bioihbjkbjnl/mcl2 huggingface dataset:
Randomized Clinical Trial of Adipose-Derived Stem Cells in the Treatment of Pts With ST-elevation Myocardial Infarction
Condition: Myocardial Infarction; Coronary Arteriosclerosis; Cardiovascular Disease; Coronary Disease
MeSH terms: Cardiovascular Diseases; Myocardial Infarction; Coronary Disease; Coronary Artery Disease; ST Elevation Myocardial Infarction; Arteriosclerosis; Myocardial Ischemia; Infarction
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to establish safety and feasibility of utilizing Adipose-Derived
      Stem and Regenerative Cells (ADRC's) in patients who have suffered a ST-elevation acute
      myocardial infarction.
    

Detailed description: 
      Subjects who have coronary artery disease and have suffered a ST-elevation acute myocardial
      infarction will be evaluated for eligibility in this study. Eligible subjects will undergo
      standard treatment after admission to the hospital and will then undergo liposuction under
      local anesthesia, after which ADRC's will be isolated from the lipoaspirate. According to
      randomization subjects will receive either ADRC's or placebo.
    

Intervention name(s): Injection of ADRC's; Injection of Placebo
Intervention type(s): Drug; Other
Intervention description(s): ADRC's are injected; Placebo is injected
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADRC; Stem Cells; Myocardial Infarction; STEMI; Heart Disease; Coronary Artery Disease; Coronary Disease; ST-Elevation; AMI; Interventional Cardiology; Heart Attack
Resident Observed Burnout After Daily Supplementation With Coffee
Condition: Burnout, Professional
MeSH terms: Burnout, Professional; Burnout, Psychological
Study type: Interventional

Summary: 
      Coffee drinking is frequently reported as a negative outcome in studies on burnout, but the
      effect of an increased coffee intake on resident burnout has not been reported in the
      literature. This study is a prospective, interventional cohort study enrolling up to 50
      residents from the Internal Medicine Residency Program to look at the relationship between
      coffee and resident burnout.
    

Detailed description: 
      Resident burnout is increasingly being recognized as detrimental to both physician well being
      and patient care. It has been linked to an increased rate of medical errors and a reduced
      quality of patient care. In addition, there have been multiple high-profile physician
      suicides in the past years. This has resulted in a renewed focus on physician mental health
      and workload.
    

Intervention name(s): Daily Supplementation with Coffee
Intervention type(s): Dietary Supplement
Intervention description(s): At the beginning of study week 2 (study day 8), two coffee machines (one Nespresso Inissia and one Hamilton Beach 46205 12 Cup Programmable Coffee Maker) will be installed in the resident work rooms at each site.
Subjects will be provided with free coffee beans, milk, cream, sugar and sweetener
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study To Investigate Markers Of Inflammation In Rheumatoid Arthritis
Condition: Rheumatoid Arthritis; Osteoarthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Observational

Summary: 
      This study is being conducted to validate various biomarkers in patients with RA with varying
      levels of disease severity. Subjects with a diagnosis of rheumatoid arthritis (RA) will be
      included as controls. The sudy will measure the baseline levels and the intra- and
      inter-subject variability of exhaled nitric oxide (NO) in patients with inactive/mild and
      moderate/severe RA on stable therapy or during a course glucocorticoids. In addition exhaled
      NO levels will be correlated with intra-articular inflammation (power Doppler
      ultrasonography) as well as markers of systemic inflammation (CRP, ESR).
    


Intervention name(s): Power doppler ultrasonography; High frequency ultrasonography; Exhaled nitric oxide assessment
Intervention type(s): Procedure; Procedure; Procedure
Other intervention name(s): Exhaled nitric oxide assessment; Power doppler ultrasonography
Intervention MeSH terms: Nitric Oxide
Time perspective: Prospective
Keywords: iNOS; Rheumatoid arthritis; Exhaled NO
Reducing the Overall Risk Level in Patients Suffering From Metabolic Syndrome
Condition: Hypertension, Dyslypidaemia
MeSH terms: Hypertension; Metabolic Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the efficacy of a multi factorial preventive scheme of action
      (including fluvastatin and valsartan) to reduce the overall risk level in patients with
      metabolic syndrome.
    


Intervention name(s): Fluvastatin; Valsartan; Hydrochlorothiazide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Fluvastatin: daily 80 mg, oral; Valsartan: daily 160 mg, oral; Hydrochlorothiazide: daily 12.5mg, oral
Other intervention name(s): Lescol; Diovan
Intervention MeSH terms: Valsartan; Hydrochlorothiazide
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypertension, dyslipidemia
Bioequivalence of a FDC Tablet of Linagliptin/Metformin (2.5mg/750mg) Extended Release in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial is to demonstrate bioequivalence of a newly developed fixed dose
      combination (FDC) tablet containing linagliptin and metformin extended release compared to
      the free combination of linagliptin and metformin extended release.
    


Intervention name(s): Linagliptin; Linagliptin/Metformin ER FDC; Metformin ER
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 x Linagliptin tablet; 2 x Linagliptin/Metformin ER FDC tablet; 3 x Metformin ER tablets
Intervention MeSH terms: Metformin; Linagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Use of Somatropin in Turner Syndrome
Condition: Genetic Disorder; Turner Syndrome
MeSH terms: Turner Syndrome; Gonadal Dysgenesis; Genetic Diseases, Inborn; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in Europe. The aim of this trial is to study the dose-response
      relationship and effect of somatropin (Norditropin®) on final height in girls with Turner
      Syndrome.
    


Intervention name(s): somatropin; somatropin
Intervention type(s): Drug; Drug
Intervention description(s): 2.9 IU/m^2/day. Administered as once daily subcutaneous injection until final height is reached; 4.3 IU/m^2/day. Administered as once daily subcutaneous injection until final height is reached
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Impact of "Natural" Cesarean Delivery on Peripartum Maternal Blood Loss.
Condition: Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      Throughout the history, the neonate was dependent on maternal touch and care for survival. In
      modern obstetrics, with hospital care the neonates are seldom separated from their mothers
      after delivery. Early skin to skin (ESTS) contact after delivery was found to increase milk
      production, lactation and improve maternal and neonatal outcome.

      Oxytocin is the primary hormone responsible for uterine contraction and prevention of
      postpartum hemorrhage (PPH). ESTS contact increases oxytocin secretion.

      The rate of cesarean deliveries (CDs) increased dramatically over the past decades. CD was
      found to decrease postpartum milk production, postpones early lactation and decreases
      exclusive breastfeeding.

      During the typical CD, the neonate is usually presented for a short while to the mother and
      breastfeeding is usually delayed at least a number of hours until after the surgery and the
      recovery period.

      Natural CD, enable ESTS contact during the surgery and give the mother the opportunity to
      start breastfeeding immediately after delivery of the neonate in the surgery suit. Oxytocin
      secretion increases with ESTS and during breastfeeding.

      The aim of this study is to examine blood loss that occurs after Natural CD compared to
      standard CD without an ESTS contact.
    


Intervention name(s): Natural cesarean delivery; Standard cesarean delivery
Intervention type(s): Other; Other
Intervention description(s): Natural cesarean delivery; Standard cesarean delivery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Pharmacokinetic Characterization of the Hemophilia A Population in Spain Using myPKFiT®
Condition: Hemophilia A; Hemophilia; Factor VIII Deficiency
MeSH terms: Hemophilia A
Study type: Observational

Summary: 
      The purpose of this study is to describe the pharmacokinetic profile of patients with
      hemophilia A in prophylaxis in Spain using myPKFit®
    

Detailed description: 
      This pharmacokinetic profile will be obtained in only in patient using Advate® (INN-octocog
      alfa) or Adynovi® (INN- rurioctocog alfa pegol), both recombinant intravenous FVIII products,
      with myPKFiT®. This patients will be followed during the period of 12 months, and the
      pharmacokinetic will be measured collecting at least 2 blood samples, in which the presence
      of factor VIII will be determined by the usual clinical methods: chromogenic method or
      coagulative method.
    

Intervention name(s): octocog alfa; rurioctocog alfa pegol
Intervention type(s): Drug; Drug
Intervention description(s): Pharmacokinetic Characterization of the Hemophilia A Population in Spain using an standalone web-based software; Pharmacokinetic Characterization of the Hemophilia A Population in Spain using an standalone web-based software
Other intervention name(s): Advate®; recombinant intravenous factor VIII; recombinant intravenous factor VIII
Intervention MeSH terms: Factor VIII; BAX 855
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed with hemophilia A on prophylactic treatment with Advate® or Adynovi®
      
Biospecimen description: 
      Whole blood samples collected in citrate plasma tubes to separate it and measure
      FVIII:chromogenic and FVIII:one stage
    
Keywords: Hemophilia; Hemophilia A; Factor VIII; Advate; Antithrombotic factor; Pharmacokinetic dosing; Hemarthrosis; myPKFiT
Effect of Vitamin D Supplementation on Muscle Mass and Function
Condition: Obesity; Insulin Resistance; Inflammation
MeSH terms: Insulin Resistance; Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      The study was designed to assess the effects of vitamin D supplementation during exercise
      training on body composition, muscle function, and glucose tolerance. The investigators
      hypothesis for these studies is that vitamin D supplementation enhances exercise-induced
      increases in strength and lean mass, potentially through enhancing insulin sensitivity and
      reducing inflammation.
    

Detailed description: 
      The study was designed to assess the effects of vitamin D supplementation during exercise
      training on body composition, muscle function, and glucose tolerance. It was a double-blind,
      randomized, placebo-controlled, clinical trial with participants randomized into either a
      4,000 IU/day vitamin D or placebo group and all participants completed 12 wks (3 d/wk) of
      exercise training.
    

Intervention name(s): Vitamin D; Placebo
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): 4000 IU of vitamin D per day for 12 weeks.; Placebo (microcrystalline cellulose) ingestion each day for 12 weeks.
Other intervention name(s): cholecalciferol; microcrystalline cellulose
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: 25-hydroxyvitamin D; Parathyroid hormone; Lean mass; Muscular strength; Glucose tolerance
Coping Skills for Alcohol Use
Condition: Alcohol Drinking; Coping Skills
MeSH terms: Alcohol Drinking
Study type: Interventional

Summary: 
      A total of 120 young adults who drink to cope with negative affect will be randomized to a
      4-week, web-based intervention with interactive modules on cognitive-behavioral skills (n=60)
      or an assessment only control (n=60). Participants will complete 4 weekly assessments and a
      1- and 3-month follow-up.
    


Intervention name(s): Drinking to Cope CBT skills
Intervention type(s): Behavioral
Intervention description(s): Young adults who drink to cope with negative affect will receive 8 web-based modules with cognitive behavioral skills
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Renin and Aldosterone Levels in the Preterm Neonate At Risk for Hypertension
Condition: Hypertension; Diabetes; Infants Small for Gestational Age
MeSH terms: Hypertension
Study type: Observational

Summary: 
      The purpose of this study is to find out if mothers with high blood pressure (Hypertension)
      and/or diabetes have babies with high levels of different substances (that help to regulate
      blood pressure, called Renin and Aldosterone) in their blood. The investigators are also
      trying to determine if these babies have higher blood pressure than those babies born to
      mothers without high blood pressure or diabetes, during the first year of life.

      The investigators will measure your baby's blood pressure once a day for the first 4 days, at
      1 week of age, and then once per week until your baby is discharged. The investigators will
      also measure the blood pressure after discharge at 4 and 10 months of age, either on the day
      of your baby's follow-up appointment in the Neonatal Follow-up Clinic or at a visit to our
      Outpatient Nephrology Clinic, both at CHEO.
    

Detailed description: 
      We will compare two groups of babies born between 26+0 and 34+0 weeks gestation.Group 1 is
      the babies born to mothers with diabetes and/or high blood pressure, and babies that are
      small for dates. Group 2 are babies that are 26 to 34 weeks of age, that are born to mothers
      without these problems.

      In the study we will measure the baby's blood pressure once a day for the first 4 days, at 1
      week of age, and then once per week until the baby is discharged. We will also measure the
      blood pressure after discharge at 4 and 10 months of age, either on the day of your baby's
      follow-up appointment in the Neonatal Follow-up Clinic or at a visit to our Outpatient
      Nephrology Clinic, both at CHEO.

      As blood tests will be done. A small amount of extra blood, 0.75ml - 1.5 ml (about 1/6 -1/3
      of a teaspoon, or approximately 1 ml) will be collected for measurement of the blood
      substances we are studying will be collected when the baby has their regular non-study blood
      work.

      This will be done within six hours of birth and then again at 2-3 weeks of life.
    

Intervention name(s): presence of maternal risk factor for hypertension
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Babies born between 26 and 34 weeks gestation
      
Biospecimen description: 
      Serum samples for Renin and Alsosterone, to be discarded when study is complete.
    
Keywords: renin; aldosterone; neonate
Home-based Training in Obese Individuals
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Generally, the enhancement of physical fitness depends on the optimal modulation of different
      physiological, technical or psychological stimuli and within the factors the would contribute
      to a decrease performance level, obesity is one of them. In this context, ample evidence
      shows that obesity is associated with an augmented cardio-metabolic risk, lowered postural
      control, functional performance and strength-related variables. International guidelines
      suggests to counteract obesity to respect a minimum dosage of 150 min a week of physical
      activity at moderate intensity performed with resistance training exercises with a frequency
      of 2-3 days/week. However, in the aforementioned guidelines there is a little consideration
      for what concern the quality of motor execution (i.e., "how" an individual performs each
      movement pattern). In addition, the available literature demonstrates the effectiveness of a
      "movement-quality" training intervention on fitness parameters and postural control, compared
      to a mere conventional exercise, in normal-weight individuals . In account to this, the
      purpose is to evaluate whether a quality of movement protocol would be more effective than a
      traditional strength training exercise in improving postural control and fitness parameters
      in subjects with obesity.
    


Intervention name(s): Movement quality; Conventional Resistance Training
Intervention type(s): Other; Other
Intervention description(s): 6-week-home-based training protocols designed to improve general fitness levels and postural control performed in a circuit-training mode (time of work per set 30 s, time of rest between each exercise 15 s, time of rest between sets 2 min, total volume 3 sets) for a duration of 45 min with a frequency of 3 days per week while performing mobility, stability and motor control exercises.; 6-week-home-based training protocols designed to improve general fitness levels and postural control performed in a circuit-training mode (time of work per set 30 s, time of rest between each exercise 15 s, time of rest between sets 2 min, total volume 3 sets) for a duration of 45 min with a frequency of 3 days per week while performing traditional strength training exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; Functional performance; Postural control; Muscular strength
PET With [18F]HX4 in Head and Neck Cancer
Condition: Cancer of the Head and Neck
MeSH terms: Head and Neck Neoplasms
Study type: Interventional

Summary: 
      The aim of this study is to (i) Determine if tumor hypoxia can be accurately visualised with
      [18F] HX4 PET imaging in head and neck tumors (ii) correlate the [18F] HX4 PET images with
      blood and tissue markers and (iii) investigate the quality and optimal timing of [18F] HX4
      PET imaging (iv) compare [18F] HX4 PET uptake with [18F] FDG PET uptake before and after
      treatment.
    

Detailed description: 
      Tumor hypoxia is the situation where tumor cells are or have been deprived of oxygen. Hypoxic
      tumor cells are usually more resistant to radiotherapy and chemotherapy and more likely to
      develop metastasis. In head and neck cancer, tumor hypoxia is known to be an important
      prognostic factor for long term survival. [18F]HX4 is being developed as a diagnostic
      radiopharmaceutical for PET imaging to find a marker for hypoxia that can be used in standard
      clinical practice. Current hypoxia tracers lack reliable image quality and kinetics. Because
      of the short half life and clearance, we expect that [18F]HX4 will have a higher tumor to
      background ratio than current nitro-imidazole hypoxia markers such as [18F]-misonidazole. The
      clinical use of a reliable, non-invasive and easy to use hypoxia imaging agent could allow
      selection of patients most likely to benefit from hypoxia modifying therapies.

      Included are eligible patients with head and neck squamous cell carcinoma (T2, T3, T4, any N,
      M0) with tumor diameter ≥ 2,5 cm of the oral cavity, oropharynx, hypopharynx or larynx,
      planned to be treated with curative primary radiation treatment (+/- concurrent
      chemotherapy). Before treatment a standard planning [18F]FDG PET-CT will be performed, a
      blood sample is drawn and baseline [18F]HX4 PET scans will be performed. 18F-HX4 scans will
      be repeated after radiotherapy treatment with 20 +/- 4 Gy (approximately two weeks). Three
      months after the end of treatment a [18F]FDG PET scan will be performed.
    

Intervention name(s): Injection of [18F]HX4
Intervention type(s): Procedure
Intervention description(s): Injection of [18F]HX4 before treatment (baseline) and after radiotherapy with 20 +/-4 Gy:
[18F]HX4 PET scans; 444 MBq (12 mCi) [18F]HX4 administrated via a bolus IV injection. Image acquisition: static scan at 240 min p.i.
Venous blood sampling: before injection of [18F]HX4 (blood hypoxia markers) Follow-up (3 months after treatment): [18F]FDG PET in treatment position
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Cancer of the Head and Neck; [18F]HX4; hypoxia; PET; phase II trial
Safety Study of Cancer Stem Cell Vaccine to Treat Pancreatic Cancer
Condition: Neoplasms, Pancreas
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Most studies of cancer stem cells (CSC) involve the inoculation of cells from human tumors
      into immunosuppressed mice, preventing an assessment on the immunologic interactions and
      effects of CSCs. In this study, the investigators examined the vaccination effects produced
      by CSC-enriched populations from histologically distinct murine tumors after their
      inoculation into different syngeneic immunocompetent hosts. Enriched CSCs were immunogenic
      and more effective as an antigen source than unselected tumor cells in inducing protective
      antitumor immunity.Immune sera from CSC-vaccinated hosts contained high levels of IgG which
      bound to CSCs, resulting in CSC lysis in the presence of complement.CTLs generated from
      peripheral blood mononuclear cells or splenocytes harvested from CSC-vaccinated hosts were
      capable of killing CSCs in vitro. Mechanistic investigations established that CSC-primed
      antibodies and T cells were capable of selective targeting CSCs and conferring antitumor
      immunity.
    

Detailed description: 
      To assess the feasibility of generating CSC-loaded DC vaccines for clinical use, the
      investigators will harvest peripheral blood and tumor specimen from patients with Pancreatic
      Cancer. The investigators will purify T, B cells and generate DCs from the PBMCs of the
      Pancreatic Cancer patient.On the other hand, investigators will isolate ALDHhigh and ALDHlow
      tumor cells from the tumor specimen of the Pancreatic Cancer patient using a similar protocol
      as investigators reported .

      Aim 1: To demonstrate, in vitro, the relative cellular anti-Pancreatic Cancer CSC immunity
      induced by Pancreatic Cancer CSC-DC primed cytotoxic T cells.

      Aim 2: To determine, in vitro, specific binding and lysis of Pancreatic Cancer CSCs by
      antibodies produced by purified B cells from PBMCs stimulated with Pancreatic Cancer CSC-DC.
    

Intervention name(s): cancer stem cell vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment