Kornimate/medical-research-clean huggingface dataset:
testing the impact of thrive app versions on alcohol use and posttraumatic stress after recent sexual assault

Conditions: Posttraumatic Stress Symptom; Alcohol Drinking; Alcohol Problem

Summary: the goal of this study is to find the most effective and efficient version of the thrive app. the thrive app is the first app-based preventative intervention that has been found to reduce alcohol misuse and posttraumatic stress in people who have recently experienced sexual assault. in this trial, participants are randomly assigned to receive different versions of the thrive app to compare their impact. the thrive app is currently only available to participants in this study.


Eligibility criteria:
inclusion criteria: * have reached the legal age of majority in their current state of residence * be able to read and speak english fluently * own a smartphone that cannot be accessed by others while the study app is installed, or they agree to take steps to reduce the risk that someone else will access the study app * be an enrolled undergraduate or graduate student at a recruitment site at the time of screening, or if they are on summer break, plan to be enrolled in the upcoming fall term * reside in the same state as the recruitment site for most of the year * have experienced a sexual assault (i.e., unwanted and non-consensual attempted/completed sexual contact) within the past 12 weeks at the time of screening * report ≥1 past-month heavy drinking episode (i.e., 5+ drinks on a given day or 15+ drinks in a given week for participants assigned male at birth and 4+ drinks on a given day or 8+ drinks in a given week for participants assigned female or intersex at birth) at the time of screening * endorse elevated posttraumatic stress symptoms at screening (defined as a score above a pre-established cut point on a screening measure of ptsd). exclusion criteria: * active psychosis * location outside of the us at the time of screening

Keywords: sexual assault mobile health intervention
open-label study of subcutaneous secukinumab to evaluate efficacy and safety in patients with plaque psoriasis who had inadequate response to cyclosporine a

Conditions: Plaque Psoriasis

Summary: the purpose of this study was to assess the efficacy and safety of secukinumab at week 16 based on psoriasis area and severity index (pasi) 75 in subjects who had inadequate response to cyclosporine a.


Eligibility criteria:
inclusion criteria: * plaque psoriasis diagnosed for at least 6 months before baseline - treated with cyclosporine a for at least 12 weeks prior to baseline * currently treated with cyclosporine a at baseline for psoriasis but is a primary or secondary inadequate response as defined at baseline by: * pasi score of 10 or greater and * iga mod 2011 score of 2 or greater (based on a scale of 0 to 4) exclusion criteria: * forms of psoriasis other than plaque (e.g., pustular, erythrodermic and guttate psoriasis). -drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers, calcium channel blockers or lithium). * patients who have to discontinue cyclosporine a treatment due to side effects like renal impairment (serum creatinine exceeding 176.8 μmol/l \[2.0 mg/dl\]) and hypertension at screening. other protocol-defined inclusion/exclusion criteria may apply

Keywords: cyclosporine a
viscoturf - preventing secondary diabetic foot ulceration.

Conditions: Diabetic Foot

Summary: diabetic foot ulceration (dfu) is one of the most common complication of diabetes costing the nhs over £970m annually. management of foot ulcers is time-consuming and expensive with 45% taking more than six months to heal. around 25% of patients re-ulcerate in 3 months, 40% within 1 year and 60% within 3 years and patients who have achieved wound closure are generally considered to be in remission rather than healed. a patient presenting with a foot ulcer has a greatly elevated risk of amputation while 80% of amputations can be prevented with the appropriate treatment, such as footwear intervention. viscoturf is a novel, 3d printed, orthotic device designed specifically for this purpose. it emulates the function of natural turf to provide cushioning, optimised offloading and better microcirculation on the vulnerable areas of the plantar surface of the foot. this improves perfusion (the delivery of blood to the capillary bed) in the load bearing regions of the foot where the risk of re-ulceration is very high. an earlier feasibility study established proof-of-concept, showing viscoturf achieved a higher and longer-lasting increase in perfusion compared to conventional support structures. viscoturf insoles can be automatically designed to the foot size and 3d printed. the main purpose of this study is to investigate the immediate effect of walking in viscoturf insole (turf-like insoles) on skin perfusion and pressure at the sole of the foot in diabetic patients with history of ulceration. to achieve this, the immediate efficacy (effect as a result of walking for 15 meters) of viscoturf insole will be assessed and compared to that of the standard flat insole. intervention insole will be produced as 3d printed insole with the turf-like patches incorporated in the areas of interest, while the standard insole will be a standard 3d printed flat with no turf-like patches.


Eligibility criteria:
inclusion criteria: * type 1 or type 2 diabetes * over 18 * history of foot ulcer exclusion criteria: * history of recent major lower limb surgery (amputation) or revascularisation and orthopaedic reconstruction over the last 3 months * current active foot ulcer * not be able to walk unassisted for 15 meters

Keywords: biomechanics, perfusion, plantar soft tissue, skin microcirculation,
low-dose gh supplementation increases clinical pregnancy rate

Conditions: Infertility

Summary: the objective of this study is to assess whether a low dose of gh supplementation (0.5 iu/day) increases clinical pregnancy rates in women with a history of por who failed to become pregnant in two previous ivf cycles.

the investigators aim to study the impact of a low-dose growth hormone (gh) supplementation in pregnancy rates in poor responders in a prospective, self-controlled study of 64 poor responders to previous ivf cycles who failed to achieve pregnancy and were supplemented with low-doses of gh in a subsequent cycle using the same gonadotropin dose and protocol. our primary endpoint was the clinical pregnancy rate (cpr), considering secondary endpoints the number of retrieved oocytes, embryos, embryo quality and the proportion of cycles with embryo transfer. controlled ovarian hyperstimulation will be performed using a gnrh agonist long protocol from day 21-23 of the menstrual cycle at a dose of 1 mg/ day, using the same schedule and dose as in the previous cycle, so that the only difference between them is the gh supplementation. after confirming pituitary inhibition, the dose of gnrh agonist will be decreased to 0.5 mg/day, and coh will begin with gonadotropins at a dose of 300 ui, subsequently adjusting according to clinical response. human chorionic gonadotropin (hcg) will be administered when follicles reached \> 17 mm in diameter. a dose of 0.5 iu of gh will be administered daily from the first day of the agonist until the day of hcg administration. oocyte retrieval will be performed 36 hours after hcg administration by ultrasound-guided follicle aspiration.

Eligibility criteria:
inclusion criteria: * women with a history of por, defined according to the bologna criteria * absence of pregnancy in at least two previous ivf cycles exclusion criteria: * body mass index ≥ 30 kg/m2 * presence of endocrinopathies * altered karyotype in one or both partners * history of invasive ovarian surgery * history of chronic, autoimmune or metabolic diseases * altered meiosis in testicular biopsy or altered sperm-fish * drug therapy in the male partner * participation, within the previous 6 months, in another clinical trial with medication

Keywords: poor ovarian response ivf growth hormone
the dampness syndrome of chinese medicine cohort study

Conditions: Chronic Disease; Cancer; Dementia Alzheimers; Metabolic Disease; Aging; Alzheimer Disease, Early Onset

Summary: the researchers plain to build a large-scale, longitudinal, prospective cohort characterized by tcm dampness syndrome. with the biobank of this cohort the investigators want to find the causality between tcm dampness syndrome and clinical chronic diseases and a new way to treat clinical disease.

dacos is a national large- scale, longitudinal, multi-center, prospective, cohort study of natural person aged 35 to 75. the baseline survey and the follow-up surveys will be conducted in 5 areas covering the eastern, northern, western, southern and middle parts of china. in this study 100,000 natural person will be regularly followed up for 5 years(visited once a year), with the loss rate ≤15%. three parts will be carried in the form of interview, physical examination and biological sample collection. during the interview, the investigators plan to do some questionnaires to learn participants' demographic characteristics, life style, disease history, healthy condition(eq-5d-5l, sds,), cognition state(ad-8, mmse, moca) and the results of tcm syndrome differentiation(score of dampness syndrome and tcm constitution scale). all biological specimens (including blood, feces, urine, saliva and tongue coating) will be collected and stored in the biological resource center until researchers request their use. with the building up of this cohort, the researchers will analyze the causality between dampness syndrome and specific chronic diseases such as diabetes, coronary heart disease, cancer, dementia and so on.

Eligibility criteria:
inclusion criteria: 1. residents aged 30 to 79, whose residence is consistent with their registered permanent residence location; 2. residents who voluntarily participate in the project, agree to the collection of their biological information, and sign the informed consent form; 3. residents who have no mental illness and other related diseases, and display a normal ability of expression and understanding; exclusion criteria: 1. residents who reject collaboration; 2. residents who allow no follow-up visits.

Keywords: dampness syndrome multi-center study prospective cohort study
etoposide, oxaliplatin and capecitabine in advanced hepatocellular carcinoma (hcc)

Conditions: Hepatocellular Carcinoma

Summary: various cytotoxic agents have been evaluated in advanced hepatocellular carcinoma, but response rates have been low with significant toxicity, most often due to parenchymal liver disease. the three agents etoposide, oxaliplatin and capecitabine each has sparse efficacy as single agents, but the combination may act synergistically with an acceptable toxicity profile.

design: open phase ii study. purpose: response rate for the combination of etoposide, oxaliplatin and capecitabine given every 3 weeks on an outpatient basis. secondary endpoint are safety, time to progression and survival treatment: etoposide are administered intravenously 100 mg/m2 on day 1 and orally 200 mg/m2 on days 2 and 3. capecitabine (xeloda) are administered 1000 mg/m2 twice daily with 12 hours interval for two weeks and one week off oxaliplatin are administered intravenously 100 mg/m2 on day 1 in each cycle as a 2 hours infusion. one cycle is 3 weeks.

Eligibility criteria:
inclusion criteria: * histologically verified intra- or extrahepatic inoperable hepatocellular carcinoma or hyperdense liver lesion at computed tomography and concurrent elevated alpha-feto-protein \> 400 ng/ml * ps 0-2 * age 18-75 * life expectancy \> 12 weeks * normal bone marrow function (neutrophiles \> 1,5 x 109/l and platelets \> 100 x 109/l) * bilirubin \< 2 x unl * transaminases \< 3 x unl * normal renal function, cr-edta clearance \> 50 ml/min * no chemotherapy, radiotherapy or immunotherapy 4 weeks prior to inclusion * no uncontrolled, severe concurrent medical disease * fertile women must have a negative pregnancy test * fertile women must use adequate contraceptives during and 3 months after trial exposure * signed informed consent exclusion criteria: * chemotherapy, radiotherapy or immunotherapy 4 weeks prior to inclusion * experimental therapy \< 8 weeks prior to inclusion * known dpd-deficiency * known neuropathy * uncontrolled, severe concurrent medical disease * prior malignancy during the last 5 years, except for non-melanoma skin cancer and carcinoma in situ cervix uteri.

Keywords: hepatocellular carcinoma etoposide oxaliplatin capecitabine
the study for evaluation of acute phase safety and efficacy of 'pivot bridge' to short-term treat ftr

Conditions: Functional Tricuspid Regurgitation

Summary: evaluation of safety and efficacy of 'pivot bridge' to short-term treat functional tricuspid regurgitation

evaluation of safety and efficacy of 'pivot bridge' to short-term treat functional tri cuspid regurgitation : multi-center, open label, single arm, investigator initiated exploratory pilo t study

Eligibility criteria:
inclusion criteria: * adult males and females aged 20 years or above * patients with clinical symptoms (symptomatic) whose degree of tricuspid regurgitation using echocardiography meets the criteria of severe or higher presented in the tr grade classification table * short-term treatment using a catheter is required (expected to be effective) by a local site heart team including at least one cardiothoracic (cardiovascular) specialist and at least one thoracic surgeon each, and clinical symptoms of nyha class ⅱ or higher person who falls under * in the screening test, a person who can confirm the possibility of reducing tricuspid valve regurgitation by inserting that 'pivot balloon' (clinical trial approval no. 1327), etc.) through the same access path as the 'pivot bridge', a clinical trial medical device * an individual who voluntarily agreed to the participation in the clinical trial and signed the written consent * an individual who is able to understand and comply with the instructions and who can participate in the period before the clinical trial exclusion criteria: * uncontrolled hyperthyroidism * a recent formation of soft blood clot or embolic material * uncorrected coagulopathy * prohibition of anticoagulant agents * those who had experience with anticoagulant use prior to participation in this clinical trial and who were treated with major bleeding (minor bleeding such as nosebleeds that can be hemostasis not applicable) due to anticoagulant use at this time or accompanied by severe anemia requiring hospitalization one with experience * previous insertion of a device such as an implantable cardioverter defibrillator (icd) or a pacemaker * those who is judged to have little possibility of reducing tricuspid valve regurgitation by inserting a balloon-type device (e.g. asd sizing balloon, pivot balloon, etc.) through the same access route as the clinical trial medical device 'pivot bridge' * persons with an anatomical structure that cannot be inserted through the corresponding route

Keywords: ftr rv failure taupnu
sflt1: a biomarker of organ dysfunction in critically-ill patients with covid-19?

Conditions: CORONAVIRUS INFECTIONS

Summary: short description of the protocol intended for the lay public. include a brief statement of the study hypothesis (limit : 5000 characters) the management of critically-ill patients with organ failure due to covid-19 represents a major healthcare burden. while endothelial inflammation has been reported in these patients, the pathophysiological mechanisms remain incompletely elucidated.

extended description of the protocol, including more technical information (as compared to the brief summary) if desired. do not include the entire protocol; do not duplicate information recorded in other data elements, such as eligibility criteria or outcome measures. (limit : 32 000 characters) the soluble fms-like tyrosine kinase 1 (sflt1) is the soluble form of vegf-a receptor 1 (vegfr1). by linking vegf-a with a high affinity, sflt1 blocks the vegf-a / vefr1 axis and impairs endothelial homeostasis. its production increases during inflammation. we hypothesize that sflt1 is upregulated and correlates with endothelial dysfunction and outcomes in critically-ill patients with covid-19.

Eligibility criteria:
inclusion criteria: * patient with documented covid-19 (positive pcr) * hospitalized in university hospital of reims * patient or family who have previously consented exclusion criteria: * patient \<18 yo * patient not insured under the french social security
an integrated analysis of the effectiveness of intravitreal (ivt) aflibercept (eylea) in routine clinical practice based on two large observational studies

Conditions: Macular Degeneration

Summary: the aim of this integrated analysis is to describe the effectiveness of eylea in an integrated pooled analysis using existing individual patient data of two non-interventional studies rainbow and perseus. the primary objective of this integrated analysis is to describe the effectiveness of eylea on the mean change from baseline in visual acuity (va) at 12 months in wet age-related macular degeneration (wamd) treatment naïve patients.


Eligibility criteria:
inclusion criteria: perseus * patients with wet amd treated with eylea (in accordance with the local summary of product characteristics, spc) * documentation of at least one aflibercept (eylea) injection * assessment of at least one visual acuity measurement with available va letter score for the study eye at baseline and at least one post-baseline assessment of visual acuity with available va letter score for the study eye and valid for analysis, i.e. measured at least 5 days after an injection rainbow * patient with a diagnosis of wet amd will be enrolled after the decision for treatment with aflibercept (eylea) has been made * patient who meet the local indication criteria for eylea treatment * at least one bcva after the 1st eylea injection * bcva at baseline * patient with no history of retinal disease * patient not previously treated with any macular laser or any anti-vegf intravitreal injections for the study eye (for fellow eye allowed). * for patients with both eyes treated, the eye firstly treated at initial visit will be considered as study eye. if both eyes are treated during initial visit, the treated eye with worst best-corrected visual acuity (bcva) at m0 will be retained. if the two conditions are similar the study eye is the right eye by convention * patient with 1st injection of eylea from 01 january 2014 until 30 april 2015 will be enrolled exclusion criteria perseus * exclusion criteria as listed in the local spc * scar, fibrosis, or atrophy involving the center of the fovea in the study eye * all patients previously treated with any macular laser or any anti-vegf intravitreal injections for the study eye will additionally be excluded for this integrated analysis * any concomitant therapy with another agent to treat wet amd in the study eye rainbow * patient who does not meet the local indication criteria for eylea treatment. contraindications listed in the smpcs must be taken into account * patient with another retinal disease: diabetic retinopathy, diabetic macular oedema (dme), myopic choroidal neovascularization, retinal vein occlusion (rvo), central serous chorioretinopathy (csc), angioid streaks * patient who has previously been treated with any macular laser (laser and/or visudyne/pdt) or any anti-vegf intravitreal injections for the study eye * patient taking part in an interventional study at the time of enrolment
mechanism of il-10 pathway-mediated regulatory b cell dysfunction in osteoarthritis

Conditions: Osteoarthritis; Knee Arthritis

Summary: our previous work has shown that treg function is impaired in oa patients, but the cause of treg deficiency has not been investigated. since breg has been shown to promote treg differentiation and tissue repair, it is highly likely that the absence of the immunomodulatory effect of breg in oa patients leads to impaired treg differentiation. based on the above data, we hypothesized that breg plays a protective role in the course of oa by regulating t cell composition and promoting treg differentiation through the secretion of anti-inflammatory factor il-10


Eligibility criteria:
inclusion criteria:patients who met the american college of rheumatology diagnostic criteria for oa - exclusion criteria: * patients with trauma, other forms of arthritis such as rheumatoid arthritis, psoriatic arthritis or spondyloarthritis, and other active inflammatory diseases
a survey of darvadstrocel in people with crohn's disease

Conditions: Crohn's Disease

Summary: this study is a survey in japan of darvadstrocel injection used to treat crohn's disease people with complicated anal fistula. the study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study. the main aim of the study is to check for side effects related from darvadstrocel injection and to check if darvadstrocel injection improves symptoms of crohn's disease. during the study, participants with crohn's disease will take darvadstrocel injection according to their clinic's standard practice. the study doctors will check for side effects from darvadstrocel for 36 months.


Eligibility criteria:
inclusion criteria all patients with complex perianal fistulas in crohn's disease who received darvadstrocel will be included. exclusion criteria none
a multifaceted telemedicine-based intervention to improve outcomes of cancer patients admitted to the icu

Conditions: Active Malignancies; Life Threatening Complication of the Malignancy or Its Treatments

Summary: admission to the intensive care unit (icu) is a common event in patients treated for solid tumors or hematologic malignancies. a volume-outcome relationship has been shown in these patients, with a mortality rate decreasing from 70% in low-volume centres to 30-40% in high-volume centres. we hypothesize that providing the low-volume centres with assistance from experts working in high-volume centres for the management of critically-ill cancer patients can bring down mortality to the values seen in high-volume centres. the main objective of this study is to evaluate whether combining three knowledge-transfer methods (videoconference-based forum, educational sessions, and dissemination of published work) increases the survival of cancer patients managed in low-volume centres to the values seen in high-volume centres. the main endpoint is all-cause mortality at hospital discharge.


Eligibility criteria:
inclusion criteria: 1. adult patients (\> 18 years old) 2. active malignancy; 3. icus seeking for an advice must admit fewer than 30 patients with active cancer per year; 4. patients has been urgently admitted in the icu for a life threatening complication of the malignancy or its treatments. exclusion criteria: 1. isolated hiv infection or aids; 2. icu admission complicating scheduled surgery, 3. treatment-limitation decisions at admission; 4. no coverage by the french statutory health insurance system, 5. pregnant or breastfeeding