bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of Fluoxetine in Young People for the Treatment of Major Depression and Marijuana Dependence
Condition: Depressive Disorder, Major; Cannabis Abuse
MeSH terms: Marijuana Abuse; Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Fluoxetine; Placebo
Intervention description: Gelatin capsules Fluoxetine 10 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of fluoxetine 20 mg, 2 capsules barring side effects.; Gelatin capsules Placebo capsules, identical to Fluoxetine capsules, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of placebo, 2 capsules barring side effects.
Intervention MeSH terms: Fluoxetine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 70.0
Sex: All
Minimum age: 14 Years
Maximum age: 25 Years
Healthy volunteers: No
Keywords: Cannabis; MDD

Summary:

      Adolescents who are diagnosed with major depressive disorder are often also diagnosed with
      marijuana dependence. Fluoxetine is an antidepressant medication currently used to treat
      young people who are diagnosed with major depressive disorder. The purpose of this study is
      to determine the effectiveness of fluoxetine in treating adolescents and young adults
      diagnosed with both major depressive disorder and marijuana dependence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  DSM-IV diagnosis of current marijuana abuse or dependence, confirmed by SCID-SUD

          -  DSM-IV diagnosis of current major depressive disorder, confirmed by the K-SADS

          -  Marijuana use of at least two days within the week prior to enrollment

          -  Demonstrated adequate levels of depressive symptoms within the week prior to
             enrollment

        Exclusion Criteria:

          -  DSM-IV diagnosis of bipolar disorder, schizoaffective disorder, or schizophrenia

          -  Hypo or hyperthyroidism

          -  Significant cardiac, neurological, or kidney impairment

          -  Liver disease (SGOT, SGPT, or gamma-GTP greater than 3 times the normal level)

          -  Use of antipsychotic or antidepressant medication in the month prior to enrollment

          -  DSM-IV dependence on any substance except marijuana or nicotine; alcohol dependence,
             or history of drug use

          -  History of significant medication side effects from any SSRI antidepressant

          -  Pregnant

          -  Unable to use adequate contraceptive methods for the duration of the study

          -  Inability to read or understand English
Arginine Therapy for Sickle Cell Disease Pain
Condition: Sickle Cell Disease; Vaso-occlusive Pain Episode
MeSH terms: Anemia, Sickle Cell
Intervention: L-arginine; L-arginine Loading Dose; Placebo
Intervention description: L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.; One loading dose of L-arginine will be dispensed intravenously (IV) at 200 mg/kg; Placebo of intravenous (IV) normal saline 1-2 ml/kg three times a day until discharge from the emergency department (ED) or hospital.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 108.0
Sex: All
Minimum age: 3 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Arginine Therapy

Summary:

      The aim of this study is to determine whether giving extra arginine, a simple amino acid, to
      patients with sickle cell disease seeking treatment for a pain crisis (vaso-occlusive painful
      events (VOE) will decrease pain scores, decrease the need for pain medications or decrease
      length of hospital stay or emergency department visit. Funding Source - FDA OOPD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Established diagnosis of sickle cell disease (SCD); all genotypes

          -  Pain requiring medical care in an acute care setting (such as the emergency department
             or ED, hospital ward, day hospital, clinic) not attributable to non-sickle cell
             causes, that is moderate-to-severe requiring parenteral opioids

        Exclusion Criteria:

          -  Decision to discharge home from the acute care setting

          -  Hemoglobin less than 5 gm/dL or immediate need for red cell transfusion anticipated
             within next 12 hours

          -  Hepatic dysfunction of SGPT greater than 3 times the upper value

          -  Renal dysfunction of creatinine greater than 1.0

          -  Mental status or neurological changes

          -  Acute stroke or clinical concern for stroke

          -  Pregnancy

          -  Allergy to arginine

          -  Two (2) or more ED visits for VOE within the last 7 days prior to CURRENT ED visit

          -  Hospitalization within 14 days

          -  Previous randomization in this arginine RCT (patient consented and screen failed
             before receiving study drug or placebo remains eligible for future participation).

          -  Use of inhaled nitric oxide, sildenafil or arginine within the last month

          -  PICU admission from the emergency department

          -  Hypotension requiring treatment with clinical intervention

          -  Acidosis with Co2≤ 16

          -  Newly started on HU for <3 months

          -  Not an appropriate candidate in the investigator's judgment

          -  Patient refusal
Fish Oil to Reduce Tobacco Use iN Expectant Mothers Study
Condition: Tobacco Use in Childbirth; Smoking Cessation; Pregnancy Related
Intervention: Fish oil; Placebos
Intervention description: Fish oil supplementation; Olive Oil capsules
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blinded, placebo controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-blind, placebo control with medications dispensed by the Investigational Drug Service
Enrollment: 28.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: n-3 polyunsaturated fatty acids; tobacco use; pregnancy

Summary:

      The purpose of this feasibility study is to obtain pilot data in preparation for an upcoming
      R01 submission. The goals of that submission will be to conduct a clinical trial of n-3
      LCPUFAs for smoking cessation in pregnant women. For this proposal, the investigators will
      develop, test, and refine the recruitment strategy and collect data demonstrating the
      investigators ability to successfully recruit pregnant women who are actively smoking. The
      investigators will collect side effect, tolerability, and adherence data regarding the
      intervention. Finally, the investigators hope to gather preliminary effect size data to allow
      more formal estimates of sample size. The investigators hypothesize that pregnant smokers
      randomized to n-3 LCPUFA supplementation will have higher smoking cessation rates and less
      nicotine cravings compared to women allocated to placebo. The investigators intend to use
      this preliminary data to inform a future randomized, double-blind, placebo-controlled trial
      of n-3 LCPUFA supplementation for tobacco cessation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥ 18 or ≤ 45 years of age

          -  Currently reporting daily cigarette use (≥ 1 CPD, no averages, must have daily use)

          -  Between 6 and 36 weeks gestation

        Exclusion Criteria:

          -  Allergy to fish or seafood

          -  Currently using fish oil supplements and unwilling to stop prior to and during the
             trial

          -  Unstable psychiatric disease: Defined as requiring hospitalization or active
             medication changes (medication changes or up titration) within the preceding 3 months

          -  Unstable pregnancy-related medical problems (pre-eclampsia, premature labor,
             threatened abortion, oligohydramnios, placenta previa, hyperemesis gravidarum, HELLP
             syndrome, Intrauterine growth restriction, cholestasis of pregnancy, Rh negative
             disease, gestational hypertension, placenta accreta)
Open-label Extension Study to Assess Safety and Tolerability of LYC-30937-EC in Subjects With Active Ulcerative Colitis
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: LYC-30937-EC
Intervention description: LYC-30937-EC 25 mg by mouth once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 112.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to allow subjects completing study LYC-30937-2001 the
      opportunity to receive LYC-30937-EC 25 mg.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed the 8-week double-blind treatment period of study LYC-30937-2001

          -  Male and females of childbearing potential must agree to use adequate birth control
             during the study and for 30 days after discontinuing study drug

          -  Non-pregnant, non-lactating females who are not planning to become pregnant while
             enrolled in this study

          -  Investigator considers it safe and potentially beneficial to participate

          -  Ability to provide written informed consent and to be compliant with study schedule

        Exclusion Criteria:

          -  Subjects who completed study LYC-30937-2001, but who experienced a serious adverse
             event that was considered related to investigational product, has an unstable medical
             condition, or for any other reason in the opinion of the investigator should not
             participate in this study
EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)
Condition: Edematous Fibrosclerotic Panniculopathy; Cellulite
MeSH terms: Cellulite; Edema
Intervention: Collagenase Clostridium Histolyticum
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 259.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A Phase 2, Open-Label Extension Study of EN3835 in the Treatment of Edematous Fibrosclerotic
      Panniculopathy (commonly known as Cellulite).
    

Eligibility criteria:

        Inclusion Criteria for Observation Phase:

          -  Voluntarily sign and date an informed consent agreement

          -  Have participated in and completed the double-blind study EN3835-201

          -  Be willing to apply sunscreen to any treated quadrant before each exposure to sun

        Inclusion Criteria for Treatment Phase:

          -  Voluntarily sign and date an informed consent agreement

          -  Have participated in and completed the double-blind study EN3835-201

          -  Be willing to apply sunscreen to any treated quadrant before each exposure to sun

          -  Have at least 1 quadrant with: a score of 3 or 4 (moderate or severe) as reported on
             the PCSS (Photonumeric Cellulite Severity Scale) by the subject or investigator, and a
             Hexsel CSS (Cellulite Severity Scale) score no greater than 13

          -  Be judged to be in good health

          -  Have a negative urine pregnancy test at screening and be using an effective
             contraception method, be surgically sterile, or post-menopausal

        Exclusion Criteria for Observation Phase:

          -  None

        Exclusion Criteria for Treatment Phase:

          -  Has used, or intends to use during the course of the study, other treatment of EFP on
             the legs or buttocks

          -  Is presently nursing a baby or providing breast milk for a baby

          -  Intends to become pregnant during the study

          -  Currently receiving, has received within 7 days before injection of study drug, or
             plans to receive an anticoagulant or antiplatelet medication

          -  History of stroke or bleeding
The Effect of Caffeine on Postextubation Adverse Respiratory Events in Children With Obstructive Sleep Apnea (OSA).
Condition: Sleep Apnea, Obstructive; Tonsillectomy; Adenoidectomy; Postoperative Complications
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Postoperative Complications
Intervention: Caffeine; Placebo
Intervention description: Children in group one will receive caffeine benzoate 20 mg/kg i.v., which is equal to a 10 mg/kg caffeine base.; Children in group two will receive an amount of normal saline equal to Caffeine
Intervention MeSH terms: Caffeine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 74.0
Sex: All
Minimum age: 30 Months
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Obstructive Sleep Apnea (OSA); Tonsillectomy and Adenoidectomy (T&A); Postoperative Complications; Recovery

Summary:

      This is a research study using caffeine in children who have an obstructive sleep apnea
      (OSA). OSA means children who stop breathing during their sleep due to obstruction in their
      airway. The purpose of this study is to determine whether caffeine when given in the vein,
      will wake children up faster and decrease post-anesthesia airway obstruction, as well as the
      safety and if the drug agrees with the child compared to a placebo (an inactive or dummy
      agent).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children between 2.5-18 years old

          -  Diagnosed with obstructive sleep apnea

          -  Undergoing elective tonsillectomy and adenoidectomy

        Exclusion Criteria:

          -  Age below 2.5 or above 18 years
Safety and Efficacy Study on the Implantation of the Tension-Free Vaginal Tape (TVT-Secur) Under Local Anesthesia
Condition: Urinary Stress Incontinence
MeSH terms: Urinary Incontinence, Stress
Intervention: TVT-SECUR - 'Hammock' technique; TVT-SECUR - 'U-Method'; Local anesthesia (30 to 40 ml of a mixture of 35 ml of lidocaine 2% and 5 ml of bicarbonate 3%).
Intervention description: The surgery was done under local anesthesia by one high-volume surgeon. The 'Hammock' technique, similar to the transobturator tape dissection, was used in the first 23 cases and the 'U-Method', similar to the retropubic tape dissection, in the last 25 cases. Interim analysis performed after 23 cases led us to change the technique to the 'U-Method'.; The surgery was done under local anesthesia by one high-volume surgeon. The 'Hammock' technique, similar to the transobturator tape dissection, was used in the first 23 cases and the 'U-Method', similar to the retropubic tape dissection, in the last 25 cases. Interim analysis performed after 23 cases led us to change the technique to the 'U-Method'.; Local anesthesia consisted of 30 to 40 ml of a mixture of 35 ml of lidocaine 2% and 5 ml of bicarbonate 3%. Sedation was used in association with local anesthesia, including 1 mg of lorazepam sublingual as well as a combination of 0.5 to 2 mg intravenous (IV) of midazolam and 50 to 200 ug IV of fentanyl. Postoperative analgesia consisted of a prescription of 30 tablets of morphine 5 mg.
Intervention MeSH terms: Lidocaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: Female
Healthy volunteers: No
Keywords: Suburethral slings; Urethra; Urinary incontinence; Urinary stress incontinence

Summary:

      The objective was to observe the satisfaction of local anesthesia during the implantation of
      the TVT-SECUR for the treatment of stress urinary incontinence, with the use of
      questionnaires completed by the patients, and to evaluate the short-term efficacy and safety
      of the sling, with a comparison of the two techniques of implantation: the 'U-Method' and the
      'Hammock' technique.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of stress urinary incontinence or stress predominant mixed urinary
             incontinence

          -  Acceptance of local anesthesia
Abdominal Binder to Treat Orthostatic Hypotension (OH) in Parkinson's Disease (PD)
Condition: Parkinson's Disease; Neurogenic Orthostatic Hypotension in Parkinson's Disease
MeSH terms: Parkinson Disease; Hypotension, Orthostatic; Hypotension
Intervention: Elastic abdominal binder; Placebo binder
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: N/A (the Intervention type in the present study was an elastic abdominal binder, which is a medical device)
Masking: Single (Participant)
Enrollment: 15.0
Sex: All
Minimum age: 40 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      The purpose of the present study is to determine whether the use of an abdominal binder is
      effective in the non-pharmacological management of orthostatic hypotension in patients
      suffering from Parkinson's disease
    

Eligibility criteria:

        Inclusion Criteria:

          -  Idiopathic PD

          -  Hoehn & Yahr stadium < or = 4

          -  Age: 40-90

          -  Laboratory confirmed neurogenic orthostatic hypotension (NOH)

          -  Stable pharmacological therapy in the last 6 weeks

          -  Full legal competence

        Exclusion Criteria:

          -  Other major neurologic or psychiatric diseases

          -  Untreated diabetes mellitus with clinical features of peripheral neuropathy

          -  Major cardiac diseases (ischemic, structural, arrhythmias)

          -  Evidence of varices (venous insufficiency stage > or = C2, "varicose veins")

          -  Known or suspected pregnancy

          -  Breast feeding
Efficacy and Safety of AUT00063 Versus Placebo in Age-Related Hearing Loss
Condition: Age-Related Hearing Loss
MeSH terms: Hearing Loss; Deafness; Presbycusis
Intervention: AUT00063; Placebo
Intervention description: 600 mg, orally, once a day, for 4 weeks; orally, once a day, for 4 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 78.0
Sex: All
Minimum age: 50 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: hearing loss; speech-in-noise

Summary:

      This study aims to demonstrate that the investigational drug AUT00063 is effective and safe
      in the treatment of age-related hearing loss.
    

Eligibility criteria:

        -  Be between ages 50-89 years old

          -  American-English speaking

          -  Have difficulty hearing speech in a noisy environment

          -  No recent history of middle ear disease

          -  No severe insomnia, major depressive disorders, severe anxiety or post-traumatic
             stress disorder

          -  Not a current or previous user of hearing aids. You are eligible if you were
             noncompliant and stopped wearing a hearing aid device >6 months earlier for
             intermittent use or >3 years if you were a full-time consistent user of hearing aid
             devices

          -  Not be dependent on alcohol or drugs

          -  Have not participated in another research study within 30-days

          -  If female, you must confirm to be non child bearing (post-menopausal for at least
             12-months or surgically sterile)

          -  If male, you must confirm to use a barrier method (condom)

          -  Not be a professional musician

          -  No history of important cardiac, endocrine, pulmonary, neurologic, psychiatric,
             hepatic, renal, hematologic, immunologic, or other major disease deemed clinically
             significant by the study doctor

        While you are in the study, you must:

          -  Follow the instructions you are given

          -  Come to the study centre for all visits with the study doctor or study staff

          -  Answer the telephone at the scheduled date and time for the 2 telephone calls

          -  Tell the study doctor or study staff about any changes in your health or the way you
             feel

          -  Tell the study doctor or study staff if you want to stop being in the study at any
             time

          -  Bring your Diary to each visit

          -  Not eat or drink anything containing Grapefruit beginning 7-days before Baseline visit
             (Visit 3, Day 1) until the end of the study

          -  Use sun screen if you plan to sunbathe

          -  Not use headphones or headsets at high volume

          -  Not use hearing aids or devices at any time during the study
A Study of Herceptin (Trastuzumab)and Biomarkers in Patients With HER2-Positive Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Standard taxane therapy; capecitabine [Xeloda]; trastuzumab [Herceptin]
Intervention description: As prescribed; 1000mg/m2 po bid on days 1-14 of each 3-week cycle (only in patients who have progressed); 8mg/kg iv loading dose on day 1 of first 3-week cycle, and 6mg/kg iv on day 1 of each subsequent cycle
Intervention MeSH terms: Capecitabine; Trastuzumab; Taxane
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study will evaluate alterations in molecular marker expression in
      HER2-positive targeted therapy, and will evaluate the effect of continued treatment with
      Herceptin and Xeloda beyond progression following initial Herceptin-taxane chemotherapy.
      Patients who develop progressive disease will receive first-line Herceptin (8mg/kg iv loading
      dose and 6mg/kg iv every 3 weeks) + taxane therapy. patients who develop progressive disease
      within 9 weeks of treatment will continue treatment with Herceptin in combination with Xeloda
      (1000mg/m2 po bid on days 1-14 of each 3-week cycle).Biopsies of tumor tissue will be taken
      for biomarker and gene profiling evaluation. The anticipated time on study treatment is until
      disease progression, intolerable side effects or patient choice, and the target sample size
      is 100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  female patients, >=18 years of age;

          -  HER2-positive breast cancer;

          -  al least one metastatic site amenable for core biopsy;

          -  left ventricular ejection fraction >50%.

        Exclusion Criteria:

          -  prior adjuvant/neoadjuvant Herceptin within past 6 months;

          -  prior adjuvant taxane therapy within past 12 months;

          -  use of chemotherapy, immunotherapy or biological anticancer therapy within past 3
             weeks;

          -  known bleeding diatheses.