Kornimate/medical-research-clean huggingface dataset:
comparison of 5% nacl and 10% nahco3 as contrast agents for lung perfusion with eit

Conditions: ARDS (Acute Respiratory Distress Syndrome)

Summary: electrical impedance tomography (eit) has enabled the bedside monitoring of lung perfusion measurement through the indicator-based contrast method. currently, hypertonic sodium chloride is the most commonly used contrast agent for lung perfusion evaluation by eit. however, concerns may be raised regarding the potential risks of hyperchloremia and possible acute kidney injury associated with the use of hypertonic nacl. recently, two experimental studies found sodium bicarbonate (nahco3) might be an alternative to hypertonic sodium chloride in lung perfusion assessment by eit. however, whether nahco3 results in acceptable bias is unknown in critically ill patients. this clinical study aimed to further investigate the correlation and agreement of lung perfusion and ventilation/perfusion (v/q) match by eit contrast method between two contrast indicators (5%nahco3 vs. 10% nacl) in critically ill patients with respiratory failure.


Eligibility criteria:
inclusion criteria: * in need of lung perfusion assessment due to clinical condition * with central venous catheter exclusion criteria: * contraindications to the use of eit (automatic implantable cardioverter defibrillator, chest wounds limiting electrode belt placement, implantable pumps, etc.) * severe hyperchloremia (\>155 mmol/l) * unable to tolerate breath-hold maneuver * pregnant or breastfeeding females
acupuncture versus iv morphine in the treatment of acute pain in ed

Conditions: Renal Colic

Summary: renal colics are a common cause af acute intense pain in medical emergency settings requiring often the use of high level antalgics (opioid) to relief the patient. in the other hand, acupuncture is well known widely for its therapeutic characteristics, especially in relieving pain. the aim of these study is to compare this two pain relieving techniques in patients consulting the emergency departement (ed) for acute onset renal colics.

acute onset pain is a frequent cause for consulting the ed (2/3 of patients). renal colics are a common cause for severe acute onset pain, we think approximatively 20% of patients consulting the ed for severe (vas \> 70) acute onset pain have renal colics (rc). the guidelines for the treatment of severe rc recommend the association of two drugs: a nonsteroidal anti-inflammatory agent (nsai) typically the ketoprofen and an antalgic typically opioid (morphine). but this one face many critics regarding its safety and tolerance, that's why we investigated other pain relief strategies such as acupuncture. acupuncture is one of the five branches of the traditional chinese medicine, it has proven its efficacity and safety in many conditions and in rc. the aim of these study is to assess the feasibility, the safety, and the tolerance of an acupuncture pain-relief strategy compared to the conventional one (intravenous opioids) in the treatment of severe acute onset rc in emergency departement settings.

Eligibility criteria:
inclusion criteria: * age over 18 years * has a renal colic * vas over 70 * has not got another analgesic drug before coming to emergency departement exclusion criteria: * age under 18 years * has not renal colic * vas under 70 * has got another analgesic treatment before coming to emergency departement * fever (t° \> 38.5°c) * cutaneous infection in the punction sites * anuric patient * contre indication of morphine

Keywords: acupuncture renal colic
β-hydroxybutyrate, glucose metabolism and prediabetes

Conditions: PreDiabetes

Summary: the study aims to investigate changes in blood glucose metabolism after administration of a ketone ester drink.

new-onset prediabetes is the most significant risk factor for diabetes. clinical studies in healthy human volunteers have demonstrated that ketone esters lower blood glucose levels in both fasting and fed state. participants will visit the cosmos clinic on two occasions and will be randomly allocated to receive either the hvmn ketone drink or placebo, in a cross-over design. blood samples will be collected sequentially every 30 minutes for up to 150 minutes. blood samples will be assayed for glucose and other markers of glucose metabolism.

Eligibility criteria:
inclusion criteria: * individuals over 18 years * individuals diagnosed with prediabetes; defined based on the american diabetes association guidelines * history of at least one episode of acute pancreatitis * written informed consent exclusion criteria: * individuals who are on a ketogenic diet or consuming nutritional ketone supplements * history of cancer or chronic pancreatitis * history of bariatric or gastrointestinal surgery * pregnant or breastfeeding women * individuals involved in intensive endurance training or competitive athletics

Keywords: ketones prediabetes
qst and neuropathic pain

Conditions: Chronic Pain

Summary: to establish the sensory profile of patients using quantitative sensory testing (qst) and questionnaires as well as the level of sensitisation using temporal summation and diffuse noxious inhibitory control paradigms in all patients undergoing a chronic pain intervention at barts health nhs trust. primary objective- to identify the phenotype of responders and non-responders to a chronic pain intervention using qst sensory profile as well as the sensitisation paradigms. secondary objective- to establish the correlation between sensory profile, and sensitisation parameters as well as other measures of chronic pain as per initiative on methods, measurement and pain assessment in clinical trials (immpact) recommendation. common interventions performed at barts health nhs trust includes neuromodulation, targeted epidural steroid and/or radiofrequency treatment, 8% capsaicin patch and pharmacological interventions such as anti-neuropathic agent and opioids.


Eligibility criteria:
inclusion criteria:• male and female patients between the age of 18-80 years who have a lumbar radiculopathy who have not undergone any spinal surgery. * minimum baseline pain rating of 50mm on a 100mm nrs in the painful area * chronic pain of at least 6 months * subject satisfies standard criteria in the study centre for scs implantation and the nice 159 criteria for management of intractable neuropathic pain. * subject satisfies standard criteria in the study centre for ons implantation and the nice 452 criteria for intractable chronic migraine. * patients who have given their written informed consent. * patient is able and willing to comply with study procedures and follow up schedule. exclusion criteria:• any inclusion criteria not met * female patients of childbearing age who is or plans on becoming pregnant during the course of the study * patients who have undergone radiofrequency or injection therapy at or on a target neural structure (drg) during the past 90 days * patients with diabetes or any underlying neurological condition. * patients known to have a condition that in the investigator's judgment precludes participation in the study. * patients who have received an investigational drug or have used an investigational device in the 30 days preceding to study entry

Keywords: quantitative sensory testing
a study to evaluate aln-xdh in healthy subjects and patients with gout

Conditions: Gout

Summary: the purpose of this study is to: * part a: evaluate the safety and tolerability of single ascending doses of aln-xdh in healthy adult participants * part b: evaluate the safety, tolerability and efficacy of aln-xdh as monotherapy in adult patients with gout * part c: evaluate the safety, tolerability and efficacy of aln-xdh as add-on therapy in adult patients with gout


Eligibility criteria:
inclusion criteria: * part a: has serum uric acid (sua) level ≥4 mg/dl and ≤7 mg/dl * parts b and c: meets the american college of rheumatology criteria for acute arthritis of primary gout * part b: has an sua level ≥8 mg/dl while not receiving urate-lowering therapy (ult) or following a 1-week washout period of prior ult * part c: has been on a stable dose of allopurinol for gout for ≥6 weeks prior to screening * part c: has an sua level ≥6 mg/dl exclusion criteria: * parts a, b and c: has received an investigational agent within the last 30 days * parts a, b and c: has experienced or is being treated for acute gout flare(s) within 14 days prior to randomization

Keywords: serum uric acid sirna
low-dose total skin electron therapy in treating patients with refractory or relapsed stage ib-iiia mycosis fungoides

Conditions: Recurrent Mycosis Fungoides; Refractory Mycosis Fungoides; Stage I Mycosis Fungoides; Stage II Mycosis Fungoides; Stage III Mycosis Fungoides

Summary: this clinical trial studies low- dose total skin electron therapy in treating patients with stage ib-iiia mycosis fungoides that has not responded to previous treatment (refractory) or has returned after a period of improvement (relapsed). radiation therapy uses high energy electrons to kill tumor cells and shrink tumors. rotisserie technique is a method in which the patient receives total skin electron therapy while standing on a rotating platform. giving low dose total skin electron therapy using rotisserie technique may kill tumor cells, while having fewer side effects, and may allow therapy to be repeated in future if clinically indicated.

primary objectives: i. to assess the skin-related quality of life using an established method (skindex-29), with comparisons made between pre-treatment and each of follow-up post-treatment skin assessments. ii. to assess the durability of response using an established method (modified severity-weight assessment \[mswat\] tool), with comparisons made between pre-treatment and each of follow-up post-treatment skin assessments. iii. to determine side effect profile for low dose total skin electron therapy (tse) for mycosis fungoides administered via rotisserie technique. outline: the investigational portion of this research study involves collecting quality of life (qol) questionnaire data and objective measurements of patients' skin responses, which are obtained by the radiation oncologist during the patient's standard of care radiation treatment planning. patients will also undergo standard of care low-dose total skin electron therapy for under 1 hour daily on days 10-21. after completion of study treatment, patients are followed up at 6 and 12 weeks, and then every 3 months thereafter.

Eligibility criteria:
inclusion criteria: * biopsy confirmed mycosis fungoides stage ib-iiia * skin manifestations of mycosis fungoides that are refractory to or have relapsed on at least one prior therapy, which may include topical steroids * life expectancy \> 6 months exclusion criteria: * serious medical condition that would make treatment unsafe * pregnant or lactating patient
persistent pain after laparoscopic inguinal hernia repair

Conditions: Pain, Postoperative; Neuropathic Pain; Postherniotomy Pain

Summary: describe and characterizes laparoscopic postherniotomy patients with persistent moderate/severe pain affecting every day activities - including detailed quantitative sensory assessment


Eligibility criteria:
inclusion criteria: * male patients \> 18 yrs * no sign of hernia recurrence * chronic groin pain lasting more than 3 months * moderate/severe pain related impairment of everyday activities exclusion criteria: * other causes of persistent pain in groin region (hip, other surgical procedures) * drug or alcohol abuse * conflicting neurological disorders

Keywords: groin hernia chronic pain qst quantitative sensory testing persistent postoperative pain laparoscopic inguinal herniotomy postherniotomy pain after laparoscopic inguinal herniotomy laparoscopic inguinal hernia repair
safety and pharmacokinetic study of c13-ura in healthy volunteers

Conditions: Gastroparesis

Summary: the purpose of this study is to evaluate the safety and establish the pharmacokinetic (pk) profile of c13-ura in healthy volunteers

the c13-ura breath test kit is intended to be used as a diagnostic tool to identify rapid and/or delayed gastric emptying in patients who have upper gi symptoms such as stomach pain, fullness, early satiety, vomiting, etc., and who have suspected gastric emptying abnormalities such as gastroparesis or dumping syndrome. this study will be a double-blind, placebo-controlled, 3-period safety and pk study of 13c-uracil administered as a single oral dose of 50 mg at step 1 (period 1), 100 mg at step 2 (period 2), and 200 mg at step 3 (period 3) in the form of a semi-solid meal to subjects following at least a 10-hour fast from food and 2-hour fast from water. dosing will be followed by a 6-hour fast from food and a 4-hour fast from water. there will be a washout of at least 7 days between doses. the objectives of this study are as follows; 1)to evaluate the safety of 13c-uracil in a semi-solid meal in healthy volunteers, 2)to establish the pharmacokinetic profile of 13c-uracil in a semi-solid meal in healthy volunteers, 3)to assess the correlation between plasma concentration of 13c-uracil and urinary excretion of 13c-uracil, 4)to evaluate the reproducibility (intra/inter-individual variance) of the breath test, 5)to determine the dose for 13c-uracil that facilitates adequate δ13c in breath expired by healthy volunteers

Eligibility criteria:
inclusion criteria: * body mass index \[range is 18.5 to 29.9 kg/m2\] * in good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ecg, and vital signs exclusion criteria: * significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the investigator) * history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator * history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (except that appendectomy, hernia repair, and/or cholecystectomy will be allowed) * history or presence of an abnormal ecg, which, in the investigator's opinion, is clinically significant
assess safety & efficacy of selumetinib when given in combination with standard first line treatment for advanced non-small cell lung cancer

Conditions: Locally Advanced or Metastatic NSCL Cancer Stage IIIB IV

Summary: this is a phase i, open label multicentre study of selumetinib administered orally in combination with first line chemotherapy regimens to patients with advanced/metastatic nsclc. the study has been designed to allow an investigation of the optimal dose of selumetinib in combination with various standard first line double-platinum chemotherapy regimens. initial assessment will be based on tolerability of selumetinib in combination with one or more selected regimens that are considered to be tolerated also being assessed for preliminary evidence of activity. this study is a dose finding and optional cohort expansion; in addition all patients will be assessed for anti-cancer efficacy of the combination of selumetinib and chemotherapy.

a phase i, open label, multicentre study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of selumetinib (azd6244; arry-142886) in combination with first line chemotherapy regimens in patients with non-small cell lung cancer (nsclc)

Eligibility criteria:
inclusion criteria: * provision of signed, written and dated consent prior to any study specific procedures * male or female, aged 18 years or older * histological or cytological confirmation of locally advanced or metastatic nsclc (iiib-iv) * female patients must not be breast-feeding and have a negative pregnancy test prior to start of dosing or must have evidence of non-child-bearing potential * patients must be eligible to receive treatment with the platinum doublet combination with which selumetinib is being combined and in accordance with the local product information exclusion criteria: * prior chemotherapy or other systemic anti-cancer treatment for advanced nsclc. * prior surgery or radiotherapy within 6 months or palliative radiotherapy within 4 weeks of start of study treatment. * female patients who are breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control * another primary malignancy within 5 years of starting study treatment, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ. * as judged by the investigator, any evidence of severe or uncontrolled systemic diseases, active bleeding diatheses, renal transplant, or active infection

Keywords: mek1/2 inhibitor, non small cell lung cancer, metastatic, first line treatment for non small cell lung cancer
efficacy of adhesive strength of new hydrogel formulation

Conditions: Stroke, Acute

Summary: the study will look at the stickiness of a new skin adhesive incorporated into a new next generation geko™ device called the geko™ x-t3 and compare it to the adhesive currently used into the geko™ t3 device. the study is for people who are in hospital in the acute stroke unit, and who will be receiving daily treatment with the geko™ t3 device in line with uk guidelines as part of their standard acute stroke care and venous thromboembolism prevention.

the new skin adhesive incorporated into the next generation geko™ device designated geko™ xt-3 has previously been tested to current international biocompatibility standards (iso10993) , however the skin adhesive strength of the geko™ x-t3 device compared to that of the current geko™ t3 device has not yet been tested. the reason behind the study is to compare the skin adhesive strength of the two devices in a similar use environment, to determine whether the geko™ xt-3 device will be a suitable replacement for the geko™ t3 device. in total 40 people who are patients in hospital in the acute stroke unit, and who will receive daily treatment with the geko™ t3 device as part of their acute stroke care and venous thromboembolism prevention pathway will be asked if they would like to take part in the study. 20 patients will receive their normal daily treatment with the currently in use geko™ t3 device and 20 patients will receive their normal daily treatment with the new geko™ xt-3 device which has the new skin adhesive. phase 1 will take place before phase 2 and each phase will last for a maximum of 10 days or until patients are able to walk independently. each day during the study and after their standard treatment has been completed, a member of the healthcare team will ask the patient questions about their experience with geko™ device and the answers recorded. the standard acute stroke care patients receive when on the study will not be affected, regardless of which geko™ device they receive and because the study fits into the normal treatment given to these stroke patients whilst in hospital there will be no additional study visits.

Eligibility criteria:
inclusion criteria: * male or female aged ≥ 18 years * currently an in-patient hospitalised for acute stroke * use of geko™ as a mechanical prophylaxis strategy for venous thromboembolism * patient understands and is willing to participate in the study and is able to comply with study procedures exclusion criteria: * pregnancy or breast feeding * use of any neuro-modulation device other than geko™ * participation in any other clinical study that may interfere with the outcome of either study
comparison of embedded and added motor imagery training in patients after stroke

Conditions: Stroke

Summary: the purpose of the study is to examine if patients in the embedded motor imagery (mi) training group (eg1) need less time to perform the motor task than patients in the added mi training group (eg2).

the purpose of the study is to examine if patients in the embedded mi training into physiotherapy (eg1) need less time to perform the motor task than patients in the added mi training to physiotherapy (eg2). a third groups serves a control group (cg) to investigate the effect of the intervention versus a group with a control intervention. additionally, semi-structured interviews before and after the intervention will give an insight in the patient's experience with motor imagery (mi), their expectations regarding the intervention and their opinions about mi after the intervention.

Eligibility criteria:
inclusion criteria: * patients after a first-ever ischemic or hemorrhagic stroke * outpatients or leaving inpatients 3 months after stroke * ability to stand with or without a cane for at least 30 sec on a normal hard floor * ability to walk for 20 metres with or without a cane or an orthosis * mmse with at least 20 points * age older than 18 years * signed written informed consent exclusion criteria: * joint replacements (knee, hip, shoulder) * limiting pain in the upper or lower body * limiting range of motion (rom) in the hip, knee, ankle joint or toes * body weight more than 90 kilograms * compromised mental capacity to give written informed consent

Keywords: motor imagery motor skill performance improvement
prophylactic environmental management of delirium

Conditions: Delirium; Falls

Summary: delirium is a complex neuropsychiatric syndrome with an acute onset and fluctuating course which is presented in 15 to 20% of patients admitted to general wards. it is a potentially life - threatening complication which can be prevented. it is the objective of this randomized controlled trial to evaluate whether a multicomponent environmental intervention could reduce the incidence of delirium in a general medical ward.

a total of 287 patients 65 years of age or older who had been admitted to a general medicine ward and who were at risk of delirium were studied. eligible patients were randomized to a multicomponent environmental intervention or standard care. both groups were well balanced in patients characteristics and followed during the full hospital stay by a group trained in the application of the confusion assessment method to detect incident delirium.

Eligibility criteria:
inclusion criteria: * above 65 years of age and one of the following: * age above 70 years. * alcoholism * cognitive deficit (mini mental state examination \<24 points) * metabolic disturbance (hyponatremia, hypernatremia, hyperkalemia, hypokalemia hyperglycemia or hypoglycemia) exclusion criteria: * delirium at admission. * admittance to a ward other than general internal medicine. * lack of family support. * informed consent refusal. * hospitalization in a room with more than two beds.

Keywords: delirium primary prevention elderly