bioihbjkbjnl/mcl2 huggingface dataset:
A Study of SB-742457, Added to Donepezil for the Treatment of Mild-to-moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: SB-742457 15mg; SB-742457 35mg; Placebo; donepezil 5-10mg
Intervention description: SB-742457 - 15mg added to existing donepezil treatment; SB-742457 - 35mg added to existing donepezil; Placebo added to existing donepezil; existing donepezil treatment
Intervention MeSH terms: Donepezil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 682.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Alzheimer's disease cognition SB-742457

Summary:

      The study is designed to investigate the safety and efficacy of SB-742457 when added to
      stable donepezil treatment in subjects with mild-to-moderate Alzheimer's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects and their caregivers must provide informed consent prior to study entry.

          -  Subjects must have a clinical diagnosis of probable mild-to-moderate Alzheimer's
             disease with no evidence of disorders that are thought to be the cause of, or
             contributing to the severity of the subject's dementia and a documented history of at
             least 6 months of ongoing donepezil therapy with stable dosing for at least the last 2
             months.

          -  Subjects must have a regular caregiver who is willing to attend visits, oversee the
             subject's compliance with the study and report on the subject's status.

          -  Female subjects of child-bearing potential must agree to abstinence or an approved
             form of birth control.

          -  Subjects must have adequate blood pressure and laboratory values.

        Exclusion Criteria:

          -  Subjects with a diagnosis of possible, probable or definite vascular dementia may not
             participate.

          -  Subjects with known hypersensitivity to sunlight or a history of seizures, previous
             exposure to SB-742457, taking agents for which there is a theoretical risk of
             interaction with SB-742457, or taking medication for Alzheimer's disease or centrally
             acting agents which might impact study outcomes may not participate.
Docetaxel in Treating Patients With Relapsed Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: docetaxel
Intervention description: Docetaxel 75 mg/m2 intravenously (IV) over 60 minutes will be given on day 1 of each 21 day cycle.
Intervention MeSH terms: Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the prostate; recurrent prostate cancer; stage I prostate cancer; stage II prostate cancer; stage III prostate cancer; stage IV prostate cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the
      growth of tumor cells, either by killing the cells or by stopping them from dividing.

      PURPOSE: This phase II trial is studying how well docetaxel works in treating patients with
      relapsed prostate cancer.
    

Eligibility criteria:

        Criteria for Patient eligibility

        Inclusion criteria

          1. Histologically confirmed adenocarcinoma of the prostate.

          2. Prior primary therapy for prostate cancer, including radical prostatectomy, external
             beam radiation therapy, or brachytherapy.

          3. Serum PSA > 0.2 ng/dL following 8 months of androgen deprivation therapy or a nadir
             PSA >0.2 ng/dL and at least 1 subsequent PSA values at the same or higher level, if
             prior to 8 months.

          4. Serum testosterone < 50 ng/ml.

          5. No evidence of metastases on bone scan.

          6. No evidence of metastases on CT scan of the abdomen and pelvis.

          7. ECOG performance status < 2.

          8. Laboratory criteria for entry: absolute neutrophil count ≥ 1.2 K/cu mm, platelets ≥
             100 K/cu mm, serum bilirubin ≤ upper limit of normal (ULN), SGOT and SGPT ≤ 1.5 times
             institutional ULN if alkaline phosphatase ≤ ULN, alkaline phosphatase ≤ 5 times ULN if
             SGOT and SGPT are ≤ ULN, a serum creatinine ≤ 2 times institutional ULN.

          9. Signed informed consent.

        Exclusion Criteria

          1. A second active malignancy during the last 5 years, except adequately treated
             non-melanoma skin cancer.

          2. Life expectancy < 3 months.

          3. Grade 2 or higher peripheral neuropathy.

          4. Prior investigational agent within the past 28 days.

          5. Less than a 10% decrease (or continued rise) in PSA in response to initial
             androgen-deprivation therapy.

          6. More than 12 months since initiation of androgen-deprivation therapy.

          7. Prior docetaxel chemotherapy.

          8. Patients recently (within 28 days) started on corticosteroids, with the exception of
             inhaled and topical steroids. Patients on stable doses of systemic corticosteroids
             will be eligible.
14729-D9831C00002- 1 Month Biopsy Study
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: AZD1981; Placebo
Intervention description: Oral tablet, twice daily, 4 weeks treatment; 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: 52.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; Moderate to severe COPD

Summary:

      The purpose of this study is to study histological changes, cellularity, clinical efficacy
      and safety of AZD1981 in patients with Chronic Obstructive Pulmonary Disease
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women 40 years or above

          -  FEV1 between 40 and 80% of predicted normal value post-bronchodilator

          -  Clinical diagnosis of COPD

        Exclusion Criteria:

          -  Other clinically relevant disease or disorders

          -  Exacerbation of COPD within 30 days
A Long-Term Study of Rovalpituzumab Tesirine
Condition: Cancer
Intervention: rovalpituzumab tesirine; rovalpituzumab tesirine
Intervention description: Optional retreatment with rovalpituzumab tesirine (0.3 mg/kg or previously adjusted dose) administered intravenously once every 6 weeks beginning on Day 1 (day of dosing) for 2 dose cycles; Rovalpituzumab tesirine (0.3 mg/kg or previously adjusted dose) administered intravenously once every 6 weeks beginning on Day 1 (day of dosing). Subjects will receive rovalpituzumab tesirine on Day 1 of each 6-week cycle, omitting every third cycle until disease progression or study drug discontinuation.
Intervention MeSH terms: Rovalpituzumab tesirine; Immunoconjugates
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: rovalpituzumab tesirine; rollover study; cancer

Summary:

      The purpose of this long-term, extension study is to provide ongoing safety and efficacy
      follow-up of subjects who participated in a rovalpituzumab tesirine study that has completed
      the primary analysis and that is closing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject had enrolled, participated in, and received at least 1 dose of rovalpituzumab
             tesirine in a parent study.

          -  Additional eligibility criterion for Arm A: subjects who discontinued the study drug
             in the parent study have completed the treatment emergent adverse event reporting
             window.

        For subjects who elect optional retreatment in Arm A, must meet additional criteria before
        receiving rovalpituzumab tesirine retreatment including:

          -  Tolerated their initial 2 doses of rovalpituzumab tesirine.

          -  Achieved clinical benefit as defined by stable disease or better, and is determined
             that the subject would potentially benefit from additional treatment.

          -  Experienced radiographic disease progression at least 12 weeks after the second dose
             of rovalpituzumab tesirine.

          -  Received no other systemic anti-cancer therapy after rovalpituzumab tesirine
             treatment.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

          -  Adequate hematologic, kidney, and liver function, per protocol.

          -  In subjects with central nervous system (CNS) metastases, documentation of stable or
             improved status as described in the protocol.

        Exclusion Criteria:

          -  Subjects not previously enrolled in a rovalpituzumab tesirine study.
Colchicine and CRP in Atrial Fibrillation and AF Ablation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Colchicine, 0.6 mg PO BID; Matching placebo
Intervention description: Colchicine tablets will be over-encapsulated by the research pharmacy to be indistinguishable from placebo; Matching placebo tablets will be encapsulated by the research pharmacy to be indistinguishable from active drug
Intervention MeSH terms: Colchicine
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: 21 Years
Healthy volunteers: No
Keywords: atrial fibrillation; catheter ablation; colchicine; c reactive protein; CRP

Summary:

      Colchicine will lower C-reactive protein (CRP) in chronic atrial fibrillation and reduce the
      rise in CRP which occurs following atrial fibrillation ablation
    

Eligibility criteria:

        Inclusion Criteria:

          -  Group 1: Persistent or chronic AF presenting for evaluation in cardiology offices.
             Diagnosis of AF will be made based on the 12 -lead surface ECG.

          -  Group 2: Paroxysmal AF scheduled to go AF ablation presenting to the electrophysiology
             laboratory for the procedure in sinus rhythm..

          -  Group 3:Chronic AF scheduled to go clinically indicated AF ablation, and presenting in
             the electrophysiology laboratory in atrial fibrillation .

        Exclusion Criteria:

          1. Abnormal liver function with elevated enzymes> 1.5 times the normal.

          2. Abnormal kidney function with glomerular filtration rate < 50 ml/min

          3. Increased levels of creatine kinase or known myopathy

          4. Neutropenia

          5. Known GI disorders

          6. Women of childbearing age who have not had surgical sterilization and are not using
             oral contraceptives, or who's spouse has not had surgical sterilization will be
             excluded due to the length of the trial and the possibility that they could become
             pregnant after entry.

          7. Pregnant and lactating women

          8. Lactose intolerance

          9. Known sensitivity, allergy, or contraindication to colchicine use
Antiplatelet Therapy in HIV
Condition: HIV; Cardiovascular Diseases; Inflammation
MeSH terms: Cardiovascular Diseases; Inflammation
Intervention: Aspirin; Clopidogrel
Intervention MeSH terms: Aspirin; Clopidogrel
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 55.0
Sex: All
Minimum age: 21 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The proposed study will add to the growing understanding of platelet activity and platelet
      inhibition in subjects with HIV. It will examine the relationship between platelet activity
      and its inhibition by antiplatelet therapy (aspirin monotherapy and clopidogrel monotherapy)
      in this high-risk cohort. Furthermore, it will provide important data on the mechanism of
      platelet activity and its inhibition using biomarkers of platelet activity, inflammation,
      immune activity and endothelial function and genetic expression profiling.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV infection

          -  Current Antiretroviral Therapy with no change in regimen in the 12 weeks prior to
             study entry and no plans to change ART for the study duration

          -  Ability to sign consent and comply with the protocol

        Exclusion Criteria:

          -  Known CD4+ T cell counts < 200 cells/mm3 during the 6 months prior to study entry

          -  Established cardiovascular disease (thereby necessitating antiplatelet therapy)

          -  NSAID use in the past week (including aspirin)

          -  Unable to be off NSAIDs for the duration of the trial

          -  Any antiplatelet or antithrombotic use

          -  Allergy to aspirin or clopidogrel

          -  Pregnancy

          -  Chronic kidney disease (GFR<45 ml/min)

          -  AIDS

          -  Active drug or alcohol use that would interfere with adherence to study requirements

          -  Any known bleeding disorder

          -  Use of regularly prescribed medication such as steroids, or immunosuppressive agents

          -  Known anemia (Hb <8mg/dL)

          -  Thrombocytopenia (platelet count <75) or thrombocytosis (Platelet count >600)
BOTOX® Efficacy and Safety in the Treatment of Knee Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: onabotulinumtoxinA; Normal Saline
Intervention description: onabotulinumtoxinA (botulinum toxin Type A) injection into the intra-articular space of the study knee.; Normal Saline (placebo) injection into the intra-articular space of the study knee.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 176.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of a single intra-articular injection of 2
      doses of BOTOX® (onabotulinumtoxinA) compared with placebo as treatment for knee
      osteoarthritis symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Painful osteoarthritis

          -  Able to discontinue anti-inflammatory drugs and analgesics

          -  Must be ambulatory without assistive walking devices

        Exclusion Criteria:

          -  Chronic pain conditions other than knee osteoarthritis

          -  Treatment with corticosteroids in the study knee within 12 weeks

          -  Treatment with hyaluronic acid in the study knee within 24 weeks

          -  Previous treatment with any botulinum toxin for any reason

          -  Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral
             sclerosis
Dose-range Finding Efficacy and Safety Study for QBW251 in COPD Patients
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Intervention: QBW251; Placebo; COPD maintenance background therapy
Intervention description: QBW251 oral capsules (450, 300, 150, 75 and 25 mg) of identical appearance to ensure blinding administered twice a day (b.i.d) for 24 weeks; Placebo oral capsules administered twice a day for 24 weeks; Combination of fluticasone furoate, vilanterol and umeclidinium bromide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 974.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD

Summary:

      This clinical study was designed to support the dose selection for future studies by
      evaluating efficacy and safety of different QBW251 doses in Chronic obstructive pulmonary
      disease (COPD) patients with chronic bronchitis and a history of exacerbations, compared to
      placebo, when added to a triple inhaled therapy of LABA, LAMA and ICS.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female COPD patients aged ≥40 years, who have signed an Informed Consent Form
             prior to initiation of any study-related procedure.

          -  Current or ex-smokers who have a smoking history of at least 10 pack years.

          -  Patients who have been treated with a triple combination of LABA/LAMA/ICS for the last
             3 months prior to screening.

          -  Patients featuring chronic bronchitis

        Exclusion Criteria:

          -  Patients who have had a COPD exacerbation that required treatment with antibiotics
             and/or oral corticosteroids and/or hospitalization, or a respiratory tract infection
             in the 4 weeks prior to screening, or between screening and randomization.

          -  Patients with any documented history of asthma, or with an onset of chronic
             respiratory symptoms, including a COPD diagnosis, prior to age 40 years.

          -  Patients with a body mass index (BMI) of more than 40 kg/m2.

          -  Use of other investigational drugs (approved or unapproved) within 30 days or 5
             half-lives prior to screening, or until the expected pharmacodynamic effect has
             returned to baseline (e.g., biologics), whichever is longer; or longer if required by
             local regulations.

          -  Pregnant or nursing (lactating) women, and women of childbearing potential not willing
             to use acceptable effective methods of contraception during study participation.
Explorative Trial Evaluating the Efficacy and Tolerability of LEO43204 in Moderate to Severe Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: LEO43204; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: No

Summary:

      An exploratory Phase 2, single, centre, prospective, randomized, placebo-controlled,
      double-blinded, split-pace (left/right) design trial to evaluate the efficacy and
      tolerability of LEO 43204 in adults with moderate to severe acne.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects should be diagnosed with acne vulgaris of the face

          -  Fitzpatrick skin types I-III (due to lack of safety data for the investigational
             product in darker skin types)

          -  Disease severity and total lesion count should be similar in both TAs

          -  Disease severity grade as moderate to severe according to the investigator's global
             assessment (grade 3-4)

          -  Age 18 to 35 years incl.

          -  Male or female

          -  Female Subjects must be of either non-childbearing potential or child-bearing
             potential with a confirmed negative pregnancy test

        Exclusion Criteria:

          -  Subjects with nodulocystic acne, acne conglobata, acne fulminans, secondary acne (e.g.
             chlor-acne, drug-induced acne)

          -  Subjects with previous history of keloid formation or post-inflammatory
             hyperpigmentation

          -  Systemic retinoids within 12 month or systemic antibiotics within 1 month before Day 1

          -  Topical retinoids within 3 months before Day 1 or other topical treatments and/or
             medicated products and cosmetics that in the opinion of the investigator may influence
             the subjects acne vulgaris (including soaps containing antibacterial agents such as
             benzoyl peroxide, keratinolytic agents such as salicylic acid, skin
             fresheners/astringents or aftershave products) within 1 month before Day 1
Safety and Efficacy of Three Formulations of AGN-210669 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution
Condition: Glaucoma, Open-Angle; Ocular Hypertension
MeSH terms: Ocular Hypertension; Glaucoma, Open-Angle
Intervention: AGN-210669 ophthalmic solution, 0.1%; AGN-210669 ophthalmic solution, 0.075%; AGN-210669 ophthalmic solution, 0.05%; bimatoprost ophthalmic solution 0.03%
Intervention description: One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.; One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.; One drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.; One drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
Intervention MeSH terms: Bimatoprost; 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: 165.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety, efficacy and dose-response of AGN-210669. This study
      will also compare AGN-210669 with bimatoprost ophthalmic solution (LUMIGAN®).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ocular hypertension or primary open-angle glaucoma in each eye

          -  Patient requires IOP lowering medication in each eye

        Exclusion Criteria:

          -  Ocular hyperemia or other ocular surface findings in either eye

          -  Active ocular disease

          -  Current or anticipated use of any topical ocular medication (including artificial
             tears) during the study

          -  Intraocular surgery within past six months or unilateral cataract surgery.

          -  Functionally significant visual field loss

          -  Anticipated wearing of contact lenses during study

          -  Use of other medications that affect IOP such as glaucoma treating medications, within
             2 months of screening visit