Kornimate/medical-research-clean huggingface dataset:
epidemiology of gallbladder sludge and stones in pregnancy

Conditions: Cholelithiasis

Summary: the specific objective of this project is to study the impact exercise has on gallstone formation during pregnancy when women are at increased risk due to biochemical and physiological alterations.

the female gender and multiparity are the two most important positive correlates of cholesterol gallstone disease. pregnancy represents the period of time when the 'lithogenic' pressure on a woman is the highest. biliary sludge is a precursor stage of gallstones. the investigators studied the etiological factors associated with the development of sludge and stones during pregnancy, and their early results suggest that it is inversely related to physical activity. they also found that being overweight, a known risk factor for gallstone disease, is associated with high blood leptin levels. in addition, the risk associated with high leptin levels is partially mitigated by physical activity. in order to disentangle the effects of physical activity, leptin and gestational diabetes on gallbladder disease risk, and to understand the mechanisms behind the observed associations, the investigators propose to conduct a randomized controlled trial. this interventional study is a logical extension of their previous observational investigation. their specific aims are: * to evaluate whether an endurance exercise program is associated with lower risk of gallbladder disease in overweight pregnant women; * to evaluate whether an endurance exercise intervention program changes leptin levels in pregnancy among overweight women; * to examine the associations between gallbladder disease incidence and potential causal variables in this prospective trial. these variables include leptin levels, hdl, insulin levels, bmi (as it varies within women classified as overweight), as well as changes in these variables. gallstone disease affects 15-20% of adult americans. cholecystectomy is one of the most commonly performed operations. the morbidity, and the burden of cost, incurred by gallstones are staggering. yet there is a dearth of understanding in the epidemiology and the cause of this disease. the results of this investigation should generate new, important and useful insights into the pathogenesis, and provide a rational strategy for the prevention, of this common and costly disease.

Eligibility criteria:
inclusion criteria: * pregnant * over 18 years of age * eligible for care at madigan army medical center exclusion criteria: * prior gallbladder surgery * non-english speaking * medical reason not to exercise during pregnancy * moving from area within 3 months

Keywords: physical activity cholelithiasis pregnancy complication
yttrium y 90 resin microspheres data collection in unresectable liver cancer: the resin study

Conditions: Localized Non-Resectable Adult Liver Carcinoma

Summary: this research registry studies yttrium y 90 resin microspheres in collecting data from patients with liver cancer not capable of being removed by surgery (unresectable) for the radiation-emitting selective internal radiation-spheres (sir-spheres) in non-resectable (resin) liver tumor registry. the information generated will help doctors better understand treatment patterns involving y90 therapy, gain additional insights in the long-term outcomes for patients, as well as guide future research for using y90 therapy, especially for those conditions where data is currently very limited or lacking.

primary objectives: i. the principal objective of the resin registry is to evaluate response to therapy using objective response criteria such as modified response evaluation criteria in solid tumors (mrecist) or european association for study of the liver (easl). the response criteria used will depend on tumor type treated and local policies as this is a registry and not a formal research study. secondary criteria include overall survival, time to progression (ttp) and toxicity. outline: patients receiving yttrium y90 resin microspheres treatment as part of their overall oncologic management are added in the resin registry database to collect and document information including: patient demographics (gender/age), previous oncologic treatments, details of yttrium y90 resin microspheres treatment, and to track outcomes and complications.

Eligibility criteria:
inclusion criteria: * patients receiving sir-spheres therapy to the liver for the first time. * provision of written informed consent. * age 18 and older. exclusion criteria: 1. prior completion of y90 therapy to the liver (sir-spheres, theraspheres, or any other liver-targeted therapy involving the use of radiation-emitting spheres). -patients who have received y90 treatment in the past and who are returning for another y90 treatment are ineligible, even if new areas are being targeted. 2. need for surrogate consent. patients unable to consent on their own behalves are not eligible for this study.

Keywords: hepatocellular carcinoma colorectal cancer neuroendocrine tumor cholangiocarcinoma breast cancer tumor of unknown primary pancreatic cancer
clinical outcomes, graft longevity, and chondral protection following primary or revision meniscal allograft transplantation surgery

Conditions: Meniscus Tear; Meniscus Disorder; Patient Satisfaction

Summary: the mercure (meniscus, restoration, conservation, and repair) group is embarking on a 20-year follow-up study to evaluate the clinical outcomes, graft longevity, and chondral protection following primary or revision meniscal allograft transplantation surgery this clinical investigation is a prospective, primary observational, open-label, non-randomized, multi-center study. it is designed to collect clinical follow-up data on patients


Eligibility criteria:
inclusion criteria: subjects enrolled in this study must meet all of the following inclusion criteria: * males and females aged 10-65 years * mri or arthroscopic images confirming the suitability for meniscus transplantation. * patients undergoing an isolated primary/revision mat (meniscal allograft transplant) procedure, or concomitant mat with other knee procedures such as ligament reconstruction, realignment osteotomy, or cartilage resurfacing. * medically suitable for meniscus transplantation. * appropriate understanding of the language of the surgical center in terms of communication and reading. * ability of the patient or parent/guardian to provide informed consent. exclusion criteria: * inability to comply with rehabilitation programs. * patient aged less than 10 years and more than 65. * presence of diffuse full thickness cartilage loss (widespread icrs grade iii-iv chondral damage) and/or architectural remodeling of bone (i.e. flattening of condyle) in the knee of interest. * significant medical comorbidities that limit patients from undergoing surgery. * presence of confounding neuromuscular, genetic/congenital, or post-traumatic conditions.

Keywords: meniscal allograft transplant
evaluation of bicros fitting benefits

Conditions: Unilateral Deafness

Summary: 22 candidates for bicros hearing aids will be recruited and fitted with a hearing aid and a cros device. following a real-world trial, each participant will be tested on a range of outcome measures including speech recognition in noise, ratings of listening effort, and ratings of preference.

unilateral hearing loss (uhl) can be defined as any degree of permanent hearing loss on one ear with normal hearing in the opposite ear. unilateral hearing loss can be debilitating associated with audiological, psychosocial and educational challenges. audiological challenges include the reduced ability to localize sounds, reduced awareness on the unaidable side and difficulties hearing in noise or at a distance. one solution for unaidable uhl is contralateral routing of signals (cros) and bilateral contralateral routing of signals (bicros) using a so-called cros transmitter together with a hearing aid. the rationale for this clinical investigation is to collect clinical data with a rechargeable cros transmitter to evaluate the benefits of a bicros fitting compared to the alternative treatment option, the monaural hearing aid fitting, and to no treatment in noisy listening situations. hearing tests, ear impressions and hearing aid fitting visits are mainly conducted at the national centre for audiology in london, ontario. those visits are available at the sonova innovation centre toronto in mississauga, ontario, upon request. outcome measurements are only conducted at the national centre for audiology in london, ontario.

Eligibility criteria:
inclusion criteria: * unaidable hearing loss in worse ear (\>n6) * aidable hearing loss (n3 to n5) on the other ear * fluent english speaker exclusion criteria: - aidable hearing loss in both ears
multicentric registry for the detection of c5 palsy after anterior cervical discectomy and fusion

Conditions: Degenerative Cervical Spinal Stenosis; Cervical Disc Herniation; Suspected Cervical Spine Instability

Summary: detect the reason for the frequently occurring c5 palsy after anterior cervical discectomy and fusion

a registry which includes all known and individually analyzed but even new factors are evaluated in order to perform a multivariate analysis for the detection of risk factors of c5 palsy after anterior cervical discectomy and fusion which is a very disabling and still cryptic complication.

Eligibility criteria:
inclusion criteria: * acdf or cervical vertebral body replacement due to herniated disc, spinal stenosis or trauma exclusion criteria: * infectious disease or neurodegenerative disease
randomized study on the effects of moderate anaemia in free microvascular tissue transfer

Conditions: Open Fracture of Foot; Tumor

Summary: the evaluation of perfusion of free flaps in patients with moderate anaemia and possible reduction of the transfusion threshold. * trial with surgical intervention

in study group 1 patients will be kept at a hematocrit level below 28% and only receive transfusions if symptomatic or the fall below 25%. patients in group 2 will receive transfusions to reach a hematocrit always above 30%. tissue perfusion in free flaps will be measured with indocyanine green fluorescence angiography, confocal microscopy and oxygen partial pressure measurement probes.

Eligibility criteria:
inclusion criteria: * planned defect reconstruction with free flap and preoperative hematocrit of 28% or below exclusion criteria: * coagulation disorder * jehovah's witness * iodine allergy * renal or hepatic insufficiency
optimizing timolol maleate treatment of infantile hemangioma by doppler ultrasound examination

Conditions: Infantile Hemangioma

Summary: the purpose of this study is to assess the safety and efficacy of timolol maleate treatment for different depth of infantile hemangioma based on b-ultrasonography. based on the depth of hemangioma, patients will be proactively allocated to two groups. and then, all patients in both groups will receive topical timolol treatment in the same protocol and dosage.

primary: describe the efficacy of 0.5% topical timolol maleate drops in different depth of infantile hemangioma as assessed through ib-ultrasound.

Eligibility criteria:
inclusion criteria: * infants of 0 to 6 months of age * skin infantile hemangiomas (ihs) in the proliferation stage without prior treatment * ihs with a surface area of less than 1% of body surface area * skin type iii/iv exclusion criteria: * ulcerated ihs. * unsuitable for topical timolol treatment due to anatomical location of lesion, eg. periorbital and lip ihs. * patients with severe systemic or congenital disease which may affect the patient's safety in this study

Keywords: timolol maleate doppler ultrasound examination
dynamic monitoring and characterization of pelvic by 3d ultrafast mri

Conditions: Pelvic Deformity

Summary: pelvic floor disorders affect a large population of women and are responsible for a significant impairment in their quality of life, but the pathophysiology of these disorders is still poorly understood. the project proposes to define new ultra-fast 3d mri sequences to capture the movements of the main pelvic organs. visualization of 3d volumes is of great importance to clinicians, but data size hinders clinical use. this study is the first to propose a dynamic 3d representation of pelvic organs, together with quantitative estimates of the deformations undergone. the method is based on four steps: dynamic acquisition, organ segmentation, temporal reconstruction, quantification and visualization of deformations. the d3-pelvis project responds to the challenge of "technologies for health" with dynamic 3d mri acquisition and 3d modeling, offering prospects for diagnostic aids and simulators.


Eligibility criteria:
inclusion criteria: * adult women, +/- of childbearing age, with or without effective contraception. * informed consent signed prior to any procedure described in the study. exclusion criteria: * contraindication to mri, * impossibility of performing the examination during thrust, * minor patients * pregnant or breast-feeding women, * women of legal age under guardianship * persons staying in a health or social institution, * people in emergency situations, * persons not covered by a social security scheme, * persons deprived of their liberty. * specifically, women with iuds will be excluded if they cannot remove them before the examination. * for healthy volunteers: history of colorectal surgery.
a multicenter, open-label study to investigate the safety and pharmacokinetics of lacosamide in children with partial seizures

Conditions: Epilepsy

Summary: the purpose of this study was to evaluate the safety and pharmacokinetics of lcm syrup in children ages from 1 month to 17 years with uncontrolled partial seizures when added to 1 to 3 other antiepileptic drugs (aeds).

six subjects aged 5-11 (cohort 1) were initially enrolled at the 8 mg/kg/day dose level. upon completion of the study for these subjects, pharmacokinetic and safety data were analyzed to determine the target dose for the remaining subjects (either 8, 10 or 12 mg/kg/day). depending on the selected target dose, four additional age-based cohorts of subjects were to be enrolled. lcm was increased 2 mg/kg/day per week until the target dose or maximum dose able to be tolerated was achieved.

Eligibility criteria:
inclusion criteria: * subject is male or female between 1 month and 17 years of age inclusive * subject's body mass index (bmi) is within the 5th to 95th percentile for his/her age group * subject has a diagnosis of epilepsy with partial-onset seizures * subject has been observed to have uncontrolled partial-onset seizures after an adequate course of treatment with at least 2 anti-epileptic drugs (aeds) (concurrently or sequentially) * subject has been observed to have at least 2 countable seizures in the 4-week period prior to screening * subject is on a stable dosage regimen of 1 to 3 aeds exclusion criteria: * subject is currently participating or has participated within the last 2 months in any study of an investigational drug or experimental device * subject with seizures that are uncountable due to clustering during the 8-week period prior to study entry * subject is on a ketogenic or other specialized diet * subject has a history of primary generalized epilepsy * subject has a history of status epilepticus within the 6-month period prior to screening * subject is receiving concomitant treatment with felbamate or has received previous felbamate therapy within the last 6 months prior to screening * subject has taken or is currently taking vigabatrin * subject is taking monoamine oxidase (mao) inhibitors or narcotic analgesics * subject has a lifetime history of suicide attempt, or has suicidal ideation in the past 6 months

Keywords: lacosamide vimpat children epilepsy seizures anti-epileptic
community-based adolescent diabetes prevention program

Conditions: Pre-Diabetes

Summary: the number of youth with type 2 diabetes is predicted to quadruple by 2050, with a disproportionate increase among minority youth. the research proposed in this career development award will use community-based participatory research methodology as well as novel strategies (peer education and mobile health technologies) to design, implement and evaluate a diabetes prevention intervention for at-risk ethnic minority youth in an urban community with high disease burden.

approach: the proposed research addresses diabetes risk and prevention among racial/ethnic minority adolescents in east harlem (eh), ny. aim 1 will use qualitative methods to explore the best strategies for using peer education for diabetes risk reduction in youth and the potential role of mobile health technologies in improving adherence to behavioral modification plans. aim 2 will utilize findings from preliminary studies and aim 1 to design and evaluate a pilot community-based intervention to 1) maintain/reduce bmi (primary outcome), 2) improve adolescent dietary, physical activity and weight control behaviors, and 3) improve other measures of diabetes risk. data will be collected at baseline, immediately after the intervention (3 months) and at one year in the intervention and wait list control groups. aim 3 involves refining the pilot intervention based on an examination of intervention feasibility, acceptability, and sustainability and planning for a future r01.

Eligibility criteria:
inclusion criteria for pre-diabetes screening: * adolescents ages 13-19 years of age * english speaking * residents of east harlem or members of an east harlem institution. membership in an east harlem institution includes the following: 1. attending a school in east harlem 2. attending an after school or recreational activity in east harlem 3. receiving health care in east harlem proof of address or membership in an east harlem institution will not be asked. * at risk for diabetes (overweight/obese based on measured bmi percentile and with either a parent or grandparent with type 2 diabetes) * no plans to relocate from new york city in the next year note: additional inclusion criteria for participation in workshops include diagnosis of pre-diabetes based on oral glucose tolerance test exclusion criteria for pre-diabetes screening: * \ 19 years of age * previous diagnosis of diabetes * bmi percentile \<85th percentile for age and gender based on centers for disease control and prevention definition * currently pregnant * speaking a language other than english * on medications that may raise or lower blood sugar * plans to relocate from new york city within one year of enrollment- note: additional exclusion criteria for participation in workshops include fingerstick glucoses outside the pre-diabetes range during oral glucose tolerance testing and any cognitive or physical impairment that would preclude comprehension of the group educational program

Keywords: community-based participatory research adolescents
protein and ultrasound indicators of preterm birth

Conditions: Preterm Birth

Summary: women are being asked to participate in a research study that is looking for new methods to understand and predict premature birth (birth before 37 weeks of pregnancy-full term pregnancy is 40 weeks). in this study the investigators will be looking at proteins in vaginal fluid, tissue from the placenta after the baby is born (fetal membranes), and a new form of ultrasound of the mouth of the womb (cervix) that measures its length, volume, and stiffness, in order to try to know who will have a preterm birth and who will reach full term. the investigators will collect the vaginal fluid samples and perform ultrasounds both in the clinic throughout pregnancy in normal women, and from women admitted to the hospital because they are in early labor. the investigators will collect the placental tissue after the baby is born (this is normally discarded). this study will help us to understand the process of preterm birth and the investigators hope that this will eventually allow us to develop better methods to treat preterm labor and prevent the birth of premature babies.


Eligibility criteria:
inclusion criteria: * single live intrauterine pregnancy * good gestational age dating exclusion criteria: * history of prior cervical procedure such as leep, ckc, or cryotherapy * maternal or fetal indication for preterm delivery * cerclage in place
south china children cancer group - relapsed-acute lymphoblastic leukemia 2022 protocol

Conditions: Arsenic Trioxide; Childhood ALL

Summary: in recent years, the prognosis of pediatric relapsed all patients has improved, but the 5-year os of patients with first recurrence is still less than 50%. a number of in vitro studies have shown that arsenic trioxide (ato) can selectively inhibit the growth and induce apoptosis in a variety of leukemia cell lines, suggesting that ato as a synergist combined with other common chemotherapy drugs may provide a new target for the treatment of relapsed all. realgar indigo naturalis formula is a compound traditional chinese medicine preparation developed in china. the main component of realgar is arsenic tetrasulfide (as4s4), which can produce similar pharmacological effects to ato. based on the r3 protocol, this study plans to perform a double-blind randomized controlled trial, and to randomly combine compound huangdai tablets with compound huangdai tablets in the treatment of intermediate and high risk all children, in order to improve the mrd negative rate after induction therapy in this group of children, which may provide a new method for the clinical treatment of relapsed all.

in recent years, the prognosis of pediatric relapsed all patients has improved, but the 5-year os of patients with first recurrence is still less than 50%, and the prognosis of children with intermediate and high risk is even worse, so there is an urgent need to explore new and effective treatment methods. a number of in vitro studies have shown that arsenic trioxide (ato), which is safe and effective in the treatment of apl, can selectively inhibit the growth and induce apoptosis in a variety of leukemia cell lines, suggesting that ato as a synergist combined with other common chemotherapy drugs may provide a new target for the treatment of relapsed all. realgar indigo naturalis formula is a compound traditional chinese medicine preparation developed in china. the main component of realgar is arsenic tetrasulfide (as4s4), which can produce similar pharmacological effects to ato. the uk all r3 protocol is an advanced and mature clinical trial. the results showed that the mrd negative rate after induction chemotherapy and the 2-year dfs of traditional chemotherapy ±hsct in children with intermediate and high risk did not reach 50%. based on the r3 protocol, this study plans to perform a double-blind randomized controlled trial, and to randomly combine compound huangdai tablets with compound huangdai tablets in the treatment of intermediate and high risk all children, in order to improve the mrd negative rate after induction therapy in this group of children, which may provide a new method for the clinical treatment of relapsed all.

Eligibility criteria:
inclusion criteria: * b or t cell type; * the first recurrence; * the risk stratification was medium or high risk. exclusion criteria: * mature b cell leukemia; * acute mixed phenotype leukemia; * patients with positive bcr/abl fusion gene; * the second tumor * definite cml blast crisis; * all with down's syndrome.