bioihbjkbjnl/mcl2 huggingface dataset:
Study of the Efficacy and Safety of MEDI4893
Condition: Staphylococcus Aureus Pneumonia
MeSH terms: Pneumonia, Staphylococcal
Intervention: MEDI4893; Placebo
Intervention description: Participants will receive a single IV dose of MEDI4893 2000 or 5000 mg on Day 1 of the study.; Participants will receive a single IV dose of placebo matched to MEDI4893 on Day 1 of the study.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 213.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No

Summary:

      Clinical trial looking at safety and efficacy of MEDI4893 in prevention of pneumonia caused
      by Staphylococcus aureus in high-risk patients
    

Eligibility criteria:

        Inclusion Criteria:

          -  Colonized with Staphylococcus aureus, expected to require prolonged intubation and
             mechanical ventilation, without any evidence of active pneumonia.

        Exclusion Criteria:

          -  Staphylococcal disease at randomisation; lung injury score consistent with pneumonia;
             current lung disease; chronic tracheostomy patients; currently receiving systemic
             anti-staphylococcal antibiotics; moribund patients.
Measure Liver Fat Content After ISIS 301012 (Mipomersen) Administration
Condition: Lipid Metabolism, Inborn Errors; Hyperlipidemias; Metabolic Diseases; Hypolipoproteinemia; Hypolipoproteinemias; Hypobetalipoproteinemias; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Infant, Newborn, Diseases; Congenital Abnormalities; Metabolic Disorder; Hypercholesterolemia; Dyslipidemias; Lipid Metabolism Disorders
MeSH terms: Congenital Abnormalities; Genetic Diseases, Inborn; Infant, Newborn, Diseases; Metabolism, Inborn Errors; Lipid Metabolism, Inborn Errors; Hypobetalipoproteinemias; Hypolipoproteinemias; Hypercholesterolemia; Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias; Metabolic Diseases; Lipid Metabolism Disorders
Intervention: mipomersen; Placebo
Intervention description: 200 mg subcutaneous injections; subcutaneous injections
Intervention MeSH terms: Mipomersen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: LDL-cholesterol; apoB-100; apoB-48; triglyceride; HeFH; FHBL

Summary:

      This study will assess what, if any, effect that ISIS 301012 (mipomersen) has on liver
      triglyceride content in multiple groups of subjects with varying degrees of risk for hepatic
      steatosis. In order to enroll subject groups with varying degrees of risk, the study has
      included multiple cohorts (Cohorts A-G). Additions and removal of cohorts has been
      accomplished with protocol amendments.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Group A - are healthy subjects

          -  Group D - has impaired fasting glucose and mixed dyslipidemia

          -  Group E - has a diagnosis of Heterozygous Familial Hypercholesterolemia (HeFH) and on
             stable lipid-lowering therapy for 3 months

          -  Group F - has a diagnosis of Familial Hypobetalipoproteinemia (FHBL)

          -  Group G - has a diagnosis of Diabetes and hypercholesterolemia

        Exclusion Criteria:

          -  Medical, surgical, laboratory or other conditions which in the judgment of the
             Physician Investigator would make the subject unsuitable for enrollment, or
             potentially interfere with subject participation or completion of the study.
Safety and Efficacy of Cariprazine as an Adjunctive to Antidepressant Therapy in Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Placebo; Cariprazine
Intervention description: Placebo was supplied in capsules; Cariprazine was supplied in capsules.
Intervention MeSH terms: Cariprazine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 819.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Major depressive disorder; Depression

Summary:

      An outpatient study to evaluate the safety and efficacy of cariprazine as adjunct to
      antidepressant therapy (ADT) in participants with major depressive disorder (MDD) who have an
      inadequate response to ADT alone. This clinical study compared cariprazine + ADT with placebo
      + ADT in outpatients with a diagnosis of MDD and an inadequate response to ADT. The study
      consisted of approximately 2 weeks of screening and washout followed by 8 weeks of
      double-blind treatment followed by a 1 week safety follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female outpatients 18 to 65 years of age, inclusive.

          -  Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth
             Edition, Text Revision (DSM-IV-TR) criteria for moderate to severe major depressive
             disorder (MDD).

          -  Current major depressive episode of at least 8 weeks and not exceeding 24 months in
             duration.

          -  Ongoing inadequate response to protocol allowed antidepressant therapy (ADT).

        Exclusion Criteria:

          -  Principal DSM-IV-TR-based diagnosis of an axis I disorder, other than MDD,

          -  Women who are pregnant, or planning to become pregnant or breastfeed during the study
             or not practicing reliable contraception that will continue through out the study.

          -  History of meeting DSM-IV-TR criteria for:

               1. Depressive episode with psychotic or catatonic features.

               2. Manic, hypomanic or mixed episode, including bipolar disorder and substance
                  induced manic, hypomanic or mixed episode.

               3. Schizophrenia, schizoaffective, or other psychotic disorder.

               4. Obsessive-compulsive disorder.

               5. Bulimia or anorexia nervosa.

               6. Dementia, amnesic, or other cognitive disorder.

               7. Mental retardation.

          -  Participants considered a suicide risk.
Hydrocodone/Acetaminophen for Acute Pain Following Third Molar Tooth Extraction
Condition: Pain
MeSH terms: Acute Pain
Intervention: ABT-712 Extended-release; Hydrocodone/Acetaminophen Immediate-release; Placebo
Intervention description: ABT-712 extended-release tablet; Hydrocodone/acetaminophen immediate-release tablet; Placebo tablet
Intervention MeSH terms: Acetaminophen; Acetaminophen, hydrocodone drug combination; Hydrocodone; Oxycodone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to evaluate analgesic efficacy and safety of
      hydrocodone/acetaminophen compared to placebo in moderate to severe pain following molar
      extraction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who are in general good health, experiencing moderate to severe pain after
             surgical extraction of 2 or more third molars and who are willing to remain confined
             until the morning after surgery for study procedures

        Exclusion Criteria:

          -  Allergies to study medications

          -  History of multiple drug allergies

          -  Unable to stop excluded medications

          -  Clinically significant laboratory abnormalities at Screening

          -  Significant medical condition at Screening

          -  Women who are pregnant or breast feeding
A Phase 2b Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Active Non-segmental Vitiligo Subjects
Condition: Active Non-segmental Vitiligo
MeSH terms: Vitiligo
Intervention: PF-06651600; PF-06651600; PF-06651600; PF-06651600; PF-06651600; placebo; PF06700841; narrow-band UVB phototherapy
Intervention description: Induction dose 1. Oral tablet taken QD; Induction dose 2. Oral tablet taken QD; Maintenance dose A. Oral tablet taken QD; Maintenance Dose B. Oral tablet taken QD; Maintenance Dose C. Oral tablet taken QD; placebo; Oral tablet taken QD; Phototherapy will be combined with PF-06651600
Intervention MeSH terms: PF-06700841
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Dose ranging period is a parallel design. Extension period is a sequential design.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Dose ranging period is blinded. The partially blinded extension period includes open arms and blinded arms.
Enrollment: 366.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a Phase 2b, randomized, double blind, parallel group, multicenter study with an
      extension period. The study will have a maximum duration of approximately 60 weeks. This
      includes an up to 4 weeks Screening Period, a 24 week dose ranging period, an up to 24 week
      extension period and a 8 week Follow up Period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects between 18-65 years of age, inclusive, at time of informed
             consent.

          -  Must have moderate to severe active non-segmental vitiligo.

        Exclusion Criteria:

          -  History of human immunodeficiency virus (HIV) or positive HIV serology at screening,

          -  Infected with hepatitis B or hepatitis C viruses.

          -  Have evidence of active or latent or inadequately treated infection with Mycobacterium
             tuberculosis (TB)
Investigating FE 202158 as Potential Primary Treatment in Patients With Early Septic Shock
Condition: Septic Shock
MeSH terms: Shock, Septic; Shock
Intervention: FE 202158
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this trial is to investigate the potential of FE 202158 as a treatment which
      can stabilize blood pressure for treatment of patients in early septic shock.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent form by the patient or a legal representative according to
             local regulations'

          -  Man or women 18 years of age or older

          -  Body weight below 115 kg for male patients and 100 kg for female patients

          -  Proven or suspected infection

          -  Septic shock, i.e. vasodilatory hypotension requiring vasopressor support

          -  Willing to use an adequate barrier method or hormonal method of contraception, if not
             abstinent, from informed consent to one week after the end of infusion of study
             medication

        Exclusion Criteria:

          -  Present or a history within the last 6 months of symptoms of acute coronary syndrome
             (myocardial infarction or unstable angina)

          -  Known or suspected endocarditis

          -  Hypovolaemia suspected on clinical grounds, e.g. cold extremities with delayed
             capillary filling, low cardiac filling pressure, marked systolic or pulse pressure
             variation or positive leg raising test

          -  Known or suspected cardiac failure

          -  Known or suspected infection with (HIV)-1, HIV-2, hepatitis B, or hepatitis C

          -  Pregnancy or breastfeeding

          -  Any cause of hypotension other than early septic shock

          -  Use of vasopressin or terlipressin within 7 days prior to start of IMP infusion

          -  Proven or suspected acute mesenteric ischemia, as judged by the investigator

          -  Known episode of septic shock within 1 month prior to screening

          -  Death anticipated within 24 hours, or due to the underlying disease within 3 months

          -  Known past or current 2nd and 3rd degree AV-block without a well functioning pacemaker

          -  Brain injury within current hospitalisation

          -  Present hospitalisation with burn injury

          -  Symptomatic peripheral vascular disease including Raynaud's syndrome

          -  Previously included in this trial

          -  Intake of an Investigational Medicinal Product (IMP) within the last 3 months (or
             longer if judged by the Investigator to possibly influence the outcome of the current
             study)

          -  Known participation in another interventional clinical trial

          -  Considered by the investigator to be unsuitable to participate in the trial for any
             other reason
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) When Given Together With ABT-333 and Ribavirin (RBV) in Treatment-Naïve and Non-responder Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
Condition: Chronic Hepatitis C Infection; Hepatitis C; Hepatitis C Virus
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: ABT-450; ABT-333; ribavirin; ritonavir
Intervention description: tablets; tablets; tablets; capsules
Intervention MeSH terms: Ritonavir; Ribavirin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the antiviral activity, safety, and pharmacokinetics
      of ABT-450 with ritonavir (ABT-450/r) dosed in combination with ABT-333 (also known as
      dasabuvir) and ribavirin (RBV) in treatment-naïve and non responder participants with
      genotype 1 chronic hepatitis C virus (HCV) infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic hepatitis C virus (HCV)

          -  Treatment naive, null or partial responders to previous treatment with peginterferon
             and ribavirin

          -  Males and females 18-65 years old

          -  Body mass index 18 to < 35 kg/m^2

          -  Females must be postmenopausal for at least 2 years or surgically sterile

        Exclusion Criteria:

          -  Cirrhosis or extensive bridging fibrosis

          -  History of cardiac disease

          -  Positive screen for certain drugs or alcohol

          -  Abnormal laboratory results

          -  Significant sensitivity to any drug

          -  Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody

          -  Use of strong cytochrome P450 3A (CYP3A), cytochrome P450 2C8 (CYP2C8), and organic
             anion transporting polypeptide 1B1 (OATP1B1) enzyme inducers or inhibitors within 1
             month of dosing
Nitrite Infusion in Islet Cell Transplantation
Condition: Diabetes
Intervention: Control; Pre-Isolation Infusion; Post-Isolation Infusion
Intervention description: A saline infusion will be administered during the pre-isolation and post-isolation phases.; A nitrite infusion will be administered during the pre-isolation phase and a saline infusion will be administered during the post-isolation phase.; A saline infusion will be administered during the pre-isolation phase and a nitrite infusion will be administered during the reperfusion phase.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetes; Insulin Resistance; Nitrite; Pancreatic islet cells; Autotransplantation; Ischemia reperfusion injury; Mitigation; Cure; Nitric oxide; Sodium nitrite; Islet cell; Survival; Pancreas; Liver

Summary:

      This study seeks to investigate the effects of administering nitrite to pancreatic islet
      cells that have been removed from a patient for autotransplantation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients greater than or equal to 18 years of age

          -  Scheduled to undergo Islet Cell auto-transplantation by Dr. Jared White or Dr. Bart
             Rose

          -  Subjects who can provide informed written consent and are willing to do so

        Exclusion Criteria:

        -Any patient with liver disease or unsuitable for surgery (as determined by the surgeon)
Ibritumomab Tiuxetan (Zevalin)+ Rituximab Maintenance
Condition: Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: Ibritumomab Tiuxetan (Zevalin) + Rituximab
Intervention description: Subjects will receive the Ibritumomab Tiuxetan (Zevalin) therapeutic regimen; then rituximab consolidation and maintenance therapy every 3 months until disease progression
Intervention MeSH terms: Rituximab; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Zevalin, High Tumor Burden Indolent Non-Hodgkin's Lymphoma, Ibritumomab Tiuxetan

Summary:

      Subjects will receive the Ibritumomab Tiuxetan (Zevalin) therapeutic regimen; then rituximab
      consolidation and maintenance therapy every 3 months until disease progression
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with biopsy-proven non-hodgkins lymphoma of follicular grade 1, 2, or 3

          -  Meeting FLIPI criteria for intermediate or high risk.

          -  No prior chemotherapy, radiotherapy or immunotherapy for lymphoma;

          -  Patients may not have known HIV infection, and must not be Hepatitis B Surface Antigen
             positive.

        Exclusion Criteria:

          -  May not be pregnant or breastfeeding, have documented CNS (Central Nervous System)
             disease, G-CSF (Granulocyte Colony Stimulating Facto) or GM-CSF
             (Granulocyte/Macrophage Colony Stimulating Factor) within 2 weeks prior
A Dose-finding Study of OPC-6535 in Patients With Active Ulcerative Colitis
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: OPC-6535(Tetomilast)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: OPC-6535; ulcerative colitis

Summary:

      The purpose of this study is to examine the safety and efficacy of OPC-6535 (tetomilast) and
      to determine its optimal dose by once-daily oral administration at 0, 12.5, 25, or 50 mg for
      8 weeks in combination with a fixed oral dose of 5-aminosalicylic acid (5-ASA) in patients
      with active ulcerative colitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with active ulcerative colitis

          -  Patients who have been receiving an oral 5-ASA formulation at a fixed regimen and at a
             fixed dose

          -  Either inpatient or outpatient

        Exclusion Criteria:

          -  Patients who have a history of intestinal resection (other than appendiceal resection)

          -  Patients who have a complication of malignant tumor

          -  Female patients who are pregnant, lactating, or possibly pregnant, or who wish to
             become pregnant during the study period
Pharmacokinetics and Tolerability Study of Risperidone ISM® in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Risperidone ISM
Intervention description: Four doses of 75 mg of Risperidone ISM as intramuscular (IM) injection into the deltoid muscle at 28-day intervals.
Four doses of 75 mg of Risperidone ISM as intramuscular injections into the gluteal muscle at 28-day intervals.
Intervention MeSH terms: Risperidone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      To characterize the pharmacokinetics (PK) of the injectable intramuscular (IM) long-acting
      formulation (in situ microparticle, ISM) of risperidone over four IM injections in the
      gluteal and deltoid muscle at 28-day intervals and at one dose strength (75 mg) in patients
      with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Capable of providing informed consent.

          2. Male or female aged ≥18 years to ≤65 years.

          3. Current diagnosis of schizophrenia, according to Diagnostic and Statistical Manual

          4. Body mass index (BMI) ≥17 kg/m2 but ≤35 kg/m2.

          5. Medically stable over the last month, and psychiatrically stable

          6. On oral stable dosage of risperidone ≥4 mg daily as maintenance therapy.

          7. Total score ≤70 on the Positive and Negative Syndrome Scale.

          8. Using a medically accepted contraceptive method

          9. Agrees to washout all prohibited medications prior to baseline (day -1)

        Exclusion Criteria:

          1. Informed consent obtained from a third party.

          2. Prisoners or patients who are compulsorily detained.

          3. Females who are breast-feeding and/or who have a positive pregnancy test.

          4. Presence of an uncontrolled, unstable clinically significant medical condition.

          5. Positive serology for Hepatitis B, Hepatitis C or anti-HIV 1 and 2 at screening.

          6. History of neuroleptic malignant syndrome.

          7. Current or past history of tardive dyskinesia.

          8. Positive urine drug or alcohol screen finding.

          9. Risk of committing self-harm or harm based on Columbia Suicidal Rating Scale.

         10. Taking more than one antidepressant.

         11. Use of depot antipsychotics within the last three months.

         12. Use of strong or moderate cytochrome P450 isoenzyme 3A4inducers

         13. Use of electroconvulsive therapy (ECT) within the last three months.

         14. Receipt of any investigational drugs within the last three months.

         15. Known or suspected allergy or hypersensitivity to risperidone

         16. Previous non-responder to risperidone treatment.