bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess the Safety and Efficacy of ECF843 vs Vehicle in Subjects With Dry Eye Disease
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: ECF843; ECF843 vehicle
Intervention description: Topical ocular eye drop; Topical ocular eye drop
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Double-masked
Enrollment: 558.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dry Eye; Sjogrens; dry eye syndrome (DES); Keratoconjunctivitis sicca (KCS); keratitis; Xerophthalmia; Sjögren's Syndrome; Sjogren's Syndrome

Summary:

      The study was planned to be conducted in 2 parts: Part 1 to determine the efficacy and safety
      of ECF843 vs vehicle, followed by Part 2 with additional exploratory assessments of ECF843 vs
      Vehicle. Both parts of the study included a double-masked study design, with randomization
      stratified for subjects with Sjogren's Syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent must be obtained before any assessment

          -  Adult male or female subjects 18 years of age or older

          -  At least 6 months history of dry eye disease in both eyes

          -  Must use, or feel the need to use, artificial tears/gels/lubricants on a regular basis

          -  Composite corneal fluorescein staining score >= 4 (modified National Eye Institute
             (NEI) scale) in at least one eye

          -  Schirmer score >= 1 and =< 10 mm after 5 minutes in at least one eye

          -  Patients with Sjögren's Syndrome must have dry eye

        Exclusion Criteria:

          -  Ocular infection in either eye within 30 days prior to Screening

          -  Use of artificial tears, gels, lubricants within 4 hours of the Screening Visit

          -  Use of contact lenses in either eye within 14 days of Screening

          -  Uncontrolled ocular rosacea

          -  Clinically significant conjunctivochalasis in either eye

          -  Other Corneal conditions affecting the corneal structure

          -  Severe ocular conditions such as herpes, graft versus host disease, Stephen's Johnson
             Syndrome, sarcoidosis

          -  Currently active, or history of ocular allergies during the time of year the patient
             will be participating in the study

          -  Patients with current punctal plugs or punctal cauterization or occlusion

          -  Chronic medications (both over the counter and prescription) that have not been stable
             for at least 30 days prior to Screening.

          -  Use of Restasis®, Cequa®, or Xiidra® within 30 days prior to Screening

          -  Use of ocular, nasal, inhaled, or systemic corticosteroids within 30 days of Screening

          -  History of malignancy of any organ system within the past five years

          -  Pregnant or nursing women
A Dose Range Finding Study to Evaluate the Efficacy and Safety of AZD9668 Administered Orally at Three Dose Levels to Patients With Chronic Obstructive Pulmonary Disease (COPD) on Treatment With Tiotropium
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: AZD9668; AZD9668; AZD9668; AZD9668 Placebo
Intervention description: 2 x 30 mg oral tablets twice daily (bid) for 12 weeks; 2 x 10 mg oral tablets twice daily (bid) for 12 weeks; 2 x 2.5 mg oral tablets twice daily (bid) for 12 weeks; 2 x Matched placebo to oral tablet twice daily (bid) for 12 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 838.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Chronic; Obstructive; Pulmonary; Lung; Respiratory disease; Efficacy; Safety and tolerability; Placebo-controlled; Pharmacokinetics; COPD

Summary:

      The primary objective is to evaluate the dose-response relationship and efficacy of AZD9668
      at 3 dose levels compared with placebo in symptomatic COPD patients by assessing effects on
      lung function and symptoms of COPD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of COPD with symptoms over 1 year

          -  Smokers or ex-smokers

          -  Males or post-menopausal females between 40 and 80 years old

          -  Able to use electronic devices

        Exclusion Criteria:

          -  Past history or current evidence of clinically significant heart disease

          -  Current diagnosis of asthma

          -  Patients who require long term oxygen therapy

          -  Treatment with antibiotics within 4 weeks of study visit 1b
A Phase II Open Label Study of BMS-582664 in Locally Advanced or Metastatic Hepatocellular Cancer
Condition: Hepatocellular Carcinoma (HCC)
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: brivanib (active)
Intervention description: Tablet, Oral, Brivanib 800 mg, once daily, until progression
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 137.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this clinical research study is to learn if BMS-582664 can shrink or slow the
      growth of advanced liver cancer. The safety of this treatment will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of hepatocellular carcinoma (HCC) ≥ 2cm based on:

          -  Biopsy OR

          -  Radiological evidence of HCC by contrast-enhanced CT scan or contrast-enhanced AND

          -  Blood test positive for Hepatitis B or C AND

          -  Alpha fetoprotein above > 400 mg/L

          -  Not appropriate for curative surgery

          -  Screening Blood Pressure <150/100 mmHg, Left Ventricular Ejection Fraction (LVEF) >50%

        Exclusion Criteria:

          -  Heart Attack within 12 months, uncontrolled chest pain within 6 months

          -  Ascites resistant to diuretic medication therapy

          -  Portal-systemic encephalopathy

          -  Portal hypertension with bleeding esophageal or gastric varices within the past 2
             months

          -  Deficiency of sodium in the blood with sodium < 125 mEq/L

          -  Subjects with serious non-healing wounds, ulcers or bone fractures
Motexafin Gadolinium and Radiation Therapy in Treating Young Patients With Pontine Glioma
Condition: Untreated Childhood Brain Stem Glioma
MeSH terms: Glioma
Intervention: motexafin gadolinium; 3-dimensional conformal radiation therapy
Intervention description: Given IV; Undergo focal cranial radiotherapy
Intervention MeSH terms: Motexafin gadolinium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Maximum age: 21 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well giving motexafin gadolinium together with radiation
      therapy works in treating young patients with pontine glioma. Radiation therapy uses
      high-energy x-rays to kill tumor cells. Drugs, such as motexafin gadolinium, may make tumor
      cells more sensitive to radiation therapy. Giving motexafin gadolinium together with
      radiation therapy may kill more tumor cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of intrinsic pontine glioma (brain stem glioma)

               -  Clinical and radiographic (MRI) evidence of tumors that diffusely involve the
                  brain stem (i.e., tumors that intrinsically [> 50% intra-axial] involve the pons
                  or pons and medulla, pons and midbrain, or entire brain stem) allowed

               -  Tumor may contiguously involve the thalamus or upper cervical cord

               -  No more than 1 lesion/mass present at diagnosis

          -  Karnofsky performance status (PS) 60-100% (age > 16 years) OR Lansky PS 60-100% (age ≤
             16 years)

          -  Life expectancy ≥ 8 weeks

          -  Absolute neutrophil count ≥ 1,000/mm³

          -  Platelet count ≥ 100,000/mm³ (transfusion independent)

          -  Hemoglobin ≥ 10 g/dL (RBC transfusions allowed)

          -  Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR
             creatinine normal for age/gender (0.4-1.7 mg/dL)

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  ALT < 1.5 times ULN

          -  No known glucose-6-phosphate dehydrogenase (G6PD) deficiency

               -  If family history suggestive of congenital hemolytic anemia, patient must be
                  screened for G6PD with G6PD activity test prior to study entry

          -  No biliary obstruction

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No prior definitive therapy for this specific tumor

          -  No prior cranial radiotherapy

          -  Concurrent steroids and anticonvulsants allowed

          -  No concurrent proton therapy

          -  No concurrent intensity-modulated radiotherapy

          -  No concurrent anticancer chemotherapy

          -  No concurrent immunomodulating agents
A Study of the Safety and Efficacy of AGN-214868 in Patients With Postherpetic Neuralgia
Condition: Neuralgia, Postherpetic
MeSH terms: Neuralgia; Neuralgia, Postherpetic
Intervention: AGN-214868; Placebo to AGN-214868
Intervention description: AGN-214868 injected into areas of postherpetic neuralgia pain for total dose per treatment.; Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 294.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of AGN-214868 in patients with postherpetic
      neuralgia (PHN) - nerve pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Persistent postherpetic neuralgia (PHN) with nerve pain present for at least 9 months
             after onset of herpes zoster skin rash

        Exclusion Criteria:

          -  Female patients with reproductive potential

          -  Active herpes zoster skin rash

          -  Current or anticipated treatment with acupuncture, TNS, or steroids

          -  Current or anticipated use of topical analgesic agents with PHN

          -  Treatment with botulinum toxin therapy of any serotype within the prior 12 weeks
Exemestane in Combination With Fulvestrant in Postmenopausal Women With Hormone Sensitive Advanced Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Exemestane; Fulvestrant
Intervention description: 25 mg orally per day; 250 mg IM starting on Day 8 and then every 28 days.
Intervention MeSH terms: Fulvestrant; Exemestane
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Postmenopausal; Women

Summary:

      The purpose of this trial is to evaluate time to progression in women with hormone responsive
      advanced breast cancer treated with a combination of exemestane and fulvestrant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Proven breast cancer

          -  Metastatic or locally advanced breast cancer

          -  Hormonally responsive disease defined as estrogen (ER) and/ or progesterone receptor
             (PR) positive (>10% staining by immunohistochemistry)

          -  Postmenopausal status

          -  No more than 1 prior chemotherapy for stage IV metastatic breast cancer allowed

          -  ECOG (Eastern Cooperative Oncology Group) performance status 0-2

          -  Adequate organ function

          -  Exclusion Criteria:

          -  No prior Exemestane or Fulvestrant

          -  Uncontrolled intercurrent illness including but not limited to:

               -  ongoing or active infection

               -  symptomatic congestive heart failure

               -  unstable angina pectoris

               -  cardiac arrhythmia

               -  myocardial infarction within the last 3 months

               -  psychiatric illness/social situations that would limit compliance with study

          -  Lymphangitic pulmonary disease; carcinomatous meningitis, bone marrow only metastases;
             and a rising tumor marker without any other site of metastatic disease.

          -  Presence of bleeding diathesis or coagulopathy, patients requiring coumadin
BI 207127 / Faldaprevir Combination Therapy in Hepatic Impairment (Child-Pugh B) Patients With Genotype 1b Chronic Hepatitis C Infection: HCVerso3
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Ribavirin; BI 207127 high dose; Faldaprevir; Ribavirin; BI 207127 low dose; Faldaprevir
Intervention description: 24 Weeks; 24 Weeks; 24 Weeks; 24 Weeks; 24 Weeks; 24 Weeks
Intervention MeSH terms: Ribavirin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      To assess the pharmacokenetic characteristics of 600 mg BID BI 207127 / 120 mg QD faldaprevir
      /ribavirin in a small number of GT1b HCV infected patients with mild hepatic impairment (CPA)
      (Arm 1) versus 400 mg BID BI 207127 / 120 mg QD faldaprevir /ribavirin in a small number of
      GT1b HCV infected patients with moderate hepatic impairment (CPB) (Arm 2).
    

Eligibility criteria:

        Inclusion criteria:

          1. Treatment naïve and treatment experienced patients (prior relapse, interferon
             intolerant, and [allowed in Cohort A only] prior partial response).

          2. Chronic HCV infection of genotype 1 (GT1), sub-GT1b virus only.

          3. Liver cirrhosis defined as Metavir Grade=4 or Ishak Grade =5 on liver biopsy or liver
             stiffness of =13 kPa on fibroscan.

        Exclusion criteria:

          1. HCV infection of mixed genotype (1/2, 1/3, and 1/4) or mixed sub-GT1a/1b or undefined
             diagnosed by genotypic testing at screening

          2. Liver disease due to causes other than chronic HCV infection which may include but is
             not limited to hemochromatosis, Wilson's disease, or autoimmune liver diseases.

          3. HIV infection

          4. Patients who have been previously treated with an investigational or approved DAA
A Comparison of EpiCept™ NP-1 Topical Cream vs. Oral Gabapentin in Postherpetic Neuralgia (PHN)
Condition: Post Herpetic Neuralgia; PHN; Neuropathy; Nerve Pain
MeSH terms: Neuralgia; Neuralgia, Postherpetic
Intervention: EpiCept-NP-1 Cream; Gabapentin Capsules; placebo
Intervention description: ketamine 4% amitriptyline 2% cream, twice daily for 4 weeks; 1800mg/day capsules for 4 weeks; placebo cream and caps
Intervention MeSH terms: Gabapentin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 360.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Post Herpetic Neuralgia; PHN; Neuropathy; Nerve Pain; Topical

Summary:

      The purpose of this study is to compare EpiCept™ NP-1 Topical Cream (2% ketamine / 4%
      amitriptyline) vs. Oral Gabapentin in the treatment of Postherpetic Neuralgia (PHN)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients with pain for ≥ 3 months following onset of a herpes zoster rash

        Exclusion Criteria:

          -  Clinically significant intercurrent illness (e.g., endocrine, cardiac, hepatic, renal,
             neurologic, hematologic, skeletal) that the investigator determines could interfere
             with the efficacy or safety assessments.
Brexpiprazole in Borderline Personality Disorder
Condition: Borderline Personality Disorder
MeSH terms: Personality Disorders; Borderline Personality Disorder
Intervention: Rexulti; Placebo
Intervention description: Atypical antipsychotic; Pill that contains no medicine
Intervention MeSH terms: Brexpiprazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The primary objective of the proposed study is to evaluate the safety and efficacy of
      Brexpiprazole in adults with borderline personality disorder (BPD). The hypothesis to be
      tested is that brexpiprazole will be more effective and well tolerated in adults with BPD
      compared to placebo. The proposed study will provide needed data on the treatment of a
      disabling disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men and women age 18-65;

          2. Primary diagnosis of BPD

          3. Zanarini scale score of at least 9 at baseline

          4. Ability to understand and sign the consent form.

        Exclusion Criteria:

          1. Unstable medical illness based on history or clinically significant abnormalities on
             baseline physical examination

          2. Subjects with schizophrenia or bipolar I disorder

          3. Subjects with an active substance use disorder

          4. Current pregnancy or lactation, or inadequate contraception in women of childbearing
             potential

          5. Subjects considered an immediate suicide risk based on the Columbia Suicide Severity
             rating Scale (C-SSRS) (www.cssrs.columbia.edu/docs)

          6. Illegal substance use based on urine toxicology screening

          7. Initiation of psychological interventions within 3 months of screening

          8. Use of any other psychotropic medication

          9. Previous treatment with Brexpiprazole

         10. Cognitive impairment that interferes with the capacity to understand and
             self-administer medication or provide written informed consent
Evaluation of the Quality of Life Questionnaire-Bronchiectasis (QOL-B) in Patients With Bronchiectasis
Condition: Bronchiectasis
MeSH terms: Bronchiectasis
Intervention: AZLI
Intervention description: 75 mg aztreonam for inhalation solution (AZLI), administered 3 times daily using the PARI Investigational eFlow® Nebulizer System (with a minimum of 4 hours between doses) following administration of a short-acting bronchodilator
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 89.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Over the 70-day study period, eligible patients visited the study clinic every 2 weeks (total
      of 6 visits) and received a 28-day course of aztreonam for inhalation solution (AZLI). The
      Quality of Life-Bronchiectasis (QOL-B) questionnaire was completed at several time points
      during the study, in additional to pulmonary function testing and other standard procedures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent prior to any study-related procedures

          -  Ability to read and understand the English language

          -  Bronchiectasis confirmed by CT scan of the chest

          -  Previous treatment with antibiotics for bronchiectasis

          -  Documented history of positive sputum culture for a gram-negative organism within 5
             years

          -  Positive sputum culture for a gram-negative organism at first visit (Day -14)

        Exclusion Criteria:

          -  Hospitalization or hemoptysis > 30 mL within 14 days of first visit (Day -14)

          -  Antibiotic use for respiratory symptoms within 14 days of first visit (Day -14),
             excluding chronic, stable azithromycin use

          -  Change in corticosteroid or bronchodilator regimen within 14 days of first visit (Day
             -14)

          -  Forced expiratory volume in 1 second (FEV1) < 25% predicted approximately 15 minutes
             following use of a bronchodilator at first visit (Day -14)

          -  Cigarette smoking within 6 months of first visit (Day -14)
Study of PRO 140 by Subcutaneous Administration in Adult Subjects With HIV -1 Infection
Condition: HIV -1 Infection; HIV Infections
MeSH terms: Infections; Communicable Diseases
Intervention: PRO 140 (humanized monoclonal antibody to CCR5); Placebo Comparator
Intervention MeSH terms: Leronlimab; Antibodies; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV; Treatment Naïve

Summary:

      The purpose of this study is:

        1. To assess the antiviral activity of PRO 140

        2. To assess the safety and tolerability of PRO 140

        3. To generate additional PK, PD and safety data of PRO 140
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males & females, age ≥ 18 years (or minimum adult age as determined by local
             regulatory authorities)

          2. Screening plasma HIV-1 RNA ≥ 5,000 copies/mL

          3. CD4+ lymphocyte cell count ≥ 300 cells/mm3 and no documented count < or = 250
             cells/mm3

          4. Has not taken any antiretroviral therapy (ART) w/in 12 wks of Early Screening Visit

          5. Exclusive CCR5-tropic virus as determined by Trofile™ Assay at Early Screening Visit

          6. Clinically normal or "not clinically significant (NCS)" resting electrocardiogram

          7. Women of reproductive potential must have a negative serum pregnancy test at Late
             Screening Visit & a negative urine pregnancy test w/in 72 hrs prior to first dose of
             study medication, & be non-lactating. Male & female subjects must agree not to
             participate in a conception process from Early Screening Visit through Day 59.

        Exclusion Criteria:

          1. CXCR4 tropic virus or dual/mixed tropic (R5X4) virus determined by the Trofile™ Assay.

          2. Females who are pregnant, lactating or breastfeeding, or who plan to become pregnant
             during the study.

          3. History of active hepatitis within the previous 24 wks

          4. Prior use of any entry, attachment, CCR5 co-receptor or fusion inhibitor, including
             PRO 140, experimental or approved.

          5. Any immunization or vaccination (including influenza vaccine) within 30 days prior to
             administration of study drug.