Patients may not have current signs and/or symptoms of bowel obstruction within 1 month prior to starting study drugs, except if it was a temporary incident (improved within < 24 hours [hr] with medical management)
History of hemoptysis within the last 1 month
Severe, active co-morbidity defined as follows:\r\n* Current (within 28 days of cycle 1, day 1) signs and/or symptoms of bowel obstruction\r\n* Patients who require parental hydration and/or nutrition\r\n* Patients who require drainage gastrostomy tube\r\n* Evidence of bleeding diathesis or clinically significant coagulopathy\r\n* Serious, non-healing or dehiscing wound, active ulcer or untreated bone fracture\r\n* History of hemoptysis (>= 1/2 teaspoon of bright red blood per episode) within 1 month of study enrollment
At least a 6 month interval since completion of prior radiation
Treatment with radiation therapy or surgery within one month prior to study entry.
History of hemoptysis (>= 1/2 teaspoon of bright red blood per episode) within 1 month prior to day 1
Low grade NHL: with < 6 month duration of CR between courses of conventional therapy
Fungal infections with radiological progression after receipt of amphotericin B or active triazole for greater than 1 month
Patients should have been off other investigational therapy for one month prior to receiving treatment on this study
Subjects must have at least one of the following indications for treatment: \r\n* Symptomatic or progressive splenomegaly\r\n* Symptomatic lymph nodes, nodal clusters, or progressive lymphadenopathy\r\n* Progressive anemia (hemoglobin =< 11 g/dL)\r\n* Progressive thrombocytopenia (platelets =< 100 x 10^9/L)\r\n* Weight loss > 10% body weight over the preceding 6 month period\r\n* Fatigue attributable to CLL\r\n* Fever or night sweats for > 2 weeks without evidence of infection\r\n* Progressive lymphocytosis with an increase of > 50% over a 2-month period or an anticipated doubling time of less than 12 months
Have participated in another therapeutic clinical trial with an investigational drug within 1 month
Has developed chest pain in the past month
Blood (packed red blood cells, platelets) transfusions within 1 month prior to study start
Variceal bleeding within 1 month prior to study registration
Treatment with major surgery (requiring general anesthesia) within one month prior to study entry
Patients who are currently part of or have participated in any clinical investigation with an investigational drug within 1 month prior to dosing
TREATMENT: Patients should have been off other investigational therapy for one month prior to entry in this study
Patients should have been off other investigational therapy for one month prior to entry in this study
Patients with fungal pneumonia with radiological progression after receipt of amphotericin formulation or mold-active azoles for greater than 1 month will not be eligible for this protocol
Patients should have been off other investigational therapy for one month prior to receiving treatment on this study
Predisposing characteristics for acute pancreatitis in the last month prior to randomization.
documented as surgically sterilized (at least 1 month prior to the screening visit)
Patient with irregular cycles (more than once a month)
Participant who is breastfeeding or planning to breastfeed for a month post last dose of study agent
Inability to start the protocol treatment within 1 month after study enrollment
Administration of chemotherapy within the last 1 month
Patients must have had no radiotherapy, immunotherapy, chemotherapy or therapy with targeted agents within the last 1 month
Patients who have had prior chemotherapy, immunotherapy, targeted therapy, or radiotherapy within 1 month of enrollment
Male patients must use a form of barrier pregnancy prevention approved by the investigator / treating physician during the study and for at least one month after treatment discontinuation (site-specific criteria applying to Avera only)
No other investigational anti-neoplastic therapy for one month prior to entry in this study
No other investigational anti-neoplastic therapy for one month prior to entry in this study
Concurrent osteoclast-inhibitory therapies (zoledronic acid, denosumab) are permitted if patients have been on a stable dose for at least 1 month
History of active immunotherapy in the previous month.
Progressive lymphocytosis with > 50% increase over a 2-month period, or anticipated doubling time < 6 months.
Prior external beam radiation therapy to the target lesion(s) within 1 month prior to enrollment
Prior systemic chemotherapy or therapy with one of the investigational agents within 1 month prior to enrollment
Patients should have been off other investigational therapy for one month prior to entry in this study
Subjects must have at least one of the following indications for treatment: \r\n* Symptomatic or progressive splenomegaly\r\n* Symptomatic lymph nodes, nodal clusters, or progressive lymphadenopathy\r\n* Progressive anemia (hemoglobin =< 11 g/dL)\r\n* Progressive thrombocytopenia (platelets =< 100 x 109/L)\r\n* Weight loss > 10% body weight over the preceding 6 month period\r\n* Fatigue attributable to CLL\r\n* Fever or night sweats for > 2 weeks without evidence of infection\r\n* Progressive lymphocytosis with an increase of > 50% over a 2-month period or an anticipated doubling time of less than 12 months
Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab)
off other investigational therapy for one month prior to entry in this study.
No prior radiation therapy or chemotherapy within 1 month of study enrollment
No other investigational antitumor therapy for one month prior to entry in this study
Active or recent (prior 6 month) invasive fungal infection without interdisciplinary (ID) consult and approval
Subject had surgery (excluding line insertions) within 1 month of the first dose of study drug or has lingering wound complications.
Use of illicit drugs in the last month (marijuana, cocaine, opiates, benzodiazepines, methamphetamine)
Patients cannot be on a targeted agent (e.g., sunitinib or everolimus) or receiving cytotoxic chemotherapy (e.g., capecitabine or temozolomide); they can’t be on telotristat ethyl; previous use is acceptable if the patient has been off for over one month
History of pulmonary hemorrhage/hemoptysis >= grade 2 (defined as >= 2.5 mL bright red blood per episode) within 1 month prior to randomization.
Packed red blood cell transfusions or erythropoietin therapy within 14 days prior to the study enrollment unless erythropoietin therapy has been used to maintain a stable condition for at least 1 month prior to the enrollment
Rx with an investigational drug w/in 1 month of infusion, other than for treatment of their underlying disease
History of bowel obstruction within 1 month prior to starting study drugs
History of hemoptysis within the last 1 month prior to randomization
Chronic opioid use defined as daily opioid use for more than one month prior the scheduled date of surgery.
Clinically relevant infection of any kind within the month preceding enrollment (example, active hepatitis C, pneumonia)
Participation in another clinical study involving an investigational product within 1 month before study entry;
Brain MRI within one month prior to enrollment
Low grade NHL–with < 6 month duration of CR between courses of conventional therapy
Fungal infections with radiological progression after receipt of amphotericin B or active triazole for greater than 1 month
Patients who have had influenza, hepatitis, or other vaccines within a month prior to initiation of study drugs
Corticosteroids will be allowed at enrollment and during the first month of treatment with T-DM1 after SRS, up to a dose of no more than 10 mg of dexamethasone daily or equivalent; patients that need to continue corticosteroids after the initial month will be allowed to continue in the protocol treatment if no further increase in dose is necessary; patients that need increase in dose of corticosteroid after initial month will be taken off protocol treatment
Patients who have any liver metastases or visceral metastasis of ? 3 cm, plus evidence of progression meeting irRC 1.0 within 1 month before the first OBP-301 administration.
(Bevacizumab-related exclusion) History of hemoptysis (>= 1/2 teaspoon of bright red blood per episode) within 1 month of study enrollment for any tumor type
History of hemoptysis (>= 1/2 teaspoon of bright red blood per episode) within 1 month of study enrollment
Participation in another clinical study with an investigational product during the last 1 month prior to initiation of therapy
Resident in the area and willing to attend up to 7 clinic visits for a 36-month period at the Virology Research Clinic (VRC)
Chemotherapy (current, within the last month, or anticipated in the next 7 months)
Participation in another clinical study with an investigational product during the last 1 month
History of bowel obstruction within 1 month prior to starting study drugs
History of hemoptysis or any significant bleeding within the last 1 month prior to enrollment
Radiation therapy in the month prior to enroll
Treatment with radiation therapy, surgery, or investigational therapy within one month prior to registration
Patients who, in the estimation of the treating physician or primary investigator, have had a clinical deterioration of their ECOG performance within the month prior to enrollment
Received systemic treatment for cancer, including immunotherapy, within one month prior to initiation of dosing within this protocol
Refractory to prior brentuximab vedotin (defined as developing progressive disease while on treatment or progressed within 3 month of finished last dose of brentuximab vedotin)
The subject has a prior history of unrelated neoplastic disease, and has received systemic therapy for the secondary malignancy within the twelve (12) month period preceding the screening evaluation
No history of prolonged QTC or cardiomyopathy unless normal QTC and ejection fraction confirmed within 1 month prior to study entry
Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to one month prior to or after any dose of ipilimumab)
Disease staging approximately within one month of treatment
History of pulmonary hemorrhage/hemoptysis >= grade 2 (defined as >= 2.5 mL bright red blood per episode) within 1 month prior to on-study date
Radiation therapy in the month prior to enrollment
Surgeon's estimated survival >= 1 month
Estimated survival < 1 month
Patients receiving anti-coagulation therapy are eligible as long as anti-coagulation regimen has been stable for > 1 month
Illicit drug use within the last month
Patients who are currently part of or have participated in any clinical investigation with an investigational drug within 1 month prior to dosing
Is in an immunosuppressed state (e.g. HIV +, use of chronic steroids [> 1 month])
Patients who are currently part of or have participated in any clinical investigation with an investigational drug within 1 month prior to dosing (except ALK inhibitors)
Progressive lymphocytes with an increase of >= 50% over a 2-month period or an anticipated doubling time of less than 6 months OR
TREATMENT: Patients should have been off other investigational therapy for one month prior to entry in this study
PART 2: Active or recent (prior 6 month) invasive fungal infection without infectious disease (ID) consult and approval
Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to one month prior to or after any dose of ipilimumab)
Patients with myelodysplastic syndromes refractory (primary or acquired resistance) to hypomethylating agents; at least 4 1-month cycles of prior decitabine or SGI-110 (guadecitabine) OR 6 1-month cycles of 5-azacytidine (intravenous [IV], subcutaneous, or oral) is required unless the patient has progressive disease prior to completing the required number of cycles
Patients who have had flu, hepatitis, or other vaccines within a month prior to initiation of study drugs
History of hemoptysis ( >= 1/2 teaspoon of bright red blood per episode) within 1 month prior to day 1
Patients who are currently part of or have participated in any clinical investigation with an investigational therapeutic drug within 1 month prior to dosing
Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab)\r\n* Subjects may receive flu vaccine at any time before or during the study
Concurrent uncontrolled medical illness that is deemed by the investigator to have potential to interfere with the delivery of chemotherapy for a six month time period
Patients who have previously taken omega-3 fatty acid within 1 month prior to study enrollment
Patients who have an uncontrolled infection (presumed or documented) with progression after appropriate therapy for greater than one month
Any non-oncology live vaccine therapy used for prevention of infectious diseases (for up to one month prior to or after any dose of ipilimumab).
Received systemic treatment for cancer, including immunotherapy, within one month prior to initiation of dosing within this protocol; however, cell harvesting by leukapheresis may be performed before one month from prior therapy if the study investigators consider that it will not have a detrimental impact on the generation of the two cell therapies in this protocol
COHORT 3: ATOPIC DERMATITIS PATIENTS: Subjects with unstable or uncontrolled medical conditions that could require hospitalization during the initial month of the study or who have been hospitalized for treatment of these conditions in the one month prior to baseline sampling
Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab)
TIA or stroke in the last 1 month.
Use of oral glucocorticoids within 1 month of screening
Use of 5 alpha reductase inhibitor within 1 month of screening or total use, within the last two years prior to screening, of >3 months
History of hemoptysis (>= 1/2 teaspoon of bright red blood per episode) within 1 month prior to day 1 of FOLFIRI + bevacizumab initiation
Active pneumonia within 1 month prior to starting treatment
Received the last irradiated GM-CSF transfected allogeneic pancreatic cell lines Panc 10.05 and Panc 6.03 at least six months prior (+/- 1 month) (not applicable to the vaccine-naïve cohort patients)
Patients with fungal infection and radiological progression after receipt of amphotericin B or active triazole for greater than 1 month
Active or recent (prior 6 month) invasive fungal infection without infectious diseases (ID) consult and approval
Active or recent (prior 6 month) invasive fungal infection without infectious disease (ID) consult and approval
Received immunosuppression post hematopoietic transplant within 1 month of study entry
Clinically relevant infection of any kind within the month preceding enrollment (eg, active hepatitis C, pneumonia)
Clinically relevant infection of any kind within the preceding month of enrollment
Criteria 5 Prior therapy with carfilzomib is allowed as long as the patient had at least a PR to most recent therapy with carfilzomib, was not removed due to toxicity, did not relapse within 60 days from discontinuation of carfilzomib, and will have at least a 6-month carfilzomib treatment-free interval from last dose received until first study treatment. (Patients may receive maintenance therapy with drugs that are not proteasome inhibitors or CD38 antibodies during this 6-month carfilzomib treatment free interval)
recent (in the last 1 month prior to randomization) brain, spinal or ophthalmic surgery
Used any prescription medication during the prior 1 month that the investigator judges is likely to interfere with the study or to pose an additional risk to the patient in participating.
A history of events such as myocardial infarction, cerebrovascular accident or acute hepatitis within 3 months of randomization or treatment of a major active infection within one month of randomization, or any other significant event that in the opinion of the Investigator would preclude protocol therapy.
No non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab)
Treatment with radiation therapy or surgery within one month prior to study entry
TIA or stroke in the last 1 month
Radiation therapy in the month prior to enroll
Active or recent (prior 6 month) invasive fungal infection unless cleared by innovation and development (ID) consult
Anticipated lifespan greater than 3 month
Prior use of non-steroidal anti-androgens (e.g., bicalutamide, flutamide, nilutamide) within 1 month before registration
Subjects must have ended hormone replacement therapy (HRT) (e.g., conjugated estrogens tablets, USP, [Premarin]), at least 1 month (30 days) prior to receiving the first dose of randomized therapy
Current treatment with anti-androgen is allowed for a maximum of one month to prevent flare response with ADT
Progressive lymphocytosis with an increase of >50% over a 2-month period, or an anticipated doubling time of less than 6 months
History of hemoptysis (? 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1
Patients may not be receiving or have received any other investigational agents during or within 1 month prior to treatment with NFV
Patients must have received prior trastuzumab for > 2 month period before disease recurrence or recurrence or progression while on trastuzumab-based therapy
Patients with fungal pneumonia with radiological progression after receipt of amphotericin formulation or mold-active azoles for greater than 1 month will not be eligible for this protocol (either regimen A or B)
documented as surgically sterile (at least 1 month prior to Screening)
Anti-angiogenic therapy within the last month
Age < 18 years and > 1 month (< 1 month upon approval by Sponsor)
Patients with brain metastases that are untreated, symptomatic, or require therapy to control symptoms; or any radiation, surgery, or other therapy, including those used to control symptoms, within 1 month of first dose
Progressive lymphocytosis in the absence of infection, with an increase in blood Absolute Lymphocyte Count (ALC) >=50% over a 2-month period, or a lymphocyte doubling time (LDT) of <6 months (as long as initial ALC was >=30000/µl).
night sweats for > 1 month without evidence of infection
Subjects must be on therapy with bisphosphonate and denosumab. and are required to have been on such therapy for at least 1 month before start of study treatment.
Patients are excluded for any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab)
Fungal infections with radiological progression after receipt of amphotericin product or active triazole for > 1 month
Patients of fertile age who refuse contraception for a twelve month period post-transplant
Group 2 - Patients must have disease progression while on or within one month after CDK4/6 inhibitor based therapy
Fungal infections with radiological progression after receipt of amphotericin B or active triazole for greater than 1 month
History of hemoptysis (>= 1/2 teaspoon of bright red blood per episode) within 1 month of study enrollment for any tumor type
History of hemoptysis (>= 1/2 teaspoon of bright red blood per episode) or other significant spontaneous bleeding event within 1 month prior to day 1 of study drug or at any time on a prior VEGF inhibitor
Received systemic treatment for cancer, including immunotherapy, within one month prior to initiation of dosing within this protocol
Received systemic treatment for cancer, including immunotherapy, within one month prior to initiation of dosing within this protocol; however, cell harvesting by leukapheresis may be performed before one month from prior therapy if the study investigators consider that it will not have a detrimental impact on the generate of the two cell therapies in this protocol
Disease staging approximately within one month of treatment
Documented surgically sterile or status posthysterectomy (at least 1 month prior to screening)
Patients who are currently part of or have participated in any clinical investigation with an investigational drug within 1 month prior to dosing
Any non-oncology vaccine therapy used for the prevention of infectious disease within 1 month before or after any ipilimumab dose
The subject must be willing to apply the medications twice daily for 1 month
History of myocardial infraction (MI) within 6 month prior to starting study treatment
Patients who are currently part of or have participated in any clinical investigation with an investigational drug within 1 month prior to dosing
Patients who are currently part of or have participated in any clinical investigation with an investigational drug within 1 month prior to dosing
Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab)
Patients who are currently part of or have participated in any clinical investigation with an investigational drug within 1 month prior to dosing
Any non-oncology vaccine therapy used for the prevention of infectious disease within 1 month before or after any ipilimumab dose
COHORT A: Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab); Note: inactivated vaccines are allowed at any time on study
COHORT B: Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab); Note: inactivated vaccines are allowed at any time on study
Anticipated lifespan greater than 6 month.
Patients may not be receiving or have received any other investigational agents during/or within 1 month prior to treatment with oregovomab or nelfinavir
Participants with metastases are excluded if their brain metastases are:\r\n* Symptomatic\r\n* Treated (e.g., surgery, radiation therapy) but not clinically and radiographically stable one month after therapy (as assessed by at least two distinct contrast enhanced MRI or CT scans over at least a one month period), OR\r\n* Asymptomatic and untreated but > 1 cm in the longest dimension
documented surgically sterile or status post hysterectomy (at least 1 month prior to Screening)
Having smoked at least one cigarette within 1 month of cancer diagnosis
Patient taking varenicline or bupropion within one month of study enrollment
Expected survival > 1 month
Any non-oncology vaccine therapy used for prevention of infectious diseases for up to 1 month before BPX-201
Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab)
History of uncontrolled arrhythmias; subjects with controlled atrial fibrillation for > 1 month prior to study enrollment are not excluded
History of hemoptysis (1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1.
Prior daily use of tadalafil or other long-acting phosphodiesterase-5 (PDE5) inhibitors for one month or greater
Active or recent (prior 6 month) invasive fungal infection without infectious disease (ID) consult and approval
Cancer vaccines and convection-enhanced therapies: interval >= 1 month before study enrollment
Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab)
Anticipated survival of less than 1 month
History of gastrointestinal (GI) bleeding (hemoptysis/melena/hematochezia, >= 1/2 teaspoon of bright red blood per episode) within 1 month prior to day 1
Subjects who received any investigational medication, prior local therapy for pancreas cancer , or any significant change in treatment within 1 month prior to screening
Use of systemic glucocorticoids such as prednisone or Decadron in the last month
Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab)
History of hemoptysis (>= 1/2 teaspoon of bright red blood per episode) within 1 month prior to day -3
Use of other non-steroidal anti-inflammatory drugs (such as ibuprofen) exceeding 4 days per month, in the prior 6 weeks.
Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab)
Participants may have received prior TKI therapy, however must be on a stable dose of their current TKI for at least one month prior to enrollment
For patients with MPN: On ruxolitinib for at least three months and on a stable dose for at least 1 month prior to enrollment and taking at least 5 mg twice daily of ruxolitinib
History of hemoptysis (>= 1/2 teaspoon of bright red blood per episode) within 1 month prior to day 1
History of uncontrolled hemoptysis (>= 1/2 teaspoon of bright red blood per episode) within 1 month prior to day 1
Fungal infections with radiological progression after receipt of amphotericin B or active triazole for greater than 1 month
History of hemoptysis (greater than or equal to 1/2 teaspoon of bright red blood per episode) within 1 month prior to day 1
If spinal metastases is within previously irradiated field, there must be a 6 month interval between prior radiation course and study registration
History of hemoptysis ( >= 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1
History of hemoptysis (>/=1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1.
Estimated >4 month survival probability.
Patients receiving anti-hypertensive medicines must be on a stable regimen for at least 1 month
Patients should have been off other investigational antiviral or antitumor therapy for one month prior to entry in this study
Low-grade NHL with < 6 month duration of CR between courses of conventional therapy
signed informed consent for the HIFU treatment study through the 12 month follow-up visit (7 visits) and then through the extended follow-up period of 5 years (4 additional visits);
Received any of the following within the specified time frame prior to the Month 1-Day 1 Visit:
Chemotherapy or investigational antineoplastic drug within 1 month of planned initiation of vaccine therapy
Receipt of treatment known to potentially affect the course of AA within last month
Patients, who in the opinion of the investigator, are unlikely to comply with follow-up visits or other study requirements; patients who are currently part of or have participated in any clinical investigation with an investigational drug within 1 month prior to dosing
Patients who are currently part of or have participated in any clinical investigation with an investigational drug within 1 month prior to dosing
History of hemoptysis (? 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1
Received thrombolytic agents w/in the previous month
History of hemoptysis (>= 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1
Investigational therapy less than one month prior to study entry
Prior treatment with any investigational drug, chemotherapy, or monoclonal antibody within the preceding 1 month
No seizures, focal weakness of any extremity (by neurologic exam), or stroke symptoms in the past month
Current (within last month) use of chemotherapy for breast or other malignancy
Recent (within last month) or current intensive manual lymphatic drainage (MLD) and/or short stretch bandage use
Venous thromboembolism within 1 month prior to signing ICF.
Patients with acute gastrointestinal bleeding within 1 month of study entry
History of expectoration of blood within 1 month prior to study start or blood clotting problems.
If patients have received radiation therapy, there must be a one-month washout period
Patients having received radiation therapy in the month prior to enrollment
More than one previous episode of CDAD in the 3-month period prior to randomization.
Documented evidence of disease progression during 6 month period prior to the time of enrollment
Progressive lymphocytosis, with an increase exceeding 50% over a 2 month period or a doubling time of less than 6 months.
Patients must show evidence of objective disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) 1 on scans within the 6 month period immediately preceding enrollment; both scans used to determine disease progression should have been obtained within this 6-month period
Prior therapy with Velcade is allowed as long as the patient had at least a PR to prior Velcade therapy, was not removed from Velcade therapy due to toxicity, and will have at least a 6 month Velcade treatment-free interval from last dose received until first study treatment. (Patients may receive maintenance therapy with drugs that are not in the proteasome inhibitor class during this 6 month Velcade treatment-free interval).
Prior therapy with carfilzomib is allowed as long as the patient had at least a PR to prior carfilzomib therapy, was not removed from carfilzomib therapy due to toxicity, and had at least a 6-month carfilzomib treatment-free interval from last dose received until first study treatment. (Patients may receive maintenance therapy with drugs that are not in the proteasome inhibitor class during this 6 month carfilzomib treatment-free interval). The exception to this is patients randomized or previously randomized in any other Onyx-Sponsored Phase 3 trial.
Chest X-ray within 1 month of registration
Patients in this study may not use vaccines for the treatment of cancer or prevention of disease unless indicated as a component of the protocol regimen (including those for common medical conditions) for up to one month pre and post dosing with ipilimumab
Male subjects who are sexually active must agree to use a condom from the beginning of treatment and for 1 month after the last dose
Traumatic catheterization within 1 month
History of hemoptysis (>= ½ teaspoon of bright red blood per episode) within 1 month prior to day 1
Glaucoma diagnosed within one month prior to study Day 1.
Treatment with highly active antiretroviral therapy (HAART) for at least 1 month
Patients that start chemotherapy or radiotherapy during the study time (1 month post diagnostic bronchoscopy), will be excluded from the study
Radiation therapy in the month prior to enroll
Documented surgically sterile or status post hysterectomy (at least 1 month prior to screening).
Patients with a history of more than two weeks treatment with immuno-suppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study
Smoked an average of less than 10 cigarettes per day during past month
Patient is currently receiving or has received within the last month prior to Cycle 1 Day 1 (6 weeks for nitrosoureas, mitomycin-C, and liposomal doxorubicin) other chemotherapeutic, hormonal, or investigational anti-cancer agents with the exception of gonadal suppression agents and bisphosphonates for osteoporosis and skeletal metastases which may be continued while on study
Patient received radiation therapy or major surgery within one month of Cycle 1 Day 1
No recent history (=< 90 days) of substance abuse (outside of tobacco) defined by National Institute on Alcohol Abuse and Alcoholism (NIAAA) as:\r\n* If male, drinking > 14 alcoholic beverages per week for past 1 month\r\n* If female, drinking > 7 alcoholic beverages per week for past 1 month\r\n* Use of cocaine, heroin, club drugs (i.e., 3,4-methylenedioxymethamphetamine (MDMA)/“ecstasy”), methamphetamine, or hallucinogens (e.g., lysergic acid diethylamide [LSD]) at any time during the past 1 month\r\n* Use of marijuana on a weekly basis for the past 1 month
The adjuvant endocrine therapy must have stopped within 1 month prior to enrollment
Completed active treatment (surgery, chemotherapy, and/or radiotherapy) at least one month prior to study initiation (patients on continued hormone treatment will not be excluded)
Within one month (+/- 1 month) of starting chemotherapy or within two weeks (+/- 2 weeks) of starting radiation therapy (may be prior to or after starting treatment)
Have outpatient visits at least once a month
Use of an investigational drug within 1 month prior to dosing
Major surgery/surgical therapy for any cause within 1 month prior to pasireotide administration; patients should have recovered and have a good clinical condition before entering the study
A history of at least moderate CRF over the past month as defined by a CRF score of 4 or more on a 0-10 numerical rating scale
Not currently regularly practicing yoga (defined as at least once a month)
PATIENT ONLY: Patients must be within 1 month of initiating or having undergone any type of cancer treatment (i.e., surgery, radiotherapy, chemotherapy)
Chronic treatment with any inhaled steroid for > 1 month in past three months
Treatment with montelukast or zafirukast for > 1 month in past three months
Treatment with systemic steroids for > 1 month in past three months
Have a diagnosis of incurable cancer of any type; at any time in the diagnosis as long as they have at least a 4 month life expectancy based on the opinion of the attending physician
Female breast cancer survivor who is over 1 month and less than 24 months beyond the completion of primary therapy (surgery, radiation, and chemotherapy).
Participants must be willing and able to travel to CUMC for data collection and optional blood draws at two baseline visits, 6-month and 12-month visit; if needed and depending on staff availability, optional blood draws can be completed at a participant’s home by a certified phlebotomist from our research team
Acute coronary event within the past month
Chronic glucocorticoid or acute glucocorticoid or other synthetic steroid intake within the last month
Surgery or hospitalization within the last month
Surgical treatment in the previous month
Has developed chest pain in the past month
ALS PATIENTS: Already on a stable dose of riluzole for at least one month
ALS PATIENTS: Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) with < or equal to 2 point decline in last month
1 month – 5 years following completion of cytotoxic chemotherapy treatment for any cancer, and are experiencing neuropathy
Presence or recent history of other concurrent cancers, with the following exceptions: \r\n* Participants with completely treated basal or squamous skin cancers can be included in the study if their physicians deem that they are medically stable\r\n* Participants with completely treated in situ carcinoma of the breast or cervix may be included in the study if they have not had chemotherapy within the past month and their physicians deem that they are medically stable\r\n* Participants with pre-cancerous lesions in the colon can be included in the study if they have not had chemotherapy within the past month and their physicians deem that they are medically stable
Pain or symptoms of neuropathy or pain of >= 1 month (30 days) duration for which the patient wants intervention
Severe anemia (hemoglobin [Hb] < 7g/L) if documented in the last month and not corrected prior to study enrollment
Patients must be willing to adhere to the PNP intervention and the entire 6-month study
Minimal expected survival time of one month
Patients who have lost >= 5% of their usual body weight over the preceding 1 month
Use of growth hormone, megestrol, Marinol, or any other anabolic agents, appetite stimulants (including corticosteroids other than dexamethasone at the time of IV chemotherapy administrations), tube feeding, or parenteral nutrition during the 1 month prior to entering the study
History of hemoptysis (>= 1/2 teaspoon of bright red blood per episode) within 1 month prior to day 1
Intractable seizures while on adequate anticonvulsant therapy—more than 1 seizure per month for the past 2 months
Have pain and or changes in sensation in their feet and/or hands of at least one month duration
Received filgrastim (GCSF) treatment within one month of enrollment
Agree to receive text messages on their smartphone over a 3-month period
Oncologists who treat at least 2 advanced cancer patients per month at a study participating hospital
Patients who are currently part of or have participated in any clinical investigation with an investigational drug within 1 month prior to dosing
Patient has a family caregiver who lives with him/her or has visited him/her in-person at least twice a week for the past month
Caregiver lives with the patient or has visited the patient in-person at least twice a week for the past month
Severe anemia (hemoglobin [Hb] < 7 g/L) if documented in the last month and not corrected prior to study enrollment; extra blood work will not be drawn unless the patient already has the lab abnormalities documented and need to be corrected
Bilirubin > 5 x upper limit of normal if documented in the last month and not lowered to < 5 x normal prior to study enrollment; extra blood work will not be drawn unless the patient already has the lab abnormalities documented and need to be corrected
Life expectancy < 1 month or current hospice care
Cancer patients currently receiving chemotherapy (started within the past month) and/or radiation therapy (started within the past week), or
No planned surgery anticipated in the 3-month intervention period
At least 1 month from any major surgery to start of intervention, including colostomy reversal (Port-A-Cath removal excluded)
meet diagnostic criteria for chronic insomnia (i.e., lasting for at least one month)
Patients must readily be available for a 3 month period and agree to participate in regular dietary adherence assessments (surveys and phone interviews)
stroke (within the last 6 month)
Other (non-cancer) disease not stabilized within 1 month before the Screening Visit
Narcotics, antidepressants or other medications for the treatment of CIPN are permitted, if patient on a stable dose for at least one month prior to enrollment
Currently underactive (< 60 minutes of moderate intensity exercise per week in the last month) (confirmed by self-report on the Health History Questionnaire)
Recent steroid treatment within the last month
Presence of hot flashes for >=1 month prior to study entry
Patients >= 65 years with known underlying renal insufficiency get GFR tested within 1 month of the exam.
Patients < 65 years with known renal insufficiency get GFR tested within 1 month of the exam.
Patient is willing to delay prostate biopsy for a 3-month finasteride treatment
Patient is willing to take finasteride 5 mg orally daily for 3-month treatment period
Patient must be above the age of 1 month as of the start date of study treatment.
Reports conducting at least 20 new initial screenings per month
Smokers who are receiving other tobacco treatment services or have used cessation medications (NRT, bupropion, varenicline) within the past month
Use of ASA or NSAIDs for more than 5 days per month within 3 months of enrollment
For women of childbearing potential; negative pregnancy testing within 72 hours prior to or on study visit #1 (day 0) and willingness to use adequate contraception during the study intervention; OR post-menopausal defined as any one of the following 1) prior hysterectomy, 2) absence of menstrual period for 1 year in the absence of prior chemotherapy or 3) absence of menstrual period for 2 years in women with a prior history of chemotherapy exposure who were pre-menopausal prior to chemotherapy; in women of childbearing potential, effective contraception must be used for one month prior to the initiation of therapy, during therapy, and for at least one month following discontinuation of therapy; it is recommended that two reliable forms of contraception be used simultaneously; If participants are interested in enrolling and have not met the requirement for contraception, they will be seen in the clinic in 1 month for re-evaluation once they have met this requirement and ensure all other eligibility criteria is met prior to dose assignment
Prior use of topical or systemic therapies that might interfere with the evaluation of the study medication during the study, within a 3 month washout period from the time of the screening visit
No quit attempts or attempts to cut back in the last month (30 days)
Binge alcohol drinking (4/5 [female/male] drinks per day more than 9 days in the past month)
Daily smoker for ? 6 months, smoking approximately ? 5 cigarettes per day on average in the past month or must meet the criteria for nicotine dependence
Willingness to comply with study procedures:\r\n* Willing to have a blood draw for serum to archive bioavailable estradiol, sex hormone-binding globulin (SHBG), FSH, and bazedoxifene levels as well as a chemistry profile to ensure reasonable normal organ function at baseline and 6 month visits (approximately four tubes of blood collected)\r\n* Willing to have a DEXA scan for body composition and waist measurement at baseline and 6-8 months\r\n* Willing to have a repeat mammogram and RPFNA at 6-8 months following initiation of study drug\r\n* Willing to undergo a history, physical, vitals and breast exam at baseline and 6 month visits\r\n* Willing to be contacted by the trial coordinator at months 1 and 3 during the 6 month study period\r\n* Willing to complete a 29 item validated menopause quality of life intervention questionnaire and hot flash assessment at baseline and 6 month visits\r\n* Willing to sign and able to understand separate consents for the RPFNAs and for study participation
Engaging in three or more intercourse events (defined as having penile-vaginal intercourse) per month; subjects must consent not to douche or use any vaginal products, including tampons, for 24 hours before enrollment and study visits
A cardiovascular event in the past month
Use of pharmacotherapy in the month prior to enrollment, including prior use of varenicline
Active use or recent use (=< to 1 month) of medication or e-cigarettes for nicotine dependence/smoking cessation, or use of e-cigarettes for more than 9 days in the prior month
Unwillingness to prevent pregnancy during the medication phase and 1 month afterwards (women only)
Have been non-daily smokers for at least the previous year (< or = 27 days/month);
All participants must also report an intention to quit smoking within the next month and a desire to receive behavioral and medication treatment.
Participation in a study which involved medication within the last month
Low grade NHL – with < 6 month duration of CR between courses of conventional therapy
Patients with fungal pneumonia with radiological progression after receipt of amphotericin formulation or mold-active azoles for greater than 1 month
Provided a secondary phone or email contact to ensure one month follow-up survey completion
Suffering from a terminal illness with less than 12 month life expectancy
Terminal illness with less than 12 month life expectancy
Willing to undergo a history and physical at baseline and 12 months and be contacted periodically by the trial coordinator during the 12 month study period
No chronic use of aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) or selective cyclooxygenase-2 (COX-2) inhibitors during one month prior to randomization; chronic use is defined as any aspirin or NSAID use on >= 7 days during one month preceding the beginning of randomization
STUDY I: >= 1 month of e-cigarette use
STUDY II: Using e-cigarettes at least once per week over the past month
FOLLOW-UP ASSESSMENTS: Be 50 years of age or older by the time of the 3-month telephone follow-up assessment
Subjects must be on therapy with bisphosphonates or denosumab for at least 1 month before start of study treatment.
Patients who are currently part of or have participated in any clinical investigation with an investigational drug within 1 month prior to dosing
Patients should have been off other investigational therapy for one month prior to entry in this study
Daily DHA consumption =< 200 mg/day in the month prior to screening estimated by an abbreviated DHA food frequency questionnaire
History of DHA supplementation > 200 mg/day in the month preceding study entry
If undergoing adjuvant therapy (e.g. tamoxifen or aromatase inhibitors) willing and able to remain on current regimen for entire 6-month study period
Participants of child-bearing age must use appropriate contraception (barrier, hormonal or post-menopausal) until one month after study medication ends
Use of ASA or NSAIDs for more than 5 days per month within 3 months of enrollment
Taking Bean-O, other anti-flatulence medications or prolonged antibiotic use (one month)
Use of pharmacotherapy in the month prior to enrollment, including prior use of varenicline
Female planning to become pregnant or planning to discontinue contraceptive precautions before Month 3 (i.e., 2 months after the last dose of study vaccine/placebo).
Subjects taking calcium supplements; if subjects are willing to discontinue these supplements, there must be a 2-month wash out period before enrollment
Renal insufficiency with recent (< 3 month old) creatinine > 2.0
A patient who has not received systemic or loco-regional treatment of the tumor within the last month.
Intravenous (IV) contrast exposure in the past 1 month
Renal insufficiency with recent (< 3 month old) creatinine > 2.0 mg/dL
Less than 1 month since any prior prostate biopsy (to decrease false positive from inflammation)
HEALTHY VOLUNTEER: Exposure to ultrasound contrast agents (UCAs) in the 1 month prior to study initiation
Scheduled for surgery and/or another invasive procedure (except biopsy) within the time period of 1 month prior to 18F FSPG administration
Current or prior androgen deprivation therapy; a history of use of a 5-alpha reductase inhibitor is allowed, provided it was discontinued at least one month prior to study entry
The patient must agree at the time of study entry to undergo clinically indicated biopsy(ies) or 24-month period of follow-up, as needed, to resolve the etiology of their IPN(s) or lung mass(es)
Women who will receive or have already received a breast MRI within one month of the CESM
Have undergone chemotherapy or radiation therapy within the previous one month
Patients who have had surgery at the site of the suspected lesion within 1 month
Diabetic patients with a blood creatinine level > 1.5 mg/dl within a month of this procedure
Participants unwilling to complete the protocol (24 month duration)
Use of antibiotics one (1) month prior to or during this study
Participation in another clinical study in the month preceding this study
Have undergone chemotherapy or radiation therapy within the previous one month
Patients who have had surgery at the site of the suspected lesion within 1 month
Less than 1 month since any prior prostate biopsy (to decrease false positive uptake from inflammation)
Documented surgically sterile or status posthysterectomy (at least 1 month prior to screening)
Core biopsies obtained within 1-month of MRI/MRE
Willing to use contraception during and for 1 month after completion of the study
The subject has received, or is scheduled to receive, another IMP from 1 month before to 1 month after inclusion in this study
Current or prior androgen deprivation therapy; previous use of a 5-alpha reductase inhibitor is allowed, provided it was discontinued at least one month prior to study entry
Patient is scheduled for brain surgery and/or another invasive procedure within the time period of one month prior to 18F-FSPG administration. Minimally invasive needle biopsies are allowed.
A history of antibiotic use within one month prior to initial PSA level measurement
Able to deliver four fresh (within 24 hours) stool samples to Mayo Clinic Rochester over a four month period
Current or prior systemic use of corticosteroids in the past month
Recipient of vaccines within 1 month of or during study drug treatment.
AIM 2: Text messaging more than once a month
Receiving treatment for advanced lung cancer for over one month before enrollment; OR
TIPs INCLUSION: Planning on remaining in NYC for at least 1 year, (with no vacations or trips to exceed one month)
past six month use of any e-cigarette
Inclusion criteria:\n\n 1)15-29 year olds receiving treatment for any type of cancer, either primary or\n recurrent/relapsed disease.\n\n 2) Patient has completed at least one month of therapy\n\n 3)Patient is expected to remain on therapy for 3 month duration of study\n\n 4) Patient has an iPhone, iPad, or iTouch running iOS 4.0 or later\n\n 5) Patient is willing to use a smart-phone medication reminder application-\n\n Exclusion Criteria:\n\n 1)Patients who are unable to speak/read/write English as required for use of smart-phone\n medication reminder application and completion of study measures.
Inclusion criteria:\n\n 1)15-29 year olds receiving treatment for any type of cancer, either primary or\n recurrent/relapsed disease.\n\n 2) Patient has completed at least one month of therapy\n\n 3)Patient is expected to remain on therapy for 3 month duration of study\n\n 4) Patient has an iPhone, iPad, or iTouch running iOS 4.0 or later\n\n 5) Patient is willing to use a smart-phone medication reminder application-\n\n Exclusion Criteria:\n\n 1)Patients who are unable to speak/read/write English as required for use of smart-phone\n medication reminder application and completion of study measures.