Kornimate/medical-research-clean huggingface dataset:
assessing benefits of niraf detection for identifying parathyroid glands during total thyroidectomy

Conditions: Postoperative Hypoparathyroidism; Thyroid Disease; Thyroid Neoplasms; Thyroid Cancer

Summary: this study describes a single center, randomized, single-blinded clinical trial to assess the clinical benefits of the use of near infrared autofluorescence (niraf) detection with an fda-cleared device 'parathyroid eye (pteye)' for identifying parathyroid glands during total thyroidectomy. it compares risk-benefits and outcomes in patients undergoing total thyroidectomy where niraf detection with pteye for parathyroid identification is either used or not used.

inadvertent damage or excision of a healthy parathyroid gland (pg) following a total thyroidectomy (ttx) could result in transient hypocalcemia (\ 6 months) in 7% of the patients (1, 2). in both of these circumstances, patients would require calcium and active vitamin d supplementation in addition to a potentially prolonged hospital stay and/or unplanned hospital readmission adding to unnecessary burden and healthcare costs. these complications could be minimized with label-free intraoperative pg identification using near infrared autofluorescence (niraf) detection with a fiber-probe based approach as utilized in 'pteye', which is medical device that was recently fda-cleared. however, the true impact of this particular niraf-based approach on patient outcomes is yet to be determined the aim of this prospective single blinded randomized study is to compare 2 groups of patients: ttx patients operated using niraf detection technology with pteye as adjunct tool (niraf+) vs. patients operated without the adjunct technology (niraf-). the main objective of this study is to assess the benefit of intraoperative use of niraf detection technology via pteye during ttx procedures with regard to postoperative hypocalcemia, pg identification, pg auto-transplantation and inadvertent resection rates compared to standard of care.

Eligibility criteria:
inclusion criteria: (i) all patients eligible for total thyroidectomy (ttx), with or without lymph node dissection. (includes patients undergoing a ttx who have undergone a prior neck exploration for parathyroid disease or other but have an intact thyroid). (ii) all patients undergoing completion thyroidectomy. exclusion criteria: (i) patients with concurrent parathyroid disease. (ii) patients with incidental enlarged parathyroid discovered during ttx. (iii) patients undergoing thyroid lobectomy/partial thyroidectomy.
radiolabeled gallium-68 (68ga-psma) for pet/ct imaging to detect prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of the study is to find out whether imaging of the prostate with a new molecule called 68ga-psma can find prostate cancer. 68ga-psma has been shown in a large number of patients to be useful to find recurring prostate cancer following initial cancer treatment. this study is performed to test 68ga-psma whether it can be used to find prostate cancers that would be considered in need for treatment.

in this study, two different imaging tests are being compared: a) 68ga-psma positron emission tomography (pet)/computed tomography (ct) and b) magnetic resonance imaging (mri) of the prostate gland. participants already have received the mri, and the results were either suspicious of or definitive for prostate cancer. both tests (mri and 68ga-psma pet/ct) are expected to show tumor tissue when more aggressive, but one test could be more accurate than the other test. another important question is whether these imaging tests will perform as good or better than prostate biopsies in finding all prostate cancer lesions in need for treatment. if imaging would be comparable or better than biopsies, then imaging may be able to replace invasive biopsies for some indications in the future. to investigate these questions, participants are asked to undergo a 68ga-psma pet/ct before a planned prostate biopsy procedure. after the biopsy procedure is performed, investigators will compare the imaging results from 68ga-psma with those from the mri and determine which test is more accurate.

Eligibility criteria:
inclusion criteria: * recent mri of the prostate has resulted in at least one lesion suspected to represent prostate cancer (reported by the radiologist as pi-rads 3, 4 or 5 lesion) * treating physician has already indicated a need for a prostate biopsy procedure. * known gleason 6 or 7 prostate cancer or rising psa with either a) no prior biopsy or b) single or multiple negative prior biopsies. exclusion criteria: * prostate biopsy within 12 weeks before enrollment * acute prostatitis within the last 6 months * current non-urologic bacterial infection requiring active treatment with antibiotics * active other malignancy (except basal cell or squamous cell skin cancer) within the last 2 years * body weight greater than 350 lbs (158 kg) * inability or unwillingness to receive a prostate biopsy procedure * unable to lie flat, still, or tolerate a pet/ct scan * unable to provide own consent * concurrent severe and/or uncontrolled and/or unstable medical disease other than prostate cancer (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 6 months prior to study participation, unstable and uncontrolled hypertension, acute renal failure of any intensity, chronic renal or hepatic disease, severe pulmonary disease).
the adherence of proactive sleep apnea therapy

Conditions: Obstructive Sleep Apnea

Summary: the goal of this clinical trial is to compare the adherence to positive airway pressure (pap) therapy for newly diagnosed obstructive sleep apnea (osa) patients. the main question(s) it aims to answer are: 1. to compare the adherence of proactive therapy and conventional automatic-pap (apap) therapy short-term (3 months) and long-term (12 months) for newly diagnosed osa patients. 2. to compare health outcomes (ahi, nightly usage, leak, and patient-reported outcomes) between proactive therapy and conventional apap therapy.

this is a double-blind, randomized controlled superiority trial on newly diagnosed patients with obstructive sleep apnea. each participant will be provided with a apap device. the devices assigned to the test group will be modified to deliver the proactive therapy using artificial intelligence (ai). devices assigned to the control group will deliver the conventional apap therapy. a sleep technician will be in regular contact with participants and track the time spent interacting with each participant. at the conclusion of the first 3 months of the trial, participants who are acceptant to therapy will be asked if they would like to continue participating for an additional 9 months. data will be collected by the pap device and a series of self-reported questionnaires.

Eligibility criteria:
inclusion criteria: * must have a new diagnosis of moderate or severe osa (i.e., ahi \> 15 events/hour). * must be 18-70 years old. * no history of self-reported, uncontrolled, severe cardiovascular or neurological issues. * must be able to comply with all study requirements as outlined in the consent form. * must be able to follow the directions of the study doctor and research team. * must be able to understand english and be willing to provide informed consent. exclusion criteria: * prior use of pap machines. * subjects actively using bi-level pap or require oxygen therapy. * subjects who are medically complicated or who are medically unstable ( i.e., cancer, dementia, unstable cardiac or respiratory disease, or unstable psychiatric illness). * potential sleep apnea complications that, in the opinion of the clinician, may affect the health and safety of the participant. * inability or unwillingness to given written informed consent. * neuromuscular disease, hypoglossal-nerve palsy, severe restrictive or obstructive pulmonary disease, moderate-to-severe pulmonary arterial hypertension, severe valvular heart disease, new york heart association class iii or iv heart failure, recent myocardial infarction or severe cardiac arrhythmias (within the past 6 months), persistent uncontrolled hypertension despite medication use, active psychiatric disease, and coexisting non-respiratory sleep disorders that would confound functional sleep assessment. * pregnancy, planning to attempt to become pregnant, or breastfeeding.
people-powered medicine (ppm): rheumatoid arthritis non-responders to biologic therapies (rant)

Conditions: Rheumatoid Arthritis

Summary: the investigators are interested in enrolling patients with rheumatoid arthritis (ra) who had a difficult time getting their disease under control even after trying multiple ra therapies. the investigators believe that there may be common patterns in the genes of this group of ra patients compared to those with more "textbook ra." understanding genetic factors can help doctors to know in advance who may not respond to conventional therapies and start with treatments that work. learning about underlying genes that influence treatment may help the investigators to identify new targets for therapy, to ultimately improve the lives of patients with ra and inflammatory arthritis.

the investigators are looking for patients with rheumatoid arthritis (ra) with an inadequate response to tumor necrosis factor inhibitor (tnfi) and another biologic disease modifying anti-rheumatic drug (bdmard) or small molecule approved for treating ra. the investigators are conducting this research to learn more about ra and the genetic patterns associated with patients whose ra cannot be well controlled with most ra treatments. investigators anticipate that these patients will differ from "classic" ra patients in their biomarker and genetic composition and that they represent a mixed group of individuals who may be similar in ways that are not currently being measured.

Eligibility criteria:
inclusion criteria: * age \> 18 years * ra diagnosed by a rheumatologist * poor control of ra disease activity with tumor necrosis factor inhibitor (tnfi) and another biologic therapy or small molecule approved for ra exclusion criteria: * if the reason for failed tnfi therapy was due to a contraindication or adverse reaction * unable to provide blood sample

Keywords: treatment non-response tumor necrosis factor inhibitor (tnfi) rheumatoid arthritis disease modifying anti-rheumatic therapy biologic therapy
suitability of nitisinone in alkaptonuria 2

Conditions: Alkaptonuria

Summary: this is a proposal to develop the orphan designated drug, nitisinone, for the treatment of a rare mendelian disease, alkaptonuria (aku). thanks to our existing successful fundamental and clinical research (cell models, animal models, natural history studies), we are now ready for this final stage of clinical development of nitisinone for aku: a phase 3 clinical trial to prove efficacy. the results of developakure will allow us to make the case to the european medicines agency for marketing authorisation of nitisinone for aku, thereby contributing to the goal of the international rare diseases research consortium of developing 200 new therapies by 2020.


Eligibility criteria:
inclusion criteria: a patient must fulfil the following criteria in order to be included in the study: 1. diagnosis of aku any clinical manifestations of aku, such as clinical ochronosis or chronic back/joint pain. 3. age ≥25 years. 4. willing and able to visit the investigational site for study visits. 5. signed written informed consent given. - exclusion criteria: the presence of any of the following will exclude a patient from inclusion in the study: 1. currently pregnant or lactating. 2. female patient of child-bearing potential not using a reliable method of contraception. 3. known allergy to nitisinone or any of the constituents of the investigational product. 4. current malignancy. 5. uncontrolled hypertension (blood pressure greater than 180 mmhg systolic or greater than 95 mmhg diastolic). 6. unstable cardiovascular disease. 7. serum potassium \< 3.0 mmol/l. 8. egfr \< 60 ml/min . 9. alt \> 1.5 x upper limit of normal. 10. haemoglobin \< 10.0 g/dl. 11. platelets \< 100 x 109/l. 12. total white blood count \< 3.0 x 109/l or neutrophil count \< 1.5 x 109/l. 13. history of alcohol or drug abuse. 14. participation in another clinical study within 3 months of randomization. 15. treatment with nitisinone within 60 days of randomization. 16. psychiatric or somatic illness that interferes with compliance or communication with health care personnel. 17. foreseeable inability to cooperate with given instructions or study procedures. 18. any other medical condition which in the opinion of the investigator makes the patient unsuitable for inclusion. -

Keywords: alkaptonuria, nitisinone,ochronosis, homogentisic acid
study to determine safety, pharmacokinetics, pharmacodynamics of bay73-4506 in combination with mfolfox6 or folfiri

Conditions: Colorectal Neoplasms

Summary: this multi-center, open-label, non-randomized, non-placebo-controlled, phase i study will define the safety profile and tumor response profile of the multi-kinase inhibitor bay73-4506 as oral treatment in combination with the chemotherapy regimen mfolfox6 or folfiri in patients with metastatic crc. it will also determine the impact of the combined administration on the concentration of drugs over time (pharmacokinetics) of bay73-4506, oxaliplatin, 5 fu, and irinotecan. this study will be conducted at approximately 5 - 8 study centers in germany. up to 60 patients will be enrolled into this study to ensute that at least 12 - 15 patients for each combination regimen can be evaluated for safety and pharmacokinetics. for this reason a minimum of 20 patients will receive mfolfox6 in combination with bay73-4506 and at least 20 patients will receive folfiri in combination with bay73-4506.


Eligibility criteria:
inclusion criteria: * histological or cytological documentation of adenocarcinoma of the colon or rectum. * at least 1 measurable lesion as per recist * ecog performance status of 0 - 1 * life expectancy of at least 12 weeks. * adequate bone marrow, liver, and renal function exclusion criteria: * more than 1 previous chemotherapy for colorectal cancer. adjuvant chemotherapy for colorectal cancer (stage i, ii, ii) is permitted, if the adjuvant therapy ended \>6 month before screening. * previous folfox treatment for patients who will be included in the mfolfox6 cohort apart from folfox treatment in an adjuvant setting. * previous folfiri treatment for patients who will be included in the folfiri cohort.

Keywords: colorectal cancer targeted therapy multi-kinase inhibitor folfox folfiri
pedometers and walking tests for pulmonary hypertension patients

Conditions: Hypertension, Pulmonary

Summary: concordance between walking tests and pedometer data may seem like a logical outcome for pulmonary hypertension (ph) patients. however, many individuals have discordant results: results much worse or better during an in-hospital walking test as compared to real life activity. the primary objective of this study is: to determine variables associated with discordance between the distance walked during an in-hospital 6-minute walking test (6mwt) and the average distance travelled per day (observed over a period of 28 days (2 × 14 days) using a pedometer) among ph patients.

secondarily, the discordance between 6mwt results versus total pedometer recorded distance and versus maximum daily pedometer-recorded distance will be similarly studied. the aim of the study is also to search for variables associated with progression free survival. the relationships between pedometer data and self-reported dyspnea variation will be studied. factorial analysis may be used to study the overall view of variable correlations and patient similarity/dissimilarity.

Eligibility criteria:
inclusion criteria: * patient with idiopathic pulmonary hypertension (ph), familial ph, or ph associated with various pathologies (groups i to iv of the international classification) * new york heart association (nyha) severity classes ii to iv * incident cases, or prevalent cases with stable disease over the last 3 months * collection of informed written consent * affiliation with or beneficiary of a social security program (health insurance) * outpatient consulting at the hospital on the day of inclusion * 6 minute walking test on day of inclusion exclusion criteria: * patients protected or unable to give consent according to article l1121-8 of the french public health code (csp) * pregnant or lactating women according to article l1121-5 of the csp * vulnerable persons according to article l1121-6 of the csp * simultaneous participation in any other research protocol * it is impossible to correctly inform the patient (language barrier, etc.) * the patient has already been included in the study

Keywords: health related quality of life anxiety depression coping fatigue
cross-sectoral rehabilitation after stroke (cres)

Conditions: Stroke; Neurological Rehabilitation; Patient Involvement

Summary: prospective cohort study during post stroke rehabilitation in hospital and municipality. participants will be measured with accelerometers, tests in relation to physical function and qualitative interviews.

during and after hospitalization, patients with stroke are subjected to early rehabilitation starting at the hospital stay and continuing after discharge to a municipality. however, the continuity and adherence across sectors is challenged by different locations for the rehabilitation and time gaps from discharge to start in municipality. this project focuses on the physical activity of patients with stroke measured with 3d accelerometry, the physical performance of the patients measured using the 30 second chair stand test, balance measured with bergs balance scale and health-related quality of life (hrqol) measured with the 5-level version of european quality of life (eq5d-5l). furthermore, the patient perspectives and experiences with the rehabilitation plans are explored in semi-structured interviews at the end of the project. the municipalities in nordsjælland have been informed regarding the project and all their approvals have been collected prior to expected start in fall 2022. the heads of rehabilitation in the municipalities have approved participation in the research project with regards to follow-up of patients. the municipalities will support the data collection process with a therapist from each municipality working with quality control of the rehabilitation.

Eligibility criteria:
inclusion criteria: * 18 years of age; * hospitalized at nordsjællands hospital (noh) with acute stroke; * discharged from the department of neurology noh with a general rehabilitation plan to one of the eight surrounding municipalities (hillerød, allerød, gribskov, helsingør, hørsholm, halsnæs, frederikssund fredensborg); * able to give written informed consent; exclusion criteria: * poor danish language skill; * patients refusing any rehabilitation or medically assessed as inevitably dying within 12 weeks;
colonoscope insertion trial protocol

Conditions: Colorectal Cancer

Summary: this research study is about determining how well a technically improved colonoscope from olympus works in helping the doctor in guiding the scope through the large bowel or colon. when a doctor performs a colonoscopy he guides or inserts the scope from the rectum to the appendix where the small bowel ends and the large bowel begins. there are points during this insertion where there are turns in the colon which can create a loop in the colonoscope. these loops can stretch the colon and create some discomfort and also require special maneuvers by the nurse or patient to help reduce or minimize the loop. thus, reducing the looping will make it more comfortable for the patient and more efficient for screening for polyps. the purpose of the study is to examine this colonoscope and compare it to the traditional adult colonoscope (olympus cf-h180). the investigators hypothesis is that this colonoscope will function better with regard to insertion of the scope from the rectum to the cecum.

there will be two arms to the study, the cf-h180 adult colonoscope (control arm) and the olympus technically improved colonoscope (olympus). (control arm). in this protocol the investigators will randomize patients to either the adult colonoscope or to the olympus technically improved colonoscope (olympus) arm. the name of the arm (cf-h180 adult colonoscope or technically improved colonoscope) will be in a sealed envelope and opened by the nurse. the endoscopist will be blinded to the scope that will be used.

Eligibility criteria:
inclusion criteria: * patients presenting for outpatient colonoscopy between the ages of 35 and 75 years of age * the patient population will be open. however, it is known that thin female patients (bmi \< 25) and/or past history of diverticular disease and/or gynecological surgery and men \& women who are tall (6'+) and patients with constipation are usually difficult candidates for a complete colonoscopy (retroflex in the cecum) * adequate bowel preparation * the ability to provide informed consent exclusion criteria: * women that are pregnant * patients with a past history of inflammatory bowel disease * patients with a past history of surgical resection (hemicolectomies, etc)

Keywords: colonoscopy
oral care and gram-negative pathogen in children

Conditions: Tracheal and Oropharyngeal Colonization by Gram-negative Pathogens

Summary: critical care nursing interventions related to oral care can reduce the microorganisms in the oropharynx available for translocation to other sites. this is a randomized, controlled and double blinded study performed in a pediatric intensive care unit (picu) from a brazilian university hospital which objectives were to analyze 0.12% chlorhexidine digluconate influence on gram-negative pathogens colonization of oropharyngeal and tracheal secretions of mechanically ventilated children.


Eligibility criteria:
inclusion criteria: * all the picu children during 24 months of study were selected for participation. exclusion criteria: * newborns, those that fulfilled the centers for disease control and prevention criteria for pneumonia in infants and children at the time of picu admission, picu los less than 48 hours, presence of tracheostomy and those that declined to participate.

Keywords: oral hygiene ventilator-associated pneumonia infection control intensive care pediatric nursing pediatrics
effect of the exercise-meal timing on energy intake and appetite in adolescents with obesity

Conditions: Pediatric obésity

Summary: the aim of the present study is to compare the effect of realizing an exercise right before or right after a meal of on energy intake, appetite feelings and food reward in adolescents with obesity.

the present study will compare the nutritional response to the realisation of an acute exercise right before or right after lunch in adolescents with obesity. 18 adolescents with obesity will be asked to randomly complete three experimental sessions: i) one control session (rest); ii) one session with an acute exercise realized right before lunch; iii) one session with an acute exercise realized right after lunch. their ad libitum energy intake will be assessed during lunch as well as at dinner time. appetite feelings will be assessed at regular intervals and their food reward in response to the lunch will also be assessed.

Eligibility criteria:
inclusion criteria: * bmi percentile \> 97th percentile according to the french curves. * ages 12-16 years old * signed consent form * being registered in the national social security system * no contraindication to physical activity exclusion criteria: * previous surgical interventions that is considered as non-compatible with the study. * diabetes * weight loss during the last 6 months * cardiovascular disease or risks

Keywords: appetite control obesity adolescents exercise timing