bioihbjkbjnl/mcl2 huggingface dataset:
Physiological, Behavioral and Subjective Effects of Drugs (GHB)
Condition: Sedative Abuse
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to learn more about the effects of gamma-hydroxybutyric acid
      (GHB) by comparing its physiological, behavioral and subjective effects with those of several
      other drugs.
    

Detailed description: 
      The purpose of this study is to learn more about the effects of gamma-hydroxybutyric acid by
      comparing its physiological, behavioral and subjective effects with those of several other
      drugs.

      This trial will be conducted as a double-blind, double-dummy, placebo-controlled,
      counter-balanced (Latin-square design) crossover study in volunteers with histories of
      sedative abuse. Volunteers will be recruited through advertising and word-of-mouth.

      Volunteers will reside on our residential research unit for the duration of the study and
      participate in a maximum of 16 experimental sessions. Sessions will be conducted five days a
      week (Monday through Friday). The primary subjective and behavioral measures will be taken
      before drug administration and at 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours after drug
      administration.
    

Intervention name(s): sodium oxybate, triazolam and pentobarbital
Intervention type(s): Drug
Intervention description(s): sodium oxybate, triazolam and pentobarbital
Other intervention name(s): Xyrem
Intervention MeSH terms: Sodium Oxybate; Triazolam; Pentobarbital
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: ghb; Xyrem; triazolam; pentobarbital; sedative; abuse
Comparative Study of a Smartphone-Linked Self-Monitoring System Versus a Traditional One for Improving Metabolic Control and Compliance to Self-Monitoring of Blood Glucose
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the superiority of iBGstar as a component of the
      diabetes treatment vs. traditional blood glucose self-monitoring system for improving
      glycemic control after 6 months in young patients with type 1 diabetes. The study is intended
      also to demonstrate the superiority of iBGStar as a component of the diabetes treatment vs.
      usual blood glucose self-monitoring system for improving the compliance to self monitoring of
      blood glucose after 6 months.
    

Detailed description: 
      The planned study duration will be 20 months (5 quarters) with screening/enrollment of 7
      months, followed by 2-3 weeks of a qualification phase, a 6 month experimental phase, plus a
      6 month follow-up in the post-trial observational phase.
    

Intervention name(s): iBGStar; Traditional Glucometer
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Bioavailability of ATI-1501 With Taste Test Sub Study
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      Appili Therapeutics Inc. is developing an oral suspension formulation of metronidazole
      (ATI-1501), a taste-masked reformulation of metronidazole. The purpose of this study is to
      compare the relative bioavailability of ATI-1501 with the Reference Listed Drug (RLD) in
      healthy, adult volunteers to determine that it is Bioequivalent.
    

Detailed description: 
      This is a Phase 1, single-center, randomized, open-label, single dose, 2 sequence, 2
      treatment, crossover, relative bioavailability study of ATI-1501 under fasting and fed
      conditions in healthy adult subjects. The purpose of this study is to determine the relative
      bioavailability of ATI-1501 oral suspension to the comparator drug, Flagyl®. The study also
      aims to evaluate the safety and characterize the PK profile of ATI-1501 oral suspension in
      healthy adults. The PK of ATI-1501 oral suspension in a population of subjects with no
      concomitant illnesses will be recorded and analyzed. Blood samples will be collected through
      individual venipuncture or an indwelling catheter at pre-described time intervals throughout
      the study to determine the bioavailability of ATI-1501 oral suspension and characterize its
      overall PK profile. In addition, blood samples will also be collected using a microsampling
      device to validate the use of blood microsampling for future studies. Subjects will be
      randomized to 1 of 2 treatment sequences and each group of subjects will undergo 4 periods of
      treatment. Each subject will receive each treatment regimen in this crossover study design,
      allowing for a 7-day washout period. The study drugs will be administered under fasting and
      fed conditions to evaluate the effects of food on the absorption of metronidazole,
      administered in the ATI-1501 oral suspension. The palatability of ATI-1501 will be assessed
      using the 9-point scale to assess the taste, texture, and smell of the 2 study drugs. A
      3-point scale will be used to evaluate the degree of bitterness of the 2 study drugs
    

Intervention name(s): Metronidazole Tablet
Intervention type(s): Drug
Intervention description(s): Comparator Drug
Other intervention name(s): Flagyl
Intervention MeSH terms: Metronidazole
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, Open-Label, Single Dose, Two Sequence, Crossover
Masking: None (Open Label)
Primary purpose: Treatment
Effects of TS-134 on Ketamine-induced BOLD Signals in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effects of TS-134 on ketamine-induced BOLD
      signals in ROIs in resting fMRI in healthy adult subjects.
    


Intervention name(s): TS-134; TS-134; Placebo; Ketamine
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): Multiple dose titrations from 10 mg to 20 mg once daily for 6 days; Multiple dose titrations from 10 mg to 60 mg once daily for 6 days; Multiple doses of placebo once daily for 6 days; 0.23 mg/kg bolus over one minute on Screening (baseline) and Day 6
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: TS-134; ketamine; fMRI
Which Place for High Flow Oxygen in ICU ?
Condition: Hypoxemia
MeSH terms: Hypoxia
Study type: Interventional

Summary: 
      Patients with respiratory failure often need oxygen and/or ventilatory support. Patients who
      need only oxygen support, usually received low flow oxygen (< 15 Liters / min), as well as in
      respiratory weaning. Now new devices can be used. They provide high flow oxygen with
      different benefits. This high flow devices provide exact fraction of inspired oxygen (FiO2),
      allows a positive end expiratory pressure and supplies a wash out flow. The hypothesis of
      this study is that the high flow oxygen enable more efficient oxygen administration than
      conventional oxygen. In addition, it would improve the effectiveness of the ventilation of
      the patient, through flushing the dead space.
    

Detailed description: 
      The investigators hypothesized that when using high flow oxygen therapy, respiratory failure
      is relieved, as well as ventilation failure, so accessories are less stressed muscles, and
      this can be demonstrated by the electromyography (EMG) of sterno-mastoid..
    

Intervention name(s): Optiflow
Intervention type(s): Device
Intervention description(s): patients receive oxygen via high flow oxygen therapy during 20 minutes
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: hypoxemia; high flow oxygen therapy; respiratory failure
Whole-body Hyperthermia for Moderate to Severe Depressive Disorder
Condition: Depression, Unipolar
MeSH terms: Hyperthermia; Fever; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The primary aim of this study is to investigate the effectiveness of whole-body hyperthermia
      in addition to standard medical care in comparison to standard medical care alone on
      depressive symptom severity in patients with moderate to severe depressive disorder.

      Secondary aims included further quality of life outcomes, immunological parameters, and
      tolerability/safety of the hyperthermia.
    


Intervention name(s): Whole-body hyperthermia + standard medical care; Standard medical care
Intervention type(s): Combination Product; Combination Product
Intervention description(s): Whole-body hyperthermia will be applied two times during 4 weeks (week 0 and 2 after randomization) in addition to standard medical care. The hyperthermia will be applied using Heckel-HT3000 MPIIb. During the 6 weeks of primary observation, the current medication should be maintained. The dose may be optimized with respect to clinical effectiveness and the reduction of side effects. The type of medication should not be changed during the 6 weeks. The use of additional somatic therapies such as sleep deprivation, light therapy, electroconvulsive therapy, or transcranial magnetic stimulation is not allowed.; Standard medical care included guideline-based anti-depressive drug treatment in combination with psychotherapy. During the 6 weeks of primary observation, the current medication should be maintained. The dose may be optimized with respect to clinical effectiveness and the reduction of side effects. The type of medication should not be changed during the 6 weeks. The use of additional somatic therapies such as sleep deprivation, light therapy, electroconvulsive therapy, or transcranial magnetic stimulation is not allowed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression; Hyperthermia; Randomized Controlled Trial
A Phase 4, Open-label Study to Assess the Feasibility and Efficacy on Motor and Non-motor Symptoms of Switching From Pramipexole or Ropinirole to Rotigotine Transdermal Patch in Subjects With Advanced Idiopathic Parkinson's Disease
Condition: Advanced Idiopathic Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the safety and feasibility of switching subjects with
      advanced Parkinson's Disease (PD) from Pramipexole or Ropinirole to Rotigotine and to assess
      the effects of Rotigotine on motor and non-motor symptoms of Parkinson's Disease in subjects
      switched from previous treatment with either Pramipexole or Ropinirole.
    


Intervention name(s): Rotigotine
Intervention type(s): Drug
Intervention description(s): Rotigotine up to 16 mg / 24 hours, 4 weeks.
Other intervention name(s): Neupro
Intervention MeSH terms: Rotigotine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rotigotine; Neupro; Switch; Dopamine agonists
Cocoa and Endothelial Function in Adults With Elevated BMI
Condition: Cardioprotection
Study type: Interventional
Phase: Phase 1

Summary: 
      Cardiovascular disease is the leading cause of death in the United States. Studies have shown
      that obesity is an important risk factor for development of cardiovascular disease.
      Endothelial dysfunction, a pathologic feature of obesity, predicts the occurrence of
      cardiovascular disease. Recent research findings indicate that consumption of cocoa exerts
      cardioprotective effects, which include increasing HDL levels, reduction in systolic BP,
      inhibition of platelet aggregation/activity and activation of endothelial nitric oxide
      synthase.

      Proposed is a randomized controlled trial consisting of 4 phases designed to examine the
      dose-response, and the acute and sustained effects of cocoa consumption on endothelial
      function as a marker of cardiovascular disease risk in 45 otherwise healthy adults with a BMI
      25-35kg/m2.
    

Detailed description: 
      Endothelial function has been used extensively to evaluate the acute and chronic effects of
      foods and nutrients on cardiac risk and can provide a direct measurement of the effect of
      cocoa powder consumption on vascular physiology in healthy adults with BMI between 25-35
      kg/m2.

      To our knowledge, our study is the first to examine the dose response effects of sugar free,
      liquid, cocoa and solid, dark chocolate with sugar consumption on FMD, concentrating on
      individuals with elevated BMI. Given the current epidemic of obesity in the United States;
      its role as a risk factor in the development of cardiovascular disease; and the fact that
      cardiovascular disease is the leading cause of mortality in this country, examination of the
      cardio-protective effects of cocoa or dark chocolate in an at risk population is of
      considerable potential interest. Demonstrating that ingestion of cocoa may reverse damage
      caused to the endothelium may lead to new dietary recommendations that may help curb the
      prevalence of heart disease in the U.S.
    

Intervention name(s): Chocolate; Chocolate; Chocolate
Intervention type(s): Other; Other; Other
Intervention description(s): 74 grams of single dose solid dark chocolate versus placebo; 22 grams of single dose sugared cocoa, sugar-free cocoa, and placebo; 22 grams of sugared cocoa, sugar-free cocoa, & placebo given for six weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Cocoa; Overweight adults; Endothelial function; Blood pressure; Cardiovascular disease risk; Dark chocolate; Sugar
Effects of Phytoestrogen-rich Diets on Bone Turnover in Postmenopausal Women
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional

Summary: 
      Osteoporosis is a major health problem. It was hypothesized that isoflavone-containing
      products may be a potential alternative to HRT for preventing bone loss during the menopausal
      transition. We investigated whether one-year consumption of isoflavone-enriched foods
      affected bone mineral density, bone metabolism and hormonal status in early postmenopausal
      women in a randomized double-blind, placebo controlled parallel multi-centre trial.
    

Detailed description: 
      Two hundred and thirty-seven healthy early post-menopausal women (age 53 ± 3 y; time since
      last menses 33 ± 15 months) consumed isoflavone-enriched foods providing a mean daily intake
      of 110 mg isoflavone aglycones or control products for 1 yr whilst continuing their habitual
      diet and lifestyle. Outcome measures included bone mineral density of lumbar spine and total
      body, markers for bone formation and bone resorption, hormones, isoflavones in plasma and
      urine, safety parameters and reporting of adverse events.
    

Intervention name(s): Isoflavones-enriched foods
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: early menopause; isoflavones/phyto-estrogens; bone metabolism; bone mineral density; hormones
Using CGM for Evaluating Effects of Food on Glucose Regulation in Healthy Humans
Condition: Glycemic Control; Diet, Food and Nutrition
Study type: Interventional

Summary: 
      The specific goal of this pilot study is to evaluate if it is possible to detect a
      statistical difference in postprandial glycemia after meals served with and without a drink
      previously shown to reduce postprandial glycemia by about 25%. A third drink, with a new
      recipe, is also included for comparisons. Six participants will carry continuous blood
      glucose monitors for 10 days and follow a specific meal schedule. The data from this study
      will form the basis for forming hypothesis of future studies as well as make appropriate
      calculations of statistical power.
    


Intervention name(s): Drinks containing 5AA+CrPic and Placebo
Intervention type(s): Dietary Supplement
Intervention description(s): Same diet will be repeated for 3 days in a row and the beverage switched every day. 3 periods of 3 days are included in the study.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Adult Subjects With Uncontrolled Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      A Multi-center, Double Blind, Randomized, Placebo-controlled, Parallel Group Phase IIa Study
      of MLR-1023 in Adult Subjects With Uncontrolled Type 2 Diabetes
    

Detailed description: 
      Objectives

        1. To assess the safety, tolerability and initial anti-diabetic activity of MLR-1023 in
           subjects with uncontrolled mild to moderate type 2 diabetes mellitus

        2. To evaluate the pharmacokinetics of MLR-1023 and the major metabolite, MLR-1023-M1
           following 28 days of repeat dosing

      Design and Outcomes

      The study is a randomized, double blind, placebo-controlled, parallel group study of MLR-1023
      in adult subjects with uncontrolled type 2 diabetes mellitus who are on diet and exercise
      therapy.

      A subset of subjects per dose group will have additional samples analyzed to measure signs of
      MLR-1023.
    

Intervention name(s): MLR-1023
Intervention type(s): Drug
Intervention description(s): Each subject will receive an oral dose of placebo or MLR-1023 once before breakfast and either placebo (placebo and q.d. dose groups) or a second dose of MLR-1023 (b.i.d. dose groups) before dinner for 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
rTMS for the Treatment of Freezing of Gait in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      This study is a double blind comparative study examining the effectiveness of the rTMS
      treatment on Freezing of Gait (FOG) in patients with Parkinson's disease (PD). The
      investigators hypothesize that treatment with rTMS on supplemental motor area will improve
      gait quality and decrease the frequency of FOG in PD patients.
    

Detailed description: 
      Freezing of gait (FOG) is a common and debilitating symptom in patients with Parkinson's
      disease (PD), characterized by sudden and brief episodes of inability to produce effective
      forward stepping. FOG is a major risk factor for falls, and greatly contributes to reduced
      mobility and quality of daily life. Treatment of FOG has been perceived as a very challenging
      task. Although various treatment approaches exist, including pharmacological and surgical
      options, evidence is inconclusive for many approaches and no clear treatment protocols are
      available until now.

      Repetitive transcranial magnetic stimulation (rTMS), a noninvasive neural modulation
      technique, has been closely applied as a treatment for various neurologic and psychiatric
      disorders. A recent meta-analysis demonstrated that rTMS could improve motor symptoms for PD
      patients with a moderate effect size. To date, however, only few rTMS studies have focused on
      its efficacy on FOG in patients with parkinsonism, and most of them targeted the primary
      motor cortex or dorsolateral prefrontal cortex . Even though some evidence indicates the
      involvement of the SMA in FOG, no report has described the SMA rTMS in PD patients with FOG.

      Moreover, few studies combined functional magnetic resonance imaging (fMRI) and rTMS to
      unravel the mechanism of its beneficial effects. To address these issues, the investigators
      conducted a randomized, double-blind, sham-controlled study to explore the efficiency of
      SMA-rTMS on FOG in PD patients.
    

Intervention name(s): High-frequency rTMS; Sham rTMS
Intervention type(s): Device; Device
Intervention description(s): It is delivered at a 5-second burst of 10Hz stimuli, repeated 20 times at every minute. Each treatment contains a total of 1000 pulses. Stimulus intensity is 90% of resting motor threshold. The SMA stimulation will be given using a coil centered at points 3-cm anterior to the leg motor area in the sagittal midline.; The procedure will be same as the high-frequency rTMS except that the coil is 90° angled away.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: freezing of gait; rTMS; fMRI
Sequential Use of Teriparatide and Raloxifene HCl in the Treatment of Postmenopausal Women With Osteoporosis
Condition: Osteoporosis, Postmenopausal
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether the increase in spine bone mineral density
      that has been generally observed in previous clinical studies involving the study drug can be
      maintained or even increased if followed with raloxifene HCl. All qualifying study
      participants will receive the study drug followed by treatment with raloxifene HCl or
      placebo. All study participants will receive raloxifene HCl in the third phase of the study.
    


Intervention name(s): teriparatide; raloxifene HCl; placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Teriparatide; Raloxifene Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Fluid Management for Cesarean Section
Condition: Cesarean Section
Study type: Interventional

Summary: 
      Cesarean section-associated hypotension is one of the pivotal factors to influence the Apgar
      Score of children and related with the stable hemostasis during the whole process of labor.
      How to keep circulation in a consistent stability is yet to be known. The investigators
      hypothesized that different fluids, crystalloids or colloids, can produced varying effects in
      keeping the physiological environment of labor from significant fluctuating.
    


Intervention name(s): Ringer's Lactate; 6% Starch
Intervention type(s): Other; Other
Intervention description(s): Ringer's Lactate was used 15min before operation; 6% Starch was used 15min before operation
Other intervention name(s): RL; ST
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Regional anesthesia; Fluid Therapy; Hemostasis, Surgical
Radiation Exposure in Spine Intervention Under Angiography
Condition: Low Back Pain
MeSH terms: Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluate radiation exposure and procedure times for continuous fluoroscopic monitoring during
      lumbar ESI
    

Detailed description: 
      The purpose of this prospective study was to evaluate radiation exposure and procedure times
      for fluoroscopic monitoring during lumbar ESI with analyzing the differences among operators
      (experienced staff and trainee) and among different method for ESI.
    

Intervention name(s): Epidural steroid injection
Intervention type(s): Radiation
Intervention description(s): Epidural steroid injection
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment