bioihbjkbjnl/mcl2 huggingface dataset:
A Trial to Compare Xifaxan to Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)
Condition: Clostridium Infections; Diarrhea
MeSH terms: Clostridium Infections; Diarrhea
Intervention: Rifaximin (Xifaxan); Vancomycin
Intervention MeSH terms: Vancomycin; Rifaximin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 237.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Clostridium difficile-associated Diarrhea (CDAD); CDAD; C diff

Summary:

      The purpose of this study is to assess the treatment and safety of a 10-day course of
      rifaximin (Xifaxan) as compared to vancomycin for treatment of Clostridium
      difficile-associated diarrhea (CDAD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is 18 years of age or older, has acute diarrhea and at least 1 other sign of
             enteric infection present, such as fever, nausea/loss of appetite, vomiting, severe
             abdominal pain or discomfort.

          -  Subject has a positive Clostridium difficile stool toxin assay at screening

        Exclusion Criteria:

          -  Subject has had a previous episode of clinically diagnosed Clostridium difficile
             within the past 6 months.

          -  Subject has chronic diseases associated with diarrhea (e.g., inflammatory bowel
             disease or diarrhea predominant irritable bowel syndrome [DIBS])

          -  Subject has had any therapy with any agent administered for the treatment of
             Clostridium difficile prior to randomization.
Safety/Efficacy of Zoledronic Acid and Alendronate on Bone Metabolism in Postmenopausal Women With Osteoporosis
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: Zoledronic acid 5 mg solution; Alendronate 70 mg tablets; Calcium/Vitamin D
Intervention description: Zoledronic acid was supplied as a concentrate of 5.33 mg zoledronic acid monohydrate in a 100 ml solution. 5.33 mg zoledronic acid monohydrate equals 5 mg zoledronic acid.; Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal.; Combined elemental calcium / vitamin D chewable tablets. Participants took 2 tablets a day, for a daily dose of calcium 1200 mg/vitamin D 800 IU.
Intervention MeSH terms: Vitamin D; Zoledronic Acid; Alendronate; Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 604.0
Sex: Female
Minimum age: 55 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: osteoporosis; bisphosphonate; biomarker; zoledronic acid; alendronate; postmenopausal

Summary:

      The aim of this study was to examine the effect of zoledronic acid and alendronate on bone
      metabolism as measured by biomarkers in postmenopausal women with osteoporosis.
    

Eligibility criteria:

        Inclusion Criteria:

        - Low bone mineral density (as indicated by a "t-score" of -2.0 or lower) postmenopausal
        women

        Exclusion Criteria:

        - Previous use of oral and iv bisphosphonates, parathormone, strontium ranelate, sodium
        fluoride.

        Other protocol-defined inclusion/exclusion criteria applied to the study.
A Clinical Trial Evaluating Efficacy and Safety of MC2-01 Cream
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Intervention: MC2-01 cream; Cal/BDP combination; Cream vehicle
Intervention description: MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream; calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%; Vehicle Cream
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 794.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is a randomized, investigator-blind, multicentre, vehicle- and
      comparator-controlled, parallel-group trial with the purpose of evaluating efficacy, safety
      and convenience of the MC2-01 cream.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provided written informed consent

          -  Generally healthy males or non-pregnant females, of any race or ethnicity, who are at
             least 18 years of age at the time of screening

          -  Have a clinical diagnosis of plaque psoriasis (psoriasis vulgaris) of at least 6
             months duration that involves the trunk and/or limbs that is amenable to topical
             treatment with a maximum of 100 g of trial medication per week

          -  Have a PGA of disease severity of mild or moderate on the body (trunk and/or limbs)

          -  An mPASI score of at least 2

          -  Have a treatment area involving 2- 30% of the body surface area (BSA)

        Exclusion Criteria:

          -  Current diagnosis of unstable forms of psoriasis

          -  Other inflammatory skin disease in the treatment area that may confound the evaluation
             of the psoriasis vulgaris

          -  Presence of pigmentation, extensive scarring, pigmented lesions or sunburn in the
             treatment areas

          -  Planned exposure to either natural or artificial sunlight

          -  History of hypersensitivity to any component of the test product or reference product

          -  Current or past history of hypercalcemia, vitamin D toxicity, severe renal
             insufficiency, or severe hepatic disorders

          -  Systemic treatment with biological therapies

          -  Use of systemic treatments that suppress the immune system and other systemic
             chemotherapeutic antineoplastic therapy within 4 weeks prior to the baseline visit and
             during the trial

          -  Use of phototherapy within 4 weeks prior to Visit 1/Baseline and during the trial;

          -  Use of topical treatments, except for emollients and non-medicated shampoos, with a
             possible effect on psoriasis within 2 weeks prior to Visit 1/Baseline

          -  Clinical signs of skin infection with bacteria, viruses, or fungi

          -  Known Human Immunodeficiency Virus (HIV) infection

          -  Any chronic or acute medical condition that may pose a risk to the safety of the
             subject, or may interfere with the assessment of safety or efficacy in this trial
Efficacy and Safety Study of BCX7353 as an Oral Treatment for the Prevention of Attacks in HAE
Condition: Hereditary Angioedema; HAE
MeSH terms: Angioedema; Angioedemas, Hereditary
Intervention: BCX7353 capsules; Placebo oral capsule
Intervention description: BCX7353 oral capsules administered once daily; Matching oral capsules administered once daily
Intervention MeSH terms: Berotralstat
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Only Part 1 and Part 2 were blinded. As part 3 was open-label, no blinding was used
Enrollment: 121.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: BCX7353; Berotralstat

Summary:

      This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial to
      evaluate the efficacy and safety of oral BCX7353 in preventing acute angioedema attacks in
      patients with Type I and Type II HAE.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  A clinical diagnosis of hereditary angioedema Type 1 or Type 2, defined as having a
             C1-INH functional level and a C4 level below the lower limit of the normal (LLN)
             reference range, as assessed during the Screening period.

          -  Subject weight of ≥ 40 kg

          -  Access to and ability to use one or more acute medications approved by the relevant
             competent authority for the treatment of acute attacks of HAE

          -  Subjects must be medically appropriate for on-demand treatment as the sole medicinal
             management for their HAE during the study.

          -  Subjects must have a specified number of investigator-confirmed attacks during the
             run-in period of a maximum of 56 days from the Screening visit.

          -  Acceptable effective contraception

          -  Written informed consent

        Key Exclusion Criteria:

          -  Pregnancy or breast-feeding

          -  Any clinically significant medical condition or medical history that, in the opinion
             of the Investigator or Sponsor, would interfere with the subject's safety or ability
             to participate in the study

          -  Any laboratory parameter abnormality that, in the opinion of the Investigator, is
             clinically significant and relevant for this study

          -  Severe hypersensitivity to multiple medicinal products or severe hypersensitivity/
             anaphylaxis with unclear etiology

          -  Use of C1-INH within 14 days or use of androgens or tranexamic acid within 28 days
             prior to the Screening visit for prophylaxis of HAE attacks, or initiation of these
             drugs during the study

          -  Current participation in any other investigational drug study or received another
             investigational drug within 30 days of the Screening visit

          -  Prior enrollment in a BCX7353 study
Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa in China
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: rasagiline; placebo
Intervention description: 1 mg/day, tablets, once daily, orally; tablets, once daily, orally
Intervention MeSH terms: Rasagiline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 130.0
Sex: All
Minimum age: 35 Years
Healthy volunteers: No
Keywords: Rasagiline; Azilect; Parkinson´s Disease; Motor fluctuations

Summary:

      Rasagiline has been developed for the treatment of Parkinson's Disease (PD), as monotherapy
      in early PD patients not treated with levodopa, and as adjunct therapy to levodopa in
      levodopa-treated PD patients with motor fluctuations.

      The rationale for conducting this study is to evaluate the efficacy, tolerability, and safety
      of rasagiline compared to placebo in Chinese PD patients not treated with levodopa.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with idiopathic PD.

          -  Patients with a Modified Hoehn and Yahr stage <3.

        Exclusion Criteria:

          -  Patients with a clinically significant or unstable medical or surgical condition that
             would preclude his/her safe and complete study participation.

          -  Patients with a clinically significant or unstable vascular disease.

          -  Patients with a clinically significant psychiatric illness, including a major
             depression, which compromises their ability to provide consent or participate fully in
             the study.

          -  Patients with a Mini Mental State Examination (MMSE) score ≤24.

          -  Patients with a diagnosis of melanoma or a history of melanoma, or a suspicious
             lesion.

        Other inclusion and exclusion criteria may apply.
AR101 Real-World Open-Label Extension Study
Condition: Peanut Allergy
MeSH terms: Hypersensitivity; Peanut Hypersensitivity
Intervention: AR101
Intervention description: AR101
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 243.0
Sex: All
Minimum age: 4 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: AR101; Characterized Peanut Allergen; CPNA (Characterized Peanut Allergen); OIT (oral immunotherapy); Peanut Allergy; Peanut-Allergic Children; Desensitization; Food Allergy

Summary:

      This study is enrolling participants by invitation only. This is an open-label, safety
      extension study for subjects who participated in the ARC007 study.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Received AR101 in study ARC007

          -  Completed the ARC007 study

          -  Use of effective birth control by sexually active female subjects of childbearing
             potential

        Key Exclusion Criteria:

          -  Developed a clinically significant change in health status during the ARC007 study
             which in the opinion of the investigator would make the subject unsuitable for
             participation in this study.

          -  Receiving a prohibited medication or anticipated use of a prohibited medication [e.g.,
             angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers or calcium
             channel blockers], any monoclonal antibody, any investigational peanut immunotherapy,
             or any other immunomodulatory therapy.

          -  Currently in the build-up phase of immunotherapy for any nonfood allergen.

          -  Currently participating in any other interventional clinical study outside of the
             ARC007 study that was just completed.
The Role of Biodentine in Class V Dental Lesions on Oral Health Related Quality of Life
Condition: Quality of Life; Cervical Abrasion
Intervention: Photac-fil; Biodentine
Intervention description: Application of a tooth colored filling in a non-cavitated dental lesion.; Application of a white colored filling in a non-cavitated dental lesion.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: One group will be treated with a tooth colored filling that will be placed near the gum line. The second group will be treated with a white colored filling that will be placed near the gum line.
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      The study will compare two different dental materials on dental lesions near the gum line
      that cause chronic pain on oral health related quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females age 18-64

          -  Chief complaint associated with pain from cold or hot

          -  Chronic sensitivity associated with supragingival lesions

          -  Pain not associated with decay

          -  Fluent in English and able to read English at a 6th grade level

          -  Pulpal response <40 via pulp tester

          -  Active salivary flow from palpation of parotid and submandibular glands

          -  Patients self reporting pain over 6/10 in the past week and/or the past 2 months

        Exclusion Criteria:

          -  Pregnant women

          -  Patients taking benzodiazepines, narcotics and multiple antidepressants for pain
             management not associated with the oral cavity

          -  Unexplained dry mouth

          -  Patients taking two or more medications associated with dry mouth

          -  Pulpal response >40 via pulp tester

          -  Patients requiring treatment for more than 5 decayed sites, periodontal disease and
             root canal therapy

          -  Complicated medical history (>4 concurrent treatment for systemic diseases)

          -  Lesion >1mm below the gum line
CANVAS - CANagliflozin cardioVascular Assessment Study
Condition: Diabetes Mellitus, Type 2; Cardiovascular Diseases; Risk Factors
MeSH terms: Cardiovascular Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo; Canagliflozin (JNJ-28431754) 100 mg; Canagliflozin (JNJ-28431754) 300 mg
Intervention description: One placebo capsule taken orally (by mouth) once daily; One 100 mg capsule taken orally (by mouth) once daily; One 300 mg capsule taken orally (by mouth) once daily
Intervention MeSH terms: Canagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 4330.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: Diabetes; Type 2 diabetes mellitus; Cardiovascular risk; Cardiovascular outcomes; Canagliflozin (JNJ-28431754); Placebo

Summary:

      The study will assess canagliflozin (JNJ-28431754) in the treatment of patients with type 2
      diabetes mellitus (T2DM) with regard to cardiovascular (CV) risk for major adverse cardiac
      events (MACE). Other objectives include evaluating the overall safety, tolerability, and
      effectiveness of canagliflozin.

      The data from this study will be combined with the data from CANVAS-R study (Study of the
      Effects of Canagliflozin on Renal Endpoints in Adult Subjects with T2DM, NCT01989754) in a
      pre-specified integrated analysis of CV safety outcomes to satisfy US FDA post-marketing
      requirements for canagliflozin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have a diagnosis of type 2 diabetes mellitus and greater than or equal
             to (>=) 30 yrs old with history of cardiovascular (CV) event, or >= 50 yrs old with
             high risk of CV events

          -  Patients must have inadequate diabetes control (as defined by glycosylated hemoglobin
             greater than or equal to 7.0% to less than or equal to 10.5% at screening) and be
             either (1) not currently on diabetes drug therapy or (2) on therapy with any approved
             class of diabetes drugs

        Exclusion Criteria:

          -  A history of diabetic ketoacidosis, type 1 diabetes mellitus, pancreas or beta-cell
             transplantation, or diabetes secondary to pancreatitis or pancreatectomy

          -  History of one or more severe hypoglycemic (ie, very low blood sugar) episode within 6
             months before screening
A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002]
Condition: Autosomal Dominant Polycystic Kidney Disease
MeSH terms: Arthrogryposis; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Intervention: OPC-41061
Intervention description: Repeated oral administration at doses of 15 mg twice daily (morning and evening)
Intervention MeSH terms: Tolvaptan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Healthy volunteers: No
Keywords: ADPKD; Tolvaptan; OPC-41061

Summary:

      ADPKD patients who were enrolled in Study 156-05-002 will receive repeated oral
      administration of OPC-41061 at doses of 15 mg twice daily (morning and evening).
      Administration will be continued until the time of manufacturing and distribution approval of
      OPC-41061 for ADPKD in Japan.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who completed 3-year repeated administrations and the follow-up observation
             or those who were withdrawn from the study due to reasons other than occurrence of
             adverse events (based on the judgment of either the subject or the
             investigator/subinvestigator) in the preceding study (156-05-002)

          -  Patients in whom adverse events occurring in study 156-05-002 were resolved or became
             stable and do not require further follow-up.

        Exclusion Criteria:

          -  Patients with eGFR of less than 15 mL/min/1.73 m2

          -  Patients with any of the following complications:

               -  Uncontrolled hypertension

               -  Serious cardiovascular disease (eg. heart failure) or hepatic disease (eg.
                  cirrhosis)

          -  Patients with any of the following complications or history thereof:

               -  Clinically significant drug allergies (anaphylaxis) or hypersensitivity
                  (especially, hypersensitivity to benzazepine derivatives or suspected
                  hypersensitivity

               -  Inability to personally give consent due to a mental illness
Evaluation of Long-Term Efficacy of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia at High Cardiovascular Risk
Condition: Hypercholesterolemia; Atherosclerotic Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Atherosclerosis; Hypercholesterolemia; Hyperlipidemias; Hyperlipoproteinemias
Intervention: bempedoic acid; placebo
Intervention description: bempedoic acid 180 mg tablet taken orally, once daily. Patients remain on ongoing lipid-modifying therapy (not study provided); Matching placebo tablet taken orally, once daily. Patients remain on ongoing lipid-modifying therapy (not study provided)
Intervention MeSH terms: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 779.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hyperlipidemia; cholesterol; familial hypercholesterolemia; atherosclerotic cardiovascular disease; ASCVD; HeFH; LDL

Summary:

      The purpose of this study is to see if bemedoic acid (ETC-1002) is effective versus placebo
      in patients with high cardiovascular risk and elevated LDL cholesterol not adequately
      controlled by their current therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Fasting LDL-C ≥100 mg/dL

          -  High cardiovascular risk (diagnosis of HeFH and/or ASCVD)

          -  Be on maximally tolerated lipid-modifying therapy (LMT), including maximally tolerated
             statin either alone or in combination with other LMTs

        Exclusion Criteria:

          -  Total fasting triglyceride ≥500 mg/dL

          -  Renal dysfunction or nephrotic syndrome or history of nephritis

          -  Body Mass Index (BMI) ≥50kg/m2

          -  Significant cardiovascular disease or cardiovascular event in the past 3 months