Kornimate/medical-research-clean huggingface dataset:
randomized study of midodrine, an alpha adrenergic agonist, in patients with neurally mediated syncope

Conditions: Syncope

Summary: objectives: determine the efficacy of midodrine, a selective alpha 1 adrenergic agonist, in preventing neurally mediated syncope.

protocol outline: this is a randomized, double-blind, crossover, placebo-controlled study. on day one, patients receive either midodrine or placebo. on day three, patients receive the opposite drug.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- diagnosis of neurally mediated syncope (vasovagal fainting) sudden fall in blood pressure and slowing of the heart and temporary loss of consciousness and hemodynamic response to head up tilt --prior/concurrent therapy-- no other concurrent adrenergic agonist or antiagonist --patient characteristics-- fertile patients must use effective birth control

Keywords: neurologic and psychiatric disorders rare disease syncope
developing and testing a comprehensive ms spasticity management program

Conditions: Multiple Sclerosis; Spasticity

Summary: this is a study to determine the impact of education and specific lower extremity stretches for ms-related spasticity. the study will evaluate the acceptance and efficacy of education and stretching using a randomized controlled pilot trial.

participants have 2-4 visits depending on program assignment. all participants will have screening/baseline and follow-up visits. participants in the intervention program will have 2 additional visits with a group of other people with ms to view and discuss the dvds on spasticity education and stretching for lower extremity ms spasticity and then practice the stretching exercises learned. they will be asked to track exercise electronically and on paper for 4 weeks. participants will be compensated for participation.

Eligibility criteria:
inclusion criteria: diagnosis of definite ms * at least 18 years old * able to walk 25 feet independently with common assistive devices if needed * presence of spasticity by self-report interfering with usual daily activities * have an email account and be familiar with using it * willing to track daily exercise for 4 weeks * fluent in english exclusion criteria: other medical or behavioral conditions that would limit participation or completion of the study.

Keywords: multiple sclerosis spasticity stretching exercise rehabilitation
effect of pulpotomy using theracal versus mta on survival rate of cariously-exposed vital permanent molars

Conditions: Caries, Dental

Summary: objective: to assess which is the most efficient pulpotomy medicament on tooth survival in patients with a cariously-exposed vital young permanent molar regarding: absence of postoperative pain, sinus or swelling, internal/ external root resorption, periapical radiolucency), root maturation and decrease chair side time of treated patient. trial design randomized clinical trial (rct), double-blinded with parallel group and allocation ratio (1:1), equivalence framework.

preoperative records will be taken (photos, conventional periapical radiographs, and impression to construct acrylic stent to help standardization on follow up apical radiographs). administration of inferior alveolar nerve block then using rubber dam isolation one of the investigators will remove the caries using large round but under copious amount of coolant and if carious exposure occur, part of the pulp chamber will be removed using sharp spoon excavator. then the pulp status will be assessed if bleeding is controlled with direct irrigation with distilled water for 2 minutes then next step will be taken but if not continue excavation of the pulp till bleeding is controlled. if bleeding is not controlled after performing complete pulpotomy, tooth will be excluded from the study then direct application of capping materials (theracal or mta) according to manufacturer instructions, then riva self-cure glass-ionomer base and composite resin final restoration. one of the investigators will take immediate standardized postoperative periapical radiographs. follow-up will be for 12 months. pre-calibrated blinded dentists will assess out comes separately.

Eligibility criteria:
inclusion criteria: * restorable permanent molars with deep caries and pain could be relieved with analgesics exclusion criteria: * criteria of exclusion of teeth were: * pathological mobility, swelling or tenderness to percussion/palpation; * pathology is shown in the pre-operative radiographic as resorption periradicular or furcation radiolucency, or a widened periodontal ligament space; * at the operative procedure, hemorrhage control is unachievable

Keywords: pulpotomy deep caries permanent molars mta
pd-1 inhibitor concurrent with chemotherapy as neoadjuvant therapy for tnbc

Conditions: Triple Negative Breast Cancer

Summary: the purpose of the study is to address the following hypotheses: the pd-1 inhibitor sintilimab 200mg for intravenous (iv) administration will be given together with three-week epirubincin, cyclophosphamide (ec) × 4 treatments from the second cycle followed by weekly nab-paclitaxel x12 treatments or three-week nab-paclitaxel x4 treatments. this regimen will induce higher pathologic complete response (pcr) rate in triple negative breast cancer than historical pcr rates (30-40%) observed with chemotherapy alone.


Eligibility criteria:
inclusion criteria: * newly diagnosed histologically confirmed stage i-iii, er, pr and her2 negative invasive breast cancer as defined by the asco cap guidelines for whom systemic chemotherapy would be indicated based on physician judgment following standard nccn practice guidelines. exclusion criteria: * patients for whom anthracycline, nab-paclitaxel or antibody therapies are contraindicated.
affinity beyond: anti-aav8 antibody assessment study of boys with dmd

Conditions: Duchenne Muscular Dystrophy

Summary: this is an observational screening study to evaluate the prevalence of anti-adeno-associated serotype 8 (aav8) antibodies in participants with duchenne muscular dystrophy (dmd).

this is an observational screening study to evaluate the prevalence of anti-adeno-associated serotype 8 (aav8) antibodies in participants with duchenne muscular dystrophy (dmd). information collected in this study may be used to identify potential participants for dmd investigational gene therapy clinical trials. this study consists of: * a phone/video interview to provide e-consent and medical history * a single home health visit to collect blood sample for antibody testing * a phone/video call for communication of aav8 antibody test results

Eligibility criteria:
inclusion criteria: * males at least 0 to \<12 years of age * diagnosis of dmd * provision of signed and dated informed consent form (icf) and assent as required per local regulations or requirements exclusion criteria: * prior participation in a gene therapy trial or recipient of a gene therapy drug * other inclusion/exclusion criteria apply

Keywords: dmd duchenne muscular dystrophy duchenne
a clinical trial to investigate the pharmacokinetics and safety/tolerability of ckd-386 in healthy male volunteers

Conditions: Hypertension; Dyslipidemias

Summary: a study to investigate the pharmacokinetic characteristics and safety/tolerability according to formulations of ckd-386 in healthy male volunteers

a sequence-randomized, open-label, 3-way crossover, single oral dose clinical trial to investigate the pharmacokinetic characteristics and safety/tolerability according to formulations of ckd-386 in healthy male volunteers

Eligibility criteria:
inclusion criteria: 1. healthy volunteers aged between ≥20 and ≤45 years old 2. weight ≥ 50 kg, with calculated body mass index(bmi) of ≥ 18.5 and ≤ 27.0 kg/m2 3. those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings 4. those who are judged to be eligible for clinical trials based on laboratory and ecg results during screening tests 5. those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial exclusion criteria: 1. history of presence of hepatobiliary, renal, cardiovascular, endocrine, respiratory, gastrointestinal, hematological, neurologic, psychiatric or musculoskeletal disorders affecting absorption, distribution, metabolism and excretion of the drug 2. genetic problems such as galactose intolerance, lapp lactose deficiency or glucose-galactose malabsorption 3. those who are deemed unfit by the investigators to participate in the clinical trial for other reasons including the results of laboratory tests

Keywords: ckd-386 pharmacokinetics d326 d337 d013
effects of antibiotic prophylaxis on the healing parameters following surgical crown lengthening

Conditions: Tooth Diseases; Tooth Wear

Summary: the goal of this clinical trial is to test the effects of prophylactic antibiotics in healthy individuals who are in need of surgical crown lengthening. the main question it aims to answer is if single dose antibiotics prior to surgical crown lengthening has any effects on the healing outcomes. participants will be asked to take either * 2 g of amoxicillin + clavulanate, or * placebo, one hour prior to surgery and without knowing what medicine they took. researchers will compare the wound healing and self-reported outcomes of the antibiotics group and placebo group.


Eligibility criteria:
inclusion criteria: * in need of surgical crown lengthening operation in one/two teeth exclusion criteria: * systemic diseases which may affect periodontal tissues and/or healing process such as diabetes mellitus * antibiotic or anti-inflammatory drug use in the last 3 months * pregnancy/lactation * chronic steroid, immunosuppressant or nsad use * age \<18 years * positive bleeding on probing at the surgical site and/or active periodontal disease * \<2 mm keratinized mucosa at the surgical site following surgery (estimated surgical outcome before the operation) * miller 2 or 3 tooth mobility * penicillin allergy * unwilling to participate
comparative analysis of the visual performance and patient satisfaction after cataract surgery with implantation of a medicontur monofocal (877pay) or a medicontur extended depth of focus (877pey) iol

Conditions: Cataract; Presbyopia; Ametropia

Summary: the purpose of this multi-center, prospective, randomized, comparative clinical investigation was to evaluate and compare the visual performance at far, intermediate and near distances, the presence of photopic phenomena and patient satisfaction after cataract surgery in patients implanted binocularly with a medicontur monofocal (877pay) or a medicontur extended depth of focus (877pey) iol models. the visit schedule included a total of 6 visits, in addition to the iol implantation surgery, with the listed follow-up timeline: * screening and baseline assessments * day 0 (iol implantation surgery) * day 1 * month 1 * month 3 * month 6 * month 12


Eligibility criteria:
inclusion criteria: * cataractous patients who wish to be partly spectacle independent * cataractous lens changes as demonstrated by best corrected visual acuity of 20/40 or worse either with or without a glare source present (e.g., brightness acuity tester) or with significant cataract-related visual symptoms\* * best corrected visual acuity to be better than 20/25 (0.1 logmar) after cataract removal and iol implantation\* * ≤ 1.0 d of preoperative keratometric astigmatism; * clear intraocular media other than cataract; * given written informed consent by subject; * subjects are willing and able to comply with schedule for follow-up visits; * adult patient exclusion criteria: * corneal astigmatism \> 1.00 d * irregular astigmatism * diabetic retinopathy * iris neovascularisation * serious intraoperative complications * congenital eye abnormality * uncontrolled glaucoma or glaucoma with changes in optical nerve and visual field * pseudoexfoliation syndrome * amblyopia * uveitis * long-term anti-inflammatory treatment * amd * retinal detachment * prior ocular surgery in personal medical history * corneal diseases * severe retinal diseases (dystrophy, degeneration) * severe myopia (if required iol power is lower than 10 d) * inadequate visualization of the fundus on preoperative examination * patients deemed by the clinical investigator because of any systemic disease. * eye trauma in medical history intraoperative exclusion criteria: * tear in capsulorhexis\* * zonular dehiscence\* * posterior capsular rupture vitreous loss and other unexpected surgical complication\* * according to coordinator investigator's decision, the marked inclusion and exclusion criteria were not applied.

Keywords: intraocular lens monofocal iol edof
whole-slide image and ct radiomics based deep learning system for prognostication prediction in upper tract urothelial carcinoma

Conditions: UTUC

Summary: upper tract urothelial carcinoma (utuc), characterized by its anatomical complexity and often aggressive clinical behavior, presents substantial difficulties in accurate diagnosis and reliable prognostication. the stratification of postoperative survival utilizing radiomics features derived from imaging and characteristics from whole slide images could prove instrumental in guiding therapeutic decisions to enhance patient outcomes. in this research, our objective is to construct a deep learning-based prognostic-stratification system designed for the automated prediction of overall and cancer-specific survival in individuals diagnosed with utuc.

upper tract urothelial carcinoma (utuc) can be challenging to accurately diagnose and its course difficult to predict, as the disease manifestations and aggressiveness can differ significantly among individuals. this research seeks to create an innovative system employing artificial intelligence to process patient data, encompassing images from diagnostic scans and surgical pathology slides. this system would then be capable of automatically forecasting a patient's overall survival and their specific likelihood of surviving utuc. such insights could empower clinicians to tailor more effective treatment strategies for each individual patient.

Eligibility criteria:
inclusion criteria: * patients with upper tract urothelial carcinoma (utuc) who had radical nephroureterectomy (rnu). * contrast-enhanced ct scan (e.g., ct urography) less than two weeks before surgery. * complete ct image data and clinical data. * complete whole slide image data. exclusion criteria: * patients with a postoperative diagnosis of non-urothelial carcinoma. * poor quality of ct images and/or whole slide image data. * incomplete clinical and follow-up data.
a study to quantify tumour perfusion for spine metastasis treated with stereotactic body radiotherapy (sbrt)

Conditions: Spine Metastasis

Summary: pre-clinical evidence suggests that radiotherapy reduces tumour-associated vasculature. the investigators will conduct a single-arm prospective study to quantify the reduction in tumour vasculature post-radiotherapy


Eligibility criteria:
inclusion criteria: * age ≥21 years of age * proven metastatic disease, excluding haematological and germ cell neoplasms * life expectancy \>3 months, eastern cooperative oncology group (ecog) 0-2 exclusion criteria: * the patient must not have an allergy to gadolinium contrast that will limit the ability to image the tumour by mri safely even with the use of premedication * egfr \< 30 ml/min or if patient is suffering from acute renal insufficiency * prior radiotherapy to the specified region * recent surgery to affected spinal levels, or patients requiring immediate surgical intervention * spinal instability score (sins) \>12 * symptomatic cord compression (bilksy grade 2 or 3), or worsening neurological deficits * body weight of more than 120kg * pregnancy
the spinal stenosis pedometer and nutrition e-health lifestyle intervention (sspanli) trial

Conditions: Lumbar Spinal Stenosis; Obesity

Summary: obesity is one of the most important determinants of quality of life and function. people with lumbar spinal stenosis may be at increased risk of obesity given walking limitations. spinal stenosis is a very common degenerative condition in people over 45. people with this condition have pain and numbness in the legs during walking, and therefore avoid physical activity. lack of physical activity is related to weight gain and increased risk of chronic disease. objective: the objective of this project is test a new e-health (online) pedometer and nutrition intervention aimed at promoting weight loss and increasing physical activity in overweight and obese individuals with spinal stenosis. methods: the investigators will recruit 88 people with lumbar spinal stenosis who are overweight or obese. half of these people will receive the 12-week intervention, and the other half will receive usual care (no intervention). in weeks 1 and 6, people in the intervention group will meet with a registered dietitian and an exercise physiologist for personalized sessions. they will receive a pedometer and instructions on how to log in to the e-health site (https://sspanli.mtroyal.ca). they will wear the pedometer daily and log in to the website each week for a nutrition education session, a weekly step goal, and tips. the investigators will look to see whether people in the intervention group show greater change in physical activity, body composition and quality of life compared to the individuals who received usual care. relevance: the increasing number of people with spinal stenosis represents a huge health care burden in canada. this intervention could provide a new treatment option that would increase mobility, quality of life, and potentially alleviate the need for expensive treatments like surgery. e-health interventions provide an opportunity for patients to take an active role in their own health, and promote behaviour changes that will result in healthier canadians less likely to access care in the future.


Eligibility criteria:
inclusion criteria: * all subjects will be at least 45 years of age and will have received a diagnosis of lumbar spinal stenosis (lss) by a spine surgeon who has both examined the patient and reviewed imaging results (mri or ct). all subjects will be required to have a bmi of 25 kg/m2 or greater (overweight) and to have maintained a stable body weight for the previous 3 months. exclusion criteria: * any co-morbid conditions that would make participation in a walking program medically inadvisable. * subjects currently participating in a diet or lifestyle intervention for weight loss or who are on medications known to influence bodyweight or glucoregulation (including antidepressants, sibutramine orlistate, insulin and metformin), will be excluded. if participants are scheduled for any type of surgery that could impact mobility during the intervention period, they will be removed from the study.
antibiotics study in preterm premature rupture of the membranes

Conditions: Preterm Premature Rupture of the Membranes

Summary: the purpose of this study is to compare the efficacy on maternal infection, chorioamnionitis and neonatal morbidity and mortality, and to review the evidence and provide recommendations on the use of antibiotics in pprom.

despite major advances in perinatal care, preterm delivery is still the predominant cause of perinatal mortality and a major cause of neurological morbidity and mortality. although the determinants of preterm labor and delivery are uncertain, evidence suggests intrauterine infection is a contributing factor. antibiotic therapy for women in preterm premature rupture of membranes has been a routine practice. however the optimal regimen remains unclear and the choice of latency antibiotic regimen is at the discretion of admitting physician. the group 1 is treated only with cefazolin (1.0mg iv every 6 hours for 7 days). the group 2 is given a combination of cefazolin(1.0mg iv every 6 hours for 7 days) and erythromycin(250mg p.o. four times a day for 7 days). in group 3, clarithromycin (500mg p.o. 4 times a day for 7 days) was treated with cefazolin(1.0mg iv every 6 hours for 7 days). this study is designed to compare the efficacy on maternal infection, chorioamnionitis and neonatal morbidity and mortality and to review the evidence and provide recommendations on the use of antibiotics, especially by comparing the combination regimen in pprom.

Eligibility criteria:
inclusion criteria: * pprom, pa 23+0\~33+0wks * rom \<48 hrs before randomization * singleton * cervical dilatation \<3cm * uterine contraction less than 4 times per 1 hr exclusion criteria: * major fetal malformation * multifetal pregnancy * rupture of the membrane \>8hrs before randomization * prior antibiotics use at local clinic before referral * vaginal bleeding * iioc (incompetent internal os of cervix) * placenta previa * gestational diabetes or overt diabetes * hypertensive disorders in pregnancy * liver cirrhosis * acute renal failure * iugr(intrauterine growth restriction)

Keywords: preterm premature rupture of fetal membranes antibiotic therapy
enhancement of macular pigment density by oral lutein supplementation

Conditions: Age-Related Maculopathies

Summary: the primary objective of empols is an increase in macular pigment density (mpd) and contrast sensitivity (cs) after six months supplementation of oral non-compound ester lutein 10 mg daily, contained in vitaluxplus®.

the primary objective of empols is an increase in macular pigment density (mpd) and contrast sensitivity (cs) after six months supplementation of oral non-compound ester lutein 10 mg daily, contained in vitaluxplus®. primary variable for a significant change will be 10% increase compared to baseline mpd. the measurement will be carried out by means of a modified confocal scanning laser ophthalmoscope (hra) recording autofluorescence images at 488 nm and 514 nm 6. mpd is determined on mpd maps within 0.5 degrees around the center of the fovea. all mpd measurements and photographs will by performed by the bern photographic reading center (bprc). complete examination of study patients comprises testing of standardized visual acuity (etdrs-va), visual contrast sensitivity (cs), biomicroscopy, fundus photography, and a blood sample. participating patients also have to fill out a food frequency questionnaire (ffq-bern) allowing for correction of additional lutein intake by regular diet. moreover possible confounding factors e.g. as sunlight exposure or smoking habits will be assessed. secondary objective of empols is the effect of oral non-compound ester lutein supplementation on cs and etdrs-va during one year. the variable for a significant change in etdrs-va is loss or gain of 7 letters on the etdrs chart, for a change in cs: loss or gain of at least four letters on the pelli-robson cs chart. additionally, serum carotenoid levels of lutein will be determined by high performance liquid chromatography (hplc) for each visit 1.

Eligibility criteria:
inclusion criteria: * age related maculopathy exclusion criteria: * exudative age related degeneration

Keywords: age related macular degeneration supplementation macular pigment