Kornimate/medical-research-clean huggingface dataset:
mk-0431/ono-5435 phase iii clinical trial - insulin add-on study for patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: this phase iii clinical trial will examine the efficacy, safety, and tolerability of the addition of mk-0431/ono-5435 to japanese patients with type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy and insulin monotherapy.


Eligibility criteria:
inclusion criteria: * japanese patients with type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy and insulin monotherapy exclusion criteria: * patients with type 1 diabetes mellitus

Keywords: mk-0431/ono-5435 type 2 diabetes mellitus
twice-per-weekselinexor, 2 days melphalan

Conditions: Acute Myeloid Leukemia

Summary: twice-per-week selinexor, 2 days melphalan plus bu2flu3 compared with bu3flu5 for elder high-risk acute myeloid leukemia undergoing allogenic hematopoietic cell transplantation: a multi-center randomized phase 3 trial

twice-per-week selinexor, 2 days melphalan plus bu2flu3 compared with bu3flu5 for elder high-risk acute myeloid leukemia undergoing allogenic hematopoietic cell transplantation: a multi-center randomized phase 3 trial primary objective the primary objective of this study is to compared 1-year rfs between sel2mel2bu2flu3 and bu3flu5 groups for elder aml in crc undergoing allo-hct. secondary objective the secondary objective of this study is to compare leukemia relapse, engraftment, gvhd, os, trm, aes and rrt between sel2mel2bu2flu3 and bu3flu5 groups

Eligibility criteria:
inclusion criteria: * 1. patients with high-risk acute myeloid leukemia (excluding acute promyelocytic leukemia). 2. recipients of allogeneic hematopoietic stem cell transplantation (including hla-matched or mismatched allogeneic transplantation as well as unrelated donor transplantation). 3. age ≥ 55 years. 4. disease status prior to allogeneic transplantation must be complete remission (crc), confirmed by bone marrow analysis within three days prior to randomization. 5. karnofsky performance score (kps) of at least 60. 6. informed consent must be signed prior to the commencement of the study procedures. if the patient's signature would be detrimental to their treatment due to their medical condition, the informed consent may be signed by a legal guardian or an immediate family member of the patient. note: \*high-risk aml: ① patients classified as high-risk according to the eln 2022 grading criteria. ② aml patients with persistent mrd positivity prior to transplantation. ③ patients with refractory or relapsed aml. exclusion criteria: * 1. previous history of hematopoietic stem cell transplantation. 2. active cardiac disease, defined as one or more of the following: 1. history of uncontrolled or symptomatic angina. 2. myocardial infarction within the last 6 months prior to study enrollment. 3. history of arrhythmias requiring medication or with clinically significant symptoms. 4. uncontrolled or symptomatic congestive heart failure (nyha class \> 2). 5. ejection fraction below the lower limit of the normal range. 3. respiratory failure (pao2 ≤ 60 mmhg). 4. liver dysfunction (total bilirubin ≥ 3 mg/dl, transaminases \> twice the upper limit of normal). 5. renal dysfunction (creatinine clearance rate \< 30 ml/min). 6. presence of psychiatric disorders or other conditions that prevent cooperation with the study treatment and monitoring requirements. 7. ecog performance status of ≥ 4. 8. uncontrolled or active infection. 9. any condition that impairs the ability to provide informed consent. 10. any conditions deemed unsuitable for enrollment by the investigator prior to randomization.

Keywords: allogeneic hematopoietic stem cell transplantation
evaluation of stendo pulsating suit on microcirculation and endothelial function in diabetic patients

Conditions: Type 2 Diabetes

Summary: the action of one stendo pulsating suit session will be evaluated on 16 type 2 diabetic patients referred on the diabetic consultations. the effects of one stendo pulsating suit session system will be assessed on the peripheral cutaneous microcirculation and on endothelial functions

the role of the endothelium in micro-vascular system is mediated by synthesis and release of numerous substances that act on the smooth muscle fibers. the release of these products is modulated, in turn, by various circulating molecules, by autonomic nervous system and by local mechanical factors such as shear stress. the type 2 diabetes leads to early vascular redesign with the onset of endothelial dysfunction and the worsening of the arterial stiffness. these anomalies, well correlated with the cardiovascular risks, are currently investigated in the department of endocrinology, diabetes, and nutrition at the jean verdier hospital. the analysis methods allow identifying early modifications in response to various drugs, nutritional or physical stimuli. the aim of this study is therefore to evidence a peripheral microcirculation and endothelial function improvement in type 2 diabetic patient in comparison to a cross-over control session.

Eligibility criteria:
inclusion criteria: * type 2 diabetic patient * diagnosis of diabetes \> 1 year * hba1c between 6 and 8,5 * treated with oral anti-diabetic, insulin and/or incretins which can be stayed unchanged during the 2-week study exclusion criteria: * type 1 diabetic patient * antecedent of cardiomyopathy, cardiac ischemia or valvulopathy * severe kidney failure * non controlled hypertension (\> 160/100mm hg) * cardiac arrhythmia * severe respiratory failure * patient with an advanced obstructive arterial disease * patient with a recent and progressive deep venous thrombosis

Keywords: type 2 diabetes ; endothelium stimulation
analysis of biologic signatures in crohn's patients undergoing surgery

Conditions: Crohn Disease

Summary: the purpose of this study is to compare the effect of two procedures - the kono-s procedure and the side-to-side functional end to end anastomosis - on the microbiome (the bacteria that live in our gut) and on the intestinal immune system. the investigators are hypothesizing that there are differences in the microbiome environment and the immune environment between the two procedural groups.

these are two are different ways to re-connect the intestines after a portion of it is removed during surgery. patients will be randomly assigned to either be re-connected with a procedure called the kono-s anastomosis or with a side-to-side anastomosis during their surgery. this study will look at the microbiome and immune environment in the piece of intestine that is removed during surgery. then, at the follow colonoscopies (3-6 month, 12-18 month, 60 month), biopsies (small pieces of tissue) will be taken near the connection between the small intestine and colon. this will be used to see how the microbiome and immune system in that area changed since the surgery. genetic tests will be used to measure the microbiome and the levels of immune proteins in the intestines.

Eligibility criteria:
inclusion criteria: 1. patients with crohn's ileitis/ileocolitis requiring surgical resection or patients previously enrolled in the "kono-s anastomosis versus side-to-side functional end anastomosis in the prevention of post-operative recurrence of crohn's disease (wc irb #1303013645)" trial. 2. patients age 18 years and older. 3. all phenotypes will be included: nonstricturing nonpenetrating (b1), stricturing (b2), and penetrating (b3) according to the vienna classification. 4. patients will be included regardless of preoperative medications (untreated, steroids, biologics) exclusion criteria: 1. patients under 18 years of age. 2. pregnant patients. 3. patient does not speak english 4. patients that may need a different surgical procedure as per the surgeon at the time of intraoperative evaluation
ai-based multi-center research on identification/classification/aided diagnosis of mood disorder

Conditions: Bipolar Disorder Depression; Major Depression

Summary: at present, diagnosis and recognition of depression and bipolar disorder are mainly based on subjective evidence such as clinical interview and scale evaluation. the corresponding diagnosis basis has some shortcomings, such as poor diagnostic reliability and failure in early identification of bipolar disorder. therefore, it is of great significance to explore objective diagnostic indicators to remedy the deficiencies. therefore，the investigators collect psychological and physiological information data of patients with bipolar disorder and depression.then the investigators aim to construct and verify the multidimensional emotion recognition model to analyze the personality characteristics, negative emotions and cognitive reactions of different individuals, and form a systematic accurate recognition and evaluation tool.


Eligibility criteria:
inclusion criteria: 1. age 15-55, regardless of gender; 2. the brief international neuropsychiatric interview chinese version (mini) was used to meet the diagnostic criteria for dsm-iv-tr depressive disorder or bipolar disorder (type i); 3. total score of hamilton depression scale (hamd-17) ≥17, and young's manic scale (ymrs) ≤6; 4. junior high school or above. exclusion criteria: 1. the patient conforms to dsm-iv schizophrenia and related spectrum disorders. 2. the patient has a history of severe head trauma (loss of consciousness for more than 5 minutes), current or previous history of epilepsy, intracranial hypertension, or other serious neurological diseases; 3. had a history of alcohol or psychoactive substance abuse/dependence in the 6 months prior to the test; 4. those considered unsuitable for inclusion by the researcher.

Keywords: bipolar disorder depression major depression machine learning skin potential micro-facial expression electroencephalogram
validity of a test of functional cognition in persons with acquired brain injury

Conditions: Acquired Brain Injury

Summary: the purpose of this study is to test the validity of the weekly calendar planning activity (wcpa), a test of functional cognition in persons with acquired brain injury. we will formally examine the utility, baseline profile and validity of the wcpa with adults ages 21 and above with acquired brain injury for both the wcpa 17 and wcpa 10 versions.

the purpose of this study is to test the validity of the weekly calendar planning activity (wcpa), a test of functional cognition in persons with acquired brain injury. we will formally examine the utility, baseline profile and validity of the wcpa with adults ages 21 and above with acquired brain injury for both the wcpa 17 and wcpa 10 versions. the weekly calendar planning activity (wcpa) is a performance-based cognitive instrumental activities of daily living (c-iadl) task that requires working memory, planning, shifting, inhibition, and self-monitoring. the wcpa requires the examinee to input a series of 10 appointments, into a mock weekly calendar/schedule while following multiple rules, managing appointment conflicts, ignoring distracting questions by the examiner and keeping track of time. the wcpa is used routinely by occupational therapists for those with acquired brain injury, during their stay on the inpatient rehabilitation unit, prior to discharge as a measure of iadl. persons who are currently receiving occupational therapy and would typically be given the wcpa within the course of routine occupational therapy, will be asked for permission to include their results within a database for the project. persons who are alert, oriented x3, able to attend for at least 10 minutes, are able to read and write legibly in english would typically be administered the wcpa. potential participants will be identified by their primary therapist. if the person does not provide consent, the wcpa will be administered as part of usual care but the results will not be included within the project.

Eligibility criteria:
inclusion criteria: * able to attend for at least 10 minutes * able to read and write legibly in english
bloom: behavioral modification and lorcaserin for overweight and obesity management

Conditions: Obesity

Summary: the purpose of this study is to assess the weight loss effect of lorcaserin at the end of the first year of treatment (week 52) and to assess the ability of lorcaserin to maintain weight loss at the end of the second year of treatment (week 104)


Eligibility criteria:
inclusion criteria: * obese adults with a bmi 30 to 45 kg/m2 or overweight adults with a bmi 27 to 29.9 kg/m2 and at least one obesity-related comorbidity (hypertension, dyslipidemia, cardiovascular disease, glucose intolerance, sleep apnea) * ability to complete a 2 year study exclusion criteria: * diabetes * pregnancy * history of heart valve disease * serious or unstable current or past medical conditions

Keywords: obesity weight loss lorcaserin apd356 bloom hypertension dyslipidemia sleep apnea glucose tolerance cardiovascular disease arena
safety and pharmacokinetics of fluzoparib in healthy subjects and those with impaired kidney function

Conditions: Renal Impairment

Summary: the primary objective is to evaluate pharmacokinetics of fluzoparib and its main metabolite in subjects with impaired kidney function in comparison with healthy subjects, to develop dose recommendations for patients with renal impairment. the secondary objective is to evaluate the safety of fluzoparib in subjects with mild and moderate renal impairment and in healthy subjects.


Eligibility criteria:
inclusion criteria: - inclusion criteria for subjects with impaired kidney function: 1. sign the informed consent before the trial, and fully understand the content, process, and possible adverse reactions of the trial; 2. male or female subjects aged 18 to 70 (including 18 and 70); 3. body mass index (bmi) ranges from 18 kg/m2 to 28 kg/m2 (including 18 and 28); 4. the glomerular filtration rate should meet the following criteria (gfr, ml/min):subjects with mild renal impairment (ckd2): 60-89 ml/min (including 60-89);subjects with moderate renal impairment (ckd3): 30-59 ml/min (including 30-59 ends); 5. renal function should be stable, and the gfr results should be tested twice before administration (at least 3 days apart) within the same ckd stage. inclusion criteria for subjects with normal kidney function: 1. sign the informed consent before the trial and fully understand the content, process, and possible adverse reactions of the trial; 2. male or female subjects aged 18 to 70 (including 18 and 70); 3. body mass index (bmi) ranges from 18 kg/m2 to 28 kg/m2 (including 18 and 28); 4. glomerular filtration rate (gfr) ≥90 ml/min. exclusion criteria: - exclusion criteria for subjects with impaired kidney function: 1. history of kidney transplant; 2. need renal dialysis during the study; 3. urinary incontinence or anuria; 4. clinically significant heart disease, including but not limited to: congestive heart failure, symptomatic coronary artery disease, myocardial infarction, qtcf≥470 ms (female) or qtcf≥450 ms (male) within 12 months before the start of treatment; 5. received any investigational drug within 3 months before the study started; 6. taking any drugs which can affect the metabolic enzyme cyp3a within 14 days before the study started; 7. smokers and alcoholics, or those screened positive for alcohol; 8. history of drug use, or drug abuse screening positive. exclusion criteria for subjects with normal kidney function: 1. history of kidney transplant; 2. clinically significant heart disease, including but not limited to: congestive heart failure, symptomatic coronary artery disease, myocardial infarction, qtcf≥470 ms (female) or qtcf≥450 ms (male) within 12 months before the start of treatment; 3. received any investigational drug within 3 months before the study started; 4. taking any drugs which can affect the metabolic enzyme cyp3a within 14 days before the study started; 5. smokers and alcoholics, or those screened positive for alcohol; 6. history of drug use, or drug abuse screening positive.
treatment outcomes with full arch rehabilitations retained by immediate or conventionally loaded implants

Conditions: Edentulous Jaw; Missing Teeth

Summary: this study aims to assess the treatment outcomes (clinical, functional and subjective) of full arch rehabilitations supported by implants with or without an immediate loading protocol. in this randomized clinical trial 20 fully edentulous patients were treated with full arch rehabilitations on dental implants. in half of the sample, the implants were loaded immediately by means of abutments after emplacement of the implant; but in the counterparts these abutments were connected to implants two months after the surgery (conventional protocol), and until that time the dentures were retained by healing abutments. treatment outcomes were assessed at 2, 6 and 12 months after surgery. clinical outcomes were quantified on the basis of implant failure rate, marginal bone loss and the peri-implant gingival index. functional outcomes were calculated according to masticatory performance, estimated by the mixed fraction of a two-coloured chewing gum after 5, 10 and 15 chewing strokes, by the occlusal force recorded by pressure-sensitive sheets and by the bioelectrical muscular activity. the subjective outcomes of the treatment were assessed using both the oral satisfaction scale (visual analogue scale) and the spanish version of the oral health impact profile (ohip-20).


Eligibility criteria:
inclusion criteria: * completely edentulous individuals who had lacked teeth for more than 10 years, routine users of conventional complete prostheses. * sufficient amount of remaining bone to receive the implants in the region of the mandibular canines (minimum height=15 mm/minimum ridge width= 5mm) * no evidence of systemic or psychic pathology that might contraindicate the implant treatment. exclusion criteria: * those in which oral surgery or cognitive evaluations are contraindicated
study of decreasing kinetics of the leptospiremia during antibiotic treatment of leptospirosis in martinique

Conditions: Leptospirosis

Summary: the leptospirosis evolves on an endemic mode in french west indies and its incidence in 2011 was de 61/100 000 inhabitants, 100 times more than the metropolitan france's incidence (0,47/100 000). if cases can arise all year long, periods of heavy rainfall are associated with the arisen of epidemic peaks clinical presentation of leptospirosis include a wide range of symptoms: the most frequent form is a flu-like syndrome but more severe forms are described as meningitis, uveitis and classical severe presentation such as lung bleedings and liver-kidneys infringement (syndrome of weil) which constitute the most severe forms of the disease. currently , polymerase chain reaction (pcr) is the only test who can provide a diagnostic confirmation during the first week of development and before the appearance of the first antibody. if the microagglutination test (mat) is considered the gold standard test for diagnosis of leptospirosis. however it requires rending samples to the referent national center for the leptospirosis at pasteur institute in paris while the antibodies do not appears until the second week of illness. a second sample is required 15 days after the first one, to confirm the diagnosis. in clinical practice , the technique of real-time pcr for the detection and quantification of pathogenic leptospira during the first week of illness . the technique of diagnosis of leptospirosis by real-time pcr has been implemented and tested in 2007 at the university hospital of martinique and providing to the clinicians from 2008. the optimal duration of antibiotic therapy has not been studied and experts now recommend for a 7 to 10 days, regardless of the severity of the disease. the evolution of leptospiremia treated patients has not been studied to date.


Eligibility criteria:
inclusion criteria: * adults ( more than 18 years) * diagnosis of leptospirosis confirmed by pcr in the five first day * appeal to one of the hospital departments participating in the research: in emergency room, in complete hospitalization * affiliated patients or beneficiaries of a national insurance scheme * acceptance to participate in the study and in the proposed follow-up, and signature of the consent signed by the person or by his(her) representative exclusion criteria: * test of negative pcr * children under age 18 * no possible follow-up after the first visit * pregnant patient * refusal of participation in the study * unaffiliated patients or beneficiaries of a national insurance scheme.
clinical utility of neuromodulation on tinnitus

Conditions: Tinnitus

Summary: the aim of the present narrative review is to one of the first to critically evaluate the clinical effectiveness of neuromodulation as a therapeutic option for patients with tinnitus. our method involves conducting a systemic review and the findings reported following prisma statement. pubmed, cochrane database and google scholar databases literature search was conducted for articles reporting the use of neuromodulatory interventions on tinnitus patients. each article was evaluated using the cochrane risk of bias tool.


Eligibility criteria:
inclusion criteria: * tinnitus patients * at least one of the neurofeedback methods * single and multi-center * randomized control trials and observational studies exclusion criteria: * non-peer-reviewed papers, letters, editorials * not english language
does double with regular monitoring prevent undesired tooth movement?

Conditions: Malocclusion

Summary: the goal of observational study is to learn about the stability of orthodontic treatment results in orthodontic patients during retention phase of treatment.

the aim of the present study was to three-dimensionally analyze tooth movement in retention phase of treatment and wherever double effectively retention prevents it.

Eligibility criteria:
inclusion criteria: * non-extraction treatment * no hypodontia * normal occlusion after treatment (class i occlusion), perfect alignment * normal overjet and overbite * double retention including fixed retainer bonded from canine to canine in both dental arches and thermally formed removable splint exclusion criteria: * fixed orthodontic treatment in one dental arch * extraction cases * patient treated with orthognathic surgery * imperfect treatment result due to treatment cessation on patients demand or health issues * craniofacial disorders

Keywords: retention stability orthodontic treatment 3d analysis intraoral scan