bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Inhibition of B7-mediated Costimulation on Allergic Airway Inflammation in Mild Atopic Asthmatics
Condition: Atopic Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to determine if treatment with abatacept is effective in decreasing
      allergic airway inflammation in mild, atopic asthmatics. Subjects will be recruited from the
      greater St Louis Metropolitan area. Eligible individuals will undergo a titrated skin prick
      test. Following baseline evaluation, fiberoptic bronchoscopy with segmental allergen
      challenge (SAC) will be performed. The subjects will be randomized to either placebo or
      abatacept. After 12 weeks of study drug, the subjects will undergo repeat SAC. The primary
      endpoint will be to determine if treatment with abatacept results in a 50% or greater
      decrease in the percentage of eosinophils recovered in the bronchoalveolar lavage (BAL) fluid
      following SAC as compared to placebo control. Secondary endpoints include measures of airway
      obstruction and hyperreactivity, airway inflammation and symptoms as well as determination of
      the safety of abatacept administration in this subject population.
    

Detailed description: 
      please see summary
    

Intervention name(s): abatacept; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Treatment with abatacept, 10 mg/kg IV, for 5 doses.; Treatment with Placebo, IV
Other intervention name(s): Orencia; CTLA4Ig
Intervention MeSH terms: Abatacept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Asthma; Allergy
Diet Oil Induced Stimulation of GLP-1
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Activation of G protein-coupled receptor GPR119 stimulates glucagon-like peptide-1
      (GLP-1)release from the intestinal L-cells. Previously, administration of 2-oleyl-glycerol
      (2-OG) to humans significantly increased plasma GLP-1. In the present study we want to test
      the effect in patients with type 2 diabetes. The hypothesis is that we will expect to find a
      significant increased plasma GLP-1 following a meal containing of 2-OG when compared to meals
      containing of olive oil or carbohydrates alone.
    

Detailed description: 
      Activation of G protein-coupled receptor GPR119 stimulates glucagon-like peptide-1
      (GLP-1)release from the intestinal L-cells. Previously, administration of 2-oleyl-glycerol
      (2-OG) to humans significantly increased plasma GLP-1. In the present study we want to test
      the effect in patients with type 2 diabetes. The hypothesis is that we will expect to find a
      significant increased plasma GLP-1 following a meal containing of 2-OG when compared to meals
      containing of olive oil or carbohydrates alone. The aim of the study is to elucidate the
      effect of 2-OG, 'diet oil' on GLP-1 secretion in patients with type 2 diabetes and to explain
      the mechanism behind the known stimulation of GLP-1 release by dietary fat.
    

Intervention name(s): Diet oil; Olive oil; Carrot
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Carrot and diet oil (containing 2-OG) and 1½ g of paracetamol; Carrot and olive oil and 1½ g of paracetamol; Carrot and 1½ g of paracetamol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Glucagon-like peptide-1; Glucose-dependant insulinotropic polypeptide; Glucagon; Peptide PYY; 2-oleyl glycerol
Preliminary Study of the Scale To Assess Ataxia and Neurologic Dysfunction (STAND)
Condition: Spinocerebellar Ataxia - All Sub-types; Friedreich's Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Spinocerebellar Ataxias; Spinocerebellar Degenerations; Friedreich Ataxia; Neurologic Manifestations
Study type: Observational

Summary: 
      The objectives of this study are:

        -  To validate the inter-rater and intra-rater reliability of a new scale for the
           assessment of ataxia and neurologic dysfunction (STAND)

        -  To assess common constructs and correlation between STAND subscale items.
    

Detailed description: 
      There are few validated, comprehensive rating scales for the assessment of ataxia severity.
      The development of a Scale To assess Ataxia and Neurologic Dysfunction (STAND) would examine
      and measure as many facets of ataxia as possible. Scale items to be measured include
      parkinsonism, timed gait analysis, dystonia, neuropathy and peripheral nerve weakness, as
      well as other areas of clinical manifestation for ataxia. This brief but thorough scale
      should yield a thorough measurement of ataxia.
    

Intervention name(s): Ataxia rating scale
Intervention type(s): Other
Intervention description(s): Administer new rating scale for ataxia. This will be administered by two different raters on two separate occassions, 4 to 6 weeks apart.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community members, support group members or clinic patients with ataxia.
Effects of N-acetylcysteine on Low T3 Syndrome
Condition: Acute Myocardial Infarction; Euthyroid Sick Syndrome; Ischemic Heart Disease
MeSH terms: Heart Diseases; Myocardial Infarction; Myocardial Ischemia; Coronary Artery Disease; Euthyroid Sick Syndromes; Syndrome; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      The propose of this study is to determine whether N-acetylcysteine is effective in reversing
      the changes in thyroid hormones seen in critical illness, known as the low T3 syndrome.
    

Detailed description: 
      The low T3 syndrome or nonthyroidal illness is characterized by low levels of T3, normal or
      high normal levels of rT3, low or normal levels of T4 and inappropriately normal or low
      levels of TSH. These changes affect up to 75% of patients and have prognostic implications.

      Interleukin-6 (IL6) seems to have a causative role in the pathogenesis of nonthyroidal
      illness. There is evidence that the reduction in serum T3 was inversely associated with serum
      IL-6, while the rT3 have a positive association. The mechanism of action of cytokines on the
      metabolism of thyroid hormones has not been determined and the potential role of cytokines on
      the deiodases has been the focus of research.

      In a cell culture model study, IL-6 was able to suppress the conversion of T4 to T3 by
      deiodases type 1 and 2 and stimulate the inactivation of T3 by deiodase type 3, a situation
      similar to nonthyroidal illness. The use of N-acetylcysteine prevented this alterations, been
      consistent with the hypothesis that IL6 inhibits the function of the deiodases by increasing
      the oxygen reactive species and by consuming gluthathione or some gluthathione dependent
      cofactor.

      Considering the absence of human studies evaluating the use of N-acetylcysteine in
      nonthyroidal illness, the aim of this study is to investigate whether NAC has in vivo effect
      on changes of thyroid hormones.
    

Intervention name(s): N-acetylcysteine
Intervention type(s): Drug
Intervention description(s): in infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours
Other intervention name(s): NAC; acetylcysteine
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Euthyroid Sick Syndrome; low T3 syndrome; deiodases; oxidative stress; ischemic heart disease
Single Shot Versus Continuous Adductor Canal Block in Patients Undergoing Total Knee Arthroplasty
Condition: Rheumatism Knee
MeSH terms: Rheumatic Diseases
Study type: Interventional

Summary: 
      Adductor canal block (ACB) has emerged as an option for postoperative regional analgesia in
      patients undergoing total knee arthroplasty (TKA).
    

Detailed description: 
      Various approaches to the performance of peripheral nerve blocks for postoperative pain
      control in patients undergoing TKA have been described in the literature. These approaches
      include lumbar plexus block, femoral nerve block (FNB), with or without a sciatic nerve
      block, and most recently the ACB. FNB is a commonly used modality for postoperative analgesia
      after TKA. It is considered by some as the gold standard or the cornerstone of postoperative
      analgesia after TKA. However, FNB reduces quadriceps muscle strength essential for
      mobilization and active contribution in any physical rehabilitation program. Quadriceps
      weakness places the patients at risk of falling. which may be detrimental to postoperative
      recovery. The ACB has recently emerged as an appealing alternative to FNB as it is
      predominately a sensory nerve block of a more distal branch of the femoral nerve ( the
      saphenous nerve).
    

Intervention name(s): single-shot adductor canal block
Intervention type(s): Procedure
Intervention description(s): An ultrasound machine (Philips; Model: OTD020, AcBel Polytech Inc., Taiwan) with a 5-10 MHz linear probe was used to perform the adductor canal block immediately postoperatively.
Other intervention name(s): Saphenous nerve block
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The target population of this study will be patients undergoing primary total knee arthroplasty at Aswan l and Assiut university hospitals
Masking: None (Open Label)
Primary purpose: Treatment
Lactation Inhibition, the Efficiency of Vitamin B6 Versus Cabergoline
Condition: Lactation Suppressed
Study type: Interventional

Summary: 
      Some mothers may seek lactation suppression on personal, social, or medical grounds. To
      reduce congestion symptoms and shorten the duration of milk production lactation suppression
      can be done pharmacologic or non-pharmacologic. The most common drug for this purpose is
      Cabergoline, a dopaminergic agonist, that has significant side effects. Cabergoline is not
      approved for use in patients with hypertensive disorders, fibrotic diseases, heart problems
      or liver disease. Vitamin B6 has also been studied for this indication with no significant
      side effects. All those studies conducted before 1980. There is no current literature on the
      subject. There are no studies comparing Cabergoline to Vitamin B6 for this indication.

      Purpose:

      The aim of this study is to test whether Cabergoline is more effective than vitamin B6 for
      lactation suppression.

      method: A prospective randomized study in the maternity ward at Haemek medical center in
      Afula, Israel.

      Postpartum women without contraindication to any one of the treatments, who are interested in
      a pharmaceutical induced lactation suppression will be divided into two randomized groups:

        1. Administration of Cabergoline (one dose of 1mg, up to 24 hours postpartum, or 0.25 mg
           twice a day for two days)

        2. Administration of Vitamin B6 (200 mg X 3 per day for a week)

      All women will answer a questionnaire to assess breast congestion, milk leakage and breast
      pain on days 0, 2, 7 and 14.
    


Intervention name(s): Cabergoline; Pyridoxine
Intervention type(s): Drug; Drug
Intervention description(s): Administration of Cabergoline (one dose of 1mg, up to 24 hours postpartum, or 0.25 mg twice a day for two days); Administration of Pyridoxine (200 mg X 3 per day for a week)
Other intervention name(s): Vitamin B6
Intervention MeSH terms: Pyridoxine; Vitamin B 6; Cabergoline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Assess Impact of Dysport Injections Early After Stroke on Upper Limb Spasticity Progression
Condition: Stroke; Upper Limb Spasticity
MeSH terms: Muscle Spasticity; Stroke
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate if early administration (i.e. within 12 weeks
      after stroke) of Dysport® 500 U injections may delay the appearance or the progression of
      upper limb symptomatic spasticity.
    


Intervention name(s): Botulinum toxin type A; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): Subjects to receive Dysport® 500U administered intramuscularly in the targeted upper limb.; Placebo administered intramuscularly in the targeted upper limb.
Other intervention name(s): AbobotulinumtoxinA (Dysport®)
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effects of Intraoperative Dexmedetomidine Infusion on Postoperative Bowel Movement in Patients Undergoing Laparoscopic Gastrectomy
Condition: Gastric Cancer Patients Undergoing Laparoscopic Gastrectomy
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators hypothesized that sympatholytic effect of dexmedetomidine would attenuate
      the hemodynamic instability and decrease in the splanchnic blood flow caused by
      pneumoperitoneum during laparoscopic surgery. This study is to investigate the effect of
      intraoperative dexmedetomidine infusion on postoperative bowel movement in patients
      undergoing laparoscopic gastrectomy.
    


Intervention name(s): the dexmedetomidine group; the control group
Intervention type(s): Drug; Drug
Intervention description(s): the dexmedetomidine group: dexmedetomidine infusion from induction of anesthesia to end of surgery; saline infusion from induction of anesthesia to end of surgery
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Keywords: dexmedetomidine; postoperative bowel movement; laparoscopic gastrectomy
Mitomycin-C Injection Therapy in Refractory Esophageal Stricture
Condition: Esophageal Stricture
MeSH terms: Esophageal Stenosis; Constriction, Pathologic
Study type: Interventional

Summary: 
      Intralesional Mitomycin-C (MMC) injection has recently been introduced to resolve refractory
      benign esophageal stricture mostly in children. The investigators aimed to evaluate the
      clinical efficacy of endoscopic postdilation intralesional injection of MMC in adults with
      refractory benign esophageal stricture.
    

Detailed description: 
      The participnts who have refractory benign esophageal stricture even after five or more
      sessions of bougination are prospectively enrolled. A submucosal needle injection of 4mL of a
      MMC preparation (0.5mg/mL) is endoscopically done with a 0.5mL of eight each injection mainly
      into the tearing esophageal wall, after esophageal bougie dilation is done upto 14mm in
      diameter. And then, repeated bouginations combined with MMC injection are done with the
      interval of eight weeks upto 3 times, if dysphagia symptoms recurr with dysphagis score 3 or
      more. Initial and overall clinical success rates are evaluated with drug and
      procedure-related complication rates during the follow-up period of at least 1 year.
    

Intervention name(s): Endoscopic injection of Mitomycin-C on bougie-dilated refractory benign esophageal stricture
Intervention type(s): Procedure
Intervention MeSH terms: Mitomycins; Mitomycin
Intervention model: Single Group Assignment
Intervention model description: Endoscopic intralesional Mitomycin-C injection in patients with refractory benign esophageal stricture
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Esophageal Stricture; mitomycin C; endoscopy
Gait Pattern Analysis and Feasibility of Gait Training With a Walking Assist Robot in Stroke Patients and Elderly Adults
Condition: Stroke; Healthy
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The purpose of this study was to investigate the effects of the new wearable hip assist robot
      developed by Samsung Advanced Institute of Technology (Samsung Electronics Co, Ltd., Korea)
      to gait rehabilitation in elderly adults and stroke patients.
    

Detailed description: 
      Randomized, two treatment groups

      Number of Subjects : 54 subjects (n=27 per group)

      Group 1 : gait rehabilitation with hip assist robot / 10 sessions (5sessions - treadmill gait
      training / 5sessions - overground gait training), 30min per session

      Group 2 : gait rehabilitation without hip assist robot / 10 sessions (5sessions - treadmill
      gait training / 5sessions - overground gait training), 30min per session

      Primary objective is to demonstrate the effects of hip assist robot on spatio-temporal
      parameters measured by motion capture system (Motion Analysis Corporation, Santa Rosa, CA,
      USA), muscle activation patterns measured by surface electromyography (sEMG) (Noraxon Inc.,
      Scottsdale, AZ, USA), metabolic energy cost parameters measured by portable cardiopulmonary
      metabolic system (Cosmed K4B2, Rome, Italy) and foot pressure distribution measured by F-Scan
      Mobile system (Tekscan Inc., South Boston, MA, USA).

      Secondary objective is to demonstrate the effects of hip assist robot on motor function
      improvement evaluated by Berg Balance Scale (BBS), Tinetti performance oriented mobility
      assessment (POMA), Korean version Modified Bathel index (K-MBI), Modified Rankin Scale (MRS),
      Functional Ambulation Classification (FAC), Fugl-Meyer assessment for lower extremity (FMA),
      Korean version Fall Efficacy Scale (K-FES), Manual Muscle Test (MMT) and Range of Motion
      (ROM).
    

Intervention name(s): gait rehabilitation with Samsung Hip Assist v1; gait rehabilitation without Samsung Hip Assist v1
Intervention type(s): Device; Other
Intervention description(s): Participants will participate in 10 sessions of gait rehabilitation with Samsung Hip Assist v1 (5sessions-treadmill gait training / 5sessions-overground gait training), 30min per session; Participants will participate in 10 sessions of gait rehabilitation without Samsung Hip Assist v1 (5sessions-treadmill gait training / 5sessions-overground gait training), 30min per session
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exoskeleton Device; elderly; stroke; gait rehabilitation
A Study to Investigate the Effect of Food, Gender, and Age on the Pharmacokinetic Profile of SUVN-G3031 in Healthy Subjects
Condition: Cognitive Disorders
MeSH terms: Cognitive Dysfunction; Cognition Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to investigate the effect of Food, Gender, and Age on the
      Pharmacokinetic Profile of SUVN-G3031 in Healthy Subjects
    


Intervention name(s): SUVN-G3031
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
TRUST-2: Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH)
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      This was an open-label extension of Study RIV-PH-402, TRUST-1: Treprostinil for Untreated
      Symptomatic Pulmonary Arterial Hypertension (PAH) Trial. Subjects who completed Study
      RIV-PH-402 were eligible to enroll.
    


Intervention name(s): Intravenous Treprostinil
Intervention type(s): Drug
Intervention description(s): Intravenous treprostinil supplied in 20-mL vials and diluted to the appropriate concentration for administration.
Other intervention name(s): Remodulin
Intervention MeSH terms: Treprostinil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Remodulin; 6-Minute Walk Test
Low-volume Polyethylene Glycol Bowel Preparation for Colonoscopy
Condition: Bowel Preparation for Colonoscopy
Study type: Interventional
Phase: Phase 3

Summary: 
      the efficacy and tolerability of a low-volume (2 L) PEG regimen for colonoscopy compared to
      single (4 L) or split-dose (2 L + 2 L) treatments are not different.
    

Detailed description: 
      In-hospital patients were randomly assigned to one of three groups: group 1 single dose
      (PEG-3350; PEG-4 L the day previous of the study, starting at 17:00 and finishing at 21:00
      h); group 2: split-dose (PEG-3350; 2 L the day before 17:00-19:00 h and 2 L same day of the
      procedure 06:00-08:00 am); group 3: low-volume 2 L PEG-solution (same day of the procedure
      06:00-08:00 am).

      The quality of colonic preparation was assessed by the Boston bowel preparation scale (13);
      tolerability (nausea, vomiting, and abdominal pain), compliance, sleep disturbance and
      adverse effects in group 3 were compared with those in groups 1 and 2. The time since the
      last dose of bowel-preparation agent, the time since the last solid food was consumed, the
      approximate amount of bowel preparation taken (0%, 25%, 75%, or 100%), and the start time of
      the colonoscopy were recorded.

      Satisfactory colon preparation was considered when scores of the Boston bowel preparation
      scale were 2/3; otherwise, the procedure was considered unsatisfactory preparation.
    

Intervention name(s): PEG-3350 group 2; PEG-3350 group 1; PEG-3350 group 3
Intervention type(s): Drug; Drug; Drug
Intervention description(s): split-dose (PEG-3350; 2 L the day before 17:00-19:00 h and 2 L same day of the procedure 06:00-08:00 am); PEG-3350; PEG-4 L the day previous of the study, starting at 17:00 and finishing at 21:00 h; low-volume 2 L PEG-solution (same day of the procedure 06:00-08:00 am)
Other intervention name(s): Nulytely; Nulytely; Nulytely
Intervention MeSH terms: Polyethylene glycol 3350
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Colonoscopy; Preparation; Polyp; Polyethylene glycol
An Open-Label Study Investigating MK-8931 in Participants With Mild and Moderate Hepatic Insufficiency (MK-8931-016)
Condition: Amnestic Mild Cognitive Impairment; Alzheimer's Disease; Prodromal Alzheimer's Disease
MeSH terms: Hepatic Insufficiency; Liver Failure; Alzheimer Disease; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      This study consists of Part I and an optional Part II. The purpose of Part I is to compare
      the plasma pharmacokinetics of verubecestat (MK-8931) following administration of a single
      oral dose of 40 mg MK-8931 to participants with moderate hepatic insufficiency (HI) to that
      of healthy matched controls. An interim safety and pharmacokinetic analysis on the basis of
      Part I will be performed in order to support the decision to continue with the optional Part
      II. If a decision to continue with Part II is made, participants with mild HI will be
      enrolled to receive a single oral dose of 40mg MK-8931. If any healthy participants from Part
      I do not meet the matching criteria for Part II additional healthy participants will be
      enrolled.
    


Intervention name(s): MK-8931
Intervention type(s): Drug
Intervention description(s): MK-8931 40 mg
Other intervention name(s): Verubecestat
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment