bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Respiratory Muscle Training on Postoperative Pulmonary Complications of Cardiac Surgery
Condition: Heart Diseases; Coronary Disease; Cardiovascular Diseases; Coronary Artery Occlusion
MeSH terms: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Coronary Occlusion
Study type: Interventional

Summary: 
      This study will evaluate the profilatic effects of inspiratory muscle training (IMT) on
      functional capacity, respiratory muscle strength, postoperative pulmonary complications and
      days of hospitalization (PPC) in patients submitted to coronary artery bypass graft surgery
      (CABG).
    

Detailed description: 
      Patients undergoing coronary artery bypass graft surgery are at risk of postoperative
      pulmonary complications, which lead to increased postoperative morbidity and mortality.

      A few studies have demonstrated that preoperative physical therapy has advantages over
      postoperative care in patients undergoing cardiac . In this way, this study aim to
      investigate the effects of preoperativeinspiratory muscle training in patients at high risk
      of postoperative pulmonary complications who were scheduled for coronary artery bypass graft
      surgery.
    

Intervention name(s): Inspiratory Muscle Training
Intervention type(s): Other
Intervention description(s): The inspiratory muscle training (IMT) will be carried out in the IG with Threshold® IMT (Respironics New Jersey, Inc) consisting of a unidirectional flow control valve which assures the constant resistance (linear load) between 7 and 41cmH20.
The IMT will be carried out in the sitting position with a load of 30% of the MIP during the two weeks preceding the surgery, seven days a week, twice daily in three series of ten repetitions with a 30 second interval between series, under the supervision of a physiotherapist. A load of 15% of the MIP was used only on the first day of training in order for the individual to adapt to the equipment. Subsequently, the 30% MIP load will be applied and readjusted according to the new MIP values determined every four days.
Other intervention name(s): Respiratory Muscle Training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Double-Dose Safety Study of An Influenza Vaccine (Multimeric-001) Injected to Elderly Volunteers
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a phase I/II, randomized, single-blind, placebo-controlled escalating double-dose
      study of the safety and priming potential of an intramuscular Influenza vaccine
      (Multimeric-001) injected to elderly volunteers.
    

Detailed description: 
      This is a Phase I/II single-center, randomized, placebo-controlled, single-blind,
      dose-escalation, double-dose administration study comprising two dosing cohorts (Cohort 1:
      250 mcg M-001 per injection and Cohort 2: 500 mcg M-001 per injection) with 20 subjects in
      each cohort receiving either adjuvanted or non-adjuvanted formulations. The adjuvant used was
      Montanide ISA VG51. Cohort 3 with 20 subjects was administered placebo. After priming with
      M-001 or placebo, all participants were administered a boost of a conventional trivalent
      vaccine on day 42.

      There was a minimum of 10 days interval between last dosing of the first injection to the
      last subject of the 250 μg cohort (Cohort 1) and first dosing of the first subject injection
      with 500 µg cohort (Cohort 2).

      For each subject, the second injection was performed 21+2 days after his/her first injection,
      provided they were deemed fit to be dosed by a study physician.

      The DSMB reviewed the safety data obtained from cohorts 1 and 2 before approving their second
      injection and before dose escalation.
    

Intervention name(s): Multimeric-001 250 mcg; Adjuvanted Multimeric-001 250mcg; Placebo; Adjuvant: Montonide isa 51 VG; Multimeric-001 500 mcg; Adjuvanted Multimeric-001 500mcg; TIV
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Multimeric-001 (M-001) was administered twice at a dose of 250mcg via the IM route to 10 participants as a primer, followed by TIV boost immunization. in 19-23 days interval between them.; Injection of Multimeric-001 250 mcg with Adjuvant Montonide isa 51 VG, 2 doses with interval of 19-23 days between them; Placebo injected with PBS (Phosphate Buffered Saline), 2 injections with the interval of 19-23 days between them.; Injection of Placebo with Adjuvant Montonide isa 51 VG, 2 injections with the interval of 19-23 days between them.; Injection of Multimeric-001 with PBS, 2 injections with the interval of 19-23 days between them.; Injection of Multimeric-001 500 mcg with Adjuvant Montonide isa 51 VG, 2 doses with the interval of 19-23 days between them; Injection of the conventional flu vaccine: Vaxigrip to all study participants.
Other intervention name(s): Vaxigrip
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Multimeric; Vaccine; Influenza; elderly; phase 1/2; safety; efficacy; tolerability; reactogenicity; Montanide; hemagglutinin inhibition; HAI; TIV
Laboratory Study of Lymphoblasts in Young Patients With High-Risk Acute Lymphoblastic Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Observational

Summary: 
      RATIONALE: Collecting and storing samples of bone marrow and blood from patients with cancer
      to study in the laboratory may help doctors learn more about changes that may occur in DNA
      and identify biomarkers related to cancer.

      PURPOSE: This laboratory study is looking at lymphoblasts in young patients with high-risk
      acute lymphoblastic leukemia.
    

Detailed description: 
      OBJECTIVES:

        -  Identify regions of copy number abnormalities (CNA) and uniparental disomy in leukemic
           lymphoblasts from pediatric patients with high-risk acute lymphoblastic leukemia (ALL)
           using Affymetrix GeneChip Mapping 500K array sets. (Pilot project)

        -  Identify regions of CNA and loss-of-heterozygosity using Affymetrix SNP 6.0 microarrays.
           (Expansion project)

        -  Define gene expression profiles for leukemic lymphoblasts using Affymetrix U133 Plus 2.0
           arrays.

        -  Assess the global expression of microRNAs in leukemic lymphoblasts using microRNA gene
           chips.

        -  Utilize array-generated gene expression data and data for CNAs and uniparental disomy to
           prioritize candidate genes and genomic regions for resequencing.

        -  Characterize epigenomic profiles using the HpaII tiny fragment Enrichment by
           Ligation-mediated PCR (HELP) assay. (Expansion project)

        -  Discover candidate therapeutic targets for these patients by identifying genes that are
           consistently mutated in leukemic lymphoblasts using high-throughput focused gene
           resequencing. (Pilot project)

        -  Discover candidate therapeutic targets for these patients by next generation sequencing
           technologies, including whole genome, whole transcriptome, and whole exome. (Expansion
           project)

      OUTLINE: This is a multicenter study.

      Banked biological samples (bone marrow and peripheral blood) are analyzed using gene
      expression profiling, single-nucleotide polymorphism and genotyping assays, DNA copy number
      and loss of heterozygosity estimates, epigenetic profiling, and gene resequencing.

      PROJECTED ACCRUAL: A total of 150 patient samples will be accrued for this study.
    

Intervention name(s): loss of heterozygosity analysis; microarray analysis; polymorphism analysis; tumor replication error analysis
Intervention type(s): Genetic; Genetic; Genetic; Genetic
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Targets for High-Risk Pediatric Acute Lymphoblastic Leukemia
      
Keywords: childhood acute lymphoblastic leukemia in remission; B-cell childhood acute lymphoblastic leukemia
Adults Nutrition as a Protective or Health-risk Factor
Condition: Nutritional Status; Nutrient Deficiency; Micronutrient Deficiency; Vitamin D Deficiency; Vitamin B 12 Deficiency; Folic Acid Deficiency; Iron-deficiency; Thyroid Diseases; Diet
MeSH terms: Iron Deficiencies; Vitamin D Deficiency; Vitamin B 12 Deficiency; Folic Acid Deficiency; Thyroid Diseases
Study type: Observational

Summary: 
      To obtain up-to-date data on nutrient intakes in adults, a national dietary survey - the EU
      Menu study will be conducted during 12 consecutive months in 2017/2018, providing data on the
      consumption of foods and enabling the assessment of energy and macronutrient intakes.
      Participating subjects will be invited to NUTRIHEALTH study for assessment for micronutrient
      status (focusing into vitamin D, folic acid, vitamin B12, and iron) and medical examination,
      in which thyroid size will be aslo measured, to investigated thyroid epidemiology in
      Slovenia.
    


Intervention name(s): Assessement of nutritional status; Thyroid size
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Nutritional status for vitamin D, folic acid, vitamin B12 and iron.; Thyroid size by ultrasound.
Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        This observational study is conducted on randomly selected residents of Republic of
        Slovenia. The EU Menu study (LOT2) include a minimum of 1.133 of habitants from Slovenia in
        the age 18-74 years. In line with the EU Menu methodology and to ensure representativeness
        of the sample, participants will be randomly selected from the Slovenian population using
        Central Population Register (selection outsourced by the Statistical Office of Republic of
        Slovenia ), and visited on their home. After completion of the EU Menu Survey
        (questionnaires on self-reported health status and food intake), participants will be
        invited to collaborate in the proposed study.
      
Biospecimen description: 
      Blood samples will be freezed for possible further analyses on markers related with nutrition
      & health
    
Keywords: dietary intake; nutritional status; micronutrients; thyroid health
Female Urogenital Nutrition- Health Study
Condition: Bacterial Urinary Tract Infection
MeSH terms: Urinary Tract Infections
Study type: Interventional

Summary: 
      The purpose of this study is to assess nutrition and urinary tract bacterial activity during
      menstruation of approximately 15 female university Reserve Officer Training Corps (ROTC)
      cadets and Phoenix area police officers, firefighters, and military veterans.
    

Detailed description: 
      Urinary tract infections (UTIs) disrupt tactical service women's obligations and health,
      which increases sexual transmitted infections (STIs), HPV, and cervical cancer risk if left
      untreated. Females are more susceptible to UTIs due to their unique anatomical features and
      hormone fluctuations affecting vaginal flora. During phase 1 of the menstrual cycle (i.e.,
      onset of bleeding, menstrual cycle days 1-5), estrogen levels significantly decrease and
      inhibit the growth of lactobacilli (good bacteria), which is essential in warding off bad
      bacteria and infections, particularly UTIs. The uropathogenic bacterial growth in phase 1
      could be heightened in phase 2 of the menstrual cycle (i.e., leading to ovulation), as
      increases in estrogen favors bacteria adhesion and arginine vasopressin (AVP) release that
      stimulates fluid retention, leading to less volume flow in the urinary tract. To reduce UTI
      onset, it is recommended to frequently urinate with sufficient urine void volume to
      facilitate washing out harmful bacteria from the urethra and bladder. While menstruating,
      increased fluid consumption to support urination frequency and void volume may be critical,
      as the urinary tract is more predisposed to infections, and the effects of estrogen on
      bacterial adhesion and AVP release in phase 2 could continue uropathogenic growth.

      Question(s) 1: Are premenopausal tactical service women's current hydration status and
      behaviors (i.e., fluid intake and urination) sufficient? How many premenopausal tactical
      service women have a UTI history?

      Question 2: Will increasing daily water intake of identified underhydrated tactical service
      women reduce uropathogenic bacterial activity during the first part (i.e., onset of bleeding
      through day 5) of the menstrual cycle?
    

Intervention name(s): Plain Water
Intervention type(s): Other
Intervention description(s): To increase water fluid intake, an additional 1.89 L, during phase 1 of the menstrual cycle (days 1-5).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Safety, Efficacy and Cost-effectiveness of Racecadotril in Children With Acute Diarrhea in Mexico
Condition: Diarrhea
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      Rationale: Acute diarrhea (AD) is still a significant morbidity-mortality problem worldwide.
      Although oral rehydration therapy is the cornerstone, its anti-diarrheal effect is a
      controversial subject. Since ten years ago, Racecadotrilo´s safety and efficacy had been
      proved. However, a pharmacoeconomics analysis on this therapeutics has not been published
      yet.

      Objective: Evaluate the efficacy, safety, tolerability and costs associated with Racecadotril
      administration in comparison to a placebo in infants up to 24 months of age with AD in a
      hospital (mildly or moderately dehydrated) and ambulatory (no dehydrated) settings at the
      National Institute of Pediatrics in Mexico.

      Material and Methods: Randomized, double-blind, placebo controlled, clinical trial (RDBCCT)
      with pharmacoeconomics analysis (cost minimization) to realize in 454 infants with AD (270
      hospitalized and 184 outpatients), 1 to 24 months of age who concomitantly will receive ORT
      and Racecadotril (1.5mg./Kg./t.i.d. doe 5 days) (ORT-Rac Group) or placebo (ORT-Placebo
      Group). The clinical outcomes in the hospitalized infants to measure will be a) Stool output
      rate at 48hs. and at the end of the study; b) duration of diarrhea; c) percentage of
      intravenous (IV) needs and d) percentage of adverse events. The outcome variables in
      outpatient infants to measure will be a) total liquid and semi-liquid bowel movements during
      the study; b) duration of diarrhea and c) percentage of adverse events. The pharmacoeconomics
      analysis will involve a cost minimization analysis (CMA). Results will be analyzed through bi
      and multivariate analysis using STATA 11.0 for Mac, considering a p value < 0.05 as
      significant. The pharmacoeconomics model will made through decisions trees using TreAge Pro
      Healthcare v 1.2.0, 2009.
    


Intervention name(s): Racecadotril; Placebo groups
Intervention type(s): Drug; Drug
Intervention description(s): oral racecadotril (1.5mg./Kg./t.i.d. doe 5 days) in double blind assigned.; Placebo with feature color, appearance and tase similar to racecadotril t.i.d. for 5 days
Intervention MeSH terms: Racecadotril
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acute diarrhea; Acute diarrhea (three or more watery or semi-watery bowel movements for at least one day lasting no more than 5 days before being admitted)
Safinamide Steady State Interaction With Rosuvastatin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate if safinamide at the steady state, obtained after multiple 100 mg once a day
      administrations, has an effect on the pharmacokinetics of rosuvastatin, concomitantly
      administered as a single 20 mg dose, with respect to the pharmacokinetics of 20 mg
      rosuvastatin administered alone.
    

Detailed description: 
      Xadago® SmPC reports that safinamide may transiently inhibit BCRP, therefore a time interval
      of 5 h should be kept between dosing of safinamide and medicinal products that are BCRP
      substrates with a Tmax ≤ 2 h (e.g. pitavastatin, pravastatin, ciprofloxacin, methotrexate,
      topotecan, diclofenac or glyburide).

      Following a specific request of FDA, the present interaction study in healthy male and female
      volunteers will be conducted in order to determine if multiple dose administration of
      safinamide with the BCRP substrate rosuvastatin alters the plasma exposure of rosuvastatin in
      vivo. Orally administered rosuvastatin, a 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA)
      reductase inhibitor, developed for the treatment of dyslipidaemia, represents a sensitive
      probe to assess the magnitude of BCRP inhibition. In PK trials in healthy volunteers,
      rosuvastatin Tmax ranged from 1.7 to 5 h after administration of 10-80 mg doses.
    

Intervention name(s): 100 mg safinamide; 20 mg rosuvastatin calcium period 1; 20 mg rosuvastatin calcium period 2
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Safinamide will be administered as follows:
Days 5-11: 100 mg safinamide (one Xadago® tablet), once a day
Day 12: a single dose of 100 mg safinamide (one Xadago® tablet), immediately followed by a single dose of 20 mg rosuvastatin calcium (one Crestor® tablet)
Days 13-15: 100 mg safinamide (one Xadago® tablet) once a day The medication will be orally administered in the morning, at 8:00±1h, under fasting conditions, with 240 mL (total volume) of still mineral water.; Rosuvastatin will be administered as follows:
- Day 1: a single dose of 20 mg rosuvastatin calcium (one Crestor® tablet); - Day 12: a single dose of 20 mg rosuvastatin calcium (one Crestor® tablet) immediately after the safinamide administration
Other intervention name(s): Xadago®; Crestor®; Crestor®
Intervention MeSH terms: Calcium, Dietary; Rosuvastatin Calcium; Calcium
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Leflunomide in Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      Study objectives:

        -  To provide more insight on the modulation of inflammation and matrix degrading factors
           in serum and urine by leflunomide in early , active patients with RA and to validate the
           sensitivity of DEMRI (Dynamic Enhanced Magnetic Resonance Imaging) in detecting
           inflammatory changes in active RA in response to treatment with leflunomide

        -  Effect of leflunomide therapy on physical function improvement and Quality of life
    


Intervention name(s): Leflunomide
Intervention type(s): Drug
Intervention MeSH terms: Leflunomide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase 2 Study of Nimotuzumab in Pediatric Recurrent Diffuse Intrinsic Pontine Glioma
Condition: Recurrent Diffuse Pontine Gliomas
MeSH terms: Glioma; Diffuse Intrinsic Pontine Glioma; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase 2, single-arm, multi-center study, with a safety review component, designed
      to evaluate the efficacy and safety of nimotuzumab in approximately 44 patients with
      recurrent diffuse intrinsic pontine glioma (DIPG) following one previous regimen for their
      disease. Patients must be diagnosed with radiologically verified recurrent diffuse intrinsic
      pontine glioma that is measurable in at least two dimensions. Patients are eligible without
      histologic confirmation. Treatment regimen will consist of two phases-induction and
      consolidation.
    


Intervention name(s): nimotuzumab (anti EGFR humanized monoclonal antibody)
Intervention type(s): Biological
Intervention description(s): 150 mg/m2 I.V. Induction phase: infusions once a week for 8 weeks. Consolidation phase: infusions once every 2 weeks for 10 weeks. Patients may then continue on the consolidation regimen of nimotuzumab, until disease progression or the occurrence of unacceptable toxicity.
Intervention MeSH terms: Nimotuzumab; Antibodies; Antibodies, Monoclonal
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diffuse intrinsic pontine glioma; Common Terminology Criteria; Epidermal Growth factor receptor; Human antihuman antibody; pharmacokinetics; monoclonal antibody; Informed Consent Form
Misoprostol for Second Trimester Termination of Pregnancy
Condition: Termination of Pregnancy Second Trimester
Study type: Interventional

Summary: 
      To compare the efficacy of two different dose regimens of misoprostol administered vaginally
      in combination with mifepristone in second trimester termination of (non)viable pregnancy.
    

Detailed description: 
      The study was designed as a prospective double blinded randomised controlled trial, comparing
      200µg to 400 µg misoprostol given vaginally at four hour intervals, starting 36-48 hours
      after the oral administration of mifepristone 200 mg at a gestational age between 14 to 24
      weeks.
    

Intervention name(s): misoprostol; misoprostol
Intervention type(s): Drug; Drug
Intervention description(s): mifepristone 200 mg followed by 200 µg misoprostol per vaginam 36- 48 hours later at 4 hourly intervals (with a maximum of 10 administrations in 48 hours) until the foetus was delivered.; mifepristone 200 mg followed by 400 µg misoprostol per vaginam 36- 48 hours later at 4 hourly intervals (with a maximum of 10 administrations in 48 hours) until the foetus was delivered.
Other intervention name(s): migegyne; cytotec; mifegyne; cytotec
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: misoprostol; mifepristone; medical abortion; randomised controlled trial