bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Intrathecal Oxytocin in Patients With Neuropathic Pain
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Intervention: oxytocin 100 micrograms; Normal Saline (preservative free)
Intervention description: oxytocin 100 micrograms administered intrathecally (IT); Normal Saline (preservative free) administered intrathecally (IT)
Intervention MeSH terms: Oxytocin
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: chronic pain; neuropathic pain

Summary:

      The purpose of the study is to determine the effect of oxytocin given into the spinal fluid
      on pain and areas and intensity of hyperalgesia and allodynia in patients with chronic
      neuropathic pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Weight < or equal to 240 pounds

          -  Neuropathic pain for > 6 months: with primary pain area below the umbilicus

        Exclusion Criteria:

          -  Hypersensitivity, allergy, or significant reaction to any ingredient of the study drug
             or lidocaine

          -  Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the
             Principal Investigator, would place the subject at increased risk (active gynecologic
             disease in which increased tone would be detrimental e.g., uterine fibroids with
             ongoing bleeding), compromise the subject's compliance with study procedures, or
             compromise the quality of the data

          -  Pregnancy

          -  spinal cord stimulators, chronic intrathecal drug therapy, or oral opioid treatment
             for > 3 months at a current dose of > 100 milligram (mg) morphine per day or
             equivalent.
Study of Dupilumab Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Dupilumab; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 380.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Eczema

Summary:

      To assess the efficacy of multiple dupilumab dose-regimens, compared to placebo, in adult
      participants with moderate-to-severe atopic dermatitis (AD).
    

Eligibility criteria:

        The inclusion criteria included, but were not limited to, the following:

          1. Chronic Atopic Dermatitis that had been present for at least 3 years

          2. History of inadequate response to out-patient treatment with topical medications, or
             for whom topical treatments were otherwise inadvisable (e.g, because of important side
             effects or safety risks)

          3. Willing and able to comply with all clinic visits and study-related procedures

        The exclusion criteria included, but were not limited to, the following:

          1. Prior treatment with dupilumab (REGN668/SAR231893)

          2. Presence of certain laboratory abnormalities at the screening visit

          3. Treatment with an investigational drug within 8 weeks of baseline visit

          4. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit

          5. Certain other treatments and medical procedures undertaken within a particular time
             frame prior to the baseline visit

          6. Known history of human immunodeficiency virus (HIV) infection

          7. History of malignancy within 5 years before the baseline visit (with certain
             exceptions)

          8. Planned surgical procedure during the length of the study

          9. High risk of parasite infection

         10. Any other medical or psychological condition that in the opinion of the investigator
             or the sponsor's medical monitor, would place the participants at risk, interfere with
             participation in the study or interfere with interpretation of study results

         11. Pregnant or breast-feeding women
A Study to Assess the Effect of QAW039 in Non-atopic Asthmatic Patients
Condition: Asthma
MeSH terms: Asthma
Intervention: QAW039; Placebo QAW039; Fluticasone 250 mcg; Fluticasone 100 mcg
Intervention description: QAW039 supplied as hard gelatin capsule in unit dose strength of 150 mg. Patient took 450 mg once daily (3 capsules taken with food in the morning) for the approximate period of the study (12 weeks); Matching placebo for QAW039 supplied as hard gelatin capsule were identical in appearance to their active counterparts. Patients took 3 QAW039 matching placebo capsules once a day ( taken with food in the morning) for the approximate period of the study (12 weeks); Fluticasone was supplied in inhalers with dose strength of 250 mcg. Patients took 250 mcg bid (morning and evening approximately 12 hours between doses) for a total dose of 500 mcg daily for the approximate period of the study (12 weeks).; Background therapy - fluticasone was supplied in inhalers with dose strength of 100 mcg. All patients in the study other than the Atopic Fluticasone 150 mcg arm were given the 100 mcg dose strength inhalers and took fluticasone 100 mcg bid (taken morning and evening with approximately 12 hours between doses) as background therapy for the approximate period of the study (12 weeks).
Intervention MeSH terms: Fluticasone; Xhance; Indoleacetic Acids
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 345.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study was to assess the clinical effect of QAW039 in non-atopic asthmatics
      taking low dose Inhaled Corticosteroid (ICS) as background therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent must be obtained before any assessment is performed

          -  Patients with a diagnosis of persistent asthma (according to Global Initiative for
             Asthma 2011) for a period of at least 6 months prior to screening

          -  Patients with a pre-bronchodilator Forced Expiratory Volume In One Second (FEV1) value
             of 40% to 80% of individual predicted value at screening and prior to treatment

          -  An Asthma Control Questionnaire score ≥ 1.5 prior to treatment

          -  Demonstration of reversible airway obstruction

        Exclusion Criteria:

          -  Pregnant or nursing (lactating) women

          -  Acute illness other than asthma at the start of the study

          -  Patients with clinically significant laboratory abnormalities at screening

          -  Patients with clinically significant condition which may compromise subject safety or
             interfere with study evaluation

          -  Use of other investigational drugs at the time of enrollment
The Efficacy and Safety of Hypertonic Saline in Cardiac Surgery Patients.
Condition: Coronary Artery Disease; Edema
MeSH terms: Coronary Artery Disease
Intervention: 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5; 0.9% NaCl
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 40.0
Sex: All
Minimum age: 30 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Organ dysfunction; Hypertonic solution; Extravascular water; Cardiopulmonary Bypass

Summary:

      The organ dysfunction following cardiopulmonary bypass (CPB) occurs frequently in cardiac
      surgery patients. Systemic inflammatory response initiated by CPB through releasing of
      several mediators lead to altered endothelial integrity and in consequence the leakage of
      proteins and fluids from the intravascular to the interstitial compartment is occurred.
      Increased capillary permeability and decreased colloid osmotic pressure were shown to play a
      key role for fluid shift and increasing of extravascular water. Further tissue edema can
      result in injury to many organs, including the heart, lungs, brain, kidneys and can lead to
      adverse outcomes.

      Hypertonic solution creates an osmotic gradient across the cellular membrane, causing a fluid
      shift from the intracellular and the interstitial spaces of tissue into the intravascular
      compartment.

      The purpose of this study is to investigate the efficacy and safety of 7.2% NaCl plus 6%
      hydroxyethyl starch 200/0.5 in patients scheduled for first-time coronary artery bypass
      grafting with cardiopulmonary bypass.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients scheduled for first-time coronary artery bypass grafting with cardiopulmonary
             bypass

        Exclusion Criteria:

          -  age >70 years

          -  body mass index <18 and >35 kg/m2

          -  left ventricular ejection fraction <40%

          -  myocardial infarction <6 months before surgery

          -  stroke or transient ischemic attack <12 months before surgery

          -  diabetes mellitus

          -  glomerular filtration rate <90 mL/min

          -  emergency surgery

          -  hematocrit <30%.
Pilot Study Investigating Safety and Efficacy of Tadalafil as Treatment for Benign Prostatic Hyperplasia (BPH) in Asian Men
Condition: Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Intervention: Tadalafil; Placebo; Tamsulosin
Intervention description: 5 mg once a day; once a day; 0.2 mg once a day
Intervention MeSH terms: Tadalafil; Tamsulosin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 151.0
Sex: Male
Minimum age: 45 Years
Healthy volunteers: No

Summary:

      The primary purpose of this clinical trial is to evaluate the change in the International
      Prostate Symptom Score (IPSS) total score from the beginning of the study to the end of the
      study for subjects randomized to tadalafil 5mg once a day dosing and placebo once a day
      dosing for 12 weeks of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have Benign Prostatic Hyperplasia - Lower Urinary Tract Symptoms (BPH-LUTS) for at
             least 6 months prior to Visit 1.

          -  Agree not to use any other approved or experimental treatments for erectile
             dysfunction or BPH-LUTS during the study.

          -  Have not taken Finasteride therapy for at least 3 months prior to Visit 2.

          -  Have not taken Dutasteride therapy for at least 6 months prior to Visit 2.

          -  Have an International Prostate Symptom Score (IPSS) total score greater than or equal
             to 13 at Visit 2.

        Exclusion Criteria:

          -  Prostate Specific Antigen (PSA) greater than 10.0 nanograms per milliliter (ng/mL) at
             Visit 1.

          -  Bladder Post Void Residual (PVR) greater than or equal to 300 mL by ultrasound at
             Visit 1.

          -  History of pelvic surgery, prostatectomy, radiotherapy, penile implant surgery, lower
             urinary tract malignancy or trauma.

          -  Urinary tract infection or inflammation or current antibiotic therapy for urinary
             tract infection at Visit 1.

          -  Glycosylated hemoglobin (HbA1c) greater than 9% at Visit 1.
An Outpatient Study Of The Efficacy, Safety, And Tolerability Of PF-02545920 In The Adjunctive Treatment Of Sub-Optimally Controlled Symptoms of Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: PF-02545920; Placebo; PF-02545920
Intervention description: PF-02545920 2 mg BID x 7 days, then 5 mg BID until the Week 12 visit; Placebo BID until the Week 12 visit; PF-02545920 5 mg BID x 7 days, then 10 mg BID x 7 days, then 15 mg BID until the Week 12 visit
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 240.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: PF-02545920; schizophrenia; outpatient; safety; efficacy; suboptimal response

Summary:

      This study aims to evaluate whether PF-02545920 is safe and effective in the treatment of
      sub-optimally controlled symptoms of schizophrenia during a 12-week outpatient treatment
      period. The study will use the Positive and Negative Syndrome Scale (PANSS) to measure change
      in symptoms for PF-02545920 from baseline compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Psychiatrically stable subjects with schizophrenia who have had a suboptimal response
             to current treatment

          -  Evidence of stable schizophrenia symptomatology greater than or equal to 3 months.

          -  Subjects must be on a stable medication treatment regimen greater than or equal to 2
             months, including concomitant psychotropic medications.

        Exclusion Criteria:

          -  History of seizures or of a condition with risk of seizures.

          -  Subjects with schizophrenia that have not responded at all to current treatment.

          -  Pregnant or nursing females, and females of child bearing potential.
131I-MIBG Alone VS. 131I-MIBG With Vincristine and Irinotecan VS131I-MIBG With Vorinostat
Condition: Neuroblastoma
MeSH terms: Neuroblastoma
Intervention: 131I-MIBG; Vincristine; Irinotecan; Vorinostat
Intervention MeSH terms: Irinotecan; Vincristine; Vorinostat; 3-Iodobenzylguanidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 114.0
Sex: All
Minimum age: 2 Years
Maximum age: 30 Years
Healthy volunteers: No

Summary:

      This study will compare three treatment regimens containing metaiodobenzylguanidine (MIBG)
      and compare their effects on tumor response and associated side effects, to determine if one
      therapy is better than the other for people diagnosed with relapsed or persistent
      neuroblastoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be > 24 months and < 30 years of age when registered on study.

          -  Patients must have relapsed neuroblastoma, refractory neuroblastoma that had less than
             a partial response to standard treatment or persistent neuroblastoma that had at least
             a partial response to frontline therapy frontline therapy with > 3 residual lesions on
             end-induction MIBG scan.

          -  Patients must have evidence of MIBG uptake into tumor at ≥ one site within 4 weeks
             prior to entry on study and subsequent to any intervening therapy.

          -  Patients must have adequate heart, kidney, liver and bone marrow function. Patients
             who have bone marrow disease must still have adequate bone marrow function to enter
             the study.

          -  Patients must have a dose of unpurged peripheral blood stem cells is 2.0 x 106 viable
             CD34+ cells/kg available.

        Exclusion Criteria:

          -  They have had previous I-131 MIBG therapy

          -  They have other medical problems that could get much worse with this treatment.

          -  They are pregnant or breast feeding.

          -  They have a history of a venous or arterial thrombosis that was not associated to a
             central line.

          -  They have active infections such as hepatitis or fungal infections.

          -  They have active diarrhea.

          -  They have had an allogeneic stem cell transplant (received stem cell from someone
             else)

          -  They can't cooperate with the special precautions that are needed for this trial.
A Safety & Efficacy Study of BGS649 in Women With Refractory Endometriosis
Condition: Pelvic Pain Associated With Refractory Endometriosis
MeSH terms: Endometriosis; Pelvic Pain
Intervention: BGS649; Placebo
Intervention description: 0.1 mg capsules for oral administration. A total dose of 3 capsules of BGS649 0.1mg will be administered at randomization, week 4, and week 8 at the study site.; Placebo matching BGS649 will be provided by Novartis as capsules for oral administration. Three capsules of placebo will be administered at randomization, week 4, and week 8 at the study site.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 27.0
Sex: Female
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: No
Keywords: Menstrual pain; Refractory endometriosis; Pelvic pain

Summary:

      The purpose of this study is to determine efficacy, safety, tolerability and pharmacokinetics
      of multiple doses of BGS649 with concurrent daily administration of combined oral
      contraception in patients with refractory endometriosis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have surgical diagnosis of endometriosis est. w/in 5 years before screening.
             Subjects must have self reported moderate to severe pelvic pain at screening to be
             confirmed during the run-in-phase

          -  Subjects with moderate to severe pelvic pain who were refractory to surgery
             (persistent or recurrent pelvic pain within 24 months after any therapeutic surgery)
             and at least two hormonal therapies from two different classes, including one approved
             hormonal therapy

        Exclusion Criteria:

          -  Subjects who have undergone hysterectomy or bilateral oophorectomy.

          -  Surgical treatment of endometriosis within 3 months before screening.

          -  Subjects who are pregnant or who were pregnant within 3 months of visit one.

          -  Subjects who are nursing or lactating

          -  Subjects who are tobacco smokers.

        Other protocol-defined inclusion/exclusion criteria may apply
20-Week Repeat Oral Dose Study of AKB-6548 in Participants With Chronic Kidney Disease and Anemia
Condition: Anemia; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Intervention: AKB-6548; Placebo
Intervention description: Oral dose administered once daily for 20 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.; Oral Placebo administered once daily for 20 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 210.0
Sex: All
Minimum age: 18 Years
Maximum age: 82 Years
Healthy volunteers: No
Keywords: anemia; chronic kidney disease; CKD; chronic renal insufficiency; renal impairment; erythropoietin; kidney; oral anemia treatment; hemoglobin; hypoxia-inducible factor; HIF; hypoxia-inducible factor prolyl-hydroxylase inhibitor; HIF-PHI; efficacy; safety; pharmacokinetics

Summary:

      The purpose of this study is to evaluate the hemoglobin response (efficacy), safety, and
      tolerability of orally administered AKB-6548 in participants with Chronic Kidney Disease
      (pre-dialysis) with anemia with dosing for 20 weeks.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  18 to 82 years of age, inclusive

          -  Chronic Kidney Disease with a GFR category of G3a-G5 and not yet on dialysis

          -  eGFR ≥ 10 and ≤ 65 mL/minute/1.73 m2

          -  Anemia secondary to CKD with an ESA status and a Screening HGB as per protocol

          -  Iron replete with ferritin and TSAT levels as defined per protocol

        Key Exclusion Criteria:

          -  BMI > 44.0 kg/m2

          -  Red blood cell transfusion within 11 weeks prior to the Screening visit

          -  Androgen therapy within the previous 21 days prior to the Screening visit

          -  Intravenous iron within the past 4 weeks prior to the Screening visit

          -  AST or ALT >1.8x ULN, alkaline phosphatase >2x ULN, or total bilirubin >1.5x ULN

          -  Screening ECG with QTc > 500 msec

          -  Uncontrolled hypertension

          -  Class III or IV congestive heart failure

          -  Myocardial infarction, acute coronary syndrome, or stroke within 6 months prior to the
             Screening visit
Growth Hormone Deficiency in Chronic Heart Failure: A Preliminary Trial
Condition: Heart Failure; Growth Hormone Deficiency; Ischemic Heart Disease
MeSH terms: Dwarfism, Pituitary; Heart Failure; Heart Diseases; Myocardial Ischemia; Coronary Artery Disease; Endocrine System Diseases
Intervention: Somatotropin
Intervention description: Subcutaneous Somatotropin (recombinant human Growth Hormone) 0.012 mg/kg every second day for 6 months
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Heart Failure; Growth Hormone; Anabolism; Anabolic Deficiency; Hormone replacement

Summary:

      The aim of this study is to investigate the potential benefits of the correction of growth
      hormone (GH) deficiency with GH replacement therapy in patients with chronic heart failure
      due to left ventricular systolic dysfunction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Heart Failure in ew York Heart Association functional class II to IV

          -  Left ventricular end diastolic diameter > 60 mm

          -  Left ventricular ejection fraction < 40%

          -  Growth Hormone Deficiency (defined as a peak GH response to intravenous stimulation
             with GHRH + Arginine < 9 ng/dl)

          -  Age 18-80 years

          -  Clinical stability, guideline-oriented maximal pharmacological therapy

          -  Informed consent

        Exclusion Criteria:

          -  Active Myocarditis

          -  Hypertrophic Cardiomyopathy

          -  Active endocarditis

          -  Active malignancy

          -  End stage renal disease

          -  Severe liver disease (Child B-C)