Kornimate/medical-research-clean huggingface dataset:
observational cohort study of a national extracorporeal membrane oxygenation service for adults with respiratory failure: the nhs ecmo study.

Conditions: Acute Respiratory Failure

Summary: this is an observational study of outcomes of the nhs england-commissioned national respiratory ecmo service, which has been active at six centres since december 2011. the primary outcome of interest is the number of patients who survive to icu discharge at the ecmo centre. the study also aims to identify factors predictive of outcome.

recent randomised and observational studies suggest there may be a role for extracorporeal membrane oxygenation (ecmo) in patients with severe acute respiratory failure that have not responded to conventional measures. in 2011, nhs england commissioned a national service to provide ecmo for severe respiratory failure at six centres across the country. patients with severe respiratory failure are referred to the network if conventional measures are unsuccessful, and if accepted are transferred to an ecmo centre for specialist care. the criteria for admission is at the discretion of clinicians at each centre. the nhs ecmo registry has been created by cross-referencing data submitted to the extracorporeal life support organisation (elso) in ann arbor, michigan, with a tracker document identifying patients treated within the network. analysis has been undertaken from december 2018 to march 2019.

Eligibility criteria:
inclusion criteria: * ultimately at the discretion of the clinician at the relevant ecmo centre * aged ≥16 years * severe acute respiratory failure refractory to conventional management * no contra-indication to ongoing ecmo therapy exclusion criteria: * any contra-indication to ongoing ecmo therapy * need for ecmo due to other aetiology than acute respiratory failure (e.g. bridge to transplantation, extracorporeal cpr, isolated acute cardiac failure)

Keywords: ecmo ards acute respiratory failure
a 4 week study with bi 144807 in patients >= 50 years with wet age related macular degeneration

Conditions: Wet Macular Degeneration

Summary: the present trial will use an open label design to investigate the effect of bi 144807 on central 1-mm retinal thickness and presence of neovascular leakage in newly diagnosed wamd patients. a further objective is to collect data on adverse events, vital signs, ecg and clinical laboratory parameters of bi 144807 in the same patient group.


Eligibility criteria:
inclusion criteria: newly diagnosed men and women with unilateral subfoveal choroideal neovascularization secondary to age-related macular degeneration exclusion criteria: additional eye disease that could compromizse best corrected visual acuity, such as uncontrolled glaucoma
mindfulness-based ecological momentary intervention for opioid use disorder and chronic pain

Conditions: Chronic Pain; Opioid Use Disorder

Summary: the goal of this clinical trial is to evaluate whether a smartphone app-based ecological momentary intervention called mindful journey, which teaches mindfulness skills, can support adults in recovery from both opioid use disorder and chronic pain. the primary objective of this pilot study is to assess the feasibility and acceptability of mindful journey in this population.

there is a paucity of interventions for co-occurring opioid use disorder and chronic pain. difficulty with emotion regulation is a key shared vulnerability factor underlying both conditions. mindfulness-based interventions (mbis) are a promising intervention approach, as they target core skills that can improve emotion regulation. however, research on mbis for co-morbid opioid use disorder and chronic pain is limited. existing mbis are also limited by not providing adequate support "in the moment" when individuals are in high-risk situations. a responsive, momentary mbi for co-occurring opioid use disorder and chronic pain may be highly promising, but has yet to be established. in the present study, we will be evaluating a smartphone app-based ecological momentary intervention, called mindful journey, for individuals with opioid use disorder and chronic pain. the core feature of the app is training in mindful acceptance and savoring skills via momentary "just-in-time" delivery of brief video-based exercises when individuals report elevations in challenging emotional states (e.g., craving, stress, and pain) and/or decreases in positive affect based upon ecological momentary assessments.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * fluent in english * enrollment in medication-assisted treatment for opioid use disorder * report at least bothersome chronic pain, as indicated by graded chronic pain scale-revised * has a smartphone. exclusion criteria: * self-reporting of chronic malignant pain (e.g., cancer) or systemic inflammatory disease (e.g., rheumatoid arthritis, ankylosing spondylitis, lupus, and sarcoidosis) * self-reporting of psychotic disorder symptoms * participated in the previous phase of the study in which participants provided feedback to inform the development of the mindful journey app.

Keywords: mindfulness opioid use disorder chronic pain mhealth ecological momentary intervention
a study of dulaglutide (ly2189265) 3.0 mg and 4.5 mg in pediatric participants with type 2 diabetes mellitus (award-peds plus)

Conditions: Type 2 Diabetes

Summary: the main purpose of this study is to evaluate additional dosing options for dulaglutide in pediatric participants with type 2 diabetes. participation in this study will last about 8 months.


Eligibility criteria:
inclusion criteria: * have type 2 diabetes treated with diet and exercise and metformin and/or basal insulin. metformin and/or basal insulin dose must be stable for at least 8 weeks prior to screening. * have a body weight ≥50 kilograms (kg) and body mass index (bmi) of \>85th percentile exclusion criteria: * have type 1 diabetes * have received treatment with any glucose-lowering agent(s) other than metformin or basal insulin within 8 weeks prior to screening * after the type 2 diabetes diagnosis, have a history of diabetic ketoacidosis or hyperosmolar syndrome * have had ≥1 episode of severe hypoglycemia and/or ≥1 episode of hypoglycemic unawareness within the last 6 months * have family or personal history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia syndrome type 2 (men2) * have prior chronic, recurrent, or idiopathic pancreatitis, or known gallbladder disease * have been treated with prescription drugs or over-the-counter medications that promote weight loss within 8 weeks prior to screening
the montreal cognitive assessment as a screening tool for preoperative mild cognitive impairment in geriatric patients

Conditions: Mild Cognitive Impairment

Summary: this is a prospective, double-blinded, control trial. the montreal cognitive assessment is used to screen preoperative mild cognitive impairment in 582 consecutive geriatric patients, scheduled for general, vascular or urological surgery under general and/or regional anesthesia.

at the preoperative visit, the co-researcher invites 322 general and vascular patients (male 190, female 132) and 260 urological patients (male 220, female 40) who meet the inclusion criteria to join the study. the process of the project is explained to the interested patients in details before an informed consent is obtained. all participants are interviewed by using the montreal cognitive assessment test. the history of drug used preoperatively (medication reconciliation) has also been recorded.

Eligibility criteria:
inclusion criteria: * male or female aged 65 yr, asa i-iii scheduled for elective general, vascular or urological surgery under general and/or regional anesthesia. exclusion criteria: * unable to communicate in reading and writing * psychosomatic patients * insulin-dependant diabetes * renal insufficiency (creatinine \>1.5 mg/dl), renal dialysis * uncontrolled congestive heart failure (american heart association classification iii or iv congestive heart failure), unstable angina, untreated cardiac arrhythmia * active gastrointestinal bleeding.

Keywords: mild cognitive impairment montreal cognitive assessment test
the role of textrad on detection of liver metastasis in rectal cancer

Conditions: Rectal Cancer

Summary: this is a retrospective analysis of all patients diagnosed with larc who received ncrt and had mri scans between 2003-2014 at east suffolk and north essex nhs foundation trust. region of interest was drawn around the tumor or its location on t2 mri images. six texture parameters were systematically extracted from textural histograms of post-treatment scans. these parameters were examined to determine their ability to predict local recurrence and distant metastases through kaplan-meier survival curves and log-rank tests.


Eligibility criteria:
inclusion criteria: * all subjects must have mri post-chemotherapy treatment to detect the response to neoadjuvant treatment and compare it to pre-treatment scans to easily determine if there were a posttreatment liver metastasis. * locally advanced rectal cancer (larc) = mri stage: t3/t4 and/or n1/n0. exclusion criteria: * distant metastases. * synchronous tumour.
granisetron 1 mg tablets, non-fasting

Conditions: Healthy

Summary: the objective of this study is to evaluate the comparative bioavailability between granisetron hydrochloride 1 mg tablets (teva pharmaceuticals usa) and kytril® 1 mg tablets (roche, usa), after a single-dose in health subjects under fed conditions.

criteria for evaluation: fda bioequivalence criteria statistical methods: fda bioequivalence statistical methods

Eligibility criteria:
inclusion criteria: * healthy, non-smoking, male and female subjects, 18 years of age or older. * bmi ≥ 19 and ≤ 30. * no significant diseases or clinically significant findings in a physical - examination. * no clinically significant abnormal laboratory values. * no clinically significant findings in the 12-lead electrocardiogram (ecg). * no clinically significant findings from the vital signs measurement. * be informed of the nature of the study and given written consent prior to receiving any study procedure. negative for: * hiv. * hepatitis b surface antigen and hepatitis c antibody. * urine drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines and methadone). * urine cotinine test. * serum hcg consistent with pregnancy (females only). females who participate in this study are: * unable to have children (e.g. post-menopausal, tubal ligation, hysterectomy) or * willing to remain abstinent \[not engage in sexual intercourse\] or * willing to use an effective method of double-barrier birth control \[partner using condom and female using diaphragm, contraceptive sponge, spermicide or iud\] * females who participate in this study are not pregnant and/or non-lactating. exclusion criteria: * known history or presence of any clinically significant medical condition. * known or suspected carcinoma. * on a special diet within 4 weeks prior to drug administration (e.g. liquid, protein, raw food diet). * participated in another clinical trial or received an investigational product within 30 days prior to drug administration. * donated up to 250 ml of blood within the previous 30 days or donated from 251 to 500 ml of blood in the previous 45 days or donated more than 500 ml of blood in the previous 56 days (based on the canadian blood services guideline for blood donation). * females taking oral or transdermal hormonal contraceptives within 14 days preceding period 1 dosing or females having taken implanted or injected hormonal contraceptives within 6 months prior to period 1 dosing. * requirement of any non-topical medication (prescription and/or over-the-counter) on a routine basis. * difficulty fasting or consuming the standard meals. * do not tolerate venipuncture. * unable to read or sign the icf. known history or presence of: * hypersensitivity or idiosyncratic reaction to granisetron hydrochloride and/or any other drug substances with similar activity. * alcoholism within the last 12 months. * drug dependence and/or substance abuse. * use of tobacco or nicotine-containing products, within the last 6 months.

Keywords: bioequivalence healthy subjects
targeting cervical epidural spinal cord stimulation for functional recovery

Conditions: Cervical Spinal Cord Injury; Tetraplegia/Tetraparesis; Cervical Myelopathy

Summary: the proposed study seeks to understand how the cervical spinal cord should be stimulated after injury through short-term physiology experiments that will inform a preclinical efficacy trial. the purpose of this study is to determine which cervical levels epidural electrical stimulation (ees) should target to recruit arm and hand muscles effectively and selectively in spinal cord injury (sci).

for people with cervical spinal cord injury (sci), regaining hand and arm function is their highest priority. epidural stimulation enables recovery of walking and autonomic function in people with chronic sci, but how the spinal cord should be stimulated to restore arm and hand function is not known. this project seeks to advance our understanding of how best to apply epidural electrical stimulation (ees) after cervical sci using complementary experiments in humans and rats. this improved understanding will be used to conduct a preclinical study of the efficacy of different sites of cervical spinal cord stimulation.

Eligibility criteria:
inclusion criteria: •clinical indication for cervical spine surgery. exclusion criteria: •stimulation devices in the neck or chest (e.g., vagal nerve stimulation, cardiac patients with pacemakers)

Keywords: spinal cord injury upper-limb muscle activation cervical spinal cord myelopathy
the listening project at reiss-davis/vista del mar child and family services

Conditions: Auditory Perceptual Disorders; Stress Disorder

Summary: a research project funded by the reiss-davis child study center of vista del mar (rdcsc/vdm) will be conducted on the vista del mar campus of the rdcsc/vdm to evaluate the effectiveness of the listening project protocol (lpp) in children who have difficulties with autonomic and behavior regulation in the classroom. the lpp is designed as a "neural exercise" to reduce auditory hypersensitivities, to improve auditory processing of speech, and to improve behavioral state regulation. the lpp uses acoustic stimulation to exercise the neural regulation of the middle ear structures to rehabilitate and to normalize the acoustic transfer function of the middle ear structures. the current study is being conducted to evaluate efficacy and feasibility of the lpp with emotionally disturbed and learning challenged young people and will use objective measures to evaluate changes in acoustic transfer function of the middle ears structures, auditory processing skills, physiological state regulation, sensory symptoms, and academic pre and post testing.


Eligibility criteria:
inclusion criteria: * children must be between ages 6-17 years * children must be able to read/speak in english. parents must be able to read/speak in either english or spanish * children must be patients, students and/or residents at reiss-davis/vista del mar exclusion criteria: * children who wear a hearing device * children with a history of heart disease * children who are currently being treated for a seizure disorder * children who are non-verbal

Keywords: autonomic nervous system auditory processing disorder social behavior
a pilot study investigating the effects of acetyl-l-carnitine and vincristine-induced neuropathy in pediatric patients with all

Conditions: Vincristine Induced Neuropathy

Summary: the purpose of this study is to see if a drug called acetyl-l-carnitine can help prevent painful nerve damage and nerve pain which is caused by vincristine, a drug used in chemotherapy in children being treated for newly diagnosed all. acetyl-l-carnitine is a drug available for purchase as a nutritional supplement but for the purpose of this study is experimental.


Eligibility criteria:
inclusion criteria: * subjects must meet the following inclusion criteria. * the subject must have a confirmed diagnosis of acute lymphoblastic leukemia within 1 week of starting therapy * currently being treated on a standard all induction regimen * subjects must be greater than or equal to 5 and less than 18 years old * signed informed consent exclusion criteria: * subjects will be excluded for the following: * preexisting neurologic disease, including grade ii, iii, or iv neurological status by nci common toxicity criteria v3.0 on clinical exam * history of hypersensitivity to vincristine * history of hypersensitivity to acetyl-l-carnitine * previous use of acetyl-l-carnitine * concurrent anti-convulsant use * concurrent gabapentin use * concurrent glutamine use * liver function: total bilirubin greater than 1.3 mg/dl and serum glutamic-pyruvic transaminase (sgpt) (alt) greater than 5 x upper limit of normal for age and serum albumin less than 2 g/dl * patients who are pregnant
bronchodilator properties and safety in asthma

Conditions: Asthma

Summary: recent large clinical studies have demonstrated the interest of lama therapy in the management of asthma, when compared to laba. v0162 is a compound with a very long lasting bronchodilator effect when compared to reference treatment in non-clinical models and in copd patients. secondary properties of v0162 (i.e.h1/h4 and pde iv-inhibition) could enhance the efficacy of this antimuscarinic compound and could bring option in the treatment obstructive lung disease. the objective of the study is to assess the bronchodilator properties of v0162 during 8 days in adult patients with asthma usually treated with ics and laba. the study is a randomised, double-blind, placebo-controlled, 3-period crossover, preceded by an open-label active-control period before randomisation.


Eligibility criteria:
inclusion criteria: * aged 18 to 65 years-old. * 18 ≤ bmi \<30 kg/m². * clinical history consistent asthma, in the judgement of the investigator. * asthma controlled or partly controlled according to gina 2012 criteria: * asthma treated by ics and laba (fixed-dose combination or free combination) at stable dose for at least 3 months. * able to replace the usual ics and laba therapy by ics at the usual dose regimen and salbutamol as needed. * able to stop salbutamol at least 6 hours before a study visit. * able to perform at least 3 acceptable and reproducible fev1 and fvc measurements according to ers/ats 2005 recommendations. exclusion criteria: * clinically significant respiratory conditions other than asthma (e.g. pneumonia, pneumothorax, atelectasis, bronchiectasis, chronic bronchitis, copd, emphysema, pulmonary arterial hypertension, pulmonary fibrosis,etc.). * upper or lower respiratory tract infection within 4 weeks. * exacerbation (requiring oral corticosteroids or hospitalization) within 3 months. * current smoker or former smoker less than 6 months or total lifetime smoking history greater than 10 pack-years. * intolerance to salbutamol. * intolerance to tiotropium (or any other atropine-derived compound). * intolerance to one of the ingredients of the study product * severe hepatic impairment, moderate to severe renal impairment, epilepsy, narrow angle glaucoma, gastrointestinal obstruction, moderate to severe prostatic hypertrophy, bladder neck obstruction. * any acute or chronic disease that will not allow the participation in the study, in the judgement of the investigator. * clinically relevant physical examination abnormality.

Keywords: asthma, copd, broncodilator, airway, lung, inhalation, antimuscarinic
green tea extracts for mild-to-moderate diabetic peripheral neuropathy

Conditions: Diabetic Peripheral Neuropathy

Summary: the present randomized placebo-controlled study aimed to evaluate the effect of green tea extract administration on the clinical and neurophysiological parameters in patients with mild-to-moderate diabetic peripheral neuropathy.


Eligibility criteria:
inclusion criteria: * diabetic patients with peripheral neuropathy exclusion criteria: * patients under treatment of diabetic peripheral neuropathy. * patients with other causes of peripheral neuropathy.
cooling vest in men with hot flashes

Conditions: Hot Flashes

Summary: this study is intended to determine the efficacy of the cooling vest in reducing the frequency and intensity of hot flashes and night sweats in men undergoing chemotherapy treatment for prostate cancer.

the cooling vest is a vest manufactured by nanohealth, inc. it is a cool therapy device intended to provide moderate, controlled cooling (approximately 15c/59f) by absorbing heat. the material in the vest is safe, non-toxic, and eco-friendly. this study attempts to collect data on the effects of the cooling vest in men with hot flashes and night sweats due to the side effects of chemotherapy. participants will use the vest for 4 weeks and questionnaires will be used to determine effect.

Eligibility criteria:
inclusion criteria: * males, who are at least 18 years old. * self-reports having at least two (2) daily hot flashes associated with prostate cancer chemotherapy-induced hot flashes and night sweats. exclusion criteria: * has another existing medical condition that would prevent study compliance.
group versus individual acupuncture for cancer pain

Conditions: Cancer; Pain

Summary: typically, in north america, acupuncture is performed on an individual basis. however, community acupuncture, also known as group acupuncture, is an emerging method of treating patients. cancer patients, post-treatments were given acupuncture treatments to help alleviate pain, in a two-arm randomized trial.

typically, in north america, acupuncture is performed on an individual basis. however, community acupuncture, also known as group acupuncture, is an emerging method of treating patients. although the practice can vary, community acupuncture is performed in a group setting, typically with reclining chairs dispersed around a large room, and one practitioner treating up to six people per session. the outcomes of this this randomized controlled trial will allow the researchers to assess whether group acupuncture is a viable treatment option for people with cancer who are suffering from pain, especially those who are either resistant to or looking to avoid the side effects of opioids. objectives examine the efficacy of community acupuncture for alleviating cancer pain, fatigue, sleep disturbances and distress when compared to individual acupuncture. evaluate the cost-effectiveness of community acupuncture compared to individual acupuncture.

Eligibility criteria:
inclusion criteria: 1. adult cancer patients (≥18 years old), both male and female. 2. experiencing pain with a minimum worst pain score (in the previous week) ≥3 on the 10-point brief pain inventory (bpi). 3. all tumor groups, including metastatic patients. 4. participant's pain can originate from any source, including postoperative, malignancy related, and neuropathic pain. 5. must be willing to be randomized into either group, and must be able to attend a minimum of nine treatment sessions within a six-week period. exclusion criteria: 1. use of acupuncture within the previous six months. 2. currently on or within one-month of active treatment (chemotherapy or radiation).

Keywords: acupuncture group community based individual randomized