Kornimate/medical-research-clean huggingface dataset:
real-life experience in brazil in patients with castration-resistant prostate cancer treated with olaparib+abiraterone

Conditions: Prostatic Neoplasms

Summary: proceed is an observational study assessing real world clinical endpoints and demographic characteristics in patients with castration-resistant prostate cancer treated with olaparib+abiraterone.

proceed is an observational, longitudinal study with prospective data from brazilian participating sites, so as to generate real-world data. 10 brazilian oncology sites are estimated to participate in the study. each site will have participating investigators in charge and a proper technical team who will be in charge of data from each service. for this study, a convenience sample will be adopted, with an expected 2-year recruitment of 80 patients. the protocol was created in germany and other countries could use it, with the potential for data from other countries to be pooled for analysis. recruitment to each subgroup will be monitored every 3 months and feasibility for continued enrolment will be assessed after 1 year of recruitment (at months 3 and 6, recruitment will be evaluated for proper site selection); if \<20 patients have only been enrolled in a particular subgroup after 1 year, the study team will assess feasibility of pooling data from other countries to allow for at least 40 patients in a pooled analysis for that subgroup. the study plans to recruit patients for no more than 2 years and to follow patients from the start of olaparib to 1 year after last patient inclusion (lpi). data will be collected from the medical record through an electronic case report form (ecrf). participating physicians will be responsible for ensuring that all necessary data are collected and entered in the ecrf. data compilation will be performed by the principal investigator and statistical analysis will be performed by the statistics team appointed by the academic research organization (aro). the target sample size of 80 patients in brazil is based in a 24-month recruitment period. in order to avoid unnecessary imprecision for the subgroup previously exposed to a new hormonal agent, a minimum enrolment of 50% (40 patients) of the total sample size will be imposed for this subgroup. estimation is determined based on the primary objective of the ttd event-free rate; the main measure of interest is at 6 months for patients previously exposed to nha and 12 months for patients naïve to nha. assuming a 6- month ttd event-free rate is of approximately 50% for patients previously exposed to new hormonal agent, with a sample size of 40 patients in this subgroup, the precision would be +/- 15,5%.

Eligibility criteria:
inclusion criteria: 1. willing to provide written informed consent; 2. 18 years or older; 3. documented histology or cytology of pca, adenocarcinoma; 4. documented as mcrpc; 5. olaparib+abiraterone started after the activation of the research site. exclusion criteria: patients participating in a clinical trial with investigational treatment for prostate cancer within 30 days before starting olaparib.
interoception and eating behaviors in children

Conditions: Obesity, Childhood; Eating Behavior

Summary: the purpose of this study is to examine how individual differences in interoception (the ability to sense, interpret, and act on bodily feelings like hunger, fullness, thirst, hot, cold, etc.) relate to eating behaviors in children ages 7-10 years. findings will inform whether interventions targeting interoceptive awareness may be helpful for prevention of obesity and related chronic diseases.

the overall goal of this project is to examine if interoception (the process by which internal bodily states, like hunger and fullness, are sensed, integrated, interpreted, and regulated) is associated with bmi and obesity-related eating behaviors in children age 7-10 years. the specific aims are: aim 1: determine associations between interoception and non-homeostatic eating h1: multi-systems measures of interoceptive awareness (e.g., heartbeat perception, gastric interoception, self-reported interoceptive awareness) will be inversely associated with intake (kcal) in the eating in the absence of hunger (eah) task aim 2: assess salivary ghrelin and leptin as interoceptive signals of hunger/satiety h1: children with greater postprandial suppression of ghrelin will eat less in the eah task h2: children with greater postprandial suppression of ghrelin will have better interoceptive awareness h3: children with higher leptin will exhibit less sensitivity to changes in ghrelin aim 3 (exploratory): identify interoceptive phenotypes that may predict obesity risk using k-means cluster analysis, we aim to identify subgroups of individuals who exhibit different combinations of interoceptive variables. we will then examine differences in eating behavior and weight between clusters. participants will attend two study visits at the clinical research center at penn state university park campus. at the first visit, children will have their height, weight, and body composition measured, complete measures of interoception, and complete surveys/interview. parents will complete a survey. at the second visit, children will eat a meal, taste snacks, provide saliva samples, and play cognitive games on a tablet.

Eligibility criteria:
inclusion criteria: * child must be 7-10 years of age * participating parent must be at least 18 years of age, but there is no upper age limit * able to understand and answer questions in english exclusion criteria (all applicable to child only): * bmi for age \<5th percentile * monogenic obesity condition (e.g., prader willi syndrome) * autism/autism spectrum disorder * developmental delay * eating disorder * diabetes * heart condition * taking medications impacting appetite (e.g., stimulants, weight control medications) * any other condition significantly impacting growth, eating behavior, or cardiac function * allergy or dietary restriction to study foods * severe/untreated oral/dental health problems * orthodontic procedure or adjustment of braces within the past omonth * oral surgery or major oral/dental procedure within past month * had an x-ray within the past month

Keywords: interoception eating behavior ghrelin
marital functioning among combat veterans

Conditions: Stress Disorders, Post-Traumatic

Summary: the purpose of this research study is to examine marital dynamics related to husband-wife reunification following the veteran's return

we are interested in patterns of husband/wife communication and interaction regarding conflict resolution, trauma experiences, marital satisfaction, occupational functioning, social functioning, family functioning, and substance use. we hope to discover ways to assist couples in reducing marital stress.

Eligibility criteria:
inclusion criteria: * 18 and older * married or in a married like relationship * one partner has served in afghanistan or iraq exclusion criteria: * separated
cerebral oxygenation in total hip arthroplasty patients

Conditions: Cerebral Oxygen Desaturation; Post-operative Delirium

Summary: we plan to investigate the relationship between hypotensive epidural anesthesia for hip arthroplasty and cerebral oxygen saturation.

the relationship between cerebral oxygenation and blood pressure in patients undergoing hypotensive epidural anesthesia has not been completely elucidated. previous publications have demonstrated a low incidence of post-op cognitive dysfunction in patients undergoing hypotensive epidural anesthesia for total hip replacement (1-3) and that cerebral blood flow velocity is preserved as measured by transcranial doppler (4). an earlier investigation by dr. yadeau demonstrated infrequent cerebral oxygen desaturation in spontaneously breathing patients undergoing shoulder arthroscopy, even in the presence of hypotension (4), but did not investigate outcomes in the cognitive domain or have a control group of patients undergoing surgery with general anesthesia. there has only been one study looking at cerebral oxygenation and hip surgery, which was performed in elderly patients with fractures. it demonstrated that patients with low pre-op regional cerebral oxygen saturation (rso2) had higher incidence of delirium (5) but many of those patients had surgery under general anesthesia. given the costs associated with post-op delirium, cognitive dysfunction and stroke (6) and based on the fact that previous publications from this institution have demonstrated both a low incidence of cognitive dysfunction and preservation of cerebral blood flow velocity using this anesthetic technique, we hypothesized that cerebral oxygen desaturation will not occur in this population.

Eligibility criteria:
inclusion criteria: * patients 18-80 years old undergoing unilateral total hip arthroplasty * hypotensive epidural anesthesia exclusion criteria: * contraindication to controlled hypotension and/or neuraxial anesthesia. * severe pulmonary hypertension or pre-op systolic blood pressure reading \>150 mm hg * moderate to severe valvular stenosis. * history of stroke, dementia, or post-op delirium * prior osa diagnosis * history of benzodiazepine use (regular use for longer than 3 months) * chronic renal or hepatic disease (renal failure, history of liver failure, cirrhosis) * history of alcoholism or heavy alcohol intake (defined as averaging more than 3 drinks per night; recovery is ok) * parkinson's disease * severe chronic pulmonary disease * total anterior hip approach being used * hip resurfacing procedure * non-english speaking\* * questionnaires being used to assess mental status are only validated in english.
the qutenza patch as treatment for disabling treprostinil (remodulin) infusion site pain

Conditions: Pulmonary Hypertension; Pulmonary Arterial Hypertension

Summary: subcutaneous treprostinil (remodulin) is effective therapy for pulmonary arterial hypertension, a life threatening disease of the lung blood vessels. unfortunately, treprostinil is irritating to the skin and many patients experience intense pain at the infusion site for the first 7-10 days after placing a new subcutaneous infusion site. qutenza is an fda approved formulation of 8% capsaicin that is approved for the treatment of post-herpetic neuralgia, a painful skin condition. the investigators hypothesize that pretreatment of an area of skin with qutenza would decrease the pain associated with a new treprostinil infusion site. the investigators hope that qutenza will decrease both the intensity of the pain and the duration of the pain after patients place a new treprostinil infusion site. in this initial study, the investigators will provide qutenza in open-label, unblinded fashion and ask patients to rate their pain using a diary tool with which they are already comfortable.


Eligibility criteria:
inclusion criteria: * pulmonary hypertension * using subcutaneous treprostinil * already participating as a subject in our prospective study of infusion site pain * has documented debilitating pain (6/10 or greater) in the study after a site change exclusion criteria: * uncontrolled hypertension * recent stroke or myocardial infarction

Keywords: qutenza capsaicin remodulin treprostinil
r-5280 in newly diagnosed patients with type 1 diabetes

Conditions: Type 1 Diabetes; Type 1 Diabetes (Juvenile Onset); Diabetes Mellitus, Type 1

Summary: evaluating the adverse events and tolerance of r-5280 in mitigating type 1 diabetes in newly diagnosed patients

double blinded, placebo controlled, phase 1b study assessing the safety and efficacy of 12 weeks daily administrations of r-5280 in newly diagnosed type 1 diabetes adolescents

Eligibility criteria:
inclusion criteria: * newly diagnosed children (age 11-17 years old) * bmi \<85% * diagnosed by ada criteria with t1d within 2 years * accepted to adhere to a healthy diabetic diet as recommended by the ada exclusion criteria: * monogenic forms of diabetes or type 2 diabetes * history of ongoing infection or antibiotic treatment within the past four (4) weeks * history of immunocompromised, recurrent infections, steroid intake (inhaled or oral forms) or other immunosuppressant use in the past six (6) months * history of chronic gastrointestinal disease, possible or confirmed celiac disease * pregnancy or possible pregnancy * allergy to corn (prebiotic), milk allergy, soy (present in the mmtt meal) or their products * participation in other intervention research trials within the past three (3) months * anticipated major change in diabetes management during the study (e.g., change from injections to insulin pump therapy or new continuous monitor usage, all known to significantly alter glycemia) * children consuming a high-fiber or vegetarian diet (consuming three (3) or more servings of high fiber foods on four (4) or more days per week) or any fiber supplements will be excluded (to be assessed at screening) * any covid vaccines within 30 days prior to day 1

Keywords: type 1 diabetes
trial to evaluate the hemostatic effect of lyostypt® versus surgicel® in arterial bypass anastomosis

Conditions: Peripheral Vascular Diseases; Hemostasis

Summary: the purpose of this trial is to demonstrate that the bleeding time of suture holes after construction of arterial bypass anastomosis is shorter after treatment with lyostypt® than with surgicel®

hemostasis in peripheral vascular surgery is made more difficult by the need for direct arterial and arterial graft suturing as well as by systemic anticoagulation to prevent thrombosis during periods of vascular occlusion. polytetrafluorethylene (ptfe) is one of the most frequently used graft materials for vascular replacement or bypass in the case when no autologous venae are available (1). however, the insufficient elasticity of ptfe and its porosity promote the development of suture hole bleeding (2,3) which can cause considerable loss of blood and prolongation of operations (2). this study is designed to demonstrate the superiority of lyostypt® to oxidized cellulose (surgicel®) for hemostasis of suture hole bleeding in arterial bypass anastomoses after vascular reconstruction. lyostypt® is an absorbable, wet stable collagen compress made of collagen fibrils of bovine origin. collagen leads to thrombocyte adhesion and to activation of coagulation factor xii. therefore collagen is very effective in hemostasis. collagen is cell-friendly whereas other hemostats significantly disturb cell growth. advantages of collagen fleece are fast induction of hemostasis, low tissue reaction and fast absorption (15). furthermore, collagen was shown to be the best overall hemostatic agent in microvascular surgery. authors concluded that collagen fleece establish faster hemostasis than oxidized cellulose and that it was resorbed faster than oxidized cellulose (15).

Eligibility criteria:
inclusion criteria: * patients with an indication for a peripheral vascular reconstruction due to peripheral vascular disease (pvd) including femoro-femoral, femoro-popliteal and femoro-crural reconstructions or the need of a crossover including femoro-femoral or ilaco-femoro reconstruction. * suture hole bleeding of peripheral arterial bypass anastomosis using ptfe graft prosthesis * written informed consent exclusion criteria: * emergency surgery * patients with coagulopathy or uremia * reoperation within one month at the same location * pregnant and breastfeeding women * known or suspected allergies or hypersensitivity to any of the used devices (e.g. to material of bovine origin) * severe comorbidity (asa ≥ 4) * life expectancy less than 12 months * current immunosuppressive therapy (more than 40 mg of corticoid per day or ezathioprin) * chemotherapy within last 4 weeks * radiotherapy on the treated region within the last 2 months * severe psychiatric or neurologic diseases * lack of compliance

Keywords: ptfe graft suture hole bleeding hemostasis
genetic association of glucocorticoid receptor gene polymorphisms with binge eating

Conditions: Binge-Eating Disorder; Eating Disorders; Obesity; Diabetes Type 2; Adolescent Behavior

Summary: the aim of the present study was to specifically screen obese diabetic adolescent female individuals for bed, checking the variants of the gr gene (rs56149945; rs41423247) amongst identified individuals, and this led to assessing the impact of binge eating disorders on glycaemic control in obese diabetic adolescent females in pakistan, south asia.

challenges in eating for diabetic adolescents can be categorized as eating disorders (ed) and disordered eating symptoms (des). binge-eating disorder (bed) is defined as recurrent episodes of binge eating at least once a week over a three-month time period and it is accompanied by feeling the lack of control and marked distress over one's eating behaviour. the aim of the present study was to specifically screen obese diabetic adolescent female individuals for bed, checking the variants of the gr gene (rs56149945; rs41423247) amongst identified individuals, and this led to assessing the impact of binge eating disorders on glycaemic control in obese diabetic adolescent females in pakistan, south asia.

Eligibility criteria:
inclusion criteria: * unmarried females diagnosed with type 2 diabetes \> 12 months * age 10-19 years * obesity class i and ii (based on bmi range of 30 - 40). exclusion criteria: * presence of psychosis, major psychiatric or neurocognitive disorder * substance use * untreated attention-deficit hyperactivity disorder * use of psychopharmacological medications or psychotherapy * class iii obesity
severe alcohol-use disorder: a tdcs and response inhibition training intervention

Conditions: Alcohol Use Disorder

Summary: most severe forms of alcohol-use disorder are thought to reflect an abnormal interplay between two neural systems: an overly active impulsive one driven by immediate rewards prospects and a weak reflective one, tuned on long-term prospects. the investigators propose that two non-pharmacological interventions, transcranial direct current stimulation (tdcs) and inhibitory control techniques (ict) may act on both systems when combined, which might ultimately result is a reduction of alcohol relapse rate.

treating alcohol dependence remains notoriously difficult despite use of several medications, psychotherapeutic and psychosocial interventions. alcohol dependence is thought to reflect an abnormal interplay between two neural systems: an overly active impulsive one driven by immediate rewards prospects and a weak reflective one, tuned on long-term prospects. the investigators proposes that two non-pharmacological interventions, transcranial direct current stimulation (tdcs) and inhibitory control techniques (ict) may act on both systems when combined. tdcs has been found to improve working memory, which is necessary to evaluate long-term consequences of actions. ict is able to modify the automatic approach tendencies towards appetitive cues. the investigators will recruit 160 alcohol-dependent patients and divide them randomly between four treatment conditions : real transcranial direct current stimulation (tdcs) with active or control inhibitory control technique (ict ); or sham (placebo) tdcs with active or control ict. patients will be evaluated with primary outcome measures (alcohol consumption patterns) and secondary outcome measures (working memory and changes in alcohol-related stimuli affective values).

Eligibility criteria:
inclusion criteria: * patients with severe alcohol-use disorder (dsm-5 criteria), hospitalized for detoxification. * severity of alcohol use disorder must be at least moderate (at least 4 dsm-5 criteria) * aged between 18 and 65 years * comorbidity with anxiety disorders and depressive disorders is allowed * patients must be illegal drug free for 3 weeks at beginning of trial * pharmacotherapy: patients should be benzodiazepines free at the moment of inclusion. they are allowed to continue other psychotropic medication (antidepressants, antipsychotics, mood stabilizers), providing they are following a stable regimen that will not be changed during the protocol time. * patients must be reachable for follow-up exclusion criteria: * previous neurological conditions (epilepsy, traumatic brain injury, stroke) * present delirium, confusion or severe cognitive disorder * schizophrenia, chronic psychotic disorders, bipolar type 1 disorder. * any severe, life-threatening disorders * high suicidal risk * specific contraindications for tdcs: metallic plates in the head * alcohol medication treatment initiated during the rehab: acamprosate, disulfiram, baclofen, nalmefen.

Keywords: alcohol tdcs inhibition cognitive training implicit cognition relapse craving
microrna expression in renal cell carcinoma

Conditions: Carcinoma, Renal Cell

Summary: in this study, renal cell carcinoma (rcc) related mirna and the target genes of related mirna will be examined in order to investigate the role of mirna in the formation of rcc and look for the biomarker of rcc.

due to the lack of specific indicators for the early diagnosis of rcc, the rcc patients often have distant metastasis when diagnosed and their five-year survival rate is much low. therefore, the biological markers of rcc are needed for early detection, early treatment and improvement of the survival rate of rcc patients. mirna and tumor are closely related. mirna can control the important cancer-related genes and participate in the tumor cell proliferation, apoptosis, invasion and angiogenesis. in this study, rcc related mirna and the target genes of related mirna will be examined,and the relationship between rcc related mirna and the rcc pathological types, tnm (tumor-nodes-metastasis) stages and prognosis will be analyzed. the purpose of this study is to investigate the role of mirna in the formation of rcc and look for the biomarker of rcc.

Eligibility criteria:
inclusion criteria: * patients with primary renal cell carcinoma. * subjects who agree to participate in the study and sign the informed consent. exclusion criteria: * patients with secondary renal cell carcinoma. * subjects who refuse to participate in the study and sign the informed consent.

Keywords: carcinoma, renal cell micrornas