Kornimate/medical-research-clean huggingface dataset:
comparison of traditional dysphagia therapy and developed protocol for dysphagia patients in intensive care unit

Conditions: Dysphagia

Summary: dysphagia (swallowing disorders) in intensive care unit (icu) patients is associated with poor outcomes, including aspiration pneumonia, prolonged hospitalization, and increased mortality. traditional dysphagia management approaches may be insufficient for the unique needs of critically ill patients. this study aims to evaluate the effectiveness of a newly developed icu-specific dysphagia protocol compared to traditional therapy approaches.

the aim of this study are: 1. to compare the efficacy of traditional dysphagia therapy versus a developed icu-specific protocol in improving swallowing function 2. to assess the impact of both approaches on clinical outcomes including aspiration rates, time to oral intake, icu length of stay, and pneumonia incidence 3. to identify patient subgroups that may benefit most from the specialized protocol methods study design * prospective randomized controlled trial * single-center study in a tertiary hospital icu * 1:1 randomization to intervention or control group participants * total sample size: 90 adult icu patients (45 per group) * inclusion criteria: adult patients (≥18 years) admitted to icu with confirmed dysphagia by bedside evaluation within 72 hours of admission * exclusion criteria: preexisting neurological disorders affecting swallowing, head and neck cancer, inability to follow commands, expected icu stay \<48 hours this study will provide evidence for the efficacy of a specialized dysphagia management protocol tailored to the unique needs of critically ill patients. if proven effective, the protocol could establish new standards of care for dysphagia management in icu settings, potentially improving patient outcomes and reducing healthcare costs associated with dysphagia-related complications.

Eligibility criteria:
inclusion criteria: * adult patients (≥18 years) admitted to icu with confirmed dysphagia by bedside evaluation within 72 hours of admission * gcs more then 8 exclusion criteria: * preexisting neurological disorders affecting swallowing, head and neck cancer, inability to follow commands, expected icu stay \<48 hours

Keywords: dysphagia icu management protocol
evaluation of pet 18f-fludarabine for the initial assessment and end-treatment of symptomatic multiple myeloma patients

Conditions: Myeloma

Summary: the objective of this exploratory study is to evaluate, for the first time, the sensitivity of 18f-fludarabine to the initial diagnosis of mm compared to fdg-pet and mri. the interest of this molecule will also be investigated as part of the end-of-treatment therapeutic evaluation.


Eligibility criteria:
inclusion criteria: * symptomatic mm in the first line in patients who are not candidates for autologous bone marrow transplantation. * patients eligible for one of the treatments considered as standard in a patient who is not eligible for autograft, according to esmo's european recommendations * mm with measurable disease either by the serum evaluation of the monoclonal component or by the determination of free light chains (serum or urinary). * patient affiliated with a social insurance scheme * the patient must understand and voluntarily sign the informed consent form * women of childbearing potential must have a serum pregnancy test (performed within 2 days before each pet scan.) * women of childbearing potential must use an effective contraceptive method throughout the course of the study and for 30 days after the last pet. * male patients (vasectomised or not) with a pregnant partner or a partner of childbearing potential must use a condom and a spermicide until 90 days after the last pet. * hiv serology known to be negative * karnofsky ≥ 70 or ecog 0-1 exclusion criteria: * age under 18 years * pregnancy or breastfeeding * male or female refusing birth control conditions * primary al amyloidosis and myeloma complicated by amyloidosis * neutropenia \<1000 pn / mm3 * thrombocytopenia \<70,000 / mm3 * hepatic impairment: bilirubin\> 35μmol / l and sgot, sgpt, alkaline phosphatase greater than 3 n * renal impairment defined by creatinine clearance \<50 ml / min * history of other malignancies with the exception of basal cell carcinoma and stage i cervical cancer * severe active infection * active infection with known hepatitis b or c virus. * patient with insulin-dependent or non-insulin-dependent diabetes mellitus. * intolerance or known allergy to any of the study drugs or any of its analogues * psychiatric illness that may interfere with participation in the study * patient under safeguard of justice * intellectual inability to sign informed consent * persons protected by law
latent tgf-β-binding proteins affect the fibrotic process in renal impairment and cardiac dysfunction

Conditions: Acute Coronary Syndrome; Acute Coronary Syndrome With Renal Dysfunction

Summary: the project is planed to explore the impact of ltbp4 and other matrix protein and potentially related biomarkers on renal outcomes, cardiac outcomes and all-cause mortality in patients with suspected acute coronary syndrome (acs).

the investigators will collect the blood samples from patients with suspect acs. ltbp4 will be the first matrix protein that are going to understand. upon hospital arrival, blood samples around 8 ml will be collected and the 2nd collection will be two weeks to one month after the event. the third collection will be one year later. in the between, if any acs event develop, blood samples will be collected as protocols.

Eligibility criteria:
inclusion criteria: - acute coronary syndrome patients exclusion criteria: - cardiogenic shock, pregnancy, end-stage renal disease
mohs surgery combind with cryotherapy for eyelid malignant tumors.

Conditions: Eyelid Tumor

Summary: this study aim to investigate whether the prognosis of eyelid malignant tumor is better treated with mohs surgery combind with cryotherapy than mohs surgery only.

this study is a randomized perspective study. american joint committee on cancer was applied to define the cancer stage of patients recruited. patients with tis to t3cn0m0 will be randomized to receive mohs surgery or mohs suregery conbind cryotherapy. patients will be followed for 3 years.

Eligibility criteria:
inclusion criteria: * ability to provide written informed consent and comply with study assessments for the full duration of this study. * definite pathology signs of eyelid basal cell carcinoma, squamous cell carcinoma and sebacous carcinoma, stage tis to t3cn0m0 based on american joint committee on cancer. * pathological examination showed the primary tumor was compeletely resected exclusion criteria: * any previous treatment in the study eye * tumor complicated with infection * any other tumors of the paticipants * intolerate of surgery or anesthesia

Keywords: eyelid tumor basal cell carcinoma squamous cell carcinoma sebaceous carcinoma mohs surgery cryotherapy
changes following inpatient child-oriented family treatment

Conditions: Psychiatric Disorders

Summary: children receiving ift (intensive family therapy) were assessed for symptom profile and global functioning before admission, 3 months after discharge and 1 year after discharge. children were assessed by parents, children, their teachers and themselves. parents were assessed by themselves at the same points in time through psychological self-report questionnaires. the study is intended to explore covariates to change in children as well as in parents during (pre-treatment) the treatment and follow-up periods.

ift is an intensive combinatory family treatment which is child-oriented, and traditionally used in an inpatient family treatment unit in child and adolescent psychiatry. measures include ones on bonding (pbi), personality traits (neo-pi), anxiety and depressive symptoms (hads), attributional tendencies (pat) and social desirable responding (bidr). a subgroup was also assessed before a waiting period (pre-treatment).

Eligibility criteria:
inclusion criteria: * family offered inpatient family treatment in child and adolescent psychiatry. exclusion criteria * inpatient treatment terminated prematurely

Keywords: severe and longstanding psychiatric symptoms in children
study of cabozantinib (xl184) versus prednisone in men with metastatic castration-resistant prostate cancer previously treated with docetaxel and abiraterone or mdv3100

Conditions: Prostate Cancer; Castration Resistant Prostate Cancer; Pain; Prostatic Neoplasms

Summary: this study will evaluate the effect of cabozantinib compared to prednisone on overall survival in men with previously treated metastatic castration-resistant prostate cancer with bone-dominant disease who have experienced disease progression on docetaxel-containing chemotherapy and abiraterone or mdv3100.


Eligibility criteria:
inclusion criteria: * histological or cytological diagnosis of castration resistant prostate cancer (serum testosterone less than 50 ng/dl). * evidence of bone metastasis related to prostate cancer on bone scans. * received prior docetaxel (minimum cumulative dose of 225 mg/m2) and either abiraterone or mdv3100 treatment and has evidence of prostate cancer progression on each agent independently. * maintenance of lhrh agonist or antagonist unless treated with orchiectomy. * recovered from toxicities related to any prior treatments, unless the toxicities are clinically non significant or easily manageable. * adequate organ and marrow function. * capable of understanding and complying with the protocol requirements and signed the informed consent form. * sexually active fertile patients and their partners must agree to use medically accepted methods of contraception (eg, barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 4 months after the last dose of study treatment. exclusion criteria: * prior treatment with cabozantinib. * treatment with docetaxel, abiraterone, or mdv3100 in the last 2 weeks; or with any other type of cytotoxic or investigational anticancer agent in the last 2 weeks. * radiation within 4 weeks (excluded if to mediastinum) or radionuclide treatment within 6 weeks of randomization. * known brain metastases or cranial epidural disease. * requires concomitant treatment, in therapeutic doses, with anticoagulants. * requires chronic concomitant treatment of strong cyp3a4 inducers (eg, dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, and st. john's wort). * uncontrolled, significant intercurrent illness including, but not limited to, cardiovascular disorders, gastrointestinal disorders, active infections, non-healing wounds, recent surgery. * clinically significant hematemesis or hemoptysis, or other signs indicative of pulmonary hemorrhage in the last 3 months, or history of other significant bleeding in the past 6 months. * cavitating pulmonary lesion(s) or a lesion invading or encasing a major blood vessel. * qtcf \> 500 ms within 7 days of randomization. * unable to swallow capsules or tablets. * previously-identified allergy or hypersensitivity to components of the study treatment formulations. * another diagnosis of malignancy requiring systemic treatment within 2 years of randomization.

Keywords: prostate cancer castration resistant prostate cancer bone pain crpc
bone marrow as an alternative site for islet transplantation

Conditions: Type 1 Diabetes; Postpancreatectomy Hyperglycemia

Summary: the goal of this study is to evaluate safety and feasibility of bone marrow (bm) as site for islet transplantation (tx) in humans. the investigators hypothesis is that bm represents a better site than liver thanks to its potential capacity to favor islet engraftment in face of a more easiness of access and bioptic follow up.

we were permitted to perform single intra bm islet infusion at the level of the iliac crest in patients having contraindications for intraportal infusion. a needle for bm aspiration (14 g) is inserted into the superior-posterior iliac crest and islet suspension (1:2.5; tissue:ringer's lactate solution) is infused. the entire intrabm-injection procedure lasted 8-15 min from the beginning of anaesthesia (short propofol sedation).

Eligibility criteria:
inclusion criteria: * diabetic patients eligible for pancreatic islet transplantation based on local accepted practice and guidelines. this includes at least: a)clinical history compatible with t1d with insulin-dependence for \>5 years; b) undetectable stimulated (arginine or mmtt) c-peptide levels (\<0.3 ng/ml) in the 12 months before transplant c)presence of severe hypoglycaemic events * patients undergoing total pancreatectomy because of anastomosis leakage after pancreatoduodenectomy or because of pancreatic anastomosis is made impracticable by technical difficulties and/or high risk of leakage. * presence of contraindications for intraportal islet infusion exclusion criteria: * presence of hematologic disease

Keywords: type 1 diabetes islet transplantation autotransplantation
efficacy of tazarotene in treatment of verruca plana

Conditions: Warts Flat

Summary: verruca plana is a common skin infection with worldwide distribution. approximately 10% of general population is infected with flat warts and it represents up to 18 % of the patients seeking treatment for warts. verruca plana is not merely an infectious disease but also affects the quality of patients' life. verruca plana causes major cosmetic and social concerns. lesions' persistence and recurrence cause frustrations and psychological distress which motivate patients to seek different treatment strategies. verruca plana commonly affects the school aged children which augments its effect on the psychological and social development of children with stigmatization and bullying are great risks. the available treatment strategies neither ensured complete clearance of the disease nor were free of side effects. frequently used physical removal methods are operator dependent and commonly lead to irritation, local inflammation, scars, dyspigmentation, and disfigurement. in this study we evaluate the efficacy and the safety of tazarotene gel 0.1% in the treatment of verruca plana compared to imiquimod or 5-fluorouracil

patients will be assigned randomly into one of 4 groups as 1:1:1:1 using randomization.com with the seed number 7607 * group (a): patients will be treated with topical tazarotene gel 0.1%with a cotton tipped applicator on every lesion once daily at night. * group (b): patients will be treated with topical 5- fluorouracil 5% cream applied once daily at night. * group (c): patients will be treated with imiquimod cream 5% applied once daily at night. * group (d): patients will be treated with petroleum jelly once daily at night.

Eligibility criteria:
inclusion criteria: * all participants must be willing to sign informed consent; for patients younger than 18 years old, parents or guardians will sign an informed consent * age \> 4 years. * both sexes. * patients with clinically and dermoscopically diagnosed plane warts. * subject is willing and able to follow all study instructions and to attend all study visits exclusion criteria: * • history of hypersensitivity to any of the drugs used. * pregnancy and lactation. * patients with epidermodysplasia verruciformis syndrome. * patients with eczematous skin disorders. * presence of any active infections e.g. herpes, tuberculosis. * history of topical anti wart treatment within 4 weeks of recruitment to the study, and a 12-week period for systemic anti-wart treatment, or immunotherapy, or hpv vaccine in the last 24 weeks.
mtt for children with both pitt hopkins syndrome and gastrointestinal disorders

Conditions: Pitt Hopkins Syndrome

Summary: the investigators propose to investigate microbiota transfer therapy (mtt) for treating patients with pitt hopkins syndrome (pths) and gastrointestinal problems similar to irritable bowel syndrome (ibs). mtt involves a combination of 10 days of oral vancomycin (an antibiotic to kill pathogenic bacteria), followed by a bowel cleanse, followed by 12 weeks of fecal microbiota (fm).

for children ages 5-17 years with pths and gastrointestinal problems, a phase 2 clinical trial will evaluate the safety, tolerability, and efficacy of mtt. randomized, double-blind, placebo-controlled treatment (14 weeks) the trial will be a randomized, double-blind, placebo-controlled trial which will include a 10-day treatment with oral vancomycin (or placebo), then 1 day of magnesium citrate to cleanse the bowel of vancomycin and bacteria/feces (all participants, since its bowel-emptying effect cannot be blinded), followed by oral administration of fm (or placebo). an initial high dose of fm (or placebo) for two days will be followed by a lower maintenance dose of fm (or placebo) for 12 weeks. group a: real treatment group b: placebo vancomycin, real magnesium citrate, placebo fm

Eligibility criteria:
inclusion criteria: 1. children ages 7-17 years with pitt hopkins syndrome (verified by genetic testing) 2. gi disorder as defined below that has lasted for at least 2 years. 3. no changes in medications, supplements, diet, or therapies in last 2 months, and no intention to change them during the parts 1 and 2 of the clinical trial. 4. ability to swallow pills (without chewing) 5. review of last two years of medical records by the study physician. exclusion criteria: 1. antibiotics in last 3 months 2. probiotics in last 2 months, or fecal transplant in last 12 months 3. tube feeding 4. severe gastrointestinal problems that require immediate treatment (life-threatening) 5. ulcerative colitis, crohn's disease, diagnosed celiac disease, eosinophilic gastroenteritis, or similar conditions 6. unstable, poor health (based on study physician's opinion) 7. recent or scheduled surgeries 8. current participation in other clinical trials 9. females who are pregnant or who are at risk of pregnancy and sexually active without effective birth control. 10. allergy or intolerance to vancomycin or magnesium citrate 11. clinically significant abnormalities at baseline on two blood safety tests: comprehensive metabolic panel, and complete blood count with differential. 12. evidence of significant impairment of immune system, or taking medications that can compromise the immune system, and thus increase risk if exposed to multiple-drug resistant bacteria.

Keywords: microbiota transfer therapy fecal transplant fecal microbiota transplant intestinal microbiota
global linerixibat itch study of efficacy and safety in primary biliary cholangitis (pbc) (glisten)

Conditions: Pruritus

Summary: this is a 2-part study in pbc participants with cholestatic pruritus and will evaluate the efficacy, safety and impact on health-related quality of life of linerixibat compared with placebo.


Eligibility criteria:
inclusion criteria: * male and female participants must be between 18 to 80 years of age inclusive, at the time of signing the informed consent. * participants who have documented pbc. * participants who have moderate to severe itch. exclusion criteria: * total bilirubin \>2.0 times upper limit of normal (uln) using the average of two baseline measures. * screening alanine aminotransferase (alt) \> 6 times uln in a single baseline measure or alt \> 5 times uln using the average of two baseline measures. * screening estimated glomerular filtration rate (egfr) \<30 milliliter per minute per 1.73 square meter (ml/min/1.73m\^2). * history or presence of hepatic decompensation (e.g., variceal bleeding, hepatic encephalopathy or ascites). * presence of hbsag positive hepatitis b or hepatitis c (hcv) (anti-hcv and ribonucleic acid \[rna\] detected) infection, primary sclerosing cholangitis (psc), alcoholic liver disease and/or confirmed hepatocellular carcinoma or biliary cancer. * current clinically significant diarrhea or active inflammatory ileal disease according to investigator´s clinical judgment. * current symptomatic cholelithiasis or cholecystitis. * current diagnosis of primary skin disorders with itch as a characteristic feature (e.g., atopic dermatitis, psoriasis). * primary sleep disorders such as but are not limited to sleep apnea, narcolepsy, hypersomnia. * initiation, discontinuation or change in dose of ursodeoxycholic acid (udca), bezafibrate or fenofibrate in the 8 weeks prior to screening. * use of obeticholic acid: within 8 weeks prior to screening. (participants may not initiate or restart during the study). * initiation, discontinuation, or change in dose of any of the following in the 8 weeks prior to screening: bile acid binding resins, rifampicin, naltrexone, naloxone, nalfurafine, pregabalin, gabapentin, sertraline or other selective serotonin reuptake inhibitor (ssris), antihistamines used for the treatment of itching. * administration of any other human ileal bile acid transporter (ibat) inhibitor in the 12 weeks prior to screening. * any planned procedures intended to treat cholestatic pruritus such as nasobiliary drainage or ultraviolet light therapy from screening and throughout the study. * history of sensitivity or intolerance to the study treatment.

Keywords: cholestasis glisten gsk2330672 itch primary biliary cholangitis pruritus
postmarketing surveillance study for use of menactra® in the republic of korea

Conditions: Meningitis; Meningococcal Meningitis; Meningococcal Infections

Summary: the purpose of the study is to perform the re-examination of menactra® administered in the routine clinical settings in accordance with the ministry of food and drug safety regulation. primary objective: * to describe the safety profile after 1 dose of menactra® administered from 9 months to 55 years of age under standard health care practice.

subjects aged 9 months through 55 years and who are given study vaccine during routine health-care visits will be enrolled in the study. they will be followed-up for up to day 42 following vaccination. no study vaccine will be supplied or administered as part of this study, subjects will be monitored following routine vaccine administration in clinical settings.

Eligibility criteria:
inclusion criteria: * informed consent form signed by the subject (for subjects from 19 to 55 years of age) or the parent(s) or other legal representative (for subjects from 9 months to 18 years of age) * receipt of one dose of menactra® (on the day of inclusion) according to approved local product insert paper . exclusion criteria: * participation at the time of study enrollment (or in the 4 weeks preceding the study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or a medical procedure * subjects who already participated in this study.

Keywords: meningitis meningococcal meningitis meningococcal infections menactra® meningococcal vaccine