bioihbjkbjnl/mcl2 huggingface dataset:
Study to Explore the Effect of Secukinumab, Compared to Placebo, on Fat Tissue and Skin in Plaque Psoriasis Patients
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Secukinumab; Placebo
Intervention description: Secukinumab 300 mg s.c. at randomization, Weeks 1, 2, 3, and 4 was followed by monthly dosing up to Week 48; Placebo s.c. at randomization, Weeks 1, 2, 3, 4, and 8; secukinumab 300 mg s.c. at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing up to Week 48
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: scalp psoriasis; plaque psoriasis; secukinumab; AIN457; biologic; monoclonal antibod; psoriasis; AIN457A

Summary:

      This study provided a comparison of secukinumab to placebo with respect to skin inflammation
      as measured by skin exams in comparison to skin biopsies, adipose tissue and blood sample
      analyses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent must be obtained before any assessment is performed

          -  Clinical diagnosis of chronic plaque-type psoriasis at least 6 months prior to
             randomization

          -  Moderate to severe plaque psoriasis as defined at baseline by:

               -  ≥10% Body Surface Area (BSA) involvement and

               -  PASI total score of ≥12 and

               -  IGA mod 2011 score of ≥3 (based on a scale of 0-4)

        Exclusion Criteria:

          -  Forms of diagnosed psoriasis other than chronic plaque psoriasis

          -  Medication-induced or medication exacerbated psoriasis

          -  Previous exposure to secukinumab or any other biologic drug directly targeting IL-17A
             or IL-17RA receptors

          -  Ongoing use of prohibited treatments

          -  Pregnant or nursing (lactating) women

        Other protocol-defined inclusion/exclusion criteria may apply
Effect of Velphoro on Serum Phosphate and Albumin in Peritoneal Dialysis Patients
Condition: Peritoneal Dialysis Complication; Hyperphosphatemia; Hypoalbuminemia
MeSH terms: Hypoalbuminemia; Hyperphosphatemia
Intervention: Sucroferric Oxyhydroxide Chewable Tablet
Intervention description: Patients will be started on 1 tablet three times daily with meals and the dose will be titrated monthly in increments of 500mg (1 tablet) per day until serum phosphate is at goal
Intervention MeSH terms: Ferric Compounds
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Prospective pilot study to determine if changing the phosphate binder to sucroferric
      oxyhydroxide for for 6 months improves disordered mineral metabolism and nutrition status in
      peritoneal dialysis patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years

          -  On peritoneal dialysis at least 3 months with a Kt/V of ≥ 1.7

          -  Use of Automated Peritoneal Dialysis

          -  Serum phosphate > 5.5 mg/dL or <5.5 mg/dL on a binder other than velphoro

          -  Serum albumin ≤ 3.7 g/dL

          -  Able to provide consent

          -  Ability to complete self-reported questionnaire

        Exclusion Criteria:

          -  Inadequate dialysis

          -  Current use of sucroferric oxyhydroxide

          -  Significant comorbid conditions that lead the investigator to conclude that life
             expectancy is less than 6 months

          -  Active malignancy

          -  Recent episode of peritonitis

          -  Pregnancy or planning to become pregnant

          -  Anticipated kidney transplantation within 6 months

          -  Factors judged to limit adherence to interventions

          -  Known adverse side effect to sucroferric oxydroxide
Hip Scope Fascia-iliaca (FI) Block Study
Condition: Hip Dysplasia; Femoroacetabular Impingement; Acetabular Labrum Tear
MeSH terms: Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital; Femoracetabular Impingement
Intervention: ropivicaine; clonidine; Epinephrine; Noropin
Intervention MeSH terms: Clonidine; Epinephrine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Hip Arthroscopy

Summary:

      Patients undergoing a hip scope procedure will be recruited for this study. They will be
      randomized to either receive a nerve block or no nerve block (pain medicine only). Pain
      levels and clinical outcomes will be assessed through 3 months post-operatively.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Scheduled for outpatient hip arthroscopy

          -  American Society of Anesthesiologists (ASA) 1-3

        Exclusion Criteria:

          -  Prior surgery on ipsilateral hip

          -  ASA 4-6

          -  Chronic narcotic usage over 6 months or more than the equivalent of 20mg of morphine
             per day

          -  Current or prior placement of a spinal cord stimulator or intrathecal pump for pain
             control purposes

          -  Allergy to amide local anesthetics

          -  Contraindication to regional anesthesia

          -  BMI > 40

          -  Females who are pregnant or plan to get pregnant during the course of the study
A Comparison of Tumescence in Breast Reduction Surgery
Condition: Pain, Postoperative; Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Pain, Postoperative; Postoperative Nausea and Vomiting
Intervention: Tumescent solution with dilute lidocaine and epinephrine; Tumescent Solution with dilute epinephrine
Intervention description: Tumescent Solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000); Tumescent Solution containing dilute epinephrine (1:1,000,000) only
Intervention MeSH terms: Lidocaine; Epinephrine; Racepinephrine; Pharmaceutical Solutions; Epinephryl borate
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pain, postoperative; Postoperative Nausea and Vomiting; Patient Readmission; Time to Discharge

Summary:

      The investigators' main hypothesis is that in breast reduction surgery, the use of tumescent
      solution containing both dilute lidocaine and epinephrine will lead to better control of
      postoperative pain, nausea, vomiting, shorter time through postoperative phases of care,
      quicker discharge from the hospital and lower numbers of hospital readmissions than the use
      of tumescent solution containing only dilute epinephrine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  all patients presenting for breast reduction surgery at the University of Wisconsin
             Hospital and Clinics and the University of Wisconsin Transformations Surgery Center
             and who do not meet any of the exclusion criteria.

        Exclusion Criteria:

          -  Women under the age of 18 years

          -  Breast feeding or pregnant women

          -  Incarcerated women.

          -  Women unable to give consent because of impaired decision making ability.

          -  Women who have reported allergies to the substances that will be used in the study.
Alternative in Beta Blocker Intolerance: The ABBI Trial
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Intervention: Nebivolol
Intervention description: Bystolic (Nebivolol), 5 mg per day for 30 days, titrated up to 10 mg at 2 weeks if necessary for blood pressure control.
Intervention MeSH terms: Nebivolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Intolerance; Beta blocker

Summary:

      In this study the investigators will assess the tolerance of Nebivolol (Bystolic) in
      cardiovascular patients who are not able to tolerate conventional beta blockers. A side
      effect profile will be tracked and compared with previous beta blocker use.

      The investigators hypothesize that Bystolic will be tolerated by many patients who are
      intolerant of conventional blockers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 21

          -  Male or female who is post-menopausal or not pregnant and using an approved
             contraceptive regimen

          -  Previous beta blocker use and intolerant of beta blocker

        Exclusion Criteria:

          -  Systolic blood pressure < 100 mmHg unless another blood pressure medication is stopped
             at the time of study entry

          -  Hospitalized for heart failure within the past 4 weeks

          -  Bradycardia with a heart rate < 60

          -  Heart block greater than first degree

          -  History of sick sinus syndrome (unless a permanent pacemaker is in place)

          -  History of severe hepatic or renal dysfunction; serum Creatinine > 2.0 or Amylase > 3x
             normal

          -  Use of CYP2D6 inhibitors (quinidine, propafenone, fluoxetine, paroxetine, etc.)

          -  Ingestion of investigational drug within the past 30 days
Theracal Pulpotomy in Primary Molars
Condition: Deep Caries
Intervention: Theracal LC; Formocresol
Intervention description: pulpotomy; Pulpotomy
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 4 Years
Maximum age: 7 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Theracal; formocresol; pulpotomy

Summary:

      Light cured silicate based cement (theracal LC) pulpotomy was compared to formocresol
      pulpotomy in primary molars.
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy, cooperative children

          -  mandibular primary molars with vital pulp exposures

        Exclusion Criteria:

          -  clinical or radiographic evidence of irreversible pulpitis

          -  physiological root resorption
Greater Occipital Nerve Block Versus Metoclopramide
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Greater occipital nerve block with bupivacaine; Metoclopramide
Intervention description: This is a type of peripheral nerve block. 3cc of 0.5% bupivacaine will be injected adjacent to the greater occipital nerve block blaterally; Metoclopramide 10mg IV will be administered over 15 minutes
Intervention MeSH terms: Metoclopramide; Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double dummy design with IV placebo and placebo nerve block
Enrollment: 99.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      We are comparing a type of nerve block called greater occipital nerve block versus standard
      therapy among patients who present to an emergency department for acute migraine. This is a
      randomized, double-blind, double dummy study. The greater occipital nerve block will be
      performed bilaterally with bupivacaine 0.5%. Standard therapy is metoclopramide 10mg IV.
    

Eligibility criteria:

        Inclusion Criteria:

        Eligible patients are adults who present with an acute moderate or severe headache meeting
        migraine headache criteria, as defined by the International Classification of Headache
        Disorders-3β (1.1, migraine without aura). Patients who meet criteria for Probable Migraine
        without Aura (1.5.1) will also be included, provided they have had at least one similar
        attack previously.

        Exclusion Criteria:

        Patients will be excluded if informed consent cannot be obtained, if there is concern for a
        secondary cause of headache, if the maximum documented temperature is greater than 100.3
        degrees, for a new objective neurologic abnormality, skull defect, suspected infection
        overlying injection site, known bleeding disorder, ongoing use of anti-platelet agents
        including P2Y12 platelet inhibitors (clopidogrel, prasugrel, ticagrelor), heparins,
        warfarin, or 10a inhibitors (rivaroxaban, apixaban, edoxaban, fondaparinux), prior
        treatment with a greater occipital nerve block, allergy to the investigational medications,
        pheochromocytoma, seizure disorder, Parkinson's disease, use of MAO inhibitors, and use of
        anti-rejection transplant medications.
Evaluation of Prednisolone in a Modified Conjunctival Allergen Challenge Model
Condition: Chronic Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: Prednisolone Sodium Phosphate Ophthalmic Solution 1%; Tears Naturale II Ophthalmic Solution
Intervention description: One drop in each eye, four times/day for 4 days.; one drop in each eye, four times/ day (QID) for 4 days
Intervention MeSH terms: Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Pharmaceutical Solutions; Ophthalmic Solutions; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the effectiveness of the modified Conjunctival
      Allergen Challenge (CAC) and observe how the produced allergic inflammation reacts to
      treatment with a proven ocular anti-inflammatory medication,

      Prednisolone, assessed by the following measures:

      Chronic Allergic Inflammation assessed using confocal microscopy Ocular itching Conjunctival
      redness
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years of age & either sex, any race

          -  Willing and able to follow all instructions

          -  Positive history of ocular allergies

          -  Reproducible positive ocular allergic reaction induced by conjunctival allergen
             challenge

        Exclusion Criteria:

          -  Have planned surgery during trial period

          -  Female currently pregnant, planning a pregnancy or lactating

          -  Use of disallowed medications

          -  Have ocular infections, or ocular conditions that could affect study parameters

          -  Have moderate to severe dry eye

          -  Have used an investigational drug or device within 30 days of start of study

          -  Female that is currently pregnant, planning a pregnancy or lactating
Gene Expression Profile After Gonadotropin Releasing Hormone (GnRH) Agonist Trigger of Oocyte Maturation
Condition: Endometrial Receptivity; Ovarian Hyperstimulation Syndrome
MeSH terms: Ovarian Hyperstimulation Syndrome
Intervention: GnRH agonist; hCG
Intervention description: GnRH agonist 1mg one dose; 5,000 IU one dose
Intervention MeSH terms: Leuprolide
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 7.0
Sex: Female
Minimum age: 21 Years
Maximum age: 33 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: GnRHa trigger; endometrial gene profile; quality of life

Summary:

      The purpose of this study is to compare gene expression profiles in endometrial biopsies
      during the window of implantation after triggers of oocyte maturation using GnRH agonist or
      hCG and compared with their natural cycles in order to identify genes that may be
      dysregulated in GnRH agonist-triggered cycles.

      The investigators also intend to evaluate patients feeling of well being and physical quality
      of life after GnRH agonist trigger compared with hCG trigger.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Oocyte donors

          -  Ages between 21 and 33

          -  Normal baseline serum FSH < 10mIU/mL

        Exclusion Criteria:

          -  Hypothalamic dysfunction

          -  Smokers

          -  Baseline serum FSH ≥ 10mIU/mL
PROlonGed ExpoSure Sertraline
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Sertraline; Prolonged Exposure Therapy
Intervention description: Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.; up to 13 sessions of prolonged exposure
Intervention MeSH terms: Sertraline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 223.0
Sex: All
Healthy volunteers: No
Keywords: combat-related PTSD; Posttraumatic stress disorder; prolonged exposure therapy; sertraline; military; veterans; VA hospital; mental illness

Summary:

      The current research study aims to compare the effectiveness of two proven treatments for
      posttraumatic stress disorder (PTSD): Prolonged Exposure (PE), sertraline, and their
      combination. In addition, the investigators are examining predictors of response to these two
      treatments and how PTSD symptoms, thoughts, and biological factors may be changed by such
      treatments. Biological mechanisms of change are also examined including emotion processing
      and regulation in fMRI, HPA axis function, and genetics and genomics. In addition, the
      investigators will examine acceptability of each treatment and reasons for ending treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is an Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn
             (OEF/OIF/OND) combat veteran with chronic posttraumatic stress disorder (PTSD) or
             significant PTSD symptoms (Clinician Administered Posttraumatic Stress Disorder Scale
             [CAPS] >= 50) of at least 3 months duration

        Exclusion Criteria:

          -  Current, imminent risk of suicide (as indicated on C-SSRS)

          -  Active psychosis

          -  Alcohol or substance dependence in the past 8 weeks

          -  Unable to attend regular appointments

          -  Prior intolerance or failure of adequate trial of prolonged exposure (PE) or
             sertraline (SERT) (defined as at least 2 months of SERT at least 100mg/day)

          -  Medical illness likely to result in hospitalization or for which treatments are
             contraindicated (based on lab results, medical history and physical exam)

          -  Serious cognitive impairment (as evidenced by cognitive impairment felt likely to
             interfere with the ability to participate meaningfully in the study)

          -  Concurrent antidepressants or antipsychotics

          -  Pregnant females
Mechanisms of Lipodystrophy in HIV-Infected Pateints
Condition: HIV Infections
MeSH terms: Lipodystrophy
Intervention: Nelfinavir; Efavirenz
Intervention MeSH terms: Efavirenz; Nelfinavir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: HIV; Lipodystrophy; Treatment Experienced

Summary:

      The metabolic and molecular basis of lipodystrophy syndrome in HIV-infected patients is not
      known. Whether besides protease inhibitors, other antiretroviral drugs, HIV infection and
      reduction in viral load contribute to the development of lipodystrophy syndrome is not clear.

      The project therefore has the following aims: 1) to characterize metabolic abnormalities and
      changes in body fat distribution, 2) to develop objective criteria for defining the syndrome
      and to ascertain prognostic indicators and 3) to elucidate the molecular basis of the
      lipodystrophy syndrome in HIV-infected patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV Positive

          -  No previous antiviral therapy

          -  18 to 70 years of age

        Exclusion Criteria:

          -  Patients with opportunistic infections or AIDS.

          -  Active intravenous drug users.

          -  Patients on corticosteroids, androgens, lipid-lowering drugs, anti-fungal medications,
             dehydroepiandrosterone, oxandrolone, megace.

          -  Patients with diabetes mellitus.

          -  Patients with moderate to heavy alcohol consumption ( greater than 15 drinks per
             week).

          -  Pregnant or premenopausal women, unless surgically sterilized or highly unlikely to
             conceive (defined as women taking oral contraceptives, using barrier protection during
             intercourse or with a copper intrauterine device in place for > 3 months without
             complaints and a negative serum or urine pregnancy test within 30 days of study
             entry).

          -  Acute or chronic liver diseases; elevations of liver transaminases by more than two
             and one half times above the upper limits of normal ( SGOT > 105 U/L, SGPT > 120 U/L,
             ) or a total bilirubin of > 1.5mg/dL.

          -  Anemia (hematocrit <32%).

          -  Abnormal thyroid function tests.

          -  Weight loss >10% from baseline in the past year.

          -  Recent (within the past year), history of suicide attempt.