Kornimate/medical-research-clean huggingface dataset:
the nutrient trial (nutritional intervention among myeloproliferative neoplasms): feasibility phase

Conditions: Myeloproliferative Disorder; Myeloproliferative Syndrome; Myelofibrosis; Polycythemia Vera; Essential Thrombocythemia

Summary: the purpose of this study is to determine whether mpn patient are able to adhere to a dietary intervention. participants will be randomized to one of two healthy diets. participants will receive in person dietician counseling and online curriculum. adherence will be measured using online surveys and phone diet recalls. changes in inflammatory markers in blood will also be measured at 5 time points during this 15 week study.

this is a 15 week study, including 10 weeks of active diet intervention. each participant will receive one dietician counseling session at the beginning of the diet intervention period, two brief follow up dietician phone calls, and 10 diet education handouts delivered via email each week. the main objective of this protocol is to test whether mpn patients can adhere to a diet intervention. the investigators will measure adherence in both arms with patient reported diet recall every two weeks via internet surveys. as exploratory endpoints the investigators will measure changes in inflammatory markers, symptom burden, physical activity level, sleep, and gut microbiome in participants over the course of the study. if successful, the investigators plan to use this intervention in a larger trial to assess whether a diet intervention can effectively change symptom burden and inflammation in mpn patients.

Eligibility criteria:
inclusion criteria: * at least 18 years old * diagnosis of myeloproliferative neoplasm (mpn) including essential thrombocythemia (et), polycythemia vera (pv), or myelofibrosis (mf) * any type of previous therapy is allowed * ecog performance status ≤2 * life expectancy of greater than 20 weeks * has an email address and can access the internet * able to read and understand english exclusion criteria: * children

Keywords: nutrition diet inflammation myeloproliferative neoplasm
scar-improvement efficacy and safety of a single intradermal injection of avotermin (juvista) administered following full-thickness skin incisions

Conditions: Cicatrix

Summary: this study was undertaken to investigate the scar-improvement efficacy and safety of a single dose of avotermin (juvista) injection into skin incisions.


Eligibility criteria:
inclusion criteria: * males and females aged 18-85 years who had given written informed consent. * subjects with a body mass index within 15 to 35 kg/m2. * subjects with clinically acceptable results for the laboratory tests * female subjects of child bearing potential who are using acceptable method(s) of contraception. exclusion criteria: * subjects with history or evidence of hypertrophic or keloid scarring. * subjects with tattoos or previous scars within 3cm of the area to be incised. * subjects with prior surgery in the area to be incised within one year of the first dosing day. * subjects with a history of a bleeding disorder; receiving anti-coagulant or anti-platelet therapy. * subjects with evidence of any past or present clinically significant disease that may affect the endpoints of the trial. * subjects with a clinically significant skin disorder that is chronic or currently active. * subjects with any clinically significant medical condition or history that would impair wound healing. * subjects with a history of drug hypersensitivity to any of the drugs or dressings used in this trial. * subjects who are taking, or have taken any investigational product or participated in a clinical trial in the three months prior to first trial dose administration. * subjects who are taking regular, continuous, oral corticosteroid therapy. * subjects undergoing investigations or changes in management for an existing medical condition. * subjects with a history of drug abuse, or with a positive drugs of abuse test for cocaine, amphetamines, metamphetamines, opiates or benzodiazepines during the screening period. * subjects who are considered unlikely to complete the trial for whatever reason. * subjects with a clinically significant neurological impairment or disease. * subjects with any active infection. * subjects who are pregnant or lactating.

Keywords: scarring, juvista, avotermin, transforming growth factor beta 3, tgfb3
the turkish version of the self-perceived barriers for physical activity questionnaire

Conditions: Physical Inactivity; Health Behavior; Quality of Life

Summary: the self-perceived barriers for physical activity questionnaire (sbpaq) is originally developed in spanish to evaluate self-perceived barriers for physical activity participation in healthy individuals. the purpose of this study is to translate and cross-culturally adapt the sbpaq into turkish and investigate its psychometric properties.

the self-perceived barriers for physical activity questionnaire (sbpaq) is originally developed in spanish to evaluate self-perceived barriers for physical activity participation in healthy individuals. the purpose of this study is to translate and cross-culturally adapt the sbpaq into turkish and investigate its psychometric properties. approximately two hundred healthy individuals aged between 18-65 years will be included. for cross-cultural adaptation, two bi-lingual translators will use the back-translation procedure. after the questionnaire will be translated into turkish, the reliability, validity, and internal consistency of the turkish version of sbpaq (sbpaq-t) will be tested. the questionnaire will be applied twice within 7 days to evaluate the test-retest reliability and to calculate the "intraclass correlation coefficient" (icc). pearson correlation coefficient will be used to analyze construct and convergent/divergent validity. the construct validity of sbpaq-t will be analyzed based on its correlation with the physical activity barriers questionnaire, international physical activity questionnaire-short form, and short form-12. the cronbach's alpha will be calculated to determine internal consistency. the level of significance is considered as 0.05. the floor and ceiling effects will be detected.

Eligibility criteria:
inclusion criteria: * being aged between 18-65 years * having the ability to read and write turkish * having good cooperation to complete the assessment * being a volunteer to participate in the study exclusion criteria: * having any musculoskeletal disease, cardiorespiratory system problem, or movement limitation in any joint that prevents participation in physical activity * having undergone surgery affecting the musculoskeletal system in the last 3 months * being pregnant * having a neurological or cognitive impairment * having any movement disorder * having the vision and/or hearing problems

Keywords: health physical activity psychometrics quality of life
the effect of food supplements on food intake and gut hormone levels

Conditions: Obesity; Endocrine; Obesity; Appetite; Perverted

Summary: when a meal is eaten, nutrients activate the release of hormones from the bowel into the blood stream. normally there is a large amount of hormone released, which tells the brain that an individual is full and to stop eating. when people gain weight and become overweight or obese, these hormone signals are reduced, resulting in these people eating more and gaining more weight. this study is investigating mechanisms which may break this cycle by using particular nutrients to restore reduced hormone levels.


Eligibility criteria:
inclusion criteria: * obese but otherwise healthy volunteers, * body mass index (bmi) of 30-40 kg/m2 * agreement to consume scheduled meals * ability to understand the study information sheet and instructions in english and able to provide informed consent. exclusion criteria: * not meeting any of the exclusion criteria above. * major gut surgery * major health problems * taking medication for diabetes

Keywords: nutrient anorexigenic hormone calorific intake
study of 225ac-ss0110 in subjects with es-sclc or mcc (santana-225 )

Conditions: Small Cell Lung Cancer Extensive Stage; Merkel Cell Carcinoma

Summary: this study aims to determine safety, tolerability, recommended phase 2 dose (rp2d), and preliminary antitumor activity of 225ac-sso110 with standard of care (soc) therapy in patients with somatostatin receptor 2 expressing (sstr2+) extensive-stage small cell lung cancer (es-sclc) and recurrent locally advanced or metastatic merkel cell carcinoma (mcc).


Eligibility criteria:
key inclusion criteria: signed informed consent form and willing to comply with all study procedures. participants with es-sclc (defined as stage iv per nccn guidelines version 1.2024) or recurrent locally advanced or metastatic mcc (per nccn guidelines version 1.2024) documented by histology or cytology. participants eligible to receive immune checkpoint inhibitor (cpi) monotherapy at the start of treatment with 225ac-sso110 or patients already on cpi monotherapy for 7 weeks. ecog performance status of 0 or 1. life expectancy of at least 6 months. positive 68ga-sso120 scan (investigator-assessed) during screening. key exclusion criteria: participants with unstable spinal cord compression. any previous systemic radioligand therapy or extensive radiotherapy. participants receiving or planned to receive consolidative chest radiation. history of primary immunodeficiency, transplantation or car-t cell therapy. major surgical procedure except diagnostic biopsy within 28 days prior to enrolment or scheduled to have major surgery during the study. inadequate organ or marrow function.

Keywords: actinium 225ac actinium-225 sso110 sso120 gallium 68ga gallium-68 radiopharmaceutical mcc merkel cell carinoma es-sclc extensive stage small cell lung cancer radioligand somatostatin receptor 2 jr11 sstr2-antagonist
behavioral economics-based online lifestyle balance program

Conditions: Weight Reduction; Health Knowledge, Attitudes, Practice

Summary: the objective of this project is to design a behavioral economics based online lifestyle balance program that employs behavioral economics to engage and motivate adherence to an internet-based program. the investigators compare the effects of two financial incentives on inducing weight loss: a direct financial incentive for weight loss and a financial incentive for health literacy.

this project investigates whether participants in an online weight loss program can be induced to achieve weight loss using financial incentives. the study is a 3-arm randomized controlled trial (rct) stratified by gender. the goal is to examine how overweight individuals respond to two different types of financial incentives. the first type of incentive, incentive for weight loss (iw), is a cash award of approximately $150 given for achieving 5% weight loss over 12 weeks. the second type of incentive, incentive for education (ie), is a $150 award for passing quizzes that test the participants' health literacy about weight loss and the techniques required for maintaining a healthy lifestyle. the investigators compare the effectiveness of iw to ie in promoting weight loss in overweight individuals and investigate whether the two incentives work equally well for men and women.

Eligibility criteria:
inclusion criteria: * bmi between 23 and 33 * age between 40 and 60 years old exclusion criteria: * history of diabetes * history of significant cardiovascular disease * family history of atherosclerosis * high blood pressure * significant lung disease

Keywords: weight reduction health literacy financial incentives lifestyle change
an investigator-blind multi-center prospective study for the efficacy and safety of silicon gel (dermatix)

Conditions: Hypertrophic Cicatrix

Summary: silicone gel is a self-drying silicone polymer that forms thin film after application onto the skin. because silicone film is a medical device, silicone gel is also regarded as a medical device. silicone gel has been on the market for many years for the management of scar in the phase of treatment as well as in the phase of prevention. in contrast to other methods that are expensive, invasive or inconvenient, silicone gel is convenient, non-invasive and also reasonably priced. however, the number of well-designed clinicial trials for efficacy and safety are not enough to provide robust evidences in making clinical decisions for scar management options. in a prospective, multi-center, investigator-blind randomized half-split study for patients undergoing cesarean sections, the investigators attempt to provide valid information for the efficacy and safety of silicone gel in the prevention phase of scar.

prospective subjects will be enrolled in the trial when eligibility screening and informed consent were made. one day after stitch out for cesarean sections, subjects will be asked to start applying silicone gel as the instruction to the randomly designated half of the wound 2 times a day for 12 weeks. subjects are asked to make visits on week 4, 8, and 12 for efficacy, safety and compliance evaluations. obstetricians, dermatologists and medical imaging specialists are involved in the trial for the evaluation of efficacy, safety and compliance. sample size calculation as well as statistical analysis will be conducted by a designated statistician. study product will be provided by the manufacturer at no cost and patient visits and relevant lab exams will be conducted free of charge.

Eligibility criteria:
inclusion criteria: * pregnant female of 20-45 in ages equal to or beyond 34th of pregnancy * those who understand and agree on the trial conditions exclusion criteria: * keloid (by present and past medical history) * secondary infection, and/or dermatitis in and around c/s wound * hypersensitivity to the study agent * diabetes * (pre)eclampsia
the effect of soy isoflavone supplementation on endothelial function

Conditions: Cardiovascular Disease; Osteoporosis

Summary: a randomized double blind controlled trial was conducted to evaluate the effect of daily supplementation with soy isoflavone 100 mg/day for 12 months on 182 postmenopausal women aged 47 to 60 years at subdistrict south jakarta indonesia. the study hypothesis was supplementation soy isoflavone 100 mg/day for 6 and 12 months can increase endothelial function.

the subject were randomized to the intervention group receiving tablets consisting of 100 mg soy isoflavone and calcium carbonate 500 mg and the control group receiving 500 mg calcium carbonate for 1 year. this study was carried out 13 months(13 x 28 days). there were three outcome measure from this study; vascular cell adhesion molecule-(vcam-1), nitric oxide (no) and malonyldialdehyde (mda). the outcome measure will be assessed at three times; before soy isoflavone supplementation / the beginning of study,post supplementation 6 months and 12 months. the outcome will be measured change from baseline in the level of vcam-1, no and mda.

Eligibility criteria:
inclusion criteria: * healthy postmenopausal women * natural cessation 1-10 years * body mass index \<=35 kg/m2 * not receiving medication and supplement in the previous 6 months exclusion criteria: * has chronic or terminal disease * severe psychosis

Keywords: endothelial function postmenopausal soy isoflavone supplementation osteoporosis
does resistance training protocol change micromorphology in achilles tendinopathy?

Conditions: Achilles Tendinopathy

Summary: this work is designed as a prospective cohort study, in which the effects of a protocol of 12-week resistance training loading the achilles tendon in patients with achilles tendinopathy (at) will be monitored. it is estimated that at least 20 patients will participate. in addition, there will be a small control group of healthy participants which will not complete the same protocol, but will be monitored for natural changes in same objectives. group of patients will be instructed to perform a training protocol.

the research within one participant will last a total of 26 weeks from the initial to the final examination and will include control measurements at 6 and 12 weeks from the beginning of therapy. potential participants will be selected based on the recommendation of a specialist doctor and their suitability will be assessed according to the inclusion criteria. they will then be invited to an initial examination. this will include an objective examination by a physiotherapist, a subjective assessment by the patient and an ultrasonographic (usg) examination followed by a micromorphological analysis using special software. at the end of the initial examination, the participant will be informed about training protocol.

Eligibility criteria:
inclusion criteria: * the patient shows symptoms of achilles tendinopathy (pain, swelling and dysfunction in the area of achilles tendon), which at least partially limit his quality of life during normal or sporting activities, * the patient is in the age group of 18-60 years, * the patient has difficulties in only one lower limb; the second, asymptomatic limb will be considered the reference, * the patient is not aware of any mechanical damage to the tendon in symptomatic limb in the past (e.g. partial or complete rupture as a result of an injury), * the patient has not undergone any treatment aimed at as in the last 3 months (surgery, corticoid application, plasma therapy, shock waves, physiotherapy, etc.), objective us examination of as shows structural changes (expansion, neovascularization, focal hypoechoic areas, etc.). exclusion criteria: * patient has been diagnosed with a rheumatic disease or a disease of the central nervous system * patient is aware of mechanical damage to the achilles tendon as a result of an injury in the past.

Keywords: achilles tendinopathy ultrasonography resistance training
personalized ultrasonic brain stimulation for depression

Conditions: Major Depressive Episode

Summary: this study will evaluate a new form of non-invasive brain stimulation for individuals with depression. personalized low-intensity transcranial focused ultrasound stimulation will first be delivered using a range of stimulation parameters during psychological and physiological monitoring. a well-tolerated stimulation protocol will then be selected for subsequent testing in a blinded randomized sham-controlled cross-over trial to evaluate brain target engagement using magnetic resonance imaging.


Eligibility criteria:
inclusion criteria: 1. age 18-65, any gender 2. primary diagnosis of major depressive disorder or bipolar disorder 3. current moderate-to-severe depressive episode, without psychotic features, lasting at least 2 months 4. self-rated 16-item quick inventory of depressive symptomatology (qids) total score \> 10 5. stated willingness to comply with all study procedures and avoid changes to psychiatric treatments (medications, psychotherapy) for the duration of the study 6. for females of reproductive potential: negative pregnancy test or use of highly effective contraception for at least 1 month prior to baseline; agreement to use such a method throughout the study 7. capacity to provide informed consent; provision of a signed and dated consent form exclusion criteria: 1. history of serious brain injury or other neurologic disorder 2. poorly managed general medical condition 3. pregnant or breast feeding 4. implanted device in the head or neck 5. mri intolerance or contraindication 6. brain stimulation (e.g., ect, tms, vns) in the past month 7. suicidal ideation (columbia suicide severity rating scale screen item #2, past month) 8. lifetime history of a serious suicide attempt 9. moderate-to-severe substance use disorder (past 3 months) 10. obsessive compulsive disorder (past month) 11. posttraumatic stress disorder (past month) 12. schizophrenia-spectrum disorder (lifetime) 13. neurocognitive disorder (past year) 14. personality disorder as a current focus of treatment 15. clinically inappropriate for participation in the study as determined by the study team
decreasing rates of intraurethral catheterization postoperatively in spine surgery

Conditions: Post-operative Urinary Retention

Summary: randomization (1:1) of male patients, over age 50, undergoing elective spine surgery to tamsulosin versus a placebo.

postoperative urinary retention (pour) is a common complication following certain surgical operations. while much is known about the innervation and neural regulation of bladder emptying and storage, the cause of urinary retention after surgery is not fully understood. early research has indicated that a small dose of tamsulosin (flomax®), a commonly used medication approved to treat urinary symptoms in men with benign prostatic hypertrophy, may reduce the incidence of pour. urinary retention is a prevalent issue in patients undergoing spinal surgery, leading to patient discomfort and prolonged length of stay. we hypothesize that the use of perioperative tamsulosin in patients undergoing spinal surgery will decrease the incidence of pour. the study is a prospective, double-blind, randomized, placebo-controlled trial. subjects will be randomized 1:1 to receive either oral tamsulosin 0.4 mg or placebo, taken once each evening, beginning 5 days prior to surgery and continuing through the first postoperative day. the primary endpoint is met when the patient is able to spontaneously empty their bladder post-operatively, or needs to be catheterized with either a straight or indwelling urinary catheter for post-operative urinary retention, whichever occurs first.

Eligibility criteria:
inclusion criteria * male patient age 50 - 85 years * undergoing elective spine surgery at least 5 days after enrollment * preop visit done at office practice exclusion criteria: * currently on tamsulosin or other alpha-adrenergic blocking drug * allergy to tamsulosin * allergy to lactose * serious or life-threatening allergy to sulfa drugs * emergent procedure * history of spinal trauma, spinal infection or spinal cord tumor * pre-existing indwelling urinary catheter * history of orthostatic hypotension or current orthostatic hypotension * history of prostate, urethral or bladder surgery * renal failure * non-english speaking * unable to provide informed consent