bioihbjkbjnl/mcl2 huggingface dataset:
Maintaining Nonsmoking
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Intervention: Varenicline; Initial Individual counseling; Check-ins with medical staff; Extended Individual Counseling - Health Model; Extended Individual Counseling - Relapse Prevention Model
Intervention description: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid. Participants in the Extended Relapse Prevention plus varenicline will receive varenicline for up to 40 additional weeks.; Five 90 minute individual counseling sessions to occur during the first 12 weeks of initial treatment.; Monthly brief (10-15 minutes) meetings with medical staff.; Monthly counseling sessions across a nine month period with content based on a health education model. Each session is 30-45 minutes in duration.; Eleven individual counseling sessions across a nine month period with content based on a relapse prevention model. Each session is 30-45 minutes in duration.
Intervention MeSH terms: Varenicline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 216.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Smoking; Tobacco; Nicotine; Smoking cessation

Summary:

      The research is based on a chronic disorder model of cigarette smoking which suggests that
      long-term treatment targeted to prevent relapse may be useful. Based on this model, the
      investigators have developed a relapse prevention treatment to intervene on five areas
      important in relapse prevention, including fluctuating motivation, depression, withdrawal,
      weight gain, and social support. This treatment protocol has produced high long-term
      abstinence rates when implemented in a clinical research setting. The current study will
      evaluate the treatment model when implemented in a medical outpatient setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years of age

          -  Must be smoking 5 or more cigarettes per day

        Exclusion Criteria:

          -  Previous history of bipolar/manic-depressive disorder

          -  Current diagnosis of schizophrenia

          -  Acute life threatening diseases

          -  Evidence of alcohol or other drug abuse so severe that the patient is judged to be
             potentially unable to comply with the protocol

          -  Pregnancy or lactation

          -  Individuals with out of normal range blood pressure, active angina, valve disease,
             valve replacement, active cardiomyopathies, myocardial infarction or Coronary artery
             bypass grafting (CABG) within one year, and Congestive heart failure (CHF)
Clinical Study Comparing Two Models of a Travoprost Intraocular Implant
Condition: Glaucoma, Open-Angle; Ocular Hypertension
MeSH terms: Ocular Hypertension; Glaucoma, Open-Angle
Intervention: G2-TR intraocular implant containing travoprost; Sham surgery + active-comparator eye drops
Intervention description: Provided in Arm/Group descriptions; Sham surgery plus postoperative active-comparator eye drops (Timolol Maleate ophthalmic solution, 0.5%)
Intervention MeSH terms: Travoprost; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 560.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Phase III study to compare the safety and efficacy of intraocular implants containing
      Travoprost at two different elution rates versus Timolol Maleate Ophthalmic Solution, 0.5%
      (Timolol) in reducing elevated intraocular pressure in subjects with open angle glaucoma
      (OAG) or ocular hypertension (OHT)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with open-angle glaucoma or ocular hypertension

          -  C/D ratio ≤ 0.8

          -  Zero to two preoperative ocular hypotensive medications

        Exclusion Criteria:

          -  Active corneal inflammation or edema

          -  Retinal disorders not associated with glaucoma
Multimodal Pain Management After Robotic-Assisted Total Laparoscopic Hysterectomy
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Gabapentin; Acetaminophen; Celecoxib; Ketorolac; Paracervical block with ropivacaine; Local anesthetic injection with ropivacaine at abdominal laparoscopic port sites; Hydromorphone; Oxycodone
Intervention description: 600mg PO PO x 1 prior to surgery (in pre-op) 300mg PO BID for 7 days post op; Acetaminophen 1000mg PO x1 prior to surgery (in pre-op) Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN post op; Celecoxib 200mg PO q 12h x 7d post op; 30mg IV once at end of hysterectomy procedure; 0.5% ropivacaine; 10 mL bilaterally (2 point) for total of 20mL; 0.5% ropivacaine; at all laparoscopic port sites; another 10mL ropivacaine in total; 1mg IV PRN q3h, post op, while inpatient; To be discharged home with: 12 tabs of 5mg PRN q4h
Intervention MeSH terms: Acetaminophen; Celecoxib; Ketorolac; Oxycodone; Gabapentin; Hydromorphone; Ropivacaine; Anesthetics, Local; Anesthetics
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Prospective cohort with retrospective controls
Masking: None (Open Label)
Enrollment: 68.0
Sex: Female
Minimum age: 25 Years
Maximum age: 90 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hysterectomy

Summary:

      Hysterectomy is the most common major gynecologic surgery performed in the US and is
      performed for a variety of indications including malignancy, pelvic mass, endometriosis,
      leiomyoma, and pelvic organ prolapse. The traditional regimen for pain control
      post-operatively is opioid-based however in light of the opioid epidemic, a transition to
      non-opioid pain medication regimens is desired by both physicians and patients alike. The
      goal of this study is to develop a multimodal non-opioid pain medication regimen that
      minimizes postoperative opioid use after robotic assisted total laparoscopic hysterectomy.
      Historical controls from January, 2017 to January, 2020 will be compared to our treatment arm
      from November, 2020 to November, 2022. Included in our treatment protocol is paracervical
      block and local ropivacaine at abdominal incision sites at surgical start, gabapentin and
      acetaminophen preoperatively and postoperatively, and celecoxib postoperatively. Opioid use
      will be measured 0-3 h postop and 3-24h postop (as surrogate marker of time spent recovering
      in the Post Anesthesia Care Unit (PACU), and during the full length of hospital stay); pain
      scores will additionally be measured.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women undergoing robotic-assisted total laparoscopic hysterectomy, with or without
             bilateral salpingo-oophorectomy

          -  Uterine weight ≤325 grams

        Exclusion Criteria:

          -  contraindication to any study medications (h/o gastric bypass, gastric ulcers, CKD)

          -  current opioid prescription
Liraglutide In Overweight Patients With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Overweight
Intervention: liraglutide; placebo
Intervention MeSH terms: Liraglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to examine the effects of liraglutide (a drug used to treat type
      2 diabetes) on glucose (sugar) control over the 26 week study period when used in addition to
      insulin.
    

Eligibility criteria:

        Inclusion Criteria:

        1) Type 1 Diabetes on continuous subcutaneous insulin infusion (CSII; also known as insulin
        pump) or multiple (four or more) injections of insulin per day. 2) Using a continuous
        glucose monitoring device (CGM) or regularly measuring their blood sugars four times daily.
        3) HbA1c of less than 8.5%. 4) Well versed with carbohydrate counting. 5) Age 18-75 years
        6) BMI≥ 25kg/m2 7) Age at diagnosis of type 1 diabetes should be <30 years. 8) evidence of
        auto-immunity to beta cells (GAD-65 and islet cell antibody screen)

        Exclusion Criteria:

        1)Type 1 diabetes for less than 6 months; 2)Coronary event or procedure (myocardial
        infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in
        the previous four weeks; 3)Hepatic disease (transaminase > 3 times normal) or cirrhosis;
        4)Renal impairment (serum eGFR <30ml/min/1.73m2); 5)HIV or Hepatitis B or C positive
        status; 6)Participation in any other concurrent clinical trial; 7)Any other
        life-threatening, non-cardiac disease; 8)Use of an investigational agent or therapeutic
        regimen within 30 days of study. 9) history of pancreatitis 10) pregnancy 11) inability to
        give informed consent 12) history of gastroparesis 13)history of medullary thyroid
        carcinoma or MEN 2 syndrome. 14) Smokers will be advised not to change their amount of
        smoking for the duration of the study; 15) Use of any agent other than insulin for
        treatment of diabetes (metformin, pramlintide or thiazolidinediones.
Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Primary Hyperlipidemia or Mixed Dyslipidemia At Risk Of Cardiovascular Events
Condition: Hyperlipidemia
MeSH terms: Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias
Intervention: Bococizumab (PF-04950615; RN316); Placebo
Intervention description: 150 mg every 2 weeks, subcutaneous injection for 52 weeks.; Subcutaneous injection every 2 weeks for 52 weeks.
Intervention MeSH terms: Bococizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 746.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Primary hyperlipidemia or mixed dyslipidemia; high risk of cardiovascular events; multiple cardiovascular disease risk factors.

Summary:

      This study is a multicenter, double-blind, randomized study to access the efficacy, safety
      and tolerability of Bococizumab (PF-04950615; RN316) in subjects with hyperlipidemia
      receiving background statin therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Treated with a statin

          -  Fasting LDL-C >=100 mg/dL and triglyceride <= 400 mg/dL

          -  High or very high risk of incurring a cardiovascular event

        Exclusion Criteria:

          -  Pregnant or breastfeeding females

          -  Cardiovascular or cerebrovascular event or procedure within 90 days

          -  Congestive heart failure NYHA class IV

          -  Poorly controlled hypertension
Open-Label Study of Uridine Triacetate in Pediatric Patients With Hereditary Orotic Aciduria
Condition: Hereditary Orotic Aciduria
MeSH terms: Purine-Pyrimidine Metabolism, Inborn Errors
Intervention: uridine triacetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 6 Months
Maximum age: 19 Years
Healthy volunteers: No

Summary:

      This protocol has two parts - the Main Study which is 42 days in length and the Treatment
      Extension which allows the patients who complete the Main Study to continue receiving
      treatment with uridine triacetate. The purpose of this study is to replace oral
      administration of uridine with oral administration of uridine triacetate in patients with
      hereditary orotic aciduria who have received (or would reasonably be expected to receive)
      clinical benefit from treatment with exogenous uridine. It is also to document the continued
      clinical benefit of exogenous uridine when patients are switched from oral administration of
      uridine to oral administration of uridine triacetate.
    

Eligibility criteria:

        Inclusion Criteria (Main Study):

          -  Patients with diagnosed hereditary orotic aciduria

          -  Judged by the investigator to have the initiative and means to be compliant with the
             protocol

          -  Able to take oral medications

          -  Able to provide written informed consent (patient or legally authorized
             representative)

          -  Females of childbearing potential must have a negative pregnancy test at screening

          -  Females of childbearing potential or males with partners of childbearing potential are
             to use one of the following acceptable birth control methods:

          -  Surgically sterile or partner is surgically sterile

          -  Using adequate contraception (hormonal contraceptives, double barrier methods, or
             intra-uterine devices)

          -  Patients who claim to be sexually inactive agree to use an acceptable method of
             contraception should she or he become sexually active from 14 days prior to first
             dosing, throughout the study and for 14 days after the last dose administration

        Exclusion Criteria (Main Study):

          -  Has a known allergy to uridine triacetate or any of its excipients

          -  Known to have ornithine transcarbamoylase deficiency

          -  Unable to have the initiative and means to be compliant with the protocol

          -  Unable to be compliant with taking oral medications

          -  Unable to provide written informed consent (patient or legally authorized
             representative)

          -  Female who is pregnant or lactating

        Inclusion Criteria (Treatment Extension)

          -  Patient successfully completed the Main Study

        Exclusion Criteria (Treatment Extension)

          -  Patient did not successfully complete the Main Study
Extension Study up to 3 Years for Secukinumab in Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Secukinumab; Placebo
Intervention description: Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17).; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 460.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Extension study, psoriatic arthritis, pre-filled syringe

Summary:

      This study was designed as a 3-year extension to the phase III core study CAIN457F2306. It
      aimed to provide continuous treatment with secukinumab in pre-filled syringes (PFS) for
      subjects who completed the core study CAIN457F2306, to obtain further long term efficacy,
      safety and tolerability information in subjects with active psoriatic arthritis receiving
      secukinumab every 4 weeks. At Week 104 of the study CAIN457F2306, eligible subjects completed
      the assessments associated with the core study visit and subsequently continued in this
      extension study on the same dose that they were receiving during the core study. The regular
      assessments of disease activity ensure that subjects who are experienced worsening of disease
      in any of the treatment groups could exit the study upon their own wish or based on the
      advice of the investigator at any time.
    

Eligibility criteria:

        Inclusion criteria

          -  Subjects must be able to understand and communicate with the investigator and comply
             with the requirements of the study and must give a written, signed and dated informed
             consent before any study assessment is performed

          -  Subjects must have participated in core study CAIN457F2306, and must have completed
             the entire treatment period

          -  Subjects must be deemed by the investigator to benefit from continued secukinumab
             therapy

        Exclusion criteria

          -  Any subject taking other concomitant biologic immunomodulating agent(s) except
             secukinumab

          -  Any subject who is deemed not to be benefiting from the study treatment based upon
             lack of improvement or worsening of their symptoms

          -  Pregnant or nursing (lactating) women

          -  Women of child-bearing potential, unless they are using effective methods of
             contraception during the entire study or longer if required by locally approved
             prescribing information (e.g., 20 weeks in EU)

        Other protocol-defined inclusion/exclusion criteria may apply
FREEDOM - M: Oral Treprostinil as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Hypertension
Intervention: Oral treprostinil (UT-15C) Sustained Release Tablets; Placebo
Intervention description: Sustained release oral tablet, twice daily; Placebo oral tablet twice daily
Intervention MeSH terms: Treprostinil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 349.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Pulmonary Arterial Hypertension

Summary:

      This study was an international, multicenter, randomized (2:1 active:placebo), double-blind,
      placebo-controlled study in subjects with PAH who were NOT currently receiving approved
      therapy for their PAH. Study visits occurred at 4 week intervals for 12 weeks (with an
      additional visit at Week 11) with the key measure of efficacy being the 6-minute walk test.
      Study procedures included routine blood tests, medical history, physical exams, disease
      evaluation, and exercise tests. Two optional substudies were also a part of FREEDOM-M at
      select centers - a hemodynamic substudy with a right heart catheterization at Baseline and
      Week 12 and a genetics and biomarkers substudy with blood samples collected at Baseline and
      Week 12.

      Patients who completed all assessments for 12 weeks were also eligible to enter an
      open-label, extension phase study (FREEDOM - EXT).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Between 12 and 75 years of age, inclusive.

          -  Body weight at least 40 kg with a Body Mass Index < 45

          -  PAH that is either idiopathic/heritable; associated with repaired congenital
             systemic-to-pulmonary shunts (repaired ≥ 5 years); associated with collagen vascular
             disease; associated with HIV.

          -  Previous testing (e.g., right heart catheterization, echocardiography) consistent with
             the diagnosis of PAH.

          -  Baseline 6-minute walk distance between 200 and 425 meters, inclusive.

          -  Reliable and cooperative with protocol requirements.

        Exclusion Criteria:

          -  Nursing or pregnant.

          -  Currently receiving an endothelin receptor antagonist, a phosphodiesterase-5
             inhibitor, or prostacyclin within 30 days of Baseline.

          -  PAH due to conditions other than noted in the above inclusion criteria.

          -  History of uncontrolled sleep apnea, renal insufficiency, anemia, left sided heart
             disease, uncontrolled systemic hypertension, or parenchymal lung disease.

          -  Use of an investigational drug within 30 days of Baseline.
Efficacy and Safety of APP13007 for Treatment of Inflammation and Pain After Cataract Surgery Including a Corneal Endothelial Cell Sub-study
Condition: Ocular Inflammation and Pain After Cataract Surgery
MeSH terms: Cataract; Capsule Opacification; Inflammation
Intervention: APP13007, 0.05%; Matching Vehicle Placebo for APP13007, 0.05%
Intervention description: APP13007 eye drop, 0.05%; Matching vehicle placebo eye drop
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 370.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This Phase 3 study will evaluate APP13007 in comparison to the matching vehicle placebo in a
      randomized, parallel-group, double-masked fashion. The subjects will have undergone routine
      cataract surgery on Day 0 of the study and will be assessed the next day (Post-operative Day;
      POD1) after uncomplicated surgery for eligibility for randomization to study treatment. The
      study comprises the Main Study and the Endothelial Cell Sub-study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients 18 years of age or older expected to undergo unilateral uncomplicated
             cataract extraction via phacoemulsification and posterior chamber intraocular lens
             implantation in one eye.

          -  Have a pin-hole corrected visual acuity without other correction of ≤ 1.3 logarithm of
             the minimum angle of resolution (logMAR) in the study eye to be operated and
             contralateral eye as measured using an Early Treatment Diabetic Retinopathy Study
             (ETDRS) chart at Visit 1.

          -  Willing and able to comply with study requirements and visit schedule.

          -  Provide signed and dated informed consent.

        Exclusion Criteria:

          -  Have a known sensitivity or allergy to clobetasol propionate, corticosteroids, or any
             of the study medication's components including benzalkonium chloride and soybean
             lecithin or any routine medication required during cataract surgery or for the conduct
             of study procedures

          -  Have an ACC count > 0 or any evidence of intraocular inflammation (e.g., flare) in
             either eye at the Screening visit

          -  Have a Grade > 0 on the Ocular Pain Assessment in either eye at the Screening visit

        Note: Other inclusion/exclusion criteria apply.