Kornimate/medical-research-clean huggingface dataset:
nordic cystectomy study i - neutrophil-lymphocyte ratio (nlr)

Conditions: Bladder Cancer; Invasive Bladder Cancer

Summary: around 7200 cases of muscle invasive bladder cancer are diagnosed annually in the nordic countries combined. muscle invasive bladder cancer is an aggressive disease and it is linked with high mortality rates. the golden standard of treatment is radical cystectomy (rc) (the surgical removal of the bladder) and radical removal of lymph nodes in the pelvis. in addition to surgical treatment, and especially in cases where the tumour invades tissues surrounding the bladder or lymph nodes, chemotherapy is recommended. chemotherapy can be administered before or after surgery, in a neoadjuvant (nac) or adjuvant setting (ac). although most patients recover well from surgery, there are significant risks regarding radical cystectomy. the greatest challenges in planning the treatment are making individual risk assessments and prognosis for the treated patients. neoadjuvant chemotherapy is also insufficiently used and it is hard to predict how the tumour responds to chemotherapy. the purpose of this study is to collect prospective clinical data on radical cystectomy -patients in co-operation with other nordic countries: sweden, denmark, iceland and norway. the collected data is used to validate existing prediction tools and discover novel tools for prediction of morbidity related to rc and prediction of oncological outcome after rc. the study is divided into three sub-studies. the second sub-study is on the preoperative neutrophil-lymphocyte ratio (nlr). some studies suggest that nlr might be a predictor of oncological outcome of bc after rc. in addition, nlr has been suggested to correlate with nac response and outcome after nac and rc. the used cut-off value for nlr has varied between 2.26-3.0. patients will be allocated into two groups: low nlr ratio (nlr\<3), and high nlr ratio (nlr≥3). the lab test will be retrieved before rc at the time of routine clinical laboratory testing for all patients and also before the initiation of nac for patients planned to have chemotherapy. the primary end-point is bladder-cancer specific survival and, and secondary endpoints include progression-free, and overall survival.


Eligibility criteria:
inclusion criteria: 1. histologically confirmed urinary bc planned to be treated with rc with or without neoadjuvant chemotherapy. 2. histologically confirmed urinary bc planned to be treated with palliative cystectomy 2) signed informed consent 3) patient age \>18 years exclusion criteria: 1. rc for other reasons than bc 2. other forms of surgical treatment of bc than rc (e.g. bladder resection). 3. patient unwillingness to participate in the study for any reason (i.e. lack of signed consent).
sex hormones, postoperative pain and opioid use

Conditions: Postoperative Pain; Opioid Use

Summary: aim 1- to identify relationships between sex hormone levels and postoperative pain and opioid use. aim 2: to determine whether the effects of testosterone on postoperative pain and opioid use are mediated by immune factors

after signing the consent and assent forms, participants and their parents/guardians will complete several surveys, including demographic, behavioral, pain, substance use and analgesic risk assessment measures, and developmental surveys. in addition, a blood sample (for hormonal and immune analyses) will be collected on the day of the surgery and/or postoperative. surgery-related parameters including postoperative pain, and opioid type and doses during the hospital time will be collected. in addition, before or after the surgery, patients and their parents/guardians will be interviewed. the interview will include questions about the surgery and about potential future study assessing the efficacy of sex hormone treatment on opioid use. longitudinal measures. at routine follow-up with the surgeons or after 1 week, 1 month, 3 months, and 6 months, study staff will contact patients to inquire about persistent pain (location, severity), and persistent opioid use. based on previous studies, we estimate that ∼30% will have persistent postoperative pain, and ∼5% will have persistent opioid use.after signing the consent and assent forms, participants and their parents/guardians will complete several surveys, including demographic, behavioral, pain, substance use and analgesic risk assessment measures, and developmental surveys. in addition, a blood sample (for hormonal and immune analyses) will be collected on the day of the surgery and/or postoperative. surgery-related parameters including postoperative pain, and opioid type and doses during the hospital time will be collected. in addition, before or after the surgery, patients and their parents/guardians will be interviewed. the interview will include questions about the surgery and about potential future study assessing the efficacy of sex hormone treatment on opioid use. longitudinal measures. at routine follow-up with the surgeons or after 1 week, 1 month, 3 months, and 6 months, study staff will contact patients to inquire about persistent pain (location, severity), and persistent opioid use. based on previous studies, we estimate that ∼30% will have persistent postoperative pain, and ∼5% will have persistent opioid use.

Eligibility criteria:
inclusion criteria: pediatric female patients between the ages 11-16 undergoing an orthopedic (trauma and non-trauma) surgical procedure involving a long bone or joint, or the spine, english speaking exclusion criteria: pregnancy; diagnosis of chronic pain, psychiatric, developmental or neurological disorders, disorders that are associated with pubertal maturation (e.g., precocious puberty).
anterior temporal epilepsy neuropsychological assessment of faces

Conditions: Anterior Temporal Epilepsy; Anterior Temporal Lobectomy; Face Perception

Summary: the purpose is to evaluate neuropsychological effects of anterior temporal epilepsy in face perception by comparison of performances of epileptic patients and control individuals, sex-, age- and socio-educational level-matched. secondary purposes are to prospectively evaluate neuropsychological impact of anterior temporal lobectomy performed for surgical treatment of anterior temporal epilepsy on face perception (exploratory study).


Eligibility criteria:
inclusion criteria: all: * informed consent * affiliation to social security * preliminary medical examination patients with epilepsy: * symptomatic drug-resistant anterior temporal epilepsy (confirmed with video-electroencephalography and magnetic resonance imaging and if necessary intracerebral seeg exploration) * patient needing anterior temporal lobectomy and undergoing pre-surgery conventional intercritical assessment for surgery decision * nonverbal iq ≥ 70 (wais-iv) * at least 6 successful vosp tests (perception test) exclusion criteria: all: * persons under legal protection or incapable to consent * persons deprived of liberty by juridical or administrative decision patients with epilepsy: - sever visual disorders of neurological or ophthalmological origin control individuals: * psychiatric or neurological disorders * important ophthalmological disorders
effectiveness of silver nitrate solution in the treatment of anal fistula

Conditions: Anal Fistula

Summary: effectiveness of silver nitrate solution in treatment of anal fistula is is aimed to be investigated.

the anal fistula is a granulation tissue-lined tract, we thought of a way to ablate this granulation tissue using a chemical agent, which would eventually induce healing with fibrosis and closure of the tract without any surgical intervention. aiming to reduce the surgery related complications; we investigated the effectiveness of silver nitrate solution as a chemical agent in the treatment of anal fistula.

Eligibility criteria:
inclusion criteria: all patients with the diagnosis of anal fistula patients with recurrence exclusion criteria: patients who do not sign the informed consent
complaints associated with use of pre-filled pen b with type 2 diabetics on twice-daily insulin

Conditions: Type 2 Diabetes Mellitus

Summary: trial of new insulin injection pen called pre-filled pen b by type 2 diabetics in take home situations. patients must use insulin lispro injection \[rdna origin\] low mix twice daily during the trial.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * already on lilly insulin or beginning insulin therapy * 25 to 75 years old inclusive exclusion criteria: * currently using, or had used during previous month, oral diabetes medication that is not approved for use in combination with insulin in patient's country * more than 3 unexplained episodes of severe hypoglycemia within 6 months prior to trial
comparison of clinical outcomes pod l gf vs pod f gf in asian eyes

Conditions: Cataract; Lens Opacities; Presbyopia

Summary: prospective, randomised, controlled, single-surgeon, single-center clinical study to compare the clinical outcomes of two trifocal iols differing in the dominance of additional power. the investigational device pod l gf shows dominance for the intermediate addition (+1.75 d), whereas the control device pod f gf shows dominance for the near addition (+3.5 d). implantation of the iols is bilaterally.

this is a prospective, randomised, controlled, single-surgeon, single-center clinical study whereby patients undergoing routine cataract surgery will have bilateral implantation of trifocal intraocular lenses. the patients will either be implanted with the hydrophobic iol finevision pod l gf or the hydrophobic iol finevision pod f gf (both lenses: (physiol, liège, belgium). the devices under investigation (finevision pod l gf and pod f gf) are trifocal glistening-free acrylic intraocular lenses (iols) manufactured by the sponsor of this study physiol sa/nv. both consist of the same hydrophobic material. the main difference between the lenses is the dominance of additional power. the investigational device pod l gf shows dominance for the intermediate addition (+1.75 d), whereas the control device pod f gf shows dominance for the near addition (+3.5 d). the iols will be implanted as part of the routine cataract surgery on patients suffering from cataract development. subjects participating in the trial will attend a total of 10 study visits (1 preoperative, 2 operative and 7 postoperative) over a period of 6 months. subjects would have the option for unscheduled visits if required medically. primary and secondary endpoint data will be collected at the 6 months follow up visit. data analyses will be done after the last patient finished the final examination to support the study publication plan.

Eligibility criteria:
inclusion criteria: * cataractous eyes with no comorbidity * availability, willingness and sufficient cognitive awareness to comply with examination procedures * signed informed consent exclusion criteria: * age of patient \<40 years * irregular astigmatism * regular corneal astigmatism \>0.75 dioptres by an automatic keratometer or biometer or \>1.0 dioptres if the steep axis of cylinder is between 90° and 120° * difficulty for cooperation (distance from their home, general health condition) * acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc...) * any ocular comorbidity * history of ocular trauma or prior ocular surgery including refractive procedures * capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic uveitis, marfan's syndrome) * pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions) * amd suspicious eyes (determined by oct)

Keywords: intraocular lens trifocal hydrophobic
tegio consolidation therapy for npc patients with high risk of metastasis

Conditions: Nasopharyngeal Carcinoma

Summary: oral administration of tegio capsules for 12 months for npc patients with high risk of metastasis (ajcc stage t3-4n2m0 or t1-4n3m0) was tested trying to reduce distant metastasis，safety was also evaluated.

in this study, npc patients (stage t3-4n2m0 or t1-4n3m0) who finished the curative chemoradiation will be randomized to the observation group and treatment group (60 mg bid, p.o.，d1-28，q6wks; continued until disease progression, unacceptable toxicity, or over 1 year). the primary endpoint is distant failure-free survival (d-ffs), secondary end points include overall survival (os), locoregional failure-free survival (lr-ffs), progression-free survival (pfs) and toxic effects,. all efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.

Eligibility criteria:
inclusion criteria: 1. age 18-70 ys 2. performance status of eastern cooperative oncology group (ecog) grade 0 -2 3. tumor staged as 8th american joint committee on cance (ajcc) t3-4n2m0 or t1-4n3m0 with histologically confirmed 4. within 12weeks after completion of the curative radiotherapy treatment 5. disease was controlled after radiotherapy 6. with adequate hematologic (neutrophil count \> 1.5×10\^9/l, hemoglobin \> 90g/l and platelet count \> 100×10\^9/l), hepatic (alanine aminotransferase, aspartate aminotransferase ≤ 1.5×uln, bilirubin ≤ 1.5×uln, alkaline phosphatase \ 50 ml/min) 7. patients must be informed and written informed consent was finished. exclusion criteria: 1. allergic to tegio. 2. illness may interfere with oral medication, including dysphagia, chronic diarrhea, or ileus 3. prior malignancy except treated basal cell or in situ cervical cancer. 4. pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period). 5. severe comorbidities may bring unacceptable risk or affect the compliance of the trial, including but not limited to unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \> 1.5×uln), and emotional disturbance.

Keywords: adjuvant chemotherapy tegio
validation of the 1-minute sit-to-stand test in patients with copd

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: this is a study to provide an in-depth validation of the 1-minute sit-to-stand test as a measure of exercise capacity in patients with chronic obstructive pulmonary disease (copd). patients will perform the 1-minute sit-to-stand test and other validated exercise tests and questionnaires.

exercise capacity is a strong predictor for mortality, exacerbations and health-related quality of life (hrql) in patients with chronic obstructive pulmonary disease (copd). the 1-minute sit-to-stand test (1-min sts test) is a promising exercise capacity test that is simple to conduct and requires few resources. this study will provide an in-depth validation of the 1-min sts test, specifically evaluating the tests reliability, validity, responsiveness to change and minimal clinically important difference. the study will also assess the predictive properties of the 1-min sts test with regards to detecting exacerbations, as well as identify patterns of physical activity and patient-reported symptoms of exacerbations.

Eligibility criteria:
inclusion criteria: * copd diagnosis according to gold criteria; post bronchodilator fev1/fvc\<70% * male and female patients ≥40 years of age * able to do at least 5 repetitions in the 1-min sts test at baseline assessment * written informed consent by the participant exclusion criteria: * lower limb joint surgery in the preceding 3 months * too unstable medically to perform exercise tests * predominant neurological or musculoskeletal limitation to walking * cognitive reading impairment and/or difficulties managing the ediary and step-counter
sdf application in oral cancer patients to prevent dental caries

Conditions: Dental Caries

Summary: the texas a \& m college of dentistry, with partner texas oncology-baylor charles a. sammons cancer-center radiation-oncology, proposes to conduct a preliminary clinical study (nih stage 0) to pilot test a randomized clinical trial of the efficacy of professionally applied 38% silver diamine fluoride to prevent tooth decay in 60 patients who are being treated with radiation for life threatening head and neck cancer.

head and neck cancer has increased in texas over the last two decades. radiation-induced tooth decay is a devastating yet potentially preventable side effect of the cancer treatment. silver diamine fluoride, already the standard of care in children, is inexpensive, easy to apply, and safe. the objective of the research is to conduct a single site pilot rct (nih stage 0) to determine feasibility and preliminarily assess the efficacy of 38% silver diamine fluoride and 5000 ppm fluoride gel for prevention of radiation-induced dental caries over 6 months. eligible participants will be up to 60 head and neck cancer patients who are scheduled for radiotherapy. the proposed intervention will be applied within 1 m before and at 1- and 3-m post radiation. the primary outcome is dental caries surfaces at 6 months post-radiotherapy (dmfs).secondary outcomes are the gingival index, gingival bleeding index, mdasi-hn, and oral health quality of life score will be secondary outcomes.

Eligibility criteria:
inclusion criteria: * diagnosis of head and neck cancer exclusion criteria: * prognosis less than 1 year * radiation field of treatment does not involve jaws

Keywords: oral and pharyngeal cancer xerostomia silver diamine fluoride sodium fluoride gel 5000 ppm
vitalis study - observational study on the quality of life in patients under treatment for b-chronic lymphocytic leukemia (b-cll)

Conditions: Leukemia, B-Cell, Chronic

Summary: 300 patients, starting a new pharmacological treatment for b-cll, were enrolled by 36 italian centres for assessing the quality of life (qol). a descriptive analysis of qol and the correlation of the age, sex, stage of disease, time from first b-cll diagnosis, number of previous b-cll treatments, reason of starting of the new b-cll treatment: therapeutic regimen, type of centre, b-cll treatment lasting, response to b-cll treatment.

the study has previously been posted by schering ag, germany. schering ag, germany has been renamed to bayer schering pharma ag, germany. bayer schering pharma ag, germany is the sponsor of the trial.

Eligibility criteria:
inclusion criteria: * aged \>/=18 years * patients of either sex with b-cll, who are starting a new pharmacological treatment for b-chronic lymphocytic leukemia (1st, 2nd, 3rd, 4th) * foreseen duration of cll therapy \</= 6 months * b-chronic lymphocytic leukemia progressive stage a, stage b or c (according to binet system), or ii-iv (according to rai system) * who performance status \</= 2 * life expectancy \</= 6 months * signed informed consent for personal data's treatment and availability to fill in the qol questionnaire exclusion criteria: * patients with any other tumour disease * chronic lymphocytic leukemia therapy in the last 30 days before v0 * more than 3 previous cll treatments (the therapy is defined by the drug and/or the treatment period) * previous stem cells transplantation * concurrent or in the last 30 days participation to any other clinical trial * any medical or psychological conditions that might compromise the capacity to sign the consent for personal data's treatment or to fill in the qol questionnaire

Keywords: b- chronic lymphocytic leukemia
improving quality of care for the dying patient in hospice: a quasi experimental trial in liguria region

Conditions: End-of-Life

Summary: this is a before-after phase ii study, according to the medical research council framework, investigating the feasibility of introducing the liverpool care pathway for the dying patient (lcp) in 5 ligurian hospices.


Eligibility criteria:
inclusion criteria: * all patients deceased in the hospice during the evaluation period * approval of ethics committee exclusion criteria: * prior use of lcp in the hospice * deceased was a relative of a hospice member of staff

Keywords: dying patients hospice liverpool care pathways
the clinical trial of adr-001 for iga nephropathy

Conditions: Glomerulonephritis , IGA

Summary: the purpose of this study is to evaluate the safety and the tolerability of adr-001 in immunoglobulin a (iga) nephropathy patients. in addition, the investigators will evaluate the efficacy of adr-001 for iga nephropathy patients.


Eligibility criteria:
inclusion criteria: 1. iga nephropathy diagnosed by renal biopsy. 2. meet any of the following criteria. i. urinary protein at screening is 0.5 g / gcr or more and egfr is 60 ml / min / 1.73m\^2 or more even if corticosteroids are used for 6 months or more before screening. ii. urine protein of 1.0 g / gcr or more and egfr of 30 ml / min / 1.73 m\^2 or more and less than 60 ml / min / 1.73 m\^2 at screening even if corticosteroids are used for 6 months or more before screening. iii. urine protein of 0.5 g / gcr or more and less than 1.0 g / gcr at screening and egfr of 20 ml / min / 1.73m\^2 or more and 60 ml / min / 1.73m\^2 or urine protein of 1.0 g / gcr or more at screening and egfr is 20 ml / min / 1.73m\^2 or more and less than 30 ml / min / 1.73m\^2. 3. over 20 years old. 4. able to provide informed consent. however, in the first cohort, only 2) -i is applied in the selection criteria 2), and in the second cohort, 2) -i, ii, and iii are applied. exclusion criteria: 1. nephropathy other than iga nephropathy, and primary and secondary nephrotic syndrome. 2. start or increase drug therapy for iga nephropathy with corticosteroids, immunosuppressants, renin angiotensin system (ras ) inhibitors, antiplatelet drugs, anticoagulants (warfarin), and n-3 fatty acids (fish oil) within 3 months . palatal tonsillectomy within 6 months. 3. treatment with other cells. 4. participated within 3 months or participating in other clinical trials . 5. penal transplantation within 3 years or scheduled. 6. diabetics not well controlled. 7. malignant neoplasm or history of malignant neoplasm within 5 years, or judged possibility of malignant tumor. 8. suspected of active infection. 9. positive for hepatitis b (hb), hepatitis c virus (hcv),human immunodeficiency virus (hiv), human t-cell leukemia virus 1 (htlv-1) or syphilis. 10. history of severe hypersensitivity or anaphylactic reaction. 11. allergic to penicillin antibiotics, aminoglycoside antibiotics or dimethyl sulfoxide (dmso). 12. serious complications not related to iga nephropathy. 13. bleeding or may bleed, shallow days after surgery or trauma to the central nervous system, history of hypersensitivity to components of heparin preparations, history of heparin-induced thrombocytopenia previous patient. 14. during pregnancy, lactation, may be pregnant or both men and women who do not agree to give birth control under the guidance of the investigator or investigator during the study period.