bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 2a Study to Assess Safety & Pharmacokinetics of Sustained Release Sodium Nitrite in Patients With Diabetic Pain
Condition: Diabetes
Intervention: Sodium nitrite; Placebo
Intervention description: Sustained release formulation of sodium nitrite; Placebo tablets containing same excipients and coatings used in the active tablets, without sodium nitrite being added.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: neuropathy

Summary:

      In this study, subjects with diabetic neuropathic pain (DNP) will be treated for 12 weeks
      with either placebo, 40 or 80 mg sustained release sodium nitrite (TV1001sr) twice daily.
      Primary endpoints will be safety and pharmacokinetics. Assessment of the study medications
      affects on pain following treatment will also be recorded.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female subjects must be post-menopausal, sterilized or using suitable birth control

          -  Diagnosis of diabetes (HbA1c > 6.0)

          -  Diagnosis of diabetic peripheral neuropathy pain in feet

          -  Presence of ongoing diabetic neuropathic for at least 3 months

          -  A pain score of greater than or equal to 4 on the Numerical Pain Rating Scale at
             screening

          -  Ability to provide written informed consent

        Exclusion Criteria:

          -  Patients with fibromyalgia or regional pain caused by lumbar or cervical compression

          -  History or diagnosis of significant neurological disease

          -  History and diagnosis of clinically significant psychiatric diseases

          -  Serious liver disease

          -  Poorly controlled diabetes

          -  Hypersensitivity to sodium nitrite or related compounds

          -  Life expectancy < 6 months

          -  A chronic illness that may increase the risks associated with this study

          -  Active malignancy requiring active anti-neoplastic therapy that will, in the opinion
             of the investigator, interfere with study treatment or participation

          -  Pregnant or nursing women

          -  Current diagnosis of alcohol or other substance abuse

          -  Current use of sildenafil or other phosphodiesterase Type 5 Inhibitors

          -  History of methemoglobinemia, (met-Hb ≥ 15%)

          -  Subject is involved in litigation or receives worker's compensation

          -  Inability to speak English
Early Neuromuscular Electrical Stimulation For Quadriceps Muscle Activation Deficits Following Total Knee Replacement
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Neuromuscular Electrical Stimulation (NMES); Standard Rehabilitation Protocol
Intervention description: NMES 20 minutes twice a day for 6 weeks plus standard physical therapy; Standard physical therapy for 8 weeks after surgery
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: electrical stimulation; total knee arthroplasty; quadriceps; muscle; arthroscopy

Summary:

      The purpose of this study is to determine whether early intervention with neuromuscular
      electrical stimulation (NMES) for muscle strengthening immediately after total knee
      arthroplasty (TKA) is more effective than voluntary exercise alone in countering changes in
      quadriceps muscle activation, force production, and function in older adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  50-85 years of age

          -  Scheduled for a primary unilateral TKA

          -  Cognitive status that allows patients to consistently comprehend and repeat back
             directions regarding the details of the study

        Exclusion Criteria:

          -  History of uncontrolled hypertension or uncontrolled diabetes

          -  Body mass index greater than 35 kg/m^2

          -  Neurological, vascular or cardiac problems that significantly limit function

          -  Moderate or severe osteoarthritis or other orthopedic conditions in the non-operated
             lower extremity that limit function
A Dose Ranging Study of AIN457 in Patients With Moderate to Severe Chronic Plaque-type Psoriasis
Condition: Chronic Plaque-type Psoriasis
MeSH terms: Psoriasis
Intervention: AIN457; 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: 125.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Moderate to severe chronic plaque-type psoriasis; AIN457; dermatology

Summary:

      The purpose of the study is to determine whether, in patients with moderate to severe
      plaque-type psoriasis, AIN457 administered subcutaneously reduces the severity of psoriasis
      symptoms and the extent to which the patient's body area is affected by the disease (compared
      to placebo).
    

Eligibility criteria:

        Inclusion Criteria:

        Chronic plaque-type psoriasis diagnosed for at least 6 months at time of randomization

        At randomization, moderate to severe psoriasis as defined by:

          -  PASI score of 12 or greater and,

          -  IGA score of 3 or greater and,

          -  Body Surface Area (BSA) affected by plaque-type psoriasis of 10% or greater At
             screening and randomization, chronic plaque-type psoriasis considered inadequately
             controlled by topical treatment.

        Exclusion Criteria:

          -  Forms of psoriasis other than chronic plaque-type

          -  Drug-induced psoriasis (e.g., new onset or current exacerbation from beta-blockers,
             calcium channel inhibitors or lithium) at randomization

          -  Previous exposure to AIN457

          -  Ongoing use of prohibited psoriasis treatments / medications and other prohibited
             medication at randomization. Washout periods detailed in the protocol have to be
             adhered to

          -  Known immunosuppression (e.g., AIDS) at screening and / or randomization

          -  History or evidence of active tuberculosis at screening

          -  Active systemic infections (other than common cold)

          -  History or symptoms of malignancy of any organ system, treated or untreated, within
             the past 5 years.

          -  Any severe, progressive or uncontrolled medical condition at randomization that in the
             judgment of the investigator prevents the patient from participating in the study

          -  Any clinically significant abnormal laboratory tests at randomization, that in the
             judgment of the investigator prevents the patient from participating in the study

          -  Inability or unwillingness to undergo repeated venipuntures

          -  History or evidence of drug or alcohol abuse

          -  Pregnant or nursing (lactating) women

        Other protocol-defined inclusion/exclusion criteria may apply
A Study of Naldemedine (S-297995) for the Treatment of Opioid-Induced Constipation in Adults With Non-Malignant Chronic Pain Receiving Opioid Therapy
Condition: Opioid-induced Constipation
MeSH terms: Chronic Pain; Constipation; Opioid-Induced Constipation
Intervention: Placebo; Naldemedine
Intervention description: Matching placebo tablets administered orally once a day.; Naldemedine tablets administered orally once a day.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 244.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Opioid Therapy; Non-Malignant Chronic Pain; Opioid-Induced Constipation

Summary:

      The purpose of this study is to determine efficacy and safety of naldemedine for the
      treatment of opioid-induced constipation in adults with non-malignant chronic pain receiving
      opioid therapy for ≥ 3 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects aged 18 years or older at time of informed consent with non-malignant chronic
             pain experiencing opioid-induced constipation

          -  Subjects with < 3 spontaneous bowel movements a week and experiencing bowel symptoms

          -  Subjects receiving chronic opioid therapy due to non-malignant pain for ≥ 3 months

        Exclusion Criteria:

          -  Evidence of clinically significant gastrointestinal disease

          -  History of chronic constipation prior to starting analgesic medication or any
             potential non-opioid cause of bowel dysfunction that may be a major contributor to the
             constipation

          -  Severe constipation that has not been appropriately managed such that the subject is
             at immediate risk of developing serious complications of constipation
Treatment of Tendon Injury Using Allogenic Adipose-derived Mesenchymal Stem Cells (Rotator Cuff Tear)
Condition: Rotator Cuff Tear
MeSH terms: Rotator Cuff Injuries; Tendon Injuries
Intervention: allogenic adipose stem cell injection; fibrin glue/normal saline injection; normal saline injection
Intervention description: Intervention will be done with stem cell injection, 0.5cc (Total: 10 million cells), fibrin glue injection 0.5cc and range of motion exercise.; Total 1cc of fibin glue and normal saline mixture injection and range of motion exercise; Total 1cc of normal saline injection and range of motion exercise
Intervention MeSH terms: Fibrin Tissue Adhesive
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 19 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: adipose derived mesenchymal stem cell; allogeneic stem cell; Rotator cuff tear

Summary:

      Main purpose of this study is to evaluate efficacy of allogenic adipose-derived mesenchymal
      stem cells in treatment of tendon injury. ALLO-ASC will be administrated to the patients with
      supraspinatus partial thickness tear by ultrasonographic guided injection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  clinically diagnosed as rotator cuff tear (supraspinatus partial thickness tear)

          -  recurrent pain in spite of conservative treatment such as physical therapy,
             medication, steroid injection

          -  symptom duration is over 3 months

          -  supraspinatus partial thickness tear proven ultrasonography and magnetic resonance
             image(MRI)

          -  patient that can understand the clinical trials

        Exclusion Criteria:

          -  patient that underwent other injection treatment within 6 weeks

          -  some associated diseases (adhesive capsulitis, full thickness supraspinatus tear,.
             arthritis of related joint to the target lesion, muscle weakness or atrophy,
             innervated by suprascapular nerve, paralysis of related joint to target lesion,
             proximal humeral fracture, infectious disease, bilateral rotator cuff tear,
             generalized pain syndrome, radiculopathy, rheumatoid arthritis, impaired sensibility,
             dementia, history of allergic or hypersensitive reaction to bovine-derived proteins or
             fibrin glue and contraindication to MRI

          -  patient that enrolled other clinical trials within 30 days

          -  history of drug/alcohol addiction, habitual smoker, operation, allergic reaction to
             fibrin glue, local anesthetics and bovine-derived proteins and severe medical disease.
Efficacy and Safety of Alisporivir Alone or Combined With RBV or PEG in Chronic Hepatitis C Genotype 2 and 3 Treatment-naïve Participants
Condition: Hepatitis C; Chronic Pain
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis; Chronic Pain
Intervention: Alisporivir; Peginterferon alfa-2a; Ribavirin
Intervention description: ALV 200 mg soft gel capsules administered orally; PEG 180 μg administered via subcutaneous (s.c.) injection once weekly; RBV 400 mg (2 x 200 mg tablets) administered orally twice daily (BID)
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 340.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Chronic hepatitis C genotype 2; Chronic hepatitis C genotype 3; Cyclophilin inhibitor

Summary:

      The study is to investigate whether alisporivir (ALV; DEB025) alone or in combination with
      either ribavirin (RBV) or peginterferon alfa-2a (PEG) is more efficient compared to standard
      of care (PEG+RBV) in treatment-naïve participants with hepatitis C virus (HCV) genotype 2 and
      3. In addition, triple therapy with DEB025 plus standard of care will be applied to
      participants not achieving rapid viral response (RVR) in the different arms.
    

Eligibility criteria:

        Inclusion criteria:

          -  Chronic hepatitis C viral infection

          -  Plasma HCV RNA level lower limit ≥ 10,000 IU/ml assessed by quantitative polymerase
             chain reaction (qPCR) or equivalent at screening (no upper limit)

          -  HCV genotype 2 or 3

          -  No previous treatment for hepatitis C infection

        Exclusion criteria:

          -  Evidence of cirrhosis at the time of screening

          -  Evidence of hepatocellular carcinoma at the time of screening

          -  Any other cause of relevant liver disease other than HCV

          -  Alanine aminotransferase (ALT) ≥ 10 times upper limit of normal (ULN)

          -  Other protocol-defined inclusion/exclusion criteria may apply
A Study to Evaluate Ocrelizumab in Combination With Methotrexate Compared With Infliximab Plus Methotrexate in Patients With Active Rheumatoid Arthritis Currently Responding Inadequately to Etanercept or Adalimumab
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Infliximab; Methotrexate; Methylprednisolone; Ocrelizumab; Placebo
Intervention description: Intravenous repeating dose; Oral or parenteral repeating dose; Intravenous repeating dose; Intravenous repeating dose; Intravenous repeating dose
Intervention MeSH terms: Methylprednisolone; Infliximab; Methotrexate; Ocrelizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: RA; Arthritis

Summary:

      This is a Phase II, randomized, active-controlled, double-blind, double-dummy,
      parallel-group, multicenter study in the United States enrolling patients with active RA. The
      study will enroll approximately 290 patients at approximately 130 sites.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age >= 18 years

          -  Current treatment for RA on an outpatient basis

          -  Active disease

          -  Currently receiving 50 mg etanercept subcutaneously (SC) every week or 40 mg
             adalimumab SC every other week.

          -  Considered by Investigator to be a primary non-responder to their first anti-TNFÎ±
             treatment for efficacy reasons

        Exclusion Criteria:

          -  Rheumatic autoimmune disease other than RA, or significant systemic involvement
             secondary to RA

          -  History of, or current, inflammatory joint disease other than RA (e.g., gout, reactive
             arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) or
             other systemic autoimmune disorder (e.g., systemic lupus erythematosus, inflammatory
             bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease or
             other overlap syndrome)

          -  Previous treatment with a any biologic therapy for RA (including investigational
             products with the exception of etanercept or adalimumab

          -  Treatment with more than one prior anti-TNFÎ± therapy
Effect of Roflumilast at Acute Exacerbations of Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease With (Acute) Exacerbation
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Roflumilast; Placebo
Intervention description: 500 µg tablet, od, oral administration in the morning after breakfast; tablet, od, oral administration in the morning after breakfast
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 81.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; Chronic obstructive pulmonary disease; Roflumilast

Summary:

      The purpose of this trial is to investigate if roflumilast can reduce the neutrophilic
      inflammation at acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD). In
      addition, the potential benefit of roflumilast on severity and recovery periods of acute COPD
      exacerbations will be assessed using patient diaries and questionnaires.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent (IC)

          -  Age ≥ 40 years

          -  History of COPD for at least 12 months prior to enrollment (Visit V0)

          -  Chronic productive cough for 3 months in each of the 2 years prior to enrollment (if
             other causes of productive cough have been excluded) and/or an exacerbation with
             predominantly bronchitic symptoms at enrollment

          -  Presentation of an acute exacerbation of COPD that will be associated with increased
             sputum volume or change in sputum colour

          -  Documented fixed airway obstruction determined by an FEV1/FVC ratio
             (post-bronchodilator) < 70% (if a pulmonary function test is not possible at Visit V0
             a previous measurement can be taken which must not be older than 6 months)

          -  Former smoker (defined as: smoking cessation at least 1 year ago) or current smoker
             both with a smoking history of at least 10 pack years

        Main Exclusion Criteria:

          -  Diagnosis of asthma and/or other relevant lung disease

          -  Known alpha-1-antitrypsin deficiency

          -  Recurrent exacerbations (within 8 weeks of a preceding exacerbation)

          -  Treatment of current exacerbation with oral corticosteroids and/or antibiotics already
             started at enrollment

          -  Treatment with PDE4 inhibitors within 3 months prior to Visit V0

          -  Other protocol-defined exclusion criteria may apply
Safety and Efficacy Study of ISIS 301012 (Mipomersen) Administration in High Risk Statin Intolerant Subjects
Condition: Metabolic Diseases; Hyperlipidemias; Metabolic Disorder; Hypercholesterolemia; Dyslipidemias; Lipid Metabolism Disorders
MeSH terms: Hypercholesterolemia; Dyslipidemias; Hyperlipidemias; Metabolic Diseases; Lipid Metabolism Disorders
Intervention: mipomersen; placebo
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: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: statin intolerant; hypercholesterolemia

Summary:

      The purpose of this study is to determine safety and efficacy of mipomersen (ISIS 301012) in
      the reduction of total cholesterol, low density lipoprotein cholesterol (LDL-C), and
      apolipoprotein B (apoB) in high risk subjects intolerant to statins.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of statin intolerance

          -  Diagnosis of Coronary Artery Disease (CAD)

          -  Diagnosis of hypercholesterolemia

          -  Stable weight for > 6 weeks

        Exclusion Criteria:

          -  Significant health problems in the recent past (≤24 weeks) including heart attack,
             heart surgery, heart failure, uncontrolled hypothyroidism, blood disorders, digestive
             problems, disease of central nervous system, cancer, liver or renal disease
Memantine for Prevention of Cognitive Decline in Patients With Breast Cancer
Condition: Cognitive Decline; Chemo-brain
MeSH terms: Cognitive Dysfunction
Intervention: Memantine
Intervention description: memantine dose
Week 1: 5 mg dose once daily
Week 2: 5 mg dose twice daily
Week 3: 5 mg each morning/10 mg each evening
Week 4 through the end of Chemotherapy: 10 mg dose twice daily
Total duration: 12 - 26 weeks (depending on chemotherapy regimen)
Intervention MeSH terms: Memantine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Purpose: To conduct a one-arm phase II trial to: (1) compare changes in pre- to
      post-chemotherapy cognitive function in a cohort of patients with breast cancer receiving
      memantine to historical controls; (2) examine how depression, anxiety, fatigue, baseline
      Intelligence Quotient (IQ), and cognitive effort relate to objective and self-reported
      cognitive function; and (3) estimate the feasibility of conducting a clinical trial of
      memantine for attenuating cognitive decline in patients with breast cancer during
      chemotherapy.

      Participants: Adult patients with stage I-III breast cancer scheduled for adjuvant or
      neoadjuvant chemotherapy.

      Procedures (methods): Cognitive assessments will be performed within one week of initiating
      and four weeks after completion of chemotherapy. Patients will receive memantine 10 mg twice
      daily between the pre- and post-chemotherapy study assessments. Cognitive function will be
      assessed objectively using a computerized cognitive test (Delayed Matching to Sample (DMS)
      test) and a standard neuropsychological battery. To assess subjective cognitive function, the
      Patient Reported Outcome Measurement Information System (PROMIS) Cognitive Function measure
      will be used. Depression, anxiety, fatigue, menopausal status, and sleep will be assessed as
      covariates.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to provide informed consent

          -  At least 18 years of age

          -  Able to speak English

          -  Diagnosed with breast cancer, Stages I-III

          -  Scheduled for adjuvant or neoadjuvant chemotherapy

        Exclusion Criteria:

          -  A history of adverse reaction to memantine

          -  Another cancer diagnosis with an estimated survival of less than five years

          -  Previous chemotherapy exposure

          -  Severe cognitive impairment, defined as Blessed Orientation Memory Concentration Test
             (BOMC) ≥ 11.

          -  Pregnancy, confirmed by a negative pregnancy test within 30 days of study enrollment,
             or breastfeeding

          -  Current alcohol or drug abuse