cyrilzakka/clinical-trials huggingface dataset:
Expert Guided Training Versus Self Learning with Virtual Patients

Virtual patients have increasingly been used in the training of healthcare professionals to enhance critical decision-making skills in emergency patient management education. The aim of this study is to investigate the contribution of the virtual patient simulation used in the education of paramedic students by comparing the effectiveness of self-directed learning with expert-guided learning. Additionally, it is believed that the study will be beneficial for educators responsible for program design who are interested in integrating the case-based learning method with virtual patients into their curriculum.

Virtual patient-based simulation training is increasingly being used in healthcare and medical education to enhance problem-solving and critical decision-making skills. There are two common approaches in these trainings: instructor-led learning and self-directed learning. In instructor-led virtual patient-based simulation training programs, an experienced subject matter expert guides students through virtual patient simulation activities. The instructor provides feedback, support, and encourages discussion and collaboration among students during the training. This approach is beneficial for students who benefit from structured activities and social support in a group learning environment. However, it can be time-consuming, costly, and may not be suitable for every student.

In self-directed learning, the responsibility for learning lies entirely with the student. Students are given access to virtual patient simulations and are encouraged to work through the cases independently. This approach may be more suitable for students who are self-motivated, enjoy autonomy, and have the discipline to work independently. It also offers a cost-effective and flexible option. However, in this approach, the feedback and support needed for skill development are limited to the feedback reports generated by the computer-based virtual patient software program.

In the literature, studies on the use of virtual patient applications in paramedic students' emergency patient management training are limited. This study aims to contribute to educators who use or plan to use virtual patient simulation by comparing instructor-led virtual patient-based simulation training with self-directed virtual patient-based simulation training to determine which approach is more effective in enhancing students' critical decision-making skills.

Eligibility Criteria:
Inclusion Criteria:

Volunteer 4th-semester paramedic students from the Department of Vocational Health Sciences at the University

Exclusion Criteria:

Previous experience with the same clinical scenarios
Transcorneal Electrical Stimulation Therapy for Retinal Disease

Transcorneal stimulation may enable neurons to survive degeneration processes via enhanced secretion of neurotrophic substances and direct stimulation of neurons.


Eligibility Criteria:
Inclusion Criteria:

* Retinitis pigmentosa, Macula off, Primary open angle Glaucoma, Hereditary Macular Degeneration, Treated Retina detachment, Retinal Artery Occlusion, Retinal Vein Occlusion, Non-Arthritic-Anterior-Ischemic Optic-Neuropathy, Hereditary autosomal dominant Optic atrophy, dry Age-related Macular Degeneration, Ischemic Macula edema

Exclusion Criteria:

* Severe other disease such as non-proliferative diabetic retinopathy, exudative Age-related Macular Degeneration
* Age above 99 years
Real-life Experience in Brazil in Patients With Castration-resistant Prostate Cancer Treated With Olaparib+Abiraterone

PROCeed is an observational study assessing real world clinical endpoints and demographic characteristics in patients with castration-resistant prostate cancer treated with Olaparib+Abiraterone.

PROCeed is an observational, longitudinal study with prospective data from Brazilian participating sites, so as to generate real-world data. 10 Brazilian oncology sites are estimated to participate in the study. Each site will have participating investigators in charge and a proper technical team who will be in charge of data from each service. For this study, a convenience sample will be adopted, with an expected 2-year recruitment of 80 patients. The protocol was created in Germany and other countries could use it, with the potential for data from other countries to be pooled for analysis.

Recruitment to each subgroup will be monitored every 3 months and feasibility for continued enrolment will be assessed after 1 year of recruitment (at months 3 and 6, recruitment will be evaluated for proper site selection); if \<20 patients have only been enrolled in a particular subgroup after 1 year, the study team will assess feasibility of pooling data from other countries to allow for at least 40 patients in a pooled analysis for that subgroup.

The study plans to recruit patients for no more than 2 years and to follow patients from the start of olaparib to 1 year after last patient inclusion (LPI). Data will be collected from the medical record through an electronic case report form (eCRF). Participating physicians will be responsible for ensuring that all necessary data are collected and entered in the eCRF. Data compilation will be performed by the principal investigator and statistical analysis will be performed by the statistics team appointed by the Academic Research Organization (ARO).

The target sample size of 80 patients in Brazil is based in a 24-month recruitment period. In order to avoid unnecessary imprecision for the subgroup previously exposed to a new hormonal agent, a minimum enrolment of 50% (40 patients) of the total sample size will be imposed for this subgroup. Estimation is determined based on the primary objective of the TTD event-free rate; the main measure of interest is at 6 months for patients previously exposed to NHA and 12 months for patients naïve to NHA. Assuming a 6- month TTD event-free rate is of approximately 50% for patients previously exposed to new hormonal agent, with a sample size of 40 patients in this subgroup, the precision would be +/- 15,5%.

Eligibility Criteria:
Inclusion Criteria:

1. Willing to provide written informed consent;
2. 18 years or older;
3. Documented histology or cytology of PCa, adenocarcinoma;
4. Documented as mCRPC;
5. Olaparib+abiraterone started after the activation of the research site.

Exclusion Criteria:

Patients participating in a clinical trial with investigational treatment for prostate cancer within 30 days before starting olaparib.
Positive Effects of Laser Acupuncture in Methamphetamine Users Undergoing Group Cognitive Behavioral Therapy: A Pilot Study

Methamphetamine (MA) addiction has become a crucial public health issue due to its adverse effects. Acupuncture has been used for drug detoxification for many years. However, some disadvantages are not be suitable for MA users. The advantages of laser acupuncture includes safety, painless, less time consuming and higher acceptability without current investigation. Therefore, investigators arrange this study to evaluate the efficacy of laser acupuncture combined with golden treatment of cognitive group therapy.

Methamphetamine (MA) addiction has become a crucial public health concern because of its adverse consequences to individuals and the society. Manual or auricular acupuncture have been applied in opioid dependence treatment for a long time. Electroacupuncture may also alleviate the symptoms of MA addiction such as psychosis, anxiety, and depression during abstinence. However, several comorbidities are associated with MA use, such as blood-borne infections, decreased the willingness of physicians to perform. The advantages of laser acupuncture (LA) include its safety, painlessness, limited time use, and higher acceptability, making it suitable for treatment of drug users. To investigate the clinical efficacy of laser acupuncture combined with group cognitive behavioral therapy for MA addiction treatment. MA users who participated in group cognitive behavioral therapy and met the inclusion criteria were referred from psychiatrists to participate. The participants received laser acupuncture treatment once a week for 2 months (total eight treatments) on selected acupoints (PC6, HT7, LI4, ST36, SP6, and LR3). Laboratory assessment included urinalysis for MA and liver function tests aspartate aminotransferase, alanine aminotransferase, and γ-glutamyltransferase (AST, ALT, and r-GT), whereas the objective assessment included visual analog scale (VAS) for MA craving and refusal and Pittsburgh sleep quality index (PSQI), Beck Anxiety Inventory (BAI), and Beck Depression Inventory (BDI) questionnaires. All data were collected before and at 1 and 2 months after treatment. Cognitive behavioral therapy completion rate and rate of relapse to MA use were also determined.

Eligibility Criteria:
Inclusion Criteria:

* subject must be aged ≥20 years, with full understanding of the content of the study and who signed a consent form
* subject must be diagnosed as MA use disorder by a psychiatrist according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V)
* subject must participate in cognitive behavioral therapy

Exclusion Criteria:

* subject received manual acupuncture or LA treatment in the preceding month
* subject had cancer, stroke, myocardial infarction, or major trauma
* subject demonstrated obvious suicide intention
* subject were pregnant
* subject were HIV-positive
Validation of the TheraSure CNI-Monitor Under Immuno-checkpoint-therapy (hereinafter: "immunotherapy") in NSCLC in Palliative Therapy

This is a prospective, non-interventional, national study planned at three centers for patients with non-curative NSCLC receiving immunotherapy.

At present, PD-L1 expression or tumor mutation burden serve as surrogate parameters for response to immunotherapy. However, the problem for clinicians is that not all patients with positive findings respond to this form of therapy.

Cell-free DNA (cf-DNA) can be detected in blood plasma. Tumor cells almost always have chromosomal instabilities (or "copy-number variations" (CNV)), which can be detected using next-generation sequencing (NGS), also in the cf-DNA. These CNV can be quantified and given as a cf-DNA copy number instability score (CNI value). TheraSure CNI-Monitor is a highly sensitive method that can detect as little as 0.5% tumor DNA in plasma.

In preliminary work in a cohort of 56 patients with various types of cancer (including: breast, colon, lung, ovary, melanoma) in advanced stages, the TheraSure CNI monitor was already evaluated in the monitoring of immunotherapy. In 51 of the 56 patients, increased CKD values were measured before the start of therapy compared to a normal group of 126 individuals. To predict the success of the therapy, further blood samples were used after the first and second therapy cycle and threshold values were set for the minimal expected decrease in the CNI value in the event of therapy response. A therapy failure could be predicted with a high positive predictive value, cases of hyperprogression could be detected earlier than by routine imaging. In addition, pseudoprogression could be distinguished from true progression using the CNI value.

The CNI monitor on cell-free DNA is to be used prospectively in 170 patients. The primary objective of the study is the prediction of primary progression under immunomonotherapy (defined as PD within 6 months after RECIST) with a predictive value for progression (PPV) of ≥50%.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form
* Age ≥18 years
* NSCLC, non-curatively treatable stage III or stage IV with palliative treatment indication
* Immunocheckpoint-therapy for malignant disease (Immunotherapy as monotherapy, double immunotherapy or combination with chemotherapy)

Exclusion Criteria:

* Person is unable to understand the nature, importance and scope of the clinical trial
* Participation in an interventional study
* Hb value \<9g/dl
GELSECTAN® and Covert Hepatic Encephalopathy

Randomized crossover pilot clinical trial in which 10 cirrhotic patients with covert hepatic encephalopathy (CHE) will be assigned to take GELSECTAN® (TID) or placebo for 30 days. After a washout period of 15 days, the treatment branches will be interchanged.

The objective of the trial is to obtain pilot variances to design a phase II trial, in which the efficacy of the treatment will be tested. As an exploratory objective, the efficacy of the product in the treatment of covert hepatic encephalopathy will be analyzed.

Main endpoint Improvement in CHE after 30 days of treatment with GELSECTAN®, measured by the Psychometric hepatic encephalopathy score (PHES)


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 85 years.
2. Liver cirrhosis defined by a previous liver biopsy or by clinical data.
3. Presence of minimal hepatic encephalopathy (MHE) defined by two psychometric methods (PHES and / or S-ANT and / or Sloop-test).
4. Adequately informed patients who grant their written consent to participate in the study.

Exclusion Criteria:

1. Alternative neurological diagnosis.
2. Hepatic encephalopathy stage ≥2 using the adapted West-Haven scale.
3. Terminal disease. At the discretion of the doctor, where the patient is in an irreversible situation, in which hepatic encephalopathy is a final manifestation.
4. Presence of Acute-on-chronic liver failure defined by the presence of decompensated liver cirrhosis with severe organ or multi-organ failure.
5. MELD score greater than 25 at the time of inclusion.
6. Hospitalization for any reason.
7. Neurological or psychiatric comorbidity that makes the evaluation of hepatic encephalopathy difficult. This includes patients with mental illnesses (dementia, cerebrovascular disease with sequelae, Parkinson's disease, schizophrenia).
8. Active digestive bleeding. Before inclusion, there must have been a 48-hour period without signs of bleeding.
9. Patients with hypersensitivity or allergy to any of the components of GELSECTAN® (grape, pea).
10. Clinical situations in which the administration of oral feeding is contraindicated.
11. Active oncological processes, including hepatocarcinoma.
12. Active infection of any origin.
13. Acute renal failure (AKI). Defined by the current diagnostic criteria of the KDIGO group (Kidney Disease Improving Global Outcomes).
14. Dehydration Diagnosed by physical examination of the patient.
15. Severe hyponatremia. Defined by plasma sodium \<130 mEq / dl.
16. Concomitant use of sedative drugs, such as benzodiazepines, morphic or derivatives (methadone, tramadol ...)
17. Active drug and/or alcohol use. In each case of clinical suspicion of drug use, an analysis of toxins in urine will be carried out, which includes cocaine, cannabis, opiates. All patients with confirmed alcohol consumption greater than 3 UBD in men or 2 UBD in women will be excluded.
18. Consumption of drugs currently indicated for the treatment of HE: Lactulose, lactitol and antibiotics.
19. Participation in another clinical trial
Role of Inhaled Nitric Oxide in Vascular Mechanics and Right Ventricular Function

The aim of this study is to evaluate the role of nitric oxide on pulmonary vasculature and right ventricular function in postoperative cardiac surgery patients.

This study will evaluate modifiable pathophysiological treatments for postoperative pulmonary hypertension and right ventricular dysfunction.

One pharmacological, inhaled nitric oxide, and one non-pharmacological, the OLA strategy combining lung recruitment and stabilization with individually optimized positive end-expiratory pressure (PEEP) and the possible synergistic effects of both interventions on right ventricular performance. Apart from acting specifically on the pathophysiological mechanisms described, the combination of an OLA strategy and iNO may be particularly beneficial, as modification of pulmonary status by OLA may, in theory, enhance the effects of iNO by significantly increasing gas exchange area and thus alveolar ventilation.

A number of closely related physiological variables will also be studied to better characterize the effects of both strategies and their combination. This may help to better establish the indication for iNO in cardiac surgery patients and improve our understanding of mechanisms that are also present in ARDS patients, albeit on a different scale.

This is a prospective randomized controlled physiological prospective study to be performed in two hospitals. The intervention period is limited to the first 2 -3 hours postoperatively. A total of 54 patients will be recruited.

Eligibility Criteria:
* Age \> 18 years
* Under controlled mechanical ventilation in passive conditions
* Presence of postoperative lung collapse (confirmed by pulmonary echocardiography and Air test)
* Preoperative left ventricular ejection fraction (LVEF) ≥ 30%.
* Absence of hypovolemia: absence of "kissing" ventricles and/or collapsibility index of the superior vena cava \< 20%.
* Stable spontaneous heart rhythm
* Postoperative hemodynamic stability:
* Mean arterial pressure (MAP) ≥ 60 mmHg
* Central venous pressure (CVP) ≥ 10 mmHg
* Heart rate (HR) ≤ 100 bpm without tachyarrhythmias
* Lactic acid ≤ 3 mmol/L
* Single vasopressor treatment
* Norepinephrine dose ≤ 0.2 μg/kg/min, without an increase ≥ 15% in the last 30 -minutes.

Obtained informed consent
A Study of Neoadjuvant Atezolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Patients With Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer (IMpower030)

This is a randomized, double-blinded study designed to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of neoadjuvant treatment with atezolizumab (MPDL3280A) or placebo in combination with platinum-based chemotherapy in participants with resectable Stage II, IIIA, or select IIIB non-small cell lung cancer (NSCLC) followed by open-label adjuvant/postoperative atezolizumab or best supportive care and monitoring.


Eligibility Criteria:
Inclusion criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Histologically or cytologically confirmed, resectable Stage II, IIIA, or Select IIIB (T3N2 only) NSCLC of squamous or non-squamous histology. Staging should be based on the 8th edition of the AJCC/UICC staging system
* Evaluation by an attending thoracic surgeon to confirm eligibility for an R0 resection with curative intent
* Adequate pulmonary and cardiac function to undergo surgical resection
* Measurable disease as defined by RECIST v1.1
* Adequate hematologic and end organ function
* Negative HIV test at screening
* Negative for active HBV and HCV at screening
* Adequate tissue for PD-L1 IHC assessment

Exclusion criteria:

* NSCLC with histology of large cell neuroendocrine carcinoma or sarcomatoid carcinoma
* Mixed NSCLC and small cell lung cancer histology
* Any prior therapy for lung cancer
* Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated expected curative outcome
* Non-squamous NSCLC histology with activating ALK and EGFR mutation
* Pregnant or lactating women
* History of autoimmune disease
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or evidence of active of active pneumonitis on screening chest Computed Tomography (CT) scan
* Prior treatment with cluster of differentiation 137 (CD137) agonist or immune checkpoint blockade therapies, anti-programmed-death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibody
* Severe infection within 4 weeks prior to randomization
* Significant history of cardiovascular disease
JSKN033 in Chinese Subjects with Advanced Malignant Tumors

This is a phase I/II multicenter study to evaluate the safety and efficacy of JSKN033 in Chinese subjects with unresectable locally advanced/metastatic solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Be able to understand informed consent form, voluntarily participate and sign informed consent form.
2. Age ≥18 year (at the time consent is obtained), male or female.
3. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
4. Has a Life expectancy ≥3 months.
5. Has a pathologically documented advanced/unresectable or metastatic solid malignant tumor that is refractory to or intolerable with standard treatment.
6. Has at least 1 measurable lesion at baseline according to RECIST 1.1 criteria.
7. Must have adequate organ function prior to the start of JSKN033.
8. Negative urine/serum pregnancy test for females of childbearing potential who are sexually active with a non-sterilized male partner.

Exclusion Criteria:

1. Has clinically active brain metastases.
2. Previously received any other investigational drug within 28 days prior to enrollment.
3. Previously received local palliative treatment within 14 days prior to enrollment.
4. Previously received major surgeries within 28 days prior to enrollment.
5. Need to receive continuous administration of corticosteroids or immunosuppressants for 7 days within 14 days prior to enrollment.
6. Previously received live vaccine within 28 days prior to enrollment.
7. Previously received antibody conjugate drug with topoisomerase I inhibitor.
8. Has a history of other primary malignant tumors within 5 years prior to enrollment.
9. Has uncontrolled comorbidities as specified by the protocol.
10. Has a history of interstitial pneumonia/lung disease requiring systemic hormonal therapy, or suspected interstitial pneumonia/lung disease that cannot be ruled out by imaging during screening period.
11. Subjects with uncontrolled large serous cavity effusion or moderate to large serous cavity effusion requiring repeated drainage (recurrent within 2 weeks after intervention) such as pleural effusion, pericardial effusion, ascites, etc.
12. Toxicities of previous antitumor therapy did not resolve to grade 1 defined by CTCAE v5.0.
13. Has a history of life-threatening anaphylaxis or known hypersensitivity to any component or excipient to the study drug.
14. Has a history of allogeneic bone marrow or organ transplantation.
15. Pregnant or breastfeeding female patients.
16. Other conditions that the investigator considers unsuitable to participate in this clinical trial, including but not limited to psychiatric disorders, alcoholism or drug abuse, etc.