Kornimate/medical-research-clean huggingface dataset:
point-of-care echocardiography with assistance technology

Conditions: Cardiac Disease

Summary: establish the effectiveness of the bay labs, inc. echogps software in enabling rns to acquire echocardiograms. in this study an echocardiogram protocol using the echogps interface with the terason usmart 3200t, an fda 510(k)-cleared, commercially available ultrasound device will be performed. participants will have two scans, one by a registered nurse (rn) using the terason usmart 3200t with echogps (study exam) and one by a sonographer using the reference device without echogps guidance (control exam), under the same protocol. study is non-significant risk (nsr).

to validate clinical use of bay labs, inc. echogps guidance software by registered nurses (rns) with no prior scanning experience to acquire limited two-dimensional echocardiograms. in this study an echocardiogram protocol using the echogps interface with the terason usmart 3200t, an fda 510(k)-cleared, commercially available ultrasound device will be performed. participants will have two scans, one by a registered nurse (rn) using the terason usmart 3200t with echogps (study exam) and one by a sonographer using the reference device without echogps guidance (control exam), under the same protocol. study is non-significant risk (nsr).

Eligibility criteria:
inclusion criteria: all patients must meet the following inclusion criteria to participate in the study: * patients scheduled for an echocardiographic examination * patients ≥18 years old exclusion criteria: patients must not meet any of the following exclusion criteria to participate in the trial: * unable to lie flat for study * patients experiencing a known or suspected acute cardiac event * patients with severe chest wall abnormalities * patients who have undergone pneumonectomy * patients unwilling or unable to give written informed consent
influence of sensorimotor treatment in the balance of soccer

Conditions: Ankle Sprain

Summary: this study presents the hypothesis that the sensory processing engine improves balance and agility for football athletes.

objectives: to investigate the influence of the sensorimotor treatment in balance, agility and functionality soccer players assessed using force platform, functional tests and questionnaires. methods: this study was characterized as a randomized clinical trial. 20 male soccer players was assessed by means of questionnaires, force platform in one foot, and functional tests of balance and agility (side hop test, figure of eight hop star excursion balance test and test). to the platform, the parameters of the center pressure (cop) in the anterior- posterior and medial -lateral directions was used for analysis, to functional tests the time-second performance was analyzed. initially all athletes respond to the questionnaires, was evaluated on the force platform and through functional testing by blind evaluators. following, they were randomized to treatment groups (n=10) and control (n=10). the treatment group performed 6 weeks of proprioceptive exercises with shifts and one-leg jumps and bipedal support. the control group remained in soccer training. at the end of the treatment protocol and all were reassessed following the cross-over, where the control group performed the same treatment sensory motor was developed.

Eligibility criteria:
inclusion criteria: * minimum of three years of training in the sport, * participating in state and national competitions, * often training at least five times a week exclusion criteria: * athletes undergoing surgical procedures or have muscle and joint injuries in the lower limbs in the last three months, * which are in physical therapy or who require the use of stabilizers to perform the tests on the platform or during the treatment protocol

Keywords: postural balance athletes sports soccer physiotherapy
cm082 combined with everolimus in chinese patients with metastatic renal cell carcinoma

Conditions: Renal Cell Cancer Metastatic

Summary: this randomized, double blind, phase 2/3 study is aimed to evaluate the efficacy and safety of cm082 in combination with everolimus in chinese patients with advanced renal cell carcinoma. the primary endpoint is progression-free survival.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of clear cell renal cell carcinoma * progressed on at least one standard therapy with vegfr tki * measurable disease per recist v1.1 * eastern cooperative group (ecog) performance status score of 0 or 1 * life expectancy of at least 12 weeks * adequate organ functions, and meet the following requirements: bone marrow: anc ≥1.5\*109/l (1500/mm3), platelet ≥100\*109/l, and hemoglobin ≥9 g/dl liver: total bilirubin ≤1.5 times the upper limit of normal (uln); alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤1.5x the upper limit of normal (uln) if no liver involvement or ≤5x the upper limit of normal with liver involvement kidney: creatinine ≤ 1.25 x uln, urine protein \<1+ heart: lvef ≥ 50% * willingness and ability to comply with trial and follow-up procedures * ability to understand the nature of this trial and give written informed consent exclusion criteria: * currently receiving anti-cancer treatment; currently or previously have received 2 or more systemic anti-cancer treatment * other tumors in addition to renal cell carcinoma * females who are pregnant or breastfeeding * known hypersensitivities to cm082 or everolimus * those with concurrent condition(e.g. psychological, neuronal, cardiovascular, respiratory conditions or infections) that in the investigator's opinion would jeopardize compliance with the protocol * patients with known central nervous system (cns) metastases * presence of active gastrointestinal (gi) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of cm082 or everolimus * any active infection * drug or alcohol abuser
the effect of percutaneous radiofrequency ablation of feeding arterial for hepatocellular carcinoma

Conditions: Liver Neoplasms

Summary: to evaluate a novel technique-ultrasound guided percutaneous abaltion of tumor feeding artery before rfa for liver malignancy.

hepatocellular carcinoma is one of the most common tumor in clinical practice. in recent years, various local therapies, especially radiofrequency ablation (rfa) has been proved safe and effective.the main limitation of rfa is that its therapeutic impact is significant compromised by blood flow cooling effect, especially in hypervascular hcc. recent studies showed combined therapy of tace and rfa can decrease the blood supply of tumor, increase ablated volume and therefore improve the outcome. however, tace application is limited in patients who cannot tolerate this therapy due to the side effects of repeated tace, poor liver function or previously legated hepatic artery. the present study is focus on "difficult-to-treat" hcc patients who are neither surgical candidates, nor tace candidates. the investigators introduce the novel treatment mode that rfa followed ultrasound guided percutaneous ablation of tumur feeding arterial to treat these difficult cases and evaluate the clinical effect.

Eligibility criteria:
inclusion criteria: 1. tumor number ≤3， maximum tumor size ≤5cm; 2. accessibility of tumors via a percutaneous approach; 3. tumor feeding artery can be detected by 3d contrast enhance ultrasound; 4. platelet count ≥ 50,000/ml and inr \<1.6; 5. life expectancy more than 6 months 6. child grade a or b exclusion criteria: 1. patients who scheduled liver transplantation 2. with extrahepatic metastasis 3. women during menstruation, pregnancy, child birth and baby nursing period 4. patients with severe mental disorder 5. cardiopulmonary failure

Keywords: ablation techniques
characterization of enterococci

Conditions: Samples From Patients With Enterococcal Infections

Summary: study on characterization of enterococci because nowadays it become an important cause of nosocomial infections .detection of the most common two species of enterococci and most common virulence factors \& its genes with determination of antibiotics sensitivity test for the isolated strains


Eligibility criteria:
inclusion criteria: * any patients in icu has manifestations of urinary tract infections, surgical wound infections, intra-abdominal infections, intrapelvic infections, bacteraemia and infective endocarditis exclusion criteria: * patients receiving antibiotics in previous 48 hours
intraoperative photodynamic therapy of glioblastoma

Conditions: Glioblastoma

Summary: the study pilot evaluate the feasibility of a "5-ala- ppix (protoporhyrin ix) mediated per-pdt protocol" in patients with glioblastoma accessible for complete surgical removal of contrast. this treatment will be carried out in addition to the current reference treatment of glioblastoma: maximum resection surgery followed by radiochemotherapy according to the protocol stupp


Eligibility criteria:
inclusion criteria: 1. patient male or female ≥18 years 2. general status (who) of performance status 0, 1 or 2 3. probable glioblastoma according to clinical and radiological criteria, 4. whose surgical indication was given in multidisciplinary consultation meeting (rcp) of neurooncology, 5. decision to treat the patient as part of the clinical trial also taken in neuro-oncology rcp ("multidisciplinary consultation meeting") 6. patient operable on the basis of absence of cardiopulmonary disease history; a complete medical check-up sufficient to insure a post-operative state with normal daily life 7. clinical neuro-oncological monitoring and long-term mri scheduled at the hospital chru of lille, center of reference of the region 8. patient able to understand and sign voluntarily informed consent 9. patient able to adhere to the visit's calendar of the study and other imperatives of the protocol 10. women of child-bearing potential should benefit of an effective contraception 11. for patients receiving hepatotoxic therapy in the long term, this treatment must be suspended during the 24h after taking 5-ala 12. patient assigned to an heath insurance exclusion criteria: 1. contraindications to 5-ala (gliolan®) and to per-operative photodynamic therapy "perpdt": 2. contraindications to 5-ala * porphyria * taking photosensitizer treatment * severe renal or hepatic impairment * bilirubin\> 1.5 x maximum level, alkaline phosphatases and transaminases (asat)\> 2.5 x maximum. rates * creatinine clearance \<30 ml / min; * non-compliance with the rules of prevention of the transient risk of cutaneous photosensitization 3. contraindications to surgery 4. contraindications to magnetic resonance imaging (mri) 5. treatment with an experimental drug within 30 days prior to the start of the study 6. clinical follow-up impossible to perform for psychological, familial, social or geographical reasons, 7. legal incapacity (persons deprived of their liberty or guardianship or guardianship), 8. pregnant or nursing women 9. refusal to participate or sign the consent of the study 10. soy allergy

Keywords: glioblastoma
placebo controlled dose-response study of pd-217,014 in the treatment of postherpetic neuralgia

Conditions: Pain

Summary: the purpose of this study is to determine the effectiveness of pd-217,014 in the treatment of chronic pain following a shingles infection.


Eligibility criteria:
inclusion criteria: * patients must have pain present for more than 3 months after the healing of shingles skin rash. * patients at screening must have a score \>=40 mm on the pain visual analogue scale. exclusion criteria: * patients with poor renal function. * patients with other severe pain, that may impair the self-assessment of the pain due to shingles. * patients with abnormal electrocardiogram.
zinc stents for the treatment of gingivitis

Conditions: Gingivitis; Chronic

Summary: background this study investigates the effects of zinc-containing stents on gingival inflammation, bleeding, and plaque regrowth in gingivitis patients. methods a randomized, double-blind, placebo-controlled study was conducted at çukurova university, enrolling 42 systemically healthy gingivitis patients aged 18-30. participants were assigned to either a test group (zinc-containing stents) or a control group (placebo stents) and instructed to wear their stents for at least 12 hours daily for four weeks. clinical measurements, including gingival index (gi), plaque index (pi), and bleeding on probing (bop), were assessed at baseline, and at the 2nd, 4th, and 8th weeks. statistical analysis was performed using ibm spss and rstudio.


Eligibility criteria:
inclusion criteria: * presence of plaque-induced gingivitis \[bleeding on gentle probing at \>30% of sites examined and a gingival index (gi) of at least 1 at \>60% of sites examined\], * plaque index (pi) of ≥ 2 according to the modified quigley\&hein index, * 18-30 years old, * at least 20 natural teeth, * systemically healthy. exclusion criteria: * pocket probing depth (ppd) of ≥4 mm, * interdental clinical attachment loss (cal) detectable at ≥2 nonadjacent teeth or displaying buccal/oral cal ≥3 mm coupled with pd ≥3 mm * subjects with a history of allergies to zinc, * the presence of hematologic disorders or any other systemic illness, * pregnancy and breastfeeding, * current orthodontic treatment, * history of periodontal therapy, * use of antibiotics or anti-inflammatory medication within the preceding 6 months, * smoking.

Keywords: gingivitis zinc treatment
to assess the effect of lorcaserin hydrochloride on energy metabolism and food intake

Conditions: Obesity

Summary: the purpose of this study is to evaluate the effect of lorcaserin on energy metabolism and food intake in obese and overweight patients.


Eligibility criteria:
inclusion criteria: 1. males or females aged between 18 and 65 years (inclusive) 2. body mass index (bmi) is 27.0 to 45.0 kg/m2, inclusive 3. able to give signed informed consent 4. ambulatory and able to perform exercise program (arena healthy lifestyle program, see appendix 1) 5. eligible male and female patients must agree not to participate in a conception process 6. considered to be in stable health in the opinion of the investigator exclusion criteria: 1. prior participation in any study of lorcaserin. 2. participants who are current smokers or have smoked within the previous 6 months. no smoking will be allowed during the study. 3. clinically significant new illness in the 1 month before screening 4. not suitable to participate in the study in the opinion of the investigator including an existing physical or mental condition that prevents compliance with the protocol 5. recent history (within 6 months before entering the study) of major depression, anxiety, or other psychiatric disease requiring treatment with prescription medication. ssri's, snri's, and other medications must meet washout requirements. 6. significant dislike or allergy to foods used during the food intake tests 7. history of any of the following cardiovascular conditions: * myocardial infarction (diagnosed by cardiac enzyme\[s\] and/or diagnostic ecg), cva, tia or rind within 3 months of screening; cardiac arrhythmia requiring medical or surgical treatment within 3 months of screening * unstable angina * history of congestive heart failure caused by insufficiency, damage, or stenosis of any heart valve * history of pulmonary artery hypertension 8. positive result of hiv, hepatitis b or hepatitis c screens 9. recent treatment (i.e., within 1 month of the screening visit) with over-the-counter weight loss products or appetite suppressants (including herbal weight loss agents), or within 3 months with a prescription anti-obesity drug (e.g., phentermine, sibutramine, orlistat) 10. participated in any clinical study with an investigational drug, biologic, or device within 1 month prior to screening
post market registry study of intracranial aneurysms treated with sugita clipping devices

Conditions: Brain Aneurysm

Summary: the objective of this study is to verify the performance and safety of the sugita aneurysm clips devices when used as intended and to identify possible risk factors. data collected will be used to support the continuing performance and safety of the devices in the post-market use environment in europe. subjects who have an intracranial aneurysm that the physician intends to treat with the subject devices will be included in the study. subjects will be followup as per hospital standard of care for 5 years.


Eligibility criteria:
inclusion criteria: * subject has an intracranial aneurysm (ruptured or unruptured) that can be treated with one of the proposed devices. * subject is adult, ≥18 years. * as per national regulations, subject or subject's legally authorized representative (lar) has signed written informed consent. * subject is willing to comply with scheduled visits and examinations per institutional standard of care. exclusion criteria: * subject is currently enrolled in or plans to be enrolled in a concurrent drug or device randomized study. * subject has a condition which will not allow him/her to comply with his/her post-procedure follow up per the institutional standard of care (medical condition, subject living abroad and unable to return for follow- up, e.g.). * subject does not meet ifu criteria of the subject device. * subject is a child, \<18 years.

Keywords: clip sugita
a multi-center, prospective, observational study to describe the situation of blood lipid management among the population with hypertension and/or type 2 diabetes in community health center

Conditions: Lipoprotein Disorder

Summary: a multi-center, prospective, observational study to describe the situation of blood lipid management among the population with hypertension and/or type 2 diabetes in community health center


Eligibility criteria:
inclusion criteria: 1. the informed consent form (icf) should be signed before conducting any research-related operations 2. age ≥18 years 3. patients with well-diagnosed hypertension (htn) and/or type 2 diabetes (t2dm) and have been ill for ≥ 3 months 4. the patient underwent fasting lipid analysis in the past 1 month and the data was fully recorded exclusion criteria: 1.patients with well-diagnosed atherosclerotic cardiovascular disease (ascvd) 2. have received any form of lipid-lowering treatment within 4 weeks before the screening period 3. the patient is currently participating in any other clinical trial except this study -
ultrasound to enhance paclitaxel uptake in critical limb ischemia: the pacus trial

Conditions: Peripheral Arterial Disease, Angioplasty

Summary: the pacus trial was a single center, single blinded, randomized trial designed to evaluate the safety and efficacy of intravascular percutaneous catheter-delivered ultrasound energy to improve local paclitaxel delivery effects in critical limb ischemia patients due to femoral-popliteal artery disease.

study design the pacus trial was a single center, single blinded, randomized trial designed to evaluate the safety and efficacy of intravascular percutaneous catheter-delivered high intensity, low-frequency ultrasound utilizing cardioprolific genesis™ system to improve local paclitaxel delivery effect in patients with cli due to femoral-popliteal calcific lesions and occlusions. the protocol was approved by a local review boards and the institutional ethics committee. all patients provided written informed consent before enrollment. the trial was conducted in accordance with the declaration of helsinki. randomization randomization occurred after successful crossing and pre-dilatation of the target lesion with a standard percutaneous angioplasty balloon without sub-intimal approach and/or flow limiting dissections. patients were enrolled when a successful angiographic control was performed after pta pre-dilatation. subjects were randomly assigned by a computer-generated random sequence (2 blocks in a 1:1 ratio). randomization was done in advance for all patients and without any stratification. the patients and physicians involved in the follow-up control were blinded to the treatment assignments through the completion of all 6 month follow-up evaluation. operators were not blinded due to differences in treatment protocol. twenty eight (28) patients were treated with an intravascular percutaneous catheter-delivered high intensity, low-frequency ultrasound and local paclitaxel delivery with temporarily blood flow occlusion created by distal occlusion balloon (study group), and twenty eight (28) patients were treated with drug eluting balloon with conventional method (control group).

Eligibility criteria:
inclusion criteria: * rutherford category ≥4 * femoral-popliteal lesion ≥10cm * successful intraluminal recanalization without need of a stent to obtain a satisfactory angiographic result * at least one patent below the knee vessel * patients older than 18 years exclusion criteria: * rutherford category \< 4 * pregnancy * known allergies to study medications and materials * need of sub-intimal approach to perform the recanalization * target vessel stent release
metformin pharmacokinetics in patients with chronic and acute heart failure

Conditions: Heart Failure, Systolic

Summary: the study evaluates the pharmacokinetics of metformin in heart failure patients in acute and chronic state in relation to metformin transporter genotypes. participants have heart failure and type 2 diabetes treated with metformin. hypothesis: primary: the renal clearance of metformin is decreased in acute state of congestive heart failure compared with chronic state. secondary: metformin trough values in hf patients are influenced by polymorphisms in transporter genes relevant to the pharmacokinetics of metformin.

background: heart failure (hf) is a common disease and diabetes/insulin resistance are present in approximately 50 % of hf patients. metformin is the most commonly prescribed oral anti-diabetic drug, and a huge inter-individual variability in trough steady-state metformin concentration in type 2 diabetics have been demonstrated. genetic polymorphisms in metformin transporter genes are likely to have a direct impact on metformin pharmacokinetics and variability in drug responses, but the influence of polymorphisms in these transporter genes on circulating metformin levels is presently unknown in hf patients. objectives: a) to compare the pharmacokinetics of metformin in 12 diabetic patients with hf in acute and chronic state. b) to investigate the influence of polymorphisms in genes encoding the metformin transporter proteins on metformin trough levels in 150 diabetic hf patients. design: an open, single-center study enrolling 12 patients with acute heart failure (study a) and 150 patients with stable chronic heart failure (study b). the participants have diabetes already treated with metformin prior to inclusion. through repeated blood draws, the concentration of metformin will be determined along with genotyping for metformin transporter genes. primary outcome: study a: changes in renal clearance of metformin between patients with acute and chronic heart failure. study b: mean trough steady-state concentrations of metformin with emphasis on the intra-interindividual variability in hf patients.

Eligibility criteria:
inclusion criteria: * patients with heart failure * lvef \< 45% within 12 months prior to inclusion * nyha-class i, ii, iii or iv * ability to understand the written patient information and to give informed consent * diabetes type 2 (and in metformin treatment for \> 1 month) * stable dosage of metformin treatment for at least 1 week prior to examination exclusion criteria: * age \< 18 years * current abuse of alcohol or drugs