Kornimate/medical-research-clean huggingface dataset:
measuring the metabolic cost of fever

Conditions: Child; Critical Illness; Fever

Summary: fever is part of the body's immune response, often triggered by infection. fever is commonly treated with medicines such as paracetamol, mainly because people feel unwell with fever. however fever does have a role in fighting infection: it enables the rest of the immune system to function more efficiently, and may directly stop bacteria and viruses from multiplying. in most cases however treating fever does not matter because the rest of the immune system can cope well enough to fight the infection (with or without additional treatment, like antibiotics). in critically ill patients however any advantage in the fight against infection may be crucial. in a large observational study of adult patients in the intensive care unit, patients who developed an early fever with temperature between 38.5-39.5 degrees c fared relatively better than patients who were colder. so it is possible that in critical illness fever may be beneficial. however in critical illness the body does have limited energy resources. in order to raise the body temperature energy is required. however the investigators do not know how much energy is required to generate a fever in critically ill children. this study will aim to try and measure the energy required to generate a fever in a critically ill child. the investigators will measure energy expenditure directly in children admitted to the intensive care unit by measuring the levels of oxygen and carbon dioxide they breathe in and out (a method called indirect calorimetry). this will enable the investigators to judge whether the benefits of a fever can be justified by the energy costs in the energy depleted state that is critical illness.


Eligibility criteria:
inclusion criteria: - all children on the paediatric intensive care unit at great ormond street hospital who 1. are likely to or have developed a fever (suspected infection, following trauma, post major surgery) 2. are over 10kg (approx 1 year of age) 3. are invasively ventilated exclusion criteria: - children who 1. have a brain injury, where active temperature control may be instituted 2. patients post cardiac surgery 3. patient with or at risk of cardiac arrhythmias 4. patients post cardiac arrest 5. patient with refractory status epilepticus 6. children with a greater than 5% leak around the endotracheal tube 7. children with a fraction of inspired oxygen \>0.6
neural predictors of social emotion regulation training

Conditions: Emotions; Rumination

Summary: the purpose of this study is to investigate the basic psychological and neural mechanisms underlying the social regulation of emotion - that is, how one person's actions can impact, or regulate - the emotions of another person - and how this ability changes with practice. as such, this study is not designed to directly address clinical health outcomes and provide no treatment or intervention.

prior research has demonstrated that helping others regulate their emotions has benefits for the support provider. but little is known about the basic brain mechanisms underlying this ability or how this ability can change with practice. to address these questions, this study has two parts. in the first, functional magnetic resonance imaging (fmri) is used to gain insight into the brain systems involved in helping others regulate negative emotions by comparing them to the brain systems involved in regulating the participants' own negative emotions. in the second part, participants engage in three weeks of structured practice, or training, in either socially regulating others' emotions or in self-regulating their own emotions. the investigators predict that helping others regulate their emotions will involve many of the same brain regions implicated in regulating one's own emotions, in addition to regions involved in perspective taking and the reward of helping others. further, when relating the brain data from part 1 to the regulation practice data from part 2, the investigators expect that individuals who in part 1 show greater activity in brain regions supporting either social or self-regulation may be more likely in part 2 to show corresponding improvements in regulation performance. the results of these studies are intended to lay the groundwork for future studies investigating the social regulation of emotion in older adults and clinical populations for whom social support can be beneficial.

Eligibility criteria:
inclusion criteria: * native english speaker * right handed exclusion criteria: * current or past history of neurological or psychiatric illness * use of psychoactive drugs * individuals who have metal devices or implants that cannot be removed from their body (e.g., piercings, pacemakers, copper intrauterine devices (iuds)) * pregnant women
magnetic resonance imaging (mri) study of the hippocampus after infarction in the territory of the middle cerebral artery

Conditions: Ischemic Stroke

Summary: the purpose of this study is to observe delayed neuronal death of hippocampus after middle cerebral artery infarction in human beings.

40 patients with middle cerebral artery infarction and 40 healthy volunteers will be observed. all of them will receive mri scan and the assessment of the neuropsychological function (mmse, avlt, hamd) intending to observe delayed neuronal death of hippocampus after middle cerebral artery infarction in human beings.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of middle cerebral artery infarction * at least six months from the stroke * must be able to measure his(her) neuropsychologic function (by mmse, avlt) exclusion criteria: * unable to undergo examinations due to disturbances of consciousness or medical conditions * severe dementia, apraxia, disturbances of sensation or perception * serious complications including severe heart failure, hepatic dysfunction, renal insufficiency,or shock * parkinson's disease, malignant tumor, autoimmune diseases

Keywords: middle cerebral artery infarction chronic stage hippocampal volume mri mrs neuropsychologic assessment
the phocus trial: implementation of pharmacogenomic testing in oncology care

Conditions: Gastrointestinal Cancer; Head and Neck Cancer; Dihydropyrimidine Dehydrogenase Deficiency; UGT1A1 Gene Mutation; Breast Cancer

Summary: doctors leading this study hope to find out if giving study participants' genetic information to cancer care providers will help personalize chemotherapy dosing decisions and decrease common chemotherapy side effects. doctors leading the study will collect genetic information from study participants using pharmacogenomics/genotyping. pharmacogenomics is the study of how the differences in our genes can affect our unique response to medications. this is a randomized study, which means that participants in this study will be randomly assigned (as if "by flip of a coin") to one of two different groups: a "pharmacogenomics group" or "control group".


Eligibility criteria:
inclusion criteria adult patients receiving oncology care at the university of chicago medical center, and for whom treatment with a fluoropyrimidine and/or irinotecan is planned are eligible. individuals of all genders, races and ethnic groups are eligible for this trial. there is no bias towards race, sex, or gender in the clinical trial outlined. exclusion criteria 1. subjects who have previously been exposed to the planned chemotherapy agent at any time (fluoropyrimidine and/or irinotecan). 2. subjects enrolled in an investigational trial which would preclude dose modifications of fluoropyrimidine and/or irinotecan chemotherapies. 3. subjects who have undergone, or are being actively considered for, bone marrow, liver or kidney transplantation. 4. subjects with a history of or active blood cancer (e.g., leukemia). 5. chronic kidney disease, as defined by glomerular filtration rate (gfr) \< 30/ml/min/1.73m2, due to the risk of decreased drug excretion. 6. liver dysfunction, as defined by the following laboratory values, due to the risk of decreased drug metabolism: total bilirubin more than 1.5 mg/dl, aspartate aminotransferase (ast) and alanine transaminase (alt) more than 2.5 x upper limit of normal\*. (\*ast and alt more than 5 x upper limit of normal if hepatic metastases are present). 7. subjects who have previously or are currently enrolled in another institutional pharmacogenomic genotyping study, or are known to have previously undergone pharmacogenomic genotyping for the gene(s) of interest via another commercial or other means. 8. inability to understand and give informed consent to participate.

Keywords: pharmacogenomics
pneumocell - conjugated pneumococcal vaccination in patients with immunoglobulin g-deficiency

Conditions: IgG Deficiency

Summary: the aim is to study the immune response to conjugated pneumococcal vaccination (prevenar13) in immunoglobulin g-deficient patients and healthy controls. our hypothesis is that the antibody response will be impaired in patients as compared with controls. in contrast, we postulate that the cellular immune response will be intact.

ten patients with immunoglobulin g1 and/or immunoglobulin g2 deficiency will be enrolled together with 10 age and sex- matched controls. blood-samples will be drawn at base-line and after 1, 2 and 4 weeks post-vaccination. serum will be analyzed for opsonophagocytic antibodies. peripheral blood monocytic cells (pbmcs) will be isolated, frozen and later analyzed for all time-points simultaneously. pbmcs will be stimulated with vaccine-antigens for 3-5 days and cellular activation markers will be measured together with cytokines (interferon-gamma, interleukin (il)-5, il-13, il-10, il-17, il-22). in addition, levels of antimicrobial peptides in nasal fluid will be measured at baseline and after 4 weeks post-vaccination.

Eligibility criteria:
inclusion criteria: * immunoglobulin gamma-deficiency: immunoglobulin gamma 1-deficiency \< 2,8 g/l and/or immunoglobulin gamma 2-deficiency \< 1,15 g/l * age 18-65 exclusion criteria: * immunoglobulin gamma-substitution for 6 months prior to study inclusion * prevenar7 or prevenar13 given prior to study inclusion. * pneumovax given during a 2 year period prior to study inclusion * pregnancy or planning to become pregnant during the study period (4 weeks) * taking part in another clinical study involving drugs or vaccinations during the study period (4 weeks). * taking systemic steroids, non steroidal anti inflammatory drugs (nsaid) or immunosuppressive drugs. * being allergic to any substance in the vaccine. * acute and ongoing disease with high fever. * thrombocytopenia (\< 100x109/l). * coagulopathy * breastfeeding a baby * the healthy controls should not have any disease with effects on the immune-system

Keywords: opsonophagocytic antibodies cellular immunity vaccine immunity antimicrobial peptides
video call assisted assessment of acute stroke

Conditions: Stroke; Cerebrovascular Disorders; Brain Diseases; Nervous System Diseases; Vascular Diseases; Central Nervous System Diseases

Summary: this study aims to investigate whether a live stream video between the on-call neurologist and the emergency medical technicians can increase feasibility and performance of symptom-based prehospital stroke scales.

treatment of stroke with either thrombolysis or thrombectomy is highly time-dependent (administration within 4.5 hours and 24 hours from symptom onset, respectively), and morbidity and mortality increase with time from symptom onset to treatment. hence, prehospital evaluation and transport must be as accurate and rapid as possible in order to minimise time to treatment. different triage and transport paradigms for patients with suspected stroke are being investigated and multiple stroke scales have been coined in order to examine patients suspected of stroke in a prehospital setting. however, performance and feasibility vary greatly in different validation studies suggesting that those outcomes are greatly dependent on other factors i.e. acceptance amongst stakeholders, implementation process, patient segment etc. some recent studies have shown promising results using video solutions between emergency medical services (ems) personnel and on-call neurologist in examining patients suspected of stroke in the prehospital phase. the investigators will perform this trial to examine whether a video call assisted assessment of patients suspected of stroke in a prehospital setting can increase feasibility and performance of symptom-based prehospital stroke scales.

Eligibility criteria:
inclusion criteria: * suspected stroke within 24 hours from onset (confirmed with prehospital stroke 1 decision tool) * age \>18 years exclusion criteria: * suspected stroke more than 24 hours ago * in-hospital stroke or private transport to hospital * unconsciousness defined as glasgow coma score (gcs) ≤ 8 (as they cannot be rated)
vascular reactivity in metabolic syndrome and diabetic patients using diffuse optical spectroscopy

Conditions: Diabetes Mellitus

Summary: metabolic syndrome is a highly prevalent condition that is comprised of several major clustering factors that increase the risk for developing cardiovascular disease. diffuse optical spectroscopy is a non-invasively measure can show changes in the microvasculature of human. diffuse optical spectroscopy measures the optical absorption and scattering properties of near-infrared light in tissues such as muscle in order to quantify the absolute concentration of oxygenated and deoxygenated hemoglobin, water, and lipids. it provides quantitative and functional information on the microvasculature related to tissue perfusion, metabolic changes, and indicators of tissue damage.

the researchers can use diffuse optical spectroscopy to monitor changes in the microvasculature of patients with metabolic syndrome and diabetic mellitus, and patients with diabetic peripheral and autonomic neuropathy, versus non-diseased and predisposed subjects by evaluating the changes in oxygen metabolism. the diffuse optical spectroscopy measure the changes in the concentration and oxygen saturation of hemoglobin in the microvasculature under stress, for example, during exercise and in response to changes in breathing habits. the sensitivity of diffuse optical spectroscopy to tissue hemodynamics provides an impressive arena of useful clinical applications..

Eligibility criteria:
inclusion criteria: * adult ages of 45 to 75 * have been clinically diagnosed with type ii diabetes mellitus * have a diagnosis of metabolic syndrome exclusion criteria: * taking light-sensitive drugs for use in photodynamic therapy * pregnant

Keywords: metabolic syndrome
adjuvant gemcitabine plus oxaliplatin versus gemcitabine plus cisplatin for completely resected stage ib/ii/iiia nsclc

Conditions: Lung Cancer

Summary: oxaliplatin has a more manageable toxicity profile than cisplatin, with no renal toxicity and a lower incidence of hematological and gastrointestinal toxicities. the combination of gemcitabine-oxaliplatin is attractive in nsclc patients as it may improve the therapeutic index. given the potential advantages of oxaliplatin and th finding that the addition of chemotherapy improves survival in the postoperative adjuvant setting, we conduct a phase ii trial to compare adjuvant gemcitabine-oxaliplatin with gemcitabine-cisplatin in patients with completely resected stage ib, ii or iiia nsclc

this study is a randomized phase ii study. patients are randomized to 1 of 2 treatment arms: patients receive adjuvant chemotherapy with gemcitabine-oxaliplatin or gemcitabine-cisplatin. chemotherapy should be started within 8 weeks after complete surgical resection. patients are followed every 3 months for 2 years, every 6 months for 3 years. gemcitabine-oxaliplatin (gemox) chemotherapy: gemcitabine (1,250 mg/m2)+oxaliplatin (85 mg/m2) is given on day 1 and 15 q 4weeks. maximum 4 cycles. gemcitabine-cisplatin (gemcis) chemotherapy: gemcitabine (1,250 mg/m2) + cisplatin (40 mg/m2) is given on day 1 and 15 q 4weeks. maximum 4 cycles.

Eligibility criteria:
inclusion criteria: 1. histologic diagnosis of non-small cell lung cancer. 2. presence of pathological stage ib, ii or iiia, according to the american joint committee on cancer (ajcc). 3. completely resected tumor at ncc hospital. 4. no prior tumor therapy (radiotherapy, chemotherapy, immunotherapy, or any other type of tumor therapy). 5. performance status of 0-1 on ecog scale. 6. at least 18 years old 7. patient compliance that allows adequate follow-up. 8. adequate organ function including the following:adequate hematologic function: wbc count ≥ 4,000/ul, absolute neutrophil count (anc) ≥ 1,500/ul, platelet count ≥ 100,000/ul, and hemoglobin ³ 10 gm/dl.adequate hepatic function: bilirubin ≤ 1.5 x unl, alt or ast ≤ 2.5 x unl.adequate renal function: creatinine ≤ 1.5mg/dl. 9. signed informed consent from patient or legal representative. 10. patients with reproductive potential must use an approved contraceptive method during and for 3 months after the study. females with childbearing potential must have a negative urine hcg test within 7 days prior to study enrollment. exclusion criteria: 1. concurrent administration of any other tumor therapy, including radiotherapy, chemotherapy, immunotherapy. 2. active uncontrolled infection. 3. serious concomitant disorders that would compromise the safety of patient or compromise the patient's ability to tolerate therapy. 4. second primary malignancy. 5. significant neurological or mental disorder. 6. pregnant or nursing. 7. mi within preceding 6 months or symptomatic heart disease including unstable angina, congestive heart failure, or uncontrolled arrhythmia

Keywords: non-small cell lung cancer adjuvant chemotherapy
treatment of whiplash associated disorders by apos kit

Conditions: Whiplash Associated Disorders; Cervical Pain

Summary: the purpose of this study is to compare two techniques for treating patients with whiplash associated disorders, in relation to: disability, balance, cervical pain and cervical range of motion. the hypothesis: the apos kit treatment is more effective than the short wave therapy.


Eligibility criteria:
inclusion criteria:cervical pain, motor vehicle accident a week prior to cervical pain, age above 16, ability to walk independently, signed inform consent, insured in "clalit health services" exclusion criteria: inability to walk independently, age 16 or less, not signed an inform consent, wad grade 4, past treatment for wad, pregnancy, pacemaker, cancer. -
study 08-114 open-label extension of study 08-110 - a multi-center study of denufosol tetrasodium inhalation solution in patients with cystic fibrosis lung disease (p08642)

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to obtain data on the potential of long-term treatment with denufosol to improve the clinical course of cf lung disease in patients with mildly impaired lung function and to provide cf patients who completed study 08-110 continued access to denufosol.


Eligibility criteria:
inclusion criteria: * completed study 08-110 exclusion criteria: * a female patient will not be eligible for the study if she is of childbearing potential and is pregnant, lactating, and/or not practicing an acceptable method of birth control (e.g., abstinence, hormonal or barrier methods, partner sterilization, or intrauterine device). * have a condition that might affect compliance with study procedures
concentrated cross-disciplinary group intervention for common health complaints (including post covid-19 fatigue)

Conditions: Mixed Anxiety Depression; Diabetes Mellitus, Type 2; Low Back Pain; Chronic Obstructive Pulmonary Disease; COVID-19

Summary: the health care is faced by a growing challenge in the years to come: increasing age and chronic morbidity raising the costs, combined with decreased work participation. among the conditions on the rise, we find anxiety/depression, musculoskeletal conditions, type 2 diabetes and chronic obstructive pulmonary disease. recently, the rise of the corona pandemic has yielded another group of (primarily young) patients with decreased work capacity, the post-covid syndrome sufferers. the aim of the present study is to establish, describe and summarize the experiences with a novel approach to rehabilitation for five of the most costly conditions; 1) low back pain, 2) chronic obstructive pulmonary disease, 3) type 2 diabetes mellitus, 4) mixed anxiety/depression and 5) post-covid fatigue. the concentrated interdisciplinary rehabilitation is characterised by three phases; 1. pre-intervention preparation (1-2 months): with the aim to mobilize the patients' resources for change 2. concentrated group intervention (2-5 days): interdisciplinary team - individually tailored training (further described below) 3. post-intervention follow-up (1 year): digital follow-up with the aim of integrate the changes into everyday living the concentrated intervention: the core intervention is based on trans-diagnostic features of the highly successful 4-day intervention for obsessive compulsive disorder, namely: * initiate treatment when the patient is ready for change * focus on the behavioral patterns which maintain the disorder and help the patient to identify situations where they can choose to break the pattern ("micro-choices"). * assist the patient when they practice breaking the patterns. this may pertain to how they do physical training or to the way they walk, sit, eat, talk, take their medication and sleep, or to how they engage in social activities or take care of others. * use long sessions to ensure that they face a broad range of potential micro-choices * work side-by side with others going through an analogous pattern of change * prepare them for taking responsibility for integrating the change into every-day living main outcomes will be 1. completion rates 2. patient satisfaction 3. changes to perception of illness 4. patient activation secondary outcomes will be 1. level of functioning 2. qualitative description of participants' experiences


Eligibility criteria:
inclusion criteria: * competent to consent * motivated to participate throughout the project * digital competence exclusion criteria: * medical conditions that could preclude proper participation * unable to take care of everyday needs (nursing requirements) * cognitive failure
blue light therapy for liver surgery

Conditions: Acute Kidney Injury; Liver Injury; Inflammation

Summary: the investigators hypothesize that subjects undergoing liver resection and who are exposed preoperatively to high illuminance blue spectrum light will exhibit reduced organ injury, specifically liver dysfunction, than subjects exposed to standard ambient white fluorescent light.


Eligibility criteria:
inclusion criteria: * age greater than 17 years * undergoing right or left hepatic lobectomy exclusion criteria: * presence of acute traumatic brain injury * blindness * immunosuppression or immunocompromised condition
oral progestogen supplementation in the prevention of recurrent uterine contraction in preterm labor

Conditions: Preterm Labor

Summary: the purpose of this study is to evaluate the effect of oral progesterone supplementation in preterm labor on the prevention of recurrent uterine contraction and prolonging pregnancy period, and its side effect.


Eligibility criteria:
inclusion criteria: * singleton pregnancy * preterm labor * ga24-34wk * intact membranes exclusion criteria: * maternal/fetal condition requiring immediate delivery ex. chorioamnionitis, fetal distress * placenta previa * medical and obstetric complications * allergy to dydrogesterone