Kornimate/medical-research-clean huggingface dataset:
the effectiveness of an educational intervention based on self-help for sleep hygiene promotion on patients with insomnia

Conditions: Insomnia; Behavioral Intervention

Summary: this plan will be implemented on the staff of the qazvin university of medical sciences. the insomnia severity index questionnaire will be used to screen for insomnia and low sleep health. this questionnaire is provided online to the staff through communication channels such as telegrams to help people who are interested in participating in this research. individuals who scored more than 8 were randomly assigned to intervention and control groups and completed the insomnia index index. the intervention group will then receive an app-based educational intervention designed to improve sleep hygiene. control group: participants in the control group perform routine activities. the intervention and control group will fill out the relevant questionnaire one and three and six months after the completion of the training to assess the impact of the intervention online.


Eligibility criteria:
inclusion criteria: * clinical level of insomnia (more than 10 on isi) * meets criteria for insomnia according to dsm-iv-tr * enough language skills * have access to an android smartphone or a desktop computer with internet access * participants will be required to sign an informed consent form exclusion criteria: * uncontrolled medical condition suspected to interfere with sleep or requiring immediate treatment outside of the study * alcohol/drugs abuse * participation in other trials concurrently * pregnancy * having children under 2 years old * not having an internet-connected computer, cellular phone or tablet * working night shifts * somatic or psychiatric conditions requiring acute care
pyl in patients with high risk and biochemically recurrent prostate cancer

Conditions: Prostate Cancer

Summary: the standard of care imaging of prostate cancer metastases recommended by the national comprehensive cancer network (nccn), ct of the chest/abdomen/pelvis and bone scan, may be suboptimal. pyl is a novel pet tracer designed to detect prostate specific membrane antigen (psma) expressed on prostate cancer cells. pyl pet/ct may provide improved evaluation of clinically significant metastases in patients with prostate cancer.

this will be a phase ii clinical trial to assess the clinical value of pyl for detection of disease in pateints with: 1. high risk prostate cancer and planned prostatectomy or radiation therapy (arm 1) and 2. biochemically recurrent prostate cancer (arm 2) but without evidence of disease of standard of care imaging (ct of the chest/abdomen/pelvis and bone scan). in both cohorts, pyl pet/ct will be obtained and evaluated by a nuclear radiologist trained in novel pet radiotracers, including pyl. lesions suspicious for disease of pyl that were unsuspected on standard of care imaging will be selected for biopsy for pathologic confirmation if feasible . pathology will be used as the reference standard for confirming malignancy.

Eligibility criteria:
inclusion criteria: 1. male ≥ 18 years of age. 2. histologically confirmed adenocarcinoma of the prostate 3. patients meet one of the follow criteria: cohort 1: high risk prostate cancer (psa \>10, gleason 8-10, or clinical stage \>t2c) and planned prostatectomy or radiation therapy or cohort 2: biochemical prostate cancer relapse (prostate specific antigen (psa) \> 0.2 ng/ml in patients following prostatectomy or ≥ 2 ng/ml more than the psa nadir in patient following radiotherapy, as defined by the astro-phoenix criteria \[18\] and no evidence of malignancy on standard of care imaging for metastases (ct of the chest/abdomen/pelvis and bone scan) within 3 months. exclusion criteria: 1. presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data. 2. patients who cannot undergo pet/ct scanning because of weight limits. pet/ct scanners may not be able to function with patients over 450 pounds. 3. change in therapy since standard of care imaging

Keywords: prostate cancer dcfpyl pet/ct staging biochemical relapse
effects gluten intake on body composition, energy expenditure and adipokine profile in non-celiac women with obesity

Conditions: Obesity

Summary: this is a double-masked, crossover, randomized, controlled study that aims to evaluate, in women with obesity, a possible influence of wheat gluten on food choices, body weight, resting metabolism and circulating inflammation markers and adipokines. the volunteers will be randomized into two groups, half of them will initiate the experiment by taking 2 placebo muffins daily for 4 weeks (placebo phase) and the remnant volunteers will take 2 corn muffins containing 12g of gluten/each for 4 weeks (gluten phase). at the 1st, 4th and 8th experimental weeks will be evaluated body weight, body composition, lipid profile, glucose, insulin, leptin, adiponectin, and inflammatory markers.

it is a double-masked, crossover, randomized, controlled study. for this, volunteers will be kept on gluten-free diet for 8 weeks. at the first moment, a structured food frequency questionnaire will be applied, as well as a 72-hour food register, to evaluate routine of food consumption and daily intake of gluten. the volunteers will be randomized into two groups, half of them will initiate the experiment by taking 2 placebo muffins daily for 4 weeks (placebo phase) and the remnant volunteers will take 2 corn muffins containing 12g of gluten/each for 4 weeks (gluten phase). after that, volunteers will be transferred for the other phase for 4 more weeks. during the 8 experimental weeks, all volunteers will be instructed to exclude any food containing gluten from their diet. at the 1st, 4th and 8th experimental weeks after 12 hours of fasting and 30 minutes of resting, volunteers will be submitted to indirect calorimetry, electrical bioimpedance, blood collection and anthropometry (weight and height). the volunteers will also respond a questionnaire about life habits, family history, previous history, physical activity and food frequency. blood samples will be used to assess blood count, lipid profile, glucose, insulin, leptin, adiponectin, and inflammatory markers (soluble vcam, c-reactive protein, fibrinogen). four weeks after the end of the experiment, and return to the alimentary routine, body weight, blood sample, calorimetry and bioimpedance will be reassessed.

Eligibility criteria:
inclusion criteria: * women between 20 and 50 years without diagnosis of celiac disease * overweight and obese, respectively, bmi of 24.9- 34.9 * without menopause exclusion criteria: - subjects with positive serology for celiac disease or allergy to wheat

Keywords: gluten adipokine obesity diet
radiant: cd101 vs standard of care in subjects with acute vaginal yeast infections

Conditions: Candidiasis, Vulvovaginal; Mycoses; Yeast Infection; Moniliasis, Vulvovaginal; Vaginitis, Monilial

Summary: the purpose of this study is to determine if two topical formulations of cd101 are safe and effective in the treatment of acute moderate to severe vulvovaginal candidiasis (vvc) compared to oral fluconazole.

this is a phase 2, multicenter, randomized, open-label, sponsor-blind, active-controlled, dose-ranging trial of female subjects with an acute moderate to severe episode of vulvovaginal candidiasis. subjects will be randomized to 1 of 3 treatment arms; cd101 gel, cd101 ointment, or oral fluconazole. after randomization, subjects will be seen on day 7 (+/-2 days), day 14 (+/- 2 days), \& day 28 (+/-7 days) to assess therapeutic cure and safety.

Eligibility criteria:
inclusion criteria: * moderate to severe acute vulvovaginal candidiasis (severity score \>7) * positive potassium hydroxide wet preparation for pseudohyphae or budding yeast or positive becton dickinson affirm test or positive vaginal culture for candida species * vaginal ph \<4.5 for subjects with positive potassium hydroxide wet preparation * able to give written informed consent exclusion criteria: * receipt of intravaginal or systemic antifungal therapy within 7 days of randomization * known or suspected infectious causes of vulvovaginitis other than candidiasis * history of genital herpes * planned treatment or surgery during the study period for cervical intraepithelial neoplasia or cervical carcinoma * need for non-protocol systemic or vaginal antifungal therapy * history of hypersensitivity or allergic reaction to echinocandins, azoles, or their excipients * pregnant females * females who are breast feeding * women intending to become pregnant during the study period * recent use of an investigational medicinal product within 28 days or presence of an investigational device at the time of screening * subjects who use or anticipate use of intravaginal products * have any condition that the investigator believes would put the subject at risk for participation or would confound the results of the study
feasibility and safety of "flash glucose monitoring-fgm" in an adult italian population.

Conditions: Diabetes Mellitus, Type 1

Summary: diabetes is reaching epidemic proportions and a targeted glucose control is key to prevent microvascular complications as well as long-term macrovascular disease. self-monitoring of blood glucose (smbg) in type 1 diabetes (t1d) is mandatory to implement safe and effective adjustments in insulin therapy in order to reduce glucose levels and prevent hypoglycemic episodes. it is known that a higher rate of glucose testing (up to 8 times/day) is associated with improved glucose control, however, long-term repeated daily glucose tests are painful, inconvenient and difficult to pursue. continuous glucose monitoring (cgm) is an alternative to smbg, but the use of conventional cgm has been limited by the need of repeated calibration using capillary glucose testing, relatively short sensor lifespan and high costs. the recently introduced cgm freestyle libre™ (abbott diabetes care, witney, uk) flash glucose monitoring (fgm), a new generation of glucose testing device, has the advantage to be user friendly by just scanning the reader over the sensor. the fgm system does not require calibration, has a long sensor lifetime of 14 days and it's relatively affordable, explaining the widespread use of the device. the flash glucose monitoring-fgm is a real-time glycemic monitoring system called "hybrid" as it is not equipped with alarms capable of alerting the patient to cut-off value for the hypo- or hyperglycemia, but allows the glycemic trend to be viewed at request.

patients will be identified and enrolled in the diabetes departments of different hospitals/clinics in the emilia romagna region, italy. patients will be divided in two groups a (naive patients,) and b (patients already using the device at enrollment) and followed for 12 months. study design is observational prospective and includes 3-months follow up visits until the 12-month final evaluation. at each visit, patient clinical data, adherence and side effects will be recorded and data download from the device will be performed.

Eligibility criteria:
inclusion criteria: * diagnosis of diabetes mellitus type 1 for at least 12 months * multi-injection insulin therapy * c-peptide \<0.2 nmol/l * at least 1 documented episode in the last 12 months of hospitalization (emergency room or ordinary hospitalization) for severe hypoglycemia; hospitalization (emergency room. or ordinary hospitalization) for diabetic ketoacidosis; documented severe hypoglycemia (i.e. with blood glucose measurement). exclusion criteria: * diabetes mellitus type 2 * other types of diabetes * other diseases (excluding endocrinopathies, hypertension and dyslipidemia) that required chronic intake of drugs that may interfere with the glucose-insulin system.

Keywords: flash glucose monitoring glucose monitoring diabetes mellitus type 1
efficacy and safety of treatment with balaglitazone in type 2 diabetes patients on stable insulin therapy

Conditions: Diabetes Mellitus, Type 2

Summary: type 2 diabetes mellitus is a metabolic disorder that is primarily characterized by insulin resistance, relative insulin deficiency, and hyperglycemia. people with type 2 diabetes are at high risk of many serious diabetic complications, including cardiovascular disease, blindness, nerve damage and kidney damage. balaglitazone is a thiazolidinedione derivative that is being developed as an oral anti-diabetic drug to improve blood glucose control in patients with type 2 diabetes. the purpose of this study is to assess if additional treatment with balaglitazone in patients with type 2 diabetes on stable insulin treatment will improve blood glucose control and decrease the daily insulin dose compared to placebo, but with less impact on weight gain and oedema than pioglitazone (actos®) 45 mg.


Eligibility criteria:
inclusion criteria: 1. type 2 diabetes mellitus, being diagnosed according to the 1999 who criteria for at least 3 months 2. age ≥ 18 years 3. bmi ≥ 25.0 kg/m2 4. hba1c ≥ 7.0 % 5. treatment with insulin with stable dose of at least 30 u/day (± 4 u/day), for at least 75 days exclusion criteria: 1. prior or current use of any ppar-γ agonist 2. recent use (\< 3 months) of an investigational drug 3. pre-existing medical condition judged to preclude safe participation in the study 4. contraindication/intolerance to study medication 5. use of any drug which in the investigator's opinion could interfere with the glucose level (e.g. systemic corticosteroids) 6. diagnosed or receiving medication for heart failure, nyha i to iv 7. hospitalisation for a major cv event in the last 3 months, scheduled major cv intervention 8. uncontrolled treated/untreated systolic blood pressure \>180 mmhg and/or diastolic blood pressure \> 95 mmhg 9. known diabetic macular oedema 10. hematuria 11. serum creatinine \>130 μmol/l 12. alt, ast, total bilirubin or alkaline phosphatase ≥ 2.5 times the upper limit of normal 13. haemoglobin significantly (in the investigators opinion, but not more than 1 mmol/l) below the lower limit of normal or haemoglobinopathy interfering with valid hba1c assay 14. pregnancy, breast feeding or planning pregnancy or not using adequate contraceptive methods (adequate contraceptive measures are an intrauterine device or oral contraceptives) 15. mental incapacity, unwillingness, or language barrier precluding adequate understanding or cooperation 16. abuse of alcohol or drugs, or presence of any condition that in the investigators opinion may lead to poor adherence to study protocols 17. cancer or any clinically significant disease or disorder, except for conditions associated to the type 2 diabetes, which in the investigator's opinion could interfere with the results of the trial

Keywords: type 2 diabetes mellitus on stable insulin therapy balaglitazone pioglitazone (actos®) hba1c weight gain oedema fasting blood glucose
"a multicenter study comparing the clinical outcomes of the nuss and ravitch procedures for repair of pediatric pectus excavatum

Conditions: Repair of Pectus Excavatum

Summary: the main goal of the pectus multicenter outcomes study is to document the utility of pex repair in improving health and quality of life and to test the prevailing belief that the two predominant surgical procedures currently in use for pex repair are essentially equivalent in terms of long-term outcomes. we believe the uncertainty about the impact of pex on cardiopulmonary function is due to part to the fact that the previous studies have not measured the physiological parameters mostly likely affected by the defect. a protocol to test this was developed. thus, we propose to use these measures as well as conventional output of progressive exercise test to examine cardiopulmonary function before and after surgical repair of pex within the context of the original study.


Eligibility criteria:
inclusion criteria:haller index by thoracic computed tomography (ct) scan of 3.2 or greater, has decided to have surgery to repair pex, written informed consent obtained from the parent or guardian of the subject,or, fro subjects 18-21 years, from the subject him(her)self, and assent of the child. - exclusion criteria:pectus carinatum, poland's syndrome or other comlex chest wall anomaly,previous repair of pex by any technique, previous thoracic surgery, congenital heart disease, bleeding dyscrasia, history of major anesthetic risk factors such as malignant hyperthermia, pregnancy, surgical repair to be performed with bar other than stainless steel. -
a comparison of pharmacodynamics and pharmacokinetics of insulin aspart, biasp70, biasp50 and fast-acting human insulin

Conditions: Diabetes Mellitus, Type 1

Summary: the hypothesis is that an optimal formulation of fast acting and intermediary acting insulin analogues will improve post prandial glycaemic control in patients with type 1 diabetes

this trial is a single centre, open-label, randomised 4 period cross-over trial, comparing the pk and pd profiles of iasp, biasp 50, biasp 70 and fast-acting human insulin after a standard test meal in subjects with type 1 diabetes. the profiles will be derived over a 12-hour period after subcutaneous injection in the abdominal region with a single dose of iasp, biasp 50, biasp 70 or fast-acting human insulin at a test meal. the trial consists of a screening period of 4-21 days and 4 treatment visits.

Eligibility criteria:
inclusion criteria: * informed consent obtained before any trial-related activities. * diagnosed type 1 diabetes before the age of 40 and on insulin treatment within one year of diagnosis. * insulin treatment of any regime for more than one year at time of inclusion. * total insulin demand ≥ 0,4 u/iu/kg/24 hrs * hba1c between 7% and 12% (both values included). * age ≥ 18 years. * bmi between 18 and 35 kg /m2 (including both values). exclusion criteria: * known or suspected allergy to trial product(s) or related products. * recurrent major hypoglycaemic episodes. * heart: unstable angina pectoris, ami \< 12 months or heart insufficiency classified according to nyha iii-iv * blood pressure: severe uncontrolled hypertension with bp \> 180/110 mmhg, sitting * liver: impaired hepatic function corresponding to serum-alat or basic phosphatase \> 2 x upper reference limit of the local laboratory. * kidneys: impaired renal function corresponding to serum-creatinin \> 150 μmol/l according to the local laboratory. * any disease judged by the investigator to affect the trial. * pregnancy, breast-feeding or the intention of becoming pregnant or fertile women not using adequate contraceptive measures - adequate contraceptive method is sterilisation, hysterectomy or current use of contraceptive pills or intra uterine device.

Keywords: diabetes
evaluation of the clinical and cost-effectiveness of an automated mobile hybrid room in vascular surgery compared with current practice

Conditions: Endovascular

Summary: evaluation of the clinical and cost-effectiveness of a mobile hybrid room compared with current practice without mobile hybrid room and imaging fusion guidance, in a french multicentre clinical setting. the hypothesis is that the use of a mobile hybrid room with an automated artificial intelligent image fusion system would directly benefit patients, health worker and health care system by reducing procedure time, patient and staff exposure to radiation, improve clinical success and reduce costs (requested by a fixed imaging system installation and increasing the number of patients). this will also improve the safety of these procedures for patient and staff, when a conventional hybrid room is not available

multi-centre, patient- and observer-blinded, two-armed, parallel groups randomised controlled trial. 7 french university hospital will include 350 patients presenting with aaa or aorto iliac occlusive disease suitable for endovascular treatment, to either repair using standard x-ray fluoroscopy imaging alone (the current reference standard) or augmented with automated image fusion. the study will be conducted in real-world clinical settings and will focus on multiple providers to demonstrate the effect in the wider healthcare system. the trial will be conducted in 7 centres in france over 24 months. 350 patients will be recruited over a 18 month period, with 3 months minimum follow-up. every vascular surgeon will be trained to use properly the fusion system, and the first 5 patients of each center won't be included. radiation parameters (machine report, passive dosimeters), iodinated contrast, technical and clinical success at 30-d and 3 months, procedure time, fluoro time, and costs will be collected.

Eligibility criteria:
inclusion criteria: * procedure carried out in an operating theatre equipped with a mobile operating theatre c-arm or a mobile planar or an old-generation fixed room with no image fusion available * surgeon trained in the use of image fusion * operator who has given their consent * endovascular management of an aorto-iliac artery disease or a sub-renal aaa using a sub-renal bifurcated stent graft * patient in possession of an angioscan less than 6 months old * patient of legal age who has given his/her consent * ionising radiation generator with up-to-date and validated quality control * participant affiliated to a social security scheme exclusion criteria: * first procedure with fusion for the previously trained surgeon. * procedure performed without an operating aid. * emergency procedure. * associated surgical procedure (femoropopliteal lesions, lesions of the renal or digestive arteries, iliac branch). digestive arteries, iliac branch). * patients with aaa that cannot be treated by a simple sub-renal endovascular approach simple endovascular approach (subrenal bifurcated stent graft) * aortic emergencies (ruptured aaa). * persons under guardianship, curatorship or safeguard of justice * pregnant or breast-feeding women.
the efficacy of distortion banding on outcome measures in children with cerebral palsy

Conditions: Cerebral Palsy, Spastic

Summary: the aim of the study is to compare the conventional rehabilitation program and the distortion taping applied with kinesio tex tape in addition to conventional rehabilitation in children with hemiplegic or monoplegic cerebral palsy with ankle varus deformity.

conventional rehabilitation practices will be applied to the control group. in addition to kinesio tex tape distortion taping, conventional rehabilitation will be applied to the intervention group. it is aimed to evaluate the patients' balance, quality of life, performance test, spasticity level and gait quality.

Eligibility criteria:
inclusion criteria: * children with cerebral palsy aged 4-12 years with unilateral involvement who are hemiplegic or monoplegic * cases with gross motor function classification (gmfcs) level 1 or 2 * understanding simple commands and signing the consent form exclusion criteria: * presence of equinus deformity * situations that may prevent assessments or communication * lack of cooperation during work * presence of surgery that may affect assessments, such as joint freezing * presence of botulinum toxin administration in the last 6 months * development of an allergic reaction on the skin to the tape

Keywords: cerebral palsy kinesio taping