cyrilzakka/clinical-trials huggingface dataset:
The Effect of Mindfulness-Based Stress Reduction Programme on Smartphone Addiction, Stress and Quality of Life in University Students

The aim of this observational study was to examine the effect of Mindfulness-Based Stress Reduction Program on Smartphone Addiction, Stress and Quality of Life in Nursing Students. The main question it aims to answer is:

Is there a significant relationship between smartphone addiction, quality of life and stress in nursing students? Smartphone addiction scale will be applied and students with risky scores will be determined and pre-test will be applied to the students in the experimental group according to randomization. During an 8-week intervention period, in addition to mindfulness practices and experiential studies, experiential practices will be carried out on stress, stress management and how mindfulness is applied in daily life and interpersonal communication through the sharing of the participants.

This study was conducted to investigate mindfulness-based stress reduction in nursing students.

To determine the effect of the program on smartphone addiction, stress and quality of life will be carried out for this purpose. The data obtained in the study will only be used in this study. This You will not be charged for the study and you will not receive any remuneration.

Information about you will be kept confidential, but officials overseeing the quality of the study, ethics will be examined if deemed necessary by committees or authorities. Smartphone addiction scale was administered, students with risky scores were identified, and the students who received risky scores were identified during an 8-week intervention period.

in addition to mindfulness practices and experiential work Through the participants' sharing, stress, stress management and mindfulness in daily life and how it is applied in interpersonal communication will be done. After this process is over, the post-test will be applied and necessary analyzes will be made. Education a follow-up test will be performed 12 weeks after the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Individuals over 18 years of age,
* From the highest on the smartphone addiction scale students from the beginning until the sample size is reached
* No diagnosed psychiatric illness or medication not to use it,
* Volunteering to participate in the study
* Muş Alparslan University at the time of the research Continuing education in the Department of Nursing

Exclusion Criteria:

* Students who did not participate in at least two group programs and
Effects of Wolffia Globosa (Mankai) in Patients Undergoing Bariatric Surgery.

Candidates to bariatric surgery at The Bariatric and Metabolic Institute at Cleveland Clinic Florida are prescribed a high protein liquid diet for two weeks preoperatively and 2 weeks postoperatively. Whether Wolffia Globosa (Mankai), a plant based wholesome food, can serve as a natural alternative to liquid diet during the 2 week pre-operation and 2 weeks postoperation liquid based diet, is unknown.

The investigators aim to address the effect of daily Wolffia Globosa (Mankai) administration on morbid/severely-obese patients during the 2 week pre-operative period and 2 weeks postoperatively as compared to iso protein-iso caloric shake source on the following parameters

This study is a prospective study involving patients selected for elective surgery. Patients undergoing bariatric surgery will be enrolled in this study and have several parameters checked as explained below. Patients selected and consented for elective bariatric surgery will be recruited in the Bariatric and Metabolic Institute to participate in this study and will undergo standard of care. The investigators will enroll approximately 120 candidates during a 6 months (\~5 a week) period. Patients will be randomized to the A. control group: 3 traditional shakes or B. intervention group: 2 traditional shakes and 1 daily administration of substituting iso-protein green Wolffia Globosa (Mankai) Shake (4 frozen cubes of Wolffia Globosa (Mankai) equal to 20 grams of dry Wolffia Globosa (Mankai). Each shake will provide equivalent carbohydrate, calories and protein levels from the respective source. As part of our routine pre and postoperative screening and follow up protocol, the investigators will collect anthropometric and clinical data on all patients, including standard of care blood samples collected at 2 weeks pre operatively, surgery day and at 2 months postoperatively

Eligibility Criteria:
Inclusion Criteria:

• Patients that will undergo sleeve gastrectomy.

Exclusion Criteria:

* Age below 18 years
* American Society of Anesthesiologist (ASA) class IV or V
* Patients using Vitamin-K antagonists
* Patients with documented coagulopathies.
Genomic Profiles Analysis in Children, Adolescents and Young Adult With Sarcomas

Bone and soft tissue sarcomas represent about 7-12% of all pediatric cancer and are a heterogeneous group of tumors arising in connective tissues embryologically derived from the mesenchyme. For some of these tumors relapse and mortality rates are still significantly high. Therefore, further studies are needed to better understand pathogenetic processes underlying sarcomas to offer new and more effective treatments. Next generation sequencing (NGS) has opened new frontiers for cancer research allowing to identify somatic or constitutional mutations known or yet unknown with the aim to better understand carcinogenesis. The establishment of the genomic profile of the tumor could also help clinicians to personalize patients treatment based on their genetic and molecular alterations.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with histologically confirmed Osteosarcoma, Ewing Sarcoma or Synovial Sarcoma at first diagnosis.
2. Patients with confirmed relapsed/refractory Osteosarcoma, Ewing Sarcoma or Synovial Sarcoma
3. Written informed consent signed by the patient, or parents or legal representative to perform molecular analysis of the tumor sample.
4. Patients aged ≤24 years
5. Pathological review of tumor samples.
6. Availability of fresh tumor sample from newly diagnosed or relapsed/refractory cancer and 10 ml of EDTA peripheral blood sample. Centralization of paraffin-embedded tumor sample might be optional.

Exclusion Criteria:

* 1. Known history of active HIV, HCV, or HBV infection 2. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient undergoing surgery biopsy or the quality of the data.
Optimization of Treatment of Advanced Nonsmall Cell Lung Cancer Using Radiotherapy and Chemotherapy

Primary objectives of the study are:

To assess the differences in survival of the two treatment options in both stage III (A and B) nonsmall cell lung cancer (NSCLC) (Study A) and Stage IIIB (wet) and stage IV NSCLC (Study B), respectively

Secondary objectives are:

To assess the differences in toxicity of two treatment options in both stage III (A and B) NSCLC (Study A) and Stage IIIB (wet) and stage IV NSCLC (Study B), and To assess the differences in Health Related Quality of Life (HRQoL) of two treatment options in both Study A and Study B

To compare survival rates (median and 1-year), and toxicity of two treatment regimens in patients with locally advanced incurable NSCLC (study A), to compare survival rates (median and 1-year) of two treatment regimens in patients with locally advanced and metastatic NSCLC (study B)

To compare HRQoL and cost effectiveness of two treatment regimens in patients with locally advanced incurable NSCLC (study A), and in patients with locally advanced and metastatic NSCLC (study B) and to evaluate the effect of HRQoL assessment on QoL dimensions

Eligibility Criteria:
Study A Inclusion Criteria:

* Histologically or cytologically confirmed NSCLC
* Stage IIIA/IIIB staged with
* CT chest and upper abdomen
* Liver, renal, hematological reserve appropriate (according to "standard" institutional values)
* Brain CT and/or bone scan only if clinical symptoms request such investigation
* Performance status KPS 60-90
* No second cancer except skin non-melanoma
* No previous treatment
* Patient must be contactable for follow-up
* Patient to be able to start treatment within 2 weeks from randomization (institutional confirmation needed)
* Life expectancy \> 3 months
* Patient must be able and willing to give informed consent, and fill in questionnaires

Study A Exclusion Criteria:

* Stage III B "wet" (existing pleural effusion , but not necessarily cytologically verified)
* RT field \> 200 cm2
* Pregnancy

Study B Inclusion Criteria:

* KPS 60-90
* Stage IV and Stage III B (existing pleural effusions , but not necessarily cytologically verified)
* Histologically or cytologically confirmed
* CT staged disease (thorax and possible upper abdomen)
* No second cancer except skin non-melanoma
* Liver, renal, haematological reserve appropriate (according to "standard" institutional values)
* No previous treatment
* Patient must be contactable for follow-up
* Patient must be able and willing to give informed consent and fill in questionnaires
* Patient to be able to start treatment within 2 weeks from randomization (institutional confirmation needed)
* Life expectancy \> 3 months

Study B Exclusion Criteria:

* Brain metastasis (brain CT and/or MRI not needed, unless symptoms exist - clinically indicated)
* RT field \> 200 cm2
* Pregnancy
* A-P separation too large to be adequately treated with 60-Co (?)
A New Method for Treatment of Deep Venous Insufficiency: Early Results of Vein Restoration Treatment(VRT)

To present the 9. months clinical results of percutaneous Ven Restoration Therapy (VRT), a new method in the treatment of primary femoral vein insufficiency.Twenty four patients diagnosed with isolated primary femoral vein insufficiency between January 2020 and December 2020 were included in the study. Before the procedure, junctional femoral vein diameters and reflux times were measured. CEAP classification and Venous clinical severity scores (VCSS) were recorded. Chronic Venous Insufficiency Questionnaire (CIVIQ-20) were also recorded. Then, VRT was applied percutaneously to the anterior and posterior of the femoral veins of the patients, and the diameter of the femoral vein was narrowed and valve coaptation was achieved. After the procedure, vein diameters and reflux times were measured again. All parameters were reevaluated by calling patients for control at 1.,3., 6. and 9. months.


Eligibility Criteria:
Inclusion Criteria:

* Patients with isolated deep venous insufficiency, without accompanying superficial venous insufficiency,
* volunteering to take part in the study were included

Exclusion Criteria:

* post-thrombotic or congenital deep venous insufficiency
* Venous reflux disease in the GSV diagnosed by clinical symptoms
* Local or systemic infection
A Prospective, Open-ended, Multi-center Study of Schizophrenia Patients Switching to Zolodine

Through self-controlled studies on metabolic syndrome related indicators, efficacy and other adverse reactions in patients with schizophrenia who developed metabolic syndrome after treatment with other antipsychotics, switched to Zoladine capsules (ziprasidone hydrochloride capsules). To evaluate the clinical application value of switching to Zolodine for schizophrenia patients with metabolic syndrome, and to explore the drug selection strategy for long-term treatment of schizophrenia patients.


Eligibility Criteria:
Inclusion Criteria:

* Meet the DSM-IV diagnostic criteria for schizophrenia, patients aged 18-40 years old have been treated with other antipsychotics for more than 8 weeks (inclusive) before being included, meet the diagnostic criteria for metabolic syndrome (IDF, 2005), and have not reached diabetes , Patients with diagnostic criteria for hypertension.

Exclusion Criteria:

* Female patients who are pregnant or breastfeeding;
* Serious and unstable physical diseases, including: cardiovascular, respiratory, liver, kidney, gastrointestinal, nerve, endocrine, immune, blood system, narrow-angle glaucoma, history of seizures;
* Patients with refractory schizophrenia;
* Those who meet the DSM-IV standards for dementia or substance dependence (except tobacco);
* Patients with a history of contraindications to ziprasidone or intolerance of ziprasidone;
* Patients who use long-acting antipsychotic injections or oral medications;
* Patients who have recently experienced prolonged QT interval, acute myocardial infarction, and decompensated heart failure;
* Patients have recently taken drugs that can prolong the QT interval, such as dofetilide, sotalol, quinidine, other class Ia and III antiarrhythmic drugs, mesoridazine, thioridazine, Chlorpromazine, droperidol, pimozide, sparfloxacin, gatifloxacin, moxifloxacin, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadone, dolastron methanesulfonate Acid, probucol or tacrolimus;
* At the same time taking other drugs that can cause obesity, such as oral contraceptives;
* Patients who have met metabolic syndrome before diagnosis and treatment of schizophrenia.
Patient and Public Involvement (PPI) in Non-pharmacological, Non-commercial Spanish Clinical Trials

Patient and public involvement (PPI) in the design and conduct of clinical trials has been encouraged for many years. Yet, there is no data available describing how many trials sponsored by non-commercial Spanish individuals or organizations have liaised with patients, relatives or caregivers and the public to consider their preferences and values in the design of trials assessing non-pharmacological interventions.

This systematic review will be conducted in clinical trial registers that host non-pharmacological trials.

PPI is not an item of the information included on clinical trial registers. Thus, the objective of this study is to describe the percentage of non-pharmacological non-commercial Spanish trials with PPI as reported in published reports. For this reason our interest is on trials that have been completed. The published reports of interest are those that first described main trial results; those describing trial protocols. In the abscence of peer-reviewed reports, preprints will be considered. No other type of reports will be considered as valid source of information.

The study will review the trials (i.e.,interventional studies) conducted in Spain, and completed between September 01, 2009 and September 01, 2024. Five registers will be reviewed: clinicaltrials.gov, ISRCTN, DRKS, REBEC, and ACTRN. It is assumed that most of non-pharmacological non-commercial Spanish-sponsored trials will be registered in these five registers as per the information gathered from a previous study on COVID-19 Spanish non-commercial trials. The published reports of all completed trials from these four registers will be searched on PubMed and Google Scholar by using the trials IDs. Corresponding authors will be contacted only in the case it is impossible to retrieve the article or preprint.

In addition to PPI, and to characterize the trials, several variables will be also captured from the articles such as trial design, number of participants, condition/indication, type of intervention, year of publication, number of citations, citations/year, whether the trial was conducted following the Declaration of Helsinki proisions, whether all authors were non-physicians, and data availability statement. In addition, where was the trial registered. We will also register the Spanish region where the sponsor was located, information that will only be used in case it is deem necessary. In other words, the information to be gathered should be captured from the published reports.

Eligibility Criteria:
Inclusion Criteria: Spanish sponsor; non-commercial sponsor. -

Exclusion Criteria: trials assessing pharmacologic interventions.

-
Association of T1-mapping and LV Strain Analysis by CMR

The association of T1-mapping (both native and ECV) and strain analysis of LV and RV by CMR will be assessed. Results from strain analysis will be investigated in terms of their prognostic value.


Eligibility Criteria:
Inclusion Criteria:

* undergoing CMR
* willingness to participate

Exclusion Criteria:

* \<18 years old
* pregnancy
Drug Study in Pediatric Subjects With Migraines (MK0462-083 AM1)

A study to assess the safety, tolerability, and single dose pharmacokinetics of a marketed drug in pediatric subjects with migraines.

After completion of a portion of the study (Panels A and B), a regulatory agency issued an amended request that the 12-17 year old age group studied should include a similar number of male and female subjects. Therefore, the study was amended to add an additional panel of subjects (Panel C) to ensure gender balance specifically in this age group.


Eligibility Criteria:
Inclusion Criteria:

* Panel A and B: Male and female subjects (non-smokers) ages 6 to 17 with a history of migraines
* Panel C: Male subjects (non-smokers) ages 12 to 17 with a history of migraines
* Subject has a history of migraine headaches, and is not experiencing a migraine on the day of study drug administration

Exclusion Criteria:

* Subject has no history of migraine headaches
* Taking medications that are monoamine oxidase inhibitors (MAOI) and selective serotonin reuptake inhibitors (SSRI)
* Subject has a condition which, in the opinion of the investigator, may interfere with optimal participation in the study
Optimal Coronary Flow After PCI for Myocardial Infarction - a Pilot Study

In this study the investigators test the hypothesis that alteplase given intra coronary after PCI reduce infarct size in patients with ST-elevation myocardial infarction(STEMI) and impaired microvascular function defined as a value of index of microvascular resistance (IMR) \>30.

After coronary stenting, index of microvascular resistance (IMR) will be measured invasively. Patients with IMR \>30 will be randomised to 20 mg alteplase or placebo (NaCl) administered in the culprit vessel through a microcatheter. Magnet resonance imaging (MRI) of the myocardium will be performed early (2-6 days) and late (3 months) to estimate the primary endpoint (infarct size).

10 non-randomised patients, with IMR \<30, will undergo the same follow-up as the randomised patients.

Clinical events for all randomised and non-randomised patients will be collected from Swedish national registries and by telephone at 3 and 12 months.

Eligibility Criteria:
Criteria for randomization:

1. IMR measured in culprit vessel \> 30

Criteria for IMR measurement:

Inclusion Criteria:

1. Oral and signed informed consent
2. Males and females 18 - 85 years of age
3. Diagnosis of ST-elevation myocardial infarction (STEMI) including occlusion of culprit vessel on angiography
4. Onset of continuous symptoms within 12 hours
5. Have undergone PCI of culprit vessel
6. Subjects are willing to comply with scheduled visits and tests and are able and willing to provide informed consent

Exclusion Criteria:

1. Previously known ejection fraction \<30%
2. Previous PCI in the culprit vessel
3. Chronic total occlusion in major vessel
4. Any history of bleeding diathesis, known coagulopathy, or will refuse blood transfusions
5. Recent history or known platelet count \<100.000 cells/mm3 or Hbg \< 10 g/dL
6. Known reduced kidney function with estimated glomerular filtration rate (GFR) \<30 ml/min/1.73m2.
7. Previous hemorrhagic stroke
8. Ongoing oral anticoagulation treatment
9. Severe asthma requiring daily treatment
10. Any mechanical complication (e.g. ventricular septal defect, papillary muscle rupture, cardiac tamponade)
11. Atrioventricular block grade III
12. Known inability to undergo MRI investigation

    Permanent pacemaker
    * Pronounced claustrophobia
13. Known intolerance to study drug
14. Known intolerance to adenosine
15. Pregnancy
16. Participation in another investigational drug study
17. Previous randomization in the OPTIMAL-PCI trial
Mixed Methods Feasibility Study of an App for Childhood Obesity Prevention and Management

This evaluation evaluated Health Education England's NoObesity digital health app's usability and acceptability to undertake activities improving families' diet, physical activity and weight. The purpose of the study is to evaluate the app's influence on self-efficacy and goal setting and to determine what can be learned to improve its design for future studies, should there be evidence of adoption and sustainability.


Eligibility Criteria:
Inclusion Criteria:

* adult users (over 18 years)
* fluent in English
* willing to use the app
* parents or legal guardians of a child or children OR health care professionals linked to the parent or guardian
* owner of a smartphone to access the app, with 4G data access

Exclusion Criteria:

* individuals who are known to the researchers or staff at Health Education England
* deaf or hearing impairment
* prior use of the app before study commencement
* refusal to give informed consent
* children, vulnerable young people, or vulnerable adults.
Investigating Safety, Tolerability and Efficacy of AZD5363 in Prostate Cancer.

To investigate the safety, tolerability and anti-tumour activity of AZD5363, as monotherapy, in patients with metastatic Castrate-Resistant Prostate Cancer. AZD5363 will be investigated in patients who have progressed after chemotherapy (Part A) and in patients who have progressed before receiving chemotherapy (Part B).

Recruitment into Part A, Group 1 has been suspended. A new design for this group is currently being evaluated. Part A, group 2 patients (progressed after 1 or more 2nd generational anti-hormonal therapies) will receive AZD5363 480mg bid intermittently (4 days on/3days off).

Part B will only start if there is evidence of anti-tumour activity along with AZD5363 having an acceptable safety profile in Part A. Part B will be conducted in pre-chemotherapy patients on a dose and schedule selected from Part A.

A Phase Ib Multicentre Study of AZD5363 Monotherapy to Assess Anti-Tumour Activity, Safety, Tolerability, and Pharmacokinetics in Patients With Metastatic Castrate-Resistant Prostate Cancer (mCRPC) (PYRUS)

Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent
* Males aged 18 years and older
* Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features for which no standard therapy is currently considered appropriate
* Documented evidence of Metastatic Castrate-Resistant Prostate Cancer (mCRPC)
* Part A: Patients must have received prior docetaxel-based chemotherapy for mCRPC and have a Circulating Tumour Cell score of 5;
* Part B: Patients must have progressed before receiving any chemotherapy for mCRPC;

Exclusion Criteria:

* Any prior exposure to agents which inhibit AKT as the primary pharmacological activity
* Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection including hepatitis B, hepatitis C, and human immunodeficiency virus
* Spinal cord compression or brain metastases unless asymptomatic, treated, and stable and not requiring steroids
* Clinically significant abnormalities of glucose metabolism
* Major surgery within the previous 4 weeks