cyrilzakka/clinical-trials huggingface dataset:
Family Cancer Caregivers Receiving a Specific Supportive Care Intervention Pre- and Postloss

Background and study aims The effect of cancer caregiving may have profound impact on the psychosocial health of family caregivers and become evident after loss. Grief following the loss of a close relative is one of the most emotional challenging experience faced by family caregivers. Providing a family based intervention before and after a close relatives´death may positively impact bereavement outcomes. This study aims to assess the impact of a continuing specific supportive care intervention on bereaved family caregivers grief response scores and psychological distress following the loss of a close relative when offered before and after death because of cancer.

This clinical trial is part of a broader research study (registered trial intervention ISRCTN21786830) which aimed to evaluate a palliative care nurse-led family-oriented intervention Family-Strengths Oriented Therapeutic Conversation (FAM-SOTC) to support family caregivers of a close relative with advanced/final stage cancer, in the context of the family when receiving specialized palliative home-care. The purpose of the current trial is to investigate the effects of the FAM-SOTC intervention when additionally delivering the third session of the intervention in this trial; an adapted version; FAM-SOTC Post-Loss and repeated post-intervention measures at 3, 5 and six months post-loss completed by bereaved family caregivers who have prior participated in the FAM-SOTC trial intervention pre-loss are compared to measures at 3, 5 and six months post-loss among bereaved family caregivers in a control group who received usual care pre- and post-loss from the palliative home-care unit. The FAM-SOTC intervention and the FAM-SOTC Post Loss intervention is delivered simultaneously in two separate clinical trials, where two sessions were delivered pre-loss (FAM-SOTC) and one session delivered post-loss (FAM-SOTC-PL).

Eligibility Criteria:
Inclusion Criteria:

* The eligibility criteria is that the primary family caregivers (who had been identified by the patient pre-death) are aged 18 years or older, bereaved due to cancer and that three months have passed since the deceased has died. Additional inclusion criteria is that the family caregivers have received care from a specialised palliative home-care unit at a university hospital in the advanced and final stage of their close relatives´ cancer trajectory.

Exclusion Criteria:

* Non cancer and not being participating in another family level psycho-social intervention research.
Helping Others Toward Positive Emotions in People With Heart Failure

Heart failure (HF) affects 5 million people in the US and is the most common cause of hospitalization in elderly adults. One-third of patients who are hospitalized with HF have major depression. Depressed HF patients have double the rates of morbidity and/or mortality and worse health-related quality of life than non-depressed HF patients. The investigators previous pilot research suggests that a brief Cognitive Therapy (CT) intervention may improve short-term cardiac survival among depressed hospitalized HF patients compared to non-depressed HF patients who received usual care. Therefore, the investigators will conduct a larger study to evaluate the effects of the intervention on longer cardiac event-free survival, symptoms of depression, health-related quality of life, and stress levels in patients with HF. The investigators hypothesize that patients in the intervention group will experience longer cardiac event-free survival, lower levels of depressive symptom, better health-related quality of life, and lower salivary cortisol levels at follow-up than patients who receive usual care.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to the hospital with a primary or secondary diagnosis of congestive heart failure OR admitted to the hospital for cardiac reasons and has a history of chronic heart failure
* American College of Cardiology/ American Heart Association Stage C HF
* 21 years or older

Exclusion Criteria:

* Co-existing terminal illness likely to be fatal within the next 12 months
* End-stage HF (defined as American College of Cardiology Stage D HF)
* Cognitive impairment that precludes the ability to give informed consent
* Active suicidality (defined choosing option 1, 2 or 3 on Item 9 of the PHQ-9)
* History of the death of a spouse or child within the past month
* History of psychotic illness or bipolar illness
* Current alcohol dependence or other substance abuse
* Non-English speaking or possessing any other communication barrier
Ocular Adaptation and Visual Performance for Accommodative Contact Lens

Presbyopes (people who might have a significant loss of their ability to accommodate their crystalline lens in the eye) will be recruited to wear a test lens and perform typical clinical tests of visual acuity with different luminance levels and viewing distances/angles.

In the proposed study we plan to recruit presbyopes (people who might have a significant loss of their ability to accommodate their crystalline lens in the eye) to wear a test lens and perform typical clinical tests of visual acuity with different luminance levels and viewing distances/angles. These are similar to the typical examinations conducted for regular contact lens wearers. Results of this testing will be used to evaluate the efficacy of test lenses and to provide additional information for revision of test lenses. If shown to provide adequate eye comfort and intended vision correction, this lens design has the potential of allowing tens of millions of presbyopes to adapt to contact lenses and significantly improve their vision and well-being.

Eligibility Criteria:
Inclusion Criteria:

* Be between 40 and 65 years of age.
* Have normal/corrected-to-normal monocular acuity of better than 20/25 for both eyes.
* Have pupil diameter in regular lighting ≥ 2.5 mm.
* Willing and able to wear multifocal contact lenses in both eyes.
* Have a current optical prescription (obtained less than 2 years ago).
* Have spherical equivalent correction equal to or higher than -1.00 Diopter and equal to or less than +0.50 Diopter.
* Have cylindrical correction equal to less than 0.50 Diopter.

Exclusion Criteria:

* Have no prismatic correction.
* Without any eye infection, inflammation, disease, or abnormality that contraindicates contact lens wear within the past 6 months.
* No clinically significant ocular pathology (e.g., cataract, keratoconus, dry eye, diabetic retinopathy, or age-related macular degeneration)
* Have no photosensitive disorders, including migraine and seizure.
* Have no binocular dysfunction, including amblyopia, strabismus, and other binocular diseases.
Evaluation of the Cardioprotective Effect of L-carnitine and Silymarin in Patients Receiving Anthracycline Chemotherapy

the study aim to protect patients received anthracyclines containing chemotherapy from cardiotoxcity induced by anthracyclines derivatives. by using L-carnitine and Silymarin for protection the heart from anthracyclines toxicities, and in addition its a comparitive study between L-carnitine and Silymarin.

Aim: Anthracycline induced cardiotoxicity is the most common constrains of its use in treatment of various types of cancer. This study aimed to investigate benefits from adding L-carnitine and Silymarin compared to anthracycline chemotherapy alone in patients with cancer.

Methods: 83 patients were recruited from Clinical Oncology Department, Tanta University, Egypt, then prospectively randomized to receive their anthracycline containing therapeutic regimen, control group (n=33) or anthracycline plus L-carnitine, L-carnitine group (n=25), or anthracycline plus Silymarin, Silymarin group (n= 25). Blood samples were collected at begging and after 6 months to measure LDH, CK-MB, cTn I, Anticardiolipin IgG, Fe, ferritin and TIBC and % of saturation. % EF was documented. Data were statistically analyzed by ANOVA and paired t test. P \<0.05 was statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* cancer patients receiving anthracycline chemotherapy in their protocol alone (without any cardioprotective agent),
* aged 20-60 and
* female patients were included.

Exclusion Criteria:

* patients with a history of heart failure, arrhythmia, history of cardiac catheterizations or, history of angina, uncontrolled hypertension and uncontrolled diabetes,
* patients with impaired liver function tests,
* previous anthracycline-containing regimens and any cardiotoxic chemotherapy regimens,
* previous history of chest wall irradiation.
* Brain metastasis,
* pregnant patients and
* patients who refused informed consent,
Unified Barlow Protocol (UP) in Cancer Survivors for Cognitive Impairments

Background: Cognitive impairment appears frequently in cancer survivors, negatively affecting the quality of life and emotional well-being of patients. This study compares the effectiveness of a well-established treatment (cognitive rehabilitation) with the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) to alleviate these cognitive deficits and evaluate its effect on anxiety-depressive symptoms and the quality of life of survivors.

Methods: A three-arm randomized superiority clinical trial, with a pre-post and follow-up repeated measures and intergroup design with a 1:1:1 allocation ratio will be carried out. A hundred and twenty-three breast cancer survivors with mild to moderate cognitive impairment will be randomly assigned to one of the interventions of the study: cognitive rehabilitation intervention group, an intervention group with UP intervention, or a control group on the waiting list. The primary outcome is to observe a significant improvement in cognitive function and quality of life in both intervention groups and a significant decrease in emotional impairments in comparison with the waitlist group. These results will be maintained at six months of follow-up.

Discussion: The aim of this work is to test the efficacy of the Unified Barlow Protocol in reducing cognitive deficits in breast cancer survivors. The results of this trial may be useful in reducing the presence of cognitive problems in survivors and improving their emotional state and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Cancer diagnosis, stages I-III.
* Cancer type: Breast.
* Have received the last chemotherapy session in the last 6 months and a maximum of 6 years of treatment completion.
* Probable or mild to moderate cognitive impairment (score between 26 and 10 points according to the MMSE).
* Ability to be fluent in Spanish.
* Not currently participating in another clinical trial.
* Not currently receiving other psychological treatment

Exclusion Criteria:

* Men and women aged \> 70 years.
* Diagnosis of cancer, stage IV or other types of cancer.
* Last chemotherapy session \< 6 months or \> 6 years.
* No cognitive impairment (MMSE score between 30 and 27 points).
* Diagnosis of mental disorder (including substance abuse) prior to cancer diagnosis.
* Relapse in disease after chemotherapy treatment is completed.
* Neurodevelopmental Disorder Diagnosis.
* Diagnosis of diseases that affect cognitive performance such as: hypertension, cardiac diseases, epilepsy, dementias, multiple sclerosis, functional disorders (fibromyalgia, chronic fatigue syndrome, irritable bowel syndrome, post-concussion syndrome, whiplash syndrome), CNS infections (HIV, encephalitis), metabolic disorders (diabetes, B12 deficiency), obstructive sleep apnea, brain damage (stroke, TBI, CNS cancer) and use of medications / substances that interfere with cognitive function such as pregabalin, gabapentin, topiramate, antidepressants tricyclics, sodium valproate, anticholinergics, methylphenidate, typical antipsychotics.
Add-on Effects of Valsartan on Morbi- Mortality (KYOTO HEART Study)

The KYOTO HEART Study is to assess the add-on effect of valsartan, an Angiotensin-Receptor Blocker, on top of the conventional treatment in high risk patients in Japan with hypertension in terms of the morbidity and mortality.

Although many reports show that ACE inhibitors and angiotensin II receptor blockers (ARB) are superior for prevention of cardiovascular events, previous data are not enough for the patients who have more than one risk factor and for anti-atherosclerotic effects of ARB. In Japan, there were only a few large-scale trials for cardiovascular disease prevention, and it has not been clarified whether the evidence in Western countries could be unqualifiedly applied to Japanese patients as a long-range strategy. The KYOTO HEART Study is to assess the add-on effect of valsartan, an Angiotensin-Receptor Blocker, on top of the conventional treatment in high risk patients with hypertension in terms of the morbidity and mortality.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of hypertension
* Clinical diagnosis of one or more risk factors, such as diabetes, smoking habit, lipid metabolism abnormality, history of ischemic heart disease (IHD) or cerebrovascular disease, obesity (BMI\>25), chronic heart failure (NYHA II-III), and electrocardiogram (ECG) abnormality (LVH)

Exclusion Criteria:

* Patients who have already been administered ARB
* Patients with IHD within 6 months after percutaneous coronary intervention(PCI), and who are stable but are going to implement PCI or coronary artery bypass grafting(CABG)
* Severe/malignant/secondary hypertensive patients
* Pregnant women and women of childbearing potential
* History of heart failure, unstable angina, myocardial infarction, PTCA, or CABG within the preceding 6 months
* Arrhythmia needed to be treated or accompanied with symptoms, second or third degree AV block
* Severe renal impairment (Serum creatinine \>3.0 mg/dl)
* Severe hepatic impairment (Hepatic failure, Cirrhosis, etc.)
Palatability Testing of a New Paediatric Formulation of Valacyclovir

Palatability testing of a new paediatric formulation of valacyclovir in children 4-12 years of age and at least one of their parents. Children will be included, who received (val)acyclovir prophylaxis in the past, or will probably need it in the future i.e. children with primary immune deficiency or cancer.


Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 4 years of age.
* Subject weighs at least 15kg.
* Subject is capable of performing the taste assessment, according to the investigator's judgement.
* The child and parent(s) are willing to participate in the taste assessment.
* Signed informed consent by the legal guardian for participation of the child and if the parent also wants to participate: signed informed consent for their own participation, prior to start of the study.

Exclusion Criteria:

* Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
* Presence of any condition that influences taste sensation (such as upper respiratory infection, febrile illness within 3 days before the first dose, mucositis or use of medication that influences taste perception, as described in the label information).
CES in the Elderly With Generalized Anxiety Disorders

The study aimed to investigate whether cranial electrotherapy stimulation(CES) could benefit anxiety symptoms, depressive symptoms, quality of sleep and quality of life in elderly patients with anxiety disorder.

Several studies have shown cranial electrotherapy stimulation (CES) could decrease depression and anxiety symptoms in patients with mood disorder. However, none study so far focused on the elderly population to investigate the anti-depressant and anxiolytic effect in elderly patient with anxiety disorder. Hence, this pilot study aims to assess the safety and efficacy of CES on anxiety symptoms, depressive symptoms, sleep quality and life quality in elderly patient with anxiety disorder. The study was an open-label, one arm study. The study aimed to investigate whether cranial electrotherapy stimulation(CES) could benefit anxiety symptoms, depressive symptoms, quality of sleep and quality of life in elderly patients with anxiety disorder.

Eligibility Criteria:
Inclusion Criteria:

* Aged 60 to 85 years old
* Anxiety disorder confirmed by Mini-international neuropsychiatric interview (MINI)
* HAM-A score greater than 17 points
* HAM-D score lower than 17 points
* Mini-mental state examination score of 24 or more
* No psychiatric medication adjustment within 3 months.

Exclusion Criteria:

* Comorbid with another axis I psychiatric disorder, like schizophrenia, substance use disorder or other major mental illness screened by Mini-international neuropsychiatric interview (MINI)
* Contraindications for CES
* Implanted brain medical devices or mental in the head
* History of seizures
* History of intracranial neoplasm or surgery
* Severe head injuries
* Cerebrovascular diseases
* Arrhythmia or with pacemaker implantation
* Used to receive brain stimulation therapy.
Feasibility of DPP-4 Inhibitor Therapy on Advanced Hybrid Closed Loop System

Background: Ramadan Iftar meal typically causes glucose excursions. Dipeptidyl peptidase-4 inhibitors increase serum concentrations of glucagon-like peptide-1 and thus, decrease blood glucose levels with low risk of hypoglycemia.

Aim: To investigate the efficacy and safety of vildagliptin as an add-on therapy among adolescents and young adults with type 1 diabetes mellitus (T1DM) on glucose excursions of Iftar Ramadan meals and glycemic metrics during advanced hybrid closed-loop (AHCL) treatment.

Current management of people with type 1 diabetes mellitus (T1DM) on intensive insulin therapy recognizes carbohydrates as the most important determinant of postprandial glycaemia; hence, worldwide guidelines recommend carbohydrates counting for determining pre-prandial insulin doses. Currently, the insulin to carbohydrate ratio (ICR) is frequently used to calculate the meal insulin dose. However, ICRs are considered difficult, ineffective and inaccurate for some patient, with an estimation error of around 20% in adults demonstrating only modest improvements in glycated hemoglobin (HbA1c). This lack of effectiveness and the wide variability using ICRs suggests it should be improved upon.

However, there have been only a few randomized control studies that investigated the efficacy and safety of DPP-4 inhibitors as an add-on drug in patients treated with basal insulin. Therefore, we conducted a one-month randomized control trial to investigate the efficacy and safety of DPP-4 inhibitors as an add-on therapy among adolescents and young adults with T1DM on glucose excursions of Iftar Ramadan meals and glucometrics during AHCL treatment .

Eligibility Criteria:
Inclusion Criteria:

* patients with type 1 diabetes (T1DM )for at least one year
* patients aged 12-27 years
* patients using MiniMed 780G AHCL system (Medtronic, Northridge, CA, USA) at least 6 months before the study
* patients with minimum daily insulin requirement of more than 8 units
* patients willingness and ability to adhere to the study protocol, access to the internet and a computer system that met requirements for uploading the study pump data.

Exclusion Criteria:

* patients with any microvascular or macrovascular complications
* pregnancy, lactation
* patients who had a point-of-care screening HbA1c \>10.0% (86 mmol/mol)
* patients with hypoglycemic unawareness or recurrent severe hypoglycemic episode in the last 6 months prior to recruitment
* patients with recurrent DKA (more than 2 episodes in the previous 6 months).
* patients with any chronic medical condition, current use of medications (other than insulin) that are known to affect blood glucose level.
* patients who had prior adverse reactions to the adjunctive agent
Feasibility of a Novel Process-based Treatment for Patients With Psychosis

The purpose of this single-arm feasibility study is to develop and pilot test a novel process-based and modular group therapy approach for patients with acute psychotic symptoms in an inpatient setting.

Due to the enormous economic and social costs of psychotic-spectrum disorders, increasing the effectiveness of treatment options has become an important subject for psychiatric research. Latest findings in the field of psychotherapy for psychosis show some promising results for so-called Process-based Therapies (PBT) such as the Metacognitive Training (MCT) and Acceptance and Commitment Therapy (ACT) (Barnicot et al., 2020). Instead of trying to change the content of psychotic symptoms such as hallucinations and delusions, PBT directly address cognitive processes, which have been found to maintain the disorder's symptomatology (Hayes et al., 2020). While MCT focusses on changing patients' cognitive biases by inducing metacognition (Moritz \& Woodward, 2007), ACT works with psychological processes such as mindfulness, willingness and cognitive distancing (Gaudiano \& Herbert, 2006). There is a growing study base for PBT in a psychotic outpatient setting, research in non-ambulatory settings though is rare (Barnicot et al., 2020). Therefore, the aim of the current study is to develop and test the feasibility and safety of a new process-based group therapy program for acute psychotic patients. The five-week treatment approach will consist of three different modules combining interventions from both MCT and ACT (Module I: Psychoeducation, Module II: Metacognition, Module III: Cognitive Defusion). First preliminary effectiveness and process measures (PANSS, BPRS, WHO-DAS, CGI, BCIS and CFQ) will also be included in order to inform the design of future research. Thus, the study will give valuables insights in the feasibility and effectiveness of an innovative psychotherapy approach and breaks new ground in the field of psychotherapy research for psychosis.

Eligibility Criteria:
Inclusion Criteria:

* Main diagnosis of a mental disorder with psychotic symptoms according to ICD-10 criteria currently experiencing delusions and hallucinations (F20, F21, F22, F23, F24, F25, F28, F29, F30.2, F31.2, F31.5, F32.3, F33.3) indicated by diagnostic assessment of attending MD
* Age between 18 and 70 years
* Informed consent to the study procedures and assessments (in written form)

Exclusion Criteria:

* Severe neurological or internal concomitant diseases
* IQ \< 80; severe learning disability, brain damage or pervasive developmental disorder
* Missing eligibility for psychotherapy because of missing language skills/hostile or uncooperative behaviour.

No further constraints will be imposed in order to collect data in a representative clinical sample.