bioihbjkbjnl/mcl2 huggingface dataset:
Thoracolumbar Burst Fractures Study Comparing Surgical Versus Non-surgical Treatment
Condition: Thoracolumbar Burst Fracture
MeSH terms: Fractures, Bone
Study type: Observational

Summary: 
      Thoracolumbar (TL) burst fractures in neurologically intact patients account for
      approximately 45% of all TL spine injuries. Despite being common fractures, there is
      significant variability in treatment recommendations encompassing surgery and non-surgical
      treatment options. The controversy regarding optimal treatment for these injuries is fueled
      by several studies which suggest a potential benefit to surgical treatment in the realm of
      patient satisfaction, and the overall socio-economic burden of treatment while other studies
      demonstrate improved outcomes and lower morbidity with non-surgical treatment. This study
      aims to perform a prospective cohort analysis investigating the clinical outcome of various
      treatment alternatives for patients with A3/A4 fractures in the thoracolumbar region. A
      cost-effectiveness analysis will also be performed to identify costs and benefits of each
      treatment option. More specifically a sub-group analysis will be performed for this group of
      patients, which have equipoise in regards to patients treatment, as decided by a blinded
      review panel.
    

Detailed description: 
      208 subjects (i.e., 137 per surgical group; 71 per conservative group) with TL burst
      fractures AOSpine classification type A3 or A4 without neurological deficit as defined in the
      inclusion/exclusion criteria, and with or without suspected Posterior Ligament Complex (PLC)
      injury (M1) from T10 to L2, will be enrolled in a prospective multicenter cohort study.
      Patients may have an associated B injury, but must have an A3 or A4. Patients will be
      monitored prospectively for patient reported, clinical and radiologic outcomes, over a period
      of 2 years post-treatment. Specifically a patient diary will measure the Oswestry Disability
      Index (ODI), and employment information (indirect costs questionnaire) every second week
      until 6 months post-treatment. Diary will continue every second month until 2 years
      post-treatment. All interventions/examinations are considered as standard of care.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with thoracolumbar burst fractures
      
Keywords: Thoracolumbar spine; Burst fractures; Conservative treatment; Surgical treatment; Thoracic or lumbar vertebrae
Enhanced vs. Routine Clear Liquid Intake in Labor
Condition: Abnormal Labor; Failed Induction of Labor; Ketosis
MeSH terms: Dystocia; Ketosis
Study type: Interventional

Summary: 
      The goal of the study is to see if the addition of a carbohydrate- and protein-enhanced gel
      during labor speeds labor and reduces the rate of cesarean delivery.
    

Detailed description: 
      Patients will be randomized to placebo or experimental arm of study. In the placebo arm,
      patients will receive standard clear liquid diet, which includes ginger ale, variety of fruit
      juices, and plain soup broth. The experimental arm will receive the standard clear liquid
      diet, and in addition will receive Accel Gel every 3 hours while in labor.
    

Intervention name(s): Accel Gel; Usual clear diet
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Accel Gel by PacificHealth Labs in Matawan, NJ.; Usual clear liquids
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Abnormal Labor; Prolonged Induction; Ketosis; Diet
Study on the Safety and Efficacy of Convalescent Plasma in Patients With Severe COVID-19 Disease
Condition: Severe COVID-19 Disease
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      Currently, there is no specific treatment or vaccine for SARS-CoV-2 available, some drugs are
      being investigated as treatment, but the effect is unknown. A strategy and other method used
      before, in coronavirus pandemic (SARS-CoV in 2003 and MERS-CoV in 2012), was the use of
      immune (convalescent) plasma. Passive administration of antibodies through convalescent
      plasma transfusion may offer the only short-term strategy available to confer immediate
      immunity and being a relative immediately resource available for treat COVID-19 disease. This
      research proposes the passive administration of antibodies through the transfusion of
      convalescent plasma, in patients with severe COVID-19 disease.
    

Detailed description: 
      A randomized clinical trial comparing administration convalescent plasma to standard therapy
      for severe COVID-19 disease. Patients will be randomized 1:1 in a single blind study. The
      patients with SARS-CoV-2 PCR confirmed infection with pulmonary infiltrates and hypoxemia
      will be screened and invited to participate. Our primary outcomes will be disease progression
      and mortality, evaluate of ordinal Scale for Clinical Improvement and. (WHO)
    

Intervention name(s): Biological
Intervention type(s): Biological
Intervention description(s): An administration unit of 200 ml convalescent plasma intravenous infusion every 24 hours for two doses.
If a third dose of convalescent plasma is necessary, it may be used, as long as an evaluation of the research team is carried out.
Other intervention name(s): Convalescent plasma
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The PC-COVID-HCM clinical trial is a randomized, controlled, single-blind study .
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SARS-CoV2; Convalescent Plasma; Severe Acute Respiratory Syndrome
A Safety and Efficacy Study of a Topical Gel for the Treatment of Mild to Moderate Psoriasis
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study is to assess the tolerability and efficacy of a 0.10% or
      0.05% PTH (1-34) parathyroid hormone peptide gel in the treatment of mild to moderate plaque
      psoriasis in comparison to treatment with the placebo gel alone.
    

Detailed description: 
      This pilot study aims to confirm the results of a previous proof of concept study performed
      by Dr. Michael Holick using a different dosage form. The secondary objective is to determine
      if there is a dose dependent difference or trend in response between the two concentrations
      of PTH (1-34) peptide gel.

      Subjects will be randomized to receive one of three treatment groups on a 1:1:1 basis. The
      three treatment groups are:

        -  Treatment Group 1: 0.05% PTH (1-34) Gel

        -  Treatment Group 2: 0.10% PTH (1-34) Gel

        -  Treatment Group 3: Placebo Gel
    

Intervention name(s): PTH (1-34) Gel / Placebo Gel
Intervention type(s): Drug
Intervention description(s): Topical dosing of gel twice daily for eight weeks.
Intervention MeSH terms: Parathyroid Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Plaque psoriasis; Psoriasis
LOC387715/HTRA1 and the Combined Photodynamic Therapy With Intravitreal Bevacizumab in Polypoidal Choroidal Vasculopathy
Condition: Age-Related Macular Degeneration
MeSH terms: Macular Degeneration; Polypoidal Choroidal Vasculopathy
Study type: Observational

Summary: 
      This study is to investigate whether there is an association of the LOC387715/HTRA1 variants
      with response to treatment with combined photodynamic therapy and intravitreal bevacizumab
      for patients with polypoidal choroidal vasculopathy.
    

Detailed description: 
      This is a retrospective cohort study comprised of 70 eyes being treated for polypoidal
      choroidal vasculopathy with combined photodynamic therapy and intravitreal bevacizumab
      injections. Patients were genotyped for the LOC387715 (rs10490924) and the HTRA1 gene
      polymorphism (rs11200638).
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The authors did a retrospective chart review of 70 patients with PCV who were treated at
        the Department of Ophthalmology, Kyungpook National University Hospital in Daegu, Korea.
      
Biospecimen description: 
      Genomic DNA was extracted from peripheral blood. The two SNPs (rs10490924 in the LOC387715
      locus and rs11200638 in HTRA1 gene) were analyzed by LC480 Real time PCR (Roche, Basel,
      Switzerland) at D&P Biotech (Daegu, Korea).
Multi-center Observational Study to Evaluate Epidemiology and Resistance Patterns of Common ICU-Infections (MOSER)
Condition: Nosocomial Infections
MeSH terms: Infections; Communicable Diseases; Cross Infection
Study type: Observational

Summary: 
      Most literature on ICU infections and the resistant patterns comes from the western
      literature. This data may not truly reflect the incidence, epidemiology and resistance
      patterns in developing countries such as India. However, empiric antibiotic therapy is
      generally initiated using western guidelines. This can potentially lead to inadequate,
      inappropriate and ineffective empiric antibiotic therapy for ICU infections in the Indian
      setting. Hence in this multi-center observational study, we seek to:

        1. To determine the incidence of ICU-related infections (VAP, CAUTI and CRBSI) in India

        2. To explore the microbiology, resistance and treatment patterns of these infections
    


Intervention name(s): No intervention
Intervention type(s): Other
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult ICU patients
      
Keywords: Ventilator associated pneumonia; Catheter related blood stream infection; Catheter associated urinary tract infection; ICU-related infections (VAP, CAUTI and CRBSI); India
Oxcarbazepine Versus Placebo in Childhood Autism
Condition: Autism
MeSH terms: Autistic Disorder
Study type: Interventional

Summary: 
      The proposed study is designed to assess the effectiveness of treatment with Oxcarbazepine
      vs. placebo in childhood/adolescent autism. This is a twelve-week study involving twenty
      subjects between the ages of five and seventeen with a diagnosis of autism.
    

Detailed description: 
      The proposed study is designed to assess the effectiveness of treatment with Oxcarbazepine
      vs. placebo in childhood/adolescent autism. This is a twelve-week study involving twenty
      subjects between the ages of five and seventeen with a diagnosis of autism. Subjects will
      receive a psychiatric and medical evaluation by the study psychiatrist to see if she/he has
      any psychiatric or medical illnesses that would interfere with their ability to participate
      in this study. These evaluations may take up to an hour to complete. In addition, subjects
      will be asked to participate in a psychiatric interview designed to determine the child's
      diagnosis and current problem areas. The subject's parent will also be asked to fill out
      psychiatric questionnaires. The interview and questionnaires may take up to 4 hours to
      complete.
    

Intervention name(s): Oxcarbazepine; Placebo/sugar pill
Intervention type(s): Drug; Other
Intervention description(s): Oxcarbazepine is available in a 300mg/5ml solution. Dosage will start at 150 mg (2.5ml) at night for 3 days and will be increased to 150 mg in the am and pm. For children who are able to tolerate the 150 mg BID dose, the oxcarbazepine will be increased to 300 mg at night and 150 mg in the morning for 3 days and 300 mg BID for the next week. The children will remain on this dose until week 3, at which time if they are tolerating the medication and do not have a Clinical Global Improvement Scale (CGI) of 1 (very much improved) they will be increased to 600 mg twice a day in a method similar to the above increases. After week 4, the child will remain on the same stable dose.; Dosage similar to active drug
Other intervention name(s): Trileptal
Intervention MeSH terms: Oxcarbazepine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Irritability; Functional Ability; Aggression; Mood Instability
Effect of Panitumumab on the Pharmacokinetics of Irinotecan
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to determine if panitumumab affects the
      pharmacokinetic (PK) profile of irinotecan.
    


Intervention name(s): Panitumumab; Irinotecan
Intervention type(s): Drug; Drug
Intervention description(s): The first infusion of panitumumab will occur on Cycle 1 Day 4. On Cycle 2 Day 1, panitumumab will be administered on the same day as irinotecan and every 2 weeks thereafter.; The first infusion of irinotecan will occur on Cycle 1 Day 1. Irinotecan will be administered on the same day as panitumumab on Cycle 2 Day 1 and every 2 weeks thereafter.
Other intervention name(s): Vectibix; Camptosar
Intervention MeSH terms: Irinotecan; Panitumumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: colorectal cancer; chemotherapy; cancer; metastatic; irinotecan; EGFr; epidermal growth factor
Effect of Therapeutic and Supratherapeutic Oral Doses of GSK3640254 on Cardiac Conduction Compared to Placebo and a Single Oral Dose of Moxifloxacin
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will aim to evaluate the effect of therapeutic and supratherapeutic oral doses of
      GSK3640254 on cardiac conduction compared to placebo and a single oral dose of Moxifloxacin
      in healthy adult participants. The study has 2 parts: Part 1 will determine the
      supratherapeutic dose for Part 2, which will be the main corrected QT interval (QTc) study.
      Part 1 will evaluate once daily (QD) dosing of GSK3640254 or placebo and Part 2 will
      investigate the safety, tolerability and Pharmacokinetics (PK) of GSK3640254 doses on cardiac
      conduction as compared to placebo and a single oral dose of Moxifloxacin in healthy adult
      participants. Moxifloxacin will be included as a positive control.
    


Intervention name(s): GSK3640254; Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GSK3640254 will be administered.; Placebo will be administered.; Moxifloxacin will be administered.
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: GSK3640254; Moxifloxacin; Electrocardiogram; Cardiac Conduction; Supratherapeutic dose
A Pharmacokinetic Study to Investigate the Effect of Food on the Pharmacokinetics of YM150
Condition: Healthy; Pharmacokinetics of YM150
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to evaluate the effect of food on the pharmacokinetics of YM150 in healthy male
      adult subjects.
    

Detailed description: 
      To evaluate the effect of food on the pharmacokinetics of YM150 in healthy non-elderly adult
      male subjects using a 2×2 crossover design. Also, to evaluate the safety of YM150.
    

Intervention name(s): YM150
Intervention type(s): Drug
Intervention description(s): oral
Intervention MeSH terms: Darexaban
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: YM150; Food effect; Healthy volunteer
Effect of Antioxidant Docosahexaenoic Acid (DHA) in Cystic Fibrosis Patients
Condition: Cystic Fibrosis in Children
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      This study evaluates the effect of antioxidant docosahexaenoic acid (DHA) in patients with
      cystic fibrosis. Half of participants will receive DHA, while the other half will receive
      placebo.
    

Detailed description: 
      Several studies show that patients with cystic fibrosis (CF) usually have, compared to the
      normal population, low levels of linoleic acid (LA) and docosahexaenoic acid (DHA) and
      increase in arachidonic acid (AA), which is pro-inflammatory. Normalization or modification
      of this fatty acid pattern (AP) could reduce chronic inflammation. The aim of this study is
      to assess the effect of oral supplementation with DHA for one year in pediatric patients
      (6-18 years) with CF, on inflammatory parameters, AP profile, lung function (spirometry) and
      number of exacerbations.
    

Intervention name(s): ANTIOXIDANT DHA TRIGLYCERIDE (TRIDOCOSAHEXAENOINE-AOX®); PLACEBO (OLIVE OIL)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Pearls of DHA (BrudyNen); Pearls manufactured to mimic DHA (BrudyNen).
Intervention MeSH terms: Antioxidants
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Is not a drug, is a food supplement.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: cystic fibrosis; Docosahexaenoic Acid; fatty acids
Impact of Cardiac Magnetic Resonance Imaging on Endothelial Function in Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Magnetic resonance (MR) imaging is a widely used and well-established noninvasive medical
      diagnostic imaging tool. By using a static and a gradient magnetic field in combination with
      a radiofrequency field (RF), MR provides excellent contrast among different tissues of the
      body. Although long-term effects on human health from exposure to strong static magnetic
      fields seem unlikely, acute effects such as vertigo, nausea, change in blood pressure,
      reversible arrhythmia, and neurobehavioural effects have been documented from occupational
      exposition to 1.5 T. Cardiac MR (CMR) imaging requires some of the strongest and fastest
      switching electromagnetic gradients available in MR exposing the patients to the highest
      administered energy levels accepted by the controlling authorities. Studies focusing on
      experimental teratogenic or carcinogenic effects of MR revealed conflicting results. Since
      CMR is emerging as one of the fastest growing new fields of broad MR application, it is of
      particular concern that a recent in vitro study with CMR sequences has reported on
      CMR-induced DNA damages in white blood cells up to 24 h after exposure to 1.5 T CMR.
      Therefore, we hypothesized that CMR can induce the damage of endothelium and endothelial
      progenitor cells in type 2 diabetes
    


Intervention name(s): CMR
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
A Safety and Feasibility Study of the FARAPULSE Endocardial Ablation System to Treat Paroxysmal Atrial Fibrillation
Condition: Paroxysmal Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      PEFCAT is a prospective, single-arm, multi-center, safety and feasibility study evaluating
      the FARAPULSE Endocardial Ablation System for the treatment of paroxysmal atrial
      fibrillation.
    

Detailed description: 
      Patients undergoing catheter ablation for paroxysmal atrial fibrillation will be screened for
      enrollment per protocol inclusion and exclusion criteria. Enrolled patients will then undergo
      ablation using the FARAPULSE Endocardial Ablation System. Subjects will be followed at 7
      days, 30 days, 75 days, 6 months, and 12 months with a blanking period for recurrent atrial
      fibrillation or atrial tachycardia of 3 months following the PEF (pulsed electric field)
      catheter ablation procedure.
    

Intervention name(s): FARAPULSE Endocardial Ablation System
Intervention type(s): Device
Intervention description(s): Endocardial ablation using the FARAPULSE Endocardial Ablation System.
Intervention model: Single Group Assignment
Intervention model description: Patients undergoing catheter ablation of paroxysmal atrial fibrillation and meeting all protocol inclusion/exclusion criteria will be treated with the FARAPULSE Endocardial Ablation System.
Masking: None (Open Label)
Primary purpose: Treatment
A Study of the Safety and Efficacy of Rituximab in Patients With Moderate to Severe Rheumatoid Arthritis Receiving Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This was a Phase II, randomized, double-blind, multicenter study designed to evaluate the
      safety and efficacy of rituximab, administered at two different regimens for 2 years, in
      patients with moderate to severe active rheumatoid arthritis (RA) receiving stable doses of
      methotrexate (MTX).
    


Intervention name(s): folate; methotrexate; methylprednisolone; Placebo; Rituximab
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Minimum of 1 mg/day oral (or folinic acid 5 mg/week); 15-25 mg/week oral or parenteral (10-14 mg/week if intolerant); 100 mg intravenous (IV) prior to each rituximab infusion (For Arm B, for the Months 6 and 18 cycles, IV saline was administered prior to each placebo infusion); To maintain the blind, patients in Arm B (Rituximab 1000 mg) received placebo infusions at Months 6 and 18.; 500 mg or 1000 mg IV*2.
Intervention MeSH terms: Methylprednisolone; Rituximab; Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Rituxan; RA