Kornimate/medical-research-clean huggingface dataset:
fibromyalgia treatment with enzyme dao

Conditions: Fibromyalgia

Summary: fibromyalgia is a complex and common chronic pain disorder that affects 12 million europeans. fibromyalgia causes persistent widespread pain in muscles, tendons, ligaments, and joints, as well as widespread tenderness to touch and the presence of extreme fatigue and weakness. histamine is a molecule derived from an essential amino acid, histidine. it is stored in mast cells and basophils and is excreted through the intestine, being degraded as it passes through the intestinal mucosa by the enzyme diamine oxidase (dao), which is found in this area. if there is any alteration in its metabolism and normal concentrations of histamine in the blood (50-70 mg/l) are not maintained, the free circulation of this amine in high concentrations triggers undesired effects, such as migraine, fibromyalgia, asthenia and atopy. dao deficiency is an alteration in the metabolism of dietary histamine that occurs when there is little activity of the dao enzyme. the low activity of the enzyme causes that a concentration considered normal of histamine from food cannot be metabolized and a transepithelial penetration of exogenous histamine occurs. in this way, histamine passes into the bloodstream, increasing its plasma concentration and once located freely in the blood, it is distributed throughout different parts of the body, producing adverse effects. one of the factors that causes dao deficiency is genetics. the genetic sequence of dao is found in a fragment located on chromosome 7 (7q34-q36) of the human genome. there are 85 single nucleotide variants (snps) located and identified in the human dao gene (aoc1). seven of these snps produce amino acid substitution, being candidates to cause alterations in the metabolic capacity of the enzyme. since histamine accumulation can trigger fibromyalgia, and the enzyme dao has been shown to degrade histamine, oral supplementation with dao food supplements, prepared from pig kidney, is suggested as a treatment for fibromyalgia. the objective of this study is to analyze whether dao enzyme supplementation reduces the characteristic symptoms of fibromyalgia. in addition, the prevalence of dao deficiency in women with fibromyalgia will be identified by genetic analysis of dao deficiency from a saliva sample. it will also be evaluated if patients require a lower intake of analgesics after supplementation with the enzyme dao.


Eligibility criteria:
inclusion criteria: * female * age between 30 and 59 years (included) * diagnosis of fibromyalgia * must sign an informed consent * able to follow-up at 2 and 6 months exclusion criteria: * pregnant or possibly pregnant * patients with change of pharmacological treatment in the last 3 months * patients with dao enzyme treatment * patients diagnosed with other severe diseases (i.e. cancer, cardiovascular disease, autoimmune disease or metabolic disease) * patients with multiple chemical sensitivity

Keywords: fibromyalgia diamine oxidase supplementation genetics treatment
abdominal compression administered early by the colonoscopist during water exchange colonoscopy

Conditions: Colonic Polyp; Colonic Adenoma

Summary: loop formation is the most frequent cause of cecal intubation failure during colonoscopy. to reduce the loop formation, external abdominal pressure is widely used and proved to be helpful. properly applied pressure can also decrease patients discomfort and shorten the cecal intubation time. the loop formation during water exchange is less severe as compared with during air insufflation and can be reduced quite readily. traditionally an assistant is not asked to administer abdominal compression until the endoscopist has struggled for some time and failed to reduce the loops by withdrawal. the colonoscopist can administer the abdominal compression whenever the scope is not advancing smoothly, probably in the early stage of loop formation. we test the hypothesis that colonoscopist administered abdominal compression to remove loops in their early stage of formation hastens cecal intubation. a total of 120patients will be randomized in a 1:1 ratio (n=60 per group). when the tip of the scope doesn't advance or paradoxical movements occur, loop reduction by withdrawal of the scope will be implemented. if looping persists, abdominal compression will be applied. in the endoscopist-administered abdominal compression (endoscopist) group, the colonoscopist will apply the compression with his right hand and counter the pressure by pushing the back of the patient with his left forearm with the colonoscope in his left hand. the compression will be administered at left lower quadrant when the scope is in the sigmoid colon and at left lower quadrant and upper abdomen, respectively, when the scope tip reaches the transverse or ascending colon. if the formation of loop cannot be overcome, an assistant will apply the abdominal compression instead. in the assistant-administered abdominal compression (assistant) group, an endoscopic assistant will apply abdominal compression when a loop is formed. the assistant will apply the compression at the left lower quadrant initially, but quickly shift to other parts as needed depending on the tip location of colonoscope. if manual compressions fail, then the patients' position will be changed.


Eligibility criteria:
inclusion criteria: * in the buddhist dalin tzu chi hospital, buddhist tzu chi medical foundation, chiayi, taiwan. * patients who undergo we colonoscopy performed by the two endoscopists (yhh and cwt) at the endoscopic suite will be included. exclusion criteria: * included patient declined to give consent, * age \<20 years old, * age \>80 years old, * previous partial colectomy, not completely consumed bowel prep regimen, massive ascites, or known colonic obstruction, morbid obesity (bmi ≥ 35).

Keywords: colonoscopy cecal intubation time
cohort study of adult patients with down syndrome at risk of developing alzheimer's disease (trial21)

Conditions: Down Syndrome; Alzheimer Disease

Summary: trial21 study is an interventional, open, one arm, prospective, national and single center study. a total of 200 patients with down syndrome, aged 35 years and over, without diagnosis of alzheimer's disease will be enrolled into the study. participating centre is institut jérôme lejeune; outpatient's clinic dedicated to treating patients with cognitive deficiencies of genetic origin including patients with down syndrome.

the aim of the study is to describe and follow a cohort of patients with down syndrome without diagnosis of alzheimer's disease at inclusion, in order to identify factors influencing the age of onset of the disease. the total study duration will be approximately 4 years. * inclusion period : 2 years * follow-up period per patient : 2 years patients will be then followed during 10 years for routine medical follow-up. in case of alzheimer's disease onset during this period, all data regarding diagnosis of ad will be collected for the study. data about dementia evolution and mortality in case of ad diagnosis during the study will also be collected during this follow-up period.

Eligibility criteria:
inclusion criteria: * male or female 35 years old and over ; * clinical diagnosis of down syndrome ; * patient attending the geriatric outpatient clinic * patient without diagnosis of alzheimer's disease; * patient covered by social welfare; * patient himself or legal guardian/representative willing and consenting to participate to the study by giving written informed consent; * patients must have a parent, or / and other reliable caregiver who agrees to accompany him/her to all visits, provide information about the patient as required by the protocol. the parent or caregiver must be a constant and reliable informant with sufficient contact with the patient to have detailed knowledge of the patient's adaptive functioning in order to be able to complete the assessments accurately. exclusion criteria: * patient presenting a contraindication to mri in particular carrier of metal implants such as pacemakers; * patient presenting a serious, severe or unstable pathology (left to the investigator's discretion) whose nature may interfere with the evaluation parameters; * patient without alzheimer's disease diagnosis but with severe dementia; * participation in other clinical trials in the last 3 months prior to the study; * pregnant woman.

Keywords: down syndrome alzheimer disease marker neuropsychological prodromal risk factors
performance diagnosis of a patent foramen ovale during lung transplantation using transesophageal echocardiography

Conditions: Lung Transplant; Complications

Summary: the investigators hypothesis is that an injection into the inferior vena cava associated with a provocation maneuver should allow to increase the incidence of fop found by transesophageal echocardiography in a population of patients undergoing lung transplantation.


Eligibility criteria:
inclusion criteria: * aged 18 years old minimum * benefiting from a lung transplant * having an upper vena cava catheter and a lower vena cava catheter set up as part of the usual care * having signed a consent form * affiliated to a insurance scheme or beneficiary (excluding ame) exclusion criteria: * pregnant or lactating women * having a contraindication to the insertion of the esophageal ultrasound probe * deprived of liberty or under guardianship
quantification of dilutional anemia in the initial phase of sepsis management: preliminary retrospective study

Conditions: Sepsis

Summary: this is a single-center retrospective study conducted at mercy hospital, aiming to investigate the correlation between changes in hemoglobin (hb) levels and the volume of vascular refill administered during the first 48 hours.

vascular refill is central to the initial management of hypotension in sepsis, and is often started even before the patient is admitted to intensive care. over the past 20 years, we have moved from ultraliberal fluid resuscitation to restrictive resuscitation. indeed, in the early 2000s, the implementation of an early and aggressive hemodynamic optimization strategy, including liberal vascular filling, improved the survival of critically ill patients, and ushered in the era of the surviving sepsis campaign. however, studies have shown increased morbidity and mortality associated with a positive fluid balance. restrictive approaches to fluid resuscitation and/or deressuscitation were then tested. while these approaches failed to demonstrate any benefit in terms of mortality, they did have the merit of demonstrating their feasibility and good tolerability, albeit with a little-explored pathophysiology. little is known about the problem of dilutional anemia in the acute phase of septic shock.

Eligibility criteria:
inclusion criteria: * patients with septic shock, admitted to mercy hospital between november 1, 2022 and july 31, 2023, with noradrenaline administration for at least 6 hours and at least 2 hemoglobin measurements during the first 48 hours of resuscitation. exclusion criteria: * patients with acute bleeding or blood transfusion before or during the first 48 hours of resuscitation.

Keywords: hemoglobin levels
trial comparing laparoscopic sacropexy and vaginal mesh surgery for women cystocele repair.

Conditions: Cystocele

Summary: the primary objective of this study is to compare with pfdi-20 questionnaire the functional outcome of laparoscopic sacrocolpopexy and vaginal mesh surgery in the treatment of symptomatic exteriorised cystocele up to 4 years after surgery. the secondary objectives of this study are the following: 1. to compare the two techniques for anatomical results based on the clinical evaluation of patients with pop-q. 2. to overall quality of life assessment and expectations of patients. 3. to compare the two techniques for the long-term safety. the evaluation will focus on the adverse effects of long-term sexual and genital symptoms, urinary and digestive functional symptoms, and chronic pelvic pain. 4. to compare the improvement of the functional outcome assessed by pfdi-20 questionnaire (matched-analysis before versus after).


Eligibility criteria:
inclusion criteria: * all the patients included in the prospere study will be included in the prospere-4 study. the inclusion criterias for the prospere study are: * written informed consent * insured under the french social security system exclusion criteria: * unwillingness or inability to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the study protocol * participation in another trial
critical analysis of the results in the management of penetrating abdominal trauma in the past fifteen years.

Conditions: Penetrating Abdominal Trauma

Summary: penetrating abdominal trauma (pat) incidence varies between 3,1-12,8% and it comprises a wide range of injuries with varying patterns on diagnostic imaging. last guidelines published in 2014 recommend the use of fast and cxr as the gold standard method for evaluating. computed tomography (ct) is widely used in stable patients with pat and it requires intravenous contrast and patient irradiation, leading to additional costs to healthcare services. this study aims to assess the management of pat in our institution and with its results review the actual protocol.

penetrating abdominal trauma (pat) incidence varies between 3,1-12,8% and it comprises a wide range of injuries with varying patterns on diagnostic imaging. last guidelines published in 2014 recommend the use of fast and cxr as the gold standard method for evaluating. computed tomography (ct) is widely used in stable patients with pat and it requires intravenous contrast and patient irradiation, leading to additional costs to healthcare services. this study aims to assess the management of pat in our institution and with its results review the actual protocol. a retrospective unicentric study will be conducted on a prospective database of stab wounds at the department of general surgery of hospital del mar over a 15-year period. the normality of the distribution of quantitative variables will be assessed using the kolmogorov-smirnov test. comparison between qualitative variable groups will be performed using the chi-square test or fisher's exact test when appropriate, and non-parametric tests like the mann-whitney u test will be used to evaluate the significance of differences in means of quantitative variables. the odds ratios (or) of predictor variables with outcome variables will be determined.

Eligibility criteria:
inclusion criteria: * all penetrating trauma patients admitted in the emergency department. exclusion criteria: * all patients with any other diagnostic different from penetrating trauma * blunt trauma patients admitted in the emergency department

Keywords: penetrating trauma trauma surgery explorative laparoscopy trauma laparotomy efast
spark-all: calaspargase pegol in adults with all

Conditions: Acute Lymphoblastic Leukemia

Summary: the purpose of this phase 2/3 study is to confirm the recommended doses and to evaluate the safety and pharmacodynamics of calaspargase pegol for the treatment of adult patients with philadelphia-negative acute lymphoblastic leukemia.

the study will be conducted in 2 parts. part 1 is a dose confirmation run-in period. part 2 will enroll the remaining participants at the dose as confirmed or recommended in part 1.

Eligibility criteria:
inclusion criteria: * aged ≥22 and \<55 years with newly-diagnosed and cytologically confirmed and documented philadelphia-negative b-cell or t-cell all by world health organization (who) classification (2016). * eastern cooperative oncology group performance status (ecog ps) 0 to 2. * no prior therapy for all such as chemotherapy and radiation therapy before signing the informed consent except for limited treatment (≤7 days) with corticosteroids or hydroxyurea and a single dose of intrathecal cytarabine. exclusion criteria: * patients with philadelphia chromosome positive all, burkitt's leukemia, mixed lineage/mixed phenotype acute leukemia, and acute undifferentiated leukemia per who classification (2016). * patients with down syndrome. * patients with hepatitis b (positive for hbs antigen), and hepatitis c (hcv antibody) at inclusion * participants known to be hiv-positive. * known history of non-gallstone-related pancreatitis. * known severe hepatic impairment (bilirubin \>3 x upper limit of normal \[uln\]; transaminases \>10 times uln. * pre-existing history of hepatic veno-occlusive disease (vod). * age ≥ 55 years. * bmi \> 35 kg/m2.

Keywords: acute lymphoblastic leukemia all ph-negative b-cell and t cell all philadelphia-negative all calaspargase pegol asparlas adult acute lymphocytic leukemia newly diagnosed all untreated all
screening for studies on nystagmus and strabismus

Conditions: Nystagmus; Strabismus

Summary: this screening protocol is designed to help recruitment patients for national eye institute (nei) studies on nystagmus and strabismus. patients must meet specific requirements of a research study, and this protocol serves as a first step for admitting patients to an appropriate program. candidates will undergo a medical history, physical examination, eye examination and blood test. the eye examination includes measurement of eye pressure and dilation of the pupils to fully examine the lens, vitreous and retina. specialized tests will be done only if needed to determine eligibility for a nystagmus or strabismus study. these include routine laboratory tests, non-invasive imaging, questionnaires, and other standard tests. if needed, a test called oculography may be done to record eye movements. there are two procedures for recording and documenting these movements. in the infrared system, the patient wears a pair of glasses or goggles and looks at a red light while the head is kept steady. in the search coil system, the eye is numbed with anesthetic eye drops and a soft contact lens is placed on the eye. then the patient looks at a red light while the head is held still. each oculography session lasts 20 to 30 minutes. photographs of the eye may be taken. when the screening is completed, patients will be informed of their options to participate in a study. patients who are ineligible for a current study will be informed of alternative treatments or options. no treatment is offered under this protocol.

this protocol is designed for the screening of patients with either diagnosed or undiagnosed conditions, and serves as a first step for individuals who may be eligible and wish to participate in national eye institute (nei) clinical research studies. each individual will be thoroughly evaluated during the screening process to determine if they are suitable candidates for inclusion in any of the nei ongoing studies. the screening evaluation will include past and current medical histories, and an appropriate physical examination. other routine diagnostic procedures and tests may also be completed in order to help determine a subject's eligibility. these tests and procedures are of minimal risk. once the screening process is completed and their eligibility assessed, the subjects will be informed of their options to participate in one or more of the current clinical research studies. if no appropriate protocol is identified, recommendations for other treatment options may be given to the individual, their primary doctor or referring physician.

Eligibility criteria:
* inclusion criteria inclusion and exclusion criteria vary with the particular protocol for which a patient is being screened. in addition to those diagnoses currently under study, subjects with unusual, interesting, or unknown conditions that require the establishment of a diagnosis may be eligible for inclusion in this study.

Keywords: eye movements amblyopia orthoptics lazy eye eye development nystagmus strabismus screening protocol eye movement disorders
influence of myocardial shortening on coronary tortuosity

Conditions: Coronary Artery Vessels; Coronary Artery Disease

Summary: this study is a retrospective analysis where coronary arteriograms are being analyzed to determine whether the presence of tortuous coronary arteries correlate with any specific measures of left ventricular mass or left ventricular function on echocardiography.


Eligibility criteria:
inclusion criteria: * subjects referred for angiography * echocardiography performed within 3 months. exclusion criteria: * connective tissue disease * severe lv dysfunction * prior coronary artery bypass surgery * major adverse coronary event between angiogram and echo procedures * moderate or greater valve disease * acute coronary syndrome
a study of rbt-9 in healthy volunteers and volunteers with stage 3/4 chronic kidney disease

Conditions: Healthy Volunteers; Chronic Kidney Disease

Summary: this is a phase 1b, single-center, dose-escalating study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic effect of rbt-9 in healthy volunteers and in subjects with stage 3/4 ckd.


Eligibility criteria:
inclusion criteria: 1. male and female subjects age 18 to 80 years (inclusive, at time of icf). 2. body weight \<125 kg. 3. able and willing to comply with all study procedures. 4. female subjects must be either post-menopausal for at least 1 year or surgically sterile (tubal ligation, hysterectomy or bilateral oophorectomy) for at least 3 months, or if of childbearing potential, have a negative pregnancy test and agree to use dual methods of contraception, or abstain from sexual activity from screening until 28 days after study drug administration. male subjects with female partners of childbearing potential must agree to use a highly effective method of contraception from screening until 28 days after study drug administration. all fertile men with female partners of childbearing potential should be instructed to contact the investigator immediately if they suspect their partner might be pregnant (e.g., missed or late menstrual period) at any time during study participation. 5. ckd stage 3 as determined by a gfr between 30-59 ml/min as estimated using the ckd-epi equation. 6. ckd stage 4 as determined by a gfr between 15-29 ml/min as estimated using the ckd-epi equation. exclusion criteria: 1. history of malignancy, except carcinoma in situ in the cervix, early stage prostate cancer or non-melanoma skin cancers. cancer free for less than 5 years. 2. use of investigational drugs or participation in another clinical trial within 30 days or 5 half-lives prior to screening, whichever was longer. 3. serum ferritin \>500 ng/ml or received iv iron within 28 days of screening. 4. women who are pregnant, breastfeeding, or planning to become pregnant while participating in the study. 5. any significant acute or chronic diseases, excluding ckd (≥ 15 ml/min); if ckd is present, those not at their baseline of renal function. 6. abnormal baseline liver tests or hepatitis serologies that suggest active infection. 7. regular use of drugs of abuse and/or positive findings on urinary drug screening. 8. current tobacco use and/or positive findings on urinary cotinine screening. 9. severely physically or mentally incapacitated and who, in the opinion of investigator, are unable to perform the subjects' tasks associated with the protocol. 10. presence of any condition which, in the opinion of the investigator, places the subject at undue risk or potentially jeopardizes the quality of the data to be generated. 11. history of photosensitivity or active skin disease which, in the opinion of the investigator, could increase the risk of photosensitivity. 12. known hypersensitivity or previous anaphylaxis to rbt-9 or tin-based product.