bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Bowel Cleansing Efficacy Between Same-day Dose Versus Split Dose
Condition: Unrecognized Condition
Intervention: Polyethylene Glycol (PEG)
Intervention description: Different method for bowel cleansing using same bowel cleanser. Same-day dose group : 4L PEG will be ingested on the day of colonoscopy Spli-dose group : 2L PEG will be ingested 1 day before colonoscopy, remaining 2L PEG will be ingested on the day of colonoscopy
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 352.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Split dose bowel cleansing is recommended method for colonoscopy. For afternoon colonoscopy,
      same-day dose of bowel cleansing is alternative option. Recently, same-day bowel cleansing
      for morning colonoscopy was validated. To date, there was no study which compared the bowel
      cleansing efficacy between same-day dose and split dose regardless of colonoscopy time. The
      aim of current study is to compare the bowel cleansing efficacy, adverse events, and
      patient's tolerability between the two group.

      Subjects who underwent colonoscopy for various reasons were included. After agreeing to
      participate in the study, study participants were randomly assigned to split dose or same day
      dose group. Bowel cleansing is done using polyethylene glycol (PEG). All colonoscopy was done
      between 10 AM to 6 PM. Study participants were instructed to ingest 500ml PEG every 15
      minutes. Subjects who were assigned to split dose group ingested 2L PEG from 9PM 1 day before
      colonoscopy. Remaining 2L PEG was ingested 3-5 hours before colonoscopy. In the same-day dose
      group, bowel cleansing was started from 5AM for subjects who were scheduled to receive
      colonoscopy in the morning. Afternoon colonoscopy group in the same-day dose group ingested
      2L PEG from 5AM. Remaining 2L PEG was finished 3-5 hours before colonoscopy.

      Bowel cleansing efficacy was assessed using Boston bowel preparation scale. Vital signs and
      laboratory tests were checked before colonoscopy. Study participants completed questionnaire
      which contained patient's satisfaction, tolerability, and adverse event during bowel
      cleansing. Bowel cleansing efficacy, patient's tolerability, and safety profile were compared
      between the two groups. Successful bowel cleansing was estimated 85% for split dose group.

      The investigators set 10% for inferior margin. Considering 10% drop out, a total of 352
      subjects will be recruited.
    

Eligibility criteria:

        Inclusion Criteria:

          -  all subjects who undergo colonoscopy for various reasons.

        Exclusion Criteria:

          -  hemodynamic instability

          -  ileus or bowel obstruction

          -  active inflammatory bowel disease

          -  advanced colon cancer
Trial to Assess the Effects of Vorapaxar (SCH 530348; MK-5348) in Preventing Heart Attack and Stroke in Patients With Atherosclerosis (TRA 2°P - TIMI 50) (P04737)
Condition: Atherosclerosis; Ischemia; Myocardial Infarction; Cerebrovascular Accident; Peripheral Arterial Disease
MeSH terms: Stroke; Myocardial Infarction; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases; Infarction; Ischemia
Intervention: Vorapaxar; Placebo
Intervention description: 2.5-mg tablet daily for at least 1 year; matching tablet daily for at least 1 year
Intervention MeSH terms: Vorapaxar
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 26449.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study is designed to determine whether vorapaxar, when added to the existing standard of
      care (SOC) for preventing heart attack and stroke (eg, aspirin, clopidogrel) in participants
      with a known history of atherosclerosis, will yield additional benefit over the existing
      standard of care without vorapaxar in preventing heart attack and stroke.

      The study is also designed to assess risk of bleeding with vorapaxar added to the standard of
      care versus the standard of care alone.
    

Eligibility criteria:

        Inclusion Criteria:

        Men and women at least 18 years old with evidence or a history of atherosclerosis involving
        the coronary, cerebral, or peripheral vascular systems by one or more of the following:

          -  history of myocardial infarction (heart attack)

          -  history of ischemic stroke (stroke due to a blocked artery)

          -  history of peripheral arterial disease

        Exclusion Criteria:

          -  history of intracranial hemorrhage or of central nervous system (CNS) surgery, tumor,
             or aneurysm

          -  any bleeding disorder or abnormality

          -  sustained severe hypertension or valvular heart disease

          -  current or recent platelet count <100,000 mm^3

          -  planned or ongoing treatment with a blood thinning medication

          -  pregnancy

          -  any significant medical or physiological condition or abnormality that could put the
             subject at increased risk or limit the subject's ability to participate for the
             duration of the study
Phase 3 Clinical Trial of Teriparatide in Japan
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: Teriparatide; Placebo
Intervention description: daily, subcutaneous; daily, subcutaneous
Intervention MeSH terms: Teriparatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 207.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy of teriparatide based on measurements of bone mineral density at
      lumbar spine
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese patients diagnosed with osteoporosis

          -  Aged 55 or older

          -  Patients who are at high risk for fracture

        Exclusion Criteria:

          -  History of metabolic bone disorders other than primary osteoporosis

          -  History of malignant neoplasm in the 5 years, with the exception of superficial basal
             cell carcinoma or squamous cell carcinoma of the skin that has been definitively
             treated.

          -  Severe or chronically disabling conditions other than osteoporosis
Targeted Retreatment of COPD Exacerbations
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Ciprofloxacin; Placebo
Intervention description: 500 mg, twice daily for 1 week (oral); One capsule, twice daily for 1 week
Intervention MeSH terms: Ciprofloxacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 144.0
Sex: All
Minimum age: 45 Years
Healthy volunteers: No
Keywords: Chronic Obstructive Pulmonary Disease (COPD)

Summary:

      This study investigates the effects of targeted re-treatment of patients who do not recover
      from an exacerbation of COPD. Half of the patients will receive ciprofloxacin while the other
      half will receive a placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of COPD confirmed spirometrically at screening

          2. COPD exacerbation with treatment commenced 14 days prior to study enrolment and
             treated with 5-14 days of a non-quinolone antibiotic.

          3. Exacerbation here will be defined as an episode of symptomatic worsening of COPD that
             was treated by the patient's attending clinician. Confirmation of the initial
             exacerbation diagnosis will be provided from the case notes, referral letter, or
             directly from the treating clinician, and will be documented in the CRF.

          4. Age: ≥ 45 years of age at screening.

          5. Persistent symptoms and/or a CRP≥8mg/L when assessed 2 weeks after exacerbation onset

          6. Able to complete questionnaires for health status and symptoms and keep written diary
             cards

          7. Severity of disease: Patients with a measured FEV1<80% of predicted normal values at 2
             weeks post exacerbation

          8. Able and willing to give signed and dated written informed consent to participate.

        Exclusion Criteria:

          1. Other clinically predominant chronic respiratory disease.

          2. Intubated and receiving mechanical ventilation

          3. Patients with known hypersensitivity to the antibiotic under evaluation, to other
             quinolones or any excipients of the IMP/placebo.

          4. Patients with a prior history of tendonopathy or tendon rupture

          5. Elderly patients taking long term systemic corticosteroids

          6. Patients on long term antibiotics for other conditions

          7. Patient too unwell for randomisation, i.e. requiring retreatment in the judgment of
             the study doctor

          8. Female patients who are pregnant or planning on becoming pregnant during the study, or
             are breastfeeding.

          9. Patient taking clinically significant contraindicated medication as per the SmPC s,
             such as use of concomitant tizanidine or methotrexate.
Long Term Follow-up Study to Assess Durability of Sustained Virologic Response in Alisporivir-treated Hepatitis C Patients
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: Alisporivir
Intervention description: Intervention of interest; follow-up after ALV-active study
Phase: Phase 3
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 723.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic hepatitis C

Summary:

      The purpose of this study is to follow-up with participants from feeder studies who achieved
      sustained virologic response (SVR) over 24 hours posttreatment (SVR24), to assess durability
      of SVR, and to assess the changes in liver disease, development of hepatocellular carcinoma
      and post-treatment safety over time.

      Participants enter this study from feeder studies CDEB025A2210 (NCT01183169), CDEB025A2301
      (NCT01318694), and CDEB025A2211 (NCT01215643). They return to the site for up to 48 weeks
      with a maximum of 3 visits. No treatment is involved.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Provides written informed consent before any assessment is performed

          2. Is male or female aged ≥18

          3. Has previously completed a Novartis-sponsored hepatitis C study and received
             alisporivir

          4. Has achieved SVR24

          5. Is able to comply with the visit schedule

        Exclusion Criteria:

          1. Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days
             of that medication, whichever is longer.

          2. Use or planned use to start a new course of hepatitis C therapy.

          3. No additional exclusions are to be applied by the Investigator, in order to ensure
             that the study population is representative of all eligible patients.
A Double-blind, Randomized Conversion to Monotherapy Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥ 16 to 75 Years Old) With Partial Onset Seizures
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Intervention: Brivaracetam; Brivaracetam
Intervention description: 25 mg tablet - 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study); 25 mg tablet - 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study)
Intervention MeSH terms: Brivaracetam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 88.0
Sex: All
Minimum age: 16 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Epilepsy; Monotherapy; Partial Onset Seizures; Adults and Adolescents

Summary:

      Antiepileptic drugs (AEDs) are the main treatment for epilepsy; however, only a limited
      number of AEDs are approved for use as monotherapy. The objective of this study is to
      evaluate the efficacy of Brivaracetam (BRV) in the conversion of partial onset seizure
      patients from combination treatment to monotherapy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects from 16 to 75 years, both inclusive

          -  Well-characterized focal epilepsy or epileptic syndrome

          -  Subjects having at least 2 but not exceeding 40 partial onset seizures, whether or not
             secondarily generalized per 4 weeks during the 8-week Baseline Period

          -  Subjects on a stable dose of at least 1 but no more than 2 concomitant Antiepileptic
             Drugs (AEDs) with the second AED ≤ 50 % of the minimum recommended maintenance dose

        Exclusion Criteria:

          -  Seizure type IA non-motor as only seizure type

          -  History or presence of seizures occurring too frequently or indistinctly separated to
             be reliably counted during the 6 months preceding Visit 1 or during Baseline

          -  Other serious uncontrolled disease
Apixaban in Patients With Sickle Cell Disease
Condition: Vaso-occlusive Crisis; Reduction in Hospitalizations; Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Intervention: Apixaban; Placebo
Intervention description: Drug is taken by mouth twice a day for 6 months
Intervention MeSH terms: Apixaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Vaso-occlusive crisis; Reduction in hospitalizations; Sickle Cell Disease

Summary:

      In patients with SCD, the use of low dose anticoagulation as an outpatient may lead to a
      significant decrease in morbidity and as a result, decrease healthcare utilization and costs.
      This study attempts to critically avoid admissions by reducing daily pain scores and pain
      crisis as an outpatient by use of a novel oral anticoagulant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  documented HgbSS, SC or HgbS-beta0 thalassemia,

          -  age ≥18 years old and ≤80,

          -  seen in outpatient clinic ≥2 times in past year

          -  seen for an acute care visit (hospitalization, emergency department, or day hospital
             visit) for pain >2 times in the past year.

        Exclusion Criteria:

          -  Hospitalization or day hospital visit for pain crisis within the past 2 weeks

          -  Patients with ≥10 acute care visits within the past year will be excluded

          -  Creatinine >3.0 mg/dL

          -  creatinine ≥1.5 mg/dL AND weight ≤60 kg

          -  chronic use of antiplatelet or anticoagulation medication

          -  Patients with known vasculopathy or Moya-Moya

          -  platelet count <100 X 109/L

          -  AST or ALT >3 times normal

          -  chronic red blood cell transfusions (scheduled transfusions)

          -  packed red blood cell transfusion within the past 2 months

          -  Use of CYP3A4 and P-gp inhibitor medications
Study to Assess the Efficacy and Safety of Dysport® in Cervical Dystonia
Condition: Cervical Dystonia
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Intervention: Botulinum toxin type A
Intervention description: Active Drug: Botulinum type A toxin (Dysport®) 500 Units / 2.5 ml injected in muscles involved in cervical dystonia
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 516.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dysport, Cervical Dystonia

Summary:

      The aim is to demonstrate equivalent efficacy and safety in the treatment of the two most
      frequent forms of cervical dystonia (predominantly rotational torticollis and predominantly
      laterocollis) with the standard initial dose of 500 units Dysport®. The patients will be
      assigned to one of the two basic types of cervical dystonia, either predominantly rotational
      torticollis or predominantly laterocollis on the basis of clinical examination. This will
      determine which therapy is to be administered, using the clearly defined, structured
      injection protocols.
    

Eligibility criteria:

        Inclusion Criteria:

          -  De novo patients with cervical dystonia

          -  Outpatient

          -  Patients to be of age 18 years or older

          -  Written informed consent to participate in the study

        Exclusion Criteria:

          -  Pre-treatment of cervical dystonia with botulinum toxin

          -  Pre-treatment with botulinum toxin for any indication other than cervical dystonia
             within the past 12 months

          -  Pure retro- or antecollis

          -  Neurological or other diseases which may affect head and neck motor function or
             neuromuscular transmission, e.g. polyneuropathy with pareses, myasthenia, myopathy,
             motor neurone diseases, Bekhterev's disease
ATLAS: Ambulatory Treatments for Leakage Associated With Stress
Condition: Stress Urinary Incontinence; Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Intervention: Behavioral Therapy; Intravaginal Pessary; Pessary combined with behavioral therapy
Intervention description: Pelvic muscle training and exercises; Intravaginal pessary; Intravaginal pessary and behavioral therapy
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 445.0
Sex: Female
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Stress urinary incontinence

Summary:

      Stress urinary incontinence is the uncontrollable leakage of urine with physical effort or
      stress, such as coughing, sneezing, or exercise. Treatment for stress incontinence can be
      surgical or non-surgical. Different non-surgical treatments include pelvic muscle exercises
      and pessary use. Pelvic muscle exercises (often known as "Kegel" exercises) train and
      strengthen the pelvic muscles and improve incontinence. A pessary is a medical device that
      fits inside the vagina to give the urethra and bladder extra support and prevent or reduce
      urinary incontinence. Exercises and pessary use can help women with stress incontinence but
      it is not known which treatment is better, or if a combination of the two treatments at the
      same time is best. This study will determine whether pelvic muscle training and exercises,
      pessary use, or a combination of both exercises and pessary is most effective at improving
      incontinence in women. The study's primary hypothesis is that pessary use is more effective
      than pelvic muscle exercises after 3 months of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stress urinary incontinence or stress-predominant mixed urinary incontinence, with at
             least 2 episodes of stress incontinence on 7-day bladder diary and the number of
             stress incontinence episodes exceeding the number of urge incontinence episodes.

          -  Urinary incontinence for at least three months.

          -  Ambulatory adult women.

          -  Stage 0-I-II pelvic organ prolapse.

        Exclusion Criteria:

          -  Continual urine leakage.

          -  Pregnancy or planning pregnancy within 1 year.

          -  Active urinary tract infection.

          -  Urinary retention.

          -  Currently on medication for incontinence.

          -  Currently using a pessary.

          -  Neurologic condition that affects bladder function.
Sequential Treatment of Postmenopausal Women With Primary Osteoporosis (FP-001-IM)
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: Parathyroid Hormone (PTH); Risedronate
Intervention description: Self-administered (100 μg in a volume of 71.4 μL) daily as a subcutaneous injection in the abdomen using the Preotact pen.; Orally once weekly as one 35 mg tablet.
Intervention MeSH terms: Risedronic Acid; Hormones; Parathyroid Hormone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 407.0
Sex: Female
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Lumbar Spine Bone Mineral Density (BMD)

Summary:

      The objective is to show superior efficacy of PTH (1-84) over risedronate in treating
      osteoporotic women for 12 months after having previously been treated with PTH (1-84) for 12
      months followed by 12 months treatment with risedronate.
    

Eligibility criteria:

        Inclusion Criteria:

        Women above the age of 50 years with the diagnosis of postmenopausal primary osteoporosis
        may be enrolled in the trial if the following inclusion/exclusion criteria apply.

        All inclusion criteria must be answered "yes" for a subject to be enrolled in the trial.

          1. Has the subject given informed consent according to local requirements before any
             trial related activities? (A trial related activity is any procedure that would not
             have been performed during the routine management of the subject).

          2. Is the subject above 50 years old?

          3. Is the subject postmenopausal (more than 5 years) - in the judgement of the
             investigator?

          4. Does the subject have primary osteoporosis with a lumbar spine T score < -3.0 SD (at
             lumbar spine L1-L4, with a minimum of two evaluable vertebrae)?

          5. Does the subject have a life expectancy of >3 years?

          6. Is the subject able to self-inject PTH (1-84), (or to have PTH (1-84) injection by a
             helper)?