Kornimate/medical-research-clean huggingface dataset:
blind measurement in fetal weight estimation

Conditions: Pregnancy

Summary: woman who are expected to give birth in the next 72 hours will be allocated randomly to a study group of blinded measurements for estimated fetal weight and a control group of non-blinded measurements. accuracy of estimations will be compared between the groups.

estimating fetal weight using ultrasound is an essential component in fetal medicine and prenatal treatment. a study that was conducted as a part of the intergrowth-21 project established international standards for fetal growth by documenting 3 measurements of biometry indices, which included head circumference, abdominal circumference, femur length and biparietal diameter (bpd). the measurements were not disclosed to the investigator in order to prevent bias. in a recent study it was found that use of the average of the 3 biometric measurements compared with a single measurement for the purposes of estimating fetal weight, is more accurate. however, the measurements were disclosed to the investigator. currently, no studies have examined whether there blinded measurements are significantly better than non-blinded measurements. the aim of this study is to compare blinded to non-blinded biometric measurements for estimation of fetal weight. woman who are expected to give birth in the next 72 hours will be asked to participate in the study. after singing an informed consent, participants will be randomly allocated to a study group of blinded measurements for estimated fetal weight and a control group of non-blinded measurements. estimation of fetal weight will be performed using the hadlock-4 formula in triplicate measurements. in the study group the measurement will be blinded from the sonographer and measurements will be revealed only upon completion of all measurements. in the control group, the same measurements will be conducted without blinding of the measurements during the assessment. accuracy of estimations will be compared between the two groups.

Eligibility criteria:
inclusion criteria: * singleton pregnancy * gestational age between 37 and 41 weeks * expected delivery within 72 hours exclusion criteria: * major malformations * active labor

Keywords: estimated fetal weight blinded measurements
phenotypical approach of the drug metabolizing hormones activity before and after roux-en y-gastric bypass

Conditions: Obesity

Summary: the activity of drug-metabolizing enzymes and transporters evolutes after roux-en-y gastric bypass. primary aim : to study the intra individual evolution of phenotypical markers of different drug metabolizing enzymes and one transporter (cyp1a2, cyp2d6, cyp2c9, cyp2c19, cyp3a4 and p-gp), using a cocktail phenotypic approach, after roux-en-y gastric bypass.

principal judgement criteria : phenotypical markers of enzymes and transporter activity before, at 5-8 weeks and 25-30 weeks following surgery. secondary judgement criteria : * genetic polymorphisms known to affect expression and/or activity of enzymes and transporter. * intestinal and hepatic expression and activity of the enzymes and transporter of interest. * markers of inflammation methodology, study design : open-labelled monocentric study. sample size : it will be a descriptive experimental study involving 12 subjects. study design : in centre 1: inclusion at least 2 weeks prior to surgery (v0) in centre 2: three studies of 12 hours each will occur (in addition with the usual clinical and surgical follow up) at three times periods: in the 8 weeks period before surgery (v1), at 5-8 weeks after surgery (v2) and at 25-30 weeks after surgery (v3). in centre 3: the patients will undergo gastric bypass surgery (corresponding to the usual clinical and surgical follow up) and samples of jejunum and liver will be obtain during the surgery (j0). centres 4 and 5 are involved in samples analysis.hence, patients will attend 3 visits, in addition to the usual clinical and surgical follow-up. study duration: 26 months (with duration of inclusion of 18 months) duration for a patient: 38 weeks at maximum (8 months) investigating center and participating units: one center enrolling the patients and three centers involving in the others investigations.

Eligibility criteria:
inclusion criteria: * patients with morbid obesity (imc \> 40 kg/m²) or severe obesity (imc=35-40 kg/m²) with co morbidities (sleep apnea syndrome or hypertension without treatment or steatosis hepatitis) candidates for a gastric bypass. * patient not receiving more than two treatments whose effect on the expression of enzymes and drug transporters is zero other than vitamins. * patient agreeing to participate at three studies of one day (12 hours) occurring at three different periods. * patients aged between 18 and 60 years old. * patient giving its well-informed and free consent. * patient without allergy to any of the drugs used for test. * patients living in france during the study and with french social security exclusion criteria: * tabacco * contraception including estrogens compounds * medication other than vitamins. * allergy

Keywords: drug metabolizing enzymes and drug transporter roux-en y-gastric bypass obesity drug availability bmi over 35kg/m² and comorbidities or >40kg/m²
efficacy and safety of the association of clotrimazole and metronidazole in the treatment of vaginal discharge from different etiologies.

Conditions: Sexual Active Women; Vaginal Discharge

Summary: the purpose of this study is to determine the efficacy and safety of the association clotrimazole 200mg and metronidazole 0,75%(clopistatin 5dt®) and whether it is superior when compared with metronidazole 100mg/g (gynecologic flagyl®) and clotrimazole 20mg/g (gino-canesten® 3) in the syndromic treatment of vaginal discharge from different etiologies.


Eligibility criteria:
inclusion criteria: * subjects that have already started sexual activity; * subjects with complaints of vaginal discharge and had not received treatment in the 30 days before the enrollment visit; * subjects in the premenopausal period must be under usage of acceptable contraceptive methods(oral contraceptive, injectable contraceptives, iud, hormonal implant, hormone transdermal adhesive, tubal ligation) or are surgically sterile (bilateral oophorectomy or hysterectomy); or accept to utilize a barrier contraceptive provided by the sponsor during the period of the study; * subjects with the capacity to comprehend and understand her participation in this clinical trial, manifested through informed consent form, even if with the help of another person (legal representative). exclusion criteria: * subjects with chronic diseases (diabetes mellitus, neoplasia, renal failure, tuberculosis) or any clinical and/or laboratory find (anamnesis, physical exam and/or laboratory tests) that is interpreted, in the investigator's opinion, as a risk to the subject's participation in the clinical trial; * menopausal women; * known hyper-sensibility to any of the products' components; * pregnant or lactating women; * subjects with active genital ulcer and/or with genital herpes diagnosis; * diagnosis or suspicion of inflammatory pelvic disease; * diagnosis of vulvar condyloma acuminata; * subjects under the usage of systemic corticosteroids for a period superior than 2 (two) months or under the usage of chemotherapeutics; * transplanted subjects; * subjects with history of active autoimmune diseases or with immune suppression; * subjects under the usage of medication or therapy described on the protocol item "prohibited treatments"; * subjects that have participated on a clinical trial in the last 12 months (conselho nacional de saúde - resolução 251, de 7 de agosto de 1997, item iii, sub-item j), unless the subject can have a direct benefit, in the investigator opinion; * subject that have a kinship or bond with any employees of sponsor or research center;

Keywords: vaginal discharge women
effect of maternal age and bmi on induction of labor using oral misoprostol in late-term pregnancies: a retrospective cross-sectional study

Conditions: Induction of Labor Affected Fetus / Newborn; Pregnancy Late

Summary: to evaluate the effect of maternal age and body mass index (bmi) on oral misoprostol induction of labor for late-term pregnancies.


Eligibility criteria:
inclusion criteria: * late term pregnancies out of labor, * bishop score \< 7 exclusion criteria: * labor (defined as presence of at least three painful uterine contractions every ten minutes), * uterine tachysystole (\>5 contractions within 10 minutes for two consecutive 10-minute periods), * hypertonic uterus, * abnormal ctg, * contraindications to vaginal delivery (fetal malpresentation such as breech presentation or transverse situation, fetal macrosomia, abnormally implanted placenta, active genital herpes infection, cervical cancer), * patients with parity \> 4, * medical contraindication to misoprostol (asthma, glaucoma), * women with previous hysterotomies.

Keywords: late-term pregnancy body mass index age oral misoprostol cervical ripening induction of labor
comparative study of surgical completeness after robotic thyroidectomy versus conventional open thyroidectomy

Conditions: Papillary Thyroid Carcinoma

Summary: the robotic thyroidectomy (rt) has excellent cosmetic and several functional results. but there were no definite evidence of oncological safety of robotic thyroidectomy yet. to assure the surgical completeness of robotic thyroidectomy, the investigators compared robotic thyroidectomy and conventional open thyroidectomy (ot) by means of the postoperative radioactive iodine (rai) uptake of possible remnant thyroid tissue and stimulated tg level.


Eligibility criteria:
inclusion criteria: * age ≥ 20years * papillary thyroid carcinoma patients who underwent conventional open or robotic bilateral total thyroidectomy at yuhs(yonsei university health system) * patient who underwent postoperative low doe (30mci) rai ablation therapy at yuhs exclusion criteria: * pregnant, lactating women * patient who underwent postoperative low dose rai at another hospital * patient with distant metastasis * patient who underwent combined operation with bilateral total thyroidectomy (ex) modified radical neck dissection, selective neck node excision d/t lateral neck node metastasis * patient who underwent high dose (more than 30 mci) rai therapy
dietary polyphenols and lipid oxidation

Conditions: Obesity, Insulin Sensitivity, Type 2 Diabetes Mellitus

Summary: there are strong indications that (combinations of) polyphenols may be attractive candidates in the prevention of the metabolic syndrome and diabetes through modulation of pathways of fatty acid metabolism and mitochondrial function. we hypothesize that the combination of specific polyphenols, with partly distinct mechanisms of action, may have physiologically significant effects on fat oxidation through additive or synergistic effects, thereby improving body composition, insulin sensitivity and preventing type 2 diabetes. the following objective will be addressed in the current study: (1) to test short term (3 day) effects of combinations of polyphenols (supplements of egcg either in combination with resveratrol or with resveratrol and genistein) to affect systemic lipolysis and fat oxidation during overnight fasted conditions and after ingestion of a high fat meal in overweight subjects


Eligibility criteria:
inclusion criteria: * overweight men and women (bmi≥25kg/m2- 29.9 kg/m2), aged 30-70 years, caucasian, normal fasting glucose (\< 6.1 mmol/l) and blood pressure (systolic blood pressure 100-140 mmhg, diastolic blood pressure 60-90 mmhg), weight stable in last 3 months (± 2kg). exclusion criteria: exclusion criteria: * women lactating, pregnant or (post)menopausal, regular smokers, people with intensive fitness training, eg. athletes (≥ 3 per week ≥ 1 hour training), habitual consumption of green tea (more than 1 cup per day) or products containing green tea extract, total caffeine consumption \> 300 mg/day, alcohol intake \>20 g/day, any dietary vitamins or dietary supplements, diabetes mellitus (defined as fpg ≥ 7.0 mmol/l and/or 2hpg ≥ 11.1 mmol/l); serious pulmonary, cardiovascular, hepatic or renal disease : history of cardiovascular disease, all other relevant medical disorders that potentially interfere with this trial, current use of medication interfering with study intervention or interfering with study endpoints/hypotheses.
effects of forms of modified cit on upper extremity performance in cerebral palsy

Conditions: Cerebral Palsy

Summary: the purpose of this study will employ clinical assessment tools to examine the effects of modified constraint-induced therapy (mcit) on the more affected upper extremity of children with cerebral palsy.

the study included threefold: (1) it will employ kinematic analysis, along with clinical assessment tools to examine the effects of mcit on the more affected upper extremity of children with cerebral palsy with asymmetric motor impairments after treatment immediately and 1 year following. the clinical tools will include motor activity log (mal), bruininks-oseretsky test of motor proficiency (botmp),peabody-developmental motor scales (pdms-ii), and wee-fim. (2) this study looked at the intervention impact on bimanual coordination and the less affected upper extremity. (3) it investigated the effects of forms (group vs. individual intervention) on upper extremity performance.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of spastic cp 2. age between 4 and 10 years old 3. shoulder flexion of the affected upper limb more than 90 degrees, elbow extension over 160 degrees, wrist extension to 10 degrees at least, and fingers full flexion to 10 degrees at least 4. basic balance ability: sitting on the chair without arm support; feet stay on the floor consistently; performing the affected upper limb movement without losing balance 5. ability to follow simple oral commands 6. no related musculoskeletal surgery of the affected upper limb 7. not have injected the botox into the affected upper extremity during the past 6 months 8. no visual or auditory disability

Keywords: modified constraint-induced therapy children with cerebral palsy kinematic analysis group therapy
reducing health risk behavior and improving health in adolescents with depression

Conditions: Depression; Adolescent Health

Summary: this study will determine the effectiveness of a health education intervention in reducing health risk behavior and improving health in adolescents with depression.

depression is a common disorder among adolescents. if left untreated, it can cause significant disability, illness, and even death. teens with depression often engage in risky health behaviors, such as smoking, drug and alcohol use, unprotected sex, and unhealthy eating and exercise patterns. by reducing these health risk behaviors, depressed adolescents may be able to avoid negative health consequences and improve their physical and mental health. this study will determine the effectiveness of a health education intervention in reducing risky health behaviors in adolescents with depression. participants in this study will be invited to enroll during a visit to a participating primary care clinic. participants will be randomly assigned to either partake in a health education intervention or receive standard care. both groups will continue to receive treatment through their primary care clinic. those participants receiving standard care will be referred to special programs as needed to reduce their involvement in risky health behaviors. participants assigned to the health education intervention will attend 10 weekly education sessions that will be led by trained health educators. parents or guardians may be asked to attend sessions depending on their interest in the intervention and the age of the youth participant. topics covered will include teenage smoking, alcohol and drug abuse, risky sexual behaviors, and obesity. cognitive-behavioral strategies, role playing, and media clips will be used to stimulate discussion and involvement in the intervention. the intervention will be tailored to target the specific risky behaviors in which each participant engages. motivational interviewing will also be used to build positive attitudes to support behavior change. all participants will attend follow-up visits to assess behavior change at months 6 and 12 following study entry.

Eligibility criteria:
inclusion criteria: * cidi diagnosis of major depression or probable depression based on youth self report * availability of a family member to provide informed consent exclusion criteria: * lacks contact information (e.g., address, telephone number) * any functioning deficits or other characteristics that might interfere with study participation * currently in a living situation that might interfere with study participation (e.g., lives over 1 hour away from the study site) * lacks family available to participate in the intervention * mental retardation * does not speak english or spanish

Keywords: tobacco use alcohol and drug use obesity risky sexual behavior
effect of prophylactic ketorolac on cme after cataract surgery

Conditions: Macular Edema, Cystoid

Summary: the study will evaluate the efficacy of prophylactic administration of the topical nonsteroidal anti-inflammatory drug (nsaid) ketorolac tromethamine 0.5% (acular®) on cystoid macular edema (cme) in patients having undergone cataract surgery. cme is the most frequent cause of decreased vision after uncomplicated cataract surgery and can result in irreversible sight reduction. the investigation will involve a comparison arm and a treatment arm with both sets of patient populations being evaluated for cme with ophthalmologic examinations and optical coherence tomography (oct) measurements. the objective is to elucidate the role of nsaid drops in preventing cme after cataract surgery.


Eligibility criteria:
inclusion criteria: * first cataract surgery (i.e., first eye). exclusion criteria: * hypersensitivity to the nsaid drug class, * pregnancy.
pulmonary vein isolation with the single shot endoscopic ultra-compliant pfa balloon for the treatment of af

Conditions: Atrial Fibrillation (Paroxysmal)

Summary: this is a prospective, single-arm first-in-human study to demonstrate the safety and effectiveness of the cardiofocus optishot pulsed field ablation system for catheter ablation of atrial fibrillation (af). patients with symptomatic paroxysmal (short-duration) af who have not had a previous catheter ablation for af will be considered for the study. patients will be followed for one year after the initial ablation procedure.

this is a prospective, single-arm first-in-human study to demonstrate the safety and effectiveness of the cardiofocus optishot pulsed field ablation system for catheter ablation of atrial fibrillation (af). patients with symptomatic paroxysmal af who are undergoing first-time pulmonary vein isolation will be considered for the study. patients will be followed for one year after the initial ablation procedure.

Eligibility criteria:
inclusion criteria: * recurrent symptomatic paf with at least one documented episode * failure or intolerance of at least one aad * age 18-75 years * patient is indicated for an ablation procedure according to society guidelines or study site practice * patient is willing and able to give informed consent/participate in baseline and follow-up assessments for the duration of the study exclusion criteria: * overall good health as established by multiple criteria

Keywords: ablation pulsed field ablation
comparison of two strategies for the management of atrial fibrillation after cardiac surgery

Conditions: Atrial Fibrillation; Cardiac Surgery

Summary: postoperative atrial fibrillation is a common complication after cardiac surgery with a rate of 30%. however, management of postoperative atrial fibrillation is controversial. two strategies are recommended : heart rate control using a betablocker or rhythm control with amiodarone. landiolol is a new-generation beta-blocker with a short half-life, which was approved by the haute autorité de santé to be used in perioperative supra-ventricular tachycardias. only one study compared landiolol to amiodarone in the perioperative setting, with a better hemodynamic tolerance and a higher rate of conversion to sinus rhythm with landiolol. however this was a single-center and retrospective study. the aim of our multicenter randomized study is to compare the effectiveness of landiolol in reducing atrial fibrillation to sinus rhythm compared to amiodarone in the postoperative period after cardiac surgery.

randomized clinical study comparing landiolol and amiodarone for treatment of atrial fibrillation following cardiac surgery

Eligibility criteria:
inclusion criteria: * adult patients hospitalized in the cardiac icu after having undergone cardiac surgery (cabg, aortic valve or ascending aortic root replacement or a combination of both) * new onset of atrial fibrillation lasting more than 30 minutes in the postoperative period after cardiac surgery * french speaking patients * written consent * patients with social security insurance exclusion criteria: * hemodynamic instability requiring electrical cardioversion of atrial fibrillation * sepsis * bradyarrythmia (\< 90/min) * patients requiring inotropes in the postoperative period * patient with pre-existing atrial fibrillation * patient with anticoagulant therapy before surgery * contraindication to amiodarone or beta-blockers * urgent surgery (\< 24h), ventricular assist device, heart transplant, tavr, mechanical valve, mitral or tricuspid valve replacement. * no written consent * pregnant women, * underaged patients (\<18 years old) * patients not able to give consent (curators, patients deprived of public rights)

Keywords: cardiac surgery atrial fibrillation