bioihbjkbjnl/mcl2 huggingface dataset:
Continuing Treatment for Subjects Who Have Participated on a Prior Protocol Investigating Dasatinib
Condition: Multiple Indications Cancer
Intervention: Dasatinib
Intervention MeSH terms: Dasatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to continue to provide dasatinib to patients that are currently
      participating in another dasatinib trial that is ending and for which there is no other
      option to provide dasatinib.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Participated in and completed a previous dasatinib protocol (including but not limited
             to CA180056, CA180363 or CA180227) and is deemed by the investigator to be deriving
             benefit from dasatinib as defined by the previous protocol

          -  Receiving dasatinib at the time of signature of informed consent

          -  Males and Females, ages 18 and older

        Exclusion Criteria:

          -  All patients previously discontinued from a dasatinib study for any reason

          -  Any serious or uncontrolled medical disorder or active infection that would impair the
             ability of the subject to receive protocol therapy

          -  History of allergy to dasatinib
Trial of Exemestane +/- MM-121 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive and/or Progesterone Receptor Positive Her2 Negative Breast Cancer
Condition: Her2 Negative Breast Cancer Patients
MeSH terms: Breast Neoplasms
Intervention: MM-121; Placebo; Exemestane
Intervention description: MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week; Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week and exemestane (25 mg) administered orally once per day; Exemestane (25 mg) administered orally once per day
Intervention MeSH terms: Exemestane
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 118.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast Cancer; Her2 negative; Estrogen Receptor Positive; Progesterone Receptor Positive; MM-121; Exemestane; Postmenopausal Women

Summary:

      To determine whether the combination MM-121 + Exemestane in ER+ and/or PR+ breast cancer
      patients is more effective than Exemestane alone
    

Eligibility criteria:

        Inclusion Criteria:

          -  Locally advanced or metastatic breast cancer

          -  Histologically or cytologically confirmed ER+ and/or PgR+ and Her2 negative breast
             cancer

          -  ≥ 18 years of age

        Exclusion Criteria:

          -  Received prior treatment with exemestane

          -  Extensive visceral disease (rapidly progressive, life-threatening metastases,
             including symptomatic lymphangitic metastases)

          -  Symptomatic CNS disease
Phase IIB Pilot of Atazanavir + Raltegravir
Condition: HIV
Intervention: Atazanavir; Raltegravir; Atazanavir; Ritonavir; Tenofovir/Emtricitabine
Intervention description: Capsules, Oral, 300 mg, twice daily, 96 weeks; Tablet, Oral, 400 mg, twice daily, 96 weeks; Capsules, Oral, 300 mg, once daily, 96 weeks; Capsules, Oral, 100 mg, once daily, 96 weeks; Tablet, Oral, 300-mg Tenofovir/200-mg Emtricitabine, once daily, 96 weeks
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate; Tenofovir; Emtricitabine; Raltegravir Potassium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 167.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Combination Therapy

Summary:

      The purpose of this study is to determine if the combination of atazanavir and raltegravir
      taken together is safe and effective in the treatment of human immunodeficiency virus (HIV).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Human Immunodeficiency Virus (HIV)-1 positive status

          -  HIV ribonucleic acid (RNA) level >=5000 copies/mL

          -  Antiretroviral treatment-naive

          -  Absolute Cluster of Differentiation 4 (CD4) cell count meeting 1 of the following
             criteria:

          -  <350 cells/mm^3

          -  Screening CD4 >=350 and <=500 cells/mm^3 ONLY if at least 1 of the following
             conditions apply:

               -  Screening HIV RNA level >100,000 copies/mL, or

               -  CD4 decline >50-100 cells/mm^3/year, or

               -  Age >=55 years

          -  Any CD4 cell count, if participant has a history of an acquired immune deficiency
             syndrome-defining illness

          -  Medically stable

        Exclusion Criteria:

          -  Screening HIV genotype showing resistance to any component of the study regimen
             (Atazanavir, Raltegravir, Tenofovir/Emtricitabine)

          -  Hepatitis B or hepatitis C coinfection

          -  History of or current cardiac disease

          -  Electrocardiogram findings:

          -  PR Interval >260 msec (severe 1st degree atrioventricular block)

          -  QRS Interval >120 msec
A Study of Safety and Efficacy of UNR844 Chloride (UNR844-Cl) Eye Drops in Subjects With Presbyopia.
Condition: Presbyopia
MeSH terms: Presbyopia
Intervention: UNR844-Cl; Placebo
Intervention description: 1.5% Ophthalmic solution for topical ocular administration; placebo
Intervention MeSH terms: Choline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: double-mask(Investigator, patient)
Enrollment: 125.0
Sex: All
Minimum age: 45 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Presbyopia, adults, randomized study, placebo

Summary:

      The purpose of this study was to assess the effect of topical UNR844-Cl (lipoic acid choline
      ester chloride) ophthalmic solution on near visual function in presbyopic subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent must be obtained before any assessment is performed

          -  Impaired near vision in each eye and when using both eyes, without any near correction

          -  Need a certain level of near correction

        Exclusion Criteria:

          -  Impaired distance vision in either eye, with distance correction (if any)

          -  Severe short- or long-sightedness

          -  Any significant medical or clinical conditions affecting vision, the eyes or general
             health
Efficacy and Tolerability of an Intra-Nasal Testosterone Product
Condition: Hypogonadism
MeSH terms: Hypogonadism
Intervention: Nasobol®; Androderm® (Positive Control)
Intervention description: Intra-nasal Testosterone (2 syringes), b.i.d.; QD administration
Intervention MeSH terms: Testosterone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 57.0
Sex: Male
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Primary Hypogonadism; Secondary Hypogonadism

Summary:

      This clinical trial is being performed to compare the pharmacokinetic profile of testosterone
      after repeated intra-nasal administration of products of different strengths in subjects with
      hypogonadism.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men with primary or secondary hypogonadism and a serum morning (0900 h ± 30 minutes)
             testosterone levels >100 ng/dl and ≤ 300 ng/dL.

          -  Normal Otolaryngological nasal endoscopy examination.

          -  Normal prostate examination (no palpable prostatic mass), and serum PSA ≤ 4.0 ng/mL.

        Exclusion Criteria:

          -  Current treatment with other androgens (i.e. DHEA), anabolic steroids or other sex
             hormones

          -  Treatment with Estrogens, GnRH antagonists, or Growth Hormone within previous 12
             months

          -  History of nasal surgery, specifically turbinoplasty, septoplasty, rhinoplasty, or
             sinus surgery.

          -  History of nasal disorders (e.g. polyposis, recurrent epistaxis ( > 1 nose bleed per
             month, abuse of nasal decongestants) or sleep apnea.
A Gene Therapy Study for Hemophilia B
Condition: Hemophilia B
MeSH terms: Hemophilia A; Hemophilia B
Intervention: SPK-9001
Intervention description: A novel, bioengineered adeno-associated viral vector carrying human factor IX variant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hemophilia B; Blood Coagulation Disorders; Gene Therapy; Gene Transfer; Factor IX Deficiency; Factor IX Gene; Factor IX Protein; Vector; AAV

Summary:

      A Phase 1/2, Open-Label, Non-Randomized, Dose-Escalation Study of SPK-9001 in Subjects with
      Hemophilia B.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to provide informed consent and comply with requirements of the study

          -  Males ≥18 y.o. with confirmed diagnosis of hemophilia B (≤2 IU/dL or ≤2% endogenous
             factor IX)

          -  Received ≥50 exposure days to factor IX products

          -  A minimum average of 4 bleeding events per year requiring episodic treatment of factor
             IX infusions or prophylactic factor IX infusions

          -  No measurable factor IX inhibitor as assessed by the central laboratory and have no
             prior history of inhibitors to factor IX protein

          -  Agree to use reliable barrier contraception until 3 consecutive samples are negative
             for vector sequences

        Exclusion Criteria:

          -  Evidence of active hepatitis B or C

          -  Currently on antiviral therapy for hepatitis B or C

          -  Have significant underlying liver disease

          -  Have serological evidence* of HIV-1 or HIV-2 with CD4 counts ≤200/mm3 (* subjects who
             are HIV+ and stable with CD4 count >200/mm3 and undetectable viral load are eligible
             to enroll)

          -  Neutralizing antibodies reactive with AAV-Spark100 above and/or below a defined titre

          -  Participated in a gene transfer trial within the last 52 weeks or in a clinical trial
             with an investigational drug within the last 12 weeks

          -  Unable or unwilling to comply with study assessments
Traditional Chinese Medicine in the Treatment of Patients With Hyperuricemia.
Condition: Hyperuricemia
MeSH terms: Hyperuricemia
Intervention: Wu Ling San; Yin-Chen Wu Ling San; Placebo
Intervention description: assigned to Wu Ling San (n =20) and were instructed to take 4.5 gm 2 times per day of Wu Ling San for a period of 4 weeks.; assigned to Yin-Chen Wu Ling San (n =20) and were instructed to take 4.5 gm 2 times per day of Yin-Chen Wu Ling San for a period of 4 weeks.; 1/10 Wu Ling San assigned to Placebo (n =20) and were instructed to take 4.5 gm 2 times per day of Placebo for a period of 4 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      To testify the efficacy and safety of traditional Chinese formulae, "Wu-Ling San" and
      "Yin-Chen Wu-Ling San" for patients with hyperuricemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  serum uric acid > 8 mg/dL

        Exclusion Criteria:

          -  1. gout attack within 2 weeks before baseline 2. drug for control urine acid must be
             stable dose within 2 weeks before baseline
             (e.g.allopurinol、benzbromarone、probenecid、sulfinpyrazone) 3. subject taking the drug
             involved azathioprine、aspirin (>325
             mg)、atorvastatin、fenofibrate、losartan、thiazide、systemic corticosteroid、estrogen、oral
             contraceptive pills 4. serum creatinine > 3.0 mg/dL 5. GPT > 100 mg/dL 6. Pregnant or
             breast-feeding women 7. Chemotherapy or radiation therapy in cancer patients
An Open-Labeled Exploratory Study to Evaluate Safety and Efficacy of FB825 in Adults With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: FB825, FB825-15D11, Anti-CemX
Intervention description: Pharmaceutical form: 20mg/ml solution Route of administration: IV
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the Safety and Efficacy of FB825 in Adults with
      Atopic Dermatitis
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subjects between 20 and 65 years of age, inclusive.

          2. The subject has a physician-confirmed diagnosis of chronic atopic dermatitis based on
             3 years history of symptoms defined by the Eichenfield revised criteria of Hannifin
             and Rajka and supported by positive allergen-specific IgE at the screening visit.

          3. Eczema Area and Severity Index (EASI) score ≧14 at the screening and baseline visits.

          4. Investigator's Global Assessment (IGA) score ≧ 3 (5-point scale) at the screening and
             baseline visits.

          5. ≧10 % body surface area (BSA) of AD involvement at the screening and baseline visits.

        Exclusion Criteria:

          1. Female subjects who are pregnant or lactating.

          2. The subject is on diet or with poor intake.

          3. The subject has a history of heart arrhythmias (any clinically relevant).

          4. The subject has a positive test result for hepatitis B surface antigen, hepatitis C
             virus antibody, or human immunodeficiency virus types 1 and 2 antibodies at screening.

          5. The subject has a history of alcohol or drug abuse that would impair or risk the
             patients' full participation in the study, in the opinion of the investigator.
A Safety and Efficacy Study of LiRIS® in Females With Interstitial Cystitis With Hunner's Lesions
Condition: Cystitis, Interstitial; Ulcer
MeSH terms: Cystitis; Cystitis, Interstitial
Intervention: LiRIS®; LiRIS Placebo
Intervention description: LiRIS® is a drug-device combination product which is placed in the bladder during cystoscopy and remains in the bladder, gradually releasing lidocaine until removed from the bladder via cystoscopy.; LiRIS placebo is a drug-device combination product, matching the LiRIS® which is placed in the bladder during cystoscopy, remains in the bladder until removed from the bladder via cystoscopy
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 59.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a safety and efficacy study of LiRIS® in females with interstitial cystitis with
      Hunner's lesions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of interstitial cystitis with Hunner's lesions/ulcers

        Exclusion Criteria:

          -  Previous treatment with LiRIS®

          -  Interstitial cystitis/bladder pain syndrome, without Hunner's lesions/ulcers
Bicarbonate in Patients With Out-of-hospital Cardiac Arrest
Condition: Cardiac Arrest; Metabolic Acidosis
MeSH terms: Heart Arrest; Out-of-Hospital Cardiac Arrest; Acidosis
Intervention: Sodium bicarbonate; Normal saline
Intervention description: Administer Sodium bicarbonate 50 mEq IV over 2 minutes; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Sodium Bicarbonate

Summary:

      A pilot study to evaluate the effect of sodium bicarbonate administration on cardiopulmonary
      resuscitation results and outcomes in cardiac arrest patient with severe metabolic acidosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult cardiac arrest patient with arterial pH <7.1 or bicarbonate <10mmEq/L checked at
             10 minutes of cardiopulmonary resuscitation

        Exclusion Criteria:

          -  age <18 trauma patient Do Not Resuscitate state
Brain Function and Structure in Cocaine Dependence
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Intervention: Citalopram; Placebo
Intervention description: 20 mg or 40 mg daily for 8 weeks; Placebo daily for 8 weeks
Intervention MeSH terms: Dexetimide; Citalopram; Escitalopram
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: substance abuse; cocaine; impulsivity; serotonin; MRI

Summary:

      The purpose of this study is to examine the role of brain MRI findings in predicting
      treatment outcomes among individuals with cocaine dependence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects age 18 to 50 who meet current DSM-IV criteria for cocaine
             dependence who are seeking treatment.

        Exclusion Criteria:

          1. Current DSM-IV diagnosis of any psychoactive substance dependence other than cocaine,
             marijuana, nicotine, or alcohol

          2. Have a DSM-IV axis I psychiatric disorder or neurological disease or disorder
             requiring ongoing treatment and/or making study participation unsafe

          3. Significant current suicidal or homicidal ideation

          4. Medical conditions contraindicating citalopram pharmacotherapy (liver disease, seizure
             disorder, bleeding disorder, or prolonged QT interval on EKG)

          5. Taking CNS active concomitant medications

          6. Taking medications known to have significant drug interactions with the study
             medication

          7. Having conditions of probation or parole requiring reports of drug use to officers of
             the court

          8. Impending incarceration

          9. Pregnant or breast feeding for female patients

         10. Inability to read, write, or speak English

         11. Having plans to leave the immediate geographical area within 3 months

         12. Unwillingness or not competent to sign a written informed consent form

         13. Individuals who have pacemakers, metal or electromechanical implants or metallic
             foreign bodies

         14. Patients who are known to be HIV positive will not be included due to possible CNS
             effects of HIV.

         15. Alcohol withdrawal symptoms or history of significant previous alcohol withdrawal
             symptoms.
Efficacy, Safety and Tolerability of Romosozumab in the Treatment of Japanese Women With Postmenopausal Osteoporosis
Condition: Postmenopausal Osteoporosis (PMO)
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: Romosozumab; Placebo
Intervention description: Administered by subcutaneous injection; Administered by subcutaneous injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 252.0
Sex: Female
Minimum age: 55 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Osteoporosis, Osteoporosis-Postmenopausal, Bone Diseases-Metabolic, Bone Diseases, Musculoskeletal Diseases

Summary:

      The purpose of this study is to determine if treatment with romosozumab increases bone
      mineral density in Japanese women with postmenopausal osteoporosis.
    

Eligibility criteria:

        Inclusion Criteria:

        Ambulatory, postmenopausal Japanese women with osteoporosis (defined as bone mineral
        density T-score of ≤ -4.00 at the lumbar spine or BMD T-score of ≤ -3.50 at the total hip,
        or femoral neck)

        Exclusion Criteria:

          -  Severe osteoporosis

          -  Use of agents affecting bone metabolism

          -  History of metabolic or bone disease (except osteoporosis)

          -  Vitamin D insufficiency (vitamin D repletion and rescreening is permitted)

          -  Current hyper- or hypocalcemia

          -  Current, uncontrolled hyper- or hypothyroidism

          -  Current, uncontrolled hyper- or hypoparathyroidism
Efficacy of Spinal Oxytocin in Healthy Volunteers
Condition: Healthy Volunteer Study
Intervention: Oxytocin 15 mcg; Oxytocin 150 mcg; Placebo
Intervention description: Oxytocin 15 mcg will be administered spinally; Oxytocin 150 mcg will be administered spinally; placebo will be administered spinally
Intervention MeSH terms: Oxytocin
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects are randomized into one of 3 groups to receive, in a double-blind manner, intrathecal saline or intrathecal oxytocin, 15 mcg or 150 mcg
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Randomization is prepared by a statistician not otherwise involved in the study or data analysis and is maintained by the Wake Forest University School of Medicine research pharmacy. Study drug is dispensed by the research pharmacy labelled as "Study drug containing normal saline or oxytocin 15 mcg in normal saline or oxytocin 150 mcg in normal saline" to indicate the possible contents of the solution, thereby maintaining blind.
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 59 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine the effect of intrathecal oxytocin on areas and
      intensity of hyperalgesia and allodynia induced by topical capsaicin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy

          -  weight < 240 pounds

          -  American Society of Anesthesiology Category 1 or 2

        Exclusion Criteria:

          -  allergy to oxytocin or lidocaine

          -  allergy to chilli peppers

          -  Females: active gynecological disease such as uterine fibroids or ongoing bleeding

          -  Pregnancy or currently breastfeeding

          -  Females that have delivered a baby within 2 years of study

          -  Taking prescription medications (exception: oral birth control medication)