Kornimate/medical-research-clean huggingface dataset:
to assess the patient preference for goserelin microsphere versus goserelin implant in patients with prostate cancer

Conditions: Prostate Cancer

Summary: the gomimp will be a prospective, randomized, cross-over trial to explore the patient preference for goserelin microsphere (zoladex®) versus goserelin implant (ly01005) in patients of prostate cancer

androgen deprivation therapy (adt) is an important systemic therapy for prostate cancer, which plays a vital role in the treatment of various stages of prostate cancer. gonadotropin-releasing hormone (gnrh) agonists are the most commonly used adt treatment，including leuprolide, goserelin, and triptorelin. the goserelin implant (zoladex®) 3.6 mg is administered subcutaneously every 28 days into the anterior abdominal wall using a pre-filled syringe with a 16g needle (outer diameter 1.6 mm), while the goserelin microsphere (ly01005) 3.6 mg is administered every 28 days by intramuscular injection using a 21g injection needle (outer diameter 0.8 mm). phase iii study (nct04563936) have confirmed the similar efficacy and safety between the two drugs, but patient preference for both are unknown. the objective of this study was to explore the patient preference for goserelin microsphere versus goserelin implant in patients of prostate cancer.

Eligibility criteria:
inclusion criteria: 1. male patients older than 18 years 2. histologically confirmed prostate adenocarcinoma 3. suitable for adt treatment 4. ecog≤2 5. prior treatment without gnrh agonists 6. expected survival \>1 year 7. good compliance 8. adequate organ or bone marrow function as evidenced by: * hemoglobin \>/= 10 g/dl * absolute neutrophil count \>/=1.5 x 109/l, * platelet count \>/=100 x 109/l, * ast/sgot and/or alt/sgpt \</=1.5 x uln; * total bilirubin \</=1.5 x uln, * serum creatinine \</=1.5 x uln. if creatinine 1.0 - 1.5 xuln, creatinine clearance will be calculated according to ckd-epi formula and patients with creatinine clearance \<60 ml/min should be excluded exclusion criteria: 1. prior treatment with zoladex, ly01005 or other gnrh agonists, while gnrh agonists for \< 6 months and discontinued for more than 6 months were allowed 2. diagnosed or suspected hormone-resistant prostate cancer, hypophysectomy, adrenalectomy, or pituitary lesions 3. a history of cardiovascular events, uncontrolled hypertension, gastrointestinal disease that interferes with treatment absorption, active viral hepatitis, or human immunodeficiency infection (hiv) within the past 6 months 4. any medical conditions that the investigators believe make the patient ineligible to participate in the study
clinical study of the hyperviscosity syndrome in waldenström macroglobulinemia

Conditions: Hyperviscosity Syndrome; Waldenstrom Macroglobulinemia

Summary: walsdenström macroglobulinemia (wm) is defined by a bone marrow lymphoplasmacytic infiltration and the presence of a monoclonal immunoglobulin m (igm) in blood. clinical manifestations of the hyperviscosity syndrome (hvs) are related to the large amount of igm in circulating blood or to some physicochemical characteristics such as the presence of a cryoglobulin property. although hvs is one of the most frequent criteria for initiating therapy in wm, few studies focused on its description and no diagnostic criteria are available. the present study aims to identify a diagnostic system for hvs, taking into account objective symptoms such as bleedings, fundoscopic findings and also subjective symptoms such as fatigue and comorbidities that may influence the severity of symptoms.


Eligibility criteria:
inclusion criteria: * patient with wm * patients that may require a first-line or subsequent-line therapy * patients who will require treatment initiation * patients with serum monoclonal component concentration greater than 15 g/l and who will underwent hyperviscosity assessment, even if hyperviscosity is not found and in the absence of other treatment criteria, no treatment is finally initiated. * patients agreeing to give informed consent. exclusion criteria: * patients with another chronic b-cell malignancy * patients with lymphoplasmacytic proliferations * patients with marginal zone lymphoma. * patients with wm and histologic transformation * absence of informed consent.

Keywords: hyperviscosity syndrome waldenstrom macroglobulinemia
asthma and atopic dermatitis validation of promis pediatric instruments

Conditions: Atopic Dermatitis; Ichthyosis; Psoriasis

Summary: this is designated to validate patient-reported outcomes (pro) measures in itch-specific pediatric skin conditions, such as atopic dermatitis, and examine the ability of a modified stigma instrument to assess the severity and type of stigma experienced in atopic dermatitis and other potentially stigmatizing conditions.

this study involves a series of research and development projects targeted at two of the most common chronic diseases affecting children: asthma and atopic dermatitis (ad, or eczema). the investigators propose to directly validate patient-reported outcomes (pro) measures in a large cohort of itch-specific pediatric skin conditions, with a primary focus on ad. the investigators propose to examine the ability of promis (patient-reported outcomes measurement information systems) instruments to detect meaningful and clinically significant change in disease status, as well as to create a pediatric itch item pool and pro model for signs and symptoms of skin disease. the investigators will also examine the ability of a modified neuro-qol stigma instrument to assess the severity and type of stigma experienced in ad and across various dermatologic or other potentially stigmatizing conditions. lurie children's hospital will only be involved in the ad and stigma portions of this project

Eligibility criteria:
inclusion criteria: * affected children must have moderate to severe ad or another skin condition that causes itch, experience itch, understand english, and be able to complete an english-based survey * any child with a potentially disfiguring skin condition or change in appearance related to disease/intervention will be considered eligible. parents of children with such conditions will also be asked to participate. children and parents must also understand english and be able to complete an english-based survey sub-study inclusion criteria: 1. patients ages 8 years-17 years with a diagnosis of mild ad 2. patients ages 6 months to 8 years with a diagnosis of ad (any severity) 3. english speaking 4. families must be able to access the internet (e.g., skype or facetime) for follow-up, or be able to come for follow-up within five days of an ad flare and again when improved. 5. patients with developmental delay and/or a behavioral disorder that would preclude participation in form completion will not be eligible for this study.
improving functions in mtbi patients with headache by rtms

Conditions: TBI (Traumatic Brain Injury)

Summary: due to recent wars in afghanistan and iraq, the number of veteran suffering from mild traumatic brain(mtbi) injury and ptsd increases rapidly. headache is one of the most debilitating clinical symptoms in veteran with mtbi and the cause of it is still not entirely clear. recently, the use of non-invasive brain stimulation such as repetitive transcranial magnetic stimulation(rtms) has yielded favorable clinical outcome in a few intractable chronic central pain conditions including headaches. this study aims to 1) assess the effect of rtms in relieving headache and improving neurophysiological functions; and 2)explore the neuronal mechanisms associated with mtbi related headache and the analgesic effect of rtms with function magnetic resonance imaging (fmri).

this study will only be conducted at the veterans affair hospital in san diego.

Eligibility criteria:
inclusion criteria: * male or female age between 18 to 50 * history of mtbi based on the clinical diagnostic criteria * history of headache more than 3 months * no prior experience of tms treatment * pre-treatment headache intensity m-vas 30(0-100 scale) and average daily headache nps 3(0-10 scale) * at least one headache exacerbation per day * a normal brain mri in the past 3 months exclusion criteria: * pregnancy * history of pacemaker implant * any ferromagnetic(e.g. bullet fragment, shrapnel, device implant) in the brain or body that will prohibit the patients from having a brain mri * history of dementia, major psychiatric diseases, or life threatening diseases * presence of any other chronic neuropathic pain states * history of seizure * pending litigation * lack of ability to understand the experimental protocol and to adequately communicate in english * history of chronic headache prior to the incidence of mtbi
psychoeducation of adult siblings of asd people (autism spectrum disorder).

Conditions: Autism Spectrum Disorder; Sibling Relations

Summary: the aim of this study is to apply a psychoeducational program in adult siblings of people with asd as a means to provide knowledge related to the disorder and improving their quality of life. the psycho-educational program will be implemented in adult siblings of people with asd and its effectiveness will be assessed. participation in this program is expected to contribute in the improvement of the quality of life of the participants, their siblings with asd and those related to them. no risk is identified.

autism spectrum disorder (asd) is a neurodevelopmental lifelong disorder of which prevalence has been significantly increased through the decades. notwithstanding the abundant research finding on the asd people and their parents regarding their mental health, quality of life etc., limited evidence exists regarding the siblings of people with asd. the aim of this study is to apply a psychoeducational program for asd in adult siblings of people with asd as a means of providing disorder - related knowledge and improving their quality of life. the psychoeducational program will provide basic knowledge about asd, training on behavioral management, acceptance and ongoing support to serve the needs of people with asd and their caregivers. this study will be a randomized controlled trial (rct) with voluntary participation. the psycho-educational program will be implemented in adult siblings of people with asd, free of charge, it will be conducted online by certified trainers, due to the coronavirus pandemic and its effectiveness will be assessed. the sample will be recruited from the general population of greece. four groups, each divided into experimental groups and control groups, will be randomized. to evaluate the effectiveness of the program, participants will be asked to complete the online questionnaires three times (before the psychoeducation, after completion and three months later). participation in this program is expected to contribute in the improvement of the quality of life of the participants, their siblings with asd and those related to them. no risk is identified. this study is part of a doctoral thesis in progress at the hellenic mediterranean university (helmepa), department of social work. the study is expected to start in april 2024 and to be completed about six months later.

Eligibility criteria:
inclusion criteria: * adults * have a brother or a sister diagnosed with asd exclusion criteria: * underage * no sibling with asd * have two or more siblings with asd * have already been trained to "cygnet" psychoeducational program.

Keywords: psychoeducation siblings siblings relationship asd autism spectrum disorder
determination of biological activity of enriched serum following totum-448 consumption

Conditions: NAFLD; MASLD; Mild Inflammatory Context

Summary: dietary intakes of saturated fatty acids remain well above nutritional recommendations for most european countries. this may progressively lead to a pro-inflammatory context and the alteration of lipid metabolism in the liver. the hypothesis of this study is that totum-448 promotes the normal function of hepatocytes in a mild inflammatory context. to determine the cellular and molecular effects of totum-448, circulating bioactive molecules after totum-448 intake will be collected and then studied in human hepatocytes using an innovative ex vivo clinical approach developed by clinic'n'cell.


Eligibility criteria:
main inclusion criteria: * lipid profile within reference values * glycemia \< 100mg/dl * normal hepatic function * normal blood formulation * normal renal function * bmi between 20 and 28kg/m2 * non smoker or occasional smoker main exclusion criteria: * all types of vaccination within one month * alcohol intakes superior to world health organization recommendations * ongoing pharmacological, dietary supplement and/or probiotic treatment * consumption of enriched functional foods or dietary supplements within two weeks of inclusion * any known disease * allergy to ingredients of the study product * with dietary habits incompatible with the study conduct

Keywords: ex vivo lipid metabolism inflammation hepatocytes oxidative stress plant extract polyphenols dietary/food supplement
high dose intravenous ascorbic acid in severe sepsis

Conditions: Sepsis

Summary: despite an organized treatment approach outlined in expert-consensus guidelines for sepsis with fluid resuscitation to treat hypovolemia, antibiotics to target the infectious insult, and vasopressors for hypotension, mortality rates for sepsis remain high and the incidence continues to rise, making sepsis the most expensive inpatient disease. 1. recent research has described the therapeutic benefits associated with ascorbic acid treatment for sepsis. 2. researchers objectives are to perform a randomized-controlled clinical trial investigating the ability of ascorbic acid(vitamin c) administration to decrease organ dysfunction in severe sepsis. the widespread occurrence of microvascular dysfunction in sepsis leading to tissue hypoxia, mitochondrial dysfunction, and adenosine triphosphate (atp) depletion, gives rise to organ failure. 3. patients with organ failure and sepsis (severe sepsis) are at a higher risk of death than patients with organ failure alone. critically ill patients may have an increased requirement for ascorbic acid in sepsis and these patients frequently have levels below normal. ascorbic acid administration, has been shown to correlate inversely with organ failure (human literature) and directly with survival (animal studies). 4,5 intravenous ascorbic acid therapy decreases organ failure by providing a protective effect on several microvascular functions including improving capillary blood flow, decreasing microvascular permeability, and improving arteriolar responsiveness to vasoconstrictors. defining the utility of novel agents to augment researchers care for severe sepsis is an important task as investigators continue the institutional focus on sepsis care.


Eligibility criteria:
inclusion criteria: patients with: 1. a suspected or confirmed infection with an order for intravenous antibiotics or antivirals 2. the presence of acute sepsis-induced organ dysfunction definition of organ dysfunction: 1. arterial hypoxemia \[pao2 /fio2 \< 300\] 2. hypotension \[systolic blood pressure (sbp) \ 40 mmhg\] 3. lactic acidosis \[lactate \> 2.5 mmol/l\] 4. acute kidney injury \[creatinine \>2.0 or urine output \ 2 hours despite fluid resuscitation\] 5. thrombocytopenia \[platelet count \< 100,000\] 6. acute coagulopathy \[international normalized ratio (inr) \> 1.5\] 7. hepatic failure \[bilirubin \> 2 mg/dl\]. 8. predisposition, infection, response, and organ failure (piro) score ≥ 10 exclusion criteria: 1. age \< 18 years 2. pregnancy or breastfeeding 3. requirement for immediate surgery within the treatment protocol timeframe 4. inability to obtain written informed consent from subject or surrogate 5. patient to receive comfort measures only
mobilization protocol for knee arthroplasty patients

Conditions: Pain; Anxiety; Physical Function; Mobility; Arthroplasty

Summary: this randomized controlled study evaluates the effect of mobilization protocol applied to knee arthroplasty patients on anxiety level, pain, mobility and functional status.

in the study, 68 knee arthroplasty patients were randomly assigned to the study and control groups. the mobilization protocol was applied to the study group (34). the mobilization protocol starts on the day of the operation and is completed on the day of discharge. the patient is mobilized within the first 24 hours after surgery. mobilization protocol includes six levels. level 1: repositioning should occur every two hours. level 2: range of motion (prom) should occur at least three times a day. level 3: the head of bed (hob) \>30 degrees. duration goal: 5-15 minutes. hob 65≥ degrees with patient sit in the bed. duration goal: 5-15 minutes. progress to level 4. level 4: hob 65≥ degrees with legs in dependent position (recliner chair). duration goal: 5-15 minutes. progress to level 5. level 5: stand/pivot/step to chair. sitting in chair. duration goal: 5-15 minutes. progress to level 6. level 6: patient is able to ambulate at least three times a day. no intervention was applied to the control group. the primary outcome of the study is the effect of mobilization protocol on the state anxiety level, pain, mobility and physical function of knee arthroplasty patients. the results collected before the mobilization protocol, postoperative first day, second day, the discharged day and the 3rd week after discharge.

Eligibility criteria:
inclusion criteria: volunteering to participate in research being 18 years or older having unilateral elective knee arthroplasty surgery having da surgery for the first time it is the absence of an obstacle to communicating cognitively, emotionally and verbally. exclusion criteria: patients who initially agreed to participate in the study but wished to leave later were excluded from the study. in the event of a complication affecting the mobilization of the patient during the intraoperative and post-operative period, the patient is excluded from the study. he was excluded from the study due to the development of a cognitive, emotional and verbal barrier to communication after the surgery.

Keywords: knee arthroplasty nursing mobilization protocol patient outcome nurse sensitive outcomes orthopaedic and trauma nursing
use of antagonist versus agonist gnrh in oocyte recipient endometrium preparation

Conditions: Infertility

Summary: oocyte donation is a well established procedure in assisted reproduction treatments (art). it is demonstrated that the use of hormonal substitution therapy, for the synchronization of the cycles between the recipients and the donors, provides good results, similar to the ones obtained with the natural cycle. in the patients - recipients with preserved ovarian function, the recipient's natural cycle is annulled, thus preventing the spontaneous luteinizing hormone surge. simultaneously and while waiting for the suitable donor, her endometrium is prepared. when the donation occurs and fertilization with the husband sperm takes place, her cycle is stimulated again in order to synchronize her window of implantation with the donor's ovulation. two different medications are commonly used to inhibit spontaneous ovulation: either gnrha agonist or gnrh antagonists. the present study consists of the comparison between the single dose gnrh agonist (decapeptyl 3,75 im) and the 7 day dosage of gnrh antagonist (cetrotide 0,25 mg). the administration of gnrha is used fundamentally as a long liberation formulation, administered in a single intramuscular injection (im), which is more practical in terms of use. nevertheless, the unnecessary persistence and the potentially unfavorable action of gnrha during the luteal phase and early gestation have questioned its use. the recovery of the hypophysarian function begins only 8 weeks after the single injection of long liberation of triptorelina 3.75 mg. the gnrh antagonist (cetrotide 0,25 mg) makes the hypofisary inhibition shorter than with the analogues and can prepare similar endometrium characteristics as a natural cycle. the recipients will be assigned randomly to a group of treatment or another.


Eligibility criteria:
inclusion criteria: * infertile females with preserved gonadal function * ages 18 - 43 years old exclusion criteria: * bmi: \> 28 * recurrent miscarriages * severe male factor * important miomas * \> 44 years old

Keywords: oocyte donation endometrial preparation
gdf15 in anorexia nervosa

Conditions: Anorexia Nervosa

Summary: evaluating plasma levels of a protein called gdf15 in active and recovered anorexia nervosa, as well as healthy controls


Eligibility criteria:
inclusion criteria: - active dsmv diagnosis of anorexia nervosa/ at least two years of recovery from dsmv anorexia nervosa / no history of anorexia nervosa exclusion criteria: - male
phase i clinical trial to evaluate the safety, tolerability and pharmacokinetics of yhb1411-2 in healthy male volunteers

Conditions: Rheumatic Arthritis

Summary: a block-randomized, double-blind, placebo-controlled, single-dose escalating, phase i clinical trial to evaluate the safety, tolerability and pharmacokinetics of yhb1411-2 in healthy male volunteers

first in human study

Eligibility criteria:
inclusion criteria: 1. healthy male volunteers of aged between 20 to 45 years old at the time of screening 2. volunteers weighing over 50 kg with body mass index between 18.0 \~ 28.0 kg/m2 3. volunteers who has signed a written informed consent voluntarily, prior to any procedure, using a form that is approved by the local institutional review board after detail explanation of the purpose, contents, and characteristic of the drug exclusion criteria: 1. have history or presence of clinically significant diseases in liver, kidney, gastrointestinal tract, nervous system, respiratory system, endocrine system, blood•tumor, cardiovascular, urinary system, and mental disorder 2. presence of current tuberculosis or latent tuberculosis or have history of tuberculosis (confirmed by chest x-ray test or tuberculin skin test) 3. have active infection such as chronic or topical infection 4. have history of hospitalization or have received antibiotics due to serious infection within 1 month prior to the first administration 5. have know hypersensitivity to biologicals 6. have ast(sgot) or/and alt(sgpt) \> 1.5 times of normal upper limit at the time of screening 7. shown positive results in any of hbsag, hcv ab, hiv ab tests 8. have history of drug abuse or shown positive reaction of drug abuse in urine test at the time of screening 9. received any biological drugs including monoclonal antibody products or protein drugs within the last 6 months prior to the first administration 10. participated in any other clinical trials within 2 months prior to the first administration of investigational product 11. have donated whole blood within 2 months prior to the first administration of investigational product, or donated blood components or received transfusion within 1 month prior to the first administration of investigational product 12. subject who drink continuously (over 21 units/week, 1 unit = 10 g of pure alcohol) or who cannot quit drinking while hospitalized 13. smoker (subject can be enrolled if he/she had quit smoking within 3 months before the first administration of investigational product (day 1)) 14. subject who is judged to be ineligible by principal investigator or sub-investigator according to various reasons including their abnormal test results (clinical laboratory test, chest x-ray test, 12-lead ecg)