cyrilzakka/clinical-trials huggingface dataset:
Circle Dance for Family Caregivers of the Elderly With Alzheimer.

The primary objective of this research is to compare the effects of a 12-week CircleCare on physical functioning of family caregivers of the elderly with AD. Effects on cognition, psychosocial and frailty-related aspects (secondary objective). The acute effect of one circle dance session on mood states (tertiary objective). This randomized controlled trial will involve 40 family caregivers over 50 years old allocated into a control group or an intervention group of 12-weeks (twice a week, 60 min per session) of CircleCare. Primary outcomes will include balance, speed of gait, lower limb muscle strength, functional mobility and risk of falls. Secondary outcomes will include cognition, burden, stress, depression, quality of life and frailty. Mood states will be a tertiary outcome. The effects of CircleCare will be verified with an ANOVA two-way test and a multiple comparison test when necessary. The analyzes will follow an intention-to-treat approach. The change in moods will be evaluated by the paired t-test. The level of significance will be set at p\<0.05. This study may guide professionals and health policymakers in deciding whether to implement this type of intervention. If positive effects are demonstrated, this program can be offered in public health services to other groups, given its low cost.


Eligibility Criteria:
Inclusion Criteria:

* 50 years or older.
* Family caregiver for at least 6 months of an elderly person with Alzheimer's disease.
* Ability to walk without the help of another person.

Exclusion Criteria:

* Cardiopulmonary or orthopaedic contraindication to the practice of physical exercise.
* Severe visual or hearing deficiency that impedes participation in the intervention and assessments.
Treatment of Diabetes in Patients With Systolic Heart Failure

Investigator Initiated Study to study the effects of Canagliflozin 100 milligrams (mg) vs Sitagliptin 100 mg on parameters of aerobic exercise capacity (peak oxygen consumption \[VO2\]) and ventilator efficiency (minute ventilation \[VE\]/carbon dioxide production \[VCO2\] slope) at cardiopulmonary exercise test (CPET) after 12 weeks of active treatment (primary endpoints). Blood pressure (BP), body water content, body composition, cardiac function, and diet will be also measured (secondary endpoints).

Investigator Initiated Study: Randomized, double-blinded, active-control clinical trial to determine the safety and efficacy of Canagliflozin and Sitagliptin in patients with type 2 diabetes and systolic heart failure (HF).

The investigators propose to study the effects of Canagliflozin 100 mg vs Sitagliptin 100 mg (both administered once daily for 12 weeks) on parameters of aerobic exercise capacity and ventilator efficiency by CPET after 12 weeks of active treatment. BP, body water content (Bioelectrical Impedance Analysis \[BIA\]), body composition (Dual-energy X-ray absorptiometry \[DEXA\]), cardiac function, diet and biomarkers will be also measured. Subjects with evidence of left ventricular hypertrophy will undergo cardiac magnetic resonance (CMR) imaging.

Eligibility Criteria:
Major Inclusion Criteria:

* Symptomatic stable heart failure (New York Heart Association (NYHA) functional classification II-III) with reduced left ventricular ejection fraction (LVEF) ≤40%
* Peak exercise limited by shortness of breath and associated with a respiratory exchange ratio (RER) \>1.00 (reflecting maximal aerobic effort);
* Poorly controlled Type 2 Diabetes Mellitus (T2DM)(HbA1c levels between 7.0% and 10.0% if on a treatment regimen including insulin, or between 6.5% and 10.0% if not on an insulin regimen);
* Eighteen years of age or older.

Major Exclusion Criteria:

* Type I diabetes;
* Open label treatment with Sodium-GLucose coTransporter (SGLT)-2 inhibitors (within the past 3 months);
* Current treatment with thiazolidinedione (within the past 3 months);
* Chronic Renal Disease defined as Glomerular Filtration Rate (GFR) \<50 ml•min-1/1.73m2 according to local laboratory
* Pregnancy or of child-bearing potential or lactating;
* Active or recent (within 2 weeks) genital/urinary infection;
* Concomitant conditions or treatment which would affect completion or interpretation of the study (i.e, physical inability to walk or run on a treadmill
* Inability to give informed consent.

Exclusion criteria specific to the cardiac magnetic resonance (CMR) substudy.

* Estimated GFR \<60 ml•min-1/1.73m2
* Implantable cardioverter defibrillator, pacemaker or other implantable metal device not compatible with CMR scanning;
* Severe claustrophobia, inability to lay flat for up to 60 minutes, or other contraindication to CMR scanning.
Post Discharge Circadian Rhythms Post Adenotonsillectomy

The purpose of this study is to utilize non-invasive, easily measurable biomarkers (heart rate, skin temperature, sleep, and activity) in the post surgical discharge period to identify trends which correlate with improved outcome and early recovery (return to baseline activity). These are measured (captured) utilizing a wearable technology (WT) device.

Return to baseline (RTB) activity for the purpose of this study is defined primarily as step count normalization as a surrogate of activity (pre versus post operative step count), and heart rate variability normalization back to preoperative baseline. Increased heart rate variability has been studied in acute care settings as a marker of poor prognosis. Please note that return to baseline is not defined for the pediatric population in the same way as adults (which is primarily questionnaire based and not applicable in children).

Wearable technology has tremendous advantages over current methods of assessing RTB activity in the post-discharge pediatric population after AT, which rely on quality of life (QOL) scales, caregiver and patient reports, as well as nurse phone calls and office visits. These methods are biased, time and labor intensive, disease focused, and caregiver dependent. The investigators propose to use wearable technology in order to assess RTB activity. The device has validated methodology in sleep metrics (as compared to polysomnography), heart rate and activity monitoring (optical sensor and 3 plane accelerometry), and temperature measuring (galvanic skin resistance). So far, no investigators have utilized wearable technology and biomarker (heart rate, skin temperature, activity, sleep) data in the manner proposed. RTB is a difficult to measure entity in children and the investigators have defined it using step count as a marker of activity. There are no studies or "standard" to measure quality of recovery in children.

Eligibility Criteria:
Inclusion Criteria:

* As stated previously, OSA v. non OSA

Exclusion Criteria:

-
Nursing Narratives, Reflective Practice and Professional Development (NarratUN)

Background: In addition to foster reflective practice, clinical narratives may be used as a means to improve nurses' critical thinking and their acquisition of clinical competencies. However, few studies have studied their potential value to promote nursing professional development and there is no evidence that shows their value as a tool to improve nurses' competencies to provide a person-centred nursing care.

Purpose: To evaluate the preliminary efficacy of narratives for the development of three nursing professional competences -respect, intentional presence and knowing the person- paramount to provide person-centred care.

Method: A pilot quasi-experimental study. A total of 34 nurses enrolled in a global training course of a nursing specialization were recruited in September 2016. All the nurses received a multi-component intervention based on the Critical Reflexive Inquiry Model. The strategies of this program consisted in the writing of 3 narratives; 3 masterclass of 3, 2 and 3 hours respectively; a discussion group; and a face-to-face interview. The NarratUN Evaluation tool was used to assess outcomes. The primary outcome was the difference in the mean of respect, intentional presence and knowing the person pre and post intervention. Changes within nurses were analyzed using Wilcoxon signed Rank test.


Eligibility Criteria:
Inclusion Criteria:

* Being in a specialized training programme

Exclusion Criteria:

* Not being in a specialized training programme
A Safety and Efficacy Study of Intravenous E5564 in Patients With Severe Sepsis

Sepsis is a serious condition where there is inflammation and damage to body tissue, usually caused by an infection. This infection can lead to decreased function of vital body organs and in some cases may lead to permanent health problems or death.

Much of the injury is due to endotoxin, a harmful substance produced by certain types of bacteria. An endotoxin antagonist is designed to block the effects of endotoxin.

This study is designed to study the safety and efficacy when treating patients with severe sepsis.


Eligibility Criteria:
Inclusion Criteria:

* Presently admitted, or about to be transferred, to the ICU.
* Women of Child-bearing potential must have a negative serum (or urine) hCG assay within 24 hours prior to drug administration.
* Any Race.
* Severe Sepsis \[newly developed respiratory failure, refractory shock, renal dysfunction, hepatic dysfunction, or metabolic acidosis and at least three signs of SIRS (systematic inflammatory response syndrome)\].
* Objective signs of infection likely to be caused by a bacterial or fungal pathogen.
* Patients must receive study medication within 8 to 12 hours of recognition of the initial sepsis-related organ failure.
* APACHE Predicted risk of mortality score between 20% and 80%.
* An intent by physicians and family to aggressively treat the patient for the 28 day study period.

Exclusion Criteria:

* Cardiogenic or hypovolemic shock.
* Acute third degree burns involving \>20% of body surface.
* Recipients of non-autologous organ transplants within the past year.
* Pregnancy.
* Chronic vegetative state.
* Uncontrolled serious hemorrhage (.2 units of blood/platelets in the previous 24 hours). Patients may be considered for enrollment if bleeding has stopped and patients are still otherwise qualified.
* Unwilling or unable to be fully evaluated for all follow-up visits.
* Patients who are classified as "Do not resusitate" or "Do not treat."
* Patients who develop severe sepsis \<36 hours post trauma or post-surgery. Patients may be considered for enrollment \>36 hours post-trauma or post-surgery, if they meet other inclusion criteria.
* Patients with a predicted risk of mortality score of \<20% or \>80% after recognition of qualifying organ failure.
* Patients with a predicted risk of mortality of \<51% for whom Xigris® use is planned.
Studying Genes in Samples From Younger Patients With Adrenocortical Tumor

RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research trial studies genes in samples from younger patients with adrenocortical tumor.

OBJECTIVES:

* To perform whole-genome sequencing, deep sequencing, micro RNA analysis, methylation status, copy number variation analysis, and single-nucleotide polymorphisms (SNPs) analysis in pediatric adrenocortical tumors and compare those results to those of the same patient's normal cells.

OUTLINE: Archived tumor and blood samples are analyzed for whole-genome sequencing, deep sequencing, micro RNA , methylation status, copy variation, and single-nucleotide polymorphisms. Results are then compared with patients' normal cells.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Banked tumor and blood samples obtained from patients enrolled on COG-ARAR0332 in North America and Brazil

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Effects of Probiotics and/or Prebiotics on the Duration of Diarrhea and Hospitalization in Children

* Acute diarrhea continues to be a major cause of childhood morbidity and mortality in developed and developing countries.
* Prevention and treatment of dehydration are the mainstays of therapy. Rehydration can be achieved with oral rehydratation solution (ORS).
* Even though ORS has reduced the mortality and morbidity very significantly, it has no effect on the duration of diarrhea, stool consistency and frequency and remains underused.
* ESPGHAN and ESPID published together an evidence based guideline and stated that in the management of acute gastroenteritis rehydration is the key treatment and that selected probiotics may reduce the duration and intensity of symptoms and can be used as an adjuvant to ORS.
* Current evidence also indicates that probiotic effects are strain-specific. Lactobacillus GG and Saccharomyces boulardii are the best studied strains. However, more research is needed to guide the use of particular probiotic regimens and strains and as there is still no evidence of efficacy for many preparations.

Acute diarrhea continues to be a major cause of childhood morbidity and mortality in developed and developing countries. Prevention and treatment of dehydration are the mainstays of therapy. Rehydration can be achieved with oral rehydratation solution (ORS). Even though ORS has reduced the mortality and morbidity very significantly, it has no effect on the duration of diarrhea, stool consistency and frequency and remains underused. ESPGHAN and ESPID published together an evidence based guideline and stated that in the management of acute gastroenteritis rehydration is the key treatment and that selected probiotics may reduce the duration and intensity of symptoms and can be used as an adjuvant to ORS. A recent Cochrane review including 56 trials in children concluded that speciﬁc probiotics reduce the duration of diarrhea with about 24 hours and decrease the frequency of defecation on the second day. Current evidence also indicates that probiotic effects are strain-specific. Lactobacillus LGG and Saccharomyces boulardii are the best studied strains. However, more research is needed to guide the use of particular probiotic regimens and strains and as there is still no evidence of efficacy for many preparations. The aim of this study was to evaluate effects of different probiotics on the duration of acute infectious diarrhea.

Eligibility Criteria:
Inclusion Criteria:

* children of both sexes aged between 3 and 60 months, with acute watery diarrhea lasting more than 12 hours but less than 72 hours, requiring hospitalization. Children with clinical signs of mild to moderate dehydration (prolonged capillary refill time, abnormal skin turgor and 3-9% percentage loss of body weight).

Exclusion Criteria:

* clinical features of hypovolemic shock and/or necessitating admission at the intensive care unit were excluded. Other exclusion criteria were use of antibiotics or probiotics 1 month before admission, severe malnutrition and chronic underlying disease including immunocompromised conditions
Transcranial Magnetic Stimulation in Children With Attention Deficit Hyperactivity Disorder (ADHD). A Safety Study

Low frequency repetitive Transcranial Magnetic Stimulation(rTMS) is a safe and tolerable procedure in children with Attention Deficit Hyperactivity Disorder(ADHD); it also could be a complement to the treatment of patients with poor symptomatic control to conventional treatment.

Attention Deficit Hyperactivity Disorder is a common disorder in the infancy; the majority of ADHD have good clinical response to amphetamines alone or in association with antiepileptic drugs. It is described that some patients(10-30%) with ADHD do not respond to conventional pharmacological and psycho- pedagogical treatment; in those patients non invasive brain stimulation methods could be a supplementary option for symptomatic control. There are not many published papers describing the effects of rTMS in persons younger than 18 years; so the first step to extent its use in pediatric population should be to obtain evidences about its tolerance and safety.

Eligibility Criteria:
Inclusion Criteria:

* Ages eligible for Study: 7years to 12 years
* Genders Eligible for Study: Both

Exclusion Criteria:

* History of convulsions
* Co-morbidity with other psychiatric or neurologic disease
Guided Bone Regeneration in Atrophic Anterior Maxillary Ridges

This study is aiming to evaluate clinically, radiographically ,and histologically GBR using collagen membrane in combination with a mixture of ABBM and autogenous particulated bone compared to collagen membrane with ABBM in atrophied anterior maxilla.

Guided bone regeneration (GBR) has been proposed as a possible alternative for patients with severe horizontal bone atrophy, to overcome the drawback of bone blocks techniques.6,8 To protect and prevent the invasion of the clot by nonosteogenic cells, maintaining an adequate biological space for the regeneration of bone tissue, the use of resorbable membranes, in combination with autologous or heterologous particulate bone have been proposed. Expanded polytetrafluoroethylene (e-PTFE) membranes are the most used non-resorbable membranes with the longest published follow-up, considering them the gold standard in the reconstructions of major horizontal bone defects. However, a second surgery is needed to remove them and they may get exposed in the oral cavity and contaminate with possible infection and graft loss. Conversely, the resorbable membranes most advantages are an ability to merge with the host tissues, as well as a rapid resorption in case of exposure, thereby reducing the risk of bacterial contamination. Resorbable membranes in combination with particulated anorganic bovine bone (ABB) can be used for the augmentation of horizontally deficient ridges. Particulated autogenous bone can be mixed with bone substitutes to add more osteogenic factors.

Eligibility Criteria:
Inclusion Criteria:

* Patients with atrophied anterior maxillary ridge area.
* Age: 18 years and older.
* Both sexes.
* No intraoral soft and hard tissue pathology.
* No systemic condition that contraindicate bone augmentation

Exclusion Criteria:

* • Heavy smokers more than 20 cigarettes per day.(32)

  * Patients with systemic disease that may affect normal healing.
  * Psychiatric problems.
  * Disorders to bone augmentation are related to history of radiation therapy to the head and neck neoplasia.
  * Pregnant or nursing women.
  * Patients with uncontrolled diabetes mellitus, rheumatoid arthritis or osteoporosis.
  * Patient with previous history of radiotherapy.
Student Pharmacist Non-Pharmacological Intervention on Type 2 Diabetes Management in Older Asian Adult Populations

This study is being done to assess the impact of student pharmacist involvement on blood glucose control through non-pharmacological interventions in people of Asian and Asian descent over the age of 50 with type 2 diabetes. This study team is trying to advance the field of pharmacy and expand the roles of student pharmacists.

This study aims to assess the clinical impact of student pharmacist-led interventions on glycemic control in adult populations. This study will specifically target adults aged 50 years and older of Asian or Asian-descent with diagnosed type 2 diabetes, residing in San Francisco. The goal of the study is to demonstrate the utility of pharmacy students in a community setting on chronic disease management through patient-specific education and interventions. The aims of this study are to compare glycemic control in patients with type 2 diabetes who receive continuous assessment and non-pharmacological counseling from student pharmacists versus those who do not. Specifically, this study will evaluate:

1. The impact of student pharmacist assessments and personalized recommendations on diet, exercise, and adherence to treatment regimens, and their lasting effects on blood glucose control.
2. If participants perceived any value and effect of student pharmacist involvement in managing chronic diseases.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 50 years old
* Asian or Asian-descent
* Diagnosed with T2DM
* A1C \>7.0% (uncontrolled)
* Take blood glucose measurements as prescribed by their physician, or consistently (defined as missing no more than 1 reading from their regular routine).

Exclusion Criteria:

* Age \< 50 years old
* Not diagnosed with type 2 diabetes, or have diagnoses such as type 1 diabetes, gestational diabetes, or medication induced diabetes
* Patients that are on medications that affect glycemic control
* Corticosteroids
* First-generation antipsychotics (e.g. chlorpromazine, perphenazine, phenothiazines)
* Immunosuppressants (e.g. tacrolimus, cyclosporine)
* Experiencing acute disease states
* Recent surgery/hospitalized within the last 3 months
* Active infections
* Non-adherence to blood glucose monitoring (defined as missing \> 1 reading from their regular routine or not taking readings as prescribed by their doctor)
* Patients with late stage T2DM requiring insulin therapy
* Diagnosed with cancer, end-stage renal disease, end-stage liver disease
* Received any organ transplant
Inter-rater Reliability of the Australian Spasticity Assessment Scale (ASAS) in Post-stroke Spasticity

The reliability of the Australian Spasticity Assessment Scale (ASAS) has been reported to be not high enough in adult patients with acquired brain damage. The low number of patients and the heterogeneous study population have been reported as important limitations in the reliability study of this measure. Therefore, the reliability of the ASAS needs to be confirmed in stroke patients with spasticity. This study aims to investigate the inter-rater reliability of the ASAS in a study population consisting of a larger and more homogeneous patient population (those with post-stroke spasticity).

Spasticity is a motor disorder characterized by a velocity-dependent increase in tonic stretch reflex due to upper motor neuron lesion. The prevalence of post-stroke spasticity is between 17-40%. In the assessment of spasticity, although biomechanical and neurophysiological methods provide quantitative data, semi-quantitative methods are mostly used clinically. The most frequently used spasticity measures are the Modified Ashworth Scale and the Modified Tardieu Scale. However, these methods have significant disadvantages. Therefore, the search for more reliable clinical measures continues. One of the newly developed clinical scales is called the Australian Spasticity Assessment Scale (ASAS). Although ASAS has been reported to have a high level of reliability in children with cerebral palsy, the same has not been detected in adult patients with acquired brain damage. The low number of patients and the heterogeneous study population have been reported as two of the important limitations in the reliability study of this measure.

In this study, researchers aim to investigate the inter-rater reliability of the ASAS in a study population consisting of a larger and more homogeneous patient population (those with post-stroke spasticity).

Eligibility Criteria:
Inclusion Criteria:

* Chronic stroke (\> 6 months)
* Fist stroke
* Increased tone according to the Modified Ashworth Scale in at least one of the elbow, wrist, and ankle
* Stability of spasticity for the last 3 months

Exclusion Criteria:

* Increased tone due to causes other than stroke (traumatic brain injury, spinal cord injury, multiple sclerosis, motor neuron disease, etc.)
* Acute or subacute stroke (≤6 months)
* Recurrent stroke attacks
* Presence of contracture and/or moderate to severe pain in the joints to be assessed (elbow, wrist, and ankle)
* Botulinum toxin injection in the last three months
* History of neurolysis for spasticity (alcohol or phenol)
* History of surgery for spasticity
* Initiation of a new drug for spasticity, or a change in drug dose