Kornimate/medical-research-clean huggingface dataset:
pedal cycle related trauma at the royal london hospital

Conditions: Bicycle Accident

Summary: bespoke is an observational, prospective, cohort study. the aim of this study is to explore injury patterns of patients who require admission to the royal london hospital (rlh) emergency department (ed)or outpatient clinics as a result of any collision involving a bicycle. secondary objectives are to determine the circumstances around cycling injury and to explore the effect of cycling collisions on the return to work, activities of daily living and cycling. all patients that attend the emergency department of the royal london hospital following an injury sustained while cycling, will be invited to take part in the study. participants will be asked to answer a questionnaire about their cycling routines as well as provide information about the location, conditions and events surrounding their collision. patients' recovery will be followed by the study team using the electronic health record and by reviewing the patients' notes. morbidity and mortality data will be completed at death, discharge or 28 days from admission (whichever comes first). the patients will be followed up in person, email, or via telephone at 6 weeks following their initial admission. the research team hosted a patient and public involvement (ppi) event, to determine which outcome measures were important for the public to investigate. it was found that the majority of the group felt it was important to follow up return to work, return to cycling and return to activities of daily living in any patients who have had a cycling collision. these outcomes will be measured at the 6 week follow up.


Eligibility criteria:
inclusion criteria: * all patients who are 16 years and older attending the royal london hospital emergency department who have been injured while riding a bicycle (pedal cycle) * all patients who are 16 years and older who are transferred to the royal london hospital, either for inpatient or outpatient care, who were injured whilst riding a bicycle exclusion criteria: * patients who have been injured while involved in activities other than cycling * patients that decline to take part in the study * patients who are 15 years or younger * off road cyclists * motorbike riders
primary hyperaldosteronism and ischemia-reperfusion injury

Conditions: Primary Hyperaldosteronism

Summary: patients with primary hyperaldosteronism experience more cardiovascular events compared to patients with primary hypertension, independent of the blood pressure level. in this research we hypothesize that patients with primary hyperaldosteronism are more susceptible to ischemia-reperfusion injury.

patients with pha have an increased risk of cardiovascular events, independent of blood pressure level. also in patients suffering a myocardial infarction, circulating aldosterone levels are associated with increased mortality. in animal models of myocardial infarction, the administration of exogenous aldosterone increased infarct size, although other studies did not report this effect. in similar models, antagonists of the mineralocorticoid receptor (mr) reduced infarct size, which was completely abolished in ecto-5'-nucleotidase (cd73, the enzyme that catalyses extracellular formation of the endogenous nucleoside adenosine) and adenosine receptor knock-out mice. therefore, we hypothesize that patients with pha have an increased susceptibility for ischemia-reperfusion (ir)-injury due to down-regulation of the enzyme cd73. we will use the reduction in brachial flow-mediated dilation (fmd) by forearm ir as a well-validated endpoint for (endothelial) ir-injury.

Eligibility criteria:
inclusion criteria patients with primary hyperaldosteronism: * age 18-75 years * confirmed primary hyperaldosteronism (aldosterone \>0.28 nmol/l after salt loading) * serum potassium ≥ 3.5 mmol/l (with or without potassium supplementation) * written informed consent inclusion criteria patients with primary hypertension: * age 18-75 years * primary hypertension * baseline aldosterone \<0.30 nmol/l and aldosterone-renin-ratio\<0.09 * serum potassium ≥ 3.5 mmol/l * written informed consent exclusion criteria for both arms (patients with primary hyperaldosteronism and patients with primary hypertension: * smoking * history of atherosclerotic disease (myocardial infarction (mi), stroke, or peripheral vascular disease) * not possible to change the antihypertensive medication into only diltiazem with or without hydralazine, according to the treating physician. * not possible to temporarily interrupt statin treatment, if the patient use statins, according to the treating physician. * severe renal dysfunction (mdrd \< 30 ml/min) * second/third degree av-block on electrocardiography * cardiac failure * diabetes mellitus * use of acetylsalicylic acid and nsaid's theophylline, and dipyridamole

Keywords: primary hyperaldosteronism primary hypertension forearm ischemia-reperfusion (reduction) in brachial artery fmd endothelial ischemia-reperfusion injury
care bundle and acute kidney injury progression

Conditions: Acute Kidney Injury

Summary: the goal of this clinical interventional study is to learn about the effect of implementing a care bundle in the progression of acute kidney injury (aki) in critical patients. the main questions it aims to answer are: * what is the impact of care bundle in aki progression? * some improvement of care bundle adhesion rate through an electronic alert can be achieved? participants will be adults and critical patients with aki. during observational study the incidence and progression of aki will be measured, as well spontaneous care bundle adhesion by medical team. in the interventional study, the progression rate of aki influenced by care bundle will be measured, as well the adhesion of care bundle through an electronic alert inserted in the patient's daily medical record.

this is a clinical, multicentric and prospective trial (study type: "before" and "after"). patients aged ≥18 years, admitted to clinical and surgical intensive care units (icus) will be included according to selection criteria. during observational and interventional studies clinical and laboratorial information from electronic medical records will be registered. aki diagnosis and classification will be based on serum creatinine levels according to kidney disease improving global outcomes (kdigo) criteria. the observational study will be carried out to measure the incidence of aki kdigo 1 and its progression rate, in order to estimate sample size for the interventional study. researchers assumed a 10% to 20% reduction in the progression of aki kdigo 1 to more advanced stages after the implementation of the care bundle. in the interventional study, the care bundle will be included in the medical records of each individual who develops aki kdigo 1. patients included in this study will be followed by 7 days from inclusion. adhesion rate to the care bundle will be measured between observational and interventional studies.

Eligibility criteria:
inclusion criteria: * patients with recent icu admission (≤ 48 hours) * patients without aki or with aki kdigo 1 at the time of admission exclusion criteria: * patients with chronic kidney disease, stage 4 to 5d * patients with kidney transplant * patients with aki kdigo 2, 3 or on dialysis at the time of inclusion in the study

Keywords: acute kidney injury care bundle critical patients
developmental trajectories in asd until adulthood: a 15 years follow-up study

Conditions: Autism Spectrum Disorders

Summary: epidemiological studies have shown that a wide range of outcome trajectories exist in asd, but little is known about their determinant in a long-term perspective. the epited cohort was set-up in order to understand the heterogeneity of developmental trajectories among children with a diagnosis of pdd and the role of clinical, biological and environmental factors in their adaptive outcome. it is one of the rare cohorts involving a long term prospective follow-up based on a large set of variables, and precise phenotypes of the entire autism spectrum.

purpose: epidemiological studies have shown that a wide range of outcome trajectories exist in asd, but little is known about their determinant in a long-term perspective. the epited cohort was set-up in order to understand the heterogeneity of developmental trajectories among children with a diagnosis of pdd and the role of clinical, biological and environmental factors in their adaptive outcome. it is one of the rare cohorts involving a long term prospective follow-up based on a large set of variables, and precise phenotypes of the entire autism spectrum. participants: this longitudinal study for which recruitment began between 1997 and 1999, has initially involved 281 preschool aged children recruited from 5 french areas. they were seen at 8 (time 2), 15 (time 3) and 20 years of age (time 4), with an average follow-up length of 15 years. at each follow-up, socio-demographical, clinical, developmental and interventional were collected. at time 4 (fourth visit), dna was collected to do a genetic study findings to date: the main results show that there were two developmental trajectories from childhood to adolescence among the cohort leading to very distinct level of adaptive functioning. prognosis factors in childhood were the intellectual level, the presence or absence of language, the autism degree and the absence or presence of epilepsy. during adolescence there was a negative impact on the quality of life of the parents of the presence of aberrant behavior and low level functioning, the children included in the cohort were followed during 15 years and were assessed four times (at 5, 8, 15 and 20 years on average, see flow chart in figure 1. from 2000 to 2002, 219 of the original group were reassessed (time 2, t2). at time 3 (t3), between 2007 and 2009, they were 152 to be re-assessed and 106 between 2012 and 2015 (time 4, t4).

Eligibility criteria:
inclusion criteria: * patients previously include in the troop constituted in 1997 /1999 as part of phrc 96/97 and having been followed during 10 years. * patients are 18 * patients with diagnosis of infantile autism or atypical autism according to the criteria of the cim 10 at the time of their initial inclusion. exclusion criteria: * refusal of participation * women pregnant breastfeeding * persons deprived of freedom by court order

Keywords: autism spectrum disorders cohort
a study of tadalafil in men with benign prostatic hyperplasia

Conditions: Benign Prostatic Hyperplasia (BPH)

Summary: the purpose of this study is to determine whether an experimental drug known as tadalafil given once daily can reduce the symptoms associated with benign prostatic hyperplasia (straining, urinary frequency, feeling like your bladder is still full etc.)


Eligibility criteria:
inclusion criteria: * men 45 years of age or older with benign prostatic hyperplasia (bph) also referred to as bph-lower urinary tract symptoms (luts) on the disease diagnostic criteria at the start of study. * provide signed informed consent at the start of the study. * agree not to use any other approved or experimental pharmacologic bph, overactive bladder (oab), or erectile dysfunction (ed) treatments anytime during the study. * have not taken finasteride therapy for at least 3 months before study drug is dispensed and dutasteride therapy for at least 6 months before study drug is dispensed. * have not taken other bph therapy (including herbal preparations), oab therapy, ed therapy for at least 4 weeks prior to study drug is dispensed. * have luts with a total international prostate symptom score (ipss) greater than or equal to 13 when study drug is dispensed. * have reduced urine flow (measured by special toilet equipment). * demonstrate compliance with study drug administration requirements. exclusion criteria: * treated with nitrates * have unstable angina or angina that requires treatment. * have had any of the following in the past 90 days: heart attack, also known as a myocardial infarction (mi); heart bypass surgery (called coronary artery bypass graft surgery); had a procedure to open up blood vessels in the heart known as angioplasty or stent placement (percutaneous coronary intervention). * have very high or very low blood pressure. * have certain neurological conditions associated with bladder problems or injuries to brain or spinal cord within a specified time of starting this study. * have uncontrolled diabetes. * have prostate cancer, are being treated for cancer. * have prostate specific antigen (psa) greater than 10 nanograms per milliliter (ng/ml) at the start of study.
trial comparing chlorambucil to fludarabine in patients with advanced waldenström macroglobulinemia

Conditions: Waldenström Macroglobulinemia; Lymphoplasmacytic Lymphoma; Splenic Marginal Zone Lymphoma

Summary: waldenström's macroglobulinaemia (wm) is a lymphoproliferative disorder characterized by a monoclonal igm paraprotein and morphological evidence of lymphoplasmacytic lymphoma: the cells are igm+, igd+, cd19+ and cd20+ but usually cd5-, cd10- and cd23-. the treatment efficacy is difficult to assess because of the lack of clear diagnostic criteria , good response criteria, and of randomized trials. the actual treatment is chlorambucil, an alkylating agent. a purine analogue such as fludarabine has proven its efficacy on 30 % to 80 % as first line therapy this study is a phase ii b open, prospective, international multicenter trial (england, dr johnson, dr catovsky, australia: dr seymour) promoted by the french cooperative group on chronic lymphoid leukemia in untreated wm, or closely related disorders ( lymphoplasmacytic lymphoma or splenic marginal zone lymphoma). 366 patients must be included, among them 180 patients in france. patients will be stratified according to the lymphoproliferative disorder. the patients will receive chlorambucil by oral route for 10 days every 28 days (12 cycles) (8 mg/m², 6 mg/m² if patient is more than 75 years old) or fludarabine by oral route for 5 days every 28 days (6 cycles) (40mg/m², 30 mg/m² if patient is more than 75 years old). the primary objective is to compare the efficacy (response rate) of chlorambucil to fludarabine in previously untreated patients. the secondary objectives are the duration of response, the improvement of hematological parameters, the toxicity, the quality of life, the event free survival and the overall survival.


Eligibility criteria:
inclusion criteria: established diagnosis of waldenström macroglobulinemia (the 2nd workshop on waldenstrom's macroglobulinemia) or lymphoplasmacytic lymphoma or splenic marginal zone lymphoma, needing a treatment * life expectancy \> 6 months * creatinine \< 200 µmol/l * sgpt and sgot \< 2x uln * a negative direct coombs test * written informed consent exclusion criteria: * past chemotherapy/radiotherapy/immunotherapy prior to the study for waldenström macroglobulinemia * previous malignancy less than 5 years ago except carcinoma in situ of the cervix and non-melanoma skin cancer * positive hiv serology * active hepatitis b or c * lactation/pregnancy * impossible good compliance with the study protocol * active infection not controlled * psychological condition hampering understanding of the study * transformation into large b cell lymphoma * peripheral neuropathy \> grade ii

Keywords: waldenström macroglobulinemia lymphoplasmacytic lymphoma splenic marginal zone lymphoma fludarabine chlorambucil
intrathecal diamorphine versus femoral nerve block in primary total knee arthroplasty

Conditions: Osteoarthritis

Summary: primary total knee arthroplasty (tka) is commonly associated with moderate to severe early post-operative pain. the primary aim of this study was to investigate the impact of either a single-shot femoral nerve block (fnb) or intrathecal diamorphine (id) on post-operative pain after tka the null hypothesis is that there is no difference in the post operative pain relief provided for tka by a single-shot femoral nerve block (fnb) as compared to intrathecal diamorphine (id).

in 2008, the prospect working group, a multidisciplinary expert panel, published their consensus guidelines on the relative merits of different anaesthetic and analgesic techniques for tka based on a review of the available published literature up to 2005. these guidelines supported the use of general anaesthesia combined with a femoral nerve block for surgery and postoperative analgesia, or alternatively spinal anaesthesia with local anaesthetic combined with spinal morphine. the preference for femoral nerve block in favour of intrathecal opiates was as a consequence of the greater potential for side effects with the latter technique. the authors conceded that there were a lack of well-conducted studies on this subject, graded their recommendations as level d (expert opinion), and concluded further research was needed. consequently there has been debate around the conclusions drawn and clinicians have not universally accepted the recommendations. most researchers to date have focused on short-term outcomes such as static pain scores and/or opiate consumption. it is also important however to investigate dynamic pain scores, patient reported outcomes, the attainment of rehabilitation goals, length of stay and longer term functional outcomes. in addition, the use of the total pain relief score (totpar) as described by cooper and beaver, assesses the cumulative response to treatment. this is a well validated area under the time-analgesic effect curve (auc) derivation for pain relief which is commonly used by meta-analyses of analgesic interventions. the aim of this study is to investigate all these endpoints in patients receiving a single-shot femoral nerve block (fnb) for tka as compared to intrathecal diamorphine (id), a more commonly used spinal opiate in united kingdom anaesthetic practice.

Eligibility criteria:
inclusion criteria: * adult patients scheduled for primary unilateral total knee arthroplasty exclusion criteria: * uni-compartmental surgery, bilateral surgery, contra-indication to spinal anaesthesia or peripheral nerve block (anticoagulation, hydrocephalus, raised intracranial pressure), allergy to local anaesthetics or diamorphine, malignant hyperthermia or other concerns over general anaesthesia, chronic opiate use and chronic pain medication use (e.g. gabapentin, pregabalin, amitriptyline).

Keywords: arthroplasty analgesia
momentum project heidelberg - dealing actively with a cancerous disease

Conditions: Colorectal Cancer; Breast Cancer; Prostate Cancer; Physicians; Nurses

Summary: the study, investigates the current physical activity promotion practices among physicians and nurses, as well as social norms toward physical activity during treatment among cancer patients and among physicians and nurses who treat or counsel cancer patients.

for this purpose, four large surveys with health care professionals (specialized practitioners, n=300; general practitioners, n=300; oncology nurses, n=300) and cancer patients (n=1200, 400 patients each with breast, prostate or colorectal cancer) with a cross-sectional research design are conducted. additionally, a follow-up-study with a sub-sample of cancer patients (n=180) will be conducted.

Eligibility criteria:
inclusion criteria: * hcp are eligible if they meet the following inclusion criteria: working as an oncological nurse, general practitioner or physician specialized in oncology, radiology, surgery, gynecology, urology, gastroenterology or rehabilitation signed informed consent * patients are eligible if they meet the following inclusion criteria: patients with a diagnosis of primary tumor or recurrence no longer than 2 years ago who are undergoing chemo- or radiotherapy currently or in the last 2 years patients undergoing chemo- or radiotherapy currently or no longer than 2 years ago at least 18 years of age sufficient german language skills signed informed consent exclusion criteria: * hcp will be excluded from the trial if they meet the following exclusion criteria: no regular contact with cancer patients * patients will be excluded from the trial if they meet the following exclusion criteria: presence of comorbidities that preclude involvement in exercise programs (e.g. severe pain, advanced heart failure \[≥ nyha iii\]) mentally retarded reduced standing ability and no ability to walk
incidence of brachial plexus injury after rotator cuff repair with continuous interscalene block

Conditions: Brachial Plexus Injury

Summary: brachial plexus injury after shoulder surgery with continuous interscalene block is 2.4% at 1 month and 0% at 6 months, but may be higher with a systematic postoperative neurological examination. indeed, femoral neuropathy after anterior cruciate ligament reconstruction is 24% at 6 weeks in a cohort of 20 consecutive patients systematically screened with an electromyogram. brachial plexus injury may be the consequence of the surgery (direct lesion by traction) or the continuous interscalene block. the goal of this study is to define the etiology of this postoperative neuropathy.

rotator cuff surgery is associated with moderate to severe postoperative pain. among different analgesic strategies, continuous interscalene block is reported to be an efficient method, reducing opioid consumption and allowing rapid rehabilitation; however, patients may develop a transient neuropathy after surgery, which could have a significant impact on active patients. this study is designed to compare the incidence of brachial plexus injury in two groups of patients: one with a continuous interscalene block, and one with a patient control analgesia of morphine (self-iv administration of morphine). all patients will have a clinical neurological exam with a preoperative electromyogram in order to rule out a pre-existing neuropathy. another clinical neurological exam with electromyogram will be performed between 4 and 6 postoperative weeks and, if pathological repeated at 6 months, 9 months and 12 months. the surgery will be done under general anesthesia for all patients.

Eligibility criteria:
inclusion criteria: * patients planned for rotator cuff repair * asa 1, 2 and 3 * age 16 years and more exclusion criteria: * peripheral neuropathy * pre-existing brachial plexus injury * diabetes mellitus * alcoholism * drug addiction

Keywords: electrophysiological study nerve block analgesia, patient-controlled shoulder surgery