bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Two Treatments in Intermediate and High-risk Acute Promyelocytic Leukemia (APL) Patients to Assess Efficacy in 1st Hematological Complete Remission and Molecular Remission
Condition: Leukemia, Myelocytic, Acute
MeSH terms: Leukemia; Leukemia, Promyelocytic, Acute; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will compare the efficacy of the 2 treatments in intermediate and high-risk APL
      patients in achieving first hematological complete remission and molecular remission.
    


Intervention name(s): gemtuzumab ozogamicin; ATRA plus 6-MP and MTX
Intervention type(s): Drug; Drug
Intervention description(s): 2 IV infusions 6 mg/m2 administered monthly; 6-MP 50 mg/m2/day PO; MTX 15 mg/m2/q week IM; ATRA 45 mg/m2/day PO
Other intervention name(s): Arm A; Arm B
Intervention MeSH terms: Gemtuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Oncology comparison study
A Trial of Antroquinonol in Patients With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-centers, phase IIa, double blind, randomized, placebo-controlled trial of
      Antroquinonol in patients with atopic dermatitis.Duration of treatment is 12 week in total.
      Study visits will occur every 4 weeks. AEs/SAEs, changes to concomitant medications will be
      noted, vital signs will be taken, and efficacy evaluations will be performed as well. The
      last estimation of variable scores will occur for all subjects.
    

Detailed description: 
      This is a multi-centers, phase IIa, double blind, randomized, placebo-controlled trial of
      Antroquinonol in patients with atopic dermatitis.Duration of treatment is 12 week in total.
      Study visits will occur every 4 weeks. During these visits study drug will be administered at
      the site, new AEs/SAEs as well as follow-up for AEs and SAEs that have not been resolved will
      be recorded, changes to concomitant medications will be noted, vital signs will be taken, and
      efficacy evaluations will be performed as well. The study includes collection of cytokines
      samples. The end-of-treatment visit and the last estimation of variable scores will occur at
      week 13 (visit 5) for all subjects. The final visit will be at week 15 (visit 6). Subjects
      will be encouraged to complete all planned visits regardless of their adherence to study drug
      administration.
    

Intervention name(s): Antroquinonol; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Antroquinonol will be provided as a capsule-shaped which contain 50 mg Antroquinonol.; The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects
Other intervention name(s): Hocena
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a multi-centers, phase IIa, double blind, randomized, placebo-controlled trial of Antroquinonol in patients with atopic dermatitis. Subjects with diagnosis of atopic dermatitis, using the Hanifin and Rajka Diagnostic Criteria, who meet inclusion/exclusion criteria will be randomized into 3 groups:
Antroquinonol 100 mg PO QD
Antroquinonol 50 mg PO QD
Placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Antroquinonol; Hocena
The TENDERA Multicenter Clinical Trial
Condition: Artery; Thrombosis
MeSH terms: Thrombosis
Study type: Interventional

Summary: 
      TENDERA is a multicenter randomized controlled trial to compare traditional entry point in
      the radial artery for TRI and distal puncture at the anatomical snuffbox area for transradial
      Interventions. The Investigators hypothesized that novel entry point in radial artery may
      lessen vascular access site complication rate and especially the radial artery late occlusion
      rate.
    

Detailed description: 
      the forearm access will be made using traditional technique what was well described
      previously in the literature. The novel puncture site is located in the snuffbox area distal
      to the traditional radial access point. Thanks to surrounded anatomical conditions in
      anatomical snuffbox area vascular access site complications may be lessened comparing to
      forearm radial access site.
    

Intervention name(s): transradial interventions
Intervention type(s): Device
Intervention description(s): percutaneous coronary interventions in stable patients - diagnostic and treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Transradial intervention,radial artery,anatomic snuffbox
Mother-infant Signalling During Breastfeeding
Condition: Breastfeeding Women
Study type: Interventional

Summary: 
      Primary hypotheses

      1. The use of a relaxation tape by breastfeeding mothers that will be given starting at week
      2 postpartum, will result in : i) reduced maternal stress and anxiety ii) the production of a
      higher volume of breast milk iii) lower milk cortisol concentrations iv) favourable effects
      on infant behaviour (less crying, more sleeping) v) higher milk intake by the infant vi) more
      optimal growth, specifically higher lean mass and lower fat mass (body composition)

      Secondary hypotheses (i) Infant temperament/behaviour and gender influence milk and energy
      intake and hence early growth and body composition (ii) Non-nutrient factors in breast milk
      (hormones including ghrelin and leptin) influence infant behaviour and feeding patterns and
      hence infant growth and body composition.
    


Intervention name(s): Relaxation
Intervention type(s): Behavioral
Other intervention name(s): Relaxation tape - audio tape with visual imagery and relaxation exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Breastfeeding, relaxation, anxiety, infant growth
Effect of Vibratory Expiratory Pressure on Pulmonary Function After Lung Resection Surgery
Condition: Pulmonary Resection Surgery
Study type: Interventional

Summary: 
      Postoperative airway clearance and recovery of pulmonary function after lung resection is
      critical in patients undergoing pulmonary resection surgery. The investigators hypothesized
      that vibratory positive expiratory pressure using the Acapella device may improve pulmonary
      function recovery in patients undergoing video-assisted thoracoscopic lung resection surgery.
    


Intervention name(s): Acapella device
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Adults (15-40 Yrs).
Condition: Hepatitis B
MeSH terms: Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluates the safety and immunogenicity of the candidate HBV-MPL vaccine
      administered to healthy adults aged from 15 to 40 years, according to a 0, 6- month
      vaccination schedule, with Engerix™-B as control administered at 0, 1, 6 months.
    

Detailed description: 
      At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former
      name SmithKline Beecham
    

Intervention name(s): HBV-MPL vaccine 208129; Engerix™-B
Intervention type(s): Biological; Biological
Intervention description(s): 2-dose intramuscular injection; 3-dose intramuscular injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hepatitis B; Recombinant hepatitis B vaccine; Adjuvanted hepatitis B vaccine
Assess Whether Knowledge by the Younger of the Function of the Accelerometer Determines Its Amount of Physical Activity
Condition: Physical Activity
Study type: Interventional

Summary: 
      Eighty healthy youngsters, aged 10-18 years, will be equally randomized between the blinded
      and the non-blinded group. The blinded subjects will be informed that we were testing the
      reliability of a new device for body posture assessment and these youngsters will did not
      receive any information with regards to physical activity. Conversely, the non-blinded
      subjects were informed that the device was an accelerometer that assessed physical activity
      levels and patterns. Participants will be instructed to wear the accelerometer for 4
      consecutive days and to keep a non-wear log diary over the 4 day-monitoring. The overall
      duration and the duration relative to the quality of the physical activity patterns
      (sedentary, light, moderate, vigorous and moderate to vigorous) were computed for each group
      during the 4-day monitoring, then compared between the two groups using the Student's t test.
    


Intervention name(s): GT3X Actigraph accelerometer.
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Prevalence Rate, and Clinical Characteristics of Obesity Hypoventilation Syndrome Via Screening Patients Admitted to Medical Intensive Care Units
Condition: Obesity Hypoventilation Syndrome
MeSH terms: Hypoventilation; Obesity Hypoventilation Syndrome; Obesity; Syndrome
Study type: Observational

Summary: 
      A prospective observation study to screen adult obese (BMI ≥30 kg/m2) patients who were newly
      admitted to the medical intensive care units and turned out to be diagnosed as Obesity
      hypoventilation syndrome(OHS). The investigators purpose is to look into the prevalence,
      predictive factors, and outcomes of OHS in these critically ill patients.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        adult obese (BMI ≥30 kg/m2) patients who were newly admitted to the medical intensive care
        units and turned out to be diagnosed as obesity hypoventilation syndrome
LANN-study: Lantus, Amaryl, Novorapid, Novomix Study
Condition: Diabetes Mellitus Type II
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Many diabetics gain weight while on insulin therapy. In this study, we evaluate the efficacy
      of the combination of glimepiride and short-acting insulin on weight control and glucose
      control. In this study, 150 diabetics whose diabetic control is inadequate while on maximal
      oral treatment will be randomized to either the new combination treatment or twice daily
      injections with a mixture of short- and longacting insulin or once-daily injection with a
      basal insulin analog. The study will compare glucose control and weight gain during a year
      after randomisation between the three treatments.
    

Detailed description: 
      Diabetic patients failing on maximal oral treatment usually switch to twice daily
      administration of a mixture of short- and longacting insulin. Although this improves glycemic
      control, it is generally accompanied by a substantial gain in body weight. This may lead to
      an increase in body fat resulting in a worsening of insulin resistance, leading to an
      increase in insulin dose needed to maintain glycemic control.

      The combination of glimepiride(amaryl) and short-acting insulin (novorapid) is thought to
      attain glycemic control with a smaller increase in body weight.

      In this randomized controlled trial, 150 diabetics failing on maximal oral treatment will be
      randomized to preprandial use of Novorapid combined with Amaryl at 20.00 hours, twice daily
      Novomix 30, or once daily Lantus. Metformin will be continued.

      In the year after randomisation, patients will be followed for glycemic control, body weight,
      body composition, recorded number of hypoglycemic events, plasma lipid levels, basal and
      stimulated C-peptide levels and adverse effects.
    

Intervention name(s): Novomix 30; Novorapid and Amaryl; Lantus
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Insulin Aspart; Insulin aspart, insulin aspart protamine drug combination 30:70
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes; failing oral treatment; weight gain
AST Combined With 0.05% Cyclosporin Eye Drop Improve Corneal Nerve Density in Patients With SS Dry Eye
Condition: Sjogren's Syndrome; Dry Eye; Ocular Surface Disease
MeSH terms: Sjogren's Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome
Study type: Observational

Summary: 
      The objective of the present study was to evaluate the efficacy of autologous serum tears
      combined with 0.05% cyclosporin eye drop in treating Sjögren's syndrome dry eye and their
      effect on corneal nerves. We assessed the impact of 12-week AST combined with 0.05%
      cyclosporin eye drop treatment on signs, symptoms, and sub-basal nerve density (SND) in
      patients with dry eyes related to Sjogren's syndrome.
    

Detailed description: 
      Objective: To describe the clinical efficacy and safety of the treatment of Sjögren's
      syndrome dry eye using autologous serum tears combined with 0.05% cyclosporin eye drop and to
      evaluate their effect on corneal nerves.

      Design: Singal-center, prospective, observational study. Patients and methods: Thirty eyes of
      fifteen patients with dry eye related to Sjögren syndrome were enrolled in this study.
      Following a 4-week washout period, the treatment was inverted for each patient for the same
      duration and treatment. Ocular Surface Disease Index (OSDI), tear film, break-up time,
      corneal staining with the use of fluorescein, Schirmer's test and corneal confocal microscopy
      were investigated.
    

Intervention name(s): Autologous serum tears combined with 0.05% cyclosporin eye drop
Intervention type(s): Drug
Intervention description(s): All patients administrated autologous serum tears twelve times daily（per hour） and 0.05% cyclosporin eye drop twice times daily in each eye for 12 weeks.
Other intervention name(s): Ciclosporin Eye Drops(II)（Cyclone® ，SHENYANG XINGQI PHARMACEUTICAL Co., Ltd.）
Intervention MeSH terms: Cyclosporine; Ophthalmic Solutions; Cyclosporins
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        From June 2022 to June 2023, moderate and severe dry eye patients with Sjogren's syndrome
        were treated in the Department of Ophthalmology and Rheumatology and Immunology of the
        Hospital of Chengdu University of Traditional Chinese Medicine.
      
Keywords: autologous serum tears; 0.05% cyclosporin eye drop; cornea nerves
Platelet-rich Plasma for Low Back Pain
Condition: Discogenic Pain; Platelet-rich Plasma
MeSH terms: Low Back Pain
Study type: Interventional

Summary: 
      This study aims to evaluate the effect of platelet-rich plasma (PRP) on discogenic low back
      pain by comparing the pre- and post-interventional outcomes in patients receiving intradiscal
      injection of autologous PRP.
    

Detailed description: 
      Intervertebral disc (IVD) degeneration is an important clinical problem that often
      contributes to low back pain and degenerative disc diseases. Degeneration of the IVD induces
      anulus tears and fissures, which can cause severe discogenic low back pain. Because the IVD
      has little potential to self-regenerate, treatment of degenerative disc disease is one of the
      most challenging clinical problems facing the spine surgeon. Platelet-rich plasma (PRP) is a
      fraction of plasma that contains platelets and multiple growth factors concentrated at high
      level. Because activated platelets have the potential to release growth factors, PRP has been
      clinically used to accelerate wound healing and tissue regeneration in orthopedic and oral
      surgery. The soluble releasate isolated from PRP has recently been demonstrated to influence
      the metabolism of intervertebral discs in vitro. Furthermore, an intradiscal injection of
      autologous PRP has been shown to induce restoration of structural changes in the rabbit
      annular injection model in vivo. This clinical trial aims to investigate the safety and
      efficacy of intradiscal PRP injection in patients with discogenic low back pain. The pre- and
      post-interventional imaging and clinical outcomes will be compared.
    

Intervention name(s): Platelet-rich plasma
Intervention type(s): Other
Intervention description(s): intradiscal injection of plasma-rich platelet
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Platelet-rich plasma; Intervertebral Disc Degeneration; Low Back Pain
Biological Markers of Response to Treatment in Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to find out if two tests are useful in predicting whether
      someone with depression will get better when he or she is treated with an FDA approved
      antidepressant medication (either citalopram or escitalopram).
    

Detailed description: 
      Major depressive disorder (MDD) is a severe form of depression. MDD can significantly
      interfere with an individual's thoughts, behavior, mood, and physical health. People who
      suffer from MDD often experience feelings of worthlessness; they may feel hopeless and may be
      unable to cope with problems in their life. In addition, they often experience sleep
      disruption, loss of appetite, and chronic pain.

      It often takes several weeks to find out if an antidepressant medication is going to work for
      someone. This research study aims to identify tests that are able to predict if a medication
      will work, even before a person starts to feel better. The first test is a measurement of the
      blood protein Brain-Derived Neurotrophic Factor (BDNF), which is involved with brain cell
      growth. The second test is a Quantitative Electroencephalogram (QEEG), which measures brain
      activity.

      The study lasts for 8 weeks and involves 5 total visits to the clinic. Throughout the study,
      all subjects will receive either escitalopram (Lexapro) or citalopram (Celexa) on the basis
      of the study doctor's clinical judgment. The dose of the medications can be increased at any
      point in time if the study doctor thinks it is appropriate. After the first screen visit
      (which lasts about 3 hours), each subsequent half-hour visit will involve a 2-tablespoon
      blood draw to measure BDNF levels, as well as a QEEG in which small, painless electrodes are
      stuck to the subject's forehead and electrical activity of the brain is measured. At the end
      of the 8 weeks, subjects are offered 3 months of free follow-up care, including medications.
    

Intervention name(s): open-label selective serotonin reuptake inhibitor (SSRI)
Intervention type(s): Drug
Intervention description(s): Duration is 8 weeks. For escitalopram, starting dose is 10mg po qd,which can be increased up to 30mg po qd per clinical discretion. For citalopram, starting dose is 20mg po qd, which can be increased up to 60mg po qd per clinical discretion.
Other intervention name(s): escitalopram or citalopram
Intervention MeSH terms: Citalopram; Escitalopram; Selective Serotonin Reuptake Inhibitors; Serotonin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: depression; biology
Role of Peanuts in Healthy Weight Gain in Athletic Individuals
Condition: Weight Gain
MeSH terms: Body Weight; Weight Gain
Study type: Interventional

Summary: 
      Many athletes and military personnel desire weight gain primarily as lean mass to improve
      performance and effectiveness in military/sport endeavors. While much is known about the
      energy restriction required to reduce body weight, very little is understood about energy and
      macronutrients needed to promote healthy gains in body weight and lean mass. Typically,
      athletes are encouraged to increase calorie intake by ~500 kcal/day with an emphasis on
      adequate protein and carbohydrate, and judicious inclusion of healthy fat-containing
      calorically-dense foods, including peanuts and peanut butter. This study proposes to evaluate
      the effect of a 10-week diet and exercise regimen designed to promote healthy weight gain.
      This will include increasing energy intake by 500 additional kcal/day (above weight
      maintenance diet) through daily provision of either peanut-based whole foods/snacks (peanut
      group) or a similar, high-carbohydrate, peanut-free snack (control group) along with a
      supervised strength training regimen. Results will serve as an important first step in
      helping understand the gaps in knowledge related to healthy weight gain, designing better
      weight gain meal plans, not only in athletes and military personnel, but also in clinical
      populations where promotion of weight gain is advocated.
    


Intervention name(s): Peanut snacks; No peanut-containing snacks
Intervention type(s): Other; Other
Intervention description(s): Participants will undergo a 10-week diet and weight training regimen to promote healthy weight gain. These participants will receive seven 500 kcal peanut-containing (whole peanuts or peanut butter) snacks each week and consume one snack per day throughout the study. They will also perform a series of weight training exercises supervised by a personal trainer on 3 days per week.; Participants will undergo a 10-week diet and weight training regimen to promote healthy weight gain. These participants will receive seven 500 kcal non-peanut-containing high carbohydrate snacks each week and consume one snack per day throughout the study. They will also perform a series of weight training exercises supervised by a personal trainer on 3 days per week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypercaloric diet; Weight training; Lean mass; Body composition