Kornimate/medical-research-clean huggingface dataset:
efficacy study of articaine lozenge to enhance the procedural compliance of the adults undergoing gastroduodenoscopy

Conditions: Dyspepsia; Hematemesis; Abdominal Pain; Heartburn

Summary: the purpose of this study is to examine in prospective, double-blinded randomised manner the ability of novel articaine-containing lozenge to enhance the procedure related compliance (compared to placebo) of the adult patients undergoing upper gastrointestinal endoscopy.


Eligibility criteria:
inclusion criteria: * elective procedure * weight over 40 kg * american society of anesthesiology class i-iii * first upper gi endoscopy procedure * finnish or/and swedish speaking exclusion criteria: * amide and/or esther local anaesthetic allergy * paraben allergy * child-pugh grade b/c liver failure * renal insufficiency (calculated glomerular filtration rate under 60 ml/min/1.73 m2 according to cockcroft-gault scale ) * dementia * those presenting with swallowing problem * chronic pain condition * chronic use of pain medication * pregnancy * lactation

Keywords: upper gastrointestinal tract endoscopy lozenge articaine dyspepsia hematemesis abdominal pain heartburn
establishment of a bank of biospecimens for future research on age-related cognitive disorders

Conditions: Dementia; Alzheimers Disease

Summary: this study is collecting tissue specimens (blood, urine and saliva) from up to 1000 patients, with and without cognitive disorders, to store in the bio bank for future research. the specimens could be used in future research projects that could help improve the accuracy of diagnosis of a disease, predict who might develop a disease, help monitor the disease, or improve the understanding of the disease. patients are only being recruited from beaumont hospitals geriatric clinic.

up to 1000 patients, with or without diagnosed cognitive disorders, are asked to participate by providing the investigators with blood, urine and saliva specimens to be stored in a bio bank for future research. patients will be asked to participate on a yearly basis for up to 5 to 10 years by providing the investigators with the above-mentioned specimens, and also having a physical exam and having some cognitive testing performed at the initial visit and yearly visits. examples of the types of research are: new methods for improving the diagnosis and treatment of age-related cognitive disorders, new areas of biology, new areas of biotechnology, and possibly genetic research. if you do not want your specimens used for any specific type of research, you may specify that on the consent form.

Eligibility criteria:
inclusion criteria: 1. at least 60 years of age. 2. willing and able to complete all specimen donations and neuropsychological examinations. 3. individuals identified as having some form of cognitive impairment require a study partner with 1-2 times per week contact (can be in person and/or telephone), who will accompany them to study visits(s). exclusion criteria: 1. presence of significant sensory deficits (e.g., visual or hearing), motor deficits (e.g., paralysis), or medical conditions that would preclude the completion of the neuropsychological or other study instruments. 2. dms-iv diagnosis of substance abuse disorder. 3. presence of a major medical or terminal illness that may affect the participation of the patient in the study. 4. known active malignancy, or history of malignancy within the last 5 years (other than basal cell carcinoma), severe organ failure, metabolic or hematologic disorders, or post-encephalitic syndrome.

Keywords: dementia alzheimers disease cognitive disorders tissue banking
prediction of response to bariatric surgery in patients with severe obesity

Conditions: Body Weight Changes

Summary: this is an retrospective and prospective (ambispective) study with data collection from volunteer patients who passed an mmpi-2-rf (minnesota multiphasic personality inventory-2-restructured form) questionnaire in the preoperative phase of a bariatric surgery project. the evolution of their bmi will be correlated to psychological dimensions collected in patient questionnaires, before and after bariatric surgery. the presence of possible risk factors such as depression, anxiety, eating disorders, quality of life, satisfaction and the perception of body, could make it possible to establish adapted therapies before surgery, in order to attenuate or eliminate the presence of these factors, and improve bmi evolution and bariatric surgery success.

a first phase of data collection will concern data from the mmpi-2-rf questionnaire as well as clinical data, collected during preoperative consultations. for the second phase, post-operative data will be collected, during a routine follow-up consultation in the nutrition department, where specific psychological questionnaires are taken by patients.

Eligibility criteria:
inclusion criteria: * having been treated in the nutrition department for severe obesity and considered for bariatric surgery because having met the criteria validating bariatric surgery: * having passed the mmpi-2-rf questionnaire between january 1, 2014 and december 31, 2023 in the preoperative phase, as part of psychological follow-up * having benefited from bariatric surgery or patients who have abandoned the surgery plan for a reason other than a medical contraindication. * informed of the study, having agreed to participate and not having opposed the use of their data exclusion criteria: * subjects who generated an invalid mmpi-2-rf questionnaire, according to the test validity criteria (verified by the principal investigator) * subjects who expressly objected to the use of their data for this study * subjects who have not undergone bariatric surgery due to a medical contraindication. * patient unable to understand the study or complete the post-operative phase visit * persons under guardianship or curators or under legal protection
aqueous concentrations and pge2 inhibition of ketorolac 0.4% vs. bromfenac 0.09% in cataract patients: trough drug effects

Conditions: Cataract

Summary: the purpose of this study is to compare the ability of two different topical nsaids (non-steroidal anti-inflammatory medications used for pain relief) to reach the back of the eye and to stop inflammation. the study will conclude on the day of your cataract surgery.


Eligibility criteria:
inclusion criteria: 1. healthy male/female 21 years of age of older. 2. patient understands and is willing to sign the written informed consent form 3. likely to complete the entire course of the study. 4. patient is scheduled to undergo cataract surgery 5. female patients of childbearing potential must have had a regular menstrual cycle prior to study entry (a female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation). 6. patient is willing and able to administer eye drops and record the times the drops were instilled exclusion criteria: 1. patient has been using a topical nsaid within 1 week of study entry 2. patient has a known sensitivity to any of the ingredients in the study medications 3. patient has sight in only one eye 4. patient has a history of previous intraocular surgery 5. patient's doctor has determined they have a condition (i.e., uncontrolled systemic disease) or are in a situation that may put them at significant risk, confound the study results or may interfere significantly with their participation in the study 6. female patients who are pregnant, nursing an infant or planning a pregnancy 7. patients who are currently involved in another investigational study or have participated in one within the 30 days prior to entering this study
post operative urinary retention (pour) following thoracic oncological surgery

Conditions: Urinary Retention

Summary: this is a feasibility study looking at whether the use of tamsulosin could lower the high incidence of postoperative urinary retention (pour) in older men who undergo an oncological thoracic surgical procedure for suspected or confirmed cancer. in addition, the study will try to identify the time of resumption of presurgical urinary function post tamsulosin administration.

post-operative urinary retention (pour) is a significant problem in post-operative patients. the incidence varies, but can reach up to 70%, which most commonly affects older men with enlarged prostates. even after adjusting for the modifiable risk factors, such as decreased intraoperative foley use and post-operative narcotic use, the incidence remains high. this causes an increase in urinary tract infections, patient discomfort, longer hospital stays, and occasionally further urologic complications. studies have shown that the use of tamsulosin, an alpha1-adrenergic receptor blocker, may decrease the incidence of pour by improving urinary flow via relaxation of the smooth muscle tissue. therefore, the goal of our study is to investigate whether tamsulosin (flomax) can be used to lower incidence of pour in older men undergoing an oncological thoracic surgical procedure. this is a pilot/feasibility/ early efficacy study to determine if treating men \> 55 years of age with tamsulosin prior to a thoracic oncological surgery will prevent postoperative urinary retention (pour). subjects will be provided with a prescription for tamsulosin (generic) to be taken 7 days prior to scheduled surgery. for research purposes, post-surgical spontaneous voids will be measured, and any residual urine in the bladder will be assessed and measured using a bladderscanner. this data will be used to determine postoperative urinary retention (pour). additionally, standard of care bladder management will be used if the subject did not spontaneously void or had excess urine residual. the algorithm in the table below will guide bladder management decisions.

Eligibility criteria:
inclusion criteria: * males * ≥55 years old * planned thoracic oncological surgical procedure of a video assisted oncological surgical procedure for suspected or confirmed cancer. * surgery scheduled more than 7 days from the time of consent exclusion criteria: * using tamsulosin already * known allergy to tamsulosin or sulfa drugs * current use of boceprevir * resting systolic blood pressure \<100 * orthostatic hypotension of \>20mm hg systolic and/or 10mm hg diastolic pressure from sitting to standing (after 2 minutes of standing) as measured at the time of consent * known history of hypotension * known diagnosis of congestive heart failure (chf) and valvular heart disease * history of prior prostate surgery (prostatectomy, trans-urethral resection)

Keywords: urinary retention post surgery urinary retention thoracic surgery spontaneous voiding bladder retention tamsulosin (flomaxtm) kidney injury men undergoing thoracic oncological surgical procedure bladderscanner
randomized trial of depression follow-up care by email

Conditions: Depressive Disorders

Summary: the primary objective of this study is to test in a randomized effectiveness trial if e-mail delivered cognitive behavioural treatment is an effective follow-up care approach in the treatment of depression under clinically representative conditions.

depression belongs to the most prevalent mental disorders and often goes along with a high burden of disease. although the efficacy and the effectiveness of psychological treatments for depressive disorders have been demonstrated, there remains the problem of maintaining the benefits achieved during the initial treatment phase. therefore options of follow-up care have to be considered. since access to psychotherapeutic treatments is limited and costly, internet-based interventions can offer a feasible opportunity for follow-up care in order to enhance the long-term effectiveness of psychotherapy.

Eligibility criteria:
inclusion criteria: * depressive disorder: f32.0-f32.2; f33.0-f33.2; f34.1 according to icd-10 * precursory cbt * internet access exclusion criteria: * no knowledge of the german language * risk of suicide * acute psychosis or psychotic symptoms * established concurrent in vivo cbt after discharge from inpatient cbt

Keywords: follow up care e-mail effectiveness depressive disorders
study of pain catastrophizing-2 (spac-2)

Conditions: Osteoarthritis, Knee

Summary: this study experimentally manipulates pain catastrophizing in order to investigate the neural mechanisms by which pain catastrophizing influences the experience of pain in different ethnic groups among adults with knee osteoarthritis. participants will be randomized to either a single session cognitive-behavioral intervention to reduce pain catastrophizing or a pain education control group.


Eligibility criteria:
inclusion criteria: * symptomatic knee oa exclusion criteria: * younger than 45 years of age or older than 85 years of age * prosthetic knee replacement or other clinically significant surgery to the arthritic knee * uncontrolled hypertension (\>150/95) * heart disease including heart failure * peripheral neuropathy in which pain testing was contraindicated * systemic rheumatic disorders including rheumatoid arthritis, systemic lupus erythematosus, gout, and fibromyalgia * neurological diseases such as parkinson's, multiple sclerosis, stroke with loss of sensory or motor function, or uncontrolled seizures * significantly greater pain in body sites other than in the knee * daily opioid use * hospitalization within the preceding year for psychiatric illness * currently pregnant or nursing/breastfeeding

Keywords: catastrophizing cognitive-behavior therapy
pyruvate kinase deficiency epidemiological study (piece)

Conditions: Pyruvate Kinase Deficiency

Summary: pyruvate kinase deficiency (pkd) is the most common red cell glycolytic enzyme defect causing hereditary non-spherocytic hemolytic anemia, caused by mutations in the pklr gene. the main goal of this study is the diagnosis of pyruvate kinase deficiency in patients who exhibit chronic anaemia and/or splenomegaly and/or judiance and/or hyperbilirubinemia and/or history of prolonged neonatal jaundice and/ or cholelithiasis of undetermined aetiology.

pyruvate kinase deficiency is the most common red cell glycolytic enzyme defect causing hereditary non-spherocytic hemolytic anemia, caused by mutations in the pklr gene. pklr encodes a pyruvate kinase that catalyzes the transphosphorylation of phosphoenolpyruvate into pyruvate and atp. the current treatment options are red cell transfusions, chelation and splenectomy. this is an international, multicentre, epidemiological and observational study. the patients fulfilling the inclusion criteria will be enrolled into the study and genetically tested for pklr mutations via next generation sequencing (ngs). any mutation being detected by ngs, will be confirmed by sanger sequencing. pklr-positive samples (homozygous or compound heterozygous for pathogenic variants) will be analysed for the identification of potential biomarkers via liquid chromatography multiple reaction-monitoring mass spectrometry (lc/mrm-ms) and compared to a merged control samples in order establish a pkd specific biomarker.

Eligibility criteria:
inclusion criteria: * informed consent is obtained from the participant or legal representative * the participant is equal or older than 5 years or equal or younger than 30 years old * the participant exhibits the following symptoms of no obvious etiology: * chronic anaemia and/or * splenomegaly and/or * jaundice and/or * cholelithiasis and/or * cholecystitis and/or * hyperbilirubinemia and/or * history of prolonged neonatal jaundice * the participant is clinically diagnosed with pk deficiency exclusion criteria: * inability to provide informed consent * the participant does not suffer from chronic anaemia and splenomegaly and jaundice and cholelithiasis and cholecystitis and hyperbilirubinemia and history of prolonged neonatal jaundice * the etiology of chronic anaemia or splenomegaly or jaundice or cholelithiasis or cholecystitis or kernicterus is clearly determined and is not due to pk deficiency * the participant is younger than 5 years or older than 30 years old * previously enrolled in the piece study * participant in custody

Keywords: pyruvate kinase deficiency chronic anaemia biomarker
predicting lung injury from transfusion in patients with liver disease

Conditions: Transfusion-related Acute Lung Injury; Chronic Liver Disease; Gastrointestinal Bleeding

Summary: a certain molecule floating in the blood may represent a risk of lung injury after a transfusion. we are determining whether detection of this molecule on a simple blood clotting test will predict the development of lung injury due to transfusion in bleeding patients with chronic liver disease.


Eligibility criteria:
inclusion criteria: subjects will be eligible to participate in the study if they meet all of the following criteria: 1. admit to an icu due to gastrointestinal bleeding and an inr \> 1.5 2. patient has chronic liver disease defined as 1 or more of the three following diagnostic criteria: 1. previous diagnosis of chronic liver disease or imaging or biopsy diagnosis of cirrhosis 2. signs of portal hypertension (ascites, varices, hypersplenism) 3. laboratory evidence of synthetic dysfunction (inr\>1.5, bilirubin\> 2.0, albumin\< 2.5) and ≥2 physical exam findings on admission associated with chronic liver disease (palmar erythema, spider angiomata, asterixis, caput medusa, gynecomastia) exclusion criteria: subjects will be ineligible to participate in the study if they meet any of the following criteria 1. patient under age 18 or pregnant or incarcerated 2. patient meets criteria for acute respiratory distress syndrome (ards) (pao2/fio2\<165) 3. patient admitted to icu for re-bleed on same hospital admission or has already received \>4 units of plasma. 4. history of inheritable or acquired clotting or bleeding disorder 5. patient actively anticoagulated or has recently received (within 72h) vitamin k antagonists, direct thrombin inhibitors, heparins or xa antagonists

Keywords: respiratory distress syndrome, adult blood component transfusion gastrointestinal hemorrhage blood coagulation
a multicenter pilot study of pallidal deep brain stimulation for cervical dystonia

Conditions: Cervical Dystonia

Summary: the purposes of this study are: * to determine if bilateral pallidal deep brain stimulation results in improvement in neck postures/movements; * to determine if bilateral pallidal deep brain stimulation results in improvement in quality of life; and * to document the adverse effects of surgery in patients with cervical dystonia.

deep brain stimulation (dbs) of the globus pallidus has been proposed as a treatment for cervical dystonia. at present there are only anecdotal reports of benefit. the objective of this project is to prospectively assess the outcomes of dbs on cervical dystonia in a blinded manner. our hypothesis is that in patients refractory to medical management, bilateral pallidal dbs will reduce the severity of cervical dystonia at 1 year follow up. the research plan is that of a feasibility study, examining outcomes of 10 patients who would be referred for surgical management due to the severity of their disease. the toronto western spasmodic torticollis rating scale (twstr) will be preformed by a blinded neurologist at the completion of the trial.

Eligibility criteria:
inclusion criteria: * adult patients, male or female * diagnosed with cervical dystonia by a movement disorders neurologist * has cervical dystonia alone, not generalized or multifocal * has had adequate trials of medical therapy exclusion criteria: * cognitive impairment * abnormalities on pre-operative magnetic resonance imaging (mri) * medical conditions precluding general anaesthetic or surgery * unstable psychiatric disease * previous brain lesions to treat cervical dystonia

Keywords: cervical dystonia deep brain stimulation
mastery learning in communication skills

Conditions: Communication Research; Communication, Personal; Burnout, Professional

Summary: the goal of this study is to determine whether mastery learning in communication skills can improve skills in a simulated environment and have translational improvements in outcomes. the main questions it aims to answer are: 1. does mastery learning improve skills in the simulation laboratory? 2. does mastery learning improve clinical skills as seen by milestone performance? and 3 does mastery learning improve burnout levels? the study is a multi-institutional randomized controlled trial of anesthesiology residents from five different residency programs. participants will be randomized to mastery training in communication skills and standard of care, which is vicarious learning. researchers will compare these two groups to see if mastery learning improves skills and translational outcomes.


Eligibility criteria:
inclusion criteria: * anesthesiology residents rotating at ann and robert h. lurie children's hospital of chicago exclusion criteria: * participant refusal * study participants who have already undergone the mastery learning in difficult conversations course.
evaluation of her2dx assay on treatment decisions in patients with early stage her2+ breast cancer: the her2breastdx

Conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Summary: to prospectively evaluate the impact of her2dx on the decision-making processes of the treating physicians and especially among the routine multidisciplinary tumour board, in defining type and setting of systemic therapy administration in patients with stage i-iii her2+ bc, and the degree of clinician's confidence in the treatment recommendation.


Eligibility criteria:
inclusion criteria: * patients ≥ 18 years of age; * histologically confirmed her2+ breast cancer; * stage i-iii breast cancer without evidence of distant metastases; * being candidate to neoadjuvant/adjuvant therapy and locoregional treatment (surgery +/- radiotherapy); * written informed consent, signed by the patient, to study-specific procedures (the consent will consist of 2 levels: level 1 specifically for patients enrolled in the primary endpoint cohort and level 2 for all patients); exclusion criteria: * her2- bc; * stage iv breast cancer; * lack of informed consent because of patient's incapable of discernment or unwilling to participate;

Keywords: her2 positive breast cancer patients with stage i-iii
fully hybrid 18f-psma pet/mri as one-stop approach for the diagnosis of clinically significant prostate cancer.

Conditions: Clinical Suspicion of Prostate Cancer

Summary: this project aims to evaluate the role of fully hybrid pet/mri with 18fpsma and multiparametric mr imaging (mpmri) as one-stop approach for the diagnosis of clinically significant prostate cancer (cspca). our main hypothesis is that adding 18f-psma pet to mpmri prior to biopsy, will reduce the number of false negative findings, while at the same time, allowing also to reduce the number of unnecessary prostate biopsies in patients with low-risk, clinically indolent pca.


Eligibility criteria:
inclusion criteria: 1. men at least 18 years of age referred with clinical suspicion of prostate cancer candidate for prostate biopsy 2. feasibility to undergo all procedures listed in protocol 3. ability to provide written informed consent exclusion criteria: 1. prior diagnosis of prostate cancer 2. contraindication to mri (e.g. claustrophobia, pacemaker, estimated gfr lower or equal to 50mls/min) 3. contraindication to prostate biopsy