bioihbjkbjnl/mcl2 huggingface dataset:
Endocrine Studies of Healthy Children
Condition: Healthy
Study type: Observational

Summary: 
      Researchers would like to determine normal ranges for hormone levels and to learn more about
      the genetics involved in hormone production and action. Researchers will take samples of
      blood, urine, saliva, and stool from healthy children ages 5-17 in order to study different
      aspects of hormones.

      Establishing a range of normal hormone levels in children will make diagnosing illnesses with
      abnormal levels of hormones much easier. Hormone levels in the body can change throughout the
      day. By collecting samples at different times researchers hope to learn more about the normal
      daytime and nighttime patterns of hormone secretion. Because some hormone levels change with
      body size, researchers will also take measurements of patient's body composition.

      This study will involve children and observe them as inpatients or as outpatients. <TAB>
    

Detailed description: 
      We wish to obtain blood, urine, saliva, and stool specimens from healthy children ages 2-18
      years for use in establishing the normal ranges of levels of hormones and the variations in
      genes that are important for hormones to act. Such hormone values are extremely important to
      allow endocrinologists to determine when hormone levels are truly abnormal in children
      suspected of an illness. Because the values of some hormones change with body size, we will
      obtain measurements of body composition when studying such hormones. Children participating
      in this study may be studied in the outpatient clinic (at most 2 blood draws) or as
      inpatients on the pediatric ward (for frequent blood sampling using an intravenous line over
      a 24-hour period). Other studies that may be performed as part of this study include
      ultrasound examinations of the thyroid, adrenal, ovaries or testes, and x-ray of the hand and
      wrist for bone age determination.
    

Keywords: Development; Hormones; Growth; Metabolism; Eating Behavior; Body Composition; Normal Volunteer
Pharmacokinetics and Safety of GST-HG171 Tablets in Subjects With Impaired and Normal Liver Function
Condition: COVID-19 Pneumonia
MeSH terms: Pneumonia
Study type: Interventional
Phase: Phase 1

Summary: 
      This si a single-center, non-randomized, open, parallel, single-dose trial was designed to
      evaluate the safety and pharmacokinetic characteristics of GST-HG171 tablets in subjects with
      impaired liver function.
    


Intervention name(s): GST-HG171 Tablets
Intervention type(s): Drug
Intervention description(s): 150mg GST-HG171 Tablets
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PK/PD Biosimilarity Study of Gan & Lee Insulin Lispro Injection vs. EU and US Humalog® in Healthy Males
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary objective:

      To demonstrate pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of Gan & Lee Insulin
      Lispro Injection with both EU - approved Humalog® and US - licensed Humalog® (Reference
      Products) in healthy male subjects

      Secondary objectives:

      To compare the PK and PD parameters of the three insulin lispro preparations

      To evaluate the single dose safety and local tolerability of the three insulin lispro
      preparations
    


Intervention name(s): Gan & Lee Insulin Lispro Injection
Intervention type(s): Drug
Intervention description(s): All three IMPs will be administered as a 0.2 U/kg single dose subcutaneously in the periumbilical area by use of a disposable prefilled pen.
Other intervention name(s): EU - approved Humalog ®; US - licensed Humalog ®
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a phase 1 trial. The trial is a single center, randomized, doubleblind, single dose, there treatment, three period crossover, 12 - hour euglycaemic glucose clamp trial in healthy male subjects.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetes; Insulin; Lispro; Diabetes Mellitus; Basal; Bolus
Neural Correlates of Lidocaine Analgesia
Condition: Anesthesia; Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the effects of intravenous lidocaine on pain
      processing and cognitive function. Functional magnetic resonance imaging will be used to
      identify the neural correlates of these phenomena. The study will consist of 1 visit and
      involves no long-term follow up.
    

Detailed description: 
      This is an observational cohort study of volunteer subjects, which will employ neuroimaging
      and behavioral measures to characterize the effects of intravenous lidocaine on pain
      processing and cognitive function. A steady-state effect-site concentration of lidocaine will
      be achieved, and a short battery of cognitive behavioral tasks will be employed. At the dose
      target, pain task functional MRI and resting-state connectivity will be determined. This work
      will use a systems neuroscience approach to fill an important knowledge gap about the central
      effects of intravenous lidocaine, a commonly-used opioid alternative analgesic agent.

      Aim1: Determine cognitive behavioral effects of a steady-state dose of IV lidocaine using a
      short battery of tasks. The investigators hypothesize that the administration of lidocaine
      will correlate to decreased pain ratings, slowed psychomotor response, and decreased memory
      encoding.

      Aim2: Determine the neural effects of a steady-state dose of IV lidocaine in response to
      acute pain, and on resting connectivity. The investigators hypothesize that pain task-related
      activation will decrease in the insula and anterior cingulate, corresponding to decreased
      ratings of pain intensity and unpleasantness. Additionally, the investigators expect
      widespread decreases in long-range functional connectivity between brain areas know to be
      involved in these two areas and other known to be involved in pain processing.
    

Intervention name(s): Peripheral Nerve Stimulation; Lidocaine IV
Intervention type(s): Device; Drug
Intervention description(s): Experimental acute pain stimulus will be delivered using an electric nerve stimulator.; Subjects will receive an intravenous infusion of lidocaine for about 30 minutes.
Other intervention name(s): Electric Nerve Stimulation; Xylocaine
Intervention MeSH terms: Lidocaine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: lidocaine; functional MRI; electric nerve stimulation; functional connectivity
Cross-over Comparison of the V60 System to Other Bi-Level Noninvasive Ventilators
Condition: Respiratory Insufficiency; Respiratory Failure
MeSH terms: Respiratory Insufficiency
Study type: Interventional

Summary: 
      The purpose of this study is to compare a new noninvasive ventilator to existing ventilators
      already used for patient care.
    

Detailed description: 
      The primary objective of this study was to compare the performance (i.e., patient
      self-reported Comfort score) of the V60 device and a conventional noninvasive ventilator
      (patient's current ventilator). For the User Needs Assessment, the primary objective of the
      study was to validate the V60 to user needs. All patients were volunteers from the
      Respiratory Section of the Health Sciences Centre at the University of Manitoba. The study
      utilized a randomized 2-period cross-over study design to compare the V60 System to the
      patients' existing conventional noninvasive ventilator in different ventilation modes.
    

Intervention name(s): noninvasive ventilator
Intervention type(s): Device
Intervention description(s): Experimental V60 Mask noninvasive Ventilator for treating patients with COPD, then Comparator Conventional Mask noninvasive Ventilator for treating patients with COPD in crossover study design
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: noninvasive ventilation
Change of Range of Motion of TMJ After Correction of Pelvic a Symmetry in Women With Cyclic Pelvic Pain
Condition: Pelvic Pain
MeSH terms: Pelvic Pain
Study type: Observational

Summary: 
      Clinical experiences have shown that significant pain regression during a menstrual cycle has
      been often achieved by the use of spinal manipulative therapy (SMT) indicated in women with
      primary dysmenorrhea with coexisting functional disorders of lumbosacral (LS) spine. Namely,
      by activation of the nociceptive and vegetative system, LS spine disorders, before all
      segmental dysfunction and degenerative changes, can induce referred pain and reflex
      disturbances of pelvic organs (somatovisceral reflexes). Since significant improvement or
      disappearance of pain during a menstrual cycle is often achieved with adequate therapy of
      coexisting vertebral disorders in women with primary dysmenorrhea, it is important to
      recognise latent or manifest vertebral disorders in dysmenorrheic women using clinical
      examination (Grgić, 2009).
    


Intervention name(s): muscle energy technique
Intervention type(s): Other
Intervention description(s): Muscle energy technique:
Application of MET for bone of pelvis:
I) Pubis:
Cranial Os pubis.
Caudal os pubis.
II) ileum:
Anterior ileum.
Posterior ileum.
External Rotation (In flare) Lesion.
Internal Rotation (Out flare) Lesion.
III) sacrum:
Forward torsion of sacrum.
Backward torsion of sacrum.
Muscle energy technique for specific muscles of pelvis and spine:
Stretch of the Psoas Major.
Stretch of the paravertebral muscle.
Stretch of the piriforms.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        the participants will be divided randomly into two groups equal in numbers study group
        (group A) and control group (group B).

        • Study group (group A): It will consist of fifteen subjects who will receive osteopathic
        technique six treatment ( sessions) around three cycles two treatment every month first
        treatment after the end of menstruation.second treatment before the next cycle. In addition
        to their medical treatment if needed non-steroidal anti-inflammatory drugs (NIAIDS).

        • Control group (group B): It will consist of fifteen subjects who will reeive sham
        treatment,will take their medical treatment only non-steroidal anti- inflammatory drugs
        (NIAIDS) if needed.
A Study to Evaluate the Safety and Efficacy of Ruxolitinib Phosphate Cream Applied Topically to Adults With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to establish the efficacy of each strength of ruxolitinib cream
      once daily (QD) or twice daily (BID) in participants with atopic dermatitis as compared with
      vehicle cream BID.
    


Intervention name(s): Ruxolitinib 0.15% Cream QD; Ruxolitinib 0.5% Cream QD; Ruxolitinib 1.5% Cream QD; Ruxolitinib 1.5% Cream BID; Triamcinolone 0.1% Cream BID; Vehicle Cream BID
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Ruxolitinib 0.15% cream QD; Ruxolitinib 0.5% cream QD; Ruxolitinib 1.5% cream QD; Ruxolitinib 1.5% cream BID; Triamcinolone 0.1% cream BID; Vehicle cream BID
Other intervention name(s): INCB018424; INCB018424; INCB018424; INCB018424
Intervention MeSH terms: Triamcinolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Atopic dermatitis; eczema; pruritus; Janus kinase (JAK) inhibitors
Epidemiology of Barrett's Esophagus: A Population Based Study
Condition: Barrett's Esophagus; Gastroesophageal Reflux Disease (GERD); Olmsted County Resident
MeSH terms: Barrett Esophagus; Gastroesophageal Reflux
Study type: Observational

Summary: 
      To assess attitudes toward screening for esophageal adenocarcinoma (EAC) and Barrett's
      esophagus (BE) in the community.

      To develop a population based clinical risk factor prediction model for the diagnosis of BE
      and identify novel risk factors for BE which would make population based screening more
      efficient. This will be an important first step in identifying the target population for BE
      screening, another crucial component of making screening feasible and efficient
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Olmsted county resident
      
Biospecimen description: 
      Blood
    
Keywords: Barrett's esophagus; gastroesophageal reflux disease; GERD
Safety of and Immunogenicity to an H1N1 Influenza Vaccine in HIV-infected Adults
Condition: HIV Infection
MeSH terms: Influenza, Human; HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, open label, phase II trial to evaluate the safety and immunogenicity of
      two different schedules of vaccination against influenza A H1N1 in HIV-infected individuals,
      in which each of the randomized groups will be compared with HIV-negative volunteers
      vaccinated with the regimen indicated by the Brazilian National Immunization Program. Will be
      included in the study HIV-infected patients, stratified by CD4 count (< 200 cells/mm3 or >
      200 cells/mm3) at the time of screening for the study, not receiving antiretroviral therapy
      treatment or receiving stable treatment for at least 8 weeks, with no plans to change over
      the next 6 months, eligible to receive vaccine against influenza A H1N1. The control group
      will be formed by HIV-negative individuals, confirmed by serology performed at screening,
      eligible to receive vaccine against influenza A H1N1. Patients infected with HIV will receive
      one of two possible vaccination regimens: 1) 3.75 µg in two applications 21 days apart, 2)
      7.5 µg in two applications 21 days apart. The volunteers in the control group will receive a
      single application of 3.75 µg dose of the vaccine. The study's hypotheses are: 1) The vaccine
      against the H1N1 virus promotes antibody titers above the level specified for protection
      (seroconversion), being as safe and well tolerated in patients HIV-1 infected as in non
      HIV-infected volunteers; 2) The proportion of seroconversion for H1N1 virus vaccine at a dose
      of 3.75 µg in HIV-1-infected patients is similar to the proportion of seroconversion induced
      by the same vaccine at a dose of 7.5 µg; 3)The proportion of seroconversion with one dose of
      the vaccine against H1N1 virus is similar to the proportion after the second dose.
    


Intervention name(s): Adjuvanted vaccine against H1N1 influenza virus (GSK); Adjuvanted vaccine against H1N1 influenza virus (GSK); Adjuvanted vaccine against H1N1 influenza virus (GSK)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Patients infected with HIV will receive 3.75 µg of an adjuvanted A H1N1 vaccine in two applications 21 days apart.; Patients infected with HIV will receive 7.5 µg of an adjuvanted A H1N1 vaccine in two applications 21 days apart.; Control group will receive 3.75 µg of an adjuvanted A H1N1 vaccine in one single application.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV, influenza A H1N1, vaccine
Effects of Phenytoin on Cocaine Use in Humans - 2
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effects of phenytoin on the self-administration
      of smoked cocaine.
    

Detailed description: 
      The purpose of this study was to determine the effects of phenytoin on smoked cocaine-base
      self-administration using our laboratory self-administration model. A total of 12 patients
      randomized, 6 to phenytoin and 6 to placebo treatment group. There were 2 phases in this
      10-day inpatient study. Phase 1 subjects underwent one cocaine self-admin session.
      Randomization took place at the start of Phase 2, Day 4 where subjects received either
      placebo or phenytoin. The subjects assigned to phenytoin treatment received an oral loading
      dose (20mg/kg) aimed at achieving plasma phenytoin concentration of (10-20 mg/L). During
      Phase 2, subjects had the opportunity to self-administer cocaine on Days 5, 7, and 9. The
      plasma phenytoin levels were expected to decrease gradually during Phase 2 which provided an
      opportunity to study the effect of decreasing phenytoin plasma concentrations on cocaine
      self-administration.
    

Intervention name(s): Phenytoin
Intervention type(s): Drug
Intervention MeSH terms: Phenytoin
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: cocaine dependence
Study of the Safety & Efficacy of Intravenous Acetaminophen in Pediatric Inpatients
Condition: Pain; Fever
Study type: Interventional
Phase: Phase 3

Summary: 
      Intravenous acetaminophen (IVAPAP) is safe in repeated dose, multi-day clinical use when
      administered at a daily dose of 40 to 75 mg/kg body weight
    

Detailed description: 
      To assess the safety of intravenous acetaminophen (IV APAP) when used over one or more days
      for the treatment of acute pain or fever in pediatric (neonates, infants, children and
      adolescents) inpatients who are unable to take anything by mouth (NPO), require or would
      benefit from IV treatment, or are willing and able to stay on IVAPAP therapy for 1 to 7 days.
    

Intervention name(s): IV Acetaminophen
Intervention type(s): Drug
Intervention description(s): Target is 1 to 7 days of therapy with intravenous (IV) Acetaminophen (IV APAP) at a dose of 40 to 75 mg/kg body weight/day administered as an IV infusion (or by syringe pump) over 15 minutes and given every 4 to 6 hours as a scheduled dose
Other intervention name(s): IV APAP; APAP
Intervention MeSH terms: Acetaminophen
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy, Safety and Tolerability of Agomelatine Sublingual Tablets in the Treatment of Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will assess efficacy, safety and tolerability of 0.5 mg/day and 1 mg/day of
      sublingual (under the tongue) formulation of agomelatine in patients with Major Depressive
      Disorder. This study includes an 8-week double-blind phase.
    


Intervention name(s): Agomelatine (AGO178C); Agomelatine (AGO178C); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Agomelatine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Agomelatine; Major Depressive Disorder; MDD; depression
Comparison of Recovery Profiles Among Propofol, Remimazolam, and Dexmedetomidine After Intraoperative Sedation
Condition: Remimazolam; Propofol; Dexmedetomidine; Orthopedic Procedures; Sedatives; Brachial Plexus Block
Study type: Interventional
Phase: Phase 4

Summary: 
      A total of 120 patients (American Society of Anesthesiologist Physical Status 1-3) who signed
      a consent form among patients aged 19-80 years who are scheduled to undergo brachial plexus
      block and upper extremity surgery under monitored anesthetic care at our hospital were
      enrolled.

      Recruited patients are divided into three groups through computer-generated randomization by
      using the patient identification number assigned during patient recruitment. (40 people in
      each group) Standard monitoring is performed when the patient arrives at the operating room.
      Patients receive oxygen at 5-6 L/min using a simple facial mask, and receive a brachial
      plexus block under ultrasound guidance. After confirming the success of brachial plexus
      block, administration of propofol, remimazolam, or dexmedetomidine is started according to
      the assigned group. Assess the patient's level of consciousness through the MOAA/S (modified
      observer's assessment of alertness/sedation scale) scale. The drug injection ends when the
      skin suture is started after the main procedure. The time from the end of injection of each
      drug until MOAA/S becomes 5 points is measured. After the patient is transferred to the
      recovery room, the Aldrete score is assessed.

      The recovery profile, perioperative hemodynamic change, desaturation event, block duration,
      patient movement during surgery, patient satisfaction, and surgeon's satisfaction were
      investigated and analyzed for comparison.
    


Intervention name(s): Remimazolam; Propofol; Dexmedetomidine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The patient receives continuous infusion of remimazolam at a rate of 0.3-1.0 mg/kg/hr.; Patients are administered propofol at an effective site concentration of 1.0-2.5 mcg/ml through target-controlled infusion.; The patient is administered a dose of dexmedetomidine at 1 mcg/kg for 10 minutes, followed by continuous infusion at a rate of 0.2-1.0 mcg/kg/hr.
Intervention MeSH terms: Dexmedetomidine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment