Kornimate/medical-research-clean huggingface dataset:
epa supplementation in cancer patients receiving abdominal radiotherapy -

Conditions: Abdominal Cancer; Radiotherapy; Complications; Weight Loss; Energy Supply; Protein Deficiency

Summary: malnutrition occurs frequently in patients with cancer during and after radiotherapy to the gastrointestinal (gi) area and can lead to negative outcomes. n-3 fatty acids from fish, especially eicosapentaenoic acid (epa) may possess anticachectic properties. the aim of this study is to investigate the effect of two nutritional interventions; dietary counselling and an oral nutritional supplement (ons) containing 2.2 g of the n-3 fatty acid epa (forticare®) or standard care, including dietary counselling and protein supplementation when needed.

methods: outpatients commencing radiotherapy to the gi area due to dissiminated cancer are randomized to receive dietary counselling and daily fish-oil supplementation over a 5-7 week period, or standard care. outcome parameters are measured at baseline (onset of radiotherapy), week 5, and 12 weeks after commencing radiotherapy, with one additional measurement of body weight at week 2. quality of life (qol) is measured using the eortc qlq-c30 questionnaire. radiotherapy-related side effects are assessed using a questionnaire developed specifically for this study. data from a historical control group collected in a previous observational study is included in this study to compare incidence of weight loss.

Eligibility criteria:
inclusion criteria: * referred to radiotherapy for dissminated, abdominal cancer * \> 18 years of age * able to understand and comply with the intervention * willingness to participate after oral and written conscent exclusion criteria: * conditions precluding evaluations of end-points * dementia * operations planned in the observation period

Keywords: malnutrition radiotherapy, oral nutritional supplements fish-oil
real-world data on the effects of cardiac resynchronization therapy in adult patients with congenital heart disease

Conditions: Adult Congenital Heart Disease

Summary: this study aims to evaluate the real-world effects of cardiac resynchronization therapy (crt) in adult patients with congenital heart disease (achd). specifically, it seeks to determine whether crt improves clinical outcomes in this unique patient population and to identify factors associated with a favorable response to therapy.

cardiac resynchronization therapy (crt) is well-established in acquired heart failure, but evidence in achd remains limited. current guidelines, extrapolated from non-congenital populations, may not fully address the anatomical and electrophysiological complexities in achd. this retrospective cohort study aims to investigate the real-world efficacy and safety of crt in adult patients with congenital heart disease (achd). the study includes consecutive achd patients who underwent either de novo crt implantation or upgrade procedures, starting from january 2014. the primary objectives are to evaluate changes in qrs duration, systemic ventricular function, and new york heart association (nyha) functional class. the study aims to further examine the impact of crt in specific achd subgroups, including patients with systemic right ventricles (vs. systemic left ventricles), those with non-left bundle branch block (non-lbbb) morphology (vs. lbbb), and those with upgrade procedures (vs. de novo implants). data collection is based on retrospective review of electronic health records, including patient demographics, clinical characteristics, device-related procedural details, and follow-up data. outcomes are assessed using standardized echocardiographic and electrocardiographic measurements, alongside clinical evaluations. the study aims to provide comprehensive real-world insights into the efficacy and safety of crt in the diverse achd population and to identify predictors of favorable response, ultimately supporting more individualized decision-making in this complex patient group.

Eligibility criteria:
inclusion criteria: * achd patients who underwent crt implantation exclusion criteria: * less than 18 years old on the moment of crt implantation * patient objection to the use of retrospective data

Keywords: adult congenital heart disease cardiac resynchronization therapy achd crt heart failure hf
terahertz metamaterials for tumour marker concentration identification

Conditions: Malignant Tumour

Summary: the research the investigators plan to undertake involves the use of a metamaterial at terahertz frequencies. serum samples will be tested using the metamaterial to determine if this method can be used to measure the concentration of tumour markers present in the sample. patients who have been tested for cea, ldh, ca-125, ca 19-9, ca 15-3, total-hcg and afp will be used for both the positive and negative samples.

the research the investigators plan to undertake involves the use of a paper substrate with a gold metamaterial on top or a plastic substrate with gold metamaterial on top in physical contact with paper. the metamaterial has an absorption peak within the terahertz frequency range to be investigated (0.75 - 1.1thz). the serum samples will be soaked into the paper fibres which will shift the absorption peak within the terahertz frequency range dependent on the concentration of tumour markers present in the sample. the serum samples will be surplus from samples tested for cea, ldh, ca-125, ca 19-9, ca 15-3, total-hcg and afp at the durham and darlington nhs fondation trust. the samples will be anonymised with the exception of which tumour marker they were tested for and the level measured. there will be two stages to this research project the initial stage requires 15 samples per proposed marker including 15 samples (across all markers) for negative results. this will be used to identify suitable markers to consider for the second stage. where 50 to 90 samples of each qualifying marker will be tested dependent on the number required for statistical confidence in stage two with 10 to 18 negative samples required for each qualifying marker, again dependent on the statistical requirements for each marker.

Eligibility criteria:
inclusion criteria: * any patient recommended by their health professional to be tested for any of the tumour markers being studied at county durham and darlington nhs foundation trust for any reason. exclusion criteria: * patients with known bloodborne pathogens.

Keywords: tumour markers
effects of eccentric exercises on gait parameters in patellofemoral pain syndrome: a quasi-experimental study

Conditions: Patellofemoral Pain Syndrome

Summary: this study is a quasi experimental and the purpose of this study is to determine the effects of eccentric exercises on gait parameters in patellofemoral pain syndrome: a quasi - experimental study

the purpose of this study is to determine the effects of eccentric exercises on gait parameters in patellofemoral syndrome : a - quasi experimental study pain , gait parameters, rom and dynamic knee valgus angle of young adults (age : 18-35 years ) will be determined using: 1. numeric pain rating scale 2. goniometer 3. 30 meter walk test 4. dynamic knee valgus angle via kinovea software data will be before and after the intervention protocol for each participant. data collection procedure: participants of interest would be approached and explained about the research. informed written consent will be taken. pre and post intervention scores will be recorded.

Eligibility criteria:
inclusion criteria: * age 18-35 years * females * having pain from at least 2 months * pain score greater than 3 on nprs * retro patellar pain in at least two of the following activities: 1. ascending, descending stairs 2. hooping / jumping 3. prolonged sitting with flexed knees 4. kneeling and squatting * pain on palpation of medial or lateral patellar facet. * pain on palpation on anterior portion of medial or lateral femoral condyles. exclusion criteria: * diagnosed with chondromalacia patellae * instability of tibiofemoral joint * subluxation of patellofemoral joint * patellar instability * previous surgery of lower limb * negative findings on examination of knee ligaments, menisci and bursa.
streptococcus salivarius k12 for prevention and treatment of oral mucositis in patients undergoing radiotherapy

Conditions: Head and Neck Squamous Cell Carcinoma

Summary: to evaluate the efficacy and safety of streptococcus salivarius k12 for prevention and treatment of oral mucositis in patients undergoing radiotherapy for malignant head and neck tumors.

the goal of this clinical trial is to evaluate the efficacy and safety of streptococcus salivarius k12 in reducing the incidence, duration, and severity of severe oral mucositis (som). the main questions it aims to answer are whether streptococcus salivarius k12 can effectively prevent and treat radiation-induced oral mucositis and whether it will cause adverse events in patients undergoing radiotherapy. participants will be instructed to suck a streptococcus salivarius k12 or placebo lozenge three times daily from the beginning to the end of rt. after using the lozenges, the patients should avoid eating, drinking and conducting any oral hygiene activities for at least 1 hour. researchers will compare streptococcus salivarius k12 group and placebo group to see if oral probiotic are beneficial in preventing and treating oral mucositis in patients undergoing radiotherapy.

Eligibility criteria:
inclusion criteria: * patients with non-metastatic head and neck malignant tumor diagnosed by histopathology; * aged 18 to 80 years; * systemic functional status eastern cooperative oncology group (ecog) (appendix 1) rating ≤2; * receiving definitive rt or postoperative adjuvant rt at a dose of 60-72gy with/without concurrent chemotherapy; * sign the informed consent exclusion criteria: * patients with known allergy to probiotic or severe allergic constitution; * using antibiotics/antifungal drugs within 1 month or using antimicrobial mouthwash within 1 week before the study; * poor oral hygiene and/or severe periodontal diseases; * any previous rt to the head and neck region; * deemed unsuitable for the study by the investigators (concomitant with any other severe diseases).

Keywords: head and neck squamous cell carcinoma nasopharyngeal carcinoma oral mucositis streptococcus salivarius k12
the peer support study

Conditions: Neuromuscular Diseases

Summary: competent family caregivers (fc) are essential for successful caring for individuals with nmd. however, family caregiving is known to contribute to significant fc burden and social isolation, and negatively affects fc health. infrastructure to support fcs is paramount to ensure that individuals with nmd can safely remain at home. individuals with nmd have complex health problems, require a lot of care and they use the healthcare system often. covid-19 physical distancing has increased the care burden and social isolation for many fcs. infrastructure to support fcs is paramount to ensure that individuals with nmd can safely remain at home. peer support includes emotional and informational support by an individual that has experienced a similar health problem. it improves health-related quality of life, increases self-efficacy and empowerment, and decreases stress in various patient and caregiver populations. with our study we plan to educate and empower individuals with nmd and their caregivers and develop a comprehensive peer support program.


Eligibility criteria:
eligibility criteria for peer-support program: inclusion criteria 1. fc of individual with nmd that lives in canada; 2. speaks and reads english; 3. access to internet and computer/tablet. exclusion criteria: we will exclude those ventilator assisted individuals (vai) and caregivers, who are: 1. unable to communicate verbally in english 2. no access to internet and computer/tablet. eligibility criteria for peer mentors: inclusion criteria: 1. criteria 1-3 above; 2. completion of virtual peer support training; 3. identified by the hmv team or self-referral. exclusion criteria: we will exclude those vais and caregivers, who are: 1. unable to communicate verbally in english 2. no access to internet and computer/tablet.
identification of predictive factors for the response to anti-programmed cell death protein 1 (pd1) immunotherapy in head and neck squamous cell carcinoma

Conditions: Head and Neck Cancer

Summary: this project aims to organise the sampling of blood and tumor at key points of the standard of care of patients with recurrent or metastatic squamous-cell carcinoma of the head and neck (hnscc). this will allow to identify new potential predictive biomarkers of efficacy of immunotherapy and to investigate the evolution of the tumoral microenvironment after successive systemic treatments.

tumor and blood samples will be collected on patients treated by anti-pd1 immunotherapy at different timepoints. tumor samples will be collected (i) before initiation of immunotherapy, (ii) at 50 days after initiation of immunotherapy and, optionally, in case of disease progression, (iii) before the initiation of the new line of chemotherapy and (iv) at 50 days after initiation of chemotherapy. blood samples will be collected : (i) before initiation of immunotherapy, (ii) at each cycles of treatment until 84 days after initiation of immunotherapy and, optionally, in case of disease progression, (iii) before the initiation of the new line of chemotherapy and (iv) at each cycle until 50 days after initiation of chemotherapy (maximum 2 samples per month).

Eligibility criteria:
inclusion criteria: * patients with recurrent squamous-cell carcinoma of the head and neck not amenable to local therapy and/or with metastatic disease * tumor directly accessible to clinical examination (tumor of oral cavity and of oropharynx) and/or cervical lymphadenopathy accessible to echography allowing to realise biopsy under local anesthesia * indication to treatment by anti-pd1 immunotherapy according to french competent authority recommendations * performance status 0, 1 or 2 * at least one measurable lesion on recist v1.1 criteria exclusion criteria: * head and neck squamous cell carcinoma accessible to a local treatment * cancer of nasopharynx, sinus or nasal cavity * other histology than epidermoid * patients with contraindication for anti-pd1 immunotherapy
acute lymphoblastic leukemia relapse in sweden 2003-2007

Conditions: Acute Lymphoblastic Leukemia

Summary: a minority of patients with adult acute lymphoblastic leukemia (all) relapse are rescued. the aim of this population-based study was to assess the results of reinduction treatment and allogeneic stem cell transplantation (sct) in second complete remission (cr) in sweden 2003-2007.

this is a national, multicenter, prospective, population-based study of outcome among adult patients aged 19 to 65 years with all relapse diagnosed during 2003-2007 in sweden. most of the patients had primary treatment according to national guidelines for all as recommended by the swedish adult all group (svall). the guidelines suggest two different treatment protocols for early relapses, and retreatment according to the initial therapy for late relapses, with the intention to proceed to allogeneic sct in cr2 for eligible patients. the aim of the current study was to assess outcome among adult patients after first all relapse, and the utilization and efficacy of recommended protocols and of allogeneic sct in this setting.

Eligibility criteria:
inclusion criteria: * adult patients with first relapse of all exclusion criteria: * patients with burkitt leukemia

Keywords: acute lymphoblastic leukemia relapse salvage prognostic
efficacy and safety between different dilution of insulin

Conditions: Hyperglycemia

Summary: hyperglycemia associated with insulin resistance is common in critically ill patients, even in those nondiabetic patients. hyperglycaemia or relative insulin deficiency (or both) during critical illness may directly or indirectly confer a predisposition to complications, such as severe infections, polyneuropathy, multiple-organ failure, and death. tight glycaemic control in adult long-stay critically ill patients using intensive insulin therapy reduces absolute mortality. it has been reported that pronounced hyperglycemia may lead to complications in such patients, although data from controlled trials are lacking. however, target glycaemia may be difficult to achieve in clinical practice. insulin adsorption onto infusion equipment (e.g., infusion tubing) may affect glucose control, possibly leading to hyperglycemia. in the use of low-level intravenous insulin infusion for treating diabetic hyperglycaemia and ketoacidosis adsorption of insulin to containers or plastic infusion apparatus results in significant losses of 60-80% of insulin in dilute physiological saline solution. problem statement \& study rationale up to my knowledge, there is no study that demonstrate differences between types of dilution for insulin infusion in icu patient in malaysia; thus, this study is aimed to evaluate it. in 2001 it has been reported that intensive insulin therapy (iit) in surgical intensive care unit (icu) patients was associated with reduction in mortality and morbidity as well as other associated factors. there is limited study in comparing dilution of insulin in normal saline and other types of diluents. other than that, it is important to know which diluent the best is to choose for the management of hyperglycaemia in icu patient.


Eligibility criteria:
inclusion criteria: 1. patient admitted to icu hospital usm regardless of whether patient intubated or not. 2. adult patient 18 years old and above. 3. 2 consecutive blood sugar more than 10 mmol/l including patient with diabetic ketoacidosis and hyperosmolar hyperglycaemic state. 4. within 12 hours from admission. 5. patient not in high inotropic support and with apache ii score less than 17. exclusion criteria: 1. pregnancy. 2. history of any allergic from previous gelafundin infusion or known patient to have allergic towards gelafundin (allergic card, or information from relatives) 3. post cardiac arrest or prolonged resuscitation. 4. patient with cardiogenic shock.

Keywords: insulin hyperglycemia diluent plastic syringe
adjusted fibrinogen replacement strategy

Conditions: Bleeding Disorder; Hypofibrinogenemia; Acquired

Summary: the main purpose of this study was to demonstrate the efficacy and safety of intraoperative use of fibrinogen concentrate bt524, as a complementary therapy for the management of uncontrolled severe hemorrhage in acquired hypofibrinogenemia. this non-inferiority study focused on the primary objective of demonstrating that bt524 is non-inferior that means not worse than the comparator fresh frozen plasma/cryoprecipitate in reducing intraoperative blood loss when administered intravenously in subjects with acquired hypofibrinogenemia undergoing elective major spinal or abdominal surgery.

fibrinogen is the first coagulation factor to become critically reduced during intraoperative bleeding. therefore, rapid supplementation of fibrinogen to restore physiological plasma levels is an important component in achieving and maintaining hemostasis in bleeding patients. in this study, subjects with major blood loss during elective spinal surgery or abdominal surgery were randomized to receive either intravenous transfusion of the fibrinogen concentrate bt524, or fibrinogen-containing fresh frozen plasma/cryoprecipitate as first hemostatic intervention to rapidly replenish fibrinogen and control bleeding.

Eligibility criteria:
inclusion criteria: at screening: 1. written informed consent 2. subjects scheduled for elective major spinal surgery or cytoreductive pseudomyxoma peritonei (pmp) surgery with expected major blood loss 3. male or female, aged ≥ 18 years 4. no increased bleeding risk as assessed by standard coagulation tests and medical history intra-operative: 5. 1. subjects who underwent spinal surgery: intra-operative clinically relevant bleeding of approximately 1 liter, requiring hemostatic treatment during surgery. 2. subjects who underwent cytoreductive pmp surgery: intra-operative prediction of clinically relevant bleeding of more than 2 liter, requiring hemostatic treatment during surgery exclusion criteria: 1. pregnancy or unreliable contraceptive measures or breast feeding (women only) 2. hypersensitivity to proteins of human origin or known hypersensitivity reactions to components of the investigational medicinal products (imp) 3. participation in another clinical study within 30 days before entering the study or during the study and/or previous participation in this study 4. treatment with any fibrinogen concentrate and/or fibrinogen-containing product within 30 days prior to infusion of imp 5. employee or direct relative of an employee of the contract research organization (cro), the study site, or biotest 6. inability or lacking motivation to participate in the study 7. medical condition, laboratory finding (e.g., clinically relevant biochemical or hematological findings outside the normal range), or physical exam finding that in the opinion of the investigator precludes participation 8. presence or history of venous/arterial thrombosis or thromboembolic event (tee) in the preceding 6 months

Keywords: fibrinogen
style - symbicort single inhaler therapy vs conventional therapy in treatment of persistent asthma

Conditions: Asthma

Summary: the purpose of the study is to compare the efficacy of a flexible dose of symbicort with conventional stepwise treatment according to asthma treatment guidelines in patients with persistent asthma


Eligibility criteria:
inclusion criteria: * - diagnosis of asthma ³ 3 months * prescribed daily use of glucocorticosteroids at a dose \> 320 mcg/ day for at least 3 months prior to visit 1 exclusion criteria: * smoking history \> 10 pack-years * asthma exacerbation requiring change in asthma treatment during the last 14 days prior to inclusion * any significant disease or disorder that my jeopardize the safety of the patient. additional inclusion and exclusion criteria will be evaluated by the investigator.
effectiveness of hepatitis a virus vaccination among homosexual males at risk for hepatitis a infection

Conditions: Hepatitis

Summary: male homosexuals are at risk for hepatitis a virus (hav) infection, and hav vaccination has been recommended to prevent hav infection in male homosexuals. hiv infection may impair serological responses to hav vaccination in hiv-infected patients. the investigators hypothesize that 3 doses of hav vaccine will improve serological responses to hav vaccine in hiv-infected patients.

in this study, we aim to compare the serological responses to hav vaccination between hiv-infected patients who receive 2 doses or 3 doses of hav vaccine and hiv-uninfected persons who receive 2 doses of hav vaccine. persons who identify themselves as male homosexuals aged younger than 40 years and are seronegative for hepatitis a virus will be enrolled. hav vaccination will be provided free-of-charge. hiv-uninfected persons will receive 2 doses of hav vaccine that will be administered at baseline and 6 months after the first dose, while hiv-infected patients will be given 2 doses or 3 doses of hav vaccine; for those who choose to receive 3 doses, a second dose will be given 1 month after the first dose. a longitudinal follow-up of serological responses will be conducted to assess the effectiveness of hav vaccination; hav igg will be determined at 6 months after the first dose of hav vaccination(before the administration of the second dose), 12 months and 18 months after the first dose of hav vaccination .

Eligibility criteria:
inclusion criteria: * age between 18\~40-years-old * homosexuals exclusion criteria: * presence of symptoms or signs suggestive of active infection * allergy to vaccination * failure to provide written informed consent * use of immunosuppressive or immunomodulating agents or chemotherapy

Keywords: hepatitis a vaccine male homosexual hiv infection male homosexuals who are seronegative for hepatitis a virus