cyrilzakka/clinical-trials huggingface dataset:
Lifestyle Remodeling in Subjective Memory Complaint (SMC): Brain Imaging and Blood Biochemistry Study

The specific study aims:

1. To investigate whether the brain function is affected by the past life experiences, such as lifestyle and physiology-related factors in SMC.
2. To examine whether the lifestyle remodeling could improve SMC's cognitive function and modulate the reactivity of inflammatory factors, leading to significantly slow down the disease progression to MCI or dementia.
3. To investigate the lasting duration of the intervention.

Although there is much evidence showing age-related reduction of cognitive function, many researchers point out a more optimistic viewpoint that aging is not a progressive loss. By remodeling the lifestyle, or/and monitoring the physical factors, the risk to develop dementia could be reduced. The above statements are mostly based on the epidemiological research, while it remains unclear how the aging modulates the brain changes. In previous study, the investigators have found that individuals with subjective memory complaint (SMC) showed altered brain changes in terms of resting-state connectivity when compared to those without SMC. The present study further aims to examine whether the brain function is affected by the past life experiences, such as lifestyle and physiology-related factors in SMC. More importantly, this study aims to clarify whether the lifestyle remodeling could improve SMC's cognitive function and modulate the reactivity of inflammatory factors, leading to significantly slow down the disease progression to MCI or dementia.

In summary, the present study aims to understand how the lifestyle remodeling affects SMC's brain function and biochemical indicators. Before and after the intervention, this study will use neuropsychological tests to assess all the aspects of cognitive functions, use Electroencephalogram to investigate the brain activation patterns, and use biochemical analyses to quantify the reactivity of inflammation, toxic as well as neurotrophic factors. Through the follow-up design, this study also plan to investigate the lasting duration of the intervention and the how the neural reorganization occurs as function of time.

Eligibility Criteria:
Inclusion Criteria:

1. Age over 50 years old.
2. Diagnosed with subjective memory complaint (SMC) and with lower cognitive activities and physical activities.
3. Voluntary to sign the Informed Consent Form.

Exclusion Criteria:

1. Participants or first-degree relatives diagnosed with mental diseases.
2. Participants have history of severe neurological diseases or brain injury led to loss of consciousness.
3. Participants have diagnosis of cardiovascular disease.
4. Participants have History of alcohol, Nicotine, or substance dependence.
5. Participants suffer from visual, hearing degradation (including Hearing aid user).
Achilles Tendon Repair With Bioinductive Implant

To evaluate bioinduction of new tissue and tendon healing after implantation of the Rotation Medical Bioinductive Implant used as adjunct to surgical repair in the treatment of insertional Achilles tendonitis.

This is a prospective, non-randomized, single-arm study conducted under a common protocol designed to evaluate long-term outcomes following open treatment and implantation of the Rotation Medical Bioinductive Implant to treat insertional Achilles tendinopathy.

Up to 20 subjects will be enrolled and treated with the Rotation Medical Bioinductive Implant.

Enrollment is anticipated to take up to 12 months and all subjects will be followed for two years after surgery. Therefore, the overall study duration is estimated to be 36 months.

Eligibility Criteria:
Inclusion Criteria:

1. At least 21 years of age
2. Insertional Achilles tendonitis requiring surgery that has failed conservative management, which consist of:

   A. Shoe modification B. Nonsteroidal anti-inflammatory drugs C. Physical Therapy with/without modalities
3. Chronic Achilles tendon pain lasting longer than 3 months
4. MRI or X-ray of the ankle within 60 days prior to the study procedure
5. Willing to comply with the prescribed post-operative rehabilitation program
6. Willing to be available for each protocol-required follow-up examination
7. Able to understand the informed consent process, including regulatory requirements such as HIPAA authorization, and document informed consent prior to completion of any study-related procedures
8. Ability to read, understand, and complete subject-reported outcomes in English

Exclusion Criteria:

1. Achilles tendon rupture
2. Previous Achilles tendon surgery on the index ankle
3. Genetic collagen disease
4. History of auto-immune or immunodeficiency disorders
5. History of chronic inflammatory disorders
6. Oral steroid use in last 2 months or injectable steroid use in last 4 weeks
7. History of heavy smoking (\> 1 pack per day) within last 6 months
8. Hypersensitivity to bovine-derived materials
9. Hypersensitivity to Polylactic Acid (PLA) and Polyetheretherketone (PEEK) materials
10. Metal implants, fillings, shrapnel, and/or screws
11. Females of child-bearing potential who are pregnant or plan to become pregnant during the course of the study
12. Currently involved in any injury litigation or worker's compensation claims relating to the index ankle
13. Enrolled, or plans to enroll, in another clinical trial during this study that would affect the outcomes of this study
14. History of non-compliance with medical treatment, physical therapy/rehabilitation, or clinical study participation
15. History of cognitive or mental health status that interferes with study participation
Clinical Trial of Peer Support in the ED (PCORI)

The purpose of this study is to conduct a clinical trial that tests the acceptability, fidelity, and feasibility of a peer support modified intervention for agitation management within the emergency department.

The purpose of this study is to address the increasing burden of behavioral crises and agitation in the Emergency Department (ED). There are multiple significant gaps in patient centered care for agitation management and use of restraints in the context of behavioral crises, leading to increased patient risks and reduced workplace safety. Through expanding our previous Agitation Code Team (ACT) protocol with the addition of peer support workers, we plan to develop a peer-support enhanced agitation code team (PACT). The PACT will address systems challenges experienced by staff, safety threats to ED patients with mental illness and substance abuse disorders and reduce known structural biases in marginalized patient populations during restraint/sedation decision making. Additionally, peer support workers delivery of trauma informed care is the key mechanism for mitigating bias in agitation management.

This study will build on our team's extensive experience in using a patient-centered approach for investigating best practices in management of agitation in the ED. Thus, we propose a patient centered, trauma informed, structured team-based care delivery approach through the use of a multi-level, multi-component peer-support enhanced agitation code team (PACT) intervention. PACT will address systems challenges experienced by staff, safety threats to ED patients with mental illness and substance use disorders, and known structural biases against marginalized individuals during decisions in use of restraints for behavioral crises in the ED. We hypothesize that the PACT intervention will improve patient outcomes related to behavioral crisis (i.e., reduction in use of restraints, engagement to follow-up care, decrease in repeat ED visits) and improve patient experience of behavioral acute care in the ED for patients presenting with behavioral health chief complaints, especially those from racial/ethnic minority groups and historically marginalized populations compared to usual care.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* English-speaking
* Arrives to one of the Yale-New Haven Health emergency departments (Yale-New Haven \[York Street \& St. Raphael's\], Greenwich, Bridgeport, Lawrence \& Memorial, and Westerly campuses)
* Presents with a behavioral-related chief complaint (inclusive of neurocognitive, substance use/intoxication, mental health and other behavioral related presentations) as well as additional individuals at risk of developing agitation defined via a score of \>2 on the Brøset Violence Checklist

Exclusion Criteria:

* Pregnant women, minors (\<18 years old), prisoners, and institutionalized individuals
Thermal Imaging of the Lung on a Smartphone to Differentiate Bacterial From Non Bacterial Causes of Pneumonia

This is a study of up to 275 participants from birth to 12 months who are having a chest x-ray while a patient at the Queen Elizabeth Central Hospital in Blantyre, Malawi. Participants will have thermal pictures of their chest taken by trained study staff using a Smartphone and a FLIR ONE attachment. Thermal images will be read by trained study staff to determine if bacterial pneumonia is present. Results of the thermal images will then be compared to the results of the chest X-ray. If additional images of the chest are available, additional thermal images will be taken of the same location within 24 hours of the other image.


Eligibility Criteria:
Inclusion Criteria:

* patient at Queen Elizabeth Central Hospital in Blantyre, Malawi
* having chest x-ray done to rule out pneumonia
* thermal image can be taken within 24 hours of chest x-ray
* parent/guardian provides written informed consent

Exclusion Criteria:

* none
INTERVAL Study: To Determine Whether the Interval Between Blood Donations in England Can be Safely and Acceptably Decreased

It is hypothesised that the number of donations made by English blood donors will be greater with reduced vs. standard inter-donation intervals. The null hypothesis is that there will be no difference in donations between treatment groups; this may arise if reduced inter-donation intervals result in a greater number of donation deferrals (due to low haemoglobin) and/or an unacceptable burden to donors.

50,000 blood donors will be recruited from permanent blood donation centres across England to compare different intervals between blood donations to try to find the optimum interval for which it is safe for different donors to give blood. The study will look at whether intervals should be tailored by age, gender, genetic profile, and other characteristics. Study findings should help to improve the well-being of future blood donors in England and enhance the country's blood supplies.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 years or older and fulfilling all normal criteria for blood donation
2. Willing to be assigned to any of the study intervention groups
3. Registered at one of the permanent donation clinics at the time of enrolment

Exclusion Criteria:

* As the aim of the study is to be almost "paper-less", it will involve remote web-based data collection. Hence, participants who do not have internet access and/or are not willing to provide an email address for study correspondence will be excluded.
Neurofeedback-Based Digital Therapeutics for the Diagnosis and Treatment of ADHD in Children.

A multi-center, randomized controlled trial is being conducted to investigate the efficacy of a novel digital therapeutics (DTx) program that utilizes a cross-training approach between neurofeedback training and executive function training for pediatric patients (aged 6-12) diagnosed with ADHD. This gamified interactive program is designed to improve attention deficits and executive function impairments in pediatric patients with ADHD. It is delivered through an engaging iPad game in a home-based treatment format. Patients will be randomly assigned to one of three groups: medication alone, digital therapeutics alone, or a combination of both interventions. Subjects will undergo 30 treatment sessions over the 8-week period, with each session lasting 30 minutes. Investigators will reassess symptoms of ADHD, executive functions, and objective measures of attention at the end of the treatment. Additionally, questionnaires will be distributed to parents to gather their insights and feedback on the treatment approach. This innovative digital therapeutics approach is expected to improve ADHD symptoms individually and enhance therapeutic outcomes when used alongside conventional drug treatment regimens.


Eligibility Criteria:
Inclusion Criteria:

* Meet the diagnostic criteria established by the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) for ADHD.
* Digital Cancellation Test total score\<50 points.
* Raven's Standard Progressive Matrices score≥85.
* 6 years ≤ Age\<12 years.
* No interventions for ADHD received within 4 weeks.
* No color blindness.

Exclusion Criteria:

* Patients with organic mental disorders, schizophrenia, bipolar disorder, depressive disorders, and other psychiatric conditions.
* Patients with comorbid autism spectrum disorder, Tourette's syndrome, and other neurodevelopmental disorders.
* Patients with comorbid conduct disorders.
* Patients with severe traumatic brain injury or neurological disorders.
* Patients with a history of severe somatic diseases.
* Patients with a history of substance or drug dependency.
Master Rollover Protocol for Continued Safety Assessment of Study Drug

This study is for patients who have participated in a previous study and who continue to receive benefit to have continued access to study drug and/or treatment.


Eligibility Criteria:
Inclusion Criteria:

* To be eligible patients must be currently receiving benefit in a concluded Lilly study for a compound that has opened an addendum in the continued access protocol.

Exclusion Criteria:

* Patients must not be concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
The Effect of a Pharmacist Home Visit on Drug-related Problems Post-discharge.

the purpose of this study is to determine the the effect of a home-based medication management program on drug-related problems post-discharge.

Inaccuracy of medication histories and lack of knowledge on actual medication use results in confusion about medication regimens and medication mismanagement before- during - and after hospital admission. This phenomenon accounts for many readmissions, longer duration of admission and preventable and serious Adverse Drug Events (ADEs) as a result of Drug Related Problems (DRPs). Several studies show that discharge medication reconciliation (MR) and counseling by a pharmacy employee reduces the amount of discrepancies in the discharge prescription lists. Still, no unequivocal effect of MR on the occurrence of DRPs after discharge has been shown. This is due to a shift in underlying potential harmful discrepancies from mainly patient based (unintended nonadherence) to mainly system based (eg dispensing errors) and might be explained by (1) suboptimal transfer of information (2) an overload of information during a stressful situation and (3) difficulty to implement changes in medication at home. Therefore the reduction of DRPs, improvement of patients' medication knowledge and initial adherence can probably most effectively be addressed in a multifaceted integrated transmural intervention. Repetition of important information is the key to success. Moreover, the first weeks following hospital discharge are most crucial in preventing drug-related problems as patients could slip back in old medication schemes, or new problems may arise, such as emerging ADEs due to medication changes made during hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* patient uses more than three prescribed systemic drugs intended for chronic use at admission and discharge
* patient has an expected length of stay of 48 hours or longer

Exclusion Criteria:

* Patients admitted for scheduled chemotherapy
* Patients admitted for radiation therapy
* Patients admitted for transplantation
* Patients transferred from another hospital
* Patients transferred from another non-eligible ward within the same hospital
* No informed consent signed
* A live expectancy less than 6 months
* Inability to be counselled (e.g. cognitive dysfunction, language constraints who cannot be solved with an interpreter)
* Discharge to a nursing home (presuming dependence on medication administration)
* If patients' community pharmacy is not participating in this study
Effect of Ingestion of Sugary Drinks on Thirst Sensation

The purpose of this study is to determine if regular soft drinks (with sugar) have the same effect on thirst as diet soft drinks(with sweeteners).

Participants should be in the laboratory at 8.00 in order to collect the values of weight, height, total body water, intracellular water and extracellular water in a Segmental Multi Frequency Body Composition Monitor (TANITA MC 180 MA®). Then, a blood sample will be collected for analysis of blood glucose and osmolality. They will sit at individual tables for the duration of the session and were allowed to read, listen to music with earphones, or use their portable computers with the exception of internet access to minimize visual cues (e.g., unwanted publicity for beverages or visiting Web sites showing pictures of food and drinks), which may have effect on thirst. Breakfast will be served at 9.30 on every occasion and preload stimuli will be offered exactly 60 minutes after breakfast (at 10.30). Lunch will be provided at 13.00. Motivational ratings will be first obtained at the end of collection of blood sample (baseline or time 0) and every 30 minutes thereafter until the lunch time (times 1 through 7). After lunch (time 8), participants will complete the last set of ratings and will bring a food diary to record all food and fluid intake until 00.00 that day.

Eligibility Criteria:
Inclusion Criteria:

* body mass index(BMI) between (18,5 - 25 kg/m2)
* regular consumers of breakfast
* stable in weight for the past 6 months
* not dieting to gain or lose weight
* like all drinks and food available in study

Exclusion Criteria:

* pregnant and nursing women
* smokers
* athletes
* subjects under medication(except oral contraceptives in women)
Prevalence and Impact of Sarcopenia in Patients With Inflammatory Bowel Disease

Sarcopenia is a condition characterized by significant muscle loss resulting in impaired muscle function. This condition is likely associated with a biological deviation leading to reduced reserves to withstand stressors, resulting in a poorer prognosis. The incidence of sarcopenia among patients with inflammatory bowel diseases (Ulcerative Colitis and Crohn's disease) is currently approximately 40-60%. This is likely a consequence of the preference for drug treatment over surgery, while many patients have continuous inflammation in their intestines leading to muscle loss and subsequently increased morbidity and mortality.

The purpose of the study is to identify the prevalence of sarcopenia among patients experiencing a severe flare-up of their bowel disease and to evaluate whether the removal of the colon results in improved nutritional status. Furthermore, the investigators aim to investigate whether there is a specific microbiota composition related to an unfavorable course.

The participants are longitudinally monitored with measurements taken at the flare-up/before surgery and one year afterward, including body composition, function, dietary recording, quality of life, blood tests, fecal samples, and intestinal biopsies that will be analyzed. The investigators plan to correlate body composition with a biological profile and then evaluate if there is an association. Additionally, the investigators aim to analyze if these markers are linked to different outcomes after colectomy. This study will contribute to an enhanced understanding of patients with advanced IBD and possibly change the perspective on how the clinicians should prioritize these patients for surgery. The investigators believe this study will lead to an improvement in healthcare quality and an enhanced understanding of how these disease processes function.

All examinations and laboratory tests will be conducted on two occasions. Moreover, two cohorts will be present. That is, one group where participants experiencing a severe flare-up receive medical treatment, and another group where participants with the bowel disease undergo surgery. All samples/examinations and surveys are therefore done before the operation/during the flare-up, and then again one year later during a follow-up assessment

Eligibility Criteria:
Inclusion Criteria:

* All adult patients experiencing an acute flare-up of their bowel disease (ulcerative colitis or Crohn's disease) admitted to a hospital in the Region Västra Götaland and Stockholm are invited to participate in the study.

Exclusion Criteria:

* Not wishing to participate in the study Inability to understand the language or study procedures
Cross-sectorial Use of Patient-Reported Outcomes in Chronic Degenerative Shoulder Conditions

This research project aims to test if systematic (extensive) use of patient-reported outcomes across treatment boundaries can

1. improve patients' and health professionals' understanding of individual patients' conditions and health changes,
2. improve indications for treatment,
3. strengthen patient empowerment, and
4. reduce patients' utilization of health services.

The study will be performed in the particular context of patients with chronic degenerative conditions of the shoulder. These patients are characterized by contact with numerous health professionals from different health sectors, such as general practitioner, physiotherapists and surgical referral centres, which challenges coherence and communication for the individual treatment decisions. The research project will be performed as a randomized controlled trial (RCT) with a 1-year inclusion period and two years of follow-up.


Eligibility Criteria:
Inclusion Criteria:

* shoulder pain with no acute trauma

Exclusion Criteria:

* Age \<18 years
* Non-Danish citizenship
* Unable to understand written or spoken Danish
* Inability to master electronic means of communication and/or not having an electronic communication (E-boks)
* Employee at participating centre or other relation to participating health professionals that might affect independent consent
* Psychiatric conditions, mental conditions and substance abuse that might affect the ability to provide informed consent or responding to PROMs
* Disseminated malignant condition, other serious medical conditions or other life crisis where the focus on a shoulder research project is unreasonable
* Already included in the study with the contralateral shoulder