Kornimate/medical-research-clean huggingface dataset:
investigation of the effect of sexuality-based family planning education given to women via podcast on contraceptive method selection and sexual life quality

Conditions: Contraception

Summary: in this study, it was aimed to examine the effect of sexuality-based family planning education given to women of childbearing age via podcast on contraceptive method selection and sexual life quality. accordingly, the hypotheses of the study are as follows: hypotheses of the project h1: sexuality-based family planning education via podcast has an effect on women's conscious and appropriate contraceptive method selection. h2: sexuality-based family planning education via podcast has a positive effect on women's sexual life quality. h3: sexuality-based family planning education via podcast has a positive effect on the quality of sexual life of women by increasing their level of contraceptive knowledge. h4: sexuality-based family planning education via podcast has a positive effect on women's attitudes towards family planning.

the aim of this study was to examine the effect of sexuality-based family planning education given to women of childbearing age via podcast on contraceptive method selection and sexual life quality. the study is planned to be conducted as a randomized controlled experimental study and women of childbearing age within the borders of istanbul will be included in the study. the research will be conducted between november 2023 and may 2024 and a total of 176 women will be included in the study. the included women will be divided into two groups as experimental and control groups. data will be collected by applying the personal information form, contraceptive knowledge rating scale-turkish form (ckra-tr), sexual quality of life scale-woman (sqls-w) and family planning attitude scale (fpas). women in the experimental group will be given sexuality-based family planning education consisting of 5 modules via podcasts. in addition, a brochure on family planning and education will be shared with the women in the experimental and control groups. the data obtained in the research will be entered into the database in ibm spss 29.0 (statistical package for the social sciences) program and all necessary statistical analyzes will be performed in the same program.

Eligibility criteria:
inclusion criteria: * volunteer to participate in the study, * 15-49 years old, * does not have any physical or mental disability, * at least primary school education, * at least one sexual partner, * sexually active women will be included in the study. exclusion criteria: * not sexually active in the last 4 weeks, * trained in the use of contraceptive methods, * being treated for any sexual dysfunction, * women with any psychiatric illness will be excluded from the study.

Keywords: family planning contraceptive sexuality
valvular microbiota and valvulopathy

Conditions: Valvulopathy

Summary: few teams in the world can reliably analyze tissue microbiota. in this regard, the present group has unique expertise in the analysis of blood and tissue microbiota, the first to describe in 2011. having a blood biomarker of this valve microbiota could help guide the therapeutic strategy before and after the intervention. this study will be the first to test the hypothesis that the analysis of the blood microbiota makes it possible to detect the carriage of a tissue microbiota in patients undergoing aortic valve replacement (avr) for degenerative aortic valve disease and should also lay the foundations for a prospective study. intended to evaluate the impact of the blood and valve microbiota on the post-operative prognosis of these patients and the complications at one year. this would be a first proof of concept of the role of the tissue microbiota in valvular degeneration linked to aging.


Eligibility criteria:
inclusion criteria: * indication for surgical avr: * tight ra: * symptomatic (dyspnea, syncope/lipothymia, angina); * and/or echocardiographic criterion: * valve surface \< 1cm2 (and/or 0.6cm2/m2); * average transvalvular gradient \> 40mmhg; * aortic jet velocity (vmax) \> 4.0m/s; * or low transvalvular gradient (mean gradient \< 40mmhg) + left ventricular ejection fraction (lvef) \< 50% but contractile reserve; * and/or high calcium score on ct angiography; * asymptomatic tight ra and: * lvef \< 50% without other cause; * and/or symptoms during exercise; * and/or low surgical risk + severity criteria: vmax \> 5.5m/s (or progression \> 0.3m/s/year), nt-probnp level \> 3xnormal, severe pulmonary arterial hypertension (pulmonary systolic pressure \> 60mmhg); * moderate ar + concomitant surgical indication for another heart disease; * severe ai: regurgitant orifice \> 30mm2, regurgitated volume \> 60ml/beat, * symptomatic (dyspnea, syncope/lipothymia, angina); * and/or left ventricular dysfunction: lvef \ 70mm, end-systolic diameter \> 50mm (or \> 25mm/m2); * and/or concomitant surgical indication for another heart disease.

Keywords: microbiota
interaction between body posture and nocturnal sleeping disorders in dysgnathic patients

Conditions: Dentofacial Deformities; Sleep Disorder; Posture

Summary: the role of head posture has been demonstrated in patient with dentofacial deformities. however, the relationship between body posture and jaw disorders is unclear. moreover, patients with obstructive sleep apnea have the same anatomical abnormalities than patients with dentofacial deformities. the aim of this study is to evaluate, firstly, nocturnal sleeping disorders among patients with jaw disorders. secondly, the investigators aim to evaluate the interaction between body posture, breathing and dentofacial deformities. a polygraphy will be performed on patient with dentofacial deformities before and after correcting jaw surgery. a postural evaluation will be done using eos imaging system and a force plate


Eligibility criteria:
inclusion criteria: * patient in orthodontic preparation for a surgical treatment, * age \> 16 years exclusion criteria: * postural disorder (scoliosis, history of spine surgery), * pregnancy or breastfeeding, * patients under guardianship
evaluation of toxic metals, trace elements and total antioxidant activity in children with recurrent wheezing

Conditions: Asthma; Wheezing

Summary: the purpose of this study is to evaluate hair trace elements and toxic metals and plasma total antioxidant activity in children with recurrent wheezing and to evaluate whether these toxic metals and trace elements have any impact on serum cytokine levels.

context: in many studies it was demonstrated that children are much more susceptible than adults for environmental toxic metal exposure. hair analysis is a promising tool for routine clinical screening and diagnosis of heavy metal exposure and essential trace element states in the human body. additionally it was demonstrated that oxidants and antioxidants play a central role in the pathogenesis of many pulmonary diseases including asthma. furthermore, toxic metals, trace elements and oxidative stress have many pivotal role on immune system. objective: to evaluate and compare hair toxic metals, hair essential trace elements levels and plasma total antioxidant activity between children with recurrent wheezing and age and sex matched healthy children. intervention: hair samples will be collected for the analysis of the toxic metals, trace elements. blood samples will be collected for the analysis of the cytokine levels and plasma antioxidant activity. study measures: differences in hair toxic metals, hair trace elements, plasma cytokine levels and plasma total antioxidant activity will be compared between children with recurrent wheezing and age-sex matched healthy children

Eligibility criteria:
inclusion criteria: * children with recurrent wheezing ages between 6 months to 6 years old. * age and sex matched healthy children for control group. * parental/guardian permission (informed consent) exclusion criteria: * systemic corticosteroid use in the last 30 days * chronic lung diseases including cystic fibrosis * immunodeficiency * known renal or hepatic dysfunction * respiratory truck infections in the last 30 days * anatomic abnormalities of the respiratory tract * suspected foreign body aspiration or croup * immunosuppressive or immunostimulant treatment

Keywords: wheezing hair trace elements hair toxic metals oxidative stress
the effect of asthma flare-up clinic after exacerbation

Conditions: Asthma; Asthma Attack

Summary: the goal of this interventional study is to examine the effect of asthma flare-up clinic follow-up in adult subjects after an asthma flare-up. this study aim to answer the following questions: 1. does a follow-up in a flare-up clinic improves disease outcomes? 2. does a follow-up in a flare-up clinic improves disease management? participants in the intervention group will take part in a structured follow-up at the asthma flare-up clinic at three time points. each visit will include questionnaires, pulmonologist examination and consultation, laboratory tests and spirometry. the control group will undergo phone-call follow-up with a research coordinator in similar time frames as the intervention. researchers will compare the two groups to see if the clinic follow-up affects the study outcomes.

the primary outcomes will be analyzed as total exacerbations during the time frame and as a time-dependent variable (time to exacerbation) using kaplan meier survival analysis. additional sub-analyses will be made for the type of inclusion setting (ed/hospitalization), number of prior exacerbations, and eosinophil count. additional analyses will be made for all secondary outcomes. analyses relevant only for the intervention group (such as spirometry and ios) will compare results to the first follow-up visit. a cost-effectiveness analysis will be made, comparing the follow-up cost and the cost saved by exacerbation reduction based on the final results. sample size calculation - the invetigators assume based on previous research that the intervention will lead to a 20% decrease in exacerbations during the 12 months from first follow-up. to achieve an alpha of 0.05 and a power of 80%, there is a need for 88 patients in each group. assuming a loss-to-follow-up rate (missing to complete at least 2 clinic visits or loss to phone follow-up) of 20%, the study will need 115 patients in each group (230 overall).

Eligibility criteria:
inclusion criteria: * prior asthma diagnosis based on clinical and spirometry accepted criteria. * acute exacerbation of asthma as the main reason for ed arrival. * ability to perform in-person and telephone follow-up. * agree to participate, with a signed or verbal informed consent, according to the study group. exclusion criteria: * uncontrolled comorbidity. * cognitive dysfunction. * patients under 18 years or above 75 years. * chronic obstructive pulmonary disease (copd) or other lung diseases (eg, idiopathic pulmonary fibrosis, churg-strauss syndrome, etc) which may impair lung function.

Keywords: asthma flare-up asthma management clinic pulmonologist
safety study of mesenchymal precursor cells in type 2 diabetes

Conditions: Type 2 Diabetes

Summary: this study is being conducted to assess the overall safety and tolerability of a single intravenous infusion of three doses of mesenchymal precursor cells versus placebo in subjects with type 2 diabetes inadequately controlled on metformin.


Eligibility criteria:
key inclusion criteria: * male and female subjects who are ≥ 18 and ≤ 80 years old * subjects diagnosed with type 2 diabetes at least one year prior to screening and receiving a stable, therapeutic dose of metformin \> 1500 mg/day according to local prescribing information for at least 3 months prior to screening or the highest tolerated dose \> 1000 mg/day documented in the subject's history * hba1c \> 7.0% and \< 10.5% at screening * c-peptide \> 0.8 ng/ml at screening * body mass index (bmi) \> 22 and \< 45 kg/m2 at screening * body weight \< 150 kg at screening key exclusion criteria: * prior participation in any stem cell study * women who are pregnant, intending to become pregnant during the study period or currently lactating * history of active substance abuse (including alcohol) within the past 2 years. current alcohol abuse is defined as daily consumption of \>3 alcoholic beverage. current cigarette smoking \> 10 cigarettes per day * severe hypoglycemia (defined as requiring third party assistance) or repeated and/or frequent hypoglycemia episodes (\> 2 episodes/week) within one month prior to screening * patients receiving treatment for type 2 diabetes with diet and exercise alone, insulin therapy within 6 months of screening except if used transiently for \< 7 days for intercurrent illness or any other anti-diabetic medication except metformin within 3 months of screening * any concurrent medical condition/disorder or clinically symptomatic cardiovascular, gastrointestinal (including pancreatitis), renal, hematological, pulmonary, acute or chronic infectious disease, active retinal disease, or other disorder which in the investigator's opinion would interfere with the subject's ability to complete the trial, would require administration of treatment that could affect the interpretation of the safety and efficacy variables or would preclude safe involvement in the study.
contrast-enhanced mri for the characterization of ductal carcinoma in situ (dcis)

Conditions: Breast Cancer

Summary: \*referrals to this trial must be through breast care clinicians only\* rationale: diagnostic procedures, such as contrast-enhanced mri, may help find and diagnose ductal carcinoma in situ. purpose: this study is to develop and refine magnetic resonance (mr) imaging methods for pre-operative staging of ductal carcinoma in situ, a pre-invasive form of breast cancer, and atypical ductal hyperplasia, a risk factor for developing cancer.

objectives: * compare the dcis optimized mri to the standard clinical mri. using a scale of 1-5 from poor to excellent, images will be assessed for conspicuity of dcis and atypical ductal hyperplasia (adh) lesions, agreement of disease extent with biopsy, and overall image quality (artifact level, uniformity of fat suppression, contrast to noise ratio and signal to noise ratio). * subjects with adh, a benign condition that can also show enhancement on mri, will be enrolled to explore the utility of the dcis optimized mri for distinguishing dcis and adh.

Eligibility criteria:
disease characteristics: * meets 1 of the following criteria: * patients at the university of california, san francisco breast care center meeting the following criteria: * biopsy proven ductal carcinoma in situ (dcis) of the breast. * has undergone mammography within the past 60 days. * adh patients: over 18, no prior history of breast disease. patient characteristics: * referrals to this trial are through breast care clinicians only * not pregnant or nursing (or stopped nursing within the past 3 months) * negative pregnancy test * no contraindication to mri (e.g., implanted pacemaker, implanted ferromagnetic device, ferromagnetic aneurysm clip, severe claustrophobia, ocular metal fragments, or shrapnel injury) prior concurrent therapy: * more than 2 years since prior surgery to the ipsilateral breast (patient) * no prior radiotherapy to the ipsilateral breast (patient) * no prior cytotoxic regimens (patient)

Keywords: ductal breast carcinoma in situ
a study of alks 3831 in adults with schizophrenia (the enlighten-2 study)

Conditions: Schizophrenia

Summary: this study will evaluate weight gain of alks 3831 compared to olanzapine in adult subjects with schizophrenia.


Eligibility criteria:
inclusion criteria: * subject has a body mass index (bmi) of 18.0-30.0 kg/m\^2, inclusive, at visit 1 and visit 2 * subject meets the dsm-5 criteria for a primary diagnosis of schizophrenia * subject is appropriate for outpatient treatment; has no hospitalizations for acute exacerbations of schizophrenia within 6 months before visit 1 * subject has maintained a stable body weight (change \</= 5%) for at least 3 months prior to visit 1 based on self-report * additional criteria may apply exclusion criteria: * subject has any of the following psychiatric conditions per dsm-5 criteria: * diagnosis of schizoaffective disorder or bipolar i or ii disorder, or current, untreated or unstable major depressive disorder * clinically significant cognitive difficulties present within the past 2 years that could interfere with participation in the study * drug-induced or toxic psychosis * any other psychiatric condition that could interfere with participation in the study * subject poses a current suicide risk at visit 1 or visit 2 in the opinion of the investigator * subject has inflammatory bowel disease or any other gastrointestinal disorder associated with weight loss, anorexia nervosa, or binge eating disorder * additional criteria may apply

Keywords: alkermes alks 3831 samidorphan schizophrenia olanzapine weight
cannabidiol for bilateral total knee arthroplasty

Conditions: Pain, Postoperative; Opioid Use; Knee Osteoarthritis

Summary: in light of the opioid epidemic and evidence suggesting that cannabis may be opioid-sparing, we are in a unique position to conduct a novel, high-impact study that would set the stage for future rcts examining the effects of a nonintoxicating and nonaddictive cannabinoid in an orthopedic patient population. epidiolex®, an oral cannabidiol (cbd) solution, is the first ever cannabis-derived medication to be approved by the food \& drug administration. our aim is to conduct a pilot study using a placebo oral solution, 400mg and 800mg epidiolex® to gather data on its effects on patients undergoing bilateral total knee arthroplasty (btka). we will be estimating whether epidiolex® is associated with minimal opioid use and adequate analgesia. we will also assess its tolerability, pharmacokinetics, and effects on inflammatory markers in the perioperative setting.


Eligibility criteria:
inclusion criteria: * age 18 to 75 * scheduled for same-day bilateral total knee replacements with participating surgeons * american society of anesthesiologists (asa) physical status 1 or 2 exclusion criteria: * asa 3 and higher * weight \< 40kg * planned use of general anesthesia * contraindication to major components of study protocol * cannabis or cannabinoid use within the past 3 months (recreational and/or medical) * use or ingestion of hemp seeds or hemp oil in any form within the past 30 days * chronic opioid use (\>3 months) * coumadin use * current use of ssri or snris * history of substance abuse or dependence * active or history of major psychiatric illness * severe cardiovascular disorder * severe hepatic or renal insufficiency (transaminase levels above uln) * history of epilepsy * diagnosis of rheumatic disease, autoimmune disease, or immunodeficiency (e.g. rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease, multiple sclerosis, etc.) * use of valproate or clobazam * known or suspected hypersensitivity, allergy, or contraindication to cannabinoids or any of the excipients in the study medications (i.e. sesame oil, sucralose, strawberry flavor) * active use of steroids - oral steroids upon admission * stress dose steroids * non-english speakers * planned discharge to home without caregiver(s)
human papillomavirus (hpv) type distribution in adult women diagnosed with invasive cervical cancer in new zealand

Conditions: Cervical Cancer

Summary: the aim of this study is to assess the distribution of the most frequent types of human papillomavirus in women diagnosed with invasive cervical cancer in new zealand.


Eligibility criteria:
inclusion criteria: * a female aged 18 years and above at the time of cervical specimen collection, and currently residing in new zealand. * histological diagnoses of invasive cervical cancer stage ib or greater, within at least the last 3 years. * written informed consent obtained from the subject/ next of kin/ legally acceptable representative. * availability of cervical specimen on which the diagnosis was made prior to any chemotherapy or radiotherapy. * the cervical specimen should be of appropriate size and with regular tissue specimens. * the cervical specimen should be adequately preserved. * all links to the subject's identity should be removed from the paraffin block. exclusion criteria: not applicable.

Keywords: invasive cervical cancer human papillomavirus
abdominal functional electrical stimulation to reduce hyperinflation in chronic obstructive pulmonary disease patients

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: this is an early feasibility study to investigate whether transcutaneous electrical stimulation applied to the abdominal wall muscles synchronous with voluntary exhalation can be used to support ventilation and affect hyperinflation in patients with chronic obstructive pulmonary disease. as part of this study, the effect of a range of stimulation intensities and stimulation timing profiles will be explored.


Eligibility criteria:
inclusion criteria: * post-bronchodilator fev1/fvc ratio of less than 0.7 and post-bronchodilator fev1 between 30 and 80 % predicted. * current or former smokers with at least a 20 pack year smoking history * over the age of forty exclusion criteria: * female subjects who are pregnant * subjects unable to give informed consent * subjects unable to perform required activities of the study (e.g. six minute walk test) * subjects with an implanted electronic device (e.g. a cardiac pacemaker) * subjects who have had a chronic obstructive pulmonary disease exacerbation within 30 days prior to enrollment * considerable arthritic changes that limit exertion * patients on oral prednisone * patients with a hernia * patients with a history of pneumothorax within the last 5 years * history of epilepsy * history of abnormal electrocardiogram suggestive of cardiac disease

Keywords: chronic obstructive pulmonary disease lung hyperinflation abdominal muscle functional electrical stimulation
comparison of nn1250 plus insulin aspart with insulin glargine plus insulin aspart in type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in africa, europe and the united states of america (usa). the aim of the trial is to compare nn1250 (insulin degludec, soluble insulin basal analogue (siba)) plus insulin aspart with insulin glargine (iglar) plus insulin aspart in patients with type 1 diabetes. the main period is registered internally at novo nordisk as nn1250-3583 while the extension period is registered as nn1250-3644.


Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus for at least 12 months * current treatment with any basal bolus insulin for at least 12 months * hba1c below or equal to 10.0% * bmi (body mass index) below or equal to 35.0 kg/m\^2 * for the extension trial only: completion of the 52 week treatment period in trial nn1250-3583 (nct00982228) exclusion criteria: * use of any other antidiabetic drug than insulin within the last 3 months * cardiovascular disease within the last 6 months * uncontrolled treated/untreated severe hypertension * recurrent severe hypoglycemia or hypoglycemic unawareness or hospitalisation for diabetic ketoacidosis during the previous 6 months * pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements * cancer and medical history of cancer