bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Aclidinium Bromide 400 µg Compared to Placebo and to Tiotropium Bromide in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Aclidinium bromide; Tiotropium; Placebo
Intervention description: Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h); Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h); Dosage form: Dry powder Route of administration: Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h).
Intervention MeSH terms: Bromides; Tiotropium Bromide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 414.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; antimuscarinic

Summary:

      The aim of the present study is to evaluate the 24h bronchodilatory efficacy of inhaled
      aclidinium bromide 400 µg administered twice a day versus placebo and tiotropium bromide,
      respectively, after 6 weeks of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult male and female patients aged ≥40 with stable moderate to severe COPD (GOLD
             guidelines).

          -  Post-salbutamol (FEV1) < 80% and ≥ 30% of predicted normal value and Post-salbutamol
             FEV1/FVC < 70%.

          -  Current or ex-smokers of 10 ≥pack-years.

        Exclusion Criteria:

          -  Patients with no history or current diagnosis of asthma.

          -  No evidence of an exacerbation within 6 weeks prior to the screening visit.

          -  No evidence of clinically significant respiratory and/or cardiovascular conditions or
             laboratory abnormalities.

          -  No contraindication to use of anticholinergic drugs such as known symptomatic
             prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.
A Study of Long-term Administration of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Study P06333AM1)
Condition: Rhinitis, Allergic, Perennial
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: mometasone furoate
Intervention description: MFNS 50 μg spray device
3 to 11 years: one spray per nostril once daily (100 μg/day) in the morning.
12 to 15 years: 2 sprays per nostril once daily (200 μg/day) in the morning.
Intervention MeSH terms: Mometasone Furoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 3 Years
Maximum age: 15 Years
Healthy volunteers: No

Summary:

      Mometasone furoate nasal spray (MFNS) is a once-a-day product. This is a multi-center,
      open-label study of MFNS in children with perennial allergic rhinitis. MFNS will be
      administered to pediatric subjects (3-15 years old) with perennial allergic rhinitis at a
      dose of 100 to 200 μg/day (once daily) for 12 weeks. Subjects (subject's legal
      representatives) provided consent to continue treatment beyond 12 weeks will receive
      treatment for up to 24 weeks. At each clinic visit, observation of adverse events, nasal
      symptom scores, and nasal findings will be evaluated. The presence/absence of serious adverse
      events and trial procedure-related AEs will be reviewed 30 days after the end of the
      follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects having symptoms of perennial allergic rhinitis of moderate to severe degree.

          -  Subjects confirmed to be allergic to non-seasonal environmental antigens (e.g., house
             dust mite antigen).

          -  Male or female outpatients aged 3 to 15 years at the time of providing informed
             consent.

        Exclusion Criteria:

          -  Subjects with coexisting tuberculosis or lower respiratory tract infection, or who
             have an acute upper respiratory tract infection or acute pharyngolaryngitis, etc.
             judged by the investigator to require treatment at the time of registration

          -  Subjects with coexisting infections or systemic mycosis for which there are no
             effective antibiotics

          -  Subjects with repeated epistaxis

          -  Subjects with coexisting fungal infection in nasal/sinus cavity

          -  Subjects with a history of hypersensitivity to steroids or ingredients of mometasone
             furoate nasal spray

          -  Subjects with severe hepatic, renal, cardiac, hematological disease, diabetes
             mellitus, hypertension, or other serious coexisting diseases and whose general
             condition is poor.

          -  Subjects allergic to pollen (cedar, Japanese cypress, birch, grasses, mugwort, common
             ragweed, etc.) for whom the pollen season coincides with the observation period
1. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder
Condition: Hypoactive Sexual Desire Disorder
MeSH terms: Hypokinesia; Sexual Dysfunctions, Psychological
Intervention: Bremelanotide; Placebo
Intervention description: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone); Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 723.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HSDD; Female Sexual Desire Disorder

Summary:

      A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an
      optional Open-label Extension to evaluate the efficacy of bremelanotide (BMT), administered
      subcutaneously (SC) on an as needed basis for the treatment of HSDD (with or without
      decreased arousal) in premenopausal females.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Has met diagnostic criteria for HSDD for at least 6 months

          -  Is willing and able to understand and comply with all study requirements

          -  Has a normal pelvic examination at screening

        Main Exclusion Criteria:

          -  Subjects should be generally healthy premenopausal females with no psychological,
             gynecological or urological conditions which might contribute to the sexual
             dysfunction, compromise study participation, or confound interpretation of the study
             results

          -  Not currently under treatment for the sexual dysfunction and willing to forego other
             treatments through the course of the clinical trial
Fluocinolone Acetonide Implant Compared to Sham Injection in Patients With Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: fluocinolone acetonide; Fluocinolone Acetonide; Standard of care laser photocoagulation
Intervention description: 0.5 mg fluocinolone acetonide intravitreal insert; 0.2 mg fluocinolone acetonide intravitreal insert; Laser photocoagulation
Intervention MeSH terms: Fluocinolone Acetonide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 956.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of an intravitreal insert of fluocinolone
      acetonide for the treatment of diabetic macular edema.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age >= 18 years with diabetic macular edema

          -  Diagnosis of diabetes mellitus types 1 or 2

          -  Best corrected visual acuity of 19-68 letters

          -  Retinal thickness > 250 micron by OCT

          -  Investigator is comfortable deferring macular laser treatment for 6 weeks

        Exclusion Criteria:

          -  Glaucoma, ocular hypertension, IOP >21 mmHg or concurrent therapy at screening with
             IOP lowering agents

          -  Retinal or choroidal neovascularization due to ocular conditions other than diabetic
             retinopathy

          -  Prior intravitreal, subtenon, or periocular steroid therapy within 6 months

          -  Any ocular surgery within the last 3 months

          -  Retinal laser treatment within the last 3 months

          -  History of uncontrolled IOP elevation with steroid use that did not respond to topical
             therapy

          -  Any lens opacity which impairs visualization of the posterior pole
Safety Study of SPARC1104
Condition: Spasticity
MeSH terms: Muscle Spasticity
Intervention: SPARC1104 modified dose regimen I; SPARC1104 modified dose regimen II; SPARC1104 modified dose regimen III
Intervention description: Subjects who exited study CLR_09_21; Subjects who received prior treatment regimen I; Subjects who received no prior treatment regimen
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 375.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: spasticity

Summary:

      Open-label, safety study of SPARC1104 in subjects with spasticity due to multiple sclerosis
    

Eligibility criteria:

        -  Willingness to participate and give written informed consent

          -  Men and women ≥ 18 years of age

          -  Sexually active women who are of child bearing potential will practice an acceptable
             method of birth control for the duration of the trial as judged by the investigator.
             Examples of acceptable contraception are: condoms, foams, jellies, diaphragm,
             intrauterine device, oral or long-acting injected contraceptives, bilateral tubal
             ligation, bilateral oophorectomy, hysterectomy, or having a partner who is incapable
             of initiating conception. The practice of contraception must have started at least 3
             months prior to trial entry.

          -  If female, negative pregnancy test result at Screening

          -  Diagnosed with MS and a known history of spasticity

          -  Meet one of the following criteria o Subjects who completed the double-blind
             randomized withdrawal phase (Part 3) of trial CLR_09_21 with no major protocol
             violation
Prevention of Altitude Illness With Non-steroidal Anti-inflammatory Study (PAINS)
Condition: Altitude Sickness
MeSH terms: Altitude Sickness
Intervention: Ibuprofen; Placebo
Intervention description: 3 x 200mg (600mg total) x tid and one dosing on the subsequent day ( 4 doses total); identical number of visually identical tasteless pills as ibuprofen arm
Intervention MeSH terms: Ibuprofen
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 89.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a research study on Altitude Illness. From the information collected and studied in
      this project we hope to learn more about Altitude Illness, including factors that may affect
      and prevent the development and progression of this condition. We hope to learn if the
      commonly used non-steroidal anti-inflammatory medication, ibuprofen can prevent altitude
      illness. Possible participants in this study are healthy adults who indicated they would like
      to participate, learn about altitude illness, and desire to hike Barcroft Peak. Stanford
      University researchers hope to enroll about 100 participants.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy Male or female volunteer

          2. Age 18-65

          3. Sea-level dwelling

          4. Non pregnant

          5. Have not been to high altitude in the past week

          6. Can arrange for their own transportation to WMRS by friday evening the weekend of
             their study enrollment and are available the duration of the weekend of their study
             enrollment

        Exclusion Criteria:

          1. Age <18 or >65

          2. Live at altitude > Sea Level +/- 1000'

          3. Pregnant

          4. Taking NSAIDs, Acetazolamide, or Corticosteroids

          5. Allergic to NSAIDs or Aspirin, or have had adverse reaction to them in the past

          6. Traveled or planning to travel to high altitude in the week prior to their enrollment.

          7. Medical history of Brain Tumor, increased intercranial pressure, pseudotumor cerebri,
             ventricular shunts, loss of an eye, Asthma, HACE or HAPE.

          8. Cannot arrange for their own transportation to WMRS or are unavailable for the
             duration of the weekend of their study enrollment
Evaluating the Role of Pregabalin in Reducing Opioid Requirement in Spinal Fusion Surgeries of Two or More Vertebrae
Condition: Spinal Fusion
Intervention: Pregabalin; placebo
Intervention description: On the day of the surgery, 1hour + 15 minutes before the surgery starts, the subject will receive either 300mg of pregabalin or a similarly packaged placebo. On post operative day one, 150 mg of pregabalin or placebo will be given in two doses 12hrs apart.; placebo
Intervention MeSH terms: Pregabalin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Spinal fusion; pregabalin; Spinal fusion surgeries; two or more vertebrae

Summary:

      To see if the administration of 3 dosses of pregabalin (1 dose preoperative, 2 doses
      postoperative) will reduce the postoperative opiate requirements of patients undergoing
      spinal fusion surgeries of two or more vertebrae.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age : > 18 years old

          -  Fusion of > two vertebrae

          -  Capacity to provide consent

          -  ASA I-IV

          -  Ability to swallow capsules

        Exclusion Criteria:

          -  Plan of care includes intubated ICU admission post-op

          -  Allergy to gabapentin or pregabalin

          -  Two week prior use of pregabalin

          -  Significant renal dysfunction (creatinine level >2)

          -  Severe cardiovascular disease

          -  History of frequent headaches or dizziness

          -  Significant hepatic dysfunction (LFT's > 4 times the normal ranges)

          -  Active usage of alcohol or illicit substances three days prior to surgery

          -  History of seizure disorders

          -  Taking medication for anxiety, antiseizure, and psychiatric diagnoses

          -  Re-operation patients
LDL-C Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-2
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias
Intervention: Evolocumab; Ezetimibe; Placebo to Evolocumab; Placebo to Ezetimibe; Atorvastatin; Rosuvastatin; Simvastatin
Intervention description: Administered by subcutaneous injection; Administered orally once a day; Administered by subcutaneous injection; Administered orally once a day; Administered orally once a day; Administered orally once a day; Administered orally once a day
Intervention MeSH terms: Atorvastatin; Rosuvastatin Calcium; Simvastatin; Ezetimibe; Evolocumab; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2067.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: High cholesterol, Treatment for high cholesterol, Lowering cholesterol, Lowering high cholesterol, Hypercholesterolemia

Summary:

      The primary objective was to evaluate the effect of 12 weeks of evolocumab administered
      subcutaneously every 2 weeks (Q2W) and monthly (QM) when used in combination with a statin,
      compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol
      (LDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥ 18 to ≤ 80 years of age

          -  Subjects not taking a statin must have fasting LDL-C of at least 150 mg/dL (4.0
             mmol/L)

          -  Subjects already on a non-intensive statin must have fasting LDL-C at screening ≥ 100
             mg/dL (2.6 mmol/L)

          -  Subjects already on a intensive statin must have fasting LDL-C at screening ≥ 80 mg/dL
             (2.1 mmol/L)

          -  Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)

        Exclusion Criteria:

          -  Statin intolerance

          -  New York Heart association (NYHA) III or IV heart failure

          -  Uncontrolled hypertension

          -  Uncontrolled cardiac arrhythmia

          -  Type 1 diabetes, poorly controlled type 2 diabetes

          -  Uncontrolled hypothyroidism or hyperthyroidism
ALK21-006EXT: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol- or Opioid-dependent Adults (Extension of Study ALK21-006 [NCT01218997])
Condition: Alcoholism; Opiate Dependence
MeSH terms: Alcoholism; Opioid-Related Disorders
Intervention: Medisorb naltrexone 380 mg; Oral naltrexone to Medisorb naltrexone 380 mg
Intervention description: Administered via intramuscular (IM) injection once every 4 weeks. Subjects in this dosing group also received this treatment throughout the base study.; Subjects in this dosing group received oral naltrexone 50 mg in the base study, but received only Medisorb naltrexone 380 mg in this extension study, administered via IM injection once every 4 weeks.
Intervention MeSH terms: Naltrexone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 108.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This was a multicenter extension of Alkermes' Study ALK21-006 (NCT01218997) designed to
      assess the long-term safety of repeat monthly doses of naltrexone long-acting injection. All
      subjects received open-label Medisorb® naltrexone 380 mg (VIVITROL®).

      Planned treatment duration was up to 3 years. Alkermes terminated the study for business
      purposes in December 2006. The median duration of treatment among all subjects in this
      extension study was 43 weeks.
    

Eligibility criteria:

        Primary Inclusion Criteria:

          -  Adults with a diagnosis of alcohol and/or opioid dependence as defined by the
             Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) who had satisfactorily
             completed Alkermes' Study ALK21-006 or other qualifying Medisorb naltrexone study

          -  Willing and able to return for scheduled clinic visits and study assessments

          -  Had a stable address

          -  Agreed to use a contraception for the duration of the study and for 1 month following
             the last dose if of childbearing potential

          -  Written informed consent

        Primary Exclusion Criteria:

          -  Pregnancy or lactation

          -  Terminated early from study drug in a previous Medisorb naltrexone clinical trial

          -  Any finding that, in the view of the investigator, would compromise the ability to
             fulfill the protocol visit schedule and/or visit requirements
Safety and Efficacy of Cariprazine for Bipolar I Disorder
Condition: Mania; Bipolar I Disorder
MeSH terms: Mania
Intervention: Cariprazine; Placebo
Intervention description: Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for three weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.; Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for three weeks.
Intervention MeSH terms: Cariprazine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 497.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Acute Mania; Bipolar I Disorder

Summary:

      The objective of this study is to evaluate the efficacy, safety, and tolerability of
      cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes
      associated with bipolar I disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have provided informed consent prior to any study specific procedures

          -  Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders,
             Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder, as
             confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual
             of Mental Disorders, Fourth Edition (SCID) manic or mixed type with or without
             psychotic symptoms

          -  Voluntarily hospitalized for current manic episode

          -  Patients with normal physical examination, laboratory, vital signs,and/ or
             electrocardiogram (ECG)

        Exclusion Criteria:

          -  Patients with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I
             disorder that was the primary focus of treatment within the previous six months