bioihbjkbjnl/mcl2 huggingface dataset:
Comparison Study of Oxytocin Versus Tranexamic Acid and Etamsylaye Versus Placebo(Saline)
Condition: Blood Loss, Surgical; Blood Loss, Postoperative
MeSH terms: Hemorrhage; Blood Loss, Surgical; Postoperative Hemorrhage
Study type: Interventional

Summary: 
      Comparison Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate Versus Normal Saline
      as Pre-operative Administration.
    

Detailed description: 
      Comparison Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate Versus Normal Saline
      to reduce intra operative bleeding and postoperative bleeding during elective Cesarean
      Delivery.
    

Intervention name(s): Oxytocin
Intervention type(s): Drug
Intervention description(s): trial of reduction of losing blood intra operative or post operative during Cesarean Delivery
Other intervention name(s): Tranexamic acid and Etamsylate
Intervention MeSH terms: Tranexamic Acid; Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: blood loss; cesarean section; oxytocin; tranexamic acid; etamsylate; saline; Intra-operative; Postoperative
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), Food Effect of AMG 357 in Healthy Subjects
Condition: Inflammatory Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to evaluate the safety, tolerability, PK, PD, and food effect of AMG 357 in healthy
      subjects
    


Intervention name(s): AMG 357; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration available in varying dose strength.; Matching placebo to AMG 357 containing no active drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Role of Vitamin D3 and Calcium Supplementation in Attenuating T2DM Severity
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effect of vitamin D3 and calcium
      supplementation in attenuating type 2 diabetes mellitus outcomes in ethnic diverse, diabetic
      patiens.
    

Detailed description: 
      Subjects of this study received a total of 1800 IU vitamin D3 and 720 mg of calcium per day
      for 3 years. The study was conducted in Toronto, Ontario, Canada.
    

Intervention name(s): vitamin D3 and calcium; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 1800 IU vitamin D3 plus 720 mg Calcium; Rice powder pills
Intervention MeSH terms: Vitamin D; Cholecalciferol; Calcium
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: serum calcidiol; T2DM; vitamin D3 supplementation; post-menopausal women; ethnic diverse; calcium supplementation
Strengthening Transplantation Effects of Bone Marrow Mononuclear Cells With Atorvastatin in Myocardial Infarction
Condition: Myocardial Infarction; Stem Cell Transplantation; Angioplasty, Transluminal, Percutaneous Coronary
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 2

Summary: 
      The benefit of current stem cell transplantation therapy for myocardial infarction is limited
      by low survival rate for stem cell. The purpose of this study is to test whether intensive
      Atorvastatin therapy can improve the outcome of patients with impaired left ventricle
      function after myocardial infarction who underwent intracoronary transfer of autologous bone
      marrow cells.
    

Detailed description: 
      The major challenge to a successful stem cell therapy for myocardial infarction is the low
      survival rate of implanted cells in the damaged tissue. Atorvastatin, an HMG-CoA reductase
      inhibitor, has multiple biological activities independent of cholesterol-lowering action.This
      study is performed to find out more information about the strategy with Atorvastatin therapy
      to improve the survival of implanted cells. autologous bone marrow stem cells
      transplantation. Patients between 30 and 80 years of age who receive autologous bone marrow
      stem cell transplant at the Fuwai cardiovascular hospital may be eligible for this study.
      These patients receive autologous bone marrow cells transplantation intracoronary undergoing
      Percutaneous Coronary Intervention with regular or high dose of Atorvastatin treatment. The
      objective evaluations will be performed at baseline and during 12 months follow-up.

      Heart function tests may include the following:

        1. Electrocardiogram (EKG) evaluates the electrical activity of the heart. Electrodes
           placed on the chest transmit information from the heart to a machine.

        2. Echocardiogram (Echo) is an ultrasound test that uses sound waves to create an image of
           the heart and examine the function of the heart chambers and valves.

        3. Gated acquisition scan is a nuclear medicine test that uses a small amount of
           radioactive chemical injected into a vein. A special scanner creates an image of the
           heart for examining the beating motion of the muscle.

        4. MRI evaluates function of the heart chambers the beating motion of the muscle.
    

Intervention name(s): Atorvastatin and mononuclear cells transplantation
Intervention type(s): Drug
Intervention description(s): Routine or intensive dose of Atorvastatin therapy and mononuclear cells transplantation
Other intervention name(s): Statin; Bone marrow stem cells transplantation
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Group-Based Lifestyle Intervention in Measuring Biomarker Levels in Participants at High Risk for Breast Cancer
Condition: Atypical Ductal Breast Hyperplasia; Atypical Lobular Breast Hyperplasia; BRCA1 Mutation Carrier; BRCA2 Mutation Carrier; Ductal Breast Carcinoma in Situ; Lobular Breast Carcinoma in Situ
MeSH terms: Carcinoma; Breast Neoplasms; Carcinoma in Situ; Carcinoma, Ductal, Breast; Breast Carcinoma In Situ; Carcinoma, Intraductal, Noninfiltrating; Carcinoma, Lobular; Hyperplasia
Study type: Interventional

Summary: 
      This randomized clinical trial studies a group-based lifestyle intervention or usual care in
      measuring biomarker levels in participants at high risk for breast cancer. Studying the
      effects that changes to daily eating and exercise habits can have on the body's hormone
      levels and the body's ability to activate proteins may help doctors identify interventions
      for individuals at high risk for breast cancer.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To calculate eligibility rates, participation rates, retention, and adherence within the
      Diet, Exercise and Estrogen Metabolites (DEEM) study.

      II. To determine inter- and intra-person variability of the estrogen-deoxyribonucleic acid
      (DNA) adducts (EDA) biomarkers in participants of the DFS.

      III. To explore the effects of the intervention on percent adiposity and the EDA ratio at the
      end of the 3-month intervention and 6-month follow-up.

      SECONDARY OBJECTIVES:

      I. To explore the effects of the intervention on the DNA damage repair (DDR) biomarker at
      3-months.

      OUTLINE: Participants are randomized to 1 of 2 arms.

      ARM I: Participants take part in weekly 2-hour group counseling sessions for 6 months with
      taper beginning at 3 months. Group sessions include education, group process, and
      experiential learning on the benefits of physical activity, balanced nutrition, and
      mindfulness techniques. Participants set goals for changing their dietary habits with the
      help of a mental health counselor and are also encouraged to exercise 3-4 times per week,
      including experiential group activities such as brisk walking, yoga, Zumba, and group
      fitness.

      ARM II: Participants receive their usual care and are also provided with study materials on
      healthy diet and exercise at the end of the study.

      After completion of study, participants are followed up for 3 months.
    

Intervention name(s): counseling intervention; behavioral dietary intervention; exercise intervention; questionnaire administration; laboratory biomarker analysis
Intervention type(s): Other; Behavioral; Behavioral; Other; Other
Intervention description(s): Take part in weekly group counseling sessions; Set goals for changing dietary habits; Attend group exercise activities; Ancillary studies; Correlative studies
Other intervention name(s): counseling and communications studies
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Uptake to Colorectal Cancer Screening in Familial-risk Population
Condition: Colorectal Cancer; Screening Uptake of Colonoscopy and FIT
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      This is a multicenter, controlled, randomized phase III study to compare participation rate
      with two screening rounds of fecal occult blood test (FIT) versus one-time screening
      colonoscopy in first degree relatives (FDR) of patients diagnosed of colorectal cancer (CRC).

      The hypothesis of the study is that annual FIT uptake and colonoscopy when a positive test is
      higher than that of straightforward colonoscopy. Assuming an uptake of 0.50 for colonoscopy
      and 0.60 for FIT, a Type I error (alpha) of 5% and a power of 90%, 538 FDRs will be necessary
      to include in each group.
    

Detailed description: 
      This is a multicenter, controlled, randomized phase III study to compare participation rate
      with two screening rounds of FIT versus one-time screening colonoscopy in FDR of patients
      diagnosed of CRC.

      The recruitment process will be programmed through the index case, that will be interviewed
      to obtain their CRC family history. FDR will be contacted in order to make an appointment in
      the High-risk CRC Clinic of the participant centers. Randomization will be performed before
      signing the informed consent to avoid selection bias. A researcher will be responsible to
      provide detailed information about the study and getting the informed consent. In case of
      willingness to participate in the study, the FDR will be randomized to one of the following
      arms: A) One-time colonoscopy; B) annual FIT for two screening rounds and a colonoscopy in
      case of a positive FIT (cut-off = 10 μg Hemoglobin/g feces). Screening uptake will be defined
      as the percentage of FDR who participate at least in one of the two FIT screening round in
      the FIT group or who undergo colonoscopy in the other group. Screening uptake will be
      calculated under the assumption of intention to screen analysis.

      The hypothesis of the study is that annual FIT uptake and colonoscopy when a positive test is
      higher than that of straightforward colonoscopy. Assuming an uptake of 0.50 for colonoscopy
      and 0.60 for FIT, a Type I error (alpha) of 5% and a power of 90%, 538 FDRs will be necessary
      to include in each group.
    

Intervention name(s): annual FIT and colonoscopy in case of a positive test; colonoscopy with sedation
Intervention type(s): Procedure; Procedure
Intervention description(s): FIT and colonoscopy in case of a positive test. Annual interval (2 rounds), without diet restriction, 1 stool sample. Positive cut-off 10 mcg Hemoglobin/g feces.; One-time Colonoscopy with sedation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Immunochemical fecal occult blood test; Colonoscopy; Screening uptake; Screening participation; Familiar risk; Colorectal Cancer
Effect of Cholecalciferol Supplementation on Disease Activity and Quality of Life of Systemic Lupus Erythematosus Patients .
Condition: Lupus Erythematosus, Systemic; Cholecalciferol Supplementation; Disease Activity; Quality of Life
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 3

Summary: 
      Increase in the prevalence and survival rates has led to the assessment of disease activity
      and quality of life of SLE patients as targets in treatment. Cholecalciferol supplementation
      was considered as having a role in reducing disease activity and improving quality of
      life.This research was a double blind, randomized, controlled trial was conducted on female
      outpatients aged 18-60 years with SLE, consecutively recruited from September to December
      2021 at Cipto Mangunkusumo Hospital. Sixty subjects who met the research criteria were
      randomized and equally assigned into the cholecalciferol and placebo groups. The study
      outcomes were measured at baseline and after 12 weeks of intervention. we measured he level
      of vitamin D before and after intervention, the disease activity by MEX-SLEDAI score and the
      quality of life by Lupus QoL
    


Intervention name(s): Vitamin D3
Intervention type(s): Drug
Intervention description(s): cholecalciferol tablet, the dose is 5000 international unit /day for 12 weeks
Other intervention name(s): Cholecalciferol
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There are two groups : cholecalciferol group( intervention group) which get cholecalciferol 5000 iu/day for 12 weeks and saccharum lactis group ( placebo group) which get saccharum lactis for 12 weeks
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: lupus erythematosus systemic; cholecalciferol supplementation; Mex-SLEDAI score; Lupus QoL
Ambu® Auragain™ as a Conduit for Intubation in Paediatrics
Condition: Pediatric Endotracheal Intubation
Study type: Interventional

Summary: 
      This study will be conducted as a prospective observational study

      This study will be done in any of the operating theatres of University Malaya Medical Centre

      This study will involve paediatric cases ( ages 3-12 years )posted for elective operations
      which require general anaesthesia with endotracheal intubation

      Ambu Aura Gain will be used as a conduit for intubation
    

Detailed description: 
      All eligible participants will be approached and recruited Informed consent will be obtained
      Induction of general anesthesia will be as per usual standardized method Ambu® Auragain™ will
      be inserted A paediatric flexible endoscope will be used to view the glottis and railroad an
      endotracheal tube into the trachea Placement is confirmed and number of attempts and time
      required for successful intubation is recorded Ambu® Auragain™ will be removed Number of
      attempts and time taken for removal of Ambu® Auragain™ will be recorded Any complications
      will be noted and recorded
    

Intervention name(s): Intubation via AMBU® AURAGAIN™
Intervention type(s): Device
Intervention description(s): Success rate of paediatric intubation through AMBU® AURAGAIN™
Other intervention name(s): AMBU® AURAGAIN™; Supraglottic device
Intervention model: Single Group Assignment
Intervention model description: Prospective observational study All eligible patients will be approached and recruited All patients will be assigned to a single group - the use of AMBU® AURAGAIN™ as a conduit for flexible scope intubation No comparison groups
Masking: None (Open Label)
Primary purpose: Other
Keywords: AMBU® AURAGAIN™; intubation in paediatrics; flexible scope guided intubation; success rate of intubation; glottic view; supraglottic airway intubation; efficacy safety
Chemotherapy Plus Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Solid Tumors
Condition: Unspecified Adult Solid Tumor, Protocol Specific
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining chemotherapy with bone marrow or peripheral stem cell
      transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more
      tumor cells.

      PURPOSE: Phase I trial to study the effectiveness of melphalan and thiotepa plus bone marrow
      or peripheral stem cell transplantation in treating patients who have recurrent or refractory
      solid tumors.
    

Detailed description: 
      OBJECTIVES: I. Determine the maximum tolerated dose of melphalan and thiopeta in patients
      with recurrent or refractory solid tumors. II. Evaluate the overall survival and response
      rate in these patients.

      OUTLINE: This is a dose escalation study. Patients receive cyclophosphamide IV over 1 hour on
      day 1 and paclitaxel IV over 4 or 24 hours on day 2, followed by daily filgrastim (G-CSF)
      subcutaneously beginning on day 3 and continuing through day 7 or until WBCs are greater than
      100,000 cells/mm3. Peripheral blood stem cells (PBSC) or autologous bone marrow is collected
      on days 5-7. At 30-50 days following mobilization, patients receive melphalan IV over 15-60
      minutes on days -5 and -4 and thiotepa IV over 2 hours on days -3 and -2, followed by
      autologous bone marrow transplantation or PBSC infusion on day 0. Sequential dose escalation
      of melphalan is followed by sequential dose escalation of thiotepa. Dose escalation in
      cohorts of 5 patients each continues until the maximum tolerated dose (MTD) is determined.
      The MTD is defined as the dose preceding that at which 2 of 4, 3 of 7, 4 of 11, or 5 of 15
      patients experience dose limiting toxicity. Patients are followed at 60 days and at 12
      months.

      PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4 years.
    

Intervention name(s): filgrastim; cyclophosphamide; melphalan; paclitaxel; thiotepa; autologous bone marrow transplantation; peripheral blood stem cell transplantation
Intervention type(s): Biological; Drug; Drug; Drug; Drug; Procedure; Procedure
Intervention MeSH terms: Paclitaxel; Cyclophosphamide; Melphalan; Thiotepa
Primary purpose: Treatment
Keywords: unspecified adult solid tumor, protocol specific
Efficacy and Safety Study of MYOBLOC® Followed by Open-Label Multiple-Treatment With MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adult Subjects
Condition: Sialorrhea
MeSH terms: Sialorrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy and safety of MYOBLOC in the treatment of Sialorrhea
      (drooling), which can be a symptom of many disease conditions. MYOBLOC will be injected
      directly into the salivary glands. MYOBLOC has been shown in previous trials to safely
      decrease saliva production, thereby demonstrating its potential as a safe and effective
      treatment for troublesome sialorrhea.
    


Intervention name(s): MYOBLOC; PLACEBO
Intervention type(s): Drug; Other
Intervention description(s): MYOBLOC (rimabotulinumtoxinB) Injection, or botulinum toxin type B, is the "B" serotype of botulinum toxin. It is the only commercially available "B" serotype, and also the only available botulinum toxin that does not require reconstitution for use.
Other intervention name(s): rimabotulinumtoxinB, botulinum toxin type B; volume-matched placebo
Intervention MeSH terms: rimabotulinumtoxinB; Botulinum Toxins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sialorrhea; Parkinson's disease; Amyotrophic lateral sclerosis (ALS); stroke; neuroleptics
Efficacy of an Educational School-based Intervention to Reduce Prevalence of Obesity in Childhood-EdAl-2
Condition: Childhood Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      Our hypothesis is that a regular systematic educational intervention in primary school
      improves lifestyle choices and reduces obesity. As such, the aim of the study is to evaluate
      the effects of a 3-year school-based program of lifestyle improvement, including diet and
      physical activity, implemented by university students acting as "health promoting agents"
      (HPA) on the prevalence of obesity.
    

Detailed description: 
      Initial pupil enrollment and continued for 3 years.
    

Intervention name(s): lifestyle counseling
Intervention type(s): Behavioral
Intervention description(s): In 3 academic years, the intervention program consisted of three components:
Classroom practice by HPA to highlight healthy lifestyle habits
Teaching practice by HPA using books designed to include the nutritional objectives
Parental activities included with their children
In each of 12 activities (1 h/activity), the classroom practice consisted of three components:
Experimental development of activities regarding each healthy lifestyle habit
Assessment of activity performed in classroom
An activity developed for use at home
Other intervention name(s): Childhood obesity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effect of Liraglutide on the Beta-cell Responsiveness in Subjects With Type 2 Diabetes Compared to a Healthy Control Group
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in the United States of America (USA). The aim of this trial is to
      assess the effect of NNC 90-1170 on beta-cell responsiveness to increasing blood glucose
      concentrations in subjects with type 2 diabetes.
    


Intervention name(s): liraglutide; placebo
Intervention type(s): Drug; Drug
Intervention description(s): A single dose of 7.5 mcg/kg administered subcutaneously in random order; A single dose administered subcutaneously in random order
Other intervention name(s): NNC 90-1170
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment