Kornimate/medical-research-clean huggingface dataset:
open label study to evaluate the long-term safety profiles of caduet in japanese patients

Conditions: Hypertension; Hypercholesterolemia; Angina Pectoris

Summary: the primary objective is to investigate the safety of caduet (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg or 5 mg/10 mg as dose of amlodipine/atorvastatin) during 52 weeks treatment period in japanese patients with both of hypertension and hypercholesterolemia, or with both angina pectoris and hypercholesterolemia.


Eligibility criteria:
inclusion criteria: * subject with both hypertension and hypercholesterolemia must meet the following (1), and the following (2) or (3): * (1) subjects who take amlodipine 2.5mg/day or 5mg/day at least 28 days before week -2, and subjects with well controlled bp value (bp value \< 140/90mmhg at week 0) * (2) subjects who take atorvastatine 5mg/day or 10mg/day at least 28days before week -2 * (3) statin-naïve patient, defined as receiving no statin therapy for more than 3 months during the previous 12 months, with ldl-c ≥ 160 mg/dl, ldl-c \< 250 mg/dl, and tg \< 400 mg/dl at week -2 * subject with both angina pectoris and hypercholesterolemia must meet the following (1), and the following (2) or (3): * (1) subjects who take amlodipine 2.5mg/day or 5mg/day at least 28 days before week -2, and who meet the following criteria; subjects with well controlled bp value (bp value \< 140/90mmhg at week 0), and subjects with clinically stable of angina pectoris * (2) subjects who take atorvastatine 5mg/day or 10mg/day at least 28days before week -2 * (3) statin-naïve patient, defined as receiving no statin therapy for more than 3 months during the previous 12 months, with ldl-c ≥ 160 mg/dl, ldl-c \< 250 mg/dl, and tg \< 400 mg/dl at week -2 exclusion criteria: * subjects who need three or more multi-antihypertensive therapies to achieve the target bp level or uncontrolled status of hypertension at week 0 (v1); the target bp level is defined as systolic blood pressure \< 140mmhg and diastolic blood pressure \< 90 mmhg. * uncontrolled or uncontrollable status of hypercholesterolemia at week -2; a ldl-c ≥ 160 mg/dl even though atorvastatine 10 mg has administrated
physiopathology of neuromuscular function related to fatigue in chronic renal disease

Conditions: Chronic Kidney Disease Stage 3B; Chronic Kidney Disease stage4; Chronic Kidney Disease Stage 5; Fatigue

Summary: chronic kidney disease (ckd) induces many metabolic troubles especially for the advanced ckd (stage 3b-5) patients and their prevalence and importance grow with the deterioration of the glomerular filtration rate (gfr). among them, muscle wasting is common and multifactorial, partially explained by an imbalance between protein catabolism and synthesis. muscular strength is also affected beyond the reduction of the lean body mass, resulting in profound fatigue. the present study seeks to quantify the prevalence of low muscular strength production (dynapenia) in a cohort of elderly patients with advanced ckd, through a maximal voluntary contraction (mvc) handgrip test compared to control data available in the literature, matched in term of age and sex. it also aims to investigate the link between the reported fatigue (subjective) and the evolution of the mvc, called critical force (fcrit) during a fatiguing task (objective fatigability).


Eligibility criteria:
inclusion criteria: * adults, aged 60 and over * social security coverage * signed informed consent * for patient with chronic kidney disease, estimated glomerular filtration rate (egfr) less than 45ml/min/1.73m2 (stage 3b) for at least 3 months * for patient with chronic kidney disease, stable clinical condition (i.e., creatinine increased by a maximum of 25% in the previous 3 months) * for control group, 1:1 recruitment with case matching with cdk patients on gender (i.e., male and female) and the presence of diabètes (i.e., presence and absence) * for control group, blood test with control of renal function available and dated less than 6 months: with egfr \> 60ml/min/1.73m2 (and control of glucose or glycated hemoglobin for diabetic controls) exclusion criteria: * pregnant women * under guardianship or minor * neuromuscular disease * dementia * upper limbs history of surgery or pathologies preventing from fitting emg electrodes or measuring handgrip force * life expectancy of less than 3 months estimated by medical judgment * programed hospitalization in the previous 3 months * participation to another interventional clinical trial * acute kidney disease * on dialysis or expected start of dialysis within next 3 months

Keywords: neuromuscular abilities dynapenia over-60-year-old patients
feasibility study of sol (s-1,oral leucovorin,and oxaliplatin) in patients with advanced gastric cancer

Conditions: Gastric Cancer

Summary: in china, s-1 is an novel oral fluoropyrimidine with demonstrated high efficacy on gastrointestinal cancer. the new regimen with oxaliplatin and leucovorin is expected to achieve more encouraging efficacy on gastric cancer. this study is aimed to evaluate the feasibility of the sol regimen on efficacy and tolerability on chinese patients with advanced gastric cancer.


Eligibility criteria:
inclusion criteria: * age over 18 years old * histologically or cytologically documented gastric adenocarcinoma * performance status (ecog scale): 0-2 * life expectancy ≥ 3 months * no previous treatment(including: radiotherapy,chemotherapy and immunotherapy) * prior systemic therapy (for instance, cytotoxic chemotherapy or active/passive immunotherapy) for adjuvant or neoadjuvant treatment for non-metastatic (m0) disease has been completed within 6 months prior to initiation of study treatment. * with measurable target lesion * patients should sign a written informed consent before study entry exclusion criteria: * history of hypersensitivity to fluoropyrimidines, s-1, oxaliplatin or the ingredients product * inadequate hematopoietic function: wbc≦5,000/mm3; anc≦2,000/mm3; platelet≦100,000/mm3 * inadequate organ function which is defined as below: total bilirubin \>2 pper limit of normal range (uln); alt / ast \> 2.5 upper limit of normal range (uln) (\>5.0 x uln if hepatic metastasis); serum creatinine \> 2 upper limit of normal range (uln); * symptomatic peripheral neuropathy ≥ nci ctc ae grade 1; * receiving a concomitant treatment with other fluoropyrimidines or fluorocytosine; * pregnancy or lactation women, or women with suspected pregnancy or men unless using a reliable and appropriate contraceptive method; * mental status is not fit for chemotherapy therapy presence of serious concomitant illness which might be aggravated by study medication; * history of ventricular arrhythmia or congestive heart failure; * active cardiac disease e.g. decompensate myocardial infarction within the 6-month period preceding entry into the study; * significant co-morbid medical conditions, including, but not limited to, chronic obstructive pulmonary disease, interstitial pneumonia ,pulmonary heart failure, renal failure, hepatic failure, haemorrhagic peptic ulcer, mechanical, paralytic or poor control diabetes

Keywords: s-1 oxaliplatin leucovorin gastric cancer
taekwondo training and postmenopausal women with stage-2 hypertension

Conditions: Menopause; Hypertension

Summary: aging is associated with hormonal imbalances and progressive decreases in arterial health and function. it is crucial to prevent or reduce the negative effects of aging on hormonal balance and the vasculature by implementing appropriate lifestyle interventions, such as exercise training. we examined the effects of a 12-week taekwondo training program on blood catecholamines, arterial stiffness (pulse wave velocity, pwv), blood pressure (bp), resting heart rate, and muscular strength in postmenopausal women with stage 2 hypertension.

using a parallel experimental design, participants were randomly assigned to either a taekwondo exercise training group (n=10) or non-exercising control group (n=10) for 12 weeks. participant in the taekwondo training group trained 3 days/week for 60 minutes per session, and the intensity progressed weekly. participants in the control group performed no exercise intervention.

Eligibility criteria:
inclusion criteria: * be diagnosed with stage-2 hypertension * be postmenopausal * be between 65 and 85 years old exclusion criteria: * known cardiovascular, metabolic or renal diseases * physical limitations that prohibit exercise * participates in regular exercise

Keywords: taekwondo menopause hypertension arterial stiffness blood catecholamines
clinical and economic consequences of left atrial bipolar radiofrequency ablation of persistent and permanent atrial fibrillation during cardiac surgery

Conditions: Atrial Fibrillation; Coronary Artery Disease

Summary: the clinical effects of intra-operative radiofrequency ablation in patients with persistent or permanent atrial fibrillation and an indication for an implantation of a heart valve prosthesis or coronary bypass surgery are the purposes of this study. the study will examine if and to what extent the quality of life and the use of medical care differs between patients with and without ablation. furthermore, there will be thorough echocardiographic examinations of the heart to detect differences between the different treatment groups. the patients will be followed for one year after treatment.


Eligibility criteria:
inclusion criteria: * persistent atrial fibrillation * permanent atrial fibrillation * mitral valve defect * tricuspid valve defect * aortic valve defect * coronary artery disease exclusion criteria: * pregnancy * age \ 75 years * emergency surgery * left dominant coronary circulation (relative contraindication) * coronary arteries of the posterior wall without pathological findings: no inclusion * stenosis of the posterior wall vessels, supplied with a cabg (coronary artery bypass grafting): inclusion possible * left ventricular ejection fraction \< 30% * size of the left atrium \> 7 cm * thrombosis of the left atrial appendage * leads in the coronary sinus * atrial flutter * infective endocarditis * reoperation * participation in other studies * life expectancy of less than 12 months * psychiatric disorders * hyperthyreosis

Keywords: persistent atrial fibrillation permanent atrial fibrillation mitral valve defect tricuspid valve defect aortic valve defect
ketamine to treat patients with post-comatose disorders of consciousness

Conditions: Disorder of Consciousness

Summary: the investigators will run a randomized clinical trial with 30 patients with disorders of consciousness (doc), with intravenous subanesthetic doses of ketamine. patients will simultaneously undergo tms-eeg. the piloting will be done on 3 patients, with eeg only.

the protocol will be organized in three phases: baseline, experimental, and follow-up. in the baseline, patients will receive a multimodal assessment \[functional magnetic resonance imaging (fmri), positron emission tomography (pet), electroencephalogram (eeg)\]. the experimental phase is made of 2 sessions spaced 5 days apart: on day 1, patients will receive placebo (or ketamine), on day 5 patients will receive ketamine (or placebo). the order will be randomized and balanced. the investigators will use a targeted-controlled infusion (tci) system to infuse a continuous subanesthetic dose of ketamine, which is known to have psychedelics effects, or a saline solution. the investigators will periodically assess for new signs of consciousness with the "simplified evaluation of consciousness disorders" (seconds) scale. the investigators will use transcranial magnetic stimulation coupled to eeg (tms-eeg) to measure brain activity and calculate brain complexity. tms-eeg will be performed from 20 minutes before the beginning of the infusion up to the max duration of the experiment (90 minutes). another seconds will be performed on the following day of each session to control for carry-over effects. the primary outcomes are the emergence of new conscious behaviours and higher brain complexity following ketamine infusion. the secondary outcomes are baseline brain differences in neurophysiological and brain imaging measures between responders (new conscious behaviors or higher brain complexity) and non-responders (no new conscious behaviors or higher brain complexity). in the follow-up phase, patients' health will be evaluated at 1, 6, and 12 months.

Eligibility criteria:
inclusion criteria: * clinically stable * diagnosis of uws or mcs based on repeated "coma recovery scale-revised) (crs-r) or seconds * more than 28 days post-insult * informed consent from the legal representative of the patient exclusion criteria: * neurological medications other than anti-spasticity drugs in the last 2 weeks or 4 half-lives * previous neurological functional impairment other than related to their doc * a history of psychotic disorders * contraindication to mri, eeg, pet or tms * use of nitrates or other vasodilators, central nervous system acting agents such as barbiturates, morphine and related drugs. * use of drugs known to interact with ketamine (i.e., cyp3a4, diazepam, ...) * coronary insufficiency * other sympathomimetic drugs

Keywords: psychedelics complexity ketamine clinical diagnosis consciousness level
prospective study of antenatal diagnostic criteria for digestive complications of gastroschisis

Conditions: Gastroschisis; Intestinal Occlusion

Summary: gastroschisis is a rare congenital malformation consisting in a right para-umbilical defect of the abdominal wall leading to an evisceration of the abdominal content. about 25% of the cases are associated with intestinal malformation, leading to an increase in peri-natal morbidity and mortality. no prospective study has been able to definitely describe predictive factors for complicated gastroschisis on prenatal ultrasound examinations. the aim of the current study is to prospectively look for us prenatal features predictive of complicated gastroschisis, on a national multicentric cohort. patients will be included during the 22 weeks of amenorrhea (wa) ultrasound examination, and pre- and postnatal clinical data will be recorded up to the 6th months of the child. data will then be analysed and compared in the groups of simple or complicated gastroschisis, in order to define pre-natal prognostic factors, to correlate them with specific prognosis, and to might better determine specific strategies for better care of these patients.


Eligibility criteria:
inclusion criteria: every volunteer pregnant woman, in whom an antenatal ultrasound diagnosis of gastroschisis has been carried, before the end of 22 weeks of amenorrhea. exclusion criteria: lack of informed consent or refusal of the person to participate in study

Keywords: gastroschisis prenatal diagnosis gastrointestinal complications wall defect predictive factors
reader study of deltaview™ chest radiograph software

Conditions: Lung Neoplasm

Summary: a new software product takes two chest radiographs, aligns them, and then subtracts one image from the other. the resulting image represents an image showing any differences between them. the study is to determine whether radiologists using this new software perform better with it than when they do not use it.


Eligibility criteria:
inclusion criteria: for radiologists: american board of radiology certification and live within the baltimore, md-washington, dc metropolitan areas for chest radiographs, evidence of the presence or absence of lung nodule confirmed by expert panel; adequate image quality - exclusion criteria: radiologists who assisted by providing cases for review for chest radiographs: poor image quality

Keywords: lung neoplasm nodule image processing computer-assisted
repetitive nerve stimulation to improve recovery after stroke

Conditions: Stroke

Summary: upper limb paresis is the most common type of post-stroke neurological impairment and a major cause of functional disability. repetitive peripheral sensory stimulation (rpss) is a novel strategy to improve upper limb motor performance in the post-stroke chronic phase but its effects in the subacute phase are still poorly understood. the objectives of this study are to compare the effects of rpss on motor performance of the upper limb in the subacute and chronic phases of stroke, and to identify the mechanisms underlying this intervention.


Eligibility criteria:
inclusion criteria: * ischemic or hemorrhagic stroke confirmed by computed tomography or magnetic resonance imaging, between 7 days - 3 months before enrollment (subacute phase), and at least 6 months (chronic phase). * ability to perform at least 4 of 7 tasks performed in daily life that is part of the jebsen-taylor test exclusion criteria: * anesthesia of the paretic hand. * lesions affecting the motor cortex (hand area). * lesions affecting cerebellum, or cerebellar pathways in the brainstem. * severe spasticity at the paretic elbow, fist or fingers, defined with a score larger than 3 on the modified ashworth scale. * neurological diseases such as parkinson disease or chronic uncontrolled chronic disease such as cancer or cardiac insufficiency. * elbow pain or join deformity in the paretic limb. * pregnancy. * uncontrolled psychiatric disease. * aphasia or severe cognitive deficit. * inability to provide consent. * inability to attend the experimental sessions.

Keywords: rehabilitation neuromodulation peripheral stimulation motor function
a pilot study investigating the clinical use of tissue engineered vascular grafts in congenital heart surgery

Conditions: Single Ventricle Cardiac Anomaly

Summary: an initial feasibility and safety study evaluating the use of autologous tissue engineered vascular grafts as extra cardiac total cavopulmonary connection (ec tcpc) conduits in children with single ventricle anomalies.

this investigation is a prospective, nonrandomized phase 1 clinical trial determining the safety of the use of tissue engineered vascular grafts as conduits for ec tcpc. primary end points of the study will include determination of graft failure rates and graft related morbidity and mortality. graft failure will be defined as any graft narrowing/occlusion or dilation/rupture requiring surgical or endovascular intervention. graft related morbidity and mortality will include any post-operative complication such as any thromboembolic or infectious event that requires treatment and is thought likely to be caused by the tissue engineered vascular graft as determined by the investigators and confirmed by the data safety monitoring board. all appropriate patients requiring ec tcpc who meet study inclusion/exclusion criteria will be evaluated for enrollment in the clinical trial. after obtaining informed consent from the patient's parents, patients with single ventricle cardiac anomalies will undergo ec tcpc using a tissue engineered conduit. post-operative care and monitoring will follow an established, standardized, clinical algorithm in which the patient's clinical status including complications and measurements of graft function will be serially evaluated and recorded over a three year period using physical examination, echocardiography, and mra.

Eligibility criteria:
inclusion criteria: * single ventricle cardiac anomaly requiring extra cardiac total cavopulmonary connection (ec tcpc). exclusion criteria: * incomplete inferior vena cava (ivc)

Keywords: tissue engineered vascular graft
transcranial brain stimulation and its underlying neural mechanisms as a novel treatment for auditory hallucinations

Conditions: Psychotic Disorders

Summary: the present study aims to investigate whether transcranial direct current stimulation (tdcs) reduces auditory hallucinations in patients with psychosis. in addition, the neuronal changes of tdcs will be examined.

the majority of patients with psychosis experience hallucinations, particularly auditory hallucinations are frequent. the hallucinations often leads to massive distress and impairments in social functioning and sometimes even order patients to commit acts of violence against themselves or others. the standard treatment for auditory hallucinations is antipsychotic medication. however, side-effects can be severe and about 25-30% of the patients do not respond to the medication. transcranial direct current stimulation is a non-invasive brain stimulation technique, which modulates cortical excitability in a pain-free free with mild transient adverse effects, if any. typically, cortical excitability underneath the anode is boosted while cathodal stimulation has inhibitory effects. previous studies found that 2 daily sessions of 20 min tdcs for five subsequent days may reduce auditory hallucinations. investigators want to further assess the efficacy of tdcs in sample that is large enough to detect medium to large effects. in addition, investigators want to investigate the neural mechanisms that underlie the tdcs treatment by examining various neuroimaging parameters before, immediately after treatment, and 3 months after treatment.

Eligibility criteria:
inclusion criteria: * diagnosed with schizophrenia spectrum disorder or other psychotic disorder * frequent auditory hallucinations (at least 5 times a week). * patients are on a stable dose of antipsychotic medication (which can also be zero) for at least 2 weeks. * mentally competent for informed consent. * provided informed consent. exclusion criteria: * metal objects in or around the head that cannot be removed (i.e. cochlear implant, surgical clips, piercing) * history of seizures, or a history of seizures in first-degree relatives. * history of eye trauma with a metal object or professional metal workers * history of brain surgery, brain infarction, head trauma, cerebrovascular accident, broken skull, brain tumour, heart disease, cardiac pacemaker. * skin disease on the scalp on the position of the tdcs electrodes * coercive treatment based on a judicial ruling * pregnancy in female patients