bioihbjkbjnl/mcl2 huggingface dataset:
Multivitamin Support Following Bariatric Surgery
Condition: Bariatric Surgery
Study type: Observational

Summary: 
      Bariatric surgery (BS), an effective treatment for severe obesity and its comorbidities, may
      result in micronutrient and vitamin deficiencies. This monocentric prospective observational
      study aimed at evaluating the efficacy of a specifically designed vitamin/mineral formula
      (Bariatrifast) for preventing and treating micronutrient deficiencies in patients submitted
      to BS.
    

Detailed description: 
      Although BS effectively reduces body weight, improves metabolic alterations, and enhances
      overall health, it may also lead to micronutrients deficiency. This prospective observational
      study aimed at evaluating the effectiveness and safety of a specific FSMP (Food For Special
      Medical Purposes) in maintaining an adequate vitamin and micronutrient intake in patients
      with obesity submitted to VSG (Vertical Sleeve Gastrectomy) or RYGB (Roux-en-Y gastric
      bypass) . The included 20 consecutive patients with severe obesity who underwent BS (11
      males, 9 females, all aged ≥18 years, with a BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 with at least one
      obesity-related comorbidity, followed for one year after surgery.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This observational, prospective study included 20 consecutive patients with severe obesity
        who underwent BS (11 males, 9 females, all aged ≥18 years, with a BMI ≥ 40 kg/m2 or ≥ 35
        kg/m2 with at least one obesity-related comorbidity. In the, 10 patients had hypertension,
        5 insulin resistance, 5 type 2 diabetes, 2 non-alcoholic liver disease, 7 gastroesophageal
        reflux disease, 7 dyslipidemia and 2 obstructive sleep apnea. Ten of them underwent VSG and
        the other 10 RYGB. Patients were recruited at the Obesity and Lipodystrophy Center,
        University Hospital of Pisa
      
Keywords: VSG; RYGB; micronutrients deficiency
ThuLEP vs. HoLEP vs. Monopolar Enucleation in Management of BPH
Condition: Prostatic Hyperplasia, Benign; Prostate Adenoma; Lower Urinary Tract Symptoms
MeSH terms: Adenoma; Prostatic Hyperplasia; Hyperplasia; Lower Urinary Tract Symptoms
Study type: Interventional

Summary: 
      Today, endoscopic enucleation of the prostate (EEP) has been recognized a method of choice
      for treatment of benign prostatic hyperplasia (BPH) of any size, including large-sized glands
      (>80 cc). The goal of our study was to compare perioperative efficacy, functional outcomes
      and safety of different techniques of endoscopic enucleation of the prostate (monopolar
      enucleation, holmium laser enucleation, thulium laser enucleation) in a single center.
    

Detailed description: 
      HoLEP and ThuLEP or EEP have been approved by the current guidelines of the European
      Association of Urology for use in men with substantially enlarged prostates (>80 ml) as
      first-line therapy [1]. This type of operation can be performed by means of several sources
      of energy.

      To our knowledge, there were no studies comparing efficacy and complications of these three
      treatment modalities.

      In this study the investigators have evaluated efficacy of Thulium-fiber laser enucleation
      (120 W thulium fiber laser Urolase, IPG IRE-POLUS, Russia with wavelength of 1940 nm) and
      monopolar enuclation in comparision with HoLEP (VersaPulse Powersuite 100, Lumenis,
      USA/Israel) in reduction of LUTS secondary to BPH in a prospective randomized trial.

      All peri-operative parameters, urinary flow parameters, prostate size changes, erectile
      function and complications associated with the procedures were compared.
    

Intervention name(s): Thulium-fiber laser enucleation of the prostate; Monopolar enucleation of the prostate; Ho:YAG laser enucleation of the prostate
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): A high-power (120 W) thulium fiber laser (Urolase, IPG IRE-POLUS, Russia) with wavelength of 1940 nm was used for thulium laser enucleation. In our study, we used a 600-μm laser fiber. The operations were performed at power of 60 W energy of 1.5 J and repetition rate of 40 Hz. Laser power in the verumontanum zone was decreased to 30 W and repetition rate to 20 Hz.; Monopolar enucleation was performed with a high-frequency generator (50-60 Hz), a pusher-electrode, and a hook-electrode.; Holmium laser enucleation of prostatic hyperplasia was performed with a 100 W laser (VersaPulse Powersuite 100, Lumenis, USA/Israel) with wavelength of 2100 nm and 550-μm fiber at the tip. The operation was performed at power of 70 W; it was decreased to 40 W when incisions were made at the verumontanum.
Other intervention name(s): ThuLEP; Monopolar enucleation; HoLEP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: laser; HoLEP; ThuLEP; Thulium; Thulium-fiber; BPH; EEP; monopolar enucleation
Intralesional Versus Intramuscular Methotrexate for Non-melanoma Skin Cancers
Condition: Non-melanoma Skin Cancers
MeSH terms: Skin Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      to compare the effectiveness and safety of intralesional vs. systemic MTX in NMSC management
    

Detailed description: 
      Intralesional methotrexate (MTX) could to be promising conservative alternative for
      non-melanoma skin cancer (NMSC). Systemic MTX was attempted as adjuvant for locally-advanced
      NMSC.
    

Intervention name(s): Methotrexate
Intervention type(s): Drug
Intervention description(s): A randomized comparative effectiveness clinical trial
Intervention MeSH terms: Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Non-melanoma skin cancer; Intralesional methotrexate; Systemic methotrexate; Intramuscular methotrexate; Keratoacanthoma; Basal cell carcinoma; Squamous cell carcinoma
Supplemental Benefit of Angiotensin Receptor Blocker in Hypertensive Patients With Stable Heart Failure Using Olmesartan
Condition: Chronic Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate whether an angiotensin II receptor blocker
      (olmesartan), in addition to conventional treatment, will reduce the mortality and morbidity
      in hypertensive patients with stable chronic heart failure.
    


Intervention name(s): olmesartan medoxomil
Intervention type(s): Drug
Intervention description(s): 5 to 40mg P.O. daily until the end of the study
Intervention MeSH terms: Olmesartan; Olmesartan Medoxomil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Short Stature Related Distress
Condition: Idiopathic Short Stature; Self Image
MeSH terms: Dwarfism
Study type: Interventional
Phase: Phase 4

Summary: 
      The research aims to provide data on gender-related psychological impact of GH (Growth
      Hormone)treatment. Implicit measurable psychological metrics of the therapy outcome on males
      are to be evaluated in a Prospective Randomized Controlled Trial. As a secondary axis of the
      study, the investigators aim to provide descriptive documentation of the unique distress
      signal manifestation implicitly shown by Idiopathic Short Stature (ISS) boys and suggest
      methods of early detection and measurement of such manifestations that can be used to cement
      guidelines for the treatment in GH.
    

Detailed description: 
      Study Design:

      A prospective randomized, double blind, placebo controlled trial design, comparing four
      research groups, with 4 repeated psychological measures (before treatment, after 3
      months,after 1 year, and at the end of treatment, after 4 years).

      The study will be divided into two segments:

      Segment 1:double blind, placebo controlled, will include the first 60 ISS (Idiopathic Short
      Stature)recruited patients. Patients in this segment will be randomized to one of the growth
      hormone treatment groups in a ratio of 2:1. 40 patients will be treated 4 years with GH and
      20 patients will be treated with placebo at the first year of the study and will have the
      option to start GH treatment after one year, for a duration of 3 years.

      Segment 2:after the enrollment to segment 1 will end, enrollment to segment 2 will
      begin.Participants in segment 2 (patients with ISS and short stature) will serve as control
      groups and therefore will not be treated with growth hormone. Patients in Segment 2 will be
      evaluated only once.

      The 4 repeated psychological evaluations (before treatment,after 3 months, after 1 year, and
      at the end of treatment, after 4 years)will include the following:

        1. Implicit Association Test

        2. Masculine Self Image

        3. Pictures Projective Test

        4. The Rosenberg Self Esteem Scale-a self report measure of explicit self- esteem

        5. Quality of Life Questionnaire

        6. Silhouette Apperception Technique (SAT)- a self report measure assessing children's and
           adolescent's perception of their own body size compared with that of their age-related
           peers

        7. Child Behavior Checklist
    

Intervention name(s): GH treatment (Genotropin); 1 year treatment with placebo followed by optional 3 years of GH treatment
Intervention type(s): Drug; Drug
Intervention description(s): 4 years treatment with GH; 1 year treatment with placebo followed by optional 3 years of GH treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Idiopathic Short stature; Self Image; GH therapy; Psychological distress
Cost-effectiveness Study of Symbicort as Maintenance and Reliever Therapy (SMART)
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      This study is an economic evaluation of Symbicort (Budesonide/formoterol) as maintenance and
      reliever therapy (SMART) versus its competitive alternatives.

      The aims of this study are:

        -  To estimate the relative effectiveness of each one of the alternatives in the management
           of patients with moderate to severe asthma through a systematic review for the following
           outcomes:

             -  Cumulative incidence of asthma severe exacerbations symptoms

             -  Safety of each alternative (frequency of adverse events and complications due to
                the medications)

        -  To estimate the direct medical costs of treating with each pharmacologic alternative:
           Symbicort as SMART versus increased use of inhaled corticosteroids or Adding long-acting
           inhaled beta 2 agonist plus inhaled corticosteroids.

        -  To create a decision analysis model (decision tree) that allows comparisons between the
           alternatives on expected values and costs.

        -  To calculate the average and incremental cost-effectiveness ratios.

        -  To carry out a sensitivity analysis to test de robustness of the cost-effectiveness
           results allowing for reasonable changes in expected values and costs.
    


Observational model: Cohort
Sampling method: Non-Probability Sample
Study population: 
        Primary care
      
Keywords: Cost-effectiveness analysis; Symbicort
Recruitment Strategies Comparing Different Strategies in Sleep Apnea and Prediabetes
Condition: Sleep Disorder; Pre Diabetes; Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Wake Disorders; Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      Recruitment strategies comparing different strategies.
    

Detailed description: 
      Patients with prediabetes and moderate-to-severe Obstructive Sleep Apnea (OSA). To determine
      the recruitment yields from electronic medical record (EMR) vs the general community. To
      assess the adherence to positive airway pressure (PAP) therapy among patients with
      prediabetes and moderate-to-severe OSA.
    

Intervention name(s): Lifestyle Intervention
Intervention type(s): Behavioral
Intervention description(s): A lifestyle intervention program adapted from the Diabetes Prevention Program (DPP). Study participants will start lifestyle intervention on the day of initiating PAP therapy. The 3-month program will be followed: Patient-facing Online Platform: The program will be accessible to study participant via the Web or a Web application available for the Android and iOS devices. Behavioral Weight Loss Goals and Lessons: The program begins with an introductory session that presents the basic goals for the program followed by 12 weekly multimedia lessons. Submission of self-monitoring data: Participants will submit daily weight, caloric intake, and physical activity minutes at least weekly to the study website for 12 weeks. Automated Feedback: In response to the self-monitoring data, participants receive a weekly automated message that compares participants' self-reported values to participants' goals for weekly and overall weight loss, caloric intake, and physical activity minutes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pre-diabetes; Sleep Apnea; PAP Therapy; Obstructive Sleep Apnea
Eradication of H. Pylori Infection With Moxifloxacin
Condition: Helicobacter Pylori Infection; Helicobacter Pylori Infection, Susceptibility to
MeSH terms: Infections; Communicable Diseases; Helicobacter Infections; Disease Susceptibility
Study type: Interventional
Phase: Phase 3

Summary: 
      The main objective of the study is to compare the effectiveness of moxifloxacin triple
      therapy with levofloxacin-based sequential therapy in terms of eradication rate, safety, and
      patient compliance.
    

Detailed description: 
      Patients who were confirmed to be positive for Helicobacter Pylori infection were randomly
      assigned to the eradication treatments. At four weeks after completion of eradication
      therapy, H. pylori tests were performed with a Stool antigen test.
    

Intervention name(s): Sequential Regimen: Levofloxacin 500 mg BID, Amoxicillin 1 gm BID, omeprazole 20 mg BID for first five days followed by Levofloxacin 500 mgBID, Tinidazole 500 mg BID, Omeprazole 20 mg BID; Triple Regimen: Moxifloxacin 400mg OD, Amoxicillin 1 gm BID, Omeprazole 20mgBID
Intervention type(s): Drug; Drug
Intervention description(s): The eradication rate of H. Pylori with levofloxacin-based sequential therapy; The eradication rate of H. Pylori with moxifloxacin-based triple therapy
Other intervention name(s): Levofloxacin; Amoxicillin; Omeprazole; Tinidazole; Moxifloxacin; Amoxicillin; Omeprazole
Intervention MeSH terms: Amoxicillin; Moxifloxacin; Levofloxacin; Ofloxacin; Tinidazole; Omeprazole; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients were randomized into two regimens:
Levofloxacin 500mg BID, Amoxicillin 1 gm BID, Omeprazole 20 mg BID for first five days followed by Levofloxacin 500 mg BID, Tinidazole 500mg BID, Omeprazole 20 mg BID, or
Moxifloxacin 400 mg OD, Amoxicillin 1 gm BID, Omeprazole 20 mg BID.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Triple therapy with moxifloxacin; Helicobacter pylori; Levofloxacin sequential therapy; Stool Antigen test
Endotracheal Tube Shapes for Intubation With Videolaryngoscope
Condition: Anesthesia
Study type: Interventional

Summary: 
      In this study, investigators will compare the efficacy of two shapes of endotracheal tube
      molded by stylet in endotracheal intubation using videolaryngoscope (McGrath MAC®). The
      participants will randomly be divided into two groups; J-shaped tube and 60-degrees-curved
      tube.
    

Detailed description: 
      Since the intubation using videolaryngoscope does not need straightened
      oral-pharyngeal-laryngeal axis, certain curvature of endotracheal tube is needed for the
      successful intubation using the videolaryngoscope.

      Participants in both groups will be intubated with videolaryngoscope (McGrath MAC®). Stylet
      will be inserted in the endotracheal tubes and will be bent to a specific shape by the
      assigned group. In the J-shaped tube group, endotracheal tube will be molded to a shape
      similar to the blade of the videolaryngoscope (McGrath MAC®). In the 60-degrees-curved tube
      group, endotracheal tube will be bent 60 degrees. Time to intubation, intubation attempts and
      ease of intubation wil be assessed.
    

Intervention name(s): J shaped stylet used for endotracheal intubation; 60-degrees stylet used for endotracheal intubation
Intervention type(s): Device; Device
Intervention description(s): After inserting a stylet into the endotracheal tube, the tube will be molded into a J-shape.; After inserting a stylet into the endotracheal tube, the tube will be bent 60-degrees.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Study to Assess the Efficacy and Safety of a PARP Inhibitor for the Treatment of BRCA-positive Advanced Ovarian Cancer
Condition: Ovarian Neoplasm
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to see if the drug KU 0059436 is effective and well tolerated in
      treating patients with measurable BRCA1- or BRCA2-positive advanced ovarian cancer and for
      whom no curative therapeutic option exists.
    


Intervention name(s): KU-0059436 (AZD2281)(PARP inhibitor); KU-0059436 (AZD2281)(PARP inhibitor)
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): Olaparib
Intervention MeSH terms: Olaparib; Poly(ADP-ribose) Polymerase Inhibitors
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Advanced ovarian cancer; Poly(ADP ribose) polymerases; KU-0059436; AZD2281; BRCA1 protein; BRCA2 protein
Efficacy and Safety Study of GerEPO
Condition: Chronic Renal Failure Related Anemia
MeSH terms: Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to establish the equivalence of GerEpo with the standard
      treatment Eprex® for a treatment period of 12 weeks in patients on Hemodialysis with respect
      to hemoglobin response and to establish the longer-term safety profile of GerEpo, with
      special regards for the occurrence of Pure Red Cell Aplasia (PRCA) and other immunogenicity
      related adverse event
    

Detailed description: 
      270 patients on Hemodialysis from 25 participating sites who meet inclusion/exclusion
      criteria will be enrolled into the trial. At the end of the comparative trial, subjects on
      either arm of the study may opt to enter a longer term cohort study designed to establish the
      longer-term safety profile of GerEpo, with special regards for the occurrence of Pure Red
      Cell Aplasia (PRCA) and other immunogenicity related adverse event.

      This second part of the study is also opened to all subjects who have given written informed
      consent, and have ESRF with CRF related anemia who according to current guideline should be
      treated with Epoetin. Subjects need not be included in the first part of the study.

      All patients shall be treated with GerEpo and thereafter observed for at least 1 year to
      actively monitor for the occurrence of PRCA and other immunogenicity related adverse events.
      The cohort study shall continue until at least 10,000 patient-years of observation have
      accrued on the study database.
    

Intervention name(s): GerEPO
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Pharmacodynamic and Pharmacokinetic Study of RO4917838 in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This single-center, randomized, double-blind, four-period crossover study will investigate
      the effect of alcohol on the pharmacodynamics and pharmacokinetics of RO4917838 in healthy
      volunteers. Healthy volunteers will receive 4 treatments in a randomized order: single dose
      of RO4917838 and alcohol, RO4917838 and non-alcoholic drink, placebo to RO4917838 and
      alcohol, and placebo to RO4917838 and non-alcoholic drink.
    


Intervention name(s): RO4917838; Placebo to RO4917838; Alcohol
Intervention type(s): Drug; Drug; Other
Intervention description(s): Single dose of RO4917838; Single dose of placebo to RO4917838; Standard alcoholic drink
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Effect of Remote Ischemic Preconditioning on Children Undergoing Cardiac Surgery
Condition: Cyanosis
MeSH terms: Cyanosis
Study type: Interventional

Summary: 
      This study is conducted in order to evaluate the effect of remote ischemic preconditioning on
      children undergoing cardiac surgery, especially focusing on possible differences according to
      preoperative cyanosis.
    


Intervention name(s): RIPC (remote ischemic preconditioning)
Intervention type(s): Other
Intervention description(s): RIPC will be performed by four 5-min cycles of lower limb ischemia and 5 in reperfusion using blood-pressure cuff inflated to a pressure 15 mmHg greater than the systolic arterial pressure measured via arterial line.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: troponin, open heart surgery, children
Oral Multiple-dose Study in Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      A study was to evaluate the safety and plasma concentration changes of quetiapine after
      repeated administration of FK949E (extended-release formulation of quetiapine) in patients
      with major depressive disorder (MDD).
    

Detailed description: 
      The objective of the study was to evaluate the safety and pharmacokinetics of multiple oral
      doses of FK949E (extended-release formulation of quetiapine) of three doses in patients with
      major depressive disorder (MDD).
    

Intervention name(s): FK949E
Intervention type(s): Drug
Intervention description(s): Oral
Other intervention name(s): extended-release formulation of quetiapine
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Antipsychotic; FK949E; Quetiapine