bioihbjkbjnl/mcl2 huggingface dataset:
Extension Study to Assess the Efficacy and Safety of Repeat Treatment With Rituximab (MabThera) in Participants With Active Rheumatoid Arthritis (RA)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Rituximab; Methotrexate; Methylprednisolone; Folic Acid
Intervention description: Participants will receive rituximab 1 gram IV on Days 1 and 15 of each course of retreatment.; Participants will receive methotrexate 10-25 mg/week orally or parenterally.; Participants will receive methylprednisolone 100 mg IV 30 minutes prior to each rituximab infusion.; Participants will receive folic acid >= 5 mg/week or equivalent.
Intervention MeSH terms: Folic Acid; Methylprednisolone; Rituximab; Methotrexate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 465.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      This study will assess the long-term safety and efficacy of repeat treatment courses of
      rituximab, in combination with methotrexate in a disease-modifying anti-rheumatic drug
      (DMARD) inadequate responder population of participants who were previously randomized into
      studies WA16291 (NCT02693210) or WA17043/U2644g (NCT00074438). The study permits multiple
      re-treatments until the protocol-defined end-of-treatment date (31 December 2011).
      Participants will then enter a safety follow-up (SFU) period of at least 48 weeks. This will
      provide at least 7 years follow-up data on all participants initially randomized into WA16291
      or WA17043/U2644g. Approximately 600 participants will potentially be eligible to enter this
      open label extension study from their respective feeder studies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  participants with active RA

          -  completed 24 weeks of treatment in WA16291 or WA17043

          -  eligible for re-treatment, based on clinical symptoms (Disease Activity Score in 28
             joints >=2.6)

          -  females of childbearing potential using reliable contraception

        Exclusion Criteria:

          -  participants who participated in rituximab studies WA16291 or WA17043 but withdrew
             into the safety follow-up phases of these trials

          -  previous rituximab non-responders

          -  current treatment with any other disease-modifying drug (apart from methotrexate), or
             any anti-tumor necrosis factor alfa, anti-interleukin-1, or other biologic therapies

          -  participants with known active infection of any kind

          -  evidence of any new or uncontrolled concomitant disease or development of any new
             contraindications which would preclude repeat treatment with rituximab

          -  history of severe allergic or anaphylactic reactions to humanized or murine monoclonal
             antibodies

          -  female participants who are pregnant or breastfeeding
Proof of Concept Study Concerning Efficacy of P03277 MR Imaging in HCC Diagnosis
Condition: Chronic Liver Disease; HepatoCellular Carcinoma
MeSH terms: Liver Diseases
Intervention: P03277 at 0.1 mmol/kg; P03277 at 0.05 mmol/kg
Intervention description: P03277 will be administered at 0.1 mmol/kg BW (corresponding to 0.2 mL/kg BW) by intravenous (IV) bolus injection at 2 mL/s rate without dilution, followed by a 0.9% saline flush.; P03277 will be administered at 0.05 mmol/kg BW (corresponding to 0.1 mL/kg BW) by intravenous (IV) bolus injection at 2 mL/s rate without dilution, followed by a 0.9% saline flush.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is an exploratory study aiming to collect data about diagnosis efficacy
      (sensitivity and specificity) of P03277 triphasic liver imaging for HCC in subjects with
      suspected small nodules and chronic liver disease. 30 subjects will be included, having HCC
      confirmed or not by previous enhanced CT and/or MRI and before any biopsy for histology
      analysis. The standard of reference for diagnosis will be given by the site according to
      their standard of care and adapted from EASL/EORTC diagnostic criteria (considering previous
      contrast enhanced imaging (CT and/or MRI) and/or biopsy specimen analysis given on-site
      and/or the more recent AFP results available). 10 additional subjects will be included to
      explore the diagnostic efficacy for HCC at half dose of P03277.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject presenting with liver cirrhosis or chronic liver disease as shown by previous
             liver biopsy or by combination of clinical, endoscopic, biological, ultrasound
             parameters, and elastography

          -  Subject presenting with 1 to a maximum of 3 untreated hepatic nodule(s) of less than
             or equal to 3 cm (long axis) previously identified and/or characterized through
             enhanced CT and/or MRI within a maximum of 21 days before P03277 imaging, confirmed
             for HCC or not

        Exclusion Criteria:

          -  Subject presenting with hepatic nodule more than 3 cm in addition to nodule(s) less
             than or equal to 3 cm

          -  Subject already treated for HCC by surgery or thermal ablation for which the resection
             or coagulation area is less than 2 cm from the new nodule(s)

          -  Subject previously treated by transarterial chemoembolization

          -  Subject with moderate or severe renal impairment (eGFR < 60 mL/min/1.73 m2) based on
             measurement done or available within the 7 days before P03277 administration and
             assessed after any iodinated contrast agent administration, or with dialysis end stage
             renal disease (ESRD)
Magnesium Supplementation for the Prevention of Supraventricular Arrhythmias
Condition: Premature Atrial Contraction
MeSH terms: Arrhythmias, Cardiac; Atrial Premature Complexes
Intervention: Oral Magnesium Supplement; Placebo
Intervention description: 400 mg Magnesium Citrate 1x daily for 12 weeks; Placebo pill resembling 400 mg Magnesium Citrate 1x daily for 12 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 59.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Magnesium Supplementation; Magnesium; Dietary Supplement; Arrhythmia

Summary:

      The primary objective of this research is to determine whether oral magnesium supplementation
      in healthy, community-living individuals will be associated with reductions in the burden of
      arrhythmias in the upper chambers of the heart (supraventricular arrhythmias).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 55 and older

          -  Ability to speak English

          -  Availability to attend baseline and follow-up visit approximately 12 weeks after
             baseline

        Exclusion Criteria:

          -  Prior history of heart disease (coronary heart disease, heart failure, atrial
             fibrillation), stroke, severe renal disease

          -  Use of type I and III antiarrhythmics or digoxin

          -  Current use of magnesium supplements

          -  Any prior history of allergy or intolerance to magnesium

          -  Prior history of inflammatory bowel disease or any severe gastrointestinal disorder
Free Venlafaxine Treatment for Marijuana Addiction and Depression - 1
Condition: Depression; Marijuana Abuse
MeSH terms: Marijuana Abuse; Depression; Depressive Disorder
Intervention: Venlafaxine; Placebo
Intervention description: 375mg/day; Placebo
Intervention MeSH terms: Venlafaxine Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 123.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: cannabis dependence; depression; treatment; venlafaxine

Summary:

      The purpose of this study is to determine if Venlafaxine Extended Release (Ven-XR) is
      effective in treating individuals with marijuana addiction and depression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets criteria for current marijuana addiction and reports marijuana as primary drug
             of abuse

          -  Currently meets criteria for major depression or dysthymic disorder and receive a
             score of greater than or equal to 12 on the Hamilton Depression Inventory

          -  Clinically depressed for at least 3 months during a period of active marijuana use

          -  Women of child-bearing age will be included provided that they are not pregnant, based
             on the results of a blood pregnancy done at the time of screening and agree to use a
             method of contraception with proven efficacy and not to become pregnant during the
             study. To confirm this, blood pregnancy tests will be repeated monthly. Women will be
             provided a full explanation of the potential dangers of pregnancy while on the study.
             If a woman becomes pregnant, the study medication will be discontinued.

        Exclusion Criteria:

          -  Meets criteria for past manic or psychotic disorder, unless substance-related

          -  History of a seizure disorder

          -  Individuals with chronic organic mental syndrome

          -  Any significant risk for suicide based on current assessment and history of attempts

          -  History of allergic reaction to either Venlafaxine or Ven-XR

          -  Unstable physical disorders that might make participation hazardous, such as
             uncontrolled hypertension and tachycardia (SBP>150, DBP >90, or a sitting quietly
             HR>100), acute hepatitis (patients with chronic mildly elevated transaminase levels
             (<2x upper limit of normal are acceptable) or unstable diabetes

          -  History of failure to respond to a previous adequate trial of Venlafaxine of at least
             300 mg. for at least a 6-week period

          -  Physical dependence on any other drugs (excluding nicotine) that would require medical
             detoxification

          -  Currently being prescribed psychotropic medication by another physician (in the last 3
             weeks), except for acute treatment of insomnia.

          -  Pregnant or breast-feeding
Efficacy Study of Gemcitabine-Paclitaxel to Treat Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: gemcitabine; paclitaxel
Intervention description: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression; 175 mg/m2, intravenous (IV), every 21 days until disease progression
Intervention MeSH terms: Paclitaxel; Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the response rate to a gemcitabine-paclitaxel
      combination administered on a 3-weekly schedule in Chinese patients with unresectable,
      locally recurrent breast cancer or metastatic breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female patients of Chinese origin with histologically or cytologically proven
             diagnosis of breast cancer.

          -  Unresectable, locally recurrent breast cancer or stage IV disease.

          -  Have at least one measurable lesion as defined by Response Evaluation Criteria In
             Solid Tumors (RECIST) criteria.

          -  Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Scale

          -  Treatment with an anthracycline-based chemotherapy regimen in the adjuvant/neoadjuvant
             setting with subsequent disease relapse.

        Exclusion Criteria:

          -  Prior chemotherapy for unresectable, locally advanced breast cancer or metastatic
             disease.

          -  Concurrent administration of any other tumor therapy, including cytotoxic
             chemotherapy, hormonal therapy, and immunotherapy.

          -  Known or suspected brain metastasis or second primary malignancy that is clinically
             detectable at the time of consideration for study enrollment.

          -  Active infection or other serious condition.

          -  Pregnant or breastfeeding.
Biomarkers in Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: D Serine; Placebo
Intervention description: 60 mg/kg/day; oral
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: biomarker; EEG; schizophrenia; NMDA; D-serine

Summary:

      N-methyl-D-aspartate (NMDA)-type glutamate receptors are thought to play a pivotal role in
      neurocognitive dysfunction associated with schizophrenia. Further, several novel
      glutamate-based classes of compound are presently in development as potential novel
      treatments for persistent negative and cognitive symptoms. The study will assess
      effectiveness of a NMDA-based intervention on biomarkers related to schizophrenia as a
      mechanism for developing appropriate outcome batteries for future trials of novel compounds.
    

Eligibility criteria:

        Inclusion criteria:

          -  Age 18-64

          -  SCID diagnosis of Schizophrenia or Schizoaffective Disorder.

          -  PANSS 3 factor negative symptom (screening and baseline visit 1 and visit 3) score of
             >20 and PANSS total score between 60-110. Any degree of positive symptoms is
             acceptable but the total PANSS score must not exceed 110.

          -  SAS total score less than or equal to 12 and a Calgary Depression Inventory total
             score less than or equal to 10 and suicide (item 8) less than moderate (<2).

          -  Two consecutive CGI ratings at screening and baseline (visit 1 and 3) with no change
             in score.

          -  Estimated Glomerular Filtration Rate (GFR)(a measure of renal function) greater than
             or equal to 60.

        Exclusion criteria:

          -  Organic brain disorder, including epilepsy; mental retardation; or a medical condition
             whose pathology or treatment would likely alter the presentation or treatment of
             schizophrenia or significantly increase the risk associated with any of the proposed
             treatments

          -  Current DSM-IV diagnosis of drug/alcohol abuse in last month and current DSM-IV
             diagnosis of drug/alcohol dependence in last 6 months

          -  Pregnant female patients

          -  Impaired renal function

          -  Significant extrapyramidal symptoms (as reflected by a total score of 10 or above on
             the SAS scale), and depressive symptoms (as reflected by a score of 10 or above on the
             Calgary Depression Scale for Schizophrenia)

          -  Patients who are unable to or unwilling to participate in the Cognitive assessment
             (MATRICS) and the electrophysiology tasks .

          -  Patients on clozapine
Systematic Evaluation of Antiviral Medication in Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: Valacyclovir; Placebo
Intervention description: 1 g PO BID x 2 weeks after 2 weeks it goes up to 1.5 g PO BID x 16 weeks along with antipsychotic; 2 pills twice a day x 2 weeks, after 2 weeks 3 pills twice a day x 16 weeks along with antipsychotic
Intervention MeSH terms: Valacyclovir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to examine whether antiviral medication will help improve
      psychotic symptoms and cognition in individuals early in the course of schizophrenia or
      schizoaffective disorder who are exposed to herpes simplex virus, type 1 (HSV 1), a virus
      that causes commonly occurring and recurrent cold sores.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Both genders between the ages of 18-50 years

          -  Schizophrenia or schizoaffective disorder as defined in DSM-IV

          -  Duration of illness 10 years or less

          -  On a stable dose of an antipsychotic medication for at least a month

          -  Should score 4 or more on at least one of the subscales of PANSS

          -  Positive for HSV1

          -  Written informed consent

        Exclusion Criteria:

          -  Substance abuse in the last month/dependence 6 months prior to the study

          -  History of, or current medical/neurological illnesses which affects CNS function e.g.,
             epilepsy, head injury with prolonged loss of consciousness

          -  Pregnancy

          -  History of immune disorders, HIV infection or currently receiving immunosuppressants

          -  Subjects on regular antiviral therapy

          -  History of hypersensitivity to Valacyclovir

          -  Mental retardation as defined in DSM-IV
Pemetrexed Plus Gemcitabine in Metastatic Breast Cancer Patients After Receiving Taxane Therapy
Condition: Breast Cancer; Breast Neoplasms
MeSH terms: Breast Neoplasms
Intervention: Pemetrexed; Gemcitabine; Gemcitabine; Pemetrexed
Intervention description: 500 mg/m2, intravenous (IV), every 14 days, until disease progression; 1500 mg/m2, intravenous (IV), every 14 days, until disease progression; 1000 mg/m2, intravenous (IV), on Days 1 and 8 of 21-day cycle, until disease progression; 500 mg/m2, intravenous (IV), every 21 days, until disease progression
Intervention MeSH terms: Gemcitabine; Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 73.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cancer of Breast; Cancer of the Breast

Summary:

      The purpose of the study is to determine if the two drugs can help patients feel better while
      causing the tumor to become smaller or disappear; evaluate the safety of giving both
      pemetrexed and gemcitabine in patients with advanced breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have received prior chemotherapy with Taxol (paclitaxel) or Taxotere (docetaxel).

          -  Less than 3 different chemotherapy treatments for metastatic disease.

          -  Prior treatment with hormonal and/or radiation therapy.

          -  Must have disease that can be measured.

          -  Must be able to take care of self needs for example personal hygiene

        Exclusion Criteria:

          -  Must not be pregnant or breast-feeding.

          -  Cancer that has spread to the brain.

          -  Treatment with Gemcitabine or Pemetrexed

          -  Unable to take folic acid or Vitamin B12

          -  Treatment for another cancer within the last 5 years
A Proof of Concept and Dose Ranging Study in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: AZD5672; Etanercept; Placebo; AZD5672; AZD5672; AZD5672
Intervention description: 20 mg oral, once daily; 50 mg, subcutaneous injection, weekly; placebo, oral, once daily; 50 mg oral, once daily; 100 mg oral, once daily; 150 mg oral, once daily
Intervention MeSH terms: N-(1-(3-(3,5-difluorophenyl)-3-(4-methanesulfonylphenyl)propyl)piperidin-4-yl)-N-ethyl-2-(4-methanesulfonylphenyl)acetamide; Etanercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 373.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis; RA; AZD5672

Summary:

      This study is being carried out to investigate if AZD5672 is effective in treating Rheumatoid
      Arthritis (RA) and if so how it compares to placebo (a substance which does not have any
      action) and etanercept (a medicine already available to treat Rheumatoid Arthritis) when
      added to treatment with methotrexate. The purpose of this study is also to find out which
      dose of AZD5672 is the most effective at treating RA and to find out how well the body
      tolerates AZD5672 when taken for up to 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of RA with active disease defined as: ≥4 swollen joints and ≥6
             tender/painful joints, and either have (blood tests) elevated erythrocyte
             sedimentation rate (ESR) or C-reactive protein (CRP).

          -  At least one of the following: documented history of positive rheumatoid factor (blood
             test), current presence of positive rheumatoid factor (blood test), baseline
             radiographic erosion, presence of serum anti-cyclic citrullinated peptide antibodies
             (bloo

          -  Be receiving either: Oral (tablets) or subcutaneous (injection) methotrexate for at
             least 6 months prior to randomisation.

        Exclusion Criteria:

          -  Any other inflammatory disease in addition to RA that may interfere with the study
             (e.g. polymyalgia rheumatica, giant cell arteritis, reactive arthritis, etc).

          -  Current chronic pain disorders including fibromyalgia and chronic fatigue syndromes.