Kornimate/medical-research-clean huggingface dataset:
effect of silibinin(a) as a potential anti-obesity agent

Conditions: Overweight and Obesity; Hypercholesterolemia; Hypertriglyceridemia

Summary: our preliminary reports have found in silico and in vitro that the milk thistle derivative silibinin(a) is able to inhibit pancreatic lipase, in a similar way that the classical anti-obesity drug orlistat. therefore, the investigators want to carry out the present trial in order to confirm that silibinin(a) is able to in vivo inhibit pancreatic lipase, which will reduce the fat absorption and therefore will decrease the amount of energy from food intake. considering that milk thistle has been extensively studied in humans as liver-protector, the investigators consider that the use of human subjects will be of great interest to accelerate the employment of this compound to improve the effectiveness of dietary treatment in overweight/obese subjects.


Eligibility criteria:
inclusion criteria: * bmi \> 24,9 * voluntarily participate in the study exclusion criteria: * significant cognitive impairment * psychiatric disorders * chronic pharmacological treatment that may affect the effectiveness of the dietary intervention (corticosteroids, thyroid hormones, oral antidiabetic agents or lipid-lowering drugs) * chronic disease that may interfere with dietary therapy (cancer, renal or hepatic impairment, chronic gastrointestinal conditions) * acute disease episodes during the study * subjects who followed a hypocaloric diet at the allocation time or in the 3 months prior to the beginning of the study * pregnant women
longitudinal endpoint assessment of disease burden in hd

Conditions: Huntington Disease

Summary: lead-hd is intended to collect and analyze self-reported health information from individuals with huntington disease (hd) or prodromal hd participating in a 24-month longitudinal natural history study using remote technologies.

the lead-hd study will be offered via hsg's online observational research platform called myhdstory®. this direct to patient study will collect and analyze self-reported health information from individuals with huntington disease (hd) or prodromal hd in a 24-month longitudinal natural history study that participants complete at any time and with their own electronic device.

Eligibility criteria:
inclusion criteria: * be 18 years of age or older; * be willing and able to provide informed consent electronically; * self-report, when answering as a participant, that you have been diagnosed with hd by a doctor, or have undergone genetic testing and been found to carry the gene mutation responsible for hd but have not been clinically diagnosed with hd (prodromal hd); * have the ability to answer online questions or direct someone else to enter answers for them; * have the ability to ambulate independently and take care of some of your personal needs; * have the ability to read and understand english; * be willing to create a unique identifier based on personal demographic information; * reside in the united states or its territories. surveys can only be completed in the us. if you move outside of the us, you will no longer be able to participate; * own or have access to an electronic device and secure internet connectivity exclusion criteria: -
study of simmitecan hydrochloride in the treatment of advanced solid tumor

Conditions: Advanced Solid Tumor

Summary: rational: simmitecan is an anticancer ester prodrug, which involves activation to chimmitecan. chimmitecan，a novel cpt derivative, exhibited potent antitumor activities both in vitro and in vivo by inhibiting topoisomerase i. also exerted comparable effects on topoisomerase i compared with topotecan and sn38 and possessed improved anticancer potency and pharmacologic profiles, compared with the clinically available cpt analogues. purpose: to determine the maximum tolerated dose, the safety profile and pharmacokinetics of simmitecan.


Eligibility criteria:
inclusion criteria: * relapsed or refractory to standard therapy or no standard therapy available. * at least one measurable lesion. * age = 18\~65 years. * ecog=0-1. * life expectancy ≥ 12 weeks. * more than 4 weeks after operation, chemotherapy, radiotherapy, cytotoxic agents or tyrosine kinase inhibitors. * adequate organ function: haemoglobin ≥ 100 g/l, absolute neutrophil count \[anc\] ≥ 2×109/l,platelets ≥ 100 × 109/l), serum bilirubin ≤ 1.0×uln, aspartate aminotransferase (ast) or alanine aminotransferase (alt) \< 1.5×uln (if liver metastases, serum transaminase ≤ 2.5×uln), creatinine clearance ≥ 50 ml/min , lvef ≤ 50%, qt interval (corrected by fridericia): male \< 450 ms, female \< 470 ms * female: all subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 6 months after the last dose of test article. child bearing potential, a negative urine or serum pregnancy test result before initiating famitinib. male: all subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 6 months after the last dose of test article. * signed and dated informed consent. willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure. exclusion criteria: * less than 4 weeks from the last clinical trial. * known spinal cord compression or diseases of brain or pia mater by ct /mri screening. * patients had ever severe diarrhea with prior therapy of camptothecin drugs. * concurrent severe or uncontrolled medical disease (serious infection, serious diabetes) * significant cardiovascular disease or condition including ≥ class ii cardiac function (nyha) * acute and chronic viral hepatitis. (if hbsag +, hbv-dna quantification ≤ lln.) * pregnant, lactation period or men/women ready to birth. * psychiatric disorder or altered mental status. * evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study

Keywords: tolerability pharmacokinetics
real-world pharmacokinetic/pharmacodynamic study of eravacycline in critically iii patients

Conditions: Eravacycline; Pharmacokinetics; Bacteria Infection; Bacterial Resistance to Antimicrobial; Empirical Antimicrobial Therapy

Summary: the aim of this study is to evaluate the efficacy of eravacycline in the treatment of patients with bacterial infection and to assess the pharmacokinetics of eravacycline and to establish a population pharmacokinetic model of eravacycline.


Eligibility criteria:
inclusion criteria: * adult male or female aged 18-75 years * not respond to initial empirical treatment, treatment time to reach eravacycline steady-state concentration * empirical antimicrobial treatment is ineffective * eravacycline application for ≥ 3 days * understand and sign informed consent exclusion criteria: * urinary tract infection * allergic to eravacycline, tigecycline antibiotics or any excipients or have previously experienced serious adverse reactions * any unstable or potentially endangering the safety of the subject and their compliance with the study as judged by the investigator; comorbidities or social circumstances that can make the subject unable to follow the study plan or even endanger the safety of the patient * patients expected to survive for no longer than 48h.
evaluation of patients with non-cardiac chest pain

Conditions: Non-Cardiac Chest Pain; Gastroesophageal Reflux Disease

Summary: the purpose of this study is to find out how common diseases of the esophagus can cause chest pain. gastroesophageal reflux disease (gerd), commonly known as heartburn, is a common cause of chest pain in patients that do not have heart problems. the study test is called pillcam eso, it is a small, pill sized capsule that has a small camera inside it. the camera will take pictures of the esophagus and the stomach as it goes down. findings of the pillcam eso will be compared to findings during conventional upper endoscopy.

non-cardiac chest pain (nccp) is defined by recurrent episodes of retrosternal chest pain in the absence of significant cardiovascular disease after a thorough cardiac evaluation. it accounts for 2-5% of all emergency department visits. studies examining the prevalence of esophago-gastric lesions in patients with nccp referred to gastroenterologists have found esophagitis, esophageal ulcers, hiatal hernias, gastritis, and gastric ulcers in 62% of patients. advances in endoscopic technologies, particularly, the introduction of the wireless video-capsule (pillcam eso) allows for the possibility of direct visualization of the upper gastrointestinal tract in the emergency department. during capsule endoscopy, a patient will swallow a pill-sized video-capsule, the wireless images of the gastrointestinal tract are transmitted to a computer. findings of the pillcam eso will be then compared to findings during conventional upper endoscopy.

Eligibility criteria:
inclusion criteria: * age 18 to 80 years * negative cardiac evaluation in the emergency department * pre-established access to a primary care provider * ability to give informed consent exclusion criteria: * known history of ischemic heart disease * proton pump inhibitor therapy * known or suspected obstructions or strictures in the gastrointestinal tract, including a history of crohn's disease, gastrointestinal surgery other than cholecystectomy or appendectomy. * permanent pacemakers/defibrillators or other implantable wireless devices * known pregnancy * unstable medical conditions * inability to follow instructions * active psychiatric conditions that preclude participation in the study

Keywords: capsule endoscopy wireless imaging esophagus stomach
rollover study for participants previously enrolled in clinical trials of povorcitinib

Conditions: Hidradenitis Suppurativa (HS)

Summary: rollover study for participants from predetermined, incyte-sponsored parent clinical trials of povorcitinib.


Eligibility criteria:
inclusion criteria: * ability to comprehend and willingness to sign a written icf for the study. * completed the treatment period of a predetermined, incyte-sponsored, povorcitinib parent study without safety or tolerability concerns, per investigator's assessment. * received clinical benefit from treatment with study drug during the parent study, as determined by the investigator. * demonstrated compliance, as assessed by the investigator, with the parent protocol requirements. * willingness to avoid pregnancy or fathering children as defined in the protocol. * willingness and ability to comply with the study protocol and procedures. exclusion criteria: * had been permanently discontinued from study treatment during the parent study. * had temporary study drug interruption due to safety and/or efficacy reasons at or after the final visit of the parent study. * received at least 1 dose of either of the following therapies within the 28 days prior to starting treatment in this rollover study: * biologic immunomodulator (examples include but are not limited to adalimumab, bimekizumab, dupilumab, infliximab, nemolizumab, secukinumab). * live, attenuated vaccine. * plans for administration of a live, attenuated vaccine during this study or within 8 weeks after the last dose of study drug. * women who are pregnant (or who are considering pregnancy) or breastfeeding. * known hypersensitivity or severe reaction to povorcitinib or excipients of povorcitinib and/or other products in the same class. * currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study. * any condition that would, in the investigator's and/or sponsor's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: incb054707 povorcitinib hidradenitis suppurativa hidradenitis hs
pilot study of effects of cold vests on cardiovascular risk markers

Conditions: Cardiovascular Risk Factors; Basal Metabolic Rate

Summary: randomized trial of supplying a cold vest as compared with controls (no cold vest) on cardiovascular risk factors such as blood lipids, insulin, blood pressure and body weight and also on basal metabolic rate. recruitment of 100 participants and 70 are randomized to being given a vest which they can use to increase basal metabolic rate during 1-2 hours (as long as the pre-cooled vest stays cool) by activating brown adipose tissue and/or shivering. the remaining 30 subjects will constitute a control group. lab tests and anthropometrics are checked at baseline, after 2 months and after 1 year.


Eligibility criteria:
inclusion criteria: * healthy subjects that have no known metabolic relevant diseases exclusion criteria: * thyroid disease, * mental disorders, * language problems
phase iiib study evaluating the effects of atazanavir powder with ritonavir in hiv-infected pediatric patients

Conditions: HIV

Summary: the purpose of this study is to describe the safety, efficacy, and pharmacokinetics of a regimen of atazanavir powder boosted with ritonavir and an optimized dual nucleoside reverse transcriptase inhibitor in pediatric patients aged ≥3 months to \<11 years.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com key inclusion criteria: * confirmed hiv-1 infection diagnosed by protocol criteria * screening hiv rna level ≥1000 copies/ml * ≥3 months to \<11 years of age at time of first treatment * antiretroviral-naive or -experienced * at screening, all participants must have genotypic sensitivity to atazanavir and at least 2 nucleoside reverse transcriptase inhibitors (nrtis), which must be approved for pediatric use at the local country. * antiretroviral-experienced patients must also have documented phenotypic sensitivity at screening to atazanavir (fold change in susceptibility \<2.2) and to at least 2 nrtis that are approved in their country key exclusion criteria: * experienced participants who received atazanavir or atazanavir/ritonavir at any time prior to study enrollment or who have a history of 2 or more protease inhibitor failures * antiretroviral-naïve or -experienced hiv-1-infected patients with contraindication to study medications * cardiac rhythm abnormalities * need for tenofovir * weight \<5 or ≥35kg * \>grade 2 abnormality in aspartate transaminase/alanine transaminase levels * coinfection with either hepatitis b or c virus * any active centers for disease control and prevention category c clinical condition

Keywords: pediatric
assessing a endoscopic mucosal resection site using different endoscopic imaging methods

Conditions: Post-endoscopic Mucosal Resection of Colon Polyps

Summary: the purpose of this study is to compare the accuracy of using different endoscopic imaging technique (white light, white light with near focus, narrow band imaging (nbi), nbi with near focus) for detection of residual neoplastic tissue at site of prior emr

residual neoplasia after emr is a common. optimal surveillance protocols are not clearly defined. there is a need for better imaging modalities to evaluate for residual disease. suspected residual tissue can be confirmed with repeat colonoscopy or can be empirically treated. however, this can lead to either frequent colonoscopy or overtreatment. this presents more cost and financial burden to the patient. with the introduction of newer colonoscopes that have near focus/zoom capability, it is important to assess whether the near focus technology offers better accuracy for detection of residual neoplastic tissue. with better accuracy to confidently rule out residual neoplasia using newer imaging modality, additional treatment or biopsy at the previous emr may be avoided. furthermore, the interval for surveillance colonoscopy can be lengthened.

Eligibility criteria:
inclusion criteria: * post-emr follow up at 6-12 months exclusion criteria: * non-corrected coagulopathy * pregnancy * breast feeding

Keywords: endoscopic mucosal resection, residual polyp, near focus imaging
advancing cath lab results with ffrangio coronary physiology assessment

Conditions: Percutaneous Coronary Intervention

Summary: to test whether ffrangio-guided treatment is non-inferior to conventional pressure wire-guided treatment in patients with coronary artery disease.

all-rise is a prospective, randomized, multi-center, controlled post-market study. the all-rise study is designed to test whether ffrangio-guided treatment is non-inferior to conventional pressure wire-guided treatment in patients with coronary artery disease being evaluated for percutaneous coronary intervention (pci) with respect to major adverse cardiac events (mace) at one year.

Eligibility criteria:
inclusion criteria: 1. adult patient ( ≥18 years old) presenting with ccs or nsteacs with one or more study lesion(s) deemed appropriate (diameter stenosis 50-90%) for both pressure-wire and ffrangio physiologic assessment. general exclusion criteria: 1. subject with st-elevation (mi (stemi) within 72 hours at time of study enrollment 2. prior coronary artery bypass graft (cabg) with patent grafts to the study vessel(s) 3. patients undergoing coronary physiologic assessment where one possible outcome is referral for cabg 4. the study vessel supplies a significant nonviable territory (e.g., prior transmural mi) 5. severe left sided valvular heart disease 6. most recent documented lvef ≤30% 7. women who are pregnant or breastfeeding (women of childbearing potential are required to have negative pregnancy test within 1 week of index procedure) 8. patients with life expectancy \<1 year life as estimated by treating physician. 9. subjects enrolled in other ongoing non-registry clinical studies that would impact conduct or outcomes of this study (registries and long-term follow-up of other studies are allowed) 10. subjects who have undergone angiographic or wire-based coronary physiological assessment for 1 or more potential study lesions within 30 days of enrollment.

Keywords: pci coronary artery disease ffrangio pressure wire-guided
fetal 3d study (fetal body composition and volumes study)

Conditions: Fetal Growth Restriction; Fetal Growth Abnormality

Summary: normal fetal growth is a critical component for a healthy pregnancy and for ensuring the health and well-being of infants throughout childhood and adolescence. one promising area of research suggests that changes in fetal soft tissue may be the earliest changes that occur in pathologic growth. three-dimensional volume assessments may be used to detect changes in fetal lean mass, fat mass, and organ size that result from pathologic growth earlier than conventional 2d measures. this knowledge may lead to interventions that could minimize or prevent pregnancy and newborn health problems in the future.

the nichd fetal growth study was a multi-site, prospective cohort study designed to establish a standard for normal fetal growth (velocity) and size for gestational age in the u.s. population. for the singleton study, 2,334 low-risk, non-obese gravidas were recruited from each of 4 self-identified race/ethnicity backgrounds. an additional 468 obese women and 171 dichorionic twin gestations were recruited. after an initial sonogram in the first trimester, women were randomized to serial ultrasonology schedules. each schedule comprised five additional sonograms for fetal biometry (six in twins) plus additional image and 3d volume acquisition for later analysis. ultrasound measurements at each follow-up visit included standard fetal biometrics ((bpd, hc, ac, fl) and the following volumes in the singleton study if they were able to be obtained: 1st trimester: fetus and gestational sac; 2nd and 3rd trimesters: head, cerebellum, face, chest, heart, abdomen, pelvis, arm and thigh. in twins, the volumes collected were 1st trimester: fetus and gestational sac and in the 2nd and 3rd trimesters the thigh. in addition to ultrasound, this study recorded maternal anthropometrics and a brief interview to capture changes in health status, stress and depression, and physical activity at each follow-up visit. blood draws at baseline and at targeted gestational ages were obtained for the eventual identification of biomarkers indicative of fetal growth were collected. after delivery, neonatal anthropometric measures were assessed, placental biospecimens were collected, and select information about the obstetrical course and newborn status were abstracted from medical charts. the fetal 3d study is being conducted to catalog and perform 2 dimensional (2d) and 3 dimensional (3d) measurement of the obstetrical ultrasound images in the existing bank of singleton and twin gestations collected from the nichd fetal growth studies. the research study aims to understand the relationship between gravid diseases and longitudinal changes in fetal body composition (subcutaneous fat, lean mass) and organ measurements (in singletons) over the course of pregnancy.

Eligibility criteria:
inclusion criteria: * women with ultrasound data collected from the nichd fetal growth studies-singletons and twin gestations exclusion criteria: * none