cyrilzakka/clinical-trials huggingface dataset:
Effectiveness and Suitability of the Online Mobile Application for the Mental and Physical Health of Cancer Patients

In this study, the researchers will examine the effects of a mental health supportive online mobile application called MOÚ MindCare to self-reported values of stress, anxiety, depression, emotion regulation, personality traits, rumination and reflection, sleep disturbance, fatigue, and severity of somatic symptoms in a sample of patients with cancer.

Background: Promoting the mental health of cancer patients is one of the main pillars of comprehensive oncological care. Due to the insufficient capacity of psychotherapists and the mental and physical problems of cancer patients associated with treatment, classical face-to-face mental health support is not always available.

Objectives: 1. To evaluate the impact of online psychological interventions on selected parameters of mental and physical health in cancer patients. 2. To compare which type of psychological intervention is most suitable for which type of oncology patients. 3. To evaluate the moderating roles of intervention adherence and perceived acceptability in the effectiveness of the intervention programs.

Methods: The study design is RCT that includes 4 arms : 1. MBCT (Mindfulness Based Cognitive Therapy) 2. Positive Psychology 3. Autogenic Training 4. Waiting list. Participants will take the 8 week online program via mobile application. Outcomes will be assessed online at, 1) Baseline, 2) Post-intervention (PI), 3) 3 months post PI and 4) 9 months post PI.

Anticipated Findings: Completion of the 8-week online program will lead to the improvement of selected variables of psychological and physical health in oncology patients in comparison with the passive control group. It is expected that programs involving a cognitive component (MBCT-Ca and PP) will be more effective than AT. The investigators expect higher adherence and acceptability to be associated with greater improvement in the outcome variables.

Eligibility Criteria:
Inclusion Criteria:

* Men and women over the age of 18
* Diagnosis of some kind of cancer
* Receiving some form of cancer treatment or finished cancer treatment

Exclusion Criteria:

* Patients without a mobil device ("smart" mobile phone)
* Patients without internet access
* Patients suffering from some psychiatric disorder (Schizophrenia, Bipolar Affective Disorder, personality disorder associated with mood changes, Posttraumatic Stress Disorder, suicide attempt, suicide thoughts, Somatoform Disorder or other medically unexplained symptoms which, due to their severity, prevent the person concerned from daily life
* Patients suffering during the last year from: depression with psychotic symptoms, panic anxiety, repeated hospitalization in psychiatry
Study of Acetazolamide With Temozolomide in Adults With Newly Diagnosed or Recurrent Malignant Glioma

This is a Phase I study that examines the rate of dose limiting side effects in patients with malignant astrocytoma treated with combination acetazolamide (ACZ) and temozolomide (TMZ). Eligible patients must have histologically proven newly diagnosed, O6-methylguanine-DNA methyltransferase (MGMT) methylated WHO grade III or IV astrocytoma and be planning to undergo treatment with standard adjuvant TMZ (after completing treatment with TMZ and ionizing radiation (IR)).

During this study, patients will receive daily oral ACZ with TMZ. During each cycle, ACZ will be started on the day of TMZ initiation and continued for a total of 21 days.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven, newly diagnosed IDH wildtype glioblastoma (GBM) that has a methylated MGMT promoter as assessed by the standardized institutional analysis.
* Patients are eligible if they had a prior low grade astrocytoma and there is subsequent histological evidence of a diagnosis of grade III or IV tumor.
* Patients must be receiving TMZ as part of their standard adjuvant treatment regimen following treatment with TMZ and Radiation.
* Patients must have a Karnofsky performance ≥ 60%.
* Normal organ function as follows:

  * Absolute Neutrophil Count (ANC) ≥ 1.0 x 10\^9/ L
  * Platelets ≥ 100 x 10\^9 / L
  * Hemoglobin ≥ 8.0 g / dL
* Age 18 years or older.
* Kidney function (creatinine level within normal institutional limit, or creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine level above institutional normal).
* Liver function (AST/ALT \<2.5 X institutional upper limit of normal (ULN), Total bilirubin ≤ 1.5 times ULN, INR within 1.5 times ULN (or if receiving anticoagulant therapy an INR of ≤ 3.0 is allowed with concomitant increase in PT or an aPTT ≤ 2.5 × control).
* Women able to become pregnant must have a negative pregnancy test within 30 days of registration.
* Patients must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Prior invasive malignancy that is not low-grade glioma (except non-melanomatous skin cancer or carcinoma in situ of the cervix) unless the patient has been disease free and off therapy for that disease for a minimum of 3 years.
* Active systemic infection requiring treatment, including any HIV infection or toxoplasmosis.
* Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration.
* Systemic corticosteroid therapy, \>8 mg of dexamethasone daily (or equivalent) at study enrollment.
* Pregnant women are excluded from this study, where pregnancy is confirmed by a positive serum beta-hCG laboratory test. Breast-feeding should be discontinued.
* Hypersensitivity to acetazolamide or sulfonamides.
Potential Risk for Bacterial Contamination in Ventilator Systems

Background: Few studies have investigated the difference of bacterial contamination between conventional reused ventilator systems and disposable closed ventilator-suction systems. The aim of this study was to investigate the bacterial contamination rates of the reused and disposable ventilation systems, and the association between system disconnection and bacterial contamination of ventilator systems.

Methods: The enrolled patients used a conventional reused ventilator system and a disposable closed ventilator-suction system, respectively, for a week; specimens were then collected from the ventilators' internal system to evaluate human and environmental bacterial contamination. The sputum specimens from patients were also analyzed in this study.

Results: The detection rate of bacteria in the conventional reused ventilator system was substantially higher than that in the disposable system. The inspiratory and expiratory limbs of disposable closed ventilator-suction system had higher bacterial concentrations than the conventional reused ventilator system. The bacterial concentration in the heated humidifier (HH) of the reused system was significantly higher than that in the disposable system. Positive associations existed among the bacterial concentrations at different locations in the reused and disposable ventilator systems, respectively. The predominant bacteria identified in the reused and disposable ventilator systems included Acinetobacter spp., Bacillus cereus, Elizabethkingia spp., Pseudomonas spp., and Stenotrophomonas (Xan) maltophilia.

Conclusion: Both the reused and disposable ventilation systems had high bacterial contamination rates after one week of use. Disconnection of the ventilator systems should be avoided during system operation for decreasing the risks of environmental pollution and human exposure, especially for the disposable system.

The intubated and mechanically ventilated patients were enrolled from the Intensive Care Unit of Chang Gung Memorial Hospital, Taiwan. The experimental study group was assigned to a disposable ventilator system combined with an auto-filled heated humidifier (HH), a closed suction catheter, and a closed aerosol therapy procedure with a valved T-adaptor. According to clinical commonly used system, the control study group was assigned to use with conventional reused ventilator system, combined with a manually filled HH, an open suction catheter, and a conventional aerosol therapy procedure. Every patient was use above both ventilator systems.

Eligibility Criteria:
Inclusion Criteria:

* the mechanically ventilated patients in the ICU

Exclusion Criteria:

* the sputum culture results of the patients indicated the presence of drug-resistant bacteria, influenza virus, and early extubation.
Prevention of Contrast Induced Nephropathy (NIC) by Intravenous Versus Oral Rehydration

The purpose of this study is to compare the efficacy of oral versus intravenous hydration in the prevention of the contrast-induced nephropathy.

Objective: To compare the efficacy of oral versus intravenous hydration in the prevention of the contrast-induced nephropathy (CIN) in inpatients with different renal function and equal type and volume of contrast.

Methods: The clinical trial will include 324 patients with GFR higher or equal to 30 ml/min who will receive intravenous contrast (Iohexol: 300 mg of l/ml; approximate volume: 120 ml at 2-5ml/second) in the following 12-24 hours. Patients with inclusion criteria, and having previously signed a consent form, will be randomised into 3 groups (intravenous hydration, oral and no hydration). Intravenous hydration will be carried out with bicarbonate 1/6M one hour before the test (3ml/Kg/h) and oral hydration with Casen solution in will be carried out 4 hours before (75 ml/10 kg) the intravenous contrast administration. In relation to the hydrated, it should be pointed out that, the same procedure would have been carried out without the study. The follow-up of renal function will be carried out after measuring creatinine and cystatin C in blood and GFR pre- and 24 hour after the test. It will also determine neutrophil gelatinase-associated lipocalin (N-GAL), IL-8 and F2-Isoprostanes levels in urine and superoxide dismutase activity in erythrocytes, pre- and in different post- test times.

Also, in vitro, the effect of contrast on NADPH-oxidase activity of PBLs isolated from 30 control patients will also be studied (10 patients by each group).

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients
* aged less than 18 years
* provision for the performance of IV contrast (120-150 ml) within 12-24 h.

Exclusion Criteria:

* Nephropathy patients with stage 4-5 according to the classification of Chronic Kidney Disease (CKD) of the U.S. National Kidney Foundation's Kidney Disease Outcome Quality Initiative (NKF-KDOQI). The GFR is estimated by the formula Modification Diet Renal Diseases Study (MDRD).
* Patients undergoing: cardiac catheterization or other proceeding in contrast with the previous week, colonoscopy in 48 hours or have received prior nephrotoxic (aminoglycosides and / or certain chemotherapeutic agents) 24-48 hours before the test or in hours.
Free Fluid Detection with Telementored EFAST

This feasibility study will evaluate the accuracy of telementored eFAST (Extended Focused Assessment with Sonography in Trauma) in detecting abdominal free fluid in patients who have recently undergone liver surgery. The primary goal is to determine how well the remote-guided ultrasound can identify fluid accumulation compared to conventional ultrasound performed by a radiologist. Participants in this study will be examined with ultrasound, supported in real-time by a remote expert, to assess its accuracy and other relevant performance metrics.

The study is designed as a prospective diagnostic trial and involves 40 patients at Oslo University Hospital.

Participants will receive an ultrasound examination shortly after surgery, where a nurse is guided in real-time by a remote expert via teleultrasound. The primary objective is to assess the agreement between the telementored eFAST examination and a conventional ultrasound performed by an on-site radiologist. In addition to diagnostic accuracy, the study will evaluate various performance metrics, including the duration of the telementored versus conventional examinations, network reliability, and cognitive workload using the NASA Task Load Index.

The study will also explore the learning curve associated with telementored eFAST by monitoring the improvement in examination efficiency over time. These metrics will help determine the feasibility of using telementored ultrasound as a reliable diagnostic tool in postoperative care, potentially reducing the need for more resource-intensive imaging modalities and improving patient outcomes through timely decision-making.

Eligibility Criteria:
Inclusion Criteria:

Patients who have undergone laparoscopic liver surgery at the Oslo university hospital and are within 72 post-surgery

Exclusion Criteria:

Allergy to ultrasound gel. Patients colonized with ESBL, MRSA and VRE will be excluded due to infection control. Significant postoperative pain that can exacerbated by probe pressure.
The Impact of Preoperative Anemia on Postoperative Anemia and Related Nutrient Abnormalities After Bariatric Surgery

This study aims to assess the impact of preoperative anemia status on anemia and related nutrient abnormalities 1 year after bariatric surgery.

This study aims to assess the impact of preoperative anemia status on anemia and related nutrient abnormalities (ferritin deficiency, vitamin B12 deficiency, folate deficiency, and low transferrin saturation level) at 1 year after bariatric surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent bariatric surgery (sleeve gastrectomy and Roux-en-Y gastric bypass)
* Age between 16 and 70 years
* Patients who have complete 1-year follow-up data

Exclusion Criteria:

* Baseline renal failure
* Vegetarian
* Postoperative bleeding (it was defined as a drop in hemoglobin levels \> 3 g/dL or a confirmed blood loss requiring treatment after surgery)
Appropriate Medication Use in Dutch Terminal Care

The AMUSE trial is a multicentre stepped-wedge cluster randomized controlled trial where medication optimization of patients with a life expectancy of less than three months is investigated by using CDSS-OPTIMED (a personalized medication advice to attending physicians of patients in the last phase of life) The investigators will include 250 patients, in 7 different study sites across the Netherlands. The primary outcome is an assessment of the quality of life of patients, two weeks after baseline assessment.

Rationale: patients in the last phase of life often use many medications that are continued until shortly before they die. This is partly inevitable, because these patients often experience multiple distressing symptoms. However, for a considerable number of medications currently often used at the end of life, the benefit is debatable, e.g. because they are aimed at the long-term prevention of illness.

Primary objective: to examine whether the use of CDSS-OPTIMED, a personalized medication advice to attending physicians of patients in the last phase of life, contributes to patients' quality of life.

Main study endpoints: the primary endpoint is patients' quality of life two weeks after baseline assessment, as measured by the EORTC QLQ-C15-PAL questionnaire (scale 0 to 100).

Potential risks and benefits associated with participation: the intervention in this trial supports physicians in using available evidence and knowledge when deprescribing medication for patients in the last phase of life. The intervention does not involve experimental treatment or medication. The investigators expect no other risks than known side effects of (stopping) medications. The investigators are aware that the trial population concerns vulnerable people who may experience fluctuating symptoms and levels of suffering across their disease trajectory. The investigators acknowledge the risk of overburdening participants. If patients feel burdened by participating in the study, they are encouraged to indicate that.

Eligibility Criteria:
Inclusion Criteria:

* Patient is 18 years or older and provides informed consent to participate.
* The patient is aware that recovering from his/her disease is unlikely, to be assessed by the attending physician.
* The patient is competent to decide about trial participation
* The patient has a life expectancy of at least two weeks and at most three months, as estimated by an attending physician.

Exclusion Criteria:

* The patient is incapable of filling in a questionnaire (patients may be supported by relatives when filling in the questionnaire).
Adaptation of EDAQ Into Turkish, Examining The Reliability and Validity For People With RA

The aim of the study is to adapt the Evaluation of Daily Activity Questionnaire into Turkish language, and to examine the reliability and validity for people with rheumatoid arthritis.

Patient-Reported Outcome Measures are used in clinical practice and research to identify patients with rheumatic and musculoskeletal conditions' functional problems and evaluate the effectiveness of rehabilitation for these. Most commonly, daily activities in the International Classification of Functioning, Disability and Health (ICF) domains of communication, mobility, self-care and domestic life are assessed. Measurement tools commonly used in rheumatology out-patient clinics and research (e.g., the Health Assessment Questionnaire and the Arthritis Impact Measurement Scales 2 include too few activities to be of use for treatment planning. The Evaluation of Daily Activity Questionnaire was developed in the early 1990s in Sweden to address these problems. It is a patient-reported outcome measure evaluating common symptoms and measuring, in depth, activity limitations in rheumatoid arthritis. Patients normally complete it at home, allowing them time to reflect on their abilities and activity limitations. It normally takes between 25 and 35 min to complete.

Hammond et al have developed an English Evaluation of Daily Activity Questionnaire, which has been linguistically and culturally validated for use in the UK (from the original Swedish version). This was shown to be psychometrically robust for use with patients with rheumatoid arthritis. Subsequently, Hammond et al established the EDAQ's content validity and acceptability and demonstrated reliability and validity in seven other musculoskeletal conditions: ankylosing spondylitis; osteoarthritis; systemic lupus erythematosus; systemic sclerosis; chronic pain; chronic hand/upper limb musculoskeletal disorders; and primary Sjögren's syndrome. These conditions were selected as more often referred to occupational therapy. An EDAQ User Manual is available.

This questionnaire evaluates daily living activities of patients with arthritis and musculoskeletal conditions very comprehensively. Cross-cultural adaptation of the EDAQ into the Turkish language would enable its use in Turkey to identify the daily living activity problems for patients with rheumatoid arthritis. This questionnaire will be directional in clinical and academic studies.

The aim of the study is to adapt the Evaluation of Daily Activity Questionnaire into Turkish language, and to examine the reliability and validity for people with rheumatoid arthritis.

Eligibility Criteria:
Inclusion Criteria:

* Being 18 years of age and older
* A confirmed diagnosis of rheumatoid arthritis
* Able to read, write and understand Turkish

Exclusion Criteria:

* Have cognitive impairment affecting ability to understand and complete the study questionnaire.
* Altered their disease-modifying medication regimen in the last 3 months
* Have another neurological or psychiatric diseases that effects daily living activities
Endoscopic Mini/Less Open Sublay(EMILOS) Repair

Ventral hernias in the midline of the abdominal wall are one of the most frequent diseases in general and visceral surgery worldwide. The optimal operative technique is still in discussion. The traditional techniques are open sublay or transabdominal intraperitoneal onlay mesh (IPOM) repair. In order to avoid the risks -large trauma to the abdominal wall with pain and infection, lesion of intraabdominal organs - a new hybrid technique - small skin incision, wide endoscopic dissection of the retrorectus space with implantation of a large mesh - was developed (EMILOS -Endoscopic Mini/Less Open Sublay).

Long-term results in 174 patients with a ventral hernia of the abdominal wall after EMILOS (Endoscopic Mini/Less Open Sublay) repair.

The worldwide most frequently used surgical techniques to repair ventral abdominal wall hernias are the open sublay operation and the transabdominal IPOM (Intra-Peritoneal Onlay Mesh) technique.

Therefore a special questionnaire was developed to send to the patients to evaluate long-term outcome.

Eligibility Criteria:
Inclusion Criteria

* Patients with clinical diagnosis of primary or secondary hernia in the midline of the abdominal wall
* Defect size must be between 2 and 10 cm in width associated with a weak abdominal wall(rectus diastasis)
* Patient must be suitable for general anesthesia
* Patient must have given informed consent
* Patient must be able to understand the principles of operation
* Patient must agree to be incluuded in a follow-up program and to be documented in Herniamed registry

Exclusion Criteria:

* Patients below 18 years of age
* Patients with a defect size below 2 cm
* Patients presenting with loss of domain
* Patients not be able to tolerate general anesthesia
* Patients presenting with excess skin tissue
Psychosocial Outcomes in Families of COVID-19 ICU Patients

During the first part of the SRAS-COV2 pandemic, families were not allowed to visit the patients in ICU. We know that families can develop "Family-PICS" after their relatives' ICU stay. The aim of the study is to study the psychosocial outcomes of families of patients who were admitted in ICU for COVID-19 during the pandemic. The second objective was to search for any differences in outcomes whether families benefited from video-conferences with the medical team and their relatives or not during the ICU stay.


Eligibility Criteria:
Inclusion Criteria:

* the referent family member of any patient admitted in ICU for COVID-19 during the first part of the pandemic

Exclusion Criteria:

* cognitive disorders
* not French-speaking
* refusal to participate