bioihbjkbjnl/mcl2 huggingface dataset:
GB001 in Adult Participants With Chronic Rhinosinusitis
Condition: Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP); Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
MeSH terms: Sinusitis; Nasal Polyps; Polyps
Intervention: GB001; Placebo
Intervention description: film-coated oral tablet; film-coated oral tablet
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 97.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: GB001; Gossamer Bio; Gossamer; Nasal Polyposis; CRSwNP; CRSsNP

Summary:

      A Phase 2a, randomized, double-blind, placebo-controlled, multi-center study to evaluate the
      efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of GB001 compared with
      placebo over 16 weeks of treatment in patients with chronic rhinosinusitis with or without
      nasal polyposis (NP).
    

Eligibility criteria:

        Inclusion Criteria:

          -  A diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP) or chronic
             rhinosinusitis without nasal polyps (CRSsNP) by a physician at least 12 weeks before
             Screening Visit

          -  Treated with stable intranasal corticosteroid (INCS) for at least 2 months prior to
             Screening Visit

          -  Presence of at least 2 nasal symptoms: nasal blockage/ obstruction/congestion or nasal
             discharge or facial pain/pressure or reduction/loss of smell

          -  Women of childbearing potential must use an acceptable method of contraception

        Exclusion Criteria:

          -  Sino-Nasal Outcome Test-22 (SNOT-22) score < 20 at screening

          -  Asthma or chronic obstructive pulmonary disease (COPD) patients that are current
             smokers

          -  Use of other investigational drugs within 30 days, or within 5 half-lives, whichever
             is longer, prior to Screening Visit

          -  Pregnant or breastfeeding

          -  Pre-existing clinically important co-morbidities

          -  Regular use of systemic corticosteroids or immunosuppressive treatments

        Other protocol-defined inclusion/exclusion criteria will apply.
Feasibility of an Integrated Patient Care (IPC) System Using Daily Filling Pressures
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: Diuretics
Intervention description: Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.
Intervention MeSH terms: Diuretics
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Heart failure; Cardiac filling pressure

Summary:

      This chronic, prospective, non-randomized feasibility study is designed to evaluate the
      Integrated Patient Care (IPC) concept in subjects who already have either a Medtronic
      Chronicle Implantable Hemodynamic Monitor (IHM) or Chronicle Implantable Cardioverter
      Defibrillator (ICD) device implanted, and are currently enrolled in the Chronicle Offers
      Management to Patients with Advanced Signs & Symptoms of Heart Failure (COMPASS-HF) Extension
      Phase Study (IDE # G020304). The purpose of the study is to use daily cardiac filling
      pressures from the Chronicle device to provide timely medication adjustments (diuretics) to
      subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients implanted with a Chronicle IHM device (Model 9520, Model 9520B) or Chronicle
             ICD device (Model 7286)

          -  Patients who have been prescribed daily diuretic therapy for the management of heart
             failure

          -  Patients currently participating in the COMPASS-HF Extension Phase Study (IDE
             #G020304)

          -  Patients willing and able to give informed consent

        Exclusion Criteria:

          -  Patients with non-physiologic Right Ventricular (RV) pressure values

          -  Patients who have diuretic resistance

          -  Patients who have an estimated Glomerular Filtration Rate(eGFR) <30 ml/min (recorded
             within the last six months)

          -  Patients who have a Chronicle IHM device (Model 9520) that was implanted as part of
             the Pulmonary Arterial Hypertension (PAH) Pilot Study (IDE #G020303)

          -  Patients who do not have the ability to actively participate in the management of
             their own heart failure care (determine by physician discretion)(e.g. patient does not
             have ability to operate study equipment, patient does not have a history of compliance
             to sending CareLink transmissions)

          -  Patients who have a reasonable probability of needing a device replacement during the
             study (approximately two months)

          -  Patients enrolled or planning to participate in a concurrent drug and/or device study
             during the course of this clinical trial

          -  Patient who are pregnant (all females of child-bearing potential must have a negative
             pregnancy test within 1 week of enrollment)
Pre to Postoperative Smoking Cessation
Condition: Cigarette Smoking; Obesity
Intervention: Varenicline; Contingency Management; Behavioral Counseling
Intervention description: Varenicline will be administered as clinically indicated and will begin approximately 4-6 weeks prior to surgery. All participants will receive a 1-week dose induction period before transitioning to a full maintenance dose.; Contingency Management payments will begin on the target quit date (week 2) and will be in place for 5 weeks or until surgery (whichever is sooner). Participants will receive monetary incentives for biochemical evidence of smoking abstinence.; All participants will complete a 3-session behavioral counseling intervention with a trained member of our study staff during 3 of the pre-surgical study visits. This brief counseling intervention provides participants with information about the experience of quitting smoking, including a benefits/disadvantage analysis, functional analysis of craving/risk periods, and skills-building exercises to prevent lapse and relapse.
Intervention MeSH terms: Varenicline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      The study will evaluate the feasibility of integrating an intensive pre- post-surgical
      smoking cessation intervention into a hospital setting, and assess measures of postsurgical
      recovery as a function of smoking cessation status.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Smoker who has surgery scheduled 5-10 weeks in advance

        Exclusion Criteria:

          -  being contraindicated for varenicline use

          -  evidence of psychiatric instability

          -  being unwilling/unable to adhere to the study schedule

          -  be unwilling to provide study access to medical records

          -  being otherwise judged by the study team to be inappropriate for study participation
A Study of LY3127804 in Participants With COVID-19
Condition: COVID-19; Pneumonia
MeSH terms: COVID-19; Pneumonia
Intervention: LY3127804; Placebo
Intervention description: Administered IV; Administered IV
Intervention MeSH terms: Zansecimab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 95.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Corona Virus Disease 19 (COVID-19); 2019 Novel Coronavirus (2019 n-COV); Severe Acute Respiratory Syndrome (SARS); Pulmonary Disease; SARS-CoV-2

Summary:

      A randomized, double-blind, placebo-controlled, clinical trial of LY3127804 in participants
      who are hospitalized with pneumonia and presumed or confirmed COVID-19.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are hospitalized with pneumonia, and presumed or confirmed COVID-19

          -  Are able and willing to give signed informed consent (legally authorized
             representative can provide informed consent if needed)

        Exclusion Criteria:

          -  Female participants must not be pregnant and/or lactating

          -  Have Acute Respiratory Distress Syndrome (ARDS) or will require immediate intermittent
             mandatory ventilation (IMV), or are ineligible for IMV

          -  Have any concurrent serious medical condition (for example dialysis) or concomitant
             medication that would preclude participation in the study

          -  Are moribund irrespective of the provision of treatments

          -  Have a known history or show evidence of human immunodeficiency virus (HIV) and/or
             hepatitis

          -  Have recently undergone major surgery or central venous access device placement

          -  Have a significant bleeding disorder or active vasculitis

          -  Have experienced a thromboembolic event

          -  Have symptomatic congestive heart failure, or symptomatic or poorly controlled cardiac
             arrhythmia

          -  Have a serious, nonhealing wound, peptic ulcer, or bone fracture

          -  Have liver cirrhosis

          -  Have a known sensitivity to monoclonal antibodies (mAbs) or other therapeutic proteins

          -  Have a history of hypertensive crisis or hypertensive encephalopathy or current,
             poorly controlled hypertension
Effect of Vitamin D Repletion on Insulin Resistance and Systemic Inflammation
Condition: Insulin Resistance
MeSH terms: Insulin Resistance; Inflammation
Intervention: Vitamin D; Placebo
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 19.0
Sex: All
Minimum age: 21 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Glucose Metabolism Disorders; Insulin Resistance; Endocrine System; Vitamin D

Summary:

      The purpose of this research is to study the effects of Vitamin D supplementation on the
      body's response to insulin (a hormone that controls blood sugar), on inflammation, and on
      specific cells and processes in fat tissue.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Serum 25(OH)D<20ng/ml

          -  Insulin Resistant based on HOMA-IR score of >3

          -  Able and willing to provide informed consent

          -  BMI 20-35

        Exclusion Criteria:

          -  HIV/AIDS

          -  History of any cancer

          -  Sarcoidosis

          -  Alcohol or substance abuse

          -  Cushing's syndrome

          -  Primary hyperparathyroidism

          -  Nephrolithiasis

          -  Pregnancy or breastfeeding

          -  Regular visits to a tanning salon

          -  Hypercalcemia or hypocalcemia

          -  Untreated or uncontrolled hypertension

          -  Any chronic illness requiring medication, other than arthritis, hypertension and
             hyperlipidemia
Auto Transplant High Dose Melphalan vs High Dose Melphalan+Bortezomib in Pts With Multiple Myeloma Age 65 Years or Older
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Melphalan; Bortezomib
Intervention description: Melphalan is administered at a dose of 200mg/m2 by rapid intravenous infusion via a central or peripheral vein over 30 minutes to one hour.
Melphalan will be given as a single dose (not split over 2 or more days) and given on day-1.
Dosing will be based on body surface area calculated using actual body weight
Stem cell infusion:
Stem cell infusion will occur on day 0 and will be at least 20 hours after the infusion of melphalan. The infusion of peripheral blood stem cells will be done in accordance with the Blood and Marrow Transplant program standard operating procedures.
Filgrastim will be administered at a dose of 5 mcg/kg (rounded to vial size) every other day starting on day+3 then daily starting on day 9 until engraftment (at least).; Bortezomib:
Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line. Bortezomib will be administered any time on day -4 and at least 20 hrs after the start of the melphalan infusion on day -1.
Intervention MeSH terms: Bortezomib; Melphalan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: multiple myeloma; transplant

Summary:

      In this study the investigators are comparing this standard regimen to the newly established
      regimen of melphalan and bortezomib.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of multiple myeloma less than 12 months since initiation of
             systemic therapy

          -  Age ≥60 years at time of transplantation

          -  KPS 70-100%

          -  Recovery from complications of prior therapy

        Exclusion Criteria:

          -  Diagnosis other than multiple myeloma

          -  Chemotherapy or radiotherapy within 8 days of initiating treatment in this study

          -  Prior dose-intense therapy within 56 days of initiating treatment in this study

          -  Uncontrolled bacterial, viral, fungal or parasitic infections

          -  Uncontrolled CNS metastases

          -  Known amyloid deposition in heart

          -  Organ dysfunction

          -  LVEF <40% or cardiac failure not responsive to therapy

          -  FVC, FEV1 or DLCO < 40% of predicted and/or receiving supplementary continuous oxygen

          -  Evidence of hepatic synthetic dysfunction or total bilirubin > 2x or AST > 3x ULN

          -  Measured creatinine < 20ml/min

          -  Sensory peripheral neuropathy grade 4 within 14 days of enrollment

          -  Karnofsky score < 70%

          -  Life expectancy limited by other co-morbid illnesses
LME636 in the Relief of Persistent Ocular Discomfort in Subjects With Severe Dry Eye Disease
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: LME636 ophthalmic solution; LME636 Vehicle
Intervention description: Inactive ingredients used as a placebo comparator
Intervention MeSH terms: Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 514.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: LME636; dry eye disease; efficacy; ocular discomfort

Summary:

      The purpose of this study is to evaluate the efficacy of LME636 compared to vehicle in the
      reduction of ocular symptoms and to evaluate the safety and tolerability of LME636, when
      administered topically for up to 42 days, in subjects with severe dry eye disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must sign written informed consent.

          -  Physician diagnosis of DED of at least 6 months prior to Visit 1.

          -  Must use artificial tears, gels, lubricants or re-wetting drops on a regular basis.

          -  Respond as "often" or "constantly" to the question "How often do your eyes feel
             uncomfortable?".

          -  Best Corrected Visual Acuity (BCVA) of 55 or greater in each eye as measured by ETDRS
             at Visit 1.

          -  Other protocol-specified inclusion criteria may apply.

        Exclusion Criteria:

          -  Presence of any acute infection or non-infectious ocular condition in either eye
             within 1 month of Visit 1.

          -  Contact lens wearers, defined as individuals who cannot be without their contact
             lenses for the entire duration of the study.

          -  Any chronic ocular degenerative condition that in the opinion of the Investigator
             could possibly advance during the time course of the study.

          -  Use of biologics treatments, such as systemic biologic anti-cytokines, including
             anti-TNFα drugs, or immunosuppressive therapy for the treatment of severe systemic
             autoimmune disorders.

          -  Diseases or conditions affecting the ocular surface that are associated with
             clinically significant scarring and or destruction of conjunctiva and/or cornea.

          -  Unwilling to abstain from topical ocular non-prescription medications during the
             course of the study, including concomitant use of artificial tears, gels, lubricants,
             re-wetting drops, allergy drops, etc. after Visit 2.

          -  Use of nasal, inhaled, systemic (including injections), or topical corticosteroids
             within 30 days of Visit 1.

          -  Women of child-bearing potential unwilling to use effective contraception methods as
             defined in the protocol.

          -  Other protocol-specified exclusion criteria may apply.
PK and ECG Determinations Following 8 Weeks of HyBryte Treatment for Cutaneous T-Cell Lymphoma
Condition: Cutaneous T-Cell Lymphoma/Mycosis Fungoides
MeSH terms: Mycoses; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Mycosis Fungoides; Lymphoma, T-Cell, Cutaneous
Intervention: Hypericin
Intervention description: HyBryte is synthetic hypericin formulated as a 0.25% hypericin ointment.
Intervention MeSH terms: Hypericin
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CTCL; MF; Hypericin; HyBryte

Summary:

      To assess the blood levels of hypericin and any electrocardiogram (ECG) changes during 8
      weeks of HyBryte (topical hypericin ointment) photodynamic therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A clinical diagnosis of cutaneous T-cell lymphoma (CTCL, mycosis fungoides), Stage IB
             or Stage IIA

          -  CTCL lesions covering ≥ 10% of their body surface area

        Exclusion Criteria:

          -  History of allergy or hypersensitivity to any of the components of HyBryte

          -  Pregnancy or mothers who are breast-feeding

          -  Males and females not willing to use effective contraception

          -  Subjects with history of sun hypersensitivity or photosensitive dermatoses (e.g.,
             porphyria, systemic lupus erythematosus (SLE), Sjogren's syndrome, etc.)

          -  Subjects whose condition is spontaneously improving

          -  Subjects receiving topical steroids or other topical treatments (e.g., nitrogen
             mustard) on index lesions for CTCL within 2 weeks of enrollment

          -  Subjects receiving systemic steroids, psoralen ultraviolet A (UVA) radiation therapy
             (PUVA), narrow band ultraviolet B (UVB) light therapy (NB-UVB) or carmustine (BCNU) or
             other systemic therapies for CTCL within 3 weeks of enrollment

          -  Subjects who have received electron beam irradiation within 3 months of enrollment

          -  Subjects with a history of significant systemic immunosuppression

          -  Subjects taking other investigational drugs or drugs of abuse within 30 days of
             enrollment

          -  Subjects receiving drugs known to cause photosensitization within 2 weeks of starting
             HyBryte therapy unless they have not had evidence of photosensitization after
             receiving a stable dose of the medication for a minimum of 4 weeks
Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Multi-Site Phase 2b Clinical Study
Condition: Onychomycosis
MeSH terms: Onychomycosis
Intervention: NVXT topical; Placebo (Vehicle) Topical
Intervention description: topical treatment; Placebo (Vehicle) Topical
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 184.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Multi- Site Phase 2b Clinical
      Study to Assess the Efficacy, Safety and Tolerability of 8-Week Regimens of NVXT topical
      product in Patients with Mild to Moderate Onychomycosis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of onychomycosis of the target toenail (defined as one of the
             infected great toenails).

        Exclusion Criteria:

          -  Females who are pregnant, lactating or likely to become pregnant during the study.
Evaluation of AXR-270 for the Treatment of Posterior Blepharitis Associated With Meibomian Gland Dysfunction
Condition: Posterior Blepharitis; Meibomian Gland Dysfunction
MeSH terms: Meibomian Gland Dysfunction; Blepharitis
Intervention: AXR-270 Low Dose; AXR-270 High Dose; AXR-270 Vehicle
Intervention description: AXR-270 Topical Eyelid Cream; AXR-270 Topical Eyelid Cream; AXR-270 Topical Eyelid Cream Vehicle
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 129.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Meibomian Gland Dysfunction; Posterior Blepharitis

Summary:

      This study will evaluate the safety, tolerability and efficacy of AXR-270 Cream in treating
      posterior blepharitis associated with Meibomian Gland Disease (MGD)
    

Eligibility criteria:

        Inclusion Criteria:

        Male or female, 18 years or older

        Have a clinical diagnosis of moderate to severe MGD (total MGD score between 5 and 14 on a
        scale with a range between 0 and 15; and clinical severity score of eyelid margin
        vascularity of at least 2 (moderate))

        Have a score of ≥35 on Eye Discomfort using VAS

        Have a tFCS score between 3 and 14 on the NEI scale

        Have a Schirmer score of >7 mm

        Have a OSDI score >30

        If female, then subject should be non-pregnant and non-lactating

        Exclusion Criteria:

        Subjects with iritis, uveitis in either eye

        Subjects with conjunctivitis, keratitis, severe anterior keratitis not related to MGD

        Subjects with lid abnormalities

        Subjects with ocular fungal, viral or bacterial infection

        Subjects unable or unwilling to withhold the use of eyelid scrubs

        Subjects with glaucoma and serious systemic disease