Kornimate/medical-research-clean huggingface dataset:
chatbot intervention for anxiety and depressive symptoms in young adults

Conditions: Anxiety; Depression

Summary: this clinical trial compares the effects of using an artificial intelligence based therapy chatbot and a self-help book to lower anxiety and depressive symptoms. the therapy chatbot (named fido) is an application delivering support for mental health via a conversation-like interface in a highly inflected language (polish). the team will recruit young people (aged 18-35) who currently struggle with anxiety and/or depression. the participants will use the chatbot or self-help materials for two weeks. then, the researchers will check if using the chatbot or the book improved several aspects of mental health and the quality of life. moreover, they will compare the groups for any differences in outcomes.

the primary objective of this randomized controlled trial is to evaluate the effectiveness of a chatbot-delivered cognitive-behavioural intervention on anxiety and depressive symptoms (and their correlates, such as quality of life or feelings of loneliness) in a subclinical sample of about 80 participants. the intervention results are compared to an active control intervention with popular self-help materials. secondary objectives include the assessment and analysis of the human-chatbot therapeutic bond and general user experience. the study uses a 2 x 3 mixed factorial design with two intervention arms (fido chatbot vs self-help book) and three time points (t1: just prior to the intervention, t2: immediately after the intervention, t3: at a follow-up one month after the previous measurement). the primary intervention lasts two weeks. all primary and secondary outcomes are assessed using self-administered online questionnaires in polish. each primary outcome measure is analyzed using a 2 (arms) x 2 (time points) anova models with t1-t2 comparisons to test for the intervention effect and t1-t3 comparisons to check the stability of the intervention effect. additional analyzes utilize standard nhst calculations and procedures (such as t-tests and correlation coefficients) alongside the conventional ⍺=.05 level. similarly to the previous research in this area, no blinding is used. participants are informed about different conditions, but the research hypotheses are masked.

Eligibility criteria:
inclusion criteria: * declaring at least mild depressive or anxiety symptoms by achieving a total score of at least 16 points on center for epidemiologic studies depression scale revised or at least 50 points on penn state worry questionnaire * being able to visit the study site in poznań (poland) to complete all measurements exclusion criteria: * undergoing psychotherapy, coaching or psychopharmacological treatment * being diagnosed with a neurological disorder

Keywords: anxiety depression quality of life loneliness
correlation between imatinib trough concentration and efficacy in advanced gist patients with different genotypes

Conditions: Gastrointestinal Stromal Tumor, Malignant

Summary: imatinib (im) has significantly enhanced the prognosis of patients (pts) with advanced gastrointestinal stromal tumors (gists). the clinical outcomes may correlate with im exposure. however, the efficacy threshold, particularly based on different primary kit mutant, remains undefined. the objective of this study is to establish the efficacy threshold of imatinib (im) plasma trough concentration (cmin) at steady-state in chinese patients with advanced gist, additionally to define subgroup thresholds based on various primary kit mutations.

gastrointestinal stromal tumors (gists) are the most common mesenchymal tumors of the gastrointestinal tract. the majority of gist are driven by activating mutuations of kit (60-70%) or platelet-derived growth factor receptor alpha (pdgfra, 10-15%), in which kit exon 11 mutation (52-58%) and kit exon 9 mutation (6-9%) are the most common types of kit mutations. patients with different activating kit mutations have different sensitivity to imatinib therapy. in the first-line therapy, patients with kit exon 11 mutation receiving imatinib with standard dose of 400mg/d has the best therapeutic effect. patients with kit exon 9 mutation have poor sensitivity to the standard dose of imatinib, while higher doses can lead to better outcomes. the clinical outcomes may correlate with im exposure. however, the efficacy threshold of imatinib in chinese patients with advanced gist remains unclear. the investigators aim to establish the efficacy threshold of imatinib plasma trough concentration (cmin) at steady-state in chinese patients with advanced gist, additionally to define subgroup thresholds based on various primary kit mutations.

Eligibility criteria:
inclusion criteria: * histologically confirmed metastatic or recurrent gist * aged 18 or older * treated with imatinib as first-line therapy * had imatinib cmin measurement at steady state(at least one month after treatment) ≥2 times under long-term maintenance dose of regular medication * eastern cooperative oncology group performance status (ecog ps) of 0 to 2 exclusion criteria: * poor appliance * important treatment data missing * combined use of cyp enzyme inducers or inhibitors, such as rifampicin, carbamazepine, ketoconazole, ritonavir, rifamequal
study of retinal oxygenation in central retinal vein occlusion

Conditions: Retinal Vein Occlusion

Summary: the purpose of the study is to test if oxygen saturation in retinal vessels is correlated with clinical parameters, such as visual acuity, central retinal thickness and presence of neovascularization. retinal oximetry is performed with fundus camera based oximeters. the study will not entail change in treatment of the disease.


Eligibility criteria:
inclusion criteria: * suspected central retinal vein occlusion. * informed consent for participation. * no treatment before the first oximetry measurement. exclusion criteria: * history of other retinal disease. glaucoma and diabetes without retinopathy are not exclusion criteria but should be registered. * history of cardiovascular or respiratory diseases that can be expected to influence systemic or retinal oxygen saturation. examples: known copd or carotid stenosis. subjects with high blood pressure will not be excluded but blood pressure should be registered. * poor quality images will be excluded based on the images themselves. therefore, grading of cataract or other media opacities is not strictly necessary for the purpose of the study.
fluid balance during surgery for ovarian cancer

Conditions: Ovarian Neoplasm; Fluid Therapy

Summary: extensive tumour debulking challenges both surgeon and anaesthesiologist but promotes survival in late-stage ovarian cancer patients. little is known about the intraoperative fluid balance and its impact on morbidity and mortality.


Eligibility criteria:
inclusion criteria: * patients scheduled for cytoreductive surgery in ovarian cancer exclusion criteria: * age \< 18 years * unability to give consent
cohort study of the clinical course of macular diseases in japanese

Conditions: Macular Disease

Summary: recent clinical introduction of anti-vascular endothelial growth factor agents may change the clinical course of macular diseases, including age-related macular degeneration (amd), polypoidal choroidal vasculopathy (pcv), retinal angiomatous proliferation (rap), central serous chorioretinopathy (csc), myopic choroidal neovascularization (cnv), retinal vein occlusion (rvo), diabetic macular edema (dme), and so forth. patients with such macular diseases are registered and and are followed up for 5 years with appropriate treatment for each patient. by the analysis of the correlation between initial examinations and final visual acuity, factors associated with good visual prognosis will be elucidated.


Eligibility criteria:
inclusion criteria: * patients who visit department of ophthalmology kyoto university hospital with macular diseases. * patients who are agreed with the participation of this study. exclusion criteria: * none
follow-up of patients with covid-19.

Conditions: Patient Admitted to Intensive Care Unit for COVID-19

Summary: some patients admitted to intensive care for a severe form of covid-19 could have respiratory, cardiac, renal and neurological sequelae in the medium or long term. the results of this research will allow an improvement in the understanding and management of patients in the medium and long term.


Eligibility criteria:
inclusion criteria: * patient admitted to intensive care unit for covid-19 * adult patient ≥ 18 years old * subject having expressed his non-opposition to the research * subject affiliated to a social health insurance protection scheme or beneficiary of such a scheme exclusion criteria: * subject under safeguard of justice * patient under guardianship or curatorship
the relationship between cadaveric allograft skin and hla-sensitivity in burn patients

Conditions: Burns

Summary: the purpose of this research study is to look at how the body's immune system reacts to temporary skin grafts from deceased donors.

some burns will heal best with the use of temporary skin grafts from cadavers before covering the burns with grafts of the patient's own skin. this is the usual care for these types of burn injuries recommended by burn surgeons. this skin is applied in the operating room and removed after several days. during that time, the body's immune system will make antibodies to the skin. normally, these antibodies are harmless. however, extra antibodies can make it difficult to find donors for transplants. the results of this study will be used to better understand how to treat a subset of burn patients with very severe burns in a way that allows them to receive tissue transplants (e.g. face transplants, hand transplants).

Eligibility criteria:
inclusion criteria: * adults aged 18 years or older * burns of deep partial thickness or full thickness depth totaling less than or equal to 10% total body surface area. * injury requiring staged reconstruction with allograft skin (experimental group) * injury requiring reconstruction with autograft skin (i.e. no cadaver skin; control group) exclusion criteria: * burns exceeding 10% total body surface area. * pre-existing allosensitization at time of injury * blood or blood product transfusion requirement * pregnancy at the time of injury or during study period * history of solid organ transplant during study period * history of autoimmune disorder (systemic lupus erythematosus, etc.) * history of mechanical circulatory support (extracorporeal membrane oxygenation, ventricular assist device, total artificial heart) during study period
a snapshot audit of traumatic pelvic ring injuries

Conditions: Pelvic Trauma; Pelvic Fracture; Fragility Fractures of the Pelvis (FFP)

Summary: multicenter, snapshot cohort studies or audits have the ability to gather large patient numbers in short time periods from many healthcare systems with different resources or practices of care concerning one specific surgical condition. this type of studies allows exploration of differences in patient populations and management across the sampled cohort to identify areas of practice variability that may result in apparent differences in outcome. as such, whilst not providing true evidence of efficacy or the impact of a single variable on overall outcome, these studies can be hypothesis-generating and identify areas warranting further study in future randomized controlled trials (1). snapshots also shed light on the real world practice, rather than the presumed or guideline suggested patient care (2). traumatic pelvic ring injuries (tpri) represent a broad spectrum of trauma-associated pathologies with a distinct bimodal age distribution in patients admitted through the emergency departments of all acute care hospitals. in younger patients, this type of injury is often associated with high-energy trauma, hemodynamic instability, high mortality and morbidity rates (3-6). in the elderly population, pelvic fractures result from low energy trauma mechanisms (e.g. ground level fall) and can affect the long-term independency and life quality of geriatric patients (7). there is substantial variation in the management of pelvic ring injuries among pelvic trauma surgeons; these variations include but are not limited to the timing of definitive fixation, the indications and protocols of conservative treatment, and the appropriate osteosynthesis of the anterior and/or posterior pelvic fractures (8). this 'estes snapshot audit' -a prospective observational cohort study- has a dual purpose. firstly, as an epidemiological study, it aims to report the burden of injury in specific hospitals, distributed widely throughout europe. secondly, this study aims to demonstrate current strategies for both, younger (after high-energy trauma) and geriatric patients (after low-energy trauma) employed to assess and treat these patients. these twin aims will serve to provide a 'snapshot' of current medical practice, but will also be hypothesis-generating while providing a rich source of patient-level data to allow further analysis of particular clinical questions. the acquired study data can be subsequently evaluated and compared to patient data of established pelvic trauma registries across europe.


Eligibility criteria:
inclusion criteria: * adult patients (≥18 years of age) admitted for traumatic pelvic ring injuries (ao/ffp-classification). exclusion criteria: * concomitant acetabular fractures
tvt worldwide registry

Conditions: Stress Urinary Incontinence

Summary: the objective of this observational study is to obtain long -term clinical and patient reported outcomes on the use of the gynecare family of tvt (tension-free vaginal tape) systems in women with stress urinary incontinence.

sites may include patients with either the gynecare tvt secur system, gynecare tvt system, or the gynecare tvt obturator system

Eligibility criteria:
inclusion criteria: * women diagnosed with sui who are suitable candidates for a tvt system, as according the relevant instructions for use (ifu).
safety and efficacy of i-020502 in meshed skin autografting

Conditions: Burns

Summary: this is a phase ii, multi-centre, controlled study comparing the safety and tolerability on wound healing following an application of i-020502 in a concentration of 1μg/ml tg-pdgf.ab versus staples applied in the same patient to burn areas requiring autologous meshed skin grafting.


Eligibility criteria:
inclusion criteria: 1. written informed consent by the patient or his/her legal representative. 2. male or female, aged ≥ 18 years. 3. female with childbearing potential with a negative pregnancy test within 3 day prior to surgery (screening). 4. patients with burn wound(s) between ≥ 5 % and ≤ 50 % tbsa. 5. patients with a contiguous deep partial thickness/full thickness wound(s) of two comparable sites either contiguous or separate in the same location (e.g. leg) each sized between 1% and 2% tbsa but not more than 400 cm2. 6. patients who are willing to comply with treatment applications and instructions by the protocol. exclusion criteria: 1. females who are pregnant or breast-feeding. 2. patients with known or suspected allergies to any of the components of the wound healing gel i-020502 (e.g. hypersensitivity to bovine proteins). 3. digits, head, genitalia, palms of hands, soles of feet, and face are excluded as test sites. 4. electrical and/or chemical burns. 5. patients that are judged to have significant pulmonary compromise. 6. transcutaneous tissue oxygenation \< 90%. 7. clinically significant infections at wound sites. 8. clinically significant systemic infections. 9. suspicion or presence of active systemic or local cancer or tumor of any kind. 10. patients with known immunodeficiency disorders, either congenital or acquired. 11. patients with vascular or skin disorders that directly affect the designated wound site. 12. patients with diabetes mellitus. 13. patients with chronic malnourishment. 14. chronic treatment with immunosuppressive drugs or systemic corticosteroids within the last 2 months prior to surgery. 15. any other acute or chronic concurrent medical conditions that in the investigator's opinion are a contraindication to skin mesh grafting and study participation. 16. participation in another investigational study within 30 days prior to surgery, for investigational devices, or within the last three months for investigational drugs related to wound healing.

Keywords: burn, meshed skin graft, pdgf deep partial thickness or full thickness burns
study of talabostat in advanced melanoma

Conditions: Melanoma; Skin Cancer

Summary: the purpose of this study is to assess the antitumor activity and safety of talabostat in patients with metastatic melanoma.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed melanoma that is metastatic (unresectable stage iv per ajcc 2002) * patients with measurable disease defined as at least one measurable index lesion with clearly defined margins * ecog performance status of 0, 1, or 2 * expected survival ≥12 weeks * written informed consent exclusion criteria: * more than 1 prior chemotherapy or biotherapy regimen for stage iv melanoma * radiation therapy to \>50% of the bone marrow. patients must not have had prior radiotherapy to index lesions unless they have clearly progressive disease in this site or there is measurable disease outside the area of prior radiation. * clinically significant laboratory abnormalities * cns metastases * any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix * the need for chronic (i.e., \>7 days) oral or intravenous corticosteroid therapy * any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol * patients who are within 30 days of chemotherapy, radiation therapy, immunotherapy, or other investigational medication for melanoma. patients must have recovered from all of the side effects of treatment in order to be enrolled. * pregnant or lactating women.
phosphorylation of erk1/2 in patients with parkinson's disease

Conditions: Parkinson Disease

Summary: levodopa-induced dyskinesia severely limits the use of levodopa in parkinson's disease and constitutes a debilitating complication of dopaminergic treatment in late stage. among several neurobiological mechanisms identified so far, the investigators have established in experimental models the key role of d1 receptor hypersensitivity and a"ras-erk" signalling pathway. as the very same dopamine receptor machinery and the ras-erk pathway are present in blood lymphocytes, the investigators wish to test the hypothesis that the level of erk phosphorylation in lymphocytes is a biomarker of levodopa-induced dyskinesia in parkinson's disease. the study will be performed in dyskinetic levodopa-treated patients and non-parkinson's disease controls. blood sampling "off" and "on" levodopa treatment (1 hour post-dose), as well as clinical data collection will be done during a scheduled pre-op work-up (deep brain stimulation). subsequently, suspended lymphocytes from blood samples will be immunolabelled using an anti-perk antibody and mean fluorescence intensity and percent of labelled lymphocytes will be assessed by flow cytometry. additionally, plasma and urine samples will be collected "on" et "off" for dosage of dopamine. the motor effect of levodopa will be assessed through uprsiii rating scale and eye movement (saccades) speed by non-invasive oculometric recordings.


Eligibility criteria:
inclusion criteria: * consecutive eligible pd in- and outpatients selected at the university hospital of bordeaux. * non-demented patients (dsm iv) who are able to give their informed consent and who are affiliated to the social security. * controls: subjects without known neurological disorder, non-demented, able to give their informed consent and affiliated to the social security. exclusion criteria: * patients: atypical or secondary parkinson disease. * previous or current cancer or malignant haemopathy. * known auto-immune disease. * anti-neoplastic or immuno-modulator treatment (particularly corticosteroids). immuno-deficient subjects. * acute viral infection (within 2 weeks after resolving). statin drug intake. demented subject (dsmiv). * controls: same criteria as above plus any neurological disease.
non-invasive ventilation in patients with interstitial lung disease - a feasibility study

Conditions: Noninvasive Ventilation; Lung Diseases, Interstitial

Summary: the efficiency of non-invasive ventilation (niv) in hypercapnic patients with chronic obstructive pulmonary disease during pulmonary rehabilitation has been shown in numerous studies. there is only a limited number of therapeutic options for patients with severely progressed interstitial lung disease (ild). the question whether chronic hypercapnic ild-patients are able to profit from nocturnal niv and thus increase their performance in physical training has been left unknown. therefore, this study aims to evaluate the feasibility of the initialization of a niv for hypercapnic ild-patients during pulmonary rehabilitation.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of interstitial lung disease * hypercapnia defined as carbon dioxide partial pressure ≥45 mmhg (at rest, night or activity) * already existing but not sufficient and regular use of non-invasive ventilation (≤3h/24h) * patients consent to participate in this trial exclusion criteria: * acute pulmonary insufficiency (ph\<7.35) * acute, clinically relevant heart disease * already existing and sufficient use of non-invasive ventilation (≥3h/24h) * body-mass-index\>30 * obstructive sleep apnea * intolerance to perform non-invasive ventilation * acute infection
maternal diet, body mass index trajectories and cardiometabolic risk in early childhood

Conditions: Cardiometabolic Risk; Growth; Childhood Obesity

Summary: this study focused on evaluating the association between adherence to the mediterranean diet during pregnancy and offspring longitudinal body mass index trajectories and cardiometabolic risk in early-childhood. this study is part of a secondary data analysis of the inma (infancia y medio ambiente-(environment and childhood)) project.


Eligibility criteria:
inclusion criteria: * to be resident in one of the study areas * to be at least 16 years old * to have a singleton pregnancy * to wish to deliver in the reference hospital exclusion criteria: * to not be fluent in spanish or other regional languages. * to have followed a programme of assisted reproduction
safety of subcutaneous methylnaltrexone for opioid-induced constipation in patients with advanced illness

Conditions: Opioid-Induced Constipation

Summary: this is an open-label, multicenter extension of study 3200k1-4000-ww that will evaluate the safety of methylnaltrexone. this drug will be administered by subcutaneous injection and will be tested in late stage, advanced illness patients who have constipation caused by opioid pain relievers. this study will last 3 months.


Eligibility criteria:
inclusion criteria: * has completed study 3200k1-4000-ww, including 2 weeks of therapy and completion of all post baseline efficacy, safety, and health outcomes assessments. * is receiving opioids on a regular schedule, not just as needed to control pain. * likely to continue to need treatment of oic for the duration of participation in the study. exclusion criteria: * has a suspected mechanical gastrointestinal obstruction, fecal impaction, or clinically important active diverticular disease as determined by the investigator. * currently using an opioid antagonist or partial antagonist. * has any other clinically important abnormalities such that risk to patient of participation outweighs the potential benefit of therapy as determined by the investigator

Keywords: opioid-induced constipation