bioihbjkbjnl/mcl2 huggingface dataset:
ASCEND GO-2: Study of RVT-1401 for the Treatment of Participants With Active, Moderate to Severe Graves' Ophthalmopathy ( GO )
Condition: Graves' Ophthalmopathy (GO)
MeSH terms: Eye Diseases; Graves Ophthalmopathy
Intervention: RVT-1401 (Administered via subcutaneous injection); Placebo (Administered via subcutaneous injection)
Intervention description: RVT-1401 is a fully human anti-neonatal Fc receptor (FcRn) monoclonal antibody.; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: IMVT-1401; Graves' Orbitopathy; Thyroid Eye Disease

Summary:

      The purpose of the current study is to assess the efficacy and safety/tolerability of three
      dose regimens of RVT-1401 in the treatment of active, moderate to severe GO participants. In
      addition, the study is designed to characterize the effect of RVT-1401 exposure on reduction
      in anti-TSHR IgG
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female ≥18 years of age.

          2. Clinical diagnosis of Graves' disease with hyperthyroidism associated with active,
             moderate to severe Graves' Ophthalmopathy (GO) with a Clinical Activity Score (CAS) ≥4
             for the most severely affected eye at Screening and Baseline (on the 7-item scale).

          3. Onset of active GO within 9 months of screening.

          4. Moderate-to-severe active GO (not sight-threatening but has an appreciable impact on
             daily life), usually associated with one or more of the following: lid retraction ≥2
             millimeters (mm), moderate or severe soft tissue involvement, proptosis ≥3 mm above
             normal for race and gender, and/or inconstant or constant diplopia.

          5. Other, more specific inclusion criteria are defined in the protocol

        Exclusion Criteria:

          1. Use of any steroid (intravenous, oral, steroid eye drops) for the treatment of GO or
             other conditions within 3 weeks prior to Screening. Steroids cannot be initiated
             during the trial. Exceptions include topical and inhaled steroids which are allowed.

          2. Use of rituximab, tocilizumab, or any monoclonal antibody for immunomodulation within
             the past 9 months prior to Baseline.

          3. Total IgG level <6 grams per liter (g/L) at Screening.

          4. Absolute neutrophil count <1500 cells per meter squared (cells/mm^3) at Screening.

          5. Participants with decreased best corrected visual acuity due to optic neuropathy as
             defined by a decrease in vision of 2 lines on the Snellen chart, new visual field
             defect, or color defect secondary to optic nerve involvement within the last 6 months
             at Screening.

          6. Previous orbital irradiation or surgery for GO.

          7. Other, more specific exclusion criteria are defined in the protocol
Study of MR-107A-02 in the Treatment of Post Surgical Dental Pain.
Condition: Acute Pain; Post Operative Pain; Pain
MeSH terms: Pain, Postoperative; Acute Pain
Intervention: MR-107A-02; Placebo
Intervention description: MR-107A-02 oral tablet; Placebo oral tablet
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: double blind, placebo controlled
Enrollment: 111.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      MR-107A-02 is being studied to investigate its efficacy, safety and dose-response after
      dental surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females ≥18 years of age.

          2. Requirement for dental surgery for extraction of ≥2 third molars, at least 1 of which
             involves partial or complete mandibular bony impaction.

          3. Pain Intensity (PI) using a Numeric Pain Rating Scale (NPRS) ≥5 during the 5 hours
             following the end of surgery in the eligibility assessment as well as in the baseline
             assessment immediately pre-dosing.

          4. Rating of moderate or severe pain on a 4-point categorical pain rating scale (i.e.,
             none, mild, moderate, severe) during the 5 hours following the end of surgery.

        Exclusion Criteria:

          1. Previously dosed with MR-107A-02.

          2. Subject with known hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs).

          3. Active GI bleeding or a history of peptic ulcer disease, active inflammatory bowel
             disease, e.g., Crohn's Disease or ulcerative colitis,or bleeding disorders that may
             affect coagulation.

          4. Moderate or severe hypertension, prior stroke or transient ischemic attack.

          5. Use of any investigational drug within 28 days, or 5 half-lives, prior to consent
             whichever is longer.

          6. Use of medications with the potential to interact with MR-107A-02.

          7. Other acute or chronic medical or psychiatric condition or laboratory abnormality that
             may increase the risk associated with study participation or investigational product
             administration or may interfere with the interpretation of study results and, in the
             judgment of the investigator.
Study to Assess the Efficacy and Safety of Three Doses of PT001 in Japanese Subjects With Moderate to Severe COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Glycopyrronium MDI 28.8 micrograms; Glycopyrronium MDI 14.4 micrograms; Glycopyrronium MDI 7.2 micrograms; Placebo MDI
Intervention description: Glycopyrronium MDI 28.8 micrograms; Glycopyrronium MDI 14.4 micrograms; Glycopyrronium MDI 7.2 micrograms; Placebo Inhalation Aerosol
Intervention MeSH terms: Glycopyrrolate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: randomized, double-blind, chronic-dosing (7-day), four-period, four-treatment, placebo-controlled, crossover, multi-center
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 66.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The overall objective of this study was to assess the efficacy and safety of GP MDI relative
      to placebo in Japanese subjects with moderate to severe COPD. Each subject received the 4
      separate study treatments, scheduled as four, 7-day, treatment periods for a total treatment
      duration of 28 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical history of COPD with a moderate to severe classification

          -  Current and former smokers with a history of at least 10 pack-years of cigarette
             smoking.

        -Post-bronchodilator FEV1 must be ≥30% and <80% predicted normal value-

        Exclusion Criteria:

          -  Pregnancy

          -  Primary asthma diagnosis; Poorly controlled COPD defined as acute worsening of COPD
             that required treatment with corticosteroids or antibiotics in the 6-week interval
             prior to Screening or between Screening and Visit 2;

          -  Clinically significant abnormal ECG

          -  Other active pulmonary disease such as active tuberculosis, lung cancer,
             bronchiectasis, sarcoidosis, lung fibrosis, primary pulmonary hypertension,
             interstitial lung disease, and uncontrolled sleep apnea; Cancer that was not in
             complete remission for at least 5 years;

          -  Diagnosis of angle closure glaucoma

          -  A documented myocardial infarction within 1 year of Screening.
Effect of Intrathecal Clonidine in Hypertensive Subjects With Poorly Controlled Blood Pressure
Condition: Hypertension
MeSH terms: Hypertension
Intervention: clonidine
Intervention description: Intrathecal Clonidine
Intervention MeSH terms: Clonidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 30 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: intrathecal; clonidine; poorly; controlled; hypertension

Summary:

      The purpose of this study is to determine the acute efficacy of intrathecal clonidine to
      reduce blood pressure in hypertensive subjects with poor blood pressure control and describe
      its effects on cardiovascular function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Hypertension

          -  Stable systolic blood pressure >140 mmHg and < 190 mmHg

          -  On 3 or more antihypertensive medications

          -  On a diuretic

          -  Patients must be able to understand the risks

        Exclusion Criteria:

          -  Allergy to clonidine

          -  Presently on clonidine orally or transdermally

          -  Known or suspected correctable causes of secondary hypertension

          -  Breast Feeding or Pregnant women

          -  Unstable Ischemic Heart Disease

          -  Unstable Angina

          -  Intracoronary Stent Placement

          -  Coronary bypass within last 6 months

          -  Myocardial Infarction within last 6 months

          -  Congestive Failure

          -  Cardiac Arrhythmias

          -  Known Cerebral Vascular Disease

          -  Renal Disease

          -  Evidence of Injection Site Infection

          -  Known Bleeding Disorders

          -  Hepatic Insufficiency

          -  Renal Insufficiency

          -  Participation in an investigational drug study within 30 day of enrollment

          -  Prohibited Medications:

               -  Clonidine

               -  Yohimbine

               -  Tricyclic Antidepressants

               -  Mirtazapine

               -  Digitalis

               -  Reserpine

               -  Guanethidine

               -  Non-Steroidal Anti-inflammatory Medication

               -  Alcohol or Barbiturates within 48 hours of study procedure
A Study to Investigate the Neuroprotective Effect of PROCRIT (Epoetin Alfa) Versus Placebo in Cancer Patients Who Develop Chemotherapy-induced Peripheral Neuropathy
Condition: Peripheral Neuropathy, Chemotherapy-induced
MeSH terms: Peripheral Nervous System Diseases
Intervention: PROCRIT 40,000 IU QW; Placebo
Intervention description: Epoetin alpha (PROCRIT) 40,000 IU every week (QW) for 18 weeks (IV or SC); Equivalent volume to PROCRIT (1 mL) administered (QW) for 18 weeks (IV or SC)
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Peripheral neuropathy; Chemotherapy-induced; Hemoglobin level; Cancer; Taxane; Platinum-based chemotherapy

Summary:

      The purpose of this study is to evaluate the neuroprotective effect of PROCRIT (epoetin alfa,
      a glycoprotein that stimulates red blood cell production) versus placebo in patients with
      cancer who develop chemotherapy-induced peripheral neuropathy due to combination Taxane and
      Platinum-Based treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a diagnosis of cancer , and no history of peripheral neuropathy

          -  Have had the appropriate surgery for carcinoma and are no more than 12 weeks
             post-operatively at study entry

          -  Have not received chemotherapy (chemotherapy naïve patients) and are scheduled to
             receive at least 4 cycles of combination taxane and platinum-based chemotherapy

          -  Have a hemoglobin value of >= 10 and < 12 g/dL

          -  have a life expectancy of at least 6 months

        Exclusion Criteria:

          -  Patients who have had prior treatment with PROCRIT (epoetin alfa) or similar drugs
             (erythropoietic agents) within the last 2 months

          -  Have used experimental treatments within the last year that are reported or
             hypothesized to have neuroprotective potential, including amifostine, cyanocobalamin
             (vitamin B12), alpha-tocopherol (Vitamin E), glutamine, and gabapentin

          -  have anemia due to factors other than cancer/chemotherapy, or have ongoing neuropathy
             due to any cause

          -  Received a transfusion of platelets or packed red blood cells within 28 days prior to
             the first dose of study medication

          -  Have a history of pulmonary emboli, deep vein thrombosis, ischemic stroke or any other
             history of arterial or venous thrombotic events
A Study to Evaluate the Safety and Efficacy of CCX168 in Subjects With ANCA-Associated Vasculitis
Condition: Vasculitis
MeSH terms: Vasculitis
Intervention: Placebo; CCX168
Intervention description: BID for 84 days; BID for 84 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 67.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The aim of this trial is to optimize the treatment to induce remission for patients with
      non-life-threatening anti-neutrophil cytoplasmic antibody vasculitis (AAV). The intent is to
      reduce the toxicity of induction therapy by reducing the overall exposure to or eliminating
      entirely the use of systemic corticosteroids during the induction period with an inhibitor of
      the complement C5a receptor plus cyclophosphamide or rituximab.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Clinical diagnosis of granulomatosis with polyangiitis (Wegener's), microscopic
             polyangiitis or renal limited vasculitis

          -  Male and postmenopausal or surgically sterile female subjects aged at least 18 years
             with new or relapsed AAV where treatment with cyclophosphamide or rituximab would be
             required

          -  Positive indirect immunofluorescence (IIF) test for P-ANCA or C-ANCA, or positive
             ELISA test for anti-proteinase-3 (PR3) or anti-myeloperoxidase (MPO) at screening

          -  Estimated glomerular filtration rate (eGFR) ≥ 20mL/min

          -  Have at least one "major" item, or at least 3 non-major items, or at least 2 renal
             items on the BVAS version 3

        Key Exclusion Criteria:

          -  Severe disease as determined by rapidly progressive glomerulonephritis, alveolar
             hemorrhage, hemoptysis, rapid-onset mononeuritis multiplex or central nervous system
             involvement

          -  Any other multi-system autoimmune disease

          -  Medical history of coagulopathy or bleeding disorder

          -  Received cyclophosphamide within 12 weeks of screening; if on azathioprine,
             mycophenolate mofetil or methotrexate at the time of screening, these drugs must be
             withdrawn prior to receiving the cyclophosphamide or rituximab dose on Day 1

          -  Received high-dose intravenous corticosteroids within 4 weeks of screening

          -  On an oral dose of a corticosteroid of more than 10mg prednisone-equivalent at the
             time of screening

          -  Received rituximab or other B-cell antibody within 52 weeks of screening or 26 weeks
             provided B cell reconstitution has occurred; received anti-TNF treatment, abatacept,
             alemtuzumab, IVIg or plasma exchange within 12 weeks of screening
Effects of Tofacitinib (CP-690,550) on Magnetic Resonance Imaging (MRI)- Assessed Joint Structure In Early Rheumatoid Arthritis (RA)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Tasocitinib plus Methotrexate; Tofacitinib plus placebo methotrexate; Placebo tofacitinib plus Methotrexate
Intervention description: Tofacitinib (CP 690,550) 10 mg BID, tablets + methotrexate (MTX) 10 mg/wk to 20 mg/wk, titrated over 2 months; Tofacitinib (CP-90,550) 10 mg BID, tablets. Placebo to match methotrexate (MTX) capsules titrated as in Treatment Arm 1.; Methotrexate (MTX) 10 mg/wk to 20 mg/wk, capsules, titrated over 2 months. Placebo in tablets to match tofacitinib
Intervention MeSH terms: Methotrexate; Tofacitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 109.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Early Rheumatoid Arthritis; Joint Structure; Magnetic Resonance Imaging; Janus Kinase (JAK) Inhibitor; Tasocitinib; Tofacitinib

Summary:

      Evaluation of efficacy and safety of tofacitinib (CP-690,550) for the treatment of early
      rheumatoid arthritis in adult patients with moderate to severe disease who are methotrexate
      naïve. The efficacy will be evaluated by exploring the effects on joint structure assessed by
      magnetic resonance imaging, x-rays and by standard clinical assessment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients with moderate to severe early rheumatoid arthritis (< 2 years) who are
             methotrexate and biologic disease modifying antirheumatic drug naive.

        Exclusion Criteria:

          -  Pregnant or lactating patients;

          -  Patients with renal or hepatic impairment or other severe or progressing disease;

          -  Patients with contraindication to magnetic resonance imaging with gadolinium contrast.
A Study to Assess the Safety, Tolerability and Effectiveness of MT-0814 for the Treatment of Age-related Macular Degeneration
Condition: Age-related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: MT-0814; Placebo
Intervention description: Randomly assigned dose; Placebo manufactured to mimic MT-0814
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 13.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Exudative; Wet; AMD; Age-related macular degeneration; Age related macular degeneration

Summary:

      Age-related macular degeneration (AMD) is the leading cause of blindness among adults in
      North America. The current standard of care for patients with exudative ("wet") AMD is
      anti-vascular endothelial growth factor (anti-VEGF) therapy which must be administered by an
      injection into the eye every 4-8 weeks. MT-0814 is being developed for the treatment of
      patients with exudative AMD, and could offer an alternative, safer and less burdensome
      therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must agree to sign informed consent form, and to comply with protocol requirements,
             including study visits.

          -  Must have clear optic media in the study eye that is capable of producing high-quality
             fundus images.

        Exclusion Criteria:

          -  Has active CNV due to causes other than AMD in the study eye.

          -  Has retinal vascular disease or retinal degeneration other than AMD in the study eye.

          -  Has had intraocular surgery, cataract surgery or LASIK surgery on the study eye within
             90 days prior to the study.

          -  Has had yttrium aluminum garnet (YAG) laser capsulotomy on the study eye within 30
             days prior to the study.

          -  Has active inflammation, infection, or other severe ocular disease in either eye.

          -  Has aphakia in the study eye.

          -  Has uncontrolled glaucoma or a history of previous glaucoma filter surgery in either
             eye.

          -  Is a contact lens wearer and is unable to discontinue their use in both eyes for the
             duration of the study.

          -  Has a serious allergy to, or experienced a prior significant adverse reaction to
             fluorescein angiography (FA) or indocyanine green angiography (ICGA).

          -  Has participated in any other clinical trial and/or has taken any investigational drug
             or product within 90 days prior to the study.

        Other protocol-defined inclusion/exclusion criteria could apply.
Employment-Based Depot Naltrexone Clinical Trial II
Condition: Opiate Dependence
MeSH terms: Opioid-Related Disorders
Intervention: Work Plus Naltrexone Contingency
Intervention description: Vivitrol, an extended-release depot formulation of naltrexone, was used. Participants were offered an inpatient opioid detoxification and oral naltrexone induction. Participants who complete the oral naltrexone induction (N=40) were randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and will be prescribed depot naltrexone for 6 months. Participants in the "Work Plus Naltrexone Contingency" condition earned access to working and earning salary by taking depot naltrexone injections once per month.
Intervention MeSH terms: Naltrexone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether employment-based naltrexone treatment
      proves effective in promoting depot naltrexone adherence and drug abstinence.
    

Eligibility criteria:

        Individuals were eligible if they:

          -  met the Diagnostic and Statistical Manual (DSM)-IV criteria for opioid dependence,

          -  reported using heroin at least 21 of the last 30 days while living in the community,

          -  were unemployed,

          -  were 18-65 years old,

          -  were medically approved for naltrexone,

          -  lived in or near Baltimore, MD.

        Individuals were excluded if they:

          -  were pregnant or breastfeeding,

          -  had serum aminotransferase levels over three times normal,

          -  had current hallucinations, delusions, or thought disorders, current suicidal or
             -homicidal ideation,

          -  expressed interest in methadone treatment,

          -  were required to use opioids for medical purposes,

          -  earned over $200 in taxable income over the previous 30 days,

          -  had physical limitations that would prevent them from using a keyboard, or were
             incarcerated or under constant monitoring by the criminal justice system.