Kornimate/medical-research-clean huggingface dataset:
postoperative radiotherapy in thoracic esophageal squamous cell carcinoma with neoadjuvant chemoradiotherapy

Conditions: Radiation Oncology

Summary: the primary objective is to compare surgery with postoperative radiotherapy (port) versus surgery, in terms of the overall survival time (os) in stage ii or iii squamous cell esophageal carcinoma with neoadjuvant chemoradiotherapy(ncrt).

esophageal squamous cell carcinoma (escc) is a common type of esophageal carcinoma in china, which is characterized by rapid development and fatal prognosis in most patients. neoadjuvant chemoradiotherapy (ncrt) has been explored for many years in western countries and japan, and proved to get survival benefit, especially for locally advanced esophageal cancer. however, the recurrence is the major cause of treatment failure in patients with escc. our hypothesis is that inadequate radiation dose leads to recurrence of escc with ncrt and port lower recurrence rate and improved os. as is known, there are no any studies concentrating on port in escc with ncrt. patients are randomly assigned to port (group a) or without port (group b) with a 1:1 allocation ratio. the primary outcome is os assessed with a minimum follow-up of 60 months. secondary outcomes are progression-free survival (pfs), recurrence-free survival (rfs).

Eligibility criteria:
inclusion criteria: 1. patients must not have received any prior anticancer therapy histologically-confirmed squamous cell carcinoma of the esophagus; 2. tumors of the esophagus are located in the thoracic cavity; 3. pre-treatment stageⅱ-ⅲ (ajcc/uicc 8th edition) 4. male or non pregnant female 5. age is between 18 years and 65 years, 6. eastern cooperative oncology group (ecog) performance status 0-1 or karnofsky performance status (kps) of 70 or more; 7. adequate bone marrow function (white blood cells ≥4x109 /l; neutrophil ≥1.5×109 /l; hemoglobin≥ 90 g/l; platelets≥100x109 /l); 8. adequate liver function (total bilirubin, aspartate transaminase(ast) and alanine transaminase (alt) ≤2x upper level of normal (uln)); 9. adequate renal function (serum creatinine (scr) ≤1.5 x uln); 10. the patient has provided written informed consent and is able to understand and comply with the study. exclusion criteria: 1. patients with non-squamous cell carcinoma histology; 2. patients with advanced inoperable or metastatic esophageal cancer; 3. patients with another previous or current malignant disease； 4. any patient with a significant medical condition which is thought unlikely to tolerate the therapies. such as cardiac disease; 5. age \>65 years; 6. pregnant or lactating female or people during the birth-period who refused to take contraceptives; 7. uncontrolled seizures or psychiatric diseases, loss of control over their own behavior; 8. patients who refuse surgery after neoadjuvant chemotherapy; 9. unsuitable to be enrolled in the trial in the opinion of the investigators
tocotrienol as a nutritional supplement in patients with advanced lung cancer

Conditions: Lung Cancer

Summary: there is a need for improving the effect of first-line chemotherapy for lung cancer patients, preferably by using an approach with none or very few side effects. in this trial the investigators incorporate δ-tocotrienol/placebo as a nutritional supplement on top of standard chemotherapy for patients with advanced non-small cell lung cancer.


Eligibility criteria:
inclusion criteria: * histologically confirmed non-small cell lung cancer, including squamous cell carcinomas, adenocarcinomas and non-neuroendocrine large cell carcinomas * patients with advanced stages of nsclc who are candidates to first-line platinum-based doublet chemotherapy * measurable disease by recist 1.1 * age ≥ 18 years. * performance status 0-2. * adequate bone marrow function, liver function, and renal function (within 7 days prior to inclusion): * white blood cells (wbc) ≥ 3.0 \* 10\^9/l or neutrophils (anc) ≥ 1.5 \* 10\^9/l * platelet count ≥ 100 \* 10\^9/l * hemoglobin ≥ 6 mmol/l * serum bilirubin \< 2.0 \* upper level of normal (uln) * serum transaminase ≤ 2.5 \* uln * serum creatinine ≤ 1.5 uln * written and orally informed consent. exclusion criteria: * other malignant diseases within 5 years prior to inclusion in the study, except curatively treated basal cell or squamous cell carcinoma of the skin and other types of cancer with minimal risk of recurrence. * other experimental therapy or participation in another clinical trial within 28 days prior to treatment initiation. * patients who have received prior chemotherapy for nsclc * patients with nsclc who are candidates to neoadjuvant chemotherapy or curative chemoradiotherapy * underlying disease not adequately treated (diabetes, cardiac disease) * allergy to the active substance or any of the auxiliary agents * pregnant or breast-feeding patients. for fertile women a negative pregnancy test at screening is mandatory. * fertile patients not willing to use effective methods of contraception during treatment and for 6 months after the end of treatment.
how orally consumed 3-hydroxybuturate alters metabolism

Conditions: Acute Ketosis

Summary: this study evaluate the metabolic effects of orally ingested ketone bodies. the study is conducted as a randomized, cross over study.

subject participate for two separate days; i) intervention, ii) placebo. intervention: subjects drink ketone body solution. tracer kinetics on glucose and lipid metabolism is applied. muscle tissue and adipose tissue biopsies are taken. placebo: subjects drink saline. same sampling as on intervention day.

Eligibility criteria:
inclusion criteria: * bmi 20-30 exclusion criteria: * smoking * alcohol or drug abuse * critically ill
the effect of in-utero exposure to metformin in 5-11 year old offspring of mothers in the mity trial

Conditions: Diabetes Mellitus, Type 2; Pregnancy in Diabetic; Child Obesity; Child Development

Summary: the incidence of diabetes in pregnancy is rising, with rates of 1 in 7 pregnancies globally. metformin is used for type 2 diabetes (t2dm) outside of pregnancy and is now increasingly prescribed during pregnancy. there are some concerns as metformin crosses the placenta and effects on offspring exposed during pregnancy are unknown. animal and human evidence indicate that metformin may create an atypical in-utero environment similar to under-nutrition which has been associated with adult obesity. this is supported by studies in children of mothers treated with metformin in other populations where an increase in childhood obesity was found at 4-9 years of age. we now have evidence from the mity trial, that offspring of metformin-exposed women with t2dm have less large infants and are less adipose at birth, but are also more likely to be small for gestational age (sga). these effects could lead to benefit or harm in the long-term. offspring of mity mothers are currently being followed up to 2 years. given that long-term effects may not be evident until 5 years of age, it is imperative to follow these children longer. goals/research aims:to determine whether in-utero exposure to metformin, in offspring of women with t2dm, is beneficial or harmful in the long-term. research questions: 1. in offspring of women with t2dm, how does treatment with metformin during pregnancy affect a) adiposity b) growth over time c) metabolic syndrome d) cognitive and behavioral measures:2. what factors predict altered childhood adiposity and insulin resistance in these offspring? primary outcome: body mass index (bmi) z-score. secondary outcomes: 1) other measures of adiposity (i.e. skinfolds, 2) growth over time 3) measures of insulin resistance 4) adipocytokines 5)neurodevelopment expected outcomes given these increasing concerns, this study will inform the best treatment for pregnant mothers with diabetes by studying the long-term outcomes of children exposed to metformin during pregnancy.


Eligibility criteria:
inclusion criteria: * liveborn offspring of women who participated in the mity trial. exclusion criteria: * offspring with major congenital anomalies that would affect growth or development (these children have already been excluded from mity kids).
effect of multi-media tool on enrollment in oncology clinical trials

Conditions: Lung Cancer; Gastric Cancer; Pancreatic Cancer

Summary: the purpose of this research study is to test a touchscreen computer program, which allows patients to see information on a computer screen regarding cancer care, and specifically clinical trials. the purpose of this research is to help the investigators learn more about how to use technology in the medical setting to improve health outcomes.

enrollment in therapeutic cancer trials remains low, and is especially challenging for patients with low health literacy. the purpose of this project is to pilot a multi-media technology intervention designed for patients with diverse health literacy skills with the aim of improving patient receptiveness, willingness, knowledge, self-efficacy, and positive attitudes regarding clinical trials. the intervention is comprised of multi-media touchscreen computer program components for clinical trial education and assessment of patient-reported outcomes. patients presenting for their first oncology appointment were eligible. patients viewed an interactive teaching video concerning clinical trials that was adapted from the national institutes of health. validated surveys assessing receptiveness, willingness, knowledge, self-efficacy, and positive attitudes regarding clinical trials were administered before and after the test.

Eligibility criteria:
inclusion criteria: * adult, english-speaking women and men * newly diagnosed with lung, gastric or pancreatic cancer * coming to the university of chicago outpatient oncology clinics for their first oncology visit there are no exclusion criteria.

Keywords: clinical trials enrollment communication low health literacy health disparities
effect of oxygen on core temperature

Conditions: Cardiac Disease; Cheyne-Stokes Respiration

Summary: study of the effect of oxygen on the frequency of central apnea, sleep and body temperature in patients with a cardiac disease


Eligibility criteria:
inclusion criteria: * cardiac disease and cheyne-stokes respiration and controls without cheyne-stokes respiration exclusion criteria: * obstructive sleep apnea
influence of hospital volume on mortality and length of hospital stay after oesophageal cancer resection in switzerland

Conditions: Esophageal Cancer

Summary: the effect of centralisation measures on the operative outcomes after oesophageal cancer resection (ecr) in switzerland has not been highlighted yet. oesophageal cancer is a rare malignancy in switzerland. it accounts for 2% of all cancers, with an incidence of 603 per year between 2017 and 2021, affecting primarily men (incidence per year 445, 74%). the mortality of oesophageal cancer is high. the 437 annual oesophageal cancer-related deaths between 2017 and 2021 result in a low 5-year overall survival (os) of only 30%. together with the often polymorbid patients, the very demanding surgical technique, and the challenges in postoperative management, a specialised, high-volume, interdisciplinary treatment team is required. the centralisation of such complex surgical procedures in specialised centres aims to build up such treatment teams, resulting in improved quality of the treatment and increased patient safety. to concentrate such procedures in switzerland, the "intercantonal agreement on highly specialized medicine" came into force in 2009. in 2013, esophagectomy was regulated for the first time, and the first service allocations were awarded definitely to eight and provisionally to another eight swiss centres. before 2013, esophagectomy was performed in 69 hospitals in switzerland. the decision on the allocation was revised in 2019, resulting in only eight swiss centres remaining with a service contract for esophagectomy. the next review will take place on the 31st of july 2025. this retrospective registry study provides swiss national data on the effect of centralisation on operative outcomes after oesophageal cancer resection (ecr) in switzerland. it aims to measure the influence of the hospital-specific case number of ecr per year (hospital volume) on the outcome.


Eligibility criteria:
inclusion criteria: * esophageal cancer resection exclusion criteria: * incomplete documentation * age under 20 years * other hospitals than general or surgical hospitals * no index operation
effects of aromatase inhibitor therapy on muscle function

Conditions: Breast Cancer; Breast Cancer Female

Summary: this is a pilot study designed to examine changes in muscle function after aromatase inhibitor (ai) therapy, at both the molecular and clinical level.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. post-menopausal 3. diagnosis of ductal carcinoma in situ (dcis) or stage i, ii, or iii er positive breast cancer 4. plan to initiate an ai per treating physician. 5. completion of all primary therapy for breast cancer, including surgery, radiation, and chemotherapy (should be completed 14 days or more prior to obtaining the baseline muscle biopsy). ongoing her2 targeted therapy with trastuzumab and/or pertuzumab is allowed. ongoing neratinib therapy is not allowed. 6. body weight less than 350 lbs., as dictated by the weight limit for dxa (dual energy x-ray absorptiometry) scanner 7. must be willing to undergo muscle biopsy at baseline and after 24 weeks of ai therapy 8. eastern cooperative oncology group (ecog) performance status of 0-1 at the time of study enrollment 9. informed consent and authorization of the release of health information must be obtained according to institutional guidelines exclusion criteria: 1. unwilling to co-enroll into the fit core study 2. diagnosis of severe osteopenia or osteoporosis, defined as a bone mineral density of ≥ 2.0 standard deviations below the young adult female reference mean (t score) 3. diagnosis of other disorder affecting bone function or turnover, such as paget's disease, renal osteodystrophy, parathyroid disorders, or vitamin d deficiency/osteomalacia 4. prior history of non-traumatic, fragility bone fracture 5. any muscle or neuromuscular disorder affecting muscle function, such as muscular dystrophy, myositis, or amyotrophic lateral sclerosis 6. any condition precluding power protocol participation (i.e. exertion on a stationary bicycle), including: new york heart association (nyha) class iii or iv congestive heart failure, uncontrolled angina, myocardial infarction in the prior 12 months, orthopedic surgery in the previous 6 months or plans for orthopedic surgery during the study period, chronic uncontrolled pulmonary conditions such as uncontrolled asthma (symptoms \> 2 days/week) or dyspnea requiring oxygen, symptomatic peripheral vascular disease, or any other comorbidity that would interfere with the ability to complete and comply with the protocol in the opinion of the investigator 7. need for daily anticoagulation use 8. allergy to local anesthetic 9. locally recurrent or metastatic breast cancer a. history of prior treated malignancies, other than breast cancer, that are now stable, are in remission, and do not require active therapy, are acceptable.

Keywords: post menopausal er positive aromatase inhibitor therapy breast cancer
rasburicase (fasturtec) registration trial

Conditions: Hyperuricemia

Summary: primary: to compare the efficacy of rasburicase versus allopurinol in controlling tumor lysis-related hyperuricemia in chinese patients with leukemia or lymphoma. secondary: to compare the efficacy and safety of rasburicase versus allopurinol in chinese patients stratified according to disease (leukemia or lymphoma ).


Eligibility criteria:
inclusion criteria: * at high risk of malignancy and/or chemotherapy-induced hyperuricemia * performance status less than 3 on ecog scale or more than 30% kps scale * uric acid concentrations ≥ 8.0mg/dl * suffering from non-hodgkin's lymphoma stage more than iii, or acute lymphoblastic leukemia with peripheral with blood cell count more than 25,000/mm3, or any lymphoma or leukemia exclusion criteria: * treatment with an investigational drug at any time during the 14-day study period (except for agents that are permitted by the sponsor) * pregnancy or lactation * prior treatment with uricozyme or rasburicase * scheduled to receive asparaginase either 24 hours after the first dose of rasburicase * treatment with allopurinol within the seven days preceding study day 1 * history of significant atopic allergy problems or documented history of asthma * history of severe reaction to allopurinol * known history of glucose-6-phosphate dehydrogenase deficiency. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
effect of a multistrain probiotic on allergic rhinitis symptoms and gut microbiota composition in atopic patients

Conditions: Allergic Rhinitis

Summary: the purpose of the current study is to evaluate the efficacy of administering a multistrain probiotic in adult human subjects suffering from allergic rhinitis and evaluate both symptomatology through validated questionnaires and gut microbiota modification during and after treatment.

adult subjects (18-60) with documented allergic rhinitis will be assigned to placebo or probiotic groups and take either placebo or probiotic dietary intervention for 8 weeks. total nasal symptom score (tnss), rhinitis control assessment test (rcat), mini rhinoconjunctivitis quality of life questionnaire (minirqlq) will be compared over 12 weeks between the two treatment groups. in addition, serological markers (eosinophil count, total ige and eosinophilic cationic protein) and gut microbiota features will be evaluated over a 12 week period.

Eligibility criteria:
inclusion criteria: * adults aged 18 to 65 years of age * established allergic rhinitis (clinical history of rhinorrhea, congestion, sneezing, pruritis \>2 years) * positive skin prick test and/or specific ige to at least one aeroallergen. * have signed the consent form * have been instructed during screening and agreed to not take any probiotic containing products outside the study for the study period exclusion criteria: * subjects currently under treatment with antibiotics * subjects undergoing allergen immunotherapy * pregnancy * vasomotor rhinitis * nasal cavity disorders * ear infections * other chronic diseases (e.g. gastrointestinal, cardiovascular, infections) * subjects diagnosed with non-controlled asthma * subjects currently participating in another interventional clinical trial or having participated in another clinical trial in the last 2 months * subjects on chronic use of systemic corticosteroids * proton pump inhibitors 2-weeks prior to randomization * antibiotics 2-weeks prior to randomization

Keywords: microbiota
prevalence of mih in young adults at cairo university dental hospital and its link to dental cavities: a cross-sectional study

Conditions: Molar Incisor Hypomineralization; Dental Caries

Summary: we are conducting a study to understand how often mih (molar incisor hypomineralization) occurs and whether it is linked to a higher chance of dental cavities (caries). mih is a condition where the enamel (the hard outer surface) of the first permanent molars and incisors (front teeth) doesn't develop properly, making these teeth more prone to damage and decay. we are looking at whether patients with mih have more cavities in their teeth compared to patients without mih. this study aims to help us learn more about the connection between mih and dental health, so we can improve care and prevention strategies for kids at risk of cavities.


Eligibility criteria:
inclusion criteria: * patients whose age between 18 and 30 years old provide informed consent egyptian patients from both sexes exclusion criteria: * patients under or over this age group patients undergoing orthodontic treatment patients who refuse to participate

Keywords: mih
efficacy and safety of tran cannula in combined pseudoexfoliative glaucoma and cataract surgery compared with augmented ocular irrigation

Conditions: Glaucoma, Open Angle, Pseudo-exfoliative; Cataract

Summary: pseudoexfoliative glaucoma is a glaucoma secondary to pseudoexfoliative syndrome; cataract surgery is often more difficult, with more complications. tran's cannula is a single-use irrigation system designed for cleaning, with the pseudoexfoliative material remaining in the trabecular meshwork. the main objective of this study is to evaluate the efficacy of the tran cannula, in comparison with increased irrigation, in lowering intraocular pressure (iop) in patients with pseudoexfoliative glaucoma and treated for glaucoma, and with an indication for isolated cataract surgery.


Eligibility criteria:
inclusion criteria: * patients with cataract and early-to-moderate pseudoexfoliative glaucoma (gpx) scheduled for isolated cataract surgery. * reliable visual field, humphrey 24-2, sita-fast, with typical glaucoma alterations, and with mean deviation ≤-12 db. * oct with ganglion cell alterations and fibers typical of glaucoma. * typical glaucomatous neuropathy * slit-lamp signs of pseudoexfoliation. * open angle (2 to 4, according to shaffer classification) determined by gonioscopy. * untreated eye pressure \>21 mmhg and \<33 mmhg exclusion criteria: * presence of other ophthalmological pathologies (except cataract or mild dry eye) * history of intraocular surgery in the last 12 months, history of trauma * history of laser trabeculoplasty (tla or slt) in the previous 12 months * visual acuity below "finger count * myopia ≥ 6 dioptres, hyperopia ≥ 5 dioptres * iridocorneal angle closure (and angle-closure glaucoma), any other type of non-pseudoexfoliative glaucoma, iris neovascularization * pachymetry \ 620 μm; or corneal pathology or other condition that makes accurate iop measurements with flattening tonometry, ultrasonic pachymetry or specular microscopy impossible. * presence of severe systemic pathologies
study of regn1500 in participants with homozygous familial hypercholesterolemia (hofh)

Conditions: Homozygous Familial Hypercholesterolemia

Summary: this is an open-label, single-arm study to assess the reduction of low-density lipoprotein cholesterol (ldl-c) by regn1500 in patients with homozygous familial hypercholesterolemia (hofh).


Eligibility criteria:
inclusion criteria: 1. men and women ≥18 years of age at the time of the screening visit 2. diagnosis of homozygous familial hypercholesterolemia (hofh) 3. willing to consistently maintain usual diet for the duration of the study exclusion criteria: 1. background medical lipid modifying therapy that has not been stable for at least 4 weeks (6 weeks for fibrates) prior to the screening visit 2. having undergone lipid apheresis within 4 weeks prior to the screening visit 3. use of another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer) prior to the screening visit 4. previous participation in any clinical trial of regn1500 note: the information listed above is not intended to contain all considerations relevant to a patient's potential participation in this clinical trial therefore not all inclusion/ exclusion criteria are listed.
fosamprenavir expanded access

Conditions: Infection, Human Immunodeficiency Virus

Summary: this open-label study will enable hiv-infected adults with limited treatment options to receive fosamprenavir until commercial supplies are available in switzerland.


Eligibility criteria:
inclusion criteria: * hiv-1 infected subjects. * subjects must belong to one of the following populations: 1. subjects with limited treatment options due to viral resistance, interactions, or tolerability issues with other antiretroviral drugs. 2. subjects who already receive amprenavir (agenerase®) 3. subjects for whom once daily dosing of antiretroviral therapy is indicated, including, once daily dosing with fosamprenavir/ritonavir.

Keywords: protease inhibitor treatment experienced amprenavir fosamprenavir gw433908 hiv pro drug