bioihbjkbjnl/mcl2 huggingface dataset:
Long-Term Exposure to Rizatriptan 5-mg and 10-mg Oral Tablet (Combined Extension Protocols MK-0462-022, MK-0462-025, MK-0462-029)
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Intervention: Rizatriptan 5 mg; Rizatriptan 10 mg; Standard Care
Intervention description: Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s); Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s); Active standard care
Intervention MeSH terms: Rizatriptan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 1959.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Migraine headache

Summary:

      This record describes pooled data for three extension studies: MK-0462-022 (NCT00897949);
      MK-0462-025 (NCT00899379); and MK-0462-029 (NCT00897104). These studies examined the
      long-term safety and efficacy of rizatriptan used for the treatment of acute migraine and
      migraine recurrence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant took part in study MK-0462-022, MK-0462-025, or MK-0462-029

          -  History of migraine headache
Multi-national, Safety and Performance Study of New Ostomy Product Compared to Standard Care
Condition: Leakage; Skin Condition
MeSH terms: Skin Diseases
Intervention: New ostomy base plate (SS); Standard Care base plate
Intervention description: The base plate is applied to the skin around the stoma and an ostomy bag is clicked onto the base plate.; The base plate is applied to the skin around the stoma and an ostomy bag is clicked onto the base plate.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary object of this study is to provide clinical documentation for the New base plate
      significantly 'reduces the degree of Leakage' under the base plate compared to Standard Care
      base plates.

      The secondary objectives are to provide clinical documentation on several performance and
      safety parameters on the New base plate compared to Standard Care base plates.

      The primary hypothesis is that the New base plate significantly reduces degree of leakage
      under the base plate compared to Standard Care base plates.

      Each test period will last for two weeks. In addition to this there will be one week run-in
      period on New base plate. The data will be collected by investigator in the Case Report Form
      at the inclusion visit, cross-over visit and termination visit. Data will also be collected
      by the subject in a questionnaire during the two test periods.

      The subjects will change their base plates on per need basis and continue with their normal
      changing pattern in the entire study period.

      100 subjects with ileostomy will be included in the study. The subjects will be recruited
      from Europe including Denmark, Norway, Sweden, Iceland, Germany and France.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Have given written Informed Consent

          2. Is at least 18 years old

          3. Has the mental capacity to understand the study guidelines and questionnaires

          4. Has had their ileostomy for at least 3 months

          5. Has an ileostomy with a diameter between 19-40 mm

          6. Is currently using a flat 2-piece product with with mechanical coupling

          7. Is able to change the base plate by themselves or with help from a caregiver (e.g.
             spouse)

          8. Has experienced leakage under the base plate at least once a week over the last 2
             weeks

        Exclusion Criteria:

          1. Is pregnant or breast-feeding

          2. Currently receiving or has within the past 2 months received radio- and/or
             chemotherapy

          3. Currently using topical steroid product on peristomal skin (injections and oral
             treatment are accepted)

          4. Is currently using a convex base plate

          5. Participating in other clinical studies or has previously participated in this study
A Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Diabetic Neuropathy
Condition: Painful Diabetic Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies; Pain
Intervention: Lacosamide
Intervention description: Lacosamide film-coated tablets; two times per day; up to 400 mg/day for 2.75 years
Intervention MeSH terms: Lacosamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 371.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Painful diabetic neuropathy; Lacosamide

Summary:

      The purpose of this study is to determine if lacosamide (SPM 927) is safe if taken for a
      longer period of time and whether it continues to work well to treat pain.

      Subjects will receive lacosamide at a dose that will be individually determined to be the one
      that provides most pain relief with the least side effects. The maximum dose will be
      600mg/day. Subjects may participate in this trial until October 2007. This time may be
      extended to allow them to participate until lacosamide is commercially available.

      If a subject meet the requirements for the study at Visit 1 and after a two weeks phase
      without trial medication, s/he enters a Titration Phase to determine the personal optimal
      dose of lacosamide. When this dose is reached s/he will enter the Maintenance Phase and will
      be asked to return for visits every 4 weeks for the first 24 weeks and every 12 weeks
      thereafter.
    

Eligibility criteria:

        Inclusion Criteria:

        Inclusion Criteria:

          -  Painful diabetic neuropathy

        Exclusion Criteria:

          -  no clinically relevant liver enzyme abnormalities and impaired renal function, no
             cardiac abnormalities, no pregnant or nursing females

        Exclusion Criteria:
Vortioxetine to Prevent Return of Symptoms in Children With Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Intervention: Vortioxetine; Placebo
Intervention description: Tablets; Tablets
Intervention MeSH terms: Vortioxetine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 35.0
Sex: All
Minimum age: 7 Years
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to find out if vortioxetine is better than placebo (sugar pills)
      in preventing depression in children who improved when treated with vortioxetine.
    

Eligibility criteria:

        Inclusion Criteria:

        De novo participants

          -  The participant has a primary diagnosis of MDD according to DSM-5™ although co-morbid
             anxiety disorders will be permitted (except Post Traumatic Stress Disorder (PTSD) and
             Obsessive Compulsive Disorder (OCD)).

          -  The participant has a CDRS-R total score ≥45 at the Screening and Baseline Visits.

          -  The participant has a Clinical Global Impression - Severity of Illness (CGI-S) ≥4 at
             the Screening and Baseline Visit

        Exclusion Criteria:

          -  The participant receives ongoing current psychotherapy that is planned to be
             intensified. Interpersonal psychotherapy (IPT) or cognitive behavioural therapy (CBT)
             are not allowed.

          -  The participant presents with, or has a history of, an Axis I (DSM-5TM) diagnosis of
             Bipolar Disorder, PTSD, OCD, Autism, Pervasive Developmental Disorder (PDD), or
             Schizophrenia or Schizoaffective Disorder.

          -  The participant has a diagnosis of attention-deficit/hyperactivity disorder (ADHD) and
             is not maintained on a stable dose of a methylphenidate or amphetamine for a minimum
             of 4 weeks prior to the study treatment.

          -  The participant has attempted suicide or is at significant risk of suicide

        Other inclusion and exclusion criteria may apply.
Evaluate Safety and Efficacy of ABT-335 in Combination With Atorvastatin in Subjects With Multiple Abnormal Lipid Levels in the Blood
Condition: Mixed Dyslipidemia; Coronary Heart Disease; Dyslipidemia
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Dyslipidemias
Intervention: ABT-335; Atorvastatin; Placebo
Intervention description: 135 mg, daily, 12 weeks; Daily, 12 weeks, see Arm Description for dosage information; daily, 12 weeks, see Arm Description for placebo information
Intervention MeSH terms: Atorvastatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 613.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Mixed Dyslipidemia; Coronary Heart Disease; Dyslipidemia

Summary:

      The purpose of this study is to compare the safety and efficacy of fenofibric acid (ABT-335)
      + atorvastatin combination therapy with ABT-335 and atorvastatin monotherapy in subjects with
      multiple abnormal lipid levels in the blood.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with mixed dyslipidemia

          -  Subjects must agree to utilize adequate birth control methods and to adhere to the
             American Heart Association (AHA) diet

        Exclusion Criteria:

          -  Subjects with unstable medical conditions or medical conditions considered
             inappropriate in a clinical trial.

          -  Patients who are taking certain medications or unstable dose of specific medications.

          -  Women who are pregnant or plan on becoming pregnant, or women who are lactating.
Efficacy and Safety Study of OPC-1085EL Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension
Condition: Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Hypertension
Intervention: OPC-1085EL ophthalmic solution; Latanoprost ophthalmic solution
Intervention MeSH terms: Carteolol; Pharmaceutical Solutions; Latanoprost; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 237.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the efficacy and safety of OPC-1085EL ophthalmic
      solution in comparison with latanoprost ophthalmic solution in subjects who are
      insufficiently responsive to latanoprost ophthalmic solution.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with diagnosis of bilateral primary open-angle glaucoma or ocular
             hypertension

        Exclusion Criteria:

          -  Subjects with ocular conditions as defined by the protocol
Clinical Safety Study of the Progesterone Vaginal Ring in Women Undergoing Assisted Reproductive Technology Procedures
Condition: Progesterone Supplementation in Women Undergoing ART
Intervention: Progesterone vaginal ring
Intervention description: A flexible, non-degradable PVR containing progesterone in micronized formulation and dispersed evenly throughout the ring.
Intervention MeSH terms: Progesterone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: Open-label trial
Enrollment: 352.0
Sex: Female
Minimum age: 18 Years
Maximum age: 34 Years
Healthy volunteers: No
Keywords: Progesterone vaginal ring (PVR); Vaginal progesterone ring; Assisted reproductive technology (ART); Infertility

Summary:

      The purpose of the study is to assess the safety of Progesterone Vaginal Ring (PVR) in women
      undergoing fresh embryo transfer (ART).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pre-menopausal women aged 18-34 at the time of consent.

          -  Documentation of a normal uterine cavity by hysteroscopy, hydrosonogram, or
             hysterosalpingogram within one year of screening.

          -  Normal Pap smear test within 24 months of screening.

          -  At least one cycle without reproductive hormone medication prior to screening
             follicle-stimulating hormone (FSH) and estradiol blood draw.

          -  Tubal, idiopathic, male factor, ovulatory dysfunction, or endometriosis-linked
             infertility.

        Exclusion Criteria:

          -  Body mass index greater than 38 kg/m^2.

          -  FSH greater than 15 IU/L during the early follicular phase (Day 2-4). For those
             participants with polycystic ovarian syndrome, a Day 2-4 FSH level can be obtained
             following a progestogen withdrawal or spontaneous menses.

          -  Clinically significant gynecologic pathology, such as submucosal fibroids, intramural
             fibroids >5 cm, communicating hydrosalpinx, uncorrected uterine septum, endometrial
             cancer or endometrial atypia, scar tissue inside the cavity or poorly developed
             uterine lining from prior uterine surgery, pelvic tuberculosis, or any other
             conditions that could adversely affect pregnancy success.

          -  Uncontrolled elevation of prolactin or too little thyroid hormone in the blood.

          -  History of more than one failed fresh in vitro fertilization cycle. A failed cycle is
             defined as having started a cycle and not becoming pregnant or pregnancy loss prior to
             the 20th week of pregnancy.
Effects of Triptorelin Pamoate in Children With Precocious Puberty - Follow up Study
Condition: Precocious Puberty
MeSH terms: Puberty, Precocious
Intervention: Triptorelin (I.N.N.)
Intervention description: Decapeptyl® SR 11.25mg
Intervention MeSH terms: Triptorelin Pamoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Healthy volunteers: No

Summary:

      The purpose of the protocol is to assess the efficacy of triptorelin 11.25 mg with respect to
      the proportion of children who maintain a regression or stabilisation of sexual maturity
      until the end of the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The child must have completed study 2-54-52014-143

          -  The child must have an effective response to 2 injections of triptorelin 11.25 mg
             according to investigator's evaluation with no significant treatment side effects

        Exclusion Criteria:

          -  The patient has a known hypersensitivity to any of the test materials or related
             compounds

          -  The patient is unable or unwilling to comply fully with the protocol
A Study Assessing the Efficacy and Safety of Sarilumab Added to MTX in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis (SARIL-RA-KAKEHASI)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Sarilumab SAR153191 (REGN88); Placebo (for sarilumab); Methotrexate; Folic acid
Intervention description: Pharmaceutical form: solution for injection Route of administration: subcutaneous; Pharmaceutical form: solution for injection Route of administration: subcutaneous; Dispensed according to local practice.; Dispensed according to local practice.
Intervention MeSH terms: Folic Acid; Methotrexate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 243.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      -To demonstrate that sarilumab added to methotrexate (MTX) reduce signs and symptoms of
      rheumatoid arthritis (RA) in Japanese RA participants with an inadequate response to MTX.

      Secondary Objective:

      -To assess the safety of sarilumab added to MTX in Japanese RA participants with an
      inadequate response to MTX.
    

Eligibility criteria:

        Inclusion criteria:

          -  Diagnosis of RA, according to the American College of Rheumatology/The European League
             Against Rheumatism (ACR/EULAR) 2010 Rheumatoid Arthritis Classification Criteria with
             >=3 months disease duration.

          -  Moderately to severely active RA defined as:

          -  At least 8 of 68 tender joints and 6 of 66 swollen joints at screening visit.

          -  High sensitivity C-Reactive Protein (hs-CRP) >=6mg/L at screening visit.

        Exclusion criteria:

          -  Participants <20 or >75 years of age.

          -  Treatment with any Disease-modifying antirheumatic drug (DMARD) other than MTX or
             biologic agent without the appropriate off-drug period prior to screening.

          -  Prior treatment with anti-interleukin-6 (anti-IL-6) or anti-interleukin-6 receptor
             (IL-6R) antagonist therapies, including but not limited to tocilizumab or sarilumab.

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.
Effect of Fluoride in a Dentifrice on Remineralization of Erosive Lesions
Condition: Enamel Erosion
Intervention: sodium fluoride; no added fluoride in a silica base
Intervention description: fluoride as sodium fluoride; no added fluoride
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The proposed study will evaluate the performance of fluoride delivered from a new dentifrice
      formulation without potassium nitrate. It will also evaluate the dose-response to fluoride by
      testing four dentifrices covering a range of sodium fluoride concentration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  intact maxillary dental arch suitable to retain a palatal appliance, an intact
             mandibular dental arch and a stimulated/unstimulated saliva flow rate of ≥ 0.8
             milliliter/minute (ml/min) and ≥ 0.2 ml/min respectively.
Swiss studY for the Treatment of COPD Patients With the Free combiNation of indacatERol and GlYcopyrroniumbromide.
Condition: Chronic Obstructive Pulmonary Disease: COPD
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: QAB149; Placebo; NVA237
Intervention description: Capsule form in blister packs inhaled with the Novartis Concept 1 SDDPI; Capsule form in blister packs inhaled with the Novartis Concept 1 SDDPI; Capsule form in blister packs inhaled with the Novartis Concept 1 SDDPI
Intervention MeSH terms: Glycopyrrolate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 79.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Moderate to severe COPD patients are included; NVA; QAB

Summary:

      The study purpose is to evaluate the effect of QAB149

        -  NVA237 vs. QAB149 on static lung hyperinflation.
    

Eligibility criteria:

        Inclusion criteria:

          -  Male and female patients, ≥40 years of age, with a documented diagnosis of moderate or
             severe COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD)
             criteria and >10-pack year history of smoking

          -  FEV1 <80% and ≥30% of the predicted normal value who have signed an informed consent
             form prior to the initiation of any study-related procedure

        Exclusion criteria:

          -  No COPD exacerbations within 6 weeks prior to dosing

          -  No concomitant lung disease such as asthma

          -  Nno requirement for long term oxygen treatment or history of lung reduction surgery

          -  No medical conditions that would interfere with the performance of spirometry

          -  No other medical condition that in the opinion of the investigator may cause the
             patient to be unsuitable for completion of the study or place the patient at potential
             risk form being in the study e.g. uncontrolled hypertension or unstable ischemic heart
             disease.
Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis
Condition: Relapsing-remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Fingolimod 1.25 mg; Fingolimod 0.5 mg; Placebo
Intervention description: Patients self-administered fingolimod 1.25 mg capsules orally once daily.; Patients self-administered fingolimod 0.5 mg capsules orally once daily.; Patients self-administered a fingolimod placebo capsule 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, Investigator, Outcomes Assessor)
Enrollment: 1272.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Multiple Sclerosis; FTY720; Fingolimod

Summary:

      This study assessed the efficacy, safety, and tolerability of 2 doses of oral fingolimod
      (1.25 mg/day and 0.5 mg/day) compared to placebo in patients with relapsing-remitting
      multiple sclerosis (RRMS)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients between ages 18-55 with a diagnosis of multiple sclerosis

          -  Patients with a relapsing-remitting disease course

          -  Patients with EDSS score of 0-5.5

        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 applied to this study.