bioihbjkbjnl/mcl2 huggingface dataset:
The Comparison of HYAJOINT Plus and Hyalgan Hyaluronan Supplement for Knee Osteoarthritis Pain
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The aim of this study was to compare single injection HYAJOINT Plus Synovial Fluid Supplement
      used on the single and repeat treatment of knee osteoarthritis that has the same safety and
      effectiveness as three-injection hyaluronan, Hyalgan.
    

Detailed description: 
      The study was a random, evaluator-blinded, controlled, single center clinical trial.
      Recruiting patients who have been suffered from the osteoarthritis pain under conventional
      nonpharmacologic therapy or analgesics for a long time and randomly divided into two groups,
      HYAJOINT Plus or Hyalgan group, when the inclusion criteria was met and the inform consent
      was obtained. They were followed for 56 weeks including visits at 4, 12, 26, 39, and 52 weeks
      post-treatment for the safety and effectiveness evaluation. After complete 52-week visit,
      subjects would received HYAJOINT Plus on the target knee. These subjects were followed for 4
      weeks to assess the safety of repeat treatment or cross reactions of the use from
      three-injections to single-injection hyaluronan treatment. The primary endpoints were the
      incidence of any adverse events during the study, as well as the objective assessment of pain
      visual analog scale at baseline and every visit.
    

Intervention name(s): HYAJOINT Plus; Hyalgan
Intervention type(s): Device; Device
Intervention description(s): Single-injection, 60 mg / 3 ml (2%) cross-linked hyaluronan; Three-injection, 20 mg / 2 ml (1%) linear hyaluronan
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hyaluronan; synovial fluid supplement
High Dose Chemotherapy Followed By PBSC Rescue for HD
Condition: Hodgkin Disease
MeSH terms: Hodgkin Disease
Study type: Interventional

Summary: 
      To evaluate the role of high dose chemotherapy with autologous hematopoietic cell
      transplantation in the treatment of Hodgkin's Disease.
    

Detailed description: 
      Use of High Dose Chemotherapy Followed by Peripheral Blood Stem Cell Rescue for Relapsed or
      Resistant Hodgkin's Disease
    

Intervention name(s): high dose chemo then auto hematopoietic cell transplant
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Relapse Prevention With Varenicline
Condition: Recurrence; Smoking Cessation; Substance-Related Disorders
MeSH terms: Recurrence; Substance-Related Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to determine if varenicline (Chantix®), currently used as a smoking cessation
      aid, will decrease the likelihood of relapse to smoking following a programmed lapse in the
      laboratory. The hypothesis is that varenicline will reduce the reinforcing effects of smoking
      and will delay or prevent relapse compared to placebo.
    

Detailed description: 
      In this study, the investigators plan to use an experimental model of a lapse, in which
      volunteers smoke two cigarettes after a brief period of (12-24 hours). The goals of this
      study are to assess the impact of varenicline on the subjective and reinforcing effects of
      cigarettes, as well as the latency to resume smoking (relapse) following the lapse exposure.
    

Intervention name(s): Varenicline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Varenicline given twice a day or five weeks.; Placebo given twice a day or five weeks.
Other intervention name(s): Varenicline (Chantix®)
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Diagnostic
Keywords: Relapse; Smoking Cessation; Substance Abuse
Bioequivalency Study of Naratriptan Hydrochloride 2.5 mg Under Fed Conditions
Condition: Migraine
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      The objective of this study was to prove the bioequivalence of Naratriptan Hydrochloride
      Tablet under fed conditions.
    


Intervention name(s): naratriptan hydrochoride
Intervention type(s): Drug
Intervention description(s): 2.5 mg tablet
Other intervention name(s): AMERGE
Intervention MeSH terms: Naratriptan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Resistance Exercise on Metabolic Responses
Condition: Inflammatory Response
Study type: Interventional

Summary: 
      Healthy young adults will complete three trials in a randomized crossover counter-balanced
      order, including two different loads of resistance exercise and sedentary control. During
      each trial, blood samples will be collected.

      The investigators hypothesized that high-load and low-load resistance exercise exert similar
      metabolic responses.
    


Intervention name(s): High-load resistance exercise; Low-load resistance exercise
Intervention type(s): Other; Other
Intervention description(s): Subjects in high-load trial performed 4 sets per exercise, 8 repetitions with load of 85%-8RM with 90 sec of rest between sets.; Subjects in low-load trial performed 4 sets per exercise, 15 repetitions with load of 45%-8RM with 90 sec of rest between sets.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: resistance exercise; equal training volume; immune response
Effects of a Mindfulness Intervention on Temperament, Anxiety and Depression: the Mind the Child Study
Condition: Child, Only; Temperament; Anxiety; Depression
MeSH terms: Depression; Depressive Disorder; Anxiety Disorders
Study type: Interventional

Summary: 
      Background and study aims:

      Mindfulness is a mental state that can be achieved through meditation. So far, studies have
      shown that practicing mindfulness on a consistent and regular basis can improve attentional
      functions and emotional well-being. Mindfulness has recently begun to be used in the field of
      child development. The aim of this study is to assess if a mindfulness program may help
      primary school students in reducing anxiety and depression while also improving their
      temperament.

      Who can participate? Students attending the fourth or fifth year of primary school

      What does the study involve? Participants will be randomly assigned to the experimental and
      control groups. Participants in the experimental group will undergo an 8-week mindfulness
      training program with weekly 60-minute group sessions, while the control group will follow
      routine daily school activities.

      Questionnaires will be used to assess temperament, anxiety and depression before and after
      the intervention.

      What are the possible benefits and risks of participating? Benefits of participating in the
      study may include a lowering of anxiety and depression levels, as well as an improvement of
      temperament.
    


Intervention name(s): Mindfulness-based intervention
Intervention type(s): Behavioral
Intervention description(s): The program consists of a series of awareness practices: the exercises are presented in progression, starting from the awareness of the external environment, then the self-awareness in the environment, the awareness of the body and the five senses, the awareness of the interconnection among the various forms of life and, eventually, meditation exercises that characterize the awareness of the cognitive processes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Child; Mindfulness; Temperament; Anxiety; Depression; Attention
Comparison of Endotracheal Intracuff Pressure Between Two Cuff Sealing Methods
Condition: Endotracheal Tube
Study type: Interventional

Summary: 
      The endotracheal intracuff pressure is to be maintained at a low level to prevent trachea and
      nerve damages, and yet be high enough to secure air sealing. The objective of the study is to
      compare minimal occlusive volume technique (MOVT) and expired volume/inspired volume ratio
      (VE/VI ratio) from a spirometer method of endotracheal tube (ETT) cuff inflation with respect
      to the cuff pressure required to seal the airway during a laparoscopic surgery under general
      anesthesia. A study design is a randomized crossover trial in 35 patients. The primary
      outcome is the intracuff pressure of an endotracheal tube. The study consists of two cuff
      sealing methods separated by a period of 10 minutes.
    


Intervention name(s): MOVT; VE/VI ratio of Spirometer
Intervention type(s): Procedure; Procedure
Intervention description(s): ETT cuff will be inflated till the disappearance of audible air leak on auscultation, while abdominal carbon dioxide (CO2) inflation is maintained with peak inspiratory pressure of 25 cm H2O during volume controlled ventilation. The patient will be in the Trendelenburg position.; ETT cuff will be inflated till the VE/VI ratio meets the initial VE/VI ratio, while abdominal CO2 inflation is maintained with peak inspiratory pressure of 25 cm H2O during volume controlled ventilation. The patient will be in the Trendelenburg position.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Two methods of cuff sealing will be applied in a random sequence to each patient.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Endotracheal tube; Intracuff pressure; Minimal occlusive volume technique; Spirometer; Endotracheal sealing
Continuation Study of the Oral AKT Inhibitor GSK2110183
Condition: Cancer
Study type: Interventional
Phase: Phase 2

Summary: 
      This multicenter, non-randomized, open-label, treatment continuation or 'rollover' study was
      designed to provide continued access to eligible subjects who had previously participated in
      a GSK2110183 study (parent study) sponsored by GlaxoSmithKline (GSK) or another research
      organization working on behalf of GSK. Eligible subjects had previously received clinical
      benefit from continued treatment and had to have ad an acceptable safety profile with
      GSK2110183. Subjects who had participated in a GSK2110183 combination study with an approved
      anti-cancer agent were also be eligible to enroll in this rollover study. Subjects who
      participated in combination studies with two investigational compounds (one being GSK2110183)
      were not eligible for this rollover study. Subjects were enrolled by cohort based on the
      duration and treatment received while in their parent study. Safety assessments (physical
      examinations, vital sign measurements, 12-lead electrocardiograms, echocardiograms or
      multiple-gated acquisition scans, clinical laboratory assessments and monitoring of adverse
      events) were evaluated during this study. Disease assessment were performed using local
      standard of care imaging practices and criteria appropriate for disease type and location.
    


Intervention name(s): GSK2110183 (afuresertib)
Intervention type(s): Drug
Intervention description(s): Afuresertib is an oral, low nanomolar pan-AKT kinase inhibitor immediate release (IR) 50 mg or 75 mg tablets was to be taken orally with at least 200 mL of water, with or without food, in the morning.
Other intervention name(s): ASB183
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: solid tumor; GSK2110183; hematologic malignancy; AKT inhibitor; cancer; safety
Anatomical and Functional Results of Surgery of the Tympanic Membrane Perforation of the Child
Condition: Tympanic Membrane Perforation; Tempanoplasty
MeSH terms: Tympanic Membrane Perforation
Study type: Observational

Summary: 
      This study is a retrospective cohort of patients minors during the operation of cartilage
      tympanoplasty for tympanic membrane perforation
    

Detailed description: 
      The investigators hypothesis is that the cartilage tympanoplastie lead to a closure of the
      tympanic membrane in 95% of cases. But the investigators believe that certain risk factors
      may influence the anatomical and functional results of tympanoplastie of the child and that
      their inclusion could improve these results.

      For example, young age is not clear so far as a potential risk factor in the few studies
      analyzing this factor independently. A recommendation of the French Society of ENT surgery
      tympanic membrane perforation of the Child in 2006 recommended a minimum age of 6 years.
      However, the level of evidence of articles analyzed was small (it was basically a consensus
      of experts) and the investigators feel it necessary to study this factor by age (<7 years,
      7-10 years, 11-14 years ,> 14 years) on a large cohort to determine the real influence of age
      on the anatomical and functional results as this may lead to changes in practice.

      Similarly, whatever the influence of age in the general population, it could be a key
      criterion in children who have a particular field leading to prolonged tubal dysfunction
      (vélopalatines slots and craniofacial malformations), leading to raising the age of surgery
      tympanic closure: the investigators have for example in 1000 tympanoplasties for perforation,
      expected recruitment numbers in this study, 50 patients with craniofacial malformation or
      vélopalatine slot.

      The purpose of this study is to investigate the factors influencing the anatomic outcome at
      one year of cartilage tympanoplastie child.
    

Intervention name(s): Collection of anatomical and functional results in the appearance of the tympanic membrane after surgery
Intervention type(s): Other
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric ENT Head and Neck Surgery, Necker hospital.
      
Keywords: Childrens; tempanoplasty; tympanic membrane perforation; retrospective; cohort
Effects of Multipoint Pacing CRT-D on Neurohormonal Activation.
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      This study will examine the additional clinical benefit conferred by multipoint pacing (MPP)
      compared to standard CRT over a period of 3 months. Patients will be randomized to MPP ON vs.
      OFF and followed for a total of 6 months. This includes two crossover periods for each pacing
      modality (MPP on vs. off).
    

Detailed description: 
      Cardiac resynchronization therapy (CRT) is limited by a high proportion of non-responders.
      Pacing activation from multiple separated left ventricular (LV) sites might improve the
      depolarization pattern, thereby promoting more physiological activation. To explore the
      effect of MPP on cardiac neuro-hormonal activity, the investigators will enroll approximately
      30 patients who already underwent CRT-D implantation with a quadripolar LV lead connected to
      a device capable of MPP.

      This pilot study will have a randomized, double-blind, cross-over design. Patients will be
      randomized to receive either standard biventricular pacing (MPP-OFF) or MPP (MPP-ON) within
      4-6 months following the implantation procedure. Each subject will crossover to the other
      study group after three months. The baseline evaluation should be acquired prior to the
      device being programmed to the randomized setting. Repeat evaluations will be performed at
      the end of each 3 month crossover period.

      Participation in this study will last approximately 6 months. Patients, as well as
      investigators other than the EP physicians, will be blinded to the pacing mode.
    

Intervention name(s): Cardiac Resynchronization Therapy with MultiPoint Pacing
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cardiac Resynchronization Therapy; non responders; MultiPoint Pacing (MPP)
Health Evaluation of Mushrooms withVitamin D2
Condition: Healthy
Study type: Interventional

Summary: 
      Although Taiwan has plenty of sunshine, the intake of vitamin D and the concentration of
      25(OH)D in the blood are low. Ingestion of mushrooms and extracts rich in D2 can increase the
      nutritional source of vitamin D. The purpose of this study is to evaluate the intake of D2
      mushrooms and extracts in humans to achieve the effective concentration of 25(OH)D in the
      serum and recommendations for health improvement.
    

Detailed description: 
      The subjects were divided into 3 groups: no mushroom intervention, intervention with D2 10ug
      Pleurotus citrinopileatus after bio-optics optimization (low dose group) or intervention with
      D2 100ug Pleurotus citrinopileatus after bio-optics optimization (high dose group). The
      low-dose group took D2 10ug per day, and the high-dose group received D2 100ug per day for a
      total of 4 weeks.
    

Intervention name(s): Pleurotus citrinopileatus after bio-optics (10 ug group); Pleurotus citrinopileatus after bio-optics (100 ug group)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The participants took D2 10ug per day for a total of 4 weeks.; The participants took D2 100ug per day for a total of 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Clinical Pharmacology Study to Evaluate the Effect of GYM329 on Disuse Muscle Atrophy in Healthy Volunteer
Condition: Healthy Volunteers
MeSH terms: Muscular Atrophy; Atrophy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will induce disuse atrophy through unilateral immobilization of the thigh and
      lower leg in healthy male volunteers to evaluate the PD of a single subcutaneous dose of
      GYM329 prior to or after unilateral thigh and lower leg immobilization.

      Healthy male volunteers will receive either GYM329 or placebo by subcutaneous injection at
      two time points, before and after 2 weeks of unilateral thigh and lower leg immobilization,
      in an investigator- and subject-blinded, randomized, placebo-controlled, parallel-group
      design. At enrollment, all subjects will be randomized in a 1:2 ratio to either the
      pre-immobilization active drug group receiving a single subcutaneous dose of GYM329 before
      unilateral thigh and lower leg immobilization (Group A) or the pre-immobilization placebo
      group receiving a single subcutaneous dose of placebo before unilateral thigh and lower leg
      immobilization (Group B). On Day 15, subjects assigned to Group B and who completed the
      muscle strength assessment at Day15 will be further randomized in a 1:1 ratio to either the
      post-immobilization active drug group (Group B-1) or the post-immobilization placebo group
      (Group B-2). Group A will receive GYM329 on Day 1 and placebo on Day 15. Group B will receive
      placebo on Day 1. Subsequently, Group B-1 will receive GYM329 on Day 15 and Group B-2 will
      receive placebo on Day 15.

      Muscle strength will be measured at pre-immobilization of unilateral thigh and lower leg,
      post-immobilization of unilateral thigh and lower leg (Day 15), Day 29, and Day 43. Subjects
      will be observed for 252 days after the second study treatment administration (266 days after
      the first study treatment administration).
    


Intervention name(s): GYM329; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GYM329 subcutaneous injection; Placebo subcutaneous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety of Actiponin on Antiobesity in Obese Korean Subjects.
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      Obesity is a major health issue worldwide; there is a constant raise in obesity related death
      each year. In vitro and animal studies elucidated Actiponin as a novel anti-obesity agent.
      However, the efficacy and safety of Actiponin supplementation on body weight regulation in
      humans are lacking.
    

Detailed description: 
      The primary aim of the study was to investigate the effect of Actiponin in Korean subjects on
      body weight and fat loss along with changes in metabolic markers based on 12 week,
      randomized, double-blind, placebo-controlled clinical trial.

      Eighty obesity subjects with BMI > 25kg/m2 and waist-hip ratio (WHR) ≥ 0.90 for men and ≥
      0.85 for women were randomly divided into either Actiponin (n=40, 450mg/day) or placebo group
      (n=40, 450mg/day) for 12weeks.
    

Intervention name(s): Actiponin; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material.; Amount and calorie of placebo are same with Actiponin.
Other intervention name(s): Extract of Gynostemma pentaphyllum(450mg/day); Placebo(450mg/day)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Actiponin; Obesity; Abdominal fat
Drug Interaction Between Irbesartan and Hydrochlorothiazide
Condition: Healthy
Study type: Interventional

Summary: 
      This study was conducted to investigate any potential reaction between irbesartan and
      hydrochlorothiazide.
    


Intervention name(s): Irbeasartan/hydrochlorothiazide; Irbesartan; Hydrochlorothiazide
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Fixed dose combination
Intervention MeSH terms: Hydrochlorothiazide; Irbesartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Fixed dose combination; Pharmacokinetics; Irbesartan; Hydrochlorothiazide; Pharmacodynamics; Normotensive Participants
Effects of a Mechanical Needle Stimulation Pad on Chronic Low Back Pain
Condition: Chronic Low Back Pain; Recurrent Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The needle stimulation pad is a self-care device, which has been promoted for pain control
      and well-being. The aim of the study was to test the efficacy of the pad for
      chronic/recurrent low back pain treatment.

      Patients with non-specific chronic or recurrent low back pain were selected from a large
      health insurance company database and advised to use the pad daily for two weeks; outcomes
      were assessed at baseline, weeks 2 and 14. Primary outcome measure was pain intensity at week
      2; secondary outcome measures included the Oswestry disability index (ODI), health-related
      quality of life (SF-36), the fear avoidance beliefs questionnaire (FABQ), analgesic
      medication consumption and safety.
    

Detailed description: 
      see above
    

Intervention name(s): Needle stimulation pad
Intervention type(s): Device
Other intervention name(s): Shakti mat, Bed of nails
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment