Kornimate/medical-research-clean huggingface dataset:
extension phase of the chronicle® offers management to patients with advanced signs & symptoms of heart failure study

Conditions: Heart Failure

Summary: the purpose of the extension phase of the compass-hf study is to continue to observe the safety of the chronicle® implantable hemodynamic monitor (ihm) system and chronicle icd system and provide study doctors continued access to the heart pressure information recorded by the chronicle devices which may be used to help manage heart failure. the extension phase of the compass-hf study is limited to people who have already received the investigational system and are currently enrolled in a chronicle ihm or icd study.

for the purpose of the extension phase, the chronicle ihm and icd systems are for continued use in patients with moderate to severe heart failure and are intended to monitor hemodynamic information, including right ventricular and pulmonary artery pressures, heart rate and activity. the compass-hf extension phase includes the following chronicle ihm studies: * the chronicle ihm phase i/ii study, which was a 148 patient technology assessment study that began enrolling patients in 1998 and completed the endpoint driven follow up period of 3 months for safety and 12 months for efficacy in 2002 * the chronicle offers management to patients with advanced signs \& symptoms of heart failure (compass-hf) study, which was a 274 patient randomized study that began enrolling patients in 2003 and completed the endpoint driven follow up period of 6 months in 2005 * the pulmonary arterial hypertension pilot (pah pilot) study, which was a 24 patient pilot study that began enrolling patients in 2003 and completed the endpoint driven follow up period of 12 weeks in 2006 * the reducing decompensation events utilizing intracardiac pressures in patients with chronic hf (reducehf) study, which was a 400 patient randomized study that began enrolling patients in 2006 and completed endpoint driven follow up period of 12 months in 2010. in all four studies, patients were implanted with a chronicle ihm or icd system and upon completion of the endpoint driven follow up period, entered long term follow up and have continued to be seen every six months for study visits. as the chronicle ihm or icd system has not received u.s. food and drug administration approval, the compass-hf extension phase is being initiated as a means to allow continued access of chronicle ihm data to study investigators in one concurrently enrolled study and follow up schedule. no additional study objectives or new enrollments will be captured in the compass-hf extension phase.

Eligibility criteria:
inclusion criteria: * patient provides written informed consent for the extension phase * patient has an implanted chronicle ihm or icd device and is actively enrolled in one of the following studies: compass-hf, chronicle ihm phase i/ii, reducehf or the pah pilot study exclusion criteria: * patient unwilling to transmit their chronicle ihm or icd device data as directed by their study clinicians or unwilling to participate in protocol scheduled follow up visits (every six months)
prevalence of wtattr-cm after carpal tunnel release surgery

Conditions: Transthyretin Amyloidosis; Transthyretin Cardiac Amyloidosis; Wild-Type Transthyretin-Related (ATTR)Amyloidosis

Summary: patients above the age of 60 will be recruited at their carpal tunnel release surgery. biopsies will be taken from the wrist and examined for the presence of amyloid protein. a amyloid-positive biopsy will refer the patients for cardiac examination including blod- and urine samples examined for transthyretin. if the result of the cardiac examination is suspected cardiac amyloidosis, the patient will be referred for a diagnostic tc99-dpd scintigraphy. if the scintigraphy is positive, the patient will be referred for right heart catherization (rhc) and an exercise test. myocardial biopsies will be taken at the rhc and examined with electron microscopy and high resolution respirometry.


Eligibility criteria:
inclusion criteria: * males above 65 years of age, females above 75 years of age. * scheduled idiopathic carpal tunnel release surgery. * informed written consent. exclusion criteria: * operation by other indication, e.g. * fracture * ganglion * known amyloidosis
evaluation of patients in chest pain in the emergency room

Conditions: Acute Cardiac Ischemia

Summary: the primary objective of this feasibility study is to determine whether it is possible to conduct a study of the clearview scan among patients under evaluation for acute cardiovascular events, as well as give insight into the performance of the clearview scoring algorithm with respect to this patient population. the epic™ scan is a bio-electrographic tool that may assist the health care provider in rapid assessment of the systemic origin of the patient's presenting symptom(s). the epic clearview is a potentially valuable resource that may benefit an emergency department (ed) by offering expedited "chest pain" etiologic differentiation capabilities. the subsequent results have the potential to include more rapid "chest pain" patient diagnosis and appropriate disposition of non-cardiac chest pain (rule out mi); optimized precious resource expenditure (nursing, physician, inpatient or observation bed, etc.); lower costs to facility, patient and insurance company; and greater patient satisfaction rates due to decreased ed wait time.


Eligibility criteria:
inclusion criteria: 1. sex: male or female 2. age range: 18 to 85 3. chief complaint upon admission to the ed: chest pain 4. the patient or legal representative is able to understand and provide signed consent for the procedure. 5. every effort will be given to balance subjects by gender, age, and race. exclusion criteria: 1. patients \ 85 years in age. 2. inability or unwillingness to provide informed consent. 3. patients with pacemakers or another electrical device, such as an automatic internal cardiac defibrillator, implanted somewhere in their body. 4. patients connected to an electrical device that cannot be removed (i.e. monitor). 5. pregnant women. 6. patients currently undergoing therapy for cancer of any kind. 7. patients missing all or part of any of their fingers. 8. patients with hand tremors or involuntary oscillations ("shaking") of the hands that prevent clear imaging.
bone metabolism adjacent to hip prosthetic surfaces. a clinical f-pet/ct study

Conditions: Hip Osteo Arthritis

Summary: what is the intensity of f-pet uptake adjacent to four analyzed hip endoprosthetic components and in healthy femur and acetabulum, 1, 4 and 9 months after surgery?

a clinical study of 32 patients, age 50-69 years, healthy unless osteoarthritis in one hip, randomized in two groups (16 each) plus a reference group of same 32 patient´s contralateral healthy hip. intervention will be surgery with a total hip arthroplasty. the four studied endoprosthetic components are: * cemented exeter stem (stryker warsaw, usa) with a ceramic 32 mm head and palacose cement with gentamycin, applied with 3:rd generation cementation technique. * uncemented lubinus sp-cl stem (waldemar link, hamburg, germany) with a ceramic 32 mm head. * uncemented delta pf cup (limacorporate spa, udine, italy). * uncemented fibrous metal delta tt cup (limacorporate spa, udine, italy). both cups will have cross linked ultra-high-molecular-weight polyethylene (uhwmp). clinical score, radiography and uptake of fluoride tracer will be analyzed.

Eligibility criteria:
inclusion criteria: - patients diagnosed to have unilateral hip osteo arthritis verified by radiography (charnley group a) aimed for tha at gävle hospital and accepting to participate in the study. exclusion criteria: * any systemic disease (other than osteo arthritis) or medication affecting skeleton methabolism
study of the effect of vagus nerve stimulation on human brown adipose tissue activity

Conditions: Obesity

Summary: to evaluate the effect of vagus nerve stimulation for refractory epilepsy on the activity of human brown adipose tissue.


Eligibility criteria:
inclusion criteria: * subjects treated with vns for epilepsy, aged 18-65 years, with a body mass index (bmi) ≤ 28 kg/m2. exclusion criteria: * body mass index \> 28 kg/m2 * daily epileptic insults. * subjects that need 'rapid cycling' vns to control their frequency of epileptic insults. * psychological unstable subjects (as judged by the treating neurologist). * subjects with mental retardation (as judged by the treating neurologist). * subjects with severe behaviour disorders (as judged by the treating neurologist). * pregnant subjects. * subjects that previously underwent high dose radiation for diagnostic or therapeutic purposes (radiotherapy, high frequency ct-scans). * the use of the following medication is an exclusion criterium; * ß-blockers, * ketogenic diet

Keywords: human brown adipose tissue activity obesity energy metabolism adaptive thermogenesis
involvement of nervous system in muscle weakness in copd patients

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to determine whether nervous system alterations and motor drive failure can contribute to muscle weakness in copd during voluntary movement. if necessary, we will look after the role of nocturnal hypoxia in these alterations.

copd is a common disease that induces many systemic repercussions. among these, peripheral muscle dysfunction is particularly deleterious because it leads to the decreases of the level of activity and the quality of life for patients. movement involves activation of many structures, from the instructor, i.e. the brain, to the effector, i.e. the muscle. netherless, the studies which have described peripheral muscle dysfunction have been focused on the muscle, so they have proposed a reducing vision of the phenomenon. other studies have reported cerebral alterations in copd, like cognitive disturbance, increase of the neuronal conduction time, and decrease of the white matter density, and were associated with chronic hypoxemia. such alterations are consistent with the existence of a decrease of the central motor drive during voluntary movement in copd patients. therefore the study will aim to determine precisely which mechanisms are involved in peripheral muscle dysfunction in copd.

Eligibility criteria:
inclusion criteria: * copd patients at stage 2 and 3 * healthy sedentary subjects exclusion criteria: * epilepsy, pace-maker, nervous disorders

Keywords: copd, nervous system, peripheral muscle dysfunction
implantation of add on lens for age related macular degeneration patients with low vision

Conditions: Inclusion Criteria

Summary: age related macular degeneration (amd) is the leading cause of vision loss in patients older than 55 years old. amd can present as dry amd or wet amd. in most cases amd affects both eyes although in many cases it's asymmetrical as far as severity. some patients require low vision aids to continue their daily life tasks. in the past a few attempts were made to use low vision intraocular lenses with corrective glasses without enough success. in addition telescopic and prismatic lenses were also tried. the difficulties with these lenses included low field of vision, unsatisfactory magnification, complicated surgical technique and high complication rates. recently an add on lens was designed for the sulcus for implantation in pseudophakic amd patients. the add on lens doubles the magnification of the central image dependent on the reading distance and the anatomy of the eye. the lens is acrylic hydrophobic and designed for implantation in the sulcus either in pseudophakic patients or in addition to an intraocular lens implanted during a routine cataract surgery. the lens is 13 mm wide with 4 symmetric haptics. the lens has 1.5 mm central part of 10 diopters and the rest of the lens has no optical power. our purpose is to study implantation of the lenses in amd patients to improve their reading ability and to improve their daily living.

study design prospective study on implantation of the add on lenses in amd patients. the study was approved by rabin medical center irb. patients will be examined for best corrected visual acuity prior to the surgery at 6 meter and for reading at 40 and 15 cm. improvement of the reading ability at 15 cm compared to 40 cm will predict the potential for vision improvement with the add on lens. before the surgery patients will have a full ophthalmological examination. patients will have axial length and keratometry examination using the biometry. the lens will be implanted in surgery through a 2.2 mm clear cornea and will be injected and positioned in the sulcus. patients will be followed up at 1 day, 1 week, 4 weeks, 4 and 6 months following surgery. during follow up patients will undergo full ophthalmic exam and well as visual acuity both for distance and near.

Eligibility criteria:
inclusion criteria: * pseudophakic patients with non-active amd that complain on near distance reading with a distance visual acuity better than 6/60. exclusion criteria: * exudative amd with fluids, advanced glaucoma, advance visual field defects, aphakia, following complicated cataract surgery with pciol in the sulcus , phacodonesis, chronic uveitis, rubeosis iridis, central corneal opacity.
a multicenter, randomized, double-blind, placebo-controlled trial of intravenous ibuprofen 400 and 800 mg every 6 hours in the management of postoperative pain.

Conditions: Ibuprofen; Nonsteroidal Anti-inflammatory Drug; Intravenous; Injectable; Pain; Analgesic

Summary: this study was to evaluate the efficacy and safety of intravenously administered ibuprofen 400mg and 800 mg q6h for the management of moderate to severe postoperative pain in chinese population.

this randomized, parallel, double-blind, placebo controlled multi-center clinical study was conducted in 396 patients scheduled to undergo elective general anesthesia laparotomy or orthopedic surgery. patients were randomly divided into three groups in radio 1:1:1 received respectively iv placebo, ibuprofen 400 mg or ibuprofen 800 mg. the first dose of study drugs was administered intravenously at the time of wound closure and then every 6 hours within 48 hours after the operation. at the end of surgical suture, 5mg morphine was injected intravenously, and then the patient-controlled intravenous analgesia pump was connected. efficacy was assessed by morphine dosage during the first 24 hours, pain intensity score, and area under the pain-time curve after surgery. safety was assessed by the incidence of adverse events.

Eligibility criteria:
inclusion criteria: * enrollment was open to patients undergoing scheduled abdominal surgery (intestinal or lower abdomen) or orthopedic surgery (such as knee arthroplasty or shoulder joint reconstruction) under general anesthesia with endotracheal intubation and were expected to require patient-controlled intravenous analgesia (pcia) pump for more than 24h for moderate to severe pain after surgery. exclusion criteria: * those who can not understand the nrs score and cooperate with the evaluation; those who had head trauma or complicated with organic lesions of the central nervous system within 4 weeks before operation; those who developed coagulation dysfunction or took anticoagulants and antiplatelet drugs; those with a history of severe cardio-cerebrovascular disease, heart failure; those with liver and kidney dysfunction, severe endocrine system diseases, mental illness; those with a history of peptic ulcer or bleeding; those who did not control grade 2 or above hypertension or were still taking two or more of antihypertensive drugs such as angiotensin converting enzyme inhibitors (acei), angiotensin converting enzyme antagonists (arb) and diuretics at admission; increased toxicity due to the interaction of methotrexate, lithium preparations, etc. with the test drug; use of nsaids or analgesic muscle relaxants within 24 hours before operation, narcotic dependence or tolerance; allergy to ibuprofen or other nsaids; pregnant or lactating women
behavioural activation (ba) for postnatal depression in blackpool

Conditions: Postnatal Depression

Summary: is behavioural activation feasible, acceptable and potentially effective for mothers experiencing post natal depression in blackpool? phase 1: a series of single case studies which aim to examine and refine a) the appropriateness of the programme to women in blackpool b) the suitability of ba as part of a stepped-care approach to perinatal mental health within the health visitor pathway and c) the delivery of the programme in practice. phase 2: a preliminary single group study examining the quantitative outcomes for participating women (i.e. symptoms of depression, anxiety and general mood, parental stress, responsiveness, and behavioural avoidance and activation.


Eligibility criteria:
inclusion criteria: * 18 years or older * score between 10-19 on phq9 * have given birth within the last 6 months * willing to engage in a psychological therapy * informed, prepared and safe to participate in the programme * able to understand spoken and basic written english exclusion criteria: * under 18 years old * score under 10 or over 19 on the phq9 * receiving another from of psychological treatment for depression * unwilling to engage in a psychological therapy * another primary area of difficulty which takes precedence over the current programme (e.g.substance dependency disorders, suicidal crises, frequent, serious and deliberate self-harm, acute threat in the form of serious interpersonal violence from a partner or friend or family member, and evidence of more serious mental health disorders which may require additional support, i.e., psychotic disorders, bipolar disorder

Keywords: psychoeducation, mental health, depression, postnatal
pharmacokinetic study of single and repeated dose of roflumilast 500 µg , in healthy chinese subjects

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the primary objective is to assess the pharmacokinetics (pk) of roflumilast and its metabolite roflumilast n-oxide after single and repeated oral administrations of roflumilast 500 μg in healthy chinese subjects.


Eligibility criteria:
main inclusion criteria: * healthy male and female (24 male and 8 female) subjects of chinese ethnic origin, age 40 years and older. * assessed as healthy based on a screening examination including medical history, physical examination, blood pressure, pulse rate, ecg assessment, and clinical laboratory results. * body weight according to a body mass index (bmi) between 19 and 28 kg/\[m²\], (both inclusive) and a body weight ≥ 50 kg. * females with childbearing potential who are using medically acceptable and reliable method of contraception for the entire study duration, such as tubal ligation, hysterectomy, intrauterine device without hormones or post-menopausal females, the latter is defined as females who have had no menstrual period for at least 2 years. main exclusion criteria: * history or current evidence of clinically relevant allergies or idiosyncrasy to drugs or food * history of allergic reactions to roflumilast or any inactive ingredients of the trial medication * history or current evidence of any clinically relevant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrinological, metabolic, neurological, psychiatric, or other disease (within the last 2 years) * history of malignancy within the past 5 years * electrocardiogram (ecg) abnormalities of clinical relevance (e.g. qtc according to bazett's formula: qtc \> 450 msec (male), qtc \> 470 msec (female), pq ≥ 220 msec) * blood pressure ≥ 140 mm hg systolic or ≥ 90 mm hg diastolic * elevated transaminases \> 2 x upper limit of normal range and or increased of the total bilirubin \> 1.5 upper limit of normal range * clinically relevant abnormalities in clinical chemical, hematological or any other laboratory variables * chronic or clinically relevant acute infections * proneness to orthostatic dysregulation, faintings, or blackouts * positive results in any of the virology tests of acute or chronic infectious hiv and hepatitis a, b, and c virus infections * positive drug screen * abuse of alcohol or drugs * positive β-hcg pregnancy test (female) * pregnant or lactating females

Keywords: pharmacokinetic roflumilast
different methods of capecitabine in patients with non-pcr after neoadjuvant therapy for tnbc

Conditions: Triple Negative Breast Cancer

Summary: the survival rate of patients with pathological complete response (pcr) after neoadjuvant therapy was significantly better than that of patients with tumor residue, that is, non-pcr patients. therefore, studies have confirmed that intensive adjuvant therapy for patients with non-pcr after neoadjuvant chemotherapy can further improve the survival of this population. previous studies have given capecitabine treatment to such patients as standard. however, it is unknown whether capecitabine intensification still has the same status under the premise that most patients receive immunotherapy at the neoadjuvant stage; whether there are differences in the efficacy and safety of capecitabine standard 6-8 cycle intensive regimen and capecitabine metronomic chemotherapy are practical problems encountered in clinical practice. this study explored the efficacy and safety of 6-8 cycles of full dose capecitabine intensive therapy compared with 1-year capecitabine metronomic chemotherapy in patients with t2 and above and/or lymph node positive early triple negative breast cancer who still had invasive tumor after neoadjuvant therapy.


Eligibility criteria:
inclusion criteria: * 1) patients with triple negative breast cancer diagnosed by biopsy in peking university people's hospital; * 2) the clinical stages before treatment were t1-t4, n0-n3, m0; * 3) received treatment and operation in our hospital, and had hospitalization records; * 4) neoadjuvant chemotherapy is unlimited, and immunotherapy is allowed in neoadjuvant and/or adjuvant treatment; * 5) postoperative pathology confirmed the presence of residual invasive breast cancer in the breast and/or axillary lymph nodes; * 6) has signed and agreed to participate in the pkuph breast disease cohort study. exclusion criteria: * 1) lack of clinical and pathological data (such as imaging data and pathological data); * 2) patients with metastatic breast cancer or bilateral breast cancer; * 3) failure to perform radical surgery; * 4) brca has pathogenic or possibly pathogenic mutations, and received intensive treatment with parp inhibitors after operation

Keywords: neoadjuvant chemotherapy adjuvant chemotherapy non-pcr capecitabine
sleep efficiency assessed by polysomnography (psg sleep lab testing) in advanced parkinson's disease

Conditions: Advanced Idiopathic Parkinson's Disease

Summary: this is a phase 4 study to evaluate with polysomnography (psg) and subjective measures the effect of rotigotine on sleep efficiency, maintenance, insomnia, nocturnal akinesia and night-time movement in bed, in patients with advanced parkinson's disease.


Eligibility criteria:
inclusion criteria: * advanced parkinson's disease (ie, takes levodopa (l-dopa)) * hoehn and yahr stage score of 2 to 4 * subject has sleep-maintenance insomnia exclusion criteria: * significant skin disease that would make transdermal drug use inappropriate * subject received therapy with controlled-release levodopa (l-dopa), entacapone or stalevo® within 28 days prior to the baseline visit or has received therapy with tolcapone * atypical parkinsonian syndromes * previous diagnosis of narcolepsy, sleep apnoea syndrome, significant rapid eye movement (rem) sleep behavior disorder (rbd), moderate to severe restless legs syndrome (rls) or periodic limb movement disorder

Keywords: rotigotine neupro polysomnography sleep efficiency advanced idiopathic parkinson's disease sleep disorder