Kornimate/medical-research-clean huggingface dataset:
a phase i/ii clinical trial assessing safety and efficacy of bzl101 for metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: bzl 101 is an aqueous extract from herba scutellaria barbata d. don of the lamiaceae family. preclinical studies suggest that this herb has antitumor activity for breast cancer and preliminary clinical data suggest that it is tolerable in patients with metastatic breast cancer. the overall goals of this phase i/ii trial are to assess the toxicity, maximum tolerated dose, safety and preliminary efficacy of bzl101 for the treatment of advanced metastatic breast cancer.


Eligibility criteria:
key inclusion criteria: * women 18 years or older * histologically confirmed breast cancer * clinical evidence of metastatic (stage iv) metastasis (other than bone metastasis) * availability of estrogen and progesterone receptor status * at least one measurable disease site defined by recist criteria, 30 days prior to study therapy * for the phase 1, no more that 3 prior cytotoxic regimens for metastatic breast cancer. for the phase 2, no more than 2 prior cytotoxic regimens for metastatic breast cancer * life expectancy ≥ 12 weeks * eastern cooperative oncology group performance status ≤2 * women of child bearing potential must agree to 2 forms of contraception during the course of the trial. key exclusion criteria: * inability to understand/unwillingness to sign a written informed consent * any significant side effects related to prior chemo, radiation, biology or hormonal therapy that did not resolve in the judgment of the investigator * currently using an investigational agent * clinically significant gastrointestinal abnormalities * currently using coumadin at therapeutic doses or within 2 weeks of taking study medication * concurrent palliative radiation or anti-cancer treatment * women who report pregnancy, are breast-feeding or have a positive pregnancy test

Keywords: breast cancer bionovo bzl101 chinese herbs
long term results of starr with contour transtar

Conditions: Rectal Prolapse; Rectocele; Intussusception of Rectum

Summary: obstructed defecation syndrome (ods) is a widespread and disabling syndrome. with this study the investigators want to evaluate the long term results of stapled transanal rectal resection (starr) performed with contour transtar device in the treatment of ods. a re-evaluation of 113 patients subjected to starr from june 2007 to january 2010 was conducted.


Eligibility criteria:
inclusion criteria: * ods * presence of a rectocele that did not empty and/or a recto-rectal or recto-anal intussusception. exclusion criteria: * anal sphincter contractile deficiency * previous rectal resection
dapagliflozin and hydrochlorothiazide in recurring kidney stone patients

Conditions: Urolithiasis; Hyperoxaluria

Summary: current prevention strategies in patients with recurrence of kidney stones show especially in high-risk patients a diversely and in the long-term not successful outcome in a sustainable number of cases. recent studies have revealed that dapagliflozin has the potential to decrease risk and incidence of urolithiasis events especially in patients suffering from diabetes. the investigators propose that dapagliflozin has the potential to increase the metabolic situation of hyperoxaluric patients with recurrence of urolithiasis. the investigators therefore test whether dapagliflozin can decrease the oxalate excretion compared to the current strategy with hydrochlorothiazide. the study may open up a new way of preventing urolithiasis in patients with high-risk of recurring urolithiasis.


Eligibility criteria:
inclusion criteria: • calcium-oxalate stone formers with high risk of reoccurrence defined as: * at least two symptomatic or surgically treated kidney stones within the last 10 years and/or * single stone kidney formers with risk factors including: a.) positive medical family history on kidney stone formations of at least one blood related relative in the first degree or at least two blood related relatives in the second degree and/ or b.) onset of kidney stone formations within the third life decade or earlier and/ or c.) metabolic syndrome d.) obesity (bmi ≥ 30 kg/m²) exclusion criteria: * age \< 18 years * malabsorption disorder * egfr \< 30 ml/min/1,73 m2

Keywords: urolithiasis hyperoxaluria
the effect of an acute increase in plasma il-6 on glucose tolerance when a meal is administered intraduodenally

Conditions: Postprandial Glucose Homeostasis

Summary: the aim of the study is to investigate and clarify whether the effect of il-6 on glucose tolerance and insulin secretion are secondary to the changes in gastric emptying. the literature provides no information regarding a role for interleukin-6 (il-6) in the regulation of beta cell function (glucose or meal-stimulated insulin secretion) in humans. previous studies infusing il-6 into humans have primarily focused on insulin action and the effects on peripheral insulin sensitivity whereas a potential effect on insulin secretion has been neglected. we have demonstrated that an acute increase in il-6, obtained by a single bolus of il-6, potentiated glucose-induced insulin secretion in a glucagon-like peptide-1 (glp-1) dependent manner in mice1. in mice, il-6 enhanced insulin secretion in a dose- and glucose-dependent manner, along with increasing concentrations of glp-1. interleukin-6 had no effect on insulin secretion in glp-1 receptor knock-out mice or in mice treated with the glp-1 receptor antagonist. thus, in mice, glp-1 has proven an essential mediator of il-6 actions on beta cell function. importantly, a single bolus of il-6 also significantly increased glucose-stimulated insulin secretion in several mouse models of obesity and diabetes (diet-induced obesity, the ob/ob and the db/db mouse). own data show that an infusion of il-6 causes a significant delay in the rate of gastric emptying (ge) after a mixed meal in healthy young men. data showed that this delay in ge is associated with much improved glucose tolerance and insulin secretion (unpublished data). in the present study we wish to investigate whether the beneficial effects of il-6 on postprandial glucose tolerance and insulin secretion are dependent on a delay in gastric emptying. we will bypass the ventricle and infuse a mixed meal directly into the duodenum of healthy young men. this study has the potential to show that the known effect of il-6 on postprandial glucose tolerance is dependent on a delayed ge.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years and ≤ 35 years * healthy (based on screening) exclusion criteria: * smoking * bmi \ 25 kg/m2 * evidence of severe thyroid, liver, lung, heart or kidney disease
threshold dose distribution for pistachio allergy

Conditions: Allergy; Food Allergy

Summary: the main objective of this study is to describe the distribution of reactogenic thresholds for pistachio. the secondary objectives are to 1) describe the clinical severity of allergic reactions to pistachio in an oral challenge test, 2) compare the reactogenic thresholds of pistachio and cashew nut on matched data and 3) evaluate predictive factors of a low reactogenic threshold

nuts, including almonds, walnuts, cashews, pistachio and hazelnut, are among the food allergens most frequently involved in food allergies in children with an estimated prevalence. between 0.05 and 4.9%. according to data from the allergo-vigilance network, peanuts and the group of nuts, led by cashews, are alone responsible for 51.4% of food anaphylaxis in children. the pistachio belongs to the same botanical family as the cashew nut (anacardiumouest) and the mango (mangifera indica): the anacardiaceae. botanically, pistachio and cashew are closely related and can both be responsible for moderate to severe immediate allergic reactions. furthermore, in a previous publication by the team, co-sensitization to pistachio was observed in 98% of children allergic to cashew nuts with only 34% confirmed allergic to pistachio. in the case of allergy to both anacardiaceae, in a small number of patients, the investigators reported a reactogenic threshold for pistachio greater than or equal to that for cashew nuts. to our knowledge, there is currently only one study that has evaluated the reactogenic threshold for pistachio, compared to other nuts.

Eligibility criteria:
inclusion criteria: * patients under 18 years of age who had a positive pistachio challenge test between january 2021 and december 2023, in the pediatric allergology unit of the nancy chru. exclusion criteria: * patients who had a questionable oral pistachio provocation test. * patients who had a negative pistachio oral provocation test.
prevalence and spectrum of cancer susceptibility among patients with advanced colorectal polyps

Conditions: Colorectal Neoplasm

Summary: the study is being conducted to determine the prevalence and risk factors for germline cancer susceptibility genetic mutations among patients with advanced colorectal polyps.


Eligibility criteria:
inclusion criteria: * provision to sign and date the consent form * stated willingness to comply with all study procedures and be available for the duration of the study * be a male or female aged 18-89 * undergone colonoscopy * at least one advanced colorectal polyp, defined as having any of the following: * any polyp ≥ 1cm (adenoma or serrated polyp) * any polyp with villous architecture * any polyp with high-grade dysplasia * sessile serrated polyps with any dysplasia * traditional serrated adenoma exclusion criteria: * known hereditary cancer syndrome * personal history of inflammatory bowel disease * personal history of colorectal cancer * polyp histology or size unavailable or not documented

Keywords: genetics polyps cancer multi-gene panel
the efficacy and safety of the 1,414 nm nd:yag laser system for alleviating back pain in a lumbar disc patient

Conditions: Lumbar Herniated Intervertebral Disc

Summary: this study aims to evaluate the efficacy and safety of the 1,414nm nd:yag laser system (accuplasti) added to percutaneous epidural neuroplasty (pen), a conventional treatment, to alleviate back pain in a lumbar herniated intervertebral disc patient.


Eligibility criteria:
inclusion criteria: * adult patients 19-79 years old * patients with moderate disability based on the oswestry disability index (odi), among those diagnosed with a single level of unilateral herniated intervertebral disc among the 3rd-4th and 4th-5th lumbar vertebrae, or the 5th lumbar vertebra-sacral vertebra with back pain or radiating pain in the lower extremities that has been unresponsive to conservative therapy for more than six weeks * patients who have language skills enough to answer questionnaires * patients who agree to voluntarily participate in this study and to sign the informed consent form, and who are able to participate for the entire period of this study exclusion criteria: * patients with a multi-level, far-lateral, or bilateral lumbar herniated intervertebral disc * patients who use an electronic medical device for their cardiovascular system * patients who have spondylolisthesis in the relevant lesion * patients with neurological defects * patients who had undergone surgery on the relevant lumbar vertebra * patients with cauda equina syndrome * patients with congenital spinal deformity * patients with spinal fracture * patients with spinal infection, tumor, or other form of inflammatory spondylopathy * patients with coagulation disorder * patients with a history of malignant tumor (except those with a cured tumor and no re- occurrence for the last five years) * patients who had participated in another clinical study within 30 days from their screening visit * female patients with child-bearing potential who do not agree to use a medically acceptable contraceptive method\* for up to 24 weeks after the use of the investigational medical device during this study * medically acceptable contraceptive method: condom, oral contraceptive pills taken continuously for more than three months, contraceptive injection or implants, intra- uterine contraceptive device, etc. * patients who are pregnant or breastfeeding * other patients who are considered unfit to participate in this study with clinically significant findings based on the investigator's judgment
post market clinical follow-up kerifuse®

Conditions: Arthritis

Summary: the general objective of this study is to evaluate the performances and the safety related to the kerifuse® intramedullary arthrodesis implant and associated instrumentation used in accordance with their approved labelling and instruction for use. performance and safety of kerifuse® intramedullary arthrodesis implant will be established on short and middle-terms in regards to the implant life-cycle.


Eligibility criteria:
inclusion criteria: * patients ≥ 18 years, * patients that will have a surgery using a kerifuse® implant in accordance with the approved labelling and ifu. exclusion criteria: * pregnant or nursing women, * patients with intellectual disabilities who cannot follow the instructions of their surgeon, * patients with a contraindication to surgery and more specifically to the implantation of kerifuse®, * patients with acute or chronic infections, local or systemic, * patients with sensitivities or allergies to the implant components (nickel, titanium).
vestibular infant screening - rehabilitation

Conditions: Vestibular Disorder

Summary: the goal of this clinical trial is to investigate the short-term effect of a structured, combined postural control and gaze stabilisation protocol (vis-rehab protocol) in a group of vestibular-impaired children of different age categories (3-17 years). the main questions it aims to answer are: * what is the short-term effect of the vis-rehab protocol? * what are the most important factors that may influence the effect of and outcome after application of the vis-rehab protocol? the participant will undergo both an active rehabilitation program (vis-rehab protocol) and a period during which physical therapy is discontinued (ctrl protocol).: - vis-rehab protocol: postural control (static and dynamic postural stability exercises), gaze stability exercises (oculomotor function and vor-exercises) \& general gross motor training with focus on gaze stability and postural control. researchers will compare the vis-rehab protocol with receiving no therapy (ctrl protocol) to evaluate potential enhancements in postural stability, gaze stability, motor performance and quality of life.


Eligibility criteria:
inclusion criteria: * patients with identified vestibular dysfunction * with or without concomitant hearing loss and/or cochlear implant (ci) exclusion criteria: * children incapable to understand simple instructions (due to severe cognitive disorders, impaired language comprehension, etc.) * severe disorders of other primary sensory input systems for balance function * severe neuromotor disorders (incapable of independent standing and walking) * severe muscle tone disorders (e.g. cerebral palsy) * severe orthopaedic dysfunctions * patients with vision problems that cannot be corrected for * children with planned ci-surgery within 5 months before or during the study period

Keywords: therapy vestibular rehabilitation therapy vrt gaze stability postural control
"estimation study" for endocardial mesenchymal stem cells implantation in patients after acute myocardial infarction

Conditions: Acute Myocardial Infarction; Heart Failure

Summary: the investigators hypothesised that endocardial stem cells implantation following after percutaneous coronary intervention (pci) could reduce the scar formation and increase reverse remodeling in patients with primary acute myocardial infarction.


Eligibility criteria:
inclusion criteria: * patients with acute q-wave myocardial infarction after thrombolitic therapy during 6-36 hours from the onsent of signs * oclusion or significant stenosis of infarct-related left anterior descending artery (lad) * left ventricle ejection fraction (lvef) \< 50% measured by echo exclusion criteria: * thrombolysis of pyrrolase or streptokinase * surgical unsignificant stenosis of lad * indications for cabg * cardiogenic shock * uncontrolled hypertension * thrombocytopenia * ongoing bleeding * anemia \< 100 g/l * oncology * patients, who required anticoagulation therapy at the time of inclusion * obesity, bmi\>40 * severe comorbidities * unwillingness to participate

Keywords: endocardial stem cells injection percutaneous coronary intervention
severe aortic stenosis in patients referred for valve surgery

Conditions: Aortic Stenosis; Valvular Heart Disease; Symptomatic Aortic Stenosis

Summary: our main hypothesis on the present study is that new parameters such as risk-taking behavior, patients motivation, health related quality of life, new biomarkers and more precise echocardiography measures in addition to traditional parameters will improve pre-operative risk assessment in patients with as and better guide patients and doctors in decision whether to operate or not.

patients referred for surgery are included thorough reading referral letter. data collected in the study wil be compared with data from medical records and clinical examination. data entered will be controlled by two investigators. data wil be compared to national norms and from result of other studies.

Eligibility criteria:
inclusion criteria: * patients above 18 years with symptomatic as referred to preoperative examination. exclusion criteria: * exclusion: patients who do not want to participate. patients not able to speak and read norwegian.

Keywords: hrqol aortic stenosis aortic valve surgery
inpatient evaluation of the md-logic artificial pancreas system in patients with type 1 diabetes

Conditions: Diabetes Type 1

Summary: the purpose of this feasibility study is to evaluate the mdlap (md-logic artificial pancreas system)automated insulin management system using continuous glucose monitoring (cgm) and subcutaneous insulin pump infusion in individuals with type 1 diabetes. the study will include 3 inpatient admissions (12-24 hr), which will include overnight sleep, over-bolus meal, under-bolus meal and exercise.

the purpose of this feasibility study is to evaluate the mdlap (md-logic artificial pancreas system)automated insulin management system using continuous glucose monitoring (cgm) and subcutaneous insulin pump infusion in individuals with type 1 diabetes. the study will include 3 inpatient admissions (12-24 hr), which will include overnight sleep, over-bolus meal, under-bolus meal and exercise. during the the visits, meal boluses will be semi-automated, with manual meal announcement by the physician/nurse, automated bolus recommendation by the system, and automated delivery of the bolus following confirmation of the recommendation. between-meal insulin dosing will be fully automated. bolus confirmation by the physician/nurse will be requested by the closed loop controller only when it determines that carbohydrates may be necessary to avoid hypoglycemia following the bolus.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of type 1 diabetes for at least one year and using an insulin pump for at least 6 months * age 12 to 65 years * hemoglobin a1c (hba1c) between 5.0% and 10.5%, as measured with dca2000 or equivalent device * for females, not currently known to be pregnant * demonstration of proper mental status and cognition for the study * an understanding of and willingness to follow the protocol and sign the informed consent or assent exclusion criteria: * diabetic ketoacidosis in the past 6 months * severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment * history of a seizure disorder (except hypoglycemic seizure). * coronary artery disease or heart failure. * cystic fibrosis * active infection * a known medical condition that in the judgment of the investigator might interfere with the completion of the protocol * a recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the exercise protocol * current use of a beta blocker medication * hematocrit \<30% * use of pseudoephedrine 48 hours prior to clinical research center (crc) admission

Keywords: diabetes type 1 artificial pancreas
a study to evaluate the efficacy and safety of ruxolitinib cream in participants with cutaneous lichen planus

Conditions: Cutaneous Lichen Planus

Summary: the purpose of this study will be to evaluate efficacy and safety of ruxolitinib cream in participants with cutaneous lichen planus. this is randomized, double-blind, vehicle-controlled (dbvc) study with a dbvc period of 16 weeks followed by an open label period (ole) period of 16 weeks.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of lp with predominant cutaneous involvement. * iga score of 3 or 4 at screening and baseline. * baseline lp-related itch nrs score ≥ 4. * willingness to avoid pregnancy or fathering children. exclusion criteria: * concurrent conditions and history of other diseases: 1. variants of lp deemed by the investigators to be inappropriate for topical treatment, including but not limited to predominant mucosal (such as oral or vaginal) lp. 2. active ongoing inflammatory diseases of the skin other than lp that might confound the evaluation of lp lesions or compromise participant safety. 3. any other concomitant skin disorder (eg, generalized erythroderma such as netherton's syndrome), pigmentation, or extensive scarring that in the opinion of the investigator may interfere with the evaluation of lp lesions or compromise participant safety. 4. immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, or wiskott-aldrich syndrome). 5. chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before baseline. 6. active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chickenpox, clinically infected ad, or impetigo) within 1 week before baseline. * laboratory values outside of the protocol-defined criteria. * pregnant or lactating participants, or those considering pregnancy during the period of their study participation. * other exclusive criteria may apply.

Keywords: lichen planus skin diseases 18424 ruxolitinib topical cream
the impact of heartfulness self-care program on anxiety, satisfaction with life, and loneliness levels in students and staff in high schools.

Conditions: Anxiety; Satisfaction With Life; Loneliness

Summary: this quantitative study assesses the baseline anxiety, satisfaction with life, and loneliness scores in students and staff in a global study. assessments at baseline will include the gad, swls, and ucla loneliness scale, and the same questionnaires were collected in week 4 and week 8. the google form questionnaire will ask the high schoolers and staff for their email address and their parent's email address (if they are under 18). the form will also include a question eliciting interest in participation in the 4-weeks heartfulness program. the program will include tools that promote a heart-based nurturing environment focusing on relaxation, positivity, and developing growth mindsets.

the specific aim of this study is to assess changes in scores measuring symptoms of anxiety using gad-7 (and gad-child), satisfaction with life scale (swls and swls-c), and ucla loneliness scale (version 3).

Eligibility criteria:
inclusion criteria: * high school students (grades 9-12) and staff, aged 14 and above, and willing to participate in the study. exclusion criteria: * non-english speaking high school students and staff and those with mental health diagnoses such as major depressive disorder and anxiety disorders.