bioihbjkbjnl/mcl2 huggingface dataset:
GIP Effects at Insulin Induced Hypoglycemia in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Investigation of GIP effects at fasting and hypoglycemia
    


Intervention name(s): Glucose-dependent Insulinotropic polypeptide; saline
Intervention type(s): Other; Other
Intervention description(s): infusion 4 pmol x kg x min first 15 min, thereafter 2 pmol x kg x min
Intervention MeSH terms: Gastric Inhibitory Polypeptide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
A Study to Investigate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Characteristics, and Food Effect of HSG4112
Condition: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      1. Study Objective: The objective of this phase 1 clinical trial is to evaluate the safety,
           tolerability, pharmacokinetic/pharmacodynamic characteristics and food effect of HSG4112
           after oral administration in healthy male subjects.

        2. Study Design and Plan: This study is a dose-block randomized, double-blind,
           placebo-controlled, single and multiple dosing, dose-escalation phase 1 clinical trial.
           A unique randomization number will be assigned to each subject deemed eligible to
           participate in the study based on the inclusion/exclusion criteria. Each subject will be
           randomized to one of the six groups for the single ascending dose (SAD) study or one of
           the three groups for the multiple ascending dose (MAD) study. Each dose group will
           consist of ten subjects, and among the ten subjects, eight subjects will be randomized
           to receive HSG4112 and two subjects will be randomized to receive placebo. The subjects
           will be studied in a double-blind manner and will receive the investigational product
           (i.e., HSG4112 or placebo) via once-daily oral administration. The dosing duration for
           the MAD study is 14 days. When escalating the dose, the Investigator will review all of
           the available safety data from the preceding dose in a blinded manner to ensure if it is
           safe to escalate the dose. In order to evaluate safety and tolerability, assessments,
           such as vital signs, 12-lead electrocardiogram, laboratory test, semen analysis (MAD
           study only), physical examination, and adverse event monitoring will be performed. Blood
           samples will be collected to evaluate the pharmacokinetic/pharmacodynamic
           characteristics of HSG4112.
    


Intervention name(s): HSG4112; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Once-daily oral administration; Once-daily oral administration
Other intervention name(s): 2-(8,8 dimethyl 2,3,4,8,9,10 hexahydropyrano[2,3 f]chromen 3 yl) 5 ethoxyphenol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Probiotics For The Prevention of Antibiotics Associated Diarrhea in the Pediatric Intensive Care Unit
Condition: Critical Illness; Antibiotic-associated Diarrhea
MeSH terms: Diarrhea; Critical Illness
Study type: Interventional

Summary: 
      The goal of this prospective trial is to learn about lactobacillus use in critically ill
      pediatric patients. The main question[s] it aims to answer are:

        -  Is lactobacillus GG effective in preventing antibiotic associated diarrhea in the PICU

        -  Is lactobacillus safe in critically ill pediatric patients Participants will be
           randomized to lactobacillus GG vs placebo while on antibiotics

      If there is a comparison group: Researchers will compare lactobacillus GG to see if it
      prevents antibiotic associated diarrhea.
    

Detailed description: 
      The objective of this study was to assess the efficacy of lactobacillus GG (LGG) to prevent
      antibiotic-associated diarrhea (AAD) in the PICU.

      Design:

      Prospective randomized, double-blind, placebo-controlled trial

      Setting:

      15-20 bed PICU at University of South Alabama, Children's and Women's Hospital in Mobile,
      Alabama.

      Patients:

      Pediatric patients ≤ 17 years and required antibiotic therapy ≥ 72hrs were randomized to
      receive placebo or control (lactobacillus GG). Exclusion criteria included but was not
      limited to antibiotics ≥ 48 hours prior, prior probiotics, pre-existing diarrhea, laxative
      therapy, immunocompromise, and GI disorders.

      Interventions:

      Treatment with LGG (30 x 109 CFU) or a matching placebo capsule was administered twice daily,
      initiated within 24 hours of starting antibiotic therapy and continued for the duration of
      therapy.

      Measurements:

      Diarrhea was defined as stools >200 mL or 200 g per day in a patient over 10 kg and > 20
      mL/kg/day or > 20 g/kg/day in a patient < 10 kg or 3 or more loose stools in 24 hours.
    

Intervention name(s): lactobacillus GG
Intervention type(s): Dietary Supplement
Intervention description(s): probiotic
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Prospective randomized, double-blind, placebo-controlled crossover trial
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Pediatric; PICU
Effect of Brimonidine Tartrate Ophthalmic Solution 0.15% on Pupil Diameter in Normal Eyes
Condition: Healthy
Study type: Observational

Summary: 
      The objective of this study is to evaluate the effect of brimonidine tartrate ophthalmic
      solution 0.15% (Alphagan P) on pupil diameter under different luminance conditions.
    


Intervention name(s): Brimonidine tartrate ophthalmic solution 0.15% (Alphagan P)
Intervention type(s): Drug
Intervention MeSH terms: Brimonidine Tartrate; Ophthalmic Solutions
Time perspective: Prospective
Keywords: Large pupils rendering night vision difficulties such as haloes, glare, and monocular diplopia
Bioequivalence Study of 120 mg Etoricoxib Film-coated Tablets
Condition: Healthy
Study type: Interventional

Summary: 
      The present study was a randomized, open-label, two-period, two-sequence, cross-over study,
      conducted to find out whether the etoricoxib 120 mg film-coated tablet produced by PT Dexa
      Medica (test drug) was bioequivalent to the reference drug (Arcoxia® Film-Coated Tablet 120
      mg, PT. Schering-Plough Indonesia Tbk), under fasting condition with a fourteen days wash-out
      period, involving 26 healthy adult male and female subjects.
    

Detailed description: 
      This was a randomized, open-label, two-period, two-sequence, cross-over study under fasting
      condition with a fourteen days wash-out period, involving 26 healthy adult male and female
      subjects. The participating subjects had an overnight fast and in the next morning were given
      orally either one film-coated tablet of the test drug or one film-coated tablet of the
      reference drug with 200 mL of water. Blood samples were drawn immediately before taking the
      drug (baseline), and at 15, 30, and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48,
      and 72 hours after drug administration, analysed for plasma concentrations of etoricoxib and
      used to evaluate the pharmacokinetics parameters of the single dose administration. After a
      fourteen-day washout period, the procedure was repeated using the alternate drug. The plasma
      concentrations of etoricoxib were determined by using a high pressure liquid chromatography
      with ultraviolet detection (HPLC-UV) method.
    

Intervention name(s): Etoricoxib 120Mg Film-coated Tablet; Arcoxia® 120 mg Film-coated tablet (Frosst Iberica S.A., Spain for Merck Sharp & Dohme (Australia) Pty Limited, Australia, registered by PT. Schering-Plough Indonesia Tbk)
Intervention type(s): Drug; Drug
Intervention description(s): One tablet of the Test drug was given orally (swallowed with 200 mL of water, without chewing), after an overnight fast, and after fasting (pre-dose) blood-sampling.; One tablet of the Reference drug was given orally (swallowed with 200 mL of water, without chewing), after an overnight fast, and after fasting (pre-dose) blood-sampling.
Other intervention name(s): Test; Reference
Intervention MeSH terms: Etoricoxib
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This was a bioequivalence study.
Masking: None (Open Label)
Primary purpose: Other
Effectiveness of Adding Subcutaneous Long-acting Glargine to Insulin Drip Therapy Compared With Standard Insulin Drip Therapy
Condition: Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      The investigators anticipate that the use of Glargine will decrease the duration of an
      insulin drip, the dose of short-acting insulin in the drip, hospital and ICU (intensive care
      unit) length of stay, improve glycemic control, and prevent rebound hyperglycemias when the
      insulin drip is discontinued.
    


Intervention name(s): Glargine
Intervention type(s): Drug
Intervention description(s): Glargine 0.25 units per kg body weight given every 24 hours while patients are receiving intravenous (IV) standard insulin drip therapy
Other intervention name(s): Lantus
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes
AccuCath™ Intravenous (IV) Device Used by Vascular Access Team (VAT)
Condition: Vascular Access Complication
Study type: Interventional

Summary: 
      The study will test a hypothesis that the AccuCath™ System will have a higher rate of
      successful first attempt peripheral intravenous (PIV) placement, higher completion of
      therapy, fewer complications, longer dwell times, and higher user satisfaction compared to
      Conventional IV Catheters.
    

Detailed description: 
      Phase One is designed as a one-arm prospective study to compare patients using the AccuCath™
      Intravenous Catheter System to the results found in literature. Phase Two is designed as a
      two-arm prospective randomized controlled study comparing the AccuCath™ Intravenous Catheter
      System to conventional PIV catheters. This study site will be completing Phase One only.
    

Intervention name(s): AccuCath Intravenous Catheter System
Intervention type(s): Device
Intervention description(s): AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IV Catheter comparison; AccuCath versus Conventional IV Catheters; IV Catheter Study; IV Catheter User Preference Comparison; First Attempt Success Rate for IV Catheters; AccuCath Device Performance; Complication Rates for IV Catheters; Average Dwell Time for IV Catheters; Patient Satisfaction with IV Catheters; Clinician Satisfaction with AccuCath Device Performance
Validity of HER2-amplified Circulating Tumor Cells to Select Metastatic Breast Cancer Considered HER2-negative for Trastuzumab-emtansine (T-DM1) Treatment.
Condition: Metastatic Breast Cancer, HER2 Negative Primary Tumor
MeSH terms: Breast Neoplasms; Neoplastic Cells, Circulating
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients with metastatic breast cancer considered HER2 negative are screened for
      HER2-amplified circulating tumor cells. If at least HER2-amplified circulating tumor cell is
      detected, patients are treated by Trastuzumab - Emtansine (T-DM1) in a single arm phase II
      with an adaptive design.
    


Intervention name(s): Trastuzumab - Emtansine
Intervention type(s): Drug
Intervention MeSH terms: Trastuzumab; Maytansine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metastatic breast cancer; HER2 negative primary tumor; CTC HER2 positive
To Evaluate Food Effect on the Pharmacokinetics of Rebamipide in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open label, single dose, crossover study to evaluate the food effect on
      the pharmacokinetics after single oral dose of "rebamipide SR 150 mg" in healthy adult
      volunteers.
    


Intervention name(s): Rebamipide SR 150mg after high-fat meal; Rebamipide SR 150mg under fasting condition
Intervention type(s): Drug; Drug
Intervention description(s): Test Drug; Reference Drug
Intervention MeSH terms: Rebamipide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
A Comparative Study of Adapalene Gel,0.3% Versus Tretinoin Emollient Cream, 0.05% for the Treatment of Photoaging
Condition: Photoaging; Photodamage
MeSH terms: Skin Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to:

        1. Evaluate the efficacy of Adapalene gel 0.3% compared to Tretinoin Emollient cream 0.05%,
           reducing signs of cutaneous photoageing, measured trough photonumeric scale evaluation,
           investigator evaluation of global response to treatment and subject's evaluation of
           improvement.

        2. Evaluate the safety and tolerability of Adapalene Gel 0.3%, compared to Tretinoin
           Emollient cream 0.05% during 24 weeks of treatment.

      The study has the clinical hypothesis that Adapalene Gel 0.3% is as effective as Tretinoin
      Emollient cream 0.05% in the treatment of cutaneous photoaging.
    


Intervention name(s): Adapalene; Tretinoin
Intervention type(s): Drug; Drug
Intervention description(s): Apply approximately 1 gram of Differin 0.3% every night on the entire face, except near the eye region.; Apply approximately 1 gram of Tretinoin emollient cream 0.05% every night on the entire face, except near the eye region.
Other intervention name(s): Differin® Gel 0.3%; Adapalene Gel 0.3%; Tretinoin emollient cream 0,05%
Intervention MeSH terms: Adapalene; Tretinoin; Emollients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Photoaging; Photodamage; Adapalene; Differin
Chemotherapy Combined With Apatinib and PD-1 Antibody
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The effective rate of second-line and later-line single-agent therapy for advanced gastric
      cancer is limited. This research plan aims to explore whether the combination of drugs can
      further improve the benefits of second-line and above therapies. Previous studies have shown
      that there is a significant synergistic effect between chemotherapy and PD-1 monoclonal
      antibody, or anti-angiogenic TKI drugs and PD-1 monoclonal antibody. This project is planned
      to be based on the classic chemotherapy drugs irinotecan or paclitaxel, combined with
      mesylate Apatinib and PD-1 monoclonal antibody, explore the effectiveness and safety of this
      three-drug combination regimen for the second-line and above treatment of advanced gastric
      cancer, in order to provide a better late-line treatment plan for patients with advanced
      gastric cancer.
    

Detailed description: 
      This study is a prospective, single-center, single-arm phase II clinical study, which aims to
      explore the efficacy of PD-1 antibody combined with apatinib combined with chemotherapy as a
      second-line and above regimen in the treatment of advanced gastric cancer.The enrolled
      patients were patients with advanced inoperable gastric cancer or gastroesophageal junction
      adenocarcinoma who had advanced first-line fluorouracil combined with platinum or advanced
      second-line paclitaxel and irinotecan, with an ECOG PS of 0-1. Treatment plan: PD-1 antibody:
      200mg intravenous drip every 3 weeks; Apatinib 250mg/day; Chemotherapy: Irinotecan 150mg/m2,
      intravenous drip every 2 weeks, or Paclitaxel 150mg/m2, intravenous drip, once every 3 weeks.
      An imaging evaluation is performed every 6-8 weeks. Monitor blood routine, blood
      biochemistry, electrocardiogram, urine routine, thyroid function, heart function according to
      clinical routine, and record adverse events. Primary observational endpoints: objective
      effective rate (ORR), progression-free survival time (PFS), secondary observational
      endpoints: overall survival time (OS), disease control rate (DCR) and safety, and dynamic
      monitoring of serum biomolecular markers for exploration study .
    

Intervention name(s): PD-1 antibody, paclitaxel or irinotecan, Apatinib mesylate
Intervention type(s): Drug
Intervention description(s): PD-1 antibody 200mg intravenous drip every 3 weeks; Apatinib 250mg/day; Chemotherapy: Irinotecan 150mg/m2, intravenous drip every 2 weeks, or Paclitaxel 150mg/m2, intravenous drip, once every 3 weeks.
Other intervention name(s): PD-1 antibody, chemotherapy,Apatinib
Intervention MeSH terms: Paclitaxel; Irinotecan; Apatinib; Antibodies; Immunoglobulins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gastric cancer; second-line treatment; chemotherapy; Apatinib mesylate; immunotherapy; PD-1 antibody
Study Of AVANDAMET® With Or Without Insulin In Type II Diabetes Mellitus Patients. AVANDAMET® is a Registered Trademark of the GSK Group of Companies.
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was designed to test the safety and efficacy (how well it works) of AVANDAMET in
      combination with insulin in improving the control of blood sugar when compared with taking
      insulin on its own. AVANDAMET capsules contain a fixed dose of AVANDIA and metformin. Both
      AVANDIA and metformin are medicines which are individually licensed for the treatment of type
      II diabetes mellitus. Because they act in different ways, it is thought that combining them
      may give an increased benefit of treating diabetes and reducing blood sugar.
    


Intervention name(s): Rosiglitazone/metformin
Intervention type(s): Drug
Intervention MeSH terms: Metformin; Rosiglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: AVANDAMET insulin type 2 diabetes
A Phase IIb Study for ALX-0061 Monotherapy in Subjects With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is:

      - To assess the efficacy and safety of dose regimens of ALX-0061 monotherapy administered
      subcutaneously (s.c.) to subjects with active rheumatoid arthritis (RA).

      The secondary objectives of this study are:

        -  To assess the effects of ALX-0061 on quality of life, the pharmacokinetics (PK),
           pharmacodynamics (PD), and immunogenicity of ALX-0061 and to explore potential dose
           regimens for ALX-0061 monotherapy, based on safety and efficacy, for further clinical
           development.

        -  To obtain parallel descriptive information concerning the efficacy and safety of
           tocilizumab (TCZ) s.c. in the same clinical trial RA population.
    


Intervention name(s): ALX-0061; Placebo; Tocilizumab
Intervention type(s): Biological; Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Recovery After Fast Track THA / TKA
Condition: Hip and Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Observational

Summary: 
      The development and implementation of "fast-track" principles in total knee and hip
      arthroplasty have resulted in early recovery and rehabilitation alongside a reduced length of
      hospital stay. This without a concomitant increase in morbidity or readmissions for medical
      or surgical complications and with reduced mortality. However, only little is known about
      function in the subacute period after arthroplasty, and there is a need for further data on
      physical and psychological functioning following discharge from hospital.This to ensure, that
      the positive results from the perioperative setting are carried forward in the subacute
      phase.
    

Detailed description: 
      Data will be published in three papers:

        1. "Physical function and related factors following discharge from THA and TKA" Luna IE,
           Kehlet H, Aasvang EK.

        2. "Postoperative hypoxemia following fast-track hip and knee arthroplasty" Luna IE, Kehlet
           H, Aasvang EK.

        3. "Cognitive dysfunction after fast-track hip- and knee arthroplasty - prevalence and
           related factors". Luna IE, Kehlet H, Aasvang EK.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with hip or knee osteoarthritis referred for total joint arthroplasty.
THRA_hematologic Variables
Condition: Avascular Necrosis of Hip
MeSH terms: Necrosis
Study type: Observational

Summary: 
      Total hip replacement arthroplasty is a surgery having intra- and postoperative substantial
      blood loss. The investigators will investigate the relationship between the various
      hematologic variables and postoperative bleeding volume.
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        patients diagosed with avascular necrosis of hip and undergoing total hip replacement
        arthroplasty
nTMS for Motor Mapping of Rolandic Lesions
Condition: Glioma; Brain Metastases
MeSH terms: Neoplasm Metastasis; Brain Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To compare presurgical motor mapping by navigated transcranial magnetic stimulation for
      surgery (nTMS) of rolandic lesions to surgery with mapping without implementing these data
      into neuronavigation as control.

      Primary objective: Permanently new postoperative deficit is lower when the preoperative motor
      mapping is available to the surgeon
    

Detailed description: 
      Experimental intervention:

      presurgical motor mapping by navigated transcranial magnetic stimulation and fusion with
      intraoperative neuronavigation

      Control intervention:

      presurgical motor mapping by navigated transcranial magnetic stimulation without access of
      the surgeon to this data Follow-up per patient: 6 months Duration of intervention per
      patient: 45 minutes
    

Intervention name(s): nTMS data available for the surgeon; nTMS data not available for the surgeon
Intervention type(s): Procedure; Procedure
Intervention description(s): the preoperatively acquired map of the motor cortex by nTMS will be available for the surgeon; the preoperatively acquired map of the motor cortex by nTMS will not be available for the surgeon
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: preoperative Mapping
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: glioma; brain metastases; nTMS