Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of photodynamic therapy for unresectable cholangiocarcinoma

Conditions: Cholangiocarcinoma

Summary: the aim of this study is to investigate the efficacy of photodynamic therapy (pdt) in increasing the survival time, decreasing cholestasis and improving health-related quality of life (hrqol) by comparing pdt puls stents versus stents alone in patients with unresectable cholangiocarcinoma,and to assess the safety of pdt by observing the complications after the procedure.

cholangiocarcinoma (cca) is difficult to diagnose due to its anatomic location, clinical course, and lack of definitive diagnostic criteria. it is often clinically silent with symptoms developing only in advanced disease. surgical resection is the recommended curative intervention with only a minority of patients (10-20%) having potentially resectable tumors at time of diagnosis. endoscopic palliative therapy in cca entails the relief of obstructive jaundice through transpapillary or percutaneous insertion of plastic or metal biliary stents. although biliary decompression provides relief of cholangitis and improvement in quality of life, it does not improve survival. photodynamic therapy (pdt) in conjunction with biliary stenting may improve bile duct patency by local obliteration of malignant tissue through the cytotoxic effects of reactive oxygen species. several studies suggest pdt plus biliary stent placement may prolong survival (range of 360-630 days), reduce cholangitis, and improve the quality of life of patients with advanced disease. the aim of this study is to determine the effectiveness and safety of pdt with biliary stenting compared to biliary stenting alone in the palliative treatment of unresectable cca in china.

Eligibility criteria:
inclusion criteria: * obtention of a written informed consent. * patient over 18. * patient with histologically proved cholangiocarcinoma ; histologic diagnosis must be proved by biliary brushing, bile cytology, endobiliary biopsy under spyglass, or by eus-fna. * patient with karnofsky score ≥ 50 % * patient capable of fill in the quality of life questionnaire exclusion criteria: * no written informed consent. * patients under or already treated by radiotherapy or chemotherapy treatment for cholangiocarcinoma. * patients with porphyria or hypersensibility to porphyrins. * pregnant, parturient or breastfeeding women. * patient under 18.

Keywords: biliary duct carcinoma photodynamic therapy
chemotherapy induced peripheral neuropathy (cipn) and lymphoma longitudinal follow-up and prognostic factors

Conditions: Lymphoma; Peripheral Neuropathy

Summary: vincristine-induced peripheral neuropathy, which is commonly a sensorimotor neuropathy, remains a major complication of lymphoma patients treated with r-chop. the investigators propose a clinical, electrophysiological and biological follow up of patients treated by vincristine for lymphoma to determine the factors implied in vipn occurrence.

patients with lymphoma will be evaluated before chemotherapy (t1), after 4 cycles (t2), at the end of the chemotherapy treatment (if more than 4 cycles) (t3) and 6 month after the end of chemotherapy (t4).

Eligibility criteria:
inclusion criteria: * diagnosis of indolent or aggressive b/t nhl confirmed by biopsy and requiring chemotherapy after pcr decision including vincristine, rchop/chop protocol or choep * accept to participate in the study * age \> 18 year * able and willing to provide informed consent * affiliated to a social security system exclusion criteria: * life-threatening emergency requiring chemotherapy in extreme urgency * neuro-meningeal damage at diagnosis * protected person (under guardianship or curators) * person under court protection * pregnant or breastfeeding woman * persons deprived of liberty by judicial or administrative decision * persons under forced psychiatric care * persons admitted to a health or social institution for purposes other than research * persons unable to express their consent

Keywords: chemotherapy induced peripheral neuropathy nerve conduction study vincristine lymphoma
safety and efficacy of escalating doses of leo 43204 applied once daily for two consecutive days on approximately 250 cm2 on trunk and extremities in subjects with actinic keratosis

Conditions: Actinic Keratosis

Summary: part 1: to identify maximum tolerated dose (mtd) levels of leo 43204 after once daily treatment for two consecutive days part 2: to evaluate the efficacy of leo 43204 in two doses after once daily treatment for two consecutive days compared to vehicle


Eligibility criteria:
inclusion criteria: * part 1: subjects with 5 to 20 clinically typical, visible and discrete aks on the arm * part 2: subjects with 5 to 20 clinically typical, visible and discrete aks on the extremities or trunk exclusion criteria: * location of the treatment area * within 5 cm of an incompletely healed wound * within 5 cm of a suspected basal cell carcinoma (bcc) or squamous cell carcinoma (scc) * prior treatment with ingenol mebutate gel on the treatment area * lesions in the treatment areas that have: * atypical clinical appearance (e.g., hypertrophic, hyperkeratotic or cutaneous horns) and/or * recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions)
endoscopic procedures of children in the normalization process of covid-19 pandemic

Conditions: Covid19

Summary: endoscopic methods are frequently used in the diagnosis of gastrointestinal system pathologies in children.

endoscopic methods are frequently used in the diagnosis of gastrointestinal system pathologies in children. in the investigators' center, which is a pandemic hospital, only emergency endoscopic procedures were performed during the pandemic period, while emergency and elective endoscopic procedures are performed in accordance with the recommendations of the ministry of health during the normalization process. staff and patients in endoscopy units are at risk for covid-19 infection by inhalation of airborne droplets, conjunctival contact, and potential fecal-oral contamination. in order to reduce the risk of contamination, according to the recommendations of the european gastrointestinal endoscopy association (esge); proper cleaning of endoscopic devices, non-reuse of disposable devices, cleaning the endoscopy hall with a disinfectant solution, use of gowns ffp2 / 3 masks and jewelry during the procedure, handwashing with soap and hand disinfection is recommended before and after each procedure. in addition, it is recommended that patients who have undergone endoscopic procedures should be followed up or communicated on days 7 and 14 in terms of the development of covid-19 infection. it is recommended that patients should be questioned in terms of covid-19 infection before endoscopy, but rapid antigen testing and serology are not routinely recommended. molecular diagnosis (pcr, amplification) tests are recommended for patients at risk for covid-19 infection.

Eligibility criteria:
inclusion criteria: * children between the ages of 1-18 who will undergo endoscopic procedures * patients who can be questioned about covid-19 infection before and on the 7th and 14th days after the procedure * patients who volunteered to study exclusion criteria: * under 1 year and over 18 years of age * patients who could not be questioned about covid-19 infection before the procedure and on the 7th and 14th days after the procedure * patients who not volunteered to study

Keywords: endoscopy colonoscopy children covid -19 pandemic
autologous cell therapy after stroke

Conditions: Stroke

Summary: this study will examine the safety of two different cellular therapies in the treatment of stroke.

stroke remains a leading cause of death and disability. a limited number of therapies, such as intravenous tissue plasminogen activator, have been approved to interrupt stroke in the early hours after symptom onset. many patients are not able to benefit from these therapies, however, and so a need exists for development of new interventions to reduce disability after stroke. this study will be an early step towards this, and will examine the safety of two cell types, mononuclear cells and marrow stromal cells. in each case, the cells will be autologous, specifically being derived from the subject's own bone marrow.

Eligibility criteria:
inclusion criteria: * ischemic stroke that is supratentorial in location and \< 72 hours old between stroke onset and bone marrow aspiration * no major pre-stroke disability * nih stroke scale score of 7-24 * able to undergo bedside bone marrow aspiration * age 18-85 years, inclusive * reasonable likelihood of receiving standard physical, occupational and speech rehabilitation therapy exclusion criteria: * no major active hematological, immunological, or oncological diagnoses * pregnancy * lactating mothers * at least 24 hours time of any thrombolytic therapy and time of bone marrow aspiration * allergy to penicillin or to fetal bovine serum * active, major co-existent neurological or psychiatric disease * infection with hiv, hepatitis b or c, or syphilis * any diagnosis that makes survival to 90 days post-stroke unlikely * participation in an experimental therapeutic clinical trial in the prior three months

Keywords: stroke cell therapy repair autologous
different microlenses array for controlling myopia progression in children and adolescents

Conditions: Myopia Progressing

Summary: this study aims to evaluate the effectiveness of lenses with different defocused microlens array in controlling the progression of myopia in children and adolescents, and to explore the feasibility of effective defocus microlens design, and apply personalized defocus frame lenses for myopia prevention and control.


Eligibility criteria:
inclusion criteria: 1. age: 6-14 years old; 2. after using 1% cyclohexanone hydrochloride eye drops (saifeijie) for ciliary muscle paralysis, binocular spherical power were within -0.50d\~-4.00d, binocular cylinder power ≤ 1.50d, the anisometropia is less than 1.50d, and the best corrected visual acuity was above 5.0; 3. within 30 days, the myopia prevention and control methods such as multifocal glasses, orthokeratology, defocusing flexible glasses, progressive glasses, atropine eye drops, red light and acupuncture and moxibustion treatment were not used; 4. the subject has a willingness to receive treatment and an informed consent form is signed by their legal guardian. exclusion criteria: 1. diagnosed constant strabismus; 2. diagnosed pathological myopia; 3. other congenital eye diseases; 4. researchers believe that the patients have other reasons that are not suitable for inclusion in the project.
imaging of intracranial and extracranial arterial atherosclerotic plaques using different field strength mris

Conditions: High Resolution Vessel Wall Imaging; Intracranial Atherosclerotic Stenosis, ICAS; Arteriosclerosis

Summary: atherosclerotic stenosis of the carotid and intracranial arteries is one of the leading causes of ischemic cerebrovascular events worldwide. among these, intracranial atherosclerotic stenosis has an incidence rate of up to 46.6% in patients with ischemic stroke or transient ischemic attack (tia) in china. the continuous advancement of high-resolution vascular wall imaging (hr-vwi) technology has enabled multi-dimensional imaging of the arterial walls of both intracranial and extracranial vessels. by suppressing intravascular flow, this technique allows clear visualization of the vascular wall morphology and signal characteristics, as well as the identification of plaque composition and assessment of vulnerable plaque features. however, due to the smaller size of intracranial atherosclerotic plaques, the image quality and effectiveness of current 3.0t high-resolution magnetic resonance imaging (mri) are influenced by hardware and software limitations, as well as imaging parameters, making it difficult to accurately perform qualitative and quantitative analysis of intracranial and extracranial plaques. the advent of ultra-high field 5.0t mri overcomes the limitations of 3.0t mri in imaging, significantly improving the signal-to-noise ratio and allowing for clearer visualization of the signal characteristics of the arteria.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years; * moderate to severe intracranial or extracranial arterial stenosis (stenosis degree: 50% to 99%, confirmed by cta, mra, or dsa); * written informed consent signed by the patient or their legal representative. exclusion criteria: * non-atherosclerotic intracranial arterial stenosis, such as dissection or moyamoya disease; * contraindications to mri, such as claustrophobia or presence of a cardiac pacemaker; * allergy to gadolinium-based contrast agents; * poor mri image quality preventing analysis; * abnormal liver or kidney function; * history of any prior endovascular treatment; * presence of implants posing potential safety risks in 5.0t mri, such as non-removable metallic dental prostheses, stents, or other metallic implants.
tdcs to enhance cognitive training in multiple sclerosis

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: expected results: an improvement in cognitive performance in both groups, boosted in the experimental arm and not confined to general frontal-cognitive abilities; potential changes would be reflected also by neurophysiological measures and in qol. discussion: investigators hope to provide additional treatment tools for rrms subjects, with a medium-long term efficacy and an extensive effect. this exploratory pilot study will help to set the rationale for future studies, providing preliminary data useful for selecting the best primary outcome and for calculating a better sample size.


Eligibility criteria:
inclusion criteria: * subjects with clinically definite diagnosis of relapsing remitting ms (rrms); * male or female subjects, 18 to 65 years old; * expanded disability status scale (edss) score ranging from 0 to 5.5 (included); * predominant deficits in either attention/information processing; * fluent italian speakers; * normal or corrected-to-normal vision; * ability to understand the purpose and risk of the study and provide signed informed consent. exclusion criteria: * ms patients in different phase of the disease (as primary/secondary progressive ms; benign ms) or clinical isolated syndrome (cis) patients; * exclusive cognitive impairment in different domains (e.g., memory); * ct/neuromodulation program ongoing or in the preceding 6 months; * clinical exacerbations, neuroradiological activity of the disease, modification of edss score and disease modifying treatments/steroids during the last 3 months preceding study enrolment; * significant medical disorders or other major systemic, psychiatric, neurological disorders or alcohol/substance abuse that could interfere with cognitive functioning; * antidepressant/psychoactive drugs in the past 3 months; * contraindications to tdcs (intracranial metallic plates, implanted devices, skin disease, superficial injury and fracture or infraction of skull in the stimulation area, epilepsy, pregnancy, etc).

Keywords: multiple sclerosis relapsing remitting multiple sclerosis cognitive training cognitive rehabilitation cognitive remediation neuromodulation transcranial direct current stimulation
comparison of early outcomes of minimally invasive surgery for oesophageal replacement versus open surgery in children

Conditions: Post-Op Complication; Anastomosis; Complications

Summary: a comparative prospective study of postoperative between minimally invasive and open surgery complications for esophageal replacement in children

esophageal replacement in childhood is indicated in esophageal atresia patients with long-gap defects or following complications of primary esophageal anastomosis, as well as in patients with trauma and scarring to the esophagus following caustic ingestion. it is widely accepted that the ideal esophageal replacement is one that resembles the function of the native esophagus with minimal deterioration over time. several techniques of esophageal replacement have been developed. these have focused mainly on the use of native tissues (including the stomach, jejunum, and colon) as conduits (1), attempts to use a synthetic prosthesis have been largely unsuccessful. in an attempt to reduce the trauma and morbidity associated with laparotomy and thoracotomy incisions, minimally invasive techniques are increasingly used. (2-4). meta-analyses of adult esophagectomy for the treatment of esophageal cancer support the use of minimally invasive surgery (5) however, equivalent comparative studies in the pediatric population are lacking. as such, it is unclear whether minimally esophageal replacement is as safe as the open procedure in children. the present study aims to address this question by comparing the postoperative outcomes of children who underwent minimally invasive versus open esophageal replacement procedures at single-center and multicenter levels.

Eligibility criteria:
inclusion criteria: all children undergoing oesophageal replacement aged one to 18 years. due to 1. long gap esophageal atresia 2. caustic ingestion 3. congenital esophageal stenosis or strictures exclusion criteria: * patient who underwent previous esophageal replacement operations.
effect of probiotics in reducing infections and allergies in young children during the complementary feeding period

Conditions: Days Absent From Day Care; Respiratory Tract Infections; Gastrointestinal Infections; Allergy

Summary: the aim of the intervention is to examine the effect of the bacterial strain bb-12, provided for 6 mo, on the prevalence of infections and allergic manifestations in small children, and how bb-12 affects the immune system, the gastrointestinal tract and the microbiota. children are enrolled during 2 winter seasons.


Eligibility criteria:
inclusion criteria: * 9 - 12 1/2 month at intervention start * start in daycare 4 +/- 2 weeks after intervention start * single born exclusion criteria: * children born before 37th gestational week * children with a birth weight \< 2500 g * children suffering from severe chronic illness * children receiving regular medication * children who have received antibiotics within a month before intervention start * children whose parents do not speak danish

Keywords: infections allergy immune function microbiota infant
freiburg tips registry

Conditions: Liver Cirrhosis; Portal Hypertension; Non-Cirrhotic Portal Hypertension; Budd Chiari Syndrome; Portal Vein Thrombosis; Portal Systemic Shunt

Summary: patients with clinically significant portal hypertension allocated to implantation of a transjugular intrahepatic portosystemic shunt (tips) at the department of medicine ii of the university medical center freiburg, germany will be offered to participate in this prospective observational trial. clinical and laboratory as well as outcome parameters will be assessed before and within the first 12 months after tips implantation following a regular follow-up schedule with clinical visits at the university medical center freiburg. during follow-up visits, serum/plasma samples and peripheral blood mononuclear cells (pbmc) are collected and stored in a associated biobank.

patients with clinically significant cirrhotic and non-cirrhotic portal hypertension who are allocated to implantation of a transjugular intrahepatic portosystemic shunt (tips) can be included in this observational study. further patients who have been treated between 01/01/2005 and the start of the prospective part of this study (01/01/2023) will be included retrospectively in this registry. patients who are allocated to tips implantation will be recruited the day before tips implantation. detailled patient characteristics, epidemiologic, clinical, imaging and laboratory parameters will be assessed and included in an electronic database. further, interventional data of tips implantation will be included in the database. apart from these data, patients will be asked to participate in biobank sampling including serum/plasma and peripheral blood mononuclear cells (pbmc) samples from the peripheral veins and from the liver and portal vein that will be taken during tips implantation. all patients recruited in this registry will be followed-up for at least 12 months with regular visits 3, 6 and 12 months after tips implantation. outcome parameters including development of post-tips hepatic encephalopathy, acute- on chronic liver failure (aclf), infections, recurrence of clinically significant portal hypertension, need for tips revision and death and liver transplantation will be assessed.

Eligibility criteria:
inclusion criteria: * patients allocated to tips implantation due to clinically significant cirrhotic and non-cirrhotic portal hypertension exclusion criteria: * withdrawal of written informed consent

Keywords: liver cirhosis transjugular intrahepatic portosystemic shunt non-cirrhotic portal hypertension prognosis outcome
ft825/ono-8250, an off-the-shelf, her2 car-t, with or without monoclonal antibodies in advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: this is a phase 1 study designed to evaluate the safety, tolerability, and antitumor activity of ft825 (also known as ono-8250) with or without monoclonal antibody therapy following chemotherapy in participants with advanced human epidermal growth factor receptor 2 (her2)-positive or other advanced solid tumors. the study will consist of a dose-escalation stage, followed by an expansion stage to further evaluate the safety and activity of ft825 in indication-specific cohorts.


Eligibility criteria:
inclusion criteria: * histopathological or cytologically confirmed locally advanced or metastatic cancer that meets protocol-defined criteria * disease that is not amenable to curative therapy, with prior therapies defined by specific tumor types * contraceptive use by women and men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies * eastern cooperative oncology group (ecog) performance status 0 or 1 * presence of measurable disease by recist, v1.1 assessed within 28 days prior to start of first study intervention * anticipated life expectancy of at least 3 months exclusion criteria: * females who are pregnant or breastfeeding * evidence of inadequate organ function * clinically significant cardiovascular disease * known active central nervous system (cns) involvement by malignancy * non-malignant cns disease such as stroke, epilepsy, cns vasculitis, or neurodegenerative disease or receipt of medications for these conditions within 2 years prior to study enrollment * active bacterial, fungal, or viral infections * prior receipt of chimeric antigen receptor (car) t-cell therapy, other cellular therapy, or a fate investigational human induced pluripotent stem cell (ipsc) product * history of (non-infectious) interstitial lung disease (ild)/pneumonitis that required steroids, current ild/pneumonitis, or suspected ild/pneumonitis that cannot be ruled out based on imaging at screening * any history of grade ≥3 immune-related ae or grade ≥2 eye toxicity attributed to prior cancer immunotherapy, other than endocrinopathy managed with replacement therapy or asymptomatic elevation of serum amylase or lipase * active or history of autoimmune disease or immune deficiency * receipt of an allograft organ transplant