Kornimate/medical-research-clean huggingface dataset:
the effect of henagliflozin and metformin on myocardial tissue-level characteristics

Conditions: Obesity; Type 2 Diabetes; Sodium-glucose Co-transporter-2 Inhibitor; Myocardial Fibrosis; Magnetic Resonance Imaging

Summary: this is a prospective, randomized, open-label, active drug controlled clinical trial that aims to compare the effects of henagliflozin or metformin on myocardial tissue level characteristics in type 2 diabetes patients with obesity. eligible subjects with type 2 diabetes before randomisation and fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomised in a 1:1 ratio to henagliflozin 10 mg once a day or metformin 1000 mg twice a day and treated for 24 weeks. the study includes five visits.

mri scanning will be assessed at baseline and at the end of the treatment period in order to to assess the cardiac morphology, cardiac function, and myocardial tissue characteristics. the cardiac mri examination will be performed in accordance with a pre-defined mri protocol. images from all sites will be analyzed centrally at the core-lab using a dedicated software package and certified analysts.

Eligibility criteria:
inclusion criteria: * individuals with type 2 diabetes newly diagnosed based on the who (1999) criteria; * hemoglobin a1c levels \>=7.0% and \<=8.0%; * females or males ≥18 years up to 75 years of age. exclusion criteria: * females or males \<18 years. * clinical diagnosis of type 1 diabetes and other types of diabetes. * blood pressure at screening that would require a change in blood pressure treatment over the study period. * history of stroke or other clinically significant cerebrovascular disease. * any of the following cardiovascular diseases: 1. atrial fibrillation, or other unstable or severe arrhythmia affecting heart function 2. unstable heart failure or any heart failure with nyha class iii and iv 3. significant valvular disease 4. significant peripheral artery disease * active malignancy requiring treatment at the time of visit 0. * patients with severe hepatic impairment. * unstable or rapidly progressing renal disease. * ongoing treatment with loop diuretics. * estimated glomerular filtration rate (egfr) \<45 ml/min/1.73 m2. * women who has a positive pregnancy test at enrolment or randomization, or are breastfeeding.

Keywords: metformin
an observational study to assess ubrogepant tablets and atogepant tablets to treat migraine in adult participants

Conditions: Migraine

Summary: migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. this study will evaluate how effective the use of ubrogepant and atogepant is in treating adult participants with migraine. urogepant (ubrelvy) and atogepant (qulipta) are approved drugs for treatment of migraine in adults in the us. approximately 200 adult participants who are prescribed ubrogepant or atogepant by their doctors will be enrolled in this study in israel. participants will receive ubrogepant oral tablets or atogepant oral tablets as prescribed by their physician. participants will be followed for 90 days. there is expected to be no additional burden for participants in this trial. participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of migraine according to the ichd-3 upon judgement of the treating physician * the patients should be naive to the designated treatment * ability to fill an e-diary app exclusion criteria: * patients who cannot be treated with ubro or ato according to the applicable approved label * patients participating in a concurrent clinical interventional study or within the last 30 days * patients who were previously treated with rimegepant will be excluded from the study

Keywords: migraine ubrogepant ubrelvy atogepant qulipta
efficacy of supplementation with probiotics as adjuvant to mechanical treatment in chronic periodontitis

Conditions: Probiotics, Periodontitis

Summary: it aims to demonstrate the superiority of a 6-week supplementation with lactibiane buccodental compared to placebo, as adjunctive therapy in chronic periodontitis in patients with generalized chronic periodontitis


Eligibility criteria:
inclusion criterion: * age ≥ 18; * patient with moderate to severe chronic periodontitis (mean attachment loss ≥ 3 mm), generalized (more than 30% of sites with loss of attachment), with presence of at least one of three bacterial species the red complex (either pg, tf or td), which, according to the practitioner, may be the result of mechanical treatment (ultrasonic debridement); * patient able and willing to participate in the research by complying with the procedures of the protocol especially concerning the consumption of the product under study and having served it by signing a dated informed consent form; criteria of non-inclusion: * patient with acute oral lesions or necrotizing ulcerative periodontitis; * patient who has taken antibiotics in the last 3 months, or who has received treatment affecting periodontal tissue in the past month, or on immunosuppressive therapy (ciclosporin), antihypertensive (nyfedipine), antiepileptic (phenytoin), under biotherapy, or under treatment of hyposialie; * patient with a medical history or current pathology that, in the opinion of the investigator, is likely to interfere with the results of the study or to expose him / her to additional risk: unbalanced diabetes, rheumatic fever, disease affecting renal or hepatic function, neurological deficiency, immunological disease; * patient smoking more than 10 cigarettes a day; * patient with known allergy to at least one of lactibiane buccodental® ingredients; * pregnant or breastfeeding woman or intending to start a pregnancy within 3 months; * a woman who is in a state of childbearing not covered by an active method of contraception; * patient with a psychological or linguistic disability to understand and sign informed consent, or to understand and implement the constraints of the study; * patient participating in another clinical trial, or at the time of exclusion from another clinical trial; * patient under legal protection (tutorship, guardianship) or deprived of his rights following the administrative or judicial decision. * patient not affiliated to a social security scheme
study evaluating the tolerance and biologic activity of oral ciclopirox olamine in patients with relapsed or refractory hematologic malignancy

Conditions: Hematologic Malignancy; Acute Lymphocytic Leukemia; Chronic Lymphocytic Leukemia; Myelodysplasia; Acute Myeloid Leukemia; Chronic Myelogenous Leukemia; Hodgkin's Disease

Summary: this is an open-label, single arm study. approximately 3-30 patients will be enrolled. patients will receive oral ciclopirox olamine (aqueous suspension), initial starting dose of 5 mg/m2/day administered as a single dose daily for 5 days. three patients will initially be treated at each dose level in sequential cohorts. dose escalation will continue for each subsequent cohort based on toxicity and plasma drug concentrations observed during the previous cohort. dose escalation will continue until establishment of the maximum tolerated dose (mtd) has been met. patients who have demonstrated response to treatment, up to 6 total cycles of treatment may be administered. if additional cycles are warranted, ciclopirox olamine will be given at the same dose and frequency as the patient initially received.


Eligibility criteria:
inclusion criteria: 1. age \> 18 2. relapsed or refractory hematologic malignancies including aml, all, cll, high risk myelodysplasia (international prognostic score \>2.5), cml blast crisis, multiple myeloma, non-hodgkin's lymphoma, and hodgkin's lymphoma for which all potentially curative therapy options have been exhausted. 3. ecog (eastern cooperative oncology group) performance status \< 2. 4. biochemical values within the following range: 1. serum creatinine \< 2x upper limit of normal. 2. total bilirubin \< 2x upper limit of normal, ast (asparatate aminotransferase) and alt (alanine aminotransferase) \< 5x upper limit of normal. 5. ability to maintain adequate oral intake of medication. 6. ability to understand and sign informed consent. 7. toxicity from prior chemotherapy has resolved exclusion criteria: 1. uncontrolled systemic infection. 2. uncontrolled intercurrent illness 3. pregnant or breast feeding 4. active cns (central nervous system) disease 5. neurologic symptoms related to intracurrent illnesses or unexplained causes 6. psychiatric illness that would limit compliance with study 7. receiving other systemic chemotherapy, other than hydroxyurea to control circulating blast counts, within 10 days of study entry. hydroxyurea is permitted, however the dose must be stable and unchanged in the 7 days prior to initiation with ciclopirox olamine 8. concurrent therapy with topical ciclopirox olamine. 9. use of other investigational anti-cancer therapy within two weeks of study entry. 10. use of oral or intravenous metal supplements including iron, copper, zinc and nickel. 11. resting ejection fraction \< 50%

Keywords: relapsed and refractory hematologic malignancy all (acute lymphoid leukemia) cll (chronic lymphoid leukemia) high risk myelodysplasia (mds) with an ipss (international prognostic scoring system) score >2.5 cml (chronic myelogenous leukemia) blast crisis relapsed or refractory acute myeloid leukemia (aml)
the role of microsurgery in surgical treatment of varicocele.

Conditions: Varicocele; Infertility

Summary: this study is to set the place of microsurgery in surgical treatment od varicocele in infertile male. fourty patients will undergo microsurgical subinguinal varicocelectomy while the control group consisting of 20 patients wil undergo laparoscopic varicocelectomy.


Eligibility criteria:
inclusion criteria: * clinical varicocele * infertility duration of min one year * poor semen quality * otherwise unexplained infertility in the couple exclusion criteria: * female infertility
comparison of the effect of two treatments on the nutritional and micronutrient status of malnourished children

Conditions: Malnutrition

Summary: the purpose of this study is to measure the impact of a fortified food on the nutritional and micronutrient status of malnourished children, compared with milk. the changes to be evaluated include the indicators weight for height, height for age, weight for age, mid-arm circumferance for age; and levels of hemoglobin, serum zinc, serum ferritin, serum folic acid, erythrocyte folic acid, serum vitamin b12, and urinary iodine.

chronic malnutrition evidenced by short height for age is a common nutritional problem in underdeveloped countries which is generally accompanied by iron deficiency anemia and zinc deficiency. it has many consequences on the adult including limited capacity to work and higher risk of obesity and chronic disease. the present study will offer a fortified food, culturally accepted and locally produced. the effectiveness of this fortified food compared to lactose-free milk, in a controlled dose and with no risk to the health of the study participants, will be determined. both will be distributed for free to be consumed as an atole or in liquid form, respectively, at a community level in an environment controlled as much as possible. this will allow to determine adherence, acceptability, consumption and distribution within the family.

Eligibility criteria:
inclusion criteria: * some degree of malnutrition according to weight for height or height for age * reside in one of the six communities chosen for the study exclusion criteria: * leukemia * diabetes * handicap * down syndrome * renal failure
androgen deprivation therapy for oligo-recurrent prostate cancer in addition to radiotherapy

Conditions: Prostate Cancer

Summary: the overall aim of this project is to test the hypothesis that the addition of adt to metastasis-directed radiotherapy (mdrt) in well-selected pca patients with oligo-metastatic disease prolongs the metastases progression-free survival (mpfs) compared to mdrt alone.


Eligibility criteria:
inclusion criteria: 1. histologically proven initial diagnosis of adenocarcinoma of the prostate. 2. biochemical recurrence of prostate cancer following primary local prostate treatment (radical prostatectomy, primary radiotherapy or radical prostatectomy +/- prostate bed adjuvant salvage radiotherapy) according to the eau guidelines 2018. bcr after surgery: psa \> 0.1ng/ml. bcr after radiotherapy: psa nadir +2 ng/ml or 3 consequent rises in psa level (after exclusion of possible bounce effect). 3. minimal 1 lesion and maximum 4 lesions (bone + lymph nodes) in total, without evidence of visceral metastases. 1. nodal relapse (n1) in the pelvis on psma-pet/ct with a maximum of 4 positive lymph nodes. the upper limit of the pelvis is defined as the aortic bifurcation. 2. nodal relapse (m1a) on psma-pet/ct above the aortic bifurcation with a maximum of 3 positive lymph nodes. 3. bone relapse on psma-pet/ct with a maximum of 3 lesions. 4. combination of a, b, c with a maximum of 4 metastases. 4. age \> 18 years. 5. recent psma-pet/ct scan within 60 days prior to randomization. 6. psa \< 10 ng/ml. 7. in case of chronic use of finasteride the psa value should be \< 5 ng/ml. 8. who performance state 0-2. 9. signed informed consent prior to registration/randomization. exclusion criteria 1. visceral metastases. 2. psa ≥ 10 ng/ml. 3. psa-doubling time ≤ 3 months. 4. adt or chemotherapy for recurrent pca. 5. testosterone \< 1.7 nmol/l 6. painful metastases needed pain medication (\> level 1 pain medication) . 7. invasive active cancers other than superficial non-melanoma skin cancers. 8. inability or unwillingness to understand the information on trial-related topics, to give informed consent or to fill out qol questionnaires.

Keywords: prostate cancer oligometastasis stereotactic body radiation therapy androgen deprivation therapy biochemical recurrence psma pet/ct metastases-directed radiotherapy metastases progression-free survival
a clinical study to test the safety, exposure, and pharmacodynamic markers of csl311 in patients with mild-to-moderate asthma and in healthy volunteers

Conditions: Asthma

Summary: this is a phase 1, first-in-human (fih), multi-center, randomized, double-blind, placebo-controlled study of csl311 in patients with mild-to-moderate asthma. the primary objective of this study is to assess the safety and tolerability of single ascending doses (sad) and multiple ascending doses (mad) of csl311.


Eligibility criteria:
inclusion criteria: * male or female subjects 18 to 65 years of age with diagnosis of mild-to-moderate asthma for parts a and b. for part c healthy, male or female subjects 18 to 50 years exclusion criteria: * oral/parenteral corticosteroids or anti-interleukin-6 therapy within 6 months prior to screening, or any prohibited therapies prior to screening. * history or presence of clinically significant hypertension or other significant cardiovascular abnormality. * any clinically significant abnormality on electrocardiogram at screening. * parasitic infestation within 6 months before screening, or travel or intention to travel to a country with a high prevalence of such infections within 1 year before screening or within 85 days after the last dose of csl311. * occurrence of asthma exacerbation and/or upper/lower respiratory tract infection, or any acute infection or disease within the last 6 weeks before screening.
retrospective evaluation of the impact of epidural on the risk of postpartum hemorrhage

Conditions: Postpartum Hemorrhage

Summary: postpartum hemorrhage (pph) is a major complication of childbirth. epidurals are often implicated in the onset of postpartum hemorrhages. given the paradoxical data in the literature, the investigators wished to retrospectively evaluate the impact of epidurals on the risk of pph, instrumental delivery and the occurrence of pph risk factors. the investigators retrospectively analyzed 5753 records of patients who gave birth vaginally at brugmann university hospital between january 1, 2020 and december 31, 2021. the primary objective was to assess whether epidurals pose a risk of postpartum hemorrhage. secondly, the investigators assessed whether epidurals pose a greater risk of instrumentation of delivery and emergence of pph risk factors.


Eligibility criteria:
inclusion criteria: * patients who gave birth vaginally at the brugmann university hospital horta site between january 1, 2020 and december 31, 2021. exclusion criteria: * patients who gave birth before 25 weeks. * patients who gave birth outside of hospital. * patients who had recourse to a medical termination of pregnancy (mtp). * patients who gave birth by cesarean section.

Keywords: epidural anesthesia postpartum hemorrhage obstetric analgesia neuraxial anesthesia instrumental delivery obstetrical trauma
camrelizumab plus apatinib as maintenance therapy in extensive-stage small-cell lung cancer

Conditions: Small Cell Lung Carcinoma

Summary: this single-arm, phase ii study was designed to evaluate the safety and efficacy of camrelizumab (anti-programmed death-receptor 1 \[pd-1\] antibody) combination with apatinib in participants with es-sclc who was response or stable disease after firstline standard chemotherapy. participants will be receive camrelizumab +apatinib on 21-day cycles until progressive disease (pd) as assessed by the investigator using response evaluation criteria in solid tumors version 1.1 (recist v1.1). treatment can be continued until persistent radiographic pd or symptomatic deterioration.


Eligibility criteria:
inclusion criteria: * male or female patients aged 18 and 75 years old; * signed the informed consent form prior to patient entry; * eastern cooperative oncology group performance status of 0 or 1; * expected survival time: over 3 months; * pathological or cytologically proven extensive-stage small cell lung cancer(according to veterans administration lung study group)and without progression after cycles 4-6 21-day cycles of first-line standard chemotherapy(evaluation was cr /pr/sd based on recist1.1); * if prophylactic cranial irradiation (pci) was not planned,informed consent was required to be written between 3 weeks and 5 weeks after day 1 of the last cycle of chemotherapy. if pci was planned or already performe, informed consent was required to be written between 3 weeks and 8 weeks after day 1 of the last cycle of chemotherapy. exclusion criteria: * has prior therapy with anti-programmed cell death (pd)-1, anti-pd-l1,anti cytotoxic t lymphocyte-associated antigen(ctla)-4 or other drugs that target t cells; * has prior therapy with angiogenesis inhibitors,such as sunitinib, bevacizumab, apatinib, anlotinib; * has active or untreated central nervous system (cns) metastases and/or cancerous meningitis; * imaging (ct or mri) shows that tumor invades large blood vessels or the boundary with blood vessels is unclear; * has spinal cord compression which was not cured or relieved through surgery and/or radiotherapy, or diagnosed spinal cord compression after treatment showed no clinical evidence of disease stabilization prior to allocation ≥1 week; * within the past 2 weeks have used high dose antibiotics; * according to the judgement of the researchers, there are other factors that may lead to the termination of the study.

Keywords: maintenance camrelizumab plus apatinib
clinical study on the intervention of xuesaitong soft capsules in post-intervention patients with acute coronary syndrome and clinical research protocol

Conditions: Acute Coronary Syndrome

Summary: to assess the effects of xuesaitong soft capsules on platelet function, clinical efficacy, prognosis, and safety in the treatment of acute coronary syndrome, 400 patients with acute coronary syndrome who underwent pci were treated with xuesaitong soft capsules (mainly containing ginsenosides) for 12 weeks.


Eligibility criteria:
inclusion criteria: 1. patients diagnosed with acute st-segment elevation myocardial infarction, acute non-st-segment elevation myocardial infarction, or unstable angina according to western medical standards. inclusion criteria. 2. within 4 weeks post-pci. 3. aged between 18 and 80 years, both male and female. 4. voluntarily participating in the clinical trial, having signed the informed consent form. exclusion criteria: 1. uncontrolled hypertension after medication (systolic bp \>180mmhg or diastolic bp \> 110mmhg). 2. increased bleeding risk: history of hemorrhagic stroke; intracranial aneurysm; major trauma or surgery within the past month (including exclusion criteria bypass surgery); active bleeding disorders. 3. history of gastrointestinal ulcers or significant gastrointestinal bleeding. 4. severe organic heart disease, such as lvef \< 35% or nyha/killip heart function grade iv. 5. history of malignant arrhythmias within the past year (arrhythmias affecting hemodynamics requiring medication or electrical cardioversion, or requiring cpr), congenital heart disease, or malignant tumors. 6. severe liver or kidney dysfunction: alt or ast ≥ 3×uln, tbil≥ 2×uln, or creatinine clearance \< 30ml/min. 7. pregnant or lactating women. 8. recent blood donation or significant blood loss within the past 3 months (≥400ml). 9. history of alcohol abuse (≥28 standard units/week for males, ≥21 standard units/week for females) or frequent alcohol consumption in the past 6 months (≥14 standard units/week). 10. history of drug abuse or dependence within the past year. participation in other clinical trials and taking trial drugs within the past 3 months. 11. allergy or intolerance to aspirin or p2y12 receptor inhibitors. 12. allergy to any components of the trial drug. 13. other conditions deemed inappropriate for participation by the nvestigator

Keywords: acute coronary syndrome traditional chinese medicine total saponins of panax notoginseng
effect and safety of detrol la in men with overactive bladder symptoms with or without bladder outlet obstruction

Conditions: Urinary Incontinence

Summary: the primary objective of the trial is to evaluate the effect of tolterodine er plus tamsulosin versus placebo on patient perception of overall treatment benefit in men who have frequency and urgency, with or without urinary urge incontinence (uui), with or without bladder outlet obstruction (boo).


Eligibility criteria:
inclusion criteria: * male 40 years of age * clinical signs and symptoms of frequency and urgency, with or without uui, with or without boo, for at least three months * mean urinary frequency of 8 micturitions/24h verified by the screening micturition diary exclusion criteria: * post-void residual urine volume (pvr) of \> 200 ml as measured by an ultrasound * maximum urinary flow rate (qmax) of \< 5 ml/second as measured by a flowmeter; a voided volume of 75 ml is required in order to accurately record the qmax * prescribed and administered an antimuscarinic or antispasmodic within 1 month * prescribed and administered an a-1-adrenergic antagonist within 2 weeks
comparison of sevoflurane and isoflurane anesthesia for benign breast tumor excision

Conditions: Breast Neoplasms

Summary: generally, benign breast tumors are excised under the local anesthesia. but such action was so invasive that every patient would experience the physiological and psychological stimuli unavoidably. sevoflurane was advised as a better inhalational anesthesic for its "easy come,easy go" property during short-lasting operations than isoflurane. we purposed that sevoflurane would be a superior anesthesic for benign breast tumor excision than isoflurane with relative less alteration in hemodynamics, less postoperative side effects and easily-control the depth of anesthesia.


Eligibility criteria:
inclusion criteria: * chinese * diagnosed benign breast tumor patients * 18-64 yrs exclusion criteria: * allergic to any interventional drugs * organic dysfunction * long-lasting pacu staying

Keywords: sevoflurane isoflurane breast tumor anesthesia