bioihbjkbjnl/mcl2 huggingface dataset:
Chronic Intermittent Cold Exposure on Weight Loss
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      1. To test whether chronic intermittent cold exposure is more effective in programmed body
           weight loss when compared to conventional programmed weight loss.

        2. To measure the metabolic responses (e.g. in the white and brown adipose tissue, muscle
           and circulating markers) of treatment with chronic intermittent cold exposure and
           conventional treatment

        3. To measure tissue specific changes of weight loss and the treatment with chronic
           intermittent cold exposure in glucose uptake rate in adipose organ (white and brown
           adipose tissue), liver, myocardium, skeletal muscle and brain

        4. To measure tissue specific biochemical indicators before and after treatment with
           chronic intermittent cold exposure from white adipose tissue and skeletal muscle.

        5. To compare changes in body composition and fat distribution after weight loss using
           chronic cold exposure or using conventional method
    


Intervention name(s): Whole body cryotherapy; counseling and behavioral therapy for weight loss
Intervention type(s): Biological; Behavioral
Intervention description(s): Cryotherapy: The whole-cody cryotherapy device (Univers Cryo-Combi;Oy MJG Univers Ab, Helsinki, Finland) consists of 3 chambers set at different temperatures. The first 2 chambers are meant for precooling (-30°Cand-60°C), and the patient remains in these for a very short time. The third chamber temperature reaches -110°C, and the patient remains inside for 3-4 minutes wearing a bathing suit or trunks, acral parts covered.; Weight loss intervention with Very Low Calory Diet (VLCD, 500-1000 kcal / d + dietary supplements) and group and individual treatment (eating, physical activity counseling and behavioural therapy).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Weight loss; brown adipose tissue; white adipose tissue; muscle, metabolism; cold exposure
Single Dose Partial Breast Radiotherapy
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This study seeks to determine the maximum tolerated dose of a single-dose partial breast
      radiation given before lumpectomy using a radiosurgery technique. Lumpectomy will be
      performed within 3 weeks (+/- 1 week) of completing radiation.
    

Detailed description: 
      This study will assess the safety of partial breast radiosurgery as measured by the incidence
      of acute toxicity and wound healing complications in three dose cohorts.

      Patients will be enrolled in cohorts of 8 patients starting at dose level 1 (15 Gy). If 2 or
      more dose limiting toxicities (DLTs) are observed at dose level 1, the trial will be stopped
      for evaluation and consideration of revision. If at most one DLT is observed then escalation
      continues to the next dose level. The cohorts will escalate by 3Gy up to 21 Gy of
      irradiation.
    

Intervention name(s): Radiosurgery
Intervention type(s): Radiation
Intervention description(s): Single dose or radiation in 15Gy, 18Gy or 21Gy
Other intervention name(s): External beam radiation therapy
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer of Breast; Cancer of the Breast; Neoplasms, Breast; Single dose radiation; Radiotherapy; Preoperative
A Study of Neurostyle Brain Exercise Therapy Towards Enhanced Recovery (nBETTER) for Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      A feasibility trial of Neurostyle Brain Exercise Therapy Towards Enhanced Recovery (nBETTER)
      system for Brain Computer Interface (BCI) neurofeedback for rehabilitation of the subacute
      and chronic hemiplegic upper limb aimed at improving upper limb recovery for subacute to
      chronic stroke patients.
    

Detailed description: 
      Stroke remains the 4th cause of death in Singapore and despite advances in neuro-medical care
      and rehabilitation, 40-50% of stroke survivors are left with permanent neuro-disability and a
      reduced quality of life. The previous 2 decades has seen exponential leaps in the development
      of rehabilitation technologies which enhance neuroplasticity and rehabilitation outcome. One
      of these potentially useful technologies is nBETTER System, was developed by Institute for
      Infocomm Research, Agency for Science, Technology and Research (A*STAR). nBETTER is a
      portable, internet-connected device that detects the imagination of movement of
      stroke-affected limb using a Electroencephalography (EEG)-based Brain-Computer Interface
      (BCI) thus delivering visually engaging feedback for directed neurofeedback aimed at
      improving upper limb recovery for subacute to chronic stroke patients. The pilot study aims
      to recruit 13 patients using a multi centre trial design to investigate nBETTER system
      feasibility and safety for rehabilitation of subacute to chronic stroke patients with upper
      limb motor impairment and to determine clinical efficacy, safety and feasibility of such a
      system when it is delivered with standard occupational therapy.

      The investigators primary hypothesis is that nBETTER is a feasible and safe prototype in
      stroke survivors (> 3 months) with moderate to severe arm impairment (FMMA 10-50). The
      primary outcome is a gain of 15% in Fugl-Meyer motor scores at 6 weeks after 18 sessions
      (total of 27 hours) of supervised training by occupational therapists and bioengineers.
    

Intervention name(s): nBETTER
Intervention type(s): Device
Intervention description(s): 60 minutes of nBETTER training followed by 30 minutes of conventional therapy occupational therapy. Total of 18 sessions over 6 weeks.
Intervention model: Single Group Assignment
Intervention model description: Feasibility of nBETTER training (60 minutes) with conventional arm therapy (30minutes) for chronic stroke.
Masking: None (Open Label)
Primary purpose: Device Feasibility
F511 Cream in Preventing Palmar-Plantar Erythrodysesthesia in Patients Receiving Doxorubicin Hydrochloride Liposome for Metastatic Breast Cancer
Condition: Breast Cancer; Palmar-plantar Erythrodysesthesia
MeSH terms: Breast Neoplasms; Hand-Foot Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: F511 cream may prevent or reduce palmar-plantar erythrodysesthesia in women
      receiving doxorubicin hydrochloride liposome for metastatic breast cancer.

      PURPOSE: This randomized phase III trial is studying F511 cream to see how well it works
      compared with a placebo cream in preventing palmar-plantar erythrodysesthesia in patients
      receiving doxorubicin hydrochloride liposome for metastatic breast cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Evaluate the effects of F511 cream on the occurrence of palmar-plantar
           erythrodysesthesia (PPE) in patients with metastatic breast cancer treated with
           pegylated liposomal doxorubicin hydrochloride.

      OUTLINE: This is a multicenter study.

      Patients receive pegylated liposomal doxorubicin hydrochloride according to local practice on
      1, 2, or 4 weeks course schedules with at least 10 mg/m^2 per week allowed.

      Patients apply F511 cream on one side, hand and foot and the corresponding placebo on the
      other side hand and foot once daily (the morning) during the first week of the first
      pegylated liposomal doxorubicin hydrochloride treatment only, then once daily, three times
      per week thereafter. Treatment continues throughout chemotherapy administration in the
      absence of palmar-plantar erythrodysesthesia (PPE) ≥ grade 2

      After completion of study therapy, patients are followed for 30 days. Patients with PPE ≥
      grade 2 are followed until the PPE resolves to ≤ grade 1.
    

Intervention name(s): antiperspirant cream F511; pegylated liposomal doxorubicin hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): Placebo and verum cream once daily, in the morning, during the first week of the first PLD treatment only, then once daily, three times per week (in the morning). Tube R for right hand and foot, tube L for left hand and foot.; According to local practice. 1, 2 and 4 week schedules with at least 10mg/m2 per week are allowed.
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: palmar-plantar erythrodysesthesia; stage IV breast cancer; male breast cancer
Efficacy of Piroxicam as a Perioperative Analgesic for Patients Undergoing Fixation of Maxillofacial Fractures
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Early Phase 1

Summary: 
      At Eldemerdash Hospital at Ain Shams University in Egypt, 72 adult patients (16 to 25 years
      old) who had mandibular or maxillary fractures were treated with open reduction and internal
      stabilization. Patients were divided into two categories. (31 patients each) Using randomly
      generated data from computer, the piroxicam group received 0.4 mg/kg of intramuscular
      piroxicam, while the general anesthesia group (GA group) did not receive piroxicam.

      The overall amount of rescue analgesic dosage and postoperative complications like nausea and
      vomiting were therefore included in the outcomes measurement.
    

Detailed description: 
      Patients were divided into two groups at random using a computer-generated list: the GA group
      received no piroxicam and the piroxicam group got a 0.4 mg/kg IM piroxicam induction. Both
      groups got IV paracetamol (24 mg/kg slowly administered over 20 minutes).

      Fentanyl 2 micrograms/kg was administered after general anesthesia was induced and venous
      access was established. A suitable size endotracheal tube was then placed intranasal, and
      intubation was aided by Atracurium (0.5 mg/kg). Throughout the operation, 1 MAC isoflurane in
      a mixture of 50% air and oxygen was used to maintain anesthesia in all patients who were
      mechanically ventilated in pressure-controlled mode with targeted EtCO2 (30-35 mmHg). An oral
      pack was also introduced.

      After the operation general anesthesia was stopped and the endotracheal tube was removed,
      Neostigmine 50 mg/kg and atropine sulfate 15 mg/kg were used to reverse muscle relaxation.
      Patient transportation was made to the post-anesthesia care unit (PACU). Postoperative
      analgesia was evaluated by a blind investigator using 10 cm- visual analogue scale score
      which had been explained to the patient on the preoperative visit where: 0 = no pain, 10 =
      worst possible pain) in the PACU then at 3, 6, 12, 24 hours, if the pain score >3, pethidine
      25 mg intravenously and Ondansetron 0.1mg/kg was used for cases with nausea or vomiting.
    

Intervention name(s): Piroxicam group; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): patients will receive 0.4 mg/kg piroxicam IM; saline IM in the same dose of piroxicam
Other intervention name(s): piroxicam
Intervention MeSH terms: Piroxicam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: piroxicam; VAS; fractures
A Pilot Study Examining the Efficacy of Biomodulator Treatment for Chronic Low Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this study is to determine the efficacy of self treatment with the
      Biomodulator device to decrease chronic low back pain (LBP) in active duty service members.
      In addition, the study will track the use of pain medication and the impact of pain on
      symptoms of anxiety, depression and Post Traumatic Stress Syndrome (PTSD).
    


Intervention name(s): Biomodulator; Usual Care (Medication + Exercise)
Intervention type(s): Device; Other
Intervention description(s): The Biomodulator is a type of very low frequency TENS known as pulsed electromagnetic field therapy (PEMF). Unlike TENS devices that deliver 1-80 milliamperes of electrical current, PEMF devices deliver short bursts of electrical microamperes (millionths of an ampere) to injured tissues without producing heat or interfering with nerve or muscle function. Micro-current levels between 20-500 microampere appear to be most effective at relieving pain and inflammation and promoting tissue healing by realigning the natural electrical balance that exists within the cells that has become disrupted due to injury.; The study LP will prescribe an analgesic medication regimen based on the participant's needs. These medications may consist of Non-steroidal anti-inflammatory Drugs (NSAIDs) (ibuprofen, naproxen sodium, etc.), muscle relaxants (Flexeril, Robaxin, valium, etc.), non-narcotic analgesic medications (acetaminophen, aspirin, tramadol, etc.), or narcotic medications (Tylenol #3, Percocet, Vicodin, etc.) depending on the severity of their pain and co-morbid conditions. The RC will also provide instructions for LBP stretching and strengthening exercises. The following exercises will be recommended as a daily regimen: the partial curl, cat and camel, pelvic tilt, quadriceps, arm/leg raises,trunk rotation, single knee to chest stretch, standing hamstring stretch, and double knee to chest stretch.
Other intervention name(s): Tennant Biomodulator; Transcutaneous electrical nerve stimulator for pain relief
Intervention MeSH terms: Immunologic Factors; Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: back; pain; chronic
Efficacy Study of AlphaBRAIN Administered Orally
Condition: Cognitive Functioning
Study type: Interventional
Phase: Phase 2

Summary: 
      The manufacturers of AlphaBRAIN(TM) claim that their product, when taken as directed, has
      beneficial effects on cognition. The active ingredient in AlphaBRAIN, Huperzine A, is a
      naturally occurring compound found in firmoss and also thought to be an acetylcholinesterase
      inhibitor. Numerous clinical studies have been undertaken to investigate the effects of
      Huperzine A on cognition and have demonstrated benefit to cognition in both individuals
      diagnosed with neurodegenerative diseases as well as performance on academic tasks by
      students. However, to our knowledge, there are no randomized controlled trials evaluating the
      effects of AlphaBRAIN(TM) on cognition. Thus, the purpose of the current study is to assess
      the effects of daily oral administration of AlphaBRAIN(TM) on cognitive functioning, as
      compared to placebo, after 45 days of treatment.

        1. To evaluate a single daily dose of AlphaBRAIN(TM) vs placebo given orally on the change
           in a battery of standardized neuropsychological tests (see attached).

        2. A secondary objective is to evaluate a single daily dose of AlphaBRAIN(TM) vs placebo
           given orally on sleep.
    


Intervention name(s): AlphaBrain
Intervention type(s): Dietary Supplement
Intervention description(s): Alpha BRAIN® (Onnit Labs LLC) is a multi-ingredient nutritional supplement that purports to enhance cognitive function in healthy adults. The commercially available product contains 12 naturally occurring compounds
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Phase IIa Study of Fomepizole for Acetaldehyde Toxicity After Ethanol Exposure in Subjects With Altered Ethanol Metabolism
Condition: Aldehyde Dehydrogenase-2 (ALDH2) Deficiency
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial will evaluate if fomepizole (4-methylpyrazole) can treat symptoms associated with
      alcohol intolerance due to aldehyde dehydrogenase 2 (ALDH2) deficiency, an inherited
      metabolic disorder. These symptoms include flushing, nausea, headache, shortness of breath
      and dizziness, resulting from exposure to acetaldehyde, the primary metabolite of ethanol.
      Long-term, serious health risks have been associated with repeated exposure to acetaldehyde,
      a carcinogen, among ALDH2-deficient individuals.
    

Detailed description: 
      Approximately 32 subjects will be enrolled in ascending dosing cohorts of 8 subjects each.
      Each subject will receive an oral dose of study drug (fomepizole or placebo) with concomitant
      ethanol with group assignment in a randomized 1:1:1:1 ratio (2 subjects each group) on Study
      Day 1. Each subject is their own intra-subject control with the alternative study drug
      (fomepizole or placebo) administered on the next day (Study Day 2). Four subjects in each
      cohort will receive study drug (fomepizole or placebo) administered 30 minutes prior to
      ethanol, 4 with study drug (fomepizole or placebo) administered 30 minutes after ethanol. The
      study will assess safety and tolerability of fomepizole and the PK/PD of 4-MP, ethanol and
      acetaldehyde in the subject population.
    

Intervention name(s): Antizol; Placebo; Ethanol
Intervention type(s): Drug; Drug; Other
Intervention description(s): oral dose of ethanol (0.5 g/kg)
Other intervention name(s): fomepizole; 4-methylpyrazole; 4-MP
Intervention MeSH terms: Ethanol; Fomepizole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: acetaldehyde; ethanol; ALDH2
Epidemiology and Intervention of Obstructive Sleep Apnea Based on Community
Condition: Sleep Apnea, Obstructive; Hypertension; Obesity; Diabetes; Hyperdiploid; Fatigue Syndrome, Chronic; Insomnia Chronic; Quality of Life; Economic Problems; Compliance, Patient; Health Impairment
MeSH terms: Fatigue Syndrome, Chronic; Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Observational

Summary: 
      This observational study in a real-world community was designed to perform epidemiological
      investigation and assess effect of CPAP intervention of obstructive sleep apnea.
    

Detailed description: 
      Patients with obstructive sleep apnea receiving CPAP or not would be observed in years.
      Primarily Impact of CPAP on health assessment andx control rate of hypertension would
      evaluated.
    

Intervention name(s): Auto-CPAP
Intervention type(s): Device
Intervention description(s): Automatic Continuous Positive Airway Pressure treatment is the first-line treatment of obstructive sleep apnea
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients would be recruited from Community of Huanghua Road.
      
Biospecimen description: 
      Serum lipid, glucose.
    
Keywords: obstructive sleep apnea; real world; community
Hormonal and Metabolic Effects of Weight Loss
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The investigators here propose to evaluate the hormonal and metabolic effects of weight loss,
      including evaluation of changes in several tissues.
    


Intervention name(s): lifestyle
Intervention type(s): Behavioral
Intervention description(s): lifestyle intervention, including diet, physical activity and behavioral changes
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Haematologic Predictors and Clinical Outcome in Cardiac Surgery
Condition: Cardiac Disease
MeSH terms: Heart Diseases
Study type: Observational

Summary: 
      The outcome predictors for cardiac surgery has been popular for many researchers and
      clinicians. Determining risk factors before surgery reduce morbidity and mortality after
      surgery. Some routine blood results have been used as predictors for cardiac surgery but none
      of the researches studied red cell distribution width, mean platelet volume,
      platelet/lymphocyte ratio and neutrophil/lymphocyte ratio. This study focused on these
      parameters and to see whether these parameters can be predictors for cardiac surgery.
    


Intervention name(s): Red red cell distribution width
Intervention type(s): Other
Intervention description(s): Results from hemogram
Other intervention name(s): Mean platelet volume; Platelet/lymphocyte ratio; Neutrophil/lymphocyte ratio
Observational model: Case-Crossover
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        cardiac patients needed cardiac surgery
      
Keywords: cardiac surgery; open heart surgery; hemogram
Effectiveness of Thai Northeastern Folk Musical Therapy for Blood Pressure Control in Hypertensive Patients
Condition: Musical Therapy as a Complementary Treatment of Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      A randomized controlled trial was conducted in a tertiary care hospital, Khon Kaen province,
      Thailand. Sixty participants were randomized to music listening group and control group. The
      music listening group was assigned to listen to 30-minute instrumental folk music everyday
      for one month. Home BP and office BP were monitored and recorded.
    


Intervention name(s): instrumental folk music
Intervention type(s): Other
Intervention description(s): The music was composed and edited by a professor of Folk Musical Department, Faculty of Arts, Khon Kaen University. There were total of 6 songs, 32-minute length. The music was slow-instrumental, 60-80 beats per minute and ranged between 40-60 decibel levels.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised control trial
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: music therapy; hypertension; Asian; stage-2 hypertension
Efficacy Study of "Go On" in Magnetic Resonance Imaging (MRI) Improvement in Osteoarthritis (OA) Knee
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 3

Summary: 
      OA knee is a common degenerative diseases of the joint.

        -  There are many methods to treat this condition.

        -  Hyaluronic acid is one of the recomended treatment of OA knee.

        -  There is no any study on MRI change after injection hyaluronic acid.

        -  The Hypothesis is 25 mg of sodium hyaluronate (2.5 ml) would preserve the joint space in
           patient with osteoarthritis of the knee compared to placebo .
    

Detailed description: 
      This will be the phase III randomized, double-blind, placebo-controlled trial of 52 weeks
      duration designed to evaluate the efficacy of sodium hyaluronate to placebo (saline), in
      adult with OA of the knee joints. Randomization will be stratified by Kellgren-Lawrence(KL)
      grade (garde2 or 3), by subjects X-ray. A total of 60 subjects are planed for enrollment in
      this study. The study will be conducted over approximately 52 weeks.
    

Intervention name(s): 25 mg sodium hyaluronate "GO ON"; normal saline,2 ml., intraarticular weekly for 5 weeks
Intervention type(s): Drug; Drug
Intervention description(s): 25 mg sodium hyaluronate, 2 ml., intraarticular weekly for 5 weeks
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hyaluronic acid,; OA knee,; MRI