cyrilzakka/clinical-trials huggingface dataset:
The Feasibility of the PAINReportIt Guided Relaxation Intervention-Outpatient

Our goal is to improve the self-management of pain and stress in adult outpatients with sickle cell disease (SCD) by determining the feasibility of a self-managed guided relaxation (GR) stress reduction intervention using a tablet-based mobile device. Currently, opioid analgesics are primarily used to treat SCD pain while self-managed behavioral modalities such as GR, are rarely used. Little is known about the effects or mechanisms of GR on pain and stress, in adults with SCD. Emerging evidence from the hypothalamic pituitary adrenal (HPA) axis theory offer insights for understanding the mechanisms. Adding GR as a supplement to analgesic therapies will address the paucity of self-management strategies for controlling pain in SCD. GR is a simple and cost-effective non-drug intervention that could reduce pain and stress in outpatients with SCD. GR is an intervention where outpatients with SCD are directed to listen to and view audio-visual recordings while they visualize themselves being immersed in that scene.

The investigator will recruit adult outpatients with sickle cell disease (SCD) from the University of Florida Health Hematology Clinics and conduct study visits in a research room located at the College of nursing.

The investigator will stratify participants on worst pain intensity (\<=5 and \>5) and randomly assign 15 adults to attention control (stress/pain tracking; 12-min SCD experience discussion) and 15 adults to experimental (stress/pain tracking; 12-min GR video clip) groups.

The immediate intervention effects will be examined for pain (primary) and stress (secondary) outcomes. Vital signs for determining relaxation responses (mediators) will be collected immediately before and after the 12-min interventions.

Eligibility Criteria:
Inclusion Criteria:

* Has SCD diagnosis;
* Reports pain 3 or greater in the previous 24 hours (0-10 scale)
* Receives care at the University of Florida (UF) Health/Shands
* Speaks and reads English
* 18 years of age or older
* Self-identifies as being of African or Hispanic descent

Exclusion Criteria:

* Legally blind
* Physically or cognitively unable to complete study measures
Awake Prone Positioning in Moderate to Severe COVID-19

The purpose of this study is comparing vital signs between standard care and prone position groups. Standard care will consist of routine clinical care, including any advice to lie in prone position as routinely recommended by participating sites. For those randomized to prone position, a special intervention team will visit patients' rooms aiming for patients to maintain the prone position for at least 8 hours a day.

This study is a pragmatic open label randomised controlled trial. After being informed about the study and potential risks, all patients having written informed consents will be randomised into two groups. Standard care group will consist of routine clinical care, including any advice to lie in prone position as routinely recommended by participating sites. To reduce bias, the study team will make visits at a similar schedule to those to patients in the intervention group, however these visits will be confined to general advice and measurement of vital signs. Patients will receive written advice more general in nature about COVID-19 disease. For those randomized to prone position group, a special intervention team will visit patients' rooms aiming for patients to maintain the prone position for at least 8 hours a day. The team will give written and verbal advice and if necessary aid patients' positioning themselves in the prone position. The exact duration of prone sessions will be determined according to ward schedules to take account of nursing procedures, meal times and mitigation strategies. Other methods to encourage the maintenance of prone position includes phone calls to patients, carers or education of carers. Compliance with the intervention will be evaluated by observation (manual and using in-room cameras) at fixed time intervals. In a subgroup of 100 patients accelerometer/gyrometer devices will be used to measure movement and position (this will be expanded to all patients if equipment is available). Other outcome measures (SpO2, heart rate etc) will be measured using standard monitoring equipment currently used at study sites, including wearable devices.

Eligibility Criteria:
Inclusion Criteria:

* Probable or confirmed COVID-19 infection according to WHO criteria
* Moderate or severe COVID-19 respiratory infection according to Vietnamese guidelines
* Requirement for supplemental oxygen therapy

Exclusion Criteria:

* Invasive mechanical ventilation, or non-invasive ventilation (NIV) with CPAP or BiPAP or imminent need for these
* Contraindications to prone position (see Appendix 5)
* Pregnancy
* Severe obesity (BMI \>35),
* Altered level of consciousness (GCS \<13)
* Attending doctor judged prone position to be unsuitable for the patient for any reason
* Patients in whom there is a decision that care will not be escalated
* Failure to have informed consent
Ventilatory Functions and Physical Intolerance in ESRD Adolescents: Response to Program of Walking With Dogs

adolescents with chronic renal failure going on hemodialysis usually complain many problems including compromised ventilation, early fatigue, early physical intolerance, and bad life quality. incentive spirometer is highly recommended to improve these problems. also, walking program, especially walking with dog, can increase the benefits of incentive spirometer

End stage renal diseased adolescents (numbering forty) will be grouped randomly to two random groups, twenty adolescents in group I or group II. Both groups will trained by incentive spirometer 30 min during the sessions of dialysis three applications weekly for 12 weeks. Group I will additionally walked freely with a dog 30 min three times weekly (in opposite days of hemodialysis). The duration of this trial will be 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* adolescents (forty) with ESRD
* patents on regular hemodiaysis

Exclusion Criteria:

* cardiac insult
* respiratory insult
* orthopedic problem
* liver insult
Phase II Study of Stereotypes and Mental Retardation: Neurobiological Basis

OBJECTIVES: I. Determine differences between persons with repetitive behavior disorders and matched controls on measures of motor control relevant to basal ganglia pathophysiology.

II. Determine the efficacy of bromocriptine, a dopamine agonist, in the treatment of stereotyped behavior and related behavior disorders.

III. Determine the efficacy of sertraline hydrochloride, a selective serotonin uptake inhibitor, in the treatment of repetitive behavior disorders.

IV. Identify behavioral, environmental, and biological variables with differential drug treatment response.

PROTOCOL OUTLINE: Motor slowness (bradykinesia) and motor control are tested in repetitive behavior disorder patients and matched controls. Group differences reflecting alterations in basal ganglia dopamine function are compared.

Behavioral assessments are conducted on each patient by trained observers. Assessments are taken at baseline and during the maintenance phase of drug treatment described below.

The efficacy of bromocriptine in the treatment of stereotypy and self-injury is determined in a randomized, double blind, placebo controlled, crossover study extending over 20 weeks. Cohorts of 6 to 8 patients first enter into a single blind placebo phase, followed by double blind treatment with placebo or bromocriptine. The crossover manipulation entails a titration phase, a maintenance phase, then a final single blind placebo condition.

The same experimental design is used to determine the efficacy of sertraline or placebo in the treatment of stereotypy and concomitant self injury and compulsions. Duration of study is 26 weeks.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Diagnosis of mental retardation
* High rate of stereotyped behavior, such as concomitant self-injurious and compulsive behaviors
* No diagnosis of tardive dyskinesia or akathisia

--Prior/Concurrent Therapy--

* No exposure to neuroleptics within 6 months prior to study

--Patient Characteristics--

* Age: 18 to 55
* Hematopoietic: (for bromocriptine and sertraline treatments) No history of anemia No clinically significant hematologic disease
* Hepatic: (for bromocriptine and sertraline treatments) No history of hepatic abnormalities No clinically significant liver disease
* Renal: (for bromocriptine and sertraline treatments) No history of renal abnormalities No clinically significant renal disease
* Cardiovascular: (for bromocriptine and sertraline treatments) No history of hypertension No clinically significant cardiac disease
* Other: No history of seizure within 4 months prior to study (for bromocriptine and sertraline treatments) No history of sensitivity to ergot alkaloids (for bromocriptine treatment) No sensitivity to serotonin uptake inhibitors (for sertraline treatment) No patients with sensory deficits (for motor function assessments)
Study of OMNI Surgical System and iStent for Eyes With OAG (Trident)

First, to compare safety and effectiveness outcomes for canaloplasty and trabeculotomy using the OMNI Surgical System to implantation of the iStent inject in lowering intraocular pressure (IOP) in pseudophakic eyes with open angle glaucoma (OAG), and second, to compare safety and effectiveness outcomes for canaloplasty alone (using the OMNI Surgical System)to implantation of the iStent Inject in lowering IOP in pseudophakic eyes with OAG.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects, 18 years or older
2. Pseudophakic
3. Diagnosis of open angle glaucoma (OAG)
4. On 1-5 ocular hypotensive medications

Exclusion Criteria:

1. Any of the following prior treatments for glaucoma:

   * Suprachoroidal stent (e.g. Cypass, iStent Supra)
   * Laser trabeculoplasty ≤ 8 weeks prior to Baseline visit with a MIGS or other glaucoma device including but not limited to iStent, iStent inject, Hydrus, CyPass
   * Trabeculectomy or other bleb forming procedure including Xen, PreserFlo, Express, glaucoma draining device/valve
   * Prior canaloplasty, goniotomy, or trabeculotomy including procedures with GATT, Kahook Dual Blade, iTrack, Trabectome
   * Ciliary ablation procedures including Endocyclophotocoagulation (ECP), Cyclophotocoagulation (G probe), Micropulse laser, or high intensity focused ultrasound (HIFU)
2. Any other form of glaucoma other than OAG
3. Concurrent ocular pathology or systemic medical condition which, in the Investigator's judgment, would either place the subject at increased risk of complications, contraindicate surgery, place the subject at risk of significant vision loss during the study period (e.g., wet AMD, corneal edema, Fuch's dystrophy, active intraocular infection or inflammation within 30 days prior to Screening Visit, etc.), or interfere with compliance to elements of the study protocol (e.g., returning to investigator's office for follow-up visits).
4. Women of childbearing potential if they are currently pregnant or intend to become pregnant during the study period; are breast-feeding; or are not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
Short-Term Effects & Safety of an Accelerated Intravenous Iron Regimen in Patients With Heart Failure

Intravenous iron replacement has been shown to benefit patients with heart failure and iron deficiency, but the weekly outpatient regimens studied to date are impractical for many patients. Our purpose is to evaluate the short-term effects and safety of an accelerated intravenous iron regimen in hospitalized patients with these two conditions.

The purpose of this pilot investigation is to evaluate the short-term hematologic effects and safety of an accelerated intravenous iron regimen in patients with heart failure and iron deficiency. Recent investigations have demonstrated improved clinical outcomes with the use of intravenous iron therapy in this patient population, but a weekly regimen administered to ambulatory patients may be inconvenient, impractical, and associated with less than optimal adherence rates for many patients, especially those with reduced functional capacity. The heart failure population is characterized by frequent hospitalizations, which would make an accelerated inpatient regimen a convenient and attractive option for improving heart failure symptoms, exercise tolerance, and quality of life. Accelerated regimens have been demonstrated as being both safe and effective in other patient populations, but no studies to date have evaluated this strategy in hospitalized patients with heart failure.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Admission to the general cardiology or heart failure services and under the care of a cardiologist at the study institution
* New York Heart Association Class II-IV heart failure
* Ejection fraction \< 40%
* Serum hemoglobin \< 12.0 g/dL
* Ferritin \< 100 ng/mL or 100-300 ng/mL with transferrin saturation (TSAT) \< 20%
* Patients deemed by an attending physician to require intravenous iron therapy based on previous attempts to correct iron deficiency or other patient-specific circumstances

Exclusion Criteria:

* Anemia of other known etiology (e.g., malignancy, malabsorption syndromes)
* Use of iron or erythropoietin-stimulating agents within previous 12 weeks
* Blood transfusion within previous 12 weeks; additionally, if patients receive blood transfusions during the study period, they will remain in the safety analysis but will be excluded from efficacy analysis
* Active bleeding
* Known infection at admission
* Immunosuppressant therapy
* Renal replacement therapy
* Known pregnancy
* Any other criteria deemed by the attending physician to warrant exclusion
Telementoring for Identifying the Appendix Using Telesonography

The investigators investigated the feasibility of the clinical application of novice-practitioner-performed/offsite-mentor-guided ultrasonography for identifying the appendix.

A randomized cross-over study was conducted using a telesonography system that can transmit the ultrasound images displayed on the ultrasound monitor(ultrasound sequence video) and images showing the practitioner's operations(background video) to a smartphone without any interruption in motion over a Long Term Evolution (LTE) network. Thirty novice practitioners were randomly assigned to two groups. The subjects in group A (n=15) performed ultrasonography for the identification of the appendix under mentoring by an onsite expert, whereas those in group B (n=15) performed the same procedure under mentoring by an offsite expert.

Each subject performed the procedure on three simulated patients. After a four-week interval, they performed the procedure again under the other type of mentoring. A total of 90 ultrasound examinations were performed in each scenario. The primary outcomes were the success rate for identifying the appendix and the time required to identify the appendix.

Eligibility Criteria:
Inclusion Criteria:

* Without any experience in ultrasonography

Exclusion Criteria:

* Subjects who do not want to participate
* Subjects who has eye pain or any eye problem
* Subjects who has wrist pain
Wearable Then Implantable Cardiac Defibrillator After Myocardial Infarction

Sudden death from ventricular arrhythmia is a serious and common complication of myocardial infarction, especially with low left ventricular ejection fraction (LVEF). Implantable cardiac defibrillator (ICD) implantation is currently recommended at three months of optimal medical treatment in patients who have had a myocardial infarction and have a LVEF below 35%. This strategy indeed allows a reduction in mortality while early post-infarction implantation showed no benefit in terms of survival. However, the risk of sudden death at this period is the greatest and the temporary defibrillator vest, marketed under the name LifeVest, is now indicated in the early post-infarction period in patients with LVEF less than 35%. Indeed, the LifeVest would allow a reduction in sudden death of rhythmic origin in the first three months post-infarction. No study has yet investigated the prognostic significance of a ventricular rhythm disorder (ventricular tachycardia \[VT\] or ventricular fibrillation \[VF\]) occurring during this early and short (approximately 3 months) particular period of wearing the LifeVest: is this a random event, or is it an event predictive of a rhythmic recurrence? The aim of the study is to assess the association between the occurrence of a sustained ventricular rhythm disorder in the early post-infarction period, during the period of wearing the LifeVest (ventricular episodes detected, treated or not), and the risk of rhythmic recurrence at 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients who benefited, between the start of 2015 and January 1, 2021, from a LifeVest after a myocardial infarction, followed by the implantation of an ICD before March 1, 2021.

Exclusion Criteria:

* Patient opposition to the use of their data.
Effects of High Intensity Interval Training and Cluster Training on Speed, Explosive Strength and Functional Performance

High-intensity interval training has been beneficial in many sports and significantly enhanced the results of physical training. Consequently, it has progressively been implemented among the football players. A Cluster Set (CS) is a set that has been broken up into smaller blocks of repeats with the inclusion of brief intra-set breaks or a reorganization of the breaks between repetitions. The initial assumption is that this design would offer a superior rise in exercise quality with the potential to maintain or enhance performance and enable larger loads, leading to stronger performance adaptations. The objective of the study is to compare the effects of high intensity interval training and cluster training on speed, explosive strength and functional performance in football players.

The objective of the study is to determine the effects of high intensity interval training and cluster training on speed, explosive strength and functional performance in football players.This is randomized clinical trial that will be conducted at football club, Pakistan sport club Lahore. Non-Probability convenient sampling technique will be used to collect data. The study will be completed in 6 months after the approval of ethical committee of RCRS \& Allied Health Sciences. Total number of participants will be 54, in group A participants will be 27, in group B participants will be 27. Performance, speed and strength will be measured by using FMS, 30-meter speed test and vertical jump test respectively. The participants will be divided into two groups. Group A will receive high intensity interval training (HIIT) and group B will receive cluster training. The training program will be conducted for 6 weeks and data will be collected pre and post training session. The data will be entered and analyzed using SPSS version 25 and Shapiro wilk test will be applied to determine the normality of the data. If data will be normally distributed then parametric type of statistical test will be applied while if the data will not normally distribute then non parametric type of test will be applied.

Eligibility Criteria:
Inclusion Criteria:

* • Male Players

  * Age between 18-30 years
  * At least 1 years of football experience

Exclusion Criteria:

* • Individuals with a lower extremity injury

  * Vestibular problems
  * Visual problems
  * Individuals who have had a concussion within the past 6 months
Improving Mental Health Among the LGBTQ+ Community

The overall aim of this program of research is to improve the mental health of people who identify as LGBTQ+ by increasing their social support through a brief intervention. The purpose of the proposed project is to establish the effectiveness of our empirically-supported, brief acceptance-based behavioral therapy (ABBT). To achieve the specific aims, the investigators will conduct a fully-powered, randomized clinical trial (n=240) with two treatment arms: treatment-as-usual (TAU) vs. ABBT.

During the COVID-19 pandemic, up to 81% of adults in the United States experienced worsening mental health. A major cause was the social isolation triggered by the pandemic due to quarantining, loss of family or friends, and loss of work. For individuals who lost social connections or were unable to adapt to maintain their connections, social support decreased and loneliness worsened, putting them at much higher risk for anxiety and depressive symptoms.

Importantly, people who identify as LGBTQ+ have been particularly affected by the social isolation caused by the pandemic and were already at much higher risk of social isolation, loneliness, and mental illness, including suicidality, before the pandemic. The objective of this R01 fully-powered trial is to examine the effectiveness of a brief acceptance-based behavioral telehealth intervention (ABBT) to improve mental health during the COVID-19 pandemic by strengthening social support among LGBTQ+ individuals.

The aims of this proposal are: (1) to examine the effectiveness of ABBT in reducing mental health morbidity by conducting a fully-powered, RCT (n=240) of ABBT vs. Treatment-as-Usual; and, (2) to examine potential mediators and moderators of ABBT treatment effects. Primary outcomes will be anxiety and depressive symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Present to recruitment clinic for any type of clinical care
* Identify as LGBTQ+
* Self-reported ≥ mild anxiety and/or depressive symptoms, based on the GAD-7 and PHQ-9
* 18 years or older
* Ability to speak and read English

Exclusion Criteria:

* None
Efficacy of Doll Therapy in the Dementia in Acute Geriatric Inpatients

Summary. Behavioral and psychological symptoms of dementia (BPSD) represents a huge emotional stress and an important burden for the patients and the caregivers severely reducing their quality of life. BPSD worsen during hospitalization and require the administration of psychotropic drugs that are often insufficient to control the symptoms, and may cause severe adverse events.

The investigators propose the use of empathy dolls in order to reduce BPSD and in particular agitation and aggressiveness in acute geriatric in-patients affected by moderate to severe forms of dementia.

The use of doll therapy in the clinical routine will allow to reduce the use of psychotropic drugs, shorten hospitalization, reduce professional and family caregiver burden improving patients' and families' quality of life.


Eligibility Criteria:
Inclusion Criteria:

* age ≥65 years
* diagnosis of dementia moderate to severe Clinical Dementia Rating scale (CDR) ≥2
* presence of agitation and/or aggressiveness
* manual and visual abilities sufficient in order to interact with the doll.

Exclusion Criteria:

* age \<65 years;
* refuse to participate;
* mild forms of dementia (CDR\<2);
* contraindication for DT as experience of mournful or traumatic events related to parental experience;
* life expectancy lower than 3 months;
* infectious diseases requiring isolation;
* negative interaction with the doll,
* presence of delirium.