bioihbjkbjnl/mcl2 huggingface dataset:
A Study Evaluating The Efficacy And Safety Of CP-690,550 In Patients With Moderate To Severe Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: tofacitinib; Placebo
Intervention description: 10 mg oral BID; Plabebo oral BID
Intervention MeSH terms: Tofacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 614.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: tofacitinib; CP-690; 550; Moderate to severe ulcerative colitis; phase 3 clinical trial; Mayo score

Summary:

      This study is designed to evaluate the efficacy and safety of tofacitinib (CP-690,550) in
      patients with moderate to severe ulcerative colitis who have failed or be intolerant to one
      of following treatments for ulcerative colitis: oral steroids,
      azathiopurine/6-mercaptopurine, or anti-TNF-alpha therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must be at least 18 years of age.

          -  Males and females with a documented diagnosis of UC at least 4 months prior to entry
             into the study.

          -  Subjects with moderately to severely active UC based on Mayo score criteria.

          -  Subjects must have failed or be intolerant of at least one of the following treatments
             for UC:

               -  Corticosteroids (oral or intravenous).

               -  Azathioprine or 6 mercaptopurine (6 MP).

               -  Anti TNF-alpha therapy.

        Exclusion Criteria:

          -  Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious
             colitis, or clinical findings suggestive of Crohn's disease.

          -  Subjects with disease limited to distal 15 cm.

          -  Subjects without previous treatment for UC (ie, treatment naïve).

          -  Subjects displaying clinical signs of fulminant colitis or toxic megacolon.
Dose-Ranging Study of Mometasone Furoate (MK-0887/SCH 032088) Nasal Spray in the Treatment of Children (Ages 6-11) With Seasonal Allergic Rhinitis (C95-161)
Condition: Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Mometasone furoate nasal spray; Beclomethasone dipropionate nasal spray; Placebo nasal spray; Chlorpheniramine maleate syrup
Intervention description: intranasal administration; intranasal administration; intranasal administration; oral administration
Intervention MeSH terms: Mometasone Furoate; Chlorpheniramine; Beclomethasone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 679.0
Sex: All
Minimum age: 6 Years
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to identify the lowest dosage of mometasone furoate nasal spray
      (MFNS) that provided adequate efficacy with an acceptable safety profile for children (ages
      6-11) with seasonal allergic rhinitis (SAR). The MFNS dose levels of 25, 100, and 200 mcg QD
      were compared with beclomethasone dipropionate (BDP), as an active control, and placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have at least a one-year history of seasonal allergic rhinitis which previously
             required treatment for tree and/or grass pollen

          -  Have a positive skin test response to an appropriate tree and/or grass seasonal
             allergen within the last year.

          -  Must be free of any clinically significant disease other than seasonal allergic
             rhinitis.

          -  Must be pre-menarcheal.

        Exclusion Criteria:

          -  History of asthma which requires chronic use of inhaled or systemic corticosteroids.

          -  Current or history of frequent, clinically significant sinusitis or chronic purulent
             postnasal drip.

          -  History of rhinitis medicamentosa.

          -  History of clinically significant nasal candidiasis.

          -  History of multiple drug allergies or allergy/intolerance to corticosteroids or
             antihistamines.

          -  History of upper respiratory tract or sinus infection that required antibiotic therapy
             within the previous 2 weeks, or viral upper respiratory infection within 7 days prior
             to Screening.

          -  History of nasal structural abnormalities, including large nasal polyps and marked
             septal deviation, that significantly interfere with nasal air flow.

          -  History of dependence upon nasal, oral or ocular decongestants, or nasal topical
             antihistamines.

          -  History of investigational drug use in the last 30 days.

          -  History of immunotherapy (desensitizing therapy), unless on a stable maintenance
             schedule for at least one month prior to Screening.
HOPE-B: Trial of AMT-061 in Severe or Moderately Severe Hemophilia B Patients
Condition: Hemophilia B
MeSH terms: Hemophilia A; Hemophilia B
Intervention: AAV5-hFIXco-Padua; Factor IX (FIX)
Intervention description: Single intravenous infusion of AAV5-hFIXco-Padua (AMT-061); During the lead-in phase, which lasted for a minimum of 26 weeks (i.e., ≥6 months), subjects recorded their use of FIX replacement therapy and bleeding episodes in their dedicated e-diary.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: The reference therapy is prophylactic factor IX replacement therapy used during the lead-in phase prior to treatment with AAV5-hFIXco-Padua (AMT-061).
Masking: None (Open Label)
Enrollment: 67.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Gene therapy; FIX; factor IX; Bleeding; Viral vector; Padua; hemophilia; AAV (adeno-associated virus); serotype 5 AAV (adeno-associated virus); serotype 5

Summary:

      This is an open-label, single-dose, multi-center, multinational trial to demonstrate the
      efficacy of AMT-061 and to further describe its safety profile.

      The study drug is identified as AAV5-hFIXco-Padua (AMT- 061). AMT-061 is a recombinant
      adeno-associated viral vector of serotype 5 (AAV5) containing the Padua variant of a
      codon-optimized human FIX complementary deoxyribonucleic acid (cDNA) under the control of a
      liver-specific promoter. The pharmaceutical form of AMT-061 is a solution for intravenous
      infusion administered at a dose of 2 x 10^13 gc/kg.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male

          2. Age ≥18 years

          3. Subjects with congenital hemophilia B, classified as severe or moderately severe, and
             are currently on factor IX prophylaxis

          4. >150 previous exposure days of treatment with factor IX protein

        Exclusion Criteria:

          1. History of factor IX inhibitors

          2. Positive factor IX inhibitor test at screening

          3. Select screening laboratory value >2 times upper limit of normal

          4. Positive human immunodeficiency virus (HIV) test at screening, not controlled with
             anti-viral therapy

          5. Active infection with hepatitis B or C virus at screening

          6. History of Hepatitis B or C exposure, currently controlled by antiviral therapy at the
             end of the lead-in phase

          7. Previous gene therapy treatment

          8. Receipt of an experimental agent within 60 days prior to screening

          9. Current participation or anticipated participation within one year after study drug
             administration in this trial in any other interventional clinical trial involving
             drugs or devices
PRELUDE:Study to Investigate the Prevention of Relapse in Lymphoma Using Daily Enzastaurin
Condition: Non Hodgkin Lymphoma
MeSH terms: Lymphoma
Intervention: enzastaurin; placebo
Intervention description: 1125 mg loading dose then 500 mg, oral, daily, until disease progression or maximum of 3 years; oral, daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 758.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This clinical research study is to investigate the prevention of relapse in patients with
      diffuse large B cell lymphoma (DLBCL) using enzastaurin daily.

      This is a randomised trial which compares Enzastaurin to Placebo (dummy treatment), the
      chance of receiving Enzastaurin is 2 to 1.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of diffuse large B cell lymphoma

          -  Recently completed R-CHOP therapy and achieved remission

          -  International Prognostic Index (IPI) score 3,4,5

          -  At least 18 years of age

          -  Agree to study follow-up schedule

        Exclusion Criteria:

          -  Have received therapy other than R-CHOP for lymphoma

          -  Serious medical condition such as infection,second cancer,heart disease

          -  Received radiation to more than one lesion

          -  Unable to swallow tablets
Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Intervention: Placebo plus standard therapy; Belimumab 10 mg/kg plus standard therapy; Standard therapy
Intervention description: Placebo plus standard therapy; Belimumab 10 mg/kg plus standard therapy; The standard therapies allowed in this study are:
- High-dose steroids (for example, methylprednisolone) plus cyclophosphamide for induction therapy followed by azathioprine for maintenance therapy
OR
- High-dose steroids plus mycophenolate for induction therapy followed by mycophenolate for maintenance therapy
Intervention MeSH terms: Belimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 448.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Antibodies; Systemic Lupus Erythematosus; Autoimmune Disease; Glomerulonephritis; Belimumab; Lupus; Nephritis; Kidney Diseases; SLE

Summary:

      The purpose of this study is to evaluate the efficacy, safety, and tolerability of belimumab
      in adult patients with active lupus nephritis.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.

          -  Biopsy confirmed active lupus nephritis.

          -  Clinically active lupus renal disease at screening requiring /receiving induction
             therapy with Standard of Care medications.

          -  Autoantibody-positive.

        Key Exclusion Criteria:

          -  Pregnant or nursing.

          -  On dialysis within the past year.

          -  Treatment with belimumab within the past year .

          -  Receipt of induction therapy with cyclophosphamide within 3 months prior to induction
             therapy for the study.

          -  Receipt of any B cell targeted therapy (for example, rituximab), investigational
             biological agent within the past year.

          -  Severe active central nervous system (CNS) lupus.

          -  Required management of acute or chronic infections within the past 60 days.

          -  Current drug or alcohol abuse or dependence.

          -  Tested positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.

          -  History of severe allergic reaction to contrast agents or biological medicines.
NEXUS Study for the Treatment of de Novo Native Coronary Artery Lesions
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Intervention: CYPHER NxT SES ON BX SONIC OTW STENT DELIVERY SYSTEM (SDS)
Intervention description: CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the effectiveness and safety of the CYPHER NxT
      Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-Wire (OTW) Stent Delivery System
      (SDS) in patients with de novo native coronary artery lesions.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or non-pregnant female patients 18 years of age

          2. Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society
             Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald
             Classification B&C, I-II) OR patients with documented silent ischemia;

          3. Treatment of a single de novo target lesion in a major native coronary artery;

          4. Target lesion is 2.5 mm and 3.5 mm in diameter (visual estimate);

          5. Target lesion is 30mm in length (visual estimate);

          6. Target lesion stenosis is > 50% and < 100% (visual estimate);

        Exclusion Criteria:

          1. Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented
             total CK > 2 times normal within the preceding 24 hours and the CK and CK-MB enzymes
             remain above normal at the time of treatment;

          2. Has unstable angina classified as Braunwald III B or C, or is having a peri-infarction
             angina;

          3. Significant (> 50%) stenoses proximal or distal to the target lesion that might
             require revascularization or impede runoff;

          4. Documented Left ventricular ejection fraction 25%;

          5. Totally occluded vessel (TIMI 0 level);

          6. Impaired renal function (creatinine > 3.0 mg/dl) at the time of treatment;
A Double-blind, Double-dummy, Parallel, Active-controlled, Randomized Trial to Evaluate Efficacy & Safety in Anemia Subjects
Condition: Iron Deficiency Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Intervention: Ferrous (II) Glycine Sulphate Complex; Polyferose; Placebo to Ferrous (II) Glycine Sulphate Complex; Placebo to Polyferose
Intervention description: Oral dose of 567.7 mg Ferrous (II) Glycine Sulphate Complex three times a day (t.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).
Administered orally with water.; Oral dose of 150 mg Polyferose Capsules twice daily (b.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).
Administered orally with water.; Administered orally with water.; Administered orally with water.
Intervention MeSH terms: Glycine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 256.0
Sex: All
Minimum age: 16 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Ferrous (II) Glycine Sulphate Complex; Polyferose; Ferro Sanol duodenal; Niferex; Iron Deficiency Anemia

Summary:

      To evaluate the efficacy and safety of 12 weeks treatment with Ferrous (II) Glycine Sulphate
      Complex in comparison to Polyferose capsules in Chinese subjects with manifest Iron
      Deficiency Anemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  An iron deficiency anemia patient with Serum Ferritin < 12 ng/mL, serum Hb-values >60
             and < 120 g/L in males, < 110 g/L in females

        Exclusion Criteria:

          -  With any Mal-absorption Syndrome

          -  With a history of Thalassemia or Sickle Cell Anemia

          -  With untreated concurrent Vitamin B12 or Folate deficiency at Baseline
A Study of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults With Chronic Hepatitis C Virus (HCV) Genotype 1-6 Infection and Compensated Cirrhosis
Condition: Hepatitis C Virus (HCV)
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Liver Cirrhosis; Fibrosis
Intervention: Glecaprevir/Pibrentasvir
Intervention description: Tablet
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 343.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatitis C Virus (HCV); Glecaprevir; Pibrentasvir; Treatment Naïve; Cirrhosis; Compensated Cirrhosis; Genotype (GT) 1-6; Pangenotypic; Chronic Hepatitis C Virus (HCV)

Summary:

      A Phase 3b, single arm, open-label, multicenter study in treatment naïve adults with chronic
      HCV infection and compensated cirrhosis to assess the safety of 8 weeks of treatment with
      glecaprevir/pibrentasvir and to demonstrate the efficacy of the sustained virologic response
      12 weeks post dosing (SVR12) rates of 8 weeks of treatment with glecaprevir/pibrentasvir
      compared to the historical SVR12 rates of 12 weeks of treatment with
      glecaprevir/pibrentasvir.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Screening laboratory result indicating Hepatitis C Virus (HCV) Genotype (GT) 1-6
             infection.

          -  Positive plasma HCV antibody and HCV RNA viral load greater than or equal to 1000
             IU/mL at Screening.

          -  Treatment-naive to any approved or investigational anti-HCV medication.

          -  Participant must be documented as cirrhotic, with a Child-Pugh score of less than or
             equal to 6.

        Exclusion Criteria:

          -  Female participant who is pregnant, breastfeeding or is considering becoming pregnant
             during the study, or for approximately 30 days after the last dose of study drug.

          -  Any current or historical clinical evidence of decompensated cirrhosis.

          -  Positive test result at Screening for hepatitis B surface antigen (HBsAg), HBV
             deoxyribonucleic acid > lower limit of quantification (LLOQ) in subjects with isolated
             positive antibody to hepatitis B core antigen (anti-HBc) (i.e., negative HBsAg and
             anti-hepatitis B),or anti human immunodeficiency virus antibody (HIV Ab).

          -  HCV genotype performed by the central laboratory during screening indicating
             co-infection with more than one HCV genotype.

          -  History of suspected or confirmed hepatocellular carcinoma.
PSUNRISE - Prospective Study Using Remicade in Psoriasis Patients With an Inadequate Response to Etanercept
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: infliximab
Intervention description: Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
Intervention MeSH terms: Infliximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 217.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: plaque psoriasis; psoriasis; infliximab; remicade; etanercept; enbrel; psunrise; C0168Z04

Summary:

      The purpose of this study is to test the safety and effectiveness of infliximab in patients
      with plaque psoriasis who have been receiving the drug etanercept for treatment of their
      plaque psoriasis for at least four months, without enough improvement in their psoriasis
      symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have plaque psoriasis despite at least 4 months of treatment with etanercept per
             current product labeling

          -  Have psoriatic target lesions that have a PGA score greater than 1 (minimal) at
             screening

          -  If receiving methotrexate at screening, must have received methotrexate for at least 3
             months and at a stable dose of <= 25 mg/week for at least 4 weeks prior to screening

          -  If receiving cyclosporine at screening, must have received cyclosporine at a stable
             dose of <= 5 mg/kg daily for at least 4 weeks prior to screening.

        Exclusion Criteria:

          -  Have already received infliximab or adalimumab

          -  Have shown a previous immediate hypersensitivity response, including anaphylaxis, to
             an immunoglobulin product

          -  Have a history of latent or active granulomatous infection, including tuberculosis,
             histoplasmosis, or coccidioidomycosis, prior to screening

          -  Have a concomitant diagnosis or any history of Congestive Heart Failure

          -  Are pregnant, nursing, or planning pregnancy

          -  Have used systemic corticosteroids within the 4 weeks prior to screening

          -  Have used topical corticosteroids or have initiated treatment with other topical
             therapies that could affect psoriasis or Psoriasis Area and Severity Index (PASI)
             evaluation (e.g., tar, anthralin, calcipotriene, tazarotene, methoxsalen) within 2
             weeks prior to screening

          -  Have used new systemic agents/treatments, other than methotrexate, that can affect
             psoriasis including, but not limited to, immunosuppressants and/or psoralen plus
             ultraviolet A light (PUVA) within the 4 weeks prior to screening.
Clinical Trial of the Use of Intraperitoneal Local Anaesthetic
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Nebulised Bupivacaine intraperitoneally; Normal Saline; Injected Bupivacaine intraperitoneally; No Intraperitoneal Therapeutics
Intervention description: Nebulised Marcaine (Bupivacaine); Nebulised Normal Saline; Injected Marcaine directly into the peritoneal cavity; No Intraperitoneal Therapeutics given
Intervention MeSH terms: Bupivacaine; Coal Tar
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pain; Nebulisation; Cholecystectomy; Laparoscopic; Bupivacaine; Local Anaesthetic

Summary:

      Patients undergoing keyhole gall bladder removal will be divided into 3 groups, one control,
      one will have local anaesthetic and the third will have normal saline nebulised into their
      abdomen before closure of the wounds to reduce postoperative pain. These medications will be
      given on top of the standard pain management protocol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All they patients undergoing laparoscopic cholecystectomy will be included.

        Exclusion Criteria:

          -  Patients with local anaesthetic allergy, patients on chronic opiate medication or
             those with neurological diseases that make pain evaluation unreliable will be
             excluded.