Kornimate/medical-research-clean huggingface dataset:
standard immunosuppressive therapy combined with romiplostim n01 as first-line treatment for severe aplastic anemia

Conditions: Aplastic Anemia; TPO Receptor Agonists

Summary: this prospective, single center, single-arm study aims to evaluate the efficacy and safety of anti-human t lymphocyte porcine immunoglobulin (p-alg) in combination with cyclosporine and romiplostim in treating severe aplastic anemia (saa). it will include 48 patients with newly diagnosed saa.


Eligibility criteria:
inclusion criteria: * age ≥ 12 years * diagnosis of severe or very severe aplastic anemia * patients are unconditionally or unacceptable undergoing allogeneic hematopoietic stem cell transplantation * ecog performance status ≤2 * willing and able to comply with the requirements for this study and written informed consent. exclusion criteria: * received \> 4 weeks of tpo-ra drug before treatment * received \> 4 weeks of immunosuppressive therapy before treatment * history of thromboembolic disease * intolerance to romiplostim n01 or cyclosporine * allergy to alg * presence of uncontrolled active infection * presence of uncontrolled hypertension (≥140/90mmhg), diabetes mellitus (fasting blood glucose≥ 7.0 mmol/l or random blood glucose ≥ 11.1 mmol/l) * abnormal liver and kidney function: aspartate transaminase (ast) or alanine transaminase (alt) \> 3 uln, creatinine ≥ 2.5 uln * history of chemoradiotherapy for malignant solid tumors * history of other systemic serious illnesses * females who are pregnant/lactating or need pregnancy * patients considered to be ineligible for the study by the investigator for reasons other than the above

Keywords: severe aplastic anemia romiplostim n01
the paediatric virtual autopsy trial

Conditions: Stillbirth; Newborn Death; Sudden Infant Death

Summary: in light of declining autopsy rates around the world, post-mortem mr imaging is a promising alternative to conventional autopsy in the investigation of infant death. a major drawback of this non-invasive autopsy approach is the fact that histopathological and microbiological examination of the tissue is not possible. the objective of this prospective study is to compare the performance of minimally invasive, virtual autopsy, including ct-guided biopsy, with conventional autopsy procedures in a paediatric population. foetuses, newborns, infants and children that are referred for autopsy at three different institutions associated with the university of zurich will be eligible for recruitment. all bodies will be examined with a commercial ct and a 3 tesla mri scanner, and investigators will be blinded to the results of conventional autopsy. after cross-sectional imaging, ct-guided tissue sampling will be performed by a multifunctional robotic system (virtobot) allowing for automated post-mortem biopsies. virtual autopsy results will be classified with regards to the likely final diagnosis and major pathological findings and compared to the results of conventional autopsy, which remains the diagnostic gold standard. this interdisciplinary study will determine whether virtual autopsy will narrow the gap in information between non-invasive and traditional autopsy procedures.


Eligibility criteria:
inclusion criteria: * stillborn infants ≥ 16 0/7 weeks of gestational age (ga) * live born infants ≥ 16 0/7 weeks ga until adolescents up to 16 years of age, who died of natural- and non-natural cause (trauma, homicide, suicide and intoxication). exclusion criteria: * deceased infants who are donors of organs * lack of parental consent

Keywords: autopsy minimally invasive foetuses newborns children adolescents
adversity and its association with the development and expression of rheumatic diseases

Conditions: RhA - Rheumatoid Arthritis

Summary: epidemiological evidence shows that adverse experiences, particularly, but not exclusively in childhood, are predictors of poor long-term health outcomes and certain social domains. in the field of rheumatic diseases, traumatic events, not only in childhood, have been associated with hospitalization, chronic pain, inflammation, worse outcomes, severity of the disease, and mortality. some mechanisms proposed to explain the association between the experience of adversity and the development of chronic diseases include an impact on the physiology of immune system cells, gene expression due to dna modification, and cellular senescence. with this background, the investigators wonder if, for patients with rheumatoid arthritis, the presence of adversity understood as a history of violence in childhood and abuse due to suffering from rheumatoid arthritis is associated with markers of cellular senescence and with the severity of illness.

to answer this question, the investigators proposed conducting a study on outpatients diagnosed with rheumatoid arthritis treated at the incmnsz. patients who agree to participate will be asked to answer some questionnaires to report their perception of child abuse and abuse derived from suffering from rheumatoid arthritis, disease activity, disability, quality of life, anxiety, stress, depression, and resilience. additionally, a peripheral blood sample will be taken to evaluate cellular senescence through cd27, cd28, and cd57 expression, the relative expression of the p16ink4a gene in cd3+ lymphocytes, hla-dr, cd25, and cd69, and telomere length. finally, the expression of the severity of the disease will be determined.

Eligibility criteria:
inclusion criteria: * patients with a rheumatoid arthritis diagnosis, according to their primary rheumatologist who agrees to participate exclusion criteria: * patients with a not confirmed rheumatoid arthritis diagnosis

Keywords: adversity rheumatic diseases
assessment of continuous measurement of transcutaneous co2 for evaluation of alveolar dead space during exercise

Conditions: Pulmonary Disease, Chronic Obstructive; Lung Diseases, Interstitial; Chronic Heart Failure; Pulmonary Arterial Hypertension; Hyperventilation Syndrome; Healthy

Summary: the study aim is to monitor, during exercise tests carried out in various conditions, the alveolar dead space, by means of continuous transcutaneous measurement of pt co2, which would be used as a surrogate for arterial paco2. validity of this measurement needs to be assessed against arterial sampling (either arterial, or arterialized capillary), especially with regards to the lag time required by the co2 diffusion from the arterial compartment (paco2) to the cutaneous one (ptco2), in particular when rapid changes of co2 might be induced by exercise. the evaluation will be done in 2 different settings: * intensive care patients, equipped, for their routine clinical care, with an arterial line; this allows for a precise timed comparison between paco2 and ptco2 readouts; * routine exercise test, where blood gas evaluation is done essentially by means of arterialized earlobe capillary sampling. following assessment of validity of the measurement (and the lag time paco2-ptco2 which might be necessary to introduce as a correction), evolution of dead space during excise test will be tested in different conditions: healthy subjects, patients with chronic obstructive pulmonary disease (copd), chronic heart failure (chf), hyperventilation, pulmonary artery hypertension (pah), or interstitial lung disease (ild)


Eligibility criteria:
inclusion criteria: * written and informed consent, and assent where required. * either: patients in intensive care, conscious and in stable hemodynamic condition, who are already equipped with an arterial line for blood gas analysis (as required by the routine practice in intensive care; no arterial line shall be inserted for the purpose of this study) (part a1) or patients/subjects scheduled for routine cardio-pulmonary exercise testing. among these, the following patients will be included: copd, pah, healthy subjects, hyperventilation, chronic cardiac failure, interstitial lung diseases (ild) (part a2 and part b) exclusion criteria: * non-french speaking patients/subjects * unstable hemodynamics * local cutaneous lesion or infection * arterial disease such as fistula * women with the following condition: pregnancy, breast feeding * persons deprived of liberty (according to article l1121-5 to l1121-8 of the french public health code)

Keywords: transcutaneous ptco2 dead space exercise test
life-2023-02 esophagogastric variceal bleeding

Conditions: Acute Esophageal Variceal Hemorrhage

Summary: study on the efficacy of the growth inhibitors after endoscopic treatment of acute esophagogastric variceal bleeding

participants with acute esophagogastric variceal bleeding in 5 days and under stable status will be included in this study. all the patients will take ctp test to confirm the blood flow status of the portal vein before endoscopic treatment. after that they will be randomly divided into two groups: a. accept growth inhibitors after the endoscopic treatment for 5 days; b. no growth inhibitor will be applied after the treatment.

Eligibility criteria:
inclusion criteria: * acute esophagogastric bleeding with hepatic cirhosis; * stable status (no active bleeding) exclusion criteria: * endoscopic test limitation; * previous acute esophagogastric bleeding treatment history; * icu; * pregnant; * immunity disabled;
efficacy of percutaneous injection of triamcinolone in the treatment of mammillary fistula

Conditions: Mammillary Fistula

Summary: the investigators recently proposed a new hypothesis on the pathogenesis of mammillary fistulae (mf) suggesting that occlusion of hair follicles by keratinous plugging may relevantly contribute to the development of mf. the investigators believe that the pathogenesis of mf mimics the behaviour of hidradenitis suppurative, as both clinical entities manifest themselves as a chronic, suppurative and recurrent inflammatory process. this new proposal has led to the present suggestion of a therapeutic alternative for mf.

to compare the results from a prospective observational database with two groups of patients: 1. patients with mf treated by percutaneous drainage and saline solution. 2. patients with mf treated by percutaneous drainage and saline solution plus percutaneous triamcinolone. these patients are treated following usual clinical practice in our department. all the procedures are made through an ultrasound-guided way. during the follow-up of these cases (clinical and with ultrasound) resolution rate will be registered by the same investigator. the follow-up will be at least 6 months.

Eligibility criteria:
inclusion criteria: * mammillary fistula * older than 18 years * patient acceptation to the recruitment exclusion criteria: * diabetes mellitus * arterial hypertension * immunodepression * peptic ulcer * chronic bowel inflammatory diseases

Keywords: mammillary fistula triamcinolone ultrasound management percutaneous treatment
the effect of tdcs in patients with moderate to severe major depressive disorder

Conditions: Major Depressive Disorder

Summary: study type: interventional study design: allocation: randomized endpoint classification: safety/efficacy study intervention model: parallel assignment masking: double blind (subject, caregiver, investigator, outcomes assessor) primary purpose: treatment

patients will be randomized to receive either real or sham-tdcs as well as anti-depressant drugs. tdcs will be applied over the left (anode) and right (cathode) dorsolateral prefrontal cortex (dlpfc). patients will visit the hospital to get tdcs administrations 5 days a week for 2 weeks. they will be evaluated every 2 weeks.

Eligibility criteria:
inclusion criteria: * has a diagnosis of a major depressive disorder as confirmed by the scid-iv and mini (without psychotic features) * greater than 22 points of montgomery-asberg depression rating scale * aged 19 to 65. * has provided informed consent exclusion criteria: * has other mental disorders diagnosed by axis-i, except major depressive disorder (however, subject who is diagnosed as both major depressive disorder as well as anxiety disorder can participate the study.) * history of suicidal attempt in the last 6 months * diagnosed with bipolar or psychotic major depressive disorder * diagnosed with other depressive disorders: dysthymic disorder, and depressive disorders that are not elsewhere classified. * has hypersensitivity to sertraline ingredients * a score of 5 or greater for the question #10 in madrs * diagnosed with closed angle glaucoma or has a history of glaucoma. * history of participation in other clinical trials within 30days. * a major and/or unstable medical or neurologic illness * currently taking substances that contain sertraline, mono amine oxidase inhibitor, or pimozide * pregnant or has a positive pregnancy serum test.

Keywords: major depressive disorder tdcs mdd transcranial direct current stimulation
safety and efficacy of duo extended set: combined glucose sensor and infusion set.

Conditions: Type 1 Diabetes

Summary: the study will follow subjects for 28 days while using an duo extended infusion set combined with glucose sensor. the objective is to evaluate saftey and efficacy of the set in adult patient with type 1 diabetes.


Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of type 1 diabetes for at least one year 2. using a minimed™ 670g or 640g insulin pump with guardian sensor 3. age 18 to 80 years 4. hemoglobin a1c level less than or equal to 10% 5. not currently known to be pregnant, nor planning pregnancy during the study. 6. willingness to follow the protocol and sign the informed consent exclusion criteria: 1. a known medical condition that in the judgment of the investigator might interfere with the completion of the protocol. 2. pregnant or lactating females 3. subject has glycosylated hemoglobin (hba1c) \> 10 % at time of screening.
a study to validate comparability of an infrared thermographic camera versus oral, forehead, and ear thermometers when determining body temperature in adult participants

Conditions: Temperature Change, Body

Summary: the primary objective of this study is to determine if the infrared cameras, inc (ici) fmx 400 infrared (ir) class 1 infrared thermal camera (irt) system is comparable to oral, forehead, and ear thermometers for determining human body temperature.


Eligibility criteria:
inclusion criteria: 1. participants must be able to provide opt-out consent. 2. participants must agree to have temperature recorded noninvasively using an infrared thermal camera (irt) class 1 device, oral thermometer, forehead thermometer, and ear thermometer. exclusion criteria: 1. participants who opt out of participating; ie, participants who do not agree to have temperature recorded noninvasively using an irt class 1 device, oral thermometer, forehead thermometer, and ear thermometer. 2. participants who are not able to understand that their temperature will be recorded, or who are otherwise unwilling to participate.

Keywords: infrared thermal camera irt
folfirinox in metastatic high grade gastroenteropancreatic neuroendocrine carcinomas

Conditions: Gastro-enteropancreatic Neuroendocrine Tumor; Pancreatic Cancer; Neuroendocrine Carcinomas of Pancreas; Islet Cell Carcinoma

Summary: the purpose of this study is evaluate the efficacy and safety of folfirinox in patients with gastroenteropancreatic high-grade neuroendocrine carcinomas. this is a prospective phase ii open-label trial, stratifying gastroenteropancreatic high grade neuroendocrine carcinomas participants equally into two cohorts (first-line versus beyond first-line).


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed neuroendocrine carcinoma of the gastrointestinal (gi) tract. potential participants with unknown origin for the neuroendocrine carcinoma in which a gastroenteropancreatic origin is suspected (per pathologist or investigator discretion) will be eligible for the study. * tumors must have a ki-67 index greater than 20% and/or \>20 mitotic figures/10 high-power fields. * must have metastatic disease. * must measurable disease, as defined by response evaluation criteria in solid tumors (recist) 1.1. * any line of treatment (first line versus beyond first line). * age \>18 years. * life expectancy of greater than 12 weeks. * eastern cooperative oncology group (ecog) performance status of 0, 1 or 2. * must have adequate organ and marrow function. * ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * have had chemotherapy or radiotherapy within 3 weeks prior to entering the study. * receiving any other investigational agents. * untreated brain or meningeal metastases. * prior treatment with 5-fluorouracil (5-fu), irinotecan or oxaliplatin. * pre-treatment peripheral neuropathy greater than grade 1 per the ctcae, version 4.0. * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * a secondary primary cancer (excluding baso/squamous cell carcinoma of skin) within 1 year. * active viral hepatitis or autoimmune hepatitis. the work-up to confirm active hepatitis or autoimmune hepatitis will only be done if clinical suspicion based on investigator discretion. * potential participants with childbearing potential who are not willing to use adequate contraception precautions during the study and for 3 months after stopping study chemotherapy.

Keywords: gastroenteropancreatic neuroendocrine carcinomas (gep-necs) metastatic high grade pancreas neuroendocrine carcinoma of gastrointestinal tract
a study of e6005 in japanese patients with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: the safety and pharmacokinetics of topical application with e6005 ointment compared to vehicle will be evaluated in japanese male patients with atopic dermatitis. additionally, the efficacy of topical application with e6005 ointment will be explored in japanese male patients with atopic dermatitis.


Eligibility criteria:
inclusion criteria; * japanese adult male patients with a confirmed diagnosis of atopic dermatitis according to "guidelines for management of atopic dermatitis" by the japanese dermatological association. * patients with evaluable typical eczema on the back (posterior trunk). * patients whose age is equal to or more than 20 and less than 65 at the time of treatment and who can provide written informed consent. exclusion criteria; * patients complicated with eye symptoms (e.g., cataract, retinal detachment), kaposi varicelliform eruption, and molluscum contagiosum or impetigo contagiosa. * patients who had or have a severe allergy such as anaphylactic shock, anaphylactic reaction and anaphylactoid reaction or allergy/hypersensitivity to e6005 or any of their excipients. * patients who received any concomitant ethical drugs or any phototherapies within 14 days prior to baseline. subjects are allowed to use external steroids and tacrolimus ointment 8 or more days before baseline and bland emollients free of medicinal properties (e.g., white petrolatum) throughout the study period. * patients with any infection that required hospitalization or intravenous/oral treatment with antibiotic/antiviral/antifungal drug(s) within 28 days prior to baseline. * patients who had or have any malignancy, lymphoma, leukemia, or lymphoproliferative disorders, which dose not include skin cancers (e.g., squamous cell carcinoma or basal cell cancer) that were completely removed and have not metastasized for 5 years.

Keywords: dermatitis atopic
superior hypogastric plexus blockade in laparoscopic hysterectomy

Conditions: Superior Hypogastric Plexus Block; Hysterectomy; Minimally Invasive Surgery; Laparoscopy; Pain, Postoperative; Gynecologic Disease

Summary: the primary indication for superior hypogastric plexus (shp) block is visceral pelvic pain, most commonly from malignancy of the ovary, uterus, cervix, bladder, rectum or prostate. per-cutaneous shp blocks should be done under guidance of ultrasonography, fluoroscopy, magnetic resonance or computed tomography. during minimally invasive laparoscopic surgery, percutaneous technique can be done under the guidance of cameras.

laparoscopic surgeries have many advantages over open surgeries. laparoscopic procedures are mostly preferred for surgical treatment of gynecologic diseases, because of best cosmetically results, less perioperative complications, early recovery, and less postoperative pain. there are many undesirable effects of systemic reactions to the pain. accordingly, multi-modal analgesic approach (including nerve blocks) for postoperative acute pain can decrease the side effects of the drugs (especially opioids) significantly. the primary indication for superior hypogastric plexus (shp) block is visceral pelvic pain, most commonly from malignancy of the ovary, uterus, cervix, bladder, rectum or prostate. per-cutaneous shp blocks should be done under guidance of ultrasonography, fluoroscopy, magnetic resonance or computed tomography. during minimally invasive laparoscopic surgery, per-cutaneous technique can be done under the guidance of cameras. shp block has been performed by anesthetists or surgeons in kocaeli derince training and research hospital regularly since they have discovered the advantages of this block technique. shp can be useful to decrease postoperative pain scores and opioid or nsaid consumption significantly.

Eligibility criteria:
inclusion criteria: * asa i - ii * elective laparoscopic hysterectomy exclusion criteria: * asa iii * different kind of surgery * known allergy to local anesthetic drugs * different analgesia protocol (ie: epidural, tap block,..) * refusal of the patient

Keywords: superior hypogastric plexus block hysterectomy minimally invasive surgery laparoscopy pain gynecologic disease