Kornimate/medical-research-clean huggingface dataset:
a phase ii, randomized, double-blind, placebo-controlled, in parallel groups clinical trial to assess the safety and efficacy of dietary supplementation with tryptophan to achieve weight loss, and its neuropsychological effects in adolescents with obesity

Conditions: Obesity

Summary: a phase ii, randomized, double-blind, placebo-controlled, in parallel groups clinical trial to assess the safety and efficacy of dietary supplementation with tryptophan to achieve weight loss, and its neuropsychological effects in adolescents with obesity.


Eligibility criteria:
inclusion criteria: 1. both male and female patients, attending the pediatric endocrinology service on an out-patient basis. 2. age from 12 to 17 years, inclusively. 3. presence of a bmi \> or = to 2sd and \< or = to 4sd (standard deviations) for their age and sex (spanish cross-sectional growth reference tables of 2008) 4. patients must have an educational level that permits adequate communication and must agree to cooperate in all the tests and examinations included in the protocol. 5. subjects of reproductive potential must use an effective birth control method during the study. women of reproductive age will be recruited after a negative pregnancy test. 6. the informed consent of the parents or legal representative and of the young adults is required. exclusion criteria: 1. obesity secondary to an endocrine disease (hypothyroidism, cushing?s syndrome, polycystic ovary, hypothalamic syndromes, hypogonadism) or the use of medications such as cortisol. 2. concomitant administration of other psychotrophic medication such as antidepressants or anxiolytics. 3. patients included in the study must not be taking any vitamins or nutritional supplements or any anti-obesity preparations, including herbal remedies, pharmacy products or homeopathic products. 4. patients with a known psychiatric disorder. 5. patients treated with any kind of structured psychotherapy regime. 6. patients with type 2 dm, arterial hypertension (blood pressure above the 95 percentile for gender and height) or steatotic liver (hypertransaminasemia with echographic image of fatty liver). 7. patients with any severe food intolerance, or with a known allergy to any of the substances used in the study. 8. patients in treatment with oral hypoglycemiants. 9. pregnant or breast-feeding.
uz brussel hrmc registry of brugada syndrome

Conditions: Brugada Syndrome

Summary: the monocentric uzb registry for brugada registry is intended to collect all data on patients affected by brugada syndrome at uz brussel hospital (uzb).

the monocentric uzb registry for brugada registry is intended to collect all data on patients affected by brugada syndrome. these includes: 1. demographical data: age, sex 2. antropometric data: height, weight, bmi 3. clinical data: comorbidities, arrhythmias, pm or icd implantation, therapy 3) data on the families: number of family members, sudden death history. 4) data on the genetics 5) data on: ecg, echocardiography, ct scan, mri of heart, mri of brain, ecg imaging, 3d electroanatomical mapping and ablation

Eligibility criteria:
inclusion criteria: * brugada syndrome diagnosis exclusion criteria: * other diagnosis different from brugada syndrome
measurement of angiogenic related growth factors in urine and blood from patients with pulmonary vein stenosis

Conditions: Multivessel Pulmonary Vein Stenosis

Summary: prospective, single center, descriptive study in 14 infants/children with multivessel pulmonary vein stenosis stratified for patients with or without underlying cardiac disease. group 1: patients without additional structural heart disease and multivessel pulmonary vein stenosis. group 2: patients with additional structural heart disease and multivessel pulmonary vein stenosis.

patients identified at the time of presentation to their cardiologist will be asked to provide a urine sample for analysis. if blood is being drawn for other clinical tests, an extra vial of blood will be collected for measurement of bfgf, vegf, angiopoietin 1\&2 and ephrin. at the time of blood draws, approximately 4 cc's of heparin blood will be obtained and processed as detailed below. blood and/or urine samples will be coordinated through the data manager and will be performed only when blood is being obtained for other reasons. initially, blood samples will be sent to lab control, spun down, and the plasma isolated. plasma will be coded, then frozen at -200c in the research lab. urine samples will be aliquoted into vials and stored at -20 until further analysis. all patient information will be kept confidential. individual results will not be provided to patients. identifiers to patient information will be maintained. no identifying patient information will be used in publications that might result from these studies. information to be collected by the data manager will include age, sex, date of diagnosis and interventions. the specific aim is to assess angiogenic growth factor concentrations in urine and blood from patients with both congenital and acquired multivessel pulmonary vein stenosis.

Eligibility criteria:
inclusion criteria: * diagnosis can be based on clinical and radiographic grounds or at the time of biopsy or prior surgical procedures. the diagnosis must be consistent with multivessel pulmonary stenosis. * there must be evidence of severe pulmonary vein stenosis in at least two pulmonary veins. * must give written informed consent according to institutional guidelines exclusion criteria: * mechanism of pulmonary venous obstruction due to obvious anatomic cause, such as extrinsic compression

Keywords: angiogenic related growth factor
gadd34 and type i ifn response genes in sle

Conditions: Systemic Lupus Erythematosus

Summary: gadd34 (growth arrest and dna damage inducible-protein) is a regulatory subunit of pp1 (phosphatase 1) phosphatase which dephosphorylates eif2alpha (eucaryotic initiation factor 2 alpha subunit), representing a negative feedback loop of the unfolded protein response (upr). moreover, gadd34 is necessary for type i interferon (ifn) production in response to viral infection in murine models. we investigate here the expression of gadd34 in systemic lupus erythematosus (sle), in which type i ifn has an important pathogenic role. we report a case-control study on gadd34 gene expression in pbmc (peripheral blood mononuclear cells) of sle patients (n=60) and age- and sex-matched healthy controls (n=30). the level of gadd34 gene expression, as well as of type-i ifn response genes in pbmc is measured by quantitative pcr.


Eligibility criteria:
inclusion criteria: * man and woman over 18 years old. * patients suffering from sle (slicc criteria) * patients having given their "non-opposition" * patients with social security affiliation (required in france) exclusion criteria: * patients suffering from other auto-immune disease (except sapl, thyroiditis, and gougerot sjogren syndrome) * patients with viral infection within 15 days * people with special protection (defined in articles l1121-§5-8 and articles l3212-§1-3 of french health care law)

Keywords: unfolded protein response gadd34 type i ifn ifn response genes type ii ifn anti-dna autoantibodies
the effect of high-calorie formula on nutritional and clinical outcomes among infants after congenital heart surgery

Conditions: Congenital Heart Disease in Children; Malnutrition, Child

Summary: the goal of this clinical trial is to compare the effect of high-calorie density formula (hdf) and standard formula (sf) in infants with congenital heart surgery. the main questions it aims to answer are: 1. is there any difference in nutritional status between both groups after 3 months? 2. is there any difference in calorie intake per day between both groups during hospitalization? 3. is there any difference in clinical outcomes (mortality, duration of using mechanical ventilation, length of stay, and events of side effects) between both groups? a group of participants will be given hdf (1 kcal/ml) from enrollment until three months. researchers will compare them to the group of participants who are given sf (0.67 kcal/ml) to see if there is any difference in nutritional status, calorie intake, and other clinical outcomes between the two groups.

the study is a randomized, double-blind controlled trial to compare the efficacy of hdf formula compared to sf in nutritional and clinical outcomes among infants who had congenital heart surgery in harapan kita national cardiovascular centre (hkncc), jakarta, indonesia. the researchers use consecutive sampling to include eligible infants and obtain informed consent from the parent or legal guardian of infants who fulfilled the eligibility criteria. block randomization is done by a research assistant, and then the allocation is prepared using a sealed envelope to assign infants into hdf and sf groups. participants are then assessed by a multi-professional team and given enteral feeds based on local guidelines. routine follow-up is done at 2 weeks, 1 month, 2 months, and 3 months after the intervention to record weight, length, and any episode of complication or adverse events.

Eligibility criteria:
inclusion criteria: * patient of less than 1 year of age who underwent congenital heart surgery procedure in harapan kita national cardiovascular center * risk adjustment for congenital heart surgery (rachs) score 2-4 * patients who do not get exclusive breastfeeding due to any cause exclusion criteria: * history of prematurity (\<37 weeks gestational age) * formula intolerance or cow milk protein allergy * lethal chromosome abnormality * galactosemia * gastrointestinal malformation or obstruction * renal failure * liver disease * metabolic abnormalities * need for extracorporeal membrane oxygenation drop-out * patients who develop diarrhea for more than 5 days during the study period despite getting adequate therapy * patients who need prolonged total parenteral nutrition (e.g., gastrointestinal bleeding due to any cause, chylothorax, etc.) * patients with necrotizing enterocolitis during the study period

Keywords: anthropometry congenital heart disease infant formula nutritional status randomized controlled trial
the safety and efficacy of ibrutinib in refractory/relapsed autoimmune hemolytic anemia

Conditions: Refractory/Relapsed Autoimmune Hemolytic Anemia

Summary: this is an open-label, single-arm study to evaluate the safety and efficacy of ibrutinib in subjects with refractory/relapsed autoimmune hemolytic anemia.


Eligibility criteria:
inclusion criteria: * ecog ≤ 3 * age from 6 to 70. * diagnosed with waiha or maiha. * meets the criteria of relapsed / refractory aiha. * meets the criteria of dat-negative aiha without any other inherited or acquired hemolytic diseases, and previously treated effectively with glucocorticoids and rituximab. * signed informed consent. * organs in good function. exclusion criteria: * nursing woman * active bacterial, virus, fungal or parasitic infection, including hiv infection, hbsag and hbv dna positive, hcv dna positive, etc. * diagnosed with cold agglutinin disease or cold agglutinin syndrome or paroxysmal cold hemoglobinuria. * secondary aiha caused by drugs or infection. * received rituximab in 8 weeks before enrollment. * previously received treatment with btk inhibitor. * previously received organ or stem cell transplantation. * have a history of thrombosis or organ infarction. * diagnosed with an active stage of connective tissue disease. * have a history of lymphoproliferative tumors or any other malignant tumors. * have other inherited or acquired hemolytic diseases. * received low-molecular-weight heparin or warfarin within 1 week before enrollment or during the ibrutinib treatment. * received cyp3a4 enzyme inhibitors or inducers within 1 week before enrollment or during the ibrutinib treatment. * have a history of mental illness. * inability to understand or to follow study procedures.

Keywords: ibrutinib btk inhibitor autoimmune hemolytic anemia aiha
a study of upper arm rehabilitation in stroke survivors- astar

Conditions: Stroke; Upper Limb Injury; Rehabilitation

Summary: this feasibility study will explore the clinical effectiveness of additional upper limb therapy compared to standard care delivered to stroke survivors at sussex rehabilitation centre (src). randomization via sealed envelope will allocate treatment group to either routine care or upper limb training for self-management plus routine care. if randomized to upper limb training, a patient will undertake 10 therapy sessions with an instructor from the action for rehabilitation for neurological injury (arni) program during their hospital stay. the last two arni-led sessions will be filmed by a nurse/carer on either their own tablet/phone or an i-pad. participants in the arni group will be encouraged to continue doing their personalized exercises while in hospital and continued at home. the participants in the arni group will also be given a task-training board to take home. this randomized controlled trial will measure outcomes of each group over six months. each patient in the study will have upper limb physical measurements taken by a blinded research nurse (rn2) at baseline. research nurse (rn1) will gather data in a clinical report file from a weekly exercise diary completed by the patient or carer and well-being questionnaires. on discharge, rn2 will conduct upper limb measurements, collect completed hospital diaries and issue new ones to take4 home. rn1 will give a weekly phone call or text reminders so that patients to complete exercise diaries at home. at 6 months rn2 will do final measurements and complete patient questionnaires in an out patients clinic visit. the investigators aim to recruit 36 patients and anticipate 30(8.3%) will complete the 6 month follow-up. the study sponsor will be the university of sussex. however, as the study is run in rehabilitation unit in an nhs hospital, university hospitals sussex nhs trust will host the study.


Eligibility criteria:
inclusion criteria: * stroke survivors admitted to sussex rehabilitation centre * aged 18 years or over * have an upper limb affected by stroke * have capacity to consent to participate in the study * medically stable exclusion criteria: * aged under 18 years * amts \<8 * have a neurological deficit which does not involve upper limb * presence of a terminal illness with shortened life expectancy \<6 months.
early signs of altitude illness in patients with copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this study evaluates whether structured self-monitoring (ssm) by a symptom checklist in combination with a pulse oximeter worn at the wrist allows lowlanders with copd to accurately identify whether or not they will experience an altitude-related illness during altitude travel.

this study evaluates whether structured self-monitoring (ssm) by a symptom checklist in combination with a pulse oximeter worn at the wrist allows lowlanders with copd to accurately identify whether or not they will experience an altitude-related illness during altitude travel. after baseline evaluation at 760 m, patients will travel by bus within 3-5 h to the tuja ashu high altitude clinic at 3'100 m and stay there for 2 days. during this period, participants will perform ssm. they are instructed to report to study personnel if they fulfill predefined criteria for impeding altitude-related illness. a planned interim analysis will be performed after the first year of the study or after completion of study by 80 participants, whichever comes first to allow any necessary adaptations of the sample size or terminate the study early for futility or high accuracy of the index test.

Eligibility criteria:
inclusion criteria * male and female patients, age 18-75 yrs. * copd diagnosed according to gold, fev1 40-80% predicted, spo2 ≥92%, paco2 \<6 kpa at 760 m. * born, raised and currently living at low altitude (\<800 m). * written informed consent. exclusion criteria * copd exacerbation, very severe copd with hypoxemia at low altitude (fev1 \<40% predicted; oxygen saturation on room air \<92% or hypercapnia at 760 m). * other lung disease or disorder of control of breathing * comorbidities such as uncontrolled cardiovascular disease, i.e., unstable systemic arterial hypertension, coronary artery disease; previous stroke, internal, neurologic, rheumatologic or psychiatric disease that interfere with protocol compliance including current heavy smoking (\>20 cigarettes per day)

Keywords: altitude hypobaric hypoxia altitude-related illness prevention
effectiveness of prophylactic antibiotics to prevent post endoscopic retrograde cholangio pancreatography bacteremia in biliary obstruction patient

Conditions: Biliary Obstructive Disease Such as Choledocholithiasis; Benign Biliary Stricture; Peri-ampullary Cancer; Bile Duct Cancer Resectable; Klatskin Tumor

Summary: endoscopic retrograde cholangio-pancreatography (ercp) is advanced endoscopic technique that allows minimally invasive management of biliary and pancreatic disorders. however, the incidence of infectious complication of ercp is considerable. transient blood stream infection after ercp has been reported in a high ratio, up to 27% and post-ercp infection accounts for about 10% of the major complications associated with mortality. although prophylactic use of antibiotics is generally not recommend in all cases, debates about the prophylactic use of antibiotics continues and prophylactic use of antibiotics is recommend in case of ercp that incomplete biliary drainage is expected. in this study, researchers will use prophylactic antibiotics in patients with biliary obstruction who have high-risk of post-ercp bacteremia. antibiotics regimen is selected based on the data of our institution, and administered to patients before ercp procedure.


Eligibility criteria:
inclusion criteria: * patients with biliary obstructive disease (benign or malignant) * 19 year-old and older than 19 year-old exclusion criteria: * younger than 19 year-old * patients with leukocytosis (wbc ≥ 11,000/mm3) * body temperature ≥ 38 °c within 72 hours before ercp * history of antibiotics administration due to cholangitis, cholecystitis or sepsis within 72 hours before ercp * pregnancy women * patients with allergy to beta-lactam

Keywords: ercp prophylaxis antibiotics infection cholangitis
a study of docetaxel or docetaxel plus pf-3512676 to treat patients with advanced breast cancer.

Conditions: Breast Neoplasms

Summary: to assess the efficacy and safety of pf-3512676 administered in combination with docetaxel for the treatment of patients with advanced breast cancer.


Eligibility criteria:
inclusion criteria: * female patients with confirmed advanced breast cancer. * patients with her-2 negative disease with documented disease progression after (neo)adjuvant treatment with an anthracycline-based chemotherapy regimen. * patients with adequate general well-being, kidney and liver function. exclusion criteria: * patients that have any condition that could affect patients safety, interfere with trial results, or makes the patient inappropriate for inclusion into study. * patients who have had prior chemotherapy for advanced breast cancer. * patients of child-bearing potential who are unwilling to use contraception.
atrial fibrillation (af) clinic to improve the treatment of patients with atrial fibrillation.

Conditions: Atrial Fibrillation

Summary: * randomized controlled trial comparing specialized af clinic with 'care as usual' * hypothesis: treatment of af patients in the af-clinic by a nurse, specialised in af, using guideline-based dedicated software, under supervision of a cardiologist, is efficient, safe and not inferior to care as usual by a cardiologists.


Eligibility criteria:
inclusion criteria: * newly diagnosed atrial fibrillation exclusion criteria: * age \< 18 years * unwillingness to participate

Keywords: atrial fibrillation disease management program integrated chronic care program guideline stroke heart failure quality of life costs
the comparison of hemodynamic effects between remimazolam-remifentanil and propofol-remifentanil in patients undergoing laparoscopic cholecystectomy

Conditions: Acute Cholecystitis

Summary: this study is conducted to determine whether the occurrence of hypotension is reduced by the combined use of remimazolam and remifentanil compared to the conventional combination use of propofol and remifentanil. patients enrolled in the study are infused continuously with either propofol or remimazolam from the start of anesthesia to the end of surgery.


Eligibility criteria:
inclusion criteria: 1. patients 19 years of age or older 2. the american society of anesthesiologists classification 1-3 3. patients undergoing laparoscopic cholecystectomy at severance hospital exclusion criteria: 1. emergency surgery, 2. patients with heart disease or arrhythmias, 3. patients undergoing concurrent surgery other than laparoscopic cholecystectomy, 4. obesity (bmi\>30), 5. patients who were admitted on the surgery day, 6. foreigners, 7. illiteracy
the study of biological prosthetic heart valves with the "easy change" system

Conditions: Heart Valve Diseases

Summary: the study of new biological heart valves with the "easy change" system, including an assessment of the basic hemodynamic characteristics of the prosthesis, complications associated with valve implantation, and general mortality

the study of new biological heart valves with the "easy change" system, including an assessment of the basic hemodynamic characteristics of the prosthesis, complications associated with valve implantation, and general mortality. antithrombotic therapy after new biological valve prosthesis is studied. transesophageal ultrasound is used for assessment of aortic strain, left ventricular strain, and 3d reconstruction of implanted bioprosthesis. the quality of life of patients is assessed using sf36 questionnaire. heart failure after surgery is assessed by six-minute walking test and plasma bnp level.

Eligibility criteria:
inclusion criteria: 1. aortic valve disease requiring surgical disease patients without symptoms with severe aortic stenosis - indexed area of the opening less than 0.5 cm2 / m2, average gradient more than 40 mm rt. art; o patients who require coronary artery bypass grafting with moderate aortic stenosis - indexed area of the hole 0.5 - 1 cm2 / m2, the average gradient is more than 20 mm rt. art., regardless of symptoms;patients with symptoms of aortic stenosis, regardless of the severity of stenosis) 2. mitral valve disease requiring surgical disease exclusion criteria: 1. the need for prosthetics of two or more valves 2. patients with a decrease in lvef of less than 45%; 3. the presence of a competing disease or concomitant pathology that significantly affects the prognosis of quality of life or the likelihood of death 4. high pulmonary hypertension (sdj above 60 mm hg. art.); 5. the diameter of the ascending aorta is more than 45 mm; 6. unwillingness of the patient to participate in the study.