bioihbjkbjnl/mcl2 huggingface dataset:
Randomized, Double-Blind, Placebo-Controlled Study of Larazotide Acetate in Subjects With Active Celiac Disease
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was conducted to assess the safety and efficacy of larazotide acetate versus
      placebo in inducing remission in subjects with active celiac disease.
    

Detailed description: 
      This was an outpatient, randomized, parallel- group, double-blind, multicenter, 8-week study
      with three treatment arms: larazotide acetate 4 mg TID, larazotide acetate 8 mg TID and
      placebo TID in subjects with celiac disease. The primary objective was to assess the efficacy
      of larazotide acetate versus placebo in inducing remission in subjects with active celiac
      disease, as defined by an improvement in the Villous Height to Crypt Depth (Vh:Cd) ratio,
      obtained by duodeno-jejunal biopsy. Secondary objectives included assessment of the safety
      and tolerability of larazotide acetate, to prospectively validate the components of a
      composite weighted index of celiac disease activity (celiac disease Activity Rating Score,
      CeDARS), individually and as a whole, to To compare the CeDARS against the Clinician Global
      Assessment of disease (CGA), Psychological Well Being Index and the Short Form 12 version 2
      (SF-12 v2) health survey and to assess the effects of larazotide acetate on inflammatory
      markers in subjects with active celiac disease.
    

Intervention name(s): larazotide acetate; placebo
Intervention type(s): Drug; Drug
Intervention description(s): gelatin capsule; gelatin capsule
Other intervention name(s): AT-1001; INN-202
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized, parallel- group, double-blind, multicenter
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Treatment; Active; Celiac; Remission; Induction
Study of the Anti-HCV Drug (BMS-790052) Combined With Peginterferon and Ribavirin in Patients Who Failed Prior Treatment
Condition: Hepatitis C Virus
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether BMS-790052 added to Peginterferon Alfa-2a
      and ribavirin can result in higher cure rates in patients who previously failed therapy and
      may have limited response to retreatment with Peginterferon Alfa-2a and ribavirin alone.
    


Intervention name(s): BMS-790052; BMS-790052; Placebo; peginterferon alfa-2a; ribavirin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Film coated tablet, Oral, 20 mg, once daily, 24 weeks; Film coated Tablet, Oral, 60 mg, once daily (divided dose taken BID), 48 weeks; Film coated tablet, Oral, 0mg, Once daily, 24 weeks; Solution for injection, Subcutaneous injection, 180 µg, weekly, 24 or 48 weeks; Film coated tablet, Oral, 1,000 or 1,200 mg based on weight, divided dose taken twice a day (BID), 48 weeks
Other intervention name(s): Pegasys®; Copegus®
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Comparison of Effectiveness Between the Combination of Lidocaine Sprayed at Laryngeal Inlet and on the Cuff of Endotracheal Tube Versus Intravenous Lidocaine for Reducing Cough During Extubation
Condition: Reducing Cough During Extubation
MeSH terms: Cough
Study type: Interventional

Summary: 
      Coughing during extubation of endotracheal tube (ETT) is a common problem that leads to poor
      surgical results including hemodynamic change, rebleeding at the surgical wound and wound
      dehiscence. Recently, lidocaine has been introduced for reducing coughing during extubation.
      However, data comparing routes of lidocaine application are lacking, thus, this study
      compared the combination of lidocaine sprayed on laryngeal inlet and cuff of ETT versus
      intravenous lidocaine injection for efficacy in reducing coughing
    

Detailed description: 
      A prospective randomized control trial was conduct with 164 patients. They were randomly
      allocated into Gr. A and B. Group A received four puffs of 10% lidocaine sprayed at the cuff
      of ETT and four puffs at laryngeal inlet whereas Gr. B received 15 mg/kg of 2% lidocaine
      intravenous injection prior to extubation. The same general anesthesia protocol was applied
      in all of the patients. Incidence and severity of cough during extubation was evaluated.
      Furthermore, incidence of 24-hour postoperative adverse events (including sore throat,
      dysphagia, and hoarseness) and hemodynamic response after extubation were analyzed.
    

Intervention name(s): 10% lidocaine sprayed; 2% lidocaine intravenous
Intervention type(s): Drug; Drug
Intervention description(s): four puffs of 10% lidocaine sprayed at the cuff of ETT and four puffs at laryngeal inlet; 15 mg/kg of 2% lidocaine intravenous injection prior to extubation
Other intervention name(s): 10% Xylociane; 2% Xylocaine
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The randomized controled trial was conducted. the investigator allocated patient into two arms. Group A received four puffs of 10% lidocaine sprayed at the cuff of ETT and four puffs at laryngeal inlet whereas Gr. B received 15 mg/kg of 2% lidocaine intravenous injection prior to extubation
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Oral and Intravenous GSK1322322 in Healthy Subjects
Condition: Infections, Bacterial
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This first time in human (FTIH) study will be the first administration of GSK1322322 as an
      intravenous formulation and will investigate safety, tolerability, and pharmacokinetics in
      healthy subjects. One cohort of subjects will undergo bronchoalveolar lavage (BAL) for
      determination of GSK1322322 concentrations in lung with simultaneous comparison to plasma
      concentrations to evaluate drug penetration in the lung. The study will evaluate the absolute
      bioavailability of an oral tablet formulation as compared to the IV formulation.In addition,
      Amendment 01 will enable the investigation of an improved IV formulation (GSK1322322J
      mesylate salt) in an additional repeat dosing cohort and the supra-therapeutic cohort.
    


Intervention name(s): 500mg IV GSK1322322/placebo; 1000mg oral GSK1322322/placebo; 1000mg IV GSK1322322/placebo; 1500mg oral GSK1322322/placebo dose; 1500mg IV GSK1322322/placebo; 2000mg IV GSK1322322J/placebo; 3000mg IV GSK1322322J/placebo; 1000mg IV GSK1322322J/placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 500mg IV; 1000mg oral; 1000mg IV; 1500mg oral; 1500mg IV; 2000mg IV; 3000mg IV; 1000mg IV
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: healthy subjects; double-blind; FTIH; dose-escalation; absolute bioavailability; GSK1322322; BAL
Study of Aramchol in Patients With Fatty Liver Disease or Nonalcoholic Steatohepatitis
Condition: Non-Alcoholic Fatty Liver Disease; Nonalcoholic Steatohepatitis; Metabolic Syndrome
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Metabolic Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary purpose: Compare the changes in liver triglycerides concentration in the Aramchol
      versus the placebo arm following three month treatment.

      Secondary purpose: Comparing liver enzymes, markers of endothelial dysfunction, insulin
      resistance, SCD1 activity and cholesterol synthesis and lipid levels, between the Aramchol
      and the placebo arms.
    

Detailed description: 
      A Phase II, multicenter, double blind, randomized, placebo controlled study on the effect of
      Aramchol on liver triglycerides concentration in patients with steatosis due to NAFLD or NASH

      The purpose of the study is to test whether Aramchol will reduce safely and effectively liver
      fat concentration in patients with NAFLD and NASH.

      Aramchol inhibits the liver enzyme Stearoyl Coenzyme A Desaturase (SCD). It reduces fatty
      acid synthesis while increasing fatty acid oxidation. It was shown to reduce liver fat in
      animal models with diet induced Fatty Liver. It has also marked hypocholesterolemic effects,
      mainly via upregulation of theABCA1 cholesterol transporter. It thus causes(incomplete) SCD
      inhibition while being antiatherogenic

      Primary purpose: Compare the changes in liver triglycerides concentration in the Aramchol
      versus the placebo arm following three month treatment.

      Secondary purpose: Comparing liver enzymes, markers of endothelial dysfunction, insulin
      resistance, SCD1 activity and cholesterol synthesis and lipid levels, between the Aramchol
      and the placebo arms.
    

Intervention name(s): Aramchol; Aramchol; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 100mg/d tablets packaged in bottles given orally once a day in the morning within 10 minutes after breakfast for a total period time of 3 months; 300 mg/d tablets packaged in bottles given orally once a day in the morning within 10 minutes after breakfast for a total period time of 3 months; tablets packaged in bottles given orally once a day in the morning within approximately 10 minutes after breakfast
Other intervention name(s): Arachidyl amido cholanoic acid; Arachidyl amido cholanoic acid
Intervention MeSH terms: Cholic Acids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: NAFLD; NASH; Fatty Liver; Metabolic Syndrome; Endothelial Dysfunction; Insulin Resistance; Liver Fat
Drug-drug Interaction Between Rifampicin and Progestins/Ethinylestradiol and Midazolam
Condition: Biological Availability
Study type: Interventional
Phase: Phase 1

Summary: 
      Quantify the effect of a probe CYP3A4 inducer (Rifampicin) on the pharmacokinetics of
      levonorgestrel, norethindrone, desogestrel, dienogest, drospirenone,estradiol and midazolam
    


Intervention name(s): levonorgestrel/ Microlut; Norethindrone/ Noriday; Desogestrel/ Cerazette; Dienogest/ Visanne; Drospirenone, Ethinylestradiol/ Yasmin; Midazolam/ Midazolam-ratiopharm; Rifampicin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): In Period 1, 0.03 mg single dose administered as 1x0.03 mg tablet on Study Day 1, In Period 2, 0.03 mg single dose administered as 1x0.03 mg tablet on Study Day 15 In Period 3, 0.03 mg single dose administered as 1x0.03 mg tablet at Study Day 26; In Period 1, 0.35 mg single dose administered as 1x0.35 mg tablet on Study Day 1, In Period 2, 0.35 mg single dose administered as 1x0.35 mg tablet on Study Day 15 In Period 3, 0.35 mg single dose administered as 1x0.35 mg tablet at Study Day 26; In Period 1, 0.075 mg single dose administered as 1x0.075 mg tablet on Study Day 1, In Period 2, 0.075 mg single dose administered as 1x0.075 mg tablet on Study Day 15 In Period 3, 0.075 mg single dose administered as 1x0.075 mg tablet at Study Day 26; In Period 1, 2 mg single dose administered as 1x2 mg tablet on Study Day 1, In Period 2, 2 mg single dose administered as 1x2 mg tablet on Study Day 15 In Period 3, 2 mg single dose administered as 1x2 mg tablet at Study Day 26; In Period 1, 3 mg drospirenone, 0.03 mg ethinylestradiol single dose administered as 1x3mg drospirenone, 0.03 mg ethinylestradiol tablet on Study Day 1, In Period 2, 3 mg drospirenone, 0.03 mg ethinylestradiol single dose administered as 1x3mg drospirenone, 0.03 mg ethinylestradiol tablet on Study Day 15, In Period 3, 3 mg drospirenone, 0.03 mg ethinylestradiol single dose administered as 1x3mg drospirenone, 0.03 mg ethinylestradiol tablet on Study Day 26,; In Period 1, 1 mg single dose administered as 1x0.5 ml oral solution on Study Day 1, In Period 2, 1 mg single dose administered as 1x0.5 ml oral solution on Study Day 15 In Period 3, 1 mg single dose administered as 1x0.5 ml oral solution at Study Day 26; In period 2, 10 mg (suspension, 0.5 ml) for 11 days at 10 mg/day In period 3, 600 mg (film-coated tablets) for 11 days at 600 mg/day
Intervention MeSH terms: Rifampin; Dienogest; Drospirenone; Midazolam; Levonorgestrel; Ethinyl Estradiol; Norethindrone; Norethindrone Acetate; Desogestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Aerobic Interval Training in Patients With Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of aerobic interval training in patients
      with paroxysmal or persistent atrial fibrillation, especially to see if the burden of atrial
      fibrillation and symptoms are reduced.
    

Detailed description: 
      Long term endurance sport practice is associated with a higher incidence of atrial
      fibrillation. Moderate/light physical activity seems to be associated with a lower incidence.
      The underlying mechanisms are uncertain. In order to examine the effect of training in this
      population, the investigators will perform a randomised controlled study with aerobic
      interval training in patients with paroxysmal/persistent atrial fibrillation.
    

Intervention name(s): Interval training
Intervention type(s): Behavioral
Intervention description(s): Aerobic interval training will be performed with 4 times of 4 minutes intervals at an intensity of 90-95% of maximum heart rate and active pauses of 3 minutes between intervals. 3 times a week for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Atrial fibrillation; Motor activity
Determination of Exercise Behavior in Patients With Juvenile Idiopathic Arthritis
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional

Summary: 
      Juvenile idiopathic arthritis (JIA) is one of the most common rheumatic diseases in
      childhood, affecting at least 1 in 1000 children. Children with JIA experience joint
      inflammation and swelling, pain and tenderness, morning stiffness, limited mobility. Children
      with JIA complain pain and have lower functional ability and decreased quality of life
      compared with their peers. Many studies have reported that patients with JIA have low
      physical activity levels and also exercise therapy is considered an important component of
      the treatment of JIA. Nowadays, studies for evaluating exercise behaviours in order to cope
      with physical inactivity for many chronic diseases are becoming increasingly important.The
      objective of this study is to determine exercise behaviour in patients with JIA.
    


Intervention name(s): Assessing exercise behavior
Intervention type(s): Diagnostic Test
Intervention description(s): 11-point Numeric Analogue Scale (NRS) for satisfaction of exercising, Exercise Stages of Change Scale-Short Form (ESCS), Exercise Self-Efficacy Scale (ESES), and Decisional Balance Scale (DBS) for exercise behaviour will be inquired for the patients with JIA.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Juvenile Idiopathic Arthritis; exercise; behavior
Effects of Anesthesia on Tumor Immunity and Insulin Resistance During Perioperative Period
Condition: Anesthesia; Cervical Cancer; Carbohydrate; Tumor Immunity
MeSH terms: Uterine Cervical Neoplasms; Insulin Resistance
Study type: Interventional

Summary: 
      To evaluate the effects of preoperative oral carbohydrate on postoperative insulin resistance
      and tumor immunity in cervical cancer patients with neoadjuvant chemotherapy.
    

Detailed description: 
      Fifty-one patients undergoing neoadjuvant chemotherapy and radical hysterectomy with
      bilateral pelvic lymph node dissection were randomized to receive 300mL of an oral
      carbohydrate liquid supplement 2 hour before surgery(CHO group) or to fast on standard
      hospital protocol (8 hour fasting for solid and 4 hour fasting for clear liquid)(FAST
      group).According to inclusion and exclusion standards, twenty-six patients undergoing the
      same surgery and standard fasting were selected as control group. Baseline and postoperative
      measurements of insulin sensitivity were assessed in term of fasting plasma
      glucose(FPG),fastingainsulin(FINS),HOMA-insulinaresistance(HOMA-IR),HOMA-insulin secretion
      function index(HOMA-IX) , HOMA-beta cell function index(HOMA-β),serum C-peptide and
      glucagon.Baseline and postoperative measurements of tumor immunity were evaluated using NK
      cell and T-cell dynamics.VAS score was introduced to assess preoperative comfort.
    

Intervention name(s): oral carbohydrate liquid
Intervention type(s): Other
Intervention description(s): patients undergoing neoadjuvant chemotherapy and radical hysterectomy with bilateral pelvic lymph node dissection were randomized to receive 300mL of an oral carbohydrate liquid supplement 2 hour before surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Imaging Study to Compare Effects of Darolutamide and Enzalutamide With Respect to Placebo on the Blood Flow in the Brain in Healthy Male Volunteers.
Condition: Cerebrovascular Circulation
Study type: Interventional
Phase: Phase 1

Summary: 
      The current study would investigate the effects of a single dose of darolutamide and
      enzalutamide compared with placebo and compared to each other on human brain blood flow using
      arterial spin labeling magnetic resonance imaging (ASL-MRI), a non-invasive MRI technique.
      The change in cerebral blood flow was an indirect measure of brain penetration.

      The risk of drug-associated CNS-related adverse events was likely to be correlated with the
      concentration of the drug in the brain. In contrast to enzalutamide, preclinical studies of
      darolutamide indicate that its brain penetration was much lower.

      The aim of this study was to determine whether there was a difference between darolutamide
      and enzalutamide compared to placebo in cerebral blood flow and thus in brain penetration.
    

Detailed description: 
      The primary objective was to investigate drug-induced changes in grey matter cerebral blood
      flow during single-dose treatment with darolutamide or enzalutamide as compared to placebo
      using voxel-wise quantification of the grey matter for the entire brain.

      The secondary objective was to investigate drug-induced changes in regional cerebral blood
      flow in brain areas related to cognitive function after single-dose treatment.
    

Intervention name(s): Darolutamide (BAY1841788); Enzalutamide; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): 300 mg tablet darolutamide, once orally; 4 x 40 mg capsules, once orally; 4 placebo tablets, once orally
Other intervention name(s): Darolutamide: ODM-201; MDV3100; Darolutamide-matching placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy volunteers; Magnetic Resonance Imaging (MRI)
Transcranial Magnetic Stimulation for Treatment of Methamphetamine Dependence
Condition: Methamphetamine-dependence
Study type: Interventional

Summary: 
      Repetitive transcranial magnetic stimulation (rTMS) was used to treat methamphetamine (MA)
      addiction in previous studies, while the evidence-based protocols still required. The aim of
      this research is to evaluating the effectiveness and safety of rTMS treatment in improving
      the days of abstinence maintenance. In addition, treatment effect on cognitive impairment,
      psychological craving and depression are also evaluated during the study.
    

Detailed description: 
      First, a multicenter, double-blind, randomized control study is going to be carried out. 100
      recruited patients will be randomized assigned to the intervention group and the control
      group, receiving either 4-week of repetitive transcranial magnetic stimulation (rTMS)
      treatment or 4-week of sham rTMS treatment. Both groups will receive 12-week urine drug test
      follow-up (1 time per week). Negative rate of urine test during the follow-up period is set
      as primary outcome. Cognitive function, craving, depression are also evaluated before and
      after the intervention.

      Secondly, another 40 patients will be recruited from these 100 patients (20 subjects each
      group). Magnetic resonance spectroscopy (MRS) test is applied to investigate the potential
      neurobiological mechanism of rTMS treatment. This study will be very helpful to develop an
      evidence-based rTMS treatment protocols for MA dependent patients and decrease risk of
      relapse for both the patients and their families.
    

Intervention name(s): rTMS treatment group; sham rTMS treatment group
Intervention type(s): Device; Device
Intervention description(s): For rTMS treatment, we will stimulate the dorsal lateral prefrontal cortex of each patients using the iTBS pattern everyday. Treatment will lasted for 30 days.; For sham rTMS treatment, we will stimulate the dorsal lateral prefrontal cortex of each patients using the sham iTBS pattern and sham coil everyday for 30 minutes. Treatment will lasted for 30 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: repetitive transcranial magnetic stimulation (rTMS); randomized clinical trials; treatment; craving; cognitive function
Study of CS-3150 in Patients With Severe Hypertension
Condition: Severe Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      To examine antihypertensive effect and safety of administration of CS-3150 in patients with
      severe hypertension (Grade III).
    


Intervention name(s): CS-3150
Intervention type(s): Drug
Intervention description(s): CS-3150 2.5 to 5mg, orally, once daily after breakfast
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: severe hypertension; grade III hypertension; mineralocorticoid receptor antagonist
Positron Emission Tomography (PET) Amyloid Imaging of the Brain in Healthy Young Adult Subjects
Condition: Healthy
MeSH terms: Amyloidosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Amyloid is an abnormal chemical found in the brain of patients with Alzheimer's Disease (AD).
      The study drug helps produce pictures of amyloid in the brain. The purpose of this study is
      to determine how well the study drug performs in young healthy subjects.
    


Intervention name(s): [18F] Flutemetamol
Intervention type(s): Drug
Intervention description(s): Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.
Other intervention name(s): AH110690
Intervention MeSH terms: Flutemetamol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Amyloid; Magnetic resonance imaging; Positron Emission Tomography; Standard uptake value ratios; Healthy Subjects