Kornimate/medical-research-clean huggingface dataset:
efficacy of magnetic resonance-guided high intensity focused ultrasound for the ablation of breast cancer

Conditions: Breast Cancer, Invasive Ductal

Summary: the purpose of the study is to evaluate the efficacy of a dedicated magnetic resonance guided high intensity focused ultrasound (mr-hifu) unit in ablating breast cancer by comparing mr imaging and pathologic specimen after resection. single-center, single-arm, non-randomized trial

the dedicated mr-hifu unit has been shown to be safe and feasible to ablate breast tissue. the planned study should address the possibility to completely ablate breast cancer with the dedicated breast mr-hifu unit. the result of the mr-hifu therapy should be monitored by imaging (contrast enhanced mri) as well as with histopathological correlation after surgery. the patient population would consist of female patients with proven breast cancer scheduled for surgical lumpectomy or mastectomy. the idea is to evaluate a minimal invasive method to treat breast cancer as a potential alternative to surgical resection in the future

Eligibility criteria:
inclusion criteria: * informed consent as documented by signature * world health organization (who) performance status≤ 2 * body weight ≤ 80 kg * biopsy proven invasive breast cancer with a size of ≤3.0cm (tnm classification: ct1-2 n0-2 mx ). * histological type of tumor: invasive ductal carcinoma (idc) * patient is scheduled for surgical resection of tumor at study site * tumor location within the reach of the hifu transducers with the patient in prone position; distance from skin and pectoral muscle to the tumor ≥ 1.0 cm. * target breast fits in the cup of the dedicated mr-hifu breast system exclusion criteria: * neoadjuvant systemic therapy * prior radiotherapy in target breast * contraindications for mri * contraindication for application of gadolinium-based contrast agent * contraindication for procedural sedation analgesia * macro-calcifications in or around the targeted tumor * scar tissue or surgical clips in the direct path of the ultrasound beams * women who are pregnant or breast feeding, * intention to become pregnant during the course of the study, * lack of safe contraception, defined as: female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases. * known or suspected non-compliance, drug or alcohol abuse, * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant, * participation in another study with investigational drug/device within the 30 days preceding and during the present study, * previous enrolment into the current study
cognitive-motor rehabilitation, stimulant drugs, and active control in the treatment of adhd

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the investigators administered a randomized controlled trial (rct) through random assignment of children with adhd into three different groups to compare the effects of cognitive-motor rehabilitation, immediate release methylphenidate, and an active control on the executive functioning, learning, and behavioral symptoms of children with adhd.


Eligibility criteria:
inclusion criteria: * receiving adhd diagnosis * aged between 9 and 12 years * intelligence quotient (iq)\>90 exclusion criteria: * severe co-morbid disorders, such as depression, op-positional defiant disorder and conduct disorder * a history of seizures during past 2 years * disability or handicap preventing the child from participating cognitive-motor exercises * sever medical conditions requiring immediate medical treatment

Keywords: adhd cognitive-motor rehabilitation active control group stimulant medication
acetaminophen versus iv hydromorphone for pain in the elderly in the ed

Conditions: Acute Pain

Summary: intravenous opioids are the mainstay of acute, severe pain treatment in emergency departments (ed) across the country. acetaminophen, given orally, has also been used for treatment of mild to moderate pain. the more potent intravenous (iv) form of acetaminophen has been widely used in europe for more than 20 years as post-surgical analgesia and received full fda approval in the usa in 2010. as part of a continuing set of studies whose goal is to optimize treatment of pain among elderly ed patients, this randomized study will compare efficacy and safety of iv acetaminophen to iv hydromorphone.


Eligibility criteria:
inclusion criteria: 1. age equal to 65 or greater 2. pain onset within 7 days with severe pain 3. has capacity to provide informed consent 4. understanding english or spanish exclusion criteria: 1. use of tramadol or opioids within 7 days 2. use of acetaminophen or non-steroidal anti-inflammatory medications within 8 hours 3. chronic pain syndrome: daily pain for \> 3 months. sickle cell anemia, osteoarthritis, fibromyalgia, and peripheral neuropathies 4. conditions which may affect acetaminophen or opioid metabolism such as cirrhosis (child pugh a or worse), kidney impairment (ckd 3 or worse), active hepatic disease or severe dehydration 5. alcohol intoxication 6. systolic blood pressure: \< 100 mmhg 7. heart rate: \< 60 beats per minute 8. oxygen saturation: \< 95% on room air 9. use of monoamine oxidase (mao) inhibitors in the past 30 days 10. use of transdermal pain patch or oral opioid \> 10 days in the prior month 11. prior enrollment in the same study
a pilot weight control intervention at hphc

Conditions: Obesity

Summary: the purpose of this study is to examine how adults can improve their physical activity levels and eating habits using an interactive web-based weight control program and regular contact with a dietician.

* all study participants must have regular access to the internet, however, the study will not provide this access. participants will be randomly placed in one of two study groups (group 1 or group 2). * group 1 participants will be asked to make 3 in-person visits, each lasting 75-90 minutes. the following information will be collected: name, mailing address, telephone number, and email address. during the study visit, the following measurements will be taken: height, weight, waist circumference, blood pressure and dietary patterns. * group 1 participants will also receive counseling around diet and physical activity from a registered dietician and be asked to use a specialized website that will allow them to track eating and physical activity patterns, learn new weight management skills, interact with the dietician, and receive support from other participants. * group 1 will also receive 5 telephone counseling calls with a health counselor. during the telephone calls, we will teach the participant new skills such as tracking diet and physical activity, goal-setting and staying motivated. * group 2 participants will be asked to make 2 in-person visits, each lasting 75-90 minutes in length. the following information will be collected: your name, mailing address, and telephone number. during the study visit, the following measurements will be taken: height, weight, waist circumference, blood pressure and dietary patterns.

Eligibility criteria:
inclusion criteria: * 25 to 65 years of age * body mass index between 30-40 kg/m2 * non-smoker (quit within previous 6 months) * comfort reading and speaking english * stage 1 hypertension * not currently pregnant * regular web access from home

Keywords: weight control
first in human study to investigate the safety, tolerability, pharmacokinetics and to explore pharmacodynamics of bay1834845

Conditions: Pelvic Inflammatory Disease

Summary: this study is a first in human study that will investigate the safety, tolerability and pharmacokinetics and explore the pharmacodynamics of ascending single doses of bay1834845 using a placebo controlled, randomized, single center design.


Eligibility criteria:
inclusion criteria: * healthy male subject * age: 18 to 50 years (inclusive) at the first screening visit * body mass index (bmi) : 18.5 ≤ bmi ≤ 30 kg/m² exclusion criteria: * clinically relevant findings in the physical examination * relevant diseases within the last 4 weeks prior to the first study drug administration * incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal * use of systemic or topical medicines or substances which oppose the study objectives or which might influence them within 4 weeks before first study drug administration
a predictive algorithm in aortic surgery

Conditions: Hemodynamic

Summary: we will enroll patients scheduled for abdominal aortic aneurysm repair and divide in two groups; in the control group the hemodynamic optimization will be made based on standard cardiovascular parameters showed in the hemosphere platform. in the interventional group the hemodynamic optimization will be made based on the hypotension prediction index.


Eligibility criteria:
inclusion criteria: * planned aortic surgery acceptance of written informed consent exclusion criteria: * body mass index \> 35 kg/m2 * atrial fibrillation * urgent surgery * end-stage renal disease * pregnancy * refusal of the consent
accent cardiac mri study

Conditions: Bradycardia

Summary: the aim of this study was to assess safety and efficacy of sjm mri conditional pacing system. the study hypothesized that cardiac mri scan would not affect performance of sjm mri conditional pacing system.

accent cardiac mri study was a prospective, randomized ,multi-center study conducted in asia. subjects indicated for dual-chamber pacemaker and who signed study consent form were considered enrolled and post implant were randomized to either cardiac mri scan group or control group. clinical evaluation and device interrogation were performed at baseline, pre- and post-mri scan, and one month post-mri for all subjects. at 9-12 weeks post-implant, patients in cardiac mri scan group underwent an elective non-diagnostic cardiac mri scan at 1.5 tesla (t) while patients in control group underwent device interrogation and clinical evaluation twice with a 45-minute waiting period in between. the safety endpoint was freedom from mri-related complications while efficacy endpoint was change in right atrial/ ventricular (ra/rv) capture threshold and sensing amplitude from pre-mri scan to one month post-mri scan.

Eligibility criteria:
inclusion criteria * have an approved indication per american college of cardiology(acc)/ american heart association(aha)/ heart rhythm society(hrs)/ european society of cardiology(esc) guidelines for implantation of a pacemaker * will receive a new dual chamber pacemaker and leads * be willing to undergo an elective mri scan without complete sedation, that is ,under consciousness during mri scan * be able to provide informed consent for study participation * be willing and able to comply with the prescribed follow-up tests and schedule of evaluations * is not contraindicated for an mri scan (per the pre-mri safety screening form) * age≥18 years * subjects must be able to undergo pectoral implantation exclusion criteria * having an existing pacemaker or implantable cardioverter defibrillator (icd) .a new pacemaker and lead is required for enrollment * permanent atrial fibrillation/flutter * are medically indicated for an mri scan at the time of enrollment * have an existing active implanted medical device, e.g. neurostimulator, infusion pump etc * have a non-mri compatible device or material implanted * have a lead extender or adaptor * be unable to fit in mri bore; will come into contact with the magnet façade inside the mri bore * are currently participating in a clinical investigation that includes an active treatment arm * are allergic to dexamethasone sodium phosphate(dsp) * are pregnant or planning to become pregnant during the duration of the study * have a life expectancy of less than 12 months due to any condition * subjects with exclusion criteria required by local law (e.g. age) * are unable to comply with the follow up schedule

Keywords: bradycardia mri conditional pacemaker st jude medical accent mri pacemaker tendril mri lead
ravulizumab in adult participants with paroxysmal nocturnal hemoglobinuria currently treated with high-dose eculizumab

Conditions: Paroxysmal Nocturnal Hemoglobinuria

Summary: the primary purpose of this study is to assess the safety, efficacy, pharmacokinetics, and pharmacodynamics of ravulizumab in participants who are prescribed and are receiving a higher than approved dose of eculizumab to treat paroxysmal nocturnal hemoglobinuria (pnh).


Eligibility criteria:
key inclusion criteria: 1. documented diagnosis of pnh, confirmed by high-sensitivity flow cytometry evaluation of red blood cells and white blood cells, with granulocyte or monocyte clone size of ≥ 5%. 2. received 1200 mg eculizumab every 12 to 16 days (every 2 weeks) for at least 3 months prior to screening. 3. ldh ≤ 2 x upper limit of normal (uln) according to central laboratory, at screening. 4. to reduce the risk of meningococcal infection (neisseria meningitidis), all participants must be vaccinated against meningococcal infections within 3 years prior to initiating study drug. 5. body weight ≥ 40 kilograms. key exclusion criteria: 1. history of major adverse vascular events within 6 months of day 1. 2. history of bone marrow transplantation. 3. lymphoma, leukemia, myelodysplastic syndrome, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years. 4. concomitant use of anticoagulants is prohibited if not on a stable regimen for at least 2 weeks prior to day 1. 5. concomitant use of any of the following medications and not on a stable regimen (as judged by the investigator) for the time period indicated prior to screening: * erythropoietin or immunosuppressants for at least 8 weeks * systemic corticosteroids for at least 4 weeks * vitamin k antagonists (for example, warfarin) with a stable international normalized ratio level for at least 4 weeks * iron supplements or folic acid for 4 weeks 6. live vaccine(s) within 1 month prior to screening or plans to receive such vaccines during the study. 7. more than 1 ldh value \> 2 × uln within the 6 months prior to day 1. 8. platelet count \< 30,000/cubic millimeter (30 × 10\^9/liter \[l\]) at screening. 9. absolute neutrophil count \< 500/microliter (0.5 × 10\^9/l) at screening.

Keywords: paroxysmal nocturnal hemoglobinuria pnh ravulizumab ultomiris eculizumab soliris
efficacy and safety of clevudine compared with adefovir in patients with hbeag positive chronic hepatitis due to hepatitis b virus

Conditions: Chronic Hepatitis; Hepatitis B

Summary: the objectives of this study are to compare in nucleoside treatment-naïve subjects, the efficacy and safety of clevudine 30 mg once daily versus adefovir 10 mg once daily, each as monotherapy, for 48 weeks and 96 weeks.


Eligibility criteria:
inclusion criteria: * nucleoside treatment-naïve subjects of either gender, females who are non-pregnant and non-lactating, aged 16 years or older (or the legal age of consent as allowed by local regulations), with compensated hepatic function despite a diagnosis of chronic hbeag positive hepatitis b infection (i.e., based on serological, virological and histological markers) will be eligible for this study. * subjects with historical biopsies used for entry will have chronic hepatic inflammatory injury at screening (knodell hai score ≥ 4 and modified ishak fibrosis score ≤ 5). if applicable, subjects must cease previous treatment with any form of alpha interferon 12 months prior to baseline. * for eligibility, subjects must meet the laboratory criteria for total bilirubin, prothrombin time, serum albumin, platelet count, absolute neutrophil count, ana titer and have a creatinine clearance of ≥ 50 ml/min. exclusion criteria: * subjects participating in a clinical trial or receiving an investigational agent for any reason within 60 days of baseline will be excluded. * subjects with clinically significant concomitant diseases will be excluded.

Keywords: hepatitis b virus nucleoside treatment-naïve patients with hbeag positive
cardiac steatosis in cushing's syndrome

Conditions: Endocrine System Disease; Cardiovascular Imaging

Summary: this study aims at evaluating the myocardial triglyceride content and cardiac structure and function, using 1h magnetic resonance spectroscopy and cardiac magnetic resonance imaging, in patients with cushing's syndrome before and after treatment and in age-, sex- and bmi-matched healthy volunteers. the investigators make the hypothesis that cushing's syndrome patients compared to healthy subjects present with excess lipid storage in cardiac myocytes, reversible upon correction of hypercortisolism.

despite skeletal muscle atrophy, cushing's syndrome patients have an increased left ventricular mass, reversible upon correction of the hypercortisolism. this may be due to cardiac steatosis, previously demonstrated in patients with diabetes mellitus. this study aims at evaluating the myocardial triglyceride content and cardiac structure and function, using 1h magnetic resonance spectroscopy and cardiac magnetic resonance imaging (cmri), in patients with cushing's syndrome and in age-, sex- and bmi-matched healthy volunteers. the patients will be stratified into two groups in function of the presence or absence of diabetes mellitus or impaired glucose and will be evaluated twice: before and 6 months after efficient treatment of cushing's syndrome. we make the hypothesis that cushing's syndrome patients compared to healthy subjects have excess lipid storage in cardiac myocytes irrespectively of the glucose homeostasis status, and that this lipid content will decrease after the correction of hypercortisolism.

Eligibility criteria:
inclusion criteria: * group 1 and 2: patients with overt cushing's syndrome, with 24-hour urinary free cortisol excretion over the two fold of the upper limit of the normal, with (group 1) or without (group 2) diabetes mellitus or glucose intolerance * group 3: healthy volunteers matched for age, sex and bmi with the patients of the group 2 exclusion criteria: * contraindication of mri * hypersensitivity to gadolinium * acute myocardial ischemia * renal insufficiency (creatinin clearance 30 ml/min/l,73m2) * pregnancy

Keywords: cushing's syndrome cardiac steatosis intramyocardial triglyceride content 1h magnetic resonance spectroscopy and cardiac magnetic resonance imaging left ventricularly hypertrophy
outcomes of proactive management of children with myelomeningocele

Conditions: Urologic Diseases

Summary: spina bifida birth prevalence in africa is 0.13%. myelomeningocele (mmc) represents the most frequent and most severe cause of nb in children. treatment of neuropathic bladder secondary to spina bifida is an ongoing challenge. damage of the renal parenchyma in children with nb is preventable given adequate evaluation, follow-up and proactive management. proactive management was defined as use of clean intermittent catheterization (cic), and/or anticholinergics at presentation, or based on initial high-risk urodynamic findings by 1 year of age. the proactive approach to treat sb (cic and pharmacotherapy) has contributed to decreasing chronic kidney disease (ckd). myelomeningocele is considered a complex congenital disease. hence, a multidisciplinary team is the best choice for management of spina bifida, involving neurosurgeons, orthopedic surgeons, urologists, physical medicine and rehabilitation specialists and pediatricians. currently, children with spina bifida in egypt must visit multiple different locations to access the complex care they need. here, we review our experience with patients with spina bifida who will be followed with this team with an emphasis on patients' upper urinary tract protection and decreasing urinary incontinence.


Eligibility criteria:
inclusion criteria: * all patients with myelomeningocele attending assiut university urology hospital. exclusion criteria: * associated other urological congenital anomalies (e.g., puv or bladder exstrophy)

Keywords: myelomeningocele
fit for function: a community wellness program for persons with stroke

Conditions: Stroke

Summary: the purpose of this study is to evaluate whether persons with stroke participating in a 12-week community based wellness program for persons who have had a stroke, experience improved mobility (6 minute walk test), balance, (the short portable performance test and timed up and go), strength (jamar hand grip dynamometry), level of physical activity (rapid assessment of physical activity), reintegration in community (reintegration into normal living index), self efficacy (patient activation measure) and quality of life (stroke specific quality of life scale) compared to persons who do not participate in the program.

the program will be delivered through a partnership between hamilton health sciences, the ymca and mcmaster university. participants will attend the ymca for exercise sessions several times a week and receive education on how to take care of themselves after a stroke. the staff who will deliver the program will have specialized training on how to help people with stroke to exercise safely and effectively. control group participants will be provided with ymca memberships but will not have access to stroke specific education and group exercise classes. staff assisting the control group will be trained in safety and contraindications after stroke, but will not receive the additional specialized training in exercise/education programs for persons with stroke.

Eligibility criteria:
inclusion criteria: * adults ≥18years * living in the community * able to ambulate ≥10 meters with or without an assistive device * able to tolerate 60 minutes activity with rest intervals * have clearance from a physician to participate in the program * can independently follow instructions * are not involved in active rehabilitation exclusion criteria: * musculoskeletal contraindications to exercise * unstable cardiovascular conditions * unstable medical conditions * significant cognitive impairment

Keywords: stroke exercise physical function community program patient education self-management