Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of cryoablation in management of sialorrhea in patients with neurological disorders

Conditions: Sialorrhea; Neurologic Disorder

Summary: to evaluate safety of cryoablation of submandibular glands in management of sialorrhea in neurologically impaired populations. secondary objective: to evaluate efficacy of cryoablation of submandibular glands in management of sialorrhea in neurologically impaired populations. duration: estimation for recruitment: 12 months estimation for procedure/trial: 1 visit with an overnight observation estimation for subject follow up: 7 days, 14 days, 28 days, 90 days, and 180 days, post ablation, with ultrasound of the bilateral submandibular glands at 28 days and 180 days post ablation total expected duration for clinical trial: 2 years


Eligibility criteria:
inclusion criteria: 1. written informed consent and assent (as appropriate) obtained from the subject/caregiver who opted voluntarily to participate in the procedure 2. male or female 2 to 65 years of age 3. confirmed diagnosis of sialorrhea as documented in their medical record 4. clinically stable with no significant changes in health status in the 2 weeks before the ablation 5. patients diagnosed with cerebral palsy, or other neurological impairment documented in their medical record exclusion criteria: 1. open sores/ulcers on skin overlying the submandibular glands 2. contraindications to surgery/general anesthesia e.g; coagulopathies, life threatening arrhythmias 3. upper respiratory airway obstruction, e.g: severe dystonia 4. history of previous local surgery 5. any congenital abnormalities that may preclude cryoablation, such as vascular abnormalities or atypical size/location 6. patients that have received salivary gland botulinum toxin injections within the prior 3 months 7. subjects unlikely to complete the study as determined by the principle investigator
low-carbohydrate versus low-fat breakfast in type 2 diabetes

Conditions: Dietary Habits

Summary: the prevalence of type 2 diabetes (t2d) is increasing worldwide, with \~380 m currently suffering from this chronic, debilitating disease. t2d is characterized by high blood glucose levels in the mornings and after meals. the largest hyperglycemic spike often occurs after breakfast. targeting this meal may be a simple, feasible strategy to improve glycemic control and reduce risk for diabetes complications. it is hypothesized that consuming a low carbohydrate high fat (lchf) breakfast for 3 months, when compared to a standard low-fat breakfast will improve blood glucose control, increase satiety and improve body composition in people with t2d. this information will test whether the simple dietary strategy of limiting carbohydrates at breakfast could help in managing t2d.

a 3-month parallel-group randomized controlled trial will be conducted. eligible participants will be randomized to either the low-carb high-fat breakfast (lchf, n=41) or a low-fat "standard care" control breakfast (ctl, n=41), to be consumed daily for a period of 3 months. due to covid-19 pandemic, this study was adapted to be conducted remotely through video/telephone conference meetings between participants and study staff, along with mailing of study materials before and after the intervention for remote data collection. each group will be provided with a menu of 8 lchf breakfasts or 8 ctl breakfasts from which to choose each morning. breakfast options (designed by a registered dietitian) will be controlled in macronutrient content and calories (\~400-500 kcal), but allow for personal preference and autonomy to promote adherence.

Eligibility criteria:
inclusion criteria: * physician-diagnosed t2d of ≥1 year; * current hba1c of \< 8.5%; * bmi: \>25 kg/m2; (as of july 5, 2021, bmi cut off was expanded from 25-40 kg/m2 to higher than 25kg/m2 to facilitate recruitment) * blood pressure of \<160/99 mm hg assessed according to guidelines; * non-smoking; * not on hormone replacement therapy, corticosteroids, or anti-inflammatory medications; * 20-79 years old. exclusion criteria: * use of exogenous insulin; * taking more than 2 glucose lowering medications; * ongoing medical treatment for diseases such as cancer, auto-immune or inflammatory disease, liver or kidney disorders; * allergy, intolerance or aversion to eggs or any other dietary restrictions (e.g., vegan, breakfast skipping) that will prevent them from following the standardized study diets; * being unable to follow remote guidance by internet or smartphone * being unable to follow the controlled diet instructions;.
clinical outcomes of patients with deferred revascularization based on ffr and ifr negative coronary artery lesions.

Conditions: Coronary Artery Disease

Summary: the objective is to assess long-term clinical outcomes of patients in whom intervention of coronary lesions was deferred due to negative fractional flow reserve (ffr) and negative instantaneous wave-free ratio (ifr) in a real-world patient population and to identify factors associated with deferred target lesion failure.

fractional flow reserve (ffr) evaluates functional significance of stenosis in intermediate coronary lesions. instantaneous wave-free ratio (ifr) is considered noninferior to ffr and does not require adenosine administration. this study was done to assess long-term clinical outcomes and factors associated with target vessel revascularization (tvr) in patients with deferred revascularization based on negative ffr and ifr. retrospective analysis of medical records of 345 patients with deferred revascularization at a tertiary care hospital , from january 2012 to january 2020 will be done.

Eligibility criteria:
inclusion criteria: * patients who had intermediate to severe coronary lesions on coronary angiogram. * patients who had negative ffr \>0.80 or ifr \>0.89 and did not undergo immediate or planned revascularization on basis of negative physiologic assessment. exclusion criteria: * patients younger than 18 years of age or those having positive ffr/ifr values irrespective of revascularization status were excluded. * similarly, those who were lost to follow up and could not be traced via telephonic or were also excluded.
long-term outcomes after epigastric hernia repair in women - a nationwide database study

Conditions: Epigastric Hernia; Women With Epigastric Hernias

Summary: the aim was to evaluate outcomes after epigastric hernia repair in women on a nationwide basis. the primary outcome iss recurrence - secondary outcomes are readmission, operation for complication, risk factors for recurrence, and readmittance.

aim outcomes after epigastric hernia repair are rarely reported independently. furthermore, women have the highest prevalence of epigastric hernia repair in the age of 41-50 years. the aim of this study was to evaluate long-term outcomes after epigastric hernia repairs in women on a nationwide basis. methods nationwide database cohort study using prospectively recorded data from the danish hernia database from women undergoing elective repair for epigastric hernias, during a 4-year period (2018-2021). a 100% follow-up was obtained by combining intra-operative data with data from the national civil register (nrc). the primary outcome was operation for recurrence, secondary outcomes were readmission and operation for complications. we compared open vs. laparoscopic repairs, and subgroup analysis were made for open repairs (sutured vs. mesh).

Eligibility criteria:
inclusion criteria: * all female patients undergoing elective repair with a laparoscopic or open technique for an epigastric hernia were included. exclusion criteria: * umbilical or incisional hernias, male patients, recurrent hernia repairs, and hernia repairs performed in relation to other surgical procedures.
comparative clinical evaluation between a novel self adhesive and conventional bulk-fill composites

Conditions: Class II Dental Caries

Summary: this study aimed to evaluate the clinical performance of a novel, tooth-colored, self-adhesive bulk-fill restorative, and a conventional bulk-fill composite, for restoring class ii cavities.


Eligibility criteria:
inclusion criteria: * patients in need of restorative treatment on at least two class ii cavities in premolars or molars. * presence of proximal caries in digital x-ray with code 2 to 4 according to the radiographic international caries detection and assessment system (icdas i). * presence of proximal caries in initial or moderate stage according to the international caries classification and management system (iccms™). * only posterior teeth with class ii cavities that have antagonistic contact and at least one proximal contact. * absence of parafunctional habits. * good general health exclusion criteria: * serious medical disorders * clinical signs of bruxism, traumatic malocclusion * pregnant or breast feeding at the time of restoration placement * intolerance or allergy toward the applied restorative materials
supported exercise programme for adults with congenital heart disease

Conditions: Congenital Disorder; Heart Diseases

Summary: this study will evaluate if the introduction of a supported exercise programme can improve physical and psychological well-being for adults with congenital heart disease.

congenital heart disease (chd) describes heart defects present from birth. the majority of affected patients will require lifelong care to not only manage their medical condition, but also to offer support and guidance on living with their specific heart condition. exercise and physical activity is one such area where patients often require support and advice. recommendations are in place for health care providers to promote physical activity for this patient population. however, many health care providers find it difficult to know what level of exercise is reasonable or how to escalate current exercise programmes. the benefits of regular exercise are well known and evidence suggests that even a modest increase in physical activity can reduce morbidity, improve psychological wellbeing and protect against cardiovascular disease. this pilot study will determine the feasibility of introducing a supported exercise programme to clinical practice. the investigators aim to assess if improvements can be made in both physical and psychological well-being for adults with chd who are living in scotland. after initial assessment and baseline measurements are obtained, participants will follow a twelve week individualised programme. the investigators will keep in regular contact with the participant throughout and arrange interval and final assessments. the baseline measurements will be repeated during the final assessment at 12 weeks. investigators anticipate that the study will also help to establish a programme that will help to improve the way adults who were born with a heart condition can be supported with physical activity on a long term basis.

Eligibility criteria:
inclusion criteria: * living in scotland * diagnosis of congenital heart disease * walks less than 450 metres on a 6 minute walk test (group 1) * walks more than 450 metres on a 6 minute walk test (group 2) exclusion criteria: * no access to internet or telephone * non english speaking (if the pilot study is successful, we anticipate that materials and programmes could be translated and accessible to non english speakers) * vulnerable adults * severe aortic stenosis or severe left ventricular outflow tract obstruction (lvoto) * eisenmenger physiology (ongoing study recruitment with spvu) * currently prescribed advanced pulmonary vasodilator therapy

Keywords: exercise physical activity
biological factors in predicting response to treatment in patients with esophageal cancer or rectal cancer

Conditions: Colorectal Cancer; Esophageal Cancer

Summary: rationale: studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. it may also help doctors predict how patients will respond to treatment. purpose: this clinical trial is studying how well biological factors work in predicting response to treatment in patients with esophageal cancer or rectal cancer.

objectives: primary * analyze various biological factors that can be used as markers to predict response to treatment and correlate with the signaling pathway of egfr. secondary * establish a tissue bank to store information about the response to treatment and survival. outline: patients undergo endoscopy, 11 biopsies of tumor tissue, and 3 biopsies of healthy mucosa. blood samples are also collected. samples are analyzed for the expression of 4 receptors in the egfr family, polymorphisms at intron 1 of the egfr gene, and gene mutations in downstream signaling pathways. after surgery, patients are followed every 3 months.

Eligibility criteria:
disease characteristics: * histologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus or rectum * planning to receive neoadjuvant treatment, including radiotherapy or chemoradiotherapy patient characteristics: * not pregnant or nursing * no blood disorder * not deprived of freedom or protected by law prior concurrent therapy: * see disease characteristics

Keywords: adenocarcinoma of the esophagus squamous cell carcinoma of the esophagus adenocarcinoma of the rectum recurrent rectal cancer stage i rectal cancer stage ii rectal cancer stage iii rectal cancer stage iv rectal cancer recurrent esophageal cancer stage i esophageal cancer stage ii esophageal cancer stage iii esophageal cancer stage iv esophageal cancer
cardiac strain using speckle tracking echocardiography during orthotopic liver transplantation

Conditions: Liver Transplant Disorder; Reperfusion Injury

Summary: researchers are trying to improve the understanding of systolic function of the heart at the time of liver reperfusion in patients undergoing orthotopic liver transplantation.


Eligibility criteria:
inclusion criteria: * age greater than 18 years * undergoing primary orthotopic liver transplantation exclusion criteria: * redo orthotopic transplantation * acute or fulminant liver failure * patient with pre-existing atrial fibrillation or hypertrophic cardiomyopathy * patients with an abnormal preoperative stress test (ef \<55%, areas of prior infarct, ongoing ischemia)
nab-paclitaxel compared with docetaxel followed by anthracyclines and cyclophosphamide in the neoadjuvant breast cancer

Conditions: Breast Cancer

Summary: this study is an open, multicenter, randomized controlled clinical trial for patients with newly diagnosed primary invasive breast cancer and clinical stage of t2 or above. the main purpose of this study is to evaluate the efficacy of dose-dense nab-paclitaxel compared with dose-dense docetaxel followed by anthracycline and cyclophosphamide in the treatment of hr positive and her-2 negative breast cancer. the effectiveness and safety of the treatment.


Eligibility criteria:
inclusion criteria: * 1) age: 18-70 years old, female; 2) patients with primary breast cancer, t2 or above, diagnosed by histopathology; 3) hr was positive and her-2 was negative by ihc; 4) according to the recist 1.1 standard, there should be at least one measurable objective focus with tumor diameter \> 2cm; 5) ecog physical fitness score 0-1; 6) lvef≥55%； 7) bone marrow function: neutrophil ≥ 1.5 × 109 / l, platelet ≥ 100 × 109 / l, hemoglobin ≥ 90g / l; 8) liver and kidney function: serum creatinine ≤ 1.5 times the upper limit of normal value; ast and alt ≤ 2.5 times the upper limit of normal value; total bilirubin ≤ 1.5 times the upper limit of normal value, or patients with gilbert's syndrome ≤ 2.5 times the upper limit of normal value; 9) patients have good compliance with the planned treatment, can understand the research process of this study and sign the written informed consent exclusion criteria: * 1) previously received cytotoxic chemotherapy, endocrine therapy, biological therapy or radiotherapy for any reason; 2) patients with stage iv metastasis at the initial diagnosis; 2) new york heart association (nyha) rating of patients with heart disease above grade ii (including grade ii); 3) patients with serious systemic infection or other serious diseases; 4) patients who are known to be allergic or intolerant to chemotherapy drugs or their adjuvants; 5) in the past 5 years, there have been other malignant tumors, except the cured carcinoma in situ of cervix and skin cancer without melanoma; 6) pregnancy or lactation, as well as childbearing age patients who refuse to take appropriate contraceptive measures during the trial; 7) participated in other experimental studies within 30 days before the administration of the first study drug; 8) patients not suitable for the study were judged by the researchers.
life skills improved in children with down syndrome after using assistive technology

Conditions: Down Syndrome; Adaptive Behavior; Quality of Life

Summary: enhancing independence and quality of life are key modifiable outcomes that are short- and long-term goals for children with down syndrome (ds) and for their parents. the study investigated the efficacy of assistive technology in improving children with down syndrome's independence and quality of life. using a commercially available assistive technology, the maphabit system, the investigators implemented the software with participants' families for 4 weeks. the investigators hypothesized that the assistive technology will improve adaptive behavioral skills and overall quality of life.


Eligibility criteria:
inclusion criteria: * down syndrome diagnosis * age between 7-17 * internet access * proficiency in english exclusion criteria: * ages outside of 7-17 * located outside of the united states of america * no internet access * no proficiency in english

Keywords: down syndrome assistive technology adaptive behavioral skills
endophthalmitis after intravitreal injection of antiangiogenic agents or corticosteroids, a cohort study of the french population of patients who received injections over 9 years

Conditions: Intravitreal Injection

Summary: intravitreal injections (ivi) of antiangiogenic agents (aa) have revolutionized the management of age-related macular degeneration (amd) and diabetic macular edema (dme) in particular. approximately 600,000 aa ivis are performed each year in france. corticosteroid ivis are an alternative in the treatment of macular edema when it is diabetic or related to venous occlusion, but also due to inflammation. endophthalmitis is one of the most feared complications after ivi because of its poor prognosis, despite its low incidence (values found in the literature between 0.01% and 0.08%). ivi practices have evolved over the years based on the recommendations of specialized organizations, with the current recommendation not to use antibiotic prophylaxis. the purpose of this study is to study the effect of intravitreal injections of anti-angiogenic agents and corticosteroids on the occurrence of endophthalmitis within 28 days following an injection.


Eligibility criteria:
inclusion criteria: * adult patients within the french population who had an intravitreal injection, identified by ccam coding bglb001 * associated with the delivery of an anti-angiogenic agent or a corticosteroid, identified by the corresponding cip code * between february 2007 and november 2015 exclusion criteria: * intraocular surgery less than 42 days before the first injection, identified by the ccam procedure * risk factors for endogenous endophthalmitis identified in the 42 days preceding an ivi identified by the icd10 code
montelukast for persistent cough in young people and adults

Conditions: Persistent Cough; Whooping Cough

Summary: persistent cough is a common symptom, accounting for about 20% of referrals to outpatient chest clinics. most coughs are caused by self-limiting viral infections such as the common cold. however, 1 in 4 people with a viral infection develop a persistent cough, which can go on for several weeks. whooping cough is a common cause of persistent cough in young people and adults. although the whooping cough vaccine gives lifelong protection against severe infection, it does not appear to give such long-term protection against milder infections, which can make someone cough for many weeks. there are currently no proven efficacious treatments for persistent cough following either a viral infection or infection with whooping cough. montelukast is a medication which is already licensed for the treatment of asthma. it works by blocking the action of chemicals called leukotrienes, which make the airways of people with asthma inflamed and sensitive. there is strong evidence to suggest that leukotrienes are also involved in causing persistent cough following viral or whooping cough infection. montelukast may therefore also help settle persistent coughs in these settings. over 18 months, we will recruit patients aged 16-49 years with a cough lasting 2-8 weeks from general practices in england. an oral fluid sample will be taken from each participant to be tested for whooping cough. participants will be randomly allocated to receive a 28-day course of montelukast or placebo tablets and asked to complete a daily cough diary for two weeks. they will be assessed after two weeks by their gp (face-to-face) and after four weeks by another member of practice clinical staff (telephone). some participants will be given a 24-hour cough monitor to wear on study entry and at two-week follow-up. this study will be funded by the national institute for health research's school of primary care.


Eligibility criteria:
inclusion criteria: * male or female, aged 16 years to 49 years inclusive. * presenting with a persistent cough of 2-8 weeks' duration without an established diagnosis (e.g. asthma, gastro-oesophageal reflux). * able to complete cough diary and study questionnaires. exclusion criteria: * there is a contraindication to montelukast. * chronic severe disease which may cause persistent cough (eg cystic fibrosis, bronchiectasis, cardiac failure). * immunodeficiency/immunocompromised state. * pregnancy. * breastfeeding. * current smoker (i.e. stopped smoking less than 6 months ago). * regular medication associated with persistent cough (ace inhibitors). * the individual is in another clinical research study.

Keywords: montelukast persistent cough adults double-blind randomised placebo controlled trial
evaluation of extended intravenous of beta-lactams in the treatment of serious gram-negative infections in critically ill patients

Conditions: Gram-Negative Bacterial Infections

Summary: the purpose of this study is to evaluate the pk/pd parameters, safety and efficacy of extended infusion of beta-lactams in intensive care patients who are infected with gram-negative bacteremia or pneumonia at national taiwan university hospital (ntuh).


Eligibility criteria:
inclusion criteria: * adult patients (\> 18 years) * admitted on the intensive care unit * starting a treatment with beta-lactams antibiotics * signed informed consent * expected to live \> 3 days exclusion criteria: * renal insufficiency (estimated clearance \< 20 ml /min) * renal replacement therapy * anc \< 1000 103 µl * pregnancy * drug abuse

Keywords: focus of study