bioihbjkbjnl/mcl2 huggingface dataset:
Hybrid Model of Vocal Inflammation and Tissue Mobilization
Condition: Acute Phonotrauma
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to generate a technology that will allow clinicians to prescribe
      behavioral treatment that should optimize tissue healing for both acute and chronic
      phonotrauma. In this study, we propose to (1): establish a non-invasive methodology for
      estimating overall mechanical dose during phonation, and component metrics of phonatory
      mechanical dose (e.g., distance dose, energy dissipation dose and time dose) from high speed
      imaging data and aeromechanical modeling, for a range of vocal fold configurations
      (Experiment 1); (2): identify mathematical relations between treatment dose parameters,
      inflammatory state of the tissue and time-varying biological consequences in the tissue, up
      to 2 wk following acute phonotrauma (Experiment 2); (3): develop a hybrid physical-biological
      model of vocal fold inflammation and treatment to identify treatment modalities that should
      optimize post-traumatic wound healing at 2 wk, for a range of acute phonotraumatic conditions
      (Experiment 3-no human subject involved), and (4): provide a preliminary test of the hybrid
      treatment models' ability to predict idealized treatment outcome in human subjects, and
      calibrate the model as needed iteratively to achieve a match between predicted and obtained
      outcomes (Experiment 4).
    


Intervention name(s): resonant voice; voice rest; Breathy voice; Relaxation exercise; Resonant voice and relaxation exercise
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): A 4-hr resonant voice exercise will be prescribed to subjects following vocal loading.; A 4-hr voice rest will be prescribed to subjects following vocal loading.; A 4-hr breathy voice exercise will be prescribed to subjects following vocal loading.; A 4-hr relaxation exercise will be prescribed to subjects following vocal loading.; A 4-hr resonant voice and relaxation exercise will be prescribed to subjects following vocal loading.
Other intervention name(s): meditation; Resonant voice and meditation exercise
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: acute phonotrauma; computer modeling; resonant voice; breathy voice; voice rest; relaxation
Study of Hepatic Glucose Production and De Novo Lipogenesis in Patients With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Observational

Summary: 
      OBJECTIVES:

      I. Determine the amount of hepatic glucose production derived from gluconeogenesis and
      glycogenolysis in the post-absorptive state in patients with cystic fibrosis.

      II. Determine de novo lipogenesis in relationship to resting energy expenditure in this
      patient population.
    

Detailed description: 
      PROTOCOL OUTLINE:

      Patients undergo an oral glucose tolerance test (OGTT) in which blood is drawn from an IV in
      the arm 6 times over 3 hours. After the first blood draw, patients receive a beverage
      containing sugar and write down everything they ate and drank during the 24 hours before
      study entry. Patients also undergo a dual energy x-ray absorptiometry (DEXA) scan over 15
      minutes.

      Within 2 weeks after the OGTT, patients keep a journal of everything they ate and drank over
      3 days. Patients are fed a selected meal the following evening and receive saline fluids IV
      overnight. During the night, patients receive 2 doses of oral doubly labeled water. The next
      morning, patients receive [1,2-13C]acetate IV. A liquid mixed meal (Ensure Plus) is ingested
      hourly throughout the day. Patients also undergo hood indirect calorimetry over 30 minutes
      twice to measure resting energy expenditure. All urine is collected.
    

Keywords: cardiovascular and respiratory diseases; cystic fibrosis; genetic diseases and dysmorphic syndromes; rare disease
The Prevalence of Osteoporotic Vertebral Compression Fractures (OVCF) in Korean Post Menopausal Women
Condition: Osteoporosis, Postmenopausal
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal; Fractures, Compression
Study type: Observational

Summary: 
      This is an observational study to investigate the prevalence of osteoporotic fractures in
      post menopausal patients. Post menopausal patients who visit OS(orthopedic surgery) including
      GHs(general hospitals) and clinics will be enrolled.
    

Detailed description: 
      This is an observational study to investigate the prevalence of osteoporotic fractures in
      post menopausal patients. Post menopausal patients who visit OS(orthopedic surgery) including
      GHs(general hospitals) and clinics will be enrolled. They will take the evaluation of spine
      X-ray and answer to a few questions. Their medical record will be reviewed and relevant
      clinical findings will be collected.
    

Intervention name(s): Fracture evaluation
Intervention type(s): Other
Intervention description(s): DEXA(Dual-energy X-ray absorptiometry), X-ray
Other intervention name(s): X-ray
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Postmenopausal women
A Multiple Dose Study of DWP10292 and UDCA in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and
      pharmacodynamics of DWP10292 and UDCA in healthy male volunteers after multiple-dosing.
    

Detailed description: 
      This study is dose block-randomized, double-blind, placebo controlled, multiple-dosing, dose
      escalation clinical trial to investigate the safety, tolerability and pharmacokinetic
      characteristics of DWP 10292 after oral administration in healthy male subjects.
    

Intervention name(s): DWP10292; DWP10292 Placebo; Ursodeoxycholic acid (UDCA); UDCA Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Drug: DWP10292 tablets, oral administration, multiple administration; Placebo tablets, oral administration, multiple administrations; Drug: Ursodeoxycholic acid (UDCA) tablets, oral administration, multiple administration; Placebo tablets, oral administration, multiple administrations
Intervention MeSH terms: Ursodeoxycholic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
A Study of LY3108743 in Healthy Participants and Participants With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the safety and tolerability of the study drug
      known as LY3108743 in healthy participants and in participants with type 2 diabetes.

      The study will also investigate how LY3108743 affects the levels of blood sugar and other
      naturally occurring substances (e.g. hormones that control the way sugar is used) in the
      body, how much of the study drug gets into the blood stream, and how long it takes the body
      to get rid of it.

      Information about any side effects that may occur will be collected. The study is expected to
      last approximately 7 to 8 weeks for each participant.

      The study will have up to 3 parts. Participants may enroll in only one part.
    


Intervention name(s): Placebo - Capsule; LY3108743 - Capsule; Placebo - Solution; LY3108743 - Solution
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered orally; Administered orally; Administered orally; Administered orally
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Effects of Different Postures and Ventilator Flow Waveforms on the Cuff Leak Test
Condition: Cuff Leak Volume
Study type: Observational [Patient Registry]

Summary: 
      the purpose of this study is to analyzes the factors influencing the results of cuff leak
      test, in order to improve the cuff leak test on the accuracy of the prediction on airway
      edema after extubation.
    


Intervention name(s): Position, waveform
Intervention type(s): Behavioral
Intervention description(s): different positions and waveform
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients in RICU of Beijing chaoyang hospital with tracheal intubation
      
Keywords: Cuff leak test, relative factors
CD71 in Dried Blood Spots in Healthy Males
Condition: Healthy Athletes
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Understand the effect of recombinant EPO (rEPO) boosting and microdosing on the hematological
      module of the Athlete Biological Passport (ABP)

        -  Measure the change in CD71 longitudinally in subjects from both cohorts

        -  Assess whether rEPO administration can be detected in a dried blood spot (DBS) using
           recent advances in analytical methodologies

        -  Compare windows of rEPO detection using both Athlete Biological Passport models and
           direct detection using analytical methods in urine, blood, and DBS
    

Detailed description: 
      Despite being banned by the World Anti-Doping Agency, blood doping is a common method of
      performance enhancement used by athletes wishing to gain an unfair advantage over their
      competition. A common way to achieve this increase is by using erythropoiesis stimulating
      agents (ESA's), namely recombinant erythropoietin (rEPO). Though laboratory tests have been
      developed for the direct detection of all known isoforms of exogenously administered ESAs in
      both urine and blood, athletes have found ways to circumvent these testing measures using
      techniques such as microdosing.
    

Intervention name(s): EPOGEN® (epoetin alfa); Normal Saline
Intervention type(s): Drug; Other
Intervention description(s): Active drug; Placebo
Other intervention name(s): erythropoietin, rEPO; Saline
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Cohort A to receive active drug Cohort B to receive placebo, (saline)
Masking: Single (Participant)
Primary purpose: Other
Initiate and Maintain Physical Activity in Clinics: The IMPACT Diabetes Study
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The Initiate and Maintain Physical Activity in Clinics (IMPACT) study will determine the
      optimal and feasible level of frequency of structured contact needed in a clinical setting
      for adult patients with Type 2 Diabetes Mellitus to initiate and maintain physical activity
      recommendations long-term.
    

Detailed description: 
      The IMPACT Study will compare the health outcomes and lifestyle habits amongst the three
      groups of study participants. Study participants will be randomized into three exercise
      group. Group 1 will participate in instructor-led exercise training sessions 1 time per week,
      for 24 weeks (approximately 6 months). Group 2 will participate in instructor-led exercise
      training sessions 3 times per week, for 24 weeks (approximately 6 months). Group 3 will not
      attend any instructor-led exercise training sessions. All groups will be encouraged to see
      their usual providers for routine healthcare, and continue their usual medication regimen.
    

Intervention name(s): Structured Group Exercise
Intervention type(s): Behavioral
Intervention description(s): The study intervention is a 6-month exercise program with structured group sessions conducted in a clinical setting. Group sessions include Aerobic Training and Combined Training. Once-Weekly participants will attend one Combined Training session while thrice-weekly participants will attend two Combined Training sessions and one Aerobic Training session per week. Participants in both groups will attend three exercise evaluations during the intervention period. Participants will also use provided logs to track their daily exercise activities outside of group sessions. Physical activity will be assessed by group session attendance, exercise resistance and intensity, and exercise frequency data collected from exercise logs, surveys, and evaluations.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Physical Activity
Effects of Increased Muscle Mass on Resting Metabolic Rate
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      Healthy males are randomized to isometric exercise for three months with either extra protein
      or extra calories in the form of a fast food meal/day in order to study if increase in muscle
      mass increases resting metabolic rate and if this is affected by presumed increased caloric
      intake as compared with only proteins.

      Body-composition was measured with Dual-Energy X-ray Absorbimetry (DEXA) and RMR was measured
      by registration of CO2 production and O2 consumption.
    


Intervention name(s): Isometric exercise
Intervention type(s): Procedure
Intervention description(s): Isometric exercise several times/week for three months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: resting metabolic rate
A Safety Study of ARRY-502 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 study, involving a 14-day dosing period, designed to test the safety of
      investigational study drug ARRY-502 in healthy subjects. Approximately 32 healthy subjects
      from the United States will be enrolled in this study.
    


Intervention name(s): ARRY-502; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral; multiple dose, escalating; Oral; matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Safety
Testosterone Treatment for Hypogonadal Men
Condition: Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 3

Summary: 
      Demonstrate efficacy and safety of Testosterone Gel 1.62% for the treatment of hypogonadal
      men
    


Intervention name(s): Testosterone (T) Gel 1.62%; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Testosterone gel 1.62% contains 1.62% testosterone gel as active ingredient.; Placebo Control
Intervention MeSH terms: Testosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hypogonadism; Testosterone Deficiency
Study to Test the Safety of HPV Vaccine in Women (V501-011)(COMPLETED)
Condition: Cervical Cancer; Genital Warts
MeSH terms: Condylomata Acuminata
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of the study is to test the safety of HPV Vaccine in Women
    


Intervention name(s): V501, Gardasil, Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine / Duration of Treatment : 4 Years; Comparator: placebo (concomitant-vaccine matched) / Duration of Treatment : 4 Years
Intervention type(s): Biological; Biological
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Clinical Observation of Ningmitai Capsule in Treating Chronic Pelvic Pain Syndrome With Erectile Dysfunction
Condition: Chronic Prostatitis With Chronic Pelvic Pain Syndrome; Erectile Dysfunction
MeSH terms: Erectile Dysfunction; Prostatitis; Syndrome; Pelvic Pain; Somatoform Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Objective: The purpose of this study was to evaluate the clinical efficacy and safety of
      Ningmitai capsule alone or in combination with sildenafil compared with sildenafil alone in
      the treatment of CP/CPPS with erectile dysfunction.

      Study Design: A multicenter, prospective, randomized and positive drug-controlled clinical
      study design was adopted.

      Interventions:

      ① Western medicine group (sildenafil): Sildenafil citrate, 25mg/capsule, once a night, one
      capsule each time, for 4 weeks.

      ② Chinese medicine group (Ningmitai capsule): Ningmitai capsule, 0.38 g/capsule, 3 times a
      day, 4 capsules each time, taken after meals for 4 weeks continuously.

      ③ Combination group (Ningmitai capsule + sildenafil): Ningmitai capsule, 0.38 g/capsule, 3
      times a day, 4 capsules each time, taken after meals; Sildenafil citrate, 25mg/capsule, once
      a night, one capsule each time, was taken continuously for 4 weeks.
    

Detailed description: 
      Sample size: 214
    

Intervention name(s): Sildenafil; Ningmitai capsule; Ningbitai capsule + sildenafil
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects were given sildenafil citrate, 25mg/capsule, once a night, one capsule each time, for 4 weeks.; The subjects took Ningmitai capsule, 0.38 g/capsule, 3 times a day, 4 capsules each time, after meals, and continued to treat for 4 weeks.; The subjects took Ningmitai capsule orally, 0.38 g/capsule, 3 times a day, 4 capsules each time, and took it after meals. Sildenafil citrate, 25mg/capsule, once a night, one capsule each time, was taken orally for 4 weeks.
Other intervention name(s): Western Medicine Section; Traditional Chinese medicine group; Combined group
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ningmitai capsule; Sildenafil; Chronic prostatitis/chronic pelvic pain syndrome; Erectile Dysfunction
Myofascial Trigger Points of the Levator Scapulae Muscle
Condition: Myofascial Pain Syndrome
MeSH terms: Myofascial Pain Syndromes; Fibromyalgia
Study type: Interventional

Summary: 
      Chronic neck pain (CNP) is considered one of the most common musculoskeletal disorders
      worldwide and myofascial pain syndrome (MPS) is the most prevalent musculoskeletal disorder
      in the majority of the population. However, normal tissue contractility changes and the
      different types of myofascial trigger points (MTrPs) measured by tensiomography have not yet
      been studied. For this reason, the aim of our study is to determine the differences in
      pressure pain threshold (PPT), tensiomyography and sonoelastography between the palpation
      zone of control points with respect to active and latent MTrPs in the levator scapulae
      muscles of subjects with CNP. A single-blind descriptive cross-sectional study is conducted
      with a convenience sample of 60 points (20 active, 20 latent and 20 control points) on both
      sides of the subject in the levator scapulae muscles of individuals diagnosed with CNP.

      The order of outcome measurements for each point was PPT, manual tension index
      sonoelastography and tensiomyography separated by 15 minutes. Objective contractile
      parameters were: contraction time (Tc), mean relaxation time (Tr), maximum radial
      displacement (Dm), holding time (Ts) and delay time (Td).
    


Intervention name(s): Sonoelastography, tensiomyography and mechanosensitivity
Intervention type(s): Diagnostic Test
Intervention description(s): To observe the differences between the different trigger points of the levator scapulae muscle by means of different diagnostic options.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Health Services Research
Keywords: physiotherapies techniques; sonoelastography;; muscle tension; neck pain
A Study to Determine the Abuse Potential of Seltorexant Compared to Suvorexant and Zolpidem
Condition: Healthy Non-dependent, Recreational Sedative Users; Abuse Potential
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the abuse potential of seltorexant compared to
      placebo and two active comparators (zolpidem and suvorexant) in non-dependent, recreational
      sedative users.
    


Intervention name(s): Suvorexant; Zolpidem; Seltorexant; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Suvorexant will be administered orally as per assigned treatment sequence.; Zolpidem will be administered orally as per assigned treatment sequence.; Seltorexant will be administered orally as per assigned treatment sequence.; Placebo will be administered orally as per assigned treatment sequence.
Other intervention name(s): JNJ-42847922
Intervention MeSH terms: Zolpidem; Suvorexant
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
K301 for the Treatment of Seborrhoeic Eczema (SE) of the Scalp
Condition: Seborrhoeic Eczema of the Scalp
MeSH terms: Eczema; Dermatitis, Seborrheic
Study type: Interventional
Phase: Phase 3

Summary: 
      Seborrhoeic eczema (SE) is a chronic, inflammatory skin disorder confined to areas of the
      head and trunk where sebaceous glands are most prominent. The severity varies from mild
      dandruff to exfoliative erythroderma that ranges from mild, patchy scaling to widespread, and
      thick, adherent crusts. The worldwide prevalence of SE is 3-5%, although dandruff, the
      mildest form of the disorder affects up to 15-20% of the population.

      In this multicentre, randomised, double-blind, placebo-controlled phase III study, adult SE
      patients are treated once daily for 4 weeks. The population for this study is patients with
      mild to moderate SE.

      The primary endpoint for this study is the efficacy of K301 compared to placebo which was
      based on the sum score for erythema and desquamation after 4 weeks of daily application.
      Secondary endpoints are to evaluate safety and tolerability as well as efficacy.
    


Intervention name(s): K301; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Liquid- applied once daily prior to bed; Liquid- applied once daily prior to bed
Other intervention name(s): K40
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: seborrhoeic eczema; scalp; dandruff; K301; K40