cyrilzakka/clinical-trials huggingface dataset:
Examining Engagement Trends Among Participants in Peripheral Neuropathy Clinical Research

This trial aims to uncover the factors driving patient decisions regarding enrollment, withdrawal, or re-engagement in peripheral neuropathy clinical trials. Understanding these factors will significantly improve the relevance and effectiveness of future research endeavors.

Ultimately, this trial endeavors to deepen our understanding of the factors impacting peripheral neuropathy clinical trial participation. Enhancing participation rates could accelerate the development of innovative treatments for this debilitating condition.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years old
* Diagnosis of peripheral neuropathy
* Able to comprehend the investigational nature of the protocol and provide informed consent

Exclusion Criteria:

* Female patients who are currently pregnant or nursing
* Inability to perform regular electronic reporting
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
A Study of Real-World Outcomes of People With Crohn's Disease (CD)

The main aim of this study is to compare long-term remission in participants receiving vedolizumab (VDZ) and those receiving ustekinumab (UST).

In this study, the study doctors will review each participant's past medical records. This study is about collecting existing information only; participants will not receive treatment or need to visit a study doctor during this study.

This is a non-interventional, retrospective study of participants with CD. The study will review the medical charts of participants who have initiated the treatment with vedolizumab and ustekinumab or another biologic agent (post- index).

The study will aim to enroll approximately 700 participants, with 350 participants in each of the following cohorts:

* Cohort 1: Vedolizumab
* Cohort 2: Ustekinumab

The data for participants will be collected in two main periods:

* Pre-Index Event Period: From the date of diagnosis of CD until the date of index when vedolizumab or ustekinumab was initiated during the eligibility period.
* Post-Index Event Period: From one day post-index when vedolizumab or ustekinumab was initiated during the eligibility period until chart abstraction initiation, unless the date of death or loss to follow-up is before the date of chart abstraction initiation.

This multi-center study will be conducted in Belgium, Australia, and Switzerland. The overall time for data collection in the study will be approximately 12 months and the long-term duration of the study is approximately 36 months.

Eligibility Criteria:
Inclusion Criteria:

1. Has a diagnosis of CD documented in the medical records.
2. Has received at least one dose of vedolizumab or ustekinumab at one of the participating study sites during the eligibility period.
3. Was biologic-naïve (no prior biologic use for any pathology, including CD) at the time of index event.
4. Has completed induction phase and has a minimum of a six-month duration between the date of the index event and the date of chart abstraction initiation and was still under active care at the site six months post-index date.

Exclusion Criteria:

1. Has received vedolizumab or ustekinumab as part of a clinical trial in their lifetime (includes index event).
2. Has initiated index treatment as combination therapy with two biologic agents.
3. Has received previous treatment with biologic agents for CD or conditions other than CD ever in their lifetime.
4. Has medical chart empty or missing.
5. Part or all of the participant's index treatment was received at a different site, and the participant's medical chart pertaining to this care is not accessible.
6. Has received a subcutaneous formulation of ustekinumab for induction (that is, a subcutaneous induction dose of ustekinumab prior to ustekinumab's approval for CD in the study countries).
Effect of a Tele-rehabilitation Programme in Children With Burns: a Randomized Controlled Trial

The goal of this clinical trial is to compare tele-rehabilitation and routine post-discharge rehabilitation in children with burn injuries. The main questions it aims to answer are:

* Is tele-rehabilitation better for improving the quality and outcomes of care for burn children?
* Is tele-rehabilitation more effective in improving scar management in children with burns injuries?
* Is tele-rehabilitation more effective in improving perceived stress in parents of children with burns injuries?

In this study, experimental group received a 12-week tele-rehabilitation program, which included face-to-face access to silicone pads, pressure garments, splint and other tools necessary for burn recovery. The tele-rehabilitation program was used for intervention and regular follow-up.

The control group also received a 12-week follow-up, but only on the basis of face-to-face access to silicone pads, pressure garments, splint and other tools necessary for burn recovery.

Researchers will compare whether the trial group has better the quality and outcomes of care and scarring for children and parents who perceived stress.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria are based on the recommendations of the American Burn Association.
* Child suffered from burn injury 3-6 years old and had survived the burn event.
* The burn severity quantified by the total body surface area（TBSA）burned is equal or more than 1%.
* TBSA burned is the estimated proportion of the body with second or third degree burns.
* Burns involving neck, trunk，limbs and face.
* Only Chinese parents will be recruited.

Exclusion Criteria:

* 1.Insufficient parental Chinese language proficiency required to complete questionnaires.
* Parents cannot use social software (such as WeChat, QQ, etc.) for video, picture, and text communication after discharge.
* The main caregiver is someone other than the parents.
* Children did not live at home with their parents, such as hospitalization, boarding school, etc.
* Children who are receiving rehabilitation treatment.
* Children who have other severe disease, like cerebral palsy.
Perceval S Aortic Heart Valve Study- North America

To demonstrate the safety and effectiveness of the Perceval S heart valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.

This investigation is a prospective, non-randomized, multi-center trial of the PERCEVAL valve implanted in patients requiring aortic valve replacement. The study will be conducted in a maximum of 25 centers in the United States. Patients will be evaluated at each of the following time intervals:preoperative, at implant, in the early postoperative period, in the late postoperative period (between 3 and 6 months postoperatively), at 1 year (between 11 and 13 months postoperatively), and annually until study completion. The duration of the study is anticipated to be 5 years.

Eligibility Criteria:
Inclusion criteria:

1. Subjects of age \>= 18 years.
2. Subjects with aortic valve stenosis or steno-insufficiency.
3. The subject is willing to sign the informed consent.
4. The subject in which preoperative evaluation indicated the need for native or prosthetic aortic valve replacement.
5. The subject is located in a geographic location that will enable the subject to return to the study site for all follow-up examinations (i.e. geographically stable).
6. Subject will be available to the investigator(s) for postoperative follow-up beyond one year.

Exclusion criteria:

1. The subject has preexisting valve prosthesis or annuloplasty ring in the mitral, pulmonic or tricuspid position.
2. The subject requires a double or multiple valve replacement or repair of the mitral, tricuspid, or pulmonic valve.
3. The subject has a previously implanted PERCEVAL valve that requires replacement.
4. Subjects requiring simultaneous cardiac procedures, apart from septal myectomy and/or coronary by-pass.
5. The subject has active endocarditis.
6. Subjects with active myocarditis
7. The subject is or will be participating in a concomitant research study of an investigational product.
8. Subjects with aneurysmal dilation or dissection of the ascending aortic wall.
9. The subject is a minor, drug abuser, alcohol abuser, prison inmate, institutionalized, or is unable to give informed consent.
10. The subject has a major or progressive non-cardiac disease that, in the investigator's experience, results in a life expectancy of less than 1 year, or the implant of the device produces an unacceptable increased risk to the patient.
11. Subjects with known hypersensitivity to nickel alloys.
12. The subject is undergoing renal dialysis for chronic renal failure or has hyperparathyroidism.
13. The subject has had an acute preoperative neurological deficit, myocardial infarction, or cardiac event that has not returned to baseline or stabilized ≥30 days prior to the planned valve implant surgery.
14. Subject is known to be noncompliant or is unlikely to complete the study.
15. Subjects with an aortic root enlargement, where the ratio between the diameter of the sino-tubular junction and the annulus diameter, assessed by TTE, is \> 1.3.
Lichen Sclerosus - the Influence on Quality of Life

A randomised controlled trial of Lichen Sclerosus in a period of six months measuring Quality of Life and sexuality among women with Lichen Sclerosus.

The patients are randomized to an intervention Group and a control Group. The intervention gets 6-8 visits with clinical sexologist and the control Group is having the usual care.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Lichen Sclerosus
* Age over 18 years

Exclusion Criteria:

* Patients who does not understand or speak Danish
* Patients with a psychiatric diagnosis and can not follow the course
Stroke and MI in Users of Estrogen/Progestogen

To estimate the relative risks of acute myocardial infarction (MI) and of stroke in postmenopausal users of estrogen/progestogen (E/P) combinations and to estimate the relative risks of MI and of stroke in users of estrogen alone.

BACKGROUND:

Post-menopausal hormone use is becoming increasingly widespread based on evidence of the benefits of estrogen use for bone and the heart. However, because estrogen alone substantially increases the risk of endometrial cancer, estrogen users who have not undergone a hysterectomy are frequently also placed on a progestogen (E/P), a strategy that reduces the likelihood of endometrial cancer when compared with use of estrogen alone. In 1991, there were almost no data on the risk of cardiovascular disease in post-menopausal women who used E/P combinations.

DESIGN NARRATIVE:

The study had a case-control design, Cases were women hospitalized with MI or stroke in any of nine participating Northern California Kaiser Permanente hospitals in a 36 month period. For each case, one control, matched by year of birth, was selected at random from among members of the Kaiser Permanente Health Plan who were expected to use the same nine hospitals for their medical care. Information about use of estrogen, E/P combinations, past use of oral contraceptives, menopause, hysterectomy and oophorectomy, demographics, general health status, preventive health care, and cardiovascular risk factors were collected in interviews done of the subjects or, for fatal cases, a surrogate. Information about then current use of estrogen and E/P combinations were also gathered by reviewing medical records.

The investigators used conditional logistic regression analysis to estimate the relative risks of MI and of stroke in users of E/P combinations, taking into account prior oophorectomy and other potential confounders. They also estimated the risks of acute MI and of stroke in users of estrogen alone, accounting for prior oophorectomy and potential confounders.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
FLOAT Through Anxiety: Virtual Reality Application's Efficacy as a Tool to Distract From Negative Emotions and Thoughts

The goal of this clinical trial is to examine the effectiveness and safety of the VR FLOAT application as a tool to reduce negative thoughts and feelings and anxiety symptoms in students with high levels of stress and anxiety. The main questions it aims to answer are:

1. Will subjects with high levels of anxiety who will use the FLOAT application experience a more significant relief in feelings of anxiety compared to subjects in the control group?
2. Will subjects who are used to using technology find greater comfort in using VR compared to subjects who are not used to it?
3. What is the degree of satisfaction with the use of VR and are there any reports of side effects?Participants will \[describe the main tasks participants will be asked to do, treatments they'll be given and use bullets Researchers will compare control group to see The comparison between using FLOAT as a regulation strategy after psychoeducation on emotional regulation and cognitive-behavioral use of a regulation strategy after the same psychoeducation


Eligibility Criteria:
Inclusion Criteria:

* 'moderate' or 'severe' levels of stress and/or anxiety according to the DASS-21 questionnaire
* student

Exclusion Criteria:

* under the age of 18
* diagnoses of schizophrenia or bipolar disorder, including past or present psychotic conditions
* suicidality
* pregnant women
* do not speak or read Hebrew fluently
* a diagnosis of epilepsy.
Nicotine Pharmacokinetic Profile and Safety of the Tobacco Heating System 2.2 (THS 2.2)

The overall goal of the study is to evaluate the pharmacokinetic (PK) profile (rate and the amount of nicotine absorbed) following a single use of the THS 2.2, a candidate Modified Risk Tobacco Product, compared to the PK profiles from a single use of a cigarette (CC) and from a single use of nicotine gum in a Japanese population.


Eligibility Criteria:
Inclusion Criteria:

* Subject is Japanese.
* Smoking, healthy subject as judged by the Investigator.
* Subject smokes at least 10 commercially available CCs per day (no brand restrictions) for the last 4 weeks.
* Subject does not plan to quit smoking in the next 3 months.

Exclusion Criteria:

* As per Investigator judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason).
* Subject has received medication within 14 days or within 5 half-lives of a drug (whichever is longer) which has an impact on CYP2A6 activity.
* Female subject is pregnant or breast feeding.
* Female subject does not agree to use an acceptable method of effective contraception.
Medication Treatment for Depression in Nursing Home Residents

This study will examine therapeutic and adverse effects of continuing versus discontinuing antidepressant medication in nursing home residents who have had no more than a single episode of depression and who no longer have depressive symptoms.

There are approximately 1.6 million nursing home residents in the United States. More than one third of these residents are taking antidepressant medications (ADs). Although ADs are effective, evidence suggests that they can lead to significant adverse events, including an increased risk of falls and bone fractures. Many depressed nursing home residents suffer from an initial episode of late-life depression and do not meet guideline-based recommendations for maintenance treatment. This study will examine the benefits and risks of long-term AD treatment in depressed nursing home residents whose single episode of depression has been in continuous remission for at least six months.

Participants will be randomly assigned to either continue or discontinue AD treatment. Participants will be monitored over a period of one year for recurrence of depression and related symptoms, as well as for the occurrence of falls, fractures, and other adverse events. Medical chart review, self-reported mood symptoms, and depression scales will be used to assess participants.

Eligibility Criteria:
Inclusion Criteria:

* Current use of antidepressant medication
* Have been in remission from first episode of depression for 6 months or longer
* Currently residing in a long term care or assisted living facility

Exclusion Criteria:

* Bedridden
* Severe cognitive impairment
A Randomized Clinical Study of a Mind-Body Approach to Domestic Violence Offender Treatment

The focus of the present study is to examine the relative efficacy of a mind-body method, know as Mind-Body Bridging, of treating DV offenders as compared to a "treatment as usual" (TAU) approach. The study will be conducted on-site at ACES, a non-profit agency that provides licensed domestic violence offender and substance abuse treatment services in the Salt Lake City area.

Mind-Body Bridging Program (MBBP) was developed by Stanley Block, M.D. over the last decade drawing from his more than 30 years of experience in clinical psychiatry and awareness training. In his book Come To Your Senses: Demystifying the Mind-Body Connection (Block \& Block, 2005, 2007), he demonstrates how people can regulate their emotions through "bridging", a technique that brings one back to the present moment to experience and recognize thoughts, emotions and physical sensations. Bridging aims to reduce the impact of negative thought patterns that facilitate stress in the body. Bridging allows individuals to reconnect with a mind-body state that inherently relaxes and restores healthy natural functioning. MBBP is built on awareness practices that enable individuals to investigate their mental states at deeper levels for the purpose of calming their minds and relaxing their bodies. This can lead to reductions in activation of the stress system (stress is consistently implicated in the progression of many mental and physical diseases), with the prospect of potentially alleviating many detrimental health conditions. According to Block \& Block (2005, 2007), the critical source of ill-being in humans is rooted in the "Identity System" (IS), which is composed of self-centered thoughts, beliefs and emotions. The IS emphasizes separation, incompleteness, and self-interest, creating an identity that lacks authenticity. In essence, the IS interferes with one's natural functioning in everyday life by effectively cutting one off from one's natural self-healing abilities, and this typically results in constricting and closing down the present-moment awareness that is provided by one's senses. MBBP teaches how using bridging techniques, one can identify and "rest" the IS with its associated negativity and bodily tension, thereby creating more opportunities for improving quality of life and for functioning more naturally.

Eligibility Criteria:
Inclusion Criteria:

* Court ordered to completed domestic violence offender treatment

Exclusion Criteria:

* Do not speak English
Characterizing Protein Biomarkers of Post-infection Irritable Bowel Syndrome

The investigators will characterize and compare protein signatures between groups with and without post-infection irritable bowel syndrome (PI-IBS). From previous Healthy Nevada Project (HNP) participants, at least 60 patients with PI-IBS and 60 healthy controls will undergo additional proteomics testing, age, sex and race/ethnicity-matched healthy. The investigators will use proteomic testing to detect, quantify and characterize serum protein biomarkers and protein signatures, and compare biomarkers and signatures between the patient groups of interest. Serum samples will be analyzed by the Nevada Proteomics Center. Samples will first undergo protein digestion, then peptides are separated using liquid chromatography (LC), mass spectral analysis is performed using an Orbitrap Eclipse mass spectrometer (Thermo Scientific, San Jose, CA) using data-independent acquisition (DIA). Library generation and data analysis will be performed using Spectronaut software (Biognosys, Schlieren, Switzerland). The Nevada Proteomics Center and Bioinformatics Center will be engaged during the data analyses comparing biomarkers and signatures between the patient groups of interest. This research aim has the potential to add to our understanding of the underlying mechanisms of PI-IBS and to create reliable differentiating protein biomarkers to better diagnose PI-IBS.

The investigators will characterize and compare protein signatures between groups with and without PI-IBS. From previous HNP participants, at least 60 patients with PI-IBS and 60 healthy controls will be recruited to undergo additional proteomics testing, age, sex and race/ethnicity-matched healthy. The investigators will use proteomic testing to detect, quantify and characterize serum protein biomarkers and protein signatures, and compare biomarkers and signatures between the patient groups of interest. Serum samples will be analyzed by the Nevada Proteomics Center. Samples will first undergo protein digestion, then peptides are separated using liquid chromatography (LC), mass spectral analysis is performed using an Orbitrap Eclipse mass spectrometer (Thermo Scientific, San Jose, CA) using data-independent acquisition (DIA). Library generation and data analysis will be performed using Spectronaut software (Biognosys, Schlieren, Switzerland). The Nevada Proteomics Center and Bioinformatics Center will be engaged during the data analyses comparing biomarkers and signatures between the patient groups of interest. This research aim has the potential to add to our understanding of the underlying mechanisms of PI-IBS and to create reliable differentiating protein biomarkers to better diagnose PI-IBS.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have a Healthy Nevada Project record and linked Renown Health medical record
* Must be between 18 and 89 years of age
* Must have previously consented to being contacted and have updated contact information

Exclusion Criteria:

-None