bioihbjkbjnl/mcl2 huggingface dataset:
Comparative Efficacy, Safety, and Tolerability of Rivastigmine 10 and 15 cm^2 Patch in Patients With Alzheimer's Disease (AD) Showing Cognitive Decline
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Intervention: Rivastigmine 5 cm^2; Rivastigmine 10 cm^2; Rivastigmine 15 cm^2; Placebo to 15 cm^2 patch; Placebo to 10 cm^2 patch
Intervention description: 5 cm^2 transdermal patch; 10 cm^2 transdermal patch.; 15 cm^2 transdermal patch.; Placebo of rivastigmine transdermal patch 15 cm^2.; Placebo of rivastigmine transdermal patch 10 cm^2.
Intervention MeSH terms: Rivastigmine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1584.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Alzheimer's; Patch; Cognitive; Decline

Summary:

      The purpose of this study was to support the optimal use of rivastigmine patch in long-term
      treatment of Alzheimer's Disease in patients demonstrating functional and cognitive decline
      at the target maintenance dose of rivastigmine patch 10 cm^2.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients between 50 and 85 years of age with a diagnosis of probable
             Alzheimers Disease,

          -  Baseline Mini-Mental State Examination (MMSE) score 10-24 inclusive,

          -  A primary caregiver willing to accept responsibility for supervising treatment,
             assessing the patient's condition throughout the study, and for providing input into
             efficacy assessments.

          -  For double blind only: Meet the decline criteria of functional (as assessed by the
             investigator) and cognitive (assessed by a 1 point reduction in Mini-Mental State
             Examination) score between visits or a 3 point reduction from baseline) decline at
             weeks 23, 36 or 48.

        Exclusion Criteria:

          -  Presence of an advanced, severe, progressive, or unstable disease of any type that
             could interfere with efficacy and safety assessments or put the patient at particular
             risk,

          -  Any medical or neurological condition other than Alzheimers Disease that could explain
             the patient's dementia,

          -  A diagnosis of probable or possible vascular dementia,

          -  A current diagnosis of unsuccessfully-treated depression, or any other mental disorder
             that may interfere with the evaluation of the patient's response to study medication,

          -  A history or current diagnosis of cerebrovascular disease (e.g. stroke),

          -  A current diagnosis of severe or unstable cardiovascular disease (e.g. unstable
             coronary artery disease).

        Other protocol-defined inclusion/exclusion criteria may apply.
Safety and Efficacy of the GTS400 Stent in Conjunction With Cataract
Condition: Open-angle Glaucoma
MeSH terms: Glaucoma; Cataract; Glaucoma, Open-Angle
Intervention: Glaucoma Stent Surgery (GTS400 Stent); cataract surgery alone
Intervention description: ab interno trabecular bypass stent surgery; Cataract surgery alone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Open angle; Glaucoma; Cataract; Surgery

Summary:

      To evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400
      in conjunction with cataract surgery, compared to cataract surgery only, in subjects with
      mild to moderate open angle glaucoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Mild to moderate Open-Angle Glaucoma with specific criteria, in need of cataract
             surgery

          -  Subject willing to attend scheduled follow-up exams for two years postoperatively,
             Subject willing to provide written informed consent on the Institutional Review Board
             approved Informed Consent Form

        Exclusion Criteria:

        Not meeting inclusion criteria
A Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Trial 156-04-251 in Japan]
Condition: Autosomal Dominant Polycystic Kidney Disease （ADPKD)
MeSH terms: Arthrogryposis; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Intervention: tolvaptan
Intervention description: Repeated oral administration twice daily (morning and evening) at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg.
Intervention MeSH terms: Tolvaptan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 135.0
Sex: All
Minimum age: 23 Years
Maximum age: 53 Years
Healthy volunteers: No

Summary:

      ADPKD patients who enrolled in Trial 156-04-251 will receive repeated oral administration of
      tolvaptan twice daily (morning and evening: 45mg/15mg, 60mg/30mg, or 90mg/30mg).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who participated in Trial 156-04-251 in Japan and for whom CRF collection has
             been completed.

          -  Patients who completed 3-year repeated administration and who completed the second
             follow-up visit or patients whose treatment with the trial drug was interupted due to
             pregnancy and who completed out the second follow-up visit in Trial 156-04-251.

          -  Patients in whom any adverse events occurring in Trial 156-04-251 were resolved
             orstabilized and require no further follow-up.

        Exclusion Criteria:

          -  Patients with eGFR of less than 15 mL/min/1.73 m2

          -  Pregnant, breast-feeding, or possibly pregnant women or women who are planning to
             become pregnant

          -  Patients who received any investigational drug other than Tolvaptan within 30 days
             prior to commencement of administration of tolvaptan

          -  Any patients who, in the opinion of the principle investigator or subinvestigators,
             should not participate in the study
Rifamycin SV-MMX® Tablets Versus Ciprofloxacin Capsules in Acute Traveller's Diarrhoea
Condition: Traveler's Diarrhea
MeSH terms: Dysentery; Diarrhea
Intervention: Rifamycin SV-MMX®; Ciprofloxacin
Intervention description: 2 Rifamycin SV-MMX® 200 mg tablets and 1 placebo to ciprofloxacin capsule, b.i.d.; 1 ciprofloxacin 500 mg capsule and 2 placebos to Rifamycin SV-MMX® 200 mg tablets, b.i.d.
Intervention MeSH terms: Ciprofloxacin; Rifamycins; Rifamycin SV
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 835.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to prove the non-inferiority of Rifamycin SV-MMX® versus
      Ciprofloxacin for the treatment of adults with traveller's diarrhoea.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent,

          -  Men or women between 18 and 85 years of age,

          -  History of arriving from their country of residence in the industrialized part of the
             world within the past 4 weeks,

          -  Presenting with acute infectious diarrhoea (defined as at least 3 unformed, watery or
             soft stools accompanied by symptoms within 24 hours preceding randomisation with
             duration of illness ≤ 72 hours),

          -  Presence of one or more signs or symptoms of enteric infection (moderate to severe
             gas/flatulence, nausea, vomiting, abdominal cramps or pain, rectal tenesmus, fecal
             urgency),

          -  Women of childbearing potential had to apply during the entire duration of the study a
             highly effective method of birth control

        Exclusion Criteria:

          -  Residency in any country with high incidence rate of TD within the past 6 months,

          -  Fever (defined as a body (oral) temperature >100.4°F or 38.0°C; antipyretic medication
             should not have been administered in the 6 hours prior to this assessment),

          -  Known or suspected infection with non-bacterial pathogen,

          -  Presence of diarrhoea of >72 hours duration,

          -  Presence of grossly bloody stool,

          -  Presence of moderate or severe dehydration (i.e. symptoms of hypovolemia such as
             orthostatic hypotension, dizziness or wrinkling of skin),

          -  History of inflammatory bowel disease or celiac disease,
Welchol as Monotherapy for Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Welchol; Placebo
Intervention description: Welchol 625mg tablets; placebo
Intervention MeSH terms: Colesevelam Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 357.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The current study investigates Welchol as monotherapy to improve glycemic control in subjects
      with Type 2 Diabetes Mellitus not adequately controlled with diet and exercise alone. The
      study will evaluate if Welchol monotherapy for Type 2 Diabetes Mellitus will be safe, well
      tolerated and efficacious.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects >= 18 years of age;

          -  Women of childbearing potential (WOCBP) must be using an adequate method of
             contraception as detailed in the protocol.

          -  Diagnosis of Type 2 Diabetes Mellitus;

          -  HbA1C >= 7.5% and =< 9.5 % at screening;

          -  Fasting C-peptide >0.5 ng/mL at screening;

          -  Drug naïve (no prior treatment with OAD) or having received no pharmacologic therapy
             for diabetes for the 3 month period prior to screening;

          -  Clinically stable in regards to medical conditions other than type 2 diabetes;

          -  Concomitant medications must be at stable doses for at least 30 days prior to
             enrollment, and are not anticipated to need adjustment during the study period; and

          -  Fasting glucose =< 240 mg/dL at randomization

        Exclusion Criteria:

          -  A history of type 1 diabetes and/or a history of ketoacidosis;

          -  History of bowel obstruction;

          -  History of hypertriglyceridemia-induced pancreatitis;

          -  Fasting serum triglyceride concentrations >500 mg/dL;

          -  History of dysphagia, swallowing disorders, gastroparesis, other gastrointestinal (GI)
             motility disorders, or major GI surgery;

          -  History of insulin use of >= 2 weeks duration in the previous 3 months or a total of >
             2 months of insulin therapy at any time prior to screening;

          -  Two or more fasting self-monitored blood glucose (SMBG) levels >240 mg/dL during the
             placebo lead-in period.

          -  Previous treatment with a bile acid sequestrant, including Welchol within the 3 months
             prior to screening;

          -  Body mass index (BMI) >40 kg/m2;

          -  Weight loss > 3% in prior 3 months; and

          -  LDL <60 mg/dL.
Efficacy and Safety of Lomitapide in Japanese Patients With HoFH on Concurrent Lipid-Lowering Therapy
Condition: Familial Hypercholesterolemia - Homozygous
MeSH terms: Hyperlipoproteinemia Type II; Homozygous Familial Hypercholesterolemia; Hypercholesterolemia
Intervention: lomitapide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Study to Evaluate the Efficacy and Safety of Lomitapide in Japanese Patients with Homozygous
      Familial Hypercholesterolemia (HoFH) on Concurrent Lipid-Lowering Therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Japanese male and female patients aged ≥ 18 years of age who are receiving maximally
             tolerated, stable, lipid-lowering therapy

          2. Diagnosis of functional HoFH

          3. Body weight ≥ 40 kg and < 136 kg

          4. Negative pregnancy test at screening

        Exclusion Criteria:

          1. Uncontrolled hypertension

          2. History of chronic renal insufficiency

          3. History of biopsy proven cirrhosis or abnormal liver function tests (LFTs) at
             screening

          4. Any major surgical procedure occurring < 3 months prior to the screening visit

          5. Cardiac insufficiency

          6. Previous organ transplantation

          7. History of a non-skin malignancy within the previous 3 years

          8. Patients who are not able to limit their alcohol intake

          9. Participation in an investigational drug study within 6 weeks prior to the screening
             visit

         10. Known significant gastrointestinal bowel disease

         11. Nursing mothers

         12. Serious or unstable medical or psychological conditions

         13. Requirement for certain prohibited medications known to be potentially hepatotoxic

         14. Use of strong or moderate inhibitors of CYP3A4

         15. Use of simvastatin at doses >10 mg per day

         16. Documented diagnosis of any liver disease
Open-Label Extension Study of the Long-Term Effects of Migalastat HCL in Patients With Fabry Disease
Condition: Fabry Disease
MeSH terms: Fabry Disease
Intervention: migalastat HCl 150 mg
Intervention description: Migalastat HCl 150 mg (equivalent to 123 mg migalastat) was provided as capsules in blister packs. One capsule was taken orally every other day.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Amicus Therapeutics; Galafold; Migalastat; AT1001

Summary:

      This is an open-label extension study intended to provide continued treatment with migalastat
      hydrochloride (HCl) for participants with Fabry disease who completed treatment of a previous
      migalastat HCl study. The study assessed the long-term safety and effectiveness of migalastat
      HCl.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant had completed treatment in a previous study of migalastat HCl given as a
             monotherapy

          -  Male and female participant agreed to use protocol-identified acceptable contraception

          -  Participant was willing to provide written informed consent and authorization for use
             and disclosure of Personal Health Information (PHI)

        Exclusion Criteria:

          -  Participant's last available estimated glomerular filtration rate (eGFR) in the
             previous study was <30 milliliter (mL)/minute (min)/1.73 meters squared (m^2); unless
             there was measured GFR available within 3 months of Baseline Visit, which was >30
             mL/min/1.73 m^2

          -  Participant had undergone, or was scheduled to undergo kidney transplantation or was
             currently on dialysis

          -  Participant had a documented transient ischemic attack, stroke, unstable angina, or
             myocardial infarction within the 3 months before Baseline Visit

          -  Participant had clinically significant unstable cardiac disease in the opinion of the
             investigator (for example, cardiac disease requiring active management, such as
             symptomatic arrhythmia, unstable angina, or New York Heart Association class III or IV
             congestive heart failure)

          -  Participant had a history of allergy or sensitivity to AT1001 (including excipients)
             or other iminosugars (for example, miglustat, miglitol)

          -  Participant required treatment with Glyset® (miglitol) or Zavesca® (miglustat)

          -  Participants with severe or unsuitable concomitant medical condition

          -  Participants with clinically significant abnormal laboratory value(s) and/or
             clinically significant electrocardiogram (ECG) findings
A Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin
Condition: Hypertension; Hypercholesterolemia
MeSH terms: Hypertension; Hypercholesterolemia
Intervention: Amlodipine 2.5mg/Atorvastatin 5mg; Amlodipine 2.5mg/Atorvastatin 10mg; Amlodipine 5mg/Atorvastatin 5mg; Amlodipine 5mg/Atorvastatin 10mg
Intervention description: Single pill combination, dosed once daily for 8 weeks; Single pill combination, dosed once daily for 8 weeks; Single pill combination, dosed once daily for 8 weeks; Single pill combination, dosed once daily for 8 weeks
Intervention MeSH terms: Amlodipine; Atorvastatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 165.0
Sex: All
Minimum age: 20 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      To assess the changes in the trough Systolic Blood Pressure (SBP) and the percent changes in
      Low Density Lipoprotein-Cholesterol (LDL-C) from baseline at Week 8 in the treatment period
    

Eligibility criteria:

        Inclusion Criteria:

          -  The out-patient with concurrent hypertension and hyper-LDL-cholesterolemia is a male
             or female >=20 to <80 years of age at Visit 1.

          -  The SBP at Visit 4 (Week -1) and Visit 5 (Week 0) is continuously SBP >=140 mmHg and
             <180 mmHg,

          -  LDL-C >=140 mg/dL and <250 mg/dL at Visit 3 (Week -2) and 4 (Week -1).

        Exclusion Criteria:

          -  Subjects who had experienced the following coronary artery disease within the past 3
             months.

          -  Myocardial infarction

          -  Receiving PCI（percutaneous coronary intervention）or CABG (coronary artery bypass
             grafting)

          -  Any clinically meaningful valvular disease

          -  Subjects with a history of cerebrovascular diseases such as stroke or transient
             ischemic attack within the past 3 months.
Long-term Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Fingolimod 0.5 mg; Fingolimod 1.25 mg
Intervention description: Patients self-administered fingolimod 0.5 mg capsules orally once daily.; Patients self-administered fingolimod 1.25 mg capsules orally once daily.
Intervention MeSH terms: Fingolimod Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 920.0
Sex: All
Minimum age: 20 Years
Maximum age: 58 Years
Healthy volunteers: No
Keywords: Multiple sclerosis.; Relapse-remitting; Fingolimod

Summary:

      This extension study of was designed to evaluate the long-term safety, tolerability, and
      efficacy of fingolimod (FTY720) in patients with multiple sclerosis. The Extension study was
      an extension to the 24-month Core study (CFTY720D2301/NCT00289978).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients should complete the 24 month core study

        Exclusion Criteria:

          -  Patients with other chronic disease of the immune system, malignancies, acute
             pulmonary disease, cardiac failure, etc.

          -  Pregnant or nursing women

        Other protocol-defined inclusion/exclusion criteria may apply.
A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder
Condition: Autistic Disorder
MeSH terms: Autistic Disorder
Intervention: Aripiprazole
Intervention description: Flexibly dose administered orally once daily
Intervention MeSH terms: Aripiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 86.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Autistic Disorder, children and adolescents; aripiprazole; Long-term safety study; children and adolescents

Summary:

      The objective of this study is to investigate the safety and efficacy of aripiprazole orally
      administered over long term in subjects who complete a short-term treatment study of
      pediatric Autistic Disorder (031-11-002 study).
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient meets Autistic disorder diagnostic criteria defined in DSM-IV-TR.

          -  The patient has completed the 031-11-002 study (the patient has visited the hospital
             during week8)

          -  Inpatient or outpatient status

        Exclusion Criteria:

          -  The patient is currently diagnosed with another disorder on the autism spectrum in
             DSM-IV-TR, including Asperger's, Rett's Disorder, PDD-NOS, Childhood Disintegrative
             Disorder, or Fragile-X Syndrome.

          -  Patients who fall under a contraindication listed in the ABILIFY package insert

          -  Others
A Trial Comparing Moxifloxacin Versus Levofloxacin Plus Metronidazole In Uncomplicated Pelvic Inflammatory Disease
Condition: Pelvic Inflammatory Disease
MeSH terms: Pelvic Inflammatory Disease; Pelvic Infection
Intervention: Moxifloxacin (Avelox, BAY12-8039); Levofloxacin & Metronidazole
Intervention description: Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days; Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
Intervention MeSH terms: Moxifloxacin; Metronidazole; Levofloxacin; Norgestimate, ethinyl estradiol drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 460.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Uncomplicated pelvic inflammatory disease

Summary:

      To assess the efficacy and safety of oral moxifloxacin compared to oral levofloxacin plus
      oral metronidazole in uncomplicated pelvic inflammatory disease (PID)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of uncomplicated PID based on the absence of pelvic or tubo-ovarian abscess
             at pelvic ultrasound and/or laparoscopic examination.

        Exclusion Criteria:

          -  Subjects with impaired liver and renal function; known hypersensitivity to study
             drugs, related compounds or any of the excipients.