Kornimate/medical-research-clean huggingface dataset:
efficacy of lidocaine block in children with cerebral palsy and dysphagia

Conditions: Cerebral Palsy

Summary: the goal of this clinical trial is to test the efficacy of stellate ganglion block in children with cerebral palsy and dysphagia. the main question it aims to answer are: • can stellate ganglion block improve the dysphagia of children with cerebral palsy? participants were randomly divided into two groups, all provided with routine therapy. based on this, the experimental group was given stellate ganglion block. the video fluoroscopic swallowing study was done to test the swallowing function before and after the study.

cerebral palsy is a common non-progressive clinical condition characterized by motor disorders and abnormal postures, which significantly impact the quality of life of affected children. swallowing dysfunction is a common complication in children with cerebral palsy , affecting their daily eating and communication skills, and hindering their nutritional development and social interaction. stellate ganglion block has shown certain efficacy in improving swallowing function in children with cerebral palsy. however, there is limited research on the effects of stellate ganglion block treatment on swallowing dysfunction in children with cerebral palsy. therefore, this study aims to explore this topic and provide scientific evidence for its clinical application. the goal of this clinical trial is to test the efficacy of stellate ganglion block in children with cerebral palsy and dysphagia. the main question it aims to answer are: • can stellate ganglion block improve the dysphagia of children with cerebral palsy? participants were randomly divided into two groups, all provided with routine therapy. based on this, the experimental group was given stellate ganglion block. the video fluoroscopic swallowing study was done to test the swallowing function before and after the study.

Eligibility criteria:
inclusion criteria: * meeting the diagnostic criteria of cerebral palsy formulated by the 13th national conference on pediatric cerebral palsy rehabilitation; * age between 4 to 7 years; * diagnosed as dysphagia confirmed by dysphagia disorder survey or pediatric esophagoscopy; exclusion criteria: * with dysphagia caused by other diseases or factors; * progressive neurological disease or degenerative neurological disease; * with severe heart disease, liver or kidney dysfunction, hematological disorders; * with abnormalities in the oral cavity, pharynx, esophagus, or other parts of the digestive tract; * with poor compliance.
efficacy and safety of the insulin glargine/lixisenatide fixed ratio combination (lixilan) to lixisenatide on top of oral anti-diabetic drugs (oads) with type 2 diabetes in japan

Conditions: Type 2 Diabetes Mellitus

Summary: primary objective: to compare lixilan to lixisenatide in glycated hemoglobin (hba1c) change from baseline to week 26 in patients with type 2 diabetes mellitus. secondary objective: to compare the overall efficacy and safety of lixilan to lixisenatide (with or without oads) over a 52 week treatment period in patients with type 2 diabetes mellitus.

approximately 55 weeks: an up-to 2-week screening period, a 26-week randomized open-label treatment period, a 26-week safety extension treatment period and a 3-day post-treatment safety follow up period.

Eligibility criteria:
inclusion criteria : * patient with type 2 diabetes mellitus (t2dm) diagnosed for at least 1 year before the screening visit, receiving 1 or 2 oads that can be biguanide, thiazolidinedione, alpha-glucosidase-inhibitor, sodium glucose co-transporter 2 inhibitor; sulfonylurea, rapid-acting insulin secretagogue, or dipeptidyl-peptidase-4 inhibitor. * signed written informed consent. exclusion criteria: * at the screening visit: age \<20 years. * at the screening visit: hba1c \ 10%. * at the screening visit: fasting plasma glucose (fpg) \>250 mg/dl (13.8 mmol/l). * pregnancy or lactation, women of childbearing potential with no effective contraceptive method. * use of oral or injectable glucose-lowering agents other than those stated in the inclusion criteria during the 3 months before the screening visit. * previous treatment with insulin (except for short-term treatment due to intercurrent illness including gestational diabetes at the discretion of the trial physician). * laboratory findings at the screening visit, including: * amylase and/or lipase \>3 times the upper limit of the normal laboratory range (uln), * alanine aminotransferase (alt) or aspartate aminotransferase (ast) \>3 uln, * calcitonin ≥20 pg/ml (5.9 pmol/l), * positive serum pregnancy test. * contraindication to use of lixisenatide according to the local labeling. history of hypersensitivity to any glucagon-like peptide-1 receptor agonist (glp-1ra) or to metacresol. * contraindication to use of insulin glargine according to the local labeling. history of hypersensitivity to insulin glargine or to any of the excipients. * patient who has a severe renal function impairment with estimated glomerular filtration rate (egfr) \<30 ml/min/1.73m\^2 or end-stage renal disease for patient not treated with metformin. * personal or immediate family history of medullary thyroid cancer (mtc) or genetic condition that predisposes to mtc (eg, multiple endocrine neoplasia syndromes). * history of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy has been performed), pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, pancreatectomy, stomach/gastric surgery. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
interactive parent-targeted text messaging in pediatric clinics to reduce caries among urban children

Conditions: Caries, Dental; Health Behavior

Summary: this is a randomized clinical trial to test the efficacy of a parent-targeted text message-based intervention program on caries incidence and oral health behaviors (child and parent). parents (n= 850) across all pediatric clinic sites (boston medical center and community health centers (chcs); dothouse chc, south end community health center, and codman square chc) will be randomized to receive either text messages (tms) regarding oral health or tms regarding child wellness. the study will enroll english and spanish speaking parents and their youngest child who is \< 7 years old, has at least one tooth showing, and attends the targeted pediatric clinic to receive primary care (n= 1700). parents will complete self-report surveys at baseline, and 2, 4, 12, and 24-months after baseline; receive and respond to tm assessments during the 4-month intervention; and will also receive tms during a 'booster' period of one month, which will occur 12-months post baseline. parent's children will be assessed for caries by a clinical oral examination performed by licensed clinical examiners at baseline, 12-and-24-months post-baseline.


Eligibility criteria:
inclusion criteria: caregiver and child must meet all of the following: 1. caregiver must be a parent or legal guardian of a child less than 7 years old, and the child must have their first tooth showing 2. the child must receive medical care at one of the participating pediatric clinics. 3. speak, understand, and read either english or spanish 4. have a mobile phone. exclusion criteria: if the caregiver or child meets any of the following criteria, the dyad will be excluded from participation in this study 1. children with severe congenital tooth malformations: at screening the caregiver will be asked if their child has known systemic diseases associated with abnormal tooth development or abnormal oral health status such as cleft lip or palate, amelogenesis imperfecta, or dentinogenesis imperfecta. 2. children who cannot complete the baseline oral health exam.

Keywords: child oral health behaviors text messages motivation self efficacy outcome expectations sugar sweetened beverage consumption fluoride varnish healthy eating parent oral health behaviors parent oral health attitudes fluoride early childhood caries
dexmedetomidine as an additive to local anaesthesia to decrease intraocular pressure in glaucoma surgery

Conditions: Glaucoma

Summary: nowadays, a number of cases with increased intraocular pressure and glaucoma have been shown a huge increase . this is because of the increase the geriatric population in the community and advanced medical care. surgical correction, as a treatment, solves this problem greatly especially with the modern surgical techniques . peribulbar block reduced the admission discharge time and reduced the burden on both the patients and the medical team. on the other hand, it carries the risk of increased intraocular pressure (iop). which, subsequently, limit its usage in glaucoma surgery. dexmedetomidine, as an alpha 2 agonist, has a well-established role in decreasing intraocular pressure (iop). this effect has been shown at a histological level and clinical level

nowadays, number of cases with increased intraocular pressure and glaucoma has been shown a huge increase . this is because of the increase the geriatric population in the community and advanced medical care. surgical correction, as a treatment, solves this problem greatly especially with the modern surgical techniques . peribulbar block reduced the admission discharge time and reduced the burden on both the patients and the medical team. on the other hand, it carries the risk of increased intraocular pressure (iop). which, subsequently, limit its usage in glaucoma surgery . dexmedetomidine, as an alpha 2 agonist, has a well established role in decreasing intraocular pressure (iop). this effect has been shown at a histological level and clinical level . it has been tested in many studies before as an additive to local anaesthetic to augment the effect of the block and to achieve an accepted level of patient sedation (\*\*). many routes have been tested such as intravenous infusion, intramuscular injection and topically with the local anaesthesia . there is a debate about the best route and the optimum dose that can achieve the desired clinical effect with the least side effects. there is no study, till now, has examined the effect of dexmedetomidine in a diseased eye with pathology that leads to increased iop. this study states the hypothesis that dexmedetomidine locally as an additive to local anaesthesia in different doses, not only will increase the duration of the block or achieve some level of sedation, but also can reduce the iop in this diseased eye to a level that will help the surgical conditions and improve the surgical outcome.

Eligibility criteria:
inclusion criteria: * any patients who were asa i-iii, age more than 25 and less than 80 with diagnosed increased intraocular pressure and were legible for surgical correction exclusion criteria: * patients with known allergy to the medications to be given, asa more than iii, age less than 25 or more than 80, dementia, deafness, psychological disease, difficult to communicate, cannot lay flat, inr more than 1.7 or with significant coagulopathy
the clinical trial protocol for the inactivated poliomyelitis vaccine made from sabin strains

Conditions: Poliomyelitis

Summary: the purpose of this study is to evaluate the safety and the immunogenicity of inactivated poliomyelitis vaccine made from sabin strains by different does.

the sabin ipv was manufactured with poliovirus type1, 2, 3 sabin strains and vero cells by micro-carrier culture in 550 liter bioreactors. the virus suspension was harvested ,ultra-concentrated, purified and inactivated with formalin. three formulations a,b,c of sabin ipv were used, the dag contents for a were type1 45,type2 64,type3 67.5 du /0.5ml/per dose; for b 30,32,45 du/0.5ml/per dose; for c 15,16,22.5 du/0.5ml/per dose. this is a randomized, double-blind, placebo control phase 1 clinical trial. total 130 individuals were selected ,including adults (n=20), children(n= 20) and infants(n= 90). adults were randomized to two groups a1(n=10) and a2(n=10).group a1 received one dose of b ,one month later group a2 received one dose of a for safety observation. children were randomized to two groups c1(n=10) and c2(n=10) and followed the same vaccination and safety observation procedures as adults. infants were randomly allocated to three groups i-1,i-2,i-3 for safety and immunogenicity study. group i-1 were vaccinated with three doses of c(n=15) or placebo (n=15) on day 0,30,60,serum samples were collected before and 30 days after dose 3 for detecting neutralization antibody. the same procedures were followed by groupi-2 for b and group i-3 for a as groupi-1 with 30 days intermission.

Eligibility criteria:
inclusion criteria: * males and females, age from 60 days to 60 years old; * routine blood assaying (white blood cell, red blood cell, hemoglobin), liver (alanine transaminase)and kidney(blood urea nitrogen) functions are normal before vaccination; * adults, parent(s) or guardians are able to understand and sign informed consent for participation; * participants or guardians are able to attend all planned clinical appointment and obey and follow all study instructions; * infants no vaccinated with poliovaccine or other preventive biologicals in recent 7 days; * axillary temperature ≤37℃. exclusion criteria: * have medical record of participants or their family on allergy, convulsion, falling sickness, encephalopathy and psychopathy; * abnormal results of routine blood assaying (white blood cell, red blood cell, hemoglobin), liver (alanine transaminase)and kidney(blood urea nitrogen) functions before vaccination; * low platelet or bleeding disorder do not allow vaccination into the muscle; * have damaged or lower immunological function; * received blood, plasma or immunoglobulin treatment since birth; * have inborn abnormality, develop obstacles or clinical diagnostic serious chronic ( down syndrome, diabetes, sickle cell anemia or neural guillain-barre syndrome ).

Keywords: inactivated poliomyelitis vaccine sabin strains poliomyelitis
optimizing closed incision negative pressure wound therapy in emergency laparotomy

Conditions: Surgical Site Infection; Surgical Wound; Surgical Wound Infection; Surgical Complication; Surgical Wound Dehiscence; Surgical Wound Haemorrhage; Surgical Wound, Healed

Summary: the purpose of this study is to find differences in rates of surgical site infections following emergency laparotomy with the use of two different incisional negative pressure wound therapy (inpwt)devices.

a multi-arm, randomized, single institution trial was conducted. all patients proposed for emergency laparotomy for different etiologies where considered eligible. patients were enrolled following signature of informed consent. excluded from this group were patients with recent previous interventions (laparotomy or minimally invasive surgery), patients not wishing a inpwt device or patients with specific contraindications to any device. later where excluded from the study patients on laparostomy, intraoperative diagnosis of irreversible disease (ex: extensive mesenteric ischemia). following enrollment patients were randomized to 3 groups - control group with standard dressings; pico group with pico® (smith \& nephew inc, andover, ma) dressing and prevena group using prevena® (kci usa, inc., san antonio, tx) dressing. following admission the patients were monitored for surgical site occurrences and other complications by the investigation team until discharge. subsequent 2 week post-operative evaluation (if patient had been discharged) was carried out in outpatient. a final consultation was made 30 days postoperatively.

Eligibility criteria:
inclusion criteria: * all patients proposed for emergency laparotomy exclusion criteria: * contra-indication for inpwt * irreversible disease diagnosis with expected short term mortality * need for a staged procedure

Keywords: inpwt incision negative pressure wound therapy emergency laparotomy general surgery surgical site infection
long-term effects of insulin plus metformin regimens on the overall and postprandial glycemic control of patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the primary objective of this study is to show that a prandial insulin regimen, consisting of premeal insulin lispro "mid mixture" (or a combined regimen of insulin lispro "mid mixture" and insulin lispro "low mixture") plus metformin will result in significantly better overall glycemic control (lower hba1c) at endpoint than once-daily insulin glargine plus metformin. insulin lispro "mid mixture" consists of 50% insulin lispro and 50% npl. insulin lispro "low mixture" consists of 25% insulin lispro and 75% npl. in a substudy of approximately 60 patients, additional data will be collected on markers associated with risk of atherosclerosis or cardiovascular disease in the context of a controlled, outpatient, high-fat test meal.


Eligibility criteria:
inclusion criteria: * have type 2 diabetes (world health organization \[who\] classification * have used one or more of the following oral anti-hyperglycemic medications-metformin or second-generation sulfonylurea (for example, glibenclamide, glyburide, glipizide, gliclazide, glimepiride) alone or in combination with one or two insulin injections per day for at least 3 months immediately prior to entering the study. patients using more than 2 insulin injections per day or subcutaneous insulin infusion prior to the study will not be eligible to participate. * have a hemoglobin a1c between 6.5% and 11%, inclusive, according to the central laboratory at visit 1. * have clinically acceptable ldl-c, in the investigator's opinion, at visit 1. * as determined by the investigator, are capable and willing to learn how to use the insulin injection pens; comply with their prescribed diet, exercise, and medication regimen; perform self-monitoring of blood glucose; and use the patient diary as required for this protocol. exclusion criteria: * have hypersensitivity to metformin or a known allergy to metformin hydrochloride, insulin lispro mm, insulin lispro lm, or insulin glargine, or excipients contained in these products. * have known metabolic or lactic acidosis. * have a history of renal transplantation or are currently receiving renal dialysis or have serum creatinine greater than or equal to 135 micromol/l (1.5 mg/dl) for males and greater than or equal to 110 micromol/l (1.2 mg/dl) for females. * have cardiac disease with functional status that is class iii or iv * have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or alanine transaminase (alt) greater than three times the upper limit of the reference range as defined by the central laboratory.
phase ii study of oral s-1 plus irinotecan in patients with advanced gastric cancer

Conditions: Gastric Cancer

Summary: to assess the usefulness of irinotecan plus s-1 therapy based on the antitumor effect and survival period. by performing a phase ii study of this combination in patients with inoperable or with postoperative gastric cancer

a multicenter open-label, single-arm, phase ii clinical trial is conducted on patients with histological stage iv gastric cancer given irinotecan plus s-1. the usefulness of this regimens as 1st line therapy for gastric cancer was evaluated by the disease-free survival rate (dfr), overall survival rate (os), incidence and severity of adverse event.

Eligibility criteria:
inclusion criteria: ・ eligibility criteria 1. histological diagnosis of gastric adenocarcinoma. 2. measurable or assessable lesions. 3. age: 18 \~ 75 years. 4. performance status (ecog): 0 \~ 2. 5. no prior chemotherapy or only one regimen of previous chemotherapy (with a washout period \>4 weeks after the final day of the previous therapy). adjuvant chemotherapy is not defined as previous therapy. 6. no history of treatment with cpt-11 or s-1. 7. no history of radiotherapy to the abdomen. 8. oral intake of s-1 is possible. 9. adequate function of major organs (bone marrow, heart, lungs, liver etc.). wbc 3,500/mm3 and 12,000/mm3. hb 10.0 g/dl. platelet count 100,000/mm3. got and gpt 2.5times the upper limit of normal (excluding liver metastasis). t-bil 2.0mg/dl. creatinine \ 3 months. (11) able to give written informed consent exclusion criteria: -

Keywords: irinotecan, s-1, phase ii, gastric cancer
adjuvant chemotherapy with epirubicin, cmf, and weekly docetaxel or weekly paclitaxel in patients with resected high-risk breast cancer

Conditions: Breast Cancer; Adenocarcinoma of Breast

Summary: this study was a transnational pooled analysis of biological material from patients with resected high risk breast cancer who had received adjuvant chemotherapy with epirubicin and cyclophosphamide followed by weekly docetaxel or weekly paclitaxel.

this was a transnational analysis of biological material from patients with resected high risk breast cancer who are treated at hellenic cooperative oncology group (hecog) affiliated departments of oncology. this study was a pooled analysis of two separate sequential feasibility studies who received the below described treatment. patients who participated were 18 years old or older, women of any menopausal status who received epirubicin for 3 cycles every 2 weeks followed by 3 cycles with cyclophosphamide every 2 weeks followed 3 weeks later by 9 weekly cycles with docetaxel or paclitaxel. g-csf was given on days 2-7 of each cycle during treatment with epirubicin and cyclophosphamide. all premenopausal patients with receptor positive status received tamoxifen 20 mg p.o. daily for 5 years. all postmenopausal patients with receptor positive status were treated with anastrazole 1mg for 5 years. rt was required for all patients (pre- or post -menopausal), providing that they had either a partial mastectomy or tumor size \> 5cm and /or more than 4 positive lymph nodes, irrespectively the type of surgery (conservative or radical).

Eligibility criteria:
inclusion criteria: * histology-confirmed epithelial cancer of the mammary gland. * pre and post menopausal patients with early breast cancer and involved axillary lymph nodes (t 1-3 n1 m0) or high-risk n0 patients. a n0 patient is considered "high-risk" if she fulfills at least one of the following criteria; t\>= 2cm, estrogen receptor (er)/progesterone receptor (pgr) negative, her-2 3+, infiltration of blood or lymphatic vessels or nerves, grade 3. * white blood cell count (wbc) \> 4 x 109 / l, platelets \> 100 x 109 / l. * serum creatinine, aspartate aminotransferase (ast/sgot),alanine aminotransferase (alt/sgpt), gamma-glutamyltransferase, serum bilirubin 1.3 mg/ml inside the normal range of the participating hospital. * performance status (who) 0 or 1. * age \>=18 years * previous surgical treatment: either radical surgery or, for a partial mastectomy, a histologically confirmed safe margin of 2 cm or more and the results of the axillary node dissection available. * no evidence of significant cardiac disease exclusion criteria: * history of myocardial infarction within the previous 12 months or heart failure (including cardiac insufficiency controlled by digitalis and diuretics) or arrhythmias requiring medication or uncontrolled arterial hypertension (bp\> 200/110 mm hg). a normal baseline left ventricular ejection fraction (lvef) should be demonstrated by multigated acquisition (muga) scan or echocardiogram. * no previous antitumor chemotherapy or radiation * time from surgery 2 to 4 weeks
neuroradiolological analysis of covid-19 patients

Conditions: Covid-19

Summary: to describe the radiological presentation of brain abnormalities in covid-19 + patients


Eligibility criteria:
inclusion criteria: * adults * covid-19 + * abnormal neurological examination * who underwent a brain mri exclusion criteria: * no participation agreement * non covid-19 patients * patients covid-19 + without neurological abnormality or without mri examination

Keywords: covid-19 mri brain