bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Risedronate Therapy Administered 35 mg Once A Week in Men With Osteoporosis
Condition: Other Osteoporosis
MeSH terms: Osteoporosis
Intervention: Placebo tablet; Risedronate
Intervention description: one placebo once a week for two years followed by one 35 mg risedronate once a week for two years; one 35 mg risedronate once a week for two years followed by one 35 mg risedronate once a week for two years
Intervention MeSH terms: Risedronic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 285.0
Sex: Male
Minimum age: 30 Years
Healthy volunteers: No

Summary:

      Two year study to determine the safety and efficacy of weekly 35 mg Risedronate doses in men
      with osteoporosis followed by a two year follow-up study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented osteoporosis of the femoral neck and lumbar spine

        Exclusion Criteria:

          -  BMI greater than or equal to 35
A Study on the Use of Tanakan® for Recovery of Neurological Impairment Following Ischaemic Stroke
Condition: Stroke, Acute; Neurological Impairment
MeSH terms: Stroke; Ischemic Stroke
Intervention: EGb761; Placebo; Acetylsalicylic acid
Intervention description: EGb761 (Tanakan) 40 mg tablets (2 tablets t.i.d. (3 times a day)) 240 mg/day for 6 months.; Placebo 40 mg tablets (2 tablets t.i.d.) 240 mg/day for 6 months.; Acetylsalicylic acid 325 mg/day (1 tablet once daily), for 6 months.
Intervention MeSH terms: Aspirin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 204.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the effectiveness of Tanakan® 240mg in association
      with Acetylsalicylic acid (325mg/day) in the recovery of neurological impairment following
      ischemic stroke.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient having had a single infarct in the carotid artery territory 3 to 8 days before
             inclusion

          -  Patient with a moderately severe or severe disability (Modified Rankin Score 4 or 5)

          -  Patient having a Quick's Test (for INR) and APPT (activated partial prothrombin time)
             test in the normal values of the laboratory

        Exclusion Criteria:

          -  Patients having had an ischemic stroke (CT confirmed) less than 3 days and more than 8
             days prior

          -  Patient with known pre-existent cerebral infarction

          -  Infarct damaged area bigger than 1/3 hemisphere

          -  Patient having a score below the cut-off point at Frenchay Aphasia Short Test
Determining Long-Term Safety and Efficacy of Japanese Encephalitis Vaccine When Given With Measles Vaccine
Condition: Encephalitis, Japanese B
MeSH terms: Measles; Encephalitis, Japanese; Encephalitis
Intervention: Live attenuated SA 14-14-2 vaccine
Intervention description: Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Enrollment: 519.0
Sex: All
Minimum age: 20 Months
Maximum age: 36 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Japanese Encephalitis; Japanese B Encephalitis; Japanese B Viral Encephalitis; Viral Encephalitis, Japanese B

Summary:

      The previously conducted JEV01 study looked at the immunogenicity and safety of the
      concurrent administration of Japanese Live Attenuated SA 14-14-2 and measles vaccines at the
      one month post vaccination time point. The purpose of the JEV01 study was to help ensure the
      safety of SA 14-14-2 simultaneously administered with measles vaccine, paving the way for its
      use in routine EPI programs. As a follow-on to JEV01, this study will enroll those infants
      who received both vaccines and completed the JEV01 study. This study, however, will provide
      crucial data to help ensure the long-term immunogenicity of the concurrent administration of
      these vaccines and provide valuable information to determine the use of these vaccines in
      routine immunization programs. This study is planned because in the original protocol for
      JEV01, long-term data points were not included. The hypothesis is that children who receive
      JE live attenuated SA 14-14-2 vaccine and measles vaccine at the same time have long-term (24
      and 36 months post vaccination) protection against these diseases at the same level as those
      who receive the vaccines at different intervals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant was enrolled in the JEV01 study previously conducted at RITM.

          -  Participant completed his/her vaccination schedule for the JEV01 study previously
             conducted at RITM.

          -  Participant's blood test results from JEV01 study indicate that he/she had
             seroconverted to measles vaccination.

          -  Participant's parents or legal guardian are/is willing to provide signed informed
             consent.

        Exclusion Criteria:

          -  Participant was withdrawn from the JEV01 study for any reason.

          -  Receipt of immune globulin or other blood products within 6 months of study (JEV02)
             entry or receipt of injected or oral corticosteroids or other immune modulator therapy
             (except routine vaccines) within 4 weeks of study (JEV02) entry.

          -  Any condition that in the opinion of the investigator, would interfere with the
             evaluation of the study objectives.
Clinical Trial Ceftriaxone in Subjects With ALS
Condition: Amyotrophic Lateral Sclerosis; ALS
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Intervention: ceftriaxone; placebo
Intervention description: Participants will be randomly assigned to receive treatment with ceftriaxone or placebo for at least 12 months. Two thirds of participants will receive ceftriaxone and one third will receive placebo. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.
Ceftriaxone is approved by the U.S. Food and Drug Administration (FDA) for treating bacterial infections but not for treating ALS. Also, ceftriaxone has not been given to people over a long period of time, such as months or years.; an inactive substance
Intervention MeSH terms: Ceftriaxone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 513.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: amyotrophic lateral sclerosis; ALS; ceftriaxone; cephalosporin antibiotic; motor neurons

Summary:

      The purpose of the study is to evaluate the safety and efficacy of ceftriaxone treatment in
      amyotrophic lateral sclerosis (ALS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants will be people with ALS, at least 18 years of age.

          -  Participants must be medically able to undergo the study procedures and have a
             caregiver or other individual who will be available to help with daily study
             medication administration.

          -  Participants should live within a reasonable distance of the study site, due to
             frequent study visits.

        Exclusion Criteria:

          -  Participants cannot be taking any other experimental medications for ALS, or have a
             history of sensitivity to cephalosporin antibiotics (such as Ancef, Keflex, Ceclor,
             Ceftin, Lorabid, Suprax, or Fortaz).
Study of Travoprost Ophthalmic Solution, 0.004% Compared to Timolol (0.5% or 0.25%) in Pediatric Glaucoma Patients
Condition: Pediatric Glaucoma; Elevated IOP in Pediatric Patients; Ocular Hypertension in Pediatric Patients
MeSH terms: Glaucoma; Ocular Hypertension; Hydrophthalmos
Intervention: Travoprost 0.004% PQ ophthalmic solution; Timolol, 0.5% or 0.25% ophthalmic solution; Travoprost Vehicle
Intervention description: Patients 2 months to < 3 years of age received 0.25%; Inactive ingredients used to maintain masking
Intervention MeSH terms: Timolol; Travoprost; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 184.0
Sex: All
Minimum age: 2 Months
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the intraocular pressure (IOP)-lowering efficacy of
      Travoprost 0.004% POLYQUAD (PQ) ophthalmic solution compared to Timolol ophthalmic solution
      (0.5% or 0.25%) in pediatric glaucoma patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of pediatric glaucoma or ocular hypertension.

          -  Qualifying mean IOP at the Eligibility Visit in at least one eye.

          -  Written informed consent, including assent when applicable, MUST be obtained from the
             parent or legally authorized representative prior to any procedure specified in the
             protocol, including screening procedures.

          -  Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  Females of childbearing potential who are pregnant, intend to become pregnant during
             the study period, breast feeding, or not using any form of birth control measures.

          -  History of chronic, recurrent or severe inflammatory eye disease.

          -  Ocular trauma requiring medical attention within the past 3 months prior to the
             Screening Visit.

          -  Ocular infection or ocular inflammation within the past 30 days prior to the Screening
             Visit.

          -  Clinically significant or progressive retinal disease.

          -  Severe ocular pathology (including severe dry eye) that, in the opinion of the
             Investigator, would preclude the administration of a topical prostaglandin analog or a
             topical beta-blocker.

          -  Intraocular surgery in the study eye within 30 days prior to the Screening Visit.

          -  Any abnormality preventing reliable applanation tonometry.

          -  Other protocol-defined exclusion criteria may apply.
Effect of D-cycloserine Plus Cognitive Behavioral Therapy on People With Social Phobia
Condition: Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Intervention: D-cycloserine; Cognitive behavioral therapy (CBT); Placebo
Intervention description: 50 mg; CBT sessions aim to help participants become more comfortable with social situations.; Same dosage as active pill
Intervention MeSH terms: Cycloserine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 169.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Generalized subtype

Summary:

      This study will assess the effectiveness of D-cycloserine combined with cognitive-behavior
      therapy in treating people with social anxiety disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets DSM-IV criteria for generalized social anxiety disorder (GSAD)

          -  Total score of greater than or equal to 60 on the LSAS

          -  Physical examination, electrocardiogram, and laboratory findings without clinically
             significant abnormalities

        Exclusion Criteria:

          -  Lifetime history of bipolar disorder, schizophrenia, psychosis, delusional disorders,
             or obsessive-compulsive disorder

          -  Eating disorder within the 6 months prior to study entry

          -  History of organic brain syndrome, mental retardation, or other cognitive dysfunction

          -  Substance or alcohol abuse or dependence (other than nicotine) within the 6 months
             prior to study entry or inability to refrain from alcohol use during the acute period
             of study participation

          -  Post-traumatic stress disorder within 6 months prior to study entry; entry of patients
             with other mood or anxiety disorders will be permitted if the social anxiety disorder
             is judged to be the predominant disorder

          -  Suicidal thoughts

          -  Taking concurrent psychotropic medication (e.g., antidepressants, anxiolytics, beta
             blockers) within 2 weeks of study entry

          -  Significant personality dysfunction

          -  Serious medical illness or instability for which hospitalization may be likely within
             the next year
A Randomized Trial of Medi-Cal Beneficiaries Calling the California Smokers' Helpline
Condition: Smoking Cessation
Intervention: Telephone counseling; Nicotine patches; Incentive
Intervention description: Telephone counseling is conducted in the appropriate language (Spanish and English) by counselors at the California Smokers' Helpline. Counselors use a structured protocol and there is a record for each call. Quantitative information that will be available for analysis include: timing, length, and frequency of counseling calls.; Clients will be screened for contraindications to nicotine patch use, and a doctor's approval will be necessary before patches are sent if a contraindication exists.; They will be given their choice of gift cards from one of 4 major business chains: Wal-Mart, Target, Vons/Safeway, or Ralph's/Kroger card.
Intervention MeSH terms: Nicotine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3816.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Smoking cessation; Telephone; Self-help; Smoking abstinence; Incentives; Nicotine-replacement therapy; Medi-Cal; Medicaid

Summary:

      California Smokers' Helpline will conduct a randomized trial to evaluate 3 strategies of
      services and/or incentives on smoking cessation rates. This project has the following
      specific aims:

        1. To increase tobacco cessation among Medi-Cal beneficiaries who currently smoke, and to
           improve the management of diabetes and other chronic disease by means of tobacco
           cessation.

        2. Demonstrate that tobacco cessation benefits that are well promoted and barrier free and
           include modest incentives, are effective in reducing smoking prevalence, lowering
           Medi-Cal health care costs, and improving health outcomes for diabetes management in
           particular.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years or older

          -  Medi-Cal beneficiary with valid Medi-Cal beneficiary ID

          -  Willing to link Helpline data with Medi-Cal utilization data

          -  English or Spanish speaking

          -  Valid phone number

          -  Valid address

          -  Gave consent to participate in study and evaluation

        Exclusion Criteria:

          -  Contraindication(s) to nicotine patches and no MD approval

          -  Pregnant
SVT-15652 Otic Solution for the Treatment of Otomycosis.
Condition: Otomycosis
MeSH terms: Otomycosis
Intervention: SVT-15652; Placebo
Intervention description: 1 vial twice daily; 1 vial twice daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 194.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Multicenter, randomized, 2-arm parallel-group, double blind, placebo-controlled study in
      patients suffering from Otomycosis. This study will compare the efficacy and safety of
      SVT-15652 otic solution to that of Placebo, when administering one vial twice daily during 14
      days.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  At least 18 years of age

          -  Clinical diagnosis of otomycosis in one or both ears, where topical treatment is
             indicated.

          -  Signs/symptoms of pruritus, otalgia and ear fullness.

          -  Debris or drainage clinically consistent with fungal infection.

        Main Exclusion Criteria:

          -  Known bacterial otitis externa or malignant otitis externa.

          -  Tympanic perforation, tympanostomy tubes inserted and post mastoid surgery.

          -  Structural ear anomalies which may difficult the evaluation of the therapeutic
             response.

          -  Uncontrolled diabetes mellitus.

          -  Any infection requiring systemic antimicrobial or systemic antifungal therapy.

          -  Concomitant medicines that may interfere with the study evaluations.
A Follow-up Study Investigating Long Term Treatment With Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
Condition: Lung Diseases, Interstitial
MeSH terms: Lung Diseases; Lung Diseases, Interstitial
Intervention: Nintedanib
Intervention description: Bid
Intervention MeSH terms: Nintedanib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 435.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main objective is to assess long term tolerability and safety of treatment with oral
      nintedanib in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) who have
      complete (and did not prematurely discontinue trial medication in) the phase III parent
      trial, INBUILD® (trial 1199.247).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients who completed the INBUILD® trial as planned and who did not
             prematurely discontinue blinded treatment.

          -  Signed and dated written informed consent in accordance with ICH-GCP and local
             legislation prior to admission to the trial.

          -  Women of childbearing potential (WOCBP)1 must continue to use highly effective methods
             of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per
             year when used consistently and correctly, as well as one barrier method, for 28 days
             prior to and 3 months after nintedanib administration. A list of contraception methods
             meeting these criteria is provided in the patient information

        Exclusion Criteria:

          -  Any disease that may put the patient at risk when participating in this trial.
             Reconsider carefully all exclusion criteria of the INBUILD® trial. However, patients
             may qualify for participation even though exclusion criteria may have been met during
             the course of participation in INBUILD®, if the investigator's benefit-risk assessment
             remains favourable.

          -  Patients who must or wish to continue the intake of restricted medications or any drug
             considered likely to interfere with the safe conduct of the trial

          -  Patient not compliant in parent trial (INBUILD®), with trial medication or trial
             visits, according to investigator's judgement.

          -  Previous enrolment in this trial. Further exclusion criteria apply.
An Open-label Extension Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6)
Condition: Tuberous Sclerosis Complex; Seizures
MeSH terms: Tuberous Sclerosis; Seizures; Sclerosis
Intervention: GWP42003-P
Intervention description: Yellow oily solution containing cannabidiol dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.
Intervention MeSH terms: Cannabidiol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 199.0
Sex: All
Minimum age: 1 Year
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The
      open-label extension phase only will be described in this record. All participants will
      receive the same dose of GWP42003-P. However, investigators may subsequently decrease or
      increase the participant's dose until the optimal dose is found.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Completion of the GWEP1521 Blinded Phase
A Patient Handling Study of Mometasone Furoate/Formortoral Fumarate (MF/F) Metered Dose Inhaler (MDI) With an Integrated Dose Counter in Adolescent and Adult Subjects With Asthma or Chronic Obstructive Pulmonary Disease (Study P04703AM1)
Condition: Asthma; COPD
MeSH terms: Asthma
Intervention: SCH No. 418131 (Mometasone Furoate/Formoterol Furoate abbreviated MF/F )
Intervention description: MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of MF/F MDI 50/5 mcg, twice a day) over a 4-week Treatment Period.
Intervention MeSH terms: Mometasone Furoate; Formoterol Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 272.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This was an open-label, multiple-dose, study of mometasone furoate/formoterol fumarate (MF/F)
      metered dose inhaler (MDI) 100/10 micrograms (mcg) twice daily (BID) (2 puffs of MF/F MDI
      50/5 mcg, administered twice a day approximately 12 hours apart) in participants 12 years of
      age or older, with a diagnosis of persistent asthma or chronic obstructive pulmonary disease
      (COPD) of at least 12 months. The primary purpose of the study was to evaluate the
      performance of the MF/F MDI integrated dose counter under normal patient handling conditions.
    

Eligibility criteria:

        Diagnosis and Criteria for Inclusion:

          -  A participant must have been at least 12 years of age, of either sex, and of any race,
             with a diagnosis of persistent asthma or COPD of at least 12 months.

          -  A participant must have been able to demonstrate correct use of an MDI without a
             counter at the Screening Visit.

          -  A participant must have demonstrated at least 90% compliance with completion of the
             e-diary, use of the counterstrip, and use of the study medication over the 2-week
             Screening Period.

        Exclusion Criteria:

          -  Participants with a serious uncontrolled medical disorder, which in the judgment of
             the investigator, could have interfered with the study, or required treatment which
             might interfere with the study.

          -  Participants who in the judgment of the investigator and/or sponsor had a significant
             recent or current, repetitive strain injury (RSI) that may have impacted their ability
             to effectively participate in the full duration of the study.