Kornimate/medical-research-clean huggingface dataset:
a safety, pharmacokinetics and efficacy study of mau868 for the treatment of bk viremia in kidney transplant recipients

Conditions: BK Virus Infection

Summary: this clinical research study will test the safety and efficacy of the investigational medication mau868, compared to a placebo, in patients who have had a kidney transplant who have active bk virus.


Eligibility criteria:
inclusion criteria: * be a male or female 18 years of age or older. * recipient of a kidney (or kidney-pancreas) transplant within the year prior to enrollment * documented bkv viremia based on local or central laboratory testing within 10 days exclusion criteria: * a bkv plasma viral load which has exceeded 10\^3 copies/ml for \>4 months. * a bkv plasma viral load of ≥ 10\^7 copies/ml.
firmagon (degarelix) intermittent therapy

Conditions: Prostate Cancer Recurrent

Summary: men with localized prostate cancer requiring intermittent androgen deprivation therapy for biochemical recurrence following radical therapy will be asked to participate in a phase 4 safety and efficacy clinical trial comparing 10 months versus 4 months of degarelix (firmagon®) therapy with the endpoint of prolonging the off treatment interval.

this is an open-label, multi-centre, randomised trial with subjects receiving subcutaneous (s.c.) monthly injections of degarelix depot. all patients will be treated with a one-month starting dose of 240mg on day 0. subjects are then randomized to receive either nine or three maintenance doses of one month duration. the primary objective is to determine the effect of degarelix therapy on the length of the off treatment interval (defined as serum prostate-specific antigen (psa) increasing to 5 ng/ml) following completion of the androgen deprivation therapy. the trial will also assess the effect of degarelix therapy on psa kinetics (specifically psa doubling time), psa nadir, and effect on quality of life as well as other measures. the efficacy and safety of these two treatments will also be reported.

Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of the prostate for which intermittent endocrine treatment therapy is indicated * psa level meeting both of these criteria: * psa level of ≥ 5 ng/ml. * for patients with recurrence after radiotherapy or cryotherapy: patients should have a serum psa (two measurements) to be \>2 ng/ml higher than a previously confirmed psa nadir. * screening serum testosterone level above the lower limit of normal range defined as \>2.2 ng/ml. exclusion criteria: * has had previous or is currently under hormonal management of prostate cancer (surgical castration or other hormonal manipulation) * has received therapy with the 5-alpha reductase inhibitors finasteride or dutasteride within 12 weeks and 25 weeks, respectively, prior to screening

Keywords: localized prostate cancer degarelix intermittent androgen deprivation therapy
hybrid fractional laser treatment for symptoms of urinary incontinence

Conditions: Urinary Incontinence; Stress Urinary Incontinence; Urge Incontinence

Summary: this multi-center clinical trial will evaluate the safety and long-term efficacy of hybrid fractional 2940 nm and 1470 lasers for improvement of symptoms of urinary incontinence.

both 2940 nm er:yag (erbium-doped yttrium aluminium garnet) and 1470 nm diode lasers are cleared by the food and drug administration (fda) for ablation, vaporization, coagulation of soft tissue and for skin resurfacing. fractional delivery of laser is a well-established method that stimulates tissue remodeling in the dermis while leaving the surrounding tissue intact in order to decrease healing time. the layers of skin and vaginal mucosal tissue exhibit similarities that suggest the clinical results seen with skin resurfacing may be translated to the vaginal tissue. improved vaginal tissue tone and increased collagen formation in the lamina propria beneath the urethra may lead to improved urinary control. this multi-centered, 18-month prospective clinical trial will determine the safety and long-term effectiveness of hybrid fractional 2940 nm and 1470 nm lasers (hybrid fractional laser) as an alternative non-surgical, non-hormonal treatment for improvement of symptoms of urinary incontinence.

Eligibility criteria:
inclusion criteria: 1. healthy biological female aged between 30 to 75 years 2. is experiencing at least one or a combination of the following symptoms of urinary incontinence (ui) 1. involuntary urine leakage on effort, exertion, sneezing, coughing 2. sudden intense urge to urinate followed by involuntary loss of urine 3. has been experiencing symptoms of ui for greater than 3 months 4. normal urinalysis 5. has indicated willingness to participate in the study by signing an informed consent form 6. can read, understand and sign informed consent form 7. agree to adhere to the treatment and follow-up schedule and post treatment care instructions exclusion criteria: 1. undiagnosed abnormal genital bleeding 2. has history of pelvic surgery or other energy-based vaginal therapy within 6 months prior to enrollment 3. is pregnant or planning to get pregnant within the study period 4. is currently breastfeeding 5. has an active sexually transmitted infection (sti) 6. has equal to or greater than stage iii prolapse, according to pelvic organ prolapse quantification system (pop-q test) 7. has signs or symptoms of vaginitis/vulvitis 8. has signs or symptoms of acute urinary tract infection (uti) 9. has voiding dysfunction or urinary retention 10. has predominantly overactive bladder (oab) as proven by urodynamics 11. is currently taking medication for treating urinary incontinence 12. has a known history of neurologic disease 13. has history of heart failure 14. any medical conditions that might interfere with wound healing 15. has history of abnormal wound healing 16. has participated in any clinical trial involving an investigational drug or procedure within past 30 days 17. the investigator feels that for any reason the subject is not eligible to participate in the study.
a menopause interactive decision aid system

Conditions: Menopause

Summary: the purpose of this study is to develop and test a web-based system intended to help women going through menopause make more informed choices regarding menopause treatments. the system will do this by giving women personalized feedback on the risks and benefits of these treatments.

most women are not satisfied with the counseling they receive about menopause. to improve menopause counseling and help menopausal women more actively participate in the decision making process, we have developed a novel prototype web-based decision aid. our immediate goal is to develop this prototype technology into a comprehensive menopause interactive decision aid system (midas) that provides personalized feedback about menopausal symptoms, risks for common conditions, and the effects of different treatment options on the short- and long-term consequences of menopause. our main study hypotheses are that midas can: 1) lead to better decisions and improve the quality of menopausal counseling; 2) improve compliance with a chosen menopausal plan; and 3) reduce medical errors associated with the use of menopausal therapies. we propose a 2-phase study conducted over 3 years. phase i will transform the prototype application into a comprehensive midas, completing its content and risk assessment instruments, and exploring its optimal design. this will be accomplished through conduct of focus groups and usability tests. phase ii will formally evaluate the impact of midas in a randomized, controlled, multi-center clinical trial involving diverse patient populations and clinician settings. we will measure the impact of midas on the decision-making process as well as its effect on providers and outcome measures related to menopause, including compliance, quality of life, and medical errors related to menopausal therapy. analyses will evaluate the extent to which the impact of midas on these outcomes varies according to patient, practice, and physician characteristics.

Eligibility criteria:
inclusion criteria: * english-speaking * between 45 and 65 years of age * patient at participating clinics * experience menopausal symptoms or being 6 months or more past last menstrual period * have an upcoming appointment for menopausal counseling or annual physical exam (only applicable for clinical trial participants) exclusion criteria: * inability to give informed consent * dementia * age over 65 years * pre-existing terminal illness that limits life expectancy to less than 2 years * history of breast cancer or cardiovascular disease

Keywords: menopause decision aids internet hormone replacement therapy breast cancer cardiovascular disease osteoporosis
a virtual reality intervention to improve weight maintenance

Conditions: Weight Loss

Summary: the purpose of this study is to determine if use of a virtual reality platform, second life, is more effective than traditional face-to-face methods for maintaining weight loss in overweight and obese individuals.

this study has two main parts. during the first 6 months (-6 to 0 months)potential subjects will be on a diet developed by researchers at the university of kansas medical center (kumc). subsequent to 6 months, participants who lost 5% weight will begin the weight maintenance phase of the study (0-12 months). thus the total duration of the study is 18 months. approximately 68% of u.s. adults are classified as overweight or obese (bmi \>25). behaviorally based weight loss programs, typically delivered by face-to-face clinics, produce clinically significant reductions in body weight over 3-6 months. however, approximately 50% of those who lose weight regain more than 45-75% of the weight lost within 12-30 months. face-to-face clinics present many barriers and burdens to individuals including scheduling and logistical and financial burdens. virtual reality (vr) environments allow participants to create virtual representations of themselves called "avatars". an existing vr called "second life" will be used for participants randomized to vr. participants avatars attend group meetings and use headsets for voice communication to interact with each other. those not randomized to vr will participate in traditional face-to-face group weight loss intervention. the study will examine many different factors to determine if those participants in the second life group experience improved weight maintenance.

Eligibility criteria:
inclusion criteria: * men and women with a bmi of 25 to 39.9 kg/m2 * able to obtain clearance for participation from their primary care physician (pcp) * have access to a computer with internet that meets second life system requirements exclusion criteria: * report participating in a research project involving weight loss or pa in the previous 6 months * report a regular exercise or pa program * not weight stable (+/-2.27 kg) for 3 months prior to intake * unwilling to be randomized to phone or 2l clinics subsequent to weight loss * report being pregnant during the previous 6 months, lactating, or planned pregnancy in the following 18 months * report serious medical risk such as type 1 diabetes, cancer, recent cardiac event (i.e. heart attack, angioplasty, etc.) * report eating disorders as determined by the eating attitudes test using a score of 20 or greater * report current treatment for psychological issues, or taking psychotropic medications * report adherence to specialized diet regimes, i.e., multiple food allergies, vegetarian, macrobiotic, etc. * do not have access to grocery shopping and meal preparation (i.e. military, college cafeteria plan, etc.).

Keywords: obesity overweight weight maintenance
comparison of 68ga-dota-fapi-46 and 68ga-dota-2p(fapi)2 pet/ct in patients with various types of cancer

Conditions: Tumor, Solid, FAPI, PET/CT, Metastasis

Summary: to evaluate the potential usefulness of 68ga-dota-2p(fapi)2 positron emission tomography/computed tomography (pet/ct) for the diagnosis of primary and metastatic lesions in various types of cancer, compared with 68ga-dota-fapi-46 pet/ct.

in order to enhance the tumor uptake and tumor retention time, we designed the dimer structure of fibroblast activation protein inhibitor (fapi), a novel imaging agent that targeting cancer-associated fibroblasts expressed in various types of cancer, 68ga-dota-2p(fapi)2. subjects with various types of cancer underwent contemporaneous 68ga-dota-2p(fapi)2 and 68ga-dota-fapi-46 pet/ct either for an initial assessment or for recurrence detection. tumor uptake was quantified by the maximum standard uptake value (suvmax). the sensitivity, specificity, positive predictive value (ppv), negative predictive value (npv) and accuracy of 68ga-dota-fapi-46 and 68ga-dota-2p(fapi)2 pet/ct were calculated and compared to evaluate the diagnostic efficacy.

Eligibility criteria:
inclusion criteria: * (i) adult patients (aged 18 years or order); * (ii) patients with suspected or newly diagnosed or previously treated malignant tumors (supporting evidence may include magnetic resonance imaging (mri), ct, tumor markers and pathology report); * (iii) patients who had scheduled both 8ga-dota-fapi-46 and 68ga-dota-2p(fapi)2 pet/ct pet/ct scans; * (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the clinical research ethics committee. exclusion criteria: * (i) patients with non-malignant lesions; * (ii) patients with pregnancy; * (iii)the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Keywords: diagnosis, tumor, solid, fapi, pet/ct, metastasis
the effect of emotional freedom technique on menopausal symptoms, quality of life and depression level

Conditions: Menopause

Summary: emotional freedom technique will be applied to menopausal women. emotional freedom technique group, sham emotional freedom technique group and control groups each consisted of 35 menopausal women.

objective: the aim of the study was to determine the effect of emotional freedom technique (eft) on menopausal symptoms, quality of life and depression level. materials and methods: this randomized controlled trial will be conducted with a total of 105 menopausal women at fırat family health center and göztepe family health center between january 2024 and june 2024 (35 eft, 35 sham, 35 control). eft and sham eft will be applied in the study. women in the eft group will receive eft four times at one week intervals. women in the sham eft group will receive sham eft four times with one week intervals. before the applications, pre-test data will be obtained by filling out the personal information form, perimenopausal depression scale, menopause specific quality of life scale and menopause symptom assessment scale before the application of emotional freedom technique. after the applications, post-test data will be obtained by filling out the perimenopausal depression scale, menopause specific quality of life scale and menopause symptom assessment scale. in addition, the subjective units of experience (sue) scale will be applied before and after each eft intervention.

Eligibility criteria:
inclusion criteria: * a person who has gone through menopause naturally, * no menstruation for the last one year, * literate, * not taking hormone replacement therapy, * no oncologic disease, * no infection, wound, scar in the tapping areas, * women who are able to communicate will be included in the study. exclusion criteria: * one who has not gone through menopause naturally, * illiterate, * receiving hormone replacement therapy, * women with conditions such as infections, wounds, scars in the tapping areas.

Keywords: menopause symptoms quality of life depression emotional freedom technique
prediction of delayed toxic cardiomyopathy in children

Conditions: Cardiotoxicity; Childhood Cancer

Summary: longitudinal analysis of myocardial function using "speckle tracking echocardiography" ste analysis and prediction of delayed toxic induced cardiomyopathy in young patients who received anthracycline therapy in childhood.

anthracycline therapy may have short-, medium- or long-term cardiac toxicity that impacts patient's life. the main recognized risk factors for delayed cardiotoxicity are cumulative anthracycline dose, female gender, association with mediastinal radiotherapy and young age at administration. prediction of delayed cardiotoxicity in children population is still challenging. the "speckle tracking echocardiography" (ste) method, an innovative echocardiographic technique, analyses the myocardial displacement of natural acoustic markers via a software. the objective of the study is to analyze, in young patients who received anthracycline therapy in childhood, 5-years after their inclusion in the "speckle anthra" study and first ste results, the evolution of myocardial function using ste method.

Eligibility criteria:
anthra group inclusion criteria: * patients who were treated with anthracyclines for malignant disease between the ages of 0 and 18 * patient aged 11 to 27 years * included in the "speckleanthra" study (nct02893787) * discontinued chemotherapy for more than 6 years * patient in remission of malignant disease * enrolled in a social security plan * written informed consent from at least one legal representative for the minor patient/ written informed consent for patients of legal age exclusion criteria: * onset of active malignancy or recurrence of malignancy after the "speckle anthra" study that required resumption of chemotherapy or mediastinal radiotherapy. * chronic cardiac, pulmonary or muscular pathology of etiology other than secondary to anthracycline therapy * for adult patients: subject under guardianship or curators control group inclusion criteria: * control patient included in the "speckle control" study (nct02056925) * had a cardiological consultation with echocardiography performed for a banal reason (heart murmur test, cardiological symptoms) and whose result was normal * no chronic disease or long-term drug treatment exclusion criteria: * refusal to participate in the study by the patient and/or parents or legal guardian after receipt of the study's information and non-objection note.

Keywords: echocardiography ventricular function stroke volume
a study to evaluate the efficacy and safety of pemigatinib (incb054828) in subjects with myeloid/lymphoid neoplasms with fgfr1 rearrangement - (fight-203)

Conditions: MPN (Myeloproliferative Neoplasms)

Summary: the purpose of this study is to evaluate the efficacy and safety of pemigatinib (incb054828) in subjects with myeloid/lymphoid neoplasms with fibroblast growth factor receptor (fgfr) 1 rearrangement.


Eligibility criteria:
inclusion criteria: * documented lymphoid or myeloid neoplasm with 8p11 rearrangement known to lead to fgfr1 activation, based on standard diagnostic cytogenetic evaluation performed locally, before signing informed consent for this study. * eligible subjects must: * have relapsed after stem cell transplantation or after other disease modifying therapy, or * not be current candidates for stem cell transplantation or other disease modifying therapies. * note: all relapsed/refractory subjects must have evidence of either cytogenetic or hematological disease and have no evidence of residual toxicity (eg, graft-versus-host disease requiring treatment). * life expectancy ≥ 12 weeks. * eastern cooperative oncology group (ecog) performance status 0 to 2. exclusion criteria: * prior receipt of a selective fgfr inhibitor. * history and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, except calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcifications. * current evidence of corneal disorder/keratopathy, including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, and keratoconjunctivitis, as confirmed by ophthalmologic examination. * use of any potent cytochrome p450 3a4 inhibitors or inducers within 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug.

Keywords: myeloid neoplasm fibroblast growth factor receptor inhibitor fgfr1 rearrangement 8p11 eosinophilia eosinophilic syndrome lymphoid neoplasm
effect of the salbutamol on mechanical properties of respiratory system

Conditions: Smoking; Airway Obstruction

Summary: the aim of this study is to assess the bronchodilator response of salbutamol on respiratory mechanics of healthy individuals, smokers and copd with varying degrees of airway obstruction.

clinical evaluation will be conducted and anthropometric measurements, then the pulmonary function tests: forced oscillation technique (fot), whole body plethysmography, spirometry and-administration of salbutamol aerosol for assessment of bronchodilator response. after 20 minutes, the individual will be evaluated again following the same sequence.

Eligibility criteria:
inclusion criteria: * healthy individuals, smokers and patients with chronic obstructive pulmonary disease. exclusion criteria: * healthy subjects: no history of smoking respiratory infection and disease respiratory * smokers and chronic obstructive pulmonary disease patients: asthma and other respiratory diseases.

Keywords: chronic obstructive pulmonary disease, bronchial reversibility, bronchodilator, respiratory impedance, forced oscillation technique, plethysmography, spirometry diagnostic techniques, respiratory system