Kornimate/medical-research-clean huggingface dataset:
fantom encore sirolimus-eluting bioresorbable scaffold for treatment of de-novo cad: the encore-i study

Conditions: Percutaneous Coronary Intervention; Myocardial Revascularization; Tomography, Optical Coherence

Summary: prospective, multicentre, non-randomized, investigator-initiated study aiming to assess the safety and efficacy of the fantom encore sirolimus-eluting bioresorbable scaffold (brs).

up to 50 consecutive participants with de-novo non-complex obstructive coronary lesions and non-st elevation acute coronay syndromes or stable angina pectoris will be included in the netherlands and belgium. device performance and behaviour will be assessed by angiography and optical coherence tomography at the index procedure and at 13 months follow-up.

Eligibility criteria:
inclusion criteria: * 18 years or older * stable angina, unstable angina or documented silent ischemia (invasive or non-invasive test) or non-st segment elevation acute myocardial infarction. * de-novo non-complex coronary obstructive lesions (\>50% stenosis as assessed by quantitative coronary analysis (qca)) * the patient is willing and able to comply with the specified follow-up evaluations. * reference vessel diameter (rvd) ≥ 2.5 mm and ≤ 4.0 mm by qca. * during pre-dilatation, the pre-dilatation balloon is uniformly expanded to the full intended diameter. * target segment suitable for oct imaging exclusion criteria: * target vessel with a distal thrombolysis in myocardial infarction (timi) flow 0 or 1. * target lesion located within 5.0 mm of vessel origin. * lesion type acc/aha c. * heavily calcified lesion * severe tortuosity * target lesion is located in or supplied by an arterial or venous bypass graft. * target lesion requires treatment with a device other than the pre-dilatation balloon prior to scaffold placement (including but not limited to directional coronary atherectomy, excimer laser, rotational atherectomy, etc.). * unsuccessful pre-dilatation, defined as a residual diameter stenosis ≥ 30%, assessed by qca. * planned future revascularization of non-culprit lesions. * presence of another device (stent or scaffold) located within the same segment (5mm from the target lesion borders). * patient is currently participating in another study with an investigational device or an investigational drug and has not completed the entire follow-up period. * impaired renal function (egfr \<30ml/min). * patient has a contraindication for the use of double antiplatelet therapy for at least 12 months. * pregnant or breastfeeding patients. * patient has a known allergy to contrast medium, sirolimus, tyrosine-derived polycarbonate or other structurally related compounds. * patient is receiving chronic oral or intravenous immunosuppressive therapy or has known life-limiting immunosuppressive or autoimmune disease (diabetes mellitus is not an exclusion criteria). * patient has a co-morbidity, which reduces life expectancy to ≤ 24 months, or social-economic factors making compliance with the study requirements difficult.

Keywords: bioresorbable scaffold percutaneous coronary intervention oct
icbt for pain-predominant fgids in children and adolescents: an implementation study.

Conditions: Functional Gastrointestinal Disorders; Irritable Bowel Syndrome; Dyspepsia; Functional Abdominal Pain

Summary: this open trial aims to evaluate feasibility and preliminary effectiveness of an internet-delivered cbt-program for children and adolescents with functional gastrointestinal disorders when implemented in regular care.

pain predominant functional gastrointestinal disorders (p-fgids) are common in children and adolescents and associated with impaired quality of life. our research group have previously in a series of efficacy-studies shown that internet-delivered exposure-based cbt leads to reduced symptoms and increased quality of life in children and adolescents with p-fgids. there is therefore reason to investigate how the treatment should be disseminated in regular care. this open trial aim to evaluate feasibility and preliminary treatment effects in regular care of the internet-delivered cbt-program for children and adolescents with p-fgids. method: open trial with a pretest-posttest-design and no control group. the internet-delivered cbt-program is 10 week long and include weekly therapist support, consisting of online messages and telephone calls. assessment points are baseline, weekly during treatment, post-treatment and follow-up at 3 months and 6 months after treatment completion. analysis: effect sizes and within-group differences will be calculated in an intent-to-treat analysis using cohens' d and student's t-test.

Eligibility criteria:
inclusion criteria: * age 8-17 at date of inclusion. * fulfilling rome iv-criteria for irritable bowel syndrome, functional dyspepsia or functional abdominal pain with a written statement from patient's physician confirming a diagnosis. * stable psychotropic medication for at least 1 month. exclusion criteria: * concurrent serious medical conditions. * a psychiatric diagnosis, judged to be a more important treatment target than the abdominal pain. * on-going structured psychological treatment. * absence from school exceeding an average of 2 days a week the last month is a cause for exclusion since high school absence demands more intensive interventions than can be offered in icbt. * on-going abuse or severe parental psychiatric illness in the family. * since treatment format assumes normal reading and writing skills, pronounced language skill deficits and learning difficulties lead to exclusion from the study. * lack of regular internet-access.
rate of venous thrombosis in acutely ill patients hospitalized in internal medicine wards

Conditions: Venous Thromboembolism; Deep Venous Thrombosis

Summary: after reports from observational studies suggesting an association between acutely ill medical patients and venous thromboembolism (vte), interventional trials with anticoagulants drugs have demonstrated a significant reduction of vte during and immediately after hospitalisation. although several guidelines suggest the clinical relevance of reducing this outcome, there is a low tendency to use anticoagulants in patients hospitalised for acute medical illness. this observational multicentre study wants to evaluate the incidence of venous thrombo-embolism in acutely ill patients hospitalized in internal medicine wards.

epidemiological studies have provided evidence of a high rate of thromboembolism in patients hospitalised in medical wards. based on this, several clinical trials with anticoagulants including low-molecular-weight heparin (lmwh) and fondaparinux have been performed in patients hospitalised for acute medical illness to prevent thromboembolism. interventional trials consistently showed that prophylaxis with anticoagulants reduces the risk of composite endpoints of deep venous thrombosis (dvt), pulmonary embolism (pe) and dvt-related death. these results prompted recommendation to the use anticoagulant prophylaxis in patients hospitalised for acute medical illness, but, despite this, there is a widespread underuse of anticoagulant prophylaxis in the medical wards of hospitals. this observational multicentre study wants to evaluate the incidence of venous thrombo-embolism in acutely ill patients hospitalized in internal medicine wards.

Eligibility criteria:
inclusion criteria: * pneumonia * heart failure * chronic obstructive pulmonary disease * kidney failure * syncope * atrial fibrillation * urinary tract infection * anemia * arthritis * diabetic ketoacidosis * unstable angina * asthma * cirrhosis exclusion criteria: * treatment with vitamin k inhibitors * surgical interventions * deep venous thrombosis * pulmonary embolism
pparγ agonist treatment for cocaine dependence

Conditions: Cocaine Use Disorder; Alcohol Use Disorder

Summary: the purpose of this research study is to determine whether a medication called pioglitazone (trade name actos) can reduce behavioral problems associated with cocaine use, improve brain structural changes associated with cocaine use and reduce cocaine craving and drug use in cocaine dependent patients.


Eligibility criteria:
inclusion criteria: * dsm-iv criteria for cocaine dependence * at least one cocaine positive urine during screening * female subjects: a negative pregnancy test * be in acceptable health on the basis of interview, medical history and physical exam * be able to understand the consent form and provide written informed consent * be able to provide the names of at least 2 persons who can generally locate their whereabouts. exclusion criteria: * current diagnostic and statistical manual of mental disorders (dsm)-iv diagnosis of any psychoactive substance dependence other than cocaine marijuana, alcohol, or nicotine * any serious medical or psychiatric illness and/or clinically significant abnormal laboratory value, which in the judgment of the principal investigator or his/her designee would make study participation unsafe, or would make treatment compliance difficult or put the study staff at undue risk * significant current suicidal or homicidal ideation * medical conditions contraindicating pioglitazone pharmacotherapy (e.g., congestive heart failure as determined by framingham criteria, clinically significant edema, clinically significant liver disease, hypoglycemia, diabetes, history of bladder cancer) * taking medications known to have significant drug interactions with the study medication (cyp2c8 inhibitors or inducers, antihyperglycemic medications) * currently being treated for substance misuse with medication * conditions of probation or parole requiring reports of drug use to officers of the court * impending incarceration * pregnant or planning to become pregnant during the course of the trial or nursing for female patients * inability to read, write, or speak english (many of the research instruments in this study only exist in english) * having plans to leave the immediate geographical area within 3 months * unwillingness to sign a written informed consent form * unwillingness to use a barrier method of birth control during the study for female patients * history of pacemaker or metal implants or welding or metal work without protective eyewear (for risk of mri scans).
popliteal sciatic nerve block for diabetic foot surgeries

Conditions: Diabetic Patient

Summary: popliteal sciatic nerve block is a regional technique that provides safe and reliable perioperative anesthesia and analgesia of lower leg and foot used in diabetic patients. different additives have been used with local anaesthetics to achieve dense and prolonged block. magnesium sulfate possesses analgesic properties owing to its effect on nmda receptors.


Eligibility criteria:
inclusion criteria: * (asa) ii or iii * scheduled for diabetic foot surgeries. exclusion criteria: * patients who refused the anaesthetic technique, * whose bmi ≥ 35 kg/ m2, * unable to properly describe postoperative pain to investigator (dementia, delirium, psychiatric and neurological disorders), * patients with coagulopathy, skin infection at the site of injection, * preoperative use of opioid or non-steroidal anti-inflammatory drugs, * allergy or contraindication to studied medication
diagnostic performance of 3t mri t2 mapping technique in chondro-labral pathology of the hip, correlated with intraoperative arthroscopic findings: interventional diagnostic technique validation study (hpi mri 3t)

Conditions: Hip Injuries and Disorders; Hip Arthrosis

Summary: the goal of this observational study is to evaluate the diagnostic performance of the t2 mapping technique of the following 4 mri scans in detecting hip chondro-labral lesions in comparison with intraoperative arthroscopic findings: 1) basal 3t mri with t2 mapping technique, 2) 3t mri with t2 mapping technique and limb traction; 3) 3t arthro-mri with t2 mapping technique; 4) 3t arthro-mri with t2 mapping technique and limb traction.

this study will evaluate the role of t2 mapping technique in the diagnosis of chondral and labral lesions of the hip. in particular, the following 4 types of mri scan will be compared to each other and with intraoperative arthroscopic findings: * basal 3t mri without contrast * 3t mri with limb traction * arthro-rm 3t after intrarticular gadolinium and local anesthetic injection under ultrasound control * arthro-rm 3t after intrarticular gadolinium and local anesthetic injection under ultrasound control + limb traction. the primary endpoint is to: * assess the diagnostic performance of baseline 3t mri with t2 mapping technique in terms of sensitivity, specificity, ppv, and npv in the diagnosis of hip labral lesions, according to philippon's classification, and chondral lesions according to modified outerbridge classification, * compare the diagnostic performance between all the mentioned above scans. the secondary endpoint is to evaluate the sensitivity, specificity, ppv and npv of 3t mri with longitudinal traction of the lower limb in detecting, localizing and grading chondral lesions of the coxo-femoral joint. the present study will involve 30 young patients with coxalgia non responding to conservative treatment and referable to a chondro-labrum injury based on clinical and imaging examinations. patients will undergo rm diagnostic protocol and will receive hip arthroscopy within the next 6 months.

Eligibility criteria:
inclusion criteria: * patients with symptomatic localized chondro-labral lesion requiring arthroscopic treatment * consent to conduct the study * bmi\<30 exclusion criteria: * patients unable to read or understand the patient information and consent forms; * previous surgery on the same hip; * coxarthrosis ≥ 2 according to tonnis; * acetabulum and/or proximal femur fractures; * presence of psychological disorders, which might interfere with their ability to undergo the 4 mri examinations; * known sensitivity to gadolinium; * bmi ≥ 30; * current infections; * tumors; * metabolic disorders; * presence of peripheral neurological disorders such as pudendal neuralgia, peroneal neuralgia, neuralgia sciatica that traction may risk worsening.

Keywords: 3t mri labral and chondral lesions hip arthroscopy
effect of high altitude exposure, acclimatization and re-exposure on nocturnal breathing pattern in lowlanders

Conditions: Effect of High Altitude

Summary: prospective interventional trial in lowlanders evaluating the effect of acute exposure, acclimatization and re-exposure of high altitude on nocturnal breathing pattern.

respiratory polygraphies will be performed in santiago de chile, 520 m, over the course of 3 days. participants will then travel by commercial airline (5 h flight) and by bus (3 h ride) to the alma base camp located at 2900 m near san pedro de atacama, northern chile. participants will stay there for the next 7 nights and respiratory polygraphies will be performed on night 1 and 6. they will be spend the days (6-8 h daily) at the telescope station at 5050 m while undergoing physiological testing. daily transports from 2900 to 5050 m will be by car (1 h ride, one way). after the first 8 day altitude sojourn participants will return to the santiago area (520 m) for a 6 day recovery period. a second altitude sojourn with an identical schedule as the one described above and a final low altitude stay of 3 days will follow.

Eligibility criteria:
inclusion criteria: * born, raised and currently living \<800m * no overnight stay at altitudes \>1500 m 4 weeks before the study exclusion criteria: * previous altitude intolerance to altitude \<3000 m * pregnancy * health impairment, which requires regular treatment

Keywords: altitude nocturnal breathing pattern
validation of hand held dynamometer for assessment of lower limb muscle strength in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: evaluate a method of testing the strength of five key lower limb muscle groups using a hand-held strength gauge (dynamometer).

purpose of this study is to assess the intra-rater and inter-rater reliability of a hand-held dynamometer (hhd) in the assessment of lower limb strength in patients with multiple sclerosis. also to establish a standardized strength testing procedure for key lower limb muscle groups using a hhd fo research and clinical purposes in multiple sclerosis.

Eligibility criteria:
inclusion criteria: * stable patients with clinically definite multiple sclerosis * no multiple sclerosis exacerbation 30 days prior to screening * no change in disease modifying therapy for 30 day prior to screening exclusion criteria: * inflammatory myopathy * endocarditis, pericarditis o rother unstable heart disease * cardiac surgery or myocardial infarction in the last 3 months * decompensated congestive heart failure * severe aortic stenosis * severe pulmonary hypertension * pulmonary embolus or infarction in the last 6 months * uncontrolled hypertension by history or by screening or baseline diastolic blood pressure \>170 or systolic blood pressure \>105 * concomitant neurodegenerative neurological disease such as amyotrophic lateral sclerosis (als) parkinsons or hemiplegic stroke * females who are pregnant * cognitive deficits that would interfere with the subjects's ability to give informed consent or preform study testing * painful orthopedic condition affecting the lower limbs * any other serious and/or unstable medical condition
a novel method to assess the cornea biomechanical properties with schiotz tonometer

Conditions: Keratoconus

Summary: this study aims to use schiotz tonometer to evaluate the corneal biomechanical properties. the administration of schiotz tonometer is according to the routine protocol which is use to measure intra-ocular pressure. the results obtained from schiotz tonometer will be compared with results obtained from ora and/or corvis.

schiotz tonometer, since it firstly be developed more than 100 years ago by hjalmar schiotz, has been regarded as a classical method to evaluate intraocular pressure (iop). in present study, we aims to measure the corneal biomechanical properties with schiotz tonometer and elucidate the clinical significance of this novel measurement. the corneal biomechanical property was calculated with subtracting the value displayed under loaded weight 5.5g from that under loaded weight 7.5g. we named the corneal biomechanical properties obtained with schiotz tonometer as mulee factor, and the formulation is mulee factor=value under loaded weight 7.5g (value 7.5g)-value under loaded weight 5.5g (value 5.5g).

Eligibility criteria:
inclusion criteria: * people without the disease mentioned in exclusion criteria part. exclusion criteria: * patients with ocular diseases including keratitis, conjunctivitis, history of chronic eye/systemic diseases except myopia and keratoconus, history of ocular surgery except lasik, pregnant or lactating females.
online cognitive behavioral therapy (cbt) workbook

Conditions: Low Back Pain

Summary: this research will evaluate the efficacy of a new online self- help intervention, the wellness workbook, for individuals with chronic low back pain (clbp). participants will be randomly assigned to use the wellness workbook or alternative self-help materials and assessed at baseline, post-intervention (10 weeks) and at follow-up (18 weeks). outcome measures include pain-related disability and pain severity.

this research will evaluate the efficacy of a new online self- help intervention, the wellness workbook, for individuals with chronic low back pain (clbp). the wellness workbook is an interactive online intervention that uses evidence-based cognitive behavioral therapy (cbt) strategies, behavioral activation and mindfulness training to increase chronic pain patients' quality of life. 198 patients with chronic low back pain will be randomly assigned to use the wellness workbook or alternative self-help materials for 10 weeks. participants will be assessed at baseline, post-intervention (10 weeks) and at follow-up (18 weeks). outcome measures include pain-related disability, pain severity, physical activity, mindfulness and pain-related attitudes and beliefs.

Eligibility criteria:
inclusion criteria: * currently experiencing chronic non-cancer pain in the lower back exclusion criteria: * has a health diagnosis that would prevent him/her from participating fully in the program (e.g., is receiving treatment for cancer) * does not have regular internet access

Keywords: chronic low back pain cognitive behavioral pain management coping mindfulness physical activity back pain lower back chronic
investigation of critically ill patients with newly diagnosed diabetes

Conditions: Diabetes Mellitus

Summary: the purpose of this study is to investigate the clinical outcomes and glucose control metrics of critically ill patients with previously undiagnosed diabetes compared to those with known diabetes at the time of admission to the intensive care unit (icu).

this case control study compares previously undiagnosed diabetic patients (defined as hba1c \> 6.5% and no history of diabetes), to those with known diabetes, using 1:1 matching. patients met inclusion criteria by having hba1c available on icu admission and at least four blood glucose tests during their icu stay. primary outcomes included icu length of stay and inpatient mortality. secondary outcomes included glucose metrics: mean blood glucose, coefficient of variation and percentage of patients who developed hypoglycemia.

Eligibility criteria:
inclusion criteria:20 * patients admitted between 9/14/2011 and 11/30/19 with hba1c available on admission and at least four documented blood glucose tests during their icu stay. exclusion criteria: * patients admitted for diabetic ketoacidosis. * patients admitted to the icu following cardiovascular surgery.

Keywords: diabetes mellitus glucose metrics outcome evaluation intensive care unit
osteopathy and obstructive sleep apnea syndrome ii

Conditions: Obstructive Sleep Apnea Syndrome

Summary: the main objective is to evaluate an osteopathic compression of pterygopalatine node in healthy subjects and patients suffering from obstructive apnea syndrome (osa).

osteopathic compression will be compared to a sham manoeuvre in a cross over design on apnea hypopnea index, pharyngeal collapsibility and symptoms in patients suffering from osa, and on symptoms and pharyngeal collapsibility in healthy subjects.

Eligibility criteria:
obstructive sleep apnea syndrome patient: inclusion criteria : * male or female aged 18 years or more * obstructive sleep apnea syndrome with apnea/hypopnea index \> or = 15/hour * body mass index \<40kg/m2 exclusion criteria : * pregnant or lactating women * participating to another trial * acute infectious disease of upper respiratory airway tract at inclusion * complete nasal obstruction * facial neuralgia at inclusion * patients not able to stop treatment for osa within one week before each visit * allergy to latex * dental extraction within 15 days before inclusion * pharyngeal surgery in the past * incapable adult * patients treated with selective serotonin reuptake inhibitor healthy volunteers inclusion criteria : * male or female aged ≥18 and ≤ 40 years * no obstructive sleep apnea syndrome * body mass index \<30kg/m2 * no chronicle respiratory, neurological, cardiac or able to deteriorate sleep quality disease * low obstructive sleep apnea syndrome probability measured with berlin scale exclusion criteria : * pregnant or lactating women * participating to another trial * acute infectious disease of upper respiratory airway tract at inclusion * complete nasal obstruction * facial neuralgia at inclusion * allergy to latex * dental extraction within 15 days before inclusion * pharyngeal surgery in the past * incapable adult * patients treated background treatment

Keywords: osteopathy sleep apnea syndromes obstructive sleep apnea pcrit polysomnography