bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation 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 description: P-321 Ophthalmic Solution 0.017%; Placebo to match P-321 Ophthalmic Solution
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the effect of treatment with 0.017% P-321 on Dry Eye
      Symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Provide written informed consent

          2. Male or female subjects aged 18 to 80 years, inclusive

          3. Have a history of dry eye disease (DED) in both eyes

          4. Be on stable regimens of other needed medications

          5. Have a BCVA of +0.7 or better as assessed by Early Treatment of Diabetic Retinopathy
             Study (ETDRS)

          6. Have reported symptoms

          7. Have the following signs in at least one eye: Schirmer score without anesthesia of >1
             and <10 mm at 5 minutes and staining of conjunctival and corneal areas of the eye.

          8. Have normal lid anatomy

        Exclusion Criteria:

          1. Have undergone refractive eye surgery in the past 12 months

          2. Have undergone previous eyelid surgery in either eye (External blepharoplasty not
             resulting in exposure or abnormal blinking is allowed)

          3. Have lid irregularities or deformities

          4. Have a history of glaucoma, a history of an elevated lOP within the past year, or an
             lOP in either eye > 25 mmHg at the Screening Visit (Visit 1)

          5. Have any clinically significant, uncontrolled, or unstable medical or surgical
             conditions that could affect his or her ability to participate

          6. Have permanent punctal plugs, punctal occlusion, or history of nasolacrimal duct
             obstruction. Removable punctal plugs are allowed if they have been used regularly for
             at least 60 days prior to the screening visit. However, if a plug comes out during the
             study it must be promptly replaced.

          7. Have clinical findings of severe Meibomian Gland Dysfunction (MGD) in the Study Eye

          8. Are pregnant or breast feeding

          9. Use of any investigational product or device within 28 days prior to the Screening
             Visit or during the study
Evaluate the Efficacy and Safety of Pasireotide LAR (Long Acting Release) on the Treatment of Patients With Clinically Non-Functioning Pituitary Adenoma.
Condition: Non-functioning Pituitary Adenoma
MeSH terms: Adenoma; Pituitary Neoplasms; Pituitary Diseases
Intervention: Pasireotide LAR
Intervention description: 20 and 40 mg of powder in vials and 2 mL of vehicle in ampoules (for reconstitution) administered as a depot intragluteal IM (intramuscular) injection
Intervention MeSH terms: Pasireotide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-functioning pituitary adenoma,; pasireotide LAR,; tumor volume

Summary:

      This study assessed pasireotide LAR efficacy on patients with non-functioning pituitary
      adenomas concerning tumor growth.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-functioning pituitary adenoma ≥ 1cm, patients without any previous treatment for
             the tumor

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

        Exclusion Criteria:

          -  Patients who required a surgical intervention for relief of any sign or symptom
             associated with tumor compression

          -  Previous pituitary surgery

          -  Previous medical treatment for pituitary tumor

          -  Patients who had received pituitary irradiation within 10 years prior to randomization

          -  Prolactin (PRL) levels > 100 ng/mL. PRL evaluation should have been performed with
             diluted samples to ensure "hook effect." was avoided

          -  Patients who presented prolactinomas, acromegaly or Cushing's disease

          -  Patients with compression of the optic chiasm causing acute clinically significant
             visual field defects
Study of Pegilodecakin (LY3500518) With Pembrolizumab Compared to Pembrolizumab Alone First-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Pegilodecakin; Pembrolizumab
Intervention description: Pegilodecakin plus Pembrolizumab; Pembrolizumab Alone
Intervention MeSH terms: Pembrolizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To compare the efficacy of pegilodecakin in combination with pembrolizumab versus
      pembrolizumab alone in participants with metastatic non-small cell lung cancer as measured by
      objective response rate.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participants must have histologically or cytologically confirmed WT NSCLC that is
             stage IV / metastatic or recurrent

          2. Participants with tumor tissue high expression of PD-L1 as defined by Tumor Proportion
             Score (TPS) ≥ 50%

          3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          4. Participants with measurable disease by spiral CT or MRI per RECIST v.1.1 criteria.

          5. Participants that have completed prior radiotherapy or radiosurgery at least 2 weeks
             prior to randomization.

          6. Participants must be naïve to therapy for the advanced stage of the disease. Previous
             neoadjuvant or adjuvant therapy is allowed for participants who successfully underwent
             complete radical surgery and ONLY if the last treatment was administered more than 12
             months prior to the start of the trial treatment

        Exclusion Criteria:

          1. Participants with active central nervous system (CNS) metastases or carcinomatous
             meningitis

          2. Participants with any serious or uncontrolled medical disorder or active infection
             with the hepatitis virus or the human immunodeficiency virus (HIV)

          3. Participants with Grade 1 (NCI-CTCAE v.4.03) toxicities attributed to prior
             anti-cancer therapy other than alopecia and fatigue prior to randomization

          4. Participants that have received pembrolizumab

          5. Participants with a history of severe hypersensitivity reactions to monoclonal
             antibodies

          6. Pregnant or lactating women

          7. Participants receiving any investigational agent within 28 days of first
             administration of trial treatment

          8. Participants that have received therapy with anti-tumor vaccines or other
             immunostimulatory antitumor agents

          9. Participants that have received therapy with anti-PD-1, anti-PD-L1, anti-PD-L-2,
             anti-CD-137, and/or anti CTLA-4 antibodies
Robots Paired With tDCS in Stroke Recovery
Condition: Stroke
MeSH terms: Stroke
Intervention: Transcranial Direct Current Stimulation (tDCS); Placebo sham
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Stroke; Cerebrovascular Accident; Cerebral Stroke; CVA; Robotic therapy; Upper extremity recovery; tDCS; Non-invasive brain stimulation

Summary:

      The purpose of this study is to evaluate if multiple therapy sessions of Transcranial Direct
      Current Stimulation (tDCS non-invasive brain stimulation) combined with robotic arm therapy
      lead to a greater functional recovery in upper limb mobility after stroke than that provided
      by robotic arm therapy alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older

          -  First single focal unilateral lesion with diagnosis verified by brain imaging, which
             occurred at least 6 months prior

          -  Cognitive function sufficient enough to understand experiments and follow instructions

          -  Fugl-Meyer assessment of 7 to 58 out of 66 (neither hemiplegic nor fully recovered
             motor function in the muscles of the shoulder, elbow, and wrist)

        Exclusion Criteria:

          -  Botox treatment within 6 weeks of enrollment

          -  Fixed contraction of the affected limb

          -  Complete flaccid paralysis of the affected limb

          -  History of hemorrhagic stroke

          -  Ongoing use of CNS active medications

          -  Ongoing use of psychoactive medications

          -  Presence of additional potential tDCS/TMS risk factors including damaged skin at site
             of stimulation, presence of a magnetically/mechanically active implant, metal in the
             head, family history of epilepsy, and personal history of seizures
A Study of CCX140-B in Subjects With Primary FSGS and Nephrotic Syndrome
Condition: Focal Segmental Glomerulosclerosis
MeSH terms: Nephrotic Syndrome; Nephrosis; Glomerulosclerosis, Focal Segmental
Intervention: CCX140-B
Intervention description: Orally administered tablet
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Sequential Assignment
Intervention model description: Open-Label, Intra-Subject, Dose Escalation
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: FSGS; Glomerulosclerosis; Proteinuria

Summary:

      An Open Label, Intra-Subject Dose Escalation Study of CCX140 B in Subjects with Primary FSGS
      and Nephrotic Syndrome
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subjects aged 18 years and older

          2. Primary FSGS based on renal biopsy findings consistent with FSGS and based on
             presentation of histopathology, medical history and clinical course OR subjects with
             genetic risk factors with presentations that are otherwise consistent with primary
             FSGS

          3. Urinary total protein:creatinine ratio (UPCR) ≥ 3.5 g protein/g creatinine at
             screening

        Exclusion Criteria:

          1. Pregnant or nursing

          2. History of organ transplantation, including renal transplantation

          3. Currently on an organ transplant waiting list or there's a reasonable possibility of
             getting an organ transplant within 6 months of screening

          4. Histological FSGS subtype of collapsing variant

          5. Subjects who initiated, discontinued or changed dose of anti-CD20 monoclonal
             antibodies within 16 weeks (4 months) prior to screening are excluded. Subjects who
             initiated treatment with anti-CD20 monoclonal antibodies >16 weeks (4 months) prior to
             screening are permitted if deemed safe by the investigator and only if they intend to
             remain on continued, unchanged therapy at a dosing interval that has been documented
             to achieve continuous B cell depletion for the given patient.

          6. Subjects who discontinued Rituximab or other anti-CD20 monoclonal antibodies >16 weeks
             (4 months) prior to screening without confirmed recovery of CD20+ B cell population to
             within normal range are excluded. Subjects who discontinued rituximab or other
             anti-CD20 monoclonal antibodies >16 weeks (4 months) prior to screening with confirmed
             recovery of CD20+ B cell population to within normal range are permitted in the study.
             UPCR and other urine protein assessments up to 1 year prior to screening (if
             available) that were performed in these patients as part of the clinical routine
             should be recorded in the medical history.

          7. Body Mass Index (BMI) ≥ 40
A Study of MM-121 in Combination With Chemotherapy Versus Chemotherapy Alone in Heregulin Positive NSCLC
Condition: Non-Small Cell Lung Cancer; NSCLC; Adenocarcinoma; Heregulin
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: MM-121; Docetaxel
Intervention description: Investigational, fully human antibody targeting and inhibiting ErbB3; approved chemotherapy treatment for NSCLC
Intervention MeSH terms: Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Randomized, open-label, international, multi-center, Phase 2 study in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)
Masking: None (Open Label)
Enrollment: 153.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: NSCLC; Non-Small Cell Lung Cancer; heregulin; ErbB3; docetaxel

Summary:

      The purpose of this study is to determine whether the combination of MM-121 plus docetaxel is
      more effective than docetaxel alone in regards to PFS in patients with heregulin-positive
      NSCLC.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a diagnosis of cytologically or histologically documented adenocarcinoma
             of the lung with either metastatic disease (stage IV), Stage IIIB or Stage IIIC
             disease not amenable to surgery with curative intent

          -  Not received more than 2 prior systemic therapies- one of which must have been a
             platinum based regimen- for primary or recurrent disease

          -  Tissue submitted for HRG-biomarker testing

          -  ECOG performance status (PS) of 0 or 1

        Exclusion Criteria:

          -  Known ALK mutation

          -  Presence of exon 19 deletion or exon 21 (L858R) substitution of the EGFR gene

          -  Received >2 prior systemic anti-cancer drug regimen for locally advanced disease

          -  Prior treatment with an anti-ErbB3 antibody

          -  CTCAE grade 3 or higher peripheral neuropathy

          -  Symptomatic CNS metastases or CNS metastases requiring steroids

          -  Any other active malignancy requiring systemic therapy

          -  Clinically significant cardiac disease
The Effect of an Antibiotic on the Production of Uremic Toxins by the Gut Microbiome
Condition: End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Intervention: Vancomycin; Placebo
Intervention description: Oral vancomycin 250mg capsules; Placebo Pills distributed by Research Pharmacy labeled "placebo."
Intervention MeSH terms: Vancomycin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: randomized double-blinded placebo-controlled crossover study
Masking: Double (Participant, Care Provider)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if multiple doses of vancomycin over the course of
      3 months will perturb the intestinal flora (microbiome) and result in reduced serum
      concentration of the uremic toxin indoxyl sulfate and p-cresyl sulfate. The design of the
      study will permit investigators to assess the variability of serum uremic retention solute
      concentrations with and without antibiotic over a three-month period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with stable chronic kidney disease on hemodialysis with a fistula or an AV
             graft.

        Exclusion Criteria:

          -  Antibiotics received within the last 3 months;

          -  recent diarrhea

          -  known allergy to vancomycin

          -  history of C. difficile infection

          -  elevation of white blood cell count or fever within one week of enrollment.
FLT PET Imaging for Cervical Cancer
Condition: Uterine Cervical Neoplasms
MeSH terms: Uterine Cervical Neoplasms
Intervention: [F18]Fluorothymidine
Intervention description: FLT PET scan 5 mCi (+/- 10%)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Positron-Emission Tomography; Radiotherapy, Intensity-Modulated

Summary:

      Our primary hypothesis is that [18F]FLT PET can identify active bone marrow in addition to
      metabolically active tumor.

      This trial will use FLT-PET imaging to define areas of active bone marrow in the pelvis. The
      radiation plan is then designed to spare that area, in hopes of keeping the bone marrow
      active during therapy. Bone marrow and tumor activity will be monitored using a sequence of
      FLT PET scans during the course of chemotherapy and radiation therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability to understand and willingness to sign a written informed consent document.

          -  Histologically confirmed stage IB2, IIA, IIB, IIIB, and IVA squamous cell carcinoma of
             the cervix.

          -  Scheduled to receive chemo-radiation for oncologic treatment.

          -  Karnofsky of at least 60 at time of screening

          -  Life expectancy of at least 6 months.

          -  Leukocytes at least 3,000/microL

          -  absolute neutrophil count at least 1,500/microL

          -  platelets at least 100,000/microL

          -  total bilirubin at maximum 1.0 mg/dL (UIHC limit of normal)

          -  either ALT or AST less than 2.5 times the upper limit of normal

          -  creatinine less than 1.5 times the upper limit of normal

          -  non-pregnant, non-nursing, willing to use contraception

        Exclusion Criteria:

          -  oncology research protocol requiring full pelvic radiation (i.e., 4-field box
             technique) or experimental chemotherapy

          -  uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             the study requirements.

          -  subjects taking nucleoside analog medications such as those used as antiretroviral
             agents.

          -  patients who have undergone hysterectomy or will have a hysterectomy as part of their
             cancer therapy.
A Study to Assess Long-term Safety, Tolerability and Efficacy of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Condition: Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
MeSH terms: Polyradiculoneuropathy; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Intervention: Rozanolixizumab
Intervention description: Subjects will receive rozanolixizumab in a specified sequence during the treatment period.
Intervention MeSH terms: Rozanolixizumab
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: Chronic inflammatory demyelinating polyradiculoneuropathy; CIDP; UCB7665; rozanolixizumab

Summary:

      The purpose of the study is to assess long-term safety and tolerability of weekly doses of
      rozanolixizumab in subjects with chronic inflammatory demyelinating polyradiculoneuropathy
      (CIDP).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject who has completed one of the previous rozanolixizumab study(ies) that allow
             access to the present study (e.g. study CIDP01)

          -  Female subjects of childbearing potential must agree to use a highly effective method
             of birth control, during the study and for a period of 3 months after their final dose
             of investigational medicinal product (IMP)

          -  Male subjects with a partner of childbearing potential must be willing to use a condom
             when sexually active during the study and for 3 months after the final administration
             of IMP

        Exclusion Criteria:

          -  Subject has any medical (acute or chronic illness) or psychiatric condition that, in
             the opinion of the investigator, could harm the subject or would compromise the
             subject's ability to participate in this study

          -  Subject has a clinically relevant active infection (eg, sepsis, pneumonia, abscess)

          -  Subject has a known hypersensitivity to any components of rozanolixizumab

          -  Subject intends to have a live vaccination during the course of the study or within 7
             weeks following the final dose of rozanolixizumab

          -  Subject has an ongoing serious adverse event (SAE) or a medical condition in the
             parent study that the investigator considers to put the subject at a significantly
             increased risk of participating in CIDP04

          -  Subject has any planned elective surgery due to occur during the study dosing period
             which in the opinion of the investigator could interfere with study procedures