cyrilzakka/clinical-trials huggingface dataset:
Non-pharmacological Treatments for Non-malignant and Malignant Pain

Chronic pain concerns one in four adults in Belgium. Because of the psychological and social repercussions, a biopsychosocial approach is necessary in order to improve the quality of life of people suffering from chronic pain. Non-pharmacological techniques such as hypnosis, self-care learning and music-therapy are gaining more and more interest in the scientific field. Indeed, several studies have shown a reduction in psychological distress and an improvement in global quality of life after having learned self-hypnosis/self-care. Furthermore, other studies focusing on music as a treatment for chronic pain highlight an analgesic effect of music over pain and a reduction of common comorbidities. Nevertheless, only few studies aim at comparing these techniques to each other. The aim of our study would be to compare a 7 months learning program of self-hypnosis/self-care, music-therapy/self-care, motivation to learn self-hypnosis/self-care in order to highlight the most efficient treatment for chronic pain. Furthermore, we will include another type of chronic pain i.e. cancer pain to understand if self-hypnosis/self-care's impact is different in the other type of chronic pain.


Eligibility Criteria:
Inclusion Criteria:

* Major
* Fluency in French
* Chronic pain diagnosis (malignant and non-malignant)

Exclusion Criteria:

* Neurologic disorder
* Psychiatric disorder
* Drug addiction
* Alcoholism
Neurally Adjusted Ventilatory Assist for Weaning From Invasive Mechanical Ventilation in Critically Ill Children

The goal of this clinical trial is to compare weaning from mechanical ventilation in critically ill children. The main questions it aims to answer are:

* Will weaning with neurally adjusted ventilatory assist (NAVA) mode ventilation result in shorter ventilator day than synchronised intermittent mandatory ventilation (SIMV) mode?
* Will weaning with NAVA mode ventilation result in shorter paediatric intensive care unit (PICU) length of stay than SIMV mode? Participants will be randomised to NAVA or SIMV group for weaning from mechanical ventilation, then PICU outcomes from both groups will be collected, analysed and compared.


Eligibility Criteria:
Inclusion Criteria:

* all critically ill children admitted to PICU

Exclusion Criteria:

* failure to obtain informed consent
Study Comparing Tutomesh® Repair to Conventional Surgical Techniques in Potentially Contaminated Hernia Repair and Abdominal Wall Reconstruction

This is a multicentric prospective randomized study comparing technique of tension-free repair with placement of a bovine pericardium bioprosthesis (Tutopatch® and Tutomesh®) to current conventional surgical techniques in potentially contaminated hernia repair and abdominal wall reconstruction.

The hypothesis is that using Tutomesh® prostheses reduces the risk of postoperative complications at 30 days in the treatment of incisional hernias or complicated abdominal wall hernias (ref early complications) for potentially contaminated fields.


Eligibility Criteria:
Inclusion Criteria:

* Patient presenting with an incisional hernia or complicated hernia contraindicating the use of non absorbable mesh:

  * Infected incisional hernia: abdominal wall abscess, chronic fistula
  * Incisional hernia with high septic potential: incisional hernia with strangulation of one or more intestinal loops, repair of incisional hernia during surgery requiring opening of the digestive tube (digestive resection, restoration of digestive continuity, gastro-intestinal perforation, peritonitis from digestive origin)
  * Recurrent incisional hernia with problem of cutaneous healing
  * Incisional hernia requiring important intestinal adhesiolysis
* Patients signing informed consent form after reading and understanding the information letter _ Patients are more than 18 year old

Exclusion Criteria:

* Patient with major anesthetic risk (ASA 4)
* Patient suffering from immunodepression or under immunosuppressor treatment (corticoids...)
* Patients already enrolled in another study
* Patient suffering from severe disease not allowing a 1-year follow-up
* Patient refusing to be enrolled after consulting the information letter
* Patient presenting with a too large incisional hernia, superior to 140x200 mm
* Pregnancy
Exercise Regulation of Human Adipose Tissue

The purpose of this study is to determine whether exercise training leads to changes in the white adipose tissue that are beneficial to the body's regulation of sugar and body weight.

The prevalence of obesity and type 2 diabetes in the United States and worldwide has risen dramatically over the last few decades, resulting in an enormous need for new therapies to treat these conditions. The discovery that beiging of subcutaneous white adipose tissue may increase energy expenditure has led to tremendous interest in beige cells as a potential treatment for diabetes and obesity. An established treatment for type 2 diabetes and obesity is endurance exercise training. Exercise training can improve systemic homeostasis, and although adaptations to skeletal muscle play a critical role in these effects, the underlying mechanisms are not fully understood. Moreover, the contributions of other tissues in these beneficial effects of exercise on metabolism have not been intensively investigated. The study team hypothesizes that exercise training results in fundamental changes to white adipose tissue, including beiging, and these adaptations play an important role in the effects of exercise training to improve metabolic homeostasis.

Eligibility Criteria:
Inclusion Criteria:

* Age: 25-55 years old at the time of screening
* Body mass index (BMI) must be:

  * ≥20 and ≤ 27 kg/m2 for lean subjects
  * ≥25 and ≤ 37 kg/m2 for subjects with type 2 diabetes
  * ≥27 and ≤ 37 kg/m2 for obese/overweight subjects
* HbA1c values:

  * ≤5.7 ± 0.1% for lean and overweight/obese subjects
  * 6.5 ± 0.1% - 9.0 ± 0.1% for subjects with type 2 diabetes

Exclusion Criteria:

* Age \<25 and \>55 years old
* Type 1 Diabetes
* HbA1c ≥ 9.0%
* Heart or lung disease
* Basal-Bolus Insulin regimen
* Use of beta-blockers or thiazolidinediones
* Acute systemic infection accompanied by fever, body aches, or swollen lymph glands
* BMI ≥ 37 kg/m2
* Current dieting or weight loss efforts
* Current pregnant or breastfeeding
* Known history of HIV/AIDS or certain cancers
* Biochemical evidence of renal or hepatic dysfunction; renal or liver disease
* Demyelinating diseases such as multiple sclerosis or amyotrophic lateral sclerosis
* Recent blood donation
* Clinical history of stroke
* Severe hypertension (systolic \> 160 mmHg or diastolic \> 90 mmHg)
* Inability to exercise at 50% of predicted heart rate (HR) reserve at baseline
* Participants who screen positive for The American Heart Association's contraindications to exercise testing
* History of keloid formation
Therapeutic Horsemanship in Veterans

The project partnered with U.S. military veterans with a premier accredited therapeutic riding center for six weeks. The veterans interacted with horses by grooming and learning about them, as well as riding them for one hour per week during which they gained a variety of skills. We hoped the veterans would experience a reduction in Post Traumatic Stress Disorder (PTSD) symptoms, depression, and loneliness, while improving their social and emotional health and self-efficacy.

Large numbers of post-deployed U.S. veterans diagnosed with Post Traumatic Stress Disorder (PTSD) and/or Traumatic Brain Injury make effective interventions urgent, to reduce symptoms and increase veterans' coping. PTSD includes anxiety, flashbacks, and emotional numbing. Symptoms expand health care costs for stress-related illnesses making veterans' civilian life difficult.

The proposed study used a randomized experimental design with repeated measures and waitlist control group testing the efficacy of a 6-week human-horse interaction and systematic therapeutic horseback riding program in: decreasing PTSD symptoms, increasing coping self efficacy, emotion regulation, and social engagement. The Riding Group spent one hour weekly interacting with and riding the same horse at one of two PATH-accredited riding centers in Mid-Missouri supervised by an Occupational Therapist, Profession Association of Therapeutic Horsemanship (PATH) International-certified instructor, leader and side walkers as needed. Riding was directed by a systematic lesson plan. Data collection occured at baseline, 3 weeks, and 6 weeks. The Control Group was assessed at the same intervals and again 3 weeks and 6 weeks after joining the Riding Group.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Veterans, left active military service (not serving in reserve units.)
* Diagnosed with Post Traumatic Stress Disorder/Traumatic Brain Injury or both according to ICD-9 diagnostic codes.
* Weight less than 220 pounds.
* Able to walk at least 25 feet without the assistance of a person (but potentially with assistive devices).
* Willing to interact with and ride a horse.
* Have not ridden a horse in the past year.
* Care Provider assent

Exclusion Criteria:

* Age less than 18 years
* Veterans in active military service (including reserve units).
* No diagnosis of PTSD/TBI or both according to ICD-9 diagnostic codes.
* Weight greater than 221 pounds.
* Unable to walk at least 25 feet without the assistance of a person (but potentially with assistive devices.)
* Unwilling to interact with and ride a horse.
* Have been riding a horse in the past year.
* Care Provider unwilling to provide assent
Robotic vs. Conventional Minimal-invasive Inguinal Hernia Repair

Minimal invasive techniques have become a well established approach for inguinal hernia repair over the last decade in developed countries. Different techniques such as total extraperitoneal endoscopic hernioplasty (TEP) and transabdominal preperitoneal hernia repair (TAPP) have been described. These studies show comparable results in short and long term outcome. Robotic inguinal hernia surgery enables an even more precise dissection within the preperitoneal layer thus preserving the nerves of the lateral abdominal wall. This may translate into a reduced level of acute and chronic postoperative pain as previously reported by retrospective case series. The role of robotic surgery for inguinal hernia repair in regard of postoperative pain and recovery has not been investigated in randomized and blinded clinical studies yet. With this randomized and blinded trial the investigators compare robotic TAPP (rTAPP) to conventional TEP with a decreased pain level shortly after surgery as primary outcome (numeric rating scale - NRS). A reduced postoperative NRS for pain may translate into faster recovery and less chronic pain, secondary endpoints include comparison of pain in a longer course (short-form inguinal pain questionnaire (sf-IPQ)), quality of life / health status (Baseline Short Form-12 (SF-12), Carolinas Comfort Scale (CCS)), complications (Comprehensive Complication Index - CCI), rate of recurrence, , economic impact in terms of costs of surgery per patient, for the institution, the sick leave and the cost-effectiveness of health intervention (SF-6D, EQ-5D, ICECAP-O). Also included are ergonomics for the surgeon (NASA TLX).


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years of age and able to understand and give their informed consent for the study.
* Primary unilateral or bilateral hernia

Exclusion Criteria:

* Recurrent hernia
* with previous open abdominal surgery at or below the umbilicus
* need of an open inguinal hernia repair (patient's preference, unable to undergo general anesthesia, unable to tolerate pneumoperitoneum)
* liver disease defined by the presence of ascites
* end-stage renal disease requiring dialysis
* unable to give informed consent
* need of an emergency surgery
* pregnancy
Transforming Robot-mediated Telerehabilitation: Citizen Science for Rehabilitation

The purpose of this study is to advance upper limb robot-mediated tele-rehabilitation for patients recovering from stroke by empowering them through active science participation. By varying the tasks' features and affordances of a platform that combines a low-cost haptic device on one hand, and an online citizen science platform on the other, investigators will evaluate different strategies for social telerehabilitation. the two fundamental modes of social interaction - competition and cooperation - in addition to a control condition. Specifically, citizen science activities will be performed by competing, cooperating, or isolated users, and their rehabilitation effectiveness examined. Such effectiveness will be measured by (i) participants' rehabilitation performance (inferred from sensorimotor data acquired through the platform and directly quantified by a supervising therapist); (ii) participants' motivations to contribute (measured through surveys administered online); and (iii) participants' emotional well-being and sense of self-esteem (measured through online surveys).


Eligibility Criteria:
Inclusion Criteria:

For treatment group:

* post-stroke hemiparesis \>3 months
* ability to stand or sit independently
* sufficient cognitive skills to perform the exercises as demonstrated
* full passive range of motion in the affected arm but limited active movement as determined by a upper extremity Fugl-Meyer score of \<50/66
* technical savvy and interest to use an internet platform

For control group:

(ii) no history of learning disabilities (iii) technical savvy and interest to use an internet platform

Exclusion Criteria:

For treatment group:

* visual deficit such as deficit in visual acuity, eye movements, visual field cut, or neglect
* medical comorbidity such as other neurological conditions (e.g. Parkinson's disease, brain tumor, epilepsy), or previous injury to the upper limb
* pain in the upper limbs that prevents full passive range of motion to perform the exercises.

For control group:

* visual deficit such as deficit in visual acuity, eye movements, visual field cut, or neglect
* any previous injury or medical condition that prevents full passive range of motion to perform the exercises.
Diabetic Complications and Obstructive Sleep Apnea

To follow up the progress of chronic complications in T2DM patients who had undergone anthropometric measurements, laboratory testing and standard overnight polysomnography monitor from 2013 to 2018.

Obstructive sleep apnea (OSA) is a common chronic sleep disorder and a frequent comorbidity in patients with type 2 diabetes. There has been increasing recognition that OSA is highly prevalent in persons with type 2 diabetes. This study is to explore the relationship between OSA and the progress of chronic diabetes-related complications in type 2 diabetes who had undergone anthropometric measurements, laboratory testing and standard overnight polysomnography monitor from 2013 to 2018 in the Department of Endocrinology and Diabetes, The First Affiliated Hospital of Xiamen University, Xiamen, China.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Age：18-80

Exclusion Criteria:

* Patients with non type 2 diabetes mellitus
* Preparation for pregnancy
* Lactation patients
* Patients with uncontrolled thyroid disease
* Patients with severe cardiovascular disease
* Patients with severe hepatic and renal insufficiency
* Patients with oral and maxillofacial malformations and upper respiratory tract malformations
* Patients with pulmonary infection or COPD
* Patients who are not willing to accept the questionnaire survey
* Unable to sign informed consent
Florida Cerebrovascular Disease Biorepository and Genomics Center

The purpose of this study is to create a state-wide biorepository and resource center for cerebrovascular diseases in Florida, which will include collecting medical history information and blood from subjects affected by cerebrovascular disease. The information and blood samples collected may be used in future research for the study of cerebrovascular disease and to learn about, prevent or treat other health problems.


Eligibility Criteria:
Inclusion Criteria:

• Affected subjects with diverse cerebrovascular conditions, including, but not limited to, ischemic stroke, transient ischemic attack (TIA), intracerebral hemorrhage (ICH), aneurysmal subarachnoid hemorrhage (aSAH), vascular dementia (VAD), anoxic brain injury, unruptured intracranial aneurysm (UIA), cavernous malformation, arteriovenous malformations (AVM), carotid and vertebral arterial dissections, symptomatic and asymptomatic cervical carotid artery atherosclerotic stenosis, non-aneurysmal perimesencephalic subarachnoid hemorrhage (naSAH), cerebral venous thrombosis (CVT), moyamoya disease, fibrosmuscular dysplasia (FMD), non-traumatic, angiography-negative subarachnoid hemorrhage, leukoaraiosis, arteriovenous fistula, reversible cerebral vasoconstriction syndrome (RCVS), and CADASIL.

Exclusion Criteria:

• All patients with the following known or suspected virulent microorganisms causing an active or latent infection will be excluded from the study:

* Human immunodeficiency virus (HIV);
* Any viral hepatitis;
* West Nile virus (WNV);
* Influenza virus;
* Tuberculosis (TB);
* Any bacteremia;
* Any fungemia;
* Any prionopathy.
Effect of Emergency Department Care Reorganization on Door-to-antibiotic Times for Sepsis (LDS SWARM)

Sepsis is a common syndrome resulting from a dysregulated response to infection. The timing of antibiotic initiation is an important determinant of outcomes for patients presenting to the emergency department with sepsis. The potential effect of care reorganization on very early care for sepsis is unknown. This study will investigate whether multidisciplinary coordination of the initial patient evaluation in the emergency department influences door-to-antibiotic time for septic patients.

This is a retrospective cohort study of emergency department sepsis care before versus after implementation of a "swarming" model for simultaneous patient evaluation by multidisciplinary care providers. The analysis will use data from similar hospitals that did not change sepsis care organization during the study period to control for changes in sepsis care not resulting from the "swarming" intervention.

Eligibility Criteria:
Primary inclusion criteria:

* Adult patients age ≥18 years
* Presented to the ED of study hospital from May 16, 2015 to April 15, 2016 (pre-implementation cohort) or May 16 to November 15, 2016 (post-implementation cohort)
* Sepsis present in ED (Sequential Organ Failure Assessment \[SOFA\] score ≥2 points above baseline while in ED plus antibiotic initiation while in the ED)
* Triage acuity score 2-5

Inclusion criteria for supplemental sensitivity analyses:

* Presented to the ED of study hospital between May 16, 2015 and April 15, 2016 (pre-implementation cohort) or May 16, 2016 and February 15, 2017 (post-implementation cohort).
* Sepsis on presentation to ED, defined as initial Sequential Organ Failure Assessment (SOFA) score ≥2 points above baseline plus antibiotics initiation within 24 hours of ED arrival.

Overall exclusion criteria:

* Age \<18 years
* No antibiotics within 24 hours of ED arrival
Lofexidine for Adults Undergoing Lumbar Spine Surgery

The primary objective is to investigate the effects of lofexidine in adults undergoing opioid tapering prior to elective lumbar spine surgery.

In this clinical trial, an open label design will be used to facilitate opioid tapering during a 12-day period prior to elective spine surgery. The primary outcome measure of this study is the number of patients who achieve a 50% reduction in daily opioid dose at day 12.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 70 years.
2. Chronic lumbar spine pain for ≥ 3 months duration.
3. Scheduled for elective lumbar spine surgery.
4. Daily morphine equivalent dose between 50 mg and 200 mg.

Exclusion Criteria:

1. Cancer-related pain.
2. Medical or surgical conditions that could be adversely impacted by opioid tapering or use of lofexidine including, but not exclusively limited to, cardiac disease, inflammatory bowel disease, renal or hepatic impairment, vascular disease, and history of anaphylaxis. Patients may be excluded for other comorbid medical or surgical conditions based on the physician investigator's discretion.
3. History of schizophrenia or other chronic psychiatric disorder that could be adversely impacted by opioid tapering or use of lofexidine. Patients may be excluded for other comorbid mental health conditions based on the physician investigator's discretion.
4. Neurological condition that impair functioning in an ambulatory setting or could be adversely impacted by opioid tapering or use of lofexidine including, but not exclusively limited to, Parkinson's disease, amyotrophic lateral sclerosis, or a dementing illness. Patients may be excluded for other neurological conditions based on the physician investigator's discretion.
5. Active substance abuse disorder.
6. Inability to function in an ambulatory care setting due to severe deconditioning requiring use of supportive gait aids including a cane or walker. Patients may be excluded for other functional problems based on the physician investigator's discretion.
7. History of adverse effects attributed to opioid tapering or lofexidine use.
8. Use of medications from drug classes known to have adverse interactions with lofexidine including, but not exclusively limited to, beta-blockers, calcium channel blockers, alpha 1 and 2 receptor antagonists, tricyclic antidepressants, benzodiazepines, and selective serotonin reuptake inhibitors. Patients may be excluded for use of other medications based on the physician investigator's and research pharmacy's discretion.