bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacodynamic Study of AZD1722 in End-stage Renal Disease Patients on Hemodialysis
Condition: End Stage Renal Disease; Chronic Kidney Disease Stage 5; ESRD
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic
Intervention: AZD1722 (in-patient); Placebo (in-patient); AZD1722 (out-patient); Placebo
Intervention description: doses between 5 and 60 mg BID may be administered based on tolerability in a CPU setting; Placebo, size and color matched to experimental drug administered in a CPU; doses between 5 and 45 mg BID; Placebo, size and color matched to experimental drug
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 88.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Hemodialysis

Summary:

      The purpose of this study is to determine if the study drug is safe, tolerable and active in
      reducing fluid overload/weight gain between dialysis sessions for patients with End Stage
      Renal Disease on Hemodialysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females aged 18 to 80 years, inclusive;

          -  Body mass index between 18 and 45 kg/m2, inclusive;

          -  Ambulatory (≥ 6 months) maintenance hemodialysis;

          -  Stable dialysis treatment regimen 3x/week for ≥ 2 months prior to screening visit.

        Exclusion Criteria:

          -  Currently taking diuretic medication;

          -  Has a urine production of ≥ 200 ml/day (based on a 24-hour measurement starting on Day
             -1 and completed prior to randomization);

          -  Predialysis systolic BP >200 mmHg or diastolic BP >110 mmHg on two successive
             occasions during the 2-week run-in period;

          -  Predialysis SBP < 110 mmHg on two successive occasions during the 2-week run-in period
The Effects of Aldara as an Adjunct to Laser Treatment
Condition: Port Wine Stains
MeSH terms: Hemangioma, Capillary; Port-Wine Stain
Intervention: Imiquimod; non-medicated petroleum cream
Intervention description: commercially available topical antiviral drug; Over the counter topical cream used to aid the healing process in skin lesions
Intervention MeSH terms: Imiquimod
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 7.0
Sex: All
Minimum age: 2 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: laser; pediatric; skin pigmentation

Summary:

      The primary objective is to determine the effects of Aldara on the cosmetic outcome of laser
      treatment of vascular malformations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patient between the ages of 2 and 60 years with a vascular malformation
             that is seeking cosmetic treatment.

          -  All races will be included as well as male and female.

          -  Clinical data on the usage of Aldara below the age of 2 years is limited and therefore
             all patients in the study will have to be at least 2 years of age.

          -  The majority of port wine stains are initially treated during childhood

          -  In order to determine the effectiveness of Aldara as an adjunct to laser therapy of
             Port Wine Stains, some of the patients in the study need to have lesions that have not
             undergone previous treatment.

        Exclusion Criteria:

          -  Patients under the age of 2 or over the age of 60.

          -  Patients that have serious medical problems that would put them at risk of the
             anesthesia.

          -  Patients that have sensitivity reactions to the ingredients in the product including
             imiquimod, isostearic acid, cetyl alcohol, stearyl alcohol, white petrolatum,
             polysorbate 60, sorbitan monostearate, glycerin, xanthan gum, purified water, benzyl
             alcohol, methylparaben, and propylparaben.

          -  Patients who are pregnant or have significant immunodeficiency or autoimmune diseases.
Anti-angiOpoeitin 2 Plus Anti-vascular eNdothelial Growth Factor as a therapY for Neovascular Age Related Macular Degeneration: Evaluation of a fiXed Combination Intravitreal Injection
Condition: Neovascular Age-Related Macular Degeneration
MeSH terms: Macular Degeneration; Wet Macular Degeneration
Intervention: REGN910-3; Intravitreal Aflibercept Injection (IAI)
Intervention MeSH terms: Aflibercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 365.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      The primary objective of the study is to compare the efficacy of intravitreal
      (IVT)-administered REGN910-3 compared to intravitreal aflibercept injection (IAI).
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Men or women ≥50 years of age with active subfoveal CNV secondary to AMD, including
             juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye as
             assessed by a central reading center

          2. BCVA ETDRS letter score of 73 to 24 (Snellen equivalent of 20/40 to 20/320) in the
             study eye.

          3. Willing and able to comply with clinic visits and study-related procedures.

          4. Provide signed informed consent.

        Key Exclusion Criteria:

          1. Evidence of CNV due to any cause other than AMD in either eye

          2. Prior IVT anti-VEGF in the study eye

          3. Evidence of DME or diabetic retinopathy (defined as more than 1 microaneurysm) in
             either eye in diabetic patients

          4. Any history of macular hole of stage 2 and above in the study eye
A Phase 2 Open-Label Study of the Efficacy and Safety of ABT-199 (GDC-0199) in Chronic Lymphocytic Leukemia (CLL) Subjects With Relapse or Refractory to B-Cell Receptor Signaling Pathway Inhibitor Therapy
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Venetoclax
Intervention description: Each dose of venetoclax was to be taken with approximately 240 mL of water within 30 minutes after the completion of breakfast or the participant's first meal of the day.
Intervention MeSH terms: Venetoclax
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 127.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Oncology; Chronic Lymphocytic Leukemia; Cancer of the blood and bone marrow

Summary:

      This was an open-label, non-randomized, multicenter, Phase 2 study evaluating the efficacy
      and safety of ABT-199 in 127 participants with relapsed or refractory chronic lymphocytic
      leukemia (CLL) after B-cell receptor signaling pathway inhibitors (BCR PI) treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant must have a diagnosis of chronic lymphocytic leukemia (CLL) that meets
             2008 Modified International Workshop on Chronic Lymphocytic Leukemia National Cancer
             Institute-Working Group (IWCLL NCI-WG) criteria

          -  Participant has relapsed/refractory disease with an indication for treatment

          -  Participant has refractory disease or developed recurrence after therapy with a B-cell
             receptor pathway inhibitor (BCR PI)

          -  Participant must have an Eastern Cooperative Oncology Group performance score of ≤ 2

          -  Participant must have adequate bone marrow function at Screening

          -  Participant must have adequate coagulation profile, renal, and hepatic function, per
             laboratory reference range at Screening

        Exclusion Criteria:

          -  Participant has undergone an allogeneic stem cell transplant within the past year

          -  Participant has developed Richter's transformation confirmed by biopsy

          -  Participant has active and uncontrolled autoimmune cytopenia

          -  Participant has malabsorption syndrome or other condition that precludes enteral route
             of administration

          -  Participant is human immunodeficiency virus (HIV) positive or has chronic hepatitis B
             or hepatitis C virus requiring treatment

          -  Participant has known contraindication or allergy to both xanthine oxidase inhibitors
             and rasburicase
Microscopic Fluorescence-guided Vestibular Schwannoma Resection Using Fluorescein Sodium and YELLOW 560
Condition: Vestibular Schwannoma
MeSH terms: Neurilemmoma; Neuroma, Acoustic
Intervention: Fluorescein Sodium; YELLOW560 filter
Intervention description: Intravenous administration 1 mg/kg initial dosing if insufficient additional doses of 1 mg/kg may be administered.; Integrated fluorescence module serves to make fluorescent areas visible to assist in visualizing tumor during the resection.
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Head and Neck Paraganglioma; Head and Neck Schwannoma

Summary:

      The purpose of this study is to see if there is benefit to using an IV contrast called
      AK-Fluor® and a microscope filter called YELLOW560 when surgically removing a vestibular
      schwannoma, Meningioma, Head and Neck Paraganglioma, or Head and Neck Schwannoma.
    

Eligibility criteria:

        Inclusion Criteria

          -  Patient with a suspected VS

          -  Recurrent VS with prior microsurgical resection or radiation therapy

          -  Clinical indication for microsurgical resection

        Exclusion Criteria

          -  History of allergy to FS

          -  History of renal failure

          -  Pregnant women

          -  Those with inability to give informed consent

          -  Prisoners and inmates
An Open-label Safety Study of Pimavanserin in Parkinson's Disease Patients
Condition: Parkinson's Disease Psychosis
MeSH terms: Parkinson Disease
Intervention: pimavanserin tartrate (ACP-103)
Intervention description: Tablets taken once daily by mouth at 20, 40, or 60 mg doses
Intervention MeSH terms: Pimavanserin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Healthy volunteers: No

Summary:

      This is an open-label extension study to assess the long-term safety and tolerability of
      pimavanserin (ACP-103) in subjects with Parkinson's Disease Psychosis (PDP).
    

Eligibility criteria:

        Inclusion Criteria-

          -  Patients of any age, male or female with a clinical diagnosis of idiopathic
             Parkinson's disease, who participated in a previous (Phase II) clinical trial that
             evaluated pimavanserin

          -  Patients who may, in the opinion of the treating physician, benefit from continued
             therapy with pimavanserin

          -  Patient is willing and able to provide consent

        Exclusion Criteria-

          -  Female patient of childbearing potential

          -  Patient has a clinically significant concurrent medical illness

          -  Patient is judged by the treating physician to be inappropriate for the study.
The Role of 68Ga-PSMA-11 PET (Prostate Specific Membrane Antigen) in Surgery Guidance in Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: 68Ga-PSMA-11 PET Scan
Intervention description: Patients will undergo injection of 68Ga-PSMA-11 at the time of their pre treatment PSMA PET scan and followed until 12 months post surgery.
Intervention MeSH terms: Gallium 68 PSMA-11
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Intervention model description: 68Ga-PSMA-11 PET will be performed and we will study how the knowledge of the results informs treatment decisions versus the treatment decisions with only MRI knowledge.
Masking: None (Open Label)
Masking description: Two separate radiologists (one from Nuclear Medicine and one from MRI) will read images in a blinded fashion and provide their findings for the surgeons to use in treatment planning.
Enrollment: 51.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Obtain PSMA-PET imaging preoperatively and calculate performance for predicting
      extra-prostatic extension based on whole-mount pathology (gold standard).

      Quantify the frequency of proper treatment changes directed by PSMA-PET, focusing on
      appropriate preservation of surrounding structures important for genito-urinary function
      including: 1) Bladder neck, 2) Nerve bundles, 3) Urethral Sphincter (Figure 4).

      Directly compare PSMA-PET performance for predicting extra-prostatic extension to
      standard-of-care assessments.

      Assess quality of life changes from preoperative baseline.
    

Eligibility criteria:

        Inclusion Criteria:

          -  1. Men diagnosed with clinically significant prostate cancer who are scheduled or
             scheduling for prostatectomy 2. Prostate pathology results consistent with:

               1. > 3 cores of Gleason 3+4 or

               2. NCCN unfavorable intermediate risk or

               3. NCCN high-risk or

               4. NCCN very-high risk 3. Scheduled for standard of care MRI or has recently
                  completed standard of care MRI (within 6 months).

        Willing and able to lie still for approximately 50 minutes in an enclosed space for the
        PET/CT and MRI

        Exclusion Criteria:

          -  1. Participation in another investigational trial involving research exposure to
             ionizing radiation concurrently or within 30 days.

             2. Does not meet safety criteria for MRI scan (e.g. metal implant that could affect
             prostate imaging).

             3. Significant acute or chronic medical, neurologic, or illness in the subject that,
             in the judgment of the Principal Investigator, could compromise subject safety, limit
             the ability to complete the study, and/or compromise the objectives of the study.
Study to Evaluate the Effects of BMS-813160 on Protein Loss in the Urine of Subjects With Type 2 Diabetes and Diabetic Kidney Disease
Condition: Diabetic Kidney Disease
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Intervention: BMS-813160; Placebo matching with BMS-813160
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 319.0
Sex: All
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether BMS-813160 will reduce the amount of
      protein loss in the urine of subjects with type 2 diabetes and diabetic kidney disease
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Clinical diagnosis of type 2 diabetes mellitus with macroalbuminuria (UACR between 200
             and 3500 mg/g)

          -  Background angiotensin converting enzyme inhibitor (ACEI) or angiotensin-receptor
             blocker (ARB) therapy

        Exclusion Criteria:

          -  Clinical diagnosis of type 1 diabetes

          -  Unstable cardiovascular, metabolic, or other chronic disease status

          -  Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2

          -  High risk of infection or immune compromise

          -  Clinically significant ECG conduction abnormalities

          -  Drugs with significant potential to affect BMS-813160 exposure
Comparing Mouth Rinses (and Chewing Gum) in Regard to Streptococcus Mutans Reduction
Condition: Dental Caries
MeSH terms: Dental Caries
Intervention: Chlorhexidine gluconate (0.12%); Sodium Fluoride (0.05%); Paraffin wax chewing gum (sugar-free); Deionized water
Intervention description: 30 second oral rinse of 10mL of solution; 30 second oral rinse of 10mL of solution; Approximately two minutes of chew time; 30 second oral rinse of 10mL of solution
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate; Listerine; Fluorides; Sodium Fluoride
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 6 Years
Maximum age: 12 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Streptococcus Mutans; Saliva

Summary:

      This study compared four mouth rinses/chews for their ability to reduce Streptococcus Mutans
      after usage. The four that were compared were chlorhexidine gluconate (0.12%), sodium
      fluoride (0.05%), paraffin wax chewing gum (sugar free), and deionized water. The paraffin
      wax chewing gum replaced the originally planned coconut oil and served as a placebo
      comparator.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients presenting to the dental clinic for routine dental treatment (including
             recall exams, new patient exams, and operative appointments) who are American Society
             of Anesthesia (ASA) class I or II

          -  Cooperative patients classified as 3 or 4 according to the Frankl Behavioral Rating
             Scale,

          -  No known allergies or sensitivities to products or ingredients being tested

          -  Had untreated cavities

          -  Nothing to eat/drink for 1 hour prior to dental appointment

        Exclusion Criteria:

          -  Patients who are ASA class III, IV, V or VI

          -  Known allergies or sensitivities to any of the mouth rinses or any of the ingredients
             in the mouth rinses to be tested

          -  Non-English speaking parent/participant

          -  Patient presenting to the clinic as a walk in or emergency appointment

          -  Patient experiencing any pain or sensitivity

          -  Precooperative or uncooperative behavior or behavior classified as 1 or 2 according to
             the Frankl Behavioral Rating Scale
Gabapentin for Bipolar & Cannabis Use Disorders
Condition: Bipolar I Disorder; Bipolar II Disorder; Cannabis Use Disorder; Substance Use Disorders
MeSH terms: Substance-Related Disorders; Marijuana Abuse
Intervention: Gabapentin; Placebo Oral Capsule
Intervention description: 5 day trial of gabapentin with titration to 1,200mg; 5 day trial of matched placebo
Intervention MeSH terms: Gabapentin
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The proposed 2-week, double-blind, crossover, proof of concept study aims to measure and
      manipulate core neurochemical (i.e., dysregulated brain GABA/glutamate homeostasis) and
      neurobehavioral (i.e., elevated impulsivity) dysfunctions characteristic of individuals with
      cannabis use disorder (CUD) and Bipolar Disorder (BD), using a medication that has been shown
      to increase cortical GABA (i.e., gabapentin) levels in past research, and to evaluate
      medication-related changes in response inhibition (go no-go) and cannabis cue reactivity
      functional Magnetic Resonance Imaging tasks, as well as cannabis use, mood symptoms
      (including anxiety and sleep), and impulsivity in individuals with CUD+BD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets DSM-V criteria for Bipolar Disorder

          -  Meets DSM-V criteria for Cannabis Use Disorder

          -  Using at least one mood stabilizing medication

        Exclusion Criteria:

          -  Serious medical or non-inclusionary psychiatric disease

          -  Concomitant use of benzodiazepine medications or any medications hazardous if taken
             with gabapentin

          -  History of clinically significant brain injury

          -  Presence of non-MRI safe material, or clinically significant claustrophobia.
Study of BCX7353 as a Treatment for Attacks of Hereditary Angioedema
Condition: Hereditary Angioedema (HAE)
MeSH terms: Angioedema; Angioedemas, Hereditary
Intervention: BCX7353; Placebo
Intervention description: oral liquid formulation; oral liquid formulation to match BCX7353
Intervention MeSH terms: Berotralstat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: HAE; hereditary angioedema; kallikrein inhibitor; plasma kallikrein

Summary:

      This 3-part study will evaluate the efficacy and safety of an oral kallikrein inhibitor,
      BCX7353, in the treatment angioedema attacks in subjects with Type I or II hereditary
      angioedema (HAE). In each study part, subjects will treat 3 attacks with BCX7353 (2 attacks)
      or placebo (1 attack), in a randomly allocated order. In Part 1, the dose of 750mg will be
      assessed relative to placebo in up to 36 patients. If this is shown to be effective, then a
      further 12 patients will be enrolled at a 500mg dose (Part 1), followed by a further 12 (if
      efficacy still shown) at a dose of 250mg (Part 3) to determine the minimum effective dose of
      BCX7353 compared to placebo for treating HAE attacks. Efficacy will be determined by subject
      diary entries completed at pre-defined times post-dose.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Able to provide written, informed consent.

          2. A clinical diagnosis of hereditary angioedema Type 1 or Type 2 as documented at any
             time in the medical records or at the screening visit.

          3. Access to and ability to use standard of care acute attack treatment for attacks of
             HAE.

          4. Sexually active women of child-bearing potential and sexually active men must utilize
             effective contraception.

        Exclusion Criteria:

          1. Women who are pregnant or breast-feeding.

          2. Any clinical condition or medical history that would interfere with the subject's
             safety or ability to participate in the study.

          3. Use of C1INH, androgens or tranexamic acid for prophylaxis of HAE attacks.

          4. History of or current alcohol or drug abuse.

          5. Infection with hepatitis B, hepatitis C or HIV.

          6. Participation in any other investigational drug study currently or within the last 30
             days.

          7. Positive drugs of abuse screen (unless as used as medical treatment, e.g., with a
             prescription).

          8. An immediate family relationship to either Sponsor employees, the Investigator or
             employees of the study site.