Kornimate/medical-research-clean huggingface dataset:
immunogenicity and safety of inactivated h1n1 swine-origin influenza monovalent vaccine in immunocompromised children and young adults

Conditions: H1N1 Pandemic Flu

Summary: this study will evaluate the immunogenicity and safety of inactivated h1n1 swine-origin monovalent influenza vaccine in immunocompromised children and young adults.

this is a prospective observational study. this study will not dictate vaccine administration, nor the vaccine product to be used. it will collect data in st jude patients who will receive the vaccine as part of their clinical care per institutional guidelines. research participants will receive two doses of inactivated h1n1 swine-origin monovalent influenza vaccine administered 28 days apart as part of clinical care. each dose contains 15 mcg of hemagglutinin antigen (ha).follow-up visits will be scheduled 28 days after each dose and at day 208+/- 14 days for blood work. the day of administration of the first vaccine dose is counted as day 0. at each of these visits, blood will be collected to assess for immunogenicity. research participants will be given a diary card to record symptoms for 28 days . they will be asked to bring this diary back at the next visit. other vaccine-related adverse events will also be collected by retrospective chart review. children and young adults between the ages of 6 months and 21 years and 13 kg or greater in body weight who have an underlying diagnosis of cancer, hiv, sickle cell disease or receipt of a stem cell transplant more than a year prior to study entry and who will receive inactivated h1n1 swine-origin monovalent influenza vaccine in the winter/fall of 2009-2010 as part of their routine clinical care.

Eligibility criteria:
inclusion criteria: * age 6 months through 21 years of age at the time of entry into the study; * body weight of 13 kg or greater at the time of entry into the study; * participant is immunocompromised due to cancer, hiv, or sickle cell disease or receipt of a stem cell transplant; * participant or participant's parent/legal guardian available by telephone during the course of the study; * written informed consent (and assent, if applicable) obtained; * potential research participant received or will receive h1n1 swine-origin monovalent influenza vaccine within 24 hours of study entry. exclusion criteria: * proven history, by rt-pcr, of h1n1 swine-origin influenza infection prior to study entry; * receipt of a stem cell transplant within one year prior to study entry; * participation in p1088 study.

Keywords: h1n1 pandemic flu
the study of the phenotype of hereditary xerocytosis

Conditions: Xerocytosis; Phenotype; Genotype

Summary: hereditary xerocytosis is a dominant red blood cell membrane disorder characterized by an increased leakage of potassium from the interior to the exterior of the red blood cell membrane, leading to water loss, red cell dehydration, and chronic hemolysis. in 90% of cases, it is associated with heterozygous gain-of-function mutations in piezo1, a gene that encodes a mechanotransducer responsible for converting mechanical stimuli into biological signals. the remaining 10% of cases are linked to mutations in the gardos channel gene.


Eligibility criteria:
inclusion criteria: * any patient diagnosed with hereditary xerocytosis according to the 2021 pnds guidelines * covered by a social security plan * signature of the consent form for study participation by the patient, or for minors, by the parent(s)/legal representative(s). exclusion criteria: * patients with other hemolysis reason

Keywords: xerocytosis phenotype genotype piezo1 kcnn4 mutation
intermittent oro-esophageal tube on feeding hesitancy in stroke patients

Conditions: Dysphagia

Summary: the aim of this clinical trial is to compare feeding hesitancy of ischemic stroke patients who receive enteral nutrition support through either intermittent oro-esophageal tube or nasogastric tube. patients will be randomly assigned to either an observation group or a control group, with both groups receiving routine rehabilitation treatment. the observation group will receive enteral nutrition support through intermittent oro-esophageal tube, while the control group will receive it through nasogastric tube. researchers will then compare feeding hesitancy of the two groups.

the study will last 15 days for each participant. the aim of this clinical trial is to compare feeding hesitancy of ischemic stroke patients who receive enteral nutrition support through either intermittent oro-esophageal tube or nasogastric tube. patients will be randomly assigned to either an observation group or a control group, with both groups receiving routine rehabilitation treatment. the observation group will receive enteral nutrition support through intermittent oro-esophageal tube, while the control group will receive it through nasogastric tube. researchers will then compare feeding hesitancy of the two groups.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years; * meeting the diagnostic criteria of stroke; * any degree of dysphagia at admission; * steady vital signs. exclusion criteria: * complicated with other neurological diseases; * tracheostomy tube plugged; * unfeasible to the support of parenteral nutrition; * simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.
a study of hc006 in subjects with advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: the purpose of this study is to characterize the safety, tolerability, pharmacokinetics (pk), immunogenicity and preliminary antitumor activity of hc006 in subjects with advanced solid tumor malignancies. this study is a first-in-human (fih) study of hc006 in subjects with advanced solid tumors.

hc006, a novel therapeutic monoclonal antibody that specifically binds to human c-c motif chemokine receptor 8 (ccr8) and is designed to selectively deplete tumor-infiltrating t regulatory cells (tregs) with enhanced antibody-dependent cell-mediated cytotoxicity (adcc). in mouse tumor models, hc006 has demonstrated excellent antitumor activity and safety profile. this first-in-human (fih) study will be conducted in two parts. in the dose-escalation part, testing will be done on up to 31 subjects to determine the maximum tolerated dose (mtd) and the recommended dose (rd). in the dose-expansion part, we will evaluate the safety and efficacy of the recommended dose of hc006 in the treatment of advanced solid tumor subjects without standard therapy.

Eligibility criteria:
inclusion criteria: * subjects must have histologically confirmed and documented diagnosis of locally advanced unresectable or metastatic advanced solid tumor that is refractory to standard treatment, or intolerant to standard treatment, or for which no standard treatment exists. * at least one measurable disease for expansion cohorts per response evaluation criteria in solid tumours (recist) v1.1(dose escalation only requires at least one assessable lesion) * agree to provide archived or fresh tumor tissue samples of primary or metastatic lesions for expansion cohorts. * life expectancy ≥12 weeks * eastern cooperative oncology group (ecog) performance status of 0-1 * have adequate organ function as described in the protocol. * agree to adopt effective contraceptive measures. exclusion criteria: * prior exposure to ccr8 inhibitor or hypersensitivity to any ingredient of the study drug. * treatment with any systemic anti-cancer treatment within 4 weeks before first dose of study drug. * use of any live attenuated vaccines within 28 days. * with primary central nervous system (cns) tumors or unstable cns metastases. * have active or history of autoimmune disease or immunodeficiency disease. * with active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy. * with any mental or cognitive impairment that may limit their understanding, implementation. * major surgery within 4 weeks of study drug administration. * have uncontrolled or severe illness, including but not limited to severe cardiovascular disease, interstitial lung disease or non-infectious pneumonia, or uncontrollable clinical third luminal effusion. * any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of ctcae v5.0. * history of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma. * women who are pregnant or breastfeeding. * other protocol defined exclusion criteria may apply.
the effects of low carbohydrate diet on liver fat content and mitochondrial fluxes

Conditions: Fatty Liver

Summary: the purpose of this study is to examine whether a low carbohydrate diet as compared to simple calorie restriction decreases hepatic lipid content and changes hepatic mitochondrial flux in humans.

in this study, the investigators will examine whether a low carbohydrate diet as compared to simple calorie restriction will change hepatic lipid content and mitochondrial flux in humans. before and after a low carbohydrate diet and a simple calorie restriction intervention, rates of hepatic mitochondrial flux will be assessed using positional isotopomer analysis of 3-13c-lactate during a 3 hour basal period. rates of whole body ketogenesis will be determined using \[13c4\]β-hydroxybutyrate, and whole body glucose metabolism will be measured using \[2h7\]glucose. body composition will be determined with bioelectrical impedance; hepatic lipid content will be measured with mrs. whole-body oxidation of lipids, carbohydrates and protein will be determined using indirect calorimetry.

Eligibility criteria:
inclusion criteria: * age 18-70 * subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent exclusion criteria: * chronic liver disease other than nafld * chronic disease associated with hepatic steatosis such as diabetes mellitus * use of drugs known to affect hepatic steatosis * contraindications for mri * pregnancy or nursing at the time of the study
biomarkers for pain in spinal cord injury (sci) patients

Conditions: Traumatic Spinal Cord Injury; Neuropathic Pain

Summary: the investigators propose to compare plasma protein profiles for sci patients with/without chronic neuropathic pain in order identify biomarker(s) that are associated with this medical condition. secondly, the investigators propose to identify a temporal relationship to initial sci at which these biomarkers manifest. our working hypothesis is that sustained alterations in specific inflammatory molecules are associated with chronic neuropathic pain following sci, and that their plasma levels can serve as biomarkers to identify patients at risk for the development of neuropathic pain. additionally the investigators are collecting skin tissue biopsy samples from patients following acute and chronic spinal cord injury to create vector-free human ips cells from fibroblasts by direct delivery of reprogramming proteins.


Eligibility criteria:
a. chronic patients inclusion: 1. two or more years post traumatic sci with deficit exclusion: 1. \< 18 years of age 2. evidence of brain injury on computed tomography (ct) (sci patients need to be able to comply with completing the pain survey) 3. other medical condition that accounts for chronic pain (i.e. diabetic neuropathy, renal insufficiency, multiple sclerosis, hiv associated neuropathy, alcohol-related neuropathy) 4. temperature \> 100.5°c 5. history of infection within the last 30 days (i.e. uti, uri, pressure sore) 6. history of pulmonary embolus (pe) or deep vein thrombosis (dvt) 7. inability to obtain informed consent 8. psychiatric problems (patients need to be able to complete the pain survey) 9. diagnosis or treatment of cancer in the last 5 years b. longitudinal, prospective cohort patients: inclusion: 1. initial traumatic sci with deficit exclusion: same as listed above c. healthy volunteers healthy volunteers include gender, age and race matched volunteers able to provide informed consent who have, 1. no significant medical history (pain free) 2. no recent infections 3. take no medications 4. fever free 5. greater than 18 years old

Keywords: spinal cord injury sci neuropathic pain pain
diagnosing obstructive lung disease with point of care ultrasound

Conditions: Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive; Asthma; COPD

Summary: the objective of this study is to evaluate the diagnostic accuracy of point of care ultrasound (pocus) in identifying obstructive lung diseases (olds), using pulmonary function tests (pfts) as the gold standard for comparison.

in this cross-sectional diagnostic accuracy test, 200 patients meeting the inclusion criteria will be enrolled to undergo random pocus scans at the respiratory institute of soroka university medical center. these patients, referred for pfts, will be provided with a sonographic score based on several criteria. the study aims to capture comprehensive data, including sonographic results and medical history, to assess the sensitivity, specificity, ppv, and npv of pocus in diagnosing olds. data management and analysis will be the responsibility of the soroka clinical research center, ensuring rigorous oversight and reliable results.

Eligibility criteria:
inclusion criteria: * age 18 or above * referral for full pulmonary function tests (pfts) * patients are willing and able to sign a written informed consent form. exclusion criteria: * unable to give written informed consent. * unable to remain supine. * poor effort at pfts * subcutaneous emphysema

Keywords: point-of-care ultrasound dyspnea pulmonary function tests
study of body composition in patients treated by adjuvant hormonal therapy for breast cancer (metaca2)

Conditions: Hormonal Therapy; Breast Cancer

Summary: this cross-sectional study of pathophysiology will bring additional informations on body composition of patients treated by adjuvant hormonal therapy for breast cancer. this is a complementary study of metaca study (au882).


Eligibility criteria:
inclusion criteria: * postmenopausal women * patients requiring hormonal treatment * who performance status 0-2 * patients initially included in metaca (au882) protocol * affiliation to a social security scheme (or be the beneficiary of such a plan) * patients who signed the informed consent form exclusion criteria: * patients witg relapse, with metastases or other cancer * concurrent treatment with a drug test, or participation in a clinical trial within \< 30 days * patients carrying an electronic medical device (eg pacemaker) * patients who refused to sign the consent form

Keywords: body composition
effectiveness of artificial intelligence - assisted colonoscopy in colorectal neoplasms

Conditions: Colonic Neoplasms; Colonic Polyp; Diagnosis

Summary: the primary goal of this study is to estimate the effectiveness of a medical decision support system based on artificial intelligence in the endoscopic diagnosis of benign tumors. researchers will compare adenoma detection rate between "artificial intelligence - assisted colonoscopy" and "conventional colonoscopy" groups to evaluate the clinical effectiveness of artificial intelligence model.

the primary outcome is adenoma detection rate per patient. the secondary outcomes will be measured: * polyps detection rate (all type of lesions) per patient; * number of adenomas per patient; * number of polyps per patient;

Eligibility criteria:
inclusion criteria: * screening coloscopy is needed exclusion criteria: * indications for colonoscopy * previously detected colorectal neoplasms * previously performed colorectal surgery * colorectal cancer * inflammatory bowel disease
the effect of intra-abdominal pressure on peritoneal perfusion during laparoscopic colorectal surgery

Conditions: Laparoscopic Surgery; Pneumoperitoneum

Summary: peritoneal perfusion during laparoscopic surgery is quantified by video recording after intravenous injection of indocyanine green at a pneumoperitoneum pressure of 8, 12 and 16 mmhg.


Eligibility criteria:
inclusion criteria: * adults (≥ 18 years old) * scheduled for robot-assisted colorectal laparoscopic surgery exclusion criteria: * severe liver- or renal disease * pregnancy or lactation * planned diagnostics or treatment with radioactive iodine \< 1 week after surgery * bmi \>35 kg/m2 * known or suspected hypersensitivity to indocyanine green, sodium iodide or iodine * hyperthyroidism or thyroid adenomas * use of medication interfering with icg absorption as listed in the summary of product characteristics.

Keywords: laparoscopic surgery pneumoperitoneum peritoneal perfusion intra-abdominal pressure
comparative effect of 3 different cranberry extracts on cystitis related urinary comfort in women

Conditions: Recurrent Cystitis

Summary: urinary discomfort includes a set of signs such as an urgent need to urinate, high frequency of urination per day, discomfort / difficulty or burning sensation when urinating, smelly urine. this urinary discomfort represents in women 2 to 5% of the reasons for consultation (berg, 1991) and can have various etiologies but the bacterial origin is the most frequent. cranberries are traditionally used for urinary comfort and the prevention of urinary disorders with bacterial origin. the study objective is to collect in real life efficacy and tolerance data from the consumption of 3 cranberry extracts in order to highlight the qualitative and quantitative characteristics of these extracts which are directly involved in the improvement of urinary discomfort or situation of recurrent cystitis symptomatic episodes in women.


Eligibility criteria:
inclusion criteria: * having had at least 3 symptomatic episodes of cystitis (including 1 urinary tract infection confirmed by a doctor) during the last 12 months * whose episode had a significant impact on quality of life / urinary discomfort (acss dimension qol ≥ 2) * had a smartphone compatible with nurstrial smartphone application (e-crf) exclusion criteria: * to be a pregnant or breastfeeding woman or planning to be pregnant within 6 months, * currently taking any other supplementation for urinary comfort or having taken any other cranberry-based food supplement in the past 3 months, * to be under antibiotic treatment or during the last 7 days preceding inclusion, * have urinary discomfort with a severe impact on quality of life (acss qol\> 7) during the last 24 hours prior to inclusion, * have an allergy known to plants of the cranberry family or to one of the components of the products.
local and intraperitoneal analgetics in gynecologic laparoscopy for post operative pain relief

Conditions: Postoperative Complications

Summary: a comparison between local and intraperitoneal analgetics to placebo, during laparoscopy, regarding post operative pain.

4 randomly assigned groups. grop 1 will get sub cutaneous and intraperitoneal marcain. grop 2 will get sub cutaneous marcaine and intraperitoneal saline. grop 3 will get sub cutaneus saline and intraperitoneal marcaine. grop 4 will get ub cutaneous and intraperitoneal saline

Eligibility criteria:
inclusion criteria: * elective laparoscopy exclusion criteria: * laparotomy vaginal operations oncologic operations chronic use of analgetics due to pelvic pain pregnancy operations lasts more than 3 hours
effect on pre-operative anxiety of a personalized three-dimensional kidney model prior to nephron-sparing surgery for renal tumor.

Conditions: Kidney Neoplasms; Carcinoma, Renal Cell

Summary: investigators aimed to estimate the effect of showing and handling a three-dimensional modelization of a patient's kidney presenting with tumor the day before his nephron-sparing surgery. the main outcome measure was the effect on anxiety assessed via the stai score. 2 types kidney models (virtual and printed) will be evaluated as compared to usual information, using a randomization.

announcement of serious illnesses and especially cancerous diseases has major impacts on one's psychological field. need of surgery can create even other fears due to its unknown nature. use of tools to decrease anxiety and enhance understanding prior to surgery is a key point in comprehensive care that is way not enough promoted for now. in the field of surgery, available methods to deal with pre-operative anxiety are massively represented by anxiolytics drugs, only few other devices were evaluated. technological development in healthcare has seen the rising of three-dimensional media, especially in surgery, for procedure planning. there is no doubt that this tool is effective in helping surgeons regarding the studies published within the past few years but there is no such evidence concerning the benefit for patients. some authors report improvement of patients understanding and great satisfaction referring to the usefulness of this tool. but none of these papers evaluated anxiety. the goal of our research is to measure the effect of a personalized three-dimensional model of patients' kidney on pre-operative anxiety. for this purpose investigators will randomly assign a total of 66 patients planned to have a nephron-sparing surgery for kidney tumor in 3 different groups. inside the 2 interventional groups, patients' kidneys will be modelized in three dimensions, one group will then be 3d-printed. the third group will be control with usual preoperative information. the day before surgery, 3d models will be presented to their respective owner. all patients will have to complete a survey evaluating their anxiety level and also their understanding of renal anatomy and surgical procedure.

Eligibility criteria:
inclusion criteria: * consecutive patients presenting with renal tumor allowing a nephron-sparing surgery * participating in uroccr database * having a contrast abdominal scanner prior to surgery * owing social insurance contract * inpatient surgery exclusion criteria: * unable to give informed consent * no contrast scanner

Keywords: kidney neoplasms carcinoma, renal cell nephron-sparing surgery 3d modeling 3d printing anxiety personalized medicine
serotonin 1a agonists and cognition in schizophrenia

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: examines cognitive functioning in patients with schizophrenia or schizoaffective disorder who have been treated with antipsychotic medications. patients will be assigned to take active medication (buspar)or placebo along with their prescribed antipsychotic medication for six weeks. patients' memory and problem-solving ability will be tested before and after medication.

examines cognitive functioning in patients with schizophrenia or schizoaffective disorder who have been treated with olanzapine or risperidone for at least three months randomized to receive adjunctive treatment with a 5-ht1a agonist (buspirone, 15-30 mg/day)or placebo.

Eligibility criteria:
inclusion criteria: subjects must meet all of the following criteria to be eligible for participation in the current research study. 1. subjects will be males and females between 18-65 years of age; 2. subjects will have a definite diagnosis by dsm-iv criteria for schizophrenia or schizoaffective disorder; 3. the subjects or their legal guardian must sign the informed consent; 4. subjects currently being treated with olanzapine or risperidone for a duration of at least 3 months exclusion criteria: 1. subjects who are pregnant or lactating 2. subjects who have brain damage and/or neurological disorders 3. subjects who have current substance dependence 4. subjects unable to provide informed consent