bioihbjkbjnl/mcl2 huggingface dataset:
Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: PF-00547659 SC injection; PF-00547659 SC injection; PF-00547659 SC injection; PF-00547659 SC injection
Intervention description: Placebo delivered SC, 3 doses separated by 4 weeks; Drug dose level 1 delivered SC, 3 doses separated by 4 weeks; Drug dose level 2 delivered SC, 3 doses separated by 4 weeks; Drug dose level 3 delivered SC, 3 doses separated by 4 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 265.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Crohn's disease Safety Efficacy Pharmacokinetics Pharmacodynamics Crohn's Disease Activity Index (CDAI)

Summary:

      Adults with Crohn's disease that is clinically active despite conventional treatment will be
      eligible for this study. Patients may receive one of three doses of PF-00547659 (experimental
      drug) or placebo (inactive drug). Disease activity will be measured every two weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have failed or are intolerant to anti-TNFs and/or immunosuppressants
             (AZA, 6-MP, and/or MTX).

          -  hsCRP greater than 3mg/L

          -  Ulcerations demonstrated by colonoscopy performed during screening or 8 weeks prior to
             screening

        Exclusion Criteria:

          -  Pregnant or breast feeding

          -  Short bowel syndrome due to multiple small bowel resections

          -  Presence of a stoma
Safety and Tolerability of Dabigatran Etexilate in Adolescents
Condition: Venous Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism
Intervention: dabigatran etexilate
Intervention description: 2.14 mg/kg BID to a max 150 mg BID
Intervention MeSH terms: Dabigatran
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      To investigate the safety and tolerability of dabigatran etexilate capsules in a small group
      of eight adolescent patients.
    

Eligibility criteria:

        Inclusion criteria:

          1. males or females 12 to less than 18 years of age

          2. objective diagnosis of primary VTE

          3. completion of planned treatment course with LMWH or OAC for primary VTE

          4. written informed consent by parent (legal guardian) and patient assent

        Exclusion criteria:

          1. weight less than 32 kg

          2. conditions associated with increased risk of bleeding

          3. severe renal dysfunction or requirement for dialysis

          4. active infective endocarditis

          5. hepatic disease

          6. pregnant females or females not using medically accepted contraceptive method

          7. anemia or thrombocytopenia

          8. use of prohibited or restricted drug within previous week

          9. received investigational drug within past 30 days

         10. unreliable patients or patients who have any condition that would not allow safe
             participation in study
Daratumumab in Treating Patients With Multiple Myeloma
Condition: Plasma Cell Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Daratumumab
Intervention description: Given IV
Intervention MeSH terms: Daratumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies the side effects and how well daratumumab works in treating
      patients with multiple myeloma when the infusion is accelerated. Monoclonal antibodies, such
      as daratumumab, may interfere with the ability of tumor cells to grow and spread.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have received >= 2 daratumumab infusions and be scheduled to receive
             another dose

          -  All races and ethnic groups are eligible for this study

          -  Ability to understand and the willingness to sign a written informed consent document

        Exclusion Criteria:

          -  Any other medical condition, including mental illness or substance abuse, deemed by
             the principal investigator to likely interfere with a patient's ability to sign
             informed consent, cooperate and participate in the study, or interfere with the
             interpretation of the results

          -  Concurrent use of complementary or alternative medicines that in the opinion of the
             principal investigator would confound the interpretation of toxicities and/or
             antitumor activity of the study drug

          -  Prisoner
Fondaparinux for the Treatment of Heparin-Induced Thrombocytopenia (HIT)
Condition: Heparin-Induced Thrombocytopenia
MeSH terms: Thrombocytopenia
Intervention: fondaparinux; warfarin
Intervention description: Dosage form: subcutaneous injection; dosage: 7.5 to 10.0 mg; frequency and duration: daily until blood test results rule out confirmed HIT - for patients with confirmed HIT, continue daily until INR (blood clotting) measurement rises to at least 2; Dosage form: oral; dosage: 2.5 to 5.0 mg; frequency and duration: (for confirmed HIT only) once daily, to begin when blood platelet count reaches at least 100,000, and continue for approximately 4 weeks
Intervention MeSH terms: PENTA; Warfarin; Fondaparinux
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: heparin-induced thrombocytopenia; thrombocytopenia; HIT; thrombosis; blood clot; blood thinner; anticoagulant; heparin; warfarin; fondaparinux; Arixtra

Summary:

      The purpose of this study is to determine how safe and effective fondaparinux is in treating
      patients with suspected or confirmed heparin-induced thrombocytopenia (HIT).
    

Eligibility criteria:

        Inclusion Criteria:

          -  high risk for HIT based on "Four Ts score" of 6 or more

        Exclusion Criteria:

          -  pulmonary emboli at the time of enrollment

          -  arterial thrombosis at the time of enrollment

          -  limb threatening phlegmasia cerulea dolens at the time of enrollment

          -  Calculated Creatinin Clearance less than 50 ml/hr

          -  platelet count less than 50

          -  Weight less than 50 kg

          -  pregnancy

          -  allergy to fondaparinux

          -  bacterial endocarditis

          -  history of neuraxial anesthesia and post-operative indwelling epidural catheter

          -  active major bleeding (hemodynamically significant or requiring transfusions)

          -  inability to give informed consent
Carboplatin and Paclitaxel in Elderly Women With Newly Diagnosed Ovarian, Peritoneal, or Fallopian Cancer
Condition: Ovarian Cancer; Primary Peritoneal Carcinoma; Fallopian Tube Cancer; Mixed Tumor, Mesodermal
MeSH terms: Fallopian Tube Neoplasms; Mixed Tumor, Mesodermal
Intervention: Paclitaxel; Carboplatin
Intervention MeSH terms: Paclitaxel; Carboplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: Female
Minimum age: 70 Years
Healthy volunteers: No
Keywords: carboplatin; paclitaxel; elderly women

Summary:

      The main purpose of this trial is to look at how elderly women (70 years of age or older)
      with newly diagnosed ovarian, peritoneal, or fallopian tube cancer manage six cycles of
      carboplatin and paclitaxel, what side effects they experience, and how their cancer reacts or
      responds to standard carboplatin and paclitaxel chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 70 or older

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2 and is
             medically eligible and clinically appropriate to receive systemic chemotherapy

          -  Diagnosis of ovarian, primary peritoneal, fallopian tube cancer, papillary serous
             cancer of the endometrium, or mixed mesodermal tumors of the ovary, fallopian tube or
             uterus

          -  Life expectancy greater than 6 months

          -  Baseline laboratory values as described in protocol

        Exclusion Criteria:

          -  Active infection requiring antibiotics at the time of starting chemotherapy

          -  Prior pelvic radiotherapy > 25% of bone marrow

          -  Any uncontrolled medical problem that in the opinion of the investigator would
             preclude safe administration of the study drugs

          -  Past history of bone marrow transplantation or stem cell support

          -  Known history of central nervous system (CNS) metastasis

          -  History of prior malignancy that required prior systemic therapy

          -  Clinically significant cardiac disease

          -  Uncontrolled diabetes mellitus

          -  Any signs of intestinal obstruction

          -  Participation in an investigational drug study within three weeks prior to study entry

          -  History of psychiatric disability or other central nervous system disorder
A Study of a New Drug Treatment for Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: 1.2% JNJ 10229570-AAA; 2.4% JNJ 10229570-AAA; 3.6% JNJ 10229570-AAA; Vehicle control
Intervention description: 1.2% JNJ 10229570-AAA 1.2% cream applied once daily to the face for 12 weeks; 2.4% JNJ 10229570-AAA 2.4% cream applied once daily to the face for 12 weeks; 3.6% JNJ 10229570-AAA 3.6% cream applied once daily to the face for 12 weeks; Color matched cream vehicle, applied once daily to the face for 12 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 431.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Acne; Irritation; Safety; Sebum

Summary:

      A study to determine if three different doses of a new acne treatment are safe and better at
      reducing facial acne than a treatment without active ingredient.
    

Eligibility criteria:

        Inclusion Criteria:

          -  12 years of age or older, with moderate facial acne vulgaris as defined in the
             protocol

          -  If female of childbearing potential, must take a pregnancy test and have a negative
             result

          -  Females of childbearing potential must also agree to use an adequate method of birth
             control, which would include:

               -  systemic birth control (Subjects must have been taking the same type of birth
                  control for at least 3 months prior to entering the study and must not change
                  type of birth control during the study)

               -  Condom with spermicide

               -  IUD. Females who have had a hysterectomy, bilateral oophorectomy or bilateral
                  tubal ligation are not required to use additional birth control methods

        Exclusion Criteria:

          -  Known sensitivity to any of the ingredients in the study medication

          -  More than 3 nodulocystic acne lesions

          -  Use of acne treatments, therapies or medications within protocol-specified timeframes

          -  Presence of other skin conditions, diseases, or medical conditions that (per protocol
             or in the opinion of the investigator) may require concurrent therapy, interfere with
             the evaluation of the study medication, or compromise subject safety

          -  Excessive facial hair that may interfere with application of the medication and/or
             evaluations
A Pilot Study of Effects of Exenatide on Body Weight in Non-Diabetic, Obese Patients
Condition: Obesity
MeSH terms: Body Weight
Intervention: exenatide; placebo
Intervention description: subcutaneous injection (5mcg or 10mcg), twice a day; subcutaneous injection (equivalent volume to active dose), twice a day
Intervention MeSH terms: Exenatide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 163.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: exenatide; obesity; diabetes; Amylin; Lilly

Summary:

      This is a multicenter study designed to compare the effect of exenatide plus a lifestyle
      modification plan versus placebo plus a lifestyle modification plan on weight loss in
      non-diabetic, obese subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a Body Mass Index (BMI) >= 30kg/m^2

        Exclusion Criteria:

          -  Have ever participated in this study previously, or any other study using exenatide
             (AC2993/LY2148568) or GLP-1 analogs

          -  Have participated in an interventional medical, surgical, or pharmaceutical study (a
             study in which an experimental, drug, medical, or surgical treatment was given) within
             30 days of study start (this criterion includes drugs that have not received
             regulatory approval for any indication at the time of study entry)

          -  Diagnosis of diabetes mellitus (other than gestational diabetes), or previous use of
             anti-diabetic medications for > 3 months

          -  Have had a change in prescribed lipid-lowering or blood pressure agents within 4 weeks
             of screening

          -  Used drugs for weight loss (e.g., Xenical [orlistat], Meridia [sibutramine], Acutrim
             [phenylpropanolamine], Accomplia [rimonabant], Alli [low-dose orlistat], or other
             similar over-the-counter weight loss remedies or medications) within 3 months of
             screening

          -  Are actively participating in, or have participated in a formal weight loss program
             within the last 3 months

          -  Have a history of chronic use of drugs that directly affect gastrointestinal motility,
             including, but not limited to Reglan (metoclopramide) and chronic macrolide
             antibiotics

          -  Have been treated with any anti-diabetic medications within 3 months of screening

          -  Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy or
             have received such therapy within the 4 weeks immediately prior to study start

          -  Have had bariatric surgery

          -  Have had an organ transplant
Double Blind Study to Evaluate the Efficacy of Collagenase Histolyticum in the Treatment of Lipoma
Condition: Lipoma
MeSH terms: Lipoma
Intervention: AA4500; placebo
Intervention description: Subjects must present with 2 lipomas; one to receive AA4500 and one to receive placebo simultaneously; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine whether collagenase is effective in reducing the
      surface area of a subcutaneous benign lipoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18-75 years of age, of either sex or any race

          -  Clinical history of at least 2 lipomas for at least one year

          -  Lipomas diagnosed as benign

          -  Two lipomas on distinctly separate parts of the body, or on the torso if 30 cm apart,
             with easily definable edges

          -  Each lipoma is a single mass with easily definable edges

          -  Lipomas are 5 to 24 cm squared

          -  Women of childbearing potential must use an acceptable method of birth control

        Exclusion Criteria:

          -  Lipomas on the head, neck, hand or foot, or female breast

          -  Women who are nursing or pregnant

          -  Multi-lobular lipomas

          -  Subjects who have received an investigational drug within 30 days before receiving the
             first dose of study drug in this study

          -  Subjects with a known allergy to collagenase or any of the inactive ingredients in
             XIAFLEX

          -  Subjects with uncontrolled diabetes, hypertension, or thyroid disease, or any medical
             condition that would make the subject unsuitable for enrollment

          -  Subjects having prior treatment or trauma of the lipoma that could interfere with
             study assessments

          -  Subjects with a history of connective tissue diseases, rheumatological diseases

          -  Subjects taking anticoagulants or planning to receive anticoagulants (except for lo
             dose aspirin and over-the-counter nonsteroidal anti-inflammatory drugs) within 7 days
             of injection of study drug
A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in a Healthy Pediatric Population in the USA
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: CSL's 2009 H1N1 Influenza Vaccine (CSL425); CSL's 2009 H1N1 Influenza Vaccine (CSL425); Placebo
Intervention description: 0.5 mL intramuscular injection on Day 0 and Day 21; 0.25 mL intramuscular injection on Day 0 and Day 21; Placebo
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 473.0
Sex: All
Minimum age: 6 Months
Maximum age: 9 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the immunogenicity and safety profile of CSL425
      (CSL's 2009 H1N1 influenza vaccine) in a healthy pediatric population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female aged >= 6 months to < 9 years at the time of the first study
             vaccination.

          -  For children < 3 years of age at the time of first vaccination, born at or after 36
             weeks gestation.

        Exclusion Criteria:

          -  Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to
             eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccine
A Study to Assess Immune Response Following Zoster Vaccination to Subjects With Rheumatoid Arthritis Receiving Tofacitinib or Placebo With Background Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Tofacitinib; Placebo
Intervention description: 5 mg twice daily of tofacitinib with background methotrexate for 12 weeks; Placebo tablets twice daily with background methotrexate for 12 weeks
Intervention MeSH terms: Tofacitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 112.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This study will evaluate immune response following administration of zoster vaccine in
      subjects with rheumatoid arthritis who are receiving background methotrexate and initiate 5
      mg twice daily of tofacitinib or placebo for tofacitinib 2 to 3 weeks following vaccination.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have moderate to severe rheumatoid arthritis inadequately controlled by
             methotrexate as defined by the American College of Rheumatology (ACR) classification
             criteria for Rheumatoid arthritis, painful and swollen joint counts and C-reactive
             protein (CRP).

          -  Screening CRP >3 mg/L or CDAI score > 10 at screening or at baseline before
             vaccination.

          -  Subjects must have active disease at screening and baseline.

          -  Must be at least 50 years of age or older.

        Exclusion Criteria:

          -  History of receiving any varicella-zoster virus vaccine

          -  Receipt of any vaccines within 6 weeks of first dose of study treatment.

          -  Subjects with current infections or history of infections.

          -  History of recurrent (more than one episode) of herpes zoster or disseminated (a
             single episode) of herpes zoster or disseminated (a single episode) of herpes simplex.
ACP-196 Versus Placebo in Subjects With Rheumatoid Arthritis on Background Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: acalabrutinib; Placebo
Intervention MeSH terms: Methotrexate; Acalabrutinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Acalabrutinib

Summary:

      This study is evaluating the safety, pharmacokinetics (PK), pharmacodynamics (PD) and
      efficacy of ACP-196 in subjects with Rheumatoid Arthritis on background Methotrexate.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Diagnosis of RA according to the 2010 ACR/EULAR Classification Criteria .

          -  Must be on a stable MTX dose (7.5 to 25 mg/week)

          -  Subjects must be able to read and understand the consent form, complete the
             study-related procedures, and communicate with the study staff.

          -  Are willing and able to adhere to the study visit schedule, and understand and comply
             with other protocol requirements.

        Main Exclusion Criteria:

          -  Prior malignancy, except for adequately treated basal cell or squamous cell skin
             cancer, in situ cervical cancer, or other cancer from which the subject has been
             disease free for ≥ 5 years.

          -  A life-threatening illness, medical condition or organ system dysfunction which, in
             the investigator's opinion, could compromise the subject's safety, interfere with the
             absorption or metabolism of ACP-196, or put the study outcomes at undue risk.

          -  Subjects who have taken any investigational drug within the previous 30 days before
             randomization.

          -  Use of all other synthetic disease-modifying antirheumatic drugs (DMARDS) such as but
             not limited to leflunomide, azathioprine, cyclosporine, penicillamine or gold salts
             within 8 weeks of randomization.

          -  Use of etanercept, anakinra, tofacitinib within 4 weeks of randomization.

          -  Use of abatacept, humira, infliximab, or tocilizumab within 8 weeks of randomization.