cyrilzakka/clinical-trials huggingface dataset:
Storytelling Through Music to Improve Well-being Among Homeless Service Providers

Homelessness is a complex social issue and requires a dedicated workforce of helping professionals, including nurses and social workers. Secondary traumatic stress is common in this workforce and contributes to poor professional quality of life, burnout, and job turnover. These factors undermine the health and well-being of homeless service providers and threaten the stability of this critical workforce. The purpose of this study is to evaluate "Storytelling Through Music," an innovative 6-week, multi-dimensional intervention, to improve well-being among homeless service providers.

Research has found that the burden of secondary traumatic stress among homeless service providers (HSP) is similar to that among other healthcare professionals, including nurses working in urban emergency departments and in inpatient psychiatric hospitals. Left unaddressed, secondary traumatic stress can cause compassion fatigue and emotional exhaustion, furthering a cycle of poor professional quality of life (QoL), burnout, and job turnover. Research has identified that arts-based interventions have promise in helping healthcare professionals cope with work-related emotions, assist in revealing genuine emotions linked to work-related stress, and in improving professional QoL. What remains unclear is if arts-based interventions can yield similar benefits amongst HSPs.

The purpose of this study, therefore, is to evaluate the feasibility of implementing Storytelling Through Music (STM) with HSPs working with the homeless population in Austin, Texas. STM is a six-week intervention that combines storytelling, reflective writing, song-writing, and self-care skills to improve emotion regulation through affective and cognitive coping skills. Our preliminary data suggests STM to be feasible and acceptable, and preliminary evidence demonstrates improved coping, psychosocial well-being, and burnout in nurses. Specifically, this project aims to:

Aim 1: Explore the contextual factors impacting the well-being of frontline HSPs.

Aim 2: Examine the feasibility of implementing Storytelling Through Music with HSPs.

Aim 3: Investigate the preliminary intervention effect on coping (emotion regulation, self-compassion); well-being (anxiety, depressive symptoms, loneliness, post-traumatic growth, insomnia); and work-related factors (secondary traumatic stress, burnout, compassion satisfaction, and intent to leave).

Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* employed in a homeless services organization in Austin/Travis County for at least 6 months
* licensed as a nurse or social worker
* ability to read and speak English
* access to computer, internet, and zoom.

Exclusion Criteria:

* previous participation in the STM intervention
RCT Comparing Ion Levels and Clinical Outcomes of A-Class BFH to Metal on Polyethylene Total Hip Replacement

The main purpose of this prospective randomized controlled trial is to compare the concentrations of metal ions in the blood and urine of patients receiving implants that are identical except for the acetabular component: one is a monoblock and all cobalt chrome, and the other is modular with a titanium acetabular shell with a polyethylene insert.

The primary aim of this study is to demonstrate that blood ion levels (cobalt and chromium) are lower at one year in patients who receive a metal on polyethylene total hip as compared to CONSERVE® A-Class Total Hip with BFH® technology. Secondary aims include the gathering of clinical data regarding survival and dislocation rates at two years post surgery, as well as the assessment of pain, physical function, radiographic and clinical outcome at the two year interval.

Eligibility Criteria:
Inclusion Criteria:

* Individuals undergoing unilateral total hip replacement.
* Patients 50 to 70 years of age.

Exclusion Criteria:

* Patients who have previously undergone any type of joint replacement.
* Patients with evidence of active infection.
* Patients with a documented allergy to cobalt chromium molybdenum.
Tranexamic Acid Study

The purpose of this study is to determine if tranexamic acid significantly reduces blood loss and blood transfusion in revision total hip replacement. Tranexamic acid is a drug that helps to reduce blood loss during surgery. Revision total hip replacement surgery is treatment for patients who have previously had hipe replacement surgery which failed and must be repaired/replaced.

Tranexamic acid is an anti-fibrinolytic agent that inhibits fibrinolysis leading to a reduction of blood loss without concurrently increasing the risk of thromboembolic complications. Several studies have shown that tranexamic acid reduces blood loss and blood transfusions in primary total hip and knee arthroplasty. However, there have not been any studies that evaluate its efficacy in revision total hip arthroplasty. The significance of this study is that the need for blood transfusions and their complications may be minimized in revision hip arthroplasty if tranexamic acid is found to significantly decrease the amount of blood transfusions.

After the patient has been consented, he or she will be randomized into one of two groups (tranexamic acid and placebo) by the School of Pharmacy. The placebo will be crystalloid fluid of equal volume as tranexamic acid. The patient will then undergo revision total hip arthroplasty by Dr. Rosenstein and be administered tranexamic acid or placebo. Blood loss will be recorded intraoperatively and postoperatively through drains. Criteria for blood transfusion include hemoglobin less than 10g/dl or hematocrit less than 30%. Once the operation ends, the drug or placebo will be discontinued and the postoperative care is unchanged from current standards/protocols. Intraoperative blood loss, total blood loss, and number of blood transfusions will be recorded and analyzed. Length of acute hospital stay will also be recorded. A cost analysis will be performed comparing tranexamic acid to blood transfusions.

Eligibility Criteria:
Inclusion Criteria:

* Failed primary total hip arthroplasty (femoral stem, acetabular component, or both)
* 18-100 years of age

Exclusion Criteria:

* Prosthetic infection
* Primary total hip arthroplasty
* Prisoners
* Pregnancy
* Previous adverse reaction to tranexamic acid
* Bleeding/coagulation disorders
* Renal insufficiency (serum creatinine\>two standard deviations for age)
* History of deep venous thrombosis or pulmonary embolism
* Religious beliefs/practices prohibiting blood transfusions
* Wards of the state
* Cognitively impaired patients
* Terminally ill patients
* Students and/or employees
* Color blindness
Randomized Clinical Trial Comparing Conventional Laparoscopic and Robot-Assisted Laparoscopic Hysterectomy

Robotic-assisted surgery is becoming more prominent within the specialty of Gynecologic surgery with little direct evidence that it is if not better than traditional laparoscopic surgery, at least equivalent. We designed a randomized-controlled trial to compare operative times, length of hospital stay, estimated blood loss, and post-operative complications associated with these two methods of minimally invasive hysterectomy.

The proposed study will be a non-blinded randomized control trial. Patients will be randomized into each group Conventional Laparoscopic Hysterectomy (Group #1) and Robot-Assisted Laparoscopic Hysterectomy (Group #2) using a random number generator. Data collection will occur during the following points of patient interaction: pre-operative appointment, the surgical procedure, the patient's hospitalization, first post-operative appointment, and final post-operative appointment.

The care for the patients enrolled in this study will not deviate from the standard care of patients who are currently undergoing laparoscopic and robot-assisted laparoscopic hysterectomy. The patients who present to the office for pre-operative history and physical examination for laparoscopic hysterectomy will be counseled about participation in this study. Basic data collection will commence at the pre-operative visiting, including: patient demographics, past medical history, past surgical history, physical exam findings, and imaging results. The pre-operative appointment will occur between one to thirty days prior to surgery. Intra-operative and immediate post-operative data will be collected by the surgical assistant (resident or fellow) and will include surgical procedure (conventional laparoscopic or robot-assisted), operative time, hematocrit, estimated blood loss, length of stay, and complications.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing Hysterectomy
* Able to consent to the procedure

Exclusion Criteria:

1. Medical conditions not allowing for pneumoperitoneum
2. Medical conditions not allowing proper ventilation during anesthesia
3. Pelvic organ prolapse amendable to a vaginal approach
4. Pregnant women
5. Patients undergoing planned combined procedures including bowel resection (other than coincidental appendectomy) or major urologic procedures.
Extending Sleep to Reverse Metabolic Syndrome in Middle-aged Adults: Acceptability and Feasibility of a Sleep Intervention

This pilot study will test acceptability and feasibility of a sleep extension intervention in community dwelling, short sleeping, racially/ethnically diverse middle aged adults with Metabolic Syndrome (METs). Baseline sleep habits will be assessed and used to guide individualized strategies to extend sleep. A 1-group pre-test, post-test study design will test the efficacy of this 18 week study (2 weeks of baseline data collection, 1 week of study intervention planning, 12 weeks of sleep intervention planning, 12 weeks of sleep intervention delivery, final follow up 3 weeks after last day of the 12 week intervention) on sleep duration, MetS factors (waist circumference, blood pressure, fasting glucose, trigycerides, HDL-c), MetS risk behaviors (poor affective well-being, fatigue) and self regulation. Socio-ecological barriers and facilitators to the intervention will be identified using a quantitative and qualitative approach.


Eligibility Criteria:
Inclusion Criteria:

* Greater than or equal to 40 years of age and less than or equal to 60 years of age.
* Objectively confirmed MetS defined by three or more of the following:

  1. waist circumference greater than 120cm (men) or 88cm (women),
  2. blood pressure greater than or equal to 135 mmHg systolic or greater than or equal to 85 mmHg diastolic or antihypertensive medication use,
  3. fasting glucose greater than or equal to 110 mg/dL or insulin or oral hypoglycemic medication use,
  4. serum triglycerides greater than or equal to 150mg/dL or hypertriglyceridia medication use,
  5. HDL-c less than 40mg/dL (women) or less than 50 mg/dL (men) or medication use for low HDL-c1. MetS was selected because individuals with MetS are at high risk for multiple chronic conditions35.
* No obstructive sleep apnea.
* Accelerometry confirmed short sleep (average work day sleep less than or equal to 6 hours/night).
* English speaking.

Exclusion Criteria:

* Pregnancy/lactation
* Current chemotherapy treatments
* Alcohol abuse/dependence
* Night shift or shift work (previous 2 months)
* trans-meridian travel (previous 4 weeks),
* planned shift work or trans-meridian travel during intervention period
* Insomnia
* Moderate-severe or severe depression
* Sleep-promoting medications
* Habitual napping, defined as 2 naps per day or \> 90 minutes of napping on 3 or more days of the week.
Classification of Heart Failure With Preserved Ejection Fraction

The purpose of this study is to create a classification system for the heterogenous disorder of heart failure with preserved ejection fraction (HFpEF).

Patients with HFpEF are a heterogeneous group with varying etiology and pathophysiology, which may play a large role in the difficulty in managing these patients and enrolling them in clinical trials. A major advance in the care of patients with HFpEF would be a classification system based on etiology, pathophysiology, and/or genetic factors as well as machine learning analyses. The ultimate goal of this study is to demonstrate that it is possible to better classify patients with HFpEF based on etiologic, pathophysiologic, and genetic differences between patients. If successful, this study could lead to: (1) novel risk estimation in patients with HFpEF and (2) more fruitful clinical trials based on targeting specific subsets of HFpEF.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 21 years
* Signs or symptoms of congestive heart failure
* Left ventricular ejection fraction \> 50%

Exclusion Criteria:

* Severe valvular heart disease
* History of cardiac transplantation
* Prior history of heart failure associated with left ventricular ejection fraction \< 35%
Cognitive Remediation and Sheltered Employment in Schizophrenia

This study, driven on schizophrenic patients, is aimed at :

1. Measuring the efficiency of the cognitive remediation program RECOS (COgnitive REmediation in Schizophrenia) on the capacity of the patients suffering from schizophrenia to improve the integration in sheltered employment (ESAT and EA).
2. Comparing the efficiency of the program of cognitive remediation RECOS (RECOS arm) to the one of an usual program of coverage/care (TAU arm = Treatment As Usual) on integration in sheltered employment of patients suffering from schizophrenia.
3. Realizing a comparative analysis, in both arms, of :

   1. the number of working hours achieved in sheltered environment during the 6 months following the two programs (reported to the working time planned by the contract of employment)
   2. the duration of such employments in sheltered areas.
4. Estimating the impact of RECOS on the neuropsychological variables, the symptomatology, the consciousness of the disorders(insight), the quality of life and the social autonomy before the treatment (month M0), at the end of the treatment (month M3), and 6 months later (month M9), and looking for a correlation between the improvement of these parameters and sheltered employment.
5. Estimating the impact of cognitive remediation on integration in sheltered employment.


Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 50 years.
* Schizophrenia according to the criteria of the DSM-IV-TR.
* Project of entry to ESAT or to EA in the 6 weeks which follow.
* IQ \> 70 (F-NART).
* Stable symptomatology during the month preceding the inclusion.
* Psychotropic treatment unchanged during the month preceding the inclusion (change no more than 25 % posology).
* Overdrawn performances in at least one of the 6 functions estimated by the kit of neuropsychological tests.
* French mother tongue.
* Informed and signed consent by the patient.
* Agreement of the guardian (for protected adults).
* Membership in a national insurance scheme.

Exclusion Criteria:

* Dependence and recent abuses of cannabis (\> 2 / week) or in any other substance (according to the criteria of the DSM-IV-TR), except tobacco.
* Neurological disorders of vascular, infectious or neurodegenerative origin; dyschromatopsie.
* Taking of medicine with somatic tropism having a cerebral or psychic impact (eg: corticoids).
* Simultaneous participation to any other program of remediation targeting the neurocognitive deficits.
* Resistance to neuroleptic.
* Reading and writing not acquired.
Role of Midodrine and Tolvaptan in Patients With Cirrhosis With Refractory or Recurrent Ascites

The development of ascites in the natural history of cirrhosis heralds a worsening of the prognosis to 50% survival at 2 years, and this deteriorates to 30-50% at 1 year when the ascites becomes refractory to medical therapy. Hemodynamic alterations and their relation to neurohumoral systems are essential in pathophysiology of ascites formation. The theory that best explain the ascites formation and sodium retention in cirrhotics is portal hypertension leading to splanchnic arterial vasodilatation leading to underfilling of arterial circulation which is sensed by the arterial and the cardiopulmonary receptors leading to sympathetic nervous system activation and activation of the anti-natriuretic factors (RAAS and arginine vasopressin), resulting in sodium and water retention. The therapeutic options available for patients with refractory ascites are serial therapeutic paracentesis, liver transplantation and transjugular intrahepatic portosystemic shunts.Vasopressin V2 receptor antagonists antagonize the antidiuretic effects of vasopressin at the V2 receptor located in the renal collecting duct, they increase free water clearance, and thus may be helpful in mobilizing excess water in conditions associated with water retention including cirrhosis. The use of V2 receptor antagonists in cirrhosis with ascites has been shown to be safe and efficacious. Midodrine, an alpha adreno receptor agonist by causing splanchnic vasoconstriction has been used in hepatorenal syndrome (HRS) and for control of ascites in patients with refractory or recurrent ascites. It is possible that vasoconstrictors and aquaretics (V2 receptor antagonists) by acting at different sites in combination may reverse some of the pathogenic events that results in refractory or recurrent ascites.There are no reports on the use of combination of midodrine and tolvaptan in the patients with cirrhosis with ascites. Therefore, we plan to study the role of midodrine, tolvaptan and their combination on systemic hemodynamics, renal functions and control of ascites in patients with cirrhosis and refractory or recurrent ascites.


Eligibility Criteria:
Inclusion Criteria:60 consecutive patients with cirrhosis and refractory or recurrent ascites with stable renal function ( creatinine level \<1.5mg/dl for at least 7 days ).

Exclusion Criteria:

* Presence of gastrointestinal bleeding, HRS, hepatic encephalopathy of grade 2 or higher or infection within 1 month preceding the study or during the study, presence of diabetes, intrinsic renal or cardiovascular disease or arterial hypertension on history and physical examination, abnormal urine analysis, chest radiograph or electrocardiogram, presence of hepatocellular carcinoma or portal vein thrombosis or treatment with drugs with known effects on systemic and renal hemodynamics within 7 days of inclusion .
Effects of Shockwave Therapy on Crouched Gait Due to Hamstring Flexibility in Cerebral Palsy Children

Randomized controlled trial will be conducted on thirty-two cerebral palsy children in Punjab Special School. Spastic Diplegic CP children with GMFCs level III, IV, V with age range of 6 to 12. These children have limited range of hamstring muscles. Assessment will be measured Pre and Post treatment by goniometer of crouched gait in standing and lying on couch. Crouched gait will be measured by Knee flexion in standing and lying. To measure hamstring flexibility ROM of knee extension is measured with 90 flexion at hip joint. Spasticity in this study will be assessed by GMFM-88 and modified Ashworth scale.

Shortwave therapy, stretching and orthotics will be provided to Group A. Shock wave session will be provided for 20 minutes thrice a week. Five days, five minutes with 30 seconds sustained stretch will be provided and than orthotics will be used to obtained the sustained effect.

In Group B spastic diplegic children just given stretching with strengthening and orthotics. We provide sustained 30 seconds stretch with 30 seconds rest for 5 minutes and followed with forty repetition of hip flexor and knee flexors and range will be maintained by applying orthosis.

Eligibility Criteria:
Inclusion Criteria:

* Children with GMFCS level I, II \& III.
* Passive range of motion of knee extension is limited to 20 degree with hip 90 degree.
* Age between 6 to 12 years.

Exclusion Criteria:

* Children with epileptic history
* Previous muscular lengthening technique applied
* Previous history of botox injection used.
Retrobulbar Triamcinolone Acetonide Injection in the Treatment of NA-AION

NAION produces an ischemic insult in the optic nerve head presumably due to the hypoperfusion of the short ciliary arteries that supply it.

Intravenous injection of glucocorticoid have proven to be effective in treatment of Nonarteritic Anterior Ischemic Optic Neuropathy,but have some side effects. the investigators believe that offering them Retrobulbar Triamcinolone Acetonide Injection that might halt the progression of the visual acuity and visual field loss if our hypothesis is correct, would greatly improve their chances of avoiding blindness.


Eligibility Criteria:
Inclusion Criteria:

Sudden mono ocular vision loss associated with optic disc edema and positive Marcus Gunn (\<30 days)

Exclusion Criteria:

Any eye disease except NAION(Nonarteritic Anterior Ischemic Optic Neuropathy) Neurologic defect Abnormal ESR, CRP, any history of retina or vitreal surgery Severe corneal opacity which makes retina examination impossible
Influence of Different Physical Therapy Resources Application After Reduction Stomach Surgery

The aim of this study will be to investigate the effects of using physical therapy resources in the postoperative morbidly obese individuals undergoing gastroplasty.

It is believed that the application of these various features of physiotherapy after abdominal surgery may contribute differently in restoring lung function and prevention of pulmonary complications and can thus identify the resources that can contribute more effectively in post-operative bariatric surgery.

The aim of this study will be to investigate the effects of using physical therapy resources in the postoperative morbidly obese individuals undergoing Roux-en-Y gastric by-pass with regard to: lung volumes and capacities, prevalence of atelectasis, thoracoabdominal mobility and evaluation of peak flow of cough, evaluated pre and post operative.

Individuals with BMI between 40 and 55 Kg/m², aged between 25 and 55 years, underwent the surgical procedure Roux-en-Y type gastric by-pass by laparotomy and normal preoperative pulmonary function will be included.

The volunteers will be divided into seven different groups, according to the treatment received during hospitalization after surgery:

G control: subjects treated with conventional physiotherapy according to the routine service of physiotherapy of the hospital; G Voldyne: subjects treated with incentive spirometry, Voldyne Model 5000® (Sherwood Medical, USA); G CPAP: subjects treated with "continuous positive airway pressure"; G EPAP: subjects treated with "expiratory positive airway pressure"; G IPPB: subjects treated with "intermittent positive pressure breathing"; G BIPAP: subjects treated with "bi-level positive airway pressure"; G BS: subjects treated with "breath stacking" (siliconized mask connected to a unidirectional valve allowing only inspiration).

The application of resources will be held twice a day in the immediate and in the first postoperative sessions in 6 sets of 15 reps or 30 continuous minutes, with an interval of 4 hours between sessions. The researcher will remain alongside the volunteers, following them and monitoring vital signs and respiratory comfort.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 40 and 55 Kg/m²
* Aged between 25 and 55 years
* Submitted to Roux-en-Y type gastric by-pass by laparotomy
* Normal preoperative pulmonary function test

Exclusion Criteria:

* Hemodynamic instability
* Hospital stay longer than three days
* Presence of postoperative complications
* Smoking