bioihbjkbjnl/mcl2 huggingface dataset:
A Safety and Efficacy Study for Epoetin Alfa in Pre-dialysis Subjects.
Condition: Anemia; Kidney Failure; Left Ventricular Hypertrophy
MeSH terms: Renal Insufficiency; Hypertrophy, Left Ventricular; Hypertrophy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if using Eprex, to maintain hemoglobin within the
      normal range, will prevent or delay the progression of left ventricular mass growth.
    

Detailed description: 
      Cardiovascular disease continues to be the major cause of morbidity and mortality in subjects
      with renal (kidney) disease. Left ventricular hypertrophy (LVH) has been correlated with a
      high risk of cardiac and all cause mortality. In the renal population , many factors have
      been shown to be important in the development of LVH, including anemia. This is a
      multicentre, open, controlled, randomized trial to determine if maintaining hemoglobin within
      the normal range delays the progress of left ventricular mass growth. Additionally, this
      study will evaluated the safety of maintaining hemoglobin within the normal range in
      pre-dialysis subjects. The trial duration is 24 months. Subjects randomized to the treatment
      arm will receive Eprex therapy to maintain hemoglobin between 120-140 g/L. Subjects
      randomized to the control arm will not receive any treatment unless their hemoglobin falls to
      less than or equal to 90 g/L. Those subjects will then be treated to maintain their
      hemoglobin between 90-105 g/L. The subjects were to receive injections of Eprex once weekly
      to maintain hemoglobin levels within the target range for the arm to which they were
      randomized. The subjects were to receive treatment for up to 24 months.
    

Intervention name(s): epoetin alfa
Intervention type(s): Drug
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Anemia; epoetin alfa
Ventilation Distribution During Spontaneous Breathing in Healthy Newborn Infants
Condition: Spontaneous Breathing; Full-Term Neonate
MeSH terms: Respiratory Aspiration
Study type: Observational

Summary: 
      Electrical impedance tomography (EIT) is an evolving monitoring tool for respiratory support
      in neonatal and pediatric intensive care. In this observational study basic EIT parameters
      will be measured on 20 healthy newborn infants during spontaneous breathing and assess the
      effect of position changes in ventilation distribution.
    

Detailed description: 
      NEO SensorBelts will be used to observe ventilation distribution in healthy newborn infants
      during quiet spontaneous breathing. Child's position will be changed 5 times every 10 minutes
      in a random order. Positions observed will be: left lateral, right lateral, supine, prone
      face to left, prone face to right and supine with the bed tilted 30 degrees. Total duration
      for the recording will be 1 hour.
    

Intervention name(s): Swisstom BB2 EIT device
Intervention type(s): Device
Intervention description(s): Swisstom BB2 EIT device with NEO SensorBelts will be used to measure ventilation distribution during spontaneous breathing and position changes in healthy newborn infants.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        20 healthy full-term infants
The Safety and Efficacy of an Antibiotic Sponge in Diabetic Patients With Moderately Infected Foot Ulcers
Condition: Diabetic Foot Ulcer
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether the gentamicin-collagen sponge when
      combined with standard daily wound care and an oral antibiotic (levofloxacin) is safe and
      effective in treating moderately infected skin ulcers compared to treatment only with
      standard daily wound care and an oral antibiotic (levofloxacin).
    

Detailed description: 
      Infected skin ulcers with diabetes can be very debilitating because they are difficult to
      heal. Diabetic ulcers are responsible for frequent health care visits, and are a major
      predictor of amputation. Diabetic ulcers can be caused by a patient's inability to sense pain
      or warmth as well as peripheral vascular disease, which causes diminished blood flow to the
      foot. Early aggressive treatment is necessary to treat infection and ultimately prevent the
      need for amputation.

      Gentamicin is an antibiotic that is effective in treating certain kinds of infection.
      Collagen is a protein that is found in all mammals. The gentamicin-collagen sponge is a thin
      flat sponge made out of collagen that comes from cow tendons and containing gentamicin. When
      applied to an open ulcer, the collagen breaks down and the gentamicin is released into the
      ulcer, but very little is absorbed into the blood stream. The high levels of gentamicin in
      the open infected ulcer may help treat the infection.

      In this study, all subjects will be given the necessary supplies and taught how to take care
      their foot ulcer. All subjects will also receive oral an antibiotic (levofloxacin).
      Additionally, subjects who are randomly assigned to receive the gentamicin-collagen sponge
      will place a gentamicin-collagen sponge on their ulcer during daily wound care.
    

Intervention name(s): gentamicin-collagen sponge and levofloxacin; Levofloxacin only
Intervention type(s): Drug; Drug
Intervention description(s): Topical Gentamicin Collagen Sponge: 10 × 10 cm in size And 750 mg tablet po every 24 hours or 750 mg IV administered by slow infusion over 90 minutes every 24 hours.; levofloxacin, 750 mg tablet po every 24 hours or 750 mg IV administered by slow infusion over 90 minutes every 24 hours
Other intervention name(s): Collatamp G; Tavanic, Levaquin
Intervention MeSH terms: Levofloxacin; Ofloxacin; Gentamicins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; ulcers; ulcerations; infection
Study to Assess the Effect of BMS-791325 on the Pharmacokinetics of Midazolam in Healthy Subjects
Condition: Hepatitis C
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of BMS-791325 on the pharmacokinetics of
      the CYP3A4 Probe Midazolam.
    


Intervention name(s): Midazolam; BMS-791325
Intervention type(s): Drug; Drug
Intervention description(s): Syrup, Oral, 5 mg, Single dose, 2 days; Capsules, Oral, 300 mg, Every 12 hours, 8 days
Intervention MeSH terms: Midazolam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Human Volunteers
Phytoserms for Menopause Symptoms and Age-Associated Memory Decline
Condition: Hot Flashes; Memory Loss
MeSH terms: Memory Disorders; Hot Flashes
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of a soy based dietary
      supplement (phytoSERM) for hot flashes and age associated memory loss.
    


Intervention name(s): PhytoSERM tablet; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Inhaled Milrinone in Cardiac Surgery
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the concentration-effect relationship of inhaled
      milrinone after prophylactic administration in cardiac surgical patients with preoperative
      pulmonary hypertension undergoing cardiopulmonary bypass.
    

Detailed description: 
      Milrinone elimination will be verify with blood and urine samples analysis.
    

Intervention name(s): Inhaled milrinone 5 mg
Intervention type(s): Drug
Intervention description(s): Inhaled milrinone 5 mg (as for the injectable solution)
Other intervention name(s): Primacor
Intervention MeSH terms: Milrinone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pulmonary hypertension; Cardiac surgery; Cardiopulmonary Bypass (CPB)
Novel MRI Sequence MR Fingerprinting in Breast MRI Feasibility Study
Condition: Breast Screening
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate potential clinical efficacy of a novel magnetic
      resonance imaging (MRI) approach, MR fingerprinting, capable of providing quantitative
      measures of important tissue properties, which could provide important insights into normal
      breast tissue. This new MRI sequence will be added to the screening breast Dynamic Contrast
      Enhanced (DCE) MRI for high risk normal patients.
    

Detailed description: 
      This is a feasibility study of the use of the additional MR fingerprinting (MRF) scanning
      sequence with a total of 12 minutes scanning time to our clinical screening breast DCE MRI
      examination before contrast medium injection and at the end of scan. This additional scanning
      sequence may provide faster and better quantitative tissue characterization comparing to
      conventional MR sequences. There is no investigational contrast agent in this study. We
      propose that the additional MRF sequence may provide faster and more accurate tissue
      characteristics imaging for clinical evaluation of breast tissue. Patients will be enrolled
      in with scheduled high risk screening DCE MRI (n=30). The MR imaging will be performed in the
      clinical 1.5T MR scanners in UNC as normally done for the patients MRI schedule. We only add
      an additional MRF sequence within the MRI exam just prior to the contrast enhancement scan.

      Quantitative measurement of the breast tissue will be performed after the MR exam. The
      region-of-interest (ROI) of normal breast parenchyma was recorded. The ROI will be saved and
      encoded to the T1 map, T2 map in MRF, T1 weighted imaging, T2 weighted imaging. A large
      variety of imaging ROI-based quantitative measures will be calculated among normal glands in
      bilateral breasts to evaluate different ROI characteristics among different patients and
      between bilateral breasts in each patient.
    

Intervention name(s): MR Fingerprinting
Intervention type(s): Device
Intervention description(s): The MR fingerprinting technique requires less than 15 minutes total and will be added before and after the standard MRI sequence.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Biodiesel Exhaust, Acute Vascular and Endothelial Responses
Condition: Healthy
Study type: Interventional

Summary: 
      Exposure to particulate air pollution has been shown to increase cardiovascular mortality and
      morbidity, and in previous controlled exposure studies has been shown to have acute
      cardiovascular and respiratory effects. The last decade has seen an unprecedented drive
      towards finding a bioeconomical and renewable source of fuel in order to reduce our
      dependence on fossil fuels. Although both biodiesel and bioethanol have emerged as contenders
      for future fuels, biodiesel remains as the strongest contender within European markets. In
      2007 researchers at the EPA released a commentary, which concluded that the assumed
      correlation between the chemical composition of biodiesel exhaust and a reduction in health
      effects was only hypothetical. They suggested that there was a clear need for the study of
      health effects in humans regarding biofuel exhaust. In this project the investigators aim to
      investigate the cardiovascular, respiratory and inflammatory responses to biofuel exhaust
      exposure in healthy volunteers.
    


Intervention name(s): Forearm venous occlusion plethysmography study
Intervention type(s): Other
Intervention description(s): Forearm venous occlusion plethysmography to measure forearm blood flow during unilateral intrabrachial infusion of endothelium-dependent (bradykinin [100, 300 & 1000 pmol/min]; acetylcholine [5, 10 & 20 µg/min]) and -independent [sodium nitroprusside [2, 4 & 8 µg/min]; verapamil [10, 30 & 100 µg/min]) vasodilators. Each drug to be infused for 6 mins at each dose in increasing concentrations. 0.9% sodium chloride will be infused for 20 min between each individual drug to allow washout.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Air Pollution; Diesel exhaust; Biodiesel exhaust; Vascular function; Fibrinolysis; Acute vascular and endothelial responses
Osteopathy in Chronic Obstructive Pulmonary Disease (COPD) Rehabilitation Trial
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this trial is to verify if an osteopathic treatment added to usual pulmonary
      rehabilitation trial is able to improve the walking ability of COPD patients and if there is
      any influence on lung functionality.
    

Detailed description: 
      The investigators decided to perform an osteopathic manipulative treatment (OMT) in a
      population of COPD patients. OMT was defined as the therapeutic application of manually
      guided forces by an osteopathic practitioner to improve physiologic function and/or support
      homeostasis that has been altered by somatic dysfunction. Concerning the respiratory system,
      osteopathy considers a model that describes the interdependent functions among five body
      components as follows: 1: the inherent motility of the brain and spinal cord; 2: fluctuation
      of the cerebrospinal fluid; 3: mobility of the intracranial and intraspinal membranes; 4:
      articular mobility of the cranial bones; 5: the involuntary mobility of the sacrum between
      the ilia. This model is the so called primary respiratory mechanism.
    

Intervention name(s): Active osteopathic treatment (OMT+PR): Active Comparator; sham osteopathic treatment (SOT+PR)
Intervention type(s): Other; Other
Intervention description(s): The treatment was done once a week for 4 weeks and lasted 30 minutes.The examination was done according to the following scheme: anamnesis; physical examination (evaluation of the posture, palpation, tests for passive and active motion of areas linked to altered respiratory function); cranic-sacral evaluation (by means of a palpation of the cranic-sacral mechanism).; Only soft manipulation was performed
Other intervention name(s): OMT+PR; SOT+PR
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: COPD
Study Comparing a 13-valent Pneumococcal Conjugate Vaccine With 23-valent Pneumococcal Polysaccharide Vaccine in Adults
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess the safety, tolerability and immune response of 13-valent pneumococcal
      conjugate vaccine (13vPnC) compared with 23-valent Pneumococcal Polysaccharide Vaccine
      (23vPS). Although the study started with only 1 population, amendments to the original
      protocol will now reflect three participant populations. Three age cohorts will be enrolled.
      The first cohort (age 60-64) will be blinded. Cohort 2 (age 50-59) and cohort 3 (age 18-49)
      are open label. Subjects in cohorts 1 and 2 will receive 2 vaccinations 3-4 years apart.
      Subjects in cohort 3 will receive 1 vaccination. All participants should be naïve of 23vPS.
      Comparisons of immune responses from the different cohorts will be done.
    


Intervention name(s): 13-valent pneumococcal conjugate vaccine (13vPnC); 23-valent Pneumococcal Polysaccharide Vaccine (23vPS); 13-valent pneumococcal conjugate vaccine (13vPnC); 13-valent pneumococcal conjugate vaccine (13vPnC); 13-valent pneumococcal conjugate vaccine (13vPnC); 23-valent Pneumococcal Polysaccharide Vaccine (23vPS); 13-valent pneumococcal conjugate vaccine (13vPnC)
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): 0.5 mL dose administered on day 1; 0.5 mL dose administered on day 1; 0.5 mL dose administered on day 1; 0.5 mL dose administered on day 1; 0.5 mL dose administered 3-4 years after dose 1; 0.5 mL dose administered 3-4 years after dose 1; 0.5 mL dose administered 3-4 years after dose 1
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vaccine; Pneumococcal Infections Prevention and Control
Local Host Modulating Agents Alendronate & Aloe Vera for Treatment of Furcation Defects in Chronic Periodontitis
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis; Furcation Defects
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Alendronate (ALN), commonly use bisphosphonates is proposed to have osteostimulative
      properties in vivo and in vitro, as shown by an increase in the matrix formation, and acts as
      a potent inhibitor of bone resorption. AV widely known for its wound healing, analgesic,
      antioxidant, antibacterial, antiviral, antifungal, immune boosting and significant
      anti-inflammatory properties. The present study aims to explore the efficacy of 1% ALN and AV
      gel as a local drug delivery as an adjunct to scaling and root planing (SRP) for the
      treatment of degree II furcation defects
    

Detailed description: 
      Alendronate (ALN), commonly use bisphosphonates is proposed to have osteostimulative
      properties in vivo and in vitro, as shown by an increase in the matrix formation, and acts as
      a potent inhibitor of bone resorption. AV widely known for its wound healing, analgesic,
      antioxidant, antibacterial, antiviral, antifungal, immune boosting and significant
      anti-inflammatory properties. The present study aims to explore the efficacy of 1% ALN and AV
      gel as a local drug delivery as an adjunct to scaling and root planing (SRP) for the
      treatment of degree II furcation defects.

      Methods: Ninety patients with mandibular buccal class II furcation defects were randomly
      allocated into three treatment groups: SRP plus placebo gel (group 1), SRP plus 1% ALN gel
      (group 2) and SRP plus AV gel (group3). Clinical and radiographic parameters were recorded at
      baseline and gel were delivered at respective site. Then again all clinical and radiographic
      parameters were recorded after 6 and 12 months from baseline.
    

Intervention name(s): placebo; Alendronate; Aloe Vera
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral prophylaxis followed by placement of placebo gel; Oral prophylaxis followed by placement of Alendronate gel; Oral prophylaxis followed by placement of Aloe Vera gel
Other intervention name(s): inactive drug; ALN; AV
Intervention MeSH terms: Alendronate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Positron Emission Tomography (PET) Study of Brain Calcitonin Gene-Related Peptide (CGRP) Receptor Occupancy After Telcagepant Administration (MK-0974-067)
Condition: Migraine
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the receptor occupancy (RO) associated with
      telcagepant (MK-0974) administration based on displacement of [11C]MK-4232 from the CGRP
      receptors in the brain using PET. The study enrolled healthy participants (Part I) and
      migraine patients (Part III). Due to a protocol amendment, study Part II was not conducted.
    

Detailed description: 
      For the 1120 mg (i.e., maximal) telcagepant dose, [11C]MK-4232 was administered and PET scan
      was started ~3 hours post telcagepant to coincide with the Tmax of the 1120 mg dose. For the
      140 mg (i.e., therapeutic) telcagepant dose, [11C]MK-4232 was administered and PET scan was
      started ~2 hours post telcagepant to correspond with the timing of clinical efficacy
      measurements of telcagepant for migraine treatment in Phase III studies.
    

Intervention name(s): telcagepant; [11C]MK-4232
Intervention type(s): Drug; Drug
Intervention description(s): Single oral doses of telcagepant 1120 mg (Part I - Period 1) and 140 mg (Part I - Period 2; Part III - Period 1 and 2); Single intravenous doses of ~300 MBq [11C]MK-4232 administered as a 5 minute infusion (Part I - Baseline, Period 1 and 2; Part III - Period 1 Baseline and Period 1, and Period 2 Baseline and Period 2)
Other intervention name(s): MK-0974
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults for COVID-19
Condition: Severe Acute Respiratory Syndrome; Coronavirus; SARS-CoV-2; COVID-19
MeSH terms: COVID-19; Severe Acute Respiratory Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to evaluate the safety and reactogenicity profile after 1 and 2 dose
      administrations of CVnCoV at different dose levels.
    

Detailed description: 
      Funded by Coalition for Epidemic Preparedness Innovations (CEPI).

      This clinical trial information was submitted voluntarily under the applicable law and,
      therefore, certain submission deadlines may not apply. (That is, clinical trial information
      for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public
      Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by
      sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
    

Intervention name(s): CVnCoV Vaccine; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): Participants will receive an intramuscular injection by needle in the deltoid area.; Participants will receive an intramuscular injection by needle in the deltoid area.
Other intervention name(s): CV07050101
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Safety; Reactogenicity; Immunogenicity; Vaccine; CEPI