bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 1/2, Randomized, Placebo-controlled, Observer-blinded Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine In Healthy Adults 18 To 49 Years Of Age
Condition: Group B Streptococcal Infections
MeSH terms: Streptococcal Infections
Intervention: Multivalent group B streptococcus vaccine; Placebo
Intervention description: Various formulations at three dose levels; Saline Control
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 365.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is the Phase 1/2 first-in-human, randomized, placebo-controlled, observer-blinded study
      evaluating the investigational multivalent group B streptococcus vaccine. Healthy adults aged
      18 to 49 years of age with no history of group B streptococcal vaccination will be randomized
      to receive either a single intramuscular dose of multivalent group B streptococcus vaccine
      (various formulations at 3 dose levels) or a placebo (saline control).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy adults (male and female) 18 to 49 years of age at enrollment who are
             determined by medical history, physical examination, and clinical judgment of the
             investigator to be eligible for inclusion in the study.

          2. Negative urine pregnancy test at Visit 1 for all female subjects who are of
             childbearing potential.

        Exclusion Criteria:

          1. Male subjects and female subjects of childbearing potential who are unwilling or
             unable to use a highly effective method of contraception as outlined in this protocol
             for at least 3 months after the last dose of investigational product.

          2. Acute or chronic medical or psychiatric condition or laboratory abnormality that may
             increase the risk associated with study participation or investigational product
             administration or may interfere with the interpretation of study results and, in the
             judgment of the investigator, would make the subject inappropriate for entry into this
             study. Chronic medical conditions include human immunodeficiency virus, chronic
             hepatitis B virus (HBV) infection (HBV surface antigen positive), and/or hepatitis C
             virus infection.

          3. History of severe adverse reaction and/or severe allergic reaction (eg, anaphylaxis)
             to any vaccine.

          4. History of microbiologically proven invasive disease caused by group B streptococcus
             (Streptococcus agalactiae).

          5. Previous vaccination with any licensed or investigational group B streptococcus
             vaccine, or planned receipt during the subject's participation in the study (through
             the last blood draw).
A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Study 156-04-001]
Condition: Autosomal Dominant Polycystic Kidney Disease
MeSH terms: Arthrogryposis; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Intervention: OPC-41061
Intervention description: orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years.
Intervention MeSH terms: Tolvaptan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Healthy volunteers: No
Keywords: ADPKD; Tolvaptan

Summary:

      Investigation into the long-term safety and efficacy of OPC-41061 in repeated oral
      administrations at doses of 15 mg twice daily in patients with ADPKD who completed the
      preceding dose-finding study (156-04-001).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who completed 5-day repeated administrations and the follow-up observation in
             the preceding study (156-04-001)

          -  Patients in whom the safety of repeated administration was confirmed based on the
             investigator's reports from the preceding study (156-04-001)

        Exclusion Criteria:

          -  Patients with serum creatinine concentration of 2.5 mg/dL or higher at the screening
             examination

          -  Patients with any of the following complications

               -  Uncontrolled hypertension

               -  Serious cardiovascular disease (eg. heart failure) or hepatic disease (eg.
                  cirrhosis)"

          -  Patients with any of the following complications or history thereof

               -  Clinically significant drug allergies (anaphylaxis) or hypersensitivity
                  (especially, hypersensitivity to benzazepine derivatives or suspected
                  hypersensitivity thereto)

               -  Inability to personally give consent due to a mental disease "

          -  Patients with SBP (in sitting position) <90 mm Hg (at screening examination)

          -  Patients with history of massive bleeding or bleeding tendency

          -  Patients with a history of drug or alcohol abuse within 6 months prior to the
             screening examination

          -  Pregnant women, lactating women, or women who may become or plan to become pregnant

          -  Patients who received any investigational drug other than OPC-41061 within 30 days
             prior to commencement of administration of OPC-41061

          -  Any patient who, in the opinion of the principle investigator or attending
             investigators, should not participate in the study
POC-MD MRI-based Trial in Relapsing-remitting Multiple Scler
Condition: Relapsing-remitting Multiple Sclerosis; RRMS
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: AIN457; Placebo
Intervention description: infusion 10 mg/Kg; infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 73.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: relapsing-remitting multiple sclerosis; RRMS

Summary:

      A randomized, multi-center, double-blind, proof-of-concept study to assess the effect of
      multiple infusions of AIN457 (10 mg/kg) versus placebo on disease activity as measured by MRI
      scans over a 24 week period in patients with relapsing-remitting multiple sclerosis
    

Eligibility criteria:

        Inclusion Criteria:

        -

        Exclusion Criteria:

        -
Multiple Escalating Dose Study of BAY1093884 in Adults With Hemophilia A or B With or Without Inhibitors
Condition: Hemophilia A and B
MeSH terms: Hemophilia A
Intervention: Befovacimab (BAY1093884)
Intervention description: Once weekly doses until premature termination of the study, subcutaneous injection
Intervention MeSH terms: Lipoprotein-associated coagulation inhibitor; Immunoglobulins; Immunoglobulin G
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Subcutaneous; Prophylaxis; Non-Inhibitors; Inhibitors

Summary:

      The purpose of this study was to assess the safety and tolerability of multiple doses of a
      human monoclonal antibody (BAY1093884) given under the skin in subjects with hemophilia A or
      B. This antibody was intended to protect from bleeds by inhibiting a substance (Tissue Factor
      Pathway Inhibitor, TFPI) that reduces the ability of the body to form blood clots.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male severe hemophilic patients with undetectable FVIII activity <1% or FIX activity
             <2%, with or without inhibitors (any titer) are eligible.

          -  Subjects with a past history of inhibitors (any inhibitor titer) are eligible.

          -  Age ≥18 years.

          -  Documentation of ≥4 bleeding episodes (any type or location of bleeds, treated or not)
             within the 6 months prior to screening.

          -  For subjects on prophylaxis: Willingness to interrupt ongoing prophylaxis.

          -  For subjects on immune tolerance induction (ITI): Willingness to interrupt ongoing
             ITI.

        Exclusion Criteria:

          -  History of any other coagulation disorder (particularly disseminated intravascular
             coagulopathy or combined FVIII/FV deficiency) or platelet disorder.

          -  History of diseases related to venous thromboembolic events (e.g., pulmonary embolism,
             deep vein thrombosis, thrombophlebitis) or thrombotic microangiopathy.

          -  Risk factors for venous or arterial diseases (e.g., uncontrolled hypertension,
             uncontrolled diabetes).

          -  History of cardiac, coronary and/or arterial peripheral atherosclerotic disease

          -  Platelet count <100,000/μL.

          -  Human immunodeficiency virus (HIV) infection with a cluster of differentiation 4
             (CD4+) lymphocyte count of <200/mm^3
A Pilot Study of KRX-0502 (Ferric Citrate, Administered Without Food, in Treating Iron-deficiency Anemia
Condition: Anemia of Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Intervention: KRX-0502
Intervention description: 1g tablets of KRX-0502
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of the study is to evaluate the efficacy and safety of KRX-0502, administered
      without food, in treating iron deficiency anemia in subjects with stage 3 to 5 non-dialysis
      dependent chronic kidney disease (NDD-CKD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and non-lactating females with negative serum pregnancy test (for females of
             child-bearing potential) at Screening

          -  Age ≥ 18 years

          -  Serum ferritin ≤ 300 ng/mL and TSAT ≤ 25% at Screening

          -  Hemoglobin ≥9.0 g/dL and ≤11.5 g/dL at Screening

          -  eGFR <60 mL/min at Screening using the 4-variable Modification of Diet in Renal
             Disease (MDRD) equation

        Exclusion Criteria:

          -  Subjects receiving phosphate binder medication(s) at, or within 4 weeks prior to,
             screening

          -  Symptomatic gastrointestinal bleeding, inflammatory bowel disease, inflammatory bowel
             syndrome and/or Crohn's Disease within 24 weeks prior to \ Screening

          -  Evidence of acute kidney injury or requirement for dialysis within 8 weeks prior to
             Screening

          -  Kidney transplant anticipated or start of dialysis expected within 16 weeks of
             Screening

          -  History of hemochromatosis

          -  IV iron administered within 4 weeks prior to Screening

          -  Erythropoiesis-Stimulating Agent (ESA) administered within 4 weeks prior to Screening

          -  Blood transfusion within 4 weeks prior to Screening

          -  Receipt of any investigational drug within 4 weeks prior to Screening

          -  Cause of anemia other than iron deficiency or chronic kidney disease

          -  History of malignancy in the last five years

          -  Active drug or alcohol dependence or abuse (excluding tobacco use) within the 12
             months prior to Screening

          -  Any known allergies to iron products

          -  Previous intolerance to oral ferric citrate

          -  Psychiatric disorder that interferes with the subject's ability to comply with the
             study protocol

          -  Planned surgery or hospitalization during the trial

          -  Any other medical condition that, in the opinion of the PI, renders the subject unable
             to or unlikely to complete the trial or that would interfere with optimal
             participation in the trial or produce significant risk to the subject
A Study of the Safety and Efficacy of MK-0773 in Women With Sarcopenia (Loss of Muscle Mass)(MK-0773-005)
Condition: Sarcopenia
MeSH terms: Sarcopenia
Intervention: Comparator: MK-0773; Comparator: Placebo
Intervention description: MK-0773 50 mg tablets twice daily, 6 month treatment period; Placebo tablets twice daily, 6 month treatment period
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 170.0
Sex: Female
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Sarcopenia (loss of muscle mass)

Summary:

      A study to evaluate the safety, tolerability, and efficacy of MK-0773 in women with
      sarcopenia (loss of muscle mass).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is a woman who is 65 years of age or older

          -  Patient's lean body mass is at least 1 standard deviation below the mean of a healthy
             young adult population

          -  Patient has difficulty climbing 10 steps or walking outside on level ground for 1/4
             mile without resting or Activity Measure for Post Acute Care (AM-PAC)<66

        Exclusion Criteria:

          -  Patient has serious neurological, rheumatologic, cardiac, respiratory, kidney,
             psychiatric conditions

          -  Patient has a history of certain types of cancer
A Study to Assess the Effectiveness, Safety, and Pharmacokinetics of TMC435 in Combination With Peginterferon Alfa-2a and Ribavirin in Hepatitis-C Infected Patients
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: TMC435; PegIFNα-2a; RBV
Intervention description: One 50 or 100-mg capsule orally (by mouth), once daily for 12 or 24 weeks; One subcutaneous injection of PegIFNα-2a 180 μg once weekly for 12, 24, or 48 weeks.; 300, 400, or 500-mg tablets orally twice daily for 12, 24, or 48 weeks.
Intervention MeSH terms: Simeprevir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 92.0
Sex: All
Minimum age: 20 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hepatitis C; Hepatitis C virus; Interferon Alfa-2a; Ribavirin; Viral RNA

Summary:

      The purpose of this study is to evaluate effectiveness, safety and pharmacokinetics (Explores
      what the body does to the medication) of TMC435350 in combination with Peginterferon Alfa-2a
      and Ribavirin in genotype 1 hepatitis C virus infected Japanese participants who have never
      received treatment for their hepatitis C infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with documented chronic hepatitis C infection as evidenced by presence of
             HCV antibody at least 6 months (180 days) prior to the informed consent. -
             Participants with genotype 1 HCV infection. - Participants with plasma HCV RNA level
             of ≥ 5.0 log10 IU/mL at screening.

        Exclusion Criteria:

          -  Participants diagnosed with hepatic cirrhosis or hepatic failure. - Participants with
             any other liver disease than hepatitis C. - Participants with infection/co-infection
             with non-genotype 1 HCV.
The Study Will Evaluate the Efficacy of AZD5423 in Patients With Mild Asthma Challenged With an Inhaled Allergen
Condition: Asthma
MeSH terms: Asthma
Intervention: AZD5423; Budesonide 200 microgram; Placebo; Placebo
Intervention description: Suspension for nebulisation once daily 7 days; Dry powder for inhalation twice daily 7 days; Solution for nebulisation once daily 7 days; Solution for nebulisation once daily 7 days
Intervention MeSH terms: Budesonide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Allergen Challenge; Asthma; Inhaled selective glucocorticoid receptor agonist (iSEGRA)

Summary:

      The purpose of this study is to evaluate the efficacy of AZD5423 in patients with mild asthma
      challenged with an inhaled allergen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18-60 years of age

          -  Pre-bronchodilatory FEV1 ≥70% of predicted normal allergic asthmatic with a history of
             episodic wheeze

          -  Positive allergen induced early and late airway bronchoconstriction showing ≥ 20% fall
             in FEV1 for the early and ≥ 15% for the late response

          -  Positive skin prick test to common aeroallergens

        Exclusion Criteria:

          -  Any clinically significant disease or disorder

          -  Any clinically relevant abnormal finding at screening examinations

          -  Smoker or ex-smoker who has stopped smoking < 12 months prior to study start

          -  Worsening of asthma or respiratory infection within 6 weeks from visit 1

          -  Allergen-specific immunotherapy within 6 months prior to visit 1
Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 4 of 4)
Condition: Healthy Volunteers
Intervention: PRT064445/Edoxaban; Placebo/Edoxaban; Placebo
Intervention MeSH terms: Edoxaban
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study has four modules with a total of 21 cohorts, each module was reported and submitted separately.
Module 1, NCT01758432 (54 subjects with 7 cohorts including placebo); Module 2, NCT03578146 (48 subjects with 6 cohorts including placebo); Module 3, NCT03551730 (27 subjects with 4 cohorts including placebo); Module 4, NCT03551743 (28 subjects with 4 cohorts including placebo)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the ability of PRT064445 to reverse the effects of
      several blood thinner drugs on laboratory tests. The study also is evaluating the blood
      levels of PRT064445 given at different doses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy men or women between the ages of 18 and 45 years old

        Exclusion Criteria:

          -  History (including family history) or symptoms of, or risk factors for bleeding

          -  History (including family history) of or risk factors for a hypercoagulable or
             thrombotic condition

          -  Absolute/relative contraindication to anticoagulation or treatment with specific
             anticoagulants

          -  History of major surgery, severe trauma or bone fracture within 3 months prior to
             dosing; or planned surgery within 1 month after dosing
Phase II Study Efficacy and Safety of Two Dosing Regimens of MN-001 in Patients With Interstitial Cystitis
Condition: Interstitial Cystitis
MeSH terms: Cystitis; Cystitis, Interstitial
Intervention: MN-001 BID; MN-001; Placebo
Intervention description: Eligible patients received 500 mg MN-001 bid; Eligible patients received 500 mg MN-001 once daily (qd); Eligible patients received placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 296.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Interstitial Cystitis; urgency; frequency; MN-001; Global Response Assessment; bladder pain/urgency; O'Leary Sant IC Symptom and Problem Index

Summary:

      To evaluate the safety and efficacy of 8 weeks of treatment with MN-001 at 500 mg bid, 500 mg
      once daily vs. placebo in patients with Interstitial Cystitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥ 18 years of age with a diagnosis of moderate to severe IC;

          -  Bladder pain ≥ 6 months prior to baseline;

          -  Urinary frequency of ≥ 8 ≤ 30 micturitions within 24 hours while awake;

          -  Nocturia ≥ 2x/night;

          -  Males and females of child-bearing potential (not surgically sterile or
             post-menopausal) must be abstinent or agree to use an study-accepted contraceptive
             regimens throughout the study:

          -  Female patients of child bearing age must have a negative urine pregnancy test at
             screening;

          -  Must provide a signed informed consent.

        Exclusion Criteria:

          -  Male or females < 18 years of age;

          -  Initiation of new IC medication ≤ 30 days prior to baseline;

          -  Treatment with Elmiron ≤ 120 days prior to baseline;

          -  Treatment with bladder hydro-distention ≤ 6 months prior to baseline;

          -  Treatment with intravesical therapy ≤ 60 days prior to baseline;

          -  History of previous procedure(s) (e.g., augmentation cytoplasty, cystectomy or
             cystolysis) that has affected bladder function;

          -  Active genital herpes or vaginitis ≤ 90 days prior to baseline;

          -  Urinary tract or prostatic infection ≤ 90 days prior to baseline;

          -  History of urethral diverticulum;

          -  History of bladder or ureteral calculi;

          -  History of cyclophosphamide or chemical cystitis, urinary tuberculosis or radiation
             cystitis;

          -  History of bladder tumors;

          -  History of uterine, cervical, vaginal, prostatic or urethral cancer ≤ 5 years prior to
             baseline;

          -  Patient is currently pregnant, lactating or likely to become pregnant during the
             study;

          -  Participated in another clinical study with an investigational drug or device ≤ 30
             days prior to baseline.