bioihbjkbjnl/mcl2 huggingface dataset:
Study of the Pharmacodynamic Activity of P-321 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Disease
Condition: Dry Eye Disease
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: P-321 Ophthalmic Solution; P-321 Ophthalmic Solution placebo
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this Phase 2a study is to assess changes in tear volume by the non-invasive
      techniques Ultra High Resolution Optical Coherence Tomography (UHR-OCT) following the
      administration of P-321 Ophthalmic Solution or Placebo in subjects with tear deficient dry
      eye disease.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Provide written informed consent

          2. Male or female subjects aged 18 to 80 years

          3. Have a history of predominantly tear-deficient dry eye of mild to moderate severity,
             supported by a previous clinical diagnosis

          4. Have normal lid anatomy

          5. Subjects must:

               1. Remain on current medications for the duration of the study and have been on the
                  current medication regimen at least during the past 28 days

        Exclusion Criteria:

          1. Have undergone refractive eye surgery in either eye during the past 12 months

          2. Have undergone uncomplicated cataract surgery in either eye during the past 3 months

          3. Have undergone previous eyelid surgery in either eye (External blepharoplasty, not
             resulting in exposure or abnormal blinking is allowed)

          4. Have undergone botulinum toxin (BotoxTh1 or equivalent) injection in the periocular
             area within 3 months prior to Visit 1

          5. Subjects that have a systemic, multi-organ disease requiring active medical or
             surgical treatment are excluded with the exception of subjects with SS or GVHD

          6. Have punctal plugs, punctal occlusion, history of nasolacrimal duct obstruction or
             wear scleral lens.

          7. Past or present exposure keratopathy, neurotrophic keratopathy, lagophthalmos, or
             trichiasis
Ibrutinib (PCI-32765) in Waldenstrom's Macroglobulinemia
Condition: Waldenstrom's Macroglobulinemia
MeSH terms: Waldenstrom Macroglobulinemia
Intervention: PCI-32765
Intervention description: Taken orally, once daily in the morning
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Relapsed; Refractory

Summary:

      This research study is a Phase II clinical trial. Phase II clinical trials test the
      effectiveness of an investigational drug, PCI-32765, to learn whether PCI-32765 works in
      treating a specific cancer. "Investigational" means that PCI-32765 is still being studied and
      that research doctors are trying to find out more about it-such as the safest dose to use,
      the side effects it may cause, and if PCI-32765 is effective for treating different types of
      cancer. It also means that the FDA has not yet approved PCI-32765 for use in patients,
      including people with Waldenstrom's Macroglobulinemia.

      PCI-32765 is a newly discovered drug that is being developed as an anti-cancer agent.
      PCI-32765 is a Bruton's tyrosine kinase (Btk) inhibitor drug which interrupts B cell receptor
      (BCR) signaling in lymphomas by selectively and irreversibly binding to the Btk protein,
      which then results in malignant cell death. This drug has been used in laboratory experiments
      and other research studies in B-cell malignancies and information from those other research
      studies suggests that PCI-32765 may be a treatment strategy for B-cell malignancies,
      including Waldenstrom's Macroglobulinemia.

      In this research study, the investigators are testing the safety and efficacy of PCI-32765 as
      a treatment option for relapsed or refractory Waldenstrom's Macroglobulinemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinicopathological diagnosis of Waldenstrom's Macroglobulinemia

          -  Measurable disease

          -  Have received at least one prior therapy for WM therapies

          -  Disease free of prior malignancies

          -  Able to adhere to study visit schedule and other protocol requirement

        Exclusion Criteria:

          -  Pregnant or breastfeeding

          -  Any other serious medical condition

          -  Concurrent use of other anti-cancer agents or treatments

          -  Prior exposure to PCI-32765

          -  Known CNS lymphoma

          -  Significant cardiovascular disease

          -  Any disease affecting gastrointestinal function
Proton Radiotherapy for Patients With Non-Small Cell Lung Cancer (NSCLC)
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Proton Radiotherapy
Intervention description: 87.5 CGE with 2.5 Gy/fraction for 35 treatments
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Healthy volunteers: No
Keywords: Non-Small Cell Lung Cancer; Lung Cancer; Proton Radiotherapy; Proton Beam; NSCLC

Summary:

      The goal of this clinical research study is to learn if escalated/accelerated proton
      radiotherapy can improve the control of Non-Small Cell Lung Cancer (NSCLC) and decrease side
      effects. The safety of this treatment will also be studied.

      Objectives:

      To assess the therapeutic efficacy and toxicities of proton radiotherapy with
      escalated/accelerated dose for patients with medically inoperable stage I (T1-2, N0,M0)
      NSCLC.

      Primary goals:

        1. Improve 2 years progression free survival at the primary site, and

        2. reduce acute and chronic toxicity

      Secondary goals:

        1. Improve disease specific survival at 2 years.

        2. Study the potential of pre- and post treatment PET/CT in predicting clinical outcome.

        3. Study the role of biomarkers in predicting therapeutic response and toxicities.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histologically or cytologically documented NSCLC.

          2. Patients with inoperable centrally located tumors, defined as those within 2 cm of the
             bronchial tree, major vessels, esophagus, heart, or other mediastinal structures but
             no direct invasion, T1N0M0 (stage IA), or any location of T2N0M0 (stage IB) and T3N0M0
             (selected stage II with chest wall involvement) NSCLC.

          3. Performance score KPS 60-100.

        Exclusion Criteria:

          1. Prior radiotherapy to the chest.

          2. Previous or concomitant malignancy other than (a) curatively treated carcinoma in situ
             of cervix, (b) basal cell carcinoma of the skin, (c) curatively treated superficial
             transitional cell carcinoma of the urinary bladder, and (d) early stage tumor treated
             more than 3 years ago for cure.

          3. Pregnancy. Patients, both men and women of child bearing potential should use an
             effective method of birth control throughout their participation in this study.
The CHARM Trial: Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts
Condition: Mucinous Pancreatic Cysts
MeSH terms: Pancreatic Cyst
Intervention: Ethanol; Normal Saline; Chemotherapy
Intervention description: Cysts will be lavaged for 3-5 minutes with 80% EtOH; Cysts will be lavaged for 3-5 minutes with normal saline; Following lavage with either 80% ethanol (control group) or normal saline (study group), cysts will be injected with a cocktail of 3mg/ml paclitaxel and 19mg/ml gemcitabine.
Intervention MeSH terms: Ethanol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pancreatic cyst; chemotherapy; ethanol; ablation

Summary:

      The purpose of this study is to evaluate the efficacy of a chemotherapeutic cocktail with or
      without prior ethanol lavage for ablation of premalignant pancreatic cysts using endoscopic
      ultrasound-guided fine needle injection (EUS-FNI) for agent delivery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients age 18 and older of any gender, ethnicity and race

          -  Voluntary enrollment and ability to give written informed consent

          -  Capable of safely undergoing endoscopy with deep sedation or general anesthesia

          -  Patients with previously-detected pancreatic cyst(s) 1-5 cm in diameter, including
             indeterminate cysts

        Exclusion Criteria:

          -  Pancreatic cyst <1cm or >5cm

          -  Pancreatic cyst with clear communication with main pancreatic duct

          -  Clearly benign lesions by clinical and radiographic evaluation (pseudocysts and serous
             cystadenomas)

          -  Known or suspected pancreatic cancer or pathologic lymphadenopathy

          -  Septated cysts with > 5 compartments

          -  Coagulopathy (international normalized ratio > 1.6, platelets < 30,000)

          -  Evidence of active pancreatitis or pancreatic infection

          -  Patients having undergone endoscopic retrograde cholangiopancreatography (ERCP) within
             72 hours

          -  Baseline lab values at the time of consent: white blood cells > 14 or < 2, hematocrit
             < 30, platelets < 30,000, INR > 1.6, abnormal CA19-9, lipase > 3 times the upper limit
             of normal, creatinine > 2.5, ALT > 210, total bilirubin > 2.5, positive qualitative
             beta-hCG.

          -  Any pre-existing or discovered medical condition that may, at the discretion of the
             investigator, interfere with the completion of and/or participation in the existing
             protocol.

          -  Pregnant, breastfeeding, or incarcerated individuals
Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180mg When Added to PCSK9 Inhibitor Therapy
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: bempedoic acid 180mg; placebo; evolocumab
Intervention description: Daily bempedoic acid 180mg tablet in addition to monthly PCSK9i (evolocumab) background therapy; Daily matching placebo tablet in addition to monthly PCSK9i (evolocumab) background therapy; Monthly PCSK9i (evolocumab) background therapy
Intervention MeSH terms: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid; Evolocumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cholesterol; PCSK9; Repatha; evolocumab; LDL-C

Summary:

      The purpose of this study is to determine if bempedoic acid (ETC-1002) 180mg added to PCSK9
      inhibitor (evolocumab) therapy is effective and safe in patients with elevated LDL
      cholesterol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥18 years or legal age of majority depending on regional law

          -  Fasting, calculated LDL-C at screening ≥160 mg/dL and following PCSK9i therapy ≥70
             mg/dL

          -  Men and nonpregnant, nonlactating women

        Exclusion Criteria:

          -  Heterozygous (HeFH) or Homozygous (HoFH) Familial Hypercholesterolemia

          -  Total fasting TG ≥500 mg/dL

          -  Renal dysfunction or a glomerulonephropathy; eGFR <30 mL/min/1.73 m2

          -  Known cardiovascular disease (CVD), peripheral arterial disease (PAD), or
             cerebrovascular disease (CD)

          -  History of type 1 or type 2 diabetes

          -  Uncontrolled hypertension

          -  Uncontrolled hypothyroidism

          -  Liver disease or dysfunction

          -  Gastrointestinal conditions or procedures (including Lap-Band® or gastric bypass)

          -  History of hematologic or coagulation disorders

          -  History of malignancy (except non-metastatic basal or squamous cell carcinoma of the
             skin and cervical carcinoma in situ)

          -  Unexplained creatine kinase (CK) >3 × ULN

          -  Use of a cholesterylester transfer protein (CETP) inhibitor in the last 12 months
             prior to screening, such as: anacetrapib, dalcetrapib, or evacetrapib

          -  Pregnant or breast feeding, or planning to become pregnant during treatment and/ or
             within 30 days after the end of treatment
Safety, Tolerability, and Efficacy of Caspofungin Versus Amphotericin B Deoxycholate in the Treatment of Invasive Candidiasis in Neonates and Infants (MK-0991-064)
Condition: Candidiasis, Invasive
MeSH terms: Candidiasis; Candidiasis, Invasive
Intervention: Caspofungin; Amphotericin B Deoxycholate
Intervention MeSH terms: Amphotericin B; Liposomal amphotericin B; Caspofungin; Amphotericin B, deoxycholate drug combination; Deoxycholic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 51.0
Sex: All
Maximum age: 3 Months
Healthy volunteers: No

Summary:

      The study will evaluate the safety, tolerability, and efficacy of caspofungin as compared
      with amphotericin B deoxycholate in the treatment of invasive candidiasis in neonates and
      infants. The primary hypothesis to be tested in the study is that caspofungin will be
      superior to amphotericin B deoxycholate with regard to the proportion of participants with
      fungal-free survival at the 2-week post-therapy follow-up visit.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Culture-confirmed invasive Candida infection

        Exclusion Criteria:

          -  Candida disease limited to the oropharynx, esophagus, or other mucosal or superficial
             skin surfaces

          -  Positive culture for Candida only from sputum, broncho-alveolar lavage, catheter tip,
             or previously placed indwelling non-vascular catheters or drains

          -  Prosthetic device as the suspected site of Candida infection

          -  Active co-infection with a non-Candida fungal organism

          -  Received >48 hours of systemic antifungal treatment since the positive Candida index
             culture was collected as therapy for the present episode of invasive candidiasis

          -  Failed prior systemic antifungal therapy for the present episode of invasive
             candidiasis

          -  Diagnosis of acute hepatitis or cirrhosis

          -  Scheduled or anticipated to receive rifampin or other systemic antifungal therapy
             while on study therapy

          -  History (including participant's mother) of allergy, hypersensitivity, or any serious
             reaction to caspofungin or other member of the echinocandin class, or to amphotericin
             B deoxycholate or other member of the polyene class

          -  Severe congenital disorder known to lower immune response
Long-term Safety and Tolerability of Atacicept (Long-term Follow-Up of Participant Who Participated in ADDRESS II)
Condition: Lupus Erythematosus, Systemic
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Atacicept 75 mg; Atacicept 150 mg; Atacicept 150 mg
Intervention description: Participants who received atacicept 75 milligram (mg) as once-weekly subcutaneous injection in the core study ADDRESS II continued to receive this dose during this LTE study. Participants in this reporting arm received the medication up to a maximum of 143.7 weeks.; Participants who received placebo in the core study ADDRESS II switched to receive atacicept 150 mg as once-weekly subcutaneous injection for up to a maximum of 97.7 weeks during this LTE study.; Participants who received atacicept 150 mg in core study ADDRESS II continued to receive atacicept 150 mg as once-weekly subcutaneous injection during this LTE study up to a maximum of 97.9 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 253.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lupus Erythematosus, Systemic; Atacicept 75 and 150 mg; LTE

Summary:

      This is a multicenter, double-blind, Phase 2b, long-term extension (LTE) to the ADDRESS II
      core trial (EMR 700461-023) (NCT01972568), to evaluate long-term safety and tolerability of
      atacicept in participants with systemic lupus erythematosus (SLE). Participants who completed
      the 24-week core study ADDRESS II core study (NCT01972568) and thus not met any of the
      discontinuation criteria were invited to enter this long-term extension (LTE) study
      NCT02070978.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who had completed the 24-week treatment period of study EMR-700461-023
             (ADDRESS II core trial)

          -  Women of childbearing potential who had a negative pregnancy test

          -  Other protocol defined inclusion criteria were applied

        Exclusion Criteria:

          -  Active neurological symptoms of SLE that were deemed severe or progressive

          -  Diagnosis of any demyelinating disease, such as, but not restricted to, multiple
             sclerosis (MS) or optic neuritis

          -  Pregnancy

          -  Active clinically significant viral, bacterial, or fungal infection, or any major
             episode of infection that in the investigator's opinion makes the participants
             unsuitable to continued participation in the study

          -  Other protocol defined exclusion criteria were applied
Measuring Ambulation, Motor, and Behavioral Outcomes With Post-Stroke Fluoxetine in Tanzania
Condition: Acute Stroke; Stroke, Ischemic
MeSH terms: Stroke; Ischemic Stroke
Intervention: Fluoxetine 20 MG Oral Tablet
Intervention description: Once-daily dosing for 90 days
Intervention MeSH terms: Fluoxetine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Phase II study of one dose
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Motor recovery

Summary:

      This is a phase II, randomized study of 120 adults age 18 or above who will prescribed 20mg
      daily Fluoxetine for 90 days following acute, ischemic stroke.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participant is 18 years of age or older

          2. Participant has experienced a CT-confirmed ischemic stroke w/in 21 days of enrollment

        Exclusion Criteria:

          1. NIH Stroke Scale Score >20 points

          2. Unconscious at presentation

          3. Hemorrhagic conversion of ischemic infarct

          4. transient ischemic symptoms <24h,

          5. Current antidepressant or psychoactive drug use (e.g. SSRI, monoxidase amine
             inhibitor, benzodiazepine).

          6. Current pregnancy.

          7. History of recent head trauma.

          8. Baseline motor deficits from other etiologies including prior stroke.

          9. Dysphagia preventing the swallowing of a pill.

         10. Hyponatremia (<125 mmol/L), hepatic impairment as defined by a serum alanine
             aminotransferase (ALT) of >120 U/L.

         11. Renal impairment as defined by a creatinine >180 micromol/L or GFR <30mL/min/1.73m2.

         12. Patients who are moribund for other reasons and unlikely to survive to 90 days will
             also be excluded from participation.

         13. Contraindication to MRI (e.g. piercings/tattoos, electronic/metallic implants,
             claustrophobia)

         14. Contraindication to lumbar puncture (e.g. infection at site of needle insertion,
             evidence of elevated ICP, coagulopathy/thrombocytopenia or use of therapeutic
             anticoagulation, or a history of LP complications).
Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of SBC-102 (Sebelipase Alfa) in Adult Subjects With Lysosomal Acid Lipase Deficiency
Condition: Cholesterol Ester Storage Disease (CESD); Lysosomal Acid Lipase Deficiency; LAL-Deficiency
MeSH terms: Wolman Disease; Cholesterol Ester Storage Disease
Intervention: sebelipase alfa
Intervention description: Sebelipase alfa is a recombinant human lysosomal acid lipase.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Enzyme replacement therapy (ERT); Lysosomal storage disease; Late onset lysosomal acid lipase (LAL) deficiency; Acid cholesteryl ester hydrolase deficiency, type 2; Acid lipase disease; Cholesterol ester hydrolase deficiency; LAL deficiency; LIPA enzyme deficiency

Summary:

      This was an extension study to Study LAL-CL01 (NCT01307098). The primary objective of the
      study was to evaluate the long-term safety and tolerability of sebelipase alfa in
      participants with liver dysfunction due to lysosomal acid lipase (LAL) deficiency.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant received all 4 scheduled doses of sebelipase alfa in Study LAL-CL01 with
             no life-threatening or unmanageable study drug toxicity.

        Exclusion Criteria:

          -  Clinically significant concurrent disease, serious inter-current illness, concomitant
             medications or other extenuating circumstances

          -  Clinically significant abnormal values on laboratory screening tests, other than LFTs
             or lipid panel tests