Kornimate/medical-research-clean huggingface dataset:
alternate day ultrahypofractionated or daily moderately hypofractionated post operative radiotherapy (ampora)

Conditions: Post-Operative Prostate Cancer

Summary: this is a multi-institution, randomized, non-inferiority phase ii trial comparing external beam radiotherapy delivered as 54 gy in 20 fractions to prostate bed +/- 44 gy in 20 fractions to pelvic lymph nodes delivered daily with external beam radiotherapy delivered as 30 gy in 5 fractions to prostate bed +/- 25 gy in 5 fractions to pelvic lymph nodes delivered on alternate days.


Eligibility criteria:
inclusion criteria: 1. age \> 18 years 2. able to provide informed consent 3. histologic diagnosis of prostate adenocarcinoma 4. ecog performance status 0-1 5. previous radical prostatectomy \> 6 months prior to radiotherapy start date 6. planned to receive post-operative radiation exclusion criteria: 1. prior pelvic radiotherapy 2. contraindications to radiotherapy 3. mets confirmed as per (if scan has been done for clinical care) 4. participants with visible disease in the prostate bed or pelvic lymph nodes on imaging are not eligible for treatment on study.
evaluation of the efficacy of low level laser therapy in ulnar neuropathy at the elbow

Conditions: Ulnar Nerve Entrapment at Elbow

Summary: the purpose of this study is, to demonstrate the effectiveness of low-level laser therapy on symptoms, clinical and electrophysiological parameters in elbow ulnar neuropathy.

ulnar neuropathy of the elbow is the second most common entrapment neuropathy of the upper extremity. the ulnar nerve is prone to entrapment due to its anatomical location in the elbow. the most important cause of entrapment occurs as a result of frequent chronic mechanical compression or stretching. repetitive flexion-extension movement of the elbow increases the pressure in both the cubital tunnel and other potential entrapment sites, causing tension in the ulnar nerve and increased intraneural pressure. ulnar neuropathy of the elbow, a detailed history and a comprehensive physical examination are the essential first steps in making the correct diagnosis. in case of doubt, electrophysiological studies, in particular, play an important role in diagnosis by determining both the location of nerve compression and the severity of the disease. there are conservative and surgical methods for the treatment of ulnar neuropathy in the elbow. in most patients, especially in mild and moderate entrapments, conservative treatment is preferred instead of surgery as initial treatment. low-level laser therapy, one of the physical therapy modalities, creates photochemical reactions and biostimulation in the cells, interstitial tissue, vascular structure and immune system. its anti-inflammatory effect is through inhibition of cyclooxygenase-2 enzyme and a decrease in prostaglandin e2 levels, and its analgesic effect is by inhibiting nociceptive pathways in peripheral nerves, thus reducing pain. it has been shown to increase nerve regeneration and nerve conduction, reduce the effects of nerve compression, and may stimulate nerve healing thanks to its biophysical effect. there is no sham-controlled study showing the effectiveness of low-level laser therapy in elbow ulnar neuropathy, the second most common entrapment neuropathy. the study was planned to investigate the effectiveness of low-level laser treatment on symptoms, clinical and electrophysiological parameters in elbow ulnar neuropathy.

Eligibility criteria:
inclusion criteria: * ulnar neuropathy at the elbow evidenced by electrophysiological evaluation * symptoms onset with more than 1 months exclusion criteria: * presence of thenar, hypothenar or intrinsic muscle atrophy, * diabetes mellitus * hypothyroidism * receiving an electrophysiological diagnosis of carpal tunnel syndrome, cervical radiculopathy, brachial plexopathy, thoracic outlet syndrome * vascular disease * ulnar nerve injury or trauma, * malignancy, * having received treatment for ulnar neuropathy in the elbow within the last 3 months, * using nonsteroidal anti-inflammatory drugs (nsai) regularly

Keywords: low-lever laser therapy splint ulnar nerve entrapment at elbow electroneuromyography
a study to evaluate the efficacy and safety of vx-661 in combination with ivacaftor in subjects aged 12 years and older with cystic fibrosis, heterozygous for the f508del-cftr mutation

Conditions: Cystic Fibrosis

Summary: study to evaluate the efficacy of vx-661 in combination with ivacaftor (iva, vx-770) through week 12 in participants with cystic fibrosis (cf) who are heterozygous for the f508del mutation on the cf transmembrane conductance regulator (cftr) gene and with a second cftr mutation that is not likely to respond to vx-661 and/or iva therapy (f508del/not responsive \[nr\]).


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of cf defined as a sweat chloride value greater than or equal to (\>=)60 millimole per liter (mmol/l) by quantitative pilocarpine iontophoresis. * heterozygous for the f508del-cftr mutation and with a second cftr mutation that is not likely to respond to vx-661 and/or ivacaftor therapy, genotype to be confirmed via assessment at the screening visit. * forced expiratory volume in 1 second (fev1) \>=40 percent (%) and less than or equal to (\<=)90% of predicted normal for age, sex, and height at screening visit. exclusion criteria: * history of any comorbidity that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant. * an acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease within 28 days before day 1 (first dose of study drug). * history of solid organ or hematological transplantation. * ongoing or prior participation in an investigational drug study or use of commercially available cftr modulator within 30 days of screening. * pregnant or nursing females.
investigation of efficacy and outcome of a new medical device for treatment of migraine

Conditions: Migraine

Summary: the purpose of this study is to evaluate the efficacy of a novel therapy for treatment of migraine, pain reduction and relief of associated symptoms during ongoing migraine attacks, and presence of a preventive effect two months post treatment. another purpose is to investigate if and how this treatment affects manifestations of the autonomic nervous system activity.


Eligibility criteria:
inclusion criteria: * female or male subjects, in otherwise good health, 20 to 55 years of age * subjects who meet the ichd-2 (2nd edition of the international headache classification) criteria for migraine headache * subjects with a minimum of 1 migraine attack per month * attack duration of 4 to 72 hours * normal attack intensity of at least 4 on a 0-10 vas-scale exclusion criteria: * completed heart surgery * cardiovascular diseases * vascular damages on neck vessels * diseases other than migraine of the cns * severe disease of vital body organs * severe psychiatric disorders * more than 6 migraine attacks per month
metabolic syndrome observation on a regional basis

Conditions: Metabolic Syndrome

Summary: the aim of the study is to assess the prevalence of metabolic syndrome in italy on a regional basis, defined according to ncep/atpiii guidelines criteria.


Eligibility criteria:
inclusion criteria: * patient aged between 18 and 75 years * signed informed consent * laboratory analysis (lipidic profile and glycemia) performed in the last year exclusion criteria: * pregnancy or breast feeding * patients enrolled in clinical studies which the aim is to evaluate the efficacy and/or tolerability of anti-hypertensive and/or lipid lowering drugs * subjects with serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's successful participation in the study

Keywords: metabolic syndrome lipids waist circumference hdl hypertension
the effects of intensive insulin on somatic and visceral protein turnover in acute kidney injury (aki)

Conditions: Acute Renal Failure

Summary: we propose to determine the acute metabolic effects of intensive insulin therapy when administered to aki patients with a particular focus on its effects on protein metabolism. we hypothesize that the degree of insulin resistance correlates with protein catabolism in critically ill patients with aki, and that intensive insulin therapy will result in substantial reductions in both whole-body and skeletal muscle protein breakdown thereby improving overall protein balance. we also hypothesize that this therapy will have favorable effects on the inflammatory and oxidative stress profile of patients with aki. the metabolic response to these interventions will be assessed through stable isotope infusion techniques, allowing for the most precise assessment of protein and energy homeostasis.


Eligibility criteria:
inclusion criteria: * adults ≥ 18 years of age admitted to the intensive care unit * new onset acute kidney injury (aki) or aki superimposed on chronic kidney disease. aki will be defined as: * an abrupt (within 48 hours) sustained increase (\>24 hours) in serum creatinine of 2x baseline or * a reduction in urine output (documented oliguria of \ 12 hours) * patients will be recruited for the study within 3-5 days following establishment of aki exclusion criteria: * institutionalized patient * unable to obtain consent from subject or legally recognized representative * pregnancy * patients receiving insulin within 12 hours of the study or patients with known diabetes mellitus. * patients receiving immunosuppressive medication including steroids (prednisone or equivalent dose ≥ 5 mg po qd) * aki from urinary tract obstruction or a volume responsive pre-renal state. * liver failure, defined as transaminase levels 3 times above the limit of normal or a total bilirubin greater than 4 mg/dl. * evidence of active bleeding, defined as admission for bleeding (ex. gi bleed, ruptured aneurysm, trauma-related) coupled with an explained or unexplained decrease in hemoglobin of \>2 points in the past 24 hours, or hgb\<8/hct\<24 * ongoing myocardial ischemia or heart failure * life expectancy \< 48 hours * patients without existing central venous access * hemodynamically unstable patients requiring active pressor titration, defined as an increase in current pressor dose by \>20% or addition of a new pressor within 12 hours of initiating the study. * history of phenylketonuria (pku) or other documented inborn errors of metabolism * hypokalemia, defined as a serum potassium of \<3.0 mg/dl. * uncontrolled seizure disorder, defined as having seizure as a reason for admission, ongoing delirium tremens, or having had a seizure within 1 month of the study.
conbercept injection in treatment of severe proliferative diabetic retinopathy

Conditions: Proliferative Diabetic Retinopathy; Tractional Retinal Detachment

Summary: to evaluate efficacy of different intravitreal conbercept injection therapy in the treatment of severe proliferative diabetic retinopathy.

to assess the clinical effects of preoperative, intraoperative or preoperative combined with intraoperative intravitreal conbercept (ivc) injection in pars plana vitrectomy (ppv) with silicone oil tamponade for severe proliferative diabetic retinopathy (pdr). methods. these patients were randomly assigned to three groups: group 1 received an ivc injection 3 to 5 days before surgery; group 2 received an ivc injection at the end of surgery; and group 3 received an ivc injection 3 to 5 days before ppv as well as an ivc injection at the end of ppv. follow-up examinations were performed for at least six months after surgery.

Eligibility criteria:
inclusion criteria: 1. subjects of either sex aged ≥ 18 years. 2. diagnosis of diabetes mellitus (type 1 or type 2); 3. active proliferative diabetic retinopathy was clinically evident; 4. study eyes required a vitrectomy and silicone oil tamponade due to vitreous hemorrhage with significant fibrous proliferation, tractional retinal detachment in the posterior pole or complicated retinal detachment, which can be detected by b-scan ultrasonography. 5. ability to give informed consent. exclusion criteria: 1. coexistent ocular disease that may interfere with visual outcome; 2. prior vitreoretinal surgery or anti-vascular endothelial growth factor (vegf) pharmacotherapy in either eye; 3. a macula-involving retinal detachment for \>6 months in the study eye; 4. iris or angle neovascularization and neovascular glaucoma; 5. known allergy to any components of conbercept formulation 6. severe external ocular infection; 7. pregnancy or current oral contraceptive intake; 8. usage of anticoagulant or antiplatelet therapy; 9. preoperative or postoperative poor diabetes control \[serum hemoglobin a1c (hba1c) \>11.0%\]; 10. uncontrolled systemic diseases, such as hypertension, cardiac diseases or presenting abnormal coagulation-associated blood diseases; 11. \<6 months of follow-up post initial surgery.

Keywords: conbercept proliferative diabetic retinopathy silicone oil tamponade
evaluation of phage therapy for the treatment of escherichia coli and pseudomonas aeruginosa wound infections in burned patients

Conditions: Wound Infection

Summary: the objective of phagoburn is to assess tolerance and efficacy of local bacteriophage treatment of e. coli or p. aeruginosa wound infections in burned patients.

phagoburn is a phase i/ii clinical trial randomized, multicentric, open label, standard of care (silver sulfadiazine) controlled aiming at assessing tolerance and efficacy of local bacteriophage treatment of wound infections due to e. coli or p. aeruginosa in burned patients using pherecydes pharma anti-escherichia coli and anti-pseudomonas aeruginosa bacteriophage cocktails gmp produced. this project is a european research \& development (r\&d) project funded by the european commission under the 7th framework programme for research and development. this project is involving 7 clinical sites in eu.

Eligibility criteria:
inclusion criteria: * man or woman * adult informed consent obtained from patient or next of kin * in-hospital patient treated for burn wounds in a burn unit * burn wound (grafted or not) or graft harvesting area, presenting local signs of infection defined by sfetb criteria: * a local or loco-regional inflammatory reaction; * and/or an adverse and unexpected local evolution; * and/or regarding burn wounds: presence of pus, fast spontaneous debridement and separation, occurrence of blackish spots (necrosis or haemorrhage), unexplained conversion from a superficial lesion to a deep one (\> 48th hour); * and/or regarding graft donor sites: presence of pus, unexplained delay in epidermisation, bedsore; * and/or regarding graft recipient sites: presence of pus, lysis of grafts, necrosis of fat located under the graft. * burn wounds with a microbiologically documented infection, as defined by positive surface swab, due to escherichia coli or pseudomonas aeruginosa whatever their resistance profile * treated by povidone-iodine exclusion criteria: * pregnant or breastfeeding woman * intercurrent condition requiring a treatment which may interfere with analysis results: such as high dose of chronic corticotherapy, immunosuppressive medication, oncologic chemotherapy * patient included in an interventional research protocol with therapeutic intervention still ongoing upon inclusion time or having participated into anti-infective drug trials during the previous month. * patient considered as part of a vulnerable population * patient for whom treatment limitation or withdrawal during study period is considered * allergy to silver sulfadiazine

Keywords: wound infection in burned patient
study of the clinical effect of external oblique muscle intercostal muscle plane block in abdominal surgery

Conditions: Nerve Block; Pain

Summary: this study intends to apply external oblique intercostal muscle plane block in thoracoabdominal resection, and to explore its effect on perioperative analgesia and rehabilitation quality in patients undergoing thoracoabdominal surgery.

approved by the hospital ethics committee, 60 patients undergoing thoracic and abdominal surgery were selected in this study. they were divided into experimental group (n=30) and control group (n=30). the experimental group was given 0.5% ropivacaine intercostal nerve block, 2.0ug/kg sufentanil and tropisetron 5mg intravenous analgesia, and the control group was given 2.0ug/kg sufentanil and tropisetron 5mg intravenous analgesia. map, hr and spo2 were recorded at admission (t0), completion of induction (t1), skin incision (t2), 30min after operation (t3) and 30min after extubation (t5). the block range of nerve block in the experimental group was recorded. the vas score and the number of patient-controlled analgesia pump were recorded 30min after extubation, 6h, 24h and 48h after operation in resting state and cough state. postoperative adverse reactions such as respiratory depression, expectoration weakness, nausea, vomiting, and skin itching were recorded. the first time to get out of bed after operation was recorded.

Eligibility criteria:
inclusion criteria: * asa physical status classification of i-ii aged 18-60 years old ; will be scheduled to undergo elective lc exclusion criteria: * coagulation disorders, liver/kidney disease, abdominal surgery history, infection in the block application area, chronic opioid use.
associations between self-reported sleep duration and sarcopenia in community-dwelling older adults

Conditions: Community-Based Participatory Research; Aged; Sleep; Body Composition

Summary: 1. backgrounds: currently, elderly people comprise more than 10% of the total taiwanese population. however, within the context of self-reported sleep duration and health risks, research into the association between sleep duration and body composition changes in older people is limited. it is important to gain an understanding of such an association of older people to estimate the public health burden. 2. objectives: to assess the association between self-reported sleep duration and sarcopenia as well as obesity in community-dwelling older adults. 3. hypothesis: self-reported sleep duration is associated with prevalence of sarcopenia and obesity in community-dwelling older adults. 4. design: a cross-sectional investigation. 5. setting: communities in zhongzheng district, taipei. 6. participants: four hundred and forty-eight community-dwelling adults (224 men and 264 women) aged 65 years and older. 7. measurements: the investigators evaluated self-reported sleep duration by deriving from the pittsburgh sleep quality index and 7-d recall physical activity diary. skeletal muscle mass was estimated by the predicted equation from a bioelectrical impedance analysis measurement. the groningen activity restriction scale and the chinese geriatric depression screening scale were used to evaluate physical disability and depression, respectively.


Eligibility criteria:
1. hyper- or hypothyroidism. 2. taking prescribed medications (such as growth hormone, testosterone, or progesterone) known to alter body composition. 3. any condition that prevented them from completing our questionnaires or the functional capacity test (e.g., amputee, nonambulatory even with the use of a walker or a cane, blind, or deaf).

Keywords: sarcopenia sleep duration body composition skeletal muscle
immediate parent -infant skin-to-skin study (ipistoss)

Conditions: Prematurity

Summary: the world health organization recommend all stable low birth weight neonates to have skin-to-skin-contact (ssc) after birth. intermittent ssc is used in sweden in neonatal units. observations indicate that ssc makes neonates feel good. however, there is limited research done on ssc treatment on neonates born prior to week 33. the aim of this study is to investigate whether skin-to-skin-contact (ssc) leads to an improved physiological stabilization, altered epigenetic profile and improved longterm psychomotor outcome in neonates born in gestation age between week 28+0 - 32+6. this is a parallel, two-arm, multicentre, randomized controlled superiority trial. the two arms to be compared are a) immediate ssc with one parent/caregiver continous during the first 6 hours after birth and as much as possible during the first 72 hours, and b) conventional method of care during the same time.


Eligibility criteria:
inclusion criteria: * born in gestation week plus days 28+0 - 32+6. * born at maternity ward at study center * consent from parents/caregivers * parent or caregiver or substitute are available to start skin-to-skin contact during the first hour of life. exclusion criteria: * born outside the hospital * triplets or more * known malformation which will require immediate surgical action * on-going resuscitation or intensive medical care (mechanic ventilation or inotropy) after the first lifespan \* known congenital infection * parent/care giver can not communicate in swedish/norwegian or english * not suited for the study for other reasons (according to the principal investigator)

Keywords: ipistoss skin to skin ssc neonatal kangaroo mother care
transdiagnostic sleep and anxiety treatment

Conditions: Anxiety Disorders

Summary: background: anxiety and insomnia disorders are two of the most common and costly mental health conditions. these disorders are frequently comorbid, but current treatment approaches do not target both. to streamline treatment for these commonly comorbid conditions, a novel, computerized intervention was developed targeting a transdiagnostic factor, safety aids, which are cognitive or behavioral strategies individuals use to cope with distress associated with anxiety or insomnia, that paradoxically exacerbate symptoms. a randomized controlled trial was conducted to determine the acceptability and efficacy of this newly developed intervention. method: young adults (n = 61) with elevated anxiety and insomnia symptoms were randomized to receive the anxiety-insomnia intervention or a computerized control condition focused on general physical health behaviors. after the intervention, participants were followed up at one week and one month and completed self-report measures.


Eligibility criteria:
inclusion criteria: * 1 sd above the mean in anxiety and insomnia symptoms * interest in improving anxiety and sleep exclusion criteria: * participating in another clinical trial