bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Daclatasvir (DCV) in Combination With Sofosbuvir (SOF) in Children With Chronic Hepatitis C (CHC) Infection
Condition: Hepatitis C; Chronic Hepatitis
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: Daclatasvir; Sofosbuvir
Intervention description: Specified dose on specified days for specified duration; Specified dose on specified days for specified duration
Intervention MeSH terms: Sofosbuvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate daclatasvir in combination with sofosbuvir given to
      children with chronic hepatitis C infection
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Participants monoinfected with HCV genotype -1 to -6

          -  HCV RNA ≥1,000 IU/mL at Screening

          -  Participants who are HCV-treatment naïve or treatment experienced

          -  Participants in Cohort 1 must have a body weight ≥ 45kg at Day 1

        Exclusion Criteria:

          -  Mixed genotype HCV infections

          -  Evidence of an ongoing medical condition contributing to chronic liver disease other
             than HCV

          -  Evidence of cirrhosis, either compensated or decompensated

          -  Prior exposure to sofosbuvir and/or NS5A inhibitor

        Other protocol defined inclusion/exclusion criteria could apply
Efficacy of EGb761 in Patients Suffering From Friedreich Ataxia
Condition: Friedreich Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Friedreich Ataxia
Intervention: EGb 761 120 mg; Placebo
Intervention description: EGb 761® 120 mg bid, orally for 12 to 14 weeks; Placebo 1 tablet BID, orally for 12 to 14 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 22.0
Sex: All
Minimum age: 12 Years
Maximum age: 22 Years
Healthy volunteers: No

Summary:

      The purpose of this protocol is to determine the efficacy of EGb 761 120 mg bid versus
      placebo in patients suffering from Friedreich Ataxia
    

Eligibility criteria:

        Inclusion Criteria:

          -  Friedreich ataxia diagnosis confirmed by evidenced mutation expansion of Frataxin gene

          -  Ambulatory patient, with depressed tendon reflexes and pyramidal syndrome associated
             or not to a loss of position or vibration senses or dysarthria

          -  Patient able to perform the tests of the study

        Exclusion Criteria:

          -  Severe cardiac disease as assessed by echocardiography performed at least within 6
             months before screening or during the wash out period (4 weeks)

          -  Absolute contra-indication to Nuclear Magnetic Resonance spectroscopy(NMR)
             examination: iron and any magnetic objects implanted in the whole body, e.g. some
             neurostimulators, cardiac pace-makers, vascular clips and other implanted orthopaedic
             prosthesis

          -  Patient who did not deplete at baseline phosphocreatine (PCr) pool by more than 30 %
             during the exercise bout

          -  Any continuous use of the following forbidden medications:

          -  other antioxidant such as idebenone, coenzyme Q, vitamin E/C taken for less than 4
             weeks prior study treatment start (ie for antioxidant drugs a mandatory wash-out
             period of 4 weeks prior study drug start has to be observed),

          -  any other vasodilators

          -  tranquilizer such as benzodiazepine, meprobamate or buspirone, and/or antidepressant
             (only one), at non stable dose
Effect of Aromatase Inhibitors on Breast Magnetic Resonance Imaging (MRI)
Condition: Breast Cancer
Intervention: letrozole
Intervention description: Letrozole (12.5 mg/day ) which is higher than the dose routinely used for therapeutic indications is given for a brief duration (3 successive days) aiming to promote acute aromatase inhibition suitable for pre-diagnostic regimens.
Intervention MeSH terms: Letrozole
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: Female
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Letrozole; Breast MRI; Postmenopausal women

Summary:

      This study is a primary investigation to determine the usefulness and safety of a short
      course of a relatively high dose of letrozole (a medication used to decrease the female
      hormone estrogen which is produced locally inside the breast after menopause) in improving
      the performance of of breast MRI (Magnetic Resonance Imaging). The inhibition of estrogen in
      the breast by letrozole might help better identifying of suspicious areas in the breast and
      could assist radiologists in distinguishing between benign breast areas and cancer tissue.
      This might help reducing the rate of call backs and unnecessary biopsies for patients. We
      expect to enroll 20 healthy postmenopausal women in this study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women are eligible to participate if they are 40 years or older and have been
             menopausal (had no menstrual bleeding during the past 12 months)

        Exclusion Criteria:

          -  History of bilateral mastectomy, osteoporosis or renal impairment.
Study to Evaluate the Safety and Tolerability of GBT440 Administered to Subjects With IPF
Condition: Idiopathic Pulmonary Fibrosis; Hypoxemia
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis; Hypoxia
Intervention: GBT440; Placebo
Intervention description: Capsules which contain GBT440 drug substance in Swedish orange; Placebo capsules
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 39.0
Sex: All
Minimum age: 45 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study is a randomized, double-blind, placebo-controlled trial in which eligible IPF
      subjects will be randomized to receive GBT440 or Placebo orally daily.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented diagnosis of IPF.

          -  Oxygen desaturation with exercise.

          -  Completion of the baseline 6MWT

          -  Weight ≥ 50 kg

          -  Male or female of child bearing potential willing and able to use highly effective
             methods of contraception from study start to 3 months after the last dose of study
             drug.

        Exclusion Criteria:

          -  FEV1/FVC < 70%.

          -  Subjects on supplemental oxygen therapy at rest.

          -  History of other interstitial lung diseases.

          -  Significant polycythemia.

          -  Female who is breast-feeding or pregnant.

          -  Known current malignancy or history of malignancy within the last 2 years prior to
             screening.

          -  Use of cytotoxic and/or immunosuppressant medications within 30 days screening.

          -  Hospitalization due to an exacerbation of IPF within 30 days of screening

          -  Subject plans to begin or has commenced pulmonary rehabilitation within 30 days of
             screening

          -  Corticosteroids (> 10 mg per day of prednisone or an equivalent) within 30 days of
             screening.

          -  Current smoker or history of smoking within 3 months of screening.

          -  Currently or, in the opinion of the investigator, soon to be listed for lung
             transplant.

          -  History of unstable or deteriorating cardiac or pulmonary disease (other than IPF)
             within 6 months of screening.

          -  Any condition possibly affecting drug absorption.

          -  Participated in another clinical trial of an investigational drug (or medical device)
             within 30 days or 5-half-lives, whichever is longer, prior to screening, or is
             currently participating in another trial of an investigational drug (or medical
             device).

          -  Subject who, for any reason, is deemed by the investigator to be inappropriate for
             this study.
Study Of CP-751,871 In Combination With Exemestane In Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Intervention: CP-751,871; exemestane; exemestane; Fulvestrant
Intervention description: CP-751,871 given at 20 mg/kg IV on day 1 of each 21 day cycle.; Exemestane given at 25 mg orally once a day.; Exemestane given at 25 mg orally once a day. Treatment until progression or toxicity; Used for salvage therapy and administered according to the local label and standard clinical practice.
Intervention MeSH terms: Fulvestrant; Exemestane
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 219.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To test the efficacy of CP-751,871 combined with exemestane in the treatment of
      postmenopausal patients with hormone positive advanced breast cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal women with a diagnosis of hormone receptor positive advanced breast
             cancer

          -  HbA1c <5.7%

        Exclusion Criteria:

          -  Previous treatment for advanced disease
A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty
Condition: Venous Thromboembolism; Deep Vein Thrombosis; Total Knee Arthroplasty
MeSH terms: Thrombosis; Thromboembolism; Venous Thromboembolism; Venous Thrombosis
Intervention: DU-176b; DU-176b; DU-176b; DU-176b; Placebo
Intervention description: DU-176b 5mg tablets oral, once daily for 2 weeks; DU-176b 15mg tablets, oral once daily for 2 weeks; DU-176b 30 mg tablets, oral, once daily for 2 weeks; DU-176b 60 mg tablets, oral, once daily for 2 weeks; Matching placebo oral tablets, once daily for 2 weeks
Intervention MeSH terms: Edoxaban
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 523.0
Sex: All
Minimum age: 20 Years
Maximum age: 84 Years
Healthy volunteers: No
Keywords: prevention; venous thromboembolism; edoxaban; factor Xa

Summary:

      The objective of this study is to assess the efficacy, safety and dose-response relationship
      of DU-176b compared with placebo for the prevention of venous thromboembolism in patients
      after elective total knee arthroplasty.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing unilateral total knee arthroplasty

        Exclusion Criteria:

          -  risks of hemorrhage

          -  thromboembolic risks

          -  weight less than 40 kg

          -  pregnant, suspect pregnancy, or subjects who want to become pregnant
Injectable Diclofenac for the Prevention of Post-operative Dental Pain
Condition: Pain
Intervention: Diclofenac sodium
Intervention description: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
Intervention MeSH terms: Diclofenac
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: diclofenac, postsurgical pain, oral surgery

Summary:

      This is a prospective, randomised, double-blind, placebo-controlled, parallel group study in
      approximately 75 patients undergoing surgical removal of an impacted lower third molar.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Out-patients of either gender.

          2. Patients aged ≥ 18 to ≤ 65 years old.

          3. Subjects able and willing to give their written consent prior to inclusion in the
             study.

          4. Female subjects of childbearing potential must (1) have a negative urine pregnancy
             test at the inclusion visit, (2) be using an appropriate method of contraception
             according to the definition of Note of ICH M3 Guideline (implants, injectables,
             combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner),
             and (3) be willing to continue using the contraceptive method throughout the entire
             study period.

          5. Subjects must (1) be able to comprehend the full nature and purpose of the study,
             including possible risks and side effects, (2) fully co-operate with the Investigator,
             (3) comply with the requirements of the entire study.

          6. Patients undergoing surgical extraction of a single, fully or partially impacted
             mandibular 3rd molar requiring bone removal.

        Exclusion Criteria:

        General

          1. Patients refusing to give written informed consent.

          2. Patients not able to understand the purposes of the study or not willing to return for
             the control visits.

          3. Patients with major psychiatric disorders that, in the investigator's opinion, could
             compromise study participation.

          4. Patients enrolled in any clinical trial in the previous 3 months.

          5. Employees of the study centre with direct involvement in the proposed study or other
             studies under the direction of the main investigator or study centre, as well as
             family members of the employees or investigator.

          6. Pregnant or breast-feeding women.

          7. Alcohol or drug abuse in the previous 12 months.

          8. Clinically significant or unstable concomitant disease whose sequelae might interfere
             with the study evaluation parameters.
Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Advanced or Recurrent Esophageal Cancer
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Intervention: Paclitaxel
Intervention MeSH terms: Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Healthy volunteers: No

Summary:

      The purpose of this study is to provide access to paclitaxel therapy to subjects with
      advanced or recurrent esophageal cancer who have completed the previous Phase 2 study
      (CA139-540) and who should continue on therapy with paclitaxel as assessed by the treating
      investigator(s). To evaluate the severity of observed adverse reactions in treated subjects
      for assessment of long-term safety.
    

Eligibility criteria:

        Subjects with advanced or recurrent esophageal cancer who have completed the previous late
        Phase 2 study (CA139-540) and for who continued therapy with paclitaxel would be beneficial
        as deemed by the investigator(s).
Protection of the Heart With Doxycycline During Coronary Artery Bypass Grafting
Condition: Coronary Artery Bypass Grafting; Cardiopulmonary Bypass; Reperfusion Injury
MeSH terms: Reperfusion Injury
Intervention: Periostat; Placebo Oral Tablet
Intervention description: In addition to standard care, patients received oral administration of 20 mg of doxycycline twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3.; In addition to standard care, patients received oral administration of placebo twice a day at least 2 days prior to surgery, on the day of surgery, and on postoperative days 1, 2, and 3.
Intervention MeSH terms: Doxycycline
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Doxycycline; coronary artery bypass grafting

Summary:

      The purpose of this study is to determine whether doxycycline (Periostat) at a
      sub-antimicrobial dose will decrease reperfusion injury after coronary artery bypass grafting
      (CABG) surgery with cardiopulmonary bypass (CPB).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent

          -  Aged 18 through 80 years, inclusive

          -  Scheduled for primary CABG surgery with CPB

        Exclusion Criteria:

          -  Females of childbearing potential

          -  Emergency CABG

          -  Previous sternotomy

          -  Planned simultaneous surgery (i.e. valve repair or carotid endarterectomy)

          -  Myocardial infarction within 48 hours

          -  Pre-operative atrial fibrillation

          -  Pre-operative ventricular pacing or left bundle branch block (LBBB)

          -  Known hypersensitivity to tetracycline class antibiotics

          -  Renal failure requiring dialysis
Facilitation of NMDA Receptor Function in Patients With Schizophrenia and Co-morbid Alcoholism
Condition: Alcoholism; Schizophrenia
MeSH terms: Alcoholism; Schizophrenia
Intervention: Glycine; placebo
Intervention description: Glycine, 0.8 gr per kg given in two daily doses
Intervention MeSH terms: Glycine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 20.0
Sex: All
Minimum age: 21 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: glycine; treatment; alcohol dependence; schizophrenia

Summary:

      This placebo-controlled study is designed to evaluate the efficacy of glycine, an agonist of
      the glycine-B co-agonist site of the NMDA receptor, on alcohol consumption and craving as
      well as negative symptoms in schizophrenia.

      Glycine will decrease the rewarding action of ethanol and reduce ethanol consumption. Also,
      glycine will improve negative symptoms and cognitive deficits in schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  DSM-IV diagnosis of schizophrenia or schizoaffective disorder

          -  DSM-IV diagnosis of alcohol dependence

          -  Stable treatment with typical or atypical antipsychotics

        Exclusion Criteria:

          -  Axis I diagnosis other than alcohol dependence, schizophrenia, schizoaffective
             disorder, OCD, and PTSD.

          -  current drug dependence

          -  evidence of significant hepatocellular injury evidence by abnormal SGOT or SGPT levels

          -  history of seizures

          -  diabetes and medical conditions that would alter glycine metabolism

          -  positive pregnancy test

          -  treatment with clozapine, naltrexone or disulfiram
A Phase 2, Multicenter, Open-label Study of MEDI-551 in Adults With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
Condition: Chronic Lymphocytic Leukemia (CLL)
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Rituximab; Bendamustine; MEDI-551
Intervention description: Rituximab was administered by IV infusion as a dose of 375 mg/m^2 on Day 2 of Cycle 1 and then at 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycles; Bendamustine was administered by IV infusion as a dose of 70 mg/m^2 on Day 1 and Day 2 of each 5 subsequent 28-day cycle.; MEDI-551 was administered at 2 mg/kg or 4 mg/kg by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycles.
Intervention MeSH terms: Rituximab; Bendamustine Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 183.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Chronic lymphocytic leukemia; leukemia; B-Cell malignancy; anti-CD19; monoclonal antibody; CLL; Refractory; Relapse; Non-Hodgkin's Lymphoma

Summary:

      The overall purpose of the study was to determine if MEDI-551, when used in combination with
      salvage chemotherapy (bendamustine) in participants with relapsed or refractory CLL who are
      not eligible for Autologous Stem Cell Transplant (ASCT), had superior efficacy compared to
      rituximab in the same population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed B-cell Chronic Lymphocytic Leukemia (CLL) according to the
             National Cancer Institute criteria; Eastern Cooperative Oncology Group (ECOG)
             performance status of 0, 1, or 2; Adequate hematological function

        Exclusion Criteria:

          -  Any chemotherapy, radiotherapy, immunotherapy, biologic, investigational, or hormonal
             therapy for treatment of lymphoma within 28 days prior to treatment;

          -  Exposure to bendamustine within the 180 days before study enrollment

          -  Prior autologous or allogeneic stem cell transplantation (SCT);

          -  Clinically significant abnormality on electrocardiogram (ECG) as determined by the
             treating physician or medical monitor;

          -  History of other invasive malignancy within 5 years except for localized/in situ
             carcinomas;

          -  Evidence of active infection, Confirmed current central nervous system involvement by
             leukemia or lymphoma;
Safety and Efficacy of Cyclosporine Ophthalmic Emulsion in Patients With Primary Pterygium
Condition: Pterygium
MeSH terms: Pterygium
Intervention: cyclosporine ophthalmic emulsion 0.05%; Vehicle
Intervention description: One drop in the study eye (or eyes) administered four times daily (QID); One drop in the study eye (or eyes) administered four times daily (QID)
Intervention MeSH terms: Cyclosporine; Cyclosporins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 115.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of Cyclosporine Ophthalmic Emulsion 0.05%
      (RESTASIS®) in patients with primary pterygium (abnormal growth on surface of eye).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a pterygium in at least one eye that has not been previously removed with surgery

        Exclusion Criteria:

          -  Uncontrolled systemic disease

          -  Active eye disease

          -  Current or anticipated use of topical eye medications other than artificial tears.

          -  Anticipated wearing of contact lenses