Kornimate/medical-research-clean huggingface dataset:
weight loss management in endometrial cancer survivors

Conditions: Endometrial Cancer Survivors; Weight Management; Early Stage Endometrial Cancer

Summary: this study is being done to understand how oncologists can engage a multidisciplinary team to help endometrial cancer survivors with obesity to engage in a weight management program and potentially start a weight loss medication. obesity often impacts the future health and longevity of early-stage endometrial cancer survivors more than their cancer diagnosis. patients will be referred to the kumc ob/gyn weight management clinic to discuss weight management options. * if patients decide to use medications for weight loss, then the study will collect data from their chart that is recorded as part of routine monitoring for patients on weight loss medications. * if patients decide not to use any medications, the study will monitor physical exam and lab data collected as part of their routine medical care. the study will also try to understand reasons why patients did or did not start using a weight loss medication.


Eligibility criteria:
inclusion criteria: * ≥18 years old * ecog 0-2 * bmi ≥ 30kg/m2 * completed surgical staging with no evidence of residual disease * endometrioid endometrial adenocarcinoma, p53 wild type * stage 1 * undergoing active surveillance +/- brachytherapy exclusion criteria: * unable to participate in behavior weight loss * stroke, heart attack, end stage liver disease, or end stage kidney disease during the last 6 months. * currently on a glp-1 agonist * currently on insulin

Keywords: endometrial cancer endometrial cancer survivors weight management glp-1 agonist naltrexone/bupropion orlistat phentermine/topiramate
efficacy and safety of las41003 in the treatment of inflammatory tinea pedis

Conditions: Tinea Pedis

Summary: the aim of this study is to determine the efficacy and safety of a topical application of the combinational cream las41003 compared to application of its mono-substances after once daily treatment in patients with inflammatory tinea pedis.


Eligibility criteria:
inclusion criteria: * presence of tinea pedis caused by dermatophytes on one or both feet, characterized by physician's global assessment score of 2 ("notable signs and symptoms exist") or 3 ("prominent signs and symptoms exist") at baseline; * the physical examination must be without other disease findings unless the investigator considers an abnormality to be irrelevant to the outcome of the study; * female volunteers of childbearing potential must either be surgically sterile (hysterectomy or tubal ligation) or agree to use a reliable method of contraception with a failure rate of less than 1 % per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intra uterine devices \[iuds\], sexual abstinence or vasectomized partner; * patients must be willing and able to comply with the requirements of the trial protocol; * written informed consent obtained. exclusion criteria: * patients with hyperkeratotic chronic plantar tinea pedis (moccasin type); * receiving systemic therapy with cytotoxic or immunosuppressive drugs either concurrently or within 12 weeks before the baseline visit; * oral antifungal therapies within three months before study entry (8 months for oral terbinafine), systemic antibiotic or corticosteroid treatment, topical corticosteroids within 30 days before study entry; * patients with diabetes; * patients with compromised circulation; * evidence of drug or alcohol abuse; * pregnancy or nursing; * symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before the treatment phase and during the study; * participation in the treatment phase of another clinical study within the last four weeks prior to the first administration of investigational drug in this study; * known allergic reactions to components of the study preparations, hypersensitivity against cetylstearyl alcohol; * treatment with systemic or locally acting medications which might counter or influence the study aim within two weeks before the treatment phase of the study (e.g. glucocorticosteroids);

Keywords: tinea pedis
becker muscular dystrophy - a natural history study to predict efficacy of exon skipping

Conditions: Becker Muscular Dystrophy

Summary: this is a multi-center natural history study that will be conducted at participating centers in the cooperative international neuromuscular research group (cinrg). following a baseline evaluation, participants will have three follow-up visits over a three-year period. the investigators will characterize the becker muscular dystrophy phenotype, and correlate specific abnormal dystrophin proteins with the range of clinical outcomes.

we will utilize the cooperative international neuromuscular research group (cinrg) network to collect cohorts of becker muscular dystrophy (bmd) patients with in-frame deletions in the dystrophin gene. we will collect clinical data across multiple body systems and correlate these findings to the high-resolution deletion break-point mapping performed from the tissue samples. we will investigate the observed variability to deepen our understanding of molecular mechanisms relevant to the optimization of exon skipping therapeutic approaches.

Eligibility criteria:
inclusion criteria: * male * age 4 or older * diagnosis of bmd with an in-frame deletion in the dystrophin gene, where the boundaries of the mutations are confirmed. exclusion criteria: • investigator assessment of inability to comply with protocol
interest of eosinopia in the diagnosis of infection in the emergency department

Conditions: Eosinopenia

Summary: several studies have described the interest of eosinopenia as a marker of infection in internal medicine or in intensive care units. eosinopenia is an inexpensive and easily accessible biological marker of sepsis. retrospective work in the adult emergency departments of strasbourg university hospitals has shown the good specificity of this biological sign for the diagnosis of infection. our work aims to confirm the results by a more meaningful study. main objective: evaluation of the interest of eosinopenia in the diagnosis of bacterial infection in ed. methodology: inclusion of all patients with criteria for bacterial infection in ed, inclusion of an equivalent number of uninfected control patients. duration : 12 months multicentric prospective study 6 centers : strasbourg, hôpital nord franche comté, sélestat, wissembourg, colmar, mulhouse


Eligibility criteria:
inclusion criteria: * major patient * patient suspected of infection and benefiting from the routine practice of nfs, whatever the indication during his / her visit to the emergency room. * patient with or without criteria for bacterial infection * patient affiliated to a social security scheme * patient (or legal representative) who has agreed to participate in the study exclusion criteria: * anti tumor chemotherapy * immunosuppressive treatment * corticotherapy * antibiotherapy in progress * malignant hemopathy * evolutionary cancer * refusal to participate in the study * subjects under safeguard of justice * subject under guardianship or curatorship
placebo controlled study to assess the efficacy and safety of rapamycin in drug resistant epilepsy associated with tuberous sclerosis complex

Conditions: Tuberous Sclerosis Complex

Summary: the purpose of the rare-ts study is to determine safety, tolerability and efficacy of rapamycin versus placebo in a drug resistant epilepsy associated with tuberous sclerosis complex (tsc).

this is a two-arm, randomized, double-blind, placebo controlled study to evaluate the efficacy, tolerability, and safety of rapamycin versus placebo in a drug resistant epilepsy associated with tsc. the study consists of 3 phases for each patient: screening, dose adjustment blinded phase, core blinded phase, followed by open-label observation. patients who meet the eligibility criteria will be randomized to receive rapamycin or placebo. the randomization ratio is 1:1. randomization will be stratified by age, sex and and the number of antiepileptic drugs ever used in the patient's history (up to 3 drugs / more than 3 drugs).

Eligibility criteria:
inclusion criteria: * male or female aged from 3 months up to 50 years at the day of randomization * patients/parents/caregivers are willing to and able to give informed consent form for the participation in the study * patients/parents/caregivers are willing to and able to comply with all study requirements * definite diagnosis of tsc according to the consensus criteria (northrup, 2013) * drug-resistant epilepsy associated with tsc with at least 8 seizures during 4 weeks exclusion criteria: * history of treatment with mtor inhibitor in the three months prior to screening, * history of pseudo-epileptic seizures, * history of progressive cns disease other than tsc * recent surgery within 2 weeks prior to the screening * severe infection within 2 weeks prior to the screening * use of the cannabis derivatives * contraindications for mri or general anesthesia * occurrence of the serious comorbidities which, in the opinion of the investigator, may either put a patient at significant risk associated with the participation in the study or may influence the results of the study the investigator * pregnancy

Keywords: tuberous sclerosis complex, epilepsy, rapamycin, drug resistant epilepsy
evaluating the pharmacokinetics of 400 mg oral dose of raltegravir in hiv-infected pre-menopausal women

Conditions: HIV Infections

Summary: the purpose of this study is to characterize the pharmacokinetics of raltegravir in cervicovaginal fluids as compared to blood plasma of hiv-infected pre-menopausal women.

participants: six hiv-positive pre-menopausal women already undergoing therapy with raltegravir. procedures (methods): this study will be conducted at a single site: the university of north carolina at chapel hill. an outpatient screening visit will assess subject suitability and willingness to participate. during one pharmacokinetic visit women will be asked to self-collect cervicovaginal samples using a cervicovaginal fluid aspirator at the following time points: pre-dose and 1, 2, 4, 6, 8, 10, and 12 hours after raltegravir 400mg dose administration. one 3ml edta tube will be collected at the same time points to analyze blood plasma. a follow-up safety visit will be completed within 30 days of the inpatient stay.

Eligibility criteria:
inclusion criteria: * hiv-1 infection documented by hiv serology or detectable viral load * able to provide informed consent * in the opinion of the investigator, able to comply with their treatment regimen and study procedures * currently receiving raltegravir as treatment for hiv infection. subjects must have been on raltegravir for at least 3 weeks prior to the inpatient pharmacokinetic sampling stay. * all women of reproductive potential (who have not reached menopause or undergone bilateral oophorectomy, or tubal ligation) must have a negative serum β-hcg pregnancy test performed at screening. * subjects must test negative for sexually transmitted infections (gonorrhea, chlamydia, trichomonas, bacterial vaginosis, or syphilis) at screening * all study volunteers must agree not to participate in a conception process (e.g., active attempt to become pregnant). * subjects must be willing to abstain from intercourse, and vaginal instrumentation, including douching, within the 48 hours prior to all study visits. * if participating in sexual activity that could lead to pregnancy between study visits, the female study volunteer/male partner must use at least one reliable method of contraception (e.g., condoms, with or without a spermicidal agent; a diaphragm or cervical cap with spermicide; an iud) exclusion criteria: * pregnancy * breastfeeding * any condition which in the opinion of the investigator is likely to interfere with follow-up or ability to take the study medication appropriately * a positive test for bacterial vaginosis, syphilis, gonorrhea, chlamydia, or trichomonas

Keywords: pre-menopausal pharmacokinetics raltegravir women hiv-infected
tart cherry supplementation & gut microbiome and inflammation

Conditions: Inflammation; Glucose Regulation; Sleep

Summary: there has been a rapid increase in researching the use of tart cherry supplements in the past 5 years, particularly for inflammatory conditions. many formulations of cherry supplements exist, however there has been no comparison between these different types. this is particularly important in the realm of inflammation research because sugar is known to increase the inflammatory response. the pill form of cherry supplementation has no added sugar and is naturally low in sugar (\< 1g) while the juice form is higher from added sugar. recent work indicates tart cherry consumption can change gut microbiota, which may modify inflammation. the purpose of this study is to look at the effects of taking a cherry supplement, either in capsule or juice form, on the gut microbiome, inflammation, and health-related variables such as blood pressure, glucose regulation and sleep quality.

participants will consume a tart cherry or placebo product for 30 days and attend 5 visits in the exercise physiology lab at ohio university over the 30 day period. they will self-collect a stool sample at baseline, 14 days and 30 days after supplementation. blood samples will be taken at baseline, 7 days, 14 days, and 30 days after supplementation. throughout the study participates will rate symptoms (stomach, head, etc.), pain and sleep quality using an online survey for which the link will be emailed. participants will maintain normal diet and exercise routine and to track these for the duration of the study.

Eligibility criteria:
inclusion criteria: * 18-55 years old * participate in 150 minutes of exercise per week * non-smoker * have no known allergy to cherries or cherry juice * are not taking food supplements (turmeric/curcumin, cherry products, greens, etc.). -you must have access to the internet and be willing to record your food intake, physical activity and sleep quality/duration during the study. exclusion criteria: * not 18-55 years old. * have quit smoking less than one year ago. * have been diagnosed with a metabolic disorder such as diabetes, thyroid disorder, or high cholesterol. * are currently being treated for arthritis or an inflammatory condition, such as arthritis, gout, lupus or sjogren's syndrome. * are currently being treated for cardiovascular disease, high blood pressure, fibromyalgia, or irritable bowel syndrome. * are pregnant. * regularly consume cherries or are allergic to cherries. * currently use anti-inflammatory medications. * have used corticosteroids in the last two months. * are not willing to follow a low polyphenol diet. * are not willing to have blood drawn on 4 occasions. * are not willing to provide a stool sample on 3 occasions. * do not have access to the internet.
axios china (e7148)

Conditions: Pancreatic Pseudocyst and Walled-off Necrosis

Summary: to study the safety and effectiveness of the axios stent with electrocautery enhanced delivery system for endoscopic trans enteric drainage of pancreatic pseudocyst and walled-off necrosis in chinese population, to support the regulatory approval by cfda


Eligibility criteria:
inclusion criteria: 1. age between 18 and 75 years old(including 18 and 75 years old) 2. eligible for endoscopic intervention 3. acceptable candidate for endoscopic transluminal pancreatic pseudocyst drainage 4. diagnostic as symptomatic pancreatic pseudocysts ≥ 6cm in maximum diameter and walled-off necrosis ≥ 6cm in maximum diameter with ≥ 70% fluid content that are adherent to the gastric or bowel wall 5. patient understands the study requirements and the treatment procedures and provides written informed consent. 6. patient is willing to comply with all specified follow-up evaluations, including willingness to undergo a pre/post ct imaging study. exclusion criteria: 1. \ 75 years of age 2. pseudocysts or walled-off necrosis which require nasocystic drainage,or\<6cm in maximum diameter, or walled-off necrosis \< 70% fluid content 3. the fluid collection to be drained is an immature pseudocyst 4. the fluid collection to be drained is a cystic neoplasm 5. the fluid collection to be drained is a pseudoaneurysm 6. the fluid collection to be drained is a duplication cyst 7. the fluid collection to be drained is a non-inflammatory fluid collection 8. there is more than one pseudocyst requiring drainage 9. abnormal coagulation: inr \> 1.5 and not correctable presence of a bleeding disorder; platelets \< 50,000/mm3 10. altered anatomy that precludes the physician's ability to deliver the stent (decision on a case by case basis). 11. intervening gastric varices or vessels within a one centimeter radius of the needle (visible using endoscopy or endoscopic ultrasound) 12. any prior true anaphylactic reaction to contrast agents, nitinol (nickel titanium), silicone or any other materials contacting the patient. 13. female of childbearing potential with a positive pregnancy test prior to the procedure or intends to become pregnant during the study. 14. currently participating in another investigational drug of device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.
the voice-covid-19

Conditions: Covid19

Summary: the voice-covid study will evaluate the concordance of screening for symptoms of covid-19 using a voice based device (amazon alexa) compared to manual screening by a study coordinator for individuals entering the cardiology/heart failure clinic at the mcgill university health centre.

this study is an open-label, prospective, cross-over randomized study. voice-covid i: all individuals entering the heart failure (hf) clinic of the mcgill university health center will be asked to participate. a poster with instructions to ask the participants (employees or patients) to speak with the amazon alexa device. the participant will remain 6 feet away from the device. the amazon alexa will ask the survey questions. a study coordinator will then ask the same questions along with some additional questions about amazon alexa usability. voice-covid ii: a second cohort of 52 people will be then randomized to be screened for symptoms of covid-19 with an amazon alexa or a coordinator. we will study the correlation between the alexa response and the response to the study coordinator using k-squared statistic tests and screening question concordance.

Eligibility criteria:
inclusion criteria: * adults \>=18 yrs who is entering the hf clinic * speaks either english or french exclusion criteria: * none

Keywords: covid-19 alexa device voice-based technologies screening safety
study of bitopertin to evaluate the safety, tolerability, efficacy, and ppix concentrations in participants with epp

Conditions: Erythropoietic Protoporphyria

Summary: this is a phase 2, multi-center, double-blind, placebo-controlled, parallel group study of bitopertin to evaluate the safety, tolerability, efficacy, and ppix concentration change in participants with epp. participants may roll over to an open label extension portion after completing the double-blind treatment period.


Eligibility criteria:
inclusion criteria: 1. aged 18 years or older at the time of signing the informed consent form (icf). 2. diagnosis of epp, based on medical history by ferrochelatase ( fech) genotyping or by biochemical porphyrin analysis. 3. body weight ≥50 kg. 4. washout of at least 2 months prior to screening of afamelanotide and dersimelagon, if applicable. 5. aspartate aminotransferase (ast) and alanine transaminase (alt) \ lower limit of normal (lln). exclusion criteria: medical history: 1. major surgery within 8 weeks before screening or incomplete recovery from any previous surgery. 2. other than epp, an inherited or acquired red cell disease associated with anemia. 3. a history or known allergic reaction to any investigational product excipients or history of anaphylaxis to any food or drug. 4. history of liver transplantation. 5. history of alcohol dependence or excessive alcohol consumption, as assessed by the investigator. 6. human immunodeficiency virus (hiv), active hepatitis b, or c. 7. other medical or psychiatric condition or laboratory finding not specifically noted above that, in the judgment of the investigator or sponsor, would put the participant at unacceptable risk or otherwise preclude the participant from participating in the study 8. condition or concomitant medication that would confound the ability to interpret clinical, clinical laboratory, or participant diary data, including a major psychiatric condition that has had an exacerbation or required hospitalization in the last 6 months. treatment history: 9. concurrent or planned treatment with afamelanotide or dersimelagon during the study period. 10. treatment with opioids for any period \>7 days in the 2 months prior to screening or anticipated to require opioid use for \>7 days at any point during the study. 11. new treatment for anemia, including initiation of iron supplementation, in the 2 months prior to screening. 12. current or planned use of any drugs or herbal remedies known to be strong inhibitors or inducers of cyp3a4 enzymes for 28 days prior to the first dose and throughout the study. laboratory exclusions: 13. hemoglobin \<10 g/dl at screening.

Keywords: epp disc-1459 ro4917838 porphyria
telemonitoring of patients with copd in carinthia

Conditions: Pulmonary Disease, Chronic Obstructive (COPD)

Summary: evaluation whether the introduction of large-scale telemonitoring of patients with copd produces benefits in terms of reduced hospital readmissions, improved health related quality of life and health status. in addition, the trials evaluate the economical and organizational impact of the new services and examine their acceptability by patients and health professionals.


Eligibility criteria:
inclusion criteria: * copd 3 or 4 * be able to use the system provided * life expectancy \> 12 months exclusion criteria: