cyrilzakka/clinical-trials huggingface dataset:
Improving Mood and Behavior in Assisted Living Residents Through Skills Training for Their Caregivers

This study will develop a treatment program to reduce mood and behavior problems in assisted living residents who have dementia.

Assisted living is rapidly becoming one of the most common methods of caring for older adults with dementia in long-term care. Over half of assisted living residents have dementia and many exhibit affective and behavioral problems related to the condition; residents' care and quality of life may suffer as a result of these problems. Despite the seriousness of this condition, interventions to teach direct care staff how to care for these residents are limited. This study will develop a program for teaching assisted living staff how to deal with the issues of patients with dementia and reduce mood and behavioral problems among this population.

Caregivers will be randomly assigned to attend skills training sessions as two 4-hour workshops, four 30 minute individual training sessions, or two 30 minute in-services. Training will focus on dementia, depression and anxiety, the incidence of behavior problems, and skills and techniques for alleviating care challenges associated with behavior problems. Caregivers will complete self-report scales and questionnaires at the beginning and at the end of the study; these measures will assess job satisfaction, reactions to resident behavioral problems, and job skills. Residents will also be recruited for this study; they will complete questionnaires about their depressive episodes, anxiety, behavioral problems, and quality of life at the beginning and at the end of the study.

Eligibility Criteria:
Inclusion Criteria for Assisted Living Staff

* Work in the assisted living residence for at least 6 months prior to study entry
* Work in the assisted living residence at least 5 days a week, for at least 4 hours a day on day or afternoon-evening shifts
* Provide direct care for at least 1 assisted living resident
* Agree to attend all training sessions and complete assessment forms
* Able to speak, read, and understand English at a 6th grade level

Inclusion Criteria for Assisted Living Residents:

* Diagnosis of dementia
* Identified by caregiving staff as having mood or behavioral problems
* Have lived at the assisted living residence for at least 3 months prior to study entry
* Have a family member with power of attorney

Exclusion Criteria for Assisted Living Residents:

* Plan to receive medication for affective or behavioral problems during the study
* History of alcohol or drug abuse
* Have attempted suicide within 1 year prior to study entry
Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer

To determine whether an accelerated course of radiotherapy delivered to the lumpectomy cavity plus margin using IORT as a single dose, intracavitary brachytherapy with the MammoSite device over 5 days, partial breast 3-D CRT in 5 days, or stereotactic APBI over 4 days is a feasible and safe alternative to a six and a half week course of whole breast radiotherapy. The study will measure both short and long-term complications of radiation treatment, short and long-term breast cosmesis, local rates of in-breast cancer recurrence, regional recurrences, distant metastases, and overall survival.


Eligibility Criteria:
Inclusion Criteria:

1. Women \>= 40 with invasive ductal carcinoma or ductal carcinoma in situ
2. Patient chooses lumpectomy rather than mastectomy as treatment for breast cancer
3. Tumor \< 2.5 cm in size, 2 mm margin of normal breast tissue between cancer and edge of specimen.

Exclusion Criteria:

1. Men
2. Prior malignancy, breast or other if metastatic or with anticipated survival of \< 5 years
3. Pregnant women
4. Immunocompromised
5. Poorly controlled insulin dependent diabetes
6. Contraindication to radiotherapy, e.g. connective tissue disorder such as scleroderma
7. Breast cancer that involves skin or chest wall
8. Multifocal or Multicentric breast cancer
9. Invasive lobular carcinoma
10. Diffuse microcalcifications on mammography
11. Invasive carcinoma with extensive intraductal component (EIC)
12. Greater than 12 weeks since definitive surgical excision or completion of chemotherapy
13. Involved lymph nodes detected by frozen section or touch preparation at time of lumpectomy
14. Patients with 1 to 3 positive lymph nodes determined postoperatively (does not include patients with micro-metastases)
15. Subglandular or submuscular breast implants (does not include patients having implants placed AFTER intra-operative radiotherapy)
Use of Serum M2BP and MSUS to Predict Arthritis in Psoriatic Patients

Aims of the study:

1. Measurement of serum level of Mac 2 binding protein among patients with psoriasis, psoriatic arthritis and subclinical psoriatic arthritis compared with healthy individuals.
2. Evaluation of MSUS findings in patients with PsA and subclinical psoriatic arthritis
3. Evaluation of the role of serum level of Mac 2 binding protein and MSUS in predicting arthritis among psoriatic patients.

Psoriasis is a quite common chronic, inflammatory immune-mediated skin disease affecting about 2% of the population . Also psoriasis is a strong risk factor for the development of several comorbidities of which the most common is psoriatic arthritis (PsA).

The presence of cutaneous psoriasis indicates a high risk for developing PsA. Studies conducted in dermatology clinics have shown a high prevalence of undiagnosed PsA in psoriasis patients , therefore identifying soluble biomarkers for PsA in psoriasis patients may help in early diagnosis, and thereby prevent disability and improve quality of life .

Mac 2 binding protein \[M2BP\] is thought to be a marker of synovial cell activation and joint destruction .M2BP may be involved in the pathogenesis of PsA .

Recently, with the introduction of new medications and wider use of musculoskeletal ultrasound (US) imaging in clinical practice, the possibility of earlier US diagnosis in patients with psoriasis in the pre-clinical phase of PsA has been examined.

Eligibility Criteria:
Inclusion Criteria:

cutaneous psoriasis Psoriatic arthritis Subclunical psoriatic arthritis

Exclusion Criteria:

any history of liver diseases non-alcoholic fatty liver, viral hepatitis, human immunodeficiency virus (HIV), autoimmune rheumatic disease other than psoriasis and PSA malignancy.
The Causative Insects in Severe Insect Sting Allergy

Study the causative insect by skin prick test and sIgE to wasp, bee and fire ants are important but false positive by crossreactivity can occur. sIgE to recombinant venom allergen is proposed to help in finding the causative insect.

Insect sting allergy from insects in Hymenoptera is not uncommon. The reaction maybe very severe and life threatening. To find the cause of insect sting allergy is important in prevention and specific treatment such as immunotherapy. The skin prick test and sIgE of these insects may have cross reactions so it is difficult to be interpreted.

The usage of sIgE recombinant venom allergen can benefit in separate cross reaction and dual allergy reaction.

Eligibility Criteria:
Inclusion Criteria:

* Cases with severe insect sting allergy reactions

Exclusion Criteria:

* Without other severe systemic diseases
* Not pregnant or lactation
Comparison of the Effects of Synchronous and Asynchronous Telerehabilitation in Patients with Juvenile Familial Mediterranean Fever

Our study will be randomized controlled. Familial Mediterranean Fever patients between the ages of 12-18 will be included in the study and will be divided into 2 groups. The first group will be applied a synchronous supervised online exercise program under the supervision of a physiotherapist, and the second group will be applied an asynchronous video-based exercise program. The exercise program will be carried out for 8 weeks, 2 days a week. There will be 3 sets, 8 repetitions in 1 set in the exercise program and will be progressed according to tolerance. In the exercise program, the synchronous group will perform the exercises with the supervision of a physiotherapist via the Zoom application, while the asynchronous video-based group will upload the exercises to the system asynchronously via a channel on YouTube that only patients can access. Feedback will be received from the asynchronous group by phone. Our exercise program will be organized with the progression of exercises such as squat, lunge, stepping, running in place and jumping. The primary outcome measures of the study are the evaluation of fatigue (VAS) and functional capacity (6-Minute Walking Test). Our secondary outcome measures are the evaluation of pain, balance, physical fitness and walking. For the assessment of fatigue: Visual Analog Scale (VAS), PedsQL Multidimensional Fatigue Scale, Fatigue Severity Scale; For the assessment of functional capacity: 6 Minute Walk Test, 30 sec Sit-to-Stand Test, 10-Step Climbing Test, Pacer aebonic fitness test, Half Squat Test; For the assessment of balance: One-Leg Stand Test, Functional Forward Reach Test, Kinvent (K-plate)-K Force measurement evaluation set, Digitsole Smart Insole System for the assessment of walking; For the assessment of physical fitness: FitnessGram test battery; For the assessment of pain: VAS will be used.


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 12-18
* The parent's willingness to have their child participate in the study
* Being diagnosed with FMF at least 6 months ago
* Being in an attack-free period
* Have an internet access
* Being able to use a computer, tablet or smartphone
* Have access to a technological device with a camera, microphone and speaker output
* Being willing to participate in the study

Exclusion Criteria:

* Having any musculoskeletal disease or orthopedic, neurological, psychological disease that may prevent participation in exercise
* Acute pain for any reason
* Development of amyloidosis
Attempted Suicide Short Intervention Program for Older Adults (ASSIP-OA): An Evaluation of a Psychosocial Intervention for Suicidal Adults Aged 65+

Older adults are sorely underrepresented in suicide prevention research, despite the fact that suicide rates are higher in this age group than in any other age group in Sweden and in many countries worldwide. There are extremely few clinical intervention studies that target this age group, with to date no published studies in Europe. The overall aim is to develop and test a modified version of the Attempted Suicide Short Intervention Program (ASSIP), which the investigators will adapt specifically for older adults (65+). The original ASSIP was developed in Switzerland where it has shown an 80% decrease in risk of new suicide attempts compared to ordinary treatment. In Sweden, ASSIP is currently being tested for persons aged 18+ . The investigators now propose a randomised controlled trial (RCT) to evaluate a modification of ASSIP specifically designed to meet the needs of suicidal persons aged 65 and above, the ASSIP-Older Adult program (ASSIP-OA).

Main study questions

1. Compared to treatment as usual (TAU), is the addition of the ASSIP-OA to ordinary treatment associated with a lower frequency of new episodes of serious suicidality (defined as either new hospitalization for serious suicidal ideation/suicide attempts or death by suicide) within 6, 12 and 24 months after the index episode?
2. Compared to TAU, do ASSIP-OA participants show better improvement in coping skills and psychological symptoms a) after the last session and b) at 6-,12- and 24- month follow-up?
3. Is a brief preventive intervention (ASSIP-OA) for older adults feasible, based on its acceptability, appropriateness, deliverability and fidelity? Do participants experience side effects?
4. What kind of challenges and opportunities do a) older adults and b) ASSIP-OA therapists experience in relation to implementing a brief preventive intervention like ASSIP-OA? Are the modifications that the investigators made in ASSIP-OA relevant for older adults?


Eligibility Criteria:
Inclusion Criteria:

1. Age 65 and above at time of index suicide attempt or hospitalisation for serious suicidal plans.
2. A mental health care contact during the active treatment period.
3. Capable of understanding study procedures and providing informed consent.

Exclusion Criteria:

1. Clinical diagnosis of dementia or MoCa score less than -2 standard deviations from the normative score for education and age (Borland et al., 2017). Ongoing delirium, or any other condition impeding the comprehension of the study's procedures and implications that hinder the provision of informed consent.
2. Severe ongoing psychosis, severe ongoing substance use disorder, emotionally instable personality syndrome. These groups are excluded as longer-term therapeutic interventions are required.
3. Terminal illness.
4. Insufficient knowledge of the Swedish language (requires interpreter).
5. Aphasia or other severe communication issue or severe hearing and/or severe visual impairment that render the intervention unfeasible despite corrective aids.
Effect of Delta-9-Tetrahydrocannabinol on the Prevention of Chronic Pain in Patients With Acute CRPS (ETIC-Study)

The purpose of this study is to determine whether application of low dose Delta9-Tetrahydrocannabinol can prevent the development of chronic pain in patients with acute CRPS.

Recent animal data suggest that the endocannabinoid system is a promising target in the prevention of chronic pain. It has been shown that the endocannabinoid system modifies excitatory and inhibitory currents in structures involved in the development of chronic pain such as the amygdala.

CRPS is a neuropathic pain condition, which is known to become chronic in a significant percentage. The study compares the effect of low dose Delta9-Tetrahydrocannabinol (90 days) and placebo in acute CRPS. All patients will receive a standard treatment consisting of drug therapy and physiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical diagnosis of acute CRPS (time from inciting event less than 16 weeks) of the upper extremity
* No risk of dependency in a psychological assessment

Exclusion Criteria:

* History of alcohol or drug abuse
* Cardiac arrhythmias
* Acute or chronic renal failure
* ASA physical status classification III or higher
* Psychiatric disorders
* Pregnancy and breast feeding
Do Patients Perceive Surgeons Who Provide Personal Information as More Trustworthy and Empathetic?

Prior studies have shown that patient trust in their physician is associated with better health outcomes and lower levels of emotional distress. Patients who have low levels of trust in their physician are less satisfied and less likely to adhere to their physician recommendations. As such, there is a need to better understand factors related to patient trust in their physician.

Purpose: To understand whether patient awareness of a surgeon's personal background improves patient trust in their surgeon.


Eligibility Criteria:
Inclusion Criteria:

* Patients (age 18 years or greater) visiting a single orthopaedic hand surgeon
* English fluency and literacy
* Ability to take informed consent
The Use of a US-measured Styloid Process of the Distal Radius EET Diameter for Prediction of ETT Size

This study will aim to test the accuracy of the ultrasonography measurement of the epiphyseal diameter of the distal radius in the prediction of the size of the cuffed and uncuffed ETT that best fits in children (1-6 years old) in comparison with the traditional age-based formulas.

Various formulas are used to predict the inner diameter (ID) of the ETT tube whether uncuffed or cuffed based on weight, age, height, and finger size. The accuracy of these formulas is questionable. These formulas depend on the child's demographic characteristics assuming that he/she has normal growth and development and cannot be applied to children with altered growth and development. Moreover, these formulas predict the ID of the ETT ignoring the tube thickness and the OD of the selected tube.

ultrasound has recently been identified as an accurate alternative to these formulas. The US-measured epiphyseal diameter of the distal radius is a method that has been recently introduced as a surrogate for the tracheal diameter. The issue is that the size of the airway can be considered a reflection of the body's growth, assuming that the growth rates of the cartilage all over the body are closely related to each other. Therefore, the measurement of the growth of the bony cartilage of the hand can be considered a surrogate marker of the tracheal diameter.9 The extent to which ultrasonography by this method can succeed in predicting the optimal pediatric ETT size remains under investigation.

Eligibility Criteria:
Inclusion Criteria:

* Weight: 10-30 kg.
* Age: 1-6 years.
* Sex: both males and females.
* ASA physical status: I-II.
* Operation: elective surgery in which airway management with an endotracheal tube is needed.

Exclusion Criteria:

* Upper airway malformations.
* Upper airway surgery.
* Active respiratory illness (cough, fever, rhinorrhea) on the day of anesthesia,
* Anticipated difficult airway.
Intraoperative Hypotension and Acute Kidney Injury After Off-pump Coronary Artery Bypass Grafting Surgery

Acute renal injury (AKI) is a common complication after cardiac surgery and is associated with worse outcomes. Hypotension is an important risk factor for the development of AKI after noncardiac surgery. However, the association between intraoperative hypotension and AKI after cardiac surgery has not been fully investigated. The purpose of this study is to analyze the association between intraoperative hypotension and acute kidney injury after off-pump coronary artery bypass surgery.

Acute renal injury (AKI) is a common complication after cardiac surgery. Cardiac surgery-associated acute kidney injury (CSA-AKI) is associated with increased in-hospital mortality, prolonged length of stay in the Intensive Care Unit and hospital, and higher costs of care. Intraoperative hypotension is an important risk factor for the development of AKI after noncardiac surgery. In a retrospective analysis, a mean arterial pressure of less than 55 mmHg predicted the occurrence of adverse cardiac- and renal-related outcomes after noncardiac surgery. Other studies also revealed that intraoperative hypotension is associated with increased incidence of AKI and 1-year mortality after noncardiac surgery. In patients undergoing cardiac surgery, 30-day mortality is proportionate to the extent of systolic blood pressure excursions outside the range of 75 to 135 mm Hg intraoperatively. However, the correlation between intraoperative hypotension and the development of AKI after cardiac surgery has not been fully investigated. The purpose of this study is to analyze the association between intraoperative hypotension and the risk of acute kidney injury after off-pump coronary artery bypass surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 50 years;
* Underwent off-pump CABG surgery.

Exclusion Criteria:

* End-stage renal disease requiring renal-replacement therapy;
* Emergency surgery;
* Kidney transplantation within 3 months;
* Missing data.
Patient Experience With OMS Procedures Regarding Anesthesia

The main purpose of the study is to know more about the experience/satisfaction of patients undergoing oral and maxillofacial surgery (OMS). Depending on the type of procedure, the patient will receive a sedation or a general anesthesia. At the first day post-operatively, patients will be contacted to complete a questionnaire. The questionnaire will be subdivided into anaesthesia-related discomfort and anaesthesia care in general.


Eligibility Criteria:
Inclusion Criteria:

* OMS procedure
* signed informed consent
* Age above 12 years

Exclusion Criteria:

* need for post-operative hospitalization
* mental disorder with no capability of filling in questionnaires
Clinical Investigation of Sorbact® Dressings

The main purpose of this exploratory clinical investigation is to study the binding of bacteria and fungi from hard-to-heal wounds to the DACC-coated dressings.

This is a prospective, open, single-centre, exploratory clinical investigation with a primary objective of studying the binding of bacteria and fungi from hard-to-heal wounds to the surface of DACC-coated dressings.

Subjects suffering from hard-to-heal wounds who are due to start using a dressing from the Sorbact range will be recruited at one investigation site in Sweden. The subjects will be divided into three groups by dressing type and there will be 10 subjects in each group, i.e., 10 subjects will be treated with Sorbact® Compress, 10 subjects will be treated with Sorbact® Gel Dressing, and 10 subjects will be treated with Sorbact® Ribbon Gauze. The dressings will be used in accordance with their respective IFU.

The clinical investigation is designed to have a treatment period of 14 days with no additional follow-up.

Three visits are planned for each subject, including a screening/baseline visit at the clinic and two further visits to the study clinic.

Eligibility Criteria:
Inclusion Criteria:

1. Able to read and understand the Subject Information and Informed Consent Form and provide meaningful informed consent
2. Due to start using one of the following dressings: Sorbact® Compress, Sorbact® Gel Dressing and Sorbact® Ribbon Gauze
3. Age ≥18 years
4. Presence of hard-to-heal wound for ≥6 weeks with no significant wound area reduction for the last 4 weeks confirmed by investigator/study nurse

Exclusion Criteria:

1. Participating in another clinical investigation
2. Known allergy or sensitivity to any components of the allocated investigational device
3. Use of systemic or topical antibiotic for the past two weeks or planning to use while participating in investigation.
4. Use of antimicrobial agent (e.g., silver- or iodine-containing dressings, or gels) during the last wo weeks
5. Use of a dressing from the Sorbact® range during the last two weeks
6. Subjects with any other condition that as judged by the investigator may make investigation procedures inappropriate