Kornimate/medical-research-clean huggingface dataset:
postoperative cognitive dysfunction after total knee or hip replacement surgery in fast-track set-up

Conditions: Postoperative Cognitive Dysfunction

Summary: the aim of this study is to quantify the incidence of postoperative cognitive dysfunction in the elderly patient (\>60y) after total hip or knee replacement surgery. the hypothesis is that the fast-track methodology with a mean hospital stay less than 3 days will help to minimize this reduction in memory and concentration.


Eligibility criteria:
inclusion criteria: * 60 years of age or above * asa classification 1-4 * undergoing fast-track hip or knee replacement exclusion criteria: * anaesthesia within the past 90 days * daily consumption of sleep or anxiety medication * more than 35 units of alcohol per week * lack of proper verbal and reading skills, danish * serious hearing or visual impairment * mini mental status evaluation (mmse) \< 24 * parkinsons disease or other neurological disease causing functional impairment
hpv in adolescents

Conditions: HPV Infection; Cervical/Anal Dysplasia

Summary: this study will assess the prevalence of hpv infection in perinatally hiv-infected adolescents, intraepithelial neoplasia, and e6e7 biomarker at cervical and anal sites.

human papillomavirus (hpv) is the most common sexually transmitted disease and it causes cervical and anal cancer. prevalence and incidence of hpv infection among young adults who are sexually experienced is high. no data exist for hiv-positive adolescents in regards to hpv infection, cervical and anal intraepithelial neoplasia. this study will compare the prevalence of hpv infection, intraepithelial neoplasia and e6/e7 biomarker at cervical and anal sites among perinatally hiv-infected adolescents, behaviorally hiv-infected adolescents, and hiv-negative adolescents.

Eligibility criteria:
inclusion criteria: * perinatally-infected (documented positive hiv enzyme immunoassay (eia) or nucleic acid testing (nat) at any time and history of maternal hiv infection) * behaviorally-infected (documented positive hiv enzyme immunoassay (eia) or nucleic acid testing (nat) at any time after sexual debut without history of maternal hiv infection) * female with vaginal or receptive anal intercourse with a male or male with receptive rectal intercourse with another male * signed informed consent. volunteers aged 12-17 years can decide whether they wish for their parents to consent for their participation. due to the confidential nature of the issues being studied, parental consent may be exempted exclusion criteria: * have any conditions that may interfer with subjects' ability to understand and consent to the study

Keywords: hpv hiv cervical/anal dysplasia intraepithelial neoplasia e6/e7 biomarker perinatally hiv-infected adolescents behaviorally hiv-infected adolescents anal and pap smear
correlation of ultrasonographic lesion type characterization with angioplasty outcomes in failing dialysis avfs

Conditions: Dialysis Access Malfunction

Summary: the continuous increase in the incidence of end stage renal disease and hemodialysis patients, has raised the interest of the vascular access scientific community and many researchers are currently investigating the potential mechanisms of arteriovenous fistulas (avf) dysfunction. roy-chaudhury et al. were the first to suggest neointimal hyperplasia (nih) as the main reason of avf dysfunction and vessel negative remodeling as another important factor. first, yamamoto et al. described 3 stenotic lesions categories of arteriovenous grafts (avg) observed by ultrasonography: 1. vascular constriction type, 2. neointimal hyperplasia type, 3. mixed type (constriction and neointimal hyperplastic type). the main goals of this prospective observetional study are: * the characterization of avf stenotic lesions by ultrasonography * the correlation of the stenotic lesion type with the outcomes of percutaneous transluminal angioplasty and the rate of reintervention.

this is a prospective, observetional study designed to investigate the correlation of stenotic lesion type characterization (1. vascular constriction type, 2. neointimal hyperplasia type, 3. mixed type eg. constriction and neointimal hyperplastic type) using duplex ultrasound, with the outcomes of high pressure plain balloon angioplasty. in total 200 patients with failing dialysis arteriovenoyus fistula (avf) scheduled to undergo angioplasty of stenotic lesion(s) will be included. the study's primary endpoint will be the correlation between stenotic lesion type and target lesion re-intervention due to clinical recurrence at 6 months follow up.

Eligibility criteria:
inclusion criteria: * patiens with failing avf scheduled to undergo fluoroscopically-guided high-pressure balloon angioplasty * signed study concent form exclusion criteria: * patients undergoing dialysis via arteriovenous graft (avg) * contraindications to angioplasty * immature avf

Keywords: angioplasty autologous artriovenous fistula dialysis ultrasound stenosis stenosis type characterization
sequential and personalized pk-guided busulfan administration in the frame of the conditiong regimen for allo-hsct in patients with malignant hemopathies ineligible for the standard myeloablative conditioning

Conditions: Acute Leukemia; Mielodysplasic Syndrome; Myeloproliferative Neoplasm

Summary: because the anti-leukemic activity of busulfan, this dug is largely used in graft conditioning but in elderly and/or cormobid patienth an excess of toxicity is observed. this study focus on the possibility of significanty reducing this toxicity by customizing the doses of busulfan to individual pk parameters.


Eligibility criteria:
inclusion criteria: * adult patient up to 65 years old * acute leukemia, myelodysplastic syndrome or myeloproliferative neoplasia eligible for an allogeneic transplant * chemosensitive disease, in complete or partial or stable remission * allograft from an identical hla related donor, haplo-identical or unrelated (hla compatibility from 8/10 to 10/10 according to hla-a, -b, -c, -dr, -dq allelics) * signed consent to participate -. affiliation to a social security regimen or beneficiary of this regimen * patient not eligible for standard myeloablative conditioning due to age\> = 45 years and / or the presence of an hct-ci comorbidity score\> = 3 exclusion criteria: * pregnant woman, without effective contraception or breastfeeding * person in emergency situation, patient deprived of liberty or placed under the authority of a tutor, * impossibility of undergoing medical follow-up of the trial for geographic, social or psychological reasons * contraindications to performing an allogeneic transplant * previous allograft * placental blood allograft
nw roselle in grade 1 essential hypertension: phase iii clinical trial

Conditions: Essential Hypertension

Summary: in this phase iii clinical trial, researchers evaluate the efficacy and safety of nw roselle®, a powdered medicinal product developed by natural wellness. nw roselle combines extracts from hibiscus sabdariffa (hs) flowers and olea europaea (oe) leaves. the trial aims to gather evidence on the efficacy and safety of nw roselle as a potential treatment option for grade 1 essential hypertension.

hypertension is a major risk factor for heart, brain, and kidney diseases, and is a leading cause of death and illness globally. natural wellness has developed nw roselle®, a powdered medicinal product that combines extracts from hibiscus sabdariffa (hs) flowers and olea europaea (oe) leaves. in this phase iii clinical trial, researchers are evaluating the efficacy and safety of nw roselle, in the treatment of grade 1 essential hypertension. eligible participants who meet the criteria will be enrolled and randomized in a 1:1 ratio. they will be assigned to receive either nw roselle or an active control, captopril 25 mg twice daily. before the treatment begins, participants will provide informed consent and undergo assessments to collect information about their medical history, hypertension status, lifestyle factors, and demographics. throughout the trial, the participant's vital signs, physical exams, and laboratory tests will be conducted to monitor their health and response to the treatment. adherence to the assigned treatment will be monitored, and any potential adverse events or side effects will be tracked.

Eligibility criteria:
inclusion criteria: 1. diagnosed with grade 1 essential hypertension (systolic blood pressure: 140-159 mmhg, and/or diastolic blood pressure 90-99 mmhg) (williams et al., 2018). 2. not currently taking any medication for hypertension. 3. able and willing to provide written informed consent. exclusion criteria: 1. pregnant or lactating women. 2. patients with bmi \> 45 kg/m2 or bmi \< 18 kg/m2. 3. patients with a known history of secondary hypertension (e.g., hyperaldosteronism, pheochromocytoma, renal artery stenosis, cushing syndrome). 4. renal impairment (estimated creatinine clearance (cr.cl.) \< 30 ml/min as measured by the cockcroft-gault formula). 5. known severe hepatic impairment, biliary cirrhosis, or cholestasis. 6. patients with a history of arrhythmias, ischemic heart diseases, obstruction of the outflow tract of the left ventricle (e.g., hypertrophic obstructive cardiomyopathy, and high-grade aortic stenosis), congestive heart failure, valvular disease, myocardial infarction (mi), angina, myocardial revascularization, or cerebrovascular accident (cva) within 6 months prior to study entry. 7. participation in other clinical studies within 30 days before screening. 8. known or suspected allergy or any contraindications to the trial products.

Keywords: grade 1 hypertension primary hypertension hibiscus olive leaves medicinal plants blood pressure
chronic obstructive pulmonary disease (copd) nutrition support trial

Conditions: Malnutrition

Summary: the purpose of this study is to determine the best form of dietary intervention to undernourished individuals with copd. the research aims to test the null hypothesis that there is no difference between oral nutritional supplements and dietary advice.


Eligibility criteria:
inclusion criteria: * male or female * age \>18 years * at risk of malnutrition * competent to provide written informed consent and able to answer questions * able to eat and drink * willingness to take part in the trial and to follow the trial protocol * fev1 \<80% predicted and fev1/fvc \<0.7 exclusion criteria: * requirement for tube or parenteral nutrition * galactosemia * receiving current oral nutritional supplementation * palliative care * chronic renal disease requiring dialysis * liver failure * malignancy * participation in other studies * bronchiectasis * those already under the care of a dietitian

Keywords: nutrition copd
l. acidophilus (strain tw01) on gut health, body composition, and inflammation

Conditions: Overweight (BMI &gt; 25); Obese, Otherwise Healthy Volunteers

Summary: this is a pilot research study to investigate the effects of a probiotic supplement (l. acidophilus, strain tw01) on substances found in the stool and bloodstream, gut bacteria composition, body composition, as well as any relationship of these substances with markers of inflammation. lactobacillus acidophilus is commonly found in a variety of fermented foods, including yogurt, cheese, and kefir, due to its ability to produce lactic acid and other substances. this bacterium is generally well-tolerated in healthy individuals and has a longstanding history of safe use. the investigators are doing this pilot study to see if a particular probiotic, called l. acidophilus (strain tw01) and isolated from fermented coffee grounds, can make a positive difference in human gut and overall health. specifically, the investigators want to look at how this probiotic affects certain substances in human stool and blood, the makeup of the bacteria in the gut, and aspects of body composition. the investigators are also interested in whether these changes relate to markers of inflammation, which can tell us more about their impact on overall health. this probiotic strain has been shown in other studies to be safe and well tolerated, and the investigators hope our research will help us better understand how it works and whether it might support health in humans.


Eligibility criteria:
inclusion criteria: 1. age 18-60 years 2. body mass index (bmi) between 28 kg/m2 and 40 kg/m2 3. waist circumference ≥ 88 cm or 35 inches for women, ≥ 102 cm or 40 inches for men 4. willing to consume experimental capsules daily 5. willing to prepare and consume the delivered meal kits 6. do not fit any exclusion criteria exclusion criteria: 1. self-reported history of immunodeficiency, major gastrointestinal surgery, renal or liver disease, diabetes, heart disease, stroke, peripheral artery/vascular disease, cancer, eating disorders, gut-associated pathologies, autoimmune diseases, pacemaker, thyroid disease, gallbladder disease, chronic inflammatory diseases, scleroderma, blood clotting disorders, intravenous drug use 2. weight changes \> 10% over the last 4 weeks 3. oral antibiotics and/or probiotics use up to 1 month prior to study and during study 4. currently taking glp-1 analogues (e.g., ozempic), anti-inflammatory medications (e.g., corticosteroids), daily use of nonsteroidal anti-inflammatory drugs (nsaids) (occasional use is permitted), medications which primarily affect blood clotting (e.g., warfarin), or any medications that suppress the immune system. 5. dairy allergy 6. currently pregnant or breast-feeding

Keywords: obesity probiotics gut health
egfr monoclonal antibody for advanced gastric cancer

Conditions: Gastric Cancer; Cetuximab; Nimotuzumab

Summary: this study is intended to evaluate efficacy and safety of egfr monoclonal antibody (cetuximab/nimotuzumab) in combination with a chemotherapy in gastric cancer patients with egfr amplification.

this parallel, randomized, open-label, single-centre study will evaluate the effect on overall survival of egfr monoclonal antibody (cetuximab/nimotuzumab) in combination with a chemotherapy compared to the chemotherapy alone in patients with egfr-amplication advanced gastric cancer. cetuximab will be administered as intravenous infusion of 500 mg/m2 (bsa) every 3 weeks, while nimotuzumab will be administered as intravenous infusion of 400mg every week. the chemotherapy consists of a combination of 12 cycles of mfolfox-6, 6-8 cycles of sox, 6-8 cycles of capox. treatment with cetuximab/nimotuzumab will continue until disease progression. the target sample size is 50-100 patients.

Eligibility criteria:
inclusion criteria: * adult patients \>=18 years of age * inoperable locally advanced, recurrent, and/or metastatic cancer of the stomach or gastro-esophageal junction adenocarcinoma * egfr-amplification tumors (copy number\>=5 for tissue or blood next generation sequence) * expected survival ≥ 3 month; * ecog / ps score: 0-2; * the main organ function to meet the following criteria: hb ≥ 90g / l, anc ≥ 1.5 × 109 / l, plt ≥ 80 × 109 / l,bil \<1.5 times the upper limit of normal (uln); liver alt and ast \<2.5 × uln and if liver metastases, alt and ast \<5 × uln; serum cr ≤ 1 × uln, endogenous creatinine clearance ≥50ml/min; exclusion criteria: * previous chemotherapy for advanced/metastatic disease; * lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome; * history of cardiac disease; * dyspnoea at rest, due to complications of advanced malignancy or other disease, or patients who require supportive oxygen therapy; * patient can not comply with research program requirements or follow-up;
seizure prophylaxis in aneurysm repair

Conditions: Intracranial Aneurysms; Seizures

Summary: seizures are a potential complication of surgical repair of intracranial aneurysms. in order to prevent seizures, many surgeons administer prophylactic anti-epileptic medication during the intra-operative and post-operative period, however, such practice is not supported by clinical data. retrospective review found the incidence of postoperative seizures was higher in those who received anti-epileptics versus those who did not. the goal is to examine the utility of levetiracetam (keppra) for seizure prophylaxis in patients undergoing surgical repair of unruptured intracranial aneurysms.


Eligibility criteria:
inclusion criteria: 1. adult (≥18 years) 2. presence of intracranial aneurysm (without rupture) 3. treating surgeon has recommended surgical repair of the aneurysm. exclusion criteria: 1. history of seizures within last 10 years 2. history of epilepsy 3. history of prior stroke 4. currently prescribed medication with anti-epileptic activity (keppra,dilantin, tegretol, lamictal, topamax, etc.) 5. brain tumor 6. pregnant or nursing woman 7. known levetiracetam allergy
the effectiveness of portable electronic vision enhancement systems (p-eves) for near vision in visual impairment

Conditions: Moderate or Severe Vision Impairment, Both Eyes

Summary: over 1 million people in the uk suffer from untreatable visual impairment, many of them elderly. the major complaint of visually impaired people is their inability to carry out simple tasks, especially those involving reading. it is known that this activity limitation is a major cause of depression in an older population, and it is reflected in reduced quality of life. low vision clinics, mostly based within hospital ophthalmology departments, dispense optical magnifiers to allow patients to carry out these tasks again, but these devices do have limitations (unusual posture, short working distance, monocular viewing). although electronic magnifiers have been around since the 1960s, they were initially very large and expensive. recent advances in technology have brought about an explosion in the number and range of portable and moderately-priced aids, which can be used binocularly, in a natural working position: these are currently not available through the nhs. evidence is needed as to whether these portable hand-held electronic magnifiers could offer a significant benefit to the majority of patients, and therefore whether they should be routinely dispensed in low vision clinics. the proposed study is a two-arm randomised crossover trial with existing users of optical magnifiers being assigned to use a hand-held electronic magnifier in addition to their existing devices for 2 months. reading and task performance will be measured with the aid, and compared to the performance with optical aids, and the patient will be asked to report on the comparisons between the aids.


Eligibility criteria:
inclusion criteria: * patients of manchester royal eye hospital * visual impairment secondary to range of stable ocular pathologies (no change in va \> 2 lines in previous 6 months) * currently possess a near vision optical magnifying device. * va \<= 6/30 (\<=0.7 logmar) and/or log contrast sensitivity \<=1.20 exclusion criteria: * current use of personal eves device * hearing inadequate to respond to verbal instruction * habitual language not english * a physical disability preventing the participant from operating the device * a score of less than 19 on the mini-mental state examination

Keywords: portable electronic magnifiers
comparison of 2 extracts of saw palmetto versus placebo on lower urinary tract symptoms (luts) and urinary frequency

Conditions: Lower Urinary Tract Symptoms

Summary: a randomized, double-blind, placebo-controlled, parallel group study to compare 2 extracts of saw palmetto versus placebo on lower urinary tract symptoms and urinary frequency in 120 generally healthy participants, 45 - 80 years.


Eligibility criteria:
inclusion criteria: * male aged between 45-80 * mild to moderate in the ipss * generally healthy * able to provide informed consent * agree not to participate in another clinical trial while enrolled in this trial * agree not the change their diet or exercise while enrolled in this trial exclusion criteria: * serious illness e.g., mood disorders such as depression, anxiety or bipolar disorder, neurological disorders such as ms, kidney disease, liver disease or heart conditions (a serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments) * unstable illness e.g., diabetes and thyroid gland dysfunction (an unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity) * have used a drug/natural therapy for luts or other urological symptoms within the last 30 days? * have had a urinary infection in the last 30 days or have, chronic urinary tract infections, or diagnosed chronic prostatitis * have had urogenital surgery within the last 6 months. * have had a bladder biopsy and/or cystoscopy and biopsy within the past 30 days. * have been diagnosed with chronic persistent local pathology (e.g. interstitial cystitis, bladder stones) * receiving/ prescribed coumadin (warfarin) or other anticoagulation therapy * diagnosed genital anatomical deformities, uncontrolled diabetes mellitus, and history of spinal cord injury, uncontrolled psychiatric disorder, and/or abnormal secondary sexual characteristics. * diagnosed cancer including prostatic cancer; if suspected by the investigator, refer for medical assessment * active smokers and/or nicotine or drug abuse * chronic alcohol use (\>14 alcoholic drinks week) * allergic to any of the ingredients in investigational, comparator or placebo formula * any condition which in the opinion of the investigator makes the participant unsuitable for inclusion * participated in any other clinical trial during the past 1 month