Kornimate/medical-research-clean huggingface dataset:
inflammatory stress response in pediatric inguinal hernia repair

Conditions: Inguinal Hernia, Indirect; Children, Only; Inflammatory Response; Surgery; Interleukin-6; Tumor Necrosis Factor Alpha; C Reactive Protein; White Blood Cell Count, Leukocytes

Summary: today there are various surgical techniques for inguinal hernia. in this study, investigators want to compare the ''pirs'' operating technique laparoscopy and modified "marcy" operating technique with open inguinal access. investigators would compare both groups to find out witch one does the lesser inflammatory stress response on the organism.

inguinal hernia represents the protrusion of the abdominal cavity contents through the inguinal canal. today there are various surgical techniques for inguinal hernia. in this study, investigators want to compare two standard methods that are regularly performed at the university hospital of split at department of pediatric surgery. these are the ''pirs'' operating technique laparoscopy and modified "marcy" operating technique with open inguinal access. the choice of operating technique depends solely on the choice of a chosen pediatric surgeon. given the fact that the child is indicated for an operation, regardless of participation in the study, there are no significant risks of participating in this study, except for possible but rare complications resulting from the peripheral venous blood draw (haematoma, soreness and pain). to carry out this study, the child should be taken (drawn) 3 peripheral venous blood samples (on day of operation, 24 hours after surgery and 6 days after surgery) from which the laboratory parameters are taken and counted (leukocytes, c - reactive protein, interleukin 6 and tumor necrosis factor α). lab results would be compared between both groups to find out witch one does the lesser inflammatory stress response on the organism.

Eligibility criteria:
inclusion criteria: * male children with inguinal hernia at age of 3 to 7 * one-sided inguinal hernia exclusion criteria: * female children * recurrent hernia * bilateral hernia * age less than 3 y, more than 7 y * any general inflammatory process, illness * intraoperative complications which may interfere with inflammatory stress response

Keywords: inguinal hernia, indirect children, only inflammatory response surgery interleukin-6 tumor necrosis factor alpha c reactive protein leukocytes
application of a systematic developmental assessment to a novel population: infants with rare genetic disorders

Conditions: Genetic Disease; Genetic Syndrome; Genetic Predisposition to Disease; Development, Infant; Development, Child

Summary: the main objective of this study is to apply a well-established model of developmental surveillance (which evolved to characterize the outcomes of very low birth weight infants) to infants with genetic disorders. a novel clinical model for infants with rare genetic disorders has been created as a joint initiative between the division of newborn medicine's nicu growth and developmental support programs (nicu grads) program and the division of genetics at boston children's hospital (bch). this study plans to enroll patients with genetic syndromes seen in this clinic into a prospective, longitudinal study in order to characterize their developmental profiles and needs.

the main objective of this study is to apply a well-established model of developmental surveillance (which evolved to characterize the outcomes of very low birth weight infants) to infants with genetic disorders. a novel clinical model for infants with rare genetic disorders has been created as a joint initiative between the division of newborn medicine's nicu growth and developmental support programs (nicu grads) program and the division of genetics at boston children's hospital (bch). this study plans to enroll patients with genetic syndromes seen in this clinic into a prospective, longitudinal study in order to characterize their developmental profiles and needs. related factors such as quality of life and parental stress will also be assessed which will complement the evaluation of the role of a "developmental home" for these high risk infants. it is also hypothesized that gaps in care - mismatches between services received and services indicated based upon the developmental evaluation - will be identified. the results of this study will be used to inform future research efforts utilizing targeted approaches to improve developmental outcomes. for infants with rare genetic disorders, the aims are as follows: aim 1: characterize physical and psychosocial development using standardized longitudinal assessments. aim 2: identify developmental service needs, prescription, and utilization. aim 3: assess parental stress and health-related quality of life.

Eligibility criteria:
inclusion criteria: * eligible patients are infants under 4 years of age with genetic disorders undergoing developmental surveillance in the nicu grads program. exclusion criteria: * children 4 years of age or older will be excluded.

Keywords: genetics infant development
the study of monitoring and dosing guidance of direct oral anticoagulants based on pharmacokinetics, pharmacodynamics, and pharmacogenomics

Conditions: Pulmonary Embolism

Summary: 1. integrate pharmacokinetic-pharmacodynamic (pk-pd) modeling and pharmacogenomics techniques to develop a population pk-pd model, aiming to explore monitoring and dose guidance schemes for direct oral anticoagulants (doacs). 2. investigate the factors influencing pk-pd of doacs in the pulmonary embolism population, clarifying the correlation between genotype characteristics and clinical outcomes. 3. explore the correlation between drug concentrations, coagulation indices, and clinical outcomes of doacs, defining the indications for doacs testing and the overall monitoring process.


Eligibility criteria:
inclusion criteria: * adult patients with acute symptomatic pulmonary embolism objectively diagnosed by imaging (with or without deep vein thrombosis) who have completed anticoagulation for the acute phase and have entered the maintenance phase of anticoagulation * expected lifespan greater than 3 months * eligible for the use of xa factor inhibitors; * agreement to participate in the study, signing of informed consent, and commitment to regular follow-up. exclusion criteria: * moderate or severe liver dysfunction (child-pugh grade b or c); * severe renal impairment (crcl \< 15 ml/min); * pregnant or breastfeeding women; * tendency for spontaneous bleeding, such as coagulopathy or thrombocytopenia (plt \< 20×10\^9/l); * contraindications for the use of other xa factor inhibitors; * patients diagnosed with hereditary thrombophilia and antiphospholipid syndrome.
remote time-restricted eating delivery

Conditions: Metabolic Disturbance

Summary: this study will evaluate the implementation and effectiveness of free-living tre on biological and behavioural breast cancer risk factors.

tre is an eating pattern where individuals consume ad libitum energy intake within a set window of time, commonly 8 hours, which induces a fasting window of 16 hours per day (i.e., 16:8 tre). tre is a simple and accessible lifestyle intervention with high adherence potential that may target both biological and behavioural mechanisms of breast cancer risk.

Eligibility criteria:
inclusion criteria: * females * no cancer history * ≥50 years old * have metabolic dysfunction (defined as self-reported diagnosis of pre-diabetes, type 2 diabetes, or at least moderate canadian diabetes risk (canrisk) score) * access to an ontario lifelabs location * owns a smartphone with bluetooth capability with apple or android operating system exclusion criteria: * type 1 diabetes * taking exogenous insulin, sulfonylureas, or glp-1 receptor agonists * self-reported history of an eating disorder * bmi \<18.5 kg/m * working night or rotating shifts * eating window \<12 hours or consistently eating less than 3 meals/day in the past 3 months * major dietary changes within the past 3 months (i.e. calorie counting, ketogenic diet)
effect of banning menthol flavorant on cigarette and e-cigarette use

Conditions: Tobacco Use Disorder

Summary: in this pilot study, menthol cigarette smokers will be randomized to one of three experimental marketplaces: 1) a condition simulating a ban on menthol cigarettes but not menthol e-cigarettes (condition a); 2) a condition simulating a ban on both menthol cigarettes and menthol e-cigarettes (condition b); and 3) a condition in which menthol is not banned for either product (condition c - the control condition). all conditions would have medicinal nicotine available if subjects decide to quit tobacco products entirely. at visits occurring every two weeks over a 6 week period, subjects will receive "credits" that they could exchange for any product available in their randomized marketplace condition. outcomes include the amount of each tobacco product used.


Eligibility criteria:
inclusion criteria: * be between the ages of 18 and 64 * purchase exclusively menthol cigarettes * not currently motivated to quit smoking * smoking a minimum number of cigarettes per day exclusion criteria: * report a serious, unstable medical or psychiatric condition * use any medications that might interfere with measures to be studied (for example, medications known to affect smoking) * have used any smoking cessation therapy during the past month * regularly use any form of tobacco other than cigarettes * are pregnant or breast feeding or planning to become pregnant or breast feed during the study
study of doxorubicin in patients with metastatic breast cancer/advanced ovarian cancer

Conditions: Breast Cancer and Ovarian Cancer

Summary: this was a randomized, multi centre, open label, two treatment, two period, two sequence, single dose, crossover study, with at least 28 days washout between doses, conducted under fed (normal breakfast) conditions.


Eligibility criteria:
inclusion criteria: 1. availability of volunteer for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent. 2. patients with metastatic breast cancer/advanced ovarian cancer having age within the range of between 18-55 years. 3. subjects who had no evidence of underlying disease 4. subjects who had signed written consent form exclusion criteria: 1. females who were pregnant, breastfeeding, or are likely to become pregnant 2. subjects who had any medical condition (except metastatic breast cancer/advanced ovarian cancer) that could jeopardize their health or prejudice the results 3. subjects deemed uncooperative or noncompliant 4. smoking or consumption of any nicotine products
multi- level and integrated analysis of mechanisms underlying atrial dysfunction

Conditions: Ischemic Heart Disease

Summary: integrated and cross-disciplinary analysis of human physiology and disease provides unbiased and deeply informative insights into human health and disease. in this study the investigators will recruit patients undergoing coronary artery bypass surgery to study the atrium of the heart or the aortic wall that when diseased can cause strokes. hypothesis: systems-level analysis of the left atrium and aorta cells that integrates imaging, histological, cellular and molecular data will identify new mechanism for cardiovascular form and function.

while there are many sub-aims to this study, the overarching goal is to define molecular mechanisms underlying atrial dysfunction. here the investigator provide a power calculation based on detecting the genetic control points of gene expression (eqtls) in the human atrial fibroblast. the investigator and many others have shown that tissue-specific eqtls can be robustly identified at genome-wide significance in segregating populations of \~200. in this study the investigator propose eqtl association analysis in humans, which have previously been successfully performed in cohorts of less than 1000 subjects. the general applicability of this approach has been validated in multiple studies across multiple tissues in cohorts of between 200-1000 subjects.based on published imaging genetic studies that have been successfully applied in small cohorts (\<500) and the success of echo-based, semi-quantitative studies of ventricular dimensions, the investigator are confident that our quantitative studies of 750 individuals are powered to detect genome wide significant loci for the traits under study. despite intensive research there is a critical gap in our knowledge in the mechanisms underlying atrial fibrillation, which is a major cause of stroke and heart failure and increasingly common as it is a disease of the elderly. this project will address this important gap in our knowledge and provide new insights into disease pathogenesis with the goal of stratifying participants to prevent strokes and for treating the underlying substrate.

Eligibility criteria:
inclusion criteria: * patients undergoing elective cardiac bypass surgery during which a sample of right atrial appendage and/or aortic button can be removed. exclusion criteria: * infection within 2 weeks preceding the operation or immunosuppressive therapy. * patients not able or willing to consent for study. * previous atrial intervention. * patients who cannot be followed up. * exclude patients with significant valvular disease (any planned valvular surgery, mr \> severe, as \> severe, tr \> severe).

Keywords: ihd normal ef
a study in patients with advanced parkinson's disease to assess the relative bioavailability of levodopa administered as nd0612 subcutaneous infusion versus levodopa administered as carbidopa-levodopa enteral suspension

Conditions: Parkinson

Summary: this study will assess the relative bioavailability of s.c. infused nd0612 versus jejunally infused cles in patients with advanced pd.

this study will be an open-label, randomized, crossover study to assess the relative bioavailability of s.c. infused nd0612 versus jejunally infused cles in patients with advanced pd.

Eligibility criteria:
inclusion criteria: * patients with advanced pd treated with ld/cd at a dose of at least 800 mg ld * female patients must have a negative pregnancy test at screening and at admission. * patients must have a body mass index (bmi) within the range of 18.5 - 35 kg/m2, where bmi = body weight (kg) / height (m2) at screening. * must be willing and able to communicate and participate in the whole study. * must provide written informed consent. * must agree to use an adequate method of contraception (per local independent ethics committee requirements). * area of administration to be evaluable for local skin reaction (normal skin without skin burns, scars or large tattoos in the area of administration exclusion criteria: * any relevant medical, surgical, or psychiatric condition, laboratory value, or concomitant medication which, in the opinion of the investigator, makes the patient unsuitable for study entry or potentially unable to complete all aspects of the study. * positive serum serology for hepatitis b virus (hbv), hepatitis c virus (hcv) or human immunodeficiency virus (hiv) at the screening visit. * patients with a history of drug abuse or alcoholism within the past 12 months prior to screening or positive drugs of abuse or alcohol test result at the screening visit and/or on admission. * clinically significant electrocardiogram (ecg) rhythm abnormalities. * renal or liver dysfunction that may alter drug metabolism including: serum creatinine \>1.5 mg/dl, serum aspartate aminotransferase (ast) or alanine aminotransferase (alt) \>2 x upper limit of normal (uln), total serum bilirubin \>2.5 mg/dl. * psychiatric, neurological or behavioral disorders that may interfere with the conduct or interpretation of the study, including dementia, or patients who are considered to be violent or at suicidal risk by the investigator. * blood loss of greater than 500 ml within the previous 3 months prior to first dosing. * use of any medication from the prohibited concomitant therapies
ultrasound and psychobiological correlates of female sexual function

Conditions: Healthy

Summary: monocentric pilot interventional study. the aim of the study is to assess clitoral doppler ultrasonographic parameters in a population of sexually healthy volunteer women in order to obtain reference values. psychobiological correlates of female sexual function will also be studied through hormonal testing and psychological evaluation.


Eligibility criteria:
inclusion criteria: * sexually healthy * evidence of a personally signed and dated informed consent. exclusion criteria: * any uncontrolled or unstable, acute or chronic disease * alcohol or drugs abuse * sexual dysfunction * any overt psychiatric or psychological condition assessed through psychological evaluation and/or self-administered validated questionnaires.

Keywords: clitoris sexuality vascularization doppler ultrasound reference female pilot projects vagina/ultrasonography urethra/ultrasonography regional blood flow/physiology arteries/ultrasonography clitoris/ultrasonography reference values clitoris/blood supply
zenith® dissection endovascular system in the treatment of patients with aortic dissections

Conditions: Aortic Dissection

Summary: the zenith® dissection extended study is to collect confirmatory safety and effectiveness data on the zenith® dissection endovascular system in the treatment of acute, complicate type b aortic dissection.


Eligibility criteria:
exclusion criteria: * \< 18 years of age * other medical condition(e.g., cancer, congestive heart failure) that may cause the patient to be non-compliant with the protocol, confound the results, or is associated with limited life expectancy (i.e., \< 2 years) * pregnant, breast-feeding, or planning on becoming pregnant within 60 months * unwilling to unable to comply with the follow-up schedule * inability or refusal to give informed consent * simultaneously participating in another investigative device or drug study. (the patient must have completed the primary endpoint of any previous study at least 30 days prior to enrollment in this study)

Keywords: aorta thoracic aortic dissection type b debakey type iii endovascular
biventricular alternative pacing

Conditions: Atrioventricular Block

Summary: aim of present study is to examine the short and long-term results of pacing from right ventricular apex and to compare them with those of biventricular pacing.

in this study all subjects to be studied will have atrioventricular conduction disturbances that require permanent artificial pacing. in all subjects a biventricular pacemaker will be implanted. moreover the subjects will be randomized in a biventricular or conventional pacing mode and will be observed for a long term period.

Eligibility criteria:
inclusion criteria: * subjects between the age of 18 to 75 years with classic indication for permanent artificial pacing in which it is expected very high percentage of ventricular pacing, (pacing systoles constitute the 80% and more of the total). * physiologic or mildly affected systolic function of left ventricle, lvef\> 40%. * subject is willing and able to comply with the clinical investigational plan and to remain available for follow-up visits, through study closure. * subject (or if allowed by local law/regulations: subject's legally authorised representative) is willing and able to sign and date the study informed consent. exclusion criteria: * subjects with classic indication for biventricular pacing - (european guidelines 2007). * permanent atrial fibrillation. * cardiovascular surgery within the last three months prior to enrollment. * myocardial infarction within the last three months prior to enrollment.

Keywords: av conduction disturbances lv function biventricular pacing conductance catheters
cognitive and behavioral intervention for the management of episodic breathlessness in patients with advanced disease

Conditions: Dyspnea; Respiratory Insufficiency; Neoplasms; Pulmonary Disease, Chronic Obstructive; Lung Diseases; Heart Failure; Lung Diseases, Interstitial; Palliative Care; Palliative Medicine; Breathlessness

Summary: episodic breathlessness is a common and distressing symptom in patients with advanced disease such as cancer, chronic obstructive pulmonary disease (copd) and chronic heart failure. since the short duration of the majority of breathless episodes limits the effectiveness of pharmacological interventions (e.g. opioids), non-pharmacological management strategies play a major role. as non-pharmacological strategies patients use, for example, cognitive and behavioural methods such as breathing or relaxation techniques. the aim of the study is to test a brief cognitive and behavioural intervention for an improved management of episodic breathlessness. initially, a delphi procedure with international experts has been used to develop the brief intervention consisting of various non-pharmacological strategies to enhance the management of breathless episodes. in the single-arm therapeutic exploratory trial (phase ii), the feasibility and potential effects of the brief intervention, such as patient-reported breathlessness mastery, episodic breathlessness characteristics, quality of life, symptom burden, caregivers' burden, and breathlessness in general will be examined. the results of the study form the basis for planning and implementing a subsequent confirmatory randomized control trial (phase iii).


Eligibility criteria:
inclusion criteria: * in- and outpatients of the participating centers with episodic breathlessness due to a life-limiting progressive disease * recurrent breathlessness episodes despite optimal treatment of the underlying disease * eastern cooperative oncology group (ecog) status 0-3 * estimated life-expectancy should be at least 8 weeks as judged by the treating physician * ability to understand, read, and respond to german language * informed consent exclusion criteria: * episodic breathlessness due to reversible and treatable causes, such as acute pneumonia, pulmonary embolism, chronic hyperventilation syndrome, asthma or other reversible or unknown cause * cognitive impairment * severe current health impairments that do not allow participation after clinical evaluation by the treating physician

Keywords: clinical trial phase ii cognitive behavioral therapy feasibility studies