bioihbjkbjnl/mcl2 huggingface dataset:
Oracea Soolantra Association in Participants With Severe Rosacea
Condition: Rosacea
MeSH terms: Rosacea
Intervention: Ivermectin 1% cream; Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules; Oral placebo capsules
Intervention description: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks; 1 Capsule once-daily for 12 weeks; 1 Capsule once-daily for 12 weeks
Intervention MeSH terms: Doxycycline; Ivermectin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 273.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main objective of this study is to evaluate the efficacy of Ivermectin 1% topical cream
      associated with Doxycycline 40 mg Modified release (MR) capsules versus Ivermectin 1% topical
      cream associated with Placebo in the treatment of severe Rosacea.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subject age ≥ 18 years or older;

          -  Subject with a minimum of 20 but not more than 70 inflammatory lesions (papules and
             pustules) of rosacea on the face at Baseline visit;

          -  Subject with severe rosacea with papulopustular lesions (according to the
             Investigator's Global Assessment (IGA) score rated 4);

          -  Female subjects of childbearing potential with a negative urine pregnancy test (UPT);

          -  Female subjects of childbearing potential must practice a highly effective method of
             contraception during the study.

        Exclusion Criteria:

          -  Subjects with particular forms of rosacea or other concomitant facial dermatoses that
             may be confounded with rosacea;

          -  Subjects with more than 2 nodules of rosacea on the face;

          -  Subjects with any uncontrolled chronic or serious disease or medical condition that
             may either interfere with the interpretation of the clinical trial results, or with
             optimal participation in the study or would present a significant risk to the subject;

          -  Subjects with known or suspected allergies or sensitivities to any component of the
             investigational and non-investigational products, including the active ingredients
             doxycycline and ivermectin.
Open-label, Multi-center Trial of Zonisamide as Adjunctive Therapy in Patients With Uncontrolled Partial Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy; Epilepsies, Partial
Intervention: zonisamide
Intervention description: zonisamide 100 mg tablet
Intervention MeSH terms: Zonisamide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 121.0
Sex: All
Minimum age: 15 Years
Healthy volunteers: No

Summary:

      The object of this study is to assess the efficacy and safety of zonisamide as adjunctive
      therapy in patients with uncontrolled partial epilepsy.
    

Eligibility criteria:

        Inclusion criteria:

          1. Epilepsy patient over 15 years old who agrees with Informed Consent Form

          2. Patient who has classifiable uncontrolled partial epilepsy according to International
             Classification of Epileptic Seizures.

          3. Patient who has 3 ~ dozens of partial seizure (average more than once seizure per 4
             weeks) last 12 weeks despite taking 1 ~ 3 antiepileptic drug(s).

          4. Patient who takes 1 ~ 3 marketed antiepileptic drug(s) excluding zonisamide at point
             of enrollment time.

          5. Before study visit, patient who takes stable dose of antiepileptic drug more than 4
             weeks.

        Exclusion criteria:

          1. Patient who has progressive central nervous system (CNS) disorder and/or degenerative
             disease of the brain.

          2. Patient who experiences pseudoseizures and/or who has uncountable clusters.

          3. Patient who has serious systemic or drug metabolism affecting disorder .

          4. Upward of doubled normal glutamic oxaloacetic transaminase (GOT), glutamic pyruvic
             transaminase (GPT), bilirubin, blood urea nitrogen (BUN), creatinine levels.

          5. Patient who has absolute neutrophil counts <1800/mm3 or platelets <100,000/mm3.

          6. Patient who has medical history of renal stones.

          7. Patient who is allergic to sulfonamide.

          8. Medical history of medicinal poisoning and/or alcoholism and/or serious psychological
             disorder.

          9. Pregnant women, lactating women, women of childbearing age who do not use a preventive
             method of conception.

         10. A terminal patient and/or a scheduled surgical patient.

         11. Patient who has medication history of zonisamide.

         12. Patient who participated other clinical trial within the last 12 weeks at point of
             enrollment time of this study.
Steady-state Pharmacokinetics of Ceftazidime/Avibactam in Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Ceftazidime/avibactam
Intervention description: Ceftazidime/avibactam 2.5gm iv q8h for 3 doses
Intervention MeSH terms: Ceftazidime; Avibactam; Avibactam, ceftazidime drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pharmacokinetics; ceftazidime/avibactam

Summary:

      The purpose of this research study is to characterize the pharmacokinetics of intravenous
      ceftazidime/avibactam in patients with Cystic Fibrosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of CF based on positive sweat chloride or know CF mutation

          -  Age > 17 years

          -  Able to spontaneously expectorate sputum

        Exclusion Criteria:

          -  Any clinically significant laboratory abnormality

          -  Presence of an ongoing acute pulmonary exacerbation

          -  Pregnancy

          -  Serious past allergy to a beta-lactam antibiotic
Senescent Immunity in Elders and Vaccine Responses (SILVER)
Condition: Flu Vaccine
Intervention: Fluzone-High Dose Quadrivalent; Fluad; Flublock
Intervention description: Seasonal influenza vaccination with FDA approved vaccines for this age group.; Adjuvanted (MF59) inactivated influenza vaccine; Recombinant hemagglutinin vaccine
Intervention MeSH terms: Hemagglutinins; Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking description: This is an open label trial, the study nurse and participant know which of 3 FDA approved influenza vaccines are given (Fluzone-HD, FluAd, or Flublok). However the investigator and outcomes assessor are blinded to the actual vaccine given.
Enrollment: 10.0
Sex: All
Minimum age: 65 Years
Maximum age: 125 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: adult 65 and older

Summary:

      To study the effects of age on the immune system's response to flu vaccine and to study the
      connection between the immune system and physical and cognitive changes associated with
      aging.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 65 years and over

          -  Independent Living (including Assisted Living)

        Exclusion Criteria:

          -  Unable to understand the consent or the study.

          -  Allergic to any vaccine components, excluding eggs.

          -  History of Guillain-Barre.

          -  Residing in a long -term care facility such as a nursing home.
Boston Scientific OffRoad™ Re-entry Catheter System for Subintimal Recanalization of Chronic Total Occlusions in Femoropopliteal Arteries
Condition: Chronic Total Occlusion
Intervention: OffRoad Re-entry Catheter System
Intervention description: Facilitate the placement and positioning of guidewires within the peripheral vasculature.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 92.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Study of the OffRoad™ Re-entry Catheter System for subintimal recanalization of chronic total
      occlusions in native femoropopliteal arteries.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Claudication or critical limb ischemia (Rutherford Category 2-5)

          -  Documented de novo or re-occluded Chronic Total Occlusion (CTO) (99-100% stenosed)
             lesion in native femoropopliteal artery

          -  Target vessel occlusion length is ≥ 1 cm and ≤ 30 cm

          -  Minimum reference vessel diameter is 4 mm

        Exclusion Criteria:

          -  Contraindication to an endovascular procedure

          -  Previous stent placement in the target vessel

          -  Prior surgery of the superficial femoral artery (SFA) in the target limb to treat
             atherosclerotic disease

          -  Platelet count <150,000 mm3 or >600,000 mm3

          -  Renal insufficiency with a serum creatinine >2.3 mg/dl

          -  History of major amputation (ankle level or above) in the same limb as the target
             lesion

          -  Current participation in another drug or device clinical study
Are the "Cardiac Benefits" of Empagliflozin Independent of Its Hypoglycemic Activity? (ATRU-4).
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Intervention: Empagliflozin; Placebos
Intervention description: 6 months; placebo equivalent for 6 months
Intervention MeSH terms: Empagliflozin
Phase: Phase 4
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
Healthy volunteers: No
Keywords: Cardiovascular diseases; Heart Failure; LV remodeling; SGLT-2 Inhibitors; Empagliflozin; Cardiac MRI

Summary:

      Purpose:

      The overall hypothesis of the study is that the benefits attained in the EMPA-OUTCOME were,
      at least in part, mediated by a glucose-independent mechanism. Thus, to demonstrate the
      existence of the postulated non-glucose dependent effects, the researchers will investigate
      the safety and efficacy of empagliflozin versus placebo on top of guideline-directed medical
      therapy in heart failure patients with reduced ejection fraction without diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients should meet the following inclusion criteria:

          -  Ambulatory patients age 18-85 years

          -  Diagnosis of Heart failure (NYHA II to III)

          -  LVEF<50% on echocardiography or CMRI in the previous 6 months

          -  Have stable symptoms and therapy for HF within the last 3 months.

        Exclusion Criteria:

          -  Pregnant or lactating women.

          -  Any history of diabetes by medical history or by any of the established criteria by
             the American Diabetes Association. It also includes patients with history of diabetes
             in remission.

          -  ACS or cardiac surgery within the last 3 months.

          -  Cancer or any other life-threatening condition.

          -  Pancreatitis.

          -  Glomerular Filtration Rate < 45 ml/Kg/min.

          -  Use of continuous parental inotropic agents.

          -  Systolic BP < 90 mm Hg.

          -  Psychiatric disease incompatible with being in study.

          -  Any contraindication to MRI procedures.

          -  Any other medical or physical condition considered to be inappropriate by a study
             physician.
Open-Label Safety Study to Evaluate Imiquimod Cream, 5% for Large Areas of Actinic Keratosis
Condition: Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: imiquimod cream
Intervention description: imiquimod 5% cream applied in doses ranging from one packet (12.5 mg) to 6 packets (75 mg) to either single or multiple body regions for up to 3 cycles
Intervention MeSH terms: Imiquimod
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 551.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: actinic keratosis lesions large head torso extremities; actinic keratosis

Summary:

      Actinic keratosis (AK) is a skin condition that shows up on skin routinely exposed to the
      sun, such as the face, scalp, shoulders, chest, back, arms, and hands. The purpose of this
      study is to evaluate the safety of one, two, or three cycles of imiquimod for the treatment
      of AK. The AK lesions treated can be in adjacent and nonadjacent areas of the head, torso,
      and extremities. The total surface area for the AK lesions must be greater than 25 cm2. The
      secondary objective is to evaluate the effectiveness of treatment with imiquimod in people
      with large surface areas of AK.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are at least 18 years of age.

          -  Have greater than 25 cm2 total treatment area(s) containing at least 4 actinic
             keratosis lesions.

        Exclusion Criteria:

          -  Have any skin condition in the treatment area that may be made worse by treatment with
             imiquimod (e.g., rosacea, psoriasis, atopic dermatitis, eczema).

          -  Have received specific treatments/medications in the treatment area(s) within the
             designated time period prior to study treatment initiation.
Functional Melatonin Replacement for Sleep Disruptions in Individuals With Tetraplegia
Condition: Insomnia; Spinal Cord Injury; Tetraplegia; Sleep Disorders
MeSH terms: Spinal Cord Injuries; Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders; Quadriplegia
Intervention: Ramelteon; Placebo
Intervention description: 8 mg nightly; Nightly 8mg of placebo (same appearance as ramelteon)
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: sleep; melatonin; spinal cord injury; insomnia; tetraplegia

Summary:

      The purpose of this study is to determine if replacing melatonin function with a melatonin
      agonist (ramelteon) in individuals that lack endogenous melatonin production (tetraplegia)
      helps to alleviate self-reported sleep disruption.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years or older, male or female veterans of any racial or ethnic group

          -  Neurologically complete (Frankel A or B) damage to the lower (C4-C8) cervical spinal
             cord

          -  Absence of melatonin production

          -  Time since SCI is greater than 6 months [no cases of acute spinal cord injury]

          -  Subjective complaint of sleep disruption

        Exclusion Criteria:

          -  Current use of fluvoxamine (Luvox , antidepressant), rifampin (antimycobacterial),
             ketoconazole (Nizoral , antifungal), or fluconazole (Diflucan , antifungal) [these
             interact with the same liver enzyme that is the primary metabolizer of ramelteon]; use
             of sleep medications is okay

          -  Hepatic dysfunction

          -  Concomitant use of over-the-counter melatonin

          -  Pregnancy or breast feeding

          -  Currently or have within the past six months met DSM-IV (Diagnosis and Statistical
             Manual IV) criteria for drug or alcohol abuse or dependence or AUDIT score >19

          -  Acute illness or unstable chronic illness. Use of continuous positive airway pressure
             (CPAP) for treatment of sleep apnea is acceptable.

          -  No travel across three or more time zones within three weeks or during the protocol

          -  Illiterate or unable to read or write English or are judged by the investigator to be
             unable or unlikely to follow the study protocol
Evaluation of the Efficacy and Tolerability of Clobetasol Propionate Foam Compared to Vehicle Foam
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Clobetasol propionate foam; Vehicle foam
Intervention description: Topical Clobetasol propionate foam; Vehicle foam does not include the active drug.
Intervention MeSH terms: Clobetasol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 58.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Psoriasis; Plaque Type Psoriasis

Summary:

      The purpose of the study is to compare the efficacy and safety of Clobetasol propionate to
      that of its Vehicle in the treatment of mild to moderate plaque-type psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatient, male or female of any race, and at least 12 years of age. Female subjects
             of childbearing potential must have a negative urine pregnancy test result at baseline
             and practice a reliable method of contraception throughout the study.

          -  Mild to moderate, plaque-type psoriasis

          -  Target lesion on the trunk or extremities (excluding palms/soles, elbows, or knees)
             with a score of 2 or 3 for each of erythema, scaling and plaque thickness

          -  Able to understand the requirements of the study and sign Informed Consent/HIPAA
             Authorization Forms. Subjects under the legal age of consent in the state where the
             study is conducted must also have the written, informed consent of a parent or legal
             guardian.

        Exclusion Criteria:

          -  Female subjects who are pregnant (positive urine pregnancy test) breast feeding or who
             are of childbearing potential and not practicing a reliable method of birth control

          -  Known allergy to clobetasol propionate or other topical corticosteroids; or to any
             component of the investigational formulations

          -  Subjects who have not complied with the proper wash-out periods for prohibited
             medications

          -  Medical condition that in the opinion of the investigator, contraindicates the
             subject's participation in the clinical study

          -  Skin disease/disorder that might interfere with the study related diagnosis or
             evaluations

          -  Evidence of recent alcohol or drug abuse

          -  History of poor cooperation, non-compliance with medical treatment or unreliability
Intravenous Ketorolac for Postoperative Pain in Laparoscopic Donor Nephrectomy
Condition: Nephrectomy; Laparoscopic Donor Nephrectomy
MeSH terms: Pain, Postoperative
Intervention: Ketorolac; Placebo
Intervention description: 90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.; 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
Intervention MeSH terms: Ketorolac
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 111.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: laparoscopic; donor; nephrectomy

Summary:

      The purpose of this study is to determine whether continuous intravenous ketorolac infusion
      reduces pain in patients who are having laparoscopic surgery to donate a kidney.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients donating a kidney via laparoscopic donor nephrectomy

        Exclusion Criteria:

          -  History of NSAID allergy

          -  Asthma

          -  History of long term opioid use

          -  Intraoperative blood loss greater than 300 mL

          -  Postoperative hemodynamic instability

          -  Active peptic ulcer disease

          -  Advanced renal impairment (Cr > 2.0 mg/dL)

          -  Bleeding diathesis

          -  Current use of probenecid

          -  Pregnancy
Memantine and Antipsychotics Use
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Memantine
Intervention description: memantine tablets, twice a day (bid), for 20 weeks
Intervention MeSH terms: Memantine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      To investigate the potential to reduce concomitant antipsychotic medication use in subjects
      with moderate dementia of Alzheimer's type, treated with memantine.
    

Eligibility criteria:

        Inclusion criteria:

          -  Current diagnosis of probable Alzheimer's disease consistent with NINCDS-ADRDA
             criteria or with DSM IV TR criteria for Dementia of the Alzheimer's type.

          -  MRI or CT scan supporting the diagnosis of DAT without indications of any relevant
             other CNS disorders.

          -  Patients treated with any acetylcholinesterase inhibitor (AChEI) man be included.

          -  The patient should have German as a mother-tongue or at least speak the language
             fluently.

        Exclusion criteria:

          -  Evidence (including CT/MRI results) of any clinically significant central nervous
             system disease other than Alzheimer's disease.

          -  Modified Hachinski Ischemia score greater than 4 at screening.

          -  Intake of any medication that is contra-indicated in combination with memantine.

          -  Treatment with depot antipsychotics.

          -  History of severe drug allergy, or hypersensitivity, or patients with known
             hypersensitivity to memantine, amantadine or lactose.

          -  Known or suspected history of alcoholism or drug abuse within the past 10 years.

          -  Previous treatment with memantine or participation in an investigational study with
             memantine.