Kornimate/medical-research-clean huggingface dataset:
lsi (lesion index) workflow observational study

Conditions: Paroxysmal Atrial Fibrillation

Summary: this clinical study is a prospective, multicenter, post-market, single-arm, observational study designed to characterize the usage of the lesion index (lsi) with the market-released tacticath contact force ablation catheter, sensor enabled (tacticath se) in subjects with paroxysmal atrial fibrillation (paf) in a real-word environment.

the primary objective of this study is to characterize lsi achieved values for durable lesion formation using the tacticath se catheter in the different anatomical regions around the pulmonary veins (pvs) of the heart during rf ablation for the treatment of drug-refractory paroxysmal atrial fibrillation (paf) secondary objectives of this study are as follows: * to characterize the use of ensite automap and automark module software settings, including lsi threshold (ous), contact force, time, power, flow, and automark spacing using the tacticath se catheter for rf ablation for the treatment of drug-refractory paf. * to characterize lsi achieved values for lesions that reconnected versus those that were durable, both in an acute procedural setting as well as in patients who undergo additional ablations during the 12-month follow-up period after an index rf ablation procedure for the treatment of drug-refractory paf.

Eligibility criteria:
inclusion criteria: 1. subject must provide written informed consent prior to any clinical investigation related procedure. 2. subject is at least 18 years of age. 3. subject is willing and able to comply with the protocol-described evaluations and follow-up schedule. 4. subject plans to undergo a pulmonary vein isolation (pvi) procedure due to symptomatic paroxysmal af using rf ablation. 5. subject is refractory or intolerant to at least one class i or class iii anti-arrhythmic drug. * for the purposes of this study, "intolerant" includes either: 1. subject attempted the drug at any dose and either the subject or their physician chose to discontinue for any reason. 2. subject was offered the drug and refused to take for any reason. exclusion criteria: 1. previous ablation or surgery in the left atria. 2. has an implantable cardiac defibrillator (icd) (pacemakers without defibrillation capacity are allowable). 3. participation in another clinical investigation that may confound the results of this study. 4. pregnant or nursing. 5. presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results. 6. life expectancy less than 12 months.
effects of cerebrolysin on motor recovery in patients with subacute stroke

Conditions: Cerebrolysin

Summary: this study, e-compass is a phase iv clinical trial designed as a multicenter, randomized, double-blind, placebo-controlled, parallel-group study. this study will enroll 75 subacute stroke patients with unilateral motor dysfunction. primary objective is to demonstrate the efficacy of porcine brain peptide to improve motor recovery measured by the improvement ratio of fugl-meyer assessment ((score of fma after 3 weeks - score of fma at baseline) / score of fma at baseline) in patients with subacute stroke.


Eligibility criteria:
inclusion criteria: 1. 1st cortical or subcortical unilateral infarction (supratentorial lesion) 2. confirmed by ct or mri 3. subacute stage: less than 1 week 4. moderate to severe motor function involvement-total of fma: 0-84 5. age: between 18 and 80 years 6. inpatients exclusion criteria: 1. progressive or unstable stroke 2. pre-existing and active major neurological disease 3. pre-existing and active (e.g., on chronic medication) major psychiatric disease, such as major depression, schizophrenia, bipolar disease, or dementia 4. a history of significant alcohol or drug abuse in the prior 3 years 5. advanced liver, kidney, cardiac, or pulmonary disease 6. a terminal medical diagnosis consistent with survival \< 1 year 7. substantial decrease in alertness at the time of randomization, defined as score of 2 on nih stroke scale 8. pregnancy or lactating; note that a negative pregnancy test will be required if the patient is a female in reproductive years 9. any condition that would represent a contraindication to cerebrolysin, including allergy to cerebrolysin 10. current enrolment in another therapeutic study of stroke or stroke recovery 11. total serum bilirubin \> 4 mg/dl, alkaline phosphatase \> 250 u/l, sgot/ast \> 150 u/l, sgpt/alt \> 150 u/l, or creatinine \> 3.5 mg/dl; or cardiopulmonary deficits large enough to interfere with reasonable participation in physiotherapy during the trial. 12. previous porcine brain peptide administration history
correlation between postprandial hypotension and post-induction hypotension in the elderly.

Conditions: Postprandial Hypotension; Post-induction Hypotension

Summary: postprandial hypotension (pph) and post-induction hypotension (pih) are very common in the elderly population and are associated with a variety of poor outcomes.the purpose of this study is to investigate the correlation between pph and perioperative adverse events such as pih in the elderly.

with the deepening of the aging population in our country, the number of elderly patients undergoing surgery is also increasing. elderly patients are at higher risk for hemodynamic instability due to organ dysfunction, decreased physiological reserve, and the coexistence of multiple chronic diseases.postprandial hypotension (pph) is common but often unrecognized among the elderly.pph is defined as a fall in systolic blood pressure of \>20 mm hg, or a decrease to ≤90 mm hg when preprandial systolic blood pressure is ≥100 mm hg within 2 hours of a meal.the pathophysiology of pph is not clear, the decreased cardiovascular autonomic function may play an important role. post-induction hypotension (pih) occurs after induction but before surgical incision and autonomic dysfunction is regarded as one of the major mechanisms.this study aims to prospectively explore the correlation between pph and perioperative adverse events such as pih in the elderly.

Eligibility criteria:
inclusion criteria: 1. elderly patients (≥ 65 years old）; 2. patients with american society of anesthesiologists(asa) grade i-iii; 3. patients scheduled to undergo elective non-cardiac surgery under general anesthesia, with an anticipated surgical duration of over 1 hour； 4. patients with intra-tracheal intubation following intravenous general ；anesthesia induction and maintenance； exclusion criteria: 1. patients with vascular diseases such as aortic aneurysm, aortic dissection, symptomatic atherosclerotic obliterans, buerger's disease, and raynaud's syndrome 2. patients with secondary hypertension, including renal hypertension and endocrine hypertension. 3. patients with chronic kidney disease requiring dietary restrictions or dialysis. 4. patients with parkinson's disease or other conditions causing tremors. 5. patients with problems related to oral food ingestion or those requiring enteral nutrition. 6. patients with difficulties in measuring the upper extremities or communication problems that would interfere with study procedures. 7. patients unable to remain in a supine position for at least 2 hours.
the efficacy and safety of sildenafil citrate used in combination with intravenous epoprostenol in pah

Conditions: Pulmonary Hypertension

Summary: determination of the effects of sildenafil citrate and epoprostenol when used in combination in patients with pulmonary arterial hypertension


Eligibility criteria:
inclusion criteria: * patients with pulmonary arterial hypertension caused by primary pah, associated with connective tissue disease or following surgical repair of a congenital heart lesion exclusion criteria: * ph other than pah
induction related bk viremia in renal transplant patients

Conditions: Disease Due to BK Polyomavirus; Transplantation Infection; Disorder Related to Transplantation

Summary: the increase immunosuppression in our transplant population has led to an unacceptable rate of patients at risk for bk virus nephropathy. reducing induction immunosuppression by switching from thymoglobulin to simulect will reduce the incidence of serum positivity for bk by pcr.

our standard of care has been changed from thymoglobulin to simulect and now patients were enrolled in this observational trial to gather data on their outcomes related to bk viremia and rejection rates. two groups of patients were compared. retrospective (historical or control) group of subjects: patients who had received a kidney transplant and were inducted with thymoglobulin prior to study initiation. prospective group of subjects: patients who is scheduled to receive kidney transplant and will be inducted with simulect (basiliximab). inductions in both groups was/is standard of care at a time of treatment.

Eligibility criteria:
inclusion criteria: * de novo transplant * aged 18-75 exclusion criteria: * serious medical condition which, in the opinion of the principal investigator, might interfere with the subject's ability to successfully complete the protocol. * any medical condition which, in the opinion of the principal investigator, might compromise the safety of the subject in participating in the protocol

Keywords: bk polyomavirus transplantation, kidney transplantation, pancreas
a phase ii study of lonsurf (tas-102) in metastatic platinum and checkpoint inhibitor-resistant bladder cancer

Conditions: Bladder Cancer

Summary: this study evaluates the clinical benefit of tas-102 in participants with metastatic urothelial carcinoma who are resistant to cisplatin or carboplatin front-line and checkpoint inhibitors as second line therapy. all participants will receive tas-102 in oral form twice per day on days 1-5 and days 8-12 of each 28 day cycle.


Eligibility criteria:
inclusion criteria: * ability of participant to understand this study, and participant willingness to sign a written informed consent. * participants must have histologically or cytologically confirmed locally advanced unresectable or metastatic urinary bladder (urothelial) cancer. participants with mixed histologies are permitted as long as transitional cell carcinoma is present in the pathological specimen. * participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension * documented progression on or within 12 months of treatment with one previous platinum-containing regimen or ineligible to receive platinum-containing regimen. neo-adjuvant or adjuvant platinum-based chemotherapy will be deemed to be first-line when participants progressed within 12 months of the last dose * documented progression on prior checkpoint inhibitor or ineligible to receive check-point inhibitor * adequate performance status, organ, and marrow function. * women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence, or to use two forms of adequate contraception. * men of child-bearing potential must not father a child or donate sperm while on this study and for 6 months after their last study treatment exclusion criteria: * patients who have had chemotherapy or radiotherapy within 4 weeks of enrollment/registration. * current or anticipated use of other investigational agents while participating in this study. * psychiatric illness/social situations that would limit compliance with study requirements. * pregnant or breast feeding (if applicable). * patients with known brain metastases * history of allergic reactions attributed to compounds of similar chemical or biologic composition to tas 102. * patients with hiv on anti-retro-viral therapy with thymidine kinase substrates, for example, stavudine, zidovudine, telbivudine. * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. undergoing active treatment for a co-existing malignancy with the exception of adequately treated basal cell carcinoma, squamous cell skin cancer, thyroid cancer or incidental prostate adenocarcinoma detected at radical cystectomy
family assisted severe febrile illness therapy for critically-ill kenyan children

Conditions: Critical Illness; Febrile Illness

Summary: the purpose of this pilot study is to improve inpatient monitoring of severely-ill children admitted to the hospital in low resource settings at kenyatta national hospital in nairobi, kenya. given the high ratio of patients to medical staff in these settings, the lack of reliable patient monitoring tools, and the high rate of early inpatient mortality, we will prospectively train parents as monitoring aids of their hospitalized children. early recognition and intervention in critical illness is important to avoid (further) organ failure. parents will be taught how to assess their child's mental status, work of breathing and capillary refill time which will inform a 3-point severity of illness scale. the severity of illness will be conveyed by the parents to the medical staff via color-coded flag system. the goal is to increase the healthcare provider patient reassessment rate according to patients' level of severity to assist in early recognition and treatment of patients' deterioration.


Eligibility criteria:
inclusion criteria: * admitted to kenyatta national hospital with severe febrile illness which includes presumed malaria, sepsis or septic shock, pneumonia, meningitis or encephalitis * available adult caregiver * enrollment within the first 8 hours of admission to the pediatric ward (modified to 16 hrs later) exclusion criteria: * primary cause of admission is major bleed or hemorrhagic shock, severe trauma or burn, major surgery, known congenital heart disease * previous study enrollment * no available adult caregiver * caregiver unable to give informed consent * caregiver not proficient in english or swahili

Keywords: low and middle income countries limited resource settings early warning signs
motion style acupuncture treatment for low back pain with severe disability

Conditions: Complete Immobility Due to Severe Physical Disability

Summary: motion style acupuncture treatment(msat) is a treatment method in which the patient is exposed to active or passive movement and exercise during acupuncture, as opposed to conventional acupuncture. the purpose of this study is to investigate the effect of msat in the treating pain and severe functional disability in acute lbp patients.

58 patients with acute lbp and severe disability with an oswestry disability index(odi) of 60% or higher were randomly allocated and divided into 2 groups. the experimental group was treated with msat and the control group was treated with intramuscular injections of diclofenac(nsaid). all administrations were limited to 1 session, and comparisons were made of measurements before and after treatment. primary outcomes were measured by the nrs(numerical rating scale) of back pain in active movement. secondary outcomes were measured by the nrs of radiating pain, odi scores, and the patient's global impression of change(pgic) etc. post-treatment follow-up will be performed to measure primary and secondary outcomes with the exception of rom and slr at 2, 4, and 24 weeks after treatment.

Eligibility criteria:
inclusion criteria: * acute lbp(with or without leg pain), with onset within past 4 weeks * severe disability as assessed by an oswestry disability index of 60% or higher * age between 20 and 60 * given consent to lumbar mri * voluntary participation with written consent given to study consent form exclusion criteria: * diagnosis of serious disease(s) which are possible causes of back pain such as malignancy, vertebral fracture, spinal infection, inflammatory spondylitis, cauda equina compression, etc. * prior diagnosis of other chronic disease(s) which could affect effectiveness or interpretation of treatment results such as cardiovascular disease, diabetic neuropathy, fibromyalgia, rheumatoid arthritis, alzheimer's disease, epilepsy, etc. * progressive neurologic deficit(s) or concurrent severe neurological symptoms * unsuitable for or at risk of complications from acupuncture treatment such as patients with clotting disorders, severe diabetes with risk of infection, serious cardiovascular disease, or undergoing anticoagulant treatment, etc. * under prescription of corticosteroids, immuno-suppressant drugs, psychiatric medicine, or other medication considered unsuitable for subjects by the researcher * experience of gastroenteric complications after taking nsaids or currently undergoing treatment for digestive disorders * during pregnancy or suspected pregnancy * subjects considered unsuitable for clinical trial by the researcher

Keywords: acute low back pain motion stlye acupuncture treatment disability msat
safety and efficacy of one dose prophylactic antibiotic in laparoscopic colorectal surgery

Conditions: Colorectal Surgery

Summary: in colorectal surgery, the use of prophylactic antibiotics is recommended. the standard use of antibiotics for colorectal surgery is three doses. it has been reported that the surgical site infection rates of laparoscopic colorectal surgery are lower than open colorectal surgery. however, the evidence of proper application of antibiotic for laparoscopic colorectal surgery is still not enough. the investigators are researching the efficacy and safety of one dose prophylactic antibiotic in laparoscopic colorectal surgery.

in colorectal surgery, the use of prophylactic antibiotics is recommended. the standard use of antibiotics for colorectal surgery is three doses. one randomized controlled study reported that surgical site infection rates of three doses prophylactic antibiotics are lower than those of one dose in colorectal surgery (4.3 versus 14.2%). but, surgical site infection rates between one dose and three doses were not different in laparoscopic subgroup of this study (11 versus 11%) it has been reported that the surgical site infection rates of laparoscopic colorectal surgery are lower than open colorectal surgery. however, the evidence of proper application of antibiotic for laparoscopic colorectal surgery is still not enough. the investigators are researching the efficacy and safety of one dose prophylactic antibiotic in laparoscopic colorectal surgery.

Eligibility criteria:
inclusion criteria: * patients have laparoscopic colorectal surgery for cancer at national cancer center * patients should sign a written informed consent * age between 18-80 years * adequate bone marrow function hb ≥ 10g/dl (after treatment for simple iron deficiency anemia) wbc ≥ 3,000/mm3 plt ≥ 100,000/mm3 * adequate kidney function creatinine ≤ 1.5 mg/dl * no remarkable evidence of heart dysfunction and lung dysfunction exclusion criteria: * patients undergo emergency surgery with multiple symptoms * open colorectal surgery for cancer or conversion to an open procedure * patients who undergo only ostomy surgery * palliative surgery * surgery combined with other organs * patients on treatment with recurred cancer * patients who have active bacterial infection and required parenteral antibiotics * patients have an allergy to cefoxitin * other organ cancer history(except who had radical excision for skin cancer) * presence of other serious disease * mentally ill patients * legally unable to participate in clinical trial * lactating or pregnant women * patients who will obviously fail to regular follow-up visit or will be off study voluntarily * not eligible to participate for other reasons by doctor's decision

Keywords: colorectal surgery surgical wound infection laparoscopy anti-bacterial agents
project:intensive habilitation (pih)

Conditions: Cerebral Palsy

Summary: the purpose of this study is to document that taking part in this program is beneficial for the child, its parents and local professionals. the study hypothesis are: intensive training will speed up the childs motor, cognitive and social development. intensive habilitation will increase the childs family's empowerment children having participated in this intensive habilitation will speed up their process of development further than children in the control group the cooperation between first and second line health service is strengthened by participation in the intensive habilitation program the professionals in the first line(community)in norway that participates in this program increases their empowerment and motivation


Eligibility criteria:
inclusion criteria: about three years of age cerebral palsy multidisciplinary diagnosed - exclusion criteria: not have pervasive developmental disorder (pdd) no specific speech and language disorders no serious sensory defects -

Keywords: cerebral palsy functional training preschool children gross motor functional classification level gross motor functional measure test pediatric evaluation of disability inventory parental stress index
impact of 30 mg/kg amikacin and 8 mg/kg gentamicin on serum concentrations in critically ill patients with severe sepsis

Conditions: Sepsis

Summary: low first-dose peak serum concentrations of amikacin and gentamicin are commonly reported in icu patients. the present study aimed to assess whether 30 mg/kg amikacin or 8 mg/kg gentamicin achieved target concentrations in icu patients with severe sepsis.


Eligibility criteria:
inclusion criteria: * icu patient with severe sepsis * treated with aminoglycosides exclusion criteria: * renal replacement therapy * allergy to aminoglycosides * confirmed and/or suspected to have myasthenia * icu-acquired neuromuscular disorder * under guardianship * prisoners * the patient has already participated in the present protocol
pk study of telmisartan/rosuvastatin fdc compared to combination of telmisartan and rosuvastatin

Conditions: Dyslipidemia & Hypertension

Summary: this is a 2 by 2 cross-over study to evaluate pharmacokinetics of telmisartan and rosuvastatin fdc compared to reference telmisartan and rosuvastatin coadministered in two groups enrolling healthy adult male and female subjects under fasting conditions. subjects will be admitted to the clinic in the evening before day 1. all subjects will receive a single oral dose of telmisartan/rosuvastatin fdc or telmisartan and rosuvastatin co-administered in the morning on day 1. all the subjects will remain in the clinical unit until completion of all assessments on day 2 including collection post-dose pk sample. subjects will return to the clinic for pharmacokinetic samples at scheduled time. the two treatment periods will be separated by a washout period.


Eligibility criteria:
inclusion criteria: 1. healthy male and female aged 20 to 50 with a body mass index(bmi) between 18.5 and 25 kg/m2 2. acceptable medical history, physical examination, laboratory tests and ekg, during screening 3. provision of signed written informed consent 20\~50 yrs old, healthy korean subjects exclusion criteria: 1. history of and clinically significant disease 2. sitting blood pressure meeting the following criteria at screening: 150 ≥ systolic blood pressure ≤100 (mmhg) and 100 ≥ diastolic blood pressure ≤ 65 (mmhg) amd 100 ≥ heart rate ≤ 40 3. a history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs. 4. administration of other investigational products within 90 days prior to the first dosing. 5. administration of herbal medicine within 28 days or administration of ethical drugs within 14 days or administration of over-the-counter (otc) drugs within 7 days prior to the first dosing of the investigational product (if the investigator (study doctor) determines that the person meets other criteria appropriately, the relevant person may participate in the study). 6. have ast(sgot) or/and alt(sgpt) \> 3 times of normal upper limit at the time of screening 7. volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ecgs, or vital signs.