bioihbjkbjnl/mcl2 huggingface dataset:
Effects of High Ventilation Breathwork With Retention (HVBR) on Health
Condition: Stress; Anxiety; Depressive Symptoms; Mental Wellbeing; Positive Affect; Negative Affect; Sleep-Related Impairment
MeSH terms: Depression
Study type: Interventional

Summary: 
      The investigators are conducting a randomised-controlled trial comparing high ventilation
      breathwork with retention (HVBR) to a breathwork placebo (paced breathing at 15breaths/min
      with brief retentions). The metric of 15b/min aligns with guidance from the British Journal
      of Nursing, Royal College of Physicians and Johns Hopkins Medicine which state that the
      average, healthy rate should range from: 12-20, 12-18 and 12-16b/min, respectively. The main
      questions the study attempts to address are: Does HVBR lead to improved state and trait
      mental health and wellbeing in a general population adult sample?

      The study will be conducted entirely online through the research platform Prolific, so
      participant data will be anonymous. The investigators will collect self-reports of mental
      health and wellbeing before and after the three-week breathwork period, in addition to a
      follow-up three weeks later. Pre-post intervention and follow-up questionnaires will be
      completed online via the survey platform Qualtrics which will be linked to Prolific. Data on
      self-reported adherence to, and credibility/expectancy of, the breathwork will also be
      collected, along with participants' experiences to gauge the safety and tolerability of the
      breathwork protocol.
    


Intervention name(s): High ventilation breathwork with retention (HVBR); Placebo HVBR
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Intervention; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
IL-2 in Refractory Autoimmune Encephalitis
Condition: Encephalitis
MeSH terms: Encephalitis; Autoimmune Diseases of the Nervous System
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether low-dose IL-2 is effective in refractory
      autoimmune encephalitis.
    

Detailed description: 
      Autoimmune encephalitis is a recently recognized etiology of encephalitis which is mediated
      by various autoantibodies targeting neural cells or synapses. The responses to immunotherapy
      is generally good, considerable proportion of patients with autoimmune encephalitis have
      unfavorable clinical outcomes. Recently, depletion of regulatory T cell (Treg cell) is
      reported in variable autoimmune diseases and multiple studies have shown that low-dose
      interleukin-2(IL-2) specifically activates Treg cells to control autoimmunity and
      inflammation.

      Protocol: This study is a single arm open-label study assessing clinical responses to the
      administration of low-dose IL-2 in autoimmune encephalitis patients who are refractory to
      first- and second-line immunotherapy.

      Objective: To assess the efficacy of low-dose IL-2 in autoimmune encephalitis, resistant to
      first- and second- line immunotherapy.

      Methods: This is a single arm open-label study. Each patients will receive four cycles of
      subcutaneous Proleukin (Interleukin-2, IL-2) (Week-1; 1.5 million IU (MIU)/d from Day-1 to
      Day-5, Week-3, -6, -9; 3MIU/d from Day-1 to Day-5) in the hospital. The patients will be
      followed up for 3 months (Week-21).

      Primary outcome - clinical efficacy by modified Rankin Scale Secondary outcome - Immunologic
      follow-up of Treg cells before, during, and after IL-2 therapy, quality of life, cognitive
      function, side effect of low-dose IL-2
    

Intervention name(s): Proleukin
Intervention type(s): Drug
Intervention MeSH terms: Aldesleukin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Early Childhood Follow-up of Congenital Diaphragmatic Hernia Survivors
Condition: Hernia, Diaphragmatic
MeSH terms: Hernias, Diaphragmatic, Congenital; Hernia; Hernia, Diaphragmatic
Study type: Observational

Summary: 
      The primary objective of this study is to determine the medical and neurodevelopmental
      outcomes of congenital diaphragmatic hernia (CDH) survivors at school-age (4-6 years)
      follow-up. It is generally assumed that older CDH survivors have normal daily function and
      are able to live normal lives, but this has not been adequately studied.
    

Detailed description: 
      Congenital diaphragmatic hernia (CDH) is a relatively rare malformation, seen in
      approximately 1 in 3000-5000 live births. The overall survival for infants born with CDH
      ranges from 50-70% despite continuing advances in prenatal diagnosis and post-natal medical
      and surgical care. Infants with CDH remain one of the most complex groups of patients to care
      for - both in the intensive care nursery and after hospital discharge.

      Several studies have shown that CDH survivors have predictable pulmonary, gastrointestinal,
      cardiac, and neurologic morbidities. In particular, CDH survivors are at an increased risk
      for growth and nutrition difficulties, including feeding problems, symptomatic
      gastroesophageal reflux, and failure to thrive. They are also more likely to suffer from
      chronic lung disease, bronchial hyperreactivity, and pulmonary hypertension. In addition, a
      significant number of CDH survivors show evidence of neurocognitive delay, hearing
      impairment, and behavioral disorders in follow-up studies.

      Most outcome studies of CDH survivors have focused on the 18-36 month follow-up period.
      However, there is a paucity of literature on longer-term, school-age outcomes of these
      children. In order that we might better understand the impact of our current CDH management
      protocols, it is imperative to determine whether the cognitive delays and other morbidities
      noted in these patients at an early age are of a transient nature, or persist throughout
      childhood. It is also crucial to develop a predictive model to understand which patients with
      CDH will undoubtedly develop long-term neurodevelopmental impairment. Collecting and sharing
      knowledge with the broader community of Neonatal Intensive Care providers who manage infants
      with CDH will ultimately help guide therapeutic strategies in the intensive care nursery so
      that parents can make informed decisions about aggressiveness of care and we may optimize the
      outcomes of this unique patient population.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All infants with Congenital Diaphragmatic Hernia (CDH) born between 2001 and 2005 who were
        managed at Duke University Medical Center will be eligible for inclusion in the study.
      
Keywords: Hernia, Diaphragmatic; Asthma; Feeding and Eating Disorders of Childhood; Growth & Development
Randomized Study of the Efficacy and Safety of a Single Dose of Synvisc-One® in Chinese Patients With Symptomatic Osteoarthritis of the Knee
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective:

      -To evaluate the efficacy of a single 6-milliliter (mL) intra-articular (IA) injection of
      Hylan G-F 20 measured by Western Ontario and McMaster Universities Osteoarthritis Index
      (WOMAC) Numerical Rating Scale (NRS) 3.1 A1 score, in comparison to an IA placebo injection
      over 26 weeks, in Chinese participants with symptomatic Osteoarthritis (OA) of the knee.

      Secondary Objectives:

        -  To evaluate the efficacy of a single 6-mL IA injection of Hylan G-F 20 measured by 7-day
           average score of WOMAC A1 pain sub-score in comparison to an IA placebo injection over
           26 weeks.

        -  To evaluate the efficacy of a single 6-mL IA injection of Hylan G-F 20 measured by WOMAC
           A, patient global assessment (PTGA) and clinical observer global assessment (COGA) in
           comparison to an IA placebo injection over 26 weeks.

        -  To evaluate the response rate of a single 6-mL IA injection of Hylan G-F 20 in
           comparison to an IA placebo injection over 26 weeks. Response was defined as WOMAC A1
           greater than or equal to (>=) 2-point improvement from baseline on NRS.

        -  To evaluate the safety of a single 6-mL IA injection of Hylan G-F 20, in comparison to
           an IA placebo injection over 26 weeks.
    

Detailed description: 
      The duration of the study was 29 weeks at maximum. The screening and wash-out period lasted
      for up to 14 days, depending on the half-life of the medications followed by an 8-day
      baseline period including the treatment day. Overall, there were up to 21 days between
      signing informed consent (at screening visit) and the randomization (Day 1). Treatment was
      administered on Day 1, and follow-up period was 26 weeks.
    

Intervention name(s): Hylan G-F 20 (GZ402662/SAR402662); Placebo
Intervention type(s): Device; Drug
Intervention description(s): Pharmaceutical form: Solution for injection
Route of administration: Intra articular; Pharmaceutical form: Solution for injection
Route of administration: Intra articular
Other intervention name(s): Synvisc-One
Intervention MeSH terms: Hylan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study In Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluates the effect of medicines for type 2 diabetes and lipids control. This
      study will require about 6 office visits for lab tests and examinations. All study related
      medicines and medical examinations will be provided at no cost to the subjects.
    


Intervention name(s): GSK523338
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: Type 2 diabetes Type II
Repetitive Transcranial Magnetic Stimulation (rTMS) in Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      This study aims to evaluate the effectiveness of 10 Hz neuronavigated repetitive transcranial
      magnetic stimulation (rTMS) to the left dorsolateral prefrontal cortex (DLPFC) on pain,
      stiffness, fatigue, depression/anxiety, quality of life and cognitive functions in
      fibromyalgia syndrome (FMS).
    

Detailed description: 
      This is a single-center, prospective, randomized, double-blind, sham-controlled study in
      two-arm parallel-group design. Twenty participants will be randomized into 2 groups.
      Randomization will be performed using computer-generated block randomization with 1:1
      allocation between the active rTMS group (Group 1) and the sham-control group (Group 2).
      Group 1 will receive high frequency repetitive transcranial magnetic stimulation
      (10hz-HF-rTMS)-A total 14 sessions of HF-rTMS, 10 sessions daily (5 days/week, 2 weeks) and 4
      sessions weekly (1 day/week, 4 weeks). Group 2 will receive sham stimulation-A total 14
      sessions of sham-rTMS, 10 sessions daily (5 days/week, 2 weeks) and 4 sessions weekly (1
      day/week, 4 weeks).All patients will be evaluated with pain severity (VAS-10mm),stiffness
      severity (VAS-10mm), Fibromyalgia Impact Questionnaire (FIQ), Fatigue Severity Scale (FSS),
      Hospital Depression Anxiety Scale (HADS), Addenbrook Cognitive Examination-revised version
      (ACE-R).Patients will be questioned for the safety of treatment. Available drug therapies
      will be continued in both groups. Patients and clinical raters will be blinded to treatment.
      All patients will be reviewed by the investigator in terms of rTMS treatment safety and motor
      threshold determination before each treatment session and observed for possible side effects
      after treatment. All side effects will be recorded. Magnetic stimulation will be applied
      using Neurosoft-Neuro MS/D with a figure-of-eight-shaped coil. rTMS therapy will be applied
      under the guide of neuronavigation with the following parameters: target-left DLPFC, with the
      %90 of the RMT, 10 Hz stimulation for 5 seconds intervals (on) with 25 seconds inter-train
      intervals (off), 15 minutes, 1500 pulses.
    

Intervention name(s): rTMS + Neuronavigation
Intervention type(s): Device
Intervention description(s): Repetitive Transcranial Magnetic Stimulation (Neuro-MS/D) + Neural Navigator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Fibromyalgia, neuronavigated-rTMS, pain, stiffness, fatigue
Cervical Cord to Canal Diameter Ratio
Condition: Cervical Pain
MeSH terms: Neck Pain
Study type: Observational

Summary: 
      Cervical epidural block could cause spinal cord injury if the epidural needle is
      over-inserted and punctures the spinal cord. Investigators retrospectively evaluated the
      imaging data of 100 patients (50 men and 50 women) who underwent both cervical computed
      tomography (CT) and cervical magnetic resonance imaging (MRI) at our hospital. Investigators
      measured the diameters of the spinal canal and spinal cord from the 3rd cervical vertebra to
      the 1st thoracic vertebra (T1) at each level by using the patients' cervical CT and MR
      images. The spinal cord and spinal canal diameters were measured in the transverse plane of
      cervical MR and CT images, respectively.
    

Detailed description: 
      The spinal canal diameter, i.e., the epidural transverse diameter, was measured as the
      distance between the innermost border of the left and right pedicles at each upper pedicular
      level from C3 to T1 on transverse CT images by using a picture archiving and communication
      system (PACS; INFINITT PACS G3, INFINITT Healthcare, Korea) The spinal cord diameter was
      measured between the left and right outermost distances of the cord at each upper pedicular
      level, which were almost the same locations used for measuring the spinal canal diameter,
      from C3 to T1 on transverse MR images by using the PACS.
    

Intervention name(s): computed tomography, Magnetic resonance image
Intervention type(s): Radiation
Intervention description(s): Investigators measured the cervical cord and canal diameter by using CT and MRI that were previously taken.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        patients who visited Daegu catholic university hospital
      
Keywords: Coronal; Cervical canal diameter; Cervical cord diameter
Inadvertent Hypothermia or Hyperthermia in Pediatric Radiotherapy Practices Under Anesthesia
Condition: Hypothermia; Anesthesia; Hyperthermia, Anesthesia Related; Radiotherapy Side Effect; Childhood Cancer
MeSH terms: Hypothermia; Hyperthermia; Fever; Malignant Hyperthermia
Study type: Observational

Summary: 
      In prospective, observational cohort study, changes in body temperature will be investigated
      before the procedure and during recovery in Radiotherapy patients aged 0-18 years who need
      sedation due to childhood malignancies.

      The aims of this study were to measure the incidence and magnitude of changes in body
      temperature in children undergoing sedation or general anesthesia for Radiotherapy, and to
      determine their effects on the recovery process.
    


Intervention name(s): radiotherapy under anesthesia
Intervention type(s): Procedure
Intervention description(s): Body temperature change will be investigated before the procedure and during recovery in Radiotherapy patients who need anesthesia due to childhood malignancies.
Intervention MeSH terms: Anesthetics
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients undergoing radiotherapy under anesthesia
      
Keywords: Hypothermia; Anesthesia; Hyperthermia, Anesthesia Related; Radiotherapy Side Effect; Childhood Cancer
Flupenthixol Treatment in Schizophrenic Cocaine Abusers - 1
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of flupenthixol for cocaine
      dependence in individuals with schizophrenia/schizoaffective illness.
    


Intervention name(s): Flupenthixol
Intervention type(s): Drug
Intervention MeSH terms: Flupenthixol; Flupenthixol decanoate
Primary purpose: Treatment
Keywords: cocaine dependence
Adolescent Mental Health: Canadian Psychiatric Risk and Outcome Study
Condition: Psychotic Disorders; Depressive Disorder, Major; Bipolar Disorder
MeSH terms: Depressive Disorder; Bipolar Disorder; Mental Disorders; Psychotic Disorders; Depressive Disorder, Major
Study type: Observational

Summary: 
      The primary study aims are to determine the clinical, behavioural and social predictors of
      SMI development in youth, and to investigate whether neuroimaging can distinguish youth who
      will develop SMI from those who will not.

      The study's secondary aims are to examine the proportions of the cohort that make transitions
      between the different clinical stages of risk, and to determine the proportions that have
      poor outcomes, defined as ongoing or increased symptoms, secondary substance misuse, poor
      social or role functioning, i.e., non-participation in education, or employment, and new
      self-harm.

      Investigators will study a cohort of 240 youth (aged 14-25, male and female) that includes
      youth with early mood symptoms or sub-threshold psychotic symptoms (symptomatic group;
      n=160), youth at risk due to a family history of a SMI (family high risk (FHR); n=40), and
      healthy controls (HC; n=40). From this cohort, clinical, social and cognitive data, as well
      as imaging data will be gathered to create a multi-layered "snapshot" of these individuals
      and provide full-level characterization. Investigators will use the full range of clinical
      and imaging data generated from this cohort to develop novel prediction algorithms
      incorporating key variables that predict the development of SMI.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Young people aged 12-25 who report 1 of the following:

          1. early mood symptoms or sub-threshold psychotic symptoms (n=160);

          2. a family history of a SMI (n=80); or

          3. are healthy with no mental health concerns (n=40).
      
Biospecimen description: 
      Blood samples
    
Keywords: Attenuated Psychotic Symptoms
Neuropsychological Functioning in Children With Attention-Deficit/Hyperactivity Disorder.
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the change in neuropsychological status from
      baseline to 6 months post-initiation of atomoxetine treatment in children ages 6 to 10.5
      diagnosed with ADHD.
    


Intervention name(s): Atomoxetine Hydrochloride
Intervention type(s): Drug
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Therapeutic Efficacy of the VRC01 Antibody in Patients Who Initiated Antiretroviral Therapy During Early Acute HIV Infection
Condition: HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will evaluate the safety and therapeutic efficacy of the human monoclonal antibody
      (mAb) VRC-HIVMAB060-00-AB (VRC01), when administered during analytic treatment interruption
      (ATI), in adults who began antiretroviral therapy (ART) during early acute HIV infection.
    

Detailed description: 
      Human monoclonal antibodies (mAbs) may have the potential to treat HIV infection by
      preventing the spread of the virus. This study will evaluate an experimental mAb known as
      VRC-HIVMAB060-00-AB (VRC01). The purpose of this study is to evaluate the safety and
      therapeutic efficacy of VRC01, when administered during analytic treatment interruption
      (ATI), in adults who began antiretroviral therapy (ART) during early acute HIV infection.

      The study will enroll participants from the RV 254 study who were diagnosed during early
      acute HIV infection and who have been on ART. At study entry, participants will stop taking
      their antiretroviral (ARV) medications. They will be randomly assigned to receive an
      intravenous (IV) infusion of VRC01 or placebo at Weeks 0 (study entry), 3, 6, 9, 12, 15, 18,
      21, and 24. For 7 days following each infusion, participants will be asked to record and
      report any symptoms to study researchers.

      In addition to the infusion visits, participants will attend follow-up visits for 48 weeks.
      Study visits may include physical examinations, blood collection, and urine collection.
      Neurocognitive testing will take place at select study visits. Some participants may take
      part in optional study procedures including mucosal secretion collection, MRI brain scan,
      colon biopsy, lymph node biopsy, leukapheresis, and lumbar puncture.

      Study staff will monitor participants' HIV throughout the study, and participants will end
      their participation in the study and restart their ARV medications, if needed.
    

Intervention name(s): VRC01; Placebo for VRC01
Intervention type(s): Biological; Biological
Intervention description(s): 40 mg/kg; administered IV; Sodium Chloride for Injection 0.9%, USP; administered IV
Other intervention name(s): VRC-HIVMAB060-00-AB
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Human Monoclonal Antibody