Kornimate/medical-research-clean huggingface dataset:
follow-up yttrium-90 internal pair production pet/ct vs brehmsstrahlung imaging in patients with primary/metastatic liver tumors

Conditions: Liver Cancer; Hepatic Tumors

Summary: this is a prospective non-blinded case series involving the acquisition of a pair production pet/ct as soon as possible after an already performed y-90 sirspheres treatment of hepatic malignancy. it will be performed in addition to the standard brehmsstrahlung spect scan. the sequence of the two scans in each case (pet/ct vs spect) will be determined by availability of the scanners at the time. however, it is intended that both be acquired on the day of the y-90 treatment. the length of subject participation will be one year. the measures used will be mostly qualitative in nature, and will include: * correlation with expected vs. achieved tumor coverage by the treatment * correlation between treatment distribution depicted by brehmsstrahlung scans vs. the internal pair production pet/ct scans, to. * detection of non-target embolization, where applicable, and qualitative comparison between the two modalities as to the conspicuity of the abnormality qualitative methods will be used by the analysis of the obtained pet/ct images and comparing them to the brehmsstrahlung spect images as previously described.


Eligibility criteria:
inclusion criteria: * recipient of selective internal radiation treatment within 5 days. * anticipated ability to remain still for up to 40 minutes exclusion criteria: * anticipated inability to lie still for up to 40 minutes * severe claustrophobia * significant cardiovascular instability, or instability of other medical/surgical conditions, such that it would be deemed unsafe or technically not feasible to obtain a pet/ct, as determined by the any member of the investigative team * failed deployment of the planned y-90 treatment for any reason * duration of time longer than 5 days since administration of the y-90 treatment * age \<18 * known pregnancy

Keywords: liver cancer hepatic tumors primary liver tumors metastatic liver tumors yttrium-90 y-90
probiotics and the neurodevelopment in the premature infant <32 weeks gestational age and <1500g

Conditions: Infant, Newborn, Diseases; Infant Development

Summary: unicentric, quasi-experimental, cohort study to evaluate the effect of combining two probiotics (bifidobacterium bifidum ncdo 2203 and lactobacillus acidophilus ncdo 1748) in the neurodevelopment of preterm neonates below 32 weeks' gestation and a birthweight under 1,500 g. this probiotic combination has shown to be safe and beneficial in premature neonates in the prevention of nec. the investigators hypothesised that this mixture would contribute to better neurodevelopmental outcomes of preterm neonates when assessed at 24 months corrected age. additionally, neurodevelopment improved would be more relevant at 6 years of age, together with a better pattern of neuronal plasticity biomarkers. secondarily, this mixture of probiotics could reduce nec, los, intraventricular haemorrhage and neonatal mortality in accordance with previous studies.


Eligibility criteria:
inclusion criteria: * premature infants under 32 weeks gestational age and less than 1500g birthweight. * born at bcnatal hospital clínic between years 2014-2019. exclusion criteria: * all neonates presenting with suspected congenital anomalies, inborn errors of metabolism, or genetic defects were excluded. * infants with a suspected syndrome, or who have suffered events beyond the neonatal period, not related to prematurity, that could entail impairment in neurodevelopment (severe cranioencephalic trauma, oncological process, meningitis, or exposure to toxic substances)

Keywords: probiotics bifidobacterium bifidum lactobacillus acidophilus neurodevelopment prematurity late-onset sepsis
conversion from tacrolimus to cyclosporine microemulsion in liver transplant patients with new onset diabetes after the 3rd month post-transplant

Conditions: Maintenance Liver Transplant Patients With New Onset Diabetes

Summary: the trial is conducted in patients who have received a liver transplant, were prescribed tacrolimus to prevent organ rejection and developed diabetes from 3 month post-transplantation onwards. the goal of the trial is to assess the percentage of patients in whom diabetes will resolve 6 month after conversion from tacrolimus to cyclosporine micro-emulsion as measured by a fasting blood glucose \< 1,26 g/l without the need of hypoglycemic treatment.


Eligibility criteria:
inclusion criteria: * - patients who have received a first liver transplantation and who are 18 to 70 year old * patients who are treated with tacrolimus post-transplant for at least 3 months and for a maximum of 36 months * patients without any known diabetes before transplantation and in whom diabetes mellitus was diagnosed for the first time at least 3 months post-transplantation exclusion criteria * re-transplantation or multi-organ transplantation, * diabetes before the transplantation, * type i diabetes mellitus. other protocol-defined inclusion / exclusion criteria may apply

Keywords: cyclosporine, liver transplantation, maintenance, diabetes
observational study for sir-spheres therapy for the treatment of hcc patients in china

Conditions: Hepatocellular Carcinoma (HCC); Hepatocellular Carcinoma Non-Resectable

Summary: yttrium-90 (y90) microsphere injection solution was approved by the nmpa in 2022. currently, there is a lack of summary of real-world data in china. therefore, this retrospective real-world study is intented to explore the characteristics and efficacy of hcc patients treated with y90 in china, aiming to provide reference for guiding and optimizing clinical practices and subsequent confirmatory clinical studies for the treatment of hcc patients in china.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old; 2. confirmed diagnosis of hcc 3. treated with yttrium-90 during 2023.1.1 - 2024.6.30 and assessed at least once for tumor response within 6 months following treatment exclusion criteria: no formal exclusion criteria in a real-world study

Keywords: yttrium 90 y-90 hcc sirt
malaria incidence in infants in bancoumana, mali

Conditions: Malaria Infection; Malaria Incidence; Anemia

Summary: this study, conducted by the malaria research and training center at the faculty of medicine in bamako and the niaid will measure the frequency of occurrence of malaria in infants in bancoumana, mali. information from the study will help in planning trials of malaria vaccines. healthy children from 6 weeks to 6 months of age who live in the bancoumana health area may be eligible for this study. candidates are screened with a physical examination and blood tests. participating children are visited at home for a total of about 17 visits to see if they are well. they come to the clinic every month during the 7-month study for a clinical evaluation, including a blood sample obtained by finger prick to test for malaria. some of the blood collected may be stored and used for research. children who become sick with malaria are treated for the disease.

this is an observational study to determine the burden of malaria in rural malian infants. infants will be identified during a village-wide census and at expanded program for immunization (epi) visits. after obtaining community consent, eligible infants' parents will be invited to bring infants to the clinic for screening. enrolled infants will receive a baseline evaluation and monthly visits during the rainy season at which times they will receive interim evaluations and heel, toe, or finger pricks for determinations of hemoglobin, thick and thin blood films, malaria antibody titers (at first and last visit for each transmission season), and hemoglobin typing at one visit. study subjects will also receive a weekly home visit to determine if they are well or ill. if ill or febrile at any visit, or if they present to the clinic for an unscheduled visit, subjects will receive a history and physical examination, heel, toe, or finger pricks for determinations of hemoglobin, thick and thin blood films, filter paper blood collection and an rdt for malaria. diagnosis and treatment of malaria will be performed according to mali national malaria control program (nmcp) guidelines. diagnosis and treatment of other conditions will be performed as determined by the treating clinician.

Eligibility criteria:
* inclusion criteria: 1. infants at least six weeks to less than 7 months of age at enrollment 2. known residents of the bancoumana health area 3. good general health as determined by clinical exam 4. available for the 6-7 months duration of the trial 5. willingness to participate as evidenced by signing of the informed consent or fingerprinting by the parent or guardian exclusion criteria: 1. social, behavioral, cognitive, or psychiatric condition that in the opinion of the investigator affects the ability of the volunteer or the parent/legal guardian to understand and cooperate with the study protocol 2. participation in an investigational vaccine or drug trial within 30 days of starting this study, or while this study is ongoing 3. infant born to mother with known or suspected hiv/aids as determined by the clinician

Keywords: malaria incidence anemia clinical malaria
a study of alks 4230 (nemvaleukin alfa) with pembrolizumab in head and neck cancer

Conditions: Squamous Cell Carcinoma of Head and Neck

Summary: the primary objective of this study was to estimate the response rate to alks 4230 in combination with pembrolizumab in patients with hnscc who had previously received anti-pd-(l)1 therapy but who had not achieved a cr.


Eligibility criteria:
inclusion criteria: * patients must have histologically or cytopathologically confirmed diagnosis of non-cutaneous squamous cell carcinoma of the head and neck region that is locally advanced and/or recurrent and no longer amenable to local surgical or radiation therapy and/or with evidence of distant metastatic disease * patients must have had anti-pd-(l)1 therapy as the most recent systemic therapy with either stable disease or partial response on prior anti-pd-(l)1 therapy, or progressive disease on prior anti-pd-(l)1 therapy * patients must have disease that is measurable by recist v1.1 * patients must be willing to provide tumor tissue biopsy * patients must demonstrate adequate organ function * female patients of childbearing potential should have a negative pregnancy test within 72 hours prior to receiving the first dose of study medication * patients must agree to follow contraceptive requirements defined in the protocol * additional criteria apply exclusion criteria: * patient is pregnant or breastfeeding or expecting to conceive or father children * patient has an active major infection requiring systemic therapy within 1 week of starting study drug * patient has known active central nervous system (cns) metastases and/or carcinomatous meningitis. patients with previously treated brain metastases may participate, provided that they are stable, have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to study drug * patient has hypersensitivity to pembrolizumab, alks 4230, or any of their excipients * patient has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (inhaled or topical steroids and steroid replacement at physiologic doses are allowable) * patient has prior grade ≥3 immune-related toxicities requiring systemic immunosuppressant treatment that were attributable or possibly attributable to pd-1 immune checkpoint blockade * patient has active tuberculosis or known active infection with hepatitis b or hepatitis c * patient has known psychiatric or substance abuse disorders or a social situation that would interfere with cooperation with the requirements of the study * additional criteria apply

Keywords: alkermes il-2 interleukin-2 oncology immuno-oncology cytokine immunotherapy alks 4230 pembrolizumab keytruda pd-l1 solid tumors
a study evaluating the gastrointestinal (gi) safety and tolerability of aliskiren compared to ramipril in essential hypertension

Conditions: Hypertension

Summary: this study will evaluate the long-term gastrointestinal (gi) safety and efficacy of aliskiren (300 mg) compared to ramipril (10mg) in patients ≥ 50 years with essential hypertension.


Eligibility criteria:
inclusion criteria: * male or female outpatients, 50 years of age and older with a diagnosis of essential hypertension * successful high quality colonoscopy at baseline including visualization of the entire colon and the cecum as confirmed by a photograph and collection of the rectal and cecal mucosal biopsy samples * all rectal, colon or cecal polyps found at baseline colonoscopy must be completely resected endoscopically at the time of the procedure. * patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation have been clearly explained to them (written informed consent). exclusion criteria: * previously treated in an aliskiren study. * current evidence of inflammatory bowel disease, the presence of colonic ulcerations (or other indices of colitis of any type) or colorectal carcinoma including carcinoma in situ found at baseline colonoscopy. * history of gastrointestinal carcinoma, crohn's disease, ulcerative colitis, microscopic colitis. * history of familial polyposis or hereditary nonpolyposis colorectal cancer. * history of confirmed diverticulitis within 12 months of visit 1. * history of celiac disease (gluten intolerance). * history of or current evidence on the baseline colonoscopy of melanosis coli.

Keywords: hypertension, aliskiren, ramipril, colonoscopy
phase iii open study, prospective, multicenter, randomized, comparative to the positive control for evaluating the efficacy and safety of auris-sedina in the symptomatic control of otalgy in patients with or without acute external otitis.

Conditions: Otitis; Efficacy; Tolerability

Summary: to evaluate the efficacy and tolerability of auris-sedina in the symptomatic control of otalgy in patients with and without acute external otitis compared with use of otosynalar®.

phase iii open study, multicenter, prospective, randomized entrance of a total of 188 patients, 94 patients will receive medication test and 94 patients will receive otosynalar®. patients will be assessed until the clinical condition has been resolved or a maximum of 3 days. 188 patients of either gender or race, who have at least two of the following symptoms: pain, discharge, tinnitus, ear fullness, subjective hearing loss temporary dizziness or vertigo. and with a clinical or non-acute external otitis.

Eligibility criteria:
inclusion criteria: * patients with otalgy or not, with acute external otitis ; * patients with at least two symptoms of otalgy (pain, discharge, tinnitus, ear fullness, subjective hearing loss temporary dizziness or vertigo) with the visual analogic scale score between 4 and 8 (mild to moderate); * the patient must present otalgia in one ear; * children above 6 years of age; * adults over 18 years of age; * patients who consent to participate in the study; * patients who are female and are of childbearing age should use reliable method of contraception and have negative pregnancy test. exclusion criteria: * patients with sensitivity to any component of the formula; * patients pregnant or lactating; * non visualization of the tympanic membrane of obstruction by cerumen; * patients with evidence of any wound or scratch on the ear (ulcerative lesion); * patients who are making use of any other medication that might interfere with the evaluation of effectiveness of study (such as antibiotics, antiinflammatory, solutions ear); * patients who have severe classification in the visual analogic scale score 9 or 10 in any of the symptoms listed in the questionnaire; * patients with otalgy not otological origin; * patients with otitis, except acute external otitis ; * patients who have epiglottitis; * the patient with infection; * patients who can not follow the procedures clarified in this protocol.

Keywords: auris-sedina otitis efficacy tolerability
comparison of remnant preserving versus remnant resecting anterior cruciate ligament reconstruction

Conditions: Anterior Cruciate Ligament Rupture

Summary: anterior cruciate ligament injury is very common knee injury. especially anterior cruciate ligament complete rupture leads to knee joint instability and degenerative change of the knee. anterior cruciate ligament reconstruction is performed for resolving these problems and it gives excellent results. for leading to successful result of anterior cruciate ligament reconstruction, selecting of appropriate femoral tunnel and tibial tunnel is necessary. if selecting inappropriate tibial tunnel location makes pain, synovitis, impingement of transplanted tendon, loss of range of motion, instability, failure of transplantation and risk of arthritis. it is known that selection of inappropriate tibial tunnel location is the most common cause of anterior cruciate ligament reconstruction failure. recently many studies reconstructed at anatomical lesion instead of isometric point. and some cadaver studies reported that tibial insertion of anterior cruciate ligament has "c" shape. there are two methods for anterior cruciate ligament reconstruction. one is preserving remnant and the other is removing remnant. this study aims to compare the tibia and femoral tunnel location of remnant preserving and remnant resecting anterior cruciate ligament reconstruction.

the study design is a double-blind randomized controlled trial. randomly, twenty patients planed to undergo anterior cruciate ligament reconstruction using autograft by remnant preserving and other twenty patients undergo anterior cruciate ligament reconstruction using autograft by resecting anterior cruciate ligament. the clinical outcome is comparative preoperative, postoperative 6weeks, 3months, 6months and 1years. and clinical score consists of visual analog score, lachman test, anterior laxity, lysholm knee score, international knee documentation committee score. femoral and tibial tunnel location will be analyzed by three-dimensional computed tomography using bernard quadrant method after surgery. the present study aimed to determine and compare (1) the accuracy of tibia and femoral tunnel location and (2) postoperative functional outcome after anterior cruciate ligament reconstruction between remnant preserving group versus remnant resecting group.

Eligibility criteria:
inclusion criteria: * over 19 years old * patients for acl reconstruction having medicare insurance exclusion criteria: * infection * previous surgery experience * progressive osteoarthritis
serious games as emerging e-health interventions for young people with neurological or respiratory disorders

Conditions: Serious Game; Asthma in Children; Children, Only

Summary: the main purpose of 'serious games' (sg) is to provide opportunities for constructive learning and training. they are well-accepted instruments in therapeutic interventions and have been found to be efficient to improve cognitive areas, social interaction and motor skill function. the sg is expected to improve asthmatic children's behaviour by providing a positive psychosocial experience with positive effects on asthma outcomes. participants will be subjected to sg as part of routine medical care, and researchers will study the effect of sg. the aim of the study is to evaluate the impact of an innovative sg on neurobehavioural patterns through a randomised controlled pilot study in adolescents with controlled asthma and on the modulation of the expression pattern of ctra 'conserved transcriptional response to adversity'.


Eligibility criteria:
inclusion criteria: * diagnosis of controlled asthma according to gina recommendations (http://ginasthma.org) exclusion criteria: * flare-ups requiring oral corticosteroids within the last four weeks * use of leukotriene receptor antagonists or therapy as required in the last four weeks * respiratory infections within the last four weeks * immunological, metabolic, cardiac or neurological diseases * obesity * preterm birth * major malformations of the respiratory system * active smoking * pregnancy
feeding trial in pediatric patients

Conditions: Developmental Disabilities

Summary: this is a single center, prospective, non-randomized, uncontrolled, observational study of the use of an enteral nutrition product in pediatric patients with developmental disabilities.

this prospective observational study seeks to assess ability to achieve enteral feeding goals with a new tube feeding product in pediatric patients with developmental disabilities.

Eligibility criteria:
inclusion criteria: * child aged 1-13 years old with development disabilities * currently tolerating enteral feeding * requiring nutritional management to meet 50-90th% weight for age on the kennedy kreiger growth charts * requires enteral tube feeding for at least 14 days. exclusion criteria: * unable to access gastrointestinal tract for feeding via tube * other condition which contraindicates tube feeding

Keywords: developmental disabilities enteral nutrition tube feeding nutrition support
reset for the treatment of stimulant use in hiv clinics: care optimization supporting treatment adherence (costa)

Conditions: HIV Infections

Summary: the purpose of this study is to find out if reset, an fda authorized mobile therapeutic, is effective in treating stimulant use disorder and helping keep hiv viral load suppression stable among men who have sex with men who are living with hiv and have a stimulant use disorder.


Eligibility criteria:
inclusion criteria: * identifies as male or as a female, who was assigned male sex at birth and who has not undergone any hormonal treatment; * reports past year anal intercourse with a male, or identifies as a man who has sex with other men; * age 18 or older (reset is only approved for use with adults); * person living with hiv who is an aids healthcare foundation (ahf) patient at one of the four metro areas: atlanta, dallas/fort worth, fort lauderdale, los angeles; * screens positive for a moderate or severe stimulant use disorder in the last 3-months using the alcohol, smoking and substance involvement test (assist); * reports that he is not currently in drug treatment; * currently has an active antiretroviral therapy prescription and reports \< 90% hiv tx adherence on the 3-item wilson measure in the past 30 days69; * has an iphone, android smartphone or a tablet computer; * can obtain access to stable internet with privacy acceptable to the participant at least twice a week\* * indicates being able to understand english (reset is only available in english; can be read or heard); * consents to participation in the study. exclusion criteria: * otherwise eligible participants will be excluded if they appear to have diminished capacity to consent either because of cognitive impairment or severe psychiatric symptoms (e.g., mania, psychosis). * patients who can benefit from another type of treatment because of severity of stimulant use disorder or opiate use disorder will be referred appropriately. * we will exclude persons residing in criminal justice facilities because they will not have access to a mobile device as required by reset.

Keywords: substance use adherence to anti-retroviral therapy