bioihbjkbjnl/mcl2 huggingface dataset:
Hyoscine Butylbromide for Prevention of Bradycardia During Cesarean Section
Condition: Bradycardia; Spinal Anesthetics Causing Adverse Effects in Therapeutic Use; Cesarean Section Complications
MeSH terms: Bradycardia
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to assess the efficacy of Iv hyoscine butylbromide in preventing
      Bradycardia during cesarean section under spinal anaesthesia with local anaesthetic and
      morphine.
    


Intervention name(s): Hyoscine Butylbromide 20 Mg/mL Solution for Injection Ampoule; Normal saline
Intervention type(s): Drug; Other
Intervention description(s): Patients will receive IV study solution which is hyoscine butylbromide 20 mg in 1 ml one minute after spinal anaesthesia; Patients will receive 1 ml of IV normal saline as a placebo one minute after spinal anesthesia
Intervention MeSH terms: Scopolamine; Butylscopolammonium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
A Study of Acne Treatment in Children Ages 9 to 11
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 2

Summary: 
      A study to determine if using Retin-A Micro 0.04% as facial acne treatment in patients ages 9
      to 11 is safe and efficacious.
    

Detailed description: 
      Approximately 100 female and male subjects, aged from 9 to 11 years of age, will be enrolled
      in this randomized, double blind, multi-center study.

      Following satisfaction of entry criteria and screening procedures, subjects will receive
      either RETIN-A MICRO 0.04% or a color matched gel vehicle for once daily use during the
      12-week treatment period. Subjects will be monitored for safety throughout the study and for
      signs and symptoms of local irritation at baseline, and at weeks 2, 4, 6, 8, 10 and again at
      study completion, week 12.

      Efficacy will be assessed by facial lesion counts and by utilizing scales for Investigator's
      Global Evaluation of Acne Severity (IGA #1 and IGA #2) and Investigator's Global Assessment
      of Improvement (IGA #3). All efficacy parameters with the exception of IGA #3 will be
      measured at baseline and weeks 2, 4, 6, 8, 10 and 12. The Investigator's Global Assessment of
      Improvement (IGA #3) will be done at Week 12 only. At selected sites, photographs will be
      taken at Baseline and weeks 2, 4, 8 and 12.
    

Intervention name(s): Retin-A Micro 0.04% facial acne treatment; Vehicle control
Intervention type(s): Drug; Drug
Intervention description(s): Retin-A Micro 0.04% facial acne treatment used once daily; Color-matched facial gel vehicle control used once daily
Other intervention name(s): facial acne treatment; placebo
Intervention MeSH terms: Tretinoin; Benzoyl Peroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: acne; irritation; objective sensory methods
Effects of Mometasone Furoate Dry Powder Inhaler, Fluticasone Propionate, and Montelukast on Bone Mineral Density in Asthmatics (Study P03418)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a randomized, multi-center, parallel-group, active-controlled, double-blind study
      evaluating the effects of mometasone furoate (MF) dry powder inhaler (DPI) on bone mineral
      density (BMD) in subjects with asthma. The mean percent change in lumbar spine BMD from the
      averaged baseline value (the average of the two scan results prior to treatment) to the
      endpoint of treatment time point (the average of the last two valid post-baseline scan
      results during treatment) for the comparison of MF DPI 400 mcg daily in the evening versus
      montelukast (ML) 10 mg daily in the evening.
    


Intervention name(s): mometasone furoate dry powder inhaler; mometasone furoate dry powder inhaler; fluticasone propionate hydrofluoroalkane (HFA); montelukast
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 400 mcg MF DPI via a breath-actuated, dry-powder inhaler and a placebo tablet given by mouth once daily in the evening for 1 year.; 200 mcg MF DPI via a breath-actuated, dry-powder inhaler and a placebo tablet given by mouth once daily in the evening for 1 year.; 250 mcg FP HFA given twice a day via a metered-dose inhaler and a placebo tablet given once daily in the evening for 1 year; 10 mg given once daily in the evening by mouth for 1 year.
Other intervention name(s): Asmanex; Asmanex; Flovent HFA; Singulair
Intervention MeSH terms: Fluticasone; Xhance; Mometasone Furoate; Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Vitamin D Levels and Vitamin D Education in Geriatric Patients
Condition: Vitamin D Insufficiency; Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      Vitamin D is important to maintain good health. Although it is found in foods and vitamins,
      many people still have low vitamin D levels. One purpose of this study is to describe vitamin
      D levels from patients at the University of Colorado Seniors Clinic. Another goal of the
      study is to find out if education by a pharmacist can increase vitamin D levels in patients
      who have low vitamin D levels.
    


Intervention name(s): Pharmacist Education about Vitamin D
Intervention type(s): Behavioral
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: vitamin D deficiency; geriatric patients
Safety Study of Oral Pirfenidone in Patients With Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis
Condition: Idiopathic Pulmonary Fibrosis; Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the safety of treatment with pirfenidone (up to 3600 mg/d) in patients with
      pulmonary fibrosis/idiopathic pulmonary fibrosis (PF/IPF).
    

Detailed description: 
      This study has been designed as a rollover study to collectively include safety data from
      various previous studies.

      In addition, InterMune has also initiated an Early Access Program to make pirfenidone
      available to a limited number of patients with idiopathic pulmonary fibrosis in the United
      States. This program is also being conducted under this protocol. Registration of patients
      with documented IPF has been closed as of October 2005.
    

Intervention name(s): Pirfenidone
Intervention type(s): Drug
Intervention description(s): up to 3600 mg/day of pirfenidone given orally administered in divided doses three times daily with food, for the duration of the study
Intervention MeSH terms: Pirfenidone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: pulmonary fibrosis; respiratory diseases
Vestipitant 28-day Tolerance Study
Condition: Sleep Disorders
MeSH terms: Sleep Wake Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a 28-day polysomnographic and subjective assessment of oral Vestipitant
      15mg/day for treatment of Primary Insomnia in adults outpatients.
    


Intervention name(s): GW597599; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GW597599 15mg tablet; Placebo to match GW597599 15mg tablet
Intervention MeSH terms: Vestipitant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Polysomnography (PSG); Adults; Primary Insomnia
Respiratory Consequences of N95-type Mask Usage in Pregnant Healthcare Workers - A Controlled Clinical Study
Condition: Hypoventilation
MeSH terms: Hypoventilation
Study type: Interventional

Summary: 
      The study aims to find out if usage of N95 type respirators affects respiratory parameters in
      pregnant women so as to provide guidance on N95 respirator usage in pregnant healthcare
      workers.
    

Detailed description: 
      The first phase of the study aims to determine the average workload of a nurse. In the second
      phase of the study, this workload is then translated to walking on a treadmill while pregnant
      subjects wore special masks open to air, then occluded with N95 mask materials.
    

Intervention name(s): N95 mask
Intervention type(s): Device
Intervention description(s): N95 mask material used to cover aperture of Hans Rudolph mask
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: filtering facepiece respirators; N95 masks; pandemic response; pregnant healthcare workers
Food Effect Study of AG-221 in Healthy Male Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      AG-221 is a first-in-class drug targeted specifically to inhibit the IDH2 enzyme. Small
      molecule inhibition of the IDH enzyme represents a new, targeted approach to cancer
      treatment.

      Administration of oral drugs with food may change the absorption of drugs, and it is
      therefore useful to characterize the effect of food early in drug development.
    


Intervention name(s): AG221
Intervention type(s): Drug
Intervention description(s): AG221 in fed and fasted conditions
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy volunteers
An Interactive Preventive Health Record (IPHR) to Promote Patient-Centered Preventive Care
Condition: Prevention
Study type: Interventional

Summary: 
      Americans only receive 50% of indicated preventive services. We hypothesize that an
      interactive preventive health record (IPHR) will increase the delivery of recommended
      screening tests, immunizations, and counseling. The IPHR will function as a highly
      sophisticated personal health record for prevention, linking patients directly to their
      health information in the electronic record of their primary care physician. The functions of
      the IPHR will extend beyond those of personal health records by providing tailored
      recommendations, links to educational resources and decision aids, and patient and clinician
      reminders. Year one will focus on updating and refining an existing IPHR prototype. The
      second and third year, through a randomized controlled trial, will examine the effectiveness
      of the IPHR. Outcomes will include (1) whether the IPHR increases the delivery of recommended
      preventive services, (2) whether participants use the IPHR, and (3) whether the IPHR
      increases shared decision-making and improves clinician-patient communication. The study will
      take place in seven primary care practices in the Virginia Ambulatory Care Outcomes Network
      (ACORN) that utilize a common electronic medical record (EMR). A randomly selected sample of
      5,500 of the practices' 228,000 patients, stratified by age and gender, will be assigned in a
      one-to-one ratio to receive a request from their clinician to use the IPHR (intervention
      group) or receive "usual" preventive care (control group). A Preventive Services Survey,
      which uses standardized questions to evaluate the delivery of preventive care, will be mailed
      to 4,500 patients and the CAHPS Clinician & Group Survey will be mailed to 1,000 patients.
      Surveys will be mailed pre-intervention, 6 month post-intervention, and 18 months
      post-intervention. Delivery of preventive care will be measured by the Preventive Services
      Survey and EMR data, while shared decision-making and clinician-patient communication will be
      measured by the CAHPS survey. The change from baseline to 6 and 18 months post-intervention
      for the control and intervention groups will be compared.
    


Intervention name(s): Interactive Preventive Health Record (IPHR); "Standard" preventive care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Preventive health record designed to a) show patients the status of their preventive care recorded in their electronic record and b) make recommendations on what USPSTF endorsed preventive services that the user needs to receive.; Existing mechanisim for receiving preventive care in primary care (i.e. patients not referred to the IPHR).
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Preventive Care; Health information technology; Personal health record
A Study Evaluating the Immunogenicity of Different Clinical Trial Materials of Ad26.RSV.preF- Based Vaccine in Adults Aged 60 - 75 Years Old
Condition: Respiratory Syncytial Virus Prevention
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate non-inferiority in terms of humoral immune
      responses induced by vaccination with one dose of the Phase 3 clinical trial material (CTM)
      compared with one dose of the Phase 2b CTM.
    


Intervention name(s): Ad26.RSV.preF-based vaccine
Intervention type(s): Biological
Intervention description(s): Ad26.RSV.preF-based vaccine will be administered as a single intramuscular injection.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Ziv-aflibercept Efficacy in Better Regulating AMD
Condition: Wet Macular Degeneration; Wet Age-related Macular Degeneration
MeSH terms: Macular Degeneration; Wet Macular Degeneration
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, open-label, interventional, controlled study to determine the effects
      of Zaltrap on Neovascularized Wet Macular Degeneration as compared to the control
      anti-vascular endothelial growth factor ("anti-VEGF") injections (bevacizumab, ranibizumab,
      or aflibercept).
    


Intervention name(s): Ziv-Aflibercept 25 MG/ML [Zaltrap]; Ranibizumab
Intervention type(s): Drug; Drug
Intervention description(s): Anti-VEGF injection; Anti-VEGF standard of care injection
Other intervention name(s): aflibercept; bevacizumab
Intervention MeSH terms: Ranibizumab; Aflibercept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neovascularization
Anti-malaria MAb in Mali
Condition: Plasmodium Falciparum Infection; Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and efficacy of VRC
      MALMAB0100-00-AB (CIS43LS), a human monoclonal antibody, against naturally occurring
      Plasmodium falciparum (Pf) infection.
    

Detailed description: 
      This study will evaluate the safety, tolerability, and efficacy of VRC MALMAB0100-00-AB
      (CIS43LS), a human monoclonal antibody, against naturally occurring Plasmodium falciparum
      (Pf) infection.

      The first part of the study is an open-label dose-escalation study for safety and
      tolerability. Participants will be assigned to one of three dose arms. Dosing will begin in
      the lowest dose arm. Once all participants in that arm reach Day 7 post-infusion, if no
      safety concerns have arisen, dosing will begin at the subsequent dose level. This process
      will be repeated until participants complete the third dose arm. Participants will be
      followed for safety to assess adverse events (AEs) at study visits 1, 3, 7, 14, 21, and 28
      days after administration, then monthly through 24 weeks after administration.

      After the last subject in the highest dose arm reaches Day 7 safety follow-up, an interim
      safety evaluation will be performed before enrollment begins for the second part of the
      study.

      The second part of the study is a randomized, double-blind, placebo-controlled trial to
      assess safety and protective efficacy of CIS43LS and placebo. Participants in the efficacy
      study will receive the study agent and be followed at study visits 1, 3, 7, 14, 21, and 28
      days later, and once every 2 weeks thereafter through 24 weeks. Primary study assessments
      include physical examinations and blood collection for identification of Pf infection and
      other research laboratory evaluations.
    

Intervention name(s): VRC-MALMAB0100-00-AB (CIS43LS); Normal saline
Intervention type(s): Biological; Other
Intervention description(s): Administered via one-time IV infusion; Administered via one-time IV infusion
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
ImmuneSense COVID-19 Variant Study
Condition: Covid19
MeSH terms: COVID-19
Study type: Observational

Summary: 
      This study will assess the clinical performance of the T-Detect™ COVID test to identify an
      immune response to SARS-CoV-2 infection in the setting of multiple circulating variants of
      the SARS-CoV-2 virus. Performance may vary depending on the variants circulating at the time
      of testing, including newly emerging strains of SARS-CoV-2 and their prevalence, which
      changes over time.
    


Intervention name(s): T-Detect COVID test
Intervention type(s): Device
Intervention description(s): • The T-DetectTM COVID test is an EUA granted investigational device that is indicated to assess a T-cell immune response to SARS-CoV-2 via the testing of blood samples from patients with signs and symptoms of suspected COVID-19.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Prospective ascertainment of a target of 50 whole blood samples (1 sample per individual),
        and a maximum number of 250 whole blood samples, from individuals between the ages of 18-89
        who reside within the United States who have tested positive for SARS-CoV-2 infection via
        RT-PCR test.

        Pregnant women, prisoners, mentally disabled persons, and wards-of-the-state will be
        excluded to prevent any risk to these vulnerable populations.
      
Biospecimen description: 
      Whole blood will be collected in volumes of 5 mL (1 x 10 mL K2 EDTA tube) for each
      participant. It will be considered a protocol deviation if less than 2mL of whole blood is
      collected per tube All whole blood samples collected during the study visit will be shipped
      ambiently to Adaptive. Upon arrival at Adaptive, blood will undergo DNA extraction, and the
      T-Detect TM COVID test will be performed as applicable and per laboratory protocols.
      Additional assays may be applied.
    
Keywords: Variant
Initial Investigation of [18F]P17-059 in Parkinson's Disease Patients and Healthy Volunteers
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study investigates the initial safety profile of [18F]P17-059 in healthy volunteers
      including dosimetry determination, and compares regional brain uptake and kinetics of
      [18F]P17-059 in Parkinson's disease patients with regional brain uptake and kinetics of
      [18F]P17-059 in healthy volunteers.
    


Intervention name(s): [18F]P17-059
Intervention type(s): Drug
Intervention description(s): Injection of < 10 mCi [18F]P17-059 followed by PET/CT scanning
Other intervention name(s): [18F]D6FP; [18F]D6FPDTBZ
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Zirconia and Metal-based Single Crown Posterior Restorations.
Condition: Dental Crowns; Dental Prosthesis; Prosthodontics
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study was to compare the 5-year survival and clinical behavior of
      single posterior ceramic crowns made with pressable ceramic on zirconia or on a metal
      framework. If failures occurred, the further aim of the study was to delineate the factors
      contributing to the failure. The null hypothesis stated that the survival of zirconia-based
      restorations would be no worse that those made with metal-based material.
    


Intervention name(s): dental crowns
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cad/cam; dental porcelain; zirconia; press on metal
Role of Instructions in Nitrous Oxide Effects and Choice - 10
Condition: Opioid-Related Disorders; Substance-Related Disorders
MeSH terms: Substance-Related Disorders; Opioid-Related Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to conduct experiments to examine subjective and reinforcing
      effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug
      abusers and preference procedures will be used to assess reinforcing effects. Comparisons
      between nitrous oxide, opiates, and benzodiazepine antagonists will be made. To evaluate the
      role of instructions in nitrous oxide subjective effects and choice.
    


Intervention name(s): Nitrous oxide 10% & placebo; Nitrous oxide 20% & placebo; Nitrous oxide 30% & placebo; Nitrous oxide 40% and placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Nitrous Oxide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: nitrous oxide; instruction; subjective effects; reinforcer; healthy volunteer
The Effect of tDCS Based on Functional Brain Imaging for Subacute Stroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The purpose of this study is to investigate whether brain imaging-based hand function area
      tDCS stimulation is more effective than conventional stimulation or sham stimulation for
      improving hand motor function.
    


Intervention name(s): Transcranial Direct Current Stimulation; Hand motor task
Intervention type(s): Device; Behavioral
Intervention description(s): Transcranial direct current stimulation is a form of noninvasive neuromodulation that uses constant and low direct current delivered via electrodes on the scalp.; Various type of hand motor tasks are applied to stroke patients.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Brentuximab for Newly Diagnosed Hodgkin Disease
Condition: Hodgkin Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The addition of Brentuximab vedotin (Bv) to combination chemotherapy will be safe, well
      tolerated and effective in children, adolescents and young adults with all stages of newly
      diagnosed Hodgkin lymphoma (HL).
    


Intervention name(s): Brentuximab Vedotin; Doxorubicin; Vincristine; Rituximab
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Day 1 and 15 Dose: 1.2 mg/kg/dose. (Maximum dose is 120 mg); Days: 1 and 15 Dose: 25 mg/m2/dose.; Days: 1 and 15 Dose: 1.5 mg/m2/dose (max: 2 mg/dose).; Days: 2 and 16 Dose: 375 mg/m2/dose.
Other intervention name(s): Adcetris; Doxil, Adriamycin; Oncovin; Rituxan
Intervention MeSH terms: Rituximab; Brentuximab Vedotin; Doxorubicin; Vincristine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment