bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Education on the Responses to Meal Ingestion
Condition: Healthy
Study type: Interventional

Summary: 
      The effect of education on the responses to a probe meal (250 mL vegetable soup cooked at low
      temperature and 25 g bread) will be studied in a parallel design. The effects of education
      will be tested in two different groups in random order: real versus sham education. In each
      group the responses to a probe meal will be tested on 2 different days before and after the
      intervention. Participants will be instructed to eat a standard dinner the day before, to
      consume a standard breakfast at home after overnight fast, and to report to the laboratory,
      where the probe meal will be administered 3 h after breakfast. Studies will be conducted in a
      quiet, isolated room with participants sitting on a chair. Perception will be measured at 5
      min intervals 10 min before and 20 min after ingestion and at 10 min intervals up to 60 min
      after the probe meal.
    


Intervention name(s): Education; Sham
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Generation of Biological Samples Positive to Fluconazole for Anti-Doping Control
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Background:

      Androgens are used for doping purpose because they can increase muscle mass and strength.
      These drugs are included in the list of prohibited substances of the World Anti-Doping Agency
      (WADA). The prohibition of its use has given rise to a great variety of strategies, including
      indirect androgenic doping (increasing endogenous testosterone production) or masking of
      exogenous testosterone administration.

      Fluconazole is an imidazole antifungal that inhibits certain cytochrome P-450 dependent
      enzymes participating in the synthesis of steroid hormones. Concomitant fraudulent
      administration of testosterone and fluconazole may cause lower steroid concentrations in
      urine, leading to false negatives in the doping control. Thus, fluconazole may be used in
      athletes to mask exogenous steroid administration.

      Hypothesis:

      The oral administration of 12,5 mg of hydrochlorothiazide in healthy subjects allows
      generating detectable concentrations of the drug in urine. Positive urine samples will enable
      to identify analytical strategies for doping control.

      Objectives:

      Primary objective: To measure the concentrations of fluconazole in urine for anti-doping
      control samples.

      Secondary objectives: To identify fluconazole metabolites in urine. To explore the time
      window in which the drug or its metabolites can be detected in urine after administration. To
      assess safety and tolerability of the drug used.

      Methods:

      Phase I, open, non-randomized clinical trial, with a treatment condition (fluconazole)
      administered in a single oral dose to 2 subjects.
    


Intervention name(s): Fluconazole
Intervention type(s): Drug
Intervention description(s): 50 mg of fluconazole administered orally in a single dose.
Intervention MeSH terms: Fluconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Fluconazole; Anti-doping control; Athletic performance
Safety and Efficacy Study of PN2034 in Type 2 Diabetes Patients on Concomitant Rosiglitazone and Metformin (or Avandamet)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to evaluate the safety and efficacy of PN2034 administered to type 2
      diabetics on concomitant rosiglitazone and metformin (or Avandamet) therapy as measured by
      change in glycosylated hemoglobin (HbA1c) levels from baseline to Week 12. Also the study
      will evaluate the effect of PN2034 on glucose control as measured by fasting plasma glucose
      (FPG) and on fasting lipid levels: triglycerides, total cholesterol, high-density
      lipoproteins (HDL), low-density lipoproteins (LDL), and very low-density lipoproteins (VLDL).
    


Intervention name(s): rosiglitazone; metformin; PN2034
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Metformin; Rosiglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: diabetes, type 2
Clinical Observation of the Transscleral Suture Fixation of Posterior Chamber Intraocular Lens in Eyes With Inadequate Capsule Support
Condition: Absence of Capsule Support; Aphakia
MeSH terms: Aphakia
Study type: Observational

Summary: 
      To present the follow-up outcomes of transscleral suture fixation of posterior chamber
      intraocular lens (PCIOL) in eyes with inadequate capsule support.
    


Intervention name(s): posterior chamber intraocular lens implantation
Intervention type(s): Procedure
Intervention description(s): patients who underwent transscleral sutured posterior chamber intraocular lens implantation
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who underwent transscleral sutured PCIOL implantation between January 2017 and
        August 2018, in Eye Center of the Second Affiliated Hospital, Zhejiang University School of
        Medicine, Hangzhou, China.
Study of NV-101 for Safety and Efficacy in Pediatric Dental Patients Undergoing Procedures
Condition: Anesthesia, Dental
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase 2 clinical study is designed as a multicenter, randomized, blinded, controlled
      study to evaluate the safety and efficacy of NV-101 in approximately 150 children 4 to 11
      years of age. NV-101 or sham injection is administered at the completion of a dental
      procedure requiring local anesthesia with 2% lidocaine with 1:100,000 epinephrine. The dental
      procedure(s) shall be performed in a single quadrant of the mouth and include cavity
      preparation, restoration/filling, teeth cleaning (non-surgical scaling and/or root planing),
      or crowns.
    


Intervention name(s): Phentolamine Mesylate (NV-101)
Intervention type(s): Drug
Intervention MeSH terms: Phentolamine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Soft Tissue Anesthesia (Numbness)
Implementation of the Individual Danish Emergency Process Triage
Condition: Acute Disease; Emergencies; Clinical Syndrome
MeSH terms: Emergencies; Acute Disease
Study type: Interventional

Summary: 
      The purpose of the study is to implement and evaluate a novel triage algorithm for risk
      stratification of acutely admitted patients in the Emergency Department.
    

Detailed description: 
      Triage algorithms are used worldwide to risk assess and prioritize patients in the Emergency
      Departments. The aim is to identify patient at risk of deterioration or death and/or with a
      imminent need of treatment. The triage algorithms are also developed to identify patients at
      low risk, who safely can be assigned to the waiting room.

      Currently, several different triage algorithms are used, and they are mostly based on
      consensus and exper- opinion. Therefore evidence concerning triage is limited.

      The investigators has developed a novel evidence-based triage algorithm with integrated
      individual clinical assesment. The vitals measured at admission assigns the patient to a
      triage category, and based upon the clinical appearance of the patients, the triage nurse can
      adjust the assigned triage category to better reflect the patient. The triage algorithm used
      in Denmark is "DEPT", this algorithm is based purely on vitals and cause of admission and can
      not be adjusted.

      I-DEPT is designed as a cluster randomized stepped-wedge non-inferiority study. The Aim is to
      implement and compare I-DEPT to the existing triage algorithm. All Emergency Departments in
      the Capitol Region and the Region og Zealand in Denmark will implement I-DEPT one department
      at a time (8 centers). The first will start the implementation on october 1, 2020 and after
      two months the next center will implement I-DEPT. Every two months a new center will start.
      During 16 months all centers will have implemented I-DEPT the sequence of centers was
      determined by randomization. The first 30 days of implementation will be censored and not
      included in the final analyses. The study will conclude with a period of 30 days follow-up.
      Patients will only be included once.
    

Intervention name(s): I-DEPT; DEPT
Intervention type(s): Other; Other
Intervention description(s): Implementation of the novel triage algorithm; Existing triage algorithm
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Stepped-Wedge cluster randomized design
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: triage; risk stratification; emergency department
Pain Perception After Tubal Ligation
Condition: Pain
Study type: Observational

Summary: 
      The purpose of this study is to attempt to determine retrospectively whether there was a
      statistically significant difference in patient need for postoperative narcotics between two
      different groups of women who received a laparoscopic tubal ligation. One group received a
      local anesthetic injection or gel at the surgical sites, in addition to general anesthesia.
      The other group did not receive any local anesthetic but did receive general anesthesia. The
      investigators hypothesize that the group that received the local anesthetic injection or gel
      had lower average postoperative narcotic requirements and shorter postoperative dismissal to
      home times than the group that did not receive the auxiliary local anesthetic.
    


Intervention name(s): Bupivacaine, Lidocaine
Intervention type(s): Drug
Intervention description(s): Injection at surgical port site of 0.25% Bupivicaine, 2.5 mg/mL NaCl solution and/or application of Lidocaine HCl jelly 2% aqueous, up to 5 mL
Other intervention name(s): Marcaine
Intervention MeSH terms: Lidocaine; Bupivacaine
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Urban clinic population, mix of ethnicities, most are Medicaid patients
      
Keywords: postoperative pain; tubal ligation; local anesthetic
Hepatitis B Vaccination in HIV-infected Adults With Low CD4 Cell Counts
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aimed to evaluate the efficacy of different hepatitis B vaccination regimens in
      HIV-infected adults with low CD4 cell count in northern Thailand.
    

Detailed description: 
      HIV-infected adults with CD4+ cell counts < 200 cells/mm3, undetectable plasma HIV-1 RNA, and
      negative for all HBV markers were randomly assigned to receive one of these 2 regimens of
      recombinant hepatitis B vaccine (Centro De Ingenieria Genetica Y Biotecnologia, La Habana,
      Cuba); 1) 20 μg IM at months 0, 1, and 6 (3-standard doses group), and 2) 20 μg IM at months
      0, 1, 2, 6 (4-standard doses group).

      This study aimed to evaluate the efficacy and safety of these 2 hepatitis B vaccination
      regimens at month 7 after vaccination.
    

Intervention name(s): Recombinant Hepatitis B vaccine [(CIGB) La Habana, Cuba]
Intervention type(s): Biological
Intervention description(s): Different HBV vaccine regimen in each group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HBV vaccination, immunity
Study to Evaluate the Safety and Efficacy of Two Adalimumab Dosing Regimens in Subjects With Moderate to Severe Ulcerative Colitis
Condition: Ulcerative Colitis (UC)
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate safety and efficacy of two adalimumab dosing regimens for induction and
      maintenance (standard and higher dosing) in achieving clinical remission in subjects with
      moderately to severely active ulcerative colitis.
    


Intervention name(s): Adalimumab; Placebo
Intervention type(s): Drug; Other
Other intervention name(s): Humira
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ulcerative Colitis
Comparing Cap-assisted Water Exchange and Water Exchange in Colonoscopy
Condition: Colonoscopy; Intubation Time; Cap-assisted Colonoscopy
Study type: Interventional

Summary: 
      This prospective, randomize, controlled trial will compared cap-assisted water exchange with
      water exchange in patients undergoing sedated colonoscopy. Investigators test the hypothesis
      that that cap-assisted water exchange is more efficient and causes a shorter insertion time.
    


Intervention name(s): cap-assisted water exchange; water exchange
Intervention type(s): Device; Procedure
Intervention description(s): a transparent cap was mounted to the tip of colonoscopy when water exchange was performed.; water was infused and suctioned at the same time during insertion of colonoscope
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Thalidomide in Treating Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Crohn's disease (CD) is a chronic gastrointestinal inflammatory disease characterized by
      relapse and progression. The incidence and prevalence of IBD are increasing in different
      regions around the world, indicating its emergence as a global disease. Though modern medical
      therapies including immunomodulators and biologic agents have revolutionized treatment of CD,
      the occurrence of steroids-dependence and resistance or intolerance to medical therapy is
      quite common. The limitation of present therapeutic management and the high expense of
      biologic agents leads to the treatment of CD become "refractoriness". The occurrence rate of
      steroids-dependence and resistance or intolerance to thiopurine therapy is quite high during
      the course of CD. Approximately 38% of cases required surgery within 10 years. Therefore, the
      management of such refractory CD remains a great therapeutic challenge for clinicians.

      Thalidomide is an oral agent that has immunomodulatory, antiangiogenic and TNF(tumor necrosis
      factor)-a- suppressing effects. The potential role for thalidomide in the treatment of
      refractory paediatric and adult CD has been investigated in more and more small open-label
      studies and retrospective case series. Recently, a randomized controlled trial showed
      thalidomide improved clinical remission at 8 weeks of treatment and longer-term maintenance
      of remission in pediatric refractory CD. Gerich et al reported in a retrospective study that
      thalidomide improved long-term outcomes among 37 refractory CD adults followed up for a
      median of 58 months. However, the dose of thalidomide used in these studies ranged from
      50mg/d to 150mg/d, and the occurrence rate of side effects reported variously but all quite
      high. The side effects related to the dose of thalidomide were the major concerns of using it
      in CD. Moreover, the effect of thalidomide on endoscopic response including mucosal healing
      which is a more objective and important outcome in CD was rarely reported. Therefore the aim
      of this study is to investigate the efficacy on clinical and endoscopic response and the
      adverse effects of using low-dose thalidomide in active adult CD patients.
    


Intervention name(s): Thalidomide
Intervention type(s): Drug
Intervention MeSH terms: Thalidomide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Tolerability of SPD503 and Psychostimulants in Children and Adolescents Aged 6-17 With Attention-Deficit/Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and tolerability of administering SPD503
      (Guanfacine hydrochloride) with psychostimulants (amphetamine or methylphenidate) for
      treatment of ADHD in children and adolescents aged 6-17
    


Intervention name(s): Methylphenidate + SPD503 (Guanfacine hydrochloride); Amphetamine + SPD503
Intervention type(s): Drug; Drug
Intervention MeSH terms: Guanfacine; Methylphenidate; Amphetamine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
RAPP-children, Rhinitis & Asthma in Patient Perspective: Development and Validation of a Questionnaire for Quality of Life Evaluation in Children With Asthma and Allergic Rhinitis
Condition: Asthma; Allergic Rhinitis
MeSH terms: Rhinitis; Asthma; Rhinitis, Allergic
Study type: Observational

Summary: 
      This observational study aims at developing and validating a simple questionnaire to be
      routinely applied in the clinical practice, for the evaluation of the quality of life in
      children with concomitant asthma and allergic rhinitis. The study consists of two phases:

      Phase 1: Development of the RAPP-children questionnaire starting from the validated
      RHINASTHMA-children questionnaire.

      Phase 2: Administration and validation of the RAPP-children questionnaire. 150 children with
      concomitant asthma and allergic rhinitis will be followed-up for one month. Both at baseline
      and after one month, the RAPP children and several other standardized questionnaires will be
      administered.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A study population of 150 children with concomitant asthma and allergic rhinitis, aged 6 to
        11 years, both males and females, followed-up for one month at the outpatient clinic of
        Pediatric Allergology & Pulmonology (PAP) within the Institute of Biomedicine and Molecular
        Immunology (IBIM) of the National Research Council (CNR) of Palermo (IBIM CNR).
Countering Young Adult Tobacco Marketing in Bars
Condition: Smoking Cessation
Study type: Interventional

Summary: 
      The goal of the study is to implement and evaluate interventions to decrease smoking among
      young adults attending bars and nightclubs. It is believed that the proportion of young adult
      current smokers during and after the intervention will be significantly less than the
      proportion of young adult smokers before the intervention in each of the study cities.
    


Intervention name(s): Anti-smoking social marketing campaign
Intervention type(s): Behavioral
Intervention description(s): We will utilize industry market research tools to define the target audience (segment of community with high smoking prevalence and high social influence) and directly counter tobacco industry lifestyle marketing strategies through local promotion of a smokefree brand and branded bar and club events.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Smoking; Smoking Cessation; Tobacco Use Cessation; Social Networks; Social Control, Informal
The Efficacy and Safety of Ramosetron in Patients Undergoing Off Pump Coronary Artery Bypass Surgery
Condition: Coronary Artery Bypass Graft Triple Vessel; Hypotension
MeSH terms: Hypotension
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effects of ramosetron on corrected QT interval in
      patients undergoing off pump coronary artery bypass surgery.
    


Intervention name(s): Ramosetron; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): 0.3 mg IV as bolus before induction of general anesthesia; 2 ml normal saline as bolus before induction of general anesthesia
Other intervention name(s): Nasea
Intervention MeSH terms: Ramosetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Energy Balance for Prostate Cancer Survivorship
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effectiveness of a weight management program for
      men undergoing a prostatectomy by seeing if the program is easy to follow, impacts weight
      gain, and reduces risk of cancer recurrence in the participants.
    

Detailed description: 
      The weight management program is designed to help participants lose weight before their
      prostatectomy and to help them maintain that weight loss after surgery. There are four main
      components to the weight management program. The four components of the program are:

        1. Diet

        2. Physical activity

        3. Coaching

        4. Diet and exercise monitoring tool

      The program will be tailored to each individual participant. All participants will be ask to
      monitor their program using a tool provided by the study team. Participants will be actively
      participating in the study activities for about 5 months. After that, the study team will
      review medical records for up to 10 years after enrollment to monitor weight changes and
      cancer status.
    

Intervention name(s): Weight Loss Program; Standard of Care
Intervention type(s): Other; Other
Intervention description(s): Program has four main components: diet, physical activity, coaching and diet and exercise monitoring. The program is tailored to each individual in the study.; Standard of Care for this patient population.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: prostate cancer; prostatectomy; weight loss; prevent weight gain
Hydrating Efficacy and Tolerance Evaluation of a Face Cream
Condition: Dry and Damaged Skin
Study type: Interventional

Summary: 
      Aim of the study was to evaluate by non-invasive instrumental evaluations tolerance and
      hydrating activity of a face topic product, to be applied twice a day, morning and evening,
      for an uninterrupted period of 8 weeks, by volunteers of both sexes, aged 45-60, who meet the
      inclusion and exclusion criteria required by the study procedure .

      It was also aim of this study to evaluate the hydrating activity of a single product
      application on the skin damaged by repeated stripping corneum (short term evaluation versus
      untreated control area).
    


Intervention name(s): Jaluronius CS cream short term evaluation; Jaluronius CS cream long term evaluation
Intervention type(s): Other; Other
Intervention description(s): Short term evaluation to investigate the hydrating activity of a single application of the study product on the forearms (volar surface) after repeated stripping procedure,measured immediately after stripping execution (T0i), 1,8 and 24 hour/s after product application (T1h, T8h and T24h).; Long term evaluation to investigate the hydrating activity of the repeated application of the study product on the face (twice a day, for an uninterrupted period of 8 weeks), measured at basal visit (T0) and after 4 and 8 week-treatment (T4, T8)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment