Kornimate/medical-research-clean huggingface dataset:
at home ammonia monitoring of inborn errors of ammonia metabolism

Conditions: Urea Cycle Disorders; Organic Acidemias; Fatty Acid Oxidation Disorder; Ammonia; Metabolic Disorder

Summary: the goal of this observational study is to learn if people with certain ammonia metabolism disorders will measure their ammonia levels at home. the main question it aims to answer is: • will participants measure their ammonia every day? participants will be asked to: * attend three in-person study visits at the clinic. * measure temperature, heart rate, and blood oxygen every day. * complete a short survey every day. * measure ammonia every day.


Eligibility criteria:
inclusion criteria: * confirmed ammonia disorder such as * ornithine transcarbamylase deficiency * systemic primary carnitine deficiency * type i citrullinemia * argininosuccinic aciduria * isolated methylmalonic acidemia * type ii citrullinemia * propionic acidemia * isovaleric acidemia * multiple acyl-coa dehydrogenase deficiency * pyruvate carboxylase deficiency * argininemia (arginase deficiency) * carbamoyl phosphate synthase i deficiency * dihydrolipoamide dehydrogenase deficiency * lysinuric protein intolerance * hyperornithinemia-hyperammonemia-homocitrullinuria * carnitine-acylcarnitine translocase deficiency * carbonic anhydrase va deficiency * n-acetyl glutamate synthetase deficiency * english literacy exclusion criteria: * incarcerated * presence of a non-inborn error of metabolism medical condition associated with abnormal ammonia metabolism (e.g., end stage liver disease). * unable to read in english
donor immune cell therapy for acute myeloid leukemia

Conditions: Acute Myeloid Leukemia

Summary: this study aims to introduce a new technology of donor nk cell infusion. nk cells defend against viruses and cancer cells in vivo whereas this effect declines in patiens with tumors. in this study, nk cells will be separated from donated peripheral blood or umbilical cord blood. eligible nk cells will be infused to patients with acute myeloid leukemia (aml). this new therapy will probably induce their sustained remission and reduce recurrences.

primary end point: to determine the rate of overall survival at 2 years of interventional cohort secondary end point: to determine the cumulative incidence of relapse at 2 years. to determine the rate of disease-free survival at 2 years. describe the safety and toxicity of donor nk cell infusion. study design: this study is a phase i clinical trial. 15 eligible aml patients will be enrolled sequentially to receive detached nk cells product during induction or consolidation therapy. refractory or relapsed patients and patients who achieved complete remission (cr) after induction therapy are included. they will receive anthracycline-based chemotherapy according to nccn guidelines. at the same time, cultured nk cells will be infused into patients after chemotherapy. anti-allergic therapy and prophylaxis of graft versus host disease (gvhd) will be given before infusion. treatment effect will be measured and adverse effect will be treated and documented after intervention.

Eligibility criteria:
inclusion criteria: * patients must have been diagnosed as acute myeloid leukemia in accordance with "chinese diagnosis and treatment guidelines of aml". those who achieved cr after chemotherapy are mainly included. refractory/relapsed aml can also be enrolled. * patients with normal heart function (ejection fraction ≥ 50%), normal liver function(alt and ast ≤ 2.5 times the upper limit of normal value, bilirubin ≤ 2 times the upper limit of normal value) and normal renal function with blood creatinine ≤ 3.0 mg/dl (≤ 260 µmol /l) can be enrolled. * patients will be required to sign an informed consent. exclusion criteria: * patients with severe infection or other malignant tumors. * women during pregnancy or lactation. * other patients deemed unsuitable by the investigator.

Keywords: natural killler cell acute myeloid leukemia
efficacy and safety of parecoxib 40mg vs. ketoprofen 100mg in the management of acute renal colic

Conditions: Pain

Summary: this is a multicenter, randomized, double blind, double dummy, comparative, active-controlled trial designed to assess the analgesic activity and safety of intravenous doses of parecoxib 40 mg relative to intravenous doses of ketoprofen 100 mg for the treatment of renal colic in outpatients presenting at emergency room settings. this trial is designed to show non-inferiority of parecoxib related to ketoprofen.


Eligibility criteria:
inclusion criteria: * patient male or female with a confirmed diagnosis of acute renal colic with moderate to severe pain according to the vas and categoric pain scales exclusion criteria: * the patient has significant renal or hepatic conditions other than uncomplicated kidney stones. * the patient has a history of clinically significant hypersensitivity to any nsaids, cyclooxygenase inhibitors, analgesics or sulfa medications which has a cross sensitivity to the medications used in this study.

Keywords: renal colic pain urinary tract colic
serum cysteine rich protein 61 and cystatin c for early detection of acute kidney injury in patients with heart diseases

Conditions: Acute Kidney Injury

Summary: acute kidney injury (aki) is defined as an absolute increase in serum creatinine ≥0.3 mg/dl (≥26.4 μmol/l), a percentage increase in serum creatinine ≥50% (1.5-fold from baseline), or a reduction in urine output (documented oliguria \ 6 hours) s.creatinine which is considered the gold standard currently for diagnosis of aki remains unchanged until 50% of kidney function falls down. it is affected by non-specific factors like diet, age, dehydration, muscle mass, gender, and drugs. there were evidences of the association between aki and acute coronary syndrome (acs); first, aki detection may be missed by cardiologists. physicians tend to disregard mild or transient serum creatinine elevation during hospital stay for acs, and they often attribute small serum creatinine increases to laboratory variations.

cystatin c (cysc), a cystatin protease inhibitor, is less affected by non-specific factors. when glomerular filtration rate (gfr) decreases, cysc begins to increase. cysc was recommended to be measured in addition to creatinine in gfr estimation. cysteine-rich protein 61 (cyr61) is a cysteine-rich secretory protein that promotes cell proliferation, adhesion, chemotaxis, embryonic development and neovascularization . previous studies have detected low expression level of cyr61 in normal adult kidney and high expression of cyr61 in ischemic rats and mice kidney, which suggests that cyr61 may be a potential biomarker for diagnosis of aki . cyr61 might possibly identify patients with more severe kidney injury, which would be very beneficial for early treatment of aki after

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years. 2. informed consent 3. patient with absolute increase in serum creatinine ≥0.3 mg/dl (≥26.4 μmol/l) or with percentage increase in serum creatinine ≥50% (1.5-fold from baseline) 4. patient with reduction in urine output (documented oliguria \ 6 hours) 5. patient with typical chest pain, ecg changes, echocardiogram positive finding exclusion criteria: 1. history of nephrectomy 2. patient with renal transplantation 3. patient with renal replacement therapy initiated before admission 4. patient with chronic kidney disease 5. patient on regular haemodialysis 6. patient known to be diabetic
multidisciplinary rehabilitation of children and adolescents after acute cancer treatment

Conditions: Cancer Survivors; Rehabilitation; Exercise Therapy

Summary: recent numbers display a 85% survival-rate in children after a very harmful disease such as cancer. however, the survivors still experience mild to severe side effects of the primary disease or treatment. a long time follow-up in the university hospital of ghent in children with cancer displays important long term side effects such as: reduced muscle strength; reduced endurance capacity; reduced exercise tolerance; fatigue; disturbed body composition with increased risk for obesity and/or diabetes and osteoporosis; and neuropathic damage and myopathy. these physical complaints have a significant impact on the activities and participation in daily living. the purpose of this interventional study is to create a rehabilitation program for children after acute cancer treatment. the goal is to minimalize the previous described long term side effects of the disease. the current study should allow us to determine the effects of the intervention at the level of functioning, activities and participation. in addition, we account for the environment and personal factors as described by the international classification of functioning, disability and health (icf-criteria). the study population consists of children between 8 and 11 years and adolescents of 12 to 21 years old. all participants receive a multidisciplinary treatment for 4 months, guided by a team which includes: oncologist, rehabilitation doctor, physical therapist, dietitian, psychologist, and occupational therapist. at the beginning of the multidisciplinary program, the participants receive psychoeducation, diet advice, tips for participation, fatigue, and psychological well-being. in general, the rehabilitation program focusses on reintegration at school and leisure activity. after the first assessment, an individually adjusted physical program consisting of strength and endurance training will be made. this physical program will be executed 3 times a week, 2 times guided by a physical therapist at the university hospital or at a private practice, and ones a week by themselves at home recorded by an activity tracker. follow-up is foreseen on monthly basis. participants will undergo assessment 3 times: 1) baseline (t0); 2) after 4 months treatment (t1); 3) after 1 year follow-up (t2). the purpose of this program is to encourage patients at risk for increasing their healthy habits, exercise and participation in order to decrease long-term (side) effects.


Eligibility criteria:
inclusion criteria: * between 6 months and 8 years post acute cancer treatment * off medical treatment * all possible cancer diagnosis, except for brain tumors and sarcomas exclusion criteria: * not able to participate for 3 consecutive weeks * not able to perform a maximal cardiopulmonary exercise test * unwilling to cooperate * relapse

Keywords: multidisciplinary rehabilitation cohort study childhood and adolescence
preoperative fluoroscopy guided hip articular branch blocks and analgesic outcomes following hip arthroscopy

Conditions: Surgery, Arthroscopic; Analgesia; Pain, Acute

Summary: arthroscopic hip surgeries are increasingly being performed as both diagnostic and therapeutic interventions. these procedures are considerably painful, thus requiring the proper pain management techniques in order to provide patient satisfaction and sufficient pain control. articular branch blocks have not been evaluated for their use in hip arthroscopy, but have potential advantages of blocking the sensory innervation of the entire hip joint, with minimal impact on motor innervation compared to alternative blocks. this current study aims to evaluate the efficacy of using preoperative fluoroscopic-guided blockade of articular branches of the femoral and obturator nerves for analgesic management of patients undergoing arthroscopy compared to a saline sham block. the utility of pre-operative hip articular branch block (abb) prior to hip arthroscopy will provide superior pain management postoperatively compared to a saline sham block. we hypothesize that the abb (articular branch block) will reduce the area under the nrs pain scores by time curve (auc) and decreased oral opioid milligram equivalent use in the first 24 hours post-operatively.


Eligibility criteria:
inclusion criteria: * presenting for hip arthroscopy (diagnostic or therapeutic) * pre-operative numeric rating score (nrs) for pain \<8 on a 0 to 10 scale where 0 is no pain and 10 is worst pain imaginable. exclusion criteria: * allergies to any of the study medications * anti-coagulation status (inr \> 1.1, pt or aptt \> 1.5 control) * history of hip arthroplasty * infection of hip * evidence of tumor * pregnancy * history of diabetes with hba1c \> 10% * prior history of hip articular branch blockade or hip articular branch prf ablation

Keywords: hip arthroscopy articular branch block
implementation for heart failure therapies post-discharge followed by cardiosignal at home

Conditions: Heart Failure

Summary: cardiosignal technology (mechanocardiography) could enable home follow-up after admission for acute heart failure, thus improving guidline-directed medical therapies for heart failure dose escalation while reducing the logistical constraints and stress associated with frequent hospital visits. the intended purpose is to detect signs of hf in adults (aged 18 years or older and \< 85 years)

cardiosignal is a smartphone-based innovation using the smartphone's built-in motion sensors (accelerometer and gyroscope) for measuring heart mechanical motion (seismocardiography and gyrocardiography) when placing the phone on the chest for one minute. innovation also includes cloud-based data analysis for heart motion signals. cardiosignal is a class iia medical device (software as a medical device) for detecting atrial fibrillation (afib) and measuring heart rate and soon detecting heart failure. cardiosignal provides accurate and actionable insights of heart health without the need for additional hardware for everyone and everywhere using their smartphone. relevant disease areas include atrial fibrillation, heart failure, and related conditions such as stroke and transient ischemic attack (tia). the innovation supports long-term monitoring and prevention efforts for high-risk populations, including patients with hypertension, diabetes, sleep apnea, cancer, and those with a history of cardiovascular disease as well as patients discharged after a surgical operation. the primary user groups are patients at home and healthcare providers at point-of-care. cardiosignal empowers patients to self-monitor heart health easily and affordably, enabling proactive care and improved outcomes across diverse populations, including elderly patients, chronic disease sufferers, and those awaiting specialist care or surgical procedures.

Eligibility criteria:
inclusion criteria: * patients admitted at emergency room for acute heart failure. * patients discharged from emergency room after an episode of acute heart failure. * either lvef\>40% or ≤40%, either known or assessed during the index hospitalization (however at least 1/3 of patients are required from each category). * bnp \> 200 pg/ml or nt-probnp \> 800 pg/ml * patients with connected smartphone. exclusion criteria: * patients \ 85 years. * pregnant women. lactating woman. * previous history of allergic asthma at an early age. * patients with a history of pulmonary embolism. * cardiorespiratory disorders which may be aggravated by the slight compression of the thorax. (patient with a pacemaker). * known allergies for: bisoprolol, ramipril, entresto, spironolactone, empagliflozine, dapagliflozine. * the participant's inability to adhere to study procedures or give informed consent.

Keywords: heart failure smartphone detection mechanocardiography
mindfulness-based crisis intervention for covid-19 frontline healthcare workers during covid-19

Conditions: Mindfulness; COVID-19; Healthcare Worker

Summary: the covid-19 outbreak is having an impact on the well-being of healthcare workers. previous reports on pandemics show that such an impact may last beyond the time of the outbreak. mindfulness-based interventions help healthcare professionals to reduce stress and may foster resilience and recovery, although they have never been tested in a context such as the current one. this single-arm trial explores the acceptability, safety and usefulness of an on-site, brief mindfulness-based intervention to reduce stress for front line health workers during a crisis.


Eligibility criteria:
inclusion criteria: * all frontline healthcare workers present in the ward at the time of intervention exclusion criteria: * extreme adverse events
visual perceptual learning for the treatment of visual field defect

Conditions: Visual Fields Hemianopsia; Hemianopsia, Homonymous

Summary: this study evaluates the efficacy of visual perceptual learning for the treatment of visual field defect caused by brain damage. half of participants will receive visual perceptual training using the nunap vision, while the other half will receive sham training using the nunap vision-c.


Eligibility criteria:
inclusion criteria: * age 19-80 years * brain damage-induced visual field defect * at least 6 months after brain lesion * minimum of 4 testing locations, where measured threshold ≤ 20db * verified visual pathway damage using ct or mri * k-mmse(korean mini mental status examination) score ≥ 24 * visual acuity equal or better than 20/40 * able to use the investigational device * patient/legally authorized representative has signed the informed consent form exclusion criteria: * unreliable humphrey visual field test (any of fixation loss, false positive, false negative ≥ 20%) * complete hemianopsia with sensitivity of the whole hemifield ≤ 3 db * epilepsy, photosensitivity, parkinson's disease * bilateral visual field defect * hemispatial neglect * ophthalmologic disorder that may interfere the trial * inability to discontinue psychostimulants such as methylphenidate, modafinil, and amphetamine. * candidate for carotid endarterectomy or stenting * received ophthalmologic surgery within 3 months, except for the cataract surgery * pregnant or breast feeding * participating in other clinical trial * any other condition that, in the opinion of the investigator, precludes participation in the trial

Keywords: visual field defect visual perceptual learning humphrey visual field
a phase 3, pivotal trial of vb-111 plus bevacizumab vs. bevacizumab in patients with recurrent glioblastoma (globe)

Conditions: Glioblastoma

Summary: the purpose of this pivotal, phase 3, randomized, multicenter study is to compare vb-111 plus bevacizumab to bevacizumab in adult patients with recurrent glioblastoma.


Eligibility criteria:
inclusion criteria: 1. first or second progression of glioblastoma; 2. measurable disease by rano criteria at progression; 3. patients ≥18 years of age; 4. patient may have been operated for recurrence. if operated: residual and measurable disease after surgery is required; 5. surgery completed at least 28 days before randomization; 6. an interval of at least 12 weeks between prior radiotherapy or at least 23 days from prior chemotherapy, 42 days from nitrosoureas and enrollment in this study; 7. adequate performance, i.e."karnofsky performance score" of at least 70%; 8. adequate renal, liver, and bone marrow function according to the following criteria: * absolute neutrophil count ≥1500 cells/ml, * platelets ≥ 100,000 cells/ml, * total bilirubin within upper limit of normal (uln), * aspartate aminotransferase (ast) ≤ 2.0 x uln, * serum creatinine level ≤ uln or creatinine clearance ≥ 50 ml/min for patients with creatinine levels above normal limits (creatinine clearance calculated by the cockcroft-gault formula, see appendix ii), * pt, ptt (in seconds) not to be prolonged beyond \>20% of the upper limits of normal. exclusion criteria: 1. prior anti-angiogenic therapy including vegf sequestering agents (i.e. bevacizumab, aflibercept, etc.) or vegfr inhibitors (cedirinib, pazopanib, sunitinib, sorafenib, etc.); 2. prior stereotactic radiotherapy; 3. pregnant or breastfeeding patients; 4. concomitant medication that may interfere with study results; e.g. immunosuppressive agents other than corticosteroids; 5. active infection; 6. evidence of significant cns haemorrhage i.e. ctcae grade 2 or above; 7. expected to have surgery during study period; 8. patients with active vascular disease, either myocardial or peripheral (i.e. acute coronary syndrome, cerebral stroke, transient ischemic attack or arterial thrombosis or symptomatic peripheral vascular disease within the past 3 months); 9. patients with known proliferative and/or vascular retinopathy; 10. patients with known liver disease (alcoholic, drug/toxin induced, genetic, or autoimmune); 11. patients with known active second malignancy other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer, and ductal or lobular carcinoma in situ of the breast. patients are not considered to have a currently active malignancy if they have completed anticancer therapy and have been disease free for greater than 2 years prior to screening; 12. patients testing positive to one of the following viruses: hiv, hbv and hcv within the last 6 months; 13. patients that have undergone major surgery within the last 4 weeks before enrollment; 14. patients who have received treatment with any other investigational agent within 4 weeks before enrollment.

Keywords: rgbm recurrent glioblastoma recurrent gbm
neural dynamics technique for the treatment of chronic radicular low back pain

Conditions: Low Back Pain; Sciatica

Summary: low back pain ( lbp) is a significant health problem which affects about 70%-80% of the population during the course of their life . the majority of lbp is resolved within 3 months; however, up to 40% of lbp becomes chronic. one subgroup of chronic lbp is patients with sciatica. sciatica is characterized by radiating pain to the buttock and lower limb, with or without low back pain. it has been shown in the upper limb that by positioning the contra-lateral arm in tension the investigators actually reduce tension in the ipsilateral arm. patients, who present with symptoms like sciatica, can benefit from this maneuver (neural dynamics techniques) that reduces tension through the contra-lateral leg. working hypothesis: compared with a placebo maneuver of the upper limb, the neural dynamics techniques will result in better rehabilitation of individuals with radicular lbp.

objectives: to evaluate the efficacy of neural dynamics techniques, using the contra-lateral leg, in the treatment of sub-acute/chronic low back pain with radiation to the leg. study methodology: eligible individuals will be assessed by a physiotherapist that will be blinded to the treatment allocation; treatment (either intervention or placebo) will be provided by a physiotherapist that will be blinded to the patient's assessment. the treated individuals and the referring physician will also be blinded to the treatment allocation;

Eligibility criteria:
inclusion criteria: * written consent * lbp with radiation to one leg, that lasts more than 6 weeks * abnormal response to slr test * with or without neurological signs exclusion criteria: * history of spinal surgery * patient with fuo * history of malignancies * patient with saddle anesthesia

Keywords: low back pain sciatica pain physiotherapy