bioihbjkbjnl/mcl2 huggingface dataset:
The Clinical Acceptability of Unsedated Colonoscopy
Condition: Colonoscopy
Study type: Observational

Summary: 
      The study was aimed to prospectively evaluate the acceptance rate of unsedated colonoscopy,
      in a setting where routine sedation for colonoscopy is standard practice and to characterize
      the subset of patients willing to try and potentially completing an unsedated procedure.
    

Detailed description: 
      Patients were offered to undergo colonoscopy without routine premedication. In case of both
      acceptance and refusal, a brief questionnaire recording demographics (gender, age, level of
      education) and clinical features was prospectively recorded in a standard data sheet by one
      of the four endoscopists at enrollment. Clinical features recorded for each patient included:
      indication to the procedure, history of abdominal surgery or irritable bowel syndrome,
      presence of pain as main symptom, chronic use of sedative medications, level of patient's
      anxiety (none, mild, moderate or severe), main concern about the examination and reason for
      willing to attempt unsedated procedure.
    

Intervention name(s): Unsedated colonoscopy; Unsedated colonoscopy
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients were offered to undergo colonoscopy without routine premedication; Patients were offered to undergo unsedated procedure. Their demographics and clinical data were recorded
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        all consecutive 18-80 year-old outpatients presenting to undergo open-access colonoscopy
        for routine indications were considered eligible to enter the study.
Weight Loss and Cognitive Function in Adults
Condition: Overweight and Obesity
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      More than two-thirds of middle-aged and older adults are overweight, which places them at
      greater risk of disability and higher medical expenses. Lifestyle interventions which promote
      weight loss for this population are needed. However, it is not known how different weight
      loss approaches impact brain (cognitive) functions, such as memory and attention. The
      investigator's investigation aims to improve adherence to a hypocaloric diet prescription
      through improved attention and inhibitory control, reduced hunger, and increased satiety.

      The objectives of this pilot study are to: 1) determine the feasibility and establish
      proof-of-concept; 2) establish proficiency and feasibility of the proposed cognitive function
      assessments; and 3) obtain preliminary data for effect size generation.
    


Intervention name(s): Hypocaloric diet with hunger reduction strategy; Hypocaloric diet without hunger reduction strategy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will be counseled to consume a hypocaloric diet during the 4-week weight loss phase. Counseling will include specific instructions on a dietary manipulation which may reduce hunger, in order to facilitate dietary adherence.This will include tracking of the strategy. They will also be provided a pedometer and instructed to attain 10,000 steps per day.; Participants will be counseled to consume a hypocaloric diet during the 4-week weight loss phase. They will also be provided a pedometer and instructed to attain 10,000 steps per day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Weight loss; Cognitive function; Weight maintenance
Blueberry Consumption and Type 2 Diabetes
Condition: Type2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Lifestyle strategies that include dietary modification, such as consumption of a plant-based
      diet, are well recognized in disease prevention and may improve type 2 diabetes. Various
      components of a plant-based diet may contribute to its beneficial health effects, but there
      has been keen interest in the possibility that plant polyphenols may have a role. Blueberries
      are dietary sources of polyphenols, specifically anthocyanins. To date there are few human
      clinical trials evaluating the beneficial health effects of blueberries in populations with
      type 2 diabetes. The objective of the study is to determine if freeze-dried blueberries
      compared to a blueberry placebo will improve cardiometabolic parameters in men with type 2
      diabetes.
    


Intervention name(s): Blueberry; Placebo
Intervention type(s): Other; Other
Intervention description(s): 22 g freeze-dried whole blueberry powder; 22 g placebo blueberry powder
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Transcranial Direct Current Stimulation in Patients With Disorders of Consciousness
Condition: Disorder of Consciousness
MeSH terms: Consciousness Disorders
Study type: Interventional

Summary: 
      To date, several studies have focused on the use of transcranial direct current
      stimulation(tDCS) in patients with impaired consciousness.However,its therapeutic effects
      have been variously documented.So,in this study ,investigators explore the effects of tDCS.
    

Detailed description: 
      Background:tDCS was supposed as an experimental approach to disorders of consciousness
      treatment. Its therapeutic effects have been variously documented.

      Objective: The study aimed to investigate the reactivity of electroencephalography (EEG) and
      the clinical response of patients with disorders of consciousness and explore the
      neuromodulatory effects of highfrequency tDCS in DOC.

      Method:In this double-blind, randomized controlled trial,real or sham tDCS were applied to
      the left dorsolateral prefrontal (DLPF) cortex of participants with disorders of
      consciousness for two weeeks. Evaluations were blindly performed at baseline, immediately
      after the end of the 14-days treatment and 1 week later with the JFK Coma Recovery
      Scale-Revised (CRS-R) scale and EEG.
    

Intervention name(s): real tDCS; sham tDCS
Intervention type(s): Device; Device
Intervention description(s): Direct current was applied by a battery-driven constant current stimulator using saline-soaked surface sponge electrodes (7 3 5 cm) with the anode positioned over the left dorsolateral prefrontal cortex (F3 according to the 10-20 international system for EEG placement) and the cathode placed over the right supraorbital region. During real tDCS, the current was increased to 2 mA from the onset of stimulation and applied for 20 minutes.; For the sham condition(sham tDCS), the same electrode placement was used as in the stimulation condition, but the current was applied for only 5 seconds, and was then ramped down.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Using a sham-controlled randomized double-blind design, 20 patients were randomly assigned to either a real or sham stimulation group. Each intervention week included 10 daily sessions of 20-minute therapy with either anodal transcranial direct current stimulation (2 mA, 20 minutes; experimental group) or sham transcranial direct current stimulation (control group) over the left dorsolateral prefrontal cortex (DLPFC).
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tDCS; EEG
Relative Bioavailability Study of Solifenacin Succinate Liquid Suspension (Fed and Fasting) Versus VESIcare Tablet (Fasting) in Healthy Volunteers
Condition: Bioavailability of Solifenacin Succinate; Pharmacokinetics of Solifenacin Succinate; Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study is to compare the relative bioavailability and pharmacokinetics of
      solifenacin succinate suspension versus tablet.
    

Detailed description: 
      All subjects will participate in each treatment separated by a minimum (=> minimum) of 13
      days between dosing.

      In the two fasting periods, each subject will receive solifenacin succinate orally in each
      treatment period following a minimum 10 hour fast from food and beverages. In the fed
      condition, each subject will receive the suspension within 30 minutes of the start of
      breakfast.
    

Intervention name(s): solifenacin succinate suspension; solifenacin succinate tablet
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Oral
Other intervention name(s): YM905; VESIcare; YM905
Intervention MeSH terms: Solifenacin Succinate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: solifenacin succinate; VESIcare; Healthy Volunteers
Human Papillomavirus (HPV) Registration Study (Gardasil)(V501-023)(COMPLETED)
Condition: Papillomavirus Infections
MeSH terms: Papillomavirus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an immunogenicity and safety study of Gardasil (V501) in females 9 to 23 years of age
      in Korea.
    


Intervention name(s): Gardasil™; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6); Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
Other intervention name(s): V501
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Human Papilloma Virus
As Needed Beclomethasone/Salbutamol Combination in Single Inhaler for Mild Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to reveal that inhaled corticosteroid therapy combined with a
      short-acting beta2- agonist given on a symptom driven basis is as effective as traditional
      asthma therapy.

      Thus, three advantages will be achieved:

        1. better compliance with treatment since patients will most likely have to administer the
           treatment less frequently,

        2. maximum pharmacological effect with the least amount of drug and

        3. less economic burden on health care providers.
    

Detailed description: 
      Asthma is widely recognised as a chronic inflammatory disorder of the airways. The 1997
      American National Heart Lung and Blood Institute (NHLBI) Guidelines states that a firm
      scientific basis exists to indicate that asthma results from complex interactions among
      inflammatory cells, mediators and the cells and tissues resident in the airways.

      Despite the existence of effective therapy people still die from asthma. It is pertinent to
      state that the clinical effect of a drug is not only dependent on the specific action of the
      drug, but also on the patient's way of using it. Therefore, compliance is an important factor
      especially for chronic disorders such as asthma. Indeed, non compliance with asthma therapy
      is a serious problem. It has been reported that drug side effects, lifestyle, social and
      economic factors, method of drug delivery and dosing are factors that contribute to poor
      compliance. The consequences of poor compliance lead to increased morbidity due to increased
      symptoms and asthma exacerbation.

      The NHLBI Guidelines recommend daily treatment for patients with mild persistent asthma with
      inhaled glucocorticoids (200-500mcg/die) and short-acting bronchodilators as needed but no
      more than 3-4 times a day.

      Comparisons: beclomethasone dipropionate 250 mg combined with salbutamol 100 mg "as needed",
      vs salbutamol 100 mg alone "as needed", vs beclomethasone 250 mg twice a day plus salbutamol
      100 mg "as needed" and vs beclomethasone dipropionate 250 mg combined with salbutamol 100 mg
      twice a day plus salbutamol 100 mg "as needed", in the treatment of patients with mild
      persistent asthma.
    

Intervention name(s): beclomethasone/salbutamol combination; beclomethasone; salbutamol
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Beclomethasone; Albuterol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Anti-Asthmatic Agents; corticosteroids; symptom-driven; beclomethasone; salbutamol
The Caries-arresting Effect of Incorporating fTCP to NaF Varnish Applied Following AgNO3 in Preschool Children
Condition: Early Childhood Caries
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to compare the effectiveness of 25% AgNO3 solution plus 5% NaF
      varnish and 25% AgNO3 solution plus 5% NaF varnish with fTCP when applied semi-annually over
      30 months in arresting dentine caries of primary teeth among preschool children. Half of
      Participants will receive topical application of 25% AgNO3 solution and 5% NaF varnish, while
      the other half will receive topical application of 25% AgNO3 solution and 5% NaF varnish with
      fTCP.
    

Detailed description: 
      Aim:The objective of this study is to compare the effectiveness of commercially available of
      25% AgNO3 solution plus 5% NaF varnish and 25% AgNO3 solution plus 5% NaF varnish with fTCP
      when applied semi-annually over 30 months in arresting dentine caries of primary teeth among
      preschool children.

      Methods: The extension of the Consolidated Standards of Reporting Trials 2010 Statement will
      be followed for this 30-month, randomised, double-blinded, equivalence clinical trial.
      Approximately 2,000 kindergarten children will be screened and at least 376 children with
      caries will be recruited. This sample size is sufficient for an appropriate statistical
      analysis. The children will be randomly allocated into 2 groups to treat their caries over a
      30-month period: Group A - biannual application of a 25% AgNO3 solution followed by a 5% NaF
      varnish, and Group B - biannual application of a 25% AgNO3 solution followed by a 5% NaF
      varnish with functionalized tricalcium phosphate (fTCP).Clinical examinations will be
      conducted at 6-month intervals to assess whether the caries are arrested (primary outcome).
      Confounding factors such as oral hygiene habits will be collected through a parental
      questionnaire.

      Possible results and implications: As the first of its kind, this study would help to
      determine whether AgNO3 followed by 5% NaF varnish with and without fTCP are equivalent in
      arresting dentine caries of primary teeth in preschool children when applied semi-annually.
    

Intervention name(s): 25% AgNO3 solution followed by 5% NaF; 25% AgNO3 solution followed by 5% NaF with fTCP
Intervention type(s): Drug; Drug
Intervention description(s): Dosage: 25% AgNO3 solution 7.9mg(Ag+)/0.05ml (max dose), 5% NaF: 11.6mg (F-)/0.5ml (max dose).; Dosage: 25% AgNO3 solution 7.9mg(Ag+)/0.05ml (max dose), 5% NaF with fTCP: 11.6mg (F-)/0.5ml (max dose).
Other intervention name(s): 5% NaF without fTCP; 5% NaF with fTCP
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: silver nitrate; sodium fluoride; dental caries; equivalence trial
Evaluation of ContraMed VeraCept Intrauterine Copper Contraceptive for Long Acting Reversible Contraception
Condition: Contraception
Study type: Interventional
Phase: Phase 2

Summary: 
      Prospective, multi-center, single-arm, open-label, Phase II clinical study to evaluate the
      effectiveness, device placement, safety, and tolerability of VeraCept to support commencing a
      Phase III Clinical Study
    

Detailed description: 
      Up to 250 subjects will be consented, screened and have VeraCept placed, with a goal to have
      2240 evaluable cycles at 12 months. It is planned that 225 of the 250 subjects will be within
      the 18-35 year age range, with a total of 2015 evaluable cycles. The remaining 25 subjects
      will be within the 35-40 year age range.

      Follow-up: Physical assessment (office visit) will occur at weeks 6, 13, 26 and 52 after
      placement, with monthly telephone contact. For those subjects who wish to continue study
      device use after 12 months, follow-up office visits will occur every 6 months. Additional
      visits will be conducted if necessary for safety issues.

      Follow-up after early study device removal:

      Subjects requesting VeraCept removal to become pregnant will be followed to pregnancy or
      until the subject changes their mind about trying to get pregnant. All subjects in whom
      VeraCept is removed prior to 12 months, for any reason, will be required to use an
      alternative contraceptive for the first two weeks following removal. Progestin-only pills
      will be provided by the sponsor as a contraceptive option during this time unless the subject
      has a category 4 condition precluding their use.

      Study Population: Pre-menopausal women ages 18 - 40, at risk for pregnancy, who are
      interested in using an intrauterine contraceptive for birth control will be eligible for this
      study. Subjects must provide written informed consent and meet the study subject selection
      criteria without any exclusions as outlined in the Clinical Investigation Plan (CIP).

      Primary Effectiveness Outcome: The primary outcome measure is effectiveness, evaluated as the
      absence of pregnancy by 12 months, failure will be calculated by the Pearl Index.

      Safety and Other Outcome

      Measures: Safety and other outcome measures include:

      Study Device Placement:

        -  Ease of placement

        -  Placement success

      Safety:

        -  Serious Adverse Events

        -  Adverse Events

      Tolerability:

        -  Bleeding and spotting patterns

        -  Discontinuation rate and reasons for discontinuation
    

Intervention name(s): VeraCept
Intervention type(s): Device
Intervention description(s): IUD placement of VeraCept
Intervention model: Single Group Assignment
Intervention model description: VeraCept intrauterine contraceptive device
Masking: None (Open Label)
Primary purpose: Treatment
A Study of SENS 401 in Healthy Subjects
Condition: Inner Ear Disease
MeSH terms: Ear Diseases; Labyrinth Diseases; Labyrinthitis
Study type: Interventional
Phase: Phase 1

Summary: 
      Sensorion are the study sponsor and the objective of this study is to investigate the safety
      and pharmacokinetic (PK) profile of SENS 401 in humans after a single and repeat dose
      administration and to confirm that, there is no interconversion of the (R) enantiomer to the
      (S) enantiomer.

      The study only involves the one drug, referred to as SENS-401.The key objective is to assess
      the safety of SENS 401 after multiple doses in healthy subjects.

      The population who are eligible to take part in the study are healthy male and female,
      non-smoking volunteers, aged between 18 and 50 years, as determined by screening tests at
      Simbec.

      Participation in the trial will last for about 3 weeks (from first screening to final end of
      study visit).
    

Detailed description: 
      This is a randomised, double blind, multiple dose, safety and PK study. Three cohorts of 12
      subjects will be administered with three different dose regimens.

      Screening assessments will be carried out within 14 days before administration of the
      investigational medicinal product (IMP). Eligible subjects will be asked to return for the
      treatment period.

      Cohort 1: 12 subjects will receive 29 mg SENS-401 or placebo once daily for 7 days.

      Cohort 2: 12 subjects will receive 29 mg SENS-401 or placebo twice daily for 6 days and a
      single dose of 29 mg SENS-401 or placebo in the morning on Day 7.

      Cohort 3: 12 subjects will receive 43.5 mg SENS-401 or placebo twice daily for 6 days and a
      single dose of 43.5 mg SENS-401 or placebo in the morning on Day 7.

      Subjects will be asked to attend Simbec 5-7 days after administration of the last dose for a
      post study visit. If they are withdrawn from the study, they will still be asked to attend
      for an end of study assessment. Subjects may be asked to return again if we need to follow
      them up.
    

Intervention name(s): SENS-401; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral Administration; Oral Administration
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; Healthy Volunteer Study