cyrilzakka/clinical-trials huggingface dataset:
Using Virtual Reality to Treat Social Anxiety in Autistic Adolescents

This study will test the feasibility and acceptability of virtual reality assisted cognitive behavioural therapy for the treatment of social anxiety in autistic adolescents. Five adolescents will receive the intervention and a parent/caregiver of each adolescent will be asked to act as informants on some questionnaires and interviews.

Difficulties interacting with others in social situations is a core characteristic of autism spectrum disorder (ASD). These difficulties are intensified by social anxiety - commonly experienced in autistic adolescents. A promising psychological treatment is cognitive behavioural therapy (CBT), but there are constraints in its use for the autistic population. For example, CBT requires patients to imagine being in a social situation that would cause anxiety, but autistic people often experience difficulties with imagination. The use of virtual reality (VR) in CBT may help to lessen such constraints. VR uses 3D computer-generated visual environments displayed through a head-mounted display. The images are synchronised to the movements of the user such that they experience feeling immersed in the virtual scene. The virtual scene can involve social scenarios, making it an ideal tool for eliciting social anxiety in the treatment setting. The investigators can see if these virtual scenarios are indeed eliciting social anxiety by recording physiological responses (e.g. heart rate) in parallel with patients' anxiety ratings during exposure. This is important for CBT to be effective.

This study will test the feasibility and acceptability of VR-assisted CBT, combined with the use of physiological measurements, in autistic adolescents experiencing social anxiety. The therapy will typically consist of 8-20 weekly sessions and will be delivered by clinical psychologists in local mental health services. Conventional outcome measures will be used and feedback from youth and their parents/caregivers will be requested. The results of this study may lead to modification of the treatment and research methods. They will inform a later pilot randomised controlled trial.

Eligibility Criteria:
Inclusion Criteria:

Participants will be included at screening if:

* Aged between 13 and 18 years
* Clinically diagnosed with ASD by a neurodevelopmental clinician
* Experiencing anxiety in social situations that is impairing daily functioning as determined by clinicians
* Deemed suitable by the clinical team for the intervention based on factors such as sufficient verbal ability, desire to participate, willingness to undertake exposure-based activities, and no current/active suicidal plans.
* Able to speak and understand English fluently
* Patient and parents/caregivers agree to CBT

Exclusion Criteria:

Participants will be excluded at screening if:

* Diagnosed with photosensitive epilepsy
* Receiving concurrent psychological therapy
* Immediate plans are in-place to change their psychopharmacological medication regimen
SHIP-AGE: Frailty, Renal Function, and Multi-component Primary Care in Rural Mecklenburg-Western Pomerania

Chronic kidney disease (CKD) is a leading risk factor for cardiovascular and all-cause mortality among the elderly. Mecklenburg-Western Pomerania has the largest prevalence of CKD in Germany and Europe. The CKD impact in primary care strategies to reduce frailty syndrome in the elderly is unknown. For this purpose, about 820 elderly participants will be included in an observational study (MV-FIT), who will undergo an multi-factorial geriatric assessment, monitoring \& management program, specifically designed to avoid frailty. The goal of the full-scale study is to evaluate the impact of CKD in multi-component primary care strategies to reduce frailty among elderly persons in rural Mecklenburg-Western Pomerania. MV-FIT will be conducted on individuals in rural Mecklenburg-Western Pomerania, who will be observed over a period of 3 years. The Study of Health in Pomerania (SHIP) is a population-based epidemiological, two independent-cohort, study (SHIP and SHIP-TREND). SHIP cohorts have been followed for \>24 years. SHIP/SHIP TEND participants \>60 years or older will studied by a follow-up survey. The aim is to gain new insights into the development of frailty and to develop strategies for keeping those affected healthy.

Our study is a longitudinal population-based epidemiological SHIP-cohort study combined with a prospective, multi-centered, observational/interventional investigation. MV-FIT is an observational study of individuals aged 65 years or older with mGFR \>30 mL/min (n=\~820). All participants in the observational/interventional study will receive guideline-based, multi-factorial geriatric assessment, monitoring \& managements (multi-component healthcare). Subjects will be stratified by mGFR. Objectives are 1) to implement multi-component healthcare specifically comprised of components to reduce frailty and incident falls, 2) to improve compliance and adherence to the multi-component healthcare for frailty and improvement of patient welfare, ability to live independently, quality-of-life, number of falls, referrals to nursing homes, all-cause mortality in primary care of the elderly, 3) to seek the elderly individuals' experience during the course of multi-factorial primary care intervention through In-depth interviews, 4) to clarify the burden of CKD on frailty and health status, and 5) to identify novel risk factors and mechanisms for frailty and pre-frailty. MV-FIT data will be corroborated by SHIP/SHIP-TREND data.

Eligibility Criteria:
Inclusion Criteria:

* age 65 years or older
* mGFR \> 30 mL/min per 1.73 m2
* being able to understand and give written informed consent.

Exclusion Criteria:

* bedridden
* palliative
* inability to consent
* severe dementia
* inability to speak
* lack of compliance (paracusis, inability to fulfill at least 60% of the assessments)
Recording and Evaluating Preoperative Malnutrition in Electively Scheduled Adult Surgical Patients With the GLIM Criteria (GLIM-study)

Data about the prevalence of preoperative malnutrition according to all the five GLIM criteria among the broad range of surgical patients are lacking. The current study will investigate the prevalence of malnutrition according to all of the five GLIM criteria in electively planned surgical patients in a large academic hospital, the Amsterdam University Medical Centres, location AMC, where over 11.000 patients are operated on yearly.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective surgery at the operating theatres of the AUMC, location AMC
* Patients ≥ 18 years
* Dutch speaking
* Willing and able to sign consent for re-use of care data
* The study can be combined with other studies

Exclusion Criteria:

* Patients \< 18 years
* Not speaking Dutch
* Patients who do not sign consent for re-use of care data
Immunotherapy of Advanced Cancer Using a Combination Nimotuzumab and NK Cells

NK cells can persist and expand in vivo following adoptive transfer and may have a role in the treatment of late stage malignancies. NK also express an activating Fc receptor that mediates antibody-dependent cellular cytotoxicity (ADCC) and production of immune modulatory cytokines in response to antibody-coated targets. Nimotuzumab, an monoclonal antibody against EGFR (epidermal growth factor receptor), may enhance the ADCC effect of NK cell. This study will evaluate the safety of combination of nimotuzumab and NK Cell in treating advanced cancer patients. Blood samples will also be collected for research purposes.

This is a phase I clinical study of expanded NK cells from autologous origin. The NK cell will be selected and expanded ex vivo and infused back into patients. Nimotuzumab will be used 24 hours before infusion. 21 advanced cancer patients are planned to receive two cycles of NK cells and Nimotuzumab treatment. Biomarkers and immunological markers are collected and analyzed as well.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed recurrent or metastatic cancer
2. Measurable disease
3. Progressed after all standard treatment
4. ECOG performance status of 0 to 2
5. Expected life span ≥ 3 months
6. Toxicities from prior treatment has resolved. Washout period is 4 weeks for chemotherapy, and 2 weeks for targeted therapy
7. Major organs function normally
8. Women at pregnant ages should be under contraception
9. Willing and able to provide informed consent

Exclusion Criteria:

1. Other malignancy within 5 years prior to entry into the study, expect for treated non melanoma skin cancer and cervical carcinoma in situ
2. Poor vasculature
3. Disease to the central nervous system
4. Blood-borne infectious disease, eg. hepatitis B
5. History of mandatory custody because of psychosis or other psychological disease inappropriate for treatment deemed by treating physician
6. With other immune diseases, or chronic use of immunosuppressants or steroids
7. Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
8. Breastfeeding
9. Decision of unsuitableness by principal investigator or physician-in-charge
Craniosacral Therapy for Concussion Symptoms

This study investigated the utilization of CranioSacral Therapy (CST) in patients with Post-Concussion Syndrome (PCS) and capture patient-reported perceptions of their lived experiences of treatment effect upon their symptoms. The first part part was a 10 year chart review of patients who sought out CST to capture data from the medical records. The second part was an anonymous post treatment survey.


Eligibility Criteria:
Inclusion Criteria:

* Charts were extracted from a group of 212 of patients with a history of concussion to a final chart review size of 67. These patients had specifically sought of CST to address symptoms of Post Concussion Syndrome.

Exclusion Criteria:

* Was determined for the 2nd part of study: Post Treatment Outcome Survey. Final group size of 47 excluded those under age 14 and those with confounding medical or personal issues or involved in litigation.
Acupuncture in the Management of Post Operative Symptoms in Breast Cancer Patients

This study is for the woman who will have axillary (armpit) surgery as part of their breast cancer treatment. The purpose of this project is to evaluate if acupuncture is helpful to control pain and improve range of motion (arm movement). Another goal is to find out if women have an improvement in their quality of life. This study is being done in collaboration with the Oregon College of Oriental Medicine (OCOM).


Eligibility Criteria:
Inclusion Criteria:

* Female subjects
* Expected survival at least 6 months or greater
* Has had surgery with axillary dissection
* Greater than 6 nodes removed during surgery
* Greater than 21 years of age

Exclusion Criteria:

* Previous mastectomy
* Double mastectomy at the time of current axillary surgery
* Any diagnoses of autoimmune disease
* Pregnant or lactating women
* Unable to provide written informed consent
* Suspected or diagnosed fibromyalgia
* Previous shoulder injuries for the specific arm that will undergo axillary dissection
* Known or suspected drug or alcohol abuse as determined by the investigator
* Decreased range of motion (ROM) as evidenced on standard preoperative exam
* Previous acupuncture (lifetime)
Evaluation of MRI-conditional 12-lead ECG

With MRI's increasing role in detecting central nervous system and orthopedic diseases, patients with ischemic history are increasingly referred for MRI exams. Currently, 3-lead ECG gating systems are utilized during cardiac MRI scanning as standard of care. However, this monitoring system is often insufficient to evaluate for the development of important arrhythmias or ischemia during MRI scanning. Morevoer, MRI associated magnetic fields and radio frequency pulses can produce interference in the ECG signal that leads to non-diagnostic ECG signals. MiRTLE Medical, a Massachusetts-based medical device company, has developed a high-fidelity, MRI-conditional 12-lead ECG monitoring system. This 12-lead ECG system is a first of its kind that addresses the MRI-induced interference and safety issues. This study is to evaluate the efficacy of this 12-lead ECG system in the clinical setting. The investigators hope that this system will be helpful for image-guided therapeutics especially electrophysiology.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* Atrial fibrillation
* Provision of informed consent
* Eligible for the Ontario Health Insurance Plan

Exclusion Criteria:

* Failure to provide informed consent
* Pregnant women
* CMR contra-indicated
* Hemodynamically unstable
* Permanent pacemaker/ICD
* Aneurysm clip/carotid artery vascular clamp
* Claustrophobic
AZD2423 Safety and Tolerability Study in Patients With Moderate and Severe Chronic Obstructive Pulmonary Disease(COPD)

The purpose of the study is to investigate the tolerability and safety of AZD2423 in Patients with chronic obstructive pulmonary disease.


Eligibility Criteria:
Inclusion Criteria:

* Male or female of non-child bearing potential. Only women of non-child bearing potential are included in the study i.e. women who are permanently or surgically sterilised or post menopausal.
* Between 40 and 80 years of age at Visit 1
* Clinical diagnosis of COPD (GOLD stage 2 or 3)
* FEV1/FVC \<70% and FEV1 between 30 and 80% of the predicted normal post-bronchodilator (GOLD stage 2 or 3)
* Current or ex-smokers

Exclusion Criteria:

* Any clinically significant disease or disorder (including history of abnormal immune function) which, in the opinion of the Investigator, may either put the subject at risk or influence the way the drug works
* Any lung disease other than COPD, recent respiratory infections which have not resolved fully, active tuberculosis or at risk of reactivation of tuberculosis.
* Any abnormal findings in physical examination, blood or urine test results, vital signs or ECG at Visit 1 that may put the subject at risk during the study, affect their ability to take part or influence the results of the study
* Immunisation with a live vaccine within 3 months or other vaccination within 30 days before planned start of treatment
* Worsening of COPD symptoms within 4 weeks prior to start of study needing hospitalisation, oral steroids or antibiotics.
Efficacy and Safety of Pasireotide Administered Monthly in Patients With Cushing's Disease

This is a randomized, double-blind, multicenter, phase III study to evaluate the safety and efficacy of 2 dosing regiments of Pasireotide long acting release (LAR) in patients with Cushing's disease.


Eligibility Criteria:
Inclusion Criteria:

* Karnofsky performance status ≥ 60 (i.e. requires occasional assistance, but is able to care for most of their personal needs)
* For patients on medical treatment for Cushing's disease the following washout periods must be completed before screening assessments are performed

  * Inhibitors of steroidogenesis (ketoconazole, metyrapone): 1 week
  * Pituitary directed agents: Dopamine agonists (bromocriptine, cabergoline) and PPARγ agonists (rosiglitazone or pioglitazone): 4 weeks
  * Octreotide LAR, Lanreotide SR and Lanreotide autogel: 14 weeks
  * Octreotide (immediate release formulation): 1 week

Exclusion Criteria:

* Patients who are considered candidates for surgical treatment at the time of study entry
* Patients who have received pituitary irradiation within the last ten years prior to visit 1
* Patients who have had any previous pasireotide treatment
* Patients who have been treated with mitotane during the last 6 months prior to Visit 1
* Diabetic patients on antihyperglycemic medications with poor glycemic control as evidenced by HbA1c \>8%
* Patients with risk factors for torsade de pointes, i.e. patients with a baseline QTcF \>470 ms, hypokalemia, uncontrolled hypothyroidism, family history of long QT syndrome, or concomitant medications known to prolong QT interval
* Female patients who are pregnant or lactating, or are of childbearing potential (defined as all women physiologically capable of becoming pregnant) and not practicing an effective method of contraception/birth control. Sexually active males must use a condom during intercourse while taking the drug and for 2 months after the last dose of study drug and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid
Adaptation Plan for Culturally Competent Care (PAACI) in the Acute Psychiatric Unit.

This observational study aims to design, implement, and evaluate the Adaptation Plan for Culturally Competent Care (PAACI) in the Acute Psychiatric Unit of Parc de Salut Mar, Barcelona. The study focuses on improving healthcare quality for immigrant patients by reducing cultural and linguistic barriers in psychiatric care.

The PAACI program includes educational materials in multiple languages, enhanced collaboration with social services, training for healthcare professionals in cultural competence, and the use of interpretation devices. Key outcomes include reducing mechanical restraints, improving patient adherence to treatment, decreasing hospital readmissions, and increasing outpatient care engagement.

The study will analyze data from immigrant patients admitted to the Acute Psychiatric Unit one year before and after the implementation of PAACI, using various clinical and patient satisfaction indicators. This initiative aims to promote equal and equitable healthcare for diverse populations, potentially serving as a model for other mental health units.

This study evaluates the implementation of the Adaptation Plan for Culturally Competent Care (PAACI) in an Acute Psychiatric Unit. The project aims to improve psychiatric care for immigrant patients by addressing cultural and linguistic barriers.

The study follows an observational design, comparing key clinical outcomes before and after the PAACI implementation. It includes measures such as staff training in cultural competence, improved coordination with social and healthcare services, and the introduction of multilingual patient education materials.

The primary focus is on enhancing healthcare equity, reducing the use of mechanical restraints, improving patient adherence to outpatient care, and decreasing hospital readmissions. Findings from this study may inform future adaptations of culturally competent care models in psychiatric settings.

Eligibility Criteria:
Inclusion Criteria:

* immigrant patients admitted to the acute psychiatric unit
* age 18 or older
* hospitalization during the study period (12 months post-paaci implementation)

Exclusion Criteria:

* patients with severe cognitive impairment preventing informed consent
* individuals with acute medical conditions requiring transfer to another service
* refusal to participate or withdraw consent
Study to Evaluate the Safety, Pharmacokinetics and Clinical Activity of RP7214 in Combination With Azacitidine in Patients With Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia and Acute Myeloid Leukemia

This is a multi-center, open-label, non-randomized, two-part Phase I/Ib study of RP7214 in combination with azacitidine in patients with AML, MDS and CMML. Part I is a 3+3 dose-escalation study to identify the MTD/RP2D of RP7214 and azacitidine combination in patients with AML, MDS, and CMML. Part II is a dose-expansion study to evaluate the clinical activity and safety of RP7214 and azacitidine combination in AML.


Eligibility Criteria:
Inclusion Criteria:

1. Patient must sign informed consent.
2. Patient should be ≥ 18 years of age.
3. Patients who are candidates for treatment with azacitidine and present with one of the following:

   a. Part I: Dose Escalation study i. Patient with histologically or cytologically confirmed relapsed/refractory AML as per World Health Organization (WHO) classification, 2016 'OR' ii. Newly diagnosed AML patients who are ineligible for intensive induction chemotherapy due to co-morbidity or other factors 'OR' iii. Intermediate-2 or high-risk MDS according to the International Prognostic Scoring System (IPSS) 'OR' iv. Chronic Myelomonocytic Leukemia (CMML) b. Part II: Dose Expansion study i. Newly diagnosed AML patients who are ineligible for intensive induction chemotherapy due to co-morbidity or other factors.
4. Patient should have an Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2.
5. Patients must be amenable to serial bone marrow biopsies/aspirates and peripheral blood sampling as required by the protocol.

Exclusion Criteria:

1. Any cancer-directed therapy taken (e.g., chemotherapy, immunotherapy, biologic therapy or an investigational drug) within 14 days or 5 half-lives, whichever is shorter, prior to C1D1. For radiation therapy, at least 60 days should elapse from prior Total Body Irradiation (TBI) and at least 14 days from local palliative radiation therapy.
2. Patients with rapidly increasing peripheral blast counts (WBC count \> 25,000/μL) while on hydroxyurea prior to C1D1.
3. Patients with Acute Promyelocytic Leukemia (French American-British Class M3 AML).
4. Patients on immunosuppressive therapy post autologous or allogeneic stem cell transplantation (ASCT or Allo-SCT) at the time of screening, or with clinically significant Graft-Versus-Host Disease (GVHD) in the opinion of the Investigator or has not recovered from transplant-associated toxicities prior to C1D1.
5. Patient who discontinued prior therapy with DHODH inhibitors or azacitidine due to drug-related toxicity.
6. Evidence of uncontrolled/progressing infection.
7. Patients with immediate life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, and/or Disseminated Intravascular Coagulation (DIC).
8. Presence of isolated extramedullary relapse.
9. Pregnant or lactating women
Anhidrotic Area and Safety of MEDITOXIN in Healthy Male Valunteers

To determine the anhidrotic area and safety of MEDITOXIN


Eligibility Criteria:
Inclusion Criteria:

* Male adults aged between 20 and 45 years

Exclusion Criteria:

* Subjects not appropriate for participating in this study according to the investigator's opinion