Kornimate/medical-research-clean huggingface dataset:
evaluate efficacy and safety of saxagliptin in combination with metformin in adult patients with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. this study is designed to evaluate the efficacy and safety in adult patients who have inadequate glycaemic control when treated with metformin in addition to diet and exercise.


Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes * treatment with metformin at a stable dose \>1500 mg/day * hba1c ≥ 7.0% and ≤10.0% exclusion criteria: * insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes) * type 1 diabetes, history of ketoacidosis, or hyperosmolar non-ketonic koma

Keywords: dpp-4 inhibitors hba1c incretins
neonatal resuscitation - sustained inflations

Conditions: Premature Birth

Summary: this study compares a fifteen second sustained inflation (si) to five repeated two - three second 'inflation breaths' during resuscitation at delivery of infants born prematurely.

around 10% of newborns will require some form of assistance after delivery, with babies born more prematurely more likely to require resuscitation current uk guidelines advise initial resuscitation with the delivery of five 'inflation breaths' lasting 2-3 seconds with peak inflation pressure of 30cmh2o (20-25cm h2o in premature neonates). previous studies have shown that despite resuscitation training, clinicians in both simulated and real resuscitation scenarios do not deliver the recommended duration of inflation breaths. this, combined with leaks around the facemask often being as large as 50% or greater, contributes to low expired tidal volumes during resuscitation, thus increasing the likelihood of hypoxia and delay in establishing effective respiration. the use of sustained inflations (up to 15 seconds), rather than intermittent shorter inflation breaths, has shown promising results, with reduction in the need for intubation, and the need for and duration of mechanical ventilation. around 30% of units in germany use sustained inflations as first line delivery room management, as do many other hospitals around the world. resuscitation guidelines from the usa, uk and europe suggest that sustained inflations should be researched further. several studies have shown that for several lengths of inflation breaths, the expired tidal volume achieved is higher if the baby makes respiratory effort during the inflation (active inflation) and that stimulation of spontaneous respiratory effort is a key part in establishing an frc, enabling spontaneous breathing, and increasing the likelihood of successful resuscitation. to date, there are no studies directly comparing whether prolonged inflations are more successful at provoking an inspiration than other methods of resuscitation. we therefore aim to compare a 15 second sustained inflation to repeated shorter inflations to determine which is more effective.

Eligibility criteria:
inclusion criteria: * infants born at less than 34 weeks gestation requiring resuscitation at delivery exclusion criteria: * major congenital abnormalities * parents have previously expressed lack of consent for study
dose escalation of ipi-493 in hematologic malignancies

Conditions: Hematologic Malignancies

Summary: the purpose of this study is to evaluate the safety, determine the maximum tolerated dose (mtd) and schedule of ipi-493 in patients with hematologic malignancies.


Eligibility criteria:
inclusion criteria: * \>/=18 years old * ecog 0-1 * confirmed hematological malignancy * refractory to available therapy or for which no therapy is available * adequate hepatic, renal function exclusion criteria: * active cns malignancy * prolonged qt interval * significant gi/liver disease * other serious concurrent illness or medical condition

Keywords: phase 1 aml cml mpd client proteins hsp90
multicentre canadian study to measure the safety and efficacy of radiosynoviorthesis

Conditions: Arthritis

Summary: radiation synovectomy by intra-articular injection of beta-emitting radionuclides is considered a reliable and easy-to-perform therapy without harmful side-effects for the treatment of inflammatory joint disease in many countries. the goal of this study is to demonstrate yttrium-90 citrate colloid or rhenium-186 sulfide synovectomy are appropriate therapeutic interventions in patients with persistent active synovitis of a joint (characterized by pain, tenderness, and effusion) which is resistant to systemic therapy and intra-articular corticosteroid injections. the primary objective will be to assess the safety of an intra-articular administration of yttrium-90 citrate colloid or rhenium-186 sulfide. the secondary objective will be to assess the efficacy on synovitis.


Eligibility criteria:
inclusion criteria: * there is no age limit for rso * patient referred by a medical joint specialist (orthopedist, rheumatologist or internal medicine in the absence of local joint specialist) * patient having a refractory inflammatory articular disease: * failure of medical therapy after 6 months * clinical signs of an active mono or oligo synovitis * joint x-ray, echo or mr showing minimal cartilage or bone destruction * pain limits normal activities or requires significant analgesic medication exclusion criteria: * prior rso within last 3 months in that joint * collapse of the articular plateau or intra-articular fracture * surgery or arthroscopy within last 6 weeks * painful prosthesis * joint infection, local skin infection, bacteremia * joint puncture within last 2 weeks (increased risk of soft tissue necrosis along the needle track) * pregnancy or breast feeding * synovial cyst rupture * massive hemarthrosis * generalized synovitis defined as more than 5 uncontrolled joints by clinical examination or 3 phases bone scan * surgical synovectomy within 6months * cancer with bone metastases * hypersensitivity, allergies or contraindication to the used radiopharmaceutical agent * participation in any other ongoing clinical trial for the underlying inflammatory condition
china acute myocardial infarction registry

Conditions: Acute Myocardial Infarction

Summary: this study is to build a chinese national registry and surveillance system for acute myocardial infarction(ami) to obtain real-world information about current status of characteristics, risk factors, diagnosis, treatment and outcomes of chinese ami patients; and to propose scientific precaution strategies aimed to prevent effectively from the incidence of ami; and to optimize the management and outcomes of ami patients through implementation of guideline recommendations in clinical practice, and analysis and development of effective treatment strategies; and to create cost-effective assessment system.

the aim of the study is to establish the national platform for surveillance, clinical research and translational medicine in china, designed to facilitate efforts to improve the quality of ami patient care and thus decrease morbidity and mortality associated with ami.

Eligibility criteria:
inclusion criteria: * eligible patients must be admitted within 7 days of acute ischemic symptoms and diagnosed acute st-elevation or non st-elevation myocardial infarction. diagnosis criteria must meet universal definition for ami (2012). all participating hospitals are required to enroll consecutive patients with ami. exclusion criteria: * myocardial infarction related to percutaneous coronary intervention and coronary artery bypass grafting.

Keywords: acute myocardial infarction china registry
the efficacy of mallya in type 2 diabetes transiting from oral antidiabetic drugs to iglarlixi

Conditions: Mallya

Summary: this is a randomized, 12-week, open-label, active-controlled, parallel group study that will collect data of real-time continuous glucose monitoring for seven days at baseline and the end of study from adults with type 2 diabetes mellitus inadequately controlled on oral antidiabetic drugs transiting to their first injectable therapy, iglarlixi. a total of 40 patients will be recruited in taipei veterans general hospital and randomized to use mallya or receive standard care. the study is designed to demonstrate the efficacy of mallya compared to standard care in terms of time in range (glucose level of 70-180 mg/dl), time above range (glucose level ≥180 mg/dl), time below range (glucose level \<70 mg/dl), glycemic variability indices, changes in hba1c and percentage of patients with hba1c ≤7.0% at endpoint, time to stable dose, and diabetes treatment satisfaction. the result of the current study will provide insights into the utility of mallya as a treatment monitoring solution to improve glycemic control.


Eligibility criteria:
inclusion criteria: * age ≥20 years-old * t2dm ≥ 180 days * hba1c ≥ 7.0% at screening * under stable doses of oads for ≥12 weeks prior to screening * insulin naïve (except short term insulin treatment for a maximum of 14 days before screening and/or prior insulin treatment for gestational diabetes) * not currently using real time continuous or flash glucose monitoring * not currently using mallya exclusion criteria: * known or suspected hypersensitivity to randomized treatment or related products * previous participation in this study (participation is defined as signed informed consent); * participation (i.e., signed informed consent) in any interventional, clinical study within 90 days before screening (except for covid-19 study); * female who is pregnant, breast-feeding or intends to become pregnant * presence of severe gastrointestinal disorders, such as severe gastroparesis; * presence of severe renal dysfunction (egfr \<30 ml/min/1.73 m2) or end-stage renal disease on dialysis; * presence of severe hepatic dysfunction (ast or alt level ≥ 200 u/l); * patients with a history of pancreatitis; * patients receiving systemic corticosteroids * patients with active cancer within the past six months.
the outcome of abdominoplasty after massive weight loss

Conditions: Weight Loss

Summary: the primary aim of this study is to compare early surgical complications after abdominoplasty performed by plastic and general surgeons. secondary aims were to assess whether specific guidelines might have impact on the rate of complications. the hypothesis is that general surgeons have more complications.

bariatric surgery has gained widespread acceptance and 6,800 patients are yearly operated in sweden. approximately 30 % of these patients require abdominoplasties for functional disabilities being a total of 2,300 patients. today the plastic surgeons of the departments of plastic and reconstructive surgery do not have the capacity to accommodate this demand. a department of general surgery started to perform abdominoplasties. this is a retrospective cohort study. charts were retrieved from 69 consecutive patients operated by general surgeons at capio s:t görans hospital, stockholm, sweden (group a) from 13th of may to 19th of december 2011. charts from 70 consecutive patients operated by plastic surgeons at the department of plastic and reconstructive surgery, karolinska university hospital, stockholm, sweden (group b) were studied from 14th of january 2010 to 7th of december 2012. collected data consist of patient demographics, operation methods, and complications observed at 30 days' follow-up. the outcome of a third group of about 70 patients operated between 22th of january 2013 to 3th of june 2014 at s:t görans hospital (group c) are compared to the outcome of groups b and a. guidelines for the surgical technique as well as pre-and postoperative care were refined between the operations of group a and c. statistics anova and regression analysis will be applied. and for dichotomous data chi-square test and fischers exact test will be calculated. power was calculated with the test of proportion for two independent groups and 5 per cent significance.

Eligibility criteria:
inclusion criteria: * abdominal skin ptosis \> 3 cm * weight stability \> 6 months * smoke free \> 6 weeks prior to surgery * bmi ≤28 or a significant weight reduction equivalent to 80 per cent of excess weight exclusion criteria: * weight instability * smoking * bmi \>35 * psychological imbalance or psychiatric non-treated diseases * advanced cardio-vascular diseases

Keywords: abdominoplasty early complications guidelines sequelae bariatric patients
integrated multidisciplinary care for parkinson's disease: a controlled trial

Conditions: Parkinson's Disease

Summary: the aim of the present study is to evaluate the (cost) effectiveness of a new health care system in which an individualised multidisciplinary assessment is given to patients with parkinson's disease(pd)in combination with treatment by a dedicated team of specifically trained health professionals, compared to usual care. overall, we anticipate to gain more insight in the clinical effectiveness and health care costs of multidisciplinary treatment in pd.

pd is a complex disorder, with motor as well as non-motor symptoms. despite the complexity of pd, management of the disease is often 'monodisciplinary' since most patients are only treated by a neurologist. stimulating compensatory strategies by allied health professionals might offer additional therapeutic relief, but this assumption is mainly based on theoretical arguments and expert opinion. even less is known about the claim that a multidisciplinary team of multiple professionals active in complementary domains (e.g. physiotherapy, occupational therapy and speech therapy) is superior to management by each of these professionals alone. this study anticipates to provide more insight in the clinical effectiveness and health care costs of multidisciplinary treatment in pd. therefore, our multidisciplinary care concept (a comprehensive assessment by a dedicated multidisciplinary team and subsequent treatment by specifically trained health professionals) that is tailored to the patients' individual needs will be compared to usual care in terms of effectiveness and costs.

Eligibility criteria:
inclusion criteria: * patients with idiopathic pd, diagnosed according to the brain bank criteria of the uk parkinson's disease society * regular control by the neurologist * living independently in the community * able to complete the trial questionnaires exclusion criteria: * atypical parkinsonian syndromes * hoehn and yahr stage 5 * severe cognitive impairment (mmse\<24) * presence of other neurological disorders * severe co-morbidity (e.g. cancer) * planned surgical procedure for pd within the intervention period * patients who have already visited the multidisciplinary assessment center

Keywords: integrated health care system treatment effectiveness cost effectiveness program evaluation
sildenafil to repair brain injury secondary to birth asphyxia

Conditions: Birth Asphyxia

Summary: the investigators will determine the maximum tolerable dose of sildenafil and establish the pharmacokinetic and pharmacodynamic profile of sildenafil in human asphyxiated neonates treated with hypothermia. they will use a 3+3 design to escalate the sildenafil dose up to 6 mg/kg/day (3mg/kg/dose q12h) in asphyxiated neonates demonstrating brain injury despite hypothermia treatment and assess whether we observe any beneficial effects of sildenafil on their brain and cardiopulmonary hemodynamics, without causing serious adverse events


Eligibility criteria:
inclusion criteria: * male and female neonates meeting the criteria for induced hypothermia: * gestational age ≥ 36 weeks and birth weight ≥ 1800 g; * evidence of fetal distress, i.e., history of an acute perinatal event, cord ph ≤ 7.0 or base deficit ≤ - 16 meq/l; * evidence of neonatal distress, such as an apgar score ≤ 5 at 10 minutes, postnatal blood gas ph obtained within the first hour of life ≤ 7.0 or base deficit ≤ - 16 meq/l, or a continued need for ventilation initiated at birth and continued for at least 10 minutes; * evidence of moderate to severe neonatal encephalopathy by an abnormal neurological exam and/or an amplitude-integrated electroencephalogram (aeeg). * evidence of brain injury on a brain magnetic resonance imaging (mri) performed on day 2 of life. exclusion criteria: * neonates with complex congenital heart disease * neonates with cerebral malformations * neonates with genetic syndrome * neonates with intraventricular and/or intraparenchymal hemorrhage on mri performed on day 2 of life
neomycin and metronidazole hydrochloride with or without polyethylene glycol in reducing infection in patients undergoing elective colorectal surgery

Conditions: Colorectal Neoplasms; Diverticulitis; Inflammatory Bowel Diseases; Surgical Site Infection

Summary: this randomized clinical trial studies how well neomycin and metronidazole hydrochloride with or without polyethylene glycol work in reducing infection in patients undergoing elective colorectal surgery. polyethylene glycol, may draw water from the body into the colon, flushing out the contents of the colon. antibiotics, like neomycin and metronidazole hydrochloride, may stop bacteria from growing. it is not yet known whether it's better to give preoperative neomycin and metronidazole hydrochloride with or without polyethylene glycol in reducing surgical site infection after colorectal surgery.

primary objectives: i. to estimate the difference in rates of surgical site infection following elective colorectal resections in patients given a preoperative mechanical bowel prep with oral antibiotics as compared to preoperative oral antibiotics alone. secondary objectives: i. to determine rates of post-operative clostridium difficile infection, adynamic ileus, cardiopulmonary complications, urinary tract infection, length of stay and mortality in patients given preoperative oral antibiotics with a mechanical bowel prep versus preoperative antibiotics alone.

Eligibility criteria:
inclusion criteria: * patients undergoing ileocolic resections, partial and total colectomies, and rectal resections for neoplasm, inflammatory bowel disease, or diverticulitis * subjects with the mental capacity to give informed consent exclusion criteria: * patients undergoing emergent colorectal resections * patients who are decisionally-impaired and lack the mental capacity to give informed consent
safety and efficacy study of umbilical cord-derived mesenchymal stem cells for rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: rheumatoid arthritis is a chronic systemic disease, which is characterized by chronic inflammation in the synovial tissue. rheumatoid arthritis will eventually result in the destruction of cartilage, bone and ligaments and joint deformity. the underlying hypothesis is that umbilical cord-derived mesenchymal stem cell (uc-mscs) has anti-inflammatory effects and thus potentially alleviates the progression of rheumatoid arthritis. the study is to explore the safety and efficacy of uc-mscs transplantation in treatment of rheumatoid arthritis.

this study was supported by the national natural science foundation of china (30872618)，the shanxi province social development public relations project (2012k13-02-35), and the military medicine and public health plan (clz120ga23)

Eligibility criteria:
inclusion criteria: * all patients fulfilled the classification criteria (2010) for rheumatoid arthritis, man or woman aged from 18 to 70 years old. * patients must be informed of the investigational nature of this study and give written informed consent in accordance with the institutional and hospital guidelines. * women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on this trial. women of child-bearing potential must have a pregnancy test performed within 72 hours prior to initiation of treatment. exclusion criteria: * any history of ongoing, significant or recurring infections. * any active inflammatory diseases other than ra. * significant cardiac or pulmonary disease. * end-stage renal failure. * pregnant or nursing women may not participate due to the possibility of fetal harm or harm to nursing infants from this treatment regimen.

Keywords: mesenchymal stem cells rheumatoid arthritis
effect of prolonged military exercises with high load carriage, on neuromuscular fatigue and physiological/biomechanical responses

Conditions: Healthy

Summary: land military missions generally combine prolonged walking/moderate-pace-running and other physical actions such as creeping, jumping, shooting,... which are associated with the direct carrying of high to severe loads of equipment and supplies (20-30 to 50 kg) by soldiers. for an infantry section, "typical" intervention phases last about 20-24 h and combine variable intensity grades. consequently, military mission characteristics are an interesting investigation field of human fatigue. previous studies have investigated human neuromuscular alterations after prolonged "normal" locomotion exercises \[millet et al., 2004, 2009\], thus the aim of this study is to characterize the neuromuscular determinants of fatigue induced by a 24-h simulated military effort (sme) and a 4-h military road march (mm), both performed with high load carriage. additionally, the consequences of fatigue on physiological and biomechanical parameters of locomotion will be investigated.


Eligibility criteria:
inclusion criteria: * to be a male * to have a vo2max \> 45ml/min/kg (mean observed value in military subjects) * to be aged from 30 to 45 * to be recently retreated from national army * to be highly experienced in military efforts * to be trained in exercises involving load carrying * to benefit from a social security insurance exclusion criteria: * all subjects with recent (\< 3 month) bone, articular or muscle diseases. * all subjects presenting a clinic sign of intolerance to testing procedures, especially subjects with knee, ankle, hip or back diseases. * all subjects intolerant to muddy or wooded environment. * all subjects presenting a clinic sign of intolerance to exercise, and particularly to running or walking while carrying a load * all subjects involved at the same time in another medical research * all subjects militarily active * all subjects with cardiac or pulmonary identified and known diseases

Keywords: military exercises neuromuscular fatigue physiological responses biomechanical responses simulated military effort high load carriage healthy voluntary
biomarker-integrated umbrella, advanced gastric cancer

Conditions: Gastric Cancer

Summary: in-depth understanding of molecular characteristics of gastric cancer enabled us to realize personalized medicine with targeted agents in gastric cancer treatment. the investigators initiated open-label, randomized, controlled phase ii, multi-arm trial comparing targeted therapy based on tumor molecular profiling with standard paclitaxel therapy as second line treatment.

in-depth understanding of molecular characteristics of gastric cancer enabled us to realize personalized medicine with targeted agents in gastric cancer treatment.the investigators initiated open-label, randomized, controlled phase ii, multi-arm trial comparing targeted therapy based on tumor molecular profiling with standard paclitaxel therapy as second line treatment.

Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed locally advanced or metastatic gastric cancer and gastroesophageal junction cancer 2. eastern cooperative oncology group performance status of 0 to 1 3. male or female; ≥ 19 years of age 4. on or progression after 1st line palliative chemotherapy 5. subjects with evaluable lesion (using recist 1.1 criteria) 6. subjects who meet the following criteria: * absolute neutrophil count ≥ 1000 /µl * platelet count ≥ 75,000/ µl * serum creatinine \< 1.5 x upper limit of normal or creatinine clearance ≥60 ml/min * aspartate aminotransferase and alanine transaminase 3 x upper limit of normal exclusion criteria: * evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study