bioihbjkbjnl/mcl2 huggingface dataset:
A Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis (Study 306)
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: 122-0551 Foam; Vehicle Foam
Intervention description: Topical Foam; Topical Foam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 151.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This Phase 3 study (Study 306) has been designed to determine and compare the efficacy and
      safety of 122-0551 Foam and Vehicle Foam applied twice daily for two weeks in subjects with
      plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 2%
             and no more than 12% affected body surface area.

          -  Subject has an Investigator's Global Assessment (IGA) score of at least three
             (moderate) at study start.

          -  If subject is a woman of childbearing potential, she must have a negative urine
             pregnancy test and agree to use an effective form of birth control for the duration of
             the study.

        Exclusion Criteria:

          -  Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.

          -  Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis.

          -  Subject has a physical condition which, in the investigator's opinion, might impair
             evaluation of plaque psoriasis, or which exposes the subject to an unacceptable risk
             by study participation.

          -  Subject has used any phototherapy (including laser), photo-chemotherapy or other forms
             of photo based therapy for the treatment of their psoriasis within 30 days prior to
             study start.

          -  Subject has used any systemic methotrexate, retinoids, systemic corticosteroids
             [including intralesional, intra-articular, and intramuscular corticosteroids],
             cyclosporine or analogous products within 90 days prior to study start.

          -  Subject has used any systemic biologic therapy (i.e., FDA-approved or experimental
             therapy) within five half-lives of the biologic prior to study start.

          -  Subject had prolonged exposure to natural or artificial sources of ultraviolet
             radiation within 30 days prior to study start or is intending to have such exposure
             during the study.
Vaspect Study - An Open-Label Trial Of Donepezil in Vascular and Mixed Dementia
Condition: Dementia, Vascular; Dementia, Mixed
MeSH terms: Dementia; Alzheimer Disease; Dementia, Vascular; Mixed Dementias
Intervention: Donepezil
Intervention description: donepezil 5mg/day for 6 weeks and then 5 to 10mg/day for 18 weeks
Intervention MeSH terms: Donepezil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 149.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      To document effectiveness, safety, and tolerability of donepezil in patients with mixed
      AD/VaD, and to further document the effectiveness, safety, and tolerability of donepezil in
      patients with VaD. The effects of donepezil on executive functioning, behavior, general
      cognition, ADLs and global functioning will be assessed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must meet DSM-IV-TR criteria for the clinical diagnosis of Vascular Dementia
             or the clinical diagnosis of dementia due to multiple etiologies.

          -  Subjects must have a reliable caregiver or family member who agrees to accompany the
             subject to all scheduled visits, provide information about the subject as required.

        Exclusion Criteria:

          -  Subjects with any current primary psychiatric diagnosis other than dementia of the
             Alzheimer's type or Vascular Dementia.
Efficacy/Safety of Verteporfin Photodynamic Therapy and Ranibizumab Compared With Ranibizumab in Patients With Subfoveal Choroidal Neovascularization
Condition: Macular Degeneration; Choroidal Neovascularization
MeSH terms: Macular Degeneration; Choroidal Neovascularization; Neovascularization, Pathologic
Intervention: Verteporfin Photodynamic Therapy; Ranibizumab; Verteporfin Placebo; Ranibizumab Placebo
Intervention description: After a 10-minute intravenous infusion of verteporfin at a dose of 6 mg/m^2 body surface area, verteporfin was activated by light application of 50 J/cm^2 (Standard Fluence rate) or 25 J/cm^2 (Reduced Fluence rate) to the study eye, begun 15 minutes after the start of the infusion.; Ranibizumab 0.5 mg administered as an intravitreal injection.; To maintain masking, as a placebo for verteporfin photodynamic therapy, patients were administered a 10-minute intravenous infusion of 5% dextrose solution, followed by light application of 50 J/cm^2 to the study eye, begun 15 minutes after the start of infusion.; To maintain masking, patients in the combination groups received sham intravitreal injections whenever retreatment with active Ranibizumab was not warranted based on the retreatment algorithm.
Intervention MeSH terms: Ranibizumab; Verteporfin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 321.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Age-related macular degeneration; AMD; choroidal neovascularization; verteporfin; ranibizumab

Summary:

      This study evaluated the effect of combination therapy with verteporfin photodynamic therapy
      and ranibizumab on visual acuity and anatomic outcomes compared to ranibizumab monotherapy
      and the durability of response observed in patients with choroidal neovascularization
      secondary to age-related macular degeneration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects of either gender age 50 years or older

          -  Subfoveal choroidal neovascularization (CNV) due to age-related macular degeneration
             (AMD)

        Exclusion Criteria:

          -  Choroidal neovascularization due to causes other than AMD

          -  Prior treatment for neovascular AMD in the study eye

        Other protocol-defined inclusion/exclusion criteria may apply
E3810-A001-313: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers
Condition: Heartburn
MeSH terms: Heartburn
Intervention: rabeprazole sodium; Placebo
Intervention description: Following a one week single-blind, placebo run-in phase, patients will receive rabeprazole 10 mg orally, once daily, for 14 days during the double-blind, randomized treatment phase. This will be followed by a one week single-blind placebo follow-up phase.; Following a one week single-blind, placebo run-in phase, patients will receive placebo orally, once daily, for 14 days during the double-blind, randomized treatment phase. This will be followed by a one week single-blind placebo follow-up phase.
Intervention MeSH terms: Rabeprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 629.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate the safety and efficacy of rabeprazole sodium 10
      mg in treating frequent heartburn.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female patients > 18 years of age.

          2. If female, not of childbearing potential by reason of surgery or menopause, or of
             childbearing potential, but using an approved method of contraception since the last
             menstrual period. Females of childbearing potential must have a negative serum
             pregnancy test before starting the study.

          3. Patients must report a history of heartburn at least two days per week over the past
             month.

        Exclusion Criteria:

          1. History of erosive esophagitis verified by endoscopy.

          2. History of gastroesophageal reflux disease (GERD) diagnosed by a physician.

          3. Patients who have a history of Barrett's esophagus or esophageal stricture.

          4. Evidence of any medical condition that may interfere with the conduct of the study,
             the interpretation of study results, or the health of the patient during the study.

          5. Patients who require continuous use of proton pump inhibitors, histamine receptor (H2)
             blockers, or prokinetics. Prior intermittent use of these agents is permitted if they
             are discontinued at least three days prior to the run-in phase. The H2 blocker,
             cimetidine (Tagamet®), must be discontinued for at least seven days before the study
             drug is administered.
Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) Versus Placebo in Peri- and Postmenopausal Women
Condition: Depression; Depressive Disorder; Depressive Disorder, Major
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Intervention: Desvenlafaxine administered as a succinate salt in a sustained-release form (DVS SR); Placebo
Intervention description: DVS-SR 50-200mg, daily (QD), tablet form, treatment period up to 34 weeks; Placebo, daily (QD), tablet form, treatment period up to 8 weeks
Intervention MeSH terms: Desvenlafaxine Succinate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 381.0
Sex: Female
Minimum age: 40 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder; vasomotor symptoms; menopause; diabetic neuropathy; fibromyalgia

Summary:

      Desvenlafaxine succinate (DVS) is a potent and selective serotonin and norepinephrine
      reuptake inhibitor (SNRI). The sustained-release (SR) formulation, DVS SR, is being studied
      in the development program for the treatment of major depressive disorder (MDD), for
      vasomotor symptoms (VMS) associated with menopause, and for pain associated with peripheral
      diabetic neuropathy, as well as for the treatment of fibromyalgia syndrome. This study will
      investigate the safety, efficacy, and tolerability of DVS SR in women with MDD who are peri-
      and postmenopausal.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Peri- and postmenopausal women between the ages of 40 and 70 years, inclusive.

          -  A primary diagnosis of MDD, single or recurrent episode, without psychotic features
             using the modified International Neuropsychiatric Interview (MINI).

          -  Montgomery-Asberg Depression Rating Scale (MADRS) total score > or = 22 at the
             screening and baseline visit.

        Exclusion Criteria:

          -  Use of oral estrogen-, progestin-, androgen-, or Selective Estrogen Receptor Modulator
             (SERM)-containing drug products 8 weeks before baseline.

          -  Current (within 12 months) psychoactive substance abuse or dependence (including
             alcohol), manic episode, post-traumatic stress disorder, obsessive-compulsive
             disorder, or a lifetime diagnosis of bipolar or psychotic disorder.

          -  A history or active presence of clinically important medical disease.

        Additional criteria apply.
MK0431A Comparative Study in Patients With Type 2 Diabetes (0431A-079)(COMPLETED)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: sitagliptin phosphate (+) metformin hydrochloride; metformin
Intervention description: sitagliptin/Metformin HCl 50/500 mg tablet bid, titrating up to sitagliptin/Metformin HCl 50/1000 mg tablet over 4 weeks; for a 44-wk treatment period.; metformin 500 mg tablet bid, titrating up to 1000 mg tablets bid for a 44-wk treatment period
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1246.0
Sex: All
Minimum age: 18 Years
Maximum age: 78 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate the efficacy and safety of an investigational
      treatment for type 2 diabetes mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has type 2 diabetes mellitus

          -  Patient is greater than or equal to 18 and less than or equal to 78 years of age on
             the day of signing the consent

          -  Patient has Hb1Ac greater than or equal to 7.5% and is appropriate for oral therapy

          -  Patient has not been on any antihyperglycemic agent (AHA) in the last 4 months

          -  Patient is a male, or a female who is unlikely to conceive

        Exclusion Criteria:

          -  Patient has type 1 diabetes mellitus or history of ketoacidosis
Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women in North America
Condition: Sexual Dysfunctions, Psychological
MeSH terms: Sexual Dysfunctions, Psychological
Intervention: Flibanserin; Placebo
Intervention description: Flibanserin 100mg administered at bedtime for 24 weeks; This is the matched placebo which will be administered two tablets daily at bedtime.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 748.0
Sex: Female
Minimum age: 35 Years
Healthy volunteers: No

Summary:

      The objective of this trial is to assess the safety and efficacy of 24-week course of
      flibanserin for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in naturally
      postmenopausal women.
    

Eligibility criteria:

        Inclusion criteria:

          -  Naturally postmenopausal women of any age with at least one ovary

          -  Diagnosis of Hypoactive Sexual Desire Disorder, generalized acquired type,of at least
             six months duration

          -  Stable, monogamous heterosexual relationship for at least one year

          -  Willing to discuss sexual issues

          -  Willing to engage in sexual activity at least once a month

          -  Normal Pap smear

          -  Normal mammogram

          -  Normal uterine lining

          -  Able to comply with daily use of handheld data entry device

        Exclusion criteria:

          -  Sexual dysfunctions other than HSDD, such as Sexual Aversion Disorder,
             Substance-induced Sexual Dysfunction, Dyspareunia, Vaginismus, Gender Identity
             Disorder, Paraphilia and Sexual Dysfunction due to a General Medical Condition

          -  Partner with inadequately treated organic or psychosexual dysfunction

          -  Sexual function impaired by psychiatric disorder

          -  Sexual function impaired by gynecological disorder

          -  Major Depression

          -  Suicidal behavior or ideation

          -  Major life stress that could impair sexual function

          -  Substance abuse
LUX-Head&Neck 1: A Phase III Trial of Afatinib (BIBW2992) Versus Methotrexate for the Treatment of Recurrent and/or Metastatic (R/M) Head and Neck Squamous Cell Cancer After Platinum Based Chemotherapy
Condition: Head and Neck Neoplasms; Carcinoma, Squamous Cell
MeSH terms: Carcinoma; Head and Neck Neoplasms; Carcinoma, Squamous Cell
Intervention: Afatinib; Methotrexate
Intervention description: Once daily; Weekly
Intervention MeSH terms: Methotrexate; Afatinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 483.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomised, open-label, phase III study will be performed in patients with R/M head and
      neck squamous cell carcinoma (HNSCC) who have progressed after platinum-based therapy. The
      objectives of the trial are to compare the efficacy and safety of afatinib versus
      methotrexate
    

Eligibility criteria:

        Inclusion criteria:

          1. Histologically or cytologically confirmed R/M HNSCC of the oral cavity, oropharynx,
             hypopharynx or larynx, not amenable for salvage surgery or radiotherapy

          2. Documented progressive disease based on investigator assessment according to Response
             Evaluation Criteria in Solid Tumours (RECIST) following receipt of at least two cycles
             of cisplatin or carboplatin administered for R/M disease

          3. Measurable disease according to RECIST

          4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

        Exclusion criteria:

          1. Progressive disease within three months of completion of curatively intended treatment
             for locoregionally advanced or metastatic HNSCC

          2. Any other than one previous platinum based systemic regimen given for R/M disease

          3. Prior treatment with epidermal growth factor receptor (EGFR)-targeted small molecules

          4. Pregnancy or breast feeding
Efficacy and Safety Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes
Condition: Idiopathic Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: CVT-301 Low Dose; CVT-301 High Dose; Placebo
Intervention MeSH terms: Levodopa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 351.0
Sex: All
Minimum age: 30 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Parkinson's Disease; Motor fluctuations; levodopa; inhaled drugs; OFF episodes

Summary:

      This randomized, multicenter, placebo-controlled, double-blind study will evaluate the
      efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing
      motor response fluctuations (OFF phenomena) as an outpatient (i.e., at home) and in the
      clinic.

      Patients who successfully complete this study will be eligible to enroll into a 12 month
      treatment extension (CVT-301-004E) study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Idiopathic Parkinson's Disease (PD) diagnosed between the ages of 30 and 85 years;

          -  Hoehn and Yahr Stage 1-3 in an "on" state;

          -  Require levodopa-containing medication regimen at least 3 times during the waking day;

          -  Experience motor fluctuations with a minimum of 2 hours of average daily "off" time
             per waking day (excluding early morning "off" time) and demonstrate levodopa
             responsiveness;

          -  Are on stable PD medication regimen;

          -  Total daily LD dose <1600 mg/day;

          -  Able to perform a spirometry maneuver in the ON and OFF states;

          -  Normal cognition confirmed by MMSE score ≥25

        Exclusion Criteria:

          -  Pregnant or lactating females;

          -  Previous surgery for PD or plan to have stereotactic surgery during the study period;

          -  History of psychotic symptoms requiring treatment, or suicide ideation or attempt
             within last year;

          -  Known contraindication to the use of levodopa;

          -  Any significant condition, severe concurrent disease, abnormality or finding that
             would make patients unsuitable or may compromise patient safety;

          -  Any contraindication to performing routine spirometry.
Preoperative Acetaminophen and Carbohydrate Loading
Condition: Non-melanoma Skin Cancer
MeSH terms: Skin Neoplasms
Intervention: Acetaminophen
Intervention description: Acetaminophen 1000mg
Intervention MeSH terms: Acetaminophen
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Mohs micrographic surgery; pain; functional status

Summary:

      The study's goal is to assess impact of preoperative acetaminophen and oral carbohydrate
      drinks on pain and functional status experienced by patients undergoing Mohs micrographic
      surgery for non-melanoma skin cancers. Patients are randomly assigned to receive standard of
      care or preoperative acetaminophen 1000 mg and Gatorade sports drinks 2 packets before
      surgery. Patients are then asked to rate their level of pain, anxiety, thirst, hunger,
      fatigue on a scale of 0-100 on day of surgery before surgery has started, after clearance of
      skin cancer, and at the end of the visit. Patients are contacted by phone 48 hours after
      their surgery to assess their maximum level of post-operative pain (rated from 0-100), usage
      of over the counter or prescribed pain medications, and presence of complications e.g.
      bleeding, infection, dehiscence. Differences in perioperative functional status and pain
      medication usage are compared between patients in control and intervention groups.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients undergoing Mohs micrographic surgery for non-melanoma skin cancers
             (basal cell carcinoma and squamous cell carcinoma)

        Exclusion Criteria:

          -  history of liver transplant, hepatitis, or cirrhosis, those required to be NPO for
             subsequent closure by other surgical specialties, or those with known allergy to
             acetaminophen
Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Abdominoplasty
Condition: Acute Pain
MeSH terms: Acute Pain
Intervention: Oliceridine; Placebo; Morphine
Intervention MeSH terms: Morphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 407.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective is to evaluate the analgesic efficacy of intravenous (IV) oliceridine
      administered as needed (PRN) compared with placebo in patients with moderate to severe acute
      pain after abdominoplasty.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has undergone abdominoplasty with no additional collateral procedures.

          -  Experiences a pain intensity rating of moderate to severe acute pain.

          -  Able to provide written informed consent before any study procedure.

        Exclusion Criteria:

          -  ASA Physical Status Classification System classification of P3 or worse.

          -  Has surgical or post-surgical complications.

          -  Has clinically significant medical conditions or history of such conditions that may
             interfere with the interpretation of efficacy, safety, or tolerability data obtained
             in the trial, or may interfere with the absorption, distribution, metabolism, or
             excretion of drugs.

          -  Has previously participated in another TRV130 clinical study.