Kornimate/medical-research-clean huggingface dataset:
effect of fruit and vegetables on insulin resistance

Conditions: Cardiovascular Disease

Summary: current evidence indicates that fruit and vegetable intake and dietary patterns rich in fruit and vegetables may be associated with reduced insulin resistance and may reduce the risk of the metabolic syndrome. if proven, this relationship may partly explain the inverse association between fruit and vegetable intake and cardiovascular disease risk. there are currently no published dietary interventions that have examined in detail the relationship between fruit and vegetable intake and insulin resistance. there is, however, some preliminary evidence from whole diet interventions that a diet rich in fruit and vegetables may have a beneficial effect on insulin resistance. evidence to date indicates that an investigation of the direct association between fruit and vegetable intakes and insulin resistance in a carefully controlled intervention study is warranted. this study will investigate the dose-response effect of fruit and vegetable intake on insulin resistance in people who are overweight and at high-risk of cvd using state-of-the-art techniques.


Eligibility criteria:
inclusion criteria: * bmi between 27-35 * cvd risk \>20% over 10 years (using the joint british society risk assessment tables) * low consumers of fruit and vegetables (\<2 portions per day) exclusion criteria: * diabetes * existing cvd * food intolerance/sensitivity preventing adherence to a high fruit and vegetable diet * subjects taking antioxidant supplements * surgery within the last 3 months * pregnancy/lactation * aspirin * subjects following a weight loss diet

Keywords: fruit vegetables intervention insulin resistance cardiovascular disease risk dose response high risk of cardiovascular disease
dual boosted - protease inhibitor (pi) pharmacokinetics (pk) trial (tipranavir / ritonavir) in highly treatment-experienced hiv-1 infected patients

Conditions: HIV Infections

Summary: this is an open-label, randomized, parallel group pharmacokinetics trial of tipranavir/ritonavir (tpv/rtv), alone or in combination with rtv-boosted saquinavir (sqv), amprenavir (apv) or lopinavir (lpv), plus an optimized background regimen, in multiple antiretroviral (arv) experienced hiv-1 patients. the primary objective is to determine the safety and pharmacokinetics of: tpv/rtv given with an optimized background regimen (obr) and tpv/rtv given in combination with saquinavir, amprenavir, or kaletra® and an optimized background regimen (obr).


Eligibility criteria:
inclusion criteria: * signed informed consent prior to trial participation. * human immunodeficiency virus type 1 (hiv-1) infected males or females ≥18 years of age. * acceptable laboratory screening values in trial 1182.12 (resist 1) or 1182.48 (resist 2), excluding genotype. * genotypic resistance report from screening visit of study resist 1 or resist 2 indicating at least three mutations at protease codons 33, 82, 84, and 90. * at least 3 consecutive months experience taking arvs from each of the classes of nucleoside reverse transcriptase inhibitors (nrti), non-nucleoside reverse transcriptase inhibitor 1 (nnrti), and protease inhibitor (pi) at some point in treatment history, with at least 2 pi-based regimens, one of which must be part of the current regimen, and current pi-based anti-retroviral (arv) medication regimen for at least 3 months prior to randomization. * hiv-1 viral load ≥1000 copies/ml at screening. * further inclusion criteria apply. exclusion criteria: * anti-retroviral (arv) medication naïve. * patients on recent drug holiday, defined as off arv medications for at least 7 consecutive days within the last 3 months. * female patients of child-bearing potential who: * have a positive serum pregnancy test at screening or during the study, * are breast feeding, * are planning to become pregnant, * are not willing to a use barrier method of contraception, or * require ethinyl estradiol administration. * prior tipranavir use. * use of investigational medications within 30 days before study entry or during the trial. * further exclusion criteria apply.
diagnostic accuracy of salivary gamma-synuclein in oral malignant and premalignant lesions

Conditions: Oral Cancer; Oral Lichen Planus; Oral Leukoplakia; Premalignant Lesion

Summary: synucleins are a family of small, highly conserved proteins found in vertebrates and are specially abundant in neurons particularly in presynaptic terminals (surguchov et al., 2001). gamma-synuclein is the third member of the synuclein family, and is predominantly found in the cytosol of tumor cells and functions both intra- and extra-cellularly. it is involved in the pathogenesis of different types of cancer and some neurodegenerative diseases (liu et al., 2018). smoking - a major risk factor for oral cancer and its progression - and nicotine-containing products were found to time-dependently up-regulate the gamma-synuclein expression in cancer cells (hsu et al., 2020a). gamma-synuclein is released from tumor cells and was found to be elevated in tumors such as urinary bladder cancer (liu et al., 2016), colorectal cancer, gastric adenocarcinomas and esophageal cancer (liu et al., 2012). it is present in blood, serum, cerebrospinal fluid and saliva. the detection of extracellular synucleins in body fluids can reveal the first steps of the disease thus it can be used as a potential tool for early cancer detection (surguchov, 2016). this study aims to identify the diagnostic accuracy of gamma-synuclein in differentiating between oral malignant lesions and oral premalignant lesions.


Eligibility criteria:
inclusion criteria: group 1: patients with malignant lesions will be diagnosed through clinical and histopathological examination of tissue biopsy. group 2: patients with oral potentially malignant lesions will be diagnosed clinically and histopathological examination of tissue biopsy. group 3: healthy individuals who will be examined clinically through conventional visual and tactile examination to ensure no oral lesions are present and through thorough medical history exclusion criteria: -
the australian colonic advanced mucosal neoplasia and endoscopic resection study

Conditions: Colonic Polyps

Summary: to enhance understanding of the risk factors for amn, improve lesion assessment and prediction of submucosal invasive cancer, improve endoscopic resection efficacy, reduce complications of wf-emr and improve the understanding of the progression of large lesions to cancer

the australian colonic endoscopic mucosal resection study (ace), is a multicentre prospective observational study which examined wf-emr of colonic amn (ethics approval no. hrec jh/tg 2008/9/6.1(2858)). this project now has an extensive dataset from 8 leading colonic endoscopic resection centres in australia on more than 1500 lesions resected over 4 years since june 2008. the ace study has been successful in addressing several aspects of the resection of amn, resulting in several high profile papers in internationally recognised journals. the collection of this data has produced robust information on the efficacy of the procedure4, recurrence rates7, bleeding complications8 and mortality when compared to surgery5. single centre analysis of the ace dataset at westmead has also allowed insights into how to refine the procedure to improve outcomes. the target sign is now a recognised indication for the placement of clips to prevent perforation9, co2 insufflation for wf-emr has been shown to be superior to air insufflation10 and succinylated gelatin (gelofusine®) has been shown to be superior to normal saline as a submucosal lifting agent11. there remain a number of unanswered questions regarding the endoscopic resection of large sessile lesions and expanding the ace dataset in a new cohort of patients will allow these to be addressed. enhancing the prediction of submucosal invasive cancer, advanced lesion classification, refinement of the assessment of deep injury, submucosal injectate constituents, the optimum electrosurgical resection methods, prevention and prophylaxis of bleeding, and subtype analyses of the different histological groups comprising amn will be examined.

Eligibility criteria:
inclusion criteria: * patients referred for endoscopic resection of a large sessile colonic polyp or laterally spreading tumour ≥20mm in size. * age \> 18 years * able to give informed consent to involvement in the clinical study exclusion criteria: • unable to provide informed consent for involvement
using the phq-9 and gad-7 as feedback instruments in brief psychotherapy

Conditions: Depressive Symptoms; Anxiety States, Neurotic

Summary: this study will assess the effects of client feedback, using the patient health questionnaire - 9 and generalized anxiety disorder 7-item scale, on depression and anxiety in individuals undergoing brief psychotherapy. client feedback allows therapists to monitor treatment progress in real time. identifying an easily accessible treatment intervention, which utilizes commonly used scales, that potentially enhances the effect of brief psychotherapy and improves treatment outcomes is a valuable endeavor with clear implications for therapy practices. it is hypothesized that clients who complete these scales each session will show greater symptom improvement than clients who do not complete the scales.


Eligibility criteria:
inclusion criteria: * diagnosis of major depressive disorder, generalized anxiety disorder, or adjustment disorder exclusion criteria: * require a higher level of care than brief psychotherapy, or have been diagnosed with an intellectual disability, personality disorder, substance use disorder, or major medical illness
study of du-176b, prevention of venous thromboembolism in patients after hip fracture surgery

Conditions: Venous Thromboembolism

Summary: the objective of this study is to evaluate the safety and efficacy of du-176b compared with enoxaparin sodium for the prevention of venous thromboembolism in patients after elective hip fracture surgery.


Eligibility criteria:
inclusion criteria: * subjects who are scheduled to undergo surgery within 10 days for fracture of inner or outer femoral neck (trochanteric and subtrochanteric) exclusion criteria: * subjects with risks of hemorrhage * subjects with thrombolic risks * subjects who weigh less than 40 kg * subjects who are pregnant or suspect pregnancy, or subjects who want to become pregnant

Keywords: anticoagulants enoxaparin sodium venous thromboembolism. thromboembolism thrombosis deep vein thrombosis du-176b edoxaban factor xa hip fracture surgery embolism
a late phase ii study of kct-0809 in patients with dry eye syndromes

Conditions: Dry Eye Syndromes

Summary: the purpose of this study is to evaluate the efficacy and safety of kct-0809 compared to placebo in patients with dry eye syndromes.


Eligibility criteria:
inclusion criteria: * corneal and conjunctival damage * insufficiency of lacrimal secretion * ocular symptom exclusion criteria: * severe ophthalmic disorder * punctual plugs or surgery for occlusion of the lacrimal puncta

Keywords: dry eye syndromes corneal diseases conjunctival diseases
the effects of soft tissue therapy and exercise on hamstring tightness

Conditions: Hamstring Tightness; Myofascial Pain; Musculoskeletal Pain

Summary: the purpose of this study is to investigate the effects of myofascial decompression (cupping) and neurodynamic sliding technique for the hamstring on division i track and field athletes who complain of hamstring tightness. research questions will be: how do these techniques affect hamstring range of motion and flexibility; isometric strength of the hamstring muscle; muscle activation; and rate of force development. the hypotheses of this study are that neurodynamic sliding will have an effect on all variables and myofascial decompression will only have an effect on range of motion.

predisposing factors to hamstring injury include neural tension and muscle flexibility restrictions due to fascial adhesions. the sciatic nerve can produce symptoms of pain, decreased range of motion, and increased resting muscle tone when it is overstretched. the nerve can be overstretched after a hamstring injury and cause adhesions on the nerve and abnormal mechanosensitivity leading to perceived hamstring tightness.the purpose of this study is to investigate the effects of myofascial decompression (cupping) and neurodynamic sliding technique for the hamstring on division i track and field athletes who complain of hamstring tightness. research questions will be: how do these techniques affect hamstring range of motion and flexibility; isometric strength of the hamstring muscle; muscle activation; and rate of force development. the hypotheses of this study are that neurodynamic sliding will have an effect on all variables and myofascial decompression will only have an effect on range of motion.

Eligibility criteria:
inclusion criteria: * must be in the sprints, jumps, or multi (heptathlon, pentathlon, or decathlon) groups * complain of hamstring tightness and/or injury in the last calendar year * have less than 80⁰ for active knee extension test. exclusion criteria: * past history or current neurological disorders or orthopedic diseases * surgery of the lower extremity that involves an autograft on the tested leg * past history of hamstring surgery * receiving current treatment for a hamstring injury * received any form of myofascial therapy or neurodynamic techniques within the last week unhealed wounds * active tb * leukemia * hemophilia * thrombocytopenia * fever * influenza * moderate/severe anemia * high blood pressure * cardiac conditions * late stages of pregnancy

Keywords: hamstring tightness myofascial decompression cupping neurodynamic sliding
project u connect - optimizing brief alcohol intervention for underage drinkers in the er

Conditions: Alcohol Misuse

Summary: the emergency department (ed) setting is a unique point of access for reaching underage drinkers (age 14-20). with the aid of computer technology, this study will screen underage drinkers in the ed and fully test promising ed-based brief intervention and 3-month follow-up brief treatment approaches for alcohol misuse. developing methods to efficiently and effectively optimize these approaches has powerful public health implications for improving outcomes for underage drinkers.

the proposed study will use computerized screening using touchscreen computer tablets with audio (\~5,700 patients) and will test a developmentally appropriate, tailored intervention. specifically, 900 patients aged 14-20 in the ed who screen positive for problematic alcohol use in the past 3 months will be randomized to the combinations of three ed-based conditions: 1) computer brief intervention-cbi; 2) therapist/intervener delivered brief intervention-ibi; or 3) enhanced usual care-euc. all participants will be randomized to one of two follow-up conditions: 1) adapted motivational enhancement therapy-amet; or 2) enhanced usual care-euc that will take place 3 months post-ed. all participants will receive written information regarding community resources; individuals who meet alcohol use disorder criteria will additionally receive substance use treatment referrals. recognizing that brief interventions are important, but not necessarily sufficient, for change in all adolescents and young adults who misuse alcohol, the primary specific aims of the proposed study will determine the independent effectiveness of immediate "on-the-spot" ed-based brief intervention conditions, 3-month follow-up brief treatment conditions, and combinations of conditions, for decreasing alcohol use and improving health-related outcomes (including injury, mental health, and other risk behaviors) at 6- and 12-months follow-up.

Eligibility criteria:
inclusion criteria: inclusion criteria for screening: * (1) patients age 14-20 years presenting to the ummc ed for medical care * (2) ability to provide informed consent. * additional inclusion criteria for intervention based on "alcohol misuse": participants screening positive on the audit for problematic alcohol use in the past 3 months will be eligible for the randomized control trial. exclusion criteria: * (1) patients who do not understand english * (2) patients deemed unable to provide informed consent (e.g., mental incompetence, prisoners); * (3) adolescents ages 14-17 presenting without a parent/guardian; and * (4) patients treated in the ed for suicide attempts or sexual assault.

Keywords: alcohol use brief intervention risk behaviors
dupuytren´s disease study. primary disease, mcp joint, xiapex, pnf

Conditions: Dupuytren Contracture

Summary: aim: clinical rct comparing functional results and recurrence rate following enzymatic treatment vs. needle aponeurotomy. materials and methods: 30° or more contracture of only one metacarpophalangeal (mcp) joint contracture of one of the three ulnar digits and less than 20° for the adjacent proximal interphalangeal (pip) joint. patients with primary disease of the hand. total of 80 patients needed to detect difference of 13.5°. 1) needle aponeurotomy 2) clostridium histolyticum treatment. clinical follow ups 1,4 weeks, 16 weeks and 1,2 and 5 years. functional outcome scores: uram, quick dash, eq5d, brief mhq, vas pain and vas patient satisfaction. total passive extension contracture reduction, recurrence rate and registration of complications.

open surgery (fascieectomy) has traditionally been considered the gold standard of treatment for dupytren´s disease (dd) despite considerable risk of complications. there is an increasing interest in scandinavia in the treatment of dd with clostridium histolyticum (xiapex ®, auxillium). however the enzyme is expensive and long-term effects are not well documented. more studies are needed to analyze both short and long term clinical outcome as well as cost-benefit analysis. the treatment arm of xiapex in this study follows the recommendation as by the producer. the other treatment of dd contracture in this study is needle fasiotomy/aponeurotomy. we use multiple perforation technigue with 26 g needle needle, with as little local anesthesia (xylocin w adrenaline) as needed during contionus extension of the finger untill successfully extended. the two procedures leave little scar tissue lessening the challenges posed by the reoperations. recurrence rate of contracture following different treatments of dupuytren's disease differs widely in the literature, and the rate is influenced by multiple factors.

Eligibility criteria:
inclusion criteria: * primary dd disease (no earlier treatment for this condition of the hand involved) * single digit involvement, one of the three ulnar digits * average norwegian language skills. * mcpj contracture of 30 degrees or more and less than 20 degree involvement of the adjacent pipj * minimum 18 y.o. exclusion criteria: * involvement of 2 fingers/joints * earlier treatment for dd disease of the same hand, affection of addjecent pipj of 20 degrees or mor * pregnancy * ongoing treatment with platelet inhibitors * treatment with tetracycline 2 weeks prior to treatment date * poor norwegian language skills * participation in other studies 4 weeks prior or after treatment date * "need to treat" of both hands

Keywords: primary dd disase mcp joint
influenza vaccination among the elderly individuals

Conditions: Influenza

Summary: the aims of the study are to a) identify individuals with a poor response to influenza vaccination and b) identify factors associated with a poor response to influenza vaccination.

this is a population-based prospective cohort study. potential participants, males and females between 65 and 80 years of age, were selected randomly through the resident registration office in hannover city, germany and invited with a personalized letter to participate in the study. initially, a blood sample (40 ml) will be drawn from each participant (day 0). furthermore, participants will be vaccinated against influenza with fluad 2014/2015. fluad is a trivalent, surface antigen, inactivated influenza virus vaccine adjuvanted with mf59c.1. additional five blood samples will be collected during the study period of four months (at days 3, 7, 21, 70 and 130). information about current and past infections, chronic diseases and basic sociodemographic data will be collected through a self-administered questionnaire.

Eligibility criteria:
inclusion criteria: * individuals between 65 and 80 years of age exclusion criteria: * individuals with a known hypersensitivity to any of the excipients and to eggs, chicken protein, kanamycin and neomycin sulphate, formaldehyde, and cetyltrimethylammonium bromide * individuals, who have an acute infection during the visit at the study center * individuals with cognitive impairment * individuals already vaccinated with influenza vaccination in the influenza season 2014/15

Keywords: influenza vaccination elderly individuals prospective cohort study response
focal ablative stereotactic radiosurgery for cancers of the kidney

Conditions: Renal Cell Carcinoma

Summary: this study is evaluating the activity and efficacy of stereotactic ablative body radiotherapy (sabr) for the treatment of kidney cancers.

who is it for? * age \> 18 years old * all patients must have a biopsy confirmed diagnosis of renal cell carcinoma with a single lesion within a kidney * ecogperformance of 0-2 inclusive. * life expectancy \> 9 months * either medically inoperable, technically high risk for surgery or decline surgery. * multidisciplinary decision for active treatment study details: definitive external beam radiotherapy (ebrt) is often used to treat medically inoperable patients with cancers in many different organs, including the kidneys. however, renal cell carcinoma (rcc) is conventionally considered "radioresistant" to fully fractionated ebrt. in an effort to overcome the perceived "radioresistance" of rcc, severely hypofractionated ebrt in the form of stereotactic radiotherapy has renewed interest in the management of renal cell carcinoma with radiotherapy. this study will be evaluating the safety and effectiveness of stereotactic ablative body radiotherapy (sabr) for the treatment of cancers of the kidney. participants in this study will be allocated to receive either multi-fraction sabr (3 fractions over 2 weeks) or single fraction sabr (1 fraction only). all participants will be assessed at regular intervals post treatment in order to estimate the activity and efficacy of the technique, evaluate tolerability, estimate survival, estimate distant failure rate, and renal function change after sabr. the follow-up visits occur at 4 weeks and every 3 months in the 1st year post treatment, then every 6 months in the second year and then yearly until study closure (2 years after the last participant finishes study treatment).

Eligibility criteria:
inclusion criteria: * age \> 18 years old * all patients must have a biopsy confirmed diagnosis of renal cell carcinoma with a single lesion within a kidney * eastern cooperative oncology group (ecog) performance of 0-2 inclusive. * life expectancy \> 9 months * either medically inoperable, technically high risk for surgery or decline surgery. * multidisciplinary decision for active treatment exclusion criteria: * pre-treatment estimated glomerular filtration rate \< 30 mls/min * cytotoxic chemotherapy within 3 weeks of commencement of treatment, or concurrently with treatment. delivery of targeted agents (such as sunitinib) are allowable only when at least 7 days separate the delivery of the proposed agent and the delivery of the stereotactic radiotherapy. * previous high-dose radiotherapy to an overlapping region * tumours of larger than 8cm is size