bioihbjkbjnl/mcl2 huggingface dataset:
Curcumin Therapy to Treat Vascular Dysfunction in Children and Young Adults With ADPKD
Condition: Polycystic Kidney, Autosomal Dominant
MeSH terms: Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Intervention: Curcumin; Placebo
Intervention description: Dietary Supplement
Intervention MeSH terms: Curcumin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 68.0
Sex: All
Minimum age: 6 Years
Maximum age: 25 Years
Healthy volunteers: No

Summary:

      The proposed research will determine the effectiveness of curcumin for improving the health
      and function of arteries in children and young adults with autosomal dominant polycystic
      kidney disease (ADPKD). The study also will provide insight into how curcumin improves artery
      health by determining the physiological mechanisms (biological reasons) involved and offer
      exploratory evidence if curcumin can slow kidney growth. This will be done by comparing these
      measurements in children and young adults who are randomized to receive either curcumin or
      placebo for 1 year.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ADPKD diagnosis

          -  Normal renal function (estimated glomerular filtration rate >80 mL/min/1.73m^2)

          -  Ability to provide informed consent

        Exclusion Criteria:

          -  Currently taking a curcumin supplement

          -  Current smoking or history of smoking in the past 12 months

          -  Marijuana use within 2 weeks prior to FMDBA and aPWV testing

          -  Antioxidantand/or omega-3 fatty acid use within the past 4 weeks prior to FMDBA and
             aPWV testing and for the duration of the study

          -  Alcohol dependence and abuse

          -  History of hospitalization within the last 3 months

          -  Active infection or antibiotic therapy

          -  Pregnancy, lactation, or unwillingness to use adequate birth control

          -  Body-mass index >95th percentile in ages 6-17 or >40 kg/m2 in ages 18-25

          -  Inability to cooperate with/clinical contraindication for MRI including severe
             claustrophobia, implants, devices, or non-removable body piercings
SUBLOCADE Rapid Initiation Extension Study
Condition: Opioid Use Disorder, Severe; Opioid Use Disorder, Moderate
MeSH terms: Opioid-Related Disorders; Substance-Related Disorders
Intervention: Sublocade
Intervention description: SUBLOCADE to be administered approximately every 4 weeks per local standard of care
Intervention MeSH terms: Buprenorphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: After an initial injection of 300mg SUBLOCADE, all subjects will receive SUBLOCADE doses of 100mg or 300mg based on the medical judgement of the Investigator
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A single center, open-label SUBLOCADE treatment extension study in which up to 25
      participants diagnosed with moderate to severe opioid use disorder (OUD) could be enrolled.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed the informed consent form (ICF) and have the ability to comply with the
             requirements and restrictions listed therein.

          -  Completed the EOT Visit for the INDV-6000-403 Study.

          -  Is an appropriate candidate in the opinion of the Investigator or medically qualified
             sub-Investigator.

        Exclusion Criteria:

          -  Subject compliance issues during participation in the INDV-6000-403 study which, in
             the opinion of the Investigator, could potentially compromise subject safety.

          -  Subjects who are unable, in the opinion of the Investigator or Indivior, to comply
             fully with the study requirements including those who are currently incarcerated or
             pending incarceration legal action.
Omega Tots: A Randomized, Controlled Trial of Long-chain Polyunsaturated Fatty Acid Supplementation of Toddler Diets and Developmental Outcomes
Condition: Preterm Birth; Child Development
MeSH terms: Premature Birth
Intervention: Docosahexaenoic Acid + Arachidonic Acid (DHA+AA); Placebo
Intervention description: 200 mg DHA+ 200 mg AA per day for 6 months; 400 mg corn oil per day for 6 months
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 377.0
Sex: All
Minimum age: 10 Months
Maximum age: 16 Months
Healthy volunteers: No

Summary:

      The purpose of this study is to examine whether supplementation with certain polyunsaturated
      fatty acids can help the cognitive development of children born preterm.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 10-16 completed months (age corrected for prematurity) at baseline

          2. Discontinued regular breastfeeding and formula feeding at the time of randomization

          3. Gestational age < 35 completed weeks at birth

          4. English is primary language in home

          5. Informed consent obtained and signed

          6. Child admitted to any NCH managed NICU or children who have ever had a Neonatology
             Clinic follow up visit scheduled, regardless of attendance

        Exclusion Criteria:

          1. Feeding problems

          2. Major malformation, metabolic, or digestive disorder that would preclude participation
             and/or optimal absorption of the supplement.

          3. Weight < 5th or > 95th percentile for age, per WHO growth charts

          4. Consume DHA supplement drops, chews, or powders or Pediasure, or fatty fish more than
             2x per week

          5. Plans to move out of the area within the next 6 months

          6. Known corn allergy

          7. Known soy allergy

          8. Known fish allergy
Smoking Cessation Study In Healthy Adolescent Smokers
Condition: Smoking Cessation
Intervention: Varenicline 1mg BID; Varenicline 0.5mg BID; Placebo
Intervention description: Oral Varenicline 1mg BID, or 1/2 that dose (0.5mg BID) for those subjects that weigh less than or equal to 55kg at baseline, for twelve weeks, follow-up through Week 52; Oral Varenicline 0.5mg BID, or 1/2 that dose (0.5 QD) for those subjects that weigh less than or equal to 55kg at baseline, for twelve weeks, follow-up through Week 52; Oral placebo for twelve weeks,follow-up through Week 52
Intervention MeSH terms: Varenicline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 312.0
Sex: All
Minimum age: 12 Years
Maximum age: 19 Years
Healthy volunteers: No
Keywords: smoking cessation in adolescents

Summary:

      The study is designed to see if varenicline combined with age appropriate (adolescent)
      smoking cessation counseling will help teens quit smoking.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and female subjects between the ages of 12 and 19, inclusive.

          -  Subjects smoking at least an average of 5 cigarettes per day, motivated to stop
             smoking,

          -  Subjects must have at least one prior failed attempt to quit smoking.

        Exclusion Criteria:

          -  Subjects with history, current diagnosis, or treatment of major depression disorder,
             anxiety disorders, panic disorder, hostility or aggression disorder,
             perceptual/thinking disturbances, mania, psychosis, bipolar disorder, personality
             disorder, eating disorder or severe emotional problems (in the past year).

          -  Subjects with a prior suicide attempt: subjects hospitalized within the past 12 months
             due to suicidal ideation or suicidal behavior; subjects considered to have serious
             suicidal ideation or suicidal behavior in the past 12 months; active suicidal ideation
             or behavior identified at the screening or baseline visit.

          -  Evidence of alcohol and substance abuse/dependence (other than nicotine) within 3
             months prior to screening.
Brinzolamide/Brimonidine Combination vs Brimonidine 0.2% in the Prevention of IOP Rise After Nd-YAG Laser Capsulotomy
Condition: Posterior Capsule Opacification; Ocular Hypertension
MeSH terms: Ocular Hypertension; Capsule Opacification; Hypertension
Intervention: Brinzolamide/Brimonidine FC; Brimonidine 0.2%; Artificial tears
Intervention description: 1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy; 1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy; 1 drop of artificial tears 1 hour before Nd-YAG capsulotomy
Intervention MeSH terms: Brimonidine Tartrate; Lubricant Eye Drops; Dipivefrin; Brinzolamide
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a prospective, randomized, double masked comparative study
Masking: Double (Participant, Investigator)
Masking description: Patients are masked to their assignment by covering the labels on the bottles of the drugs administered The investigator responsible for the measurement of the intraocular pressure is also masked to the intervention administered to each patient.
Enrollment: 79.0
Sex: All
Healthy volunteers: No
Keywords: Nd-YAG capsulotomy; ocular hypertension; brimonidine; brinzolamide

Summary:

      To compare the efficacy of a Brinzolamide/Brimonidine fixed combination (FC) with Brimonidine
      0.2% in preventing intraocular pressure (IOP) elevations after neodymium:
      yttrium-aluminum-garnet (Nd:YAG) laser posterior capsulotomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients scheduled to undergo laser posterior capsulotomy due to posterior capsule
             opacification (PCO) after uneventful phacoemulsification cataract extraction with
             implantation of posterior chamber intraocular lenses (IOL/PC).

        Exclusion Criteria:

          -  baseline IOP greater than 21mmHg

          -  glaucomatous eyes, already under treatment with anti glaucomatic medications

          -  intraocular surgery except for uncomplicated cataract surgery

          -  previous photorefractive surgery

          -  active ocular inflammation or infection

          -  patients under systemic administration of medications known to affect IOP

          -  patients with severe respiratory or cardiovascular disease

          -  pregnant or breast feeding women, and individuals with known hypersensitivity or
             contraindication for administration of the medications tested

          -  a measurement of IOP > 30 mmHg at any time point of the study, or an increase from
             baseline >20 mmHg
Fascia Iliaca Blocks for Pain Control After Total Hip Arthroplasty
Condition: Arthritis of Hip
MeSH terms: Arthritis
Intervention: Fascia iliaca compartment block; Placebo; Bupivacaine
Intervention description: The patient will be brought to the block room within 30 minutes of arriving in recovery. An injection of local anesthetic into the fascia iliaca compartment using ultrasound guidance will be administered. The patient will then be transported back to recovery.; The patient will be brought to the block room within 30 minutes of arriving in recovery. An ultrasound probe will be placed to the skin and a blunt needle will be touched to the patient's skin in the area that a fascia iliaca compartment block would be performed. The patient will then be transported back to recovery.; A one time dose of 40 milliliters of 0.5% bupivacaine will be injected into the fascia iliaca compartment
Intervention MeSH terms: Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: The patients will be randomized to receive fascia iliaca blocks post-operatively or to receive a touch with a blunt needle and a bandaid post-operatively by the regional anesthesia team. Neither the patient nor the investigators will have knowledge of which group the patients belong to until the completion of the data collection.
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Total Hip Arthroplasty; Fascia Iliaca; Nerve Block; Pain Control

Summary:

      The fascia iliaca compartment block (FICB) is a regional block that anesthetizes the femoral,
      obturator, and lateral femoral cutaneous nerves around the hip. The purpose of this study is
      to determine whether FICB can reduce postoperative pain and increase progress with physical
      therapy after total hip arthroplasty (THA). This randomized, double-blind, clinical trial
      will randomize patients to receive either a FICB or placebo after THA. The primary outcomes
      will be pain scores reported by the patient post-operatively.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients over the age of 18

          -  Scheduled for total hip arthroplasty at Henry Ford Hospital

          -  Epidural anesthesia during surgery

        Exclusion Criteria:

          -  Pregnancy

          -  Known intolerance to local anesthetic or narcotics

          -  Revision hip surgery
Open-Label Non-Inferiority Study Evaluating the Efficacy and Safety of Xeomin® in Subjects With Cervical Dystonia Flex
Condition: Cervical Dystonia
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Intervention: Xeomin®
Intervention description: Xeomin is botulinum toxin type A produced from fermentation of Hall strain Clostridium botulinum serotype A
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 283.0
Sex: All
Minimum age: 18 Years
Maximum age: 81 Years
Healthy volunteers: No

Summary:

      This study will compare Xeomin®, a botulinum toxin medication, in shorter treatment intervals
      (Short Flex dosing) to the standard interval dosing (Long Flex dosing) to determine if the
      response to treatment is comparable in both how it works and any side effects. Xeomin® is
      approved by the United States Food and Drug Administration (FDA) for the treatment of
      cervical dystonia (CD). The use of Xeomin® is investigational in regards to shorter treatment
      intervals. An investigational use is one that is not approved by the FDA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented clinical diagnosis of idiopathic or genetic Cervical Dystonia

        Exclusion Criteria:

          -  Current treatment with botulinum toxin of any type for any other indication (including
             aesthetic indications) and for any body region during the study.
Compare the Efficacy and Safety of Raltegravir Versus Efavirenz Combination Therapy in Treatment-naïve HIV-1 Patients
Condition: HIV-1 Infection
MeSH terms: Infections
Intervention: Raltegravir; Efavirenz
Intervention description: Raltegravir 400mg oral twice daily; Efavirenz 600mg oral at bedtime
Intervention MeSH terms: Efavirenz; Raltegravir Potassium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 107.0
Sex: All
Minimum age: 20 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Efavirenz; Raltegravir; Combination antiretroviral therapy

Summary:

      A pilot study to compare the efficacy and safety of raltegravir-based versus efavirenz-based
      combination therapy in treatment-naïve patients with HIV-1 infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who are infected with HIV-1

          -  Patients have not yet received any treatment for HIV

          -  Patients with HIV viral RNA exceeds 5000 copies per ml

          -  Ages at least 20 years

        Exclusion Criteria:

          -  Patients with acute or decompensated chronic hepatitis

          -  Patients with chronic hepatitis and serum aminotransferase concentrations are more
             than five times the upper limit of the normal range

          -  Patients with renal insufficiency (need dialysis or have serum creatinine
             concentrations of more than twice the upper limit of the normal range

          -  Patients with any medical disorder that the use of study medications is
             contraindicated

          -  Pregnant or breastfeeding women

          -  Patients who are lack of expectation to maintain assigned study medication during
             study period

          -  Patients who have received therapy with investigational drugs in the previous 3 months
Patient Satisfaction With Propofol for Out Patient Colonoscopy
Condition: Colon Cancer; IBS; Polyps
MeSH terms: Colonic Neoplasms
Intervention: Propofol; Fentanyl Plus Midazolam
Intervention description: The intervention is to use propofol as anesthesia during a colonoscopy.; The control is to use standard of care anesthesia, fentanyl and midazolam, during a colonoscopy.
Intervention MeSH terms: Midazolam; Fentanyl; Propofol
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 600.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: propofol; colonoscopy; patient satisfaction

Summary:

      The primary purpose of this study is to determine if patient satisfaction with propofol is
      better than with non-propofol anesthesia for outpatient colonoscopies.
    

Eligibility criteria:

        Inclusion Criteria:

        - Patients having an outpatient colonoscopy

        Exclusion Criteria:

        - High risk patients (ASA IV & V) who are not candidates for colonoscopy in an outpatient
        center will be excluded.
Desipramine in Infantile Neuroaxonal Dystrophy (INAD).
Condition: Infantile Neuroaxonal Dystrophy
MeSH terms: Neuroaxonal Dystrophies
Intervention: Desipramine
Intervention description: Study drug (desipramine) provided in tablet form to be taken daily.
Intervention MeSH terms: Desipramine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Pediatric genetic disorder; cognitive function; neuro-muscular disorder; PLA2G6

Summary:

      This is a research study to find out if clinically prescribed desipramine is effective at
      improving the symptoms and slowing the progression of Infantile Neuroaxonal Dystrophy (INAD)
      in affected children.

      Participants will receive an initial oral dose of study drug once a day. This dose may be
      changed depending on response to study drug Clinically collected data will be recorded for up
      to 5 years. Investigators will also ask for participant permission to obtain a sample of
      child's skin biopsy from unused clinical sample previously collected for standard of care.
    

Eligibility criteria:

        Inclusion Criteria:

          -  03-17years.

          -  Any gender

          -  Confirmed homozygotes or compound heterozygotes of pathogenic mutation variant(s) in
             PLA2G6

          -  Confirmed homozygotes of pathogenic mutation in PLA2G6

          -  Documentation of clinical presentation (signs and symptoms of neurodegenerative
             process) of INAD

        Exclusion Criteria:

          -  Patient has sign and symptom suggesting an ongoing acute or chronic illness such as
             fever of unknown origin or infection.

          -  Patient has a second genetic condition

          -  Parents are unable or unwilling to return for continued care for up to 12 months
High vs Low Dose Dexamethasone on Complications in the Immediate Postoperative Phase
Condition: Hip Dysplasia; Postoperative Complications
MeSH terms: Hip Dislocation; Developmental Dysplasia of the Hip; Hip Dislocation, Congenital; Postoperative Complications
Intervention: Dexamethasone
Intervention description: intravenous
Intervention MeSH terms: Dexamethasone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The aim of this study is to investigate the effect of a single preoperative high-dose steroid
      injection on complications in the immediate postoperative phase after periacetabular
      osteotomy. Primary outcome is the proportion of patients who have moderate to severe
      postoperative pain in the post anaesthesia care unit. Secondary outcomes are organspecific
      complications in the post anaesthesia phase, pain and nausea the first 5 days, wound
      infection and readmissions the first 30 days after surgery.

      The investigators hypothesize that the frequency of moderate to severe pain and organspecific
      complications in the post anaesthesia care unit will be lower among patients receiving high
      dose dexamethasone. The investigators hypothesize, that there will be no difference in wound
      infections or readmissions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  planned unilateral periacetabular osteotomy

          -  informed signed consent

        Exclusion Criteria:

          -  Chronic/ongoing (<30 days) use of glucocorticoids (except inhalation therapy)

          -  ongoing (<30 days) use of immunosuppressive therapy

          -  insulin dependent diabetes

          -  pregnancy/breastfeeding

          -  allergies toward study medication, or medication in the standard treatment

          -  surgery cannot be performed