bioihbjkbjnl/mcl2 huggingface dataset:
P03277 Dose Finding Study in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
Condition: CNS Lesion; Blood Brain Barrier Defect
Intervention: P03277; Gadobenate dimeglumine; MRI
Intervention description: Single intravenous (IV) bolus injection at a rate of 2 mL/second; Single IV bolus injection at a rate of 2 mL/second
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 312.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to determine a safe and effective dose of a new
      gadolinium-based contrast agent (GBCA) P03277 based on the Contrast to Noise Ratio (CNR) when
      comparing with gadobenate dimeglumine (MultiHance®) at 0.1 mmol/kg body weight (BW).

      Contrast to Noise Ratio (CNR), a well-known quantitative parameter directly related to
      contrast medium/GBCA efficacy, was chosen as the primary endpoint in order to have a precise
      determination of P03277 clinical dose.

      This was a multi-center, international, prospective, double-blind, randomized, controlled,
      parallel dose groups, cross-over with comparator study in male and female subjects presenting
      with known or highly suspected focal areas of disruption of the Blood Brain Barrier including
      at least one expected enhancing lesion of minimum 5 mm, who were scheduled to undergo a
      routine contrast-enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female or male adult subjects, with known or highly suspected focal areas of disrupted
             Blood Brain Barrier including at least one expected enhancing lesion of minimum 5 mm
             (long axis). This lesion had been detected on a previous imaging procedure
             (computerized Tomography [CT] or MRI).

          -  Subject scheduled for a routine contrast-enhanced MRI examination of Central Nervous
             System for clinical reasons and agreeing to have a second contrast-enhanced MRI
             examination for the purpose of the study.

        Exclusion Criteria:

          -  Subject presenting with acute or chronic Grade III (at least) renal insufficiency,
             defined as an estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.73 m² based on
             one eGFR assessment performed the day of the MRI prior to the first contrast agent
             injection.
A Safety, Pharmacokinetics and Efficacy Study of MAU868 for the Treatment of BK Viremia in Kidney Transplant Recipients
Condition: BK Virus Infection
MeSH terms: Viremia
Intervention: MAU868; Placebo
Intervention description: MAU868 is a human monoclonal antibody (IgG1) that binds the viral capsid protein, VP1, that is responsible for binding to the surface of host cells; 250 mL D5W placebo IV to be labeled to match that of MAU868
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This clinical research study will test the safety and efficacy of the investigational
      medication MAU868, compared to a placebo, in patients who have had a kidney transplant who
      have active BK virus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be a male or female 18 years of age or older.

          -  Recipient of a kidney (or kidney-pancreas) transplant within the year prior to
             enrollment

          -  Documented BKV viremia based on local or central laboratory testing within 10 days

        Exclusion Criteria:

          -  A BKV plasma viral load which has exceeded 10^3 copies/mL for >4 months.

          -  A BKV plasma viral load of ≥ 10^7 copies/mL.
Autologous Fecal Therapy
Condition: Infectious Disease of Digestive Tract
MeSH terms: Communicable Diseases; Infections
Intervention: Autologous fecal microbiota therapy; Placebo
Intervention description: Saline enema
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Fecal microbiota therapy

Summary:

      Ten healthy volunteers will be recruited to receive either an autologous stool transplant or
      a saline enema to determine if autologous fecal microbiota therapy will be able to rapidly,
      and safely, restore a patient's fecal microbiome after antimicrobial exposure.
    

Eligibility criteria:

        Inclusion Criteria:

        Healthy Adults 18-70 years of age-

        Exclusion Criteria:

        history of allergic reaction to beta-lactam antimicrobials; any non-topical antimicrobial
        exposure or tube feeds as a primary source of nutrition in the past six months; pregnant or
        risk of becoming pregnant during the study period; gastroenteritis in the last 3 months;
        incontinent of stool; prior resection or alteration of the stomach; small bowel, or colon;
        unwillingness to receive an enema/FMT; known colonization with an MDRO; anticipated change
        in diet or medications, or elective surgery, during the study period; or a history of an
        intestinal disorder -
A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma
Condition: Advanced Cholangiocarcinoma; FGFR2 Gene Mutation
MeSH terms: Cholangiocarcinoma
Intervention: BGJ398 (infigratinib)
Intervention description: Capsule for oral use
Intervention MeSH terms: Infigratinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 143.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cholangiocarcinoma,; FGFR2 gene fusion,; FGFR genetic alteration

Summary:

      This is a multi-center, open label, single arm phase II study evaluating BGJ398
      (infigratinib) anti-tumor activity in advanced or metastatic cholangiocarcinoma patients with
      fibroblast growth factor receptor (FGFR) genetic alterations.
    

Eligibility criteria:

        Inclusion criteria:

        - Adult patients with histologically or cytologically confirmed cholangiocarcinoma at the
        time of diagnosis.

        Patients with cancers of the gallbladder or ampulla of Vater are not eligible.

        - Patients must have received at least one prior regimen containing gemcitabine with or
        without cisplatin for advanced/ metastatic disease. Patient should have evidence of
        progressive disease following prior regimen, or if prior treatment discontinued due to
        toxicity must have continued evidence of measurable or evaluable disease.

        Exclusion criteria:

          -  Prior or current treatment with a MEK inhibitor (all Cohorts), BGJ398 (infigratinib)
             (all Cohorts), or selective FGFR inhibitor (Cohorts 1 and 2 only).

          -  insufficient organ function

               -  Absolute Neutrophil Count (ANC) < 1,000/mm3 [1.0 x 10^9/L]

               -  Platelets < 75,000/mm3 [75 x 10^9/L]

               -  Hemoglobin < 109.0 g/dL

               -  Total bilirubin > 1.5x upper limit of normal (ULN)

               -  Aspartate aminotransferase/glutamic oxaloacetic transaminase (AST/SGOT) and
                  alanine aminotransferase/glutamic pyruvic transaminase (ALT/SGPT) > 2.5x ULN (AST
                  and ALT > 5x ULN in the presence of liver metastases)

               -  Serum creatinine > 1.5x ULN and a calculated or measured creatinine clearance <
                  45 mL/min

               -  Inorganic phosphorus outside of normal limits

               -  Total and ionized serum calcium outside of normal limits

        Other protocol-defined inclusion/exclusion criteria may apply.
Cervical Preparation With Mifepristone Prior to Osmotic Dilators
Condition: Second Trimester Abortion
Intervention: Mifepristone 200 MG; Placebo Oral Tablet
Intervention description: Ingestion of study medication vs placebo; Ingestion of study medication vs placebo
Intervention MeSH terms: Mifepristone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 44.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The investigators plan to study the role of mifepristone prior to the placement of cervical
      osmotic dilators to evaluate if the medication helps increase the number of dilators. This
      may help improve safety of dilation and evacuation (D&E) procedures.
    

Eligibility criteria:

        Inclusion Criteria:

        A. Age ≥18 years B. Gestational age to be 18 weeks 0 days through 23 weeks 6 days on
        procedure date C. Signed informed procedure consent for dilation and evacuation D. Willing
        to sign informed consent and follow study protocol

        Exclusion Criteria:

        A. Allergy or known intolerance to mifepristone

        B. Known contraindication to mifepristone for cervical preparation prior to dilation and
        evacuation:

          1. Chronic adrenal failure or insufficiency

          2. Concurrent use of long-term corticosteroid therapy

          3. Inherited porphyrias

        C. Any condition that in the opinion of the investigator could impede study participation
        or collection of study data
Cetuximab-IRDye 800CW and Intraoperative Imaging in Finding Pancreatic Cancer in Patients Undergoing Surgery
Condition: Pancreatic Adenocarcinoma
Intervention: Cetuximab-IRDye800; Cetuximab
Intervention description: Administered intravenously (IV) at 50 or 100 mg; Administered as a 100 mg IV loading dose
Intervention MeSH terms: Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      This phase 1-2 trial studies the side effects and best dose of cetuximab-IRDye 800CW when
      used with intraoperative imaging, to determine the utility of cetuximab-IRDye 800CW to
      identify and assess pancreatic cancer in patients undergoing surgery to remove the tumor.
      Cetuximab-IRDye 800CW may help doctors better identify cancer in the operating room by making
      the cancer visible when viewed through a fluorescent imaging system.
    

Eligibility criteria:

        INCLUSION CRITERIA

          -  Clinically suspected or biopsy confirmed diagnosis of pancreatic adenocarcinoma

          -  Planned standard of care surgery with curative intent for pancreatic adenocarcinoma

          -  ≥ 19 years of age

          -  Life expectancy of more than 12 weeks

          -  EITHER

               -  Karnofsky performance status of at least 70%, OR

               -  Eastern Cooperative Oncology Group (ECOG)/Zubrod level 1

          -  Hemoglobin ≥ 9 gm/dL

          -  Platelet count ≥ 100,000/mm^3

          -  Magnesium > the lower limit of normal (LLN) per institution normal lab values

          -  Potassium > LLN

          -  Calcium > LLN

          -  Thyroid-stimulating hormone (TSH) < 13 micro International units/mL

        EXCLUSION CRITERIA

          -  Received an investigational drug within 30 days prior to first dose of cetuximab
             IRDye800

          -  Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive
             heart failure (CHF); or unstable angina within 6 months prior to enrollment

          -  History of infusion reactions to cetuximab or other monoclonal antibody therapies

          -  Pregnant or breastfeeding

          -  Evidence of QT prolongation on pretreatment electrocardiography (ECG) (greater than
             440 ms in males or greater than 450 ms in females)

          -  Lab values that in the opinion of the primary surgeon would prevent surgical resection

          -  Patients receiving class IA (quinidine, procainamide) or class III (dofetilide,
             amiodarone, sotalol) antiarrhythmic agents
A Study of Faricimab (RO6867461) in Participants With Center-Involving Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: Faricimab; Ranibizumab
Intervention description: Faricimab will be administered by IVT injection in the study eye.; Ranibizumab will be administered by IVT injection in the study eye.
Intervention MeSH terms: Ranibizumab; Faricimab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 229.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a multiple-center, multiple-dose, randomized, active comparator-controlled,
      double-masked, three parallel group, 36-week study in participants with center-involving
      diabetic macular edema (DME). Only one eye will be selected as the study eye. Where both eyes
      meet all eligibility criteria, the eye with the worse best corrected visual acuity (BCVA)
      will be defined as the study eye. The study will consist of a treatment period (20 weeks) and
      an observational period (up to 16 weeks). Treatment naive participants will be randomized in
      a 1:1:1 ratio to one of the Arms A, B and C, respectively. Participants previously treated
      with intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) will be randomized in
      a 1:1 ratio to Arms A and C.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Macular edema associated with diabetic retinopathy

          -  Decreased visual acuity attributable primarily to DME

          -  Diagnosis of diabetes mellitus

        Exclusion Criteria:

          -  High risk proliferative diabetic retinopathy

          -  Cataract surgery within 3 months of Baseline, or any other previous intraocular
             surgery

          -  Uncontrolled glaucoma

          -  Current or history of ocular disease in the study eye other than DME

          -  Major illness or major surgical procedure within 1 month prior to Day 1

          -  Uncontrolled blood pressure

          -  Glycosylated hemoglobin (HbA1c) greater than (>) 12 percent (%) at screening

          -  Untreated diabetes mellitus or initiation of oral anti-diabetic medication or insulin
             within 4 months prior to Day 1
Study to Evaluate Safety and Efficacy of Filgotinib and Lanraplenib in Females With Moderately-to-Severely Active Cutaneous Lupus Erythematosus (CLE)
Condition: Cutaneous Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic; Lupus Erythematosus, Cutaneous
Intervention: Lanraplenib; Filgotinib; Lanraplenib placebo; Filgotinib placebo
Intervention description: 30 mg tablets administered orally once daily with or without food; 200 mg tablets administered orally once daily with or without food; Tablets administered orally once daily with or without food; Tablets administered orally once daily with or without food
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 47.0
Sex: Female
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the efficacy of filgotinib and lanraplenib
      (formerly GS-9876) in females with moderately-to-severely active cutaneous lupus
      erythematosus (CLE).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Must have a diagnosis of CLE, either chronic (e.g., discoid) or subacute CLE per
             investigator evaluation, with the following:

               -  Moderately-to-severely active CLE (Cutaneous lupus erythematosus disease area and
                  severity index [CLASI] activity score ≥ 10) at screening and Day 1

               -  Prior intolerance or inadequate response to at least one of the listed
                  medications for the treatment of CLE

          -  Stable dose (defined as no change in prescription for at least 28 days prior to Day 1)
             of antimalarials and/or topical or oral corticosteroids is permitted during the study.
             Individuals who are not planning to continue these medications during the study must
             have discontinued them at least 28 days prior to Day 1

        Key Exclusion Criteria:

          -  Use of prohibited concomitant medications per study protocol

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
E07-001: Safety and Efficacy Extension Study of Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients
Condition: Paroxysmal Nocturnal Hemoglobinuria
MeSH terms: Hemoglobinuria; Hemoglobinuria, Paroxysmal
Intervention: Eculizumab
Intervention description: Each vial contains 30 mL of 10 mg/mL eculizumab; dose of 900 mg intravenous every 14 days.
Intervention MeSH terms: Eculizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Hemolytic Paroxysmal Nocturnal Hemoglobinuria; Eculizumab; PNH

Summary:

      The objective of this study was to assess the long-term safety and efficacy of eculizumab in
      hemolytic PNH patients who completed the 4-week screening and 12-week treatment period of the
      C07-001 study. In addition, pharmacokinetic and pharmacodynamic assessments of eculizumab
      were conducted.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have fully completed C07-001 study 12-week treatment period

        Exclusion Criteria:

          -  Patients who terminated early from the C07-001 study
Efficacy and Safety Study of CD 2027 Spray in Subjects With Plaque-type Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: CD 2027; Calcitriol Vehicle
Intervention description: Participants applied Calcitriol 3 mcg/g spray topically to the affected areas twice daily for 8 weeks.; Participants applied placebo matched to Calcitriol 3 mcg/g spray topically to the affected areas twice daily for 8 weeks.
Intervention MeSH terms: Calcitriol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 88.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: psoriasis; spray; calcitriol

Summary:

      This was a multicenter, randomized, vehicle-controlled, double-blind parallel group study to
      evaluate the efficacy and safety of CD 2027 Oily Spray applied twice daily for 8 weeks in
      participants with plaque-type psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has a diagnosis of plaque-type psoriasis up to 20% of body surface area
             (BSA) involved excluding the scalp, with a Global Severity Score of at least 3
             (moderate) at Screening

          -  Participant presents with a representative target lesion that is at least 16 cm² in
             area, is located on the non-bony areas of the skin, has a Scaling Score up to 2
             (moderate), has a DSS of at least 4

        Exclusion Criteria:

          -  Other type of psoriasis (other than plaque)

          -  Significant abnormal lab findings

          -  Hypercalcemia
Comparison of a Pain Pump Versus Injectable Medication for Analgesia in Knee Arthroscopy
Condition: Pain
Intervention: pain pump containing ropivacaine; saline pain pump with injectable medication; ropivacaine, ketorolac , morphine sulfate
Intervention description: 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour; 30mL of ropivacaine(0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour; 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine; Morphine; Ropivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Hypothesis: Ropivacaine, morphine and ketorolac injected after knee arthroscopy is as
      effective as this solution plus ropivacaine administered intra-articularly for twenty-four
      hours.

      Three groups were assigned random patients, each group provided a different method of pain
      medication in order to determine the effectiveness of each treatment.
    

Eligibility criteria:

        Inclusion Criteria: All subjects who underwent:

          -  knee arthroscopy + synovectomy

          -  knee arthroscopy + partial or complete meniscectomy

          -  knee arthroscopy + chondroplasty

          -  knee arthroscopy + microfracture

          -  knee arthroscopy + autologous osteoarticular transplantation

        Exclusion Criteria:

          -  A surgical procedure that required an incision other then an arthroscopic portal

          -  A surgical procedure within the same joint within ninety days

          -  A acute or chronic knee infection

          -  Any diagnosis of complex regional pain syndrome

          -  A known allergy to one of the study drugs

          -  A documented history of narcotic use

          -  A score of less than two standard deviation on the SF-12 mental component

          -  Any major systemic or cardiac illness (heart failure, uncontrolled angina,
             bifascicular blocks, renal insufficiency, or liver disease)

          -  Under the age of eighteen years
Abatacept in the Treatment of Uveitis
Condition: Uveitis
MeSH terms: Uveitis
Intervention: Abatacept
Intervention description: Subjects will receive approximately 10 mg/kg rounded to the nearest 25 mg for the first 6 months of the trial. At 6 months subjects will then be randomized to receive either 5 mg/kg or 10 mg/kg.
Abatacept will be administered as a 30-minute intravenous infusion. Following the initial administration, abatacept will be given at 2 and 4 weeks after the first infusion and every 4 weeks thereafter for up to 2 years.
Intervention MeSH terms: Abatacept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the safety and efficacy of abatacept in the treatment
      of uveitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients with vision-threatening autoimmune uveitis

          -  failure to respond to prednisone and at least one other systemic immunosuppressive, or
             intolerance to such medications due to side effects

        Exclusion Criteria:

          -  serious concomitant illness that could interfere with the subject's participation