bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Trial of Efficacy and Safety of Subetta in the Treatment of Impaired Glucose Tolerance
Condition: Impaired Glucose Tolerance
MeSH terms: Glucose Intolerance
Study type: Interventional
Phase: Phase 3

Summary: 
      Purpose of the study:

        -  to assess the efficacy of Subetta in the treatment of impaired glucose tolerance

        -  to assess the safety of Subetta in the treatment of impaired glucose tolerance.
    

Detailed description: 
      Design: a multicenter, double-blind, placebo-controlled, parallel-group randomized trial.

      The study will enroll outpatients adults aged 18 to 70 years with impaired glucose tolerance
      (IGT) who did not receive glucose-lowering agents previously. Persons with pre-diabetes,
      obesity (especially with visceral or abdominal obesity), dyslipidemia (with high
      triglycerides and/or low-density lipoproteins), hypertension, diabetes in first-degree
      relatives will be considered as potential candidates to participate in the study.

      After the patient's information sheet and the form of informed consent for participation in
      the study are signed on the screening (visit 0; day from -7 to 0), complaints and history are
      collected, registration of concomitant conditions and diseases, objective examination,
      calculation of body mass index (BMI), oral glucose tolerance test (OGTT), fasting blood
      glucose. Furthermore, blood samples (for testing HbA1c, chemistry and hematology, HLA
      genotyping) and urine sample will be collected; concomitant therapy will be recorded, diet
      and physical activity recommendations will be given. All women of childbearing potential will
      be administered pregnancy tests.

      If eligibility criteria are met and there are no non-inclusion criteria on Visit 1 (Day 1),
      the patient is randomized to one of two groups: the Subetta group (patients will take 2
      tablets twice a day for 12 weeks) or placebo group (patients will take a placebo according to
      the scheme of Subetta for 12 weeks).

      In the course of the study, two more visits in 4 (Visit 2) and 12 (Visit 3) weeks are
      planned, during these weeks complaints are recorded, a patient's examination is recorded,
      therapy compliance and safety are assessed. On Visit 3 OGTT, fasting blood glucose, blood
      samples (for HbA1c, chemistry and hematology) and urinalysis will be performed.

      The duration of observation period shall be up to 13 weeks. During the study the treatment
      for underlying conditions will be allowed with the exception of the drugs indicated in the
      section "Prohibited concomitant therapy".
    

Intervention name(s): Subetta; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration.; Oral administration.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effectiveness of L-ornithine-L-aspartate (LOLA) on Plasma Ammonia in Cirrhotic Patients After TIPS
Condition: Decompensated Cirrhosis; Portal Hypertension; Bleeding Varices; Refractory Ascites
MeSH terms: Hypertension, Portal; Fibrosis; Ascites
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this study is to evaluate the effectiveness of L-ornithine-L-aspartate (LOLA) on
      plasma ammonia in cirrhotic patients after Transjugular Intrahepatic Portosystemic Shunt
      (TIPS) procedure.
    

Detailed description: 
      Patients with successful TIPS deployment are randomized to LOLA arm and blank control arm.
      Plasma ammonia concentrations are measured before TIPS, day 1, day 4 and day 7 after TIPS.
    

Intervention name(s): L-ornithine-L-aspartate
Intervention type(s): Drug
Intervention description(s): The patients will be treated with LOLA (30g per day) for a week after TIPS procedure.
Intervention MeSH terms: N-Methylaspartate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Transjugular Intrahepatic Portosystemic Shunt; TIPS; Liver Cirrhosis; LOLA; L-ornithine-L-aspartate; Refractory Ascites
Inmediate Feeding Tolerance in Acute Pancreatitis
Condition: Acute Pancreatitis Due to Gallstones
MeSH terms: Pancreatitis; Gallstones
Study type: Interventional

Summary: 
      Objective: Determine tolerance of immediate oral intake (8 hours posterior to the beginning
      of treatment) against traditional management (early feeding at 48hr) in patients with mild
      acute pancreatitis of biliary origin.

      Double blind, randomized clinical trial
    

Detailed description: 
      The investigators included patients 15 - 85 years old, any sex. Diagnosis of mild acute
      pancreatitis according to the Ranson, APACHE II and BISAP.

      Signed infromed consent to participate in the study. All participants had a hepatic and
      biliary ultrasound to determine the biliary etiology.

      The investigators excluded patients with pancreatitis of nonbiliary etiology, pregnant,
      severe pancreatitis, cholangitis or choledocholithiasis demonstrated during the hospital stay
      or with other comorbidities.
    

Intervention name(s): TIME OF FEEDING
Intervention type(s): Dietary Supplement
Intervention description(s): Liquid ( Re Feeding 8 h ) OR Enteral Feeding ( re feeding 48 h)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pancreatitis; mild; biliary; referring
A Study of BV-araU in the Treatment of Varicella-Zoster Viral Disease (VZV) in HIV-Infected Children Who Have Not Had Success With or Who Cannot Take Other Treatments for VZV
Condition: HIV Infections; Chickenpox
MeSH terms: Chickenpox; Virus Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      To provide oral sorivudine ( BV-araU ) to pediatric HIV-infected patients with
      varicella-zoster viral disease who have failed or are intolerant of alternative therapy.
    

Detailed description: 
      Any physician qualified to treat pediatric AIDS patients may enroll patients in this study.
    

Intervention name(s): Sorivudine
Intervention type(s): Drug
Intervention MeSH terms: Sorivudine
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Herpes Zoster; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Antiviral Agents; sorivudine; Chickenpox
Study of the Efficacy and Safety of Pegol-Sihematide for Anemia in Patients With Chronic Kidney Disease on Dialysis
Condition: Chronic Kidney Diseases
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effecacy and safety of dialysis centers
      switching its dialysis patients from using recombinant human erythropoietin injection (CHO
      Cell) (ESPO) to Pegol-Sihematide injection on hemoglobin levels and other parameters.
    

Detailed description: 
      This is a phase 3, randomized, multicenter, open-label, active-controlled, non-inferiority
      trial to evaluate the efficacy and safety of from ESPO to monthly Pegol-Sihematide injection
      for the treatment of anemia in participants with chronic kidney disease（CKD）, who are on
      maintenance dialysis. Study included a period of 4 weeks for screening, 8 weeks for baseline,
      16 weeks for dose adjustment, 8 weeks for evaluation, and 28 weeks for extensional treatment
      period. All patients who passed the screening were received ESPO in baseline period, then,
      eligible patients were centrally allocated in a 2:1 ratio to receive Pegol-Sihematide or
      ESPO. Doses of both drugs were adjusted to achieve and maintain hemoglobin levels between
      10.0 and 12.0 g per deciliter for 52 weeks or more. The primary efficacy end point was the
      mean change from the baseline hemoglobin level to the mean level during the evaluation
      period; non-inferiority was established if the lower limit of the two-sided 95% confidence
      interval was -1.0 g per deciliter or higher. Cardiovascular safety was evaluated on the basis
      of an adjudicated composite end point.
    

Intervention name(s): Pegol-Sihematide; ESPO
Intervention type(s): Drug; Drug
Intervention description(s): Participants received Pegol-Sihematide by subcutaneous injection once every 4 weeks ; the dose was adjusted throughout the study to maintain a hemoglobin target range of 10.0-12.0 grams per deciliter (g/dL).; Participants received ESPO by subcutaneous injection or subcutaneous injection weekly. The dose was adjusted throughout the study to maintain a hemoglobin target range of 10.0-12.0 g/dL.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Flupenthixol Decanoate in Methamphetamine Smoking - 1
Condition: Substance-Related Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of flupenthixol decanoate
      for treatment of methamphetamine dependence. Also, study will compare flupenthixol with
      desipramine in blocking methamphetamine self-administration.
    


Intervention name(s): Flupenthixol
Intervention type(s): Drug
Intervention MeSH terms: Flupenthixol; Flupenthixol decanoate
Primary purpose: Treatment
Keywords: methamphetamine dependence
Long-term Efficacy, Safety and Tolerability of ACZ885 in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the long-term safety and tolerability of ACZ885 in patients with
      rheumatoid arthritis, as well as long-term efficacy, long-term preservation and/or
      improvement of joint structure and bone mineral density, and long term maintenance of
      health-related quality of life.
    


Intervention name(s): Canakinumab
Intervention type(s): Drug
Intervention description(s): Canakinumab
Other intervention name(s): ACZ885
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis; Anti-interleukin-1 beta; ACZ885
Imaging Neuroinflammation in Epilepsy With Ferumoxytol MRI
Condition: Epilepsy
MeSH terms: Epilepsy; Neuroinflammatory Diseases
Study type: Interventional

Summary: 
      The investigators plan to study inflammation in the brain (neuroinflammation) in human
      patients with epilepsy using a novel, non-invasive technique that has been proven successful
      in humans with other neuroinflammatory diseases. This technique uses ferumoxytol, a drug with
      minimal side effects that is FDA-approved for the treatment of iron deficiency anemia, as the
      contrast agent in magnetic resonance imaging (MRI). The study will recruit epilepsy patients
      who are admitted to Dartmouth-Hitchcock Medical Center (DHMC) for
      video-electroencephalography (video-EEG) monitoring in order to evaluate their candidacy for
      curative brain surgery. During the hospital stay and after informed consent, the patient will
      receive a standard-dose intravenous injection of ferumoxytol, and undergo one session of MRI
      at 24-48 hours after the injection. The patient will also undergo a separate "baseline" MRI
      session (if not already done at DHMC) at admission or at more than four weeks after the
      injection but before any brain surgery. Brain regions that preferentially uptake ferumoxytol
      are localized by subtracting the post-injection MRI session from the "baseline" MRI session.
      The investigators will investigate whether these regions overlap with the epileptogenic
      focus, namely the region that generates epilepsy and is localized by video-EEG and other
      diagnostic measures. Lastly, for those patient participants who thereafter undergo brain
      surgery, DHMC neuropathologists will use special stains to detect and quantify
      neuroinflammation in brain tissue removed, and the results will serve as the reference for
      the investigators to measure the sensitivity and specificity of ferumoxytol-based MRI in
      detecting neuroinflammation.
    


Intervention name(s): Ferumoxytol injection after focal epileptic seizure followed by iron-sensitive MRI
Intervention type(s): Other
Intervention MeSH terms: Ferrosoferric Oxide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Phase 2 Study of MD-1100 Acetate on Gastrointestinal Transit in Patients With C-IBS
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Study type: Interventional
Phase: Phase 2

Summary: 
      -  The primary objective of this trial is to compare the dose-ranging pharmacodynamic
           effects of orally administered placebo, and 100 and 1000 ug qd of MD-1100 Acetate on
           gastrointestinal transit in patients with C-IBS.

        -  The secondary objectives of this trial are:

             1. To compare the dose ranging pharmacodynamic effects of placebo, and 100 and 1000 ug
                MD-1100 Acetate once daily on time to first bowel movement after first drug intake.

             2. To describe and summarize the effects of placebo, and 100 and 1000 ug MD-1100
                Acetate once daily on stool frequency, stool consistency, ease of passage and
                sensation of incomplete evacuation during the Treatment Period relative to
                Baseline.
    

Detailed description: 
      Using a double-blind, randomized, placebo-controlled, parallel group study design, the
      effects of placebo and two different doses of orally administered MD-1100 Acetate on gastric
      emptying, small bowel transit and total colonic transit will be compared and evaluated in
      patients with C-IBS.

      After eligibility is confirmed, the patient will return for baseline measurement of colonic
      transit to ensure that the transit profile is not greater than the mean transit profile of
      healthy controls in order to avoid a ceiling effect. A patient must have a geometric center
      of ≤2.65 at 24 hours, or ≤3.0 at 24 hours and ≤3.9 at 48 hours in order to be randomized to a
      5-day Treatment Period of study medication. Eligible patients will receive oral study
      medication for 5 days during which colonic transit will be measured.

      Approximately 36 (n=36) patients will be randomized to one of three different treatment
      groups: placebo (n=12), 100 ug MD-1100 (n=12), or 1000 ug MD-1100 (n=12). All dosing of study
      medication will be supervised at the Mayo Clinic.

      Patients will complete a daily Stool Diary to record bowel habits for 5 consecutive days
      during the Pretreatment Period and then for the 5 consecutive days of the Treatment
      PeriodPhysical examinations, vital signs, electrocardiograms, and clinical laboratory tests
      will be performed throughout the study and adverse events will be recorded for safety
      evaluation.
    

Intervention name(s): MD-1100 Acetate
Intervention type(s): Drug
Intervention MeSH terms: Linaclotide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: C-IBS; IBS-C; Constipation-predominant Irritable Bowel Syndrome; Constipation Predominant Irritable Bowel Syndrome; Irritable Bowel Syndrome; IBS; Transit; Scintigraphy; Gastroenterology; Gastrointestinal; GC; MD-1100 Acetate; MD-1100; linaclotide; linaclotide acetate
Monoclonal Antibody Therapy in Treating Patients With Lymphoproliferative Disorder Associated With Immunosuppression Therapy
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoproliferative Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill
      them or deliver cancer-killing substances to them without harming normal cells.

      PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who have
      lymphoproliferative disorder that is associated with immunosuppression therapy.
    

Detailed description: 
      OBJECTIVES: I. Evaluate the efficacy of rituximab in patients with B-cell lymphoproliferative
      disorders while under pharmacologic immune suppression for control of either allograft
      rejection or autoimmune disease. II. Evaluate the safety and direct toxicity of rituximab in
      this patient population, including the potential for opportunistic infections. III. Evaluate
      the secondary consequences of rituximab therapy in this population, including changes in the
      requirement for immunosuppressive drugs, effects on graft rejection, graft survival, and
      severity of autoimmune disease.

      OUTLINE: Patients receive rituximab IV over several hours. Treatment repeats every week for 4
      courses. Patients are followed every month for 6 months, and then every 3 months until
      relapse or 2 years.

      PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study within 1 year.
    

Intervention name(s): rituximab
Intervention type(s): Biological
Intervention MeSH terms: Rituximab
Primary purpose: Treatment
Keywords: childhood Burkitt lymphoma; childhood immunoblastic large cell lymphoma; stage IV adult immunoblastic large cell lymphoma; stage IV adult Burkitt lymphoma; recurrent adult immunoblastic large cell lymphoma; recurrent adult Burkitt lymphoma; stage IV childhood small noncleaved cell lymphoma; stage IV childhood large cell lymphoma; recurrent childhood small noncleaved cell lymphoma; recurrent childhood large cell lymphoma
A Trial of SHR-1210 (an Anti-PD-1 Antibody) in Combination With Apatinib in Patients With Advanced TNBC
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase II, Open-labeled, Randomised, Parallel, Non-comparative, Two-arms,
      Investigator-initiated Clinical Trial of SHR-1210 (Anti-PD-1 Antibody) in Combination With
      Apatinib (VEGFR2 inhibitor) in Subjects with Advanced Triple Negative Breast Cancer. Subjects
      with advanced Triple Negative Breast Cancer will be recruited. Patients will be randomised to
      two treatment arms of this study. One arm is SHR-1210 combination with apatinib daily dosing,
      and the other arm is SHR-1210 combination with apatinib intermittent dosing; each arm will
      enrolle10-29 subjects (Simons two stage design).

      This study aims to evaluate the efficacy and safety of SHR-1210 combination with apatinib in
      the treatment of advanced TNBC.
    


Intervention name(s): SHR-1210; Apatinib
Intervention type(s): Drug; Drug
Intervention description(s): SHR-1210 200mg (3mg/kg for patient whose weight is below 50kg) will be administered as an intravenous infusion over 30 minutes every two weeks until unacceptable toxic effects or disease progression or other termination criteria appeared.; Apatinib 250mg will be taked daily/intermittent dosing until unacceptable toxic effects or disease progression or other termination criteria appeared.
Intervention MeSH terms: Apatinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Study of Unasyn-S 12g/Day for Community Acquired Pneumonia (CAP)
Condition: Pneumonia, Bacterial
MeSH terms: Pneumonia; Pneumonia, Bacterial
Study type: Interventional
Phase: Phase 3

Summary: 
      Unasyn-S 12g/day (3 g four times a day) is the commonly used dosage depending on the severity
      for US, EU, China, Taiwan and Korea for over 20 years, however, Unasyn-S 12g/day has not yet
      been approved in Japan. The purpose of this trial is to evaluate the clinical efficacy and
      safety in Japanese adult subjects with community acquired pneumonia receiving ampicillin
      sodium/sulbactam sodium, 12g/day (3 g four times a day ) IV.
    


Intervention name(s): ampicillin sodium/sulbactam sodium
Intervention type(s): Drug
Intervention description(s): ampicillin sodium/sulbactam sodium is administered 12g/day (3 g four times a day) intravenously for 3 to 14 days
Other intervention name(s): Unasyn-S
Intervention MeSH terms: Ampicillin; Sulbactam
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ampicillin sodium/sulbactam sodium; Unasyn-S; community acquired pneumonia; bacterial pneumonia
Randomized, Placebo-controlled, 2 Period, Single-blind, Sequential, Multiple Ascending Dose Study
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      DS-7309 is being developed for the treatment of type 2 diabetes mellitus (T2DM). This will be
      a randomized, placebo-controlled, blinded, sequential, multiple ascending dose study to
      assess the safety, tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of multiple
      doses of DS-7309 in subjects with T2DM.
    

Detailed description: 
      DS-7309 is being developed for the treatment of type 2 diabetes mellitus (T2DM). This will be
      a randomized, placebo-controlled, single-blind (subject and investigator-blinded,
      sponsor-unblinded), sequential, multiple ascending dose study to assess the safety,
      tolerability, Pharmacokinetic (PK), and Pharmacodynamic (PD) of multiple doses of DS-7309 in
      subjects with T2DM. The safety and tolerability of each new dose level will be tested in a
      single day administration prior to start of repeated dosing.
    

Intervention name(s): DS-7309; placebo; Metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): DS-7309 powder in bottle; placebo to match DS-7309 powder in bottle; Metformin 500mg tablet for Cohort F
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Study of NST-6179 in Healthy Subjects
Condition: Short Bowel Syndrome; Parenteral Nutrition Associated Liver Disease
MeSH terms: Liver Diseases; Short Bowel Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      A double-blind, randomized, placebo controlled, single and multiple oral dose study to assess
      safety and tolerability of single and multiple doses of NST-6179 in healthy male and female
      subjects.
    


Intervention name(s): NST 6179; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): orally administered, fully synthetic medium chain fatty acid (MCFA) analogue; inactive analogue
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment