bioihbjkbjnl/mcl2 huggingface dataset:
PTHrP and Osteoporosis
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 2

Summary: 
      PTH-related protein, or ''PTHrP'', is a hormone which was discovered in 1987. As its name
      implies, it is closely related to another hormone discovered in the 1920's named parathyroid
      hormone or ''PTH''. PTH has been shown to be effective in treating osteoporosis in both
      animals and humans. PTHrP has been shown to be effective in treating osteoporosis in
      laboratory animals, and there are strong scientific reasons to think that it may be effective
      in humans as well. However, no human trials with PTHrP in the treatment of osteoporosis have
      been performed. The studies in this trial are focussed on determining whether PTHrP can
      indeed increase bone mass in postmenopausal women with osteoporosis, when administered daily
      by subcutaneous injection for three months.
    


Intervention name(s): Parathyroid hormone-related protein or ''PTHrP''
Intervention type(s): Drug
Intervention MeSH terms: Hormones; Parathyroid Hormone; Parathyroid Hormone-Related Protein
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: parathyroid hormone-related protein; parathyroid hormone; anabolic skeletal therapy; postmenopausal women
Bioequivalency Study of Terbinafine Tablets Under Fasting Conditions
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional

Summary: 
      The objective of this study was the bioequivalence of a Roxane Laboratories' terbinafine
      tablets, 250 mg, to Lamisil® Tablets, 250 mg (Novartis Pharmaceutical Corporation.) under
      fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence
      crossover design.
    


Intervention name(s): Terbinafine
Intervention type(s): Drug
Intervention MeSH terms: Terbinafine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Improving Post-Prandial Blood Glucose Control With Afrezza During Closed-Loop Therapy
Condition: Post-Prandial Hyperglycemia; Post-Prandial Hypoglycemia
MeSH terms: Hypoglycemia; Hyperglycemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will be conducted in two phases; an in-patient meal study phase (Phase I) and an
      outpatient home study (Phase II). The two phase study design is chosen to enhance safety by
      testing the Afrezza Closed-Loop (CL) system in controlled in-clinic setting under study staff
      supervision before it could be investigated at the outpatient home setting. Phase II will not
      begin without the establishment of safety in Phase I.
    

Detailed description: 
      There are 2 primary study aims that this research will address. The first study aim will be
      to determine whether use of Afrezza inhaled insulin with ultra-fast kinetics will improve the
      performance of a closed-loop (CL) system, both with respect to immediate post-prandial
      hyperglycemia and the subsequent late post-prandial hypoglycemia as compared to hybrid CL
      (HCL) with subcutaneous (SC) rapid-acting insulin (RAI) pre-meal bolus.

      The second study aim will be to examine the efficiency and feasibility of Afrezza inhaled
      insulin as a pre-meal bolus and a missed meal correction bolus on mitigating post-prandial
      blood glucose control during outpatient CL therapy.

      This study will test the hypothesis that Afrezza inhaled insulin given before a meal to mimic
      physiologic first phase insulin release will limit the magnitude and rate of rise of glucose
      levels following a meal and will achieve greater percent time spent within target blood
      glucose range as compared to conventional hybrid CL therapy without inhaled insulin both in
      the in-clinic research and outpatient real-life setting.
    

Intervention name(s): DiAS; Afrezza low dose; Afrezza high dose
Intervention type(s): Device; Drug; Drug
Intervention description(s): Diabetes Assistant (DiAS) hybrid closed loop system.; Afrezza inhaled insulin low dose.; Afrezza inhaled insulin high dose.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Insulin
Induced Myocardial Ischemia: a Serial Troponin T and Troponin I Measurements
Condition: Acute Coronary Syndrome; Cardiac Ischemia
MeSH terms: Acute Coronary Syndrome; Coronary Artery Disease; Myocardial Ischemia; Ischemia
Study type: Observational

Summary: 
      Background Troponin are proteins found in the cardiomyocyte and are a cornerstone in the
      diagnoses of acute myocardial infarction. Troponin is released to the bloodstream as a result
      of an cardiomyocyte injury. Troponin is frequently assessed in hospital care for patients
      with chest pain and dyspnea.

      Guidelines recommend troponin assessment at admission and repeated at 3 to 6 hours, depending
      on the assay. High-sensitivity assays measure concentrations that are ten-times lower than
      earlier generations of assays. However, the time from when troponin is elevated in the
      bloodstream after an ischemic injury, measured with high-sensitivity assays, are not fully
      known.

      During an X-ray imaging of the heart's blood vessels (coronary angiogram) it is possible to
      do a short, controlled occlusion of coronary artery by inflating a small balloon in one of
      the coronary arteries. Numerous earlier studies in patients have used this method for induced
      occlusion of one coronary artery for 1 to 3 minutes. Only one of the studies measured
      troponin I.

      The aim with this study is to quantify and compare the release of troponin T and troponin I
      in the early hours after a controlled induced ischemia.

      Study Design This is a prospective, descriptive and experimental study. There will be
      included 40 patients, without acute ischemic cardiac disease. They will be randomized in 4
      groups.

      0: 10 patients - control group, no balloon occlusion

        1. 10 patients - balloon occlusion for 30 seconds

        2. 10 patients - balloon occlusion for 60 seconds

        3. 10 patients - balloon occlusion for 90 seconds

      Subsequently there will be assessed serial blood samples 0 - 3 hours: Every 15 minutes 3 - 6
      hours: Every 30 minutes

      Statistics This is a pilot study and it is estimated that ten patients are sufficient number
      of patients in each group to assess elevation of troponin after occlusion of coronary artery.
      The thesis is there is a dosage-response correlation between the length of balloon occlusion
      and the concentration of troponin in blood stream.
    


Intervention name(s): coronary occlusion
Intervention type(s): Other
Intervention description(s): percutaneous coronary intervention
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patient referred to coronary angiography due to suspicion of ischemic heart disease.
      
Biospecimen description: 
      Serum and plasma
Determining Shapes and Dimensions of Dental Arches for the Use in Lingual Technique.
Condition: Dental Arch Relationship Anomaly
Study type: Observational

Summary: 
      This study aims to determine the shape and dimension of dental arches from a lingual
      perspective, and determine shape and size used for lingual Orthodontics.
    

Detailed description: 
      The study sample comprised 70 Caucasian Brazilian individuals with normal occlusion and at
      least four of Andrew's six keys. Maxillary and mandibular dental casts were digitized (3D)
      and the images were analyzed by Delcam Power SHAPET 2010 software. Landmarks on the lingual
      surface of teeth were selected to determine the shape and size of dental arches.
    

Intervention name(s): general group
Intervention type(s): Other
Intervention description(s): The sample comprised maxillary and mandibular dental casts of 70 Caucasian Brazilian individuals (28 men and 42 women) with an average age of 16.4 years, all of which had natural normal occlusion with at least four of the six keys to normal occlusion. 14 The first item of the first key was considered essential for sample selection(Angle Class I molar relationship). Another inclusion criterion was that individuals should be at least 15 years of age with no odontogenic abnormalities and all permanent teeth in occlusion.
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        70 Caucasian Brazilian individuals (28 men and 42 women) with an average age of 16.4 years
      
Biospecimen description: 
      the study sample comprised 70 caucasian brazilian individuals with normal occlusion and at
      least four of Andrew's six keys.
    
Keywords: Orthodontics; Dental arch; Orthodontic appliance design.
Obesity and Diabetes Prevention Through Science Enrichment
Condition: Type 2 Diabetes; Obesity
MeSH terms: Diabetes Mellitus; Obesity; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Type 2 diabetes and obesity in children continue to increase at alarming rates with
      devastating results. However, both these metabolic diseases are largely preventable through
      adoption of a healthy lifestyle, an understanding of what happens to food in the body, energy
      balance and some simple aspects of glucose regulation. Can elementary school children be
      taught the knowledge and skills necessary to prevent type 2 diabetes and obesity? Children
      need to learn this essential knowledge and practice these important health behavior skills.
      Elementary school may be an ideal place to master this subject that is a direct and logical
      extension of current health curricula including nutrition and physical activity blended with
      science and math.
    

Detailed description: 
      Biomedical scientists lead a classroom series of interactive, inquiry-based science and
      health explorations directed at type 2 diabetes, obesity and their prevention in three
      elementary schools serving children at high risk for type 2 diabetes. Diabetes knowledge was
      measured in children and parents at the beginning, end and 9 months after the end of the
      intervention using validated questionnaires.
    

Intervention name(s): Program ENERGY; comparison
Intervention type(s): Behavioral; Other
Intervention description(s): Weekly or biweekly classroom and gym based science enrichment focused on how the body works including blood glucose regulation, healthy eating and physical activity, diabetes abd how it can be prevented
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Childhood; Prevention; Energy balance; Glucose regulation; Healthy lifestyle; Healthy eating; Active living
Autism & Anesthetic Exposure Study
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Observational

Summary: 
      As anesthesia is often needed for childhood surgery and procedures, researchers have examined
      the potential effects of anesthesia on neurodevelopment. There are few studies that have
      examined the effect of anesthesia on neurodevelopment in children with confirmed diagnoses of
      ASD, and the results of these studies are mixed. Children with neurodevelopmental disorders
      can have age-dependent variations in brain anatomy, function, and connectivity, which may
      alter their sensitivity to the potential neurotoxic effects of anesthetic and sedative drugs.
      Given the potential adverse neurodevelopmental effects of anesthesia on typically developing
      children, it is important to examine if anesthesia exposure can worsen the clinical course of
      ASD.
    

Detailed description: 
      We hypothesize that children with a confirmed diagnosis of ASD will regress developmentally
      following general anesthesia for dental surgery in comparison to children without ASD
      (controls) undergoing dental surgery. In this pilot study, we will investigate this
      hypothesis through the following objectives:

        1. to determine in a clinical study if anesthesia induces post-operative persistent adverse
           changes children with ASD as compared with typically developing controls;

        2. to determine the potential mechanism for the adverse effects of anesthetics on patients
           with ASD compared to healthy controls, peripheral blood mononuclear cells will be
           isolated from blood samples (PBMCs), before genomic DNA isolation for mitochondrial
           content analysis.
    

Intervention name(s): Dental surgery
Intervention type(s): Procedure
Intervention description(s): All types of dental surgery
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children undergoing dental surgery at The Hospital for Sick Children
      
Biospecimen description: 
      Cell lines will be established from blood samples.
    
Keywords: anesthesia
The Different Design of Orthokeratology
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      In this study, we intend to enroll orthokeratology subjects aged 8-18 years old with
      binocular myopia up to and including -4.00 D. They were randomly selected to wear both
      orthokeratology of different designs, one with an aspheric wide inversion zone design in the
      optical zone and the other with a traditional spherical curved segment design, and to
      investigate the differences between these two lenses in terms of their effectiveness in
      myopia retardation, defocus, and aberration.
    


Intervention name(s): Orthokeratology with aspheric wide inversion zone design in the optical zone; Orthokeratology with traditional spherical design in the optical zone
Intervention type(s): Device; Device
Intervention description(s): An orthokeratology lens with an altered optical zone design is designed for an aspherical wide inversion arc in the optical zone; Subjects wore the orthokeratology with traditional spherical design in the optical zone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Impact of Fish Oil Supplementation in 3rd Trimester of Pregnancy on Maternal and Offspring Health
Condition: Preterm Delivery; Atopy; Metabolic Syndrome
MeSH terms: Premature Birth; Metabolic Syndrome
Study type: Interventional

Summary: 
      The aim of the trial is to investigate the effect of daily supplementation with 2.7 grams of
      long chain n-3 fatty acids during the third trimester of pregnancy. In 1990, 533 pregnant
      women, while they were in gestational week 30, were randomized to fish oil supplements
      providing the mentioned amount of long chain n-3 fatty acids, olive oil supplements, or no
      supplements; they were asked to take the supplements until delivery. Health outcomes were
      assessed during pregnancy and delivery. Further, offspring health and development has been
      examined during the ensuring two decades by making linkages to the rich Danish health and
      administrative registries, by asking the offspring to complete web-based questionnaires, and
      by examining the offspring physically.
    


Intervention name(s): Fish oil; Olive oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 4 1-g gelatine capsules per day providing 2,7 grams long chain n-3 fatty acids; 4 1-g gelatine capsules with virgin olive oil
Other intervention name(s): Pikasol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Fish oil; Pregnancy; RCT; Birth weight; Gestational age; Asthma and allergies; Metabolic syndrome; Obesity
ERECTOR SPINAE BLOCK AFTER THORACIC SPINE SURGERY
Condition: Post Operative Analgesia
Study type: Observational [Patient Registry]

Summary: 
      the effectiveness of ultrasound guided erector spinae plane block in patients undergoing
      thoracic spine sugery
    

Detailed description: 
      bilateral erector spinae plane block would be given to patients with thoracic spine sugery
      for postoperative analgesia & its effectiveness would be evaluated for 2 days
    

Intervention name(s): ultrasound guided erector spinae plane block
Intervention type(s): Procedure
Intervention description(s): bilatral block given to patients under general anaesthesia for thoracic spine sugery to contorl post operative pain
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients underging thoracic spine sugery
Study to Investigate the Immune Response to Two Doses of VAX102 Healthy Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective is to assess the humoral and cellular immune response of the VAX102 vaccine
      delivered IM and SC in a prime-boost regimen at dose levels 1 µg or 2 µg in healthy adults
      against the influenza A virus M2e antigen after each vaccination.
    

Detailed description: 
      The primary objective is to assess the humoral and cellular immune response of the VAX102
      vaccine delivered IM and SC in a prime-boost regimen at dose levels 1 µg or 2 µg in healthy
      adults against the influenza A virus M2e antigen after each vaccination. The magnitude and
      quality of the M2e-specific B and T cells will be measured. B cell responses will be
      evaluated on pre-dose Days 0, 28 and post-dose Days 7, 35, 42 and 60. T cell responses will
      be measured on pre-dose Days 0, 28 and post-dose Days 14, 42 and 60. IgG M2e antibody will be
      measured on Days 0, 7, 14, 28, 35. 42 and 60. The secondary objective is to assess the
      safety, reactogenicity, and tolerability of the VAX102 vaccine delivered IM or SC at dose
      levels 1 µg or 2 µg, in a prime-boost dosing regimen, in healthy adults 18-49 years of age,
      inclusive.
    

Intervention name(s): VAX102
Intervention type(s): Biological
Intervention description(s): 1 ug i.m. compared to 2 ug s.c.
Other intervention name(s): STF2.4xM2e
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: influenza; influenza vaccine; universal influenza vaccine; Matrix 2e protein; M2e; Immune response
Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis
Condition: Anterior Uveitis
MeSH terms: Uveitis; Uveitis, Anterior; Iridocyclitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this phase 2 study is to determine if difluprednate ophthalmic emulsion is
      effective in the treatment of uveitis.
    

Detailed description: 
      The primary objective was to investigate the efficacy and safety of 0.05% difluprednate
      ophthalmic emulsion in patients with endogenous anterior uveitis and to determine its
      clinical usefulness for treatment of this disease in the early phase of development, in
      comparison with Rinderon® solution (containing 0.1% betamethasone sodium phosphate) that has
      widely been used for treatment of postoperative inflammation, uveitis, etc. as a steroid
      ophthalmic solution.

      The secondary objective was to establish the evaluation system for a dose-finding study.
    

Intervention name(s): Difluprednate Ophthalmic Emulsion
Intervention type(s): Drug
Intervention MeSH terms: Difluprednate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Investigation of Pharmacodynamic Effects of Dabigatran and Ticagrelor and Assessment of Ticagrelor Interaction Potential With Dabigatran
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluation of potential ticagrelor effects on dabigatran exposure and evaluation of two new
      pharmacodynamic methods
    


Intervention name(s): dabigatran etexilate; Ticagrelor; Ticagrelor; dabigatran etexilate; dabigatran etexilate
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): medium dose dabigatran; high dose ticagrelor; high dose ticagrelor; low dose dabigatran; medium dose dabigatran
Intervention MeSH terms: Dabigatran; Ticagrelor
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Contractubex Treatment in Scars After Abdominal Caesarean Section
Condition: Scars
MeSH terms: Cicatrix
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate the efficacy of Contractubex® Gel, containing
      extractum cepae, allantoin and heparin, in the treatment of scars after abdominal Caesarean
      section compared to untreated scars after abdominal Caesarean section.
    


Intervention name(s): Contractubex
Intervention type(s): Drug
Intervention description(s): Contractubex® Gel, containing 10% extractum cepae, 1% allantoin and 50/U of sodium heparin per one gram of gel.
Active drug group: The gel will be applied twice daily (morning/evening). Approximately 2 cm of the IMP are applied onto the scar by light massage rubbing carefully until the product is worked in.
Other intervention name(s): Other names have not been specified.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: scars after abdominal Caesarean section
Evaluating Pharmacogenomic Variants for Cardiology Therapeutics
Condition: Thrombosis; Stent Thrombosis; Bleeding; Myocardial Infarction; Ischemic Stroke
MeSH terms: Ischemic Stroke; Myocardial Infarction; Thrombosis; Infarction
Study type: Interventional

Summary: 
      Cipherome's Lighthouse is a clinical decision support tool that incorporates a patient's
      pharmacogenetic information to determine therapeutic strategy, including determining
      appropriate dosage or assessing the likelihood of toxicity of a therapeutic regimen.
    

Detailed description: 
      The Lighthouse tool incorporates pharmacogenetic (PGx) variants from well-established,
      evidence-based guidelines to provide personalized drug response profile(s) to guide treatment
      decisions.

      The patient specimen is genotyped using a proprietary, carefully curated pharmacogenetic
      variant panel to determine the individual's phenotype. The Lighthouse report (PGx findings)
      are provided to the clinician, and a notification is generated when the patient has a
      genotype with a deleterious drug-metabolizing phenotype.

      Evaluating the South Texas community for the pilot project will enhance the understanding of
      the impact of genetic variants on individuals of Hispanic/Latino ancestry, especially as the
      variants pertain to the efficacy and safety of medications.
    

Intervention name(s): Cipherome Lighthouse Pilot
Intervention type(s): Diagnostic Test
Intervention description(s): Preemptive pharmacogenomic testing
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There will be two study arms:
Conventional therapy (controls)-treatment with clopidogrel and no pre-emptive genotyping
Genotype-guided therapy (experimental)
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Stent Thrombosis; Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)