Kornimate/medical-research-clean huggingface dataset:
radical colorectal resection and hyperthermic intraperitoneal chemotherapy (hipec) in locally advanced colorectal cancer

Conditions: Malignant Neoplasm of Colorectum

Summary: the efficacy of hipec in prevention of local recurrence, distant metastasis or peritoneal metastasis in locally advanced colorectal cancer is not definite. the hypothesis of the trial is that radical colorectal resection plus hipec is superior to only radical colorectal resection in terms of overall survival.

to determine the efficacy of hipec in the treatment of locally advanced colorectal cancer, patients are randomized into hipec group and control group. in hipec group, the patients undergo radical colorectal resection with lymphadenectomy and hipec with paclitaxel and 5-fu. patients in the control group just undergo radical colorectal resection with lymphadenectomy. patients in both groups receive 8 cycles of postoperative chemotherapy (xelox) and are followed up for 5 years or until death. the trial is designed as a prospective, randomized, open, multicenter and parallel group study.

Eligibility criteria:
inclusion criteria: * histological proved diagnosis of locally advanced colorectal cancer. * no evidence of distant metastases or peritoneal metastases. * preoperative examination (ct/mri) demonstrated resectable colorectal cancer with t3-t4 stage. * eligible for radical colorectal resection with lymphadenectomy. * have not received cytotoxic chemotherapy or radiotherapy. * written informed consent is obtained prior to commencement of trial treatment. exclusion criteria: * existence of distant metastasis or peritoneal metastasis during surgery (m1). * any previous chemotherapy or radiotherapy * active systemic infections * inadequate cardiac function, renal function, liver function or bone marrow function at the beginning of the trial. * female patients who are pregnant or breast feeding
multimodal monitoring of radiotherapy response in squamous cell cancer

Conditions: Squamous Carcinoma; Head and Neck Cancer; Anal Cancer; Lung Cancer; Esophageal Cancer; Cervix Cancer

Summary: the study's aim is to define imaging and molecular bio-markers for prediction of radiotherapy response of squamous cell carcinomas, in an early treatment phase.

patients with squamous cell carcinoma of the head \& neck, anal canal, cervix, esophagus or lung will be assessed before start of radiotherapy and 1-2 weeks after start. multi-parametric mri and 18f-2-fluoro-2-deoxy-d-glucose fluorodeoxyglucose (18f-fdg) positron emission tomography (pet) will be performed in parallel to metabolomic analyses of tumour tissue. the investigators will correlate changes in imaging bio-markers to corresponding changes in tissue or blood bio-markers by repeated imaging and biopsies for better understanding of the image parameters. the data from the two assessments will be used for identifying imaging bio-markers, predictive for outcome. the patient data will be divided into one set of data for hypothesis generation and another set for validation.

Eligibility criteria:
inclusion criteria: 1. morphologically (pathology or cytology) verified, previously untreated squamous cell carcinoma (scc) of the oral cavity, oropharynx, uterine cervix, oesophagus or lung. 2. the patient should be planned for treatment with radiotherapy alone or in combination with concomitant medical therapy 3. the tumour shall be radiologically and/or visually identifiable and accessible for biopsy without the need for general anaesthesia or other major interventions 4. the patient must be at least 18 years of age, able to understand the given information and, leave a written informed consent to participate exclusion criteria: 1. the patient is unwilling to participate in the study 2. patients with adjuvant post-operative radiotherapy (i.e. no visible remaining tumour) 3. pregnancy or lactation 4. contraindications to investigations with mri, gadolinium contrast or pet-tracers 5. patients with an estimated glomerular filtration rate (gfr) \<60 ml/min/1.73m2. 6. severe co-morbidities that are judged to significantly compromise survival in a two-years perspective.
neuroprotection via optimizing cerebral blood flow after cardiac arrest (neuro-intact) study

Conditions: Out-Of-Hospital Cardiac Arrest (OHCA)

Summary: this single-center proof of concept study aims to assess the efficacy of a blood pressure strategy targeting person- and time-specific cerebral blood flow compared with standard-of-care using neuron-specific enolase as a quantitative biomarker of brain injury. our central hypothesis is that an individualized blood pressure strategy targeting cerebral perfusion will reduce the extent of brain injury as indicated by changes in levels of neuron-specific enolase from baseline at 72 hours. to test this hypothesis, we will recruit 49 patients to an individualized blood pressure management strategy targeting cerebral blood flow, where optimal blood pressure will be serially calculated by the icm+ brain monitoring software (cambridge, uk) using inputs from transcranial doppler ultrasound and near-infrared spectroscopy.


Eligibility criteria:
inclusion criteria: 1. at least 21 years of age 2. comatose defined as not being able to obey verbal commands and no verbal response to pain after sustained rosc. exclusion criteria: 1. ≥ 80 years old at time of enrolment 2. pregnant patients 3. limitations of care or life support therapy withdrawn within 24 hours of admission
cabazitaxel in platinum refractory ovarian cancer

Conditions: Ovarian Cancer

Summary: ovarian cancer patients are considered platinum refractory if their disease worsens during primary platinum treatment or if they have no effect of the treatment. this constitutes a major therapeutic problem and new treatment approaches are highly needed. cabazitaxel (jevtana®) is a new taxane with effect in breast and prostatic cancer. in both tumors it has effect in patients refractory to taxotere. consequently, it could be anticipated that cabazitaxel may have an effect in platinum refractory ovarian cancer.


Eligibility criteria:
inclusion criteria: * histologically confirmed epithelial, primary fallopian or primary peritoneal cancer. stages i-iv. * patients with refractory disease defined as progression or no change during primary treatment, as evaluated after 3 and/or 6 cycles of platinum/paclitaxel. prior to inclusion, patients must have received platinum and paclitaxel as combination treatment. * measurable disease by response evaluation criteria in solid tumors (recist) 1.1 or evaluable by gynecologic cancer interest group (gcig) cancer antigen 125 (ca-125) criteria. * age ≥ 18 years. * performance stage 0-2. * adequate bone marrow function, liver function, renal function, and coagulation parameters (within 7 days prior to inclusion): 1. neutrophils (anc) ≥ 1.5 x 10\^9/l 2. platelet count ≥ 100 x 10\^9/l 3. serum bilirubin ≤ 1.0 x upper limit of normal (uln) 4. serum transaminase ≤ 2.5 x uln 5. serum creatinine ≤ 1.5 uln. if creatinine 1.0 - 1.5 x uln, creatinine clearance will be calculated according to the chronic kidney disease epidemiology collaboration formula (ckd-epi)and patients with creatinine clearance \<60 ml/min should be excluded * written informed consent. exclusion criteria: * history of severe hypersensitivity reaction (≥grade 3) to taxol. * history of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing drugs. * concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome p4503a4/5 (a one week wash-out period is necessary for patients who are already on these treatments). * neuropathy grade ≥ 2. * pregnant or breast-feeding patients. for fertile women a negative pregnancy test at screening is mandatory. * fertile patients not willing to use effective methods of contraception during treatment and for 6 months after the end of treatment. * other malignant diseases within 5 years prior to inclusion in the study, except basal cell or squamous cell carcinoma of the skin and cervical carcinoma-in-situ. * other experimental therapy or participation in another clinical trial within 28 days prior to treatment initiation. * history of any chronic medical or psychiatric condition or laboratory abnormality that is not medically controlled or in the opinion of the investigator may increase the risks associated with study drug administration. (e.g. diabetes, cardiac diseases, hypertension, renal, thyroid or liver disease). * vaccination with yellow fever vaccine or any live attenuated vaccine during the treatment. * treatment with disulfiram (antabuse)

Keywords: ovarian cancer platinum refractory
collaborative consultation for participation among students with idd

Conditions: Mental Retardation and Developmental Disabilities With Organic Condition

Summary: objective: developing and corroborating the collaborative consultation for participation of students with intellectual disability (co-pid) program, for enhancing classroom participation among students with moderate intellectual and developmental disability (idd). method: study took place in two special education schools and included students with moderate idd (n=60) and their teachers (n=11). the settings were randomly assigned to intervention or control group. in the intervention group, co-pid program was employed; in the control group an in-service (is) was employed. participation was evaluated at pre-test and post-test.

the study was conducted in three phases: (a) pre-test; (b) intervention; and (c) post-test pre-test. using the 'structured observation of students' participation in class', each student in both groups was observed four times during different lessons (with a 1-week interval between observations) to establish a baseline for level of participation. all pre-test observations were conducted between the 2nd and 3rd months of the school year, by an occupational therapist with 8 years of experience working with children with developmental delays. the observer was trained in using the 'structured observation of students' participation in class' and was not blinded to the schools' assignment (co-pid or is). during this period the teachers, who were blinded to the school assignment, were asked to teach in a regular manner without changing the content or design of their lessons. next, the teachers filled out the school function assessment questionnaire for each student. finally, based on the 'structured observation of students' participation in class' scores and teachers' familiarity with the students' function, the occupational therapist and each of the participating teachers jointly filled-out the 'goal attainment scaling' form. each student had three goals, one for each of the participation skills: communicating, choosing and initiating. post-test. this phase was conducted during the 9th and 10th months of the school year, and was identical to the pre-testing phase in terms of both process and measures used

Eligibility criteria:
inclusion criteria: 1. a diagnosis of moderate idd 2. mobility independence 3. no secondary diagnosis of autism, nor sensory disabilities such as blindness or deafness 4. students had been studying at the school for at least one year prior to data collection. exclusion criteria: -

Keywords: intellectual disability collaborative consultation participation
a study to evaluate the pharmacokinetics and the safety after administration of br1015 and co-administration of br1015-3 and br1015-2 under fed conditions

Conditions: Essential Hypertension

Summary: the purpose of this clinical trial is to evaluate the pharmacokinetics and the safety after administration of br1015 and co-administration of br1015-3 and br1015-2 in healthy volunteers under fed conditions


Eligibility criteria:
inclusion criteria: * those weigh 50 kg or more and have body mass index (bmi) within the range of 18.0 to 30.0kg/m2 at screening visit. * those who sign written consent spontaneously after listening to and understanding sufficient explanation of the purpose and contents of this clinical trial, characteristics of the investigational products, expected adverse events, etc. * those who agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using methods of contraception accepted in clinical trial\*(except for hormone drugs) from the date of consent to 14 days after the last administration and disagrees to provide their sperm or ovum. * methods of contraception accepted in clinical trial: combined use of non hormonal intrauterine device, vasectomy, tubal ligation, and barrier methods (male condom, female condom, cervical cap, contraceptive diaphragm, sponge, etc.) or combined use of two or more barrier methods if spermicide is used. exclusion criteria: * those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 30 days prior to the first day of administration or have taken drugs concerned about affecting this clinical trial within 10 days prior to the first day of administration. (however, participation is possible considering pharmacokinetics and pharmacodynamics such as interaction of investigational products, half-life of concomitant drugs, etc.) * those who have participated in other clinical trials(including bioequivalence tests) and administered their investigational products within 6 months prior to the first administration date.(however, the termination for participation in other clinical trials are based on the last administration date of their investigational products) * those who have a medical history of gastrointestinal resection or gastrointestinal diseases that may affect the absorption of drugs. (except for simple appendectomy, hernia surgery) * those who can't discontinue a diet (ex. raw grapefruit, grapefruit juice or food containing grapefruit, etc.) that may affect the absorption, distribution, metabolism, and excretion of the drug within 48 hours prior to the first day of administration. * in the case of a female subject, those suspected pregnancy, pregnant woman, lactating woman.
safety of immediate weight-bearing as tolerated after well-reduced geriatric hip

Conditions: Bony Weight Bearing Disorder

Summary: purpose: proximal femur fracture is a major traumatic injury in elderly populations; however, practical postoperative weight-bearing protocols are lacking. therefore, the purpose of the present study was to investigate whether early weight-bearing status after proximal femur nail fixation is associated with any loss of reduction and evaluate the clinical outcomes of this intervention. patients and methods: for this prospective single center clinical trial study, we recruited 14 proximal femur fracture cases, classified by ao/ota 2018, receiving intramedullary nail fixation. clinical outcomes included the harris functional hip score and vas pain score. additionally, demographic data, radiological parameters, time to weight-bearing, mortality rate, medical and surgical complications, and final ambulation status were recorded.


Eligibility criteria:
inclusion criteria: * patients with ao/ota type 31 fractures were included, and all fractures were classified using intraoperative fluoroscopy with traction on the fracture table. exclusion criteria: * patients with pathological fractures, neurovascular insufficiency, ipsilateral lower extremity musculoskeletal injury, multiple fractures, or high risk of falling, including frequent falling accidents within 6 months, unsteady gait, ipsilateral neuropathy, limb weakness, and urinary incontinence were excluded.

Keywords: fracture reduction proximal femur fracture geriatrics
use of febuxostat in hyperuricemia among hemodialysis patients

Conditions: Hyperuricemia; Hemodialysis Complication

Summary: hyperuricemia is not infrequently encountered among hemodialysis patients. however, there is no clear data about use of febuxostat among hemodialysis patients, apart from very small case series. the aim of this study is to investigate the efficacy of using febuxostat for the treatment of hyperuricemia among hemodialysis patients.


Eligibility criteria:
inclusion criteria: * age above 18 years * hemodialysis patient * hyperuricemia (uric acid level above 6.0 mg/dl in females and 7.0 mg/dl in males) exclusion criteria: * patient currently and/or recently received drugs for hyperuricemia within the last three months * patient had recent (within 3 months) change of erythropoiesis stimulating drugs or other drug known to increase uric acid e.g furosemide
validation of the facial and cephalic pain inventory

Conditions: Sinusitis

Summary: this study proposes to develop and validate a new instrument designed to measure facial and nasal discomfort related to chronic sinusitis. the second phase of the study will be to use this instrument to measure correlation with sinus computed tomography (ct) scans.

the following specific aims will be addressed: * to create a user-friendly, self-explanatory instrument (face pain questionnaire) with pain severity visual analog scales associated with the common locations of facial pain in chronic sinusitis. * to evaluate the clinimetric reliability and validity of the face pain questionnaire * to evaluate the ability of th face pain questionnaire to detect change in symptoms following medical or surgical treatment * to quantify a minimally important difference in the face pain instrument by correlating disease-specific quality of life change (transition scale) with face pain rating changes following treatment. * to evaluate the correlation between facial pain symptoms described on the face pain questionnaire with ct scan and endoscopic findings. the measurements used for the study are: demographics (age, gender and race), contact information (to facilitate mailing of future instruments), sinonasal outcome test-20 (snot-20 - a well validated, 20-item measure of rhinosinusitis specific qol), facial and cephalic pain inventory (instrument under study) and translational quality of life form (this transition scale provides a subjective quantification of the degree of change in quality of life from sinusitis); ct scans and nasal endoscopy findings. control subjects will complete the snot-20 (validated qol form) and the face pain a single time. case subjects will complete the snot-20 and the face pain questionnaire at the visit during which they review their ct results with the md. thereafter, they will complete the face pain questionaire twice more; at weeks 12 and 14 post that visit. they will also complete the transition scale at week 12. these forms will be mailed to the subjects and returned by mail. we hypothesize that facial pain ratings will correlate moderately with snot-20 scores and a transition scale. higher values are not expected because qol instruments encompass many symptoms of chronic sinusitis, but the face pain instrument addresses location and severity of pain. we will also test the hypothesis that facial pain ratings will be much lower in non-sinusitis patients.

Eligibility criteria:
inclusion criteria: * case subjects from the rhinology clinic must have ct evidence of chronic sinusitis * control subject from the otology clinic who have not had sinus surgery in the past 2 months exclusion criteria: * any subject unable to give informed consent of complete self-administered questionnaires written in english * control subjects with a history of sinusitis in the last 6 months

Keywords: chronic sinusitis facial pain
adalimumab biosimilar in clinical practice

Conditions: Psoriasis

Summary: this is an observational, retrospective, multicenter, and descriptive study of patients treated with adalimumab biosimilar for psoriasis, according to clinical practice. existing data will be collected from the dermatology services database of the hospitals participating in the study, from the medical histories of all treated patients who meet the inclusion criteria and sign informed consent. the aim of the study is to determine the effectiveness of the different adalimumab biosimilars in clinical practice.

adalimumab is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic treatment. there are currently several biosimilar drugs (amgevita, imraldi, hyrimoz, idacio, hulio,...) in addition to the reference product (humira). the reduction in the cost of production of biosimilar drugs with respect to reference products has led to their replacement by biosimilar drugs in patients initiating biological therapy, but some centers are also switching to adalimumab biosimilar in patients who are controlled with original adalimumab (humira). there are no actual clinical efficacy / safety data in our setting on the use of adalimumab biosimilars. there is also no evidence of maintenance response in patients who are switched from adalimumab (humira) to biosimilar adalimumab in clinical practice. this retrospective study will collect demographic and disease data of the psoriasis patient treated with the different biosimilars of adalimumab, as well as their comorbidities, response to treatment, and safety. in this way, data will be available in usual clinical practice to improve the management of the patient with psoriasis treated with biosimilar drugs.

Eligibility criteria:
inclusion criteria: * patients of both sexes who have received treatment with adalimumab and who have signed an informed consent. exclusion criteria: * refusal to participate. * any other cause of exclusion based on clinical criteria and the technical data sheet of the drug.