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{ "NCT_ID" : "NCT00588081", "Brief_Title" : "Immediate Vaginal Reconstruction After Oncologic Resection: Surgical Outcomes, Patient Satisfaction and Sexual Function", "Official_title" : "Immediate Vaginal Reconstruction Following Oncologic Resection: Surgical Outcomes, Patient Satisfaction and Sexual Function", "Conditions" : ["Vaginal Cancer"], "Interventions" : ["Behavioral: QOL"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This study is being done to find out more about the experience women have with vaginal reconstruction. We hope to learn about their quality of life, sexual function, and body image. We would like to find out how happy women are with surgery. We also want to know what things should be changed or improved. Since you have had this surgery, we would like to ask you to take part in an interview. Detailed Description The purpose of this study, entitled immediate vaginal reconstruction following oncologic resection: Surgical outcomes, patient satisfaction and sexual function is to determine postoperative complications, patient satisfaction, quality of life and level of sexual functioning among patients who have undergone vaginal reconstruction following tumor resection and/or pelvic exenteration.This study will have three components: 1) a chart review to determine postoperative complications and anatomic characteristics of the neo-vagina, 2) a postoperative questionnaire consisting of validated survey instruments to assess quality of life, body image and sexual function and 3) a postoperative qualitative interview to examine quality of life after vaginal reconstruction. #Intervention - BEHAVIORAL : QOL - Those women who chose to have an interview will be scheduled for a 45 to 60 minute open-ended interview with a trained research assistant and sign consent at the time of the interview.

#Eligibility Criteria: Inclusion Criteria: * Immediate partial or total vaginal reconstruction with myocutaneous or fasciocutaneous flaps, following pelvic exenteration or tumor resection at MSKCC during the study period from January 1, 1993 to, March 30, 2007. Exclusion Criteria: * None ##Sex : FEMALE ##Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01358045", "Brief_Title" : "Topical Vitamin D3, Diclofenac or a Combination of Both to Treat Basal Cell Carcinoma", "Official_title" : "Topical Vitamin D3, Diclofenac or a Combination of Both to Treat Basal Cell Carcinoma", "Conditions" : ["Basal Cell Carcinoma"], "Interventions" : ["Drug: Diclofenac + Calcitriol", "Drug: Calcitriol", "Drug: Diclofenac"], "Location_Countries" : ["Netherlands"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "SINGLE" } }

#Study Description Brief Summary Basal cell carcinoma (BCC) is the most frequent malignant tumor in Caucasians and the incidence is still increasing with 3-8% each year. Since BCCs generally occur on sun-exposed areas of the skin, the rice in incidence is mainly explained by the increasing exposure to (intermittent) ultraviolet radiation. Surgical excision is still the standard treatment for (micro)nodular BCCs. The costs as well as the increased workload are stressing the health care system even further and posing BCC an important health care problem. Since half of the BCCs arise primarily on the face \& (bald) head and treatment by surgical excision may result in disfiguring scars, patients often experience a dramatic decrease of their quality of life. Hence, there is an urgent medical and societal need for a simple and cheap (targeted) treatment, preferably to be performed by the patients themselves. This treatment must be safe and effective. Such treatment is not available yet. BCC tumorigenesis is complex and must be multifactorial. Genetic alterations of multiple components of the Sonic Hedgehog (SHH) pathway are involved in sporadic BCC pathogenesis; inactivating mutations in Patched-1 (PTCH1) and activating mutations of Smoothened (SMO) and Suppressor of Fused (SU(FU)). With this knowledge, inhibition of the SHH pathway by SMO antagonists was successfully administered, however treatment resulted only in partial clinical response ofBCC. Recently, involvement of the Wingless (Wnt) pathway has been proven to be essential in BCC tumorigenic response. Moreover, a recent study of our own department provides the first evidence that epigenetic alterations, particularly promoter hypermethylation, influence both the SHH and Wnt pathway (own data, not published), which can serve as therapeutic targets. Both non-steroidal anti-inflammatory drugs (NSAlDS) and vitamin D derivatives are able to directly or indirectly target the Wnt pathway. Furthermore, vitamin D3 is able to inhibit Smoothened (SMO) in vitro, resulting in inhibition of the SHH pathway. Although in vivo studies are lacking, the investigators assume that topical application of these drugs may inhibit BCC growth and/or may cure BCC and thus might provide very promising future perspectives. Calcitriol and NSAlDs ointments are both already available for other indications and save in use. Eventually, our approach may result in a systematic approach to BCC, targeting (epi)genetic changes to treat and/or prevent further tumour growth. #Intervention - DRUG : Diclofenac - Application on the lesion 2 times a day 8 weeks. - Other Names : - Solaraze - DRUG : Diclofenac + Calcitriol - Application on the lesion 2 times a day, both ointments, 8 weeks. - Other Names : - Solaraze + Silkis - DRUG : Calcitriol - Application on the lesion, 2 times a day, 8 weeks. - Other Names : - Silkis

#Eligibility Criteria: Inclusion Criteria: * Minimum age 18 years * Primary basal cell carcinoma, histologically confirmed * (Micro) Nodular or superficial histological subtype * Comorbidities may not interfere with study treatment * Capable to understand instructions Exclusion Criteria: * Age under 18 years * Tumors located at the H-zone of the face * Deficient histological conformation * Proven or suspected malignancy of other organs * Not capable of comprehending instructions * Incompetent * Use of oral NSAlDs during the trial period or within 30 days before starting therapy * Use of oral vitamin D (containing) supplements during the trial period or within 30 days before starting therapy ##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

{ "NCT_ID" : "NCT00948935", "Brief_Title" : "Study of Gemcitabine, Irinotecan and Panitumumab in Patients With Advanced and Metastatic Biliary Tract Adenocarcinoma", "Official_title" : "Phase II Combination of Gemcitabine (Fixed Dose-rate Infusion, FDR), Irinotecan and Panitumumab in Patients With Advanced and Metastatic Biliary Tract Adenocarcinoma", "Conditions" : ["Biliary Cancer", "Cholangiocarcinoma"], "Interventions" : ["Drug: Gemcitabine, Irinotecan, Panitumumab"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This study evaluates the combination chemotherapy with gemcitabine, irinotecan and panitumumab in patients with advanced biliary cancer. #Intervention - DRUG : Gemcitabine, Irinotecan, Panitumumab - Gemcitabine 1000 mg/m2 over 100 minutes(Days 1, 8), irinotecan 100 mg/m2 IV over 60 minutes(days 1, 8) and panitumumab 9 mg/kg IV (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities.

#Eligibility Criteria: Inclusion Criteria: * histologically or cytologically confirmed local advanced unresectable/metastatic adenocarcinoma of biliary tract * measurable disease * available tumor tissue for investigational immunohistochemical evaluations * ECOG PS 0 <= age <= 2 * No prior chemotherapy, biologic therapy or radiation therapy * Age Eighteen and older * Lab values per protocol Exclusion Criteria: * Life expectancy less than three months * Concurrent use of chemotherapy not indicated in the study protocol or any other investigational agents and patients who have received investigational drugs less than four weeks prior to enrollment * Prior therapy, which affects or targets the EGF pathway * Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer * Recovery from major surgery within three weeks of the start of study treatment ##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

{ "NCT_ID" : "NCT03069313", "Brief_Title" : "Vitamin B12 for Aromatase Inhibitors Musculoskeletal Symptoms", "Official_title" : "A Single Arm Phase II Study of Oral Vitamin B12 for the Treatment of Aromatase Inhibitors (AI) Associated Musculoskeletal Symptoms in Women With Early Stage Breast Cancer", "Conditions" : ["Relief of Joint Pain"], "Interventions" : ["Dietary Supplement: Vitamin B12"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Significant Aromatase Inhibitor-associated toxicity, affects as many as 50% of patients with breast cancer leading to early discontinuation of this life-saving cancer treatment. No effective pharmacologic therapy has yet been identified for management of these symptoms, as many patients do not experience relief of symptoms with analgesic therapy. Vitamin B12, whether as injection or oral forms, has been used as a naturopathic product to provide relief for joint pain caused by arthritis. This effect has not been studied in the setting of Aromatase Inhibitor-Associated Musculoskeletal Symptoms (AIMSS). Detailed Description Primary Objectives: a. To assess whether daily oral Vitamin B12 decreases average joint pain in women with aromatase inhibitor-associated musculoskeletal symptoms (AIMSS), as measured at baseline, 6 weeks and at 12 weeks by the modified Brief Pain Inventory Short Form (BPI-SF). Secondary Objectives: 1. To investigate whether daily vitamin B12 improves functional quality of life as measured by the Functional Assessment of Cancer Therapy-Endocrine Scale (FACT-ES); 2. To explore the impact of treatment on serum inflammatory cytokine levels (C Reactive Protein) with 12 weeks of treatment between baseline and 12 weeks. #Intervention - DIETARY_SUPPLEMENT : Vitamin B12 - Vitamin B12 2500 micrograms sublingually per day over the course of 90 days (+/- 10 days)

#Eligibility Criteria: Inclusion Criteria: * Sign informed consent and Pain level > 4 in the BPI scale, * Stage I-III Exclusion Criteria: * <18 yrs * Stage IV * BPI Score <4 * Zubrod score >2 ##Sex : FEMALE ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00116896", "Brief_Title" : "Phase I Study of Cisplatin Plus OSI-7904L in Patients With Solid Tumors", "Official_title" : "Phase I Study of OSI-7904L in Combination With Cisplatin in Patients With Advanced Solid Tumors", "Conditions" : ["Advanced Solid Tumors"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Masking" : "NONE" } }

#Study Description Brief Summary This is a Phase I, open-label, dose escalation, study of the combination of cisplatin and OSI-7904L given on Day 1 every 21 days in patient who have advanced solid tumors. #Intervention - DRUG : OSI-7904L - DRUG : Cisplatin

#Eligibility Criteria: Inclusion Criteria: * 18 years or older * Advanced and/or metastatic solid tumor for which no effective therapy is available * ECOG performance status 0 <= age <= 2 * Adequate bone marrow, hepatic and renal function Exclusion Criteria: * Patients with active or uncontrolled infections * Neurotoxicity >= Grade 2 * Symptomatic brain metastases which are not stable ##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

{ "NCT_ID" : "NCT06316401", "Brief_Title" : "Endoscopic Submucosal Dissection of Large Recto-sigmoid Lesions Under Spinal Anesthesia", "Official_title" : "Endoscopic Submucosal Dissection of Large Recto-sigmoid Lesions Under Spinal Anesthesia", "Conditions" : ["Colorectal (Colon or Rectal) Cancer"], "Interventions" : ["Procedure: ESD of large LSTs under SA"], "Location_Countries" : ["Italy"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary The investigators collected data on all consecutive patients who underwent ESD for recto-sigmoid laterally spreading tumors (LSTs) \>35 mm under SA between January 2021 and March 2024. The investigators evaluated the technical success and safety of SA in terms of ARAEs, and pain, measured via visual assessment scale (VAS). Detailed Description Background and study aim: Endoscopic submucosal dissection (ESD) of large colorectal lesions requires the patient to be in a still position for a long time. Both deep sedation and general anesthesia carry a substantial risk of anesthesia-related adverse events (ARAEs), especially in frail patients. Conversely, mild-to-moderate sedation does not prevent involuntary movements of the patient. Spinal anesthesia (SA) is a safe and simple technique that provides analgesia and motor block without systemic drug administration or orotracheal intubation. As the use of SA in colorectal endoscopic resections has not been described so far, we aimed to evaluate the feasibility and performance of SA in large (\>35 mm) recto-sigmoid lesion ESD. Patients and methods: The investigators collected data on all consecutive patients who underwent ESD for recto-sigmoid laterally spreading tumors (LSTs) \>35 mm under SA between January 2021 and March 2024. The investigators evaluated the technical success and safety of SA in terms of ARAEs, and pain, measured via visual assessment scale (VAS). The secondary endpoints were as follows: intra- and post-procedural need for additional opioid or other analgesic drug administration, ESD-related adverse eventss, length of hospital stay, and median ESD duration. #Intervention - PROCEDURE : ESD of large LSTs under SA - endoscopic submucosal dissection of large colorectal lesions under spinal anesthesia

#Eligibility Criteria: Inclusion Criteria: * age >=18 years * American Society of Anaesthesiologists (ASA) score I-IV * ability to give informed consent Exclusion Criteria: * age <18 years * ASA score V * allergy to medications used for spinal anesthesia * pregnancy * breastfeeding ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: Yes

{ "NCT_ID" : "NCT00687765", "Brief_Title" : "Study of the Poly (ADP-ribose) Polymerase-1 (PARP-1) Inhibitor BSI-201 in Patients With Newly Diagnosed Malignant Glioma", "Official_title" : "Phase I/II Study of the Poly (ADP-ribose) Polymerase-1 (PARP-1) Inhibitor BSI-201 in Patients With Newly Diagnosed Malignant Glioma", "Conditions" : ["Glioblastoma"], "Interventions" : ["Drug: bsi-201 plus temozolomide"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The phase I portion of study is designed to determine the Maximum Tolerated Dose (MTD) of BSI-201 with two clinically relevant dosing regimens of temozolomide (TMZ). Secondary objectives in the phase I trial include determining the PK of BSI-201 in malignant glioma patients and correlating BSI-201 PK with degree of PARP-1 inhibition. A safety run-in will confirm the safety of BSI-201 added to standard TMZ and radiation therapy and the phase II portion of the study will assess the efficacy and tolerability of the MTD dose of BSI-201 with daily TMZ and radiation therapy followed by adjuvant TMZ in patients with newly diagnosed GBM and assess overall survival as the primary outcome measure. Information on each phase of the study will be listed when each phase opens for enrollment. Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing. #Intervention - DRUG : bsi-201 plus temozolomide - BSI-201 given iv. 2x weekly, temozolomide given orally

#Eligibility Criteria: Inclusion Criteria: * Patients must be at least 18 years * Patients must have a Karnofsky performance status > 60% (i.e. the patient must be able to care for himself/herself with occasional help from others) * Patients must have the following hematologic, renal and liver function (i.e. Absolute neutrophil count > 1500/mm3, Platelets > 100,000/mm3, creatinine < 1.7 mg/dl, total bilirubin <= 1.5 mg/dl, transaminases < 4 times above the upper limits of the institutional normal * Patients must be able to provide written informed consent * Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. Women of childbearing potential must have a negative pregnancy test. The anti-proliferative activity of this experimental drug as well as the standard drug (temozolomide) may be harmful to the developing fetus or nursing infant * Patients must have a Mini Mental Status Exam score of > 15 * Patients must have tumor tissue form completed and signed by a pathologist. See section 9.6 for details Phase I Criteria (Phase I Patients ONLY) * Patients must have histologically proven supratentorial malignant glioma (anaplastic astrocytoma, anaplastic oligodendroglioma or glioblastoma multiforme) * Patients must have received at least 80% of planned temozolomide and radiation therapy with no grade 3 or grade 4 toxicity attributed to the temozolomide * Patients must have received planned treatment with radiation therapy and concomitant temozolomide at least 28 days but no more than 49 days prior to starting treatment on this study * Patients must have Gadolinium MRI or contrast CT scan within 28 days of starting treatment Exclusion Criteria: * Patients with serious concurrent infection or medical illness, which would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety * Patients who are pregnant or breast-feeding. The anti-proliferative activity of this experimental drug and temozolomide may be harmful to the developing fetus or nursing infant * Patients receiving concurrent therapy for their tumor (i.e. chemotherapeutics or investigational agents) * Patients with a concurrent or prior malignancy are ineligible unless they are patients with curatively treated carcinoma-in-situ or basal cell carcinoma of the skin. Patients who have been free of disease (any prior malignancy) for greater than five years are eligible for this study * Patients cannot be receiving cytochrome P450-inducing anticonvulsants (EIAEDs; e.g., phenytoin, carbamazepine, phenobarbital, primidone, oxcarbazepine) and must not have taken them for at least 10 days Phase I Ineligibility Criteria (Phase I Patients ONLY) * Patients who have had repeat craniotomy for tumor therapy after receiving RT and TMZ treatment * Patients who received other chemotherapeutics or investigational agents in addition to their radiation therapy and concomitant temozolomide treatment. Patients who have received Gliadel wafers are eligible for this study ##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

{ "NCT_ID" : "NCT00295646", "Brief_Title" : "Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid", "Official_title" : "Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid, in Premenopausal, Hormone Receptor-positive Breast Cancer Patients (Stage I, II)", "Conditions" : ["Breast Cancer"], "Interventions" : ["Drug: anastrozole", "Other: goserelin", "Drug: zoledronic acid", "Drug: tamoxifen"], "Location_Countries" : ["Germany", "Austria"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The primary objective is, first, the comparison of tamoxifen and anastrozole and, second, the comparison of zoledronate added to standard adjuvant therapy with controls according to disease-free survival (DFS) in premenopausal patients with non-metastatic breast cancer treated with tamoxifen or anastrozole. To assess whether zoledronate added to standard adjuvant therapy can decrease or even prevent bone loss in patients treated with hormonal blockade combined with an antiestrogen or aromatase inhibitor. Detailed Description The trial is conducted as an open multi-center phase III study, in a two-factorial study design and according to Good Clinical Practice (GCP) guidelines. Patients will be randomly assigned to a total of 4 study groups in a 1:1:1:1 assignment ratio. Several stratification criteria will be used in order to ensure balanced distribution of known risk factors. A total of 1.803 patients will be enrolled in 4 arms. Patients will either be treated with anastrozole (1mg daily for 3 years) or tamoxifen (20mg daily for 3 years), and will additionally receive either zoledronate (8mg q4 weeks for 3 years) or no zoledronate (arm A: Nolvadex alone; arm B: Nolvadex plus zoledronate; arm C: Arimidex alone; arm D: Arimidex plus zoledronate). Zoledronate will be administered by i.v. injection at a dose of 4 mg/month for the treatment period of 3 years. Five Bone Mineral Density (BMD) measurements will be performed in a subgroup of patients (404 patients, enrolled in 3 centres). #Intervention - DRUG : tamoxifen - 20 mg/d - Other Names : - Nolvadex - DRUG : anastrozole - 1 mg/d - Other Names : - Arimidex - DRUG : zoledronic acid - 4 mg q6m - Other Names : - Zoledronate, Zometa - OTHER : goserelin - 3.6 mg goserelin subcutaneously every 28 days

#Eligibility Criteria: Inclusion Criteria: * Premenopausal, hormone receptor-positive patient * Histologically verified (minimally) invasive breast cancer, local radical treatment * 0 <= age <= 9 involved axillary lymph nodes (>= 10 histologically examined nodes) * Tumor stage: pT1b-3, yT0 or yT1a Exclusion Criteria: * T1a, T4d, yT4; M1 * Previous breast tumor irradiation * Previous or concurrent chemotherapy (except for preoperative chemotherapy) * Serum creatinine > 1.5 x UNL or creatinine clearance < 60 ml/min ##Sex : FEMALE ##Ages : - Minimum Age : 19 Years - Maximum Age : 59 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01141712", "Brief_Title" : "Autologous Transplant in HIV Patients (BMT CTN 0803)", "Official_title" : "High Dose Chemotherapy With Autologous Stem Cell Rescue for Aggressive B Cell Lymphoma and Hodgkin Lymphoma in HIV-infected Patients (BMT CTN #0803)", "Conditions" : ["Lymphoma", "HIV"], "Interventions" : ["Drug: Melphalan", "Drug: Cytarabine", "Drug: BCNU", "Procedure: Autologous transplant", "Drug: Etoposide"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This study is a Phase II, multicenter trial assessing overall survival after autologous hematopoietic stem cell transplantation using a BEAM transplant regimen (carmustine, etoposide, cytarabine, melphalan) in lymphoma patients with HIV. Detailed Description BACKGROUND: Non-Hodgkin lymphoma (NHL) is an AIDS-defining diagnosis for patients infected with the Human Immunodeficiency Virus (HIV). While the incidence of NHL has decreased amongst HIV-infected patients since the advent of highly-active anti-retroviral therapy (HAART), lymphoma remains a significant cause of death for this patient population. The prognosis for patients with AIDS-related lymphoma is dramatically different in the era of HAART therapy. In a comparison of treatment outcomes for patients treated before and after the advent of HAART, there is a statistically significant improvement in the overall survival of patients treated with HAART. Unfortunately, despite considerable advances in the treatment of AIDS-related NHL, induction-failure and disease relapse remain key challenges. The prognosis for patients with refractory and relapsed NHL is poor with overall survival rates of less than 20 percent for patients treated with non-transplant salvage therapies. Based upon a randomized trial and numerous phase II trials, high-dose therapy with autologous hematopoietic cell transplantation (HCT) has been established as the standard of care for patients with chemotherapy-sensitive relapsed non-Hodgkin lymphoma. DESIGN NARRATIVE: All patients must have chemosensitive disease as demonstrated by response to induction or salvage chemotherapy. Patients must also have less than or equal to 10percent bone marrow involvement after their most recent salvage therapy. Patients cannot have had prior autologous or allogeneic HCT. Patients must initiate conditioning therapy within 3 months of mobilization or bone marrow harvest. Mobilization therapy may be employed per institutional guidelines. Patients must have an adequate autograft to be eligible for the protocol. Patients may not have HIV refractory to pharmacologic therapy. Patients must not have opportunistic infection that is not responding to therapy. Patients will receive Carmustine (BCNU) 300 mg/m\^2 Day -6, Etoposide 100 mg/m\^2 twice a day (BID) on Days -5 to -2, Cytarabine 100 mg/m2 BID on Days -5 to -2, and Melphalan 140 mg/m2 Day -1 followed by autologous HCT. Patients will be followed for 2 years post-transplant. Survival data, time to progression data, progression-free survival data, time to progression after Complete Remission (CR) data, lymphoma disease-free survival data, time to hematopoietic recovery data, hematologic function data, toxicity data, incidence of infections, treatment-related mortality data, immunologic reconstitution data, data assessing the impact of therapy on the HIV reservoir and microbial gut translocation will be recorded and reported periodically to the BMT CTN Data and Coordinating Center (DCC). #Intervention - PROCEDURE : Autologous transplant - Participants will receive the BEAM conditioning regimen followed by autologous HCT. - DRUG : BCNU - Participants will receive BCNU 300 mg/m\^2 Day -6 - Other Names : - Carmustine - DRUG : Etoposide - Participants will receive Etoposide 100 mg/m\^2 BID Days -5 to -2 - Other Names : - VP-16 - DRUG : Cytarabine - Participants will receive Cytarabine 100 mg/m\^2 BID Days -5 to -2 - Other Names : - Depocyt - DRUG : Melphalan - Participants will receive Melphalan 140 mg/m\^2 Day -1 - Other Names : - Alkeran

#Eligibility Criteria: Inclusion Criteria: * Diagnosis of persistent or recurrent World Health Organization (WHO) classification diffuse large B-cell lymphoma, composite lymphoma with > 50% diffuse large B-cell lymphoma, mediastinal B-cell lymphoma, immunoblastic, plasmablastic, Burkitt's or Burkitt-like or classical Hodgkin's lymphoma. Patients transformed from follicular lymphoma are eligible for the study, pending fulfillment of other criteria. * 15 years or older * Three or fewer prior regimens of chemotherapy over the entire course of their disease treatment (including one induction chemotherapy and no more than 2 salvage chemotherapies). Monoclonal antibody therapy and involved field radiation therapy will not be counted as prior therapies. * All patients must have chemosensitive disease as demonstrated by at least a partial response to induction or salvage therapy. * Less than or equal to 10% bone marrow involvement. * Patients with adequate organ function as measured by: a)Cardiac: American Heart Association Class I: Patients with cardiac disease but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain. Additionally, all patients must have a left ventricular ejection fraction at rest greater than or equal to 40% demonstrated by Multi Gated Acquisition Scan (MUGA) or echocardiogram; b)Hepatic: (i) Bilirubin less than 2.0 mg/dL (except for isolated hyperbilirubinemia attributed to Gilbert syndrome or antiretroviral therapy) and alanine transaminase (ALT) and aspartate transaminase (AST) greater than 3x the upper limit of normal; (ii) Concomitant Hepatitis: Patients with chronic hepatitis B or C may be enrolled on the trial providing the above criteria are met. In addition, no active viral replication - undetectable (viral load less than 500 copies/ml) hepatitis B DNA level by PCR and no clinical or pathologic evidence of irreversible chronic liver disease; c)Renal: Creatinine clearance (calculated creatinine clearance is permitted) greater than 40 mL/min; d)Pulmonary: Carbon Monoxide Diffusing Capacity (DLCO), forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) greater than or equal to 45% of predicted (corrected for hemoglobin). * Autologous peripheral stem cell graft with a minimum of greater than or less than 1.5 x 10^6 CD 34+ cells/kg (target greater than or less than 2.0 x 10^6 CD 34+ cells/kg) or if peripheral blood stem cell (PBSC) mobilization fails, cells can be obtained by bone marrow harvest per institutional practices (in cases where bone marrow will be used for transplantation, the required CD34+ dose does not apply and institutional requirements for total nucleated cell dose should apply). * Initiate conditioning therapy within 3 months of mobilization or bone marrow harvest. * Signed informed consent. * Patients on antiretroviral therapies (ARVs) can either have: a) Undetectable HIV viral load (VL less than 50 copies); b) If VL detectable at less than 2000 copies/mL must have review of previous antiretroviral regimens or previous genotypic or phenotypic testing which indicate the ability to fully suppress virus by addition of sensitive drugs. This review will be carried out by the Infectious Disease (ID) specialist caring for the patient; c)If VL detectable at greater than 2000 copies/mL, a current HIV genotype and/or phenotype must be obtained. If a HAART regimen to which the patient's virus is sensitive can be determined based on genotype and previous antiretroviral experience, then the patient will be considered eligible in this regard. This review will be carried out by the ID specialist caring for the patient. Exclusion Criteria: * Karnofsky performance score less than 70%. * Uncontrolled bacterial, viral or fungal infection (currently taking medication and with progression or no clinical improvement). * Prior malignancy in the 5 years prior to enrollment except resected basal cell carcinoma, treated cervical carcinoma in situ or Kaposi's sarcoma: a)Symptomatic Kaposi's sarcoma currently requiring therapy is excluded (patients receiving topical therapy for minimal disease are not included in this definition); b)Prior treatment with topical agents, local radiation, or up to 6 cycles of cytotoxic chemotherapy at least six months prior is permitted; c) Other cancers treated with curative intent less than 5 years previously will not be allowed unless approved by the Medical Monitor or Protocol Chair; d)Cancer treated with curative intent more than 5 years previously will be allowed. * Pregnant (positive β-HCG) or breastfeeding. * Fertile men or women unwilling to use contraceptive techniques from the time of initiation of mobilization until six-months post-transplant. * Prior autologous or allogeneic HCT. * Patients with evidence of Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) or abnormal cytogenetic analysis indicative of MDS on the pre-transplant bone marrow examination. Pathology report documentation need not be submitted. ##Sex : ALL ##Ages : - Minimum Age : 15 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00667615", "Brief_Title" : "Trial of Vorinostat in Combination With Cyclophosphamide, Etoposide, Prednisone and Rituximab for Elderly Patients With Relapsed Diffuse Large B-Cell Lymphoma (DLBCL)", "Official_title" : "A Multi-Center Phase I/II Trial of Vorinostat in Combination With Cyclophosphamide, Etoposide, Prednisone and Rituximab for Elderly Patients With Relapsed Diffuse Large B-Cell Lymphoma (DLBCL)", "Conditions" : ["Hodgkin's Disease", "Lymphoma"], "Interventions" : ["Drug: rituximab, cyclophosphamide, etoposide, prednisone, vorinostat and QOL questionnaire, peg-filgrastim or filgrastim"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to replace a drug with many side effects, procarbazine, with a new novel drug, vorinostat, in a drug combination for the treatment of patients with diffuse large B-cell lymphoma. Vorinostat is the first of a new type of chemotherapy drug, known as a histone deacetylase inhibitor, to be approved by the Food and Drug Administration. It is approved for the treatment of certain lymphomas of the skin. It alters the cancer cell pathway by preventing cancer cells from reproducing. Vorinostat will be added to a combination of four other effective chemotherapy drugs that have been used for many years for the treatment of diffuse large B-cell lymphoma: rituximab, cyclophosphamide, etoposide and prednisone. The doses of vorinostat will be increased or decreased depending on the side effects that occur in each of the first few patients in the trial to find the safest dose with the least side effects. This is termed the phase I part of the clinical trial. Once the best dose of vorinostat is found, the rest of the patients in the clinical trial will be treated with this dose. This is termed the phase II part of the trial. The object of the trial is to find out what effects, good and/or bad, the combination of vorinostat, rituximab, cyclophosphamide, etoposide and prednisone will have on you and your lymphoma. #Intervention - DRUG : rituximab, cyclophosphamide, etoposide, prednisone, vorinostat and QOL questionnaire, peg-filgrastim or filgrastim - Patients will be treated with 6 cycles of rituximab, cyclophosphamide, etoposide, prednisone and vorinostat every 4 weeks. Quality of life determinations will be obtained at the beginning of each cycle of chemotherapy and at each visit during the first year of followup.

#Eligibility Criteria: Inclusion Criteria: * MSKCC or Weill Cornell biopsy confirmation of relapsed/refractory diffuse large B-cell lymphoma.Patients with large cell transformation of a low-grade B-cell lymphoma will be eligible. * One or two prior chemotherapy regimens not including autologous stem cell transplantation. * Age >= 60 years. * Not a candidate for autologous stem cell transplantation. * Patient must have performance status of <=2 on the ECOG Performance Scale. * Measurable disease * Adequate organ and bone marrow function: ANC >= 1000/mm3, platelet count >= 50,000/mm3, total bilirubin <= 1.5 ULN (with exception of Gilbert's disease), AST/ALT <= 2.5 ULN, creatinine <= 1.5 mg/dL or creatinine clearance >= 50 ml/min, potassium and magnesium within normal limits. * Male patients agree to use an adequate method of contraception for the duration of the study. * Patient is available for periodic blood sampling, study related assessments, and management at the treating institution for the duration of the study. Exclusion Criteria: * Patient who has had chemotherapy, radiotherapy, or biological therapy [including growth factors], within 30 days (42 days for nitrosoureas or mitomycin C) prior to initial dosing with study drug(s) or who has not recovered from adverse events due to agents administered more than 30 days earlier. Patients on a stable dose of steroids for at least 4 weeks prior to onset of study therapy may be included. * Patient is currently participating or has participated in a study with an investigational compound or device within 30 days of initial dosing with study drug(s). * Patient had prior treatment with an HDAC inhibitor (e.g., romidespin (Depsipeptide),NSC-630176, MS 275, LAQ-824, belinostat (PXD-101), LBH589, MGCD0103,CRA024781, etc). Patients who have received compounds with HDAC inhibitor-like activity, such as valproic acid, as anti-tumor therapy should not enroll in this study. Patients who have received such compounds for other indications, e.g. valproic acid for epilepsy, may enroll after a 30-day washout period. * Patients with active CNS lymphoma and/or lymphomatous meningitis are excluded. However, patients with a history of CNS lymphoma and/or lymphomatous meningitis who have been stable without evidence of CNS and/or leptomeningeal recurrence would be eligible. They must be off steroids or on a stable dose of steroids. * Patient with a primary central nervous system lymphoma. * Patient has known hypersensitivity to the components of study drug or its analogs. * Patient has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * Patient is, at the time of signing informed consent, a regular user (including 'recreational use') of any illicit drugs, substance abuse or had a recent history (within the last year) of drug or alcohol abuse. * Patient is expecting to father children within the projected duration of the study. * Patient has uncontrolled intercurrent illness or circumstances that could limit compliance with the study, including, but not limited to the following: active infection, acute or chronic graft versus host disease, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric conditions. * Patient has a history or current evidence of any condition, therapy, or lab abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study or is not in the best interest of the patient to participate. * Patient has a history of a gastrointestinal surgery or other procedures that might, in the opinion of the investigator, interfere with the absorption or swallowing of the study drugs. * Patient with a 'currently active' second malignancy, other than non-melanoma skin cancer and carcinoma in situ of the cervix, should not be enrolled. Patients are not considered to have a 'currently active' malignancy if they have completed therapy for a prior malignancy, are disease free from prior malignancies for >5 years or are considered by their physician to be at less than 30% risk of relapse. * Patient is HIV +. * Patient has active hepatitis B or C. ##Sex : ALL ##Ages : - Minimum Age : 60 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00058617", "Brief_Title" : "Epstein Barr Virus (EBV) Specific Cytotoxic T-Cells, Relapsed Lymphoma, ANGEL", "Official_title" : "Administration of Neomycin Resistance Gene Marked EBV Specific Cytotoxic T-Lymphocytes to Patients With Relapsed EBV-Positive Lymphoma", "Conditions" : ["Epstein-Barr Virus-Related Hodgkin Lymphoma", "Epstein-Barr Virus-Related Non-Hodgkin Lymphoma", "EBV Positive Plasma Cell Neoplasm"], "Interventions" : ["Biological: Injection of EBV Specific CTLs"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Patients have a type of lymph gland cancer called Hodgkin or non-Hodgkin Lymphoma which has come back or not gone away after treatment, including the best treatment known for relapsed Lymphoma. Patients are being asked to volunteer to be in a research study using Epstein Barr virus specific cytotoxic T lymphocytes, a new experimental therapy. This therapy has never been used in patients with Hodgkin disease or this type of non-Hodgkin Lymphoma but it has been used successfully in children with other types of blood cancer caused by EBV after bone marrow transplantation. Some patients with Hodgkin or non-Hodgkin Lymphoma show evidence of infection with the virus that causes infectious mononucleosis Epstein Barr virus before or at the time of their diagnosis of the Lymphoma. EBV is often found in the cancer cells suggesting that it may play a role in causing Lymphoma. The cancer cells infected by EBV are very clever because they are able to hide from the body's immune system and escape destruction. Investigators want to see if it's possible to grow special white blood cells, called T cells, that have been trained to kill EBV infected cells. Purpose The purpose of this study is to find the largest safe dose of EBV specific cytotoxic T cells, to learn what the side effects are and to see whether this therapy might help patients with Hodgkin disease and non-Hodgkin Lymphoma. Detailed Description The investigators will take 60-70 ml (12 teaspoonfuls) of blood from the patient to make a B cell line called a lymphoblastoid cell line or LCL by infecting the blood with a laboratory strain of EBV called B95-8. The investigators will then use this EBV infected cell line (which have been treated with radiation so that they cannot grow) as stimulator cells and mix it with more blood. This stimulation will train the T cells to kill EBV infected cells and result in the growth of an EBV specific T cell line. The investigators will then test the T cells to make sure that they kill the EBV infected cells and not normal cells and freeze them. Patients will be entered into one of three different dosing schedules being evaluated. Three to six patients will be evaluated on each dosing schedule. Escalation will continue until irreversible or life threatening side effects considered to be related to the T cells are seen. The cells will then be thawed and injected into the patients' vein over 10 minutes, after pretreatment with Tylenol and Benadryl. Tylenol and Benadryl are given to prevent a possible allergic reaction to the T cell administration. Initially, two doses of T cells will be given two weeks apart. If after the second infusion there is a reduction in the size of the patient's lymphoma on CT or MRI scan as assessed by a radiologist, the patient can receive up to six additional doses of the T cells. All of the treatments will be given at Texas Children's Hospital or the Methodist Hospital. Patients will be followed in the clinic after the injections. To learn more about the way the T cells are working and how long they last in the body, an extra 40 mls (8 teaspoonfuls) of blood will be taken before each infusion and then 24 hours after each infusion, 3-4 days after each infusion and at 1, 2, 4, and 6 weeks post infusion and then at 3, 6, 9 and 12 months post infusion. The blood may be drawn from the central line at the time of regular blood tests. This blood will be used to test for the frequency and activity of EBV specific T cells. A total of at least 122 teaspoons (approximately 40 tablespoons) of blood will be collected during participation in this study. If the patient decide to withdraw at any time during the study both samples and data collected during participation will be maintained. #Intervention - BIOLOGICAL : Injection of EBV Specific CTLs - Each patient will receive two injections, 14 days apart, according to the following dosing schedules: Group One Day 0 2x10\^7 cells/m2 Day 14 2x10\^7 cells/m2 Group Two Day 0 2x10\^7 cells/m2 Day 14 1x10\^8 cells/m2 Group Three Day 0 1x10\^8 cells/m2 Day 14 2x 10\^8 cells/m2 If patients with active disease have stable disease or a partial response by the RECIST criteria at their 8 week or subsequent evaluations they are eligible to receive up to 6 additional doses of CTLs at monthly intervals-each of which will consist of the same cell number as their second injection. Patients will not be able to receive additional doses until the initial safety profile is completed at 6 weeks following the second infusion.

#Eligibility Criteria: INCLUSION CRITERIA: * Any patient with EBV positive Hodgkin disease or non-Hodgkin Lymphoma, or plasma cell neoplasms in second relapse regardless of age or sex, in first relapse or with primary disease or in first remission if immunosuppressive chemotherapy contraindicated, e.g. patients who develop Hodgkin disease after solid organ transplantation or if the Lymphoma is a second malignancy e.g. a Richters transformation of CLL. * Life expectancy of greater than 6 weeks. * No severe intercurrent infection * Patient, parent/guardian able to give informed consent * Bilirubin <2x normal, * SGOT <3x normal, * Hgb greater than 8.0 g/L * Creatinine <2x normal for age * Must have been off other investigational therapy for one month prior to entry in this study. * Karnofsky score of greater than or equal to 50. EXCLUSION CRITERIA: * Patient with an EBV positive NHL secondary to an acquired immunodeficiency. * Patients who are HIV positive * Patient, parent/guardian unable to give informed consent * Patients with a Karnofsky score of < 50. * Patients with a life expectancy of <6 weeks * Patients with a bilirubin greater than 2x normal. SGOT greater than 3x normal * Patients with a creatinine greater than 2x normal for age * Due to unknown effects of this therapy on a fetus, pregnant women are excluded from this research. The male partner should use a condom. Note: Patients who would be excluded from the protocol strictly for laboratory abnormalities can be included at the investigator's discretion after approval by the CCGT Protocol Review Committee and the FDA reviewer. ##Sex : ALL ##Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01298011", "Brief_Title" : "Study of Gemcitabine and Abraxane to Treat Potentially Operable Pancreatic Cancer", "Official_title" : "A Pilot Phase II Multi Center Study of Gemcitabine and Nab-paclitaxel (Abraxane) as Preoperative Therapy for Potentially Operable Pancreatic Cancer", "Conditions" : ["Resectable Pancreatic Cancer"], "Interventions" : ["Drug: Gemcitabine and Abraxane"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The main purpose of this research study is to evaluate whether Abraxane and gemcitabine are effective in treating patients with operable pancreatic cancer. Detailed Description The best outcome for a patient diagnosed with pancreatic cancer is surgery. However many patients have recurrence of the cancer after successful surgery. The investigators are evaluating chemotherapy before surgery, which is a new approach. In this study, Abraxane and gemcitabine will be tested as treatment for people with operable pancreatic cancer to see if surgery can be successfully performed and if treatment will reduce cancer cells in the tumor at surgery. Abraxane is approved by the US FDA for the treatment of metastatic breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Gemcitabine is approved by the FDA for first line treatment for patients with locally advanced or metastatic cancer of the pancreas. #Intervention - DRUG : Gemcitabine and Abraxane - 3 treatments for gemcitabine and abraxane every 28-days for 3 months, prior to surgery. - Other Names : - nab-paclitaxel, gemzar

#Eligibility Criteria: Inclusion Criteria: * Patient has histologically or cytologically confirmed potentially resectable adenocarcinoma of the pancreas. Patients with islet cell neoplasms are excluded. Definition of potentially operable disease 1. Staging by high-quality, pancreatic protocol, helical abdominal computed tomography required (Endoscopic ultrasound is not required). 2. No extension to superior mesenteric artery (SMA) and hepatic artery. 3. Clear fat plane between the SMA and celiac axis. 4. No extension to celiac axis and hepatic artery. 5. Patent superior mesenteric vein and portal vein. 6. No evidence of distant or extra-hepatic disease by CT scans. 7. Pretreatment histological or cytological confirmation of an adenocarcinoma. * Male or non-pregnant and non-lactating female, and >= 18 years. * If a female patient is of child-bearing potential, she must have a negative serum pregnancy test (β hCG) documented within 72 hours of the first administration of study drug. * If sexually active, the patient must agree to use contraception considered adequate and appropriate by the Investigator. * Patient must have received no prior chemotherapy or radiation for pancreatic cancer and no exposure to gemcitabine and/or Abraxane * Patient has the following blood counts at baseline: 1. ANC >= 1.5 x 109/L (1500 /mm³); 2. Platelets >= 100 x 109/L; (100,000/mm³); 3. Hgb >= 10 g/dL. * Patient has the following blood chemistry levels at baseline: 1. AST (SGOT), ALT (SGPT) <= 2.5 x upper limit of normal (ULN); 2. Alkaline phosphatase (AP) <= 2.5 X ULN; 3. Total bilirubin <=1.5 mg/dl; 4. Serum creatinine <=1.5mg/dl or calculated clearance >= 50 mL/min/1.73 m² for patients with serum creatinine levels >1.5 mg/dl. * Patient has acceptable coagulation status as indicated by a PT within normal limits (±15%) and PTT within normal limits (± 15%). * Patient has an ECOG performance status PS 0 <= age <= 1. * Patient has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent Form prior to participation in any study-related activities. Exclusion Criteria: * Patient has borderline resectable disease * Patient uses therapeutic coumadin for a history of pulmonary emboli or DVT. * Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy. * Patient has known infection with HIV, hepatitis B, or hepatitis C. * Patient has undergone major surgery, other than diagnostic surgery (i.e.--surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day 1 of treatment in this study. * Prior chemotherapy or radiation for pancreatic cancer. Prior exposure to gemcitabine and/or Abraxane. * Patient has a history of allergy or hypersensitivity to the study drugs. * Patient has serious medical risk factors involving any of the major organ systems such that the Investigator considers it unsafe for the patient to receive an experimental research drug. * Patient is unwilling or unable to comply with study procedures. * Patient is enrolled in any other therapeutic clinical protocol or investigational trial. * Patient has metastatic disease on radiological staging. * Patients aged >= 80 are not excluded. As two events of fatal sepsis have been seen in this group in other studies, candidates in this age group should be thoroughly evaluated before enrollment in the study, to ensure they are fit to receive chemotherapy. In addition to meeting all of the baseline patient selection criteria, clinical judgment on their susceptibility to infection and expected stability of their performance status as to receive repeat weekly chemotherapy cycles, should be paid special attention to. Patients should not be enrolled in the study should there be any hesitation on any of these considerations. Baseline criteria for all patients enrolled on the study must be carefully evaluated and all criteria followed appropriately. ##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

{ "NCT_ID" : "NCT03350152", "Brief_Title" : "Treatment With Low-Dose Cytarabine in Elderly Patients (Age 70 Years or Older) With Acute Myeloid Leukemia: A Single Institution Experience.", "Official_title" : "Treatment With Low-Dose Cytarabine in Elderly Patients (Age 70 Years or Older) With Acute Myeloid Leukemia: A Single Institution Experience.", "Conditions" : ["Acute Myeloid Leukemia"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary The treatment of very elderly patients (≥70 years) with acute myeloid leukemia remains controversial. Although the outcome in younger adults has improved because of cytarabine- and anthracycline-based chemotherapy with advanced supportive care and introduction of hematopoietic stem cell transplantation, the benefit associated with standard intensive chemotherapy in older patients remain debatable. Life expectancy in elderly patients is a function of age, disability and comorbidity, performance score, along with leukemia characteristics such as genetic alterations or white blood cell count at diagnosis 'Older' patients are generally considered those aged 60 years or older. Intensive chemotherapy delivered to the very elderly with AML (patients _70 years of age), may not be beneficial to most and could be harmful to some. However, these patients are often referred to as 'unfit' or ineligible for intensive remission induction therapy. In daily practice, the final decision to treat intensively or not is made by the treating hematologist on a case by case basis according to patient's age, cytogenetics, performance score, concomitant diseases and type of AML (de novo or secondary). In older patients considered 'unfit' for intensive treatment, LD-AraC has been demonstrated to be more beneficial than best supportive care and hydroxyurea. The recent availability of new drugs that may have an improved side effect profile and in some cases bioavailability may offer future improvement for this patient population. The efficacy of hypomethylating agents has been studied in older AML patients with conflicting results. Recent publications refined prognostic information, which not only optimize existing treatments but also could lead to the development of additional targeted therapeutic approaches. In this study, the investigators focus on patients with AML (_20% blasts) aged 70 or older seen in our institution over a 14-year period. The objectives of the analysis are to describe the demographic, clinical and biological characteristics of this population and to evaluate how these characteristics and the treatment chosen affect

#Eligibility Criteria: Inclusion Criteria: * Have a diagnosis of AML according to World Health Organization (WHO) classification * Are at least 70 years Exclusion Criteria: * Patients with M3 AML of FAB classification (APL, Acute Promyelocytic Leukemia)##Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00538863", "Brief_Title" : "Long-term Safety and Efficacy Study of Fentanyl Sublingual Spray for the Treatment of Breakthrough Cancer Pain", "Official_title" : "Open-label Multi-center Safety Trial of Fentanyl Sublingual Spray (Fentanyl SL Spray) for the Treatment of Breakthrough Cancer Pain", "Conditions" : ["Cancer", "Pain"], "Interventions" : ["Drug: Fentanyl sublingual spray"], "Location_Countries" : ["United States", "India", "Canada"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study was to assess the 90-day safety of fentanyl sublingual spray for the treatment of breakthrough cancer pain in subjects on around-the-clock opioids for their persistent cancer pain. Detailed Description This was an open-label multi-center study of the safety of fentanyl sublingual spray as a treatment for breakthrough cancer pain. The study medication was administered under the tongue as a simple spray and could be self-administered by patients or assisted by their caregivers. In addition to safety, there was a questionnaire to assess satisfaction with the study medication. Subjects could enter this study by 1 of 2 routes: * De novo subjects who meet the inclusion criteria and none of the exclusion criteria at the Screening Visit were enrolled into the Open-label Titration Period of the study. Upon successful completion of the titration period, patients entered the Open-label Maintenance Period. * All patients who successfully completed the Double-blind Randomization Period and the Final Visit of study INS-05-001 (NCT00538850) were eligible to enter the Open-label Maintenance Period of this study. #Intervention - DRUG : Fentanyl sublingual spray - Fentanyl sublingual spray in doses of 100, 200, 400, 600, 800, 1200, and 1600 µg

#Eligibility Criteria: Inclusion Criteria: All subjects who have completed the Double-blind Period and Final Visit of protocol INS-05 <= age <= 001(NCT00538850), Multicenter Randomized Double-blind Trial of Fentanyl Sublingual Spray for the Treatment of Breakthrough Cancer Pain are eligible for participation in this open-label extension study. All de novo subjects must meet all of the following criteria to be eligible for participation in the study: * Male or female, > 18 years. * Diagnosis of cancer. * Opioid treatment. Patients who are treated with opioids are defined as those patients who are taking at least 60 mg of oral morphine/day, at least 25 µg of transdermal fentanyl/hour, at least 30 mg of oxycodone/day, at least 8 mg of oral hydromorphone/day or an equianalgesic dose of another opioid for > 7 days for cancer-related pain. * Experience persistent pain related to the cancer or its treatment of moderate or lesser intensity in the 24 hours prior to assessment by a verbal rating scale at the Screening Visit. * Experience on average 1 to 4 breakthrough cancer pain episodes per day usually at least partially controlled by supplemental medication of at least 5 mg immediate-release morphine or an equivalent short-acting opioid (eg, oxycodone, hydrocodone, or codeine with acetaminophen). * Able to evaluate pain relief, assess medication performance, report adverse events (AEs), report use of the study drug or supplemental medication (a caregiver may provide the subject the medication). * Able and willing to give informed consent. * Women of childbearing potential must have a) a negative urine pregnancy test, b) not be breast feeding and c) agree to practice a reliable form of contraception. Exclusion Criteria: * Intolerable side effects to opioids or fentanyl. * Rapidly increasing/uncontrolled pain. * A history of major organ system impairment or disease, that in the Investigator's or his/her designee's opinion could increase the risk associated with the use of opioids. * Uncontrolled hypertension (systolic blood pressure [BP] > 180 mm Hg or diastolic BP > 90 mm Hg on 2 occasions at least 6 hours apart) despite antihypertensive therapy, or has a history of hypertensive crisis within the past 2 years. * A recent history (within the past 2 years) of transient ischemic attacks, neural vascular disease, stroke, or cerebral aneurysms. * Serum creatinine, ALT or AST that is greater than 3 times the upper limit of normal. * Diagnosis of sleep apnea. * Brain metastases with signs or symptoms of increased intracranial pressure. * Inability to assess pain or response to pain medications for any reason, including psychiatric disorder, concurrent medical disorder, or concomitant therapy. * Has used methadone within 14 days of the Screening Visit. * Received an investigational study product(s) within 30 days of the Screening Visit. * Use of monoamine oxidase (MAO) inhibitors within 14 days of the Screening Visit. ##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

{ "NCT_ID" : "NCT01126060", "Brief_Title" : "Efficacy of Fibrin Sealant to Reduce the Amount of Post-thyroidectomy Drain", "Official_title" : "Efficacy of Fibrin Sealant to Reduce the Amount of Postoperative Drain in Patients With Harmonic Scalpel-assisted Total Thyroidectomy With Anterior Compartment Neck Dissections", "Conditions" : ["Thyroid Carcinoma", "Thyroidectomy"], "Interventions" : ["Drug: Usage of Fibrin sealant", "Procedure: Thyroidectomy"], "Location_Countries" : ["Korea, Republic of"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "QUADRUPLE" } }

#Study Description Brief Summary Fibrin sealant has been studied to reduce post-thyroidectomy drain and hospital stay as well. However, no strong evidence from well-designed clinical trials is available. Harmonic scalpel is a ultrasonic vibrating scissors which makes it easy to cut and coagulate the tissues, thus reducing op time and postoperative drain, which is important to minimize hospital stay. The investigators hypothesized that fibrin sealant combined with harmonic scalpel-assisted procedure could guarantee no-drain postoperative care in total thyroidectomy with anterior compartment neck dissection. #Intervention - DRUG : Usage of Fibrin sealant - Usage of 1 vial of fibrin sealant after hemostasis in total thyroidectomy with anterior compartment neck dissection - PROCEDURE : Thyroidectomy - surgical removal of bilateral thyroid glands

#Eligibility Criteria: Inclusion Criteria: * proven thyroid carcinoma * Thyroidectomy with anterior compartment neck dissection Exclusion Criteria: * No use of harmonic scalpel during surgery * coagulation abnormality * refuse to participate ##Sex : ALL ##Ages : - Minimum Age : 20 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01580579", "Brief_Title" : "Predictors of Radiation Pneumonitis in Locally Advanced Lung Cancer Treated With Chemoradiation", "Official_title" : "Clinical, Biochemical, Dosimetric and Functional Respiratory Predictors of Radiation Pneumonitis in Locally Advanced Lung Cancer (Stages IIIa and IIIb) Treated With Chemotherapy and Radiotherapy", "Conditions" : ["Radiation; Adverse Effect, Pneumonitis"], "Location_Countries" : ["Mexico"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary Lung cancer \[LC\] is the leading cause of cancer death worldwide. The standard treatment of locally advanced lung cancer unresectable or marginally resectable is combination therapy with radical or preoperative chemoradiation. The local control rates and survival with this treatment modality have increased by more than 30%. Radiotherapy \[RT\] with technical molded 3D \[3D-CRT, Three-Dimensional Conformal Radiation Therapy\] or IMRT \[intensity-modulated radiation therapy\] has allowed that the total dose of radiation has increased which leads to a direct benefit on the results treatment. Between 17-30% of patients are susceptible to pneumonitis due to radiation \[NR\]. This complication may appear at the end of the RT or up to 6 months after the treatment. In severe cases, mortality can reach 50%. It's well known that in various diseases, functional abnormalities precede the clinical manifestations. The degree of pulmonary failure secondary to RT is measured following the standards of the Radiation Therapy Oncology Group who ranks in degrees \[0 to 4\]. Not precisely known factors that influence the development of NR. Detailed Description Objectives: To evaluate the effect of chemotherapy and thoracic radiotherapy on pulmonary function and identify predictors of radiation pneumonitis in locally advanced lung cancer \[stages IIIA and IIIB\]. Hypothesis: Respiratory function tests may predict the development of radiation pneumonitis in patients with locally advanced lung cancer who receive radical treatment with chemoradiation. Methods Prospective cohort study with patients with locally advanced lung cancer of the Lung Cancer Clinic of the National Cancer Institute \[INCAN\]. Patients will receive weekly paclitaxel 50 mg and carboplatin AUC 2 with concomitant radiotherapy 44-63 Gy (22-33 fractions). Followup of lung function tests at baseline, during treatment with radiotherapy and will be carried out on 4 more occasions.

#Eligibility Criteria: Inclusion Criteria: * Candidates must have understood and signed informed consent * Histopathological diagnosis of locally advanced lung cancer [IIIA-cT2N1 <= age <= 2, cT3N1 <= age <= 2, cT4N0, M0o IIIB: cT2N3, cT3N3, cT4N1 <= age <= 3, M0]. They may also include patients with oligometastatic disease[M1] candidates for chemoradiation * Any histology * Medical tests: white blood cell count >= plasma 3,000 / mm3, platelets >= 100,000 / mm 3, hemoglobin >= 12 g / dl, serum creatinine <= 1.5 mg / dl, total bilirubin <= 1.5, transaminases [ <= 2.5 times the upper limit of normal [ULN], alkaline phosphatase <5 ULN. * Age >= 18 years. * General condition score according to ECOG 0 to 2 or a >= 60% Karnofsky. * Estimated life expectancy with treatment of at least 24 weeks. Exclusion criteria: * Uncontrolled concurrent diseases. * History of previous radiotherapy to the primary site. * Pregnant or breast-feeding. * Use of anticoagulants in therapeutic doses * Intercurrent Malignancies, except dormant basal cell carcinoma in skin, carcinoma in situ of the cervix * Invasive cancer unless the background was at least 5 years and the disease-free status. ##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

{ "NCT_ID" : "NCT01733004", "Brief_Title" : "A Phase 1 Study of MM-141 in Patients With Advanced Solid Tumors", "Official_title" : "A Phase 1 Study of MM-141 in Patients With Advanced Solid Tumors", "Conditions" : ["Hepatocellular Carcinoma"], "Interventions" : ["Drug: MM-141"], "Location_Countries" : ["United States", "France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This study is a Phase 1 and pharmacologic open-labeled dose-escalation trial using a '3+3' design, evaluating MM-141 at varying dose levels and frequencies. #Intervention - DRUG : MM-141

#Eligibility Criteria: Inclusion Criteria: * Advanced malignant solid tumors for which no curative therapy exists that has recurred or pgrogressed following standard therapy * Eighteen years of age or above * Able to understand and sign an informed consent (or have a legal representative who is able to do so) * Measurable disease according to RECIST v1.1 * ECOG Performance Score of 0 or 1 * Adequate bone marrow, hepatic, renal and cardiac function * Willing to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of MM-141 Exclusion Criteria: * Active infection or fever > 38.5°C during screening visits or on the first scheduled day of dosing * Symptomatic CNS disease * Received other recent antitumor therapy * Pregnant or breast feeding ##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

{ "NCT_ID" : "NCT00737893", "Brief_Title" : "Erythropoietin to Enhance Recovery of Erectile Function in Men Following Radical Prostatectomy", "Official_title" : "Erythropoietin to Enhance Recovery of Erectile Function in Men Following Radical Prostatectomy: a Prospective Randomized Controlled Trial (ERECT)", "Conditions" : ["Prostate Cancer", "Erectile Dysfunction"], "Interventions" : ["Drug: Placebo", "Drug: Erythropoietin (EPO)"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "TRIPLE" } }

#Study Description Brief Summary This research study aims to explore the effectiveness of human erythropoietin versus placebo in promoting the recovery of erectile function in patients undergoing bilateral nerve-sparing radical retropubic prostatectomy for clinically localized prostate cancer. Pre-clinical studies have shown erythropoietin potently promoted recovery of erectile function in rats and humans have similar receptors on penile tissues and the periprostatic neurovascular bundles. A clinical non-randomized study conducted in men undergoing radical prostatectomy demonstrated a benefit to recovery of erectile function. Therefore, the hypothesis is that erythropoietin offers nerve protection in men undergoing nerve-sparing radical prostatectomy and results in a reduced degree of erectile dysfunction and also an improved rate of erection recovery following surgery. Detailed Description This study will evaluate the effectiveness of erythropoietin versus placebo in the recovery of erectile function in patients undergoing bilateral nerve-sparing radical prostatectomy for prostate cancer. Recent laboratory findings in rat models and on human urogenital tissues suggest that erythropoietin may play a role in protection of the cavernous nerves during surgery. Some degree of nerve trauma occurs during bilateral nerve-sparing radical prostatectomy, but for most it is temporary. Erythropoietin will be studied as an investigational drug for enhancement of erectile function postoperatively in a prospective, randomized study. Erythropoietin has been used in many men undergoing open radical prostatectomy in the past according to FDA indications for preparation for noncardiac, nonvascular surgery with a high risk of blood loss. Evidence also suggests it is safe with no demonstration of increased risk of venous thromboembolism (blood clots) or cardiac events for men with prostate cancer undergoing radical prostatectomy. The length of the study is 12 months and involves receiving a dose of study drug or placebo on the day before surgery, the day of surgery, and the day following surgery. The dose is given by subcutaneous injection. The study will also require the completion of questionnaires which will be completed online every three months until study completion (at 3, 6, 9, and 12 months) to assess outcomes. #Intervention - DRUG : Placebo - Saline injection (solution prepared by research pharmacy) subcutaneously given the day before surgery, day of surgery, and the day after surgery. - DRUG : Erythropoietin (EPO) - Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.

#Eligibility Criteria: Inclusion Criteria: * Patient eligibility consists of men 40 <= age <= 65 of age * Localized prostate cancer * clinical stage T2a or lower * Gleason grade of 3+4 or 3+3 * prostate specific antigen (PSA) < 10 * Scheduled to undergo curative prostatectomy applying bilateral nerve-sparing procedure, with intact pre-surgical erectile function * International Index of Erectile Function-5 (IIEF-5) score of 22 <= age <= 25. * The patient has a sexual partner, of at least 6 months. * The patient's pre-surgical hematocrit is <= 48. * The patient is willing to attempt intercourse at least 5 times per month following recovery from surgery. Exclusion Criteria: * The patient has known penile deformity or a history of Peyronie's disease. * The patient has planned pre or post operative androgen therapy. * The patient has planned pre or post operative radiation therapy. * The patient is on anticoagulation therapy. * The patient has a history of sickle cell anemia. * The patient has a history of high or low blood pressure that is not controlled. * The patient is taking medications called 'nitrates' * The patient has a history of heart problems such as angina, heart failure, irregular heartbeats, or myocardial infarction * The patient has a history of history of drug or alcohol abuse. * The patient currently smokes or has a 20 pack/year history of cigarette smoking. * The patient has a history of acute or chronic depression * The patient has a history liver problems, or kidney problems. * The patient has a history of retinitis pigmentosa or severe vision loss, including a condition called NAION, Nonarteritic Anterior Ischemic Optic Neuropathy. * The patient has a history of spinal trauma or surgery to the brain or spinal cord. * The patient has contraindications to the use of phosphodiesterase type 5 (PDE 5) inhibitors. * Patient is currently participating in another clinical investigation that would serve as a contraindication to administering erythropoietin. ##Sex : MALE ##Ages : - Minimum Age : 40 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT05834270", "Brief_Title" : "Single Dose Versus Double Dose Tamsulosin in Management of Moderate and Severe LUTS Due to BPH", "Official_title" : "Single Dose Versus Double Dose Tamsulosin in Management of Moderate and Severe Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia", "Conditions" : ["Prostatic Neoplasms", "Prostate Disease", "Prostate Obstruction", "Prostate Hypertrophy"], "Interventions" : ["Drug: Double dose tamsulosin 0.4mg", "Drug: Single dose tamsulosin 0.4mg"], "Location_Countries" : ["Egypt"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "DOUBLE" } }

#Study Description Brief Summary Single dose versus double dose tamsulosin in Management of Moderate and severe lower urinary tract symptoms due to benign prostatic hyperplasia #Intervention - DRUG : Single dose tamsulosin 0.4mg - Single dose tamsulosin 0.4mg - DRUG : Double dose tamsulosin 0.4mg - Double dose tamsulosin 0.4mg

#Eligibility Criteria: Inclusion Criteria: * age more than 50 years * moderate to severe lower urinary tract symptoms Exclusion Criteria: * prostatic cancer * urethral stricture * prostate surgery * Neurogenic bladder ##Sex : MALE ##Ages : - Minimum Age : 50 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT06051838", "Brief_Title" : "Prognostic Value of Tumor Deposits for Patients With Papillary Thyroid Carcinoma", "Official_title" : "Prognostic Value of Tumor Deposits for Patients With Papillary Thyroid Carcinoma: a Retrospective Cohort Study", "Conditions" : ["Exploring the Prognostic Value of Tumor Deposits PTC Patients"], "Interventions" : ["Procedure: surgery"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary Tumor deposits (TD), nodules in the peritumoral adipose tissue with no architectural residue of lymph node, which is a definition often being confusing to the extranodal extension (ENE), have been described in several malignancies and linked to a worse prognosis. In gastric cancer and colon cancer, TD and ENE should be distinguished and collected separately in 8th AJCC manual. However, in thyroid cancer, TD as a collection variable was absence in both the 8th AJCC manual and the 2015 ATA guideline. This is a study that revealed the presence of TD by reviewing a large number of papillary thyroid carcinoma (PTC) specimens and explored its prognostic value by constructing a nomogram to accurately predict disease-free survival in PTC patients. #Intervention - PROCEDURE : surgery - if the patients is TD positive, we recommond careful surgery and pathological examination.

#Eligibility Criteria: Inclusion Criteria: (1) patients with histopathologically confirmed PTC and sections stored in the pathology department; (2) patients underwent lobectomy or total thyroidectomy and central lymph node dissection with or without lateral neck dissection; (3) patients cooperated to provide follow-up information after surgery. Exclusion Criteria: (1) patients with previous history of neck irradiation or other systematic cancers; (2) patients died of unrelated diseases. ##Sex : ALL ##Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02166554", "Brief_Title" : "The Efficacy and Safety Study of a New Cross-linked Hyaluronan Hydrogel in the Reduction of Postsurgical Peritoneal Adhesions", "Official_title" : "The Efficacy and Safety of a New Cross-linked Hyaluronan Hydrogel in the Reduction of Postsurgical Adhesions After Laparoscopic Gynecological Surgery: a Randomized Controlled Trial", "Conditions" : ["Myomas", "Ovary Cysts", "Endometriotic Cysts", "Adhesions"], "Interventions" : ["Other: Saline", "Device: Cross-linked Hyaluronan Hydrogel"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "DOUBLE" } }

#Study Description Brief Summary The purpose of this study was to determine whether the new crosslinked hyaluronan hydrogel was safe to use, and was effective for the prevention/reduction of adhesion formation following gynecological surgery Detailed Description Postsurgical adhesions are a common medical complication of gynecologic and pelvic surgeries, and are frequently associated with chronic or recurrent pelvic pain, intestinal obstruction and infertility. This randomized, controlled, multicenter, clinical study was designed to evaluate the safety and performance of the new crosslinked hyaluronan hydrogel versus the standard of care for the reduction of postoperative adhesions in subjects undergoing laparoscopic surgeries. Subjects were scheduled to return at 9 weeks after the initial surgical procedure. At that time, a second-look laparoscopy was performed for postsurgical adhesion assessment. Adhesions were graded using a modified American Fertility Society (mAFS) scoring system. #Intervention - OTHER : Saline - On the day of initial surgery - DEVICE : Cross-linked Hyaluronan Hydrogel - On the day of the initial surgery - Other Names : - HyaRegen, Self Cross-linked Hyaluronan Gel

#Eligibility Criteria: Inclusion Criteria: * Female. * Aged 18 <= age <= 45 years. * Been scheduled for removal of myomas, ovary cysts, endometriotic cysts or adhesions. * Been willing to comply with all aspects of the treatment and evaluation schedule. * Agreed to a second-look laparoscopic procedure to assess and lyse any adhesions formed at 9 weeks following the primary surgery. * Provided voluntary written informed consent. Exclusion Criteria: * Acute or severe infection. * Autoimmune diseases such as diabetes etc. * Abnormal liver/renal and cardiovascular function * Abnormal blood coagulation * Medical histories of peripheral vascular disease, alcohol or drug abuse, and mental illness. * Known or suspected intolerance or hypersensitivity to hyaluronan or its derivatives. * Concurrent use of systemic antiinflammatory drugs. * Clinical evidence of cancer. * Use of anticoagulant, fibrin glue, other thrombogenic agents, or any other anti-adhesion agent during the procedure. * Concurrent peritoneal grafting or tubal implantation. ##Sex : FEMALE ##Ages : - Minimum Age : 18 Years - Maximum Age : 45 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03625505", "Brief_Title" : "A Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Participants With Relapsed/Refractory Acute Myeloid Leukemia", "Official_title" : "A Multicenter, Open-Label Phase 1b Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Subjects With Relapsed/Refractory Acute Myeloid Leukemia", "Conditions" : ["Acute Myeloid Leukemia (AML)"], "Interventions" : ["Drug: Gilteritinib", "Drug: Venetoclax"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SEQUENTIAL", "Masking" : "NONE" } }

#Study Description Brief Summary A dose-escalation study evaluating the safety, tolerability, pharmacokinetics (PK) and efficacy of venetoclax, in combination with gilteritinib, in participants with relapsed or refractory (R/R) acute myeloid leukemia (AML) who have failed to respond to, and/or have relapsed or progressed after at least 1 prior therapy. #Intervention - DRUG : Venetoclax - tablet, oral - Other Names : - ABT-199, GDC-0199 - DRUG : Gilteritinib - tablet, oral - Other Names : - ASP-2215

#Eligibility Criteria: Inclusion Criteria: * Should have an established, confirmed diagnosis of Acute Myeloid Leukemia (AML) by World Health Organization (2016). * Should have failed at least 1 line of prior therapy (defined as failure to respond to therapy, and/or progression during or after therapy). * Should have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. * Should have adequate hematologic, kidney and liver function as described in the protocol. * For participants enrolling into the Expansion Cohort only: a documented FMS-like Tyrosine Kinase (FLT3) mutation in bone marrow or peripheral blood, as described in the protocol. Exclusion Criteria: * Has a diagnosis of acute promyelocytic leukemia (APL) or BCR-ABL-positive leukemia. * Has a history of other malignancies within 2 years prior to study entry, with exceptions as described in the protocol. * Has active central nervous system leukemia. * Has a history of chronic New York Heart Association (NYHA) class IV heart failure. * Has a corrected QT interval of > 450 ms. * Has a chronic respiratory disease that requires continuous oxygen use. ##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

{ "NCT_ID" : "NCT01753544", "Brief_Title" : "Endoscopic Submucosal Dissection Using a Thulium Laser", "Official_title" : "Endoscopic Submucosal Dissection Using a Thulium Laser: Preliminary Results of a New Method for Treatment of Gastric Epithelial Neoplasia", "Conditions" : ["Gastric Dysplasia"], "Location_Countries" : ["Korea, Republic of"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary We aim to evaluate safety and feasibility of a thulium laser system in performing endoscopic submucosal dissection of gastric neoplasia. Detailed Description Instead of endoscopic knives, a thin, flexible fiber is inserted through the working channel of the endoscope. Acetic acid (1.5%) and indigo carmine dye are sprayed onto the lesion to clarify the margin. Markings are made 10 mm outside the tumor margin using a laser fiber with a power setting at 30 W. After marking, a mixture of sodium hyaluronate with indigo carmine and epinephrine (1:25000) is injected into the submucosa outside the marking dots. A circumferential mucosal incision and submucosal dissection are performed by a thulium laser fiber with a power setting at 30 to 40 W. Activation of the laser beam is controlled by stepping on a foot pedal. Hemostasis during procedure is also attempted using the thulium laser. When hemostasis is not achieved properly, additional use of hemostatic forceps or a hemoclip will be considered.

#Eligibility Criteria: Inclusion Criteria: * biopsy-proven gastric epithelial neoplasia Exclusion Criteria: * a.differentiated adenocarcinoma, ulcer(+), more than 3cm b.differentiated adenocarcinoma, submucosal invasion(+), more than 3cm c.undifferentiated adenocarcinoma, more than 2cm ##Sex : ALL ##Ages : - Minimum Age : 20 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: Yes

{ "NCT_ID" : "NCT05631379", "Brief_Title" : "Influence of Nutritional Status on Oncologic and Operative Outcome in Patients Operated for Retroperitoneal Sarcoma", "Official_title" : "Influence of Body Composition, Nutritional Status and Inflammatory Markers on Survival and Postoperative Outcome in Patients Operated on for Primary Retroperitoneal Sarcoma: Report From Institute of Oncology Ljubljana", "Conditions" : ["Retroperitoneal Sarcoma", "Body Composition", "Malnutrition", "Sarcopenia", "Sarcopenic Obesity", "Myosteatosis"], "Interventions" : ["Diagnostic Test: EWGSOP2 sarcopenia criteria", "Diagnostic Test: GLIM malnutrition criteria", "Diagnostic Test: ESPEN-EASO criteria for sarcopenic obesity", "Diagnostic Test: Prognostic Nutritional Index (PNI)", "Other: Measurement of body composition with computed tomography (CT)", "Diagnostic Test: The high-sensitivity modified Glasgow prognostic score"], "Location_Countries" : ["Slovenia"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary This is a retrospective, observational study in consecutive patients operated on for primary RPS in the Institute of Oncology Ljubljana (Slovenia) between September 1999 and June 2020. This study aims to investigate the impact of preoperatively assessed body composition parameters on the perioperative outcomes of patients operated on for primary RPS. The impact of preoperative malnutrition, sarcopenia, sarcopenic obesity and myosteatosis to the oncologic and postoperative outcome in patients operated on for primary RPS will be examined. Additionally, the aim is to evaluate the prognostic role of preoperative immune and inflammatory markers (serum albumin level, C-reactive protein, neutrophil to lymphocyte ratio, platelet to lymphocyte ratio, high-sensitivity modified Glasgow prognostic score) and prognostic nutritional index in primary RPS patients undergoing surgery. Patient outcome will be evaluated in terms of overall survival (OS), local-recurrence free survival (LRFS), postoperative intrahospital length of stay, overall and major postoperative morbidity. Detailed Description Retroperitoneal sarcomas (RPS) are rare neoplasms of mesenchymal origin with estimated crude incidence of 0.3 cases per 100000 inhabitants per year. The most common histologic subtypes are well-differentiated and dedifferentiated liposarcoma and leiomyosarcoma, accounting for 42% and 26% of cases, respectively. RPS are optimally managed in multidisciplinary settings in specialized sarcoma centers. Surgical resection with an adequate margin of normal tissue is the cornerstone of curative therapy and en bloc surgical resection of localized tumors is the recommended surgical approach. This 'extended' surgical approach (including resection of adjacent organs), is optimal for reducing local recurrence and improving overall survival. Cancer patients undergoing surgical treatment face number of challenges which negatively impact their nutritional status. Patients are usually in catabolic state, which together with ongoing proteolysis and lipolysis as well as decreased protein synthesis contribute to development of cancer - associated cachexia. Most important nutritional disorders in these patients are malnutrition, sarcopenia, cancer cachexia. On the other side, often under-recognized, sarcopenic obesity is gaining attention in clinical and research settings. The association of malnutrition and poor postoperative outcome has been demonstrated in patients with various cancer locations. Malnourished patients reportedly have longer length of postoperative stay (LOS), higher rates of 30-day mortality, infection rate, sepsis, reoperation, increased number of cardiopulmonary complications. Diagnostic process of malnutrition has been a topic of debate considering inconsistency in diagnostic methodology and criteria. Global Leadership Initiative on Malnutrition (GLIM) addressed this problem and recommended a new diagnostic scheme for malnutrition, in form of consensus report incorporating previous finding and recommendations from world leading clinical nutrition societies. To our knowledge, no study validated GLIM criteria in patients with primary RPS. Sarcopenia is clinical syndrome characterized by generalized skeletal muscle mass loss, loss of strength and function (performance). Sarcopenia has been associated with lower survival rate and proved to be an independent predictor of survival in patients with breast cancer, pancreatic adenocarcinoma, hepatocellular carcinoma, and melanoma. There is a lack of studies investigating the impact of sarcopenia on survival and postoperative outcome in patients with soft-tissue sarcoma (STS), including retroperitoneal sarcoma. Similarly to malnutrition diagnosis, there is an evident inconsistency and confusion in diagnostic criteria and tools used to define and characterize sarcopenia in clinical practice and research. However, recently the European Working Group on Sarcopenia in Older People (EWGSOP2) published updated findings in form of Revised European Consensus. The Working Group proposed new recommendation, among which are those related to establishing specific cut-off points for body composition (primarily skeletal muscle quantity and quality) measures that identify and characterize sarcopenia. Sarcopenic obesity (SO) is co-existence of sarcopenia and excess adiposity. Recent expert consensus of The European Society for Clinical Nutrition and Metabolism (ESPEN) and the European Association for the Study of Obesity (EASO) will be followed for definition and diagnostic criteria for SO. Myosteatosis is ectopic adipose tissue infiltration in skeletal muscle. Intermuscular adipose tissue can be quantified using CT scans by low muscle radiodensity. CT-derived myosteatosis contributes to impaired glucose metabolism, including insulin resistance, type 2 diabetes mellitus, and inflammation. Additionally, it may increase the risk for dyslipidemia. Myosteatosis may predict oncologic and postoperative outcome in primary RPS patients. Patients with primary RPS are in a great risk for malnutrition, sarcopenia and cachexia for the number of reasons: requirement for demanding abdominal surgery in their management, catabolic tumor effects, long period before diagnosis of RPS and tumor size (approximately 15 cm). Due to their rarity, it is still unclear how preoperative nutritional status and body composition impact outcome of patients with primary RPS. STUDY DESIGN DATA COLLECTION Patient's histories including the anaesthetician's preoperative reports, surgeon's operative reports, hospital records, and follow-up data will be collected. Paper and electronic data archive of Institute of Oncology Ljubljana Patient Data Information System will be used. The following preoperative clinical data will be acquired: age, sex, preoperative weight, height, significant weight loss, appetite loss and weakness. CT reports will be also acquired for analysis as well as histopathological diagnosis (subtype), stage, grade and tumor size. The preoperative laboratory data, including absolute counts of leukocytes, neutrophils, lymphocytes, monocytes and platelets, CRP, and albumin levels will be assessed. Data will be deidentified and whenever possible all measures to conceal patient identifiers and maintain patient confidentiality will be taken. STATISTICAL CONSIDERATIONS The data will be presented using appropriate summary statistics: mean, median, standard deviation for continuous variables and percentages and frequencies for categorical variables. Kaplan-Meier method will be used for survival curves analysis and differences between survival rates compared using the log-rank test. The independent prognostic variables for survival (OS and LRFS) will be identified using Cox proportional hazard model (hazard ratio, 95% confidence interval, p value). ETHICS The study was approved by Slovenian National Medical Ethics Committee, Institute of Oncology Ljubljana Review Board and Institute of Oncology Ljubljana Ethical Committee. The need to obtain informed consent from participants was waived. #Intervention - OTHER : Measurement of body composition with computed tomography (CT) - The cross section of the third lumbar vertebrae in the CT scan images of the patients will be analyzed for assessment of body composition parameters including skeletal muscle area (SMA), muscle radiation attenuation (MRA), visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT) - DIAGNOSTIC_TEST : GLIM malnutrition criteria - GLIM criteria (Global Leadership Initiative on Malnutrition) will be applied to assess malnutrition - DIAGNOSTIC_TEST : EWGSOP2 sarcopenia criteria - EWGSOP2 criteria (Writing Group for the European Working Group on Sarcopenia in Older People 2) will be followed to determine the diagnosis of sarcopenia - DIAGNOSTIC_TEST : ESPEN-EASO criteria for sarcopenic obesity - The European Society for Clinical Nutrition and Metabolism (ESPEN) and the European Association for the Study of Obesity (EASO) consensus criteria from 2018 will be applied to assess sarcopenic obesity - DIAGNOSTIC_TEST : Prognostic Nutritional Index (PNI) - Prognostic Nutritional Index is diagnostic test based on serum albumin level and total lymphocyte count - DIAGNOSTIC_TEST : The high-sensitivity modified Glasgow prognostic score - The high-sensitivity modified Glasgow prognostic score (Hs-mGPS) is an inflammation-based score consisted of C-reactive protein level and serum albumin

#Eligibility Criteria: Inclusion Criteria: * Patients aged above 18 years * Patients with primary localized RPS or pelvic sarcoma operated at Surgical Department of Institute of Oncology in Ljubljana Exclusion Criteria: * Patients with Gastrointestinal Stromal Tumors (GISTs) and Retroperitoneal desmoid-type fibromatosis (DF) * Patients with visceral sarcomas (arising from visceral organ i.e., gastrointestinal, and genitourinary tracts sarcoma) * Patients with benign retroperitoneal / pelvic tumors * Patients with residual RPS operated at another hospital * Patients with present recurrent, secondary, and metastatic RPS * Unable to access patients' data ##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

{ "NCT_ID" : "NCT02278198", "Brief_Title" : "Evaluation of Thyroid Stunning From a Diagnostic Dose of I-123", "Official_title" : "Evaluation of Thyroid Stunning From a Diagnostic Dose of I-123", "Conditions" : ["Differentiated Thyroid Cancer"], "Interventions" : ["Drug: rhTSH"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of the study is to find out if the small dose of radioiodine, that is used for the dosimetry study on patients with differentiated thyroid cancer, may stun the cancer cells and make the thyroid cancer treatment less effective. Detailed Description This study plans to learn more about a medical problem called thyroid stunning. Thyroid stunning is a temporary decrease in the function of thyroid cells after small doses of radioiodine, a radioactive drug that is commonly used to treat thyroid cancer. Thyroid stunning can be an important medical problem in patients who have thyroid cancer that has spread beyond the thyroid gland (metastases). In patients with thyroid cancer metastases, some researchers believe it is good to give the maximum safe dose of radioiodine in order to have the greatest chance of destroying the cancer. The maximum safe dose is the highest dose of radioiodine that a patient can safely receive, and this dose is unique to each person. This special personalized dose is determined by first doing a dosimetry study. Dosimetry study is a planning study that calculates the safest dose that the patient can receive. Currently, it is not known whether the small dose of radioiodine that is used for the dosimetry study may stun the cancer cells and make the thyroid cancer treatment less effective. There are two important types of radioiodine. I-123 is a form of radioiodine that is used to take pictures of the thyroid gland. I-131 is a form of radioiodine that is used to treat thyroid cancer. It is hoped that this study will produce important information that may be the first step in resolving the thyroid stunning question. Investigators will use I-123, a form of iodine that is currently not known to cause thyroid stunning, before thyroid cancer treatment with I-131. Investigators will try to prove that I-123 does not cause thyroid stunning and does not make the thyroid cancer treatment less effective. Patients are being asked to be in this research study because they have differentiated thyroid cancer, and they have no evidence of thyroid cancer that has spread to the other parts of their body. As a result, those patients thyroid cancer treatment with radioiodine will be a smaller amount than what is needed to treat patients with thyroid cancer that has spread to other parts of the body. Thyroid stunning is not a medical problem for patients like these. However, by participating in this study, the information investigators gather from those patients treatment of thyroid cancer may help those patients with thyroid cancer metastases. #Intervention - DRUG : rhTSH - Intramuscular injections of rhTSH (Thyrogen) will be given on days 1 and 2. - Other Names : - Thyrogen

#Eligibility Criteria: Inclusion Criteria: * Patient must be 21-years-old or greater. * Patient must be status post near total thyroidectomy for differentiated thyroid cancer without known distant metastases and who are planning to undergo routine remnant thyroid tissue ablation with I-131. * Patients must qualify for thyroid ablation with I-131. Exclusion Criteria: * Women who are pregnant or breastfeeding. * Prior bovine TSH use. * Known metastatic thyroid cancer. * History of cardiovascular disease that may adversely affect patient participation at the discretion of the primary investigator. * Patients on hemodialysis. * Patients with acute serious illnesses at the discretion of the primary investigator. ##Sex : ALL ##Ages : - Minimum Age : 21 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT04314778", "Brief_Title" : "Using Patient Centered Data and Behavioral Economics to Improve Mobility and Reduce Readmissions After Major Abdominal Surgery", "Official_title" : "Using Patient Centered Data and Behavioral Economics to Improve Mobility and Reduce Readmissions After Major Abdominal Surgery for Cancer", "Conditions" : ["Bladder Cancer"], "Interventions" : ["Behavioral: social incentive-based gamification"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "OTHER", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This is a two-arm randomized, controlled trial during the postoperative period after major abdominal surgery for cancer, including for example radical cystectomy, nephrectomy, colectomy, comparing a control group that uses a wearable device to track physical activity to an intervention group that uses the same wearable devices and receives a supportive social incentive-based gamification intervention to adhere to a step goal program. #Intervention - BEHAVIORAL : social incentive-based gamification - At the beginning of each week, starting from postoperative day 3, the participant receives 70 points (10 points for each day that week). If the participant does not meet their daily step goal, they lose 10 points from their balance. This leverages loss aversion, which has been demonstrated to motivate behavior change more effectively with losses than gains. At the end of each week if the participant has at least 40 points, they will move up a level (levels from lowest to highest: blue, bronze, silver, gold, platinum). If not, the participant will drop a level. All participants begin at the silver level. Each week, participants get a fresh set of 70 points. Participants will receive daily feedback for the step counts, and weekly feedback for their levels. Participants in the intervention arm will be asked to identify a family member or friend to be their support sponsor. A weekly report will be sent to this person with the participant's performance (points and level).

#Eligibility Criteria: Inclusion Criteria: * Age >= 18 years * diagnosis of cancer undergoing definitive surgical treatment Exclusion Criteria: * Inability to provide consent * does not have daily access to a smartphone compatible with the wearable device and not willing to use a device that the investigators can provide them * any other medical conditions that would prohibit participation in a physical activity program ##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

{ "NCT_ID" : "NCT05551286", "Brief_Title" : "Feasibility of the YATAC Programme", "Official_title" : "The 'Young Adult Taking Action' Programme for Young Adult Cancer Survivors: a Feasibility Study Evaluating Content and Delivery", "Conditions" : ["Cancer"], "Interventions" : ["Other: A rehabilition programme for young adult cancer survivors"], "Location_Countries" : ["Denmark"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Young adult cancer survivors (YACS) aged 18-39 report physical and psychosocial late effects following cancer treatment, impairing quality of life and participation in everyday life. To address such multifactorial challenges complex or multicomponent rehabilitation interventions are needed. Based on this, the 'Young Adult Taking Action' (YATAC) programme was developed to increase participation in everyday life and improve health-related quality of life. The development of the intervention is guided by the British Medical Research Council's guidance (MRC) and the framework for the co-production and prototyping of public health interventions by Hawkins et al. The present study will investigate the acceptability and fidelity of the intervention at the research clinic of REHPA, the Danish Knowledge Centre for Rehabilitation and Palliative Care in Nyborg, Denmark. A mixed method one-armed feasibility study will be conducted and the results of the study will be used to revise version 1.0 of the programme. #Intervention - OTHER : A rehabilition programme for young adult cancer survivors - The programme consists of 22 sessions focusing on; 1) everyday life (energy conservation, cognitive challenges, fatigue); 2) Physical activity; 3) psychological issues; 4) work and study d; 5) sexuality and relationship; 7) rights and finance, and 8) goal setting. The sessions include both education, workshops, and engagement in different activities and will be delivered by a multidisciplinary team.

#Eligibility Criteria: Inclusion Criteria: * Being between 18 <= age <= 39 years at baseline * Have had any type of cancer * Have completed primary/active cancer directed treatment (cytotoxic chemotherapy, radiation therapy and/or definitive surgical intervention, while current hormonal treatments or maintenance therapies are permissible) * Determined a need for rehabilitation determined by the REHPA scale (a linear analogue scale, where the participants indicate how close they are to living the life they desire after ending cancer treatment). The scale ranges from 0= 'goal reached' to 9= 'infinitely far from' * Have access to a device with Internet options (i.e., smartphone or tablet) Exclusion Criteria: * Dependent in basic personal activities of daily living (personal care, dressing and eating) * No permanent residence in Denmark * Not able to speak and understand Danish ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Maximum Age : 39 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00609505", "Brief_Title" : "Telemedicine vs. Face-to-Face Cancer Genetic Counseling", "Official_title" : "Telemedicine vs. Face-to-Face Cancer Genetic Counseling in Rural Oncology Clinics", "Conditions" : ["Hereditary Breast and Ovarian Cancer Syndrome", "Lynch Syndrome"], "Interventions" : ["Other: Face-to-Face", "Other: Telemedicine"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "HEALTH_SERVICES_RESEARCH", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary Cancer genetic counseling (CGC) has been found to have 'substantial' benefits for individuals with breast cancer and their family members; it has been deemed by multiple organizations as 'standard of care' for women with breast cancer and their relatives. Unfortunately, there is a disparity in access to CGC, especially among women who live in rural and underserved areas. In North Carolina, only two cancer genetic counselors practice in rural clinics - each only for a few days per month. Therefore, in an effort to make CGC more widely available in a timely manner, we propose to test provision of counseling through telemedicine (TM), in which a patient and health care provider communicate with each other using videoconferencing. In 4 rural oncology clinics, we will implement low-cost TM and compare satisfaction and cost-effectiveness between groups of women designated to have their CGC session by TM or FTF. We'll use a validated measure to assess satisfaction by a phone survey one week after the CGC appointment; cost-effectiveness will be measured at project's end by calculating length of wait time for appointment and costs of equipment, labor, and mileage. Study hypothesis: TM is as satisfactory as FTF counseling and is a more cost-effective way to provide this beneficial service. #Intervention - OTHER : Telemedicine - Telemedicine genetic counseling - OTHER : Face-to-Face - Face-to-face genetic counseling

#Eligibility Criteria: Inclusion Criteria: * Individuals referred for cancer genetic counseling (e.g., by medical oncologist, primary care physician or self) in one of 4 oncology clinics: Gibson Cancer Center in Lumberton, NC; Scotland Cancer Treatment Center in Laurinburg, NC; Johnston Cancer Center in Smithfield, NC; and Maria Parham Cancer Center in Henderson, NC. * Willing to be randomized to receive counseling via telemedicine or face-to-face. Exclusion Criteria: * Referred for cancer genetic counseling from any clinic other than the 4 listed above. * Unwilling to be randomized to receive counseling via telemedicine or face-to-face. ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: Yes

{ "NCT_ID" : "NCT04515043", "Brief_Title" : "EXPLORATORY STUDY Addendum to INVAC1-CT-101 (NCT02301754)", "Official_title" : "AN EXPLORATORY FOLLOW-UP STUDY OF LONG TERM ANTI-TELOMERASE IMMUNE RESPONSE AFTER INVAC-1 VACCINATION IN PATIENTS WITH LONG TERM SURVIVAL. Addendum to INVAC1-CT-101 PROTOCOL - EUDRACT NUMBER : 2013-004369-15", "Conditions" : ["Solid Tumor, Adult"], "Interventions" : ["Drug: INVAC-1 given in the previous phase 1 NCT02301754. No new injection is required in this study."], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "OTHER", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This study will be an exploratory study of long term immunogenicity of INVAC-1 in patients who participated in the INVAC1-CT-101 phase I study (between 2014 and 2018). Detailed Description The primary goal of the study is to analyze anti-telomerase specific memory responses in blood of long term survival patients and to correlate these immune responses to their subsequent treatment since the end of INVAC1-CT-101 phase I study. Six patients are expected to participate in this study. #Intervention - DRUG : INVAC-1 given in the previous phase 1 NCT02301754. No new injection is required in this study. - blood sampling will be drawn once in order to analyse long term memory immune response to INVAC-1 vaccine - Other Names : - blood sampling

#Eligibility Criteria: Inclusion Criteria: * Patients who participated in the phase I study and are still alive at the present time * Ability to provide written informed consent and to understand and comply with the requirements of the study. Exclusion Criteria: * Anemia (Hgb < 7g/dL) according to L-1121 <= age <= 1 annexe 2 of Code de Santé Publique * Systolic blood pressure below 90 mm Hg ##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

{ "NCT_ID" : "NCT01411787", "Brief_Title" : "Bootcamp During Neoadjuvant Chemotherapy for Breast Cancer", "Official_title" : "Bootcamp During Neoadjuvant Chemotherapy for Breast Cancer 'Can we Kick Down Ki-67, Punch Out Insulin Resistance, and Increase Survival?'", "Conditions" : ["Breast Cancer"], "Interventions" : ["Behavioral: Exercise"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "SINGLE" } }

#Study Description Brief Summary This is a randomized, single-site pilot study incorporating one control group. This research involves an exercise group and a non-exercise group (control group). The patients who are in the exercise group will be enrolled in the Dallas County Women's Adventure Boot Camp. This will require them to undergo exercise training 3 times per week, under the direction of an experienced personal trainer in a group setting. All Boot Camp personal trainers are trained in basic cardiac life support (CPR) and are trained to watch for any signs or symptoms associated with a poor exercise response. The investigators hypothesize that randomizing women to a supervised exercise program of core conditioning, muscular/circuit training, and short distance running administered during neoadjuvant chemotherapy for breast cancer can be performed. Patients will continue on study as they are undergoing neoadjuvant chemotherapy for their breast cancer. This will be about 4 - 6 months. Detailed Description The exercise protocol will consist of activities including walking/running up to a mile, calisthenics (jumping jacks, short relays, rapid punches) and light (no greater than 5 pounds) weight lifting. The patients who do not receive the exercise program will be allowed to do what they would normally do during their neoadjuvant chemotherapy. They are allowed to engage in their own exercise regimens and diet modifications. Subjects will receive the chemotherapy as directed by their physicians, and then undergo surgery as planned. Randomization will occur by drawing cards entitled 'exercise' or 'control' from an envelope and then assigning the patient to this group. #Intervention - BEHAVIORAL : Exercise - Five woman undergoing neoadjuvant chemotherapy for breast cancer will be randomized to an exercise protocol supervised by an experienced personal trainer. The exercise will be administered three times a week for the 4-6 months of neoadjuvant chemotherapy. The exercise protocol will consist of activities including walking/running up to a mile, calisthenics, and light weightlifting.

#Eligibility Criteria: Inclusion Criteria: * Receiving neoadjuvant chemotherapy for breast cancer at one of the UT Southwestern hospitals or affiliates (Simmons Cancer Center, Parkland Hospital) * No evidence of metastatic disease as confirmed by routine staging * 18 - 70 year old female * Karnofsky score >80% * Body Mass Index >25 kg/m2 * Able to speak, read and understand the English language * Ability to understand and willingness to sign a written informed consent document * All races and ethnicities will be eligible. Exclusion Criteria: * Unable to speak, read and understand the English language * Patients may not be involved in other trials evaluating the efficacy of neoadjuvant therapy * Insulin-dependent diabetic patients. * Known to be pregnant or planning to become pregnant during the study. * Subjects are prohibited from being on other cancer treatments aside from what their treating medical oncologist has prescribed, primarily additional chemotherapies. ##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

{ "NCT_ID" : "NCT01506973", "Brief_Title" : "A Phase I/II/Pharmacodynamic Study of Hydroxychloroquine in Combination With Gemcitabine/Abraxane to Inhibit Autophagy in Pancreatic Cancer", "Official_title" : "A Phase I/II/Pharmacodynamic Study of Hydroxychloroquine in Combination With Gemcitabine/Abraxane to Inhibit Autophagy in Pancreatic Cancer", "Conditions" : ["Advanced Adenocarcinoma", "Metastatic Adenocarcinoma"], "Interventions" : ["Drug: Abraxane", "Drug: Hydroxychloroquine (HCQ)", "Drug: Gemcitabine"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary In this Phase I/II clinical trial, the investigators seek to pilot the addition of Hydroxychloroquine (HCQ) to a commonly-used front-line therapy of pancreatic cancer, gemcitabine/nab-paclitaxel. The investigators plan a run-in to define tolerable doses, and will explore doses of 800 and 1200 mg/day in successive cohorts of 6 patients. The investigators will assess toxicity continuously, and determine the dose for the Phase II trial based on standard toxicity criteria. The correlative endpoints of this trial are directed to the pharmacokinetics of HCQ, and pharmacokinetic model of HCQ based on data from several ongoing trials, and the data from these patients will contribute to refining the model. The investigators will analyze both measured and model-predicted indices for their relationship to autophagy induction. Autophagy will be assessed as the accumulation of autophagocytic vesicles in the PMNs of treated patients, together with the induction of the expression of autophagy-related proteins on western analysis, quantitated by densitometry. The investigators will document the rates of metabolic response as a consequence of treatment, as a therapeutic marker that may be related to the degree of autophagy inhibition. Since the investigators have previously demonstrated a key role of JNK1 in the induction of autophagy by chemotherapy, the investigators will analyze archival tumor materials to determine variability in this marker, as a baseline for potential future trials. Finally, this study will incorporate metabolic profiling by mass spectrometry, which will be related to mutations (including Kras) in pretreatment tumor specimens. Mutational analysis will be accomplished by targeted sequencing or by next-generation sequencing, and the need for fresh tissue for all these endpoints will require patients to have a biopsy performed before treatment at at 6-8 weeks after beginning treatment. In the previous study of the Hh inhibitor GDC-0973 with the same chemotherapy, the investigators were able to obtain repeat biopsies successfully on all patients. The importance of these biopsies, to move the science forward in an era in which the tools now exist to provide meaningful correlative science, cannot be overstated. Detailed Description Recent strategies have focused on improving the efficacy of gemcitabine either by improving the method of delivery, or by combining gemcitabine with other non-cross resistant agents. A sequence of Phase III combination studies of gemcitabine in combination (with oxaliplatin, and with the targeted therapies bevacizumab and cetuximab) have been negative, though based on strikingly positive Phase II data generated in cancer centers. Several studies suggest that taxanes are active in pancreatic cancer, but a randomized trial of gemcitabine with taxanes has not been preformed, probably on the basis that the differences in Phase II were insufficiently persuasive. The development of a novel taxane conjugate with albumin, abraxane, with established activity in breast cancer, prompted a Phase II trial of gemcitabine/abraxane by Von Hoff (6). Phase I/II data were highly promising, with response rates of the order of 40%, with tolerable toxicity, and a one-year survival of about 48%. A phase III trial of gemcitabine versus gemcitabine/abraxane is in progress, and based on these promising data has served as the control chemotherapy for previous SU2C trials. The development of a more intensive, but toxic regimen (FOLFIRINOX) in no way diminishes the enthusiasm for this chemotherapy backbone, given the activity in Phase II trials that appears comparable (7). Given the promise of this regimen, and the possibility of making a substantial improvement in outcome with additional targeted interventions, we propose to continue to use this regimen in the current study. Of particular interest in extending these studies to pancreatic cancer is the finding that autophagy inhibition is particularly deleterious to cell lines bearing a mutant Kras protein. Additional studies as part of the SU2C pancreatic cancer project reveal that an autophagy program is activated in the presence of mutant Kras, and thus prompts the testing of this strategy in a setting in which Kras is commonly (about 85%) mutated (SU2C, unpublished data). #Intervention - DRUG : Hydroxychloroquine (HCQ) - DRUG : Gemcitabine - DRUG : Abraxane

#Eligibility Criteria: Inclusion Criteria: * Patients must have histologically or cytologically documented advanced or metastatic adenocarcinoma of the pancreas. * Patients must have measurable disease as defined by the RECIST criteria as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as 20mm with conventional techniques on either CT or MRI. Marker (CA19 <= age <= 9 or CEA) elevation alone is insufficient for entry. * Patients may have had prior adjuvant treatment for pancreatic cancer. The last dose of chemotherapy must have been 4 months prior to study entry. * Patients with prior radiotherapy are acceptable. It must be at least 4 months since administration of radiation therapy and all signs of toxicity must have abated. * Patients must be age >= 18 years. * Patients must have an ECOG performance status of 0 <= age <= 1. * The following required Initial Laboratory Values should be obtained within 4 weeks of the start of treatment: * Granulocytes 1,500/ml * Platelet Count 100,000/ml * Creatinine 1.5 x upper limit of normal * Bilirubin 1.5 x upper limit of normal * AST 5 x upper limit of normal * Patients must not be pregnant or lactating as chemotherapy is thought to present substantial risk to the fetus/infant. * Patients must have an accessible primary tumor or metastasis, and be willing to have a pre-treatment and post-treatment tumor biopsy (at 6 to 8 weeks after beginning). * Patients must have a life expectancy of greater than three months. * Patients must have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Patients may not be receiving any other investigational agents * Known allergy to HCQ * Patients with previous treatment with abraxane. * Patients on therapeutic doses of Coumadin ( 1 mg daily). The use of therapeutic or prophylactic low molecular weight heparin or fragmin is permitted. * Patients with known G6PD deficiency, severe psoriasis, porphyria, macular degeneration or severe diabetic retinopathy are ineligible because of the potential for greater HCQ toxicity. ##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

{ "NCT_ID" : "NCT02793466", "Brief_Title" : "Durvalumab in Pediatric and Adolescent Patients", "Official_title" : "A Phase I, Open-Label, Single Institution Study to Assess the Safety, Tolerability, and Pharmacokinetics of Durvalumab in Pediatric Patients With Relapsed or Refractory Solid Tumors, Lymphoma, and Central Nervous System Tumors", "Conditions" : ["Solid Tumor", "Lymphoma", "Central Nervous System Tumors"], "Interventions" : ["Drug: Durvalumab; MEDI4736"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This clinical trial is the first clinical trial to study Durvalumab, a checkpoint inhibitor which stimulates the patient's own immune system to act against cancer cells in children and adolescents. This trial will assess the safety and tolerability of Durvalumab in children and adolescents and also study how Durvalumab is processed in their bodies. Detailed Description This trial will assess the safety and tolerability of Durvalumab in children and adolescents and also study how Durvalumab is processed in their bodies. #Intervention - DRUG : Durvalumab; MEDI4736 - IV Infusion every 2 weeks for a maximum of 26 - Other Names : - Durvalumab

#Eligibility Criteria: Inclusion Criteria: * Age: Patients must be >12 months and <18 years at the time of study enrollment. * Diagnosis: Patient must have disease that is either refractory to frontline treatment or have relapsed. Patient must have had histologic verification of a solid tumor (including lymphoma and CNS tumors) at the time of original diagnosis or relapse with the following exceptions: * Patients with germ cell tumors (both CNS and non-CNS) that have elevated tumor markers (e.g. α-fetoprotein, β-human chorionic gonadotropin, inhibin A/B) and radiographic evidence of disease. * Patients with diffuse intrinsic pontine glioma (DIPG) diagnosed by radiographic studies. * Disease Status: Patients must have either measurable or evaluable disease that can be accurately assessed at baseline by computerized tomography (CT) or magnetic resonance imaging (MRI) and is suitable for repeated assessment with the following exception: * Patients with a third relapse of osteosarcoma and no measurable disease after surgical resection will be eligible for this study. * Therapeutic Options: Patient's current disease state must be one for which there is no known curative therapy. * Performance Level: Karnofsky >= 50 for patients > 16 years and Lansky >= 50 for patients <= 16 years. Patients who are unable to walk because of paralysis, but who can actively sit up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score. See Appendix I for scoring guidelines. * Organ Function Requirements: * Adequate organ and bone marrow function as defined below: * Absolute neutrophil count >= 750/mm3 * Platelets >= 75,000/mm3 . Patients must be transfusion independent and should not have received a platelet transfusion within 5 days of enrollment. * Hemoglobin >=8.0 g/dL. Patients may receive PRBC transfusion. * Adequate renal function as defined by: Creatinine clearance or radioisotope GFR > 70ml/min/m 2 * Total serum bilirubin (conjugated plus unconjugated) <=1.5 x upper limit of normal (ULN) for age. For patients with Hepatocellular Carcinoma (HCC) or patients with documented/suspected Gilbert's disease, bilirubin <=3x ULN. * In patients with no liver metastasis: AST and ALT <=2.5 x ULN * In patients with HCC or liver metastasis: AST or ALT <=5 x ULN * Adequate cardiac function as indicated by shortening fraction of > 28% by echocardiogram or ejection fraction of >= 55% by radionuclide angiogram. * Informed Consent: Provision of signed and dated written informed consent (parent/legal guardian if patient <18 years) and assent (from patients aged >7 years) prior to any study specific procedures, sampling and analyses, including screening evaluations. * Female patients must either be of non-reproductive potential or must have a negative serum pregnancy test upon study entry. * Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits as well as follow up examinations. Exclusion Criteria: * Prior therapy: * Nitrosourea or mitomycin C within 6 weeks of the first dose of study treatment. * Any investigational agents or study drugs from a previous clinical study within 28 days of the first dose of study treatment. Patient may be enrolled in other non-therapeutic studies. * Hematopoietic growth factors: Within 14 days of the last dose of a long acting growth factor (e.g. Neulasta) or within 7 days of receiving a short acting growth factor. This does not apply to erythropoetin. * Monoclonal antibodies: Less than 3 half-lives or 28 days (whichever is shorter) after the last dose of monoclonal antibody, and without resolution of all known toxicity of the antibody. * Any other chemotherapy, immunotherapy or anticancer agents within 4 weeks of the first dose of study treatment. For agents with known adverse events occurring beyond 3 weeks of administration after administration, this period must be extended beyond the time during which adverse events are known to occur. * Any previous systemic exposure to a PD-1 or PD-L1 inhibitor, including Durvalumab. * Major surgery (excluding placement of vascular access and needle biopsies) within 2 weeks of the first dose of study treatment. * Radiotherapy within two weeks for local palliative XRT or within 6 weeks if craniospinal XRT or if >= 50% radiation of pelvis. * Current or prior use of immunosuppressive medication within 28 days before the first dose of Durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. * Any prior allogeneic BMT/HSCT. * Autologous BMT/HSCT within 90 days. * All prior acute toxicities from medical therapy or radiation therapy should resolve to meet the baseline inclusion criteria in regards to organ function requirement. All other prior acute toxicities that are not part of the baseline organ function requirements must improve to <= Grade 1 as defined in Section 5.1.1 and using CTCAE Criteria Version 4.03. * Any of the following cardiac criteria: * Mean resting corrected QT interval (QTc) > 470 msec obtained from at least 2 electrocardiograms (ECGs). * Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block) * Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years or any concomitant medication known to prolong the QT interval. * Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements * Any prior Grade >=3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE >Grade 1. * Active or prior documented autoimmune disease within the past 2 years. NOTE: Patients with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded. Patients with hypothyroidism as a result of irradiation or thyroidectomy are also not excluded. * Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis). * History of primary immunodeficiency. * Any underlying interstitial lung disease. * Brain metastases or spinal cord compression unless asymptomatic, treated and stable for at least 1 month prior to entry into the study. * Ongoing or expected need for systemic corticosteroids >=10mg/day. * Known history orf previous clinical diagnosis of tuberculosis. * Receipt of live attenuated vaccination within 30 days prior to receiving study treatment. Inactivated viruses, such as those in the influenza vaccine, are permitted * History of another primary malignancy within 5 years prior to starting study treatment, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ and the disease under study. * Pregnancy or Breast-Feeding: Pregnant patients are ineligible for this study due to the unknown teratogenic effects of this agent. Pregnancy tests must be obtained in females of childbearing potential prior to enrollment. * Post-menarchal females and males who are sexually active with women of childbearing potential who are not employing/willing to employ an effective method of birth control. * Clinically Significant Unrelated Systemic Illness: Patients with serious infections or significant pulmonary, hepatic, renal, or other end-organ dysfunction which in the judgment of the Principal or Co-Investigators would compromise the patient's ability to tolerate prescribed chemotherapy or are likely to interfere with the study procedures or results will not be eligible. * Patient with HIV, Hepatitis B, or Hepatitis C defined by the following serology results: * Positive human immunodeficiency virus (HIV) antibody. * Positive hepatitis B surface antigen (HBsAg) and positive hepatitis B core (HBc) antibody or undetectable hepatitis B (HBV) deoxyribonucleic acid (DNA) by quantitative polymerase chain reaction (PCR) testing. * Positive hepatitis C (HCV) antibody or positive HCV ribonucleic acid (RNA) by quantitative PCR. * Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results. * History of hypersensitivity to Durvalumab or any excipient. ##Sex : ALL ##Ages : - Minimum Age : 1 Year - Maximum Age : 17 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT04954378", "Brief_Title" : "Radiomics Based on Multimodal Imaging in Predicting Staging and Prognosis of Pancreatic Cancer", "Official_title" : "Radiomics Based on Multimodal Imaging in Predicting Staging and Prognosis of Pancreatic Cancer", "Conditions" : ["Pancreatic Ductal Adenocarcinoma"], "Interventions" : ["Diagnostic Test: radiomics"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary Retrospectively analyzed radiomics features of pancreatic ductal adenocarcinoma to predict staging and prognosis Detailed Description Pancreatic cancer is the most malignant tumor of the digestive system and the seventh leading cause of cancer-related death worldwide.The rate of lymph node metastasis in pancreatic cancer is as high as 59%.Lymph node metastasis is an important prognostic factor, which is closely associated with poor prognosis of pancreatic cancer patients.Preoperative accurate prediction of lymph node status has important clinical value.At present, the preoperative LN status of pancreatic cancer patients is mainly evaluated by conventional imaging methods such as CT and MRI.The accuracy of evaluating LN state only from the perspective of morphology is poor.Ductal adenocarcinoma of the pancreas is highly malignant, has a median disease-free survival of only about 1 year, and most pancreatic cancer patients eventually relapse.At present, TNM staging system is mainly used for prognosis evaluation.However, even among patients with the same TNM stage, the prognosis is still significantly different, which reflects the lack of prognostic information provided by the TNM stage.Imaging omics extracts a large number of quantitative features from medical images in a high-throughput manner to enable non-invasive analysis of intra-tumor heterogeneity.In this study, we planned to construct a prediction study of preoperative lymph node metastasis and prognosis of pancreatic cancer based on multimodal imaging, so as to provide a basis for clinical treatment decision and prognosis. #Intervention - DIAGNOSTIC_TEST : radiomics

#Eligibility Criteria: Inclusion Criteria: * radical resection was performed, and histopathologically confirmed pancreatic ductal adenocarcinoma and lymph node status;2) CT and/or MRI enhancement examinations were performed 2 weeks before surgery;3) Patients with complete clinical data Exclusion Criteria: * (1)Patients who received radiotherapy or chemotherapy before preoperative imaging examination;2) Poor image quality. ##Sex : ALL ##Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01441752", "Brief_Title" : "Efficacy Study of Integrated TCM Combined With Chemotherapy in Postoperative NSCLC Patients", "Official_title" : "State Administration of Traditional Chinese Medicine of Shanghai", "Conditions" : ["Non-small Cell Lung Cancer"], "Interventions" : ["Drug: placebo", "Drug: TCM"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "DOUBLE" } }

#Study Description Brief Summary The investigators performed a multi-center, randomized, controlled, double-blind, prospective study on evaluating effect of chemotherapy combined with or without integrated TCM on quality of life (QOL) of postoperative Non-small Cell Lung Cancer (NSCLC) patients. The investigators plan to involve 600 cases for observation in 3 years (300 cases for each group), expecting that QOL of postoperative NSCLC patients can be improved by integrated TCM combined with chemotherapy compared to that by chemotherapy alone. Detailed Description At present the high rate of recurrence and metastasis of postoperative non-small cell lung cancer (NSCLC) patients is one of the leading causes resulting in failure of treating lung cancer. More than 35% of postoperative lung cancer patients with stage I died in 5 years due to recurrence or metastasis; the 5-year survival rates of stage II, IIIa, IIIb were 31%, 17.9% and 11.7% respectively. The survival rate was improved by 5% with adjuvant chemotherapy after resection, so regimen consist of platinum-based two chemical medicines are commended as the adjuvant chemotherapy for treating postoperative NSCLC patients, but the toxicity and side effects of chemotherapy can decrease quality of life (QOL) of patients. Literature and our preliminary studies have shown that traditional Chinese medicine (TCM) can prolong survival and improve QOL, but high-level evidences are needed. The investigators perform a randomized, double-blind study in NSCLC patients after complete resection with stage I-III. Patients are randomized over observational group (TCM granules plus chemotherapy), and control group (TCM placebo plus chemotherapy). The investigators will observe 4 treatment periods, after that the observational group will be treated for another 4 months with integrated TCM combined with western medicine treatment (oral TCM medicines plus TCM intravenous injections), and there is no intervene measures in control group. Regular follow-up will be arranged. The primary efficacy assessments are: QOL (QLQ-C30 scales); Secondary efficacy assessments are: (1) 2-year disease-free survival rate; (2) disease-free survival; other efficacy assessments are: (1) TCM symptoms changes; (2) tumor markers (CEA, CA-125 and CYFRA21-1) and so on. Toxicity, side effects and security of the treatments will be assessed at the same time. The investigators expect that integrated TCM combined with Western medicine treatment has a better efficacy on improving QOL of patients, prolonging disease-free survival time than that of chemotherapy treatment. Therefore our study can provide evidences for optimizing and promoting integrated TCM combined with Western Medicine treatment. #Intervention - DRUG : TCM - three types with functions such as benefiting Qi recipe, benefiting Yin recipe and detoxication and resolving masses recipe. - Other Names : - Prescriptions from Professor Liu Jiaxiang - DRUG : placebo - three types with functions such as benefiting Qi recipe, benefiting Yin recipe and detoxication and resolving masses recipe，with the same color, smell ，taste weight and package

#Eligibility Criteria: Inclusion Criteria: * Meet the diagnostic criteria of primary bronchial lung cancer, and pathologically or cytologically confirmed of NSCLC (squamouscarcinoma, adenocarcinoma, adenosquamous carcinoma and large cell carcinoma) patients; * Age > 18 years; * TCM syndromes are Yin deficiency, Qi deficiency, deficiency of both Qi and Yin, deficiency of both Spleen and Kidney; * Physical status score (ECOG PS) <= 2 scores; * Stage Ib ~ Ⅲb with complete resection, chemotherapy is performed in 6 weeks after resection, including tumor size > 2cm of stage Ia; * Blood routine: N > 1.5×109/L、PLT > 100×109/L, normal liver function and kidney function; * Voluntarily involved to clinical study and sign informed consent. Exclusion Criteria: * Suffering from other primary malignant tumor in 5 years; * Incomplete resection or uncertain to take resection; * Serious disease of heart, liver, kidney with severe dysfunction; * Pregnancy or breast-feeding women; * Mental or cognitive disorders which would influence judgment of QOL in this study; * During or had adjuvant chemotherapy; * Being participating other drug trials; * Allergy to the drug in our study. ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Maximum Age : 75 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: Yes

{ "NCT_ID" : "NCT05420909", "Brief_Title" : "A Study of Overall Survival in Participants With Metastatic Colorectal Cancer (mCRC)", "Official_title" : "Overall Survival for Metastatic Colorectal Cancer Patients Matched to CHECKMATE-142", "Conditions" : ["Metastatic Colorectal Cancer (mCRC)"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary The purpose of this study is to estimate the overall survival (OS) for US participants diagnosed with metastatic colorectal cancer (mCRC) by using Flatiron Health's individual patient level data.

#Eligibility Criteria: Inclusion Criteria: * Metastatic Colorectal Cancer (CRC) participants in the Flatiron database as defined by: * Diagnosed with CRC (ICD-9 153.x or 154.x or ICD-10 C18x, or C19x, or C20x, or C21x) * Pathology consistent with CRC * At least two documented clinical visits on or after January 1, 2013 * Evidence of Stage IV or recurrent metastatic CRC diagnosed on or after January 1, 2013 * Participants with high levels of microsatellite instability (MSI-H) and/or mismatch repair (MMR) protein deficiency (dMMR) * Participants who received 2L therapy of interest on or after the initial mCRC diagnosis date * Participants who had at least 1 month medical data during the prior to and post periods; however, participants who died within 1 month after the index date will not be excluded from the study Exclusion Criteria: * Participants <18 years at index date * Participants who received clinical trial drug during the prior or post periods ##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

{ "NCT_ID" : "NCT02352948", "Brief_Title" : "A Global Study to Assess the Effects of MEDI4736 (Durvalumab), Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer", "Official_title" : "A Phase III, Open Label, Randomised, Multi-centre, International Study of MEDI4736, Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV) Who Have Received at Least Two Prior Systemic Treatment Regimens Including One Platinum Based Chemotherapy Regimen and Do Not Have Known EGFR TK Activating Mutations or ALK Rearrangements (ARCTIC).", "Conditions" : ["Non - Small Cell Lung Cancer NSCLC"], "Interventions" : ["Drug: tremelimumab (anti-CTLA4)", "Drug: Gemcitabine", "Drug: Vinorelbine", "Drug: MEDI4736 (durvalumab) in combination with tremelimumab (anti-CTLA4)", "Drug: MEDI4736 (durvalumab)", "Drug: Erlotinib"], "Location_Countries" : ["Australia", "Poland", "Taiwan", "Russian Federation", "Greece", "Chile", "Israel", "Singapore", "France", "Serbia", "Belgium", "Netherlands", "Hungary", "Japan", "Spain", "Hong Kong", "Germany", "Czechia", "Romania", "Korea, Republic of", "Italy", "Canada", "Thailand", "United States", "United Kingdom", "Bulgaria"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary 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 in NSCLC patients with PD-L1-negative tumours in the treatment of male and female patients with locally advanced or metastatic NSCLC (Stage IIIB-IV), who have received at least 2 prior systemic treatment regimens including 1 platinum-based chemotherapy regimen for NSCLC. Patients with known EGFR (Epidermal growth factor receptor) tyrosine kinase (TK) activating mutations and anaplastic lymphoma kinase (ALK) rearrangements are not eligible for the study (prospective testing is not planned within this study). The Standard of Care options are: an EGFR tyrosine kinase inhibitor (erlotinib \[TARCEVA®\]), gemcitabine or vinorelbine (NAVELBINE®) Detailed Description The study has an umbrella design with 2 sub-studies: sub-study A (randomizing patients with PD-L1 positive tumours 1:1 into MEDI4736 (durvalumab) vs. Standard of Care) and sub-study B (randomizing patients with PD-L1 negative tumours 2:3:1:2 into MEDI4736 (durvalumab) vs. MEDI4736 (durvalumab) plus tremelimumab vs. tremelimumab vs. Standard of Care. The two substudies may have different durations of recruitment periods due to differences in patient population (PD-L1 expression). They may not run concurrently with start and completion of recruitment potentially occurring at different time points. #Intervention - DRUG : MEDI4736 (durvalumab) - MEDI4736 (durvalumab) treatment by intravenous infusion - DRUG : Vinorelbine - Vinorelbine by intravenous infusion. Administered at a dose of 30 mg/m2 iv on Days 1, 8, 15 and 22 of a 28-day cycle. - DRUG : Gemcitabine - Gemcitabine by intravenous infusion. Administered at a dose of 1000 mg/m2 iv over 30 minutes on Days 1, 8, and 15 of a 28-day cycle. - DRUG : Erlotinib - Erlotinib administered at a dose of 150 mg once daily as a tablet for oral administration - DRUG : MEDI4736 (durvalumab) in combination with tremelimumab (anti-CTLA4) - MEDI4736 (durvalumab) in combination with tremelimumab (anti-CTLA4) treatment by intravenous infusion - DRUG : tremelimumab (anti-CTLA4) - tremelimumab (anti-CTLA4) treatment by intravenous infusion

#Eligibility Criteria: 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 life expectancy more than 12 weeks Exclusion Criteria: * Prior exposure to any anti-PD-1 or anti-PD-L1 antibody or anti-CTLA4 * Brain metastases or spinal cord compression unless asymptomatic, treated and stable (not requiring steroids) * Active or prior documented autoimmune disease within the past 2 years * Evidence of severe or uncontrolled systemic disease, including active bleeding diatheses or active infections including hepatitis B, C and HIV * Any unresolved toxicity CTCAE (Common Terminology Criteria of Adverse Events) >Grade 2 from previous anti-cancer therapy * Known EGFR TK activating mutations or ALK rearrangements * Any prior Grade >=3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE >Grade 1 * Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis) ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Maximum Age : 130 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03101280", "Brief_Title" : "A Combination Study of Rucaparib and Atezolizumab in Participants With Advanced Gynecologic Cancers and Triple-Negative Breast Cancer", "Official_title" : "A Phase IB Combination Study of Rucaparib (CO-338) and Atezolizumab (MPDL3280A) in Participants With Advanced Gynecologic Cancers and Triple-Negative Breast Cancer", "Conditions" : ["Gynecologic Neoplasms"], "Interventions" : ["Drug: Atezolizumab", "Drug: Rucaparib"], "Location_Countries" : ["Australia", "Spain", "United Kingdom", "France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This is a Phase Ib, open-label, non-randomized study in patients with previously treated advanced ovarian or endometrial cancer (Part 1) and platinum-sensitive ovarian cancer or triple-negative breast cancer (TNBC) (Part 2) to investigate the dose, safety, pharmacokinetics, and preliminary efficacy of rucaparib in combination with atezolizumab. The study is conducted in 2 parts: a Dose-Finding Phase (Part 1) and a Dose-Expansion Phase (Part 2) #Intervention - DRUG : Atezolizumab - Atezolizumab 1200 mg (equivalent to an average body weight-based dose of 15 milligrams per kilogram \[mg/kg\]) will be administered by IV infusion once every 3 weeks, corresponding to a 21-day treatment cycle. Participants will receive atezolizumab starting on Cycle 1, Day 1. Participants deriving clinical benefit will be allowed to continue on study treatment until the absence of unacceptable toxicity or compelling evidence of disease progression. - Other Names : - MPDL3280A; TECENTRIQ - DRUG : Rucaparib - The starting dosage level of rucaparib for Part 1 is 400 mg PO BID during a 21-day treatment cycle. During Part 1, the rucaparib doses were increased up to a maximum of 600 mg PO BID using a standard 3 + 3 dose escalation. RP2D was identified as 600 mg BID. During Part 2 of the study, rucaparib will be dosed at the RP2D determined in Part 1. Participants in Part 1 of the study will receive rucaparib starting on Cycle 1, Day 1. During Part 2, participants will receive rucaparib monotherapy during a 21-day run-in period. After completion of the rucaparib run-in period and the first on-treatment biopsy between Days 15 and 21 of the run-in period, participants will begin Cycle 1, Day 1 of the rucaparib. Participants deriving clinical benefit will be allowed to continue on study treatment until the absence of unacceptable toxicity or compelling evidence of disease progression. - Other Names : - CO-338

#Eligibility Criteria: Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * A life expectancy of at least 3 months * Have disease that is measurable as according to RECIST v1.1 * Have sufficient archival formalin-fixed paraffin-embedded (FFPE) tumor tissue available for planned analyses * For Part 1, have a histologically confirmed diagnosis of ovarian or endometrial cancer, and have received at least one line of prior therapy for metastatic disease * For Part 2 ONLY, have disease that can be safely biopsied * For Part 2 ONLY, have a deleterious germline or somatic breast cancer susceptibility gene 1 (BRCA1) or BRCA2 mutation or tumors that are wild-type BRCA but show high levels of loss of heterozygosity (LOH) (tBRCAwt/LOHhigh) signature * For Part 2 Cohort 1 (ovarian cancer), high-grade serous or Grade 3 endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer (PPC) * For Part 2 Cohort 1, have received at least one and no more than two lines of prior platinum-containing therapy and progressed after the most recent platinum therapy in a platinum-sensitive timeframe * For Part 2 ONLY, Cohort 1, have a CA125 measurement that is greater than 2 times the upper limit of normal (ULN) * For Part 2 Cohort 2 (TNBC), metastatic, histologically confirmed estrogen receptor (ER)-negative, progesterone receptor-negative, and HER2-negative adenocarcinoma of the breast per local laboratory assessment * For Part 2 Cohort 2, radiologic/objective evidence of recurrence or disease progression after one line of chemotherapy for TNBC in the metastatic setting * Have adequate organ function Exclusion Criteria: * History of prior malignancy except a) curatively treated non-melanoma skin cancer, b) solid tumor treated curatively more than 3 years ago without evidence of recurrence, c) For Cohort 1 (ovarian cancer): breast cancer with no evidence of disease or inactive for at least 3 years, and d) synchronous endometrial cancer (Stage 1A) with ovarian cancer * Treatment with chemotherapy, radiation, hormones (except corticosteroids and megestrol acetate), or other anticancer therapies less than or equal to (<=) 14 days prior to first dose of study treatment * Preexisting duodenal stent and/or any gastrointestinal disorder or defect that would, in the opinion of the investigator, interfere with absorption of rucaparib * Symptomatic and/or untreated central nervous system metastases * Prior treatment with any poly adenosine diphosphate-ribose polymerase (PARP) inhibitor ##Sex : FEMALE ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03394885", "Brief_Title" : "Atezolizumab With Neoadjuvant Chemotherapy for Patients With Newly-Diagnosed Advanced-Stage Ovarian Cancer", "Official_title" : "Atezolizumab in Combination With Neoadjuvant Chemotherapy and Interval Cytoreductive Surgery for Patients With Newly-Diagnosed Advanced-Stage Epithelial Ovarian Cancer", "Conditions" : ["Ovarian Cancer", "Ovarian Neoplasms"], "Interventions" : ["Drug: Paclitaxel", "Drug: Atezolizumab", "Drug: Bevacizumab", "Drug: Carboplatin"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1", "PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The main purpose of this study is to validate a safe dose of atezolizumab with dose-dense paclitaxel and carboplatin when utilized with neoadjuvant chemotherapy and interval cytoreductive surgery followed by maintenance atezolizumab in women with advanced ovarian cancer. Detailed Description This is a Phase IB non-randomized, single-arm, open-label study of atezolizumab in combination with primary NACT-ICS in patients with advanced-stage epithelial ovarian cancer. The target population is women with previously untreated epithelial ovarian cancer (including fallopian tube and primary peritoneal cancer) with advanced stage (FIGO III-IV) disease suitable for NACT and ICS. The following regimen will be administered every 3 weeks for 3 cycles prior to ICS, then for 3 cycles following ICS: * Carboplatin AUC = 5 or 6 IV, D1 of each cycle * Paclitaxel 70 to 80mg/m2 IV, over one hour, on D1, 8, 15 of each cycle * Atezolizumab 1200mg IV D1 of each cycle of chemotherapy and will be continued as maintenance therapy every 3 weeks until there is a lack of clinical benefit, unacceptable toxicity, or a total duration of 18 months. * Bevacizumab (15 mg/kg IV every 3 weeks) may be added at cycle 5 of chemotherapy as per FDA approval. Those who opt for bevacizumab will receive chemotherapy, atezolizumab, and bevacizumab for cycles 5 and 6 followed by atezolizumab and bevacizumab maintenance. Maintenance bevacizumab will be given for a total duration of 16 cycles. Patients who have completed chemotherapy may opt for bevacizumab in the maintenance setting only if the amendment to add bevacizumab was not approved before after they started maintenance therapy. * Upon completion of concurrent chemotherapy and atezolizumab therapy, patients will commence maintenance treatment with atezolizumab + bevacizumab for a total of up 16 cycles of maintenance therapy (22 total cycles of atezolizumab, and 18 total cycles of bevacizumab). Each cycle is 21 days in duration and will be administered in the outpatient setting. Limited individualized flexibility in dose assignment (as noted) is permitted per physician discretion in regards to advanced-stage disease, nutritional status, ascites, non-physiologic creatinine measurements, and other comorbidities. Three cycles of NACT with atezolizumab will be administered every 3 weeks prior to ICS (occurring between cycles 3 and 4) followed by 3 additional cycles (cycles 4-6) of chemotherapy with atezolizumab. Surgery must be performed after the third course of chemotherapy as soon as nadir counts permit, but preferably within six weeks after the completion of the third chemotherapy cycle. Fourth cycle of chemotherapy is to be administered as soon as possible, but preferably no more than six weeks after ICS. Safety monitoring, including assessment for irAEs, will occur at each cycle and for 90 days after the last administration of atezolizumab or until start of next anti-cancer regimen, whichever occurs first. Image assessment by CT scan or MRI will be performed at baseline, prior to ICS to assess response, after completion of 6 cycles of chemotherapy with atezolizumab to assess response at end of chemotherapy treatment, and as clinically indicated during the maintenance phase and after completion of study treatment to assess PFS. Disease progression/recurrence will be defined per RECIST criteria and will not include isolated asymptomatic progression on the basis of CA125 levels. Immune function analysis will be performed on blood and tumor samples obtained at two time points: 1. confirmatory biopsy prior to start of therapy and 2. ICS. It is estimated that 40 patients will be enrolled at an accrual rate of 3-5 patients/month and followed for a median of 3 years. #Intervention - DRUG : Atezolizumab - 1200mg IV q3weeks - Other Names : - Tecentriq - DRUG : Carboplatin - 5-6mg/ML IV q3 weeks - Other Names : - Paraplatin - DRUG : Paclitaxel - 70-80 mg/m2 IV q1 week - Other Names : - Taxol - DRUG : Bevacizumab - 15 mg/kg IV q3 weeks - Other Names : - Avastin

#Eligibility Criteria: Inclusion Criteria: * Signed Informed Consent Form (ICF) * Ability and willingness to comply with the requirements of the study protocol * Age >= 18 years * No prior treatment for primary advanced (stage III or IV) epithelial ovarian, fallopian tube, or primary peritoneal carcinoma * Confirmation of diagnosis (by surgical excisional/incisional biopsy or imaging-guided core biopsy), and patients for whom the plan of management will include NACT followed by ICS. The decision to proceed with NACT will be at the treating physician's discretion and include patients with advanced stage disease considered at low likelihood for optimal cytoreduction with primary debulking surgery. * All patients must have measurable disease per RECIST v1.1 Patients must meet the following criteria prior to initiation of study treatment: * Histology consistent with high-grade epithelial ovarian cancer (excluding mucinous carcinoma, clear cell carcinoma, and carcinosarcoma) * An adequate pre-treatment tumor biopsy is required to confirm histologic diagnosis. Acceptable options include laparoscopic biopsy or image-guided core needle biopsy (minimum of two cores). Fine needle aspiration (FNA) biopsy or cytology from ascites is not adequate. * Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to the first study treatment * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2 (see Appendix 6) * Peripheral neuropathy less than or equal to CTCAE Grade 1 * For female patients of childbearing potential, agreement (by patient) to use highly effective form(s) of contraception (i.e., one that results in a low failure rate [< 1% per year] when used consistently and correctly) and to continue its use at least until ICS or if ICS is not performed then 90 days post last dose of atezolizumab Exclusion Criteria: * Mucinous, low-grade histology, clear cell carcinoma, or carcinosarcoma * Prior systemic chemotherapy for epithelial ovarian, fallopian tube, or primary peritoneal cancer. * Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years. (Exceptions include basal cell or squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.) * AEs from prior anticancer therapy that have not resolved to Grade <= 1 except for alopecia * Bisphosphonate therapy for symptomatic hypercalcemia * Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease * Known primary central nervous system (CNS) malignancy or symptomatic CNS metastases * Pregnancy, lactation, or breastfeeding * Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies * Inability to comply with study and follow-up procedures * History or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis * History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan * Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications * History of HIV infection or active hepatitis B (chronic or acute) or hepatitis C infection * Active tuberculosis * Severe infections within 4 weeks prior to Cycle 1, Day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia * Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1 * Received oral or IV antibiotics within 2 weeks prior to Cycle 1, Day 1 * Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1 or anticipation that such a live, attenuated vaccine will be required during the study * Prior history of treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA4 or any other antibodies targeting co-stimulation or checkpoint pathways * Treatment with systemic immunostimulatory agents (including but not limited to interferon [IFN] alpha or interleukin [IL]-2) within 6 weeks or five half-lives of the drug (whichever is shorter) prior to Cycle 1, Day 1 * Treatment with investigational agent within 4 weeks prior to Cycle 1, Day 1 (or within five half lives of the investigational product, whichever is longer) * Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to Cycle 1, Day 1 * History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins * Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation ##Sex : FEMALE ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01586104", "Brief_Title" : "Intensity-Modulated Radiation Therapy in Treating Younger Patients With Lung Metastases", "Official_title" : "Cardiac-Sparing Whole Lung IMRT in Children and Young Adults With Lung Metastases: A Feasibility Study", "Conditions" : ["Adult Rhabdomyosarcoma", "Lung Metastases", "Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor", "Previously Treated Childhood Rhabdomyosarcoma", "Recurrent Adult Soft Tissue Sarcoma", "Recurrent Childhood Rhabdomyosarcoma", "Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor", "Recurrent Wilms Tumor and Other Childhood Kidney Tumors", "Stage IV Adult Soft Tissue Sarcoma", "Stage IV Wilms Tumor", "Stage V Wilms Tumor", "Unspecified Adult Solid Tumor, Protocol Specific", "Unspecified Childhood Solid Tumor, Protocol Specific"], "Interventions" : ["Radiation: intensity-modulated radiation therapy"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This pilot clinical trial studies intensity-modulated radiation therapy (IMRT) in treating younger patients with lung metastases. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Detailed Description OBJECTIVES: I. To demonstrate the feasibility of delivering cardiac-sparing IMRT in a multi-institutional setting with central quality control for children and young adults with metastatic tumors in the lungs. II. To prospectively determine the dosimetric advantages of whole lung IMRT treatment over standard whole lung irradiation by comparing treatment plans and different organ dose-volume histograms such as lungs, heart, thyroid gland, liver etc. in all patients enrolled in this study. III. To determine the short-term efficacy (lung-metastases free survival) and acute tolerance of whole lung IMRT at a minimum period of six months after IMRT. OUTLINE: Patients undergo cardiac-sparing whole lung IMRT. After completion of study treatment, patients are followed up for 1-5 years. #Intervention - RADIATION : intensity-modulated radiation therapy - Undergo cardiac-sparing whole lung IMRT - Other Names : - IMRT

#Eligibility Criteria: Inclusion Criteria: * Patients may have a Wilms tumor, Ewing Sarcoma, Rhabdomyosarcoma or any other metastatic pediatric malignancy; patients may have a single or multiple pulmonary metastases at the time of diagnosis or at the time of recurrence; a pulmonary metastasis may be defined as one pulmonary nodule >= 1 cm or more than one pulmonary nodules >= 0.5 cm; a biopsy of the nodules may be considered in case of doubt * The Karnofsky performance status must be >= 50 for patients > 16 years and the Lansky performance status must be >= 50 for patients =< 16 years * Patients must not have received prior radiation therapy to any part of the thorax * Adequate cardiac function defined as: * Shortening fraction of >= 27% by echocardiogram, or * Ejection fraction of >= 50% by radionuclide angiogram * Female patients of childbearing age must have a negative pregnancy test * Female patients who are lactating must agree to stop breast-feeding * Sexually active patients of childbearing potential must agree to use effective contraception Exclusion Criteria: * Patients enrolled on Children's Oncology Group protocols cannot be treated with whole lung IMRT on this study * Patients who have a prior history of radiation therapy to the thorax or adjacent regions cannot be entered on this protocol * Patient with Hodgkin's Lymphoma are not eligible for this study * Patients with mediastinal masses or other pulmonary masses requiring additional mediastinal or lung irradiation beyond the whole lung irradiation (WLI) doses stated in this protocol are ineligible for this study * Patients who may require concurrent or sequential irradiation to sites beyond the chest such as the neck, flank, abdomen or liver are eligible for this study ##Sex : ALL ##Ages : - Minimum Age : 1 Year - Maximum Age : 29 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03888599", "Brief_Title" : "Knowledge and Attitudes Towards Human Papillomavirus Infections and HPV Vaccination", "Official_title" : "Knowledge and Attitudes Towards Human Papillomavirus Infections and HPV Vaccination Among Undergraduate Health Students From Switzerland", "Conditions" : ["HPV-Related Cervical Carcinoma"], "Location_Countries" : ["Switzerland"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary A better understanding of the target audiences about HPV infection and HPV vaccination would surely allow for a better spread of this vaccination in Switzerland. In order to know if the target audiences are properly informed, we have decided to carry out a study evaluating their level of knowledge on a particular audience that are the men and women undergraduate nurse. #Intervention - BEHAVIORAL : knowledge questioannaire - , all enrolled undergraduate student received directly on your email the online questionnaire based on the 'Fluid Survey tool', which was an on line survey tool (https://fluidsurveys.com/)

#Eligibility Criteria: Inclusion Criteria: * Eligible women and men aged between 18 <= age <= 36 years * Understands study procedures and accepts voluntarily to participle of the study Exclusion Criteria: .Don't understand french language ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Maximum Age : 36 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT ##Accepts Healthy Volunteers: Yes

{ "NCT_ID" : "NCT02142738", "Brief_Title" : "Study of Pembrolizumab (MK-3475) Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (MK-3475-024/KEYNOTE-024)", "Official_title" : "A Randomized Open-Label Phase III Trial of Pembrolizumab Versus Platinum Based Chemotherapy in 1L Subjects With PD-L1 Strong Metastatic Non-Small Cell Lung Cancer", "Conditions" : ["Non-Small Cell Lung Carcinoma"], "Interventions" : ["Drug: Pemetrexed", "Drug: Gemcitabine", "Drug: Paclitaxel", "Drug: Pembrolizumab", "Drug: Cisplatin", "Drug: Carboplatin"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This is a study to assess the efficacy and safety of pembrolizumab (MK-3475/SCH 900475) compared to standard of care (SOC) platinum-based chemotherapies in the treatment of participants with previously untreated stage IV, programmed cell death ligand 1 (PD-L1) strong expressing Non-Small Cell Lung Cancer (NSCLC). The primary hypothesis of this study is that participants with PD-L1 strong NSCLC will have a longer Progression Free Survival (PFS), as assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) when treated with pembrolizumab than when treated with SOC platinum-based chemotherapies. With Amendment 09 (20 December 2017), once participants have achieved the study objective or the study has ended, participants will be discontinued from this study and enrolled in an extension study to continue protocol-defined assessments and treatment. Detailed Description Treatment Phase: Participants randomized to pembrolizumab will be treated for up to 35 cycles or until documented progressive disease (PD) occurs. Participants randomized to SOC chemotherapies will be treated with their randomized study drug for up to 4-6 cycles. After this, participants with non-squamous histologies may choose to be treated with maintenance pemetrexed for the remainder of the study or until disease progression, unacceptable adverse event(s) (AEs), intercurrent illness that prevents further administration of treatment, investigator's decision to withdraw the participant, noncompliance with study treatment or procedures requirements, the participant receives 35 treatments of study treatment (pembrolizumab arm only), or administrative reasons. Participants receiving pembrolizumab who stop drug administration after receiving 35 study treatments for reasons other than disease progression or intolerability, or participants who attain a complete response and stop study treatment may be eligible for retreatment with pembrolizumab upon experiencing disease progression. The decision to retreat with a second course of pembrolizumab will be at the discretion of the Investigator only if participants meet the criteria for retreatment and the study is ongoing. Retreatment (second course) is limited to 17 cycles. Participants randomized to receive SOC chemotherapy may be eligible to receive pembrolizumab if criteria to switch are met. Switch-Over Phase: This is only applicable for participants randomized to receive SOC. Eligible participants will be treated with pembrolizumab for the remainder of the study or until disease progression, unacceptable AEs, intercurrent illness that prevents further administration of treatment, investigator's decision to withdraw the participant, noncompliance with study treatment or procedures requirements, the participant receives 35 treatments of study treatment (pembrolizumab arm only), or administrative reasons. #Intervention - DRUG : Pembrolizumab - Pembrolizumab IV solution - Other Names : - MK-3475, SCH 900475, KEYTRUDA® - DRUG : Paclitaxel - Paclitaxel IV solution - DRUG : Carboplatin - Carboplatin IV solution - DRUG : Pemetrexed - Pemetrexed Lyophilized Powder for Infusion - DRUG : Cisplatin - Cisplatin IV solution - DRUG : Gemcitabine - Gemcitabine Lyophilized Powder for Infusion

#Eligibility Criteria: Inclusion Criteria: * Histological or cytological diagnosis of Stage IV NSCLC lacking epidermal growth factor receptor (EGFR)-sensitizing mutation and/or anaplastic lymphoma kinase (ALK) translocation, and received no prior systemic chemotherapy treatment for their metastatic NSCLC * At least one radiographically measurable lesion per RECIST 1.1 * Life expectancy of at least 3 months * Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status * Adequate organ function * No history of prior malignancy, with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or in situ cervical cancer, or has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy * Provided newly obtained formalin fixed tumor tissue from a biopsy of a tumor at the time of or AFTER the diagnosis of metastatic disease has been made AND from a site not previously irradiated * PD-L1 strong expressing tumor as determined by immunohistochemistry (IHC) at a central laboratory * Female participants must have a negative pregnancy test at screening if of childbearing potential or be of non-childbearing potential * Female participants of childbearing potential and male partners with female partners of childbearing potential must agree to use 2 adequate barrier methods of contraception during the study and for 120 days after last dose of study drug and up to 180 days after last dose of chemotherapy Exclusion Criteria: * EGFR sensitizing mutation and/or ALK translocation * Has received systemic therapy for the treatment of their stage IV NSCLC. Completion of treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as therapy was completed at least 6 months prior to the diagnosis of metastatic disease. * Currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of first dose of study drug * Tumor specimen is not evaluable for PD-L1 expression by the central laboratory * Receiving systemic steroid therapy < 3 days prior to first dose of study drug or receiving any other form of immunosuppressive medication * Expected to require any other form of systemic or localized antineoplastic therapy during the study * Received prior systemic cytotoxic chemotherapy, biological therapy, major surgery within 3 weeks of first dose of study drug; received thoracic radiation therapy of > 30 gray (Gy) within 6 months of first dose of study drug * Received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-PD-L1, anti-programmed cell death-ligand 2 (anti-PD-L2), anti-CD137 (4 <= age <= 1BB ligand, a member of the Tumor Necrosis Factor Receptor [TNFR] family), or anti-Cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways) * Has untreated central nervous system (CNS) metastases and/or carcinomatous meningitis * Active autoimmune disease that has required systemic treatment in past 2 years * Allogenic tissue/solid organ transplant * Interstitial lung disease or pneumonitis that has required oral or IV steroids * Received or will receive a live vaccine within 30 days prior to first dose of study drug * Active infection requiring IV systemic therapy * Known history of human immunodeficiency virus (HIV) * Known active tuberculosis, or hepatitis B or C * Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study * Is, at the time of signing informed consent, a regular user (including 'recreational use') of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol) * Pregnant or breastfeeding, or expecting to conceive or father children during the study and through 120 days after last dose of pembrolizumab or 180 days after last dose of SOC chemotherapy * Immediate family member who is investigational site or sponsor staff directly involved with this study ##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

{ "NCT_ID" : "NCT04335253", "Brief_Title" : "First-In-Human Study of EOS884448 in Participants with Advanced Cancers.", "Official_title" : "Phase I/IIa First-In-Human Study of EOS884448 in Participants with Advanced Cancers.", "Conditions" : ["Advanced Cancer"], "Interventions" : ["Drug: EOS884448"], "Location_Countries" : ["Belgium"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SEQUENTIAL", "Masking" : "NONE" } }

#Study Description Brief Summary IO-002 study is a multicenter, open-label, dose-escalation Phase I/IIa clinical study to evaluate the safety and tolerability, PK, PD, and antitumor activity of EOS884448 in participants with advanced cancers. Detailed Description Multicenter, open-label, dose-escalation Phase I/IIa clinical study to evaluate the safety and tolerability, PK, PD, and antitumor activity of EOS884448 in participants with advanced cancers. The study will consist in a dose-escalation phase to determine the MTD, the RP2D, and the safety of EOS884448 in participants with advanced cancers. #Intervention - DRUG : EOS884448 - Multiple Ascending Dose - Other Names : - EOS-448

#Eligibility Criteria: Inclusion Criteria: * Be willing to provide a signed written informed consent for the trial and consent for biopsies before and during administration of EOS884448 * Be more than18 years on day of signing informed consent. * Have histologically or cytologically confirmed advanced or metastatic cancer for whom no standard treatment is further available * Have evaluable disease, per RECIST v1.1 for solid tumor escalation or other criteria if indicated * Have an ECOG performance status of Grade 0 to 1. * Have adequate organ function. * Agree to use adequate contraception during the treatment if required. Exclusion Criteria: * Has received any anti-cancer therapy, unless at least 4 weeks (or 5 half-lives, whichever is shorter) since the last dose. * Has undergone major surgery within 5 weeks before initiating treatment. * Has received prior radiotherapy within 2 weeks of start of IP. * Has toxicity (except for alopecia) related to prior anti-cancer therapy, unless the toxicity is resolved, returned to baseline or Grade 1, or deemed irreversible. * Has known CNS metastases. * Has any condition requiring concurrent use of systemic immunosuppressants or corticosteroids. * Has uncontrolled or significant cardiovascular disease. * Has received vaccine containing live virus within 4 weeks. * Has known active or chronic viral hepatitis. * Has any known or underlying medical, psychiatric condition, and/or social situations that, in the opinion of the investigator, would limit compliance with study requirements. ##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

{ "NCT_ID" : "NCT05008224", "Brief_Title" : "Study of Safety and Efficacy of Pembrolizumab and Chemotherapy in Participants With Newly Diagnosed Classical Hodgkin Lymphoma (cHL) (MK-3475-C11/KEYNOTE-C11)", "Official_title" : "Phase 2 Study of Pembrolizumab and Chemotherapy in Patients With Newly Diagnosed Classical Hodgkin Lymphoma (KEYNOTE-C11)", "Conditions" : ["Classical Hodgkin Lymphoma"], "Interventions" : ["Biological: Pembrolizumab", "Drug: Doxorubicin", "Drug: Bleomycin", "Drug: Procarbazine", "Drug: Dacarbazine", "Drug: Prednisone", "Drug: Vincristine", "Drug: Cyclophosphamide", "Drug: Etoposide", "Drug: Vinblastine"], "Location_Countries" : ["Australia", "Italy", "Poland", "Canada", "Spain", "Turkey", "France", "Russian Federation", "United States", "Chile", "Israel"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SEQUENTIAL", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475) monotherapy, followed by chemotherapy, followed by pembrolizumab consolidation. The primary hypothesis of the study is that the complete response (CR) rate at the end of study intervention according to Lugano 2014 response criteria is higher than conventional chemotherapy. #Intervention - BIOLOGICAL : Pembrolizumab - 200 mg IV administered on Day 1 of each 3-week cycle for 3 cycles during pembrolizumab monotherapy. 400 mg IV administered on Day 1 of each 6-week cycle for 4 cycles as pembrolizumab consolidation. - Other Names : - MK-3475, SCH 900475, KEYTRUDA® - DRUG : Doxorubicin - 25 mg/m\^2 IV administered as part of AVD chemotherapy on Days 1 and 15 of each 4-week cycle for 2 cycles in all participants after PET scan 2 and up to 4 additional cycles after PET scan 3 (participants who are PET scan 3 negative, or positive and ≥60 years of age). 35 mg/m\^2 IV administered as part of escBEACOPP chemotherapy on Day 1 of each 3-week cycle for up to 4 cycles after PET scan 3 (participants who are PET scan 3 positive, \<60 years of age). - Other Names : - Adriamycin, DOXIL®, Rubex® - DRUG : Vinblastine - 6 mg/m\^2 IV administered as part of AVD chemotherapy on Days 1 and 15 of each 4-week cycle for 2 cycles after PET scan 2 (all participants) and up to 4 additional cycles after PET scan 3 (participants who are PET scan 3 negative, or positive and ≥60 years of age). - Other Names : - Alkaban-AQ®, Velban® - DRUG : Dacarbazine - 375 mg/m\^2 IV administered as part of AVD chemotherapy on Days 1 and 15 of each 4-week cycle for 2 cycles after PET scan 2 (all participants) and up to 4 additional cycles after PET scan 3 (participants who are PET scan 3 negative, or positive and ≥60 years of age). - Other Names : - Dtic-Dome® - DRUG : Bleomycin - 10 units/m\^2 IV administered as part of escBEACOPP chemotherapy on Day 8 of each 3-week cycle for up to 4 cycles after PET scan 3 (participants who are PET scan 3 positive and \<60 years of age). - Other Names : - Blenoxane® - DRUG : Etoposide - 200 mg/m\^2 IV administered as part of escBEACOPP chemotherapy on Days 1-3 of each 3-week cycle for up to 4 cycles after PET scan 3 (participants who are PET scan 3 positive and \<60 years of age). - Other Names : - Toposar®, VePesid®, Etopophos®, VP-16, Etoposide phosphate - DRUG : Cyclophosphamide - 1250 mg/m\^2 IV administered as part of escBEACOPP chemotherapy on Day 1 of each 3-week cycle for up to 4 cycles after PET scan 3 (participants who are PET scan 3 positive and \<60 years of age). - Other Names : - Neosar®, Cytoxan® - DRUG : Vincristine - 1.4 mg/m\^2 IV administered as part of escBEACOPP chemotherapy on Day 8 of each 3-week cycle for up to 4 cycles after PET scan 3 (participants who are PET scan 3 positive and \<60 years of age). - Other Names : - Oncovin®, Vincasar PFS® - DRUG : Procarbazine - 100 mg/m\^2 orally (PO) administered as part of escBEACOPP chemotherapy on Days 1-7 of each 3-week cycle for up to 4 cycles after PET scan 3 (participants who are PET scan 3 positive and \<60 years of age). - Other Names : - Matulane® - DRUG : Prednisone - 40 mg/m\^2 PO administered as part of escBEACOPP chemotherapy on Days 1-14 of each 3-week cycle for up to 4 cycles after PET scan 3 (participants who are PET scan 3 positive and \<60 years of age). - Other Names : - Liquid Pred®, Meticorten®, Orasone®, Deltasone®

#Eligibility Criteria: Inclusion Criteria: The main inclusion criteria include, but are not limited to the following: * Has a histologically confirmed diagnosis of Ann Arbor Stage III or IV classical Hodgkin Lymphoma (cHL). Stage I and II participants may be enrolled, but must have at least one National Comprehensive Cancer Network (NCCN) unfavorable risk factor per protocol * Has measurable 2-fluorodeoxyglucose (FDG)-avid disease based on investigator assessment according to Lugano 2014 response criteria * Has not received prior radiation therapy, chemotherapy, immunotherapy, or other systemic therapy for the treatment of cHL before the first dose of study intervention * Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 assessed within 7 days before the start of study intervention Exclusion Criteria: The main exclusion criteria include, but are not limited to the following: * Has confirmed nodular lymphocyte-predominant Hodgkin Lymphoma (HL) * Has an uncontrolled intercurrent cardiovascular illness * Has received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-programmed cell death ligand 1 protein (PD-L1), or anti- programmed cell death ligand 2 protein (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor * Has received or is expected to receive a live or live-attenuated vaccine within 30 days before the first dose of study intervention * Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication * Has a known additional malignancy that is progressing or has required active treatment within the past 5 years * Has radiographically detectable central nervous system metastases and/or carcinomatous meningitis * Has an active autoimmune disease that has required systemic treatment in past 2 years * Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease * Has a history or current evidence of pulmonary fibrosis * Has had an allogenic tissue/solid organ transplant ##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

{ "NCT_ID" : "NCT06337279", "Brief_Title" : "Systemic Oxidative Stress Score as a Predictor of Gastric Cancer Survival and Recurrence Risk", "Official_title" : "The Clinical Value of Systemic Oxidative Stress Score in Predicting Long-term Survival and Recurrence Risk in Gastric Cancer: A Multicenter Real-world Cohort Study", "Conditions" : ["Gastric Cancer"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary The Systemic Oxidative Stress Score (SOSS) , a comprehensive score reflecting the oxidative stress conditions in the microenvironment, can independently and effectively predict tumor burden and long-term prognosis in GC patients. Nomograms based on SOSS provide a potential and promising model for risk stratification and guiding the implementation of treatment decisions. Detailed Description We retrospectively analyzed the clinical data of gastric cancer patients who underwent radical gastrectomy in three hospitals from January 2009 to June 2020. The data from one hospital were randomly divided into a training cohort and an internal validation cohort in a 7:3 ratio, while the data from the other two centers were used as an external validation cohort. In the training cohort, COX proportional risk models were employed to identify key indicators of SOSS and independent prognostic factors influencing patients' OS and DFS. Subsequently, based on the results of the multifactor COX analysis, two predictive models for OS and DFS were developed. The predictive efficacy, calibration, and clinical utility of the models were evaluated using ROC curves, calibration curves, and decision curves in the internal and external validation cohorts, respectively. Both models demonstrated good discriminative ability between postoperative survival and recurrence risk, outperforming TNM staging in terms of predictive accuracy.

#Eligibility Criteria: Inclusion Criteria: 1) gastroscopic histopathological diagnosis of gastric adenocarcinoma; 2) radical gastrectomy for GC; 3) preoperative examination of oxidative indicators including Fbg, CHOL, ALB, TBIL, DBIL, and CR within seven days before surgery; and 4) the tumor did not invade neighboring organs or had no distant metastasis. Exclusion Criteria: 1) gastroscopic histopathological diagnosis of non-adenocarcinoma, 2) gastric stump cancer, 3) neoadjuvant chemotherapy, 4) other malignant diseases besides GC, 5) incomplete medical records, and 6) patients with GC lost to follow-up. ##Sex : ALL ##Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00702182", "Brief_Title" : "Study of Oral Vinorelbine and Erlotinib in Non-Small Cell Lung Cancer", "Official_title" : "Phase 1 Study of Oral Vinorelbine in Combination With Erlotinib in Advanced Non-Small Cell Lung Cancer (NSCLC) Using Two Different Schedules", "Conditions" : ["Non-Small Cell Lung Cancer"], "Interventions" : ["Drug: Erlotinib", "Drug: Vinorelbine (Navelbine)"], "Location_Countries" : ["Singapore"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to define the schedule and dose of oral vinorelbine (Navelbine) to be used with erlotinib in non-small cell lung cancer. Detailed Description Additive or supraadditive activity of an EGFR TK-I with vinorelbine has been demonstrated in-vitro. Clinical synergism has also been described between gefitinib and vinorelbine in NSCLC. The use of cytotoxics in a metronomic schedule has not been well investigated in the clinical setting despite emerging pre-clinical data. Using an established oral cytotoxic such as oral vinorelbine in a metronomic dose-schedule is attractive due to the oral route of administration. Preclinical studies have shown that by using cytotoxics in a low-dose protracted manner, endothelial cells are preferentially affected via inhibition of proliferation and induction of apoptosis. In addition to this anti-angiogenic mechanism, an anti-vasculogenic process may also be involved that acts by reducing circulating endothelial progenitor mobilization and viability. Moreover, it has also been shown that tumours that were selected for high levels of acquired resistance to cytotoxics can be induced to respond by using metronomic doses of chemotherapy. Continuous administration of metronomic oral vinorelbine, given three times a week, has been reported as feasible and well tolerated at doses up to 180 mg total dose per week. Early results showed activity against refractory solid tumors such as renal cancer, NSCLC, ovarian cancer, prostate cancer, unknown primary and Kaposi sarcoma. This phase I study combines erlotinib and oral vinorelbine on two different schedules. The conventional schedule vinorelbine (CSV) aims to determine the MTD of conventional schedule of oral vinorelbine given on days 1 and 8 every 21 days plus daily erlotinib and the metronomic schedule vinorelbine (MSV) aims to determine the optimal metronomic dose of vinorelbine given 3 times a week plus daily erlotinib. #Intervention - DRUG : Vinorelbine (Navelbine) - Conventional Schedule Oral Vinorelbine on day 1 and day 8 of a 21 day schedule - Other Names : - Navelbine - DRUG : Vinorelbine (Navelbine) - Metronomic Schedule Oral Vinorelbine 3 times a week - Other Names : - Navelbine - DRUG : Erlotinib - Daily Oral Erlotinib 100 mg - Other Names : - Tarceva

#Eligibility Criteria: Inclusion Criteria: * Histologically or cytologically confirmed NSCLC * At least one or two prior lines of chemotherapy for metastatic disease or locally advanced unresectable disease. There should be at least 4 weeks since prior chemotherapy or radiation therapy or 6 weeks if the last regimen included BCNU or mitomycin C * Age > 21 years. * ECOG performance status <2 (Karnofsky >60%, see Appendix A). * Life expectancy of greater than 3 months * Patients must have normal organ and marrow function as defined below: * leukocytes >3,000/mcL * absolute neutrophil count >1,500/mcL * platelets >100,000/mcL * total bilirubin within normal institutional limits * AST(SGOT)/ALT(SGPT) <2.5 X institutional ULN * creatinine within normal institutional limits OR * creatinine clearance >60 mL/min/1.73 m2 * The effects of Oral Vinorelbine on the developing human fetus are unknown. For this reason and because vinca alkaloids as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. * Patients may not be receiving any other investigational agents. * Patients who have received previous vinorelbine or oral EGFR tyrosine kinase inhibitors * Patients with progressive brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. However patients are eligible if they have brain metastases that have been treated with whole brain radiotherapy and are stable and not on corticosteroids. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to Oral Vinorelbine or other agents used in study. * Prior and / or concomitant treatment with drugs known to induce or inhibit cytochrome P450 3A4, CYP1A1 & CYP1A2 : phenytoin, carbamazepine, barbiturates, rifampicin, imidazole antifungals (such as ketoconazole, fluconazole, itraconazole, metronidazole), omeprazole and ritonavir * Significant malabsorption syndrome or disease affecting the gastro-intestinal tract function * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnancy or breast feeding or women of child-bearing potential not using effective contraception, * HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with Oral Vinorelbine. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated. * History of organ allograft * Patients with evidence or history of bleeding diatheses or coagulopathy * Serious, non-healing wound, ulcer, or bone fracture * Because of interaction risk on CYP3A4, patients with concomitant treatments with vitamin K antagonists such as phenprocoumon or warfarin or heparin or heparinoids should be excluded ##Sex : ALL ##Ages : - Minimum Age : 21 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02214602", "Brief_Title" : "Value of Immediate Post-operative Intravesical Epirubicin in Intermediate&High Risk Non Muscle Invasive Bladder Cancer", "Official_title" : "The Value of Immediate Post-operative Intravesical Epirubicin Instillation in Intermediate and High Risk Non Muscle Invasive Bladder Cancer (NMIBC): A Randomized Controlled Trial", "Conditions" : ["Carcinoma of Urinary Bladder, Superficial"], "Interventions" : ["Drug: Epirubicin"], "Location_Countries" : ["Egypt"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "SINGLE" } }

#Study Description Brief Summary The aim of the study is to test the value of immediate post-operative intravesical instillation of epirubicin in patients with intermediate and high risk non muscle invasive bladder cancer (NMIBC). Detailed Description Preoperative evaluation will be carried out in the form of routine laboratory investigations, abdominal and pelvic US and computed tomography (CT) or magnetic resonance imaging (MRI) abdomen and pelvis if necessary. Then, the patients will be subjected to complete TURBT. The patients will be transferred to the recovery room, careful monitoring of the patients will be carried out for the 1st 30 min, and then after confirming the patient eligibility for enrollment in the study by exclusion of cases with hematuria and suspicious bladder perforation, patients will be enrolled randomly into one of the two groups. The randomization process will be performed using computer-generated simple random tables in a 1:1 ratio or by the method of closed envelopes. The 1st group will not receive intravesical instillation of epirubicin -Placebo-(control group), and, the 2nd group will receive intravesical instillation of epirubicin 50 mg in 50 ml saline 0.9% (study group) with clamping of the urethral catheter for 1 hour after instillation and during this period the patients are monitored for local or systemic adverse events (acute abdomen, chills, fever, hot flushes, abdominal rigidity, hematuria after de-clamping of the catheter). Evaluation: Intraoperative and early postoperative parameters of interest will be recorded and compared between the two groups like EUA findings, tumor characteristics during cystoscopy as the tumor size, site, shape, number, suspicion of CIS, post instillation adverse events, cytology and biopsy results. The patients will be discharged after removal of urethral catheter. They will be stratified into either intermediate or high risk histopathologically confirmed NMIBC, followed up at the outpatient clinic (OPC) and will receive adjuvant intravesical instillation of chemotherapy or immunotherapy according to the European Association of Urology (EAU) guidelines for each risk group. The patients will be evaluated by office cystoscopy and urine cytology at the OPC after 12 weeks, and thereafter every 3 months during the first 2 years and then every 3 to 6 months according to the risk category. During the follow-up period, all histopathologically confirmed tumors will be classified as recurrences. Time to first recurrence will be the primary end point of the study, and the length of follow-up will be defined as the time from inclusion to the last cystoscopy control. Methods of evaluation and follow-up: All the patients will be evaluated on entry and at follow-up intervals. On study entry patients will be evaluated by urinalysis, urine culture, serum creatinine, fasting blood sugar level, complete blood count, chest X-ray, excretory urography (IVU) and or CT urography and bladder wash for cytology. CT with contrast will be performed annually in cases of high risk tumor category and when otherwise indicated. Complete TURBT of all visible tumors will be conducted in all patients and the stage and grade will be determined according to the 1987 staging classification and World Health Organization (WHO) grading system in 1973+ 2004 WHO grading system. #Intervention - DRUG : Epirubicin - Experimental: Study group(Epirubicin) in the arm -study group(Epirubicin)- : patients will receive immediate intravesical instillation of 50 mg of epirubicin in 50 ml of saline 0.9 % after 30 min after compete transurethral resection of bladder tumor - Other Names : - Intravesical chemotherapy, Doxorubicin

#Eligibility Criteria: Inclusion Criteria: * Ability to give informed consent. * Patients with primary or recurrent papillary Non muscle invasive bladder cancer (NMIBC). * Complete transurethral resection of bladder tumor(TURBT). * Normal cardiac, hematological, and renal functions. * Patients with intermediate and high risk NMIBC confirmed by histopathology. Exclusion Criteria: * Inability to give informed consent. * Patients with history of previous radiotherapy or systemic chemotherapy. * Patients suffering from immuno-deficiency or other malignancies. * Patients with history of hypersensitivity reaction to epirubicin. * Examination under anesthesia (EUA) reveals palpable bladder mass. * Patients with primary, single, less than 1cm papillary bladder tumor (high likelihood of being low risk). * Suspicion of perforation of the bladder during TURBT. * Patients who develop hematuria in the recovery room necessitating continuous bladder wash or endoscopic haemostasis. * Patients with proven low risk NMIBC on histopathology. ##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

{ "NCT_ID" : "NCT02548910", "Brief_Title" : "Phlebotomy to Prevent Blood Loss in Major Hepatic Resections", "Official_title" : "The PRICE Trial: Phlebotomy Resulting in Controlled Hypovolemia to Prevent Blood Loss in Major Hepatic Resections", "Conditions" : ["Liver Neoplasms", "Hepatectomy"], "Interventions" : ["Procedure: Phlebotomy", "Device: Citrated whole blood collection bag"], "Location_Countries" : ["Canada"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "TRIPLE" } }

#Study Description Brief Summary Major liver resection is associated with substantial intraoperative blood loss. Blood loss in elective liver surgery is a significant factor of perioperative morbidity and mortality, as well as possibly long-term oncologic outcome. The purpose of this study is to use whole blood phlebotomy to decrease the central venous pressure, resulting in a state of relative hypovolemia. It is hypothesized that this intervention will lead to a decrease in blood loss at the time of liver resection. Detailed Description Major liver resection is associated with significant intraoperative blood loss. Blood loss in elective liver surgery is a key determinant of perioperative morbidity and mortality, as well as possibly long-term oncologic outcome. Whole blood phlebotomy is a simple intervention, whose aim is to decrease the central venous pressure yielding a state of relative hypovolemia and thus lead to decreased blood loss. Small studies, mostly from the liver transplant literature, would suggest that phlebotomy with controlled hypovolemia can result in decreased blood loss and blood transfusion. Since blood loss is an important issue in liver surgery, and the benefits of phlebotomy and controlled hypovolemia are unknown in liver resection patients, a rigorously conducted trial in a representative population of patients undergoing liver resection is warranted, and feasible. In this proposal, it is hypothesized that by the use of phlebotomy and controlled hypovolemia, it is possible to decrease blood loss and blood transfusions. To test this hypothesis the investigators plan to randomly allocate participants to phlebotomy plus standard of care or to standard of care. Participants will be those patients undergoing elective major liver resection at the Ottawa Hospital for any indication. The primary outcome will be intraoperative blood loss. Secondary outcomes will include transfusion requirements, perioperative morbidity and mortality, safety, physiologic parameters, and feasibility elements. A total of 62 patients will be randomized. The efficacy of phlebotomy in terms of blood loss prevention will be assessed. #Intervention - PROCEDURE : Phlebotomy - A central venous catheter will be inserted for every patient to measure central venous pressure, as is the standard of care in elective liver surgery. Strict aseptic technique will be maintained. A total volume of whole blood of 7-10 mL per kg of body weight will be removed, as tolerated. The volume of removed blood will not be replaced by intravenous fluid administration. Collected blood will be transfused back at the end of the liver parenchymal transection, or within 8 hours of collection. - DEVICE : Citrated whole blood collection bag - Transfusion Medicine will send the requested number of whole blood collection bags labelled with the patient's name and MRN. These whole blood collection bags are used in standard practice for collection of whole blood.

#Eligibility Criteria: Inclusion Criteria: * Any patient being considered for a major elective liver resection will be considered for trial enrollment. Patients who are undergoing a concurrent additional abdominal or thoracic procedure (eg. colonic resection) will also be included. Exclusion Criteria: * Age <18 years * Pregnancy * Refusal of blood products * Active cardiac conditions: unstable coronary syndromes, decompensated heart failure (NYHA functional class IV; worsening or new-onset heart failure), significant arrhythmias, severe valvular disease * History of significant cerebrovascular disease * Renal dysfunction (patients with an estimated GFR <60 mL/min) * Abnormal coagulation parameters (INR >1.5 not on warfarin and/or platelets count <100 X109/L ) * Evidence of hepatic metabolic disorder (bilirubin >35 umol/L) * Presence of active infection * Preoperative autologous blood donation * Hemoglobin <100 g/L ##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

{ "NCT_ID" : "NCT00023933", "Brief_Title" : "Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Recurrent or Persistent Metastatic Colorectal Cancer", "Official_title" : "Phase I Trial of 131I-HuCC49^CH2 for Colon Cancer", "Conditions" : ["Adenocarcinoma of the Colon", "Adenocarcinoma of the Rectum", "Recurrent Colon Cancer", "Recurrent Rectal Cancer", "Stage IV Colon Cancer", "Stage IV Rectal Cancer"], "Interventions" : ["Drug: iodine I 131 monoclonal antibody CC49-deltaCH2"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy in treating patients who have recurrent or persistent metastatic colorectal cancer. Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. Radiolabeled monoclonal antibody therapy may be effective treatment for colorectal cancer Detailed Description PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose of iodine I 131 monoclonal antibody CC49-deltaCH2 (deleted CH2 region) in patients with colorectal cancer. II. Determine the toxic effects, plasma pharmacokinetics, whole body biodistribution, and conjugate stability of this drug in these patients. III. Determine the ability of this drug to localize to tumor sites in these patients. IV. Determine the immune response in patients treated with this drug. OUTLINE: This is a dose-escalation study. Patients receive a tracer dose of iodine I 131 monoclonal antibody CC49-deltaCH2 IV on day 1 and a therapy dose over 30 minutes on day 8. Cohorts of 3-5 patients receive escalating doses of iodine I 131 monoclonal antibody CC49-deltaCH2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 3 of 5 patients experience grade 3 or greater toxicity while 0-2 of 5 patients experience reversible grade 4 hematologic toxicity. Patients are followed weekly for a minimum of 7 weeks and then every 6 weeks until disease progression. #Intervention - DRUG : iodine I 131 monoclonal antibody CC49-deltaCH2 - Given IV - Other Names : - 131I-HuCC49-deltaCH2, 131I-MOAB CC49-deltaCH2

#Eligibility Criteria: Inclusion Criteria: * Histologically confirmed metastatic adenocarcinoma of the colon or rectum * Not amenable to surgical resection * Recurrent or persistent disease after standard surgery, radiotherapy, and chemotherapy, including fluorouracil and irinotecan * TAG-72 positive * Performance status - ECOG 0 <= age <= 2 * WBC greater than 3,500/mm^3 * Platelet count greater than 125,000/mm^3 * Hemoglobin greater than 10 g/dL * No nucleated RBC or significant teardrop RBC morphology * Bilirubin less than 1.5 mg/dL * SGOT/SGPT less than 4 times normal * Hepatitis B surface antigen negative * Creatinine less than 2.0 mg/dL * HIV negative * No other malignancy within the past 5 years except basal cell skin cancer * No allergy to iodine * No detectable antibody to monoclonal antibody CC49 * Not pregnant or nursing * Fertile patients must use effective contraception * At least 3 weeks since prior immunotherapy and recovered * No prior bone marrow or stem cell transplantation * No other concurrent immunotherapy * See Disease Characteristics * At least 3 weeks since prior chemotherapy and recovered * No concurrent chemotherapy * See Disease Characteristics * At least 3 weeks since prior radiotherapy and recovered * No prior radiotherapy to more than 25% of red marrow * No concurrent radiotherapy * See Disease Characteristics * At least 3 weeks since prior surgery and recovered ##Sex : ALL ##Ages : - Minimum Age : 19 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT04211766", "Brief_Title" : "Fiber and Fish Oil Supplements for the Prevention of Colorectal Cancer", "Official_title" : "Diet and the Colonic Exfoliome: A Novel, Non-Invasive Approach to Testing Interventions in Humans", "Conditions" : ["Healthy Subject"], "Interventions" : ["Other: Comparator", "Dietary Supplement: Fish Oil", "Dietary Supplement: Dietary Fiber"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional Model" : "CROSSOVER", "Masking" : "DOUBLE" } }

#Study Description Brief Summary This trial studies how fiber and fish oil supplements affect the metabolism and activities of colon cells in healthy individuals. Diet is an important risk factor for colorectal cancer, and several dietary components important in colorectal cancer prevention are modified by gut microbial metabolism. Giving fiber and fish oil supplements may inhibit the growth of gut cells and ultimately reduce risk of colorectal cancer. Detailed Description Participants are randomized to receive two dietary interventions in assigned random order. They either receive the dietary fiber supplement and fish oil supplement orally (PO) daily or they receive a fiber control and corn oil supplement daily for 30 days during the first intervention period. Then they enter a washout period for 60 days when they do not receive any treatment. After that they complete the second intervention period during which they receive the other intervention. #Intervention - DIETARY_SUPPLEMENT : Dietary Fiber - Given fiber supplement - Other Names : - Fiber - DIETARY_SUPPLEMENT : Fish Oil - Given fish oil supplement - Other Names : - Oil, Fish, Seafood Oil - OTHER : Comparator - Given fiber supplement placebo - Other Names : - placebo therapy, PLCB, sham therapy - OTHER : Comparator - Given fish oil supplement placebo (corn oil) - Other Names : - placebo therapy, PLCB, sham therapy

#Eligibility Criteria: Inclusion Criteria: * Healthy * Normal-overweight (body mass index [BMI] of 18 <= age <= 30 kg/m^2) * Women will be postmenopausal, with no menstrual period in 12 months * Non-smoking * Consume fiber intakes of less than < 20 g/d * White blood cell count 3,000 <= age <= 11,000/mm^3 * Platelet count 100,000 <= age <= 400,000 mm^3 * Hematocrit 33 <= age <= 50% (women); 36 <= age <= 50% (men) * Bilirubin 0.2 <= age <= 1.3 mg/dL * Aspartate aminotransferase (AST) 0 <= age <= 35 U/L * Alanine aminotransferase (ALT) 0 <= age <= 40 U/L * Alkaline phosphatase 20 <= age <= 125 U/L * Creatinine =< 1.2 mg/dL * Potassium 3.5 <= age <= 5.0 mmol/L Exclusion Criteria: * Chronic medical illness, history of gastrointestinal disorders (e.g., ulcerative colitis, Crohn disease, celiac sprue, hereditary nonpolyposis colorectal cancer [HNPCC], familial adenomatous polyposis, pancreatic disease, previous gastrointestinal resection, radiation or chemotherapy, and cancer (other than non-melanoma skin cancer) * Weight change greater than 4.5 kg within past year * Oral or intravenous (IV) antibiotic use within the past 3 months * Regular use of aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) * Smoking or use of cannabis products * Known allergy to fish * Intention to relocate out of study area within next 4 months ##Sex : ALL ##Ages : - Minimum Age : 50 Years - Maximum Age : 75 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: Yes

{ "NCT_ID" : "NCT00084877", "Brief_Title" : "Irinotecan and 3-AP in Treating Patients With Metastatic or Unresectable Solid Tumors", "Official_title" : "A Phase I Study of Triapine® in Combination With Irinotecan in Refractory Tumors", "Conditions" : ["Unspecified Adult Solid Tumor, Protocol Specific"], "Interventions" : ["Drug: triapine", "Other: laboratory biomarker analysis", "Other: pharmacological study", "Drug: irinotecan hydrochloride"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This phase I trial is studying the side effects and best dose of irinotecan and 3-AP in treating patients with metastatic or unresectable solid tumors. Drugs used in chemotherapy such as irinotecan work in different ways to stop tumor cells from dividing so they stop growing or die. 3-AP may stop the growth of tumor cells by blocking the enzymes necessary for their growth and may help irinotecan kill more tumor cells by making them more sensitive to the drug. Detailed Description PRIMARY OBJECTIVES: I. To find the maximal tolerated dose for the combination of irinotecan and Triapine® in patients with refractory solid tumors. SECONDARY OBJECTIVES: I. To find the severity and frequency of toxicity associated with this combination and to observe for and record any antitumor activity. TERTIARY OBJECTIVES: I. To evaluate the effect of Triapine®/irinotecan on the ribonucleotide reductase tyrosyl radical in vivo by Electron Paramagnetic Spectroscopy (EPR) in buccal mucosal cells, peripheral blood lymphocytes and in tumor biopsies. Formation of low molecular weight iron-Triapine® chelates will also be assessed by EPR. II. To evaluate the effect of Triapine® /irinotecan on cell cycle in vivo by measuring S-phase arrest in buccal mucosal cells. III. To evaluate the effect of Triapine® /irinotecan on MDR gene expression and polymorphisms in blood. IV. To evaluate the effect of Triapine® /irinotecan on ribonucleotide reductase R2 mRNA and Immunohistochemistry. V. To evaluate the pharmacokinetic profile of the combination. OUTLINE: This is a dose-escalation study. Patients receive irinotecan IV over 1 hour on day 1 and 3-AP (Triapine®) IV over 2 hours on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of irinotecan and 3-AP (Triapine®) until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 6 additional patients are treated at that dose. Patients are followed until disease progression. #Intervention - DRUG : triapine - Given IV - Other Names : - 3-AP, OCX-191 - DRUG : irinotecan hydrochloride - Given IV - Other Names : - Campto, Camptosar, CPT-11, irinotecan, U-101440E - OTHER : laboratory biomarker analysis - Correlative studies - OTHER : pharmacological study - Correlative studies - Other Names : - pharmacological studies

#Eligibility Criteria: Inclusion Criteria: * Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative chemotherapy measures do not exist or are no longer effective * Patients must not have previously received irinotecan * Patients must not have received radiation to > 25% of bone marrow * ECOG performance status =< 2 * Life expectancy of greater than 12 weeks * Leukocytes >= 3,000/μl * Absolute neutrophil count >= 1,500/μl * Platelets >= 100,000/μl * Total bilirubin within normal institutional limits * AST(SGOT)/ALT(SGPT) =< 2.5 X institutional upper limit of normal * Creatinine =< 1.5 mg/dl OR creatinine clearance >= 50 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal * Patients must have measurable or evaluable disease * Patients must have baseline screening for G6PD (glucose-6-phosphate dehydrogenase) deficiency; G6PD must be no lower than the lower limit of normal prior to starting study treatment; patients who are above the upper limit of normal may enroll in the trial * The effects of Triapine® on the developing human fetus are unknown; for this reason and because heterocyclic carboxaldehyde thiosemicarbazones as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * Ability to understand and the willingness to sign a written informed consent document * Patients must have a baseline screening test for UGT1A1; the UGT1A1 cannot be the 7/7 genotype; patients who have any other combinations (6/6, 6/7, 5/7, etc.) may enroll in the trial Exclusion Criteria: * Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study * Patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier; patients with grade 1 adverse events from prior therapies are eligible at the investigator's discretion * Patients may not be receiving any other investigational agents * History of allergic reactions attributed to compounds of similar chemical or biologic composition to Triapine® or other agents used in study * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant women are excluded from this study because Triapine® is a heterocyclic carboxaldehyde thiosemicarbazone with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Triapine®, breastfeeding should be discontinued if the mother is treated with Triapine®; these potential risks may also apply to other agents used in this study * Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy; therefore, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with Triapine® or other agents administered during the study; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated * Patients with known G6PD deficiency are excluded * Patients with a history of myocardial infarction or severe pulmonary disease requiring oxygen are excluded * Because of the potential for enzyme-inducing anticonvulsant agents (EIACAs) to alter the metabolism and pharmacokinetics of irinotecan, patients who are taking EIACAs are excluded * Metastatic brain or meningeal tumors unless the subject is > 6 months from definitive therapy, had a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry; also the patient must not be undergoing acute steroid therapy or taper * Patients with UGT1A1 7/7 genotype are excluded ##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

{ "NCT_ID" : "NCT00056537", "Brief_Title" : "ABR-217620 in Patients With Advanced Non-Small Cell Lung Cancer, Renal Clear Cell Carcinoma or Pancreatic Cancer", "Official_title" : "An Open-Label, Phase I, Repeat Dose-Escalation Study of ABR-217620 in Patients With Advanced Non-Small Cell Lung Cancer, Renal Clear Cell Carcinoma or Pancreatic Cancer", "Conditions" : ["Non-Small-Cell Lung Carcinoma", "Renal Cell Carcinoma", "Pancreatic Cancer"], "Interventions" : ["Drug: ABR-217620"], "Location_Countries" : ["United States", "United Kingdom", "Norway"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The drug ABR-217620 is a combination of two proteins, one that recognizes tumor cells and one that triggers an attack on the tumor cells by activating some white blood cells belonging to the body's normal immune system. In animals, this results in an accumulation of white blood cells in the cancer that can fight the cancer. This study will test how much of the drug can be given to patients with non-small cell lung cancer, renal clear cell carcinoma, or pancreatic cancer without causing unacceptable side effects. #Intervention - DRUG : ABR-217620 - Starting dose: 0.5 mcg/kg; subsequent doses: individual, based on pre-treatment level of anti-SEA/E-120, body weight, and toxicities observed in prior patients on study; IV; one bolus injection each day for 5 consecutive days; up to 3 cycles - Other Names : - CD3; 5T4FabV18-SEA/E-120; naptumomab estafenatox; Anyara

#Eligibility Criteria: Inclusion Criteria: * Patients with histologically or cytologically confirmed non-small cell lung cancer, which is refractory to (progressed on or following) currently available standard therapies. Patients must have received (or declined) at least one standard regimen for advanced/metastatic disease. * ECOG performance status of 0 or 1. * Adequate bone marrow function as defined by absolute neutrophil count greater than or equal to 1500/mm3, and platelets greater than or equal to 100,000/mm3, and hemoglobin greater than or equal to 10 g/dL. * Adequate renal function: creatinine less than or equal to 1.5 x upper limit of normal. * Adequate hepatic function: bilirubin less than or equal to 2 x upper limit of normal, and SGOT (S-ASAT) and SGPT (S-ALAT) less than or equal to 2.5 x upper limit of normal. * Life expectancy greater than 3 months. Exclusion Criteria: * Pregnant or breast-feeding women, or women of childbearing potential unless effective methods of contraception are used. * A serious uncontrolled medical disorder or active infection that would impair the patient's ability to receive study treatment. * History of or any concurrent malignancy, with the exception of the following malignancies, which may still be included: non-melanoma skin cancer, cervical cancer in situ, DCIS or LCIS of breast, past history of resected melanoma without clinical evidence of recurrent melanoma, past history of prostate cancer without clinical evidence of disease (includes patients receiving hormonal therapy). * History of brain metastases, unless stable for more than 4 weeks, and not requiring steroid therapy and without clinical symptoms of brain metastases. * Acute illness or evidence of infection, including unexplained fever (temperature greater than 100.5 degrees Fahrenheit or 38.1 degrees Celsius). * Significant symptomatic cardiac disease including: history (within the past 6 months) or current unstable angina, congestive heart failure, or myocardial infarction; or patients with uncontrolled hypertension, or hypertension that is controlled only with multiply drugs (control by monotherapy is permitted). * History of or current arrhythmias requiring treatment, with the exception of non-specific, asymptomatic ST-T wave changes or extrasystoles. * History of cerebrovascular accident within the past 5 years. * Seizure disorder requiring therapy. * Treatment with beta-blockers, including topical therapy for glaucoma, during the 6-day treatment period (5 days' treatment + 1 day in patient follow-up), and within five days prior to start of treatment. * Simultaneous participation in any other study involving investigational drugs or having participated in a study less than 4 weeks prior to start of study treatment. * Treatment with systemic or inhaled corticosteroids within 2 weeks prior to the start of treatment. * Treatment with anticoagulants, except when used to maintain the patency of a central venous line. * Active autoimmune disease requiring therapy or any history of systemic lupus erythematosus or rheumatoid arthritis. * Chemo/radio/immunotherapy less than 4 weeks (6 weeks for mitomycin C and nitrosoureas) before start of treatment. * Major surgery less than 3 weeks. * Known positive serology for HIV (patients with a known history of HIV will be excluded because of potential for unforeseen toxicity and morbidity in the immunocompromised host). * Known chronic Hepatitis B or C. * Previous exposure to murine monoclonal antibody (with HAMA titer above detection limit at baseline) or known hypersensitivity to murine proteins. * Patients currently on renal dialysis treatment. * Known allergy or hypersensitivity to aminoglycosides e.g. kanamycin. ##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

{ "NCT_ID" : "NCT04396886", "Brief_Title" : "Bintrafusp Alfa in Previously Treated Patients With R/M Non-keratinizing NPC", "Official_title" : "Phase II Prospective Study of Bintrafusp Alfa in Previously Treated Patients With Recurrent and Metastatic (R/M) Non-keratinizing Nasopharyngeal Carcinoma (NPC)", "Conditions" : ["Nasopharyngeal Carcinoma", "Recurrent Carcinoma", "Metastatic Cancer", "Non-keratinizing Carinoma"], "Interventions" : ["Drug: Bintrafusp Alfa"], "Location_Countries" : ["Hong Kong"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This would be a phase II prospective single arm mono-institutional study conducted in Queen Mary Hospital (Hong Kong) assessing the efficacy and safety of bintrafusp alfa in previously treated patients with recurrent and metastatic (R/M) non-keratinizing nasopharyngeal carcinoma (NPC). Detailed Description All the patients must be registered with the Investigator(s) prior to initiation of treatment. The registration desk will confirm all eligibility criteria and obtain essential information (including patient number). Patients shall receive Bintrafusp alfa treatment through intravenous therapy every two weeks up until disease progression, unacceptable toxicity or for a maximum of 2 years. Survival Follow-up till 2 years will also be performed. #Intervention - DRUG : Bintrafusp Alfa - Bintrafusp alfa will be administered intravenously every 2 weeks

#Eligibility Criteria: Inclusion Criteria: * Histologically or cytologically confirmed non-keratinizing differentiated (World Health Organization WHO Type II) or undifferentiated (WHO Type III) nasopharyngeal carcinoma (NPC) that has recurred at regional or / and distant sites * Measurable disease according to the RECIST criteria (version 1.1) for the evaluation of measurable disease * Received one or more lines of chemotherapy, which must include prior treatment with a platinum agent either for the treatment of metastatic or recurrent disease * Experienced progression of disease within 6 months following completion of a platinum-based combination therapy as part of (neo)-adjuvant therapy * Male or female subjects with age: 18 <= age <= 79 years * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 * No prior immunotherapy * Written informed consent obtained for clinical trial participation and providing archival tumor tissue, if available * Females of childbearing potential or non-sterilized male who are sexually active must use a highly effective method of contraception * Females of childbearing potential must have negative serum or urine pregnancy test * Have life expectancy >= 3 months * Adequate organ function as defined as: Absolute neutrophil count >= 1.5 x 10^9/L, Platelet count >= 100 x 10^9/L, Hemoglobin >= 8.0 g/dL, Serum alanine aminotransferase ([ALT]; serum glutamate-pyruvate transferase [SGPT]), or serum aspartate aminotransferase [AST] where available at the center) < 2.5 x upper limit of normal (ULN), OR < 5 x ULN in the presence of liver metastases * Serum total bilirubin < 2 x ULN * Serum creatinine < 1.5 x ULN Exclusion Criteria: * Prior invasive malignancy within 2 years except for non-invasive malignancies such as cervical carcinoma in situ, in situ prostate cancer, non-melanomatous carcinoma of the skin, lobular or ductal carcinoma in situ of the breast that has been surgically cured * Isolated local recurrence or persistent disease * Has disease that is suitable for local therapy administrated with curative intent * Severe, active co-morbidity * Currently participating in and receiving clinical trial treatment or has participated in a trial of an investigational agent and received study treatment or used an investigational device within 4 weeks of the first dose of treatment * Has prior chemotherapy, targeted therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (<= grade 1 or at baseline) from adverse events due to previous administered agent * Untreated active central nervous system (CNS) metastatic disease, lepto-meningeal disease, or cord compression * Clinically significant (active) cardiovascular disease: cerebral vascular accident/stroke (<6 months prior to enrollment), myocardial infarction (<6 months prior to enrollment), unstable angina, congestive heart failure (>=New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication. * Prior treatment with any other anti-programmed cell death protein-1 (anti-PD-1), or PD Ligand-1 (PD-L1) or PD Ligand-2 (PD-L2) agent or an antibody targeting other immuno-regulatory receptors or mechanisms * Irritable bowel syndrome or other serious gastrointestinal chronic conditions associated with diarrhea within the past 3 years prior to the start of treatment * Known history of testing positive for HIV or known acquired immunodeficiency syndrome. * On chronic systemic steroid or any other forms of immunosuppressive medication within 14 days prior to the treatment. Except: Intra-nasal, inhaled, topical steroids, or local steroid injection (e.g., intraarticular injection); Systemic corticosteroids at physiologic doses <=10 mg/day of prednisone or equivalent; Steroids as premedication for hypersensitivity reactions due to bintrafusp alfa * Active or prior documented autoimmune or inflammatory disorders in the past 2 years, except diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment * Known active hepatitis B or known hepatitis C is detected; subjects who have been treated and now have an undetectable viral load are eligible * History of primary immunodeficiency or solid organ transplantation * Receipt of live, attenuated vaccine within 28 days prior to the study treatment * Active infection requiring systemic therapy * Severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb) * Females who are pregnant, lactating, or intend to become pregnant during their participation in the study * Psychiatric disorders and substance (drug/alcohol) abuse ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Maximum Age : 79 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00344552", "Brief_Title" : "Phase II Study of Weekly Paclitaxel (BMS-181339)in Patients With Advanced or Recurrent Esophageal Cancer", "Official_title" : "Phase II Study to Evaluate Efficacy and Safety of Weekly Paclitaxel (BMS-181339)in Patients With Advanced or Recurrent Esophageal Cancer. This Study is an Extension Study for Japanese Registration Only.", "Conditions" : ["Esophageal Cancer"], "Interventions" : ["Drug: Paclitaxel"], "Location_Countries" : ["Japan"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this clinical research study is to learn if BMS-181339 can shrink or slow the growth of the cancer in patients with advanced or recurrent esophageal cancer. The safety of this treatment will also be studied. #Intervention - DRUG : Paclitaxel - Injection solution, IV, 100mg/sqm, once weekly, 7 weeks and over - Other Names : - Taxol

#Eligibility Criteria: Inclusion Criteria: * Patients must have measurable disease * Patients must have experienced on pervious chemotherapy regime * Men and Women, with the age >= 20 years * ECOG PS: 0 <= age <= 1 Exclusion Criteria: * Patients with previous therapy with Taxanes ##Sex : ALL ##Ages : - Minimum Age : 20 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03394222", "Brief_Title" : "Effect of Preoperative Budesonide Inhalation on Arterial Blood Oxygenation and Intrapulmonary Shunt During OLV", "Official_title" : "Effect of Preoperative Budesonide Inhalation on Arterial Blood Oxygenation and Intrapulmonary Shunt in Patients Received One-lung Ventilation", "Conditions" : ["Lung Cancer"], "Interventions" : ["Drug: preoperative normal saline inhalation", "Drug: preoperative budesonide inhalation"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "DOUBLE" } }

#Study Description Brief Summary The purpose of this study is to conduct a randomized controlled trial to evaluate the effect of preoperative budesonide inhalation on arterial blood oxygenation and intrapulmonary shunt in patients received one-lung ventilation Detailed Description Population: The target population comprises all adult aged 45-65 years who was diagnosed lung cancer and to receive video-assist thoracoscopic lobectomy under general anethesia.The study sample will include 50 subjects of both gender and any race or ethnicity. Procedures: Eligible and consented patients will be enrolled into the study if all eligibility criteria are met and will be randomly allocated to one of the two study arms:Budesonide inhalation group vs Normal saline inhalation group Study Duration: Overall duration of the study is 10 months. #Intervention - DRUG : preoperative budesonide inhalation - DRUG : preoperative normal saline inhalation

#Eligibility Criteria: Inclusion Criteria: * Aged 45 yr to 65 yr ,height 155 <= age <= 176cm,weight 45 <= age <= 75kg,body mass index(BMI)18 <= age <= 27kg/m2,ASA Physical Status Classifications I to II,left-lateral position during OLV ,normal cardiac and pulmonary function ,and no cardiac,hepatic,renal and endocrine diseases.Diagnosed with uncomplicated lung cancer and was to receive video-assist thoracoscopic lobectomy under general anesthesia. Exclusion Criteria: * FEV1/FVC<70%,asthma,chronic obstructive pulmonary disease,acute lung infection,past history of thoracic surgery. preoperative glucocorticoid medication,preoperative chemotherapy,SpO2 kept below 90% for more than 15 minutes during operation,blood transfusion during operation,OLV less than an hour,occurrence of severe complications like allergic shock. ##Sex : ALL ##Ages : - Minimum Age : 45 Years - Maximum Age : 65 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01834742", "Brief_Title" : "Pharmacodynamic Evaluation of Stool Output Following Oral Administration of Various Low Volume PEG3350-based Gut Cleansing Solutions Using the Split Dose Intake in Healthy Subjects", "Official_title" : "Pharmacodynamic Evaluation of Stool Output Following Oral Administration of Various Low Volume PEG3350-based Gut Cleansing Solutions Using the Split Dose Intake in Healthy Subjects", "Conditions" : ["Colorectal Cancer"], "Interventions" : ["Drug: NER1006", "Drug: Moviprep"], "Location_Countries" : ["Romania"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This study is to investigate the effect of various modified low volume polyethylene glycol (PEG) 3350 and ascorbic acid/ascorbate (PEG+ASC)-based gut cleansing solutions on stool output in healthy subjects. In addition, the study is to assess and compare the safety and tolerance of the modified PEG+ASC formulations following oral administration with the safety profile of MOVIPREP®. #Intervention - DRUG : NER1006 - Single evening dose of 750mL solution containing 100g PEG3350 plus 6g sodium sulphate. Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid. - DRUG : NER1006 - Single evening dose of 750mL solution containing 100g PEG3350 plus 9g sodium sulphate. Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid. - DRUG : NER1006 - Single evening dose of 750mL solution containing 75g PEG3350 plus 5.6g sodium sulphate. Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid. - DRUG : Moviprep - Reconstituted and administered in accordance with recommended split dose intake: one litre in the evening, one litre the following morning. - DRUG : NER1006 - Single evening dose containing formulation selected from Part A of study. Single morning dose containing 40g PEG3350 and 56.6g sodium ascorbate. - DRUG : NER1006 - Single evening dose containing formulation selected from Part A of study. Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate and 21.4g magnesium ascorbate. - DRUG : NER1006 - Single evening dose containing formulation selected from Part A of study. Single morning dose containing 40g PEG3350, 6g sodium sulphate and 33.9g sodium ascorbate. - DRUG : NER1006 - Single evening dose containing formulation selected from Part A of study. Single morning dose containing 29g PEG3350 and 4.8g sulphate and 23.3g ascorbic acid.

#Eligibility Criteria: Inclusion Criteria: * The subject's written informed consent must be obtained prior to inclusion. * Healthy subjects with an age of 18 <= age <= 45. * Healthy subjects need to be without any history of clinical significant gastrointestinal symptoms by clinical judgement and without the presence of acute abdominal discomfort or symptoms. * Females must be surgically sterile, practicing true sexual abstinence or using an acceptable form of effective contraception throughout the study from the following list: contraceptive implants, injectables, oral contraceptives, intrauterine system (IUS), some intrauterine devices (IUDs), vasectomised partner or barrier method (condom or occlusive cap) with spermicidal foam/gel/film/cream/suppository. Hormonal and IUD methods of contraception must be established for a period of 3 months prior to dosing and cannot be changed or altered during the study. All females must have a negative pregnancy test at screening and check-in. * Willing, able and competent to complete the entire procedure and to comply with study instructions. Exclusion Criteria: * Use of laxatives in the last 12 months or colon motility altering drugs in the last 6 months. * Use of any prescription or over-the-counter (OTC) medication within 4 weeks prior to the first dose of investigational drug (excluding hormonal contraception, and occasional use of nonsteroidal anti-inflammatory drugs [NSAID], acetaminophen or metamizole). * Donation or loss of 500 mL or more of blood within 8 weeks prior to the first dose of investigational drug. * Any evidence of the history or presence of organic or functional gastrointestinal conditions (e.g. chronic constipation, irritable bowel syndrome [IBS], inflammatory bowel disease [IBD]). * Exhibiting relevant abnormal gastrointestinal motility according to clinical judgement in the past or now. * History or presence of any clinically significant acute illness within the 4 weeks prior to the first dose of investigational drug based on clinical judgement at screening and check-in evaluation. * Known glucose-6-phosphatase dehydrogenase deficiency. * Known phenylketonuria. * History or evidence of any clinical significant systemic cardiovascular, hepatic, pulmonal, neurological, metabolic and/or renal organ dysfunction. * History of clinically significant drug allergy; history of atopic allergy (asthma, urticaria, eczematous dermatitis), known hypersensitivity to polyethylene glycols and/or ascorbic acid. * History or evidence of any clinically relevant electrocardiogram (ECG) abnormalities and hypertension. * Evidence of dehydration. * Any evidence for abnormal sodium or potassium levels or clinically significant other electrolyte disturbances. * Females who are pregnant, having a positive pregnancy test at screening and/or admission to unit or planning a pregnancy. Females not using reliable methods of birth control. * Clinically relevant findings on physical examination based on Investigator's judgement. * Clinically relevant deviations of laboratory parameters from reference ranges at screening or check-in evaluation. * Positive serology for chronic viral hepatitis or human immunodeficiency virus (HIV) at screening. * History of drug or alcohol abuse within the 12 months prior to dosing or evidence of such abuse as indicated by the laboratory assays conducted during the screening or check-in evaluations. * Subjects who are unwilling to comply with the provisions of the study protocol. * Concurrent participation in an investigational drug study or participation within 3 month of study entry. * Subject has a condition or is in a situation, which in the Investigators opinion may put the subject at significant risk, may confound the study results, or may interfere significantly. * Previous participation in the study. ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Maximum Age : 45 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT ##Accepts Healthy Volunteers: Yes

{ "NCT_ID" : "NCT00739141", "Brief_Title" : "Conditioning Regimen and the Transplantation of Unrelated Donor Umbilical Cord Blood in Patients With Hematologic Malignancies.", "Official_title" : "A Reduced Intensity Conditioning Regimen and the Transplantation of Unrelated Donor Umbilical Cord Blood in Patients With Hematologic Malignancies.", "Conditions" : ["Leukemia", "Myelodysplastic Syndrome", "Non-Hodgkins Lymphoma", "Chronic Myelogenous Leukemia", "Hodgkins Lymphoma"], "Interventions" : ["Drug: fludarabine, cyclophosphamide, thiotepa, radiation therapy, unrelated donor umbilical cord blood graft"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The traditional way of doing a donor transplant is to give high doses of chemotherapy and radiation before giving the stem cells. However, high doses of chemotherapy and radiation can have serious side-effects. The doctors think that the transplant will be safer and more likely to be successful with reduced doses of chemotherapy and radiation. The purpose of this study is to find out how good a combination of chemotherapy and radiation at reduced doses followed by a cord blood transplant are at treating cancer. The stem cells chosen for the transplant are from umbilical cord blood. Umbilical cord blood is collected from healthy newborn babies and frozen. One cord blood collection is called a 'cord blood unit.' On transplant day, the cord blood will be given through the catheter just like a blood transfusion. Transplants done this way have been successful. However, this type of transplant is fairly new. Therefore, it is important to study it so the doctors can better understand how it works. Most blood or bone marrow transplants using donor stem cells are done as part of a study. When patients are on a study we test new ways of treating them which we think may be better than the old ways. We collect information about the result of this treatment so we can understand how well the treatment works. This is so we can learn better ways to treat our patients. #Intervention - DRUG : fludarabine, cyclophosphamide, thiotepa, radiation therapy, unrelated donor umbilical cord blood graft - Cyclophosphamide 50 mg/kg/dose x 1 IV day -6 (1 dose) Fludarabine 30 mg/m2/dose x 5 IV days -6 to -2 (5 doses) Thiotepa 5 mg/kg/dose x 2 IV days -5 to -4 (2 doses) TBI 200 cGy/dose x 2 days -2 to -1 (2 doses). On transplant day, the cord blood cells will be given through your catheter. The immune suppressing drugs you will receive are called cyclosporine-A (CSA) and mycophenolate mofetil (MMF). These will be started 3 days before the transplant and will be given through your catheter. Later they can be given as tablets.

#Eligibility Criteria: Inclusion Criteria: * At least one cycle of induction or re-induction chemotherapy or lymphoma chemotherapy or azacitidine or decitabine or tyrosine kinase inhibitor. * Patients aged 18 <= age <= 70 years at initial referral with no available and suitably matched related or unrelated donor. * Acute myelogenous leukemia (AML): * Complete first remission (CR1) at high risk for relapse such as: * Known prior diagnosis of myelodysplasia (MDS) or myeloproliferative disorder; * Therapy related AML; * White cell count at presentation > 100,000; * Presence of extramedullary leukemia at diagnosis; * Any unfavorable sub type by FAB or WHO classification; * High-risk cytogenetics (eg those associated with MDS, abnormalities of 5, 7, 8, Philadelphia chromosome, complex karyotype)or high risk molecular abnormalities; * Requirement for 2 or more inductions to achieve CR1. * Any patient with newly diagnosed AML with intermediate risk cytogenetics. * Any patient unable to tolerate consolidation chemotherapy as would have been deemed appropriate by the treating physician. * Complete second remission (CR2). * Other acute leukemias that are ambiguous lineage or of other types eg blastic plasmacytoid dendritic cell neoplasm in CR1 or CR2 * Acute lymphoblastic leukemia (ALL): * lymphoblastic leukemia (ALL): * Complete first remission (CR1) at high risk for relapse such as: * White cell count at presentation > 30,000 for B-cell lineage and >100,000 for Tcell lineage; * Presence of a high-risk cytogenetic abnormality such as t(9;22), t(1;19), t(4;11) or other MLL rearrangements (11q23)or other high-risk molecular abnormality; * Failure to achieve complete remission after four weeks of induction therapy; * Any patient with newly diagnosed ALL > or = to 50 years-old; * Any patient unable to tolerate consolidation and/or maintenance chemotherapy as would have been deemed appropriate by the treating physician. * Complete second remission (CR2). * Myelodysplastic Syndrome (MDS): * Intermediate-1 International Prognostic Scoring System (IPSS) score with poor risk cytogenetics as defined by IPSS. * Intermediate- 2 or High International Prognostic Scoring System (IPSS) score. * MDS/ myeloproliferative disorder overlap syndromes. * Any score with life threatening cytopenia(s), including red cell or platelet transfusion dependence. * Receipt of at least one cycle of cytotoxic chemotherapy, azacitidine or decitabine. * MDS patients must have < or = to 5% bone marrow myeloblasts and ANC > or = to 0.2 (growth factor supported if necessary) at transplant work-up. * Myeloproliferative Disorder (MPD) * Life-threatening cytopenia(s), and/or red blood cell or platelet transfusion dependence * Patients with aplasia * Patients with excess blasts less than or equal to 10% blasts in the bone marrow at work-up. * Chronic myelogenous leukemia (CML) patients who have failed or are intolerant of tyrosine kinase inhibitors or patients with other myeloproliferative diseases who are high risk and the intent of therapy is cure. * Any Non-Hodgkins lymphoma (including chronic lymphocytic leukemia)or Hodgkin's lymphoma at high-risk of relapse * Eligible patients with DLC NHL will: have relapsed disease following initial therapy but failed to mobilize or had bone marrow involvement and therefore are not suitable for an autologous transplant OR * have failed an autologous transplant and be in CR after salvage chemotherapy. * Eligible patients with transformed indolent NHL/CLL will: have CR/PR of the large cell component of their disease after either salvage chemotherapy or an autologous transplant. * Eligible patients with mantle cell NHL will: be high-risk as such as p53 positivity and be in 1st CR/PR after initial therapy OR have relapsed disease following initial therapy and be in 2nd or 3rd CR/PR after salvage chemotherapy. * Eligible patients with indolent B cell NHL (such as, but not limited to, follicular, small cell or marginal zone NHL) or CLL will have 2nd or subsequent progression (pre-allograft cytoreduction necessary but CR/PR not required). * Eligible patients with HL will be without progression of disease (POD) after salvage chemotherapy. * Timing of UCBT: * Admission for UCBT must be within an acceptable time period after the pre-allograft chemotherapy. * Organ Function and Performance Status Criteria: * Karnofsky score > or = to 70 %. * calculated creatinine clearance > or = to 60 ml/min * bilirubin < than or = to 1.5 mg/dL, ALT < than or = to 3 x upper limit of normal unless benign congenital hyperbilirubinemia, * pulmonary function (spirometry and corrected DLCO) > or = to 50% predicted. * left ventricular ejection fraction > or = to 50%. * albumin > or = to 3.0. * Graft Criteria: * 2 UCB units selected according to current MSKCC unit selection algorithm. High resolution 8 allele HLA typing will be performed. Unit selection will occur based on 8 allele HLA-match and CD34+ dose. * In addition, each unit will have a cryopreserved dose of at least 1.5 x 10^7 total nucleated cells/recipient body weight (TNC/kg). * Units with attached segments for confirmatory typing will be given preference. Exclusion Criteria: * Diagnosis: acute leukemia in morphologic relapse or with morphologic persistent disease (cytogenetic or molecular persistence/relapse in morphologic CR are eligible); MDS or CML or other myeloproliferative disorder with > 5% blasts; Aggressive lymphoma or HL with POD after salvage chemotherapy. * Two prior stem cell transplants of any kind. * One prior autologous stem cell transplant within the preceding 12 months. * One prior allogeneic stem cell transplant within the preceding 24 months. * Prior radiation therapy with 400cGy or more of TBI. * Active and uncontrolled infection at time of transplantation. * HIV infection. * Seropositivity for HTLV-1. * Inadequate performance status/ organ function. * Pregnancy or breast feeding. * Patient or guardian unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, follow-up, and research tests ##Sex : ALL ##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

{ "NCT_ID" : "NCT04932070", "Brief_Title" : "Berberine and Polycystic Ovary Syndrome", "Official_title" : "Berberine is an Effective Insulin Sensitizer and Improves Homeostasis of Metabolic and Hormonal Disorders in Women With Polycystic Ovary Syndrome: a Novel Treatment Strategy for PCOS", "Conditions" : ["Polycystic Ovary Syndrome", "Berberine"], "Interventions" : ["Dietary Supplement: Berberine"], "Location_Countries" : ["Italy"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Polycystic Ovary Syndrome (PCOS) is the most frequent endocrine disease in female reproductive-age. Recently, increasing evidence has shown that natural plant-based products may play a role in PCOS management. Previous study in PCOS preclinical model and in humans demonstrated that berberine is an effective insulin sensitizer and improves homeostasis of metabolic, inflammatory and hormonal disorders. However, to date there is no clinical study that considers globally all the activities carried out by berberine in PCOS clinical features. Given this background, aim of this study was to evaluate in normal-overweight PCOS women with normal menses the berberine effectiveness on: insulin resistance by Homeostasis Model Assessment (HOMA); inflammation by C-Reactive Protein (CRP), TNF-alpha; lipid metabolism; sex hormone profile and symptoms correlated to hyperandrogenism, such as acne, by Global Acne Grading System (GAGS) and Cardiff Acne Disability Index (CADI); body composition by dual-energy X-ray absorptiometry. All these parameters were collected at baseline and 60 days after supplementation with a new bioavailable and safe berberine formulation. Finally, adverse effects were assessed by liver and kidney functions. To evaluate statistically significant pre- post-supplementation changes, fitted a linear mixed model for each investigated endpoint was performed. #Intervention - DIETARY_SUPPLEMENT : Berberine - 2 daily oral doses (one before lunch and one dinner) of 550 mg of berberine tablets

#Eligibility Criteria: Inclusion Criteria: * normal and overweight women (Body Mass Index (BMI) 25 <= age <= 30 kg/m2) * newly detected Polycystic Ovary Syndrome Exclusion Criteria: * any concomitant medication * presence of liver, renal and thyroid disease * smoking * drinking more than two standard alcoholic beverages/day (20 g of alcohol/day) ##Sex : FEMALE ##Ages : - Minimum Age : 20 Years - Maximum Age : 35 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT ##Accepts Healthy Volunteers: Yes

{ "NCT_ID" : "NCT04316182", "Brief_Title" : "Cabozantinib in Patients With Hepatocellular Carcinoma (ACTION)", "Official_title" : "A Phase II triAl of Cabozantinib for hepaTocellular carcInoma Patients intOlerant to Sorafenib Treatment or First Line Treatment Different to sorafeNib. (ACTION Trial)", "Conditions" : ["Hepatocellular Carcinoma"], "Interventions" : ["Drug: Cabozantinib"], "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 Cabozantinib, a small molecule directed to vascular endothelial growth factor receptors, MET and AXL, has shown to significantly improve the overall survival (OS) over placebo in the randomized phase 3 CELESTIAL trial in patients who had up to two lines of prior systemic therapy (including sorafenib) with progression on at least one in comparison to patients who received best supportive care. Although cabozantinib shares similar targets with sorafenib/regorafenib, they present different toxicity profile. While the most common grade 3-4 Adverse Events reported for sorafenib were fatigue (4%), diarrhea (8%), hand-foot reaction (8%) and hypertension (2%); the most frequent grade 3-4 Adverse Events for cabozantinib were hand-foot reaction (3.6%), hypertension (3.4%) and elevation of AST (2.6%). In clinical practice, regorafenib, ramucirumab and cabozantinib are approved by European Medicines Agency (EMA) as second-line treatment approved by EMA until now. However, more than 40% of candidate patients to 2nd line do not meet the RESORCE criteria or REACH-2 trial and are only candidates to cabozantinib treatment. However, investigators do not have safety data about those patients who are treated with other treatments than sorafenib in first line neither data about the real impact of sorafenib-intolerant patients according to the RESORCE trial definition. For this reason, investigators propose to explore the role of cabozantinib in patients who were not considered in the CELESTIAL trial. #Intervention - DRUG : Cabozantinib - Cabozantinib 60 mg/day. Cabozantinib dose will be modified upon development of adverse events. - Other Names : - Cabometix

#Eligibility Criteria: Inclusion Criteria: * Hepatocellular Carcinoma (HCC) diagnosed according to criteria of American Association for the Study of Liver Diseases (AASLD) definition in 2010. * Intolerant to sorafenib according to RESORCE trial definition or patients who received treatment different to sorafenib as first-Line treatment. * The subject has disease that is not amenable to a curative treatment approach (eg, transplant, surgery, radiofrequency ablation) * Recovery to <= Grade 1 according to (CTCAE) v.5.0. from toxicities related to any prior treatments, unless the adverse events are clinically non-significant and/or stable on supportive therapy * Respect the 15 days of first-line treatment washout before starting cabozantinib * Age >= 18 years on the day of consent * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate hematologic function, based upon meeting the following laboratory criteria within 7 days before starting therapy: 1. absolute neutrophil count (ANC) >= 1200/mm3 (>= 1.2 x 10*9/L) 2. platelets >= 60,000/mm3 (>= 60 x 10*9/L) 3. hemoglobin >= 8 g/dL (>= 80 g/L) * Adequate renal function, based upon meeting the following laboratory criteria within 7 days before starting therapy: 1. Serum creatinine <= 1.5 × upper limit of normal or calculated creatinine clearance >= 40 mL/min (using the Cockcroft-Gault equation) AND 2. Urine protein/creatinine ratio (UPCR) <= 1 mg/mg (<= 113.1 mg/mmol) or 24-hour urine protein < 1 g * Child-Pugh Score of A * Total bilirubin <= 2 mg/dL (<= 34.2 μmol/L) within 7 days before starting therapy * Serum albumin >= 2.8 g/dL (>=28 g/L) within 7 days before starting therapy * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 5.0 upper limit of normal (ULN) within 7 days before starting therapy * Hemoglobin A1c (HbA1c) <= 8% within 28 days before starting therapy (if HbA1c results are unavailable [eg, hemoglobin variant], a fasting serum glucose <= 160 mg/dL) * Antiviral therapy per local standard of care if active hepatitis B (HBV) infection * Capable of understanding and complying with the protocol requirements and signed informed consent * Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception (eg, barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 4 months after the last dose of study treatment * Female subjects of childbearing potential must not be pregnant at screening. * Subjects must consent to perform a tumor liver biopsy within 4 weeks before starting cabozantinib, allowing the acquisition of a tumor sample for performance of correlative studies. Exclusion Criteria: * Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma * Radiation therapy (eg, I-131 or Y-90) within 4 weeks (2 weeks for radiation for bone metastases or radionuclide treatment within 6 weeks of starting therapy) (subject is excluded if there are any clinically relevant ongoing complications from prior radiation therapy) * Prior cabozantinib treatment * Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 3 months before starting therapy. Eligible subjects must be without corticosteroid treatment at the time of starting therapy. * Concomitant anticoagulation, at therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, low molecular weight heparin (LMWH), thrombin or coagulation factor X (FXa) inhibitors, or antiplatelet agents (eg, clopidogrel). Low dose aspirin for cardioprotection (per local applicable guidelines), low-dose warfarin (<= 1 mg/day), and low dose LMWH are permitted. * The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions a. Cardiovascular disorders including: i. Symptomatic congestive heart failure, unstable angina pectoris, or serious cardiac arrhythmias ii. Uncontrolled hypertension defined as sustained BP > 150 mm Hg systolic, or 100 mm Hg diastolic despite optimal antihypertensive treatment iii. Stroke (including TIA), myocardial infarction, or another ischemic event within 6 months before starting therapy iv. Thromboembolic event within 3 months before starting therapy. Subjects with thromboses of portal/hepatic vasculature attributed to underlying liver disease and/or liver tumor are eligible b. Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation: i. Tumors invading the GI tract, active peptic ulcer disease, inflammatory bowel disease (eg, Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis or acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction ii. Abdominal fistula, GI perforation, bowel obstruction, intra-abdominal abscess within 6 months before starting therapy iii. Note: Complete healing of an intra-abdominal abscess must be confirmed prior to starting therapy c. Major surgery within 2 months before starting therapy. Complete healing from major surgery must have occurred 1 month before starting therapy. Complete healing from minor surgery (eg, simple excision, tooth extraction) must have occurred at least 7 days before starting therapy. Subjects with clinically relevant complications from prior surgery are not eligible d. Cavitating pulmonary lesion(s) or endobronchial disease e. Lesion invading a major blood vessel including, but not limited to: pulmonary artery, or aorta. Subjects with lesions invading the portal vasculature are eligible. f. Clinically significant bleeding risk including the following within 3 months of starting therapy: hematuria, hematemesis, hemoptysis of >0.5 teaspoon (>2.5 mL) of red blood, or other signs indicative of pulmonary hemorrhage, or history of other significant bleeding if not due to reversible external factors g. Other clinically significant disorders such as: i. Active infection requiring systemic treatment, known infection with human immunodeficiency virus (HIV), or known acquired immunodeficiency syndrome (AIDS)-related illness. Subjects with active hepatitis virus infection controlled with antiviral therapy are eligible. ii. Serious non-healing wound/ulcer/bone fracture iii. Malabsorption syndrome iv. Uncompensated/symptomatic hypothyroidism v. Requirement for hemodialysis or peritoneal dialysis vi. History of solid organ transplantation * Subjects with untreated or incompletely treated varices with bleeding or high risk for bleeding. Subjects treated with adequate endoscopic therapy (according to institutional standards) without any episodes of recurrent GI bleeding requiring transfusion or hospitalization for at least 6 months prior to study entry are eligible. * Moderate or severe ascites. Note that controlled ascites with stable dose of diuretics in the last month is allowed. * Corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms within 7 days before starting therapy * Inability to swallow tablets * Previously identified allergy or hypersensitivity to components of the study treatment formulations * Pregnant or lactating females * Diagnosis of another malignancy within 2 years before starting therapy, except for superficial skin cancers, or localized, low-grade tumors deemed cured and not treated with systemic therapy * History of allergy to study drug components. * Prisoners or subjects who are involuntarily incarcerated * Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg. infectious disease) illness * Inability to comply with restrictions and prohibited activities/treatments. ##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

{ "NCT_ID" : "NCT00035607", "Brief_Title" : "Chemotherapy Related Anemia", "Official_title" : "A Randomized, Open-label, Multicenter Study of Subcutaneous and Intravenous Administration of Darbepoetin Alfa (Novel Erythropoiesis Stimulating Protein, NESP) for the Treatment of Anemia in Subjects With Non-myeloid Malignancies Receiving Multicycle Chemotherapy", "Conditions" : ["Anemia", "Non-Myeloid Malignancies"], "Interventions" : ["Drug: Darbepoetin alfa SC", "Drug: Darbepoetin alfa IV"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This study is investigating darbepoetin alfa for the treatment of anemia in patients with non-myeloid cancers who are receiving chemotherapy. Darbepoetin alfa is a recombinant protein that stimulates the production of red blood cells. In this study, darbepoetin alfa will be administered as either an injection under the skin (subcutaneously) or directly into a vein (intravenously). #Intervention - DRUG : Darbepoetin alfa SC - Subcutaneous (SC) injection of darbepoetin alfa at 4.5 mcg/kg weekly for weeks 1-6, then 4.5 mcg/kg Q3W - DRUG : Darbepoetin alfa IV - Intravenous administration of darbepoetin alfa at 4.5 mcg/kg weekly for weeks 1-6, then 4.5 mcg/kg Q3W

#Eligibility Criteria: Inclusion Criteria: * Diagnosed with a non-myeloid malignancy * Scheduled to receive a minimum of an additional 12 weeks of chemotherapy from the time of first dose of study drug * Screening hemoglobin concentration less than or equal to 11.0g/dL * ECOG performance status of 0 to 2 * Adequate renal and liver function Exclusion Criteria: * History of seizure disorder * Received recombinant human erythropoietin (rHuEPO) or darbepoetin alfa therapy within 4 weeks before study day 1 * More than 2 red blood cell transfusions within 4 weeks before study day 1, or any red blood cell transfusion within 14 days before study day 1 ##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

{ "NCT_ID" : "NCT00424099", "Brief_Title" : "Methylphenidate and a Nursing Telephone Intervention for Fatigue", "Official_title" : "A Randomized Controlled Trial of Methylphenidate and a Nursing Telephone Intervention (NTI) for Fatigue in Advanced Cancer Patients", "Conditions" : ["Advanced Cancer", "Fatigue"], "Interventions" : ["Behavioral: Nursing Telephone Intervention", "Drug: Placebo", "Drug: Methylphenidate", "Behavioral: Non NTI"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2", "PHASE3"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "TRIPLE" } }

#Study Description Brief Summary The goal of this clinical research study is to learn if methylphenidate (Ritalin) can help to control fatigue caused by cancer. Its effect on other symptoms such as drowsiness, depression, sleeplessness, physical activity, and anxiety will also be studied. Another goal of this study is to learn if receiving a phone call by a nurse improves fatigue in patients. Detailed Description Fatigue is one of the most common problems in patients with advanced cancer. Currently, there are no treatments for managing fatigue. Methylphenidate is a stimulant that increases ability to pay attention, increases mental alertness, and decreases feelings of fatigue. If you are found to be eligible to take part in this study, you will be randomly assigned (as in the roll of dice) to one of 4 groups. You will have an equal chance of being placed in any of the 4 groups. You, the medical staff, and researchers will not know to which group you have been assigned. Regardless of which group you are in, you will record your fatigue in a daily diary at breakfast, lunch, dinner, and before bedtime. Based on your level of fatigue, you will take the study drug as needed. You can take the study drug every 2 hours but you may not take more than 4 capsules a day. Participants in Group 1 will take a methylphenidate capsule by mouth as needed to relieve symptoms of fatigue for 14 days. A nurse will call you 4-6 times in the first two weeks to ask about side effects and other symptoms. The phone calls should take about 10-20 minutes. The study nurse will set up a convenient time for you to take the phone call. Participants in Group 2 will take a placebo capsule by mouth as needed for 14 days. A placebo is a capsule that does not contain any medication but looks just like the methylphenidate. A nurse will call you 4-6 times in the first two weeks to ask about side effects and other symptoms. The phone calls should take about 10-20 minutes. The study nurse will set up a convenient time for you to take the phone call. Participants in Group 3 will take a methylphenidate capsule by mouth as needed for 14 days. Participants in this group will not receive any calls from a study nurse. However, A research staff member will call you 4-6 times in the first two weeks to ask about side effects and other symptoms. The phone calls should take about 10-20 minutes. The research staff member will set up a convenient time for you to take the phone call. Participants in Group 4 will take a placebo capsule by mouth as needed for 14 days. Participants in this group will not receive any calls from a study nurse. However, A research staff member will call you 4-6 times in the first two weeks to ask about side effects and other symptoms. The phone calls should take about 10-20 minutes. The research staff member will set up a convenient time for you to take the phone call. You will be asked to wear a wrist actigraph monitor (a wristwatch that keeps track of your physical activity and your sleep cycles) for the first 14 days. You will keep a daily diary of your fatigue and other symptoms, the number and times pills are taken, and your fatigue rating before and 2 hours after taking methylphenidate. On about day 15 (or within 3 days) you will return to the palliative care clinic at M. D. Anderson for tests. You will be asked about your level of drowsiness, pain, constipation, and fatigue. You will be asked about any side effects you may have experienced and the effectiveness of the drug. You will repeat the 6 minute physical test, the cognitive status test, and you will return the actigraph monitor to the research nurse. You will also be given the option to receive up to 4 capsules of methylphenidate per day until Day 36. You will not be told whether you were taking placebo or methylphenidate during Days 1-14. If you cannot come to the clinic on Day 15, all tests except the walking test, may be performed over the telephone. You will be asked to mail the actigraph back. If you decide not to take methylphenidate on Days 15-36, you will be considered off-study and you will have end-of-study tests on Day 15. If you decide to take methylphenidate on Days 15-36, you will remain on study until Day 36. On Day 36, you will have end-of-study tests. For end-of-study tests, you will repeat the physical and cognitive tests. You will be asked about your symptoms and any side effects you may be experiencing. You will then return to your primary physician who will discuss with you whether or not to continue on the methylphenidate based on your response to the drug. Your participation in this study should end on either Day 15 or Day 36. However, if you develop intolerable side effects (including fatigue) while on this study, the medication will be stopped and you will be removed from the study. This is an investigational study. Methylphenidate has been approved by the FDA and is a commercially available drug. It is FDA approved at this dose level. Its use in this study, for this purpose, is investigational. About 212 patients will take part in this multicenter study. About 142 patients will be enrolled at The University of Texas (UT) MD Anderson. #Intervention - DRUG : Methylphenidate - 5 mg (one capsule) orally every two hours as needed up to a maximum of 20 mg per day for a period of 14 days. - Other Names : - Ritalin - BEHAVIORAL : Nursing Telephone Intervention - Call from study nurse 3 times weekly to ask about side effects and other symptoms. - Other Names : - NTI - DRUG : Placebo - One capsule, orally every two hours as needed up to a maximum of 4 capsules per day for a period of 14 days. - BEHAVIORAL : Non NTI - Non NTI are calls from research staff 3 times weekly. - Other Names : - Non Nursing Telephone Intervention

#Eligibility Criteria: Inclusion Criteria: * Patients will be eligible to participate in this study if they have advanced cancer. * Patients will be eligible to participate in this study if they rate fatigue on the Edmonton Symptom Assessment System (ESAS) during the last 24 hours as greater than or equal to 4 on a 0 <= age <= 10 scale, in which 0= no fatigue and 10=worst possible fatigue * Describe fatigue as being present every day for most of day for a minimum of 2 weeks * Lack clinical evidence of cognitive failure, with normal Mini Mental State Examination (MMSE). A score of 24 is considered normal * Are >= 18 years * Are willing to keep a daily diary, engage in telephone follow up with a nurse every other day, and return for follow-up visit after 14 days of treatment * Have telephone access to be contacted by the research nurse. If patient is relocating within 5 weeks, patient will be asked to provide a new telephone number * Hemoglobin of greater than or equal to 8 g/dl within 2 weeks of enrollment. If the patient has not had blood drawn for a hemoglobin level in the past 2 weeks, one will be done to determine the eligibility. Patients with a hemoglobin of less than 8 will be referred for treatment of their anemia * Able to understand the description of the study and give written informed consent. * Able to understand the description of assessments, and able to complete baseline assessment * Patients on no erythropoietin or stable dose. Exclusion Criteria: * Major contraindication to methylphenidate i.e. hypersensitivity, anxiety, tension, agitation, or motor tics, glaucoma, severe angina pectoris, or hypertension, etc. * Currently on methylphenidate or has been on methylphenidate within the last 10 days. * Inability to complete the baseline assessment forms or do understand the recommendations for participation in the study * Major depression according to the Structured Clinical Interview (SCID) Diagnostic and Statistical Manual of Mental Disorders (DSM) IV diagnostic criteria. These patients wil be referred immediately to psychiatry for assessment and management * Pregnant or lactating women * Requirement for Monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants or clonidine * Glaucoma, history of marked anxiety disorders * History of alcohol (CAGE questionnaire score for the last 2 years is 2 or above on a 0 to 4 scale) or substance abuse including illegal drugs and/or medications. * Tourette's syndrome * Symptomatic tachycardia and uncontrolled hypertension. * Currently receiving oral anticoagulants (Coumadin/warfarin), anticonvulsants (Phenobarbital, diphenylhydantoin, primidone), phenylbutazone, and tricyclic drugs (imipramine, clomipramine, desipramine). * Patients with pacemakers * Patients with symptomatic cardiac arrhythmias ##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

{ "NCT_ID" : "NCT04605276", "Brief_Title" : "Threedimensional Multiparametric Ultrasound for Prostate Cancer Detection", "Official_title" : "Improving the AI-based Image Analysis Algorithm for 3D Multiparametric Ultrasound for the Detection, Grading and Localization of Prostate Cancer", "Conditions" : ["Prostate Cancer"], "Interventions" : ["Other: No intervention"], "Location_Countries" : ["Netherlands"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary Rationale: Current imaging techniques for the detection and grading of prostate cancer are imperfect, leading to unnecessary biopsies, suboptimal treatment decisions and missed clinically significant cancers. The hypothesis of this study is that computer assisted analysis of 3D multiparametric ultrasound (mpUS) images can accurately detect, grade and localize prostate cancer. 3D mpUS may then become a more cost-effective and more streamlined imaging strategy than the current standard: mpMRI. Objective: The primary objective is to collect high-quality 3D mpUS and histology data, to train and improve the classifier algorithm with the goal of achieving an accurate ultrasound imaging tool for the detection of clinically significant prostate cancer. Secondary objectives are related to the preliminary assessment of the performance of 3D mpUS with computer assisted analysis. Study design: This is a prospective, multi-center study in men with a suspicion of prostate cancer who are scheduled for prostate biopsies, and men with confirmed prostate cancer who are scheduled to undergo a radical prostatectomy. Prior to prostate biopsies or the radical prostatectomy, 3D mpUS imaging will be performed. The ultrasound images will be analyzed and used for algorithm training using the biopsies and/or prostatecomy specimens as gold standard. Additional research coupes of pathology material (both biopsies and radical prostatectomy specimens) from study subjects will be anonymized and separately analyzed and stored in a central, independent institution. The outcome of the 3D mpUS analysis and the additional pathology evaluation are for research purposes only and will not interfere with standard patient care. Study population: 1) Male patients of age ≥18 suspected for prostate cancer who are scheduled for systematic and/or targeted biopsy after mpMRI examination. 2) patients of age ≥18 with confirmed prostate cancer who are scheduled for radical prostatectomy. Main study parameters/endpoints: * Gleason/Grade group scoring based on histology. Using histology as the reference standard the accuracy of the algorithm will be optimized to be differentiating between benign tissue and various grades of malignancy. * Localization and size of lesions at full-gland histology in the subset of patients undergoing radical prostatectomy. Correlation in tumour size and location will be optimized between 3D mpUS findings and histology of the full gland. For the secondary objective, preliminary assessment of the performance of 3D mpUS, the following endpoints are evaluated * Among all clinically significant detected cancers confirmed by histology, the proportion of these cancers that would have been detected by 3D mpUS will be calculated. The number of false positive findings by 3D mpUS both as an absolute count and expressed as a mean rate per patient. * The concordance in the detection and grading of abnormalities between mpMRI and 3D mpUS by examining the frequency and type of disagreements and calculating the kappa statistic. #Intervention - OTHER : No intervention - No intervention

#Eligibility Criteria: Inclusion criteria In order to be eligible to participate in this study, a subject must meet all of the following criteria: * Men >=18 years with a clinical suspicion of prostate cancer or confirmed prostate cancer. * Scheduled for either systematic and/or targeted biopsy after mpMRI examination or radical prostatectomy * Signed informed consent Exclusion criteria A potential subject who meets any of the following criteria will be excluded from participation in this study: * No mpMRI performed prior to prostate biopsy or radical prostatectomy * A history of chemotherapy for PCa or currently being treated with chemotherapy for PCa. * A patient history that includes any of the following prostate related interventions: * Brachytherapy or external radiotherapy for PCa; * Focal therapy for prostate cancer; * Prostate biopsy within the last 30 days. * Hormonal therapy for prostate cancer within the last six months * A patient history with a cardiac right to left shunt. * Current treatment with dobutamine * Known severe pulmonary hypertension (pulmonary artery pressure >90 mmHg), uncontrolled systemic hypertension or respiratory distress syndrome * Incapable of understanding the language in which the patient information is given. ##Sex : MALE ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00400569", "Brief_Title" : "Phase II Study of Sunitinib Malate for Metastatic and/or Surgically Unresectable Soft Tissue Sarcoma", "Official_title" : "Phase II Open-Label Study of Sunitinib Malate (SU011248) in Adult Patients With Metastatic and/or Surgically Unresectable Soft Tissue Sarcoma", "Conditions" : ["Liposarcoma", "Leiomyosarcoma", "Fibrosarcoma", "Malignant Fibrous Histiocytoma"], "Interventions" : ["Drug: Sunitinib Malate (SU011248)"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is an open label single site Phase II clinical trial to identify a potentially promising therapy dose for Sunitinib malate. The study drug will be taken orally once daily on days 1 through 28 of each 42 day cycle. Treatment will be continued until there is either disease progression or cumulative/acute toxicity. All patients with unresectable or metastatic soft tissue sarcoma (STS): leiomyosarcoma, liposarcoma, fibrosarcoma, and malignant fibrous histiocytoma (MFH) seen at the Moffitt Cancer Center will be screened for eligibility to be enrolled in the study. Detailed Description This is an open label single site Phase II clinical trial to identify a potentially promising therapy dose for Sunitinib malate, an oral multi-kinase inhibitor. The study drug will be taken orally once daily on days 1 through 28 of each 42 day cycle. Treatment will be continued until there is either disease progression or cumulative/acute toxicity which in the opinion of the treating physician or the trial Principal Investigator (PI) compromises the ability of the patient to receive treatment or the patient desires to stop treatment. All patients with unresectable or metastatic STS: leiomyosarcoma, liposarcoma, fibrosarcoma, and MFH seen at the Moffitt Cancer Center will be screened for eligibility to be enrolled in the study. An office visit will be required before the beginning of every cycle every 6 weeks to assess toxicity and for physical examination. Complete blood count (CBC) and differential, comprehensive metabolic panel, and electrocardiogram (ECG) will be obtained at every scheduled visit. #Intervention - DRUG : Sunitinib Malate (SU011248) - For each 6 week cycle, patients will take SU011248 every day in the morning for 4 weeks followed by a 2 week rest period. - Other Names : - Sutent, SU011248

#Eligibility Criteria: Inclusion Criteria: * Resolution of all acute toxic effects of prior chemotherapy or radiotherapy or surgical procedures to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 grade less than or equal to 1. * Adequate organ function as defined by the following criteria: * Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) less than or equal to 2.5 x local laboratory upper limit of normal (ULN), or AST and ALT less than or equal to 5 x ULN if liver function abnormalities are due to underlying malignancy * Total serum bilirubin less than or equal to 1.5 x ULN * Absolute neutrophil count (ANC) greater than or equal to1500/microL * Platelets greater than or equal to 100,000/microL * Hemoglobin greater than or equal to 9.0 g/dL * Serum calcium less than or equal to 12.0 mg/dL * Serum creatinine less than or equal to 1.5 x ULN * Histologically-proven liposarcoma, leiomyosarcoma, fibrosarcoma, or MFH * Measurable disease radiographically * Disease that is deemed surgically unresectable and/or metastatic * Age greater than or equal to 18 years * Life expectancy greater than 16 weeks * Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 * Patients may have had up to 3 prior chemotherapies within 4 weeks of starting the study treatment. Exclusion Criteria: * Major surgery or radiation therapy or chemotherapy within 4 weeks of starting the study treatment. * NCI CTCAE version 3 grade 3 hemorrhage within 4 weeks of starting the study treatment. * History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease. * Any of the following within the 6 months prior to study drug administration: * myocardial infarction, * severe/unstable angina, * coronary/peripheral artery bypass graft, * symptomatic congestive heart failure, * cerebrovascular accident or transient ischemic attack, or pulmonary embolism * Ongoing cardiac dysrhythmias of NCI CTCAE greater than or equal to grade 2 * Prolonged QTc interval on baseline electrocardiogram (ECG) > 500 msec. * Hypertension that cannot be controlled by medications (>150/100 mm Hg despite optimal medical therapy) * Prior tyrosine kinase inhibitor therapy * Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication * Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness or other active infection * Concurrent treatment on another clinical trial, except supportive care or non-treatment trials * Concomitant use of agents known to induce or inhibit CYP3A4 * Concomitant use of agents metabolized by the cytochrome P450 system * Ongoing treatment with therapeutic doses of Coumadin (low dose Coumadin up to 2 mg by mouth [PO] daily for thrombo-prophylaxis is allowed) * Pregnancy or breastfeeding patients * Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study. ##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

{ "NCT_ID" : "NCT03778450", "Brief_Title" : "Long-term Opioid Therapy, Misuse and Mortality in Patients With Chronic Non-cancer Pain in Germany", "Official_title" : "Long-term Opioid Therapy, Misuse and Mortality in Patients With Chronic Non-cancer Pain in Germany", "Conditions" : ["Pain"], "Interventions" : ["Drug: Non-Opioid Analgesic", "Drug: Analgesics, Opioid"], "Location_Countries" : ["Germany"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary Among patients receiving opioids for noncancer pain, recent research in North America showed a strong association between doses and opioid-related mortality, especially at dosages exceeding thresholds recommended in recent guidelines. However, the focus on over-dosage may underestimate overall opioid-related mortality and data on death associated with opioid use in a population-based cohort of chronic noncancer pain patients in Europe is scarce. Especially comparative studies studying the safety of long-term opioid therapy in a real-world setting relative to non-opioid medication for chronic noncancer pain are needed in a European context. Detailed Description This is a cross-sectional observational cohort study between 2012 and 2017 of patients with chronic noncancer pain. The primary objective is to investigate the association between mortality among patients with chronic noncancer pain with long-term opioid-therapy compared to non-opioid pain medication. The data will be retrieved from an anonymized German health claims database including 4,00,000 persons insured by 69 German statutory health insurances. The data set includes 5.0% of the population covered by statutory health insurances from January 1, 2012, to December 31, 2017. Only anonymized and aggregated data (no directly or indirectly identifying data) will be extracted. Patients with headache, diseases of the musculoskeletal system and connective tissue, migraine, trigeminal neuralgia, atypical facial pain, persistent somatoform pain disorder, polyneuropathies, or diabetes mellitus with neurological complications in at least 3 quarters between 01.01.2012 and their first pain medication claim are analyzed. Patients will be stratified in an opioid and a non-opioid group and will be compared with a propensity score matching approach. Patients' follow-up period include 5 years after start treatment and chronic pain diagnosis between 01.01.2013 and 31.12.2017. Each patient will be censored at death (death date), switching of study group, 12 months without treatment or followed-up 5 years until last known record for the, whichever happens first. The main analyses will be analyzed with a multivariate Cox proportional hazards regression. #Intervention - DRUG : Analgesics, Opioid - Patients are included in the long-term opioid group if they started an opioid-therapy between 2013 and 2017 and received consecutive prescriptions for opioid medications over a minimum of 3 quarters, over a 60-month period between January 1, 2013, and December 31, 2017. The treatment will be assessed using the ATC codes of opioid treatment N02AA01, N02AA05, N02AB03, N02AE01, N02AX02, N02AX01, N02AX06) reported in reimbursed medicines to patients. - Other Names : - Opioid Group - DRUG : Non-Opioid Analgesic - Patients with non-opioid pain medication are included, if they received a medication therapy with anticonvulsants (gabapentin, pregabalin, carbamazepine), antidepressants or non-opioid analgesics (NSAIDs, Metamizole) over a minimum of 3 quarters, over a 60-month period between January 1, 2013, and December 31, 2017. The non-opioid treatment will be assessed using the ATC codes (N03AX12, N03AX16, N03AF01) of treatment reported in reimbursed medicines to patients. - Other Names : - Non-Opioid Group

#Eligibility Criteria: Inclusion Criteria: * Patients are only included if they have been diagnosed in at least three quarters in the study period with one of the following diagnoses: R51, R52*, M00*-M99*, G43*-G44*, G50.0 or G50.1, F45.4*, G62*, or E10.4*-E14.4 plus G63.3. At least one diagnoses must be between 1 January 2012 and index treatment and main and secondary hospital diagnoses (i.e. Haupt- und Nebendiagnosen) will be used to include the patients. Exclusion Criteria: * Patients with present opioid and non-opioid pain medication prescriptions in 2012 are excluded from analysis (therapy-naïve patients only). * Cancer patients will be excluded if the cancer diagnosis is accompanied by at least one of the following treatments in the same quarter: radiation therapy or chemotherapy all defined by the OPS codes in. Diagnoses will be assessed via ICD-10 diagnoses during the inclusion period from 1 January 2012 until index treatment and main and secondary hospital diagnoses (i.e. Haupt- und Nebendiagnosen) will be taken into account. * Palliative care, coded by ICD-10 code Z51.5 or OPS code 8 <= age <= 982*, 8 <= age <= 98e*, 8 <= age <= 98h* before index date is excluded * Opioid substitution treatment with ICD-10 code Z51.83 in the study period is excluded. ##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

{ "NCT_ID" : "NCT03639194", "Brief_Title" : "A Study of ABBV-011 Alone and in Combination With Budigalimab (ABBV-181) in Participants With Relapsed or Refractory Small Cell Lung Cancer", "Official_title" : "A Phase I Study of ABBV-011 as a Single-Agent and in Combination With Budigalimab (ABBV-181) in Subjects With Relapsed or Refractory Small Cell Lung Cancer", "Conditions" : ["Small Cell Lung Cancer"], "Interventions" : ["Drug: ABBV-011", "Drug: Budigalimab"], "Location_Countries" : ["United States", "Japan", "Korea, Republic of", "Taiwan"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SEQUENTIAL", "Masking" : "NONE" } }

#Study Description Brief Summary This is a multicenter, open-label, Phase 1 study of ABBV-011 given as a single agent and in combination with budigalimab (ABBV-181) in participants with relapsed or refractory small cell lung cancer (SCLC). The study consists of 4 parts: Part A is a single-agent ABBV-011 dose regimen finding cohort; followed by Part B, a single-agent ABBV-011 dose expansion cohort; and then Part C, an ABBV-011 and budigalimab (ABBV-181) combination escalation and expansion cohort; Part D, single-agent ABBV-011 dose-evaluating cohort for Japan. #Intervention - DRUG : ABBV-011 - Intravenous - Other Names : - SC-011 - DRUG : Budigalimab - Intravenous - Other Names : - ABBV-181

#Eligibility Criteria: Inclusion Criteria: * Histologically or cytologically confirmed small cell lung cancer (SCLC) that is relapsed or refractory following at least 1 prior platinum-containing chemotherapy, but no more than 3 total prior lines of therapy, and with no curative therapy available. * Measurable disease, defined as at least 1 tumor lesion greater than or equal to 10 mm in the longest diameter or a lymph node greater than or equal to 15 mm in short axis measurement assessed by computed tomography (CT) scan, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Minimum life expectancy of at least 12 weeks. * Recovery to at least Grade 1 of any clinically significant toxicity (excluding alopecia) prior to initiation of study drug administration. * Adequate hematologic, hepatic, neurologic, and renal function. * All participants in Part B and Part C will be required to have tumor tissue that tests positive for target expression. * Sponsor may elect for confirmed SCLC tumor tissue to test positive for target expression for Parts A and D participants as well. * Last dose of any prior anticancer therapy >= 4 weeks before the first dose of study drug. Additional Inclusion Criteria for Study Part B and Part C: * SCLC tumor tissue that tests positive for seizure-related homolog 6 (SEZ6) by immunohistochemistry (IHC). Exclusion Criteria: * History of confirmed or suspected liver cirrhosis, hepatic veno-occlusive disease (VOD), sinusoidal obstruction syndrome (SOS), alcohol dependence, or ongoing excessive alcohol use. * Prior history of allogeneic or autologous stem cell transplantation. * Documented history of stroke or clinically significant cardiac disease as described in the protocol within 6 months prior to the first dose of study drug. * History of cardiac conduction abnormalities as described in the protocol. * Recent or ongoing serious infection, as described in the protocol. * Active SARS-CoV-2 infection. * Prior or concomitant malignancies with some exceptions, as described in the protocol. * Any significant medical or psychiatric condition, including any suggested by Screening laboratory findings, that in the opinion of the Investigator or Sponsor may place the participant at undue risk from the study treatment, interfere with interpretation of study results, or compromise ability to comply with protocol requirements. * Participants with a history of hypersensitivity to the active ingredients or any excipients of study drugs (ABBV-011 or budigalimab [ABBV-181]) will be excluded. Additional Exclusion Criteria for Part C: * History of inflammatory bowel disease. * Peripheral neuropathy Grade 2 with pain, or Grade 3 or higher. * Body weight less than 35 kilograms. * Active pneumonitis or interstitial lung disease (ILD) or a history of pneumonitis/ILD requiring treatment with steroids. * Participants previously treated with an anti PD-1/PD-L1 targeting agent must meet additional criteria described in the protocol. * Participant is judged by the Investigator to have evidence of ongoing hemolysis. * Immunosuppressive use with exceptions as per protocol. * Participants who have received a live vaccine within 30 days of start of study treatment. * Active autoimmune disease with exceptions as indicated in the protocol. * History of primary immunodeficiency, solid organ transplantation, or previous clinical diagnosis of tuberculosis. * Participants with a history of Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or drug reaction with eosinophilia and systemic symptoms (DRESS). Additional exclusion criteria for Japanese and Korean participants: * Participants with a history of interstitial lung disease (pneumonitis) or current interstitial lung disease (pneumonitis). ##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

{ "NCT_ID" : "NCT01746979", "Brief_Title" : "Clinical Trial Testing TH-302 in Combination With Gemcitabine in Previously Untreated Subjects With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma", "Official_title" : "A Randomized, Double-Blind, Phase III Study of the Efficacy and Safety of Gemcitabine in Combination With TH-302 Compared With Gemcitabine in Combination With Placebo in Previously Untreated Subjects With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma", "Conditions" : ["Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma"], "Interventions" : ["Drug: Placebo (5 percent dextrose - D5W)", "Drug: Gemcitabine", "Drug: TH-302"], "Location_Countries" : ["United States", "Germany"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "DOUBLE" } }

#Study Description Brief Summary This Phase 3 trial is a randomized, double-blind, placebo-controlled trial of gemcitabine in combination with TH-302 compared to gemcitabine in combination with placebo in subjects with locally advanced unresectable or metastatic pancreatic adenocarcinoma. Randomized subjects will receive TH-302 plus gemcitabine or gemcitabine plus placebo in 4-week cycles until there is evidence of progressive disease, intolerable toxicity, or the subject discontinues from the trial for other reasons (for example, withdrawal of consent). The primary efficacy endpoint is overall survival (OS) time. The data cut-off for statistical analyses of the primary and secondary endpoints will be reached when 508 events (deaths) will be reported. No planned interim analyses will be conducted. An Independent Safety Monitoring Board (ISMB) will provide periodic evaluations of the unblinded safety data to ensure subject safety and the validity and scientific merit of the study. A total of 660 subjects will be enrolled. #Intervention - DRUG : TH-302 - TH-302 will be administered at a dose of 340 milligrams per square meter (mg/m\^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal. - DRUG : Gemcitabine - Gemcitabine will be administered at a dose of 1000 (mg/m\^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal. - DRUG : Placebo (5 percent dextrose - D5W) - TH-302 placebo (5 percent dextrose - D5W) will be administered as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.

#Eligibility Criteria: Inclusion Criteria: * At least 18 years * Locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma proven by histology or cytology and previously untreated with chemotherapy or systemic therapy other than: * Radiosensitizing doses of 5-fluorouracil; * Radiosensitizing doses of gemcitabine if relapse occurred at least 6 months after completion of gemcitabine; * Neoadjuvant chemotherapy if relapse occurred at least 6 months after surgical resection; * Adjuvant chemotherapy if relapse occurred at least 6 months after completion of adjuvant chemotherapy * Measurable disease (at least one target lesion outside of previous radiation fields) or non-measurable disease by RECIST v.1.1 criteria * Documentation of disease progression since any prior therapy * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Life expectancy of at least 3 month * Acceptable liver, renal function and acceptable hematological status * Other protocol defined inclusion criteria may apply Exclusion Criteria: * New York Heart Association (NYHA) Class III or IV congestive heart failure, myocardial infarction within 6 months prior to the date of randomization, unstable arrhythmia or symptomatic peripheral arterial vascular disease * Symptomatic ischemic heart disease * Known brain, leptomeningeal or epidural metastases (unless treated and well controlled for at least 3 months) * Previous malignancy other than pancreatic cancer in the last 5 years, except for adequately treated non-melanoma skin cancer or pre-invasive cancer of the cervix * Severe chronic obstructive or other pulmonary disease with hypoxemia * Major surgery, other than diagnostic surgery, less than or equal to 28 days prior to the date of randomization. Subject must have completely recovered from surgery * Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy * Treatment of pancreatic cancer with radiation therapy or surgery less than or equal to 28 days prior to the date of randomization * Prior therapy with a hypoxic cytotoxin * Subjects who participated in an investigational drug or device trial less than or equal to 28 days prior to Day 1 of the first cycle * Known infection with Human Immunodeficiency Virus (HIV), or an active infection with Hepatitis B or Hepatitis C * Subjects who have exhibited allergic reactions to a structural compound similar to TH-302 or the drug product excipients or to gemcitabine or its excipients * Other protocol defined exclusion criteria may apply ##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

{ "NCT_ID" : "NCT01326325", "Brief_Title" : "Efficacy of Low Analgesic Doses of Ketamine Associated With Opioids in Refractory Cancer Pain Treatment", "Official_title" : "Study of the Efficiency of the Ketamine With Low Analgesic Doses, in Association With High Opioids, in the Treatment of the Rebels Pains, in Palliative Phase of the Cancerous Disease", "Conditions" : ["Pain"], "Interventions" : ["Drug: Ketamine", "Drug: NaCl"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "QUADRUPLE" } }

#Study Description Brief Summary Long-term opioid therapy is commonly administered for the management of severe cancer pain. Increasing doses of opioids are titrated against effects until analgesia is achieved or intolerable adverse effects occur. Ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, has been reported to improve analgesia in patients with uncontrolled pain receiving high doses of opioids. This study aims at determining the effectiveness of ketamine as an adjuvant to opioids in relieving cancer pain. Detailed Description Main objective: To show that low analgesic doses of ketamine in intravenous infusion during 4 days associated with opioids better relieve refractory cancer pain than opioids without ketamine. This study is a prospective study, multicenter (11 centres), consisting of 3 phases: * a randomized controlled double blind phase of 5 days with 2 parallel groups of 38 patients each : ketamine (in association with high opioids), in intravenous injection during 4 days, versus placebo (in association with high opioids), in intravenous injection during 4 days ; * an open-label phase of maximum 4 days, during which the ketamine Panpharma® is administered in intravenous infusion to the hospitalized patients who are still having uncontrolled pain persisting or recurrent ; * an observational phase : starting at the discharge of the patient, of a maximal period of 6 months.The inclusion period is during 18 months, the total duration of the study is 2 years. 76 patients are expected: 38 will be treated with opioids and ketamine; 38 will be treated with opioids and a placebo. Success is defined by a decrease of the daily pain score of 50 % after 4 days. The expected rate of success in the placebo group is 10 % whereas the expected rate of success in the ketamine group is 30 %. Primary outcome (pain score on a 11-point numerical scale) will be evaluated everyday as well as secondary outcomes (patient and clinician global impression of change, opioid consumption, adverse reactions, patient satisfaction on pain relief, sleep interference score). Vital parameters (cardiac frequency, respiratory frequency and arterial blood pressure) will be checked everyday, many times a day : every hour for the four hours after the beginning of the treatment and then, every four hours ; every hour for the two hours following a dose shift). #Intervention - DRUG : Ketamine - Drip continues of ketamine in intravenous injection included posology enters 0,5mg/kg /day and 2mg/kg/day during 4 days - DRUG : NaCl - Drip continues of NaCl 0,9% in intravenous injection during 4 days

#Eligibility Criteria: Inclusion Criteria: * Hospitalized cancer patients (informed and conscious of the cancer diagnostic) * Undergoing opioid treatment for 15 days at least * Refractory pain (score higher than 5 on an 10-point numerical pain rating scale) * Ability to score pain on a numerical pain rating scale * Patient written agreement Exclusion Criteria: * Ketamine contraindications * Methadone or other NMDA-antagonist treatment * Karnofsky index under 10 * Pregnancy ##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

{ "NCT_ID" : "NCT02625935", "Brief_Title" : "Prospective Observational Study Evaluating Treatment Decision Impact of Prosigna® in Early Stage Breast Cancer Patients", "Official_title" : "A Prospective Observational Study Evaluating Treatment Decision Impact of Prosigna® in Early Stage Breast Cancer Patients Who Are Candidates for Genomic Testing", "Conditions" : ["Breast Cancer"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary This multicenter, prospectively designed study examines whether the Prosigna score influences physician and patient adjuvant treatment selection over and above currently used prognostic factors. This study also examines the impact of the test results on patients' reported outcomes, including their decisional conflict status and anxiety levels. Detailed Description The primary objective of this study is to assess the extent to which the Prosigna test results affect the medical oncologist's treatment recommendations regarding adjuvant chemotherapy and actual treatments received for patients with early stage breast cancer conventionally considered candidates for genomic testing based on current treatment guidelines. The oncologist's initial recommendations will be based on the utilization of tools or algorithms based on clinical and pathologic factors. No genomic tools will be used in the initial assessment. Changes in recommendation after availability of Prosigna test results will include (1) hormonal therapy alone or (2) hormonal therapy plus chemotherapy, and (3) changes in types of chemotherapy if chemotherapy was recommended before and after the test.

#Eligibility Criteria: Inclusion Criteria: * Surgically resected node-negative, estrogen receptor-positive, HER2-negative early-stage invasive breast cancer (T1-T2, N0, pN0 (i+), pN0 (mol+), M0) 1. Estrogen receptor status will be evaluated by Immunohistochemistry (IHC) and more than 1% of stained tumor cells will be considered positive. 2. HER2 status will be evaluated by IHC and/or by in-situ fluorescence hybridization (0 or 1+, or 2+ will be considered negative in the absence of in-situ fluorescence hybridization). * Postmenopausal females, which is defined as: 1. Natural Amenorrhea > 12 months, regardless of age 2. Bilateral oophorectomy, regardless of age (the oophorectomy must have been carried out at least 4 weeks before entering the study) 3. Radiological castration with amenorrhea > 3 months, regardless of age 4. Hysterectomy and postmenopausal blood levels of FSH/LH * Able to give informed consent * Eligible for treatment of breast cancer with adjuvant chemotherapy, as determined by the treating physician * ECOG performance status of 0 or 1 Exclusion Criteria: * Tumor specimen from core needle biopsy (CNB) * Tumor stage T3-T4 * Non-invasive breast cancer (e.g., Paget's disease, DCIS) * Tumors with nodes that are not N0, pN0 (i+), or pN0 (mol+) * Tumors that are estrogen receptor (ER) negative or HER2-positive * Have metastatic disease * Have received another genomic test for prognosis of early breast cancer (i.e., Oncotype Dx, Mammaprint, or BCI) * Unable to give informed consent * Unable to complete patient reported outcome surveys * Have contraindications for adjuvant chemotherapy, as determined by the treating physician o Age, performance status, significant comorbidities, etc. * ECOG performance status > 1 ##Sex : FEMALE ##Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01799031", "Brief_Title" : "Educational Intervention for Reducing Work Disability in Breast Cancer Survivors", "Official_title" : "Reducing Work Disability in Breast Cancer Survivors", "Conditions" : ["Breast Cancer", "Cancer Survivor"], "Interventions" : ["Procedure: quality-of-life assessment", "Other: educational intervention", "Procedure: management of therapy complications", "Other: internet-based intervention", "Other: questionnaire administration"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This randomized clinical trial studies an educational intervention for reducing work disability in breast cancer survivors. Web sites providing symptom management education may be an effective method to help breast cancer survivors reduce work disability after treatment Detailed Description PRIMARY OBJECTIVES: I. Determine the feasibility and usability of the Work Ability Improvement Through Symptom Management and Ergonomic Strategies (WISE) and empirically evaluate its effect on short-term work ability among breast cancer survivors (BCS). SECONDARY OBJECTIVES: I. Explore individual and workplace factors associated with work ability in BCS. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive access to the WISE web-based educational intervention to help BCS manage their symptoms, identify ergonomic workplace problems and risks, and implement ergonomic modifications. Patients also receive standard of care comprising symptom management therapies and a pamphlet on employment rights. ARM II: Patients receive standard of care comprising symptom management therapies and a pamphlet on employment rights. After completion of study treatment, patients are followed up at 3 and 6 months. #Intervention - OTHER : internet-based intervention - Receive access to the WISE web-based educational intervention - PROCEDURE : management of therapy complications - Receive standard of care - Other Names : - complications of therapy, management of - OTHER : educational intervention - Receive access to the WISE web-based educational intervention - Other Names : - intervention, educational - OTHER : questionnaire administration - Ancillary studies - PROCEDURE : quality-of-life assessment - Ancillary studies - Other Names : - quality of life assessment

#Eligibility Criteria: Inclusion Criteria: * Diagnosed with breast cancer * Employed at time of cancer diagnosis (defined as paid employment > 20 hours/week) * Within six months of completion of active treatment * Working during treatment or intending to return to work following active treatment * Computer and internet access Exclusion Criteria: * Patients who do not intend to continue/resume working following treatment * Develop distant metastases or progressive disease * Prior diagnosis of malignancy at any other site except for in situ carcinomas of the cervix or non-melanomatous skin cancers ##Sex : FEMALE ##Ages : - Minimum Age : 25 Years - Maximum Age : 64 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT04393753", "Brief_Title" : "Domatinostat in Combination With Avelumab in Patients With Advanced Merkel Cell Carcinoma Progressing on Anti-PD-(L)1", "Official_title" : "A Phase II, Open Label Study to Investigate the Efficacy and Safety of Domatinostat in Combination With Avelumab in Patients With Advanced Unresectable/Metastatic Merkel Cell Carcinoma Progressing on Anti-PD-(L)1 Antibody Therapy", "Conditions" : ["Merkel Cell Carcinoma"], "Interventions" : ["Drug: domatinostat in combination with avelumab"], "Location_Countries" : ["Italy", "Spain", "France", "Germany", "Belgium", "Netherlands"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This phase II trial studies how well domatinostat (4SC-202) works in combination with avelumab in adult patients with advanced unresectable and/or metastatic Merkel Cell Carcinoma that have progressed on a previous therapy with an anti-PD-(L)1 antibody #Intervention - DRUG : domatinostat in combination with avelumab - domatinostat tablets and avelumab infusion

#Eligibility Criteria: Inclusion Criteria: * Histologically confirmed Merkel Cell Carcinoma (MCC) * ECOG performance status <= 1 * MCC in an advanced, unresectable stage III or metastatic stage IV (includes patients who refused surgical resection or are not eligible for such surgical resection) * Progressing on previous anti-PD-(L)1 antibody monotherapy within the last 12 weeks before planned first administration of study medication Exclusion Criteria: * History of serious anti-PD-(L)1 therapy-related adverse reactions prohibiting further avelumab treatment * More than one line of previous systemic anti-neoplastic therapy other than anti-PD-(L)1 antibody monotherapy * Palliative radiation therapy of single lesions within 2 weeks before planned administration of study medication * Presence of significant active or chronic disease (infections, immunodeficiencies, cardiovascular, psychiatric disorders) ##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

{ "NCT_ID" : "NCT00697814", "Brief_Title" : "Clomiphene in Males With Prolactinomas and Persistent Hypogonadism", "Official_title" : "Recovery of Gonadal Function by Clomiphene in Males With Prolactinomas and Persistent Hypogonadism", "Conditions" : ["Hypogonadotropic Hypogonadism", "Prolactinoma"], "Interventions" : ["Drug: Clomiphene citrate"], "Location_Countries" : ["Brazil"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", } }

#Study Description Brief Summary Prolactinomas are usually associated with hypogonadotropic hypogonadism in both sexes. Clomiphene citrate is a well known selective estrogen receptor modulator that increases gonadotropin secretion via hypothalamic-pituitary action. We conducted a prospective, open label clinical trial of CC to evaluate its effects in reverting persistent HH in male patients with prolactinomas under dopaminergic agonist treatment. #Intervention - DRUG : Clomiphene citrate - Clomiphene 50 mg/day for 12 weeks

#Eligibility Criteria: Inclusion Criteria: * a minimum follow-up of 6 months under DA therapy with normal serum prolactin or with maximum DA dose (3.5 mg/week of cabergoline or 10 mg/day of bromocriptine for at least 2 months) * serum total testosterone less than 300ng/dl with normal or low LH and FSH levels after discontinuing testosterone replacement for at least 2 months. Exclusion Criteria: * impossibility to attend scheduled visits and irregular compliance to DA treatment. ##Sex : MALE ##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

{ "NCT_ID" : "NCT00642031", "Brief_Title" : "Triciribine Phosphate Monohydrate (TCN-PM, VD-0002) in Adult Patients With Advanced Hematologic Malignancies", "Official_title" : "A Phase I Study of Triciribine Phosphate Monohydrate (TCN-PM, VD-0002) in Adult Patients With Advanced Hematologic Malignancies", "Conditions" : ["Hematologic Malignancies", "Leukemia"], "Interventions" : ["Drug: Triciribine"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Primary objective: To determine the dose limiting toxicity (DLT) and maximum tolerated dose (MTD) of TCN-PM (Triciribine) when administered as an approximately one-hour intravenous infusion on a weekly schedule on days 1, 8 and 15 in a 28 day cycle in patients with advanced hematologic malignancies; To determine the pharmacokinetics (PK) of Triciribine following study drug administration. Secondary objective: To observe the anti-tumor effects of Triciribine, if any occur Detailed Description Triciribine is designed to prevent development of certain proteins which participate in the abnormal growth of cancer cells. Before you can start treatment on this study, you will have 'baseline tests.' These tests will help the doctor decide if you are eligible to take part in the study. You will have a physical exam, including measurement of vital signs (blood pressure, heart rate, temperature, and breathing rate). Your complete medical history will be recorded. You will be asked about your ability to perform everyday activities. You will have blood (about 4 teaspoons) and urine collected for routine tests. You will have an electrocardiogram (ECG - a test to measure the electrical activity of the heart). Women who are able to have children must have a negative blood (about 1 teaspoon) or urine pregnancy test. You will also have a bone marrow aspiration and/or biopsy performed during the baseline testing. To collect a bone marrow aspirate and biopsy, an area of the hip or chest bone is numbed with anesthetic and a small amount of bone marrow and bone is withdrawn through a large needle. Certain patients who are at risk for involvement of disease in their central nervous system may be required to have a lumbar puncture (spinal tap) done. A lumbar puncture involves inserting a needle between the vertebrae of the back and then removing a small amount of spinal fluid. The fluid will be checked for diseased cells, used to measure the level of study drug in the fluid, and used to measure the level of a substance that shows how the study drug is being handled by your body. If you are found to be eligible for this study, you will start receiving Triciribine through a needle in a vein, over about 1 hour, on Days 1, 8, and 15 of each 28-day study 'cycle.' On each day you receive Triciribine, your vital signs will be measured before the start of the infusion, at 30 minutes (half-way through the infusion), at the end of the infusion, and at 1 hour after completing the infusion. An ECG will be done at the end of the infusion on Day 1 of the first cycle only. The amount of Triciribine you receive in each infusion will depend on when you enter the study. At least 3 participants will be enrolled at each dose level. Each new group of participants will receive a higher dose level than the group before, unless a level is reached where the side effects are considered intolerable. This will help researchers to find out the highest tolerable dose of Triciribine. During the study, researchers will be checking the status of the cancer to see how it is responding to the study drug. You will be checked once a week, or more often, depending on how you are doing and according to your blood cell counts. Each check-up includes measurement of your vital signs and blood (about 4 teaspoons) drawn for routine tests. You will be asked about any side effects you may have experienced and any medications you are taking. During Cycle 1, you will have blood samples (about 1 teaspoon each time) drawn to measure the amount of study drug in your blood at different times. This is called pharmacokinetic (PK) testing. During Cycle 1, you will have a blood sample drawn before receiving the first dose of Triciribine, and then 2, 24, 48, 72 ,and 96 hours after the Day 1 Triciribine dose. If your doctor decides that it is necessary, an additional blood sample will also be drawn between 120 and 144 hours (about 5-6 days) after your Day 1 dose of Triciribine. During Cycle 1, you may also have blood samples (about 1 teaspoon) drawn to measure the action of the study drug in the tumor cells. This is called pharmacodynamic studies (this defines how the drug works on the tumor cells). During Cycle 1, you will have a blood sample drawn (about 1 teaspoon) before receiving the first dose of triciribine and then 2 and 24 hours after the Day 1 triciribine dose. Before receiving each additional cycle, you will have a physical exam, including vital signs. Blood (about 4 teaspoons) will be drawn for routine tests, and urine will be collected. You will be asked about your ability to perform everyday activities. You will have a bone marrow exam (including aspiration and/or biopsy) about every 28 days, in order to check your response. Certain participants who are at risk for involvement of disease in their central nervous system may be required to have repeat lumbar punctures (spinal taps) performed once a week. You may move to a higher dose level after your first cycle of therapy, if that increased dose level is considered safe and the disease is stable or responding to treatment. If, however, you experience serious side effects from the therapy, the doctor may decide to hold any further therapy with Triciribine until those side effects go away, or may decide to stop therapy altogether, if the side effects are intolerable. Depending on how fast the side effects go away, you may be able to re-start your Triciribine infusions at a lower dose. You may continue to receive Triciribine on study with no limit to the number of cycles that you can receive, as long as your doctor finds that you are benefiting from this therapy and you are not experiencing intolerable side effects. On the other hand, you may stop receiving the study drug and be taken off study if it is not effective for you and/or the disease gets worse, you develop another illness that interferes with the ability to safely give you the study drug, or you are unable to tolerate the study drug. If you leave the study for any reason, you will be asked to return for a follow-up visit at the end of therapy (and possibly 30 days after your last dose of Triciribine, if you are not receiving another type of treatment). A physical exam will be performed, and blood (about 2 teaspoons) will be drawn for routine tests, during both of these visits. If you have side effects that are possibly related to the treatment, you may need to have more follow-up visits. Blood (up to 3 tablespoons) may need to be drawn for routine tests at that time. THIS IS AN INVESTIGATIONAL STUDY. Triciribine has been authorized by the FDA for use in research only. Up to 34 patients will take part in this multicenter study. Up to 30 patients will be enrolled at M. D. Anderson. #Intervention - DRUG : Triciribine - 15 mg/m\^2 IV Weekly Over 1 Hour On Days 1, 8, and 15. - Other Names : - Triciribine Phosphate Monohydrate, TCN-PM, VD-0002

#Eligibility Criteria: Inclusion Criteria: * Patients must have relapsed/refractory leukemias for which no standard therapies are anticipated to result in a durable remission. Patients with poor-risk myelodysplasia (MDS) [i.e. refractory anemia with excess blasts (RAEB-1 or RAEB-2) by WHO classification] and chronic myelomonocytic leukemia (CMML) are also candidates for this protocol. * CONTINUATION # 1: Relapsed/refractory leukemias include acute non-lymphocytic leukemia (AML) by World Health Organization (WHO) classification, acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), or chronic myelogenous leukemia (CML) in blast crisis. Patients with agnogenic myeloid metaplasia (AMM) are also eligible; * ECOG performance status of 0- 3; * Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device [IUD], oral contraceptive or double barrier device), and must have a negative serum or urine pregnancy test within 2 weeks prior to beginning treatment on this trial. Nursing patients are excluded. Sexually active men must also use acceptable contraceptive methods for the duration of time on study. Pregnant and nursing patients are excluded because the effects of Triciribine on a fetus or nursing child are unknown; * Must be able and willing to give written informed consent; * In the absence of rapidly progressing disease, the interval from prior treatment to time of study drug administration should be at least 2 weeks for cytotoxic agents, or at least 5 half-lives for noncytotoxic agents. If the patient is on hydroxyurea to control peripheral blood leukemic cell counts, the patient must be off hydroxyurea for at least 48hours before initiation of treatment on this protocol. Persistent chronic clinically significant toxicities from prior chemotherapy must not be greater than grade 1; and * Patients must have the following clinical laboratory values, unless abnormal parameter level is considered related to leukemia: Creatinine (Cr) less than or equal to 2.0 mg/dL, Bilirubin Normal limits (less than or equal to 1.5 * Upper Limit of Normal (ULN) with liver metastases) unless considered due to Gilbert's syndrome, Aspartate aminotransferase (AST) less than or equal to 3.0 * ULN, Alanine aminotransferase (ALT) less than or equal to 3.0 * ULN Exclusion Criteria: * Uncontrolled intercurrent illness including, but not limited to uncontrolled infection, symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; * Active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, or uncontrolled congestive heart failure; and * Patients receiving any other standard or investigational treatment for their hematologic malignancy. ##Sex : ALL ##Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT04459234", "Brief_Title" : "Prospective Multicentre Study of the Use of Ketamine in the Treatment of Refractory Chronic Pain in the French CLCC", "Official_title" : "KETACANCER: Prospective Multicentre Study of the Use of Ketamine in the Treatment of Refractory Chronic Pain in the French CLCC", "Conditions" : ["Cancer", "Chronic Pain", "Neuropathic Pain", "Opioid Use"], "Location_Countries" : ["France"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary The primary objective of this study is to describe the administration practices of the antalgic Ketamine in French CLCC (Centre de Lutte Contre le Cancer) in terms of indication (neuropathic sequelae pains, morphine additional effect or morphine withdrawal, intensity, localisation...) and administration protocol (route, posology, duration, administration sequence, premedication). The secondary objectives are to evaluate in the context of cancer, the analgesic efficacy, the tolerance profile (biological and clinical toxicities) and the quality of life, including anxiety and depression. In addition, the described parameters will be evaluated as safety and efficacy predictive factors of the Ketamine in oncology. Detailed Description Almost 382,000 new cancers have been diagnosed in France in 2018. Regular progresses in their management have improved the overall survival of patients, sometimes with sequelae that may be particularly painful. Thus for 20 to 45% of patients treated for breast cancer, pain persists 5 years later. If remission is a regularly reached target, cancer was also the cause of 157,000 deaths in 2018 in France, preceded by months or years of progression of a chronic disease that regularly causes pain. Pain during cancer (chronic cancer pain for CIM-11) remains a frequent symptom, and its prevalence has slightly changed during the last 20 years. In the European EPIC study, carried out in 2006, 76% of the cancer patients (and 62% of French patients) presented moderate to severe pains linked to cancer, daily for more than half of them. Even when identified, chronic cancer pain is still under-treated in 25 to 60% of cases worldwide, including in the most developed countries. When well-managed, pain's management now allows the relief of almost 80% of patients. Pain's management is based in particular on a precise and adapted use of the different opioids through different routes of administration (oral, transdermal, trans-mucosal, parenteral, etc.). A neuropathic component of pain exists in almost a third of cases and may require specific treatments when opioids are insufficient. In all cases, the treatment is integrated into a multidisciplinary management, in connection with the ongoing oncological treatments, the loco-regional treatments available (radiotherapy, interventional radiology, etc.) and with an adapted psychosocial management. Ketamine is an NMDA receptor antagonist (N-Methyl-D-Aspartate) indicated as a high dose anesthetic. It is used in the context of peri-operative pain for its anti-hyperalgesic properties. These properties have led to its use also in palliative care (outside the marketing authorization \[AMM\]) to treat hyperalgesia linked to the use of high-doses of opioids, as well as depression. For non-cancer pains, ketamine is widely used by centres and consultations specialized in refractory chronic pain management in different pains not relieved by standard treatments: neuropathic pain, fibromyalgia, etc., or even in opioids weaning aid. The bibliographic data are not homogeneous and of low quality. Despite the weakness of the available data, ketamine is widely used in France in chronic pain in situation of therapeutic impasse. The protocols used vary according to the prescribers and services practices: venous route in general, sometimes subcutaneous or even oral; doses varying from 30 to 200 mg / day, infusion duration varying from a few hours to several days, discontinuous administration by cycle or continuous administration, etc. Current knowledge is too limited in oncology to have a consensus on the use of ketamine : * Often retrospective studies with heterogeneous treatment protocols; * Studied populations also heterogeneous, with insufficiently documented indications; * Staff not able to answer adequately the questions raised. This situation largely explains the heterogeneity of the Ketamine practices of use in oncology It is essential to draw up an inventory of the ketamine use by the French CLCCs pain teams and to identify the profile of patients in whom i) the treatment is ineffective and must be avoided regarding toxicities ii) the potential efficacy required further investigations. Built on a methodology close to the OKAPI study, the KETACANCER study will enable to compare indirectly the results of the two studies. To do this, it is proposed to conduct the KETACANCER prospective study in a precise population defined a priori, and corresponding to the following indications: * Neuropathic sequelae pain * Additional effect of morphine * Morphine weaning. #Intervention - DRUG : Ketamine use in CLCC sites (indication and administration protocol) - Collection of information concerning Ketamine use by French CLCCs pain teams (first prescription): 1. Indications : analgesic treatment of cancer chronic pain, analgesic treatment for a post-cancer treatment chronic pain, help for withdrawal from opioid treatment prescribed for a chronic cancer pain 2. Administration protocol: route, posology, duration, administration sequence, premedication 3. Antalgic efficacy 4. Tolerance profile 5. Quality of life, anxiety and depression evaluations

#Eligibility Criteria: Inclusion Criteria: * Patient at least 18 years at the day of consenting to the study * Patient followed for a solid tumour or a hematological malignancy (treated or under treatment) * Patient presenting cancer chronic pain or post cancer treatment pain * Patient followed by a CLCC's intractable chronic pain consultation or centre * Patient with an indication of 1st Ketamine course: * Analgesic treatment of cancer chronic pain * Analgesic treatment for a post-cancer treatment chronic pain * Help for withdrawal from opioid treatment prescribed for a chronic cancer pain * Patient not previously treated by Ketamine * Patient covered by a medical insurance * Patient and/or family did not decline data collection after complete information (information sheet) Exclusion Criteria: * Patient presenting chronic pains not related to cancer or its treatments * Patient with a proven psychotic history * Patient who is not fluent enough in French ##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

{ "NCT_ID" : "NCT05865548", "Brief_Title" : "Addition of Aspirin to Standard of Care in Oral Cancer", "Official_title" : "Randomized Control Trial of Addition of Aspirin to Standard Care in Oral Cancer Patients.", "Conditions" : ["Oral Cancer"], "Interventions" : ["Procedure: Standard of care", "Drug: Aspirin 150 mg"], "Location_Countries" : ["India"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2", "PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary Despite accumulating evidence of the benefit of aspirin in cancer, its effect on improving cancer survival is still debated since the mechanism by which it impacts cancer survival is not completely understood and the published data are discordant. There have been 4 randomized controlled trials (RCT) showing mixed results from no effect to improved survival. Several retrospective and observational studies have reported a survival advantage of adding aspirin to the treatment for various cancers. A meta-analysis of 118 studies, 63 of them specifically reporting on cancer mortality and the rest on all-cause mortality, found a 21% reduction in cancer deaths and about 20% reduction in all-cause mortality (pooled hazard ratio (HR): 0.79; 95% confidence intervals: 0.73, 0.84). However, the evidence is still lacking and there is need to do more RCT Detailed Description Aspirin (ASA), an NSAID, is a well-known antipyretic and analgesic agent and is used to prevent recurrent transient ischemic attacks or strokes. In addition to its classical anti- inflammatory function, clinical and epidemiological studies indicate that aspirin can be used as a preventive or therapeutic agent in multiple cancers, including oral cancers While the exact mechanism through which NSAIDs contribute to chemo prevention is not completely understood, Aspirin inhibits the enzyme Cox; Cox-1 and Cox-2 are well characterized. Cox converts a arachidonic acid to prostaglandin H2, which in turn produces biologically active prostaglandins that influence path physiological processes in a range of tissues including angiogenesis, apoptosis, cell proliferation and migration, inflammatory response and thrombosis. Inhibition of prostaglandin synthesis is considered the pre dominant mechanism by which NSAIDs act as anti-inflammatory agents, but it is unclear whether the anti-cancer properties of these agents can be solely attributed to Cox inhibition. Recently, Cox-2 over expression has been identified in a number of different malignancies and it has been hypothesized that Cox-2 prostaglandins promote tumor genesis by inhibiting apoptosis, modulating the immune system and regulating tumor associated angiogenesis. A detailed search of literature and bio informatics analysis of the data obtained showed that the effect of Aspirin on survival and prevention of recurrence and secondary cancer could be due to its effect on following 11 genes PTGS2, PIK3CA, PARP1, PARP2, VEGFA, KDR, PTGES2, NFKB1, P53, FLT1, VEGFR. These genes not only interact and control each other but also control cell cycle regulation through other genes as shown below. These could be due to co expression, physical interactions, shared domains or predicted interactions in absence of data. Based on the gene-gene and protein-protein interactions they can be clustered into three with PTGES2, PTGS2 and p53 being in first cluster (figure 2 below), the NGS data obtained from the previous patients also showed the p53 to be the primary driver gene (unpublished data, submitted) in nearly 50% of the subjects. It has also been shown that patients with p53 mutations have poor survival and increased recurrence rates compared to those without p53 mutations. This coupled with literature showing improved survival and low recurrence in patients receiving Aspirin suggest the need for a RCT as this has never been done before. #Intervention - DRUG : Aspirin 150 mg - Aspirin 150 mg PO daily - PROCEDURE : Standard of care - Surgery with or without radiation, palliative chemo as per investigators choice - Other Names : - Radiation, chemotherapy

#Eligibility Criteria: Inclusion Criteria: * All Histologically proven cases of primary oral cancers. * Stage T1 to T4, N0 to N3, M0 to M1. * Age above 18. * Karnofsky' performance status more than 70, ECOG 0 to 2 * Hb >8.0 gm/dL * Total count >4000 cu mm * Platelet count >100000 Serum creatinine <1.0mg * Liver enzymes up to 1.5 times normal * Bilirubin <1.0mg Exclusion Criteria: * Patients with acid peptic disease * Pregnant and lactating women. * Patients not willing to participate. * Patients with known allergy to NSAID * Patients with Asthma, rhinitis and nasal polyps * Presence of viral fever * Use of any other blood thinner like warfarin, heparin or low molecular weight heparin * bleeding/blood-clotting disorders (such as hemophilia, vitamin K deficiency, low platelet count) * pyruvate kinase or G6PD deficiency * Patients receiving mifepristone, acetazolamide, corticosteroids, dichlorphenamide, methotrexate, valproic acid, herbal medications (such as ginkgo biloba) * Patients with recent history of anti-viral vaccines ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Maximum Age : 99 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03850132", "Brief_Title" : "Family Cancer Caregivers Receiving a Specific Supportive Care Intervention Pre- and Postloss", "Official_title" : "The Effect of Receiving a FAM-SOTC Intervention Before and in the Bereavement Phase (FAM-SOTC-PL) on Bereaved Family Cancer Caregivers Outcomes: A Quasi-experimental Study", "Conditions" : ["Bereavement"], "Interventions" : ["Behavioral: FAM-SOTC-PL"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Background and study aims The effect of cancer caregiving may have profound impact on the psychosocial health of family caregivers and become evident after loss. Grief following the loss of a close relative is one of the most emotional challenging experience faced by family caregivers. Providing a family based intervention before and after a close relatives´death may positively impact bereavement outcomes. This study aims to assess the impact of a continuing specific supportive care intervention on bereaved family caregivers grief response scores and psychological distress following the loss of a close relative when offered before and after death because of cancer. Detailed Description This clinical trial is part of a broader research study (registered trial intervention ISRCTN21786830) which aimed to evaluate a palliative care nurse-led family-oriented intervention Family-Strengths Oriented Therapeutic Conversation (FAM-SOTC) to support family caregivers of a close relative with advanced/final stage cancer, in the context of the family when receiving specialized palliative home-care. The purpose of the current trial is to investigate the effects of the FAM-SOTC intervention when additionally delivering the third session of the intervention in this trial; an adapted version; FAM-SOTC Post-Loss and repeated post-intervention measures at 3, 5 and six months post-loss completed by bereaved family caregivers who have prior participated in the FAM-SOTC trial intervention pre-loss are compared to measures at 3, 5 and six months post-loss among bereaved family caregivers in a control group who received usual care pre- and post-loss from the palliative home-care unit. The FAM-SOTC intervention and the FAM-SOTC Post Loss intervention is delivered simultaneously in two separate clinical trials, where two sessions were delivered pre-loss (FAM-SOTC) and one session delivered post-loss (FAM-SOTC-PL). #Intervention - BEHAVIORAL : FAM-SOTC-PL - The adapted FAM-SOTC-PL intervention was delivered at the home of the participants and focuses on supporting the effective, cognitive, and behavioural domains of the bereaved family caregivers experience by targeting concerns/issues in these categories. The FAM-SOTC-PL comprises of the following five components: 1. Drawing forward narratives about the pre- and post-loss experience. 2. Asking therapeutic/interventive questions, emphasising on the most pressing concerns also assessing health issues. 3. Validating/acknowledging emotional responses. 4. Assessing the need for specific information and recommendations regarding bereavement. 5. The use of commendation/commending strengths, by focusing on and affirming the strengths of the family caregiver.

#Eligibility Criteria: Inclusion Criteria: * The eligibility criteria is that the primary family caregivers (who had been identified by the patient pre-death) are aged >= 18 years, bereaved due to cancer and that three months have passed since the deceased has died. Additional inclusion criteria is that the family caregivers have received care from a specialised palliative home-care unit at a university hospital in the advanced and final stage of their close relatives´ cancer trajectory. Exclusion Criteria: * Non cancer and not being participating in another family level psycho-social intervention research. ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: Yes

{ "NCT_ID" : "NCT01124994", "Brief_Title" : "Confocal Laser Endomicroscopy and Endoscopic Mucosal Resection", "Official_title" : "Endomicroscopy-targeted Endoscopic Mucosa Resection for Barrett's Oesophagus-associated Neoplasia", "Conditions" : ["Barrett's Mucosa With High Grade Intraepithelial Neoplasia (HGIEN)"], "Interventions" : ["Procedure: Endoscopic mucosal resection"], "Location_Countries" : ["Austria"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The accurate detection and therapy of adenocarcinoma originating from Barrett's oesophagus is challenging as current endoscopic techniques are unreliable for both the detection of high grade intraepithelial neoplasia (HGIN) within Barrett's mucosa and the correct measurement of the dimension of such neoplastic lesions. Confocal laser endomicroscopy (CLE) is a promising technology that could help to close this gap. Relying on first clinical trials of CLE, which showed remarkable results for the detection of Barrett's associated neoplasia, the investigators want to use CLE as targeting tool for endoscopic mucosal resection of HGIN in patients suffering from Barrett's oesophagus. CLE-mapping of neoplastic lesions will be documented and compared to the later performed histological evaluation of the resected specimen. If CLE is passing our challenge this will be another valuable proof of its high potential as reliable new endoscopic technology. Its usage could increase the en-bloc resection rate and decrease the amount of repetitive resections, which would remarkably improve the patients comfort. Detailed Description Introduction Barrett's oesophagus is a common complication in patients suffering from gastro-oesophageal reflux disease (GERD). By means of chronic acid exposure the squamous epithelium of the oesophagus turns into a specialised columnar epithelium (SCE) with goblet cells. This histological change is prevalent in 1% of the normal population, and in up to 4, 9% of patients with reflux symptoms \[1\]. Although the Barrett's epithelium itself does not necessarily cause additional symptoms, its presence has to be diagnosed accurately, since affected patients are at increased risk of 0.5% per year of developing Barrett's associated cancer. An important prognostic factor is made up by the grade of dysplasia within the Barrett's mucosa. While most patients with no dysplasia or low-grade dysplasia remain clinically inconspicuous, the annual risk of developing cancer is up to 10% in those patients with high-grade dysplasia. If a Barrett's associated neoplastic lesion is found during endoscopy, Barrett's associated cancer is also present at another site of Barrett's oesophagus in up to 30% \[2\]. Consequently, they undergo periodically screening, consisting of endoscopy of the oesophagus with 4-quadrant biopsy every 2 to 3 cm or, in case of HGIN, local ablative therapy. The time period between controls depends on the grade of dysplasia diagnosed at upper gastrointestinal endoscopy. If no dysplasia is present, the recommended follow-up period is less than 5 years. In case of low grade dysplasia endoscopic controls should be performed every year. Patients with high grade dysplasia should be examined every 3 months or prepared for a therapeutic intervention \[3\]. Early detection of Barrett's associated neoplasms, which can be histologically classified as adenocarcinoma, has important therapeutic implications. Cancerous infiltration of submucosal structures is associated with a significant risk of lymph node metastases and should be therefore treated by surgery. However, oesophagectomy has been shown to suffer from mortality rates between 3 and 12%, apart from substantial short- and long-term morbidity. Hence it is essential to detect early neoplastic lesions to have a broader range of therapeutic options at disposal. Patients with high grade intraepithelial neoplasia (HGIN) or mucosal cancer are perfect candidates for curative endoscopic interventions like endoscopic ablation (with radiofrequency, for example), endoscopic submucosal dissection (ESD) or endoscopic mucosal resection (EMR). The latter techniques are preferred as the resected specimens can be evaluated histologically, which provides definite information about the invasion depth and whether the resection borders are free from neoplastic tissue. Because of high rates of newly occurring neoplasia, remaining areas of Barrett's mucosa should be ablated or resected after histological confirmation of Barrett's oesophagus associated neoplasia \[3, 4\]. Trying to improve the diagnostic yield in the surveillance of patients with high risk for Barrett's oesophagus associated neoplasia, many new endoscopic inventions have been introduced into the management of Barrett's oesophagus in order to optimize the detection rates of early lesions. Among those are developments that improved the image quality of conventional white light endoscopes like high-resolution and high-definition endoscopes. Another approach, called chromoendoscopy, uses in vivo staining with methylene blue, indigo carmine or acetic acid. These dyes help to increase the tissue contrast which leads to improvement of detection rates comparable to high-resolution endoscopy. High contrast levels without staining agents can be achieved by the use of narrow band imaging (NBI). This technology additionally improves the visibility of capillaries, veins and other subtle tissue structures by the use of light with wavelength restricted to small bands in the blue and green spectrum. In a prospective randomized crossover study it showed equal results to high-resolution endoscopy plus indigo carmine \[4, 5\]. The newest development that has been introduced in the endoscopic management of the gastrointestinal tract is the so called confocal laser endomicroscope (CLE). Confocal microscopy was developed by Marvin Minsky in the late 1950s. Its principle is the microscopic scanning of focal points below the surface of an object. In comparison to conventional light microscopy it uses a special filter system to avoid image overlapping by surrounding tissue. In detail, a light source (normally a laser) is focused by a microscope objective lens to a diffraction limited spot on or inside the object. Light that is scattered, or fluorescence excited (achieved through fluorescein staining, for example) and emitted, at the focus in the sample will partially return back through the optics along the path from which it arrived. A beam-splitter placed into the path reflects the return light towards a detector. The optics will focus the light from the focal point in the specimen to its conjugate focus near the detector (hence the technology is termed 'con-focal'). Here a spatial filter ('pinhole') is used to extinguish all light deriving from areas outside the focal point. Light reflections from the focal point itself will be forwarded to the detector which is connected to a computer system that digitalises the optical signal and creates the in vivo histological image \[6\]. Focussing on its clinical impact, confocal microscopy is the first technique to allow in vivo evaluation of tissue structures beneath their surface. Because of many breakthroughs in miniaturisation (mostly in the 1990s) this technology could be applied for intraluminal use in gastroenterology, integrated into a otherwise standard endoscope. It allows the in vivo histological visualisation of the upper 250 micrometers of all walls within the gastrointestinal tract, additionally to the normal function of white light endoscopy (provided by two separate screens on top of the workstation) \[6\]. Using CLE in a first clinical approach, Kiesslich et al. found high sensitivity and specificity rates for the detection of Barrett's oesophagus as well as for the prediction of Barrett's associated neoplastic changes - for both results CLE derived pictures were compared to conventional histology \[7\]. In a first prospective, randomized, double-blind, controlled, crossover trial Dunbar et al. proved these findings, as CLE-targeted biopsies had a higher diagnostic yield for Barrett's oesophagus associated neoplasia than standard endoscopy with 4-quadrant random biopsy \[8\]. Study Aims In our clinical investigation we want to use confocal laser endomicroscopy (CLE) to accurately target Barrett's oesophagus associated neoplasia for subsequent endoscopic mucosal resection (EMR). To our knowledge this combination is only documented in one case report so far, describing the successful resection of a high-grade dysplastic Barrett-segment by the use of CLE-targeted EMR \[9\]. We want to show that CLE is suitable to detect the exact borders of high grade intraepithelial neoplasia. In our experience this feasibility cannot be reliably provided by any other established technique like chromoendoscopy or narrow band imaging, which often causes the need for re-treatment or even surgery. To guarantee accurate documentation of mucosal CLE-mapping, the dimensions of the neoplastic lesion will be marked in terms of colour, photographed by simultaneously available white light endoscopy and finally evaluated by histological assessment of the specimen. Analysing the borders of the resected specimen in concern of tumour infiltration we will be able to calculate the en-bloc resection rate of CLE-targeted EMR. In order to evaluate CLE concerning true negative results we will resect all remaining mucosal areas affected by Barrett within the second phase of the examination or (if the lesions are too big for one-time resection) within a second examination. Once again, CLE will be applied for all lesions to search for malignancies. If CLE detects further areas of neoplasia, CLE-mapping as mentioned above will be performed. All resected tissue parts will be evaluated histologically to check the results of CLE. If CLE provides reliable data in our investigation this would be a big step on the way to establishing this new technology within the pre-interventional endoscopic management of patients suffering from Barrett's oesophagus. This could help to increase the en-bloc resection rate, decrease the amount of repetitive resections and consequentially improve the patients comfort. Study Design Prospective clinical trial without randomisation or blinding Study Population Patients referred to our department for endoscopic mucosal resection (EMR) of Barrett's mucosa with high grade intraepithelial neoplasia (HGIN) that has been detected during routine upper endoscopy or Barrett's surveillance endoscopy at our department or at another hospital. Exclusion criteria: * patients allergic to one of the drug components (including drugs used for conscious sedation like propofol or midazolam as well as fluorescein, the fluorescent dye used for CLE ) * patients presenting with contraindications to EMR (low platelet count, therapeutic anticoagulation, coagulation disorders) * refusal to participate in the study Methods Our investigation will be performed at the Medical University of Vienna, department of medicine III, clinical division of gastroenterology and hepatology. Patient recruitment will start on the 1st of July 2010. The study will last for two years. The number of patients included within this period will be 40, based on the current number of EMR performed at our department for Barrett's with intraepithelial neoplasia. All patients who fulfil the listed inclusion criteria, will receive the patient information form of this study together with the usual informed consent form of the respective endoscopic examination they are about to undergo. Patient information will be done at least 24 hrs. before the intervention, as practised at our unit. If the patient agrees to participate in the study he will be prepared for endoscopy with our confocal laser endomicroscope (Pentax EC3870K with the ISC-1000 confocal endomicroscopy processor - Pentax, Tokyo, Japan and Optiscan Pty Ltd, Notting Hill, Victoria, Australia) by administration of intravenous propofol and/or midazolam as routinely used for conscious sedation during endoscopic procedures at our department. Additionally, 5-10 ml of a 10% solution of fluorescein sodium will be administered intravenously to enhance tissue fluorescence during endomicroscopy. All drugs will be administered by medical specialists (such as the project director), assistant doctors (such as the project assistant) or registered nurses, as routinely practised at our institution. Ethical implications Confocal laser endomicroscopy is a safe new technique that has already been studied in clinical trials \[7, 8\]. Its safety is being guaranteed by the use of low intensity laser light that can at worst cause local bleaching of fluorescein containing cells, which is harmless, reversible and even used as diagnostic sign in experimental conditions \[6\]. Endoscopic mucosal resection is a well established technique for the minimal invasive, non-surgical curative treatment of intramucosal neoplasia. It has been studied in many clinical trials and is routinely performed at our unit for lesions in the oesoophagus, the stomach, duodenum and colo-rectum. Although severe complications like prolonged bleeding or perforations can potentially occur, the risk/benefit profile of this procedure is very good, compared to surgical treatments of neoplastic diseases of the oesophagus \[10\]. This study protocol has been submitted to the ethic commission of the Medical University of Vienna (EK-Nr. 697/2009) and was handled at the meeting on the 8th of September 2009. A positive vote was already delivered to our institution in written form. #Intervention - PROCEDURE : Endoscopic mucosal resection - Confocal laser endomicroscopy will be used to target endoscopic mucosal resection of Barrett's oesophagus-associated neoplasia

#Eligibility Criteria: Inclusion Criteria: * Patients referred to our department for endoscopic mucosal resection (EMR) of Barrett's mucosa with high grade intraepithelial neoplasia (HGIN) that has been detected during routine upper endoscopy or Barrett's surveillance endoscopy at our department or at another hospital. Exclusion Criteria: * patients allergic to one of the drug components (including drugs used for conscious sedation like propofol or midazolam as well as fluorescein, the fluorescent dye used for CLE ) * patients presenting with contraindications to EMR (low platelet count, therapeutic anticoagulation, coagulation disorders) * refusal to participate in the study ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Maximum Age : 90 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03427671", "Brief_Title" : "OCL 500 Treatment of Women With Symptomatic Uterine Fibroids", "Official_title" : "An Open Label, Single Center Study to Evaluate the Safety and Effectiveness of OCL 500 Embolization Microspheres (OCL 500) in Uterine Artery Embolization for the Treatment of Premenopausal Women With Symptomatic Uterine Fibroids", "Conditions" : ["Uterine Fibroid", "Myoma", "Leiomyoma"], "Interventions" : ["Device: Occlusin 500 Microspheres"], "Location_Countries" : ["Canada"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This is a prospective, open-label, single-arm, safety and effectiveness study of Occlusin 500 microspheres in women with symptomatic uterine fibroids. Detailed Description Prior to entering the study, all patients will undergo pre-study assessments including compliance with inclusion and exclusion criteria, laboratory assessments, pelvic examination, and imaging of the pelvis. Following conventional catheter angiography to confirm catheter placement and the uterine vasculature, each patient will undergo transarterial embolization with Occlusin 500 microspheres. #Intervention - DEVICE : Occlusin 500 Microspheres - Occlusin 500 microspheres will be administered using a catheter directed to the uterine vasculature using fluoroscopy. The microsphere suspension will be administered to a near-stasis endpoint.

#Eligibility Criteria: Inclusion Criteria: * Premenopausal women with symptomatic uterine fibroids * Willing and able to provide informed consent * Fibroids visible by ultrasound or non-contrast magnetic resonance imaging * Fibroids with a minimum diameter of 4cm for a single fibroid or 3cm where there are 2 or more fibroids; minimum total fibroid burden 33cc * Documented ovulation by Luteinizing Hormone (LH) testing * Follicle Stimulating Hormone (FSH) value >40 IU/L within 3 months prior to procedure * Pelvic examination within 6 months prior to procedure * Normal Pap smear Exclusion Criteria: * Positive pregnancy test * Uterine size > 20 weeks gestation * Fibroids that are more than 50% submucosal * Individual fibroids > 12cm in diameter, or total fibroid burden > 905cc * Pedunculated subserosal fibroids with an attachment to the uterus less than 50% of the greatest diameter of the fibroid * Fibroids situated in the cervix * Abnormally large ovarian arteries * Uterine pathology other than fibroids * History of gynecologic malignancy * Active pelvic infection or history of pelvic inflammatory disease * Undiagnosed pelvic mass outside the uterus * History of chemotherapy or radiation to the abdomen or pelvis * Intra-Uterine Device (IUD) in position * History of, or ongoing, hemolytic anemia * Severe cerebrovascular disease defined by a cerebrovascular accident within 6 months of treatment * Anticoagulant therapy or known bleeding disorder * Treatment with Gonadotropin Releasing Hormone (GnRH) agonists within the previous 6 weeks * Received another investigational agent within past 12 weeks * Compromised hematopoietic function * Compromised hepatic function * Compromised renal function * BMI > 38 * Claustrophobia * Contraindication to angiography * Contraindication to magnetic resonance imaging (MRI) or MRI contrast agents * Allergy to contrast agents * Allergy to bovine collagen * Patient desires to become pregnant, or does not agree to contraception during study ##Sex : FEMALE ##Ages : - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD, OLDER_ADULT ##Accepts Healthy Volunteers: Yes

{ "NCT_ID" : "NCT02367196", "Brief_Title" : "A Phase 1, Dose Finding Study of CC-90002 in Subjects With Advanced Solid and Hematologic Cancers", "Official_title" : "A Phase I, Open-Label, Dose Finding Study of CC-90002, a Monoclonal Antibody Directed Against CD47, in Subjects With Advanced Solid and Hematologic Cancers", "Conditions" : ["Hematologic Neoplasms"], "Interventions" : ["Drug: CC-90002", "Drug: Rituximab"], "Location_Countries" : ["United States", "Spain"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary CC-90002-ST -001 is an open-label, Phase 1, dose escalation clinical study in subjects with advanced, refractory solid and hematologic cancers. Detailed Description CC-90002-ST-001 is an open-label, Phase 1, dose escalation, first in human (FIH) clinical study of CC-90002, administered by intravenous (IV) infusion, in subjects with advanced, refractory solid and hematologic cancers. The study will be conducted in two parts. Part A dose escalation phase will explore escalating dose cohorts of the study drug CC-90002. Part B dose escalation will explore escalating doses of CC-90002 in combination with rituximab in subjects with CD20-positive NHL. #Intervention - DRUG : CC-90002 - DRUG : Rituximab

#Eligibility Criteria: Inclusion Criteria: * Men and women, >= 18 years, with advanced, relapsed or refractory solid tumors, Multiple Myeloma (MM) or non-Hodgkin's lymphoma (NHL) in Part A. In Part B, relapsed and/or refractory CD20-positive NHL subjects only. * At least one site of measurable disease in subjects with solid tumors and NHL. * Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. * Subjects must have adequate hematopoietic, liver, renal and coagulation function as assessed by specific laboratory criteria. * Females and males must agree to contraceptive methods and avoid conceiving throughout the study, and for up to 8 weeks following the last dose of CC-90002. If participating in Part B, females of child bearing potential should continue to use effective contraceptive methods for 12 months following treatment with rituximab Exclusion Criteria: * High grade lymphomas (Burkitts or lymphoblastic), plasma cell leukemia. * High grade, rapidly proliferative solid tumors (eg, small cell lung cancer, germ cell tumors, neuroblastoma) with extensive tumor burden. * Symptomatic central nervous system involvement. * Impaired cardiac function or clinically significant cardiac disease. * Prior Red blood cell (RBC) transfusion < 3 months prior to starting CC-90002 (Part A only). * Prior autologous stem cell transplant <= 3 months prior to starting CC-90002. * Prior allogeneic stem cell transplant with either standard or reduced intensity conditioning <= 6 months prior to starting CC-90002. * Prior systemic cancer-directed treatments or investigational modalities <= 5 half lives or 4 weeks prior to starting CC-90002, whichever is shorter. * Major surgery <= 2 weeks prior to starting CC-90002. * Pregnant or nursing females. * Known HIV infection. * Known chronic, active hepatitis B or C (HBV/HCV) infection. * Ongoing treatment with chronic, therapeutic dosing of anti-coagulants. * History of autoimmune hemolytic anemia or autoimmune thrombocytopenia. * History of concurrent second cancers requiring active, ongoing systemic treatment. concurrent second cancers requiring active, ongoing systemic treatment. ##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

{ "NCT_ID" : "NCT00241384", "Brief_Title" : "Low Dose Supplemental External Radiation With Pd-103 Versus Pd-103 Alone for Prostate Cancer", "Official_title" : "Low Dose Supplemental External Radiation With PD-103 Versus PD-103 Alone For Prostate Cancer", "Conditions" : ["Prostate Cancer"], "Interventions" : ["Procedure: Pd-103", "Procedure: External beam radiation"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The primary purpose of this study is to evaluate two treatment regimens for prostate cancer, prostate implant with 20 Gy of external beam radiation therapy versus prostate implant with 0 Gy of external beam radiation therapy. Patients diagnosed with intermediate risk prostate cancer between the ages of 40 and 80 who have chosen brachytherapy with or without external beam radiation therapy as their intended treatment will be eligible and will be offered participation. Detailed Description Approximately 250,000 men are currently diagnosed with prostatic cancer in the United States each year. Of those, 70% have stage T1 or T2 disease (apparently limited to the prostate gland). Clinically localized prostate cancer is a spectrum of disease, ranging from good prognosis to poor prognosis. Patients with a PSA above 10 ng/ml or Gleason score of 7 to 10 are referred to as intermediate risk, with approximately an 80% chance of cure. Implantation of radioactive sources directly into the prostate (brachytherapy) delivers a high, localized radiation dose while sparing most the of the bladder and rectum. Brachytherapy is well established for other tumor sites, and has become a standard treatment for prostate cancer. Establishing that a good quality implant alone is as effective as implant plus beam radiation will allow us to routinely drop the use of beam radiation, a change in policy that will decrease the risk of some complications, will be more convenient for patients, and will lower treatment costs. #Intervention - PROCEDURE : External beam radiation - PROCEDURE : Pd-103

#Eligibility Criteria: Inclusion Criteria: * Patients with previously untreated prostatic cancer. * Must have PSA 10 <= age <= 20 ng/ml, Gleason 7 to 9 Exclusion Criteria: * Patients with proven regional lymph node involvement will be excluded. ##Sex : MALE ##Ages : - Minimum Age : 40 Years - Maximum Age : 80 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01015820", "Brief_Title" : "Early Increase in Blood Flow (EIBS) in the Duodenum in Patients With Pancreatic Cancer", "Official_title" : "Detectable Early Increase in Blood Flow (EIBS) in the Duodenum in Patients With Pancreatic Cancer", "Conditions" : ["Pancreatic Cancer"], "Interventions" : ["Procedure: EGD with EUS", "Device: 4D-ELF"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary Pancreatic cancer is the fourth leading cause of cancer death in the United States and is associated with a poor prognosis. The average life expectancy after diagnosis is approximately 5 to 8 months. At present, successful surgical resection is the only curative therapy that can improve long-term survival. However, it can be achieved only when a tumor is detected at an early stage. Unfortunately, due to non-specific symptoms associated with pancreatic cancer, it is commonly detected in the later stages of the disease. The investigators hypothesized that pancreatic cancer could be detected by measuring the changes in the early increase in blood supply (EIBS) found in the surrounding normal-appearing duodenal tissue. The investigators tested a device called Four-dimensional Elastic Light-Scattering Fingerprinting (4D-ELF). The device used in this study is considered investigational, which means it has either not been approved by the Food and Drug Administration (FDA) for routine clinical use or for the use described in this study. However the FDA allowed the use of this device in this research study. Detailed Description According to field effect theory, by detecting microvasculature changes in the early increase of blood supply in the surrounding tissue neoplastic lesions can be identified from a distance. The objective of this study was to determine the feasibility and efficacy of a fiberoptic probe containing novel Polarization Gating Spectroscopy (PGS) technology to identify patients with pancreatic adenocarcinoma (PAC) by field effect theory. EIBS markers, deoxyhemoglobin concentration (DHb), and average blood vessel radius (BVR) were evaluated in patients with PAC versus controls. During the subjects' esophagogastroduodenoscopy (EGD) with upper endoscopic ultrasound (EUS), the new optic probe was inserted inside the endoscope and advanced to the tip of the endoscope prior to the scope being withdrawn. As the scope was withdrawn, the light optic probe was used to examine approximately 5 sections of the small bowel: 1) directly on the ampulla, 2) approximately 5 mm proximal from the ampulla, 3) approximately 5 mm distal from the ampulla, 4) 1 cm proximal from the ampulla, and 5) 1 cm distal from the ampulla. Spectroscopy measurements were obtained four times in each of these five peri-ampullary locations. The rest of the EGD and upper EUS endoscopy procedures were then completed as clinically indicated. During the procedure, all visualized mucosal abnormalities were recorded and photographed. #Intervention - PROCEDURE : EGD with EUS - EUS was performed in order to measure blood flow in duodenum. - DEVICE : 4D-ELF - During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.

#Eligibility Criteria: Inclusion Criteria: * Age >= 18 years. * Informed written consent. * Patient scheduled for previously planned EGD with upper EUS * Patients with known adenocarcinoma of the pancreas included in the cancer group * Patients with abdominal imaging studies (e.g., CT abdomen or MRI abdomen) negative for malignancy in past 5 years included in the control group. Exclusion Criteria: * Unable to obtain biopsy specimen or fine-needle aspiration results of the pancreas lesion (e.g., coagulation disorder, inadequate sample) * Presence of malignant lesion in the pancreas or duodenum other than pancreas adenocarcinoma (e.g., neuroendocrine tumor, gastrointestinal stromal tumor) * Known familial disorder with high risk of pancreas cancer development (e.g., familial adenomatous polyposis syndrome, hereditary non-polyposis colorectal cancer syndrome, juvenile polyposis syndrome) * Significant family history of pancreatic cancer (at least one first degree relative with pancreatic cancer) * Presence of premalignant lesions (e.g., duodenal adenoma, pancreas intraductal papillary mucinous neoplasm) * Active visible inflammation/ulcer in the stomach or the duodenum * Patients with known chronic pancreatitis were excluded from cancer group. Chronic pancreatitis patients were allowed to be included in the control group only. * Known pregnancy or sexually active females of childbearing age who are not practicing an accepted form of birth control. ##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

{ "NCT_ID" : "NCT00343356", "Brief_Title" : "Intravesical Epirubicin Plus BCG to Prevent the Recurrence of Transitional Cell Carcinoma of Bladder", "Official_title" : "Clinical Study of Intravesical Epirubicin Plus BCG to Prevent the Recurrence of Transitional Cell Carcinoma of Bladder After Surgical Management", "Conditions" : ["Bladder Neoplasms"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "PREVENTION", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary Biochemotherapy (combined immunotherapeutic drugs and chemotherapeutic drugs) has shown virtue than that use chemical or biological drugs alone in the treatment of some malignant tumor. Here we investigated the efficacy of sequential intravesical therapy with EPI and BCG to EPI or BCG alone in patients with transitional cell carcinoma of bladder cancer after surgical management. Detailed Description Methods From July 1996 to November 2003, a total of 138 cases of bladder cancer underwent TURBT or partial cystectomy were entered the trail. They were divided into 3 groups randomly: 1, EPI plus BCG; 2, use BCG alone; and 3, use EPI alone. All the patients have been followed up for 28-40 months after surgery (average time was 36 months), and the frequency of bacterial, chemical cystitis and other local side effects were also observed.Results After a median follow up of 36 months, the number of recurrences in group 1 was significantly reduced than group 2 and 3 (p\<0.05 vs group 2 and 3, x2-test). The frequency of bacterial, chemical cystitis and other local side effects was similar in group 1 and 2, whereas significant severe side effect was found in group 3 (p\<0.05 vs group 2 and 1, x2-test). Allergic reactions, including skin rash, were more frequent in group 3, and other systemic effects were more frequent in group 1. Conclusion Biochemotherapy by single dose EPI plus sequential BCG intravesical is markedly effect in preventing the recurrence of bladder cancer after surgical management. Its side effects are low. This method is of high clinical value. #Intervention - DRUG : Trement

#Eligibility Criteria: Inclusion Criteria: * primary single or multiple (more than 2 tumors) pTa to pT1 transitional cell carcinoma, solitary or multiple grade Ⅲ tumors and primary or concomitant carcinoma in situ of the bladder were included in the study Exclusion Criteria: * Previous radiotherapy, intravesicial or systemic chemotherapy within 3 months of the study, presence of a second primary malignancy and transitional cell carcinoma of the upper urinary tract or prostatic urethra, invasion of periurethral prostatic ducts, prostatic gland or stroma were exclusion criteria ##Sex : ALL ##Ages : - Minimum Age : 26 Years - Maximum Age : 72 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03411980", "Brief_Title" : "Pharmacokinetics and Safety of Vilaprisan in Renal Impairment", "Official_title" : "An Open-label, Single-dose Study to Evaluate the Pharmacokinetics and Safety of Vilaprisan in Subjects With Decreased Renal Function in Comparison With Matched Subjects With Normal Renal Function", "Conditions" : ["Uterine Fibroids", "Endometriosis"], "Interventions" : ["Drug: Vilaprisan (BAY1002670)"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "OTHER", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of the study is to evaluate the pharmacokinetics of vilaprisan in subjects with moderate to severe renal impairment compared with matched subjects with normal renal function. Detailed Description This is a multiple-center, open-label, non-randomized, single-dose study in 3 parallel groups of subjects with moderately or severely impaired renal function or normal renal function matched with regard to sex, age, race and weight. PK blood and urine sampling for determination of vilaprisan concentrations in plasma and urine, respectively, will be preformed at pre-defined time points up to 14 days post-dose. Safety and tolerability will be assessed through adverse events, clinical laboratory tests, vital signs, 12-lead electrocardiograms and physical examinations. #Intervention - DRUG : Vilaprisan (BAY1002670) - Single oral dose (1 x 2 mg immediate-release, film-coated tablet)

#Eligibility Criteria: Inclusion Criteria: * BMI: 18 to 40 kg/m*2 (inclusive) * Decreased renal function, as assessed at screening, based on serum creatinine and calculated according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula, either: Moderately impaired renal function: eGFR: 30 to 59 mL/min/1.73 m*2; or Severely impaired renal function: eGFR <30 mL/min/1.73 m*2 but not on dialysis * Normal renal function, as assessed at screening and based on serum creatinine according to the CKD-EPI formula: eGFR >=90 mL/min/1.73 m*2 Exclusion Criteria: * Any relevant disease within 4 weeks prior to study drug administration including infections and acute gastrointestinal diseases (vomiting, diarrhea, constipation) requiring medical treatment. * Severe cerebrovascular or cardiac disorders less than 6 months prior to study drug administration, e.g. stroke, myocardial infarction, unstable angina pectoris, percutaneous transluminal coronary angioplasty or coronary artery bypass graft, congestive heart failure of Grade III or IV according to New York Heart Association, or arrhythmia requiring antiarrhythmic treatment. * Malignancy diagnosed or treated within the past 5 years. This does not include adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin. * Acute renal failure or acute nephritis within the past 2 years. * Pregnancy or lactation. * Use of CYP3A4 inducers from 2 weeks before study drug administration until last day of blood sampling for PK after study drug administration, including grapefruits. * Insufficiently controlled diabetes mellitus with fasting blood glucose >220 mg/dL or HbA1c >10%. ##Sex : ALL ##Ages : - Minimum Age : 18 Years - Maximum Age : 79 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: Yes

{ "NCT_ID" : "NCT02618161", "Brief_Title" : "Timing of HDR With EBRT in Localised Prostate Cancer,Toxicity and Quality of Life Assessment", "Official_title" : "A Randomised Feasibility Trial to Investigate the Timing of HDR Brachytherapy With EBRT in Intermediate and High Risk Localised Prostate CAncer Patients and Its Effects on Toxicity and Quality of Life", "Conditions" : ["Prostate Cancer"], "Interventions" : ["Radiation: External beam Radiotherapy", "Radiation: HDR Brachytherapy"], "Location_Countries" : ["United Kingdom"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "SINGLE" } }

#Study Description Brief Summary TITLE Timing of HDR brachytherapy with EBRT in intermediate and high risk localised Prostate CAncer patients and its effects on Toxicity and Quality of life - randomised feasibility trial. SHORT TITLE THEPCA trial Protocol Version Number and Date Version 2.1, dated 16 DEC 2014 Study Duration Recruitment Duration 18-24 months Study Centre Southend University Hospital NHS Foundation Trust Objectives Assessment of acute toxicities: Genitourinary, gastrointestinal and sexual dysfunction at various time points. Number of Participants 50 participants Main Inclusion Criteria * Patient age \>18 years * Histologically diagnosed Prostate cancer, stages T1b-T3bN0M0 * Any Gleason score * Any PSA level * Patient able to consent and fill in the questionnaires Exclusion Criteria - Previous TURP/HoLEP Laser Prostatectomy * Any Metastatic Disease * IPSS\>20 * Pubic arch interference * Lithotomy position or anaesthesia not possible * Rectal fistula * Prior pelvic radiotherapy Statistical Methodology and Analysis Percentages of adverse events will be compared using Fisher's Exact Test. Toxicity score means will be compared using two-sample permutation t-tests, and PSA relapse-free survival will be estimated using Kaplan-Meier and compared using log-rank tests. Detailed Description The role of radiotherapy in management of prostate cancer significantly changed over the last few decades with the developments in Brachytherapy, External Beam Radiotherapy (EBRT), Intensity modulated Radiotherapy (IMRT) and Image guided Radiotherapy (IGRT). One of the challenging factors of Radiotherapy treatment of localised prostate cancer is acute and late Genitourinary and Gastrointestinal toxicities. There are several studies and case series published in literature assessing the toxicities developed during EBRT and Brachytherapy treatment for prostate cancer EBRT and Brachytherapy emerged as the main stay of localised prostate cancer treatment in recent years. The low risk localised prostate cancers can be treated with low dose brachytherapy or by prostatectomy, whereas the intermediate and high risk localised prostate cancers are usually treated with EBRT alone or along with HDR brachytherapy. The recent European guidelines suggest that there is no consensus regarding the timing of HDR brachytherapy and EBRT. The schedules vary in different institutions where HDR boost can be given either before or after EBRT. Few centres deliver HDR in-between the fractions of EBRT. The EBRT doses range from 37.5Gy in 15 fractions to 45Gy in 25 fractions when given with HDR. The total HDR brachytherapy dose can be delivered in fractions, however a single dose of 15Gy is gaining acceptance across the world due to its logistical advantage. The Time gap between the two Radiotherapy modes of delivery is generally within 21 days. There is no consensus about the timing of HDR brachytherapy (BT) when treated along with EBRT. The advantages of using HDR Brachytherapy before EBRT are that the investigators could potentially identify patients who are not suitable for brachytherapy early in the treatment process. It is essential to know whether there is any significant difference in toxicities and treatment outcome especially acute urinary toxicity amongst the two treatment approaches. It will be done by a simple 1:1 ratio randomisation which will only be possible if a participant meets the inclusion and exclusion criteria. Brachytherapy procedure Procedure will be carried out at the surgical theatres in Southend University Hospital. 1. Patients will undergo prostate implantation under general or spinal anesthetic using a Transrectal ultrasound guided transperineal technique. 2. Imaging according to local practice using ultrasound, CT and or MR will be undertaken 3. The CTVp is defined by the prostate capsule and extended to include any extra capsular or seminal vesicle disease. A volumetric expansion of 3mm constrained to the rectum posteriorly is then added. This defines the PTV. 4. Catheter reconstruction and dwell time definition is then undertaken to provide a treatment plan for approval by the treating clinician. 5. Treatment is delivered once an optimized plan has been approved 6. After completion of treatment in the brachytherapy room the implant catheters and urinary catheter are removed; no anesthesia is required for this procedure. 7. The patient will return to the ward and may be discharged home later the same day or the following day Dose prescription A dose of 15Gy in a single treatment exposure defined at the 100% isodose which is the minimum tumour isodose to cover the PTV. PTV recommendations D90: ≥15Gy V100: ≥95% Organs at risk tolerance doses: Rectum D2cc 12Gy Rectum V100 \<15Gy Urethra D10 \<17.5Gy Urethra D30 \<16.5Gy Urethra V150 0cc External Beam Radiation Therapy (EBRT) EBRT would be given to prostate and seminal vesicles only, using either Intensity Modulated Radiotherapy (IMRT) or Volumetric Arc radiotherapy (VMAT) to a dose of 4600cGy in 23 fractions over four and half weeks. The Dose Volume Histogram (DVH) would be according to the local radiotherapy protocol. The gap between BT and EBRT irrespective of their sequence should not exceed more than 3 weeks. Therefore the total Radiotherapy treatment time should be up to seven and half weeks Patients will receive neo-adjuvant and adjuvant anti androgen therapy between 6 months to 3 years according to the risk stratification of the disease as per standard of care All statistical significance testing will be at the 5% significance level. For the IPSS and IIEFS scale scores, the two means at each of the follow-up assessments will be compared using a two-sided permutation t-test using 1000000 random permutations, and the 95% confidence limits for the difference between the means will be calculated using a bootstrap using 9999 re-samplings. There will also be an assessment of trends in the scores through time using a repeated measures analysis of variance on the four follow-up scores with the baseline score as a covariate. For categorical data based on adverse events percentages will be compared using Fisher's Exact Test. In this small study it will be possible to carry out the full combinatorial calculations for Fisher's Exact Test (whereas in a main study 10000 random permutations will be obtained in a Monte Carlo approach.) For differences between percentages the 95% confidence limits will be obtained using Newcombe's Hybrid Score Interval method. For the secondary analysis Prostate-specific antigen relapse-free survival using the Kaplan-Meier method, with a test for difference between the survival curves using the log-rank test with the P-value obtained using permutation test with 10000 permutations. Cox proportional hazards multiple regression will also be used to assess the effects of covariates on survival, with model comparisons carried out using likelihood ratio tests. The analyses will be performed using the computer program R. All randomised participants will be included in the analyses. #Intervention - RADIATION : HDR Brachytherapy - HDR Brachytherapy, a single dose of 15 Gy delivered to prostate - RADIATION : External beam Radiotherapy - External beam Radiotherapy, a dose of 46 Gy in 23 fractions delivered to prostate

#Eligibility Criteria: Inclusion Criteria: * Patient age >18 years * Histologically diagnosed Prostate cancer, stages T1b-T3bN0M0 * Any Gleason score * Any PSA level * Patient able to consent and fill in the questionnaires Exclusion Criteria: * Previous TURP/HoLEP Laser Prostatectomy * Any Metastatic Disease * IPSS>20 * Pubic arch interference * Lithotomy position * If Anaesthesia is not possible * Rectal fistula * Prior pelvic radiotherapy ##Sex : MALE ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03909620", "Brief_Title" : "Utility of LDCT in Lung Cancer Screening in a TB Endemic Region", "Official_title" : "A Study Assessing the Utility of Low-dose Computed Tomography (LDCT) in Lung Cancer Screening in North India", "Conditions" : ["Lung Cancer"], "Interventions" : ["Diagnostic Test: Low-dose computed tomography of chest"], "Location_Countries" : ["India"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SCREENING", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Lung cancer screening with low-dose computed tomography (LDCT) has been recently shown to result in a significant reduction in lung cancer-specific mortality. However, the utility of LDCT screening in developing countries with high incidence of tuberculosis has not been adequately studied. The investigators hypothesize that LDCT screening in tuberculosis endemic regions is likely to yield a large proportion of false-positive results, especially in the initial round of screening, posing a significant burden on the healthcare system. Herein, the investigators assess the utility of LDCT and its cost-effectiveness in India. Detailed Description Screening for lung cancer may reduce lung cancer mortality by diagnosing the disease at an early stage when it is treatable more effectively. There are several methods available for screening of lung cancer. These include sputum cytology, chest radiography, computed tomography (CT) of the chest, and positron emission tomography (PET). However, sputum cytology and chest radiography have been found to be ineffective as screening tests for lung cancer as there is no reduction in lung cancer mortality. The use of CT or PET for lung cancer screening may be associated with unacceptable levels of radiation exposure and enormous cost. Low-dose computed tomography (LDCT) of the chest is a special type of CT, which uses relatively low radiation exposure to create a low-resolution image of the entire thorax. The radiation exposure associated with LDCT is 5-6 times less than that of a conventional CT scan of the thorax. LDCT screening has been to shown to result in a 20% reduction in lung cancer-specific mortality. Several national and international guidelines recommend this strategy for lung cancer screening. Despite these guidelines and recommendations by several organizations, lung cancer screening has not been established in several developing countries, where a controversy arises due to high rates of granulomatous diseases like tuberculosis. Emerging evidence indicates that false positive results with LDCT in developing countries may not be unacceptably high as previously believed. In this study, the investigators intend to assess the utility of lung cancer screening using low-dose computed tomography (LDCT) in India, a country with high prevalence of tuberculosis. #Intervention - DIAGNOSTIC_TEST : Low-dose computed tomography of chest - Eligible subjects will undergo a single round of LDCT screening. The LDCT will be considered as positive if a solid nodule or part-solid nodule of size ≥6 mm or non-solid nodule of size ≥20 mm is identified. Evaluation of positive nodules will be performed as per existing standard recommendations - Other Names : - LDCT, Low-dose CT

#Eligibility Criteria: Inclusion Criteria: * Individuals aged 55 <= age <= 74 years with at least 30 pack-year history of smoking (or smoking index >=600) who are current smokers or quit within the last 15 years OR * Individuals aged 50 <= age <= 74 years with at least 20 pack-year history of smoking (or smoking index >=400) who are current or former smokers with COPD or family history of lung cancer in any first-degree relative Exclusion Criteria: * Symptomatic structural lung disease other than COPD (e.g. bronchiectasis, chronic pulmonary aspergillosis, pulmonary fibrosis) * Severe comorbid condition which is likely to limit the survival of the patient in the opinion of the investigator (e.g. advanced lung disease, cardiovascular disease, chronic kidney disease, chronic liver disease) * Presence of symptoms which lead to a suspicion of lung cancer (e.g. hemoptysis or unexplained weight loss [>5 kg] within the last 6 months) * Conditions which may interfere interpretation of CT (e.g. metallic implants on chest wall, cardiac pacemakers) * Treatment for any other cancer in the last 5 years * Pulmonary infection (for which treatment with antimicrobials is indicated) which is active at present or was recent (within the last 3 months) * Patients who have underwent CT chest within the last 18 months * Negative consent ##Sex : ALL ##Ages : - Minimum Age : 50 Years - Maximum Age : 74 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: Yes

{ "NCT_ID" : "NCT03672422", "Brief_Title" : "Pediatric Longitudinal Cohort Study of Chronic Pancreatitis", "Official_title" : "Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC) CPDPC16-03 Pediatric Longitudinal Cohort Study of Chronic Pancreatitis", "Conditions" : ["Pancreatitis, Chronic", "Pancreatitis, Acute"], "Interventions" : ["Diagnostic Test: Urine sample", "Behavioral: Patient questionnaires", "Diagnostic Test: Saliva sample", "Diagnostic Test: Blood sample"], "Location_Countries" : ["United States", "Canada", "Israel", "Australia"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary The investigators will enroll a total of 628 patients under 18 years of age with ARP or CP. Included in the total are the 357patients in the INSPPIRE 1 database who are planned to be reenrolled under this protocol over the next 4 years. Patient questionnaires and physician surveys will be applied at the time of enrollment and annually thereafter as long as possible. At the first study visit after turning 18 years of age, the patient will sign the informed consent to continue in the study. Specifically, the investigators will define the demographics of the pediatric ARP and CP cohort, describe risk factors, presence of family history of acute and chronic pancreatitis, diabetes and pancreatic cancer and assess disease burden and sequelae. Detailed Description Disease Burden Pain. The pattern of the pain (constant versus episodic), its frequency, duration, visits to the emergency room or hospitalizations for pain, impact of pain on quality of life will be recorded in questionnaires. The intensity of the pain will be measured at enrollment, during an attack and annually using FACES Pain Scale-Revised, a self-report questionnaire validated for children \>4 y/o. The names, dosing and frequency of medications taken for pain will also be queried. Health-Related Quality of Life (HRQOL). An age-specific instrument validated for United States children will be used to measure HRQOL at enrollment and annually thereafter. Parents of children 5-18 years old will complete Child Health Questionnaire Parent Form 50 questions (CHQ PF-50). Children \>10 years old will answer Child Health Questionnaire Child Form 87 questions (CHQ-87). Adults \>18 years old will not complete a health-related questionnaire. These questionnaires capture physical functioning, social, emotional, physical and behavioral limitations, bodily pain, general behavior, mental health, self-esteem, general health perceptions, change in health and parental emotional impact. Depression and anxiety. Depression and anxiety are strong predictors of chronic pain and pain-related disability in children, but it is not known whether this applies to children with ARP or CP. The investigators will assess for depression and anxiety in the INSPPIRE cohort at the time of enrollment and annually thereafter. The investigators will utilize the Child Behavioral Checklist (CBCL), one of the most widely-used standardized measures in child psychology for evaluating maladaptive behavioral and emotional problems in preschool subjects aged 1½ to 5 years and in school-age subjects between the ages of 6 and 18. For preschool-age children, the CBCL/1½-5 (completed by parents or surrogates) will be used. For school-age children 6-18 y/o, the investigators will utilize CBCL/6-18 y/o (completed by parents or surrogates). Children who are 11-18 y/o will answer a self-report questionnaire (Youth-Self Report Form or YSR/11-18). CBCL assesses internalizing (i.e., anxious, depressive, and over controlled) and externalizing (i.e., aggressive, hyperactive, noncompliant, and undercontrolled) behaviors. Adults \>18 years old will not complete a behavioral checklist. Patients/parents will spend approximately 2 hours answering questionnaires; their time will be compensated at $50 per visit. Patients will be enrolled during clinic visit as outpatient or as an inpatient. Alternatively, questionnaires can be applied over the phone or completed at home and returned via mail if the patient is unable to travel. Self-addressed stamped envelopes will be given to the patient/parent as needed for returning the questionnaires. Disease Sequelae The presence of exocrine pancreatic insufficiency and glucose intolerance/diabetes will be monitored at the time of enrollment and annually thereafter. Monitoring will include specifically: 1. Exocrine pancreatic insufficiency: defined as the presence of abnormal fecal elastase (\< 100 ug/ g stool on 2 separate samples ≥ 1 month apart) or abnormal serum trypsin or serum trypsinogen. 2. Diabetes or prediabetes: Monitoring for diabetes in our cohort will include once yearly assessments with fasting glucose (diabetes range if ≥ 126 mg/dL), HbA1c (abnormal if \>6; diabetic if \>6.5%) and oral glucose tolerance test (OGTT). For OGTT, 1.75 grams/kg of standard glucose beverage (glucola, maximum 75 grams) will be consumed within 10 minutes at time 0. Glucose will be drawn prior to the beverage and at time 120 minutes. From this test, glycemic status will be defined as: (1) normal glucose tolerance (NGT, fasting glucose \<100 mg/dL, 2 hour \<140 mg/dL); (2) pre-diabetic based on impaired fasting glucose (IFG, fasting glucose 100-125 mg/dL) and/or impaired glucose tolerance (IGT, 2 hour glucose 140-199 mg/dL); or (3) diabetic (DM, fasting glucose \>126 mg/dL or 2 hour glucose \>200 mg/dL). 3. Nutritional status including micronutrient deficiency: To determine the nutritional sequelae of ARP or CP in children, the investigators will assess for malnutrition/obesity (weight, height, BMI, z scores; body fat mass and lean mass as measured by DXA scan), fat soluble vitamin deficiencies (serum vitamin levels for A, D, and E and bone density (DXA scan) in children with ARP or CP at the time of enrollment and annually thereafter. The investigators will identify subjects within our cohort that presented with acute recurrent pancreatitis episodes, normal exocrine and endocrine pancreas function and normal pancreas imaging without any signs of chronicity (ARP cohort). The investigators will identify the development of CP on an annual basis as long as possible, as well as development of sequelae and disease burden as listed above. Prospective Registry The investigators will develop a database of children with ARP and CP. This will provide a cohort of well-phenotyped subjects for future studies targeting pathogenesis and novel therapies. The investigators will establish a process by which investigators outside of the consortium may have access to the data and biospecimens. At enrollment, via the informed consent, subjects will choose whether or not to allow use of their biological samples for this study, future research, genetic analysis, genetic analysis for future research, and any type of future research. They will also choose whether or not we may keep their name and personal information in a registry to allow us to contact them for other future research. BIOSPECIMEN COLLECTION Sample collection for deoxyribonucleic acid (DNA): The subject will be able to give either blood or saliva. Six ml of blood will be collected from subjects in an ethylenediaminetetraacetic acid tube or 2 ml saliva samples in Oragene DNA collection kits then labeled with the barcoded specimen labels provided by the Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC) Coordinating Center. The specimen labels provided by CPDPC include a specimen identification (ID) number and barcode. Subject identifiers (for example names or initials) are not included on the labels. Before shipping the specimens to the central repository the specimen ID number from the label will be connected to the patient information in the CPDPC's secure IIMS Specimen Manager system. After the specimen ID number is linked to the subject in the CPDPC system the samples will be submitted to the central repository for the study via overnight courier. The central repository for DNA will be at the University of Iowa. The central repository at Iowa will not have access to the link that connects to the patient's personal identifiers in the Integrated Information Management System (IIMS). The central repository will log receipt of the specimens into the CPDPC IIMS Specimen Manager system using the specimen ID from the labeled vials. The central repository will process the specimens into aliquots for the extraction of genomic DNA following the CPDPC specimen processing described in the appendices. The aliquots will be labeled with CPDPC supplied labels and stored in a freezer at -80 degree Centigrade. The CPDPC aliquots labels contain barcodes and specimen ID numbers that do not link the aliquots to each other. The only link to the subject information resides in the secured database at the CPDPC coordinating and data management center. The central repository laboratory staff and the study researchers do not have access to this link. At the end of the study the specimens stored in the central repository at Iowa will be transferred to a central repository at National Institute of Diabetes and Digestive and Kidney Diseases. Urine collection for bio-markers: To be completed only at sites identified by the lead site to collect urine samples. Not all sites will be collecting urine. See Appendix 14.27 for collection and processing instructions. The subject will be instructed to collect a minimum of 50 mL clean-catch urine sample. A dipstick urine analysis will be performed immediately after urine collection. Urine samples will then be kept on wet ice or refrigerated until processed. Samples will be processed within 4 hours of collection. Samples will be labeled with the barcoded specimen labels provided by the CPDPC Coordinating Center. The specimen labels provided by CPDPC include a specimen ID number and barcode. Subject identifiers (for example names or initials) are not included on the labels. Before shipping the specimens to the central repository the specimen ID number from the label will be connected to the subject information in the CPDPC's secure IIMS Specimen Manager system. After processing, samples will be frozen at -80ºC. The urine processing log sheet will be completed. Samples will be stored and batch shipped to the Central repository at University of Iowa annually. The central repository will log receipt of the specimens into the CPDPC IIMs Specimen Manager system using the specimen ID from the labeled vials. The central repository at University of Iowa will not have access to the link that connects the subject's personal identifiers in the IIMS system. The central repository will log receipt of the specimens into the CPDPC IIMS Specimen Manager system using the specimen ID from the labeled vials. The CPDPC aliquots labels contain barcodes and specimen ID numbers that do not link the aliquots to each other. The only link to the subject information resides in the secured database at the CPDPC coordinating and data management center. The central repository laboratory staff and the study researchers do not have access to this link. At the end of the study the specimens stored in the central repository at Iowa will be transferred to a central repository at NIDDK. #Intervention - DIAGNOSTIC_TEST : Blood sample - Six ml of blood will be collected from patients in an EDTA tube. 2 ml saliva samples in Oragene DNA collection kits - BEHAVIORAL : Patient questionnaires - Questionnaires will be completed at the baseline and annual follow-up visits to collect data that will define the demographics of the pediatric ARP and CP cohort, describe risk factors, presence of family history of acute and chronic pancreatitis, diabetes and pancreatic cancer and assess disease burden and sequelae. - DIAGNOSTIC_TEST : Saliva sample - 2 ml saliva samples in Oragene DNA collection kits collected if no blood sample being collected. - DIAGNOSTIC_TEST : Urine sample - 50 ml of urine in collection container.

#Eligibility Criteria: Inclusion Criteria: * All patients/parents must sign an informed consent and/or assent indicating that they are aware of the investigational nature of this study. 2 Patients/parents must have signed an authorization for the release of their or their child's protected health information. 3 All children providing samples should fit the ARP or CP inclusion criteria defined below. 4 All children must be under 18 years at the time of enrollment. Acute pancreatitis (AP): AP is defined as requiring 2 of the following: * Abdominal pain compatible with AP, * Serum amylase and/or lipase values >=3 times upper limits of normal, * Imaging findings of AP, such as gland enlargement, acute inflammatory changes, and fluid collections. ARP is defined as: At least 2 episodes of acute pancreatitis with complete resolution of pain and a >1 month pain-free interval between episodes. Chronic Pancreatitis: Children with at least: * One irreversible structural change* in the pancreas with or without abdominal pain +/- exocrine pancreatic insufficiency +/- diabetes. *irreversible structural changes: * Ductal calculi, dilated side branches, parenchymal calcifications found in any imaging (abdominal ultrasound (abd US), magnetic resonance imaging/magnetic resonance cholangiopancreatography (MRI/MRCP), computerized tomography (CT), endoscopic retrograde cholangiopancreatography (ERCP), endoscopic US (EUS). * Ductal obstruction or stricture/dilatation/irregularities that are persistent (for >2 months) on any imaging. * Parenchymal atrophy, irregular contour, accentuated lobular architecture, cavities alone are not diagnostic findings for CP. * Surgical or pancreatic biopsy specimen demonstrating histopathologic features compatible with CP (acinar atrophy, fibrosis, protein plugs, infiltration with lymphocytes, plasma cells, macrophages). Exclusion Criteria: * Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate study interventions. ##Sex : ALL ##Ages : - Minimum Age : 0 Years - Maximum Age : 17 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : CHILD ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02271711", "Brief_Title" : "Expanded Natural Killer Cell Infusion in Treating Younger Patients With Recurrent/Refractory Brain Tumors", "Official_title" : "Phase I Study of Intraventricular Infusions of Autologous Ex Vivo-Expanded NK Cells in Children With Recurrent/Refractory Malignant Posterior Fossa Tumors of the Central Nervous System. NOAH's (New Opportunity, Advancing Hope) Protocol", "Conditions" : ["Recurrent Childhood Medulloblastoma", "Recurrent Ependymoma", "Recurrent Medulloblastoma"], "Interventions" : ["Biological: Natural Killer Cell Therapy", "Other: Laboratory Biomarker Analysis"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This phase I trial studies the side effects and best dose of expanded natural killer cells in treating younger patients with brain tumors that have come back or do not respond to treatment. Infusing a particular type of a patient's own white blood cells called natural killer cells that have been through a procedure to expand (increase) their numbers may work in treating patients with recurrent/refractory brain tumors. Detailed Description PRIMARY OBJECTIVES: I. To establish the safety, feasibility, efficacy, and maximum tolerated dose (MTD) of administering autologous natural killer (NK) cells that have been propagated ex vivo with artificial antigen-presenting cells (aAPC) and administered directly into the ventricle in recurrent /refractory malignant posterior fossa tumors. SECONDARY OBJECTIVES: I. To assess the antitumor activity based on imaging and cytology of autologous NK cell locoregional administration directly into the lateral or fourth ventricle. II. To determine the persistence of adoptively-transferred expanded NK cells (as performed with excess NK cells, via optional correlative studies). III. Determine the immunophenotype and function of expanded NK cells. IV. Determine the overall response of medulloblastoma to NK-cell therapy. V. Correlate NK cell persistence, phenotype, and function with overall response. OUTLINE: This is a dose-escalation study. Patients receive autologous expanded NK cells intravenously (IV) into the ventricle over 3 minutes once weekly on weeks 1-3. Treatment repeats every 4 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing disease progression may continue treatment at the discretion of the treating physician if pseudo-progression or benefit of slowed progression is suspected. After completion of study treatment, patients are followed up within 30 days. #Intervention - OTHER : Laboratory Biomarker Analysis - Correlative studies - BIOLOGICAL : Natural Killer Cell Therapy - Given autologous ex-vivo expanded NK cells IV

#Eligibility Criteria: Inclusion Criteria: * Diagnosis: patients with recurrent/refractory medulloblastoma (MB), atypical teratoid (AT)/rhabdoid tumors (RT) or ependymoma involving the brain and/or spine at original diagnosis or relapse; they must have histological verification at diagnosis and/or relapse; patient must have presented with these tumors in the posterior fossa (PF) or relapsed in the PF * Patient must have either measurable or evaluable tumor * Presence of or determined by neurosurgery to be a candidate for an implanted catheter in the ventricles to receive NK cell infusion * Life expectancy of at least 12 weeks in opinion of principal investigator (PI) and/or designee * Lansky score of 50 or greater if =<16 years or a Karnofsky score of 50 or greater if > 16 years (NOTE: patients who are unable to walk because of paralysis, but who are in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score) * Neurologic deficits must have been relatively stable for a minimum of 1 week prior to study enrollment * Patients must have recovered from the acute toxic effects of all prior anticancer chemotherapy * Patient must be 4 weeks off any palliative radiation or craniospinal radiation * Absolute neutrophil count (ANC) of >= 1000/uL * Platelet count of >= 30,000 * Hemoglobin of >= 9.0 g/dl * Patients with a seizure disorder may be enrolled if well-controlled and on non-enzyme inducing anticonvulsants * Patient or patient's legal representative, parent(s), or guardian able to provide written informed consent Exclusion Criteria: * Enrolled in another treatment protocol * Evidence of untreated infection * Extra-cranial metastasis * Chronic corticosteroid dependence (except replacement therapy) * Extensive disease, disease location, and/or co-morbid condition that the PI or designee considers unsafe for surgical intervention of NK cell infusion * Pregnant or lactating women ##Sex : ALL ##Ages : - Maximum Age : 21 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, CHILD ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT03604211", "Brief_Title" : "SBRT for Oligometastatic Lymph Node Recurrence in Prostate Cancer: a Single Institution Experience", "Official_title" : "Predictive Factors for the Benefit of Stereotactic Body Radiotherapy for Oligometastatic Lymph Node Recurrence in Prostate Cancer: a Single Institution Experience", "Conditions" : ["Prostate Cancer Recurrent", "Prostate Cancer", "Lymph Node Metastases"], "Location_Countries" : ["Switzerland"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary Single-institution retrospective analysis for predictive factors of prostate cancer patients presenting with isolated or limited lymph node (LN) recurrence (1-3 lesions) on F-Ccholine PET-CT (CholPET) treated with SBRT between January 2010 and July 2015. Detailed Description Single-institution retrospective analysis of consecutive prostate cancer patients after definitive primary treatment, without local recurrence, presenting with isolated or limited lymph node (LN) recurrence (1-3 lesions) on F-Ccholine PET-CT (CholPET) treated with SBRT between January 2010 and July 2015. Endpoints of interest are biochemical response rate (defined as a reduction by at least 10% of the initial PSA value), time to biochemical recurrence (TBR) (defined as the time interval from SBRT until second PSA rise), and time interval between SBRT and ADT start. Univariate analysis is used to identify prognostic factors. #Intervention - RADIATION : Cyberknife Radiation Therapy - Stereotactic Radiotherapy of lymphnode recurrence after prostatectomy +/- salvage radiotherapy

#Eligibility Criteria: Inclusion Criteria: * histologically proven diagnosis of prostate cancer * Radical prostatectomy (± salvage radiotherapy) * PSA relapse (defined by two consecutive rising PSA values >0.2 ug/l) * one to three lymphnodes positive on Choline-PET * no recurrence in prostatic bed on Choline-PET * WHO performance status of 0 <= age <= 1 * no previous chemotherapy or ADT for prostate cancer. Exclusion Criteria: * primary treatment for prostate cancer by RT or brachytherapy * bone (M1b) metastases * visceral (M1c) metastases * any symptomatic nodal lesion ##Sex : MALE ##Ages : - Minimum Age : 18 Years - Maximum Age : 85 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00266799", "Brief_Title" : "The Efficacy and Safety of Pegylated Liposomal Doxorubicin Compared With Capecitabine as First Line Chemotherapy for Metastatic Breast Cancer (P04445/MK-2746-071)", "Official_title" : "A Randomized, Open-Label Trial Comparing Treatment With Either Pegylated Liposomal Doxorubicin or Capecitabine as First Line Chemotherapy for Metastatic Breast Cancer (PELICAN Trial)", "Conditions" : ["Breast Cancer"], "Interventions" : ["Drug: Pegylated liposomal doxorubicin (SCH 200746)", "Drug: Capecitabine"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE3"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This is an open-label, multinational, randomized, multicenter trial designed to compare pegylated liposomal doxorubicin with capecitabine as first line chemotherapy of metastatic breast cancer. The primary objective of the study is to compare the time to disease progression, although overall response rates, overall survival, quality of life, time to treatment failure, and safety and tolerability will also be assessed. #Intervention - DRUG : Pegylated liposomal doxorubicin (SCH 200746) - pegylated liposomal doxorubicin (50 mg/m\^2 q 28 days) was administered intravenously until disease progression or unacceptable toxicity - DRUG : Capecitabine - capecitabine (1250 mg/m\^2 BID x 14 days q 21 days) in tablets of 150 mg and 500 mg was administered orally, until disease progression or unacceptable toxicity

#Eligibility Criteria: Inclusion Criteria: * Patients must be female. * Patients must have metastatic disease of a cytological or histological confirmed breast cancer. * Patients must be >= 18 years. * Patients should have evaluable disease (at least uni-dimensionally measurable lesion according to the RECIST criteria in at least one site that has not been irradiated), however, patients who only have non-measurable/evaluable disease are not excluded. Also patients with only bone metastasis are not excluded. * Patients must have an Eastern Cooperative Oncology Group (ECOG) 0 <= age <= 2. * Patients must have a sufficient life expectancy to be treated with chemotherapy. * Patients must be willing and able to complete study questionnaires. * Patients must have adequate renal function as evidenced by serum creatinine <=1.5 mg/dL, or a creatinine clearance of >=45 mL/min (if serum creatinine is > 1.5 mg/dL but <= 1.8 mg/dL). * Patients must have adequate bone marrow function as evidenced by leukocyte count greater than 3.5 g/L, hemoglobin >=9.0 g/dL, and platelet count >=100x10^9/L. * Patients must have adequate liver function as evidenced by bilirubin of <=1.5 times the upper limits of normal (ULN) and alkaline phosphatase <=3 times, ULN unless related to liver metastasis. * Patients must have Sodium and Potassium values within normal limits. * Patients whose clinical condition (co-morbidity) allows a treatment with monotherapy or who expressed their wish to be treated with monotherapy. * Patients must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. Exclusion Criteria: * History of receiving prior chemotherapy in the metastatic setting (Note: patients may have had hormonal therapy or chemotherapy in the adjuvant setting; patients may have received hormonal therapy in metastatic setting, patients may have received local radiotherapy). * Patients with positive estrogen- / progesterone-receptor status, where an endocrine therapy is indicated. However, patients progressing under hormonal therapy are not excluded. * Patients with known hypersensitivity to doxorubicinhydrochlorid or to any of the excipients OR known hypersensitivity to capecitabine or fluorouracil or to any of the excipients. * Patients with known DPD (dihydro pyrimidine dehydrogenase) deficiency. * Patients who are receiving a concomitant treatment with sorivudine or its chemically related analogues, such as brivudine. * Patients who are taking concomitant medications (except bisphosphonates) for metastatic disease, including hormonal therapy, radiation therapy, trastuzumab, or biologicals are also not permitted. * Patients with Human epidermal growth factor receptor 2 (Her-2/neu) overexpressing tumors with the most recent evaluation as the relevant result * immunologically Her2neu 3+ positive * Her2neu-2+ positive and ´Fluorescent in-situ hybridization (FISH)´ positive * History of treatment with capecitabine * History of treatment with anthracyclines in the adjuvant setting exceeding cumulative doses of anthracyclines by more than 360 mg/m^2 doxorubicin (or equivalents, i.e. 600mg/m^2 epirubicine). * Patients with anthracycline resistant disease are not permitted. Anthracycline resistance is defined as development of locally recurrent or metastatic disease while on adjuvant anthracycline therapy, or relapse less than 12 months after completion of anthracycline therapy. * Strong remission pressure that requires polychemotherapy with the exception of patients who are not suitable for a treatment with polychemotherapy or not accepting polychemotherapy. * Evidence of primary or metastatic malignancy involving the central nervous system unless previously treated and asymptomatic for 3 months or greater. * Patients with reduced liver functions (evidenced by bilirubin of above 1.5 times the upper limits of normal (ULN); alkaline phosphatase above 3 times ULN (except related to liver metastasis, in which case <=5 x ULN). * Dyspnea on exertion. * History of cardiac disease, with New York Heart Association Class II or greater, or clinical evidence of congestive heart failure or myocardial infarct within less than six months or an left ventricular ejection fraction (LVEF) below 50%. * Woman with childbearing potential with insufficient contraception [e.g. intra-uterine device (IUD) are regarded as sufficient] during the study period and the six months following the last study drug application. All methods based on hormonal contraception are not permitted. * Existing pregnancy or lactation (note on pregnancy test). A negative pregnancy test for women of childbearing potential has to be in place prior randomization (Note: A pregnancy test has to be done for patients who are not postmenopausal. Postmenopausal is defined as those not having a menstrual period for 12 months in a row). * Existing doubts on ability and willingness of the subject for cooperation. * Participation of the subject at a clinical study within the last 30 days. * Participation of the subject in the same clinical study at an earlier date. * Concomitant participation in another study than the one described here. * Abuse of drugs, alcohol, or pharmaceuticals. * Any condition, whether medical or non-medical, that may interfere, in the opinion of the investigator, with aim of this study. ##Sex : FEMALE ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01683877", "Brief_Title" : "Efficacy Study of FloSeal in Hemostasis After Laparoscopic Ovarian Cystectomy", "Official_title" : "PROSPECTIVE RANDOMIZED CONPARISON OF ELECTRONIC DIATHERMY VERSUS FLOSEAL IN HEMOSTASIS AFTER LAPAROSCOPIC OVARIAN CYSTECTOMY", "Conditions" : ["Benign Ovarian Tumor"], "Interventions" : ["Procedure: Electrocautery", "Procedure: FloSeal application"], "Location_Countries" : ["Korea, Republic of"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "SINGLE" } }

#Study Description Brief Summary To compare the efficacy in postoperative hemostasis and in sparing postoperative ovarian function between FloSeal and Electrocauterization in laparoscopic ovarian cystectomy #Intervention - PROCEDURE : FloSeal application - After laparoscopic ovarian cystectomy, hemostasis will be performed using FloSeal (1 vial of FloSeal 5mL per unilateral ovarian cystectomy) - PROCEDURE : Electrocautery - After laparoscopic ovarian cystectomy, hemostasis will be performed using electrocautery

#Eligibility Criteria: Inclusion Criteria: * Premenopausal women * Patients who is planned to undergo laparoscopic ovarian cystectomy * American Society of Anesthesiologists Physical Status classification (ASA PS) 1 <= age <= 2 * Patients with adequate bone marrow, renal and hepatic function: WBC > 3,000 cells/mcl Platelets >100,000/mcl Creatinine <2.0 mg/dL Bilirubin <1.5 x normal and SGOT or SGPT <3 x normal * Patient must be suitable candidates for surgery * Patients who have signed an approved Informed Consent Exclusion Criteria: * Patients with a history of pelvic or abdominal radiotherapy; * Patients who are pregnant or nursing * Patients who is receiving or requires hormone replacement therapy after surgery * Patients who is undergoing hysterectomy at this time * Patients who is undergoing unilateral or bilateral oophorectomy * Previous history of ovarian cystectomy or oophorectomy * Patients with contraindications to surgery * Unfit for Surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator) * Patient compliance and geographic proximity that do not allow adequate follow-up. * Hormone therapy within 3 months before surgery ##Sex : FEMALE ##Ages : - Minimum Age : 20 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT00975975", "Brief_Title" : "Basiliximab #2: In-Vivo Activated T-Cell Depletion to Prevent Graft-Versus_Host Disease (GVHD) After Nonmyeloablative Allotransplantation for the Treatment of Blood Cancer", "Official_title" : "Basiliximab #2: In-Vivo Activated T-Cell Depletion to Prevent GVHD After Nonmyeloablative Allotransplantation for the Treatment of Blood Cancer", "Conditions" : ["Acute Myelogenous Leukemia", "Acute Lymphocytic Leukemia", "Chronic Myelogenous Leukemia", "Chronic Lymphocytic Leukemia", "Myelodysplasia", "Non-Hodgkin's Lymphoma", "Hodgkin's Disease", "Multiple Myeloma", "Myelofibrosis", "Anemia, Aplastic", "Hemoglobinuria, Paroxysmal"], "Interventions" : ["Drug: Basiliximab"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE2"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to compare the effects (good and bad) of the medication basiliximab in combination with cyclosporine (investigational therapy) for the prevention of a complication of bone marrow transplantation known as graft-versus-host disease (GVHD). GVHD is a complication in which the cells of the transplanted bone marrow react against organs and tissues. Detailed Description This study is for patients with a blood condition or myelodysplasia (bone marrow disease) which has either not responded to treatment or is not treatable by conventional/routine medical treatments. Bone marrow transplantation is a medical treatment that involves giving high doses of chemotherapy followed by the transplantation of the blood-forming and immune cells from a relative or from a 'matched' unrelated person through the National Marrow Donor Program, in an attempt to cure disease in the recipient (the person receiving the donated cells). Nonmyeloablative (bone-marrow preservation) bone marrow transplantation is a relatively new technique in which lower than usual doses of chemotherapy are given before transplantation, in hopes of reducing adverse side effects of the chemotherapy in transplant patients. Nonmyeloablative bone marrow transplantation has several advantages which doctors have determined are beneficial for this condition. This research is being done because the complication of graft-versus-host disease can be bad for a person and there is no completely safe and effective way to prevent this complication. We know that cyclosporine helps but would like to know if the addition of basiliximab, given with cyclosporine, will decrease the incidence and/or severity of graft-versus-host disease after a transplant known as nonmyeloablative or 'mini' transplant. #Intervention - DRUG : Basiliximab - Basiliximab given 1 time on Day +7 or Day +9. - Other Names : - Simulect

#Eligibility Criteria: Inclusion Criteria: * Acute myelogenous leukemia: * Second or subsequent remission; patient over 18 yrs of age. * Relapsed after autologous HC transplant, > 18 years. * First remission, Philadelphia chromosome + over age 18. * Secondary AML, in first or subsequent remissions. * Acute lymphocytic leukemia: * Philadelphia chromosome + over the age of 50, first or subsequent remission. * Relapse following Autologous HC transplantation, ages over 50. * Second or subsequent remission over the age of 50 * Chronic myelogenous leukemia: * First or second chronic phase over the age of 18. * Accelerated phase over the age of 18. * Must have failed or been intolerant to a standard tyrosine kinase inhibitor. * Chronic lymphocytic leukemia: * Failed nucleoside-based therapy, ages >18. * Myelodysplasia: * All-risk categories, age greater than 18. * Non-Hodgkin's Lymphoma, less than 76 years * Relapsed diffuse aggressive NHL (intermediate and high grade) that fails to achieve CR or PR to conventional salvage chemotherapy. * Aggressive NHL includes diffuse large B cell lymphoma, diffuse mixed small and large cell lymphoma, follicular lymphoma for grade 3 (follicular large cell lymphoma), T or B cell lymphoblastic lymphoma, diffuse small noncleaved (Burkett's or Burkett-like ) lymphoma, mantle cell lymphoma, peripheral T cell lymphoma, anaplastic large cell lymphoma, and other diffuse aggressive lymphomas that are not otherwise classifiable * Aggressive NHL that has relapsed following autologous HCT. Patients that respond to additional treatment for post-transplant relapse are eligible. * Aggressive NHL that does not achieve CR or PR with primary chemotherapy (i.e., primary induction failure). * Low-grade lymphoma refractory to standard therapy, including the following: 1. small cell lymphocytic lymphoma, 2. follicular lymphoma of grades 1 and 2 (follicular small cleaved and follicular mixed small and large cell lymphoma) 3. marginal cell lymphoma, splenic lymphoma), 4. lymphoplasmacytic lymphoma and 5. other lymphomas not otherwise classifiable. * Patients with low-grade lymphoma must have experienced progressive disease after receiving three or more of the following regimens: * alkylator-based therapy (cyclophosphamide/ vincristine/ prednisone) chlorambucil, monoclonal antibody based therapy (e.g., rituximab, Campath-1H, radiolabelled CD20+ antibodies); * nucleoside analog-based therapy (e.g., fludarabine, cladribine).) * Patients with marginal zone lymphoma or gastric MALT type associated with Helicobacter pylori infection must have progressed after receiving appropriate antibiotic therapy as well as three or more regimens as described above * Mantle cell, ages 18 <= age <= 75. * Hodgkin's Disease, ages 18 <= age <= 75. * Relapsed or refractory disease after autologous transplant. * Multiple Myeloma, ages 18 <= age <= 75 * Recurrent disease after two medical therapies * Relapse following autologous transplant * Myelofibrosis, age greater than 18 years * Severe aplastic anemia (refractory to immunosuppressive therapy); age greater than 18 years * Patients with aplastic anemia must have marrow cellularity <= 10% plus 2 of the following: 1. Absolute granulocyte count <500/mm3 2. Corrected reticulocyte count <1% 3. Untransfused platelet count <20,000/mm3 on at least 2 occasions 4. Hemoglobin <9 g/dL (adults) or < 8 g/dL (children) on at least 2 occasions * Paroxysmal nocturnal hemoglobinuria; age greater than 18 years. * Renal function: creatinine greater than 2.5 * Donor Requirement: * Must have a fully HLA-matched (10 of 10 Antigen matched) related or unrelated donor, eighteen years of age or older, who is capable of undergoing GCSF mobilization and apheresis Exclusion Criteria: * Active CNS disease (the presence of leukemic blasts in the CSF) * Pregnancy or breast-feeding. * Inability to give informed consent. * AST, ALT, total bilirubin >3x upper limit of normal. * Creatinine > 2 or creatinine clearance < 50mL/hr. If patient has a creatinine of > 2 or creatinine clearance < 50mL/hr and it is due to the disease process then the patient will not be excluded based on this. * Fractional shortening by echocardiogram not within normal limits per institution or LVEF of < 40 %. * Pulmonary function: DLCO not within institutional normal limits or DLCO less than 45% of normal predicted, corrected for anemia * Prior allogeneic transplant. ##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

{ "NCT_ID" : "NCT02283190", "Brief_Title" : "1336GCC: Study of Erwinaze for Treatment of Acute Myeloid Leukemia (AML)", "Official_title" : "1336GCC: Open-Label, Single-Arm PK Study of IV Erwinaze (Asparaginase Erwinia Chrysanthemi) to Find the Dose With Acceptable Therapeutic and Safety Profile in Adults With Acute Myeloid Leukemia With or Without Isocitrate Dehydrogenase Mutations", "Conditions" : ["Acute Myeloid Leukemia"], "Interventions" : ["Drug: Erwinase"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "OTHER", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Erwinaze will be administered intravenously at a dose of 25,000 IU/m2 (dose cohort 0) for 6 doses MWF over a period of 2 weeks to 9 patients (as described below and in the following schema). Blood counts, chemistries including bilirubin, amylase and lipase, and coagulation studies including fibrinogen will be measured and reviewed before each asparaginase dose. Fibrinogen (\<100 mg/dL) can be replaced with cryoprecipitate before each dose at the discretion of treating physician. Treatment will be stopped for elevation of amylase, lipase or direct bilirubin above normal range. Detailed Description For safety: Erwinaze has been already used in clinical practice for treatment of patients with acute leukemia with known side effect profile. For this reason, in this protocol, we use the '3+3+3' design for evaluation of safety based on pre-determined dose-limiting toxicities (DLT). In the '3+3+3' design, the dose escalation rules proceed by adjusting the dose in cohorts of 3 to 9 patients per three dose levels:20,000 IU/m2 (dose cohort -1), 25,000 IU/m2 (dose cohort 0), 30,000 IU/m2 (dose cohort +1). The goal is to determine the Recommended Phase 2 Dose (RP2D) For anti-leukemic activity: To evaluate the activity of Erwinaze to reduce the serum glutamine to the desired level, the dose will be adjusted according to a pre-defined algorithm based on 48-hour trough serum glutamine level (biochemical response) prior to dose 6 of each patient. If the safety profile is acceptable, we will enroll up to a total of 15 patients at that dose level to better study and analyze the glutamine-reducing effect of Erwinaze at the defined dose. In summary, if 9 patients are treated at a certain dose and at least 7 out of 9 individuals respond to treatment (per serum glutamine levels) and \< 3 develop DLT, this dose level will be declared the Recommended Phase 2 Dose (RP2D). Six additional patients (total of 15 to 18 patients) will be enrolled at the RP2D level to better assess toxicity and to document responses. There will be no intra-patient dose escalation or reduction. #Intervention - DRUG : Erwinase - Six doses of Erwinase, given Monday-Wednesday-Friday for 2 weeks. Dosage levels to be used are: 20,000 IU/ m2 /day, 25,000 IU/ m2 /day, 30,000 IU/ m2 /day. - Other Names : - Asparaginase, Crisantaspase

#Eligibility Criteria: Inclusion Criteria: * Histologically or cytologically confirmed AML * 18 years and older * AML has relapsed after, or is refractory to, first-line therapy, with or without subsequent additional therapy * Have received or are ineligible for immediate established curative regimens * ASCT patients are eligible provided that they are >= 4 weeks from stem cell infusion * alloSCT patients are eligible if they are >= 60 days post stem cell infusion, have no evidence of graft versus host disease (GVHD) > Grade 1, and are >= 2 weeks off all immunosuppressive therapy * Previous cytotoxic chemotherapy completed at least 3 weeks and radiotherapy at least 2 weeks prior to day 1 of study treatment * Biologic agents stopped at least 1 week prior to day 1 of study treatment * DNA methyltransferase inhibitors stopped at least 3 weeks prior to day 1 of study treatment * ECOG performance status <=2 * Patients must have normal organ function * Female patients of childbearing potential must have a negative pregnancy test. * Ability to understand and willingness to sign a written informed consent document. Exclusion Criteria: * Patients receiving any other investigational agents, or concurrent chemotherapy, radiation therapy, or immunotherapy * Patients with acute promyelocytic leukemia * Patients with active central nervous system leukemia * Prior treatment with Erwinaze * Hyperleukocytosis with > 50,000 blasts/μL * History of a major thrombotic event * History of pancreatitis * Active, uncontrolled infection * Uncontrolled intercurrent illness * Pregnant women * Uncontrolled active seizure disorder or a history of seizure ##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

{ "NCT_ID" : "NCT03892044", "Brief_Title" : "Duvelisib and Nivolumab in Treating Patients With Richter Syndrome or Transformed Follicular Lymphoma", "Official_title" : "A Phase I Study of Duvelisib in Combination With Nivolumab for Patients With Richter's Syndrome and Transformed Follicular Lymphoma", "Conditions" : ["Chronic Lymphocytic Leukemia", "Recurrent Diffuse Large B-Cell Lymphoma", "Refractory Diffuse Large B-Cell Lymphoma", "Richter Syndrome", "Small Lymphocytic Lymphoma", "Transformed Chronic Lymphocytic Leukemia to Diffuse Large B-Cell Lymphoma", "Transformed Follicular Lymphoma to Diffuse Large B-Cell Lymphoma", "Transformed Small Lymphocytic Lymphoma to Diffuse Large B-Cell Lymphoma"], "Interventions" : ["Drug: Duvelisib", "Biological: Nivolumab"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This phase I trial studies the side effects and best dose of duvelisib when given together with nivolumab in treating patients with Richter syndrome or transformed follicular lymphoma. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving duvelisib and nivolumab may work better in treating patients with Richter syndrome or transformed follicular lymphoma compared to giving duvelisib or nivolumab alone. Detailed Description PRIMARY OBJECTIVES: I. To determine the maximum-tolerated dose (MTD) of duvelisib in combination with nivolumab for patients with Richter?s syndrome or transformed follicular lymphoma. SECONDARY OBJECTIVES: I. To assess preliminary efficacy of duvelisib in combination with nivolumab in Richter?s syndrome and transformed follicular lymphoma (overall response rate, progression free survival, overall survival). II. To determine the toxicity profile of duvelisib in combination with nivolumab. EXPLORATORY OBJECTIVES: I. To correlate response to duvelisib in combination with nivolumab with cytogenetic/fluorescence in-situ hybridization (FISH) abnormalities of the chronic lymphocytic leukemia (CLL) and lymphoma compartments (for patients with Richter?s syndrome) at baseline. II. To correlate response to duvelisib in combination with nivolumab with baseline deoxyribonucleic acid (DNA) mutation of CLL and lymphoma as assessed in tumor samples and cell free DNA. III. To determine changes in T, B, and natural killer (NK) cell number and function during duvelisib plus nivolumab therapy. OUTLINE: This is a dose-escalation study of duvelisib. Patients receive duvelisib orally (PO) twice daily (BID) on days 1-28 and nivolumab intravenously (IV) over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months thereafter. #Intervention - DRUG : Duvelisib - Given PO - Other Names : - 8-Chloro-2-phenyl-3-((1S)-1-(7H-purin-6-ylamino)ethyl)isoquinolin-1(2H)-one, INK-1197, IPI-145 - BIOLOGICAL : Nivolumab - Given IV - Other Names : - BMS-936558, MDX-1106, NIVO, ONO-4538, Opdivo

#Eligibility Criteria: Inclusion Criteria: * Diagnosis of CLL or small lymphocytic lymphoma (SLL) meeting International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria AND biopsy proven transformation to diffuse large B cell lymphoma (DLBCL), clinically consistent with Richter?s syndrome (RS) OR histologically diagnosed relapsed or refractory DLBCL including transformed follicular lymphoma (tFL) ineligible for or refractory to platinum containing salvage therapy for the dose escalation portion of the study. For the dose expansion phase only patients with CLL with transformation to DLBCL or tFL will be eligible * Eastern Cooperative Oncology Group (ECOG) performance status 0 <= age <= 2 * Absolute neutrophil count (ANC) >= 500/uL * Platelet count >= 30,000/uL (unless due to bone marrow involvement) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 ULN * Total bilirubin =< 1.5 ULN (unless due to liver involvement, hemolysis, or Gilbert?s disease) * Creatinine clearance >= 40 mL/min (Cockcroft-Gault estimated) * Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials. Men must agree to not donate sperm during and after the study. For females, these restrictions apply for 1 month after the last dose of study drug. For males, these restrictions apply for 3 months after the last dose of study drug * Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) or urine pregnancy test at screening. Women who are pregnant or breastfeeding are ineligible for this study * Patients must sign an informed consent document indicating that they understand the purpose of and procedures required for the study, including biomarkers, and are willing to participate in the study Exclusion Criteria: * Documented infection with human immunodeficiency virus (HIV) or chronic, active hepatitis B or C infection * Any chemotherapy or monoclonal antibodies within 14 days or kinase inhibitors (except BTKi) within 5 half-lives before cycle 1, day 1 (C1D1). BTK inhibitors may be continued until 2 days prior to C1D1. Steroids are allowed for palliation of symptoms due to lymphoma * Toxicity from previous therapy which has not resolved to grade 1 (or patient?s previous baseline) * Other active malignancies except those treated with curative intent with no active disease at the time of study entry or those felt to be at low risk of progression or recurrence over the next 2 years (such as low risk prostate cancer on active surveillance) * New York Heart Association (NYHA) class III/IV heart disease or other significant medical condition or organ system dysfunction which could compromise the subject?s safety or put the study outcomes at undue risk * Uncontrolled systemic infection * Unable to swallow capsules or significant malabsorption syndrome, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction at the time of screening * Patients who are pregnant or breastfeeding * Patients with known central nervous system (CNS) involvement by CLL or lymphoma * Patients who have underwent autologous or allogeneic stem cell transplant =< 4 weeks prior to C1D1 or have active graft-versus-host disease are excluded ##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

{ "NCT_ID" : "NCT02944617", "Brief_Title" : "Probiotic Yogurt Supplement in Reducing Diarrhea in Patients With Metastatic Kidney Cancer Being Treated With Vascular Endothelial Growth Factor-Tyrosine Kinase Inhibitor", "Official_title" : "Assessment of the Role of Bifidobacterium-Containing Food Supplement Activia™ and Bacteriomic Profiling and Other Biomarkers Associated With Vascular Endothelial Growth Factor Tyrosine Kinase Inhibitor (VEGF-TKI)-Induced Diarrhea in Patients With Metastatic Renal Cell Carcinoma (mRCC)", "Conditions" : ["Diarrhea", "Metastatic Renal Cell Carcinoma", "Stage IV Renal Cell Cancer"], "Interventions" : ["Drug: VEGF-TKI", "Dietary Supplement: Micronutrient-Fortified Probiotic Yogurt", "Other: Laboratory Biomarker Analysis"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "NONE" } }

#Study Description Brief Summary This randomized clinical trial studies how well probiotic yogurt supplement works in reducing diarrhea in patients with kidney cancer that has spread from the primary site to other places in the body (metastatic) and that are being treated with vascular endothelial growth factor-tyrosine kinase inhibitor therapy. Studying samples of blood and stool from patients who eat probiotic yogurt and those who avoid probiotic yogurt may help doctors plan better treatment. Detailed Description PRIMARY OBJECTIVES: I. To determine if adding Activia yogurt (containing Bifidobacterium lactis DN-173 010) to the diet of patients with metastatic renal cell carcinoma (mRCC) increases the level of Bifidobacterium spp in stool. SECONDARY OBJECTIVES: I. To determine if Activia reduces the incidence of diarrhea for mRCC patients treated with vascular endothelial growth factor - tyrosine kinase inhibitor (VEGF-TKI) therapy. II. To compare pre-treatment levels of circulating T regulatory (Treg) cells and levels of peripheral signal transducers and activators of transcription 3 (STAT3) in patients with and without diarrhea with VEGF-TKI therapy, and correlate with Bifidobacterium, other bacteria, and Activia. III. To determine if patients with the diarrhea in mRCC patients treated with VEGF-TKI therapy have a lower baseline of Bifidobacterium spp. IV. To assess the change in global stool bacteriomic profile of patients receiving therapy with VEGF-TKI therapy with or without Activia. V. To better assess the feasibility of stool collection and bacteriomic profiling. VI. To explore association between psychosocial symptoms (anxiety and depression) and bacteriomic profile and gastrointestinal toxicity in mRCC patients receiving VEGF-TKI therapy therapy. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive probiotic supplement Activia yogurt twice daily (QD) during weeks 2-13 of VEGF-TKI treatment. ARM II: Patients avoid any intake of yogurt or yogurt-containing foods and refrain from taking/consuming other probiotic supplements for 3 months. #Intervention - OTHER : Laboratory Biomarker Analysis - Correlative studies - DIETARY_SUPPLEMENT : Micronutrient-Fortified Probiotic Yogurt - Receive Activia yogurt - DRUG : VEGF-TKI - Must be received as standard of care chemotherapy

#Eligibility Criteria: Inclusion Criteria: * Cytologically or pathologically verified diagnosis of renal cell carcinoma (RCC) * Diagnosis of RCC that is defined as metastatic by standard criteria (American Joint Committee on Cancer [AJCC] 7th edition, 2010) * Planned treatment with any VEGF-TKI, treatment has not yet begun * Ability to understand and the willingness to sign a written informed consent * Ability to read and write English * Documented consent to participation to include the following study specific procedures: * Be able to provide up to six serial stool collections at home and deliver to FedEx location that day as per standard operating procedure * Have three 10-ml blood samples taken during a routine clinic visit * To not take probiotic supplements except as oriented * If randomized to the probiotic-supplemented group (the yogurt-based supplement Activia), be willing to comply with daily intake and record this intake as a component of a dietary log; the patient will be asked not to take any yogurt or yogurt-containing foods beyond this * If randomized to the probiotic-restricted group, agree not to consume yogurt or yogurt-containing foods * Maintain a dietary log and stool frequency log Exclusion Criteria: * Patients with a known intolerance to lactose or other constituents of Activia * Patients with irritable bowel syndrome, Crohn's disease, or other clinically significant gastrointestinal (GI) related condition that might confound the VEGF-TKI-related-diarrhea endpoint * Patients taking antibiotics or who plan to begin taking antibiotics * Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures (including compliance issues related to feasibility/logistics) ##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

{ "NCT_ID" : "NCT01807117", "Brief_Title" : "PET-MRI in Diagnosing Patients With Colon or Rectal Cancer", "Official_title" : "Evaluation of PET-MRI in Initial Staging of High Grade Rectal Cancer Patients and in the Follow up of Colorectal Cancer Patients.", "Conditions" : ["Recurrent Colon Cancer", "Recurrent Rectal Cancer", "Stage IIA Colon Cancer", "Stage IIA Rectal Cancer", "Stage IIB Colon Cancer", "Stage IIB Rectal Cancer", "Stage IIC Colon Cancer", "Stage IIC Rectal Cancer", "Stage IIIA Colon Cancer", "Stage IIIA Rectal Cancer", "Stage IIIB Colon Cancer", "Stage IIIB Rectal Cancer", "Stage IIIC Colon Cancer", "Stage IIIC Rectal Cancer", "Stage IVA Colon Cancer", "Stage IVA Rectal Cancer", "Stage IVB Colon Cancer", "Stage IVB Rectal Cancer"], "Interventions" : ["Procedure: magnetic resonance imaging", "Procedure: computed tomography", "Radiation: fludeoxyglucose F 18", "Procedure: positron emission tomography"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "DIAGNOSTIC", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This pilot clinical trial studies positron emission tomography (PET)-magnetic resonance imaging (MRI) and PET-computed tomography (CT) as diagnostic imaging in patients with colon and/or rectal cancer. New diagnostic imaging procedures, such as PET-MRI, may help find and diagnose rectal cancer or recurrence of colorectal cancer Detailed Description PRIMARY OBJECTIVES: I. To test the diagnostic performance of PET- MRI in the staging of preoperative high-grade rectal cancer patients, defined by T3 stage or higher or N1 stage or higher or presence of metastasis, that are referred to PET-CT and MRI. II. To test the diagnostic performance of PET-MRI the follow up of colorectal cancer patients that are referred to PET-CT with or without a diagnostic MRI request by their physicians. SECONDARY OBJECTIVES: I. To test different attenuation correction MR sequences and novel diagnostic MR sequences. OUTLINE: Patients undergo fludeoxyglucose F 18 PET-CT and PET-MRI. #Intervention - PROCEDURE : positron emission tomography - Undergo fludeoxyglucose F 18 PET-CT and PET-MRI - Other Names : - FDG-PET, PET, PET scan, tomography, emission computed - PROCEDURE : computed tomography - Undergo fludeoxyglucose F 18 PET-CT and PET-MRI - Other Names : - tomography, computed - PROCEDURE : magnetic resonance imaging - Undergo fludeoxyglucose F 18 PET-CT and PET-MRI - Other Names : - MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging - RADIATION : fludeoxyglucose F 18 - Undergo fludeoxyglucose F 18 PET-CT and PET-MRI - Other Names : - 18FDG, FDG

#Eligibility Criteria: Inclusion Criteria: * Either having a T3 (the cancer has grown through the muscularis propria and into the outermost layers of the colon or rectum but not through them) or higher, node positivity or metastatic lesion in the context of rectal cancer or being studied for colorectal cancer follow up, independent of the renal function * PET-CT should be requested by a referring physician; in the case of having an MR requested as well, it will be reported from the MRI images generated in the PET-MRI * Stable physical medical conditions to undergo a MRI * Informed consent must be given and signed prior to study enrollment Exclusion Criteria: * Refuse to give and/or sign the informed consent * Subjects who do not meet the above mentioned inclusion criteria * Subjects who have a pacemaker * Subjects who have a metallic prostheses either in the pelvis or in the abdomen that will interfere with the MR imaging of that anatomical area * Subjects who suffer from claustrophobia * Pregnant women * Cognitive impairment that affects the subject's ability to give consent ##Sex : ALL ##Ages : - Minimum Age : 22 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT01490749", "Brief_Title" : "Trial of XELOX Followed by Radiation Combined With Carboplatin and RAD001 for Esophageal Cancer", "Official_title" : "Phase I/IIB Study of Induction Chemotherapy With XELOX, Followed by Radiation Therapy and Dose Escalation of RAD001 in Patients With Esophageal Cancer", "Conditions" : ["Esophageal Cancer", "Neoplasms, Esophageal"], "Interventions" : ["Drug: Carboplatin", "Drug: XELOX", "Drug: RAD001", "Radiation: Radiation"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The purpose of this study is to test the drug RAD001 in combination with another chemotherapy drug, Carboplatin, as well as radiation therapy in the treatment of esophageal cancer. Because RAD001 has not been used in this combination before, it is not clear which dose will be best when used in combination. The standard of care for patients who have esophageal cancer that has not moved to other areas of the body (non-metastatic) includes a combination of chemotherapy, radiation therapy and possibly surgery. If the patient chooses to participate in this study, the patient will receive chemotherapy and radiation therapy. The patient will possibly also have surgery to have the cancer removed. This decision will be made by the treating physicians. All of the chemotherapy the patient will receive on the study is considered standard chemotherapy for esophagus cancer. The investigators do not know as of yet if the drug called RAD001 will help improve the treatment for patients with this disease. RAD001 is a pill that has been used in many other types of cancer and has been proven to be effective in other cancers such as kidney cancer. Detailed Description Esophageal cancer is the sixth most common cause of cancer-related death worldwide. Recent medical advances have led to small improvements in survival, but the overall rate of survival remains low, making new treatment approaches necessary. Chemotherapy drugs and radiation therapy are often both used in treating esophageal cancer. The combination of oxaliplatin and capecitabine (XELOX) is a commonly used chemotherapy combination. Sometimes chemotherapy is given as an 'induction' therapy, before the radiation is given. The drug RAD001 is a targeted drug that acts specifically on a protein inside cells (called mTOR), which is important for cancer development. The combination of RAD001 and radiation therapy has been shown to improve anti-cancer effects. This study will look for the ideal dose of RAD001 when given in combination with radiation therapy after induction chemotherapy with XELOX, and test the anticancer effects of this treatment approach in patients with esophageal cancer. #Intervention - DRUG : RAD001 - Dose escalation for Phase I; dose for Phase II to be determined after Phase I is completed. - Other Names : - Everolimus - DRUG : XELOX - Patients will receive two cycles of XELOX. - Other Names : - Oxaliplatin and capecitabine, Eloxatin and Xeloda - DRUG : Carboplatin - Given on a 3 weeks on and 1 week off schedule. - Other Names : - Paraplatin - RADIATION : Radiation - 1.8 Gy to 36 Gy; 3 fields or laterals to 50.4 Gy.

#Eligibility Criteria: Inclusion Criteria: * Patients must have histologically or cytologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal (GE) junction. * Patients can have disease that is resectable or unresectable. * Patients must not have had prior chemotherapy or radiation therapy for esophageal cancer. * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. * Age >= 18. * Adequate bone marrow, liver and renal function as assessed by the following: * Absolute neutrophil count (ANC) >= 1500/mm³. * Platelet count >= 100,000/mm³. * Total bilirubin <= 1.5 x upper limit of normal (ULN). * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 2.5 x ULN (<= 5 x ULN for patients with liver involvement). * Creatinine <= 1.5 x ULN. * Fasting serum cholesterol <= 300 mg/dL OR <= 7.75 mmol/L AND fasting triglycerides <= 2.5 x ULN. NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication. * Women of childbearing potential must have a negative pregnancy test prior to first receiving investigational product. Sexually active women of childbearing potential (WOCBP) must use an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized. All WOCBP should be instructed to contact the Investigator immediately if they suspect they might be pregnant (e.g., missed or late menstrual period) at any time during study participation. * Patient must be willing to sign informed consent. Exclusion Criteria: * Patients currently receiving other investigational agents. * Patients with known distant metastases. * Patients who have received prior treatment with an mammalian target of rapamycin (mTOR) inhibitor (sirolimus, temsirolimus, everolimus). * Patients with a known hypersensitivity to RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus) or to its excipients. * Known hypersensitivity to oxaliplatin, other platinum-containing compounds. * Patients with known brain metastases. * Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as a known history of HIV seropositivity. * History of active hepatitis B or C. * Co-administration with strong inhibitors of cytochrome P450 3A4 isoenzyme (CYP3A4) (e.g., ketoconazole, itraconazole, ritonavir) or P-glycoprotein (PgP). * Patients with an active, bleeding diathesis. * Patients with significant intercurrent medical illness (including New York Heart Association [NYHA] class III or IV heart disease, significant arrhythmias requiring medication, symptomatic coronary artery disease, myocardial infarction) within the previous 6 months. ##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

{ "NCT_ID" : "NCT01755390", "Brief_Title" : "A Dose Finding Study of XRP6258 in Patients With Advanced Solid Tumors", "Official_title" : "A Phase I Dose Finding Study of XRP6258 Administered as a Weekly 1-hour Intravenous Infusion to Patients With Advanced Solid Tumors", "Conditions" : ["Advanced Solid Tumor"], "Interventions" : ["Drug: Cabazitaxel (XRP6258)"], "Location_Countries" : ["France", "Spain"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE1"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NON_RANDOMIZED", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary Primary Objective: - To determine the maximum tolerated dose (MTD) and the dose-limiting toxicity (DLT) of XRP6258 when given as a weekly 1-hour intravenous (i.v.) infusion for the first 4 consecutive weeks of each 5-week treatment cycle (Day 1, Day 8, Day 15, Day 22 of each 5-week treatment cycle). Secondary Objectives : * To define the safety profile of the drug * To establish the recommended dose and time interval for future Phase II trials * To determine the pharmacokinetic (PK) profile of XRP6258 in man * To assess the absolute oral bioavailability of XRP6258 at the i.v. recommended dose (following Protocol Amendment No. 2) * To look for evidence of antitumor activity Detailed Description The duration of the study will include the following periods: * Pretreatment: 28 to 7 days before first infusion * Treatment: Weekly for the first four consecutive weeks during 5-week treatment cycle * Post-treatment: 3 - 4 weeks after last infusion. Treatment may be continued until disease progression or unacceptable toxicity or patient refusal. #Intervention - DRUG : Cabazitaxel (XRP6258) - Pharmaceutical form: infusion solution Route of administration: Intravenous - Other Names : - Jevtana

#Eligibility Criteria: Inclusion criteria: * Signed informed consent prior to beginning protocol specific procedures * Histologically proven cancer at the first diagnosis. At study entry, it was desirable but not required to have histological or cytological proof of metastasis in the case of a 1 single metastatic target lesion. * Advanced neoplastic disease that was refractory to conventional treatment or for which no standard therapy existed * Progressive disease * Age 18 <= age <= 70 years * ECOG (Eastern Cooperative Oncology Group) performance status of 0 to 2 * Off previous anticancer (radio- or chemo-) therapy for at least 4 weeks and 6 weeks if prior nitrosoureas, mitomycin C; recovery from the toxic effects of prior treatment (Grade <=1, except alopecia any grade) * Off previous immunotherapy for at least 1 week provided that patients did not have any residual signs of any toxicity * Adequate organ function including: neutrophils >=2.0 × 109/L; platelets >=100 × 109/L, creatinine <120 μmol/L (if borderline creatinine values, the creatinine clearance had to be >=60 mL/min); total bilirubin within normal limit; alanine aminotransferase (ALT)/aspartate aminotransferase (AST)/alkaline phosphatase (ALP) <=2.5-fold the upper normal limits of the institutional norms (ALP <=2.5 UNL) * Patients registered in this trial had to be treated and followed at the participating centers * Patients who had received previous treatment with paclitaxel or docetaxel could be included provided that they did not have any residual signs of taxane toxicity (except alopecia any grade and peripheral neuropathy Grade 1) Exclusion Criteria: * Hematological malignancies * Pregnant or lactating women or women of childbearing potential (eg, not using adequate contraception) * Symptomatic brain metastases * Previous extensive radiotherapy (>20% of bone marrow area) * Current peripheral neuropathy of any origin including significant residual symptoms due to the use of eg, vinca-alkaloids or platinum >=Grade 2 according to the National Cancer Institute common terminology criteria for adverse events. * Other serious illness or medical conditions: * Congestive heart failure or angina pectoris even if medically controlled, previous history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or arrhythmias * Existence of significant neurological or psychiatric disorders including dementia or seizures * Active infection * Uncontrolled peptic ulcer, unstable diabetes mellitus, or other contraindications for the use of corticosteroids * Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to patient registration * Concurrent treatment with any other anticancer therapy * Concomitant radiotherapy * Concomitant treatment with corticosteroids. However, patients receiving chronic treatment with corticosteroids (<=20 mg of methylprednisolone or <=4 mg of dexamethasone or equivalent dose of other corticosteroids), for whatever reason, were eligible. * More than 2 prior chemotherapy regimens containing mitomycin C or nitrosoureas * More than 2 prior chemotherapy regimens for advanced disease * Prior history of severe allergic reaction to docetaxel or paclitaxel * Prior intensive chemotherapy with autologous stem cell rescue The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. ##Sex : ALL ##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

{ "NCT_ID" : "NCT04750434", "Brief_Title" : "PET MRI as a Staging Tool for Head and Neck Cancer", "Official_title" : "PET MRI as a Staging Tool for Head and Neck Cancer", "Conditions" : ["Head Cancer", "Neck Cancer"], "Location_Countries" : ["United States"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary To explore the use of PET/MRI in the staging and pretreatment evaluation of patients with head and neck cancer and to compare this modality to standard PET/CT imaging. Detailed Description This study is a prospective clinical study whereby an emerging technology, PET/MRI will be compared to a more standard imaging modality, PET/CT, using newly diagnosed head and neck cancer patients as subjects. PET/MRI will also be used in this study to explore the merits of this new technology in determining extent of disease, functional impact, and potential treatment outcome. In this study, subjects suitable for enrollment will be identified by the investigators involved in the study. These subjects will be identified through contact with these investigators and referred for enrollment per protocol. This protocol will include determining enrollment suitability based on inclusion and exclusion criteria. Once accepted as a candidate for the study, the newly diagnosed head and neck cancer patients will undergo both PET/CT and PET/MRI imaging within one week of each other. These studies will then be reviewed by a radiologist specializing in Head and Neck radiology familiar with PET imaging. The studies will be compared for any imaging differences. The imaging findings will then be correlated with pathological findings after surgery to determine if there are any consistent findings that correlate with adverse pathological findings, if found. The specific imaging data points to be determined by a radiologist will be tumor and metastatic disease size, SUV uptake, specific anatomic structures involved with tumor, imaging irregularities and characteristics of those imaging irregularities of the involved structures locally and regionally (if present), imaging characteristics of the different phases of MRI (T1, T2, etc.), and any other notable imaging characteristic.

#Eligibility Criteria: Inclusion Criteria: * Active head and neck cancer that require PET/CT regardless of the point of treatment * TNM staging I or II Exclusion Criteria: * Patients whose primary treatment option is chemotherapy or radiation therapy (not surgical) * Implanted pacemakers * Intracranial aneurysm clips * Cochlear implants * Certain prosthetic devices * Implanted drug infusion pumps * Neurostimulators * Bone-growth stimulators * Certain intrauterine contraceptive devices; or * Any other type of iron-based metal implants. * MRI should not also be used on persons with the presence of internal metallic objects such as bullets or shrapnel, as well as surgical clips, pins, plates, screws, metal sutures, or wire mesh. * Subject with breast tissue expanders. ##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

{ "NCT_ID" : "NCT01719757", "Brief_Title" : "PROspective Non-interventional Open laBEl Trial for TARGIN in Korean Patients With Cancer Pain", "Official_title" : "A 4-week, Open Label, Multi-center, Prospective, Single-arm, Non-interventional Phase IV Study to Evaluate the Efficacy of Targin for the Treatment of Korean Patients With Cancer Pain Under Conditions of Daily Practice", "Conditions" : ["Cancer"], "Interventions" : ["Drug: Oxycodone/Naloxone"], "Location_Countries" : ["Korea, Republic of"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["PHASE4"], "Primary_Purpose" : "TREATMENT", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary The aim of the study is to evaluate the efficacy of TARGIN administration as an analgesic to Korean patients treated with opioid analgesics for moderate-to-severe cancer pain under conditions of daily practice. Detailed Description An open-label, multi-center, nonrandomized, prospective, non-interventional, observational phase IV trial. At the first visit, a detailed medical history is taken, including previous analgesics and concomitant treatment. After inclusion, patients enter a 4-week observation period during which they will receive bid of TARGIN 10/5mg and/or 20/10mg. The dose adjustments of TARGIN as well as of analgesic co-medication, rescue-medication and other treatments (e.g. laxatives) can be performed at any time-point during the observation period by the physician in dependence of medical demand. The asymmetric dose is allowed during the observation period by the physician's judgment. (e.g. 10/5 mg in the morning and 20/10 mg in the evening). Data are gathered using interview-administered questionnaires at baseline (visit 1) and study end (visit 2). During the observation period, unscheduled visits are allowed after the first visit due to inadequate pain control or occurrence of adverse events. #Intervention - DRUG : Oxycodone/Naloxone - Twice daily - Other Names : - Targin

#Eligibility Criteria: Inclusion Criteria: * Male or female cancer patients 20 years or older * Cancer related pain that requires treatment with continuous around-the-clock strong opioid analgesic * Moderate to severe pain intensity (NRS pain score >=4) * Opioid naïve patients or patients not treated with strong opioids (Only except occasional PRN) within 13 months or patients who has been on weak opioids * Ability to communicate effectively with the study personnel regarding pain intensity, constipation assessment, final assessment of overall efficacy and tolerability * Subject who provide signed and dated written voluntary informed consent Exclusion Criteria: * Pregnant or nursing (lactating) women * Have previously received treatment with Targin * Patient with evidence of significant structural/functional abnormalities of GI tract which is not appropriate for oral medicine administration * Any history of hypersensitivity to Oxycodone and Naloxone or any excipients * Patients with significant respiratory depression * Patients with acute or severe bronchial asthma or hypercarbia * Any patient who has or is suspected of having paralytic ileus * Severe Chronic obstructive pulmonary disease, pulmonary heart disease * Targin product contains lactose. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take * Patients with moderate and severe hepatic impairment * Abnormal aspartate aminotransferase (AST; SGOT), alanine aminotransferase (ALT; SGPT), or alkaline phosphatase levels (>2.5 times the upper limit of normal, it is allowed >5 times the upper limit of normal in case of transition in liver) or an abnormal total bilirubin and/or creatinine level(s) (greater than 1.5 times the upper limit of normal) * Any situation where opioids are contraindicated * With a life expectancy < 1 month * Any situation where opioids are contraindicated * Mainly pain originated other than cancer or cancer related conditions (eg. Musculoskeletal pain, inflammatory pain, diabetic polyneuropathy) * Patients with known or suspected unstable brain metastases or spinal cord compression that may require changes in steroid treatment throughout the duration of the study * Patients with uncontrolled seizures * Requiring interventional treatment for pain such as neurodestructive procedure or regional infusion * With a history of alcohol abuse within 6 months of screening * With a history of illicit drug abuse within 6 months of screening * Patients with increased intracranial pressure * Having used other investigational drugs at the time of enrollment, or within 30 days. ##Sex : ALL ##Ages : - Minimum Age : 20 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT02403037", "Brief_Title" : "Auricular Acupressure for Chemotherapy-Induced Nausea and Vomiting in Female Breast Cancer Patients", "Official_title" : "The Effects of Auricular Acupressure on Chemotherapy-Induced Nausea and Vomiting in Female Breast Cancer Patients: A Pilot Randomized Controlled Trial", "Conditions" : ["Breast Neoplasms", "Nausea", "Vomiting"], "Interventions" : ["Device: True auricular acupressure", "Device: Sham auricular acupressure", "Drug: Standard anti-emetic treatment (5-HT3 receptor antagonists and/or Dexamethasone)"], "Location_Countries" : ["China"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "TREATMENT", "Allocation" : "RANDOMIZED", "Interventional Model" : "PARALLEL", "Masking" : "TRIPLE" } }

#Study Description Brief Summary To evaluate the feasibility of a three-parallel-arm, placebo-controlled randomized trial using a standard auricular acupressure protocol for managing nausea and vomiting in a homogenous group of female breast cancer patients undergoing chemotherapy. The null hypotheses of this study are: (1) There will be no significant difference in acute/delayed nausea and vomiting among groups during the intervention period; (2) There will be no significant difference in anticipatory nausea and vomiting among groups before the second cycle of chemotherapy; (3) There will be no significant difference in quality of life status among groups at the end of the first cycle of chemotherapy. Detailed Description Chemotherapy-induced nausea and vomiting (CINV) is one of the most common and distressing side-effects among cancer patients undergoing chemotherapy. Despite steady progresses in antiemetic prophylaxis and treatment during the past decades, approximately half of cancer patients receiving moderately to highly emetogenic chemotherapy still experience significant nausea and vomiting. Considering the facts that CINV is difficult to be completely controlled by antiemetics along, healthcare professionals has explored the role of non-pharmacological interventions as adjunctive therapy for controlling CINV. Among which, auricular therapy (AT) is a promising approach but the evidence has still not been concluded. The aim of this study is to test the feasibility of a randomized controlled trial using auricular acupressure protocol for managing nausea and vomiting in female breast cancer patients undergoing chemotherapy. The objectives of this study will be: (1) to pilot the methodological procedure of the randomized controlled trial using a standard auricular acupressure protocol for controlling CINV; (2) to determine the recruitment rate and attrition rate during the whole study period; (3) to determine the feasibility of the study questionnaires and auricular acupressure protocol to the study participants; (4) to identify potential adverse events associated with auricular acupressure; (5) to preliminarily examine the effects of auricular acupressure on CINV and QoL in female breast cancer patients receiving chemotherapy; (6) to explore patients' experience in completing the trial and receiving the intervention; and (7) to refine the study protocol for a future multicenter, large-scale randomized controlled trial. A three-parallel-arm, placebo-controlled randomized pilot study will be adopted. One hundred and fourteen breast cancer patients scheduled to receive the first cycle of chemotherapy will be recruited from three provincial hospitals in Fuzhou, China, and will be randomly assigned to one of the three groups: the true AT group, the sham AT group or the standard care group. Participants in the true AT group will receive standard anti-emetic medications plus a 5-day auricular acupressure at the specific ear acupoints, participants in the sham AT group will receive standard anti-emetic medications plus a 5-day auricular acupressure at the same acupoints as in the true AT group without any acupoint stimulation, while participants in the standard care group will only be provided with the standard anti-emetic medications. The feasibility outcomes will be the recruitment rate and consent rate during the recruitment stage, the attrition rate during the whole study period, feasibility of the study questionnaires and auricular acupressure protocol to the study participants, and AT-related adverse events. The future main study outcomes will also be measured including acuteCINV, delayed CINV, anticipatory CINV, and quality of life. After completing the pilot clinical trial, a nested qualitative interview will be conducted to explore participants' experience in completing the trial and receiving the intervention. #Intervention - DEVICE : True auricular acupressure - A 5-day auricular acupressure at the specific ear acupoints using vaccaria seeds. - Other Names : - Auricular tape with vaccaria seeds - DEVICE : Sham auricular acupressure - A 5-day sham auricular acupressure at the same acupoints as in the true auricular acupressure arm using Junci Medulla but no pressure will be applied. - Other Names : - Auricular tape with Junci Medulla - DRUG : Standard anti-emetic treatment (5-HT3 receptor antagonists and/or Dexamethasone) - 5-HT3 receptor antagonists and/or Dexamethasone will be administered to manage chemotherapy-induced nausea and vomiting. - Other Names : - 5-HT3 receptor antagonists and/or Dexamethasone

#Eligibility Criteria: Inclusion Criteria: * Adult female patients aged above 18 years; * A diagnosis of breast cancer stage I-III; * Chemotherapy- naive; * Auricular therapy-naive; * Be able to communicate in Chinese mandarin; * Have at least completed a primary school education; * Agree to participate in the study and be willing to give written informed consent; * Be scheduled to receive the first cycle of chemotherapy with moderately-high to highly emetogenic potentials; * Be provided with standard antiemetic medications during chemotherapy. Exclusion Criteria: * Extremely weak, disabled or immunocompromised cancer patients; * Be unable to follow the study instructions to do AT intervention or other research procedures; * Have concurrent radiotherapy or other kinds of antineoplastic therapy; * Currently take part in clinical studies on anti-emetic medications or other kinds of non-pharmacological interventions to control CINV, or other studies which are believed to produce potential interactions with this AT trial; * Have other health problems which may affect the symptoms of CINV such as gastrointestinal disease, liver disease, migraine, tinnitus and Ménière's disease, etc.; * Ear skin problems which are not appropriate for auricular acupressure including ear infections, ear scars and rashes, ear frostbite, and ear abscess, etc. ##Sex : FEMALE ##Ages : - Minimum Age : 18 Years - Age Group (Child: birth-17, Adult: 18-64, Older Adult: 65+) : ADULT, OLDER_ADULT ##Accepts Healthy Volunteers: No

{ "NCT_ID" : "NCT04822389", "Brief_Title" : "Telerehabilitation and Lymphoma Patients", "Official_title" : "Effect of the Physical Exercise Training Using Telerehabilitation Among Lymphoma Patients: A Pilot Study", "Conditions" : ["Lymphoma", "Rehabilitation"], "Interventions" : ["Device: Telerehablitation using heart rate monitor"], "Location_Countries" : ["Czechia"], "Study_Design" : { "Study_Type" : "INTERVENTIONAL", "Phase" : ["NA"], "Primary_Purpose" : "SUPPORTIVE_CARE", "Allocation" : "NA", "Interventional Model" : "SINGLE_GROUP", "Masking" : "NONE" } }

#Study Description Brief Summary This study aims to examine the feasibility and effect of a home-based short-term telerehabilitation exercise intervention using heart rate monitor and internet platform in patients with lymphoma. Detailed Description Fifteen lymphoma cancer patients post-treatment (except adjuvant treatment) will be enrolled in the study. Cardiorespiratory fitness (peak oxygen consumption), adverse events, body composition and adherence to exercise prescription will be evaluated at baseline, 12-week, and year after enrollment. #Intervention - DEVICE : Telerehablitation using heart rate monitor - Eligible participants will undergo 12 weeks of physical exercise using a heart rate monitor and internet platform at home. The participants will regularly (minimum once per week) upload the exercise data from the heart rate monitor into the internet platform. An exercise telerehabilitation session consists of the warm-up phase, aerobic phase (30 - 50 minutes gradually increasing exercise duration; heart rate zone based on baseline cardiopulmonary exercise test) and cool-down phase. The exercise training period is set to 3 times a week for 12 weeks. Study participants will receive user guides developed by research team with detailed instructions regarding equipment set-up, training protocol, and contact information. Also, participants will receive weekly phone calls from week 0 to week 12 to monitor adverse events, encourage compliance and adherence to the study protocol, address any subject questions or concerns, and collect information regarding participants' current symptomatology.

#Eligibility Criteria: Inclusion Criteria: * Lymphoma patients post-treatment (except ongoing adjuvant treatment) * Post-treatment period not exceeding 3 months * Internet connection at home * Literacy with information and communication technology * Patients who agreed with informed consent Exclusion Criteria: * Inability to perform a cardiopulmonary exercise test * Psychological severe or cognitive disorders * Contraindications for cardiopulmonary exercise testing * Other exercise limitations (musculoskeletal disorders) * Planned intervention or operation * Participants who are enrolled in or participate in other rehabilitation program * Participants who plan to be or are included in other studies ##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

{ "NCT_ID" : "NCT01265992", "Brief_Title" : "Study to Assess Patient Management Practices and Quality of Life With Paricalcitol Capsules in the Treatment of Secondary Hyperparathyroidism in Stage 3-5 Chronic Kidney Disease Patients Not Yet on Dialysis", "Official_title" : "Post Marketing Observational Study to Assess Patient Management Practices and Quality of Life With the Capsules Form of Paricalcitol in the Treatment of SHPT in Stage 3 - 5 Chronic Kidney Disease Patients Not Yet on Dialysis Under Conditions of Usual Clinical Care (CAPITOL)", "Conditions" : ["Secondary Hyperparathyroidism", "Chronic Kidney Disease"], "Location_Countries" : ["Sweden"], "Study_Design" : { "Study_Type" : "OBSERVATIONAL", } }

#Study Description Brief Summary Paricalcitol capsules (Zemplar®) received marketing authorization in Sweden in late 2007 for the prevention and treatment of secondary hyperparathyroidism in patients with Stage 3 \& 4 Chronic Kidney Disease (CKD). Accordingly, additional data is needed to evaluate the effectiveness and safety of paricalcitol therapy under conditions of usual clinical care in Sweden. This observational study is designed to collect data to evaluate safety and effectiveness during 6 months of therapy with paricalcitol capsules prescribed for patients with CKD Stages 3-5 not yet on dialysis. Data will also be collected on patient quality of life and costs associated with patient care. Detailed Description This observational study is designed to collect data to evaluate safety and effectiveness during 6 months of therapy with paricalcitol capsules prescribed in accordance with the terms of the marketing authorization for patients with Chronic Kidney Disease (CKD) Stages 3-5 not yet on dialysis. Data will also be collected on patient quality of life and costs associated with patient care. A retrospective chart review of patient laboratory and medication history will provide historical data to determine drivers for initiation of paricalcitol therapy. The primary goal of this post-marketing observational study (PMOS) is to further characterize the prescribing habits and patient management practices of physicians prescribing paricalcitol capsules and to assess the metabolic safety and effectiveness of paricalcitol capsules for the treatment of secondary hyperparathyroidism in Stage 3-5 CKD patients not yet on dialysis under conditions of usual clinical care. Focus will be to examine the practice of dose titration in early stages of CKD, understand real-world management of intact parathyroid hormone levels, understand real-world incidence and management of abnormalities in serum calcium and phosphate, and to examine patient bone and mineral profiles and medical history to understand drivers for paricalcitol capsules use. Patients prescribed paricalcitol therapy for the first time will be asked to participate in the study. Enrolled patients will be followed for 6 months.

#Eligibility Criteria: Inclusion Criteria: Patients must sign the Informed Consent Form prior to inclusion into the study * Patients should satisfy the Swedish Summary of Product Characteristics (SPC) for paricalcitol capsules at www.fass.se * Patients must be >= 18 years with a diagnosis of secondary hyperparathyroidism associated with Chronic Kidney Disease (CKD) Stages 3 - 5 (estimated Glomerular Filtration Rate between 10 <= age <= 59 by Modification of Diet in Renal Disease) but not yet on dialysis * Patients should be in stable condition and have a life expectancy of at least 6 months * Patients should not be expected to be transplanted or initiate dialysis for at least 6 months Exclusion Criteria: * Patients with CKD receiving dialysis * Patients contraindicated for paricalcitol capsules as described in the SPC * Treatment with paricalcitol more than 20 days prior to study enrollment * History of drug or alcohol abuse within 6 months prior to inclusion * History of non-compliance with medication or a medical history (i.e. psychiatric) that could enhance non-compliance with medication as determined by the investigator ##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