Kornimate/medical-research-clean huggingface dataset:
acupuncture for analgesia in transperineal prostate biopsy: a randomized controlled trial

Conditions: Prostate Cancer; Pain Management; Acupuncture Analgesia; Prostate Biopsy

Summary: this randomized controlled trial evaluates the efficacy of acupuncture in reducing pain and improving patient experience during transperineal prostate biopsy. participants will be randomized to receive either acupuncture or sham acupuncture prior to the biopsy, in addition to standard local anesthesia. the primary outcome is pain, measured using the visual analog scale (vas), while secondary outcomes include anxiety, additional analgesic use, patient satisfaction, and adverse events.

transperineal prostate biopsy is a standard diagnostic procedure for prostate cancer, often associated with pain and anxiety. although local anesthesia is commonly used, it may not fully alleviate discomfort, and systemic medications can introduce side effects. acupuncture, a traditional chinese medicine technique, has demonstrated potential in managing procedural pain and reducing anxiety across various clinical settings. however, its specific efficacy for transperineal prostate biopsy remains underexplored. this study aims to determine whether acupuncture, administered before the biopsy, can reduce pain, decrease anxiety, and enhance patient satisfaction compared to a sham procedure. employing a randomized, single-blind design, the trial seeks to minimize bias and generate robust evidence regarding acupuncture's benefits in this context. participants will be randomly assigned to either the acupuncture group or the sham acupuncture group, with both receiving standard local anesthesia to ensure ethical care. pain will be assessed using the visual analog scale (vas) at multiple time points, and anxiety will be measured with the state-trait anxiety inventory (stai). additional outcomes include the use of supplementary analgesics, patient satisfaction, and any adverse events associated with the interventions. the study's findings could inform clinical practice by introducing a complementary, non-pharmacological option for pain management during transperineal prostate biopsy, potentially improving patient comfort and reducing reliance on systemic medications. the study protocol has been approved by the institutional review board (irb) of our hospital, and all participants will provide written informed consent prior to enrollment. data will be collected and monitored by an independent data manager to ensure accuracy and patient safety.

Eligibility criteria:
inclusion criteria: * indicated for transperineal prostate biopsy (e.g., elevated psa, abnormal digital rectal exam). * willing and able to provide written informed consent. exclusion criteria: * known allergy or contraindication to acupuncture (e.g., bleeding disorder, needle phobia). * requirement for sedation or general anesthesia. * previous experience with acupuncture treatment. * severe psychiatric disorders or diagnosed anxiety disorder.

Keywords: acupuncture prostate cancer transperineal prostat biopsy acupuncture anesthesia
obese patients with obstructive sleep apnea syndrome(osas) and exercise training

Conditions: Obesity; Sleep Apnea

Summary: the study was designed to test the following hypotheses: in obese patients with osas, the benefit of the combination of exercise training + continuous positive airway pressure (cpap) will be higher than cpap alone in term of functional capacity, metabolic, inflammatory, cardiovascular and sleep parameters and quality of life. in obese patients with osas, the benefit of training using ventilatory assistance (niv) during cycloergometer \[cycloergometer with niv\] or respiratory muscles training (spirotiger) in addition to cycloergometer \[cycloergometer + spirotiger\] will be higher than cycloergometer training alone \[cycloergometer\] in term of functional and exercise capacities. dyspnea during walking test and respiratory muscle strength at baseline could influence the response to combined exercise training such as \[cycloergometer + niv\] or \[cycloergometer + spirotiger\]

background: obesity and sleep apnea syndrome lead to metabolic troubles and increasing cardiovascular risk. furthermore, both diseases are associated with reduced exercise tolerance. we hypothesized that exercise training could be complementary to nocturnal ventilatory treatment in restoring metabolic disturbances, exercise tolerance and sleep parameters in obese patients with sas. objective: to evaluate the effect of training on exercise tolerance (walking distance and dyspnea during walk)(main objective), systemic inflammation, vascular endothelial function, insulin resistance, quality of sleep and quality of life in obese patients treated by cpap for osas (secondary objectives) methods: we proposed to conduct a controlled, randomized clinical trial comparing the efficacy of 3 different modalities of training in obese patients with sas. after a 6-week control pre-inclusion period, patients are included in either \[cycloergometer\] vs. \[cycloergometer with ventilatory assistance\] vs. \[cycloergometer + respiratory muscle exercises\]. before and after the control period, and both immediately and 9 month after training, patients perform walking test, maximal incremental test on cycloergometer, blood sampling and cardiovascular function, body composition, muscle function, quality of sleep and quality of life assessments as well as spontaneous physical activity measurement. during the 5 years following inclusion in the training program, the number of cardiovascular event is recorded every year. an interim analysis will be carried out when 30 will have completed the third evaluation session (after the training program). the peto's method will be used to correct the p-values.

Eligibility criteria:
inclusion criteria: * osas (ahi \> 30 before cpap treatment) * \> 4h/d cpap treatment adherence * obese patients with 35 \< bmi \< 45 kg/m2 * patients who give written consent * patients who subscribed social insurance exclusion criteria: * cardiovascular or respiratory failure discovered at the moment of the inclusion in the study * contraindication to exercise * pregnant or breast-feed woman * patients under guardianship * imprisoned patients
discard the curative causes of late onset epilepsy: the role of brain 18f-fdg pet

Conditions: Late Onset Epilepsy; Alzheimer Disease

Summary: etiology and cognitive prognosis in late onset epilepsy differ from young adults epilepsy. at the epilepsy onset, this is crucial to detect potential curative/treatable brain disorders. after classical investigation including morphological brain imaging, eeg, clinical assessment, which added value may have brain fdg pet in the diagnosis and prognosis evaluation?


Eligibility criteria:
inclusion criteria: * late onset épilepsy patients without lesion * epilepsy followed at the chru nancy france exclusion criteria: * epilepsy explained by cortical lesion * severe psychiatric disorders * severe addiction (alcool, drugs) * no fdg tep performed * no neuropsychological assessement after 2 years epilepsy onset

Keywords: fdg pet cognitive prognosis
characteristics and outcomes of hospitalized patients with covid-19 in spain

Conditions: Covid19

Summary: covid-19@spain is a retrospective cohort study that aims to determine the clinical characteristics of hospitalized patients with covid-19 in spain and to identify prognostic factors of mortality and the need for mechanical ventilation

covid-19@spain is a retrospective cohort study of patients admitted to spanish hospitals with laboratory-confirmed covid-19 infection by real-time polymerase chain reaction (rt-pcr) assay for severe acute respiratory syndrome coronavirus 2 (sars-cov-2). the ethics committee for research with medicines of hospital general universitario gregorio marañón approved the study and waived informed consent for the collection of clinical data. investigators from participating centers were asked to include the first consecutive hospitalized patients (up to 100) meeting the study criteria from the start of the epidemic until march 17, 2020. the data source was the electronic medical records. all data were entered directly by personnel at each institution using an online case report form (crf), that satisfied local requirements of data confidentiality. the variables registered included administrative data, epidemiological information, type of clinical specimen in which the diagnosis was confirmed, and the rt-pcr cycle threshold (ct) of the confirmatory gene. we also registered demographics, comorbidities and current medications, signs and symptoms at admission, baseline laboratory tests results, chest x-ray findings at baseline and during follow-up, complications during hospitalization, medications with potential activity against covid-19, and supportive treatments including oxygen therapy, admission to intensive care unit (icu), mechanical ventilation (intubation), and use of adjuvant anti-inflammatory medications such as tocilizumab and systemic corticosteroids. drug-related adverse events of medications for covid-19 needing discontinuation were also recorded. the clinical status of the patients as of april 17, 2020, was categorized as discharged alive (with the date of discharge), alive and currently hospitalized, and death (with the date of death). the primary endpoint is all-cause mortality at day 28, and the secondary endpoint is the need for mechanical ventilation. baseline was the date of hospital admission. the follow-up censoring date is april 17, 2020.

Eligibility criteria:
inclusion criteria: * laboratory-confirmed covid-19 infection by real-time polymerase chain reaction (rt-pcr) assay * hospital admission exclusion criteria: * none

Keywords: covid19 sars-cov-2 coronavirus
cognitive appraisals and team performance under stress in simulated trauma care

Conditions: Trauma; Stress, Emotional; Cognitive Change

Summary: medical teams work in demanding situations that are often uncertain, changeable and require accurate decision-making, skilled movement and coordinated action. how teams perform matters for patient outcomes. in addition to medical expertise, how individuals and the team collectively respond and manage the psychological stress of the situation has a significant impact on performance. one approach, which attempts to explain the facilitating and debilitating effects of stress on performance is the biopsychosocial model of challenge and threat. a challenge state occurs when perceived personal resources meet or exceed the situation's demands, whereas threat occurs when demands exceed resources. challenge states have been consistently associated with improved performance in a range of environments and activities, including medical settings. in a recent study conducted during a national simulation-based training event for residents (the simcup italia 2018) it was found that a high level of resources is associated with better performance until demands become very high. the present study builds on previous work to explore how challenge and threat states are linked to performance. it includes a more recently developed and robust measure of demands and resource appraisals. in addition, secondary aims include the exploration of how psychological variables, specifically cognitive anxiety, somatic anxiety, self-confidence and social identity (connection with other members of the medical team) are linked to challenge and threat and performance. understanding the psychological determinants of performance in critical care can provide the basis for individual and team-based interventions to improve critical care team performance.


Eligibility criteria:
inclusion criteria: * learners of the european trauma course in italy exclusion criteria: * age \< 18 years

Keywords: medical simulation, cognitive appraisal, stress psychology
study of sildenafil as a therapy for fatigue in pancreatic cancer

Conditions: Pancreatic Cancer; Cholangiocarcinoma

Summary: investigation of the effects of daily sildenafil on patients with pancreatic or cholangiocarcinoma cancer undergoing treatment.

this is a double-blinded, placebo-controlled trial in men and women, 40-75 years old, diagnosed with pancreatic or cholangiocarcinoma cancer. patients will receive placebo or sildenafil daily for 4 weeks during their initial chemotherapy cycle.

Eligibility criteria:
inclusion criteria: 1. men and women, aged 40-75 years. 2. diagnosed with stage iii or iv pancreatic or cholangiocarcinoma receiving the following therapy: * neoadjuvant chemotherapy * surgical resection followed by chemotherapy. 3. able to comprehend risks and sign a consent form. 4. performance status of 0-2. exclusion criteria: 1. significant renal or heart disease or any acute metabolic disease. 2. evidence of hepatitis as indicated by a 3-fold increase in of 2 out of 3 liver enzymes. 3. diabetes mellitus or other untreated endocrine disease. 4. recent (within 3 months) treatment with anabolic steroids. 5. ongoing anticoagulant therapy. 6. androgen secreting tumors of the ovary and adrenal or any ovarian tumor (e.g., sertoli-leydig). 7. polycystic ovary syndrome (pcos) and/or hyperthecosis. 8. non-classical adrenal hyperplasia. 9. cushing's syndrome. 10. glucocorticoid resistance. 11. pregnancy. 12. hyperprolactinoma, hypothyroidism. 13. use of nitrates. 14. use of alpha blockers. 15. use of protease inhibitors. 16. use of cytochrome p450 inhibitors. 17. systolic blood pressure \ 150, diastolic blood pressure \ 90. this range is smaller than the acceptable range stated in the prescribing information for sildenafil (\>90/50 and \<170/110). 18. peripheral vascular disease. 19. use of a phosphodiesterase 5 inhibitor. 20. any other circumstance deemed exclusionary by the pi or study physician.

Keywords: cancer pancreas cholangiocarcinoma fatigue sildenafil lean mass muscle
remotely supervised tdcs for slowing als disease progression

Conditions: Amyotrophic Lateral Sclerosis (ALS)

Summary: most als care is centered on patient support and symptom management, making rehabilitation an integral aspect for slowing disease progression, prolonging life span, and increasing quality of life. brain stimulation has been increasingly explored as a promising neuromodulatory tool to prime motor function in several neurological disorders. we propose a novel mechanism using remotely supervised brain stimulation to preserve motor function in individuals with als. this project will also aim to explore the effectiveness of brain stimulation on upper and lower motor neuron mechanisms in individuals with als.


Eligibility criteria:
inclusion criteria: * diagnosis of possible, probable, or definite amyotrophic lateral sclerosis according to el escorial revised criteria * spinal onset als with initial weakness in the upper or lower extremity. * diagnosed with als within the past 5 years * 1-2 point change in pre-slope of the alsfrs-r at time of enrollment (ratio of drop in score from 48 to the duration in months from onset of weakness) * score ≥ 2 for "swallowing" of the alsfrs-r * score ≥ 2 for "walking" of the alsfrs-r * able to provide informed consent * stable dose of riluzole, edaravone, amx0035 (relyvrio) or no medications * availability of a caregiver for remote administration of tdcs exclusion criteria: * subject has bulbar onset als * any neurological diagnosis other than als * psychiatric disorders * any other concomitant disease that affects prognosis of als inclusive of systemic disease, cardiovascular disease, hepatic or renal disorder * tracheostomal or noninvasive ventilation for more than 12 hours per day * enrollment in an on-going als pharmaceutical trial * subject plans on moving within 6 months. tms exclusion criteria: * implanted cardiac pacemaker * metal implants in the head or face * unexplained, recurring headaches * history of seizures or epilepsy * currently under medication that could increase motor excitability and lower seizure threshold * skull abnormalities or fractures * concussion within the last 6 months * currently pregnant * tdcs exclusion criteria: * skin hypersensitivity * history of contact dermatitis * history of allodynia and/or hyperalgesia * any other skin or scalp condition that could be aggravated by tdcs
an ascending, single oral dose pharmacokinetic study of 3'-deoxy-3'-fluorothymidine (flt) in asymptomatic human immunodeficiency virus (hiv)-infected subjects

Conditions: HIV Infections

Summary: to characterize the pharmacokinetics of orally administered 3'-deoxy-3'-fluorothymidine (flt), in a liquid formulation, after single doses in asymptomatic hiv-infected patients and to assess the safety and tolerance of the single oral doses of flt.


Eligibility criteria:
exclusion criteria co-existing condition: patients with the following conditions or symptoms are excluded: * oral candida infection documented by morphology or by response to antifungal therapy within 2 months prior to study entry. * temperature \> 37.8 degrees centigrade. * malignancy other than cutaneous basal cell carcinoma or cervical carcinoma in situ. * significant chronic underlying medical illnesses which would prevent continuous participation in this clinical trial. concurrent medication: excluded: - patients with the following are excluded: * significant chronic underlying medical illnesses which would prevent continuous participation in this clinical trial. * unwilling to sign informed consent. * intolerant to zidovudine (azt). * oral hairy leukoplakia at any time prior to study entry. prior medication: excluded within 7 days of study entry: * antiretroviral drugs. * immunomodulators. * excluded within 30 days of study entry: * any investigational drugs. patients have the following: * hiv seropositivity by licensed elisa test, confirmed by western blot analysis. * no symptoms as defined by: 1. normal neurological exam. 2. absence of the following: * unintentional weight loss of greater than 10 pounds or more than 10 percent of usual body weight within 2 months prior to study entry. * unexplained temperature \> 37.8 c on more than 5 consecutive days or on more than 10 days in any 30 day period in the one month prior to expected study entry. * unexplained diarrhea defined by = or \> 3 liquid stools per day persisting \> 7 days within 2 months prior to expected study entry.

Keywords: thymidine nucleosides antiviral agents
18f-sodium fluoride (naf) pet to replace bone scintigraphy: safety and efficacy assessment

Conditions: Bone Cancer; Articular Disease; Infectious Disease

Summary: 18f-sodium fluoride (18f-naf) was already investigated numerous times in the last 40 years as a pet alternative to standard 99m-technetium-derived bone scintigraphy. however, lack of universal tracer availability and higher costs contributed to the failure of 18f-naf to systematically supplant bone scintigraphy as a standard of care. recently, an isotope shortage crisis occurred and evidenced the need to have non-reactor-derived alternatives for many nuclear medicine procedures, including bone scintigraphy. since 18f-naf is cyclotron-produced, it could become a necessary alternative to bone scintigraphy in case of another worldwide isotope shortage. the study aims to evaluate the safety profile of 18f-naf injection. moreover, a patient registry will be compiled in order to perform sub-studies on 18f-naf diagnostic performance on diverse bone and articular diseases.


Eligibility criteria:
inclusion criteria: * patients for whom a 99mtc-biphosphonate bone scintigraphy is indicated; * pediatric patients for whom a 99mtc-biphosphonate bone scintigraphy is indicated for oncologic or infectious reasons * able to tolerate supine position * written consent exclusion criteria: * healthy subjects * pregnancy * unable of maintaining supine position for more than 15 minutes * refusal to sign the consent form * known allergy or hypersensitivity to 18f-naf or any of its constituants.

Keywords: 18f-naf bone scintigraphy bone diseases
dietary management of gestational diabetes in obese pregnant women

Conditions: Diabetes, Gestational; Dietary Modification; Tissue Glucose; Body Composition; Birth Weight

Summary: emom is a randomized, controlled trial to compare the effects of two different dietary interventions during pregnancy. the comparison is based on tissue glucose content (using continuous glucose monitoring system) in pregnant women and on neonate body composition. the recruited women (n=50) have early gestational diabetes mellitus (diagnosed before gestational weeks 13), are obese (bmi \>30 kg/m²) and of caucasian origin. of the study diets, one is moderately carbohydrate restricted and the other one is high on plant-based protein with an emphasis on healthy nordic foods. the study has three two-week study periods that are carried out on approximately gestational weeks 13-14 (period i), 24-25 (period ii) and 34-35 (period iii). continuous glucose monitoring and other measurements (accelerometer, 3-day food record, gut microbiota, serum lipids, metabolomics, epigenetics etc.) are done during these study periods. at the beginning of the study, before study period i, the participants are randomized to either one of the intervention diets. the first study period consists of a crossover phase in which the participants receive three days' worth of food according to one of the intervention diets (according to the randomization) after which there is a three-day wash-out period. after the wash-out period, the participants receive three days' worth of food according to the other diet. after the first study period, a nutritionist advises the lastly followed intervention diet to the participant and the diet is followed until delivery. to ensure the diet is followed, the participant gets at least five personal counselling sessions, mobile reminders, recipes and food items. after delivery, the infant's body composition, epigenetic markers of cord blood and placenta, gut microbiome and urine metabolomics are measured.


Eligibility criteria:
inclusion criteria: * early gestational diabetes (pregnancy weeks 10-15) * bmi ≥ 30 kg/m2 * pregnancy confirmed with ultrasound screening exclusion criteria: * multiparous pregnancy * food allergies or restrictions (other than lactose intolerance) * mother's or father's ethnic background other than caucasian * type 1 or type 2 diabetes * medication which affects glucose metabolism * cholesterol medication * drug or alcohol abuse * psychiatric illness which affects participation in study * factors hampering communication (e.g. lack of finnish skills)