bioihbjkbjnl/mcl2 huggingface dataset:
Oral 6R-BH4 for the Treatment of Isolated Systolic Hypertension and Endothelial Dysfunction
Condition: Isolated Systolic Hypertension; Endothelial Dysfunction
MeSH terms: Hypertension; Isolated Systolic Hypertension; Systolic Murmurs
Intervention: 6R-BH4; Placebo
Intervention description: 6R-BH4 5mg/kg or Placebo BID for four weeks and then 8 week dose-escalation period; placebo given BID for entire length of study
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 3.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Isolated Systolic Hypertension with Endothelial Dysfunction

Summary:

      This study is designed to assess the safety and efficacy of twice-daily oral dosing of 6R-BH4
      to improve endothelial function, reduce systolic blood pressure and reduce arterial
      stiffness.
    

Eligibility criteria:

        Inclusion Criteria:

          -  No change in prescribed antihypertension medications within the previous 30 days

          -  Study staff able to visualize and measure the brachial artery diameter by high
             resolution vascular ultrasound required for FMD measurements

          -  ISH with the following mean seated BP: SBP > 145 and < 180 mmHg. Diastolic blood
             pressure < 90mmHg

        Exclusion Criteria:

          -  Has known hypersensitivity to 6RBH4 or its excipients

          -  Pregnant or breastfeeding at screening

          -  Use of any investigational product or investigational medical device within 30 days
             prior to screening

          -  Current disease or condition that would interfere with study participation or safety
             such as the following: heart failure, atrial fibrillation, aortic valve disease,
             bleeding disorders, history of repeated syncope or vertigo, severe GERD, GI ulcer,
             symptomatic coronary or peripheral vascular disease, arrhythmia, serious neurologic
             disorders including seizures, organ transplant or organ failure

          -  Hypertension secondary to other medical conditions

          -  Any severe comorbid condition that would limit life expectancy to <6 months

          -  Current use of any nicotine containing substances

          -  History of drug or alcohol abuse

          -  MI, stroke or surgery within 90 days before Screening Visit

          -  CABG within 6 months before the Screening Visit

          -  Serum creatinine >2.0mg/dl or AST, ALT, GGT levels >2times upper limit of normal

          -  Concomitant treatment with: any drug known to inhibit folate metabolism, any
             phosphodiesterase-5 or -3 inhibitor

          -  Previous treatment with any formulation of BH4
Study Evaluating the Safety and Efficacy of Proellex® in the Treatment of Endometriosis-extension Study
Condition: Endometriosis
MeSH terms: Endometriosis
Intervention: Proellex®
Intervention description: one (1) 25 mg capsule daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: Female
Minimum age: 18 Years
Maximum age: 48 Years
Healthy volunteers: No
Keywords: Endometriosis; Pelvic pain; Oral progesterone blocker

Summary:

      ZPE-201 Extension of treatment
    

Eligibility criteria:

        Inclusion Criteria:

          -  Only subjects treated in the ZPE-201 study will be allowed to enter the extension
             study.

          -  Subjects who withdrew from ZPE-201 due to lack of treatment efficacy will also be
             invited to participate.

        Exclusion Criteria:

          -  All other subjects
A Study to Assess Efficacy and Safety of SER-287 in Adults With Active Mild-to-Moderate Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Vancomycin Pre-Treatment; Placebo for Vancomycin Pre-Treatment; SER-287; Placebo for SER-287
Intervention description: Four times per day dosing of vancomycin pre-treatment; Four times per day dosing of placebo pre-treatment; Once-daily dosing of SER-287; Once-daily dosing of Placebo for SER-287
Intervention MeSH terms: Vancomycin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 203.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: microbiome

Summary:

      A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter Study to Assess
      Efficacy and Safety of SER-287 in Adults with Active Mild-to-Moderate Ulcerative Colitis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented diagnosis of UC at least three months prior to screening, and with a
             minimum disease extent of 15 cm from the anal verge

          -  Active mild-to-moderate UC

          -  Inadequate response to, loss of response to, or intolerance of, at least one of the
             following conventional therapies: 5-ASA compounds, corticosteroids, 6-mercaptopurine
             (6-MP) or azathioprine (AZA), anti-TNFα, anti-integrin or tofacitinib

        Exclusion Criteria:

          -  Known history of Crohn's disease

          -  No previous history of treatment for UC (treatment-naïve)

          -  Subjects on steroid medication who are unable to have steroids tapered and be
             completely off steroids at least two weeks prior to screening

          -  Unable to stop steroid enemas or suppositories, or 5-ASA enemas or suppositories, at
             least two weeks prior to screening

          -  Subjects who have received any investigational or approved biologic therapy within
             eight weeks or five half-lives prior to screening (whichever is longer)

          -  Subjects who have received any investigational or approved non-biologic therapy,
             except for those specifically listed in the Permitted Concomitant Medications, for the
             treatment of underlying disease, within 30 days or five half-lives prior to screening
             (whichever is longer)

          -  Major gastrointestinal surgery (not including appendectomy or cholecystectomy) within
             two months before screening, or any history of total colectomy
Atomoxetine Phase 2 Study in Japanese Adult Patients With Attention Deficit/Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Atomoxetine
Intervention description: 40 mg/day every day (QD), by mouth (PO), for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
Intervention MeSH terms: Atomoxetine Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Factorial Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective is to assess overall safety and tolerability of atomoxetine in doses up to 120
      mg/day in Japanese adult patients who meet Diagnostic and Statistical Manual of Mental
      Disorders, Fourth Edition (DSM-IV) criteria for ADHD
    

Eligibility criteria:

        Inclusion Criteria:

          -  at least 18 years of age

          -  meet Conners' Adult ADHD Diagnostic Interview for DSM-IV™ (CAADID) diagnostic criteria
             for current ADHD as well as meeting criteria for a historical diagnosis of ADHD during
             childhood

          -  have a Clinical Global Impression-ADHD-Severity (CGI-ADHD-S) score of 4 (moderate
             symptoms) or greater

        Exclusion Criteria:

          -  Patients who meet DSM-IV diagnostic criteria for current major depression and also
             patients who have total score of more than 12 on the Hamilton Depression Rating
             Scale-17 items (HAMD-17) at Visit 1 and Visit 2. Patients who have both a current or
             past history of major depression and have received any anti-depression drug therapy
             within 6 months of Visit 1.

          -  Patients who meet DSM-IV diagnostic criteria for have a current anxiety disorder and
             also require anti-anxiety drug therapy except for those taking benzodiazepines
             analogues for anxiety which need to be limited.

          -  Patients who have any history of bipolar disorder (DSM-IV), any history of
             schizophrenia or any history of a psychotic disorder (DSM-IV) will be excluded from
             the study.

          -  Patients who have been diagnosed (DSM-IV) with a pervasive developmental disorder.
Safety And Efficacy Of UK-432,097 In Chronic Obstructive Pulmonary Disease.
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: UK-432,097; Placebo
Intervention description: Formulated as a dry powder, supplied as capsules and administered using an atomizer device. Given as either 150mcg, 450mcg or 1350mcg BID.; Capsules containing 100% lactose administered BID using an atomizer device
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 87.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Dry Powder for Inhalation; Chronic Obstructive Pulmonary Disease; Lung Function testing

Summary:

      Safety and efficacy (measured by spirometry) of UK-432,097 administration will be tested in
      patients with chronic obstructive pulmonary disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a diagnosis, for at least 6 months, of moderate to severe COPD (GOLD)
             and who meet the criteria for Stage II-III disease

          -  Patients must have a smoking history of at least 10 pack-years

          -  Patients must have stable disease for at least 1 month prior to screening.

        Exclusion Criteria:

          -  More than 2 exacerbations of COPD in the preceding year

          -  History of a lower respiratory tract infection or significant disease instability
             during the month proceding screening or during the time between screen and
             randomization.

          -  History or presence of respiratory failure, cor pulmonale or right ventricular failure
Cannabidiol on Reward- and Stress-related Neurocognitive Processes in Individuals With Opioid Use Disorder
Condition: Opioid-use Disorder
MeSH terms: Opioid-Related Disorders; Substance-Related Disorders
Intervention: Cannabidiol 100 MG/ML [Epidiolex]; Placebo
Intervention description: 600mg; Matching placebo
Intervention MeSH terms: Cannabidiol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study is a double-blind, placebo-controlled, cross-over trial.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: This is a double-blind cross-over trial, in which the research staff and participants will be blinded.
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the impact of cannabidiol on reward- and
      stress-related neurocognitive processes among individuals with opioid use disorder on
      buprenorphine or methadone treatment.
    

Eligibility criteria:

        Inclusion Criteria

          -  English speaking

          -  DSM5 diagnosis of opioid use disorder

          -  Receiving buprenorphine or methadone for treatment of opioid use disorder

          -  Agreeable to abstaining from using any cannabis or CBD products for the duration of
             the trial.

        Exclusion Criteria:

          -  Any self-reported use of cannabis or CBD products in the past 30 days

          -  Baseline depression (PHQ9) or anxiety (GAD7) scores of greater than 10

          -  Currently pregnant

          -  Hepatic liver enzymes greater than 3x upper normal limit

          -  Hypersensitivity to cannabinoids or sesame oil (CBD solution comes in sesame oil
             emulsion)

          -  Currently taking any medications with known significant pharmacokinetic interactions
             with CBD
Statin Therapy in Acute Influenza
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Atorvastatin; Placebo
Intervention MeSH terms: Atorvastatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 116.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Influenza (the 'flu') is a common virus infecting approximately 5-20% of the population in
      the United States and causing as many as 500,000 deaths worldwide each year. Currently, there
      are only a few treatments for influenza infection and none of these target inflammation that
      can be caused by the virus. This study will test whether the anti-inflammatory effects of
      statins, a class of drugs most often used to treat high cholesterol, will decrease the
      severity of illness in patients who are infected with influenza by testing markers of
      inflammation in the blood and recording resolution of influenza illness.
    

Eligibility criteria:

        Inclusion Criteria:(all must be present):

          1. Adult patient (age > 18 years)

          2. Positive influenza DFA/RAT test result

          3. <12 hours from positive influenza test result

        Exclusion Criteria:

          1. Prior statin medication use (within 30 days of positive influenza test result)

          2. Comfort measures only designation or anticipated withdrawal of life-support

          3. Atorvastatin specific exclusions:

               1. Documented liver cirrhosis or liver dysfunction (AST or ALT greater than 240)

               2. Known allergy or intolerance to statins

               3. Rhabdomyolysis (CPK elevation > 6x normal)

               4. Patients taking the following medications: cyclosporine, HIV protease inhibitors,
                  hepatitis C protease inhibitor telaprevir, fibric acid derivatives (gemfibrozil),
                  niacin, azole antifungals (itraconazole, ketoconazole) clarithromycin and
                  colchicine

          4. Patients unable to take oral or nasogastric medications or plan for no oral intake as
             part of medical course (eg. emergent surgical intervention)

          5. Known pregnancy or active breastfeeding

          6. Inability to provide written informed consent for any reason
Evaluate the Efficacy and Safety of Pasireotide LAR (Long Acting Release) on the Treatment of Patients With Clinically Non-Functioning Pituitary Adenoma.
Condition: Non-functioning Pituitary Adenoma
MeSH terms: Adenoma; Pituitary Neoplasms; Pituitary Diseases
Intervention: Pasireotide LAR
Intervention description: 20 and 40 mg of powder in vials and 2 mL of vehicle in ampoules (for reconstitution) administered as a depot intragluteal IM (intramuscular) injection
Intervention MeSH terms: Pasireotide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-functioning pituitary adenoma,; pasireotide LAR,; tumor volume

Summary:

      This study assessed pasireotide LAR efficacy on patients with non-functioning pituitary
      adenomas concerning tumor growth.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-functioning pituitary adenoma ≥ 1cm, patients without any previous treatment for
             the tumor

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

        Exclusion Criteria:

          -  Patients who required a surgical intervention for relief of any sign or symptom
             associated with tumor compression

          -  Previous pituitary surgery

          -  Previous medical treatment for pituitary tumor

          -  Patients who had received pituitary irradiation within 10 years prior to randomization

          -  Prolactin (PRL) levels > 100 ng/mL. PRL evaluation should have been performed with
             diluted samples to ensure "hook effect." was avoided

          -  Patients who presented prolactinomas, acromegaly or Cushing's disease

          -  Patients with compression of the optic chiasm causing acute clinically significant
             visual field defects
Safety, Tolerability, and Pharmacokinetics of Fidaxomicin in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)
Condition: Clostridium Difficile-associated Diarrhea
MeSH terms: Clostridium Infections; Diarrhea
Intervention: fidaxomicin
Intervention description: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.
6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days.
Intervention MeSH terms: Fidaxomicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 6 Months
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Clostridium difficile-associated diarrhea; CDAD; Pediatric

Summary:

      The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of
      fidaxomicin in pediatric subjects with Clostridium difficile-associated diarrhea (CDAD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female 6 months to 17 years 11 months of age, inclusive;

          -  Female subjects of childbearing potential must use adequate contraception

          -  Diagnosed with CDAD

        Exclusion Criteria:

          -  Concurrent use of oral vancomycin or metronidazole or any other effective treatments
             for CDAD

          -  Fulminant colitis

          -  History of inflammatory bowel disease

          -  Pregnant or breast-feeding

          -  Need for concurrent use of some P-glycoprotein inhibitors during therapy
Oral Omadacycline vs. Oral Nitrofurantoin for the Treatment of Cystitis
Condition: Uncomplicated Urinary Tract Infection; Cystitis
MeSH terms: Urinary Tract Infections; Cystitis
Intervention: Omadacycline tablets; Nitrofurantoin capsules
Intervention description: Oral Omadacycline; Oral Nitrofurantoin
Intervention MeSH terms: Nitrofurantoin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 225.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of oral omadacycline as
      compared to oral nitrofurantoin in the treatment of female adults with cystitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female participants, age 18 or older who have signed the informed consent form

          -  Must have a qualifying uncomplicated urinary tract infection

          -  Participants must not be pregnant at the time of enrollment

          -  Must agree to a reliable method of birth control during the study and for 30 days
             following the last dose of study drug

        Exclusion Criteria:

          -  Males

          -  Evidence of complicated urinary tract infection (UTI), upper UTI, vaginitis, or
             sexually transmitted infection

          -  Evidence of significant immunological disease

          -  Has received an investigational drug within the past 30 days

          -  Participants who are pregnant or nursing
Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Previously Untreated Marginal Zone Lymphoma
Condition: Marginal Zone Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell, Marginal Zone
Intervention: Rituximab; Ibritumomab Tiuxetan
Intervention description: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³; IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:
0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³
Intervention MeSH terms: Rituximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: Marginal Zone Lymphoma; Non-gastric extranodal Marginal Zone Lymphoma; Splenic Marginal Zone Lymphoma; Nodal Marginal Zone Lymphoma; Gastric Marginal Zone Lymphoma; MZL; Non-gastric extranodal MZL; Splenic MZL; Nodal MZL; Gastric MZL

Summary:

      Zevalin may be an effective therapy for newly diagnosed marginal zone lymphoma (MZL).
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥ 18 years old with previously untreated, histologically confirmed Marginal Zone
             Lymphoma (non-gastric extranodal MZL, splenic MZL and nodal MZL) or gastric MZL that
             did not respond to antibiotic therapy given up to 6 months prior to enrollment, but
             not less than 2 months)

          -  Measurable and evaluable disease

          -  All stages are eligible

          -  Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
             (Appendix B)

          -  Willing and able to provide written informed consent

          -  Women of childbearing potential must have a negative pregnancy test at study entry and
             must agree to use effective contraception while on treatment and for 6 months after
             treatment

          -  Life expectancy of at least 6 months

        Exclusion Criteria:

          -  Prior chemotherapy, radiation therapy, immunotherapy, systemic corticosteroids, or
             systemic biologic anticancer therapy before beginning study treatment.

          -  ≥ 25% lymphoma bone marrow involvement

          -  Platelet count < 100,000 cells/mm³

          -  Neutrophil count < 1,500 cells/mm³

          -  Known history of HIV infection

          -  Pregnant or lactating (pregnancy test is required for all female patients of
             childbearing potential)

          -  Woman of childbearing potential or sexually active man unwilling to use adequate
             contraceptive protection.

          -  Physical or mental condition that makes patient unable to complete specified follow-up
             assessments