cyrilzakka/clinical-trials huggingface dataset:
A Pilot, Feasibility Study of Intermittent Caloric Restriction Plus Plant-based Diet in Cancer Patients Receiving Chemotherapy

Caloric restriction may alter the response to chemotherapy induced stress response and enhance its antitumor effect. This study intends to use an intermitted caloric restriction protocol with alternate days before the chemotherapy administration to enhance the cytotoxic effect generated by standard treatment of cancer.

This pilot trial will provide preliminary evidence that 1) intermittent caloric restriction and a plant-based diet is feasible in cancer patients; 2) intermittent caloric restriction and a plant-based diet can be safely combined with standard chemotherapy; and 3) intermittent caloric restriction and a plant-based diet may reduce the side effects but increase the antitumor effects of standard chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* • Histologically documented, cancer patients who are eligible to receive cytotoxic chemotherapy.

  * Life expectancy of at least 6 months
  * Adults ≥ 18 years of age
  * Adequate hematologic, renal, and liver function as evidenced by the following:

    * White blood cell (WBC) ≥ 2,500 cells/μL
    * Absolute neutrophil count (ANC) ≥ 1,000 cells/μL
    * Platelet Count ≥ 100,000 cells/μL
    * Hemoglobin (HgB) ≥ 9.0 g/dL
    * Creatinine ≤ 2.0 mg/dL
    * Total bilirubin ≤ 2 x upper limit of normal (ULN)
    * Aspartate aminotransaminase (AST, SGOT) ≤ 2.5 x ULN
    * Alanine aminotransaminase (ALT, SGPT) ≤ 2.5 x ULN

Exclusion Criteria:

* • Eastern Cooperative Oncology Group (ECOG) performance status 2 or higher

  * Treatment with any of the following medications or interventions within 28 days of registration:

    * Systemic corticosteroids; however, use of inhaled, intranasal, and topical steroids is acceptable.
    * High dose calcitriol \[1,25(OH)2VitD\] (i.e., \> 7.0 μg/week)
  * Any infection requiring parenteral antibiotic therapy or causing fever (temperature \> 100.5°F or 38.1°C) within 1 week prior to registration
  * A known allergy, intolerance, or medical contraindication to receiving the contrast dye required for the protocol-specified CT/MRI imaging
  * Any medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence with study requirements or otherwise compromise the study's objectives
Mindfulness-based Intervention in Police Officers - the POLICE Study

The physical, emotional, economic and social damage of stress in the police corporation indicates an urgent call for preventive programs to approach stress reduction, burnout symptoms and promotion of quality of life and well-being.

The aim of the POLICE study is to evaluate the effectiveness of a Mindfulness-based intervention (MBI), compare to a waiting list (WL), in promoting quality of life and mental health in police officers.

Police officers are submitted to a high burden of chronic stress. It is no surprise to find that this occupation ranks highest on diseases and accidents rates among all professions. These professionals presents a very high incidence of depression, anxiety disorders, alcohol dependence and suicidal behavior. In addition to mental health suffering, evidence suggests an increase risk of sudden cardiac death, diabetes, obesity and metabolic syndrome.

Mindfulness-based interventions have been tested and incorporated for several clinical and non-clinical conditions for more than three decades, with emphasis on stress reduction, promotion of quality of life, chronic pain, anxiety, depression and eating disorders.

The main hypothesis is that mindfulness training will improve their quality of life and reduce burnout symptoms. The investigators expect that individuals allocated in the MBI group will report, besides showing a better quality of life, mental health and less burnout, lower levels of stress, anxiety and depression symptoms.

With regard to the working mechanism of the MBI, investigators will examine if the changes in mindfulness trait, self-compassion, spirituality, decentering and resilience skills will mediate the main hypothesis.

The study will be conducted in Porto Alegre-RS and São Paulo-SP.

Eligibility Criteria:
Inclusion Criteria:

* Active Police Officers
* Availability to attend 8 sessions
* Willingness to voluntarily participation

Exclusion Criteria:

* Manic or hypomanic episode (current)
* Psychotic syndrome (current or past)
* Substance Use Disorder (past 12 months, except tobacco)
* Risk of suicide
* Previously completed Mindfulness-Based Intervention
Intervention to Improve Driving Practices Among High-Risk Teen Drivers

The purpose of this study is to test the effects of an in-vehicle driving feedback technology, with and without parent communication training, on risky driving events, unsafe driving behaviors, and subsequent traffic violations among teens who have recently received a moving traffic violation.

For this study, 240 teen and parent/guardian dyads will be randomized into one of three study groups for six months. Teens will be aged 16-17 who committed a moving-related traffic violation and their parent/legal guardian who is most involved with their driving. Researchers will aim to determine the effects of the intervention on teens' risky driving events, unsafe driving behaviors, and traffic violation recidivism. Additionally, researchers will aim to determine the effects of the intervention on frequency and quality of parent-teen communications about safe driving practices.

Eligibility Criteria:
Inclusion Criteria:

* Age 16-17 years at time of violation
* Convicted of a moving violation
* Possess a valid intermediate driver's license issued by the state of Ohio, with proof of car insurance
* Access to a vehicle with an On-board Diagnostics II system port (i.e. cars made after 1996) in which he/she is the primary driver
* Smartphone with Bluetooth capabilities
* At least one legal guardian

Exclusion Criteria:

* Unable to drive due to injury, license suspension, or car damage
* Vehicle already has an in-vehicle driving feedback system installed
* Extremely low average weekly drive time (e.g. \<1 hour per week)
* Currently enrolled in another driving-related study
* War of the State
* Non-English speaking parent
* Adults unable to consent
* Pregnant women
* Prisoners
Adaptive Implementation Intervention for VA Suicide Risk Identification Strategy

The overall objective of this national quality improvement project is to develop an adaptive implementation strategy to improve the implementation of suicide risk screening and evaluation in Veterans Health Administration ambulatory care settings (i.e., VA Risk ID).

VA Risk ID is the largest implementation of population-based suicide risk screening and evaluation in any United States healthcare system to date. Given the considerable scope of this initiative, several strategies have been employed to support national implementation. To facilitate continuous quality improvement, ongoing evaluation of VA Risk ID and interventions to improve implementation of the three-stage screening and evaluation process are needed. This project is intended to help VHA facilities address challenges to implementing VA Risk ID to fidelity using a sequence of evidence-based implementation strategies (audit and feedback followed by audit and feedback plus external facilitation). By doing so, it will ensure that more Veterans are screened and evaluated for suicide risk, which is the basis of effective, patient-centered suicide risk management. By adapting the implementation intervention "dose" based on facility performance and monitoring implementation over time, this project will allow the program office to focus resources where and when needed the most.

Eligibility Criteria:
Inclusion Criteria:

* Intervention occurs at the site/facility level. Up to 140 VHA facilities across the country will participate in the project. Sites will be allocated to various interventions based on performance (i.e., pre-determined benchmarks for adequate implementation).

Exclusion Criteria:

* This is a national quality improvement project. Sites that are randomized to different intervention arms based on performance may refuse to participate in the implementation interventions.
Goserelin for Ovarian Protection in Premenopausal Patients Receiving Cyclophosphamide

The use of adjuvant chemotherapy in younger women with early breast cancer (EBC) has substantially improved the long-term outcome. However, this benefit is associated with long-term toxic effects which are becoming more important as prognosis improves. These include premature menopause and infertility in young pre-menopausal women. The incidence of premature menopause depends on the type and intensity of chemotherapy and the patient's age. In women \<35 years old, the long-term (3 years after diagnosis) incidence of amenorrhea is similar to women who have not received chemotherapy, at ∼ 10%, but this increases to 50% in women between 35 and 40 years old, and can be up to 85% in women \>40 years. Premature ovarian failure has major consequences including sexual dysfunction and infertility, and the latter may be of great concern to younger patients with breast cancer and has a bearing in influencing treatment decisions in almost 30% of cases.

Currently, there is no standard treatment for preventing chemotherapy-induced ovarian failure. Previous studies have suggested that temporary ovarian suppression with a gonadotropin-releasing hormone (GnRH) analogue may preserve ovarian function both in humans and animal models. Clinical data are conflicting. For example, a recent Italian multi-center phase III study Prevention of Menopause-Induced by Chemotherapy: A Study in Early Breast Cancer Patients-Gruppo Italiano Mamella 6 (PROMISE-GIM6) reported that the use of GnRH analogue, triptorelin during chemotherapy in pre-menopausal patients with EBC, reduced the occurrence of chemotherapy-induced early menopause with four pregnancies after a 26-month follow-up \[one in the chemotherapy alone arm and three in the triptorelin with chemotherapy arm\]. In contrast, another trial suggested that the use of goserelin concurrently with neoadjuvant chemotherapy did not significantly reduce incidence of amenorrhea 6 months after the end of chemotherapy compared with those receiving chemotherapy alone and only two pregnancies were recorded \[one in each arm\] with a follow-up of 2 years.

In this phase II trial, patients will be randomly assigned, in a 1:1 ratio, to standard adjuvant or neoadjuvant chemotherapy with the GnRH agonist goserelin (goserelin group) or to chemotherapy without goserelin (chemotherapy alone group).

For Patients randomly assigned to the goserelin group, goserelin at a dose of 3.6 mg will be administered subcutaneously every 4 weeks beginning 1 week before the initial chemotherapy dose and will be continued to within 2 weeks before or after the final chemotherapy dose.

Follow up: All patients will be followed for at least 1 year clinically monthly and by laboratory assessment by hormonal profile (FSH, LH, E2) every 6 months.

Eligibility Criteria:
Inclusion Criteria:

Premenopausal cancer patients who will receive Cyclophosphamide-containing chemotherapy.

Exclusion Criteria:

postmenopausal cancer patients. cancer patients who will receive non Cyclophosphamide containing chemotherapy.
StatSeal vs Figure-of-Eight Suture for Vascular Closure in AF Ablation

This study, titled aims to compare two vascular closure techniques after catheter ablation for atrial fibrillation (AF). Catheter ablation is a common procedure used to treat AF, but after the procedure, It is important to close the access site in the blood vessel to prevent bleeding. This study will evaluate whether the StatSeal device, a haemostatic disc, can help patients recover more quickly compared to the traditional figure-of-eight suture technique.

The primary objective of the study is to determine whether StatSeal reduces the time it takes for patients to start walking after the procedure (known as Time to Ambulation). Secondary objectives include comparing the time to complete haemostasis, discharge eligibility, incidence of adverse events, and patient comfort between the two techniques.

Participants in the study will be randomly assigned to receive either the StatSeal device or the figure-of-eight suture after their AF ablation procedure. The study will recruit 160 participants across multiple hospital sites, with 80 participants in each group. Both techniques are standard methods, and participants will be closely monitored for safety throughout the study.

By comparing these two closure techniques, the study aims to improve the recovery process for patients undergoing AF ablation and provide evidence on which method leads to better outcomes and patient experiences.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients age \&gt;18
* Elective catheter ablation for atrial fibrillation using a 6 to 14 Fr inner diameter introducer sheath with a minimum of 1 and maximum of 3 femoral venous access sites
* Willing and able to give informed consent

Exclusion Criteria:

* Active systemic or cutaneous infection, or inflammation in vicinity of the groin
* Platelet count \&lt; 100,000 cells/mm3
* BMI \&gt; 45 kg/m2 or \&lt; 20 kg/m2
* Attempted femoral arterial access or inadvertent arterial puncture
* Procedural complications that interfered with routine recovery, ambulation, or discharge times
* Incorrect sheath placement
* Intraprocedural bleeding or thrombotic complications
* Access site-specific eligibility criteria to exclude problems with gaining access or location of sheath
* History of bleeding diathesis, coagulopathy, hypercoagulability, or thromboembolic events
Physician-Nurse and Nurse-Nurse Collaboration

This study was carried out to determine the level of collaboration and the factors affecting its between physicians-nurses and nurses-nurses working in different hospitals.

Collaboration is a broad concept with different definitions in the literature. Researches on physician-nurse collaboration and nurse-nurse collaboration has shown that improves the quality of patient care; reduces the medical errors; affects the job satisfaction positively and decreases the intention to quit in the international literature. In the light of this information, the study was planned to determine the level of collaboration and the factors affecting its between physicians-nurses and nurses-nurses working in different hospitals. Research is a cross-sectional study. The study is planned the 500 nurses working in six hospitals in Ordu/Turkey on January 3-12 February 2019. Descriptive questionnaire form, Jefferson Scale of Physician-Nurse Collaboration (JSAPNC) and nurse-nurse collaboration scale will be used in the study.

Eligibility Criteria:
Inclusion Criteria:

* nurse
* working experiences at least 6 months
* working full time.

Exclusion Criteria

* working experiences less than 6 months
* head-nurses
Effect of Video-Assisted Training on Upper Extremity Problems and Functions in Patients Undergoing Rotator Cuff Repair

This randomized controlled trial evaluates the effect of video-assisted training (VAT) on upper extremity problems and functions in rotator cuff repair (RCR) patients. The hypothesis of this study is that VAT decreases upper extremity problems and increases functions after RCR.

Methods: Forty-eight elective RCR patients were randomly assigned to VAT and control groups. VAT group (n=24) received VAT including early post-operative care for RCR, activities of daily living (ADL) and gradual exercise program while control group (n=24) received routine care. Primary outcomes were upper extremity problems and functions, assessed using Disabilities of the Arm, Shoulder and Hand (DASH) and Modified Constant-Murley (MCM) scores. Secondary outcomes were complications within three months. Outcomes were collected at baseline, after six weeks and three months.

Eligibility Criteria:
Inclusion Criteria: Patients who

* underwent elective RCR for the first time;
* whose arm was suspended and fixed for up to three weeks after RCR;
* had an SMMT score of ≥23 points;

Exclusion Criteria: Patients who

* had been diagnosed with a psychiatric illness;
* have any history of an upper extremity fracture or a rheumatologic disease;
Impact of a Short-Term High Fat or Low Fat Diet on Intestinal Genes Expression Involved in the Cholesterol and Fatty Acid Metabolism

Dietary fat has been shown to modulate cholesterol and fatty acids homeostasis and several lines of evidence suggest that this effect is associated with changes in the regulation of different genes at the intestine level involved in the cholesterol and fatty acid metabolism pathways. The present study will examine the impact of a short-term high fat diet versus a short-term low fat diet on expression of Niemann-Pick C1-like 1 (NPC1L1), adenosine triphosphate (ATP) binding cassette transporters (ABCG5/8), microsomal triglyceride transfer protein (MTP) and fatty acid transport protein-4 (FATP4), which have been shown to play a critical role in intestinal cholesterol absorption, chylomicron synthesis and dietary lipid absorption. Gene expression studies will be performed on duodenal biopsies. The primary hypothesis is that a short-term high fat diet will significantly decrease duodenal messenger ribonucleic acid (mRNA) levels of NPC1L1, ABCG5/8, MTP and FATP4 as compared with a short-term low fat diet.


Eligibility Criteria:
Inclusion Criteria:

* Males 18 to 50 years of age
* Non-smoker
* Body mass index between 20.0 and 30.0 kg/m2
* Plasma LDL-cholesterol levels between the 25th and 75th percentile for their age at day -14
* Plasma triglyceride levels \< 1.7 mmol/L (150 mg/dl) at day -14
* Plasma HDL-cholesterol levels between 0.9 (35 mg/dl) and 1.6 mmol/L (60 mg/dl) at day -14
* Subjects must be willing to give written informed consent and able to adhere to the diet schedule and visit schedule
* Patients should be otherwise healthy, without elevations in hepatic transaminases or creatine kinase (CK) or abnormal renal function or coagulation

Exclusion Criteria:

* Patients with extreme dyslipidemias, such as familial hypercholesterolemia will be excluded
* Subjects will be excluded if they have cardiovascular disease (CHD, cerebrovascular disease or peripheral arterial disease) or if they are taking other medications known to affect lipoprotein metabolism (eg. steroids, beta blockers, thiazide diuretics, other lipid lowering agents, significant alcohol intake etc.)
Intranasal Dexmedetomidine vs Midazolam-ketamine Combination for Premedication of Pediatric Patients

The aim of this study is using intranasal dexmedetomidine versus intranasal midazolam-ketamine combination for premedication and preventing the oculocardiac reflex of pediatric patients undergoing strabismus surgery.

Preanesthetic medication in pediatrics is very helpful in relieving anxiety, fear and psychological trauma due to maternal deprivation. Midazolam and ketamine are commonly used for this purpose. Dexmedetomidine is an alpha 2 -agonist with a more selective action on the alpha 2 adrenoreceptor when administered via the nasal mucosa bioavailability of dexmedetomidine is too high. Intranasal route is an effective way to administer premedication and sedation to children. The oculocardiac reflex is a major complication of pediatric strabismus surgery.

Eligibility Criteria:
Inclusion Criteria:

* the pediatric patients undergoing strabismus surgery
* the pediatric patients between 2-11 years old
* ASA physical status I-II
* the patients whose parents give permission for this study

Exclusion Criteria:

* a known drud allergy or hypersensitive reaction to drugs used
* mental retardation
* cardiac arrhythmia or congenital cardiac disease
* organ disfunction (liver , kidney)
* nasal pathology
* psychotropic treatment
Renal Replacement Therapy and In-Hospital Mortality Incidence in Cardiac Surgery Associated Acute Kidney Injury

The goal of this study is to analyse the relation of severe acute kidney injury post cardiac surgery which characterised by the need of renal replacement therapy, with in-hospital postoperative mortality incidence.

The main question it aims to answer:

To compare between patients complicated with acute kidney injury and exposure of renal replacement therapy (AKI-RRT) and patients complicated with acute kidney injury which does not require renal replacement therapy, in associated with in-hospital postoperative mortality.

Type of study: observational study

Participant population: Post cardiac surgery patients with condition of acute kidney injury postoperative, will be assigned into 2 groups, based on their exposure to renal replacement therapy. Those groups are:

Group AKI-RRT : patients with AKI postoperative with exposure of renal replacement therapy Group AKI non RRT : patients with AKI postoperative, with no exposure to renal replacement therapy Researchers will compare group AKI-RRT and AKI non RRT to analyse the association to postoperative mortality, and other factors that related to mortality variable.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are at least 18 years old, underwent cardiac surgery in Harapan Kita National Cardiovascular Center from January 2020 to December 2022.
2. Patients with condition was complicated with Acute Kidney Injury (AKI) which was characterised by an increase in serum creatinine \> 0.3 mg/dL or \> 150% of the preoperative serum creatinine value, which was checked within 12 hours post-operative.
3. All patients' data is recorded in the medical records unit.

Exclusion Criteria:

1. Patients with previous history of dialysis or renal failure in dialysis.
2. Incomplete or loss of patients' data.
Toripalimab or Placebo as Adjuvant Therapy in Hepatocellular Carcinoma After Radical Resection

This study will investigate if Toripalimab (A PD-1 Inhibitor) will improve recurrence-free survival (RFS) compared to placebo in participants with HCC and are at high risk of recurrence after complete resection with no residual of tumour.


Eligibility Criteria:
Inclusion Criteria:

1. HCC with at least one protocol defined risk factor, diagnosed confirmed by central pathological review and received R0 resection;
2. BICR confirmed no resdual tumor lesions are detected in liver;
3. Child-Puch score, Class A;
4. ECOG score is 0;

Exclusion Criteria:

1. Patients previously received PD-1 antibody, PD-L1 antibody, PD-L2 antibody or CTLA-4 antibodies, including those who have participated in the JS001 clinical study;
2. Portal vein tumor thrombi or liver metastases or recurrent liver cancer;
3. With symptoms of central nervous system metastasis;
4. With any history of active autoimmune disease or autoimmune disease;
5. Known liver diseases with clinical significance;
6. Patients infected by hepatitis B virus (HBV), hepatitis C virus (HCV), hepatitis D virus (HDV):

Other protocol defined inclusion/exclusion criteria could apply