Kornimate/medical-research-clean huggingface dataset:
natural orifice translumenal endoscopic surgery: laparoscopic-assisted transvaginal cholecystectomy

Conditions: Cholelithiasis

Summary: to determine the feasibility, safety, and efficacy of a novel minimally invasive approach to cholecystectomy and to establish a description of this novel translumenal technique in humans at this institution.


Eligibility criteria:
inclusion criteria: * females who are postmenopausal or who no longer wish to bear children * females \>25 years old and \<65 years old * diagnosis of biliary disease requiring cholecystectomy * american society of anesthesiology (asa) class i or ii * females who are able to understand and willing to sign an informed consent document exclusion criteria: * pregnancy * bmi \>= 30 * patients who are still interested in childbearing * patients taking immunosuppressive medications or who are immunocompromised * patients with acute cholecystitis or history of acute cholecystitis ( as defined by right upper quadrant pain with history of fevers and/or elevated white blood cell count and/or positive ultrasound findings, ie, gallbladder wall thickening or pericholecystic fluid) * patients with suspicion of gallbladder cancer * patients with history of previous open abdominal surgery * patients with untreated common bile duct stones

Keywords: female cholelithiasis natural orifice surgery laparoscopic- assisted transvaginal
evaluation of a web-based intervention to promote physical activity in patients with heart disease.

Conditions: Coronary Artery Disease (CAD)

Summary: a randomized control trial (rct) is planned to evaluate a web-based intervention (cardiofit) against usual care in increasing physical activity levels in patients with coronary artery disease (cad). we hypothesize that compared to usual care, participants in cardiofit will; a) have increased physical activity levels, b) will have a higher health-related quality of life at measurement dates and, c) will have greater improvements in psychosocial predictors.

most existing cardiac rehabilitation programs have little ability to expand participation using traditional delivery models that emphasize supervised, facility-based programs. futhermore, facility based programs to promote physical activity behavior in patients with coronary artery disease (cad) are limited in their impact because most patients are unwilling to travel more than 30-40 minutes to participate in a program. cardiofit is an off-site, 26 week web-based physical activity coaching service for people with heart disease. within the cardiofit program, patients will be assigned to an on-line "coach" and receive customized exercise programs based on their medical history, personal goals and preferences. a randomized control trial (rct) is planned to evaluate the effectiveness of the web-based intervention at increasing physical activity levels against usual care in patients with cad. this study is in the third phase of a three-phase research program to examine interventions to promote physical activity for the secondary prevention of cardiovascular disease.

Eligibility criteria:
inclusion criteria: * age 20 to 80 years * english proficiency * internet access (home or work) * documented cad (most recent cardiac diagnosis); documented myocardial infarction (mi), successful pci procedure exclusion criteria: * patient intends to enroll in structured cardiac rehabilitation * hospitalization for coronary artery bypass (cabg) * hospitalization for diagnostic procedure not associated with previously documented mi * patient coming back to hospital for planned staged pci within 6 months * cardiac transplantation * presence of, or hospitalization for defibrillator implant * hospitalization for pacemaker implantation * unresolved unstable angina \&/or hospitalization for angina (without mi or pci) * uncontrolled arrhythmias causing symptoms or hemodynamic compromise * neuromuscular, musculoskeletal or rheumatoid disorders that are exacerbated by exercise * other uncontrolled metabolic conditions (e.g. diabetes) * chronic infectious diseases such as mononucleosis, hepatitis, aids * acute systematic illness or fever * uncontrolled tachycardia (\<120 bpm) * uncompensated congestive heart failure (\&/or nyha class iii, or iv) * 3rd degree av block without pacemaker * active pericarditis or myocarditis * recent embolism * suspected or known aaa aneurysm \> 4cm * uncontrolled hypertension (sbp \> 200; dbp \> 110) * pregnancy

Keywords: randomized control trial exercise intervention prevention rehabilitation
parent training to enhance social success for children with autism spectrum disorder

Conditions: Autism Spectrum Disorder

Summary: children with autism spectrum disorder (asd) exhibit characteristic deficits in social initiation and there are no empirically validated treatments specifically for this core deficit. while parent training is known to be a critical intervention component, few social skills programs involve parents. this study will capitalize on an existing social skills group already established at the community agency abilities united, with the goal of enhancing the program's effectiveness by adding a parent component. specifically, the proposed study will investigate whether a novel parent mediated social skills program (social success), which provides parent training in conjunction with a social skills group intervention, will result in more frequent initiations during play with typically developing peers. participants will include 50 children with asd age 4:0 to 6:11 years. children will be randomly assigned to either social success (n=25) or waiting list (n=25). treatment will be provided for 8 weeks during a weekly 120-minute social skills group at abilities united. the study will evaluate the effects of social success on areas of core social deficit including frequency of peer initiations using parent ratings, observational measures, standardized questionnaires, and a social eye tracking task. outcomes will be compared to a waiting list control group. findings will be disseminated through presentations and publications to aid clinicians in providing more effective social skills treatment for children with asd and to enhance the scientific knowledge-base related to evidence-based social skills treatments. this research designed with the goal of stimulating additional scientific inquiry in the area of treatment for core social deficits in asd and will provide a strong foundation for larger scale grants to study motivation-based interventions to improve social functioning.


Eligibility criteria:
inclusion criteria: * child aged 4.0 to 6.11 years * child diagnosed with asd (autism diagnostic observation schedule; ados-2) * child without intellectual disability (stanford binet intelligence scales; sb-5) * parent able to consistently participate in parent training sessions and complete study measures exclusion criteria: * child with other severe psychiatric disorder * child with known genetic condition (e.g., fragile x, retts) * child with unstable medical condition (e.g., active seizures)

Keywords: parent training social skills
effect of tri calcium phosphate on efficacy and sensitivity with vital tooth whitening using 20% carbamide peroxide

Conditions: Tooth Sensitivity

Summary: teeth sensitivity is the most popular symptom when using at-home tooth whitening. tri calcium phosphate containing pastes may affect the efficacy and postoperative sensitivity associated with at-home vital tooth whitening using 20% carbamide peroxide

subjects enrolled in this study will apply home bleaching trays with 20%carbamide peroxide 4h/day for a week, the sample will be divided into two groups : the experimental group will apply tri calcium phosphate containing paste(clinpro) 30 min/day after bleaching treatment, the control group will apply placebo paste 30 min/day after bleaching treatment,

Eligibility criteria:
inclusion criteria: * good dental health * six maxillary anterior teeth present and healthy with no restorations or carious lesions * teeth darker than vita a2 shade * no history of teeth sensitivity * no use of a desensitizing agent or desensitizing toothpaste in the past three months exclusion criteria: * active caries or periodontal disease * allergies to bleaching agent or tray material * pregnancy and breastfeeding during the trial * tetracycline-stained teeth or fluoride or non-vital teeth * smoker * using tooth bleaching products during the last 3 years

Keywords: tooth sensitivity tri calcium phosphate at-home whitening
2-year therapy with teriparatide vs 1-yr therapy followed by 1-year of raloxifene or calcium/vit d in severe postmenopausal osteoporosis

Conditions: Osteoporosis, Postmenopausal

Summary: the primary purpose of the study is to compare 3 different osteoporosis therapies following one year of teriparatide.in the first year,all eligible patients received open-label teriparatide 20 micrograms/day.after 1 year, patients are randomly assigned to one of 3 possible follow-up treatment regimens for the second 12 months: continuation of teriparatide, switch to raloxifene, or no pharmacological treatment(other than the calcium and vitamin d supplements that everyone receives). patients are stratified into 3 subsets: (a) patients who have never received any anti-osteoporosis treatment before; (b) patients who received prior antiresorptive treatment successfully; (c) patients who failed to respond adequately to prior antiresorptive drugs (such as bisphosphonates or raloxifene) in the past. these latter patients are not randomized at month 12 but will continue treatment with teriparatide 20 micrograms/day throughout the second year.


Eligibility criteria:
inclusion criteria: * ambulatory women greater or equal to 55 years, at least 2 years postmenopausal. * lumbar spine or total hip or femoral neck bone mineral density measurement must be at least 2.5 standard deviations (sd) below the average bone mass for young women (t-score -2.5 or less). * presence of at least one known and documented preexisting clinical fragility fracture, in the past 3 years. patients may be included in substudy 2 if they meet any one of the following additional criteria - patients who have sustained at least one new fragility fracture (vertebral or nonvertebral), despite prescription of antiresorptive therapy\* during the 12 months prior to the last new fracture or patients who, after a minimum of two years after initiating antiresorptive therapy\*, either have a lumbar spine, femoral neck, or total hip bmd of at least - 3sd below the average bone mass for young women (t-score -3 or less), or who show a decrease of at least 3.5% in bmd at any one of these sites. \*antiresorptive therapy includes all bisphosphonates, raloxifene, ert/hrt, calcitonin, and vitamin d metabolites. exclusion criteria: for substudy 1 patients only: * current or history of vaginal bleeding or spotting of unknown cause in the 1 year prior to study start * currently suspected or history of venous thrombotic events (vte), including lower extremity thrombosis, and other major venous thromboses, or high risk of developing vte as assessment by the investigator. treatment with * vitamin d \>50,000 iu/week or with any dose of calcitriol or vitamin d analogs or agonists in the 6 months prior to visit 2 * fluorides in the 12 months prior to visit 2. * systemic corticosteroids (other than for replacement therapy) in the 1 month prior to visit 2.(ophthalmic, otic topical, orally inhaled, nasally inhaled, or intra-articular corticosteroid therapy may be used without these restrictions.)
comparison of the coughing frequency of remimazolam total intravenous anesthesia versus inhalational anesthesia

Conditions: Thyroid Neoplasm; Cough

Summary: this study is a randomized controlled trial. adult patients undergoing thyroidectomy under general anesthesia at severance hospital and yonsei cancer center are included in tis study. for intervention group, patients receive anesthesia with total intravenous remimazolam, while for control group, patients receive anesthesia with inhalation anesthetic. the primary end point of the study is to determine whether coughing during endotracheal tube extubation is less when anesthesia is maintained with intravenous remimazolam compared to inhalation anesthetics. the secondary end points are cough score (graded into 4 levels), frequency of reoperation due to postoperative bleeding, these include the frequency of hypertension during the extubation process and whether additional painkillers are used in the recovery room.


Eligibility criteria:
inclusion criteria: adult patients aged 19 years or older undergoing thyroidectomy under general anesthesia at severance hospital cancer center. exclusion criteria: * patients with american society of anesthesiologists physical status classification iv or higher. * patients who are hypersensitive to remimazolam or inhalational anesthetic. * patients with structural abnormalities in the upper airway or respiratory diseases. * patients with a history of upper respiratory tract infection within the past 2 weeks. * current smoker * pregnant * patients who have difficulty reading and understanding the informed consent form
impact of ophthalmic surgeon experience on early postoperative central corneal thickness

Conditions: Cataract

Summary: to assess the impact of surgeon experience on early postoperative central corneal thickness (cct) in eyes that have undergone phacoemulsification-based cataract surgery.

cataract surgery is the most commonly performed surgical procedure. although phacoemulsification is considered a safe method of performing cataract surgery, the risk of endothelial cell loss (ecl) remains. given that the surgical technique and speed typically improve with surgeon skill and experience, the purpose of this study was to evaluate the impact of surgeon experience on the occurrence of ecl, as reflected by the presence of corneal edema.

Eligibility criteria:
inclusion criteria: * presence of senile cataract * age above 50 years * history of visual acuity regression exclusion criteria: * presence of white or brown cataract * history of previous ophtalmic surgery * preexisting corneal pathology (cornea guttata, infectious keratitis or active inflammatory or old) * patients who developed intraoperative complications

Keywords: surgeon experience endothelial cell loss
the evaluation of the efficacy and tolerability of faslodex (fulvestrant) and aromasin (exemestane) in hormone receptor positive postmenopausal women with advanced breast cancer

Conditions: Locally Advanced Breast Cancer; Metastatic Breast Cancer

Summary: the purpose of this study is to compare the efficacy of faslodex (fulvestrant) to aromasin (exemestane) in hormone receptor positive postmenopausal women with advanced breast cancer. patients will be treated until disease progression or until the investigator has determined that treatment is not in the best interest of the patient, whichever occurs first.


Eligibility criteria:
inclusion criteria: * biopsy confirmation of breast cancer * breast cancer has continued to grow after having received treatment with an aromatase inhibitor * postmenopausal women defined as a women who has stopped having menstrual periods * evidence of hormone sensitivity * written informed consent to participate in the trial exclusion criteria: * previous treatment with faslodex (fulvestrant) or aromasin (exemestane) * any hormonal therapy used to modify the course of an additional medical condition after prior treatment with a non-steroidal aromatase inhibitor * treatment with an investigational or non-approved drug within one month * an existing serious disease, illness, or condition that will prevent participation or compliance with study procedures * a history of allergies to any active or inactive ingredients of faslodex or exemestane (i.e. castor oil or mannitol)

Keywords: locally advanced breast cancer metastatic breast cancer breast cancer cancer of breast cancer of the breast
grk4 polymorphisms blood pressure response to candesartan

Conditions: Essential Hypertension

Summary: the purpose of this study is to investigate the association between grk4 polymorphisms and essential hypertension in southwestern han chinese and test whether these polymorphisms were associated with the changes in blood pressure in patients with essential hypertension treated with angiotensin ii type antagonist candesartan.

all antihypertensive agents were withdrawn before the start of a 4-6 week, single-blind, after which the patients received candesartan 10 mg or 20mg once daily as monotherapy in a single-blind fashion. the doses were doubled after 1 weeks if dbp was ≥ 90 mmhg.

Eligibility criteria:
inclusion criteria: * men and women with mild to moderate essential hypertension in southwestern han chinese exclusion criteria: * subjects unwilling to participate or subjects did not have all measurement required, * subjects who were on medications, which affect blood pressure or * whose dna failed to amplify and 8 with errors in mendelian segregation

Keywords: men and women in southwestern han chinese
phase i / ii study of irinotecan (cpt-11) combined with l-leucovorin (l-lv) and 5-fu in patients with advanced colorectal cancer

Conditions: Colorectal Cancer

Summary: we performed a phase i/ii study of cpt-11/5fu/l-lv in advanced colorectal cancer, to determine the optimal dose of cpt-11 and to estimate the safety and efficacy of this regimen

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

Eligibility criteria:
inclusion criteria: 1. histological diagnosis of colorectral adenocarcinoma. 2. measurable or assessable lesions. 3. age: 18 \~ 75 years. 4. performance status (ecog): 0 \~ 2. 5. no prior chemotherapy. adjuvant chemotherapy is not defined as previous therapy. 6. no history of radiotherapy to the abdomen. 7. 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 \<1.5 mg/dl normal ecg (not considering clinically unimportant arrhythmias and ischemic changes). 8. predicted survival for \>3 months. 9. able to give written informed consent. exclusion criteria: 1. severe pleural effusion or ascites. 2. metastasis to the central nervous system (cns). 3. active gastrointestinal bleeding. 4. active infection. 5. diarrhea (watery stools). 6. uncontrolled ischemic heart disease. 7. serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure). 8. active multiple cancer. 9. severe mental disorder. 10. pregnancy, possible pregnancy, or breast-feeding. 11. flucytosine treatment 12. gilbert's syndrome. 13. judged to be ineligible for this protocol by the attending physician.

Keywords: irinotecan, leucovorin, fluorouracil, phasei/ii, colorectal cancer,
amlodipine freeze-dried powder for oral solution 5 mg

Conditions: Hypertension; Coronary Artery Disease

Summary: the goal of this clinical study is to assess the relative bioavailability of amlodipine for oral solution 5 mg of brillian pharma inc. under fasting and fed conditions versus reference product norvasc 5 mg tablets of pfizer labs under fasting in normal, healthy, adult, male, primary objective: 1. to compare the relative bioavailability. 2. to assess the food effect in test product (t1) (fast) vs test product (t2) (fed) amlodipine oral solution 5 mg of brillian pharma inc. secondary objective: to monitor the safety and tolerability of a single oral dose of investigational medicinal products (imps).

a total of 24 healthy, adult, male and female human volunteers will be enrolled. excluding the screening period, the duration of the clinical phase will be approximately 50 days including a washout period of at least 21 days for each study period. this study is being conducted in healthy, adult, human subjects under fasting and fed conditions as per usfda and nmpa guidelines. the present study will be conducted to assess the relative bioavailability of the test product versus the reference product under fasting conditions. the study also assesses the effect of food on the bioavailability of amlodipine fd-pos 5 mg (powder in a unit-dose container) product.

Eligibility criteria:
inclusion criteria: * adult, healthy
exploratory study of the expression of the serotonergic 5-ht4 receptor in parkinson's disease

Conditions: Parkinson Disease

Summary: the research aim to study in detail the motor, cognitive and affective modifications of parkinsonian patients (compared to control subjects) at a moderate stage of the disease and to analyze by positron emission tomography (pet) imaging with the specific radioligand \[11c\]sb207145 the expression levels of this 5-ht4 receptor. at the same time, the study will monitor the impact of the 5-httlpr polymorphisms of serotonin transporter (sert) and brain-derived neurotrophic factor (bdnf) val66met on the expression of the 5-ht4 receptor in subjects.


Eligibility criteria:
inclusion criteria: * man or woman : age between ≥ 50 and ≤ 85 years old * for women: postmenopausal * affiliated to a social security scheme or similar; * having given written consent to participate in the free and informed study. * level of study: ≥ 6 years of schooling * only for healthy volunteer : no history of neurological or psychiatric disease * only for patient : having a clinically established or probable diagnosis of parkinson's disease according to the criteria defined by the movement disorder society at a hoehn and yahr stage ≤ 3 (in on dopa conditions) and a duration of evolution of the disease between 2 and 8 years. * only for patient : having a moca (montreal cognitive assessment) ≥ 20/30. exclusion criteria: * diagnosis other than parkinson's disease ( for patient only) * treated with specific serotonin inhibitors (ssris), specific noradrenaline inhibitors (snris), tricyclic antidepressants, monoamine oxidase inhibitors (maois) and neuroleptics in the last 3 months * use of recreational drugs interfering with the serotonergic system (ecstasy, mdma) or opioids (cannabis, opiates) in the last 3 months or chronic use * contraindication to magnetic resonance imaging (mri) or positron emission tomography (pet) * participation in the last year to a study using ionizing radiation or concomitant participation in another research project involving the human being that may interfere with the results or the conclusions of this study * exceeding the annual amount of compensation authorized for participation in research protocols * deprivation of liberty by judicial or administrative decision, person subject to a legal protection measure * bmi ≥ 35kg/m2 * presence of depression (bdi-2 score ≥21), anxiety (parkinson anxiety scale (pas) score ≥14) or apathy (starkstein score ≥14) - (for healthy volunteers only) * cognitive impairment (moca score ≤26) (for healthy volunteers only) * current or past neurological or psychiatric pathology (for healthy volunteers only) * serious and progressive medical pathology * current or past dependence on any addictive substance according to dsm-v (the diagnostic and statistical manual of mental disorders) criteria (alcohol, cannabis, hallucinogens, inhalants, opiates, sedatives, stimulants), except tobacco and caffeine. (for healthy volunteers only)

Keywords: serotonergic 5-ht4 receptor radiotracer