Kornimate/medical-research-clean huggingface dataset:
pneumonia in the intensive care unit (icu) setting

Conditions: Pneumonia; Respiratory Failure

Summary: the purpose of this observational study is to collect prospective data on the occurrence of bacterial and viral pneumonia in the icu setting. current classification systems for pneumonia promote over treatment with antibiotics as they do not specifically recognize the presence of culture-negative and viral pneumonia. the investigators will collect data to determine if a novel pneumonia classification system can be developed that more accurately links the etiology of pneumonia (antibiotic-susceptible bacterial pneumonia, antibiotic-resistant bacterial pneumonia, culture-negative pneumonia, viral pneumonia) to clinical outcomes. additionally, the investigators will collect data on the practice of antimicrobial stewardship in the icu setting to determine if further improvements in antibiotic practices can be accomplished in the future.

the investigators will be prospectively collecting data on patients admitted to the 8300 and 8400 medical intensive care units at barnes-jewish hospital requiring invasive mechanical ventilation for support in respiratory failure from pneumonia. data will be collected on patients admitted from 1/2016-12/2016. the investigators will be collecting initial patient characteristic data as well as reviewing microbial specimen results (tracheal aspirate, bronchial alveolar lavage, viral multiplex, blood cultures) and antibiotic usage in real time. the investigators will identify any changes in antibiotic usage demonstrated with the advising of the icu antibiotic stewardship team.

Eligibility criteria:
inclusion criteria: * age 18+, admitted for 8300 or 8400 medical icu between 1/2016 and 12/2016 for respiratory failure from pneumonia, requirement of \> 24 hours of invasive mechanical ventilatory support for pneumonia exclusion criteria: * immunocompromised as defined by hiv/aids, known immunodeficiency, chronic steroids \> 20mg/day prednisone equivalent, other home immunosuppressants, solid organ or bone marrow transplant patients, cystic fibrosis, bronchiectasis, active malignancy, receiving chemotherapy or radiation therapy within the past 3 months, hematologic malignancy * chronic ventilator dependence

Keywords: invasive mechanical ventilation
effects of gaze stabilization exercises on dizziness, balance and quality of life in cervical spondylosis patients

Conditions: Dizziness; Balance; Distorted; Cervical Spondylosis

Summary: to determine the effects of gaze stabilization exercises on dizziness, balance and quality of life in patients with cervical spondylosis.

a randomized controlled trial will be performed in which total 32 patients with cervical spondylosis will be included. the data will be collected from riphah rehabilitation centre lahore and ittefaq hospital lahore. the duration of study will be ten months. dizziness handicap inventory, romberg test and vestibular disorders activities of daily living scale will be used as data collection tools. data collection will be started after taking informed consent from all patients. patients will be allocated to intervention groups by randomization. the patients in group a will be given gaze stabilization exercises and habituation exercises along with neck isometrics for 4 weeks. the patients in group b will be given neck isometrics for treatment of cervical spondylosis for 4 weeks. after data collection, analysis of pre and post values will be done by using spss 25.

Eligibility criteria:
inclusion criteria: * pre diagnosed from orthopedic doctor with cervical spondylosis * complaining of cervicogenic dizziness confirmed with positive results to the tests namely romberg's test, dizziness handicap inventory exclusion criteria: * patients with cervical radiculopathy * any drug allergy and neurological deficits were excluded from the study. * dizziness due to ear infection and due to bppv

Keywords: dizziness balance; distorted cervical spondylosis
longitudinal study of outcomes measures in als trials

Conditions: Amyotrophic Lateral Sclerosis

Summary: a new strength measurement device called accurate test of limb isometric strength (atlis) was developed to precisely and conveniently measure static limb strength in patients with als. the investigators will compare atlis data with data from two commonly used als outcomes measures, the als functional rating scale-revised (alsfrs-r) and slow vital capacity (svc) in a prospective, longitudinal study. all three outcomes measures will be performed on 100 subjects collected preferably at bi-monthly clinic visits during the study period.

four sites will participate in data collection for this study and will enroll approximately 20-30 subjects per site. subjects will be tested every 1 to 4 months for up to two years. subjects will be tested at each visit using atlis, alsfrs-r questionnaire and slow vital capacity testing. inclusion criteria: * subjects 18 years or older diagnosed with clinically possible, laboratory supported probable, probable or clinically definite als according to the world federation of neurology revised el escorial criteria. * capable of providing informed consent and complying with trial procedures. exclusion criteria: - patients, judged by the site clinical investigator to have medical conditions that may limit their ability to safely exert maximal force using the muscles in their arms and legs will be excluded from this study (e.g. unstable hypertension, significant cardiac disease, significant musculoskeletal disorders, or other medical conditions).

Eligibility criteria:
inclusion criteria: * 18 years or older * clinically possible, laboartory supported probable, probable or clinically definite als according to el escorial criteria * capable of providing informed consent exclusion criteria: * persons with medical conditions that would limit their ability to safely exert maximal force using muscles in their arms and legs (e.g. unstable cardiac, musculoskeletal, or other medical conditions)

Keywords: outcomes measures strength measurement disease progression
predicting insulin resistance in american indian youth

Conditions: Insulin Resistance; Stress, Psychological

Summary: the purpose of this study is to identify risks that may contribute to increased insulin resistance which may help explain some of the increased incidence of type 2 diabetes in american indian youth, at the rosebud reservation ages 5 to 18 years old. if specific positive indicators of insulin resistance are present, individuals are recruited back in one year for repeat of all measures.

type 2 diabetes is rapidly becoming more prevalent in the united states but especially among minority populations at a younger age. identification of risk factors, including traditional risk factors such as increased bmi, lack of exercise, increased glucose in the diet, higher blood pressure and lipids, along with other factors such as chronic stress, use of alcohol or other drugs has not previously been done with minority youth. if risk factors can be identified, more strategies for prevention of diabetes can be developed that specifically target this population. this study will enroll 300 native american youth over a 4 year period and perform body measurements including height, weight, waist circumference, blood pressure and lab values including a 2hour glucose tolerance test, fasting lipids, and a urine albumin creatinine ratio test. in addition, subjects will be asked to identify behavior and feelings of stress in everyday lives. subjects who are determined to be at increased risk of developing diabetes will be asked to repeat the tests in one year. the results will be reported to the tribal council to help determine prevention strategies.

Eligibility criteria:
inclusion criteria: * native american youth between ages of 5 and 18 who are eligible for health care at rosebud sioux reservation (rosebud, sd) and willing to be measured and participate in a 2 hour glucose tolerance test and who have parental consent. exclusion criteria: * those who have diabetes previously identified or those with chronic steroid use, or identified conditions that affect weight balance such as cancer.

Keywords: insulin resistance stress, psychological
msd belzutifan pas

Conditions: Von Hippel Lindau Disease

Summary: this is a prospective observational cohort study evaluating the effectiveness and safety of belzutifan treatment in routine clinical practice. this study has been registered and will be maintained through close out on the rwd catalogues observational registry - https://catalogues.ema.europa.eu/ under the eu pas number: eupas108114

primary objective * among new users of belzutifan with vhl disease-associated rcc, to describe the proportion of patients who undergo at least one renal tumor reductive surgery (e.g., nephrectomy) or locally directed therapy (e.g., radiofrequency ablation). * among new users of belzutifan with vhl disease-associated cns hemangioblastoma, to describe the proportion of patients who undergo at least one cns tumor reductive surgery (e.g., craniectomy) or locally directed therapy (e.g., radiation therapy). secondary objectives among all new users of belzutifan to describe: - proportion of patients with treatment emergent saes, including the nature of these events. treatment patterns including the: * duration of therapy * proportion of patients who discontinued treatment, time to treatment discontinuation, and summary of reasons for discontinuation * proportion of patients who interrupted treatment, time to treatment interruption, duration of treatment interruption, and summary of reasons for treatment interruption * proportion of patients with dose reductions, and reason for dose reduction. * among new users of belzutifan with vhl disease-associated rcc and, separately, vhl disease-associated cns hemangioblastoma, to describe: * proportion of patients who develop metastatic disease (for rcc only) * proportion of patients with occurrence of new vhl disease-associated tumor or tumor type

Eligibility criteria:
inclusion criteria: * greater than or equal to 18 years of age * diagnosed with vhl disease based on a germline test or clinical diagnosis * a decision has been made by the treating physician (at his/her discrestion) to intitate the first belzutifan treatment (i.e., belzutifan 'new users'), within the prescribing conditions of the approved product label * signed informed consent prior to or withing 30 days after the first inititaion of belzutifan exclusion criteria: * anti-cancer systemic therapy within 2 weeks prior to the index date * unable to consent to participate in the study * history of vhl disease-related metastasis or advanced cancer

Keywords: belzutifan vhl
the fibrin pad cardiovascular study

Conditions: Cardiovascular Disease

Summary: this is a three-arm, randomized multicenter study evaluating the safety and effectiveness of evarrest™ fibrin sealant patch in controlling mild to moderate vascular anastomosis suture line bleeding in cardiovascular surgery.


Eligibility criteria:
inclusion criteria: * subjects ≥18 years of age, requiring an elective or urgent, open aortic surgical procedure utilizing cardiopulmonary bypass; * subjects must be willing to participate in the study and provide written informed consent. exclusion criteria: * subjects with known intolerance to blood products or to one of the components of the study product or unwilling to receive blood products; * exposure to another investigational drug or device in a clinical trial within 30 days prior to surgery or anticipated in the 30 day follow up period after surgery. * female subjects who are pregnant or nursing.
transcutaneous pco2 assessment during intubation in icu

Conditions: Intubation in ICU

Summary: ptcco2 assessement during intubation in icu. comparison of three different preoxygenation methods.

transcutaneous pco2 assessement during intubation in icu. comparison of three different preoxygenation methods and hemodynamic changes during this period.

Eligibility criteria:
inclusion criteria: * adult patient 18 years of age or older * requiring intubation in resuscitation exclusion criteria: * contraindication to orotracheal intubation * intubation in a respiratory or cardiocirculatory arrest situation * need for intubation in great urgency preventing the installation of the transcutaneous capnia sensor and its calibration * major incapable * opposition of the patient or his relatives to the research

Keywords: transcutaneous pco2 preoxygenation post-intubation hypotension icu
creatine monohydrate as adjuvant therapy for bipolar depression

Conditions: Bipolar I Disorder; Current Episode Depressed

Summary: the purpose of this study is to determine whether creatine monohydrate is effective as an adjuvant treatment for bipolar depression.

bipolar depression is associated with high rates of disability and increased mortality. despite its major negative impact, treatment of bipolar depression is still controversial and only partially efficacious, with over half of patients not responding adequately to available treatment. in this context, the use of drugs that modulate energy metabolism has been proposed as promising new option as treatment strategies for bipolar depression. the aim of our proposed study is to perform a 6-week randomized, double-blind, placebo-controlled clinical trial of creatine monohydrate as an adjuvant treatment for bipolar depression.

Eligibility criteria:
inclusion criteria: * individuals eligible for the study will be adults aged 18 to 60 years of age who met dsm-iv criteria assessed by the scid (structural clinical interview for dsm-iv) for type i bipolar disorder, current episode depressed. * patients who have scored \> 19 on the montgomery-asberg depression rating scale (madrs) will be included, although more than two weeks of treatment with lithium (serum level\> 0.8 meq / l), valproate (serum levels\> 50 mg / l) or quetiapine (300-600mg/dia dose) or drug combination. * antipsychotics, anticonvulsants, benzodiazepines, and thyroid supplementation will be allowed if the dose has remained stable over the past two weeks. * antidepressants will be allowed if the dosage has remained stable for 4 weeks. exclusion criteria: * subjects with substance abuse within 2 weeks before inclusion or substance dependence up to 2 months will not be included. * other exclusion criteria will be: * diagnosis of schizophrenia, * dementia, * delirium, * epilepsy, * mental retardation, * clinically unstable medical illnesses, * preexisting renal disease, * history of hypersensibility to creatine. * not included are individuals at high risk for suicidal or homicidal behavior or self-mutilation will not be included. * women with gestational potential can only be included if they are using reliable contraception.
the safety and efficacy of fecal microbiota transplantation in the treatment of digestive diseases and non-digestive system diseases associated with gastrointestinal symptoms in the gastrointestinal tract.

Conditions: Fecal Microbiota Transplantation

Summary: the exploration of the safety and efficacy of fecal microbiota transplantation in the treatment of non-digestive system diseases associated with gastrointestinal symptoms in the gastrointestinal tract, while also investigating the impact of fecal microbiota transplantation on the intestinal system, and assessing the improvement of symptoms in other systems.simultaneously optimizing the conditions during the fmt process, identifying the most effective treatment methods to enhance the therapeutic outcomes of fmt.


Eligibility criteria:
inclusion criteria: * being able to tolerate a nasoenteric tube or swallow a capsule. exclusion criteria: * intestinal barrier dysfunction. inability to tolerate enteral nutrition.
observational study in type 2 diabetes treated by an intensive insulin treatment (ict) containing once daily levemir® (insulin detemir)

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this study is conducted in europe. the aim of this observational study is to gain practical experience with once-daily levemir administration in type 2 diabetes patients who were previously treated with insulatard®, humulin® n (nph insulins) as basal insulin as part of their ict under normal clinical practice conditions in hungary.


Eligibility criteria:
inclusion criteria: * type 2 diabetic subjects on intensive insulin treatment (ict) * eligibility for once daily insulin detemir administration * informed consent obtained before any observation-related activities exclusion criteria: * known or suspected allergy to insulin detemir * subjects previously enrolled in the observation * women who are pregnant, breast feeding or have the intention of becoming pregnant within 6 months.
erector spinae plane block versus thoracic epidural analgesia in patients with multiple fracture ribs

Conditions: Fracture; Rib, Multiple

Summary: to assess the analgesic and respiratory effect of continuous erector spinae plane block versus thoracic epidural in patients with multiple fracture ribs.

erector spinae plane (esp) block is a recently described technique which may be an alternative to paravertebral block (pvb) for providing thoracic analgesia. it involves injection of local anesthetic into the fascial plane deep to erector spinae muscle. esp is a more superficial block with a better defined end-point injection between the bony transverse process and erector spinae muscle. a more superficial ultrasound-guided block will be faster to perform and less painful for the patient. esp does not have the same risk of pneumothorax as pvb. epidural analgesia has become the standard of care. although thoracic epidurals provide excellent analgesia for the management of rib fractures, they are limited to a certain population due to patient factors and side-effects. many trauma patients have other injuries which contraindicate the use of epidurals, or which prevent positioning for insertion. there are disadvantages to thoracic epidural analgesia. they are technically challenging to insert, with a risk of dural puncture or spinal cord injury. adverse effects include hypotension, and if opioids used, urinary retention and pruritus. patients can develop a motor block and are unable to mobilize with an epidural in situ.

Eligibility criteria:
inclusion criteria: * patients with multiple fracture ribs. exclusion criteria: * patient refusal. * patients with pre-existing infection at the block site. * coagulopathy. * allergy to local anesthetics. * pre-existing neurological deficits. * psychiatric illness.
thiamine supplementation in heart failure: a pilot randomized controlled crossover trial

Conditions: Heart Failure; Heart Failure With Reduced Ejection Fraction; Thiamine Deficiency; Congestive Heart Failure

Summary: heart failure (hf) is a major cardiovascular disease with increasing prevalence. thiamine deficiency is common in hf patients. previous small studies have shown that thiamine supplementation can improve left ventricular systolic function in hf, but larger clinical studies are lacking. given the ease of supplementation and the potential benefits in hf, we aim to conduct a pilot randomized controlled trial (rct) using high dose thiamine supplementation in hf patients. the main goal of this pilot study is to determine the feasibility of recruitment for an rct of thiamine supplementation.


Eligibility criteria:
inclusion criteria: * age ≥60 * nyha class ii-iv symptoms * recent hf-related admission in past 12 months or nt-probnp \>600ng/l within 60 days of screening * lvef ≤45% on 2d/3d echocardiography or radionuclide angiography (rna) in the past 12 months (on optimal therapy) * medically optimized prior to enrolment with angiotensin converting enzyme inhibitor or angiotensin receptor blocker (± neprilysin inhibitor), β-blocker, and/or aldosterone antagonist at target or maximally tolerated doses. * patients must be stable on medications without hospitalization in the past month. exclusion criteria: * taking \>2.5mg/d of thiamine supplement. allows standard multivitamin. b complex vitamin not allowed due to high thiamine content. * unable to swallow study medication. a placebo swallowing test will take place at screening. * clinical indication for thiamine supplementation including symptomatic thiamine deficiency (wernicke's encephalopathy, severe malnutrition, refeeding syndrome) and heavy alcohol use, \>15 standard drinks per week in men and \>10 standard drinks per week in women. * end-stage renal disease on dialysis * severe mitral valve disease because this impacts the accuracy of speckle tracking analysis on echocardiography. * non-english speaking (unable to complete questionnaires). * unable to provide written consent. * cognitive impairment without a caregiver administering medications. * expected survival \<1 year due to non-cardiac disease. * expected heart transplantation in \<6 months (± left ventricular assistive device). * allergies to the ingredients of the study medication or placebo

Keywords: thiamine heart failure heart failure with reduced ejection fraction geriatric thiamin vitamin b1 congestive heart failure
study to evaluate the pharmacokinetics of tezepelumab in children with asthma

Conditions: Asthma

Summary: this study will evaluate the pharmacokinetic (pk) profile of a single subcutaneous (sc) dose of tezepelumab in children aged ≥ 5 to 11 years with asthma.


Eligibility criteria:
inclusion criteria: * written informed consent and written informed assent and any locally required authorisation obtained from the subject and legal representative prior to any study related procedure taking place. * age 5 to 11 years (inclusive) at visit 1 and visit 2 (day 1). type of subject and disease characteristics * documented physician diagnosed asthma for at least 6 months prior to visit 1. * documented treatment with total daily dose of either low, medium, or high dose ics for at least 6 months, as described in step 2 to step 4 of gina guidelines (gina 2020) with stable dose for at least 3 months prior to visit 1. * pre bronchodilator (bd) fev1 of ≥ 50% of predicted normal value at visit 1 * body weight ≥ 16 kg at visit 1 and visit 2 (day 1). exclusion criteria: * history of any clinically significant disease or disorder other than asthma which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study. * history of a deterioration in asthma or asthma exacerbation that required a burst of systemic corticosteroids within 6 weeks of visit 1, up to and including visit 2 (day 1). * history of hospitalisation (overnight admission) for asthma within 3 months of visit 1, up to and including visit 2 (day 1). * history of a life threatening asthma exacerbation requiring intubation or mechanical ventilation. * history of systemic corticosteroid use for the maintenance treatment of asthma within 6 weeks of visit 1, up to and including visit 2 (day 1) and discouraged until eos. * history of cancer. * history of hypersensitivity or anaphylactic reaction to any biologic therapy.

Keywords: mild asthma moderate asthma severe asthma