bioihbjkbjnl/mcl2 huggingface dataset:
Long-Term Safety and Efficacy Study of Avanafil in Men With Erectile Dysfunction
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Intervention: avanafil
Intervention description: All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with 100 mg may undergo dose reduction to 50 mg. Subjects who tolerate avanafil 100 mg but who desire increased efficacy may request a dose increase to 200 mg.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 712.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ED; Erectile Dysfunction; Dysfunction; Erectile

Summary:

      This open-label study is being conducted to evaluate the long-term safety, tolerability, and
      efficacy of avanafil in men with mild to severe erectile dysfunction. Approximately 400
      subjects will be enrolled and treated with avanafil for up to 52 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Successfully completed the entire treatment period in a qualifying study (TA-301
             [NCT00790751] or TA-302 [NCT00809471]);

          -  Demonstrated compliance with the study protocol, including drug administration, diary
             completion, and scheduled study visits, during the qualifying trial;

          -  Made at least 4 attempts at intercourse during the last treatment period of the
             qualifying trial;

          -  Agree to make at least 4 attempts at intercourse each month through the course of this
             study;

          -  Agree not to use any other treatments for erectile dysfunction during participation in
             this study.

          -  Provide written informed consent;

          -  Willing and able to comply with scheduled study visits, treatment plan, laboratory
             tests, and other study procedures.

        Exclusion Criteria:

          -  Subjects who, in the opinion of the investigator, have developed one or more
             comorbidities during the qualifying study that would pose a safety concern to their
             continuation on treatment in study TA-314;

          -  Subjects requiring treatment with an excluded medication.
Clinical Trials of Adjuvant Androgen Deprivation in Localized Prostate Cancer
Condition: Prostate Adenocarcinoma
MeSH terms: Adenocarcinoma
Intervention: Short term androgen deprivation; Long term androgen deprivation; Short term androgen deprivation; Long term androgen deprivation
Intervention description: Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
Bicalutamide 50 mg tablet every day for 2 months; Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
Bicalutamide 50 mg tablet every day for 2 months
Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy; Minimum dose of 76 Gy (range 76-82 Gy); Minimum dose of 76 Gy (range 76-82 Gy)
Intervention MeSH terms: Ascorbic Acid; Methyltestosterone; Androgens; Estrogens, Conjugated (USP)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 362.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Patients with prostate adenocarcinoma

Summary:

      The present study is a phase III randomized and multicentric trial evaluating the potential
      additional impact effect of two years adjuvant androgen deprivation when combined with
      neoadjuvant (4 months) and high-dose (76 Gy) conformal radiotherapy in moderate high-risk
      prostate cancer patients. Stratification will be performed by prognostic factors and by
      participating institution.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological proven adenocarcinoma of the prostate

          -  Stage: cT1c-3b N0M0 according to American Joint Committee on Cancer (AJCC) Tumor Node
             Metastasis (TNM)

          -  Prostatic Specific Antigen (PSA)<100 ng/ml

          -  Intermediate (T1-T2 with Gleason Score [GS] 7 and/or PSA 10-20)

          -  High risk (T3 and/or GS 8-10 and/or PSA > 20)

          -  Karnofsky Index (KI) performance status ≥70%

          -  Written informed consent

        Exclusion Criteria:

          -  T4 N1 M1,

          -  Previous surgical treatment (prostatectomy or cryosurgery)

          -  Neoadjuvant hormonal treatment > 3 months.

          -  History of pelvic radiotherapy (RT)

          -  Contraindications for radiotherapy

          -  Concomitant use of chemotherapy

          -  Serious psychiatric or medical condition

          -  Current synchronic malignancies
Lubiprostone for Children With Constipation
Condition: Constipation - Functional
MeSH terms: Constipation
Intervention: Lubiprostone
Intervention description: 12 or 24 mcg soft capsules for oral administration
Intervention MeSH terms: Lubiprostone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 419.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This study is for children with constipation.

      Children who completed 3 months of treatment in the earlier study (NCT02042183):

        -  were invited to participate

        -  will receive lubiprostone for 9 more months

        -  will see if lubiprostone safely relieves their constipation if taken for a whole year
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has completed the 3-month placebo-controlled study (NCT02042183)

          -  Will continue to abstain from taking concomitant medication (prescribed or
             over-the-counter) that affects gastrointestinal motility

        Exclusion Criteria:

          -  Has untreated faecal impaction at the time of rolling over into study

          -  Has significant change in medical status, newly diagnosed and uncontrolled
             cardiovascular, liver or lung disease, neurologic or psychiatric disorder, or other
             systemic disease

          -  Has demonstrated non-compliance with study protocol during the 3-month
             placebo-controlled study (NCT02042183)
A Study of ALKS 3831 in Adults With Schizophrenia (The ENLIGHTEN-2 Study)
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: ALKS 3831; Olanzapine
Intervention description: Daily dosing; Daily dosing
Intervention MeSH terms: Olanzapine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 561.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Alkermes; ALKS 3831; Samidorphan; Schizophrenia; Olanzapine; Weight

Summary:

      This study will evaluate weight gain of ALKS 3831 compared to olanzapine in adult subjects
      with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has a body mass index (BMI) of 18.0-30.0 kg/m^2, inclusive, at Visit 1 and
             Visit 2

          -  Subject meets the DSM-5 criteria for a primary diagnosis of schizophrenia

          -  Subject is appropriate for outpatient treatment; has no hospitalizations for acute
             exacerbations of schizophrenia within 6 months before Visit 1

          -  Subject has maintained a stable body weight (change </= 5%) for at least 3 months
             prior to Visit 1 based on self-report

          -  Additional criteria may apply

        Exclusion Criteria:

          -  Subject has any of the following psychiatric conditions per DSM-5 criteria:

          -  Diagnosis of schizoaffective disorder or bipolar I or II disorder, or current,
             untreated or unstable major depressive disorder

          -  Clinically significant cognitive difficulties present within the past 2 years that
             could interfere with participation in the study

          -  Drug-induced or toxic psychosis

          -  Any other psychiatric condition that could interfere with participation in the study

          -  Subject poses a current suicide risk at Visit 1 or Visit 2 in the opinion of the
             investigator

          -  Subject has inflammatory bowel disease or any other gastrointestinal disorder
             associated with weight loss, anorexia nervosa, or binge eating disorder

          -  Additional criteria may apply
Saxagliptin Triple Oral Therapy
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Saxagliptin; Placebo
Intervention description: 5 mg tablet once daily for 24 weeks to be taken orally; tablet once daily for 24 weeks to be taken orally
Intervention MeSH terms: Saxagliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 257.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Type 2 Diabetes; Inadequate Glycaemic Control; Saxagliptin; Metformin; Sulfonylurea; Triple Oral Therapy

Summary:

      The purpose of this study is to determine whether the addition of saxagliptin to a patient's
      combination treatment of metformin and sulfonylurea for a 24 week period will provide better
      control of the patient's type 2 diabetes and will be well tolerated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written Informed Consent

          -  Males or females with type 2 diabetes with inadequate glycaemic control (HbA1c > or =
             7% and < or = 10%) despite being on combination of metformin and sulfonylurea for at
             least 8 weeks prior to Visit 1

          -  BMI < or = 40 kg/m2

        Exclusion Criteria:

          -  Symptoms of poorly controlled diabetes including but not limited to marked polyuria
             and marked polydipsia with > 10% weight loss in 3 months prior to entry, or other
             signs and symptoms

          -  History of diabetic ketoacidosis or hyperosmolar non-ketotic coma

          -  Current or prior use within 3 months of Visit 1 of insulin, DDP4 inhibitor, GLP-1
             analogues, and/or other oral anti-diabetic agents (other than metformin or
             sulfonylurea)

          -  Treatment with CYP3A4 inducers and/or potent CYP3A4/5 inhibitor

          -  Estimated CrCl < 60 ml/min at Visit 2

          -  CHF (NYHA class III or IV) and/or LVEF <40%

          -  Active liver disease and/or significant abnormal liver function defined as AST and/or
             ALT > 3 x ULN and/or bilirubin > 2.0 mg/dL at Visit 2.

          -  Creatine kinase > or = 10 x ULN at Visit 2
Total Hip Replacement Study Of GSK576428 (Fondaparinux Sodium)
Condition: Thrombosis, Venous
MeSH terms: Thrombosis; Venous Thrombosis
Intervention: Fondaparinux
Intervention MeSH terms: PENTA; Fondaparinux
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Enrollment: 114.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Fondaparinux; Hip Replacement Arthroplasty; VTE; THR; MOSLL; pentasaccharide; Xa factor

Summary:

      This study is requested by PMDA to confirm the optimal dose for THR (total hip replacement).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing either an elective primary THR (total hip replacement) surgery or
             a revision of a THR.

        Exclusion Criteria:

          -  Active, clinically significant bleeding (excluding drainage).
Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: BMS-663068; Placebo
Intervention description: BMS-663068; Placebo
Intervention MeSH terms: Fostemsavir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 371.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether the BMS Attachment Inhibitor (BMS-663068)
      is effective in the treatment of heavily treatment experienced HIV-1 patients with multi-drug
      resistance.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and non-pregnant women with chronic HIV-1 infection

          -  Antiretroviral-experienced with documented historical or baseline resistance,
             intolerability, and/or contraindications to antiretrovirals in at least three classes

          -  Failing current antiretroviral regimen with a confirmed plasma HIV-1 RNA ≥ 400 c/mL
             (first value from Investigator, second from Screening labs)

          -  Must have ≤ 2 classes with at least 1 but no more than 2 fully-active antiretrovirals
             remaining which can be effectively combined to form a viable new regimen, based on
             current and/or documented historical resistance testing and tolerability and safety

          -  Able to receive ≥ 1 fully active approved antiretroviral as part of the OBT from Day 9
             onwards in the Randomized Cohort

          -  Subjects without any remaining fully active approved antiretroviral may be enrolled in
             the Non-Randomized Cohort

        Exclusion Criteria:

          -  Chronic untreated Hepatitis B virus (HBV) (however, patients with chronic treated HBV
             are eligible)

          -  HIV-2 infection

          -  Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 7 x ULN

          -  Alkaline Phosphatase > 5 x ULN

          -  Bilirubin ≥ 1.5 x Upper limit of normal (ULN) (unless subject is currently on
             atazanavir and has predominantly unconjugated hyperbilirubinemia)
A Clinical Study to Investigate the Efficacy and Safety of Lacosamide as an Add on Therapy in Children With Epilepsy With Partial-onset Seizures
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Intervention: Lacosamide; Lacosamide
Intervention description: Pharmaceutical form: oral solution
Concentration: 1 mg/kg - 6 mg/kg BID (2 mg/kg/day - 12 mg/ kg/day)
Route of administration: oral use; Pharmaceutical form: tablet
Concentration: 50 mg - 300 mg BID (100 mg/day - 600 mg/day)
Route of administration: oral use
Intervention MeSH terms: Lacosamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 540.0
Sex: All
Minimum age: 1 Month
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Lacosamide; Vimpat; UCB; Epilepsy; Partial-Onset Seizures; Pediatric

Summary:

      The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of
      lacosamide (LCM) in pediatric subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved
             written Informed Consent form (ICF) is signed and dated by the subject or legal
             representative. The ICF or a specific Assent form, where required, will be signed and
             dated by minors

          -  Subject has completed the Transition Period of SP0967 [NCT02477839] or SP0969
             [NCT01921205] for the treatment of uncontrolled partial-onset seizures in pediatric
             epilepsy

          -  Subject is expected to benefit from participation, in the opinion of the investigator

          -  Subject/legal representative is considered reliable and capable of adhering to the
             protocol (eg, able to understand and complete diaries), visit schedule, and medication
             intake according to the judgment of the investigator

          -  Subject is male or female aged 1 month to ≤17 years

          -  Subject has a diagnosis of epilepsy with partial-onset seizures

        Exclusion Criteria:

          -  Subject is receiving any investigational drugs or using any experimental devices in
             addition to lacosamide (LCM)

          -  Subject meets a mandatory withdrawal criterion (ie, MUST withdraw criterion) for
             SP0967 or SP0969, or is experiencing an ongoing serious adverse event (SAE)

          -  For subjects ≥6 years of age, subject has a lifetime history of suicide attempt
             (including an actual attempt, interrupted attempt, or aborted attempt), or has
             suicidal ideation in the past 6 months as indicated by a positive response ('Yes') to
             either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS)
             at Visit 1

          -  Female subject who is pregnant or nursing, and/or a female subject of childbearing
             potential who is not surgically sterile or does not practice 1 highly effective method
             of contraception
Hyper- and Hypokalemic Periodic Paralysis Study
Condition: Hyperkalemic Periodic Paralysis; Hypokalemic Periodic Paralysis
MeSH terms: Hypokalemic Periodic Paralysis; Paralysis, Hyperkalemic Periodic; Paralysis
Intervention: Dichlorphenamide (double-blind); Placebo (double-blind); Dichlorphenamide (open-label)
Intervention description: 50mg tablet; maximum dosage 400mg/day; Inactive substance manufactured to look like Dichlorphenamide 50mg tablet; 50mg tablet; maximum dosage 400mg/day
Intervention MeSH terms: Dichlorphenamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: periodic paralysis; dichlorphenamide

Summary:

      The purpose of this study is to compare Dichlorphenamide with placebo (an inactive substance)
      for prevention of episodes and for improvement of strength in hyperkalemic (HYP) and
      hypokalemic (HOP) periodic paralysis. This study will also look at the long-term effects of
      Dichlorphenamide in periodic paralysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Genetically definite, clinically definite or clinically probable Hyperkalemic or
             Hypokalemic Periodic Paralysis as outlined in the protocol

          -  Male and female participants, age 18 and older who are able to comply with the study
             conditions.

          -  Participants who have distinct regular episodes of weakness with an average frequency
             of > or = to 1 a week and < or = to 3 a day either on or off treatment, whichever is
             higher

          -  Normal thyroid-stimulating hormone (TSH) level

        Exclusion Criteria:

          -  Evidence for Andersen-Tawil syndrome (any one of the following 3 criteria)

               1. Prolonged QT interval or complex ventricular ectopy between attacks

               2. Distinctive physical features (2 of the following 5)

                    1. Low set ears

                    2. Short stature

                    3. Hypo-/micrognathia

                    4. Clinodactyly

                    5. Hypo-/hypertelorism

               3. KIR 2.1 gene mutation

          -  Coincidental renal, hepatic, active thyroid disease, restrictive or obstructive lung
             disease, other neuromuscular disease, or heart disease

          -  Chronic, non-congestive, angle-closure glaucoma

          -  Use of any of the following medications for reasons other than treatment of periodic
             paralysis: diuretics, antiarrhythmics, corticosteroids, beta-blockers, calcium channel
             blockers, antiepileptics, magnesium

          -  History of life-threatening episodes of respiratory muscle weakness or cardiac
             arrhythmias during attacks

          -  Pregnancy

          -  Known mutation in the alpha subunit of the sodium channel gene in hypokalemic periodic
             paralysis patients
Safety of DTPa-IPV/Hib & DTPa-HBV-IPV/Hib, Followed by DTPa-IPV/Hib Vaccine in Infants Who Received Hepatitis B Vaccine
Condition: Haemophilus Influenzae Type b; Diphtheria; Tetanus; Poliomyelitis; Acellular Pertussis
MeSH terms: Diphtheria; Poliomyelitis
Intervention: DTPa-HBV-IPV/Hib; DTPa-IPV/Hib vaccine
Intervention description: 1 intramuscular injection (3rd study vaccine dose); 3 intramuscular injections (1st, 2nd and 4th vaccine dose)
Intervention MeSH terms: Edetic Acid; Pentetic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 702.0
Sex: All
Minimum age: 11 Weeks
Maximum age: 17 Weeks
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To assess the safety and reactogenicity of the DTPa-HBV-IPV/Hib vaccine and DTPa-IPV/Hib
      vaccine. This DTPa-IPV/Hib vaccine given at 3 and 4 months of age is co-administered with GSK
      Biologicals' rotavirus vaccine or Placebo. The Protocol Posting has been updated in order to
      comply with the FDA Amendment Act, Sep 2007.
    

Eligibility criteria:

        Inclusion criteria

          -  Subjects must have been enrolled in the Rota-028 study.

          -  Subjects for whom the investigator believes that their parents/guardians can and will
             comply with the requirements of the protocol should be enrolled in the study.

          -  A male or female between, and including, 11 and 17 weeks of age at the time of the
             first vaccination.

          -  Written informed consent obtained from the parent or guardian of the subject.

          -  Free of obvious health problems as established by medical history and clinical
             examination before entering into the study.

          -  Subjects should have received two doses of hepatitis B vaccine: at birth and at
             approximately one month of age.

        Exclusion criteria

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs during the study period.

          -  Planned administration/ administration of a vaccine not foreseen by the study protocol
             during the period starting from 30 days before each dose of the vaccine and ending 30
             days after.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, including
             human immunodeficiency virus (HIV) infection.

          -  A family history of congenital or hereditary immunodeficiency.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine.

          -  Major congenital defects or serious chronic illness.

          -  History of any neurologic disorders or seizures.

          -  Acute disease at the time of enrolment.

          -  Administration of immunoglobulins and/or any blood products since birth or planned
             administration during the study period.