bioihbjkbjnl/mcl2 huggingface dataset:
Assessment of LBR-101 In Chronic Migraine
Condition: Chronic Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine whether monthly subcutaneous administration of
      LBR-101 (fremanezumab) is safe and provides migraine prevention in patients with chronic
      migraine.
    

Detailed description: 
      Two distinct doses of subcutaneous LBR-101 (fremanezumab) administered monthly will be
      compared to placebo for safety and efficacy. The mean change from baseline in the number of
      cumulative headache hours measured at the 28-day period ending with week 12.
    

Intervention name(s): LBR-101 High Dose; LBR-101 Low Dose; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subcutaneously Administered LBR-101 Monthly x 3; Subcutaneously Administered LBR-101 Monthly x 3; Subcutaneously Administered Placebo (Vehicle) Monthly x 3
Other intervention name(s): Fremanezumab; Fremanezumab
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Headache; Migraine; Chronic Migraine
A Multiple-Dose Study to Assess the Safety, Tolerability, and Steady State Pharmacokinetics of APD791 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The APD791-002 study is designed primarily to evaluate the safety, tolerability, and
      pharmacokinetics of APD791 when administered for 7 days to healthy adult subjects.
    


Intervention name(s): APD791
Intervention type(s): Drug
Intervention description(s): APD791 or matching placebo in escalating doses
Intervention MeSH terms: APD791
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy adult volunteers
Study Measuring Total Plasma Ropivacaine Levels During Continuous Peripheral Nerve Catheter Infusion
Condition: Anesthesia
Study type: Observational

Summary: 
      The purpose of the study is to measure the blood levels of the medicine called ropivacaine
      (local anesthetic) used to manage pain. Ropivacaine is a widely used medication and is not
      the subject of this study, but the investigators are studying how much of the drug can be
      found in the patient's blood, known as the blood level, of this medicine. Too much
      ropivacaine in a patient's blood can lead to local anesthetic toxicity. Once the nerve
      catheter is removed, local anesthetic toxicity is no longer a potential problem. However,
      there is little data on what ropivacaine blood levels are after having the catheter in for a
      long period of time(up to one month).
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Military health care beneficiaries age 18 years and older presenting for upper or lower
        extremity surgery requiring continuous infusions of local anesthetic either at WRNMMC will
        be asked to participate in the study. We will recruit up to fifty patients for the study at
        WRNMMC.
      
Biospecimen description: 
      The plasma ropivacaine samples will be assayed at the Department of Research Programs
      Laboratory (DRP) at WRNMMC. Once the whole blood sample has been centrifuged, the plasma will
      be removed with a glass pipette, placed in a storage container. The blood samples will be
      labeled with a non sequential serial number and will not include the time of the blood draw.
      This will blind the DRP laboratory to the patient's identity and timing of the blood draw.
    
Keywords: Ropivacaine Level; continuous peripheral nerve blocks.
A Bioequivalence Study Comparing Two Different Strengths Formulations of Insulin Lispro in Patients With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To demonstrate bioequivalence between insulin lispro given as SAR342434, 200 Units/ml test
      formulation (T) and insulin lispro 100 Units/ml reference formulation (R) after a single
      subcutaneous (SC) dose

      Secondary Objectives:

        -  To assess the pharmacodynamic profiles and further pharmacokinetic characteristics of
           the test formulation (T) in comparison to the reference formulation (R) after a single
           SC dose

        -  To assess the safety and tolerability of the test and the reference formulation of
           insulin lispro
    

Detailed description: 
      Study duration per participant is approximately 62 days including a screening period up to 28
      days before first dose, 2 periods of 2 days, a wash out period of 5 to 18 days (preferred7
      days) and an end of study visit 7 to 14 days after the last dose
    

Intervention name(s): Insulin Lispro SAR342434; Insulin Lispro SAR342434
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form:solution for injection Route of administration: subcutaneous; Pharmaceutical form:solution for injection Route of administration: subcutaneous
Other intervention name(s): Insulin lispro Sanofi®
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Prospective Study of Fibrosis In the Lung Endpoints (PROFILE - Central England)
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Observational

Summary: 
      The overall aim of this study is to develop a test that predicts the prognosis of IPF
      (Idiopathic Pulmonary Fibrosis) and which could be used to determine whether new treatments
      for IPF are likely to work.
    

Detailed description: 
      The overall objectives of this study are

        -  Discover and validate novel biomarkers and gene expression profiles for use in
           subsequent intervention studies in patients with IPF

        -  To prospectively validate a panel of previously published biomarkers in patients with
           well characterized idiopathic fibrosing lung disease

        -  Investigate genetic associations and epigenetic modifications which affect disease
           severity and progression

        -  Prospectively evaluate longitudinal disease behaviour in patients with IPF and NSIP with
           a view to developing composite clinical end-points for subsequent use in intervention
           studies in patients with IPF

      Biomarkers that can be used for the following purposes will be identified:

        -  Identify patients (Diagnostic)(e.g. discriminate between health and disease)

        -  Correlate with disease severity (extent of disease, staging of disease)

        -  Predict clinical progression (Prognostic)(stable vs progressive disease)

        -  Track response to therapy (Therapeutic response)- Predict response to known efficacious
           treatments & Correlates with changes in clinical endpoints/mortality/quality of life

        -  Predict risk of exacerbations (could be used to prevent exacerbations or reduce their
           severity)

        -  Correlate with complications and/or comorbidities (e.g. biomarkers of Pulmonary Arterial
           Hypertension, Gastro Oesophageal Reflux in IPF, etc)
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Participants will be recruited from IPF clinics
      
Biospecimen description: 
      Blood(serum, plasma) & Lavage Fluid
    
Keywords: Idiopathic Pulmonary Fibrosis; IPF; Lung Fibrosis; Biomarkers
Implantable Antenna Sensors for Continuous Glucose Monitoring
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      The researchers' long-term goal is to develop a small implantable device that can continually
      monitor glucose levels. This will be an antenna. Changes in the glucose levels in will affect
      the antenna signals and those can be used to predict the patient's glucose levels.
    

Detailed description: 
      Our goal is to develop a small size implantable device that can continually monitor glucose
      levels. The scientific objective of this application is to examine the efficacy of using
      implantable antennas to measure the glucose levels. The central hypothesis of this
      application is that the changes in the glucose levels in the medium surrounding the antenna
      will affect the antenna parameters such as input impedance and resonance frequency, and these
      changes can be used to predict the patient's glucose levels. We have formulated this
      hypothesis on the basis of our preliminary data, which will be detailed later, in the
      Preliminary Studies section. The rationale for the proposed research is that, once the
      correlation between the glucose levels and antenna parameters are determined, the design of a
      miniaturized long term glucose monitoring device will become a reality.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy adults
      
Keywords: antenna; continuous glucose monitoring; electromagnetic
Low Fluoroscopy Afib Ablation Registry
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational [Patient Registry]

Summary: 
      Prospective data collection of patients undergoing Atrial Fibrillation Ablation.
    

Detailed description: 
      Clinicians who have experience using low dose fluoroscopy including use of Carto Mapping
      system will consent patients to allow data collection and a 12 month f/up visit to track
      adverse events. Clinicians will follow a protocol which will be similar to their standard of
      care for ablations.
    

Intervention name(s): Ablation
Intervention type(s): Procedure
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who have persistant or paroxysmal atrial fibrillation
Appetite Regulation in Children With Failure to Thrive
Condition: Failure to Thrive
MeSH terms: Failure to Thrive
Study type: Observational

Summary: 
      Failure to thrive (FTT) is an expression for inadequate growth in the early childhood and
      thus, a sign of undernutrition. This study will include children with FTT, and compare with
      existing data from children with normal and excessive growth.

      The overall aim of this study is to explore whether 1) children who develop FTT with no
      organic explanation differ from healthy normal weight and overweight children in their basal
      level of appetite-regulating hormones and 2) if inadequate, normal and excessive growth in
      children can be partly predicted by variation in their gut microbiome and metabolome.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children with failure to thrive
      
Biospecimen description: 
      Plasma, serum, feces, urine
    
Keywords: Growth; Children; Appetite-regulating hormones; Gut Microbiota
Comparison of the Dual Task, Cognitive Skills and Physical Activity With Problematic Game Players and Control Subjects
Condition: Problematic Video Gaming; Cognitive Skill; Dual Task; Physical Activity
Study type: Observational

Summary: 
      This study was conducted to compare the cognitive skills, dual-task and physical activity
      status of individuals who play problem video games and healthy individuals, and to determine
      how much these skills are affected. The cognitive skills of individuals with video game
      playing problems and the control group were evaluated with the Montreal Cognitive Assessment
      Test, the Trail Making Test A & B sections, and the Stroop test. I evaluated dual tasks with
      10-meter walking test (single-double task) and Time Up and Go Test (single-double task).
      Physical activity levels were evaluated by International Physical Active Questionnaire. The
      average cognitive skills, dual tasks, and physical activity levels of the individuals in both
      groups were compared.
    


Intervention name(s): cognitive skill, dual task and physical activity assessment
Intervention type(s): Other
Intervention description(s): Montreal Cognitive Assessment Test, Trail Making Test (TMT) A & B sections and Stroop test for cognitive ability assessment, 10 meter walking test (single-double task) for dual task, Time up and Go test (single-double task), physical International Physical Activity Questionnaire was used for activity and The Exercise Benefit / Barriers Scale was used for exercise perception.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        University students in Hasan Kalyoncu University
Absolute Bioavailability of Lu AE58054 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the absolute bioavailability of the Lu AE58054 tablet formulation at steady
      state
    


Intervention name(s): Lu AE58054
Intervention type(s): Drug
Intervention description(s): Oral dosing: 90 mg Lu AE58054 as a single dose once and after a 3 days washout period, once daily for 7 days.
Intravenous dosing: 90 μg/not more than (NMT) 1000 nCi/37 kBq 14C-Lu AE58054 for intravenous infusion once on Day 10.
Intervention MeSH terms: (2-(6-fluoro-1H-indol-3-yl)-ethyl)-(3-(2,2,3,3-tetrafluoropropoxy)benzyl)amine
Intervention model: Single Group Assignment
Masking: None (Open Label)
The Association of Helicobacter Pylori in the Pathogenesis of Hyperemesis Gravidarum in Pregnant Women
Condition: Hyperemesis Gravidarum
MeSH terms: Hyperemesis Gravidarum
Study type: Observational

Summary: 
      The purpose of this study to explore the association between Hyperemesis Gravidarum in
      pregnant women and Helicobacter pylori infection.
    

Detailed description: 
      This study included 90 pregnant women during their first trimester who attended Ain Shams
      University Maternity Hospital antenatal clinic and admitted in the ward.

      Patients were divided into two groups: 46 cases of pregnant women with H.G and 44 healthy
      control pregnant women with no vomiting.

      Both groups were matched regarding the inclusion criteria which includes maternal age (18-40
      years), gestational age (<16 wks), and signs and symptoms of H.G for cases (vomiting
      affecting the general condition, ketonuria, weight loss) and excluding cases or controls with
      multiple gestation, hyadatiform disease or maternal disease causes vomiting such as ;
      pyelonephritis, gastroenteritis, cholecystitis or hepatitis.

      The two groups were subjected to full history taking, clinical examination, routine
      laboratory investigations (urine analysis, CBC, liver, kidney function tests Na, k, PT, PTT &
      INR) Abdominal ultrasound was done to assess fetal life and gestational age and to exclude
      gestational trophoblastic disease and multiple gestation pregnancy.H.Pylori infection was
      assessed by using One step H.pylori Stool Antigen Test.

      (CER TEST BIOTEC) pol. Industrial Rio Gallego II,Calle J, No 1, 50840, San Mateo de Gallego,
      Zaragoza (SPAIN) for the detection of H. pylori antigen.
    

Intervention name(s): helicopacter pylori stool antigen test (CER TEST BIOTEC)
Intervention type(s): Other
Intervention description(s): Stool samples were tested by using one step H.pylori stool antigen test (CER TEST BIOTEC)for the detection of H. pylori antigen in pregnant women with hyperemesis gravidarum
Other intervention name(s): (CER TEST BIOTEC)
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Study will include pregnant women in the first trimester attending Ain Shams University
        Maternity Hospital antenatal clinic and admitted in the ward.
Effect of Proton Pump Inhibitors on Endothelial Function
Condition: Endothelial Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      In this randomized controlled crossover study, the investigators propose to test the
      hypothesis that proton pump inhibitors (PPIs) increase plasma levels of asymmetric
      dimethylarginine (ADMA), which is a marker of endothelial dysfunction. The authors propose to
      evaluate ADMA concentrations and vascular function analysis in healthy volunteers and adults
      with a history of cardiovascular disease given PPI vs placebo for four weeks each.
    


Intervention name(s): Lansoprazole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Vitamin pill
Other intervention name(s): Prevacid
Intervention MeSH terms: Lansoprazole; Dexlansoprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Study of Nimotuzumab and Cisplatin/Radiotherapy for Locally Advanced Head and Neck Squamous Cell Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms; Neoplasms, Squamous Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to define the response and toxicities with the addition of
      Nimotuzumab to chemoradiation for head and neck cancer.
    

Detailed description: 
      Epidermal Growth Factor Receptor (EGFR) is overexpressed in Head and Neck Squamous Cell
      Carcinoma (HNSCC). EGFR pathway activation is associated with tumor growth, decreased
      apoptosis, and increased angiogenesis. These present a putative target for the use of EGFR
      inhibitors either in the form of small molecule inhibitors or monoclonal antibodies. Several
      studies have been advanced that suggest application of these targeted therapies show
      promising responses with little additional toxicity. The addition of EGFR monoclonal
      antibodies to radiation results in better response rates and locoregional control compared to
      radiation alone. Addition of EGFR monoclonal antibodies compared to chemotherapy alone also
      improves the response rates in patients with advanced HNSCC.

      Nimotuzumab is a humanized chimeric monoclonal antibody specific to the extracellular domain
      of EGFR. Several studies are ongoing and demonstrate promising efficacy of Nimotuzumab as
      monotherapy and in combination with radiation in HNSCC, and in combination with
      chemoradiation in Nasopharyngeal Carcinoma. This phase II clinical trial examines the
      feasibility of EGFR inhibition using Nimotuzumab in combination with concurrent
      chemoradiotherapy in locally advanced unresectable HNSCC. Successful and safe incorporation
      of an EGFR monoclonal antibody into the concurrent chemoradiation paradigm used to treat
      locally advanced HNSCC will represent an important advance in the optimisation of treatment
      for this group of patients.
    

Intervention name(s): Nimotuzumab; Cisplatin; Radiation
Intervention type(s): Drug; Drug; Radiation
Intervention description(s): Patients will receive nimotuzumab 200 mg weekly for 8 weeks. Nimotuzumab will be started together with concurrent chemoradiation, and continued 1 week after the completion of chemoradiation.; Concurrent chemotherapy with cisplatin 100 mg/m2 will be given on week 1, 4, and 7 of radiotherapy.; Concurrent radiotherapy will be given to the primary tumor and upper neck at 2 Gy per fraction, once a day, five days a week to a total of 70 Gy in 35 fractions in seven weeks.
Other intervention name(s): TheraCim-Rh3
Intervention MeSH terms: Nimotuzumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Head and Neck Squamous Cell Cancer; Chemoradiation; EGFR monoclonal antibody
A Study of Pharmacokinetics and Safety of Alefacept in Caucasian and Japanese Healthy Volunteers
Condition: Pharmacokinetics of Alefacept
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to compare the pharmacokinetic and pharmacodynamic properties
      and safety profile of alefacept in Caucasian and Japanese healthy subjects
    


Intervention name(s): alefacept; placebo
Intervention type(s): Drug; Drug
Intervention description(s): IC and SC; IV and SC
Other intervention name(s): Amevive; ASP0485
Intervention MeSH terms: Alefacept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Amevive; alefacept; pharmacokinetics; Japanese
Influence of Propranolol on Conditioned Pain Modulation
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      An extensive amount of studies indicate that conditioned pain modulation (CPM) test paradigms
      can be of use to evaluate the efficacy of the endogenous pain inhibition pathway in healthy
      controls and pain patients. A number of studies indicate that the autonomic nervous system
      (ANS) responds to painful stimulation by parasympathetic activity withdrawal and
      up-regulation of sympathetic activity (flight-or-fight mode), but it remains unknown whether
      these responses predict individual pain susceptibility or CPM efficacy and whether different
      pain modalities evoke different physiological stress responses, i.e. do individuals with low
      pain tolerance exhibit more vigorous ANS responses when subjected to controlled acute pain
      stimuli, and do high ANS responsiveness to pain coincide with altered psychophysical pain
      levels/CPM efficacy.

      This study aims to investigate the effect of ANS responsiveness on CPM paradigms and to
      investigate if an exogenous, pharmaceutically induced decrease in the sympathetic drive of
      the ANS will yield decreased CPM efficacy.
    


Intervention name(s): propranolol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Reduction of the ANS response
Intervention MeSH terms: Propranolol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Cocoa and Metabolic Health in Prediabetes
Condition: Prediabetes
MeSH terms: Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      The purpose of this study is to determine the impact of consuming cocoa on blood glucose
      levels, glucose metabolism, and other markers of pre-diabetes in overweight and/or obese
      individuals. Our hypothesis is that consumption of cocoa improves insulin sensitivity and
      glucose metabolism in subjects at risk for developing type-2 diabetes.
    


Intervention name(s): Cocoa; Placebo
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Cacao; Polyphenols; Prediabetic State; Blood Glucose; Glucose Intolerance; Diabetes Mellitus, Type 2; Obesity; Muscle, Skeletal; Endotoxins; Gut Permeability; Incretins; Metabolic Flexibility