Kornimate/medical-research-clean huggingface dataset:
the study to compare smart nitinol stent and balloon angioplasty

Conditions: Superficial Femoral Artery Occlusions

Summary: this is a multi-center prospective, randomized, two-arm study evaluating performance of the cordis smart™ nitinol stent system compared to balloon angioplasty. patients will be randomized on a 1:1 basis. it is anticipated that a total of 120 patients will be entered into the study. objective of the study is: performance of the cordis s.m.a.r.t.™ (control™) nitinol stent system for the treatment of superficial femoral artery (sfa) long de novo or restenotic lesions (≥ 70% stenosis or occlusions) in comparison with balloon angioplasty as determined by binary restenosis (≥50% restenosis based on a peak systolic velocity ratio ≥ 2.5) at one year as demonstrated by duplex sonography.

the study population will consist of 120 symptomatic peripheral vascular disease patients with sfa occlusions. the disease will consist of symptomatic, de novo or restenotic occlusions (5 - 22 cm) on diagnostic imaging. the occlusions must not extend beyond the proximal popliteal artery. for the purpose of this protocol, no lesion within 3 cm of the upper part of the patella may be treated. at least one calf vessel must be patent. reference vessel diameter must be \>= 4.0 to \<= 6.0 mm. trial participants who meet all entry criteria, will be randomized to the smart™ nitinol stent or balloon angioplasty. patients will be followed for 12 months after the procedure. study examinations will be done at screening, procedure time, discharge, 1, 6 and 12 months after the study procedure. this study will be conducted as an investigator initiated multicenter study with 6 study centers in switzerland. principal investigators will be prof. amann, pd dr. med t. pfammatter (university hospital zürich) and prof. i. baumgartner, prof. j. triller (university hospital bern).

Eligibility criteria:
inclusion criteria: 1. symptomatic leg ischemia by rutherford classification (category 1, 2, 3, 4 or 5); duration of intermittent claudication (category 1-3) should be at least 3 months; 2. one de-novo or restenotic sfa with an occluded length \> 5 to \< 22 cm; 3. patent popliteal artery on the index side (without \> 50% stenotic (re) stenotic lesions) and at least single vessel infrapopliteal runoff (without \> 50% stenotic (re) stenotic lesions). however, balloon angioplasty to further improve the blood flow is allowed at the index procedure. exclusion criteria: 1. revascularization involving the same limb 30 days prior to the index procedure or a planned revascularization within 30 days after the index procedure; 2. patients having severe stenoses or total occlusions of the iliac artery on the same side must be excluded. however, intervention to restore adequate blood flow during the index procedure (prior to the treatment of the target lesion) is allowed; 3. requiring stent placement in the popliteal artery. for the purpose of this protocol all lesions are to be located at least three centimetres proximal to the superior edge of the patella.
ostap versus tap for postoperative pain management in laparoscopic cholecystectomy patients

Conditions: Pain Postoperative

Summary: the aim of the study is to compare the effectiveness and opioid sparing effects of tap and ostap in patients undergoing laparoscopic cholecystectomy.

patients undergoing laparoscopic cholecystectomy were separated into 3 groups. group 1: received tap block group 2: received ostap group 3: no block standard general anesthesia was induced and maintained in all patients. at the end of the operation patient controlled analgesia with morphine was applied to all patients. pain scores were evaluated at 0,2,4,6,12,24 hours postoperatively. total morphine consumption and pain scores were compared.

Eligibility criteria:
inclusion criteria: * scheduled for laparoscopic cholecystectomy * asa status i-ii exclusion criteria: * local anesthetic allergy * coagulopathy * infection at procedure site

Keywords: tap ostap postoperative pain
parasite clearance time and time to recurrent infection following treatment with artemether/lumefantrine

Conditions: Instantaneous Clearance

Summary: plasmodium falciparum resistance against artemisinins has been confirmed in south-east asia and it is expressed phenotypically as a slow rate of parasite clearance. nonetheless, it is not known whether the problem exist in tanzania. this study assessed parasite clearance time and time to recurrent infection following treatment with artemether/lumefantrine (al) among children with uncomplicated malaria.

artemether/lumefantrine (al) has been in wide scale use in tanzania since 2007 as first line treatment for uncomplicated falciparum malaria. nonetheless, reports of confirmed resistance against artemisinin derivatives expressed phenotypically as prolonged parasite clearance have emerged from south-east asia (sea), signifying reduced parasites susceptibility to the otherwise rapidly acting artemisinins. prolonged clearance is associated with an increase in day 28 treatment failure, gametocytes carriage and transmission of resistance. nonetheless, no detailed study has been done in east africa to assess parasite clearance time following treatment with artemisinin based combination therapies (acts). in order to evaluate time to parasite clearance following treatment with al, we conducted a detailed clinical trial with twenty blood sampling time points prior, during and after treatment. detailed sampling allowed us to assess parasite clearance, and selection of plasmodium falciparum multidrug resistance (pfmdr) 1 n86y and plasmodium falciparum chloroquine resistance transporter (pfcrt) k76t genes between different time points and its association with parasite clearance and recurrence. furthermore, as a sensitive tool and an ideal early warning system, nested polymerase chain reaction (pcr) was used to assess parasite clearance and compare it with microscopic findings.

Eligibility criteria:
inclusion criteria: * age 6-120 months * presence of asexual p. falciparum parasitaemia of 2000-200 000/μl * no general danger signs or severe malaria present * hemoglobin ≥5 g/dl * history of fever within 24 hours or axillary temperature ≥ 37.5 degree celsius * no other cause of fever is detectable * no severe malnutrition * guardian/patient has consented exclusion criteria: * general danger signs or signs of severe falciparum malaria * severe malnutrition * febrile condition due to diseases other than malaria * regular medication which might interfere with antimalarial pharmacokinetics * contraindications to any medicine being used

Keywords: clearance time recurrence time artemether/lumefantrine p. falciparum uncomplicated malaria children
ultrasound-guided inguinal field block (genitofemoral, iliohypogastric and ilioinguinal nerve block) for inguinal hernia surgery

Conditions: Inguinal Hernia

Summary: the purpose of this study is to investigate the analgesic efficacy of an ultrasound-guided inguinal field block (block of the genitofemoral, iliohypogastric and ilioinguinal nerve).

inguinal hernia repair accounts for 10-15% of all operations in general surgery. moderate to severe pain can occur at the first day after inguinal hernia repair in 25% of patients at rest and in 60% during activity. on day 6 after the operation the incidence can be as high as 11% at rest and 33% during activity. ultrasound imaging for regional anesthesia techniques have improved the success and safety rate of nerve blocks. we hypothesized that a procedure consisting of an ultrasound-guided inguinal field block (genitofemoral, iliohypogastric and ilioinguinal nerve block and incision line infiltration) could effectively control postoperative pain compared to selective unilateral subarachnoid anesthesia.

Eligibility criteria:
inclusion criteria: * bmi (body mass index) \< 30 * non severe liver, renal or cardiac disease * no allergy or contraindications to any of the study drugs * american hernia society score type i-ii-iv-v hernia * no pain or chronic analgesic administration in the preoperative period * no previous surgery of the inguinal region * normal coagulation parameters and platelet count (\> 100.000). * dicumarol and aspirin suspension for \> 7 days * correctly administrated premedication * no systemic infections * no contraindications to subarachnoid anesthesia exclusion criteria: * bmi (body mass index) \> 30 * severe liver, renal or cardiac disease * allergy or contraindications to any of the study drugs * american hernia society score type iii-vi-vii-0 hernia * pain or chronic analgesic administration in the preoperative period * previous surgery of the inguinal region * anormal coagulation parameters and platelet count (\< 100.000). * no dicumarol and aspirin suspension for \> 7 days * incorrectly administrated premedication * systemic infections * contraindications to subarachnoid anesthesia
prognosis of srd patients in the icu

Conditions: Systemic Rheumatic Diseases; Intensive Care Unit; Corticosteroids

Summary: critically ill systemic rheumatic disease (srd) patients have benefited from better provision of rheumatic and critical care in recent years. recent comprehensive data regarding in-hospital mortality and most importantly long-term outcome are scarce. the aim of this study is to assess short and long-term outcome of patients with srd admitted to the icu in a retrospective cohort study (2006 - 2016).


Eligibility criteria:
inclusion criteria: * all consecutive srd patients admitted to icus during the study period * at least one urine sample exclusion criteria: * age \< 18 years * persons under protection * paritcipation rejections * admition to the icu after scheduled surgery or trauma or suicide attempt unrelated to neurological involvement of srd * cancer treated with chemotherapy within a month before icu admission

Keywords: outcomes prognostic factors
using hydration monitor to detect changes in the hydration status athletes

Conditions: Dehydration

Summary: the study will aim to evaluate the correlation between changes in ultrasound velocity and measures of hydration status including urine specific gravity, plasma and urine osmolality in male and female young adults after undergoing an acute dehydration and rehydration. the study will also test the hypothesis that body dehydration is a generalized physiological process equally affected all body muscles by comparing the data obtained on calf and biceps muscles.


Eligibility criteria:
inclusion criteria: * male or female athletes * ages 18-25 years old exclusion criteria: * open wounds or rashes on calf testing area * active skin infection * pregnant female subjects

Keywords: dehydration
efficacy, safety and tolerability study of rn6g in subjects with geographic atrophy secondary to age-related macular degeneration

Conditions: Age-Related Maculopathy

Summary: the purpose of this study is to determine the efficacy, safety and tolerability of multiple doses of rn6g in subjects with geographic atrophy secondary to age-related macular degeneration.

the trial was terminated early on april 12, 2013 due to an organizational decision, which was not based on safety or efficacy concerns. subjects who were already enrolled into the study were followed.

Eligibility criteria:
inclusion criteria: * men and women between the ages of 60 and 90 years. * diagnosis of a geographic atrophy (ga) secondary to dry age-related macular degeneration. * best corrected visual acuity (bcva) of 20/80 or better in the study eye exclusion criteria: * evidence of ocular disease other than geographic atrophy (ga) secondary to dry age-related macular degeneration in the study eye. * history or diagnosis of exudative (wet) age-related macular degeneration, with subretinal or choroidal neovascular lesions in the study eye. * presence of disease or condition that might compromise the cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, central nervous, immune, or gastrointestinal system

Keywords: phase 2 advanced dry age-related macular degeneration geographic atrophy rn6g
improving adherence in patients with hypertension - a novel use of communication technology

Conditions: Hypertension

Summary: treating hypertension is known to decrease morbidity and mortality. despite this 70% of patients do not have adequately controlled blood pressure. the main reason for this is non-adherence to recommended drug therapy. although strategies have been developed to improve adherence many are time consuming and expensive. we propose to use communications technology to develop a novel means of improving adherence to antihypertensive therapy. we will conduct a randomised, single-blinded, controlled study to assess the impact of a real-time, automated reminder system on adherence rates. this will involve adapting two pieces of currently available technology - the electronic pill bottle and the ambient globe. the globe will change colour in response to information received, via a wireless link, from the patient's electronic pill bottle. we hypothesise that this will provide patients with an up to date, but unobtrusive, reminder of their adherence status and thus effect positive behavioural change. we will measure the impact of this intervention on adherence rates as well as assessing patient views and the impact on provider workload. this trial will elucidate the role of communications technology in improving adherence behaviour and allow us to develop further strategies to tackle this major health issue.


Eligibility criteria:
inclusion criteria: * prescription of a once-a-day dose of atenolol. * morisky score of less than or equal to 2 (explanation in 'equitable selection of subjects'). * fluency in english. * age 45-65 inclusive. * primary care physician consent to the patient taking part. exclusion criteria: * patients prescribed more than two anti-hypertensive agents. * patients prescribed more than four medications in total. * patients on secondary prevention following cardiac event or stroke. * morisky score of more than 2. * patients with visual impairment or color-blindness. * patients with congenital or acquired cognitive impairment. * patients with a cardiac pacemaker

Keywords: adherence hypertension telemedicine
treatment of oral warts in hiv+ patients

Conditions: Papillomatosis; HIV Infections

Summary: this is a study to test lozenges of interferon-alpha that are dissolved in the mouth as a treatment of oral warts in hiv-positive adults. the hypothesis of this study is that interferon-alpha will be safe and that a higher percentage of subjects given interferon-alpha will experience a complete or nearly complete remission of their oral warts compared to subjects given placebo.

human papilloma virus (hpv) can cause warts to form in the mouth of infected patients, particularly those with reduced immunity such as people infected with hiv. this is a randomized, double-blind, placebo-controlled trial to determine whether interferon-alpha, delivered in low doses via orally dissolving lozenges, can reduce or eliminate these warts in hiv+ subjects who are receiving combination anti-retroviral therapy (haart). all potential subjects will have their warts examined and measured at a screening visit. a small amount of one wart (i.e. a biopsy) will be removed for microscopic evaluation to confirm hpv infection and a small amount of blood will be collected for testing. subjects that qualify for entry will return for a baseline visit at which they will be randomized to active or placebo treatment for 24 weeks. three out of four subjects will receive active treatment in this study. subjects must return to the clinic every 6 weeks during treatment to have their warts re-examined. at these follow-up visits, subjects will be asked to complete a brief questionnaire regarding any perceived changes in their warts and their overall mouth condition. a small amount of blood will be taken at the final study visit at week 24 to assess the safety of the interferon lozenges.

Eligibility criteria:
inclusion criteria: * must have tested positive for hiv. * must have two or more warts inside the mouth. * must be receiving a standard course of anti-retroviral therapy (haart). exclusion criteria: * must not be receiving oral or injected steroids. * must not be taking other drugs for treatment of oral warts. * must not have other active hiv-related opportunistic infections.

Keywords: human immunodeficiency virus human papilloma virus warts, oral papillomatosis treatment experienced
coordination of hemiparetic movement after post-stroke rehabilitation

Conditions: Stroke

Summary: this study will determine whether a therapeutic exercise program for improving motor coordination in locomotor tasks in post-stroke, hemiparesis patients will result in cns recovery. the study will develop relationships between the improved motor performance and motor coordination during the locomotor task and the functional effects of the exercise program(e.g., gait variables.)

primary objective of this study is to determine whether a therapeutic exercise program which targets the functional recovery of persons with the post-stroke hemiparesis results in cns recovery (improved motor coordination). they will determine whether motor coordination during a locomotor task is improved after an exercise program. they will then develop relationships between the improved motor performance and motor coordination during the locomotor task and the functional effects of the exercise program(e.g., gait variables) overall goal is to develop a more rational basis for the design of stroke rehabilitation programs which target individuals most likely to recover and which are based on physiological principles. this study will supplement an nih funded randomized clinical trial to evaluate a post-stroke exercise program designed to increase balance, strength, and endurance. study will include 60-70 prospective patients enrolled in the randomized clinical trial at kansas university center on aging. between oct 1999 and oct 2001.

Eligibility criteria:
inclusion criteria: functionally impaired elderly exclusion criteria:

Keywords: stroke, hemiparesis, cns, motor coordination
swallowing and oral sensory complaints in preterm children

Conditions: Prematurity; Dysphagia; Feeding Disorder of Infancy or Early Childhood

Summary: objective preterm children face an elevated risk of neurodevelopmental delays and feeding difficulties, necessitating early assessment to support their long-term health. this study investigates swallowing disorders and oral sensory problems in children aged 3-10 years born preterm. methods parents of preterm children completed two validated tools: the pediatric eating assessment tool (pedi-eat-10) to assess swallowing difficulties and the oral sensory profile (oral-sp) to evaluate oral sensory processing. data collected included age, gender, gestational age, height, weight, neonatal intensive care unit (nicu) stay duration, feeding methods (e.g., tube feeding, pacifier, bottle use), medical history, and prior interventions like speech-language therapy.


Eligibility criteria:
inclusion criteria: inclusion criteria were having a preterm child (born before 37 weeks), aged 3-10 years, being turkish-speaking, and volunteering. exclusion criteria: participants were excluded if they withdrew during data collection.
the effect of chan-chuang qigong on fatigue, exercise capacity and quality of lifpatients with heart failure

Conditions: Heart Failure NYHA Class II

Summary: this study aimed to investigate the impact of chan-chuang qigong on fatigue, exercise capacity, quality of life, and heart function in heart failure patients. the study recruited 72 heart failure patients from a medical center in northern taiwan for an experimental study. the participants were randomly divided into two groups: patients in experimental group was given twice daily, every 15 minutes chan-chuang qigong, control group received the regular care for heart failure patients. data was collected using the piper fatigue scale, a six-minute walking test, and the minnesota living with heart failure questionnaire before the intervention as the baseline, and at the 4th, 8th, and 12th weeks during the intervention. it is hoped that through this study, we can understand the effect of chan-chuang qigong on improving fatigue, exercise capacity and quality of life in patients with heart failure, and provide an additional choice and reference for the treatment and care of patients with heart failure in the future, and recommend future treatment of heart failure.


Eligibility criteria:
inclusion criteria: 1. at least 20 years of age. 2. cardiology specialist diagnoses heart failure based on clinical examination 3. heart failure classified as new york heart association class ii (nyha ii) 4. left ventricular ejection volume \<50% (hfmref and hfref) 5. according to the doctor's assessment, it is not appropriate to exercise 6. clear consciousness and ability to communicate 7. agree to participate in this study after explanation and sign the consent form exclusion criteria: 1. renal failure treated with hemodialysis 2. severe arrhythmias, such as third-degree atrioventricular block, frequent ventricular pulses and heartbeats greater than 130 beats/min at rest 3. about to undergo coronary interventional surgery or cardiac surgery within 3 months 4. coronary interventional surgery or cardiac surgery in the past 3 months
ruxolitinib and chidamide for acute t cell lymphoblast leukemia/ lymphoblastic lymphoma

Conditions: Peripheral Blood Stem Cell Transplantation

Summary: the purpose of this study is to determine the efficacy and safety of ruxolitinib and chidamide intensified conditioning regimen in patients with acute t cell lymphoblast leukemia/ lymphoblastic lymphoma underwenting haploidenticl peripheral blood stem cell transplantation.

haploidenticl peripheral blood stem cell transplantation should be offered to eligible patients with acute t cell lymphoblast leukemia/ lymphoblastic lymphoma whenever feasible. to further improve the outcome of transplantation patients with acute t cell lymphoblast leukemia/ lymphoblastic lymphoma, we developed a modified bu/cy conditioning regimen intensified by ruxolitinib and chidamide. in this study, we tested the efficacy and feasibility of the modified bu/cy conditioning regimen intensified by ruxolitinib and chidamide in patients with acute t cell lymphoblast leukemia/ lymphoblastic lymphoma undergoing allogeneic peripheral blood stem cell transplantation.

Eligibility criteria:
inclusion criteria: 1. high risk acute t cell lymphoblast leukemia/ lymphoblastic lymphoma with the indications for allogeneic transplantation; 2. have haploidentical donors 3. all patients should aged 12 to 65 years; 4. liver function: alt and ast≤2.5 times the upper limit of normal , bilirubin≤2 times the upper limit of normal; 5. renal function: creatinine ≤the upper limit of normal; 6. patients without any uncontrolled infections , without organ dysfunction or without severe mental illness; 7. eastern cooperative oncology group (ecog) performance status ≤2; 8. have signed informed consent. exclusion criteria: 1. pregnant women; 2. patients with mental illness or other states unable to comply with the protocol;