Kornimate/medical-research-clean huggingface dataset:
the extended salford lung study ("ex-sls") data access project

Conditions: Asthma

Summary: the salford lung study (sls) subjects represent a group of copd and asthma patients whose disease is extremely well-characterised over a short time period. subjects in the sls originally consented for information relevant to the study to be shared with the sponsor (gsk). these data were limited to three years prior to randomisation and the twelve-month interventional treatment period. broadened access to patients' data would allow sls subjects' entire disease journey to be researched, presenting a rare opportunity to improve scientific and clinical understanding of copd/asthma disease risk, treatment and progression. this proposal seeks to collect additional subject-level data from sls patients via their electronic medical records (encompassing past and future data for up to 10 years from the date of consent) and via a one-off patient questionnaire administered at the time of consent.


Eligibility criteria:
inclusion criteria: * subjects who were randomized to treatment in the original sls studies * subjects who are able to, and choose to, provide written consent for the additional information to be collected. exclusion criteria: * subjects who were lost to follow-up/moved away, withdrew consent or died during or subsequent to the original sls studies. * subjects considered (at the discretion of the investigator) as too ill to participate or without the mental capacity to provide informed consent.

Keywords: asthma chronic obstructive pulmonary disease salford lung study
foot perfusion analysis to predict limb salvage

Conditions: Critical Limb Ischemia; Peripheral Arterial Disease

Summary: this study aims at evaluating the correlation between foot perfusion on angiographies performed before and after revascularization and limb salvage in patients with critical limb ischemia.

critical limb ischemia (cli) in diabetic patients is increasing drastically worldwide, and is already recognized as a major health issue. cli is frequently leading to major amputations. therefore, one of the key point to prevent limb loss is to restore a good vascularization to the foot, usually thanks to endovascular means. no consensual indicator is currently available to estimate if the limb revascularization will be sufficient or not to prevent amputation, and to help physicians decide if they should be more aggressive during the endovascular procedure. transcutaneous oximetry and value of the ankle-brachial index (abi) are commonly used in the ward (not available in the operating room), but have shown poor correlation to wound healing or limb salvage and results are frequently biased because of the arterial wall calcifications due to diabetes. value of the first toe systolic pressure is currently under evaluation to predict survival without amputation, with promising results, but cannot be applied to patients with wounds at this level or previous minor amputation. the emergence of hybrid rooms in the operating theater offer access to high quality imaging and image post-treatment. those capabilities could be used to analyze the flow and the tissue perfusion in the foot, and correlate those imaging parameters to positive clinical outcomes, such as wound healing, thus creating a useful tool to guide physicians in daily practice. differences between foot angiographies performed before and after revascularization could be used to estimate the quality of the revascularization and predict wound healing and limb salvage. this method would be directly available in the operating room and could help physicians to optimize their strategy during the procedure

Eligibility criteria:
inclusion criteria: * patients with critical limb ischemia rutherford 4, 5 and 6, with at least one pre-operative exam (cta, magnetic resonance angiography or ultrasound) demonstrating a peripheral arterial disease, and requiring an endovascular or hybrid (meaning combined with a surgical technique) revascularization of the lower limb. exclusion criteria: * patients not willing to give their consent to study enrollment * patients under 18 years old * patients with severe renal insufficiency (estimated creatinine clearance \< 30 ml/min), without dialysis * patients with life threatening septic wounds who would require an amputation at the initial presentation

Keywords: limb salvage foot perfusion hybrid room
clinical effectiveness of high frequency chest wall oscillation (hfcwo) in a bronchiectasis population

Conditions: Bronchiectasis

Summary: the primary objective is to compare the patient's baseline qol prior to hfcwo use against the patient's qol at various study timepoints over a one-year period of hfcwo use.

this study will use a prospective interventional comparative study design using the patient's quality of life (qol) as the primary study endpoint to determine hfcwo affect. the study will compare the patient's qol baseline (established at enrollment prior to hfcwo treatment) to the qol measured at various timepoints (enrollment, 2 months, 6 months and 12 months) over a one-year period whilst receiving hfcwo treatment. in addition, a baseline for the secondary endpoints will established at enrollment for comparison to measurements taken at various timepoints over a one-year period whilst receiving hfcwo treatment. the patient's medical records will be used to establish prior histories of exacerbation rates for comparison to exacerbation rates experienced after one year of hfcwo treatment. patients will serve as their own control.

Eligibility criteria:
inclusion criteria: 1. 18 years of age or older 2. previous diagnosis of bronchiectasis confirmed by hrct within the last 6 months 3. patients must have at least 6 months of medical records related to bronchiectasis 4. patients must be stable and currently on a standard of care regimen for bronchiectasis such as hypertonic saline and/or pep 5. patients with 1 or more exacerbations within the last 12 months 6. previous and existing productive cough 7. no previous hfcwo use exclusion criteria: 1. patients who are known to have cystic fibrosis 2. patients who are known to have primary ciliary dyskinesia (pcd) 3. patients with chronic obstructive pulmonary disease (copd) without bronchiectasis 4. patients breathing via an artificial airway 5. severe bronchospasm based on exam or history 6. any comorbidity(ies) or contraindications that would normally complicate tolerating hfcwo treatment

Keywords: hfcwo bronchiectasis smartvest
assessment of serum leptin in vitiligo patients

Conditions: Vitiligo

Summary: evaluation of serum leptin in vitiligo patients and control assessing its correlation to the body mass index and disease dermographic data .

, leptin is supposed to contribute to vitiligo pathogenesis through promoting the release of pro-inflammatory mediators such as tumor necrosis factor α "tnf," il-2 and il-6, as well as enhancing cytotoxic t cells "cd8" recruitment and inhibiting the functions of regulatory t cells "tregs". leptin can also aid in induction of oxidative stress by activating nicotinamide adenine dinucleotide phosphate (nadph) oxidase• venous blood samples will be taken from patients and controls to evaluate serum leptin: morning samples will be taken after 12-h overnight fast in plain vacutainer tubes and directly centrifuged (1098 g for 15 min). * sera will be then collected in plain, capped, 5 ml centrifuge tubes "eppendorf" and freezed at -20ᵒc in a well-monitored freezer until the analysis is performed• serum leptin will be quantitatively assessed in vitro using drg leptin sandwich enzyme linked immuno-sorbent assay "elisa". * elisa will be performed according to manufacturer's guidelines where each run included a standard curve. * using the mean absorbance value for each sample, the corresponding concentration from the standard curve will be determined.

Eligibility criteria:
inclusion criteria: * all patients with vitiligo who are above the age of 18 years exclusion criteria: * patients with other autoimmune diseases
ethnic differences in the inflammatory response in systemic inflammation

Conditions: Endotoxemia

Summary: the purpose of this study is to investigate putative ethnic differences in the proinflammatory response in human endotoxemia.

recent data show that there are significant disparities among genders and races in the incidence of sepsis. while men are consistently more likely to have sepsis than women, the apparent racial disparities are even more striking, approaching a doubling of the risk for sepsis among afro-americans. most prominent is the risk among black men, the group in which sepsis occurs at the youngest age and results in the most deaths. potential mechanisms for heterogeneous susceptibility to sepsis include genetic differences, which have been explored according to sex but not according to race, and other social and clinical factors. the goal of this study is to explore whether proinflammatory and procoagulant responses in a well standardised inflammation model are comparable in healthy caucasian and african volunteers.

Eligibility criteria:
inclusion criteria: * signed informed consent obtained before any trial-related activities. (trial activities are any procedure that would not have been performed during normal management of the subject). * men aged \>18 and \<40 years * normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant * normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant exclusion criteria: * treatment with an investigational drug within three weeks prior to this trial * participation in an lps trial within the last 6 weeks * hereditary deficiency of protein c or s, or a mutation of fv (leiden), or any other known abnormality affecting coagulation, fibrinolysis or platelet function * history of cardiovascular disease * liver or kidney dysfunction * regular use of medication or alcohol abuse * use of any medication within three weeks prior to the first trial day * symptoms of a clinically relevant illness in the 3 weeks before the first trial day * excessive sporting activities * weight over 95 kg

Keywords: lps ethnicity neutrophils tnf
detecting dementia in the retina using optical coherence tomography

Conditions: Dementia Alzheimers; Dementia; Dementia, Vascular; Dementia Senile

Summary: this retrospective case control explores the retinal features of dementia associated with neurodegenerative diseases, particularly alzheimer's disease. by linking a pseudonymised dataset of three-dimensional retinal scans, called optical coherence tomography, with nationally held data on dementia, corresponding characteristics will be evaluated through descriptive statistics and machine learning techniques.

by 2025, it is estimated that approximately 1 million people in the united kingdom (uk) will suffer from dementia, a syndrome associated with progressive decline in brain function. while there is currently no cure for most types of dementia, early diagnosis can help patients receive the appropriate treatment and support to help maintain mental function. the focus of this project is to identify changes in retinal structure associated with dementia. in collaboration with bioinformatics experts at university college london (ucl), the investigators propose to analyse our repository of \>1 million retinal scans, termed optical coherence tomography (oct), performed regularly on patients since 2008. oct scans will be linked at a patient level to data from the hospital episode statistics (hes) database to identify those who have been diagnosed with dementia or went on the develop dementia. thus, a pseudonymised classified dataset of retinal scans will be generated for qualitative and quantitative analysis. the primary objective is to characterise changes in the layers of the retina associated with dementia. machine learning techniques may also be employed to identify novel patterns of retinal change associated with dementia.

Eligibility criteria:
inclusion criteria: all patients over the age of 40 who have undergone an optical coherence tomography scan at moorfields eye hospital nhs foundation trust exclusion criteria: poor quality image
effect of meal number, frequency, and form on satiety and metabolism after weight loss surgery

Conditions: Gastric Bypass Surgery; Obesity

Summary: analyze the effect of meal pattern (meal number, frequency, and form) on satiety, gut peptides, insulin, and glucose levels in individuals before and 12-15 months after gastric bypass surgery (gbp).

the main goal is to study the effect of meal number, size and texture on metabolism and incretin levels after gbp. patients will be studied before gbp (t0) and 12-15 months after gbp (t1). at t0 and t1, patients will come for 2 study days for 8 hours: on one study day, a single meal will be served, on the second study day, three small isocaloric meals, with the order of the conditions randomly assigned. the total amount of calories and the overall nutrient composition will be equivalent between conditions. the meals will be either all solid or all liquid. patients enrolled in the study will be randomly assigned to solid or liquid test meals. gastric emptying will be measured by the acetaminophen test.

Eligibility criteria:
inclusion criteria: * severely obese patients undergoing gastric bypass surgery (gbp)

Keywords: bariatric gastric bypass gastric banding, incretins glucagon-like peptide-1(glp-1) gastric inhibitory peptide (gip)
a clinical trial to evaluate the safety and efficacy of dr-2041(synthetic conjugated estrogens, a) for treatment of vulvovaginal atrophy

Conditions: Menopause

Summary: this is a four-arm, randomized, double-blind, parallel group, placebo-controlled study to compare the effects of two doses of dr-2041(synthetic conjugated estrogens, a) vaginal cream on vulvovaginal atrophy in postmenopausal women with or without a hysterectomy and/or oophorectomy.

the study will include a screening period up to 4 weeks and a 12- week treatment period. the overall study duration for participants will be approximately 16 weeks. study participants will undergo physical and gynecological exams, and blood tests for clinical laboratory assessments. all patients with a uterus will undergo transvaginal ultrasound.

Eligibility criteria:
inclusion criteria: * naturally or surgically menopausal * moderate or severe symptoms of vaginal atrophy (ie, dryness, itching, pain, uncomfortable intercourse) exclusion criteria: * known sensitivity or contraindication to estrogens or progestins * history or current diagnosis endometrial hyperplasia * recent history of vaginal bleeding of unknown cause * recent history or diagnosis of endometriosis * any contraindication to estrogen therapy

Keywords: vaginal atrophy vaginal dryness vaginal itching vaginal pain
impact of bedtime snacks on glucose control in type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: approximately 3 million canadians have type 2 diabetes, a condition where the blood sugar levels are too high, uncontrolled blood sugars lead to cardiovascular disease and other complications. patients with type 2 diabetes are often advised to consume a snack before bed in order to help control morning blood sugar levels. however, scientific evidence for this dietary approach is limited and there is no data to help elucidate what the ideal bedtime snack is. we hypothesize that a high protein, high fat snack with very little carbohydrate, will be an effective bedtime snack for lowering morning glucose without spiking glucose levels in the night. in this study we will determine if a bedtime snack that is high in protein and fat but low in carbohydrate can help improve morning glucose control in people with type 2 diabetes. this information will provide scientific evidence for the potential health benefits of strategically-timed high protein, high fat snack consumption in people with type 2 diabetes.

fifteen patients with physician diagnosed type 2 diabetes (hba1c 6.5-9%), between the ages of 30-80 years, and not on exogenous insulin therapy, will complete three, 3-day intervention periods (proof-of-concept randomized trial). participants will consume a standardized diet for three days with either i) two hard-boiled eggs, ii) fruit yogurt; or iii) control no-bedtime snack, thirty minutes prior to bedtime. fasting blood samples will be obtained on day 4 in the morning after following each 3-day dietary intervention. blood glucose will be monitored continuously across the intervention period using continuous glucose monitoring (cgm). cgm allows for the moment-to-moment changes in blood glucose to be examined for several days, allowing the unique opportunity to examine the glucose responses at different points of the day, including fasting hyperglycemia in the morning, nocturnal glucose, and postprandial glucose in response to meals. to our knowledge, cgm technology has never been used in a bedtime snacking study in type 2 diabetes.

Eligibility criteria:
inclusion criteria: * diagnosed type 2 diabetes * hba1c between 6.5 - 9.0% * no dietary restraints (lactose intolerance, dislike eggs, celiac disease) exclusion criteria: * heart attack or stroke within last year * exogenous insulin
clinical efficacy of fosfomycin trometamol per os in the treatment of documented male urinary tract infections with esbl-producing enterobacteriaceae with esbl producing enterobacteriaceae and resistance associated with fluoroquinolones and cotrimoxazole (fosf'hom)

Conditions: Urinary Tract Infections

Summary: the aim of the study was to evaluate the clinical and microbiological efficacy of fosfomycin trometamol (ft) per os in the treatment of documented male urinary tract infections with esbl-producing enterobacteriaceae


Eligibility criteria:
inclusion criteria: * clinical suspicion of urinary tract infection (uti) defined by the presence of at least one of these signs: fever \> 38°c and/or sus-pubic pain and/or dysuria and/or pollakiuria and/or urinary burns and/or macroscopic hematuria and/or acute urinary retention and/or pain with the rectal examination and/or confusion * and urinary analysis with leukocyturia \> 10 / mm3, bacteriuria \> 10\^3 cfu/ml with esbl producing enterobacteriaceae and resistance associated with fluoroquinolones (fq) and cotrimoxazole (ctx) but sensitive to fosfomycin. exclusion criteria: * allergy to fosfomycin and/or trometamol * presence of material in the urinary tract * severe immunosuppression * chronic prostatitis * prostate abscess * acute pyelonephritis * hemodynamic instability * chronic renal failure (clearance \<60 ml/min) * prior antibiotic therapy, with an antibiotic sensitive on the antibiotic susceptibility test except: amoxicillin - clavulanic acid, cefixime, nitrofurantoin. * co-treatment with metoclopramide
comparative effectiveness feasibility trial for insomnia among breast cancer survivors

Conditions: Breast Cancer Female; Insomnia

Summary: women with breast cancer who report insomnia that started or worsened during breast cancer diagnosis and treatment will be enrolled in a group behavioral trial to one of two arms testing cognitive behavioral therapy for insomnia against a mindfulness-based therapy.

the investigators are recruiting breast cancer survivors with stage i-iii or eastern cooperative oncology group 0-1 breast cancer to enroll in a group-delivered behavioral trial for insomnia. the investigators are comparing mindfulness-based therapies delivered in an alternative medicine context to cognitive behavioral therapy for insomnia. the intervention is 9 weeks, for two hours weekly.

Eligibility criteria:
inclusion criteria: * american joint committee on cancer (ajcc) stage i-iii or eastern cooperative oncology group (ecog) 0-1 breast cancer * completed active treatment (surgery, radiation, chemotherapy) at least three months prior * within 5 years of treatment or still on adjuvant therapy * completes informed consent to participate exclusion criteria: * sleep apnea or restless leg syndrome * practicing mindfulness techniques \>1/wk
arterial imaging of inflammation and resolution after endovascular surgery

Conditions: Peripheral Arterial Disease; Claudication, Intermittent; Claudication; PAD; SFA - Superficial Femoral Artery Stenosis; Iliac Artery Disease; Vascular Calcification

Summary: this study evaluates the local inflammatory and resolution response of patients undergoing peripheral vascular intervention like an angioplasty of the superficial femoral artery (sfa) or popliteal artery, or stenting of the iliac artery or sfa, through the use of positron emission tomography-magnetic resonance imaging (pet/mri). pet/mri will be performed prior to intervention, one day and one week after intervention.

magnetic resonance imaging (mri) imaging allows for non-invasive visualization of anatomical structures while positron emission tomography (pet) scans allow for the observation of molecular and cellular activities. using a pet/mri in patients with vascular injury post intervention with help evaluate the vascular inflammatory and resolution response in vivo. acute vascular injury through endovascular intervention results in recruitment of inflammatory cells such as macrophages to the vessel wall. macrophages are very metabolically active and consume glucose at a high rate. in pet/mri, subjects are injected with 18f-fluorodeoxyglucose (18f-fdg), a radioactively labeled glucose molecule which is consumed by macrophages. when 18f-fdg is consumed, it is retained within macrophages more avidly than other atherosclerotic lesion elements. thus, fdg-pet provides a unique and noninvasive approach to quantitatively measure macrophage activity at the intervention site. this study will provide key pilot data for developing an imaging surrogate endpoint for pro-resolving mediator treatment intervention trials going forward.

Eligibility criteria:
inclusion criteria: * over the age of 40, * with resting or exercise abi \<0.9, tbi \<0.6 * have claudication or limb threatening ischemia \& planning to undergo a percutaneous angioplasty of sfa or popliteal artery, or stenting of the iliac artery or sfa. exclusion criteria: * evidence of active infection * hypersensitivity or allergy to contrast agents * chronic liver disease, renal disease (gfr\< 30) or chronic inflammatory disorders * insulin dependent diabetes * presence of metal within subject's body, pacemakers, or defibrillators * bmi \ 35 * recent other major surgery or illness within 30 days * use of immunosuppressive medications or steroids * history of organ transplantation * pregnancy, or plans to become pregnant, or lactating

Keywords: peripheral arterial disease pad claudication, intermittent claudication sfa occlusion arterial occlusion iliac artery occlusion vascular calcification