bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Comorbid Psychiatric Conditions on Results of Transforaminal Epidural Steroid Injection
Condition: Low Back Pain; Radiculopathy
MeSH terms: Radiculopathy; Low Back Pain
Study type: Interventional

Summary: 
      Low back pain (LBP) and radiculopathic pain are a major socio-economic problem affecting all
      age groups. 70% of people consult a doctor at least once in their life due to LBP. Radicular
      pain is thought to be caused by inflammation of the spinal nerve roots near the
      intervertebral disc injury. In this context, fluoroscopic guided transforaminal epidural
      steroid injection (TFESI) has been increasingly preferred in patients who can not benefit
      from conservative approach in the treatment of lumbosacral radiculopathic pain due to lumbar
      disc herniation in recent years.

      The assessment of comorbid psychiatric conditions such as depression, anxiety, and
      somatization disorder and given the detailed and visual information to patients who will be
      undergone TFESI could affect the result of the treatment in a good way. The pain
      questionnaire used for objectively evaluating injection outcomes is personality dependent and
      there are many factors that can affect it.
    

Detailed description: 
      Although information leaflets given to patients prior to surgical or non-surgical
      interventions have not yet been used as a standard in each clinic, the effects on patients
      have been frequently researched in recently. A detailed description of the treatment, the
      devices to be used and the disclosure of the steps of the procedure may have an effect on the
      result of the treatment. The aim of the study; (1) the presence of comorbid psychiatric
      conditions in patients with lumbar disc hernia and radiculopathy, (2) to evaluate the effect
      of the written and visual informative form given before the injection of the lumbosacral
      TFESI.
    

Intervention name(s): Information leaflet
Intervention type(s): Other
Intervention description(s): The written and visual information form prepared specifically for the patients was aimed to provide detailed information by clearly expressing the procedure, the suggestions that will be needed before and after injection (what to bring next, what circumstances may not be done, the control visit day after the procedure etc.) to be applied on before the injection day.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel group
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Transforaminal epidural steroid injection; Radicular pain
Gut Microbiota and Stool Frequency
Condition: Gut Microbiota
Study type: Observational

Summary: 
      We hypothesized that some difference in the composition and distribution of gut microbiota in
      people with a large number of defecation (two or three times a day or more), people with
      normal defecation (one time a day or two days), and people with a small number of defecation
      (two times a week or less).

      And we investigate the association between gut microbiota and stool frequency.
    

Detailed description: 
      We divided three groups. (total number = 60 subjects)

        1. a large number of defecation group (≥ 2-3 times/day) - 20 subjects

        2. normal defecation group (1 time/day or 1 time/2 days) - 20 subjects

        3. a small number of defecation group (≤ 2 times/week) - 20 subjects

      After collection of stools, we will analyze the composition and distribution of gut
      microbiota, and compared the results of three groups.
    

Intervention name(s): Stool frequency
Intervention type(s): Other
Intervention description(s): This study is just observational study.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy volunteers
      
Biospecimen description: 
      We will collect the stool from participants, and extract DNA from stool sample. We plan to
      acquire the Human Derivative Research Description.
    
Keywords: gut microbiota; stool frequency
Bioavailability Study of Ondansetron Orally Disintegrating Tablets Under Fasting Conditions
Condition: Healthy
MeSH terms: Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the single-dose bioavailability of Ondansetron 8 mg oDT and Zofran 8 mg ODT
    

Detailed description: 
      To Compare the single-dose bioavailability of Kali's Ondansetron 8 mg ODT with that of
      GlaxoSmithKine's Zofran 8 mg ODT under fasting conditions
    

Intervention name(s): Ondansetron; Zofran
Intervention type(s): Drug; Drug
Intervention description(s): ODT, 8 mg, single-dose; ODT, 8 mg, fasting conditions
Other intervention name(s): Zofran; Ondansetron ODT
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: bioequivalence; Ondansetron ODT; Fasting; To determine bioequivalence under fasting conditions
Visual Perception After Virtual Implantation
Condition: Healthy
Study type: Interventional

Summary: 
      Evaluation of visual perception through diffractive optical lens designs by virtual
      implantation.
    


Intervention name(s): Virtual implantation
Intervention type(s): Other
Intervention description(s): Temporary placement of virtual optical lens in the crystalline lens plane.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Walking Inclined Plane
Condition: Cerebral Palsy; Spastic Diplegia
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      The adaptations in kinematics and muscle activity, investigated by 3D gait analysis and
      dynamic electromyography recordings, will be studied in children with bilateral spastic
      cerebral palsy during level walking, and before and after a training on a treadmill with a
      sloped surface (7°). Data will be compared with those obtained in a sample of typically
      developing (TD) children (controls)
    

Detailed description: 
      15 CP children and 15 TD children aged 6 to 14 years will take part in this study. Dynamic
      EMG recordings will be performed as well as kinematic data assessments through a gait
      analysis system. Three different slopes will be assessed, using a treadmill. The primary
      outcome measure will be the minimal knee extension value in the stance phase. The changes in
      kinematics will be overall assessed through the Gait Profile Score (Baker et al.). The
      details in changes will be assessed through statistical parametric mapping (SPM). The changes
      in muscle activity induced by the slope will be investigated by statistical parametric
      mapping of the EMG or kinematic data.
    

Intervention name(s): walking on a treadmill with a sloped surface; treadmill
Intervention type(s): Procedure; Device
Intervention description(s): walking on a treadmill with a sloped surface; walking on a treadmill with a sloped surface
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cerebral palsy; gait; slope; electromyography
Efficacy of Yoga for Postpartum Depression
Condition: Depression, Postpartum
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The aim of this project is to compare the efficacy of an 8-week yoga intervention, relative
      to a wait-list control (WLC) condition, for improving psychological functioning and
      health-related quality of life in depressed postpartum women. It was hypothesized that the
      yoga intervention would be significantly more efficacious than the wait-list control
      condition in reducing symptoms of depression and anxiety, and improving health-related
      quality of life, at the end of the 8-week yoga intervention.
    


Intervention name(s): Yoga
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Yoga; Complementary and Alternative Medicine Interventions; Treatment; Postpartum Depression
Vitamin D Plus Fluticasone Propionate
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 4

Summary: 
      The objectives of this study would be to see if the addition of vitamin D to fluticasone
      propionate provides greater symptomatic relief in patients with seasonal allergic rhinitis
      compared to fluticasone propionate treatment alone.
    


Intervention name(s): Vitamin D3; Placebo; Fluticasone Propionate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 4000 IU once daily; Placebo taken once daily; 200 mcg daily, intranasal
Other intervention name(s): Flonase
Intervention MeSH terms: Vitamin D; Cholecalciferol; Fluticasone; Xhance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Respiratory Muscle Endurance in Obesity Hypoventilation Syndrome
Condition: Obesity Hypoventilation Syndrome (OHS)
MeSH terms: Hypoventilation; Obesity Hypoventilation Syndrome; Obesity; Syndrome
Study type: Observational

Summary: 
      Obesity hypoventilation syndrome (OHS) is defined as a combination of obesity [body mass
      index (BMI) ≥30 kg/m2], chronic daytime hypercapnia (PaCO2 >45 mm Hg), and sleep-apnea in the
      absence of other known causes of hypercapnia. Respiratory system compliance decreases and
      resistance increases in OHS. This causes increase in work of breathing and oxygen cost of
      breathing, which may result in respiratory muscle fatigue. Increase in respiratory workload
      and increase in resistance to respiration is expected to decrease in respiratory muscle
      endurance (RME) in subjects with OHS.
    

Detailed description: 
      In the literature, studies evaluating RME in subjects with OHS are limited. No study has been
      found to evaluate RME using the incremental load test in subjects with OHS. Accordingly, it
      was aimed to evaluate and compare respiratory muscle endurance in subjects with OHS and a
      control group, and to determine factors associated with respiratory muscle endurance.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All subjects who had polysomnography performed in the sleep laboratory and were diagnosed
        with OHS were screened.

        Age and sex-matched obese subjects (30 < body mass index < 40 kg/m2) with low risk of
        obstructive sleep apnea (STOP-BANG score < 3) included in the study as the control group.
      
Keywords: Respiratory Muscle Endurance; Sleep; Fatigue; Quality of Life
Study of Cardiovascular Disease and Obstructive Sleep Apnea
Condition: Severe Obstructive Sleep Apnea (Apnea Hypopnea Index > 30 Events/Hour); Hypertension
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Hypertension; Cardiovascular Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if two medicines (allopurinol and losartan) can
      influence heart and blood vessel health compared to placebo in patients with sleep apnea who
      are using continuous positive airway pressure (CPAP).
    

Detailed description: 
      The specific aims of this research project are: 1) Determine if treatment with losartan, an
      angiotensin type I receptor (AT1R) antagonist, or allopurinol, a XO inhibitor, normalize
      chemoreflex control of sympathetic outflow and ventilation and improve local vascular
      regulation and stiffness; and 2) Determine if these interventions reduce the severity of
      sleep disordered breathing and lower diurnal blood pressure.
    

Intervention name(s): Losartan; Allopurinol; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Losartan 50 mg daily for two weeks, then increased to 100mg daily for 4 weeks if asymptomatic. Remain at 50 mg daily for 4 more weeks or removed from study if symptomatic.; Allopurinol 300 mg daily for 6 weeks; Placebo capsule daily for 6 weeks
Intervention MeSH terms: Allopurinol; Losartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hypertension; High Blood Pressure; Sleep Apnea; Obstructive Sleep Apnea; OSA
Long-term Resveratrol and Metabolism
Condition: Pre-diabetes
MeSH terms: Prediabetic State
Study type: Interventional

Summary: 
      The main objective of the study is to investigate if 6 months resveratrol supplementation can
      improve glucose tolerance in overweight/obese individuals. As secondary objectives we want to
      investigate whether resting energy metabolism, intra-hepatic lipid content, physical
      performance, body composition and quality of life change by 6 months resveratrol
      supplementation in these individuals.
    


Intervention name(s): resveratrol; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Resveratrol will be given for 6 months, twice daily. One pill, which contains 75 mg of resveratrol, will be provided with lunch, and the other pill, also containing 75 mg will be given with dinner. So in total a dose of 150 mg/day will be given.; A placebo will given for 6 months, twice daily. One pill will be provided with lunch, and the other pill will be provided with dinner.
Other intervention name(s): resVida (99% trans-resveratrol)
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Resveratrol; Diabetes Mellitus, Type 2; Insulin Resistance; Metabolic Diseases; Glucose Metabolism Disorders
A Study of Pirfenidone in Patients With Unclassifiable Progressive Fibrosing Interstitial Lung Disease
Condition: Lung Diseases, Interstitial
MeSH terms: Lung Diseases; Lung Diseases, Interstitial
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of pirfenidone in
      participants with fibrosing interstitial lung disease (ILD) who cannot be classified with
      moderate or high confidence into any other category of fibrosing ILD by multidisciplinary
      team (MDT) review ("unclassifiable" ILD).
    

Detailed description: 
      Study participants will be randomised to receive 801 mg pirfenidone or placebo three times
      daily for 24 weeks. The efficacy of pirfenidone versus placebo will be assessed by daily
      measurement of forced vital capacity using a handheld spirometer over the treatment period.
      Additionally, the study will assess the efficacy and safety of pirfenidone with and without
      concomitant mycophenolate mofetil treatment and in study participants with or without
      interstitial pneumonia with autoimmune features (IPAF). All study participants who attend the
      follow-up visit at Week 28 will be offered the opportunity to receive open-label pirfenidone
      within the trial protocol. In order to maintain blinding of the controlled period of the
      study, all study participants will discontinue treatment by Week 24 and return for a
      follow-up visit 4 weeks later. Study participants eligible to participate in the single-arm
      12-month extension will be initiated on open-label pirfenidone during this visit (re-starting
      the dose titration from one capsule three times daily [TID]). During the long-term extension
      period, study participants will be monitored for safety, initially at monthly visits during
      the first 6 months and thereafter approximately every 3 months. A final follow-up visit will
      take place 4 weeks after the last dose of pirfenidone is taken.
    

Intervention name(s): Pirfenidone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pirfenidone 267 mg capsules three times in a day.; Matching placebo capsules three times in a day.
Intervention MeSH terms: Pirfenidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effect of Femoral Nerve Block on Opioid Requirements After Surgery for a Femur Fracture in Children
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates the effect of a femoral nerve block on opioid requirements following
      femoral fracture fixation with flexible nails in the paediatric population. This is a double
      blind, prospective randomized clinical trial.
    


Intervention name(s): Administration of a femoral nerve block (bupivacaine HCL)
Intervention type(s): Procedure
Intervention description(s): No details specified
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Femur fracture; morphine sparing; preemptive analgesia; Post-operative pain and post- operative opioid use
Dual bNAb Treatment in Children
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the impact of two broadly neutralizing antibodies,
      VRC01LS and 10-1074, on the maintenance of HIV suppression in a cohort of early-treated
      children in Botswana.
    

Detailed description: 
      This study will evaluate the impact of two broadly neutralizing antibodies, VRC01LS and
      10-1074, on the maintenance of HIV suppression in a cohort of early-treated children in
      Botswana.

      The primary objectives are as follows:

        1. To conduct an interventional clinical trial to determine the safety, pharmacokinetics,
           dosing and antiviral efficacy of up to 24 weeks of maintenance VRC01LS and 10-1074
           immunotherapy in early-treated HIV-1 infected children in Botswana.

        2. To evaluate effects of treatment with VRC01LS and 10-1074 on the size and cellular
           composition of residual viral reservoirs.

        3. To investigate the influence of VRC01LS and 10-1074 treatment on the magnitude and
           quality of antiviral innate and adaptive immune responses.

      The study includes 4 steps: the pharmacokinetics (PK) Step, Step 1, Step 2, and Step 3. In
      the PK Step, antiretroviral treatment (ART) is continued and 12 study participants will
      undergo safety and PK testing, 6 for each bNAb used in the study (10-1074 and VRC01LS). In
      Step 1, ART is continued and dual bNAb treatment occurs, with PK confirmation of dual bNAb
      dosing for the first 6 participants in Step 1. In Step 2, ART is withdrawn and dual bNAb
      maintenance treatment occurs. In Step 3, dual bNAbs will be discontinued and participants
      will be re-started on ART.

      Participants will be in the study for a minimum of 56 weeks, and a maximum of 98 weeks for
      those who start in the PK step and continue through the study.
    

Intervention name(s): ART; VRC01LS; 10-1074
Intervention type(s): Drug; Biological; Biological
Intervention description(s): ART will not be provided by the study. Participants will continue to receive their ART regimen they were receiving prior to enrolling in the study.; Administered by intravenous (IV) infusion; Administered by intravenous (IV) infusion
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: broadly neutralizing antibodies; HIV suppression
The Role of Genetic Factors in the Development of Bronchial Asthma in the Kazakh Population
Condition: Bronchial Asthma; Genome Wide Association Studies
MeSH terms: Asthma
Study type: Observational

Summary: 
      To research for a genetic marker of bronchial asthma, a single nucleotide polymorphism (SNP)
      analysis of DNA obtained from the peripheral blood of patients with bronchial asthma and
      normal control will be performed.
    

Detailed description: 
      Unrelated Kazaks subjects who have bronchial asthma were recruited in the current study.
      Genotyping for various SNP associated due to the linkage disequilibrium patterns is to be
      performed. Genotypes would be statistically compared between patients with bronchial asthma
      and normal control subjects free of bronchial asthma
    

Intervention name(s): SNP analysis of the DNA
Intervention type(s): Genetic
Intervention description(s): SNP analysis of the DNA obtained from peripheral blood sample
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Persons with bronchial asthma confirmed by a doctor
      
Biospecimen description: 
      blood
    
Keywords: Bronchial Asthma; Genome Wide Association Studies
Proportional Assist Ventilation (PAV) in Early Stage of Critically Ill Patients
Condition: Respiratory Failure; Mechanical Ventilation
MeSH terms: Respiratory Insufficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the effectiveness of high assistance proportional assist ventilation (PAV+)
      (objective 80% gain) as main ventilatory support in early stage of critically ill patients in
      comparison with standard volume-assist control ventilation (ACV).
    

Detailed description: 
      The goal of this proposal is to apply PAV+ as routine ventilatory mode in the early stage of
      critically ill patients, taking advantages of spontaneous breathing and better
      patient-ventilator interaction.

      The standard treatment in patients with acute respiratory failure is mechanical ventilation
      in control-mode for the first days of acute illness. This procedure is usually associated
      with patient-ventilator dyssynchrony, higher needs of sedation and/or relaxation, muscle
      atrophy, etc. PAV + is a new ventilatory mode that applies pressure in proportion to
      spontaneous patient inspiratory effort allowing better adaptation to changes in internal
      homeostasis.

      Up to now, several reports compare PAV with assisted modes as a feasible alternative only in
      the weaning phase. However, PAV is able to unload patient effort in different levels,
      suggesting that high-assistance PAV (about 80%) could be comparable with assist-control modes
      in terms of respiratory muscles unload.

      Whether PAV is as effective as traditional ACV in terms of ventilation muscle unload in the
      acute phase of illness has not been established and we aim to address this question.

      We plan to prospectively enroll patients on mechanical ventilation early at ICU admission,
      and to ventilate them randomly under ACV (volume-assist control ventilation) or PAV+
      (beginning with 80% if possible). We will evaluate length of mechanical ventilation, sedation
      requirements and respiratory-hemodynamic variables from the very beginning and until
      attending clinicians decide that patients are ready to be weaned.
    

Intervention name(s): Mechanical ventilation mode (PAV+ vs. ACV)
Intervention type(s): Other
Intervention description(s): Compare two ventilatory modes in the acute phase of illness
Other intervention name(s): Proportional Assist ventilation (PAV+); Assist Control ventilation; Critically ill patients; Mechanical ventilation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Proportional Assist Ventilation plus; Acute respiratory failure; Mechanical ventilation