bioihbjkbjnl/mcl2 huggingface dataset:
Oral T7 Oral Testosterone in Man
Condition: Healthy Males; Male Contraceptive
Intervention: First Intervention (7 days); First Washout (7 days); Second Intervention (7 days); Third Intervention (7 days); Second wash-out period
Intervention description: Acyline 300mcg/kg subcutaneous (days 1, 15 & 29) + testosterone undecanoate 200 mg, twice daily orally + finasteride placebo; Washout of 7 days between each of the 3 treatment arms; Acyline 300mcg/kg subcutaneous + testosterone undecanoate 200 mg, twice daily orally + finasteride 0.5mg twice daily, orally; Acyline 300mcg/kg subcutaneous + testosterone undecanoate 200 mg, twice daily orally + finasteride 1mg twice daily, orally; Washout of 7 days between each of the 3 treatment arms
Intervention MeSH terms: Finasteride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: Male
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: 5α-reductase; androgen; dihydrotestosterone (DHT); drug delivery; oestradiol

Summary:

      The purpose of this study is to test how the body absorbs and processes new forms of oral
      testosterone. Information gained during the study may help develop better forms of
      testosterone therapy in the future.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males between 18 and 50 years of age

          -  In good health based on normal screening evaluation (consisting of a medical history,
             physical exam normal serum chemistry, hematology, and baseline hormone levels.

          -  Must agree to not participate in another research drug study

          -  Must agree to not donate blood

          -  Must be willing to comply with the study protocol and procedures

        Exclusion Criteria:

          -  Men in poor general health, with abnormal blood results (clinical laboratory tests or
             hormone values)

          -  A known history of alcohol or drug abuse

          -  Participation in a long-term male contraceptive study within the past month

          -  History of bleeding disorders or current use of anti-coagulants

          -  History of sleep apnea

          -  History of major psychiatric disorder

          -  Body mass index > 37

          -  Infertility

          -  Hematocrit > 55 or < 30

          -  PSA >4
Dexpramipexole Dose-Ranging Biomarker Study in Subjects With Eosinophilic Asthma
Condition: Eosinophilic Asthma; Asthma
MeSH terms: Asthma; Pulmonary Eosinophilia
Intervention: Dexpramipexole; Placebo
Intervention description: dexpramipexole twice daily oral dosing for up to 12 weeks; placebo twice daily oral dosing for up to 12 weeks
Intervention MeSH terms: Pramipexole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Four-arm parallel assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 534.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No
Keywords: Eosinophilic Asthma; Asthma; dexpramipexole

Summary:

      This is a randomized, double-blind, placebo-controlled, parallel-group, dose-ranging,
      multi-center study to evaluate the clinical effects of oral administration of dexpramipexole
      for 12 weeks on peripheral blood eosinophil count in subjects with eosinophilic asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥18 and <75 years of age at the time of consent

          -  Physician diagnosis of asthma for ≥12 months (relative to Baseline) based on Global
             Initiative for Asthma (GINA) 2018 Guidelines

          -  Asthma requiring treatment with, at a minimum, low dose inhaled corticosteroids in
             combination with a long-acting β2 agonist, on a stable dose for at least 1 month
             before Screening

          -  Bronchodilator reversibility, as evidenced by ≥12% and ≥200 mL improvement in FEV1 15
             to 25 minutes following inhalation of albuterol at Screening

          -  Pre-bronchodilator FEV1 ≥40% and <80% of predicted at Screening and Baseline

          -  AEC ≥0.30 x10^9/L at the Screening visit

          -  ACQ-7 ≥1.5 at Screening

          -  Negative pregnancy test at Baseline

          -  Adherence ≥85% with twice-daily placebo taken during the Run-in Period

        Exclusion Criteria:

          -  Treatment for an asthma exacerbation within 8 weeks prior to Baseline visit

          -  Treatment with systemic corticosteroids in the 8 weeks prior to Screening

          -  Treatment with monoclonal antibody therapy, within 5-half-lives prior to Baseline

          -  Treatment with selected drugs known to have a substantial risk of neutropenia

          -  Absolute neutrophil count <2.0x10^9/L at Screening, or any documented history of
             absolute neutrophil count <2.0x10^9/L.

          -  Renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) <60
             mL/min/1.73m^2 at Screening

          -  Clinically significant abnormal laboratory or ECG values

          -  Other medically significant illness

          -  Use of any smoke or inhaled nicotine delivery device within 1 year prior to Screening

          -  Pregnant women or women breastfeeding

          -  Currently taking pramipexole or other dopamine agonists
Study of Sleep-maintenance Activity of 3 Doses of SKP-1041
Condition: Sleep Disorder; Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders
Intervention: placebo; SKP-1041 (experimental formulation of zaleplon)
Intervention description: tablet at bedtime; tablet at bedtime
Intervention MeSH terms: Zaleplon
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 67.0
Sex: All
Minimum age: 21 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: insomnia; middle of the night; sleep maintenance

Summary:

      SKP-1041 is a new formulation of a marketed sleeping agent called zaleplon. Zaleplon is
      currently available as Sonata as well as several generic formulations. Sonata and its
      generics induce sleep soon after ingestion. SKP-1041, however, is a formulation that is
      designed to become active 2-3 hours after ingestion. It is intended for use in people who
      have no trouble falling to sleep but who often awaken in the middle of the night. This trial
      will determine the best dose to prevent those awakenings.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primary insomnia characterized by chronic difficulty maintaining sleep

        Exclusion Criteria:

          -  History of restless legs syndrome, sleep apnea, narcolepsy, or parasomnias;

          -  Any clinically relevant acute or chronic diseases which could interfere with the
             patient's safety during this trial or with this tablet's absorption;

          -  Pregnancy;

          -  History of medication allergies;

          -  Use of medication that might interfere with this study;

          -  Recent travel across more than 3 time zones.
A Study of Herceptin (Trastuzumab) Monotherapy in Patients With Metastatic Urothelial Cancer
Condition: Urinary Tract Cancer
MeSH terms: Urologic Neoplasms
Intervention: trastuzumab
Intervention description: Initial dose of 4 mg/kg i.v on Day 1, followed by weekly doses of 2 mg/kg i.v. beginning on Day 8 and continuing for up to 37 weeks.
Intervention MeSH terms: Trastuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of intravenous Herceptin in patients with
      metastatic urothelial cancer with disease progression during platinum-based chemotherapy. The
      anticipated time on study treatment is until disease progression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients >=18 years of age;

          -  metastatic urothelial cancer;

          -  disease progression during or after 1 prior platinum-based chemotherapy;

          -  measurable disease;

          -  HER2 overexpression (IHC [2+] or [3+]).

        Exclusion Criteria:

          -  concomitant chemotherapy or immunotherapy;

          -  active or uncontrolled infection;

          -  solely CNS metastases;

          -  clinically significant cardiac disease, advanced pulmonary disease or severe dyspnoea;

          -  co-existing malignancies diagnosed within last 5 years, except basal cell cancer or
             cervical cancer in situ.
Chlortalidone and Bumetanide in Advanced Chronic Kidney Disease: HEBE-CKD Trial
Condition: Renal Insufficiency, Chronic
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency
Intervention: Chlorthalidone; Bumetanide
Intervention description: Chlorthalidone; Bumetanide
Intervention MeSH terms: Chlorthalidone; Bumetanide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diuretics; Bumetanide; Chlorthalidone; Chronic Kidney Disease; Volume Overload

Summary:

      This study aims to demonstrate the possible benefit of a treatment based on double diuretic
      in patients with chronic kidney disease and severely impaired glomerular filtration rate.
      This is based on previous observations where the investigators found that volume overload is
      a frequent condition within this population and is strongly linked to an increase in
      morbidity and mortality. The investigators consider that this therapy could be beneficial
      given that most of these patients are treated with loop diuretics, however, with the passage
      of time, adaptive changes in the distal nephron occur that promote a decrease in the
      treatment effect. In this sense, thiazide diuretics at appropriate doses could 'break' the
      resistance, since their mechanism of action antagonizes the resistance mechanism.
      Unfortunately, to this day, this treatment has not been fully evaluated. Particularly in this
      type of population.

      The investigators developed a study proposed as a double blind randomized clinical trial,
      where the population will be divided into two groups. A group will be given the standard
      treatment based on loop diuretic (bumetanide), while the other group will receive the
      intervention (bumetanide plus chlorthalidone). After a 30-day follow-up period, the results
      will be measured.

      With respect to the effectiveness of the treatment, the decrease in volume overload by
      bioimpedance will be measured. While the occurrence of adverse effects during the same
      monitoring period will be observed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  glomerular filtration rate less than 30 ml / min / 1.73m

          -  Without replacement therapy (dialysis or hemodialysis)

          -  Volume overload

          -  At least 100 ml per day of residual diuresis

          -  Use of a loop diuretic for at least one month

        Exclusion Criteria:

          -  Allergies known to diuretics

          -  Patients with severe infections

          -  Patients with hemodynamic instability

          -  Amputees

          -  Patients with cognitive impairment

          -  Patients with acute renal failure

          -  Patients with graft loss
Antihistamines in Eosinophilic Esophagitis
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Intervention: Famotidine; Loratadine; Placebo
Intervention description: 40 mg tab twice daily by mouth for 12 week duration; 10 mg tab once daily by mouth for 12 week duration; Contains no active ingredient
Intervention MeSH terms: Loratadine; Famotidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Researchers are assessing the safety and effectiveness of antihistamines in the treatment of
      eosinophilic esophagitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients over the age of 18, male and female.

          -  Patients who carry the diagnosis of Eosinophilic Esophagitis (EoE) based on esophageal
             biopsies obtained within 6 months prior to enrollment (>15 eosinophils per hpf on at
             least 2 esophageal levels)

          -  Subjects must be able to give appropriate informed consent

        Exclusion Criteria:

          -  Not willing or able to sign consent.

          -  Patients who have used topical or systemic corticosteroid therapy for any reason in
             the previous 6 weeks.

          -  Patients who have been treated with acid-suppressing medications (PPI or H2 receptor
             antagonists) in the previous 6 weeks.

          -  Patients on immunosuppressive or immunomodulating medications in the previous 6 weeks.

          -  Patients with known allergies or hypersensitivity to anti-histamines.

          -  Patients who have contraindications to the procurement of esophageal biopsies
             including patients who have known bleeding disorders, a history of bleeding diathesis,
             or who are currently using warfarin or clopidogrel.

          -  Patients who have a contraindication to the performance of an
             esophagogastroduodenoscopy (EGD) including previous cardiopulmonary arrest during an
             endoscopic procedure.

          -  Patients who are pregnant.
Safety and Efficacy of IDP-118 Lotion to Ultravate® in the Treatment of Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: IDP-118 Vehicle Lotion; IDP-118 Vehicle Cream; IDP-118 Lotion; Ultravate Cream
Intervention description: Vehicle; Vehicle; Lotion; Cream
Intervention MeSH terms: Clobetasol; Halobetasol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 154.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Safety and Efficacy of IDP-118 Lotion to Ultravate® Cream, in the Treatment of Plaque
      Psoriasis
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male or female, of any race, at least 18 years of age (inclusive).

          -  Freely provides both verbal and written informed consent.

          -  Has an area of plaque psoriasis appropriate for topical treatment that covers a BSA
             (Body Surface Area) of at least 3%, but no more than 12%. The face, scalp, palms,
             soles, axillae, and intertriginous areas are to be excluded in this calculation.

          -  Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet
             radiation (natural and artificial) for the duration of the study.

          -  Has a clinical diagnosis of psoriasis at the Baseline visit with an IGA (Investigators
             Global Assessment) score of 3 or 4. (The face, scalp, palms, soles, axillae, and
             intertriginous areas are to be excluded in this assessment, if psoriasis is present.)

          -  If female and of childbearing potential, must have a negative urine and serum
             pregnancy test at the Screening visit and negative urine pregnancy at Baseline visit
             prior to randomization.

          -  Subject is willing to comply with study instructions and return to the clinic for
             required visits.

        Key Exclusion Criteria:

          -  Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular
             psoriasis, as determined by the investigator.

          -  Presents with psoriasis that was treated with prescription medication and failed to
             respond to treatment, even partially or temporarily, as determined by the
             investigator.

          -  Presents with any concurrent skin condition that could interfere with the evaluation
             of the treatment areas, as determined by the investigator.

          -  Is pregnant, nursing an infant, or planning a pregnancy during the study period.

          -  Has received treatment with any investigational drug or device within 60 days or 5
             drug half-lives (whichever is longer) prior to the Baseline visit, or is concurrently
             participating in another clinical study with an investigational drug or device.
Open-Label, Safety and Tolerability Extension Study of KNS-760704 in Amyotrophic Lateral Sclerosis (ALS) (CL211)
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Intervention: KNS-760704
Intervention description: 150 mg Q12H KNS-760704 given orally (300 mg total daily dose)
Intervention MeSH terms: Pramipexole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: All
Minimum age: 21 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: ALS; Amyotrophic Lateral Sclerosis; Lou Gehrig; Lou Gehrig's; Lou Gehrig's disease; Motor Neuron Disease; Nervous System Diseases; KNS-760704; RTPB

Summary:

      This is an open-label, multi-center study designed to extend the evaluation of the safety,
      tolerability, and clinical effects of oral administration of KNS-760704 in patients with ALS.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient has provided signed informed consent for this trial before the commencement of
             any study-related procedure

          2. Patient is actively participating in Knopp Protocol KNS-760704-CL201 and has completed
             the Part 2 Week 28 visit in that study or patient is actively receiving RTPB under
             Research IND #60,948

        Exclusion Criteria:

          1. Patient did not participate in Knopp Protocol KNS-760704-CL201 or patient did not
             receive RTPB under Research IND #60,948.

          2. Patient discontinued from KNS-760704-CL201 for any reason other than enrollment into
             this study (applies to patients enrolled in KNS-760704-CL201 only)

          3. Patient was not taking RTPB under Research IND #60,948 prior to April 30, 2009
             (applies to patients enrolled under Research IND #60,948 only)
Evaluation of the Efficacy of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease
Condition: Dry Eye Disease
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: OC-01 (varenicline) nasal spray; Placebo (vehicle) nasal spray
Intervention description: OC-01 (varenicline) nasal spray; Placebo
Intervention MeSH terms: Varenicline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 182.0
Sex: All
Minimum age: 22 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the safety and effectiveness of OC-01 Nasal Spray
      as compared to placebo on signs and symptoms of dry eye disease
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have used and/or desired to use an artificial tear substitute for dry eye symptoms
             within 6 months prior to Visit 1

        Exclusion Criteria:

          -  Have had any intraocular surgery (such as cataract surgery), extraocular surgery (such
             as blepharoplasty) in either eye within three months or refractive surgery within
             twelve months of Visit 1

          -  Have a history or presence of any ocular disorder or condition in either eye that
             would, in the opinion of the Investigator, likely interfere with the interpretation of
             the study results or participant safety such as significant corneal or conjunctival
             scarring; pterygium or nodular pinguecula; current ocular infection, conjunctivitis,
             or inflammation not associated with dry eye; anterior (epithelial) basement membrane
             corneal dystrophy or other clinically significant corneal dystrophy or degeneration;
             ocular herpetic infection; evidence of keratoconus; etc. Blepharitis not requiring
             treatment and mild meibomian gland disease that are typically associated with DED are
             allowed.

          -  Have a systemic condition or disease not stabilized or judged by the Investigator to
             be incompatible with participation in the study or with the lengthier assessments
             required by the study (e.g., current systemic infection, uncontrolled autoimmune
             disease, uncontrolled immunodeficiency disease, history of myocardial infarction or
             heart disease, etc.)

          -  Have a known hypersensitivity to any of the procedural agents or study drug components

          -  Have any condition or history that, in the opinion of the investigator, may interfere
             with study compliance, outcome measures, safety parameters, and/or the general medical
             condition of the subject
A Phase 2b Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP)
Condition: Palmoplantar Pustulosis
MeSH terms: Psoriasis
Intervention: RIST4721; Placebo
Intervention description: RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets; Matching placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Double-blind
Enrollment: 79.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No

Summary:

      A 12-week Randomized, Double-blind, Placebo-controlled, Dose Ranging Phase 2 Study to
      Evaluate the Efficacy and Safety of RIST4721 in Subjects with Palmoplantar Pustulosis
      followed by an Open-label Extension Phase.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 6 months history of moderate or severe PPP, as defined by PPPASI ≥12 and
             PPPGA ≥3 at screening

          -  Males and females must be willing to use birth control as indicated

        Exclusion Criteria:

          -  Moderate to severe psoriasis covering ≥10% of total body surface area (BSA) at
             screening

          -  Breastfeeding or pregnant

          -  Known immunodeficiency or subject is immunocompromised

          -  Active/latent infection with HBV, HCV, HIV, SARS-CoV-2 or TB

          -  Any topical medications for PPP excluding emollients within two weeks of randomization
             and systemic therapies (including phototherapy) within 4 weeks of randomization