cyrilzakka/clinical-trials huggingface dataset:
Cognitive Behavioral Therapy for Adherence in Patients With Type 2 Diabetes

Despite the significant relationship between depression and diabetes, there are few published studies testing the effect of cognitive behavioral therapy in improving disease outcomes among diabetics in primary healthcare settings in Egypt. The study aims at assessing the efficacy of cognitive behavioral therapy combined with diabetes education versus control receiving diabetes education alone in helping patients with Type 2 Diabetes and depressive symptoms to achieve glycemic control and compliance to treatment.

The psychological status of diabetic patients impacts their health behavior and clinical outcomes significantly. Psychological interventions are important tools to amending health behavior in Type 2 Diabetes (T2D). Cognitive Behavioral Therapy (CBT) has been an effective non-pharmacologic treatment for a wide variety of mental disorders such as depression, anxiety, post-traumatic stress disorder, eating disorders, and schizophrenia. The therapeutic approach promotes coping capabilities against difficult situations. It targets a change in negative patterns of cognition and associated behaviors and promotes emotional regulation.

Depression in diabetic patients is under-recognized. It is estimated that 44% of depressed patients are recognized by practitioners. Such lack of recognition is attributed to poor diabetic outcomes. There is a growing body of research that explores the effectiveness of this psychological technique in managing chronic physical diseases. Despite the success of CBT in managing psychiatric morbidities, research on its use in the treatment of diabetes is limited and with varying results. Moreover, the majority of studies that have investigated the burden of depression in T2D have been carried out in high-income countries, but little is done in the Middle East and North Africa (MENA) region especially Egypt.

Eligibility Criteria:
Inclusion Criteria:

* Patients meeting the American Diabetes Association (ADA) criteria for T2D (glycated hemoglobin (HbA1c) ≥6.5%, fasting glucose ≥126mg/dL) with diagnosis confirmed by the participants' medical clinicians.
* Participants aged more than 35 years; ambulatory; able to give informed consent; and able to obtain reliable information.
* Eligible patients will be screened for depressive symptoms using the Beck Depression Inventory (BDI). They will be included if they score 11-30 based on BDI (Mild mood disturbance to Moderate depression).

Exclusion Criteria:

* Participants will be excluded if they have type I diabetes and psychiatric disorders other than mood or personality disorders. Depressed patients on treatment for depression will not be included.
* Suicidal patients and those diagnosed with major depressive disorder will be referred to a psychiatrist.
Role of Ultrasound Guided Peripheral Thoracic Tumors

The aim of the study was to calculate sensitivity, and accuracy of ultrasound guided percutaneous core needle biopsy in different thoracic tumors (lung, pleural, chest wall and mediastinal).

Peripheral intrathoracic shadows are common presentation of different diseases of different origin (chest wall, pleura, pulmonary, and mediastinum), they are increasing in numbers including, peripheral lung cancer, tuberculosis, pneumonia, and atelectasis. \[1\] Thoracic masses with wall contact represent a frequent pathology that requires complex imaging studies, and often interventional procedures, in order to reach the complete diagnosis. In most cases, after a thoracic lesion is found on a thoracic X-Ray, the next step is to perform a CT and/or a bronchoscopy exam, but pleural and pulmonary lesions often call for additional investigations.

Therefore, transthoracic ultrasonography (US) permits visualization of these lesions, their structural characterization, while offering suggestive elements for their malignant nature and for the differential diagnosis.

Sonography has the capacity to clarify the nature of opaque lesions such as effusions, atelectasis, masses, and consolidations. Transthoracic ultrasound has received increased interest from chest Physicians in recent years as it has the advantages of bedside availability, absence of radiation, and guided aspiration of fluid-filled areas and solid tumors.

Furthermore US allows percutaneous guided biopsies with lower risks compared with the radiological guiding methods (fluoroscopy and CT). Trransthoracic US can replace other imaging modalities of the chest and guide a variety of diagnostic and therapeutic procedures. Under real time US guidance, the success rate of transthoracic needle aspiration or biopsy (TNB) significantly increases, whereas the risk of complications is greatly reduced.

Eligibility Criteria:
Inclusion Criteria:

1. An acoustic window for the ultrasound beam to penetrate.
2. Patients have platelet count more than 100000 and normal prothrombin time.

Exclusion Criteria:

1. Cardio vascular instability.
2. Arterio venous malformation or aneurysm.
3. Patients with uncontrolled convulsions
Digital Dance for People With Parkinson's Disease During the COVID-19 Pandemic

Dance as a treatment to support physical, cognitive and emotional functioning, has gained increased acceptance as a healthcare intervention for people with Parkinson's Disease (PD). The impact of the COVID-19 pandemic has been far reaching with devastating effects for at-risk populations. To find alternative and safe treatment delivery options during the pandemic has been of outmost importance.

This mixed-methods, feasibility study on digital for people with Parkinson's Disease aimed to investigate: (1) the feasibility and safety of a digital home-based dance intervention for people with PD; (2) change in self-reported quality of life, cognitive complaints, psychological health and fatigue; and (3) the experience of digital dance for people with PD.

Twenty-three participants partook in 10 weekly digital dance classes at home via zoom. Feasibility outcomes measures were administered at post-test. Pre-post changes in self-reported quality of life, cognitive complaints, psychological health and fatigue were measured, as well as the experience of digital dance via focus groups.


Eligibility Criteria:
Inclusion Criteria:

* Self-reported diagnosis of Parkinson's Disease
* Participant in Dance for PD at Balettakademien, Stockholm, Sweden

Exclusion Criteria:

* None
Feasibility and Colorectal Benefits of Pulses Supplementation

Beans are a forgotten staple food that shows promise in improving health. The goal of this study is to look at how bean supplementation affects metabolic and bowel health. In the long-term, the investigators believe this research will lead to a better understanding of the impact of beans on bowel health. The investigators also hope that this research study will help us understand ways to improve human diet and prevent colon cancer in the future.

Investigators are seeking adults planning for a standard of care colonoscopies (part of the participant's usual care). As part of this feeding study, a participant will be randomly assigned to either two weeks of a dry bean smoothie that the investigators will provide in addition to the participant's usual diet or continue with participant's usual diet without the bean smoothie (including the food and drink guidelines for the colonoscopy) 2 weeks before or after the participant colonoscopy.

Participants' involvement in this research will also include 2 research visits plus a visit on the day of their scheduled standard-of-care colonoscopy (each research visit will be 30-60 minutes in length, scheduled close to 2-4 weeks prior to the colonoscopy, day of the colonoscopy, as well as 2-12 weeks after the colonoscopy, depending on participant availability. The investigators expect about 25 people aged 35-75 to participate in this research.

Participation in this study will involve collecting breath tests, fecal (stool) samples, 8 Teaspoons of blood, clinical data, and participant questionnaire data. At the time of colonoscopy, the investigators will also sample the mucosa lining of the bowel and remnant (leftover or discarded) tissue from an intestine biopsy obtained as part of the participant's clinical care. Participants will be asked to sign a separate HIPAA authorization form to allow the investigators to collect information from participant's medical records. This information will become part of the research data.

Eligibility Criteria:
Inclusions:

1. 30-80 years-old
2. Overweight or obesity (body mass index ≥ 25 kg/m2)
3. Planned for a standard of care colonoscopy for colon cancer screening

Exclusions:

1. Intolerance to a bean or high bean consumer based on a screening survey
2. Pregnancy or actively planning to get pregnant
3. Any active gastrointestinal disease resulting in disturbed gut function or malabsorption (e.g., chronic diarrhea or inflammatory bowel disease)
4. Current or history of any malignancy in the past 10 years.
5. Chronic use of opioids, anti-inflammatory drugs, antibiotics, prebiotics, or probiotics within 1 month of study endpoints
6. History of a significant systemic condition (e.g., heart disease, chronic kidney disease, liver dysfunction or immune suppression), or abnormal laboratory markers (e.g., abnormal liver enzymes, creatinine, clotting factors, or low platelets count). The severity of the intolerance to fiber/ the medical conditions/lab markers and eligibility will be defined after the careful interview of the patient/review of the medical records by Dr. Hussan)
Sociodemographic Factors and Criminal Behaviour Preceding Neurodegenerative Disease - Retrospective Register Study

In this retrospective register study, clinically classified individuals with neurodegenerative disease from the years 2010-2021 will be verified from the clinical records from KUH and Oulu University Hospital (OUH). Based on the Finnish social security number, these individuals will be linked to the the national registers of Statistics Finland and Finnish Social and Health Data Permit Authority Findata including incomes, sociodemographic factors, education, occupation, criminal records as well as to the national registers including the bought pharmaceuticals, comorbidities and causes of death. For each study case, 10 randomly selected control cases, matched with age, sex and geographical area, will be used.

The aim of the study is to examine:

* 1) The prevalence of criminal and other disruptive behaviour in groups of different neurodegenerative diseases prior to and after the diagnosis
* 2) Changes in employment, residency,income, and marital status prior to and after the neurodegenerative disease diagnosis
* 3) Hospital diagnoses and reimbursable drugs prior to and after the diagnosis
* 4) Causes of death in patients with neurodegenerative disease to study excess mortality of the patients


Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of neurodegenerative disease (ICD-10) in KUH or OUH between the years 2010-2021
* Age, sex and residency matched controls (Every research patient has 10 controls matched by age, gender, and place of residency)

Exclusion Criteria:

* Patients will be divided into different diagnostic groups based on the accepted diagnostic criteria in use. If some of the formed groups contain less than 5 subjects, the disease group in question is excluded from the analyses in order to ensure the privacy protection of the subjects
Internet-based Cognitive Behavioral Therapy: a Factorial Randomized Controlled Trial About Treatment Content and Support

The purpose of this study is to investigate the differences in treatment outcomes between individually tailored and transdiagnostic internet-based cognitive behavioral therapy (ICBT), as well as the differences between weekly support by a specific therapist and weekly support by a team. The target group is adults (18 years or older) who experience mild to moderate depression symptoms, anxiety, stress or other psychological symptoms. The ICBT, in both types of treatment contents, consists of modules that the participants will work with for eight weeks in total. Participants will be recruited in Sweden with nationwide recruitment.

This study is a factorial randomized controlled trial with the aim to investigate ICBT with two kinds of treatment contents and two kinds of support. Participants will either be randomized to an individually tailored treatment, where they will be selecting their own modules that they wish to work with, or be randomized to a transdiagnostic treatment, that consists of Unified Protocol that is developed by David Barlow and colleagues. Participants will also be randomized to either get weekly support by one specific therapist or get support by "a team", meaning that the participant will get support from different therapists each week. In both kinds of support, the participant will have the opportunity to ask for support during the other times of the week as well.

Primary outcome measures are depression symptoms (measured with Beck Depression Inventory-II) and anxiety symptoms (measured with Beck Anxiety Inventory). Other, secondary, outcome measures used will for example be about stress symptoms, insomnia symptoms, and quality of life. Pre-treatment measurement, post-treatment measurement and one-year follow up is planned to be collected through an online survey.

Eligibility Criteria:
Inclusion Criteria:

* Experience mild to moderate psychological symptoms or problems
* 18 years or older
* Ability to speak, read and write in Swedish
* Have access to the internet and a smartphone, computer or other device

Exclusion Criteria:

* Severe psychiatric or somatic illness that makes participation harder or impossible
* Ongoing addiction
* Acute suicidality
* Other ongoing psychological treatment
* Recent (within the latest month) changes in the dose of psychotropic medication or planned change of dose during the treatment weeks
Work Pressure for Pharmacist With Home Pharmaceutical Care

National Health Insurance Administration, Taiwan has provided a protocol for community pharmacist to offer home pharmaceutical care for the patients with high health expenditures. Since community pharmacists need to visit patients for consultation and check their medications, it has been thought to have pressure for them in various areas. This study intends to investigate the factors related to the pressure and intention for leaving this protocol. The hypothesis are that community pharmacist who works longer, has economic pressure, and longer year of practice will have higher pressure and strong intention for leaving.


Eligibility Criteria:
Inclusion Criteria:

* community pharmacists who attend the protocol.

Exclusion Criteria:

* community pharmacists who attend any other home pharmaceutical care projects (any types).
Pharmacokinetics of Single-Dose Oral Ranolazine in Hemodialysis Patients

End-stage renal disease (ESRD) patients often develop cardiovascular complications, and cardiovascular disease is the leading cause of death in this population. Ranolazine's ability to treat angina without reducing heart rate or blood pressure makes it an important option for ESRD patients. The hemodialysis clearance of ranolazine is unknown. A single-dose pharmacokinetic study is needed to characterize ranolazine and its metabolites in ESRD patients on and off hemodialysis. Results of the proposed study will provide initial dosing estimates for a follow-up, multiple-dose pharmacokinetic study in this population.


Eligibility Criteria:
Inclusion Criteria:

* 18-74 years of age
* Within 50% of ideal body weight and greater than 40 kg
* Chronic kidney disease (CKD) stage 5 receiving maintenance hemodialysis for at least 3 months
* Native kidney estimated glomerular filtration rate(GFR) \< 10 mL/min
* No concurrent illness or evidence of infection
* Able to give informed consent

Exclusion Criteria:

* QTc interval \> 470 msec at echocardiogram (ECG) obtained within the last 6 months
* Concomitant QT-prolonging drugs, major P-gp inhibitors, and CYP3A4 inducers and inhibitors including: cyclosporine, rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, St. John's Wort, ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, saquinavir, quinidine, dofetilide, sotalol, amiodarone, erythromycin, thioridazine, ziprasidone, haloperidol, trimethoprim/sulfamethoxazole, ciprofloxacin, norfloxacin, levofloxacin, moxifloxacin
* Pre-study hemoglobin \< 9.5 g/dL
* Plasma albumin \< 2.5 g/dL
* Liver disease - exclude subjects with a Child Pugh score of C or higher
* Positive pregnancy test
* Breastfeeding
* Allergy to ranolazine
* Participating in another investigational study
* Hepatitis B infection due to dialysis isolation requirements
* Unstable blood pressure control
* Need for routine large fluid removal during dialysis (\> 4L)
Focal In-stent Restenosis After Drug-Eluting Stent

To evaluate the optimal management of focal in-stent restenosis after drug-eluting stent implantation with sirolimus-eluting implantation versus cutting balloon angioplasty

Following angiography, patients with focal DES restenosis (lesion length ≤ 10mm) with diameter stenosis \>50% by visual estimation have documented myocardial ischemia or symptoms of angina, and eligible for PCI without any exclusion criteria will be randomized 1:1 to: a) Cypher stent vs. b) Cutting balloon angioplasty. All patients will be followed for 1 year. Angiographic follow-up at 9-months is mandatory.

Eligibility Criteria:
Inclusion Criteria:

1. The patient must be at least 18 years of age.
2. Restenosis after drug-eluting stents (\>50% by visual estimate)
3. Lesion length \< 10 mm (focal ISR)
4. Patients with stable (CCS class 1 to 4) or acute coronary syndromes (unstable angina pectoris Braunwald class IB, IC, IIB, IIC, IIIB, IIIC or NSTEMI) or patients with atypical chest pain or without symptoms but having documented myocardial ischemia, amenable to stent-assisted percutaneous coronary intervention
5. The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

1. The patient has a known hypersensitivity or contraindication to any of the following medications:

   * Heparin
   * Aspirin
   * Both Clopidogrel and TIclopidine
   * Sirolimus eluting stent
   * Stainless steel and/or
   * Contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenhydramine \[e.g. rash\] may be enrolled. Patients with true anaphylaxis to prior contrast media, however, should not be enrolled).
2. Systemic (intravenous) Sirolimus use within 12 months.
3. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
4. History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
5. Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
6. Current known current platelet count \<100,000 cells/mm3 or Hgb \<10 g/dL.
7. Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
8. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
9. Patients with EF\<30%.
10. Acute MI patients within symptom onset \< 12 hours needing primary angioplasty
11. Creatinine level 3.0mg/dL or dependence on dialysis.
12. Severe hepatic dysfunction (AST and ALT 3 times upper normal reference values).
13. Patients with left main stem stenosis and left main in-stent restenosis created by DES(\>50% by visual estimate)
Functional Performance Evaluation of NU-FlexSIV Socket

The overall objective of this study is to provide a more comfortable and functional prosthetic socket for persons with transfemoral amputation that will ultimately improve their quality of life.

The proposed clinical trial will be an assessor-blinded prospective randomized cross-over trial wherein participants with unilateral transfemoral amputation will be randomized to using one of two socket conditions (i.e., sub-ischial or ischial containment) before crossing over to the other socket condition. Random allocation (computer-generated) utilizing blocks of random size will be used to assign the initial treatment condition. The trial will be balanced such that all subjects will receive all treatments (i.e., both socket conditions) and that all subjects will participate for the same number of periods (i.e., two). While a washout period is not strictly necessary, it is effectively included as subjects will need to transition back to their usual, pre-study socket/prosthesis while the second test socket is fabricated.

Allocation of intervention will be concealed from the investigators until after a subject is enrolled. The starting socket design will be enclosed in sequentially numbered, opaque, sealed envelopes. Envelopes will be opened sequentially and only after the participant's name and other details are written on the appropriate envelope.

Blinding of prosthetic interventions is challenging given that they are devices that must be custom-fabricated and donned each day by the subject. Hence, for this study only the assessor will be blinded. The blinded assessor will be responsible for administration of the clinical performance and patient-reported measures as well as processing of motion analysis data.

Eligibility Criteria:
Inclusion Criteria:

* unilateral transfemoral amputation
* have used a prosthesis for two or more years
* have a residual limb that is stable in volume and free from wounds
* be physically fit enough to participate in the performance tests (Medicare Functional Classification Level K3 or K4)
* have no previous experience of the sub-ischial socket
* able to complete all visits for the duration of the protocol

Exclusion Criteria:

* have a residual limb femur of less than 5-inches
* co-morbidities that affect function, including neurologic abnormalities (e.g. neuropathic pain that would interfere with the study)
* do not speak and read English
Internet-delivered Cognitive Behaviour Therapy for Older Adults With Anxiety

The purpose of this study is to determine whether tailored internet-administrated cognitive behaviour therapy (ICBT) is a feasible approach in the treatment of anxiety symptoms and comorbid depressive symptoms in older adults.


Eligibility Criteria:
Inclusion Criteria:

* Have anxiety symptoms

Exclusion Criteria:

* Suicidal ideation
* Alcohol addiction
* Other major primary psychiatric disorder
* Ongoing psychological treatment