Kornimate/medical-research-clean huggingface dataset:
combined fdg pet/ct imaging in response evaluation after radiochemotherapy in patients with locally advanced head and neck squamous cell carcinoma (hnscc)

Conditions: Locally Advanced Squamous Cell Carcinoma of the Head and Neck Region

Summary: to determine if combined \[18f\]fluoro-2-deoxy-d-glucose (fdg) positron emission tomography/computed tomography (pet/ct) is performant enough with respect to detecting residual lymph node involvement after chemoradiation in order to omit planned neck dissections in patients with locally advanced potentially operable, n2 and n3 head and neck squamous cell carcinoma (hnscc). primary study hypothesis: the lower bound of the 95% confidence interval (ci) of the negative predictive value (npv) of fdg pet/ct to detect residual malignant lymph node involvement at 12 weeks after completing chemoradiation will exceed 85%.

patients with locally advanced, n2 and n3 head and neck squamous cell carcinoma (hnscc) will be recruited. all subjects receiving induction chemotherapy will undergo a baseline integrated \[18f\]fluoro-2-deoxy-d-glucose (fdg) positron emission tomography/computed tomography (pet/ct) scan before the start of concurrent chemoradiation. this baseline assessment is optional in patients not receiving neo-adjuvant treatment. all patients will undergo a dedicated fdg pet/ct protocol 12 weeks after the end of chemoradiation (primary endpoint). in pet/ct negative patients, 2 monthly control visits will be performed complemented with additional imaging as required. all patients will undergo pet/ct 1 year after completing chemoradiation unless recurrent/residual disease was already proven pathologically. patients with a pet/ct suspected for residual nodal disease must have pathological proof of nodal involvement (fine needle aspiration in non-operable patients or neck dissection in the others) before salvage chemotherapy is started. in a subset of patients receiving induction chemotherapy prior to concurrent chemoradiation, an additional fdg pet/ct scan will be performed at baseline and after 1 cycle of chemotherapy to evaluate the metabolic response to the treatment (secondary endpoint).

Eligibility criteria:
inclusion criteria: * patients with locoregionally advanced hnscc (clinically and/or radiological n2 or n3 disease, any t stage) with no evidence of distant metastases, scheduled for concurrent chemoradiation and being potential candidates for a subsequent neck dissection. * induction chemotherapy is allowed if this approach is followed by concurrent chemo-radiation. exclusion criteria: * other head and neck cancer histologies * upfront inoperable patients in the neck (eg. carotid invasion) * presence of distant metastases * a history of another primary malignancy, except when disease-free for at least 5 years after radical treatment, or except for treated basaloid skin cancer or in situ carcinoma of the cervix

Keywords: locally advanced hnscc
support groups - a model for social inclusion and reduction of bullying in school

Conditions: Bullying

Summary: study title: support groups - a model for social inclusion and reduction of bullying in school study design: cluster randomized controlled trial (crct) objective: to investigate the effectiveness of a support group intervention using a solution-focused approach among school children in 5th-7th grade in southeastern norway intervention: peer support groups with a solution-focused approach study population: school children

the primary objective of this study is to investigate the effectiveness of a support group intervention using a solution-focused approach in reducing bullying, enhancing mental health, improving quality of life, and increasing general self-efficacy among school children in 5th-7th grade. investigators hypothesize that the awareness of bullying created by the intervention, and the empowerment of children as contributors to the solution, will generate positive ripple effects benefiting all children in the intervention schools. furthermore, investigators hypothesize that children with a peer support group will exhibit lower levels of bullying, improved mental health, better quality of life, and increased general self-efficacy after the intervention compared to their baseline levels. investigators expect these effects to persist even after 3 and 6 months. aligned with the cluster rct, the investigators will undertake a parallel process evaluation to assess the extent of the intervention coverage, whether the intervention was implemented according to the protocol, and identify factors that hinder or aid the implementation of a support group intervention. for the process evaluation, investigators will use the framework presented by the medical research council guidelines focusing on the implementation (what is implemented and how), the mechanisms of impact (how the delivered intervention produces change), and the context (how the context affects implementation and outcomes).

Eligibility criteria:
inclusion criteria: * primary schools with more than 200 students * public health nurse employed in a 50% position or more exclusion criteria: * primary schools with less than 200 students

Keywords: supportgroups schoolchildren solution-focused-approach
peg3350 vs senna after urogyn surgery

Conditions: Obstructive Defecation Syndrome; Postoperative Constipation

Summary: the goal of this study is to evaluate whether polyethylene glycol 3350 (peg3350) versus senna is better at relieving postoperative constipation after urogynecologic surgery. the main questions it aims to answer are: what number of patients taking peg3350 have obstructed defecation syndrome (ods), a form of constipation, vs those taking senna in the week after urogynecologic surgery? what patient-level and procedure-level characteristics are associated with postoperative ods, in patients taking peg3350 vs senna? participants will: take their randomized medication daily for seven days after surgery fill out an ods questionnaire before and one week after surgery complete a daily bowel diary for 7 days after surgery

the purpose of this study is to evaluate whether polyethylene glycol 3350 (peg3350) versus senna is superior in the setting of postoperative constipation after urogynecologic surgery. this is a randomized controlled trial with the aim of comparing peg3350 vs senna as postoperative recommended treatment for obstructive defecation constipation. our hypothesis is that senna decreases the proportion of women with obstructive defecation constipation compared to use of peg3350 after urogynecologic surgery. women 18 years of age and older undergoing surgery for pelvic organ prolapse, stress urinary incontinence or both by the department of urogynecology at st. joseph's health hospital, will be randomized to one of two study arms: senna or peg3350. arm 1: polyethylene glycol 3350, 17g, daily, oral. arm 2: senna (sennosides) 8.6mg, 2 tablets daily, oral (up to 4 tablets twice a day). interventions would be administered after surgery on postoperative day #0 and continue for 7 days total.

Eligibility criteria:
inclusion criteria: * inclusion criteria includes women scheduled for urogynecologic surgery for pelvic organ prolapse and/or stress urinary incontinence and at least 18 years old. exclusion criteria: * exclusion criteria include undergoing concomitant bowel surgery (colonic resection, anal sphincter repair, rectovaginal fistula repair, rectopexy) or placement of a sacral neuromodulation device alone.

Keywords: obstructive defecation syndrome (ods) postoperative constipation
relationship between potential predictors and mortality in covid-19 patients ın turkey

Conditions: Covid19

Summary: in this study, the investigators planned to examine the laboratory characteristics of patients hospitalized with the diagnosis of covid-19 and to investigate their relationship with mortality.

sars-cov-2 infection is effective in many countries and has caused pandemics. it is observed that it affects patients in a wide spectrum in terms of their clinical features worldwide. it is known that age, gender, and comorbidity play an important role in the course of the disease. although mortality rates vary from country to country, there is no clear information due to the fact that the pandemic has not yet ended. in this study, the investigators planned to examine the laboratory characteristics of patients hospitalized with the diagnosis of covid-19 and to investigate their relationship with mortality in istanbul city which is the most affected by the pandemic in turkey

Eligibility criteria:
inclusion criteria: * all patients who are 18 years of age and older, positive for sars-cov-2 pcr test and / or covid-19 disease findings on ct will be included in the study. exclusion criteria: * patients with negative sars-cov-2 pcr test, pneumonia on ct but not given covid-19 treatment by not considering covid-19 by their doctor will not be included.

Keywords: covid19 ldh ferritin mortality d-dimer
hat for the treatment of sepsis associated with nasti

Conditions: Necrotizing Soft Tissue Infection; Sepsis

Summary: evaluate the impact of hat therapy versus placebo in the treatment of patients with an acute nsti and sepsis.

primary outcome: 1. hospital survival secondary outcomes: 1. duration of vasopressor therapy 2. requirement for renal replacement therapy in patients with acute kidney injury (aki) 3. icu length of stay (los) 4. change in serum procalcitonin (pct) over first 72 hours 5. change in sofa score over first 72 hours (measured as sofa score daily for four days, with day one being admission, then 3 days after, totaling 4 days of treatment with hat) 6. procalcitonin clearance (formula = initial pct - 72 hour pct divided by initial pct x 100) 7. number of wound related surgeries 8. wound status at time of hospital discharge: 1. open 2. closed

Eligibility criteria:
inclusion criteria: 1. necrotizing soft tissue infection by clinical diagnosis and requiring surgical treatment. 2. sepsis by clinical diagnosis and/or by sepsis-3 criteria15, with source attributed to the wound. 3. anticipated or confirmed intensive care unit exclusion criteria: (adapted from sevransky et. al's victas protocol) 1. age \< 18 years of age 2. weight \< 40 kg 3. prior enrollment in this study or current enrollment in another study of any kind 4. surgical findings, pathology/histology findings, or other findings determined to be inconsistent with an infectious acute nsti such that the clinical diagnosis is no longer that of a nsti 5. sepsis deemed unlikely 6. limitations of care during enrollment \[defined as refusal of cardiovascular and respiratory support modes described in inclusion criteria, including "do not intubate" (dni) status and comfort care\] 7. known allergy or known contraindication to vitamin c, thiamine, or corticosteroids \[including previous history or active diagnosis of primary hyperoxaluria and/or oxalate nephropathy, or known/suspected ethylene glycol ingestion, or known glucose-6-phosphate dehydrogenase (g6pd) deficiency\] 8. use of vitamin c at a dose of \>1g/day (iv or oral) within the 24 hours preceding first episode of qualifying organ dysfunction during a given emergency department or intensive care unit admission 9. chronic disease/illness that, in the opinion of the site investigator, have an expected lifespan of \< 30 days unrelated to current sepsis diagnosis (e.g., stage iv malignancy, neurodegenerative disease, etc.) 10. kidney stone(s) of any kind 11. history of oxalate kidney stone(s) 12. pregnancy or known active breastfeeding 13. prisoner or incarceration 14. inability or unwillingness of subject or legal surrogate/representative to give written informed consent
evaluation of safety and tolerability of ocular lubricants

Conditions: Dry Eye

Summary: the purpose of this study is to evaluate the safety profile of test formulations for an artificial tear product versus a comparator product.

subjects will be randomized to one of five different treatment sequences. subjects will attend 6 scheduled visits with an expected individual duration of participation of 11 to 42 days. this study will be conducted in australia.

Eligibility criteria:
key inclusion criteria: * able to understand and sign an informed consent form. * willing and able to attend all study visits as required by the protocol. * other protocol-defined inclusion criteria may apply. exclusion criteria: * any known active ocular disease. * any systemic condition that, in the opinion of the investigator, may affect a study outcome variable. * any ocular injury to either eye in the past 12 weeks prior to screening. * other protocol-defined exclusion criteria may apply.
radium-223 dichloride long-term follow-up program

Conditions: Neoplasm Metastasis / Bone and Bones

Summary: patients will be followed up in this study after prior treatment with bay88-8223 / radium-223 dichloride / xofigo.

this long-term follow up study will enroll subjects who will be transferred from selected interventional, company sponsored trials with radium-223 dichloride (feeder trials). the primary objectives are to define the long term safety profile of radium-223 dichloride (for up to 7 years after the last dose of radium-223 dichloride); to assess the incidence of leukemia, myelodysplastic syndrome, aplastic anemia, and primary bone cancer or any other new primary malignancy; to assess the incidence of bone fractures and bone associated events (e.g., osteoporosis); and, in subjects who receive cytotoxic chemotherapy, to assess the incidence of febrile neutropenia and hemorrhage during their chemotherapy treatment and for up to 6 months thereafter at a frequency based on local clinical practice.

Eligibility criteria:
inclusion criteria: * subject was previously enrolled in a selected company sponsored feeder trial, and has received at least 1 dose of radium 223 dichloride or placebo in the feeder trial exclusion criteria: * not applicable to this follow up study
centera-2: safety and performance study of the edwards centera-eu self-expanding transcatheter heart valve

Conditions: Aortic Valve Disease

Summary: the purpose of this study is to assess the safety and device success of the edwards centera transcatheter heart valve (thv) system in symptomatic adult patients with severe aortic stenosis.

this is a non-randomized, prospective, multi-center safety and device success study. up to two hundred (200) patients are planned to be implanted at up to 35 participating investigational centers in europe, australia and new zealand. patient participation will last for a minimum of 5 years. patients will be assessed at the following intervals: baseline, discharge, 30 days, 6 months, 1 year and annually thereafter through 5 years.

Eligibility criteria:
inclusion criteria: 1. heart team (including cardiac surgeon) agrees on eligibility including as-sessment that tavi is appropriate. 2. high surgical risk: 8 ≤ sts score ≤ 15 or 15 ≤ logistic euroscore i ≤ 40. 3. nyha ≥ ii. 4. study patient is an adult of legal consent age. 5. study patient has provided written informed consent to comply with all of the study procedures and follow-up visits. exclusion criteria: 1. acute myocardial infarction ≤ 30 days before the intended treatment. 2. untreated clinically significant coronary artery disease requiring revascularization. 3. aortic valve is a congenital unicuspid or congenital bicuspid valve. 4. mixed aortic valve disease (with predominant aortic regurgitation).

Keywords: transcatheter aortic valve replacement aortic stenosis
rna extraction and amplification from biopsy specimens in subjects with metastatic renal cell carcinoma (ags-nts-017)

Conditions: Metastatic Renal Cell Carcinoma; Genitourinary Cancer (Bladder, Prostate or Testicular)

Summary: the primary objective is to evaluate methods for ags-003 production from surgical (stage i) and metastatic biopsy (stage ii) renal cell carcinoma (rcc) and a small subset of other gu cancers (expansion cohort) specimens using core needle biopsy in subjects with rcc or other gu cancers. specifically, this study will evaluate the feasibility of rna amplification from total tumor rna isolated from tissues obtained by core needle tumor biopsy.


Eligibility criteria:
inclusion criteria: a subject with metastatic rcc, who in the opinion of the treating physician, is a potential candidate for inclusion in this study if all of the following criteria apply: 1. 18 years of age or older. 2. suspected rcc, in the opinion of the investigator 3. availability of either: * nephrectomy or other surgically removed tissue (stage i); or, * metastatic rcc biopsy tissue utilizing needle or core biopsy procedures (stage ii). 4. ≥5 biopsy specimens available from brpc. * subjects who are having a surgical procedure (i.e. metastasectomy, nephrectomy) will have these core biopsies obtained from the surgical specimen, per the brpc protocol. 5. not currently being treated with systemic therapy. exclusion criteria: 1. tumor tissue is committed to other use or inadequate for rna analysis. 2. insufficient tissue is collected in the brpc. expansion cohort for genitourinary cancers: inclusion criteria: 1. 18 years of age or older 2. suspected bladder, prostate, or testicular cancer, in the opinion of the investigator. 3. availability of surgically removed tissue or biopsy tissue. 4. at least 2 biopsy specimens available from brpc 5. not currently being treated with systemic therapy. exclusion criteria: 1. tumor tissue is committed to other use or inadequate for rna analysis. 2. insufficient tissue is collected in the brpc.
study of acute effects of sn-1 and sn-3 palmitic acid-rich or stearic acid-rich fats on metabolic markers

Conditions: Healthy

Summary: to determine the effect of degree of fat saturation on postprandial lipemia, haemostatic and inflammatory markers, gut hormone concentrations, satiety perceptions, and insulinemic responses in healthy adult subjects. study hypothesis: the degree of fat saturation does not affect postprandial lipemia, haemostatic and inflammatory markers, gut hormone concentrations, insulinemic or satiety responses in health adult subjects.

the experimental are comprise of 50g fat, 14g protein and 84g carbohydrate. each of the test fat \[palm mid fraction (pmf), shea butter (sb) and high oleic sunflower oil (hosf)\] will be compared which will be in a form of experimental meals (muffin). 33 volunteers receives 3 experimental meals (muffins) in a random order, 2 week apart, over a 6-week period. they will be randomized, blinded and will undergo a 3x3 arms crossover. the first 15-ml ("0" min) fasting venous blood samples is obtained. immediately thereafter, the subject consumes the test meal plus a glass of water within 15 minutes. the time sequence is started mid-way of consuming the test meal. at 30 min, 60 min, 90, 120 min (2 hr), 150 min and 180 min (3 hr), 210 min, and 240 min (4 hr), 15-ml each of blood is collected (via a vascular catheter inserted earlier in the subjects hand/arm).

Eligibility criteria:
inclusion criteria: 1. healthy adult male or female staff, aged between 25-50 years 2. bmi 18.5 - 25.0 kg/m2 3. blood pressure: systolic: \<140 mmhg, diastolic: \<90 mmhg c. normolipidemic (total cholesterol \<6.2 mm/l (\<240 mg/dl), fasting tg \<1.70 mm/l (\<150 mg/dl) d. fasting glucose 4.0- 7.0 mm/l exclusion criteria: 1. smokers 2. on cholesterol or blood glucose medication 3. substance abuse (eg. alcohol, cigarette smoking) 4. for women, pregnant or lactating 5. going overseas during period of study 6. blood clotting problem 7. public transportation to work

Keywords: palm mid fraction shea butter sn-1, sn-3 fatty acids cholesterol postprandial lipemia, inflammatory markers satiety gut hormone insulin
nucala® special drug use investigation (egpa, long-term)

Conditions: Churg-Strauss Syndrome

Summary: this study is a drug use investigation program of nucala. the objective of this study is to collect and assess information on the safety and effectiveness of the long-term use of nucala sc injection in daily clinical practice in subjects with eosinophilic granulomatosis with polyangiitis (egpa). all subjects who administered nucala for the treatment of egpa after its approval of indication will be included in the study. in addition, after the approval, subjects who had already received nucala for egpa prior to the conclusion of the contract will also be included. approximately 300 subjects will be included in the study. the observation period per subject is up to 96 weeks (2 years) from the start of nucala administration for egpa at a maximum. if a subject has withdrawn from/terminated administration of nucala, it will be until the withdrawal/termination. additionally, to consider the safety and effectiveness of nucala administration in subjects who had withdrawn from/terminated due to symptom improvement, 48 weeks (1 year) follow-up investigation should be conducted as much as possible. the total study duration will be approximately 3 years (2 years observation period and 1 year follow-up) from the approval of egpa indication to the lifting of approval condition. nucala is a registered trademark of the glaxosmithkline \[gsk\] group of companies.


Eligibility criteria:
inclusion criteria: * all subjects who administered nucala for the treatment of egpa after its approval of indication will be included in the study. in addition, after the approval, subjects who had already received nucala for egpa prior to the conclusion of the contract will also be included. * subjects who had been registered to nct03028480 for bronchial asthma, but had a change in treatment purpose from bronchial asthma to egpa during the observation period exclusion criteria: * not applicable.

Keywords: nucala drug use investigation egpa long-term
prospective, non-interventional, post-authorization safety study that includes all patients diagnosed as unresectable differentiated thyroid carcinoma and treated with sorafenib

Conditions: Thyroid Carcinoma

Summary: this is a non-interventional, multi center post-authorization safety study that includes all patients diagnosed as unresectable differentiated thyroid carcinoma (dtc) and treated with sorafenib within a certain period. the investigator should have made the choice of treatment (nexavar) according with the japanese package insert prior to enrolling the patient in this study. the enrollment period is of 9 months. the observation period for each patient starts when the therapy with nexavar is initiated. patients will be followed for 9 months or until it is no longer possible (e.g. lost to follow-up); this will be considered the standard observation period. those patients, to whom a total of 24 month follow up is possible, information on effectiveness including treatment duration and survival status of the patient and of keratoacanthoma and/or squamous cell cancer development will be collected.


Eligibility criteria:
inclusion criteria: * patients who start nexavar treatment for radioactive iodine-refractory unresectable differentiated thyroid carcinoma (dtc) exclusion criteria: * patients who have already received nexavar treatment

Keywords: sorafenib differentiated thyroid carcinoma, japan post marketing surveillance drug use investigation