Kornimate/medical-research-clean huggingface dataset:
changes in plasma amino acid appearance after adding bacillus coagulans gbi-30, 6086 to milk protein concentrate

Conditions: Protein Malabsorption

Summary: the purpose of this study is to examine the pattern of plasma amino acid appearance after a two-week daily regimen of milk protein concentrate supplementation with and without the addition of bacillus coagulans gbi-30, 6086 among older women.

once determined eligible and providing consent, participants will be assigned in a randomized, double-blind, crossover fashion to ingest a single daily 25-gram dose of a milk protein concentrate or a similar dose of milk protein concentrate plus bacillus coagulans gbi-30, 6086. upon arrival for each study visit, participants will have their resting heart rate, blood pressure, body mass, height, and body composition measured. upon ingestion of their final assigned supplementation dose, standard multiple sample phlebotomy approaches will be used to collect approximately 10ml of venous blood from a forearm vein at specific time intervals up to four hours after ingestion of their final assigned supplementation dose for that period in the study protocol.

Eligibility criteria:
inclusion criteria: * all participants will be between the ages of 50-70 years * completing at least 30 minutes of physical activity at minimum three days per week exclusion criteria: * as indicated on a medical history form they complete, any individual who is currently being treated for or diagnosed with a cardiac, respiratory, circulatory, musculoskeletal, metabolic, obesity (defined as body mass index \> 30 kg/m2), immune, autoimmune, psychiatric, hematological, neurological or endocrinological disorder or disease * any woman who is taking a medication known to impact digestive function or hormonal functions that may impact how our body digests, absorbs, or metabolizes nutrients * any woman currently taking a probiotic or a dietary supplement that may impact digestive function or hormonal functions that may impact how our body digests, absorbs, or metabolizes nutrients * participants who are determined to not be weight stable defined as measured body mass deviating by 2% or more. * participants who do not or are not willing to abstain from alcohol, nicotine, and caffeine for overnight (8-10 hours) * participants who do not or are not willing to abstain from exercise for 24 hours prior to each visit * women who are pregnant * women who are lactose intolerant
short-term function and pain after treatment for dupuytren's disease

Conditions: Dupuytren Disease

Summary: this study will evaluate short-term pain and function associated with percutaneous needle aponeurotomy (pna) and injections of the enzyme collagenase clostridium histolyticum in patients with dupuytren's disease. scores on outcome measures will be compared between groups to determine whether treatments differ in terms of hand function and pain during the early post-treatment period.

percutaneous needle aponeurotomy (pna) and injections of the enzyme collagenase clostridium histolyticum are two non-invasive treatment options for patients with dupuytren's disease. while pna has been offered for decades, injectable collagenase is relatively new. the effectiveness of each treatment has been compared in the literature; however, recovery, in terms of pain and short-term function has not been formally evaluated. the objective of this study is to objectively compare short-term function and pain outcomes associated with each of these two procedures in patients presenting with untreated dupuytren's disease.

Eligibility criteria:
inclusion criteria: * adult * dupuytren's disease diagnosis * consented to either percutaneous needle aponeurotomy or xiaflex injection (patient choice) * able to read/write/speak english * must have an email address exclusion criteria: * previous treatment for dupuytren's disease * type 2 diabetes mellitus * pre-existing hand condition, previous hand surgery or trauma

Keywords: dupuytren disease needle aponeurotomy collagenase
efficacy safety score in postoperative management

Conditions: Pain, Postoperative; Postoperative Nausea and Vomiting

Summary: the primary aim of this project is to determine whether postoperative patients may benefit from the efficacy safety score (ess) as a tool for postoperative clinical decision support, with a special focus on the first 24 hours after discharge from the postoperative care unit.


Eligibility criteria:
inclusion criteria: * undergoing surgery * expectedly to be treated and observed in hospital for more than 24 hours postoperatively exclusion criteria: * refusal of participation * poor communication capabilities

Keywords: patient safety postoperative care monitoring, physiologic safety management
a study of guselkumab and risankizumab in healthy participants and participants with psoriatic arthritis

Conditions: Arthritis, Psoriatic; Healthy

Summary: the purpose of this study is to assess the tissue distribution of guselkumab and risankizumab in healthy participants (part 1) and psoriatic arthritis (psa) participants (part 2 and part 3).


Eligibility criteria:
inclusion criteria: part 1: * healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ecg) performed at screening. any abnormalities, must be considered not clinically significant and this determination must be recorded in the participant's source documents and initialed by the investigator * has a negative severe acute respiratory syndrome coronavirus 2 (sars-cov-2) (coronavirus disease 2019 \[covid-19\]) reverse transcription polymerase chain reaction (rt-pcr) test within 72 hours prior to study intervention administration * body weight within 50 kilograms (kg) to 100 kg and body mass index (bmi) within the range 18 kilograms per meter square (kg/m\^2) to 30 kg/m\^2 (inclusive) parts 2 and 3: * have a diagnosis of psoriatic arthritis (psa) for at least 3 months before the first administration of study agent and meet classification criteria for psoriatic arthritis (caspar) at screening * have active plaque psoriasis exclusion criteria: part 1: * history or current signs and symptoms of liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, genitourinary, or metabolic disturbances * had major illness or surgery (example, requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from illness or surgery, or has surgery planned during the time the participant is expected to participate in the study or within 21 weeks after the last dose of study intervention administration parts 2 and 3: * history or current signs and symptoms of severe, progressive, or uncontrolled liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic (with the exception of psa), psychiatric, genitourinary, or metabolic disturbances * a nonplaque form of psoriasis (example, erythrodermic, guttate, or pustular)
kidney sodium functional imaging

Conditions: Chronic Kidney Disease; Nephrolithiasis; ADPKD

Summary: the corticomedullary gradient is largely responsible for developing the gradients that are needed to concentrate urine (more solutes and less water). the ability of the kidneys to produce concentrated urine is a major determinant of the ability to survive the warm weather. when temperatures are high, we lose water through sweat, and so the kidneys retain water to maintain fluidity in the blood. the maintenance of a sodium (salt) gradient is required for urine concentration because increased medullary sodium concentration increases the reabsorption of water into the kidney, to be redistributed in the blood. the purpose of this study is to know if the corticomedullary gradient is altered in patients across a wide spectrum of kidney disease using sodium magnetic resonance imaging (mri), a machine that takes pictures and measures the salt content in the kidneys. 23na kidney mri, will provide functional mr of the kidney as a non-invasive tool to describe medullary function to improve management of chronic and kidney disease.

this study is a pilot exploratory study (preliminary project to assess the use of a kidney sodium coil across a wide spectrum of kidney disease). approximately 200 patients from the london health sciences regional renal program will be recruited. this study involves two visits at robarts research institute or st. joseph's hospital, london, ontario depending on scanner availability, lasting approximately 2 hours. at the first study visit participants will undergo a sodium mri scan of your kidneys. prior to the scan, participants will have their sitting blood pressure and heart rate measured three times consecutively using a standard automatic blood pressure monitor. in addition to this, participants will be asked to provide a spot urine sample and have blood work done. if participants have been treated for nephrolithiasis, they will be responsible for completing a 24-hour urine volume test sometime the week before the mri scan.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * for healthy controls: lack of kidney disease, heart failure, liver cirrhosis and peripheral edema * for ckd stage 1-5: estimated gfr \< 90 ml/min/1.73m² * for patients on maintenance hemodialysis or peritoneal dialysis: more than 3 months duration of therapy exclusion criteria: * pregnant, breastfeeding or intending pregnancy * contraindication to mri * inability to tolerate mri due to patient size and/or known history of claustrophobia. * mechanically implanted, electrically, or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, tattoos, shunt, surgical staples (including clips or metallic sutures and/or ear implants.)

Keywords: cortico-medullary gradient
surgical italian guide for the management of complicated acute diverticulitis emergency setting (sigma-d). a prospective observational multicenter study on behalf of the italian society of colorectal surgery (siccr).

Conditions: Acute Diverticulitis; Stoma Colostomy; Stoma Ileostomy

Summary: this study will include data collected from surgical units performing emergency surgery in italy during 2024, with a one-year follow-up period for each patient. data for each center will be prospectively collected through a database filled out by the italian society of colorectal surgery (siccr) members who participate to the study. specific data will include: wses diverticulitis classification, procedure timing, laparoscopic/converted procedures, rate of performed protection ileostomies or colostomies, rate and timing of hartmann reversal or stoma closure, procedures with more than two operators, procedures with expert first operator, night or weekend procedures, and patients aged over 80. postoperative data will focus on complication rates and mortality at one, six, and twelve months.


Eligibility criteria:
inclusion criteria: * 18 yo or older * ct scan and wses classification * surgical intervention within 48 hours for acute diverticulitis exclusion criteria: * underaged * conservative treatment for acute diverticulitis * other treatment * diagnosis of colorectal cancer at histology
pro-active monitoring of vital signs in oncology patients using a smartwatch

Conditions: Cancer; Emergencies

Summary: the goal of this single center prospective observational study is to determine the effect of chemotherapy on (the change in) vital parameters. the main question it aims to answer are: can changes in vital parameters be measured by using a fitbit in patients with cancer while undergoing chemotherapy. participants will be asked to wear a fitbit for the first two cycles of chemotherapy to evaluate the changes in vital parameters.

the goal of this single center prospective observational study is to determine the effect of chemotherapy on (the change in) vital parameters. the main question it aims to answer are: can changes in vital parameters be measured by using a fitbit in patients with cancer while undergoing chemotherapy. participants will be asked to wear a fitbit for the first two cycles of chemotherapy to evaluate the changes in vital parameters. patients will start measuring in the week prior to the first cycle of chemotherapy, target is at least 4 to 7 days before initiation of chemotherapy. patients were the fitbit as much as possible, during day and night. patients continuously carry the fitbit during the first 3 months of systemic treatment, which tracks their vital signs. at the starting day of the next cycle of chemotherapy patients will have an appointment with one of the researchers to evaluate the use of the fitbit. furthermore, it will be checked if a patient has returned to their baseline vital signs.

Eligibility criteria:
inclusion criteria: * age ≥18 years; * diagnosis of stomach or esophageal cancer with an indication of starting chemotherapy * knowledge how to handle a fitbit * mastery of dutch language * able and willing to give written informed consent exclusion criteria: * cognitive disorders or severe emotional instability * already participating in an exercise trial

Keywords: cancer monitoring fitbit
pravastatin efficacy and safety trial in hypercholesterolemic patients with chronic liver disease

Conditions: Hypercholesterolemia

Summary: to determine in hypercholesterolemic subjects with chronic, well-compensated liver disease, the percent change from baseline to week 12 in serum ldl-c of pravastatin 80 mg compared to placebo.


Eligibility criteria:
inclusion criteria: * chronic, well-compensated stable liver * hypercholesterolemia exclusion criteria: * signs or symptoms of ascites, jaundice, or cirrhosis with a child-pugh score \> 5 * history of disorders affecting serum bilirubin levels, more than 1 chronic liver disease, significant endocrine, renal, or gastrointestinal disease, or uncontrolled hypertension * treatment with lipid-lowering drugs, unless they have been withdrawn within the timeframe specified in the protocol
comparison of epidural oxycodone and epidural morphine

Conditions: Pruritus

Summary: the primary objectives of this study are to compare the efficacy of pain relief between epidural oxycodone and epidural morphine for postoperative analgesia after elective caesarean section and to compare the incidence and severity of pruritus. secondary objectives are to compare other side effects of epidural administered oxycodone and morphine (nausea and vomiting, sedation, respiratory depression) and to investigate the safety and efficacy of epidural oxycodone and epidural morphine after use for postoperative analgesia in caesarean sections.

undesirable side effects such as pruritus and nausea are common with epidural morphine and are thought to be due to mu-opioid receptor stimulation at the supra-spinal level. recent studies of epidural oxycodone for abdominal and gynaecological surgery have shown that it is as effective as morphine with fewer side effects by this route. this has not been established in patients undergoing caesarean section. oxycodone is a semi-synthetic opioid derivative that resembles morphine structurally and has similar lipid solubility. it has been reported that the analgesic action of oxycodone is more rapid in onset when compared with morphine and is mediated by kappa-opioid receptors in the spinal cord. the significance of our study would be to establish that epidural oxycodone reduces the side effects of pruritus of epidural morphine whilst still maintaining similar analgesia.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) physical status 1-2, * aged between 21 to 50 years undergoing a term elective caesarean section and * had consented for combined spinal-epidural (cse) anaesthesia exclusion criteria: * concurrent opioid therapy, * contraindications to cse anaesthesia or any of the study medications, * a history of pre-existing nausea and vomiting, * failure to identify intrathecal space at time of anaesthesia, * inadvertent dural puncture with the epidural needle and * conversion of regional anaesthesia to general anaesthesia

Keywords: pruritus
efficacy of pico single-use system in chronic ulcers

Conditions: Chronic Ulcer; Venous Ulcer; Diabetic Foot Ulcer; Pressure Injury

Summary: a clinical trial will be carried out comparing the efficacy of pico system based on negative pressure therapy (npt) in adults with chronic ulcers compared to conventional treatments.

due to the current scientific and clinical evidence shows that npt offers guarantees as complementary care, improving healing and reducing amputations in patients with chronic ulcers, treatment with pico single-use npt, should be considered as the first option. this clinical trial include adults from the hospital general universitario of toledo with 2 arms (intervention and control) and the intervention will last 12 weeks. the intervention proposed in the study will consist of evaluating the decrease in size, the healing rate, the adverse effects and the quality of life related to the health of the patients compared with traditional treatments.

Eligibility criteria:
inclusion criteria: * both sexes over 18 years. * patients with chronic ulcers: venous leg ulcer, diabetic foot ulcer or pressure ulcers. * patients capable of complying with the protocol instructions and signing the informed consent (ic) or with limited capacity to act, in which case their relatives would be informed, who would be the ones who would grant the signed informed consent. * acceptable state of health. exclusion criteria: * malignant ulcers. * ulcers with abundant exudate. * non-modifiable anatomical location to create hermetic seal of the dressing. * suspected or known allergy to components of tpn systems. * pregnancy. * serious cardiovascular diseases. * diagnosis of vasculitis or claudication. * current administration of systemic chemotherapy or corticosteroids. * having received prior treatment with tpn or hyperbaric oxygen in the 7 days prior to screening. * leukopenia, thrombocytopenia, anemia, increased bilirubin or three times the level of liver enzymes. * deep venous thrombosis. * refusal or inability to tolerate compression therapy, exposure of muscles, tendons or bone. * diagnosis of active charcot foot syndrome. * malnutrition or eating disorders.

Keywords: negative pressure therapy chronic wound ulcer conventional treatment
pilot study to evaluate actimyo measured activity in parkinson disease patients & healthy volunteers

Conditions: Parkinson Disease; Healthy Volunteers

Summary: pre-quantipark is a pilot study to evaluate the reliability and responsiveness of actimyo measured activity in pd patients. the purpose of the study is to provide validation of the actimyo, an innovative home-recording device enabling use in clinical trials and as an innovative tool for pd patient care.


Eligibility criteria:
patients: inclusion criteria * clinical diagnosis of idiopathic pd (ukpdsbb criteria) * on stable parkinsonian medication regimen including levodopa for at least 4 weeks * male of female aged ≥18 years old * experiencing motor fluctuations and dyskinesia * moca (montreal cognitive assessment) ≥ 26 * willing to adhere and comply to the protocol requirements as evi-dence by written informed consent * capable and willing to accurately using actimyo * capable and willing to complete diaries * unlimited broadband internet access at home * agrees to be filmed * affiliated to or a beneficiary of a social security scheme * pd patients subgroup #1 only: levodopa acute test scheduled as part of usual care exclusion criteria * undergone surgery for the treatment of pd * apomorphine or levodopa pump in place * deep brain stimulation or transcranial magnetic stimulation * drug-induced parkinsonism * vascular parkinsonism * parkinson plus syndromes (such as multiple system atrophy, pro-gressive supranuclear palsy, and corticobasal degeneration) * other neurodegenerative disorders * any other significant medical or psychiatric illness that could inter-fere with study evaluation * for women: pregnancy or current breastfeeding * under legal protection healthy subjects: inclusion criteria * male of female matched by age with pd patients ; aged ≥ 18 * willing to adhere and comply to the protocol requirements as evi-dence by written informed consent * capable and willing to accurately using actimyo * capable and willing to complete diaries * moca (montreal cognitive assessment) ≥ 26 * unlimited broadband internet access at home * agrees to be filmed * affiliated to or a beneficiary of a social security scheme exclusion criteria * any significant medical or psychiatric illness that could interfere with study evaluation * for women: pregnancy or current breastfeeding * under legal protection * close or near relation of investigators, institute of myology employ-ees, or afm-telethon members.
a comparison of once a day dose compared to 2 doses/day

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to compare the efficacy in maintaining remission of ulcerative colitis between a once daily (qd) asacol regimen and a divided, twice daily (bid) asacol dosing regimen.

currently, in the us, asacol therapy is indicated in divided doses for the maintenance of remission of ulcerative colitis at 1.6 g/day. a once daily dose is potentially beneficial to patients and physicians alike. this study will answer the following questions about once daily dosing: (1) does efficacy differ between once daily and twice daily dosing, (2) do patients prefer a once daily dosing regimen, and (3) is compliance better? this study will confirm whether there are benefits to once daily dosing beyond increased convenience. in order to understand how the qd regimen compares to bid in a "real life" practice setting, the patient will remain on the total daily dose of asacol (1.6 g/day to 2.4 g/day) on which they were maintained in remission, but will be assigned to either a qd or bid regimen. this is an investigator-blinded study.

Eligibility criteria:
inclusion criteria: * documented history of ulcerative colitis that has been successfully maintained in remission for at least 3 months prior to study entry * at least one flare in the past 18 months * utilizing a stable maintenance dose of oral asacol of 1.6 g/day up to 2.4 g/day (stable dose is defined as the same dose for the past 3 months) * females must be postmenopausal or surgically sterile or have a negative urine pregnancy test and practice acceptable contraception exclusion criteria: * history of or current renal disease * history of hepatic disease * history of allergy or hypersensitivity to salicylates, aminosalicylates * treatment with immunomodulatory therapy, biologic therapy or corticosteroids within 90 days of screening * received any antidiarrheals, antispasmodics, or antibiotic within 1 month of screening