Kornimate/medical-research-clean huggingface dataset:
radiation omission in patients with her2 overexpressing tumors with pathologic complete response

Conditions: Breast Cancer; HER2-positive Breast Cancer

Summary: the purpose of this study is to evaluate the feasibility, based on recruitment rate over a 3-year period, of enrolling patients for the omission of post-operative breast radiation following breast conserving surgery and sentinel node biopsy or axillary lymph node dissection in women with her2+ breast cancer who achieve pathologic complete response.


Eligibility criteria:
inclusion criteria: * female * age ≥ 40 years * patients must have a tissue diagnosis of her2+ breast cancer * patients must have documented clinical t1-3, n0, m0 disease prior to receiving neo-adjuvant chemotherapy * patients must have undergone neo-adjuvant chemotherapy and targeted her2 therapy prior to surgery and plan for completion of adjuvant systemic therapy as directed by their medical oncologist * patients must have completed partial mastectomy/lumpectomy and sentinel node biopsy or axillary node dissection. * patient must have documented pathologic complete response (defined as no residual invasive or in situ disease in the breast or axilla, including free of isolated tumor cells or micrometastasis) exclusion criteria: * breastfeeding * prior history of breast cancer (invasive or ductal carcinoma in-situ) in either breast * prior adjuvant radiation therapy * patients with diagnosis of inflammatory breast cancer * patients with known brca mutation or other known breast cancer related deleterious mutations

Keywords: her2 partial mastectomy lumpectomy sentinel node biopsy axillary node dissection pathologic complete response breast cancer her2-positive
adult congenital heart disease surgery

Conditions: Congenital Disorders

Summary: it is now estimated that the number of adults with congenital heart disease in the u.s is over 800,000. unfortunately, these patients, in some way, have become a lost population. they have congenital abnormalities familiar to a children's hospital, yet have surpassed the age cutoff for admission. recently, we have developed a specialized program to care for this unique patient population. dedicated programs such as ours hope to optimize patient care, consolidate specialized resources, provide sufficient patient numbers for training and maintain expertise and facilitate research in this unique population.

in the united states, approximately 30,000 children are born with congenital heart disease every year. as technology, operative technique, and critical care medicine have improved significantly over the years, more of these children are surviving into adulthood. care of the congenital cardiac surgical patient requires a concerted effort on the part of the surgeons, perfusionists, anesthesiologists, intensivists, nurses, respiratory therapists, rehabilitation services and social workers. it is hoped that the same excellent care received in a children's congenital heart surgery program can be continued as these patients graduate into an adult program. this is a retrospective chart review examining patients over the age of 18 years who have undergone operations for congenital heart disease. the primary interest of the study is to look at the breakdown of our adult congenital program in regards to location, personnel, and case type. all charts reviewed will be of patients who had their surgery at children's healthcare of atlanta or emory university between january 1, 2000 and december 31, 2006. we will review approximately 225 charts for this study. the first aim of the study would be to examine the demographics of the adult congenital heart surgery program itself. the following information will be collected: * location of the surgery - children's hospital vs adult hospital * surgeon - adult cardiac surgeon vs congenital cardiac surgeon the second aim of the study would be to analyze the types of surgeries being performed. the following information will be collected: * pathologic diagnosis * number of re-operative sternotomies * number of open-heart surgeries the third aim of the study would be to analyze our outcomes. the following information will be collected: - number of surgical mortalities

Eligibility criteria:
inclusion criteria: * surgery at children's healthcare of atlanta or emory university between 1.1.2000 and 12.31.2007 * surgery on patients after 18 years to approximately 65 years of age exclusion criteria: * those who do not meet inclusion criteria

Keywords: congenital heart disease surgery adult
to evaluate safety, pharmacokinetics and pharmacodynamics of medi6012 in subjects with stable coronary artery disease

Conditions: Coronary Artery Disease

Summary: this is a phase 2a randomized, double-blind (subject/investigator blinded, medimmune unblinded), placebo-controlled, dose-escalation study to evaluate the safety, pk/pd, and immunogenicity of single iv and sc medi6012 doses in adult subjects with stable cad.


Eligibility criteria:
inclusion criteria: * men and women 40 - 75 years old * history of stable cad * currently receiving statin as standard of care exclusion criteria: * severe angina pectoris symptoms * high-risk coronary or carotid artery disease that will likely require surgical or percutaneous intervention during the study period * hospitalization for heart failure within 12 months prior to screening * uncontrolled hypertension * within 6 months prior to screening, a history of acs or hospitalization for heart failure * clinically significant abnormalities in rhythm, conduction or morphology of ecg * subjects with transplanted heart, left ventricular assist device, implanted pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy * untreated life-threatening ventricular arrhythmias * history, within 12 months prior to screening, of myocarditis or restrictive pericarditis, or hemodynamically significant valvular hear disease or aortic disease * undergone major surgery with in 3 months prior to screening or has planned major surgery during the study period

Keywords: coronary artery disease cad
effects of lipemia and metformin on endothelial function

Conditions: Cardiovascular Disease

Summary: eating a diet high in fat contributes to the development of atherosclerosis (hardening of the arteries). acute fat consumption increases levels of fat in the blood and temporarily reduces the ability of blood vessel to dilate (open up to carry additional blood). a similar response is observed during infusion of intra-lipid (a fat emulsion used for intravenous nutrition). the present study is designed to help us understand the effects of a fat load on blood vessel function. we will measure arterial dilation using non-invasive techniques before and at the end of a 5-hour infusion of intra-lipid in healthy subjects. subjects will then take the approved drug metformin for two weeks and return for repeat studies of endothelial function with intra-lipid infusion. we expect that metformin will help preserve the normal function of blood vessels during a fat load. this study will help us understand how fat affects blood vessels and therefore will advance our knowledge of the development of atherosclerosis and potentially lead to improved methods to prevent and treat heart disease.


Eligibility criteria:
inclusion criteria: * healthy volunteers exclusion criteria: * pregnancy (defined as positive urine pregnancy test) * diabetes mellitus (clinical history or random blood glucose\>140 mg/dl) * hypertension (clinical history or sbp\>140 or dbp\>90 mmhg) * history of adverse reaction to metformin * abnormal renal function (serum creatinine\>1.4 mg/dl) * abnormal liver function (ast or alt greater than two times the upper limit of normal) * administration of iodinated contrast within 7 days * history of congestive heart failure * abnormal clotting parameters (inr\>1.5 or ptt\>40 sec) * anemia (hct\<30%) * allergy to soy or egg * allergy to heparin * the potential subject plans to perform heavy exercise in the setting of low calorie intake during the period of the study such as running or competitive road or bicycle racing

Keywords: endothelium cardiovascular disease dietary fat insulin resistance
performance comparison between fanfilcon a and senofilcon a sphere lenses

Conditions: Myopia

Summary: prospective, multi-center, bilateral, double-masked, randomized, cross-over, daily wear, 1 month dispensing study (2 weeks each lens pair)

the aim of this study is to determine the clinical performance of fanfilcon a in comparison to senofilcon a sphere contact lenses.

Eligibility criteria:
inclusion criteria: a person is eligible for inclusion in the study if he/she: * is between 18 and 40 years of age (inclusive) * has read, understood and signed the information consent letter * has had a self-reported eye exam in the last two years * is a spherical soft contact lens wearer * has a contact lens prescription that fits within the available parameters of the study lenses * has a spectacle cylinder no greater than 0.75d (diopters) in each eye * can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logmar) or better in each eye * can achieve a distance visual acuity of 20/30 (0.18 logmar) or better in each eye with the study contact lenses * has clear corneas and no active ocular disease * is willing and anticipated to be able to comply with the wear schedule (8 hours per day; 5 days a week of lens wear) * is willing and able to follow instructions and maintain the appointment schedule exclusion criteria: a person will be excluded from the study if he/she: * has a history of not achieving comfortable cl (contact lens) wear (defined as 5 days per week; \>8 hours/day) * is currently wearing senofilcon c (2 weeks lens), senofilcon a 1-day, senofilcon c (monthly lens) or enfilcon a contact lenses * is habitually using rewetting/ lubricating eye drops more than once per day * presents with clinically significant anterior segment abnormalities * presents with ocular or systemic disease or need of medications which might interfere with contact lens wear * presents with slit lamp findings that would contraindicate contact lens wear such as: * pathological dry eye or associated findings * significant pterygium, pinguecula, or corneal scars within the visual axis * neovascularization \> 0.75 mm in from of the limbus * giant papillary conjunctivitis (gcp) worse than grade 1 * anterior uveitis or iritis (or history in past year) * seborrheic eczema of eyelid region, seborrheic conjunctivitis * history of corneal ulcers or fungal infections * poor personal hygiene * has a known history of corneal hypoesthesia (reduced corneal sensitivity) * has aphakia, keratoconus or a highly irregular cornea * has presbyopia or has dependence on spectacles for near work over the contact lenses * has undergone corneal refractive surgery
rapamycin in combination with low-dose aracytin in elderly acute myeloid leukemia patients

Conditions: Acute Myeloid Leukemia

Summary: these study is designed to evaluate the tolerability and efficacy of sirolimus (rapamycin) in combination with low-dose aracytin in elderly aml.

evaluate the tolerability and efficacy of sirolimus (rapamycin) in combination with low-dose aracytin

Eligibility criteria:
inclusion criteria: * informed consent * de novo or secondary lam (cml excluded) not elligible for intensive chemotherapy. * previously untreated exclusion criteria: * renal impairment (serum creatinin \>2n) * hepatic impairment (tgo ou tgp \> 5n), une cholestase (phosphatases alcalines or gamma-gt \> 5n),bilirubin \> 3n * blast crisis cml * acute promyelocytic leukemia.

Keywords: aml rapamycin elderly elderly patients not eligible for intensive chemotherapy
asprosin in breast cancer

Conditions: Breast Cancer

Summary: to evaluate the clinical utility of asprosin measurement in breast cancer patients in comparison with healthy controls and patients with benign breast lesions. to compare between asprosin and the routine markers (cea, ca15-3) as biomarkers for breast cancer diagnosis


Eligibility criteria:
inclusion criteria: - females aged (40 ± 20 years) who did not receive any chemotherapy or surgical treatment and they will be divided as follow: group 1: healthy controls from healthy volunteers. group 2: patients with benign breast lesions. group 3: breast cancer patients. exclusion criteria: * 1- female patients with any other type of malignant or benign tumors. 2- past history of chemotherapy or surgical treatment of cancer.
effect of a physical-activity-promoting environment on motor skills, physical activity and quality of life of children in childcare settings

Conditions: Obesity; Inactivity

Summary: the purpose of the study is to evaluate the effect of a project promoting unstructured spontaneous physical activity (pa) through an adaptation of the built environment and the provision of a supportive social environment of childcare centers on motor skills, physical activity, desire to move around, body mass index (bmi), quality of life and pa and behavior of the family.

the study will last one school year and includes 58 childcare centers in 3 provinces (ju, ne, vd) of the french part of switzerland.

Eligibility criteria:
inclusion criteria: * children in selected childcare centers

Keywords: childhood obesity children inactivity physical activity motor skills motor fitness quality of life nutrition family
effects of neurodynamic sliding versus eccentric training on lower extremity function, strength and proprioception in athletes with short hamstring syndrome.

Conditions: Hamstring Tightness; Hamstring Injury Prevention

Summary: hamstring strains are among the most common injuries in field sports, accounting for 10% of all team sports injuries and often leading to long-term absence from activities. risk factors include older age, previous injuries, reduced flexibility, and strength deficits. the hamstrings play a critical role in dynamic stability and joint preservation, particularly for the hip and knee. while stretching is crucial for injury prevention, there is debate over optimal techniques. the neurodynamic sliding technique (nst) and eccentric training (et) are two methods that can improve flexibility and reduce injury risk. this study uniquely combines et with nst to address hamstring tightness in athletes, aiming to evaluate their effects individually and in combination on knee muscle strength, range of motion, proprioception, and lower limb function compared to a control group. the hypotheses examine whether these interventions differ in their impact on eccentric and concentric knee strength, the knee flexor/extensor strength ratio, range of motion, proprioception, and dynamic balance (measured via the y balance test). the null hypothesis (h0) proposes no differences, while the alternative hypothesis (h1) suggests significant differences among the intervention methods.


Eligibility criteria:
inclusion criteria: 1. age between 18-30 years old 2. have a normal body mass index (bmi) 3. have hamstring tightness as indicated by the results of an slr examination of less than 75o (39). 4. have hamstring tightness as indicated active knee extension test (aket) was used to evaluate hamstring shortness. individuals with aket angles less than 150 degrees were considered as samples (146). 5. ability to perform exercises. 6. don't having plates (implants) in the lower limbs. 7. not having a history of fracture in the lower limb (with or without realignment process). 8. not having history of surgery to repair joint capsules, ligaments, muscles, and nerves, 9. a history of or experiencing hernia nucleus pulposus (hnp). exclusion criteria: 1. receiving physical therapy or other conventional therapy in the past 6 months. 2. absence in one of the pre- or post-test sessions. 3. absence of more than two sessions in practice sessions.

Keywords: hamstring tightness neurodynamics eccentric exercise
determining whether intra-arterial carboplatin causes hearing loss in children

Conditions: Intraocular Retinoblastoma; Hearing Loss

Summary: the purpose of this study is to find out how often hearing loss occurs in patients with retinoblastoma after receiving treatment with intra-arterial carboplatin.


Eligibility criteria:
inclusion criteria: * signed informed consent indicating awareness of the investigational nature of the protocol. * children with rb aged 3 months and older who are scheduled to receive their first dose of ia carboplatin chemotherapy. * retinoblastoma is rarely seen in children over 8 years old, however we will not include an upper age range so as not to exclude any possible participants exclusion criteria: * children with known and documented preexisting hearing loss.

Keywords: hearing status 18-529
mesenchymal stem cells for treatment of refractory chronic graft-versus-host disease

Conditions: Chronic Graft-versus-host Disease

Summary: the purpose of this study is to evaluate the utility of treating patients experiencing refractory chronic graft-versus-host disease with ex-vivo-expanded bm-drived mesenchymal stem cells from third-party donors. the objective was to evaluate the effect and safety of such treatment on refractory chronic graft-versus-host disease.

allogeneic hematopoietic stem cell transplantation(allo-hsct) can cure many hematologic diseases. although great progress has been made in the prevention and treatment of side effects associated with transplantation,chronic graft-versus-host disease(cgvhd) remains an important complication that occurs in about 50% patients. the mortality of cgvhd and its complication could reach up to 50%,and cgvhd seriously influence the quality of life. at present, glucocorticoids and cyclosporine (csa) are the first line treatment of cgvhd, but their effective rates are only 50%. if first line treatment is ineffective, second line drugs would be taken, such as mycophenolate mofetil(mmf)and rituximab. the effective rates of second line drugs are 30%-61%. the effective rates and prognosis of refractory cgvhd are even worse. mesenchymal stem cells (mscs) are a form of multipotent adult stem cells that can be isolated from bone marrow (bm), adipose tissue, and cord blood. clinical applications of human mscs are evolving rapidly with goals of improving hematopoietic engraftment, preventing and treating gvhd after allo-hsct and so on. however, the efficacy of treatment of refractory cgvhd using expanded bm-derived mscs from a third-party donor is rarely reported. if such treatment could be shown to be effective and safe, bm-derived mscs could potentially be used as an universal donor material. this would have a major impact because the generation of donor-specific mscs is time-consuming, costly, and often impractical if the clinical status of a patient is urgent. in the present study, the investigators will prospectively evaluate the efficacy and safety of ex-vivo-expanded bm-derived mscs from third-party donors in treating patients with refractory cgvhd.

Eligibility criteria:
inclusion criteria: * a patient age of 12-65 years * recipients of allogeneic hematopoietic stem cell transplantation * patients with refractory cgvhd * on a voluntary basis, patients are divided into mscs and non-mscs group * subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study exclusion criteria: * any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) * patients with any conditions not suitable for the trial (investigators' decision)

Keywords: hematopoietic stem cell transplantation mesenchymal stem cells chronic graft-versus-host disease
pain neuroscience education for older adults

Conditions: Chronic Pain

Summary: this study aims to investigate the feasibility of using pain neuroscience education for older adults with chronic pain from primary care services. it will have a group of participants receiving pain neuroscience education and exercise and a group receiving usual care.


Eligibility criteria:
inclusion criteria: * be able to read and write and have chronic pain (defined as pain lasting 3 months or more and felt at least once a week during these 3 months ) anywhere in the body. exclusion criteria: * presence of pathology of the nervous or cardiovascular systems, cancer, or having had a surgery in the last 6 months or the presence of a condition for which the practice of therapeutic exercise could be contraindicated.
acupoint stimulation and cranial endovascular treatment

Conditions: Cerebral Aneurysm

Summary: in this prospective randomized controlled trial, the subjects will be assigned to group transcutaneous electrical acupoint stimulation (teas) and group control (no intervention). the postoperative outcomes including nihss (national institute of health stroke scale) score, morbidity and mortality will be evaluated during hospital stay and by one year after surgery.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years 2. patients scheduled for cranial endovascular treatment exclusion criteria: 1. american society of anesthesiologists class ⅲ or higher 2. hunt-hess class ⅲ or higher 3. body mass index (bmi) \ 30kg/㎡ 4. large or giant cerebral aneurysms with diameters greater than 15mm and minor cerebral aneurysms with diameters less than 3mm 5. posterior circulation infarction 6. recurrence of an cerebral aneurysms after endovascular procedures or surgical clipping 7. severe abnormal coagulation function, severe liver and kidney function damage, or combined with heart and respiratory system failure 8. injury or infection of the skin around the acupoint area 9. participate in other clinical researchers within 3 months 10. history of neurological or psychiatric diseases 11. patients with implanted electrophysiological device 12. use of sedative or analgesics before surgery 13. patients with difficulty in communication

Keywords: transcutaneous electrical acupoint stimulation endovascular treatment
efficacy of minimally invasive approach in the surgical treatment of complex perianal fistula

Conditions: Fistula Perianal

Summary: the goal of this clinical trial is to study whether the minimally invasive approach in the mucosal advancement flap technique for the treatment of complex perianal fistula improves the healing rate compared to non-minimally invasive surgery. the main question it aims to answer is: - does the healing rate of patients undergoing minimally invasive approach in the mucosal advancement flap technique improve compared to patients undergoing non-minimally invasive surgery? researchers will also compare minimally invasive approach in the mucosal advancement flap technique to the non-minimally invasive approach in terms of postoperative pain, fecal incontinence and healing time. quality of life and global morbidity will also be analyzed. participants will: * undergo surgical treatment of complex perianal fistula performed by mucosal advancement flap performed by a minimally invasive technique. * attend control visits and fill in symptom forms one week, one month, three months and six months after the surgical procedure.


Eligibility criteria:
inclusion criteria: * age older than 18. * present with a complex perianal fistula not surgically treated with curative intention. * present only one main fistulous tract. * mucosal advancement flap as the chosen technique for the treatment of the fistula. * patient has given informed consent to participate in the study. exclusion criteria: * non-cryptoglandular internal fistulous orifice (ifo). * extrasphincteric fistula. * coexistence of anal fissure. * coexistence of hemorrhoids tributary to surgery. * coexistence of anal or rectal prolapse. * coexistence of inflammatory bowel disease. * coexistence of anal or colorrectal cancer.

Keywords: perianal fistula mucosal advancement flap minimally invasive approach