bioihbjkbjnl/mcl2 huggingface dataset:
A Study in Korean Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of Denosumab
Condition: Osteoporosis, Postmenopausal
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if denosumab is effective in increasing bone
      mineral density at the lumbar spine in Korean postmenopausal women with osteoporosis.
    


Intervention name(s): denosumab; placebo; open-label denosumab
Intervention type(s): Drug; Drug; Drug
Intervention description(s): double-blind phase: 60mg subcutaneous injection, single dose; double-blind phase: placebo subcutaneous injection, single dose; open-label phase: 60mg subcutaneous injection, single dose
Intervention MeSH terms: Denosumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: denosumab; Republic of Korea; dual energy x-ray absorptiometry
Assessment of Abuse Potential of Cebranopadol in Humans
Condition: Human Abuse Potential
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be conducted to evaluate the abuse potential of single doses of cebranopadol
      as compared with oxycodone, tramadol and matching placebo in recreational drug users.
    

Detailed description: 
      Randomized, single site, double-blind, placebo- and active-controlled, crossover, single oral
      dose, Phase 1 trial, in non dependent recreational opioid users
    

Intervention name(s): Oxycodone 40 mg; Tramadol 600 mg; Placebo; Cebranopadol 600 µg; Cebranopadol 1000 µg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Participants will be administered a single dose of 6 capsules containing oxycodone and placebo in a randomized crossover manner; Participants will be administered a single dose of 6 capsules containing tramadol in a randomized crossover manner; Participants will be administered a single dose of 6 capsules containing placebo in a randomized crossover manner; Participants will be administered a single dose of 6 capsules containing cebranopadol and placebo in a randomized crossover manner; Participants will be administered a single dose of 6 capsules containing cebranopadol and placebo in a randomized crossover manner
Other intervention name(s): Qualification Phase/ Treatment Phase; Qualification Phase/ Treatment Phase; Qualification Phase/ Treatment Phase; Treatment Phase; Treatment Phase
Intervention MeSH terms: Oxycodone; Tramadol
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, single site, double-blind, placebo- and active-controlled, crossover, single oral dose, Phase 1 trial, in non dependent recreational opioid users
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: pain; abuse; opioid
Pico-Salax Versus Poly-Ethylene Glycol for Bowel Cleanout Before Colonoscopy in Children
Condition: Colonoscopy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this trial is to compare patient's satisfaction from Pico-Salax with the
      standard of care, Poly-Ethylene Glycol and electrolyte solution, for bowel cleanout before
      colonoscopy in children, and to compare effectiveness.
    

Detailed description: 
      Good bowel cleanout before colonoscopy is commonly associated with significant discomfort
      that children do not tolerate well. Many pediatric centers in North America use Poly-Ethylene
      Glycol and electrolyte solution (PEG-ELS, Golytely®) for bowel lavage administered in a large
      volume, often causing nausea, vomiting and bloating. This is often poorly tolerated by
      children who usually require the insertion of a nasogastric tube and a day admission.
      Recently, Pico-Salax was approved in Canada for bowel cleanout in children. It is
      administered in two divided doses, each in one cup of water; it is palatable and does not
      have to be given in hospital. However, no controlled study in children compared it with the
      current standard of care. Our preliminary experience and previous literature suggest that it
      is effective and well tolerated. We propose to study whether colon cleanout for colonoscopy
      with Pico-Salax is better tolerated than Golytely in children, by a single blinded randomized
      controlled trial. Positive results of this study will facilitate a better tolerated regimen
      for bowel clean out in children.
    

Intervention name(s): PEG-Lyte®; Pico-Salax®
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pediatrics; Colonoscopy; Bowel cleanout; Poly-Ethylene Glycol; Pico-Salax
Safety and Efficacy of Overnight Closed Loop in Children With Type 1Diabetes Mellitus in Luxembourg
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this study is to validate current algorithms and evaluate safety and efficacy
      of overnight closed loop insulin delivery (FlorenceD2 system) in children with type 1
      diabetes between 6 - 12 years of age in Luxembourg .
    


Intervention name(s): FLORENCED2
Intervention type(s): Device
Intervention description(s): FLORENCED2 device ensures the closed loop between Freestyle Navigator II and the DANA DIABECARE R
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 diabetes mellitus; children; closed loop; cross over; overnight; FLORENCED2; DANA Diabecare R pump; FreeStyle Navigator II; Dexcom G4
A Study of Escalating Doses of Itacitinib Administered Orally in Patients With Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study of itacitinib in patients with chronic plaque psoriasis. This study will
      evaluate safety and efficacy parameters of itacitinib.
    


Intervention name(s): Itacitinib; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Itacitinib administered orally; Placebo administered orally
Other intervention name(s): INCB039110
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
The Role of Chest Electrical Impedance Tomography in the Pediatric Ventilator Weaning
Condition: Ventilator Weaning; Child; Spontaneous Breathing Trial; Electrical Impedance Tomography
MeSH terms: Respiratory Aspiration
Study type: Observational [Patient Registry]

Summary: 
      To correlate the data obtained by Electrical impedance tomography (EIT) during the
      spontaneous breathing trials (SBT) on a T-piece, in children, with failure in the trial and
      Extubation failure.

      Observe if the EIT monitoring will be able to detect the children that will fail earlier than
      the SBT performed alone.

      Method: A cross-sectional, prospective study to explore the potential benefits of monitoring
      with EIT during weaning.
    

Detailed description: 
      Early and successful Extubation is sometimes a difficult combination in children, since the
      criteria for suggesting it are often subjective and poorly defined. Electrical impedance
      tomography (EIT) has been developed and used clinically for more than 30 years. Interest in
      this technology arose from the need to monitor ventilation and pulmonary perfusion at the
      bedside. Because it is a non-invasive and non-radiation technology, EIT is very promising in
      the pediatric population. Objectives: To correlate the data obtained by the EIT during the
      spontaneous breathing trials (SBT) on a T-piece with failure in the trial and Extubation
      failure and to observe if the EIT is able to detect the children that will fail earlier than
      the SBT performed alone. Method: A cross-sectional, prospective study to explore the
      potential benefits of monitoring with EIT during weaning. Qualitative characteristics will be
      described using absolute and relative frequencies and the quantitative characteristics will
      be described using summary measures (mean, standard deviation, median, minimum and maximum).
      Bivariate and later multiple logistic regression analyzes will be performed to evaluate the
      influence of characteristics assessed on weaning failure, mainly the reduction in functional
      residual capacity during and after the weaning trial. For the analysis will be used the
      software IBM-SPSS for Windows version 20.0 and tabulation of the data will be used Microsoft
      Excel 2010 software. The tests will be performed with significance level of 5%.
    

Intervention name(s): Electrical Impedance tomography
Intervention type(s): Device
Intervention description(s): Monitoring with Electrical impedance tomography during spontaneous breathing trials on T-piece in children
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children who are on mechanical ventilation for a period of more than 24 hours, between 28
        days of age and 15 years, who are admitted to the pediatric intensive care unit (ICU) of
        the Children's Institute in Brazil and are ready for a weaning trial.
      
Keywords: Ventilator Weaning; Child; Electrical Impedance Tomography; Respiration, artificial; Intensive Care units
Active Over 45: A Step-up Jogging Program in Inactive Female Hospital Staff Aged 45+
Condition: Physical Activity
Study type: Interventional

Summary: 
      Background: Inactive individuals face motivational obstacles for becoming and staying
      physically active. Therefore, sustainable physical activity promotion programs tailored to
      reach inactive individuals are needed.

      Purpose: to test the effect (long and short-term) and feasibility of a training program and
      to evaluate the association between the baseline motivation to become physical activity and
      the change in physical activity and performance.

      Design: uncontrolled trail Setting/participants: inactive, female hospital staff aged 45 and
      older from the University Hospital Zurich Intervention: 3-month step-up jogging program Main
      outcome measures: physical performance and level of physical activity
    


Intervention name(s): step-up jogging program
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Spinal Anaesthesia With Chloroprocaine HCl 1% for Elective Lower Limb Procedures of Short Duration.
Condition: Short Duration Lower Limb Surgery Via Spinal Anaesthesia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluate the effect of 3 doses of Chloroprocaine HCl 1% (30, 40 and 50 mg) for
      spinal anaesthesia in adult patients undergoing short duration elective surgery of the lower
      limb. Patients undergoing elective short-duration lower limb surgery will be randomised into
      3 treatment groups (15 patients per group) to receive one of the 3 single doses of
      Chloroprocaine HCl 1%, i.e. either D1, D2 or D3, via intrathecal injection.
    

Detailed description: 
      To evaluate the efficacy of the three Chloroprocaine HCl 1% doses (i.e. D1, D2 and D3) in
      terms of time to complete regression of spinal block (i.e. end of anaesthesia)
    

Intervention name(s): Chloroprocaine HCl 1%
Intervention type(s): Drug
Intervention description(s): Intrathecal Route
Other intervention name(s): Ampres 1%
Intervention MeSH terms: Chloroprocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
The Safety and Effects of 1592U89 Used Alone or in Combination With Other Anti-HIV Drugs in HIV-Infected Infants and Children
Condition: HIV Infections
MeSH terms: Infections; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the steady state pharmacokinetic features, tolerance, and safety of orally
      administered 1592U89, given alone or in combination with other antiretroviral medications, in
      HIV infected infants and children. To establish doses of 1592U89 appropriate for future
      pediatric Phase II/III clinical trials.

      On the basis of the preclinical and clinical studies, 1592U89 appears to be a promising agent
      for treatment of HIV infection in children, either as an alternative to currently employed
      agents, or in combination therapy regimens. A liquid formulation of the drug is available;
      thus concurrent development of 1592U89 for children and adults is possible.
    

Detailed description: 
      On the basis of the preclinical and clinical studies, 1592U89 appears to be a promising agent
      for treatment of HIV infection in children, either as an alternative to currently employed
      agents, or in combination therapy regimens. A liquid formulation of the drug is available;
      thus concurrent development of 1592U89 for children and adults is possible.

      In part 1, patients will receive 1592U89 monotherapy for 12 weeks. Patients will be assigned
      initially to a low dose of 1592U89 (Dose A). Those patients who tolerate the drug for at
      least six weeks without a toxicity of grade 3 or above attributable to study drug will have
      their 1592U89 dose increased (Dose B). If none of those patients experience a life
      threatening event attributable to study drug, subsequent enrollees will be assigned initially
      to Dose B. In part 2, each participant will be assigned randomly (1:1:1:1) within their age
      and Part 1 regimen stratum to one of the four agents: Zidovudine (ZDV), Stavudine (d4T),
      Didanosine (ddI) or Lamivudine (3TC) in combination with 1592U89.
    

Intervention name(s): Abacavir sulfate; Lamivudine; Stavudine; Zidovudine; Didanosine
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Lamivudine; Zidovudine; Abacavir; Stavudine; Didanosine
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug Therapy, Combination; Reverse Transcriptase Inhibitors; Anti-HIV Agents
Gene-Environment Interactions in Complex Disease
Condition: Cardiovascular Diseases; Heart Diseases; Atherosclerosis; Coronary Disease
MeSH terms: Cardiovascular Diseases; Heart Diseases; Atherosclerosis; Coronary Disease
Study type: Observational

Summary: 
      To assess genetic variation in 87 different cardiovascular disease candidate genes and to
      measure the associations of these variants with cardiovascular disease and its risk factors.
    

Detailed description: 
      BACKGROUND:

      Cardiovascular disease (CVD), the number one cause of death in industrialized countries today
      is a complex disease with a multifactorial etiology involving many genetic and environmental
      factors. Public health prevention programs designed to reduce the risk and occurrence of CVD
      commonly focus on modifiable environments and behaviors such as diet and physical activity,
      with varied results among individuals. This heterogeneity in response to CVD interventions is
      at least in part of genetic origin. Although a number of candidate genes have been identified
      which appear to influence the development of CVD, little is known about how these genetic
      effects may vary within demographic (e.g., race and gender) and environmental (e.g., diet and
      exercise) contexts; thus, it is of utmost importance to determine how genes and environments
      interact to produce CVD.

      DESIGN NARRATIVE:

      The purpose of this study is to characterize the environment-dependent effects of 87 biologic
      and positional candidate genes in a population-based sample of 11,625 African-American and
      Caucasian men and women from the Atherosclerosis Risk in Communities (ARIC) study. Candidate
      loci were selected based on confirmed functional significance, consistent association with
      CVD or its risk factors, and or identified as positional candidates in genome-wide linkage
      scans. Environmental contexts will focus on dietary measures (e.g., total kcals, Keys score,
      alcohol intake), obesity, measures of physical activity (sport, leisure, and work indices),
      smoking, and menopause status/hormone use (women only). Outcome variables will include
      measures of quantitative risk factors (e.g., total cholesterol, BMI, blood pressure),
      subclinical disease (carotid wall thickness), and clinical disease (incident coronary heart
      disease (CHD) and stroke). Existing DNA samples will be used for genotyping of candidate
      loci, and no further contact with study participants will be necessary. The ARIC cohort,
      because of its large size and wealth of environmental and physiological measures, provides an
      ideal, timely, and efficient opportunity to evaluate the effects of modifiable environments
      on genetic variation which may influence CVD risk and disease outcomes with the ultimate goal
      of establishing more efficacious programs for the treatment and prevention of CVD.
    

Observational model: Cohort
Time perspective: Prospective
Study population: 
        Subjects aged 14-65 from four communities.
Efficacy of Telerehabilitation in Patients With Degenerative Meniscal Injury
Condition: Meniscus; Degeneration
Study type: Interventional

Summary: 
      The aim of the study is to compare the home exercise program performed with video-based
      telerehabilitation in patients with degenerative meniscal injury, and the home exercise
      program performed with one-on-one training in the hospital with conventional methods.
    

Detailed description: 
      Conventional rehabilitation (CR) practices will be applied to the first study group.
      Telerehabilitation (TR) application will be applied to the second study group. It is aimed to
      evaluate the patients in terms of pain, functionality, quality of life and exercise
      compliance.
    

Intervention name(s): Telerehabilitation; Paper Based Rehabilitation
Intervention type(s): Other; Other
Intervention description(s): Application based video home exercise for the degenerative meniscus injury; Paper instruction based home exercise for the degenerative meniscus injury
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised controlled trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Degenerative meniscus injury; Telerehabilitation
Use of Short Text Messages to Promote Medication Adherence in Hypertensive Patients
Condition: Hypertension; Adherence, Treatment
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      OBJECTIVE: To evaluate the effect of intervention by sending short text messages with a
      reminder of the time of medication use, compared to sending educational messages, on
      adherence to drug treatment in patients with hypertension. METHODOLOGY: Prospective,
      randomized, controlled, double-blind, parallel group study that will be performed in patients
      with hypertension seen at a community pharmacy in Brazil. The following groups will be
      compared: a) intervention group 1: 70 hypertensive patients registered for access to
      medication associated with usual care, in addition to text messages via mobile phone with
      educational information b) intervention group 2: 70 hypertensive patients registered for
      access to medications that will additionally receive text messages at the times indicated in
      the prescription for use of each indicated medication, in addition to educational
      information. After the washout period, the groups will have the active interventions changed
      for an additional 90 days. The proportion of adherent and non-adherent patients with and
      without controlled BP in both groups will be compared after the periods of application of the
      different interventions.
    


Intervention name(s): Educational short message texts; Adherence short message texts
Intervention type(s): Other; Other
Intervention description(s): Educational messages for patient engagement; Reminder messages of medication use time
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Health Services Research
Keywords: Hypertension; Primary Health Care
Teneligliptin and Atorvastatin DDI Study
Condition: Diabete Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, open-label, cross-over, multiple dosing study to evaluate drug-drug interaction
      between Teneligliptin and Atorvastatin in healthy male adults
    


Intervention name(s): Teneligliptin 20mg/day; Atorvastatin 40mg/Day; Teneligliptin 20mg/day + Atorvastatin 40mg/day
Intervention type(s): Drug; Drug; Drug
Intervention description(s): cross-over; cross-over; cross-over
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Effect of a Supervised Exercise Program in Patients With Chronic Low Back Pain
Condition: Low Back Pain; Muscle Atrophy; Diagnostic Imaging; Exercise Therapy
MeSH terms: Muscular Atrophy; Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This study evaluates the effect of a supervised exercise program on paraspinal muscle
      morphology and function, as well as disability/function in patients with non-specific chronic
      low back pain. Half of the participants will do a targeted paraspinal muscle exercise
      program, while the other half will do a general exercise program.
    


Intervention name(s): Targeted exercise program; General exercise program
Intervention type(s): Other; Other
Intervention description(s): Participants in this experimental intervention group will perform a combination of motor control and isolated lumbar extensor strenghtening exercises. The level of difficulty of the exercises will be progressed gradually. The intervention will last 12 weeks, and each participant will have 2 supervised exercise sessions per week.; Participants in this active intervention group will perform a generalized exercise program comprising upper-body and lower-body and hip strengthening exercises, as well as flexibility. The level of difficulty of the exercises will be progressed gradually. The intervention will last 12 weeks, and each participant will have 2 supervised exercise sessions per week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: low back pain; paraspinal muscle; exercise; diagnostic imaging; randomized controlled trial
Bioequivalence Study of Torrent Pharmaceutical Limited's Donepezil Hydrochloride Tablets Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Objective:

      To compare the rate and extent of release of the drug substance from the two tablet
      formulation of Donepezil Hydrochloride Tablets 10mg of Torrent Pharmaceuticals Limited and
      the Aricept® Tablets 10mg of Eisai Inc., Dosing periods were separated by a washout period of
      at least 7 days.

      Study Design:

      Randomized, open label, two treatment, two period, two sequence, single dose, crossover study
      in healthy human adult subjects
    


Intervention name(s): Torrent's Donepezil Hydrochloride Tablets 10mg
Intervention type(s): Drug
Intervention MeSH terms: Donepezil