Kornimate/medical-research-clean huggingface dataset:
evaluation of the diagnostic and prognostic efficacy of mri in acute sensorineural hearing loss and ménière's disease

Conditions: Sudden Sensorineural Hearing Loss; Meniere Disease; Ménière's Vertigo; Meniere's Disease Aggravated; Inner Ear Disease

Summary: evaluation of the diagnostic and prognostic efficacy of nuclear magnetic resonance imaging in patients with acute sensorineural hearing loss or in patients suffering from probable or definite md. the neuroradiological and audiological evaluation are held on in the same day in order to better clarify the radiological and clinical correlates.

aims of the study: 1. evaluate the diagnostic accuracy of mri with the collection of more specific sequences for the inner ear (3d-flair) in identifying intralabyrinthine anomalies in patients with ménière's disease or acute/subacute sudden hearing loss and not only the retrochlear pathology/neurological causes . 2. characterize the vascular and inflammatory mri patterns 3. define the prognostic role of mri with pre- and post-contrast 3d-flair sequence, eliminating confounding factors such as mri execution time, the methodology used, the effect of previous therapy and the criteria for defining improvement. 4. correlate 4-hour 3d-flair mri imaging data with clinical and hematological data

Eligibility criteria:
inclusion criteria: age \> 18 years * onset of symptoms less than 10 days * no previous episodes of sudden ipsilateral hearing loss * no systemic or oral corticosteroid intake in the previous month * informed consent exclusion criteria: * current or previous otopathy and/or labyrinth diseases of known cause * known nervous system disorders * patients with renal insufficiency (creatinine level \> 1.5 mg/dl) * patients with pacemakers, other metal implants, claustrophobics and known psychiatric disorders * pregnant patients materials and methods diagnostic evaluation at enrollment (t0) * audiological or ent examination * liminal tonal audiometric exam, vocal, impedance measurement, otoacoustic emissions, video-impulse test, ovemps, cvemps, stabilometry * hematological tests: complete blood count, esr, pcr, creatininemia, cmv igm, ebv igm, ana, glycemia, study of predisposing genetic factors
a study of cemiplimab plus chemotherapy versus cemiplimab plus chemotherapy plus other cancer treatments for adult patients with operable non-small cell lung cancer (nsclc)

Conditions: Non-Small Cell Lung Cancer

Summary: this study will enroll adult participants with early-stage (stage ii-iiib) non-small cell lung cancer for whom surgery is planned. the aim is to find out whether an investigational treatment (consisting of the immunotherapy drug cemiplimab plus chemotherapy plus a third drug) works better than cemiplimab plus chemotherapy without the additional drug. the study is also looking at several other research questions, including: * what are the side effects associated with the investigational treatments in comparison to the control treatment? * do the investigational treatments or the control treatment have an effect on the type of surgery that is performed? * how much of the study drug(s) are in the blood at a given time? * does the body make antibodies against the study drugs (which could make the drugs less effective or could lead to side effects)?


Eligibility criteria:
general key inclusion criteria: 1. histologically confirmed stage ii through iiib (n2) nsclc, that is considered resectable with curative intent, as described in the protocol 2. measurable disease per response evaluation criteria in solid tumors (recist) criteria version 1.1 3. available formalin-fixed paraffin-embedded (ffpe) tumor sample blocks for submission, as described in the protocol 4. eastern cooperative oncology group performance status scale (ecog ps) of 0 to 1 5. adequate organ and bone marrow function, as described in the protocol general key exclusion criteria: 1. any systemic anti-cancer therapy or radiotherapy for the current tumor, as described in the protocol 2. presence of known oncogenic alterations in epidermal growth factor receptor (egfr) or anaplastic lymphoma kinase (alk) in the tumor prior to randomization, as described in the protocol 3. presence of ≥ grade 2 peripheral neuropathy 4. another malignancy that is progressing or requires active treatment, as described in the protocol arm specific exclusion criteria: arm 1: 1. grade ≥3 hypercalcemia, as defined in the protocol 2. any central nervous system (cns) pathology that could increase the risk of immune effector cell-associated neurotoxicity syndrome (icans), as described in the protocol 3. has marked baseline prolongation of the time from the start of the q wave to the end of the t wave in electrocardiogram(qt)/corrected qt interval (qtc) interval or risk factors for prolonged qtc, as described in the protocol note: other protocol-defined inclusion/exclusion criteria apply.

Keywords: lung carcinoma resectable nsclc
novartis pandemic influenza a (h1n1) vaccine(s) observational comparative safety study

Conditions: Influenza

Summary: the primary objective of this observational, comparative safety study is to evaluate the safety of the novartis pandemic influenza a (h1n1) vaccine in pregnant women and their off spring, followed for up to 3 months of age as compared to pregnant women who have not received the novartis pandemic influenza a (h1n1) vaccine. this study will be conducted at investigative sites within the netherlands, italy, and argentina.


Eligibility criteria:
inclusion criteria: * currently pregnant or was pregnant following the introduction of the novartis pandemic influenza a (h1n1) vaccine in the country of interest and have already experienced a pregnancy outcome * consents to participate in the study exclusion criteria: * is not currently pregnant or was not pregnant at the time of or after the introduction of the novartis pandemic influenza a (h1n1) vaccine in the country of interest * does not consent to participate in the study * has received a non-novartis pandemic influenza vaccinee
tea-beetroot-venous occlusion plethysmography

Conditions: Insulin Resistance; Obesity

Summary: in the present study, muscle perfusion will be studied before and after an oral glucose challenge following a fasting period.

based on data from previous studies, this physiological response is blunted in obese subjects, and the investigators expect these responses to be restored when the glucose load is combined with tea or beetroot juice in obese, insulin resistant men.

Eligibility criteria:
inclusion criteria: * male sex * aged 30-70 years. * obesity (bmi\>30 kg/m2) * insulin resistance as fasting glucose levels \>6.1 mmol/l. * reported intense sport activities \>10 h/w. * reported alcohol consumption \>28 units/w * signed informed consent * currently not smoking and being a non-smoker for at least 3 months prior to the start of the study. exclusion criteria: * bmi ≥ 40 kg/m2. * presence of cardiovascular disease. * presence of sudden cardiac death in a 1st degree relative at an age \<50 years. * presence of diabetes mellitus type 2. * regular tea drinker (\> 2 cups per day)

Keywords: obesity, insulin resistance, muscle perfusion
microbiome and endometrial receptivity in obese infertile women

Conditions: Endometrial Receptivity

Summary: the objective of this project is the identification and quantification of the main bacterial communities present in the endometrial microbiota in obese infertile patients, to assess if there is an alteration of their composition dependent on the body mass index, and if such alteration it could influence the reduction of endometrial receptivity, demonstrated in obese women. if obese patients have an altered digestive microbiota and, at the same time, a lower endometrial receptivity, the investigator want to assess whether such reduction in receptivity may depend on an alteration in the endometrial microbiota, which in non-obese infertile patients has been shown to negatively influence the reproductive results

the main objective of our study is to compare the composition of the endometrial microbiota between patients with normal weight and patients with obesity. a. secondary objectives/research questions * to analyze the composition of the digestive microbiota through samples of saliva and feces in infertile patients with normal weight and obesity. * to assess whether there is a relationship between the body mass index (normal weight, obesity class i, class ii, class iii) and the main bacterial species detected in endometrial fluid samples from infertile patients. * to evaluate the influence of the digestive microbiota on the composition of the endometrial microbiota according to the body mass index in infertile patients. * to evaluate if there is an influence of the endometrial microbiota on the results of endometrial receptivity analyzed with the non-invasive endometrial receptivity array test (niera)

Eligibility criteria:
inclusion criteria: * infertile patients undergoing artificial cycle with hrt. * normal uterus confirmed by ultrasound (absence of uterine pathology such as submucosal or intramural myomas\> 4 cm that deform cavity, endometrial polyps or müllerian anomalies, or adnexal as communicating hydrosalpinx). * negative serological tests for hiv, hbv, hcv, rpr exclusion criteria: * taking prescribed antibiotics or using iuds or contraceptives 3 months prior to taking the sample. note: patients who have taken prophylactic antibiotics for ovarian puncture may be included at least 1 month before taking the sample. * age\> 45 years * uncorrected uterine pathology, uncorrected hydrosalpinx * recurrent miscarriage (≥2 spontaneous abortions) or failure of implantation (transfer of 6 embryos in day 3 or 4 blastocysts in a cycle of ivf or donation of oocytes without gestation) * existence of serious or uncontrolled bacterial, fungal or viral infections that, in the opinion of the principal investigator, could interfere with the participation of the patient in the study or in the evaluation of the results of the study. * any disease or medical condition that is unstable or could endanger the patient's safety and compliance in the study.

Keywords: endometrial microbiome obesity bacterial pathogens dysbiosis endometrial receptivity
using a video otoscope in pediatric ear examination: a prospective randomized controlled study:

Conditions: Parental Satisfaction of Using Video Otoscopy in Pediatric Emergency Room

Summary: medical care today is moving towards patient centered care (pc) and patient empowerment (pe), both in practice and in medical staff training . applying this methodology enhances patient autonomy in the clinical setting and allows shared decision making. current mobile and video technology enables the caregiver(clinician) to share visual data with the patient, making him or her a more active participant in the medical procedure. it has been shown that higher patient satisfaction rate regarding the patient/physician encounter, has a positive effect on medical procedure outcome and patient compliance. patient centered care and patient empowerment benefits are maximized using the proper tools. one such tool is the video otoscope. in this study we apply the pc/pe approach of medical care and introduce video otoscopy in the setting of a pediatric emergency room. we use an affordable (\~300$), fda approved, high res. video otoscope. (de500 digital video otoscope,firefly global inc.) patients will be randomized upon admission into two groups: video otoscopy and standard otoscopy. upon discharge from the pediatric er, parents will be asked to answer a short questionnaire regarding their satisfaction with the er visit and the otoscopic examination. we aim to study the impact of affordable, high res. video otoscopy, on the general satisfaction of parents from their emergency room experience, vs their experience when undergoing a regular otoscopic examination. inclusion criteria: children under 18y admitted to the pediatric er for any reason, undergoing routine otoscopy, who's parents have signed an informed consent. exclusion criteria: no parental informed consent,lake of compliance or inability to perform otoscopy. number of participants: 60 (30 in each group) study start: january 2015 study ends:january 2016 study location: ziv medical center, zefat israel


Eligibility criteria:
inclusion criteria: * children under 18y admitted to the pediatric er for any reason, undergoing routine otoscopy, who's parents have signed an informed consent. exclusion criteria: * no parental informed consent, lack of compliance or inability to perform otoscopy.
alpha-lipoic acid in diabetic nephropathy

Conditions: Type 1 Diabetes

Summary: endothelial dysfunction in diabetes is a central event in the pathogenesis of different microangioapthic changes. nephropathy in patients with type 1 diabetes is a severe microvascular complication.

better understanding of the pathogenesis of microvascular complications in type 1 diabetes have paved the way for novel therapeutic targets and possible adjuvant therapeutic modalities. oxidative stress is considered a common and important factor that links hyperglycemia with the vascular complications in diabetes, including of diabetic nephropathy (dn). alpha lipoic acid (ala), or thioctacid, is an antioxidant compound which serve as a cofactor for mitochondrial respiratory enzymes. ala can scavenge free radicals, activate antioxidant systems, and also affect inflammatory markers. it also has unique characteristic. ala can play as a reduction for oxidized forms of components with antioxidant properties and neutralize reactive oxygen species. thus, it called as antioxidant of antioxidants

Eligibility criteria:
inclusion criteria: * children and adolescents with type 1 diabetes * the presence of diabetic nephropathy exclusion criteria: * renal impairment due to causes other than diabetes * other diabetic complications than nephropathy * elevated liver enzymes * hypersensitivity to lipoic acid * participation in a previous investigational drug study within the 30 days preceding screening
clinical study of effectiveness of radiotherapy before surgery in high-risk relapse hepatocellular cancer patients

Conditions: Carcinoma, Hepatocellular

Summary: this study aims to evaluate the effectiveness of radiotherapy before surgery in high-risk relapse hepatocellular cancer patients.


Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of hcc 2. in high risk of recurrence of hcc but still can endure palliative resection 3. kps scores are \>90 4. with child-pugh class a liver funcion, serum bilirubin\ 4×109/l, hb\>110g/l, plt\>90x109/l. 5. have signed informed consent exclusion criteria: 1. hcc cannot be operated 2. with child-pugh class b/c 3. have other organ cancer, excluding curative non-melanotic skin cancer and carcinoma in situ of cervix 4. have other severe disease 5. with active hepatitis 6. have accepted local radiation therapy in other hospitals 7. kps scores≤70 8. tumor edges cannot be defined 9. have severe cirrhosis complication 10. intensity modulated radiation therapy cannot reach required dose 11. cannot cooperate 12. lactant or pregnant 13. cannnot be informed

Keywords: radiotherapy general surgery
endocrinological changes due to pre-medications of chemotherapy in patients with breast cancer

Conditions: Breast Cancer

Summary: treatment for patients with high-risk breast cancer diagnoses is based on chemotherapy drugs with side effects. dexamethasone is a drug that is part of the arsenal of pre-chemotherapy medications to prevent adverse events resulting from treatment, however common endocrine pathological conditions resulting from high doses of this corticoid are clinically evident in these individuals. the aim of this study is to evaluate the omission of corticosteroid doses as a pre-medication in cancer treatment after the second week of treatment with taxane in a curative setting.

treatment for patients with diagnoses of high-risk breast cancer is based on chemotherapy drugs such as anthracyclines and taxanes and its main side effects described are cardiac toxicity and hypersensitivity and / or allergic reactions, respectively. dexamethasone is a drug that is part of the arsenal of pre-chemotherapy medications to prevent adverse events resulting from treatment, however common endocrine pathological conditions resulting from high doses of this corticoid are clinically evident in these individuals. these changes certainly have a negative impact on the patient's quality of life, however, with early recognition and the treatment of hypercortisolemia, we can lead to a reduction in morbidity and mortality in cancer patients. the objective of this study is to evaluate whether the omission of corticosteroid doses as pre-medication in cancer treatment after the second week of treatment with taxane in a setting with curative intent can prevent or decrease the incidence of endocrinological changes, and what is its impact on treatment and on quality of life of the patient. this is a prospective, randomized clinical study, without blinding as a research strategy used to increase the validity of clinical trials that evaluate the effect of interventions (eg, drugs or exercise). the process involves randomly assigning participants to an intervention group or to a control group and requires that participants have an equal chance of being allocated to either group. will be recruited 86 patients diagnosed with breast cancer with indication for neoadjuvant or adjuvant treatment with the standard icesp protocol.

Eligibility criteria:
inclusion criteria: * patients from the oncology services of icesp and its osasco unit. * over 18 years of age. * diagnosed with breast cancer who will be treated with an act icesp scheme in the setting with curative intent (neoadjuvant and adjuvant). exclusion criteria: * patients with significant cognitive impairment that prevents the questionnaire from being applied. * patients who are not fluent in portuguese, or illiterate, who did not sign the icf. * ecog 3 and kps \<70%. * metastatic patients, with the presence of other important morbidities that may interfere with laboratory findings. * patients with chronic use of steroidal and non-steroidal anti-inflammatory drugs.

Keywords: breast cancer endocrinological changes dexamethasone
a study of guselkumab in participants with systemic sclerosis

Conditions: Scleroderma, Systemic

Summary: the purpose of the study is to evaluate the efficacy of guselkumab in participants with systemic sclerosis (ssc).


Eligibility criteria:
inclusion criteria: * diagnosis of systemic sclerosis (ssc) according to american college of rheumatology (acr) and european league against rheumatism (eular) 2013 criteria * diffuse cutaneous ssc according to the leroy criteria that is, skin fibrosis proximal to the elbows and knees in addition to acral fibrosis * disease duration of ≤36 months (defined as time from first non-raynaud phenomenon manifestation). * greater than or equal to (\>=) 10 and less than or equal to (\<=) 22 modified rodnan skin score (mrss) units at screening and week 0 * forced vital capacity (fvc) \>= 60 percent (%) of predicted at screening * diffusing capacity of the lung for carbon monoxide (dlco) \>= 40% of predicted (hemoglobin-corrected) at screening. * participants who meet 1 of the following criteria at screening: increase of \>=3 mrss units, compared with an assessment performed within the previous 2 to 6 months; involvement of 1 new body area with an increase of \>=2 mrss units compared with an assessment performed within the previous 2 to 6 months; and involvement of 2 new body areas with increase of \>=1 mrss units compared with the assessment within the previous 2 to 6 months exclusion criteria: * history of liver or renal insufficiency (estimated creatinine clearance below 60 milliliter per minute \[ml/min\]); significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances * has any known severe or uncontrolled ssc complications including hemoptysis, pulmonary hemorrhage, renal crisis * has an interstitial lung disease requiring oxygen therapy * has any rheumatic disease other than ssc such as rheumatoid arthritis (ra), polymyalgia rheumatica (pmr), systemic lupus erythematosus, polymyositis/dermatomyositis that could interfere with assessment of ssc * has a current diagnosis or signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances. (or, in the investigator's opinion, any other concomitant medical condition that places the participant at risk by participating in this study)
locking compression plate fixation versus revision- prosthesis of vancouver-b2, b3 and c periprosthetic femoral fractures after total hip replacement

Conditions: Periprosthetic Fractures

Summary: the purpose of this study was to compare the clinical (range of motion, weight bearing, quality of life) and radiographic outcome (boney consolidation) between open reduction and internal fixation using locking compression plates with revision prosthesis using a non-cemented long femoral stem in a group of patients with a vancouver type-b2, b3 and c periprosthetic fracture after primary total hip replacement.


Eligibility criteria:
inclusion criteria: * patients with vancouver type- bli, biii and c fractures and unstable femoral prosthesis stem. exclusion criteria: * patients with pathological fractures, * vancouver type-a, bl, and * stable femoral prosthesis stem, * patients with hemi - prosthesis and periprosthetic femoral fractures were excluded from final analysis.
"hepafast" in non-alcoholic fatty liver disease (nafld)

Conditions: Non-alcoholic Fatty Liver Disease (NAFLD); Obesity

Summary: the purpose of this study is to investigate whether a weight reduction with "hepafast" in combination with raw food and vegetables for two weeks followed by a meal substitution with "hepafast" and a calorie restriction in accordance with the low glycemic and insulinemic diet (logi) for 10 weeks is superior regarding improvement of non-alcoholic fatty liver disease (nafld) compared to a conventional weight reduction in accordance with the logi diet without use of "hepafast" for 12 weeks.


Eligibility criteria:
inclusion criteria: * bmi between 30-40 kg/m2 * suspected or diagnosed non-alcoholic fatty liver disease (nafld) exclusion criteria: * other liver diseases * kidney failure * pregnancy, lactation * diabetes mellitus which is treated with insulin * alcohol abuse * several drugs

Keywords: non-alcoholic fatty liver disease (nafld) obesity hepafast