Kornimate/medical-research-clean huggingface dataset:
closure of protective ileostomy 2 vs. 12 weeks after tme

Conditions: Rectal Cancer

Summary: the purpose of this study is to compare the feasibility, safety, and quality of life (qol) in patients (pts) undergoing protective ileostomy closure after 2 weeks with a closure after 12 weeks.

in three surgical departments between 2007 and 2013, 72 pts with total mesorectal excision and coloanal or low colorectal anastomosis for rectal cancer were randomly assigned to closure of their protective ileostomy after 2 weeks (group a, 37 pts) or 12 weeks (group b, 35 pts). one day before planned stoma closure, the coloanal/colorectal anastomosis was checked by palpation, contrast enema via ileostomy and, in case of hazards, by proctoscopy. perioperative data was assessed prospectively using numeric values, visual analogue scales (vas, 0 = lowest value, 100 = highest value) and qol-index (gqli, max. 144 points). complications were recorded prospectively.

Eligibility criteria:
inclusion criteria: * anastomosis ≤ 5cm from anal verge * age \>18 years * informed consent * uneventful course after first operation exclusion criteria: * pregnancy * allergy to contrast agent * severe non-surgical complications * evident abdominal - pelvic complications

Keywords: quality of life feasibility safety protective ileostomy closure
focused stereotactic radiation treatment of prostatic adenocarcinoma

Conditions: Prostate Cancer

Summary: focused stereotactic radiation treatment of localized prostatic adenocarcinoma. in order to quantify the delay between the focused treatment and the salvage procedure.

focused stereotactic radiation treatment of localized prostatic adenocarcinoma. in order to quantify the delay between the focused treatment and the salvage procedure. second objectives : objectives: prostate-specific antigen (psa) response, mri response, toxicity (ctcaev4), quality of life (international prostate symptom score (ipss) and the international index of erectile function (iief5) scores). method at first: multiparametric magnetic resonance imaging (mri) - 12 biopsies within the whole gland. placement under endorectal ultrasound control of 4 fiducials at least 2 cm spaced. treatment : cyberknife radiation treatment delivering 36.25 gy in 5 fractions, in 10 days. tracking using the 4 fiducials. critical organs: rectal and bladder wall: v35\<2cc. bladder neck and urethra: v35\<1cc. salvage treatments: in such a context, salvage surgery or salvage intensity modulation radiation therapy (imrt) treatments can in theory remain valid and safe options.

Eligibility criteria:
inclusion criteria: * prostatic adenocarcinoma of capra score≤2 invading no more than two adjacent of the 12 prostatic zones. lesions\>3mm. maximal urinary flow rate ≥ 10ml/s, mean flow rate ≥ 5ml/s, post micturation volume ≤80ml, ipss score ≤15. exclusion criteria: * systemic disease, ulcerative hemorrhagic ulcer or crohn diseases, bladder neck stenosis, urethral implants, transurethral prostatectomy (turp), any recurrent prostatitis within the last 3 years.

Keywords: prostate cancer good prognosis focused treatment cyberknife
clinical characteristics of spinal levobupivacaine: hyperbaric compared with isobaric solution

Conditions: Observation of Neuromuscular Block; Disease (or Disorder); Gynecological

Summary: the authors would like to investigate the blocking characteristics, surgical quality and side effects of intrathecal levobupivacaine whether there are any differences between the hyperbaric and the isobaric formulation for gynaecologic surgeries which need higher block level than the urological surgeries.

the investigators study in the similar patients, give the same intervention except the baricity of levobupivacaine. the investigators record the level of sensory block and modified bromage score for motor blockade.

Eligibility criteria:
inclusion criteria: * asa i-iii, aged 18-70 yr, scheduled for elective gynaecologic surgery, (total abdominal hysterectomy (tah), tah with uni-/bilateral salpingo-oophorectomy (so), uni-/bilateral ovarian cystectomy, or myomectomy exclusion criteria: * contraindications for spinal block, body mass index (bmi) more than 35 kg/m2 and height less than 150 cm

Keywords: abdominal incision hyperbaric isobaric levobupivacaine spinal anaesthesia
safety and activity study of her2-targeted dual switch car-t cells (bpx-603) in subjects with her2-positive solid tumors

Conditions: HER-2 Gene Amplification; HER2-positive Gastric Cancer; HER2-positive Breast Cancer; HER-2 Protein Overexpression; Solid Tumor, Adult

Summary: this is a phase 1/2, open-label, multicenter, non-randomized study to investigate the safety, tolerability, and clinical activity of her2-specific dual-switch car-t cells, bpx-603, administered with rimiducid to subjects with previously treated, locally advanced or metastatic solid tumors which are her2 amplified/overexpressed.

* phase 1: cell dose escalation to identify the maximum dose of bpx-603 administered without or with rimiducid. the first subject in each dose cohort will receive bpx-603 alone (without rimiducid) in order to assess safety of the car-t monotherapy. * phase 2: indication-specific dose expansion to assess the safety, pharmacodynamics (including bpx-603 persistence and response to temsirolimus as applicable), and clinical activity at the recommended dose for expansion (rde) identified in phase 1 in various her2+ solid tumors. * during phase 1 or 2, temsirolimus (single iv dose at 25 mg) may be administered following bpx-603 infusion in response to treatment-emergent toxicity in order to activate the irc9 safety switch.

Eligibility criteria:
inclusion criteria: * documented evidence of her2 amplification/overexpression by local testing. * histologically or cytologically confirmed diagnosis of a locally advanced unresectable or metastatic her2+ solid tumor malignancy for which standard treatment is no longer effective, does not exist, or subject is ineligible. * subjects with a solid tumor malignancy for which her2-targeted therapy is approved as a standard treatment (e.g., breast, gastric cancers) must have received prior treatment with approved her2-directed therapy. * measurable disease (at least one target lesion) per recist v1.1. * life expectancy \> 12 weeks. * ecog 0-1. * adequate organ function. exclusion criteria: * symptomatic, untreated, or actively progressing central nervous system metastases. * prior car t cell or other genetically-modified t cell therapy. * impaired cardiac function or clinically significant cardiac disease. * symptomatic intrinsic lung disease or those with extensive tumor involvement of the lungs. * severe intercurrent infection. * pregnant or breastfeeding. * known hiv positivity.

Keywords: her2 car-t breast cancer solid tumors gastric cancer
hyaluronic acid gel in prevention of intrauterine adhesions after endometrial ablation

Conditions: Menorrhagia

Summary: the aim of the study is to evaluate if hyaluronic acid gel prevents intrauterine adhesion formation after endometrial thermal ablation.


Eligibility criteria:
inclusion criteria: * menorrhagia exclusion criteria: * abnormal uterine cavity, * abnormal endometrial biopsy
natural history of carotid atherosclerosis

Conditions: Carotid Artery Disease; Stroke; Myocardial Infarction; Angina Pectoris

Summary: a prospective study of 700 patients with coronary artery disease will undergo non invasive evaluation of their carotid arteries by ultrasound and microwave radiometry. the patients will be followed up for 3 years and their outcome regarding the cardiovascular events (death, cardiac events, cerebrovascular events) will be recorded

carotid artery thermal heterogeneity recorded by mr will be corelated to cardiovascular events (death, cardiac events, cerebrovascular events) as well as to all demographic (age, sex, hypertension, dyslipidemia, smoking status, etc) factors

Eligibility criteria:
inclusion criteria: * consecutive patients with coronary artery disease admitted in our hospital exclusion criteria: * patients with history of previous cerebrovascular event, * history of vasculitis, intermittent inflammatory, infectious, or neoplastic conditions likely to be associated with an acute-phase response.

Keywords: microwave radiometry cardiovascular events carotid artery disease stroke myocardial infarction
pmcf study on the safety, performance and clinical benefits of the dvr plating system

Conditions: Distal Radius Fracture; Distal Ulna Fracture; Osteotomy

Summary: the study is a single-center, retrospective, non-randomized, non-controlled and consecutive series post-market study. the purpose of this study is to confirm safety, performance and clinical benefits of the dvr plates. the primary objective is the assessment of performance by analyzing fracture healing. the secondary objective is the assessment of safety by recording and analyzing the incidence and frequency of complications and adverse events. patients' outcomes will also be assessed.

the dvr plating system in this study includes the dvr crosslock distal radial plate, the dvr volar rim plate and the dvr wrist plates. one site will be involved in this study. the aim is to include a total of 112 consecutive series patients treated between 2014 and 2018. all potential study subjects will be required to participate in the informed consent process. baseline data from the preop, intraop, immediate post-op and last consultation visit will be available in medical notes and collected retrospectively. during a follow up phone call the patient will be asked to complete a patient questionnaire and a question on his/her wrist function. in addition, any complications since the last consultation visit at the clinic, information about and treatment of the complications will also be collected over the phone.

Eligibility criteria:
inclusion criteria: * all subjects must have been implanted with one of the dvr plates according to the approved indications. exclusion criteria: * off-label use. * cases where there is an active infection. * conditions which tend to retard healing such as, blood supply limitations, previous infections, etc. * insufficient quantity or quality of bone to permit stabilization of the fracture. * conditions that restrict the patient's ability or willingness to follow postoperative instructions during the healing process. * foreign body sensitivity - where material sensitivity is suspected, appropriate tests should be conducted and sensitivity ruled out prior to implantations. * cases where the implant(s) would cross open epiphyseal plates in skeletally immature patients. * cases with malignant primary or metastatic tumors which preclude adequate bone support or screw fixations, unless supplemental fixation or stabilization methods are utilized.

Keywords: medical device performance safety clinical benefits post-market clinical follow-up study
cetuximab plus p-hdfl for the first-line treatment of advanced gastric cancer

Conditions: Gastric Cancer

Summary: the investigators have initial evidence that the combination of cetuximab and cisplatin-hdfl may further improve the efficacy of the cisplatin-hdfl combination chemotherapy.

the clinical efficacy (confirmed objective response rates, progression-free survival, overall survival), and treatment-related toxicities of this novel regimen will be examined as the first-line treatment in patients with nonresectable or recurrent/metastatic gastric cancer.

Eligibility criteria:
inclusion criteria: 1. age 18 to 75 years 2. histologically proven adenocarcinoma 3. at least one "measurable" lesion (by recist) 4. no prior chemotherapy for gastric cancer 5. who performance status ≦ 2 6. adequate baseline organ functions 7. fasting serum triglyceride level \> 70 mg/dl 8. written informed consent 9. at least one month from gastrectomy 10. availability of tumor sample for immunohistochemical or pharmacogenomic testing of egfr exclusion criteria: 1. concomitant anti-cancer biological agents, chemotherapy, or radiotherapy 2. cns metastasis 3. pregnancy, breast-feeding women and women of child-bearing potential 4. life expectancy less 3 months 5. serious concomitant illness 6. concurrent or prior second malignancy 7. known hypersensitivity reaction to any of the components of study treatments

Keywords: combination chemotherapy gastric cancer
covid-19 data analyses in brazil

Conditions: Covid

Summary: this descriptive study aims to describe the brazilian scenario of patients hospitalized due to covid-19 and to analyze the impact of covid-19 on the brazilian public health system. data will be extracted from the largest secondary database of the brazilian public health system, datasus ("departamento de informática do sistema único de saúde"), responsible for collecting, processing, analyzing and disseminating health information and statistics in the country. the analysis, performed only on patients hospitalized during the hospitalization episode, will also evaluate the impact of vaccination against covid-19 on the immunocompromised population compared to the general population.

this is an observational, retrospective, descriptive study based on a secondary database from the brazilian public health system. data were collected from three public databases in a large system (datasus). these databases are srag ("síndrome respiratória acuta"), sih ("sistema de informação hospitalar"). all data collected are de-identified, which does not allow the identification of sensitive data of participants. the population of this study would be representative of a significant sample of individuals present in the health records system registered with covid-19. the data included in this study were acquired between january 2021 and december 2023. this analysis will not include data from specific vaccine brands. the data described refer only to the episode of hospitalization related to covid-19. the primary objective is to describe the demographic and clinical characteristics of individuals hospitalized for covid-19 between january 2021 and december 2023, stratified by underlying ci, number of vaccine doses received, age, and period of the predominant variant. as a secondary objective, it is to describe in-hospital mortality due to covid-19 among individuals hospitalized for covid-19 between january 2021 and december 2023, stratified by underlying ci, number of non-ci comorbidities, number of vaccine doses received, age, and period of the predominant variant. and also as an exploratory objective, it is expected to describe the use of hospital healthcare resources (hcru) and the costs associated with hospitalizations related to covid-19 between january 2021 and december 2023.

Eligibility criteria:
inclusion criteria: * all individuals with covid-19-related hospitalization. individuals aged ≥18 years at the time of entry into the database. exclusion criteria: * hospitalized patients with incomplete or missing data related to data linked in datasus.

Keywords: covid
impact of basophobia on balance and functional outcomes in patients with stroke

Conditions: Stroke, Ischemic; Stroke Hemorrhagic; Balance

Summary: several studies have reported that the physical functions associated with falls, including motor performance, postural balance, flexibility, and muscle strength, are also associated with fof. patients with stroke have trouble performing adls, including washing their face, eating, bathing, dressing, toileting, and walking, which also affect fof. anxiety and depression are common affective disorders in patients with stroke and significantly increase fof .

people who are afraid of falling because they can't keep their balance can utilize this makes them less susceptible to fall and high tendency to prevent it.

Eligibility criteria:
inclusion criteria: an ischemic stroke and having had the disease for longer than three months have frequent falling, having sufficient cognition (as measured by a montreal cognitive assessment score of over 26) and having upper and lower extremity spasticity ranging from (grade 1+: 2) on a modified ashworth scale exclusion criteria ) musculoskeletal issues, such as severe arthritis, total hip arthroplasty, knee surgery, lower extremity fractures within the previous six months, or contractures brought on by a fixed deformity and/or disparity in leg length, 2) instable medical conditions (e.g., unstable angina, recent myocardial infarction, history of congestive heart failure, major heart valve problems, or unstable hypertension);

Keywords: fear of falling, balance, stroke
assessment of a drama workshop program for immigrant and refugee adolescents

Conditions: Learning Disabilities

Summary: the purpose of this study is to determine whether a drama workshop program for immigrant and refugee youth is effective in reducing impairment in high school students presenting learning difficulties.


Eligibility criteria:
inclusion criteria: * all students who are assigned to special classes based on behavioural or learning problems in grades 7-10 in the participating schools will participate in the program and be included in the study if they and their parents consent to in the research. exclusion criteria: * more severe cases

Keywords: dramatherapy group tutoring activities impairment emotional and behavioural problems learning difficulties
improving outcomes in peritoneal dialysis

Conditions: Chronic Kidney Disease; Peritoneal Dialysis Access

Summary: the objective is to understand the best way to place peritoneal dialysis (pd) catheters, and the best way to collect data regarding their function in england, wales and northern ireland. phase 1: we will carry out a detailed examination of existing returned pilot data with emphasis on data fields with poor data completeness and perform root cause analysis, and assess deficiencies in data field definition to identify improvements to be implemented. we will construct and disseminate electronic survey material to all study centres with targeted visits by the principle investigator undertaken. these visits will facilitate insight into local organization of data collection including interaction with designated individuals responsible for data returns. pd training days will be organized with emphasis on clinical practice feedback utilizing data acquired in the initial phases. hospital episode statistics will be linked to existing acquired pd patient information to ensure the accuracy of collected data. an online data acquisition system will be developed to allow direct data entry from centres. phase 2: on-going and sustained data acquisition performed on a prospective basis. phase 3: primary data analysis including clinical practice variation in england, wales and northern ireland to identify site specific pd catheter functionality variation. additionally, patient and site specific characteristics that predict clinical outcomes in pd will be identified and characterised. phase 4: clinical guidelines will be developed.


Eligibility criteria:
inclusion criteria: * any adult (16 years or over) patient requiring first pd catheter placement exclusion criteria: * patient less than 16 years

Keywords: chronic kidney disease peritoneal dialysis access peritoneal dialysis catheter catheter function
vitamin d deficiency in chronic kidney disease (ckd) patients

Conditions: Secondary Hyperparathyroidism; Chronic Kidney Disease

Summary: this is an open label, single center, randomized, active comparator controlled study, comparing the effects of vitamin d replacement using oral ergocalciferol versus paricalcitol on parathyroid hormone (pth) levels in patients with stage 3 and 4 ckd and vitamin d deficiency or insufficiency. the purpose of this study is to determine which of these two approaches is more successful.

this study will enroll chronic kidney disease patients, stage 3 and 4, who have low serum vitamin d levels as defined by k doqi guidelines. patients will be randomized to receive oral daily ergocalciferol or paricalcitol. a total of 80 patients will be enrolled, 40 in the cholecalciferol group and 40 in the paricalcitol group. outcomes will be assessed as proportion of patients achieving pre-defined changes from baseline and as absolute changes from baseline values. baseline values will be determined from averaging two consecutive measurements of the variables of interest prior to randomization.

Eligibility criteria:
inclusion criteria: 1. male or female chronic kidney disease patients at least 18 years of age. 2. patients should be able and willing to provide written informed consent and hipaa authorization. 3. chronic kidney disease stage 3 or 4. 4. plasma intactpth level above 75pg/ml. 5. serum 25 ohd level below 30ng/ml. 6. negative pregnancy test unless 2 years postmenopausal or with a documented tubal ligation or total hysterectomy. 7. patients need to be off of any vitamin analogues or preparations for 4 weeks prior to screening. exclusion criteria: 1. women who are breast feeding, pregnant, capable of becoming pregnant, and not participating in an acceptable form of birth control. 2. patients currently participating in a clinical trial with another investigational drug or device or who have receive an investigational drug or device within 30 days of enrollment in this study. 3. major surgery within one month prior to enrollment or planned surgery while patient is in study (other than dialysis vascular access surgery). 4. patients who have had a malignancy unless they have received curative treatment and have been disease free for 2 years. 5. patients with a medical status that the pi decides would preclude participation. 6. patients on hemodialysis or peritoneal dialysis. 7. patients with a functional renal transplant. 8. patients with allergies to study drugs. 9. patients with acute renal failure with the past 12 weeks. 10. patients with clinically significant gastrointestinal or liver disease. 11. patients with active granulomatous disease. 12. patients with urine calcium:creatinine ratio of more than 0.2. 13. patients who received vitamin d analogs, calcimimetics, or biphosphonates within 4 weeks before screening. treatment with any one of these medicines during the study is not permitted.

Keywords: calcium vitamin d deficiency chronic kidney disease