bioihbjkbjnl/mcl2 huggingface dataset:
Ibuprofen IV vs Acetaminophen IV for the Treatment of Pain Following Orthopaedic Low Extremity Surgery
Condition: Lower Extremity Problem; Surgery; Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      This study aims to evaluate the efficacy of IV Ibuprofen versus IV Acetaminophen in the
      reduction of pain following orthopedic low extremity procedures
    

Detailed description: 
      Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired
      prior conducting the study. Patients undergoing orthopedic low extremity surgery were
      screened. Eligible subjects were then randomized into treatment group (intravenous ibuprofen)
      and control group (intravenous acetaminophen). In case required, patients from both group
      will be given Morphine (PCA) 1-2 mg every 5 minutes.
    

Intervention name(s): Ibuprofen; Acetaminophen
Intervention type(s): Drug; Drug
Intervention description(s): 800 mg IV - Ibuprofen every 6 hours. In case required - followed with Morphine (PCA) 1-2 mg every 5 minutes; 1000mg IV Acetaminophen every 6 hours. In case required - followed with Morphine (PCA) 1-2 mg every 5 minutes
Intervention MeSH terms: Acetaminophen; Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: ibuprofen; acetaminophen; orthopedic; VAS; morphine; opioid
The Effect Of Tafamidis Meglumine In Transthyretin Amyloid Polyneuropathy Patients
Condition: Transthyretin Amyloid Polyneuropathy (ATTR-PN)
MeSH terms: Polyneuropathies; Amyloid Neuropathies; Amyloidosis
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a single-arm, open-label, multicenter study designed to determine the effect of
      tafamidis meglumine on TTR stabilization as well as tafamidis meglumine safety, tolerability
      and efficacy in ATTR-PN patients in China.

      Approximately 10-15 participants are planned to be enrolled. All enrolled participants will
      receive oral tafamidis meglumine 20 mg soft capsules once daily for 72 weeks (18 months).
    

Detailed description: 
      This is a single-arm, open-label, multicenter study designed to evaluate the efficacy,
      safety, tolerability as well as pharmacodynamics of tafamidis meglumine in ATTR-PN
      participants in China.

      All enrolled participants will receive oral tafamidis meglumine 20 mg soft capsules once
      daily starting on Day 1. Clinical visitswill be scheduled at Baseline (Day 1) and at Week 4,
      Week 8, Week 12, Week 24, Week 48, Week 60 and Week 72. At Week 36 and Week 60 site visit,
      assessment of adverse events, safety related lab testings, concomitant medications and
      investigational product compliance will be scheduled. Every 6 weeks (do not exceed 7 weeks
      since last confirmation) telephone contacts will be made during visits in which no
      investigative site visits are scheduled for assessment of adverse events, concomitant
      medications and investigational product compliance (between Week 12 and 24, between Week 24
      and 36, between Week 36 and 48, between Week 48 and 60, and between Week 60 and 72).
    

Intervention name(s): tafamidis meglumine
Intervention type(s): Drug
Intervention description(s): Tafamidis meglumine 20 mg, once daily, oral administration, for 72 weeks (18 months).
Other intervention name(s): Vyndaqel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tafamidis meglumine
The Effects of a Meditation Retreat on Healthy Volunteers and Cancer Patients: an fMRI Study
Condition: Healthy; Cancer
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effects of a Zen meditation retreat (Sesshin) on
      psychophysiological parameters in healthy volunteers (regular meditators and non-meditators)
      and in cancer patients and to observe possible changes in the attentional circuitry (through
      functional Magnetic Resonance Imaging- fMRI) and in psychological tests (Beck Anxiety and
      Depression Inventories, Self-Compassion Scale, Mindfulness Attention Awareness Scale, Lipp
      Stress Scale for Adults).
    

Detailed description: 
      Meditation results in changes in cognition, sensory perception, affect, hormones, and
      autonomic activity. Until today, there have been very few imaging studies of the neural
      correlates of meditation. Instead of evaluating the meditation practice itself, our approach
      is to evaluate the neural correlates of performance modulation on an attention paradigm (the
      Stroop word-color task; SWCT) and an emotional paradigm (the frustration paradigm) before and
      after a meditation retreat. The following categories of individuals will be invited to
      participate: healthy regular meditation practitioners (at least three years of practice,
      three times a week), individuals inexperienced in meditation, and patients with a cancer
      diagnosis. The total sample will comprise 96 individuals who will be allocated to groups of
      sesshin meditation, rest groups and groups that will keep their daily activities. If they
      wish to do so, those who participate in the two latter groups may also receive training on
      meditation. The subjects will be between 18 and 65 years old and have no contraindication to
      the fMRI exam. After signing an informed consent form, the subjects will answer anxiety,
      depression and stress inventories; scales that evaluate their feelings of self-compassion and
      mindfulness, as well as the Stroop Color Word task and an emotional paradigm of functional
      Magnetic Resonance Imaging.
    

Intervention name(s): Zen meditation
Intervention type(s): Behavioral
Intervention description(s): Zen meditation retreat (7 days: 5 days from 5:30 to 9:30 plus one day for adaptation and the departure day). The program starts everyday at 5:30 and finish at 9:30. In silence, the volunteers perform seating and walking meditation, stretching exercises, eating and all tasks in mindfulness.
Other intervention name(s): Control group: no intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: Meditation; Mindfulness; fMRI; cancer; stress; anxiety; depression; attention; Neuroscience; Neuroimaging; Psychobiology; Healthy volunteers (regular meditators and non-meditators)
A Study of Imlunestrant (LY3484356) in Healthy Women
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the effect of imlunestrant (LY3484356) when
      administered orally on the levels of midazolam in the blood stream in healthy women of
      non-childbearing potential. The study will also evaluate the safety and tolerability of
      imlunestrant in healthy women of non-childbearing potential. This study will last up to
      approximately 6 weeks for each participant including the screening period.
    


Intervention name(s): Midazolam; Imlunestrant
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally.; Administered orally.
Other intervention name(s): LY3484356
Intervention MeSH terms: Midazolam
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Study of Desmoteplase (International Nonproprietary Name [INN]) in Acute Ischemic Stroke (DIAS-2)
Condition: Stroke, Acute
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate desmoteplase (which is a manufactured protein
      derived from the saliva of the vampire bat) in dissolving clots that are blocking the flow of
      blood through one (or more) of the blood vessels supplying the brain, thereby reopening the
      blocked blood vessel and allowing blood to flow again in individuals suffering from ischemic
      stroke.
    


Intervention name(s): Desmoteplase; Desmoteplase; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Desmoteplase 90 mcg/kg, intravenous administration.; Desmoteplase 125 mcg/kg, intravenous administration.; Dose-Match Placebo, intravenous administration.
Intervention MeSH terms: Salivary plasminogen activator alpha 1, Desmodus rotundus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Desmoteplase; Acute Ischemic Stroke; Stroke, Acute
Intranasal Insulin for Weight Management During Smoking Cessation
Condition: Tobacco Abstinence Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This FDA-approved (IND# 120700) study will evaluate efficacy of intranasal insulin in
      reducing snack intake and reducing postprandial free fatty acid levels in abstinent smokers.
    


Intervention name(s): Intranasal Insulin; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Investigation of a Physiotherapist and Nurse Practitioner Intervention for Chronic Low Back Disorders Delivered Through Telehealth
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this project is to compare "usual care" for chronic low back disorders in a
      rural setting (nurse practitioner/NP) to two different means of integrating Physical Therapy
      (PT) into a rural health care team:

        1. in-person PT assessment, where the PT travels from an urban center

        2. interprofessional Telehealth assessment where the local NP is joined by a PT via
           Telehealth.

      The project will evaluate health, systems and process outcomes, comparative effectiveness and
      costs of the three methods of assessment. The hypothesis is that an interprofessional
      Telehealth assessment with be as effective as an in-person PT assessment, but more effective
      than usual care.
    

Detailed description: 
      The study design will include two intervention groups and a control group with 20
      participants in each group: 1. interprofessional videoconferencing intervention, 2. in-person
      PT and, 3. "usual-care" provided by a NP. Due to the interprofessional nature of the
      intervention, the NP involved in the telehealth-based intervention group may alter their
      "usual care" practice; therefore, the control group participants will be drawn from the
      practices of 2 NPs not involved in the Telehealth intervention providing services out of a
      different clinic. Each PT and the NP alone will complete a standardized online diagnostic
      classification tool.Participants will be randomly assigned to one of the three groups.
    

Intervention name(s): NP face to face management of Chronic Low Back Pain; PT face to face management of Chronic Low Back Pain; Interprofessional Videoconferencing for Chronic Low Back Pain
Intervention type(s): Other; Other; Other
Intervention description(s): usual NP management of chronic low back disorder; Includes manual therapy, education, exercise; Includes manual therapy, education, exercise.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: low back pain; telehealth; videoconferencing; access to physical therapy; interprofessional care; rural health
Effects of Finasteride on Serum Prostate-Specific Antigen (0906-111)
Condition: Androgenetic Alopecia
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 3

Summary: 
      A clinical study to collect additional data in order to characterize the reduction in PSA
      with finasteride 1 mg, and its reversibility in men with androgenetic alopecia between the
      ages of 40 to 60 years.
    


Intervention name(s): MK0906, finasteride / Duration of Treatment : 48 Weeks; Comparator : placebo (unspecified) / Duration of Treatment : 48 Weeks
Intervention type(s): Drug; Drug
Intervention MeSH terms: Finasteride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Trial of Miltefosine in Cutaneous Leishmaniasis (Brazil)
Condition: Treatment of Cutaneous Leishmaniasis in Brazil.
MeSH terms: Leishmaniasis; Leishmaniasis, Cutaneous
Study type: Interventional
Phase: Phase 2

Summary: 
      The hypothesis of this trial is that the therapeutic activity and safety of oral miltefosine
      in Brazilian patients with cutaneous leishmaniasis is similar or superior to the intravenous
      standard treatment (meglumine antimoniate - Glucantime®).
    


Intervention name(s): Miltefosine.; Meglumine antimoniate.; Miltefosine.; Meglumine antimoniate.
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Miltefosine: Capsules containing 10 mg or 50 mg miltefosine; administered orally for 28 days at dosage of 2.5 mg/kg body weight per day.; Meglumine antimoniate administered by intravenous route for 20 days at the dosage of 20mg/kg/day.; Miltefosine: Capsules containing 10 mg or 50 mg miltefosine; administered orally for 28 days at dosage of 2.5 mg/kg body weight per day.; Meglumine antimoniate administered by intravenous route for 20 days at the dosage of 20mg/kg/day.
Other intervention name(s): Impavido.; Glucantime.; Impavido.; Glucantime.
Intervention MeSH terms: Miltefosine; Meglumine Antimoniate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cutaneous leishmaniasis; Miltefosine; Meglumine antimoniate; L. braziliensis, L. guyanensis
Characteristics and Clinical Outcomes of Anorexia Nervosa : Siriraj Hospital Experience
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Observational

Summary: 
      This study is aimed to determine clinical characteristics of patients with anorexia nervosa
      and outcome of treatment at Sirirraj Hospital.
    

Detailed description: 
      Data is derived from the medical records
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients of Siriraj Hospital
      
Keywords: Anorexia nervosa; Siriraj Hospital; Thai
Influence of CBD on Episodic Memory in Healthy Subjects
Condition: Healthy
Study type: Interventional

Summary: 
      Placebo controlled, randomized, double blind, cross-over design.

      Single vape of 0.25ml 5% CBD e-liquid (12.5mg CBD) and single vape of 0.25ml e-liquid, tastes
      like lemon and madeleine. 15min vape time each.

      A total of 34 participants, equal number of male and female. There will be replacement of
      Drop-Outs until data from 34 participants are completed.

      The primary endpoint will be performance in a verbal memory task. The secondary endpoint will
      be performance in a working memory test.
    


Intervention name(s): Verum; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single vape of 0.25mL of CBD e-Liquid containing: 5% CBD (low-temperature extracted Cannabidiol from Cannabis sativa L., purity 99%), Glycerine (vegetable), Propylene glycol, water; Single vape of 0.25ml e-liquid La Baronne Jaune, BORDO2.
Other intervention name(s): Cannabidinol (CBD) e-Liquid; e-Liquid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Subcutaneous Immunotherapy Treatment for Patients With Hypersensitivity to Grass Pollen
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Hypersensitivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this trial is to assess the clinical efficacy of the modified extract
      (depigmented and polymerised with glutaraldehyde)of the subcutaneous injection of Phleum
      pratense pollen in the treatment of patients affected by allergic rhinitis/
      rhinoconjunctivitis ( with or without episodic asthma) induced by hypersensitivity to grass
      pollen, evaluating the Score regarding Symptoms and consumption of the medication.
    

Detailed description: 
      Immunotherapy is a specific treatment for allergic diseases. Unlike conventional
      pharmacological treatment, immunotherapy is the only treatment that could modify the natural
      course of allergic disease. This is a prospective double-blind placebo controlled study with
      two arms of treatment in an up-dosing cluster regimen for 4 weeks.
    

Intervention name(s): Allergen extract (Phleum pratense); Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Subcutaneous immunotherapy with modified extract of Phleum pratense. A subcutaneous monthly treatment.; Subcutaneous monthly treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Immunotherapy; Allergoid; Depigmented; Polymerized; Allergen-extract; Rhinoconjunctivitis
Lifestyle and Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The objective of this trial is to determine the effect of different lifestyle interventions
      such as aerobic exercise and alternative resistance training methods, combined with a
      hypocaloric diet, on weight, body composition and metabolic risk factors in overweight and
      obese adults.
    


Intervention name(s): Whole body vibration
Intervention type(s): Other
Intervention description(s): Frequence: 35 Hz Amplitude: 'high' (approx. 4 mm)
Evaluate Effectiveness of the Biomet Lumbar Spinal Fusion System
Condition: Degenerative Disc Disease
MeSH terms: Intervertebral Disc Degeneration
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the effectiveness of the Biomet Lumbar Spinal Fusion
      System in patients undergoing lumbar fusion surgery.
    

Detailed description: 
      All subjects enrolled in this study will receive the The Biomet Osteobiologic Treatment
      System which is comprised of the SpF® Spine Fusion Stimulator and any or all of the following
      can be utilized in the study: any Pedicle Screw System, autograft and an Interbody Spacer
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study is open to all patients with one or two level Degenerative Disease who are
        between the ages of 18 and 75.
      
Keywords: Spinal Fusion; Degenerative Disc Disease
Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Thiazolidinediones or Thiazolidinediones and Metformin
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to compare the effects of twice-daily exenatide plus oral antidiabetic
      (OAD) agents and twice-daily placebo plus OAD with respect to glycemic control, as measured
      by hemoglobin A1c (HbA1c), in patients with type 2 diabetes who experience inadequate
      glycemic control with OAD alone.
    


Intervention name(s): exenatide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): After a 2-week placebo lead-in period (twice daily, given subcutaneously) in addition to their current therapy regimen, subjects will administer 20 mcg of exenatide (2 units [5 μg] ), twice daily by subcutaneous injection, for the first 4 weeks of therapy, and then 40 μL of study drug (4 units [10 μg] of exenatide) twice daily by subcutaneous injection, for the remaining 12 weeks of therapy.; After a 2-week placebo lead-in period (twice daily, given subcutaneously) in addition to their current therapy regimen, subjects will administer placebo (in equivalent amounts to exenatide) for 16 weeks of therapy.
Other intervention name(s): Byetta; AC2993; synthetic exendin-4
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: exenatide; exendin-4; diabetes; Amylin; Lilly
The Parallel Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of CKD-843 A
Condition: Alopecia
MeSH terms: Alopecia
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to evaluate the pharmacokinetics, pharmacodynamics, and safety of CKD-843 A in male
      subjects.
    


Intervention name(s): CKD-843 A 45mg(Multiple dose); CKD-843 A 45mg; CKD-843 A 55mg(Multiple dose); CKD-843 A 55mg; CKD-843-R
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 1 Injection/3 Month, 3 times Injections; Single Injection; 1 Injection/3 Month, 3 times Injections; Single Injection; 0.5mg/day, 9 Month
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Health Effects of Recreational Soccer in Type 2 Diabetic Men
Condition: Type 2 Diabetes; Hypertension; Obesity; Metabolic Syndrome
MeSH terms: Hypertension; Diabetes Mellitus, Type 2; Metabolic Syndrome
Study type: Interventional

Summary: 
      The present study investigates the effects of recreational soccer in type 2 diabetic men in
      regard to muscular, cardiovascular adaptations and glycaemic control. 12 men participate in 6
      month structured recreational soccer training and 10 men act as control with no change in
      lifestyle. Testing consisting of fasting blood samples, muscle biopsies, Dexa-scans,
      echocardiography, maximal oxygen consumption, Yo-Yo interval test, bloodpressure, Resting
      heart rate, and endothelial function (Itamar, Endopat)will be performed at baseline, after 12
      and 24 weeks, respectively.

      The study examines the hypothesis that the high-intensity aerobic work profile combined with
      a high anaerobic turnover from the nature of soccer (accelerations, decelerations, turns,
      sudden stops) will improve glycaemic control, muscle and cardiac function and taken together
      will improve the overall health profile in type 2 diabetic men
    


Intervention name(s): soccer exercise or continued daily lifestyle
Intervention type(s): Other
Intervention description(s): Recreational soccer or continued unchanged lifestyle
Other intervention name(s): Soccer training
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Type 2 diabetes; hypertension; obesity; metabolic syndrome
A Bioequivalence Study of Sanchi-Tongshu Capsule (Enteric Coated Pellets)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      24 healthy male volunteers are to be assigned to take orally Sanchi-Tongshu Capsule (Enteric
      coated pellets) and Sanchi-Tongshu Capsule in fasting condition according to a randomized,
      crossover, self-control method, with ginsenoside Rg1, ginsenoside Re and notoginsenoside R1
      as detection indicators. Establish the "blood drug concentration-time " curve, compare the
      bioequivalence of the main effective ingredients of the two preparations during the
      absorption process in human.
    


Intervention name(s): Sanchi-Tongshu Capsule (Enteric coated pellets); Sanchi-Tongshu Capsule
Intervention type(s): Drug; Drug
Intervention description(s): Take 0.7g (2 Capsules) of test preparation orally.; Take 0.4g (2 Capsules) of reference preparation orally.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)