Kornimate/medical-research-clean huggingface dataset:
dermasensor postmarket surveillance study

Conditions: Melanoma, Skin

Summary: the objective of this study is to evaluate the sensitivity of the dermasensor device and investigators when used on skin lesions concerning for melanoma.


Eligibility criteria:
inclusion criteria: 1. men or women of any ethnic group aged 40 and older 2. primary skin lesion suspicious for melanoma 3. patient is willing and able to read, understand, and sign the informed consent form (icf) exclusion criteria: 1. lesion is not accessible to the dermasensor device handheld unit and tip (e.g., inside ears, under nails, etc.) 2. lesion is on areas of psoriasis, eczema, acne, or similar inflammatory skin conditions that may impede appropriate dermasensor device tip placement on the lesion. 3. lesion is greater than 15mm in diameter at the widest point. 4. lesion has a targeted area less than 2.5mm in diameter where the dermasensor device tip cannot be placed entirely within the border of the targeted area of the lesion. 5. lesion has no contiguous area of at least 2.5mm due to ulceration, erosion or liquid discharge (e.g., blood). 6. lesion is covered by a crust or scale, and lesion surface cannot be cleared of crust or scale such that there is a contiguous area of at least 2.5mm of cleared intact skin that is free of any crust, ulceration, erosion or liquid discharge (e.g., blood). 7. lesion is obstructed by foreign matter that cannot be non-invasively removed (e.g., tattoo, splinter, etc.) 8. lesion is not completely cleared of (i.e., free of any remaining residue) dermoscopy oils, makeup, sunscreen, other topical solutions or powders, markings, and staining treatments (e.g., iodine). 9. lesion is located on acral skin (e.g., sole or palms). 10. lesion is located within 10mm of the eye. 11. lesion is on or adjacent to scars, areas previously biopsied, or areas subjected to any past surgical intervention. 12. lesion is located on mucosal surfaces (e.g. genitals, lips). 13. lesion is located in an area with acute sunburn. 14. dementia or other neurologic, physical or psychological limitation that would prevent the patient from signing informed consent and/or completing any required follow-up visits

Keywords: medical device skin cancer detection elastic scattering spectroscopy
study of the safety, tolerability and analgesic efficacy of multiple doses of ketorolac tromethamine (in) for postoperative pain

Conditions: Postoperative Pain

Summary: this was a randomized, double blind, placebo-controlled study in subjects who have undergone major surgery. each subject's study participation consisted of a screening visit, a 2-day treatment period, and a follow-up visit. following surgery, subjects were randomly assigned to receive intranasally (in) ketorolac 10 mg, in ketorolac 30 mg, or placebo when the pain intensity (pi) rating equaled at least 40 on a 100-mm visual analog scale (vas). thereafter, subjects received study drug every 8 hours, with the last dose given at 40 hours. for pain not relieved by the study drug, the subjects had access to morphine sulfate (ms) administered via patient controlled analgesia (pca). the primary objective was to evaluate the analgesic efficacy of multiple intranasal (in) doses of ketorolac over 2 days. the secondary objective was to evaluate the safety and tolerability of this dosing regimen.


Eligibility criteria:
inclusion criteria: * men or women, age 18 years or older * body weight \> or = 100 pounds (45.4 kg) and \< or = 300 pounds (136.1 kg) * women of childbearing potential must have had a negative serum pregnancy test result prior to entry into the study * able to provide written informed consent * at least moderate pain as determined by a pi score of \> or = 40 mm on a 100-mm vas * expected to remain in the hospital for at least 48 hours * willing and able to comply with all testing and requirements defined in the protocol * willing and able to complete the posttreatment visit exclusion criteria: * allergy or sensitivity to ketorolac or ethylene diamine tetraacetic acid (edta) * allergic reaction to aspirin or other nonsteroidal anti-inflammatory drug (nsaids) * current upper respiratory tract infection or other respiratory tract condition that could interfere with the absorption of the nasal spray or with the assessment of adverse events * use of any in product within 24 hours prior to study entry * clinically significant abnormality on screening laboratory tests * history of cocaine use resulting in nasal mucosal damage * active peptic ulcer disease, recent (defined as within 6 months) gastrointestinal bleeding or perforation, or a history of peptic ulcer disease or gastrointestinal bleeding * advanced renal impairment or a risk for renal failure due to volume depletion * a history of any other clinically significant medical problem, which in the opinion of the investigator would interfere with study participation * participation within 30 days of study entry or within 5 times the half-life, whichever is longer, in another investigational drug study * allergy or significant reaction to opioids * pregnancy or breastfeeding * previous participation in this study
whole genome sequencing versus whole exome sequencing for congenital diarrhea and enteropahty

Conditions: Diarrhea, Infantile; Enteropathy

Summary: this study will seek to determine if whole genome sequencing (wgs) improves diagnostic rates, and outcomes for congenital diarrhea and enteropathy (code) patients. the investigator will enroll 180 patients in a randomized controlled study to either wgs or whole exome sequencing (wes). this study is designed to evaluate whether code patients would benefit from wgs guided precision medicine.


Eligibility criteria:
inclusion criteria: * patients with chronic diarrhea lasting greater than 2 months * patients with consent from parents or legal guardians * biological relative of a patient enrolled in this study. exclusion criteria: * chronic diarrhea caused by specific infections, i.e. cmv, clostridioides difficile * chronic diarrhea with necrotizing enterocolitis, short bowel syndrome * functional diarrhea * patients with previously confirmed monogenic diarrhea * patients with poor compliance
educate: the medtronic endeavor drug eluting stenting: understanding care, antiplatelet agents and thrombotic events

Conditions: Coronary Artery Disease

Summary: educate is a prospective, multi-center study designed to collect real-world safety and clinical outcomes in subjects receiving one or more endeavor zotarolimus-eluting stents and either clopidogrel and aspirin or prasugrel and aspirin as part of a dual antiplatelet therapy (dapt) drug regimen.

to provide clinical information on rates of late and very late stent thrombosis after endeavor drug-eluting stent (des)placement in an all comers population with a broad range of bleeding and thrombosis risk. educate will further analyze the current practice of clinicians regarding temporary cessation of antiplatelet therapy and its association with clinical outcomes. in addition, patients included in this broad endeavor registry will also be contributed to the dapt native study population for analysis of 12 vs 30 months duration of dual antiplatelet therapy.

Eligibility criteria:
enrollment inclusion criteria * patient is older than 18 years. * the patient or patient's legal representative has consented to participate and has authorized the collection and release of his medical information by signing the "subject informed consent form". * patients undergoing percutaneous intervention with endeavor stent deployment (or has within 24 hours). * the patient is willing and able to cooperate with study procedures and required follow up visits. enrollment exclusion criteria * index procedure stent placement with stent diameter \ 3.5 mm. * pregnant women. * current medical condition with a life expectancy of less than 3 years. * the patient is currently participating in another investigational device or drug study that clinically interferes with the educate study. the patient may only be enrolled in the educate study once. * patients with hypersensitivity or allergies to one of the drugs or components indicated in the instructions for use. * patients in whom anti-platelet and/or anticoagulation therapy is contraindicated. * patients treated with any stent other than the endeavor stent during the index procedure. randomization inclusion criteria at 12 months * subject is "12 month clear". * subjects without known contraindication to dual antiplatelet therapy for at least 18 months after randomization. randomization exclusion criteria at 12 months * pregnant women. * subject switched thienopyridine type or dose within 6 months prior to randomization. * planned surgery necessitating discontinuation of antiplatelet therapy within the 18 months following randomization. * percutaneous coronary intervention or cardiac surgery between 6 weeks post index procedure and randomization. * planned surgery necessitating discontinuation of antiplatelet therapy within the 21 months following randomization. * current medical condition with a life expectancy of less than 3 years. * subjects on warfarin or similar anticoagulant therapy.

Keywords: heart disease cardiovascular disease platelet aggregation inhibitors dual antiplatelet therapy clopidogrel prasugrel vascular disease myocardial ischemia
brain networks implicated in lifelong premature ejaculation patients

Conditions: Premature Ejaculation; Sexual Dysfunction

Summary: using brain mapping and cognitive erps, the investigatos have searched for a brain networks involved during inhibitory control in lifelong premature ejaculation (lpe) participants. the investigators have designed a clinical trial comparing placebo with tdcs and blacebo group against dapoxetine, studying the effects on lpe, as well as side effects and their medium and long-term duration.

lifelong premature ejaculation (lpe) is a very common male sexual dysfunction like erectile dysfunction. it produces great distress to sexual harmony and even fertility. previous neurophysiology studies revealed an ejaculation-related control mechanism in the brain: left inferior frontal gyrus (ifg) activation during successful inhibition. if we use the left ifg as a seed, participants showed weaker resting-state functional connectivity (fc) activity, between the seed and two areas (left dentate nucleus (dn) and right frontal pole) compared with controls. the main goal is to compare whether the brain biomarker only exists in participants with lpd and how it responds to treatment with dapoxetine and with tdcs against the ifg networks and ldn, measuring the connectivity changes in these brain networks and fc.

Eligibility criteria:
inclusion criteria: * to be over 18 years old and less than 70 years * best-practice diagnosed longlife premature ejaculation * diagnosed since at least one years prior to enrollment. * no use drugs or medicines exclusion criteria: * serious visual and hearing loss * brain injury following cranial trauma * other neurological disorders like parkinson, me, headache, etc. * birth trauma * mental retardation

Keywords: brain mapping eeg erp tdcs trns dapoxetine lifelong premature ejaculation central inhibitory network function inferior frontal gyrus dentate nucleus right frontal pole resting state networks funtional connectivity
comparison of dbs targets in obsessive-compulsive disorder

Conditions: Obsessive-Compulsive Disorder

Summary: deep brain stimulation (dbs) has been proposed for severe and resistant obsessive-compulsive disorder. this electrical stimulation has been tested on, and shown to be effective at, different targets (subthalamic nucleus, caudate nucleus \& nucleus accumbens). however, the efficacies of each target have never been compared directly. this protocol aims to do so, with the hypothesis that subthalamic (stn) stimulation will be more efficacious.

deep brain stimulation has been proposed for severe and resistant obsessive-compulsive disorder (ocd). this electrical stimulation has been tested on, and shown to be effective at, different targets (subthalamic nucleus, caudate nucleus \& nucleus accumbens). however, the efficacies of each target have never been compared directly. therefore, bilateral subthalamic and caudate electrodes will be implanted in severe ocd patients. efficacy of stimulation at the different targets will be assessed using a double-blind randomised crossover design.

Eligibility criteria:
inclusion criteria : * age 18 - 60 * ocd according to dsm iv, at least 5 years since diagnosis * severe ocd responsible for a clinically significant and objective alteration of psychosocial functioning and suffering: ybocs score\>25, cgi score \>= 4 and egf score \<= 40 * resistance of ocd to at least 3 antidepressants from the serotonin reuptake inhibitors category, including clomipramine, given for at least 12 weeks with doses of at least 80mg/d for fluoxetine, 300mg/d for fluvoxamine, 200mg/d for sertraline, 60mg/d for paroxetine and citalopram, 250mg/d for clomipramine). plus resistance to each of these 3 antidepressant associated first to risperidone or pimozide for a month then to lithium carbonate, clonazepam, buspirone or pindolol for a month * resistance to at least 2 behavioural and cognitive therapies conducted by as many different specialists, following validated protocols (e.g. exposition and prevention of response) * oral and written knowledge of french * social security coverage * written consent of the patient after clear description of the study exclusion criteria : * cognitive alteration with pm38 score \< iq85 * other axis 1 disorder according to dsm iv, excepted, global anxiety disorder, social phobia, nicotine dependance, and antecedent of major depressive episodes * suicidal risk \>=2 on item 10 of madrs (montgomery asberg depression rating scale) * personality disorder (axis 2 of dsm iv assessed using the scid ii) * contra indication to mri, abnormal brain mri, other severe intercurrent disease * fertile woman without adequate contraception * pregnancy * forced psychiatric hospitalisation * any kind of legal protection

Keywords: obsessive-compulsive disorder deep brain stimulation subthalamic nucleus caudate nucleus nucleus accumbens
a cohort of acute, ischemic and rare neuropathies

Conditions: Ischemic Neuropathy; Rare Neuropathy

Summary: neuropathies are defined as the clinical, electrical, biological and histological manifestations of peripheral neuron damage. they represent a heterogeneous group of disorders and are responsible for disabling sensory and motor disorders. their diagnosis is based on a set of clinical arguments confirmed by the electromyogram. this allows to specify the site of the damage, its severity, and to follow the evolution of the disease. to date, the diagnosis of peripheral nerve injury secondary to occlusion of arterial trunks is rarely evoked; its clinical, electromyographic and prognostic characteristics are poorly known. indeed, the rare cases reported in the literature are from vascular specialties, with little data on neurological symptoms, neurophysiological diagnostic elements and prognosis. however, these unrecognized and underdiagnosed neuropathies are sometimes indicative of severe vascular damage for which urgent management is necessary. neurological symptoms should then be treated as warning signs and the correct recognition of the early ischemic vascular etiology may lead to an optimized medical management. the objectives of this study will be to describe the clinical presentation of these neuropathies, to discuss their electrophysiological diagnostic characteristics, to compare the demographic data with those from the literature, and to evaluate the functional prognosis of these attacks. a better knowledge of this rare etiology of neuropathy would allow to better inform the patients and to optimize the diagnostic and therapeutic management.


Eligibility criteria:
inclusion criteria: * patient whose age ≥ 18 years * patient hospitalized or seen in neurophysiological consultation/exploration in the neurology department within the groupe hospitalier paris saint-joseph * diagnosis of acute or subacute peripheral nerve ischemia * french speaking patient exclusion criteria: * patient with impaired comprehension making it impossible to understand the protocol * patient under guardianship or curatorship * patient under court protection * patient deprived of liberty * patient or relative who objects to the use of his/her data
clinical utility of capnography in the pacu( post-anaesthesia care unit)

Conditions: Respiratory Depression

Summary: multi-center observational trial with study device blinded in order to assess in parallel standard monitoring and intervention practices related to management of respiratory compromise in the post-anaesthesia care unit (pacu)

all study device information is blinded to medical staff but the study coordinator will have full access to device measurements, alarms, notification and events via a local wi-fi hub sent to a portable tablet. the tablet case report form (crf) will allow all observation be inserted with a time stamp on the electronic device data. in addition, all electronic data will be collected from the bedside monitor.

Eligibility criteria:
inclusion criteria: 1. adult ≥ 18 years of age 2. asa score ii - iv (american society of anaesthesiologists score) 3. patients booked for a surgical procedure requiring general anesthesia care 4. expected duration of general anesthesia to be \> 1.5 hours 5. expected to receive intraoperative opioids 6. expected to be transferred to the pacu from the operating room 7. patients with an expected duration in the pacu ≥ 45 minutes 8. expected to be transferred from the pacu to an in-patient setting exclusion criteria: 1. patients expected to be discharged from the hospital when discharged from the pacu 2. subjects who will have oral/nasal surgery that may prevent wearing an oral/nasal capnography sampling filterline. 3. subjects with a history of severe contact allergies that may cause a reaction to standard adhesive materials found in pulse oximetry sensors. 4. patients with skin lesions or physical deformities that would prevent the application of finger sensors for optimal performance. 5. a female known to be pregnant.

Keywords: post-operative respiratory distress
comparison of different massage techniques plus conservative applications in low back pain

Conditions: Low Back Pain

Summary: the aim of this study is to compare of different massage techniques plus conservative aplications in low back pain treatment.


Eligibility criteria:
inclusion criteria: * having non specific low back pain without any relevant ongoing pathologies such as disc prolapse, spondylolisthesis, fractures, tumor, osteoporosis, infection * willing to participate exclusion criteria: * spinal surgery in the past 6 months or having to undergo surgery or invasive examinations during the study; * neurological disease; * psychiatric disease; * serious chronic disease that could interfere with the outcomes (e.g., cardiovascular disease, epilepsy, rheumatoid arthritis), * pregnant during the study
the relationship between aortic pulse wave, aortic calcification and peripheral artery occlusion disease in peritoneal dialysis patients

Conditions: End-stage Renal Disease; Peritoneal Dialysis; Aortic Calcification; Peripheral Artery Occlusion; Cardiovascular Disease

Summary: cardiovascular disease (cvd) is the leading cause of mortality in patients with end-stage renal disease (esrd), which means that it is important to find out risk factors of cvd in order to prevent or treat it. in recent years, there has been more and more recognition of a very high prevalence of cv calcification in the esrd population. many observational cohort studies have shown that cv calcification in these patients can predict mortality, cv mortality and morbidity. electrolyte imbalance is easily found in the esrd patients which may result in vessel calcification. calcification leads to arterial stenosis and increasing arterial stiffness and then heart afterload, both contribute to the development of cvd. besides, metabolic syndrome, insulin resistance, and dyslipidemia pave the way for a chronic, immune-mediated vascular inflammation and cardiovascular disease. these factors are prevalent in esrd patients, which would also cause arterial stiffness. arterial stiffness and stenosis would increase the risk of cv events and mortality. aortic pulse wave velocity is strongly associated with the presence and extent of atherosclerosis and constitutes a forceful marker and predictor of cardiovascular risk. at the same time, high prevalence of peripheral artery occlusion disease (paod) should also be found while arterial stiffness and stenosis, which would increase the condition of infection and gangrene. thus, life safety and quality would be influenced severely and early detection might prevent future amputation. as compared with hd or pre-dialysis patients, uremic patients treated with pd have a higher risk for metabolic syndrome. therefore, more studies to evaluate the condition of arterial stiffness and paod, especially in pd patients, are needed for future management and preventions of cv related morbidity and mortality.


Eligibility criteria:
inclusion criteria: 1. patients at national taiwan university hospital (ntuh) 2. patients who have received pd more than 3 months 3. patients who sign the informed consents exclusion criteria: 1. patients who refuse to sign informed consents 2. patients who refuse to draw additional blood for research

Keywords: calcification aortic pulse wave velocity peripheral artery occlusion disease peritoneal dialysis metabolic syndrome
safety study of a bioresorbable coronary stent

Conditions: Myocardial Ischemia; Coronary Artery Stenosis; Coronary Disease; Coronary Artery Disease; Coronary Restenosis; Cardiovascular Disease

Summary: to evaluate the safety of a new bioresorbable (non-permanent) stent platform in native coronary arteries.

today, coronary artery disease is often treated by placing a metal stent inside the vessel that serves as a permanent scaffold. however, it is hypothesized that the stent is no longer needed once the artery has healed. this study will evaluate the safety of a bioresorbable (non-permanent) stent for the treatment of coronary artery disease. the stent is designed to restore blood flow to the artery which allows the artery to remodel (heal), and then resorb from the body. the stent supports the vessel during the critical 90-day healing process, and then gradually resorbs and is cleared from the body.

Eligibility criteria:
inclusion criteria: * evidence of myocardial ischemia or a positive functional study. * normal ck-mb. * target lesion must be located in a native coronary artery where target vessel diameter is ≥ 2.9 mm and ≤ 3.3 mm and target lesion length is ≤ 12 mm, both assessed by on-line qca and ivus * target lesion must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and \< 100% with a timi flow of ≥ 2. * staged procedures are allowed in non-target vessels \>24 hours before or \> 30 days after reva stent implantation exclusion criteria: * a myocardial infarction (ck-mb or troponin \> 3 times normal) within 72 hours of the procedure, has signs or symptoms of an ongoing myocardial infarction or has any visible thrombus * unprotected left main coronary disease with \>50% stenosis * the target vessel is totally occluded (timi flow 0 to 1) * target lesion involves a bifurcation (a lesion with a side branch \>2.0 mm in diameter containing a \>50% stenosis) * target lesion is located within a segment supplied by distal graft * target lesion has possible or definite thrombus