Kornimate/medical-research-clean huggingface dataset:
the amputation surgical site infection trial (assit)

Conditions: Wound Infection; Amputation Wound

Summary: * lower limb amputations are performed usually as a last resort in patients with acute and chronic limb ischaemia (cli) caused by vascular disease, poorly controlled diabetes or, infection. * in the period 2003-2008 there were approximately 5,000 amputations per year in the uk. * the centre for disease control defines a surgical site infection (ssi) as an infection within 30 days of an operation or up to one year if an implant is left in place and the infection is related to an operative procedure. * figures from the surgical site infection surveillance reported that the highest rate of surgical site infection was reported in association with lower limb amputation at 13.1%. * there is a clear under-representation and the infection rate within our institution is approximately 25% which reflects the infection rate reported in a recent trial by sadat et al (22.5%) * prevention of surgical site infections is of paramount importance to patients, healthcare providers and policy-makers, as they impact on morbidity and mortality and have significant time and cost implications. * currently there is no consensus as to what the best practice is towards antibiotic administration in such patients. from a questionnaire-based audit we performed including vascular departments across the entire country, practice varies in both course duration (single dose → 5 days antibiotic course) as well as choice of antibiotics. * the guideline at our institution suggests the 5-day course of antibiotic prophylaxis. the course duration varies depending on the clinical picture as well as microbiology results and recommendations. * there are no randomised control trials that have investigated this aspect of patient care. we have set up one such trial and through it, we are looking to establish a standard practice which will hopefully be as beneficial as possible to the patient but also cost-effective for nhs.

as above

Eligibility criteria:
inclusion criteria: 1. adults ≥18 yrs undergoing lower limb amputations who are able to consent to the trial. 2. able to understand the patient information sheet and capable and willing to give informed consent and follow the protocol requirements (including attending all follow-up visits) exclusion criteria: 1. allergies to chlorhexidine/ alcohol/ iodophors 2. inability to give informed consent 3. patients who are admitted to hospital with severe sepsis secondary to gas gangrene requiring multiple operations and admission to intensive care unit. 4. aged under 18 years at the time of recruitment 5. use of investigational drug/device therapy within preceding 4 weeks that may interfere with this study. 6. toe amputations

Keywords: amputation infection skin preparation ssi stump wound
study of amg531(romiplostim) in patients with aplastic anemia

Conditions: Aplastic Anemia

Summary: to evaluate the hematological responses based on the response assessment criteria when amg531 is subcutaneous (sc)-administered with anti-human thymocyte immunoglobulin (atg) + ciclosporin a (csa) therapy for 6 months in patients with aplastic anemia (aa) who were previously untreated with immunosuppressive therapy.


Eligibility criteria:
inclusion criteria: 1. voluntary signed informed consent to participate in the study; 2. a diagnosis of aa confirmed by blood and bone-marrow examinations, etc.; 3. considered to require new treatment with atg and csa provided that nsaa must be platelet or erythrocyte transfusion-dependent. 4. an eastern cooperative oncology group (ecog) performance status (ps) score of 0 to 1at screening exclusion criteria: 1. previously treated with atg, csa, or alemtuzumab; 2. diagnosed as having congenital aa (fanconi anemia, congenital dyskeratosis, etc.); 3. diagnosed as having aml or chronic myelomonocytic leukemia; 4. concurrent thrombocytopenia of other etiologies (e.g., mds, itp, cirrhosis); 5. concurrent active infection not adequately responding to appropriate therapy; 6. concurrent clinically significant illness(es) items which are deemed by the investigator to be likely to affect the study conduct and assessments. 7. having active malignancies, or having a history of treatment of malignancies within 5 years prior to informed consent. 8. concurrent pnh 9. having grade 2 or higher bone marrow reticulin based on bone marrow pathology (2nd edition) ; 10. history of chromosome aberrations discovered in bone marrow cells. 11. having blast cells \> 2% in bone marrow; 12. positive for anti-human immunodeficiency virus (hiv) antibody; 13. receiving prophylactic or therapeutic treatment for hepatitis type b 14. positive for hepatitis c virus (hcv) antibody, and hcv infection being confirmed 15. planned hematopoietic stem cell transplantation during the study; 16. systemic treatment with any of the following medication for the treatment of aa within 4 weeks before day 1, however, excluding their use as premedication: * anabolic steroids * corticosteroids; 17. pregnant or breastfeeding women, or women willing to become pregnant; 18. other conditions unsuitable for participation in the study in the opinion of the investigator.

Keywords: aplastic anemia romiplostim
non invasive prenatal test of rare genetic diseases: application to rare intellectual disabilities

Conditions: Genetic Disorders in Pregnancy

Summary: the aim of this study is to evaluate performances of a nipt test based onto the study of the maternal blood to search known genetic mutations already detected in the family and potentially inherited by the fetus. this test will avoid an invasive prenatal diagnosis in those families with a known genetic risk. the performance of this test will be evaluated in terms of sensitivity and specificity with an adapted statistic model. secondary objectives of the protocol are * to adapt nipt to small dna quantity (5-50 ng) * to adapt bioinformatics pipeline to low rate of mosaicism * to develop a tool to quantify the fetal fraction * to evaluate the robustness of the method this test is based onto capture and high throw put sequencing adapted to cell free plasmatic dna of pregnant women in order to detect point mutation present in her fetus. this approach has been previously described for others clinical applications such as liquid biopsy in cancers but not for nipt analysis.


Eligibility criteria:
inclusion criteria: * couple (father, mother) \> 18 ans * pregnant woman (\> 12-15 weeks of gestation) with a fetal sampling needed in standard care. * informed consent obtained * couple affiliated to the social insurance in france exclusion criteria: * dna extraction failure * absence of informed consent * father or mother placed under judicial protection or under guardianship or tutorship
tomosynthesis use in detecting subtle occult hip fractures

Conditions: Hip Fracture

Summary: the purpose of this project is to determine if using tomosynthesis, in conjunction with x-ray, is better at detecting hip fractures than using x-ray alone. the goal of this study will be to include the use of tomosynthesis with x-ray as usual practice when a patient comes to the emergency room with symptoms of a hip fracture.


Eligibility criteria:
inclusion criteria: * men and women aged \> 18 years who/se: * present at the er with a possible hip fracture and * have a negative x-ray for a hip fracture * physician has a high clinical suspicion of a hip fracture * provide provision of informed consent exclusion criteria: * hip prosthesis on the same side of the suspected hip fracture * other serious medical illness that is likely to interfere with study participation * significant psychiatric illness, senility, dementia, alcohol or substance abuse, which could impair the ability to provide informed consent and to adhere to the trial procedures * pregnant or suspected pregnancy

Keywords: hip fracture tomosynthesis x-ray emergency room
correlation between optical coherence tomography angiography and photopic negative response in patients with glaucoma

Conditions: Open Angle Glaucoma

Summary: open angle glaucoma (oag) is considered a common cause of irreversible vision loss worldwide. it is an optic neuropathy associated with progressive loss and degeneration of the retinal ganglion cell layer (rgc) and its axons (retinal nerve fiber layer; rnfl), which lead to neuroretinal rim excavation and corresponding visual field defects.

open angle glaucoma (oag) is considered a common cause of irreversible vision loss worldwide. it is an optic neuropathy associated with progressive loss and degeneration of the retinal ganglion cell layer (rgc) and its axons (retinal nerve fiber layer; rnfl), which lead to neuroretinal rim excavation and corresponding visual field defects. oct angiography (octa) is a promising tool for diagnosing and monitoring glaucomatous patients. it can evaluate glaucomatous damage and assess the ganglion cells' health by measuring blood flow within the optic nerve and the retina correlation between vascular , structural and functional changes of the peripapillary retinal nerve fiber (rnfl) and macular/ganglion cell complex (gcc) can lead to early detection of glaucomatous changes.

Eligibility criteria:
inclusion criteria: * age of 30 years or older for both control and glaucoma groups. * spherical equivalent (se) between -2 and +2 d. * no history of previous eye surgery, trauma, or systemic diseases. exclusion criteria: * spherical equivalent greater than +/- 2.00 diopters (d). * media opacity as (cataract or corneal scar). * any history of ocular surgeries or trauma. * optic nerve anomaly or other retinal diseases. * unreliable visual field tests (33% fixation losses, false positive, and false- negative results).

Keywords: open angle glaucoma optical coherence tomography photopic negative response
early outcomes and nutritional scores in bariatric patients

Conditions: Postoperative Complications; Preoperative Nutritional Markers

Summary: this prospective observational study aims to evaluate whether preoperative immune-nutritional markers-specifically the prognostic nutritional index (pni), halp score, neutrophil-to-lymphocyte ratio (nlr), and c-reactive protein (crp)-can predict early postoperative clinical outcomes such as time to oral intake, mobilization, complications, and length of hospital stay in patients undergoing elective laparoscopic sleeve gastrectomy.


Eligibility criteria:
inclusion criteria: * age between 18 and 65 years * body mass index (bmi) ≥ 35 kg/m² * scheduled for elective laparoscopic sleeve gastrectomy * availability of complete preoperative laboratory test results * signed informed consent exclusion criteria: * severe hepatic or renal dysfunction * presence of active infection * history of immunosuppressive therapy or hematologic malignancy * need for intensive care unit (icu) admission within the first 72 hours postoperatively * preoperative administration of albumin or blood products
12-week open-label evaluation of efficacy and safety of indacaterol

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: in this 12-week study, patients were randomized to either open-label indacaterol or standard of care for chronic obstructive pulmonary disease (copd) treatment; efficacy and safety were assessed.


Eligibility criteria:
inclusion criteria: * diagnosis of chronic obstructive pulmonary disease (copd) (moderate-to-severe as classified by the global initiative for chronic obstructive lung disease (gold) guidelines, 2007) and: * post-bronchodilator forced expiratory volume in 1 second (fev1) \<80% and ≥30% of the predicted normal value * post-bronchodilator fev1/fvc (forced vital capacity) \<70% * current copd bronchodilator treatment that includes a laba bronchodilator or a fixed dose combination of laba and inhaled corticosteroid (ics) exclusion criteria: * patients with a history of asthma * patients who are currently being treated for copd with tiotropium (spiriva®) * patients with diabetes type i or uncontrolled diabetes type ii * patients with a history of certain cardiovascular comorbid conditions other protocol-defined inclusion/exclusion criteria may apply

Keywords: indacaterol copd long-acting beta2-agonist (laba)
health expenses and outcomes of the dash diet in egyptian patients with hypertension

Conditions: Hypertension,Essential

Summary: dash diet can reduce hypertension and decrease health expenses

hypertension is a prevalent cardiovascular risk factor associated with adverse outcomes and obesity. egypt's prevalence is 26.3%, exceeding rates in the u.s. and sub-saharan africa. lifestyle interventions like the dash diet effectively manage hypertension, offering a cost-effective alternative to pharmacological treatments. this study aims to assess the effects of the dash diet on blood pressure, bmi, waist circumference, and fasting blood glucose, as well as its cost-effectiveness compared to pharmacological treatments. this open-label prospective controlled clinical trial was conducted in esna health administration, luxor governorate. the fmrec of beni-suef university approved the study, which included 364 hypertensive patients aged 30-60. exclusions were patients with severe comorbidities or those who declined participation. measurements included height, weight, bmi, blood pressure, and laboratory tests. the intervention group received a dash diet education program. outcomes measured were blood pressure, bmi, waist circumference, weight, and fasting blood glucose at baseline and post-intervention. our study demonstrates the significant benefits of the dash diet in managing blood pressure, weight, and fasting blood glucose levels in the egyptian population. the dash diet substantially reduced systolic and diastolic blood pressure, with a notable decrease in the number of antihypertensive medications needed. additionally, participants on the dash diet experienced significant weight loss and reduced bmi and waist circumference compared to the control group. the economic implications of the dash diet are also promising, with a notable decrease in the total cost of therapy due to reduced medication costs.

Eligibility criteria:
inclusion criteria: * patients diagnosed with primary hypertension (all stages) in the family medicine units of esna health administration, located in luxor governorate. * individuals between the ages of 30 and 60, of both male and female genders. exclusion criteria: * • patients with cancer and either hepatic failure or renal impairment. * patients diagnosed with diabetes, metabolic illness, or terminal organ failure. * a patient with severe or malignant hypertension. * individuals who decline to partake in our research.

Keywords: dash diet hypertension health expense
diagnostic accuracy of human transcriptional activator(myb) expression by elisa technique versus immmunohistochemistry in detecting salivary gland carcinomas

Conditions: Malignant Neoplasm of Salivary Gland; Benign Neoplasm of Salivary Gland

Summary: in this resarch we will use elisa technique to estimate human transcriptional activator(myb) expression .compare it by immmunohistochemistry analysis of myb expression in the malignant and benign salivary gland tumor


Eligibility criteria:
inclusion criteria: . * patients with clinically evident salivary gland tumors; malignant tumors will be recruited in group i * benign tumors will be recruited in group ii. exclusion criteria: * subjects taking any drugs inducing any changes that could affect the salivary glands. * pregnant females. * subjects having any allergies, infectious or autoimmune diseases. * subjects having any metabolic disorders that can be manifested with salivary gland swelling as diabetes mellitus.
the safety, acceptability and efficacy of alena

Conditions: Social Anxiety; Social Anxiety Disorder; Social Anxiety Disorder (Social Phobia)

Summary: the present study is a randomised controlled trial that seeks to investigate the safety, acceptability and efficacy and safety of the alena cbt programme as a treatment for social anxiety disorder.

this is a 6-week web-based parallel-group unblinded randomised controlled trial with a 4-week intervention period and a 2-week follow-up post intervention. participants are randomly allocated to receive access to the alena cbt programme or to a wait list control group, in a 1:1 ratio. the programme consists of cbt-based therapy for social anxiety based on the clark and wells model.

Eligibility criteria:
inclusion criteria: * female * aged between 18 and 35 years old (inclusive) * located in the uk * fluent in english * comfortable taking part in a study that included deception (due to the nature of the cognitive assessments) * had an iphone and daily access to an internet connection * scored over 30 on the social phobia inventory (spin; indicating at least moderate social anxiety). exclusion criteria: * currently undergoing any mental health therapy * changed the usual mental health medication or dosage within the past eight weeks * scored eight or above on the alcohol use disorders identification test for consumption (audit-c; indicating higher risk of alcohol dependence) * scored two or above on the adapted drug questions (indicating higher risk of drug dependence) * had previously participated in scientific studies or user research undertaken by alena

Keywords: rct cbt
pediatric liver fat quantification (lfq) phase 2 pilot study

Conditions: Non-Alcoholic Fatty Liver Disease; Non-Alcoholic Steatohepatitis

Summary: this clinical study will involve performing a series of medical imaging procedures of the abdomen using both ultrasound and mri modalities in subjects at risk for or already diagnosed with nonalcoholic fatty liver disease (nafld). the primary objective of this clinical study is to evaluate the clinical feasibility of an investigational ultrasound technique for quantifying liver fat by comparing specific ultrasound-derived biomarkers with the liver fat percentage obtained from mri proton density fat fraction (mri-pdff) measurements. all subjects enrolled in this study will undergo one investigational abdominal ultrasound examination using the philips epiq ultrasound system and one mri pdff examination according to the clinical standard of care.


Eligibility criteria:
inclusion criteria: * subjects at least 5 years old up through and including 21 years old who are able to provide informed consent to participate or have a legal representative/parent/legal guardian who is able to provide informed consent for the subject to participate. * subjects must be eligible for a standard abdominal ultrasound examination and standard non-contrast mri examination. in addition, at least one of the following criteria must also be met: * overweight or obese (bmi-for-age ≥ 85th percentile). * diagnosed with type 2 diabetes per standard clinical guidelines. * diagnosed with hypercholesterolemia per standard clinical guidelines. * diagnosed with or clinically suspected of having nafld/nash based on previous medical record, medical imaging, liver biopsy, and/or laboratory testing. exclusion criteria: * history of moderate/heavy/binge alcohol consumption exceeding niaaa guidelines. * evidence of hepatotoxicity or cirrhosis in the clinical judgment of the investigator. * history of chronic liver disease other than nafld (e.g., viral, cholestatic, or autoimmune). * use of drugs associated with hepatic steatosis: * amiodarone * methotrexate * nucleoside reverse transcriptase inhibitors (didanosine, stavudine) * valproic acid * dexamethasone * tamoxifen * 5-fu-based adjuvant chemotherapy * apo-b inhibitors (mipomersen, lomitapide) * tetracycline exceeding 2 g/day * acetylsalicylic acid exceeding 150 mg/kg

Keywords: liver fat quantification ultrasound liver disease digestive system disease
connective tissue grafting for single tooth recession & the impact of the thickness of the palatal harvest tissue

Conditions: Gingival Recession

Summary: the purpose of this study is to test if the thickness of the graft taken from the roof of the mouth, has a significant effect on the amount of attached tissue and the amount of root coverage that are attained when treating a single tooth with gingival recession.

the goal of the study is to determine if the thickness of a tissue graft taken from the roof of the mouth, used to cover the exposed root of a tooth, affects the overall outcome of the root coverage, the health of the resulting tissue, as well as postoperative pain as reported by the patient. connective tissue grafts will be harvested in different thicknesses, and results of the procedures will be compared. qualified subjects will undergo a root coverage procedure, after random assignment to one of the groups. regular recall visits to monitor healing at intervals of 1 week, 2 weeks, 1 month, and 3 months will be scheduled. subjects will be asked to fill out patient response forms regarding pain and other symptoms at these visits. photographs will be taken.

Eligibility criteria:
inclusion criteria: 1. age\>18 years old 2. absence of active periodontal disease 3. single tooth (premolars and anterior teeth) with miller class i or ii gingival recession \>= 2mm 4. detectable cemento-enamel junction (cej) - exclusion criteria: 1. smokers (\>10 cigarettes/ per day) 2. uncontrolled systemic diseases with compromised healing potential (dm with hba1c \>7%) 3. active infectious diseases (hepatitis, tuberculosis, hiv, etc.) 4. medication known to cause gingival enlargement 5. patients taking anticoagulants with an international normalized ratio (inr) \>2.5 6. long-term (\>2 weeks) use of antibiotics in the past 3 months 7. pregnant or attempting to get pregnant 8. sites with probing depth \> 4mm 9. recession adjacent to an edentulous area 10. frenal and muscle attachment that encroach on the marginal gingiva a. can be included 2 months after surgical therapy to remove the frenum (frenectomy) 11. history of periodontal surgical treatment of the involved sites 12. prosthetic crown, restorations or caries in the candidate tooth and adjacent teeth 13. teeth with pulpal pathology 14. severe teeth malposition and open contacts 15. planned orthodontic treatment to commence within 1 year following procedure 16. parafunctional habits -

Keywords: gingival recession