bioihbjkbjnl/mcl2 huggingface dataset:
Psychological Interventions in Siblings of Children With Cancer
Condition: Cancer
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate the effectiveness of a two-session brief
      psychological intervention in siblings of pediatric cancer patients with regard to behavior
      problems and depression.
    

Detailed description: 
      Within a randomized controlled design the effects of a brief two-session psychological
      intervention (child, parents) shall be studied in 30 siblings of newly diagnosed pediatric
      cancer patients. After a baseline assessment 3-4 weeks after diagnosis participants are
      randomly assigned to an intervention or waiting list group. Both are re-assessed at 3 and 6
      months by means of standardized questionnaires assessing psychological adaptation and
      behavior. The intervention is provided to the waiting list group after the 6-month
      assessment.
    

Intervention name(s): Brief psychological intervention
Intervention type(s): Behavioral
Intervention description(s): Psychoeducation, provision of medical knowledge, coping skills training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: cancer; siblings; behavior; psychological adaptation; intervention
A Study Of Atorvastatin For The Treatment Of High Cholesterol In Patients At High Risk Of Coronary Heart Disease (CHD)
Condition: Dyslipidemias
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 4

Summary: 
      A study of the long-term (1 year) effectiveness of atorvastatin to keep patients of high
      cardiovascular risk at the LDL cholesterol goal of <115 mg/dL
    


Intervention name(s): Atorvastatin
Intervention type(s): Drug
Intervention description(s): Atorvastatin tablets at starting doses of 10, 20, 40, or 80 mg once daily. Three dose adjustments were allowed at baseline, Week 17, and Week 34. Patients who did not meet the LDL-C target at any of these time points had their doses doubled except for those who were on the 80 mg dose. Treatment was given for 52 weeks.
Intervention MeSH terms: Atorvastatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
COVID-19: Safety and Immunogenicity of a Reduced Dose of the BioNTech/Pfizer BNT162b2 Vaccine
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a randomized phase IV dose-optimization study evaluating the safety and
      immunogenicity of two doses of COVID-19 mRNA vaccines being authorized in the European Union
      since December 2020: Vaccine BNT162b2 (Comirnaty®; Pfizer-BioNTech) in healthy adults up to
      age 55 year. Immunogenicity will be measured 28 days after first and second dose, and day 180
      and day 365 after first vaccination of 20 and 30 mcg of BNT162b2. The primary outcome is the
      level of binding antibodies for RBD 28 days after the second dose.
    

Detailed description: 
      Background: Data from the dose-escalating phase 1 trials from the COVID-19 mRNA vaccines
      being authorized in the European Union since December 2020, BNT162b2 (Comirnaty®; Pfizer-
      BioNTech) indicate that for the age group 18-55 years a lower dose of the vaccine can induce
      the same immune response as the full dose.

      Method: This is a randomized multicenter phase IV dose-optimization study evaluating the
      safety and immunogenicity of demi-doses of a COVID-19 mRNA vaccine being authorized in the
      European Union since December 2020, BNT162b2 (Comirnaty®; Pfizer- BioNTech) in healthy adults
      up to age 55 year. The study will be performed in employees of Mensura EDPB at five different
      sites.

      Objectives: The primary outcome is the level of binding antibodies for RBD 28 days after the
      second dose. Secondary outcomes are safety and reactogenicity after vaccination. The
      neutralizing antibodies and the cellular immunity 28 days after second dose will be assessed.
      Humoral and cellular immunity will be measured 180 and 365 days after first dose.
    

Intervention name(s): immunogenicity after first and second dose
Intervention type(s): Diagnostic Test
Intervention description(s): Humoral and cellulair immunity after first and second dose of the different vaccines administrated.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: vaccination; Covid19; immunogenicity
A Study to Evaluate the Efficacy and Tolerability of Rizatriptan for Treatment of Acute Migraine in Children and Adolescents (MK-0462-082 AM7)
Condition: Migraine, Acute
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This Clinical Trial evaluates the Safety and Efficacy of Rizatriptan for the Acute Treatment
      of Migraine in Children and Adolescents.
    


Intervention name(s): rizatriptan; placebo; rizatriptan; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): For participants randomized to rizatriptan in Stage 1: a single 5 or 10 mg rizatriptan orally disintegrating tablet (ODT) was to be taken within 30 minutes of onset of qualifying migraine (defined as a migraine of moderate or severe intensity).
Rizatriptan dose administered was based on participant weight at Screening: those <40 kg received 5 mg tablet, those ≥40 kg received 10 mg tablet.; For participants randomized to placebo in Stage 1: a single placebo ODT was to be taken within 30 minutes of onset of qualifying migraine.; For participants randomized to rizatriptan in Stage 2 (must have taken placebo in Stage 1 and was Non-Responder [moderate or severe pain 15 minutes after dose] to be randomized at Stage 2): a single 5 or 10 mg rizatriptan ODT was to be taken approximately 15 minutes post Stage 1 dose, to treat same qualifying migraine treated in Stage 1.
Rizatriptan dose administered was based on participant weight at Screening: those <40 kg received 5 mg tablet, those ≥40 kg received 10 mg tablet.; For participants randomized to placebo in Stage 2 (must have taken placebo in Stage 1 and was Non-Responder to be randomized at Stage 2) or allocated to placebo in Stage 2 (took rizatriptan in Stage 1 and was Non-Responder): a single placebo ODT was to be taken approximately 15 minutes post Stage 1 dose, to treat same qualifying migraine treated in Stage 1.
Other intervention name(s): Maxalt; MK-0462; Maxalt; MK-0462
Intervention MeSH terms: Rizatriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Pretreatment With Estradiol Valerate
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      The present study is set up to evaluate the efficacy of a programmation by administration of
      estrogen valerate during 6 or more consecutive days. In this prospective randomised trial, we
      study the impact of administration of Progynova® during 6, 7,8 9 or 10 consecutive days
      during the luteo-follicular transition period of the menstrual cycle.
    

Detailed description: 
      See Section Interventions
    

Intervention name(s): Estradiol valerate
Intervention type(s): Drug
Intervention description(s): Experimental group: estradiol valerate (Progynova, 2x2mg per day, 2mg in the morning, 2mg in the evening), orally, during 6-10 consecutive days from day 25 of the cycle onwards.
Both groups:start rFSH (Puregon®) at a dose of 150 IU GnRH antagonist (Orgalutran®) initiation on D6 of the stimulation.
Other intervention name(s): Progynova
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: ICSI; GnRH antagonists; planning
Investigation of the Effects of Balance Coordination and Strengthening Training on Gait, Mobility and Posture in Children With Low Vision
Condition: Children With Low Vision
MeSH terms: Vision, Low
Study type: Interventional

Summary: 
      The aim of this research is to examine and evaluate the effects of balance coordination and
      strengthening training on gait, mobility and posture in children with low vision

      The hypotheses of our study:

      H1: Balance coordination and strengthening training has an effect on gait, mobility and
      posture in children with low vision.

      H2: Balance coordination and strengthening training has no effect on gait, mobility and
      posture in children with low vision.
    

Detailed description: 
      The aim of this study is to examine and evaluate the effects of balance coordination and
      strengthening training on gait, mobility and posture in children with low vision.

      A total of 22 low-vision individuals were included in the study. Individuals were randomly
      divided into two groups as Control (n=10) and Study (n=12). The treatment group received 70
      min balance (20 min), coordination (20 min) and strengthening (20 min) training 3 days a week
      for 8 weeks. No additional treatment was applied to the control group. Evaluations were
      performed before treatment and at the end of 8 weeks.

      In the evaluations; Bruininks-Oseretsky Motor Proficiency Test 2 Short Form (BOT2- KF), New
      York Posture Analysis, Manual November muscle strength assessment, G-Walk Gait Analysis,
      Independent Mobility Questionnaire (BMA) were used.
    

Intervention name(s): balance coordination and strengthening training
Intervention type(s): Other
Intervention description(s): The 25 individuals who met the inclusion criteria were divided into 2 groups, including 13 in the study group and 12 in the control group.
Study group: Low vision children were given balance, coordination training and general strengthening training with sandbags for 70 minutes 3 days a week (5-minute warm-up phase, 20-minute balance training, 20-minute coordination training, 20-minute strengthening training and 5-minute cooling phase) for 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Criteria for Inclusion of Volunteers in the Study and Control Group in the Research:
to be in the age of 7-14, Except for visual impairment (neurological and systemic diseases, hearing impairment, etc. ) not having an additional disease October, Having been diagnosed with low vision, To be able to establish cooperation, Volunteering to participate in the study The 25 individuals who met the inclusion criteria were divided into 2 groups, including 13 in the study group and 12 in the control group
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Low vision; visually impaired; balance; strength training; walking
Bayesian Estimation of Diagnostic Performance of Diabetic Cardiovascular Autonomic Neuropathy Without a Gold Standard
Condition: Diabetic Cardiovascular Autonomic Neuropathy (DCAN)
MeSH terms: Peripheral Nervous System Diseases; Nervous System Diseases
Study type: Observational

Summary: 
      This study aimed to estimate sensitivities and specificities of diabetic cardiovascular
      autonomic neuropathy (DCAN) diagnostic tests using the Bayesian approach without a gold
      standard in another independence dataset.The reference the values for the short-term HRV were
      calculated in the investigators' previous study (including 371 healthy subjects). This study
      dataset contained 200 diabetic patients who completed both the short-term HRV test and
      Ewing's test. Simultaneous inferences about the population prevalence and the performance of
      each diagnostic test were possible using the Bayesian approach without a gold standard.
    

Detailed description: 
      The CAN prevalence is rapidly growing in all populations worldwide. No document has been
      reported diagnostic performance of short-term heart rate variability (HRV) for diabetic
      cardiovascular autonomic neuropathy (DCAN) in the Chinese population. This study aimed to
      estimate sensitivities and specificities of DCAN diagnostic tests using the Bayesian
      approach, in the absence of a gold standard in another independence dataset.The reference the
      values for the short-term HRV were calculated in the investigators' previous study (including
      371 healthy subjects). This study dataset contained 200 subjects who completed both the
      short-term HRV test and Ewing's test. Simultaneous inferences about the population prevalence
      and the performance of each diagnostic test were possible using the Bayesian approach without
      a gold standard.
    

Intervention name(s): not intervention
Intervention type(s): Other
Intervention description(s): This is a cross-sectional study for estimation of diagnostic performance.
Other intervention name(s): nothing
Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Diabetic patients with inclusion and exclusion criteria were recruited from healthy
        examination centres to assess cardiovascular autonomic function using both the short-term
        heart rate variability and Ewing's tests.
      
Keywords: Bayesian estimation, short-term heart rate variability, diabetic cardiovascular autonomic neuropathy, diagnostic performance; Diagnostic performance; short-term heart rate variability; diabetic cardiovascular autonomic neuropathy; DCAN
Evaluation of 24-Hour Intragastric pH Using Esomeprazole, Lansoprazole, and Pantoprazole in Hispanic Patients With GERD
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will be conducted in order to determine safety and efficacy esomeprazole,
      lansoprazole and pantoprazole control stomach acid by measuring the stomach acid in men and
      women of Hispanic origin who have GERD.
    


Intervention name(s): Esomeprazole 40mg; Pantoprazole 40mg; Lansoprazole 30mg
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Esomeprazole; Pantoprazole; Lansoprazole; Dexlansoprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GERD; acid reflux; heartburn; PPI; Hispanic
Evaluation of 18F-DCFBC PSMA-based PET Imaging for Detection of Metastatic Prostate Cancer
Condition: Metastatic Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This research is being done to see if an investigational radioactive drug called 18F-DCFBC
      can help us find cancer that has spread (metastatic disease) from its original site in people
      who have cancer in their prostate to other parts of their body.
    

Detailed description: 
      The objective of this study is to evaluate a radiolabeled urea-based small molecule inhibitor
      of prostate-specific membrane antigen (PSMA), [18F]DCFBC (DCFBC) PET imaging for detection of
      metastatic prostate cancer. PSMA is a well characterized histological marker of prostate
      cancer tumor aggressiveness and metastatic potential. The investigators propose to assess the
      ability of DCFBC PET to detect metastatic prostate cancer by visual qualitative and
      quantitative SUV analysis. Correlation will be made to sites of suspected metastatic disease
      detected by standard conventional imaging modalities (CIM) for prostate cancer which includes
      IV contrast CT of chest/abdomen/pelvis and whole body bone scintigraphy.
    

Intervention name(s): 18F-DCFBC
Intervention type(s): Drug
Intervention description(s): 18F-DCFBC is a radiofluorinated small-molecule inhibitor of prostate-specific membrane antigen (PSMA).
A bolus of 10 mCi (370 MBq) [9-11 mCi (333-407 MBq)] of 18F-DCFBC will be injected into the IV line by slow IV push.
Other intervention name(s): N-[N-[(S)-1,3-dicarboxypropyl]carbamoyl]-4-18F-fluorobenzyl-L-cysteine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Metastatic Prostate Cancer
Nifedipine (Adalat CR, BAY A1040) High Dose PK/PD Study
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-center, randomized, double-blind, 6 x 3 cross-over study. All patients who
      meet the entry criteria will be required to stop taking any other anti-hypertensive agents
      than Adalat CR (controlled release), if taken, before starting 4 weeks (±7days) open-label
      Adalat CR 40 mg once daily (OD) treatment phase (baseline treatment period). Of them, those
      who are confirmed with their eligibility as subjects for the present study at the end of the
      baseline treatment period will be randomly allocated to one of the 6 treatment sequences on
      the basis of a computer-generated randomization list. Subsequently, BAY A1040 CR tablet 40 mg
      OD, 40 mg twice daily (BID) or 80 mg OD will be administered to a total of 6 weeks, 2 weeks
      per each treatment period (Period 1-3) under double-blind conditions using BAY A1040 CR
      tablet 40 mg and its placebo as follows (Double-blind treatment period).
    

Detailed description: 
      Issues on safety are addressed in the Adverse Event section.
    

Intervention name(s): Nifedipine (Adalat CR, BAYA1040) 80mg OD; Nifedipine (Adalat CR, BAYA1040) 40mg BID; Nifedipine (Adalat CR, BAYA1040) 40mg OD
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Nifedipine (Adalat CR, BAYA1040) 80 milligram (mg) once daily (OD) in the morning; Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) twice daily (BID). 40 mg in the morning and 40 mg in the evening; Nifedipine (Adalat CR, BAYA1040) 40 milligram (mg) once daily (OD) in the morning
Intervention MeSH terms: Nifedipine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Fibrate Therapy in Two Patients With Neutral Lipid Storage Disease With Myopathy (NLSDM)
Condition: Neutral Lipid Storage Disease
MeSH terms: Muscular Diseases; Lipidoses; Lipid Metabolism, Inborn Errors; Ichthyosiform Erythroderma, Congenital; Metabolic Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Neutral Lipid Storage Disease With Myopath (NLSDM) is a disease caused by a defect in the
      PNPLA2 gene encoding ATGL. Patients with NLSDM accumulate triglycerides and exhibit muscle
      weakness, cardiac failure and hepatosteatosis. Most of these patients die at young age due to
      cardiac failure. Not much is known about the underlying mechanisms, though recently it was
      discovered that PPAR activation in ATGL-/- mice was impaired leading to decreased
      mitochondrial function, lipid accumulation and cardiac failure resulting in death at young
      age. Activation of PPARs, by treatment with fibrates rescued the phenotype and reduced
      mortality rates in these mice. These findings may have a major impact for patients with NLSDM
      if these results can be translated to humans. Therefore, the investigators would like to
      evaluate the beneficial effects of fibrate treatment on muscle mitochondrial and cardiac
      function in patients with NLSDM.

      Patients will be treated with fibrates during a period of 28 weeks. Baseline measurements
      will be performed prior to the study and after treatment. Cardiac and muscular lipid
      accumulation, cardiac function, mitochondrial function and insulin sensitivity will be
      assessed during these baseline measurements.
    


Intervention name(s): Fibrate treatment
Intervention type(s): Drug
Intervention description(s): Patients will receive a dosage of 400mg Bezafibrate every day during 28 weeks
Intervention MeSH terms: Clofibric Acid
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NLSDM; Lipid accumulation
Transcranial Pulse Stimulation (TPS) for Alzheimer's Disease (AD)
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      This is a prospective open comprehensive proof-of-principle pilot study.
    

Detailed description: 
      This is a prospective open comprehensive proof-of-principle pilot study with patients of mild
      to moderate Alzheimer's Disease who have been treated with transcranial pulse stimulation
      (TPS)
    

Intervention name(s): NEUROLITH
Intervention type(s): Device
Intervention description(s): transcranial pulse stimulation (TPS)
Other intervention name(s): transcranial pulse stimulation (TPS)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Tacrolimus Combined With Prednisone Treatment of Idiopathic Membranous Nephropathy and Nephrotic Syndrome
Condition: Idiopathic Membranous Nephropathy; Nephrotic Syndrome
MeSH terms: Kidney Diseases; Nephrotic Syndrome; Nephrosis; Glomerulonephritis, Membranous; Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Idiopathic membranous nephropathy (IMN) is one of the most common forms of nephrotic syndrome
      (NS) in adults and is usually treated by corticosteroids in combination with cytotoxic drugs
      especially cyclophosphamide or cyclosporine. Tacrolimus, a new immunosuppressive agent, was
      proved to be effective in treating refractory NS. Whether it is effective in IMN has not been
      reported. We therefore undertook a multi-center, controlled study to investigate the efficacy
      and safety profile of tacrolimus compared with cyclophosphamide in the treatment of patients
      with idiopathic membranous nephropathy and nephrotic syndrome.
    

Detailed description: 
      Idiopathic membranous nephropathy (IMN) is one of the most common forms of nephrotic syndrome
      (NS) in adults and is usually treated by corticosteroids in combination with cytotoxic drugs
      especially cyclophosphamide or cyclosporine. However, the effect was not satisfying and the
      side-effects of the above immunosuppressive agents were often a worrying problem. Tacrolimus,
      a new immunosuppressive agent, was proved to be effective in treating refractory NS
      especially FSGS. Whether it is effective in IMN has not been reported. We therefore undertook
      a multi-center, controlled study to investigate the efficacy and safety profile of tacrolimus
      compared with cyclophosphamide in the treatment of patients with idiopathic membranous
      nephropathy and nephrotic syndrome.
    

Intervention name(s): tacrolimus combined with prednisone
Intervention type(s): Drug
Intervention MeSH terms: Prednisone; Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Allopurinol Combination Study
Condition: Gout
MeSH terms: Gout
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare the proportion of subjects whose serum urate (sUA) levels are < 6.0 mg/dL
      following 4 weeks of continuous treatment of RDEA594 in combination with allopurinol to
      allopurinol alone in subjects with documented inadequate hypouricemic response with standard
      doses of allopurinol.
    


Intervention name(s): RDEA594; Placebo; Allopurinol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Uricosuric agent for the treatment of gout.; Matching Placebo; Allopurinol
Intervention MeSH terms: Allopurinol; Lesinurad
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment