Kornimate/medical-research-clean huggingface dataset:
head-to-head comparison of [18f]f-psma-n5 with [68ga]ga-psma-11 pet/ct in pca diagnosis, recurrence, and metastasis

Conditions: Prostate Cancer; PET/CT

Summary: to prospectively evaluate the radiodrug biodistribution of a novel pet imaging agent \[18f\]f-psma-n5 in different organs of prostate cancer patients and its diagnostic efficacy in the diagnosis, recurrence and metastasis of prostate cancer, and to compare with \[68ga\]ga-psma-11.

\[18f\]f-psma-n5 pet/ct was used for initial assessment of prostate cancer or detection of recurrence. the maximum standardized uptake value (suvmax) was used to evaluate tumor uptake. the sensitivity, specificity, the number and accuracy of lesions identified and the distribution of lesions in each organ were calculated and compared with those of \[68ga\]ga-psma-11 pet/ct.

Eligibility criteria:
inclusion criteria: * aged from 18 to 90 years old; * complete mri images and clinical data (such as psa level, gleason grade, etc.); * prostate cancer detected by psa or imaging examination, or clinically suspected recurrence after standardized treatment; * simultaneous \[18f\]f-psma-n5 and \[68ga\]ga-psma-11 examinations within two weeks; * willing to undergo surgery or needle biopsy for pathological examination after examination, or confirmed as prostate cancer by histopathology before or after treatment; * sign informed consent. exclusion criteria: * patients who cannot cooperate with the examination; * concurrent malignant tumors; * previous alcohol allergy; * patients with liver and kidney dysfunction; * other circumstances deemed by the investigator to be inappropriate for trial participation.
a study evaluating efficacy of abt-888 in combination with temozolomide in metastatic melanoma

Conditions: Melanoma; Metastatic Melanoma; Skin Cancer

Summary: the purpose of this study is to evaluate the efficacy of abt-888 in combination with temozolomide versus temozolomide alone in subjects with metastatic melanoma.


Eligibility criteria:
inclusion criteria: * histologically (or cytologically) confirmed metastatic melanoma. * unresectable stage iii or stage iv metastatic melanoma. * measurable disease by response evaluation criteria in solid tumors (recist) criteria. * subjects with no history of brain metastases demonstrated by a baseline mri, or subjects with a history of previously treated brain metastases who have history of operable/srs treatable brain metastases and completed surgical resection/stereotactic radiosurgery with or without adjuvant whole brain radiation at least 28 days prior to day 1; have baseline mri that shows no evidence of active intercranial disease; have discontinued taking medications for symptom management of brain metastases at least 7 days prior to day 1 * 28 days since prior anti-cancer therapy. * eastern cooperative oncology group (ecog) performance score of 0-1. * adequate hematologic, renal and hepatic function. * partial thromboplastin time (ptt) is \<= 1.5 x upper normal limit of institution's normal range and international normalized ratio (inr) \< 1.5. * subject's with significant fluid retention may be allowed at the discretion of the investigator. * life expectancy \> 12 weeks. * females must not be pregnant. * voluntarily signed informed consent. exclusion criteria: * lactate dehydrogenase (ldh) \> 2 x upper limit of normal (uln). * ocular malignant melanoma. * history of central nervous system metastases or leptomeningeal disease. * prior treatment with dacarbazine (dtic) or temozolomide (tmz). * prior dna damaging agents or cytotoxic chemotherapy. * prior whole brain radiation therapy (with exceptions). * received an investigational agent within 28 days of study. * history of seizure disorder and/or taking medication for seizure disorder. * active malignancy within the past 5 years, except cervical cancer in situ, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin. * medical condition that would cause a high risk for toxicities.

Keywords: temozolomide skin cancer melanoma metastatic melanoma abt-888 mm
standard disease activity parameters and step activity in patients with rheumatoid arthritis receiving etanercept

Conditions: Rheumatoid Arthritis

Summary: data on activities of daily living in patients with rheumatoid arthritis are assessed mainly be the health assessment questionnaire (haq). the haq generates data by subjective variables. it would be desirable and advantageous to add objective tools reflecting patients' activities to the outcome parameters in rheumatoid arthritis. the stepwatch™ activity monitor (sam) in an ankle worn step counter and an accurate instrument to measure real world ambulatory activity. the investigators purpose was to investigate whether activities of daily living measured by sam increase during a therapy with the tnf-alpha inhibitor etanercept in patients with active rheumatoid arthritis (ra).

in the past decade treatment strategies for rheumatoid arthritis (ra) have changed dramatically. today far more therapeutic options are available. patients are being treated earlier and more aggressive than in the past. these processes have had an influence on the outcome of patients with ra and on the way they are being evaluated. outcome variables are disease aspects or consequences that develop over the course of ra. the haq score has been shown to be a good predictor of patients outcome in ra. however, the haq ist a questionnaire and the score is influenced by subjective factors. the step watch activity monitor (sam)is a highly accurate accelerometer-based step monitor. the sam provides a detailed profile of the number of steps taken by a subject. it is a small unobtrusive device which is worn laterally at the right ankle. it weights only 65 grams and uses 2d accelerometry. the sam can provide objective information about activities of daily living. etanercept is a recombinant fully human tnf-receptor p75-fc fusion protein. numerous studies with etanercept have shown the clinical efficacy. this can be demonstrated by various disease activity scores (e.g the das28). in addition there is strong evidence that etanercept improves disability measured by the haq. there are only few publications reporting about measuring physical activity in patients with joint diseases; all of these include patients with osteoarthritis. our aim is to include patients with active ra who receive etanercept. these patients are asked to wear the sam for 7 days before treatment and 4 weeks and 12 weeks after initiation of therapy with etanercept. the step activity measured by the sam will be correlated with the the clinical sore das28 and the haq.

Eligibility criteria:
inclusion criteria: * patients with active rheumatoid arthritis (disease activity score -das28 \> 3.2) who are eligible to a treatment with etanercept. * age 18 and older * male or female exclusion criteria: * contraindications against a therapy with etanercept * patients not able to comply with the requirements of the protocol

Keywords: rheumatoid arthritis etanercept step activity measure
non-interventional study of lenalidomide / dexamethasone as first line therapy in patients with multiple myeloma

Conditions: Multiple Myeloma

Summary: the objective of this non-interventional study is to explore the safety, effectiveness and quality of life of lenalidomide / dexamethasone as first line treatment for transplant-ineligible patients with multiple myeloma in a real life setting.

the introduction of new drugs that can be differently combined with conventional chemotherapy or low-dose dexamethasone has changed substantially the treatment paradigm for patients with multiple myeloma. a variety of treatment options is now available for elderly patients. to compare the efficacy and safety of continuous lenalidomide in combination with low-dose dexamethasone (rd) until progression vs. rd for 18 cycles/72 weeks (rd18) vs. melphalan, prednisone and thalidomide (mpt) for 12 cycles/72 weeks a multicenter, open-label phase iii study (mm-020/ifm 07-01, first trial) was performed in transplant ineligible patients. after market approval of lenalidomide for previously untreated transplant-ineligible patients with multiple myeloma, the purpose of the first-nis is to evaluate the safety, effectiveness and quality of life of lenalidomide in combination with dexamethasone as first line treatment of multiple myeloma in a real life setting.

Eligibility criteria:
inclusion criteria: * diagnosis of multiple myeloma (2008 who classification) requiring treatment (as defined by imwg) * indication for treatment as assessed by the treating physician * decision for first line combination therapy with lenalidomide and low-dose dexamethasone * no previous systemic therapy for multiple myeloma * ineligibility for transplantation * aged 18 years or older * written informed consent signed * the conditions of the risk management plan/pregnancy prevention program (refer to the smpc revlimid®) must be followed by female and male patients * other criteria according to the smpc. special warnings and precautions of the smpc have to be considered by the treating physician exclusion criteria: * pregnant or breast-feeding women * any objections or contraindications according to the smpc
effect of physical activity following thoracic mobilization on heart rate variability and pressure pain threshold.

Conditions: Healthy

Summary: comparison of the effects of physical activity (treadmill running) plus thoracic mobilization, physical activity only or a placebo intervention (only manual contact thoracic mobilization), on heart rate variability and pressure pain threshold.


Eligibility criteria:
inclusion criteria: * asymptomatic subjects * sedentary exclusion criteria: * spinal pain * historic of trauma/surgery to the spine * diabetes * hypo/hyperthyroidism * alcoholic * smoker * hypertension

Keywords: asymptomatic individuals
detailed clinical and mri characteristics in primary non-traumatic convexity subarachnoid haemorrhage elderly patients.

Conditions: Cerebral Amyloid Angiopathy; Subarachnoid Hemorrhage

Summary: transient focal neurological episode (tfne) is the most frequent presenting symptom of convexity subarachnoid haemorrhage (csah) in elderly patients with non-traumatic csah with suspected, possible or probable cerebral amyloid angiopathy (caa). the aim of our study was to analyse in detail clinical and mri characteristics in these patients. methods: we performed a retrospective study analysing baseline, acute clinical symptom (tfne and headache), and mri characteristics (acute csah and chronic caa features) of consecutive elderly (≥55 years) patients, recruited and registered in the stroke database, between june 2008 and october 2020 of two centres (nîmes and montpellier university hospital, france), presenting with csah with suspected, possible, or probable caa.


Eligibility criteria:
inclusion criteria: * ≥55 years of age, * acute symptomatic csah based on flair and t2\*-weighted imaging performed within one month of symptom onset, recent trauma, * anticoagulation treatment, pathological blood coagulation tests (activated partial thromboplastin time \[aptt\] ratio=patient's aptt/normal control aptt\] \>1.2; or partial thromboplastin time \[ptt\] \<75%) or platelet count (\<100 x 109/l), exclusion criteria: * exclusion of underlying non-caa csah causes (e.g. reversible cerebral vasoconstriction syndrome, trauma, cerebral venous sinus thrombosus, aneurysm, primary angiitis of the central nervous system, anticoagulation treatment, pathological blood coagulation tests)
clinical trial to evaluate the effect of an extract of sclerocaya birrea on prediabetic subjects

Conditions: PreDiabetes

Summary: it consists in the intake, during a period of 10 weeks, of a nutraceutical (natural extract of sclerocarya birrea). it is a clinical trial, during which certain parameters of the glucidic metabolism will be measured analytically. other secondary variables such as lipid profile, inflammatory markers, blood pressure, endothelial function and body composition will also be determined.


Eligibility criteria:
inclusion criteria: * age: 18-65 years. * diagnosis of prediabetes according to the american diabetes association. * altered fasting glucose (95-125 mg / dl). * glucose intolerance (oral glucose tolerance test with glycemia at 2 hours between 140 - 199 mg / dl). * hemoglobin glycated between 5.7 and 6.4%. * subjects with body mass index between 18-35 kg / m2. * stable food habits: there is no gain or weight loss of more than 5 kg in the ten weeks. * i do not consume foods rich in screrocaria birrea. exclusion criteria: * subjects with a history of any type of liver or kidney pathology. * use of medications that may interfere with glucose metabolism. * consumption of alcohol greater than 20 g / day. * history of allergic hypersensitivity or poor tolerance to any component of the products under study. * participation in another clinical trial in the three months prior to the study * lack of will or inability to comply with clinical trial procedures. * pregnancy.
predictive role of hrv for ponv in laparoscopic cholecystectomy

Conditions: Postoperative Nausea and Vomiting (PONV); Heart Rate Variability (HRV); Laparoscopic Cholecystectomy

Summary: postoperative nausea and vomiting (ponv) are among the most common complications following general anesthesia (ga), significantly affecting patient comfort and recovery. although various risk factors for ponv have been identified-such as female sex, non-smoking status, and history of motion sickness-these predictors are not always sufficient to determine individual risk accurately. heart rate variability (hrv) reflects autonomic nervous system (ans) balance and has been proposed as a potential physiological biomarker for predicting ponv. reduced hrv is associated with increased vagal imbalance, which may contribute to gastrointestinal (gi) dysregulation and ponv. this prospective observational study aims to investigate the predictive value of hrv in estimating the incidence and severity of ponv in female patients undergoing elective laparoscopic cholecystectomy (lc). a total of 110 participants will be enrolled, and preoperative and early postoperative hrv measurements will be obtained using a validated chest-strap heart rate monitor (polar h10). hrv parameters, including the standard deviation of normal-to-normal intervals (sdnn), the root mean square of successive differences (rmssd), and the low-frequency/high-frequency (lf/hf) ratio, will be analyzed via the elite hrv application. standardized anesthesia, analgesia, and antiemetic protocols will be used for all participants. ponv severity will be assessed over the first 24 hours postoperatively using a 4-point scale. the primary objective is to evaluate whether preoperative hrv can predict ponv occurrence. secondary outcomes include correlations between hrv parameters and ponv severity.


Eligibility criteria:
inclusion criteria: * female patients aged 18 to 65 years * scheduled for elective laparoscopic cholecystectomy * american society of anesthesiologists (asa) physical status i-ii * non-smokers * able and willing to provide written informed consent exclusion criteria: * history of cardiovascular, neurological, or gastrointestinal disease * use of medications affecting hrv (e.g., antihypertensives, diuretics, atropine, antidepressants, antipsychotics, steroids) * presence of systemic diseases that may affect ponv risk * inability to comply with study procedures
therapeutic antioxidant supplementation

Conditions: Superficial Siderosis

Summary: a remotely administered study, non-randomized, non-blinded, controlled parallel assignment phase 2 trial to determine if oral inosine or inositol hexaphosphate will provide an effective long-term therapy to combat or slow neural damage progression either concurrently with existing iron chelation therapy or during the natural course of the disorder. clinical changes in hearing, balance, and mobility, and cognition will be assessed for 36 months through patient-reported outcomes of study assigned assessments.

capsules containing over-the-counter dietary supplement formulas of inosine 500 mg or 500 mg of inositol hexaphosphate(ip6) will be taken orally, two capsules two times per day for 36 months. initial screening will determine patient arm assignment. before dosing begins, patients will submit copies of previous audiogram results (3yrs), radiology reports (3yrs), and mri series (3yrs) if available and complete baseline assessment activities: montreal cognitive assessment (moca) administered remotely, timed up, and go (tug), 2-minute walk test (2-mwt), the activities-specific balance confidence (abc) scale, iss-qol (custom) patient outcome reported assessment will take place four times: baseline, end-of-year 1 (12mo), end-of-year 2 (24mo), end-of-study (36mo).

Eligibility criteria:
inclusion criteria: confirmed diagnosis of iss (superficial siderosis of the cns) no illegal drug use no history of myocardial infarction or stroke no history of severe chronic obstructive pulmonary disease can safely swallow large capsules exhibits at least one confirmed iss related symptom: hearing loss, balance, memory/cognitive problems does not have a known hypersensitivity or intolerance to any study antioxidant has not taken part in another treatment study for any condition within the last 30 days (about four and a half weeks) not currently pregnant or breastfeeding exclusion criteria: inosine arm exclusion : diagnosed with urate urolithiasis, or recurrent urolithiasis, all unknown type history of gout history of kidney stones p6 arm exclusion long-term anticoagulant known or suspected active bleed into the cns currently undergoing deferiprone chelation therapy plan to begin deferiprone chelation therapy within three years -

Keywords: hemosiderin iron toxicity superficial siderosis of the cns infratentorial superficial siderosis neurodegenerative disorder subpial
perioperative anxiety risk factors in parents of children undergoing thoracic surgery

Conditions: Anxiety State; Anxiety Postoperative; Parents; Surgery; Thoracic; Satisfaction

Summary: risk factors associated with perioperative anxiety in parents of pediatric patients undergoing thoracic surgery are unknown. it is therefore necessary to identify them in order to better understand, above all, modifiable factors. this will allow the implementation of psychological interventions tailored to the individual needs of parents to strengthen their coping mechanisms before surgery, and thus facilitate the recovery process of their children after surgery. the purpose of the study is: 1. assessment of the level of anxiety experienced by parents before and after thoracic surgery, 2. assessment of risk factors for parents' perioperative anxiety, 3. assessment of the relationship between parents' perioperative anxiety and satisfaction with postoperative analgesia

according to the literature, parents of children undergoing various types of surgical procedures are accompanied by high levels of anxiety. it was found that the level of anxiety is higher in female parents and is related to the child's age, fear of postoperative pain in children, the scope of information about the course of surgery and anesthesia, and potential complications that may occur during and after the child's operation. parental anxiety correlates positively with child anxiety. high levels of anxiety in children can lead to many undesirable clinical, psychological and behavioral symptoms during hospitalization (delirium, increased postoperative pain, greater need for analgesia) and after discharge from the hospital (separation anxiety, sleep disorders, aggression, enuresis).

Eligibility criteria:
inclusion criteria: * parent of child \<18 years * parent of child undergoing thoracic surgery * parent of child with intravenous or epidural postoperative analgesia * parent of child with 1-3 score according to the american society of anesthesiologists exclusion criteria: * a parent of a nationality other than polish * difficult communication with parent * parent of a child undergoing oncological treatment * parent of a child without chest drainage * lack of parental consent.

Keywords: anxiety, parents, thoracic surgery, perioperative, parents' satisfaction
safety and efficacy of eszopiclone in patients with generalized anxiety disorder

Conditions: Insomnia; Generalized Anxiety Disorder

Summary: to determine the safety and efficacy of eszopiclone as adjunctive therapy in the treatment of insomnia in patients with insomnia related to generalized anxiety disorder. all subjects will receive an approved anxiolytic agent and will be randomized to nightly therapy with either eszopiclone or placebo.

an 8-week, randomized, double-blind, placebo-controlled, parallel-group adjunctive therapy trial. the study consists of subjects with insomnia related to generalized anxiety disorder who will be treated for 10 weeks with open-label escitalopram oxalate 10 mg/day at bedtime, and randomized to receive either eszopiclone 3 mg nightly or placebo nightly for 8 weeks. this study was previously posted by sepracor inc. in october 2009, sepracor inc. was acquired by dainippon sumitomo pharma., and in october 2010, sepracor inc's name was changed to sunovion pharmaceuticals inc.

Eligibility criteria:
* subjects, between the ages of 18 and 64 years inclusive * subjects with generalized anxiety disorder (gad) * subjects with insomnia related to gad.

Keywords: insomnia anxiety generalized anxiety disorder
a study to evaluate the safety and tolerability of lenvatinib in participants with advanced or unresectable hepatocellular carcinoma

Conditions: Carcinoma, Hepatocellular

Summary: the primary purpose of this study is to further characterise the hepatotoxicity in participants with advanced or unresectable hepatocellular carcinoma (hcc) treated with lenvatinib, and to further characterise the overall safety profile (serious adverse events \[saes\], grade 3 to 5 adverse events \[aes\], dose modifications and discontinuations due to aes) in participants with advanced or unresectable hcc treated with lenvatinib.


Eligibility criteria:
inclusion criteria: 1. participants with advanced or unresectable hcc for whom a decision has been made by the treating physician (at their discretion) to initiate lenvatinib or sorafenib treatment, within the prescribing conditions of the approved product label 2. participants must provide signed informed consent to participate in the study within 31 days of initiating treatment with lenvatinib or sorafenib exclusion criteria: none

Keywords: lenvatinib advanced or unresectable carcinoma hepatocellular e7080
trial of pemetrexed with or without pf-3512676 in advanced non-small cell lung cancer

Conditions: Carcinoma, Non-Small Cell Lung

Summary: to assess the efficacy and safety of pf-3512676 administered in combination with pemetrexed for the treatment of patients with locally advanced or metastatic nsclc who have failed one prior chemotherapy regimen

pf-3512676 dosing was stopped 21 june 2007 when pfizer decided to stop the administration of pf-3512676 in all trials which combined pf-3512676 with cytotoxic chemotherapy. the decision was made subsequent to dsmc recommendation to close two phase iii randomized trials in non-small cell lung cancer which also combined pf-3512676 with cytotoxic chemotherapy, citing lack of efficacy concerns as the primary reason with safety issues (sepsis, thrombocytopenia) also contributing to the decision. subjects were allowed to complete standard of care treatment and protocol follow-up. data collection was completed on 31 january 2008.

Eligibility criteria:
inclusion criteria: * locally advanced or metastatic nsclc * measurable disease * ecog ps 0 or 1 exclusion criteria: * known cns metastasis * pre-existing autoimmune or antibody mediated disease

Keywords: advanced carcinoma, non-small cell lung cancer, phase ii, pemetrexed, alimta, pf-3512676, immunotherapy, immunomodulator