Kornimate/medical-research-clean huggingface dataset:
clinical trial comparing three anterior cruciate ligament reconstructive procedures

Conditions: Knee Injuries

Summary: the objective of this prospective study is to assess the clinical, functional and radiological outcomes of three different acl reconstruction procedures: bone patella bone graft, single bundle hamstring graft and anatomical double bundle graft in terms of pain, swelling, mobility, quadriceps girth size, stability, proprioception, bone mineral density and functional status.

anterior cruciate ligament (acl) reconstruction surgery is one of the common procedures performed by orthopedic surgeons with approximately 100,000 cases performed per year in the united states. a large amount of sports injuries were related to acl problem. as such, acl injuries and treatment is still widely under intensive study. traditionally, acl surgery has been focused on using bone patella bone graft and single bundle hamstring graft. problems of knee pain, unstable fixation, rotational instability and degenerative changes were reported. recently, the use of double bundle hamstring graft to reconstruct the acl according its anatomy aiming to improve the rotational stability was proposed. however, results about the clinical, functional and radiological outcomes are limited. the objective of this prospective pilot study is to assess the clinical, functional and radiological outcomes of three different acl reconstruction procedures: bone patella bone graft, single bundle hamstring graft and anatomical double bundle graft in terms of pain, swelling, mobility, quadriceps girth size, stability, proprioception, skin sensation, bone mineral density and functional status. subjects to be operated for acl reconstruction and meeting the inclusion and exclusion criteria will be recruited. subjects will be randomly assigned to the three surgical groups by block randomization. demographic information, parameters in recovery domain, functional domain and stability domain, isokinetic test, motion analysis domain, proprioception and radiographical measurements will be made at baseline and at day 1, week 2, week 4, week 8, month 3, month 5, 1 year and 2 years post-surgery. the effect of different surgical techniques and time on the different outcomes will be analysed by 2-way anova.

Eligibility criteria:
inclusion criteria: * men above age 18-40 years old * first acl reconstruction surgery * single leg involvement exclusion criteria: * acl injury less than 6 weeks as deleterious effect of the injury may affect the extension range * injury on duty (iod) cases * other associated injuries (fractures, other ligaments involvement, neurovascular bundles injury),chondral lesion with co-commitment intervention * concomitant meniscus repair in same operation, or within 3 months before the operation * significant oa changes * known chronic disease or receiving long term medications affecting bone metabolism, including anabolic steroids, medication for thyroid hormone therapy or osteoporosis * neurological deficit

Keywords: anterior cruciate ligament rupture anterior cruciate ligament(a02.513.514.100)
a single arm trial of oxaliplatin and 5fu with concurrent radiation in patients with metastatic rectal cancer

Conditions: Rectal Cancer

Summary: this trial is a single-arm study for patients presenting with both local and metastatic adenocarcinoma of rectum. the aims of the trial are (1) to determine the tolerability rate, and (2) to determine toxicity rates, pelvic and distant response rates in patients with locally advanced rectal cancer in the presence of distant metastasis who are treated with an interdigitating chemotherapy (oxaliplatin/5-fluorouracil \[5fu\]) and radiotherapy regimen.

* week 1: oxaliplatin 100 mg/m2 day 1 (over 2 hours), leucovorin 200mg/m2 day 1 concurrent with oxaliplatin over 2 hrs, then 5-fu 400mg/m2 bolus day 1, then 5-fu continuous infusion 2.4 g/m2 over 46 hours from day 1. * weeks 3 to 5: radiotherapy 25.2 gy in 14 fractions over 3 weeks with 85 mg/m2 oxaliplatin on the first day and continuous infusion 5-fu 200 mg/m2/day on the days of radiotherapy, * week 6: as per week 1, * weeks 8-10: as per weeks 3-5 * weeks 11: as per week 1.

Eligibility criteria:
inclusion criteria: 1. patients with previously untreated and pathologically proven adenocarcinoma of the rectum with distant metastasis who would benefit from combined local therapy and systemic chemotherapy. 2. lower border of tumour must be within 15cm of anal verge. 3. age \>= 18 years. 4. ecog performance status 0-2 5. absolute neutrophil count \> 1.5x10\^9/l, haemoglobin \> 100 g/l, and platelets \> 100x10\^9/l. 6. renal: creatinine clearance \>= 55 ml/min (using radioisotope renal scan or derived from serum creatinine using the cockcroft-gault formula). 7. bilirubin \<= 2.0 x upper limit of normal. 8. alt \<= 5 x upper limit of normal 9. life expectancy in excess of 3 months. 10. no symptomatic peripheral neuropathy \> grade 2. 11. males or non-pregnant, non-lactating females. female patients of child-bearing potential, not surgically sterilized, must use an adequate form of contraception (oral contraceptive pill or barrier method). 12. signed informed consent exclusion criteria: 1. prior pelvic radiotherapy 2. febrile intercurrent illness or infection. 3. history of myocardial infarction within the previous six months or unstable cardiac disease or any other medical condition likely to compromise the safe delivery of chemotherapy or radiotherapy. 4. concurrent treatment with other anti-cancer therapy. 5. significant medical conditions which in the opinion of the investigator would compromise the planned delivery of the chemotherapy and radiotherapy or which may be potentially exacerbated by these modalities. 6. locally recurrent rectal cancer
intravenous amino acid therapy for kidney protection in cardiac surgery.

Conditions: Cardiac Surgery

Summary: to date, no pharmacological agents are proven efficacious in treating perioperative aki. there is a strong biological rationale for the administration of amino acid in the management of patients at risk of aki with increases in renal blood flow and gfr of 25 to 60% for several hours after the administration of amino acids (woods ll 1993) mediated by a afferent arteriolar dilation.(meyer tw 1983) moreover, animal models have demonstrated that an increase in renal blood flow in response to a short-term amino acid infusion can protect the kidney from acute ischemic insults. finally, these nephro-protective effects are preserved in critical illness. cardiac surgery appears to be the best setting to test the likely beneficial renal effects of amino acid because of pathophysiological principles and the ability to intervene before the injury has begun. although the etiology of aki in cardiac surgery is multifactorial, renal hypoperfusion is believed to play a major role in this development by decreasing renal perfusion through a reduction in renal blood flow and through the activation of the sympathetic nervous system and the renin-angiotensin system with afferent arteriolar vasoconstriction. in this setting, a global increase in renal blood flow by means of amino acid therapy appears a logical and promising intervention. the primary aim of the study is to determine whether providing continuous infusion of a balanced mixture of amino acids, compared to placebo (balanced crystalloid solution), reduces the incidence of acute kidney injury (aki) in patients scheduled for cardiac surgery defined as kdigo stage 1 or greater during hospital stay.


Eligibility criteria:
inclusion criteria: * age \> 18 years * scheduled cardiac surgery * expected to stay in icu at least 1 night after surgery * signed informed consent exclusion criteria: * patient currently enrolled into another randomized clinical trial * patient currently receiving or scheduled for intermittent or continuous renal replacement therapy * patients with ckd of equal or more than ckd stage iv (gfr\<30 ml/min/1.73 m2) * patient with a kidney transplant * patient is not expected to survive icu or hospital discharge * patient previously been enrolled and randomized into this study * patient has severe liver disease (child-pugh score \>7 points) * patient has a hypersensitivity (known allergy) to one or more of the included amino acids * patient has a congenital alteration of amino acid metabolism * pregnant or currently breastfeeding patients * patients with any of the contraindications reported in the summary product characteristics.

Keywords: kidney protection acute kidney injury cardiac surgery amino acids mortality icu
analyses of human samples collected in clinical trials

Conditions: Leukemia, Myeloid; Neoplasm Metastasis; Leukemia, Lymphoid; Prostate Cancer

Summary: cancer patients in clinical trials donate various human samples (e.g., serum, plasma, blood, urine, feces, bile, saliva) for research purposes. the purpose of this study is to conduct further analyses on these existing samples from clinical trials that are being performed outside of, but in collaboration with, the national cancer institute.

various human samples (e.g., serum, plasma, whole blood, erythrocytes, urine, feces, bile, and/or saliva) will be collected from cancer patients enrolled on approved clinical trials, in accordance with the local protocol. these trials are being conducted at outside institutions, in collaboration with the national cancer institute (nci) and the samples will be sent to the nci for pharmacological analysis, involving determination of parent drug and/or metabolite concentrations and subsequent pharmacokinetics and statistical data analysis. this study aims to further characterize the clinical pharmacokinetic behavior of select cancer therapeutics. future collaborators will be added via the protocol amendment procedure.

Eligibility criteria:
* inclusion criteria: any patients entered on approved trials of cancer therapeutics or agents that are commonly administered to patients with cancer at institutions outside of the intramural nci are eligible for inclusion, provided that they have consented to pharmacological analysis in the original consent form. exclusion criteria: none anticipated at this time.

Keywords: pharmacokinetics quantify hplc lc/ms pharmacodynamics
molecular stethoscope

Conditions: Colonic Neoplasms

Summary: the study aims to provide a more complete characterization and understanding of the genetic causes of and tumor dna detection potential in colorectal cancer. ultimately findings of this study will be used to develop early detection tests for colorectal cancer that are minimally invasive (based on a blood test). it is hoped that reliable, minimally invasive, early detection methods will lead to improved screening rates, increased screening safety, longer colorectal cancer survival, and overall cost savings. in order to assess the test's ability to detect tumor dna, 25 participants with known colorectal cancer who will be undergoing surgical resection of the colon as part of their clinical care will be recruited. the investigators will collect blood from participants prior to surgery, tumor and normal tissue removed during surgery, a series of blood samples after surgery for up to one year and relevant medical records. dna variants identified in blood will be compared against tissue samples. serial samples will be analyzed to assess the variance in amount of circulating tumor dna across time with standard treatment.


Eligibility criteria:
inclusion criteria: * colorectal cancer sent for surgical colonic resection (all stages) or * high risk adenoma sent for surgical colonic resection exclusion criteria: * chemotherapy before surgical treatment * invasive procedure resulting in damage to tissue (e.g., surgery, biopsy, thermal ablation) in the 7 days prior to baseline (pre-surgical) blood collection * radiation therapy before surgical treatment * bone marrow transplant
assessment of tissue oxygenation using multispectral imaging

Conditions: Diabetes Mellitus

Summary: in canada, the age-standardized prevalence of diabetes is on the rise (increasing from 3.3% in 1998/99 to 5.6% in 2008/2009 public health agency of canada (july 2011)) and is almost 1 in 10 globally. one of the most devastating complications of diabetes is the loss of a limb, (also known as lower extremity amputation, or lea) due to complications resulting from a diabetic foot ulcer (dfu). diabetics have a lifetime risk of 15-25% of developing a dfu1, which can lead to significant decreases in the quality of life, limitations in mobility, function and independence, and increased chance of depression and anxiety. in addition, diabetics post-lea have high rates of mortality, with 30% dying in the first year post lea and 70% at 5 years (more than the lifetime risk of dying from cancers). what differentiates a dfu that heals and one that progresses to lea is often the vascularity of the limb; the diabetic lower extremity often becomes ischemic due to the vascular sequelae that are a common complication of diabetes, which hampers wound closure and immune clearance of wound-associated infections. understanding limb oxygenation can direct treatment of a dfu, which may require limb revascularization to heal.

the multispectral mobile tissue assessment (mimosa) imager acquires digital images to calculate anatomical details of chronic wounds (e.g. diameter, surface area, and perimeter). the device can be worn from a lanyard, and clips onto a smartphone, using natural ambient lighting to capture images of a wound. the mimosa also uses up to 6 near-infrared leds to illuminate tissue with different wavelengths of light to assess tissue oxygenation. the food and drug administration (fda) has previously approved a near-infrared device called the kent camera for the assessment of tissue oxygenation. the goal of this proposal is to assess tissue oxygenation in a group of healthy volunteers with both the mimosa near-infrared imaging device and the kent camera. the investigators hope to show that the mimosa imager is substantially equivalent to the kent camera, and as such, the investigators are modeling the investigator's experiments on data previously published by the makers of the kent camera. the mimosa imager is a contact-less device, and differs from the kent camera only in that it is smaller and more portable.

Eligibility criteria:
inclusion criteria: age (years) 26 ± 3 (22-33) gender (male/female) 6/6 height (m) 1.70 ± 0.10 (1.56-1.83) weight (kg) 65 ± 11 (49-79) body mass index (kg/m2) 22 ± 2 (20-26) systolic pressure (mmhg) 115 ± 15 (83-138) diastolic pressure (mmhg) 73 ± 10 (59-91) exclusion criteria: 1. health concerns including diabetes 2. patients who are unable to understand the aims of the study and not give informed consent

Keywords: tissue oxygenation near-infrared diabetic foot ulcer (dfu) diabetes vascularity
carbon dioxide during screening unsedated colonoscopy

Conditions: Polyps

Summary: colonoscopy is currently most effective procedure used for detecting colon cancer especially in the early stages. screening colonoscopies are performed in the symptom-free patients at risk of familial colon cancer. during colonoscopy air commonly used to insufflate the bowel may be retained after the procedure causing pain and discomfort to the patients. one of the methods used to reduce pain and discomfort is insufflation of carbon dioxide (co2) instead of air during colonoscopy. aim of the study is evaluation of the use of carbon dioxide insufflation during colonoscopy.

the study was conducted in 200 consecutive patients undergoing screening colonoscopies for the detection of early colon cancer. the examinations were performed with olympus 165 colonoscopes by seven experienced endoscopists, each of whom performed alone about over 2000 colonoscopies. the patients were randomly assigned to group i and ii with either air or carbon dioxide insufflation. both study groups were matched by sex, age, duration of the procedure, and bmi. the authors compared for the duration of the procedure, coecal intubation time, complication rate, pulse rates immediately after the procedure, 15 minutes after, and subjective pain evaluation on a visual analogue scale.

Eligibility criteria:
inclusion criteria: * age 50 yo and more * no previous large bowel operations * no previous colonoscopy * informed consent exclusion criteria: * previous colonoscopy * previous large bowel operations/ polypectomies

Keywords: screening colonoscopy carbon dioxide air pain score complications
working memory training for children with cerebral palsy

Conditions: Cerebral Palsy

Summary: cerebral palsy (cp) is the most common motor disability in childhood (2-3 per 1000 live born), and is frequently accompanied by cognitive impairments and behavioural problems. the present study is a controlled clinical trial, a multicenter-study involving three health regions, as well as the norwegian university of science and technology (ntnu). its primary research goal will be to evaluate the effects of computer-based cognitive training in children with cp. in addition, this study will be the first to conduct a comprehensive neuropsychological examination to improve our understanding of cognitive impairments as well as cognitive resources in cp children in norway to aid in intervention planning.


Eligibility criteria:
inclusion criteria: * cerebral palsy * school age (7-15 years of age) exclusion criteria: * not able to use computer, blind, deaf

Keywords: cerebral palsy working memory cognitive training
study of risk factors for intraductal papillary mucinous neoplasms degeneration at the nancy chru (ipmn)

Conditions: Study of Risk Factors for IPMNs Degeneration at the Nancy CHRU

Summary: cystic lesions of the pancreas are frequent with a risk of degeneration into adenocarcinoma with pejorative prognosis. ipmns require characterization to clarify their potential for degeneration. clinical and morphological risk factors for degeneration determine the monitoring rate and the indication for pancreatic surgery. pancreatic surgery remains invasive with high morbidity and mortality rates.

this is a monoservice and monocentric retrospective study at the nancy chru. we will study the risk factors for ipmns degeneration in order to determine the most sensitive and specific. to do this, we will use high-grade dysplasia or invasive cancer on the histological analysis of surgical specimens as the primary endpoint. the study population will be patients with branch duct, main duct or mixed ipmns operated at the nancy chru between september 2009 and october 2021.

Eligibility criteria:
inclusion criteria: * patients with a branch duct, main duct or mixed ipmns operated at the nancy chru between september 2009 and october 2021, adults and without legal protection measures exclusion criteria: * ipmns not operated * pancreatic cancer without ipmns * patients whose state of health contraindicates pancreatic surgery * non-adult patient * patients under legal protection

Keywords: ipmns intraductal papillary mucinous neoplasms
developing a tool to support shared decision making post-concussion between adolescents, parents and clinicians

Conditions: Concussion, Brain

Summary: investigators will conduct a pilot efficacy test of a decision aid about contact sport participation post-concussion.

the clinical trial portion of this study will enroll 40 adolescents and their parent/caregiver who are seen in the sports medicine clinic with a diagnosis of concussion. 20 will receive usual care, and 20 will receive a decision aid to facilitate the decision making process about sport participation post-concussion. adolescents and their parent/caregiver will complete separate surveys at a minimum of three timepoints: before their initial clinic visit, after each clinic visit (up until a decision regarding sports participation post-concussion is made), and three months after their first clinic visit. the study team will also conduct surveys with clinicians about their experiences with implementation.

Eligibility criteria:
participants in the clinical trial component of this study will be adolescents, parents, and healthcare providers: adolescent inclusion criteria: * age 11-17 * sustained at least 1 concussion and is scheduled for a concussion injury visit parent inclusion criteria: * age 18 or older * parent of a child between the age of 11 and 17 (inclusive) who has sustained at least 1 concussion and is scheduled for a concussion injury visit healthcare provider inclusion criteria: * age 18 or older * seattle children's affiliated healthcare provider who provides patient care to youth with concussion
efficacy of hiatal closure for gerd

Conditions: Gastro Esophageal Reflux

Summary: the purpose of this protocol is to study the efficacy of hiatal closure for early gerd disease. the study team hypothesizes that hiatal closure for early gerd disease is an efficacious treatment of gerd.

gastro-esophageal reflux disease (gerd) affects 60 million americans involving an estimated 20 million americans dependent on long term medication to control symptoms and progression of the disease. although surgical hiatal hernia repair and creation of an anti-reflux valve can correct the underlying cause of gerd by repairing the anatomic defect and reestablishing the competency of the lower esophageal sphincter (les), only 24,000 patients annually undergo surgery for gerd. however, with the advent of minimally invasive laparoscopic techniques to treat gerd, more patients at early phases of the disorder are being surgically treated. the traditional approach to surgical treatment of gerd has been hiatal hernia repair with nissen fundoplication. however, fundoplication itself may be unnecessary for recovery of the lower esophageal sphincter. several groups have demonstrated that partial or even minimal wrapping of the esophagus achieves equal control of gerd to complete wrapping. despite extensive geometric and physics-based explanations for this observational enigma, the science underlying these highly reproducible observations across surgeons and continents remains poorly understood. furthermore, outcomes following hiatal hernia repair alone for the treatment of gerd have not been studied since before the advances in laparoscopic technique. because of the high-volume gastrointestinal surgery center, the study team has the opportunity to rigorously study patient-centered outcomes and the disease processes as they are treated with this surgery. these outcomes after hiatal closure alone have not been published with the use of minimally invasive techniques where rigorous repairs can be achieved and thus, the study team is seeking this opportunity to demonstrate the efficacy of hiatal closure alone and recovery of the lower esophageal sphincter in those patients with symptomatic gerd and small hiatal defects. publishing outcomes of this technique would represent a great leap forward in enhancing the knowledge base upon which to define the principles and techniques for the surgical treatment of gerd.

Eligibility criteria:
inclusion criteria: * age 18 - 50 years * able to provide informed consent * bmi \<30 * hiatal defect \<4cm on esophagram * ph testing requirement: ph \ 5.5% * surgical candidate for hiatal closure only exclusion criteria: * vulnerable subjects (children, prisoners, pregnant women) will be excluded.