Kornimate/medical-research-clean huggingface dataset:
evaluation of maralixibat in biliary atresia response post-kasai

Conditions: Biliary Atresia

Summary: a study to evaluate the efficacy and safety of maralixibat in infants with biliary atresia (ba) after hepatoportoenterostomy (hpe, also known as the kasai procedure).

this is a double-blind randomized, placebo-controlled study in subjects with biliary atresia with a primary endpoint at week 26 followed by long-term open-label period during which all subjects will receive maralixibat to week 104.

Eligibility criteria:
inclusion criteria: 1. male or female subjects with body weight ≥2500 g, who are ≥21 days old and \<90 days old at the time of hpe (kasai) 2. hpe or kasai procedure within 3 weeks prior to randomization 3. clinical diagnosis of biliary atresia exclusion criteria: 1. subjects with intractable chronic diarrhea at randomization 2. subjects not tolerating enteral feeds at randomization 3. history of ileal resection 4. diagnosis of biliary atresia splenic malformation syndrome or cystic biliary atresia 5. evidence of another non-biliary atresia pathology involving the intrahepatic bile duct (e.g., paucity, sclerosing cholangitis) 6. evidence of liver failure (e.g. significant ascites)

Keywords: biliary atresia kasai biliary tract diseases bile duct diseases congenital abnormalities
evaluation of reader training processes

Conditions: Alzheimer's Disease

Summary: this study is designed to evaluate the agreement between florbetapir f 18 scan interpretation in the clinic and by expert readers.


Eligibility criteria:
inclusion criteria: - scan obtained for clinical reasons exclusion criteria: - none
go fish: omega-3 fatty acid supplementation in diabetes-related kidney disease

Conditions: Diabetes

Summary: in this application the investigators describe plans for a randomized controlled cross-over trial to determine the effects of omega-3 fatty acid supplementation on urine protein excretion in 30 adults with diabetes (niddm) and kidney disease defined by the presence of proteinuria.

diabetes is the most common cause of end-stage kidney disease in the united states. half of patients with diabetes develop kidney disease. the benefits of omega-3 fatty acids have been shown in animal models of kidney injury. mechanistic studies of omega-3 fatty acid supplements support biological plausibility: omega-3 supplements have been shown to improve vascular reactivity, lower oxidative stress, reduce inflammation, and have beneficial effects on the metabolism of eicosanoids favoring synthesis of vasodilatory prostaglandins and thromboxanes. however, in spite of overwhelming evidence for a potential benefit of dietary omega-3 fatty acids at preventing or slowing progression of kidney disease for adults with niddm, clinical trials providing evidence to support recommendations of supplementation are lacking. the current recommendation for omega-3 intake for adults, one gram/day of dha+epa, is based on evidence for cardiovascular disease risk (cvd) reduction. whether omega-3 fatty acid prevents or slows progression of diabetic kidney disease, whether the current recommended dose is adequate to modify disease, or whether a higher dose should be recommended, needs to be determined. in this setting, we propose to conduct a randomized placebo-controlled cross-over clinical trial to determine the effects of a daily dose of omega-3 fatty acid supplementation (4.0 g/day) compared with placebo on urine protein excretion and biomarkers of kidney injury and function in adults with diabetes and proteinuria.

Eligibility criteria:
inclusion criteria: * participants have a diagnosis of diabetes (either oral medication or diet controlled) * have an average systolic blood pressure (sbp) \<150 and diastolic blood pressure (dbp) \<90 mmhg * have quantified proteinuria -- urine albumin/creatinine ratio of \> 17 mg/g (men) and \>25 mg/g (women) (i.e. at least microalbuminuria). * participants must be on stable doses of antihypertensive, hypoglycemic, and lipid lowering medications for a minimum of two months prior to randomization. participants must agree to stay on stable doses of diabetes, antihypertensive and lipid medication for the duration of the study. exclusion criteria: * major exclusion criteria will be poorly controlled diabetes (hemoglobin a1c \>9%) * use of insulin * use of fish oil supplements or are unwilling to stop fish oil supplements one month prior to randomization and refrain from the supplements during the study * stage 4 or stage 5 ckd or a screening urine protein/creatinine ratio of \>2.5.

Keywords: randomized trial omega three fatty acids
observational study of travellers pathologies

Conditions: Travel-Related Illness

Summary: traveling to emerging countries is associated with a significant risk of encountering health issues specific to the destination, such as gastrointestinal and respiratory infections, malaria episodes, and road traffic accidents.these conditions are associated with behavioral, geographical, or environmental risk factors. a better understanding of these factors will enable the development of targeted recommendations to minimize travel related health issues. the main objective of this study is to determine the incidence of pathologies occurring during travel outside the metropolitan territory.

traveling to emerging countries is associated with a significant risk of encountering health issues specific to the destination, such as gastrointestinal and respiratory infections, malaria episodes, and road traffic accidents.these conditions are associated with behavioral, geographical, or environmental risk factors. a better understanding of these factors will enable the development of targeted recommendations to minimize travel related health issues. the main objective of this study is to determine the incidence of pathologies occurring during travel outside the metropolitan territory. furthermore, two key aspects from a public health perspective are associated with travel and the globalization of exchanges: the acquisition of emerging pathogens or pathogens with antimicrobial resistance of concern. to study these two aspects, the eop study includes two sub-studies called eop-arbo and eop-amr. * eop-arbo : the objective of this sub-study is to determine the risk of contracting an arboviral disease during travel, as well as the factors that may favor infection. for this, blood samples will be collected. * eop-amr : the objective of this sub-study is to determine the risk of contracting an antibiotic-resistant bacteria during the trip. for this, faecal samples will be collected.

Eligibility criteria:
1. inclusion criteria : 1. for all participants in the eop study : * major subject (age ≥ 18) * owns a smartphone compatible with electronic data collection * preparing to travel outside mainland france * affiliated with or covered by social security or private insurance * willing to participate in the eop study 2. for the eop-arbo sub-study : - subject who has consented to participate in the eop_arbo study. 3. for the eop-amr sub-study : * subject who has consented to participate in the eop_amr study. 2. exclusion criteria: 1. for all participants in the eop study : * travel duration ≤ 3 days * travel duration \> 12 months * person traveling as part of an expatriation without planned movement outside the settlement in the destination country * person under legal protection or unable to express consent for participation 2. for the eop-arbo sub-study : - individuals deemed clinically and/or biologically unfit by the investigator to undergo the blood samples required for the study. 3. for the eop-amr sub-study : * no specific exclusion criteria.

Keywords: travel risk factors pathology arbovirose
reconstructive ear surgery in pediatrics

Conditions: Ossicle Chain Disarticulation

Summary: the aim of the study is 1. evaluation of preoperative degree of hearing loss in pediatric population. 2. evaluation of types and prevalence's of ossicular disruptions due to chronic otitis media and trauma. 3. assessment of best candidates for hearing restoration surgeries. 4. comparing different surgical techniques for hearing restoration in various ossicular disorders . 5. evaluation of degree of surgical restoration of the sound transmitting mechanism of the middle ear in pediatric population.

conductive hearing loss (chl) results from impaired transmission of sound from the external auditory canal across the middle ear structures to the cochlea of the inner ear. a variety of disorders can affect the sound transmission pathway at the level of the ear canal, tympanic membrane, and ossicles prior to reaching the hearing organ. ossiculoplasty is the surgical restoration of the sound transmitting mechanism of the middle ear. ossiculoplasty has been performed as early as the 1950s.a myriad of prosthetics and surgical techniques have been described over the last half-century, with no overall consensus on the ideal method of treatment. pediatric population are commonly known to develop conductive hearing loss secondary to various conditions such as chronic otitis media, otitis media with effusion, atelectatic otitis media and head trauma. various methods have been fashioned to restore hearing in such patients however no consensus to the most optimum method for hearing restoration has been well established

Eligibility criteria:
inclusion criteria: 1. patients aged ≤ 18years with chl. 2. patients who are candidate for ossiculoplasty as surgical treatment for them. exclusion criteria: 1. patients with preoperative sensory neural hearing loss (snhl). 2. patient with intra operative complications. 3. patients with intracranial and intratemporal complications. 4. patients with stapes foot plate fixation, broken graft and missed patients. 5. patients \>18years. 6. patients who unfit for surgery.
effect of one-time versus three-times of umbilical cord milking on neonatal hemoglobin in late preterm

Conditions: Umbilical Cord Milking

Summary: to compare the neonatal hemoglobin (hb) in late preterm between one-time versus three-times of umbilical cord milking (ucm)

this was a double-blind randomized controlled trial that performed between may 2021 to march 2022 at the obstetrics and gynecology department of queen savang vadhana memorial hospital. late preterm pregnant women (34-36+6 week's gestation) that exclude placenta accrete/percreta, placenta previa, placental abruption, congenital anomaly and hydrops fetalis, were randomized in a 1:1 ratio to either one-time or three-times ucm. the primary outcome was neonatal hb level at 48-72 hour after birth.

Eligibility criteria:
inclusion criteria: * late preterm pregnant women (34-36+6 week's gestation) exclusion criteria: * placenta accrete * placenta percreta * placenta previa * placental abruption * congenital anomaly * hydrops fetalis
head- to head comparison of [68ga]ga-psma-11 with [18f]psma-1007 pet/ct in staging prostate cancer using histopathology and immunohistochemical analysis as reference-standard

Conditions: Prostate Cancer

Summary: psma (prostate specific membrane antigen) is overexpressed in prostate cancer cells. the 68ga-psma pet / ct test, using small molecules that bind to the psma protein and undergo intercellularization, is a test that has been shown to be more sensitive and specific than other conventional and molecular imaging modalities (ct, mri, bone mapping, disease in prostate cancer patients and its consequences often change therapeutic decisions in patients. in light of this, the examination of the health basket of the state of israel was introduced to the staging of patients at moderate or high risk, as well as to the extent of the disease in patients with biochemical failure. however, testing with 68ga-psma has several limitations, resulting from the use of 68 ga, which can be overcome by switching to fluorine-18 (18f) -based materials: a. the generation capacity of the generator is low and therefore limits the number of tests that can be performed at a given time. in contrast, 18f is produced in cyclotron. b. 68 ga has a short half-life of 68 minutes, which is a logical consequence of its availability to remote medical centers from the place of production, the time of the test and the patient's comfort, and the possibility of subsequent mappings. the half-life of 18f is 110 minutes. third. 18f has less energy than 68ga (0.65 mev vs. 1.9) and, as a result, a better maximum resolution that would potentially enable the demonstration of smaller lymph nodes involved in the disease. among the fluorine-18 (18f) materials selected for clinical application is 18f-psma-1007, both because the uptake is higher in the tumor than in the background, and because its removal is mainly the pathobiliary and only a small fraction of the material is released in the urine. this is another advantage of 18f-psma-1007 over 68ga-psma, potentially enabling a better demonstration of disease sites in the pelvis, without significant absorption of the bladder material. to date, accumulated promising experience, in germany, in imaging with 18f-psma-1007. in one published case, 17 degenerative disease sites were detected in one patient with biochemical failure 9 years after undergoing radical prostatectomy, which was not demonstrated by other imaging modalities, including ct, mri and bone mapping


Eligibility criteria:
inclusion criteria: 1. patients with prostate cancer, at moderate or high risk according to d'amico classification during the staging phase,and who have not received any treatment (gleason 7 and above and / or psa\> 10 and / or t2c or greater disease stage). 2. . patients who are treated in the department of urology at tel aviv medical center and who are undergoing radical prostatectomy, as a dependent treatment. exclusion criteria: 1. patients with another malignant disease. 2. patients under the age of 18 years.
dyadic text-messaging micro-intervention

Conditions: Advanced Cancer; Gastrointestinal Cancer

Summary: the purpose of this study is to develop, refine, and pilot test a text-messaging micro-intervention focused on improving communication skills for couples in which one partner has gastrointestinal cancer. for the pilot testing portion of the study, couples will be randomized (1:1) to receive the text-messaging communication micro-intervention or to a waitlist control group. all couples will be asked to complete questionnaires before randomization and 30 days post-randomization. couples in the waitlist control group will be offered the text-messaging micro-intervention after completing the second set of surveys (30-days post-randomization).

a cancer diagnosis requires patients and their intimate partners to communicate effectively to navigate illness-related challenges. research indicates that couples who use effective communication strategies have better individual psychological adjustment and higher relationship satisfaction. however, many couples have difficulty communicating about cancer-related issues which can lead to poorer individual, relationship, and patient health outcomes. while dyadic interventions to improve couple communication have proven efficacious, they are often time intensive and have limited reach. the challenges of recruiting couples into dyadic interventions are well-documented, with low recruitment rates especially among underserved couples. micro-interventions, which consist of brief educational materials and short activities delivered via text message or a mobile application, have significant potential to increase reach and participation in diverse groups of couples by increasing flexibility and reducing barriers to access. previous studies have found micro-interventions to be effective in promoting health behavior change in a wide range of individuals and in enhancing dyadic functioning in community couples. the proposed project aims to develop, test, and examine the feasibility, acceptability, and efficacy of a text-messaging communication micro-intervention for couples coping with advanced gi cancer.

Eligibility criteria:
inclusion criteria: 1. in a committed relationship 2. both members of the couple must read and speak fluent english 3. one partner must be diagnosed with advanced (stage iii or iv) gastrointestinal cancer and undergoing systemic therapy (e.g., chemotherapy) 4. one or both partners must score ≥1.0 on the holding back screen exclusion criteria: 1. patient or partner who is unable to provide informed consent as assessed by the oncologist or research staff 2. patient or partner is physically impaired in such a way that precludes the use of a mobile device 3. patient or partner who do not have a mobile device 4. patient or partner who is too sick to participate, as judged by the oncologist or research staff.

Keywords: cancer couples
a registry of sipuleucel-t therapy in men with advanced prostate cancer

Conditions: Advanced Prostate Cancer; Prostatic Neoplasms

Summary: the purpose of this study is to further quantify the risk of cerebrovascular events (cves) following sipuleucel-t (provenge®) therapy, and to follow all subjects for survival.

subjects will receive product as described in the sipuleucel-t approved label. the registry will be strictly observational and thus no additional clinical visits or laboratory tests will be conducted beyond normal clinical practice. investigators will be asked to record information that becomes available in the normal course of clinical management.

Eligibility criteria:
inclusion criteria: * subjects must be at least 18 years of age * subjects with advanced prostate cancer who will receive sipuleucel-t or who underwent their first leukapheresis for manufacture of sipuleucel-t ≤ 6 months prior to enrollment * subjects must understand and sign an informed consent form exclusion criteria: * none
jewel acl post market clinical follow up study

Conditions: Anterior Cruciate Ligament Injuries

Summary: the objective of the study is to assess re-rupture rates and patient outcomes from subjects with at least 5 year follow up, treated with the jewelacl device for acl reconstruction. the impact of fixation type and autograft augmentation will also be assessed. all adverse events related to the jewelacl device will be recorded. this study is sponsored by xiros.


Eligibility criteria:
inclusion criteria: * age more than 18 years * patients previously implanted with the jewelacl for anterior cruciate ligament (acl) reconstruction (primary jewelacl cases only, no revision cases) exclusion criteria: * age less than 18 years * any implantations for non-indicated conditions, as stated in the instructions for use instructions for use (ifu) * revision cases
a study to collect participants experience of living with adult upper limb (aul) spasticity and to assess the arm activity measure (arma)

Conditions: Spastic Hemiparesis; Muscle Spasticity

Summary: the participants of this study will have aul spasticity and have a need for botulinum toxin type a injections. aul spasticity is where people develop tightening or stiffness of the muscles in the arms. botulinum toxin type a is used for the treatment of spasticity in addition to physiotherapy. this study will ask participants to describe their experience living with aul spasticity. this information will be used to assess the arm activity measure (arma). arma is a scale designed to assess upper limb function in people with aul spasticity. this study could suggest changes to the arma to improve its suitability for people with aul spasticity or even the development of a new scale.


Eligibility criteria:
inclusion criteria : * participant has provided informed consent and is willing to take part in the study * participant is an adult aged at least 18 years * participant has a clinical diagnosis of spastic hemiparesis following stroke or traumatic brain injury (tbi) affecting one arm only * participant is at least 6 months post-stroke or tbi * participant has a need for botulinum toxin type a injections as part of their treatment for aul spasticity * patient is considered to be in a stable state with regard to their therapeutic interventions (i.e., all treatments for the patient's condition have been stable for at least one month prior to assessment of eligibility) * participant has access to the internet, laptop, or tablet, and is willing to take part in either an online focus group or interview (caregiver assistance is acceptable) * participant is fluent in the english language and is able to discuss their condition exclusion criteria : * participant has any medical condition that prohibits their ability to communicate with the interviewer including severe dysphasia or an inability to read questionnaires. * participant has any other clinically relevant concern (e.g., significant psychiatric disorder or depression, history of alcohol and/or drug abuse) that in your opinion would interfere with their ability to provide written informed consent and/or participate. * participant has aul spasticity is present in both arms
congenital malformations and maternal use of anti-hypertensive medication in the united kingdom

Conditions: Hypertension

Summary: assess fetal mortality and malformations in women treated with antihypertensive medication during preganancy. mother - child pairs will be analysed in a cohort selected from the uk in the cprd database. years covered are 1997 to 2014. aim is to assess the risk of antihypertensive treatment in women.

women with chronic hypertension are at risk of experiencing severe complications such as adverse effects of fetal growth, survival, and renal function during pregnancy. general recommendations advocate the treatment of high blood pressure during pregnancy to decrease these risks to the mother and child, with extreme caution. many studies assessing the risk of congenital malformations in infants whose mothers were treated with anti-hypertensive medication have been inconclusive, in part due to the variability of the original data sources and possibly the robustness of the analyses.2 studies regarding this health issue have been unable to stratify anti-hypertensive medications sufficiently to truly assess the risk per drug class, angiotensin ii receptor antagonists/blockers (arbs) and angiotensin-converting-enzyme inhibitor (ace inhibitor) in particular.we will attempt to assess the prescription rate of arbs and ace inhibitors among women with very high blood pressure in the united kingdom (uk) and estimate the risk of serious foetal outcomes in women treated with arbs and/or aces and who may also have the following co-morbid conditions: diabetes types i or ii, diabetic nephropathy, and congestive heart failure.

Eligibility criteria:
inclusion criteria: age and gender - exclusion criteria: -

Keywords: hypertension malformation fetal mortality