bioihbjkbjnl/mcl2 huggingface dataset:
Analgesics in the Pre-hospital Setting: Implications on Hemorrhage Tolerance - Fentanyl
Condition: Healthy
MeSH terms: Hemorrhage
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this project is to test how fentanyl, an analgesic currently employed in the
      pre-hospital setting by the US Army, alters the capacity to tolerate a hemorrhagic insult in
      humans.
    

Detailed description: 
      Pain management on the battlefield is critical for the wellbeing of the soldier. Given that a
      hemorrhagic injury on the battlefield is virtually always associated with pain, it is
      paramount that the selected pain medication does not disrupt appropriate physiological
      mechanisms that are beneficial towards the maintenance of blood pressure and vital organ
      blood flow during that hemorrhagic insult. Current guidelines for the selection of pain
      medications of a hemorrhaging soldier are based upon limited scientific evidence, with the
      vast majority of supporting studies being conducted on anesthetized animals. Thus, the
      interaction between hemorrhagic shock and pain medications commonly employed on the
      battlefield is yet to be determined in the conscious humans.

      With this background, we will test the hypothesis that fentanyl will impair the capacity for
      a conscious human to tolerate a hemorrhagic insult.

      The obtained data will provide the necessary scientific evidence in humans to support the
      Committee on Tactical Combat Casualty Care (CoTCCC) guidelines on the analgesic of choice for
      moderate to severe injuries where the casualty is in hemorrhagic shock. Notably, such data
      will identify the analgesic that least compromises a human's ability to tolerate a
      hemorrhagic insult, ultimately providing critical information to the combat medic on which
      analgesic should be employed for such an injury.
    

Intervention name(s): Fentanyl; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Subjects will receive 75 ug Fentanyl while the effects of this drug on tolerance to a hemorrhagic insult will be assessed.; Subjects will receive saline while the effects of this drug on tolerance to a hemorrhagic insult will be assessed.
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
A Study to Investigate the Safety and Pharmacokinetics of a Single Dose of VH3810109 (Also Known as GSK3810109), Administered Either Subcutaneously (SC) With rHuPH20 or Intravenously (IV), in Healthy Adult Participants
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      An open-label, two part study to assess the safety, tolerability, and PK of VH3810109 in
      healthy adult participants. Participants will receive a single SC or IV dose of VH3810109
      co-administered with rHuPH20 and will be followed up for 24 weeks.
    


Intervention name(s): VH3810109; rHuPH20
Intervention type(s): Biological; Biological
Intervention description(s): VH3810109 will be administered.; rHuPH20 will be administered.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Participants will receive a single SC or IV dose of VH3810109 co-administered with rHuPH20
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: VH3810109; GSK3810109; HIV; Human Monoclonal Antibody; rHuPH20; Pharmacokinetics; Safety; Tolerability; N6LS
Early Treatment Diabetic Retinopathy Study (ETDRS)
Condition: Blindness; Diabetic Retinopathy
MeSH terms: Blindness; Retinal Diseases; Diabetic Retinopathy
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the effectiveness of both argon laser photocoagulation and aspirin therapy in
      delaying or preventing progression of early diabetic retinopathy to more severe stages of
      visual loss and blindness.

      To help determine the best time to initiate photocoagulation treatment in diabetic
      retinopathy.

      To monitor closely the effects of diabetes mellitus and of photocoagulation on visual
      function.

      To produce natural history data that can be used to identify risk factors and test etiologic
      hypotheses in diabetic retinopathy.
    

Detailed description: 
      ETDRS was a multicenter, randomized clinical trial designed to evaluate argon laser
      photocoagulation and aspirin treatment in the management of patients with nonproliferative or
      early proliferative diabetic retinopathy. A total of 3,711 patients were recruited to be
      followed for a minimum of 4 years to provide long-term information on the risks and benefits
      of the treatments under study.

      The eligibility criteria for the ETDRS were designed to include a broad range of macular
      edema severity, from a few small hard exudates within a disc diameter of the fovea with
      normal visual acuity to extensive cystoid spaces with a visual acuity of 20/200. All study
      patients had one eye randomly assigned to immediate photocoagulation and the other eye to
      deferral of photocoagulation until high-risk proliferative retinopathy developed. During
      followup, additional photocoagulation was allowed for any degree of macular edema within the
      eligibility range, but additional photocoagulation was required only for edema involving or
      threatening the center of the macula. The term "clinically significant macular edema" was
      coined to designate this level of severity.

      The trial use of aspirin therapy was based on clinical observation and on aspirin's possible
      mechanisms of action. Previous observations of diabetic patients who were taking large doses
      of aspirin for rheumatoid arthritis showed that the prevalence of retinopathy in this group
      was lower than the prevalence that would be expected in the diabetic population at large.
      Evidence suggested that diabetic patients have altered platelet aggregation and
      disaggregation, which may contribute to the capillary closure seen in retinopathy. This
      abnormality is reversed by aspirin in vitro . However, because of aspirin's other possible
      mechanisms of action and its well-known side effects, such as allergic, idiosyncratic, and
      intolerance reactions, the use of this therapy in the ETDRS was carefully controlled and
      monitored.
    

Intervention name(s): Aspirin; Argon Laser Photocoagulation
Intervention type(s): Drug; Procedure
Intervention MeSH terms: Aspirin
Allocation: Randomized
Primary purpose: Treatment
Game on Philly: Engaging Underserved Middle School Youth in Out-of- School Time Sports and Nutrition Education
Condition: Exercise; Diet
Study type: Interventional

Summary: 
      Game on Philly is a multi-component out-of-school time intervention delivered by trained
      sport-based youth development coaches and health navigators using evidenced-based
      programming. The program evaluation assesses the impact of this minimal-risk intervention to
      reduce the prevalence of obesity-related health disparities in racial and ethnic minority
      middle school youth. The program is a virtual sport-based youth development program,
      supplemented with nutrition education. The program was modified due to Covid-19 and is
      entirely virtual. Using a quasi-experimental design, six schools are assigned to the
      intervention arm and six schools are assigned to the comparison arm. Participants in
      intervention schools receive access to daily, online after school programming, with live
      sessions with sports providers (via Zoom), weekly team meetings with a health coach (via
      Zoom), text-messages via the Remind app, and the monthly delivery of Activity Kits directly
      to their homes for six months. Comparison school participants receive access to the Game on
      Philly app with workout and sports content and receive one activity kit delivery at the start
      of the program. Parent-child dyads recruited from each school complete surveys at baseline
      and at the end of the 6-month program (follow-up). It is hypothesized that youth
      participating in the intervention will experience significantly greater increases in physical
      activity at the end of the 6-month intervention compared to youth participating in the
      comparison arm (primary outcome). Secondary outcomes will examine changes in dietary intake,
      self-efficacy for physical activity and positive youth development.
    


Intervention name(s): Game on Philly: Engaging Underserved Middle School Youth in Out-of- School Time Sports and Nutrition Education
Intervention type(s): Behavioral
Intervention description(s): Two-group quasi experimental intervention with schools assigned to intervention or comparison.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Two-group quasi-experimental
Masking: Single (Participant)
Primary purpose: Prevention
Safety, Tolerability and Pharmacokinetic Study of ASP1517 in Healthy Non-elderly Male Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the safety and tolerability of ASP1517 after single
      or multiple oral administration in healthy non-elderly adult male subjects.
    

Detailed description: 
      The study consists of two parts, single and multiple dose. Within each part participants will
      be randomized to either ASP1517 or placebo.
    

Intervention name(s): ASP1517; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): FG-4592
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: Pharmacokinetics; Safety and tolerability; Plasma concentration; ASP1517; FG-4592
Cortical Bone Plate Versus Cortico-cancellous Block Graft
Condition: Horizontal Atrophy of Edentulous Alveolar Ridge
MeSH terms: Atrophy
Study type: Interventional

Summary: 
      Horizontal ridge augmentation using either cortical bone plate technique or
      cortico-cancellous block graft was the aim of the study. Bone quality was analyzed
      histomorphomterically, and horizontal dimensional changes were assessed using CBCT.
    


Intervention name(s): Split-block technique; Cortico-cancellous block graft
Intervention type(s): Procedure; Procedure
Intervention description(s): Horizontal ridge augmentation using the split-block technique where a cortical bone plate harvested from the external oblique ridge was split in half and fixed at a distance from the atrophied ridge. Then autogenous bone chips were packed in the gap between the plate and the ridge.; Horizontal ridge augmentation using a cortico-cancellous block harvested from the chin of the mandible.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Split-bone block technique; Cortical bone plate; Cortico-cancellous block graft
Does Diaphragm Electrical Activity Monitoring Predict Extubation Success in Children?
Condition: Diaphragm Electrical Activity; Neurally Adjusted Ventilatory Assist; Pediatrics
Study type: Observational

Summary: 
      This study aimed to record diaphragm electrical activity (Edi) during the preextubation
      (weaning) and postextubation periods and to analyze whether Edi monitoring could predict
      extubation success.
    

Detailed description: 
      This prospective observational study included 25 pediatric patients who were intubated due to
      respiratory failure in the pediatric intensive care unit of the tertiary
      university-affiliated Marmara University Hospital between August 2014 and July 2015. To
      conduct the study, we obtained informed consent from the patient's parents and ethical
      approval from the Marmara University Faculty of Medicine Scientific Research Ethics Committee
      Board on 06.09.2014. Pediatric patients included which had indication for the insertion of a
      nasogastric tube (Edi catheter), independent of the study. So Edi catheter had been used
      instead of nasogastric tube.

      When the patients were ready for clinical weaning in accordance with the clinician, the Edi
      catheter was appropriately inserted into the patients. Then, a spontaneous breathing trial
      (SBT) was performed and diaphragm activity monitoring was recorded during this process. The
      patients who met the inclusion criteria switched in a spontaneous breath trial with pressure
      support ventilation (PSV) or NAVA (Neurally Adjusted Ventilatory Assist) on a Maquet (Solna,
      Sweden) Servo-i mechanical ventilator for both ventilation modes The patients' demographic
      and clinical characteristics, mortality scoring, vital parameters (HR, TA, SpO2, RR) and
      ventilatory parameters (Edi peak, Edi min, FiO2, expiratory Vt), as well as follow-up period
      were recorded. Arterial/capillary blood gases were taken within the last four hours before
      extubation and within the first, sixth, 12th, 18th and 24th hours after extubation. If
      arterial blood gas monitoring was initiated in the patient, arterial monitoring was
      continued. If capillary blood gas monitoring was initiated, capillary monitoring was
      continued. Edi data were recorded for at least 24 hours before and after extubation. Edi
      values were obtained retrospectively from the trend diagram, which provides 24-hour
      continuous records on the ventilator screen.
    

Intervention name(s): Edi catheter
Intervention type(s): Device
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The majority of the patients were under 18 months of age (median 18 months, between 2 and
        204 months) and 60% (n=15) were female.
      
Keywords: pediatrics; extubation success; Diaphragm electrical activity
Impact of Healthy Diet on Metabolic Health in Men and Women
Condition: Healthy Aging; Metabolic Syndrome; Diet, Healthy
MeSH terms: Metabolic Syndrome
Study type: Interventional

Summary: 
      The overall aim of the present research program is to determine how a healthy whole-diet
      approach impacts on cardiometabolic health in adults. With its interdisciplinary approach,
      the study depicts mechanisms behind disease progression and the impact of healthy dietary
      patterns on changes in markers of low-grade systemic inflammation together with the
      exploration of knowledge and attitudes about healthy diets. The study has a preventive
      character as it targets older adults (65+) without manifest disease.
    

Detailed description: 
      This two arm randomized-controlled study includes the following groups: Controls and Healthy
      Diet group.

      The study will particularly address the following aspects:

        -  determine food literacy, perceived attitudes and barriers for the adoption of new
           dietary habits incorporating increased fruit and vegetable intake in adults.

        -  explore the effects of a randomized controlled intervention promoting healthy dietary
           patterns (increased intakes of fruit and vegetable, whole-grain, nuts and low fat dairy
           products and replacing saturated with unsaturated fats and decreased red meat and salt
           consumption) for a period of 4 months on components of the metabolic syndrome, a large
           panel of pro- and anti-inflammatory biomarkers and metabolomic profile in adults.

        -  assess the long-term adherence to healthy dietary patterns in adults.

        -  provide support for behavioural change and evaluate participants' perception of this
           support.
    

Intervention name(s): Healthy Diet
Intervention type(s): Behavioral
Intervention description(s): Receive counseling to meet guidelines for healthy dietary patterns
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Olanzapine Plus Carbamazepine in the Treatment of Bipolar I Mania
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial will assess any efficacious benefit and any safety issues associated with the
      concomitant use of olanzapine and carbamazepine for the treatment of patients with bipolar I
      disorder, manic or mixed episodes
    


Intervention name(s): olanzapine; carbamazepine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Carbamazepine; Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Relative Bioavailability Study of Bupropion Extended-Released 150 mg Tablets Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the rate and extent of absorption of Bupropion HCl
      extended-release tablet (test) to that of Wellbutrin SR extended-release tablet (reference)
      after a single, one-tablet (150 mg) dose in fasted subjects.
    

Detailed description: 
      Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design.

      Official Title: A Randomized, Single Dose Two -Way Crossover Relative Bioavailability Study
      of Bupropion Extended-Released Tablets Formulation in Fasted, Normal, Healthy Subjects.

      Further study details as provided by Actavis Elizabeth LLC:

      Primary Outcome Measures:

      Rate and Extend of Absorption
    

Intervention name(s): Abrika Bupropion 150 mg Extended-Released Tablet; Wellbutrin SR® 150 mg Extended-Release Tablet, single dose
Intervention type(s): Drug; Drug
Intervention description(s): A: Experimental Subjects received Abrika formulated products under fasting conditions; B: Active comparator Subjects received GlaxoSmithKline formulated products under fasting conditions
Other intervention name(s): Bupropion; Bupropion
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Bupropion; Healthy subjects
Anesthetic Efficacy in Irreversible Pulpitis
Condition: Anesthesia
MeSH terms: Pulpitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to compare the anesthetic efficacy of articaine, lidocaine and
      mepivacaine in patients with irreversible pulpitis of mandibular molar.
    

Detailed description: 
      Conventional inferior alveolar nerve block (IANB) is the most commonly used technique for
      achieving pulpal anesthesia in posterior mandibular endodontic procedures. However, IANB has
      a high failure rate and success rates are even lower when applied for the treatment of
      mandibular posterior teeth with irreversible pulpitis.
    

Intervention name(s): Intervention: inferior alveolar nerve block injection
Intervention type(s): Drug
Intervention description(s): -22 patients received inferior alveolar nerve block injections of 3.6 mL (equivalent to 2 cartridges)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: articaine; lidocaine; mepivacaine; inferior alveolar nerve block; irreversible pulpitis
Capecitabine and Pseudomonas Aeruginosa Combination in Metastatic Breast Cancer (MBC)
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The progression free survival could be prolonged adding pseudomonas aeruginosa to monotherapy
      capecitabine.
    

Detailed description: 
      the efficacy of the combination is much better than monotherapy
    

Intervention name(s): capecitabine and pseudomonas aeruginosa combination
Intervention type(s): Drug
Intervention description(s): capecitabine 1000mg/m2 bid, po. pseudomonas aeruginosa 0.5ml loading dose,1ml qod ih.
Other intervention name(s): capecitabine; pseudonomas aeruginosa
Intervention MeSH terms: Capecitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
imPulse™ Una Full-spectrum, Over Clothing E-stethoscope
Condition: Corona Virus Infection; Coronavirus
MeSH terms: Coronavirus Infections
Study type: Observational

Summary: 
      This study generates robust clinical data to train ML/AI algorithms of the Sponsor's imPulse™
      Una full-spectrum e-stethoscope for digital diagnostic feature synthesis of symptomatic
      SARS-CoV-2/COVID-19 biosignatures for rapid and accurate mass screening.
    

Detailed description: 
      This study is designed to evaluate the ability of the imPulse™ Una e-stethoscope to
      differentiate vibroacoustic signals in inpatients with and without confirmed COVID-19 as the
      first step to establish the performance characteristics - sensitivity, specificity, positive
      and negative predictive value - of the imPulse™ Una device for early and rapid, point-of-care
      diagnosis of COVID-19. This will inform the utility and design of further larger-scale
      studies using the device.
    

Intervention name(s): imPulse™ Una e-stethoscope; Philips Lumify Ultrasound System
Intervention type(s): Device; Device
Intervention description(s): The imPulse™ System is an every/anywhere-point-of-care cardiopulmonary functional state assessment platform designed to capture normal and abnormal, audible and inaudible cardiopulmonary sounds, rhythms and patterns, via a real-time, intelligent, full-spectrum phonocardiogram obtained from direct to skin coupling or through a layer of clothing.; Point-of-care ultrasound
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adult men and women will be recruited from among hospitalized patients with symptomatic
        COVID-19 infection who are not receiving ventilator support. One hospitalized control
        without lung disease or pulmonary symptoms will be selected for each case.
      
Keywords: infrasound; e-stethoscope; biosignature; SARS-CoV-2/COVID-19
A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Children Aged 6 Months to 9 Years
Condition: Influenza; Swine-origin A/H1N1 Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic
      vaccine in toddlers and children.

      Primary Objectives:

        -  To describe the immunogenicity of the candidate vaccines after each injection.

        -  To describe the safety of the candidate vaccines after each injection.
    

Detailed description: 
      Participants will receive two injections of their randomized vaccine on Day 0 and Day 21,
      respectively.
    

Intervention name(s): Monovalent Subvirion A/H1N1 Influenza vaccine; Monovalent Subvirion A/H1N1 Influenza vaccine; Normal saline solution (placebo)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on Day 0 and Day 21 (6 months to 35 Months); 0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on day 0 and Day 21 (6 months to 35 Months); 0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on day 0 and Day 21 (6 months to 35 Months)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza; Pandemic Flu; Swine-origin A/H1N1 Influenza; Children