bioihbjkbjnl/mcl2 huggingface dataset:
Studies of the Ocular Complications of AIDS (SOCA)--Cytomegalovirus Retinitis Retreatment Trial (CRRT)
Condition: HIV Infections; Acquired Immunodeficiency Syndrome; Cytomegalovirus Retinitis
MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome; Cytomegalovirus Retinitis; Retinitis; Immunologic Deficiency Syndromes
Intervention: Ganciclovir; Foscarnet
Intervention description: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day; intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day
Intervention MeSH terms: Ganciclovir; Ganciclovir triphosphate; Foscarnet
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Enrollment: 279.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To compare the relative merits of three therapeutic regimens in patients with AIDS and CMV
      retinitis who have been previously treated but whose retinitis either is nonresponsive or has
      relapsed. These three therapeutic regimens were (1) foscarnet, (2) high-dose ganciclovir, and
      (3) combination foscarnet and ganciclovir.

      To compare two treatment strategies in patients with relapsed or nonresponsive CMV retinitis:
      (1) continuing the same anti-CMV drug or (2) switching to the alternate drug.
    

Eligibility criteria:

        inclusion criteria: Males and females eligible for the CRRT must have been age 18 years or
        older and have had AIDS and CMV retinitis. They must have had active CMV despite a minimum
        of 28 days of previous treatment with an anti-CMV drug. Furthermore, they must have had an
        absolute neutrophil count greater than or equal to 500 cells/µL, platelet count greater
        than or equal to 20,000 cells/µL, and a serum creatinine < 2.5 mg/dL in order to tolerate
        the drug regimens.

        exclusion criteria: history of intolerance to ganciclovir or foscarnet, history of therapy
        involving the combination of foscarnet and ganciclovir, unwillingness to practice
        appropriate birth control, active drug or alcohol abuse, media opacity, retinal detachment
        not scheduled for surgical repair
The Bladder Instillation Comparison Study
Condition: Urinary Bladder Neoplasms
MeSH terms: Urinary Bladder Neoplasms
Intervention: Mitomycin C; Gemcitabine
Intervention description: Cancer chemotherapeutic agent; Cancer chemotherapeutic agent
Intervention MeSH terms: Gemcitabine; Mitomycins; Mitomycin
Phase: Phase 3
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: bladder tumors; urinary tumors; non-muscle invasive bladder tumors; NMIBC

Summary:

      To compare the efficacy of Mitomycin C vs. Gemcitabine vs. no adjuvant treatment as a single
      intraoperative instillation in preventing recurrence of bladder cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. sign an informed consent for the study

          2. be scheduled for a TURBT for suspected non-muscle invasive bladder tumor.

        Exclusion Criteria:

          1. patients unable to consent for themselves

          2. individuals under 18 years old

          3. pregnant women

          4. prisoners

          5. patients with known allergy or intolerance to the mitomycin C or Gemcitabine

          6. any other sound medical, psychiatric and/or social reason as determined by the
             investigator.
Study to Investigate the Safety and Pharmacokinetics of SER120 Nasal Spray in Elderly Patients With Nocturia
Condition: Nocturia
MeSH terms: Nocturia
Intervention: SER120 Nasal Spray 500 ng/day; SER120 nasal spray 750 ng/day
Intervention description: SER120 Level 1; SER120 (750 ng/day)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 75 Years
Maximum age: 95 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if SER120 nasal spray is well tolerated in 75 years
      or older nocturic patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male & female greater or equal to 75 years of age, history of nocturia

        Exclusion Criteria:

          -  CHF, Diabetes, Diabetes Insipidus, Renal Insufficiency, Heptatic Insufficiency,
             Incontinence, Illness requiring steroid, current or past urologic maliganancy,
             nephrotic syndrome

          -  Unexplained pelvic masses

          -  Urinary bladder surgery or radiotherapy

          -  Sleep apnea
Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile - Associated Diarrhea
Condition: Clostridium Difficile Infection
MeSH terms: Clostridium Infections; Diarrhea
Intervention: Cadazolid; Vancomycin; Cadazolid-matching placebo; Vancomycin-matching placebo
Intervention description: Cadazolid 250 mg as oral suspension twice daily.; Vancomycin 125 mg as oral capsules 4 times daily.; Placebo matching cadazolid and administered orally twice daily; Placebo capsules matching vancomycin and administered orally 4 times per day
Intervention MeSH terms: Vancomycin; Oxazolidinones
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 632.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Post-antibiotic diarrhea; Clostridium difficile infection

Summary:

      This clinical study is conducted to assess the efficacy of cadazolid compared to vancomycin
      in subjects with Clostridium difficile-associated diarrhea (CDAD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed Informed Consent.

          -  Male or female ≥ 18 years of age. Females of childbearing potential must agree to use
             an adequate and reliable method of contraception.

          -  Subject with a diagnosis of mild-moderate or severe CDAD (first occurrence or first
             recurrence within 3 months) with: Diarrhea: a change in bowel habits with > 3 liquid
             or unformed bowel movements (UBM) within 24 hours prior to randomization, AND Positive
             C. difficile toxin test on a stool sample produced within 72 hours prior to
             randomization.

        Exclusion Criteria:

          -  More than one previous episode of CDAD in the 3-month period prior to randomization.

          -  Evidence of life-threatening or fulminant CDAD.

          -  Likelihood of death within 72 hours from any cause.

          -  History of inflammatory colitides, chronic abdominal pain, or chronic diarrhea.

          -  Antimicrobial treatment active against CDAD administered for > 24 hours except for
             metronidazole treatment failures (MTF)

          -  Known hypersensitivity or contraindication to study drugs, oxazolidinones, or
             quinolones.

          -  Unable or unwilling to comply with all protocol requirements.

          -  Any circumstances or conditions, which, in the opinion of the investigator, may affect
             full participation in the study or compliance with the protocol
Evaluation of Recombinant Factor XIII for Prevention of Bleeding in Patients With FXIII Inherited Deficiency
Condition: Congenital Bleeding Disorder; Congenital FXIII Deficiency
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders; Hemorrhage
Intervention: catridecacog
Intervention description: 35 IU/kg body weight, i.v. administration, once every 4 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No

Summary:

      The trial is conducted in Europe, North America and Asia. The aim of this trial is to
      evaluate catridecacog (recombinant factor XIII (rFXIII)) treatment in patients with inherited
      FXIII deficiency. It is expected that recombinant FXIII can be used for the prevention of
      bleeding episodes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of congenital FXIII A-subunit deficiency (confirmed by genotyping at
             screening visit)

          -  Treatment with regular FXIII replacement therapy initiated at least 6 months prior to
             screening and one of the following : a documented history of at least one 1
             treatment-requiring bleeding episode prior to initiation of regular replacement
             therapy or a documented family history of FXIII congenital deficiency (only for
             subjects on regular replacement therapy prior to screening)

          -  Documented history of at least two 2 bleeding episodes requiring treatment with FXIII
             containing blood products within the last 12 months prior to screening (only for
             subjects receiving on-demand treatment prior to screening)

        Exclusion Criteria:

          -  Known neutralizing antibodies (inhibitors) towards FXIII

          -  Any known congenital or acquired coagulation disorder other than congenital FXIII
             deficiency

          -  Documented history of at least 2 treatment-requiring bleeding episodes per year during
             previous regular replacement therapy with FXIII containing blood products (fresh
             frozen plasma (FFP), plasma-derived FXIII (pd FXIII) and cryoprecipitate)

          -  Known or suspected allergy to trial product(s) or related products

          -  Planned major surgery during the trial period. Catheter, ports and dental extractions
             do not count as surgeries and will not exclude the subject

          -  Renal insufficiency defined as current dialysis therapy

          -  Any history of confirmed venous or arterial thrombo-embolic events
HX575 Epoetin Alfa Subcutaneously (s.c.) in Chronic Kidney Disease (CKD)
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Intervention: HX575 epoetin alfa (Sandoz)
Intervention description: Eligible patients are scheduled to receive HX575 (INN: Epoetin alfa) as a solution for injection in order to achieve or maintain the correction of renal anemia.
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 417.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Epoetin alfa, ESA, HX575, CKD

Summary:

      The study will assess the immunogenicity, safety, and efficacy of HX575 epoetin alfa
      administered subcutaneously (s.c.) in patients suffering from anemia due to chronic kidney
      disease (CKD)
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Adult male and female patients w or w/o dialysis treatment

          -  Stable i.v. or s.c. maintenance therapy with an EU-approved ESA treatment or ESA
             naïve.

          -  Adequate iron substitution

        Main Exclusion Criteria:

          -  History of Pure Red Cell Aplasia (PRCA) or anti-erythropoietin (EPO) antibodies

          -  Contraindications for ESA therapy

          -  Serum albumin < 3.0 g/dL

          -  Immunocompromized patients (immunosuppressive treatment, chemotherapy)

          -  Hepatitis C infection on an active treatment or hepatitis B or human immunodeficiency
             virus (HIV) infection

          -  Systemic lupus erythematosus

          -  Symptomatic congestive heart failure, Unstable angina pectoris, or myocardial
             infarction within 6 months

          -  History of malignancy of any organ system within the last 5 years

          -  History of use of any non-EU approved ESA
Randomised Placebo-controlled Duloxetine-referenced Study of Efficacy and Safety of 15 and 20 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in Adults
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Placebo; Vortioxetine (Lu AA21004); Duloxetine
Intervention description: capsules, daily, orally; encapsulated tablets, daily, orally; encapsulated capsules, daily, orally
Intervention MeSH terms: Duloxetine Hydrochloride; Vortioxetine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 607.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Major depressive disorder; Placebo-controlled; Active reference; Multicenter study; Randomised study; Acute treatment

Summary:

      The purpose of the study is to evaluate the efficacy, tolerability and the safety of two
      fixed doses of vortioxetine in the treatment of major depressive disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient has recurrent MDD as the primary diagnosis according to DSM-IV-TR™
             criteria (classification code 296.3x)

          -  The patient has a MADRS total score >=26

          -  The patient has a CGI-S score >=4

          -  The patient has had the current episode of MDE for >3 months

        Exclusion Criteria:

          -  Any current anxiety psychiatric disorder as defined in the DSM-IV TR

          -  Current diagnosis or history of manic or hypomanic episode, schizophrenia or any other
             psychotic disorder, including major depression with psychotic features, mental
             retardation, organic mental disorders, or mental disorders due to a general medical
             condition as defined in the DSM-IV TR

          -  Current diagnosis or history of alcohol or other substance abuse or dependence
             (excluding nicotine or caffeine) as defined in the DSM-IV TR

          -  Use of any psychoactive medication 2 weeks prior to screening and during the study

          -  The patient is at significant risk of suicide or has a score >=5 on Item 10 (suicidal
             thoughts) of the MADRS, or has attempted suicide within 6 months prior to the
             Screening Visit

        Other protocol-defined inclusion and exclusion criteria may apply.
Glucose Response of G-Pen (Glucagon Injection) in Pediatric T1D Patients
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus, Type 1
Intervention: Glucagon
Intervention description: 0.5 or 1.0 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This is a sequential efficacy and safety study in pediatric patients with type 1 diabetes.
      Subjects will be administered insulin to induce a low normal glycemic state and will then
      receive an age-appropriate dose of G-Pen (glucagon injection) in a clinical research center
      (CRC) or comparable setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  diagnosed with T1D for at least 6 months at Screening.

          -  current usage of daily insulin treatment.

        Exclusion Criteria:

          -  pregnant or nursing

          -  renal insufficiency

          -  hepatic synthetic insufficiency

          -  aspartate or alanine aminotransferase > 3 times the upper limit of normal

          -  hematocrit less than or equal to 30%

          -  use of > 2.0 U/kg total insulin dose per day

          -  inadequate venous access

          -  current seizure disorder

          -  history of pheochromocytoma or disorder with increased risk of pheochromocytoma

          -  history of insulinoma

          -  history of glycogen storage disease.

          -  active use of alcohol or drugs of abuse

          -  administration of glucagon within 14 days of the first treatment visit

          -  participation in other studies involving an investigational drug or device within 30
             days
Phase 3 Study of Imiquimod Creams in the Treatment of External Genital Warts
Condition: Genital Warts
MeSH terms: Warts; Condylomata Acuminata
Intervention: 2.5% imiquimod cream; 3.75% imiquimod cream; Placebo cream
Intervention description: 2.5% imiquimod cream applied daily to wart areas for up to 8 weeks.; 3.75% imiquimod cream applied daily to wart areas for up to 8 weeks; Placebo cream applied daily to wart areas for up to 8 weeks
Intervention MeSH terms: Imiquimod
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 511.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: external genital warts; perianal warts; condylomata acuminata; human papilloma virus; HPV types 6 and 11

Summary:

      The purpose of this study is to determine whether imiquimod creams are effective in treating
      external genital warts (EGW). The secondary objective of this study is to provide information
      on recurrence of EGW. Additionally the study will also look at any adverse events associated
      with the use of the creams.

      External genital and perianal warts are caused by the infection of human papillomavirus or
      HPV. HPV infection is a sexually transmitted disease (STD). External genital warts look like
      small flesh-colored, pink, or red growths on or around the external skin of sex organs or
      perianal area. The warts may look similar to the small parts of a cauliflower or they may be
      very tiny and difficult to see. They often appear in clusters of three or four, and may grow
      and spread rapidly. They usually are not painful, although they may cause mild pain,
      bleeding, and itching.
    

Eligibility criteria:

        Inclusion Criteria:

          -  In good general health

          -  Diagnosis of external genital / perianal warts with at least 2 warts and no more than
             30 warts

          -  Negative pregnancy test (for women who are able to become pregnant)

        Exclusion Criteria:

          -  Women who are pregnant, lactating or planning to become pregnant during the study

          -  Evidence of clinically significant or unstable disease (such as stroke, heart attack)

          -  Have any of the following conditions: HIV infection; current or history of high risk
             HPV infection (e.g., HPV types 16, 18, etc.); outbreak of herpes genitalia in the wart
             areas; internal warts requiring or undergoing treatment; dermatological disease (e.g.,
             psoriasis) or skin condition in the wart areas

          -  Have received specific treatments in the treatment area(s) within the designated time
             period prior to study treatment initiation
A Study of RoActemra/Actemra and, if Initially Inadequately Responded to RoActemra/Actemra, Followed by MabThera/Rituxan in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: rituximab [MabThera/Rituxan]; tocilizumab [RoActemra/Actemra]; tocilizumab [RoActemra/Actemra]
Intervention description: 1 g intravenously at Week 16 and 18; 8 mg/kg intravenously every 4 weeks for 12 weeks.; 8 mg/kg intravenously every 4 weeks from Week 16 to Week 28
Intervention MeSH terms: Rituximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 519.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label, multi-center, two-arm, uncontrolled and non-randomized study will evaluate
      the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid
      arthritis. Patients will receive 8 mg/kg RoActemra/Actemra intravenously every 4 weeks for 12
      weeks and - if adequately responded - for further 12 weeks. Patients, who show an inadequate
      clinical response after the first 12 weeks to RoActemra/Actemra, will receive 1 g
      MabThera/Rituxan (rituximab) intravenously at Week 16 and 18. The anticipated time of study
      treatment is 32 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients >/=18 years of age

          -  Body weight < /=130kg

          -  Active rheumatoid arthritis of at least 6 months duration, diagnosed according to the
             American College of Rheumatology (ACR) criteria of 1987

          -  Disease Activity Score (DAS28) of >3.2

          -  Inadequate clinical response to a stable dose of traditional Disease-Modifying
             Anti-Rheumatic Drugs (DMARD)

          -  Have received permitted DMARDs, one or more; current DMARD therapy must have been at
             stable dose for at least 4 weeks prior to baseline

        Exclusion Criteria:

          -  Prior treatment with TNF-inhibitors or other biologic DMARD

          -  Major surgery (including joint surgery) within eight weeks prior to baseline or
             planned major surgery within the study duration

          -  Functional class IV (American College of Rheumatology classification)

          -  Rheumatic autoimmune disease other than rheumatoid arthritis

          -  History of or current inflammatory joint disease other than rheumatoid arthritis