bioihbjkbjnl/mcl2 huggingface dataset:
Oral Vitamin A Supplementation in Neonates With Birth Weight < 1500 g
Condition: Bronchopulmonary Dysplasia; Retinopathy of Prematurity
MeSH terms: Bronchopulmonary Dysplasia; Retinal Diseases; Retinopathy of Prematurity; Premature Birth; Birth Weight
Study type: Interventional

Summary: 
      Vitamin A is essential for optimal growth, and development. In the newborn, especially if
      preterm, it is necessary for the cellular differentiation, for the health of the anterior
      eye, it is a constituent of visual pigment, and it is essential for surfactant synthesis.
      Immune response Vitamin A supplementation demonstrated to reduces infancy mortality, but very
      low (<1500g birth weight) and extremely low (<1000g birth weight) preterm infants are born
      with low body stores of vitamin A and are at high risk of vitamin A deficiency. Nevertheless,
      optimal vitamin A supplementation for these infants is not clearly defined, despite evidence
      of benefit of an early supplementation.

      Prematurity is associate to the risk for bronchopulmonary dysplasia (BPD) which is a disease
      marked by respiratory compromise associated with high mortality and severe long-term
      morbidity, as well as prematurity is associate to the risk for retinopathy, a pathology that
      may be related to less rhodopsin quantity which seem dependent on vitamin A concentration.
      Vitamin A can be given enterally, intramuscularly, or intravenously. Recently an oral
      administration as drops is available resulting particularly convenient avoiding the pain
      associated with repetitive intramuscular injections, or the discomfort of parenteral
      administration. Studies of vitamin A in the infant population suggest that plasma retinol
      concentrations >0.7 µM/L indicate vitamin A sufficiency, nevertheless preterm infants have
      lower concentration and concentration < 0.35 µM/L are very dangerous. Vitamin A deficiency at
      this level may constitute a problem for preterm newborn, resulting for example, in
      histological alterations in the respiratory epithelium leading to chronic lung disease,
      retinopathy of prematurity, patency of the ductus arteriosis, and immune competence
      deficiency.

      The aim of the present study is to verify efficacy and tolerability of a new oral
      administration of vitamin A as drops, 3000 IU/kg/die for 4 weeks, in infants < 1500g weight
      at birth, verifying the competence of the supplementation reaching ideal blood concentration
      (≥0.7 µM/L) and relating the blood achieved concentrations of vitamin A to the outcome in
      typical pathologies, as BPD and ROP. Not treated group of matched newborn infants is the
      controlarm.
    


Intervention name(s): Vitamin A oral drops
Intervention type(s): Dietary Supplement
Other intervention name(s): VISPO, BIOTRADING Pharma
Intervention MeSH terms: Vitamin A
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: VITAMIN A; BLOOD CONCENTRATION; retinopathy of prematurity
Hydration During Thoracic Surgery
Condition: Hospital Length of Stay; Adverse Events
Study type: Observational

Summary: 
      The purpose of this retrospective study was to analyze the role of intraoperative crystalloid
      administration on postoperative hospital length of stay and on the incidence of previously
      reported adverse events following thoracic surgery.
    

Detailed description: 
      The role of intraoperative crystalloid administration, when expressed as dose-response
      curves, on the duration of hospital length of stay (hLOS) and on previously reported
      incidences of surgical, cardiovascular, pulmonary, renal, other, and long-term AEs was
      evaluated with F-ratio statistics or with Chi-square tests set at a more stringent P<.01
      value for significance to reduce the incidence of false discovery rates. Loglinear variance
      was utilized to examine the role of postoperative hLOS residuals across the range of
      intraoperative crystalloid administration. Multivariable analysis screened those previously
      reported independent variables with P<.1 with length of surgery, and the a posteriori
      variable of interest, rate of intraoperative crystalloid administration on duration of hLOS
      in a stepwise fashion with a maximum 5-fold R2 stopping rule, a cross validation technique
      that chooses the best model. The multivariable analysis was repeated with a regional
      instrumental variable based upon state residency to represent unmeasured confounders in this
      population that may have an association with the outcome of interest. Variance inflation
      factors calculations were conducted to determine the role of multicollinearity by the
      independent variables of interest. Sample size calculations for multivariable analysis
      require a minimum of 100 patients with ≥200 the preferred sample size. Recursive partitioning
      with 5-fold cross-validation, a measure of internal model validation, examined administration
      rates of intraoperative crystalloid administration by quantiles on hLOS and the role of
      intraoperative transfusion of pRBCs on hLOS. Tests to support the likelihood of causality of
      the intraoperative crystalloid administration on duration of hLOS was examined following
      analysis of seven likelihood tests; published findings consistent with prior research,
      biologic plausibility, dose-response relationship, strength of effect, and exclusions of
      effect-cause, confounding, and bias. The statistical program, JMP 13.2 (SAS Institute, Cary,
      NC) was utilized in this study.
    

Intervention name(s): Intravenous Solution
Intervention type(s): Drug
Intervention description(s): Intraoperative hydration
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All patients 18 years of age or older who required thoracic surgery.
Bioequivalence Study of Cyclosporine 100mg Capsule Under Fasting Condition
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      To demonstrate bioequivalence between Test Product (A):Cyclosporine Soft Gelatin Capsules
      Modified 100 mg manufactured by Panacea Biotec Ltd, India and the corresponding Reference
      Product (B):Neoral (Cyclosporine capsules,USP)Modified 100mg manufactured by Novartis
      Pharmaceuticals Corporation, New Jersey, in 36 healthy adult male subjects under fasting
      condition.
    

Detailed description: 
      Total 36 normal healthy adult male subjects will be enrolled in the study. Subjects will be
      administered either the Test or the Reference Product with 240 mL of water in each period as
      per the randomization schedule. Subjects will fast for at least 10 hours prior to dose
      administration and for at least 4 hours post dose. Standardized meals will be provided in
      each study period. Water will not be accessible to the subjects 1 hour Predose and 2 hours
      Post dose in each period. A total of 24 blood samples will be withdrawn for pharmacokinetic
      profiling. The whole blood concentrations of Cyclosporine will be measured by a validated
      LC/MS/MS analytical method. Ratio analysis will be performed for untransformed and log
      transformed pharmacokinetic parameters Cmax, AUC0-72, AUC0 inf. ANOVA will be performed on
      log transformed pharmacokinetic parameters Cmax, AUC0-72, AUC0-inf and 90% confidence
      interval will be constructed for the ratio of geometric least square mean of the Test and
      Reference products, obtained from the log-transformed data. Bioequivalence will be concluded
      if the ratio estimate as well as its 90% confidence interval, both falls within the
      acceptable range of 80.00% to 125.00% for Cmax, AUC0-72 and AUC0-inf.
    

Intervention name(s): Cyclosporine Capsules USP (Modified) 100 mg
Intervention type(s): Drug
Intervention description(s): Subjects will be administered either Test Product or Reference Product with 240ml of water according to randomization schedule
Other intervention name(s): Cyclosporine Capsule; Gengraf Capsule; Sandimmune Capsule
Intervention MeSH terms: Cyclosporine; Cyclosporins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence study in healthy volunteers
Eating Disorders: Online Self-help & Usual Treatment (TAU) vs TAU Only
Condition: Anorexia Nervosa; Bulimia Nervosa; Binge Eating Disorder; Other Specified Feeding or Eating Disorder
MeSH terms: Anorexia; Bulimia; Feeding and Eating Disorders; Anorexia Nervosa; Binge-Eating Disorder; Bulimia Nervosa
Study type: Interventional

Summary: 
      A pilot study exploring whether individuals receiving usual treatment (CBT) from the
      specialist NHS Tayside Eating Disorders Service and accessing the online self-help "Smart
      Eating" programme have improved treatment outcomes compared to those receiving usual
      treatment only. The study will also explore acceptability of the "Smart Eating" self-help
      programme via a feedback questionnaire.
    

Detailed description: 
      This controlled-comparison pilot study will explore whether individuals receiving usual
      treatment (CBT) from the specialist NHS Tayside Eating Disorders Service and accessing the
      online self-help "Smart Eating" programme have improved treatment outcomes compared to those
      receiving usual treatment only. All participants would be involved in the trial for 6 months,
      capturing their motivation for change, eating disorder psychopathology and quality of life at
      four time-points (pre-treatment, mid-treatment, end of treatment, 3-month follow-up). Some
      participants may continue to receive usual treatment after study end, which will be detailed
      in the study analysis. Following trial completion, all participants will be able to access
      the "Smart Eating" programme. The study will also explore acceptability of the "Smart Eating"
      self-help programme via a feedback questionnaire to inform programme adaptations and a
      possible pragmatic randomised controlled trial planned for the future. Currently, no other UK
      study is piloting the use of the "Smart Eating" programme as an adjunct to specialist NHS
      eating disorder treatment.
    

Intervention name(s): "Smart Eating" internet-based self-help programme
Intervention type(s): Behavioral
Intervention description(s): An internet-based self-help programme using cognitive behavioural therapy principles to treat individuals receiving input from a specialist eating disorders service. The programme takes 3 months to complete.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Interleukin-1β (rs 1143627 T/C) Gene Polymorphism May Increase the Risk of Developing LDD in Turkish Population
Condition: Lumbar Disc Degeneration; Low Back Pain; Inflammation
MeSH terms: Intervertebral Disc Degeneration; Inflammation; Back Pain; Low Back Pain
Study type: Observational

Summary: 
      This study aims to show the association between the Interleukin-1β (rs 1143627 T/C) gene
      polymorphism and the patient's pain level, radiological features, functional disability, and
      spinal flexibility.
    

Detailed description: 
      Background: Lumbar disc degeneration (LDD), a complex process characterized by phenotypic and
      genotypic changes, causes low back pain.

      Aims: This study aims to show the association between the Interleukin-1β (rs 1143627 T/C)
      gene polymorphism and the patient's pain level, radiological features, functional disability,
      and spinal flexibility.

      Method: A hospital-based case-control study included 50 LDD patients and 44 healthy controls.
      In this study, Taqman allelic discrimination analysis was performed for the genotype of the
      Interleukin-1β (rs 1143627 T/C) gene polymorphism. Differences in Interleukin-1β allele
      frequencies and genotypes were evaluated between patients and controls. Relationships between
      allele presence/genotype and disease risk are reported as odds ratios (ORs) with 95%
      confidence intervals (CIs). The Pfirrmann classification was used to grade the level of disc
      degeneration on MRI scans, and the McNab's classification was used to classify disc
      displacements. The pain levels of the patient group were evaluated with VAS and their
      functional disability with ODI. Spinal flexibility was evaluated using the Modified Schober
      method and a digital inclinometer.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study was conducted between April and November 2019. This is a two-centre study
        undertaken at Yeditepe University Hospital's Department of Neurosurgery and the Yeditepe
        Institute of Health Sciences Department of Molecular Medicine. One of the analytical
        research approaches used was a case/control study.
      
Biospecimen description: 
      Interleukin 1-β (rs 1143627 T/C) Gene Polymorphism
    
Keywords: lumbar disc degeneration; polymorphism; interleukin 1 beta; low back pain
Efficacy And Safety Study Of Atorvastatin Versus Simvastatin In Type 2 Diabetic Subjects With Hypercholesterolemia
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy of Atorvastin vs Simvastatin in
      decreasing LDL-C in diabetic subjects with hypercholesterolemia at the end of the treatment
      phase.
    


Intervention name(s): Atorvastatin; Simvastatin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Atorvastatin; Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Technology to Improve Glucose Control in Participants With Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      The main purpose of this study is to determine whether combining meal, glucose, and insulin
      data in a web-based system will improve management of type 1 diabetes (T1D). No study drug
      will be given. The study will last about 18 weeks.
    


Intervention name(s): Meal-Tagging App; Fitness Tracker
Intervention type(s): Other; Device
Intervention description(s): Meal tagging app to capture frequently eaten meals and test meals for 16 weeks.; Fitness tracker will be worn around the clock for 16 weeks.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults with T1D
Periodontal Therapy in Coronary Artery Patients
Condition: Cardiovascular Diseases; Atheroma; Coronary Artery Disease
MeSH terms: Cardiovascular Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Plaque, Atherosclerotic
Study type: Interventional

Summary: 
      Gingival inflammation has been associated with cardiovascular diseases, including heart
      attack and stroke, because of elevation of blood risk markers such as cholesterol, glucose
      and C reactive protein. The treatment of gingival diseases decreases the concentration of
      these risk factors in the blood of cardiovascular patients.
    


Intervention name(s): Subgingival scaling and root planing; Oral prophylaxis
Intervention type(s): Device; Device
Intervention description(s): Oral hygiene instruction and motivation will be provided altogether with scaling and root planing of all teeth affected by periodontitis under local anesthesia; One session of supraginigval calculus removal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Coronary artery disease; C reactive protein; Periodontitis; Periodontal therapy; Flow-mediated dilation
Evaluation of Potential Biomarkers for Obstructive Sleep Apnea and the Effect of Positive Pressure Treatment
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Observational

Summary: 
      Potential biomarkers for obstructive sleep apnea (OSA), and full genomic screening will be
      evaluated and correlated to the degree of OSA and to effect of CPAP-treatment measured by
      polygraphy.
    

Detailed description: 
      This project includes two parts:

        -  Genomic screening

        -  Biomarkers
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        OSA patients will be recruited from an outpatient sleep clinic
      
Biospecimen description: 
      Whole blood, serum, plasma
    
Keywords: Biomarkers; Genomics
Study of a Live Attenuated Chikungunya Vaccine in a Previously Epidemic Area
Condition: Chikungunya
MeSH terms: Chikungunya Fever
Study type: Interventional
Phase: Phase 2

Summary: 
      The clinical study primarily assesses the safety of MV-CHIK a new Chikungunya vaccine in a
      previously epidemic area in healthy volunteers. Secondarily, immune response and viremia will
      be assessed.

      MV-CHIK will be compared to the commercially available MMR vaccine. 80% of the subjects will
      receive MV-CHIK; 20% will receive MMR vaccine.
    

Detailed description: 
      The clinical study to be conducted under this IND will assess the safety of MV-CHIK in a
      previously epidemic area (Puerto Rico).

      A total of 100 healthy volunteers, 50 of whom are seropositive to Chikungunya at baseline and
      50 of whom are seronegative, will be randomized in a 4:1 ratio to receive either MV-CHIK or
      the commercially available MMR vaccine in a double blinded fashion. Memory aids, to be
      completed by the volunteer at home, and the investigator at scheduled follow-up visits, will
      solicit symptoms of injection site reactions, fever, headache, malaise, joint and muscle
      pain. Acute phase reactants (C-reactive protein and ferritin) will be checked routinely
      throughout the study and at the discretion of the investigator in order to help determine if
      symptoms, particularly those referred to the joints, have an immunological basis.

      This study will also evaluate the immune response in Chikungunya-exposed versus unexposed
      individuals by comparing neutralizing antibody titers at specific time points. Measles
      viremia will also be measured and compared between MV-CHIK and MMR recipients, and at three
      days after the second versus after the first dose. The relationship between measles viremia
      and the immune response to MV-CHIK will be explored.
    

Intervention name(s): MV-CHIK; MMR-vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Lyophilized, life attenuated, measles vectored Chikungunya vaccine; 5E+05 TCID50 (+/- 0.5 log) per dose; Lyophilized mixture of life attenuated Measles, Mumps, and Rubella viruses; 1000, 12500, and 1000, respectively, TCID50 per dose
Other intervention name(s): MV-CHIK vaccine; MV-CHIK/DP; MPR vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, comparator controled, randomized, double-blinded, interventional, safety study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Dedicated Drug-Drug Interaction (DDI) Study in Healthy Volunteers
Condition: Drug Drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, Open-Label, Non-Randomized, Fixed Sequence Study to Evaluate the Steady-state
      Pharmacokinetics of BLD-0409, Nintedanib and Pirfenidone when Administered Concurrently in
      Healthy Volunteers
    

Detailed description: 
      This is a single-center, open-label study designed to determine the effect of BLD-0409 on the
      PK of nintedanib and pirfenidone, all at steady state, and to evaluate the safety and
      tolerability of BLD-0409 administered with either nintedanib or pirfenidone in healthy adult
      volunteers
    

Intervention name(s): Pirfenidone 267 mg Oral Tablet; Nintedanib 150 mg Oral Capsule; BLD-0409 750 mg Oral Tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Fixed sequence use of active product, TID; Fixed sequence use of active product, BID; Fixed sequence use of active product, QD
Intervention MeSH terms: Pirfenidone; Nintedanib
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Vaginal Bromocriptine for Treatment of Adenomyosis
Condition: Adenomyosis
MeSH terms: Adenomyosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Adenomyosis is a rare non-malignant disease of the uterus that causes significant symptoms
      including heavy menstrual bleeding and pelvic pain. The only widely accepted treatment for
      adenomyosis is hysterectomy. The investigators will use a dopamine agonist, bromocriptine, as
      a therapy based on animal models of the disease and our prior clinical research to observe
      any objective improvement in the extent of the disease using Magnetic Resonance Imaging
      (MRI)and standard measurements for other gynecologic diseases to measure symptomatology.
    

Detailed description: 
      Women with adenomyosis proven with MRI will be considered for the intervention with
      bromocriptine. They will be reassessed at 1, 6 and 9 months. Patients will get a stipend for
      each visit they complete. The study will end for the enrolled subject at 9th month follow-up
    

Intervention name(s): Vaginal Bromocriptine
Intervention type(s): Drug
Intervention description(s): Patients will receive 2.5 mg of vaginal bromocriptine tablet twice a day for the intervention. This will be administered for 6 months.
Other intervention name(s): Cycloset; Parlodel
Intervention MeSH terms: Bromocriptine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adenomyosis; Dysmenorrhea; Abnormal Uterine bleeding; Heavy Menstrual Bleeding; Menorrhagia