bioihbjkbjnl/mcl2 huggingface dataset:
Nasal Packing as a Drug Delivery System Postoperatively in Chronic Sinusitis With Polyposis
Condition: Chronic Sinusitis; Polyposis
MeSH terms: Sinusitis; Colorectal Neoplasms; Nasopharyngeal Neoplasms; Chronic Disease
Intervention: pulmicort
Intervention description: applied to nasal packing after surgery
Intervention MeSH terms: Budesonide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      That high-dose steroid applied to the nasal cavity immediately post-operatively will improve
      olfaction and healing following endoscopic sinus surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  hyposmia and nasal obstruction for >12 weeks

          -  bilateral nasal polyposis

          -  candidate for surgery

        Exclusion Criteria:

          -  immunocompromised

          -  non-English speaking

          -  prisoner

          -  pregnant/lactating

          -  will not attend follow up appointments
Double-blind, Randomized Study Evaluating the Efficacy and Safety of Brivaracetam in Adults With Partial Onset Seizures
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Intervention: Placebo; Brivaracetam; Brivaracetam; Brivaracetam
Intervention description: Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 12-week Treatment Period; Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 20 mg /day in a double-blinded way for the 12-week Treatment Period; Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 50 mg /day in a double-blinded way for the 12-week Treatment Period.; Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 100 mg /day in a double-blinded way for the 12-week Treatment Period.
Intervention MeSH terms: Brivaracetam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 399.0
Sex: All
Minimum age: 16 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Epilepsy; Brivaracetam; Partial Onset Seizures

Summary:

      This study will evaluate the efficacy and safety of Brivaracetam to support the submission
      file in the indication of adjunctive treatment in adolescents and adults with partial onset
      seizures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects were from 16 to 70 years, both inclusive. Subjects under 18 years of age were
             only included where legally permitted and ethically accepted

          -  Subjects with well-characterized focal epilepsy or epileptic syndrome according to the
             International League Against Epilepsy (ILAE) classification

          -  Subjects had a history of partial onset seizures (POS) whether or not secondarily
             generalized (Type I seizures according to the ILAE classification)

          -  Subjects had at least 2 POS whether or not secondarily generalized per month during
             the 3 months preceding Visit 1

          -  Subjects had at least 8 POS whether or not secondarily generalized during the 8-Week
             Baseline Period

          -  Subjects were uncontrolled while treated by 1 to 2 permitted concomitant antiepileptic
             drugs (AEDs). Vagal nerve stimulation was allowed and was not counted as a concomitant
             AED

        Exclusion Criteria:

          -  History or presence of seizures occurring only in clusters (too frequently or
             indistinctly separated to be reliably counted) before Visit 3

          -  History or presence of status epilepticus during the year preceding Visit 1 or during
             Baseline
Effects of Pioglitazone on High-density Lipoprotein (HDL) Function in Persons With Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: pioglitazone
Intervention description: 30 mg daily for three weeks increase to 45 mg daily for 21 more weeks
Intervention MeSH terms: Pioglitazone
Phase: Phase 3
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 35 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: diabetes; dyslipidemia; pioglitazone; HDL-Cholesterol; Reverse cholesterol transport

Summary:

      Metabolic defects contributing to the development of type 2 diabetes (T2D) are relative
      insulin insufficiency and insulin resistance that are associated with a cluster of
      abnormalities that increase the risk for cardiovascular disease including dyslipidemia,
      inflammation, hemodynamic changes and endothelial dysfunction. The dyslipidemia associated
      with T2D is characterized by elevated triglycerides and decreased high-density
      lipoprotein-cholesterol (HDL). The ability of the insulin sensitizing agent pioglitazone
      (ACTOS®) , to improve hyperglycemia in subjects with T2D is now well established.
      Pioglitazone functions as a PPAR-γ (peroxisome proliferator-activated receptor gamma)
      agonists and this class of drugs have demonstrated several other potential benefits, beyond
      glucose homeostasis. Specifically pioglitazone can improve diabetic dyslipidemia by
      increasing HDL cholesterol and lowing triglycerides. A potential beneficial effect on reverse
      cholesterol transport may be mediated by the increased HDL levels. This proposal aims to
      examine the effect of PPAR-γ activation by PIO on various aspects of reverse cholesterol
      transport by testing the hypothesis that PIO treatment affects key steps in the reverse
      cholesterol transport pathway either directly, through induction of protein expression, or
      indirectly, by altering HDL structure and composition leading to increase cholesterol flux
      through this pathway.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes, men and women, WHO criteria, aged 35-70 years

          -  HbA1c 7.5-10.0%

          -  BMI 26-39 Kg/m2

          -  Either receiving dietary therapy only or monotherapy with either sulfonylurea or
             metformin

          -  Already on statin therapy

        Exclusion Criteria:

          -  Cardiovascular disease

          -  Renal disease

          -  Other systemic disease

          -  Abnormal liver function tests (ALT or AST>1.5 X ULN)

          -  Uncontrolled hypertension (BP >160/110)

          -  Triglyceride levels >400 mg/dl

          -  Lipid modifying drugs; fibrates, ezetimibe, niacin, bile sequestrants, but not statins
             (see below),

          -  Estrogen treatment or thyroid disease

          -  Psychiatric condition or substance abuse
A Study of the Safety and Effectiveness of Ustekinumab (Stelara) in Chinese Patients With Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: placebo; ustekinumab; placebo; ustekinumab
Intervention description: Subcutaneous injection at Week 0 and 4; 45 mg subcutaneous injection at Week 12 and 16; Subcutaneous injection at Week 12; 45 mg subcutaneous injection at Week 0, 4 and 16
Intervention MeSH terms: Ustekinumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 322.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: psoriasis; asian patients; Chinese; ustekinumab; CNTO 1275; Stelara

Summary:

      The purpose of this study is to evaluate the efficacy (good or bad effects) and safety of
      ustekinumab in the treatment of patients with moderate to severe psoriasis in China.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be of Chinese ancestry

          -  Have had a diagnosis of plaque-type psoriasis at least 6 months prior to study start

          -  Have plaque-type psoriasis covering at least 10% of total BSA at screening and at the
             time of study start

          -  Have a Psoriasis Area and Severity Index (PASI) score of 12 or greater at study start

          -  Must be candidates for phototherapy or systemic treatment of psoriasis (either naive
             or history of previous treatment)

        Exclusion Criteria:

          -  Currently have nonplaque forms of psoriasis

          -  Have current drug-induced psoriasis

          -  Have used any investigational drug within the previous 4 weeks

          -  Have used any biologic within the previous 3 months

          -  Be known to be infected with human immunodeficiency virus (HIV), hepatitis B virus
             (HBV), hepatitis C virus (HCV), or syphilis
Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in Human Immunodeficiency Virus (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
Condition: HIV-1 Infection
Intervention: DTG; F/TAF; B/F/TAF; DTG Placebo; F/TAF Placebo; B/F/TAF Placebo
Intervention description: 50 mg tablets administered orally, once daily; 200/25 mg tablets administered orally, once daily; 50/200/25 milligrams (mg) FDC tablets administered orally, once daily; Tablets administered orally, once daily; Tablets administered orally, once daily; Tablets administered orally, once daily
Intervention MeSH terms: Dolutegravir; Emtricitabine tenofovir alafenamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 657.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV

Summary:

      This primary objective of this study is to evaluate the efficacy of a fixed dose combination
      (FDC) containing bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus
      dolutegravir (DTG) + a FDC containing emtricitabine/tenofovir alafenamide (F/TAF) in HIV-1
      infected, antiretroviral treatment-naive adults.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Antiretroviral treatment naive (≤ 10 days of prior therapy with any antiretroviral
             agent following a diagnosis of HIV-1 infection) except the use for pre-exposure
             prophylaxis (PrEP) or post-exposure prophylaxis (PEP), up to one month prior to
             screening

          -  Plasma HIV-1 ribonucleic acid (RNA) levels ≥ 500 copies per milliliter (mL) at
             screening

          -  Adequate renal function: Estimated glomerular filtration rate ≥ 30 mL per minute (min)
             (≥ 0.50 mL per second (sec)) according to the Cockcroft-Gault formula

        Key Exclusion Criteria:

          -  An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior
             to screening

          -  Decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding)

          -  Current alcohol or substance use judged by the Investigator to potentially interfere
             with subject study compliance

          -  Females who are pregnant (as confirmed by positive serum pregnancy test)

          -  Females who are breastfeeding

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Safety and Efficacy of Ranibizumab in Diabetic Macular Edema
Condition: Visual Impairment Due to Diabetic Macular Edema
MeSH terms: Vision Disorders; Vision, Low; Macular Edema; Edema
Intervention: Active laser photocoagulation; Sham injections; Ranibizumab 0.5 mg
Intervention description: Active laser photocoagulation procedure at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.; Sham intravitreal injections at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.; Ranibizumab 0.5 mg/0.05 ml intravitreal injection at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.
Intervention MeSH terms: Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 128.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetic macular edema; DME; Proliferative diabetic retinopathy; PDR; ranibizumab; laser

Summary:

      This study was designed to confirm the efficacy and safety of laser photocoagulation as
      adjunctive therapy to ranibizumab 0.5 mg versus laser monotherapy in patients with visual
      impairment due to Diabetic Macular Edema. A subgroup of patients with Proliferative Diabetic
      Retinopathy were included to evaluate the efficacy and safety of laser photocoagulation as
      adjunctive therapy to ranibizumab 0.5 mg versus laser monotherapy in this population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Visual acuity impairment caused by macular edema in at least one eye

          -  Type 1 or type 2 diabetes mellitus

          -  Stable medication of diabetes in past 3 month

        Exclusion Criteria:

          -  Patients with uncontrolled systemic or ocular diseases

          -  Laser photocoagulation in the study eye for the last 3 months

          -  Any history of any intraocular surgery in the study eye within the past 3 months

          -  Blood pressure > 160/100 mmHg

        Other protocol defined inclusion/exclusion criteria may apply
DFD01 Spray HPA Axis Suppression Study in Adolescent Patients With Moderate to Severe Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: DFD01 Spray
Intervention description: DFD-01 (betamethasone dipropionate) Spray, 0.05%
Intervention MeSH terms: Betamethasone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 12 Years
Maximum age: 16 Years
Healthy volunteers: No

Summary:

      To evaluate the potential of DFD-01 (betamethasone dipropionate) Spray, 0.05% to suppress the
      hypothalamic-pituitary-adrenal (HPA) axis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects must weigh at least 55 pounds

          2. Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque
             psoriasis.

          3. Subjects with psoriasis involving ≥ 10% BSA, not including the face, scalp, groin,
             axillae and other intertriginous areas..

          4. Subjects must have moderate to severe plaque psoriasis at the Baseline Visit.

          5. Subjects whose results from the screening ACTH stimulation test are considered normal
             (cortisol level >18 ug/dL at 30 minutes post stimulation) and show no other signs of
             abnormal HPA axis function or adrenal response.

        Exclusion Criteria:

          1. Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic,
             exfoliative or pustular psoriasis.

          2. History of organ transplant requiring immunosuppression, HIV, or other
             immunocompromised state.

          3. Have received treatment for any type of cancer within 5 years of the Baseline Visit.

          4. Use within 60 days prior to the Baseline Visit of: 1) immunosuppressive drugs (e.g.,
             tacrolimus, pimecrolimus), 2) systemic antipsoriatic treatment (e.g., methotrexate,
             cyclosporine, hydroxyurea), or 3) biologic treatment for psoriasis (e.g., infliximab,
             adalimumab, etanercept, ustekinumab, secukinumab, or alefacept).

          5. Use within 30 days prior to the Baseline Visit of: 1) topical antipsoriatic drugs
             (salicylic acid, anthralin, coal tar, calcipotriene), 2) PUVA therapy, 3) systemic
             anti-inflammatory agents (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine),
             or 4) UVB therapy.

          6. Use within 30 days prior to the Screening Visit of any product containing
             corticosteroids. Inhaled, intraocular, intranasal, etc. steroids are not allowed.

          7. Subjects who have an abnormal sleep schedule or work overnight.

          8. Subjects with a known history of acute adrenal crisis, Addison's disease or decreased
             adrenal output, low pituitary function or pituitary tumors.

          9. Subjects who have a history of an adverse reaction to cosyntropin injection or similar
             test reagents.
Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Adalimumab (GP2017) and Humira
Condition: Plaque Type Psoriasis
MeSH terms: Psoriasis
Intervention: GP2017 Adalimumab; Humira ® Adalimumab
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 465.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: plaque type psoriasis; equivalent efficacy; safety and immunogenicity; GP2017; Humira®

Summary:

      The aim of the study is to demonstrate equivalent efficacy and similarity in the safety
      profile of GP2017 and Humira® in patients with moderate to severe chronic plaque-type
      psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women at least 18 years of age at time of screening

          -  Chronic plaque-type psoriasis diagnosed for at least 6 months before randomization

          -  Moderate to severe psoriasis as defined at baseline by:

               -  PASI score of 12 or greater

               -  Investigator´s Global Assessment score of 3 or greater (based on a scale of 0 -
                  4) and,

               -  Body Surface Area affected by plaque-type psoriasis of 10% or greater

          -  Chronic plaque-type psoriasis patients who have previously received phototherapy or
             systemic psoriasis therapy at least once or who are candidates for such therapies in
             the opinion of the investigator.

        Exclusion Criteria:

          -  Forms of psoriasis other than chronic plaque-type

          -  Drug-induced psoriasis

          -  Ongoing use of prohibited psoriasis treatments

          -  Previous exposure to adalimumab

          -  Active ongoing inflammatory diseases other than psoriasis that might confound the
             evaluation of the benefit of treatment with adalimumab

        Other In-/Exclusion criteria may apply
Assessment of Efficacy and Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation
Condition: Opioid-Induced Constipation (OIC)
MeSH terms: Constipation; Opioid-Induced Constipation
Intervention: NKTR-118; NKTR-118; Placebo
Intervention description: 12.5 mg oral tablet once daily; 25 mg oral tablet once daily; Placebo to NKTR-118
Intervention MeSH terms: Naloxegol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 700.0
Sex: All
Minimum age: 18 Years
Maximum age: 84 Years
Healthy volunteers: No
Keywords: Non-Cancer-Related Pain; Opioid-Induced Constipation

Summary:

      The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of
      opioid-induced constipation in patients with non-cancer-related pain, including those
      patients that have inadequate response to laxative therapy (LIR).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of written informed consent prior to any study-specific procedures.

          -  Self-reported active symptoms of OIC at screening (<3 SBMs/week and experiencing ≥1
             reported symptom of hard/lumpy stools, straining, or sensation of incomplete
             evacuation/anorectal obstruction in at least 25% of BMs over the previous 4 weeks);
             and Documented confirmed OIC (<3 SBMs/week on average over the 2-week OIC confirmation
             period.

          -  Receiving a stable maintenance opioid regimen consisting of a total daily dose of 30
             mg to 1000 mg of oral morphine, or equianalgesic amount(s) of 1 or more other opioid
             therapies for a minimum of 4 weeks prior to screening for non-cancer-related pain with
             no anticipated change in opioid dose requirement over the proposed study period as a
             result of disease progression.

          -  Willingness to stop all laxatives and other bowel regimens including prune juice and
             herbal products throughout the 2-week OIC confirmation period and the 12-week
             treatment period, and to use only bisacodyl as rescue medication if a BM has not
             occurred within at least 72 hours of the last recorded BM.

        Exclusion Criteria:

          -  Patients receiving Opioid regimen for treatment of pain related to cancer.

          -  History of cancer within 5 years from first study visit with the exception of basal
             cell cancer and squamous cell skin cancer.

          -  Medical conditions and treatments associated with diarrhea, intermittent loose stools,
             or constipation.

          -  Other issues to the gastrointestinal tract that could impose a risk to the patient.

          -  Pregnancy or lactation.
A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder.
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: TC-5214; Placebo
Intervention description: Twice daily for 8 weeks.; Twice daily for 8 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 696.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder, MDD, Depression

Summary:

      The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like a
      medicine tablet or capsule, but contains no active medicine) is safe and effective when taken
      together with another antidepressant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of signed and dated informed consent before initiation of any study-related
             procedures.

          -  The patient must have a clinical diagnosis of major depressive disorder (MDD) with
             inadequate response to no more than one antidepressant.

          -  Outpatient status at enrollment and randomization.

        Exclusion Criteria:

          -  Patients with a lifetime history of bipolar disorder, psychotic disorder or
             post-traumatic stress disorder.

          -  Patients with a history of suicide attempts in the past year and/or seen by the
             investigator as having a significant history of risk of suicide or homicide.

          -  History of renal insufficiency or impairment or conditions that could affect
             absorption or metabolism of investigational product.