Kornimate/medical-research-clean huggingface dataset:
a pharmacokinetic study of sugammadex in dialysis patients

Conditions: Renal Disease

Summary: the primary objective of this prospective study is to assess the trend of sugammadex (and its complex with rocuronium) concentration in surgical patients with routine outpatient hemodialysis. patients with end stage renal disease who are to receive general anesthesia and muscle paralysis will have their paralysis by rocuronium reversed with sugammadex. patients will then have blood drawn during their next three routine hemodialysis sessions to assess for the plasma concentration of sugammadex or the sugammadex-rocuronium complex over time.

patients with end-stage renal disease often have several additional comorbidities and stand to benefit immensely from this established superior drug. prior studies have not been able to correlate negative adverse events with sugammadex in patients with end-stage renal disease. more work needs to be done, however, to assess the fate of this renally excreted molecule. it has been shown that there is potential to clear sugammadex with high flux dialysis. we hypothesize that post-surgical patients with end-stage renal disease will see a significant decrease in plasma sugammadex concentration after routine outpatient dialysis.

Eligibility criteria:
inclusion criteria: * age \>18 years * currently on hemodialysis renal replacement therapy * to be undergoing a surgical procedure with the intent of starting hemodialysis postoperatively * to be undergoing a surgical procedure requiring general anesthesia * to have neuromuscular blockade for the surgical procedure exclusion criteria: * diagnosed with a blood-borne infection (hepatitis b or c, hiv) * allergy to rocuronium or sugammadex * planned renal transplant procedure * peritoneal dialysis patient * starting hemoglobin value of less than 8.0 g/dl * women who are currently pregnant

Keywords: sugammadex bridion hemodialysis renal disease rocuronium sugammadex-rocuronium complex
single-retainer lithium di-silicate versus zirconia resin bonded bridge for replacement of an anterior missing tooth.

Conditions: Missing Teeth

Summary: first, participants in this study will be recruit according to inclusion criteria. proper examination for the participants (clinically and radiographically). preparation for abutment tooth for resin bonded fixed partial denture. checking and verification for the restoration (trying). clinical assessment and survival evaluation of the final restoration on delivery and on follow-up every 12 weeks for 12 months.

examination and diagnosis: selection and examination of the patients according to inclusion and exclusion criteria. diagnosis of the patient's chief complaint and teeth that will be involved in this study will be done. primary alginate impressions for diagnosis on primary casts and for mounting. the patients will be asked to maintain good oral hygiene measures by using tooth brush twice daily. taking a professional pre-operative photo. tooth preparation procedure: 1. preparation of abutment tooth for resin bonded fixed partial denture according to specific standardized design for both types of final restorations. 2. after tooth preparation, the final impression will be taken for each participant using the intraoral scanner. 3. fabrication of temporary restoration using composite resin temporary material and cemented using zinc oxide eugenol free temporary cement. fabrication of final restoration: lithium di-silicate or zirconia resin bonded fixed partial denture will be fabricated according to group. clinical assessment and survival evaluation of the final restoration on delivery and on follow-up every 12 weeks for 12 months following outcome measures.

Eligibility criteria:
inclusion criteria: * all subjects are required to be: 1. from 15-50 years old, to be able to read and sign the informed consent document. 2. have no active periodontal or pulpal diseases. 3. psychologically and physically able to withstand conventional dental procedures 4. maintenance of good oral hygiene. 5. able to return for follow-up examinations and evaluation 6. patients have missing upper incisor tooth. exclusion criteria: 1. patient less than 15 or more than 50 years old 2. patient with active resistant periodontal diseases 3. patients with poor oral hygiene and uncooperative patients 4. pregnant women 5. patients in the growth stage with partially erupted teeth 6. psychiatric problems or unrealistic expectations 7. lack of opposing dentition in the area of interest 8. more than one missing tooth in the area of interest
evaluation of multifocal transcutaneous electrical stimulation for self-treatment among children with cerebral palsy

Conditions: Spastic Cerebral Palsy

Summary: the main purpose with this study is to investigate the effectiveness of a garment with integrated electrodes for multifocal transcutaneous electrical stimulation intended for treatment of spasticity in children with cerebral palsy.

the effect and use of the garment will be evaluated in single - case studies using abab design.

Eligibility criteria:
inclusion criteria: * cerebral palsy diagnosis, with spasticity as the main symptom * established gmfcs, levels 1-5 * macs level, levels 1-5 * included in the cpup \* national quality register * person should be between 4 years and up to 18 years * secured communication to and from person * neing able to convey pain or discomfort. exclusion criteria: * no treatment received within next three months before participation with botulinum toxin treatment to reduce spasticity. * the patient may not have a shunt or other medical pump that may be affected by the electrical stimulation provided by the garment.
a study of glaucoma therapy to treat open-angle glaucoma or ocular hypertension

Conditions: Open-angle Glaucoma; Ocular Hypertension

Summary: the purpose of this study is to determine whether a glaucoma therapy is safe and effective in treating patients with open-angle glaucoma or ocular hypertension.


Eligibility criteria:
inclusion criteria: * diagnosed with open-angle glaucoma (with ot without pseudoexfoliation or pigment dispersion component) or ocular hypertension * other protocol-defined inclusion criteria may apply. exclusion criteria: * under 18 * other protocol-defined exclusion criteria may apply.

Keywords: open angle glaucoma ocular hypertension
effect of duration of exposure of anesthesia with sevoflurane on emergence delirium

Conditions: Delirium on Emergence

Summary: emergence delirium which is a phenomenon seen commonly in preschool kids anesthetized with sevoflurane. restless recovery from anesthesia may not only cause injury to the child or to the surgical site, but may also lead to the accidental removal of surgical dressings, iv catheters, and drains. is one of the the purpose of the study is to find whether duration of exposure to sevoflurane has any effect on the incidence of emergence delirium.


Eligibility criteria:
inclusion criteria: * age between 1-6 years of age * receiving general anesthesia for non-surgical procedure exclusion criteria: * history of emergence delirium * severe cns disease
head and neck squamous cell carcinoma (hnscc)pet-ct pilot study

Conditions: Head and Neck Squamous Cell Carcinoma

Summary: the purpose of this study is to see how useful the information provided from positron emission tomography (pet) scans can be in the actual planning and delivery of radiation treatment to patients who have head and neck cancers. patients participating in this study, will have (in addition to their routine tests) a pet scan before and during their radiation treatment. following the intervention, patients will be followed as per standard practice.


Eligibility criteria:
inclusion criteria: * non-nasopharynx head and neck mucosal squamous cell carcinoma * radiologically evident gross disease * radiotherapy alone for curative intent * age equal to or more than 18 years old * to be eligible for the second study pet-ct scan: fdg avid tumour (or minimum suv of 2.5) on the first study pet-ct scan exclusion criteria: * nasopharynx cancer * h\&n scc skin * distant metastases (already known or if found on baseline ct-thorax) * prior malignancy within the last 5 years (exclude non-h\&n scc, bcc skin) * prior chemotherapy within the last 5 years or concurrent chemotherapy/egfr inhibitors * prior head and neck radiotherapy * inability to lie supine for study duration * pregnancy * inability to provide informed consent

Keywords: head and neck squamous cell carcinoma radiation therapy head and neck cancers
time-restricted eating in menopause and hormone-sensitive breast cancers (tremho)

Conditions: Menopause; Obesity and Overweight

Summary: this study is aimed at women currently going through menopause, either as part of the natural process (physiological menopause), or following hormonal treatment for breast cancer. there are several ways of slowing the weight gain frequently encountered in this situation, reducing the intensity of menopause-related symptoms and improving quality of life in this context. in this trial, the investigators examine the efficacy and possible adverse effects of intermittent fasting compared with a control intervention. participation lasts 14 weeks, with an optional 12-month follow-up. study participants are randomly assigned to either the intervention group or the control group. in the intervention group, study participants fast for 16 hours per day and eat over a period of 8 hours (intermittent fasting often called time-restricted eating \[tre\] 16h/8h). in the control group, the usual eating pattern is continued for 12 weeks. the main objective of the study is to evaluate the efficacy of tre in terms of weight and fat loss, improvement in metabolic profile, menopausal symptoms and bone health. in addition, the study team closely monitors any adverse effects.


Eligibility criteria:
inclusion criteria: * women with physiological menopause confirmed (group a) or induced menopause in the context of adjuvant therapy for hormone-sensitive non-metastatic breast cancers (group b) * age 40-65 years * body mass index 25-40 kg/m2 * stable weight (± 2 kg) over the previous month * eating window ≥ 12 hours (self-reported and measured during the run-in phase) * able to give informed consent and follow the study procedures for the entire duration * confident use of a smartphone and able to take regular pictures of food/drinks exclusion criteria: * on a hypocaloric restrictive diet, intermittent fasting or in a weight management program over the previous month * previous bariatric surgery or planned during the study * active eating disorder(s) or major mental illness at inclusion * psychoactive treatment with recent or planned changes of drug compound or dosage * diabetes with hypoglycemic drug(s) will be excluded, however those with prediabetes (as defined by the american diabetes association) or diabetes with no risk of hypoglycemia (i.e. treated with non-hypoglycemic drugs or without medication) will be included * active metabolic bone diseases (e.g. paget disease, osteomalacia) * shift work comprising night shifts (working between 11pm and 6am) over the previous 2 weeks or planned during the study * travel/trip to a different time zone (≥ 2-hour time difference) over the previous 2 weeks or planned during the study * enrolled in another interventional clinical trial (medication, surgery, medical device) over the previous 2 weeks or planned during the study
improving retreatment success (impress)

Conditions: Recurrent Tuberculosis

Summary: this is an open label randomized controlled clinical trial comparing two regimens for treatment of smear-positive pulmonary tb, among patients previously treated for tb. the primary objective is to determine if a moxifloxacin-containing regimen, substituting moxifloxacin for ethambutol, of 24 weeks duration is superior to a control regimen of 24 weeks duration in improving treatment outcomes in patients with recurrent tb and shortens the duration of tb treatment.

intervention arm :12 months (6 months treatment + 12 months post treatment follow up) control arm :12 months (6 months treatment + 12 months post treatment follow up) total sample size is 330.

Eligibility criteria:
inclusion criteria: * adults ≥ 18 years of age * previous history of anti-tb chemotherapy * hiv status: hiv infected and uninfected patients are allowed in the study: * all patients must agree to hiv testing to confirm hiv status. * patients already on arvs will be allowed in the study provided that the art regimen is not contraindicated with any of the study agents . * hiv infected patients at any cd4 count irrespective of art commencement and duration will be included in the study * smear positive or gene xpert positive pulmonary tuberculosis * rifampicin susceptible as determined by gene xpert at screening. gene xpert will be used to determine rifampicin resistance, hence the study team will made aware of resistance within 48 hours and prior to study enrolment. * karnofsky score greater than 70 * female candidates of reproductive potential must agree to use two reliable methods of contraception while on study: a barrier method of contraception (condoms or cervical cap) together with another reliable form of contraceptive (condoms with a spermicidal agent, a diaphragm or cervical cap with spermicide, an intrauterine device (iud), or hormone-based contraceptive) * a negative pregnancy test * laboratory parameters done at, or 14 days prior to, screening: * haemoglobin level of at least 7.0 g/dl * serum aspartate transaminase (ast) and alanine transaminase (alt) activity less than 3 times the upper limit of normal * serum total bilirubin level less than 2.5 times upper limit of normal * creatinine clearance (crcl) level greater than 60 mls/min * platelet count of at least 50 x109cells/l * serum potassium greater than 3.0 mmol/l exclusion criteria: * patients on a nevirapine (nvp)-containing art regimen at screening * pregnant or breastfeeding * received an antibiotic active against m. tuberculosis in the last 14 days (e.g. fluoroquinolones, macrolides, standard anti-tuberculosis drugs). * patients with known m. tuberculosis resistance to any of the study drugs at screening * history of prolonged qt syndrome or current or planned therapy with quinidine, procainamide, amiodarone, sotalol, or ziprasidone during the intensive phase of tuberculosis treatment. * known allergies or intolerance to any of the study drugs.
montelukast added to standard therapy for acute asthma in children age 6-14 years

Conditions: Asthma

Summary: oral montelukast is helpful in chronic asthma. the purpose of this pediatric study was to investigate whether the addition of oral montelukast to standard therapy for acute asthma exacerbations results in further improvement in breathing function over three hours.

we hypothesized that children with moderate acute asthma exacerbations receiving oral montelukast in addition to standard therapy will have at least 12% greater fev1 improvement in three hours than those receiving standard therapy alone. in this randomized double-blind placebo-controlled study, we enrolled emergency patients aged 6-14 years with moderate acute asthma exacerbations (initial pefr 40-70% predicted). subjects received montelukast 5-mg or placebo orally then standard therapy consisting of weight-based doses of nebulized albuterol, nebulized ipratropium bromide, and oral corticosteroids. we measured fev1 before study medication administration and hourly for three hours. we conducted a planned an interim analysis after approximately one-half of the estimated sample had been enrolled.

Eligibility criteria:
inclusion criteria: * seeking care in ed for acute asthma exacerbation * age 6-14 years inclusive * initial fev1 = 40-70% predicted (defined as moderate severity) * consent to participate in study exclusion criteria: * severe exacerbation requiring immediate therapy as determined by treating clinician * pregnancy by history * cystic fibrosis by history * tuberculosis * gastroesophageal reflux disease requiring medications * acute or chronic liver disease * bronchopulmonary dysplasia * premature \<34 weeks gestational age by history * having used leukotriene-modifying medication within 48 hours * having used theophylline within four weeks * unable to perform fev1

Keywords: acute asthma child pediatric emergency oral montelukast forced expiratory volume in one second fev1
a study of cidofovir in the treatment of cytomegalovirus (cmv) of the eyes in patients with aids

Conditions: Cytomegalovirus Retinitis; HIV Infections

Summary: incomplete closed protocol


Eligibility criteria:
information not available
the effect of home blood pressure measurement on the management of hypertension

Conditions: Hypertension; Blood Pressure; Home Blood Pressure Measurement; Ambulatory Blood Pressure

Summary: home blood pressure measurement has been reported to be associated with better clinic blood pressure and daytime blood pressure control. however, no study has evaluated the association between home blood pressure measurement and control of 24-hour ambulatory blood pressure in real world practice. the purpose of the present study is to investigate the effect of home blood pressure measurement on the control of ambulatory blood pressure in the real world. the detailed purposes of the present study are (1) to investigate the effects of home blood pressure measurement on the appropriate control of 24-hour ambulatory blood pressure in hypertensive patients treated with antihypertensive drug, (2) to evaluate the effect of home blood pressure measurement on the occurrence of cardiovascular events and target organ damage, (3) to investigate the status and appropriateness of home blood pressure measurement in the real world, and (4) to investigate factors of home blood pressure measurement methods affecting the treatment of hypertension.


Eligibility criteria:
inclusion criteria: * patients with hypertension and taking antihypertensive drugs more than 1 year exclusion criteria: * secondary hypertension * hypertensive emergency and urgency * severe heart failure (nyha iii and iv) * angina with 6 months * myocardial infarction within 6 months * peripheral artery disease within 6 months * significant arrhythmia (i.e. ventricular tachycardia and fibrillation, atrial fibrillation, atrial flutter) * pregnancy * night labor, shift worker * those who are currently participating in other clinical studies * those who have taken other clinical trial drugs within the past month * according to the opinion of the researcher, those who have or may have a disease that may interfere with the completion of the study * history of drug or alcohol dependence within 6 months
protect-asuc: covid-19 pandemic response of assessment, endoscopy and treatment in acute severe ulcerative colitis

Conditions: Inflammatory Bowel Diseases; COVID

Summary: whether the perceived changes in management of acute severe ulcerative colitis during the covid pandemic are widespread, and whether they have any impact on patient outcomes

the study aims to evaluate the process, evaluation and therapy variation in management of asuc with reference to 2019 british society of gastroenterology guidelines and see whether there are any differences between ambulatory and hospital management in asuc. also to evaluate the outcomes in asuc patients managed during the covid-19 pandemic

Eligibility criteria:
inclusion criteria: * patients aged 16 -100 inclusive * acute severe ulcerative colitis based on modified truelove and witts severity index managed during the study period exclusion criteria: * patients aged 16 -100 inclusive * acute severe ulcerative colitis based on modified truelove and witts severity index managed during the study period * admission for elective colectomy * pouch or stoma
re-irradiation therapy of locally recurrent rectal cancer with carbon ion

Conditions: Rectal Cancer; Recurrent

Summary: prospective phase ii clinical study aim to explore the clinical outcome of patients with unresectable locally recurrent rectal cancer (lrrc) treated with re-irradiation by carbon ion radiotherapy (cirt)


Eligibility criteria:
inclusion criteria: * 1) pathologically confirmed rectal adenocarcinoma (including mucinous adenocarcinoma and signet-ring cell carcinoma) and lrrc confirmed by biopsy or clinical diagnosis, * 2) received a radical operation for their primary tumor and regional lymph nodes, * 3) received chemo-radiation or radiation in pelvic before cirt, * 4) received re-irradiation by cirt after their pelvic radiotherapy. exclusion criteria: * 1) received more than once prior radiotherapy in the same treatment field, * 2) time to the last radiotherapy was \<1 year, * 3) space between the lesion to organ at risk (oars) (bladder or digestive tract) was too close (\<5 mm).
initial stability of posterior maxillary implants with bicortical fixation

Conditions: Tooth Loss

Summary: the primary purpose of this study is to 1. determine whether dental implant engaging both the alveolar crest cortical bone and sinus floor using vertical stopper drill and self-threading concept (bi-cortical fixation) increases initial implant stability compared to the short implants engaging only alveolar crest cortical bone (uni-cortical fixation) and/or ones engaging both crest and sinus floor but with green stick fracture (indirect sinus lift technique), 2. study whether different surgical techniques, residual bone height, bone density, and length and width of the implants used affect initial implant stability in posterior maxilla. in addition, this study will continue to 3. compare secondary implant stability of implants fixed bi-cortically, uni-cortically and with indirect sinus lift technique at 2nd stage surgery/6 month healing and 1 year follow-up from the restoration and 4. measure amount of endo-sinus bone formation from the 1- year follow up ct (computer tomogram) scan and evaluate safety and potential post-operative complications of bi-cortical fixation and indirect sinus lift technique reported throughout the follow up periods.

the clinical trial will evaluate initial implant stability as a primary outcome measured by resonance frequency analysis (rfa) employing dental implants surgically placed in posterior maxillary bone by engaging alveolar crest and the sinus floor using vertical stopper drill and self-threading concept (bi-cortical fixation), engaging only the alveolar crest (uni-cortical fixation), and engaging alveolar crest and the sinus floor using indirect sinus lift technique (indirect sinus lift technique). the surgical procedures compared in this experiment include 3 groups: * group 1 (15 implants) short implants placed in proximity of the sinus without sinus floor involvement (unicortical fixation) * group 2 (15 implants) implants placed using indirect sinus lift technique (indirect sinus lift technique) * group 3 (15 implants) bi-cortically fixed implants intentionally engaging sinus floor beyond up to 1-2mm without graft but using stopper drill and self-threading concept (bi-cortical fixation)

Eligibility criteria:
inclusion criteria: * eligible volunteers must be at least 18 years old, partially edentulous in maxillary posterior region with 7-11 mm residual bone height under the sinus floor and be indicated for cbct scan for diagnosis and treatment planning, and of a medical risk of asa i or ii classification to participate. exclusion criteria: * patients with bone pathology, sinus infection, and who are pregnant will be excluded. implants requiring tapping, site of an implant replacement, and implant with dehiscence and/or fenestration will be excluded.

Keywords: initial dental implant stability maxillary sinus proximity bicortical fixation