bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Compare PK, PD and Safety of UI058 and UIC202004 in Healthy Subjects
Condition: GERD
Study type: Interventional
Phase: Phase 1

Summary: 
      A Study to compare pharmacokinetics, pharmacodynamics and safety of UI058 and UIC202004 in
      healthy subjects
    


Intervention name(s): administration of UI058; administration of UIC202004
Intervention type(s): Drug; Drug
Intervention description(s): Test; Reference
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Clinical Trial of Acamprosate for Treatment of Methamphetamine Addiction
Condition: Methamphetamine Dependence, Treatment Seeking
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This clinical trial will compare 10 week treatment with acamprosate (2 gr/day) versus
      placebo, combined with weekly abstinence oriented individual counseling, in methamphetamine
      dependent patients, 72 subjects will be enrolled, with an interim analysis scheduled after 36
      enrolled. Primary outcome is methamphetamine absitience over the 10 week treatment period,
      and the last 2 weeks of treatment. Abstinence is defined on a weekly basis as no urine
      positive of methamphetamine (or amphetamine) and self-report of not use for the 7 day period.
      Secondary measures include treatment retention, drug craving, mood, and safety.
    


Intervention name(s): Acamprosate; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2 gr/day (333 mg, TID); matching placebo
Other intervention name(s): Campral
Intervention MeSH terms: Acamprosate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: methamphetamine, crystal, treatment
Non-drug Study to Evaluate the Suitability of Neurocognitive Tests and Functioning Scales for the Measurement of Cognitive and Functioning Changes in Children With Down Syndrome
Condition: Down Syndrome
MeSH terms: Down Syndrome; Syndrome
Study type: Observational

Summary: 
      The aim of this study is to assess the suitability of selected scales (floor/ceiling effects,
      variability, test-retest reliability) to measure cognitive function in children with Down
      syndrome over 6 months, and to evaluate the influence of covariates such as age, gender or
      language on these neurocognitive scales.
    


Intervention name(s): No Intervention
Intervention type(s): Other
Intervention description(s): No intervention was administered in this study
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male and female children, 6 to 11 years of age inclusive, with diagnosis of Down syndrome.
The Efficacy of Extract of Allium Cepae, Allantoin and Heparin in Patients With Proven Scar Development
Condition: Cicatrix
MeSH terms: Cicatrix
Study type: Interventional

Summary: 
      To investigate the efficacy of prophylactic use of a topical gel containing extract of allium
      cepae, allantoin and heparin after surgical removal of the primary cesarean scar in the
      second cesarean section.
    

Detailed description: 
      120 patients who are admitted for the second cesarean delivery, not taking prophylactic
      medication after the first cesarean section, whose scar development and measurements are
      taken will be included in the study. First caesarean section scars will be removed surgically
      for all patients. 60 out of 120 patients (treatment group) will use prophylactic topical scar
      gel 2 times in a day, and remaining 60 patients (control group )won't use. The efficacy of
      the drug will be evaluated by taking strict measurements of the incision and POSAS (The
      Patient and Observer Scar Assessment Scale) and Vancouver Scales at 6.12 and 24 weeks.

      Steps;

        1. Observation of the primary cesarean scar by taking scar measurements and using Vancouver
           and POSAS scales.

        2. Surgical removal of the primary cesarean scar in the second cesarean section.

        3. 24 weeks topical application of gel containing extract of allium cepae, allantoin and
           heparin(only treatment group).

        4. Observation of the skin incision at 6,12 and 24 weeks by taking scar measurements with
           using Vancouver and POSAS scales.
    

Intervention name(s): extract of allium cepae, allantoin and heparin; Scar excision
Intervention type(s): Drug; Procedure
Intervention description(s): prophylactic use of a topical gel containing extract of allium cepae, allantoin and heparin two times in a day after second c-section; Scar excision in second c-section
Other intervention name(s): Contractubex
Intervention MeSH terms: Heparin; Allantoin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: scar prevention; sectio; extract of allium cepae; allantoin; heparin
Immediate and Long-term Induction of Incretin Release by Artificial Sweeteners 2
Condition: Diabetes; Pre-diabetes
MeSH terms: Diabetes Mellitus; Prediabetic State
Study type: Interventional

Summary: 
      Epidemiological data suggest, that not only sugar-based, but also artificially sweetened soft
      drinks may play a role in the development of diabetes.

      Recent studies in animals and humans have shown, that artificial sweeteners (AS) influence
      metabolic responses after glucose ingestion, possibly alter the intestinal microbiome and
      even modulate incretin release.

      Data on human subjects are sparse and controversial, especially in a long-term manner. We
      therefore conduct a cross-over study to assess metabolic response to sweetened vs.
      non-sweetened soft drinks, which are consumed over a period of 4 weeks.
    

Detailed description: 
      Epidemiological data suggest, that not only sugar-based, but also artificially sweetened soft
      drinks may play a role in the development of diabetes.

      Recent studies in animals and humans have shown, that artificial sweeteners (AS) influence
      metabolic responses after glucose ingestion, possibly alter the intestinal microbiome and
      even modulate incretin release.

      Data on human subjects are sparse and controversial, especially in a long-term manner. We
      therefore conduct a cross-over study to assess metabolic response to sweetened vs.
      non-sweetened soft drinks, which are consumed over a period of 4 weeks. Metabolic assessment
      will be based on oral glucose tolerance tests.
    

Intervention name(s): custom-made soft drink
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: incretin release
Safety and Efficacy of Eribullin or Eribulin Combined With Anlotinib in Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Eribulin is the promising agent for late-line metastatic breast cancer patients. The aim of
      this Phase II, double-arm, open-label and prospective clinical trial is to assess the
      efficacy and safety of Eribullin or Eribulin combined with Anlotinib in patients with
      metastatic breast cancer
    

Detailed description: 
      The aim of the double-arm, open-label, phase II clinical trial is to assess efficacy and
      safety of Eribulin or Eribulin combined with Anlotinib in metastatic breast cancers. The
      investigator hypothesize that both Eribulin and Eribulin combined with Anlotinib may be an
      effective alternative treatment for metastatic breast cancers. In addition, Eribulin combined
      with Anlotinib might be able to improve the treatment response and progression-free survival.
    

Intervention name(s): Eribulin Mesylate; Anlotinib
Intervention type(s): Drug; Drug
Intervention description(s): Eribulin mesylate injection is performed on Day 1 and Day 8 of each treatment cycle (21 days per cycle). Patients were treated for six cycles, except disease progression (PD) or treatment stop for other reasons, such as severe adverse effects.; 12 mg Anlotinib is administered for continuous 14 days in 21 day cycles. Patients received Anlotinib untill disease progression.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Tocilizumab in Chinese Participants With Systemic Juvenile Idiopathic Arthritis (sJIA)
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 4

Summary: 
      This Phase IV, multicenter, single-arm, open-label study will evaluate the efficacy and
      safety of tocilizumab in Chinese participants with sJIA with persistent activity and an
      inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs) and steroid therapy.
    


Intervention name(s): Tocilizumab; NSAIDs; CSs; MTX
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tocilizumab will be administered as per the schedule specified in the arm description.; Participants may receive NSAIDs up to the maximum recommended stable daily dose. Study protocol does not enforce any particular NSAID.; Participants may receive CSs at a stable dose of 30 milligrams per day (mg/day) or 0.5 milligrams per kilogram per day (mg/kg/day), whichever is less. Study protocol does not enforce any particular CS.; Participants may receive MTX at a stable dose of less than or equal to (</=) 20 milligrams per square meter (mg/m^2).
Other intervention name(s): RO4877533
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Supplementary Role of Non-invasive Imaging to Routine Clinical Practice in Suspected Non-ST-elevation Myocardial Infarction
Condition: Chest Pain; Myocardial Infarction; Acute Coronary Syndrome; Coronary Artery Disease; Myocardial Ischemia
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Myocardial Infarction; Acute Coronary Syndrome; Non-ST Elevated Myocardial Infarction; Infarction; Ischemia; Chest Pain
Study type: Interventional

Summary: 
      Approximately half of patients with acute chest pain, a very common reason for emergency
      department visits worldwide, have a cardiac cause. Two-thirds of patients with a cardiac
      cause are eventually diagnosed with a so-called non-ST-elevation myocardial infarction. The
      diagnosis of non-ST-elevation myocardial infarction is based on a combination of symptoms,
      electrocardiographic changes, and increased serum cardiac specific biomarkers (high-sensitive
      troponin T). Although being very sensitive of myocardial injury, increased high-sensitive
      troponin T levels are not specific for myocardial infarction. Invasive coronary angiography
      is still the reference standard for coronary imaging in suspected non-ST-elevation myocardial
      infarction. This study investigates whether non-invasive imaging early in the diagnostic
      process (computed tomography angiography (CTA) or cardiovascular magnetic resonance imaging
      (CMR)) can prevent unnecessary invasive coronary angiography. For this, patients will be
      randomly assigned to either one of three strategies: 1) routine clinical care and computed
      tomography angiography early in the diagnostic process, 2) routine clinical care and
      cardiovascular magnetic resonance imaging early in the diagnostic process, or 3) routine
      clinical care without non-invasive imaging early in the diagnostic process.
    


Intervention name(s): Cardiovascular Magnetic Resonance Imaging; Computed Tomography Angiography
Intervention type(s): Other; Other
Intervention description(s): Routine clinical care plus cardiovascular magnetic resonance imaging early in the diagnostic process; Routine clinical care plus computed tomography angiography early in the diagnostic process
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Myocardial infarction; Randomized Controlled Trial; Magnetic Resonance Imaging; Coronary Angiography; Tomography, X-Ray Computed; Mortality; Complications; Quality of Life; Cost-Benefit Analysis
Comparison of Total, Salivary and Calculated Free Cortisol Levels in Patients With Severe Sepsis
Condition: Severe Sepsis
MeSH terms: Sepsis; Toxemia
Study type: Observational

Summary: 
      Background: The purpose of the present study was to compare serum total cortisol (STC),
      salivary cortisol (SaC) and calculated free cortisol (cFC) levels at the baseline and after
      the ACTH stimulation test, in patients with severe sepsis (SS) and to determine the
      suitability of SaC and cFC levels instead of STC for the diagnosis of adrenal insufficiency
      in patients with SS.

      Methods: Thirty patients with SS (15 men, and 15 women) were compared with 16 healthy
      controls. Low dose ACTH stimulation test (1 µg) was performed on the first, 7th and 28th days
      of diagnosis of SS. STC and SaC levels were measured during ACTH stimulation test.
    

Detailed description: 
      More than 90% of circulating cortisol is predominantly bound to cortisol binding globulin
      (CBG), but also albumin. Thus, in the presence of both hypoalbuminemia and decreased CBG
      levels, the ratio of bound to free cortisol levels can be altered. In this situation,
      measurement of FC becomes more important. Direct FC measurement is time consuming and
      non-automated. Thus, some indirect methods to determine FC levels had been introduced. The
      Coolens' method may be practical to determine FC, it estimates FC levels from STC and CBG
      levels. In patients with CI, the synthesis of CBG and albumin is reduced leading to
      overestimation of adrenal insufficiency if we only use STC levels. Since some studies
      demonstrated that salivary cortisol (SaC) reflect free or unbound plasma cortisol levels,
      this method is used more often in clinical studies. STC and SaC levels at baseline and after
      ACTH stimulation had been used in some studies in patients with critical illness.

      The aim of the present study was to compare STC, SaC and calculated free cortisol (cFC)
      levels at baseline and after the ACTH stimulation test in patients with SS and determine the
      suitability of SaC and cFC levels instead of STC for the diagnosis of adrenal insufficiency
      in patients with SS. And secondary aims of this study was to compare these parameters in
      patients with SS with healthy controls and check their effects on survival status of the
      patients.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Thirthy patients with severe sepsis (15 men, and 15 women), and 16 (8 men and 8 women)
        healthy controls
      
Keywords: hypothalamo pituitary adrenal axis
Safety, Tolerability and Pharmacokinetics of Injectable PEG-Irinotecan in Patients With Malignant Solid Tumor
Condition: Solid Tumor
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this clinical trial is to evaluate the safety and tolerability of injectable
      PEG-Irinotecan in patients with malignant solid tumors
    

Detailed description: 
      This study is a multicenter, open labeled, positive controlled, single, -combined, with
      multiple dose escalation trial.

      The trial consists of 6 drug dose groups, which are 50mg/m2, 75mg/m2, 100mg/m2, 125mg/m2,
      150mg/m2 and 180mg/m2 respectively. At each testing dose group, one patient will be treated
      with HCl-Irinotecan (CPT-11), at dose level of 175mg/m2.

      The initial dose of 50mg /m2 will be administered once. Starting from the 75mg/m2 dose group,
      each patient will be given testing drug at least twice. During first and second drug
      administration, blood samples will be collected for PK characteristics analysis. Patients
      will be evaluated after every two rounds of drug delivery and preliminary efficacy of testing
      compound will be determined as PD, SD, CR etc.
    

Intervention name(s): JK-1201I
Intervention type(s): Drug
Intervention description(s): malignant solid tumor that has been confirmed by histopathology and/or cytology
Other intervention name(s): CPT-11
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: This study is a multicenter, open labled, positive controled, single, -combined, with multiple dose escalation trial.
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Clinical Investigation of the Vision-R800 Device.
Condition: Myopia; Hyperopia; Astigmatism; Presbyopia
MeSH terms: Astigmatism; Presbyopia; Hyperopia
Study type: Interventional
Phase: Phase 4

Summary: 
      Randomized, bilateral, cross-over dispensing study of a standard and VR800 refraction and
      associated spectacle lenses.
    


Intervention name(s): Vision R-800 Phoropter; Standard Phoropter
Intervention type(s): Device; Device
Intervention description(s): Refraction utilizing the Vision R-800 Phoropter with resulting glasses; Refraction utilizing the standard phoropter with resulting glasses
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Efficacy of Leg Casts With Heel Off-loaded in Children
Condition: Orthopedic Disorders
MeSH terms: Musculoskeletal Diseases
Study type: Interventional

Summary: 
      Assess whether by placing a "custom made" splint with heel in the immediate postoperative
      period until removal of the cast, the rate of pain, the number of healthcare interventions to
      maintain the off-loaded heel position and number of pressure sores in children wearing lower
      limb plaster casts is reduced.
    


Intervention name(s): custom made splint; standard off-load plaster cast
Intervention type(s): Device; Other
Intervention description(s): Splints have been made by wrapping synthetic bandages around a leg-foot manufactured splint padded at the heel to off-load the heel. When the desired shape has been obtained, the splint is opened and the manufactured device is removed, thus obtaining a device that is used under the casts of lower limbs.; To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Bioequivalence of Adapalene Topical Gel in Patients With Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to evaluate the efficacy and safety of the test formulation
      of adapalene gel 0.1% (PLIVA Research & Development Ltd.) as compared to the already marketed
      formulation, Differin® (adapalene 0.1%) topical gel (Galderma Laboratories) in patients with
      acne vulgaris.
    

Detailed description: 
      Criteria for Evaluation: FDA Bioequivalence Criteria for Comparative Clinical Endpoint
      Studies.

      Statistical Methods: FDA Bioequivalence Statistical Methods for Comparative Clinical Endpoint
      Studies.
    

Intervention name(s): Adapalene; Differin®; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.1% Topical Gel; 0.1% Topical Gel; Gel Base
Other intervention name(s): Adapalene
Intervention MeSH terms: Adapalene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Keywords: Bioequivalence; Acne Vulgaris
A Clinical Trial of Dantrolene Sodium in Pediatric and Adult Patients With Wolfram Syndrome
Condition: Wolfram Syndrome; Diabetes Mellitus; Optic Nerve Atrophy; Ataxia
MeSH terms: Wolfram Syndrome; Ataxia; Optic Atrophy; Diabetes Mellitus; Syndrome; Atrophy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Wolfram syndrome is a rare genetic disorder characterized by juvenile-onset diabetes
      mellitus, diabetes insipidus, optic nerve atrophy, hearing loss, and neurodegeneration. The
      purpose of this study is to assess the safety and tolerability of dantrolene sodium in
      patients with Wolfram syndrome. In addition, we will assess the efficacy of dantrolene sodium
      on the cardinal manifestations of Wolfram syndrome, including visual acuity, remaining beta
      cell functions, and neurological functions.

      There is a screening period up to 56 days, a 6-month treatment period with an optional
      extension phase up to 24 months, and a 4-week safety follow-up period. Study assessments
      include medical & medication history, physical exams, neurological exams, eye exams,
      endocrine exams, vital signs, height, weight, electrocardiograms, blood and urine tests,
      pregnancy test if applicable, and questionnaires.
    


Intervention name(s): dantrolene sodium
Intervention type(s): Drug
Intervention description(s): The purpose of this study is to assess the safety and tolerability of dantrolene sodium in patients with Wolfram syndrome. In addition, we will assess the efficacy of dantrolene sodium on the cardinal manifestations of Wolfram syndrome, including visual acuity, remaining beta cell functions, and neurological functions.
There is a screening period up to 56 days, a 6-month treatment period with an optional extension phase up to 24 months, and a 4-week safety follow-up period. Study assessments include medical & medication history, physical exams, neurological exams, eye exams, endocrine exams, vital signs, height, weight, electrocardiograms, blood and urine tests, pregnancy test if applicable, and questionnaires.
Intervention MeSH terms: Dantrolene
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Wolfram syndrome; Diabetes Mellitus; Optic Nerve Atrophy; Ataxia; Endoplasmic Reticulum Stress