bioihbjkbjnl/mcl2 huggingface dataset:
Extension Study of TKT028 Evaluating Safety and Clinical Outcomes of Replagal® in Adult Patients With Fabry Disease
Condition: Fabry Disease
MeSH terms: Fabry Disease
Intervention: Replagal
Intervention description: 0.2 mg/kg administered intravenously [IV] every other week
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Agalsidase alfa; Alpha-Galactosidase; Replagal; Enzyme Replacement Therapy

Summary:

      This study will evaluate safety and clinical outcomes of treatment with Replagal in adult
      participants with Fabry disease who have completed Study TKT028 (NCT00864851).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Complete all study requirements and assessments for Study TKT028 less than 30 days
             (+/- 7 days) prior to the first dose in this extension protocol

          -  Voluntarily signed an Institutional Review Board/Independent Ethics Committee-
             approved informed consent form after all relevant aspects of the study have been
             explained and discussed.

          -  Has received and tolerated at least 80% of the total planned Replagal infusions in
             Study TKT028

          -  Female participants of child-bearing potential must agree to use a medically
             acceptable method of contraception at all times during the study and must have a
             negative pregnancy test at the time of study entry and as required throughout
             participation in study

        Exclusion Criteria:

          -  Has received treatment with any investigational drug (other than Replagal) or device
             within 30 days prior to study entry.

          -  Is unable to comply with the protocol, (eg, is unable to return for safety
             evaluations, or is otherwise unlikely to complete the study), as determined by the
             Investigator

          -  Has a positive test for hepatitis B surface antigen (HBsAg), hepatitis C(HCV)
             antibody, or human immunodeficiency virus (HIV) antibody

          -  Is pregnant or lactating

          -  Is morbidly obese, defined as body mass index (BMI) >39 kg/m2

          -  Has any safety or medical issues, as assessed by the Investigator, that contraindicate
             participation in the study (eg, has experienced an adverse reaction to treatment with
             Replagal or has a known hypersensitivity to any of the components of Replagal
Stimulant Abuser Groups to Engage in 12-Step
Condition: Drug Abuse
MeSH terms: Substance-Related Disorders
Intervention: STAGE-12; Treatment as Usual
Intervention description: The STAGE-12 intervention will consist of a combination of five group and three individual sessions. The five group sessions will be taken from the Project MATCH Twelve Step Facilitation manual as modified for use with drug abusers and adapted for delivery in a group format. The group sessions will be augmented by three individual sessions derived from the introductory and termination sessions from the TSF manual and incorporating elements of the brief intensive 12-step referral procedure.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 471.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cocaine, methamphetamine, amphetamine, other stimulant drugs

Summary:

      The purpose of this study is to determine whether a combined group and individual 12-Step
      facilitative (TSF) intervention, Stimulant Abuser Groups to Engage in 12 -Step (STAGE-12),
      improves substance -related outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  seeking outpatient treatment for stimulant abuse or dependence

          -  current diagnosis of stimulant abuse or dependence

          -  willing to participate in the protocol

        Exclusion Criteria:

          -  not sufficiently medically or psychiatrically stable

          -  pending legal action that would inhibit their participation in the study

          -  in need of detoxification from opiates
Long-term Deferiprone Treatment in Patients With Pantothenate Kinase-Associated Neurodegeneration
Condition: Pantothenate Kinase-Associated Neurodegeneration
MeSH terms: Pantothenate Kinase-Associated Neurodegeneration; Nerve Degeneration
Intervention: Deferiprone oral solution
Intervention description: Deferiprone oral solution at a dosage of up to 15 mg per kilogram of body weight, twice a day
Intervention MeSH terms: Deferiprone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: All participants in this study received the same intervention.
Masking: None (Open Label)
Enrollment: 68.0
Sex: All
Minimum age: 5 Years
Healthy volunteers: No
Keywords: Pantothenate Kinase-Associated Neurodegeneration; PKAN; Neurodegeneration with Brain Iron Accumulation; NBIA; Deferiprone; Ferriprox

Summary:

      Patients with PKAN will be treated with the iron chelator deferiprone for 18 months. Only
      patients who have completed the earlier study TIRCON2012V1 (NCT01741532), a double-blind
      placebo-controlled trial in which participants were randomized to receive either deferiprone
      or placebo for 18 months, are eligible to enroll.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed study TIRCON2012V1

        Exclusion Criteria:

          -  Withdrew from the study TIRCON2012V1 for reasons of safety

          -  Plan to participate in another clinical trial at any time from the day of enrolment
             until 30 days post-treatment in the current study
Anidulafungin Candidemia/Invasive Candidiasis Intensive Care Study
Condition: Invasive Candidiasis
MeSH terms: Candidiasis; Candidemia; Candidiasis, Invasive
Intervention: Anidulafungin; Fluconazole; Voriconazole
Intervention description: Anidulafungin Intravenous Administration; Oral Administration of Fluconazole; Oral Administration of Voriconazole
Intervention MeSH terms: Fluconazole; Voriconazole; Anidulafungin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 216.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Candida; Candidemia; Systemic Candidiasis; ICU; Intensive Care Unit; Critical Care Unit; Anidulafungin; Ecalta; Eraxis; Fluconazole; Voriconazole

Summary:

      To evaluate the efficacy and safety of anidulafungin in the treatment of systemic fungal
      infections in intensive care and critical care unit patients.
    

Eligibility criteria:

        Inclusion Criteria:

        ICU patients with a diagnosis of documented candidemia or invasive candidiasis and
        belonging to one or more of the following specific populations:

          -  Post-abdominal surgery.

          -  Elderly > 65 years old.

          -  Renal insufficiency / failure / hemodialysis.

          -  Solid tumor.

          -  Solid-organ (liver, kidney, lung, heart) transplant recipients.

          -  Hepatic insufficiency.

          -  Neutropenic including hematology oncology patients.

        Exclusion Criteria:

        Patients with poor venous access that would preclude IV drug delivery or multiple blood
        draws.
Safety & Efficacy Study Evaluating the Combination of Bevasiranib & Lucentis Therapy in Wet AMD
Condition: Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: bevasiranib; ranibizumab
Intervention description: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks; Lucentis® (0.5 mg)administered intravitreally every 4 weeks.
Intervention MeSH terms: Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 338.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: AMD; Macular Degeneration; bevasiranib; COBALT study; age related macular degeneration; wet AMD; wet age related macular degeneration

Summary:

      The purpose of this study is to compare the safety and effectiveness of bevasiranib given
      either every 8 weeks or every 12 weeks after an initial pre-treatment with 3 injections of
      Lucentis® (ranibizumab injection) compared to Lucentis® given every 4 weeks to people with
      wet AMD. Patients will be assigned at random (like tossing a coin) to receive one of three
      treatments options for 104 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients must be age 50 years or older

          2. Patients must have predominantly classic, minimally classic or occult with no classic
             lesions secondary to Age Related Macular Degeneration.

          3. The study eye must have ETDRS best corrected visual acuity of 69 to 24 letters (20/40
             to 20/320 Snellen equivalent).

          4. Patients must be willing and able to return for scheduled monthly follow-up visits for
             two-years.

        Exclusion Criteria:

          1. Prior pharmacologic treatment for AMD in the study (patients can not have previously
             received Avastin®/Lucentis®, Macugen®, or any other anti-VEGF agents, steroid
             treatments, PDT, radiation treatment, or any experimental therapies for AMD in the
             study eye)

          2. Any intraocular surgery of the study eye within 12 weeks of screening

          3. Previous posterior vitrectomy of the study eye

          4. Advanced glaucoma or intraocular pressure above 22 mm Hg in the study eye despite
             treatment.
Aprepitant + a 5HT3 + Dexamethasone in Patients With Germ Cell Tumors
Condition: Germ Cell Tumors
MeSH terms: Neoplasms, Germ Cell and Embryonal
Intervention: Aprepitant; Placebo
Intervention description: Subjects will be randomized to receive aprepitant 125mg PO day 3 then 80mg on days 4-7 on either cycle 1 or cycle 2.; Subjects will be randomized to receive placebo on days 3-7 on either cycle 1 or cycle 2.
Intervention MeSH terms: Aprepitant
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 69.0
Sex: Male
Minimum age: 15 Years
Healthy volunteers: No

Summary:

      Aprepitant is currently approved for prophylaxis of acute and delayed CINV for highly
      emetogenic chemotherapy regimens, including cisplatin; however, it has not yet been studied
      in multiple-day chemotherapy treatment programs. This study will compare the addition of
      aprepitant compared to placebo administered on days 3,4,5 of chemotherapy administration for
      acute CINV prophylaxis with standard antiemetic prophylaxis and days 6 and 7 for delayed CINV
      prophylaxis in a double-blind, randomized, crossover study design.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic, serologic or clinical evidence of germ cell tumor.

          -  Patients scheduled to receive a 5 day fractionated cisplatin-based combination
             chemotherapy on permitted regimens

          -  Prior chemotherapy is allowed. Patients will be stratified based on previous
             treatment.

          -  Male patients 15 years of age or older at time of registration.

          -  Patient will provide written informed consent and authorization to release personal
             health information.

        Exclusion Criteria:

          -  No known history of anticipatory nausea or vomiting.

          -  No use of another antiemetic agent within 72 hours prior to beginning chemotherapy.

          -  No known central nervous system (CNS) metastasis.

          -  No known hypersensitivity to any component of study regimen.

          -  No concurrent participation in a clinical trial which involves another investigational
             agent.

          -  No use of warfarin while on study.

          -  No use of agents expected to induce the metabolism of aprepitant which include:
             Rifampin, Rifabutin, Phenytoin, Carbamazepine, and barbiturates.

          -  No use of agents which may impair metabolism of aprepitant which include: Cisapride,
             macrolide antibiotics (Erythromycin, Clarithromycin, Azithromycin), azole antifungal
             agents (Ketoconazole, Itraconazole, Voriconazole, Fluconazole), Amifostine, Nelfinavir
             and Ritonavir.
Women's Health Study (WHS): A Randomized Trial of Low-dose Aspirin and Vitamin E in the Primary Prevention of Cardiovascular Disease and Cancer
Condition: Cardiovascular Diseases; Cerebrovascular Disorders; Coronary Disease; Heart Diseases; Myocardial Infarction; Myocardial Ischemia; Vascular Diseases
MeSH terms: Cerebrovascular Disorders; Cardiovascular Diseases; Heart Diseases; Myocardial Infarction; Vascular Diseases; Coronary Disease; Myocardial Ischemia; Infarction; Ischemia
Intervention: Aspirin; Vitamin E; Placebo
Intervention description: Participants will receive 100 mg of aspirin every other day.; Participants will receive 600 IU of vitamin E every other day.; Participants will receive placebo.
Intervention MeSH terms: Aspirin; Vitamin E
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 39876.0
Sex: Female
Minimum age: 45 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the effects of low-dose aspirin and vitamin E in
      primary prevention of cardiovascular disease and cancer in apparently healthy women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy women

          -  No previous history of cardiovascular disease or cancer

          -  No contraindications to aspirin or vitamin E
Trial of Adjuvant Chemotherapy for Gastric Cancer
Condition: Stomach Cancer
MeSH terms: Stomach Neoplasms
Intervention: Mitomycin, doxifluridine and cisplatin; Mitomycin and doxifluridine
Intervention description: Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168); Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28-day 84)
Intervention MeSH terms: Mitomycins; Mitomycin; Doxifluridine; Floxuridine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 855.0
Sex: All
Minimum age: 18 Years
Maximum age: 69 Years
Healthy volunteers: No
Keywords: Stomach cancer; Adjuvant chemotherapy; Mitomycin; Cisplatin; Doxifluridine

Summary:

      This is a phase III randomized study designed to evaluate the efficacy of mitomycin,
      doxifluridine, and cisplatin compared to mitomycin and doxifluridine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically proven gastric adenocarcinoma

          -  Curative resection was done

          -  stage II, IIIA, IIIB, IV (including T4, lesions or N3, but excluding M1 lymph node
             metastasis)

          -  age: 18-69 years old

          -  Performance status: ECOG 0-2

          -  Adequate bone marrow function (WBC ≥ 4,000/ul, platelet count ≥ 100,000/ul, hemoglobin
             ≥ 10 g/dl)

          -  Adequate renal function (serum creatinine≤ 1.5)

          -  Adequate liver function (serum bilirubin ≤1.5 mg/dl, AST/ALT ≤ 3 x normal upper limit)

          -  Written informed consent was signed by the patient

        Exclusion Criteria:

          -  Previous chemotherapy or radiotherapy

          -  Active ongoing infection which antibiotic treatment is needed

          -  Pregnant or lactating women

          -  Psychosis or convulsion disorder

          -  Ascites in preoperative abdomen CT

          -  Systemic disease which interfere the administration of chemotherapy

          -  Previous history of other malignancy except cured non-malignant skin cancer and
             uterine cervical cancer in situ
A Multi-Center Study Evaluating the Onset and Duration of Action of AC-170 0.24% Compared to Vehicle in the Conjunctival Allergen Challenge (CAC)
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: AC-170 0.24%; AC-170 0%
Intervention description: 1 drop in each eye at 2 separate times during a 14 day period; 1 drop in each eye at 2 separate times during a 14 day period
Intervention MeSH terms: Cetirizine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 91.0
Sex: All
Minimum age: 10 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the onset and duration of action of AC-170 0.24%
      compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in
      the conjunctival allergen challenge (CAC) model.
    

Eligibility criteria:

        Inclusion Criteria:

          -  positive bilateral conjunctival allergen challenge (CAC) reaction

        Exclusion Criteria:

          -  known contraindications or sensitivities to the study medication or its components

          -  any ocular condition that, in the opinion of the investigator, could affect the
             subjects safety or trial parameters

          -  use of disallowed medication during the period indicated prior to the enrollment or
             during the study
Evaluation of Xiaflex: Trial of Effectivenss iN Dupuytren's
Condition: Dupuytren's Disease
MeSH terms: Dupuytren Contracture
Intervention: collagenase injection; limited palmar fasciectomy
Intervention description: injection; surgery
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a prospective, multi-centre, pragmatic randomized controlled trial to compare both
      the clinical effectiveness and cost-effectiveness of collagenase injections (CI) versus
      limited palmar fasciectomy (LPF) to determine if collagenase is a superior treatment in terms
      of improved quality of life and reducing recurrence of the disease without serious
      complications. Since collagenase injections are costly it is also important to know if this
      novel intervention is cost-effective from the patient, Ministry of Health and societal
      perspectives.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Canadian Citizen

          2. 18 years of age or older

          3. Dupuytren's contracture of the metacarpophalangeal (MCP) joint or of the proximal
             interphalangeal (PIP) joint with a fixed flexion contracture of 20º or greater in at
             least 1 finger (not the thumb)

          4. Demonstrated inability to simultaneously place the affected finger and palm flat on a
             table

          5. Able to understand and communicate in English

        Exclusion Criteria:

          1. Previous treatment of the primary joint within 90 days of study inclusion

          2. Patients undergoing any concomitant procedure on the same hand (e.g. carpal tunnel
             release, stenosing tenosynovitis release)

          3. Persistent extension deficit from a previous surgery of the same digit

          4. Any chronic muscular or neuromuscular disorder affecting wrist or hand

          5. Patient generally unfit for surgery

          6. Patient with specific treatment preference

          7. Bleeding disorder or recent stroke

          8. Allergy to collagenase

          9. Collagenase treatment or treatment with any investigational drug within 30 days of
             study inclusion

         10. Use of a tetracycline derivative within 14 days of first dose of study drug (because
             tetracycline derivatives may inhibit the collagenolytic activity of mammalian
             collagenase homologs [i.e., matrix metalloproteinases])

         11. Pregnant or breast feeding patients

         12. Patients who do not have insurance coverage for collagenase injections

         13. Patients who are unable to provide informed consent or are unable to complete quality
             of life questionnaires due to mental capacity or neuro-psychological problems.
Gemcitabine/Irinotecan/ZD1839 vs Paclitaxel/Carboplatin/Etoposide/ZD1839 in Carcinoma of Unknown Primary Site
Condition: Neoplasms, Unknown Primary
MeSH terms: Neoplasms, Unknown Primary
Intervention: Etoposide; Gemcitabine; Irinotecan; Paclitaxel; Carboplatin
Intervention description: 50 mg alternating with 100 mg PO, days 1 and 10 in regimen A; 1000 mg/m2 IV, days 1 and 8, in regimen B; 1000 mg/m2 IV days 1 and 8 in regimen B; 200 mg/m2 by 1-hour IV infusion, day 1, regimen A; Area under the curve (AUC) 6.0 IV, day 1, regimen A
Intervention MeSH terms: Paclitaxel; Etoposide; Carboplatin; Gemcitabine; Irinotecan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 198.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Neoplasms, Unknown Primary

Summary:

      In this randomized trial, we will investigate the activity and toxicity of two active
      regimens, gemcitabine/irinotecan and paclitaxel/carboplatin/Etoposide (both followed by
      ZD1839) in the first-line treatment of patients with carcinoma of unknown primary site.
    

Eligibility criteria:

        Inclusion Criteria:

        To be included in this study, you must meet the following criteria:

          -  Carcinoma of unknown primary site

          -  Biopsy-proven metastatic carcinoma

          -  Able to perform activities of daily living with minimal assistance

          -  No previous treatment with any systemic therapy

          -  Measurable or evaluable disease

          -  Adequate bone marrow, liver and kidney function

          -  Understand the nature of this study and give written informed consent

        Exclusion Criteria:

        You cannot participate in this study if any of the following apply to you:

          -  Age < 18 years

          -  Uncontrolled brain metastases and meningeal involvement

          -  Other uncontrolled malignancies

          -  Women pregnant or lactating

          -  Recent history of significant cardiovascular disease

          -  Severe or uncontrolled systemic disease

          -  Other significant clinical disorder

          -  Clinically active interstitial lung disease

        Please note: There are additional inclusion/exclusion criteria. The study center will
        determine if you meet all of the criteria. If you do not qualify for the trial, study
        personnel will explain the reasons. If you do qualify, study personnel will explain the
        trial in detail and answer any questions you may have.