Kornimate/medical-research-clean huggingface dataset:
study of the effect of omega3 on biomarkers of cardiac necrosis (ckmb and troponin i) and inflammation marker (crp) after elective percutaneous coronary intervention (pci)

Conditions: Coronary Arteriosclerosis

Summary: the purpose of this study is to investigate the effect of omega 3 on biomarkers of cardiac necrosis(ckmb and troponin i) and inflammation marker crp.

percutaneous coronary intervention (pci) has become the most common form of coronary revascularization worldwide. although pci is a safe procedure, it may have multiple risks including bleeding, coronary dissection, abrupt vessel closure, and myocardial necrosis. it is estimated that approximately 25% of patients undergoing pci have significant postprocedural creatinine kinase (ck)/creatinine kinase myocardial band (ck-mb) elevations and approximately 50% of patients have significant post-procedural troponin elevations. initially, it was felt these elevations were simple enzyme leaks with no long-term implications. now, several studies have demonstrated that periprocedural infarction is associated with short-, intermediate-, and long-term adverse outcomes, most notably mortality. pretreatment with antiplatelets such as aspirin and clopidogrel play an important role in reducing cardiovascular events (cv events) following pci. omega -3 polyunsaturated fatty acids (pufas) have antiplatelet effect. it may also improve response to aspirin and clopidogrel in low-response patients. this study is a randomized clinical trial (rct) evaluating the effect of omega 3 supplement \[with 400mg eicosapentaenoic acid (epa) and 200mg docosahexanoic acid (dha)\] on biomarkers of cardiac necrosis (ckmb and troponin i) in patients undergoing elective pci. eighty patients planed to do elective pci will be categorized into two groups. the first group will be received standard regimen for pci (aspirin, clopidogrel, and heparin) and the second group will be treated with standard regimen in addition to 3 gram omega 3 (12 hours before pci). blood samples will be drawn in all patients before and 8 and 24 h after intervention for cardiac biomarkers assessment (ck-mb, troponin i)and inflammation marker c-reactive protein (crp). major adverse cardiac events (mace) will be evaluated as a second endpoint.

Eligibility criteria:
inclusion criteria: * candidate of elective pci * treatment with aspirin at least 5 days before pci exclusion criteria: * high ckmb and troponin i level * cardiac bypass in recent 3 months * platelet count \< 70×10 9/l * sever chronic renal failure * active bleeding * treatment with glycoprotein iib/iiia inhibitors during pci * treatment with bivalirudin during pci * sensitivity to aspirin and clopidogrel

Keywords: elective percutaneous coronary intervention hs-crp ckmb and troponin i
understanding how anaesthesia affects ect outcomes

Conditions: Depression

Summary: this study will examine how anaesthetic technique affects ect outcomes. specifically, the investigators will examine how: 1) the time interval between anaesthetic and ect stimulus, and 2) the ventilation rate before ect stimulus, impacts on the quality of the eeg (this is a recording of brain activity during ect and is used to judge the quality of a seizure and to guide individual patient dosing).

this study aims to examine how the time interval between administration of anaesthetic agent and ect stimulus delivery impacts upon measures of eeg quality (seizure quality).

Eligibility criteria:
inclusion criteria: * patients treated with a course of ect exclusion criteria: * use of non-standard anaesthetic agents in ect (e.g. ketamine)

Keywords: electroconvulsive therapy anaesthesia
opportunstic hepatitis c virus treatment

Conditions: Hepatitis C; Substance Use Disorders

Summary: the project will assess the effect of opportunistically treating hepatitis c virus (hcv) infection immediately when hcv-infected people who inject drugs are hospitalized for acute care in psychiatric, interdisciplinary specialized drug treatment or somatic wards. we will compare this approach with the current standard of care (soc), which is referral to the outpatient clinic at the medical department following discharge.

the overall objective is to show that opportunistic and immediate administration of hcv treatment is more efficient compared to referral-based soc. the specific objectives are: 1) to compare the intervention and soc groups with regards to treatment completion, treatment uptake and virologic response ; 2) to assess the rate of reinfection after successful hcv treatment; and 3) to assess the frequency of resistant associated substitutions before and after virologic treatment failure. we will use a stepped wedge design and include patients in 7 clusters following randomization of the cluster to the immediate treatment, physicians at the participating wards will be notified in writing that for the next time period patients diagnosed with hcv infection should be treated immediately. in addition, lectures presenting the opportunistic approach will be given and the department of microbiology will add a brief text to the result of hcv rna testing reminding about the opportunistic approach. in the medical and the psychiatric departments, consultants from the departments of infectious diseases or gastroenterology will prescribe immediate treatment. in the departments that provide addiction treatment, local physicians will prescribe treatment. treatment will be prescribed in accordance with current norwegian treatment recommendations. the intensity of care after discharge will be individualized at the discretion of the treating physician.

Eligibility criteria:
inclusion criteria * above 18 years of age * hcv rna positive * inpatient at participating ward * signed informed consent must be obtained and documented according to national and local regulations exclusion criteria: * pregnancy or breastfeeding. * in involuntarily health care. * ongoing treatment of hepatitis c. * current participation in another trial that might affect the current study. * any reason why, in the opinion of the investigator, the patient should not participate (e.g. not able to comply with study procedures).
long term follow-up observational study in patients treated with gene-modified t-cell therapy

Conditions: Relapsed or Refractory Multiple Myeloma

Summary: this is a prospective long-term follow-up (ltfu) study to evaluate the long-term safety and survival benefit for patients who received at least one of carsgen's gm t cell product in a clinical trial or as a commercially available product. in this study, patients will be followed for up to 15 years after last gm t-cell infusion for the evaluation of delayed adverse events (aes), vector persistence, potential risk for integration, and survival time due to gm t-cell exposure.

as recommended by health authorities guidelines for human gene therapy products containing an integrated transgene, during the ltfu for 15 years after infusion, the information of the enrolled patients will be collected, including medical history, physical and laboratory-related examination data, aes, survival information, etc. aes recorded will include new malignancy, new or exacerbation infection, new or exacerbation neurological disease, new or exacerbation autoimmune disease etc. samples will be obtained according to the schedule of activities, and laboratory tests will be conducted or preserved for future use. all participants are recommended to be followed at least every six months for the first 5 years, and annually from the 6th year until at least 15 years or until informed consent withdrawal, loss to follow-up, or death, whichever occurs first.

Eligibility criteria:
inclusion criteria: - 1. all patients who have received at least one gm t-cell infusion in the parent clinical study or in the post-approval setting. 2. patients must be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol. for patients incapable of providing consent, the signed icf of their legally accepted guardians must be obtained. exclusion criteria: * there are no specific exclusion criteria for this study.
transpire: lung injury in a longitudinal cohort of pediatric hsct patients

Conditions: Hematopoietic Stem Cell Transplant (HSCT); Diffuse Alveolar Hemorrhage; Thrombotic Microangiopathies; Interstitial Pneumonitis; Bronchiolitis Obliterans

Summary: hematopoietic stem cell transplant (hsct) is an effective but toxic therapy and pulmonary morbidity affects as many as 25% of children receiving transplant. early pulmonary injury includes diffuse alveolar hemorrhage (dah), thrombotic microangiopathy (tma) interstitial pneumonitis (ips) and infection, while later, bronchiolitis obliterans is a complication of chronic gvhd associated with severe morbidity and mortality. improved diagnosis and treatment of pulmonary complications are urgently needed as survival after hsct improves, and as hsct is increasingly used for non-malignant disorders such as sickle cell disease. currently, there are large and important gaps in the investigator's knowledge regarding incidence, etiology and optimal treatment of pulmonary complications. moreover, young children unable to perform spirometry are often diagnosed late, and strategies for monitoring therapeutic response are limited. this is a prospective multi-institutional cohort study in pediatric patients undergoing allogeneic hematopoietic stem cell transplantation (allohsct). assembly of a large prospective uniformly screened cohort of children receiving hsct, together with collection of biological samples, will be an effective strategy to identify mechanisms of lung injury, test novel diagnostic strategies for earlier diagnosis, and novel treatments to reduce morbidity and mortality from lung injury after transplant.


Eligibility criteria:
inclusion criteria: * subjects ≤ 24 years of age undergoing allogeneic or autologous hsct. exclusion criteria: * subjects over 24 years of age.
a study comparing subcutaneous mircera and darbepoetin alfa for maintenance treatment of anemia in kidney transplant recipients.

Conditions: Anemia

Summary: this two arm study will compare the efficacy and safety of subcutaneous mircera versus darbepoetin alfa for the maintenance of hemoglobin levels in kidney transplant recipients with chronic renal anemia. patients currently receiving maintenance treatment with darbepoetin alfa will be randomized either to receive 4-weekly injections of mircera with a starting dose (120, 200 or 360 micrograms subcutaneously) derived from the dose of darbepoetin alfa they were receiving in the 2 weeks preceding study start, or to stay on 2-weekly darbepoetin alfa therapy. the anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \> or = 18 years of age; * kidney transplant recipients with stage 3 or stage 4 chronic kidney disease; * functioning graft of \> 6 months and \< 10 years after kidney transplantation, with no signs of acute rejection; * stable maintenance subcutaneous darbepoetin alfa therapy every 2 weeks. exclusion criteria: * transfusion of red blood cells during previous 2 months; * poorly controlled hypertension; * significant acute or chronic bleeding; * need for dialysis therapy expected in next 6 months.
pricing interventions based on energy content in restaurants

Conditions: Obesity; Healthy Diet; Eating Behavior

Summary: the goal of this clinical trial is to examine the impact of price decreases based on energy content in a full-service restaurant on immediate dietary consumption (in terms of kilocalories (kcals), sugar, fat, and salt intake) and dietary consumption the rest of the day following the intervention; and whether the intervention effects differ based on socioeconomic position (sep). participants will be asked to visit the restaurant twice. at visit 1, participants will receive a control study menu with the existing pricing structure of the restaurant. at visit 2, participants will receive the same study menu with the pricing intervention introduced. for comparative purposes a smaller subgroup of participants will receive the control menu at both visit 1 and 2 to allow the researchers to estimate whether any pre-post changes occur in the absence of a pricing intervention (and whether change differs by sep).


Eligibility criteria:
inclusion criteria: * uk resident, aged 18 and older, fluent in english, have an out-of-home meal at least once a month and have no dietary allergies exclusion criteria: * no further exclusion criteria as it is a real-world study
pedicare health equity intervention in high-risk neuroblastoma

Conditions: Neuroblastoma; High-risk Neuroblastoma; Pediatric Cancer; Disparities; Financial Stress; Poverty

Summary: this is a randomized phase ii trial evaluating the addition of the pediatric cancer resource equity (pedicare) health equity intervention to usual supportive care for poverty-exposed children with newly diagnosed high-risk neuroblastoma. the names of the intervention groups in this research study are: * usual supportive care * pedicare + usual supportive care

this is a randomized phase ii trial evaluating the addition of the pediatric cancer resource equity (pedicare) health equity intervention to usual supportive care for poverty-exposed children with newly diagnosed high-risk neuroblastoma. participants will be randomized into one of two groups: usual supportive care vs. pedicare + usual supportive care. randomization means a participant is placed into a group by chance. participation in this research study is expected to last 6-months. it is expected about 130 people will participate in this research study.

Eligibility criteria:
inclusion criteria: * patient must have a new diagnosis of high-risk neuroblastoma. * patient must be enrolled on apec14b1 and must have consented to future contact on apec14b1. * patient must be enrolled on anbl2131. * patient aged 0-17 years at the time of consent to anbl2131. * patient must have opted-in to embedded optional anbl2131 household survey. * family screened positive for hmh or low-income on anbl2131 household survey. \* * patient has not yet initiated induction cycle 3 on anbl2131. * patient being treated at a u.s. site. * patients of all languages are eligible to participate. * eligibility based on household survey will be determined by central study team review. hmh exposure will be operationalized as the report of at least one of the following four concrete resource insecurities: (1) food insecurity, (2) housing insecurity, (3) utility insecurity, (4) transportation insecurity. low-income will be defined as reported annual household income of less than 200% federal poverty level (fpl). exclusion criteria: -patient has transferred to anbl1531 arm e.

Keywords: neuroblastoma high-risk neuroblastoma disparities pediatric cancer financial stress poverty
the movement control training associated with conventional physical therapy is more effective than conventional physical therapy alone in pain and functional performance?

Conditions: Patellofemoral Pain Syndrome

Summary: assess pain, performance function, hip and knee strength and kinematics of trunk and lower limbs during single leg hop test after movement control training associated to hip and knee muscle strengthening.


Eligibility criteria:
inclusion criteria: * sedentary women, * previous knee pain last 3 months in at least two of the following activities: sitting for long periods, walk up or down stairs, squat, running and jumping exclusion criteria: * lower limb surgery, * patella displacement * knee instability * heart or locomotor disorders which might influence the evaluation
prevalence of sarcopenia and undernutrition in patients with cirrhosis and abdominal hernia

Conditions: Cirrhosis; Sarcopenia; Malnutrition; Hernia, Abdominal

Summary: the study evaluates whether sarcopenia influences the prevalence of abdominal hernias in patients with cirrhosis.

sarcopenia is a common condition in patients with cirrhosis, with a prevalence of around 50%. it is unknown if the presence of sarcopenia may influence the prevalence of abdominal hernias in this group of patients. clinical, nutritional and radiological evaluation will be performed in two groups of cirrhotic patients to evaluate this hypothesis.

Eligibility criteria:
inclusion criteria: * ≥ 18 years * previous diagnosis of cirrhosis exclusion criteria: * acutely decompensated cirrhosis * other chronic diseases in advanced stage (e.g. cardiac failure, chronic obstructive pulmonary disease, cancer) * cognitive impairment, delirium, non-controlled psychosis

Keywords: cirrhosis sarcopenia malnutrition inguinal hernia umbilical hernia undernutrition
a study to evaluate ferumoxytol for the treatment of iron deficiency anemia (ida) in pediatric subjects

Conditions: Iron Deficiency Anemia

Summary: this is a phase 3, randomized, open-label, multicenter, study in male and female pediatric subjects (2 years to \<18 years of age) with ida, or felt by their clinician to be at risk of developing ida. this study allows for enrollment of subjects with ida regardless of etiology, except for ckd subjects (pediatric ckd subjects are being studied in a separate ferumoxytol protocol).

subjects will be randomized to treatment in a 2:1 ratio (ferumoxytol: iron sucrose) and stratified by age group (2 to \<6 years; 6 to \<12 years; and 12 to \<18 years). subjects will receive one of the following treatment regimens: • ferumoxytol: 7 mg fe/kg iv (maximum 510 mg/dose) x 2 doses, the first dose administered on day 1 and the second 2 to 8 days later. or • iron sucrose (venofer®): 4 mg fe/kg iv (maximum 200 mg/dose) x 5 doses, the first dose on day 1 and subsequent doses administered at least once per week and up to 3 times/week. all subjects will be monitored at the study site through at least 1 hour after the completion of each infusion of study drug. assessment of blood hgb concentrations, adverse events, and other safety assessments will be performed through study week 5.

Eligibility criteria:
inclusion criteria: 1. male or female 2 years to \<18 years of age at time of consent 2. has ida defined as: 1. hemoglobin (hgb) \<11.0 g/dl and 2. any one or more of the following: * transferrin saturation (tsat) \<20% * ferritin \<100 ng/ml 3. documented history of unsatisfactory oral iron therapy or in whom oral iron cannot be tolerated, or for whom oral iron is considered medically inappropriate exclusion criteria: 1. known hypersensitivity reaction to any component of ferumoxytol or iron sucrose 2. history of allergy to intravenous (iv) iron 3. history of ≥2 clinically significant drug allergies 4. subjects with ckd (defined as egfr of \<60 ml/min/1.73 m2 or a requirement for chronic hemodialysis or peritoneal dialysis during screening) 5. low systolic blood pressure (bp) (age 1 to 9 years \<70 + \[age in years x 2\] mmhg, age 10 to 17 years \<90 mmhg) 6. hgb ≤7.0 g/dl 7. serum ferritin level \>600 ng/ml

Keywords: ida anemia pediatrics ferumoxytol iron sucrose
observance of continuous positive pressure for the treatment of obstructive sleep apnea syndrome

Conditions: Obstructive Sleep Apnea Syndrome; Continuous Positive Airway Pressure; Adherence; Perception and Beliefs

Summary: moderate to severe obstructive sleep apnea syndrome (osas) (hai hypopnea apnea index ≥ 15) is a common pathology, which affects 6 to 17% of the general population. the alaska study, which involved 480,000 apneic patients newly fitted with cpap, showed that 76.9% of patients were still under treatment for one year, 62.9% after two years, and 52.3% after three years. all patients who recently diagnosed with osas in the sleep disorder unit (unity de pathologies du sommeil et de la vigilance, chu d'amiens-picardie, france) and who are requiring cpap will be included. on the day of their hospitalization for the implementation of the cpap therapy, patients will answer validated questionnaires to assess their level of motivation and adherence to the initiation of treatment but also to assess their knowledge and understanding of the disease and its treatment. these questionnaires will be repeated at the four-month and one-year follow-up consultations (+/- 21 days). the aim of the study is to identify the prognostic factors of adherence to cpap, leading to a better understanding and management of patients with sleep apnea syndrome.


Eligibility criteria:
inclusion criteria: * adult patient (≥ 18 years old) * diagnosis of moderate to severe obstructive sleep apnea syndrome osas (ahi ≥ 15) by polygraphy or polysomnography performed in our sleep disorder unit * requiring cpap therapy * informed consent exclusion criteria: * patient previously treated with cpap therapy * psychiatric illness destabilized * unstable medical condition (i.e. copd exacerbation, acute cardiac dysfunction, etc.) * planned obesity or ent surgery (because cpap treatment is planned for a short period) * central or mixed apnea syndrome * patient under 18 years old * pregnant, parturient or breastfeeding woman * patient under guardianship, curators or deprived of liberty * patient participating in another research including an exclusion period still in progress at the pre-inclusion.

Keywords: obstructive sleep apnea syndrome continuous positive airway pressure adherence perception and beliefs
prevention of perioperative pulmonary complications by lung recruitment during laparoscopic surgery

Conditions: Perioperative Complication; Hypoxia

Summary: perioperative pulmonary complications such as atelectasis, hypoxemia, and pneumonia after ventilatory management during general anesthesia have a negative impact on patient outcomes. the possibility of reducing perioperative pulmonary complications by lung recruitment, which uses positive pressure to prevent alveolar collapse, has been reported. although laparoscopic surgery, which has been widely performed in recent years, can reduce the invasiveness of the operation, it is prone to alveolar collapse due to increased abdominal pressure and diaphragm elevation. the purpose of this study is to verify whether the lung recruitment during laparoscopic surgery in trendelenburg head-down position prevents hypoxemia due to lung collapse.

the multi-center rct will enroll 80 patients who have laparoscopic surgery in trendelenburg head-down position. informed consent will be obtained for study subjects who meet the selection criteria, and the subjects will be enrolled in electronic data capture and randomized into two groups. patients will be admitted to the operating room for induction of anesthesia and tracheal intubation. in the control group, mechanical ventilation will be performed according to the initial settings and protocols. in the intervention group, after intubation, the ventilator will be initially set up, and the first pulmonary recruitment will be performed immediately after the start of the laparoscopy, followed by recruitment every 30 minutes until the end of the laparoscopy.

Eligibility criteria:
inclusion criteria: * patients undergoing low head laparoscopic surgery who are expected to be laparoscopic for more than 2 hours exclusion criteria: * lateral or supine position * bmi \> 35 * one-second rate \<70%, %vc \<80%, obstructive, restrictive, with bra * cardiovascular disease (nyha iii or higher) * intracranial hypertensive disease * emergency surgery * pregnancy * glaucoma * patients judged unsuitable by the anesthesiologist in charge

Keywords: perioperative pulmonary complications lung recruitment laparoscopic surgery