bioihbjkbjnl/mcl2 huggingface dataset:
Measurement of Retinal Venous Pressure in Chronic Low-oxygen Environment
Condition: Healthy
Study type: Observational

Summary: 
      The hypothesis is that the pressure in the retinal veins increases from chronic lack of
      oxygen and leads to decreased blood flow. On the basis of high altitude mountaineering this
      hypothesis should be verified. At the same time the adaptation capacity of the blood
      circulation should be analyzed, and a relationship to mountain sickness should be found.
    

Detailed description: 
      Conduct a field study to describe and quantify the retinal venous pressure (RVP) in healthy
      volunteers under conditions of controlled chronically reduced ambient pressure and oxygen
      partial pressure in the mountains. Obtaining indications regarding the adaptation of the
      retinal vascular system behavior to controlled, long-term hypoxic changes. Comparisons with
      blood pressure, pulse, oxygen saturation level and the appearance of symptoms of acute
      mountain sickness are made in order to obtain a better understanding of the development of
      high altitude illness.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        healthy volunteers
      
Keywords: retinal venous pressure (RVP); chronically reduced ambient pressure; oxygen partial pressure; mountain sickness
Community Health Worker Diabetes Prevention Intervention
Condition: Diabetes Prevention
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The primary goal of this study is to develop, implement, and test a community health worker
      (CHW) program designed to promote diabetes prevention among Korean and South Asian Americans
      in New York City.

      In particular, the specific aims of this study are:

        1. To utilize community based participatory research (CBPR) methods to expand upon an
           existing campus-community partnership to develop and implement a CHW program among
           Korean and South Asian Americans that promotes diabetes prevention;

        2. To develop, implement, and assess the efficacy of a CHW intervention to promote diabetes
           prevention and access to care among NYC Koreans and South Asians.
    


Intervention name(s): Educational group trainings; Community Health Care Worker
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will receive 6 two and a half hour educational group training's over the course of 6 months. These sessions will be led by a trained CHW in your language and will be held on a monthly basis in a community based location.
Session 1: What is Diabetes
Why is Prevention Important
Session 2: Nutrition Session 3: Physical Activity Session 4: Cardiovascular Disease & Diabetes Complication Session 5: Stress Management Session 6: Access to Service; A community health care worker answer your questions about diabetes and refer participant to a physician. Survey will be completed at the start of the study and during the 3rd, 6th and 12th months
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Primary purpose: Prevention
Keywords: Diabetes Prevention
Impact of Hot Flashes on Sleep and Mood Disturbance
Condition: Menopause; Depression; Hot Flashes
MeSH terms: Hot Flashes
Study type: Interventional
Phase: Phase 4

Summary: 
      We plan to enroll premenopausal women in a trial investigating the impact of hot flashes
      developed in response to an injection of a gonadotropin-releasing hormone agonist (GnRHa),
      leuprolide (brand name: Lupron), on sleep disruption and mood. This study is designed to
      mimic the menopause transition. We will collect data on sleep disruption and mood changes to
      assess their relationship to the development of hot flashes.
    


Intervention name(s): leuprolide
Intervention type(s): Drug
Intervention description(s): Leuprolide acetate is a widely used GnRH agonist. In this protocol, leuprolide will be administered at a dose routinely used for treatment of endometriosis and uterine fibroids in women (one 3.75-mg intramuscular injection).
Other intervention name(s): Lupron
Intervention MeSH terms: Leuprolide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Hot Flashes; Sleep disturbance; Lupron; Menopause
Efficacy and Safety of FTY720 in Patients With Relapsing Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluated the safety, tolerability and effect on MRI lesion parameters of FTY720
      in patients with relapsing multiple sclerosis.
    


Intervention name(s): FTY720; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): FTY720 capsule was taken orally once a day; Placebo 1.25 mg capsule was given once daily
Intervention MeSH terms: Fingolimod Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: FTY720; MS; Multiple Sclerosis; RRMS
Evolution of Food Orality in Children Aged Between 24 and 36 Months: Comparison of the Severity and Specificities of Disorders Between Two Populations of Children, Born Very Prematurely and Born at Term
Condition: Infant, Premature, Diseases
MeSH terms: Infant, Premature, Diseases
Study type: Observational

Summary: 
      Oral disorders are currently widely described in the premature birth population, but few
      studies compare them to their prevalence in the full-term population.

      In addition, new behaviours and eating habits are regularly emerging in our society.

      The objective of this study is to compare the severity of signs of oral disorders between the
      group of preterm infants and the group of term infants born without organic pathologies that
      compromise oral development.
    


Intervention name(s): Archet scale
Intervention type(s): Behavioral
Intervention description(s): Parents will be asked to answer questions about their child's nutrition by using a new scale : Archet scale
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        term and prematurely born child
Metabolic Effects of Cocaine
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional

Summary: 
      The goal of this this study is to elucidate the role of the HPA axis in the pathophysiology
      of cocaine dependence
    


Intervention name(s): cocaine; hydrocortisone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Hydrocortisone; Cocaine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Keywords: craving, insulin, leptin
Tolerability and Efficacy of AM and PM Once Daily Dosing With Extended-release Guanfacine Hydrochloride in Children 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD) (The ADHD Tempo Study)
Condition: Attention-Deficit/Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose is to assess the efficacy of once daily dosing with optimized SPD503 (1,
      2, 3 and 4mg/day), dosed either in the morning or evening, compared to placebo, in children
      with ADHD as measured by change from baseline score at endpoint on the ADHD-RS-IV.
    


Intervention name(s): extended-release guanfacine hydrochloride (SPD503); placebo; extended-release guanfacine hydrochloride
Intervention type(s): Drug; Drug; Drug
Intervention description(s): dosed in AM; dosed in the AM or PM; Dosed in the PM
Other intervention name(s): Intuniv; Intuniv
Intervention MeSH terms: Guanfacine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD
Dose Ranging Study in Healthy Methadone Maintenance Subjects
Condition: Adult
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the effect of a single oral dose of MOA-728, an investigational drug, on the
      oral-cecal transit time in subjects who are taking methadone.
    


Intervention name(s): MOA-728
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Posttraumatic Neuralgia..
Condition: Nerve Pain
MeSH terms: Neuralgia
Study type: Interventional
Phase: Phase 2

Summary: 
      A study to investigate the analgesic efficacy of AZD2423 compared with placebo after 28 days
      treatment in patients with posttraumatic neuralgia.
    


Intervention name(s): AZD2423; AZD2423; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 20 mg tablet; 50 mg tablet; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Analgesic effect
Pharmacokinetic Interaction Study of Dapoxetine 30mg and Mirodenafil 50mg
Condition: Drug Interaction Potentiation
Study type: Interventional
Phase: Phase 1

Summary: 
      Healthy male volunteers were administered alone and in combination with dapoxetine 30mg
      mirodenafil 50mg for three times, respectively and the pharmacokinetic interaction was
      compared between the two drugs.
    


Intervention name(s): Dapoxetine 30mg tablet; Mirodenafil 50mg tablet
Intervention type(s): Drug; Drug
Intervention MeSH terms: Mirodenafil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dapoxetine; Mirodenafil; DDI study
Radiation Dosimetry, Metabolism, Pharmacokinetics, Safety and Tolerability and PET Imaging With BAY94-9392 in Healthy Volunteers and Patients With Cancer or Inflammation
Condition: Diagnostic Imaging; Neoplasms
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography)
      images obtained after a single intravenous injection of BAY94-9392 in patients with cancer or
      inflammation.
    


Intervention name(s): BAY94-9392
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Neoplasm; PET/CT diagnosis; PET tracer
A Relative Bioavailability Study of a Fixed Dose Combination (FDC) Tablets of GSK587323
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is required to confirm the suitability of a candidate FDC of 16mg candesartan
      cilexetil/12.5mg HCTZ (GSK587323) formulation for further development and provide data to
      allow the design of a future pivotal bioequivalence study. This study aims to determine the
      relative bioavailability of a FDC tablet formulation of 16mg candesartan cilexetil/12.5mg
      HCTZ relative to the reference product of same fixed dose combination (16mg candesartan
      cilexetil/12.5mg HCTZ) in healthy adult humans. This will be an open-label, randomised,
      single dose, two-way crossover study. Each subject will participate in two treatment periods
      and will be randomized to one of two sequences and administered one of the two treatments, A
      or B, as per the randomization schedule. The two treatment periods will be separated by a
      washout period of 7 to 14 days to ensure the candesartan and HCTZ have been effectively
      eliminated from the subject between dosing occasions. The study will enroll 16 healthy
      subjects to ensure that 14 subjects complete the study as planned.
    


Intervention name(s): GSK587323; FDC of candesartan cilexetil 16 mg and HCTZ 12.5mg
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of FDC tablet formulation to be taken orally.; Single dose of FDC tablet formulation to be taken orally
Intervention MeSH terms: Candesartan; Candesartan cilexetil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Candesartan cilexetil; Hypertension; Hydrochlorothiazide; Healthy adult human subjects; Bioequivalence
Augmented Reality and Treadmill Training After Traumatic Brain Injury
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional

Summary: 
      Up to 40 participants will be enrolled in this study in order to obtain complete data on 30
      participants. The investigators will be assessing if Augmented reality in combination with
      treadmill training is safe and feasible to use in the clinical environment with participants
      who have chronic TBI and if there is a signal of effect that this intervention may be more
      beneficial than treadmill training alone or standard of care.
    


Intervention name(s): Augmented Reality; Treadmill training; Over ground training/standard of care
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Augmented Reality (AR) systems are computer-based applications that allow an individual to view a simulated environment and dynamically interact within this environment in real-time. Augmented reality activities will be chosen by the therapist based on the primary deficits assessed during baseline testing.; The goal of each session will be to increase balance and mobility challenge by increasing speed and minimizing BWS. Appropriate BWS will be chosen at the beginning of each training session. Participants will walk for 1 minute on the treadmill at 30%, 20% and 10% BWS. Maximum walking speed will be determined at each level of BWS and the participant will spend the remainder of the session ambulating with BWS at which they were able to achieve maximum walking speed. Additional BWS will be provided up to 30% of the participant's total body weight if the treating therapist identifies safety concerns or unfavorable gait kinematics. If a safe and kinematically appropriate gait pattern is unable to be achieved at up to 30% BWS, the previously determined walking speed will be reduced to achieve a safe and appropriate walking pattern. Participants will be encouraged not to use upper extremity support while ambulating with BWS.; Standard of care interventions to address balance and mobility deficits will be chosen from a list of commonly used interventions in outpatient therapy. The goal of each session will be to increase balance and mobility challenge in an over ground condition focusing treatment in the following areas:
Biomechanical Constraints
Stability Limits
Anticipatory Postural Adjustments
Reactive Postural Response
Sensory Orientation
Stability in Gait
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Turkish Validation Study of Endometriosis Health Profile -30 (EHP-30) Test
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Observational

Summary: 
      For the Turkish validation Study of the Endometriosis Health Profile test (EHP-30) consisting
      of 30 questions, this 30-question test will be applied to 228 patients after 2 different
      translations to be applied after the translation of this 30-question test sworn translator to
      the patients who have been surgically diagnosed with endometriosis.
    

Detailed description: 
      The appointment of the patients consists of patients who were surgically diagnosed with
      Endometriosis in our clinic. English and Turkish translation will be verified after 2
      different sworn translators.
    

Intervention name(s): Endo Patients with Endometriosis Health Profile -30 (EHP-30) Test
Intervention type(s): Other
Intervention description(s): The appointment of the patients consists of patients who were surgically diagnosed with Endometriosis in our clinic.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Female patients between the ages of 18-45 who were surgically diagnosed with endometriosis
        in our clinic will be included in the study. Persons with a known psychiatric illness,
        pregnant or using anti-depressant medication will be excluded from the study. Patients will
        be asked the questions of the online EHP-30 form and the answers given will be evaluated in
        terms of validation.
Effects of Anesthetic Methods on Hepatic Cancer Cell Malignancy
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Liver Neoplasms
Study type: Interventional

Summary: 
      Numerous studies found that anesthetic methods can influence the recurrence of tumor and the
      overall survival of patients after primary cancer surgery. Radiofrequency (RF) ablation is
      now widely used in clinic for treatment of hepatocellular carcinoma (HCC). Currently, diverse
      anesthetic methods, including general anesthesia (GA), epidural anesthesia and local
      anesthesia (LA), are used for RF ablation surgery. Using serum from HCC surgery patients
      randomized to receive either GA or LA during surgery, we investigated the effects of
      anesthetic methods on proliferation, migration and metastasis in HepG2 hepatic cancer cells
      in vitro.
    


Intervention name(s): anesthetic methods
Intervention type(s): Procedure
Intervention description(s): Patients will receive standard GA or LA for RF surgery.
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Energy Conservation Technique in COPD Patients
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Chronic obstructive pulmonary disease (COPD) is characterised by non-reversible bronchial
      obstruction associated with systemic disorders and comorbid factors. Dynamic hyperinflation
      during an exercise increase dyspnea and can reduce exercise capacity. Stair climbing is
      associated with prolonged dynamic hyperinflation and severe dyspnea in COPD patients. The aim
      of this study is to carry out the effect of an energy conservation technique on dyspnea to
      facilitate stair climbing.
    


Intervention name(s): energy conservation technique; control session
Intervention type(s): Other; Other
Intervention description(s): During the session of stair climbing, patients will perform a break at least of 5 seconds every 3 steps.; Patients will realize one session of stair climbing at their own pace
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Patients will perform two stair climbing sessions (each session include 108 steps) under two different conditions on the same day with at least 30 minutes of rest between the two sessions.
the order of the two conditions will be randomly assigned
Masking: None (Open Label)
Primary purpose: Other
Keywords: COPD; daily activity; stair climbing; rehabilitation
Study To Determine The Effects And Safety Of A Weight Loss Compound On Overweight, Otherwise Healthy, Volunteers
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether CP-866,087 is effective in the weight loss
      of overweight patients.
    


Intervention name(s): CP-866,087; CP-866,087; CP-866,087; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1 mg of CP-866,087, administered QD for 84 days; 5 mg of CP-866,087, administered QD for 84 days; 10 mg of CP-866,087, administered QD for 84 days; placebo administered QD for 84 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Obesity, weight loss
Intramedullary Resorbable Fixation System Versus K-wire for the Treatment of Lesser Toe Deformities
Condition: Hammer Toe; Surgery; Deformity of Toe; Phalanx; Dislocation Toe(S)
MeSH terms: Hammer Toe Syndrome; Congenital Abnormalities
Study type: Interventional

Summary: 
      Hammertoe deformity is one of the most common deformities in the foot and is characterized by
      dorsiflexion of the proximal phalanx at the metatarsal-phalangeal joint and a plantarflexion
      of the middle phalanx at the proximal interphalangeal joint. Surgical intervention for this
      type of deformity is indicated when the symptoms progress and conservative treatments are not
      enough, that is, when we are faced with a rigid painful deformity.Arthrodesis of the proximal
      interphalangeal joint temporarily fixed with a Kirschner wire is the most commonly used
      techniques.

      Therefore, intramedullary fixation with a PLLA needle may be a good alternative. The use of
      biomaterial is gaining relevance in foot surgery, with polylactic acid being the most widely
      used due to its strength. Its total biodegradation requires a time of 16-24 months. No cases
      of foreign body reaction have been described with this type of osteosynthesis material, due
      to its characteristics similar to those of bone. Its only drawbacks are that it increases the
      complexity of the technique and that it increases the cost of the procedure. Being a flexible
      needle, it allows to leave a functional intraoperative claw. It maintains the functionality
      of the distal interphalangeal joint and carries a lower risk of infection by carrying
      osteosynthesis material on the outside.

      The purpose of the present study is to prospectively collect clinical and radiographic
      outcomes of operative correction of hammertoe deformity using a fixation system of
      intramedullary device of polylactic acid versus a kirschner wire.
    

Detailed description: 
      A comparative, prospective, randomised study.
    

Intervention name(s): Arthrodesis interphalangeal with intramedullary resorbable fixation system
Intervention type(s): Procedure
Intervention description(s): Interphalangeal arthrodesis of lesser toes with two different fixation systems.
Other intervention name(s): Arthrodesis interphalangeal with kirschner wire fixation system
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: arthodesis; kirschner wire; PLLA