data stringlengths 112 4.42k | criteria stringlengths 19 13.2k |
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Study Objectives
The purpose of the study is to evaluate the effectiveness and side effects of the drugs capecitabine and docetaxel in the treatment of cervical cancer. Capecitabine is approved by the FDA for the treatment of breast and colon cancer. Docetaxel is approved in the treatment of breast and lung cancer. The... | Inclusion Criteria:
* Patients must have histologically proven stage IVB, recurrent or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy
* Age greater than or equal to 18
* All patients must hav... |
Study Objectives
This project is a multicenter study in which we will investigate a dual concept of nevogenesis. Study location is the Department of Dermatology at the Medical University of Graz in collaboration with centers in Austria (Vienna), Italy (Naples, Benevento, Modena), Spain (Barcelona) and the United States... | Inclusion Criteria:
* Healthy individuals aged 9 to 80 years showing one or more dermoscopically benign nevi with either uniform globular-cobblestone pattern or reticular pattern or a combination of both types
Exclusion Criteria:
* Children under the age of 9 years
* Pregnant woman
* Patients with atypical nevi (i.e... |
Study Objectives
The purpose of this study is to determine whether the administration of the PhytoMed™ complement reduces CRP in women with histologically confirmed AJCC Stage 0-IIIA breast cancer which has been completely surgically resected and without evidence of disease as determined by their physician
Interventio... | Inclusion Criteria:
* Women with histologically confirmed AJCC Stage 0-IIIA breast cancer which has been completely surgically resected.
* No evidence of disease as determined by their physician.
* ER+ and/or PR+ tumour.
* Receiving an aromatase inhibitor (letrozole, anastrazole, exemestane) or tamoxifen at a stable d... |
Study Objectives
Cancer screening can improve the length and quality of life, yet the average American receives only half of recommended services. Patient-centered personal health records with higher levels of functionality, combined with practice redesign to make use of these functions, can help patients obtain recomm... | Inclusion Criteria:
* Practices in a practice based research network participating in our study that have an existing patient health record
* Patients that attend our study practices
Exclusion Criteria:
Practices without a patient health record |
Study Objectives
Title: IDO peptid vaccination in combination with immune stimulating agent Aldara and the adjuvant Montanide, for treatment of patients with locally advanced or metastatic non small-cell lung cancer. A first-in-man phase I trial.
Hypothesis: In this trial the investigators assess a new immunotherapeut... | Inclusion Criteria:
* Histological or cytological verified non small cell lung cancer * Metastatic or locally advanced incurable stage III-IV NSCLC * Patients need to be off chemotherapy treatment * Evaluable disease according to RECIST V. 1,1 criteria * Patients must be HLA-A2 positive * Patients > 18 years old * Per... |
Study Objectives
Rationale: For resectable esophageal cancer the standard therapy is 5 weeks of neoadjuvant chemoradiotherapy (nCRT) followed by surgery 6-8 weeks afterwards. Surgery is performed independent of the response to nCRT and is associated with substantial morbidity. A pathological complete response (pCR) aft... | Inclusion Criteria:
* Histologically confirmed squamous-cell carcinoma, adenocarcinoma or large-cell undifferentiated carcinoma of the esophagus or esophagogastric junction (i.e. tumors involving both cardia and esophagus on endoscopy)
* Potentially resectable tumor (cT1b-4a N0-3 M0): based on standard primary staging... |
Study Objectives
This study is a Phase III, randomised, open label, multi-centre study assessing the efficacy and safety of MEDI4736 (durvalumab) versus Standard of Care in NSCLC patients with PD-L1 positive tumours and the combination of MEDI4736 (durvalumab) plus tremelimumab (MEDI4736+treme) versus Standard of Care ... | Inclusion Criteria:
* Aged at least 18 years
* Documented evidence of NSCLC (Stage IIIB/ IV disease)
* Disease progression or recurrence after both a platinum-based chemotherapy regimen and at least 1 additional regimen for treatment of NSCLC
* World Health Organization (WHO) Performance Status of 0 or 1
* Estimated l... |
Study Objectives
This study evaluates the effect of intermittent calorie restriction versus continued calorie restriction on weight loss, gene expression profile of subcutaneous adipose tissue and abdominal fat distribution.
Intervention / Treatment
OTHER: Calorie Restriction
| Inclusion Criteria:
* Women and men aged 35 to 65 years
* Overweight or obese (BMI ≥ 25 kg/m2 ≤ 40 kg/m2 )
* German speaking
* Non- smoker
* Provision of written informed consent
Exclusion Criteria:
* Not able to understand and sign the informed consent form in person
* Already diagnosed diabetes
* HbA1c ≥ *5 % and/... |
Study Objectives
Rationale: Like in primary breast cancer, prognosis in recurrent breast cancer is correlated with regional lymph node status. Therefore, axillary staging may be warranted in patients with recurrent disease and intact axillary nodes, although this has not been described in guidelines yet. The lymphatic ... | Inclusion Criteria:
* treatment with BCT with SNB and/or ALND for primary breast cancer
* previous primary breast cancer located in the upper-outer quadrant of one breast
* Primary breast cancer treatment at least 3 years before the analysis, with or without adjuvant chemo- or hormonal therapy.
Exclusion Criteria:
*... |
Study Objectives
Study to assess the safety and tolerability of repeated doses of an investigational new drug in patients with cancer and cachexia.
Intervention / Treatment
DRUG: PF-06946860
| Inclusion Criteria:
* Documented histologic or cytologic diagnosis of advanced metastatic NSCLC, advanced/unresectable pancreatic cancer, or metastatic colorectal cancer.
* Cachexia, defined by BMI <20 kg/m2 with involuntary weight loss of >2% within 6 months prior to screening or Involuntary weight loss of >5% within... |
Study Objectives
To determine whether simvastatin at a dose of 80mg can reduce the rate of whole brain atrophy, as measured by MRI, over a 2-year time-period when compared to placebo.
Intervention / Treatment
DRUG: Simvastatin, DRUG: Placebo
| Inclusion Criteria:
* Patients must have a confirmed diagnosis of multiple sclerosis and at randomisation have entered the secondary progressive stage. Steady progression rather than relapse must be the major cause of increasing disability in the preceding 2 years. Progression can be evident from either an increase of... |
Study Objectives
The present study is a prospective cohort study. The aim is to assess the relationship between the presence of cancer stem-cells (CSC) and the risk of relapse in patients with early and locally advanced adenocarcinoma and squamous cell carcinoma of the lung
Intervention / Treatment
GENETIC: Exposure t... | Inclusion Criteria:
* patients with stage I, II or IIIA adenocarcinoma of squamous cell carcinoma of the lung
* age between 18 and 85
* R0 resection
* availability of formalin-fixed, paraffin-embedded surgery specimen from the primary tumor
* availability of fresh surgical specimen for cytofluorimetric analysis
Exclu... |
Study Objectives
This study will assess the toxicity/safety of CHOP chemotherapy given concurrently with rituximab, followed by maintenance PEG Intron in patients with anthracycline naïve indolent non-Hodgkin's lymphoma. This study will also evaluate response rates, time to progression, molecular response, and immunolo... | Inclusion Criteria:
* Patients with a diagnosis of advanced stage indolent non-Hodgkin's lymphoma expressing the CD20 surface antigen (as measured by immunohistochemistry or flow cytometry on peripheral blood, marrow, or tumor tissue). Specific histologic subtypes which are eligible include follicular small cleaved ce... |
Study Objectives
This prospective, observational study is to assess the long-term effectiveness and safety of Atezolizumab in patients with advanced non-small cell lung cancer in clinical practice.
Intervention / Treatment
| Inclusion Criteria:
* Patients 20 years of age or older at the time of signed consent.
* Patients with locally advanced or metastatic non-small cell lung cancer.
* Patients who are scheduled to start Atezolizumab monotherapy, based on the Atezolizumab package insert and the Optimal Use Promotion Guideline.
* Patients ... |
Study Objectives
Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from microbes that degrade arginine. ADI has been formulated with polyethylene glycol and has been used to treat patients that have cancers that require arginine. In this study, the investigators will evaluate the re... | Inclusion Criteria:
* Diagnosis of HCC confirmed clinically or histologically or cytologically. A clinical diagnosis of HCC, using the 2010 Guideline of the American Association for the Study of Liver Diseases requires the presence of hepatic tumor(s) with image findings (e.g. sonography, CT or MRI) compatible with HC... |
Study Objectives
The purpose of this research study is to determine the safety of the study drug pemetrexed, and the highest dose of this drug that can be given to people safely. Another goal of this research study is to gain information about how the body handles pemetrexed and how pemetrexed may work to treat the par... | Inclusion Criteria:
* Disease state (5 categories of patients with these extremely rare disease are eligible: 1) Patients intolerant of Methotrexate-must have a diagnosis of B cell non-Hodgkin's lymphoma 2) Patients unable to receive methotrexate due to lack of drug availability-must have a diagnosis of B cell non-Hod... |
Study Objectives
The objective of this study is to evaluate the clinical utility, safety and effectiveness of the Manual Mini System compared to standardized warm compress therapy for application of controlled, localized heat therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian g... | Inclusion Criteria:
* At least 18 years of age.
* Meibomian gland obstruction
* Dry eye symptoms
* Willingness to comply with study procedures and return for all visits
Exclusion Criteria:
* Ocular surgery, injury, or herpes infection within past 3 months
* Active ocular infection
* Active ocular inflammation or rec... |
Study Objectives
This pilot clinical trial studies stereotactic body radiation therapy in treating patients with metastatic kidney cancer undergoing surgery. Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
Intervention / Treatment
RADIATION: stere... | Inclusion Criteria:
* Have metastatic RCC with primary tumor in place
* Must be surgical candidates as deemed fit by surgeon
* Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) *1 criteria present
* Patients of child-bearing potential must agree to use adequate contraceptive methods (e.... |
Study Objectives
This study will evaluate the efficacy of crizotinib as induction therapy in participants with surgically resectable ALK rearrangement, ROS1 rearrangement, or MET exon 14 mutation positive NSCLC.
Intervention / Treatment
DRUG: Crizotinib
| Inclusion Criteria:
* Stage IA-IIIA NSCLC by 8th edition AJCC staging (that is deemed to be surgically resectable by a board certified thoracic surgeon.
* Staging by PET-CT scan and MRI brain showing no evidence of metastatic disease (mediastinoscopy is not required unless imaging is indeterminate and is then consider... |
Study Objectives
In Patients with metastatic colorectal cancer the following treatments first-line Folfiri+Cetuximab first-line Folfox6 + Cetuximab will be concerning efficacy and safety.
The trial compares Folfiri + Cetuximab and Folfox6 + Cetuximab concerning efficacy and safety as first
Intervention / Treatment
DR... | Inclusion Criteria:
* Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum
* Metastatic colorectal carcinoma not suitable for curative-intent resection
* Availability of tumor sample (or able and willing to provide tumor sample) for EGFR assessment
* Presence of at least one lesion measurable un... |
Study Objectives
This phase II trial studies how well metformin hydrochloride, leucovorin calcium, fluorouracil, and oxaliplatin work in treating patients with metastatic pancreatic cancer. Metformin hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in c... | Inclusion Criteria:
* Patients must have histologically or cytologically confirmed metastatic pancreatic adenocarcinoma (or any mixed pathology if adenocarcinoma is predominant)
* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest di... |
Study Objectives
The purpose of this study is to investigate whether F-18 FLT PET/CT is useful in early response assessment of induction chemotherapy in acute myeloid leukemia patients.
Intervention / Treatment
OTHER: FLT PET/CT
| Inclusion Criteria:
* acute myeloid leukemia
* must receive induction chemotherapy
* 19 years old and over
Exclusion Criteria:
* no standard therapy
* pregnancy |
Study Objectives
This is an open-label, dose escalation, Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy of IBI939 in subjects with advanced malignancies
Intervention / Treatment
DRUG: IBI939, DRUG: IBI939+ Sintilimab, DRUG: IBI939+ Sintilimab
| Inclusion Criteria:
* Able to understand and willing to sign the ICF.
* Adults 18 years of age or older.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or *
* Life expectancy at least 12 weeks.
* Adequate organ and bone marrow function.
Eligibility Criteria：
* Previous exposure to any anti-TIGIT... |
Study Objectives
This study investigates if an experimental blood test can help predict how well cancer will remain under control with treatment. Ther experimental blood test involves measuring mircoRNAs. MicroRNAs are small molecules which help regulate how genes are expressed. This information may help researchers gu... | Inclusion Criteria:
* Provide signed and dated informed consent form
* Willing to comply with all study procedures and be available for the duration of the study
* Definite diagnosis of hepatocellular carcinoma established (by standard radiographic or histologic criteria)
* Felt to be reasonable candidate for liver tr... |
Study Objectives
A recent prospective multicenter study by Dr. Grossman demonstrated that 40% of patients with high grade glioma undergoing radiation and chemotherapy developed severe and persistent lymphopenia (CD4 counts \<200 cells/mm3). This lymphopenia lasted for twelve months following radiation treatment and on ... | Inclusion Criteria:
* Gender: Male and Female
* Age: Patients must be at least 18 years of age.
* Race: Minorities will be recruited. No exclusion to this study will be based on race.
* Patients must have histologically confirmed high grade astrocytoma, WHO grade III or IV, by pathology.
* Patients' proposed post-oper... |
Study Objectives
The overall goal of the COACH study is to conduct a comparative effectiveness trial to assess the effectiveness of trained, participant-designated health coaches versus traditional health education efforts on cancer screening among African American older adults. We hypothesize that members of older adu... | Inclusion Criteria:
* Resident in Baltimore City, MD or Prince George's County, MD
* African American
* 50-74 years of age
* Eligible for breast, cervical and/or colorectal cancer screenings at time of study enrollment
* Has a support person who is willing to participate in the study
Exclusion Criteria:
* Diagnosis ... |
Study Objectives
To confirm the feasibility of studying Xtampza ER during radiotherapy (RT) for LAHNC as part of a prospective clinical trial.
Intervention / Treatment
DRUG: Xtampza ER
| Inclusion Criteria:
* Histologically confirmed locally advanced cancer of mucosa of the head and neck.
* Eligible subsites will include nasal cavity, paranasal sinuses, nasopharynx, oropharynx, oral cavity, major salivary glands, oropharynx, larynx, hypopharynx, cervical esophagus, or unknown primary site with lymph n... |
Study Objectives
This is a single-institution pilot study seeking preliminary evidence of the usefulness of mobile gamma cameras in patients undergoing sentinel node biopsy for melanoma.
Intervention / Treatment
| Inclusion Criteria:
* 18 years of age or older, AND
* plan to go to the operating room for sentinel node biopsy using technicium-99 labeled colloid.
Exclusion Criteria:
* under 18 years of age,
* unable to give informed consent, OR
* not planned to go to operating room for sentinel node biopsy using technicium-99 la... |
Study Objectives
This study will determine the maximum tolerated dose (MTD) and/or the recommended phase II dose (RP2D) of single agent ONC201 in patients with advanced solid tumors or multiple myeloma.
Intervention / Treatment
DRUG: ONC-201
| Inclusion Criteria:
* Solid tumor specific:
* Patients must have a histologically/cytologically confirmed primary solid tumor
* Radiographic or clinical evidence of advanced/metastatic malignant disease that is resistant to standard therapy or for which no standard therapy is available. Lesions may be measurabl... |
Study Objectives
The primary objective of this study is to assess the safety and efficacy of ABT-510 in subjects with advanced renal cell carcinoma.
Intervention / Treatment
DRUG: ABT-510/Thrombospondin-1 mimetic
| Inclusion Criteria:
A subject will be eligible for study participation if all of the following criteria are met:
* The subject is at least 18 years of age.
* The subject has advanced histologically documented renal cell carcinoma. Advanced disease is defined as locally recurrent disease or metastatic disease that is ... |
Study Objectives
This trial studies how well progressive resistance training works in improving the physical function of sarcoma survivors. Treatments for sarcoma can cause side effects such as fatigue, muscle loss, and weakness, which can negatively impact a patient's ability to physically function and enjoy an indepe... | Inclusion Criteria:
* Eligible for the Sarcoma Survivorship Registry (Institutional Review Board \[IRB\] #12039)
* History of histologically-confirmed sarcoma
* History of treatment with surgery, radiation and/or chemotherapy for the sarcoma diagnosis
* Completion of sarcoma treatment >= 2 years prior to study ... |
Study Objectives
The purpose of this study is to:
1. Evaluate how the body reacts to sorafenib when taken daily in combination with paclitaxel and carboplatin,
2. Measure the blood levels of sorafenib, paclitaxel and carboplatin at specific times after taking the medication, and
3. To determine the safety of sorafenib... | Inclusion Criteria:
* Age > or equal to 18 years
* Histological or cytological documentation of cancer, except non small cell lung cancer
* ECOG Performance Status of 0 or 1
* Life expectancy of at least 12 weeks
* No more than two prior chemotherapy regimens
* Adequate bone marrow, liver and renal function as assesse... |
Study Objectives
Eligible candidates will be adults with metastatic pancreatic cancer (confirmed diagnosis with pathology reports and measurable computed tomography (CT) or magnetic resonance imaging (MRI)). Participants must not be receiving any other concurrent chemotherapy, or radiation therapy. Full inclusion/exclu... | Inclusion Criteria:
* Metastatic pancreatic cancer
* Glucose 6 phosphate dehydrogenase status normal
* ECOG performance status 0-2
* Normal creatinine and transaminase
* Women of child-bearing potential confirm negative pregnancy test
Exclusion Criteria:
* Concurrent chemotherapy or radiotherapy
* Significant co-mor... |
Study Objectives
The purpose of this study is to determine whether rapamycin is safe and effective in the treatment of renal angiomyolipomas in patients with tuberousclerosis.
Intervention / Treatment
DRUG: Sirolimus
| Inclusion Criteria:
Diagnosis of tuberousclerosis Angiomyolipoma >2cm age>10 years
Exclusion Criteria:
Creatinine >4 No recent AML bleeding No hepatic abnormalities (liver tests 2fold) Hematocrit<27% Thrombocytopenia (<*000/mm3) Leukopenia (<3000/mm3) Ischemic cardiopathy Recent surgery (2 months prior to enrollment... |
Study Objectives
The purpose of this study is to determine the safety profile, pharmacokinetics, pharmacodynamics and maximum tolerated dose of RAF265 in patients with locally advanced and metastatic melanoma.
Phase II portion of study (dose expansion) has been cancelled with Amendment 7 as of Dec 2011.
Intervention ... | Inclusion Criteria:
* Confirmed diagnosis of melanoma, locally advanced AJCC Stage IIIB to metastatic Stage IV
* Measurable disease - at least one lesion measured in at least one dimension as ≥ 20 mm with conventional techniques or ≥ 10 mm with spiral computed tomography (CT) scan
* ECOG performance status of 0 or 1
*... |
Study Objectives
This study aims to compare the efficacy and participant experience of telehealth-based, self-collected cervical cancer screening to mail-based, self-collected cervical cancer screening across the adult female screening lifespan. This will be done by evaluating sufficient Human papillomavirus (HPV) samp... | Inclusion Criteria:
* Individuals with a cervix who are eligible for primary HPV testing (age 25 and older) according to national cervical cancer screening guidelines.
* Pregnant women are eligible for participation in this study as the collection process poses no threat to the woman or her fetus.
Exclusion Criteria:... |
Study Objectives
Claudiximab is a monoclonal antibody specific for gastric and gastroesophageal adenocarcinomas. Preclinically, claudiximab was shown to inhibit tumor growth and to kill cancer cells by indirect (complement-dependent cytoxicity, antibody-dependent cellular cytotoxicity) and direct mechanisms (antiprolif... | Inclusion Criteria:
* Metastatic, refractory or recurrent disease of advanced gastroesophageal cancer (adenocarcinoma) proven by histology
* CLDN*2 expression confirmed by immunohistochemistry
* Prior standard chemotherapy containing a fluoropyrimidine, a platinum compound and/or epirubicine, and - if clinically appro... |
Study Objectives
A centralized web-based database will be used to track patients with IPMN lesions of the pancreas to study natural history and risk factors for malignant transformation in this multi-center study.
Intervention / Treatment
| Inclusion Criteria:
* Suspected IPMN based on the consensus guidelines *
* Endoscopic ultrasound imaging at baseline examination
* Either surgical histology or clinical follow up with EUS, MRI, or CT scan for at least 1 year
* Cases previously collected that meet the above criteria will be allowed
Exclusion Criteria:... |
Study Objectives
This clinical trial studies a palliative care intervention in improving symptom control and quality of life in patients with stage II-IV non-small cell lung cancer and their family caregivers. Palliative care programs can provide patients and their caregivers with information on how to manage their sym... | Inclusion Criteria:
Patient eligibility criteria for entry into the project include:
* Diagnosis of stages II-IV non-small cell lung cancer (NSCLC)
* Undergoing treatment with surgery, chemotherapy, radiation, or combined modalities
* In Phase 2, subjects are also required on accrual to be referred to Palliative Care... |
Study Objectives
This clinical trial seeks to determine if avelumab will be effective in facilitating removal of all gross tumor in the event of a relapse of osteosarcoma in pediatric patients. Avelumab will be evaluated using dosing that has previously been determined in adult studies.
Primary Objectives:
* To estim... | Inclusion Criteria:
* Patients must be > 12 years of age but < 50 years of age at the time of enrollment.
* Patients must have histologic verification of osteosarcoma at initial diagnosis or relapse.
* Patients must have had evidence of having relapsed, progressed or become refractory to conventional therapy.
* Patien... |
Study Objectives
There is a new form of cancer treatment called immunotherapy which does not attack cancer directly but works on the immune system to make it more effective. This type of treatment may have side effects which are called autoimmune side effects and are caused by the immune system attacking the normal par... | Inclusion Criteria:
* Be willing and able to provide written informed consent for the trial.
* Be 18 years of age on day of signing informed consent.
* Have a confirmed metastatic melanoma of cutaneous or mucosal origin, and if cutaneous to be confirmed BRaf wild-type.
* Be willing to provide blood samples in line wit... |
Study Objectives
The aim of this study is to assess the performance of the CB-17-08 to help endoscopists find potential mucosal polyps during the colonoscopy procedure, without significant noise disturbing the endoscopist attention, nor negative interference with the lesions detection than with the standard colonoscopy... | Inclusion Criteria:
* Male and female patients age: ≥45 years;
* Patients presenting to the endoscopy unit for a screening colonoscopy or a surveillance colonoscopy for CRC;
* Willingness to undergo tandem colonoscopies with and without the use of CB-17-08 on the same day and in the same procedural setting;
* Ability ... |
Study Objectives
Primary Objective: To evaluate the safety, tolerability and maximum tolerated dose (MTD) of daily oral administration of metatinib tromethamine in subjects with solid tumors; Investigate the influence of food on pharmacokinetic parameters.
Secondary Objective: To evaluate the plasma pharmacokinetics (... | Inclusion Criteria:
* Weight: male weight ≥ 45 kg; female weight ≥ 40 kg, body mass index (BMI) between 18\~24 kg/m\^2, including the boundary values;
* The subject has a histologically confirmed solid tumor that is metastatic or unresectable, and for which standard curative or palliative measures do not exist or are ... |
Study Objectives
This open label phase-II trial evaluates hematological response of an additional treatment with 5-Azacitidine to common DLI in patients with MDS or AML relapsing after allogeneic stem cell transplantation.
Intervention / Treatment
DRUG: 5-Azacitidine
| Inclusion Criteria:
* Primary and secondary MDS, AML after MDS, and de novo AML relapsing after allogeneic stem cell transplantation
* Eligibility for Donor Lymphocyte Infusions
* Performance status according to the WHO scale: 0, 1 or *
* Adequate renal and liver function: bilirubin < *5 times the upper limit of norm... |
Study Objectives
Healing of mucosal defects after endoscopic mucosal resection in the oesophagus is prone to result in varying degrees of stenosis, especially if the resected area is large and/or circumferential. A new technique was described where autologous cells from the patients own oral mucosa are harvested and cu... | Inclusion Criteria:
* Barrets esophagus, histologically confirmed, or early oesophageal cancer (both squamous and adeno)
Exclusion Criteria:
* no consent can be given
* prior ESD/EMR |
Study Objectives
This study will evaluate the efficacy and safety of midostaurin in combination with daunorubicin/cytarabine induction, high dose cytarabine consolidation and midostaurin single agent continuation therapy in newly diagnosed patients with FLT3-mutated acute myeloid leukemia (AML).
Intervention / Treatme... | Inclusion Criteria:
* Diagnosis of AML (≥ 20% blasts in the bone marrow based on WHO 2016 classification). Patients with APL (acute promyelocytic leukemia) with PML-RARA are not eligible
* Documented presence of an ITD and/or TKD activating mutation in the FLT3 gene, as determined by analysis in a Novartis designated ... |
Study Objectives
Neo- and adjuvant chemotherapy is used in high-risk soft tissue sarcoma to improve systemic control. Patients in this trial are treated with 4 cycles of chemotherapy (EIA, etoposide, ifosfamide, adriamycin) preoperatively, followed by local surgery and radiotherapy. An additional 4 cycles of adjuvant c... | Inclusion Criteria:
* Soft tissue sarcoma histology
* Tumor size >= 5 cm
* Deep/extracompartimental localization
* Grade 2/3 (FNCLCC)
* Patients with inadequate previous therapy
* Age 18-65 years
* normal bone marrow function
* normal liver function
* normal renal function
* Karnofsky index >=80%
Exclusion Criteria:
... |
Study Objectives
Patients who meet the enrollment criteria will be randomized 1:1 to either the lidocaine or the placebo group.
In the lidocaine group, at the end of the induction of general anesthesia, a bolus injection of lidocaine 1.5 mg/kg, calculated using the patient's ideal body weight and given as an infusion ... | Inclusion Criteria:
* Age: 18-80 years old
* American Society of Anesthesiologists(ASA) Ⅰ～III
* patients scheduled for elective hepatectomy
Exclusion Criteria:
* body weight < 40 kg or >100 kg; metastases occurring in other distant organs; severe hepatic insufficiency (aspartate aminotransferase or alanine transamin... |
Study Objectives
Haploidentical hematopoietic stem cell transplantation irrespective of the conditioning and graft-versus-host disease prophylaxis is associated with high frequency of primary and secondary graft failure. Different technologies of with replete or depleted graft are associated with 10-20% of graft failur... | Inclusion Criteria:
* Patients must have an indication for allogeneic hematopoietic stem cell transplantation with myeloablative conditioning for malignant disease
* Patients with 5-9/10 HLA-matched related donor available. The donor and recipient must be identical by the following genetic loci: HLA-A, HLA-B, HLA-Cw, ... |
Study Objectives
This is an exploratory prospective observational cohort study to establish the levels of psychological distress in early phase clinical trial patients and evaluate the psychological impact of early phase clinical trials on cancer patients. Participants will be requested to complete self-reported questi... | Inclusion Criteria:
* Aged 18 years and older
* Able to provide informed consent
* Are being considered for an early phase clinical trial
Exclusion Criteria:
* Patients unable to comprehend English language |
Study Objectives
This study is a randomized clinical trial of a psychosocial pain management intervention called, Meaning-Centered Pain Coping Skills Training (MCPC). Patients with advanced solid tumor cancer and at least moderate pain will be randomized to MCPC or a standard care control condition. Patient-reported ou... | Inclusion Criteria:
* Stage IV solid tumor cancer diagnosis; or stage III pancreatic or lung cancer diagnosis
* At least moderate pain (worst pain in past week >/= 4 out of 10) at screening
* Eastern Cooperative Oncology Group (ECOG) performance status </= 2 at screening
* Ability to speak and read English
Exclusion ... |
Study Objectives
This study aims to collect real world outcomes of Video-Assisted Thoracoscopic Surgery (VATS) for lung cancer (lobectomy, wedge resection) using ECHELON FLEX™ Powered ENDOPATH® Staplers 45 mm and/or 60 mm (study devices).
Intervention / Treatment
PROCEDURE: VATS for confirmed non-small cell lung cance... | Inclusion Criteria:
* Histologically confirmed NSCLC (up to and including Stage II) for patients undergoing VATS lobectomy. For patients undergoing wedge resection for undiagnosed pulmonary nodule or metastasis from CRC, a malignant diagnosis may be confirmed post-operatively.
* Scheduled for lung resection surgery (l... |
Study Objectives
The purpose of this study is to be able to supply an experimental combination of drugs called 3F8 and GM-CSF (also called sargramostim) to patients with high-risk neuroblastoma who may benefit from treatment.
Intervention / Treatment
BIOLOGICAL: Anti-GD2 3F8 Monoclonal Antibody, DRUG: GM-CSF (granuloc... | Inclusion Criteria:
* Diagnosis of NB as defined by international criteria,62 i.e., histopathology (confirmed by the MSKCC Department of Pathology) or BM metastases plus high urine catecholamine levels.
* High-risk NB, as defined by risk-related treatment guidelines and the International NB Staging System, i.e., stage... |
Study Objectives
This trial will be conducted to evaluate the efficacy, safety and tolerability of a combination of gemcitabine plus sorafenib in comparison of gemcitabine plus placebo as a first-line palliative therapy in chemo-naive advanced or metastatic CCC. There is strong scientific rationale for exploring the ro... | Inclusion Criteria:
* Male and female patients aged 18 years and older
* Signed and dated informed consent before the start of specific protocol procedures
* Adenocarcinoma of the gallbladder or intrahepatic bile ducts or histologically proven hepatic metastases of an earlier resected and histologically proven biliary... |
Study Objectives
Study to assess the safety and tolerability of three doses of PBF-509 (80 mg, 160 mg and 240 mg) after repeated (8 days) single daily oral dose administration in young male and female healthy subjects.
Intervention / Treatment
DRUG: PBF-509, DRUG: Placebo
| Inclusion Criteria:
* Healthy male or females subjects, 18-45 years (inclusive) of age at the time of enrollment.
* Females must be of non-childbearing potential (i.e., surgically sterile) or have to use contraceptive measures (non-hormonal) such as condom, diaphragm or cervical/vault cap with spermicide. Males should... |
Study Objectives
Use of ethanol injection in treatment of cystic thyroid nodule
Intervention / Treatment
DRUG: ethanol injection
| Inclusion Criteria:
* Adult male or female patient with cystic thyroid nodule
* Presence of pressure symptoms or cosmetic problems
* Benign lesions confirmed by histopathological examination by FNAC.
* Serum levels of thyroid hormone thyrotropin, within normal limits.
Exclusion Criteria:
* Nodules showing malignant ... |
Study Objectives
A clinically applicably strategy for molecular screening for Lynch Syndrome has been implemented in the Region of Southern Denmark.
Based on sequential analysis with immunohistochemistry and methylation analysis, patients with possible hereditary colorectal cancer are identified. These patients are of... | Inclusion Criteria:
* Histological diagnosis of colorectal adenocarcinoma
* Diagnosed at one of the five departments of pathology in the region
Exclusion Criteria:
* None |
Study Objectives
The primary objective of the study is to determine the maximum tolerated dose (MTD) based on the incidence of dose limiting toxicity (DLT) and the maximum administered dose (MAD) of ombrabulin combined with paclitaxel and carboplatin administered every 3 weeks in patients with advanced solid tumors.
S... | Inclusion criteria:
* Patients with advanced solid tumor for which the combination paclitaxel and carboplatin is potentially effective such as lung cancer, epithelial ovarian cancer.
* Patients who have signed and dated an Institutional Review Board (IRB)-approved patient informed consent form prior to study enrollmen... |
Study Objectives
Every day many patients affected by chronic life-limiting illnesses are admitted into Internal Medicine wards, coming from the Emergency Department. Many studies suggest that providing palliative care to these patients may improve their end-of-life care while reducing costs by minimizing futile treatme... | Inclusion Criteria:
Patients admitted to Molinette Hospital (A.O.U. "Città della Salute e della Scienza"), affected by:
* locally advanced/metastatic cancer not suitable to antineoplastic therapy
* locally advanced/metastatic cancer suitable for palliative antineoplastic therapy
* locally advanced/metastatic cancer w... |
Study Objectives
The main objective is to assess the feasibility of an intervention based on medical Ericksonian hypnosis as a complementary therapy in patients treated with surgery after a diagnosis of breast cancer, followed by an indication of adjuvant chemotherapy and radiotherapy
Intervention / Treatment
BEHAVIOR... | Inclusion Criteria:
* * Female, age > 18 years-old
* Without previous practice of hypnosis
* Patient with diagnosis of breast cancer
* Patient receiving an adjuvant chemotherapy for at least 3 months with an indication of radiotherapy after chemotherapy
* Patient accepting the principle of the study with a si... |
Study Objectives
A study to assess the pharmacokinetics, safety and tolerability of Selumetinib (AZD6244, ARRY-142886) in patients with hepatic impairment and healthy subjects.
Intervention / Treatment
DRUG: Selumetinib 50mg, DRUG: Selumetinib 25mg
| Inclusion Criteria for all participants:
* Subjects will be males or females (non-childbearing potential) aged 18 years or more and with a weight of at least 45 kg and a BMI between 18 and 40 kg/m2 inclusive.
Inclusion Critera only for hepatic impaired patients:
* Subjects with stable liver cirrhosis and hepatic i... |
Study Objectives
Polycystic ovary syndrome (PCOS) is the most common endocrinopathy in women, primarily affecting the reproductive system, with substantial collateral negative health effects on metabolic, psychological, and cardiovascular functions. Patients with this syndrome are at higher risk of developing insulin r... | Inclusion Criteria-
* females of adolescent and adult age groups newly diagnosed with PCOS(according to Rotterdam criteria), with >16 natural teeth.
* age range (11-19Year) for adolescent age group
* age range (20-40Year) for adult age group..
Exclusion Criteria:
* Patients with any history of thyroid dysfunction, h... |
Study Objectives
The aim of this study is to evaluate the Sentimag/Sienna+ System (Sentimag®) in clinical routine practice. On the one hand this allows evaluation of the equivalence of the two techniques. On the other hand this ensures that patients do not experience any possible disadvantages by participating. The hyp... | Inclusion Criteria:
* Patients with primary breast cancer scheduled for Sentinel node biopsy;
* Patients who are clinically and radiologically node negative;.
* Patients aged ≥18 years at time of consent
* Patients are able and willing to give informed consent
* Ability and willingness to undertake all scheduled visit... |
Study Objectives
The objective of this prospective randomized surgical trial is to evaluate whether the use of the LIGASURE surgical device during omentectomy and/or recto-sigmoid resection for women with ovarian cancer will reduce the surgical time compared to standard surgical resection using clamps and surgical liga... | Inclusion Criteria:
* Patients must be 18 years or older
* All patients who are suspected to have an early or late stage ovarian cancer during their preoperative evaluation will be potential study participants.
* Potential candidates must have signed an IRB-approved Informed Consent (University of Utah Informed consen... |
Study Objectives
The purpose of this study is to compare the efficacy of AZD6244 in combination with docetaxel versus docetaxel alone in patients with KRAS mutation positive locally advanced or metastatic non small cell lung cancer.
Intervention / Treatment
DRUG: AZD6244, DRUG: docetaxel, DRUG: Placebo
| Inclusion Criteria:
* Locally advanced or metastatic non small cell lung cancer (IIIB-IV)
* Failure of first line anti-cancer therapy (either radiological documentation of disease progression or due to toxicity) in advanced disease or subsequent relapse of disease following first line therapy
* Tumour sample confirmed... |
Study Objectives
The main objective of this study is to evaluate and compare peri-operative outcomes of lobectomy compare with different approaches. The study aims to include patients with stage IA, IB, IIA, IIB and IIIA lung cancer that underwent lobectomy via robotic-assisted, VATS and open approach.
Intervention / ... | Inclusion Criteria:
* Subject is 18 years or older
* Subject who has undergone elective robotic-assisted, VATS or open lobectomy for clinically diagnosed primary stage IA, IB, IIA, IIB and IIIA lung cancer, with or without neo-adjuvant therapy
Exclusion Criteria:
* Subject with stage IIIB lung cancer
* Subject who r... |
Study Objectives
The purpose of this epidemiologic study is to establish a population-based cohort of women with advanced stage breast cancer which can be used to quantify the frequency and timing of brain metastases, and other distant metastases, in this patient population.
Intervention / Treatment
DRUG: Trastuzumab ... | Inclusion Criteria:
* Initially diagnosed with American Joint Commission on Cancer (AJCC) stage III or stage IV breast cancer between January 1, 1995 through December 31, 2007 -OR- diagnosed with AJCC stage I or II breast cancer and progressed to stage III or IV disease between January 1, 1995 through December 31, 200... |
Study Objectives
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have esophageal or stomach cancer.
Intervention / Treatment
DRUG: irinotecan hydrochloride
... | Inclusion Criteria:
* Patients must be > 18 years of age
* Patients must have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
* Patients must have a predicted life expectancy of at least 12 weeks
* Patients must have a pretreatment granulocyte count of >1500/mm3, a hemogl... |
Study Objectives
This study is aimed at assessing the efficacy of Apraclonidine eye drops in the treatment of ptosis secondary to myasthenia gravis.
Intervention / Treatment
DRUG: Apraclonidine Hcl 0.5% Oph Soln
| Inclusion Criteria:
* Patients aged 18 or older with a diagnosis of ocular or generalized myasthenia gravis with ocular involvement.
Exclusion Criteria:
* Patients receiving mono-amino-oxidase inhibitors.
* Patients with history of hypertension, cardiac, or cerebrovascular disease.
* Women with confirmed pregnancy. |
Study Objectives
Research indicates that up to two-thirds of patients with advanced cancer experience significant symptom burden (e.g., anxiety and depression, pain, fatigue), yet these symptoms are not adequately addressed. Cognitive behavioral therapy (CBT) protocols designed to teach patients strategies to increase ... | Inclusion Criteria:
* At least 21 years old
* Have a diagnosis of stage IV breast cancer
* Able and willing to attend program sessions
* Able to speak and read English
Exclusion Criteria:
* Active serious mental illness (e.g., schizophrenia, bipolar disorder) indicated by medical records
* Visual, hearing, or cognit... |
Study Objectives
Estimate the rate of occurrence of Invasive Fungal Infections (IFIs) in patients with acute leukemia for the first 6 months of chemotherapy (that usually correspond to four courses of chemotherapy), and hematopoietic stem cells transplantation.
Intervention / Treatment
| Inclusion Criteria:
* Diagnosed with de novo or relapsed AL (AML, ALL)started chemotherapy
* All newly allogeneic or autologous transplant recipients during the study period |
Study Objectives
No standard approach currently exists for endoscopic esophageal stent placement, and both sutured and un-sutured techniques are employed for esophageal stent placement currently. The primary purpose of this study is to find out if suture fixation of esophageal stents is superior to non-suture fixated s... | Inclusion Criteria:
* Able to provide informed consent
* Indication for esophageal stent placement
Exclusion Criteria:
* Presence of any contraindication to esophageal stent placement
* Incarceration
* Inability to tolerate anesthesia
* Pregnant status |
Study Objectives
Breast cancer is the most frequent in women. Early diagnosis and recent treatments have improved overall mortality. However, chronic pain (pain lasting more than 3 months after surgery) remains a public health problem with impact on quality of life for these patients. The incidence of pain has been rep... | Inclusion Criteria:
* women
* > 18 years old
* with "American Society of Anesthesiologists-ASA" physical status 1 to 3
* with unilateral breast cancer adenocarcinoma treated surgically by conservative tumorectomy associated or not to sentinel lymph node dissection on an ambulatory basis
Exclusion Criteria:
* None |
Study Objectives
This is a retrospective study, including 79 patients with duodenal papillary adenoma, who treated with Endoscopic Papillectomy (EP) at Beijing friendship hospital. The cohort included patients who underwent EP with or without Pancreatic Duct (PD) and Common Bile Duct (CBD) stent placement. The investig... | Inclusion Criteria:
* Age ≥18 years.
* Identification of duodenal papillary lesions via gastroscopy or duodenoscopy.
* Intraductal involvement <20mm.
* Absence of preoperative peripheral lymph node metastasis and pancreatic/biliary duct stenosis (verified by CT, MRI, or other imaging).
* Postoperative biopsy confirmin... |
Study Objectives
The study objective is to evaluate the feasibility of three instillations of immunostimulating gene therapy (AdCD40L) in patients with urinary bladder cancer. Tolerance, toxicity and immunological parameters will be evaluated during and post treatment.
Intervention / Treatment
GENETIC: AdCD40L
| Inclusion Criteria:
* Histologically proven diagnosis of transitional cell carcinoma of the bladder
* ECOG 0-2
* 18 years of age or older
* signed informed consent
* for the Phase I part: patient scheduled for cystectomy
Exclusion Criteria:
* Woman of childbearing potential (fertile woman)
* Other malignancy within ... |
Study Objectives
There are currently no useful tests to identify patients who will respond to cetuximab therapy, notably because EGFR levels do not correlate with the clinical responses observed. Thus, the investigators are investigating the role of cellular immunity and immune escape mechanisms to explain the differen... | Inclusion Criteria:
* Histologically or cytologically confirmed, previously untreated HNC. Clinical stage III or IVA disease without distant metastases as determined by CT, and as defined by the American Joint Committee on Cancer Staging System, Sixth edition (See Appendix I).
* Primary tumors of the oral cavity, orop... |
Study Objectives
Patients eligibility to targeted therapies relies on a molecular test performed on a tumor sample collected by biopsy. This invasive procedure is associated with a relative high risk of morbidity and requires the intervention of a costly and important technical platform. Thus, inoperable patients can b... | Inclusion Criteria:
* Age 18 years old or older
* Histologically confirmed stage IIIb/IV non-squamous NSCLC undergoing biopsy or surgery
* Presence of ALK rearrangement result by FISH analysis (gold standard method) on tumor tissue
* Signed specific informed consent approved by the Institutional Review Board prior to ... |
Study Objectives
Acute lymphoblastic leukemia (ALL) is the most common malignant disease in childhood. Today more than 90% of children and 75% of adults (18-45 years) survive ALL. The enzyme Asparaginase (Asp) is an indispensable part of the multiagent treatment of ALL.
Treatment related severe acute toxicities are co... | Inclusion Criteria:
* Treated on the ALL2008 protocol for ALL. Had a DVT on treatment.
Exclusion Criteria:
* Death |
Study Objectives
The aim of this study was to evaluate the impact of low dose liraglutide in combination with metformin compared to metformin alone on IVF pregnancy rate (PR) and cumulatively PR (IVF and spontaneous) in infertile obese women with PCOS who had been previously poor responders regarding weight reduction w... | Inclusion Criteria:
* 18 years old to 38 years old
* polycystic ovary syndrome (rotterdam criteria)
* BMI of 30 kg/m² or higher
* Infertility
* Before IVF
Exclusion Criteria:
* type 1 or type 2 diabetes mellitus
* history of carcinoma
* Cushing's syndrome or congenital (non-classic) adrenal hyperplasia
* pers... |
Study Objectives
This is a dose-finding study; therefore, there is no hypothesis testing
Intervention / Treatment
DRUG: Paclitaxel + Carboplatin + CP-870,893, DRUG: Paclitaxel + Carboplatin + CP-870,893
| Inclusion Criteria:
* Patients with metastatic solid tumors, for whom carboplatin and paclitaxel are appropriate;
* Patients >18 years of age;
* Good performance status;
* Adequate bone marrow and organ function
Exclusion Criteria:
* Previous treatment with any other compound that targets CD40
* Current or planned c... |
Study Objectives
The aim of this study is to compare the diagnostic yield of intermittent versus continuous suction in the diagnosis of pancreatic solid lesions.
Intervention / Treatment
PROCEDURE: Intermittent aspiration
| Inclusion Criteria:
* Pancreatic solid lesion
* Patients over 18 years old
* Suitable for endoscopy
Exclusion Criteria:
* Contraindication for endoscopy
* Active anticoagulant therapy
* Thrombocytopenia or coagulopathy in the absence of its correction prior to the procedure
* Absence of informed consent
* Pregnancy
... |
Study Objectives
The primary objective is:
* To determine the efficacy of modafinil in the reduction of fatigue in patients with metastatic breast or prostate cancer undergoing docetaxel-based chemotherapy
The secondary objectives are:
* To determine the effect of modafinil on quality of life (QoL) during docetaxel-... | Inclusion criteria:
* Treatment with q3w (every three weeks) docetaxel-based chemotherapy for metastatic breast or prostate cancer at a minimum dose of 50 mg/m2
* Completed at least two cycles of chemotherapy and intention to treat the patient with at least two further cycles of docetaxel-based chemotherapy
* Fatigue ... |
Study Objectives
In this study a previously described structured multimodality image report system for the characterization of focal bone lesions is evaluated in a larger patient population. The objective of this study is to evaluate the performance of this tool stratifying the malignancy risk of bone tumors.
Interven... | Inclusion Criteria:
* Patient evaluated for the initial imaging characterization of a focal bone lesion.
* Availability of conventional radiographs or a CT study for patients with lesions in the spine, pelvis or calvarium.
* Availability of a contrast enhanced MRI study.
Exclusion Criteria:
* Prio surgery
* History ... |
Study Objectives
In this study, effects of γδT cells on human non small lung cancer ( without EGFR mutation) in combination with tumor reducing surgery, for example cryosurgery going to be investigated.
Intervention / Treatment
BIOLOGICAL: DC-CIK, BIOLOGICAL: γδ T Cell, BIOLOGICAL: γδ T/DC-CIK cells
| Inclusion Criteria:
* Age:18-75
* Karnofsky performance status >50
* Diagnosis with non small lung tumors based on histology or the current accepted radiological measures.
* Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ Will receive cryosurgery, gd Tcells/ DC-CIK.
* Life expectancy: Greater th... |
Study Objectives
This phase II trial studies how well sapanisertib works in treating patients with pancreatic neuroendocrine tumor that has spread to other places in the body (metastatic), does not respond to treatment (refractory), or cannot be surgically removed. Drugs such as sapanisertib may stop the growth or shri... | Inclusion Criteria:
* Patients must have unresectable or metastatic, histologically confirmed low or intermediate grade (Klimstra Criteria) pancreatic neuroendocrine tumor (PNET) with radiological evidence of disease progression since last treatment
* Refractory disease to treatment with an mTOR inhibitor
* Patients w... |
Study Objectives
This is a Phase Ib/IIa, open-label, non-randomized, dose-escalation, multi-center study to evaluate the safety, tolerability, pharmacokinetics (PK), and clinical activity of oral GSK2636771 in combination with intravenous (IV) paclitaxel in two independent subject populations: subjects with PTEN-defici... | Inclusion criteria:
* histologically or cytologically confirmed diagnosis of advanced gastric adenocarcinoma
* Has a PTEN-deficient tumor as documented from archival or fresh (from biopsy) tumor tissue or has shown genomic alterations in PI3K pathway genes (PIK3CB, PI3KR1, PTEN, etc.) as assessed in a local laboratory... |
Study Objectives
This study is designed to investigate whether complement C3 depletion is associated with poor short-term outcomes in postoperative patients with gastric cancer.
Intervention / Treatment
PROCEDURE: gastrectomy plus D2 lymphadenectomy, DRUG: S-1+Oxaliplatin
| Inclusion Criteria:
* Pathological diagnosis of gastric adenocarcinoma
* Radical operation and adjuvant chemotherapy endurable
* Informed consent approved
Exclusion Criteria:
* Age <18 or >75 years old
* Pregnancy or lactating woman
* Any primary diagnosis other than gastric cancer
* Confirmed complement deficiency ... |
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