Kornimate/medical-research-clean huggingface dataset:
rationale and trial design of pfb-03 study: diagnostic performance and clinical application of 18f-fapi-pet/ct for detecting axillary lymph node metastasis in breast cancer patients after neoadjuvant therapy

Conditions: Breast Cancer

Summary: axillary lymph node (aln) status is a crucial prognostic factor in breast cancer. accurate, non-invasive methods for evaluating axillary lymph node metastasis after neoadjuvant therapy (nat) are needed to optimize surgical decisions and minimize patient morbidity. fibroblast activation protein inhibitor (fapi) pet/ct targets cancer-associated fibroblasts and may improve diagnostic accuracy. this study aims to assess the diagnostic performance and clinical utility of 18f-fapi pet/ct in detecting aln metastasis after nat in breast cancer patients. this prospective, single-center study will enroll breast cancer patients with ct1-4n0-1m0 stage before nat, who will undergo pre-surgical 18f-fapi pet/ct followed by sentinel lymph node biopsy (slnb) or axillary lymph node dissection (alnd) guided by protocol stratification based on fapi pet/ct and clinical findings. the primary endpoint is the diagnostic accuracy of 18f-fapi pet/ct for aln metastasis versus pathology. secondary endpoints include false-negative rates (fnr) of slnb, lymphedema rates, and long-term outcomes such as local recurrence and survival rates.


Eligibility criteria:
inclusion criteria: * must provide written informed consent * female at 18-80 years of age * eastern cooperative oncology group (ecog) performance status of 0-1 * with anticipated survival of at least 36 months * pathologically confirmed invasive breast cancer with clinical stage of t1-4n0-1m0 * received standard nat for bc (including either neoadjuvant chemotherapy or neoadjuvant targeted therapy, or a combination) * have willingness to take the 18f-fapi pet/ct imaging * with adequate organ function (neutrophil count ≥ 1.5 × 10⁹/l; platelet count ≥ 90 × 10⁹/l; hemoglobin ≥ 90 g/l; total bilirubin ≤ 1.5 × upper limit of normal \[uln\]; alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤ 2.5 × uln; blood urea nitrogen (bun) and serum creatinine (cr) ≤ 1.5 × uln; international normalized ratio (inr) ≤ 1.5 × uln, activated partial thromboplastin time (aptt) ≤ 1.5 × uln). exclusion criteria: * evidence of distant metastatic disease (m1) * pregnant or lactating women * failure to complete the planned nat * prior surgical intervention in the ipsilateral axilla * diagnosis of any other malignancy within the past 5 years (exceptions: adequately treated non-melanoma skin cancer, cervical carcinoma in situ, papillary thyroid cancer) * known hypersensitivity to the fapi tracer or any excipients * with any serious uncontrolled medical condition that would make the patient unsuitable for surgery or pet/ct (e.g. unstable cardiac disease, severe claustrophobia unresponsive to anxiolytics, renal failure preventing ct contrast if needed) * failure to lie still for imaging (about 20-30 minutes) or adhere to follow-up due to psychiatric, cognitive, or social reasons.
epigenetics and gut microbiota in children with epilepsy

Conditions: Epilepsy

Summary: the ketogenic diet is a high-fat, low-carbohydrate diet used in the treatment of epilepsy. the diet can be an efficient treatment option in children with drug resistant epilepsy, with more than 50 % seizure reduction in about 40- 70 % of the patients. however, there is still a lack of knowledge regarding the mechanisms of action, how will respond to the treatment and potential adverse effects.

the ketogenic diet is a high-fat, moderate protein, low-carbohydrate diet. it is an internationally established treatment option in children with drug resistant epilepsy. about 40 -70 % of children with drug resistant epilepsy treated with the ketogenic diet achieve \> 50 % seizure reduction. however, even though the ketogenic diet has been used in the treatment of epilepsy for almost a century, little is known about how the dietary treatment reduces seizures and which patients that will respond well. in addition, there is limited knowledge about potential adverse effects of the treatment. this is a prospective study following the patients from 4 weeks before initiating the ketogenic diet and during the treatment. the influence of the dietary treatment on the gut microbiota, epigenetics, quality of life, and adverse effects will be investigated.

Eligibility criteria:
inclusion criteria: * drug resistant epilepsy * age 2- 17 years * two or more countable seizures/week * willing to try treatment with the ketogenic diet for at least 12 weeks exclusion criteria: * glucose transporter protein 1 deficiency, pyruvate dehydrogenase deficiency, or pyruvate carboxylase deficiency * known or suspected disease in wich the diet is contraindicated * epilepsy surgery the last 6 months before diet initiation * steroid medications the last 2 months before diet initiation * breastfeeding * psychogenic non-epileptic seizures * eating disorder * pregnancy or planed pregnancy * feeding disabilities not compatible with dietary treatment * inability to follow study scheme * previous treatment with high-fat, low- carbohydrate diet * medical need to start dietary treatment immediately
effect of empagliflozin kinetics on renal glucose reabsorption in patients with type ii diabetes and healthy controls

Conditions: Diabetes Mellitus, Type 2; Healthy

Summary: single center, 14-day, open-label trial to examine the effect of 25 mg q.d. empagliflozin on kinetics of renal glucose reabsorption in patients diagnosed with type 2 diabetes mellitus and healthy controls


Eligibility criteria:
inclusion criteria: 1. t2dm patients and healthy controls aged =18 to \<70 at visit 1. 2. patients diagnosed with t2dm according to the american diabetes association criteria prior to informed consent who are drug-naïve 3. t2dm patients on a stable dose of allowed concomitant medications (as determined by investigator) for 30 days prior to entering the study. 4. t2dm patients with hba1c between \>7 and \ 53 mmol/mol and \<86 mmol/mol) at visit exclusion criteria: 1. patients with type 1 diabetes mellitus. 2. patients with uncontrolled hyperglycemia with a fasting plasma glucose level greater than 240 mg/dl after an overnight fast. 3. patients with a history of clinically significant heart disease (new york heart classification greater than class 3; more than non-specific st-t wave changes on the ecg), peripheral vascular disease (history of claudication), or pulmonary disease as determined by investigator. 4. medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years.
oral versus vaginal progesterone in the luteal support in cryo-warmed embryo transfer cycles

Conditions: Sterility; Infertility

Summary: in ivf/icsi cycles, the progesterone levels induced by ovarian stimulation are low, therefore the luteal phase is supported by progesterone. the use of progestogens in ivf is associated with an improvement in the live birth rate standard protocol for luteal phase support has not yet been established. currently vaginal progesterone is widely used, since the classic oral progesterone seems to result in a low bioavailability and a lower pregnancy rate. however, vaginal administration of progesterone is associated with vaginal irritation, discharge and bleeding. for all these reasons, there is a need for an effective, well tolerated, and safe treatment that can improve patient satisfaction and compliance. many studies have observed similar pregnancy rate results with dydrogesterone and micronized vaginal progesterone. a new rct including a total of 1143 patients by tournaye, showed that dydrogesterone treatment had a similar safety profile to micronized vaginal progesterone (mvp) for luteal support as part of art treatment. the crude pregnancy rates at 12 weeks were 37.6% and 33.1% in the dydrogesterone and mvp treatment groups respectively. regarding the administration route of progesterone, intramuscular and transvaginal routes are the two conventional progesterone administration techniques. however, very few studies have compared the advantages of oral dydrogestrone with vaginal progesterone for luteal support in art cycles. the objective of the investigator's study is to demonstrate the superiority of oral dydrogesterone (duphaston) 10 over mvp (utrogestan) used for luteal supplementation in cryo-warmed embryo transfer cycles. upon consent, 224 patients women will be randomly allocated into either one of the study groups using a simple randomization method by computer-generated random numbers. group i will receive the oral dydrogesterone, while group ii will receive the vaginal microprogesterone.


Eligibility criteria:
inclusion criteria: * normal uterine cavity * normal hormonal investigation: tsh,prl,fbs * frozen embryo transfer cycles: at least 2 embryos * primary or secondary infertility: tubal occlusion, male factor, unexplained, endometriosis, ovarian factors... * body mass index (bmi) ≥18 to ≤30 kg/m2 exclusion criteria: * preexisting untreated medical condition (thyroid disease, diabetes mellitus, hypertension, pulmonary conditions, cardiac condition...) * history of three or more consecutively failed in vitro fertilization (ivf) cycles after embryo transfer * history of three or more miscarriages * previous allergy reactions to progesterone products

Keywords: luteal phase support cryo-warmed embryo transfer assisted reproductive technology
acceptability, feasibility and preliminary efficacy of cfwp to treat clinically elevated fatigue in adults with cf

Conditions: Cystic Fibrosis; Fatigue

Summary: this research is being done to learn more ways to treat non-respiratory symptoms in people with cf including fatigue, pain, mood, sleep problems and the use of a wellness program to treat them.

this study aims to test the acceptability, feasibility and preliminary efficacy of a tailored intervention known as the cf wellness program (cfwp) to treat clinically elevated fatigue in adults with cf. this is a pre-post pilot intervention study of the cf-wellness program. this study is needed because fatigue negatively affects health-related quality of life and has been identified by those with cf as a symptom that needs to be addressed. the study will include approximately 50 participants and the intervention will last approximately 13 weeks.

Eligibility criteria:
inclusion criteria: * ≥18 years old * documentation of cf diagnosis in the medical record * if prescribed a modulator (i.e., ivacaftor, lumacaftor/ivacaftor, tezacaftor/ivacaftor, \& elexacaftor/tezacaftor/ivacaftor), have been on treatment for at least 4 weeks * if prescribed medicine for psychiatric purpose, must be on treatment for at least 8 weeks * has access to a smartphone, tablet, and/or computer with access to internet * ability to understand/read/speak english * receives cf care at a participating cf center * has a score of \>4 on the fatigue severity scale * not likely to start and/or change modulator treatments during the intervention period exclusion criteria: * receiving antibiotic treatment for a pulmonary exacerbation 14 days prior to the screening or expected to start within 14 days after screening visit * is pregnant or less than 6 months postpartum (self-reported) * is currently participating in another interventional trial * contraindication for aerobic exercise (determined by treating physician including cardiovascular, pulmonary and/or musculoskeletal contraindications) * forced expiratory volume in 1 second percent predicted (fev1pp) is \<25% within last year * planning to transfer care to a non-participating cf center before the post-intervention visit could be completed * will not be available to complete cf-wellness sessions in a timely fashion (e.g., will be on extended travel) * has already participated in the cf wellness program
anti-angiogenesis agent ag-013736 in patients with metastatic melanoma

Conditions: Melanoma; Skin Neoplasms

Summary: this is a phase 2 study being conducted at multiple centers in the united states and france. patients having melanoma that has spread to other parts of the body (i.e., metastatic) are eligible to participate. patients must have disease that has been treated with no more than 1 prior treatment for metastatic disease (prior adjuvant treatment for localized disease does not count as prior treatment for metastatic disease). the purpose of the study is to test whether the angiogenesis inhibitor ag-013736 is an effective treatment for metastatic melanoma as shown by the number of patients in the study who experience significant and durable tumor shrinkage.


Eligibility criteria:
inclusion criteria: * histologically documented melanoma with metastases * no more than 1 prior systemic therapy for metastatic disease (prior adjuvant therapy with interferon does not count as prior therapy for metastatic disease) exclusion criteria: * history of hemoptysis (coughing up of blood) * brain metastases

Keywords: melanoma antiangiogenesis
outcomes of mitral valve surgery in patients affected by rheumatic heart disease

Conditions: Outcomes of Mitral Valve Surgery in Patients Affected by Rheumatic Heart Disease

Summary: rheumatic heart disease remains the majority valvular disease in low and middle income countries, which mostly affected mitral valve, surgical treatment is the most effective strategy to improve the outcomes of middle or late-stage rhd patient, however, whether mitral valve repair surgery is superior to replacement or other evolving interventional device remains controversial, this study aims to investigate the results of repair surgery compared with replacement or other treatment strategy from international multicenters.


Eligibility criteria:
inclusion criteria: * 1、rheumatic heart disease 2、mitral valve disease 3、combined with other heart valve disease(aortic valve, tricuspid valve, pulmonary valve) 4、patients underwent initial mitral valve surgery or intervention exclusion criteria: * 1、congenital heart disease degenerative heart valve disease 2、isolated aortic valve or tricuspid valve, pulmonary valve disease( doesn't affect mitral valve ) 3、patients received more than 1 time mitral valve operation

Keywords: rheumtic heart disease mitral valve surgery
multiparametric characterization of orbital tumors by mri

Conditions: Orbital Tumors

Summary: prospective study on patients with orbital tumors of unknown origin. aim of the study is to differentiate benign from malignant tumors upon mr imaging. magnetic resonance imaging of the orbit will be performed including standard morphological sequences and advanced sequence techniques. these advanced sequence techniques may allow to differentiate benign from malignant tumors based on their cellularity and vascularity (diffusion and perfusion imaging). these mri data will be analysed and the level of diffusion and perfusion will be measured and compared to the histological findings. cut-off values of diffusion and perfusion will be calculated that allow to separate benign from malignant tumors.


Eligibility criteria:
inclusion criteria: * non-diagnosed orbital tumors exclusion criteria: * any metal implants, non-mri compatible * age below 18 * pregnancy * recent surgery * recent severe medical diseases
a stress reduction program for companies

Conditions: Stress

Summary: this protocol proposes a well-being program based in stress reduction program for employees of a company. objectives: to evaluate the effects of a stress reduction program with a specific orientation for workers and taught to them within their companies. methods: participants with stress complaints were recruited and randomized into two groups: group 1 (g1) received the intervention while group 2 (g2) did not. both groups were evaluated before the intervention (time 1 - t1); again after the eight weeks of the program for g1 (time 2 - t2); and then at the end of a second eight-week period during which g2 received the intervention and g1 was simply instructed to maintain the practice they had learned without further instruction (time 3- t3).

disorders resulting from chronic stress are some of the main causes of absenteeism and reduced productivity in companies. a number of successful stress management programs are based on the principle of mindfulness and may help individuals to relieve stress symptoms and to improve well-being and pro-social behavior. the objective of this study was to evaluate the feasibility and efficacy of a weekly one-hour stress reduction program adapted for companies and if the possible benefits would be sustained 8 weeks after the end of the program. participants with stress complaints were recruited in two companies and they were randomized into two groups: in the first period of the study, group 1 (g1) n=23 received the intervention while group 2 (g2) n=18 did not. both groups were evaluated before the intervention (time 1 - t1); again after the eight weeks of the program for g1 (time 2 - t2); and then at the end of a second eight-week period during which g2 received the intervention and g1 was simply instructed to maintain the practice they had learned without further instruction (time 3- t3).

Eligibility criteria:
inclusion criteria: * workers with stress complaints aging from 18 to 60 years. they also had to have at least 8 years of education. exclusion criteria: * participants with a history of psychiatric or neurological disorders or who were under psychological or psychiatric treatment during the period of the study, or with a history of substance abuse, with the exception of tobacco.

Keywords: stress work employees mindfulness depression anxiety
patient reported outcomes after surgery for rectal endometriosis

Conditions: Endometriosis; Endometriosis, Rectum; Endometriosis-related Pain; Endometriosis; Bowel

Summary: to describe the difference in patient reported outcomes after conservative treatment in comparison to radical rectal surgery in patients with deep endometriosis infiltrating the rectum (up to 15cm from the anus with at least involvement of the muscularis layer) and to determine predictors for radical surgery.


Eligibility criteria:
inclusion criteria: * age: 18 - 45 years (both inclusive) * bmi \<35 * complaining of infertility and/or pain * deep endometriosis infiltrating the rectum on at least one imaging technique up to 15 cm from the anus and involving at least the muscularis layer in depth exclusion criteria: * refusal of bowel resection/stoma * history of laparotomy for endometriosis * (history of) hysterectomy * suspected pelvic malignancy * pregnancy * impossibility for postoperative follow-up in our hospital
falls prevention in older home care recipients

Conditions: Accidental Falls

Summary: the aim of this study is to investigate the effect of a falls-prevention exercise programme on health-related quality of life, fear of falling, falls and physical function in older people receiving home care. participants in the intervention group perform the otago exercise programme. participants in the control group continue their usual activities.

falls and falls-related injuries are considered a serious public health issue in the older population. strength and balance exercise in combination with information about falls prevention seems to be effective in reducing falls, but less is known about the effect of this kind of intervention on quality of life. this randomized controlled trial investigates the effect of a falls prevention program on health-related quality of life, fear of falling, falls and physical function in community-dwelling older people who receive home care.

Eligibility criteria:
inclusion criteria: * has fallen at least one time in the last 12 months * receives home-help services * able to walk independently indoors with or without walking aid exclusion criteria: * medical contraindication to exercise * life expectancy \<1 year * scores under 23 points on mini mental scale examination * participating in another falls prevention programme during the 12 weeks of the programme, for example a falls prevention group

Keywords: falls home care older people falls prevention quality of life exercise balance preventative care community health services home-help services
pradaxa (dabigatran etexilate 220 mg/q.d. in the general population after hip or knee replacement surgery

Conditions: Arthroplasty, Replacement; Thromboembolism

Summary: an observational cohort study on safety and efficacy of the 220 mg dose pradaxa to generate additional data in predefined sub populations of patients at increased risk of bleeding or vte


Eligibility criteria:
inclusion criteria: patients of 18 years of age or above undergoing elective total hip or knee replacement surgery who consent in writing to their participation in this observational study exclusion criteria: all patients who should not be treated with pradaxa 220 mg according to the european summary of product characteristics (spc): age of \> 75 years, renal impairment (creatinine clearance \ 2 upper limit of normal (uln) and/or hepatic impairment or liver disease expected to have any impact on survival, anaesthesia with post operative indwelling epidural catheters, hypersensitivity to dabigatran etexilate or to any of the excipients, active clinically significant bleeding, organic lesion at risk of bleeding, spontaneous or pharmacological impairment of haemostasis except for the above included patients groups, concomitant treatment with quinidine
multidisciplinary approach to nutritional support for oncological patients - nutracare project

Conditions: Gastrointestinal Neoplasms

Summary: malnutrition correlated to increased perioperative morbidity occurs in patients with gastrointestinal malignancies. adherence guidelines for nutritional assessment and support in oncological patients is unfortunately very low. the aim of the study is to improve clinical practice by using and testing the digital platform nutracare in 5 different centers.

after being informed about the study, all the patients undergoing elective surgery or first cycle of neoadjuvant or adjuvant therapy giving written informed consent will be screened by the surgeon or the oncologist and the nrs-2002 (nutrition risk screening) will be administered. patients who will be assessed at risk will be notified to the center nutritionist.

Eligibility criteria:
inclusion criteria: * \<18 years * ecog grade 0-2 * patients undergoing elective surgery or first cycle of chemotherapy (neoadjuvant or adjuvant) for staged i-iii colorectal, hepatobiliary-pancreatic and oesophago-gastric cancers exclusion criteria: * \>18 years * pregnancy * emergency * ecog ≥ 3 * m+ * peritoneal involvement * inability to provide informed consent * informed consent refusal
the role of local tranexamic acid on periorbital oculoplastic surgery

Conditions: Eyelid Diseases; Periorbital Disorder; Hemorrhage; Surgical Blood Loss

Summary: this study investigates the effect of tranexamic acid, a medication that helps reduce bleeding, in patients undergoing surgeries around their eyes.


Eligibility criteria:
inclusion criteria: * adults age 18 and above undergoing periorbital oculoplastic surgery including but not limited to upper and lower blepharoplasty, four lid procedures, or dacryocystorhinostomy (dcr). exclusion criteria: * - adults unable to consent * individuals less than 18 years of age * prisoners * pregnant women. * known contradictions or sensitivities to study medication (tranexamic acid) * patients with known prior thromboembolic events * previous eyelid surgery or same-side dcr (re-dcr) * has any type of coagulopathy