Kornimate/medical-research-clean huggingface dataset:
biomarkers in cerebrospinal fluid in critical care patients with delirium

Conditions: Delirium; Cognitive Dysfunction

Summary: critical care patients are at a high risk of developing delirium and impaired cognitive function 3 and 12 months after their icu stay. in this study the aim is to try to elucidate the pathophysiology behind delirium in the icu and subsequent development of cognitive dysfunction in icu survivors. biomarkers in cerebrospinal fluid (csf) will be analysed in patients with and without delirium in the icu. samples will also be taken 3 and 12 months after the icu-stay. csf will also be obtained in healthy age- and sexmatched controls undergoing surgery.

critical care patients are at a high risk of developing delirium, a form of acute brain dysfunction, and may develop impaired cognitive function 3 and 12 months following their icu stay. in this study the aim is to try to elucidate the pathophysiology behind delirium in the icu comparing patients with and without delirium and possible development of cognitive dysfunction in icu survivors. neuroinflammatory markers and markers of structural damage in cerebrospinal fluid (csf) will be analysed in patients with and without delirium assessed with the cam-icu (confusion assessment method) test in the icu. csf samples will also be taken in icu-survivors, 3 and 12 months after the icu-stay. for comparison csf will be obtained in healthy age- and sexmatched controls undergoing surgery in spinal anesthesia.

Eligibility criteria:
inclusion criteria: * patients admitted to icu for acute respiratory, septic and/or circulatory chock exclusion criteria: * abnormal coagulation * recent exposure to intensive care * patients unable to assess for delirium * patients difficult to follow up * patients expected to live less than 24 hrs * patients with known cognitive dysfunction based on medical records or relatives report * abnormal coagulation
metabolic effects of high-amylose wheat-based breads

Conditions: Postprandial Hyperglycemia

Summary: the amylose-amylopectin ratio influences starch properties. a higher amylose content is associated with slower starch digestion thus reducing the postprandial plasma glucose response and improving the overall postprandial metabolism. so far, limited evidence is available on the metabolic effect of wheat-based foods rich in amylose. this randomised controlled study investigated the acute metabolic effects of amylose-rich wheat-based breads in overweight subjects focusing on potential mechanisms.


Eligibility criteria:
inclusion criteria: * overweight/obese * 18-70 years exclusion criteria: * age \ 70 years; * fasting triglycerides ≥400 mg/dl; * fasting cholesterol \>270 mg/dl; * cardiovascular events (myocardial infarction or stroke) during the 6 months prior to the study * established diabetes mellitus or any chronic disease * renal and liver failure (creatinine \>1.7 mg/dl and transaminases \>2 times than normal values, respectively) * anaemia (hb \<12 g /dl)
routine pregnancy screening for women on opioid substitution therapy

Conditions: Substance Use Disorders; Prenatal Care; Pregnancy Outcome

Summary: women who take opioid substitution therapy have higher rates of unintended pregnancy, more pregnancies, and a higher risk of pregnancy complications than the general population. current practice is to test for pregnancy only at patient request or if the clinician suspects pregnancy. this study will compare monthly pregnancy testing to current practice in a double blind randomized control trial. as many women of childbearing age as possible will be recruited from the hamilton clinic for opioid substitutional therapy. women assigned to the intervention will have monthly testing at the same time as their monthly urine drug testing at the clinic. the primary objective is to assess if there is a significant difference is early pregnancy detection and the secondary objectives are to assess differences in pregnancy disposition and gestational age at entry to prenatal or abortion care.

the routine pregnancy screening in women on opioid substitutional therapy study involves screening women from the the hamilton clinic for ost regularly for pregnancy to determine if this results in earlier prenatal care and improved pregnancy disposition. all eligible women at the hamilton clinic will be approached for recruitment. the study phase last for 18 months. the investigators will assess for any significant difference in the rates of early pregnancy diagnosis, pregnancy disposition, and associated outcome measurements. study results could inform best practices in the care of child-bearing women on ost and will provide baseline information and feasibility data to inform design of a larger rct to assess the effect on pregnancy and birth outcomes. this pilot study will serve to demonstrate whether routine pregnancy screening is effective for earlier pregnancy diagnosis and whether it has any impact on pregnancy disposition and entry into pregnancy-related care for women on ost. in addition, the investigators will also be seeking to address whether routine pregnancy testing is logistically and financially feasible for patients receiving ost at a primary care-run addiction setting. if this intervention is found to be both effective and feasible, it would be possible to apply this study methodology to larger-scale rcts across multiple clinical sites with the power to assess maternal and fetal outcomes.

Eligibility criteria:
inclusion criteria: * currently on methadone or buprenorphine maintenance therapy * have some male sexual partners exclusion criteria: * females who have exclusively female sexual partners * a previous diagnosis of premature menopause * hysterectomy, oophorectomy, and/or tubal ligation * current pregnancy * current intrauterine device (hormonal or non-hormonal) * unable to give informed consent in english

Keywords: opioid substitution therapy pregnancy tests
the impact of inorganic nitrate-rich beetroot juice on microvascular blood flow and cognitive function

Conditions: Post Menopausal

Summary: cardiovascular disease (cvd) is one of the leading causes of mortality worldwide. inorganic nitrate found in beetroot and green leafy vegetables has been demonstrated to reduce cardiovascular disease risk factors including reducing blood pressure and the stiffness of blood vessels by increasing levels of a compound called nitric oxide. much of the research to date has focused on the large blood vessels, and little is known about the impact of inorganic nitrate on smaller blood vessels which could be related to cognitive function. the majority of beneficial effects with inorganic nitrate have been observed within young healthy populations. however, it is known that after the menopause women are at an increased risk of cardiovascular disease and have reduced levels of nitric oxide in their body; this could also contribute to the cognitive decline also observed post-menopause. this trial will investigate the impact of inorganic nitrate from beetroot juice on the blood flow in small blood vessels and on cognitive function in postmenopausal women. the hypothesis of the study is that the nitrate in beetroot juice will increase circulating nitric oxide that will then increase blood flow in small blood vessels and improve cognitive function.


Eligibility criteria:
inclusion criteria: * apparently healthy post-menopausal women (age over 45) * able to understand information sheet and willing to comply with the study protocol and able to give informed consent * not having menstrual period for 12 months exclusion criteria: * blood pressure \ 140/90 mmhg * medical history of myocardial infarction, angina, thrombosis, stroke, cancer, high cholesterol, liver, renal, respiratory or bowel diseases or diabetes or other endocrine disorder * bmi\>30 * any tobacco and/or nicotine users (or quit within the last 6 months) * current use of antihypertensive medication * alcohol intake \> 14 units/week * vigorous exercise \> 3 times/ week * antihypertensive medication users * people who have had hysterectomy * currently taking hormone replacement therapy or selective oestrogen receptor modulator

Keywords: beetroot no nitrate microvascular function cognition
expanded access to mepsevii

Conditions: MPS VII; Mucopolysaccharidosis VII; Sly Syndrome

Summary: individual patient expanded access requests may be considered for patients who have no other treatment options

expanded access may be available outside of the us in countries prior to approval by the local regulatory agencies. for full details, please visit the links provided below.

Eligibility criteria:
inclusion criteria: - exclusion criteria: -

Keywords: expanded access compassionate use
point-of-care tbi detection system for head injured patients in the emergency department

Conditions: Brain Injuries

Summary: a prospective, non-randomized trial for the extension and replication of the development database of brain electrical activity recordings and clinical information collected from patients who present to the ed following closed head injury.

the objective of this study is to test the clinical utility of the brainscope technology for the acute identification of traumatic structural brain injury in the tbi population, following closed head injury. the data generated will serve to validate and/or refine the current algorithms to detect acute, traumatic, structural brain injury.

Eligibility criteria:
inclusion criteria: * subjects who are admitted to the ed and are suspected of a traumatic, closed head injury within 24 hours. the patient will have a gcs 12-15 upon arrival to the ed even if gcs was lower prior to arrival to the ed (e.g., at the time of injury). exclusion criteria: * subjects will be excluded who have forehead, scalp, or skull abnormalities or other conditions that would prevent correct application of the electrode headset on the skin. * in addition, * subjects with dementia, * parkinson's disease, * multiple sclerosis, * seizure disorder, * brain tumors, * history of brain surgery, * psychiatric disorder being managed by a psychiatric healthcare professional/provider, * substance dependence, * history of tia or stroke within the last year, * currently receiving dialysis or in end-stage renal disease, * active fever defined as greater than 100 degrees f or 37.7 degrees c, * current condition is "critical" in the opinion of the investigator, * subject is suffering from an open head injury, * subject requires advanced airway management (i.e. mechanical ventilation), currently receiving procedural sedation medications. * subjects below the age of 18 years, and prisoners will not be eligible for study.
trial of vitamin d supplementation for the prevention of influenza and other respiratory infections (vidiflu)

Conditions: Respiratory Tract Infections; Influenza

Summary: purpose: the study null hypothesis is that vitamin d supplementation will not influence time to acute respiratory tract infection in sheltered accommodation residents.

the study population will comprise sheltered accommodation residents and staff fulfilling eligibility criteria. half of the sheltered accommodation schemes will be randomly allocated to 2-monthly oral bolus vitamin d supplementation (vigantol oil) over a period of one year, and half to placebo. participants will be followed for one year.

Eligibility criteria:
inclusion criteria: * permanent resident or member of staff at sheltered accommodation unit * if a woman of child-bearing potential, is sexually abstinent or has negative pregnancy test within 7 days of recruitment and agrees to use reliable form of contraception until she has completed the study * able to give written informed consent to participate * age ≥ 16 years on day of first dose of imp exclusion criteria: * current diagnosis of asthma or chronic obstructive pulmonary disease * chronic upper or lower respiratory infection or other condition causing chronic cough * condition requiring treatment with vitamin d at a dose of \> 10 micrograms vitamin d/day * episode of upper or lower respiratory tract infection up to 28 days before first dose of imp * known sarcoidosis, hyperparathyroidism, nephrolithiasis, active tuberculosis, vitamin d intolerance, liver failure, renal failure, terminal illness, lymphoma or other malignancy not in remission at time of recruitment * taking benzothiadiazine derivative, cardiac glycoside, carbamazepine, phenobarbital, phenytoin, primidone or long-term immunosuppressant therapy * taking oral preparation containing \> 10 micrograms vitamin d/day up to 2 months before first dose of imp * using topical vitamin d analogue * treatment with any investigational medical product or device up to 4 months before first dose of imp * breastfeeding, pregnant or planning a pregnancy * baseline corrected serum calcium \> 2.65 mmol/l * baseline serum creatinine \> 125 micromol/l * inability to complete symptom diary with / without assistance * cognitive impairment or communication problem precluding informed consent or successful completion of study evaluations

Keywords: bone density conservation agents cholecalciferol communicable diseases growth substances housing for the elderly infection micronutrients pharmacologic actions physiological effects of drugs respiratory tract diseases vitamins respiratory tract infections/prevention & control* vitamin d
the application of diffusion tensor imaging in the evaluation of peripheral neuropathy in anca associated vasculitis

Conditions: ANCA Associated Vasculitis

Summary: 1. include qualified 50 anca-associated vasculitis(aav) patients; and the first 27 patients will be divided into 3 groups with different diffused tension image (dti) parameters and to choose the best strategy； 2. on baseline, 6 months after treatment and 24 months after treatment, the aav patients will accomplish the birming-ham vasculitis activity score(bvas) besides dti； 3. the new serum biomarkers of aav associated peripheral neuropathy will be measured by elisa； (4) another cohort with 50 patients with aav associated peripheral neuropathy who were evaluated by traditional methods (electromyogram) and compared to the patients cohort that evaluated using dti by cost-benefit analysis


Eligibility criteria:
inclusion criteria: * age between 18-80 years old； * must fulfill 2012 criteria of anca associated vasculitis * presented with peripheral neuropathy diagnosed by specialists exclusion criteria: * the anca associated vasculitis is already in the stable stage after treatments * any vital organ dysfunction * active infection or cancer * can not finish dti scan

Keywords: peripheral neuropathy
extracorporeal shockwave on abdominal adiposity and lipid profile

Conditions: Obesity, Abdominal

Summary: almost postmenopausal women store significant extra visceral adipose tissue with unexplained mechanism, yet. postmenopausal obese women with excess abdominal obesity have raised metabolic risk of numerous cardiovascular diseases, which negatively influence health policy concern. therefore, actual need to recommend non-invasive approach that cover this lack of quantitative knowledge in clinical management of obese postmenopausal women.

postmenopausal women are usually troubled by increasing weight and waist circumference caused by obesity and androcidal fat redistribution. abdominal adiposity, defined as a waist circumference ≥88cm in women, measured in the upright position, plus significant elevated lipid profile values. in postmenopausal women, a higher level of physical activity was associated with a more optimal body composition, including lower adiposity and higher lean mass. management of abdominal obesity involves different techniques i.e., dietary management, exercise therapy, even lifestyle management, and pharmacological management, and surgical interventions. extracorporeal shockwave provides cavitation phenomena that may facilitate better management of abdominal obesity. thus, current study will be conducted to investigate effect of extracorporeal shockwave on abdominal adiposity and lipid profile in obese post-menopausal women.

Eligibility criteria:
inclusion criteria: * their age range 45-60 years old. * their body mass index range 30-35 kg/m square. * only, obese postmenopausal women with at least one year after stoppage of menses. exclusion criteria: * receiving pharmacological treatment. * receiving any form of electrotherapy. * whom with metabolic, hematological or renal dysfunction. * whom have dermatological or cardiovascular or respiratory, digestive or rheumatic disorders.
diagnostics for the treatment of progressive mucosal lesions of the oral cavity: a prospective study

Conditions: Chromosomal Instability; Low Grade Dysplasia Oral Cavity; Loss of Heterozygostiy; Fluorescence In Situ Hybridization

Summary: despite improvements in therapy, head and neck carcinomas still have a poor prognosis with a 5-year survival of \~ 50%. malignancies of the head and neck area are (almost) always preceded by precursor lesions. treatment of these premalignant mucosal abnormalities is generally limited and not very inconvenient for the patient. if this precursor lesion remain untreated, it may develop into a malignancy of the head and neck. extensive treatment will be necessary. this means loss of function of the mouth, eg chewing, speaking and swallowing. the hypothesis is that chromosomal instability (cin) detected by fluorescence is situ hybridization (fish) is a reliable indicator for progression to malignancy. by intensifying the follow up and treatment in premalignant cin lesions, the incidence of progression to invasive carcinoma is expected to be significantly reduced. if this hypothesis is justified, there will be a place for cin detection as a risk indicator in the diagnostic work up of premalignant lesions in the head and neck. the investigators second hypothesis is that loss of heterozygosity (loh) detected bij dna markers is a reliable indicator for progression to malignancy. by intensifying the outpatient clinic follow up and treatment in premalignant lesions, the incidence of progression to invasive carcinoma is expected to be significantly reduced. if this hypothesis is justified, there will be a place for cin and loh detection as a risk indicator in the diagnostic work up of premalignant lesions in the head and neck.


Eligibility criteria:
inclusion criteria: * subjects ≥18 years * premalignant lesions of the oral cavity, classified as hyperkeratosis, hyperplasia, mild or moderate dysplasia * written informed consent exclusion criteria: * former malignancy or lesion classified as severe dysplasia or carcinoma in situ at the same anatomical localization of the oral cavity * lesions within an anatomical field which has been exposed to former treatment (e.g. radiotherapy) * insufficient biopsy material to perform additional fish analysis * pregnancy, because of the physical burden (e.g. extra general anesthesia) in this study setting
blood and saliva sample collection for areds 2

Conditions: Age-Related Macular Degeneration; Eye Diseases

Summary: background: - the age-related eye disease study 2 (areds 2) is looking at different eye diseases. study participants will provide blood and saliva samples. the samples will be stored for research on eye diseases. objectives: - to collect blood and saliva samples for areds 2 research. eligibility: - areds 2 research study participants. design: * participants will provide blood and saliva samples. * the samples will be submitted with personal and medical information. this information will be collected during the areds 2 procedures.

areds2 is a multi-center, phase iii, randomized clinical trial designed to assess the effects of oral supplementation of high doses of macular xanthophylls (lutein and zeaxanthin) and/or omega-3 long-chain polyunsaturated fatty acids (lcpufas) as a treatment for age-related macular degeneration (amd), cataract and moderate vision loss. in addition to this objective, the areds2 study will provide information on the clinical course, prognosis, and risk factors for development and progression of both amd and cataract. other study goals include the evaluation of eliminating beta-carotene and/or reducing zinc in the original areds formulation on the progression and development of amd. areds2 will also seek to validate the fundus photographic amd scale developed from areds. the objective of this protocol is to have areds2 participants submit blood and saliva samples to the areds2 genetic repository (fisher bioservices, rockville, md) in order to provide further materials for the study of the genetic and biochemical bases for eye disease and possibly other diseases.

Eligibility criteria:
* inclusion criteria: participants will be eligible if they were enrolled in the areds2 protocol and willing to have their blood drawn and saliva collected. exclusion criteria: participants will not be eligible if they were not enrolled in areds2 and are not willing to have their blood drawn and saliva collected.

Keywords: age-related macular degeneration (amd) eye diseases
prevention of post-operative pneumonia (popp)

Conditions: Post-operative Pneumonia; Lung Cancer; Esophageal Cancer

Summary: postoperative pneumonia is a major complication in patients undergoing thoracic surgery. it leads to considerable morbidity and contributes to perioperative morbidity. there is evidence in literature that supports the use of strategies for improved oral hygiene and specialized endotracheal tubes in preventing ventilator associated pneumonia (vap) in mechanically ventilated patients. this study aims at utilizing a combination of these interventions in the perioperative period in patients undergoing planned thoracic surgical procedures.


Eligibility criteria:
inclusion criteria: 1. patients with lung lesions undergoing anatomic resection (lobectomy/segmentectomy/bilobectomy/pulmonary sleeve resection/pneumonectomy) 2. patients with poor lung function (fev1% \<50% or dlco\<50% predicted or home oxygen requirement) and lung lesions undergoing non-anatomic lung resection (i.e. wedge resection). 3. patients undergoing esophageal resection. exclusion criteria: 1. patients with ongoing symptomatic dental infections. 2. patients with recent/ongoing pneumonia (\<15 days from initial surgical patient evaluation). 3. patients who've received a therapeutic course of antibiotics within 15 days prior to thoracic surgery. 4. patients with a preexisting tracheostomy. 5. age\<18 6. patients with an allergy to peridex/chlorhexidine solution

Keywords: incidence of post-operative pneumonia in patients undergoing surgery for primary lung cancer or primary esophageal cancer
energy expenditure and substrate utilization during acute under- and over-feeding

Conditions: Obesity

Summary: this study will determine the impact of 24, 48 and 72 hours of over and underfeeding on energy expenditure as measured in the metabolic chamber at the unc chapel hill nutrition research institute (unc nri).

subjects will complete a baseline eucaloric study day. following this, subjects will be randomized to complete 3 days of overfeeding (150% of baseline eucaloric energy requirements) or 3 days of underfeeding (50% of baseline eucaloric energy requirements). after completing one of these study arms, subjects will cross-over and complete the second arm. all study arms will be separated by two weeks. 24-hour energy expenditure will be measured 3 times during each of 3 day periods. we hypothesize that the impact of over or underfeeding on ee will be evident after 24-hours and will be comparable to 72 hour ee.

Eligibility criteria:
inclusion criteria: * woman * postmenopausal * aged 50-65 years * bmi 25-35kg/m2 * not taking blood pressure or anti-inflammatory medications or any other medications that may impact the results * thyroid hormone profile within the normal reference range * no medical condition which may impact the results (e.g. diabetes) * accustomed to eating regular meals including breakfast exclusion criteria: * smoker * heavy exerciser (defined as \>150 minutes/week for more than 3 months) * abuses alcohol or drugs * vegetarian