cyrilzakka/clinical-trials huggingface dataset:
Propofol and Dexmedetomidine on Inflammation

Dexmedetomidine, was reported to prevent postoperative delirium in elderly patients following its use in intensive care units. Possible mechanisms included improved quality of sleep and an inhibitory effect on inflammation. A greater number of studies indicated that propofol has negative effect on postoperative cognitive function. In this study, we planned to investigate the influence of these two different sedative drugs on peripheral inflammation induced by surgery and postoperative cognitive function of patients who will receive hip and knee arthroplasty.

Dexmedetomidine, was reported to prevent postoperative delirium in elderly patients following its use in intensive care units. Possible mechanisms included improved quality of sleep and an inhibitory effect on inflammation. A greater number of studies indicated that propofol has negative effect on postoperative cognitive function. In this study, patients who will receive hip and knee arthroplasty will be divided to two groups: Propofol group and Dexmedetomidine group. Spinal anesthesia will be used to meet the requirement of intraoperative analgesia. Patients in two groups will be sedated by propofol and dexmedetomidine, respectively. TNF-α and IL-6 in blood will be detected. And postoperative cognitive function of patients will be investigated. The objective of this study is to clarify the influence of these two different sedative drugs on peripheral inflammation induced by surgery, and the relationship with the change of postoperative cognitive function.

Eligibility Criteria:
Inclusion Criteria:

* The patients included in this study were 65 years or older, were undergoing total hip arthroplasty, and were classified as American Society of Anesthesiologists (ASA) physical health class I-IV.

Exclusion Criteria:

* Contraindications to spinal anesthesia (i.e., coagulopathy, concurrent use of anticoagulants, infection at puncture site, and refusal of spinal anesthesia), patients with infectious diseases, patients with mental or language barriers, patients who had been anesthetized within the past 30 days, severe congestive heart failure (New York Heart Association, class IV) and/or severe chronic obstructive pulmonary disease (Global Initiative for Chronic Obstructive Lung Disease Guidelines, stages III-IV), sick sinus syndrome, severe sinus bradycardia (\< 50 beats per min), and second or greater atrioventricular block without pacemaker. In addition, patients exhibiting cognitive impairment (i.e., a Mini-Mental State Examination (MMSE) score \< 24) and/or preoperative delirium (i.e., positive Confusion Assessment Method (CAM) result) were excluded.
EINSTEIN Junior Phase II: Oral Rivaroxaban in Young Children With Venous Thrombosis

The purpose of this study is to find out whether rivaroxaban is safe to use in children and how long it stays in the body. Safety will be assessed by looking at the incidence and types of bleeding events. There will also be a check for worsening of blood clots.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 6 months to \< 6 years who have been treated for at least 2 months or, in case of catheter related thrombosis, for at least 6 weeks with LMWH (low molecular weight heparin), fondaparinux and/or VKA (vitamin K antagonist) for documented symptomatic or asymptomatic venous thrombosis - Hemoglobin, platelets, creatinine, alanine aminotransferase (ALT) and bilirubin evaluated within 10 days prior to randomization
* Informed consent provided

Exclusion Criteria:

* Active bleeding or high risk for bleeding contraindicating anticoagulant therapy
* Symptomatic progression of venous thrombosis during preceding anticoagulant treatment
* Planned invasive procedures, including lumbar puncture and removal of non peripherally placed central lines during study treatment
* An estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m\^2
* Hepatic disease which is associated with either: coagulopathy leading to a clinically relevant bleeding risk, or ALT\> 5x upper level of normal (ULN) or total bilirubin \> 2x ULN with direct bilirubin \> 20% of the total
* Platelet count \< 50 x 10\*9/L
* Hypertension defined as \> 95th age percentile
* Life expectancy \< 3 months
* Concomitant use of strong inhibitors of both cytochrome P450 isoenzyme 3A4 (CYP3A4) and P-glycoprotein (P-gp), i.e. all human immunodeficiency virus protease inhibitors and the following azole antimycotics agents: ketoconazole, itraconazole, voriconazole, posaconazole, if used systemically
* Concomitant use of strong inducers of CYP3A4, i.e. rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine
* Hypersensitivity or any other contraindication listed in the local labeling for the comparator treatment or experimental treatment
* Inability to cooperate with the study procedures
* Previous randomization to this study
* Participation in a study with an investigational drug or medical device within 30 days prior to randomization
Prospective Study of Dietary Factors, BMI, and Risk of Asthma in Children

Asthma is a common illness among children in the United States. While there are many known causes of asthma, including tobacco smoke, pollen, dust, or other allergens, the exact cause of asthma in some individuals remains unknown. This study will examine the role that specific dietary factors and body mass index (BMI) play in the development of childhood asthma.

Asthma prevalence has steadily increased in the United States since the early 1980s, but the exact cause of this increase remains unknown. It is estimated that at least 8% of Americans have asthma. Although anti-inflammatory medications have proven effective for decreasing asthma exacerbations, there are few treatment options available to prevent the initial onset of the disease. Dietary factors and BMI may play a role in the development of asthma. Specifically, individuals who eat foods containing antioxidants (e.g., vitamin C, vitamin E, and carotenoids), n-3 polyunsaturated fatty acids (e.g., fish oils), and vitamin D may have a decreased risk of developing asthma, while individuals with higher BMI ratios may have an increased asthma risk. The purpose of this study is to evaluate the relationship among dietary factors, BMI, and the incidence of asthma among children.

This study will enroll children participating in the Growing Up Today study and children of nurses who are participating in the Nurses Health Study II. Researchers will analyze participants' previously completed questionnaires on dietary intake, physical activity, height, weight, and the presence of physician-diagnosed asthma. All participants with physician-diagnosed asthma will receive an additional asthma questionnaire. A small portion of these participants will also have their medical records reviewed by study researchers, and mothers of these children will be asked to complete a questionnaire. Additionally, a questionnaire will be sent to and completed by children who do not have asthma and their mothers.

Eligibility Criteria:
Inclusion Criteria:

* Children of women in the Nurses Health Study II (NHS2)
* Participated in the Growing Up Today study

Exclusion Criteria:

* None
An Open-label Trial to Determine Increased Red Blood Cell Production in Subjects With Anemia of Chronic Disease

The objective of this study is to measure the change in blood values after the administration of an amino acid based erythropoietin stimulating system.


Eligibility Criteria:
Inclusion Criteria:

1. M/F patients 18 years old and over, non-pregnant/lactating
2. Hemoglobin \< 10 female,\<11 male
3. Ferritin \> upper limit of normal for lab indicative of chronic anemia
4. Anemia of chronic disease
5. Crt. \< 3.0

Exclusion Criteria:

1. Currently taking other amino acid formulations.
2. Pregnant or unwilling to use adequate birth control for the duration of the study.
3. Excessive alcohol or illicit drug use.
4. Unwilling or unable to sign informed consent.
5. Myocardial infarction within the last 6 months.
6. Patients ever having taken or currently taking an erythropoietin medication.
7. Iron deficiency (add criteria).
8. On dialysis.
9. Malignancy other than non-melanoma skin cancer within the last 5 years. If has such malignancy, must have documentation of no recurrence for at least 5 years.
10. Liver cirrhosis (add criteria).
Postoperative Analgesia After Laparoscopic Living Donor Nephrectomy

The aim of the study is to investigate if perioperative administration of pregabalin vil reduce postoperative pain and the postoperative need for intravenous opioids compared with todays standard treatment which consist of paracetamol, corticoids and ketobemidone.

In addition potential sideeffects as sedation and effect on cognitive function will be recorded.


Eligibility Criteria:
Inclusion Criteria:

* \>18, \< 75 years
* healthy patients accepted for laparoscopic living donor nephrectomy

Exclusion Criteria:

* not familiar to the Norwegian language (spoken and written)
* allergic to one or more of the medication given in the study
Nurse Smoking Cessation of Patients With Chronic Obstructive Pulmonary Disease (COPD) With Nicotine Replacement Therapy (NRT) and Behavioral Support

This is a smoking cessation study with COPD patients where the researchers wanted to evaluate if nicotine sublingual tablets or placebo combined with low or high individual support could increase ½ and 1 year quit rates.

Placebo, controlled, randomized, double-blind trial with 400-1000 smoking COPD patients with FEV-1 \< 90 % predicted normal with the use of nicotine sublingual nicotine tablets or placebo for 12 weeks combined with individual clinic visits with low or high intensity conducted by trained nurses in several centres in pulmonary clinics in Denmark. Outcome was smoking cessation and smoking reduction after ½ and 1 year as self declared smoking status confirmed by carbon monoxide in expired air\< 10 ppm. Secondary outcomes were change in body-weight, quality of life (SF-36 and SGRQ), symptoms, lung function, adverse events.

Eligibility Criteria:
Inclusion Criteria:

* COPD patients (FEV1/FVC\<70% and FEV1\<90 % predicted)
* Smoking 1 cigarette daily or more
* Willing to follow the protocol

Exclusion Criteria:

* Used NRT or bupropion the last week
* Not able or willing to adhere to the protocol
* Estimated survival \< 1 year
Assessment of Bullying in Children

The specific aims of this study are:

* To determine the prevalence of bullying in children who present to the ED with behavioral symptoms
* To assess mental health diagnoses and their relationship to type, severity and frequency of bullying behaviors, as well as demographic and psychosocial correlates (socioeconomic status, stress and support) and their relationship to type, severity and frequency of bullying (bullies versus victims).
* To explore the attitudes, values, triggering events and potential solutions using qualitative methods
* To gain greater insight into the patient experience and perceptions of the bullying events

This is a mix method study which has both qualitative and quantitative components.

* Data Collection sheet
* Qualitative Measurement
* Quantitative Measurement
* Data Collection sheet

  1. Demographic information (Date of birth, gender, race/ethnicity)
  2. Assessment of socioeconomic status (Type of Insurance, Zip Code, Parent education level, Parent type of work)
  3. Child physical attributes (Appearance, Weight, Height, Percentiles \& BMI, Assisted Devices, Disabilities)
  4. Academic performance (Whether grades are age appropriate, previous grade results
  5. Extra-curricular activities (Questions include do you participate in sports? Are you member of any sport team? Are you member of any club?)

Qualitative Measurement

In order to understand bullying and victimization, a brief qualitative interview will be conducted by the principal investigator and his team. These questions may provide insights into the dynamics of bullying.

Quantitative Measurement

Following measurement scales will be used in the assessment of children with bullying Bullying → Olweus Bullying Questionnaire Child behavior → Achenbach Child Behavior Checklist Stress, life events and adversities → Adolescent Perceived Events Scale (APES) Social support → Child and Adolescent Social Support Scale (Malecki 2000) Social status → MacArthur Scale of Subjective Social Status Family Structure → A documentation of family structure and dynamics Mental health status → Psychiatric evaluation

Eligibility Criteria:
Inclusion Criteria:

* Children with psychiatric or behavioral problem(s) age 8-18 years referred from the school to the ED
* Parents willing to provide informed consent and child providing assent

Exclusion Criteria:

* Actively violent behavior
* Child abuse
* Parents or children refuse to participate
A Study Evaluating Biomarkers in Participants With Heart Failure (MK-0000-344)

The aim of this 2-part study is to assess B-type natriuretic peptide (BNP) as well as other circulating and imaging biomarkers in myocardial function. Part 1 assesses biomarker levels in healthy participants and participants with cardiac dysfunction. Part 2 assesses BNP and other circulating biomarker levels, and performs imaging in participants with cardiac dysfunction who continued from Part 1. The primary hypothesis is that compared to healthy participants, biomarker levels are elevated in participants with mild/moderate and severe cardiac dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* female of reproductive potential must demonstrate non-pregnant state, and agree to use two acceptable methods of birth control
* postmenopausal or surgically sterile female
* have a Body Mass Index (BMI) \>= 18 and =\< 35 kg/m\^2, inclusive
* healthy participants are in general good health
* participants with HF have no untreated, significant health issue from other co-morbidities, e.g. uncontrolled hypertension
* is willing to undergo echocardiography, CMR, and other study assessments
* participants with HF have a diagnosis of cardiomyopathy, and slight to moderate limitation of physical activity, but are comfortable at rest
* participants with HF are on a stable medical therapy for HF for two weeks prior to start of Part 1
* participants with HF are on a stable diuretic regimen of \>= 40 mg/day furosemide or \>= 10 mg/day torsemide for at least 2 weeks prior to start of Part 1

Exclusion Criteria:

* has any clinically significant, uncontrolled renal, endocrine (except Type II Diabetes), neurological, hepatic, immunological or inflammatory disease
* has a history of cancer (malignancy)
* had major surgery or donated/lost approximately 500 mL of blood within 4 weeks prior to screening
* participated in another investigational trial within 4 weeks prior to screening
* excepting permitted medications, uses prescription, or non-prescription drugs or herbal remedies 2 weeks prior to enrollment until completion of trial
* takes medications that affect BNP levels within 30 days prior to screening
* undergoes high-intensity physical exercise from 1 week prior to pretrial visit until completion of trial
* has implanted or embedded metal objects in body that in response to a magnetic field could cause injury
* suffers from claustrophobia making them unable to undergo CMR scanning
* consumes alcohol for 7 days prior to screening until completion of study
* consumes excessive amounts of caffeinated beverages
* uses cannabis regularly, or any illicit drugs, or has a history of drug (including alcohol) abuse within prior 12 months
Immediate Effect of Hamstring Stretching in Patients With Chronic Low Back Pain

Thigh muscles flexibility deficits contribute to handicap in chronic low back pain patients. The study aims to evaluate the immediate effect of thigh muscles stretching in patients with chronic low back pain. The investigation team suppose that flexibility improvement could be detected by instrumented clinical measurements and such difference could be related to psycho-social factors evaluated by questionnaires.

The primary objective of the study is to evaluate the immediate effect of the hamstring muscle stretching in patients presenting chronic low back pain. The secondary objectives are: (1) to evaluate intra- and interrater reliability, construct validity and responsiveness of the hamstring flexibility measurements (Active Knee Extension \[AKE\], Straight Leg Rise \[SLR\]) realised with digital inclinometer, (2) to evaluate factors that potentially could influence immediate effect of the hamstring stretching, specifically psycho-social factors Fear Avoidance Belief Questionnaire (FABQ), Hospital Anxiety and Depression scale (HAD), neuropathic pain presence (DN4).

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 60 years
* Chronic low back pain (\>3 months) with or without pain irradiation to lower limb
* Hamstring flexibility deficit (AKE \<80° and FTF\>5cm)

Exclusion Criteria:

* Pregnancy or breastfeeding,
* Condition of restricted mental/legal autonomy (ex. guardianship) ,
* No social security insurance,
Regular Consumption of High Phytate Reduces Inhibitory Effect of Phytate on Iron Absorption

The purpose of this study is to investigate whether regular consumption of phytate dampens its negative effect on nonheme iron absorption.

Phytate is one of the main inhibitors of nonheme iron absorption. High phytate consumption is of concern in developing countries because of the high prevalence of iron and zinc deficiency in these countries. In this study, we investigated the effect of habitual consumption of a high phytate diet on the inhibitory effect of phytate on nonheme iron absorption. Thirty-two non-anemic female subjects with ferritin ≤ 30µg/L were randomized into two groups, after matching for ferritin concentration. Each group consumed either high or low phytate foods that were provided for 8 wk. Iron bioavailability from a high phytate test meal was measured using area under the curve (AUC) for serum iron at baseline and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Marginal iron status (Serum ferritin \<30ug/L)
* BMI in the range 18.5-24.9kg/m2
* Willing to modify diet to increase or decrease phytate intake
* Willing to give multiple blood samples at beginning and end of study

Exclusion Criteria:

* Pregnant
* Lactating
* Smoker
* Anemic (hemoglobin \<120 g/L)
* Has gastro-intestinal disease/condition that can affect absorption
Relative Efficacy of Vitamins D2 and D3 in Adult Humans

Vitamin D2 in chronic dosing will produce less of an elevation of serum 25(OH)D than will the same dose of vitamin D3.


Eligibility Criteria:
Inclusion Criteria:

* willingness to withhold supplement use for duration of study
* willingness to avoid sun exposure for duration of study

Exclusion Criteria:

* vitamin D supplement use
* conditions that affect vitamin D metabolism by the body
Effects of Losartan on Hepatic Fibrogenesis in Chronic Hepatitis C

There is evidence on the beneficial effects of the administration of angiotensin II type 1 (AT1) receptors antagonists on liver fibrosis in hepatic stellate cells, experimental models of liver fibrosis in rodents and limited information in chronic hepatitis C with mild fibrosis.

The purpose of this study is to investigate the effect of long-term administration of oral Losartan, an AT1 receptor antagonist, on liver fibrogenesis in patients with chronic hepatitis C and fibrosis F2-F3 (METAVIR score).


Eligibility Criteria:
Inclusion Criteria:

* age between 35 and 65 years
* chronic hepatitis C with intermediate fibrosis (F2-F3 in Metavir score).
* non-responder or contraindication to antiviral therapy.

Exclusion Criteria:

* any other cause of liver disease
* HIV positive
* alcohol consumption
* arterial hypertension
* creatinine \> 1.5mg/dL
* treatment with AT1 receptor antagonists or angiotensin converting enzyme inhibitors in the past 12 months.
* antiviral therapy in the past 12 months
* contraindications to oral losartan
Calligraphy Writing for Cognitive and Emotional Enhancement Among Older MCI People

This study is aimed to investigate the efficacy of an 12-week Chinese calligraphy training program for enhancing cognitive and emotional functions of older adults with mild cognitive impairment. Participants are tested with several cognitive tests and electroencephalography (EEG), psycho-physical parameters and brain activities are recorded. Results are compared at pre-intervention, post-intervention, and 6-month post-intervention to provide evidence of benefits of Chinese calligraphy practice.

Participants are older adults with mild cognitive impairment, who will be recruited from several community elderly centers in Hong Kong according to selective criteria. The participants are randomly assigned to an experimental or a control group. The experimental group is invited to participate in 16 sessions of structured Chinese calligraphy program over 12 weeks. Each session lasts for 1.5 hours. The control group is invited to participate in an iPad learning program with navigating the Internet. The iPad program is also consisted of 16 sessions of 1.5 hours each over 8 weeks. Cognitive tests and physiological measures are conducted immediately before and after intervention and at 6-month post-intervention follow-up. Statistical analysis are performed to investigate the significant differences and interactions among the three time points. The association of cognitive performance and emotional calmness is also investigated.

Selected participants are invited to take part in a EEG session while doing some computer tasks related to Chinese calligraphy. EEG results of are used to explore neural activities associated with visuospatial working memory and to provide evidence for neural changes at functional level as a result of Chinese calligraphy training and practice.

Eligibility Criteria:
Inclusion Criteria:

* Meeting Petersen's criteria for mild cognitive impairment
* Being able to read simple Chinese characters
* Community-dwelling
* Clinical Dementia Rating score of 0.5
* No substantial prior experience of calligraphy writing
* Willing to write using a brush and willing to participate

Exclusion Criteria:

* Presence of musculoskeletal problems preventing participants from writing
* Known chronic cardiovascular (e.g. systolic BP \> 140mmHg) or pulmonary conditions requiring long-term medication
* Presence of severe mental disorder such as psychosis or depression.