bioihbjkbjnl/mcl2 huggingface dataset:
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 A Novel Compound For Excessive Daytime Sleepiness Associated With Narcolepsy
Condition: Excessive Daytime Sleepiness; Narcolepsy
MeSH terms: Narcolepsy; Disorders of Excessive Somnolence; Sleepiness
Intervention: Placebo; PF-03654746
Intervention description: Patients receiving placebo will undergo the same procedures as those receiving active treatment. Each patient will receive matching placebo tablets in a fixed dose escalation schedule beginning at 0.25 mg QD for 5 days; then up to 0.50 mg QD for another 5 days; and up to 1.0 mg QD for an additional 5 days. At the end of this fixed titration schedule, the patient will either stay at 1.0 mg; decrease to 0.5 mg or increase to 2.0 mg based upon the clinicians judgment regarding efficacy and side effects at the 1.0 dose level. The patient will then remain at the determined dose for a 3 week stable dosing period, with a 7 (-2/+ 9) day wash out and then crossover to repeat the same sequence for the second arm of the study.; Each patient will receive PF-03654746 tablets in a fixed dose titration schedule beginning at 0.25 mg QD for 5 days; then up to 0.50 mg QD for another 5 days; and up to 1.0 mg QD for an additional 5 days. At the end of this fixed titration schedule, the patient will either stay at the 1.0 mg dose; decrease to 0.50 mg or increase to 2.0 mg based upon the clinician's judgement regarding efficacy and side effects at the 1.0 mg dose. The patient will remain at the determined dose for a 3 week stable dosing period.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 95.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Randomized; double-blind; placebo-controlled; crossover study of PF-03654746 in Excessive Daytime Sleepiness associated with Narcolepsy

Summary:

      Histaminergic agents are known to be involved with the sleep/wake cycle. This compound is a
      histaminergic agent which therefore may improve alertness and awakeness in patients with
      excessive daytime sleepiness (EDS) associated with narcolepsy. Significant improvement in EDS
      when treated with this compound compared to placebo in patients with narcolepsy is
      hypothesized.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ISDC diagnosis of narcolepsy

          -  Excessive Daytime Sleepiness in association with a diagnosis of narcolepsy

          -  An MWT (Maintenance of Wakefulness Test) average sleep latency of under 15 minutes at
             Baseline

        Exclusion Criteria:

          -  No other diagnosed sleep disorders (e.g., sleep apnea)

          -  Major medical disorders

          -  Major psychiatric disorders
Hysteroscopic Lymphatic Mapping for Endometrial Cancer
Condition: Endometrial Cancer
MeSH terms: Endometrial Neoplasms
Intervention: Intraoperative Lymphatic Mapping
Intervention description: Intraoperative hysteroscopic injection of patent blue dye and radiocolloid for detection of sentinel lymph nodes.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: Female
Healthy volunteers: No
Keywords: Endometrial Cancer; Lymphatic Mapping; Sentinel Node Identification; Lymph Node; Intraoperative lymphatic mapping; Total hysterectomy; Bilateral salpingooophorectomy; Lymph node staging; Laparotomy; Laparoscopy

Summary:

      The goal of this clinical research study is to learn if a procedure called intraoperative
      (during surgery) lymphatic mapping can be used to find the sentinel lymph node in patients
      with endometrial cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with biopsy confirmed endometrial cancer who have been dispositioned to
             undergo total hysterectomy, bilateral salpingooophorectomy and lymph node staging.

          2. Surgical procedures may be performed by either laparotomy or laparoscopy.

          3. If computed tomography, magnetic resonance imaging, lymphangiography, or ultrasound
             has been performed for preoperative assessment, there must be no evidence of
             metastases. Imaging is not mandatory.

          4. Patients who have signed an approved informed consent and authorization permitting
             release of personal health information.

        Exclusion Criteria:

          1. Patients with a preoperative diagnosis of grade I endometrioid adenocarcinoma of the
             uterus.

          2. Patients with uterine papillary serous carcinoma.

          3. Patients who have undergone endometrial ablation or a myomectomy within 1 year of the
             surgery for endometrial cancer.

          4. Patients with known allergies to triphenylmethane compounds or technetium-99
             radiocolloid.

          5. Patients with a history of retroperitoneal surgery.

          6. Patients with a history of pelvic radiation.

          7. Patients with no lesion visible on hysteroscopy.

          8. Patients with previous exposure to the tracer (to prevent risk of allergic reaction).
Cardiac Electrophysiological Study
Condition: Atrial Flutter
MeSH terms: Atrial Flutter
Intervention: AZD1305
Intervention description: Intravenous infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 55.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to measure the effects of AZD1305 on cardiac electrophysiological
      properties and intracardiac pressures
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with atrial flutter (with a ventricular rate of <100 beats/minute at
             enrolment), scheduled for curative catheter ablation

          -  Sinus rhythm at randomisation

        Exclusion Criteria:

          -  QTc (Fridericia, QTcF ) >450 ms measured in sinus rhythm at randomisation,

          -  Serum potassium below 3.8 or above 5.0 mmol/L or plasma potassium below 3.6 or above
             5.0 mmol/L

          -  QRS duration >120 ms at randomisation
Pregabalin in Preventing Acute Pain Syndrome in Patients Receiving Paclitaxel
Condition: Pain; Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Acute Pain
Intervention: pregabalin; placebo; questionnaire administration
Intervention description: Given PO; Given PO; Ancillary studies
Intervention MeSH terms: Pregabalin
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized pilot clinical trial studies pregabalin in preventing acute pain syndrome in
      patients receiving paclitaxel. Pregabalin may control the pain caused by cancer treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > or equal to 18 years

          -  Ability to complete questionnaires by themselves or with assistance Paclitaxel at a
             dose of 80 mg/m^2 given, in the adjuvant setting, every week for a planned course of
             12 weeks without any other concurrent therapy

          -  Paclitaxel at a dose of 80 mg/m2 given, in the adjuvant (postoperative or
             neo-adjuvant) setting, every week for a planned course of 12 weeks without any other
             concurrent cytotoxic chemotherapy (trastuzumab and/or other antibody and/or small
             molecule treatment is allowed, except for PARP inhibitors).

          -  Life expectancy > 6 months

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

          -  Negative pregnancy test (serum or urine) done =< 7 days prior to registration, for
             women of childbearing potential only (per clinician discretion)

        Exclusion Criteria:

          -  Pregnant women

          -  Nursing women

          -  Men or women of childbearing potential who are unwilling to employ adequate
             contraception since this study involves agents that have known genotoxic, mutagenic
             and teratogenic effects

          -  Previous diagnosis of diabetic or other peripheral neuropathy

          -  Current, planned or previous use, within last 6 months, of gabapentin or pregabalin

          -  History of allergic or other adverse reactions to gabapentin or pregabalin

          -  Significant renal insufficiency with a history of a creatinine clearance (CrCL) <
             30ml/min

          -  Prior exposure to neurotoxic chemotherapy

          -  Seizure history

          -  Diagnosis of fibromyalgia

          -  Previous exposure to paclitaxel
Combination Chemotherapy in Treating Patients With Previously Untreated Stage II or Stage III Esophageal Cancer That Can Be Removed By Surgery
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Intervention: Docetaxel; Floxuridine; Leucovorin; Oxaliplatin; Microarray analysis; reverse transcriptase-polymerase chain reaction; Conventional surgery
Intervention description: Intravenously, 25 mg/m2, over 30 minutes, 2 cycles; Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles; Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles; Intravenously, 85 mg/m2, over 2 hours, 2 cycles; Analysis of tumor for pathologic response to protocol therapy; Analysis of tumor for pathologic response to protocol therapy; Surgical removal of tumor for correlative studies
Intervention MeSH terms: Leucovorin; Docetaxel; Oxaliplatin; Floxuridine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage II esophageal cancer; stage III esophageal cancer; adenocarcinoma of the esophagus

Summary:

      RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, floxuridine, docetaxel, and
      leucovorin, work in different ways to stop the growth of tumor cells, either by killing the
      cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)
      may kill more tumor cells. Giving chemotherapy before surgery may make the tumor smaller and
      reduce the amount of normal tissue that needs to be removed.

      PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating
      patients with previously untreated stage II or stage III esophageal cancer that can be
      removed by surgery.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of adenocarcinoma of the esophagus meeting the following criteria:

               -  Stage II or III disease

               -  Resectable disease

               -  Previously untreated disease

          -  No stage I (mucosal only) or stage IV (metastatic) disease

        PATIENT CHARACTERISTICS:

          -  WBC > 3,000/mm^3

          -  Absolute neutrophil count > 1,500/mm^3

          -  Platelet count > 100,000/mm^3

          -  Creatinine ≤ 2.0 mg/dL

          -  Bilirubin < 2 times normal

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Must have central venous access

          -  No other malignancy within the past 5 years

          -  No concurrent medical or psychiatric problem that would preclude study treatment

          -  No contraindications to paclitaxel

        PRIOR CONCURRENT THERAPY:

          -  No prior chemotherapy or radiotherapy to the esophagus

          -  No oral cryotherapy (e.g., ice chips) on day 1 of each course
Study of IMO-2055 in Metastatic or Locally Recurrent Clear Cell Renal Carcinoma
Condition: Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell; Kidney Neoplasms
Intervention: IMO-2055
Intervention description: immunostimulatory oligonucleotide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 92.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: renal; cell; renal carcinoma; metastatic; recurrent; treatment naive

Summary:

      -  Multi-Center

        -  Randomized

        -  Open-Label Study of single agent IMO-2055

        -  Patients who have Metastatic or Locally Recurrent Clear Cell Renal Carcinoma (RCC)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed stage IV clear cell renal carcinoma with metastatic or
             locally recurrent disease that is not surgically resectable.

          -  At least one measurable lesion

          -  Adequate organ function

          -  Any prior treatment of renal cell cancer was concluded at least 4 weeks prior.

          -  If female and of childbearing potential, a negative serum pregnancy test performed and
             documented no more than 14 days before the first dose of study drug.

        Exclusion Criteria:

          -  Known untreated central nervous system (CNS) metastasis

          -  Pre-existing autoimmune or antibody-mediated diseases

          -  Other significant medical disease.
ValGanciclovir Versus ValAcyclovir for Viral Prophylaxis in Kidney Transplantation
Condition: Transplantation Infection; Epstein-Barr Virus Infections; Cytomegalovirus Infections
MeSH terms: Infections; Communicable Diseases; Cytomegalovirus Infections; Epstein-Barr Virus Infections
Intervention: Valacyclovir; Valganciclovir
Intervention description: Experimental Arm; Standard of care
Intervention MeSH terms: Valacyclovir; Valganciclovir
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 137.0
Sex: All
Healthy volunteers: No
Keywords: EBV; CMV; Kidney transplant; valganciclovir; valacyclovir

Summary:

      Our study will compare all kidney transplant recipients receiving valganciclovir vs.
      valacyclovir for one year following kidney transplant and compare:

        1. the incidence, magnitude and duration of CMV and EBV viremia in the first year after
           transplant.

        2. the side effects of the anti-viral drugs requiring dose reduction or cessation

      In addition, we will test renal tissue obtained from any biopsies post-transplant
      (surveillance or clinically indicated biopsies) by both polymerase chain reaction (PCR) and
      fluorescence in situ hybridization to assess for latent CMV and/or EBV.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All consenting kidney transplant recipients.

        Exclusion Criteria:

          -  Non-consent.

          -  Recipients with allergies to valacyclovir or valganciclovir

          -  Recipients that are unable to independently understand the consent form and do not
             have a legally authorized representative.
The Tolerability and Effects of AZD8848 in Allergic Asthma Subjects Challenged With Inhaled Allergen
Condition: Allergic Asthma
MeSH terms: Asthma
Intervention: AZD8848; Placebo
Intervention description: Nasal spray, solution 0.6mg/ mL. Once weekly for 7 weeks, 8 doses in total.; Nasal spray, solution. Once weekly for 7 weeks, 8 doses in total.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      AZD8848 is a new drug that is being tested for the treatment of asthma and allergic rhinitis
      (hayfever). This study will be in two parts and will include 59 asthmatic patients in total.
      The first part will investigate the tolerability and safety of AZD8848 while the second part
      will investigate both the therapeutic effect of AZD8848 and how well patients tolerate the
      drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  FEV1 > 70 % of predicted normal pre-bronchodilator

          -  Documented history of asthma

          -  Presence of allergic sensitivity

        Exclusion Criteria:

          -  Clinically relevant disease and/or abnormality (past or present), which, in the
             opinion of the Investigator, may either put the patient at risk because of
             participation in the study, or influence the results of the study, or the patient's
             ability to participate in the study.

          -  Symptomatic allergic rhinitis

          -  Any clinical relevant abnormal findings in physical examination or assessment which
             may put the patient at risk because of participation in the study
Denosumab for Prevention of Post-Teriparatide Bone Loss in Premenopausal Women With IOP
Condition: Adult Idiopathic Generalized Osteoporosis
MeSH terms: Osteoporosis
Intervention: Denosumab
Intervention description: Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months
Intervention MeSH terms: Denosumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: Female
Minimum age: 20 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: osteoporosis; premenopausal; denosumab; idiopathic; Idiopathic Osteoporosis in Premenopausal Women

Summary:

      The purpose of this research study is to evaluate antiresorptive therapy with denosumab
      (Prolia) for prevention of bone loss after stopping teriparatide (TPTD) in premenopausal
      women with idiopathic osteoporosis.

      Premenopausal women who have received TPTD in the FDA Orphan Diseases Program-funded trial,
      "A Phase 2 Study of Teriparatide for the Treatment of Idiopathic Osteoporosis in
      Premenopausal Women" (NCT01440803) may be eligible to participate in the current study, a
      36-month open-label pilot study of denosumab (Prolia®, 60mg subcutaneous (SC) every 6
      months).

      The goals of the study are to estimate the effects of denosumab on central and peripheral, as
      well as trabecular and cortical, bone mass and microstructure and to obtain preliminary data
      to inform the design of a future randomized study. This study presents the first opportunity
      to study the effects of denosumab after TPTD in this unique and severely affected group of
      young women.

      Funding Source: FDA Office of Orphan Products Development (OOPD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  All women completing NCT01440803 who remain without a disease or medication that
             causes osteoporosis will be offered enrollment into this study.

          -  (Premenopausal status is no longer be required for entry.)

        Exclusion Criteria:

          -  Renal insufficiency or liver disease: Creatinine, transaminase (AST)/alanine
             transaminase (ALT) above upper limit of normal

          -  Vitamin D deficiency: 25-hydroxyvitamin D (25-OHD) <30 ng/mL

          -  Pregnancy: urine pregnancy test must be negative