bioihbjkbjnl/mcl2 huggingface dataset:
Follow-up Trial to Evaluate Long-term Safety and Efficacy of Brivaracetam in Subjects Suffering From Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Brivaracetam (ucb 34714)
Intervention description: 10 mg and 25 mg tablets. Flexible dosing up to 200 mg/day, twice daily. For each subject, the study will last from study entry until either regulatory approval of brivaracetam has been granted by any Health Authority in an indication of adjunctive treatment of partial onset seizures; or until the Sponsor decides to close the study; until a managed access program, named patient program, compassionate use program, or similar type of access program is established as allowed per country-specific requirements in addition to legal and regulatory guidelines, or until the investigational product development is stopped by the Sponsor.
Intervention MeSH terms: Brivaracetam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 853.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Brivaracetam; Epilepsy; long term

Summary:

      This trial, evaluating the long-term safety and tolerability of brivaracetam, will give
      subjects suffering from epilepsy, who may have benefited from brivaracetam, the opportunity
      to continue the treatment. The study will also evaluate the maintenance of efficacy over time
      of brivaracetam for subjects with partial onset seizures (POS)/primary generalized seizures
      (PGS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male/female subjects from 16 years (where legally permitted and ethically accepted) or
             18 years onwards suffering from epilepsy and having completed a previous study with
             brivaracetam as adjunctive treatment, which allowed access to this study

          -  Subjects with POS/PGS: inpatients or outpatients with epilepsy who participated in
             previous brivaracetam studies / programs which allow access to the present study

          -  Subjects with ULD: inpatients or outpatients with epilepsy who were treated with
             brivaracetam in previous studies / programs which allow access to the present study

          -  Subjects for whom the Investigator believes a reasonable benefit from the long-term
             administration of brivaracetam may be expected

        Exclusion Criteria:

          -  Severe medical, neurological and psychiatric disorders, or laboratory values which may
             have an impact on the safety of the subject

          -  Poor compliance with visit schedule or medication intake in previous brivaracetam
             study

          -  Participation in any clinical study of another investigational drug or device during
             the study

          -  Pregnant or lactating woman
Study of Pyridoxine for Hand-Foot Syndrome
Condition: Hand-foot Syndrome
MeSH terms: Hand-Foot Syndrome; Syndrome
Intervention: Pyridoxine; Placebo
Intervention description: 100mg BID/daily, Per oral; placebo 100mg BID/daily, Per oral
Intervention MeSH terms: Pyridoxine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 389.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: hand-foot syndrome; capecitabine; pyridoxine; prevention

Summary:

      Although pyridoxine has been used empirically for the prevention of capecitabine associated
      hand-foot syndrome (HFS), its efficacy needs to be demonstrated in prospective controlled
      trials. The investigators therefore performed a prospective randomized double-blind study to
      determine whether pyridoxine 200 mg/day can prevent the development of HFS when given
      concurrently with capecitabine. The investigators also tested the ability of pyridoxine to
      treat primary occurrence of grade 2-3 HFS.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Gastrointestinal tract cancer patients treated with capecitabine-containing
             chemotherapy as a first-line treatment were randomly allocated to concurrent treatment
             with pyridoxine or placebo.

          -  All patients were 18 to 70 years old

          -  Had Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower

          -  An estimated life expectancy > 3 months

          -  Adequate bone marrow function, including white blood cell (WBC) count of >3500 cells/㎕
             and platelet count of >100000/㎕

          -  Adequate renal function (serum creatinine concentration <1.5 mg/㎗)

          -  Adequate liver function with (serum bilirubin concentration <1.5 mg/㎗, transaminase <3
             times the upper normal limit, and serum albumin >2.5 mg/㎗).

        Exclusion Criteria:

          -  Previous treatment for HFS

          -  Hypersensitivity to pyridoxine

          -  A combination of other malignancies

          -  Serious illnesses or medical conditions

          -  Immune suppression or positive human immunodeficiency virus (HIV) serology

          -  Pregnant or lactating women.
Extension Study of Idelalisib in Participants With Chronic Lymphocytic Leukemia (CLL) Who Participated in GS-US-312-0116 (NCT01539512)
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Idelalisib
Intervention description: Idelalisib tablet(s) administered orally twice daily
Intervention MeSH terms: Idelalisib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 161.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CLL; CAL-101; CAL 101; GS-1101; GS 1101; PI3K; Leukemia; GS-US-312-0116; idelalisib

Summary:

      The primary objective of this extension study (GS-US-312-0117) that is a companion study to
      Study GS-US-312-0116 (NCT01539512), is to evaluate the effect of idelalisib on the onset,
      magnitude, and duration of tumor control. Randomization was done in study GS-US-312-0116, and
      carried forward to study GS-US-312-117.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Individuals in the primary Phase 3 study (Study GS-US-312-0116) who are compliant

          -  Tolerating primary study therapy

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: pemetrexed; docetaxel; carboplatin
Intervention description: 500 mg/m^2, IV, q 21 days x 6 cycles maximum; 75 mg/m^2, IV, q 21 days x 6 cycles maximum; AUC 5 mg*min/mL, IV, q 21 days x 6 cycles maximum
Intervention MeSH terms: Carboplatin; Docetaxel; Pemetrexed
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 260.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the combination of pemetrexed and carboplatin with
      the combination of docetaxel and carboplatin in terms of survival without Grade 3 or 4
      toxicity in previously untreated patients with locally advanced or metastatic non-small cell
      lung cancer (NSCLC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient with locally advanced or metastatic (Stage IIIB/IV) NCSLC with no prior
             chemotherapy for advanced disease or molecular target treatment

          -  Easter Cooperative Oncology Group (ECOG) performance status 0 to 2

          -  Estimated life expectancy of at least 8 weeks

        Exclusion Criteria:

          -  Known or suspected brain metastases

          -  Concurrent administration of any other tumor therapy

          -  Serious concomitant disorders

          -  Pregnancy or breast feeding

          -  Inability or unwillingness to take folic acid or vitamin B12 supplementation
Phase 3 Study of Immunotherapy to Treat Advanced Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Ipilimumab; Placebo
Intervention description: 5 mg/ml solution, Intravenous, 10 mg/kg, Every 3 weeks for up to 4 doses in the Induction Phase. Every 12 weeks in the Maintenance Phase. Up to 24 weeks in the Induction Phase. Treatment in the Maintenance Phase continues until total treatment period has reached three years,Treatment Stopping Criteria are met, withdrawal of consent, or study closure; Solution, Intravenous, 0 mg, Every 3 weeks for up to 4 doses in the Induction Phase. Every 12 weeks in the Maintenance Phase. Up to 24 weeks in the Induction Phase. Treatment in the Maintenance Phase continues until total treatment period has reached three years,Treatment Stopping Criteria are met, withdrawal of consent, or study closure
Intervention MeSH terms: Ipilimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 837.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if asymptomatic or minimally symptomatic patients
      with metastatic prostate cancer who have not received chemotherapy live longer when treated
      with ipilimumab than those treated with a placebo
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Metastatic prostate cancer

          -  Asymptomatic or minimally symptomatic

          -  Progression during hormonal therapy

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1

        Exclusion Criteria:

          -  Liver, lung or brain metastases

          -  Prior immunotherapy or chemotherapy for metastatic prostate cancer

          -  Autoimmune disease

          -  HIV, Hepatitis B, or Hepatitis C infection
Aripiprazole for Schizophrenia Outpatients Completing BMS Clinical Trials
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Aripiprazole
Intervention description: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country
Intervention MeSH terms: Aripiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 119.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to provide aripiprazole to schizophrenic outpatients and
      Community Treated Patients who are currently receiving aripiprazole therapy on another BMS
      sponsored clinical trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Currently receiving aripiprazole at time of screening

          -  Men and women ages 18 to 70

        Exclusion Criteria:

          -  All patients previously discontinued from an aripiprazole study for any reason

          -  Active alcohol or substance abuse

          -  Patients who represent a significant risk of committing suicide

          -  Patients with clinically significant abnormal laboratory test results, vital signs or
             ECG findings
A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Ocrelizumab
Intervention description: Ocrelizumab will be administered as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
Intervention MeSH terms: Ocrelizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 681.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      The purpose of this prospective, multicenter, open-label, efficacy, and safety study is to
      assess the efficacy and safety of ocrelizumab in participants with Relapsing Remitting
      Multiple Sclerosis (RRMS) who have had a suboptimal response to an adequate course of a
      Disease-Modifying Treatment (DMT). The study will consist of a Screening period (up to 4
      weeks), an Open-label treatment period (96 weeks; with last dose administered at Week 72),
      and a Follow-up period of at least 2 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a definite diagnosis of RRMS, confirmed as per the revised McDonald 2010 criteria

          -  Have a length of disease duration, from first symptom, of less than (<) 10 years

          -  Have received no more than two prior DMTs, and the discontinuation of the most recent
             DMT was due to lack of efficacy

          -  Suboptimal disease control while on a DMT

          -  Expanded Disability Status Scale (EDSS) of 0.0 to 4.0, inclusive, at Screening

          -  For women of childbearing potential: agreement to use an acceptable birth control
             method during the treatment period and for at least 6 months after the last dose of
             study drug

        Exclusion Criteria:

          -  Secondary progressive multiple sclerosis (SPMS) or history of primary progressive or
             progressive relapsing multiple sclerosis (MS)

          -  Inability to complete an Magnetic Resonance Imaging (MRI) procedure

          -  Known presence of other neurological disorders

          -  Any concomitant disease that may require chronic treatment with systemic
             corticosteroids or immunosuppressants during the course of the study

          -  History or currently active primary or secondary immunodeficiency

          -  History of severe allergic or anaphylactic reactions to humanized or murine monoclonal
             antibodies

          -  History of opportunistic infections

          -  History or known presence of recurrent or chronic infection

          -  History of malignancy

          -  Congestive heart failure

          -  Known active bacterial, viral, fungal, mycobacterial infection or other infection,
             excluding fungal infection of nail beds
Efficacy of Atazanavir/Ritonavir Monotherapy as Maintenance in Patients With Viral Suppression
Condition: HIV-1 Infection
Intervention: Atazanavir/ritonavir monotherapy
Intervention description: Monotherapy Simplification Strategy with Atazanavir/ritonavir 300/100 mg once daily for 96 weeks.
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 117.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: HIV-1

Summary:

      The study will assess whether Atazanavir/ritonavir monotherapy provides a non-inferior
      proportion of virological efficacy with respect to ATV/RTV + 2 NRTIs in patients with stable
      suppressed viremia and no prior virologic failures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV infected patients

          -  age > 18 years

          -  On treatment with ATV/r plus 2 NRTIs for at least 48 weeks

          -  Virological suppression (HIV-RNA<50 c/ml) by at least 24 weeks with ATV/r plus 2 NRTIs

          -  No virologic failure after the initiation of the first antiretroviral therapy.
             Previous treatment changes due to toxicity or treatment simplifications will be
             permitted only if occurred with documented virological suppression.

          -  CD4 cells nadir >100 cells/µL

          -  PPI and H2-receptor antagonists as follows: the proton-pump inhibitors should not be
             used; if H2-receptor antagonists are co-administered, a dose equivalent to famotidine
             20 mg BID should not be exceeded.

        Exclusion Criteria:

          -  Pregnancy and breast feeding women

          -  AIDS defining events

          -  Evidence of active HBV infection (HBsAg positive)

          -  Previous virological failure

          -  History of resistance to ATV

          -  Use of contraindicated medications
Efficacy and Safety of Intravenous Acetaminophen Over 48 Hrs for the Treatment of Post-op Pain After Gynecologic Surgery
Condition: Postoperative Pain; Hysterectomy
MeSH terms: Pain, Postoperative
Intervention: IV Acetaminophen; IV Placebo 100 mL solution
Intervention description: Intravenous acetaminophen 1 g/100 mL; IV Placebo 100 mL solution dosed at same frequency as IV Acetaminophen every 6 hours (q6h)
Intervention MeSH terms: Acetaminophen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 331.0
Sex: Female
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Pain; Gynecologic; IV Acetaminophen; Postoperative; Analgesic

Summary:

      This study will be investigating the efficacy and safety administration of multiple doses of
      intravenous (IV) acetaminophen (IVAPAP) in the 48 hour period following Gynecologic Surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Undergo gynecologic surgery using standard abdominal approach such as midline or
             Pfannenstiel incision

          -  18-75 years of age

          -  Body Mass Index (BMI) between 19-45

          -  American Society of Anesthesiologists (ASA) risk class of I, II, III

          -  Not have received neuraxial (spinal or epidural) opioid analgesics prior to or during
             surgery

          -  Moderate to Severe pain at rest

        Exclusion Criteria:

          -  Requires any additional surgical procedures either related or unrelated to gynecologic
             surgery during same hospitalization

          -  Procedures involving only minimal incisions such as laparotomy, laparoscopy,
             supraumbilical or Maylard incisions

          -  Has know hypersensitivity to opioids, acetaminophen, or the excipients of IV
             acetaminophen

          -  Known history of alcohol or drug abuse or misuse

          -  Has impaired liver function Aspartate transaminase(AST), Alanine
             aminotransferase(ALT), bilirubin greater than or equal to 2 times upper limit of
             normal

          -  Has significant medical disease(s), or conditions that may contraindicate
             participation in the study

          -  Has participated in another clinical trial within 30 days of surgery
Clinical Study to Assess the Efficacy and Safety of G238 Compared to Clotrimazole Otic Solution in the Treatment of Otomycosis
Condition: Otomycosis
MeSH terms: Otomycosis
Intervention: G238; Clotrimazole
Intervention description: Five drops into the ear canal twice daily for 14 days; Five drops into the ear canal twice daily for 14 days
Intervention MeSH terms: Clotrimazole; Miconazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 190.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of G238 for the treatment of
      otomycosis
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years or older.

          -  Clinical diagnosis of otomycosis where topical treatment is indicated.

        Exclusion Criteria:

          -  Other ear diseases.
Oral Progesterone for Prevention of Preterm Birth
Condition: Preterm Birth
MeSH terms: Premature Birth
Intervention: oral micronized progesterone; Identical Placebo tablet
Intervention description: oral micronized progesterone = 400 mg oral micronized progesterone nightly from 16 to 34 weeks; Identical Placebo tablet = placebo taking nightly from 16 to 34 weeks
Intervention MeSH terms: Progesterone
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 36.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Preterm birth, prevention, progesterone, oral

Summary:

      To evaluate whether daily oral micronized progesterone is effective in preventing recurrent
      spontaneous preterm birth (RSPB) and whether micronized progesterone use increases maternal
      serum progesterone levels.
    

Eligibility criteria:

        Inclusion Criteria:

          -  pregnant women less than 20 weeks' gestation who had at least one prior spontaneous
             preterm birth of a liveborn baby between 20 & 0/7 weeks' and 36 & 6/7 weeks'
             gestation.

        Exclusion Criteria:

          -  multiple gestations, the presence of major fetal anomalies, progesterone use in the
             current pregnancy (ongoing or past), the presence of a cervical cerclage, and the
             presence of a placenta previa.
Evaluation of Safety and Tolerability of Creon Micro in Children Younger Than Four Years With Pancreatic Exocrine Insufficiency
Condition: Pancreatic Exocrine Insufficiency
MeSH terms: Exocrine Pancreatic Insufficiency
Intervention: Pancreatin
Intervention description: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
Intervention MeSH terms: Pancreatin; Pancrelipase
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Maximum age: 4 Years
Healthy volunteers: No
Keywords: cystic fibrosis

Summary:

      The purpose of this study is to evaluate the safety and tolerability of Creon micro in
      children younger than four years with pancreatic exocrine insufficiency.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children younger than four years with confirmed cystic fibrosis diagnosis and a body
             weight of at least 2 kilograms

        Exclusion Criteria:

          -  Ileus or acute abdomen

          -  history of fibrosing colonopathy

          -  history of distal ileal obstruction without surgery

          -  solid organ transplant or surgery affecting the large bowel, other than appendectomy