bioihbjkbjnl/mcl2 huggingface dataset:
Preoperative Nutritional Intervention and Outcomes of Children Submitted to Heart Surgery for Congenital Heart Diseases
Condition: Congenital Heart Disease; Malnutrition
MeSH terms: Heart Diseases; Heart Defects, Congenital; Malnutrition
Study type: Interventional

Summary: 
      The hypothesis of this study is a nutrition preoperatively in infants and children undergoing
      elective cardiac surgery with cardiopulmonary bypass leads to improvement in nutritional
      status, intervention, and that this results in good postoperative results.
    

Detailed description: 
      If this hypothesis is confirmed, there will be subsidies for systematic implementation of
      nutritional interventions in patients seen in service.
    

Intervention name(s): Nutritional intervention
Intervention type(s): Dietary Supplement
Intervention description(s): Consultation with a dietitian, nutritional recommendations to achieve the expected energy expenditure, with or without supplementation with enriched formulas.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Children; Congenital heart disease; Nutritional status; Bioelectrical impedance
Improving Information Extraction From EEG on Cerebral Anesthetic Drug Effects
Condition: Anesthesia
Study type: Interventional

Summary: 
      This is an interventional, randomized controlled study in health volunteers that involves
      collecting data on raw EEG waves measuring various combinations of anesthetic drugs during
      standardized drug titration.
    


Intervention name(s): SedLine EEG sensor
Intervention type(s): Device
Intervention description(s): Test subjects in each group will receive the same device intervention (SedLine EEG) to monitor their EEG waves.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Electroencephalography; pharmacological
Efficacy of a New Symbiotic Formulation in Children With Familial Hypercholesterolemia
Condition: Dyslipidemia; Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia; Dyslipidemias
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Probiotics have been proposed for the treatment of dyslipidemia. the investigators aimed to
      evaluate efficacy, tolerability and safety of a new symbiotic formulation containing a
      combination of probiotic and prebiotics and amine in the treatment of children affected by
      familial hypercholesterolemia (FH).
    

Detailed description: 
      FH subjects, aged 6-12 years, consecutively observed a Tertiary Center for Pediatric
      Nutrition were randomly allocated to two groups of intervention for 6 months: active group,
      received a low saturated fats diet plus the symbiotic (2.5×109cfu, bid) for 6 months; control
      group, received low saturated fats diet alone. All children received written indications for
      low saturated fats diet. The plasmatic lipid profile was assessed by peripheral blood
      sampling at T0 and T1.
    

Intervention name(s): Lactobacillus paracasei B21060; low satured diet
Intervention type(s): Dietary Supplement; Other
Intervention description(s): combination of probiotic (Lactobacillus paracasei B21060) and prebiotics (arabinogalactans, xyloooligosaccarides) and amine (L-glutamine)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Trivalent, Live, Cold Adapted Influenza Vaccine (CAIV-T) Against Inactivated Influenza Vaccine (TIV) in Children 6-59 Months of Age
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to estimate the relative efficacy and assess the
      safety of CAIV-T compared to TIV.
    


Intervention name(s): Liquid CAIV-T
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Prevention
An Exploratory Open Label Study of Adjunctive L-lysine Treatment in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      The objective of the present study was to investigate the possibility of using L-lysine, an
      amino acid that occurs naturally in food and which interferes with nitric oxide (NO)
      production, for the treatment of schizophrenia. L-lysine, 6 g/day, was administered to ten
      patients with schizophrenia as an add-on treatment to conventional antipsychotic treatment.
      The study was designed as a single-blinded, cross-over study where patients were randomly
      assigned to initial treatment with either L-lysine or placebo and screened at baseline, after
      four weeks when treatment was crossed over, and after eight weeks when treatment was
      terminated. The four-week L-lysine treatment regimen caused a significant increased in blood
      concentration of the amino acid and was tolerated well. The analysis of outcome measures
      showed a significant decrease in symptom severity as measured by the Positive and Negative
      Syndrome Scale (PANSS). Furthermore, the patient's ability to solve the Wisconsin Card
      Sorting Task (WCST) was significantly improved indicating increased problem solving capacity
      and cognitive flexibility. Subjective reports from three of the patients also indicated
      decreased symptom severity and enhanced cognitive functioning. In summary, these findings
      suggest potential beneficial effects of L-lysine treatment on symptom severity and cognitive
      deficits in patients with schizophrenia.
    


Intervention name(s): L-lysine
Intervention type(s): Drug
Intervention description(s): 6 g/day for four weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Schizophrenia; L-lysine; PANSS
Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study
Condition: Migraine; Migraine Disorders; Migraine Headache
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a 128-week open-label study to assess the long-term safety and tolerabilty of the
      monoclonal antibody erenumab in migraine patients.
    

Detailed description: 
      This was an open-label, multi-center, single arm study with flexible dosing allowing both
      dose adjustment and one drug holiday per patient.

      The study design consisted of 3 parts:

        -  Screening Epoch (0 - 2 weeks): required for all patients to assess initial eligibility.
           Eligible patients came from study CAMG334ADE01 (NCT03828539).

        -  Open-label Treatment Epoch (128 weeks): Individual patients were treated for 128 weeks.
           In this open-label treatment phase, the erenumab dose could be adjusted from 70 mg to
           140 mg or vice versa at the discretion of the physician at any scheduled study visit.
           Additionally, a voluntary single treatment interruption ('drug holiday') of up to 24
           weeks (approximately six months) could be introduced after at least 12 weeks of
           treatment in the open-label Treatment Epoch.

        -  Follow-up Epoch (4 weeks): A Follow-Up Visit 4 weeks after the last regular study visit
           (8 weeks after last investigational medicinal product [IMP] application) was required as
           part of routine safety monitoring.
    

Intervention name(s): Erenumab
Intervention type(s): Biological
Intervention description(s): Erenumab was supplied as a pre-filled pen (auto-injector) for subcutaneous injection.
Other intervention name(s): AMG334; Aimovig
Intervention MeSH terms: Erenumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: migraine; episodic migraine; chronic migraine; headache; erenumab; AMG334; aimovig; monoclonal antibody; CGRP-receptor antibody
Prevalence of Comorbidities in Patients Undergoing Oncosurgeries at Tertiary Cancer Institute in North India.
Condition: Comorbidities and Coexisting Conditions
Study type: Observational

Summary: 
      Investigators plan to study the prevalence of comorbidities in patients undergoing
      oncosurgeries
    

Detailed description: 
      Plan to study the prevalence of Coronary Artery Disease, Hypertension, Diabetes Mellitus,
      Hypothyroidism, History of Corona Virus infection in patients undergoing oncosurgeries.

      In the Pre anesthesia checkup patients age , sex , Weight in kilograms, Height in centimeters
      , pulse rate, Blood Pressure will be noted and value>140/90 mmHg will be taken as
      hypertensive. History will be obtained about diagnosed Coronary Artery Disease , Diabetes
      Mellitus, Hypertension , Hypothyroidism , History of previous Corona Virus Infection (RT-PCR
      Test Positive) .Relevant investigations Electrocardiography and Echocardiography for
      assessment of Coronary Artery Disease. Fasting or Random Blood Sugar , Thyroid Function Test
      will be done .

      Fasting Blood Sugar >126 milligram/ Decilitre and Random Blood sugar >200mg/dL will be taken
      as diabetic. TSH more than 5 micro IU/mL will be hypothyroid .
    

Intervention name(s): To study comorbidities in patients undergoing Oncosurgeries
Intervention type(s): Other
Intervention description(s): In the Preoperative Anaesthesia checkup we will study prevalence of comorbidities as Coronary artery Disease, Hypertension, Diabetes Mellitus , Hypothyroidism and prior Corona Virus Infection in patients undergoing Oncosurgeries
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients undergoing Oncosurgeries will be studied for prevalence of comorbidites.
      
Keywords: comorbidities; oncosurgery
Effect of scFOS on Increase in Stool Frequency in Constipated People
Condition: Functional Constipation; Healthy
MeSH terms: Constipation
Study type: Interventional

Summary: 
      The study aims to evaluate the effects of short-chain fructo-oligosaccharides on the
      frequency and consistency of stools in subjects with functional constipation.
    

Detailed description: 
      This randomized, placebo-controlled, double-blind study aims to evaluate the effects of
      short-chain fructo-oligosaccharides on the frequency and consistency of stools in subjects
      with functional constipation.
    

Intervention name(s): scFOS; Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): daily intake for 6 weeks; daily intake for 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Family Exergaming: A Research Study Testing a Videogame Intervention to Increase Physical Activity for Families
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to determine if an interactive game (Dance Dance Revolution/DDR)
      can promote healthy physical activity for the health of all family members
    


Intervention name(s): Exergame (DDR)
Intervention type(s): Behavioral
Intervention description(s): Use of an active videogame vs. pedometers given to entire families to promote physical activity.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Obesity; Exergames; Videogames; Prevention; Family; Dance Dance Revolution; Pedometer
Safety Study of ME-609 for Treatment of Herpes Simplex Labialis in Adolescents
Condition: Herpes Labialis
MeSH terms: Herpes Simplex; Herpes Labialis
Study type: Interventional
Phase: Phase 3

Summary: 
      The Purpose of this study is to evaluate the safety of ME-609 for the treatment of recurrent
      herpes labialis in adolescents.
    

Detailed description: 
      The objective of the study was to evaluate the safety of ME-609 for the treatment of herpes
      labialis recurrences in immunocompetent adolescents, 12 - 17 years of age, following a 5-day
      treatment with 5-time daily topical administration.
    

Intervention name(s): ME-609
Intervention type(s): Drug
Intervention description(s): Topical treatment 5 times daily for 5 days
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy Study of KAI-1678 to Treat Subjects With Postoperative Pain
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether KAI-1678 is effective in the treatment of
      postoperative pain following total hip or total knee replacement.
    


Intervention name(s): Placebo; KAI-1678; Ketorolac Tromethamine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subcutaneous infusion-once over 4 hours; Subcutaneous infusion-once over 4 hours; Active comparator, IV infusion, once
Other intervention name(s): Active drug; Ketorolac
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Ketorolac / therapeutic use; Analgesics. Non-narcotic / therapeutic use; Arthroplasty, replacement hip; Arthroplasty, replacement knee; Pain measurement / drug effect; Pain postoperative / drug therapy
Study to Measure Cerebrospinal Fluid Mutant Huntingtin Protein in Participants With Early Manifest Stage I or Stage II Huntington's Disease
Condition: Huntington's Disease
MeSH terms: Huntington Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is designed as a multi-site, prospective, 15-month longitudinal, cohort study
      measuring CSF mHTT in participants with early manifest Stage I or Stage II Huntington's
      Disease (HD).
    


Intervention name(s): No Study Drug was Administered in this Study
Intervention type(s): Other
Intervention description(s): No study drug was administered in this study
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Manual Therapy in Chronic Shoulder Pain Treatment
Condition: Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Interventional

Summary: 
      Background: Passive oscillatory mobilizations are often employed by physiotherapists to
      reduce shoulder pain and increase function. However, there is little data about the
      neurophysiological effects of these mobilizations.

      Objectives: To investigate the initial effects of an anteroposterior (AP) shoulder joint
      mobilization on measures of pain and function in overhead athletes with chronic shoulder
      pain.
    

Detailed description: 
      Design: Double-blind, controlled, within-subjects repeated-measures design Method: Thirty-one
      overhead athletes with chronic shoulder pain participated. The effects of a 9-min, AP
      mobilization of the glenohumeral joint were compared with manual contact and no-contact
      interventions. Pressure pain threshold (PPT), range of movement (ROM), muscle strength,
      self-reported pain, and disability were measured immediately before and after each
      intervention.
    

Intervention name(s): Mobilization to the glenohumeral joint; The manual contact condition; No-contact condition
Intervention type(s): Procedure; Procedure; Other
Intervention description(s): The treatment condition consisted on the application of a passive rhythmic AP mobilization to the glenohumeral joint of the affected shoulder. In particular, a Grade III AP glide to the humeral head with the arm positioned in 90º of glenohumeral abduction and full internal rotation was used. The posterior gliding force to the humeral head was applied maintaining the glide at right angles to the plane of movement and at a frequency of 2 Hz which was controlled by means of a metronome. The arm was returned to its original position between each set.; During the manual contact condition the therapist positioned the patient in a mid-range position of glenohumeral abduction and internal rotation and applied the hands to the same contact point as in the treatment condition. However, a simulated posterior glide was performed but with minimal pressure actually applied. The number of repetitions and sets were as per the treatment condition.; During the no-contact condition, the subject remained in the initial starting position thorough the entire session but there was no manual contact between the therapist and the participant. The total treatment time was the same as per the other conditions.
Other intervention name(s): Joint Manipulation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
rTMS for Working Memory Deficits in Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Memory Disorders; Schizophrenia; Psychotic Disorders
Study type: Interventional

Summary: 
      In this study, the investigators will be examining the effects of repetitive transcranial
      magnetic stimulation (rTMS) on memory deficits in individuals with schizophrenia and
      schizoaffective disorder. Half of the study participants will be chosen by chance to receive
      active rTMS stimulation while half will be chosen by chance to receive sham rTMS. Sham rTMS
      will feel the same as active rTMS only there will be no direct brain stimulation. This is
      necessary to ensure that active rTMS is efficacious in the enhancement of memory in
      individuals with schizophrenia. Based on results from a recently published pilot study, the
      investigators propose that active rTMS treatment will result in a significant improvement in
      working memory performance compared to sham rTMS treatment.
    

Detailed description: 
      This study is a randomized, double blind, sham controlled study to evaluate the efficacy of
      repetitive transcranial magnetic stimulation as a treatment for working memory deficits in
      individuals with schizophrenia or schizoaffective disorder between 18 and 59 years of age.
      The study duration is approximately 3 months, with the rTMS sessions lasting for 4 weeks, 5
      times a week, for about 1 hour each. Several scales will be used to assess symptom severity
      as part of the clinical assessment. Cognition will be assessed using a validated battery and
      the N-back task.

      This study also involves a type of brain imaging known as magnetic resonance imaging (MRI) at
      the beginning and at the end of the 4 weeks of daily rTMS to better understand the effects of
      rTMS on brain structure and function. Investigators will measure the size and connections of
      different parts of the brain to assess brain structure and blood flow while you are
      completing some basic tasks to assess brain function. We will also collect two blood samples
      (before and after rTMS treatment) to see if certain proteins change in response to treatment.
      Finally, an analysis of genetic material will be conducted to see if genes play a role in
      differences in how people respond to treatment.
    

Intervention name(s): Repetitive Transcranial Magnetic Stimulation
Intervention type(s): Device
Intervention description(s): rTMS is a non-invasive procedure involving the use of magnetic fields to stimulate nerve cells.
Other intervention name(s): MagPro X100 Series (Medtronic A/S, Copenhagen, Denmark)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Repetitive Transcranial Magnetic Stimulation; Schizophrenia; Cognition; Working Memory
Adiponectin Polymorphisms, Insulin Resistance, and Pharmacokinetics in Obesity
Condition: Obesity
MeSH terms: Obesity; Insulin Resistance
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to determine the influence of insulin resistance on
      drug metabolism and response in obese subjects. The investigators hypothesize that expression
      of adiponectin (a hormone secreted by fat tissue), and specific variants in the adiponectin
      gene can predict the insulin resistance and drug response among obese subjects.
    

Detailed description: 
      The following study will hypothesizes that insulin resistance causes changes in drug
      metabolism, elimination, and effect. We will differentiate the insulin resistant phenotype
      amongst obese individuals on the basis of both laboratory (fasting insulin, triglycerides,
      fasting glucose) analysis, and quantitative and qualitative adiponectin expression. We will
      determine the effect of insulin resistance on the pharmacokinetics and pharmacodynamics of
      anesthetic induction agents and opioids, using propofol and fentanyl as examples.
    

Intervention name(s): Propofol and Fentanyl administration
Intervention type(s): Drug
Intervention description(s): Propofol will be administered to all patients via infusion at a dose of 2 mg/kg lean body weight/minute. The infusion will stop once loss of consciousness is reached. Fentanyl will be administered via target controlled infusion to achieve a plasma concentration of 2 ng/ml.
Other intervention name(s): anesthetic administration
Intervention MeSH terms: Fentanyl; Propofol; Anesthetics
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Obesity; Insulin Resistance
Inhaled Iloprost (Ventavis): Efficacy, Safety, and Pharmacokinetics (PK) Confirmation Study
Condition: Hypertension, Pulmonary
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is to investigate the efficacy, safety, and Pharmacokinetics (PK) of Inhaled
      Iloprost (Ventavis) therapy in Japanese pulmonary arterial hypertension (PAH) patients in
      Main Treatment Phase (12 weeks) and to investigate the safety, tolerability, and efficacy of
      longterm Inhaled Iloprost (Ventavis) therapy in Japanese PAH patients in Extension Phase.
    


Intervention name(s): Iloprost (Ventavis inhaled, BAYQ6256)
Intervention type(s): Drug
Intervention description(s): 2.5 μg or 5.0 μg BAYQ6256 per inhalation session (Inhalation session is to be conducted 6 to 9 times per day with dosing intervals of at least 2 hours.)
Intervention MeSH terms: Iloprost
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Iloprost; Inhalation; Pulmonary Hypertension; Pulmonary Artery Hypertension; Japanese Patients