bioihbjkbjnl/mcl2 huggingface dataset:
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Montelukast Sodium 10mg Tablet Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      Objective:

      Primary objective of the present study was to compare the single dose bioavailability of
      Torrent's Montelukast Sodium 10 mg tablet and Innovator's(Merck)Singulair 10 mg tablet.
      Dosing periods were separated by a washout period during fed study.

      Study Design:

      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence
      Study
    


Intervention name(s): Torrent's Montelukast Sodium Tablets 10 mg
Intervention type(s): Drug
Intervention MeSH terms: Montelukast
Allocation: Randomized
Primary purpose: Treatment
DCB-DM101 in Healthy Volunteers and for Type 2 Diabetes Mellitus Patients
Condition: Type2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      An Open-Label Phase I Study to Assess the Safety and Tolerability Profile of Three Escalating
      Doses of DCB-DM101 in Healthy Volunteers and Optimum Dose of DCB-DM101 as Add-on Treatment in
      Type 2 Diabetes Mellitus (T2DM) Patients
    

Detailed description: 
      This is a single center, open-label, phase-I study consisting of two stages: Stage 1 will be
      dose-escalation study to assess the safety and tolerability profile of three escalating doses
      of DCB-DM101 in healthy volunteers and Stage 2 will apply optimum dose of DCB-DM101 as add-on
      treatment in T2DM patients. In Stage 2, patients are allowed to receive metformin for T2DM
      for routine use of which the dosing regimen should not be adjusted. No other
      medication/treatments for T2DM are allowed. Stage 2 can only be proceeded upon the approval
      of health authority in Taiwan. After determining the optimal dose for Stage 2, the reasons
      for determining such dose together with relevant supporting data should be submitted to
      health authority in Taiwan for review and to determine whether stage 2 can be proceeded and
      which dose should be employed for stage 2.
    

Intervention name(s): DCB-DM101
Intervention type(s): Drug
Intervention description(s): determination of optimal dose for Stage 2
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Constraints Induced Movement Therapy Versus Mirror Therapy in Children With Hemiplegic Cerebral Palsy
Condition: Cerebral Palsy; Hemiplegic Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      The aim of this study is to find Effects of constraints induced movement therapy (CIMT)
      versus mirror therapy (MT) on hand dexterity and grip strength in children with hemiplegic
      cerebral palsy.
    

Detailed description: 
      Although quite number of research has been done on effects of CIMT and mirror therapy but
      most of the studies included stroke population. There was no literature on comparative effect
      of both CIMT and Mirror therapy in children with hemiplegic cerebral palsy. This study will
      be covering specifically cerebral palsy children to have better treatment techniques to be
      introduced in therapeutic programs of hemiplegic cerebral palsy children.
    

Intervention name(s): Constraint Induced Movement Therapy (CIMT); Mirror Therapy (MT)
Intervention type(s): Other; Other
Intervention description(s): I will apply CIMT on effected hand to observe the hand dexterity and grip strength; I will apply Mirror Therapy on effected hand to obeserve the hand dexterity and grip strength
Other intervention name(s): CIMT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cerebral palsy; constraints induced movement therapy; mirror therapy
Evaluation of Patient Reported Outcomes in RRMS Patients Candidates for MS Therapy Change and Transitioned to Fingolimod 0.5 mg (EPOC)
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient
      Outcomes, Safety and Tolerability of (fingolimod) 0.5 mg/day in Patients with Relapsing
      Remitting Multiple Sclerosis who are candidates for MS therapy change from Previous Disease
      Modifying Therapy.
    


Intervention name(s): Fingolimod; Interferon beta - 1a (IFN); Glatiramer acetate (GA)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.5 mg orally once a day; 44 mcg subcutaneously three times a week; 20 mg subcutaneously once a day
Other intervention name(s): Gilenya; Rebif; Copaxone
Intervention MeSH terms: Interferons; Interferon-beta; Glatiramer Acetate; Fingolimod Hydrochloride; (T,G)-A-L
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Relapsing Remitting Multiple Sclerosis (RRMS); Fingolimod; Disease Modifying Therapy (DMT); TSQM-9
The Effect of Calorie Deprivation on Adipose Tissue Distribution
Condition: Healthy
Study type: Interventional

Summary: 
      In this study, we will be studying the effects of acute calorie deprivation (a 10-day fast)
      on bone marrow fat, other fat stores and bone parameters. We will be measuring changes in
      bone marrow fat using magnetic resonance spectroscopy and will use MRI to measure
      subcutaneous and visceral fat depots. Our hypothesis is that levels of bone marrow fat will
      increase after an acute fast.
    


Intervention name(s): Fasting
Intervention type(s): Behavioral
Intervention description(s): Ten day fast
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Healthy subjects; Fasting; Weight loss
Allogeneic Adipose Tissue-Derived Mesenchymal Stem Cells (GXCPC1) for Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of the investigators study was to investigate the safety and efficacy of allogeneic
      ADSCs for the clinical treatment of knee osteoarthritis.
    


Intervention name(s): GXCPC1; HA
Intervention type(s): Drug; Device
Intervention description(s): The dose regimen is one single intra-articular injection of GXCPC1 containing 6.7×10^6 or 4×10^7 ADSCs in 3 mL saline. (allogeneic injection); Hya Joint Plus synovial fluid supplement 3mL
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Carotid B-Mode Ultrasound Study to Compare Anti-Atherosclerotic Effect of Torcetrpib/Atorvastatin to Atorvastatin Alone.
Condition: Hypercholesterolemia, Familial; Hyperlipidemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia; Hyperlipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      The Torcetrapib project was terminated on December 2, 2006 due to safety findings.

      To look at ultrasound images taken in the carotid arteries and to look at various lipids in
      the blood of people with heterozygous familial hypercholesterolemia
    

Detailed description: 
      For additional information please call: 1-800-718-1021
    

Intervention name(s): torcetrapib/atorvastatin; atorvastatin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Atorvastatin; Torcetrapib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Effect of BIA 5-1058 400 mg on the Steady State Pharmacokinetics of Sildenafil
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is:

        -  To assess the effect of BIA 5 1058 400 mg on the pharmacokinetics (PK) of sildenafil.

        -  To assess the effect of sildenafil on the PK of BIA 5-1058.
    

Detailed description: 
      This study was an open label, three period, fixed sequence study in healthy male and female
      subjects performed under fasting conditions at a single study center.

      The study comprised:

        -  Screening during Days -28 to -2 (both inclusive).

        -  Three treatment periods separated by a washout period of at least 10 days.

      Duration of Treatment:

      The duration of participation for each subject was approximately 2 months and 3 weeks
      (including the screening period).
    

Intervention name(s): BIA 5-1058; Sildenafil
Intervention type(s): Drug; Drug
Intervention description(s): Oral BIA 5-1058 (Zamicastat) 100 mg tablets; Oral Sildenafil ( Revatio) 20 mg film coated tablets
Other intervention name(s): Zamicastat; Revatio
Intervention MeSH terms: Sildenafil Citrate; Zamicastat
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Relative Bioavailability Study of Revatio for the Crushed Tablets, Extemporaneously Prepared Formulation, and the Intact Tablets at 20 mg Dose in Healthy Volunteers
Condition: Healthy
MeSH terms: Crush Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a randomized, open-label, 3-treatment, 3-period, crossover, single-dose study in
      healthy subjects. Eighteen (18) subjects will complete the study; dropouts may be replaced at
      the discretion of the sponsor. Three treatments are:

      Treatment A: Revatio 20 mg intact tablet. Treatment B: Revatio 20 mg crushed tablet mixed
      with apple sauce. Treatment C: Revatio 20 mg extemporaneously prepared suspension (EP). Blood
      samples for the analysis of sildenafil in plasma will be obtained pre-dose and up to 14 hours
      post dose in each period. Tolerability and safety will be assessed by reported adverse events
      during each study period.
    


Intervention name(s): Revatio; Revatio; Revatio
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Three treatments as described in study design, single dose, three way crossover. The treatment duration will be minimum 3 days for each subject.; Three treatments as described in study design, single dose, three way crossover. The treatment duration will be minimum 3 days for each subject.; Three treatments as described in study design, single dose, three way crossover. The treatment duration will be minimum 3 days for each subject.
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bioavailability; Revatio; Healthy Volunteers
The Effect of Frequency and Duration of Breaks in Sitting Time on Metabolic Cardiovascular Risk Factors
Condition: Sedentary Lifestyle; Overweight and Obesity; Metabolic Disease
MeSH terms: Overweight; Metabolic Diseases
Study type: Interventional

Summary: 
      The primary aim of this study is to investigate the acute effect of the frequency and
      duration of breaks in sitting time on the metabolic risk factor profile.
    

Detailed description: 
      Fifteen (n=15) sedentary adult overweight males will be included in the study. All
      participants will undergo the four interventions in a randomized cross-over design. Wash out
      between intervention will be minimum four days.

      Control (CON): Participants will be sedentary. Sedentary time will be spent sitting in a
      chair, restricted to sedentary behaviors (working on a computer, reading, watching TV, etc.),
      with a target MET below 1.5 (i.e. 1.5 times REE). Participants will only be allowed to stand
      or walk to go to the toilet.

      Breaker: Participants will be breaking up prolonged sitting with 2 min intervals of low
      intensity walking.

      Intermediate: Participants will be breaking up prolonged sitting with 6 min intervals of low
      intensity walking

      Prolonger: Participants will be breaking up prolonged sitting with 12 min intervals of low
      intensity walking

      All interventions will be matched for total physical activity as well as sitting. Thus, we
      aim for the active interventions to be iso-caloric.
    

Intervention name(s): Control; Breaker; Prolonger; Intermediate
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Control intervention; Short breaks of physical activity; longer breaks of physical activity; Intermediate breaks of physical activity
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Exercise; Breaking prolonged sitting; physical activity
Study to Evaluate the Safety and Immunogenicity of Combined Hepatitis A/B Vaccine With MenACWY-CRM Conjugate Vaccine
Condition: Meningococcal Disease; Meningococcal Meningitis; Hepatitis A; Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Meningococcal Infections; Meningitis, Meningococcal; Hepatitis; Meningitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study compares the safety and immunogenicity profile of combined hepatitis A/B vaccine
      given alone or concomitantly with MenACWY-CRM to healthy adults.
    


Intervention name(s): MenACWY-CRM; Combined inactivated hepatitis A & recombinant hepatitis B; Recombinant hepatitis B vaccine; Inactivated hepatitis A vaccine
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Novartis meningococcal ACWY conjugate vaccine will be administered intramuscularly (IM) on day 1.; Combined inactivated hepatitis A and recombinant hepatitis B vaccine will be administered by IM on days 1, 8 & 29 for subjects unprimed with hepatitis A and B; and a single booster injection on day 1 for primed subjects.; Recombinant hepatitis B vaccine will be administered intramuscularly on days 8 and 29; Inactivated hepatitis A will be administered intramuscularly on days 8 and 29.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: meningococcal; conjugate; vaccine; adults
Pilot Study of Head Cooling in Preterm Infants With Hypoxic Ischemic Encephalopathy
Condition: Hypoxic Ischemic Encephalopathy
MeSH terms: Brain Diseases; Brain Ischemia; Hypoxia-Ischemia, Brain; Ischemia; Hypoxia
Study type: Interventional
Phase: Phase 1

Summary: 
      The hypothesis is that premature infants' can have enough cooling applied to cool their brain
      to decrease CNS injury without cooling their body.
    

Detailed description: 
      Hypoxic ischemic encephalopathy (HIE) is a potentially devastating disease of the newborn
      central nervous system (CNS) . Portions of the CNS are deprived of oxygen and blood flow for
      a period of time which may lead to permanent brain injury manifested as cerebral palsy as
      well as cognitive defects. Until recently no treatment has been shown to be effective for
      preventing brain damage, even though it has been demonstrated that the damage is progressive
      and that there is a window of opportunity to arrest some of the evolving brain injury.
      However, in May of 2007 the FDA approved the first device specifically designed to ameliorate
      brain damage in term babies with HIE. This head cooling device which was studied here at
      Vanderbilt under IRB protocol 990129 Brain Cooling for the treatment of perinatal hypoxic
      ischemic encephalopathy. We thus have eight years of experience of using this device in term
      infants. The results of the initial trial demonstrated a successful reduction of HIE induced
      brain injury from 66% in control infants to 55% in treated babies. There were no significant
      risks to the application of this device in term babies who are kept cool for 72 hours after
      experiencing an acute HIE event. The initial trials were limited to term babies because of
      concern that premature infants would be more at risk for hypothermia induced problems such as
      hypoglycemia,and coagulopathy. The concern about hypothermia in preterm infants remains a
      limiting consideration for doing whole body cooling in this population. We propose to apply
      the cooling cap to the heads of preterm infants who have experienced a significant HIE injury
      but maintain their body temperature in the normal range (36.1-37° C rectally). Infants will
      be cooled for up to 72 hours and will be tracked till discharge. Although this is a
      feasibility study, the participants will also be followed-up at 6, 12 and 24 months of age.
    

Intervention name(s): Olympic Cool Cap
Intervention type(s): Device
Intervention description(s): Olympic Cool Cap will be applied to infants 32-35 weeks gestation who meet criteria for HIE.
Other intervention name(s): Selective Head Cooling
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypoxic ischemic encephalopathy; HIE; Neonatal encephalopathy; Cooling; hypothermia
Raltitrexed and Paclitaxel for Gastric or Gastroesophageal Junction Adenocarcinoma
Condition: Gastric Cancer; Gastroesophageal Junction Adenocarcinoma
MeSH terms: Adenocarcinoma; Stomach Neoplasms; Esophageal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a single-arm clinical trial.The purpose of this study is to evaluate the efficacy and
      safety of Raltitrexed and Paclitaxel as second-line chemotherapy for patients with
      unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma .The primary
      endpoint of this study is objective response rate.The secondary endpoint of this study is
      safety,progression-free survival and overall survival.
    

Detailed description: 
      Raltitrexed is an antifolate thymidylate synthase inhibitor that has shown efficacy and good
      safety profile in the treatment of colorectal cancer. To our knowledge, there has been no
      study published with the Raltitrexed and Paclitaxel regimen as second-line chemotherapy for
      patients with unresectable or metastatic gastric or gastroesophageal junction
      adenocarcinoma.The aim of our study was to evaluate the efficacy, safety and survival of this
      regimen in patients with unresectable or metastatic gastric or gastroesophageal junction
      adenocarcinoma.
    

Intervention name(s): Raltitrexed; Paclitaxel
Intervention type(s): Drug; Drug
Intervention description(s): Raltitrexed:3mg/m2,iv,d1, Every 3 weeks; Paclitaxel:80mg/m2,iv,d1,d8, Every 3 weeks
Other intervention name(s): RTX
Intervention MeSH terms: Paclitaxel; Raltitrexed
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Raltitrexed; Paclitaxel; chemotherapy; Gastric cancer; Gastroesophageal Junction Adenocarcinoma
Mold Sensitization Associated Severe Asthma Exacerbation
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      Mold sensitization is associated with severe asthma exacerbation.
    

Detailed description: 
      Mold sensitization has been reported to be one of the factors that is associated with severe
      asthma exacerbation (SAE). The objective is to identify the factors that are associated with
      SAE in asthmatic children particularly mold sensitization.
    

Intervention name(s): Skin test
Intervention type(s): Other
Intervention description(s): Demographic data review, Disease severity evaluation, Treatment evaluation and Skin prick test for 16 common aeroallergens
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Asthmatic children aged 1-15 years old from Pediatric Allergy and Immunology division
        devided in to 2 groups: 1. hospitalized due to severe asthma exacerbation in a preceding
        year and 2. without severe asthma exacerbation in a preceding year
      
Keywords: severe asthma exacerbation; Mold sensitization
Increasing Uptake of Colorectal Cancer Screening in Ontario
Condition: Colorectal Disorders
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The investigators hope to determine whether the addition of an FOBT kit and educational
      materials to a second mailed invitation compared to a second mailed invitation alone
      increases use of appropriate screening tests (FOBT for average risk or colonoscopy if
      increased risk) by eligible persons within 6 months of the second mailing in:
      (1)Non-responders to an initial mailed CRC screening invitation from their family physician
      and, (2)Those who responded to the initial mailed CRC screening invitation and are due for
      repeat screening (i.e., "recall" patients). In addition, the investigators will also explore
      the impact of the investigators intervention in likely under-screened groups such as those
      living in more remote areas of the province and those with low socio-economic status as well
      as assessing the cost-effectiveness of this strategy.
    


Intervention name(s): FOBT kit; Mailed invitation
Intervention type(s): Other; Other
Intervention description(s): Mailed FOBT kit with educational materials and mailed CRC screening invitation on behalf of family physician.; Mailed CRC screening invitation alone on behalf of family physician.
Other intervention name(s): Mailed FOBT kit; Mailed invitation alone
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Screening
Keywords: colorectal cancer; screening; fecal occult blood testing; mailed invitation
CSD170304: Study to Assess Nicotine Uptake in Smokers From Electronic and Combustible Cigarettes
Condition: Smoking
Study type: Interventional

Summary: 
      To determine the rate and amount of nicotine uptake with 10-minute ad libitum use of five
      different marketed electronic cigarettes, or one combustible cigarette (CC). Furthermore, to
      measure overall product liking by subjects to assess potential willingness to seek out the
      Electronic Cigarette (EC) again in the future.
    

Detailed description: 
      This will be a single-center, randomized, open-label, parallel study during which up to 210
      healthy adult subjects, consisting of 35 subjects per product group, will be enrolled.
      Subjects will be evaluated for plasma nicotine uptake, as well as overall product liking. The
      study will involve the use of five different marketed ECs or one CC in tobacco consumers who
      are exclusive smokers (i.e., naïve EC users) or dual users of cigarettes and ECs (i.e.,
      intermittent EC users).
    

Intervention name(s): FT210771; FT210751; 6T30134157764; G41A7C071; M011161212; FT21002
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): An electronic cigarette; An electronic cigarette; An electronic cigarette; An electronic cigarette; An electronic cigarette; A combustible cigarette
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other