bioihbjkbjnl/mcl2 huggingface dataset:
A Study of R1507 in Combination With Letrozole in Postmenopausal Women With Advanced Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: RG1507; Letrozole
Intervention description: R1507 was administered at a dose 16 mg/kg every 3 weeks.; Letrozole was administered orally at a dose 2.5 mg daily.
Intervention MeSH terms: Letrozole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study aim was to determine the safety and efficacy of R1507 in combination with
      letrozole in patients with advanced breast cancer. In the first part of the study a cohort of
      patients with advanced breast cancer received letrozole 2.5mg po daily in combination with
      R1507 16mg/kg every 3 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  postmenopausal female patients;

          -  stage IV or locally advanced breast cancer;

          -  measurable disease;

          -  letrozole failure (Part 2);

          -  Eastern Cooperative Oncology Group (ECOG) performance status <=2.

        Exclusion Criteria:

          -  previous chemotherapy for metastatic breast cancer;

          -  concurrent antibody or immunotherapy for advanced disease, within 4 weeks prior to
             receipt of study drug;

          -  history of primary malignancy in 5 years prior to study, excluding adequately treated
             basal or squamous cell cancer of skin, or cancer in situ of cervix;

          -  concurrent radiotherapy, or radiotherapy within 28 days prior to receipt of study
             drug.
A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Generalized Pustular Psoriasis
Condition: Generalized Pustular Psoriasis
MeSH terms: Psoriasis
Intervention: Imsidolimab
Intervention description: Humanized monoclonal antibody
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
Maximum age: 75 Years
Healthy volunteers: No
Keywords: GPP

Summary:

      The main objectives of this study are to evaluate the efficacy, safety and tolerability of
      imsidolimab in adults with active GPP.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of active GPP

          -  Japanese Dermatology Association (JDA) severity index total score of at least 6 and
             erythema with pustules accounting for at least 10% of body surface area or a moderate
             severity score on Generalized Pustular Psoriasis Physician's Global Assessment
             (GPPPGA)

          -  Must be candidates for systemic therapy or phototherapy

        Exclusion Criteria:

          -  Erythrodermic, guttate psoriasis, drug induced GPP

          -  Any other ongoing inflammatory disease that interfere with the Investigator's ability
             to evaluate the subject's response to therapy

          -  History of recurrent or chronic infection

          -  ongoing use of psoriasis prohibited medication

        Other protocol-defined inclusion/exclusion criteria may apply
DaxibotulinumtoxinA for Injection for the Treatment of Plantar Fasciitis
Condition: Plantar Fasciitis
MeSH terms: Fasciitis; Fasciitis, Plantar
Intervention: DAXI 80 U; DAXI 120 U; Placebo
Intervention description: DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) with 80 U (Low Dose Group); DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) 120 U (High Dose Group); Placebo is a sterile lyophilized product consisting of inactive ingredients without the neurotoxin to be reconstituted with sterile, non-preserved 0.9% sodium chloride solution.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomly assigned to 1 of 3 treatment groups: DAXI for injection LOW dose, DAXI for injection HIGH dose, Placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double Blinded
Enrollment: 155.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: DAXI for injection,; Plantar Fasciitis,; Heel Pain,; BotulinumtoxinA

Summary:

      This is a randomized, double-blind, placebo-controlled, parallel group, multi-center trial of
      a single administration of DaxibotulinumtoxinA (DAXI) (high-dose; low-dose) for injection
      versus placebo for the management of Plantar Fasciitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent, including authorization to release health information.

          -  Male or female subjects 18 to 65 years of age with diagnosis of unilateral plantar
             fasciitis.

          -  Persistent heel pain.

          -  Women of child bearing potential must have a negative pregnancy test at Screening and
             Injection Visits and must use an effective method of contraception during the course
             of the study.

        Exclusion Criteria:

          -  Previous injection of botulinum toxin in the lower extremities or feet.

          -  Previously suffered a partial or full thickness tear or surgery of the plantar fascia
             within the 5 years preceding participation in the investigation.

          -  Pregnant, nursing, or planning a pregnancy during the study.

          -  Current enrollment in an investigational drug or device study or participation in such
             a study within the last 30 days prior to first visit.

          -  Any condition or situation which, in the Investigator's opinion, puts the subject at
             significant risk, could confound the trial results, or may interfere significantly
             with the subject's participation in the trial.
MagnetisMM-3: Study Of Elranatamab (PF-06863135) Monotherapy in Participants With Multiple Myeloma Who Are Refractory to at Least One PI, One IMiD and One Anti-CD38 mAb
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Elranatamab (PF-06863135)
Intervention description: BCMA-CD3 bispecific antibody
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 187.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Myeloma; Multiple Myeloma; relapsed Multiple Myeloma; refractory Multiple Myeloma; PF-06863135; BCMA; bispecific; bispecific antibody; BCMA-CD3 bispecific; Elranatamab; MagnetisMM-3

Summary:

      The purpose of the study is to evaluate whether single-agent Elranatamab (PF-06863135) can
      provide clinical benefit in participants with relapsed/refractory multiple myeloma.
      Elranatamab is a bispecific antibody: binding of Elranatamab to CD3-expressing T-cells and
      BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of multiple myeloma (IMWG criteria, Rajkumar et al, 2014)

          -  Measurable disease, as defined by at least 1 of the following:

               1. Serum M-protein >0.5 g/dL by SPEP

               2. Urinary M-protein excretion >200 mg/24 hours by UPEP

               3. Serum immunoglobulin FLC≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin
                  kappa to lambda FLC ratio

          -  Refractory to at least one IMiD

          -  Refractory to at least one PI

          -  Refractory to at least one anti-CD38 antibody

          -  Relapsed/refractory to last anti-myeloma regimen

          -  Cohort A: has not received prior BCMA-directed therapy

          -  Cohort B: has received prior BCMA-directed therapy (ADC or CAR T cells)

          -  ECOG performance status ≤2

          -  Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1

          -  Not pregnant and willing to use contraception

        Exclusion Criteria:

          -  Smoldering multiple myeloma

          -  Active Plasma cell leukemia

          -  Amyloidosis

          -  POEMS syndrome

          -  Stem cell transplant within 12 weeks prior to enrollment

          -  Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or
             viral infection

          -  Any other active malignancy within 3 years prior to enrollment, except for adequately
             treated basal cell or squamous cell skin cancer, or carcinoma in situ.

          -  Previous administration with an investigational drug within 30 days or 5 half-lives
             preceding the first dose of study intervention used in this study (whichever is
             longer)
Safety and Efficacy Following Repeat-Dose of Evinacumab (Anti-ANGPTL3) in Patients With Severe Hypertriglyceridemia (sHTG) at Risk for Acute Pancreatitis
Condition: Severe Hypertriglyceridemia (sHTG)
MeSH terms: Pancreatitis; Hypertriglyceridemia
Intervention: evinacumab; Placebo
Intervention description: Administered by Intravenous (IV); Administered by Intravenous (IV)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The primary objective is to determine the change in Triglyceride (TG) levels following 12
      weeks of repeated Intravenous (IV) doses of evinacumab.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Previous documentation in the patient's medical records of a fasting serum TG
             measurement ≥ 1000 mg/dL (11.3 mmol/L) on more than 1 occasion, and all fasting TG
             values ≥500 mg/dL (5.6 mmol/L) at screening

          2. History of a hospitalization and diagnosis of acute pancreatitis in the past 10 years

          3. On stable lipid-modifying diet with or without medications (eg, statins, niacin,
             omega-3 fatty acids). Lipid-modifying diet and doses of medications should be stable
             for at least 4 weeks (6 weeks for fibrates, 8 weeks for PCSK9 inhibitors) prior to
             screening

          4. Body mass index (BMI) of 18-40 kg/m2

        Key Exclusion Criteria:

          1. A hospital or clinic discharge diagnosis of acute pancreatitis within 12 weeks of
             screening

          2. Lipid apheresis or plasma exchange treatment within the last 4 weeks or plans to
             undergo apheresis or plasma exchange during the time frame of the study

          3. History of class 3/4 heart failure at any time in the past, or hospitalization for
             heart failure, diagnosis of a myocardial infarction, stroke, Transient ischemic attack
             (TIA), unstable angina, Coronary artery bypass surgery (CABG), Percutaneous coronary
             intervention (PCI), carotid surgery/stenting within 3 months before the screening
             visit

          4. History of bleeding disorders, esophageal varices, heparin induced thrombocytopenia,
             or contraindications to receiving heparin (eg, allergic reaction to heparin)

          5. Previous treatment with Glybera® in the past 5 years or treatment with lomitapide or
             mipomersen in the past 6 months

          6. Pregnant or breast feeding women

        Note: Other protocol defined Inclusion/Exclusion criteria may apply
Metronomic Therapy in Patients With Metastatic Melanoma
Condition: Metastatic Melanoma
MeSH terms: Melanoma
Intervention: vinblastine; Cyclophosphamide; dacarbazine
Intervention description: 1 mg/m2 vinblastine given three times per week administered intravenously.; 60 mg/m2 cyclophosphamide taken orally every day for 3 weeks with one week rest; 15 mg/m2 dacarbazine given three times per week for 3 weeks with 1 week rest
Intervention MeSH terms: Cyclophosphamide; Dacarbazine; Vinblastine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metronomic Therapy; Metastatic Melanoma; Vinblastine; Cyclophosphamide; Dacarbazine

Summary:

      SUMMARY: Metronomic Therapy in Patients with Metastatic Melanoma: A Phase II Study of Low
      Dose Vinblastine, Cyclophosphamide, and Dacarbazine.

      Patients with measurable metastatic melanoma are eligible. All patients will be treated as
      outlined below with combined vinblastine, cyclophosphamide, and dacarbazine. Patients will be
      treated continuously, until evidence of progression of disease, or for up to two cycles
      following disappearance of all disease. A cycle will be defined as three weeks of continuous
      therapy with a one week rest.
    

Eligibility criteria:

        -  Metastatic melanoma with measurable disease

          -  Patients must be at least 4 weeks from their last immunotherapy, radiation, surgery or
             chemotherapy (6 weeks for nitrosoureas) and recovered from all ill

          -  Karnofsky Performance Status ≥60%

          -  Life expectancy ≥ twelve weeks

          -  Adequate end organ function

          -  Women should not be lactating and, if of childbearing age, have a negative pregnancy
             test within two weeks of entry to the study.

          -  Appropriate Contraception in both sexes

          -  The patient must be competent and signed informed consent.

        EXCLUSION CRITERIA

          -  Concomitant second malignancy except for non-melanoma skin cancer, and non-invasive
             cancer such as cervical CIS, superficial bladder cancer without local recurrence,
             breast CIS.

          -  In patients with a prior history of invasive malignancy, less than five years in
             complete remission.

          -  Have evidence of significant co-morbid illness such as uncontrolled diabetes -
             Uncontrolled brain metastasis: Patients with brain metastasis most have been treated
             with brain radiation therapy or surgery and remain clinically stable for a minimum of
             4 weeks.
Feasibility Trial of Intraperitoneal Chemotherapy for Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma
Condition: Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma; Uterine Cancer
MeSH terms: Carcinoma; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms; Uterine Neoplasms
Intervention: Paclitaxel, Cisplatin IP
Intervention description: Paclitaxel 135 mg/m2 IV (3-hr infusion) on Day 1, Cisplatin 50 mg/m2 IP on Days 1 and 8, Repeat every 3 weeks for 6 cycles
Intervention MeSH terms: Paclitaxel; Cisplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: Female
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma; Uterine Cancer; Intraperitoneal Chemotherapy; IP Chemotherapy; Gynecologic Cancer; Women's Cancer; Cisplatin; Paclitaxel; Recurrent Platinum Sensitive Ovarian Cancer

Summary:

      The purpose of this study is to evaluate giving chemotherapy drugs directly into the abdomen
      (belly) along with intravenous administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with stage IA, IB, IC, II, III, IV and recurrent platinum sensitive
             epithelial ovarian carcinoma, fallopian tube carcinoma, primary peritoneal carcinoma,
             or ovarian carcinosarcoma. Histologic subtypes which are eligible include serous
             adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated
             carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell
             carcinoma, malignant Brenner's tumor, adenocarcinoma (not otherwise specified), and
             carcinosarcoma.

          -  Patients with advanced endometrial carcinoma, of any histology, including endometrioid
             adenocarcinoma, clear cell adenocarcinoma, and serous papillary carcinoma.

          -  Patients with uterine carcinosarcoma of any stage are eligible.

        Exclusion Criteria:

          -  Patients with epithelial ovarian carcinoma of low malignant potential (borderline
             carcinomas).

          -  Patients with septicemia, severe infection, or acute hepatitis.

          -  Patients with prior malignancy or cancer treatment within the last five years.
Contezolid Acefosamil Versus Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infection
Condition: Skin Diseases, Bacterial; Gram-Positive Bacterial Infections
MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Skin Diseases, Bacterial; Gram-Positive Bacterial Infections; Skin Diseases
Intervention: contezolid acefosamil; linezolid 600 mg
Intervention description: IV and oral contezolid acefosamil given twice a day for 10 to 14 days; IV and oral linezolid given twice a day for 10 to 14 days
Intervention MeSH terms: Linezolid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 196.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ABSSSI; Acute bacterial skin and skin structure infection

Summary:

      The purpose of this study is to determine whether contezolid acefosamil is as safe and
      effective as linezolid in the treatment of adult patients with acute bacterial skin and skin
      structure infections
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with systemic signs of infection diagnosed with acute bacterial skin and skin
             structure infection (ABSSSI)

          -  Diagnosed with cellulitis/erysipelas, major cutaneous abscess, or wound infections

        Exclusion Criteria:

          -  Uncomplicated skin infections

          -  Severe sepsis or septic shock

          -  ABSSSI solely due to Gram-negative pathogens

          -  Prior systemic antibiotics within 96 hours of randomization
Phase II Clinical Trial of Intraoral Grafting of Human Tissue Engineered Oral Mucosa
Condition: Disorder of Oral Mucous Membrane
Intervention: EVPOME (autogenous ex vivo produced oral mucosa equivalent); POM (Palatal oral mucosa)
Intervention description: EVPOME is manufactured from the subjects own oral cells and is implanted back in the subjects mouth after an approximately 30 day manufacturing process.; POM is a tissue graft harvested from the palate and surgically placed into the defect area
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: dental implants; deficient keratinized oral mucosa

Summary:

      The purpose of this study is to improve the current standard of care of repairing mouth soft
      tissue defects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Deficient band (<3mm) of keratinized mucosa prior to or following dental implant
             placement

          -  Surgery to increase width of keratinized mucosa is clinically indicated or requested
             by the patient to facilitate oral hygiene procedures or to improve esthetics

          -  Patients in need of a graft of approximately 15 x 10 x 20 mm in dimension

        Exclusion Criteria:

          -  Subjects with potential medical complications such as evidence of clinically
             significant (as described by investigators) renal, hepatic, cardiac, endocrine,
             hematologic, autoimmune, or any systemic disease which may complication execution of
             the protocol and/or interpretation of results

          -  Current radiation therapy or history of radiation therapy treatment to the intraoral
             donor biopsy site or recipient site for graft placement

          -  Documented history of syphilis, HIV, Hepatitis B or C virus

          -  Pregnant women or women planning to become pregnant or unwilling to abstain or use
             double barrier contraceptives during the course of the study

          -  Smoking or use of tobacco products within 6 months prior to screening

          -  History of either alcohol or drug abuse

          -  Subjects taking medications that can result in gingival enlargement/overgrowth
             (Cyclosporine, Dilantin, calcium channel blockers)

          -  Current use of intravenous bisphosphonate or current oral bisphosphate use or a
             history of bisphosphonate use for over 5 years