Kornimate/medical-research-clean huggingface dataset:
psychosocial and patient education needs of prostate cancer patients selecting watchful waiting

Conditions: Localized Prostate Cancer

Summary: this study includes an interview with men who have selected "watchful waiting" or "active surveillance" for their localized prostate cancer, in lieu of active treatment (such as surgery or radiation). we hope to understand the educational and support needs of men on surveillance so that we can develop a new intervention that will improve quality of life for such men.

interviews are conducted over the telephone and require approximately 90 minutes to complete. men interviewed are compensated for their participation in the study.

Eligibility criteria:
inclusion criteria: * 1) male, * 2) 18 years or older, with biopsy-proven prostate cancer, * 3) diagnosed with localized disease within the last 24 months, * 4) have a telephone at the time of enrollment, * 5) have an address where they can receive study materials by mail (a street address or post office box), * 6) able to speak and understand english; * 7) have selected surveillance, rather than active treatment for his prostate cancer. exclusion criteria: * 1) female * 2) no diagnosis of localized prostate cancer * 3) completed or undergoing active treatment (e.g., surgery, radiotherapy, etc.) * 4) no phone or us mail address * 5) unwilling or unable to provide informed consent * 6) unable to speak and understand english
fibrin sealant in bilateral simultaneous total knee arthroplasty with focus on blood loss, pain, swelling and strength

Conditions: Blood Loss

Summary: the purpose of this study is to measure the effect of fibrin sealant on reducing blood loss, pain and swelling when operated for bilateral total knee arthroplasty. likewise the effect on range of movement (rom) and strength is examined.


Eligibility criteria:
inclusion criteria: * elective bilateral knee arthroplasty * must speak and understand danish * musk be able to gave oral and written consent. * females must be post-menopausal, and last menstruation must be minimum of one year ago. exclusion criteria: * alcohol or medicine abuse * treatment with opioids * allergy to local anaesthetics * allergy to active substances i fibrin sealant * age below 18

Keywords: prospective randomised double-blind study fibrin sealant bilateral simultaneous total knee arthroplasty blood loss postoperative pain complications
evolution of perceived stress in general practice residents during covid-19 sanitary crisis

Conditions: Stress

Summary: over the last several years, distress among healthcare professionals is well described, and general practice residents are also affected. because of covid-19 sanitary crisis, stress factors are increased, and that may cause anxiety, exhaustion, psychic distress, depression, addictions, or post traumatic stress.

this prospective non-interventional study aims to evaluate via two questionnaires the evolution of perceived stress in general practice residents of two centres in france, rouen and caen. the two questionnaires contain the perceived stress scale, as well as items regarding socio-demographic data and stress factors. the first questionnaire is to be distributed during the epidemic covid-19 wave and the second questionnaire at the end of the epidemic covid-19 wave.

Eligibility criteria:
inclusion criteria: * being a general practice resident in rouen or caen * participant informed and non-objection of him/her exclusion criteria: * being on maternity leave or not working during the period concerned with the questionnaires
randomized controlled trial for retractor sponge evaluation in laparoscopic colorectal surgery

Conditions: Colorectal Cancer; Surgery

Summary: to achieve an adequate visual working field during laparoscopic colorectal surgery without disturbance of the small intestine, patients are positioned in trendelenburg position. this position results in hemodynamic changes which may increase the risk of cardiopulmonary complications and prolonged hospital stay. recently, an intraoperative retractor sponge was introduced as alternative for the trendelenburg position during laparoscopic surgery.

objective: to study the impact of use of an intraoperative retractor sponge on duration of hospital stay and risk of perioperative complications in patients undergoing laparoscopic surgery for colorectal cancer. study design: randomized controlled trial, nested within a prospective cohort according to the 'cohort multiple randomized controlled trial' (cmrct) design (clinicaltrials.gov nct02070146). study population: patients with colorectal cancer who undergo laparoscopic sigmoid of rectal resection, and who have given informed consent to be offered experimental interventions within the prospective cohort. patient who require open surgery or patients with benign colorectal diseases are excluded for this study. intervention: intraoperative use of the retractor sponge versus usual care, i.e. the trendelenburg position. main study parameters/endpoints: the primary endpoint is hospital stay. secondary objectives are operation time, blood-loss, fluid balance, body temperature, oxygen therapy and postoperative complications. nature and extent of the burden and risks associated with participation, benefit and group relatedness: the study will be conducted according to the cohort multiple randomized controlled trial (cmrct) design. within the plcrc cohort, we will identify all patients who are eligible for the experimental intervention and who have given informed consent to be invited for future experimental interventions. from this sub cohort, we will randomly select a group of patients to whom we will offer surgery with use of the retractor sponge, which they can accept or decline. eligible patients from the sub cohort who were not randomly selected will undergo standard treatment, i.e. surgery in trendelenburg position. we do not expect adverse events in patients in the intervention arm.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed distal colon (sigmoid) or rectal cancer, 2. planned for elective laparoscopic colorectal surgery, 3. performance status who 0-2 4. broad consent for randomization within prospective data collection initiative on colorectal cancer (plcrc) cohort exclusion criteria: 1. patients planned for open colorectal surgery or emergency colorectal surgery 2. patients with inadequate understanding of the dutch language in speech and/or writing.
a single dose study of khk6640 in japanese patients with alzheimer's disease.

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of khk6640, given as a single dose in japanese patients with mild to moderate alzheimer's disease.


Eligibility criteria:
inclusion criteria: * patients with mild to moderate alzheimer's disease * body weight ≥ 40 kg and \< 100 kg * clinical dementia rating (cdr) score of 1 or 2 * mini mental state examination (mmse) score of ≥ 17 amd ≤ 26 exclusion criteria: * previous active treatment with an alzheimer's disease immunotherapy in an investigational study * use of another investigational drug within 4 months prior to the enrollment * subjects who meet national institute of neurological disorders and stroke/association internationale pour la recherche et l'enseignement en neurosciences (ninds/airen) criteria for vascular dementia * subjects with a history of presence of clinically significant seizures, brain trauma, transient ischemic attack, and/or cerebrovascular disease * subjects with a presence of a neurological condition that could be contributing to cognitive impairment above and beyond that caused by the subject's alzheimer's disease * subjects who have evidence of infection, tumor, or other clinically significant lesions that could indicate a dementia diagnosis other than alzheimer's disease

Keywords: khk6640 phase 1 japanese single dose alzheimer's disease
treatment of acromegaly with somatostatin analogs: gh vs. igf-i as primary biochemical target

Conditions: Acromegaly

Summary: treatment of acromegaly with somatostatin analogs (sa) is well-established and are primarily used after insufficient surgical intervention, but also as primary medical treatment in selected patients. evaluation of treatment control is based on monitoring blood levels of growth hormone (gh) and insulin-like growth factor-i (igf-i). however, evaluation of disease control during sa treatment is not always straightforward. it is usually based on normalization of igf-i and achievement of a certain gh level. in approximately 40% of patients discordant values of gh and igf-i levels are seen after treatment with sa, with normalized igf-i levels, despite elevated gh levels. the mechanism behind this observation is unknown, but it indicates that sa may affect this difference. the primary objective of this study is to investigate if disease control during sa treatment is best achieved by monitoring either gh or igf-i.


Eligibility criteria:
inclusion criteria: * written informed consent * age \> 18 years * capable and of age * diagnosed with acromegaly * sufficient treated for at least 6 months prior to enrollment exclusion criteria: * pregnancy or nursing * any disease that may compromise the ability to comply with the protocol, as assessed by the investigator

Keywords: acromegaly somatostatin analogs treatment
botulinum a toxin in patients with parkinson's disease

Conditions: Parkinson's Disease; Multiple System Atrophy; Detrusor Overactivity

Summary: the researchers investigated the effectiveness and safety of bont/a injected into the detrusor muscle in patients with pd and msa all of whom had detrusor muscle overactivity unresponsive to conventional medical therapy.

patients included will have overactive bladder symptoms refractory to medical therapy. other causes of overactive bladder symptoms including urogenital prolapse and recurrent urinary tract infections were excluded. none of the patients will be under anticoagulant therapy or drugs interfering with neuromuscular transmission. the study was approved by the local ethical committee and patients gave their informed consent. patients will be informed about the possible need for intermittent catheterization after bont/a treatment. as outcome measures we assessed clinical and urodynamic variables.

Eligibility criteria:
inclusion criteria: * patients with overactive bladder symptoms refractory to medical therapy. exclusion criteria: * other causes of overactive bladder symptoms including urogenital prolapse and recurrent urinary tract infections were excluded. * concomitant anticoagulant therapy or drugs interfering with neuromuscular transmission. * neuromuscular disease like lambert-eaton syndrome.

Keywords: botulinum a toxin parkinson's disease
free fatty acids: short exposure study

Conditions: Hypogeusia

Summary: this study will examine whether or not short, daily exposures change a person's ability to detect free fatty acids in a solution by its taste. repeated exposure should improve a person's ability to detect free fatty acids.

the possibility that humans can taste non-esterified fatty acids (nefa) - so-called fat taste - is a relatively new area of research. previous work suggests that subjects require an average of between two and three testing sessions of approximately an hour each before they can reliably detect nefa, and the average number of visits to get the lowest threshold is six. streamlining this process is of great interest to researchers who wish to test many people as quickly as possible. other taste qualities, including umami and sweet, have shown improvement in detection sensitivity in subjects that have undergone ten second exposures to these taste qualities for 10 days upon subsequent re-testing. we seek to determine if the same improvements can be seen with fat taste.

Eligibility criteria:
inclusion criteria: * good health * available for multiple testing visits exclusion criteria: * have participated in a fat taste study in the past 6 months

Keywords: taste fat taste threshold testing
teaching harm reduction in a hospital setting: a peer-led intervention

Conditions: Opioid Use Disorder; Harm Reduction

Summary: the purpose of the study is to develop an acceptable, feasible, and effective peer-led bundle of harm reduction services to be delivered in the hospital setting, called the thrive intervention. the main question it aims to answer is: will participants receiving the thrive intervention have a reduced risk of self-reported non-fatal overdoses or skin/soft tissue infections compared to participants receiving enhanced usual care? researchers will compare the thrive model to enhanced usual care to see if the thrive model helps participants reduce their number of self-reported non-fatal overdoses or skin/soft tissue infections. intervention participants will: * receive one in-person session from a peer support specialist while in the hospital * receive weekly text messages from the peer support specialist for a 12-week period * receive monthly, multiple-choice assessments via text message at month 1, 2, 3, 4, 5, and 6 * complete a baseline, 3-month, and 6-month assessment with research assistants enhanced usual care participants will: * receive a handout with harm reduction education and resources in their local area * receive monthly, multiple-choice assessments via text message at month 1, 2, 3, 4, 5, and 6 * complete a baseline, 3-month, and 6-month assessment with research assistants


Eligibility criteria:
inclusion criteria: * participants who are: a) admitted to university of pittsburgh medical center (upmc) shadyside hospital, upmc presbyterian-montefiore hospital, upmc mercy hospital for inpatient or observation status, or b) seen in the emergency department setting at upmc presbyterian-montefiore hospital and upmc mercy hospital. * participants must have a current diagnosis of opioid use disorder based on the diagnostic and statistical manual of mental disorders (dsm-5) diagnostic criteria. * participants must be at least 18 years of age on day of admission. * participants must be able to speak and read english. exclusion criteria: * participants diagnosed with dementia and/or cognitive impairments. * participants with acute psychiatric complications, such as schizophrenia with acute psychosis, acute mania, or suicidal ideation (which may impact the ability of a participant to consent and actively participate in treatment). * participants who are pregnant or lactating at onset of study. * participants who cannot read or speak english.

Keywords: opioid use disorder harm reduction peer support peer support specialists
cardiorenal effects of sglt2 inhibition in kidney transplant recipients

Conditions: Kidney Transplant; Complications; Diabetes Mellitus, Type 2

Summary: crest-kt is a single-center, double-blinded, randomized trial of empagliflozin therapy in 72 kidney transplant recipients with (n=36) and without type 2 diabetes (n=36). after evenly dividing patients by type 2 diabetes diagnosis, patients will be randomized 2:1 to empagliflozin 10mg versus placebo.

a screening visit will occur at which time an informed consent will be obtained, and eligibility determined. women of childbearing potential will have a serum pregnancy test performed. this will be followed by a baseline visit. a renal biopsy and a 3d echocardiogram will be performed. at the next visit randomization will be performed and the subjects will receive their study medication, either empagliflozin or a placebo. following the randomization visit the subject will return every 3 months (visits 2-7) for a total of 6 visits spanning 18 months. at each visit vital signs and weight will be taken. other procedures include labs drawn for hematology, basic chemistry, coagulation, glycated hemoglobin and serum insulin. a 3 d echocardiogram is repeated on visits 4 and 6. a renal biopsy is repeated on visit 3.

Eligibility criteria:
inclusion criteria: 1. equal to or greater than 12 months and up tp 60 months post kidney transplant 2. estimated glomerular filtration rate (egfr) equal to or greater than 30ml/min/1.73m squared at screening 3. standard immunosuppression, including calcineurin inhibitor, mycophenolate mofetil or sodium and a glucocorticoid 4. able to provide written consent - exclusion criteria: 1. type i diabetes 2. any other solid organ transplant 3. hemoglobin a1c greater than 12 % 4. sglt2i use at the time of enrollment 5. prior sglt2i allergy or intolerance 6. pregnant or nursing at the time of enrollment 7. history of antibody medicated rejection (amr) or a banff score greater than 2b for acute cellular rejection (acr) 8. active anticoagulant use other than aspirin 81 mg for primary prevention of cardiovascular disease 9. known positive donor-specific antibodies prior to enrollment 10. uncircumcised men 11. greater than 2 urinary tract infections (uti) over the 12 months prior to enrollment 12. any genital infections over the 12 months prior to enrollment -

Keywords: post operative kidney transplant
efficacy and safety of parecoxib vs. indomethacin in preventing post-ercp pancreatitis

Conditions: Pancreatitis, Acute; Cholangiopancreatography, Endoscopic Retrograde

Summary: this study aims to evaluate the efficacy and safety of parecoxib versus indomethacin in preventing post-endoscopic retrograde cholangiopancreatography (ercp) pancreatitis (pep). it is a single-center, prospective, randomized, controlled, exploratory trial. participants will be randomly assigned to receive either parecoxib or indomethacin as a preventive treatment. the primary endpoint is to compare the efficacy of the two drugs in reducing the incidence of pep. secondary endpoints include the incidence of moderate to severe pep and post-ercp-related adverse events. this study will systematically assess the efficacy and safety of both drugs, providing preliminary data for future larger confirmatory trials.


Eligibility criteria:
inclusion criteria: * age between 18 and 80 years. * patients scheduled to undergo ercp for conditions such as common bile duct stones, benign or malignant biliary strictures, cholangitis, suspected biliary tumors, unexplained jaundice, or pancreas divisum. exclusion criteria: * previous papillectomy. * previous endoscopic sphincterotomy (est) without planned pancreatic duct intervention. * simple biliary stent removal or replacement without planned pancreatic duct intervention. * biliary-duodenal fistula, post-biliary-duodenal anastomosis, or post-biliary-jejunal anastomosis. * malignant tumor of the pancreatic head. * currently or recently (within 1 week) suffering from acute pancreatitis. * current or recent (within 1 week) use of nsaids. * recent (within 2 weeks) or within 4 weeks prior to surgery, gastrointestinal bleeding or peptic ulcers. * history of significant adverse reactions to nsaids. * renal insufficiency (creatinine clearance \&lt; 30 ml/min). * moderate to severe hepatic impairment (child-pugh score ≥ 7). * severe cardiovascular or cerebrovascular disease. * patients with psychiatric disorders. * pregnant or breastfeeding patients. * patients without a rectum. * patients unwilling or unable to provide informed consent.

Keywords: parecoxib indomethacin post-ercp pancreatitis efficacy safety
hepatitis b antibody persistence and immune response to hepatitis b vaccine challenge in previously vaccinated children

Conditions: Hepatitis B

Summary: this study will evaluate the persistence of immunity to hepatitis b in healthy children aged 7 to 8 years, after previous vaccination with infanrix hexa™ in the first two years of life, and also their ability to mount an immune response to the challenge dose of engerix-b™ kinder.


Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that their parent(s)/legally acceptable representative(s) can and will comply with the requirements of the protocol. * a male or female 7 to 8 years of age at the time of enrolment. * subjects with documented evidence of previous vaccination with four consecutive doses of infanrix hexa™ as part of routine vaccination in germany: three doses of primary vaccination received by 9 months of age and one booster dose received between 11 and 18 months of age. * written informed consent obtained from the parents/legally acceptable representative(s) of the subject at the time of enrolment. * in addition to the informed consent that will be signed by the parent(s)/legally acceptable representative(s), written informed assent of the subject will be sought when the subject is judged able to understand by the investigator. * healthy subjects as established by medical history and clinical examination before entering into the study. exclusion criteria: * child in care * use of any investigational or non-registered product, other than the study vaccine, within 30 days preceding the dose of study vaccine, or planned use during the study period. * concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. * evidence of previous hepatitis b booster vaccination since administration of the fourth dose of infanrix hexa™ booster in the second year of life. * history of or intercurrent hepatitis b disease. * hepatitis b vaccination at birth. * planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before and ending 30 days after the hepatitis b vaccine challenge dose. * administration of immunoglobulins and/or any blood products within the three months preceding challenge dose or planned administration during the study period. * chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the challenge dose of hbv vaccine. * history of any reaction or hypersensitivity likely to be exacerbated by any component of the hepatitis b vaccine, or evidence of hypersensitivity after previous immunisation with a vaccine containing the hepatitis b component. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * acute disease and/or fever at the time of enrolment.

Keywords: immune response engerix-b™kinder persistence challenge dose
effect of addition of pyramidal exercise to intermittent fasting on dryness of eye in pre-diabetic psoriasis patients

Conditions: Psoriasis; PreDiabetes; Obesity; Dry Eye

Summary: insulin resistant psoriatic obese patients may complain problems of dryness of eye. intermittent fasting may improve dryness of eye, obesity, insulin resistance, and psoriasis. exercise, as applied in pyramidal form, if added to intermittent fasting may improve effect of intermittent fasting.

forty obese patients with dryness of eye, obesity, insulin resistance (prediabetes), and psoriasis (chronic plaque) will randomly distributed to group i (n =20 patients) or group ii (n=20). both groups will receive the intermittent fasting regimen consisted of eating ad libitum for five days and then will restrict calories ('fasting') for two days per week, for a duration of 12 weeks. on the fasting days, participants will be instructed to restrict their calories to a maximum of 600 kcal/day for females and 650 kcal/day for males. the intermittent fasting intervention will consist of a dietary intervention based on the 5:2 fasting diet. subjects will be asked to consume a total of allowed calories in a window of 6 hours or less from 8:00 am till 2:00 pm, twice per week on 2 non-consecutive days. group i will receive a pyramidal training will be adopted for nearly 60 minutes (nearly two rounds of 21 minutes of running on electronic treadmill will be separated with 10 minutes of rest between the two rounds. also, warming (4 minutes before start of pyrimidal trianing) and cooling (4 minutes after pyramidal training) will be done through gentle stretching exercises/activities. the exercise will be applied 3 times weekly for 2 weeks

Eligibility criteria:
inclusion criteria: * chronic plaque psoriasis * obesity class i * prediabetic persons * dryness of both eyes exclusion criteria: * cardiac insults * respiratory insults * diabetics hypertensives or renal, hepatic insults