Kornimate/medical-research-clean huggingface dataset:
spect/ct for the characterization of renal masses

Conditions: Kidney Neoplasm; Renal Mass

Summary: this trial studies how well technetium tc-99m sestamibi single-photon emission computed tomography/computed tomography (spect/ct) works on clinical decision making in patients with kidney tumors. diagnostic procedures, such as technetium tc-99m sestamibi spect/ct may be a less invasive way to check for kidney tumors.

primary objectives: i. to determine the impact of technetium tc-99m sestamibi (mibi) spect/ct on patient management decisions. secondary objectives: i. to evaluate the impact of mibi spect/ct on patient management decisions for tumors 1.5-3.0 cm and 3.1-5.0 cm. ii. to assess the impact of mibi spect/ct on decisional conflict score. iii. to assess the impact of mibi spect/ct on physician management recommendation. iv. to evaluate the sensitivity and specificity of mibi spect/ct for the identification of an oncocytic renal mass (oncocytoma, chromophobe, and hybrid oncocytic tumor) with respect to tumor histology identified by renal mass biopsy or surgical resection. v. to compare the specificity of mibi spect/ct with conventional cross-sectional imaging in predicting an oncocytic renal mass. vi. to assess the correlation between mibi spect/ct outcomes to final treatment decisions. exploratory objectives: i. evaluate the mitochondria content in tumors that had positive mibi spect/ct findings. outline: patients receive technetium tc-99m sestamibi intravenously (iv) then undergo spect/ct. after completion of study, patients are followed up for 6 months.

Eligibility criteria:
inclusion criteria: * performance status eastern cooperative oncology group (ecog) \< 2. * life expectancy (\> 1 year). * new diagnosis of a renal tumor (within past 3 months). * measurable, predominantly (\> 80%) solid renal neoplasm between 1.5-5.0 cm. * lesion concerning for kidney cancer bases on a contrast-enhanced ct or magnetic resonance imaging (mri). * no definitive evidence of metastatic disease. * does not require urgent surgical treatment. * candidate for surgical, ablative, and surveillance approach. * willingness to obtain more information to aid decision-making. * understanding and willingness to provide consent. exclusion criteria: * presence of multiple solid renal tumors. * a prior needle biopsy of the mass resulting in histologic diagnosis. * a prior diagnosis of kidney cancer. * presence of an active, untreated, non-renal malignancy. * history of bleeding diathesis or recent bleeding episode. * prior surgery or radiation therapy to the kidney. * unwillingness to fill out questionnaires.
safety evaluation of panitumumab and sirolimus in advanced non-small cell lung cancer

Conditions: Oncology; Non-Small Cell Lung Cancer

Summary: to determine the dose and schedule of sirolimus when given in combination with panitumumab in adult subjects with stage iiib/iv nsclc


Eligibility criteria:
inclusion criteria: * histologically- or cytologically-confirmed diagnosis of stage iiib or iv non-small cell lung cancer * received only one prior treatment (not including radiation) * measurable disease per response evaluation criteria in solid tumors group (recist) guidelines * life expectancy of ≥ 4 months * eastern cooperative oncology group (ecog) performance status of 0 or 1 * adequate hematologic, renal and hepatic function * serum-fasting cholesterol ≤ 300 mg/dl serum-fasting triglycerides ≤ 2.5 x uln exclusion criteria: * brain metastases requiring treatment * history of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline * systemic chemotherapy, radiotherapy, hormonal therapy or immunotherapy within 30 days before enrollment * prior epidermal growth factor receptor targeting agents with the exception of the small molecule egfr tyrosine kinase inhibitors * prior anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules and biologics of short serum half-life (less than 1 week) within 30 days before enrollment, or prior experimental or approved proteins/antibodies with longer serum half-life within 6 weeks before enrollment * prior therapy with sirolimus, sirolimus analogs * immunosuppressive agents within 28 days before enrollment

Keywords: nsclc, lung cancer panitumumab sirolimus mtor monoclonal antibody
randomized trial of the impact of body scanning and intensive behavioral intervention on behavioral change and health outcomes

Conditions: Coronary Disease; Behavior and Behavior Mechanisms; Hypertension; Hypercholesterolemia

Summary: we evaluated the effectiveness of a combination of a comprehensive health assessment consisting of the combination of a screening full body scan employing graphic patient education and motivational techniques followed by intensive, individualized behavioral training and management program on improved adherence to beneficial lifestyle behaviors, as well as possibly reduced risk of disease.

we initially enrolled 267 volunteer asymptomatic adults consisting of firefighters/police workers (n= 173), active military personnel (n= 57) and community college staff (n= 37). subjects were randomized either to an intervention group or to usual care. the intervention group received the renew™ program (www.therenewprogram.net) of lifestyle intervention as described below. a whole body ct scan was performed using a multidetector ct scan on all participants at baseline with the results discussed by a physician only in the intervention group, and after 2 years of follow-up a repeat scan was performed with a detailed evaluation of the results discussed by a physician with all participants (in part as a motivation to complete thestudy). this study was carried out in accordance with the recommendations of the western institutional review board with written informed consent from all subjects. all subjects gavewritten informed consent in accordance with the declaration of helsinki. the protocol wasapproved by the western institutional review board.

Eligibility criteria:
inclusion criteria: men or women aged 35 and over who provide informed consent to participate including the baseline, interim, and follow-up clinic visits, as well as willingness to participate in the on-line intervention (if selected to be in that group) - exclusion criteria: known cardiovascular disease, cancer, or any life-threatening or debilitating illness, including psychiatric illnesses, or significant difficulty with the english language that would preclude successful participation in the program -
an observational study of tarceva (erlotinib) in routine practice for first line maintenance therapy in patients with non small cell lung cancer

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Summary: this observational study will investigate the tolerability and efficacy of tarceva (erlotinib) in daily clinical practice under routine conditions in patients with locally advanced or metastatic non small cell lung cancer. data will be collected for approximately 12 months.


Eligibility criteria:
inclusion criteria: * adult patients with locally advanced or metastatic non-small cell lung cancer (stage iiib or iv) with stable disease after 4 cycles of standard platinum-based first-line chemotherapy exclusion criteria: * not willing or not able to sign written informed consent form
a study of participants with initially unresectable hepatocellular carcinoma that is treated with atezolizumab and bevacizumab plus transarterial chemoembolization

Conditions: Unresectable Hepatocellular Carcinoma

Summary: this is a multicenter, retrospective, observational cohort study to describe the effectiveness and safety of atezo+bev plus transarterial chemoembolization (tace) among adult patients with unresectable hepatocellular carcinoma (hcc) in real-world clinical practice in china. eligible patients diagnosed with unresectable hcc initiating the atezo+bev and tace between 28 october 2020 and 31 december 2023 will be included in this study.


Eligibility criteria:
inclusion criteria: 1. initiating both atezo+bev and tace between 28 october 2020 and 31 december 2023 regardless of sequencing, number of doses/cycles, and type of tace 2. at least one dose of atezo+bev and one cycle of tace spaced no longer than 4 weeks 3. diagnosed with hcc and considered as unresectable by any of the below criteria: * predicted insufficient future liver remnant volume (flrv) after liver resection, or * predicted unattainable safe negative tumor margin resection, i.e., r0 resection, or * "unresectable" directly documented in the medical records exclusion criteria: 1. no visit record after initiating both atezo+bev and tace 2. treated with other systemic therapy or resection against hcc 3. diagnosed with concomitant cancer except for basal cell carcinoma 4. advanced portal vein tumor thrombosis (pvtt) as defined by: grade vp 4, cheng's classification type iii or iv, or presence of a tumor thrombus in the main trunk of the portal vein, a portal vein branch contralateral to the primarily involved lobe, or superior mesenteric vein 5. china liver cancer (cnlc) stage iiib, or history of extrahepatic metastasis 6. terminal-stage hcc
safety, tolerability, and immunogenicity of a polyvalent pneumococcal conjugate vaccine (v116) in japanese adults (v116-002)

Conditions: Pneumococcal Infection

Summary: the purpose of this study is to compare the safety, tolerability, and immunogenicity of a polyvalent pneumococcal conjugate vaccine (v116) with that of pneumovax™23 in healthy japanese adults.


Eligibility criteria:
inclusion criteria: * is a healthy japanese male or female ≥20 years of age at time of randomization * male participants must agree to be abstinent or use contraception during the intervention period and for ≥30 days after the last dose of study intervention * female participants must not be pregnant or breastfeeding, and is either: * not a woman of childbearing potential (wocbp) or * a wocbp who agrees to remain abstinent or use contraception during the intervention period and for ≥30 days after the last dose of study intervention exclusion criteria: * has a history of invasive pneumococcal disease (ipd) within 3 years of day 1 * has a known hypersensitivity to any vaccine components * has impaired immunological function * has a coagulation disorder * had a recent febrile illness (axillary temperature ≥37.5°c or equivalent) within 72 hours before day 1 * has a known malignancy that is progressing/requiring treatment * has received, or is expected to receive, a pneumococcal vaccine outside the study protocol * has received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed the regimen for ≥30 days prior to day 1 * is receiving immunosuppressive therapy * has received any non-live vaccine from 14 days prior to day 1 other than inactivated influenza vaccine * has received any live vaccine from 30 days prior to day 1 * has received a blood transfusion or blood products * has participated in another clinical trial within 2 months of this study * has clinically relevant drug or alcohol abuse * has any condition that, in the opinion of the investigator, precludes participation in this study
efficacy and safety of eplivanserin 5mg/day in insomnia characterized by sleep maintenance difficulties

Conditions: Primary Insomnia

Summary: primary objective: - to assess the efficacy of eplivanserin 5mg/day in comparison to placebo after 6 weeks of treatment on sleep maintenance of insomniac patients, as measured by polysomnography wake time after sleep onset (psg-waso) and polysomnography number of awakenings (psg-naw). secondary objectives: * to evaluate the effects of eplivanserin 5mg/day as compared to placebo after 6 weeks of treatment on other sleep parameters measured by psg recordings (total sleep time - psg-tst, sleep efficiency - psg-se, latency to persistent sleep - psg-lps) and reported by patients (wake time after sleep onset - pr-waso, number of awakenings - pr-naw, total sleep time - pr-tst, quality of sleep - qos and refreshing quality of sleep - rqos). * to evaluate the effects of eplivanserin 5mg/day on sleep architecture compared to placebo. * to evaluate the effect of eplivanserin 5mg/day on daytime functioning using the sleep impact scale (sis), as compared with placebo after 6 weeks of treatment. * to evaluate patient's impression of treatment effects using the patient's global impression questionnaire. * to evaluate the potential for next-day residual effects (using patient's morning questionnaire and psychometric tests) with eplivanserin 5mg/day as compared to placebo. * to evaluate the potential for rebound insomnia following abrupt discontinuation of eplivanserin 5mg/day in comparison with placebo. * to evaluate the effect of eplivanserin, compared to placebo, on the quality of life of patients with primary insomnia using the sf-36 health survey. * to evaluate the clinical safety and tolerability of eplivanserin 5mg/day compared to placebo.

randomized, double-blind, placebo, controlled study with 2 parallel groups duration of treatment : 6 weeks duration of observation: 9 weeks

Eligibility criteria:
inclusion criteria: * diagnosis of primary insomnia based on dsm-iv-tr (diagnostic and statistical manual of mental disorders, fourth edition - text revisions) criteria exclusion criteria: * inpatients. * mean screening psg-waso for screening night 1+ screening night 2 \< 45 mn, or screening night with psg-waso \< 30 mn. * mean screening psg-tst for screening night 1 + screening night 2 ≥7 hours or ≤3hours. * mean screening psg-lps for screening night 1+ screening night 2 \> 30 mn. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: insomnia sleep maintenance polysomnography
the effectiveness of ischemic compression and iastm in trigger point treatment in patients with rotator cuff tear

Conditions: Rotator Cuff Tears; Shoulder Pain; Myofascial Trigger Point Pain

Summary: the aim of this study is to determine the effects of ischemic compression and iastm techniques on pain, eha, functionality, anxiety and depression in patients with the diagnosis of rm tear and presence of atn. in addition, ischemic compression and edydm methods were aimed to compare and to reveal which application would be more useful.

in this study participants were randomly divided into two groups. while ischemic compression was applied to one group for the determined active trigger points, instrument assisted soft tissue mobilization (iastm) was applied to the other group for active trigger points. in addition to the treatment, both groups were subjected to a joint rehabilitation program.

Eligibility criteria:
inclusion criteria: * being between 40-65 years old * having been diagnosed with partial rm rupture * rm rupture in mri image * at least 3 atns in the shoulder complex * hawkins-kennedy and empty can tests positive symptoms for at least 3 months exclusion criteria: * sensory problems in the back and shoulders, * shoulder instability * osteoarthritis in the shoulder joint area * glenoid or bone fracture * frozen shoulder pathology * massive rm rupture * rheumatological joint problems * shoulder surgery history

Keywords: ischemic compression instrument assisted soft tissue mobilization trigger point
neoadjuvant chemotherapy with cabazitaxel

Conditions: High-Risk Cancer

Summary: this study is aimed at evaluating the efficacy regarding the response rate and metastasis-free survival time of cabazitaxel as a neoadjuvant treatment in patients with high risk prostate cancer.

patients will be treated by 6 cycles of cabazitaxel 25 mg/m2 every three weeks and extended radical prostatectomy and extended pelvic lymphadenectomy 4 weeks after completion of chemotherapy. multiparametric mri will be performed at baseline, after 3 cycles and after 6 cycles. if there will be evidence of clinical progression after 3rd cycle, patients can be removed from the study and given local therapy, including radical prostatectomy or external beam radiotherapy, at the discretion of the patient's physicians. if patients have evidence of response, they continue on treatment for a total of 6 cycles. if multiparametric mri demonstrates stable disease an individual risk-benefit analysis has to be performed with regard to continuing or to stopping the neoadjuvant treatment since the definition stable disease includes patients with ≤ 20% tumour shrinkage or tumour progression

Eligibility criteria:
inclusion criteria: * surgically resectable high risk prostate cancer with a 5-year relapse probability ≥ 60% according to the kattan pre-operative nomogram (cancer 2009, 115: 1005-1010) * no prior therapy for prostate cancer such as androgen deprivation therapy, radiation therapy, or chemotherapy * ecog performance status 0-1 * no evidence of active infection * hemoglobin \>9.0 g/dl * absolute neutrophil count \>1.5 x 109/l, * platelet count \>100 x 109/l, * ast/sgot and/or alt/sgpt \<2.5 x uln; * total bilirubin \<1.0 x uln, * serum creatinine \<1.5 x uln. if creatinine 1.0 - 1.5 x uln, creatinine clearance will be calculated according to ckd-epi formula and patients with creatinine clearance \<60 ml/min should be excluded) * patient information and signature of informed consent * male ≥ 18 years * patients of reproductive age must take appropriate contraceptive precautions during and for 6 months after the end of their participation in the study exclusion criteria: * evidence of lymph node, visceral or bone metastases * previous major intrapelvic surgery * previous radiation therapy to the small pelvis * any type of malignancies within the last 5 years except basalioma and non-muscle invasive urothelial cancer of the urinary bladder * previous chemotherapy with taxanes (docetaxel, paclitaxel, cabazitaxel) for any indication * hypersensitivity to the active substance or to any of the excipients * known or suspected brain metastases or leptomeningeal metastases * active or symptomatic viral hepatitis or chronic liver disease * serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection

Keywords: untreated, high risk prostate cancer
effects of preoperative oral carbohydrates loading in patients at high risk of postoperative nausea and vomiting undergoing spinal surgery

Conditions: Spinal Disease

Summary: many patients receiving opioid based analgesia after spinal surgery experience postoperative nausea and vomiting (ponv) despite prophylaxis and treatment with antiemetic agents. dehydration caused by fasting prior to surgery is associated with the development of ponv. the aim of this study is to investigate the effect of oral carbohydrates loading prior to surgery in patients at high risk of ponv undergoing spinal surgery.


Eligibility criteria:
inclusion criteria: * female patient between 20 and 65 of age with asa physical status ⅰ-ⅱ * patient scheduled for elective spine surgery * no smoking history exclusion criteria: * hepatorenal disease * bmi \> 35 kg/m2 * gastrointestinal disease * vomiting within 24h * administration of antiemetics or opioids within 24 h prior to surgery * pregnant * problem with communication

Keywords: postoperative nausea and vomiting, oral carbohydrate beverage
asian phase i study of pf-03446962

Conditions: Neoplasms

Summary: this is an asian phase 1, multi center, open label, single arm study of pf 03446962 with dose escalation and designed to define the maximum tolerated dose \[mtd\] and the recommended phase 2 dose \[rp2d\].


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of stomach cancer * advanced/metastasis solid tumor refractory or intolerant to established therapy * adequate blood chemistry, blood counts and kidney/liver function * willing to participate to study requirements and sign an informed consent document exclusion criteria: * chemotherapy, radiotherapy, or any investigational cancer therapy within 4 weeks of first dose of study medication * excessive toxicities related to prior therapies * pregnant or breastfeeding patients

Keywords: hepatocellular carcinoma advanced/metastatic solid tumors
shape:seeingtheheartwithaipoweredecho

Conditions: Cardiac Disease

Summary: establish transthoracic echocardiogram (tte) exams performed with bay labs echogps guidance technology can be used in a primary care setting to accurately identify cardiac disease. in phase i tte exams with echogps will be compared to findings from a commercially available, fda 510(k)-cleared reference device (terason usmart 3200t, point-of-care ultrasound) without echogps assistance technology. study is non-significant risk (nsr).


Eligibility criteria:
inclusion criteria: 1. patients indicated for a standard physical examination 2. patients ≥65 years old for patients in phase i, one of the following additional inclusion criteria must be present: 1. patient presenting with a new murmur, or history of a murmur but no prior echo within 3 years of the exam 2. patient presenting with shortness of breath 3. unexplained pedal edema exclusion criteria: 1. unable to lie flat for study 2. significant anatomical abnormality, recent trauma, or recent thoracic/abdominal surgery that would limit the ability to obtain adequate images 3. subjects unwilling or unable to give written informed consent 4. patients experiencing a known or suspected acute cardiac event eligibility criteria for phases ii and iii of this study will be finalized once results from phase i are available. the current plan is to have similar criteria for phases ii and iii.

Keywords: disease detection medicare aged patients routine physical examination primary care limited echocardiogram
incidence of post-operative vomitings (pov) after early refeeding in pediatric day case surgery.

Conditions: Post-operative Vomiting Incidence; Pediatric Day Case Surgery

Summary: at the child, the post-operative vomitings (pov) remain the main post-operative complication in term of frequency. they also represent the first cause of unforeseen hospitalization in day case surgery. the causes of pov are multiple, including in particular the post-operative prescription of opioids. the role of the premature refeeding remains discussed. up to the age of 4 years, acute pain is difficult to distinguish from other causes of distress (anxiety, anger but also hunger) being able to make prescribe wrongly opioids in post-operative. the main objective of this study is to estimate the pov in pediatric day case surgery after early refeeding with clear liquids in the recovery room or only in the day case wards (usual practice). the secondary objectives are to estimate the time on returning to the day case ward, at home, the post-operative opioid consumption, early refeeding adverse effects (desaturation, swallowing trouble)


Eligibility criteria:
inclusion criteria: * patient of less than 4 years old * a pediatric day case surgery scheduled exclusion criteria: * child lower age or 3 month old equal * premature child of conceptional age lower than 60 weeks * anesthetic or surgical constraint dissuading day case surgery or early refeeding * digestive pathology predisposing to the vpo (hernia hiatal, gastro-oesophageal reflux) * treatment interfering with emesis (imidazoles, neuroleptic) * period of exclusion defined by another study