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{ "NCT_ID" : "NCT01488045", "Brief_Title" : "Compare Propofol to Fentanyl and Midazolam for Colonoscopy", "Official_title" : "Randomized Trial to Compare Propofol to Fentanyl and Midazolam for Colonoscopy.", "Conditions" : ["Colon Cancer", "Rectal Cancer", "Colonic Diverticulosis"], "Interventions" : ["Drug: Midazolam", "Drug: Fentanyl", "Drug: Propofol"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "SINGLE" } }

#Study Description Brief Summary The study aim is to determine if Propofol or the combination of Fentanyl and low-dose Midazolam, are equivalent for patient satisfaction and discomfort when undergoing a colonoscopy. This is a prospective randomized study of 262. The primary outcome of this study is participant's satisfaction and discomfort of the colonoscopy procedure as perceived by the participant, and the secondary outcome will be the discomfort of the patient and difficulty of the procedure as perceived by the physician. Detailed Description Background The use of colonoscopy has become an important diagnostic and therapeutic tool in the evaluation of multiple medical conditions of the gastrointestinal tract. Despite its widespread use, there continues to be debate concerning the best pharmacologic approach to patient satisfaction and discomfort of the procedure and to minimize side effects. Aim Two standard pharmacologic (Propofol or Fentanyl and low-dose Midazolam) approaches for colonoscopy will be evaluated systematically to determine if these two approaches are equivalent in terms of patient rating of satisfaction and patient discomfort to the procedure and side effects Study Design This is a prospective randomized study of 262 participants undergoing outpatient colonoscopy at an independent academic medical center. The primary outcome of this study is participant's satisfaction, and the secondary outcome is discomfort of the patient as perceived by the physician performing the procedure. Other Variables of Interest. * Duration of procedure as defined by time the patient arrives in the room to the time the patient is appropriate for discharge. * Difficulty of procedure rated by the physician on a scale of 0-10 * Colonoscopy completion rates (intubation of cecum). * Complications including oxygen desaturation or hypotension. * Cost of the two medication regiments #Intervention - DRUG : Fentanyl - Fentanyl will be administered IV according to standard procedure for colonoscopy. Initial dose will consist of no more than 50µg of Fentanyl. Patient response will be monitored for 30-60 seconds of observation before deciding to administer more Fentanyl in no more than 50µg increments. increments. - Other Names : - Durogesic, Duragesic, Matrifen - DRUG : Propofol - Propofol will be administered IV according to standard procedure for colonoscopy. The initial bolus of propofol will be up to 60 mg IV. Patient response will be monitored for 30-60 seconds of observation before deciding to administer more sedation in 10-20 mg boluses. - Other Names : - Diprivan - DRUG : Midazolam - Midazolam will be administered IV according to standard procedure for colonoscopy. Initial dose will consist of no more than 2 mg of Midazolam. Patient response will be monitored for 30-60 seconds of observation before deciding to administer more Midazolam in no more than 2 mg increments. - Other Names : - Versed

#Eligibility Criteria: Inclusion Criteria: * Age > 18 * Elective outpatient colonoscopy * American Society of Anesthesiology Class (ASA) < IV Exclusion Criteria: * Age < 18 * Inpatient status * Emergency procedure * History of colonic or rectal resection * History of hypersensitivity to Propofol (or soy or egg products),Fentanyl or Midazolam * ASA of IV * Neurological deficit * Acute gastrointestinal bleeding * On anticoagulation agents * Noncompliance with bowel regiment * Pregnant women * Prisoners Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01488045

{ "NCT_ID" : "NCT02909530", "Brief_Title" : "Comparison Between Olympus EZ Shot 3Plus 19G and EZ Shot 2 19G in EUS-guided FNB of Solid Pancreatic Masses", "Official_title" : "Comparison Between the Olympus EZ Shot 3Plus 19G and EZ Shot 2 19G in Endoscopic Ultrasound-guided Fine Needle Biopsy of Solid Pancreatic Masses", "Conditions" : ["Pancreatic Neoplasms"], "Interventions" : ["Device: EUS-FNB with EZ Shot 2 19G first", "Device: EUS-FNB with EZ Shot 3Plus first"], "Location_Countries" : ["Germany"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "RANDOMIZED", "Interventional Model" : "CROSSOVER", "Masking" : "NONE" } }

#Study Description Brief Summary Endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) is a valid and recommended technique for tissue diagnosis of pancreatic masses. However, the diagnostic yield is with a sensitivity of 64%-95% and an accuracy of 78%-94% still very low. The EUS-FNB of pancreatic masses is usually performed with a 22-gauge biopsy needle. The small diameter of the needle is usually responsible for the low yield of tissue samples for histopathological examination. The 19-gauge needles help to overcome the limitations of a 22-gauge needle by acquiring a larger amount of cellular material. Thus, performing EUS-FNB with a 19-gauge needle can maximize tissue acquisition and sample adequacy, which is important for appropriate diagnosis. Contrariwise, the technical success rate for sample retrieval in patients with pancreatic head lesions is significantly lower using the 19-gauge compared to the 22-gauge needle. This is attributable to the technical difficulty to push the needle out of the endoscope in the duodenum. Since about 60% of pancreatic cancers are located in the head region, it is therefore particularly important to improve technical success in these cases. The new 19-gauge biopsy needle 'Olympus EZ Shot3 Plus' is more flexible than common biopsy needles such as 'EZ Shot2' and should therefore provide improved access to regions like pancreatic head. The aim of this multicenter prospective randomized crossover study is to compare those two needles during EUS-FNB of solid pancreatic masses. Therefore this study will enroll 40 patients in five German centers with solid pancreatic masses and consecutive indication for EUS-FNB. Both needles will be used in each patient following a predetermined random order. Primary endpoint is the correct histological diagnosis of the mass assessed by each needle. Technical failure is regarded as a negative histological diagnosis. Secondary endpoints include a comparison of technical failure using each needle, histological quality, duration of procedure and rate of adverse events. #Intervention - DEVICE : EUS-FNB with EZ Shot 3Plus first - Both needles (EZ Shot 3Plus 19G and EZ Shot 2 19G) will be used for endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) in each patient following a predetermined random order which needle is used to pass through the tumor first. - DEVICE : EUS-FNB with EZ Shot 2 19G first - Both needles (EZ Shot 3Plus 19G and EZ Shot 2 19G) will be used for endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) in each patient following a predetermined random order which needle is used to pass through the tumor first.

#Eligibility Criteria: Inclusion Criteria: * solid pancreatic mass and consecutive indication for EUS-FNB Exclusion Criteria: * incapacity to give informed consent * Haemorrhagic disease, disorder of hemostasis and coagulation (PT <60%, PTT> 42 sec. and platelets <60000/µL) * oral anticoagulants * dual antiplatelet therapy with thienopyridines (e.g. clopidogrel) * Pregnant or lactating Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT02909530

{ "NCT_ID" : "NCT00129376", "Brief_Title" : "Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Docetaxel as Neoadjuvant Treatment of Breast Cancer Patients", "Official_title" : "Multicenter Phase II Trial of Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Docetaxel (T) as Neoadjuvant Treatment for Operable Stage II and IIIA Breast Cancer Patients", "Conditions" : ["Breast Cancer"], "Interventions" : ["Drug: Docetaxel", "Drug: Doxorubicin", "Drug: Cyclophosphamide"], "Location_Countries" : ["Spain"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Treatment consists of 4 AC cycles followed by 2 weekly docetaxel cycles (12 infusions). The pathological complete response rate obtained in previous studies is around 12%. The expected pathological complete response rate in this study is 25%. With an alpha error of 0.05 and a beta error of 0.2, and following Simon´s 2 phase test, 19 patients are needed initially. With 2 pathological complete responses, patient recruitment will continue until approximately 61 patients are recruited. Twelve pathological complete responses are needed to confirm the study hypothesis. Detailed Description Patients received doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2), both in a short intravenous infusion, every three weeks for four cycles (days 1, 22, 43 and 64). Three weeks later, docetaxel (36 mg/m2) was administered as a 30-min intravenous infusion, weekly for six weeks (days 85, 92, 99, 106, 113 and 120) followed by a 2-week resting period (8-week cycle). After that, patients received a second docetaxel cycle (infusions on days 141, 148, 155, 162, 169 and 176). Adjuvant chemotherapy and radiotherapy were delivered according to the protocol of each participating center. Hormonal treatment was started after the last chemotherapy infusion in all patients with positive estrogen and/or progesterone receptor tumors and was continued for five years. Semiquantitative determination of three molecular markers was carried out by immunocytochemical methods. Tissue samples were taken prior to initiation of chemotherapy from the core of the primary tumors. Specimens were sent to a central laboratory for analysis of Topo II, survivin and p27. #Intervention - DRUG : Doxorubicin - Other Names : - adriamycin - DRUG : Cyclophosphamide - Other Names : - Cytoxan - DRUG : Docetaxel - Other Names : - Taxotere

#Eligibility Criteria: Inclusion Criteria: * Written informed consent. * Patients with breast cancer stages II and IIIA, with histological diagnoses as per true-cut or open biopsy. * Negative extension study, including bilateral mammography, thoracic x-ray, computed tomography (CT)-scan or abdominal echography and bone scintigraphy. * Analysis of hormone receptor status in primary tumour. It is highly recommended to obtain a tumour tissue sample before start of treatment, and after definitive surgery. These samples will be analysed centrally by Spanish Breast Cancer Research Group (GEICAM). * Age >= 18 and <= 70 years. * Performance status as per Karnofsky index >= 80. * Minimum life expectancy of 6 months. * Electrocardiogram (EKG) 12 weeks before registration to the study. If abnormalities are suspected, cardiac function must be assessed by left ventricular ejection fraction (LVEF). * Haematology: neutrophils >= 2.0 x10^9/l; platelets >= 100 x10^9/l; hemoglobin >=10 g/dl. * Hepatic function: total bilirubin <= 1 x upper normal limit (UNL); Aspartate aminotransferase (AST) (SGOT) and and Alanine aminotransferase (ALT) (SGPT) <= 2.5 x UNL; alkaline phosphatase <= 5 x UNL. * Renal function: creatinine <= 1.5 x UNL; creatinine clearance >= 60 ml/min. * Patients able to comply with study requirements. * Negative pregnancy test. * Adequate contraceptive method during the study and up to 3 months after definitive surgery. Exclusion Criteria: * Previous systemic therapy for breast cancer treatment. * Previous treatments with anthracyclines or taxanes for any malignancy. * Previous radiotherapy for breast cancer. * Bilateral invasive breast cancer. * Pregnant or lactating women. * Previous motor or sensorial neurotoxicity grade >=2. * Other serious pathologies: congestive heart failure or angina pectoris; history of myocardial infarction in the previous year; uncontrolled hypertension (HT) or high risk arrhythmias. * History of neurological or psychiatric impairment, precluding patients from providing free informed consent. * Active infection. * Active peptic ulcer; unstable diabetes mellitus. * History of previous or current malignancies other than breast cancer, except for basal skin carcinoma, cervical in situ carcinoma, other tumour diagnosed and treated more than 10 years before, ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS). * Chronic treatment with corticoids unless the treatment started > 6 months before registration to the study, and low doses are administered. * Substitutive hormonal therapy. This treatment must be interrupted before inclusion in the study. * Concomitant treatment with other investigational products or administration in the 30 previous days. * Males. Sex : FEMALE Ages : - Minimum Age : 18 Years - Maximum Age : 70 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT00129376

{ "NCT_ID" : "NCT01593618", "Brief_Title" : "Empowering Cancer Survivors Through Information Technology", "Official_title" : "Empowering Cancer Survivors Through Information Technology", "Conditions" : ["Cancer Survivor"], "Interventions" : ["Behavioral: UMFollowUp", "Other: Standard of Care"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a randomized controlled trial of a web-based informational intervention (UMFollowUp) for adolescent and young adult survivors of childhood cancer to improve cancer knowledge and psychosocial functioning. Detailed Description Individuals randomly assigned to the control group will receive standard of care for the duration of their participation. This means they will continue to receive information regarding their diagnosis, treatments and ongoing health needs from their provider (no access to website). Individuals randomly assigned to the treatment group will receive access to UMFollowUp, a secure, HIPAA-compliant website. All participants will be asked to complete paper-and-pencil surveys at baseline and 9 months later to determine the impact of the web-based intervention. #Intervention - BEHAVIORAL : UMFollowUp - Web-based internet resource for self-reported treatment summaries and psychosocial and physical well-being. - OTHER : Standard of Care - Patients will receive information regarding their diagnosis, treatments, and ongoing health needs from their provider, but will not be provided access to the website.

#Eligibility Criteria: Inclusion Criteria: * History of diagnosis of hematologic malignancy or malignant neoplasm, and in disease free remission at time of recruitment. * Must be English-speaking and have access to a computer with internet access, and must have completed treatment at University of Minnesota Medical Center-Fairview for cancer. Exclusion Criteria: * Individual with significant visual impairments and neurologic/cognitive difficulties which limit their ability to see and under our outcome questionnaires or website content will be excluded from participation. Sex : ALL Ages : - Minimum Age : 15 Years - Maximum Age : 28 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD Accepts Healthy Volunteers: No

NCT01593618

{ "NCT_ID" : "NCT01084837", "Brief_Title" : "Study of Induction Treatment With Velcade and Dexamethasone for Previously Untreated Patients With Multiple Myeloma and Renal Failure", "Official_title" : "A National, Multicentric, Open-label Study of Induction Treatment With VELCADE and Dexamethasone for Previously Untreated Patients With Multiple Myeloma and Renal Failure", "Conditions" : ["Multiple Myeloma"], "Location_Countries" : ["Spain"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Primary outcome measure: * Analyze the efficacy (in order to evaluate the response) of Bortezomib/Dexamethasone treatment Secondary outcome measures: * Study the speed of response and the response rate (M component in serum and urine protein) after each bortezomib/dexamethasone cycle * Compare the efficacy of the bortezomib/dexamethasone therapy against the therapy without bortezomib * Reversibility of renal failure * Predictive value in the light chain determination for response and reversibility of renal failure * Early morbidity (\< 2 months) * Progression-free survival * Overall survival The safety outcome consists in: * Determining the safety and tolerance of VELCADE/Dexamethasone, according to the toxicity criteria of clinical and laboratory events Detailed Description 60 patients, 18 years or older, diagnosed with newly symptomatic multiple myeloma (standard diagnosis criteria) and renal failure, previously untreated with chemotherapy, will be included. It is an multi centric, national and open study designed in order to determine efficacy of the combination of bortezomib and dexamethasone for multiple myeloma patients with renal failure. The trial consists of two parts: pre-treatment and treatment. Pre- treatment phase: include the enrolment visit in order to determine that the patient is eligible to participate in a study. The patient will be given the Informed Consent Form in order to participate in the study, and detailed information about the treatment, its benefits and risks. Treatment phase: include the treatment which consist of, at the most, 12 cycles of Velcade and Dexamethasone (induction and extension). During these periods, patients will come to the centre for the study visits to be evaluated, the days they will receive Velcade® of each cycle. Once the clinical trial has finished, patients will be monitored during short and long-term periods where progression free survival and overall survival will be evaluated. #Intervention - DRUG : velcade - INDUCTIoN (Cycles 1-4) * Bortezomib 1,3 mg/m2 i.v. days 1, 4, 8 and 11 follow by 10 days without treatment * Dexamethasone 40 mg/p.o. days 1-4 and 9-12 cycles 1-4 (Cycles of 21 days) For patients wich is not planned autotransplantation, add: Cycles 5-8 * Bortezomib 1,3 mg/m2 i.v. days 1, 4, 8 and 11 follow by 10 days without treatment * Dexamethasone 40 mg/v.o. days 1-4 (Cycles of 21 days) EXTENSION TREATMENT(Cycles 9-12) * Bortezomib 1,3 mg/m2 i.v. days 1, 8, 15 and 22 * Dexamethasone 40 mg/d v.o. days 1-4 (Every 6 weeks)

#Eligibility Criteria: Inclusion Criteria: * The patient must, according with investigator criteria, be able to comply with all the protocol requirements * The patient or legal representative must sign voluntarily the informed consent before the performance of any study related procedure, not part of usual medical care, with the knowledge that can leave the study the moment he/she wants, without prejudice to later medical care * 18 years and older * Patients with newly diagnosed symptomatic multiple myeloma43 which hasn't been treated previously with any chemotherapy used for this disease (see Annex 8) * Patient with a measurable or evaluable disease, defined as follows: * For secretor multiple myeloma, measurable disease is defined as any quantifiable serum monoclonal protein value of IgG>10g/l or IgA > 5 g/l and, where applicable, urine light-chain excretion of >= 200 mg/24 hours * For oligo or non-secretor multiple myeloma, measurable disease is defined by the presence of soft tissue plasmocytomas (not bone) determined by clinical examination or applicable radiographs (i.e. MRI, CT-Scan). In patients with low secretor multiple myeloma, the serum and/or urine M-protein measurements are very low and difficult to follow for response assessment. In patients with non-secretor multiple myeloma, there is no M-protein in serum or urine by immunofixation * ECOG performance status <= 2 (see Appendix 5) * Patient has a life-expectancy >3 months * Glomerular filtration calculated with MDRD <50 ml/min * Patient has the following laboratory values during the 14 days before first dose: * Platelet count >= 50x109/l * Absolute neutrophil count (ANC) >= 0.75 x 10 9/ L * Corrected serum calcium (see Appendix 15) <= 14mg/dl * Aspartate transaminase (AST): <= 2,5 x upper limit of normal * Alanine Aminotransferase (ALT): <= 2,5 x upper limit of normal * Total bilirubin: <= 1,5 x upper limit of normal Exclusion Criteria: * Glomerular filtration calculated with MDRD >= 50ml/min * Asymptomatic MM with renal failure from unrelated causes * Prior Velcade therapy * Patients previously received treatment to Multiple Myeloma * Patient had major surgery within 4 weeks previous inclusion * Patient with platelet count <= 50 x 109/l within 14 days before enrolment * Patient with absolute neutrophil count <= 0,75x109/l within 14 days before enrolment * Patients with Grade 2 peripheral neuropathy within 14 days before enrolment * Patient has hypersensitivity to bortezomib, boron or mannitol * Patient has received other investigational drugs within 14 days before enrolment * Patient is known to be seropositive for the human immunodeficiency virus (HIV) * Patient had a myocardial infarction within 6 months before of enrolment or has Class III or IV heart failure (New York Heart Association <NYHA>), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiography evidence of acute ischemia or active conduction system abnormalities, or other heart condition which, according with the specialist, can result in heart failure * Patient is enrolled in another clinical research study and/or is receiving an investigational agent for any reason * Patients with diffuse pulmonary disease and/or pericardial disease * Pregnancy or breast-feed women and women of childbearing age that don't accept to use anticonceptive methods since beginning during all the study until 30 days after last cycle treatment. Fertile male patients must use effective form of contraception since enrolment, during and until 30 days after last cycle study treatment * Patient with a previous clinical history of another malign illness except for squamous cell carcinoma or skin cancer or cervical or breast cancer) except the patient could be free of symptoms during >= 5 years * Uncontrolled arterial hypertension or diabetes mellitus or other serious medical condition which places the subject at unacceptable risk or other psychiatric illness that would prevent the subject from understanding the informed consent form Sex : ALL Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT Accepts Healthy Volunteers: No

NCT01084837