cyrilzakka/clinical-trials huggingface dataset:
The Role of Epigenetic Mechanisms in Stress Intolerance in Patients With Chronic Widespread Pain

Patients with chronic widespread pain (CWP) frequently experience stress intolerance - an exacerbation of symptoms in response to stress. Although it severely affects their quality of life, stress intolerance remains a mystery. Hence, unravelling the mechanisms underlying stress intolerance is crucial to understand CWP pathophysiology and to develop novel treatments. Epigenetic mechanisms hold the potential to provide an answer as they have been found to be altered in patients with CWP at baseline, and in response to stress. However, research on epigenetic mechanisms in CWP is very scarce. Hence, this study aims to address this knowledge gap by assessing stress-induced epigenetic changes in patients with CWP and healthy controls aiming to unravel whether epigenetic mechanisms can help explain stress intolerance. The regulatory role of epigenetic mechanisms will be researched in relation to the activity of enzymes affected by the epigenetic mechanisms, neurophysiological measures, and stress-induced symptom changes in patients with CWP.

The objectives of this project will be tackled by a randomized cross-over study including 44 patients with CWP and 44 healthy controls. Participants are expected to come to the hospital twice and fill in questionnaires at several defined timepoints. Two days before their first visit, participants will complete baseline questionnaires at home via REDCap, which will take approximately one hour. Next, participants will be randomised into Group 1 (undergoing the mental stress test at their first visit and then relaxation breathing) or Group 2 (undergoing relaxation breathing at their first visit and then the mental stress test). During each hospital visit, the participants will be assessed before, during and after the intervention. The Pre-test assessment consists of a blood withdrawal, five short questionnaires, examination of pain thresholds, and neurophysiological measurements. The latter will continue during the intervention, which consists of a mental stress test or relaxation breathing. The Post-test assessment consists of a blood withdrawal, one short questionnaire, examination of pain thresholds, and neurophysiological measurements. Then there are again 2 home-based assessments via REDCap 24h and 7 days after the intervention during which the participants will in 1 or 5 short questionnaires, respectively.

Eligibility Criteria:
Inclusion Criteria:

* female
* age between 18 and 70 years old
* body mass index (BMI) below 30
* inactive lifestyle
* for patients only: received the diagnosis of fibromyalgia

Exclusion Criteria:

* other neurological, endocrine, cardiac, or systemic syndromes
* history of cancer or heart failure
* women that are pregnant or within one year after pregnancy
Feasibility & Characterization of Project: EVO Monitor Cognitive Measurements

This is an open-label study in adults to assess at-home Project: EVO Monitor measurements over repeat play cycles. The study has three arms:playing multiple times per day, once daily, and once weekly for 4 to 8 weeks.

This is an open-label study in adults ages 40 to 55 to assess Project: EVO Monitor measurements over repeat play cycles. The study has three arms: adults playing multiple times per day, adults playing once daily, and adults playing once weekly. The investigators plan to evaluate 76 participants (N = 30 in the daily and weekly arms, and N=16 in the multiple times per day arm) in two sites over a 4 to 8 week study period. The study period includes 2 in-clinic sessions and scheduled, at-home game play of the short (less than 7 minutes) Project: EVO Monitor.

Eligibility Criteria:
Inclusion Criteria:

* Age: 40-55 at the time of informed consent
* Ability to follow written and verbal instructions (English).
* Male and Female (Gender-matched).
* Ability to comply with all the testing and requirements.

Exclusion Criteria:

* Current, controlled (requiring a restricted medication) or uncontrolled, self-reported psychiatric diagnosis with significant symptoms such as post-traumatic stress disorder, psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder, conduct disorder, attention deficit disorder, autism spectrum disorder, or other symptomatic manifestations that in the opinion of the Investigator that may confound study data/assessments.
* Current self-reported community diagnosis of cognitive ailments such as dementia, Alzheimer's disease, stroke, traumatic brain injury, or other diseases that in the opinion of the Investigator that may confound study data/assessments.
* Current diagnosis of severe learning disorder, dyslexia, or dyscalculia.
* Current subjective complaints of inattention or memory loss.
* Current use of psychotropic medication, prescription or otherwise.
* Currently undergoing psychotherapy, behavioral therapy, or occupational therapy.
* Motor condition that prevents game playing, as observed by investigator.
* Impaired visual acuity, as defined by difficulty reading the informed consent even with corrective lenses.
* Recent history (within the past 6 months) of suspected substance abuse or dependence.
* History of seizures (exclusive of febrile seizures), a tic disorder, significant tics, a current diagnosis of Tourette's Disorder.
* Taken part in a clinical trial within 30 days prior to screening.
* Diagnosis of color blindness.
* Regular use of psychoactive drugs that in the opinion of the Investigator may confound study data/assessments
* Any other medical condition that in the opinion of the investigator may confound study data/assessments.
Developing a Telehealth + MHealth Cannabis Use Intervention for Young Adults

The goal of this clinical trial is to determine 1) feasibility of the MOMENT-V intervention for cannabis use disorder in young adults, 2) feasibility of conducting the trial remotely, and 3) whether the MOMENT-V intervention reduces cannabis use frequency and problems. Researchers will compare the MOMENT-V intervention to usual care enhanced by a counselor meeting.

Participants will either meet with a counselor two times and use an app on their phone for two weeks, or meet with a counselor briefly one time. All participants will be asked to complete electronic surveys, interviews with a research assistant, and saliva drug testing at home over three months.


Eligibility Criteria:
For the oral fluid testing pilot

Inclusion Criteria:

* Primary care patient of the Boston Children's Hospital Adolescent/Young Adult Medicine Practice
* Participation in MOMENT-V open pilot
* Ownership of a smartphone
* Availability for the 2-week study duration

Exclusion Criteria:

* Inability/Unwillingness to provide contact information
* Current pregnancy or parenting

For the pilot RCT

Inclusion Criteria:

* Primary care patient of the Boston Children's Hospital Adolescent/Young Adult Medicine Practice or Martha Eliot Health Center Adolescent Clinic
* 18 to 26 years old
* Cannabis Use Disorders Identification Test-Revised (CUDIT-R) score of ≥12
* Recreational cannabis use on \&gt;3 days/week, on average, in the past 30 days
* Ownership of a smartphone that is PIN- or password-protected
* Ability to read and speak English
* Availability for the 6-month study duration

Exclusion Criteria:

* Inability/Unwillingness to provide contact information
* Written certification from a physician for marijuana for medical use
* Current participation in a substance use treatment program or research study
* Current pregnancy or parenting
* Participation in prior MOMENT or MOMENT-V research
Effects of Sevoflurane and Ketamine on QT in Electroconvulsive Therapy

The aim of this study was to evaluate the effect of sevoflurane or ketamine on the QTc and Tp-e interval during in patients with major depression.

Patients enrolled in the study are randomly allocated by computer-generated random numbers to receive either sevoflurane or ketamine for their initial ECT session. They subsequently receive an alternative study drug in their next session, continuing to alternate between drugs at each session until the sixth session. In group S, sevoflurane are initiated at %8 sevoflurane for anesthesia induction and maintained at 2% to %4 until the electrical stimulus is delivered, In group K, ketamine are given to 1mg/kg ıv bolus.

Electrical stimulus is delivered via bilateral frontotemporal electrodes.The mean arterial pressure (MAP), HR, and ECG are recorded before anesthetic induction (T1), after anesthetic induction (T2) and at 0, 1, 3, 10 min after the seizure ended (T3, T4, T5 and T6, respectively).The QT interval and Tp-e interval are measured by one author, who was unaware of group allocation.

Eligibility Criteria:
Inclusion Criteria:

* Unpremedicated
* American Society of Anesthesiologists (ASA) I-II the patients
* Major depressions patients scheduled for ECT sessions

Exclusion Criteria:

* pregnant
* with permanent pacemakers,
* diabetes mellitus,
* atrial fibrillation,
* electrolyte imbalance,
* patients taking antiarrhythmics and β-blockers.
Anti-inflammatory Effect of Peroperative Stimulation of the Vagus Nerve

Hypothesis:

Electrical stimulation of the abdominal vagus nerve has anti-inflammatory effects which lead to a faster postoperative recovery after abdominal surgery.

Aims:

In the present study, the investigators want evaluate the anti-inflammatory effect of peroperative electrical stimulation of the vagus nerve. In addition, the investigators want to determine whether vagus nerve stimulation leads to a faster postoperative recovery. To this end, the following aims are formulated:

1. to determine whether vagus nerve stimulation leads to an improvement in gastrointestinal transit using radiological testing
2. to evaluate whether electrical stimulation of the vagus nerve leads to clinical improvement (daily questionnaire)
3. to show that electrical stimulation of the intra-abdominal vagus nerve reduces the inflammatory response to abdominal surgery


Eligibility Criteria:
Inclusion Criteria:

* patients with ovarium, pancreas or colorectal carcinoma eligible for resection

Exclusion Criteria:

* preoperative therapeutic abdominal radiation shorter than 2 weeks prior to surgery
* evident intra-abdominal inflammation (diagnosed by imaging and/or laboratory test results, including abscess or cholecystitis)
* American Society of Anesthesiologists physical-health status classification (ASA-PS) \> 3
* poorly regulated diabetes (\> 200 mg/dl (= 11 mmol/l)
* surgery due to chronic pancreatitis
Incidence of Complete Posterior Vitreous Detachment After Trabeculectomy.

Intraocular surgery could induce vitreous degeneration and posterior vitreous detachment (PVD). Vitreomacular interface (VMI) abnormalities usually are caused by abnormal PVD, vitreoschisis and partial-thickness PVD. Furthermore, the PVD could induce the peripheral break. The incidence of peripheral break and epimacular membrane (EMM) after pneumatic retinopexy were 11.7% and 4-11%, respectively. Although multiple intravitreal anti-vascular endothelial growth factor (anti-VEGF) injections induced PVD of 5.6%, but peripheral break was reported as only 0.67%.

The most common intraocular surgery is cataract surgery. From the literature review, many methods were used to detect the PVD after phacoemulsification. The former studies used indirect ophthalmoscopy and ocular ultrasound for diagnosis of PVD. The later studies used the optical coherence tomography (OCT) for PVD detection. The OCT device had higher effectiveness in evaluation of the posterior segment, then it can detect post-phacoemulsification PVD more and early than previous studies. Ivastinovic et al demonstrated 59.2% of patients had PVD at 1 month after phacoemulsification, and increased up to 71.4% at 3 months. The incidence of rhegmatogenous retinal detachment (RRD) after phacoemulsification is gradually increased with time. The accumulative risk of RRD was increased from 0.27% at 1 year to 1.27% at 20 years after phacoemulsification.

Trabeculectomy is one of the intraocular surgery. Although the volume of intraocular fluid use during the trabeculectomy was much less than used during phacoemulsification, trabeculectomy also could induce the PVD and it's sequelae such as VMI abnormalities. Because the baseline visual acuity of glaucoma patients who were indicated for trabeculectomy usually quite poor, so the sequelae of PVD can cause more visual loss. The incidence of PVD after trabeculectomy has never been published before and nowadays no standard guideline for retinal examination or screening after surgery. Furthermore, Tsukahara et al introduced wide-field OCT-based PVD classification. The new OCT device with higher technology will be useful in PVD detection.

Eligibility Criteria:
Inclusion Criteria:

* Primary open angle glaucoma or primary angle closure glaucoma
* Age 18-65 years
* Could be taken the wide-field OCT images
* Written informed consent

Exclusion Criteria:

* History of intraocular inflammation or infection
* History of ocular trauma or head trauma
* History of intraocular surgery such as intravitreal drug injection and cataract surgery
* History of vitreoretinal diseases such as diabetic retinopathy, retinal vascular occlusion and age-related macular degeneration
* History of laser treatment including laser capsulotomy and retinal photocoagulation
* High myopia; spherical equivalence \>4 diopters
* Complete PVD was detected before the enrollment
Peri-Implant and Peri-Prosthetic Fractures: Epidemiology, Morbidity, Mortality, Treatment and Outcome Analysis

This study supports Spanish data collection and analysis on Periprosthetic and Peri-implant fractures of the upper and lower limb. Treatment and clinical management of this fractures are complex and goes along with complications. There will be more than 70 hospitals providing information. This study will provide evidence on which is the best treatment for every unique patient. This will help trauma surgeons and geriatricians to provide better treatments, to improve health care in our society, reducing mortality, morbidity, improving functional outcomes, and reducing costs, which in turn will be advances in trauma care.

There is no clinical evidence on which are the best treatment options for Periprosthetic and Peri-implant fractures of the upper and lower limb. This is a multi-center collaborative study seeking to obtain a big number of patients. Data collection includes previous health status and quality of life, which is the clinical management and treatment, as well as the outcome after one month, six months and one year. The investigators will be able to define risk factors and clinical attitudes, which influence on the patient outcome. And therefore, be able to establish treatment protocols and give management recommendations based on the observed clinical evidence to improve healing indexes, morbidity and mortality, function, grade of autonomy and quality of live.

Main questions to be answered are: 1. which is the epidemiology of Periprosthetic and Peri-implant fractures and how are they treated in Spain, 2. Identify risk factors for complications and worse outcomes, 3. which is the morbidity and mortality, 4. influence of the fracture type and implants already placed on management and outcome, 5. influence of the treatment on patients' grade of independency, and 6. identified which are the risk factors for treatment failure.

Eligibility Criteria:
Inclusion Criteria:

* Patient with the diagnose of Periprosthetic fracture of the shoulder, elbow, hip or knee. Or patients with the diagnose of Peri-implant fracture of the scapula, humerus, forearm, pelvis, femur, patella, tibia or fibula. Or patient presenting cut-out or cut-in after DHS or nail after a proximal humeral fracture.
* 18 years or older

Exclusion Criteria:

* Spine PP or PI fracture
* PP or PI secondary to metastasis or tumoral fracture
* PP or PI intraoperative fracture
* PP or PI pathologic fracture
* PP ankle fracture
* PP or PI wrist or hand fracture
* Fixation failure without any new fracture line: except cut-out or cut-in after DHS or nail of a proximal humeral fracture.
* Pregnancy
A Study Investigating The Effects Of An Ankle Rehabilitation Program On High School Athletes With Ankle Instability

A randomized controlled trial investigating the effects of a 4-week ankle rehabilitation program on high school athletes with chronic ankle instability.

A randomized controlled trial investigating the effects of a three different 4-week ankle rehabilitation programs on high school athletes with chronic ankle instability. We will use questionnaires to assess subjective level of function and clinical measures to assess clinical functionality via static and functional balance.

Eligibility Criteria:
Inclusion Criteria:

* active for at least 1.5 hours a week, a history of at least 1 significant ankle sprain that required medical intervention, repeated symptoms of pain, swelling, weakness, instability, and repeated episodes of "giving way".

Exclusion Criteria:

* presence of any current lower extremity injury (diagnosed by a medical professional within last 3 months with present symptoms), previous surgery to either leg, diagnosed ankle sprain within the past 6 weeks, history of ankle fractures and/or dislocations.
Addressing Health Disparities in African Americans - Exploring Sleep and Developing Interventions

The purpose of the HD-SLEEP1 study is to help researchers understand what African Americans know and think about sleep. The investigators also want to know how to encourage people to participate in research studies designed to improve sleep.

African Americans (AAs) sleep worse than whites on average, thus contributing to race disparities in major health outcomes. However, contributors to poorer sleep and effective interventions to improve sleep among AAs is lacking due to under-representation of AAs in sleep research. The investigators propose to address this knowledge gap through engagement with the Baton Rouge African American community. The investigators will use focus groups to determine sleep-related perceptions as well as barriers to sleep research recruitment and retention.

In this study, up to 60 African Americans who self-report poor sleep will be invited to participate in focus group discussions to understand 1) sleep related perceptions; 2) factors influencing participation; and 3) willingness to undertake study procedures typical of sleep research studies such as increasing sleep duration, diagnosing and treating OSA; along with other routine research procedures including blood draws, caloric restriction, and body composition exams.

Eligibility Criteria:
Inclusion Criteria:

* Self-identified African American
* Age range: \>18 years (inclusive)
* Sex: Both males and females will be allowed to participate in the study
* Self-perceived poor sleep
* Willing to be audio and video recorded

Exclusion Criteria:

* Unable to provide written informed consent
* Unable to understand English
An Analysis of the Relative Risk for Low Triiodothyronine Syndrome in Patients With Chronic Radiation Enteritis

Radiation enteritis (RE) is by simple definition an inflammatory process occurring at the level of the intestines as a response to abdominal or pelvic radiation energy exposure. Due to the dosage of radiation, sensitivity of organs to radiation, and some patient characteristics, RE can present as either an acute or chronic syndrome. Clinical manifestations differ but may include abdominal pain, malabsorption, diarrhea, cachexia, intestinal bleeding, obstruction, and even perforation, which compromise quality of life. For many years, radiotherapy of the abdominal or pelvic region is commonly used for a significant percentage of patients with rectosigmoid and genitourinary system tumors. Different techniques have been developed to prevent the occurrence of radiation induced injury. However, the incidence of CRE is expected to continue to rise during the coming years. What's more, abdominal or pelvic radiotherapy can also lead to other side effects in addition to RE, such as skin desquamation, local soft tissue injury, and so on. Till now, lots of attention is only paid to local complications, there is little report on systemic damage of abdominal or pelvic radiotherapy.

Low triiodothyronine syndrome (LT3S), a condition characterized by low circulating triiodothyronine (T3) levels, normal thyroxine (T4), free thyroxine (FT4) and thyroid-stimulating hormone (TSH) levels in the absence of an intrinsic thyroid disease, is variously known as the "nonthyroidal illness syndrome (NTIS)". This condition is frequently detected in critical illness. Reichlin et al. first noticed that some aspects of thyroid hormone metabolism might change during many chronic illnesses as early as 1973. Data has shown that about 35-70% of acute and chronic critical conditions were associated with a significant abnormal thyroid hormone metabolism, of which LT3S was the most common type. Furthermore, these changes have been shown to be associated with disease severity and have been connected with poor short-term prognosis.

To date, there are lots of literatures include detailed reports on the relationship between LT3S and chronic illnesses such as rheumatoid arthritis, systemic lupus erythematosus, sepsis, and so on. However, no systematic analysis of LT3S in patients with CRE has been undertaken. As such, the present study aimed to investigate the frequency of LT3S in CRE patients.


Eligibility Criteria:
Inclusion Criteria:

* patients with chronic radiation enteritis
* patients with some kinds of malignant tumors but had not previously received radiotherapy
* age-matched healthy volunteers

Exclusion Criteria:

* Patients with a chronic disease other than CRE, including RA, SLE, thyroid illness, infectious diseases, and hepatic or renal disorders were excluded.
* patients have taken any drugs that may influence thyroid hormone secretion and metabolism during the previous 3 months.