bioihbjkbjnl/mcl2 huggingface dataset:
Cardiac Murmurs in Children: Predictive Value of Cardiac Markers
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital; Heart Murmurs
Study type: Observational

Summary: 
      Heart murmurs are commonly discovered in young children during clinical encounters in general
      practice. Heart murmurs might signal a structural cardiac disease that need to be treated,
      such as atrial septal defect. Thus, children with heart murmurs are routinely referred to
      comprehensive cardiac examination at a paediatric hospital department featuring
      echocardiography ('gold standard'). However, the great majority of such murmurs are innocent
      or physiological; ie., they do not represent a cardiac disorder. The prevalence of such
      innocent murmurs during routine random auscultation is estimated at 30 %.

      It would be advantageous if patients with a heart disease to a greater extent could be
      identified at the general practitioners' office:

        -  Healthy children would not be exposed to comprehensive cardiac examination

        -  The burden on the family would subside.

        -  Scarce medical resources in highly specialized departments would be better allocated, to
           the benefit of patients with real heart disease.

      The primary aim of this study is to establish the predictive value of cardiac markers in
      children with heart murmurs. Secondary aims are a) To do a pilot study of pediatric cardiac
      ultrasound examination in general practice; b) To establish age-adjusted reference range for
      cardiac markers in children, and c) To explore aspects of cardiovascular physiology in
      children.

      The investigators will include a total of 500 children aged 4 weeks to 10 years who is
      consecutively referred to the Dept. of Paediatrics, Akershus University Hospital, for
      assessment of heart murmurs. All participants will be subjected to clinical examination,
      symptom assessment, pulse oximetry, blood sampling (for troponin T, proBNP and other
      biomarkers), ECG recording, and echocardiography. A randomized subgroup of children will also
      undergo echocardiography performed by a general practitioner who has not received formal
      training in pediatric cardiology. The value of possible predictors will be assessed through
      the construction of Receiver Operating Characteristics (ROC) curves, and calculation of
      negative predictive value.
    


Intervention name(s): Clinical examination
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children consecutively referred to Akerhus University Hospital for spontaneously discovered
        cardiac murmur in general practice.
      
Biospecimen description: 
      Whole blood, serum, plasma
Histocompatibility Leukocyte Antigen (HLA)-A*0201 Restricted Peptide Vaccine Therapy in Patients With Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and time to progression of HLA-A*0201
      restricted epitope peptides URLC10, VEGFR1 and VEGFR2 emulsified with Montanide ISA 51.
    

Detailed description: 
      URLC10 has been identified as cancer specific molecules especially in non small cell lung
      cancer using genome-wide expression profile analysis by cDNA microarray technique. In a prior
      study, it has been shown that URLC10 is upregulated in human gastric tumors. VEGF receptor 1
      and 2 are essential targets to tumor angiogenesis, and we identified that peptides derived
      from these receptors significantly induce the effective tumor specific CTL response in vitro
      and vivo. According to these findings, in this trial, we evaluate the safety, immunological
      and clinical response of those peptides. Patients will be vaccinated twice a week for 8
      weeks. On each vaccination day, the URLC10-117 peptide (1mg), VEGFR1 peptide (1mg) and VEGFR2
      peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection. The
      patients will also receive oral chemotherapy (S-1) simultaneously. Repeated cycles of vaccine
      will be administered until patients develop progressive disease or unacceptable toxicity,
      whichever occurs first. In the phase I study, we evaluate the safety and tolerability of
      these peptide vaccines. In the following phase II study, we evaluate the immunological and
      clinical response of this vaccine therapy.
    

Intervention name(s): URLC10, VEGFR1 and VEGFR2
Intervention type(s): Biological
Intervention description(s): Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, the URLC10 peptide (1mg), VEGFR1 peptide (1mg) and VEGFR2 peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection in combination with S-1 chemotherapy.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Peptide Vaccine; URLC10; VEGFR1; VEGFR2
The Optimal Treatment Duration for Inspiratory Muscle Strengthening Exercises in Stroke Patients
Condition: Stroke, Complication; Respiratory Complication
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The first aim of this study is if there is any difference between 4 or 8 weeks of inspiratory
      muscle training ( IMT ) exercises groups and control groups in stroke survivors. The
      secondary aims of this study is if there is any difference in walking capacity (in 8th, 12th,
      24th weeks) and pulmonary complications (pneumonia incidences) in long term follow-ups (6
      months) in these aforementioned groups
    

Detailed description: 
      Stroke is one of the leading causes of death and disability. It is not only because of loss
      of extremity motions but also loss of inspiratory muscle strength. In this study we aimed to
      determine the optimum duration for inspiratory muscle training exercises for stroke survivors
      since there is not enough data about it in the literature.

      The study will include at least 54 patients in total and 18 in each groups ( two intervention
      and one control) . The patients will be evaluated for angina, chronic obstructive pulmonary
      disease, congestive heart disease; in these conditions the patients will be excluded from the
      study. Also in first examinations we will evaluate the maximal inspiratory pressure (MIP) of
      patients, of them the ones with MIP measurements above 80 mmH2O will also be excluded since
      it is the expected value in normal people.

      After admission and randomizing the patients, baseline measurements of MIP, 6-minutes walking
      test will be done. In intervention groups the patients will get 30 minutes of inspiratory
      muscle training exercises ( 15 minutes of two session each day) with threshold IMT device
      every weekday. And in control group, the patients will get sham intervention for 8 weeks. The
      MIP and 6-minutes walking test will be done in 8th,12th and 24th weeks. And also in 24th week
      we will record the pneumonia incidence if occured.
    

Intervention name(s): inspiratory muscle training; sham intervention
Intervention type(s): Other; Other
Intervention description(s): inspiratory muscle training will be done with Philips Respironics Threshold IMT device starting with resistance of % 50 of MIP value; in these group the patients will get sham intervention with Philips Respironics Threshold IMT device
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: three armed study with two interventions and one control group intervention group 1: inspiratory muscle training applied for 4 week intervention group 2: inspiratory muscle training applied for 8 week control group : will get sham intervention
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Breathing exercises; Cerebrovascular disease; Muscle strength; Rehabilitation; Stroke
Suggestive Effects on the Diameter of Coronary Arteries
Condition: Coronary Circulation
Study type: Interventional

Summary: 
      The aim of this randomized controlled pilot study was to answer the following questions:

        1. Is it possible to affect the diameter of coronary arteries through a placebo injection,
           which is administered intracoronarily together with a standardized verbal suggestion of
           coronary vasodilation?

        2. Is it possible to affect the diameter of coronary arteries through a pharmacologically
           underdosed nitroglycerine injection, which is administered intracoronarily together with
           a standardized verbal suggestion of coronary vasodilation?
    

Detailed description: 
      The present study is a randomized controlled double-blind single center study in order to
      investigate the effects of verbal suggestions ('vasodilatation') in combination with either a
      placebo-intervention (sodium chloride 0.9%) or an underdosed vasodilating medication
      (nitroglycerine) on the diameter of coronary arteries. 60 patients with a clinical indication
      to undergo a coronary angiogram were recruited in the German Heart Centre Munich. Patients
      with acute myocardial events and the necessity for coronary intervention were excluded from
      the study. Patients were randomized into one of four arms of the two experiments:

      Experiment A: Intracoronary (i.c.) placebo-infusion together with a standardized verbal
      suggestion of coronary vasodilation vs. i.c. placebo-infusion without verbal suggestion.

      Experiment B: i.c. infusion of a very low dosed nitroglycerin together with a standardized
      verbal suggestion of coronary vasodilation vs. i.c. nitroglycerine infusion without verbal
      suggestion.

      To our best knowledge this study is the first to investigate the modulating effects of verbal
      suggestions going along with medical interventions on the diameter of coronary arteries
      during heart catheterization.
    

Intervention name(s): Verbal suggestions
Intervention type(s): Behavioral
Intervention description(s): Verbal suggestions of a vasodilatory effect on cardiac vessels
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Coronary angiography; Placebo effect; Suggestion
Clinical Trial Examining Effects of Monosodium Glutamate (MSG) on Irritable Bowel Syndrome (IBS) and Fibromyalgia (FM)
Condition: Irritable Bowel Syndrome; Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Objective: Randomized, double blind, placebo-controlled, crossover, clinical trial to examine
      the effects of the food additive glutamate (in the form of MSG) on IBS and fibromyalgia.

      Setting and Subjects: The Fibromyalgia Research Database at OHSU will be utilized to identify
      and recruit fibromyalgia patients who also have IBS to OHSU study centers.

      Intervention: Approximately 60 male and female subjects aged 18-75 will be placed on a
      1-month glutamate-free elimination diet. Those that respond positively to the diet (we are
      estimating 30-40 subjects), will then be randomized to receive either a citrus drink
      containing 5 grams of MSG; or placebo (the citrus drink alone)on three consecutive days one
      week apart.

      The investigators are hypothesizing that those who react positively to the elimination diet
      will have symptom occurrence statistically more frequently when given the glutamate
      challenge, than when given placebo.
    


Intervention name(s): Glutamate additive-free diet; Placebo diet
Intervention type(s): Other; Other
Intervention description(s): All subjects will follow a diet for one month where all foods containing the additive glutamate have been removed. At the end of the one month diet, subjects who have responded positively to the diet will go onto the challenge arms of the study, where they will be randomized to receive placebo (mixed juice alone) for three days on one week, and 5 grams of glutamate in the mixed juice for three days on the other week.; Juice with nothing added.
Other intervention name(s): Glutamate will be used as a challenge in the form of MSG.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Irritable Bowel Syndrome; Fibromyalgia; Glutamate; Diet; Food additives
Phase 1 Bioavailability Study of SYR-322MET
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the relative bioavailability of alogliptin 12.5
      milligram (mg) and immediate-release metformin 1000 mg when administered as individual
      tablets and as a fixed-dose combination (FDC) product.
    

Detailed description: 
      The drug being tested in this study is called SYR-322MET (alogliptin 12.5 mg and metformin
      1000 mg FDC tablet). SYR-322MET is being tested to assess whether its pharmacokinetic
      properties (how it is processed by the body) are affected when administered as a FDC compared
      to administration of alogliptin and metformin alone. This study will look at lab results in
      people who take SYR-322MET.

      This crossover study will enroll approximately 24 participants. Participants will be randomly
      assigned (by chance, like flipping a coin) to one of two treatment sequences. All
      participants will receive both treatments over two periods; the order of receipt will be
      determined by the randomization code. All participants will receive the following study
      medications by the end of the study:

        -  Alogliptin 12.5 mg + Metformin 1000 mg as individual tablets

        -  SYR-322MET (alogliptin 12.5 mg and metformin 1000 mg fixed-dose combination [FDC]
           tablet)

      This single center trial will be conducted in Russia. The overall time to participate in this
      study is up to 63 days. Participants will make multiple visits to the clinic including two
      4-day periods of confinement to the clinic, and will be contacted by telephone 14 days after
      last dose of study drug for a follow-up assessment.
    

Intervention name(s): Alogliptin; Metformin Hydrochloride; SYR-322MET
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Alogliptin 12.5 mg tablets; Metformin hydrochloride 1000 mg tablets; SYR-322MET (alogliptin 12.5 mg and metformin 1000 mg) fixed-dose combination (FDC) tablets
Other intervention name(s): Vipidia; Glucophage
Intervention MeSH terms: Metformin; Alogliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug therapy
Effect of Reiki Application on Menopausal Symptoms
Condition: Menopausal Symptom
Study type: Interventional

Summary: 
      In this randomized controlled study, it was aimed to determine the effect of distant reiki on
      menopausal symptoms. Two different hypothesis teams have been established for the study.

      These; H0: There is no significant difference between the menopause rating scores of the
      women in the study group in which distant reiki was applied and the control group without
      distant reiki.

      H1: There is a significant difference between the menopause rating scores of the women in the
      study group in which distant reiki was applied and the control group without distant reiki.
    

Detailed description: 
      Parallel to the increase in life expectancy by years, the population of women living in the
      post-menopausal period is also increasing. In order to have a healthy menopause, which is an
      important part of women's life, it is thought that the distant reiki without health risks by
      women may be effective in reducing the symptoms of menopause experienced by women. In line
      with this information, it was aimed to determine the effect of distant reiki on menopausal
      symptoms. The study was carried out with menopausal women between the ages of 40-55 in Adana
      province in Turkey. Therefore, in the study, 48 women in the menopausal period between the
      ages of 40-55 was randomly assigned to reiki and control groups. Distant reiki application
      for 30 minutes three times a week for four weeks was applied individually to the study group.
      No intervention was made to the control group for a period of four weeks. The primary
      expected outcome of the research is the effect of distant reiki on menopausal symptoms of
      menopausal women. Results was applied three times in total, before the study and control
      application, 4 weeks and 8 weeks later.
    

Intervention name(s): Distant reiki
Intervention type(s): Other
Intervention description(s): Reiki; It is the transfer of energy to other people by the hands of the person who receives the theoretical training and attunement (initiation) from the reiki master, close or distant. When the hands are brought closer to the body in suitable positions or when the reiki practitioner visualizes the person in his/her thoughts, the energy flow starts spontaneously and the transferred energy is shaped according to the needs of the reiki recipient. The biggest advantage of Reiki; It is an easy and cost-effective method to ensure that the individual restores the balance between body, mind and spirit, has no side effects, has no negative effects on behavior and attitudes.
Other intervention name(s): Reiki
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, parallel, two-arm, randomized controlled clinical trial
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: Nursing; integrative practice; menopausal symptoms; reiki
Meta-Analysis Plan for Pooled Data for Studies VRX-RET-E22-303 and VRX-RET-E22-304
Condition: Epilepsy, Partial
MeSH terms: Epilepsy; Epilepsies, Partial
Study type: Observational

Summary: 
      The objective of this meta-analysis is to provide data on long-term safety and efficacy
      following the recent positive Committee for Medicinal Products for Human Use (CHMP) opinion
      for retigabine using pooled data from ongoing open-label extension (OLE) Studies
      VRX-RET-E22-303 and VRX-RET-E22-304.
    

Detailed description: 
      Data from the October 2009 data-cut of ongoing Studies VRX-RET-E22-303 (Study 303) and
      VRX-RET-E22-304 (Study 304) will be pooled, summarized, and published with the goal of
      providing updated long-term safety and efficacy information for subjects and prescribers
      following the recent positive CHMP opinion for retigabine for adjunctive use in patients with
      partial seizures. Studies 303 and 304 are the open-label extensions of two Phase 3 studies
      (VRX-RET-E22-301 and VRX-RET-E22-302), respectively. Studies 301 and 302 were randomized,
      double-blind, placebo-controlled, parallel-group, multicenter studies of 600 mg and 900 mg
      per day (Study 302) and 1200 mg per day (Study 301). All subjects who wished to enter the OLE
      studies and, in the opinion of the investigator, were expected to benefit from participation
      in the OLEs, entered a 6-week (Study 301) or 4-week (Study 302) transition phase in which
      their dose of retigabine was titrated to or maintained at 400 mg TID (Study 301) or 300 mg
      TID (Study 302). Upon completion of the Transition phase, subjects enrolled into the
      extension studies. Once enrolled in the OLE, doses could be adjusted within the range of 600
      mg to 1200 mg per day. Treatment in Studies 303 and 304 is planned to continue until
      regulatory approval and commercialization of retigabine or until the program is discontinued.
    

Intervention name(s): retigabine/ezogabine
Intervention type(s): Drug
Intervention description(s): dose range up to 1200 mg/day
Other intervention name(s): Trobalt
Intervention MeSH terms: Ezogabine
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients with partial onset seizures who have successfully completed the transition
        phase of VRX-RET-E22-301 and VRX-RET-E22-302.
      
Keywords: retention rate; epilepsy; responder rate; seizure freedom; discontinuation rate; safety assessment; reduction in seizure frequency; open-label
Safety and Tolerability of Soy Fiber
Condition: Safety Issues; Tolerance
Study type: Interventional

Summary: 
      This is a dose escalation trial in the elderly with obesity to determine the maximum
      tolerated dose of a novel dietary fiber from whole young soy pods (soy) delivered in foods.
    

Detailed description: 
      The tolerability to 10 g, 20 g, and 30 g of soy will be tested. At each dose, eight subjects
      will incorporate the foods containing soy into their usual diet for one week. The
      tolerability to each dose will be evaluated and fecal short chain fatty acids will be
      measured as a biomarker of compliance. Subjects who satisfy the eligibility criteria and
      express willingness to consume the study foods will be enrolled.
    

Intervention name(s): Food
Intervention type(s): Other
Intervention description(s): Soy-fiber containing food
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Dose escalating cross over trial
Masking: None (Open Label)
Primary purpose: Other
Trial of CPX-351 in Newly Diagnosed Elderly AML Patients
Condition: Acute Myeloid Leukemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The study investigates if CPX-351 will be a) more effective than the standard AML treatment
      and b) more tolerable than the standard AML treatment regimens.

      The study compares the investigational product CPX-351 vs the standard treatment for AML in
      this patients age group.
    

Detailed description: 
      This study is a randomized, open-label, parallel-arm, fixed-dose, standard therapy controlled
      Phase IIB trial. Study enrollment duration is expected to be approximately 12-18 months. On
      entry, patients are randomized to receive either CPX-351 or standard induction treatment with
      cytarabine and daunorubicin("7 and 3" regimen).

      Patients are stratified to balance the likelihood of obtaining a CR and the duration of CR
      between the two arms.
    

Intervention name(s): CPX-351; Cytarabine; Daunorubicin
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Cytarabine; Daunorubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute; Myeloid; Leukemia; elderly; Newly; Diagnosed