Kornimate/medical-research-clean huggingface dataset:
effect of apa on sleep quality in children with cancer from 5 to 16 years

Conditions: Child, Only; Blood Cancer; Adapted Physical Activity; Sleep

Summary: main objective : evaluate the effect of adapted physical activity on the sleep of children with cancer from 5 to 16 hypothesis : practice daily adapted physical activity improve the sleep of the 5 to 16 children with cancer

medical process are leading to an increase in the survival of children/adolescents undergoing treatment for blood cancer. caregivers need to focus on optimizing these patients' quality of life during and after the disease. sleep is essential to their development. sleep disorders are symptoms reported by patients. they have a negative impact on their quality of life. adapted physical activity sessions are offered in pediatric oncology departments, but sedentary behavior persists. the hypothesis is that the daily practice of adapted physical activity will improve sleep in patients treated for blood cancer. this is a randomized, cross-over, open-label, two-armed parallel, unique center therapeutic trial comparing the effect of practice adapted physical activity only once during four days (conventional strategy) versus practice adapted physical activity each day during four days (experimental strategy) on the sleep of the children with blood cancer from 5 to 16 at the hospital in clermont-ferrand and at home. the study will last four weeks with a wash-out week after 2 weeks. the outcomes are described later. the nurse informs and obtains the consent of the child and his parents. after statistical analysis of these two arms, it will be possible to determine the value of practice daily adapted physical activity on the sleep of children with blood cancer from 5 to 16 at the hospital and at home.

Eligibility criteria:
inclusion criteria: * children from 5 to 16 with haematological cancer undergoing treatment * subjects and their parents who were informed about the study and gave informed consent. * enrollment in the social security system exclusion criteria: * children on high-dose corticosteroids * children under anxiolytic treatment * children with sleep disorders (sleep apnea) * children taking melatonin or sleeping pills * contraindication to adapted physical activity * refusal to participate on the part of the participant or his/her parents * holders of parental authority under curatorship, guardianship, safeguard of justice * pregnant or breast-feeding teenagers

Keywords: child blood cancer adapted physical activity sleep hospital and home
comparison of externally versus internally cooled tip catheter ablation in paroxysmal atrial fibrillation

Conditions: Atrial Fibrillation

Summary: there is no study comparing safety/efficacy of externally vs internally cooled tip catheters in patients undergoing ablation for paroxysmal atrial fibrillation (paf). the primary objective is to compare safety and efficacy of externally irrigated-tip catheter versus internally irrigated-tip catheter in achieving long term electrical isolation (ei) of pulmonary veins (pv) in paroxysmalatrial fibrillation (paf).

atrial fibrillation is the most common of all sustained cardiac arrhythmias, with the prevalence increasing with age to up to 5 percent in persons more than 65 years of age, to 10 percent in persons more than 80 years of age and it is a major cause of stroke. since its introduction into clinical practice, catheter ablation (ca) aimed at cure of atrial fibrillation (af) has become increasingly prevalent. different techniques have been proposed and are currently under investigation in various electrophysiology (ep) laboratories, with increasing knowledge of the pathophysiology of human af and critical assessment of clinical outcome after the curative procedure. the favorable results reported in different studies have fueled enthusiasm for ca of af, with the number of ablation procedures increasing from 1994 to the present time. however, these technologies have varied catheter designs, ranging from different forms of irrigation (external or internal irrigation). the increase of the rate of success of the af by ablation with the development of new catheters has permitted a considerable reduction of the medical treatment and the disappearance of grave complications. the procedure will be " standard " with isolation of pulmonary veins and block through the cavo-tricuspid isthmus obtained. following completion of the procedure, patients will have anti vitamin k drug therapy for 3 months and antiarrhythmic drug for 1 month in case of early atrial arrhythmia recurrence. two-dimensional echocardiogram will be performed systematically prior to discharge. all 3 months, long-term follow-up consisted from the date of the ablation procedure with consultation, stress test, holter-ecg (24 h) and echocardiography. at 3 months a repeat ep procedure will be performed in patients with af recurrence to assess whether or not lines are still blocked. if not, rf will be delivered to block them again and cure af.

Eligibility criteria:
inclusion criteria: * adults (≥18 years old) * drug refractory paroxysmal af with episods lasting \<24hours * follow-up possible at one of the 2 institutions performing the study * oral agreement of the patient after reading the document of information exclusion criteria: * pregnancy * psychiatric troubles not stabilized * contraindication to undergo af ablation * previous attempt at af ablation * cardioversion for af * no oral agreement of the patient for the study

Keywords: fa atrial fibrillation catheter ablation rf
biocollection of patients with anca associated vasculitis

Conditions: ANCA-associated Vasculitis

Summary: as rare disease, vasculitis affects a small number of patients, the cohorts available in the literature are few and the pathophysiological mechanisms remain to be elucidated. the collection of standardized data within a patientheque as part of a multi-year follow-up will facilitate the study of the characteristics of these diseases. this may, in particular, address the main objective of identifying predictors of relapse, as well as secondary objectives for predictive factors of mortality, infectious, cardiovascular or neoplastic complications that affect the prognosis of vasculitis in order to establish a more appropriate management of the patients concerned.

vasculitis associated with anti-neutrophil cytoplasm antibodies (anca) is a group of rare and severe autoimmune diseases, encompassing several entities: granulomatosis with polyangiitis (gpa), microscopic polyangiitis (pma), and eosinophilic granulomatosis with polyangiitis (gepa). when untreated, these diseases are fatal in a matter of months. currently, thanks to the use of corticosteroids and immunosuppressants, this high mortality has greatly decreased and these are now chronic diseases. on the other hand, these patients are at high risk of morbidity, linked to both relapses (occurring in at least 50% of patients) and side effects of treatments. it is therefore essential to be able to define which patients are at risk of relapse and justify long-term immunosuppressive treatment to avoid recurrence of the disease, and conversely which patients have a low risk of relapse and in whom immunosuppressive treatments can be discontinued to limit the risk of side effects. however, so far no predictor or biomarker can accurately assess this risk of relapse.

Eligibility criteria:
inclusion criteria: * major patients with no upper age limit. * patients assessed as part of the reference centre for rare autoimmune diseases at the chru in brest. * patients for whom a diagnosis of anca-associated vasculitis is made by the physician in charge of the patient, according to the definitions of the chapel-hill consensus conference. * patient affiliated with social security * patient who has signed written informed consent exclusion criteria: * minor * patients unable to consent. * patients refusing to participate in research * patient under legal protection (tutelage, curatorship) * pregnant or lactating women * hemoglobin (hb) \< 7g/dl
improving patient and family centered care in advanced critical illness

Conditions: Anxiety; Depression

Summary: one in five deaths in the u.s. occurs in or shortly after discharge from an intensive care unit (icu), typically following decisions made by surrogate decision makers to forego life prolonging treatment. a large body of empirical research has identified deficiencies in care processes that contribute to three important problems: 1) family members often experience poor quality communication with icu clinicians, leading to lasting psychological distress associated with the icu experience; 2) patients near the end of life frequently receive invasive, expensive treatment that is inconsistent with their values and preferences, and 3) end-of-life care is a major contributor to health care costs.\[8, 9\] although advance care planning can prevent some unwanted treatment, many patients wish for a trial of intensive treatment when the prognosis is uncertain, and therefore it seems likely that the need for interventions to improve "in-the-moment" decisions by surrogates will persist.\[10, 11\] in a pilot project, the investigators developed the partner intervention (pairing re-engineered icu teams with nurse-driven emotional support and relationship-building), an interdisciplinary intervention that 1) gives new responsibilities and advanced communication skills training to existing icu staff (local nurse leaders and social work members of the icu team); 2) changes care "defaults" to ensure frequent clinician-family meetings; and 3) adds protocolized, nurse-administered coaching and emotional support of surrogates before and during clinician-family meetings. the objective of this proposal is to conduct a stepped wedge randomized controlled trial testing the partner intervention in 5 icus among 1000 patients with advanced critical illness and their surrogates.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * surrogate decision maker for icu patient in one of 5 upmc icu's exclusion criteria: * non-english speaking * surrogate's loved one is for organ transplantation * not physically able to participate in family meeting

Keywords: decision making for incapacitated patients intensive care surrogate decision making patient centered care palliative care end of life quality of communication
(cost-)effectiveness interdisciplinary community-based copd management program (intercom)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: there is growing evidence that copd is a multi-organ system disease. besides impaired lung function, skeletal muscle weakness and weight loss are important determinants of impaired exercise performance, decreased quality of life and increased mortality. based on earlier succesful intervention studies in pulmonary rehabilitation settings, máxima medical centre developed an integrated, inter-disciplinary approach to the management of copd including physical exercise, nutritional therapy, education, smoking cessation and psychological consultation. this copd management program consists of a set of protocols that cover patient recruitment, diagnostic testing, treatment, follow-up and communication between professionals. the exercise program and the nutitional therapy are carried out by local physiotherapists and dieticians working outside but in conjunction with the hospital. a program in such a setting could be substantially less expensive and certainly more easily accessible for many more patients than an inpatient or hospital-based outpatient rehabilitation program, as it is offered close to a patient's home. this study investigates the (cost-)effectiveness of the copd management program compared to usual care in a randomized controlled trial. patients with moderate to severe copd and a reduced exercise capacity during an incremental exercise test of less than 70% of predicted, are randomised to a treatment or a control group. the treatment group will participate in the copd management program during the first 4 months after which they will be followed up for the remaining months. both groups (n=100) are followed for 2 years and outcomes will be assessed at the beginning of the program, after 4, 12 and 24 months by disease-specific and generic measures of health status, body composition, skeletal muscle function and exercise capacity. a cost-effectiveness and cost-utility analysis with a two-year time horizon will be performed. the analysis is conducted from a societal perspectice, including the program costs and all copd-related direct costs within and outside the healthcare sector ans costs of lost productivity.


Eligibility criteria:
inclusion criteria: * moderate to severe copd according to the recent gold guidelines * reduced exercise capacity during an incremental exercise test of less than 70% of predicted normal values exclusion criteria: * lack of motivation to participate in the treatment program * other pathologic conditions unabling participation in the training program (e.g. coronary, orthopaedic, neurological or severe endocrine disorders) * participation in other pulmonary rehabilitation projects
the effect of the type of conduit-duct anastomosis technique on the postoperative course in patients undergoing liver transplantation

Conditions: Liver Transplant; Complications; Bile Duct; Stricture, Postoperative; Bile Leak; Quality of Life

Summary: the main objective of the trial is to compare the effect of two end-to-end duct-to-duct anastomosis surgical techniques using the continuous suture method versus interrupted method (control group) on reducing the risk of bile leakages in the 90-day follow-up period after liver transplantation and other postoperative complications resulting from them i.e.: the occurrence of a critical stenosis in the duct-to-duct anastomosis within 90 days. in addition, as part of the research experiment, long-term biliary complications will be assessed, i.e. occurring over a period of more than 90 days (a 2-year observation period of patients was assumed). as part of the trial 284 patients qualified for the procedure of liver transplantation from a deceased donor will be included, in whom end-to-end anastomosis of the bile ducts will be performed. after entering the study, patients will be randomized to one of the groups. in the group of 142 patients, duct-to-duct anastomosis will be performed using an interrupted suture (control group), and the remaining patients will be performed using the continuous suture technique. the analysis will also include surgical complications, complications related to early and late graft function, retransplantation and overall survival. additionally the analyses an analysis of the impact of the occurrence of a biliary complication on the quality of life of patients after liver transplantation will be performed on the basis of the eortc qlq-c30 forms. the period of observation of the patient after the procedure is planned for 24 months.


Eligibility criteria:
inclusion criteria: * age over 18 * elective liver transplantation * informed consent to participate in the study * recipient bile duct diameter over 3mm * donor bile duct diameter over 3mm exclusion criteria: * age below 18 * pregnancy * living donor liver transplantation * split-liver or reduced-size liver transplantation * liver transplantation other than from brain death donor * liver transplantation with hepaticojejunostomy * patients undergoing re-transplantation * multi-organ transplantation * recipient bile duct diameter below 3mm * donor bile duct diameter below 3mm
oral corticotherapy in megadoses to treat multiple sclerosis during relapse

Conditions: Multiple Sclerosis

Summary: this is a phase iv, multicenter, randomized, double blind clinical trial. the investigators will study 48 patients with remitting relapsing multiple sclerosis (ms) experiencing moderate or severe attack receiving immunomodulatory therapy or not. patients will be randomly assigned to one of the two groups.

this is a multicenter, randomized, double blind clinical trial to test whether oral methylprednisolone (mp) is not inferior to intravenous methylprednisolone for the treatment of multiple sclerosis (ms) relapse in terms of clinical and radiological efficacy. patients will be randomly assigned to one of the following two groups. group a: methylprednisolone 1.000 mg/day intravenous administered during three days + placebo of methylprednisolone orally administered group b: methylprednisolone 1.250 mg/day orally administered during three days + placebo of methylprednisolone intravenously administered. clinical visits will be conducted at 7, 28 and 90 days after treatment starting.

Eligibility criteria:
inclusion criteria: 1. to have been diagnosed ms remittent recurrent according to mc donald 20052 criteria. 2. to have an edss between 0 and 5 before the relapse. 3. the symptoms have begun after at least one month of previous stability. 4. the symptoms have started maximum 15 days before the inclusion. 5. the patient is capable of having an adequate communication with the investigator and to carry out with the clinical trial requisites. 6. to be or not to be with allowed immunomodulatory therapy (ifn-b /ag). 7. to be capable and to be willing to ingest the medication. exclusion criteria: 1. first inflammatory neurological episode (relapse). 2. multiple sclerosis secondary progressive or primary progressive. 3. the symptoms have gone on for less than 24 hours. 4. to be in treatment or have been treated with corticoids during the three months before. 5. patients in treatment with immunosuppressors (azathioprine, mitoxantrone, ciclofosfamide...) 6. pregnancy or breastfeeding or women in fertile age who don't use contraceptives measurements. 7. illnesses with contraindication treatment with corticoids. 8. antecedents of serious adverse effects or hypersensitive to related study medication. 9. patients who wouldn´t be able to perform periodic rmn explorations, patients who are not collaborative or who need anesthesia. 10. patients with intolerance to lactose. 11. patients with allergy to contrast used in rmn. 12. patients with chronic kidney disease. 13. patients in treatment with natalizumab.

Keywords: multiple sclerosis relapse methylprednisolone
evidence-based psychological treatment for emotional disorders attended in dominican primary care units (psicap)

Conditions: Anxiety Disorders; Depression; Somatic Disorders; Emotional Disorder

Summary: emotional disorders affect millions of people all over the world. thousands of dominicans suffer from depression, anxiety, and other emotional disorders that have negative impact on their lives. nevertheless, many of them do not receive a proper treatment. the purpose of this study is to describe a pilot project, in which a protocol of evidence-based psychological treatment for emotional disorders, supported by mhealth (mobile health), will be applied on dominicans who attend primary care services. it will be a collaborative program, divided into three phases, and based on cognitive behavioral therapy. the hypothesis of this research is that this protocol is an effective strategy to treat emotional disorders.

emotional disorders, such as anxiety, depression and somatic disorders, represent a serious public health issue. many people who suffer from them do not have access to an adequate psychological treatment. some of the reasons why this situation happens are: the high cost that tends to represent a proper psychological treatment, and, in countries like dominican republic, the lack of a protocol that guides health professionals of primary care units on the diagnosis and treatment of these emotional disorders. the purpose of this study is to describe a pilot project, in which a treatment protocol for emotional disorders will be applied by trained mental health professionals in dominican primary care units. it will be a randomized controlled trial with 300 patients. to prove the effectiveness of this protocol, the phases of this study will be: 1) psychological assessment of the study sample; 2) seven sessions of conventional treatment offered to a control group, and seven sessions of the evidence-based psychological techniques, suggested by this new protocol, given to an experimental group; 3) psychological reassessment of the study sample. this protocol suggests transdiagnostic approaches and collaborative interventions, that include group-sessions and evidence-based psychological techniques derived from cognitive behavioral therapy. also, the protocol will be supported by mhealth tools. some of the points included in the protocol are: psychoeducation on emotional disorders symptoms, relaxation and breathing techniques, thought management, improvement of quality of life and relapse prevention.

Eligibility criteria:
inclusion criteria: * age between 18 and 79 years old. * adults with mild or moderate levels of anxiety, depression or somatic disorders. * dominicans. * people who are not receiving any psychological treatment. * people who know how to read and write. exclusion criteria: * a diagnostic of severe mental/emotional disorder. * recent suicide attempt. * severe disability. * people who do not meet sufficient criteria to be diagnosed with mental or emotional disorders.

Keywords: cognitive behavioral therapy primary care emotional disorders
etoposide-carboplatin alone or with endostar for extensive disease small cell lung cancer (ed-sclc)

Conditions: Small Cell Lung Cancer

Summary: background: the effect of existing treatment modalities of extensive disease small-cell lung cancer (ed-sclc) is unsatisfactory. progress of new strategies including more efficient therapy is wanted. endostar® (rh-endostatin injection) may have anti-tumor activity by against vascular endothelial growth factor for initial treatment. this study was designed to evaluate the safety and efficacy of endostar® combined with etoposide-carboplatin (ec) chemotherapy in patients with ed-sclc seeking for more effective treatment.

methods: in this randomized, open label, placebo-controlled, multicentre trial, 120 patients are planned to be enrolled at random into 2 arms(1:1) from 10 centers between june 2009 and june 2011. the leader units are shanghai chest hospital affiliated to shanghai jiao-tong university. main eligibility criteria are histological or cytological diagnosis of ed-sclc, with an age of 18-75 years. all eligible patients receive etoposide-carboplatin (ec) alone or with endostar® for 4-6 cycles (21 days for 1 cycle). in arm1 patients receive endostar® 7.5mg/m2 on day 1 to day 14, etoposide 60 mg/m2 on day 1 to day 5 and carboplatin auc 5 on day 1. in arm2 patients receive etoposide 60 mg/m2 on day 1 to day 5 and carboplatin auc 5 on day 1. primary endpoint: progress free survival (pfs). secondary endpoint: progress free survival at 6 months, overall survival (os), objective response rate (orr), clinical benefit rate (cbr), response duration, time to progression(ttp) and quality of life (qol).

Eligibility criteria:
inclusion criteria: * histologically or cytologically diagnosed sclc; * age of 18-75 years; * life expectancy \> 3 months; * adequate hematologic, renal, and hepatic function; * ecog ps 0-2; exclusion criteria: * brain metastases; * clinically significant cardiovascular disease; * presence of hepatic and renal dysfunction; * evidence of bleeding diathesis or coagulopathy * pregnant or lactating woman;