bioihbjkbjnl/mcl2 huggingface dataset:
Impact of FBB PET Amyloid Imaging in Change of Diagnosis in Patients With AD
Condition: Alzheimer's Disease (AD)
MeSH terms: Alzheimer Disease
Intervention: Neuraceq (florbetaben 18F); PET
Intervention description: Florbetaben 18F is given as an i.v. injection followed by a flush of sodium chloride solution to ensure full delivery of the dose.; A brain PET scan is usually taken 90 minutes after the i.v. injection of florbetaben 18F.
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 218.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: CSF; Alzheimer's Disease (AD) and related dementia; HAS recommendations

Summary:

      This phase 4 study will explore, in the context of the present French clinical practice, the
      impact of florbetaben 18F (FBB) in patients evaluated for AD who require a biomarker for
      etiologic determination of the cognitive and functional impairment, but in whom:

        1. lumbar puncture was not feasible for medical conditions

        2. results of cerebrospinal fluid (CSF) analysis were considered ambiguous by treating
           physicians

        3. lumbar puncture (LP) was refused by the patient
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients being evaluated for Alzheimer disease and related dementias according to the
             HAS recommendations (atypical dementia, early onset and rapid progressive dementia)

          -  Patients who have previously been evaluated for AD and related dementias to whom a CSF
             examination was recommended in the last 12 months, but lumbar puncture was
             contraindicated or refused or CSF results were ambiguous, or

          -  Patients currently being evaluated for AD and related dementias to whom a CSF
             examination is recommended but lumbar puncture is contraindicated or refused

          -  Patients have a study partner who is willing and able to accompany him/her to all
             clinic visits for the duration of the protocol

          -  Patients able to complete all clinical visits according to the protocol

          -  Patients able to tolerate a 20-minute FBB PET scan

          -  Patient or legal representative to provide informed consent for study participation,
             visits and data source verification.

        Exclusion Criteria:

          -  The subject had a previous beta amyloid imaging scan

          -  Any significant systemic illness or unstable medical condition which could lead to
             difficulty complying with the protocol

          -  Is currently receiving any investigational pharmaceutical product or has participated
             in a clinical trial with an investigational pharmaceutical product within 30 days
             prior to screening and/or was administered a radiopharmaceutical within 10 radioactive
             half-lives prior to study drug administration in this study

          -  For females of childbearing age, a positive pregnancy test
Treatment of Acne Vulgaris With Doryx Tablets Compared to Doxycyline Hyclate
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Doxycycline hyclate (Doryx); Doxycycline hyclate
Intervention description: 150mg/day, oral, delayed release tablets; 100 mg/day, oral, tablets, immediate release
Intervention MeSH terms: Doxycycline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 93.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      Randomized, multi-center, open label, active-comparator study to compare the efficacy and
      tolerability of Doryx Delayed Release Tablets to doxycycline hyclate in patients with
      moderate to severe acne vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be 12 years of age or older.

          -  Has a diagnosis of facial acne vulgaris with no more than two nodules on the face.

        Exclusion Criteria:

          -  Is allergic to tetracycline-class antibiotics or to any ingredient in the study
             medication.

          -  Has a history of pseudomembranous colitis or antibiotic-associated colitis.

          -  Has a history of hepatitis or liver damage or renal impairment.
Low Dose Fat for the Prevention of Liver Disease in Babies With Gastrointestinal Disorders
Condition: Cholestasis
MeSH terms: Cholestasis; Gastrointestinal Diseases; Digestive System Diseases
Intervention: Intralipid; Intralipid
Intervention description: The subject will receive 1 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first.; The subject will receive 3 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first.
Intervention MeSH terms: Soybean oil, phospholipid emulsion
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 1 Minute
Maximum age: 5 Days
Healthy volunteers: No
Keywords: cholestasis; neonates; parenteral nutrition; gastrointestinal disorders

Summary:

      Neonates with congenital/acquired gastrointestinal disorders are at high risk for Parenteral
      Nutrition Associated Cholestasis (PNAC). Besides enteral nutrition, standard therapies to
      prevent and treat PNAC have been limited and marginal. Recently, the dose and composition of
      standard intravenous fat emulsions have implicated in the development and progression of
      PNAC.

      In this study, neonates with congenital/acquired gastrointestinal disorders will be
      randomized, in a unblinded fashion, to receive either the standard dose of an intravenous
      omega-6 fatty acid emulsion or a low dose of an intravenous omega-6 fatty acid emulsion
      throughout their course of PN or until hospital discharge, death or 100 days of life,
      whichever comes first. The primary outcome will be the presence of cholestasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  congenital or acquired gastrointestinal disorder

          -  age less than 5 days of life

        Exclusion Criteria:

          -  congenital intrauterine infection know to be associated with liver involvement

          -  known structural liver abnormalities

          -  known genetic disorders (trisomy 21, 13, and 18)

          -  inborn errors of metabolism

          -  infants meeting the criteria for terminal illness (ph:6.8>2 hours)
Oral Ketorolac for Pain Relief During IUD Insertion
Condition: Contraception
Intervention: Ketorolac; Placebo
Intervention description: Oral Tablet; Oral Tablet
Intervention MeSH terms: Ketorolac
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 71.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: intrauterine device

Summary:

      Ketorolac is a non-steroidal anti-inflammatory drug (NSAID), similar to ibuprofen but it is
      used to treat more severe pain. Ketorolac (Trade name: Toradol) is typically used after
      surgical procedures. When taken orally, it should not cause sedation. The purpose of this
      study is to determine if oral ketorolac is effective at reducing pain during IUD placement
      versus a placebo tablet.
    

Eligibility criteria:

        Inclusion Criteria:

          -  non-pregnant

          -  English speaking women

          -  18 years of age or older desiring an IUD for contraception

        Exclusion Criteria:

          -  enrollment in another study

          -  pre-medication with any type of analgesic medication

          -  contraindication to an IUD

          -  weight under 50 kg

          -  allergy to non-steroidal anti-inflammatory medications

          -  past medical history of liver disease, renal disease, peptic ulcer disease or recent
             gastrointestinal bleed,

          -  daily narcotic pain use

          -  positive cultures for gonorrhea or chlamydia.
The Effect of Donepezil on Gait and Balance in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Donepezil; Placebo
Intervention description: Use 1 capsule (5 mg) of donepezil once per day for first 21 days than donepezil 10mg qday for 21 days.; Use 1 capsule (5 mg) once per day for first 21 days than 10mg qday for 21 days.
Intervention MeSH terms: Donepezil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 21.0
Sex: All
Healthy volunteers: No
Keywords: donepezil; parkinson's disease; balance; cholinesterase inhibitor

Summary:

      This study involves Parkinson's disease (PD). Symptoms include slow movement, tremor, and
      muscle rigidity. Current medications for the treatment of PD do not improve gait and balance
      difficulties in individuals with PD. Donepezil (study drug) has been found to reduce falls in
      individuals with PD. The mechanism in which this reduction of falls occurs is unclear. The
      investigators study will look at what aspects of gait and balance are improved by the study
      drug. The study drug is not approved to treat PD in the United States or other countries
      because we do not know enough about it.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Idiopathic Parkinson's disease, defined by the UK Brain Bank criteria, with a Hoehn
             and Yahr score of 2 to 4

          -  Treated with levodopa for at least a year and on a stable antiparkinsonian regimen for
             at least one month

          -  Abnormal computerized dynamic posturography (CDP) on screening defined as a composite
             score below 65 (range 1-100)

        Exclusion Criteria:

          -  Dementia defined by MMSE less than 27

          -  Other medical conditions other than PD affecting balance or gait as determined by the
             investigators

          -  Unable to stand unassisted for 30 minutes

          -  Current use of an acetylcholinesterase inhibitors or drugs with known anticholinergic
             properties

          -  Medical or psychiatric co-morbidities that may interfere with compliance or might
             place subject in danger as determined by the investigators
A Study of Rivaroxaban for Early Discharge of Low Risk Pulmonary Embolism From the Emergency Department
Condition: Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Embolism; Emergencies
Intervention: Rivaroxaban; Standard-of-care
Intervention description: Participants will receive Rivaroxaban 15 milligram (mg) twice daily up to Days 21 by orally and Rivaroxaban 20 mg once daily up to Days 90 by orally.; Standard-of-care as per local protocol and defined by the medical team caring for the participant.
Intervention MeSH terms: Rivaroxaban
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 114.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rivaroxaban; JNJ39039039; Pulmonary embolism

Summary:

      The purpose of the study is to evaluate that low risk Pulmonary Embolism (PE) participants
      who are discharged from the Emergency Department (ED) to the home environment and treated
      with rivaroxaban as outpatients have fewer total days in the hospital for bleeding and/or
      venous thromboembolism (VTE) events through Day 30 compared to participants who are treated
      with initial hospitalization and standard-of-care.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have confirmed acute symptomatic Pulmonary Embolism (PE) with or without symptomatic
             deep vein thrombosis (DVT)

          -  A PE participant diagnosed in the Emergency Department (ED) who is deemed to be at low
             risk of clinical deterioration as determined by the Hestia criteria

          -  Have no contraindications to and be able to complete randomized treatment and all
             study assessments

          -  Have a life expectancy of at least 6 months

          -  Must be willing and able to adhere to the prohibitions and restrictions specified in
             this protocol

        Exclusion Criteria:

          -  Having received any Combined P-gp (P-glycoprotein) and strong CYP3A4 (Cytochrome P450)
             inhibitors (such as but not limited to ketoconazole, telithromycin or protease
             inhibitors) use within 4 days before randomization, or planned use during the study.
             Itraconazole use within 7 days before randomization or planned use during the study

          -  Having received any Combined P-gp and strong CYP3A4 inducers (such as but not limited
             to rifampin/rifampicin, rifabutin, rifapentine, phenytoin, phenobarbital,
             carbamazepine, or St. John's Wort) use within 2 weeks before randomization or planned
             use during the study

          -  Who Has contraindications to the use of any anticoagulant therapy (example, bleeding
             diathesis, history of gastrointestinal bleeding within 1 year or coagulopathy
             documented at Screening)

          -  Who Has known allergies, hypersensitivity, or intolerance to rivaroxaban or its
             excipients

          -  Woman who is pregnant, or breast-feeding, or planning to become pregnant
Perineural Steroids for Peripheral Nerve Blocks
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee
Intervention: Dexamethasone; Bupivacaine; Epinephrine; Saphenous Peripheral Nerve Block
Intervention description: Used in nerve block mixture; Used in nerve block mixture; Used in nerve block mixture; Peripheral nerve block.
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Epinephrine; Bupivacaine; Dexamethasone 21-phosphate; BB 1101
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 85.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Anesthesia; Anesthesia, Conduction; Anesthesia, Local; Bupivacaine; Dexamethasone; Saphenous; Adductor Canal; Nerve Block; Analgesia; Preanesthetic Medication; Perioperative Period; Peripheral Nerve Block

Summary:

      This study will look at the efficacy of dexamethasone for prolongation of peripheral nerve
      blocks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  elective robotic medial MAKO partial knee arthroplasty

          -  agreed to a regional anesthesia technique

        Exclusion Criteria:

          -  contraindications to regional anesthesia

          -  presence of a progressive neurological deficit

          -  a pre-existing coagulopathy, infection

          -  insulin and non-insulin dependent diabetes mellitus

          -  systemic use of corticosteroids within 30 days of surgery

          -  chronic use of an opioid analgesic (>3 months or a combined total of more than 40 mg
             Oxycodone equivalents a day)

          -  pregnancy

          -  a prior history of an adverse event (for example: psychosis) or an allergy to
             dexamethasone
A Study to Evaluate the Efficacy and Tolerability of Topical Therapies for the Condition of Plaque-Type Psoriasis
Condition: Plaque-Type Psoriasis
MeSH terms: Psoriasis
Intervention: Olux-E Foam; Clobex lotion
Intervention description: Olux-E (clobetasol propionate 0.05%) foam. Starting at baseline, subjects were to apply twice daily Olux-E foam to the affected elbows and/or knees up to day 15.; Clobetasol propionate 0.05% lotion. Starting at baseline, subjects were to apply twice daily Clobex lotion to the affected elbows and/or knees up to day 15
Intervention MeSH terms: Clobetasol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriasis

Summary:

      The purpose of the study is to determine the efficacy and safety of two different forms of a
      topical steroid (clobetasol propionate) in patients with plaque-type psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body surface area (BSA) affected with psoriasis between 4% and 20% .

          -  Target lesion of at least 2 cm² on the elbow and/or knee, with a score of 2 or 3 on
             the Psoriasis Grading Scale for Target Lesion.

          -  Elbow and/or knee plaque-type psoriasis with a Psoriasis Global Assessment of mild or
             moderate (2 or 3).

          -  Definitive diagnosis of elbow and/or knee plaque-type psoriasis.

          -  Capable of understanding and willing to provide a signed and dated written voluntary
             informed consent (and any local or national authorization requirements) before any
             protocol-specific procedures were performed.

          -  Male or female, 18 years of age or older at the time that the consent form was signed.

          -  Able to complete the study and comply with study instructions.

          -  Female subjects of childbearing potential must have had a negative pregnancy test.
             Sexually active women of childbearing potential participating in the study must have
             been using a medically acceptable form of contraception.

        Exclusion Criteria:

          -  Use of any emollient applied to psoriasis plaques treated with the study medication
             during the study.

          -  Other serious skin disorder or any chronic medical condition that is not well
             controlled.

          -  Female subjects who are pregnant, trying to become pregnant or lactating.

          -  Any major illness within 30 days prior to the baseline visit.

          -  Received any investigational drug or treatment within 30 days of the baseline visit or
             who are scheduled to receive an investigational drug or treatment other than the study
             products during the study.
Safety, Efficacy, and Side Effects Study of Interventional Cryotherapy in the Pleural Space("ICE PLS")
Condition: Cancer; Pleural Neoplasms
MeSH terms: Neoplasms; Pleural Neoplasms
Intervention: CryoSpray Ablation (TM) System
Intervention description: Subjects will be treated with spray cryotherapy using the CryoSpray Ablation (TM) System at Day 0 using up to 3 cycles of 10-40 second sprays as the studied dosimetry and will cover the affected area, including the tumor and the parietal pleural surface. If disease exists bilaterally, only one side will be sprayed. Subjects will be assessed 2-5 days from the initial treatment (Day 0) to check for mucosal sloughing, to reassess tumor burden and for additional CSA therapy as needed.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Parietal pleura; Neoplasms; Pleural Surface; Pleural Neoplasms; Lung Cancer

Summary:

      The purpose of this study is to evaluate the safety, efficacy, and side effects of the
      CryoSpray Ablation(TM) System (CSA(TM) System) to treat neoplastic lesions on the parietal
      pleural surface.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age

          -  Deemed a candidate for cryotherapy based on physician physical or medical history
             review

          -  Deemed operable based on institutional criteria

          -  Able to sign informed consent

          -  Documented lung or other visceral cancer with pleural involvement.

          -  WBC > 4,000/mm3, platelets >100,000mm3

          -  Physically well enough to undergo moderate sedation and pleuroscopy

          -  Female patients must be HCG negative

          -  There should be direct evidence of disease progression despite treatment in previously
             treated patients

        Exclusion Criteria:

          -  Pregnant or nursing

          -  Planning to sire a child while enrolled in the study

          -  Known history of unresolved drug or alcohol dependency that would limit ability to
             comprehend or follow instructions related to informed consent, post-treatment
             instructions, or follow-up guidelines.

          -  Refusal or inability to give consent.

          -  Concurrent chemotherapy.

          -  Medical contraindication or potential problem that would preclude study participation

          -  Concurrent participation in other experimental studies

          -  Uncontrolled coagulopathy or bleeding diathesis

          -  Serious medical illness, including:

          -  Uncontrolled congestive heart failure

          -  Uncontrolled angina

          -  Myocardial infarction

          -  Cerebrovascular accident within 6 months prior to study entry
Advance Supply of Emergency Contraception Compared to Routine Postpartum Care in Teens
Condition: Post Partum
MeSH terms: Emergencies
Intervention: Plan B (Levonorgestrel)
Intervention description: PP TEENS ARE RANDOMIZED TO PLAN B + ROUTINE CONTRACETIVE CARE VS. ROUTINE CARE ALONE. QUESTIONNAIRES ON HEALTH STATUS, SEXUAL HISTORY, AND CONTRACEPTIVE USE ARE COMPLETED AT STATED INTERVALS.
Intervention MeSH terms: Levonorgestrel
Phase: Phase 4
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: Female
Minimum age: 14 Years
Maximum age: 19 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Teen; Plan B; Post Partum; Emergency Contraception

Summary:

      This is a pilot randomized controlled trial to assess the effects of advanced supply of
      emergency contraception versus routine care in a teen postpartum population. The goals are to
      assess feasibility of recruiting and retaining postpartum teens; to obtain estimates of the
      prevalence of (use of Plan B, primary contraceptive continuation, unprotected intercourse
      exposure, and pregnancy rates), in postpartum teens given advanced supply of Plan B; to
      assess whether or not (lack of use of Plan B, contraceptive method non-continuation, and
      unprotected intercourse exposure), are surrogate markers for risk of unintended pregnancy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Female

          2. English speaking

          3. Aged 14-19 at enrollment

          4. Immediately postpartum of a live infant

          5. Planning to parent the baby

          6. Desiring to delay another pregnancy for at least one year

          7. General good health

          8. Willing and able to follow the study protocol

        Exclusion Criteria

          1. Allergy to levonorgestrel

          2. Current substance abuse

          3. Plans for relocation outside of Philadelphia