bioihbjkbjnl/mcl2 huggingface dataset:
Study to Test a Marketed Product in the Treatment of Migraine-associated Nausea
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Comparator: Rizatriptan; Comparator: Placebo
Intervention description: One dose Rizatriptan 10 mg orally disintegrating tablet / oral lyophilisate to treat one migraine attack.; One dose matching placebo to Rizatriptan to treat one migraine attack.
Intervention MeSH terms: Rizatriptan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 346.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Study to test the effectiveness of a marketed drug in the treatment of migraine-associated
      nausea.
    

Eligibility criteria:

        Inclusion Criteria:

          -  6-month history of migraine, moderate to severe migraine attacks with nausea, 1-6
             migraine attacks per month

        Exclusion Criteria:

          -  Heart disease, high blood pressure
Sofosbuvir + Ribavirin for 12 or 16 Weeks in Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection (FUSION)
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis C; Hepatitis C, Chronic
Intervention: SOF; RBV; Placebo to match SOF; Placebo to match RBV
Intervention description: Sofosbuvir (SOF) 400 mg tablet was administered orally once daily.; Ribavirin (RBV) tablets was administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).; Placebo to match SOF was administered orally once daily.; Placebo to match RBV was administered orally twice daily.
Intervention MeSH terms: Sofosbuvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 202.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HCV genotype 2 (GT-2); HCV genotype 3 (GT-3); HCV; Sustained Virologic Response; Direct Acting Antiviral; Combination Therapy; Treatment Experienced; GS-7977; Ribavirin

Summary:

      This study was to assess the safety and efficacy of sofosbuvir in combination with ribavirin
      (RBV) administered for 12 or 16 weeks in participants with genotypes 2 or 3 hepatitis C virus
      (HCV) infection as assessed by the proportion of participants with sustained virologic
      response (SVR) 12 weeks after discontinuation of therapy (SVR12).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Infection with HCV genotype 2 or 3

          -  Had cirrhosis determination

          -  Prior treatment failure

          -  Screening laboratory values within defined thresholds

          -  Subject had not been treated with any investigational drug or device within 30 days of
             the screening visit

          -  Use of highly effective contraception methods if female of childbearing potential or
             sexually active male

        Exclusion Criteria:

          -  Prior exposure to an direct-acting antiviral targeting the HCV nonstructural protein
             (NS)5B polymerase

          -  Pregnant or nursing female or male with pregnant female partner

          -  Current or prior history of clinical hepatic decompensation

          -  History of clinically significant illness or any other major medical disorder that may
             have interfered with subject treatment, assessment or compliance with the protocol

          -  Excessive alcohol ingestion or significant drug abuse
Assessment of the Safety and Efficacy Study of RGN-259 Ophthalmic Solutions for Neurotrophic Keratopathy : SEER-1
Condition: Neurotrophic Keratopathy
Intervention: RGN-259; Placebo
Intervention description: A preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into affected eye(s), five times a day for 4 weeks.; It is composed of the same excipients as RGN-259 but does not contain Tβ4
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Neurotrophic Keratopathy; NK

Summary:

      The objective of this study is to assess the safety and efficacy of RGN-259 Ophthalmic
      Solution compared to placebo for the treatment of NK.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be male or female of any race, at least 18 years of age

          -  Have provided verbal and written informed consent.

          -  Be able and willing to follow instructions, including participation in all study
             assessments and visits;

          -  Have stage 2 or 3 neurotrophic keratopathy in at least one eye If a female of
             childbearing potential, have a negative urine pregnancy test at Visit 1 and agree to
             use an adequate method of birth control throughout the study period.

        Exclusion Criteria:

          -  Have any clinically significant slit lamp findings at Visit 1 that in the opinion of
             the investigator may interfere with the study parameters;

          -  Have significant blepharitis, meibomian gland dysfunction (MGD), lid margin
             inflammation or active ocular allergy that requires treatment

          -  Have a lid function abnormality (ex. Lagophthalmos) which, in the opinion of the
             investigator, is the primary cause of the persistent epithelial defect;

          -  Be diagnosed with ongoing ocular infection (bacterial, viral or fungal) or active
             inflammation (e.g. follicular conjunctivitis) not related to NK

          -  Anticipate the use of fluoroquinolone-containing antibiotic eye drops during the
             study;

          -  Have used contact lenses (excluding therapeutic contact lenses) within 14 days prior
             to Visit 1 or anticipates use of contact lenses during the study period;

          -  Have an uncontrolled systemic disease that in the opinion of the investigator may
             interfere with the study parameters;

          -  Anticipate a change in immunosuppressive therapy during the course of the study;
Safety and Immunogenicity of Flublok Quadrivalent vs IIV4 in Adults 18-49 Years of Age
Condition: Influenza
Intervention: Flublok Quadrivalent; Inactivated Influenza Vaccine (IIV4)
Intervention description: Intramuscular injection of study vaccine; Intramuscular injection of study vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1350.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Randomized, double-blind trial of safety and immunogenicity of Flublok Quadrivalent versus
      Inactivated Influenza Vaccine (IIV4) in 1350 healthy, medically stable adults 18-49 years of
      age. Serum samples for Hemagglutinin Inhibition titers will be determined pre- and 28 days
      post-vaccination. Subjects will be followed for 6 months after vaccination for serious and/or
      medically-attended adverse events.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ambulatory, in good health or medically stable

          -  Able to understand and comply with planned study procedures

          -  Provide written informed consent

          -  Negative urine pregnancy test within 24 hours prior to vaccination (women of
             child-bearing potential)

        Exclusion Criteria:

          -  Prior serious or severe reaction to influenza vaccine

          -  Known contraindication to either study vaccine

          -  Receipt of any other influenza vaccine within 180 days prior to enrollment

          -  Plan to receive another licensed influenza or other vaccine during the duration of
             this study

          -  Receipt of any significant new diagnosis, medication (licensed or investigational), or
             licensed vaccine within 30 days prior to enrollment in this study

          -  Underlying disease or therapeutic intervention that might adversely affect the immune
             response

          -  Plans to participate in any investigation involving an investigational product during
             this study.

          -  Pregnant, lactating or planning to become pregnant within 30 days of study vaccine.

          -  Any clinical or social circumstance that in the opinion of the investigator could
             interfere with compliance with study procedures or interfere with the interpretation
ESSENCE Study: Efficacy and Safety of SD-101 Cream in Participants With Epidermolysis Bullosa
Condition: Epidermolysis Bullosa
MeSH terms: Epidermolysis Bullosa
Intervention: SD-101-6.0 cream; Placebo (SD-101-0.0) cream
Intervention description: applied topically once a day for 90 days; applied topically once a day for 90 days
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 169.0
Sex: All
Minimum age: 1 Month
Healthy volunteers: No
Keywords: Amicus Therapeutics; Scioderm, Inc.; Simplex; Recessive Dystrophic; Junctional non-Herlitz; Epidermolysis Bullosa; SD-101 6%; SD-101-6.0; Allantoin 6%; Zorblisa

Summary:

      The aim was to assess the efficacy and safety of SD-101-6.0 cream versus Placebo (SD-101-0.0)
      cream in the treatment of skin lesions in participants with Epidermolysis Bullosa. Funding
      Source - United States Food and Drug Administration (FDA) Office of Orphan Products
      Development (OOPD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed Consent form signed by the participant or participant's legal representative;
             if the participant was under the age of 18 but capable of providing assent, signed
             assent from the participant.

          -  Participant (or caretaker) must have been willing to comply with all protocol
             requirements.

          -  Diagnosis of Simplex, Recessive Dystrophic, or Junctional non-Herlitz EB.

          -  Participant must have had 1 target wound (size 10 to 50 cm^2) at study entry.

          -  Participants 1 month and older.

          -  Target wound must have been present for at least 21 days.

        Exclusion Criteria:

          -  Participants who did not meet the entry criteria outlined above.

          -  Selected target wound did not have clinical evidence of local infection.

          -  Use of any investigational drug within the 30 days before enrollment.

          -  Use of immunotherapy or cytotoxic chemotherapy within the 60 days before enrollment.

          -  Use of systemic or topical steroidal therapy within the 30 days before enrollment.
             (Inhaled steroids and ophthalmic drops containing steroids were allowed).

          -  Use of systemic antibiotics within the 7 days before enrollment.

          -  Current or former malignancy.

          -  Arterial or venous disorder resulting in ulcerated lesions.

          -  Pregnancy or breastfeeding during the study. (A urine pregnancy test was performed at
             screening and every 30 days until the final visit for female participants of
             childbearing potential).

          -  Females of childbearing potential who were not abstinent and not practicing a
             medically acceptable method of contraception.
A Study to Evaluate Oral Salmon Calcitonin in the Treatment of Osteoporosis in Postmenopausal Women Taking Calcium and Vitamin D
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: SMC021 Oral calcitonin; SMC021 Placebo
Intervention description: 0.8mg SMC021 - oral calcitonin, once daily; SMC021 - Placebo, once daily
Intervention MeSH terms: Calcitonin; Salmon calcitonin; Calcitonin Gene-Related Peptide; Katacalcin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 4665.0
Sex: Female
Minimum age: 55 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Osteoporosis, oral salmon calcitonin, treatment, efficacy, tolerability

Summary:

      The purpose of this Phase III study is to evaluate the efficacy and safety of oral salmon
      calcitonin in the treatment of patients with osteoporosis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal women with osteoporosis, ambulatory, in general good health, not
             receiving medication that affects bone metabolism, and free from any underlying
             condition, other than osteoporosis, that may result in abnormal bone metabolism.

        Exclusion Criteria:

          -  BMD T-score below -4.0 (based on absolute values g/cm2 as given in the protocol) at
             one or more of the measured sites

          -  More than 2 prevalent vertebral fractures (Genant et al, 15).

          -  If BMD is lower than -2.5 T-score at one or more of the measured sites, the
             participants will be excluded from the study, if they have a severe vertebral fracture
             (Genant et al, 15).

          -  Evidence of any clinical osteoporotic fracture and/or if they have a history of a
             clinical osteoporotic fracture (excluding wrist fractures)

          -  BMD T-score > -1.5 in all of the following regions: Lumbar spine, femoral neck or
             total hip.

        Other protocol defined inclusion/exclusion criteria may apply
Long-term Safety and Tolerability of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: TEV-48125; TEV-48125
Intervention description: TEV-48125 will be administered subcutaneously once every 4 weeks.; TEV-48125 will be administered subcutaneously once every 12 weeks.
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      To evaluate the long-term safety and tolerability of subcutaneous (SC) administration of
      TEV-48125 (at 225 mg once monthly [except for a loading dose of 675 mg for CM patients] or at
      675 mg every 3 months) for the preventive treatment of Chronic Migraine and Episodic Migraine
      patients
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has a history of migraine (according to The International Classification of
             Headache Disorders, third edition [beta version] criteria) or clinical judgment
             suggests a migraine diagnosis

          -  Patient fulfills the criteria for Chronic migraine or Episodic migraine in baseline
             information collected during the 28 day screening period

          -  Not using preventive migraine medications for migraine or other medical conditions or
             using no more than 2 preventive migraine medication for migraine or other medical
             conditions if the dose and regimen have been stable for at least 2 months prior to
             giving informed consent.

          -  Patient demonstrates compliance with the electronic headache diary during the
             screening period by entry of headache data on a minimum of 24 of 28 days and the
             entered data is judged appropriate by the investigator.

        Exclusion Criteria:

        - Hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary,
        neurologic, hepatic, or ocular disease considered clinically significant in the judgment of
        the investigator
Consistency Lots Vaccine Study (V260-009)
Condition: Rotavirus Infections
MeSH terms: Rotavirus Infections
Intervention: rotavirus vaccine, live, oral, pentavalent; Placebo
Intervention description: Three oral doses (~8.81 X 10^7 IU/Dose for Lot 1; ~8.01 X 10^7 IU/Dose for Lot 2; and ~6.91 X 10^7 IU/Dose for Lot 3) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination; Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10
weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 793.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study was designed to evaluate consistency in the antibody response to three
      manufactured lots of an investigational Rotavirus Vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy infants

        Exclusion Criteria:

          -  History of abdominal disorders from a birth defect, intussusception, or abdominal
             surgery

          -  Known or suspected problems with the immune system

          -  Fever at time of immunization

          -  Prior administration of a rotavirus vaccine

          -  History of known prior rotavirus disease, chronic diarrhea, or failure to thrive.
Evaluation of the Effect of Dapagliflozin in Combination With Metformin on Body Weight in Subjects With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Body Weight
Intervention: Dapagliflozin; Metformin; Sitagliptin; Placebo
Intervention description: Tablet oral 10 mg total daily dose once daily 102 weeks; Tablet oral 1500 - 2500 mg total daily dose 1-3 times a day104 weeks; Tablet oral 100 mg total daily dose once daily rescue medication; Matching placebo for dapagliflozin, tablet, oral, once daily, 102 weeks
Intervention MeSH terms: Metformin; Sitagliptin Phosphate; Dapagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 182.0
Sex: All
Minimum age: 30 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Dapagliflozin; Metformin; Type 2 diabetes; body weight

Summary:

      This study is being carried out to see if dapagliflozin in addition to metformin decreases
      body weight and if so, how it compares with metformin alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes

          -  Ongoing treatment with metformin on a stable dose of ≥1500 mg/day for at least 12
             weeks prior to enrolment

          -  Inadequate glycemic control, defined as HbA1c ≥6.5% and ≤8.5%

          -  ≥30 years for males

          -  ≥55 years for females

        Exclusion Criteria:

          -  Type 1 Diabetes

          -  Body weight change >5% within 3 months prior to enrolment

          -  Renal and liver impairment
Efficacy and Safety of Terbinafine Film Forming Solution in Patients With Tinea Pedis
Condition: Tinea Pedis
MeSH terms: Tinea; Tinea Pedis
Intervention: Terbinafine; Terbinafine Placebo
Intervention description: 1% single application; single application
Intervention MeSH terms: Terbinafine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 290.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Tinea pedis; Terbinafine film forming solution

Summary:

      This study will compare the efficacy and safety of a single dose of terbinafine film forming
      solution 1% with a single dose of placebo film forming solution in the treatment of tinea
      pedis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients ≥18 years of age with interdigital tinea pedis infection, with clinical
             diagnosis meeting required baseline total sign & symptom score and positive microscopy

        Exclusion Criteria:

          -  Allergy to the allylamine class of antimycotics or excipients in the formulation.

          -  Chronic, hyperkeratotic plantar (moccasin) tinea pedis

          -  Other fungal disease or intertrigo

          -  Other abnormal findings on the affected foot

          -  Systemic antifungal or antimicrobial treatment within the last 3 months

          -  Topical treatment for skin lesions on feet within the last 3 months

          -  Diabetes mellitus and peripheral artery occlusive disease
Effect of Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Tiotropium: The HELIOS Study (BY217/M2-128)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Roflumilast; Placebo
Intervention description: 500 µg, once daily, oral administration in the morning; once daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 743.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; Roflumilast

Summary:

      The aim of the study is to compare the efficacy of roflumilast to placebo on pulmonary
      function and symptomatic parameters in patients with chronic obstructive pulmonary disease
      (COPD) during concomitant administration of tiotropium. The study duration will last up to 28
      weeks. The study will provide further data on safety and tolerability of roflumilast.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  History of COPD for at least 12 months prior to baseline visit and chronic productive
             cough for 3 months in each of the 2 years prior to baseline visit

          -  FEV1/FVC ratio (post-bronchodilator) ≤ 70%

          -  FEV1 (post-bronchodilator) between ≥ 40% and ≤ 70% of predicted

          -  Treated with tiotropium for at least 3 months before enrollment

          -  At least 28 puffs of rescue medication during last week prior to randomization

        Main Exclusion Criteria:

          -  COPD exacerbation indicated by a treatment with systemic glucocorticosteroids and/or
             antibiotics not stopped at least 4 weeks prior to baseline visit