bioihbjkbjnl/mcl2 huggingface dataset:
A Comparative Safety and Pharmacokinetic Study of JHL1922 and Pulmozyme® in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a double-blind, randomised, 2 single-doses and then repeated-dose (5 days), 2-arm,
      2-period crossover phase 1 study in 24 healthy male or female subjects. Subjects will be
      randomised to one of two treatment sequences in 2 treatment periods: JHL1922 (test treatment)
      first and then Pulmozyme (reference treatment) or Pulmozyme (reference treatment) first and
      then JHL1922 (test treatment).
    

Detailed description: 
      All 24 subjects will receive either JHL1922 or Pulmozyme as single doses of 2.5 mg and then
      10 mg per eRapid nebulizer, followed after a washout by a 5-period of daily dosing of 10 mg
      of either JHL1922 or Pulmozyme per eRapid nebulizer.

      The primary objective is to assess the similarity of safety and tolerability of test
      products, and the exploratory objective is to assess the similarity, if possible, of the
      systemic levels and sputum levels of dornase alfa after administration of test products.
    

Intervention name(s): JHL1922; dornase alfa
Intervention type(s): Biological; Biological
Intervention description(s): Single doses of JHL1922 2.5 mg and then 10 mg per eRapid nebulizer; Single doses of Pulmozyme® 2.5 mg and then 10 mg per eRapid nebulizer
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pharmacogenetic Response to Chemotherapy Induction for ORL Cancers
Condition: Carcinoma, Squamous Cell; Mouth Neoplasms; Oropharyngeal Neoplasms; Laryngeal Neoplasms; Hypopharyngeal Neoplasms
MeSH terms: Neoplasms; Carcinoma, Squamous Cell; Laryngeal Neoplasms; Oropharyngeal Neoplasms; Mouth Neoplasms; Hypopharyngeal Neoplasms
Study type: Observational

Summary: 
      The purpose of this study is to determine if there is a correlation between tumor response
      after 3 doses of chemotherapy by induction using Docetaxel, Cisplatine and 5-Fluorouracile
      for advanced stage epidermoid carcinomas of the upper aero digestive tract and the presence
      of one or a combination of 3 genetic polymorphisms and/or 5 intra-tumoral transcriptional
      modifications.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The patients included in this study have been diagnosed with an advanced stage squamous
        cell carcinoma in the buccal, oropharyngeal, laryngeal or hypopharyngeal areas.
      
Biospecimen description: 
      Surplus blood, tumor tissue from biopsies, and DNA will be stocked in the Biothèque of the
      Nîmes University Hospital
Evaluation of Mechanical Characteristics of Tendons of Athletes Using Sonography
Condition: Overuse Injury; Rotator Cuff Injuries
MeSH terms: Wounds and Injuries; Rotator Cuff Injuries; Cumulative Trauma Disorders
Study type: Observational

Summary: 
      The investigators analyzed the strain of the rotator cuff tendon of baseball pitchers
      obtained using ultrasonography and compared the change in peak tendon strain before and after
      the regular season.
    


Intervention name(s): Ultrasonography
Intervention type(s): Diagnostic Test
Intervention description(s): Collect shoulder rotator cuff tendon ultrasound image during isotonic motion
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Baseball pitcher from city baseball team and actively participating season games
Safety and Efficacy Assessment of Diagnostic Microprobe (inPROBE) in Women at High Risk of Breast Cancer (Part I Study)
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to preliminarily determine the correlation of HER2 receptor
      levels detected with the inPROBE diagnostic probe relative to receptor status as determined
      by standard methods (IHC/FISH), in women with both HER2-positive and HER2-negative breast
      cancer.
    


Intervention name(s): Diagnostic microprobe (inPROBE) medical device
Intervention type(s): Device
Intervention description(s): Introduction of the inPROBE microprobe (two simultaneous punctures) into the breast as a procedure prior to surgical resection of tumors with known HER2 receptor status.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Study of Safety and Effectiveness of PoNS Device to Treat Chronic Balance Deficit Due to Traumatic Brain Injury (TBI)
Condition: Traumatic Brain Injury; Chronic Balance Disorder
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional

Summary: 
      The purpose of this study is to determine if clinic and home training with a study device
      will improve a balance deficit. The study device is called Portable Neuromodulation
      Stimulator (PoNS). The study device will be placed on the tongue to deliver nerve
      stimulation. The study is testing if use of the study device in conjunction with physical
      therapy will improve balance and gait in patients suffering from a TBI. The effects of using
      the device and undergoing therapy will be measured using standardized tests of movement
      control, gait, headache and other TBI symptoms.
    


Intervention name(s): Cranial nerve non-invasive neuromodulation via PoNS device; Sham PoNS device
Intervention type(s): Device; Device
Intervention description(s): The PoNS is a medical device worn around the neck. The controller contains the pulse generator and a user interface. The mouthpiece, held to the top of the tongue, contains 143 circular gold electrodes that deliver a mild, controlled electric stimulation to the subject. While the subject is receiving stimulation, they will perform increasingly difficult balance, posture, gait, and movement control tasks designed to challenge existing abilities. Each training session takes approximately one hour to complete, and is separated by an interval of 2-2.5 hours.; The PoNS is a medical device worn around the neck. The controller contains the pulse generator and a user interface. The mouthpiece, held to the top of the tongue, contains 143 circular gold electrodes that deliver a mild, controlled electric stimulation to the subject. The sham control device is physically identical but uses a modified stimulus waveform parameter set designed to elicit a mild tactile sensation while minimizing the net energy delivered, minimizing any neuromodulatory effect. While the subject is receiving stimulation, they will perform increasingly difficult balance, posture, gait, and movement control tasks designed to challenge existing abilities. Each training session takes approximately one hour to complete, and is separated by an interval of 2-2.5 hours.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Traumatic Brain Injury; Neuromodulation; Chronic Balance Disorder
Perineuraxial Anesthesia Fluid Management and Infant Neurobehaviors
Condition: Cesarean Section
Study type: Interventional

Summary: 
      Early change in neurobehavior is strongly associated with the intelligence development of
      children. Previous studies reported that cesarean section itself could influence the later
      development of children. In addition, neuraxial anesthesia including epidural, spinal and
      combined spinal epidural anesthesia (CSEA) are the major forms used during cesarean delivery,
      and these anesthesia techniques will undoubtedly evoke hypotension and corresponding
      hemodynamic alteration, of which would result in decreasing in umbilical placental
      insufficiency and fetus hypoxia leading to early abnormality of neurobehaviors in infants.
      Fluid management, such as crystalloid and colloid, is the common ones given before or / and
      after neuraxial anesthesia to prevent or reverse hypotension. However, it is still unknown
      whether the perineuraxial anesthesia fluid resuscitation could improve the neurobehavior
      scorings, and could produce positive effect on later intelligence development. Herein the
      investigators hypothesized that effective perineuraxial anesthesia fluid management during
      cesarean section would prevent the occurrence of hypotension and improve infant's
      neurobehavior scorings.
    


Intervention name(s): Ringer's Lactate; Six percent hydroxyethyl starch
Intervention type(s): Drug; Drug
Intervention description(s): Ringer's Lactate 8 ml/kg was given intravenously before or after epidural, spinal or CSEA in cesarean section; Hydroxyethyl starch (6%) was given before or after epidural, spinal or CSEA in cesarean section
Other intervention name(s): Lactated Ringer's solution; HES/HAES
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neurobehavior; Development; Fluid management; Neuraxial anesthesia
Effect of Prenatal Education on Perceptions of Epidural Acceptance
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      The purpose of the study is to determine if targeted prenatal educational program on womens'
      perceptions of epidural increases the acceptance of intrapartum epidural analgesia relative
      to the control group.
    

Detailed description: 
      Racial/ethnic disparities exist in the proportion of patients receiving epidural analgesia.
      The purpose of our study is to determine if culturally-sensitive educational program
      targeting womens' perceptions of epidural increases the acceptance of intrapartum epidural
      use.
    

Intervention name(s): Prenatal education
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: intrapartum pain management, epidural
Cuff(SZ): The Cuff Size Blood Pressure Measurement Trial
Condition: Hypertension; Blood Pressure; Cardiovascular Diseases; Cardiovascular Risk Factor
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      To determine the impact of overcuffing (using a too-large cuff) and undercuffing (using a
      too-small cuff) on initial BP and average BP measurements when using an automated BP device,
      overall and stratified by appropriate cuff size

      To determine if the impact over- or under-cuffing differs based on the following patient
      characteristics:

        1. Hypertensive (≥140/90 based on triplicate measures using appropriately sized cuff) vs.
           non-hypertensive.

        2. Arm circumference (continuous)

        3. Obesity status
    

Detailed description: 
      The investigators propose a cross-sectional study of adult participants recruited from the
      community. Enrolled participants will have 2-3 sets of three automated BPs measured, each set
      with a different cuff size. To accomplish this, the investigators will utilize a 2-3 period
      cross-over design:

      • Two or three different periods with 3 automated BP measurements, using a BP cuff that is:

        -  Appropriately sized based on mid-upper arm circumference ( standard)

        -  Too small (one size lower than appropriate)

        -  Too large (one size higher than appropriate)

      Individuals in whom the smallest available cuff (small adult) and largest available cuff
      (extra-large cuff) is appropriate for their arm circumference will only be able to undergo
      two periods of BP measurements.
    

Intervention name(s): Order of cuff sizes during blood pressure measurements
Intervention type(s): Other
Intervention description(s): Each participant will have 4 sets of 3 blood pressure measurements taken. The participants will be randomized to the order in which the cuff sizes are used.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Screening
Pharmacokinetics and Pharmacodynamics of ACP-001 (TransCon PEG hGH)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Double-blind, randomized, placebo and active controlled dose-ascending study to investigate
      safety, tolerability, pharmacokinetics and pharmacodynamics of ACP-001 (TransCon PEG hGH).
    


Intervention name(s): ACP-001 (TransCon PEG hGH); ACP-001 (TransCon PEG hGH); ACP-001 (TransCon PEG hGH); ACP-001 (TransCon PEG hGH); Placebo; Human Growth Hormone
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): ACP-001, dose-level 1, s.c., single-dose; ACP-001, dose-level 2, s.c., single-dose; ACP-001, dose-level 3, s.c., single-dose; ACP-001, dose-level 4, s.c., single-dose; Placebo, s.c., single-dose; Human Growth Hormone, s.c., daily for 7 days
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Psilocybin for Treatment-Resistant Depression
Condition: Treatment Resistant Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to see if psilocybin, an investigational drug, is safe and well
      tolerated. Researchers also want to know if psilocybin can improve symptoms of depression.
      This study will see if psilocybin is safe and well tolerated by tracking changes in suicidal
      thoughts and behaviour, monitoring if any participants choose to stop participating in the
      study, and measuring any serious side effects, as well as how long they take to resolve. This
      study will also see if depression symptoms improve (or worsen) after psilocybin is
      administered. Additional information about participants' depressive symptoms and side effects
      will also be measured during the study.
    

Detailed description: 
      This randomized clinical trial will assess the feasibility, safety, and efficacy of single
      and repeat doses of psilocybin at point-of-care in persons with treatment-resistant
      depression as part of major depressive disorder or bipolar II disorder. The primary objective
      is to evaluate the feasibility of psilocybin in adults with treatment-resistant depression.
      The secondary objectives are to assess the efficacy and tolerability of psilocybin at
      point-of-care.
    

Intervention name(s): Psilocybin
Intervention type(s): Drug
Intervention description(s): Participants will receive a single dose of psilocybin and be assessed weekly for six weeks and biweekly for 18 weeks. Participants who relapse may receive up to two repeated doses of psilocybin.
Intervention MeSH terms: Psilocybin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bipolar II Disorder; Major Depressive Disorder; Depressive Disorder, Treatment-Resistant; Mood Disorders; Mental Disorders; Psilocybin; Hallucinogen; Psychedelic; Antidepressant; Phase 2; Depression
The Effects of Puberty and Weight on Sugar Metabolism in Children
Condition: Overweight; Leanness; Adolescent
MeSH terms: Overweight
Study type: Observational

Summary: 
      Our goal is to investigate how hormones that control blood sugar, hunger, and stomach
      emptying change with puberty and being overweight. These substances change with a meal.

        -  For this, we need to compare lean and overweight children.

        -  We need to study them before and during puberty.

        -  All children in the study will be tested before and after a liquid meal.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Prepubertal and pubertal subjects.
      
Biospecimen description: 
      plasma
    
Keywords: Obese, Lean, Pubertal, Prepubertal, Glucose, Adolescents, Type 2 Diabetes
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PLX5622 in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to study the safety and tolerability of a single dose of PLX5622
      in healthy, adult human volunteers. This will be the first time PLX5622 has been taken by
      humans.
    


Intervention name(s): PLX5622; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): PLX5622 drug substance is an achiral,small molecule Fms kinase inhibitor. The drug product is available in capsule form, to be taken orally, in dosage strengths of 25 mg and 100 mg with matching placebo; Matching placebo for PLX5622.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Safety; Tolerability; Pharmacokinetics; PLX5622
Granulocyte-colony Stimulating Factor for Stem Cells Therapy for Acute Ischemic Stroke
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to investigate treatment with Leukostim (Filgrastim;
      granulocyte-colony stimulating factor; G-CSF) for acute ischemic stroke.
    

Detailed description: 
      Stroke is one of the main reasons of mortality and morbidity all over the world. In
      economically developed countries stroke takes 2 or 3 place in the structure of morbidity and
      mortality. In animal models, it was shown that autological stem cells transplantation
      significantly increased perfusion of ischemic area and improved lost motor and sensor
      functions. Granulocyte-colony stimulating factor (G-CSF) was used in some clinical trials
      without following autological transplantation. However, there are no enough evidence-based
      proved results of G-GSF safety and effectiveness in acute ischemic stroke. In order to
      determine safety and efficiency of G-CSF administration together with conventional treatment
      and conventional intensive care protocol during acute ischemic stroke we organized this
      clinical trial.
    

Intervention name(s): Filgrastim
Intervention type(s): Drug
Intervention description(s): 10 µg/kg subcutaneously once daily x 5 days
Other intervention name(s): Leukostim
Intervention MeSH terms: Lenograstim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ischemic stroke; Stem cells; Colony-stimulating factors; Filgrastim; Randomized controlled trial
Effects of Pravastatin on Cholesterol, Inflammation and Cognition in Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorders; Schizophreniform Disorders
MeSH terms: Inflammation; Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This study involves people with schizophrenia or schizoaffective disorder, who are currently
      taking antipsychotic medications. Some antipsychotic medications may cause an increase in
      cholesterol levels, which may lead to inflammation in the body. Inflammation poses a risk in
      developing heart disease, diabetes and problems with brain function. The purpose of this
      study is to see if pravastatin can:

        -  Lower cholesterol

        -  Decrease inflammation

        -  Improve cognition in patients with schizophrenia
    

Detailed description: 
      This study is a 12-week randomized, double-blind, placebo-controlled pilot study of
      pravastatin 40mg a day, administered for 12 consecutive weeks to subjects with schizophrenia
      to examine pravastatin's effects on lowering cholesterol levels and inflammatory markers, and
      improving cognition. The study will be conducted at the Freedom Trail Clinic and will use the
      Massachusetts General Hospital Clinical Research Center. The innovative approach of using
      pravastatin to not only decrease cholesterol levels, but to decrease inflammation and improve
      cognition in patients with schizophrenia is promising and may lead to a different approach to
      treatment in this population.
    

Intervention name(s): Pravastatin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks; pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
Other intervention name(s): pravastatin sodium; Pravachol
Intervention MeSH terms: Pravastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia; pravastatin; inflammation; cognition; antipsychotics; cholesterol
Evaluation of Speech-in-noise Performance in Cochlear Implant Recipients With a CROS Device on the Contralateral Ear
Condition: Hearing Loss, Sensorineural
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Sensorineural
Study type: Interventional

Summary: 
      Speech understanding in noise remains the greatest challenge for people using cochlear
      implants, particularly when the speech of interest comes from the side of the head opposite
      to the implant. Recent findings in hearing technology allow for people to either use a
      hearing aid or a Contralateral Routing of Signal (CROS) device on the non-implanted ear.
      Differences in speech understanding may result depending on the device chosen by a person,
      and these differences may be measureable through speech discrimination measurement methods.

      This study intends to determine whether or not a CROS device improves speech perception in
      noise when the source of the speech of interest originates from the side of the head opposite
      to the implant.
    


Intervention name(s): CROS; Hearing Aid; Cochlear Implant Alone
Intervention type(s): Device; Device; Other
Intervention description(s): Advanced Bionics CROS; Advanced Bionics Naida hearing aid; No hearing device on contralateral ear
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will be randomized into a group where they wear one of the processors and the order of conditions will be assessed, then they will switch to wear the other processor and the order of conditions will be assessed.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cochlear Implant; Hearing Loss; Hearing Aids; Hearing Tests
Non-Invasive Reduction of Fat in the Flanks of Patients With Sharp Body Curvature
Condition: Body Fat Disorder
MeSH terms: Lipid Metabolism Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of the ZELTIQ System and the
      CoolCurve+ applicator for non-invasive fat reduction in flanks for a patient population with
      sharp body curvature.
    

Detailed description: 
      The Zeltiq System with the CoolCurve+ applicator will be evaluated for safety and
      effectiveness in subjects with subcutaneous fat on the flanks and who have sharp body
      curvatures. The curvature of interest is typical of individuals who are relatively thin with
      a small body frame.
    

Intervention name(s): The Zeltiq System
Intervention type(s): Device
Intervention description(s): Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Other intervention name(s): Cryolipolysis; Lipolysis
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Lipolysis; Cryolipolysis; Fat Reduction