bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of a 3-dose Vaccination Regimen With One of Three Ascending Dose Levels of Clostridium Difficile Vaccine With or Without Adjuvant in Healthy Adults Aged 50 to 85 Years
Condition: Clostridium Difficile Associated Disease
MeSH terms: Clostridium Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first-in-human study (phase 1) of a 3-dose vaccination regimen with one of three
      dose levels of C difficile vaccine with or without adjuvant in healthy adults aged 50 to 85
      years. The main goal of the study is to determine how safe and well-tolerated the vaccine is.
      In addition, the study aims to assess the immune response to the C difficile vaccine.
    


Intervention name(s): C. difficile vaccine; C. difficile vaccine +adjuvant; C. difficile vaccine; C. difficile vaccine +adjuvant; C. difficile vaccine; C. difficile vaccine +adjuvant
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): 0.5 mL IM injection; 0.5 mL IM injection; 0.5 mL IM injection; 0.5 mL IM injection; 0.5 mL IM injection; 0.5 mL IM injection
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: Clostridium difficile; vaccine
Effect of Free Fatty Acids (FFA) on Androgen Precursors in Women
Condition: Hyperandrogenism; Glucocorticoid Metabolism
MeSH terms: Hyperandrogenism
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether free fatty acids modify the androgen levels
      in healthy young women.
    

Detailed description: 
      Free fatty acids (FFA) are known to play an important role by inducing insulin resistance and
      metabolic disturbances in obesity and type 2 diabetes. In addition, FFAs seems to have a
      stimulatory effect on adrenal androgen precursors in men. However, the effect of FFAs on
      androgen precursors and androgens in women is yet unknown.

      Therefore the effect of increased FFAs on adrenal androgens and androgen precursors should be
      investigated in a randomized controlled cross-over trial.
    

Intervention name(s): lipid/heparin infusion
Intervention type(s): Drug
Intervention description(s): to perform an i.v. lipid heparin infusion infusion for 4 h
Intervention MeSH terms: Heparin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: androgens; fatty acids
Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Children and Adolescents With Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective:

      To compare the efficacy of a new formulation of insulin glargine (HOE901-U300) to Lantus in
      terms of change of HbA1c from baseline to endpoint (month 6) in children and adolescents with
      type 1 diabetes mellitus.

      .

      Secondary Objectives:

      To compare HOE901-U300 and Lantus in terms of:

        -  Percentage of participants reaching target HbA1c and fasting plasma glucose (FPG).

        -  To assess the safety of HOE901-U300 including analysis of events of hypoglycemia, events
           of hyperglycemia with ketosis, and development of anti-insulin-antibodies.
    

Detailed description: 
      The study duration per participant was approximately 58 weeks that consisted of a 2 week
      screening period, a main 6-month comparative efficacy and safety treatment period, a 6-month
      comparative safety extension period, and a 4-week post treatment follow up period.
    

Intervention name(s): Insulin glargine,300 U/mL; Insulin glargine (100 units /mL); Background therapy
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subcutaneous injection in the morning or evening using a prefilled pen. Dose titration to achieve fasting self-monitored plasma glucose (SMPG) from 90 to 130 milligram/deciliter (mg/dL) (5.0 to 7.2 millimol per liter [mmol/L]); Subcutaneous injection in the morning or evening using a prefilled pen. Dose titration to achieve fasting SMPG from 90 to 130 mg/dL (5.0 to 7.2 mmol/L); Fast-acting mealtime insulin analogs
Other intervention name(s): Toujeo ®
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Trial Comparing 19 and 25G Needles for Fine Needle Aspiration (FNA) of Solid Pancreatic Mass Lesions Greater Than 35mm
Condition: Pancreatic Cancer
Study type: Interventional

Summary: 
      This study will test two different needles for performing a biopsy of the pancreas during
      endoscopic ultrasound (EUS) procedures. Patients who are asked to participate in this study
      have a growth in the pancreas measuring greater than 35mm that needs a biopsy so that a
      diagnosis can be made. The biopsy can be performed using either a 19 or 25-Gauge needle. The
      purpose of this study is to compare which of the two needles is better for performing
      biopsies of the pancreas on masses that are greater than 35mm.
    

Detailed description: 
      Endoscopic Ultrasound-guided fine needle aspiration (EUS-FNA) can be performed using the 25,
      22 or 19 gauge (G) needles. Randomized trials have shown that all three needles are safe and
      perform equally well. However, in a retrospective study, the diagnostic sensitivity of
      EUS-FNA for pancreatic masses that measured more than 35mm was less compared to smaller size
      masses. This is because larger size tumors have more necrosis and it is difficult to identify
      cancer cells in them to make a diagnosis. Therefore, more biopsies must be performed in
      larger size tumors to establish a diagnosis. In previous studies it has been shown that the
      larger 19G needles procure larger and better quality tissue. Therefore, our hypothesis is
      that, when a larger 19G needle is used to FNA tumors more than 35mm, a diagnosis can be
      achieved with fewer passes.
    

Intervention name(s): biopsy with 19 gauge needle; biopsy with 25 gauge needle
Intervention type(s): Procedure; Procedure
Intervention description(s): biopsy with 19 gauge needle; biopsy with 25 gauge needle
Other intervention name(s): FNA; biopsy; FNA; biopsy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Pancreas; cancer; EUS-FNA; 19Gauge; 25Gauge; 35mm mass
Metabolic Effects of Switching Kaletra to Boosted Reyataz
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      To study the effects of switching from Kaletra to Boosted Reyataz on glucose, lipids and fat
      in HIV-infected patients.
    

Detailed description: 
      The primary objective of this study is to determine tissue specific glucose trafficking in
      patients before and after switching from a regimen containing Lopinavir/ritonavir (LPV/r) to
      one containing atazanavir/ritonavir (ATV/r). Secondary outcome measures of interest will
      include insulin sensitivity determined by clamp testing, and lipid metabolism and hepatic
      glucose production assessed using stable isotope techniques. We hypothesize that switching
      protease inhibitor (PI) to ATV/r from LPV/r will result in direct increases in glucose uptake
      in muscle and visceral adipose tissue in association with improvements in overall whole body
      insulin sensitivity compared to remaining on LPV/r. We will complete a prospective randomized
      trial of Human Immunodeficiency Virus (HIV) infected patients who have been on a stable
      antiretroviral (ARV) regimen containing LPV/r for at least 6 months and who will be
      randomized to either switch to a regimen containing ATV/r or remain on LPV/r for 6 months.
      Each subject will complete Positron Emission Tomography (PET) 18-fluorodeoxyglucose (FDG)
      imaging during a hyperinsulinemic clamp study at baseline and 6 months after randomization.
    

Intervention name(s): atazanavir/ritonavir; lopinavir/ritonavir
Intervention type(s): Drug; Drug
Intervention description(s): atazanavir 300mg + ritonavir 100mg once daily; patient remains on their pre-study dose of lopinavir/ritonavir
Other intervention name(s): Boosted Reyataz; Kaletra
Intervention MeSH terms: Ritonavir; Lopinavir; Atazanavir Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; Kaletra; Reyataz; Insulin sensitivity; Lipids; Body Composition; Receiving Kaletra; Treatment Experienced
Radiation Exposure During Endoscopic Retrograde Cholangiopancreatography Between Prone and Left Lateral Decubitus
Condition: Exposure to Ionizing Radiation
MeSH terms: Pressure Ulcer
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to evaluate the radiation dose to patient at two positions
      (prone and left lateral) and to medical staff during Endoscopic retrograde
      cholangiopancreatography (ERCP) procedure using dose area product (DAP) meter and
      thermoluminescent dosimeter (TLD). Data were recorded on 20 patients at prone position and 20
      patients at left lateral position.
    

Detailed description: 
      The radiographic-fluoroscopic system manufactured by Siemens Model POLYSTAR was used for ERCP
      procedure at King Chulalongkorn Memorial Hospital. Dose Area Product (DAP) manufactured by
      PTW Model DIAMENTOR E, a transmission ionization chamber was attached to X-ray collimator to
      record the dose-area (cGy.cm2) in order to determine the entrance surface air kerma (ESAK,
      mGy) of the patients at two positions (prone and left lateral) while the Kodak Portal Pack
      for localization imaging was placed on the patient's couch to determine the exposed area
      (cm2) on the surface of the patient. TLD was attached at five positions, left eye, thyroid,
      left forearm, lower abdomen and left leg of the medical staff during ERCP procedure.
    

Intervention name(s): The radiographic-fluoroscopic system
Intervention type(s): Radiation
Intervention description(s): Fluoroscopy was used during ERCP procedure. With automatic brightness adjustment, patients with thicker body will get greater radiation dose.
Other intervention name(s): Siemens Model Polystar
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Radiation exposure; ERCP
Use of Psychotropic Medications Among Pregnant Women With Bipolar Disorder
Condition: Bipolar Disorder; Pregnancy Complications
MeSH terms: Pregnancy Complications; Bipolar Disorder
Study type: Observational

Summary: 
      The objectives of the proposed project are:

        1. To describe the patterns of mood stabilizer, antipsychotic, antidepressant, and
           anxiolytic prescriptions during pregnancy over a period of 12 years (2002-2014) in women
           aged 13 to 50 years who are diagnosed with bipolar disorder in Ontario.

        2. To identify the factors associated with use of antipsychotics, antidepressants, and
           antipsychotic-antidepressant polytherapy in pregnant women diagnosed with bipolar
           disorder.

        3. To assess the impact of antipsychotics, antidepressants, and
           antipsychotic-antidepressant polytherapy on the risk of maternal, neonatal, and labour
           and delivery outcomes in women with bipolar disorder.

        4. To assess the impact of antipsychotics, antidepressants, antipsychotic-antidepressant
           polytherapy on psychiatric readmission rates during the early postpartum period in women
           with bipolar disorder.
    


Intervention name(s): Antipsychotic; Antidepressant; Antipsychotic and Antidepressant
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Antipsychotic monotherapy; Antidepressant monotherapy; Polytherapy
Intervention MeSH terms: Antipsychotic Agents; Antidepressive Agents
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Women between the ages of 13 and 50 years who were hospitalized for a singleton obstetrical
        delivery between 2002-2014. Additionally, these women must be covered under the provincial
        drug benefit plan during index pregnancy, which is defined as having filled a drug
        prescription in the period from six months prior to pregnancy to six months after delivery.
        For women who had multiple pregnancies over the study period, we will select their first
        pregnancy as the index pregnancy.
      
Keywords: bipolar disorder; adverse outcomes; readmission; polytherapy
BREATHING EXERCISES FOR LABOR PAIN AND DURATION
Condition: Labor Pain; Breathing Exercise
MeSH terms: Respiratory Aspiration; Labor Pain
Study type: Interventional

Summary: 
      This study aimed to assess the efficacy of breathing exercises (BE) during the second stage
      of labor for maternal pain, duration of labor and first-minute APGAR score. This is a
      randomized controlled trial that compares nulliparous pregnant in the second stage of labor
      instructed regarding BE with a control group (CG) that received standard care service. It was
      conducted at Nenehatun Obstetric and Gynecology Hospital between May-June 2016, in Erzurum.
      One session of BE training were given to pregnant in intervention group (IG). Visual Analog
      Scale (VAS) was performed to identify perception of pain to all pregnant during the second
      stage of birth. Time of the second stage was recorded as second (sec), and first minute APGAR
      scores were recorded. Significance was set at p<0.05.
    

Detailed description: 
      In this trial, it is aimed to assess the effectiveness of breathing exercises (BE) for
      management of labor pain during the second stage of labor. Nulliparous pregnant were
      randomized two arms. Intervention group received breathing exercise at the first stage of
      labor. Control group received routine care services. It was conducted at Nenehatun Obstetric
      and Gynecology Hospital between May-June 2016, in Erzurum, Turkey. Visual Analog Scale (VAS)
      was performed to identify perception of pain to all pregnant during the second stage of
      labor. Time of the second stage was recorded as second (sec), and first minute APGAR scores
      of newborn were recorded. All analysis was carried out using SPSS 20. Significance was set at
      p<0.05.
    

Intervention name(s): BREATHING EXERCISE
Intervention type(s): Behavioral
Intervention description(s): The intervention group was instructed on breathing exercise according to the established trial protocol.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: breath exercises; labor pain; labor duration; VAS
DES Versus BiOSS LIM - POLBOS II Study
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      Coronary bifurcation lesions pose therapeutic problems during percutaneous coronary
      interventions (PCI) and are associated with higher rates of periprocedural complications as
      well as higher rates of in-stent restenosis and stent thrombosis. Provisional T-stenting
      (PTS) is the best treatment strategy at the moment. However, the optimal approach to coronary
      bifurcations treatment is still a subject of debate, especially when the side branch is
      large, not easily accessible and narrowed by a long lesion. One of the proposed alternatives
      are dedicated bifurcation stents (DBS). However, there is large scarcity of randomized trials
      with DBS. POLBOS II study is continuation of POLBOS I (POLish Bifurcation Optimal Stenting)
      study, in which paclitaxel-eluting stent BiOSS Expert® (Balton, Poland) was assessed. Now
      performance of sirolimus-eluting stent BiOSS LIM® (Balton, Poland) is verified.
    

Detailed description: 
      After signing the informed consent patients were randomly assigned to one of two treatment
      strategies: BiOSS LIM® stent implantation or rDES implantation (envelope randomization, 1:1).
      If the patient was enrolled to rDES Group there was a second randomization: with or without
      final kissing ballooning (FKB). Clinical follow-up was performed with office visits or
      telephone contacts at 1 and 12 months after intervention. Adverse events were monitored
      throughout the study period. Follow-up coronary angiography was performed at 12 months unless
      clinically indicated earlier.
    

Intervention name(s): Coronary angioplasty with stent implantation; Dual antipletlet therapy (DAPT)
Intervention type(s): Procedure; Drug
Intervention description(s): DAPT given to each patient before stent implantation
Other intervention name(s): device: LucChopin (Balton, Poland); device: Xience (Abbot Vascular); device: Promus (Boston Scientific); device: Resolute Integrity (Medtronic); device: Biomatrix (Biosensors); device: Prolim (Balton, Poland); acetysalicylic acid; clopidogrel
Intervention MeSH terms: Clopidogrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dedicated bifurcation stent; sirolimus eluting stent
A Study To Evaluate The Safety And Efficacy Of An Investigational Diabetes Drug In Poorly Controlled Type II Diabetics
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this research study is to determine if a new investigational diabetes drug is
      safe and effective in treating people who have Type II diabetes mellitus with very high HbA1c
      or FPG (fasting plasma glucose) levels. The HbA1c test, also called the hemoglobin A1c test
      or glycated hemoglobin test, is a measurement of the average amount of sugar in the blood
      over the last 2 to 3 months. FPG is a test that measures the amount of sugar in the blood
      after an 8 hour fast.
    


Intervention name(s): rosiglitazone/metformin
Intervention type(s): Drug
Intervention MeSH terms: Metformin; Rosiglitazone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hyperglycemia; HbA1c; Hemoglobin A1c; Type 2 diabetes mellitus
Lollipop on Gastric Volume
Condition: Gastric Volume
Study type: Interventional

Summary: 
      To observe the effect of chewing lollipop on residual gastric volume in healthy volunteers
      with fasting.
    


Intervention name(s): lollipop
Intervention type(s): Other
Intervention description(s): chewing lollipop for 20min
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Effect of Coffeeberry on Mood and Cognitive Performance
Condition: Mental Fatigue; Alertness; Mood; Cognition
MeSH terms: Fatigue; Mental Fatigue
Study type: Interventional

Summary: 
      The primary aim of this randomised, double-blind, placebo-controlled, cross-over study is to
      assess the short-term cognitive effects of two beverages containing 100 and 300 mg
      coffeeberry extract (obtained from the fruit of the coffee plant (Coffea arabica) compared to
      a placebo beverage. The trial will utilise the COMPASS cognitive assessment system and
      cognitive demand battery (CDB) and mood visual analogue scales (VAS) with assessments taking
      place at baseline, 60- and 120-minutes post treatment, on four separate testing days
      separated by 7 days. A treatment containing 75 mg caffeine will be used as a positive control
      to document participants' responsiveness to an established psychostimulant.
    


Intervention name(s): Placebo; Coffeeberry; Caffeine
Intervention type(s): Other; Dietary Supplement; Dietary Supplement
Intervention description(s): 10 oz (296 ml) cherry flavored still beverage; 10 oz (296 ml) cherry flavored still beverage; 10 oz (296 ml) cherry flavored still beverage
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: alertness; mental fatigue; coffeeberry; coffee fruit
Clinical Comparison Between Two Surgical Techniques for the Treatment of Gingival Recessions
Condition: Gingival Recession
MeSH terms: Gingival Recession
Study type: Interventional

Summary: 
      The aim of this study is to test a surgical technique for the treatment of gingival
      recessions. The hypothesis of the study is to promote greater root coverage and better
      healing.
    


Intervention name(s): Periodontal surgery to gingival recessions
Intervention type(s): Procedure
Intervention description(s): Test and control technique to treat gingival recessions.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: gingival recession; acellular dermal matrix graft; root coverage
5 Alpha Reductase Inhibitors And The Risk Of Suicide And Depression
Condition: BPH; Depression; Suicide
MeSH terms: Depression; Depressive Disorder; Suicide
Study type: Observational

Summary: 
      In December 2015, Health Canada issued a warning about a potential relationship between
      suicide and finasteride use and called for further research. No population based studies have
      assessed the risk of suicide with finasteride use, and this risk is not currently part of the
      product monograph. Furthermore, the link between depression and finasteride has not been well
      studied in the older population who are the primary users of this medication.
    


Intervention name(s): 5ARI
Intervention type(s): Drug
Intervention description(s): Exposure to finasteride/dutasteride
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All men >66 years of age in Ontario between 2003-2013
Head Start Classroom-based Approaches and Resources for Emotion and Social Skill Promotion (Head Start CARES)
Condition: Teacher Practice; Child Social-Emotional Development
Study type: Interventional

Summary: 
      The purpose of this study was to deepen the evidence base for interventions that support the
      social-emotional skills that underlie children's engagement and attention to learning tasks
      by schools (learning behaviors) and their social interactions with teachers and peers (social
      behaviors). The study tested three theoretically-distinct approaches to enhancing children's
      social-emotional development, along with a comprehensive coaching and training model, on a
      large scale within the Head Start system.
    


Intervention name(s): Incredible Years Teacher Training; Preschool PATHS; Tools of the Mind
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)