Kornimate/medical-research-clean huggingface dataset:
the efficacy of sodium-glucose co-transporter 2 inhibitor or dipeptidyl peptidase-4 inhibitor in type 2 diabetes patients with premix insulin

Conditions: Type2 Diabetes

Summary: the population of type 2 diabetes increased enormously worldwide. as disease progression, uncontrolled type 2 diabetes patients need multiple daily insulin injections, but the risk of body weight gain and hypoglycemia will increase. in recent years, the newly oral anti-hypoglycemic agents developed, such as dipeptidyl peptidase-4 inhibitors (dpp4i) and sodium-glucose co-transporter 2 inhibitors (sglt2i). the former indirectly stimulate insulin secretion and suppress glucagon through increase incretin. the later inhibit re-absorption of blood glucose in proximal renal tubule to improve hyperglycemia. according to the guideline published in 2017 by american diabetes associations, if patients received premix insulin injections twice daily and their glycemic control can't meet the target, increase the frequency of injection such as basal bolus would be considered. however, it is difficult for some patients and it may cause more hypoglycemia and gain of body weight. because previous report revealed dipeptidyl peptidase-4 inhibitors or sodium-glucose co-transporter 2 inhibitors added to insulin resulted in better glycemic control, but there was no direct comparison, so we design this study to observe the efficacy of these two drugs in uncontrolled diabetes patient received twice daily insulin injections.


Eligibility criteria:
inclusion criteria: * type 2 diabetes patient received premix insulin twice daily and hba1c\>7% * \>20 years old exclusion criteria: * type 1 diabetes and gestational diabetes * diabetic ketoacidosis in previous 6 months * urinary tract infection in previous 6 months * pancreatitis in previous 6 months * estimated gfr\<45 ml/min/1.73m2 * patient whom already received dpp4 inhibitor or sglt2 inhibitor

Keywords: sglt2 inhibitor dpp4 inhibitor
hypofractionated radiotherapy versus stereotactic irradiation with hyaluronic acid

Conditions: Prostatic Adenocarcinoma

Summary: the present randomized, open, multicentric phase ii trial, in parallel groups with two arms of treatment, compares the treatment a, moderate hypofractionated radiotherapy of 62gy, to treatment b, stereotactic irradiation of 37.5 gy with hyaluronic acid injection in the space between the prostate and the rectum to preserve the rectal-wall from high doses of irradiation. the study aims to assess the rates of late urinary toxicities of grade ≥ 2 induced by a moderate hypofractionated radiotherapy (62gy in 20 fractions of 3.1gy) and by a stereotactic radiotherapy (37.5gy in 5 fractions of 7.5gy), and the rectal toxicities after an injection of hyaluronic acid between the rectal wall and the prostate. ninety-six patients and 9 centers are included in the protocol.


Eligibility criteria:
inclusion criteria: * age superior or equal to 18 years and inferior to 80 years. * patient with a low- to intermediate-risk prostate cancer, according to d'amico classification, for an exclusive irradiation. * prostate cancer histologically proven. * performance index oms (world health organization) of grade 0-2. * indication of external beam radiotherapy validate by the medical commission of the institution. * ipss (international prostate symptom score \< 15/35 (without alpha-blocker). * the signed consent form. exclusion criteria: * rectal surgery antecedents. * prostate resection less than 6 mois. * involvement of the seminal vesicles or of the capsule on mri. * patient who can't cooperate during the treatment. * pelvic irradiation antecedents. * antecedents of inflammatory intestinal pathologies. * neoplasia. * patients treated with anti-neoplastic or anti-angiogenic or with other treatments used in rheumatology and which may include methotrexate (in order not to have a radiosensitizing effect). * patients receiving anticoagulant treatment. * other undergoing study that may interfere with the present study. * patient under legal protection measure. * hypersensitivity to hyaluronic acid. * patient with auto-immune disease. * patient receiving immunosuppressive medication. * severe allergies. * history of endocarditis.

Keywords: prostate hypofractionated radiotherapy stereotactic irradiation spacer rectal and bladder toxicities
new insights into the metabolic syndrome: the role of alpha defensin

Conditions: Metabolic Syndrome

Summary: the purpose of this study is to find out if there is a connection between a higher level of peptide alpha defensin in blood serum with the metabolic profile of adolescents aged 13-17.


Eligibility criteria:
inclusion criteria: * youths with metabolic syndrome (bmi above 95%) * youths with bmi below 3% exclusion criteria: -
the healthy lifestyles passport program: a nutrition education program to prevent childhood obesity

Conditions: Childhood Obesity

Summary: the purpose of this study is to evaluate the effectiveness of the healthy lifestyles passport program (hlpp) in preventing infant and childhood obesity. it is hypothesized that the participants in the intervention arm will exhibit less excessive weight-for-length gain from 4- to 6-months of age. in 2-years and 5-years, it is predicted that the participants in the intervention arm will yield lower body mass index (bmi) z-scores than the participants in the control arm, who receive usual care.


Eligibility criteria:
inclusion criteria: * pregnant women during the third trimester (\>28 weeks gestation) receiving care in the institution's women's health center * no medical conditions complicating their pregnancy * must be able to communicate in english or spanish * be reachable by phone * plan to be the consistent caretaker of the child at least 75% of the time * plan to attend the institution's pediatric outpatient clinic for the child's routine healthcare exclusion criteria: * child with any disabling or chronic illnesses * any existing and/or pre-existing disabling or chronic illnesses that would qualify the mother as "high risk" * wards of the state * mothers with a disabling/serious chronic illness * drug/alcohol use during pregnancy

Keywords: obesity overweight childhood obesity prevention z score weight for length wfl body mass index bmi prenatal maternal nutrition education health education health literacy health numeracy passport healthy lifestyles growth growth chart
safety and efficacy study of hucns-sc in subjects with neuronal ceroid lipofuscinosis

Conditions: Neuronal Ceroid Lipofuscinosis

Summary: the purpose of this phase ib study is to determine if "human central nervous system stem cells"(hucns-sc) is safe to be transplanted in subjects with infantile and late infantile neuronal ceroid lipofuscinosis. the study will also measure post-transplantation disease progression.

participation in this study will involve screening assessments, surgery to implant hucns-sc, medication to suppress immune system and a series of follow-up assessments.

Eligibility criteria:
inclusion criteria: * age 6 months to 6 years * male or female * clinical diagnosis of infantile neuronal ceroid lipofuscinosis or late infantile neuronal ceroid lipofuscinosis * cln1 or cln2 mutation exclusion criteria: * previously received an organ, tissue or bone marrow transplantation * previously participated in any gene or cell therapy study * infection with hepatitis virus, cytomegalovirus, epstein-barr virus, or human immunodeficiency virus (hiv) * current or prior cancer * bleeding disorder * unable to have an mri scan

Keywords: batten's disease incl lincl neuronal ceroid lipofuscinosis ncl
storage and research use of human bio-specimens from melanoma patients and clinical testing for assignment of treatment

Conditions: Melanoma

Summary: the purpose of this research is to identify biological characteristics occurring in the initiation and progression of melanoma.


Eligibility criteria:
inclusion criteria * pathologically-proven diagnosis of melanoma. * patient must have a test or procedure that has the potential to provide left-over tissue that can be banked for future research purposes or the patient has already had a diagnostic or therapeutic procedure but who has not yet been approached to participate is also eligible. exclusion criteria * any patient with significant contraindications to venipuncture (e.g., severe anemia) will be excluded from blood collection procedures. however, if the patient provides consent and a paraffin-embedded block or 10-15 unstained slides of their tissue diagnosis, they will not be excluded from this protocol. * any patient unable or unwilling to provide consent.
assessment of novel technology to facilitate drainage in ostomy pouches: outflow study

Conditions: Colostomy Stoma; Ileostomy - Stoma

Summary: the overall aim of this study is to determine the performance and safety of a novel coated material inside convatec ostomy pouches, and to explore the clinical and quality of life benefits that may occur with the use of the test product. a minimum of 30 subjects, and a maximum of 40 subjects will be recruited to obtain 30 complete datasets comprised of a minimum of 15 colostomy and minimum of 10 ileostomies.


Eligibility criteria:
inclusion criteria: * • subjects with a colostomy or ileostomy * age 18 years and over * medically stable in the opinion of the investigator * are able and willing to provide informed consent * are able and willing to attend study visits * currently use the same models of pouches as required by the study * have a recent history of frequent pancaking (colostomy patients only) * willing to stop using any lubricants in the pouches whilst participating in the study. * subject has a valid email address for the investigator to send links to study questionnaires and has access to a web enabled device. exclusion criteria: * • subjects with any peristomal skin condition classified as non-intact skin at the time of enrolment * subjects who maybe receiving any concomitant treatment and/or medications which could impact the consistency of effluent during the study period. * allergic to any components of the novel lubricant inclusive of soyabean and/or vitamin e.

Keywords: ileostomy colostomy quality of life
towards the validation of a new blood biomarker for the early diagnosis of parkinson's disease

Conditions: Parkinson Disease

Summary: the investigators have recently discovered a metabolic biomarker which predicts parkinson's disease (pd) at the early stages in patients and in animal models. the aim of biopark is to investigate how the biomarker evolves in advanced pd stage, when diagnosis confirmation is higher, an in de novo pd patients who come from a different geographical area than those of the publication (since it is known that the metabolome is largely influenced by lifestyle). they will also evaluate if the biomarker is able to distinguish patients with a parkinsonian syndrome often confused with parkinson's disease, i.e. multiple system atrophy (msa).

parkinson's disease (pd) affects more than 7 million people worldwide and represents a growing health and socio-economic burden. it is an incurable neurodegenerative disease, and the search for biomarkers that allow reliable early diagnosis and provide new therapeutic targets is essential to find cures for pd. in a recently published preclinical and clinical study, the investigators have identified in 2 rat models of pd and a primate model and in 2 human cohorts from biobanks significant deregulations of 6 serum metabolites: acetoacetate, betaine, beta-hydroxybutyrate, creatine, pyruvate and valine. from these 6 metabolites, they built a composite biomarker, which allowed to classify de novo parkinsonian patients against controls (healthy subjects) with an accuracy (defined as the ratio (correctly classified/total) of 82.6%. this study demonstrated for the first time that a common metabolic dysregulation occurs early in either animal models or in pd patients, thus providing an unbiased diagnostic tool as well as major hypothesis for the understanding of the pathophysiology of the disease and the development of innovative therapeutic approaches. the goal of biopark is to improve the clinical diagnosis of early pd using the blood biomarker. to this end, the investigators will study whether the biomarker is able to differentiate between patients with pd \>5 years and already treated with dopaminergic drugs (thus with a very high diagnostic confirmation) and patients suffering from other neurodegenerative diseases often confused with it, mainly multiple systeme atrophy (msa). furthermore, the investigators hope to confirm the preliminary results on a new cohort of de novo patients. for that aim, they will use the already optimized method for biomarker discovery, i.e. nuclear magnetic resonance (nmr)-based metabolomics on patient serum.

Eligibility criteria:
inclusion criteria: * patients with de novo parkinson's disease, without dopaminergic treatment * patients with advanced parkinson's disease (\> 5years) with dopaminergic treatment * patients with multiple system atrophy exclusion criteria: * patients with deep brain stimulation * other neurodegenerative diseases * patients protected by french law (pregnant or lactating women, prisoners, ...)
laparoscopic management of periappendicular abscess

Conditions: Appendicitis; Abdominal Abscess

Summary: according to retrospective studies the conservative management of periappendicular abscess is associated with decreased complication and re-operation rate compared with open appendectomy. large abscesses require percutaneous drainage. sometimes percutaneous drainage is not possible because of anatomical position of the abscess and surgical treatment is needed. the purpose of this study is evaluate whether laparoscopic appendectomy is suitable for the first-line treatment in patients with periappendicular abscess. the hypothesis of the study is that laparoscopic management of periappendicular abscess is suitable for the first-line treatment and it does not increase time of hospitalization or complication rate compared with conservative management.


Eligibility criteria:
inclusion criteria: * periappendicular abscess at least 2 cm in size exclusion criteria: * missing written informed consent * antimicrobial therapy lasted over 24 hours before randomization * attempt of drainage before randomization * age over 80 years or under 18 years old * pregnancy * allergy to either cefuroxime or metronidazole * severe chronic disease, that substantially increases the risk for operative mortality * previous major intra-abdominal surgery, that may have caused intra-abdominal adhesions * carrier of a resistant bacterial strain * being institutionalized or hospitalized for at least 2 weeks before randomization

Keywords: laparoscopy drainage appendectomy
the impact of late effects after treatment for bladder cancer on quality of life

Conditions: Bladder Cancer

Summary: bladder cancer prognosis, treatment, and subsequent morbidity and mortality vary between the different stages, thus resulting in a different impact on patients' lives. there are some well known late effects of the treatments for bladder cancer, but the knowledge of their impact on patients quality of life is sparse. this study aims to determine the prevalence of late effects impact on quality of life and potential risk factors for impairment.


Eligibility criteria:
inclusion criteria: * patients are eligible if they are referred to a hospital in the central region denmark, due to hematuria between 01/01/2022 and 01/01/2023 * ability to understand written and oral danish exclusion criteria: * known alzheimers disease * diagnosed other causes explaining the hematuria

Keywords: quality of life bladder cancer late effects
microwave ablation with mri-guided sbrt boost in renal cell carcinoma

Conditions: Carcinoma, Renal Cell

Summary: the specific aims of this study are: 1. to determine the safety and feasibility of treating patients with a combination of mri guided stereotactic body radiation therapy and microwave ablation. 2. to assess short and long-term toxicity rates of patients treated with a combined modality approach. 3. to assess local control, survival, and pathologic response to treatment

renal cell carcinoma is traditionally managed via a surgical approach. increasingly, local therapy with radiofrequency and microwave ablation is being utilized as an alternative for patients who may not tolerate a nephrectomy or who refuse one. although local control rates for small lesions are excellent, they drop off precipitously for lesions over 4 cm. furthermore, lesions in critical areas such as the renal hilum may be difficult to treat with this method. stereotactic body radiation therapy (sbrt) has had a long record of treating patients with inoperable tumors in locations such as the lung and central nervous system, and there is increasing evidence that it may be useful for patients with renal cell carcinoma. the recent emergence of mri-guided radiation therapy allows for direct visualization of tumors during treatment, and may potentially allow clinicians to treat tumors more precisely. this phase i study will treat renal cell carcinoma patients using a combination of mri-guided stereotactic body radiation therapy and microwave ablation.

Eligibility criteria:
inclusion criteria: * patients with imaging findings consistent with renal cell carcinoma * deemed medically inoperable per urology evaluation * tumor size \>4cm in largest dimension * ecog performance status of \<2 * signed informed consent document(s) * patients with metastatic disease will not be excluded exclusion criteria: * patients who fail mri screening * pregnant or nursing women * history of prior radiation therapy to the upper abdomen * history of invasive cancer in the last 3 years (except for appropriately treated low-rist prostate cancer, treated non-melanoma/melanoma skin cancer, appropriately treated ductal carcinoma in situ or early stage invasive carcinoma of breast and appropriately treated in-situ/early stage cervical/endometrial cancer) * treatment with a non-approved or investigational drug within 28 days of study treatment
a study of healthy subjects to assess the effect of ly450139 on amyloid beta peptide production rate and or dose response.

Conditions: Alzheimer Disease

Summary: to test that ly450139, a gamma-secretase inhibitor, will reduce the rate of newly synthesize amyloid beta by determining the amount of newly synthesized 13c6 leucine-labeled amyloid beta in lumbar cerebrospinal fluid from ly450139 treated subjects compared with placebo treated subjects.


Eligibility criteria:
inclusion criteria: * healthy volunteers: men within the ages of 21 and 50 exclusion criteria: * have serious or unstable medical conditions * have a history of serious infections affecting the brain or head trauma resulting in protracted loss of consciousness within the last 5 years or multiple episodes of head trauma * have a history of primary or recurrent malignant disease * have a recent laboratory result indicating a clinically significant laboratory abnormality as determined by the investigator * have a history of chronic alcohol or drug abuse within the past 5 years * have a known history of human immunodeficiency virus (hiv), afebrile seizures, or clinically significant multiple drug allergies * are judged clinically by the investigator to be at serious risk for suicide * have electrocardiogram abnormalities obtained at visit 1 that in the opinion of the investigator are clinically significant * use of prescription or over the counter medications that cannot safely be discontinued within 14 days prior to visit 2 * have criteria that would preclude a lp such as allergy to all local anesthetics; have a local infection at the site of the lp or have any medical condition requiring treatment with warfarin or heparin. * have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry. * are investigator site personnel directly affiliated with this study and or immediate families. * are lilly employees
efficacy and safety of switching from anti-c5 antibody treatment to iptacopan treatment in study participants with atypical hemolytic uremic syndrome (ahus)

Conditions: Atypical Hemolytic Uremic Syndrome

Summary: the purpose of this phase 3 study is to evaluate the efficacy and safety of iptacopan upon switching from anti-c5 antibody to iptacopan treatment in study participants with ahus.

the study is designed as a multicenter, single-arm, open label study to evaluate the efficacy and safety of iptacopan upon switching from anti-c5 antibody to iptacopan treatment in participants with ahus. it consists of a screening period of up to 8 weeks followed by a 12-month core treatment period and 12-month extension treatment period. the study will assess the effects of iptacopan on a range of efficacy assessments relevant to ahus.

Eligibility criteria:
inclusion criteria: * male and female adult participants ≥ 18 years of age with diagnosis of ahus for whom etiologies of other types of tma and non-ahus kidney disease have been excluded. * currently on the recommended weight-based dosage regimen of anti-c5 antibody treatment for at least 3 months prior to the screening visit. * clinical evidence of response to anti-c5 antibody treatment (in absence of pe/pi) for at least 3 months prior to entering the screening period as defined by: 1. hematological normalization in platelet count ≥150 x 109/l and ldh below upper limit of normal \[uln\], and 2. stable or improving kidney function as defined by ≤15% increase in serum creatinine. * vaccination against neisseria meningitidis and streptococcus pneumoniae infections is required prior to the start of treatment with iptacopan. * if not received previously or if a booster is required, vaccination against haemophilus influenzae infection, should be given, if available and according to local regulations. exclusion criteria: * history of ahus disease relapse while on anti-c5 antibody treatment. * egfr \< 30 ml/min/1.73m\^2 * active infection or history of recurrent invasive infections caused by encapsulated bacteria, i.e., meningococcus, pneumococcus (eg., n. meningitidis, s. pneumoniae) or h. influenzae. * participants with sepsis or active systemic bacterial, viral (including covid-19) or fungal infection within 14 days prior to study treatment administration. * kidney, bone marrow transplant (bmt)/hematopoietic stem cell transplant (hsct), heart, lung, small bowel, pancreas, liver transplantation or any other cell or solid organ transplantation * female patients who are pregnant or breastfeeding, or intending to conceive during the course of the study * any medical condition deemed likely to interfere with the patient's participation in the study

Keywords: atypical hemolytic uremic syndrome ahus, thrombotic microangiopathy tma
goal-directed fluid resuscitation in acute pancreatitis

Conditions: Acute Pancreatitis

Summary: vigorous fluid resuscitation is currently believed to play a key role in reducing complications associated with acute pancreatitis. however, aggressive fluid replacement can be associated with complications such as pulmonary fluid sequestration. the purpose of this study is to evaluate alternative approaches to early fluid resuscitation for patients with acute pancreatitis.

primary aim: evaluate the impact of a goal-directed fluid resuscitation protocol compared to standard fluid resuscitation on systemic inflammation in patients with acute pancreatitis. secondary aim: evaluate the impact of resuscitation with lactated ringer's compared to normal saline on systemic inflammation in acute pancreatitis.

Eligibility criteria:
inclusion criteria: * acute pancreatitis diagnosed by at least 2 criteria * adult patients at least 18 years of age exclusion criteria: * history of severe cardiovascular, respiratory, renal, hepatic or hematologic/immunologic disease * concurrent metabolic or physiologic derangement requiring specific fluid management * pregnancy * patients transferred from acute care hospital