bioihbjkbjnl/mcl2 huggingface dataset:
Long-term Study of DSP-5423P in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: DSP-5423P
Intervention description: 40-80mg/day
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study evaluates the long term safety of DSP-5423P in patients with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have schizophrenia diagnosed by DSM-5, diagnostic criteria

          -  Patients who are aged 18 years or older at informed consent

          -  Patient understands the objectives and procedures of the study and who provide written
             voluntarily consent to participate in the study, etc.

        Exclusion Criteria:

          -  Patients who fall under a contraindication listed in the LONASEN® package insert

          -  Patients with Parkinson disease, etc.
Double-Blind Follow-on Safety Study of HZT-501 (Ibuprofen 800 mg/Famotidine 26.6 mg) in Subjects Who Have Completed Participation in HZ-CA-301 (NCT00450658) or HZ-CA-303 (NCT00450216)
Condition: Osteoarthritis; Rheumatoid Arthritis; Chronic Low Back Pain; Chronic Regional Pain Syndrome; Chronic Soft Tissue Pain
MeSH terms: Low Back Pain; Nociceptive Pain
Intervention: HZT-501; Ibuprofen
Intervention description: Ibuprofen 800mg/famotidine 26.6 mg administered orally 3 times daily for 2 weeks; Ibuprofen 800mg administered orally 3 times daily for at least 28 weeks
Intervention MeSH terms: Ibuprofen
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 179.0
Sex: All
Minimum age: 40 Years
Maximum age: 81 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety of long-term treatment with HZT-501.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Expected to continue to require daily administration of an NSAID for at least the
             coming 6 months.

          -  Subject completed the 24-week Treatment period of either Horizon Protocol HZ-CA-301 or
             HZ-CA-303

        Exclusion Criteria:

          -  Subject didn't meet all of the Inclusion and Exclusion Criteria for Horizon Protocol
             HZ-CA-301 or HZ-CA-303

          -  Subject developed or experienced any of the following while on either HZ-CA-301 or
             HZ-CA-303

          -  Malignant Disease of the gastrointestinal tract

          -  Erosive esophagitis

          -  Clinically significant cardiac, renal or hepatic disease

          -  Uncontrolled diabetes

          -  Positive pregnancy test on Study Day 0

          -  Please note that there are other additional criteria. The study center will determine
             if you meet all of the criteria.
Double-blind Trial to Investigate Efficacy and Tolerance of Ambroxol Lozenges 20 mg in Sore Throat
Condition: Pharyngitis
MeSH terms: Pharyngitis
Intervention: Ambroxol; Placebo
Intervention MeSH terms: Ambroxol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 249.0
Sex: All
Minimum age: 16 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The aim of this trial is to investigate the efficacy and tolerance of Ambroxol lozenges 20 mg
      in the treatment of sore throat in patients with acute viral pharyngitis.
    

Eligibility criteria:

        1. Patients having a sore throat with acute viral pharyngitis. 2. Female and male ambulant
        patients between the ages of 18 and 65. 3. The throat pain intensity is rated at least
        severe on the VRS (PI). 4. Written Informed Consent is given by the patient. 5. Compliance
        by the patient seems guaranteed.

          1. Patients with symptoms of primarily bacterial pharyngitis or bacterial secondary
             infection (clinical findings; inter alia assessment of exudate).

          2. First indication of symptoms of acute pharyngitis (e.g., sore throat) occurred more
             than 3 days ago already.

          3. Counting of white blood cell in blood routine examination exceeds 10?109/L.

          4. Patients who suffered from acute viral or bacterial pharyngitis in the past 4 weeks.

          5. Broncho-motor disorders or concomitant diseases with relatively large quantities of
             secretion (danger of secretion blockage).

          6. Known hypersensitivity to Ambroxol or to auxiliary substances contained in the tablet.

          7. Previous and/or existing tumour condition.

          8. Pregnancy and/or breast-feeding.

          9. Alcohol, and/or drug abuse.

         10. Simultaneous participation in another clinical trial.
Tanezumab in Osteoarthritis of the Knee
Condition: Arthritis; Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: tanezumab; tanezumab; tanezumab; Placebo
Intervention description: IV tanezumab 10 mg at 1 dose every 8 weeks; IV tanezumab 5 mg at 1 dose every 8 weeks; IV tanezumab 2.5 mg at 1 dose every 8 weeks; IV placebo to match tanezumab at 1 dose every 8 weeks
Intervention MeSH terms: Tanezumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 697.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: monoclonal antibody; RN624; PF-04383119; nerve growth factor; anti-nerve growth factor; OA; pain

Summary:

      Test the efficacy and safety of 3 doses in Osteoarthritis of the knee in patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Osteoarthritis of the knee according to ACR criteria with a Kellgren-Lawrence x-ray
             grade of 2.

          -  Unwilling or unable to take non-opiate pain medications, for whom non-opiate pain
             medications have not provided adequate pain relief or are candidates for knee
             injections arthroplasty or replace surgery.

          -  Pain level and function levels as required by the protocol at Screening and Baseline.

          -  Willing to discontinue pain medications (acetaminophen will be permitted up to a
             certain level) before and during the study.

          -  Must agree to the contraceptive requirements of the protocol if applicable.

          -  Must agree to the treatment plan, scheduled visits, and procedures of the protocol.

        Exclusion Criteria:

          -  Pregnancy or intent to become pregnant during the study

          -  BMI greater than 39

          -  other severe pain, significant cardiac, neurological or psychological conditions, or
             above the protocol limits for laboratory and blood pressure results
Long-Term Safety and Efficacy of rFVIIIFc in the Prevention and Treatment of Bleeding Episodes in Previously Treated Participants With Hemophilia A
Condition: Hemophilia A
MeSH terms: Hemophilia A
Intervention: rFVIIIFc
Intervention description: Administered as specified in the treatment arm.
Intervention MeSH terms: Factor VIII
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 240.0
Sex: Male
Minimum age: 0 Years
Healthy volunteers: No
Keywords: rFVIIIFc; A-LONG Extension

Summary:

      The primary objective of the study is to evaluate the long-term safety of recombinant human
      Factor VIII Fc fusion protein (rFVIIIFc) in participants with hemophilia A. The secondary
      objective of the study is to evaluate the efficacy of rFVIIIFc in the prevention and
      treatment of bleeding episodes in participants with hemophilia A.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Subjects who have completed previous rFVIIIFc studies (NCT01181128, NCT02083965,
             NCT01458106 and NCT02502149)

          -  Ability to understand purposes and risks of the study and to provide signed and dated
             informed consent (or assent, as applicable).

        Key Exclusion Criteria:

          -  Confirmed positive high-titer inhibitor (≥5.00 BU/mL).

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Study of Efficacy & Safety for 3 Infusion Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia
Condition: Hyponatremia
MeSH terms: Hyponatremia
Intervention: Conivaptan; Placebo
Intervention description: premix bag; premix bag
Intervention MeSH terms: Conivaptan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hyponatremia; hypervolemic; euvolemic; edematous; conivaptan

Summary:

      The study is designed to assess the efficacy and safety of multiple infusions of conivaptan
      in subjects with euvolemic or hypervolemic hyponatremia
    

Eligibility criteria:

        Inclusion Criteria:

          -  Euvolemic or hypervolemic (edematous) based on clinical presentation

          -  Serum sodium between 115 and 130mEq/L at baseline

        Exclusion Criteria:

          -  Clinical presentation of volume depletion or dehydration
Effects on Ovarian Function of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing DRSP/EE (292003)(COMPLETED)(P05723)
Condition: Contraception
Intervention: NOMAC-E2; DRSP-EE
Intervention description: Nomegestrol Acetate and Estradiol Tablets, 2.5 mg NOMAC and 1.5 mg E2 taken once daily from Day 1 of menstrual period up to and including Day 28
for 6 consecutive 28-day menstrual cycles.; Drospirenone and Ethinyl Estradiol Tablets, 3 mg DRSP and 30 mcg EE taken once daily from Day 1 of menstrual period up to and including Day 28 for 6 consecutive 28-day menstrual cycles.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: Female
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary purpose of this study is to evaluate the effects of the nomegestrol
      acetate-estradiol (NOMAC-E2) combined oral contraceptive (COC) on ovarian function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing to use COC for at least 6 cycles.

          -  18 - 35 years of age at screening.

          -  Body Mass Index (BMI) of >/= 17 and </= 35.

          -  Good physical and mental health.

          -  Willing to use condoms as the sole contraceptive method during screening cycle and 1
             post-treatment cycle.

          -  Willing to give informed consent.

        Exclusion Criteria:

          -  Contraindications for contraceptive steroids (general).

          -  Additional contraindications (renal, hepatic or adrenal insufficiency).

          -  Breastfeeding.

          -  Present use (or use within 2 months prior to start of the trial medication) of the
             following drugs: phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine,
             topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, ketoconazole,
             sex

        steroids (other than pre- and post treatment contraceptive method) and herbal remedies
        containing Hypericum perforatum (St. John's Wort).

          -  Administration of any other investigational drugs and/or participation in another
             clinical trial within 2 months prior to the start of the trial medication or during
             the trial period.

          -  Abnormal cervical smear at screening, or documentation of an abnormal smear performed
             within 6 months before screening.

          -  Clinically relevant abnormal laboratory result at screening as judged by the
             investigator.
Loteprednol Etabonate in an Ophthalmic Base vs Vehicle for the Treatment of Inflammation Following Cataract Surgery
Condition: Ocular Inflammation
MeSH terms: Cataract; Inflammation
Intervention: Loteprednol Etabonate; Vehicle of Ophthalmic Loteprednol Etabonate
Intervention description: Loteprednol Etabonate in an ophthalmic base will be administered to study eye 4 times a day(QID) for 14 days.; Vehicle of ophthalmic loteprednol etabonate administered postoperatively to study eye 4 times a day(QID) for 14 days.
Intervention MeSH terms: Loteprednol Etabonate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 400.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Evaluation of the clinical safety and efficacy of loteprednol etabonate in an ophthalmic
      base, when compared to vehicle for the treatment of inflammation following cataract surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects at least 18 years of age

          -  Subjects who have the ability to understand and sign an informed consent form and
             provide Health Insurance Portability and Accountability Act (HIPAA) authorization.

          -  Subjects who are candidate for routine, uncomplicated cataract surgery.

          -  Subjects who are not of childbearing potential or subjects who have a negative urine
             pregnancy test result at screening.

          -  Subjects must be willing and able to comply with all treatment and follow- up
             procedures.

        Exclusion Criteria:

          -  Subjects who have known hypersensitivity or contraindication to the study drug or its
             components.

          -  Subjects who have a history or presence of chronic generalized systemic disease that
             the investigator feels might increase the risk to the subject or compound the result
             of the study.

          -  Subjects who have a severe/serious ocular condition, or any other unstable medical
             condition that, in the Investigator's opinion, may preclude study treatment or
             follow-up.

          -  Subjects with elevated intraocular pressure (>/= 21 mm Hg), uncontrolled glaucoma, or
             being treated for glaucoma in the study eye.

          -  Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the
             non-study eye.

          -  Subjects who have had ocular surgery in the study eye within 3 months or in the fellow
             eye within 2 weeks prior to the screening visit.

          -  Women who are pregnant or breast feeding.

          -  Subjects who have participated in an investigational drug or device study within the
             last 30 days.

          -  Subjects previously randomized in this study.
A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)
Condition: Primary Immune Thrombocytopenia
MeSH terms: Thrombocytopenia; Purpura, Thrombocytopenic, Idiopathic
Intervention: Rozanolixizumab
Intervention description: Study participants receive rozanolixizumab by subcutaneous infusion during the Treatment Period.
Intervention MeSH terms: Rozanolixizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ITP; UCB7665; Rozanolixizumab; Primary immune thrombocytopenia

Summary:

      The purpose of this study is to assess the long-term safety, tolerability and clinical
      efficacy of treatment with rozanolixizumab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Study participant completed TP0003 [NCT04200456] or TP0006 [NCT04224688] until Visit
             27 (Week 25) and, in the opinion of the investigator, has been compliant with the
             TP0003 or TP0006 study assessments

          -  The study participant is considered reliable and capable of adhering to the protocol,
             visit schedule, or medication intake according to the judgment of the investigator

          -  Study participants may be male or female:

               1. A male participant must agree to use contraception during the Treatment Period
                  and for at least 3 months after the final dose of study treatment and refrain
                  from donating sperm during this period

               2. A female participant is eligible to participate if she is not pregnant as
                  confirmed by a negative urine pregnancy test and not planning to get pregnant
                  during the participation in the study, not breastfeeding, and at least one of the
                  following conditions applies:

        Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the
        contraceptive guidance during the Treatment Period and for at least 3 months after the
        final dose of study treatment

        Exclusion Criteria:

          -  Study participant has any ongoing investigational medicinal product (IMP)-related
             serious adverse event (SAE) or ongoing severe IMP-related treatment-emergent adverse
             event (TEAE) experienced during TP0003 or TP0006

          -  Study participant has, at last available assessment of TP0003 or TP0006, 3.0x upper
             limit of normal (ULN) of any of the following: alanine aminotransferase (ALT),
             aspartate aminotransferase (AST), or alkaline phosphatase (ALP)
Rituximab to Prevent Recurrence of Proteinuria
Condition: FSGS; Proteinuria
MeSH terms: Proteinuria; Recurrence
Intervention: Rituximab
Intervention description: Induction therapy
Intervention MeSH terms: Rituximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 7 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The investigators propose to study novel targets of rituximab in podocytes, with a particular
      focus on recurrent focal segmental glomerulosclerosis (FSGS). The proposed study has strong
      clinical implications, since it may extend the approved indications for rituximab treatment
      to recurrent FSGS as well as to other proteinuric diseases. Furthermore, it will offer new
      insights into the role of sphyngomyelin related enzymes in podocyte function in health and
      disease, thus allowing the identification of novel targets for antiproteinuric drug
      development. Finally, the proposed study offers the opportunity to identify a correlation
      between the patient's specific clinical outcome and the experimental results obtained after
      exposing podocytes to patient sera in the presence or absence of rituximab. Therefore, it may
      lead to the development of an assay for the pre-transplant identification of patients at
      high-risk for recurrent disease and, among them, may allow the identification of those
      patients that will respond to rituximab.
    

Eligibility criteria:

        Inclusion:

          1. Patient has been fully informed and has signed a dated IRB-approval informed consent
             form.

          2. Age 7-65 years.

          3. Male and Females diagnosed of FSGS by kidney biopsy. Kidney biopsy report is not
             required once the physician confirms the diagnosis. Transcribed reports from referring
             physicians are also valid.

        Exclusion:

          1. Recipient or donor is seropositive for human immunodeficiency virus (HIV), Hepatitis C
             viruses, or Hepatitis B virus antigenemia.

          2. Patient has a current malignancy or a history of malignancy (within the past 5 years),
             except non-metastatic basal or squamous cell carcinoma of the skin that has been
             treated successfully or carcinoma in situ of the cervix that has been treated
             successfully.

          3. Patient has uncontrolled concomitant infections and/or severe diarrhea, vomiting,
             active upper gastro-intestinal tract malabsorption or an active peptic ulcer or any
             other unstable medical condition that could interfere with study objectives.

          4. Patient is pregnant or lactating.

          5. Patient has any form of substance abuse, psychiatric disorder or a condition that, in
             opinion of the investigator, may invalidate communication with the investigator.

          6. Patients with a defined genetic cause of FSGS.
Dysport® Adult Lower Limb Spasticity Study
Condition: Leg Spasticity
MeSH terms: Muscle Spasticity
Intervention: Botulinum toxin type A; Placebo
Intervention description: I.M. injection on day 1 (single treatment cycle); I.M. injection on day 1 (single treatment cycle)
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 388.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to assess the efficacy of Dysport® compared to placebo
      in improving muscle tone in hemiparetic subjects with lower limb spasticity due to stroke or
      traumatic brain injury.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects aged 18 to 80 years of age

          -  Post stroke or brain injury

          -  Intensity of muscle tone greater than or equal to 2, as measured on the Modified
             Ashworth Scale

          -  Ambulatory patients

        Exclusion Criteria:

          -  Fixed contractures

          -  Physiotherapy initiated less than 4 weeks before entry

          -  Previous surgery or previous treatment with phenol and/or alcohol in lower limb

          -  Neurological/neuromuscular disorders which may interfere with protocol evaluations