cyrilzakka/clinical-trials huggingface dataset:
The Effect of Fish Oils With Dairy or Plant Based Lipids on Mitochondrial and Physical, and Cognitive Function, in Elderly Humans

The aim of this study is to determine whether dairy or plant based fats combined with fish oils can alter skeletal muscle mitochondrial, physical, and cognitive function.

Physical and cognitive function decline as we get older and this may be due to changes within the mitochondria, organelles that regulate energy production in our cells. The ability of the mitochondria to produce energy can be affected by diet, and the composition of lipids in the cell is an important factor in determining how effective our mitochondria are. Dairy and plant based lipids differ in composition and therefore may differ in their ability to affect mitochondrial function when combined with fish oils (FO). The primary objective of this study is to determine whether supplementation with dairy or plant based fats combined with fish oils can alter skeletal muscle mitochondrial function. Additional exploratory objectives are 1) skeletal muscle and physical function and 2) cognitive function.

Eligibility Criteria:
Inclusion Criteria:

* Male or/and female;
* Caucasian;
* Age ≥ 65 years;
* BMI ≥ 20 kg/m2 ≤ 30 kg/m2;
* Normal physical activity levels: maximum of 1 hour per week engagement in structured exercise of moderate to high intensity;
* Subject should be in sufficient health to participate in the experiments, to be judged by the site-specific responsible physician, based on the subject's medical history.

Exclusion Criteria:

* Habitual smoker within the past 5 years;
* Excessive alcohol use (greater than 20g per day) and/or drug abuse;
* Subjects with diagnosed diabetes mellitus type 2;
* Significant food allergies or intolerances concerning the study products, e.g. cow's milk protein allergy
* Participation in another biomedical study possibly interfering with the study results within 1 month before the first study visit;
* Medication use e.g. antithrombotic medications known to hamper subject's safety during the study procedures;
* Subjects habitually taking fish oil supplements within 3-months of the initial study visit or habitually taking supplements that are likely to affect the main study outcomes;
* Subjects who do not want to be informed about unexpected medical findings;
* Subjects who do not want their treating physician to be informed about unexpected medical findings;
* Inability to participate and/or complete the required measurements
Residual Gastric Area and Weight Loss After Sleeve Gastrectomy

BACKGROUND: The aim of this study is to evaluate the impact of the actual size and area of the remnant stomach, as measured by Upper gastrointestinal tract radiography, on weight loss after LSG.

MATERIALS AND METHODS: From May 2017 to December 2019, 56 patients with morbid obesity were admitted to the Department of Medical and Surgical Sciences, University of Foggia and underwent laparoscopic sleeve gastrectomy.

UGI tract radiography was performed on day two after the operation to rule out leakage.

Study design and setting

From May 2017 to December 2019, 56 patients with morbid obesity were admitted to the Department of Medical and Surgical Sciences, University of Foggia and underwent laparoscopic sleeve gastrectomy. UGI tract radiography with water-soluble contrast medium was performed on the second day after the operation to rule out leakage. The radiographic images were collected through a software program called "PACS" which combined with a viewer for image processing, allows for the calculation of the residual stomach area (RSA). RSA was correlated with postoperative weight (EWL) at 1, 6, and 12 months.

Eligibility criteria

Adult patients of both genders with morbid obesity defined as BMI\>40 kg/m2 or BMI\>35 kg/m2 with at least one associated major comorbidity were included. We excluded patients with secondary obesity due to endocrine and psychological disorders, patients with previous bariatric procedures and patients unwilling to comply with postoperative diet and exercise program.

Statistical analysis

Continuous data were expressed as mean and standard deviation (SD) and they were analyzed using Student's T test. The correlation between gastric volume before and after LSG and BMI and weight loss was measured using Pearson correlation coefficient test. Correlation coefficients were classified as strong (-1.0 to -0.5 or 0.5 to 1.0), moderate (-0.5 to -0.3 or 0.3 to 0.5), and weak (-0.3 to -0.1 or 0.1 to 0.3). P\<0.05 was considered statistically significant. This work is fully compliant with the STROCSS criteria

Eligibility Criteria:
Inclusion Criteria:

* Adult patients of both genders with morbid obesity defined as BMI\>40 kg/m2
* Adult patients of both genders with morbid obesity defined as BMI\>35 kg/m2 with at least one associated major comorbidity

Exclusion Criteria:

* Patients with secondary obesity due to endocrine and psychologic disorders
* Patients whit previous bariatric procedures
* Patients unwilling to comply with postoperative diet regimen and exercise program.
Longitudinal Effect of Electroconvulsive Therapy on Schizophrenia and Bipolar Disorder: a MRI Study

For more severe and treatment-resistant cases in schizophrenia and bipolar disorder, electroconvulsive therapy (ECT) is often very effective. The purpose of this study is to investigate the brain structure and function changes after ECT treatment. The neuroimaging marker which may predict the outcome of ECT is also studied in this research.


Eligibility Criteria:
Inclusion Criteria:

* International classification of diseases (ICD) diagnosis of Schizophrenia and bipolar disorder;
* Ages 15-70
* All participants are ethnic Han
* Not received ECT treatment before
* PANSS ≥ 60 for schizophrenia subjects
* The patient's written informed consent can be obtained. If the patient is incapacitated during the onset period, the written informed consent of the legal guardian is required.

Exclusion Criteria:

* Those with mental retardation, generalized developmental disorders,delirium, dementia, memory impairment or cognitive impairment that meet the diagnostic criteria of ICD-10;
* Patients with cognitive impairment, such as Parkinson's, multiple sclerosis, stroke, and patients who meet the diagnostic criteria for ICD-10 alcohol dependence (except nicotine dependence);
* The course of the disease is very short (fast phase inversion), such as 4 or more different mood abnormalities (depression, mild mania, mania, mental illness) in one year;
* With severe unstable physical diseases; diagnosed diabetes, thyroid disease, hypertension, heart disease, etc.;
* Narrow angle glaucoma;
* With a history of epilepsy, except those with febrile seizures;
* Have or have had drug-induced malignant syndrome and severe tardive dyskinesia;
* With serious suicide attempts;
* Cannot take medication as directed by their doctors, or who do not have guardians;
* Pregnant or lactating women, or those who plan to become pregnant;
Charged Particle RT for Chordomas and Chondrosarcomas of the Base of Skull or Cervical Spine

The primary purpose of this study is to determine if the administration of a higher dose would decrease the chance of tumor recurrence, compared to the risk of tumor recurrence with a lower dose. Most of the treatment will be given protons, but participants may receive a small portion of treatment with x-rays, because less radiation is given to the skin with x-rays. This study uses two slightly different doses of radiation It is not clear at this time which of the dose levels is better.

* Participants will be assigned to a dose level by random chance, like flipping a coin.
* A treatment plan will be determined by a treatment planning CT scan and will either involve 40-44 treatments or 37-40 treatments.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven chordoma. Slides must be reviewed prior to randomization by the central review pathologist
* Sites: Intercranial (sphenoid, clivus, petrous, basio-occiput) or cervical spine
* Boost target volume less than or equal to 150
* 18 years of age or older
* Karnofsky Performance Status \> 50
* Neurologic Function of I or II
* No evidence of metastases

Exclusion Criteria:

* Previous radiation to the head or neck that would compromise the ability to deliver the prescribed treatment
* Concurrent or prior malignancy unless disease free for 5 or more years
* Evidence of metastatic disease
* Diabetes mellitus
* Major medical illness or psychiatric impairments that in the opinion of the investigator, will prevent administration or completion of the protocol therapy
Mobile Intervention for Veterans With PTSD and Anger

Anger is the mostly commonly reported reintegration concern among combat Veterans, especially those with PTSD. Problematic anger is associated with significant functional impairment. In the current project, the investigators will pilot-test a newly developed mobile app, entitled Mobile Intervention for Reducing Anger (MIRA), among Veterans with PTSD and problematic anger. The project will compare the MIRA app to a contact control condition. The investigators hypothesize that Veterans with PTSD and problematic anger will find the MIRA app acceptable and will be willing to use it to reduce their anger difficulties and improve psychosocial and occupational functioning.

Anger is the mostly commonly reported reintegration concern among combat Veterans, especially those with PTSD. Problematic anger is associated with significant functional impairment. One of the mechanisms associated with problematic anger and aggression is hostile interpretation bias, i.e., a tendency to interpret ambiguous interpersonal situations as hostile. The investigator has previously developed and piloted a computer-based interpretation bias modification intervention that successfully reduces both hostile interpretation bias and anger outcomes. In the current project, the investigators will pilot-test a mobile application version of the existing computer-based intervention, entitled Mobile Intervention for Reducing Anger (MIRA), among Veterans with PTSD and problematic anger. The project will compare the MIRA app to a contact control condition to evaluate the feasibility of recruitment, randomization, and retention procedures. The investigators will also utilize psychophysiological and electronic diary monitoring to determine whether this assessment could be used as an outcome or mechanistic variable in a subsequent randomized clinical trial application focused on evaluating the efficacy of the MIRA intervention.

Eligibility Criteria:
Inclusion Criteria:

* Veterans diagnosed with PTSD, established via the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
* Reporting a score of 12 on the 5-item Dimensions of Anger Reactions Scale
* Able to read at least 6th grade level material

Exclusion Criteria:

* Expect to be unstable on their medication regimen during the study
* Currently in a period of active psychosis or mania
* Exhibit current prominent suicidal or homicidal ideation requiring immediate intervention
* Receiving (or plan to receive) other anger management psychotherapy or trauma-focused therapy for PTSD (i.e., prolonged exposure, cognitive processing therapy during the course of the study
Transcutaneous Laser Therapy in Chronic Kidney Disease

Chronic kidney disease (CKD) affects approximately 10% of the global population, totaling over 800 million people. In Taiwan, one in eight individuals is diagnosed with CKD. According to National Health Insurance data, acute kidney injury and CKD rank first in medical expenditures, imposing a significant burden on patients' quality of life and the national healthcare system. Early intervention in CKD, especially for high-risk populations (e.g., individuals with diabetes or early-stage kidney dysfunction), can slow disease progression, delay the onset of kidney failure, and postpone the need for dialysis.

Transcutaneous venous laser therapy is a non-invasive treatment. Current literature has demonstrated that it enhances blood circulation, alters blood and erythrocyte activity, and exhibits immunomodulatory, anti-inflammatory, and vasodilatory effects on the blood. Additionally, it boosts mitochondrial activity, which is crucial as mitochondria act as the energy powerhouses of cells, providing the necessary energy for kidneys to maintain normal function.

This project aims to investigate whether this non-invasive transcutaneous venous laser therapy can reduce inflammation, improve physical activity, and further enhance patients' quality of life. It also seeks to reduce patients' medical expenses and National Health Insurance costs.


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged \>20 years diagnosed with chronic kidney disease (CKD) stages 2-5.
* Estimated glomerular filtration rate (eGFR) \< 90 ml/min/1.73m² (lasting for more than three months).
* Willing to provide routine blood test results before, during, and after each phase of the study.

Exclusion Criteria:

* Acute kidney changes within the past three months (e.g., \>30% decline in eGFR), or individuals with impaired consciousness, shortness of breath, or inability to follow instructions.
* Blood pressure exceeding 160 mmHg at the time of participation.
* Severe cardiovascular diseases (e.g., pacemaker implantation), upper limb trauma or infections, systemic lupus erythematosus, or skin cancer.
* Use of photosensitizing medications, pregnancy, or malignant tumors.
* Sensory nerve abnormalities, coagulation disorders, or the presence of kidney stones.
* Individuals with a hierarchical relationship to the study's principal investigator or team members (e.g., those from the same laboratory or having a student-mentor relationship).
Effects of Whole Body Vibration on Autonomic Function in Healthy Young and Elderly

Aging causes anatomical and physiological changes in the cardiovascular system and autonomic function with decline in its maximum function. This study aimed to evaluate the acute effects of whole body vibration on cardiovascular system, autonomic function and heart variability in healthy young and elderly. The investigators' hypothesis is that whole body vibration has different effects in young and elderly.


Eligibility Criteria:
Inclusion Criteria:

* Elderly individuals aged between 60 and 80 years
* Young individuals aged between 18 and 30 years
* Able to walk without assistance
* Good understanding to perform the proposed procedures
* Sedentary or low active

Exclusion Criteria:

* Body Mass Index (BMI) \> 35Kg/m2
* Systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg (at rest)
* Difficulty adapting to the whole body vibration
* Smoking
* Neuromuscular or degenerative disorders
* Neurological diseases
* Cardiopulmonary comorbidities
* Cardiac arrhythmias
* Osteoarticular disorders
* Use of hormone replacement therapy
* Use medications or supplements known to affect cardiovascular parameters
* Labyrinthitis
BELIDE: Better Living With Non-memory-led Dementia

Around 48 million people worldwide 1 live with dementia, of whom 3.9 million start with symptoms before the age of 65 (young-onset dementia). Most of the people presenting with young-onset dementia and some people with later onset dementia develop non-memory led dementias such as the atypical forms of Alzheimer ́s disease (AD)or frontotemporal dementia (FTD). Despite the proven benefits of educational programmes and skill training for caregivers, families of people with non-memory led dementias encounter fewer opportunities to receive this type of support. This is a significant gap in care considering that many people with young-onset non-memory led dementia are in their 50s or early 60s, which carries additional challenges about employment, financial stability, and childcare responsibilities. Finding suitable information and resources is less likely due to the lower prevalence of these phenotypes, their consequent geographical spread, and their atypical symptoms. Caregivers demands for more phenotype-specific support suggest that tailored provision of education and training is a gap in the provision of care in these types of dementia.

The aim of this study is to:

1. Determine the effectiveness of the Better Living with Non-memory Dementia educational programme for caregivers in improving psychological outcomes \[WS1\]; and
2. Conduct a mixed methods process analysis to elucidate mechanisms of change, barriers and facilitators to access and implementation as well as perceived benefits and costs \[WS2\].

The design is a randomised waiting list control trial with an 8-week intervention and 6-month follow-up comparing intervention to standard care with embedded process analysis. The intervention comprises a virtual onboarding session with a facilitator, 6 learning modules (including module-end real-life tasks to put skills into practice) and up to two further virtual check-in sessions with the facilitator. Intervention adaptation, adaptation to design and selection of primary outcome measures was based on feasibility work.


Eligibility Criteria:
Inclusion Criteria:

1. Adults (18+) who self-identify as an unpaid carer (partners, children, friends, etc.) of someone with PPA, PCA or bvFTD who is not living in a full-time care facility.
2. The care recipient must have a confirmed diagnosis of dementia (through self- report of the carer, to reflect the 'real world' application of the intervention).
3. Able to give informed consent.
4. Good comprehension of written English.
5. Access to the internet.
6. Having a minimum amount of input in the care of the person with dementia (weekly contact).

Exclusion Criteria:

1. Carers of people living with dementia in full time care facility.
2. Carers of a people with severe dementia in terms of large impact on activities of daily living. -
Resident-to-Resident Elder Mistreatment Intervention for Dementia Care in Assisted Living

Resident-to-resident elder mistreatment (R-REM) is a significant problem in long-term services and support settings (LTSS), and likely to cause physical and or psychological distress. The proposed project tests an intervention developed for use by LTSS staff. As such, it represents an important step in the process of developing approaches for ameliorating and preventing R-REM in assisted living residences which house residents with dementia and related behavioral disorders, and is thus likely to have significant public health impact.


Eligibility Criteria:
Inclusion Criteria:

* all long term residents residing at each facility at baseline, for those unable to consent, proxy consent will be sought

Exclusion Criteria:

* residents receiving hospice care,
* facilities will have the option to exclude individuals for selected reasons, (e.g., severe psychosis)
Translation of the Cerebral Palsy Quality of Life Questionnaire in Local Languages of Pakistan.

Descriptive analytical study to translate the CP-QOL into local languages of Pakistan that are, Pashto, Urdu, Punjabi, Sindhi and Balochi languages. Along with validation of the translated versions by evaluating their validity and reliability in the people of Pakistan, speaking respective languages and suffering from low back pain. No such study has been previously conducted in the Pakistan region which translates the scale and follows the proper cross-culture adaptation.

Condition or disease: Cerebral palsy. Non-probability Purposive Sampling would be used. The study will be conducted in relevant areas of Pakistan.

CP QOL has two separate forms, for both the child and the primary caregiver. CP QOL- The primary caregiver proxy report consists of 66 items for children ages 4-12 years old.

The child self-report form contains 52 items for children ages 9-12 years old. The version CP QOL-Child Self Report Questionnaire (9-12 years) is divided into areas: well-being and social acceptance, functionality, participation and physical health, emotional well-being and self-esteem, access to services and pain and impact disability.

This version should be answered by the children with CP, that is, it is the child's self-report.

All the items are rated from 1 to 9, except for one item in pain and impact of disability domain, which is rated on a 5-point scale. All responses will then be converted into scale score between 0 to 100. Higher scores meant a higher quality of life. In case children needed any help while filling out the questionnaires, they could easily consult caregivers or researchers. As the CP QOL-Child is a well-developed measurement scale, it is meaningful to validate its Urdu, Pushto, Punjabi, Sindhi and Balochi versions. It is also useful to study the QOL of children with CP in different cultural settings by using the same measurement items so that a more direct comparison can be made. Therefore, the aim of this study is to translate the CP QOL questionnaire in Urdu, Pushto, Punjabi, Sindhi and Balochi and also to assess the reliability and validity of this translated version of CP QOL questionnaire in Pakistan.

The translation and cultural adaptation processes would start after obtaining approval from the developer of the original CP QOL Child. This would be done according to WHO guidelines. Translation will be done by symmetrical category. The purpose will be to gain uniformity in the translation of tool in both the Target language and Source language. This will involve 5 steps. (Forward translation, synthesis 1, Back translation, synthesis 2 and pilot testing.) Phase 2 would be done according to the guidelines of COSMIN in which psychometric properties will be measured. (reliability, internal consistency, construct validity and factor analysis.)

Eligibility Criteria:
Inclusion Criteria:

* Children aged 9 to 12 years.

  * Children who are diagnosed with cerebral palsy.
  * Children who are able to read.

Exclusion Criteria:

* Children suffering from neurodegenerative diseases or psychiatric illness