bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Insulin Aspart in Subjects With Type 1 or Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial is conducted in Asia. The aim of this trial is to compare the efficacy of
      postprandial plasma glucose of two treatment regimens in Chinese subjects.
    


Intervention name(s): soluble human insulin; insulin aspart; insulin NPH
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Isophane Insulin, Human; Insulin, Isophane; Isophane insulin, beef
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Acne Treatment With Active Patches Which Contains Azelaic Acid, Citric Acid,Salicylic Acid and 2% Ascorbic Acid
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study was to demonstrate the effect of short treatment with active OPLON
      patches on Acne.
    

Detailed description: 
      Patients with Acne Vulgaris were treated overnight with active patches. Effect is observed at
      the end of the treatment and 24 hours later.
    

Intervention name(s): OPLON active patch; Sham patch
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety & Immunogenicity of Pneumococcal Vaccine 2189242A in Children Aged 12-23 Months at the Time of First Vaccination
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the safety, reactogenicity and immunogenicity of different
      formulations of GSK Biologicals' pneumococcal vaccine 2189242A when administered alone or in
      combination with the 10-valent pneumococcal conjugate vaccine (GSK1024850A vaccine) as a
      2-dose primary vaccination course followed by a booster dose in healthy children aged 12-23
      months at the time of first vaccination. Considering that febrile reactions are frequently
      observed following pneumococcal vaccination, usually co-administered with other routine
      paediatric vaccines, the primary study objective will focus on evaluating the increase in
      grade 3 fever (i.e. rectal temperature >40.0°C).
    


Intervention name(s): Pneumococcal vaccine GSK2189242A (formulation 1); Pneumococcal vaccine GSK2189242A (formulation 2); Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 3); Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 4); Pneumococcal vaccine GSK1024850A
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Three doses will be administered intramuscularly, at Month 0, 2 and 6.; Three doses will be administered intramuscularly, at Month 0, 2 and 6; Three doses will be administered intramuscularly, at Month 0, 2 and 6; Three doses will be administered intramuscularly, at Month 0, 2 and 6; Three doses will be administered intramuscularly, at Month 0, 2 and 6
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: immunogenicity; toddlers; Pneumococcal vaccine; Haemophilus influenzae; safety; Streptococcus pneumoniae; Streptococcus Pneumoniae Vaccines
Efficacy of the Nanodropper Device on Pupillary Dilation
Condition: Dilation
MeSH terms: Mydriasis; Dilatation, Pathologic
Study type: Interventional

Summary: 
      Prescription eye drop bottles elute drops that exceed the capacity of the human eye by five
      times. This study describes performing in clinic dilation using a novel solution for
      combating medical waste with Nanodropper, an eye drop bottle adapter that creates smaller eye
      drops.
    


Intervention name(s): Nanodropper; Standard Eye Dropper
Intervention type(s): Device; Device
Intervention description(s): Device used for administering eye drops; Standard Eye Dropper used for administering eye drops
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
WISE ARIC: Retinal Photography in Women With Chest Pain
Condition: Chest Pain
MeSH terms: Chest Pain
Study type: Observational

Summary: 
      The purposes of this study are:

        -  To correlate the severity of retinal arteriolar narrowing and other microvascular
           changes, as determined from retinal photographs and video imaging, to measures of
           coronary microvascular function in women evaluated for chest pain.

        -  To evaluate measures of vascular compliance with applanation tonometry and
           photoplethysmography using a nasal alar probe.
    

Detailed description: 
      Women who meet study eligibility criteria and provide written informed consent will have a
      baseline physical exam, including measurements of heart rate, blood pressure, weight. Medical
      history will be updated, specifically cardiovascular events (hospitalizations, procedures)
      since last contact and current medications. Patients will be scheduled for retinal
      photography. Those who are currently being screened and qualify for EWISE or other ancillary
      studies will have retinal photography scheduled as close to the index CFR as possible and
      prior to receiving randomized therapy.

      The retinal photography will follow a standardized written protocol.

      For the second protocol, 100 patients will be scheduled for an appointment in the Eye clinic
      where they will meet the Women's Ischemic Syndrome Evaluation (WISE)/Atherosclerosis Risk in
      Communities (ARIC) staff and complete the baseline information and have a brief physical
      examination. They will then have provocative testing completed with retinal imaging.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women who participated in or are being screened for the WISE or EWISE or any ancillary
        studies
      
Keywords: women; chest pain; microvascular dysfunction; retinal photography; Retinal vascular function
26 Weeks' Dietary Supplementation With DHA- and EPA-enriched Oils on Cerebral Blood Flow in Healthy Adults
Condition: Neurovascular Coupling
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effects of EPA- and DHA-enriched omega-3
      polyunsaturated fatty acid dietary supplements on cerebral blood flow during a series of
      cognitive, mathematical subtraction tasks and subjective ratings of task difficulty before
      and after 26 weeks of supplementation
    


Intervention name(s): Olive oil Placebo; EPA-rich; DHA-rich
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): olive oil; EPA-rich omega-3 oil; DHA-rich omega-3 oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB3 in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the pharmacokinetics, safety, tolerability and
      immunogenicity of SB3 and Herceptin® (EU sourced Herceptin® and US sourced Herceptin®) in
      healthy male subjects.
    


Intervention name(s): SB3; EU sourced Herceptin®; US sourced Herceptin®
Intervention type(s): Biological; Biological; Biological
Intervention MeSH terms: Trastuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Pharmacokinetics
A Study Evaluating the Safety and Efficacy of Topical BPR277 for the Treatment of Atopic Dermatitis and Netherton Syndrome
Condition: Healthy Volunteers; Atopic Dermatitis; Netherton Syndrome
MeSH terms: Dermatitis, Atopic; Netherton Syndrome; Dermatitis; Eczema; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is divided in 3 parts, starting with the safety assessment of BPR277 ointment in
      Healthy volunteers (Part 1). If found to be well tolerated in Part 1, BPR277 ointment will be
      assessed in two different patients groups to evaluate safety and efficacy in atopic
      dermatitis (Part 2) and in Netherton syndrome (Part 3).
    


Intervention name(s): BPR277 ointment (controlled application); Placebo (Vehicle); BPR277 ointment; Placebo (Vehicle); BPR277; Placebo (Vehicle)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Atopic dermatitis; Eczema; Skin Diseases, Eczematous; Netherton syndrome; Skin Diseases, Genetic; BPR277
Intracavitary Fluid and Position of C-section-scar
Condition: Fluid Uterus
Study type: Observational

Summary: 
      Does the presence of intracavitary fluid during hormonal stimulation for IVF depends on the
      position of C-section-scar ?
    

Detailed description: 
      To evaluate the correlation between the presence of intracavitary fluid and the position of
      the C-section-scar in relation to the uterine fundus and the inner cervical os.

      To this end, we will compare measured variables, in patients with intracavitary fluid and
      without intracavitary fluid.
    

Intervention name(s): ultrasound,transvaginal scan
Intervention type(s): Diagnostic Test
Intervention description(s): The presence of fluid in the uterine cavity during hormonal stimulation.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing IVF treatment in the IVI Middle East Clinic Abu Dhabi and Dubai, due to
        secondary infertility and delivery with at least one previous C-section.
The Effect of Probiotics on Constipation, and Intestinal Microflora in Children With Functional Constipation
Condition: Functional Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the differences of fecal microflora between constipated and non-constipated
      healthy children, and evaluate the efficacy of probiotics in reducing symptoms of
      constipation and the influence of intestinal microflora in children with functional
      constipation.
    

Detailed description: 
      The investigators performed a monocentric, prospective, randomized controlled trial including
      120 pediatric patients (aged 6 months - 10 years old) with functional constipation and 30
      healthy age-matched healthy children as control. The investigators shall evaluate the
      children according to the Rome III Diagnostic Criteria for functional constipation.

      The 120 enrolled patients are randomized in to two groups: Group A receiving magnesium oxide
      and probiotics (MIYAIRI-BM), Group B receiving only magnesium oxide. Each patient is assigned
      the evaluation constipation symptoms and detection of microflora (beneficial and harmful
      bacteria) in fecal samples at the enrollment, 4 weeks, and 12 weeks. Patients who take less
      than 80% of the appropriate dose of medications are withdrawn from the study. All patients
      included in the study will be given informed oral consent before entering the study.

      The data of the fecal microflora evaluated in 60 healthy children are used as control.
    

Intervention name(s): Magnesium Oxide; MIYAIRI-BM
Intervention type(s): Drug; Drug
Intervention description(s): Magnesium oxide 250 mg per day for children with weight < 15 kg, 500 mg per day for weight <15-30 kg, and 1000 mg per day for weight > 30 kg; MIYAIRI-BM 1 g (1package) per day for children with weight < 15 kg, 2g per day for weight 15-30 kg, and 3g per day for weight > 30 kg
Other intervention name(s): MgO; Clostridium Butyricum MIYAIRI
Intervention MeSH terms: Magnesium Oxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluating Perioperative Dexamethasone and the Risk of Bleeding in Tonsillectomy
Condition: Post-operative Hemorrhage
MeSH terms: Hemorrhage; Blood Loss, Surgical; Postoperative Hemorrhage
Study type: Interventional

Summary: 
      Tonsillectomy (removal of the tonsils) is a very common surgery in children. Bleeding after
      tonsillectomy is one of the risks of this surgery and can be more dangerous in children since
      they have less blood volume than adults. In order to improve recovery after tonsillectomy,
      steroids (medication that is a strong anti-inflammatory) are often given during the surgery.
      Recently, a study showed steroids given at the time of tonsillectomy increase the risk of
      bleeding significantly over children who did not receive steroids. This finding has raised
      concerns in the Ear, Nose, and Throat (ENT) community since most ENT's use steroids during
      tonsillectomy in children. The investigators look to explore this question further.

      To answer the question of whether perioperative steroid administration significantly affects
      the rate of post-tonsillectomy bleeding, the investigators propose to test the following
      hypotheses in a prospective, randomized, blinded placebo-controlled trial: dexamethasone does
      not cause an increase in post-operative bleeding rate in tonsillectomy.
    

Detailed description: 
      Detailed description is entered above
    

Intervention name(s): Dexamethasone
Intervention type(s): Drug
Intervention description(s): 0.5mg/kg (max dose 20mg)
Other intervention name(s): Decadron
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Efficacy of a Toothpaste to Reduce Sensitivity
Condition: Dentin Hypersensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional
Phase: Phase 3

Summary: 
      Hypersensitivity
    


Intervention name(s): Triclosan, Silicon dioxide, fluoride; Triclosan, fluoride
Intervention type(s): Drug; Drug
Intervention description(s): Brush twice daily; Brush twice daily
Intervention MeSH terms: Silicon; Triclosan; Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Multi-Colored Placido Disk Viability
Condition: Dry Eye; Sjogren's Disease; Healthy
MeSH terms: Sjogren's Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to show that the multi-colored Placido Disk set-up can get
      reliable data over long time periods.
    


Intervention name(s): Multi-colored Placido disk imaging
Intervention type(s): Procedure
Intervention description(s): The multi-colored Placido disk instrument records the tear surface using video imaging.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: volunteers
A Clinical Trial to Evaluate the Immunogenicity and Safety of PPV23 Vaccine Revaccinations in the Elderly
Condition: Vaccination
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the the immunogenicity and safety of 23-valent pneumococcal polysaccharide
      vaccine revaccinations in the elderly
    

Detailed description: 
      1. Antibody double growth rate in 28-40 days after immunization;

        2. Antibody GMC level in 28-40days after immunization;

        3. Incidence of adverse reactions in 0-30days.
    

Intervention name(s): 23-valent pneumococcal polysaccharide vaccine
Intervention type(s): Biological
Intervention description(s): The study group and the control group were injected with a dose of 23-valent pneumococcal polysaccharide vaccine. One month later, blood was collected and serum was separated.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Study group is PPV23 revaccination and control group PPV23-vaccination.
Masking: None (Open Label)
Primary purpose: Prevention
A New Oral Treatment For Type II Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a 24-week study investigating the safety and efficacy of several dosages of a
      potential new oral medicine for Type II diabetes mellitus.
    

Detailed description: 
      A 12-Week, Parallel-Group, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Dose
      Ranging Study to Evaluate the Efficacy, Safety and Tolerability of GW823093, Administered
      Orally, Once Daily, as Monotherapy in Subjects With Type 2 Diabetes Mellitus followed by a
      12-week Active Treatment Extension
    

Intervention name(s): Placebo; DEN 2.5 mg; DEN 7.5 mg; DEN 15 mg; DEN 30 mg; DEN 45 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Placebo capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.; DEN 2.5 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.; DEN 7.5 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.; DEN 15 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.; DEN 30 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.; DEN 45 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads.
Other intervention name(s): GW823093 2.5 mg; GW823093 7.5 mg; GW823093 15 mg; GW823093 30 mg; GW823093 45 mg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: NIDDM
Capecitabine and Oxaliplatin in Treating Older Patients With Metastatic Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in
      different ways to stop the growth of tumor cells, either by killing the cells or by stopping
      them from dividing.

      PURPOSE: This phase II trial is studying how well giving capecitabine together with
      oxaliplatin works in treating older patients with metastatic colorectal cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the efficacy of capecitabine and oxaliplatin as first-line treatment, as
           defined by stabilization or improvement by 1 point on Katz's Activities of Daily Living
           scale, in older patients with metastatic colorectal adenocarcinoma.

      Secondary

        -  Determine the toxicity of this regimen in these patients.

        -  Determine the percentage of patients who receive the first 3 courses of this regimen (at
           lower doses) and the percentage of patients who receive all 6 courses of this regimen
           (at both lower and higher doses).

        -  Determine efficacy of this regimen, as defined by RECIST criteria, in these patients.

        -  Determine the pharmacokinetics of this regimen in these patients.

      OUTLINE: This is a multicenter, open-label, nonrandomized study.

      Patients receive oral capecitabine* once daily on days 1-14 and oxaliplatin* IV on day 1.
      Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or
      unacceptable toxicity.

      NOTE: *The doses of both capecitabine and oxaliplatin are increased in courses 4-6 in the
      absence of unacceptable toxicity

      PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
    

Intervention name(s): capecitabine; oxaliplatin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Capecitabine; Oxaliplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IV colon cancer; stage IV rectal cancer; adenocarcinoma of the colon; adenocarcinoma of the rectum
Study on Examination of Therapeutic Efficacy and Potential Mechanisms of Yoga Treatment in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      The aim of this study is to examine whether yoga is efficacious as an add-on treatment for
      negative symptoms of schizophrenia in a randomized multi-centric trial and also to examine
      functional brain changes associated with self-reflection after treatment with yoga.
    


Intervention name(s): Yoga arm
Intervention type(s): Behavioral
Intervention description(s): Yoga module developed for patients with Schizophrenia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Yoga; fMRI
Naltrexone Treatment for Alcoholism
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the effectiveness of the medication naltrexone (Revia) for treating
      alcoholism. Individuals will be inpatients for a 2 week period and provide assessments of
      their alcohol withdrawal symptoms, craving, and mood. Following hospital discharge,
      individuals will be assigned randomly to receive naltrexone daily, naltrexone twice a day or
      a placebo. This part of the study will last 12 weeks, with regular measurements of drinking
      level, craving and mood. Assessments will be conducted 6 and 12 months after the beginning of
      the study.
    


Intervention name(s): naltrexone (Revia)
Intervention type(s): Drug
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Primary purpose: Treatment