bioihbjkbjnl/mcl2 huggingface dataset:
Phase III Study of Two Different Schedules (Weekly and Tri-weekly) of Combination of Gemcitabine and Two Taxanes in MBC
Condition: Metastatic Breast Cancer (MBC)
MeSH terms: Breast Neoplasms
Intervention: Gemcitabine; Docetaxel; Paclitaxel
Intervention description: Arm A: 1000 mg/m², 30 minute (min) intravenous (IV) infusion on Days 1 and 8, repeated every 21 days for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions).
Arm B: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Arm C: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Arm D: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.; Arm A: 75 milligram per square meter (mg/m²), 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Arm C: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15, to be given 30 min prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.; Arm B: 175 mg/m², IV infusion over approximately 3 hours, followed by Gemcitabine, on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Arm D: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.
Intervention MeSH terms: Paclitaxel; Docetaxel; Gemcitabine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Enrollment: 241.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Multi-center, randomized Phase III study. 4 arms. 360 Patient to enroll. Purpose is evaluate
      time to progression disease (PD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic diagnosis of metastatic breast cancer (MBC).

          -  Prior neoadjuvant or adjuvant taxanes regimen is allowed if ≥12 months since
             completion of the regimen.

          -  Relapsing after receiving one adjuvant/neoadjuvant chemotherapy containing an
             anthracycline if not clinically contraindicated.

          -  Patients with measurable disease.

          -  Previous hormonal therapy for adjuvant setting or metastatic disease.

        Exclusion Criteria:

          -  Previous chemotherapy for MBC

          -  Previous chemotherapy with gemcitabine in any setting of disease

          -  Patient candidable to treatment with trastuzumab.
A Study of Adalimumab in Japanese Subjects With Intestinal Behçet's Disease
Condition: Intestinal Behçet's Disease
MeSH terms: Behcet Syndrome
Intervention: Adalimumab
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 15 Years
Healthy volunteers: No
Keywords: Behçet's, intestinal

Summary:

      To investigate efficacy, safety and pharmacokinetics of adalimumab subcutaneous (sc) for
      Japanese subjects with intestinal Behçet's disease who are refractory to conventional
      therapies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Intestinal Behçet's disease

          -  Patients with typical ulcer at ileocecal region

          -  Patients who have failed conventional treatment

        Exclusion Criteria:

          -  Crohn's disease

          -  History of ileocecal resection

          -  History of tuberculosis (TB)

          -  Female subject who is pregnant or breast-feeding or considering becoming pregnant
             during the study
Extension Trial of the Long Term Safety of BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Intervention: Nintedanib
Intervention description: Nintedanib twice a day
Intervention MeSH terms: Nintedanib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 752.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The aim of this extension trial is to assess the long-term safety of BIBF 1120 treatment in
      patients with Idiopathic Pulmonary Fibrosis who have completed one year treatment and the
      follow up period in the double-blind phase III placebo controlled parent trials (1199.32 and
      1199.34), who wish to continue treatment with BIBF 1120.
    

Eligibility criteria:

        Inclusion criteria:

          1. Signed Informed Consent consistent with International Conference on Harmonisation-Good
             Clinical Practices (ICH-GCP) and local laws prior to trial participation.

          2. Patients from trials 1199.32 or 1199.34 who completed the 52 weeks treatment period
             and performed the follow-up visit.

        Exclusion criteria:

          1. Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) > 1.5 fold Upper
             Limit of Normal (ULN) (Patients who completed the parent trial with transaminase
             values > 1.5 fold ULN but < 3 fold ULN are considered eligible)

          2. Bilirubin > 1.5 fold ULN

          3. Bleeding risk

          4. Planned major surgery within the next 3 months, including lung transplantation, major
             abdominal or major intestinal surgery.

          5. New major thrombo-embolic events developed after completion of the parent trial.

          6. Time period > 12 weeks between Visit 9 of the parent trial and Visit 2 of this study.

          7. Usage of any investigational drug after completion of the parent trial or planned
             usage of a specific investigational drug during the course of this trial.

          8. A disease or condition which in the opinion of investigator may put the patient at
             risk because of participation in this trial or limit the patients' ability to
             participate in this trial.

          9. Alcohol or drug abuse which in the opinion of the investigator would interfere with
             trial participation.

         10. Pregnant women or women who are breast feeding or of child bearing potential not using
             two effective methods of birth control (one barrier and one highly effective
             non-barrier) for at least 1 month prior to Visit 2 and/or not committing to using it
             until 3 months after end of treatment.
APOLLO: The Study of an Investigational Drug, Patisiran (ALN-TTR02), for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis
Condition: TTR-mediated Amyloidosis; Amyloidosis, Hereditary; Amyloid Neuropathies, Familial; Familial Amyloid Polyneuropathies; Amyloid Neuropathies; Amyloidosis, Hereditary, Transthyretin-Related
MeSH terms: Polyneuropathies; Amyloid Neuropathies; Amyloid Neuropathies, Familial; Amyloidosis, Familial; Amyloidosis
Intervention: patisiran (ALN-TTR02); Sterile Normal Saline (0.9% NaCl)
Intervention description: administered by intravenous (IV) infusion; administered by intravenous (IV) infusion
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 225.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: RNAi therapeutic; FAP; Familial Amyloid Polyneuropathy; TTR; Transthyretin; Amyloidosis

Summary:

      The purpose of this study is to evaluate the safety and efficacy of patisiran (ALN-TTR02) in
      patients with transthyretin (TTR) mediated amyloidosis. An open-label, single-arm, long-term
      follow-up extension study NCT02510261 (ALN-TTR02-006) was initiated to provide participants
      who completed this study with continued patisiran-LNP (lipid nanoparticle) treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female of 18 to 85 years of age (inclusive);

          -  Have a diagnosis of FAP

          -  Neuropathy Impairment Score requirement of 5-130

          -  Meet Karnofsky performance status requirements

          -  Have adequate complete blood counts and liver function tests

          -  Have adequate cardiac function

          -  Have negative serology for hepatitis B virus (HBV) and hepatitis C virus (HCV)

        Exclusion Criteria:

          -  Had a prior liver transplant or is planned to undergo liver transplant during the
             study period;

          -  Has untreated hypo- or hyperthyroidism;

          -  Has known human immunodeficiency virus (HIV) infection;

          -  Had a malignancy within 2 years, except for basal or squamous cell carcinoma of the
             skin or carcinoma in situ of the cervix that has been successfully treated;

          -  Recently received an investigational agent or device

          -  Is currently taking diflunisal, tafamidis, doxycycline, or tauroursodeoxycholic acid
Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Migraine Prevention
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Erenumab; Placebo
Intervention description: Administered by subcutaneous injection once a month; Administered by subcutaneous injection once a month
Intervention MeSH terms: Erenumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 955.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Migraine; Headache; Prevention; Prophylaxis

Summary:

      The primary objective of the study was to evaluate the effect of erenumab compared to placebo
      on the change from baseline in monthly migraine days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of migraine (with or without aura) for ≥ 12 months prior to screening
             according to the International Headache Society (IHS) International Classification of
             Headache Disorders (ICHD-3) classification

          -  Migraine frequency: ≥ 4 and < 15 migraine days per month on average across the 3
             months prior to screening and during baseline

          -  Headache frequency: < 15 headache days per month on average across the 3 months prior
             to screening and baseline

          -  Demonstrated at least 80% compliance with the eDiary.

        Exclusion Criteria:

          -  Older than 50 years of age at migraine onset

          -  History of cluster headache or hemiplegic migraine headache

          -  Unable to differentiate migraine from other headache

          -  No therapeutic response with > 2 medication categories for prophylactic treatment of
             migraine after an adequate therapeutic trial

          -  Used a prohibited medication, device, or procedure within 2 months prior to the start
             of the baseline phase or during the baseline phase

          -  Concomitant use of 2 or more medications with possible migraine prophylactic effects
             within 2 months prior to the start of the baseline phase or during the baseline phase.
             If only 1 prophylactic medication is used, the dose must be stable within 2 months
             prior to the start of the baseline phase and throughout the study
Study to Evaluate the Immunogenicity, Safety, and Tolerability of a Tick-Borne Encephalitis (TBE) Vaccine in Healthy Japanese Participants 1 Year of Age and Older
Condition: Tick-Borne Encephalitis
MeSH terms: Encephalitis, Tick-Borne; Encephalitis
Intervention: TBE vaccine 0.5 mL; TBE vaccine 0.25 mL
Intervention description: TBE vaccine 0.5 mL (intramuscular injection).; TBE vaccine 0.25 mL (intramuscular injection).
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 165.0
Sex: All
Minimum age: 1 Year
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purpose of this study is to provide safety and immunogenicity data in Japanese
      participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese male or female participants ≥1 years old at Visit 1.

          -  Participants and/or a legally acceptable representative/parent/legal guardian are
             willing and able to comply with all scheduled visits, vaccination plan, and other
             study procedures including completion of the e-diary for 7 days for participants after
             each of 3 vaccinations.

          -  Participants and/or a legally acceptable representative/parent/legal guardian must be
             able to be contacted by telephone during study participation.

          -  Participants and/or a legally acceptable representative/parent/legal guardian are
             capable of giving signed informed consent.

        Exclusion Criteria:

          -  Major known congenital malformation or serious chronic disorder.

          -  Known history of TBEV infection.

          -  Known history of other flavivirus infection (eg, dengue fever, yellow fever, JEV, West
             Nile virus).

          -  Known history of infection with HIV, HCV, or HBV.

          -  Immunocompromised participants with known or suspected immunodeficiency.

          -  History of autoimmune disease or an active autoimmune disease requiring therapeutic
             intervention.

          -  Previous vaccination with any licensed or investigational TBE vaccine, or planned
             receipt of other flavivirus vaccines apart from JEV vaccine (eg, yellow fever, dengue
             fever) during the study. Administration of JEV vaccine is prohibited during
             participation.
Lucentis as an Adjuvant Therapy With TTT-ICG Based in Choroidal Melanoma
Condition: Choroidal Melanoma
MeSH terms: Melanoma
Intervention: Ranibizumab injection and TTT - ICG based
Intervention description: Intravitreal injection of ranibizumab (0.5mg) once a month for 6 months and transpupillary thermotherapy enhanced with Indocyanine Green (ICG) dye, once or twice starting at 2nd month.
Intervention MeSH terms: Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Choroidal melanoma; Lucentis; TTT-ICG

Summary:

      To report preliminary results on safety and tolerability of intravitreal injection of
      Ranibizumab (Lucentis) combined with Transpupillary Thermotherapy (TTT)+ Indocyanine Green
      (ICG)-based photodynamic therapy (PDT) in the treatment of choroidal melanoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 18 yo.

          -  Primary pigmented or amelanotic choroidal melanoma measurement of 16 mm or less in the
             largest vessel diameter and 6 mm or less in the apical height.

          -  Location of the tumor posterior to the equator.

          -  Documented growth by A/B scan.

          -  Risk factor for metastasis (thickness greater than 2 mm, symptoms, tumor margin at the
             optic disc)

          -  Ability to provide inform consent.

          -  Comply with the study assessment for the cooperation of the study.

        Exclusion Criteria:

          -  Pregnancy or lactation.

          -  Premenopausal women not using adequate contraception; surgical sterilization or use of
             oral contraception, barrier contraception with either a condom or diaphragm or in
             conjunction with spermicidal gel, an IUD or contraceptive hormon implant or patch.

          -  Current infection or inflammation in either eye.

          -  Extension of tumor into the orbit.

          -  Retinal spread or metastatic disease.

          -  Any other condition that the investigator believes would pose a significant hazard to
             the subject if the investigational therapy were initiated.

          -  Any known allergy to any of the components to be used in the study.

          -  Participation in another simultaneous medical investigation or trial.
Strategies to Reduce Injuries and Develop Confidence in Elders
Condition: Accidental Falls; Wounds and Injuries
MeSH terms: Wounds and Injuries
Intervention: Evidence-based tailored fall prevention; Usual care
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 5451.0
Sex: All
Minimum age: 70 Years
Healthy volunteers: No

Summary:

      The aim of this pragmatic cluster-randomized trial is to determine the effectiveness of an
      evidence-based, patient-centered multifactorial fall injury prevention strategy in community
      dwelling older adults at risk of falls recruited from 86 primary care practices around the
      U.S.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient is at least 70 years of age.

          -  The patient must answer 'yes' to one or more of the following questions:

          -  Have you fallen and hurt yourself in the past year?

          -  Have you fallen 2 or more times in the past year?

          -  Are you afraid that you might fall because of balance or walking problems?

        Exclusion Criteria:

          -  The patient is enrolled in hospice.

          -  The patient resides in a nursing home.

          -  The patient is not capable of providing informed consent (or assent), and a proxy is
             not available.

          -  The patient does not speak English or Spanish
Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Eczema/Dermatitis and Dermal Pruritus (MK-4117-202)
Condition: Eczema; Dermatitis; Dermal Pruritus
MeSH terms: Dermatitis; Eczema; Pruritus
Intervention: Desloratadine 5 mg
Intervention description: Desloratadine 5 mg/day: one 5-mg tablet taken orally once daily in the evening for up to 12 weeks (Desloratadine 10 mg/day: two 5-mg tablets taken orally once daily in the evening for up to 8 weeks)
Intervention MeSH terms: Desloratadine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 94.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Dermatitis; Dermatitis, Atopic; Skin Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Summary:

      This is an efficacy and safety study of up to 12 weeks of desloratadine in Japanese
      participants with eczema/dermatitis and dermal pruritus. The primary hypothesis of this study
      is that the sum of the daytime and nighttime pruritus/itch scores for both the
      eczema/dermatitis group and the dermal pruritus group will be significantly improved at Week
      2 compared to Baseline.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eczema/dermatitis (acute eczema, chronic eczema, contact dermatitis, atopic
             dermatitis, nummular eczema, seborrheic dermatitis, asteatotic eczema,
             neurodermatitis, etc. among eczema/dermatitis for which the observation of pruritus is
             appropriate)

          -  Dermal pruritus (generalized dermal pruritus, localized dermal pruritus)

        Exclusion Criteria:

          -  Hypersensitivity to antihistamines or ingredients of a study drug
A Study of CellCept (Mycophenolate Mofetil) in Combination Therapy in Heart Transplant Patients.
Condition: Heart Transplantation
Intervention: mycophenolate mofetil (MMF); cyclosporine A (CsA); corticosteroids
Intervention description: 1.0 g PO BID; Initial loading dose of 4 to 6 mg/kg within 48 hours of transplantation, adjusted thereafter to a blood trough concentration of 150 to 300 ng/mL; As per the practice of each participating center
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Cyclosporins
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will investigate the efficacy and safety of CellCept (1.5-2g/day po), in
      combination with a standard care regimen of cyclosporine A (trough level 150-200ng/mL) and
      steroids, in patients receiving a heart transplant. The anticipated time on study treatment
      is 24 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  patients receiving their first heart transplant (single organ transplant).

        Exclusion Criteria:

          -  patients with a positive donor-specific cross-match at the time of transplantation;

          -  patients with any antibody-treated acute rejection;

          -  known contraindications to treatment with sirolimus;

          -  history of malignancy, other than excised non-melanoma skin cancer which has not
             recurred for 2 years.