cyrilzakka/clinical-trials huggingface dataset:
Intra-rater Reliability and Agreement Between Two Dual Task Tests; WBB and Gait Test.

Agreement and intra-rater reliability between static balance test using Nintendo Wii Balance Board and gait test under dual-task conditions in community-dwelling older adults.

Participants:

Investigators aim to recruit a minimum of 30 participants aged 65 years or above through convenience sampling at an senior activity centre in the Municipality of Aalborg. Participants inclusion critiria is age about 65, the ability to stand for 30 seconds unaided and the ability to walk 8 meters. Exclusion critiria is severe cognitive impairment (e.g., dementia).

Procedure:

Each participant will undergo two testdays separated by approximately two weeks. Both testdays have the same number and order of tests and are placed approximately the same time of the day. At the first testday descriptive information for each participant is collected.

Measuring device:

The Nintendo Wii Balance Board (Nintendo, Kyoto, Japan) is a small portable force plate measuring sway ellipse area and sway speed.

Analysis:

Will include intra-rater reliability for each test and agreement between the two. Calculations of balance/gait costs will be made to unify the unit and to compare the two tests to each other. Results shown by intraclass correlation coeffients and Bland Altman plots.

Eligibility Criteria:
Inclusion Criteria:

* Minimum 65 years old.
* Community dwelling

Exclusion Criteria:

* Unable to stand unsupported for 30 seconds
* Unable to walk 8 meters unsupported
Characterizing Cognitive Decline in Late Life Depression: The ADNI Depression Project

The purpose of this research study is to characterize the mechanisms contributing to cognitive impairment and accelerated cognitive decline in Late Life Depression (LLD).

This is a non-randomized, observational, non-treatment study that originally launched in 2015, enrolling 133 participants. From the originally enrolled participants, the continuation of the ADNI-D study will enroll 120 participants which will include following participants from the original (parent) protocol and enrollment of new participants for a period of 30 months. Data from an additional 300 non-depressed subjects will be used from ADNI studies for comparison.

Depression history, symptom severity and health information will be collected at the initial visit to determine eligibility. An magnetic resonance imaging (MRI) scan, as well as amyloid (florbetapir) and tau (flortaucipr) positron emission tomography (PET) imaging will be conducted at San Francisco VA. Collection of plasma and serum for biomarkers, clinical assessments and cognitive assessments will be conducted at two time points. Blood samples will also be collected for genetic analysis.


Eligibility Criteria:
Inclusion Criteria:

1. Individual participated in original Characterizing Cognitive Decline in Late Life Depression study or Multimodal MRI Characteristics of Psychotherapy Response in Late Life Depression Study.

Exclusion Exceptions:

1. Antidepressant medication treatment is allowed only if the medication dose is stable for 4 weeks prior to the MRI scan.
2. Psychotherapy interventions is allowed only if they have completed at least 4 weeks of individual or group psychotherapy intervention prior to the MRI scan.
3. Participants taking cognitive enhancing medications will be able to enter the study.
LH Response to GnRH Test in Prepubescent Girls Under 6 Years

The project aims to establish the normal LH and FSH response to a standardized GnRH dose in healthy girls below 6 years of age, and compares the normal GnRH response to the GnRH response in girls with early puberty development.

The novel data may help to determine whether the girl is in early puberty or not.

Healthy girls under 6 years of age attending routine examinations including an i.v. line for other causes are included in this study. Our examinations also include bone age determination, Tanner stage determination, and anthropometric measures (height and weight). 10 healthy girls in each of the following age groups: 7-12 months, 12-24 months, 24-36 months, 36-48 months, 48-60 months and 60-72 months are included.

Please refer to the brief summary which covers the study aim, methods and outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* Endocrinologically healthy girls in the age from 7 months to 6 years
* Obtained oral and written informed consent from participants parents

Exclusion Criteria:

* Anamnestic, clinical or laboratory findings that indicate that the subject is suffering from other diseases (eg poorly controlled asthma) or is in a condition which might affect the subject's ability to complete the study or which is likely to affect the parameters under investigation.
* Current medical treatment apart from prophylactic antibiotics or weak analgesics.
* GFR \<50 ml/min/1,73m2 or if absence of previous GFR study: serum creatinine above normal upper age-specific normal range.
* Clinical signs of precocious puberty
Family Activation and Communication About Errors and Safety (FACES)

Miscommunications are a leading cause of serious medical errors in hospitals, contributing to more than 60% of sentinel events, the most serious adverse events reported to the Joint Commission. Efforts to improve patient safety in hospitals have centered on improving communication between providers. While provider-focused communication interventions have led to reductions in patient harm, patients and families have been notably absent from most interventions to improve patient safety. This proposal seeks to develop a family safety reporting intervention.


Eligibility Criteria:
Inclusion Criteria:

* Primary caregiver of a child hospitalized on the study units during the study period or hospital employee who works on the study unit(s)
* Country of Origin: United States
* Primarily English- or Spanish-speaking

Exclusion Criteria:

* International patients
Genetic Determinants of the Response to Salbutamol Among Asthma Patients

The response to salbutamol varies greatly among individuals. Data from previous studies indicate that some of the variability is accounted for by genetic polymorphisms in the gene encoding for the adrenoceptor subtype β2. The current study was designed to evaluate variability in the response to salbutamol among recently diagnosed patients who have not been treated by β2 agonists or corticosteroids.

Lung function tests will be performed prior to and following a single dose administration of salbutamol through inhalation. Additional pharmacodynamic indices will be monitored including pulse and blood pressure. Three samples of plasma will be drawn for the evaluation of salbutamol plasma concentration.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Recently diagnosed as asthmatic

Exclusion Criteria:

* Current treatment by β2 agonist
* Current treatment by corticosteroids
* Acute asthma attack
Effect of Prevention Education in Caries Formation in Pediatric Patients With Leukemia

This randomized pilot clinical trial studies how well preventive education works in decreasing caries formation in pediatric patients with leukemia. Prevention education may have an effect on factors important in causing cavities in pediatric patients with leukemia.

Patients treated for leukemia at Virginia Commonwealth University Medical Center in the department of Pediatric Hematology and Oncology are currently receiving oral hygiene instruction at diagnosis. In this study, patients will be randomized into two groups at diagnosis: one receiving current prevention education and the other group receiving one-on-one prevention education and counseling with the physician and pediatric dental resident. Physician and pediatric dental resident will use motivational interviewing informed techniques during counseling. A caries risk assessment will be performed for each patient at diagnosis. Caries incidence, plaque scores, mutans streptococci levels, salivary flow rate, and salivary pH will be assessed at week one (diagnosis), week 16 or start of interim maintenance therapy whichever comes second, week 32 or beginning of maintenance therapy whichever is later for all patients enrolled in the study. Data will be collected through a clinical intraoral examination and salivary sample. Data collected will be used to assess the effect of increased prevention education on factors of importance in caries formation.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients who have been recently diagnosed with leukemia
* Patients will also predictably be in primary or mixed dentition
* Patients of Virginia Commonwealth University Medical Center Pediatric Hematology Oncology Clinic

Exclusion Criteria:

* Full permanent dentition
* Primary language is not English
* Children in the custody of the state with no parent or legal guardian present to sign consent
An Investigator-blind Multi-center Prospective Study for the Efficacy and Safety of Silicon Gel (Dermatix)

Silicone gel is a self-drying silicone polymer that forms thin film after application onto the skin. Because silicone film is a medical device, silicone gel is also regarded as a medical device. Silicone gel has been on the market for many years for the management of scar in the phase of treatment as well as in the phase of prevention. In contrast to other methods that are expensive, invasive or inconvenient, silicone gel is convenient, non-invasive and also reasonably priced. However, the number of well-designed clinicial trials for efficacy and safety are not enough to provide robust evidences in making clinical decisions for scar management options. In a prospective, multi-center, investigator-blind randomized half-split study for patients undergoing cesarean sections, the investigators attempt to provide valid information for the efficacy and safety of silicone gel in the prevention phase of scar.

Prospective subjects will be enrolled in the trial when eligibility screening and informed consent were made. One day after stitch out for cesarean sections, subjects will be asked to start applying silicone gel as the instruction to the randomly designated half of the wound 2 times a day for 12 weeks. Subjects are asked to make visits on week 4, 8, and 12 for efficacy, safety and compliance evaluations. Obstetricians, dermatologists and medical imaging specialists are involved in the trial for the evaluation of efficacy, safety and compliance. Sample size calculation as well as statistical analysis will be conducted by a designated statistician. Study product will be provided by the manufacturer at no cost and patient visits and relevant lab exams will be conducted free of charge.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant female of 20-45 in ages equal to or beyond 34th of pregnancy
* Those who understand and agree on the trial conditions

Exclusion Criteria:

* Keloid (by present and past medical history)
* Secondary infection, and/or dermatitis in and around c/s wound
* Hypersensitivity to the study agent
* Diabetes
* (Pre)eclampsia
Non-Contact Monitoring of Subjects With an Optical Device: A Pilot Usability Study

This is a single-center, prospective study in subjects visiting TASMC for various indications.

This study will be divided into two arms:

First Arm - Subjects measured by the study staff via the investigational device at the hospital (up to 50 subjects).

Second Arm - subjects measuring themselves autonomously with the investigational device at their homes (up to 10 subjects from the first arm).

Hence, total number of subjects for the study will be up to N=50. All subjects will be enrolled to the study only after signing an informed consent form.

Specifically for the second arm, subjects will undergo proper training by the sponsor's representatives prior to being discharged from the hospital. Training will focus on proper operation of the device, which is also designed for autonomous use in a simple and user-friendly manner. Subjects will be asked to monitor themselves periodically for a duration of up to a week. Ongoing support will be provided by the sponsor upon subject request, either by phone, or on-premise via a dedicated support team.

For both arms, device users (either study staff in first arm or subjects in the second arm) will be requested to answer questionnaires in order to assess usability with the investigational device. In both cases, a dedicated sponsor representative will observe the users to gather objective usability data, and aid in the questionnaire filling process.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years of age, male or female
* Hemodynamically stable as assessed by the investigator

Exclusion Criteria:

* Inability to comply with study protocol as assessed by the study staff (e.g. currently suffering from tremors, afraid of using tech-based devices etc.)
* Inability to provide informed consent
* Parallel participation in another clinical study
Management Strategy for Acute Cholecystitis in the Digestive Surgery Department and Geriatric Unit in Subjects Over and Under 75 Years

The management of these often frail elderly patients, with more comorbidities and declining functional capacities, is more complex and justifies a specific, tailored approach.

Age is also associated with an increasing prevalence of gallstones. The disadvantages of "cold" surgery (longer hospital stay, higher cost, risk of disease recurrence in the interim, difficult surgery with more scar tissue due to repeated inflammation) have to be weighed against the high operative risk in the case of emergency surgery, leading to strict criteria for early cholecystectomy.

These criteria are rarely met in geriatric patients, who thus enter a hospital cycle whose impact on morbidity and mortality, as well as on loss of autonomy, has been demonstrated in this population. What's more, the deteriorating general condition of frail elderly patients means that a number of them end up being definitively rejected for surgery, despite an initial strategy of cold cholecystectomy.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age.
* Diagnosis of acute cholecystitis.
* Hospitalization in the digestive surgery department and geriatric perioperative unit of Nîmes University Hospital.

Exclusion Criteria:

* Patients under 18 years of age.
* Opposition of the patient to his inclusion in the study after sending the letter of information and non-opposition.
Clinical Trial of L. Reuteri in Urinary Tract Infections in Non Pregnant Women

RCT to evaluate the safety and efficacy of Lactobacillus reuteri DSM 16666 \& Lactobacillus reuteri DSM 17938 to significantly modify the frequency of clinical or bacteriological cure in women with non complicated acute cystitis who receive probiotics for 12 days compared with the frequency in women who receive placebo.

Randomized, double blind, placebo controlled, pilot trial to evaluate the safety and efficacy of L. reuteri in non menopausal women with non complicated cystitis in terms of the frequency of clinical or bacteriological cure. Secondary outcomes will be a) time to clinical/laboratory relapse in at least 70% of women with non complicated acute cystitis who receive probiotics for 12 days compared with the time in women who receive placebo; b) frequency of clinical/laboratory and bacteriologic relapse in women with non complicated acute cystitis who receive probiotics for 12 days compared with the frequency in women who receive placebo, at day 30 after treatment start and c) frequency of adverse related events in women with non complicated acute cystitis who receive probiotics for 12 days compared with the frequency in women who receive placebo. In the active product we will use 5\*10\^8 CFU of Lactobacillus reuteri DSM 16666 \& Lactobacillus reuteri DSM 17938 + cranberry extract. The control group will recibe Cranberry extract. The products will be taken twice per day, morning and evening.

Eligibility Criteria:
Inclusion Criteria:

* Non pregnant pre menopausal women
* Minimum age 18 years
* Uncomplicated cystitis diagnosed by urine dipstick testing (nitrates +, leukocytes esterase

  * and/or 105 CFU/ml or nitrates +, leukocytes esterase + and/or 102 -103 CFU/ml+ clinical symptoms) and an evaluation of the presence of typical related symptoms. In particular, frequency (frequent voiding of urine), urgency (the urge to void immediately), dysuria (painful voiding), and/or suprapubic pain.
* Verbal and Written Informed Consent for participation in the study

Exclusion Criteria:

* Acute cystitis symptoms for \>1week before the first visit
* Diabetes mellitus,
* Congenital urinary tract abnormality
* Lactating women
* Female who intend to become pregnant during the study or within 3 months after the completion of the study
* Vaginal discharge + fever (\>37.5oC)
* Diagnostic of sexually transmitted diseases
* Use of an indwelling catheter or an intermittent self-catheterisation program
* Presence of neurogenic bladder, or
* Use of any antibiotic 2 weeks before Day 1 in the study.
GWAS to Identify Predictive Genetic Factors for the Success of Dietary Intervention in the Treatment of IBS Symptoms

This is a GWAS that aims to identify possible single nucleotide polymorphisms (SNPs) that are associated with the response in a combined dietary pattern low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols and Meditteranean diet (MED-LFD) in a small group of patients with Irritable Bowel Syndrome (IBS).

Irritable bowel syndrome (IBS) is a very common chronic gastrointestinal disorder. Several factors seem to contribute to its development, such as psychological stress, intestinal dysbiosis, infections, post-traumatic syndrome and genetic predisposition. Regarding the nutritional management of IBS, there are several approaches to alleviate symptoms, such as the low-fructose diet low in fermentable oligosaccharides, disaccharides, monosaccharides and FODMAP polyols (LFD), recommendations from the British Institute of Health and Care Excellence (NICE) and the recently proposed combination of the Mediterranean diet and LFD (MED-LFD) proposed by our Research Group. However, genetic background expressed in single nucleotide polymorphisms (SNPs) appears to influence the response to even dietary interventions.

The aim of this GWAS is to identify SNPs that are associated with the negative or positive response to the diet.

At the baseline, blood samples will be collected for DNA extraction. Genotyping will be based on Next Generation Sequencing (NGS) technology to detect genetic factors associated with the effectiveness of the intervention. Symptom severity will be measured by the IBS-SSS scale. Mental health status will be assessed with the HADS (Hospital Anxiety and Depression Scale) questionnaire.

Patients will be recruited by the Department of Clinical Nutrition, Attikon University General Hospital, where the nutritional intervention will be carried out.

Eligibility Criteria:
Inclusion Criteria:

* Fulfillment of the Rome IV criteria for IBS
* Provision of written informed consent.
* Commitment of availability throughout the study period.
* IBS-SSS \> 175

Exclusion Criteria:

* Any concomitant disease requiring specialized nutrition (e.g. renal failure, diabetes, celiac disease, cerebrovascular disease of the central nervous system, major surgical cavity).
* Pregnancy.
* Breastfeeding.
Stereotaxis Idiopathic Ventricular Tachycardia (VT) Study

This study will assess the outcomes of using magnetic navigation to treat ventricular tachycardia (VT) or premature ventricular contractions (PVCs) that occur for unknown reasons and are not related to structural heart disease.

During conventional ventricular arrhythmia ablation procedures, simply contacting the cardiac wall can significantly alter the electrocardiogram. Induction of ventricular ectopy is important in determining the focus of the arrhythmogenic tissue during an electrophysiology (EP) procedure; however, instrumentation with stiff ablation catheters can temporarily eliminate VT during the mapping portion of the procedure making it difficult to track the arrhythmia prior to ablating the tissue responsible for its genesis. The catheters used with the Stereotaxis Magnetic Navigation System (MNS) are less stiff compared to manual catheters since no pull wires are required to deflect the distal tip. Large external magnets positioned on either side of the EP procedure table create a magnetic field within the patient's chest. These large magnets (in direct relationship to the magnetic field) can be manipulated using specialized software. The physician controls the distal tip of the catheter by using the software while remotely using a catheter advancing system (QuickCAS®, Stereotaxis, Inc, St. Louis, MO) to reach the desired location within the heart. The soft catheters may provide a unique quality to the electrophysiologist who may assist by providing accurate maps without temporarily eliminating the ventricular ectopy due to excessive mechanical forces applied to the cardiac tissue. This study will assess the physician's ability to appropriately map and ablate the ventricular substrate using remote magnetic technology. All devices are approved by FDA and no off-label use of the products is mandated within the protocol.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be between 18 - 80 years of age
* Willing to provide written informed consent
* Present with ventricular ectopy of non-ischemic origin
* able to be safely exposed to a static magnetic field
* Failure of at least 1 antiarrhythmic medication

Exclusion Criteria:

* Presence of a mobile ventricular thrombus
* Unable to obtain percutaneous access to the left ventricle
* Contraindicated for short-term anticoagulation therapy
* Life expectancy less than 1 year
* Body habitus limits placement on the procedure table
* Previously failed ablation procedure for VT/PVCs
Evaluation of Nail Fold Microcirculation in CKD

To evaluation of nailfold microcirculation in patients with chronic renal failure and its intervention therapy

The aim of this study is to study the changes of Nailfold Microcirculation in patients with chronic renal failure, to clarify the correlation between the changes of Nailfold Microcirculation and renal function, and to explore whether nailfold microcirculation can be used as an indicator of renal microcirculation in patients with chronic renal failure, and to provide a noninvasive method for the clinical evaluation of renal microcirculation in patients with chronic renal failure.

Eligibility Criteria:
Inclusion Criteria:

* CKD patients
* Without dialysis
* Blood pressure ≤ 140/90mmHg

Exclusion Criteria:

* Polycystic kidney
* Endocrine system disease
* Cardio-cerebrovascular disease
* Rheumatic immune disease
* Peripheral vascular disease
* Hematological diseases
* Respiratory disease
* Infection
A Prospective Multicenter Study to Evaluate Usefulness of Cardio-Ankle Vascular Index in Japan

The objective of this five-year prospective observational follow-up study is to examine the additional benefits of using cardio-ankle vascular index (CAVI) as a predictive indicator of cardiovascular events in high-risk patients.


Eligibility Criteria:
Inclusion Criteria:

Patients between 40 and 74 years of age who have either of the following:

1. Type 2 diabetes mellitus
2. Metabolic syndrome
3. Grade I to III hypertension with the third layer of risk factors according to the guidelines for the management of hypertension japanese society of hypertension(JSH)2009
4. Chronic kidney disease(stage G3a or G3b) according ot the clinical Practice Guidebook for Diagnosis and Treatment of Chronic Kidney Disease 2012 in Japan
5. History of coronary artery disease or noncardiogenic cerebral infarction

Exclusion Criteria:

1. Under 40 years of age or over 74 years of age
2. An ankle-brachial index less than 0.9
3. Chronic atrial fibrillation
4. Current symptoms of heart failure(NYHA class III or IV) or left ventricular dysfunction (EF below 40%)
5. Malignancy
6. Chronic kidney disease(G4 or G5)according ot the clinical Practice Guidebook for Diagnosis and Treatment of Chronic Kidney Disease 2012 in Japan
7. chronic dialysis due to renal failure
8. Taking steroids/immunosuppressants
9. Hepatocirrhosis