Kornimate/medical-research-clean huggingface dataset:
induction chemotherapy followed by radiotherapy alone or concurrent chemoradiotherapy in nasopharyngeal carcinoma

Conditions: Locally Advanced Nasopharyngeal Carcinoma

Summary: in this study, the investigators aim to compare the progression-free survival (pfs) and side effects of radiotherapy (rt) and concurrent chemoradiotherapy (ccrt) in locoregionally advanced nasopharyngeal carcinoma (npc) patients with a satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (nact).

in this study, the investigators aim to compare the survival outcomes and side effects of radiotherapy (rt) and concurrent chemoradiotherapy (ccrt) in locoregionally advanced nasopharyngeal carcinoma (npc) patients with a satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (nact) with docetaxel and cisplatin treated using intensity-modulated radiotherapy (imrt) or tomotherapy (tomo).

Eligibility criteria:
inclusion criteria: 1. patients with newly histologically confirmed non-keratinizing carcinoma. 2. tumor staged as n2-3 or t3-4 (according to the 7th ajcc staging system) 3. no evidence of distant metastasis (m0) 4. performance status: kps\>70 5. with normal liver function test (alt, ast \<1.5uln) 6. renal: creatinine clearance \>60ml/min 7. without hematopathy,marrow: wbc \>4\*109/l, hgb\>80g/l, and plt\>100\*109/l. 8. with controlled blood glucose for diabetes patients 9. written informed consent 10. satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (nact) exclusion criteria: 1. who type i squamous cell carcinoma or adenocarcinoma 2. age \>65 or \<18 3. with a history of renal disease 4. prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin) 5. previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended rt treatment volume) 6. patient is pregnant or lactating 7. peripheral neuropathy 8. emotional disturbance

Keywords: nasopharyngeal carcinoma induction chemotherapy radiotherapy chemoradiotherapy
evaluation of cryotherapy in granuloma pyogenicum

Conditions: Granuloma, Pyogenic; Cryotherapy Effect

Summary: surgical excision needs general anesthesia and might have complications due to anesthesia. cryotherapy can be used in an outpatient setting and doesn't need general anesthesia. this study will evaluate if cryotherapy works in granuloma pyogenicum with the advancement of no general anesthesia.


Eligibility criteria:
inclusion criteria: diagnosis of granuloma pyogenicum exclusion criteria: no approvement of cryotherapy
oral omadacycline vs. oral linezolid for the treatment of absssi

Conditions: Bacterial Infections; Skin Structures and Soft Tissue Infections

Summary: the purpose of this study is to evaluate the safety and efficacy of omadacycline as compared to linezolid in the treatment of adults with acute bacterial skin and skin structure infections.


Eligibility criteria:
inclusion criteria: * patients, ages 18 years or older who have signed the informed consent * has a qualifying skin and skin structure infection * female patients must not be pregnant at the time of enrollment * must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug exclusion criteria: * infections where the outcome is strongly influenced by factors other than protocol-defined treatments and procedures, or that require antibacterial treatment for greater than 14 days * evidence of significant immunological disease * severe renal disease or requirement for dialysis * evidence of septic shock * has a history of hypersensitivity or allergic reaction to any tetracycline or to linezolid * has received an investigational drug within the past 30 days * women who are pregnant or nursing
tubectomy with delayed oophorectomy in high risk women to assess the safety of prevention

Conditions: BRCA1 Gene Mutation; BRCA2 Gene Mutation; RAD51C Gene Mutation; RAD51D Gene Mutation; BRIP1 Gene Mutation; Ovarian Cancer

Summary: the aim of the project is to evaluate the risk-reducing salpingectomy with delayed oophorectomy as an alternative for risk-reducing salpingo-oophorectomy in high risk women with respect to ovarian cancer incidence.

in brca1/2 gene mutation carriers, a risk-reducing salpingo-oophorectomy (rrso) is recommended around the age of 40. this recommendation is based on a 10-40% life-time risk of ovarian cancer in this population and disappointing results of ovarian cancer surveillance for early detection. moreover, the mortality rate of ovarian cancer is high. effects of rrso are a decrease in ovarian cancer risk (80-96%) on one hand and immediate onset of menopause and non-cancer related morbidity on the other hand. the fifty percent breast cancer risk reduction after rrso has become disputable in the last years. based on multiple studies showing that most high-grade serous ovarian cancers develop at the distal end of the fallopian tube, an innovative strategy for rrso has been developed for this study proposal: risk-reducing salpingectomy (rrs) with delayed risk-reducing oophorectomy (rro). however, the safety of this strategy has not been proven yet. before implementing this innovative strategy as standard care we need to investigate the long term effects on ovarian cancer incidence.

Eligibility criteria:
inclusion criteria: * women with a class 5 (definitely pathogenic) brca1, brca2, rad51c, rad51d or brip1 germline mutation in one of the participating centers. * age at inclusion; * brca1: 25-40 years * brca2: 25-45 years * rad51c, rad51d, brip1: 25-50 years * childbearing completed * presence of at least one fallopian tube * participants may have a personal history of non-ovarian malignancy * informed consent must be obtained and documented according to national and local regulatory requirements and the local rules followed in the institution. exclusion criteria: * postmenopausal status (natural menopause or due to treatment) * wish for second stage rro within two years after rrs * legally incapable * prior bilateral salpingectomy * a personal history of ovarian, fallopian tube or peritoneal cancer * current diagnosis or treatment for malignant disease
rapid salivary test to detect sars-cov-2 (covid-19)

Conditions: COVID-19; SARS-CoV 2; Corona Virus Infection

Summary: the present diagnostic accuracy study aims at experimentally validating the use of a rapid salivary test to detect sars-cov-2 infection in both symptomatic and asymptomatic individuals as a preliminary approach to a mass screening program. the study is based on a consecutive recruitment of both patients showing symptoms probably associated with covid-19 (i.e., cough, dyspnea, fever) and asymptomatic patients with a low risk phenotype. the expected number of recruited individuals is 100. the experimental test is a prototype of salivary test based on the lateral flow immunoassay technique and is able to detect the presence of sars-cov-2 in saliva, especially the spike protein (s). the comparison is represented by the nasopharyngeal swab, the gold standard of covid-19 diagnosis. patients will undergo both salivary immunoassay and nasopharyngeal swab, thus the outcome assessors are blinded, since the results of the rrt-pcr analysis require at least 6 hours before being available. the main outcomes are sensibility and specificity of the rapid salivary test, when compared with the gold standard (nasopharyngeal swab).


Eligibility criteria:
inclusion criteria: people who undergo nasopharyngeal swab to confirm or exclude sars-cov-2 infection exclusion criteria: none

Keywords: sars-cov-2 covid-19 saliva ncov-2019 coronavirus
intra-articular injection of allogenic lyophilized growth factors in primary knee osteoarthritis

Conditions: Osteo Arthritis Knee

Summary: the study was conducted on 31-patients with symptomatic primary knee osteoarthritis. the patients were randomized into intervention and control groups. the control group was kept on their medications without intervention. the intervention group received two doses of allogenic lyophilized growth factors (l-gfs); at baseline and after 2 months.

the study included 31 patients with symptomatic primary knee osteoarthritis (koa) the study group was randomized into an intervention group and a control one. the control group patients were kept on their traditional medications without any intervention, while intervention group patients were instructed to stop using non-steroidal anti-inflammatory drugs (nsaid) at least 1 week before the assessment and throughout the study. all participants were subjected to baseline clinical, radiographic, and ultrasonography assessment. follow up assessments was conducted after 6 months. patients of the intervention group received two doses of intra-articular knee injections of allogenic lyophilized growth factors (l-gfs); one dose at the baseline and the other was after 2 months. lyophilized gfs were prepared at the cairo medical centre blood bank from allogenic platelet rich plasma to according a previously published patented method. prior to usage, reconstitution of the product was done using 1-ml saline and 1-ml lignocaine followed by gentle vial rubbing for 3 minutes. then, the mixture was kept at ambient temperature for 5 minutes to ensure complete protein re-hydration. the injection was done under complete guidance of ultrasonography through lateral supra-patellar short axis in-plane approach under sterile aseptic conditions. after injection, local ice application and oral paracetamol were allowed if the patient felt pain. nsaids were completely avoided as they may inhibit the desired post-injection inflammatory process. patients were encouraged to restrict vigorous knee activities for 48 hours.

Eligibility criteria:
inclusion criteria * clinical and radiographic diagnosis of primary knee osteoarthritis * patients must be symptomatic exclusion criteria: * patients with secondary knee osteoarthritis * previous intra-articular steroid, or hyaluronic knee injection in last year * patients with other disabling lower limb osteoarthropathy or myopathy

Keywords: osteoarthritis allogenic platelet rich plasma lyophilization growth factors
glp analogs for diabetes in wolfram syndrome patients

Conditions: Diabetes Mellitus Associated With Genetic Syndrome; Wolfram Syndrome

Summary: wolfram syndrome, also referred to as didmoad (diabetes insipidus, diabetes mellitus, optic atrophy and deafness) is a genetic syndrome characterized by beta-cell dysfunction and apoptosis leading to diabetes, neurodegeneration and psychiatric illness. accumulating evidence indicates that beta-cell failure and neuronal cell dysfunction in wolfram's syndrome results from a high level of er stress in affected cells. the current treatment of wolfram syndrome is insulin, which fails to prevent the progression of beta-cell failure. several studies showed that glp-1 analogs are very effective in protecting beta-cells from er stress. herein, the investigators suggest studying the impact of glp-1 analogs in the treatment of patients with wolfram syndrome. the investigators will study the effects of glp-1 analog (exanatide) on beta-cell function and glycemic control of patients with wolfram syndrome. evaluation of beta cell function will be done by performing meal test and ivgtt test before starting glp-1 therapy, and after 3 month of treatment.


Eligibility criteria:
inclusion criteria: 1. genetic or definitive clinical diagnosis of wolfram's syndrome including: diabetes mellitus, optic atrophy and at least one additional neurological dysfunction (diabetes insipidus, sensorineural deafness, neurogenic bladder or other type of autonomic or peripheral neuropathy) 2. age \>18 years 3. duration of diabetes of \<10 years. exclusion criteria: 1. pregnant women 2. patients who are unable to give inform consent.

Keywords: wolfram syndrome diabetes mellitus exenatide glp-1 analog beta cell function
ub-421 in combination with optimized background regimen in patients with multi-drug resistant hiv-1 infection

Conditions: HIV-1 Infection

Summary: the purpose of this phase iii study is to evaluate the efficacy between treatments (ub-421 arm vs. placebo arm) by measuring the proportion of subjects with reduction in hiv-1 rna viral load.


Eligibility criteria:
inclusion criteria: 1. hiv-1 seropositive 2. have a history of at least 6 months on antiretroviral treatment 3. receiving a stable combination antiretroviral therapy (art) for at least 8 weeks before screening exclusion criteria: 1. subjects with hbsag positive or hcv antibody positive, along with alt or ast \> 4 x upper limit of normal (uln) 2. females who are pregnant 3. any vaccination within 2 weeks prior to the screening 4. any prior exposure to ub-421
depression care for hospitalized coronary heart disease patients: prospective cohort study

Conditions: Coronary Heart Disease; Depression

Summary: the aims of this prospective, observational study are to assess the current use of depression care in coronary heart disease (chd) patients, and to provide estimates for the resources needed to implement guideline-oriented depression health care acceptable to chd patients with comorbid depression.

in patients with established chd, unipolar depression is up to three times more prevalent than in the general population and increases the risk for coronary events and mortality, higher health care consumption and decreased quality of life. most hospitals in germany have a unique infrastructure of psychiatric, psychosomatic and psychosocial services for chd patients (psychiatric/psychosomatic consultation liaison services and a wide network of inpatient or outpatient cardiac rehabilitation centers). however, as of today, little is known about the current use and acceptability of depression health care from the perspective of chd patients. this project has two main aims: 1. to assess the current use of depression care in chd patients who are hospitalized or receive ambulatory care at a cardiology clinic 2. to provide estimates for the resources needed to implement guideline-oriented depression health care acceptable to chd patients with comorbid depression. specifically, the investigators will assess * rates of and satisfaction with depression health care use in hospitalized chd patients within one year after hospitalization * perceived need for depression care and patient preferences for different types, settings and providers of these services * correlates of depression health care use and patient preferences * the amount of patients in need for depression health care according to existing recommendations the secondary objective is to assess direct and indirect costs associated with depressive symptoms and depression care use across 1 year (as indicated by quality of life, event-free survival, productivity, and health care costs).

Eligibility criteria:
inclusion criteria: * chronic chd (confirmed by a clinician) exclusion criteria: * chart-documented dementia disorder * cognitive impairment * life expectancy \< 1 year * unavailability for follow-up * insufficient proficiency in german or turkish language

Keywords: coronary heart disease depression health care services
study of cisplatin-induced peripheral neuropathy in patients with germ cell tumor

Conditions: Testicular Germ Cell Tumor

Summary: this is a prospective observational study investigating the incidence, characteristics of, and change in chronic neuropathy symptoms related to cisplatin using the eortc cipn-20 instrument. approximately 60 patients will be collected for this study. the duration of this study will be up to 18 months for each patient. this study will complement a current r01 funded trial (platinum study) which evaluates the genetic predisposition of chronic neuropathy after 12 months of chemotherapy. however, although the platinum study evaluates a similar patient population, it does not evaluate the natural history of platinum induced neuropathy during active treatment and the first 12 months post chemotherapy. this trial will fill this gap and add to the investigators knowledge for both natural history and genetic predisposition of platinum neurotoxicity.

primary objective: to describe the incidence and characteristics of, and change in, chronic neuropathy symptoms related to cisplatin, using the eortc cipn-20 instrument procedures: the eortc qlq-cipn20 questionnaire will be completed on day one of each cycle of chemotherapy, once every three weeks (+/-7 days) and once every 2 months (+/- 30 days) from the last dose of chemotherapy. patients will be asked to complete the questionnaire in clinic during their routine visits. as part of this study, a dna blood sample will be collected and stored with the indiana biobank on day 1 of cycle 1.

Eligibility criteria:
inclusion criteria: 1. 15 years of age or older at the time of informed consent 2. have a confirmed pathologic and/or by tumor marker diagnosis of testicular or extragonadal germ cell cancer. 3. provide written informed consent and assent (if applicable). 4. ability to complete questionnaire(s) in english by themselves or with assistance. 5. willing to provide a 10 ml blood sample for future dna testing 6. planning to receive at least 3 cycles of cisplatin (20 mg/m2/d for 5 days) based chemotherapy. 7. must agree to continued clinical follow-up at the study cancer center. exclusion criteria: 1. diagnosis (current or previous) of peripheral neuropathy (from diabetes or other causes). 2. previous exposure to neurotoxic chemotherapy drugs including taxanes, platinum agents, vinca alkaloids, or epothilones. 3. salvage chemotherapy treatment or bone marrow transplant. salvage chemotherapy is defined as any treatment after relapse of the disease following initial chemotherapy treatment.

Keywords: cisplatin-based chemotherapy chemotherapy-induced peripheral neuropathy
post-operative rehabilitation of total knee arthroplasty with applications on smart phone

Conditions: Osteoarthritis, Knee; Arthropathy of Knee

Summary: this study is designed to estimate the effect of an application on rehabilitation for osteoarthritis patients after total knee arthroplasty.

apart from surgical technique, the outcome of total knee arthroplasty (tka) also largely depend on adequate rehabilitation and subsequent functional recovery after surgery.rehabilitation affects or even determines various performance of post-operative knee, including knee range-of-motion (rom), muscle strength, functional independence, all of which subsequently affect patients' quality of life. conventional way of rehabilitation is exercise therapy, which rely on guidance of therapists and the self-efficacy of patients. an application (app) on smart phone was designed for people received tka to play the role of guider and help improving patients' self-efficacy. this is a single-centre randomized clinical trial, with an anticipation of 200 patients with knee osteoarthritis enrolled, who will be randomly assigned into experiment group or control group. the patients in the experiment group will be introduced to this app and requested to use it regularly, while the patients in the control group will receive pure conventional rehabilitation. primary outcome includes visual analogue scale (vas) of pain, knee society score (kss), rom, ability of daily living (adl) before operation and at 2 weeks and 6 weeks after surgery. all potential covariates of those two groups, such as age, sex, and pre-operative kellgren-lawrence scores would be matched by completely randomize.

Eligibility criteria:
inclusion criteria: * diagnosed as knee osteoarthritis with bearing x-ray * education level of middle school and above * prepared to take single-knee primary tka exclusion criteria: * severe varus/valgus (over 10 degree) of affected knee before surgery * stiffness of affected knee before surgery

Keywords: rehabilitation application on smart phones
efficacy of fixed monthly dosing of ranibizumab in neovascular age-related macular degeneration

Conditions: Wet Macular Degeneration

Summary: the objective of this pilot study is to evaluate the efficacy of intensive fixed monthly dosing of intravitreal lucentis® (ranibizumab) for the treatment of srf and ped in neovascular amd which is persistent to anti-vegf (anti-vascular endothelial growth factor) monotherapy.

peds occur in up to 62% of eyes with advanced amd. numerous treatment options have been employed for peds in amd, including laser therapies and intravitreal injections of anti-vegf antibodies. however, eyes with peds were excluded from the larger clinical trials that used macular laser, photodynamic therapy, or ranibizumab to treat neovascular amd; therefore, the efficacy of such options is still unclear for eyes with peds in neovascular amd. additionally, ped lesions have been reported to show less morphological and functional response to anti-vegf monotherapy than eyes with other cnv lesions subtypes. based on the generally poor prognosis of peds and the lack of sufficient data in the literature regarding the effectiveness of fixed monthly dosing of lucentis® (ranibizumab) therapy, the investigators designed a prospective study to evaluate the effect of intensive fixed monthly dosing of ranibizumab for the treatment of srf associated with ped in neovascular amd which is persistent to previous anti-vegf monotherapy.

Eligibility criteria:
key inclusion criteria 1. ability to provide written informed consent and comply with study assessments for the full duration of the study. 2. age equal to or older than 50 years. 3. presence of srf associated with ped in neovascular amd (proven with oct fa, and icg) which is persistent despite consecutive anti-vegf injections for at least 9 months (3 initial loading doses with 4 week interval followed by prn regimen) * a "persistent ped" is defined as a subject with \< 50% reduction or increase in ped height key exclusion criteria 1. administration of periocular, intravitreal, or systemic corticosteroid within 3 months prior to visit 1 in the study eye 2. prior treatment with photodynamic therapy in the study eye 3. previous subfoveal focal laser photocoagulation involving the foveal center in the study eye 4. previous submacular surgery in the study eye 5. history of vitrectomy in the study eye 6. epiretinal membranes (erm) 7. submacular hemorrhage or fibrosis within 50% of entire ped.