Kornimate/medical-research-clean huggingface dataset:
treatment positioning in vulvar cancer radiation therapy

Conditions: Radiation Toxicity

Summary: the study investigators will conduct a prospective study on patients with non-metastatic vulvar cancer who will receive radiation treatment using volumetric arc therapy (vmat) modality with curative intent. our aim is to compare straight-leg versus frog-leg position in terms of rtog acute skin toxicity. also, the study investigators will evaluate if positioning has an impact on the total treatment time and deviation on cone beam ct (cbct) that might warrant re-simulation and consequently re-planning.

vulvar cancer is a rare tumor with a prevalence of about 3-5% of gynecological malignancies with squamous cell carcinoma being the most common histopathologic subtype. it is more common among elderly and postmenopausal women. surgery is the cornerstone for the management of patients with early stage vulvar cancer. radiotherapy is an integral part of the management of vulvar cancer both in the definitive and adjuvant settings. several studies have shown that intensity modulated radiotherapy imrt is associated with better locoregional control compared with 3-dimensional conformal radiotherapy 3dcrt. in addition, it is associated with dosimetric advantage and better sparing of the organs at risk. historically, frog-leg position was the standard to provide better access for electron boost in conventional era. after evolution of inverse planning, electron boost is not further needed. some centers have adopted straight-leg position. there is paucity of literature regarding vulvar cancer in general and there is lack of data addressing radiation therapy treatment position specifically. the study investigators will conduct a prospective study on patients with non-metastatic vulvar cancer who will receive radiation treatment using volumetric arc therapy (vmat) modality with curative intent. our aim is to compare straight-leg versus frog-leg position in terms of rtog acute skin toxicity. also, the investigators will evaluate if positioning has an impact on the total treatment time and deviation on cone beam ct (cbct) that might warrant re-simulation and consequently re-planning. if both positions proved to be similar in terms of skin toxicity, then the investigators will adopt supine position in the treatment of all patients with vulvar cancer. it will be more comfortable position, and so more reproducible and this reproducibility will be reflected on better treatment outcomes.

Eligibility criteria:
inclusion criteria: * age \>= 18 years * ecog ps = 0-1 * women with bx confirmed vulvar cancer figo stage i-iva (treated with curative intent) exclusion criteria: * patients whom radiotherapy plans do not cover inguinal lymph nodes will be excluded. vulnerable patients will be excluded (pregnant)
evaluation of medical practice in the management of bone metastases after injectable bone antiresorptive treatment, and its influence on quality of life

Conditions: Tumor With Bone Metastasis

Summary: to evaluate the current medical practice and its influence on health-related quality of life, in patients who are treated with injectable bone antiresorptive drugs (biphosphonates or denosumab) for at least one year.

this protocol will evaluate the pursuit of injectable bone antiresorptive treatments or their switch to oral biphosphonates, or treatment stop, in the contexte of medical practice. the primary end-point is the health-related quality of life (qol). secondary endpoints are safety, overall survial, the impact of toxicities of the treatment on qol, and the description of supportive care.

Eligibility criteria:
inclusion criteria: * patient with histologically proven tumor with bone metastasis, single or multiple (with or without metastasis extra-osseous) * patients treated with injectable bone antiresorptive therapy for 12 months or more * signed written informed consent exclusion criteria: * patient with any medical or psychiatric condition or disease which would make the patient inappropriate to complete quality of life questionaries * patient under guardianship, curator or under the protection of justice, pregnant or breast-feeding women
kokon consultation on complementary medicine in oncology - a pilot study

Conditions: Breast-cancer

Summary: the aim of the study is to investigate the effect of a consultation training program for physicians on the quality of their consultations of breast cancer patients regarding complementary medicine. we assume that the training program might enhance the communication of relevant information, empathy of the physicians or satisfaction with the consultation.


Eligibility criteria:
inclusion criteria for physicians: * age \>18 years * working in a breast center of comprehensive cancer center * able to consult 10 patients within working hours * training group: able to participate in on-site-training * not primarily treating the patients that are consulted * good language skills (for consultations) * informed consent inclusion criteria for patients: * age \> 18 years * female * diagnosis of breast-cancer * patient in the participating center * good language skills (for consultations) * informed consent

Keywords: complementary therapies consultants medical oncology breast-cancer education
study to determine the response and effectiveness of rsd1235 in subjects with atrial fibrillation or atrial flutter

Conditions: Atrial Flutter; Atrial Fibrillation

Summary: the purpose of this study is to demonstrate the effectiveness of rsd1235 compared with placebo, in the conversion of atrial fibrillation or atrial flutter to sinus rhythm.


Eligibility criteria:
inclusion criteria: * atrial flutter or atrial fibrillation that has been sustained for greater than 3 hours and up to 45 days exclusion criteria: * myocardial infarction, acute coronary syndrome or cardiac surgery within 30 days prior to randomization

Keywords: atrial flutters atrial fibrillations rsd1235
anti-reflux mucosectomy (arms) is a useful therapy for refractory gastroesophageal reflux disease (rgerd)

Conditions: Refractory Gastroesophageal Reflux Disease

Summary: anti-reflux mucosectomy (arms) may be a new therapy for refractory gastroesophageal reflux disease (rgerd). the aim of the present study is to explore the safety and efficacy of arms.


Eligibility criteria:
inclusion criteria: 1. full sufficiency in literacy 2. be off proton pump inhibitor, antacids and prokinetics ≥ 2 weeks 3. refractory gastroesophageal reflux disease exclusion criteria: 1. severe heart, lung, and cerebrovascular disease 2. severe hematopoietic system disease 3. abnormal blood coagulation function 4. oropharyngeal abnormalities 5. severe spine malformation 6. in pregnancy and lactation at present, or plan to become pregnant within 2 years 7. severe inflammation or huge ulcers in stomach 8. mental and psychological disorde

Keywords: anti-reflux mucosectomy,refractory gastroesophageal reflux disease,safety,efficacy
extension study to provide adjuvant treatment following neoadjuvant treatment and surgical resection in protocol tx05-03

Conditions: HER2-positive Breast Cancer; Early-stage Breast Cancer; Breast Cancer; Breast Neoplasms; Stage II Breast Cancer; Stage IIIA Breast Cancer

Summary: this is an extension study to provide adjuvant treatment with single agent herceptin or tx05 and assess continued safety and immunogenicity in subjects with her2-positive early breast cancer following neoadjuvant treatment and surgical resection in protocol tx05-03.


Eligibility criteria:
inclusion criteria: * signed written informed consent. * females ≥ 18 years of age. * completed neoadjuvant treatment (regardless of treatment arm) in the tx05/ herceptin neoadjuvant study and the investigator believes the subject requires continued access to single agent trastuzumab in order to continue deriving clinical benefit. * successfully undergone surgical resection of their primary tumor with no evidence of residual disease (as determined by local assessment) and no other adjuvant therapy, other than trastuzumab, is planned. however, subjects will be allowed to receive hormonal therapy if they have hormone receptor positive tumors. subjects will also be allowed to receive adjuvant radiation therapy, if required by their treating physician. * able to comply with the study protocol. * female subjects of childbearing potential must have a negative serum pregnancy test within 14 days of first administration of study drug and agree to use effective contraception (hormonal contraceptive, intrauterine device, diaphragm with spermicide, or condom with spermicide) throughout the study period and for 7 months after last administration of study drug. exclusion criteria: * breast cancer metastases or residual disease post operatively (as determined by local assessment). * history or presence of a medical condition or disease that in the investigator's opinion would place the subject at an unacceptable risk for study participation. * lactating or pregnant female. * women of childbearing potential who do not consent to use highly effective methods of birth control (e.g. true abstinence \[periodic abstinence {e.g. calendar ovulation, symptothermal, post-ovulation methods} and withdrawal are not acceptable methods of contraception\], sterilization, or other non-hormonal forms of contraception) during treatment and for at least 7 months after the last administration of study drug. subjects must agree to not breast-feed while receiving study drug. * any condition that in the opinion of the investigator represents an obstacle for study conduct and/or represents a potential unacceptable risk for subjects.
long term results of the use of oxybutynin for the treatment of hyperhidrosis

Conditions: Hyperhidrosis

Summary: evaluate the long term efficacy and side effects of oxybutynin in the treatment of hyperhidrosis.

this retrospective study aims to evaluate the medical charts of patients who were treated with oxybutynin for at least six months for primary hyperhidrosis. the investigators variables of interest are: (1) quality of life before pharmacological therapy and after six weeks, (2)self-perception of improvement in hyperhidrosis after six weeks of treatment and on last visit (whenever this occur, as long as this happens after six months), (3) side effects related to drug use.

Eligibility criteria:
inclusion criteria: * primary hyperhidrosis * at least 180 days of treatment with oxybutynin exclusion criteria: * incomplete medical chart * patients with glaucoma

Keywords: treatment efficacy long-term effects tachyphylaxis undesirable effects side effects self-assessment hyperhidrosis quality of life
study evaluating gap-486 in non-sustained ventricular tachycardia

Conditions: Arrhythmias

Summary: to determine whether the administration of test article will decrease the occurrence of ventricular arrhythmias in patients who have acute coronary syndrome (unstable angina, st segment elevated myocardial infarction or myocardial infarction without st elevation).


Eligibility criteria:
inclusion criteria: * male and female patients, 18 years of age or older, that have experienced an acute ischemic event within 24 hours prior to study entry. * patients with a documented history of coronary artery disease or left ventricular dysfunction * patients who have experienced an episode of non-sustained ventricular tachycardia within 24 hours of the index ischemic event exclusion criteria: * patients who have had percutaneous coronary intervention (pci), thrombolytics, or open-heart surgery within 48 hours prior to study entry, or who require it during test article administration * patients who have taken another antiarrhythmic medication (other than a beta blocker) within 5 half-lives of the start of test article * patients who have a history of torsades de pointes, long qt syndrome, qtc \> 0.50

Keywords: arrhythmias
ave0005 (vegf trap) in patients with recurrent symptomatic malignant ascites

Conditions: Ovarian Neoplasms

Summary: the primary objective of this study was to compare the time between paracenteses before and after administration of aflibercept (ziv-aflibercept, ave0005, vegf trap, zaltrap®) in ovarian cancer participants with symptomatic malignant ascites. the secondary objectives were to further assess efficacy and safety of aflibercept treatment, and the exploratory objectives were to assess pharmacokinetics, immunogenicity and health-related quality of life.

the study consisted of: * a 30-day screening phase prior to day 1 * day 1 registration and pre-treatment paracentesis * aflibercept administration within 1-day of registration * two-week study treatment cycles (for efficacy data, the cut-off date was 6 months post-registration * a 60-day post-treatment follow-up phase during the study, participants were treated with aflibercept study treatment through the duration of the study unless they met one the following criteria for discontinuation: * participant (or legal representative) chose to withdraw from treatment * the investigator or sponsor thought that continuation of the study would be detrimental to the participants well-being * participant had intercurrent illness that prevented further administration of investigational product (ip) * participant had more than 2 ip dose reductions * participant had unacceptable adverse events (aes) * participant had arterial thromboembolic events, including cerebrovascular accidents, myocardial infarctions, transient ischemic attacks, new onset angina, or worsening of preexisting angina * participant required surgical intervention for intestinal obstruction or gastrointestinal perforation

Eligibility criteria:
participants that met the following criteria were eligible. inclusion criteria: * symptomatic malignant ascites resulting from advanced ovarian epithelial cancer (including fallopian tube and primary peritoneal adenocarcinoma) that required at least 3 previous therapeutic paracenteses at a frequency of 1 to 4 paracenteses per month for management. * platinum resistant disease defined by relapse or progression of disease during or after treatment, or drug intolerance. * topotecan- and/or liposomal doxorubicin-resistant disease defined by relapse or progression of disease during or after treatment, or drug intolerance. exclusion criteria: * peritoneovenous or other type of shunt that was placed for the management of ascites * prior treatment with a vegf or vegf receptor inhibitor * uncontrolled hypertension the above information is not intended to contain all considerations relevant to participation in a clinical trial.

Keywords: ovarian cancer malignant ascites angiogenesis angiogenesis inhibition vegf-trap fusion recombinant protein
haemodynamic response to aortic surgery

Conditions: Aortic Aneurysm, Abdominal; Aortic Diseases; Acute Kidney Injury

Summary: open elective abdominal aortic surgery is a high risk procedure involving clamping of the aorta. indications include abdominal aortic aneurysm (aaa) or aortic occlusive disease (aod) causing lower limb ischaemia. these patients are often regarded as one entity in postoperative study settings. however, previous studies indicate that risk profiles, inflammatory activity, and haemodynamic capacity may differ between these groups. the first aim of this study was to evaluate postoperative icu-requirements after open elective abdominal aortic surgery, hypothesising that aaa-patients had longer icu-stays and needed more mechanical ventilation or acute dialysis than did patients with aod. the investigators see a relatively high incidence of postoperative acute kidney injury (aki) following aortic surgery. neutrophil gelatinase associated lipocalcin (ngal) may be useful in the early diagnosis of postopeative aki. however, ngal is also known as a marker of inflammatory activation. the ischaemia-reperfusion injury and subsequent inflammatory response to aortic cross clamping may per se induce a rise in ngal despite intact renal function. therefore ngal may not be a reliable marker of aki after aas. the second aim of this study is to describe the changes in ngal after aas in patients with and without postoperative dialysis-dependent aki.


Eligibility criteria:
inclusion criteria: * ct verified aortic aneurysm or aortic occlusive disease exclusion criteria: * age\<18 y * contraindications to the use of oesophagus doppler monitor, eg mycosis, perforation, stenosis.
mitomycin c and ifosfamide in treating patients with metastatic pancreatic cancer

Conditions: Pancreatic Cancer

Summary: rationale: drugs used in chemotherapy, such as mitomycin c and ifosfamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. giving more than one drug (combination chemotherapy) may kill more tumor cells. purpose: this phase ii trial is studying how well giving mitomycin c together with ifosfamide works in treating patients with metastatic pancreatic cancer.

objectives: * to assess the therapeutic activity of a mitomycin c and ifosfamide combination, in terms of progression-free survival rate at 6 months, in patients with metastatic stage iv adenocarcinoma of the pancreas. outline: patients receive mitomycin c iv on day 1 and ifosfamide iv on days 1-3. courses repeat every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed adenocarcinoma of the pancreas * stage iv disease * metastatic disease * prior treatment with gemcitabine-based chemotherapy, also in the adjuvant setting, with progression-free survival at ≤ 12 months * measurable disease according recist criteria * no symptomatic brain metastases patient characteristics: * karnofsky performance status 60-100% (80-100% in patients \> 70 years of age) * adequate bone marrow, liver, and kidney function * not pregnant or nursing * no other prior or concurrent malignancies except surgically cured carcinoma in situ of the cervix, basal cell or squamous cell carcinoma of the skin, or other neoplasms with no evidence of disease ≥ 5 years * no severe comorbidities that could compromise safety, including any of the following: * cardiac failure * cardiac arrhythmia * prior myocardial infarction within the past 4 months * history of psychiatric disabilities prior concurrent therapy: * see disease characteristics * no prior mitomycin c and ifosfamide * no concurrent treatment with experimental drugs

Keywords: acinar cell adenocarcinoma of the pancreas duct cell adenocarcinoma of the pancreas stage iv pancreatic cancer recurrent pancreatic cancer
a study of time restricted eating in obese adults

Conditions: Overweight

Summary: the purpose of this pilot study is to understand the difference between early and late time-restricted eating on weight and body mass index (bmi), and evaluate the barriers encountered and the effect on quality of life.


Eligibility criteria:
inclusion criteria: * ability to read and understand english * bmi ≥ to 25. exclusion criteria: * regularly skip meals. * are unwilling or unable to limit eating to an 8-hour window. * have a current melanoma or cancer diagnosis. * currently breastfeeding. * pregnant, or planned to be pregnant within 3 months. * are taking insulin or sulfonylurea drugs. * are taking weight loss medications or had weight loss surgery within the last year. * have a history of eating disorders.

Keywords: body mass index (bmi) ≥ 25 kg/m^2 early and late time-restricted eating
management of perioperative coagulopathy with thromboelastometry (rotem) in liver transplant

Conditions: Blood Coagulation Disorders; Evidence of Liver Transplantation; Liver Cirrhosis

Summary: a point-of-care bleeding management protocol based on global viscoelastic test (thromboelastometry) can change the amount of blood products used during orthotopic liver transplant.

patients with liver disease frequently acquire a complex disorder of hemostasis secondary to their disease. the fundamental key to the management of coagulopathy of cirrhotic patient is the knowledge that hepatic dysfunction results in impairment of both pro-hemostatic factors as anti-hemostatic factors in a disproportionate manner which can lead to a clinical picture of both bleeding and thrombosis. routine tests of coagulation as prothrombin time (pt, inr) and activated partial thromboplastin time (aptt) although prolonged in cirrhotic patients cannot predict bleeding. global viscoelastic test of whole blood (teg / rotem) produce a dynamic composite image of the entire coagulation process and have the potential to provide clinically relevant information in patients with liver disease allowing rational use of blood products during liver transplantation.

Eligibility criteria:
inclusion criteria: * all patients from the national list of liver transplant assigned to have their transplant in hospital israelita albert einstein who gave free and clarified consent term. exclusion criteria: * acute liver failure * age under 18 * combined transplant * re transplantation less than 30 days * incomplete medical records, more than 20% of missing data.

Keywords: point of care perioperative hemostasis thromboelastometry bleeding risk end-stage liver disease hepatic coagulopathy whole blood coagulation
effects of exercise and insole on foot posture, plantar force distribution, and balance in individuals with pes planus

Conditions: Pes Planus

Summary: the aim is to compare the effects of intrinsic foot muscles and tibialis posterior strengthening exercise, and customized arch support insoles on foot posture, plantar force distribution, and balance in individuals with flexible pes planus.

the aim is to compare the effects of intrinsic foot muscles and tibialis posterior strengthening exercise, and customized arch support insoles on foot posture, plantar force distribution, and balance in individuals with flexible pes planus. forty-two individuals with flexible pes planus will be recruited into the study according to the inclusion criteria. participants will be randomly divided into three groups: (1) exercise, (2) insole, (3) exercise plus insole. exercises will be performed three times per week for six weeks, also custom-made insoles will be worn for six weeks. foot posture will be assessed using the navicular drop, valgus index and foot posture index-6. plantar force variables will be recorded by the pressure-sensitive mat (hr mat, tekscan, usa) mounted in the middle of the 6-meter walkway in three sessions: (1) upright standing, (2) walking at different speeds: self-selected slow, normal and fast speeds, (3) walking just after the heel-rise test for endurance. balance performance will be assessed by the balance master system (neurocom® international inc., usa). the assessments will be made pre/post intervention and at 6-weeks follow-up.

Eligibility criteria:
inclusion criteria: 1. being between 18 and 40 years of age, 2. having navicular drop test greater than 10 mm, 3. having foot posture index-6 greater than or equal to 6, 4. having bilateral flexible pes planus. exclusion criteria: 1. a lack of anatomical integrity of the foot, 2. a history of surgery or trauma in the foot region, 3. other musculoskeletal or neurological problems which may affect balance and gait performance. 4. having received any treatment for lower extremity disorders including pes planus within the last 1 year 5. having a body mass index equal to or greater than 30.

Keywords: pes planus foot posture plantar pressure variables balance short foot exercises tibials posterior strengthening intrinsic foot muscles custom-made insole arch support insole