Kornimate/medical-research-clean huggingface dataset:
feasibility and efficacy of an ipad-based cognitive rehabilitation program in brain tumor patients

Conditions: Glioma

Summary: this pilot clinical trial studies how well an ipad-based cognitive rehabilitation program works in improving quality of life in patients with grade ii-iii glioma. an ipad-based cognitive rehabilitation program may help to increase patients cognitive function and quality of life, and may provide doctors with valuable information for optimizing care of patients with brain tumors.


Eligibility criteria:
inclusion criteria: * patients must have histologically confirmed who grade 2 or 3 gliomas. * patients must be \> 18 years old * patients must have a life expectancy \> 12 weeks. * patients must have a karnofsky performance status of \> 70. * this study was designed to include women and minorities, but was not designed to measure differences between them. males and females will be recruited with no preference to gender. minorities will actively be recruited to participate. no exclusion to this study will be based on race. * patients must speak and be able to read english fluently. * all patients must sign an informed consent indicating that they are aware of the investigational nature of this study. patients must sign an authorization for the release of their protected health information. * patients may not be known to be hiv-positive. hiv testing is not required for study participation. * patients must not have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off of all therapy for that disease for a minimum of 3 years. * patients must be receiving mri scans at ucsf * patients must be clinically stable and off treatment (e.g. radiation or chemotherapy) for ≥ 6 months * patients must be ≥ 6 months from craniotomy * patients must have subjective complaints of cognitive deficits. * patients must have adequate seizure control and be on a stable, or decreasing, dose of anti-epileptics exclusion criteria: * patients who are not able to comply with study and/or follow-up procedures. * patients who do not have home access to the internet. * patients who, based on the physician's opinion, are unable to participate in neurocognitive testing and/or neurocognitive rehab secondary to significant neurologic deficit

Keywords: glioma neurocognitive quality of life
predictive clinical features for response to adjuvant immunotherapy in stage ii,iii and iv resected melanoma

Conditions: Melanoma

Summary: surgical excision is the treatment of choice for stage ii, iii and resectable stage iv melanoma and is curative in most cases. given the recent success of immunotherapy for the treatment of patients with advanced metastatic melanoma, the use of immunotherapy has been evaluated in the adjuvant setting for patients at high risk of recurrence. in this context, nivolumab prolonged recurrence-free survival (rfs) while reducing toxicity compared with ipilimumab in a phase iii clinical trial, and was subsequently fda-approved in december 2017 for adjuvant treatment of locally advanced melanoma with metastatic lymph node involvement after resection of cutaneous lesions. while a fraction of patients benefit from adjuvant pd-1 immunotherapy, approximately 40% of patients are still relapsing despite this adjuvant treatment, without being able to identify them early and with poor understanding of resistance mechanisms. additionally, about 15% of the patients will develop serious adverse effects driven by immunotherapy and often discontinuing or even contraindicating the onset of subsequent treatments, hence affecting global patients care. it is therefore of prime importance to identify clinical features able to predict response and toxicities to adjuvant immunotherapy in melanoma.


Eligibility criteria:
inclusion criteria: * patients diagnosed with stage ii, iii or iv (resected) melanoma * treated by surgery and adjuvant immunotherapy between january 1st of 2019 and january 1st of 2029 * gave informed consent to allow the use of biological samples for research purpose * has read the information sheet regarding this study * with tumor samples available at the biobank center exclusion criteria: * patients under 18 years old * patients placed under the judicial protection * opposed to this study

Keywords: melanoma adjuvant immunotherapy
comparing efficacy of postoperative oral antibiotic use in trans-oral thyroidectomy

Conditions: Surgical Wound Infection; Thyroid Nodule

Summary: transoral endoscopic thyroid surgery is a emerging surgical technique for thyroid surgery. this study to investigate the need for postoperative antibiotics in transoral endoscopic thyroid surgery.

to prevent possible infection from the oral cavity flora, most surgeons prescribe postoperative oral antibiotics more than 3 to 7 days after surgery. currently, there's no clinical evidence that postoperative oral antibiotics is necessary or not in transoral endoscopic thyroid surgery. the investigator will conduct randomization after transoral thyroid surgery with two groups : postoperative oral antibiotics group versus no oral antibiotics group.

Eligibility criteria:
inclusion criteria: * patients who planned to transoral endoscopic thyroidectomy * age between 20 to 70 * voluntarily consenting to the study and study agreement * no local invasion or distant metastasis * normal vocal cord function in laryngoscopic exam * no significant abnormalities in preoperative laboratory tests exclusion criteria: * take aspirin or antiplatelet drugs within 7 days before admission * uncontrolled hypertension, diabetes, chronic renal failure, or coagulation disease * history of cardiovascular disease (angina pectoris, heart failure, myocardial infarction, history of coronary artery disease, stroke, transient ischemic attack) * substance abuse and alcohol abuse * history of esophageal and airway diseases * patient was participated in other clinical trials within 30 days * history of neck irradiation or surgery * history of drug allergies * pregnant or lactating women
respiratory muscle training in hemodialysis patients

Conditions: Renal Failure

Summary: the research protocol is a randomized clinical trial that has the effectiveness of a given respiratory muscle training protocol over the indicative variables: pulmonary function; markers of oxidative stress and inflammation, endothelial markers and quality of life in patients with chronic kidney disease undergoing hemodialysis. according to the investigators, this topic was proposed since it is known that several pulmonary complications occur as a consequence of chronic kidney disease due to uremic myopathy. therefore, the hypothesis is that the application of a respiratory muscle training protocol will contribute positively pulmonary functionality and a decrease in oxidative stress and inflammation in chronic kidney patients, consequently, will bring improvement in the quality of life for these patients. the patients will be divided into two groups: control group - no intervention of the muscular training (cg) and intervention group (gi). the intervention protocol will be composed of respiratory muscle training and lasts for two (2) months, with three (3) visits per week. it will be carried out through threshold pep appliance. the twelve (12) first training sessions will have a total duration of 30 minutes 15 minutes with inspiratory load of 20 cmh2o and 15 minutes with expiratory load of 20 cmh 2 o; and the others (12) twelve sessions will last 40 minutes each, with 20 minutes with an inspiratory load of 20 cmh2o and 20 minutes with expiratory load of 20 cmh2o. the variables evaluated will be: muscular strength respiratory (maximum inspiratory pressure and maximum expiratory pressure - pimáx and pemáx); lung function (slow vital capacity - cvl, forced expiratory volume in the first minute - vef1, vital capacity forced - cvf and maximum voluntary ventilation - vvm); serum levels of oxidative stress markers, endothelial markers and endothelin.


Eligibility criteria:
inclusion criteria: * maintenance hemodialysis for more than 3 months * no copd diagnosis exclusion criteria: * decompensated heart failure * acute coronary disease in the last 3 months * active infection
studies of phenotypic and functional characteristics of circulating neutrophil subpopulations in patients with lung cancer

Conditions: Lung Cancer

Summary: the objective is to study the phenotypic, functional and metabolomic characteristics of neutrophils circulating subpopulations in lung cancer patients, and to compare them to a control group of healthy volunteers. a blood sample will be taken before the first treatment session for the lung cancer patient and a second blood sample will be taken during the first evaluation visit. the investigators hypothesize that there may be different circulating neutrophil subpopulations in patients with metastatic non-small cell lung cancer (nsclc) involved in tumor progression and resistance to immunotherapy.

immune checkpoint inhibitors (ici) have been shown to be effective in metastatic lung cancer. unfortunately, 80% of patients do not respond and show rapid disease progression. identifying predictive biomarkers of response is essential for early adaptation of management. circulating lymphocytes and neutrophils represent a biomarker (nlr), predictive of immunotherapy response, in particular via the measurement of the neutrophils /lymphocyte ratio. some preclinical work suggests a role for circulating neutrophil subpopulations like mdsc (myeloid derived suppressor cells) in ici resistance. certain circulating neutrophil subpopulations are thought to promote tumor progression, angiogenesis and metastasis with immunosuppressive activity. identifying these pro-tumor subpopulations could predict the response to ici and could be a potential therapeutic target. our goal is to characterize the circulating neutrophil subpopulations of lung cancer patients and correlate these characteristics with response and survival phenotypically and functionally.

Eligibility criteria:
inclusion criteria common to lung cancer and copd patients : * age ≥ 18 years, * male or female, * affiliated with a health insurance, inclusion criteria for lung cancer patients : - diagnosis of metastatic stage lung cancer with mutation status, naïve treatment inclusion criteria for copd patients : - diagnosis of copd post-smoking exclusion criteria: * tuberculosis or other acute or chronic bacterial infections * chronic progressive viral infections (hepatitis b and c, hiv) * previous or ongoing chemotherapy * impossibility of giving the subject informed information. * opposition to the research. * participation in another research study with an exclusion period still in progress at pre-inclusion (possible inclusion in an observational study) * vulnerable individual (pregnant, parturient or breastfeeding woman), persons under guardianship or curatorship, or deprived of liberty by a judicial or administrative decision) * patients benefiting from the ame

Keywords: neutrophils neutrophil subsets advanced lung cancer biomarkers pd-1 immunotherapy chronic inflammation phenotypic modulation spectral cytometry
impact of drug therapy and co-morbidities on the development of renal impairment in hiv-infected patients

Conditions: Human Immunodeficiency Viruses; Kidney Failure; HIV Infections

Summary: tenofovir (tdf)-containing regimens may be associated with decreasing renal function in hiv-infected patients concurrently treated with boosted pi's and/or have co-morbid conditions including diabetes mellitus, hypertension, anemia, hepatitis b, and hepatitis c.

col109413 is a phase iv retrospective database study involving the review of medical records of approximately 850 hiv-infected patients treated at a single center (peabody health clinic, dallas, texas) and followed for up to a 4-year period (2003-2006). patients whose gfr decreased \>25% from baseline (bl) will be identified and their disease and treatment characteristics will be compared to those of patients whose gfr did not change. gfr will be calculated by both the mdrd and the cockcroft-gault methods. the following information will be noted: patient age, weight, gender, race/ethnicity, viral load, cd4 cell count, serum creatinine and other available laboratory data, start of haart therapy (tdf - vs non-tdf-containing), changes in drug treatment, co-morbidities (hypertension, diabetes mellitus, anemia, hepatitis c virus or hepatitis b virus infection), drug treatment for co-morbidities and non-hiv-related illnesses, and adherence by prescription refill. the study endpoints will be: time from treatment initiation-to-event (gfr decrease \>25% from bl) analysis between tdf-containing vs non-tdf-containing antiretroviral therapy; number of patients who convert from national kidney foundation-defined mild to moderate renal impairment or from moderate to severe renal impairment in the tdf vs non-tdf-treated patients; effect of co-morbidities and concomitant medications on time to gfr decrease \>25% from bl.

Eligibility criteria:
inclusion criteria: * hiv positive patients seen between 2003 and 2006 exclusion criteria: * fewer than two laboratory results

Keywords: human immunodeficiency viruses glomerular filtration rate tenofovir treatment experienced
an evidence based protocol for oxytocin administration in vaginal delivery

Conditions: Uterine Atony; Postpartum Hemorrhage

Summary: the purpose of this study will be to evaluate a standardized, evidence-based protocol versus a conventional approach for the dosing of oxytocin in vaginal delivery.

a traditional practice in many us hospitals includes use of 10-40 iu of oxytocin mixed in various volumes of crystalloid administered at an unspecified and uncontrolled rate (quite often off the pump) in order to restore uterine tone and minimize routine blood loss in the third stage of labor. many practitioners question high dose oxytocin regimens, timing and duration of oxytocin administration for postpartum hemorrhage prophylaxis. given the lack of a universally accepted, evidence based protocol, this study aims at comparing the efficacy of a traditional approach of administration of oxytocin with an evidence-based designed algorithm.

Eligibility criteria:
inclusion criteria: * vaginal delivery exclusion criteria: * cesarean delivery * allergy to oxytocin * cardiac arrhythmia

Keywords: uterine atony postpartum hemorrhage vaginal delivery uterotonic oxytocin bolus evidence-based protocol
advancing diabetes management in adolescents using health information technology

Conditions: Type 1 Diabetes

Summary: the study will compare three treatment strategies to look at the best clinical outcomes. the investigator hypothesizes that the combined approach of a health information technology program plus a conflict-management contract will lead to the best outcomes.

this study will compare three strategies for enhancing adherence to diabetes care in our population. the study will look at which strategy results in the best short-term clinical outcomes for the population. also, the study will look at patient satisfaction of contact with his/her health care team, quality of life, and family dynamics. the three arms are: 1. hit (health information technology) aided approach 2. contracted conflict-management strategy 3. combination of the hit-aided approach and the contracted conflict management strategy

Eligibility criteria:
inclusion criteria: * type 1 diabetes diagnosed for at least 6 months * at least one or more parent/guardian who agrees to participate exclusion criteria: * other chronic diseases with the exception of well-controlled asthma or treated thyroid disease

Keywords: type 1 diabetes adolescents heath information technology
expression of protein tyrosine phosphatase 1b (ptp1b) and body composition modification in patients with septic shock

Conditions: Septic Shock

Summary: with a prevalence of more than 15% in icu, septic shock today represents a real public health problem and remains the leading cause of mortality in icu. undernutrition is characterized by an alteration of the body composition and in particular by a loss of muscle mass. in intensive care, there are indirect elements suggesting a link between loss of muscle mass and prognosis. muscle mass results from a balance between the pathway of proteolysis and that of protein synthesis, depending on many factors, not one of the most important are insulin. the protein ptp1b (protein tyrosine phosphatase 1b), by the dephosphorylation of its numerous substrates, constitutes an endogenous regulator of numerous intracellular signaling pathways, including that of insulin. ptp1b could play a role in the protein synthesis abnormalities observed during sepsis leading clinically to impaired body composition including muscle body mass. therefore, we propose to study the association between ptp1b and loss of muscle mass in patients in sepsis in resuscitation. the intestinal barrier plays an essential role in protecting against microbial luminal flora and the phenomenon of bacterial translocation. zonulin is one of the major regulators of tight junctions, important actors in the intestinal barrier function. the increase in plasma zonulin levels, greater than 0.6 ng / mg, is directly correlated with increased intestinal permeability (16). however, elevation of plasma zonulin has never been evaluated in septic resuscitation patients. this is why we propose the evaluation of the association between plasma zonulin and the loss of muscle mass in these resuscitation patients.


Eligibility criteria:
inclusion criteria: * septic shock or severe sepsis * age \> 18 years old * affiliation to a social security system * information and consent. if patient cannot give his consent, an emergency consent will be sign by trusted person * contraception for woman, of childbearing age exclusion criteria: * pregnancy or breastfeeding * prisoners * patient with pacemaker or defibrillator * patient participating to a clinical trial with the same primary outcome
gastrectomy outcomes in elderly patients

Conditions: Gastrectomy; Elderly; Gastric Cancer; Gastric Adenocarcinoma

Summary: in this study, the investigators aimed to identify independent prognostic factors for early postoperative complications and survival in elderly patients (aged ≥65 years) with gastric cancer.

gastric cancer is the 5th most common type of cancer diagnosed worldwide and ranks 3rd in cancer-related deaths. along with surgical resection, perioperative chemotherapy or chemoradiotherapy are the main treatment method. various complications can be seen in the postoperative period, mainly pulmonary complications (13%), cardiac complications (6%), intra-abdominal abscesses (4%), and anastomotic leaks (3%). approximately 5% of the patients die because of postoperative complications. it is known that low body mass index as a patient-specific factor is associated with postoperative complications and poor prognosis. the incidence of gastric cancer remains relatively high and, with increasing life expectancy, the incidence of gastric cancer in elderly patients is increasing. characteristics of elderly patients, such as reduced physiological function, poor nutritional status, and surgical trauma from radical gastrectomy, seem to result in higher postoperative morbidity, a longer length of hospital stays, increased healthcare costs, and higher postoperative mortality. elderly patients may have a worse prognosis compared to younger patients, primarily because of the increased risk of postoperative complications. perioperative nutritional support and preoperative rehabilitation are beneficial for elderly patients with gastric cancer and may reduce surgical complications and mortality. although some studies in the literature state that radical surgery can be performed for those aged 80 and over, some studies have argued that complications increase in elderly patients and that surgery should be limited. aim of the study is to identify prognostic factors for postoperative outcomes in elderly patients who underwent surgery for gastric cancer.

Eligibility criteria:
inclusion criteria: * patients aged 65 and older * operable patients with histologically confirmed gastric cancer * complete follow-up information exclusion criteria: * patients under 65 years of age * gastric resection for non-neoplastic diseases * missing follow-up information

Keywords: gastrectomy elderly gastric cancer prognosis
differential mobility spectrometry (dms) based oral tumor analysis

Conditions: Oral Squamous Cell Carcinoma

Summary: the trial is a single-center, non-randomized feasibility study aiming to evaluate the feasibility of ex-vivo tissue analysis using differential mobility spectrometry (dms) of tissue smoke generated by the use of an electrosurgical instrument. patients recruited in the trial receive standard-of-care oral squamous cell carcinoma tumor excision surgery.

oral squamous cell carcinoma is the sixth common carcinoma and the cause of 1-2% of cancer related deaths in the world. the incidence of oral squamous cell carcinoma was 255 cases in finland and 742 270 cases worldwide in year 2015. the number of cases per year has been increasing. the approximate age of tumor occurrence is usually between 60 - 70 years. the 5-year survival rate of all diagnosed oral squamous cell carcinoma cases in finland during the years between 2014 and 2016 was 67% for women and 61% for men. early diagnostics is relevant, since oral squamous cell carcinoma tumors have a tendency to grow rapidly and metastasize early to regional lymphnodes and later on to lungs, liver and bones. typical locations of the tumor are tongue, gums and sole of mouth. the primary treatment option for oral squamous cell carcinoma is surgical removal of the tumor with 0,5 - 1cm healthy tissue margin. the aim of the operation is to remove the tumor entirely so that the healthy tissue margins are as sparing as possible and that the functional and cosmetic outcomes are as satisfactory as possible. sufficient healthy tissue margin is one of the most important prognostic factors. nevertheless, there is only little evidence based knowledge of sufficient healthy tissue margins. differential mobility spectrometry (dms) based application called automatic tissue analysis (atas) can be utilized to identify tumor cells from healthy tissue. tissue identification is done by analyzing tissue smoke that is generated by the use of an electrosurgical instrument called diathermy. the objective of the trial is to test whether it is possible to identify oral squamous cell carcinoma tissue from normal oral mucosa by using atas. a 4mm punch biopsy of an oral squamous cell carcinoma tumor and a control biopsy of healthy oral mucosa will be collected from 30 - 40 patients undergoing oral tumor excision. the biopsies will be examined in the research laboratory with atas to test tissue recognition.

Eligibility criteria:
inclusion criteria: * biopsy diagnosed oral squamous cell carcinoma. * tumor diameter of 2 cm or larger. * operable patient that is willing to participate in the trial. exclusion criteria: * tumor diameter less than 2 cm. * patient that is unwilling to take part in the trial. * patient that is not able to understand given information concerning the trial or to give concent to take part in the trial.

Keywords: oral squamous cell carcinoma differential mobility spectrometry (dms) automatic tissue analysis (atas)