Kornimate/medical-research-clean huggingface dataset:
assessment of the impact of tip score on thromboprophylaxis in patients with non-surgical lower leg trauma.

Conditions: Lower Limb Injury; Pulmonary Embolism; Venous Thromboses

Summary: traumatic lesions are the leading causes of admission to the emergency center (39%), isolated non-surgical lower limbs trauma are in the foreground. two recent meta-analyzes suggest the value of low molecular weight heparins (lmwh) which would reduce symptomatic thromboembolism events (te) in patients with lower limb trauma. however, many recent studies conclude to the need of stratifying the te risk according to the patient and the nature of his trauma to obtain an individualized therapeutic decision. the retrospectively established l-trip (cast) score allows stratification of the risk without taking into account the type of trauma. the tip score (trauma, immobilization and patient) was established by consensus of international experts via the delphi method. we suggest that the application of the tip score to rationalize indications of thromboprophylaxis in patients with isolated non-surgical trauma of a lower limb should reduce the rate of anticoagulation prescription without increasing the risk of symptomatic thromboembolic complications with a direct benefit for patients and medico-economic for the society.

all patients admitted to the emergency departments for a nonsurgical isolated lower limb trauma necessitating rigid or semi-rigid immobilization, will be assessed for possible participation. after the physicians had obtained the no-opposition of the patient, they will fill a questionnaire. this questionnaire includes the treatment chosen by the physician, the type of trauma, the type of immobilization chosen, and the patient's thromboembolic risk factors in order to calculate the tip and l-trip (cast) scores retrospectively. phone follow-up will occur within 3 months to gather clinical event data (any signs of vte, any bleeding events).

Eligibility criteria:
inclusion criteria: * consultation in one of the emergency departments of the participating centres * isolated unilateral lower limb injury not requiring surgery * lower limb rigid or semi-rigid orthopedic immobilization (i.e. brace of plaster cast) for at least 5 days. * full insurance cover exclusion criteria: * any anticoagulant or antiplatelet treatment prior to trauma * contra-indication to fondaparinux or lmwh * factors rendering 3-month follow-up impossible * imprisonment * inability to provide informed consent

Keywords: thrombophylaxis deep venous thrombosis pulmonary embolism lower leg trauma
the efficacy of heparin-boned viabahn endoprosthesis and paclitaxel-coated balloons for complex femoropopliteal lesions

Conditions: Peripheral Arterial Disease

Summary: the purpose of this study is to evaluate the effectiveness of the viabahn endoprosthesis for treating long femoropopliteal lesions (stenosis ≥ 25cm, occlusion ≥ 15cm) or recurrent in-stent restenosis compared to drug-coated balloons (dcb) with or without a bailout bare nitinol stent.

this is a multicenter, prospective, 1:1 randomized clinical trial with clinical and image follow-up for two years post-procedure. approximately 60 subjects will be enrolled and randomized into a viabahn preferred group (study arm) or drug-coated balloons (dcb) group (control arm); each group will include 30 patients. all enrolled patients will be followed up for 12 months to assess the incidence of restenosis by duplex ultrasound and major adverse events. follow-up visits occur at 12 and 24 months, as well as telephone visits after 1, 6, 9 and 24 months.

Eligibility criteria:
inclusion criteria: 1. the patient presented a score from 2 to 5 following rutherford classification. 2. the patient is willing to comply with specified follow-up evaluations at the specified times. 3. the patient is ≥ 18 years old. 4. patient understands the nature of the procedure and provides written informed consent before enrolment in the study 5. the patient has a projected life expectancy of at least 24 months 6. before enrolment, the guidewire has crossed the target lesion 7. subject has a de novo or restenotic lesion with ≥ 70% stenosis in femoropopliteal artery, and for de novo lesion, the total lesion length ≥ 25cm, or chronic total occlusion (cto) length ≥15cm. 8. there is angiographic evidence of patent infrageniculate popliteal artery and at least one distal runoff to the foot. 9. origin and proximal 1 cm of superficial femoral artery (sfa) are patent. 10. reference vessel diameter (rvd) ≥ 4 mm by visual estimation. exclusion criteria: 1. previous bypass surgery or stenting in the target vessel 2. patients who exhibit acute intraluminal thrombus at the target lesion vessel 3. patients with known hypersensitivity or contraindication to any of the following medications: nitinol-titanium, antiplatelet therapy, anticoagulants, or thrombolytics therapy 4. pregnant women or female patients with potential childbearing 5. use of thrombectomy, atherectomy, or laser devices during the procedure 6. untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion) 7. the patient is currently participating in another investigational drug or device study that interferes with the study 8. significant renal dysfunction (serum creatinine \>3.0mg/dl) 9. patient with known allergy to contrast media 10. significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy. 11. femoral or popliteal aneurysm. 12. current peritoneal or hemodialysis.

Keywords: viabahn endoprosthesis drug-coated balloon
evaluation of ion releasing hybrid restorative material

Conditions: Dental Caries

Summary: esthetic and mechanical evaluation of calcium and phosphate releasing hybrid restorative material and fluoride releasing hybrid restorative material versus the conventional nanofilled resin composite in proximal carious lesions over 1 year follow-up according to the usphs criteria.

3 groups of 45 patients will receive class ii restorations by using calcium and phosphate releasing hybrid restorative material (activa presto), fluoride releasing hybrid restorative material (giomer), and conventional nanofilled resin composite. then these restorations evaluated at 24 hours after placement, 1 month, 3 months, 6 months and 12 months according the modified usphs criteria in terms of fracture, marginal adaptation, retention, anatomic form, marginal discoloration, surface texture, and color match.

Eligibility criteria:
inclusion criteria: * patient-related criteria: * patients consulting in one of the outpatient clinics listed above. * patients can tolerate necessary restorative procedures. * provide informed consent. * patients accept the one year follow-up period. * patients are within middle age group (25-40years). * cooperative patients. * patients don't have any medically compromised conditions. tooth related criteria: * teeth with primary proximal carious lesions in posterior teeth with no pulpal involvement. * teeth should have contact with the adjacent teeth. * teeth are vital according to pulp-sensitivity tests. * no active gingival or periodontal conditions. exclusion criteria: * • medically compromised patients, as they will not be able to attend multiple appointments or may require special management. * pregnant women; as radiographs are prohibited. * allergic patients to any of the restorative materials, including anesthetics. * uncooperative patients will not follow the instructions or attend the appointments. tooth related criteria: * retained deciduous teeth; as the research is targeting only permanent teeth. * teeth with previous restorations, which may add another variable to the study (type of old restorative material, extent of recurrent caries). * spontaneous pain or prolonged pain after sensitivity tests (cold and electrical tests) indicating irreversible pulpitis. * negative sensitivity tests, periapical radiolucencies, and sensitivity to axial or lateral percussion indicating pulp necrosis. * teeth presenting external or internal resorption, with adverse pulpal reactions which may affect the outcome of the study. * teeth with cervical caries; which can't be evaluated on periapical radiographs.
automated robotic maneuvering system (rms) vs manual reposition maneuver in treatment of benign paroxysmal positional vertigo (bppv)

Conditions: Benign Paroxysmal Positional Vertigo

Summary: comparison of treatment efficacy of an automated robotic maneuvering system (rms) repositioning chair versus manual positioning maneuvers in benign paroxysmal positional vertigo.

the standard treatments for benign paroxysmal positional vertigo (bppv) are manual positioning maneuvers. this method, beyond being costly and requiring extensive training, is a significant burden on healthcare resources. we developed an automated robotic maneuvering system, hereby known as rms, to tackle this problem. our clinical investigation is two-fold; (1) test the safety of rms and, (2) understand the viability of rms for treating bppv when compared to manual positioning maneuvers.

Eligibility criteria:
inclusion criteria: * characteristic positional nystagmus (for bppv) * positive dix-hallpike * positive supine roll test * positive deep head hanging * vertigo-dizziness imbalance symptom scores compatible with bppv exclusion criteria: * pregnant patients * patients who have taken vertigo suppressing agents (dimenhydrinate) in the last 48 hours * patients taller than 200 cm (2.0 m) * patients who have had a cardiovascular or neurosurgical operation in the last month * patients with retinal detachment and/or glaucoma * lack of treatment cooperation

Keywords: automated robotic vertigo epley maneuver rms chair reposition chair dizziness vestibular diseases multi canal bppv
double-blind placebo surgery trial for treatment of parkinson's disease

Conditions: Parkinson Disease; Surgery

Summary: a double-blind sham surgery-controlled trial was developed to determine the effectiveness of implantation of human embryonic dopamine neurons into the putamen of patients with advanced parkinson's disease (pd), with half the patients receiving the implant (n = 20) and half receiving sham surgery (n = 20). the blind was maintained for 12 months before participants were told which surgery they received, at which time those receiving sham surgery could request the implant surgery.

a double-blind sham surgery-controlled trial was conducted to determine the effectiveness of implantation of human embryonic dopamine neurons into the putamen of patients with advanced parkinson's disease (pd), with half the patients receiving the implant (n = 20) and half receiving sham surgery (n = 20). the goals were to determine whether the cells survived and led to improvement of symptoms, and to examine the effect of age on results of the implantation. quality of life of participants and care partners was also examined at each of the assessment periods (baseline, 4, 8 and 12 months). the blind was maintained for 12 months.

Eligibility criteria:
inclusion criteria: * diagnosed with parkinson's disease (pd) for more than 7 years, improvement in response to levodopa, positive emission tomography scan compatible with presence of pd, improvement of at least 33% on updrs after first morning dose of levodopa exclusion criteria: * mini-mental status exam score of less than 24, hallucinations during levodopa therapy, epilepsy, previous brain surgery, severe depression, another neurologic disorder, cardiovascular disease, and medical contraindication of surgery

Keywords: placebo effect
ultrasound guided - incisionless threaded carpal tunnel release

Conditions: Carpal Tunnel Syndrome

Summary: the overarching long-term goal is to develop a cts treatment center within the hand clinic that offers a variety of established and emerging treatment options in a multidisciplinary program. the ultra-minimally invasive carpal tunnel release would be one component of the program. furthering the knowledge with regard to ultra-minimally invasive carpal tunnel release outcomes would facilitate the hand clinics ability to offer this procedure as a component of individualized care in the cts treatment center to facilitate delivery of the appropriate level of care to the right patient.


Eligibility criteria:
inclusion criteria: * a diagnosis of cts with symptoms including pain, paresthesia's, and weakness of the hand in the median nerve distribution for minimum of 3 months * age 18-65 years old * persistence of symptoms after 6 weeks of conservative treatment such as splinting, activity modification, and/or injection therapy. * electromyographic evidence of mild, moderate, moderately severe, or severe median nerve neuropathy at the wrist * ability to complete all follow up appointments exclusion criteria: * previous cts surgical release on affected side * diabetes mellitus * hypothyroidism * hand arthritis (rheumatologic or osteoarthritis) * pregnancy * electromyographic evidence of any condition other than cts affecting the hand * workman's compensation * participants not willing to make follow-up visits
immediate vs. conditional use of antibiotics in uncomplicated urinary tract infection (uti) - icuti

Conditions: Urinary Tract Infection

Summary: in this study, patients with uncomplicated urinary infection are investigated. it is investigated if treatment of only symptoms of the uncomplicated urinary infection is as effective as treatment with antibiotics with respect to the outcome of the urinary infection. if this is the case, the use of antibiotics in the treatment of uncomplicated urinary infections might be reduced. secondary aim of the study is the safety evaluation of both treatment strategies with respect to saes during treatment. additionally, relapse frequency after 28 days is evaluated.


Eligibility criteria:
inclusion criteria: * women (18 - 65 years) * symptoms of uncomplicated urinary tract infection: dysuria, frequency/urgency of micturition, and/or low abdominal pain * written informed consent exclusion criteria: * fever (\> 38,0) * pain on renal bed percussion * signs of complicated urinary tract infection * urinary tract infection within the last two weeks * antibiotic intake within the last 7 days * repeated intake of pain medication (i.e. ibuprofen, diclofenac) within the last 24 hours, or continuous pain medication * known pregnancy/lactation period * current immunosuppressive therapy * known renal insufficiency * known renal abnormalities * current urine catheterization * serious neurological diseases * limited condition due to other disorders * contraindications towards trial medication * current/anamnestic gastrointestinal haemorrhagia * known allergy towards trial medication * current intake of drugs potentially interacting with trial medication (i.e. oral corticosteroids, anticoagulates) * poor communication/cooperation skills * disability to understand trial information, poor german language skills * current participation in another clinical trial or clinical trial participation within the last 4 weeks

Keywords: bacterial infection
right ventricular pressure waveform monitoring in cardiac surgery

Conditions: Right Ventricular Dysfunction; Right Heart Failure; Congestive Heart Failure

Summary: rv dysfunction has been associated with increased mortality in the icu and cardiac surgical patients. thus, early identification of rv dysfunction at less severe stages will allow for earlier intervention and potentially better patient outcomes. however, so far, no studies have reported prospectively the prevalence of abnormal rv pressure waveform during cardiac surgery and in the icu. the investigator's primary hypothesis is that the prevalence of abnormal rv pressure waveform occurs in more than 50% of cardiac surgical patients throughout their hospitalization. those patients with abnormal rv pressure waveform will be more prone to post-operative complications related to rv dysfunction and failure in the or and icu.

right ventricular (rv) dysfunction is mostly associated to a decrease in contractility, right ventricular pressure overload or right ventricular volume overload. rv dysfunction can occur in a number of clinical scenarios in the intensive care unit (icu) and operating room (or): pulmonary embolism, acute respiratory distress syndrome (ards), septic shock, rv infarction, and in pulmonary hypertensive patients undergoing cardiac surgery. unfortunately, identifying which patients will develop rv dysfunction and then progress towards rv failure have proven difficult. one of the reasons for delaying the diagnosis of rv dysfunction could be the lack of uniform definition, especially in the perioperative period. echocardiographic definitions of rv dysfunction have been described: rv fractional area change (rvfac) \< 35 %, tricuspid annular plane systolic excursion (tapse) \< 16 mm, tissue doppler s wave velocity \<10 cm/s, rv ejection fraction (rvef) \<45% and rv dilation. however, echocardiographic indices alone are insufficient in describing rv function. the diagnosis of fulminant rv failure is more easily recognised as a combination of echocardiographic measures, compromised hemodynamic measures and clinical presentation. rv dysfunction is inevitably associated with absolute or relative pulmonary hypertension because of the anatomic and physiological connection between the rv and pulmonary vascular system. the gold standard for measuring pulmonary pressure is still the pulmonary artery catheter. however, rv output can initially be preserved despite of pulmonary hypertension. it is therefore mandatory that early, objective, continuous, easily obtainable and subclinical indices of rv dysfunction are found and validated to initiate early treatment of this disease.

Eligibility criteria:
inclusion criteria: -male or female patients, age 18 and older, undergoing cardiac surgery and receiving standard of care monitoring utilizing a pulmonary artery catheter. exclusion criteria: * emergency surgery or inability to obtain consent * concomitant diseases such as pericardial constriction, congenital heart disease, severe valvular regurgitation, right ventricular systolic dysfunction, or right ventricular infarction.

Keywords: right ventricular pressure waveform
investigation of the effect of upper gastrointestinal disease on the pharmacokinetics of oral semaglutide in subjects with type 2 diabetes.

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe. the aim of this trial is, to investigate the effect of upper gastrointestinal disease on the pharmacokinetics (the exposure of the trial drug in the body) of oral semaglutide in subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * male or female, aged 18-80 years (both inclusive) at the time of signing informed consent * body mass index (bmi) between 18.5-39.9 kg/m\^2 (both inclusive) * subjects diagnosed clinically with type 2 diabetes mellitus for at least 180 days prior to the first screening visit * for subjects with upper gastrointestinal (gi) disease: diagnosed with chronic gastritis and/or gastroesophageal reflux disease (gerd) at screening exclusion criteria: * female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method (adequate contraceptive measures as required by local regulation or practice). (highly effective contraceptive methods are considered those with a failure rate less than 1% undesired pregnancies per year including surgical sterilisation, hormonal intrauterine devices (coil), oral hormonal contraceptives, sexual abstinence or a surgically sterilised partner) * history of pancreatitis (acute or chronic) * history of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) * unable or unwilling to refrain from smoking during the in-patient periods * any blood draw in excess of 50 ml in the past 30 days, or donation of blood or plasma in excess of 400 ml within 90 days of the first screening visit
us vs fluoroscopic guided renal access

Conditions: Hydronephrosis

Summary: this present study is to compare the result of fluoroscopy, ultrasonography (us) in the guidance of percutaneous nephrostomy pcn .

investigators will enroll 100 patients who are candidates for pcn in the study. by simple random sampling technique, patients will be assigned to two patient groups (group 1, us-guided approach , group 2, fluoroscopy-guided approach.the end point of the study is the comparison of outcome of procedure including stone free rate, transfusion rate, operation time, access time, length of stay and complications.

Eligibility criteria:
inclusion criteria: * infected hydronephrotic kidney onen's grade 2-3 * obstructed good cortex with backpressure changes onen's grade 2-3 . * evaluation of function of asymptomatic hydronephrotic kidney thin cortex onen's grade 4 exclusion criteria: * congenital anomalies of kidney * patient underwent transplant or urinary diversion * solitary kidney
pharmacokinetics of telavancin in normal and obese subjects

Conditions: Healthy

Summary: the purpose of this study is to characterize plasma and urinary concentrations of telavancin following intravenous administration of a single dose of telavancin in healthy subjects who are normal weight, overweight, and obese.

this study is a phase i, open-label, single-dose pharmacokinetic study in healthy adult male and female subjects. eligible subjects will be assigned to one of four groups based on their body mass index and total body weight. subjects will receive a single dose of telavancin depending on subject's group as a 1-hour intravenous infusion. serial blood and urine samples will be collected over 12 hours to determine serum and urinary pharmacokinetics of telavancin. subjects will return for blood and urine sample collection at 24 and 48 hours. safety evaluations will be assessed throughout the study and will include physical examination, vital sign monitoring, clinical laboratory tests, monitoring of adverse events, and markers of kidney injury.

Eligibility criteria:
inclusion criteria: * healthy adult subjects, 18 to 50 years * nonsmokers within the last 1 year * weight \> 110 lbs exclusion criteria: * history of significant hypersensitivity reaction or intolerance to telavancin * aspartate or alanine aminotransferase \> 1.5 times the upper limit of normal * estimated creatinine clearance \ 1.5 mg/dl * female subjects who are pregnant or breast feeding * history of alcohol or substance abuse or dependence within the last 1 year * use of prescription or nonprescription drugs (unless hormonal contraceptives) within 7 to 14 days prior to telavancin administration * participation in a clinical trials within last 30 days * donated blood (\>500 ml) within the last 56 days