Kornimate/medical-research-clean huggingface dataset:
medical device for drug allergy diagnosis

Conditions: Drug Hypersensitivity

Summary: the cobiophad project targets the development of a highly sensitive, selective, and multiplexed diagnostic device to provide a quick and inexpensive in vitro test to address the most prevalent drug hypersensitivity to betalactams antibiotics, (blcs). during a retrospective study, blc structures involved in drug hypersensitivity will be identified from sera of allergic patients (versus controls) and coupled on the device. a prospective study will be performed for the recruitment of samples corresponding to patients with known ige hypersensitivity to blcs based on results from allergy tests and clinical history. controls will include: non-allergic individuals with known tolerance to betalactams. the samples will be used for the validation of the cobiophad device in real settings.


Eligibility criteria:
inclusion criteria: - patients with known hypersensitivity to blc (proven by means of in vivo tests) (cases) exclusion criteria: * patients with contraindications to blc allergy work-up * patient refusal to enter the study * vulnerable patients according to french regulation

Keywords: betalactams in vitro diagnosis
quetiapine fumarate (seroquel) compared to placebo in the treatment of children & adolescents with bipolar i mania

Conditions: Bipolar Disorder

Summary: the purpose of this study is to demonstrate efficacy and safety of quetiapine fumarate (seroquel) compared with placebo in the treatment of children and adolescent patients with bipolar i mania.


Eligibility criteria:
inclusion criteria: * patient is able to provide written assent and the parents or legal guardian of the patient is able to provide written informed consent before beginning and study related procedures * patient has a documented clinical diagnosis of bipolar i mania * patient's parent or legal guardian will be able to accompany the patient at each scheduled study visit exclusion criteria: * patients (female) must not be pregnant or lactating * patients with a known intolerance or lack of response to previous treatment with quetiapine * patients who have previously participated in this study

Keywords: bipolar i mania
effectiveness of rifaximin combined with thiopurine on preventing postoperative recurrence in crohn's disease

Conditions: Crohn Disease

Summary: some studies have shown that rifaximin is effective in the management of crohn's disease. meanwhile, its adverse effect is tolerable. but no study has been conducted to assess its effect on preventing postoperative recurrence. thus, we conduct a randomised controlled study to assess the effect of rifaximin combined with thiopurine on preventing postoperative endoscopic recurrence in crohn's disease, compared with thiopurine. the primary endpoint is the rate of endoscopic recurrence at 6 months.


Eligibility criteria:
inclusion criteria: 1. consecutive patients with crohn's disease undergoing intestinal resection of all macroscopic diseased bowel, with an endoscopically accessible ileocolic anastomosis; 2. enrolled patients must have one or more risk factor for the development of postoperative recurrence including penetrating disease behaviour, prior bowel resection, and active smoking. exclusion criteria: 1. severe comorbidities; 2. with a stoma; 3. with malignancy; 4. pregnancy; 5. intolerant of thiopurine drugs; 6. with contraindication of using rifaximin or thiopurine drugs.
nt-i7 in combination with atezolizumab in previously untreated, pd-l1-expressing, locally advanced or metastatic nsclc

Conditions: Carcinoma, Non-Small-Cell Lung; Non-Small Cell Lung Cancer; Non-Small Cell Lung Carcinoma; Nonsmall Cell Lung Cancer; Non Small Cell Lung Cancer

Summary: this is a multicenter, open-label, single-arm phase ii study to evaluate anti-tumor efficacy and safety of nt-i7 in combination with atezolizumab in subjects with pd-l1-expressing (tps ≥ 1%), metastatic (stage iv) or locally advanced squamous or non-squamous nsclc who have not received prior systemic therapy in the metastatic or locally advanced setting. eligible subjects must have measurable disease according to recist 1.1. this phase ii study will enroll up to 83 subjects.


Eligibility criteria:
inclusion criteria: * have histologically or cytologically confirmed metastatic or locally advanced nsclc, and have not received prior systemic therapy. subjects with locally advanced disease must have stage iii nsclc and are not candidates for surgical resection or definitive chemoradiation * tumor pd-l1 expression (tps≥1%) as determined by pd-l1 22c3 immunohistochemistry local or central assay. * have measurable disease * agree to provide screening biopsy (or archival tissue) at screening to assess pd-l1 * ecog 0-1 * adequate hematologic and end organ function exclusion criteria: * prior systemic anti-cancer therapy * nsclc with egfr, or alk, or braf or ros or red or other genomic tumor aberrations which have available therapy * prior radiotherapy within 2 weeks of start of study treatment * known active cns metastasis or carcinomatous meningitis * severe reactions to mabs or iv immunoglobulin preparations * autoimmune disease history in past two years

Keywords: advanced metastatic nsclc pd-l1 atezolizumab nt-i7 non small cell lung cancer non-small cell lung cancer non-small cell lung carcinoma nonsmall cell lung cancer efineptakin alfa efineptakin
clinical study of escitalopram oxalate combined with tavns in depression and concomitant inflammatory symptoms

Conditions: Major Depressive Disorder; Rheumatoid Arthritis

Summary: this study is expected to include 90 patients with major depressive disorder and rheumatoid arthritis as study subjects.randomly divided into 3 groups: drug + vns stimulation group, drug + sham stimulation group and drug group, each group had 30 patients.the treatment period of each group was 8 weeks.age and sex were matched in all three groups.scale evaluation and inflammatory factor test were performed before treatment (baseline), at week 4 and week 8 after treatment.head mri, evoked potential, and electrocardiogram were performed at baseline and at the end of week 8.

1. drug +vns stimulation group: both vns and escitalopram oxalate tablets were treated for 2 months. vns stimulation was treated once a day for 30 minutes at the intensity of 1-2ma. drug treatment: the dose of escitalopram oxalate tablets was maintained at 10-20 mg/ day 2. drug + sham stimulation group: the patients were treated with escitalopram oxalate tablets and sham vns for 2 months. sham vns stimulation: the sham stimulation device automatically stops after 30 seconds of stimulation. drug treatment was the same as the above group. 3. drug group: the dose of escitalopram oxalate tablets was maintained at 10-20 mg/ day without vns stimulation

Eligibility criteria:
inclusion criteria: * age 18-65 years old, in accordance with dsm-5 diagnostic criteria for major depressive disorder, or meet the diagnostic criteria for rheumatoid arthritis. the major depressive disorder is first or at least not used in the 5 half-life of the drug. antidepressants, antipsychotics or anticonvulsants. * hamilton depression rating scale (hamd) 17 scores over 17 points. exclusion criteria: * brain organic lesions (such as cerebral hemorrhage, large area cerebral infarction, encephalitis, epilepsy); cardiac qtc interval \> 450ms; * currently or have been diagnosed with other major diseases (such as coronary heart disease, pulmonary heart disease, etc.) * those who are currently or have been diagnosed with other mental disorders other than major depressive disorder (except for anxiety disorder); * patients who have a serious risk of suicide or who have had suicide attempts; * those who are using or have been treated with escitalopram oxalate are not effective; * those who are participating in or have participated in vagus nerve or transcranial electrical stimulation for less than 3 months; * mri scan taboos and high-risk groups; * pregnancy, breastfeeding or planning for pregnancy during the trial; * refusal to sign informed consent.
study of aldurazyme® replacement therapy in patients with mucopolysaccharidosis i (mps i) disease

Conditions: Mucopolysaccharidosis I; Hurler Syndrome; Hurler-Scheie Syndrome; Scheie Syndrome

Summary: this is a multi-center, open label, study conducted to evaluate the safety of laronidase administered by intravenous drip infusion in japanese patients with mps i disease. following baseline evaluation, patients will receive weekly infusions of jc0498 at an intravenous dose of 100 units/kg. patient safety will be monitored continuously throughout the trial. in addition, the effects of jc0498 treatment in this patient population will be assessed by periodically evaluating aspects of mps i disease in patients at scheduled intervals over the duration of the trial. since patients may be eligible for the trial if they have received jc0498, a portion of the data may be captured retrospectively and recorded onto the case report forms (crfs). this study represents the first good clinical practice (gcp) effort to characterize mps i in the japanese population and evaluate the effects of jc0498 on disease manifestations.


Eligibility criteria:
inclusion criteria: * written informed consent/assent of the patient or written informed consent of the parent(s) or the legal guardian(s), depending on the age of the patient, is required prior to any protocol-related procedures being performed; this includes information regarding hematopoietic stem cell transplantation (hsct) in order to assure that the guardian(s) is fully informed regarding the risks and benefits of this alternative treatment for patients eligible for the trial and who have severe manifestations of mps i with neurodegeneration. * have a clinical diagnosis of mps, confirmed by measurable clinical signs and symptoms of mps i. * have confirmed iduronidase deficiency with a leukocyte alpha-l-iduronidase enzyme activity level of less than 10.0% of the lower limit of the normal range of the measuring laboratory (srl) exclusion criteria: * the patient is under consideration for or has previously undergone hematopoietic stem cell transplantation. * the patient has acute hydrocephalus at the time of enrollment. * the patient has a clinically significant organic disease (with the exception of symptoms relating to mps i) including: cardiovascular, hepatic, pulmonary, neurologic, or renal disease, other serious intercurrent illness, or extenuating circumstances that, in the opinion of the investigator, would preclude participation in the trial or potentially decrease survival. * the patient has received any investigational product within 30 days prior to trial enrollment (exception: jc0498). * the patient has known severe hypersensitivity to jc0498 or components of the delivery solution.

Keywords: mps i disease
short term response of breast milk micronutrient concentrations to a lipid based nutrient supplement in guatemalan women

Conditions: Malnutrition

Summary: research goals include evaluating the relative impact of maternal nutritional status versus recent dietary intake on breast milk micronutrient composition, and evaluating the impact of a maternal lipid based nutrient supplement (lns) on breast milk micronutrient composition.

the study includes a cross sectional and an interventional component. maternal dietary intake and nutritional status will be compared to breast milk micronutrient composition in a cross sectional manner. the short term effect of maternal dietary intake on breast milk micronutrient composition will be examined using an intervention with a controlled diet and lns. infants will be test-weighed during the lns intervention in order to calculate the infant micronutrient intake from the control and lns intervention days. mother-infant dyads will be recruited into the study and the order in which they will receive the 3 treatments will be randomized. all mothers will receive all treatments. the mothers will be invited to the clinic on 4 separate occasions. during the first study visit, maternal blood will be collected, anthropometric indices will be assessed, and food frequency and demographic characteristic surveys will be administered. during the 2-4 visits, the lns intervention will take place. mothers will arrive at the clinic fasted, and a fasted milk collection will occur. subsequently, mothers will be provided 3 meals based on local foods with low-nutrient density. milk will be collected for 8 hours at each infant feed (ad libitum). a 24 hour dietary recall will be conducted. mothers will receive 1) no lns, 2) a single dose of lns with breakfast, or 3) a single dose of lns split into 3 parts with their meals throughout the day. infants will be test weighed before and after each feed to calculate their nutrient intake from breast milk and the impact of the different supplementation schemes on their nutrient intake.

Eligibility criteria:
inclusion criteria: * mother 18-40 years of age * apparently healthy, with no acute illness * willing to stay in clinic for breast milk sampling, and adhere to all study procedures * 4-6 months of lactation and ≥ 8 breast feeding episodes per day (usual frequency is \>20 times/day) * last birth was a singleton birth * only breastfeeding one child * child is 4-6 months of age exclusion criteria: * current supplement use (iron + folic acid excepted) * self reported mastitis or other breast infections * reported problems with breastfeeding which might affect study procedures * last birth was premature (\>4 weeks pre-term by maternal report) * measured body mass index (bmi) of less than 18.5 or a measured mid upper arm circumference (muac) of less than 12.5 cm * temporary- if the mother or her infant present with an acute illness, (for example flu or diarrhea,) they will be rescheduled to return on a later date when both are apparently healthy. * allergy to milk, milk products, or peanuts.
characterization of immune-response in autoimmune encephalitis and paraneoplastic neurological syndromes

Conditions: Autoimmune Encephalitis; Paraneoplastic Neurological Syndrome

Summary: autoimmune encephalitis (ae) and paraneoplastic neurological syndromes (pns) are rare neuroimmune syndromes with a wide range of clinical presentation but without pathognomonic clinical sign facilitating the diagnosis. a lot of differential diagnoses are possible such as neurodegenerative diseases or viral infections. although rare the diagnosis of ae or pns is essential because despite severe neurological symptoms, patients can be cured by appropriate immunotherapy. autoantibodies highly specific of ae and pns has been described in the serum and cerebrospinal fluid of the patients and can be used as biomarkers of the disease. their presence can predict an autoimmune origin and in many cases a good prognosis after immunotherapy. however, if some autoantibodies are now well-characterized and industrial kits have been developed to detect them, in numerous cases of highly suspect ae or pns no specific autoantibodies are identified leading frequently to an inappropriate treatment. furthermore, as the mechanisms of ae and pns is still unknown, treatments are not optimal and in some cases inefficient. there is no prognosis biomarker able to predict the patient's sensitivity to immunotherapy and there are only few clues to know how the immune system can provoke the neuropsychiatric symptoms observed in the patients.


Eligibility criteria:
inclusion criteria: * patient with neurological disorder * patient with antibodies or not in sera or csf exclusion criteria: - no available clinical data

Keywords: autoimmune encephalitis paraneoplastic neurological syndromes genetic
family dietary coaching to improve nutritional intakes and body weight control

Conditions: Primary Prevention; Obesity Prevention; Body Weight Control

Summary: we hypothesize that family dietary coaching for one school year will allow a nutritional shift towards following recommendations and improve health indicators in free-living children and adults.

insufficient evidence supports the feasibility and the efficacy of current nutritional recommendations to prevent obesity. the purpose of this study is to test the hypothesis that family dietary coaching would improve nutritional intakes and health indicators in free-living children and adults. intervention: the 1013 participating families (1013 children and 1013 parents) are randomly assigned to group a (advice to reduce fat and to increase complex carbohydrates), group b (advice to reduce both fat and sugars and to increase complex carbohydrates) or a control group (no advice). ga and gb receive monthly phone counseling and internet-based monitoring. main outcome measures are changes in nutritional intakes and body mass index throughout the intervention in both children and adults. secondary outcomes included changes in fat mass, physical activity, fasting blood indicators and food-related quality of life.

Eligibility criteria:
inclusion criteria: * second- or third-grade pupils * affiliation with the french health care system * written informed consent exclusion criteria: no inclusion criteria were based on pathological, ethnical or socio-educative indicators

Keywords: obesity prevention children adults family dietary coaching body mass index fat mass
infectious outcomes following pancreas transplantation

Conditions: Pancreatic Transplantation

Summary: the proposed protocol aims to characterize the infectious episodes in pancreas transplant recipients under the current medical care. knowing these patients infectious risks, the types of infections that commonly affect them and the morbidity and mortality associated with it will provide valuable information in the evaluation of the safety and efficacy of the current practices. the information generated by this study will also serve as the basis for development of strategies targeting prophylaxis of infectious episodes.

the objectives of the study are: 1. to determine what is the frequency of infectious complications following pancreas transplantation 2. characterize the clinical and microbiological aspects of the infectious complications following pancreas transplantation 3. identify predictors for infection following pancreas transplantation 4. determine the frequency of graft loss and associated mortality of infectious complications following pancreas transplantation

Eligibility criteria:
inclusion criteria: * patients who underwent pancreas with or without kidney transplantation at the university of pittsburgh medical center from january 1st 2002 to december 31st 2005 * patients must be above 18 years of age * patients undergoing retransplantation may be included. exclusion criteria: * history of pancreas transplantation at another institution

Keywords: transplant pancreas
size up bicuspid with the lira method: the sublime study

Conditions: Bicuspid Aortic Valve (BAV)

Summary: transcatheter aortic valve replacement (tavr) outcomes in patients with raphe-type bicuspid aortic valve (bav) are still suboptimal for the non negligible rate of stroke and permanent pacemaker implantation. there is still lack of consensus on the optimal sizing method for prosthesis selection in bav patients. the objective of the present study is to evaluate the efficacy and safety of the lira sizing method in raphe-type bav patients undergoing tavr.

bicuspid aortic valve (bav) still represents a challenge for percutaneous treatment due to the peculiar anatomy. bav patients have been historically excluded from major randomized controlled trials. observational data have showed a high rate of paravalvular leak (pvl) with the use of self-expanding prostheses and a non-negligible rate of annular rupture with the use of balloon expandable valves. more recent data have shown better outcomes with current generation prostheses although the rate of stroke and permanent pacemaker implantation remains high. these suboptimal results, possibly related to bav different anatomy, have advocated the use of different sizing method for prosthesis selection in this setting. recent evidence has shown that transcatheter heart valve (thv) anchoring in bav patients might occur at the raphe-level, defined as the lira (level of implantation at the raphe) plane. thus, a novel supra-annular sizing method based on the measurement of the perimeter at the raphe-level, the lira-method, has been developed in our center and validated in small cohorts of patients. the aim of our study is to evaluate the efficacy and safety of the lira method in raphe-type bicuspid patients undergoing tavr.

Eligibility criteria:
inclusion criteria: * all patients over 18 years old with severe aortic stenosis and type 1 or 2 bav according to sievers classification) undergone tavr with self-expanding supra-annular prostheses sized according to the lira method between september 2018 and june 2024 exclusion criteria: * redo-tavr * tavr performed in emergency setting * tavr performed for severe aortic regurgitation

Keywords: lira method bicuspid aortic valve tavr
risk factors for post-eswl and post-ercp pancreatitis

Conditions: Chronic Pancreatitis; Risk Factors; ERCP; ESWL

Summary: the study aimed to identify risk factors for post-ercp pancreatitis(pep) after eswl, and the relationship between the occurrence of post-eswl pancreatitis and pep.


Eligibility criteria:
inclusion criteria: * patients diagnosed with chronic pancreatitis and treated with both eswl and subsequent ercp exclusion criteria: * patients with isolated pancreatic tail stone * patients with suspected or established malignancy * patients with pancreatic ascites * patients attending other interventional clinical trials * patients with non-correctable coagulation disorder * patients with pregnancy