Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of chronic administration of telmisartan as monotherapy or in combination with hydrochlorothiazide or other antihypertensive medications in patients with mild to moderate hypertension

Conditions: Hypertension

Summary: the primary objective of this trial was to assess the efficacy and safety of telmisartan 80 mg during open-label, long-term treatment. an additional objective was to assess the efficacy and safety of concomitant administration of telmisartan 80 mg and hctz (hydrochlorothiazide) and/or any other therapies commonly used in the treatment of hypertension.


Eligibility criteria:
inclusion criteria: * patients who have met the inclusion criteria for the preceding clinical trial of telmisartan. all patients must give a separate written informed consent for participation in the open-label follow-up. * mild-to-moderate essential hypertension defined as a mean seated diastolic blood pressure measurement of ≥ 95 mmhg measured by manual cuff sphygmomanometer * mean seated systolic blood pressure ≥ 140 mmhg, measured my manual cuff * a 24-hour mean diastolic blood pressure, measured by abpm (ambulatory blood pressure measurement), of ≥ 85 mmhg * age 18 or older * patient's written informed consent in accordance with gcp (good clinical practice) and local legislation exclusion criteria: * patients with a clinically significant change in ecg from baseline that was reported as an adverse event during the preceding clinical trial * patients who have developed a medical condition during the preceding clinical trial that, in the investigator's opinion, may be worsened by treatment or may compromise the safety evaluation of telmisartan * patients who discontinued the preceding telmisartan clinical trial due to an adverse event * any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan
preoperative maltodextrin's effect on cardiac function in cardiac surgery

Conditions: Left Ventricular Dysfunction; Quality of Recovery; Right Ventricular Dysfunction

Summary: a randomized, controlled, double-blinded clinical trial evaluating the effect of the administration of a maltodextrin solution on cardiac function in patients presenting for coronary artery bypass grafting surgery with a reduced left ventricular ejection fraction.

this randomized, double-blinded clinical trial will test the primary hypothesis that patients receiving preoperative maltodextrin will have an improved intraoperative left ventricular ejection fraction (lvef), as measured by three-dimensional echocardiography, compared to patients who receive a placebo drink. seventy patients will be recruited and randomized to each group in a 1:1 ratio. the second hypothesis is that administering preoperative maltodextrin to cardiac surgery patients enhances the quality of recovery, as measured by the quality of recovery-15 score. each patient will undergo this questionnaire 48 hours after surgery. the third hypothesis is that maltodextrin improves cardiac function by its effect on myocardial glycogen content. this will be evaluated in two ways. first, a separate group of 20 patients will undergo the hyperinsulinemic-normoglycemic clamp (hnc) to have a high-insulin level during surgery with these patients randomized to maltodextrin or placebo. in addition, 20 patients from the main study will undergo myocardial biopsies to assess the glycogen content in the maltodextrin and the placebo groups. pre-defined subgroups: * need for vasopressors or inotropes during measures of cardiac function vs no need * male versus female * diabetic versus non-diabetic * sarcopenic versus non-sarcopenic * malnourished versus non-malnourished

Eligibility criteria:
inclusion criteria: * 18 years of age or older * presenting for coronary artery bypass grafting surgery * preoperative left ventricular ejection fraction \< 50% * first case of the day (7:30am start time) exclusion criteria: * dysphagia, gastroparesis * cannot tolerate oral intake * celiac disease * type 1 diabetes

Keywords: cardiac surgery insulin maltodextrin enhanced recovery after surgery quality of recovery after surgery
topical treatment of under eye dark circles and swelling

Conditions: Edema

Summary: this study examines topical treatment of under eye circles and swelling.

this study examines topical treatment of under eyes dark circles and under eye swelling.

Eligibility criteria:
inclusion criteria: * under eye dark circles and swelling exclusion criteria: * under age 18 * allergy to tested medicines

Keywords: under eye dark circles under eye puffiness
the effects of device-guided breathing exercises on blood pressure in patients with hypertension

Conditions: Hypertension

Summary: the purpose of this study is to determine whether breathing-exercises with the resperate or listening to a discman with freely chosen music are effective in the treatment of hypertension

hypertension is an important risk factor for the development of macrovascular events. lowering blood pressure leads to a reduced risk of developing these complications. to treat hypertension effectively you can use blood pressure lowering drugs, but it is also important to use proven and safe non-pharmacological interventions. it is suggested that breathing rate and systolic blood pressure can be linked directly together by the baroreflex. with the use of the resperate, people will lower their breathing rate by breathing similar to music patterns which could theoretically lead, through the described link, to blood pressure reduction. patients will be randomize into two groups: one will get a discman with freely chosen music and the other the resperate. patients are instructed to use the breathing device or discman for 15 minutes at about the same time every day during the 9 week study period, except for the first week.

Eligibility criteria:
inclusion criteria: * over 18 years old * known hypertension with a sbp between 130-170 mmhg at previous visit to the internal outpatient department and at the last visit to the internist * treated with one or more anti-hypertensive drugs, which have not been changed for the preceding three months * at baseline the sbp should be between 140-160 mmhg exclusion criteria: * patients with known diabetes * patients with heart failure (nyha iii-iv) * patients with pulmonary disease * patients with insufficient knowledge of the dutch language to understand the requirements of the study

Keywords: high blood pressure
improving metabolism with hdl cholesterol

Conditions: Heart Disease; Diabetes

Summary: high levels of good cholesterol (hdl) in our blood decreases our chance of having a heart attack. this relates in part to the role good cholesterol plays in reducing build up of fat in the arteries. however, good cholesterol has many other protective effects. we have recently identified three enzymes (proteins) activated by hdl in cells lining the blood vessels, which may be responsible for some of hdl's protective actions.


Eligibility criteria:
inclusion criteria: * aged 18 - 65 years * free of overt coronary disease * body mass index \<35 kg.m-2 * fasting plasma glucose \> 7 mmol/l-1 * no major illness exclusion criteria: * unable to give informed consent * smokers * abnormal lft, u\&e, fbe or creatinine
optimising management of patients with heart failure with preserved ejection fraction in primary care

Conditions: Heart Failure With Preserved Ejection Fraction

Summary: heart failure (hf) accounts for 2% of national health service (nhs) expenditure, and 5% of emergency hospitalisations. patients with hf with preserved ejection fraction (hfpef) are older, have more comorbidities, have similarly poor or worse outcomes compared to patients with reduced ejection fraction (hfref), and currently lack an evidence base for treatment. the investigators hypothesise that outcomes of patients with hfpef can be improved through optimised management and self-management of comorbidities, fluid status and lifestyle delivered in primary care in collaboration with specialists. the primary aim is to develop a programme of optimised management by improving understanding of needs and experiences of patients with hfpef, clinical decision-making and management in primary care, and integrating research findings with patient and clinical expertise. the main objective for this work package is to identify patients with hfpef in primary care and assess comorbidities and other factors, management, morbidity and mortality at one year. the methodology employed will be a longitudinal cohort study of 270 patients with hfpef in primary care followed for 12 months.

this work package of the study will use phenotyping and one-year follow-up of a community recruited cohort of patients with hfpef or probable hfpef to understand the characteristics and needs of this patient group. it involves a longitudinal cohort study conducted to identify patients with hfpef in primary care and assess comorbidities, lifestyle factors, frailty, self-management, symptoms, quality of life, cognitive function, types of care received, management of risk factors and comorbidities, and one year morbidity and mortality. this will inform particular areas for assessment and management/self-management in the optimised programme. the investigators will also apply to nhs digital who are the data controllers of hospital episode statistics to check if participants have had any hospitals visits throughout the duration of the study.

Eligibility criteria:
inclusion criteria: adult patients with diagnosed or suspected hfpef (defined as: patients diagnosed with non-valvular hf that are i) not diagnosed with left ventricular systolic dysfunction or have a documented ejection fraction \ 50%, or reported diastolic dysfunction without moderate to severe systolic dysfunction) who: * have stable class i - iii new york heart association (nyha) classification for chronic heart failure * have not been hospitalised for an exacerbation of their heart failure in the 6 weeks prior to screening * are able to communicate in english (both verbally and in writing) exclusion criteria: any patients who have: * any severe neuro-psychological or neuro-cognitive conditions that would confound outcome assessment * nyha class iv classification for chronic heart failure receiving end of life care, or other life-threatening condition

Keywords: hfpef
long term follow up treatment with levetiracetam in subjects of 4 years and older with generalized epilepsy

Conditions: Generalized Epilepsy

Summary: an open-label, follow-up study to evaluate the safety and efficacy of levetiracetam (lev), in children (≥ 4 years old), adolescents and adults suffering from primary generalized seizures.


Eligibility criteria:
inclusion criteria: * male or female children, adolescents and adults having completed the final visit of a previous study with levetiracetam (lev) * subjects who were/are suffering from primary generalized (type ii) epileptic seizures * subjects for whom the investigator believes a reasonable benefit (efficacy or tolerability) from the long-term administration of lev may be expected exclusion criteria: * known clinically significant acute or chronic illness, for example: cardiac, renal or hepatic dysfunction, etc., which may impair reliable participation in the trial or necessitate the use of medication not allowed by protocol * concomitant use of any drug with possible central nervous system effects unless at a stable dose * concomitant use of any drug (other than hormonal treatment and the subject's normal anti-epileptic drugs (aeds) that may influence the metabolism of the concomitant aed(s), except if the dose has been stable before entry in the study for sufficient length of time

Keywords: generalized epilepsy, primary generalized seizures keppra, levetiracetam
a holistic dietary intervention for persons with spinal cord injury

Conditions: Spinal Cord Injuries

Summary: people with spinal cord injury are at increased risk for overweight and obesity, type 2 diabetes, cardiovascular disease and decreased quality of life compared with able bodied. this pilot aims to assess the impact of a nutrition intervention that combines several methods to help people change their lifestyle. the pilot project combines individual interviews and personal lifestyle goals (diet) with group classes for people with long-standing spinal cord injury. in addition to nutrition theory and practical exercises for diet-planning, motivational interviewing and mindfullness are incorporated into the course. the course is interdisciplinary, but is led primarily by a dietitian. data is collected before the course starts and right after the 9-week course ends. the measurements involves self-perceived quality of life, food diary, weight, waist circumference and body composition (measured by bia and dxa).


Eligibility criteria:
inclusion criteria: * \>18 years * long-standing spinal cord injury (\> 2 years after injury) * motivated for lifestyle change
the relationship of bone mineral density with balance, functional ambulation and falls in stroke patients

Conditions: Stroke Patients

Summary: the aim of this study is to investigate the relationship between bone mineral density and balance, functional ambulation and falls in hemiparetic patients with stroke in the subacute and chronic phases.

improving balance function is considered as an important method for reducing the risk of falling after stroke and protecting bone health. bone mineral density, a measure of bone health, has been reported to decrease after stroke, consistent with increased bone resorption and decreased bone formation. the aim of this study is to investigate the relationship between bone mineral density and balance, functional ambulation and falls in hemiparetic patients with stroke in the subacute and chronic phases.

Eligibility criteria:
inclusion criteria: * patients ≥ 50 and ≤ 75 years old * patients with a 10-year risk of hip fracture ≥3%, major osteoporotic fracture risk ≥20% according to the fracture risk assessment tool, frax, scoring * patients with unilateral hemiplegia as a result of first-time stroke (onset time \> 3 months) * patients who can stand for at least 2 minutes independently/under supervision for measurements while standing, and who can walk at least 10 meters independently/under supervision with or without walking aid for measurements taken while walking * patients whose cognitive status is able to understand the study instructions (mini-mental state assessment score ≥ 23) * patients with stable medical and psychological status * patients willing to participate in the study exclusion criteria: * patients with serious cardiovascular or musculoskeletal problems that prevent walking * patients with severe vision, hearing and language problems * patients with other neurological (parkinson's, epilepsy, meningitis, cerebellar disease, vertigo, dizziness, polyneuropathy, etc.) or musculoskeletal (severe low back pain, knee problems) diseases that may affect balance performance other than stroke. * patients with peripheral vascular disease

Keywords: stroke osteoporosis
acurate neo2™ post market clinical follow up study

Conditions: Aortic Valve Stenosis; Aortic Valve Calcification; Aortic Diseases

Summary: the acurate neo2 pmcf is aimed at collecting clinical and device performance outcomes data with the acurate neo2™ transfemoral aortic valve system as used in routine clinical practice for the treatment of severe calcific aortic stenosis.

acurate neo2 pmcf is a prospective, open-label, single-arm, multicenter, observational post-market surveillance study. all subjects deemed treatable with the acurate neo2 valve will be approached to participate in the study. a subject who provides an informed consent form (icf) approved by the independent ethics committee (iec) and signed by the subject or the subject's legally authorized representative is considered enrolled once an attempt is made to insert the commercially available acurate neo2 transfemoral delivery system. approximately 200 subjects will be enrolled. follow-up will occur at pre-discharge, 30 days, 1 year, and then annually from 2 through 5 years post index procedure per standard of care. visits are in-person through 1 year and in-person (preferred) or via telephone interview in years 2 through 5. all subjects will undergo 4d computed tomography (ct) imaging at 30 days and 1 year. acurate neo2 pmcf study design overview abbreviations: ct=computed tomography; icf=informed consent form

Eligibility criteria:
inclusion criteria: there are no specific inclusion criteria set for this post-market surveillance study. a subject must sign an iec-approved icf and the acurate neo2 transfemoral aortic valve system should be used according to the commercial ifu. exclusion criteria: ec1. subject has a previous bioprosthesis in the aortic position. ec2. subject has egfr \<30 ml/min (chronic kidney disease stage iv or stage v). ec3. subject has atrial fibrillation that cannot be rate controlled to ventricular response rate \< 60 bpm. ec4. subject is expected to undergo chronic anticoagulation therapy after the tavi procedure note : subjects treated with short-term anticoagulation post-procedure can be included; in these subjects the 30-day imaging will be performed 30 days after discontinuation of anticoagulation.
the effect of mother's voice and lullaby on preterm infants' physiological parameters, stress and sleeping- waking state

Conditions: Preterm Birth

Summary: the study was planned in a randomized controlled manner in order to evaluate the effect of mother's voice and lullaby on stress and sleep-wake situations of premature babies.

objective:this randomized controlled study was carried out to evaluate the effect of mother's voice and lullaby on preterm infants' stress and sleeping-waking states. study design:the study was carried out in a newborn unit in a public hospital in turkey. in this study, 90 preterm newborn were divided into three groups equally as mother's voice (n=30), lullaby (n=30) and control groups (n=30). data were obtained by mother and newborn identification form, newborn stress evaluation form (nsef) and newborn sleepıng-wakıng state evaluation form (nswef). on the 1st, 3rd and 5th days of the study; newborns' nsef and nswef scores at pre-, post-study and on the fifth minutes were evaluated. data were evaluated by using descriptive statistics, homogeneity tests, chi-square, intra-class correlation coefficent, two way of analysis on repeated measures, generalized linear model, pearson correlation analysis.

Eligibility criteria:
inclusion criteria: * 32 0/6 -36 6 weeks of gestation * not connected to respiratory support device * no surgical intervention * not receiving medical treatment other than appropriate vitamin supplements and antibiotic treatments * does not have a congenital or acquired malformation related to hearing, * can tolerate enterally given food (no nec, digestive system and chromosomal abnormalities) * the mother is at least a primary school graduate * diabetic mother without a baby • sga and no iugr exclusion criteria: premature babies who do not meet the inclusion criteria. -

Keywords: mother's voice lullaby preterm newborn stress sleep-wakefulness state
the incidence of respiratory symptoms associated with the use of hfno

Conditions: Cardiovascular Diseases

Summary: optiflow (high flow humified nasal oxygen) is used in several settings frequently (icu, during elective general anaesthesia- commonly here on the toe list, in certain ent patients, and more commonly now in obese or obstetric patients for preoxygenation). to the investigators knowledge no one has quantified the common complications associated with it (based on a literature search in november 2017 using pubmed and google; using the search terms "high flow nasal oxygen" combined with "complications", "side effects", "nasal dryness" and "epistaxis"). the investigators were unable to find any existing research that examined the days following hfno use and specifically looked for minor side effects) the investigators have had anecdotal feedback from patients that they tend to experience respiratory symptoms post hfno. the investigators would like to determine how often this occurs and how long it lasts for which would be pertinent to consent, and informing patients prior to the procedure, and also serve to improve the literature on this up and coming technique.

the study aims to evaluate what is the frequency and severity of respiratory tract symptoms following the use of high flow nasal humidified oxygen? participants will be from 2 sub groups: 1. patients already undergoing toe (as this is the most common and consistent group who have optiflow- about 4-5 patients per week) 2. volunteers (staff) who would agree to experience the optiflow whilst awake for the same period as those undergoing toe the study will involve a 7 day follow up survey to see if they had experienced complications (runny nose, nasal discomfort, sore throat, epistaxis), what their severity was and how long they lasted for.

Eligibility criteria:
inclusion criteria: 1. volunteers (staff) - from the anaesthetics department and willing to be exposed to hfno 2. patients listed for all those undergoing elective toe requiring sedation and use of hfno 3. present at torbay hospital 4. greater than 18 years of age. no upper age limit 5. able to give informed consent exclusion criteria: 1. patient refusal 2. lack of capacity 3. poor understanding of english 4. respiratory tract symptoms 5. blocked nostrils 6. current or recurrent epistaxis 7. nasal steroid treatment 8. ages \<18 years 9. unable to give informed consent
trial of low-dose xenon for the treatment of obsessive-compulsive disorder

Conditions: Obsessive-Compulsive Disorder

Summary: the primary purpose of this study is to investigate whether administration of xenon reduces symptoms of obsessive-compulsive disorder (ocd). xenon is a naturally occurring gas that has been used in clinical settings both as a general anesthetic agent and as a contrast agent for computed tomography (ct) scans. investigators believe that xenon may be effective in reducing symptoms of ocd due to its ability to reduce the activity of a specific brain chemical called glutamate, which has been shown to be abnormal in the brains of people with ocd. it is important to understand that this study uses a placebo, or inactive, treatment. in this study, the placebo treatment is inhalation of room air (instead of xenon). all participants will receive both xenon and placebo treatments at some point over the course of the study. however, neither the participants nor the study investigators will know which treatment you are receiving.


Eligibility criteria:
inclusion criteria: 1. male or female age ≥ 18 and ≤ 55 2. meets dsm-iv criteria for ocd as primary presenting disorder 3. score of ≥ 18 on the y-bocs at screening (visit 1). exclusion criteria: 1. unwillingness or inability to provide written informed consent. 2. lifetime history of schizophrenia or autism spectrum disorder 3. diagnostic and statistical manual iv (dsm-iv) diagnosis of alcohol or substance dependence, with the exception of nicotine dependence, within three months prior to screening 4. clinically significant medical disease including, but not limited to, pulmonary, cardiac (including uncontrolled hypertension), hepatic, renal, or endocrine disorders, which would increase the risk to the participant or interfere with interpretation of results as judged by the principal investigator. 5. clinically significant neurologic disease including, but not limited to, seizure disorder, neurodegenerative diseases, and history of traumatic brain injury that would increase the risk to the participant or interfere with interpretation of results as judged by the principal investigator. 6. female participants with a positive urine pregnancy test at screening 7. pregnancy. females of childbearing potential must be using an effective contraceptive method (e.g., abstinence, prescription oral contraceptives, contraceptive injections, double-barrier method, male partner sterilization). 8. any screening laboratory abnormality deemed clinically significant by the investigator