Kornimate/medical-research-clean huggingface dataset:
effects of cocoa flavanols on human cognitive function

Conditions: Neural Degeneration

Summary: to determine the acute and chronic effects of cocoa derived flavonoids on cognitive function in healthy older adults.

this is a randomised controlled double blind cross over study investigating the acute effects of high flavanol (495mg) compared to low flavanol (23mg)cocoa drink on cognitive function in a healthy older adult population (n=60). the primary outcome measure of this study is to determine the effects of the flavanol intervention on cognitive measures of executive function and attention and the secondary measures of blood pressure and to determine whether any observed effects are paralleled by plasma flavanol levels.

Eligibility criteria:
inclusion criteria: * aged 62 - 75 years * a signed consent form exclusion criteria: * blood pressure \> 160/90 mmhg * haemoglobin (anaemia marker) \< 125 g/l * gamma gt (liver enzymes) \> 80 iu/l * had suffered a myocardial infarction or stroke in the previous 12 months * suffers from any gastrointestinal/stomach disorder * suffers from any blood-clotting disorder * on medication for hypertension * suffers from any metabolic disorders (e.g. diabetes or any other endocrine or liver diseases) * depression or major mental illness * any dietary restrictions or on a weight reducing diet * drinking more than 21 units per week * on any medication affecting blood clotting * smoking * vegans
an effectiveness and safety study of acetaminophen extended release caplets in treating muscle aches and soreness that occur after a marathon race

Conditions: Pain

Summary: the purpose of this study is to compare the effectiveness of acetaminophen extended release caplets to placebo in treating the muscle aching and pain (soreness) that occurs after a marathon.

this is a randomized, double-blind, placebo-controlled study to compare the effectiveness and safety of acetaminophen and placebo in treating muscle aching and pain (soreness) that occurs in subjects who complete a marathon. subjects are randomized to receive acetaminophen extended release caplets, 3900 mg/day (two 650 mg caplets taken three times a day, for four days) or placebo (two placebo caplets taken three times a day, for four days). the primary measurement of efficacy is the average change from baseline in muscle soreness, on day 1, the day of the marathon. safety assessments consist of monitoring adverse events, and a physical examination at the screening visit, including vital signs, weight, a medical history review, and a urine pregnancy test for females of childbearing potential. the hypothesis of the study is that acetaminophen is more effective than placebo in the relief of post-race muscle aching and pain (soreness) score on the evening of the race. two acetaminophen 650 mg extended release caplets, taken by mouth, three times a day over a four day period or two placebo caplets, taken by mouth, three times a day over a four day period.

Eligibility criteria:
inclusion criteria: * patients must be able to comply with the study schedule * be able to swallow the study medication * complete the marathon * not take any analgesics after completing the marathon and before their eligibility to participate in the study has been determined * rate their muscle soreness at least a 4, on a 0 - 10 point scale exclusion criteria: * previous diagnosis of osteoarthritis * currently have or have had a medical condition that may be relevant in one's eligibility to participate in the study * known hypersensitivity to acetaminophen * unable to understand or follow the instructions for the study * taken any investigational medication within 30 days of the marathon

Keywords: muscle ache pain soreness acetaminophen
intravitreal anti-vegf in exudative amd with epiretinal membranes

Conditions: Epiretinal Membrane; Age Related Macular Degeneration

Summary: study designed to evaluate the effect of significant erm on the visual and anatomic outcomes of intravitreal anti-vegf therapy for eamd.

gass in 1987 described three cases of epiretinal membrane (erm) associated with wet macular degeneration. since then we have seen that is not rare to find the coexistence of these entities. an erm may produce intrinsic disorganization of the outer retina leading to persistent increased macular thickness and/or edema. this persistent edema may affect the effectiveness in the treatment of exudative age-related macular degeneration (eamd). therefore, this study was designed to evaluate the effect of significant erm on the visual and anatomic outcomes of intravitreal anti-vegf therapy for eamd.

Eligibility criteria:
inclusion criteria: * significant epiretinal membrane * anti-vegf treatment for age-related macular degeneration exclusion criteria: * uveitis * macular disorders * diabetic retinopathy * vascular occlusions

Keywords: choroidal neovascularization epiretinal membrane anti-vegf
translational research center in lung cancer disparities (tracer) project 2

Conditions: Smoking; Smoking Behaviors; Smoking Cessation; Stress Reaction

Summary: the purpose of this study is to examine racial differences in smoking behaviors and stress responses between african american and white male smokers.

cigarette smoking is a leading cause of morbidity and mortality from lung cancer among adults in the us. stress relief and smoking cessation is the best preventive strategy for reducing lung cancer risk and addressing racial disparities in outcomes. despite this, racial differences are found among those that make quit attempts. stress has been found to be related to smoking initiation, maintenance, and relapse. yet, differences in stress responses have not been examined between african american and white smokers. therefore, this study will examine racial differences in stress responses and smoking behaviors between african american and white male smokers

Eligibility criteria:
inclusion criteria: * african american and white males * between the ages of 18-75 years old * smoke at least 5 to 10 cigarettes per day exclusion criteria: * smokers who have a serious cognitive disorder * have a personal history of lung cancer * personal history of usage of illicit drug and alcohol abuse * enrollment in a smoking cessation treatment program during the past 6 months * current use of a nicotine replacement therapy * have any positive responses on the mini international neuropsychiatric interview (mini) screener
a phase ii study of cabozantinib (xl184) therapy in castrate resistant prostate cancer (crpc) with visceral metastases

Conditions: Prostate Cancer

Summary: this research study is being done to measure the clinical benefit associated with cabozantinib (xl184) in men who have prostate cancer that has spread to visceral organs (organs other than bone or lymph nodes) and no longer responds to initial hormonal (castration) therapy. this type of prostate cancer is called metastatic, castrate-resistant prostate cancer.

cabozantinib (xl184), a multi-targeted tyrosine kinase inhibitor, has demonstrated a powerful clinical phenotype in men with metastatic castrate resistant prostate cancer (mcrpc) both before and after chemotherapy. this phenotype consists of rapid reduction in pain (when present) and improvement in bone scans that may or may not be accompanied by decrease in serum prostate specific antigen (psa) concentrations. in previous studies of cabozantinib in advanced prostate cancer, patients with visceral disease have been excluded. hence, this protocol creates a unique opportunity to define the activity of this disease in the population of men with visceral disease - a marker for poorer prognosis in mcrpc. primary objectives: - to assess the clinical benefit (complete response + partial response + stable disease) of cabozantinib in patients with mcrpc with visceral metastases. secondary objectives: * to assess the impact of cabozantinib on numbers live circulating tumor cells (ctcs) using nanovelcro chips * to test the feasibility of measuring variation in gene expression in circulating tumor cells (ctcs) in response to therapy. * to determine if there is an impact of cabozantinib on live circulating tumor cell (ctc) number and patterns of gene expression. * to measure the impact of cabozantinib on serum hgf (hepatocyte growth factor) and vegf (vascular endothelial growth factor) levels in men with metastatic, castration-resistant prostate cancer (mcrpc). * to assess the safety and tolerability of lower doses (i.e. doses below 100 mg daily) of cabozantinib in mcrpc with visceral involvement. * to collect blood, urine, tissue, and plasma which may be used determine if there are germline genetic variations that correlate with toxicity. * to pilot correlations between molecular content between circulating tumor cells (ctcs), large oncosomes, and tumor tissue.

Eligibility criteria:
key inclusion criteria - mcrpc that includes visceral disease. visceral metastatic disease is defined as solid organ infiltration that is not bone or lymph node metastases. key exclusion criteria * recent history (\<6 months) of gastrointestinal hemorrhage requiring blood transfusion. * tumor involvement in the intestinal lining which the treating physician deems at risk for perforation with rapid tumor response.

Keywords: liver metastasis lung metastasis metastatic castrate-resistant prostate cancer
miniarc study: long-term effectiveness trial for ams sling systems

Conditions: Stress Urinary Incontinence in Women

Summary: multi-center, prospective, single arm study. qualify patients will receive treatment for stress urinary incontinence by implantation of an ams sling system. the study is a long-term evaluation of effectiveness and safety associated with ams sling systems.

this study is a post market study to evaluate variables of the implantation, safety, and outcomes in a representative population (sui) indicated for ams sling systems at various time points. the study duration is 2 year with an estimated 200 enrollment. the outcomes of the treatment will be evaluated via pad weight test, cough stress test, qols,and other patient administered questionnaires.

Eligibility criteria:
inclusion criteria: * females 18 years or older who have confirmed sui defined as involuntary loss of urine that occurs during physical activity, such as coughing, sneezing, laughing, or exercise. exclusion criteria: * unwilling or unable to sign icf * unable to understand the study or has a history of non-compliance with medical devices * contradicted for the implantation surgery due to the following: renal sufficiency, urethral diverticulum, fistula, significant prolapse conditions, pregnant, pelvic cancer, compromise immune system,vulvar pain,blood coagulation disorder, and chronic abscesses * pelvic prolapse greater than grade 3 * is, in the investigator's opinion, otherwise unsuitable for the study

Keywords: stress urinary incontinence in women
the neutrophil-to-lymphocyte ratio to exclude pancreatic fistula

Conditions: Pancreas Neoplasm

Summary: there is still no consensus on whether drain fluid amylase (dfa) level, c-reactive protein (crp) level, or complex scores predict clinically relevant postoperative pancreatic fistula (cr-popf). the aim of this study is to determine the accuracy of simple biochemical parameters (leucocytes, neutrophils, lymphocytes, neutrophil to lymphocytes ratio (nlr), at postoperative days 1 and 3) to exclude the diagnosis of cr-popf.

from january 1, 2012 to december 31, 2020, consecutive patients underwent pd performed at institut paoli-calmettes for various pathologies. data were entered prospectively into a clinical database (nct02871336). the cohort was split into 3 groups: * a training cohort ; * an internal validation cohort (paoli calmettes institute); * an external validation cohort (rennes pontchaillou hospital).

Eligibility criteria:
inclusion criteria: * patients who underwent pancreatoduodenectomy exclusion criteria: * total pancreatectomy * enucleation

Keywords: pancreatic fistula neutrophil-to-lymphocyte ratio pancreatoduodenectomy
williams syndrome strength, hormones, activity & adiposity, dna programming, eating study

Conditions: Williams Syndrome; Lipedema

Summary: williams syndrome (ws) is a rare microdeletion genetic disorder that has a broad phenotype including many endocrine and metabolic abnormalities. dr. pober and colleagues at mgh have reported the following findings in adults with ws: abnormal body composition (excess body fat accumulation with a lipedema phenotype), decreased bone mineral density, abnormal glucose tolerance, and reduced lean mass. despite the high prevalence and potential effect of metabolic abnormalities on the health of persons with ws, their full phenotypic range, potential causal factors (either genetic and/or hormonal) along with their impact on other aspects of health (such as risk of falls and fractures or interaction with emotional behavioral concerns) remain incompletely characterized. the purpose of the current study in a large cohort of subjects with ws is to: collect further information to characterize the timing of onset and distribution of body fat; better characterize hormonal status of ws subjects; and screen for genetic variation using single-nucleotide-polymorphism (snp) analysis that could elucidate genetic contributors to the lipedema phenotype as well as the other observed metabolic and bone abnormalities.


Eligibility criteria:
for those participating in-person at massachusetts general hospital: inclusion criteria 1. male or female age 18-70 years old 2. diagnosis of williams syndrome (ws), established by experienced clinician, parent report, or confirmed by genetic testing such as fish (fluorescent in situ hybridization) or chromosomal microarray (ws only) 3. availability of a parent or guardian to review details of the study with their family member with ws and participate in the consent process (all ws regardless of age) 4. availability of a parent or guardian to provide selected medical information (ws only) exclusion criteria 1. history of weight loss surgery or liposuction 2. positive urine pregnancy test (females only) 3. obesity or abnormal fat distribution due to a known secondary cause (except ws) such as cushing syndrome, hiv-infection, etc.

Keywords: williams syndrome lipedema body composition glucose bone density
transcatheter arterial micro-embolization (tame) using nexsphere-f in patients with chronic pain in elbow or wrist

Conditions: Osteoarthritis

Summary: in patients with chronic elbow or wrist pain, the pain is controlled by conventional conservative therapy the pain reduction effect of nexsphere-f embolization in patients who need additional treatment it is intended to demonstrate safety.

this clinical trial is a single cancer, single center, open label, and pilot clinical trial that demonstrates the performance and safety of nexsphere-f for patients aged 19 to 80 who need additional treatment because their pain is not controlled even after taking existing treatments. in addition, through this clinical trial, complications of embolization and nexsphere-f and it checks the safety of side effects. therefore, in this study, tame treatment for patients with chronic elbow pain 2 to 7 months, 1 month later, 3 months, 6 wah vas score reductions and quickdash scores, prtee score primary 6 evaluate the reduction rate of medication, discontinuation rate of combination therapy, and occurrence of abnormal cases during the follow-up period. for patients with chronic wrist pain, vas score after 2 to 7 days, 1 month, 3 months, and 6 months of tame treatment quickdash score reduction rate, drug reduction rate after 6 months, discontinuation rate of combination therapy, and follow-up period the investigators will evaluate the effectiveness and safety of nexsphere-f by evaluating whether abnormal cases occur during the period.

Eligibility criteria:
inclusion criteria: 1. those aged 19 to 80 2. anyone who can provide a consent form 3. a person with a life expectancy of at least 12 months 4. those who have not responded or failed in preservation treatment for at least three months(e.g. nsaids/physical therapy/steroidal joint injections, etc.) 5. vas score of 4 or higher and moderate-severe elbow or wrist pain exclusion criteria: 1. those with a vas score of less than 4 and mild elbow or wrist pain 2. chronic renal insufficiency(serum creatinine \> 2mg/dl) 3. allergy to iodide contrast agents that do not respond to steroids 4. those with acute infection or malignancy 5. those who have previously had elbow or wrist surgery 6. those with bleeding diabetes that cannot be calibrated
treatment of acute, unstable chest wall injuries

Conditions: Blunt Injury of Thorax; Flail Chest; Chest Wall Injury Trauma; Rib Fracture

Summary: unstable chest injuries are common in poly trauma patients. they can lead to severe pulmonary restriction, loss of lung volume, difficulty with ventilation and can render the patient to require intubation and mechanical ventilation. traditionally these injuries have been treated non-operatively, however in the past decade there has been numerous studies suggesting improved outcomes with surgical fixation. surgical fixation can significantly decrease time spent in icu as well as day on mechanical ventilation. the investigators aim is to conduct a randomized control trial of these injuries, to compare non-operative treatment with surgical fixation. the investigators' hypothesis is that surgically treated patient will have significantly improved outcomes compared to those treated non-operatively.


Eligibility criteria:
inclusion criteria: * age \>16 or skeletal maturity * meeting one of the two indication for surgical fixation of chest wall injury: 1. flail chest, defined as follows: * 3 unilateral segmental rib fractures; or * 3 bilateral rib fractures; or * 3 unilateral fractures combined with sternum fracture/dissociation note: at least 3 of the rib fractures involved in the flail segment must demonstrate displacement. 2. severe deformity of the chest wall (diagnosed by ct scan). defined as follows: * severe (100%) displacement of 3 or more ribs or * marked loss thoracic volume/caved in chest (\>25% volume loss in involved lobe(s)); or * overriding of 3 or more rib fractures (by minimum 15mm each); or * two or more rib fractures associated with intra-parenchymal injury - ie ribs in the lung, in the parenchyma exclusion criteria: * anatomic location of rib fractures are not amenable to surgical fixation (eg fractures directly adjacent to spinal column) * rib fractures primarily involving floating ribs (ribs 10-12) * home oxygen (o2) requirement * other significant injuries that may require long term intubation: * severe pulmonary contusion (defined as pao2/fio2 ratio \<200 with radiological evidence of pulmonary infiltrates within 24 hours of thoracic trauma) * severe head injury/traumatic brain injury - (gcs ≤ 8 at 48 hrs post injury. if unable to assess full gcs due to intubation or other causes, gcs motor ≤4 at 48 hrs post injury) * upper airway injury requiring long term intubation and mechanical ventilation (e.g. tracheal disruption) * acute quadriplegia/quadraparesis * head and neck burn injuries, or inhalation burn injuries * dementia or other inability to complete follow-up questionnaires * medically unstable for or (e.g. haemodynamic instability, acidosis, coagulopathy, etc.)\* or unlikely to survive 1 year follow-up, in the opinion of the attending physician * lack of informed consent from patient or substitute decision maker * randomization \> 72 hours from injury * orif \> 96 hours from injury (if randomized to surgical fixation group) * age \> 85

Keywords: unstable chest injury flail chest chest wall injury rib fracture
evaluation of the quality of life in patients referred for transjugular intrahepatic portosystemic shunt

Conditions: Chronic Liver Disease

Summary: patient with advanced chronic liver disease often present portal hypertension which may lead to bleading or ascites. one of the treatment of portal hypertension in these patients is the placement of a transjugular intrahepatic portosystemic shunt (tips). the indications for placing tips take on various clinical presentations, the most classic being digestive haemorrhage by rupture of oesophageal and/or gastric varices and refractory ascites. tips placement involves changes in haemodynamics and liver function that may alter the patients' condition and quality of life. very few articles have evaluated the quality of life of these patients and when quality of life is evaluated it is mostly with not adapted or not validated scales. the main objective of this study is to evaluate the quality of life of patients who have undergone tips using a validated and standardised quality of life questionnaire (the sf-36 questionnaire).


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * patients referred to the tips service between january 2012 and october 2020 at the university hospitals of strasbourg, with a follow-up period of at least 1 month * subjects who have not expressed any opposition to the use of their medical data for research purposes * for subjects invited to fill in the questionnaires: subject having expressed his/her agreement with the use of his/her medical data in the framework of the current study exclusion criteria: * diseased patient * liver transplant patient following tips * pregnancy * patient in a vulnerable situation * patient under court protection, guardianship or trusteeship * difficulties in understanding the questionnaire * impossible to give the subject informed information (subject in an emergency situation, difficulties in understanding the subject, etc.) * subject under legal protection

Keywords: chronic liver disease tips quality of life
development of domiciliary program on improving activities of daily living program for patients with stroke

Conditions: Stroke

Summary: the purpose of this study was to investigate the effects of the domiciliary care- activities of daily living program on activities of daily living (adl), motor, cognition, perception, sensory, quality of life, and depression for patients with stroke.

administering adl and recovery of adl functions are the primary efficacy indicators in long-term care and the main treatment goals in rehabilitation for patients with stroke. residential rehabilitation is a direct way to observe patients' living environment and provides feasible adl treatment plans for patients with stroke living at home or in the community. the purpose of this study was to investigate the effects of the domiciliary care- activities of daily living program on activities of daily living, motor, cognition, perception, sensory, quality of life, and depression. the eligible participants were recruited and assigned into two groups: adl home program and control group who received traditional rehabilitation in hospital. the primary outcome measures were the canadian occupational performance measure, the barthel index-based supplementary scales, the frenchay activities index, and adl domain of the stroke impact scale. the secondary outcome measures were the fugl-meyer assessment, the mini mental state examination, the test of visual perceptual skills-third edition, and the center of epidemiological study-depression.

Eligibility criteria:
inclusion criteria: * diagnosis of stroke * aged \> 20 years * score 2-4 of the modified rankin scale * capability of following instructions * willing to participants to the study exclusion criteria: * diagnoses of dementia and parkinson's disease * physical limitations because of orthopedics diseases * peripheral nerve injury