Kornimate/medical-research-clean huggingface dataset:
the efficacy and safety of tdcs in patients with mild to moderate major depressive disorder

Conditions: Depression

Summary: this study evaluated the effectiveness and safety of improving depressive symptoms by applying tdcs for 6 weeks to patients with mild to moderate depression.

patients received tdcs for 30 minutes with an intensity of 1.5 to 2 ma. tdcs was applied over the left (anode) and right (cathode) dorsolateral prefrontal cortex (dlpfc) 5\~7 times a week and they were evaluated every 2weeks through questionnaires.

Eligibility criteria:
inclusion criteria: * has a diagnosis of a major depressive disorder as confirmed by the dsm-v and mini (without psychotic features) * patients with a k-bdi-ii score of 14 or more and 28 or less * in the case of patients who have previously administered antidepressants, antipsychotics, and anticonvulsants for at least 1 week, patients with sufficient drug treatment periods of at least 5 times the drug half-life. exclusion criteria: * patients diagnosed with axis i disorders other than major depressive disorder * patients diagnosed with other depressive disorders besides major depressive disorder * patients who have attempted suicide within 6 months of screening * patients who are considered to have problems with eeg and dc stimulation electrode attachment due to scalp deformity, inflammatory reaction, or other dermatological problems * patients judged to have other reasons for prohibition of use of tdcs medical devices * patients currently taking antidepressants
comparison of radiographic fusion rate and clinical outcome of alif and xlif performed with either recombinant human bone morphogenetic protein-2 or vivigen®

Conditions: Spondylosis; Spondylolisthesis; Degenerative Disc Disease

Summary: the aim of this study is to prospectively investigate the potential for bony fusion of vivigen® bone graft substitute in comparison to rhbmp-2 in monosegmental alif procedure l5/s1 and in monosegmental xlif procedure l4/5

the investigator hypothesize that - the bony fusion rate on a 12-month ct scan (or earlier at 6-month ct scan) is less than 10% lower in the intervention group compared to the bony fusion rate in the control group for patients included in the study, all follow-up is recorded, with regards to radiological and clinical outcome. follow up will be evaluated after 14 days, 6 weeks, 6 and 12 months. last follow up will be 1 year after surgery.

Eligibility criteria:
inclusion criteria: patients who have an indication for a monosegmental alif procedure on the l5/s1 segment or a monosegmental xlif procedure on l4/5 (both alif and xlif procedure with or without an additional pedicular stabilisation), e.g., treating conditions such as spondylosis, spondylolisthesis and degenerative disc disorders with back and/or leg pain * patients must be 18 - 70 years of age * patients must have understood and signed the study information and the informed consent form * patients are willing and able to complete scheduled follow-up evaluations / questionnaires as described in the informed consent exclusion criteria: * patients under 18 years and over 70 years of age * patients with tumour / spine trauma / known bone disease / parkinson's disease and similar cns disorders / diseases or injuries of the peripheral nerves * other procedures or segment than mentioned in the inclusion citeriaadditional planed spine surgeries after index surgery * current smoking * pregnant or breastfeeding patients (or patient planning a pregnancy within one year after surgery) * insufficient language skills in german * inability to give informed consent * refusal to participate in the study, unsigned study consent * participation in another interventional study within the 30 days preceding and during the present study

Keywords: vivigen radiographic fusion rate anterior lumbar interbody fusion recombinant human bone morphogenetic protein-2 spondylosis spondylolisthesis degenerative disc disease extreme lateral interbody fusion
efficacy of aliskiren in the treatment of diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: to assess the efficacy of oral aliskiren as a therapy for diabetic macular edema


Eligibility criteria:
inclusion criteria: * type 1 or type 2 diabetes * diabetic macular edema exclusion criteria: * recent intra-ocular surgery in the study eye (e.g., cataract surgery in the last 6 months) * recent laser photocoagulation in the study eye * recent treatment with avastin, lucentis, or intravitreal corticosteroids in the study eye other protocol-defined inclusion/exclusion criteria applied

Keywords: diabetes macular edema aliskiren diabetic retinopathy diabetes mellitus type 1 diabetes mellitus type 2
systematic assessment of vascular risk

Conditions: Peripheral Vascular Disease

Summary: it is hypothesized that patients with vascular disease are undertreated for modifiable risk factors, leading to increased morbidity and mortality in this population. the objective of this study is to develop a comprehensive database that will demonstrate the current adequacy of risk factor management in this high risk population, and that will provide needed guidance for future treatment options.


Eligibility criteria:
inclusion criteria: all patients who attend the vascular surgery clinic at toronto general hospital, st. michael's hospital, and st. joseph's health centre who have pad, cerebrovascular disease (cbvd), or aneurysms will be eligible for this study. patients who are currently enrolled in other clinical studies are eligible for this study; however proper adherence to the other study will take precedence over of the current proposal.
progressive gait training after first-time deep venous thrombosis: clinical effectiveness and involved mecanisms (the dvt-cph rct)

Conditions: Deep Vein Thrombosis (DVT)

Summary: the dvt-cph rct aims to investigate: 1. if progressive gait training in combination with standard care is superior to standard care on quality of life in patients with first time lower extremity deep venous thrombosis (clinical effectiveness part). 2. the association between progressive gait training and disease progression, late complications such as post throbotic syndrome, and severity of venous thromboembolism conditions in patients with first time lower extremity deep venous thrombosis (mechanistic part).

the dvt-cph rct will be qualified by a preceeding feasibility trial (nct05761119) that aims to investigate: (1) the feasibility of the intervention and trial procedures using quantitative outcomes, and (2) patient experiences with and attititudes towards the intervention using qualitative interviews. simultaneously with the rct, a prospective cohort study (the dvt-cph cohort study; nct05789108) will investigate and characterize acutely admitted patients with deep venous thrombosis via inflammatory, anti-inflammatory, immunological and ageing biomarkers to gain a better understanding of options about prevention and treatment of long-term complications. patients enrolled in the feasibility trial as well as in the dvt-cph rct can also enroll in the dvt-cph cohort study to utilize study synergy and enhance research information gain.

Eligibility criteria:
inclusion criteria: * 18 years or above * first time lower extremity dvt * hospitalized at the emergency department * can cooperate cognitively and physically (patient reported) exclusion criteria: * patients without a danish social security number * terminal patients * patients who do not understand or speak danish

Keywords: physical activity
surveillance of efficacy and safety of drug pritor in patients with arterial hypertension, who do not tolerate ace inhibitor treatment

Conditions: Hypertension

Summary: surveillance of efficacy and safety of drug pritor in patients with arterial hypertension, who do not tolerate ace inhibitor treatment


Eligibility criteria:
inclusion criteria: * patients over 18 years of age * arterial hypertension (sbp \< 160 mmhg and dbp \< 100 mmhg) * patients, who do not tolerate ace inhibitors (must be documented in the official ambulant documentation) inclusion criteria for the control arm (treated by acei): * patients over 18 years of age * arterial hypertension (sbp \< 160 mmhg and dbp \< 100 mmhg) * patients, who tolerate acei treatment exclusion criteria: * cholestasis, severe hepatic insufficiency * allergy to telmisartan * gravidity or lactation exclusion criteria for the arm of patient treated by acei: * cholestasis, severe hepatic insufficiency * allergy to acei * gravidity or lactation

Keywords: arterial hypertension
biochemical diagnostics of mild traumatic brain injury (tbi) and concussion in children and adolescents

Conditions: Brain Injuries, Traumatic

Summary: the study will enroll children and adolescents (0 - 17 years) suspected of having concussion or mild traumatic brain injury (tbi). samples of urine and saliva will be collected from the patients as well as from corresponding age- and gender-adjusted healthy controls.

the collected samples will be alienated to the sponsor who will perform biochemical studies to identify and measure from the samples relative level of the brain injury-specific biomarkers.

Eligibility criteria:
inclusion criteria: * the subject is suspected of having an isolated mild tbi (glasgow coma score 13 - 15) * no more that 6 hours elapsed from the incident of injury at the first sampling * the patient is conscious * informed consent received from the legal guardian, and the subject him-/herself when literate and capable of understanding study measures exclusion criteria: * more than 6 hours elapsed from the injury, or unknown time of trauma * multi-trauma patient * history of head injury, seizures or stroke within three preceding months * chronic neurodegenerative, metabolic or autoimmune disease * known existing neurological condition
mesalamine 4 g sachet for the induction of remission in active, mild to moderate ulcerative colitis (uc)

Conditions: Ulcerative Colitis

Summary: the purpose of this trial is to investigate the efficacy of mesalamine for the induction of clinical and endoscopic remission in subjects with active, mild to moderate uc. subject will receive 4 g extended release granules (sachet) once daily.


Eligibility criteria:
inclusion criteria: * male or female subjects aged 18 to 75 years * mild to moderate uc exclusion criteria: * disease limited to proctitis \<15 cm * short bowel syndrome * prior colon resection surgery * history of severe/fulminant uc * evidence of other forms of inflammatory bowel disease * infectious disease (including human immunodeficiency virus \[hiv\], hepatitis b virus \[hbv\], or hepatitis c virus \[hcv\]) * intolerant or allergic to aspirin or salicylate derivatives * use of rectal formulations (5-aminosalicylic acid \[5-asa\], steroids) within ≤7 days * women who are pregnant or nursing * history or known malignancy * history of bleeding disorders, active gastric or active duodenal ulcers, autoimmune diseases, or mental/emotional disorders, that would interfere with their participation in the trial
study assessing the effectiveness of a cardiac web-based elearning platform

Conditions: Coronary Artery Disease

Summary: in the trial cardiac patients will be provided with unrestricted access to the web-based elearing platform for a one-month period.

patients participating in the trial will be provided with a cardiac web-based elearning platform for one month during study period. the medical content of the packages will be gathered from a multidisciplinary input of both medics (e.g. cardiologists) and paramedics (e.g. psychologists). e-learning packages type i: videos with information from caregivers. in these videos, medics and paramedics are interviewed to highlight the etiology, pathophysiology and treatment of coronary artery disease; the associated comorbidities and the ways to prevent recurrence. e-learning packages type ii: videos in which patients are interviewed. patients can help each other to adhere to their treatment plan, by sharing stories from their own experience about their illness and the rehabilitation afterwards. short clips of maximum 2 minutes will be provided to study participants.

Eligibility criteria:
inclusion criteria: * patients suffering from coronary artery disease for which they are treated conservatively, with a percutaneous coronary intervention or with coronary artery bypass grafting exclusion criteria: * patients with dementia or cognitive impairment not being able to sufficiently understand the e-learning packages content * (foreign) patients unable to speak dutch, thereby not being able to understand the content of the e-learning packages * patients with advanced visual and/or auditory impairments, hindering them to adequately understand the e-earning packages * patients participating in another trial during the pilot study period * patients refusing to provide signed consent

Keywords: e-learning coronary artery disease telerehabilitation e-health
mirror trial - follow-up management of peripheral arterial intervention with clopidogrel

Conditions: Peripheral Vascular Diseases

Summary: the mirror study is a randomized, double-blinded mono-centre trial the access the periinterventinal and postinterventional administration of clopidogrel in patients with peripheral vascular disease.

clopidogrel is approved for secondary prevention of atherosclerosis in patients with peripheral vascular disease. currently there are no data about the amount of platelet activation during peripheral arterial intervention, the effect of clopidogrel on platelet adhesion and its clinical impact. patients with chronic peripheral arterial disease receive placebo or clopidogrel before the intervention and for 6 months in follow-up. platelet activation, the effect on macro-and microcirculation will be assessed as well as clinical endpoints.

Eligibility criteria:
inclusion criteria: * peripheral arterial disease which requires intervention exclusion criteria: * patient already on coumadin or clopidogrel * acute onset of pvd symptoms * patient requiring an operation * contraindication to aspirin and clopidogrel

Keywords: peripheral arterial intervention atherosclerosis platelets age above 18
effect of bm-mscs in dcd kidney transplantation

Conditions: Kidney Transplantation; Acute Kidney Tubular Necrosis

Summary: this study is designed to determine the efficacy and safety of allogeneic bone marrow-derived mesenchymal stem cells in kidney transplantation from chinese donation after citizen's death (dcd). a pair uremia patients receiving kidney grafts from a same donor are randomized into two groups: mscs group and control group. besides routine induction therapy (atg or basiliximab) and maintenance immunosuppressive drugs (low-dose tacrolimus + mpa + prednisone), patients in mscs group are administered mscs treatment (1\*10\^6/kg). allogeneic bone marrow-derived mscs (1\*10\^6/kg) are given intravenously at day 0 (post renal reperfusion during surgery), day 7, day 14 and day 21. the renal allograft function, rejection, patient/graft survival and severe adverse events within 12 months post-transplant are monitored.


Eligibility criteria:
inclusion criteria: 1. primary kidney transplantation 2. receiving induction therapy and combined immunosuppressive regimens (cnis + mpa + steroids) 3. patient is willing and capable of giving written informed consent for study participation and able to participate in the study for 12 months exclusion criteria: 1. secondary kidney transplantation 2. combined or multi-organ transplantation 3. women who are pregnant, intend to become pregnant in the next 1 years, breastfeeding, or have a positive pregnancy test on enrollment or prior to study medication administration 4. panel reactive antibody (pra)\>20% 5. cdc crossmatch is positive 6. donors or recipients are known hepatitis c antibody-positive or polymerase chain reaction (pcr) positive for hepatitis c 7. donors or recipients are known hepatitis b surface antigen-positive or pcr positive for hepatitis b 8. donors or recipients are known human immunodeficiency virus (hiv) infection 9. patients with active infection 10. recipients with a history of substance abuse (drugs or alcohol) within the past 6 months, or psychotic disorders that are not capable with adequate study follow-up. 11. patients with severe cardiovascular dysfunction 12. wbc\<3\*10\^9/l or rbc \<5g/dl 13. highly allergic constitution or having severe history of allergies. 14. patients with active peptic ulcer disease, chronic diarrhea, or gastrointestinal problem affect absorption 15. patients with a history of cancer within the last 5 years 16. prisoner or patients compulsorily detained (involuntarily incarcerated) for treatment or either a psychiatric or physical (e.g. infectious disease) illness

Keywords: kidney transplantation mesenchymal stem cell donation after citizen's death ischemia reperfusion injury renal function recovery
efficacy of a prepackaged cleansing cloth and standardized cleansing protocol for catheter care at reducing cauti rates

Conditions: Catheter-Associated Urinary Tract Infection

Summary: superiority study evaluating the efficacy of a prepackaged cleansing cloth and standardizing cleansing protocol vs. previous standard-of-care for catheter care and maintenance.

a superiority study evaluating the efficacy of a complete cleansing system composed of 5 prepackaged, moistened cloths with a standardized cleaning method compared to the previous standard-of-care for catheter care and maintenance. the primary objective is to investigate if the implementation of prepackaged cleansing cloths with a standardized cleaning protocol for all indwelling urinary catheter (iuc) care and maintenance provides a reduction in cautis. the readycleanse complete cleansing system will replace the previous standard-of-care. the readycleanse intervention will be compared to the previous standard-of-care retrospectively.

Eligibility criteria:
inclusion criteria: * any adult patient who requires an iuc to be placed during admission to one of the four study hospitals exclusion criteria: * patients \<18 years of age * patients whose entire hospital stay occurs in: pediatric unit, psychiatric unit, labor \& delivery or postpartum units, and emergency room
infliximab plus methotrexate for the treatment of rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to evaluate the safety and effectiveness of infliximab (an anti-tnf chimeric monoclonal antibody \[ca2\]) in patients with active rheumatoid arthritis, despite methotrexate treatment.

this is a placebo-controlled, double-blinded, randomized clinical study to evaluate the safety and effectiveness of infliximab in patients with active rheumatoid arthritis, despite methotrexate treatment. infliximab is an anti-tnf chimeric monoclonal antibody (ca2). the primary measures of effectiveness include the change from baseline in american college of rheumatology (acr20) response at week 30, and the change in the modified van der heijde sharp score. the acr20 responder index a composite of clinical, laboratory, and functional measures and the van der heijde-sharp (vdh-s) scoring method is a method of rating structural damage in patients.. patients will be treated with either infliximab or matching placebo.

Eligibility criteria:
inclusion criteria: * patients with active rheumatoid arthritis despite treatment with methotrexate * diagnosed with rheumatoid arthritis at least 6 months prior to screening * having active disease at the time of screening and pre-infusion as defined by having at least 6 or more swollen joints and 6 or more tender joints * using methotrexate for at least 3 months prior to study enrollment exclusion criteria: * patients having any systemic inflammatory condition * having lyme disease or a rheumatic disease other than rheumatoid arthritis * who have used disease-modifying antirheumatic drugs (dmards) other than methotrexate within 4 weeks prior to screening * who have used corticosteroids within 4 weeks prior to screening * having received previous administration of infliximab

Keywords: rheumatoid arthritis infliximab methotrexate
a study to assess the effectiveness and safety of vismodegib (erivedge®) in participants with advanced basal cell carcinoma (bcc)

Conditions: Basal Cell Carcinoma

Summary: this prospective, observational, cohort study is designed to assess the effectiveness and safety outcomes of vismodegib and to assess actual day-to-day disease and participant management by the physician.


Eligibility criteria:
inclusion criteria: * bcc that meets one of the study's pre-specified cohort definitions * physician's decision to treat participant with vismodegib as per local label * participant who has not participated in a clinical trial within 90 days prior to study enrollment, with the exception of participants who meet the criteria for cohort 2 (no gorlin syndrome participants with prior hpi exposure) exclusion criteria: * female participants are excluded if they are pregnant or if they plan to become pregnant during treatment or within 2 years after end of treatment * male participants with female partners of childbearing potential are excluded if they plan to impregnate their partner during treatment or within 2 months after end of treatment
validation study of the "cornell assessment pediatric delirium" (capd)" scale in italian language

Conditions: Delirium

Summary: 70 children (based on the inclusion and exclusion criteria described above) admitted in picu will be daily assessed by two nurses (inter-evaluator agreement) using the italian version of capd scale administered twice at a distance of 2 minutes (intra-evaluator agreement).

the psychometric validation study will take place in the picu of the hospital of padua. capd translation and cultural adaptation was developed within the pediatric cardiac surgery intensive care unit of the federico ii polyclinic. in this study we aim to perform the psychometric validation. 70 children (based on the inclusion and exclusion criteria described above) admitted in picu will be daily assessed by two nurses (inter-evaluator agreement) using the italian version of capd scale administered twice at a distance of 2 minutes (intra-evaluator agreement). the score will be recorded in a data collection card, all the cards will be collected and then analyzed.

Eligibility criteria:
inclusion criteria: * picu admission * comfort behavioral score \> 11 exclusion criteria: * use of neuromuscular blocking agents at the moment of capd evaluation * comfort behavioral score \< 11

Keywords: delirium monitoring
follow-up of symptomless inguinal and ventral hernias

Conditions: Hernia, Inguinal; Hernia, Ventral; Laparoscopy

Summary: the orifices of all inguinal and ventral (including spigelian) hernias were carefully recorded at the beginning of laparoscopy (n=201) of other reason (cholecystectomy, fundoplication) in 2003-5. the patients with occult hernias (n=43) were followed-up 15 years to find out what percentage of hernias would become symptomatic.

this was a prospective laparoscopic study of 201 consecutive adult patients operated in 2003-5. there were 133 females and 68 males with a mean age 53 ± 14 years. the index laparoscopic operation included 104 cholecystectomies, 55 fundoplications, 36 diagnostic, 5 appendectomies and one insertion of peritoneal catheter. a careful clinical examination of the groin and ventral region was performed on everybody and all patients with clinical hernias were excluded. laparoscopic exploration of the inguinal region was considered safe and did not greatly increase the operative time. all patients were informed that hernial orifices would be explored during laparoscopy, and a written consent was asked prior to surgery. permission to repair large hernias (\> 1 cm) was also obtained before laparoscopy. the patients were followed-up 15 years to find out, what percentage of occult, symptomless inguinal and ventral hernias were later operated because of harmfull symptoms.

Eligibility criteria:
inclusion criteria: * occult inguinal or ventral hernia diagnosed in laparoscopic surgery exclusion criteria: * clinically diagnosed inguinal or ventral hernia

Keywords: inguinal hernia ventral hernia laparoscopic diagnosis