Kornimate/medical-research-clean huggingface dataset:
a non-interventional study to evaluate time to event and healthcare resource utilisation for prostate cancer participants throughout the disease trajectories until progression or death

Conditions: Prostate Cancer

Summary: primary objective of this study is to describe the time in each prostate cancer stage from non-metastatic hormone sensitive prostate cancer (m0hspc), metastatic hormone sensitive prostate cancer (m1hspc), non-metastatic castrate-resistant prostate cancer (m0crpc), metastatic castrate-resistant prostate cancer (m1crpc) to progression or death. the secondary objectives of this study are to describe co-medication at each disease stage, to describe co-morbidities at each disease stage and to describe the healthcare resource use and costs associated to each disease stage. this study has been opened and amended (amendment 2; also known as 9785-ma-3631 study) to describe the time in each prostate cancer state from m1hspc to progression or death. the secondary objective for amendment 2 is to describe co-medication at each disease state, describe co-morbidities at each disease state, and describe pca treatments in the m1hspc state. the aim of the second amendment is to provide up to date real world data on the change of the treatment landscape in the m1hspc population from 1 january 2021 to 30 june 2024.

this is a retrospective analysis of prostate cancer patients from m0hspc, m1hspc, m0crpc, m1crpc followed in the prostate cancer database sweden (pcbase) database. the patient population consists of men recorded in patient-overview prostate cancer (ppc) between 1 january 2014 until death or 31 december 2016. patient history to 2006 was collected by retrospective charted review. data will be extracted from ppc for the different prostate cancer (pca) disease stages, from m0hspc, m1hspc, m0crpc, m1crpc until progression or death. the prostate cancer disease progression from m0hspc, m1hspc, m0crpc, m1crpc until progression or death has not been recorded in a systematic way. given the complexity of this disease, the aim of this study is to have a comprehensive understanding about the disease progression in prostate cancer, from m0hspc, m1hspc, m0crpc, m1crpc until progression or death. in addition, the following will be collected: co-morbidities, co-medication, health care resource utilization and costs, as well as other health economic variables such as sick leave and early retirement at the different disease stages.

Eligibility criteria:
inclusion criteria: * all patients registered in ppc. exclusion criteria: * none.

Keywords: prostate cancer non interventional registry
navigated microsecond laser for chronic central serous chorioretinopathy: micropulse

Conditions: Central Serous Chorioretinopathy

Summary: micropulse study aims to evaluate the efficacy of navigated microsecond laser (nmsl) for chronic central serous chorioretinopathy (cscr).

chronic central serous chorioretinopathy (cscr) is characterized by persistent subretinal fluid (srf) and extensive outer retinal damage on optical coherence tomography (oct). in the last years several treatment modalities for chronic cscr have been investigated. these treatments have included pharmacologic therapy, photodynamic therapy (pdt) and microsecond laser. pdt is the main treatment for cscr, especially for chronic cscr. but the efficacy of pdt is variable and could be associated with various complications such as retinal pigment epithelium (rpe) atrophy. furthermore other limitations of pdt are unavailability and high cost. recently some studies have suggested an efficacy of micropulse laser in chronic cscr, with stabilization of visual acuity, improvement in retinal sensitivity and without any complications. the present study aims to evaluate the efficacy of a treatment by guided micropulse laser in the management of chronic cscr. the efficacity will be evaluated 6 weeks and 3 months after the treatment on anatomical outcomes (central macular thickness in microns)

Eligibility criteria:
inclusion criteria: * 18 years and older * vision complaints for more than 6 weeks * subretinal fluid confirmed on oct * diagnosis of cscr confirmed by fluorescein and indocyanine green angiography * signed informed consent * affiliated or beneficiary of health insurance exclusion criteria: * history of treatment of csc with other modalities (pdt, eplerenone) in the past 3 months * other macular conditions : age-related macular degeneration (amd), polypoidal vasculopathy, choroidal neovascularization * cataract or opacities interfering with acquisition or treatment * myopia\> 6 diopter * visual acuity\<20/200 * treatment with steroids (per-os, inhaled or cutaneous) in the past 3 months * intra-vitreal injections of anti-vegf (vascular endothelial growth factor) or steroids in the past 3 months * history of allergy to fluorescein or indocyanine * inability to agree to participate to the study * pregnant or breastfeeding woman * patient under legal protection

Keywords: retina photodynamic therapy micropulse laser central serous chorioretinopathy
follow up 18f-av-1451 scan in confirmatory cohort subjects from study 18f-av-1451-a05

Conditions: Alzheimer's Disease

Summary: this study will evaluate longitudinal change of tau deposition as measured by flortaucipir f 18 uptake over time.


Eligibility criteria:
inclusion criteria: * confirmatory cohort subjects who completed the 18f-av-1451-a05 (nct02016560) study exclusion criteria: * current clinically significant cardiovascular disease, ecg abnormalities, risk factors for torsades de pointes (tdp), or are taking drugs known to cause qt prolongation * current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer * females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception * have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session * have received or participated in a trial with investigational medications in the past 30 days
time,self and spontaneous mental activities in patients with psychotic disorders

Conditions: Schizophrenia; Bipolar Disorder

Summary: the main purpose of the study is to examine to which extent abnormalities in the dynamics of neural activities observed in patients with psychosis is related to difficulties at ordering simple visual stimuli and/or personal events.


Eligibility criteria:
inclusion criteria: * age between 18 and 60 years * affiliation to a social security insurance * written consent given * only for patient : dsm criteria for schizophrenia or bipolar disorder exclusion criteria: * addiction problem * invalidating visual sensory problems * neurological history * pregnancy or breastfeeding * legal safeguard * participation in another clinical trial * contraindication to mri
antro-pyloro-duodenal motility in idiopathic gastroparesis

Conditions: Gastroparesis

Summary: impaired gastric emptying may cause dyspeptic symptoms including nausea, vomiting and even nutritionnal impairment. delay in gastric emptying may result from antro-pyloro-duodenal motility impairement.

the aim of this study is therefore to measure antro-pyloro-duodenal motor activity in patients with idiopathic gastroparesis.

Eligibility criteria:
inclusion criteria: * idiopathic gastroparesis or healthy volunteers * idiopathic gastroparesis must have delayed gastric emptying shown using c13 breath test exclusion criteria: * diabetic or post-surgical gastroparesis * treatment modifying gi motility (prokinetics, opioids...) * parkinson or neurologic disease * evoluting inflammatory process or neoplasia * treatment modifying coagulation * patients not affiliated to the french healthcare insurance

Keywords: gastroparesis gastric emptying antro-duodenal manometry
assessing pain as a mediator of behavior change in post-coronary angioplasty patients

Conditions: Pain; Depressive Symptoms; Quality of Life

Summary: the focus of this secondary data analysis is to determine whether pain due to a combination of both cardiac and non cardiac sources operates as a mediator of behavior change, an area that has not been previously evaluated.

this is a secondary data analysis of an existing dataset generated from the healthy behavior trial, an nhlbi-funded randomized controlled trial that enrolled 660 post-coronary angioplasty patients between october 1999 and march 2001. this study employed a behavioral intervention to motivate pci patients to adopt health behaviors in order to reduce major cardiac and neurologic morbidity and mortality. patients in the experimental arm were told their estimated biologic age (calculated from the health risk assessment) and risk factors were presented in terms of "biologic age reduction" that could be achieved if a change was made in each health behavior area. those in the control arm were provided with risk factors (also obtained from the health risk assessment) and told that changing each health behavior could "increase your lifespan." specific aims: utilizing 12 month longitudinal data for patients with cardiovascular disease who have undergone coronary angioplasty we will: specific aim 1: determine if pain is a mediator of health behavior change over 12 months. specific aim 2: assess behavior change patterns over 12 months, stratifying for degree of pain, depression and/or stress. specific aim 3: evaluate the effect of pain on quality of life (physical, social, role-physical, role-emotional, vitality, mental health, bodily pain and general health domains), combined major cardiac and neurologic morbidity/mortality and hospitalizations over 12 months.

Eligibility criteria:
inclusion criteria: * all patients in the database who had participated in the healthy behavior trial. the healthy behavior trial was a randomized controlled trial of a psychoeducational intervention designed to motivate multi-behavior change (changing 2 or more cardiovascular risk factors) in post-coronary angioplasty patients over the course of 24 months. exclusion criteria: * non-participants in the healthy behavior trial

Keywords: pain health behavior change coronary angioplasty cardiovascular disease outcomes morbidity mortality
dynamic full-field optical coherence tomography for structural and microbiological characterization of central venous catheter-deposited biofilm in critically ill patients

Conditions: Healthcare Associated Infection; Critically Ill; Central Venous Catheter Associated Bloodstream Infection

Summary: 29.3% of bacteremias in intensive care units (icu) are linked to vascular devices, with a significant proportion related to central venous catheters, and an influence on both morbility and mortality. it is now accepted that microbiological biofilm plays a key role on both bacterial and fungal development on inner surface of vascular devices but there is yet a lack of clinical relevant data documenting a causal relation between biofilm formation and bacteremias. we assume that a more precise characterization of central venous catheter-deposited biofilm could help us better understand invasive medical device-related healthcare infections in critically ill patients.


Eligibility criteria:
inclusion criteria: * patient or relative informed of the study and having declared their nonobjection * patient over 18 years of age * patient exposed to central venous catheter for at least two calendar days exclusion criteria: * patient unable to declare their nonobjection * patient whose central venous catheter collection is impossible * patient admitted in icu with a central venous catheter already in place
hemostatic and analgesic effect of gel foam and gauze with bosmin after anal surgery

Conditions: Hemorrhoids; Anal Fistula

Summary: to evaluate the hemostatic and analgesic effect of using gauze with bosmin or gelfoam after anal surgery.

hemorrhoidectomy and fistulotomy these two types of anal surgery are common surgeries in colon and rectal surgery division in shuang ho hospital. for these patients underwent surgical treatment, some surgeons used gauze with bosmin for hemostasis and analgesia after surgery, and other surgeons used gelfoam. these choices were often determined by surgeon's personal preference according to their experiences. shuang ho hospital has top three quantity of hemorrhoidectomy in taiwan. so, a randomized controlled trial is conducted to evaluate the difference between hemostatic agents use after anal surgery.

Eligibility criteria:
inclusion criteria: * patients who undergo conventional hemorrhoidectomy or stapled hemorrhonidpexy are include. * patients who undergo fistulectomy or fistulotomy are include. exclusion criteria: * emergency operation * patients with colorectal cancer * liver cirrhosis * patients with coagulopathy * patients with hiv infection
recruit blood donors via sms during epidemic of covid-19 #second repeat trial#

Conditions: Blood Donation

Summary: the fight against the spread of the 2019-ncov epidemic has achieved some success in china, but the epidemic is far from over. a key factor making the epidemic under control in china is the government's call for social distance, which has led to few people going out for donation. as a result, the number of blood donors on the streets has been continuing to decline. the first urgent recruitment of blood donors had been implemented during the period from 30 april to 10 may via emergency recruitment sms . this second repeat trial has been designed to further confirm the results from the the first recruitment by comparing which information extraction frameworks would be more sensitive to blood donors in emergency situations.

researches has showed that that the information extraction and processing in emergency was different from the normal situation. to understand what information the blood donors are more sensitive to in an environment that may pose a potential threat to themselves, the first urgent recruitment of blood donors had been implemented during the period from 30 april to 10 . this interventional study is the second repeat trail of the first trail. the same with first trail, eligible blood donors in guangzhou blood center has been randomly divided into four groups according to their sociological variables, their interval since last blood donation , their history donation times and the location of their last blood donation. three groups of donors has been randomly selected as interventional groups, and will receive three kindly of emergency blood donor recruitment sms respectively. the placebo group donors will only receive a thank-you sms. one recruitment sms will emphasize what blood services will do to ensure the safety of blood donors during their donation in 2019-ncov epidemic,one will shows information about a loss-based framework, while the third one will show information about a benefit-based framework .

Eligibility criteria:
inclusion criteria: * blood donors whose last turning up were between december 10, 2016 to december 10, 2019 exclusion criteria: * blood donors who were deferral by blood screening result and other situations. blood donors who have indicated that they would not accept urgent recruitment.
a study to compare the efficacy and safety of topical administration of fmx-101 for treatment of moderate-to-severe acne

Conditions: Acne Vulgaris

Summary: this is a phase 3 study to evaluate the efficacy, safety and long-term safety of the topical administration of fmx-101, 4% minocycline foam for the treatment of moderate-to-severe acne vulgaris.

this is a phase 3 study to evaluate the efficacy, safety and long-term safety of the topical administration of fmx-101, 4% minocycline foam for the treatment of moderate-to-severe acne vulgaris. the first 12 weeks of the study involves randomized, double-blind treatment with active fmx-101, 4% or matching vehicle. subjects who successfully complete the 12-week double blind portion of the study will be offered the opportunity to continue in the trial for up to an additional 40 weeks (for a total of 1 year) and receive open-label treatment with fmx-101, 4%.

Eligibility criteria:
inclusion criteria: * has facial acne vulgaris with: * 20 to 50 inflammatory lesions (papules, pustules, and nodules) * 25 to 100 noninflammatory lesions (open and closed comedones) * no more than 2 nodules on the face * iga score of moderate (3) to severe (4) * willing to use only the supplied non-medicated cleanser (cetaphil gentle skin cleanser) and to refrain from use of any other acne medication, medicated cleanser, excessive sun exposure, and tanning booths for the duration of the study exclusion criteria: * acne conglobata, acne fulminans, secondary acne (chloracne, drug induced acne) or any dermatological condition of the face or facial hair (eg, beard, sideburns, mustache) that could interfere with the clinical evaluations * sunburn on the face

Keywords: acne
hiit in sedentary obese adults: effects on metabolic risk, body composition, and fabp4

Conditions: High-Intensity Interval Training

Summary: it is aimed to investigate the responses of fatty acid binding protein 4 (fabp4), which has been discovered as a novel biomarker of obesity and metabolic diseases, to regular exercise training. the aim of this study is to investigate the effects of high-intensity interval training (hiit) on cardiometabolic risk factors, body composition, and plasma fabp4 levels in sedentary obese adults.

fatty acid binding proteins are intracellular proteins involved in the transport of fatty acids and are particularly associated with lipolytic activity. these proteins constitute a group of molecules that regulate intracellular lipid responses and are linked to metabolic and inflammatory pathways. studies have shown that fabp4 is associated with hypertension, insulin resistance, obesity, and stroke. inhibition of fabp4 synthesis has emerged as a promising strategy for the treatment of obesity-related conditions, particularly insulin resistance and diabetes, and it is emphasized that exercise models to suppress fabp4 should be further investigated. the aim of this study is to investigate the effects of high-intensity interval training (hiit) on cardiometabolic risk factors, body composition, and plasma fabp4 levels in sedentary obese adults. hypotheses: h01: hiit has no effect on cardiometabolic risk factors in sedentary obese adults. h02: hiit has no effect on body composition in sedentary obese adults. h03: hiit has no effect on plasma fabp4 levels in sedentary obese adults.

Eligibility criteria:
inclusion criteria: * aged between 20 and 35 years, * bmi between 30 and 35 kg/m², * waist circumference of 90-100 cm for women, 105-110 cm for men, * sedentary lifestyle (\<600 met-min/week), * referred by a physician (with a statement confirming no contraindication to exercise)." exclusion criteria: * bmi \> 35, * pregnancy, * cardiovascular diseases: individuals with serious cardiovascular issues, such as uncontrolled hypertension, heart failure, coronary artery disease, or a heart attack within the last 6 months, which could pose a risk during exercise. * respiratory diseases: individuals with chronic respiratory conditions, such as uncontrolled or severe asthma or copd, who cannot tolerate exercise due to their condition. * neurological disorders: individuals with neurological issues that limit exercise capacity, such as parkinson's disease, stroke, or multiple sclerosis. * musculoskeletal issues: individuals with chronic musculoskeletal problems, particularly knee or hip osteoarthritis, that may increase the risk of pain or injury during exercise. * metabolic or endocrine disorders: individuals with uncontrolled metabolic issues, such as diabetes or thyroid disorders, that could cause blood sugar or hormonal fluctuations during exercise. * acute infections or illness: individuals with acute infections, fever, or recently undergone surgical procedures. * any health condition that may prevent participation in exercise."
intervention programs for decreasing caregiver burden in caregivers of patients with dementia

Conditions: Alzheimer's Disease; Dementia

Summary: the purpose of this study is to investigate if behavioral intervention for dementia caregivers will decrease caregiver burden in caregivers of patients with dementia. this multicenter, randomized trial will be conducted with 80 dementia caregivers, who will be randomized into two groups. one group consists of 40 participants who will receive behavioral intervention and 40 who will not receive intervention (waitlist control). the waitlist control group will be also provided the same intervention after the intervention group has completed the intervention. the behavioral intervention consists of 90-min-session a day with an interval of two weeks for 2 months. the primary outcome measures are the changes in scores of zaret's burden inventory and philadelphia geriatric center for moral scale (pgcms).

this multicenter, randomized trial will be conducted with 80 dementia caregivers, who will be randomized into two groups. one group consists of 40 participants who will receive behavioral intervention and 40 who will not receive intervention (waitlist control). the waitlist control group will be also provided the same intervention after the intervention group has completed the intervention. the behavioral intervention consists of 90-min-session a day with an interval of two weeks for 2 months. the intervention program includes not only the knowledge of dementia and how to manage behavioral problems of patients with dementia but also individual psychological counselling about caregiver's distress. the primary outcome measures are the changes in scores of zaret's burden inventory and philadelphia geriatric center for moral scale (pgcms). secondary outcomes are changes in scores of neuropsychiatric inventory and korean -instrumental activities of daily living of patients as well as depression scores of caregivers.

Eligibility criteria:
inclusion criteria: * 30-80years old * caregivers who spend their own time with dementia patients over 4 hours a day * caregiver distress scores \>= 2 * caregivers of patients in alzheimer's disease dementia ( mild to moderate stage of dementia, mini-mental status examination:10\~26) exclusion criteria: * illiterate * severe hearing/visual acuity difficulty * cognitive impairment

Keywords: caregivers
an open label extension study of stx209 in subjects with fragile x syndrome

Conditions: Fragile X Syndrome

Summary: study 22001, "a double-blind, placebo-controlled, flexible-dose evaluation of the efficacy, safety, and tolerability of stx209 in the treatment of irritability in subjects with fragile x syndrome" currently is evaluating the efficacy of stx209 (r-baclofen) for management of typical problem behaviors, such as irritability and aggression, in subjects with fxs. this study (22002) will enter subjects who complete study 22001 into a long-term, open-label study.the open-label extension protocol will provide necessary data on the long-term safety and tolerability of stx209 among subjects with fxs who receive treatment under conditions more closely reflective of their general medical care.


Eligibility criteria:
inclusion criteria: * have completed all scheduled visits in protocol 22001 and have shown they can adequately follow the protocol, with sufficient medical justification to continue on open-label treatment with stx209, as assessed by the principal investigator exclusion criteria: * subjects with a medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being. * the occurrence or continuation of any adverse event or condition during study 22001 that, in the opinion of the investigator, should exclude the subject from participating in this open-label extension.

Keywords: fragile x syndrome