Kornimate/medical-research-clean huggingface dataset:
a feasibility study on adaptive 18f-fdg-guided radiotherapy for recurrent and second primary head and neck cancer in the previously irradiated territory.

Conditions: Re-irradiation in Recurrent and Second Primary Head and Neck Cancer

Summary: adaptive dose painting appears to increase the chance of cure at minimized radiation-induced toxicity in intensity-modulated radiotherapy (imrt) for primary head and neck cancer. this could also be of importance in imrt for recurrent and second primary head and neck cancers in previously irradiated territory. this trial investigates the feasibility of continuous adaptive 18f-fluorodeoxyglucose-positron emission tomography-voxel (\[18f\]fdg-pet-voxel) intensity-based imrt in reirradiation of patients with recurrent and second primary head and neck cancer.


Eligibility criteria:
inclusion criteria: * histologically confirmed recurrences and second primary squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx in the previously irradiated territory. * primary unresectable tumor and/or patients refused surgery. * no grade 3 or more late toxicity (except xerostomia) after the initial radio(chemo)therapy for primary head and neck cancer. * minimal interval 12 months after the initial radio(chemo)therapy for primary head and neck cancer. * decision of a multidisciplinary tumor board on curative radiotherapy (in combination or not with targeted therapy with cetuximab) * karnofsky performance status ≥70%. * age ≥ 18 years old. * informed consent obtained, signed and dated before specific protocol procedures. exclusion criteria: * previous radiotherapy for ct1-2 cn0 m0 glottic cancer. * brachytherapy as treatment for second primary / recurrence. * distant metastases. * other second primary tumors that are not under control. * pregnant or lactating women. * elevated blood creatinine level. * allergy to the ct-contrast agents. * mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study. * patient unlikely to comply with protocol, i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study.
vulvodynia pain thresholds

Conditions: Vulvodynia

Summary: annotated pain maps will be created showing region and size of areas sensitive to mechanical stimulus in both women affected by vulvar pain and unaffected control patients.

the investigators will develop annotated pain maps showing region and size of areas sensitive to mechanical stimulus. the pain maps will be created by combining ir images, photographs, and clinical input, and will be correlated with patient co-morbidities. the ir images will assess for areas of inflammation and increased skin temperature. pain maps will be created with patient response to mechanical stimulation with a cotton swab and will be overlaid on the thermographic images. through this combination of measurements, the investigators plan to expand the diagnostic tools used in patient care as well as on the classification of this heterogeneous disorder.

Eligibility criteria:
inclusion criteria: * women meeting criteria for vulvodynia women seeking care for routine gynecologic exam exclusion criteria: * women less than 18 years of age current pregnancy women with vulvar or vaginal disorder other than pain
evidence-based stimulation trial with human rfsh in europe and rest of world 1

Conditions: Infertility

Summary: this trial investigates the effects of fe 999049 compared to gonal-f.


Eligibility criteria:
inclusion criteria: * informed consent documents signed prior to screening evaluations * in good physical and mental health * pre-menopausal females between the ages of 18 and 40 years * infertile women diagnosed with tubal infertility, unexplained infertility, endometriosis stage i/ii or with partners diagnosed with male factor infertility, eligible for in vitro fertilisation (ivf) and/or intracytoplasmic sperm injection (icsi) using fresh or frozen ejaculated sperm from male partner or sperm donor * infertility for at least one year before randomisation for subjects ≤37 years or for at least 6 months for subjects ≥38 years (not applicable in case of tubal or severe male factor infertility) * the trial cycle will be the subject's first controlled ovarian stimulation cycle for ivf/icsi * hysterosalpingography, hysteroscopy, saline infusion sonography, or transvaginal ultrasound documenting a uterus consistent with expected normal function (e.g. no evidence of clinically interfering uterine fibroids defined as submucous or intramural fibroids larger than 3 cm in diameter, no polyps and no congenital structural abnormalities which are associated with a reduced chance of pregnancy) within 1 year prior to randomisation * transvaginal ultrasound documenting presence and adequate visualisation of both ovaries, without evidence of significant abnormality (e.g. no endometrioma greater than 3 cm or enlarged ovaries which would contraindicate the use of gonadotropins) and normal adnexa (e.g. no hydrosalpinx) within 1 year prior to randomisation. both ovaries must be accessible for oocyte retrieval. * early follicular phase (cycle day 2-4) serum levels of fsh between 1 and 15 iu/l (results obtained within 3 months prior to randomisation) * body mass index (bmi) between 17.5 and 32.0 kg/m2 (both inclusive) at screening exclusion criteria: * known endometriosis stage iii-iv * one or more follicles ≥10 mm observed on the transvaginal ultrasound prior to randomisation on stimulation day 1 * known history of recurrent miscarriage (defined as three consecutive losses after ultrasound confirmation of pregnancy (excl. ectopic pregnancy) and before week 24 of pregnancy) * known abnormal karyotype of subject or of her partner/sperm donor, as applicable, depending on source of sperm used for insemination in this trial. * any known clinically significant systemic disease (e.g. insulin-dependent diabetes) * any known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) which can compromise participation in the trial with the exception of controlled thyroid function disease * known tumours of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus which would contraindicate the use of gonadotropins.
evaluation and correlation of serum fetuin-a levels in periodontal health and disease: a clinico-biochemical study

Conditions: Gingivitis and Periodontal Diseases

Summary: the present clinico-biochemical study was carried out to estimate the levels of fetuin a and mmp7 in serum of systemically healthy subjects in periodontal health and disease and to evaluate the impact of periodontal interventional therapy (scaling and root planing) on the same.

sixty sex-matched subjects (30 males and 30 females) belonging to a common age group (30-39 yrs) were enrolled for the study to eliminate bias from confounding factors. they were divided into three groups consisting of 20 subjects in each group based on the clinical and radiological parameters; periodontally healthy (group i), chronic gingivitis (group ii) and chronic periodontitis ( group iiia) from whom serum samples were collected. the group iiib further comprised of the subjects from group iiia, who had received non-surgical periodontal therapy (scaling and root planing). serum samples were collected at baseline and at 12 weeks post therapy. fetuin a and mmp-7 concentration was determined from serum samples of patients using elisa. the results of our study depicted that fetuin a concentration negatively correlates, whereas, mmp7 positively correlates with the extent of periodontal inflammation. further, periodontal therapy demonstrated a significant increase in serum fetuin a and decrease in mmp 7 levels establishing the influence of periodontal therapy in stabilizing their levels.

Eligibility criteria:
inclusion criteria: 1. age group of 30-39 years. 2. systemically healthy subjects. 3. patient who are co-operative and able to attend follow up. 4. patient who have not received any periodontal treatment within the past six months of baseline examination. 5. dentition with at least 20 functional teeth. exclusion criteria: 1. medically compromised patients (history of diabetes mellitus, liver diseases, cardiovascular disease, kidney diseases, rheumatoid arthritis, bone diseases pulmonary disease, viral and fungal infections). 2. patients with calcification disorders (chronic kidney disease with vascular calcification, hyperparathyroidism, excessive intake of vitamin d, valvular calcific aortic stenosis 3. aggressive periodontitis. 4. bleeding disorders 5. gross oral pathology and suppuration 6. patients who had received antibiotic therapy and anti inflammatory within the last six months. 7. anomalies of the immune system. 8. pregnancy and lactation.
effectiveness of tele-exercise training on cardiorespiratory fitness in patients with cardiometabolic multimorbidity

Conditions: Heart Diseases; Type 2 Diabetes; Metabolic Syndrome; Coronary Artery Disease; Heart Failure

Summary: this trial aimed to assess whether assumed increase in physical activity after tele-exercise training can improve cardiorespiratory fitness of patients with cardiometabolic multimorbidity.

a parallel-group randomized controlled trial was conducted. eligible patients with cardiometabolic multimorbidity were randomized 1:1 to either experimental group (eg, received a tele-exercise training program) or control group (cg, usual care only). the intervention encompassed tele-exercise training program (30 min/session, 3 sessions/week) and weekly remote monitoring for maintenance of exercise. physical activity and cardiorespiratory fitness were assessed at baseline and 12 weeks. generalized estimating equations were used to examine the intervention effects via the interaction of time and group.

Eligibility criteria:
inclusion criteria: * confirmed diagnoses of cardiometabolic multimorbidity, defined as the presence of two or more cardiometabolic conditions (i.e., hypertension, type 2 diabetes, hyperlipidaemia, heart disease, metabolic syndrome, or gout) * aged 18-80 years * able to speak and understand mandarin * able to walk without assistance * had mobile phones and could easily access the internet exclusion criteria: * not match the diagnosis of cardiometabolic multimorbidity; and a history of arrhythmia, cancer, end-stage renal disease with dialysis, being diagnosed with mental illness, recent stroke within 6 months * not able to speak and understand mandarin * not able to walk independently or inability to participate due to comorbid neurological, musculoskeletal conditions that produce moderate-to-severe physical disability * did not have mobile phones or could not access the internet at home and whenever necessary

Keywords: exercise physical activity cardiorespiratory fitness
pharmacodynamics assessment study after single subcutaneous dose of sar113244 versus placebo in lupus male and female patients

Conditions: Systemic Lupus Erythematosus

Summary: primary objective: assess in systemic lupus erythematosus (sle) patients the effect of sar113244 on b-cell subsets compared to placebo. secondary objectives: assess in male and female lupus patients after sc single dose of sar113244 the tolerability and safety of sar113244. assess in male and female lupus patients: * the pharmacokinetics of sar113244. * the pharmacodynamics of sar113244 for the following disease parameters: * safety of estrogens in lupus erythematosus national assessment systemic lupus erythematosus disease activity index (selena-sledai) score, british isles lupus assessment group (bilag) score (if applicable), bilag-based composite lupus assessment (bicla) (if applicable), systemic lupus erythematosus responder index (if applicable), lupus-quality of life and functional assessment of chronic illness therapy-fatigue, anti-double stranded deoxyribonucleic acid antibody and anti-nuclear antibody levels and plasma complement levels (c3, c4), erythrocyte sedimentation rate and c-reactive protein. * peripheral blood b and t cell subsets.

the total duration of screening to end of study per subject is 16 weeks with post-study observation on day 198 for anti-drug antibody assessment (for patients with positive anti-drug antibody at end of study only).

Eligibility criteria:
inclusion criteria: * male or female patients, between 18 and 75 years of age, inclusive. * clinical diagnosis of sle by american college of rheumatology (acr) criteria. * autoantibody-positive. * on active and stable sle disease. * b cell subsets expressed as percentage of total b cells above normal. exclusion criteria: * pregnant and nursing. * have received treatment with investigational drugs in the 4 months prior to the screening or 5 half-lives of the drug, which ever is longer. * have received intravenous or oral cyclophosphamide within 180 days of day 0. * severe active lupus nephritis or chronic renal insufficiency. * active or chronic, severe neuropsychiatric lupus. * acute, recent (within 4 weeks of screening), chronic or frequently recurring infection(s), except minor infection. * have current drug or alcohol abuse or dependence. * have a historically positive test or test positive at screening for hiv, hepatitis b, or hepatitis c. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
subjective wearing experience of the total30 for astigmatism lens among satisfied biofinity toric lens wearers

Conditions: Astigmatism

Summary: to subjectively evaluate wearing experience in the t30fa lens among subjects who were already satisfied with their biofinity toric lenses.

this study is a single site, prospective, observational study of the subjective performance of t30fa in symptomatic patients. subjects will be assessed at a screening visit, and 2 follow-up visits. clinical evaluations will include measurement of visual acuity, manifest refraction, and patient questionnaires.

Eligibility criteria:
inclusion criteria: subjects are eligible for the study if they meet the following criteria: note: ocular criteria must be met in both eyes. * subjects who are currently wearing and can answer in the affirmative the following question: "i am satisfied with my current biofinity toric monthly replacement lenses" prior to and after habitual lens optimization. * subjects between the ages of 18-45 who wear their biofinity toric lenses at least 5 days per week, at least 10 hours per day. * prescription with a sphere value between +4.00d and -6.00d inclusive, and a cylinder value between -0.75d and -2.25d. * vision correctable to 20/20 (0.0 logmar) or better in each eye at 6m with their manifest refraction. * willing to attend all study visits. exclusion criteria: if any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study. * ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear. * use of systemic or ocular medications for which contact lens wear could be contraindicated as determined the investigator. * monocular (only 1 eye with functional vision) or fit with only 1 lens (and those patients that cannot be successfully fit with the t30fa lens design). * fitted with monovision. * prior ocular surgery. * history of herpetic keratitis, ocular surgery, or irregular cornea. * pregnant or lactating. the principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial. pregnancy has a known effect on the stability of refractions and visual acuity. as such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
prediction of impaired survival in elderly bladder cancer patients opting for radical cystectomy

Conditions: Bladder Cancer

Summary: the investigators proposes a prospective cohort study in patients with high risk bladder cancer who have opted for radical cystectomy. the investigators aim to correlate pre-operative measures of body composition, cognitive and functional status with impaired survival at 6 months after cystectomy. impairment in this context will be a compilation of several specific objective measures including: 1) death from any cause, 2) major complication (clavien score7 ≥ 3), 3) loss of independent living status, 4) performance status, and 5) global well-being. the study team believes that impairment free survival is an important endpoint as it accounts for many aspects of a patient's functional status that might alter a patient's choice to proceed with radical surgery.


Eligibility criteria:
inclusion criteria: * histologic diagnosis of bladder carcinoma (any histology permitted) * planned treatment with radical cystectomy. * age 65 years or older at the time of radical cystectomy * able to give consent * neoadjuvant chemotherapy is permissible * prior malignancy is permissible, without evidence of disease for at least 2 years * concomitant localized prostate cancer, skin cancer, and in situ malignancies are permissible. * willingness to complete surgical follow-up at the university of michigan for at least 6 months after radical cystectomy. exclusion criteria: * evidence of metastatic bladder cancer * life expectancy less than one year * concurrent treatment on another clinical trial. non-intervention supportive care trials or non-treatment trials, e.g. qol, are allowed
an open-label study of dccr tablet in patients with pws

Conditions: Prader-Willi Syndrome

Summary: the primary objective of this study is to monitor the long-term safety of dccr in pws patients.


Eligibility criteria:
inclusion criteria: * successful completion of clinical study c602, visit 15 * provide voluntary, written informed consent (parent(s) / legal guardian(s) of subject); provide voluntary, written assent (subject, as appropriate) * primary caregiver must be able to communicate with investigator and study site personnel as well as read and complete the study-required questionnaires. exclusion criteria: * positive urine pregnancy test (in females of childbearing potential) * females who are pregnant or breastfeeding, and/or plan to become pregnant or to breast-feed during or within 90 days after study participation * any new disease, condition, or circumstance, which may significantly impact subject safety

Keywords: pws prader-willi syndrome
administration of virus specific ctls for the prophylaxis and treatment of ebv/cmv infections after hsct in china

Conditions: Viral Infection

Summary: cytomegalovirus (cmv) and epstein barr virus (ebv) cause significant morbidity and mortality in hematopoietic stem cell transplantation (hsct) patients in china. antiviral drugs given either prophylactically or as early therapy for patients with detectable viral loads appear to be an effective strategy for reducing viral infections. however, long-term treatment with these drugs is associated with significant toxicity, expense and the appearance of drug resistant virus isolates ultimately resulting in treatment failure. cmv and ebv specific t cells infusion to immunocompromised patients following hsct is able to induce a successful anti-viral response. the primary purpose of this study is to determine the safety and efficacy of the infusion of cmv and ebv specific cytotoxic t cells (ctls) for patients with cmv and ebv reactivation or infection.

to generate cmv/ebv specific ctls, g-csf mobilized hemopoietic progenitor cell (g-hpc) products or nonmobilized peripheral blood apheresis collectings were stimulated with cmv/ebv specific peptides covering most hla alleles among chinese populations. once the investigators made sufficient numbers of t cells, they tested their ex vivo properties.then a fraction of ctls were separated for immediate infusion and the others were frozen for further infusion. if the donor was available, the donor derived ctls were started to produce when cmv reactivation was detected by qpcr in recipients peripheral blood. otherwise, autologous ctls were used. for patients at high risk of developing cmv/ebv infections after stem cell transplantation, a small part of g-hpc products was extracted for ctls generation.

Eligibility criteria:
inclusion criteria: * patients with any type of allogeneic hsct * cmv, adenovirus or ebv activation or infection which is defined as below. ebv/cmv reactivation is defined as cmv/ebv dna levels \> 1000 iu/ml for a single test or \> 500 iu/ml for two consecutive tests. ebv/cmv related disease were defined as the demonstration of cmv/ebv biopsy specimen or clinical diagnosis through symptoms, signs or radiography. * written informed consent and/or signed assent line from patient, parent or guardian * positive cmv or ebv serology of the donor * absence of severe renal disease (creatinine \> 3x upper limit normal) * absence of severe hepatic disease (bilirubin \> 3x upper limit normal, ast \> 3x upper limit normal) * life expectancy \> 30 days exclusion criteria: * active acute gvhd grades ii-iv * received donor lymphocytes infusion(dli) within 30 days * received atg or other immunosuppressive monoclonal antibodies within 30 days * uncontrolled acute infections * active and relapse of malignancy * received steroids treatment more than 0.5 mg/kg/day prednisone
recognition and treatment of dysglycemia. ags - acute glucose service

Conditions: Dysglycemia; Arthroplasty Complications

Summary: ags (acute glucose service ) is an inpatient glucose management service consisting of nurse practitioner and physician. team manages not - consulted- based preoperative assessment, perioperative glucose control, patient education and supervision, but also transition of care postoperatively. the goal is to detect and treat dysglycemias , but also provide an active and constantly ongoing education to other hospital teams. ags improves better overall- survival of arthroplastic patients and is an effective way to recognize and treat dysglycemias and to organize constantly ongoing education.

600 elective knee and hip arthroplastic patients are collected. 200 patients before ag- service will be compared to 400 patients after ags. the latter group is divided to two 200 patients groups: 1) with ags 2) with ags extended to first control in 3 months (ag- nurse may be contacted by phone). patients are followed up up to 5 years. controls will be held after 3 months, 1 year and 5 years after operation including b-hba1c, 15 d quality of life assessment and patient interview. there are several aims of the team and study: to detect, diagnose and optimize treatment (including medication) of diabetic/ dysglycemic patients from preoperative assessment 1 week before operation to postoperative care. with blood glucose target 42 - 86 mmol/mol results better overall survival, lesser complications (i.e. infections, cardiovascular or renal complications) and shorter length of hospital stay. other aim is to find undiagnosed diabetics or those at risk of developing diabetes. one aim is to find risk factors, which lead to stress hyperglycemia during perioperative period or diabetes in 5 years.

Eligibility criteria:
inclusion criteria: * patients aged \> 18 years * elective knee and hip arthroplasty patients exclusion criteria: * patients who are incompetent to give informed consent * patients who are incompetent to assess their quality-of-life personally

Keywords: perioperative complications dysglycemia management team nurse practitioner hospital