bioihbjkbjnl/mcl2 huggingface dataset:
Preemie Hypothermia for Neonatal Encephalopathy
Condition: Infant, Newborn; Hypoxia, Brain; Hypoxia-Ischemia, Brain; Encephalopathy, Hypoxic-Ischemic; Hypoxic-Ischemic Encephalopathy; Ischemic-Hypoxic Encephalopathy
MeSH terms: Brain Diseases; Brain Ischemia; Hypoxia-Ischemia, Brain; Hypoxia, Brain; Ischemia; Hypoxia; Hypothermia
Study type: Interventional

Summary: 
      This study is a randomized, controlled trial to assess safety and effectiveness of whole body
      hypothermia for 72 hours in preterm infants 33-35 weeks gestational age (GA) who present at
      <6 hours postnatal age with moderate to severe neonatal encephalopathy (NE). The study will
      enroll infants with signs of NE at 18 NICHD Neonatal Research Network sites, and randomly
      assign them to either receive hypothermia or participate in a non-cooled control group.
    

Detailed description: 
      Most clinical studies of neonatal encephalopathy (NE) and potential interventions have
      focused on infants ≥36 weeks GA. Although many interventions have been suggested and assessed
      for prevention or palliation of NE, the only one currently supported by rigorous clinical
      evidence to improve outcome in human newborns has been hypothermia implemented at <6 hours of
      postnatal age and maintained for 72 hrs. Data about diagnosis, frequency, severity, and
      outcome of NE in infants 33-35 weeks GA are sparse.

      This trial will assess safety and effectiveness of whole body hypothermia for 72 hours in
      preterm infants 33-35 weeks gestational age (GA) who present at <6 hrs postnatal age with
      moderate to severe neonatal encephalopathy. Infants 33 0/7 to 35 6/7 weeks GA (best
      obstetrical estimate) and greater than or equal to 1500 grams birth weight (selected to
      minimize potential difficulties placing esophageal probe) who meet clinical, biochemical and
      neurologic criteria for moderate to severe NE will be randomized to either whole body
      hypothermia or participate in a non-cooled control group. The primary outcome will be death
      or moderate to severe disability at 18-22 months corrected age. The presence or absence of
      disability will be determined by the standard NRN interdisciplinary follow-up exam.

      Secondary Study includes determining an association between MRI detectable injury and
      neurodevelopment at 18-22 months.
    

Intervention name(s): Hypothermia; Normothermic Control
Intervention type(s): Device; Procedure
Intervention description(s): Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 72 hours; Normothermic Control group (with esophageal temperature at or near 37.0°C) for 96 hours
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NICHD Neonatal Research Network; Hypoxic-ischemic encephalopathy (HIE); Hypothermia; Neonatal depression; Perinatal asphyxia
Tracheal Tube Cuff Shape and Pressure
Condition: Intubation, Intratracheal; Pain, Postoperative; Dysphonia
MeSH terms: Dysphonia; Pain, Postoperative
Study type: Interventional

Summary: 
      This is a randomized controlled trial focusing on the effect of different tracheal tube cuff
      shape; the tapered-shaped tracheal tube cuff versus the cylindrical-shaped tracheal cuff in
      anterior cervical spine surgery.
    

Detailed description: 
      High endotracheal cuff pressure (ETCP) during surgical retractor splay associates with
      recurrent laryngeal nerve paresis/ palsy and results in post-anterior cervical spine surgery
      (post-ACSS) dysphonia. Control of intraoperative ETCP during ACSS may benefit voice outcome.
      The taper-shaped tracheal tube cuff was originally designed as a new strategy to reduce fluid
      leakage across the conventional cylindrical cuff and prevention of ventilator associated
      pneumonia. Literature has revealed the just seal pressure for the tapered-shaped tracheal
      tube (TT) cuff was lower than conventional cylindrical cuff. Therefore the investigators
      hypothesize that use of a tapered-shaped ET cuff during the surgery can lead to a lower ETCP
      during retractors splay and improve voice recovery after ACSS. In this study, 80 patients
      were randomized into 2 groups, to receive endotracheal intubation using TaperGuard tracheal
      tube (tapered- shaped cuff) or a conventional tracheal tube (a cylindrical cuff). The just
      seal pressure, intraoperative cuff pressure, and postoperative sore throat and voice outcome
      are recorded and compared.
    

Intervention name(s): Different tracheal tube cuff design
Intervention type(s): Device
Intervention description(s): Comparison of effect between 2 different designs of tracheal tube cuff
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
A Study to Evaluate the Effectiveness of MEDI-563 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Chronic Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the effect of the drug in moderate to severe Chronic Obstructive Pulmonary
      Disease (COPD) in Adults.
    

Detailed description: 
      To evaluate the effect of multiple subcutaneous (SC) doses of benralizumab (MEDI 563) on the
      rate of moderate-to-severe annualized incidence rate of moderate or severe acute
      exacerbations of chronic obstructive pulmonary disease (AECOPD) in adult subjects with
      moderate-to-severe COPD who exhibit eosinophilia (greater than or equal to [>=] 3.0 percent
      [%] sputum eosinophilia in the previous 12 months or at Screening) in sputum compared to
      placebo.
    

Intervention name(s): Placebo; Benralizumab 100 mg
Intervention type(s): Other; Biological
Intervention description(s): Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).; Benralizumab (MEDI-563) 100 mg injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
Other intervention name(s): MEDI-563
Intervention MeSH terms: Benralizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Benralizumab; MEDI-563; Pulmonary Disease, Chronic Obstructive
Mesenchymal Stem Cell Based Therapy for the Treatment of Osteogenesis Imperfecta
Condition: Osteogenesis Imperfecta
MeSH terms: Osteogenesis Imperfecta
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety and effectiveness of five infusions of
      characterized HLA-identical MSC in non immunosuppressed children with Osteogenesis Imperfecta
      (OI).
    

Detailed description: 
      The principal aim of this trial is to assess the safety of non-mutated HLA-identical
      Mesenchymal stem cell (MSC) transplantation for OI pediatric patients irrespective of
      treatment with biphosphonates. Since MSC are inherently non-immunogenic and do not elicit
      proliferation of allogeneic lymphocytes (in co-culture experiments), a cell therapy based on
      HLA-identical or histocompatible (at least 5 shared out of 6 HLA antigens) allogenic MSC may
      be accomplished without subjecting the patients to immunosuppressor treatment. Adverse
      secondary effects due to immunosuppressor treatment will be avoided using this strategy thus
      patients may benefit from two cellular infusions. The patients will be followed for 2 years
      post their fifth and last MSC infusion.
    

Intervention name(s): Mesenchymal Stem Cells
Intervention type(s): Biological
Intervention description(s): Mesenchymal Stem Cell Infusions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mesenchymal stem cell based therapy; cell infusion
Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Mild or Moderate COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 3

Summary: 
      Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Mild or Moderate
      COVID-19
    

Detailed description: 
      Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Efficacy
      and Safety of Nitazoxanide in the Treatment of Mild or Moderate COVID-19
    

Intervention name(s): Nitazoxanide; Placebo; Vitamin Super B-Complex
Intervention type(s): Drug; Drug; Dietary Supplement
Intervention description(s): Two nitazoxanide 300 mg tablets administered orally twice daily with food for 5 days; Two placebo tablets administered orally twice daily with food for 5 days; Vitamin Super B-Complex administered orally twice daily to maintain the blind
Other intervention name(s): NTZ (nitazoxanide); NT-300
Intervention MeSH terms: Nitazoxanide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Human Gut Microbiota and Prebiotic Response
Condition: Healthy Gut Microbiota
Study type: Interventional

Summary: 
      This study is designed to examine the shift in gut microbiota and their metabolism after
      consumption of a dietary supplement (prebiotic) by healthy participants. The investigators
      will provide participants with a panel of over the counter prebiotics and monitor their gut
      microbiome response in stool. All prebiotics will be commercially available, over-the-counter
      food, food additives, or dietary supplements, without any known market-use adverse effects
      beyond minimal discomfort.
    


Intervention name(s): Prebiotic A - inulin; Prebiotic B - galactooligosaccharides(GOS); Prebiotic C - wheat dextrin
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Pre-weighed packages will be given twice daily for 5 days.; Pre-weighed packages will be given twice daily for 5 days.; Pre-weighed packages will be given twice daily for 5 days.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Improved Diagnosis of Alzheimer's Disease Using the Synchronous Neural Interaction™ Test
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Observational

Summary: 
      This study is designed to test the hypothesis that the Synchronous Neural Interaction™ Test
      is useful for diagnosing Probable Alzheimer's Disease according to standard criteria.
      Subjects diagnosed with Alzheimer's Disease as well as age-matched normal control subjects
      will be evaluated for symptoms of Alzheimer's Disease and those meeting inclusion criteria
      will undergo a brief, non-invasive scan of brain function using a magnetoencephalography
      (MEG). The scan itself lasts 1 minute while the subject is asked to stare at a dot projected
      in front of them on a video screen. Orasi Medical believes that patterns of brain activity
      measured at rest are indicative of Alzheimer's Disease pathology.

      The protocol is amended to add a follow-up assessment for previously enrolled and completed
      subjects who agree to participate in the follow-up assessment approximately 9 - 15 months
      after initial study enrollment. Subjects who agree to participate in the follow-up assessment
      will undergo the same standardized tests and MEG scan procedure as completed in the initial
      study.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be referred from dementia/Alzheimer's Disease clinical patients at study
        sites.
      
Keywords: Alzheimer's Disease; Diagnosis; Neuronal function; Cognitive Impairment; Magnetoencephalography
Multi-pronged Ethanol Ablation and Radiofrequency Ablation of Early-stage Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effectiveness of percutaneous ethanol ablation
      using a multi-pronged needle (QFEA) with that of percutaneous radiofrequency ablation (RFA)
      in the treatment of early-stage hepatocellular carcinoma (HCC).
    

Detailed description: 
      Patients with early-stage (single tumor no more than 5 cm or up to 3 tumors each no more than
      3 cm in size) primary hepatocellular carcinoma will be randomized into two percutaneous
      ablation treatment arms, including radiofrequency ablation and multi-pronged ethanol
      ablation. The local treatment responses, complications,and long-term disease-free survivals
      and overall survivals are analyzed.
    

Intervention name(s): multi-pronged ethanol ablation; radiofrequency ablation
Intervention type(s): Procedure; Procedure
Intervention description(s): Under ultrasound guidance, insert an applicator into the tumor percutaneously and then inject ethanol to destroy the whole tumor tissue.; Under ultrasound guidance, insert an applicator into the tumor percutaneously and then deliver radiofrequency energy to destroy the whole tumor tissue.
Intervention MeSH terms: Ethanol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: hepatocellular carcinoma; PEI; RF ablation; tumor ablation
Exploring Folk Health Practices in Latinos With Chronic Medical Conditions
Condition: Diabetes; Hypertension; Asthma; Heart Disease; Stroke; Arthritis
MeSH terms: Heart Diseases
Study type: Observational

Summary: 
      This study will explore how culture influences the use of folk healing practices and medical
      services in Latinos with chronic medical conditions.
    

Detailed description: 
      Sociocultural aspects of using ethnomedical health practices in a community-based Latino
      population will be described using both qualitative and quantitative survey methods. This
      study will rely heavily on its descriptive section, which will use in-depth, open-ended
      questions in a semi-structured personal interview format following qualitative research
      principles. It will also use closed-ended questions in a short survey format to begin to
      explore some variables that may be associated with using traditional healing practices. These
      variables include level of acculturation, degree of family social support, degree of
      adherence to standard medical regimens, perceived health status, presence of depressive
      symptoms, and severity of co-illnesses. These variables will be examined using common,
      validated scales.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants will be self-identified, adult Latino men and women from the community
        setting. The sample will comprise of a convenience sample from community-based
        organizations, including persons of Mexican, Puerto Rican, Cuban, Dominican, Central
        American, South American, or other Spanish-speaking culture.
      
Keywords: Latino patients; Health practices; Culture influences
Study to Evaluate the Effect Single and Multiple Oral Doses of BIRT 2584 XX Tablets on the Pharmacokinetic Parameters of Amitriptyline and Nortriptyline in Healthy Male and Female Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study was evaluate that there is no clinically relevant interaction
      between amitriptyline (or its metabolite nortriptyline) and BIRT 2584 XX (or its metabolite
      BI 610100) when BIRT 2584 XX is administered as a tablet formulation to near steady state in
      an estimated high therapeutic dose. Pharmacokinetics (PK) of amitriptyline and nortriptyline
      were measured before dosing of BIRT 2584 XX, after the first dose of BIRT 2584 XX, and after
      repeated doses of BIRT 2584 XX near steady state
    


Intervention name(s): BIRT 2584 XX; Amitriptyline
Intervention type(s): Drug; Drug
Other intervention name(s): Saroten®
Intervention MeSH terms: Amitriptyline
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Multiple Doses of ABT-072 Used to Treat Hepatitis C
Condition: HCV Infection
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine multiple dose safety, tolerability and
      pharmacokinetics of ABT-072 under nonfasting conditions in healthy adult subjects, and to
      determine the effect of single dose administration of ketoconazole on steady state ABT-072
      pharmacokinetics.
    

Detailed description: 
      Phase 1, Blinded, Randomized, Placebo-controlled Study in Healthy Adult Subjects to Evaluate
      the Safety, Tolerability, and Pharmacokinetic Profiles of Multiple Doses of ABT-072
    

Intervention name(s): ABT-072; ketoconazole; Placebo
Intervention type(s): Drug; Other; Drug
Intervention description(s): Powder contents from capsules mixed in an alternative vehicle, for additional information refer to Arm Description.; Tablet, see Arm Description for intervention information.; Capsule or powder drug substance from the capsule mixed in an alternative vehicle, for additional information refer to Arm Description.
Intervention MeSH terms: Ketoconazole
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Ixabepilone in Treating Patients With Relapsed and/or Refractory Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer
Condition: Ovarian Cancer; Peritoneal Cavity Cancer
MeSH terms: Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop
      tumor cells from dividing so they stop growing or die.

      PURPOSE: Phase II trial to study the effectiveness of ixabepilone in treating patients who
      have relapsed and/or refractory stage III or stage IV ovarian epithelial cancer or primary
      peritoneal cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the antitumor activity of ixabepilone, in terms of clinical response and
           progression-free survival, in patients with relapsed and/or refractory stage III or IV
           ovarian epithelial or primary peritoneal cancer.

        -  Determine the nature and degree of toxicity of this drug in these patients.

      Secondary

        -  Correlate pre-ixabepilone survivin mRNA and protein levels in patient-derived ovarian
           cancer cells with quality of response (i.e., at least partial response vs no response).

        -  Correlate CYP3A4 (3A4*1B), 3A5 (3A5*1), and 3A7 (ER6 p variation) allelic polymorphisms
           with parent drug kinetic parameters, toxicity, and efficacy of this drug in these
           patients.

      OUTLINE: This is a multicenter study.

      Patients receive ixabepilone IV over 1 hour once weekly on weeks 1-3. Treatment repeats every
      4 weeks for a total of 3 courses in the absence of disease progression or unacceptable
      toxicity.

      PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 12 months.
    

Intervention name(s): ixabepilone
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage III ovarian epithelial cancer; stage IV ovarian epithelial cancer; recurrent ovarian epithelial cancer; peritoneal cavity cancer
Dexmedetomidine-propofol-remifentanil Anaesthesia and Reactivity to Noxious Stimuli
Condition: Anaesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      Dexmedetomidine acts at central nervous system (specifically: at locus caeruleus), providing
      sedative and analgesic effects. It is widely used in intensive care. Surgery-related
      interventions elicit arousal ('nociceptive') reactions. The effects of dexmedetomidine on the
      neurophysiological signs of arousal are studied in surgical patients. Brain waves,
      electrocardiogram, Entropy Index, Bispectral Index, and fingertip pulse waves are recorded
      and analyzed later on. The course of anaesthesia and surgery are recorded.
    

Detailed description: 
      The patients are randomized to receive either dexmedetomidine or saline infusion before and
      during anaesthesia (dexmedetomidine 0.1 mcg/kg within 10 minutes, thereafter 0.7 mcg/kg/h
      until 30 min after skin incision).

      Multi-channel EEG, Entropy, BIS, multi-channel EMG, ECG, and plethysmogram are recorded on
      computer. Anaesthesia and surgery associated events are annotated on computer.

      Time points of endotracheal intubation, skin incision, and course of surgery well be analyzed
      in detail. Additionally, tetanic stimulus of ulnar nerve will be applied for each patient,
      and reactions to the stimulus will be analyzed.
    

Intervention name(s): Dexmedetomidine; Saline
Intervention type(s): Drug; Drug
Intervention description(s): Dexmedetomidine infusion 1 mcg/kg in 10 minutes; thereafter 0.7 mcg/kg/h until 30 minutes has elapsed from skin incision.; Saline infusion 1 mcg/kg in 10 minutes; thereafter 0.7 mcg/kg/h until 30 minutes has elapsed from skin incision.
Other intervention name(s): Precedex. CAS 113775476.
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Nociception; Dexmedetomidine; Electroencephalogram; Electromyogram; Entropy Index; Bispectral Index; Electrocardiogram; Plethysmogram; Heart; Heart rate; Heart rate variability; Surgery
OD vs. TID Dosing With Mesalazine Granules in Active Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      To proof the therapeutic equivalence of once daily (OD) versus three times daily (TID) dosing
      of total 3.0 g mesalazine granules in patients with active ulcerative colitis
    


Intervention name(s): mesalazine
Intervention type(s): Drug
Intervention MeSH terms: Mesalamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Stress During Elective or Emergency Cesarean Operations
Condition: Anxiety
MeSH terms: Emergencies
Study type: Observational [Patient Registry]

Summary: 
      We investigated a correlation between maternal anxiety and age, body mass index (BMI),
      parity-gravidity, patient satisfaction, antenatal care, postoperative pain according to
      emergent or elective C/S under general anesthesia.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study included pregnant women aged ≥18 years (gestational age: 37-40 weeks) in whom
        emergent or elective C/S was indicated
      
Keywords: cesarean operation; Spielberger State Trait Anxiety Inventory; pain