bioihbjkbjnl/mcl2 huggingface dataset:
A Clinical Study to Assess the Safety and Efficacy of an Ophthalmic Solution (SkQ1) in the Treatment of Dry Eye Syndrome (DES)
Condition: Keratoconjunctivitis Sicca
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis; Keratoconjunctivitis Sicca
Intervention: Low Dose 0.155µg/mL SkQ1 ophthalmic solution; High Dose 1.55µg/mL SkQ1 ophthalmic solution; Placebo (Vehicle) opthalmic solution
Intervention description: eyedrops; eyedrops; eyedrops
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 91.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dry Eye; Dry Eye Syndrome; SkQ1; Keratoconjunctivitis; Dry Eye Disease

Summary:

      The purpose of this study is to evaluate whether SkQ1 ophthalmic solutions are safe and
      effective compared to placebo for the treatment of the signs and symptoms of dry eye
      syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be male or female of any race, at least 18 years of age

          -  Have provided written informed consent

          -  Have a reported history of dry eye syndrome

          -  Have a history of use or desire to use eye drops for dry eye

        Exclusion Criteria:

          -  Have any clinically significant eye findings that require therapeutic treatment or may
             interfere with study parameters

          -  Have previously had LASIK surgery within the last 12 months

          -  Have used Restasis® within 30 days of Visit 1

          -  Be a woman who is pregnant, nursing or planning a pregnancy

          -  Be unwilling to submit a urine pregnancy test if of childbearing potential

          -  Have a known allergy and/or sensitivity to the test article or its components,
             including the preservative benzalkonium chloride

          -  Be currently enrolled in an investigational drug or device study or have used an
             investigational drug or device within 30 days of Visit 1

          -  Have a condition or be in a situation which the investigator feels may put the subject
             at significant risk, may confound the study results, or may interfere significantly
             with the subject's participation in the study
Study of Inhaled Carbon Monoxide to Treat Idiopathic Pulmonary Fibrosis
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Intervention: inhaled carbon monoxide; Oxygen
Intervention description: The intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment.; Room air oxygen concentrations will be administered as placebo
Intervention MeSH terms: Carbon Monoxide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: idiopathic pulmonary fibrosis; IPF; pulmonary fibrosis; carbon monoxide

Summary:

      The purpose of this study is to determine whether low concentration inhaled carbon monoxide
      is effective in treating idiopathic pulmonary fibrosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults above the age of 18 and equal to or below the age of 85

          -  Diagnosis of IPF by biopsy or

          -  American Thoracic Society (ATS)/European Respiratory Society (ERS)/ Latin American
             Thoracic Association (ALAT) Guidelines (Am J Respir Crit Care Med Vol 183. pp
             788-824,2011)

          -  Forced vital capacity (FVC) greater than or equal to 50% predicted, greater than or
             equal to one month off all medications prescribed for IPF

        Exclusion Criteria:

          -  Evidence of active infection within the last month

          -  Significant obstructive respiratory defect

          -  Supplemental oxygen required to maintain an oxygen saturation over 88% at rest

          -  History of myocardial infarction within the last year, heart failure within the last 3
             years or cardiac arrhythmia requiring drug therapy

          -  History of smoking within 4 weeks of screening

          -  Pregnancy or lactation

          -  Participation in another therapeutic clinical trial
Pentosan Polysulfate Sodium and Meclofenamic Acid as Treatments in Patients With Psychotic Disorders
Condition: Psychotic Disorders; Schizophrenia; Schizoaffective Disorder; Bipolar Disorder
MeSH terms: Schizophrenia; Bipolar Disorder; Mental Disorders; Psychotic Disorders
Intervention: Meclofenamic acid; Pentosan polysulfate sodium
Intervention MeSH terms: Meclofenamic Acid; Pentosan Sulfuric Polyester
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Psychotic; Schizophrenia; Schizoaffective; Bipolar

Summary:

      This study evaluates the feasibility of administering meclofenamic acid or pentosan
      polysulfate sodium as an adjunctive treatment to patients diagnosed with a psychotic
      disorder. Half of participants will receive meclofenamic acid, while the other half will
      receive polysulfate sodium.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder,
             bipolar I disorder, delusional disorder, other specified schizophrenia spectrum and
             other psychotic disorders, unspecified schizophrenia spectrum and other psychotic
             disorders

          -  Negative pregnancy test in females of childbearing age

        Exclusion Criteria:

          -  Urine drug screen positive for psychostimulants such as cocaine, amphetamines and
             ecstasy

          -  Any infection, neoplasm, autoimmune disease or other primary inflammatory condition
             (3) Previous diagnosis of intellectual disability or dementia

          -  Current treatment with heparin

          -  Use of or allergy to non-steroidal anti-inflammatory agent or pentosan polysulfate
             sodium

          -  Current or anticipated corticosteroid use

          -  History of peptic ulcer disease, gastro esophageal reflux disease, or gastrointestinal
             bleeding

          -  Those on warfarin or any anticoagulant

          -  Current treatment with lithium or asthma medication

          -  Individuals with pre-existing liver, cardiac, or kidney disease
Panitumumab (ABX-EGF) Monotherapy in Patients With Metastatic Colorectal Cancer
Condition: Colorectal Cancer; Metastases
MeSH terms: Colorectal Neoplasms
Intervention: Panitumumab
Intervention description: Administered by intravenous infusion
Intervention MeSH terms: Panitumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 203.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Colon, Rectal Cancer; ABX-EGF, Panitumumab, EGFr; Immunex, Abgenix, Amgen; Metastatic Colorectal Cancer; Vectibix

Summary:

      The purpose of this study is to determine that panitumumab will have clinically meaningful
      anti-tumor activity in patients with metastatic colorectal cancer who have developed
      progressive disease or relapsed while on or after prior fluoropyrimidine, irinotecan and
      oxaliplatin chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologic diagnosis of colorectal adenocarcinoma (diagnostic tissue obtained by
             tissue biopsy)

          -  Metastatic colorectal carcinoma

          -  Eastern Cooperative Oncology Group of 0, 1 or 2

          -  Documented evidence of disease progression during, or following treatment, with
             fluoropyrimidine, irinotecan and oxaliplatin chemotherapy for metastatic colorectal
             cancer

          -  Radiographic documentation of disease progression during or within 6 months following
             the most recent chemotherapy regimen is required

          -  Bidimensionally measurable disease

          -  Tumor expressing low to negative levels of epidermal growth factor receptor (EGFr) by
             immunohistochemistry

          -  At least 2 but no more than 3 prior chemotherapy regimens for metastatic colorectal
             cancer

          -  Adequate hematologic, renal and hepatic function

        Exclusion Criteria:

          -  Symptomatic brain metastases requiring treatment

          -  Patient with a history of interstitial pneumonitis or pulmonary fibrosis or evidence
             of interstitial pneumonitis or pulmonary fibrosis

          -  Use of systemic chemotherapy or radiotherapy within 30 days before enrollment

          -  Prior anti-EGFr antibody therapy with the exception of the small molecule EGFr
             tyrosine kinase inhibitors, which are permitted

          -  Prior anti-tumor therapies including prior experimental agents or approved anti-tumor
             small molecules and biologics of short (less than 1 week) serum half-life within 30
             days before enrollment, or prior experimental or approved proteins within 6 weeks
             before enrollment
Endermotherapy for Children With Developmental Disabilities
Condition: Cerebral Palsy; Developmental Delay
MeSH terms: Cerebral Palsy; Developmental Disabilities
Intervention: Endermotherapy; Passive manual stretching
Intervention description: The subjects will receive a single session of endermotherapy applied to the gastrocnemius/soleus muscle on the more affected side for 5 minutes. The treatment will be conducted by a qualified physiotherapist.; The subjects will receive a single session of passive manual stretching of the gastrocnemius/soleus muscle on the more affected side. The treatment will be given by a qualified physiotherapist.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 54.0
Sex: All
Minimum age: 2 Years
Maximum age: 6 Years
Healthy volunteers: No
Keywords: flexibility; muscle; stretching; cerebral palsy; developmental

Summary:

      Children with developmental disabilities often sustain decreased range of motion in their
      extremities. The decrease in flexibility may be due to neuromuscular disorders such as
      spasticity or dystonia. Other causes may be imbalance in muscle strength surrounding a joint,
      leading to inappropriate habitual posture. Over time, muscle contracture may result for those
      muscle groups that are placed in a shortened position for an extended period of time. The
      most common site of muscle contractures among these children are gastrocnemius/soleus (lower
      limbs), and latissimus dorsi muscles (upper limbs). Muscle contractures can lead to further
      decline in functional abilities. Therefore, it is important to identify effective
      intervention strategies to enhance or maintain muscle flexibility in children with
      developmental dysfunctions.

      Commercially available endermotherapy device has been used to soften scar tissue following
      burn injuries. The mechanical stimulation applied may also have beneficial effects on
      relaxing the muscle tissue. The overall aim of the proposed study is to determine whether
      endermotherapy treatment has immediate effect in improving joint range of motion among
      children with developmental disabilities.

      The research hypothesis is that children in the endermotherapy group will have significantly
      more gain in ankle passive range of motion than those in the control group.
    

Eligibility criteria:

        Inclusion Criteria:

          -  children aged between 2 and 6.

          -  children with diagnosis of cerebral palsy or developmental disabilities.

          -  Has limited ankle dorsiflexion range of motion (less than 20 degrees)

        Exclusion Criteria:

          -  Other serious illnesses that preclude participation
Prostaglandin Inhibition for Emphysema
Condition: Emphysema
MeSH terms: Pulmonary Emphysema; Emphysema
Intervention: 600 mg ibuprofen three times daily for 48 weeks; Placebo three times daily
Intervention MeSH terms: Ibuprofen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 118.0
Sex: All
Minimum age: 46 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Emphysema; Prostaglandin E; Bronchoalveolar lavage

Summary:

      The Prostaglandin Inhibition for Emphysema (PIE) study will determine if a currently
      available therapy, ibuprofen 600 mg three times daily, can block PGE production in the lower
      respiratory tract and if this results in improvement in measures of lung repair function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 45 years

          -  Emphysema (>5% of voxels <950 Hounsfield Units determined on the CT scan performed as
             part of the COPDGene study as quantified at the COPDGene radiology center). An
             equivalent scan as determined by the radiology center is also acceptable.

          -  Post-bronchodilator FEV1 > 35% predicted)

          -  Smoker or ex-smoker (10 pack years minimum)

        Exclusion Criteria:

          -  Contraindication to bronchoscopy or other study procedures

          -  Pregnancy of plans to become pregnant within six months

          -  Aspirin-sensitive asthma

          -  Regular use of systemic glucocorticoid

          -  Regular use of an NSAID (low dose aspirin for cardiac disease is acceptable and
             subjects taking only this regularly will be eligible)

          -  Unstable medical condition

          -  History of myocardial infarction or unstable angina within six months

          -  Allergy to or history of adverse effect from ibuprofen or other NSAID

          -  History of gastrointestinal bleeding within one year

          -  Any condition that, in the opinion of the investigator, places the subject at untoward
             risk

          -  Inability to provide informed consent
Testing Mestinon and Exercise in Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: Exercise; pyridostigmine; Placibo; Attention Control
Intervention MeSH terms: Pyridostigmine Bromide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 178.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Fibromyalgia; Exercise; Mestinon

Summary:

      The purpose of this trial was to test the combined and independent effects of 6 months of
      exercise and Mestinon in people with fibromyalgia. Specifically, we wanted to determine if
      Mestinon helped people with fibromyalgia have an easier time exercising and if their symptoms
      improved by the end of the trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have Fibromyalgia

        Exclusion Criteria:

          -  Subjects will be excluded if they have a history of rheumatic disease or other
             disorder that may compromise ability to safely complete study protocol, be pregnant,
             nursing, or currently involved in unresolved litigation.
Efficacy And Safety Of Sofosbuvir/Velpatasvir Fixed Dose Combination With Ribavirin in Chronic HCV Infected Adults Who Participated in a Prior Gilead Sponsored HCV Treatment Study
Condition: Hepatitis C Virus Infection
MeSH terms: Hepatitis C
Intervention: SOF/VEL; RBV
Intervention description: 400/100 mg FDC tablet administered orally once daily; Tablet (s) administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Intervention MeSH terms: Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 69.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the efficacy, safety and tolerability of
      treatment with sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) with ribavirin (RBV) for 24 weeks
      in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead
      sponsored study and did not achieve sustained virologic response (SVR).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Willing and able to provide written informed consent

          -  HCV genotype determined by the Central Laboratory

          -  HCV RNA > LLOQ at screening

          -  Participated and completed a Gilead sponsored HCV treatment study of direct acting
             antiviral (DAA) containing regimens.

          -  Male and female of childbearing potential must agree to use protocol specified
             method(s) of contraception

        Key Exclusion Criteria:

          -  Current or prior history: Clinically-significant illness (other than HCV) or any other
             major medical disorder that may interfere with treatment, assessment or compliance
             with the protocol; individuals currently under evaluation for a potentially
             clinically-significant illness (other than HCV) are also excluded.

          -  Screening ECG with clinically significant abnormalities

          -  Laboratory results outside of acceptable ranges at screening

          -  Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

        NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
A Study for Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: LY2428757; Placebo
Intervention description: Once weekly for 12 weeks as a subcutaneous injection.; 1 of 5 volumes of placebo given once weekly for 12 weeks as a subcutaneous injection.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 247.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      A multicenter, multinational, randomized,double-blind, placebo-controlled study in patients
      with Type 2 Diabetes Mellitus (T2DM). Patients with inadequate glycemic control using diet
      and exercise alone, or in combination with metformin, will be enrolled. The primary objective
      of this study is to test the hypothesis that LY2428757 given to patients with T2DM
      inadequately controlled with diet and exercise alone, or metformin monotherapy, produces a
      significant decrease in the mean hemoglobin A1c (HbA1c) from baseline to endpoint at 12 weeks
      as compared to placebo. Trial consists of 12 weeks of double-blind treatment and 4-week
      safety follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have type 2 diabetes mellitus for at least 6 months prior to entering the trial.

          -  Treated with diet and exercise alone or in combination with at least 1000 milligrams
             (mg)/day of metformin for at least 2 months prior to screening.

          -  Have a glycosylated fraction of hemoglobin A (HbA1c) value of 7.0% - 10.0% at
             screening

          -  Women of child-bearing potential must test negative for pregnancy at screening and
             agree to abstain from heterosexual intercourse for the duration of the study, or use 2
             effective forms of birth control during the study.

          -  Have a body mass index (BMI) between 25 and 40 kilograms per square meters kg/m^2) at
             screening

          -  Stable weight during the 3 months prior to screening.

        Exclusion Criteria:

          -  Use any antidiabetic agent other than metformin during the 2 months prior to
             screening.

          -  Have a gastrointestinal disease that significantly impacts gastric emptying or
             motility or have undergone bariatric surgery.

          -  Are currently taking prescription or over-the counter medications to promote weight
             loss.

          -  Have been previously diagnosed with pancreatitis

          -  Women who are breastfeeding.

          -  Have a history of myocardial infarction, unstable angina, coronary artery bypass graft
             (CABG), percutaneous coronary intervention, transient ischemic attack, stroke or
             decompensated congestive heart failure in the past 6 months.

          -  Have poorly controlled hypertension
Safety Extension Study to Evaluate the Biodegradation of the Brimonidine Tartrate Posterior Segment Drug Delivery System
Condition: Patients Who Participated in an Intravitreal Brimo PS DDS® Study
Intervention: Brimo PS DDS®; Sham
Intervention description: Patients who received Brimo PS DDS® intravitreal implant in a previous study.; Patients who recieved sham in a previous study.
Phase: Phase 2
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Enrollment: 215.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the biodegradation of the brimonidine tartrate posterior segment
      drug delivery system.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Received the most recent sham or active study treatment of intravitreal Brimo PS DDS®
             no later than 36 months prior to entry into this study and have either completed their
             previous study, or have exited early from their previous study for any reason

          -  Applicable studies: Previous Allergan intravitreal Brimo PS DDS® treatment studies

        Exclusion Criteria:

        - None