrectomy; Bariatric Surgery; Indocyanine greene test; gastric fistula
Evaluation of the Efficacy and Safety of Entelon Tab. 150mg in Patients With Osteoarthritis of Knee
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      This clinical trial is planned to prove Entelon tab. arm is not inferior to Celebrex cap. arm
      in terms of the efficacy and safety through the change of K-WOMAC's total score sum in
      patients with osteoarthritis of knee.
    


Intervention name(s): Enteron tab. 150mg(vitis vinifera extract 150mg) : twice daily for 12 weeks; Celebrex cap. (celecoxib 200mg) : once daily, for 12 weeks; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): morning : 1 tab. of active Entelon 150mg plus 1 cap. of placebo Celebrex
evening : 1 tab. of active Entelon 150mg; morning : 1 tab. of placebo Entelon 150mg + 1 cap. of active Celebrex
evening : 1 tab. of placebo Entelon 150mg; morning : 1 tab. of placebo Entelon 150mg + 1 cap. of placebo Celebrex
evening : 1 tab. of placebo Entelon 150mg
Intervention MeSH terms: Celecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Polyphenol-rich Cocoa Products on Cognitive Function
Condition: Healthy Ageing
Study type: Interventional

Summary: 
      This project aims to investigate whether consumption of cocoa polyphenols has an impact on
      cognitive function in individuals aged 50 to 60 years of age and if such an improvement is a
      result of an improvement in risk factors associated with cognitive decline in ageing.
    

Detailed description: 
      Healthy cognitive ageing is an important aspect of the ageing process as it involves larger
      numbers of people compared to those who have already been diagnosed with conditions on the
      dementia spectrum (Deary et al, 2009). Hence, an active effort looking at potential lifestyle
      factor modification interventions to help maintain cognitive well-being are warranted.

      With an ageing population, the prevalence of cognitive syndromes such as Alzheimer's disease
      and Parkinson's disease increases (Vauzour, 2012). Nutritional interventions can play a role
      in successful ageing by helping to delay the onset of age-related conditions (Hendrickx,
      McEwen & van der Ouderaa, 2005; Brown, Riby & Reay, 2009; Monti, Moulton & Cohen, 2015).
      Studies have investigated the potential role of polyphenols as part of a neuroprotective
      lifestyle. Mouse model studies have looked at varying polyphenol sources such as tea (Haque
      et al., 2006; Kaur et al., 2008), blueberry (Shukitt-Hale et al., 2015; Williams et al.,
      2008), Gingko Biloba (Shif et al., 2008) and cocoa (Bisson et al., 2008) to mention a few.

      Ageing and neurodegenerative diseases are caused by neuronal death which in turn can be
      triggered by neurotoxins, neuroinflammation and specific genetic mutations (Bishop, Lu &
      Yankner, 2010). Dietary polyphenols have been observed to provide neuroprotection against
      cellular alteration by modulating the neuronal function against endogenous neurotoxins and
      inhibition of glial induced neuroinflammation (Vauzour, 2012).
    

Intervention name(s): polyphenol rich chocolate bar; polyphenol rich cocoa powder; low polyphenol content chocolate bar; low polyphenol content cocoa powder
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): High polyphenol content chocolate bar. Each participant will consume 581.4mg of polyphenols; High polyphenol content cocoa powder. Each participant will consume 6g containing 554mg of polyphenols; Low polyphenol content matched chocolate bar. Each participant will consume 198.5mg of polyphenols; Low polyphenol content cocoa powder. Each participant will consume 6g containing 191.2mg of polyphenols
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Cognition; Cacao; Flavan-3-ols; Blood Pressure; hemoglobin A1c protein, human; Memory
Effects of Intranasal Corticosteroid and Montelukast On Nasal Allergen Challenges*
Condition: Allergy
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      This study will be a randomized, double blind, placebo-controlled, parallel group study and
      will include subjects with ragweed-induced seasonal allergic rhinitis.
    

Detailed description: 
      The primary goal of this proposal is to assess the ability of an intranasal corticosteroid,
      fluticasone, and montelukast to affect the upper airway and systemic physiologic, biologic
      and clinical parameters occurring after an early and late upper airway allergic response to
      ragweed in ragweed allergic rhiniticsThe assessment of early allergy responses in the nose
      has been fairly well established in our laboratory and we will use methods detailed in
      previous publications (21, 23 24). One potential challenge will be to sample upper airway
      mediators and cytokines without affecting clinical parameters such as symptom scores and
      acoustic rhinometry readings. Moreover, we will need to sample at time points throughout six
      or more hours in order to accurately determine the effects on late phase allergic responses.
      Nasal filter paper sampling is a technique that we are currently engaged in using, and we
      will work with Roche to elute the samples and measure multiple mediators and cytokines.
    

Intervention name(s): Fluticasone; Fluticason
Intervention type(s): Drug; Drug
Intervention description(s): nasal spray; 2 sprays per day in each nostril
Intervention MeSH terms: Fluticasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Ragweed allergies; acoustic rhinometry; nasal allergen challenge
Longitudinal Sleeve Gastrectomy Study Comparing Posterior Crural Repair Versus No Repair
Condition: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the superiority of posterior crural repair during
      sleeve gastrectomy over no repair in decreasing the incidence of symptomatic and clinical
      reflux disease.
    

Detailed description: 
      Longitudinal Sleeve gastrectomy is a type of Bariatric surgery where the stomach is divided
      vertically, reducing it to about 25% of its original size. Obesity itself is an independent
      risk factor for Gastroesophageal reflux disease (GERD); however it has been observed in the
      bariatric surgical community that many Longitudinal Sleeve Gastrectomy (LSG) patients are
      complaining of persisted GERD symptoms after LSG surgery. The incidence of GERD in these
      patients have been reported to be as high as 26%. GERD is an uncomfortable and dangerous
      disease, and if remains unchecked, it can cause ulcer disease, esophagitis, and even
      esophageal cancer. Because of this, bariatric surgeons want to reduce incidence of GERD after
      LSG, which led to multiple additions to the LSG procedures, which are currently being
      examined, namely, combined fundoplication with the sleeve, banded sleeve and a combined
      hiatal repair with SG. However, there have been no randomized comparative clinical trials to
      evaluate GERD as an endpoint after LSG.

      Of all the possible solutions to treat increased reflux after LSG, mentioned previously,
      repairing the hiatus at the time of surgery makes the most sense physiologically. LSG
      dissection requires the obliteration of the left phrenoesophageal ligaments that hold the GE
      junction in place. This essentially creates a weakness in the hiatus that can lead to hiatal
      hernia and subsequent reflux disease. Crural repair at the time of surgery strengthens the GE
      junction and reduces the possibility of hiatal hernia formation. Closing the crus around the
      esophagus may prevent the sleeve from herniating into the chest and reduces the occurrence of
      reflux by repositioning the GE junction into it0s normal location in the abdomen.
    

Intervention name(s): Posterior crural repair
Intervention type(s): Procedure
Intervention description(s): All patients receive gastrectomy, however patients randomized to the experimental arm will also receive posterior crural repair to determine if this will reduce GERD post sleeve gastrectomy.
Other intervention name(s): gastric sleeve with crural repair
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Sleeve gastrectomy; Posterior crural repair