Kornimate/medical-research-clean huggingface dataset:
optimisation of decision making for defibrillator implantation in hypertrophic cardiomyopathy

Conditions: Hypertrophic Cardiomyopathy

Summary: the main objective of the study is to improve implantable cardioverter defibrillator (icd) implantation decision-making processing relevance by developing a new prediction model of sudden cardiac death (scd) in hypertrophic cardiomyopathy (hcm), including newly identified potential biomarkers by magnetic resonance imaging (mri) and genetics, through a prospective nationwide study, multivariate analysis and modelling of an absolute risk. the secondary objective is to perform a medico-economic analysis of icd implantation in order to define an optimal rule for icd implantation in patients with hcm, taking into account the benefits of icd, adverse effects of icd and associated costs (cost of quality adjusted life years saved).

hcm is a genetic disease, usually autosomal dominant, with a prevalence of about 1/500 in the general population. hcm represents a major cause of scd in the young, and is the first cause of scd in athletes less than 35 years of age. the only efficient prevention of scd, apart from exercise restriction, is icd. given this dreadful potential outcome of hcm, the identification of patients that should receive an icd is of paramount importance. however, the indications for icd are controversial and very different guidelines are currently available, coming from the american society of cardiology, the french haute autorité de santé and from the european society of cardiology. in addition, these guidelines are all based on retrospective studies and have major limitations. the situation faces a critical need of improvement. thus, this study has been designed with the objective to propose a revision of international recommendations for defibrillator implantation in hcm patients. this prospective multicenter non-interventional single-arm study is planned to be conducted in 40 sites with a collection of clinical and biological data, carried out as required for the usual management and care of patients. no investigation will be performed specifically for this study except for an additional blood sample collection at baseline during routine outpatient care and annual interview during follow-up.

Eligibility criteria:
inclusion criteria: * patient with a diagnosis of hcm based on conventional criteria (left ventricle wall thickness ≥ 15 mm in adult index or ≥ 13 mm in adult relatives) in the absence of abnormal loading conditions * aged ≥ 16 years * patient without or with a defibrillator (in this latter case it should have been implanted for primary prevention, not for secondary prevention) * affiliation to a social security insurance exclusion criteria: * specific etiologies such as amyloidosis * patients with icd as secondary prevention (after aborted scd or sustained ventricular arrhythmia)

Keywords: hypertrophic cardiomyopathy implantable cardioverter defibrillator
study of ezn-2208 pediatric patients with solid tumors

Conditions: Solid Tumors

Summary: the goal of this clinical research study is to find the highest tolerable dose of ezn-2208 that can be given to pediatric patients with relapsed or refractory solid tumors. the safety of the study drug and its effect on the disease will also be studied.

pharmacokinetic (pk) testing of ezn-2208, will be performed for patients who volunteer. pk testing measures the amount of a drug in the body at different time points.

Eligibility criteria:
inclusion criteria: * patients with histologic verification of malignancy at original diagnosis or relapse. * measurable or evaluable disease * karnofsky score more or equal to 50 for patients \>16 years of age and lansky score more or equal to 50 for patients \<16 years of age * patients previously treated with irinotecan will be eligible for this study if they have not had documented progressive disease during treatment with an irinotecan-containing regimen. * adequate hematologic, hepatic, coagulation, renal, and metabolic function exclusion criteria: * pregnant or breast feeding patients will not be enrolled in this study * patients who are currently receiving other anticancer agents * patients who have an uncontrolled infection * patients requiring cytochrome p450 3a4 enzyme inducing or inhibiting agents

Keywords: patients with non-cns or cns tumors pediatric patients with relapsed/refractory solid tumors
e3-hormone refractory prostrate cancer taxotere combination

Conditions: Prostate Cancer; Metastatic; Hormone Refractory

Summary: the purpose of this study is to determine whether treatment with zactima (vandetanib) in combination with docetaxel and prednisolone is more effective than the standard docetaxel and prednisolone alone for prostate cancer, in patients with hormone refractory prostate cancer who have not previously received chemotherapy.


Eligibility criteria:
inclusion criteria: * metastatic hormone refractory prostate cancer defined as those patients with evidence of progression of disease in spite of castrate levels of testosterone indicated by rising levels of psa * no previous chemotherapy although those patients that have received estramustine can enter the study provided the estramustine was stopped 3 weeks before dosing of study drug * screening psa values \>20ng/ml. this must be confirmed by two separate measurements at least 2 weeks apart exclusion criteria: * treatment within 4 weeks before randomization and/or whilst on study, treatment with the following: 1)non-approved or experimental drug, 2)treatment with a drug with similar mechanism of action to zd6474 * concurrent treatment with other anticancer agents, othr than docetaxel and prednisolone as defined in the protocol

Keywords: prostate cancer zactima vandetanib metastatic
a study of oral upadacitinib tablets to assess treatment patterns, achievement of treatment targets and maintenance of response in adult participants with moderate to severe rheumatoid arthritis

Conditions: Rheumatoid Arthritis (RA)

Summary: rheumatoid arthritis (ra) is an inflammatory disease of the joints causing pain, stiffness, swelling and loss of joint function. despite the range of treatment options for ra steadily increasing, many patients remain sub-optimally managed, with sustained clinical remission rarely achieved. this study will assess the treatment patterns, achievement of treatment targets and maintenance of response. upadacitinib is a drug approved for the treatment of moderately to severely active rheumatoid arthritis. adult participants with moderate to severe ra who have been prescribed upadacitinib by their physicians will be enrolled. approximately, 1660 participants will be enrolled this study, worldwide. participants will not receive upadacitinib as part of this study, but will be followed for response to treatment for up to 24 months. there may be higher burden for participants in this trial compared to their standard of care. participants will attend regular visits, every 3 months, during the course of the study at a hospital or clinic and will be asked to provide additional information by questionnaire at each visit.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of moderate to severe active rheumatoid arthritis (ra). * physician decision on patient treatment with upadacitinib must have been reached prior to and independently of recruitment in the study. * upadacitinib prescribed in accordance to the applicable approved label and local regulatory and reimbursement policies. * french participants only: taking oral glucocorticoids ≥5 mg/day of prednisone or equivalent for at least 3 months prior to study start. exclusion criteria: - prior treatment with upadacitinib.

Keywords: rheumatoid arthritis upadacitinib rinvoq
impact of gel aromatherapy on pain for patients with de quervain disease

Conditions: De Quervain Disease

Summary: de quervain disease is characterized by an adductor pollicis longus and extensor pollicis brevis tendons inflammation as thys pass beneath the extensor retinaculum at the radial styloid. this pathology is recognized as a musculoskeletal disorder of the upper limb triggering functional deficits resulting to possible modifications in the professional activity, sources of absenteeism, thus constituting an economic cost for society. at the etiological level, this pathology also affects young mothers (it's called "mother's wrist" or mommy thumb"), mobile phone users ("textonite", "blackberryte") or video game players ("nintendoite"). currently, the treatment is mainly conservative by splint and anti-inflammatory gel and/or corticosteroid infiltration. howewer, these therapies have undesirable effects. the interest of this study is therefore to propose another therapy based on aromatherapy gel.


Eligibility criteria:
inclusion criteria: * male or female patient aged 18 to 75, * patient with unilateral de quervain's tenosynovitis, * patient cared in the hand surgery department, sos mains emergency department or rheumatology department of strasbourg university hospitals, * patient informed of the results of the prior medical examination, * informed consent signed by the patient, * patient affiliated to a health insurance social protection scheme or beneficiary, * for a woman of childbearing potential, negative urine pregnancy test at the inclusion visit and maintenance of effective contraception throughout the study. exclusion criteria: * pregnant or breastfeeding patient, * patient allergic to a component of the gel with essential oils, dicloflenac®, nsaids, or one of the excipients * patient treated with oral non-steroidal anti-inflammatory drugs * patient with ongoing treatment with another ointment at the treatment application site (radial edge of the wrist) * patient with damaged skin, whatever the lesion: oozing dermatosis, eczema, infected lesion, burn or wound, * patient with atopic skin disease, * patient with epilepsy or with a history of epilepsy, * patient with a history of homolateral de quervain's tenosynovitis, or having already had corticosteroid infiltrations in the 6 months before his inclusion on the ipsilateral side of the pathology, * patient with associated tendinopathies in the elbow or forearm region, * impossibility of giving the patient information (patient in an emergency situation, patient with difficulties of understandin, agitation of the patient), * patient under legal protection, under guardianship or curatorship.
clinical echocardiography and s' wave for early recognition of acute coronary syndrome in the emergency department, a prospective study

Conditions: Acute Coronary Syndrome; Myocardial Infarction (MI); Non-ST Elevation Myocardial Infarction; Unstable Angina; Echocardiography; Tissue Doppler; Emergency Medicine; Cardiac Function Tests

Summary: the goal of this prospective observational study is to assess the diagnostic accuracy of the tissue doppler imaging (tdi) s' wave in detecting acute coronary syndrome (acs) in adult patients presenting to the emergency department (ed) with acute chest pain. this study focuses on patients aged 18 years or older, who require continuous cardiac monitoring but do not show st-elevation myocardial infarction (stemi) on their initial ecg. the main questions it aims to answer are: * can tdi s' wave velocity serve as an early diagnostic marker for acs in the emergency department? * how does the diagnostic performance of tdi s' compare with other echocardiographic markers (mapse, tapse, and diastolic parameters such as e, e', a, e/a, e/e')? * do demographic factors (age, sex, bmi, echogenicity) influence the diagnostic accuracy of echocardiographic parameters for acs? if there is a comparison group: researchers will compare tdi s' wave velocity findings with the final adjudicated diagnosis of acs (determined after 3 months) to evaluate its sensitivity and specificity.


Eligibility criteria:
inclusion criteria: * age ≥18 years * presenting to the emergency department (ed) with acute chest pain * no st-elevation myocardial infarction (stemi) on initial ecg * requiring continuous cardiac monitoring based on triage decision * able to provide informed consent (written consent required) exclusion criteria: * known pre-existing cardiomyopathy (e.g., hypertrophic cardiomyopathy, dilated cardiomyopathy) * severe valvular heart disease * left bundle branch block (lbbb) or presence of a pacemaker * arrhythmias (e.g., atrial fibrillation, frequent premature ventricular contractions) * cardiac arrest or cardiogenic shock at presentation * pulmonary hypertension * pericardial effusion or tamponade * non-cardiac cause of chest pain suspected as the primary diagnosis * language barrier preventing informed consent (study materials available in english, french, and dutch)

Keywords: acute coronary syndrome (acs) non-st elevation myocardial infarction (nstemi) unstable angina tissue doppler imaging (tdi) echocardiography s' wave velocity mitral annular plane systolic excursion (mapse) tricuspid annular plane systolic excursion (tapse) emergency medicine diastolic function point-of-care ultrasound (pocus) bedside echocardiography cardiac function assessment early acs detection regional wall motion abnormalities diagnostic accuracy
a phase iii clinical trial of procrit (epoetin alfa) versus placebo in women undergoing adjuvant chemotherapy for stage i, ii or iii breast cancer

Conditions: Anemia; Breast Neoplasms; Hemoglobins; Quality of Life; Chemotherapy, Adjuvant

Summary: the purpose of this study is to determine whether it is possible to measure temporary difficulty with thinking and/or short-term memory in women who are receiving chemotherapy for early stage breast cancer and to determine whether or not treatment with procritâ® will help decrease any problems with thinking or short-term memory that chemotherapy may cause.

studies of the effect of erythropoietin on rat and mouse brain suggests a neuroprotective and cognitive-enhancing effect of this hormone. the objective of this study was to quantify and compare the incidence of chemotherapy-related impairment of cognitive and executive function in breast cancer patients randomized to receive procrit versus placebo while receiving adjuvant anthracycline-based chemotherapy with or without a taxane and to evaluate the effect of procrit® on the incidence of asthenia (severe fatigue), quality of life (qol), and mood. patients received study medication injections (40,000 units) under their skin once every week for 12 to 24 weeks of chemotherapy. doses were adjusted depending on the patients' hemoglobin level up to a maximum of 60,000 units.

Eligibility criteria:
inclusion criteria: * histologic diagnosis of stage i, ii or iii cancer (chemotherapy naïve for breast cancer) with anthracycline-based adjuvant chemotherapy with or without a taxane * hemoglobin \>=9 and \<=14 g/dl unrelated to transfusion * able to read, understand and complete qol \& cognition tools * patients with reproductive potential must have a negative serum pregnancy test within 7 days of study enrollment and use an adequate contraceptive method exclusion criteria: * patients who will receive more than a total of 24 weeks of chemotherapy * psychiatric or neurologic condition that would prevent informed consent and completion of questionnaires or that is poorly controlled with the current treatment regimen * severe hemiparesis or other condition, distal neuropathy, action tremor or other motor dysfunction, visual deficiencies preventing/decrease bimanual keyboard operation * severe bradyphrenia (slow thinking) or bradykinesia (slow movement)

Keywords: anemia breast cancer hemoglobin quality of life adjuvant chemotherapy pure red cell aplasia (prca) cognitive and executive function
a trial of diabetes-educated psychologist to improve hba1c and reduce diabetes-related distress

Conditions: Type1diabetes; Psychology Functional Behavior

Summary: type 1 diabetes is associated with a significant increase in mortality, cardiovascular disease, injuries on eyes and kidneys. these risks are largely dependent on glycemic control. multiple strategies of achieving good glycemic control exist. despite this, only about 20 % of patients in sweden reach the target hba1c of ≤ 52 mmol/mol. it is well-known that when the motivation is high, a large proportion of patients reach good glycaemic control with current treatments, e.g. most pregnant women reach a much better glycaemic control. the patient is then motivated to a greater extent in managing the disease, e.g. by carefully dosing insulin and more closely monitoring blood glucose levels. moreover, besides lack of motivation, specific psychiatric conditions are well-known barriers in being compliant with treatments such as depression, eating disorders and attention deficit disorders (adhd). further, identified specific diabetes-related psychosocial factors include severe fear of hypoglycaemia, diabetes-burnout, unrealistic treatment goals, poor relationship with physician, feelings of powerlessness and treatment skepticism. these parameters can be measured via a diabetes distress scale where a high score is correlated to higher hba1c. the majority of outpatient diabetes clinics in sweden today request the resource of a diabetes-educated psychologist. however, more evidence is needed from randomized multicentre trials whether such a resource would help to improve hba1c, reduce diabetes-related distress and improve quality of life. the primary aim of the current study is to evaluate whether the assistance of a diabetes-educated psychologist in the diabetes care of patients with type 1 diabetes improves hba1c. secondary endpoints include studying its influence on diabetes-related distress and quality of life. the study is a 1 year randomized trial where the intervention group will meet with a diabetes-educated psychologist in addition to conventional care.


Eligibility criteria:
inclusion criteria: * informed consent obtained before trial-related activities (i.e., any activity that would not have been performed during routine patient management) * clinical diagnosis of type 1 diabetes * adult patients over 18 years of age * hba1c \> 62 mmol/mol exclusion criteria: * type 2 diabetes * diabetes duration \<1 year * long-term systemic glucocorticoid treatment during the last 3 months * changed treatment the last 3 months regarding mdi vs. insulin pump or added or stopped cgm or fgm therapy * current or planned pregnancy or breastfeeding during the next 12 months * planned move during the next 12 months making it not possible to participate in study activities * other reason determined by the investigator not being appropriate for participation
effects of hyperoxia on open heart surgery

Conditions: Heart Valve Disease; Coronary (Artery) Disease

Summary: patients undergoing open cardiac surgery will be randomized into two groups. group i will be ventilated with 40% fio2 during induction, surgery and in postoperative care unit. group ii will be ventilated with 100% fio2 during induction and with 60-70% ( determined according to the arterial blood gas sample results) during surgery and in postoperative care unit. hemodynamic parameters ( systolic arterial pressure, diastolic arterial pressure, heart rate ), arterial blood gas samples ( pao2, paco2, ph, oxygen saturation, lactate), and pre and post cardiopulmonary bypass superoxide dismutase and malonyl aldehyde levels.


Eligibility criteria:
inclusion criteria: * asa ii-iii * patients with ef higher than 50%. * patients undergoing elective open heart surgery on pump ( cabg, valve replacement) exclusion criteria: * patients with diabetes mellitus * patients with copd * patients with cerebral vascular disease * patients with hypoxia in arterial blood gas samples ( pao2 lower than 80 mmhg) and hypercarbia (paco2 higher than 45 mmhg)
cros application in ci

Conditions: Hearing Loss

Summary: bilateral profound sensorineural hearing loss (psnhl) is often treated with cochlear implants. the majority of bilaterally deafened patients, however, often only receive a unilateral cochlear implant (ci), with resultant limitations related to monaural listening. for unilateral ci users, the deficits inherently associated with monaural listening remain despite the considerable benefits achieved through implantation. providing bilateral input to monaural listeners (mls) overcomes some of these disadvantages. treatment by contralateral routing of signal (cros) hearing aids, where the signal of interest is routed from the impaired (deaf) ear to the normal cochlea for processing is a promising alternative in unilateral ci recipients who cannot benefit from bilateral cis. utilizing cros technology provides a less invasive alternative for patients who are unable or unwilling to undergo a second ci surgery and offers an innovative approach to resolving the auditory deficits associated with monaural listening. cros technology has been used to treat traditional monaural listeners since 1965. when applied to unilateral ci users, this novel approach can overcome a key limitation of current treatment by restoring access to sound from the non-implanted ear and improving speech perception in noise.


Eligibility criteria:
inclusion criteria: * unilateral advanced bionics ci recipient * ≥ 6 months ci-listening experience and/or better than 50%-word recognition on consonant-nucleus-consonant (cnc) word testing * english speaking exclusion criteria: * subjects who do not meet one or more of the above mentioned inclusion criteria are excluded from the study