Kornimate/medical-research-clean huggingface dataset:
grafixprime® for the treatment of chronic diabetic foot ulcers

Conditions: Foot Ulcer, Diabetic

Summary: the objective of the study is to compare the efficacy of weekly grafixprime® administration to an active comparator in patients with chronic dfus in a randomized, single-blind study.


Eligibility criteria:
inclusion criteria: * type 1 or type 2 diabetes * chronic ulcer (present for ≥4 weeks, but not more than 52 weeks) * index ulcer located below the malleoli on the plantar or dorsal surface of the foot * index ulcer extends into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone or joint capsule * adequate circulation to the foot (documented by abi or tbi) exclusion criteria: * gangrene present on affected foot * index ulcer is over a charcot deformity * patient is receiving dialysis * patient has 2 or more previous amputations * patient has hba1c \>12% or random blood sugar \>450 mg/dl * chronic oral steroid use * use of iv corticosteroid, immunosuppressive, or cytotoxic agents * iv antibiotics * another ulcer within 5cm of the index ulcer * cellulitis, evidence of infection, or osteomyelitis

Keywords: grafix
health status prior and post infection with influenza or covid 19: a population based retrospective analysis of 2016-2021

Conditions: Covid 19; Influenza

Summary: the overall project aim is to study outcomes after covid-19 and influenza hospitalisation from 2016 - 2021 by retrieving data from the main social security carriers in austria for the years 2010-2018


Eligibility criteria:
inclusion criteria: * patients with sars * patients with covid-19 * patients after covid-19 * patients with influenza exclusion criteria: * none
prospective registry of anterior cruciate ligament reconstructions

Conditions: Anterior Cruciate Ligament Tear; Meniscal Tear; Cartilage Injury; Bone Bruising

Summary: the purpose of the study is to investigate factors that are associated with outcomes of injury to the anterior cruciate ligament (acl) in the knee among patients who are undergoing surgical reconstruction. this study is a registry of all patients having knee surgery at our institution performed by 4 fellowship-trained orthopaedic surgeons. the surgeon documents patient information on standard data forms including risk factors and surgical findings.


Eligibility criteria:
inclusion criteria: * patients undergoing acl surgery exclusion criteria: * previous surgery on the affected knee * posterior cruciate ligament injuries * grade 2 lateral collateral ligament or medial collateral ligament injuries
the effects of gastric tube on the quality of life and nutritional status after ivor-lewis esophagectomy

Conditions: Oesophageal Cancer

Summary: this study is to investigate the effects of narrowed gastric tube on postoperative nutritional status and the quality of life in esophageal cancer patients treated with ivor-lewis esopagectomy in a 12-month follow-up period.


Eligibility criteria:
inclusion criteria: * esophageal cancer (squamous and adenocarcinoma subtypes) * eligble for ivor-lowis esophagectomy * expected survival time longer than 12 months exclusion criteria: * palliative resection(non-r0) * anastomosis leak * jejunum or colon transversum interponate
the effect of diet counseling for low calorie-high protein on the body composition, inflammation marker, and oxidative stress marker in obese people with weight cycling

Conditions: Low-Calorie Diet; Diet, High-Protein; Obesity; Pituitary; Weight Cycling

Summary: the world prevalence of obesity in adult population in 2014 was nearly 13% while in indonesia, it has reached 32.9% in the same year. obesity is an established risk factors for cardiovascular diseases. a large proportion of people who had succeeded to reduce body weight failed to maintain it (weight cycling). studies were inconclusive about the best composition in the diet for such people to have a better life quality and reduce risk factors from non-communicable disease. the purpose of this research was to evaluate the body composition changes, inflammation marker and oxidative stress marker changes resulted from low calorie high protein and standard protein diet programme in obese people with history of weight cycling. this is an open-randomized clinical trial of weight loss program as a part of a larger study researching the effect of low calorie high protein diet to body composition, oxidative stress, inflammation marker and metabolic syndrome in obese with weight cycling. subjects were assigned to low calorie diet and were randomly distributed into two intervention groups, namely high protein group (22-30 % of total calories intake) and standard protein group (12-20%). anthropometry, body composition data, and blood sample (for inflammation marker (hscrp) and oxidative stress (malondialdehyde and glutathione)) were taken at baseline and at the end of the study. subjects were followed up to 8 weeks with daily reminder and weekly counselling


Eligibility criteria:
inclusion criteria: * body mass index ranging from 25 - 35 kg/m2 * history of weight loss ≥2 kg and regaining weight into or exceeding its initial body weight at least twice in last five years exclusion criteria: * diabetes mellitus * history of gastrointestinal tract resection * hormonal disorders * using hormonal contraception * menopause, * kidney function disruption

Keywords: low-calorie diet diet, high-protein obesity weight cycling body composition high-sensitivity c-reactive protein malondialdehyde glutathione
screw versus tightrope syndesmotic injury fixation in weber c ankle fractures

Conditions: Trauma

Summary: the aim of our study is to compare two different syndesmosis transfixation methods in ao/ota weber c ankle fractures. our hypothesis is that 50% of screw fixed fibulas but only 5% of suture-button fixed fibulas are in malposition. all skeletally mature patients (16 years or older) with ao/ota weber c type fractures operated within a week after trauma are consecutively included into the study. the tibiofibular transfixation is randomly performed either by a 3,5 mm tricortical screw or a suture-button (tightrope). malposition of the tibiofibular joint is assessed in an intraoperative computed tomography. clinical outcome is assessed by using olerud-molander, rand ja 36-item healt survey after 1-year from the injury.

the aim of our study is to compare two different syndesmosis transfixation methods in ao/ota weber c ankle fractures. screw fixation is widely and mostly used transfixation but suture-button is also shown to be a biomechanically stable and probably more physiologic transfication method. it is shown that even 50 % of the syndesmosis srews and thus fibulas are in malposition. with more physiologic suture-button transfixation this malposition is thought to be less commmon. there is no studies comparing screw and suture-button syndesmosis transfixation methods in ao/ota weber c ankle fracture patients. our hypothesis is that 50% of screw fixed fibulas but only 5% of suture-button fixed fibulas are in malposition assessed in the intraoperative computed tomography. malposition is assessed to present if difference between fractured and non-fractured side is at least 2 mm in the tibiofibular joint. thus, the sample size is assessed to be 19 patients per group (alpha=0.05, beta=0.2, 20% drop out). all skeletally mature patients (16 years or older) with ao/ota weber c type fractures operated within a week after trauma are included into the study. exclusion criteria are previous ankle fracture, concomitant tibial fracture, diabetes with peripheral neuropathy, pathological fracture or inadequate co-operation. after bony fixation the tibiofibular transfixation is randomly performed either by a 3,5 mm tricortical screw or a suture-button (tightrope). an intraoperative computed tomography is imaged from the both ankles of all patients. the operation is continued with six weeks casting without weight-bearing. clinical outcome was assessed using the olerud-molander scoring system, rand 36-item health survey, and visual analogue scale (vas) to measure pain and function after a minimum 1-year of follow-up.

Eligibility criteria:
inclusion criteria: * ao/ota weber c ankle fracture, operation within 7 days from the injury exclusion criteria: * bilateral or previous ankle fracture, tibial shaft fracture, diabetes wiht polyneuropathy, inadequate co-operation

Keywords: ankle; fracture; syndesmosis;
does midazolam cause effective anterograde amnesia in orthopedic surgeries?

Conditions: Anesthesia; Orthopedic Surgery

Summary: spinal anesthesia is one of the commonest choices of anesthesia for infraumbilical surgeries.the use of sedation has markedly increased patients' comfort and acceptance towards spinal anesthesia. the aim of this study is to investigate visual, recall, auditory recall, and sedation scores among patients receiving midazolam for sedation during spinal anesthesia in patients undergoing orthopedic surgeries.

spinal anesthesia is one of the commonest choices of anesthesia for infraumbilical surgeries.the use of sedation has markedly increased patients' comfort and acceptance towards spinal anesthesia. the main goals of sedation for surgeries under spinal anesthesia are patient comfort, preservation of protective airway reflexes, and the help in the maintenance of hemodynamic stability during the surgical procedure. the aim of this study is to investigate visual, recall, auditory recall, and sedation scores among patients receiving midazolam for sedation during spinal anesthesia in patients undergoing orthopedic surgeries.

Eligibility criteria:
inclusion criteria: * patients undergoing total knee or total hip replacement. * asa i, ii, or iii. * patients undergoing spinal anesthesia. exclusion criteria: * patient refusal. * \<24 hours sedative administration. * patient with hearing impairment. * neurological or memory disorder. * abnormal kidney function tests. * any contraindication for spinal anesthesia.

Keywords: midazolam orthopedic surgery total knee replacement total hip replacement
breathe free: a pilot feasibility trial

Conditions: Smoking Cessation; Tobacco Dependence; E-Cig Use; Nicotine Dependence, Other Tobacco Product

Summary: the overall purpose of this pilot study is to assess the feasibility and acceptability of an in-person faith-based intervention to help people stop tobacco use. the study will address use of different types of tobacco products, such as smoking combustible cigarettes, cigarillos and little filtered cigars, and using/vaping electronic nicotine delivery systems (vape pens, e-cigs, and juul). the intervention consists of 12 weekly meetings in which participants will go through breathe free, a study guide curriculum designed to teach character strengths and promote resilience. this pilot research will provide information and practical lessons on how to improve breathe free implementation, increase engagement of the local people, and maximize their benefit. the main questions it aims to answer are: * do participants find breathe free curriculum acceptable, engaging and helpful to stop tobacco use? * do participants who complete breathe free curriculum smoke fewer cigarettes per day? researchers will assign participants to either breathe free curriculum or usual care. participants will: * be taught breathe free curriculum or be given information and referral to tobacco quit line * breathe free group will attend 12 group meetings held on the university campus * all participants will answer interview questions related to tobacco use, character strengths and resilience * expired carbon monoxide (co) will be assessed in all participants.


Eligibility criteria:
inclusion criteria: * daily use of one or more tobacco products * valid home address in augusta or the csra * functioning telephone number * speak, read, write in english exclusion criteria: * current use of tobacco cessation medications * enrolled in tobacco treatment program
point of care testing of cholinesterase activity during burn- and polytrauma

Conditions: Trauma; Burns

Summary: goal of this study is to measure serum cholinesterase activity in patients with traumatic and/or burns injury admitted to the emergency room by using point-of- care-test system (poct). serum cholinesterase activity, measured using poct system, might play an important role in the early diagnosis and prediction of patient outcome in trauma-induced systemic inflammation.


Eligibility criteria:
inclusion criteria: * signed written consent * 18 years and older * severe trauma (iss \> 15) * burns injury (2. degree more than 15% body surface or 3 degree more than 10% body surface) * sirs exclusion criteria: * not fulfilling the inclusion criteria * failure to adhere

Keywords: serum cholinesterase plasma cholinesterase pseudocholinesterase systemic inflammation sirs polytrauma
study of rp-6306 with folfiri in advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: the primary purpose of this study is to assess the safety and tolerability of rp-6306 with folfiri in patients with eligible advanced solid tumors, determine the maximum tolerated dose (mtd), identify a recommended phase 2 dose (rp2d) and preferred schedule, and assess preliminary anti-tumor activity.

to assess the safety and tolerability of rp-6306 in combination with folfiri in patients with eligible, advanced solid tumors. incidence and severity of treatment-emergent adverse events (teaes), laboratory assessments, vital signs, electrocardiograms (ecgs), and use of concomitant medications.

Eligibility criteria:
inclusion criteria: * male or female and ≥18 years-of-age at the time of signature of the informed consent * confirmed advanced solid tumors resistant or refractory to standard treatment * eastern cooperative oncology group (ecog) performance status score of 0 or 1. * all patients must have locally advanced or metastatic crc, gi, or esophageal cancer(s) and radiographic evidence of progressing disease. * measurable disease as per recist v1.1 * submission of available tumor tissue or willingness to have a biopsy performed if safe and feasible * acceptable hematologic and organ function at screening * negative pregnancy test for women of childbearing potential at screening and prior to first study drug. exclusion criteria: * inability to swallow and retain oral medications. * chemotherapy or small molecule antineoplastic agent given within 21 days or \<5 half- lives, whichever is shorter, prior to first dose of study treatment. * history or current condition, therapy, or laboratory abnormality that might confound the study results, or interfere with the patient's participation for the full duration of the study treatment. * patients who are pregnant or breastfeeding * life-threatening illness, medical condition, active uncontrolled infection, or organ system dysfunction or other reasons which, in the investigator's opinion, could compromise the participating patient's safety. * major surgery within 4 weeks prior to first study treatment dose. * uncontrolled, symptomatic brain metastases. * uncontrolled high blood pressure * active, uncontrolled bacterial, fungal, or viral infection, including hepatitis b virus (hbv), hepatitis c virus (hcv), known human immunodeficiency virus (hiv), or acquired immunodeficiency syndrome (aids) related illness. * moderate or severe hepatic impairment * cardiac diseases currently or within the last 6 months as defined by new york heart association (nyha) ≥class 2 * psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.
effectiveness and cost-effectiveness of the t-control® catheter in patients with acute urine retention

Conditions: Urinary Retention; Catheter-Associated Urinary Tract Infection; Catheter Complications

Summary: the general purpose of this study is to assess the preliminary effectiveness and cost-effectiveness of the t-control® catheter versus the foley type catheter in patients with acute urine retention.

potential participants will be identified by the team of healthcare professionals of the emergency department according to the inclusion and exclusion criteria of the study. if the patient meets the criteria, the emergency department team will be able to refer patients directly to the urology department, where the investigator or research assistant will again check the inclusion and exclusion criteria, will invite the patient or their relative/caregiver (if necessary) to participate in the study and will request their informed consent. the catheter insertion will be carried out by the research staff after the inclusion and randomisation of the participants. after catheter insertion, participants and their family, friends, or other informal caregivers will receive information about wearing an indwelling urinary catheter and specific information to randomly inserted, standard foley, or t-control® catheters. standard catheter care is permitted during the trial both managed by the participants and participants' caregivers. additionally, participants will receive an incident diary in which participants can record any type of incident during the bladder catheterisation period. two weeks after indwelling bladder catheter insertion, participants will be contacted by urology outpatients for a follow-up visit, during which the study catheter will be removed. finally, within a maximum period of two weeks after the follow-up visit, the participants will be invited to participate in an interview to assess the quality of life perceived by the participants during the study

Eligibility criteria:
inclusion criteria: * males with acute urine retention * equal or over 50 years of age * absence of symptoms of infection on the inclusion day * not having been previously catheterized on the day of inclusion * indication of bladder catheterization for 2 weeks * maintained cognitive and physical capacity for self-monitoring the catheter valve * signed consent agreement exclusion criteria: * current or recent urinary tract infection in the last 2 weeks * use of current treatment/antibiotic in the last 2 weeks * immunocompromised patients (diagnosed with advance cancer, acquired immunodeficiency syndrome,...) * catheter insertion requiring more than 1 attempt * overactive bladder * patients with bilateral obstructive uropathy

Keywords: catheterisation t-control urinary catheter foley catheter
doxil and gemcitabine in recurrent ovarian cancer

Conditions: Ovarian Carcinoma

Summary: standard treatment for recurrent ovarian cancer is chemotherapy with one or more drugs. one of these drugs, doxil, can cause skin toxicity at the standard dosages. this study investigates using a lower dose given more frequently in combination with a second drug gemcitabine.

this study will evaluate the toxicities of doxil and gemcitabine given on an every two week basis. our hypothesis is that toxicity will be less than that with standard dosing without any negative effect on survival. patients will also be evaluated with ct scans every 3 months. toxicity will be assessed with every cycle of treatment. treatment will continue until toxicity or signs of progression.

Eligibility criteria:
inclusion criteria: * recurrent platinum resistant ovarian cancer * measurable disease exclusion criteria: * prior treatment with doxil or gemzar * life expectancy \<3months * cardiac ejection fraction \<50%

Keywords: ovarian cancer recurrent progressive
the effect of type 2 diabetes and dietary regulation on vldl1-and vldl2-triglyceride metabolism

Conditions: Type 2 Diabetes; Dyslipidemia

Summary: in this study the investigators wish to compare very low-density lipoprotein (vldl) kinetics in type 2 diabetic males and healthy males postabsorptive and during hyperinsulinemia. the kinetics is obtained using an ex-vivo vldl1- and vldl2-triglyceride labeling technique. the investigators hypothesis is that the investigators will find an increased vldl1 production in type 2 diabetic males, which is not lowered by hyperinsulinemia. also the investigators wish to investigate the influence of diet on vldl1 and vldl2 production in healthy males, where the investigators expect less variance in vldl production when the subject is given an isocaloric diet.

patients with type 2 diabetes are more likely to suffer from dyslipidemia. earlier research has shown that these patients have an increased vldl production and this could be a key factor in dyslipidemia development. especially the production of vldl1 seems to be increased where an inhibitory response to insulin is lacking. further investigation in vldl1 and vldl2 kinetics is required. the investigators wish: 1. to extend the method of ex vivo labeling of vldl-triglyceride, to include separate labeling of vldl1- and vldl2-triglyceride for evaluation of the separate lipoprotein subtype kinetics. 2. to investigate vldl1- and vldl2-triglyceride kinetics in the post absorptive state and under experimental hyperinsulinemia in twelve type 2 diabetic males compared to twelve healthy age, sex, and bmi matched males. 3. to investigate the effect of a three day isocaloric diet compared to a non-restricted diet on the day-to-day variation in vldl1 and vldl2-triglyceride kinetics in healthy men. the investigators here examine six subjects on two different days who ingest a non-restricted diet and compare this group to six subjects examined on two different days, who have prior ingest a three day isocaloric diet.

Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes during at least six month or healthy subjects * male * bmi 25-36 kg/m2 * age 35-65 exclusion criteria: * other diseases (hypertension and hypercholesterolemia tolerated) * insulin treatment * alcohol abuse * smoking * medication affecting lipid metabolism apart from statins and antihypertensive drugs paused 2 weeks prior to the study day. * participation in studies involving radioactive isotopes or larger x-ray investigations within the last six month. * blood donation within three month.

Keywords: type 2 diabetes very-low-density-lipoprotein(vldl) vldl1 vldl2 hyperinsulinemia diet