bioihbjkbjnl/mcl2 huggingface dataset:
Neurology Measures in FA Children
Condition: Friedreich Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Friedreich Ataxia
Study type: Observational [Patient Registry]

Summary: 
      The purpose of this study is to identify ways to follow progression of Friedreich's Ataxia
      (FA) and be able to measure changes over time in children with FA. Participants will have
      biannual visits to observe how the disease progresses over time and determine the rate of
      progression.

      Funding Source- Food and Drug Administration Office of Orphan Products Development (FDA
      OOPD).
    

Detailed description: 
      Investigators seek to identify biological and clinical tests to be used in future clinical
      trials. The purpose of this research study is to learn more about Friedreich's Ataxia (FA)
      progression in children. There will be biannual visits which will include a core set of tests
      and procedures. These include: a collection of medical history, detailed neurological exam,
      ataxia scales, and health questionnaires. At each visit, blood and cheek swab samples will be
      obtained to monitor frataxin levels.

      A select number of Children's Hospital of Philadelphia (CHOP) participants will have the
      opportunity to participate in further procedures to better understand how FA affects
      different tissues. These include a Magnetic Resonance Imaging (MRI) scan and a Motor Evoked
      Potentials (MEP) procedure.

      The MRI scan analyzes how muscle activity is affected in FA. The magnet will be used to
      capture images of the calf muscle before and after exercising on an ergonomic foot pedal.

      The MEP procedure measures how strong the connection is between the brain's motor cortex and
      a selected body part, specifically the participant's dominant hand.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This study will primarily take place at the Children's Hospital of Philadelphia (CHOP),
        with a select number of subjects only participating in the clinical testing at the
        University of Florida and University of California Los Angeles (UCLA). The investigators
        expect to recruit approximately 100 children across all three sites and study each of them
        over a 3 year period. Children with a genetically or clinically confirmed diagnosis of
        Friedreich's Ataxia (FA) will be offered participation.
      
Biospecimen description: 
      Whole blood and plasma to measure frataxin protein and other present biomarkers.

      Buccal cells (inner cheek cells) to measure frataxin protein levels.
    
Keywords: Friedreich; Ataxia; FRDA; FA; Friedrich Ataxia (FRDA)
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MDCO-2010 in Patients Undergoing Elective Coronary Artery Bypass Graft Surgery
Condition: Coronary Artery Bypass Graft; Cardiopulmonary Bypass
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to demonstrate that periprocedural infusion of escalating doses
      of MDCO-2010 is safe and tolerated in patients undergoing elective CABG surgery, to
      characterize the single dose pharmacokinetics of MDCO-2010, to investigate the effect of
      MDCO-2010 on pharmacodynamics (biomarkers of fibrinolysis and coagulation parameters), and to
      investigate the effect on exploratory clinical endpoints of bleeding, transfusion
      requirements and reexploration.
    

Detailed description: 
      This protocol describes a study of the investigational drug MDCO-2010 as a haemostasis
      modulator in patients undergoing elective Coronary Artery Bypass Graft (CABG) surgery
      involving a cardiopulmonary bypass (CPB).

      Perioperative bleeding is a serious complication that adversely affects the morbidity and
      mortality of cardiac surgery. To alleviate this complication, prophylactic antifibrinolytic
      therapies are now widely accepted as a strategy to inhibit excessive fibrinolysis.

      MDCO-2010, a synthetic small molecule, is a direct inhibitor of plasmin and plasma
      kallikrein. Both of these have been implicated with impaired haemostasis. In addition, potent
      inhibition of coagulation factors Xa, XIa and activated Protein C has been demonstrated.
      Thus, MDCO-2010 has the potential to mitigate excessive fibrinolysis and thrombin generation
      during cardiac surgery involving a cardiopulmonary bypass. In particular the latter is
      supposed to provide additional benefits beyond reducing transfusion requirements.
    

Intervention name(s): MDCO-2010; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): MDCO-2010 solution for infusion. Dosage: Pump priming dose; Loading dose infusion over 6 minutes; Maintenance infusion for duration of surgery; Commercially available NaCl
Other intervention name(s): CU-2010
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cardiac surgery; coronary artery bypass graft; cardiopulmonary bypass; haemostasis modulator; blood loss; direct inhibitor of plasmin and plasma kallikrein; CABG; CPB
Effect of Magnesium Administration in Subjects With Family History of Diabetes or Metabolic Syndrome
Condition: Family History of Metabolic Syndrome; Family History of Diabetes
MeSH terms: Diabetes Mellitus; Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Magnesium is the second most abundant ion in human cells and plays fundamental roles in
      several enzymatic reactions: it is involved in ATP production, in the phosphorylation of
      proteins, in glucose metabolism and in the contraction of cytoskeleton.

      Several epidemiological studies demonstrated that low dietary magnesium intake is inversely
      associated with diabetes mellitus, hypertension and metabolic syndrome.

      Magnesium could be related to important haemodynamic and metabolic anomalies: at vascular
      level it acts as an antagonist of calcium, especially in vascular smooth muscle cells, thus
      its deficit could enhance vascular contraction; with regard to glucose metabolism, magnesium
      is involved in the physiopathological mechanism of insulin resistance, through a reduction in
      cellular uptake of glucose. This condition and the subsequent compensatory hyperinsulinemia
      can ultimately lead to increased synthesis of proinflammatory cytokines and to endothelial
      dysfunction. Thus, magnesium depletion and subsequent alterations can increase the risk of
      developing vascular disease such as atherosclerosis and has been associated with
      cardiovascular events.

      Several clinical trials have explored the possible beneficial effect of magnesium
      supplementation on blood pressure, plasma lipids and insulin resistance but the results are
      often contradictory. One of the possibilities for these unclear results could be that in some
      of them the interventions started too late when haemodynamic and metabolic changes are more
      difficult to revert.

      The investigators hypothesis is that magnesium supplementation in a population at increased
      genetic risk of developing metabolic syndrome but without it could improve blood pressure and
      the other metabolic syndrome related components.

      Thus, the aim of the present study is to evaluate the effect of oral supplementation of
      magnesium (16.2 mmol/day of magnesium pidolate) on metabolic syndrome's components in a
      sample of 15 subjects who are at increased risk of developing metabolic syndrome since have a
      positive familiar history of type II diabetes mellitus and/or metabolic syndrome(AHA/NHLBI
      criteria).
    


Intervention name(s): magnesium pidolate; placebo
Intervention type(s): Drug; Drug
Intervention description(s): administration of 8.1 mmol bid of magnesium pidolate; administration of 8.1 mmol bid of placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: magnesium; metabolic syndrome; diabetes; family history
The Effect of Therapeutic Touch on Colic Symptoms in Infantile Colic Infants: A Randomized Controlled Study
Condition: Infantile Colic; Therapeutic Touch
MeSH terms: Colic
Study type: Interventional

Summary: 
      Aim: The purpose of this study is to determine the effect of therapeutic touch applied to
      infants with infantile colic on infant colic scale score, crying and sleep time.

      Method: The study will be conducted as a single-blind, randomized controlled trial. The
      population of the study will be infants who come to the Pediatrics Outpatient Clinic and are
      diagnosed as infantile colic according to the evaluation of the pediatrician and have no
      other health problems. The infants will be divided into two groups as intervention and
      control groups according to stratified block randomization in the computer environment. After
      the randomization, therapeutic touch will be applied to the intervention group. No method
      will be applied to the control group.
    

Detailed description: 
      The research will be carried out with two groups as intervention and control groups. Sample
      size of the study has been determined by the power analysis, in line with the results
      obtained from the studies which have been conducted using a similar research method.
      According to the analysis results, it has been calculated as 27 for each group and 54 in
      total. Considering the possible case losses, 20% of the sample was increased. The sample
      consisted of 64 babies, 32 intervention and 32 control. Mothers of the infants meeting the
      study inclusion criteria will be informed both in written and verbally. Written consent will
      be obtained. The infants will be divided into two groups according to stratified block
      randomization in the computer environment. The infants will be stratified by gender and age.
      After the randomization, therapeutic touch will be applied to the intervention group. No
      method will be applied to the control group by the researcher. In obtaining research data, 4
      tools will be used: "Mother-infant Information Form", "Infantile Colic Scale", Crying Time
      Registration Form and Sleep Time Registration Form.
    

Intervention name(s): Therapeutic Touch
Intervention type(s): Other
Intervention description(s): Therapeutic Touch will be applied to infants for 3 consecutive days, once a day, 10 minutes at any time during the day. There will be a four-day break. The Therapeutic Touch will be done a total of 6 times in 2 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study will be conducted as a single-blind, randomized controlled trial.
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Therapeutic Touch; infantile colic; infant; nursing; Symptom
Safety and Efficacy of the SL PLUS and the SL PLUS MIA Hip Stem
Condition: Coxarthrosis
MeSH terms: Osteoarthritis, Hip
Study type: Interventional
Phase: Phase 4

Summary: 
      Randomized controlled trial using two types of hip stems, SL PLUS MIA (control group) and SL
      PLUS (study group).

      We compare primary and secondary stability of both hip stems for radiographic outcome using
      EBRA (Ein-Bild-Roentgen-Analyse) after a two year follow-up period.

      Further, we compare all differences in clinical outcome using Harris Hip Score, Oxford hip
      score and radiographic findings.
    

Detailed description: 
      This study is a monocentric study, randomized and controlled including two types of hip
      stems: SL PLUS MIA (control group) and SL PLUS (study group).

      Each group will include 45 patients where a number of 5 patients for each group calculated
      extra in case of loss.

      Patients will be followed after

        -  6 weeks

        -  6 months

        -  12 months

        -  24 months. Radiographs are taken in a-p and lateral view using a standard protocol.
           Primary and secondary stability of both hip stems will be analyzed using the EBRA
           software (Ein-Bild-Roentgen-Analyse, University of Innsbruck, Austria) after the
           completion of the two year follow-up.

      Further, we compare all differences in clinical outcome using Harris Hip Score, Oxford hip
      score and radiographic findings such as radiolucent lines.
    

Intervention name(s): primary total hip arthroplasty
Intervention type(s): Procedure
Intervention description(s): All patients eligible to the study criteria will be included. A total hip arthroplasty unilateral will be performed.
Other intervention name(s): SL-PLUS, SL-PLUS MIA, Lateralized hip stem
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: hip arthroplasty; primary stability; secondary stability; EBRA
Propafenone Versus Amiodarone in Septic Shock
Condition: Supraventricular Arrhythmia; Septic Shock
MeSH terms: Shock, Septic; Arrhythmias, Cardiac; Shock
Study type: Interventional
Phase: Phase 4

Summary: 
      Arrhythmias accompany septic shock in increased rates than in other ICU cohorts and their
      presence and management are related to patient´s prognosis. 1c class antiarrhythmics are
      seldom administered in intensive care due to a dose dependent toxicity published in case
      reports and unfavourable outcome reported in a few prospective trials done on cardiology
      patients. The papers on 1c class antiarrhythmics do not take into consideration a complex
      haemodynamic assessment using echocardiography. The authors have recently presented a
      retrospective study on SV arrhythmias in septic shock patients demonstrating favourable
      effect and safety of propafenone which showed higher antiarrhythmic efficacy than amiodarone.
    

Detailed description: 
      Primary aim is to verify the conclusions of the retrospective study, i.e. efficacy and safety
      of propafenone, in a prospective blinded randomized trial performed in two large intensive
      care units. Secondary aims are to monitor the electromechanics of left atrium in patients
      with SV arrhythmias in septic shock.
    

Intervention name(s): Propafenone i.v.; Amiodarone i.v.
Intervention type(s): Drug; Drug
Intervention description(s): Treatment; Treatment
Other intervention name(s): Antiarrhythmic therapy; Antiarrhythmic therapy
Intervention MeSH terms: Amiodarone; Anti-Arrhythmia Agents; Propafenone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Supraventricular Arrhythmia; Septic shock; Propafenone; Amiodarone; Intensive Care
Effect of Different Dosing Regimens of Clopidogrel Before Elective Percutaneous Coronary Intervention (PCI) on Platelet Function
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      Adequate platelet inhibition before percutaneous coronary intervention (PCI) reduces
      peri-procedural and long-term ischemic complications. Documented reduced response to
      clopidogrel has been associated with subsequent major adverse cardiovascular events.
      Strategies to optimize platelet inhibition pre-PCI are under investigation.

      This study sought to evaluate the effect on platelet aggregation of four different dosing
      regimens of clopidogrel given before elective PCI.
    


Intervention name(s): Clopidogrel; Clopidogrel; Clopidogrel; Clopidogrel
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): clopidogrel 300 mg on the day prior to angiography; clopidogrel 600 mg on the day prior to angiography; clopidogrel 300 mg followed by 75 mg daily started one week prior to angiography; clopidogrel 300 mg followed by 150 mg daily started one week prior to angiography
Intervention MeSH terms: Clopidogrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: angioplasty; clopidogrel; coronary artery disease; platelets; Percutaneous coronary intervention
Compare Ceftazidime-Avibactam + Metronidazole Versus Meropenem for Hospitalized Adults With Complicated Intra-Abdominal Infections
Condition: Complicated Intra-Abdominal Infection
MeSH terms: Infections; Communicable Diseases; Intraabdominal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effects of Ceftazidime Avibactam plus
      Metronidazole compared to Meropenem for treating hospitalized patients with complicated
      intra-abdominal infections.
    

Detailed description: 
      A Phase III, Randomized, Multicenter, Double Blind, Double-Dummy, Parallel-Group, Comparative
      Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam Plus
      Metronidazole Versus Meropenem in the Treatment of Complicated Intra-Abdominal Infections In
      Hospitalized Adults
    

Intervention name(s): CAZ-AVI; Metronidazole; Meropenem
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ceftazidime 2000 mg and 500 mg of avibactam; 500 mg of Metronidazole; 1 gram of Meropenem
Intervention MeSH terms: Metronidazole; Meropenem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ceftazidime; Meropenem; Metronidazole; Anti-Bacterial Agents; Anti-Infective Agents; Antiprotozoal Agents; Antiparasitic Agents; cIAI, Complicated Intra-Abdominal Infection
A Study to Investigate CSL312 in Subjects With Hereditary Angioedema (HAE)
Condition: Hereditary Angioedema
MeSH terms: Angioedema; Angioedemas, Hereditary
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, randomized, placebo-controlled, parallel-arm, phase 2 study to
      investigate the clinical efficacy, pharmacokinetics, and safety of CSL312 as prophylaxis to
      prevent attacks in subjects with HAE.
    


Intervention name(s): Factor XIIa antagonist monoclonal antibody; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use; Buffer without active ingredient
Other intervention name(s): CSL312
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects are assigned to 1 of 2 or more groups in parallel for the duration of the study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study to Assess the Relative Oral Bioavailability of a Single Dose of JNJ-63623872/Oseltamivir Fixed-dose Combination Tablet and Single Agent Concept Formulations of JNJ-63623872 Compared to Their Respective Reference Formulation in Healthy Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the rate and extent of absorption of JNJ63623872
      following administration of a single oral dose of 2*300 milligram (mg) given as 2 concept
      single agent tablet formulations compared to the administration of 2*300 mg JNJ63623872
      reference tablets, under fasted conditions in healthy adult participants and to assess the
      rate and extent of absorption of JNJ63623872 and oseltamivir following administration of a
      single oral dose of 2*300 mg/37.5 mg JNJ63623872/ oseltamivir given as a concept fixed dose
      combination (FDC) tablet formulation compared to the coadministration of 2*300 mg JNJ63623872
      tablets (reference formulation) and 1*75 mg oseltamivir capsule, under fasted conditions in
      healthy adult participants.
    


Intervention name(s): JNJ-63623872; Oseltamivir
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive JNJ-63623872 600 mg (2*300 mg) oral tablets in Panel 1 and 2 under Fasted conditions.; Participants will receive Oseltamivir 75 mg (1*75 mg) oral capsule (reference) in Treatment D of Panel 2 and Oseltamivir 75 mg administered as JNJ-63623872/37.5 mg Oseltamivir oral FDC tablet concept formulation (test 3) in Treatment E of Panel 2.
Intervention MeSH terms: Oseltamivir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Food Antigen in Eosinophilic Esophagitis
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Observational

Summary: 
      The relationship or effect of food antigen (wheat based soy sauce) in eosinophilic
      esophagitis. It is believed that when food antigens are exposed to the esophageal tissue it
      starts an chronic allergy-based inflammation. This will be analyzed with the esophageal
      biopsies and the mucosal impedance probe.
    

Detailed description: 
      One of the putative mechanisms of eosinophilic esophagitis is exposure of food antigens to
      antigen recognition cells in the esophageal mucosa that initiates a chronic allergy-based
      inflammatory response . It is believed that this exposure is facilitated through dilation of
      the intercellular spaces (DIS) between esophageal epithelial cells (termed spongiosis). This
      is substantiated by several studies which have demonstrated that: first, DIS is commonly
      found in biopsies from patients with active EoE and reverses with steroid therapy; second,
      DIS correlates to physiologic demonstration of increased esophageal epithelial permeability
      as shown through transepithelial small molecule flux in mucosal biopsies appraised in Ussing
      chambers and increased conductivity of electric current as measured in a mucosal impedance
      probe (Katzka, et al., in press, Clin Gastroenterol Hepatol). Although these mechanisms make
      intuitive sense, no one has shown the presence of food antigen in esophageal mucosa after
      ingestion and the correlation of this presence to dilation of intercellular spaces.
    

Intervention name(s): Antigen (wheat base soy sauce) spray
Intervention type(s): Other
Intervention description(s): Patients having a clinically indicated endoscopy for Eosinphilic Esophagitis will have two biopsies from the esophageal body, 10 cm above the gastroesophageal junction. After biopsies are taken, approximately 10 cc of wheat based soy sauce will be sprayed though an endoscopic catheter onto the esophageal mucosa. The endoscopic examination will be completed and Two additional endoscopic biopsies will be taken 10 cm above the gastroesophageal junction.
Other intervention name(s): Wheat based soy sauce
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Eosinophilic Esophagitis patients
      
Keywords: Eosinophilic