bioihbjkbjnl/mcl2 huggingface dataset:
Double-Blind Naltrexone in Kleptomania
Condition: Kleptomania
MeSH terms: Disruptive, Impulse Control, and Conduct Disorders
Intervention: Naltrexone; Placebo
Intervention description: daily; daily
Intervention MeSH terms: Naltrexone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 25.0
Sex: All
Minimum age: 21 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Compulsive Shoplifting; Kleptomania; Compulsive Stealing

Summary:

      The goal of the proposed study is to evaluate the efficacy and safety of naltrexone in
      kleptomania.
    

Eligibility criteria:

        Inclusion Criteria:

          1. men and women age 21-75

          2. current DSM-IV kleptomania.

        Exclusion Criteria:

          1. unstable medical illness or clinically significant abnormalities on prestudy
             laboratory tests or physical examination

          2. history of seizures

          3. myocardial infarction within 6 months

          4. current pregnancy or lactation, or inadequate contraception in women of childbearing
             potential

          5. clinically significant suicidality

          6. current or recent (past 3 months) DSM-IV substance abuse or dependence

          7. illegal substance within 2 weeks of study initiation

          8. initiation of psychotherapy or behavior therapy from a mental health professional for
             the treatment of kleptomania within 3 months prior to study baseline

          9. initiation of a psychotropic medication within 2 months prior to study inclusion

         10. previous treatment with naltrexone

         11. treatment with investigational medication or depot neuroleptics within 3 months, with
             fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study
             baseline.
Nocturnal/Diurnal Intraocular Pressure-Lowering Effect of Netarsudil Ophthalmic Solution
Condition: Ocular Hypertension; Open Angle Glaucoma
MeSH terms: Glaucoma, Open-Angle; Ocular Hypertension
Intervention: Netarsudil ophthalmic solution 0.02%; Netarsudil Ophthalmic Solution Vehicle
Intervention description: Once daily in both eyes (OU) in the evening (PM) for 7 days; Once daily in both eyes (OU) in the evening (PM) for 7 days
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate effect of Netarsudil Ophthalmic Solution 0.02% on Nocturnal and Diurnal
      Intraocular Pressure.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18 years of age or older.

          2. Ocular hypertension or open-angle glaucoma in both eyes.

          3. Unmedicated intraocular pressure > 17 mmHg in one or both eyes and < 30 mmHg in both
             eyes.

          4. Corrected visual acuity in each eye equivalent to 20/200 or better.

          5. Able and willing to give signed informed consent and follow study instructions.

        Exclusion Criteria:

          1. Glaucoma with pseudoexfoliation or pigment dispersion component, history of angle
             closure, narrow angles.

          2. Intraocular pressure ≥ 30 mmHg.

          3. Use of ocular medications within 30 days.

          4. Known hypersensitivity to any component of the test formulations or to medications
             used routinely during a clinical eye examination.

          5. Previous eye surgery (other than cataract).

          6. Ocular trauma within 6 months.

          7. Clinically significant ocular disease that might interfere with the study.

          8. Central corneal thickness greater than 620 µm.
Measuring Ambulation, Motor, and Behavioral Outcomes With Post-Stroke Fluoxetine in Tanzania
Condition: Acute Stroke; Stroke, Ischemic
MeSH terms: Stroke; Ischemic Stroke
Intervention: Fluoxetine 20 MG Oral Tablet
Intervention description: Once-daily dosing for 90 days
Intervention MeSH terms: Fluoxetine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Phase II study of one dose
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Motor recovery

Summary:

      This is a phase II, randomized study of 120 adults age 18 or above who will prescribed 20mg
      daily Fluoxetine for 90 days following acute, ischemic stroke.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participant is 18 years of age or older

          2. Participant has experienced a CT-confirmed ischemic stroke w/in 21 days of enrollment

        Exclusion Criteria:

          1. NIH Stroke Scale Score >20 points

          2. Unconscious at presentation

          3. Hemorrhagic conversion of ischemic infarct

          4. transient ischemic symptoms <24h,

          5. Current antidepressant or psychoactive drug use (e.g. SSRI, monoxidase amine
             inhibitor, benzodiazepine).

          6. Current pregnancy.

          7. History of recent head trauma.

          8. Baseline motor deficits from other etiologies including prior stroke.

          9. Dysphagia preventing the swallowing of a pill.

         10. Hyponatremia (<125 mmol/L), hepatic impairment as defined by a serum alanine
             aminotransferase (ALT) of >120 U/L.

         11. Renal impairment as defined by a creatinine >180 micromol/L or GFR <30mL/min/1.73m2.

         12. Patients who are moribund for other reasons and unlikely to survive to 90 days will
             also be excluded from participation.

         13. Contraindication to MRI (e.g. piercings/tattoos, electronic/metallic implants,
             claustrophobia)

         14. Contraindication to lumbar puncture (e.g. infection at site of needle insertion,
             evidence of elevated ICP, coagulopathy/thrombocytopenia or use of therapeutic
             anticoagulation, or a history of LP complications).
Dosage Schedule Study of Pemetrexed Monochemotherapy for Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Pemetrexed - Before Protocol Amendment; Pemetrexed - After Protocol Amendment
Intervention description: 500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles or disease progression, unacceptable toxicity or patient decision to discontinue; 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 6 cycles or disease progression, unacceptable toxicity or patient decision to discontinue.
Intervention MeSH terms: Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Patients affected by non-small cell lung cancer (NSCLC) will be treated in pemetrexed
      monochemotherapy regimen for a maximum of 8 cycles. Pemetrexed is an enhancer of some
      biomolecules involved in the gemcitabine mechanism of action. Purpose of the trial is to
      monitor the blood values of these biomolecules at different time intervals, to optimize the
      synergism between pemetrexed and gemcitabine.
    

Eligibility criteria:

        Inclusion Criteria

          -  Histologically or cytologically proven IIIB and IV NSCLC.

          -  No symptomatic uncontrolled brain metastasis

          -  Not suitable for platinum containing regimens if chemo-naive

          -  Performance status less than or equal to 2 on the Eastern Cooperative Oncology Group
             (ECOG) Scale.

          -  Creatinine Clearance (CrCl) greater than or equal to 45 milliliters per min (mL/min)

        Exclusion Criteria

          -  Prior radiation to greater than 25% of bone marrow

          -  Inability to interrupt Aspirin at doses of greater than 1.3 grams/day or non-steroidal
             anti-inflammatory agents for a 5-day period.

          -  Presence of clinically relevant third-space fluid collections not controllable.

          -  Significant cardiac disease
Homeopathic Treatment for Depression in Peri- and Postmenopausal Women
Condition: Moderate Depression; Menopausal and Postmenopausal Disorders
MeSH terms: Depression; Depressive Disorder
Intervention: Individualized homeopathic treatment; Fluoxetine; Placebo
Intervention description: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms.; 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4.; Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4.
Intervention MeSH terms: Fluoxetine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 133.0
Sex: Female
Minimum age: 40 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Depression; Perimenopause; Postmenopause; Homeopathy

Summary:

      The aim of this study was to determine whether individualized homeopathic treatment and
      fluoxetine are more efficient than placebo for moderate to severe depression in peri- and
      postmenopausal women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Major depression according to DSM-IV

          -  Moderate to severe depression according to 17-item Hamilton Rating Scale for
             Depression (14-24 score)

          -  No current use of homeopathic treatment for depression or antidepressants or
             anxiolytic drugs 3 months prior to study entry

          -  Not be currently taking psychotherapy for at least 3 months before study entry

          -  Early transition to menopause defined by a change in cycle length of 7 days or longer
             in either direction from the participant´s own baseline for at least 2 cycles

          -  Late transition to menopause defined as 3 to 11 months of amenorrhea

          -  Postmenopausal stage defined by 12 months or more of amenorrhea

          -  Capability and willingness to give informed consent and to comply with the study
             procedures

        Exclusion Criteria:

          -  Pregnancy or breastfeeding

          -  Other psychiatric disorders different from moderate to severe depression (severe
             depression, schizophrenia, psychotic disorders, bipolar affective disorders, suicide
             attempt)

          -  Alcohol or other substance abuse

          -  Known allergy to fluoxetine

          -  Cancer or hepatic diseases
Study of Antidepressant Efficacy of a Selective, High Affinity Enkephalinergic Agonist in Anxious Major Depressive Disorder (AMDD)
Condition: Anxious Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: AZD2327; Placebo
Intervention description: Tablet, Oral, Daily; Tablet, Oral, Daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Anxious Major Depressive Disorder

Summary:

      This study will determine if a highly selective enkephalinergic receptor modulator is
      effective in the treatment of anxious major depressive disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of informed consent prior to any study specific procedures

          -  Diagnosis of major depressive disorder without psychotic features (MDD)

        Exclusion Criteria:

          -  A history of substance or alcohol abuse within the past 6 months or dependence within
             1 year of enrollment as defined by DSM-IV criteria.

          -  Women that are pregnant or lactating

          -  History of pancreatitis
PF-06372865 in Subjects With Photosensitive Epilepsy
Condition: Reflex Epilepsy, Photosensitive
MeSH terms: Epilepsy; Epilepsy, Reflex
Intervention: PF-06372865; Placebo; Lorazepam
Intervention description: Single dose; Placebo for PF-06372865 and placebo for lorazepam; 2 mg single oral dose
Intervention MeSH terms: Lorazepam; PF-06372865
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      PF-06372865 in subjects with photosensitive epilepsy
    

Eligibility criteria:

        Inclusion Criteria:

          -  A diagnosis and history of photoparoxysmal response on electroencephalogram (EEG) with
             or without a diagnosis of epilepsy for which subjects are taking up to 0 - 2
             concomitant antiepileptic drugs.

          -  Subjects currently taking antiepileptic drug(s) to be on a stable dose for 4 weeks
             prior to Screening Visit.

          -  A minimum average standardized photosensitive range (SPR) across all screening
             timepoints of 4 in the most sensitive eye condition and a non-zero average in at least
             one other eye condition.

        Exclusion Criteria:

          -  Subjects with a history of status epilepticus.

          -  Subjects who have experienced a generalized tonic-clonic convulsion in the past 6
             months, at the time of the initial screening visit.
Rollover Protocol Continued Access to Emtricitabine/Tenofovir Disoproxil Fumarate for Adults in United States
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: FTC/TDF
Intervention description: 200/300 mg tablet administered orally once daily
Intervention MeSH terms: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: prevention of chronic hepatitis B recurrence; post orthotopic liver transplant; prevention of chronic hepatitis B recurrence in patients who have undergone orthotopic liver transplant

Summary:

      The objective of this study is to provide open label emtricitabine/tenofovir disoproxil
      fumarate (FTC/TDF) for an additional 5 years (240 weeks) to adults completing study
      GS-US-203-0107.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Complete all end of study visit procedures and pharmacokinetic (PK) substudy (if
             applicable) for the GS US 203 0107 study.

          -  A negative pregnancy test is required for female individuals at the end of study visit
             for GS US 203 0107 (unless surgically sterile or greater than two years
             post-menopausal).

          -  All sexually active female individuals who are not post menopausal, or surgically
             sterile and are of childbearing potential must agree to use a highly effective method
             of contraception during heterosexual intercourse throughout the study.

          -  Male individuals who are sexually active are required to use barrier contraception
             (condom with spermicide) during heterosexual intercourse through to study completion.

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Bone Marker Assessment of Multiple Myeloma Patients Treated With Aminobisphosphonates
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Zoledronic acid
Intervention description: 4mg IV over at least 15 minutes or corrected for creatinine clearance x 1
Intervention MeSH terms: Zoledronic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: aminobisphosphonates

Summary:

      The purpose of this research study is to define the time a molecule in the participants bones
      called NTX begins to rise after receiving treatment with bisphosphonates. NTX is measured in
      the urine to determine the rate of bone breakdown. Tracking this marker may help identify a
      more optimal dosing schedule of bisphosphonate therapy. Bisphosphonate drugs like zoledronic
      acid, which will be used in this study, are used to reduce pain and bone fractures in people
      with multiple myeloma. There is some laboratory data to suggest that they may work against
      myeloma. Participants will have already undergone bisphosphonate therapy and may have
      received zoledronic acid as treatment. Typically these agents are continued indefinitely. Due
      to concerns of their long-term side effects we are looking at alternate strategies for
      reducing the frequency of these agents.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women 18 years of age or older

          -  Confirmed diagnosis of multiple myeloma(MM) by Durie and Dalmon staging criteria on IV
             bisphosphonate therapy with either pamidronate or zoledronic acid for 8-12 months

          -  MM patients in either CR (complete response) or PR (partial response) by EBMT criteria

          -  ECOG Performance Status of 0-2

        Exclusion Criteria:

          -  MM patients on active anti-MM therapy (maintenance regimens allowed)

          -  Renal failure with serum creatinine >2mg/dL and/or creatinine clearance of <30ml/min

          -  Relapsed, refractory or progressive disease

          -  Any condition or situation that, in the opinion of the investigator, may put the
             subject at significant risk, confound the results of the study, or interfere
             significantly with the subject's participation in the study

          -  Hypersensitivity or any contraindication to a single dose of zoledronic acid
Efficacy and Safety of IBI-10090 in Ocular Surgery Patients
Condition: Inflammation Associated With Cataract Surgery
MeSH terms: Cataract; Inflammation
Intervention: IBI-10090
Intervention description: dexamethasone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 172.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: cataract surgery; ocular inflammation

Summary:

      This study will test the efficacy and safety of IBI-10090 in the treatment of ocular
      inflammation after ocular surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients scheduled for unilateral cataract surgery

        Exclusion Criteria:

          -  Ocular, topical, or oral corticosteroids within 7 days of Day 0
Vitamin D3 Effects on Musculoskeletal Symptoms With Use of Aromatase Inhibitors
Condition: Muscle Pain; Joint Pain
MeSH terms: Arthralgia; Myalgia
Intervention: Vitamin D3; Vitamin D3
Intervention description: Cholecalciferol capsule, 4000IU, daily for 6 months; cholecalciferol capsule, 600 IU, daily for 6 months
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 116.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The Purpose of this study is to determine whether vitamin D3 supplements will decrease the
      muscle and bone pain that are reported by women who take Aromatase Inhibitors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years

          -  Women with a history of stage I-IIIa invasive breast cancer

          -  History of hormone-receptor positive cancer (either ER + or PR + or both)

          -  Are prescribed and are taking anastrozole, letrozole or exemestane for at least one
             month and have at least 7 months of AI treatment remaining

          -  Are experiencing AIMSS

        Exclusion Criteria:

          -  Unable to read or understand English

          -  History of psychiatric disability affecting informed consent or compliance with drug
             intake

          -  Malabsorption syndrome or inability to take oral medication

          -  Has less than 7 months of AI therapy remaining