Kornimate/medical-research-clean huggingface dataset:
patient reported outcomes by patients with metastatic renal cell carcinoma

Conditions: Metastatic Renal Cell Carcinoma; Kidney Cancer; Kidney Neoplasm; Urologic Cancer; Urologic Neoplasms; Advanced Renal Cell Carcinoma

Summary: the purpose of prorececa is to test whether adding weekly active patient-reported outcomes to the treatment of patients with metastatic renal cell carcinoma can improve patient-reported physical function.

prorececa is a two-armed randomized controlled trial for patients with metastatic renal cell carcinoma initiating 1st or 2nd line of standard therapy. patients will be randomized to either receiving questions from patient-reported outcomes version of the common terminology criteria for adverse events (pro-ctcae™) with a specifically developed alert-algorithm and the european organization for the research and treatment of cancer quality of life questionnaire (eortc qlq-c30) or receiving standard procedure regarding side effect registration and handling. the hypothesis is that weekly active patient-reported outcomes in the intervention group can improve physical function 30% compared to the group who receive standard care and standard handling of side effects. a total of 174 patients will be included with 87 patients in each arm. primary endpoint is physical function reported by the patient after 3 months of treatment. the patients will assess their physical function by completing the eortc qlq-c30.

Eligibility criteria:
inclusion criteria: 1. patients with metastatic renal cell carcinoma 2. age ≥ 18 years 3. starting 1st or 2nd line treatment at enrolment 4. performance status (ps) ≤ 2 5. able to read danish 6. no serious cognitive impairment 7. patient has given written informed consent exclusion criteria: 1. no smart phone 2. patient participating in other interventional studies. this is only relevant for studies that might interfere with the intervention. cases of doubt will be settled by the protocol committee. 3. persons deprived of liberty or under guardianship or curators 4. dementia, mental alteration or psychiatric disease that can compromise informed consent from the patient and / or adherence to the protocol and the monitoring of the trial 5. earlier participation in prorececa (e.g. when changing from 1st to 2nd line of treatment)

Keywords: patient-reported outcomes electronic reporting of symptoms physical function
enduring happiness and continued self-enhancement (enhance) for covid-19

Conditions: Well-Being

Summary: this study is a randomized controlled trial of an online, evidenced-based intervention (the enhance program) that was modified to address the health and well-being challenges of covid-19. eligible participants will be randomized into the enhance or wait-list control group over a 12-week period. enhance participants will be introduced, and asked to practice, 10 evidenced-based principles and skills of happiness and well-being. participants will complete an online survey about their health and well-being at baseline, midway (or 6 weeks), post-assessment (or at the end of the 12-week study), and 3-months following the end of the study.

the study is designed as a 12-week, two-armed, randomized controlled trail to assess the efficacy of a covid-19-modified version of the enduring happiness and continued self-enhancement (enhance) program. the enhance program represents a 12-week multi-construct, evidenced-based intervention for improving overall happiness and subjective well-being. the enhance program was modified specifically to address the known health and well-being challenges of the covid-19 pandemic. eligible participants will be randomized into either the enhance program or wait-list control (wlc) group. enhance participants will be introduced to 10 evidenced-based principles that have been shown to improve health and well-being outcomes. participants will be further guided to systematically practice these principles in their daily lives using a small-changes approach. wlc participants will be asked to continue life a usual, and provided some additional health and well-being resources that can be accessed online to support current, ongoing distress, if needed. participants will be asked to complete an online survey about their emotional, social, and physical well-being at baseline (or at the start of the study), midway (or 6-weeks into the study), and at post-assessment (or at the end of the study period). at the end of the study period, all control participants will also be offered the full enhance program. investigators expect that participants receiving the enhance program will show improvements across all negative (e.g., depression, anxiety) and positive (e.g., life satisfaction, quality of life) variables from baseline to post-study. investigators further expect there to be immediate positive health and economic outcomes linked to active participation in the enhance program (versus the wlc group). investigators believe the impacts of this research will include (a) mitigating the risk of a severe onset of mental health problems related to anxiety, depression, post-traumatic stress, and suicide, (b) increasing positive mental health and well-being, and (c) increasing physical health in participants across time.

Eligibility criteria:
inclusion criteria: * individuals who are fluent in english and are 19 years or older. exclusion criteria: * n/a

Keywords: health and well-being positive psychology intervention online bibliotherapy
initiating acp in general practice. a phase ii study

Conditions: Life-threatening Illness; Palliative

Summary: end-of-life care often fails in providing optimal patient-centred care and quality of life. patients frequently suffer from inadequate control of pain, from a lack of communication about their illness and options for treatment, and from poor psychosocial and spiritual support. advance care planning (acp) can tackle these problems by providing patients with an opportunity to formulate their wishes and plan their future care, should they become incapable of participating in medical treatment decisions. previous studies show that acp improves concordance between patient's preferences and end-of-life care received and quality of care at the end-of-life. however, acp is yet to be embedded in routine clinical practice and public consciousness. general practitioners (gps) are in an ideal position to discuss acp with their patients. by introducing acp during a routine office visit, gps can facilitate a structured discussion of the patient's wishes for end-of-life care. however, no acp models have been systematically developed and tested in general practice. we developed a complex intervention to improve the initiation of acp in general practice following the steps of an international guidance for development and evaluation of complex interventions. before performing a full-scale intervention trial to study the effectiveness of this intervention on quality of care and quality of life, this model needs to be validated and tested in a pilot trial.

aim 1) to conduct the phase ii trial with gps who will facilitate a structured acp session with patients with a serious or life-threatening illness versus usual care and 2) to evaluate and validate the acp intervention in terms of feasibility, acceptance to gps and patients with a serious or life-threatening illness, and preliminary proof of effectiveness method the implementation and preliminary evaluation of this intervention will be done by following the steps of the medical research council (mrc) framework on complex intervention designs. this framework proposes a stepwise approach going from phase 0 to phase iv. phase 0-i were previously conducted by the research team and comprised the development of the intervention. this project proposal comprises phase ii (exploratory trial) in which the feasibility and acceptability of the intervention will be evaluated.

Eligibility criteria:
inclusion criteria: * patients with a serious or life-threatening illness * older than 18 years * dutch speaking * eligible according to the surprise question * able to give informed consent * able to complete questionnaires and participate in qualitative interview exclusion criteria: * younger than 18 years * incompetent to participate due to mental incapacity * unable to give informed consent * unable to complete questionnaires or participate in qualitative interviews

Keywords: advance care planning general practice family practice palliative care end-of-life care
nonoperative treatment of acute achilles tendor rupture

Conditions: Achilles Tendon Rupture

Summary: a prospective, non-randomised, observational study to investigate the clinical and biomechanical outcomes and prevalence of reruptures after operative or nonoperative treatment of acute achilles tendon rupture.


Eligibility criteria:
inclusion criteria: * acute achilles tendon rupture with clear onset of symptoms * closed rupture * resides in the catchment area of our hospital district exclusion criteria: * avulsion fractures in the calcaneus * unwillingness to participate * inability to communicate using finnish language

Keywords: achilles tendon rupture nonoperative treatment functional rehabilitation operative treatment biomechanical measurements
pharmacokinetic assessment of ceftazidime in intermittent hemodialysis patients

Conditions: Renal Failure

Summary: ceftazidime is a broad spectrum cephalosporin with high activity against a variety of gram-negative pathogens, including pseudomonas aeruginosa. an open-label study of intravenous ceftazidime pharmacokinetics will be performed in patients undergoing intermittent hemodialysis at northwestern memorial hospital to determine the clearance of ceftazidime in high flux hemodialysis.


Eligibility criteria:
inclusion criteria: * eligible patients are male or female adults ≥18 years of age with an expected hospital stay of at least 48 hours, who have end-stage renal disease and been receiving intermittent hemodialysis for at least 90 days. * eligible patients will additionally have either central or peripheral intravenous access, and will already be prescribed ceftazidime per their primary providers. * written informed consent in a form approved by northwestern memorial hospital, northwestern university institutional review board, and midwestern university institutional review board will be completed by the patient prior to enrollment. exclusion criteria: * patients that only receive one dose of ceftazidime in total * patients with potentially altered pharmacokinetic parameters (pregnant patients, burn patients, and those that are morbidly obese (bmi ≥ 40 kg/m2). * not meeting inclusion criteria
the safety & efficacy of intravitreal aflibercept injection in patients with persistent central serous chorioretinopathy

Conditions: Central Serous Chorioretinopathy

Summary: a preliminary study to determine the safety and efficacy of intravitreal aflibercept injection in patients with persistent central serous chorioretinopathy.

intravitreal aflibercept injection for persistent central serous chorioretinopathy: a prospective pilot study

Eligibility criteria:
inclusion criteria: * pre-treatment acuity of 20/40- 20/320 * macular fluid on optical coherence tomography for greater than 3 months * leakage on fluorescein angiography * willing and able to comply with clinic visits and study-related procedures * provide signed informed consent exclusion criteria: * treatment for cscr in the study eye (anti-vegf, pdt, or laser) within three months prior to study enrollment * presence of choroidal neovascularization on enrollment imaging * prior vitrectomy in the study eye * presence of any substantial ocular disease (other than cscr) that may compromise vision in the study eye and /or confound interpretation of the data; e.g. substantial cataracts, advanced glaucoma, optic neuritis, optic neuropathy or atrophy, marked macular atrophy, ocular vascular occlusion, history of retinal detachment, uveitis, viral or other forms of chorioretinitis, etc. * history of rhegmatogenous retinal detachment or macular hole (stage 3 or 4) in the study eye * uncontrolled glaucoma in the study eye (defined as iop ≥ 25 mmhg despite treatment with anti-glaucoma medication) * active ocular infection or inflammation in the study eye * active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye * prior treatment with systemic anti-vegf agents * cerebrovascular accident or myocardial infarction within the preceding 6 months. * history of allergy to fluorescein, povidone iodine (betadine) or aflibercept * participation in a study of an investigational drug or device within 30 days prior to potential enrollment into the study * pregnant or breast-feeding women sexually active men\* or women of childbearing potential\*\* who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device \[iud\]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly) * contraception is not required for men with documented vasectomy. * postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential. pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.

Keywords: persistent central serous chorioretinopathy regeneron csr cscr
impact of persistent microvascular obstruction by cardiac magnetic resonance on prognosis for st-segment elevation myocardial infarction

Conditions: ST Elevation (STEMI) Myocardial Infarction

Summary: the aims of the study were to evaluate the predictive value of persistent microvascular obstruction (mvo) by cardiac magnetic resonance for main adverse cardiac events in st-segment elevation myocardial infarction patients. mvo in the acute phase of myocardial infarction has been considered to be strong predictor of a poor prognosis. we plan to explore the relationship between persistent mvo and the long-term prognosis of patients with stemi. we made hypothesis that patients with persistent mvo have a poor prognosis.


Eligibility criteria:
inclusion criteria: * st-segment elevation myocardial infarction undewent primary percutaneous coronary intervention exclusion criteria: * contraindications for cardiac magnetic resonance * severe heart failure * previous myocardial infarction.

Keywords: microvascular occlusion; st-segment elevation myocardial infarction prognosis
effects of creatine and glucoseamine/ chondritin sulfate co-supplementation in addition to exercise and physical therapy in patients with knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: osteoarthritis is the 11th highest contributor to disability world wide. in terms of conservative management of patients with knee osteoarthritis, resistance exercise has been shown to be an effective intervention for reducing pain and cartilage degeneration and improving muscle strength, joint biomechanics and physical functioning. but, research shows that co supplementation can further augment the effects of resistance exercise. however, it is imperative to point out that the existing evidence is majorly focused on the individual effects of resistance exercise training and non-pharmacological supplementation, and is still deficient in the effects of co-supplementation in addition to resistance exercise training in patients with knee osteoarthritis.


Eligibility criteria:
inclusion criteria: * age 40-70 years * knee oa with history not less than three months. * radiological evidences of grade iii or less on kellgren classification. * knee pain on vnrs no more than 8/10 exclusion criteria: * neuromuscular conditions that may lead to fatigue such as multiple sclerosis * signs of serious pathology (e.g., malignancy, inflammatory disorder, infection). * history of trauma or fractures in lower extremity. * signs of lumbar radiculopathy or myelopathy. * history of knee surgery or replacement. * patients on intra-articular steroid therapy within two months before the commencement of the study. * impaired skin sensation. * impaired renal function
gastric cancer screening and alarm symptoms in early gastric cancer

Conditions: Early Gastric Cancer

Summary: most of the early gastric cancer are asymptomatic. symptoms of advanced gastric cancer are weight loss, abdominal pain, nausea, vomiting, anorexia dysphagia, gastrointestinal bleeding. gastric cancer found according to warning symptoms such as gastrointestinal bleeding, weight loss usually can not be cured. therefore, early gastric cancer can not be detected and impossible to treatment if endoscopy is performed according to the warning signs. national gastric cancer screening is conducted in men and women of more than 40 years old. the purpose of screening for gastric cancer is discovering a case of possible cure, so increasing the survival rate. the purpose of this study is review of the feasibility of screening for gastric cancer.


Eligibility criteria:
inclusion criteria: * gastric cancer patients in st.mary's hospital exclusion criteria: * gastric lymphoma, gastric gist patients in st.mary's hospital
effect of burosumab on the inflammatory profile of patients with x-linked hypophosphatemic rickets flam-xlh

Conditions: X-Linked Hypophosphatemic Rickets

Summary: x-linked hypophosphataemia (xlh) is a rare genetic disorder associated with increased circulating levels of the hormone fgf23, most commonly through mutation of the phex gene. xlh is associated with a wide range of clinical manifestations in children and adults, all of which can impact on their health-related quality of life. conventional treatment (or standard of care, soc) consists of phosphate supplementation and active vitamin d analogues. the management of patients with xlh has been modified in france since 2018 with the authorisation of the anti-fgf23 antibody, burosumab, in paediatrics (and in 2020 in adults). a propensity for overweight/obesity has recently been demonstrated in these patients. could extra-skeletal effects of fgf23, in particular on the inflammatory profile of patients, be responsible for these manifestations? obesity has been associated with inflammation in other populations. in terms of inflammation, there is a close link between fgf23 and inflammation: inflammatory cytokines increase the production of fgf23, which in turn increases inflammation by stimulating the production of inflammatory cytokines. osteoclastogenesis and inflammation are linked and inflammation has been shown to increase bone resorption. in a recent study, the investigators showed that osteoclastogenesis was significantly impaired in cells obtained from xlh patients compared with control patients, and that osteoclasts obtained from xlh children showed higher gene expression of inflammatory markers than controls. interestingly, no difference was observed in circulating monocytic cells between the two patient subgroups, conservative treatment and burosumab, whereas the inflammatory profile at the end of osteoclastic differentiation was reduced in cells derived from patients receiving burosumab. the aim of this study is therefore to investigate the inflammatory profile of circulating monocytic cells on the day of burosumab injection (d0) and seven days later (peak effect of anti-fgf23).


Eligibility criteria:
inclusion criteria: * children and adults with genetically confirmed xlh followed at the lyon reference centre for rare calcium, phosphorus and magnesium diseases * patients treated with burosumab * patients \>12 kg. * patients and parent/guardian who have been informed of the study and who do not object to participate exclusion criteria: * patients undergoing treatment with oral corticosteroids, or who have received more than 3 months of corticosteroid therapy in the past. * patients who have received or are currently receiving immunosuppressive therapy. * patients suffering from an inflammatory disease * pregnant or breast-feeding women * persons deprived of their liberty by judicial or administrative decision * persons not affiliated to a social security scheme or beneficiaries of a similar scheme

Keywords: xlh burosumab inflammation
evaluation of diffusion mri as a tool in planning deep brain stimulation (dbs)

Conditions: Movement Disorders

Summary: the purpose of this study is to explore the relationship between deep brain stimulation implantation site and dti (diffusion tensor imaging) derived measures for the region and later compare this to the clinical treatment outcomes.


Eligibility criteria:
inclusion criteria: * deep brian stimulation surgery exclusion criteria: * dbs treatment stopped before 12 month followup
the (cost-) effectiveness of paediatric laparoscopic hernia repair compared to open hernia repair

Conditions: Inguinal Hernia

Summary: this study assess the (cost-)effectiveness of open versus laparoscopic percutaneous inguinal ring suturing (pirs) technique for unilateral inguinal hernia repair in children aged 0-16 years.

research question inguinal hernia repair is one of the most common operations in children. after open unilateral inguinal hernia repair, 6-8% of patients develops an inguinal hernia on the contralateral side. laparoscopic inguinal hernia offers the opportunity to inspect the contralateral groin and repair an asymptomatic contralateral hernia, if present. main question: what is the most (cost-)effective treatment strategy for unilateral inguinal hernia repair in children aged 0-16 years: the open or laparoscopic percutaneous inguinal ring suturing (pirs) technique? hypothesis the optimal treatment for children with an inguinal hernia is laparoscopic hernia repair, since the surgeon can inspect and possibly, repair, the contralateral groin. laparoscopic inguinal hernia repair results in less operations and exposure to anaesthesia, less hospital admissions, lower costs and a better quality of life compared to open inguinal hernia repair. study design multicentre randomized controlled trial. study population children aged 0 - 16 years with a unilateral inguinal hernia. intervention inguinal hernia repair with the laparoscopic pirs technique. usual care/comparison inguinal hernia repair with the open technique. outcome measures primary: number of operations related to inguinal hernia repair and cost-effectiveness (social and healthcare related costs). secondary: complications, total duration of surgery (including anaesthesia and total duration of operating room time), post-operative pain, length of hospital stay, time to normal daily activities, cosmetic appearance, health-related quality of life. all outcome measures will be assessed within two years after the primary inguinal hernia correction. sample size/data analysis 464 patients (power of 0.80, alpha 0.05). cost-effectiveness analysis/budget impact analysis the economic evaluation will be assessed from a societal and health care perspective. cost-effectiveness will be assessed in terms of qalys and the primary and secondary outcomes. a budget impact analysis will be conducted using the "budget impact analyse - leidraad en rekentool" of zonmw. missing data will be imputed.

Eligibility criteria:
inclusion criteria: 1. infants aged 0 months to 16 years of age with a primary unilateral inguinal hernia undergoing hernia repair exclusion criteria: 1. incarcerated inguinal hernia, which have to be operated immediately, 2. recurrent hernia 3. ventricular-peritoneal drain 4. non-descended testis 5. parents who are not able to understand the nature or consequences of the study.

Keywords: pediatric pirs open inguinal hernia repair