Kornimate/medical-research-clean huggingface dataset:
imrt followed by cyberknife boost focused on the gross residual pelvic tumor volume

Conditions: Pelvis Tumors

Summary: the present register has been designed to confirm the hypothesis that while using high quality intensity modulated radiation techniques (imrt) and a reduced external beam stereotactic boost component it would be possible to maintain the late severe toxicity rates under the 5 % level in situations where brachytherapy could not be proposed as a boost.

this register concerned patients with any kind of non-resected pelvic cancer for which a brachytherapy gross tumor volume (gtv) boost is non indicated. 1. placement of fiducials first of all, fiducials will be placed near or inside the gross tumor volume (gtv). 2. radiation treatment the radiation treatment will be delivered by varian rapid arc accelerators. 50 gy will be delivered in the planning tumor volume (ptv) 1 and 60 gy in the ptv 2 simultaneously in 28 fractions (5 fractions a week) in no more than 40 days. anytime, 95% of the prescribed dose will have to cover at least 90% of the ptv 1 and ptv 2. 3. ck boost pelvis in the following 14 days after the external beam treatment, two high cyberknife dose sessions will deliver a pelvic boost of 6.5 gy each to the initial gtv or eventually to the residual gtv in case of too close vicinity of the organs at risk (oar). this boost will be planned according to a recent paper, using a new ct scan and mri scan for planimetric purposes. 95% of the prescribed dose will have to cover at least 90% of the ptv. the maximal cyberknife tolerated doses to the oar for a 6.5 gy dose will be 5 gy to 2cc of the bladder, rectum or sigmoid structures and 2.5 gy to 5 cc of the small bowel. the protocol will not require a dose summation of the different steps of the treatment. the total duration of the whole treatment will have to be inferior to 55 days. 4 follow-up the clinical follow up will be planed weekly during the radiation treatments, and at 2, 4 and 6 months thereafter. the patients will be then followed up every 4 months during the first 2 years and twice yearly thereafter. a medical imaging using pet scanner and mri when possible will be performed at least at 6 months intervals during the first 2 years.

Eligibility criteria:
inclusion criteria: * any kind of locally advanced pelvic tumor, non-operable for any reason * signed informed consent * concomitant chemotherapy or hormonotherapy unless gemcitabine will not be contraindicated during the treatment exclusion criteria: * possibility to easily offer the patient a brachytherapy boost * extra pelvic tumor dissemination above the l3 vertebra * collagenoses * any bowel tumor when the digestive tract is not definitely and locally bypassed * any biologic targeted therapy or anti angiogenic therapy within the 6 weeks preceding the initiation of the radiation treatment, for the first 20 patients. this point will be revisited afterwards and will conduct to an amendment in case of protocol modification * gemcitabine chemotherapy within the 6 weeks preceding the initiation of the radiation treatment or during the treatment * hip prostheses
the acute effect of dynamic taping on upper body posture.

Conditions: Dynamic Tape; Postural; Defect

Summary: the aim of this study was to evaluate the acute effect of dynamic tape on cervical and thoracic region posture in asymptomatic male individuals.

fifty-one asymptomatic individuals between the ages of 18 and 32 years were included in the study. the participants in this study were randomised into two groups, named "dynamic taping" (mean age± sd: 23.28±3.41 yrs, n=25) and "sham taping" (mean age± sd: 25.15±4.13 yrs, n=26). in the dynamic taping group, tapes were applied with optimal stretching, while in the sham taping group, tapes were applied without any stretch. all measurements were done before taping and 30 minutes after taping. craniovertebral, cranio-horizontal and sagittal shoulder angles were calculated with photographic posture analysis, while thoracic kyphosis was evaluated with a digital inclinometer (jtech iq pro™, abd).

Eligibility criteria:
inclusion criteria: * between the ages of 18-40 years, * male gender, * not having any injuries to the neck and back region in the last 3 months exclusion criteria: * individuals who were allergic to taping, * had neurological or rheumatological disorders * felt discomfort after starting the study
the efficacy of primary total mesorectal excision (tme) surgery versus neoadjuvant chemotherapy combined with tme surgery in low-risk locally advanced rectal cancer

Conditions: Rectal Cancer

Summary: comparative analysis of the clinical efficacy between primary total mesorectal excision (tme) surgery and neoadjuvant chemotherapy combined with tme surgery for low-risk locally advanced rectal cancer. randomly enrolling eligible patients into either the control group receiving neoadjuvant chemotherapy combined with tme surgery or the experimental group receiving primary tme surgery, and subsequently comparing the clinical outcomes of the two groups


Eligibility criteria:
inclusion criteria: 1. newly diagnosed patients, aged 18 to 75 years; 2. pathologically confirmed rectal adenocarcinoma; 3. distance of the lower margin of the rectal tumor lesion from the anal margin \<15cm; 4. high-resolution mri indicates low-risk locally advanced rectal cancer: t1-3bn1-2 or t3an0 or t3bn0; no involvement of the anal sphincter; negative mesorectal fascia (mrf) status; negative extramural vascular invasion (emvi); no cancer nodules; 5. exclusion of patients with non-local recurrence or distant metastases; 6. absence of synchronous colorectal multiple primary cancers; 7. adequate physical condition to tolerate surgery and neoadjuvant chemotherapy, including cardiac, pulmonary, hepatic, and renal functions; 8. the study physician assessed no difficulty in sphincter preservation; 9. patients and their families will be willing to participate in this study and provide written informed consent. exclusion criteria: 1. patients with concurrent other malignancies or a history of malignant tumors in the past; 2. patients with intestinal obstruction, intestinal perforation, intestinal bleeding, or other conditions requiring emergency surgery; 3. patients with tumor invasion into the external sphincter or levator ani muscles, or involvement of adjacent organs necessitating combined organ resection; 4. patients with poor anal function or fecal incontinence before surgery; 5. patients with a history of inflammatory bowel disease or familial adenomatous polyposis; 6. patients recently diagnosed with other malignancies; 7. patients with asa grade ≥ iv and/or ecog performance status score \> 2; 8. patients with severe liver or kidney dysfunction, significant cardiopulmonary impairment, coagulation disorders, or those with extreme underlying conditions unable to tolerate surgery; 9. patients with a history of severe mental illness; 10. pregnant or lactating women; 11. patients with uncontrolled infections before surgery; 12. patients with other clinical or laboratory conditions, as determined by the investigator, that render them unsuitable for participation in this trial.

Keywords: rectal cancer total mesorectal excision neoadjuvant chemotherapy
compare the quality of life between patients with conduit diversions or orthotopic neobladders

Conditions: Bladder Cancer

Summary: the aim of this study is to compare the health-related quality of life (hrqol) between patients underwent conduit diversion and orthotopic neobladder after radical cystectomy. the investigators plan to use validated hrqol questionnaires to learn about how the different urinary diversion operations affect the hrqol of people living with bladder cancer. the findings from this study may help doctors and patients choosing the proper operation type.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of muscle invasive bladder cancer * must be scheduled for radical cystectomy and subsequent conduit diversion or orthotopic neobladder * must be able to provide informed consent * must be 18 years of age or older * may have had received intravesical neoadjuvant, adjuvant chemotherapy or immunotherapy exclusion criteria: * follow-up data not obtained at wuhan union hospital

Keywords: bladder cancer conduit diversion orthotopic neobladder health-related quality of life validated questionnaire
smartphone addiction in relation to trunk position sense, fatigue and insomnia in adolescences

Conditions: Adolescent Behavior; Smartphone Addiction

Summary: the aim of the study is to evaluate the relationship between smartphone addiction and trunk position sense, insomnia and fatigue in adolescents. sample size will be determined after a pilot study conducted on a small sample of adolescents. digital goniometer will be used to evaluate trunk position sense, insomnia severity index will be used to evaluate insomnia severity and fatigue will be measured by fatigue severity scale.


Eligibility criteria:
inclusion criteria: * adolescents with age between 17 and 18 years old. * bmi between 16.4 and 24.8 kg/m2 * smartphone addiction scale (short version) higher than 33 * smartphone users of 4-5 inches screen size smartphones, weighing 140-160 grams and dimensions less than 159\*79\*9 mm. exclusion criteria: * visual or hearing defects. * congenital abnormalities. * neurological abnormalities * musculoskeletal abnormalities
evaluation of the persistence of the complete molecular remission after stopping imatinib chronic myeloid leukemia

Conditions: Myeloid Leukemia, Chronic

Summary: the first purpose of this study is to evaluate the persistence of the complete molecular remission in patients with chronic myeloid leukemia after stopping imatinib treatment (determine by reverse transcription real-time polymerase chain reaction (rt-pcr) negative for bcr-abl transcripts). the second purpose is to determine clinicals and biologicals factors associated with the persistent complete molecular remission.

principal objective : to evaluate the complete molecular remission persistence after stopping imatinib during six months as measured by rt-pcr negative for bcr-abl transcripts in patients with chronic myeloid leukemia . secondary objective : * to determine clinicals factors associated with complete molecular remission before and after stopping imatinib in patients with chronic myeloid leukemia. * to determine the biologics factors (immunologic and molecular) associated with complete molecular remission before and after stopping imatinib in patients with chronic myeloid leukaemia. * to determine the molecular relapse level after more than six month of persistent complete molecular remission without imatinib. * to determine the complete molecular remission length. * to evaluate medical and economical impact of stopping imatinib treatment. study design : multicentric trial

Eligibility criteria:
inclusion criteria: * patients must have reached their 18th birthday * women of childbearing potential must agree to use effective methods of contraception * patients must be affiliated to a social security regime * patients must have received imatinib therapy for at least 36 months. * patients must be in complete molecular remission during at least two consecutive years with at least five rt-pcr negative measures for bcr-abl transcripts. * patients must be hiv, hcv and hbv negatives * patients who have molecular follow-up realized in accordance with international recommendations * all patients must be informed of the investigational nature of this study and must sign and give written informed consent. exclusion criteria: * patients who are protected by the law. patients who are unable to give their consent to participate to the study. * patients who have pathologies or treatments that are able to enhance the potential relapse risk after stopping imatinib. patients who have pathologies or treatments which able to interfere with immunologic study (excepted ifn α): corticosteroids or other immuno suppressors other concomitant malign pathology treated by chemotherapy or radiotherapy previous or programmed haematopoietic stem cell allogreffe

Keywords: leukemia adult chronic myeloid
detection and characteristic of whipple diseases in the great britany

Conditions: Whipple Disease

Summary: whipple's disease is a chronic systemic infection caused by ubiquitous bacterium tropheryma wipplei on a genetic predisposition which should be considered in patients with recurrent episodes of seronegative arthritis, erosive or not, or inflammatory low back pain, chronic diarrhea, persistent fever, unexplained neurological signs, uveitis, endocarditis, and epithelioid granuloma. laboratory tests may show malabsorption, erythrocyte sedimentation rate and c-reactive protein elevation, anemia, thrombocytosis, eosinophilia and lymphopenia. none of theses findings is specific and most patients have arthritis or low back pain mimicking rheumatoid arthritis and spondyloarthritis. as the disease is rare, chance for positive polymerase chain reaction testing for tropheryma whipplei is low in this context.


Eligibility criteria:
inclusion criteria: * adult * patient with at least a screening test for whipple'disease * participation agreement, exclusion criteria: * no test for whipple'disease
clinical evaluation of lifescan blood glucose monitoring systems

Conditions: Diabetes Mellitus

Summary: study to determine the performance of the lifescan bgms when conducted at mac clinical site.

this study will evaluate the performance of the mac clinical site to evaluate accuracy performance of lifescan blood glucose monitoring systems as it is conducted at other lifescan uk affiliated clinic sites. multiple lifescan blood glucose monitoring system (bgms) will be tested with production lots which have passed release testing.

Eligibility criteria:
inclusion criteria: * participants must be enrolled in lifescan patient registry. * participants must have read the information sheet and signed an informedconsent form \>prior to study participation. * participants must be 16 years or older. * participants must be diagnosed with diabetes exclusion criteria: \> participants not enrolled in the lifescan patient registry
early aggressive versus initially conservative therapy in elderly patients with non-st-elevation acute coronary syndrome

Conditions: Acute Coronary Syndrome

Summary: a randomized study comparing an early aggressive with an initially conservative strategy in patients \>74 y.o. with non-st-elevation acute coronary syndrome. this study had generated a secondary one: "causes of death in elderly patients with non-st-elevation acute coronary syndrome; predictors of in-hospital and follow-up death"

patients \>74 y.o. with non-st-elevation acute coronary syndrome will be randomised to an early aggressive (coronary angiography within 72 hours followed, when indicated, by revascularization) or an initially conservative strategy (medical therapy, and coronary angiography only for refractory ischemia). as reported in amendment 1, the trial was stopped in may 2010 after the enrolment of 313 patients, which was the minimum sample size calculated in order to achieve a 80% power of detecting a difference in the primary-endpoint rate from 40% in the conservative arm to 25% in the invasive arm, based upon the log-rank test for survival curves (1-beta 0.80; 2-tailed alpha 0.05)

Eligibility criteria:
inclusion criteria: * over 74 years of age. * have had symptoms suggestive of acute myocardial ischemia at rest within 48 hours prior to randomization, and ischemic ecg changes or elevated levels of biochemical markers of myocardial damage. * provide written informed consent before randomization. exclusion criteria: * secondary causes of acute myocardial ischemia. * ongoing myocardial ischemia despite maximally titrated anti-ischemic therapy (invasive strategy recommended). * ongoing signs of acute heart failure despite treatment (invasive strategy recommended). * percutaneous coronary intervention or bypass surgery within 30 days prior to randomization. * a serum creatinine level greater than 2.5 mg/dl. * active internal bleeding, history of hemorrhagic diathesis or recent transfusion of red blood cells, whole blood or platelets. * history of cerebrovascular accident within the previous month. * known current platelet count \< 90,000 cells/ml. * gastrointestinal or genitourinary bleeding of clinical significance within 6 weeks prior to randomization. * concomitant severe obstructive lung disease, malignancy or neurologic deficit limiting follow-up or adherence to the study protocol. * participation in any phase of another clinical research study involving the evaluation of another investigational drug or device within 30 days prior to randomization. * inability to give at least verbal informed consent to the study.

Keywords: coronary artery disease coronary angioplasty coronary artery bypass surgery elderly
impact of the eurékoi serious game on family caregivers of patients with a major neurocognitive disorder

Conditions: Family Caregiver of Patient With Alzheimer Disease

Summary: this study aims to assess the effectiveness of serious eurekoi gambling on the anxiety of family caregivers of patients with newly diagnosed alzheimer's disease.


Eligibility criteria:
inclusion criteria: * men or women over 18 years old; * primary caregiver of a patient with a mild-stage major neurocognitive disorder newly diagnosed according to the dsm 5 criteria; * signature of informed consent. exclusion criteria: * subject not speaking french, not reading french * subject with visual impairment * subject under tutorship or curatorship.
study of irnea (irinotecan, etoposide, cytarabine) for refractory or relapsed acute leukemia in children and adolescents

Conditions: Acute Leukemia

Summary: the purpose of this study is to determine the maximum tolerable dose of irinotecan in combination with etoposide, cytarabine for refractory or relapsed acute leukemia in pediatric patient.


Eligibility criteria:
inclusion criteria: * diagnosis of all or aml. * prior therapy patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study. * all patients must have had two or more prior therapeutic attempts defined as * persistent (bm blast\>5%) initial disease after two induction attempts, or * persistent (bm blast\>5%) after re-induction attempt for first relapse or * relapse after one re-induction attempt (2nd relapse) * aml patients must have one or more prior therapeutic attempts defined as * refractory (bm blast\>20%) initial disease after one induction attempts, or * persistent (bm blast\>5%) initial disease after two induction attempts, or * relapse after one induction attempt (1st relapse) * relapse after stem cell transplant: patients are eligible 12 weeks after allogeneic stem cell transplant as long as patients are not actively being treated for gvhd and have recovered from transplant-related toxicities. patients are eligible 8 weeks from the day of stem cell infusion for myeloablative autologous stem cell transplant, if hematological and all other eligibility criteria are met. * age: ≤ 21 years. * performance status: ecog 0-2. * patients must be free of significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases. 1. heart: a shortening fraction ≥ 28% 2. liver: total bilirubin \< 2 × upper limit of normal; alt \< 3 × upper limit of normal. 3. kidney: creatinine \ 60 ml/min/1.73m2. * patients must lack any active viral infections or active fungal infection. * patients (or one of parents if patients age \< 19) should sign informed exclusion criteria: 1. pregnant or nursing women. 2. malignant (except acute leukemia) or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy. 3. psychiatric disorder that would preclude compliance. 4. patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.

Keywords: pediatric refractory or relapsed acute leukemia
improved muscle function in duchenne muscular dystrophy through l-arginine and metformin

Conditions: Duchenne Muscular Dystrophy

Summary: the purpose of the study is to show that the intake of l-arginine and metformin improves muscle function and delays disease progression in patients with duchenne's muscular dystrophy.

this is an investigator-initiated, open-label, single-center, proof-of-concept-study. the study medication consists of l-arginine and metformin. the duration of the study is 16 weeks and comprehends one screening and four study visits.

Eligibility criteria:
inclusion criteria: * molecular diagnosis of dmd * patients 7 - 10 years of age at time of screening * ambulant exclusion criteria: * previous (3 months or less) or concomitant participation in another therapeutic trial * use of l-arginine, l-citrulline or metformin within the last 3 months * known individual hypersensitivity to l-citrulline or metformin * other chronic disease or clinical relevant limitation of renal, liver, heart function according to discretion of the investigator
a study to test if tev-48574 is effective in relieving asthma

Conditions: Asthma

Summary: the primary objective of the study is to evaluate the effect of tev-48574 compared with placebo on loss of asthma control (loac) in adult participants with t2-low and non-t2 severe asthma uncontrolled on inhaled corticosteroids plus long-acting beta-agonists (ics+laba). the secondary efficacy objective is to evaluate the effect of tev-48574 compared with placebo on a range of clinical measures of asthma control. the duration of participant participation in the study is planned to be up to approximately 30 weeks.


Eligibility criteria:
inclusion criteria: * the participant has a diagnosis of asthma for at least 12 months prior to the initial screening visit. * the participant is able to perform technically acceptable and repeatable spirometry, including with a hand-held spirometer, after training * the participant has had at least one documented clinical asthma exacerbation in the 18 months prior to (but not within 30 days of) the initial screening visit. * the participant is a non-smoker for ≥6 months with lifetime history ≤10 pack-years, with no current ecigarette or marijuana use. note- additional criteria apply, please contact the investigator for more information exclusion criteria: * the participant has any concomitant conditions or treatments that could interfere with study conduct. * the participant is currently pregnant or lactating or is planning to become pregnant during the study. * the participant has received any live or attenuated vaccine within 15 days of the initial screening visit. note- additional criteria apply, please contact the investigator for more information

Keywords: t2 low, non-t2 asthma