bioihbjkbjnl/mcl2 huggingface dataset:
An Evaluation of AZR-MD-001 as Treatment for Meibomian Gland Dysfunction (MGD) or Contact Lens Discomfort (CLD)
Condition: Meibomian Gland Dysfunction (MGD); Contact Lens Discomfort (CLD)
MeSH terms: Meibomian Gland Dysfunction
Intervention: AZR-MD-001 Vehicle; AZR-MD-001 Active Dose
Intervention description: AZR-MD-001 is an ophthalmic ointment; AZR-MD-001 is an ophthalmic ointment
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      SOVS2019-070 is a single-center study of AZR-MD-001 ointment and AZR-MD-001 vehicle in
      patients with Meibomian Gland Dysfunction (MGD) or Contact Lens Discomfort (CLD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  MGD Patients:

               -  Evidence of meibomian gland obstruction (based on a meibomian gland secretion
                  (MGS) score of ≤12 for 15 glands of the lower lid) in both eyes at the baseline
                  visit

               -  Reported dry eye signs and symptoms within the past 3 months

               -  TBUT < 10 seconds in both eyes

          -  CLD Patients:

               -  Evidence of meibomian gland obstruction (based on a meibomian gland secretion
                  (MGS) score of ≤12 for 15 glands of the lower lid) in both eyes at the baseline
                  visit

               -  A history of wearing soft contact lenses for at least 6 months

               -  Wearing of the soft contact lenses for at least 3 weeks before the baseline visit
                  and wore or attempted to wear lenses at least 4 times a week before the baseline
                  visit.

               -  Symptomatic as defined by an answer of "No" at baseline to the question, "Are you
                  able to comfortably wear your lenses as long as you want?"

               -  Self-reported history of contact lens dryness/intolerance in the 6 months
                  preceding the baseline visit.

               -  Baseline CLDEQ-8 score >12

               -  Contact lens may be use during the study as long as they are removed 15 minutes
                  before dosing and not reinserted until at least 15 minutes after dosing.

        Exclusion Criteria:

          -  Uncontrolled ocular disease (except for MGD or CLD) or uncontrolled systemic disease

          -  Patient has glaucoma or ocular hypertension

          -  Corneal abnormality or disorder that impacts normal spreading of the tear film or
             corneal integrity

          -  BCVA worse than 20/40 in either eye at the baseline visit
An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide
Condition: Early Stage HER2+ Breast Cancer
MeSH terms: Breast Neoplasms; Diarrhea
Intervention: Neratinib; Loperamide; Colestipol; Budesonide
Intervention description: 2 g twice daily with or without food for one 28 day cycle; 9 mg extended release tablets once daily with or without food for 28 days
Intervention MeSH terms: Budesonide; Loperamide; Antidiarrheals; Colestipol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 563.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HER2 +; Breast Cancer; Neratinib; Nerlynx; Loperamide; Colestipol; Budesonide

Summary:

      An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients with
      Early-Stage HER2+ Breast Cancer Treated with Neratinib and Loperamide or other prophylactic
      measures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥18; male or female

          -  Early breast cancer (stage I-3c)

          -  Documented HER2+ tumor: HER2 immunohistochemistry (IHC) 3+ or ISH+

          -  Prior course of adjuvant trastuzumab given >2 weeks and ≤1 year from enrollment

          -  No evidence of local/regional recurrence or metastatic disease

          -  Eastern Cooperative Oncology Group (ECOG) status of 0 or 1

          -  Male patients with female partners of childbearing potential must agree and commit to
             use a condom and women of childbearing potential must not be pregnant and must agree
             and commit to the use of a highly effective non-hormonal method of contraception

          -  Left ventricular ejection fraction (LVEF) ≥50% measured by multiple-gated acquisition
             scan (MUGA) or ECHO

        Exclusion Criteria:

          -  Major surgery < 30 days

          -  Chemotherapy, investigational agents, other cancer therapy (except hormonal therapy) <
             14 days

          -  Corrected QT Interval (QTc) >0.450 seconds (males) or >0.470 (females) or other active
             cardiac disease

          -  Significant chronic GI disorder with diarrhea as a major symptom

          -  Active, unresolved infections

          -  Currently pregnant or breast-feeding
Doravirine Concentrations and Antiviral Activity in Genital Fluids in HIV-1 Infected Individuals
Condition: HIV-1-infection
Intervention: Doravirine; Descovy
Intervention description: Doravirine 100 mg tablet; Tenofovir alafenamide 25 mg / emtricitabine 200 mg tablet
Intervention MeSH terms: Emtricitabine tenofovir alafenamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Patients with Doravirine administered orally once daily in combination with Tenofovir alafenamide (TAF) and emtricitabine (FTC) co-formulated as single tablet (Descovy® TAF/FTC) and administered orally once daily.
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Doravirine

Summary:

      This study aims to evaluate the ability of Doravirine to penetrate the genital tract and
      suppress viral replication and provide evidence for the use of Doravirine as part of
      treatment strategies as prevention.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Asymptomatic, HIV-1 infected individuals ≥ 18 years of age.

          2. Be on a stable ART consisting of TAF/FTC, tenofovir disoproxil fumarate/emtricitabine
             or abacavir/lamivudine, plus an non-nucleoside reverse transcriptase inhibitor, a
             boosted protease inhibitor or an integrase inhibitor, continuously for at least 3
             consecutive months preceding the screening visit.

          3. Plasma HIV-1 RNA <40 copies/mL for at least 6 months at the Screening visit.

          4. Signed and dated written informed consent prior to inclusion.

          5. Female Subjects of Childbearing Potential must agree to utilize a highly effective
             method of contraception during heterosexual intercourse from the screening visit
             throughout the duration of the study.

        Exclusion Criteria:

          1. Severe hepatic impairment (Child-Pugh Class C)

          2. Ongoing malignancy

          3. Active opportunistic infection

          4. Resistance to any of the antiretroviral (ARV) included in the study or history of
             virologic failure with risk of resistance selection to any of the study drugs.

          5. Any verified Grade 4 laboratory abnormality

          6. ALT or AST ≥ 3xULN and/or bilirubin ≥ 1.5xULN

          7. Severe renal impairment (Estimated creatinine filtration rate <50mL/min).

          8. Females who are pregnant (as confirmed by positive serum pregnancy test) or
             breastfeeding.
Spironolactone With Patiromer in the Treatment of Resistant Hypertension in Chronic Kidney Disease
Condition: Hyperkalemia; Resistant Hypertension
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hypertension; Hyperkalemia
Intervention: Patiromer; Placebo; Spironolactone
Intervention description: 2 packets/day starting dose, administered orally; 2 packets/day starting dose, administered orally; 25 mg tablet/day starting dose, administered orally
Intervention MeSH terms: Spironolactone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 295.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Treatment of Hyperkalemia; Hyperkalemia; Potassium; Chronic Kidney Disease; Hypertension; Resistant Hypertension; Spironolactone

Summary:

      The purpose of this study is to determine if patiromer treatment in chronic kidney disease
      (CKD) subjects receiving spironolactone for the treatment of resistant hypertension will
      result in more persistent use of spironolactone through prevention of hyperkalemia and lead
      to improved blood pressure control compared with treatment with spironolactone alone
      (placebo).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years

          -  Taking at least three medications for blood pressure (one a diuretic)

          -  Uncontrolled high blood pressure

          -  Abnormal kidney function (with-eGFR, a measure of kidney function, of 25 - ≤ 45
             mL/min/1.73m2

          -  Normal Blood serum Potassium in a specific range (4.3 - 5.1 mEq/L)

        Exclusion Criteria:

          -  History of untreated known causes of high blood pressure, excluding kidney disease
             (not CKD)

          -  Inability to measure BP

          -  Not taking high blood pressure medications as prescribed medications

          -  Recent change in renal function (in the past 3 months) which has required
             hospitalization or dialysis

          -  Renal transplant

          -  History of cancer within past 12 months

          -  Recent cardiovascular event with last 3 months

          -  Clinically significant abnormalities of heart rhythm (ventricular arrhythmia or atrial
             fibrillation with uncontrolled heart rate)

          -  Inability to take study medication

          -  Alcoholism
Staccato Prochlorperazine in Migraine (in Clinic)
Condition: Migraine Headache, With or Without Aura
MeSH terms: Migraine Disorders; Headache
Intervention: Staccato Placebo; Staccato Prochlorperazine 5 mg; Staccato Prochlorperazine 10 mg
Intervention description: Inhaled Staccato Placebo; Inhaled Prochlorperazine 5 mg; Inhaled Prochlorperazine10 mg
Intervention MeSH terms: Prochlorperazine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Migraine, Staccato Prochlorperazine; Migraine headache with or without aura.

Summary:

      Development of Staccato Prochlorperazine for the treatment of migraine headache.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who have migraine headache with or without aura (diagnosis according to
             International Headache Society guidelines) for at least 6 months, who have been pain
             free for at least 48 hours since the end of their last migraine attack, who have a
             pain rating of Moderate or Severe prior to dosing.

        Exclusion Criteria:

          -  Subjects who have taken any other migraine or pain medication within 48 hours of
             randomization, with a history of allergy or intolerance to phenothiazines and related
             drugs, or are considered by the investigator, for any reason, to be an unsuitable
             candidate for receiving prochlorperazine, or unable to use the inhalation device, must
             be excluded.
An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: Beraprost Sodium Modified Release
Intervention MeSH terms: Epoprostenol; Beraprost
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is an open-label extension study for patients who participated in the BPS-MR-PAH-201
      study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who remained on study drug and completed all assessments during the Treatment
             Phase of Study BPS-MR-PAH-201 are eligible for this study.

          -  Female patients must either be physiologically incapable of childbearing or be
             practicing an acceptable method of birth control (e.g. approved hormonal
             contraceptive, barrier method, such as condom or diaphragm, used with a spermicide, or
             an intrauterine device).

        Exclusion Criteria:

          -  Patients who discontinued study drug during the previous study (BPS-MR-PAH-201) for
             any reason (e.g. treatment related adverse events) are not eligible for entry into
             this study.

          -  Patients who are pregnant or lactating are excluded from participation in the
             open-label extension.
Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Intervention: Budesonide plus Prevacid; placebo plus Prevacid
Intervention description: Budesonide is taken daily for three months. In addition, Prevacid is taken twice daily for three months.; Placebo is taken daily for three months. In addition, Prevacid is taken twice daily for three months.
Intervention MeSH terms: Budesonide; Lansoprazole; Dexlansoprazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 32.0
Sex: All
Minimum age: 1 Year
Healthy volunteers: No
Keywords: Eosinophils; Esophagitis; Microscopy

Summary:

      This study is designed to evaluate whether or not oral viscous budesonide is effective in
      treating children with Eosinophilic Esophagitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic evidence of EE defined as greater than 20 eosinophils per hpf on esophageal
             biopsy

          -  Ages 1 yrs and older

          -  Ability to continue the same diet that the patient was on at the time of EGD with
             biopsy

        Exclusion Criteria:

          -  Adverse reaction or allergy to budesonide

          -  Pregnancy

          -  Chronic diseases requiring immunomodulatory therapy

          -  Use of swallowed topical corticosteroids for EE within the past 3 months

          -  Use of systemic steroids 2 months prior to study entry

          -  Upper gastrointestinal bleed within 4 months of study entry

          -  Chronic use of medications that predispose to upper gastrointestinal bleeding
             including non-steroidal anti-inflammatory medications or anticoagulants

          -  Evidence of adrenal suppression prior to study entry

          -  Evidence of concurrent eosinophilic gastritis, enteritis, colitis, or proctitis

          -  Recent changes in asthma or allergic rhinitis therapy for 3 months
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed Dose Combination in the Treatment of Hepatitis C Virus (HCV) Infection in Pediatric Participants Undergoing Cancer Chemotherapy
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis
Intervention: LDV/SOF
Intervention description: Tablet(s) administered orally once daily
Intervention MeSH terms: Sofosbuvir; Ledipasvir, sofosbuvir drug combination; Ledipasvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: HCV genotype 1 or 4 (GT-1 or GT-4); Direct Acting Antiviral; Combination Therapy; Hepatitis C, Chronic; Liver Diseases; Virus Diseases

Summary:

      The primary objectives of this study are to evaluate the efficacy, safety, and tolerability
      of ledipasvir/sofosbuvir (LDV/SOF) in treating hepatitis C virus (HCV) infection in pediatric
      participants who are undergoing cancer chemotherapy.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Aged 12 to <18 years

          -  Parent or legal guardian must provide written informed consent

          -  Treatment naïve or experienced children with genotype 1 or 4 HCV infection, and are on
             a maintenance cancer chemotherapy regimen

          -  Receiving a protocol-approved maintenance chemotherapy regimen for a hematological
             malignancy

          -  Chronic HCV infection (≥ 6 months) documented by medical history or liver biopsy

          -  Screening laboratory values within defined thresholds

          -  No History of solid organ or bone marrow transplantation

          -  No history of clinical hepatic decompensation (eg, ascites, jaundice, encephalopathy,
             variceal hemorrhage)

        NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
To Assess the Safety and Activity of GBR 830, Compared to Placebo, in Adults With Moderate-to-severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: GBR 830; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the effect of GBR 830 on biomarkers in atopic
      dermatitis to enable further studies in this indication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, 18 years or older

          -  Atopic dermatitis involvement that of at least 10% body surface area

        Exclusion Criteria:

          -  Treatment with systemic corticosteroids within 4 weeks before randomization, and
             topical steroids, tacrolimus and/or pimecrolimus within 1 week before the
             randomization (except emollients, and mild steroids (class 6 or 7)

          -  Any cell-depleting agents including but not limited to rituximab: within 6 months
             prior to the baseline visit or until lymphocyte and CD 19+ lymphocyte counts return to
             normal, whichever is longer. Other biologics: within 5 half-lives or 8 weeks prior to
             the baseline visit, whichever is longer. Allergen immunotherapy within 6 months before
             the baseline visit.

          -  Patient with history of serious local infection and systemic infection Patient with
             history or current evidence of diseases such as tuberculosis, malignant disease, other
             inflammatory or autoimmune disease or HIV or Hepatitis B or C positive.
Is More Than One Dose of Misoprostol Needed to Expedite Vaginal Delivery in a Patient With an Unripe Cervix?
Condition: Labor; Forced or Induced, Affecting Fetus or Newborn
Intervention: Misoprostol
Intervention description: Misoprostol, a prostaglandin, binds to myometrial cells to cause strong myometrial contractions leading to expulsion of tissue. This agent also causes cervical ripening with softening and dilation of the cervix.
Intervention MeSH terms: Methotrexate; Misoprostol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 243.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: unripe cervix

Summary:

      The goal of this study is to determine whether inducing labor with just one dose of
      misoprostol, followed by treatment with oxytocin, will still be effective enough to increase
      the chances of having a successful vaginal delivery as compared to using more than one dose
      of misoprostol, followed by treatment with oxytocin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any pregnant woman undergoing induction of labor

          -  Live singleton pregnancy ≥ 37 week gestation

          -  Bishop score < 6

          -  Category I fetal heart rate

        Exclusion Criteria:

          -  Contraindications to vaginal delivery (e.g. vasa previa, placenta prevue,non-vertex
             presentation, umbilical cord prolapse, and active genital herpes infection.)

          -  Pregnancies complicated by major fetal anomalies

          -  Any contraindication to the use of misoprostol, including

          -  History of previous c-section or major uterine surgery

          -  Prior allergic reaction

          -  Category II or III fetal heart rate

          -  Regular uterine contractions ≥ 3 in a 10-minute period persistent for at least 30
             minutes

          -  Estimated fetal weight < 10 percentile

          -  Premature rupture of membranes

          -  Age < 18 years old

          -  Women who do not have the capacity to consent
Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients at Early Stage of the Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Intervention: Placebo; PF-06649751
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 57.0
Sex: All
Minimum age: 45 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Early Parkinson Disease; Phase 2

Summary:

      The purpose of this study is to evaluate the efficacy, safety and tolerability of PF-06649751
      in Parkinson's disease patients at early stage of the disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females of non-childbearing potential and/or male subjects

          -  Clinical diagnosis of Parkinson's disease.

          -  Parkinson's Disease Hoehn & Yahr Stage I-III inclusive

          -  Treatment naïve or history of prior incidental treatment with dopaminergic agents for
             no more than 28 days

          -  Able to refrain from any Parkinson's disease medication not permitted by the protocol.

        Exclusion Criteria:

          -  History or presence of atypical Parkinsonian syndrome.

          -  Severe acute or chronic medical or psychiatric condition or cognitive impairment or
             laboratory abnormality.

          -  Any condition possibly affecting drug absorption.

          -  Participation in other studies involving investigational drug(s), or treatment with
             any investigational drug within 30 days.