cyrilzakka/clinical-trials huggingface dataset:
Acceptance and Commitment Therapy-based Intervention for Loneliness Among Older Adults Living Alone

The proposed cluster-randomised wait-list-controlled trial will (1) examine the effects of the acceptance and commitment therapy (ACT)-based intervention on loneliness, psychological flexibility, psychological distress, health-related quality of life, and healthcare utilisation among older adults living alone in Hong Kong; (2) investigate whether the effect of the ACT-based intervention on loneliness is mediated through psychological flexibility; and (3) explore the experiences and perceptions of older adults living alone who participate in ACT-based interventions, including their perceptions of the intervention's impact on their loneliness.

A convenience sample of 234 older adults living alone will be recruited from six participating community centres (39 participants from each centre). Eligible older adults will be randomly assigned to a waitlist control group (n = 117) or an intervention group (n = 117). Both groups will receive usual community support services. The intervention group will additionally receive four weekly face-to-face ACT-based intervention sessions (approximately 90 minutes each) in group format (each group consisting of six to eight older adults).

The primary outcome (loneliness) and secondary outcomes (psychological flexibility, psychological distress, health-related quality of life, and healthcare utilisation) will be assessed at baseline (T0), immediately post-intervention (T1), 3 months post-intervention (T2) and 6 months post-intervention (T3), using validated questionnaires. A purposive subsample of 36 intervention group participants will be invited for focus group interviews. A generalised estimating equation model with intention-to-treat and path analyses will be used to analyse the quantitative data, whereas thematic analysis will be used for the qualitative data.

Eligibility Criteria:
Inclusion Criteria:

* older adults aged 60 years or above
* residing in the community (living at home without being institutionalised in the past 6 months)
* capable of speaking and understanding Chinese
* experiencing loneliness (scoring ≥3 on a three-item loneliness screening scale)
* living alone for more than 1 year

Exclusion Criteria:

* currently undergoing psychological intervention
* having a clinical diagnosis of mental illness
* being cognitively impaired (Abbreviated Mental Test score \<6)
* having visual/language/communication difficulties
RISI in the Treatment of Recurrent Chest Wall Malignancies After EBRT

This study will observe the efficacy and toxicities of 3-dimensional printing noncoplanar template assisted CT guided radioactive iodine-125 seeds implantation in the treatment of patients with recurrent chest wall malignancies after external beam radiotherapy prospectively, and analyzes the influence of clinical and dosimetric factors on the outcomes.

Radioactive Iodine-125 seed brachytherapy is a conventional treatment in Peking University Third Hospital. Radioactive Iodine-125 seed brachytherapy is the implantation of Iodine-125 seed into tumors.The radioactive Iodine-125 seed can release low dose of irradiation persistently which kills tumors cell and causes less damage to normal tissue at the same time. This study will enroll the patients with recurrent chest wall malignancies after external beam radiotherapy (primary or metastasis) who underwent CT-guided radioactive iodine-125 seed implantation assisted by 3D-printing template from 2019 to 2021. The investigators evaluate the dose that covers 90% target volume(D90) and other parameters after the implantation. The efficacy and adverse events will be observed. Local control(LC) time and overall survival(OS) time are evaluated.

Eligibility Criteria:
Inclusion Criteria:

* histological proven malignant tumor
* tumor located in chest wall and lesion diameter \<= 10 cm
* recurrence after external beam radiotherapy
* there is no bleeding tendency
* there are no serious or uncontrolled underlying diseases (such as severe or uncontrolled hypertension, diabetes, cardiovascular and cerebrovascular diseases, and/or organ dysfunction
* there is an appropriate puncture path which is expected to achieve the treatment dose
* KPS \> 70, which is expected to be able to tolerate puncture/ brachytherapy, and the expected survival time is longer than 3 months

Exclusion Criteria:

* there are skin ulceration, or with high risk of skin infection and ulceration
* liquefaction and necrosis in a large area in tumor with poor expected seeds distribution
* pregnant women, lactating women, psychiatric patients
* patients with poor compliance can not complete the treatment
* patients that researchers considered inappropriate to participate in this clinical trial
Counseling Among Gender Diverse Adolescents Who Use Depot Medroxyprogesterone

Recommendations regarding contraceptive counseling and reproductive health differ amongst transgender and gender diverse (TGD) youth compared to cis-gender youth. Limited existing literature demonstrates the need for contraceptive counseling that moves beyond cis- and heteronormative assumptions that start with pregnancy prevention and address concerns at the intersection of gender identity.

The Investigator's qualitative study will focus on creating best practices regarding equitable contraceptive counseling for TGD youth. The Investigator will recruit transgender youth who are assigned female at birth, and currently or interested in using depo medroxyprogesterone (DMPA). Through focus groups and semi-structured interviews, the investigator hopes to guide providers in creating best practices and more equitable contraceptive counseling for TGD youth and measure satisfaction of DMPA in TGD youth.

Recommendations regarding contraceptive counseling and reproductive health differ amongst transgender and gender diverse (TGD) youth compared to cis-gender youth. TGD youth face unique health disparities including increased risk of sexually transmitted infections, sexual abuse and violence, and unwanted pregnancies. TGD youth also face inequities within the healthcare system including lack of access to providers and delay or avoidance of care. Both patients and providers also have misconceptions around pregnancy risk in transgender individuals assigned female at birth (AFAB) who are sexually active with people assigned male at birth. Limited existing literature demonstrates the need for contraceptive counseling that moves beyond cis- and heteronormative assumptions that start with pregnancy prevention and address concerns at the intersection of gender identity.

The Investigator's qualitative study will focus on creating best practices regarding equitable contraceptive counseling for TGD youth. The Investigator will recruit transgender youth who are AFAB, and currently or interested in using depo medroxyprogesterone (DMPA). Through focus groups and semi-structured interviews, the investigator hopes to gain the perspectives of and experiences of TGD youth with self-and clinic- administered DMPA. The investigator hopes the results of this study can guide providers in creating best practices and more equitable contraceptive counseling and measure to satisfaction of DMPA for TGD youth.

Eligibility Criteria:
Inclusion Criteria:

* between the ages of 15-21,
* currently receiving care at one of the clinic sites, assigned female at birth, identify as transgender or gender diverse , and are currently using or are interested in using DMPA.

Exclusion Criteria:

* Any contraindications to DMPA (based on any category 3 or 4 recommendations from the CDC MEC guidelines)
Prospective Multicenter Study for Early Evaluation of Acute Chest Pain

In this study, clinical database and blood sample bank of acute chest pain (ACP) will be established at chest pain center of multi-center hospital. To explore new biomarkers and screen clinical indicators with effective risk stratification and prognostic evaluation for ACP through proteomics technology and statistics methods. Risk stratification and short-term and long-term prognostic evaluation models for high-risk ACP will be established using large data analysis.

In this study, acute chest pain (ACP) patients will be selected from chest pain center of nine large tertiary hospitals in China from November 1, 2019 to October 31, 2021. All the selected patients will sign the informed consent.

Patients' characteristics, the first vital signs at the time of consultation, the first arterial blood gas, complete blood count, coagulation markers, blood biochemical results and myocardial injury markers, imaging examinations and electrocardiogram will be collected within 30 minutes at admission. Meanwhile, whole blood and plasma samples will be collected and stored in - 80 ℃ refrigerator. After diagnosis according to the gold standard examination or related guidelines, patients will be admitted to different department for standard treatment. Medication, surgical procedures and complications will be recorded carefully. Plasma and whole blood will be used to detect proteomics and/or genomics biomarkers associated with early evaluation of ACP.

Screening early evaluation indicators using novel protein biomarkers and easy-to-obtain clinical indicators, and establishing evaluation models for high-risk ACP by data analysis methods. Area under the receiver operating characteristic curves (AUROC), net reclassification improvement (NRI), integrated discrimination improvement (IDI) and decision curve analysis (DCA) will be used to evaluate the prediction ability of the model.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18-90 years old;
* The time from onset of symptoms to emergency room is less than 24 hours.

Exclusion Criteria:

* Patients complicate with end-stage neoplastic diseases;
* Pregnant women;
* Patients re-visit during the selection period;
* Patients refuse to participate in this study.
Comparison of Different Training Programs on Cognitive Function

The goal of the project is to identify the most effective exercise modalities in terms of neuroprotective effects and FP improvement.

Hypothesis: Dancing will increase BDNF, GDNF and CLU levels to a greater extent than traditional forms of AF, resulting in significantly greater improvements in FP in subjects aged ≥ 60 years. The study will involve 60 women aged ≥ 60 years, randomly and equitably assigned to training groups (i.e., resistance training using body weight, dance) and a control group (i.e., a group of physically inactive women).

Methodology:

Participants: 60 women aged ≥ 60 randomly and equally assigned to training groups (Dance and Resistance training) and a control group (i.e., physically inactive women)

Scientists will compare the impact of different forms of physical activity on cognitive functions

The training interventions will last 6 months. The intensity of physical activity will be determined as a percentage of maximum heart rate (HRmax), assessed based on a fitness test (Chester Step Test), using data from mobile devices monitoring physical activity. Cognitive function (CF) levels, and the concentrations of GDNF, BDNF, and CLU, as well as the Chester Step Test, will be evaluated twice: once at baseline and once after the training programs. Blood samples for measuring neurotrophin and CLU levels will be collected in the morning, after an overnight fast (approximately 12 hours since the last meal). The concentrations of neurotrophins and CLU will be measured using the ELISA method. CF will be assessed using standardized and validated neuropsychological tests.

Expected Outcomes: Greater improvement in CF in the dance group compared to the resistance training and control groups, with higher levels of BDNF, GDNF, and CLU in the dance group.

Eligibility Criteria:
Inclusion Criteria:

* women

Exclusion Criteria:

* previous diagnoses of cardiovascular diseases
The Clinical and Hemodynamic Course of Cardiogenic Shocks Hospitalized in Critical Care

Cardiogenic shock is a frequent reason for hospitalization in critical care units, with high mortality (50%). Several French registries have been created to improve knowledge of the prognostic factors of cardiogenic shock. In recent years, temporary mechanical circulatory support has become more important in cardiogenic shock. The monitoring of catecholamines is also performed with a global score: the vaso-inotropic score. The purpose of our study is to consider using these new data and techniques to create a cohort of cardiogenic shock within our critical care unit.

This observational study is based on clinical, biological, and hemodynamic data recorded during the ICU stay of patients for cardiogenic shock.

The primary endpoint is the relationship between the hemodynamic evolution of cardiogenic shock and in-hospital mortality.


Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized in ICU for cardiogenic shock
* Patient with cardiogenic shock as defined by the FRENSCHOCK2 study criteria

Exclusion Criteria:

* Patient with cardiogenic shock in the context of septic shock and hemorrhagic shock
Effects of Virtual Reality on Cerebral Palsy

Virtual reality (VR), is one of the most popular approaches to Cerebral Palsy (CP) rehabilitation and has been used in rehabilitation field for 30 years. VR is provided via a computer or a game console, and players interact with real-like objects . Using a VR interface as a rehabilitation tool increases the fun received by the client which, in turn, increases the participation of the client to the rehabilitation sessions.

This is a study that focused on long-term effects of Virtual reality (VR) intervention on motor skills and activities of daily living (ADL) independence of children with CP.


Eligibility Criteria:
Inclusion Criteria:

* had to be 7 to 12 years-old,
* to be diagnosed with CP,
* to get 1 or 2 from Gross Motor Functioning Classification System,
* to get a score of 1 to 3 from Manual Ability Classification System,
* to score at least 23 from Mini Mental State Examination - children edition,
* to be able to follow verbal instructions, and
* to have the

Exclusion Criteria:

* having any surgical operation and/or botulinum toxin injection in last 6 months,
* having any visual and hearing diseases that may affect using VR, and
* participating in any other rehabilitation programs (such as physiotherapy, speech therapy, psychotherapy etc.),
* having ataxic and/or dyskinetic symptoms.
Sensitivity and Specificity of a Mobile Lead-one ECG Like Device for the Detection of Atrial Fibrillation (AF)

Atrial Fibrillation(AF) is one of the most common abnormal heart rhythms and approximately 3% of the general population have AF. The prevalence increases with age of the population and is increased in people with diabetes, hypertension and those who are overweight. AF is a major risk factor for stroke; people with AF are five times more likely to suffer an ischaemic stroke; however this can be reduced significantly with appropriate interventions which depends on detection of the abnormal rhythm. Although the National Institute of Health and Care Excellence (NICE) currently recommends screening patients with symptoms of AF, including syncope, heart palpitations, and chest discomfort, as well as patients who have suffered a stroke or heart attack, many patients remain symptomless and are not managed for their increased stroke risk. Guidelines for AF screening include manual palpation of a peripheral pulse, followed up by an ECG for patients who have an irregular pulse. Although almost all patients with AF have an irregular pulse, only about 12 in 100 patients with an irregular pulse have AF. Use of an improved screening tool for AF could both cut down the number of people undergoing unnecessary ECGs, and also lead the way for a wider screening programme for AF. The aim of this study is to investigate the sensitivity and specificity of a new ECG like device for the detection of AF, the Plessey imPulse. Participants referred or admitted to secondary care with stroke symptoms and other indicators of increased prevalence of AF will be recruited. Participants will undergo three methods of AF screening, a peripheral pulse, a lead-one like ECG using the imPulse device, and the gold-standard for AF detection, a 12-lead ECG. By comparing to the ECG results specificity and sensitivity will be established for both methods in this population.


Eligibility Criteria:
Inclusion Criteria:

Patients with AF or suspected AF referred or admitted to hospital (secondary care setting). Able to hold the impulse device with both hands. Able to give informed consent.

Exclusion Criteria:

Patients who are unable to give informed consent either through lack of capacity or lack of ability to understand study documentation. Patients who are unable to hold the impulse device for 2mins. Presence of artificial pacemaker or cardioverter defibrillator.
VEGF Imaging in Renal Cell Carcinoma

The primary objective of the study is to evaluate the feasibility of 89Zr-bevacizumab PET imaging as a biomarker before and during treatment with sunitinib or bevacizumab plus interferon in patients with RCC. 89Zr-bevacizumab PET imaging will be regarded a promising biomarker if the target for treatment (VEGF) can be visualised and if uptake changes after institution of treatment.

* To explore if 89Zr-bevacizumab PET imaging can differentiate RCC patients with progressive disease from patients with non-progressive disease during treatment with sunitinib or bevacizumab plus interferon.
* To explore relationships between VEGF pathway related biomarkers and 89Zr-bevacizumab PET response.
* To explore effect of 2 weeks off treatment in the sunitinib arm on pharmacodynamic biomarkers and 89Zr-bevacizumab PET response.

Eligibility Criteria:
Inclusion criteria:

* locally advanced irresectable or metastatic renal cell cancer
* no untreated brain metastases (CT or MRI not necessary in the absence of symptoms)
* no uncontrolled hypertension
* no clinically significant cardiovascular events or disease during the last 12 months
* no surgery in the last 4 weeks
* no treatment with bevacizumab or another monoclonal antibody with anti-angiogenic properties in the last 4 months
* no treatment with a tyrosine kinase inhibitor during the last 4 weeks
* measurable disease with x-ray or CT scan, at least one site of disease must be unidimensionally measurable as follows: X-ray \> 20 mm, Spiral CT scan \> 10 mm, non-spiral CT scan \> 20 mm
* clear cell histology component
* not pregnant or nursing
* women of childbearing potential must use effective contraception
* absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
* before patient randomization, written informed consent must be given according to GCP, and local regulations
First CORRECT Study of Minimal Residual Disease (MRD) Detection in Colorectal Cancer

The CORRECT - MRD I study will prospectively enroll patients who have undergone complete surgical resection for stage II or III colorectal cancer. Patients will be followed for up to 5 years for recurrence.


Eligibility Criteria:
Inclusion Criteria:

Subject is/has:

1. 18 years of age or older.
2. Diagnosis of carcinoma of the colon or rectum (patients with lymphomatous, sarcomatous,or neuroendocrine features are not eligible).
3. Post complete surgical resection of CRC, with last surgery occurring within 180 days prior to enrollment are eligible if all of the following conditions are met:

   1. in the opinion of the surgeon, all grossly visible tumor was completely resected ("curative resection") and
   2. histologic evaluation by the pathologist confirms the margins of the resected specimens are not involved by malignant cells.

   i. Patients with T4 tumors that have involved an adjacent structure (e.g., bladder, small intestine, ovary, etc.) by direct extension form the primary tumor must have had all or a portion of the adjacent structure removed en bloc with the primary tumor and local radiation therapy will not be utilized.
4. Pathologic Stage II or III CRC.
5. ECOG performance status ≤ 2 (0, 1 or 2).
6. Able to understand and provide written informed consent.
7. Willing and able to comply with the study requirements, which includes the collection of approximately 35mL of blood for each research blood draw.

Exclusion Criteria:

Subject is/has:

1. Initiated adjuvant therapy for current CRC diagnosis (note: neoadjuvant therapy acceptable).
2. Known pregnancy or breastfeeding at time of enrollment.
3. Prior history of any invasive cancer (including CRC) within the past 3 years prior to informed consent, with the exception of non-melanoma skin cancer. Patients with a prior history of noninvasive (in situ) carcinomas may participate after definitive treatment.
4. Prior transplant history:

   1. Prior allogeneic hematopoietic stem cell transplant at any time.
   2. Prior solid organ transplant within the last 2 years prior to enrollment.
5. Multiple cancer diagnoses: Synchronous or asynchronous diagnoses (or suspicion) of multiple primary cancers at the time of eligibility screening.
Spot Depression Study

This study aims to identify signs of depression and bipolar disorder by measuring changes of certain molecules (biomarkers) that can be detected in dried blood spots. Our goal is to use these biomarkers to develop a diagnostic test to enable early treatment, which can lead to better patient outcomes.

Bipolar disorder and major depression are serious mental health conditions that have a devastating impact on patients, their families and friends, and society. Currently, no laboratory test exists for these disorders. We are trying to develop a molecular test based on blood spots (small spots of blood obtained from patients' fingertips that have been dried on special paper). Volunteers take part by filling out the questionnaire at www.spot-depression.org. They may then be selected to provide a dried blood spot, which can be collected at home using a kit that will be mailed to their address.

Eligibility Criteria:
Inclusion Criteria:

* Residing in the United Kingdom
* Over 18 years of age

Exclusion Criteria:

* Pregnant or breastfeeding
* Presence of blood-borne infection
Effect of Probiotic Bacteria on Oral Candida in Frail Elderly

The aim of this study is to investigate the effect of daily intake of the probiotic Lactobacillus Reuteri on the prevalence and counts of oral Candida in frail elderly living in nursery homes.

The aim of the present study was to investigate the effect of a twice daily intake of lozenges containing probiotic Lactobacillus reuteri on the prevalence and counts of oral Candida in senior residents living in nursery homes. The material consists of 215 elderly persons (range 60 to 102 years) living in 20 different nursery homes in the County of Kronoberg, situated in the southern parts of Sweden. The subjects were consecutively enrolled after informed consent consisting of verbal and written information directed to the individual as well as to their relatives. The study employed a double-blind randomized placebo-controlled design.

Eligibility Criteria:
Inclusion Criteria:

* non-smoking
* ability to cooperate with a dental examination and saliva sampling

Exclusion Criteria:

* severe chronic disease, malignancies or ongoing medication with immunosuppressive drugs
* severe dementia or cognitive impairment