cyrilzakka/clinical-trials huggingface dataset:
Exploring the Link Between Pain and Distress in Adolescent Patients with Chronic Pain

The primary aim is to explore what it is about the experience of chronic pain that may cause emotional distress in some young people but not in others, and how particular individual characteristics, as well as family factors may contribute to young persons' pain experiences and their emotional responses to pain.

This is a three-part observational follow-up study:

Part one will explore (a) whether the current sample reports emotional distress, including feelings of burdensomeness, hopelessness and thoughts and acts of self-harm, and if young people perceive there to be a link between pain and any such feelings of distress, and (b) which aspects of the pain experience, if any, are associated with such distress, using qualitative and quantitative data.

Part two will explore potential individual-level and family-level risk and resilience factors underpinning the hypothesised relationship between aspects of the pain experience and burdensomeness, hopelessness and thoughts and acts of self-harm, using adolescent and parental baseline data.

In part three, adolescent participants will be invited to complete daily diaries on their pain experience, three times per day over 7 days, in order to investigate which aspects of the pain experience are associated with burdensomeness and hopelessness at follow-up.

This study has the potential to improve the care of young people with chronic pain, and in particular the emotional support that young people receive.

Eligibility Criteria:
Inclusion Criteria:

Part 1: Adolescents

* Participant is willing and able to give assent (aged 12-15) or informed consent (aged =\>16) for participation in the study
* Adolescents aged 12 to 19 years
* Self-reported experience of chronic pain (i.e., recurrent and/or persistent pain at least once per week for at least 3 months).
* Able to read and converse fluently in English
* Parent/carer willing to give informed consent for participants aged 12-15

Part 2: Adults

* Participant is willing and able to give informed consent for participation in the study.
* Participant is the parent/carer for a child aged 12 to 19 years, with chronic pain (i.e., recurrent or persistent pain at least once per week for the past 3 months), and this child is participating in this study.
* Able to read and converse fluently in English

Additional criteria for Part 3: Follow-up part

· In possession of a smartphone to complete the momentary assessments.

Exclusion Criteria:

Part 1: Adolescents

* If some type of serious pathology (e.g., infection, fracture, disease process (e.g., cancer)) or surgical procedure is the cause of the resulting pain complaint.
* If the patient is too psychologically unstable (e.g., experience of hallucinations or delusions, or with known acute suicide risk) to safely participate in this research, based on clinical judgment.

Part 2: Adults

-If the clinical care team thinks the parent/ caregiver is unsuitable for this study.

Additional criteria for Part 3: Follow-up part

-Inability to provide data via the use of a smartphone
Long-term Follow-up Study to Evaluate Safety and Efficacy of FBX-101 in Krabbe Patients

This is an observational study that will enroll any patients with Krabbe disease that have participated in prior interventional clinical trials involving the administration of FBX-101.

FBX-101-LTFU is a multicenter, non-interventional, Long-Term Follow-Up (LTFU) study of participants from prior interventional trials involving the administration of FBX-101. Eligible participants will undergo clinical evaluations at prespecified intervals for at least 3 years from the last visit in the prior clinical trial (up to 5 years post-FBX-101 treatment). Overall safety and additional signs of efficacy will be collected with a series of laboratory tests, diagnostic tests, and performance surveys. Additionally, children participating in interventional trials that are terminated early will be transferred to this LTFU study and will complete any pending visits from the interventional trial before starting the clinical evaluations included in this protocol.

Eligibility Criteria:
Inclusion Criteria:

* Participants that have completed a prior clinical trial involving the administration of FBX-101.
* Parent(s)/legal guardian(s) of participant willing and able to complete the informed consent process and comply with study procedures and visit schedule.

Exclusion Criteria:

•Planned or current participation in any other interventional clinical study that may confound the safety or efficacy evaluation of FBX-101 during this study.
Abdomen CT and Open Appendicectomy：New Diagnostic and Surgical Procedures

The traditional open appendectomy in the clinical effect is not prefect, and for a long time there is no measurable improvement. The application of abdomen CT before surgery provides a new approach to the incision and new perception.

In a randomized controlled trial of modified incision versus traditional incision. Length of hospital day was the primary terminus, while operating time, postoperative complication, scar and time to resume normal activity and work as secondary terminus.

Traditional open appendicectomy have many drawbacks, such as false-positive, cut infection, scar, extended cut, slower rehabilitation and return to work. In the past few years, in order to improve diagnostic accuracy, the abdomen CT is been general applied before appendicectomy, in addition to, a modified incision (MI) was designed based on it. Using a MI compare traditional incision (TI) to the patient including cut extended, operating time, cut infection, false-positive rate, rehabilitation and return to work. It seems that MI would prove superior to TI in terms of hospital day (primary terminus), with operating time, postoperative complication, scar and time to resume normal activity and work as secondary terminus.

Eligibility Criteria:
Inclusion Criteria:

* patients with a clinical diagnosis of acute appendicitis

Exclusion Criteria:

* children under 14 are not included
Use Babyguard® Breast Milk Probiotics to Verify the Authenticity of the Gut-Breast Axis Hypothesis

In order to understand the life history of the breast milk flora, explore its composition, source of strains, and ability to colonize the baby's intestinal environment, to find out strains with the potential of probiotics in breast milk

This is a double-blind and randomized study. After being discharged from the hospital, the subject was notified to consume the Babyguard breast milk probiotic daily for 1 month, and observe whether the mother's stool, breast milk and baby stool samples can find the same strain. The clinical diagnosis items of the bacterial strains of mother feces, breast milk and baby feces samples are evaluated by the doctor.

Eligibility Criteria:
Inclusion Criteria:

* At least 20 years old, pregnant women with non-high-risk pregnancy risk assessed by obstetricians and gynecologists, healthy mothers and infants with no abnormal obstetric examination results

Exclusion Criteria:

* Pregnant women who have used oral or injectable antibiotics within three months before delivery, or women who need a cesarean section for any reason during pregnancy
An Observational Study to Evaluate the Clinical Effectiveness, Quality of Life, Safety and Tolerability of Tocilizumab (TCZ) in Patients With Rheumatoid Arthritis (RA) in Daily Clinical Practice

This observational trial will evaluate the effectiveness, the consistency of evaluation scores, quality of life, safety and tolerability of TCZ administered subcutaneously (SC) in participants with RA in daily clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Participants naive to TCZ or who have received TCZ SC treatment within 8 weeks prior to the enrolment visit can be included
* Participants in whom the treating physician has made the decision to commence TCZ SC in accordance with the label and reimbursement criteria

Exclusion Criteria:

* Participants who have received TCZ \>8 weeks prior to the enrolment visit
* Participants who have previously received TCZ SC
* Participants who have received treatment with any investigational agent within 4 weeks before starting treatment with TCZ SC
International T1 Multicentre CMR Outcome Study

Myocardial fibrosis is the fundamental substrate for the development of heart failure.

Cardiovascular magnetic resonance (CMR) allows non-invasive assessment of myocardial fibrosis based on late gadolinium enhancement (LGE) and T1 mapping.

Patients: Prospective longitudinal observational multicenter study of consecutive patients with suspected or known non-ischemic cardiomyopathy.

Imaging: Non-invasive measures of myocardial fibrosis: native T1, extracellular volume fraction (ECV) and LGE.

Primary endpoints: all cause and cardiovascular mortality.

Secondary endpoints: arrhythmic composite and HF composite endpoints.


Eligibility Criteria:
Inclusion Criteria:

1. adults \> 18 years of age
2. clinical indication for CMR
3. able to provide informed consent

Exclusion criteria:

contraindications for cardiac magnetic resonance imaging due to MR unsafe devices or objects
STREAMLINE®SURGICAL SYSTEM Compared to iStent Inject W® in Patients With Open-Angle Glaucoma

A study of the Streamline Surgical System versus competitor


Eligibility Criteria:
Inclusion Criteria:

Diagnosis of Mild to Moderate Primary Open Angle Glaucomma

Exclusion Criteria:

* Other types of glaucoma including but not limited to: Normal tension glaucoma, pseudoexfoliative glaucoma, narrow angle glaucoma, traumatic, congenital, malignant, uveitic or neovascular glaucoma. Ocular hypertension.
A Study To Investigate How The Body Handles Multiple Doses Of PF-0243873 And To Investigate The Effect Of PF-02413873 On Sex Hormone Levels In Healthy Young Women

The study will investigate how well multiple doses of PF-02413873 are tolerated by healthy young women, how the body handles multiple doses of PF-02413873 and which effect PF-02413873 has on sex hormones in healthy young women


Eligibility Criteria:
Inclusion Criteria:

* Healthy women of childbearing potential with a regular menstrual cycle

Exclusion Criteria:

* Evidence or history of any major disease
* Pregnant or nursing women
* Requirement for chronic medication
Study to Evaluate the Relative Bioavailability of Two Risankizumab Drug Product Presentations in Healthy Volunteers.

This study will assess how safe risankizumab is and how risankizumab moves through the body of adult healthy participants. Adverse Events will be assessed.

Risankizumab is an investigational drug being developed for the treatment of Crohn's Disease. Participants are randomly assigned to one of the 2 treatment groups. Approximately 198 adult healthy volunteers will be enrolled in at least 4 sites across the world.

All participants will receive risankizumab as subcutaneous injections in one of the 2 different formulations.

There may be higher burden for participants in this trial. Participants will be confined for 10 days and followed up for 140 days. Adverse Events and blood tests will be collected.


Eligibility Criteria:
Inclusion Criteria:

- Body weight greater than 40 kg and less than 100 kg at screening and upon initial confinement.

Exclusion Criteria:

* Previous exposure to any anti-interleukin-12/23 or anti-interleukin-23 treatment.
* Intention to perform strenuous exercise to which the participant is unaccustomed within one week prior to administration of study drug or during the study.
Dexmedetomidine for Sepsis in ICU Randomized Evaluation Trial

Background:

Dexmedetomidine, a highly selective arfa2-adrenergic agonist, is known to be a unique sedative agent which causes less acute tolerance, drug addiction and withdrawal compared with gamma-aminobutyrate (GABA) agonists. Dexmedetomidine was approved for short-term ICU sedation in 2004 in Japan, and it has been used particularly for surgical ICU patients. In August 2010 dexmedetomidine was approved in Japan for sedation lasting more than 24 hours.

Recent evidence demonstrated that dexmedetomidine has organ protective effects including neuroprotection, cardioprotection, renal protection, gastrointestinal tract action, and anti-inflammatory action. Dexmedetomidine was shown to significantly decrease the infarct size in isolated rat hearts. Additionally, dexmedetomidine exhibited a preconditioning effect against ischemic injury in hippocampal slices, and this result was considered an apoptosis suppression effect of dexmedetomidine. Aydin C et al reported that dexmedetomidine enhanced the spontaneous contractions of the ileum in peritonitis rats compared with propofol and midazolam. Taniguchi and colleagues demonstrated that dexmedetomidine reduced high mortality rates and the plasma cytokine concentrations, interleukin-6 and tumor necrosis factor alpha in endotoxemic rats.

A meta-analysis has shown that perioperative alfa2-adrenergic agonists, including dexmedetomidine infusion, decreased cardiovascular events on patients undergoing cardiac surgery. Dexmedetomidine treated patients undergoing thoracotomy indicated increase in urine output, reduction in serum creatinine, and the suppression of diuretics in a randomized placebo-controlled double-blind study. Septic patients receiving dexmedetomidine had improved 28-day mortality rates compared with septic patients receiving lorazepam in a sub-group analysis of MENDS randomized controlled trial.

These positive effects of dexmedetomidine on the cardiovascular system, neurons, kidneys, gastrointestinal tract action, and an anti-inflammatory action, are expected to improve mortality in septic patients. However, large clinical research studies have not been conducted yet. We designed and conducted the DESIRE trial (DExmedetomidine for Sepsis in ICU Randomized Evaluation trial) to test a hypothesis that dexmedetomidine may improve clinical outcome and has these organ protective effects on septic patients.

Objective:

To determine whether dexmedetomidine improves clinical outcome and has organ protective effects on septic patients.


Eligibility Criteria:
Inclusion Criteria:

* adult
* transferred to ICU
* anticipation of a need for mechanical ventilation at least 24 hours

Exclusion Criteria:

* sever chronic liver disease (Child B or C)
* acute myocardial infarction, heart disease (NYHA 4)
* Drug dependence, alcoholism
* Psychological illness, severe cognitive dysfunction
* patients who have allergy for dexmedetomidine
* attending physician's decision
Financially-Incentives to Improve Provider Compliance

The main objective of this study is to assess whether making health financing streams conditional on provider performance on knowledge assessment can increase provider compliance with under-5 case management guidelines.

The main idea of the intervention is to conduct quarterly provider knowledge assessments at health facilities and to pay facilities a bonus if providers perform well on these tests. For the intervention, 12 clinical vignettes were created. These vignettes cover typical patient cases such as malaria, diarrhea and respiratory infections, and assess providers' ability to correctly diagnose and treat hypothetical questions. All medical staff members were informed hat every 3 month there would be a knowledge assessment based on these vignettes and that the results would determine the total bonus payment made to the facility.

Each quarter, facilities receive a supervision visit. During the supervision visits, one provider is randomly chosen for the knowledge assessments, and is tested on two randomly chosen vignette cases.

In order to create a quarterly performance score, the scores on the two vignettes are then averaged. Fifty percent of the overall facility quality score is determined by the general quality checklist that captures basic structural and process features of the facility. The remaining fifty percent are directly determined by the providers' performance on the knowledge assessments. If the overall quality score is below 50%, no quality payments are made. If the quality score is \>=50%, facilities can receive a top-up payment of up to 25% of the quantity-based payments. The total bonus percentage is determined by multiplying the quality score (with ranges between 0 and 100%) with the maximum 25% bonus.

Eligibility Criteria:
Inclusion Criteria:

* all providers working at the 110 facilities selected for the study will be included in the study.

Exclusion Criteria:

* none.
"Guarantee Assessment in Skin Prevention Adapted to Real Life With a Connected Device After a Spinal Cord Injury."

The investigators propose to test an embedded device on the seat of the wheelchair of paraplegic or tetraplegic patients (Gaspard), allowing on the one hand the continuous measurement of the pressures of seat, on the other hand a retro-control connected to the cell phone of the participants to inform them on these variables of seat (bad positioning, prolonged supports etc...) This study will be carried out over a long period of time (1 year), in an ergonomic situation of integration in the daily life of the participants. The main objective of this randomized controlled study is to study the difference in the incidence of pressure sores according to the use or not of this device. A qualitative study of the experience and perceived benefit of its use and a medico-economic study are associated to judge the expected interest in making this type of embedded device more systematically integrated into the classic movement equipment (wheelchair and seat cushion) of people with a spinal cord injury


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes with acquired spinal cord injury Traumatic or non-traumatic origin of the spinal cord injury

  * Motor level \< C6
  * Complete or incomplete injury (AIS A, B and C impairment scale)
  * Primarily using a manual wheelchair (with or without electric propulsion assistance) as a means of mobility
  * At least 18 years of age
  * At any time after the occurrence of the spinal cord injury
  * Patients discharged from the center, with a first post-injury rehabilitation completed
  * Having participated in a specific therapeutic patient education on pressure ulcer prevention
  * No pelvic pressure sores under medical or surgical treatment at the time of inclusion
  * No aorto-iliac arterial disease that may promote pelvic ischemia (arterial Doppler \<6 months)
  * Patient using a cushion approved by the HAS
  * Patients with a smartphone

Exclusion Criteria:

* Congenital spinal cord injury
* Motor level of the lesion \> or = C6
* Incomplete motor lesion (AIS D and E)
* Patients who walk as their primary mode of ambulation
* Use of an electric wheelchair
* Minors
Diaphragmatic Breathing as an Adjunctive Therapy in the Management of Children With Bladder and Bowel Disorders

Urination is a result of a complex neuro-muscular coordination which involves the action and arrangement of different parts of nervous systems as well as the muscular structure of the lower part of the urinary system. When there is an abnormal pattern in bladder and bowel habits without any known neuronal lesions, the condition is called bladder and bowel disorder (BBD). The symptoms can range from the feeling of rushing to the toilet, urinary accidents to urinating much less than expected during the day.

The standard treatment for most cases of BBD starts with Standard Urotherapy (SU) which is a beneficial basic and harmless form of treatment widely used for all children with BBD. SU involves explaining of the problem to the children and their parents by the doctors and educating them on proper voiding mechanisms, sitting, and standing positions as well as how and when to void.

The purpose of this study is to explore the possibility of testing the additive effectiveness of Diaphragmatic Breathing exercise (DB) as an alternative and harmless additional treatment to SU in children with BBD.


Eligibility Criteria:
Inclusion Criteria:

1. Children with bladder and bowel disorders (BBD) will be diagnosed by the attending pediatric urologists via a combination of thorough clinical history, physical examination, BBD Questionnaire, uroflowmetric evaluation, and voiding and stool diary.

Exclusion Criteria:

1. Known anatomic or neurological lower urinary tract abnormalities such as posterior urethral valve, urethral obstruction or stricture, ectopic ureters, congenital abnormalities of the spinal cord, or any previous surgery of the lower urinary tract.
2. Current use of medication or treatments which affects bladder or ANS function. These include anti-cholinergics, anti-psychotics, anti-depressants, and neuromodulators.
3. Any conditions or disorders that would affect the cardiovascular system or the activity of the ANS.
4. Serious pulmonary issues or diaphragmatic problems that would interfere with the practice of diaphragmatic breathing technique.
5. Psychological/behavioral abnormalities severe enough to prevent the cooperation of the child with the study coordinator or the urologist.
6. Inability to provide consent.
7. Inability to speak and/or understand in English.
Pilot of Mpowerment for Young Men Who Have Sex With Men (YMSM) in Beirut

This project will adapt and pilot a multi-level, community-based intervention to promote HIV prevention and sexual health among young men who have sex with men in Beirut.

Mpowerment (MP) is an evidence-based community-level, structural, social and behavioral intervention for HIV prevention developed for YMSM that targets individual and community empowerment and mobilization, self-affirmation, sexual self-knowledge, and creation of a supportive social environment. MP has been widely used in the U.S., but not in a mostly Muslim setting. This project will adapt and pilot MP for the sociocultural issues facing YMSM (age 18-29) in Beirut. There will be a 2-year pilot implementation of MP, with longitudinal cohorts of YMSM in Beirut and Jounieh, the latter being the control community. Primary outcomes will be unprotected anal sex and HIV testing, with secondary outcomes being engagement in peer outreach, and perceived peer norms related to condom use and HIV testing.

Eligibility Criteria:
Inclusion Criteria:

* men aged 18-29, who have had anal sex with men in the past 6 months

Exclusion Criteria:

* not residing in Lebanon