bioihbjkbjnl/mcl2 huggingface dataset:
Study of Subcutaneous Immunoglobulin in Patients With PID Requiring IgG Replacement Therapy
Condition: Primary Immune Deficiency
MeSH terms: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes
Intervention: Human Normal Immunoglobulin for Subcutaneous Administration
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 2 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Immune globulin subcutaneous; SCIG; Primary immunodeficiency; PID

Summary:

      The objective of this study is to assess the efficacy, tolerability, safety and
      pharmacokinetics of IgPro20 in patients with primary humoral immunodeficiency (PID).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female aged 2 to 75 years

          -  Subjects with primary humoral immunodeficiency, namely with a diagnosis of: CVID
             (Common Variable Immunodeficiency) as defined by PAGID (Pan-American Group for
             Immunodeficiency) and ESID (European Society for Immunodeficiencies) or XLA (X-linked
             Agammaglobulinemia)

          -  Written informed consent

        Exclusion Criteria:

          -  Newly diagnosed PID

          -  Evidence of an active serious infection at the time of screening (i.e., but not
             limited to: bacteremia/septicemia, pneumonia, fungal osteomyelitis)

          -  Malignancies of lymphoid cells such as lymphocytic leukemia, Non-Hodgkin's lymphoma
             and immunodeficiency with thymoma

          -  Known hyperprolinemia

          -  Hypoalbuminemia, protein-losing enteropathies, and any proteinuria

          -  Allergic reactions to immunoglobulins or other blood products

          -  Known antibodies to Immunoglobulin A (IgA)

          -  The subject is receiving steroids (oral and parenteral, daily ≥ 0.15 mg of prednisone
             equivalent/kg/day) or other systemic immunosuppressants

          -  Female who is pregnant, breast feeding or planning a pregnancy during the course of
             the study

          -  Participation in a study with an investigational product other than (IVIG) within 1
             month prior to enrollment

          -  A positive result at screening on any of the following viral markers: Human
             Immunodeficiency Virus (HIV), Hepatitis C virus (HCV) and Hepatitis B virus (HBV)

          -  Aspartate aminotransferase (ASAT) or Alanine aminotransferase (ALAT) concentration >
             2.5 times the upper normal limit (UNL)

          -  Creatinine concentration > 1.5 times the UNL

          -  Any condition that is likely to interfere with evaluation of the study drug or
             satisfactory conduct of the trial
A Study of the Efficacy and Safety of Re-treatments With Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-tnfa Therapies
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: methotrexate; rituximab [MabThera/Rituxan]
Intervention description: a 10-25 mg stable dose given orally or parenterally throughout study; 1 g given by intravenous infusion on Days 1 and 15 of each treatment course
Intervention MeSH terms: Rituximab; Methotrexate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 341.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study will assess the long-term safety and efficacy of repeating treatment with
      MabThera, in combination with methotrexate and steroids, in patients who were previously
      randomized into MabThera study WA17042. The anticipated time on study treatment is until
      Mabthera is available on the local market and the target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients 18-80 years of age with active RA;

          -  patients who participated in MabThera study WA17042, and completed to at least the
             Week 24 visit;

          -  eligible for re-treatment, based on clinical symptoms;

          -  patients of reproductive potential must be using reliable contraceptive methods.

        Exclusion Criteria:

          -  patients who participated in MabThera study WA17042 but withdrew into the safety
             follow-up;

          -  current treatment with any other disease-modifying antirheumatic drug (apart from
             methotrexate), or any anti-TNFalfa, anti-IL1, or other biologic therapies;

          -  development of any new contraindications to receiving MabThera;

          -  women who are pregnant or breast-feeding.
A Study of Mirvetuximab Soravtansine vs. Investigator's Choice of Chemotherapy in Women With Folate Receptor (FR) Alpha Positive Advanced Epithelial Ovarian Cancer (EOC), Primary Peritoneal or Fallopian Tube Cancer
Condition: Epithelial Ovarian Cancer; Primary Peritoneal Carcinoma; Fallopian Tube Cancer; Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms
Intervention: Mirvetuximab soravtansine; Paclitaxel; Pegylated liposomal doxorubicin; Topotecan
Intervention description: Mirvetuximab Soravtansine will be administered per dose and schedule specified in the arm.; Paclitaxel will be administered per dose and schedule specified in the arm.; Pegylated liposomal doxorubicin will be administered per dose and schedule specified in the arm.; Topotecan will be administered per dose and schedule specified in the arm.
Intervention MeSH terms: Paclitaxel; Maytansine; Doxorubicin; Liposomal doxorubicin; Topotecan; Mirvetuximab soravtansine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 366.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Epithelial ovarian cancer; Fallopian tube cancer; Primary peritoneal cancer; IMGN853; ADC; Antibody drug conjugate; ImmunoGen; Antibody; Folate receptor alpha; mirvetuximab soravtansine; Phase 3; platinum-resistant; MIRV

Summary:

      This is a Phase 3, open label, randomized study designed to compare the safety and efficacy
      of mirvetuximab soravtansine to that of selected single-agent chemotherapy (Investigator's
      choice) in women with platinum-resistant FR-alpha positive advanced EOC, primary peritoneal
      cancer and/or fallopian tube cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must be diagnosed with advanced epithelial ovarian cancer, primary
             peritoneal cancer or fallopian tube cancer

          -  Participants must have folate receptor alpha positive tumor expression as defined in
             the protocol

          -  Participants must have platinum-resistant ovarian cancer, defined as progression
             within 6 months from completion of a minimum of four cycles of platinum-containing
             therapy.

          -  Participants must have received at least one but no more than three prior systemic
             treatment regimens and for whom single-agent chemotherapy is appropriate as the next
             line of treatment

          -  Participants must have at least one lesion that meets the definition of measurable
             disease by RECIST 1.1

        Exclusion Criteria:

          -  Diagnosis of clear cell, low grade ovarian cancer or mixed tumors

          -  Participants with primary platinum-refractory disease

          -  Serious concurrent illness or clinically relevant active infection as defined in the
             protocol

          -  Prior treatment with mirvetuximab soravtansine

          -  Women who are pregnant or breast feeding
Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic HCV Infection
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Hepatitis C; Hepatitis
Intervention: SOF/VEL; Placebo
Intervention description: 400/100 mg FDC tablet administered orally once daily; Tablet administered orally once daily
Intervention MeSH terms: Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 741.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Sofosbuvir; SOF/VEL; Velpatasvir; Hepatitis C; HCV; cirrhosis

Summary:

      The primary objectives of this study are to evaluate the efficacy, safety, and tolerability
      of sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) for 12 weeks in adults with
      chronic genotype 1, 2, 4, 5, or 6 hepatitis C virus (HCV) infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing and able to provide written informed consent

          -  HCV RNA ≥ 10^4 IU/mL at screening

          -  HCV genotype 1, 2, 4, 5, 6, or indeterminate assessed at screening by the central
             laboratory

          -  Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy

          -  Classification as treatment naive or treatment experienced

          -  Males and females of childbearing potential who engage in heterosexual intercourse
             must agree to use protocol specified method(s) of contraception

        Exclusion Criteria:

          -  Current or prior history of clinically-significant illness (other than HCV) or any
             other major medical disorder that may interfere with treatment, assessment, or
             compliance with the protocol; individuals currently under evaluation for a potentially
             clinically-significant illness (other than HCV) are also excluded.

          -  Screening ECG with clinically significant abnormalities

          -  Laboratory results outside of acceptable ranges at Screening

          -  Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A
             inhibitor

          -  Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
Duloxetine for Multiple Sclerosis Pain
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Duloxetine Hydrochloride (HCI); Placebo
Intervention description: Participants received 30 mg duloxetine (po, QD) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period. If the participant completes the double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).; Participants received placebo oral (po), once daily (QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 milligrams [mg] QD for 12 weeks).
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 239.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Central Neuropathic Pain; Multiple Sclerosis

Summary:

      This study is designed to primarily assess the efficacy and safety of duloxetine 60-120 mg
      once daily (QD) compared with placebo on the reduction of pain severity in participants with
      central neuropathic pain due to Multiple Sclerosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have central neuropathic pain due to multiple sclerosis (MS) based on the disease
             diagnostic criteria

          -  Adult males or females

          -  Have a score of 4 or greater on the daily 24-hour average pain score

          -  Females must test negative for pregnancy at study entry

          -  Complete the daily diaries for at least 70% of the days of the study

          -  Participants may continue other prescription and nonprescription analgesic pain
             medications as long as the dose has been stable for 1 month prior to study entry, and
             they agree to maintain that stable dose throughout the study Disease Diagnostic
             Criteria:

               -  Diagnosis of MS at least 1 year prior to study entry

               -  No MS flares or change in disease treatment for the 3 months prior to study entry

               -  Daily pain due to MS for a minimum of 3 months prior to study entry

        Exclusion Criteria:

          -  Are currently in a clinical trial of MS disease-modifying therapy

          -  Have pain that cannot be clearly differentiated from causes other than MS

          -  Any current or historical diagnosis of mania, bipolar disorder, psychosis, or
             schizoaffective disorder

          -  History of substance abuse or dependence

          -  Are pregnant or breast-feeding
Study of Subcutaneous Golimumab in Chinese Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Golimumab; Placebo; Methotrexate (MTX)
Intervention description: 50 mg subcutaneous (SC) injection every 4 weeks for up to 48 weeks; Placebo SC injections at Weeks 0, 4, 8, 12, 16, and Week 20 followed by golimumab 50 mg SC injections at Week 24 and every 4 weeks thereafter up to Week 48.; A stable dose of MTX (oral or injectable) will be administered to participants according to the local prescribing guidelines for up to 48 weeks.
Intervention MeSH terms: Golimumab; Methotrexate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 264.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis; injection; golimumab; simponi

Summary:

      The purpose of this study is to evaluate the safety and efficacy of golimumab in Chinese
      patients with rheumatoid arthritis.
    

Eligibility criteria:

        Inclusion Criteria:

        - Diagnosis of rheumatoid arthritis for at least 6 months

          -  Be on a stable dose of methotrexate for 4 weeks

          -  Have at least 4 swollen and 4 tender joints

        Exclusion Criteria:

          -  Prior exposure to biologic anti-TNFalpha agents

          -  Inflammatory diseases other than rheumatoid arthritis

          -  Treatment with Disease Modifying Anti-rheumatic drug (DMARDs)/systemic
             immunosuppressives other than methotrexate during the 4 weeks prior to the first
             administration of study agent

          -  History of, or ongoing, chronic or recurrent infectious disease
A Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: CC-5013 plus dexamethasone; Dexamethasone plus Placebo
Intervention description: 25 mg daily for 21 days every 28 days.; Oral pulse dexamethasone is administered at a dose of 40mg daily on Days 1-4, 9-12, and 17-20 of each 28 day cycle for Cycles 1 through 4. Beginning with Cycle 5, the oral dexamethasone dosing schedule will be reduced to 40mg daily for Days 1-4 every 28 days. In addition, oral placebo capsules will be administered for 28 days of every cycle.
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Lenalidomide; BB 1101
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 351.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multiple Myeloma; Celgene; Revlimid; CC-5013

Summary:

      To compare the efficacy of oral CC-5013 in combination with oral pulse high-dose
      dexamethasone to that of placebo and oral high-dose pulse dexamethasone as treatment for
      subjects with relapsed or refractory multiple myeloma."
    

Eligibility criteria:

        Inclusion Criteria:

          -  Prior or current diagnosis Durie-Salmon stage II or III multiple myeloma.

          -  Measurable levels of myeloma paraprotein in serum or urine (24-hour collection
             sample).

          -  Eastern Cooperative Oncology Group (ECOG) performance status score of 0,1, or 2

          -  Females of childbearing potential must have a negative serum or urine pregnancy test
             within 7 days of starting study drug

        Exclusion Criteria:

          -  Prior development of disease progression during high-dose dexamethasone containing
             therapy

          -  Pregnant or lactating females

          -  The development of a desquamating rash while taking thalidomide

          -  Use of any standard/experimental anti-myeloma therapy within 28 days of randomization
             or use of any experimental non-drug therapy within 56 days of initiation of drug
             treatment

          -  Laboratory abnormalities: Absolute neutrophil count less than 1,000 cells/mm3

          -  Laboratory abnormalities: Platelet count < 75,000/mm3

          -  Laboratory abnormalities: Serum creatinine > 2.5 mg/dL

          -  Laboratory abnormalities: Serum Serum glutamic oxaloacetic transaminase
             (SGOT)/Aspartate aminotransferase (AST) or Serum glutamic pyruvic transaminase
             (SGPT)/Alanine aminotransferase (ALT) > 3.0 x upper limit of normal

          -  Laboratory abnormalities: Serum total bilirubin > 2.0 mg/dL

          -  Prior history of malignancies other than multiple myeloma unless the subject has been
             free of the disease for ≥ 3 years.
Follow-up Study for Patients Who Completed Study ALX0681-C301 (Post-HERCULES)
Condition: Acquired Thrombotic Thrombocytopenic Purpura
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombotic Thrombocytopenic
Intervention: Caplacizumab; Standard of Care
Intervention description: • PE with plasma (e.g., fresh frozen plasma, solvent detergent/viral-inactivated plasma, cryosupernatant), • Corticosteroid treatment and • Use of other immunosuppressive agents (e.g., rituximab).
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 104.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objectives of this study were to evaluate long-term safety and efficacy of caplacizumab,
      to evaluate safety and efficacy of repeated use of caplacizumab and to characterize long-term
      impact of acquired thrombotic thrombocytopenic purpura (aTTP).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Completed the Final (28 day) follow-up visit in Study ALX0681-C301.

          2. >= 18 years of age at the time of signing the informed consent form.

          3. Provided informed consent prior to initiation of any study specific
             activity/procedure.

        Exclusion Criteria:

          1. Not being able/willing to comply with the study protocol procedures.

          2. Currently enrolled in a clinical study with another investigational drug or device.
Celebrex In Acute Gouty Arthritis Study
Condition: Arthritis, Gouty
MeSH terms: Arthritis; Arthritis, Gouty
Intervention: Indomethacin; Celecoxib; Celecoxib; Celecoxib
Intervention description: indomethacin 50 mg three times a day (TID) for 8 days.; An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg two times a day (BID) for 7 days.; An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later (celecoxib 400/200 mg regimen) and continuing 200 mg two times a day (BID) for 7 days.; Celecoxib 50 mg two times a day (BID) for 8 days
Intervention MeSH terms: Celecoxib; Indomethacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 402.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a multicenter, double-blind, double-dummy, randomized, active-controlled study that
      will include an 8-day treatment period followed by a 1-week follow-up period in patients
      experiencing symptoms of an acute exacerbation of gouty arthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Acute gouty arthritis meeting the American College of Rheumatology (ACR) criteria for
             acute arthritis of primary gout;

          -  Onset of pain from an acute gouty arthritis attack within 48 hours prior to
             Screening/Baseline (Visit 1);

          -  A rating of moderate, severe, or extreme (2, 3, or 4, respectively) on the Patient's
             assessment of pain intensity in the index joint (5-point scale:0-4) at
             Screening/Baseline.

        Exclusion Criteria:

          -  Diagnosis of any other type of arthritis including those types suspected of being
             infectious in origin in the index joint or presence of any acute trauma of the index
             joint. Patients with osteoarthritis will be included as long as it is mild or moderate
             (according to investigator's criteria) and it does not affect the index joint;

          -  Acute polyarticular gout involving greater than 4 joints or chronic gout.