Kornimate/medical-research-clean huggingface dataset:
phase iv clinical trial of ceftriaxone sodium and sulbactam sodium for injection (cro-sbt)

Conditions: Respiratory Tract Infections; Urinary Tract Infections in Children

Summary: to evaluate the safety and efficacy of treatment of children with acute bacterial infection disease with ceftriaxone sodium and sulbactam sodium for injection in the condition of widely used, and provide the basis of adjusting the dosage regimen for children in particular.

ceftriaxone sodium and sulbactam sodium for injection (2:1)plays a therapeutic role by the former inhibiting bacterial cell wall synthesis，the latter making irreversible competitive inhibition of β-lactamase.the antimicrobial effect of ceftriaxone can be enhanced by the two combined. the compound specifically aims to the mechanism of bacterial resistance, extending the life of ceftriaxone in the treatment-resistant pathogen infections.

Eligibility criteria:
inclusion criteria: * male or female children ages≥6 years to\< 14 years. * weight≥18kg who in hospital or outpatients with good compliance; * the subjects were diagnosed as respiratory infection, urinary tract infection or other infection caused by the compound sensitive bacteria after clinical symptoms and signs laboratory examination and auxiliary examination according to the clinically recognized diagnostic criteria, and should be treated with systemic antibiotics; * subjects had not used effective antimicrobial agents before screening, or had used antimicrobial agents but the efficacy was not obvious; * no severe liver and kidney cardiovascular and hematopoietic diseases were found in the subjects (ast and alt were not more than 1.5 times of the upper limit of normal value,cr was within the normal range); * subject guardian informed consent and/or subject's own informed consent subject volunteers to participate in this study and has signed the subject's informed consent. exclusion criteria: * history of hypersensitivity reactions to carbapenems, cephalosporins, penicillin, other β-lactam antibiotics; * patients with specific infections who require treatment with other antimicrobial agents; * use of penicillin roxithromycin vitamin b vitamin c and other drugs may interfere with the efficacy or safety evaluation of drugs at the same time; * patients at risk of serious drug interactions due to combination of medications; * patients who have other diseases and thought to affect efficacy evaluations or be poor compliance; * attended clinical trial in three monthes.
sensory-play based (senplay) intervention for young children with or at risk for adhd

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the purpose of this pilot study is to determine the effects of 15 minutes of sensory-play based (senplay) intervention on improving focused attention in developmentally appropriate tasks in young children with or at risk for adhd.

after being informed about the study and potential risks, written consent will be obtained by the investigators. twenty participants will be recruited for this randomized, experimental study with a two-group longitudinal, pre-posttest, linear association study design to measure attention levels and off-task behaviors. all participants will attend a total of four sessions. the investigator, a registered, licensed occupational therapist, will lead all intervention sessions utilizing a set protocol. participants will complete an intake session to determine baseline fine motor skills for developmentally appropriate tasks (dat) before being randomly assigned to either the control group or the senplay intervention group. the control group will engage in spontaneous, free play with the supervising only for safety within the sensorimotor gym (see image 1) for 15 minutes, prior to the assessment of off-task behaviors during 10 minutes of dat. the intervention group will engage in 15-minutes of senplay intervention, followed by assessment of off-task behaviors during 10 minutes of dat. the 10 minutes of dat will be coded at the beginning of each 15 second interval (wood et al., 2016) for a total of 40 observation periods. the percentage of on and off-task behaviors will be calculated. two coders, blinded to the group assignment will code session. prior to the study, both coders will achieve a reliability of at least 95% accuracy in training sessions.

Eligibility criteria:
inclusion criteria * age 3-years, to 5-years, 11-months * diagnosis or provisional diagnosis of adhd or overactivity by the primary care physician, psychologist or neurologist * no diagnosis of neurological disorders other than adhd * normal or corrected vision * cognitive skills to follow verbal instruction * gross and fine motor skills to engage in sensorimotor activities and school readiness tasks exclusion criteria: * participants will be excluded if they currently take medication for adhd or exhibit severe physical impairments that result in inability to engage in the senplay intervention, fine motor and visual motor activities.

Keywords: attention focused attention sensory play-based intervention occupational therapy pediatrics
measurement of gemcitabine metabolites in blood and urine as predictors of response to gemx bladder radiotherapy

Conditions: Bladder Cancer

Summary: the purpose of this study is to test the hypothesis that plasma, peripheral blood mononuclear cell and urine levels of gemcitabine and its metabolites, 30 mins or 2 hours post infusion, predict response to gemx chemoradiation at first check cystoscopy, 3 months from the end of radiotherapy.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of muscle-invasive transitional cell carcinoma. * suitable for treatment with radical concurrent chemoradiotherapy with gemx. * standard radiological assessments with ct or mr for staging. * ecog performance status 0-2 * adequate pre-treatment haematological and biochemical parameters * age greater than or equal to 18 years * no significant co-morbidity thereby excluding patient from having radical treatment. * no previous treatment for diagnosis of muscle-invasive bladder cancer or other pelvic radiotherapy. * women of child bearing age must have a negative pregnancy test prior to study entry and be using an adequate contraception method, which must be continued for 3 months after the study, unless child bearing potential has been terminated by surgery/radical radiotherapy * patients must have given written informed consent exclusion criteria: * patients with a known history of anaphylactic reaction to any other drug. * patients must not have a history of other malignant diseases other than adequately treated non-melanotic skin cancer or in-situ carcinoma of the uterine cervix * any evidence of severe or uncontrolled systemic diseases which, in the view of the investigator, makes it undesirable for the patient to participate in the trial. * evidence of significant clinical disorder or laboratory finding which, in the opinion of the investigator makes it undesirable for the patient to participate in the trial any other serious uncontrolled medical conditions * clinical evidence of metastatic disease to brain * any pregnant or lactating woman * any patient with a medical or psychiatric condition that impairs their ability to give informed consent

Keywords: radiotherapy gemx chemoradiotherapy bladder cancer
the analgesic efficacy of the pectoral nerves block versus local anesthetic infiltration after mastectomy

Conditions: Breast Cancer

Summary: this trial will include patients undergoing radical mastectomy under general anesthesia. one group of patients will receive a pectoral nerve block, done by the anesthetist under ultrasound guidance at the beginning of the invervention. the other group will receive the a wound infiltration at the end of the intervention, done by the surgeon. investigators will compare acute pain-related outcomes and chronic pain at 3 and 6 months postoperatively.

mastectomies are associated with moderate to severe postoperative pain. in addition to general anesthesia, different methods of locoregional anesthesia exist to treat postoperative pain, amongst others a pectoral nerve block. this block consists in injecting local anesthetic between the muscles of the thoracic wall and is done under ultrasound guidance. over the last few years, the pectoral nerves block has become a recognized option for the treatment of acute post-mastectomy pain and it is routinely performed in addition to general anesthesia. data indicates that pectoral nerve blocks are effective for the treatment of postoperative pain during the first 24 hours after mastectomy, when compared to no block. however, the analgesic efficacy of a pectoral nerve block has never systematically compared to that of wound infiltration with local anesthetics, done by the surgeon at the end of the intervention. such an infiltration is also currently employed. in our study randomize patients undergoing mastectomy under general anesthesia will be randomized to receive either an ultrasound-guided pectoral nerve block with 30 ml of local anesthetic (group pecs) or a wound infiltration with 30 ml of local anesthetic (group infiltration). investigators will assess different pain-related outcomes over the first 24 postoperative hours, together with potential block-related side effects and patient satisfaction. chronic postoperative pain at 3 and 6 months postoperatively will also be assessed. both patients and outcome assessors will be blinded to group allocation.

Eligibility criteria:
inclusion criteria: * patients undergoing unilateral mastectomy * american society of anesthesiology physical status i-iii * age ≥ 18 exclusion criteria: * contraindications to regional anesthesia, such as infection at the surgical site * pregnancy * history of alcohol or drug dependence/abuse * history of long term opioid intake * chronic pain disorder

Keywords: mastectomy
effect of abdominal massage on constipation after cardiac surgery

Conditions: Abdominal Massage

Summary: background and aim: although the incidence of gastrointestinal complications after cardiovascular surgery is reported to be rare, it has been reported that patients experience problems with constipation within the week after discharge. the presence of abdominal distension due to constipation after cardiac surgery may lead to prolonged wound healing, paralytic ileus and gastric dilatation. this study aimed to evaluate the effect of abdominal massage on constipation after cardiac surgery. methods: a prospective, randomised controlled quasi-experimental study was conducted in the cardiovascular surgery clinic of a public hospital between september 2022 and july 2023. a power analysis was performed to determine the sample size. a total of 130 patients were randomly assigned to the experimental or control group using a simple randomisation method. data were collected using a 21-item form from the first day after surgery. burping and defecation times of the patients were evaluated and recorded. results: the mean age of the experimental group was 55.2±13.3 years, while the mean age of the control group was 60.4±10.6 years (p=0.015). there was no statistically significant difference between the groups in terms of sociodemographic characteristics, bowel preparation and preoperative fasting times. it was observed that bowel sounds started earlier in the experimental group (70.8% on the first postoperative day) compared to the control group (46.2% on the first postoperative day) (x2=16.629; p=0.005). the first burping time measurements in the control group (x̄=46.415 hours) were higher than those in the experimental group (x̄=31.262 hours). postoperative defecation time was longer in the control group (x̄=99.51 hours) than in the experimental group (x̄=61.611 hours).


Eligibility criteria:
inclusion criteria: * - being older than 18 years * agreeing to participate in the study * undergoing a cardiac surgery * not having a barrier for communication * not having a mental or cognitive disability * not using constipation treatment (like laxatives or enemas) * having no history of constipation disorders or gastrointestinal surgery. exclusion criteria: -

Keywords: cardiac surgery abdominal massage constipation
title: an open, non-comparative, multi-centre post marketing clinical follow-up (pmcf) investigation to evaluate performance and safety on diabetic foot ulcer, dfu, when using mepilex transfer ag as intended

Conditions: Diabetic Foot Ulcers

Summary: an open, non-comparative, multi-centre post marketing clinical follow-up, pmcf, investigation to evaluate performance and safety on diabetic foot ulcer, dfu, when using mepilex transfer ag as intended.

approximately 25-30 subjects from two to three centers will be evaluated provided they fulfill the inclusion criteria and none of the exclusion criteria and gives a signed and dated consent. subjects to be included were to suffer from a dfu and being in need of anti-microbial wound dressing. dressing changes were to performed according to the local clinical routine (usually 3 times/week), evaluated during a total treatment period of maximum 4 weeks including weekly visits when assessments were being done. a record (dressing log) for mepilex transfer ag and outer layers were to be filled in at every dressing change. photos taken directly upon dressing removal and after cleansing /debridement were to be collected to visually follow the ulcers status. at each visit the investigators/nurse and subjects opinion (using an evaluation form) were to be asked for questions considering the use of mepilex transfer ag. pain before, during and after removal will be assessed.

Eligibility criteria:
inclusion criteria: 1. both gender\>=18 years old 2. subjects with type 1 or 2 diabetes mellitus 3. two of the signs of infection must be present and recorded (redness, heat, oedema, pain, increased exudates amount, deteriorating wound, fever, odour) 4. ulcer localization; below the ankle 5. signed informed consent exclusion criteria: 1. dry wound 2. known allergy/hypersensitivity to the dressing 3. treated with other silver dressing on the ulcer target within 1 week prior to this investigation 4. subjects who will have problems following the clinical investigation plan 5. subjects enrolled in the investigation already 6. subjects included in other ongoing clinical investigation at present or during the past 30 days. subjects participating in a clinical sample investigation might be enrolled in the investigation.
investigation of multiple ultrasound techniques for the assessment of carotid plaque vulnerability

Conditions: Arteriosclerosis

Summary: stroke is a common clinical disease with high disability and mortality, which seriously threatens human life and health.carotid atherosclerotic plaque rupture is an important pathogenic basis of ischemic stroke, so judging the stability of plaque has important clinical significance in preventing ischemic stroke.ultrasound, as a convenient, rapid, noninvasive, radiation-free auxiliary examination technology, is widely used in carotid plaque stability examination.at present, there are many methods to judge the stability of carotid plaque based on ultrasound, including two-dimensional ultrasound, contrast-enhanced ultrasound, ultrasound elastography and so on. however, the results of plaque stability judgment by various technologies deviate greatly, which is not conducive to the development of standardized diagnosis and treatment strategies by clinicians.studies have shown that because the neovascular epidermal cells in atherosclerotic plaques are imperfect, they are easy to rupture after stress, and the ruptured neovasculature will lead to intraplaque hemorrhage, thus causing plaque shedding, and eventually obstructing the cerebrovascular cause stroke.contrast-enhanced ultrasound can sensitively detect the distribution and course of blood vessels.the plaque's softness and hardness determine its stability, while the difference of lipids, fibers and calcium in the plaque determines its softness and hardness.real-time ultrasound elastography can provide tissue mechanical parameters, express the soft and hard of tissue with strain value, and provide important reference information for judging plaque stability.at present, elastography technology is used to reflect the hardness of plaque, so as to further judge its stability.however, the elastography parameters are prone to deviations due to the influence of the selected section and the selected region of interest.it can be seen from the above that there is currently a multi-modality method to evaluate the stability of carotid plaque using ultrasound, but there is a lack of a unified and objective reference standard for plaque stability assessment.the purpose of this study is to explore the comprehensive utilization of these modalities under the premise of optimizing each ultrasound modality to provide a unified and objective criterion for judging the stability of carotid plaque.


Eligibility criteria:
inclusion criteria: * at least one examination suggested the presence of carotid plaque * suitable for ceus examination * voluntary enrollment in this study and signing of informed consent exclusion criteria: * among ischemic brain rates caused by non-carotid plaque shedding * follow-up lost * pregnant women

Keywords: ultrasound
exercise and blood pressure in children: a meta-analysis

Conditions: Cardiovascular Diseases; Heart Diseases; Hypertension

Summary: to use the meta-analytic approach to examine the effects of aerobic exercise on resting systolic and diastolic blood pressure in children.

background: approximately 50 million americans suffer from hypertension, a condition associated with increased risk for stroke, heart attack, and kidney failure. while non-pharmacological intervention has resulted in dramatic reductions in resting systolic and diastolic blood pressure for those with elevated pressures, a debate continues over the efficacy of pharmacological intervention because of deleterious side effects. as a result, there has been an increased interest in aerobic exercise as a non-pharmacologic approach in treating hypertension. recent reviews of literature have synthesized research using the 'traditional' approach (chronologically arranging and describing the studies, perhaps by sub-topic) which may result in subjective, non-replicable conclusions. consequently, the relationships among such variables as subject characteristics, experimental design quality, training program characteristics, and how they contribute to changes in resting systolic and diastolic blood pressure is not clear. the meta-analytic approach is used in the study to synthesize research on the relationships among variables associated with aerobic exercise intervention and resting systolic and diastolic blood pressure in adults. meta-analysis is a method of pooling the results of separate studies. it is a quantitative approach for increasing statistical power of primary end points and subgroups, resolving uncertainty when studies disagree, improving estimates of effect sizes, and answering questions not posed at the start of individual trials. design narrative: in the first two years of the study, a meta-analysis was conducted of all studies published since 1966 on aerobic exercise and blood pressure. the study was renewed in fy 2000 to conduct meta-analysis of all studies of exercise training in children and youth under age 21 years in which resting bp was measured. this will include both randomized and non-randomized clinical trials of at least eight weeks duration found in english journals and theses between 1966 and 1999. standard meta-analysis techniques will be applied. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
safety and performance aspects of crt-dx system in patients with sinus rhythm

Conditions: Heart Failure; Cardiac Resynchronization Therapy

Summary: the conventional crt-d system consists of 3 leads in patients with heart failure (hf). a part of hf patients have non-impaired sinus node function and will not be stimulated in the right atrium. the implantation of the right atrial lead, which is not mandatory in these patients, harbors potential complication risks and prolongs implantation procedure. the new crt-dx system uses 2 leads only: a right ventricular lead extended with floating ra sending dipole and a left ventricular lead. the aim of the bio\|reduce study is to assess the residual safety and performance aspects of the crt-dx system within 12 months follow-up in hf patients with an indication for a crt-d, sinus rhythm, and no need for an atrial lead implantation.


Eligibility criteria:
inclusion criteria: * patient is able to understand the nature of study and has provided written informed consent. * patient is willing and able to perform all follow up visits at the study site. * patient is willing and able to use the cardiomessenger® and accepts the biotronik home monitoring® concept. * crt-d is indicated according to the current esc guidelines. * de novo implantation with no pre-existing defibrillator or pacemaker system * patient is in sinus rhythm without history of persistent or permanent atrial fibrillation. * patient has no atrioventricular (av) block ii or iii. * patient has no evidence of impaired sinus node function. * patient has no need for atrial stimulation, has a resting heart rate (hr) \> 40 b.p.m and achieves a peak hr ≥100 b.p.m even under intended dosage of hr lowering medication verified by an appropriate method as clinical routine examination within 3 months prior to enrollment * nyha class ii or iii * patient receives guideline-based optimized medical therapy for hf including heart-rate lowering medication at the time of enrollment exclusion criteria: * patient is pregnant or breast feeding. * patient is less than 18 years old. * patient is participating in an interventional clinical investigation. * life-expectancy is less than 1 year. * patient has tachycardia-bradycardia syndrome * any standard contraindication for crt-d * frequent premature ventricular contractions (pvc rate \> 5 %/h) examined within 3 months prior to enrollment by appropriate routine method (e.g. 24 h holter electrocardiogram)

Keywords: heart diseases crt-d
a pilot feasibility study of mindfulness-oriented recovery enhancement with pregnant women with opioid use disorder

Conditions: Opioid-use Disorder

Summary: thirty pregnant women with substance use disorder will be recruited to participate in eight sessions of more.

participants will be asked to complete a battery of self-report measures and a semi-structured qualitative interview at three times points-before the intervention begins, after session four, and again after session eight. participants will also be asked to complete self-report measures before and after each session. the primary aims of this study are as follows. aim 1: to adapt the in-person more intervention for telehealth delivery. aim 2: to assess the overall feasibility and acceptability of this telehealth intervention. hypothesis: more delivered via telehealth will be both feasible and acceptable to participants.

Eligibility criteria:
inclusion criteria: * must be pregnant. * must be able to communicate in english. * must have met criteria for opioid use disorder in the past year. exclusion criteria: * none.