Kornimate/medical-research-clean huggingface dataset:
the impact of covid 19 pandemic on the training of general surgery residents

Conditions: COVID-19 Pandemic; Educational Problems

Summary: the educational process of general surgery residents is a very important step in every surgeon's career, which is often overlooked or neglected. the covid-19 pandemic has inflicted deep changes in the medical activity in general and in the training process of young doctors in particular. our study aims to assess the impact of the covid-19 pandemic on the educational process of general surgery residents, through a comparative study. the responses of resident doctors at a questionnaire, in two different time periods, will be compared: pre-covid era (december 2019) and covid era (december 2020).


Eligibility criteria:
inclusion criteria: * general surgery residents * above second year of residency * residency program in cluj-napoca medical centre exclusion criteria: * incomplete responses to the questionnaire * refusal to be included in the study
evaluation of hypo-safe hypoglycaemia alarm device - a pilot study

Conditions: Hypoglycemia

Summary: the trial aims at measuring the safety and performance of the hyposafe device.

safety: to evaluate safety issues related to implantation and use of the hyposafe hypoglycaemia alarm device performance: to evaluate the stability of the hypoglycaemia alarm device.

Eligibility criteria:
inclusion criteria: healthy control subjects or and * male and female patient with type 1 diabetes for at least one year * age 18-70 years * impaired awareness of hypoglycaemia as defined by * a score of ≥4 on the gold-scale or * two or more occasions of severe hypoglycaemia (need of help from third person) within the past 12 month * multiple injection insulin therapy or continuous insulin injection therapy * for female participants: not pregnant and, if child bearing potential, usage of reliable anti-contraceptive method during the study period exclusion criteria: * severe cardiac disease * history of myocardial infarction * cardiac arrhythmia * previous stroke or cerebral haemorrhage and any other structural cerebral disease * active cancer or cancer diagnosis within the past five years * uremia defined as s-creatinine above 3 times upper reference value * liver disease defined as s-alat above 3 times upper reference interval * inability to understand the informed consent * epilepsy * use of antiepileptic drugs for any purposes * clinical important hearing impairment * use of active implantable medical device including * pacemaker and icd-unit * cochlear implant * use of following drugs * chemotherapeutic drugs of any kind * methotrexate * third generation antipsychotic drugs (aripiprazole, quetiapine, clozapine, ziprasidone, paliperidone, risperidone, sertindole, amisulpride, olanzapine) * abuse of alcohol (defined as consumption of \> 250g alcohol (in danish: 21 "genstande") per week or abuse of any other neuroactive substances * infection at the site of device-implantation * any hemorrhagic disease * diving (snorkel diving allowed) or parachute jumping * patients that are judged incapable of understanding the patient information or who are not capable of carrying through the investigation
safety study of clinical and immune effects of phosphodiesterase 4 (pde-4) inhibitor in cutaneous lupus patients

Conditions: Discoid Lupus Erythematosus

Summary: the purpose of this study is to determine the clinical and immunological effects of the phosphodiesterase type 4 inhibitor, cc-10004, on skin inflammation associated with cutaneous lupus erythematosus.

discoid cutaneous lupus is the most common cutaneous manifestation of lupus erythematosus, a chronic, immune mediated disease of unknown etiology. the immune processes underlying cutaneous lupus remain largely unexplored, but recent evidence suggests a role for dendritic cells (dcs), type 1 interferons (ifn) and th1-type immune processes. treatment of cutaneous lupus remains limited primarily to anti-malarials, with thalidomide an effective secondary agent. however, side effects associated with these treatments are potentially problematic with chronic use. phosphodiesterases (pde) are critical enzymes that degrade camp. in particular, pde type 4 (pde4) activity is found in inflammatory and immune cells, including dcs. the immune modulator cc-10004 is a pde4 inhibitor with demonstrated low toxicity in phase i and ii clinical studies with potential efficacy in cutaneous lupus. cc-10004 is a well-tolerated, selective pde4 inhibitor with demonstrated inhibitory effects on th1-type cytokines and other inflammatory mediators and is under development for the treatment of inflammatory and immune mediated conditions. prior studies include pilot trials in psoriasis and exercise-induced asthma, with results suggesting clinical efficacy in the former study. this open label, pilot study of 16 weeks duration will explore the clinical and immune-modulating effects of cc-10004 in 10 cutaneous discoid lupus patients. patients meeting study criteria will receive the drug for 12 weeks, followed by a 4-week washout period. study visit time points will include weeks 0, 1, 2, 4, 6, 8, 10, 12 and 16, during which we will measure outcomes for clinical, immunological and safety parameters. to investigate early immunological changes occurring in response to treatment, we will also perform skin punch biopsies of lesional sites at week 0 and week 4 for immunohistochemical and molecular analysis.

Eligibility criteria:
inclusion criteria: * diagnosis of cutaneous discoid lupus by clinical and histopathological exam exclusion criteria: * systemic lupus involving the internal organs * systemic vasculitis * history of other clinically significant disease process * history of hiv, hepatitis b or c * concurrent use of immune modulating therapy * evidence of incompletely treated tuberculosis * pregnant or lactating female

Keywords: cutaneous lupus intervention discoid lupus phosphodiesterase 5 inhibitor
rtms on motor function of parkinson's disease patients with different phenotypes

Conditions: Parkinson Disease

Summary: in this study we wondered whether patients with different phenotypes of parkinson's disease respond differently to the protocol of repetitive transcranial magnetic stimulation (rtms) associated with physical therapy. furthermore, the study aims to compare the effects of rtms protocols (high and low frequency) associated with physical therapy in pd patients with different phenotypes regarding to motor performance; bradykinesia; functional mobility; balance; quality of life; perception of improvement.

after given prior informed consent, volunteers will be classified and randomized using a website (randomization.com) by a non-involved researcher. at study beginning, volunteers will be evaluated through structured questionnaire. they will be submitted to the following evaluations: (i) unified parkinson's disease rating scale (updrs); (ii) parkinson's disease sleep scale; (iii) parkinson's disease questionnaire; (iv) short version of balance evaluation systems test; (v) timed up and go; (vi) 5-times sit to stand test; (iv) patient global impression of change scale. the cortical activity of the patients will be assessed through electroencephalography and transcranial magnetic stimulation. treatment - participants will be randomly allocated to one of the following experimental protocols: (i) real high frequency rtms + physical therapy protocol; (ii) real low frequency rtms + physical therapy protocol; (iii) rtms sham + physiotherapeutic protocol. the sessions will be performed five times a week for two weeks. individuals allocated to the high frequency rtms group will be performed the following protocol: first the coil center will be positioned over cz for the first 1000 pulses. then the coil will be moved to c4 and c3, where 1000 pulses will be delivered to each hemisphere. the intensity will be set to 100% of the motor threshold. the high frequency stimulation will be delivered at 10 hz, offered in 20 50-pulse trains, with 30-second train intervals. the low frequency will be performed at 1 hz. all groups will be treated with physical therapy immediately after rtms.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of pd provided by neurologist; * aged 40 or over, of both gender; * regular antiparkinsonian pharmacological treatment; * with staging from i to iv on the modified hoehn \& yahr scale. exclusion criteria: * prior neurological diseases * metal implant in the skull and face * pacemaker * history of seizures * epilepsy * pregnancy * other disorders that affect the performance of the tests and proposed intervention * other osteomioarticular diseases in the lower limbs that interfere with performance and locomotion * submitted to previous surgical intervention for pd

Keywords: parkinson's disease
impact vr: an emotion recognition and regulation training program for youth with cd

Conditions: Conduct Disorder; Conduct Disorders in Children; Conduct Disorders in Adolescence; Callous-Unemotional Traits

Summary: conduct disorder (cd) is one of the most prevalent childhood psychiatric disorders. unfortunately, there are limited treatments available for cd. the present study aims to test an innovative virtual reality intervention called impact vr for symptom reduction in a sample of 60 youth with cd.

within the cd diagnosis, a subset of youth (12-46%) display callous-unemotional (cu) traits (termed "limited prosocial emotions"). cu traits denote additional symptoms including a lack of remorse/guilt, a callous lack of empathy, shallow affect, and/or lack of concern about performance. although both cd and cu traits are inextricably linked to poor outcomes for youth, there remains a scarcity of targeted interventions for cd and cu traits. one of the most significant challenges for treatment is that youth with cd are often perceived by providers as treatment-resistant and treatment disrupters. this leads to poor treatment retention and further isolation from treatment opportunities. further, existing interventions that target antisocial behaviors more generally are costly because they require 24/7 behavioral management therapies. impact vr is a psychoeducational intervention for improving emotion recognition and regulation, using immersive gameplay and storylines that are relevant to youth. impact vr uses evidence-based cognitive and dialectical behavioral approaches to improve emotion regulation. at the center of impact vr is an individualized training program that teaches youth to effectively identify emotional expressions in others.

Eligibility criteria:
inclusion criteria: * aged 10-17 years old * identified through the trinetx database as having a conduct disorder diagnosis * english speaking exclusion criteria: * youth aged \ 18 years old * non-english speaking * youth of caregivers younger than 18 years old.

Keywords: conduct problems
peritonitis and loss of residual renal function, technique failure and mortality in peritoneal dialysis patients

Conditions: Loss of Residual Renal Function; Technique Failure in Peritoneal Dialysis

Summary: the primary objective is to analyze peritonitis rate and peritonitis bacteriology as risk factors for loss of residual renal function, technique failure and mortality in chronic kidney disease patients. secondary objectives are: to know the current rate of peritonitis in peritoneal dialysis population and to understand the bacteriological profile of peritonitis. to know the rate and risk factors other than peritonitis involved in the loss of residual renal function. to analyze the utility of alternative diagnostic tests, such as reagent strips, for early detection of peritonitis when traditional tests are not available. to analyze the simultaneous measurement of serum creatinine and cystatin-c as alternative measurements of peritoneal clearance and residual renal function.


Eligibility criteria:
inclusion criteria:inclusion criteria include: adult patients with signed informed consent given; there should not be selection for age, gender, primary cause of renal disease. - exclusion criteria:patients will not be included if they were previously in hemodialysis or received renal transplant. patients will also be excluded if they are on immunosuppressive therapy, have diagnosis of cancer, or are seropositive for hiv or hepatitis. -

Keywords: peritonitis loss of residual renal function technique survival
safety and efficacy study of kai-1678 to treat pain in subjects with postherpetic neuralgia

Conditions: Postherpetic Neuralgia

Summary: the purpose of this study is to determine whether kai-1678 is effective in the treatment of postherpetic neuralgia pain


Eligibility criteria:
inclusion criteria: * diagnosis of phn with pain for at least 3 months after segmental herpes zoster eruption * pain score at least 4 on 11-point numerical rating scale (0-10) * stable doses of analgesic medications for at least 1 month" exclusion criteria: * diagnosis of phn with pain for at least 3 months after segmental herpes zoster eruption * pain score at least 4 on 11-point numerical rating scale (0-10) * stable doses of analgesic medications for at least 1 month"

Keywords: lidocaine lignocaine analgesics. non-narcotic / therapeutic use neuralgia, postherpetic pain pain measurement / drug effect pain postoperative / drug therapy phn
a study of orforglipron for the maintenance of body weight reduction in participants who have obesity or overweight with weight-related comorbidities (attain-maintain)

Conditions: Obesity; Overweight

Summary: the main purpose of this study is to evaluate the efficacy and safety of orforglipron on maintenance of body weight reduction.

all enrolled participants will have completed surmount-5 (i8f-mc-gphj; nct05822830) on treatment and meet further eligibility and randomization criteria. all endpoints for this study will be evaluated separately per each intervention arm of surmount-5.

Eligibility criteria:
inclusion criteria: * have completed the surmount-5 study on study treatment exclusion criteria: * have type 1 diabetes, type 2 diabetes, or any other types of diabetes, history of ketoacidosis, or hyperosmolar state/coma * have a prior or planned surgical treatment for obesity * have acute or chronic hepatitis * have a history of acute or chronic pancreatitis

Keywords: maintenance weight maintenance body weight changes weight loss incretins hormones hormone substitutes hormone antagonists physiological effects of drugs
safety, efficacy and pharmacokinetics study of ald518 in patients with active rheumatoid arthritis

Conditions: Arthritis, Rheumatoid

Summary: the purpose of this study is to determine the safety and efficacy of ald518 in three different doses in patients who have not had an adequate response to methotrexate.

this will be a phase ii, parallel-group, double-blind, randomized, placebo-controlled study of ald518 in patients with active ra with an inadequate response to methotrexate. enrolled patients will be screened within a 4-week period (day -35 to -7). within a 12-day period (day-14 to -3) before initial dosing on day 1 patients will be randomized to one of the following four treatment groups: group a: 2x ald518 80 mg group b: 2x ald518 160 mg group c: 2x ald518 320 mg group d: 2x placebo in all treatment groups patients will continue to take a stable dose of methotrexate. there will be a total of 11 visits. the total duration of the patient study participation will be approximately 16 weeks (excluding the screening period).

Eligibility criteria:
inclusion criteria: * active rheumatoid arthritis for at least 16 weeks duration * have a c-reactive protein (crp) of ≥ 10mg/l * have a stable dose of methotrexate (≥ 10mg/week) for at least 3 months exclusion criteria: * arthritis onset prior to 16 years old * received any biologic therapy in the previous 12 months * a history of or currently have active tuberculosis * any clinically significant concurrent medical condition
pragmatic clinical trial of two recommendations regarding alcohol consumption: a pilot study nameti_alcohol

Conditions: Alcohol Drinking

Summary: nameti-alcohol, from the acronym for navarra medical trialist initiative, is a pilot study in which two patterns of alcohol consumption, abstention and mediterranean alcohol-drinking pattern, and their effects on health in the short and medium term will be compared.

background: alcohol is the most consumed psychoactive substance in spain. in 2016 it was the seventh leading risk factor for death and disability-adjusted lost years worldwide, and the first one in people between 15 and 49 years old.in the scientific community there is some controversy about what would be the best approach to face this great problem. on the one hand, there is evidence to recommend that there is no safe level of alcohol. however, on the other hand, there are studies that demonstrate the protective role of a moderate alcohol consumption. in this pilot study both options will be compared. methods: it is intended to recruit a total of 100 participants, including two observational cohorts of abstainers and drinkers. the intervention will be carried out in drinkers willing to change their alcohol consumption, divided into 2 groups of 50 participants, the abstention group and the mediterranean alcohol-drinking pattern group. the mediterranean alcohol-drinking pattern includes 5 aspects: moderate alcohol consumption (maximum of 1 drinks/day for women and 2 drinks/day for men), spread consumption throughout the week, drink with meals and never with an empty stomach, prefer wine and mainly red wine, as well as completely avoid episodes of binge-drinking. the main objective will be to compare the short and medium term effects on health of both patterns.

Eligibility criteria:
inclusion criteria: * consuming more than 3 drinks a week (except for the abstention-control arm) exclusion criteria: * sever chronic disease (cancer, cardiovascular disease, chronic hepatitis and mental illness) * pregnant women or breastfeeding * family or personal history of addiction, alcoholism or alcohol abuse
medical and surgical management of patients with brain metastases

Conditions: Central Nervous System Tumor

Summary: the integrated cancer research site (siric) of montpellier proposes to develop a prospective and regional clinical database project and regional biological collection (blood and tumor samples), which is an expanding data collection designed to contribute to a better understand the patient's management with brain metastases including quality of life and neuropsychological/cognitive aspects.

brain metastases (bm) represent the first cause of tumors of the central nervous system. mortality, morbidity (cognitive disorders, neurological deficits, etc.) and their consequences on the quantity and the quality of life are very high. bm represent a real public health problem. the incidence is increasing related to the ageing of the population and the increase of cancer patient's survival rate. the medico-surgical care has highly evolved (neurosurgical progress, radiosurgery, stereotaxic radiotherapy and new chemo and targeted therapy). every histological or biological profile requires a specific evaluation, and management. clinical trials are the reference to establish the efficacy and the toxicity of the new processes, but usually answer only at a single question and for very selected patients. for this reason, the siric montpellier cancer proposes to develop a prospective and regional clinical database project and regional biological collection (blood and tumor samples), which is an expanding data collection designed to contribute to a better understand the patient's management with brain metastases including quality of life and neuropsychological/cognitive aspects.

Eligibility criteria:
inclusion criteria: 1. adult ≥ 18 years 2. radiological diagnosis of brain metastases 3. patient eligible for neurosurgical exeresis or treatment by radio-surgery 4. patient treated in a neurosurgery center of the languedoc-roussillon region (whatever therapeutic treatment realized on primary tumor) 5. present brain metastases not previously treated 6. signed informed consent 7. patient affiliated to a national insurance system or beneficiary of such a system exclusion criteria: 1. patient with primary brain tumor 2. impossibility to be regularly monitored for psychological, family, social, or geographical reasons 3. subject under guardianship

Keywords: nervous central tumor system
effects of prj-205 on performance in trained young subjects

Conditions: Healthy

Summary: compare a dietary supplement (prj-205) and placebo during 1 or 4 days on aerobic exercise performance, oxidative stress and muscle damage. the hypothesis is that supplementation with prj-205 improve aerobic performance

twenty young active males will be recruited and randomized to either placebo or prj-205. subjects will take the designated treatment in an acute dosage and chronically, 4 days of treatment. they will undergo 3 exercise tasks (before the administration of the product, 1.5h after the acute administration of the product and after 4 days of treatment). vo2max and anaerobic threshold will be measured during the tests. blood samples will be taken to measure muscle damage and oxidative stress.

Eligibility criteria:
inclusion criteria: * male * healthy * physically active exclusion criteria: * known cardiovascular, pulmonary or metabolic disease * any medical condition that could affect the development and safety of the exercise task

Keywords: performance
knowledge and perceptions about human papillomavirus and cervical cancer risk among young adults

Conditions: Cervical Cancer; Precancerous Condition

Summary: rationale: learning about young adults' knowledge and perceptions about risk factors for the human papilloma virus and cervical cancer may help doctors learn more about how to prevent human papilloma virus infection and cervical cancer in the future. purpose: this clinical trial is studying knowledge and perceptions of the risk factors for human papilloma virus infection and cervical cancer in young adults.

objectives: * describe the socio-demographic context of college students in an urban midwestern setting. * assess knowledge of the human papillomavirus (hpv) and cervical cancer in these participants. * assess the population's perception of hpv risk. * assess the prevalence of risk behaviors that may place this population at risk for hpv. * identify the best predictors of hpv knowledge and cervical cancer knowledge. * assess vaccine knowledge and acceptance in these participants. outline: participants complete the young adult survey online documenting demographic data; sexual history (i.e., whether they ever had sex, age of first sexual encounter, number of life time partners, condom use, sexually transmitted diseases \[stds\], and pregnancy history); cigarette use; current and past drug use; knowledge of human papillomavirus (hpv) and cervical cancer; past history of pap tests and std screenings; attitudes towards hpv testing; vaccine knowledge and acceptability; sources of information about hpv; source of information about cervical cancer; identification of common stds; perceived risk of acquiring stds; perceived risk of acquiring hpv; social support; and religion.

Eligibility criteria:
disease characteristics: * currently enrolled in a college, university, or community college in the greater cleveland metropolitan area * currently single and never married patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: cervical cancer human papilloma virus infection