bioihbjkbjnl/mcl2 huggingface dataset:
HEC53856 Phase 1 Study - Single and Multiple Oral Dosing in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety, tolerability and pharmacokinetics of HEC53856 after single or
      multiple oral administration, as well as the food effect on the pharmacokinetics, in healthy
      non-elderly subjects.
    

Detailed description: 
      This is a Phase I, Single Center, Randomized, Double-blind, Placebo-controlled Study to
      Evaluate the Tolerability and Pharmacokinetics of HEC53856 capsule in Healthy Adult Subjects.
      The study consists of three parts, single dose ascending, multiple dose ascending and food
      effect testing. Within each part participants will be randomized to either drug or placebo.
    

Intervention name(s): HEC53856; placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral administration; oral administration
Other intervention name(s): HEC53856 capsule; HEC53856 matching placebo capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
SENSIMED Triggerfish Safety and Tolerability
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional

Summary: 
      The purpose of this investigation is to study the safety and tolerability of SENSIMED
      Triggerfish, a soft contact lens-based device intended to continuously record relative
      changes in intraocular pressure (IOP). The investigation enrols glaucoma patients and
      glaucoma suspects. All subjects receive two 24-hour recording sessions with the device in an
      ambulatory setting and at weekly interval. The level of discomfort in the study eye after 24
      hours and side effects are the main endpoints of the investigation.
    


Intervention name(s): SENSIMED Triggerfish
Intervention type(s): Device
Intervention description(s): Soft contact lens-based device intended for continuous recording of relative changes in IOP
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Prospective Randomized Study of Brain Protection During Aortic Arch Replacement
Condition: Aneurysm of Aortic Arch
MeSH terms: Aneurysm
Study type: Interventional

Summary: 
      The purpose of this research study is to evaluate two standard approaches of supplying blood
      and oxygen to your brain during open heart surgery.
    

Detailed description: 
      The purpose of the clinical trial is to assess the best method of protecting the brain during
      long periods of circulatory arrest. The significance of this project will be to determine
      which method of brain protection (1) retrograde brain perfusion or (2) perfusion of the right
      subclavian artery with antegrade perfusion of the brain protects against brain injury after
      total arch replacement. Thus reducing the risk of stroke or neurocognitive deficits in
      patients undergoing this critical surgical procedure.
    

Intervention name(s): Retrograde brain perfusion; Antegrade brain perfusion
Intervention type(s): Procedure; Procedure
Intervention description(s): observational; observational
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of CPP-ACP Paste on Dental Caries in Primary Teeth
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if adding daily application of CPP-ACP containing
      paste for one year is superior to regular fluoride tooth brushing in preventing dental caries
      in high caries risk Thai preschool children.
    

Detailed description: 
      The 6th National Oral Health Survey in Thailand 2006-2007 reported that 3-year-old children
      who resided in central part have the highest dental caries prevalence of 69.8 percent with
      dmft affecting 3.63 teeth on average. Fluoride is widely accepted as the most effective tool
      to caries prevention for initial caries lesions. Current best practice recommends twice-daily
      tooth brushing with fluoride toothpaste for dentate children.

      CPP-ACP can bolster the effects of fluoridated toothpaste alone to prevent caries.Currently,
      almost all clinical trials have investigated the effectiveness of CPP-ACP containing products
      in dental caries prevention and enhancing remineralization of initial carious lesion in the
      permanent dentition of young adolescents. There are no clinical studies of the effect of a
      CPP-ACP containing product to prevent dental caries in the primary dentition of young
      children.
    

Intervention name(s): 10 % w/v CPP-ACP paste; the paste without CPP-ACP
Intervention type(s): Drug; Drug
Intervention description(s): Apply once a day at school by school teacher, following fluoride toothbrushing after lunch; Apply once a day at school by school teacher, following fluoride toothbrushing after lunch.
Other intervention name(s): Tooth Mousse
Intervention MeSH terms: 6-chloro-2-(1-piperazinyl)pyrazine; Caseins
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Caries detection/diagnosis/prevention; Preventive Dentistry; Casien Phosphopeptide; Remineralization; Clinical trial
Sorafenib Plus Vitamin K1 Versus Sorafenib in Advanced Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional

Summary: 
      60 patients of radiological, biopsy proven advanced HCC (Hepatocellular carcinoma) patient
      will be randomized into two groups. Cases group will receive Sorafenib plus vitamin K and
      control group will receive Sorafenib plus placebo
    


Intervention name(s): Sorafenib 400mg twice daily + intravenous infusion ofVit K1; Sorafenib 400 mg twice daily + Intravenousinfusion of placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sorafenib 400mg twice daily + intravenous infusion ofVit K1 50 mg/day with daily increase of dose by 50 mg for 6 days, followed by oral Vitamin K1 20mg twice daily for 3month; Sorafenib 400 mg twice daily + Intravenousinfusion ofplacebo daily for 6 days, followed by oral placebo twice daily x 3month
Intervention MeSH terms: Sorafenib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Vaginal Progesterone Versus Progesterone in Oil in Donor Egg Recipient In Vitro Fertilization Cycles Utilizing Vitrified Donor Eggs
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to evaluate both pharmaceutical therapy and advanced treatment
      techniques for infertile patients requiring in-vitro fertilization utilizing donor eggs.
    

Detailed description: 
      The primary objective of this study is to evaluate the clinical pregnancy rate of micronized
      progesterone (Endometrin, Ferring Pharmaceuticals) compared to progesterone in oil injections
      in in-vitro fertilization (IVF) donor egg recipients. The secondary objective is to evaluate
      the effectiveness of freezing/vitrification of donor eggs. Effectiveness of vitrification
      will be evaluated by egg thaw/survival, fertilization, and implantation rates.
    

Intervention name(s): Endometrin; Progesterone in Oil
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg per vagina TID; 50 mg IM injection daily
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: In-Vitro Fertilization; Donor Egg IVF
A Drug Interaction Study of SPD503 and Concerta Administered Alone and In Combination in Normal Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a drug-drug interaction study; the purpose of this study is to examine the
      pharmacokinetics (levels of drug in the blood) of SPD503 (guanfacine hydrochloride) and
      Concerta (methylphenidate HCl) when given alone, and in combination.
    


Intervention name(s): SPD503; Concerta; SPD503 + Concerta
Intervention type(s): Drug; Drug; Drug
Intervention description(s): SPD503 (guanfacine hydrochloride) extended-release 4 mg orally administered tablets; CONCERTA (methylphenidate HCl) extended-release 36 mg orally administered tablets.; SPD503 4 mg + CONCERTA 36 mg orally administered tablets (taken together).
Other intervention name(s): Intuniv
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Healthy volunteers
Niños Sanos, Familia Sana - A Multi-Intervention Program to Prevent Childhood Obesity in Mexican-Heritage Children in Rural California
Condition: Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      Obesity and overweight are health problems resulting from the interaction of predisposing
      genes with environmental, economic and social stimuli, in conjunction with excess caloric
      intake throughout growth from childhood to adulthood. Evidence suggests that a major barrier
      in controlling overweight/obesity is the complex interrelation of these factors, making
      single-approach interventions less likely to succeed than integrated, multi-faceted
      approaches. The proposed project aims to deliver a multi-faceted behavioral intervention
      developed over the past 18 months by a university-community /school-based collaborative. This
      project aims to provide new knowledge about the effectiveness of interventions designed
      specifically to achieve successful weight management among Mexican-origin children ages 3-8,
      and identify associated mediating factors. Deliverables will include community-based,
      collaborative and sustainable tools to support weight-management goals in this demographic.
      UC Davis and UC Cooperative Extension (UCCE) faculty form the investigator team,
      collaborating on key decision points with the project community in California's Central
      Valley. The investigators hypothesize that the identified mediating factors will increase
      fruit and vegetable consumption. The investigators also hypothesize an increase in the
      intensity and frequency of physical activity among children in the intervention group.
    


Intervention name(s): Ninos Sanos Familia Sana
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: child obesity; Mexican-American; Nutrition education; Intervention
Buprenorphine in Acute Renal Colic Pain Management
Condition: Acute Pain Management; Renal Colic
MeSH terms: Colic; Acute Pain; Renal Colic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether sublingual Buprenorphine is as effective as
      Iv Morphine sulfate on pain control of the patients with acute renal colic in the emergency
      department.
    


Intervention name(s): Buprenorphine; Morphine
Intervention type(s): Drug; Drug
Intervention description(s): 2 mg sublingual tablet; 0.1 mg/kg IV morphine
Intervention MeSH terms: Morphine; Buprenorphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Bioequivalence Trial of Concor AM® vs Bisoprolol and Amlodipine in Chinese Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, open-label, randomized, 2-period, 2-sequence, crossover study to
      demonstrate bioequivalence (BE) between the bisoprolol-amlodipine fixed-dose-combination
      (FDC) tablet (investigational product) and bisoprolol and amlodipine tablets administered
      concomitantly (comparators) given as a single oral dose in fasting and fed state.
    


Intervention name(s): Bisoprolol-Amlodipine FDC; Bisoprolol; Amlodipine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants received a single oral dose of 5 milligram(mg)/5 mg bisoprolol-amlodipine FDC tablet (Concor AM®) either on Day 1 or Day 15 under fasting or fed conditions.; Participants received 5 mg bisoprolol tablet as a single oral dose either on Day 1 or Day 15 under fasting or fed conditions.; Participants received 5 mg amlodipine tablet as a single oral dose either on Day 1 or Day 15 under fasting or fed conditions.
Other intervention name(s): Concor AM®
Intervention MeSH terms: Amlodipine; Bisoprolol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Concor AM®; Concor®; Norvasc®; Bisoprolol; Amlodipine; Bisoprolol-Amlodipine fixed dose combination; Chinese Participants
Interferon Alfa With or Without Interleukin-2 and Fluorouracil in Treating Patients With Advanced Metastatic Kidney Cancer
Condition: Kidney Cancer
MeSH terms: Kidney Neoplasms; Carcinoma, Renal Cell
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Interferon alfa may interfere with the growth of tumor cells. Interleukin-2 may
      stimulate a person's white blood cells to kill tumor cells. Drugs used in chemotherapy use
      different ways to stop tumor cells from dividing so they stop growing or die. Combining
      interferon alfa with interleukin-2 and fluorouracil may kill more tumor cells. It is not yet
      known whether interferon alfa is more effective with or without interleukin-2 and
      fluorouracil in treating metastatic kidney cancer.

      PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa combined
      with interleukin-2 and fluorouracil to that of interferon alfa alone in treating patients who
      have advanced metastatic kidney cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare progression-free and overall survival of patients with advanced metastatic renal
           carcinoma treated with interferon alfa with or without interleukin-2 and fluorouracil.

        -  Compare the toxicity of these regimens in these patients.

        -  Assess the quality of life of patients treated with these regimens.

      OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of
      2 treatment arms.

        -  Arm I (Interferon alfa monotherapy): Patients receive interferon alfa subcutaneously
           (SC) on days 1, 3, and 5. Treatment continues weekly for at least 9 weeks in the absence
           of disease progression or unacceptable toxicity.

        -  Arm II (Interferon alfa, interleukin-2, and fluorouracil combination therapy): Patients
           receive interferon alfa SC on day 1 of weeks 1 and 4 and days 1, 3, and 5 of weeks 2, 3,
           5, 6, 7, and 8. Patients also receive interleukin-2 SC twice daily on days 3-5 of weeks
           1 and 4 and once daily on days 1, 3, and 5 of weeks 2 and 3. Patients then receive
           fluorouracil IV on day 1 of weeks 5-8. Treatment repeats every 10 weeks for up to 2
           courses in the absence of disease progression or unacceptable toxicity.

      Quality of life is assessed at baseline, at 9, 19, and 26 weeks, and then at 8 months.

      Patients are followed at 8, 10, and 12 months, every 4 months for 1 year, and then every 6
      months thereafter.

      PROJECTED ACCRUAL: A total of 670 patients (335 per treatment arm) will be accrued for this
      study.
    

Intervention name(s): aldesleukin; recombinant interferon alfa; fluorouracil
Intervention type(s): Biological; Biological; Drug
Intervention MeSH terms: Interferons; Interferon-alpha; Aldesleukin; Fluorouracil
Allocation: Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IV renal cell cancer
Effect of Ultrasound Guided Embryo Transfer on Pregnancy Rates
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      To assess the effect of transabdominal ultrasound guided embryo transfer on the pregnancy
      rates versus clinical touch technique
    

Detailed description: 
      A total of 90 patients undergoing treatment with ICSI were divided into 2 groups: group 1 (45
      patients), had ultrasound guided embryo transfer and group 2 (45 patients), underwent embryo
      transfer using the clinical touch technique
    

Intervention name(s): GnRh, HMG, HCG, Progesterone
Intervention type(s): Drug
Intervention description(s): GnRh analogue (0.05 mg/day), HMG (150-300 iu/day), HCG (5000 iu/day), Progesterone (100 mg/day)
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Embryo transfer, transabdominal ultrasound, IVF, ICSI
A Study of Aprepitant (MK-0869) in Pediatric Participants Undergoing Surgery (MK-0869-148)
Condition: Postoperative Nausea and Vomiting
MeSH terms: Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 1

Summary: 
      This two part study will determine the appropriate dosing regimen of aprepitant for the
      prevention of postoperative nausea and vomiting (PONV) in pediatric participants 6 months to
      17 years of age, by assessing pharmacokinetic parameters and monitoring safety and
      tolerability of administered doses. Part I will be an open label investigation of a single
      dose of aprepitant measuring pharmacokinetics at specified time points up to 48 hours after
      aprepitant dosing. Part II will be a double blind trial of participants randomized to receive
      either aprepitant or ondansetron.
    


Intervention name(s): Aprepitant; Ondansetron
Intervention type(s): Drug; Drug
Intervention description(s): Aprepitant administered orally or intraveously.; Ondansetron administered intravenously.
Other intervention name(s): Emend; Zofran
Intervention MeSH terms: Ondansetron; Aprepitant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Clinical Investigation of Non Invasive Fat Reduction
Condition: Subcutaneous Fat
Study type: Interventional

Summary: 
      The purpose of this study is to compare non invasive treatments using a YAG and Didode Laser
      to reduce the volume of fat.
    


Intervention name(s): Diode Laser; YAG laser
Intervention type(s): Device; Device
Intervention description(s): Diode Laser for treatment of subcutaneous fat; YAG laser for treatment of subcutaneous fat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Personalized Asthma Care Team
Condition: Asthma; Sleep Disordered Breathing; Obesity
MeSH terms: Asthma; Sleep Apnea Syndromes
Study type: Observational

Summary: 
      "Individualized health care" refers to the development of strategies for disease management
      and health promotion that are informed by specific data on genetics and physiological
      processes that uniquely determine each person's health profile and potential responsiveness
      to interventions or susceptibility to environmental exposures.

      Asthma, an inflammatory disorder of the airway, appears to be determined by multiple
      interacting genetic and environmental factors. Such risk factors include allergic responses,
      small airways, excess body weight, specific properties of airway smooth muscle, airway and
      generalized metabolic and inflammatory homeostasis, and exposures to environmental irritants,
      allergens, and psychosocial stressors. To date, asthma treatment strategies have been guided
      by "severity" guidelines rather than by characteristics of the child's specific phenotype (a
      child's underlying allergic tendency, extent of airway inflammation and airway smooth muscle
      dysfunction, or underlying obesity and metabolic perturbations). The growing availability of
      new classes of asthma medications that more directly target specific pathophysiological
      derangements will require accessing data on each child's asthma risk profiles to optimize
      selection of medications and other interventions that most specifically address the
      underlying pathophysiology while minimizing adverse treatment side effects.

      The investigators propose to develop a model program for collecting relevant clinical
      information and genetic data on a high risk group of asthmatic children, including data on
      common co-morbidities, specifically obesity and sleep disorders; use this information to
      develop a comprehensive model database for characterizing children according to their health
      profiles; and use this characterization to initiate targeted interventions, while continuing
      long term follow up of these children to determine differential responsiveness to
      medications.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All children seen at the pediatric pulmonology department with a diagnosis of asthma or
        symptoms of persistent wheeze, unexplained by an etiology other than asthma, ages 4 to 18
        years will be recruited.