Kornimate/medical-research-clean huggingface dataset:
application of "heidelberg triangle" dissection in pancreatoduodenectomy and distal pancreatectomy

Conditions: Pancreatoduodenectomy; Periampullary Carcinoma; Pancreatic Cancer

Summary: aim of the study : to evaluate the effect and safety of "heidelberg triangle" dissection (triangle operation) combined with pancreatoduodenectomy or distal pancreatectomy on the prognosis of pancreatic cancer and periampullary cancer . methods : patients who underwent pancreatoduodenectomy or distal pancreatectomy between 01 september 2016 and 30 december 2022 will be included in this retrospective analysis. 3d reconstruction is performed with preoperative enhanced ct, then the region of "heidelberg triangle" is categorized . the operation is completed by the same operation team. according to the operation mode, patients were divided into triangle group and non-triangle group and and followed up until recurrence, death or missed.

the "heidelberg triangle" is an anatomical area composed of common hepatic artery (cha), superior mesenteric artery (sma) and superior mesenteric vein (smv). this area is considered to be the common site of recurrence after pancreatic surgery. recent studies have shown that triangle operation can improve the state of the cutting edge and has potential value in improving the prognosis. however, the data on recurrence and survival rate of pancreatic cancer and periampullary cancer after triangle operation are insufficient. the aim of the present study is to evaluate the effect and safety of "heidelberg triangle" dissection combined with pancreatoduodenectomy or distal pancreatectomy on the prognosis of pancreatic cancer and periampullary cancer .

Eligibility criteria:
inclusion criteria: 1. patients diagnosed by preoperative imaging and auxiliary examination as resectable or borderline resectable pancreatic malignant tumor or periampullary carcinoma who underwent pancreatoduodenectomy or distal pancreatectomy, with or without triangle operation. 2. patients who have no serious abnormalities of blood system, heart and lung function and immune deficiency and can tolerate surgery. 3. be able to comply with the research visit plan and other program requirements exclusion criteria: 1. patients accompanied by other systemic malignancies. 2. central nervous system disease, mental disease, unstable angina pectoris, congestive heart failure, serious arrhythmia and other uncontrollable serious diseases, unable to tolerate surgery. 3. pregnant and lactating women. 4. any condition that may impair the safety of patients or the integrity of research data, including serious medical risk factors, medical conditions, and laboratory abnormalities.
radiographic and clinical outcomes of puregen in posterior lumbar (plif) and transforaminal interbody fusion (tlif)

Conditions: Lumbar Degenerative Disc Disease

Summary: the purpose of this study is to assess the safety and efficacy of puregen osteoprogenitor cell allograft in patients undergoing posterior lumbar or transforaminal interbody fusion.


Eligibility criteria:
inclusion criteria: * subjects with back and/or leg pain electing to receive transforaminal lumbar interbody fusion (tlif)/ posterior lumbar interbody fusion (plif) procedure and posterior transpedicular stabilization with or without decompression at any level * unresponsive to conservative treatment for at least 6 months * radiographic confirmation of primary diagnosis exclusion criteria: * more than 2 levels requiring lumbar interbody fusion * spondylolisthesis greater than grade i * prior failed fusion surgery at any lumbar level(s) * local or systemic infection past or present * active systemic disease * osteoporosis, osteomalacia, or other metabolic bone disease that would significantly inhibit bone healing * bmi greater than 40 * use of other bone graft, bone morphogenetic protein (bmp) or bone graft substitutes in addition to or in place of those products specified * use of post operative spinal cord stimulator (scs) * any condition requiring postoperative medications that inhibit fusion, such as chronic use of oral or injected steroids or prolonged use of non-steroidal anti-inflammatory drugs * known or suspected history of alcohol and/or drug abuse * involved in pending litigation or worker's compensation related to the spine * pregnant or plans to become pregnant during the course of the study * insulin-dependent diabetes mellitus * known sensitivity to device materials * life expectancy less than duration of study * any significant psychological disturbance that could impair consent process or ability to complete self-assessment questionnaires * undergoing chemotherapy or radiation treatment * known history of hypersensitivity or anaphylactic reaction to dimethyl sulfoxide (dmso)
a study of rc48-adc combination therapies as first-line treatment in advanced metastatic gastric cancer

Conditions: Gastric Cancer

Summary: this is a phase ii/iii, randomized, multicenter, open-label clinical trial designed to evaluate safety and efficacy of rc48-adc combine with toripalimab and chemotherapy or rc48-adc combine with toripalimab and trastuzumab as first-line treatment in human epidermal growth factor receptor 2 (her2)-expression participants with locally advanced or metastatic gastric cancer.

this is a phase ii/iii, randomized, multicenter, open-label clinical trial designed to evaluate safety and efficacy of rc48-adc combine with toripalimab and chemotherapy or rc48-adc combine with toripalimab and trastuzumab as first-line treatment in human epidermal growth factor receptor 2 (her2)-expression participants with locally advanced or metastatic gastric cancer. the her2-expression is defined as: the her2 ihc 3+ or 2+, or 1+.

Eligibility criteria:
inclusion criteria: * voluntary agreement to provide written informed consent. * age:18-70 years（including 18 and 70）. * predicted survival ≥ 12 weeks. * eastern cooperative oncology group (ecog) performance status score of 0 or 1. * adequate organ function. * all subjects must have inoperable, advanced or metastatic gastric or or gastroesophageal adenocarcinoma. * subject must be previously untreated with systemic treatment; subject that received neoadjuvant chemotherapy with recurrence \>6 months from completion of therapy are permitted; * her2-expressing status determined by laboratory to be ihc 1+, 2+ or 3+. exclusion criteria: * active central nervous system (cns) metastases. * known active hepatitis b, active hepatitis c, or human immunodeficiency virus (hiv) infection. * history of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, thyroid cancer ,etal. * known hypersensitivity to antibody-drug conjugate(adc) or pd-(l)1 or any of its components. * assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.

Keywords: rc48-adc her2 expression gastric cancer
protein ingestion and skeletal muscle atrophy

Conditions: Muscle Atrophy

Summary: the effect of different protein intakes on skeletal muscle atrophy during short term unilateral leg immobilisation.


Eligibility criteria:
inclusion criteria: * bmi \>18 and \<28 no prescription medications or current illness. exclusion criteria: * bmi \ 28 current prescription medication no history of leg injury. * smoker * medical conditions including (cardiovascular disease ((e.g. hypertension)), metabolic disease ((e.g. type 2 diabetes)), any personal or family history of deep vein thrombosis.
cast vs splint in distal radius fractures

Conditions: Distal Radius Fracture

Summary: this study will evaluate and compare the efficacy of 2 commonly-used methods of fracture immobilisation: (1) fiberglass cast, and (2) thermoplastic splint. both these devices are externally applied and provide pain relief while immobilising the fracture in an acceptable position. casts and splints are both established devices in routine clinical use.

casts and splints are both established methods of treating drf. casts have been traditionally the gold standard for non-operative care of fractures, but there are distinct disadvantages such as skin rash and pruritus, malodour, skin maceration and loosening as the initial swelling subsides. casts require specialized tools for removal and they have to be reapplied by specialized staff if the casts become loose or wet. splints have the advantage of being removable and therefore facilitate hygiene and provide a better fit because of the adjustable straps. splints are theoretically less rigid and patient non-compliance because of the ease of removal may result in a greater likelihood of fracture displacement. however, it is known that fractures displace even in casts and the efficacy of casts at maintaining reduction over splints has not been established. moreover, it has been clearly shown that the elderly patients have good functional outcomes that do not correlate with the position in which the fracture heals i.e. they tolerated a large degree of fracture malunion (arora; egol). the primary goal of this study is to show that there is no difference in the final functional outcome between distal radius fractures treated non-operatively with splints and casts. the secondary goals are to demonstrate: (1) splinting results in greater patient comfort and acceptance; (2) there is no significant difference in final radiographic outcomes between drf treated with casts and splints; and (3) there is no difference in clinical outcome at the 6-month and 12-month follow-up points. this study is clinically important for several reasons. first, patients may be encouraged to use splints instead of casts if there is no difference in functional outcome and the former provide better comfort. second, patients may not be required to present for long (\>6-month) follow-ups if it can be shown that the clinical improvement plateaus at 6 months after injury. this is consistent with our aim to improve patients' overall quality of life after musculoskeletal injuries and forms a core component of functional ageing.

Eligibility criteria:
inclusion criteria: * closed drf in patients \> 60 years * presenting to hrmc within 10 days of injury * isolated injury * with or without m\&r performed in emd * declined surgical fixation after appropriate discussion exclusion criteria: * wounds - skin tears, bad abrasions, open fracture * ulnar fracture \> styloid * other msk / non-msk injuries * bilateral fractures * prior wrist fractures / wrist surgery * other upper limb conditions affecting function (e.g. cva) * cognitive impairment * allergy to plaster or fiberglass
predictive value of neurovascular coupling in infants with congenital heart disease

Conditions: Congenital Heart Disease; Neurodevelopmental Disorders; Electroencephalography; Near-Infrared Spectroscopy; Biomarkers

Summary: infants with congenital heart disease (chd) are at increased risk for delayed neurodevelopment. multiple etiological explanations have been proposed, as there seems to be a multifactorial interplay of both prenatal and perioperative factors. the main goal of this research project is to focus on peri-operative physiological risk factors in infants with chd which impair functional brain maturation or elicit brain injury, and subsequently creating a risk model and guidelines for standardized developmental follow-up in this population. part 1: investigation of cerebral autoregulation and neurovascular coupling the homeostasis in cerebral blood supply regardless of perfusion pressure, is called cerebral autoregulation (car). neurovascular coupling (nvc) is the phenomenon in which blood supply increases as a result of increased brain activity in a specific area. at different times in the perioperative phase, these regulatory mechanisms will be estimated based on electroencephalography (eeg) and near infrared spectroscopy (nirs), in addition to hemodynamic parameters. part 2: cell-free dna (cfdna) extraction. non-invasive monitoring of neuronal degeneration can be performed using cfdna extraction techniques. serial measurements of neuronal cfdna will be used to determine whether and when this neuronal damage has occurred. part 3: prognosis and outcome. these risk factors, supplemented with demographic factors and medications administered, will be combined in an artificial intelligence-driven model, thus establishing a risk model for neurodevelopmental outcome. this model will be compared to the current standard-of-care, both structural imaging (ultrasound and mri) and a clinical developmental assessment at 9 and 24 months of age (bayley scales of infant development-iii).


Eligibility criteria:
inclusion criteria: * chd warranting a first percutaneous or surgical intervention in the first 6 months, including but not limited to transposition of the great arteries (tga), univentricular heart (uvh), tetralogy of fallot (tof), coarctation of the aorta (coa), total abnormal pulmonary venous drainage (tapvu), common arterial trunc (ta), large patent ductus arteriosus (pda) or vsd and avsd for which treatment is necessary within the first 6 months of life. * treatment provided at the university hospitals leuven. exclusion criteria: * syndromes or proven genetic conditions which are associated with neurological impairment * chd warranting treatment after 6 months of life * suspected or proven metabolic diseases * no parental/guardian consent

Keywords: congenital heart disease neurodevelopment neuromonitoring biomarkers eeg nirs
zinc sulfate for human papillomavirus (hpv)

Conditions: Human Papilloma Virus

Summary: the human papillomavirus (hpv) is well established as the primary causative agent in both warts and cervical cancer. although cervical high risk hpv (hrhpv) infections have a high rate of spontaneous resolution this takes time and the infection can cause cervical cells to progress to precancerous and cancerous lesions. zinc has been shown to play a central role in immunity. this study is to determine if oral zinc sulfate can improve clearance rates of high risk hpv versus placebo.

upon enrollment eligible participants will be randomized and given a three-month supply of zinc sulfate or placebo to be taken as directed. they will have zinc serum lab testing at enrollment and upon study completion. patients will also be asked to complete short questionnaires and to make study staff aware of any side effects they should experience.

Eligibility criteria:
inclusion criteria: * abnormal cytology of atypical squamous cells of undetermined significance (ascus) on pap smear or * low-grade squamous intra epithelial lesions (lsil) on pap smear or * positive hrhpv on routine screening (positive hpv will be assumed to be high grade) exclusion criteria: * patients who proceed to excisional procedures (loop electrosurgical excision procedure or cold knife conization) * pregnant patients * breastfeeding patients * immunocompromised patients

Keywords: hpv ascus lsil cervical cancer
targeted intraoperative radiotherapy with intrabeam as a boost for breast cancer - a quality control registry

Conditions: Breast Cancer

Summary: quality control registry for iort used as an anticipiated boost with 20 gy at the applicator surface followed by ebrt

quality control registry of a standard treatment with intraoperative radiotherapy during breast conserving surgery with 20 gy at the applicator surface as an advanced boost followed by a shortened external beam radiotherapy. this is a prospective phase iv study to evaluate real life data of iort boost. study runs in germany with 13 active centers recruiting. due to the nature of the study (registry) there is no need for randomization. inclusion of n = \>1000 patients is planned.

Eligibility criteria:
inclusion criteria: * tumor diameter \< 3,5 cm * informed consent exclusion criteria: * no informed consent * tumor size \> 3,5 cm * no indication for a boost

Keywords: iort boost breast cancer local recurrence toxicity lent soma targit quality control registry
clinical trial assessing two protocols to withdraw non-invasive ventilation in hypercapnic respiratory failure

Conditions: Hypercapnic Respiratory Failure

Summary: the purpose of the study is to determine the optimal method to withdraw non-invasive ventilation after an episode of hypercapnic respiratory failure.


Eligibility criteria:
inclusion criteria: * acute hypercapnic respiratory failure. * use of niv to treat respiratory failure. * persistence of hypercapnia after discontinuation of niv exclusion criteria: * home niv * facial or cranial trauma or surgery, * recent gastric or esophageal surgery, * active upper gastrointestinal bleeding, * excessive amount of respiratory secretions, * tracheostomy * lack of cooperation
magnetic resonance (mr) spectroscopy of breast cancer tissue

Conditions: Breast Neoplasms

Summary: breast cancer tissue is collected from women undergoing scheduled surgery for breast cancer. the tissue specimen are analyzed by mr spectroscopy. after mr, the intact tissue specimen can be analyzed by other methods, such as histopathology. the mr spectral profiles are compared to clinical findings such as the patients diagnosis, lymph node status and tumor size.


Eligibility criteria:
inclusion criteria: * palpable breast cancer lesion

Keywords: magnetic resonance spectroscopy
impact of the postponement of surgery on postoperative morbidity after sars-cov-2 infection

Conditions: SARS CoV 2 Infection

Summary: the deployment of vaccination against sars-cov-2 from 2021 led to a modification in june 2021of previous recommendations concerning the postponing scheduled surgery suggesting local adaptations of this delay if epidemic developments appear. today, the evolutions of the pandemic make these recommendations obsolete and impose the updating of the data produced during the first epidemic wave of 2020. among these evolutions, the two most important are the existence of a large vaccination coverage on the one hand and the emergence of variants of lesser severity on the other hand

previous studies performed during the first covid-19 epidemic wave in the first half of 2020 led to the recommendation, after taking into account the individual risk-benefit balance, of postponing scheduled surgery for ideally at least 6 completed weeks in a patient with a positive preoperative sars-cov-2 pcr. the deployment of vaccination against sars-cov-2 from 2021 led to a modification of these recommendations in june 2021 suggesting local adaptations of this delay if epidemic developments appear. today, the evolutions of the pandemic make these recommendations obsolete and impose the updating of the data produced during the first epidemic wave of 2020. among these evolutions, the two most important are the existence of a large vaccination coverage on the one hand and the emergence of variants of lesser severity on the other hand

Eligibility criteria:
inclusion criteria: * adult patients, * surgery performed in the operating room under general or locoregional anesthesia. * result of the preoperative sars-cov-2 diagnostic test available on the day of the procedure or within 48 hours of the surgery. * emergency or scheduled surgery * all surgical indications will be eligible with the exception of certain surgeries exclusion criteria: * minor patient * pregnant patient * surgery or an intervention performed outside the operating room * patient operated under sedation alone, * patient under guardianship or curatorship * patient without social protection * patient previously included in this study * patient without preoperative covid-19 status on day of surgery and not diagnosable within 48 postoperative hours * patient whose immediate postoperative follow-up is planned in a structure other than those where the inclusion was made
propranolol in primary progressive aphasia

Conditions: Aphasia, Primary Progressive

Summary: the purpose of this study is to find out how the language of people with primary progressive aphasia is affected by propranolol. propranolol is not fda approved for the treatment of primary progressive aphasia. propranolol is fda approved for the treatment of heart conditions such as blood pressure. this research is being done because there are currently no drug treatment options for language impairments and anxiety often experienced by people with primary progressive aphasia.


Eligibility criteria:
inclusion criteria: * 1. age: 50 and older * 2. primary progressive aphasia diagnosis * 3. native english speaker exclusion criteria: * 1. unable to provide consent * 2. taking alpha 2 agonists (clonidine and guanfacine) * 3. other major psychological or neurological diagnosis * 4. major head trauma that contributed to their condition * 5. allergic reaction to adhesives * 6. uncorrected vision/hearing impairments * 7. diabetes * 8. reactive airway disease * 9. untreated hypothyroidism * 10. bradyarrhythmia * 11. unexplained syncope * 12. pregnancy (assessed verbally on the days of mr imaging) * 13. drugs that interact with propranolol, such as alpha 2 agonists * 14. claustrophobia, inner ear implants, aneurysm or other surgical clips, metal foreign bodies in eye, pacemaker or other contraindication to mr scanning. subjects with any implanted device that cannot be verified as mri compliant will be excluded.
high volume plasma exchange in children with acute liver failure and acute on chronic liver failure

Conditions: Acute Liver Failure

Summary: all the children with acute liver failure who are candidates for transplant but have constraints for transplant will be randomized either to receive standard medical therapy or high volume plasma exchange along with standard medical therapy with the aim to assess the effect of high volume plasma exchange on transplant free survival.


Eligibility criteria:
inclusion criteria: - children ≥ 10kg with alf with inr ≥ 4 or inr ≥ 3 with hepatic encephalopathy. exclusion criteria: 1. evidence of active infection (age specific neutrophilic leucocytosis (anc) and procalcitonin ≥ 2 and/or focus of active infection 2. refusal of consent or assent (annexure 3) 3. liver resections with liver failure 4. patients with clinical suspicion of irreversible brain injury 5. patients with acute kidney injury