cyrilzakka/clinical-trials huggingface dataset:
Competencies of Operating Room Nurses and Influencing Factors

Aim: The aim of this study was to determine the perceived competence of operating room nurses and the opinions of the surgical team, regarding the competence of nurses and the influencing factors with a deep understanding.

Method: This convergent parallel mixed-methods study was carried out with members of the surgical team working in 17 hospitals including three public, two university, one city, one education and research, and ten private ones located in city center of Burdur, Isparta and Antalya provinces. The data were collected between May 1th, 2020 and August 20th, 2020 using Quantitative and Qualitative Personal Information Forms, Perceived Perioperative Competence Scale (PPCS-R) and semi-structured interview form. The quantitative data were assessed using the SPSS 24.0 package program, and the qualitative data were assessed using content analysis and thematic analysis. The quantitative and qualitative data were analyzed independently, and interpreted based on analytical generalization in the discussion section.

Aim: The aim of this study was to determine the perceived competence of operating room nurses and the opinions of the surgical team, regarding the competence of nurses and the influencing factors with a deep understanding.

Method: This convergent parallel mixed-methods study was carried out with members of the surgical team working in 17 hospitals including three public, two university, one city, one education and research, and ten private ones located in city center of Burdur, Isparta and Antalya provinces. The sample of the quantitative dimension of the study consisted of 224 operating room nurses working in authorized institutions, and the qualitative dimension consisted of 54 team members including 21 operating room nurses, 21 surgeons, 3 anesthesiologists, and 9 technicians/operators. The data were collected between May 1th, 2020 and August 20th, 2020 using Quantitative and Qualitative Personal Information Forms, Perceived Perioperative Competence Scale (PPCS-R) and semi-structured interview form. The quantitative data were assessed using the SPSS 24.0 package program, and the qualitative data were assessed using content analysis and thematic analysis. Quantitative data were analyzed using descriptive analysis, ANOVA, Mann Whitney U and Kruskal-Wallis H tests. Qualitative data were assessed through descriptive content analysis. The quantitative and qualitative data were analyzed independently, and interpreted based on analytical generalization in the discussion section.

Eligibility Criteria:
Inclusion Criteria:

* Quantitative At least six months of operating room experience nurses Qualitative At least six months of operating room experience surgical team members

Exclusion Criteria:

Willingness to withdraw from the study at any time
Biomarker for Alport Syndrome (BioAlport)

International, multicenter, observational, longitudinal monitoring study to identify biomarker/s for Alport syndrome and to explore the clinical robustness, specificity, and long-term variability of these biomarker/s

Alport syndrome (AS) is a progressive hereditary glomerular disease with the prevalence 1 in 50,000. AS is caused by pathogenic variants in the COL4A3, COL4A4, and COL4A5 genes encoding type IV collagen α3, α4, and α5 chains, respectively. There are three modes of inheritance: X-linked Alport syndrome (XLAS), autosomal recessive AS (ARAS), and autosomal dominant AS (ADAS).

Alport Syndrome causes progressive kidney damage. The glomeruli and other normal kidney structures such as tubules are gradually replaced by scar tissue, leading to kidney failure. Boys with Alport Syndrome, regardless of the genetic type, eventually develop kidney failure. These boys often need dialysis or transplantation during their teenage or young adult years, but kidney failure can occur as late as 40-50 years of age in some men with Alport Syndrome. Most girls with the X-linked type of Alport Syndrome do not develop kidney failure. However, as women with Alport Syndrome get older the risk of kidney failure increases.

Currently, diagnosis of Alport Syndrome relies on careful evaluation of the patient's signs and symptoms, along with the family history. Hearing and vision should also be tested. The evaluation can also include a blood test, urine tests, and a kidney biopsy to determine Alport Syndrome. A genetic test is crucial to confirm the diagnosis and determine the genetic type of Alport Syndrome.

There is no cure for Alport syndrome; however, symptomatic treatment can help relieve symptoms. Kidney transplantation is usually very successful in people with Alport Syndrome and is considered the best treatment when end-stage kidney failure is approaching.

The aim of this study to identify biomarker/s for Alport Syndrome and to explore their clinical robustness, specificity, and long-term variability, in the attempt to offer access to earlier diagnosis and treatment monitoring.

Eligibility Criteria:
INCLUSION CRITERIA

* Informed consent is obtained from the participant or the parent/ legal guardian.
* The participant is aged between 2 months and 50 years
* The diagnosis of Alport Syndrome is genetically confirmed by CENTOGENE

EXCLUSION CRITERIA

* Informed consent is not obtained from the participant or from the parent/ legal guardian
* The participant is younger than 2 months or older than 50 years
* The diagnosis of Alport Syndrome is not genetically confirmed by CENTOGENE
Agreement Between Venous and Arterial Blood Gas Measurements in the Intensive Care Unit

The purpose of this study is to examine the agreement between venous blood gas and arterial blood gas measurements in patients in the Intensive Care Unit.

Venous blood gas analysis may be an alternative to arterial blood gas analysis for acid-base status, reducing the need for frequent invasive arterial sampling. The objective of this study is to examine the agreement between ABG and VBG samples for all commonly used parameters (pH, pCO2 and bicarbonate) in a pathologically diverse ICU patient population, specifically analyzing multiple paired arterial and venous samples from each patient.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients 18 years or older
* Admitted to the Intensive Care Unit (ICU)
* Determined by their treating clinicians to require both a central venous line and arterial line

Exclusion Criteria:

* None
L-PRF in Alveolar Ridge Preservation

The effect of leucocyte- and platelet-rich fibrin (L-PRF) for enhancing the healing after dental extractions is still a matter of debate. The available literature suggests that L-PRF performs positive effect to improve alveolar preservation resulting in less bone resorption on extraction sockets. L-PRF is a second generation of platelet concentrate produced without biochemical blood manipulation. L-PRF is composed by three key parameters: first, the presence of platelets; second, the presence of leucocytes; third, the density and complex organization of the fibrin matrix architecture produced by a natural polymerization process. The theory is that this key parameters acts to produce a faster bone healing.


Eligibility Criteria:
Inclusion Criteria:

* (1) Health patients, American Society of Anesthesiologists (ASA) I or II
* (2) Patients who need to submit tooth extraction (pre-molar, canine and incisor teeth - uniradicular teeth or teeth with fused roots) which present ideal conditions to receive dental implants after 3 months.

Exclusion Criteria:

* Smoking
* Systemic diseases related with healing disorders
* Poor oral hygiene
* Pregnant or lactating patient
* Use of flap elevation for dental extraction
A Study to Evaluate [18F]-FDG PET (Fluorodeoxyglucose-positron) in Patients With Pancreatic Cancer (MK-0000-144)

This study will determine whether \[18F\]-fluorodeoxyglucose-positron emission tomography (FDG-PET) can be used to screen for the activity of novel pancreatic cancer treatments.


Eligibility Criteria:
Inclusion Criteria:

* Patient has a diagnosis of Stage IV pancreatic adenocarcinoma with distant metastases
* Patient is scheduled to receive standard chemotherapy containing gemcitabine
* Patient has not received prior systemic therapy for advanced pancreatic adenocarcinoma
* Patient must be available for periodic blood sampling, study-related assessments, and management at the treating institution

Exclusion Criteria:

* Patient has had open abdominal surgery within 6 weeks of the screening visit
* Patient has had radiotherapy to the thorax, abdomen, or pelvis within 6 months of the screening visit
* Patient has an active infection, inflammation, or unresolved bowel obstruction
* Patient has poorly controlled diabetes
Assessing the Impact of Calcium Channel Blockers on COGnitive Function in the Very Elderly (AI-COG)

Older adults are at increased risk of high blood pressure and cognitive decline. High blood pressure itself also increases risk of cognitive decline. A particular type of blood pressure lowering drug (a calcium channel blocker(CCB)) may lower risk of dementia in younger adults but there is no clear evidence of it's impact in those \>=80. It is important that we know whether CCB use impacts on cognitive function in this age group. This study will examine the impact of antihypertensives on change in cognitive function with a particular focus on CCBs.

This study is an observational cohort study examining cognitive change in those participants taking antihypertensives and aged 80 and over and examining cognitive change in participants taking different types of antihypertensive medication.

Eligibility Criteria:
Inclusion Criteria:

Aged 80 and over Receiving pharmacological treatment for hypertension Mini Mental State Exam score \>24 No other condition likely to limit life to less than one year or to prevent the taking of informed consent.

Exclusion Criteria:

Aged under 80 years Not receiving pharmacological treatment for hypertension Mini Mental State Exam score \<25 Diagnosed with a condition likely to limit life to less than one year or to prevent the taking of informed consent.

Presence of a sensory impairment or an existing neuropsychological deficit of sufficient severity to prevent cognitive testing.

Presence of a condition that will prevent cognitive testing, registered blind, profoundly deaf, suffering from an aphasia.
The Safety and Effectiveness of NV-A01 in Glioma Patients

The goal of this clinical trial is to learn about the safety and effectiveness of NV-A01 in the treatment of advanced glioma patients. The main questions it aims to answer are:

1. The safety of NV-A01 in the treatment of advanced glioblastoma patients.
2. The effectiveness of NV-A01 in treating patients with advanced glioblastoma.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with advanced malignant glioma confirmed by histopathology;
2. Patients who have received radiotherapy and/or temozolomide (TMZ) treatment and have residual or recurrent tumors;
3. Patients diagnosed with lesions ≥ 1.0 cm after qualified assessment;
4. KPS score ≥ 60 points;
5. The subjects had informed consent to this study before the experiment and voluntarily signed an informed consent form.

Exclusion Criteria:

1. Patients with unstable central nervous system metastases or meningeal metastases with clinical symptoms, with a risk of brain herniation or severe brain herniation, and judged by researchers as unsuitable for inclusion;
2. Patients with severe cardiovascular diseases, active autoimmune diseases, and other diseases that have been determined by researchers to be unsuitable for enrollment;
3. Patients who have received immunotherapy in the past and have an irAE level ≥ 3, and have been determined by the researchers to be unsuitable for enrollment;
4. Patients with an expected survival period of less than 3 months and judged by the researchers as unsuitable for enrollment;
5. Researchers believe that patients with other serious systemic diseases or other reasons are not suitable for participating in this clinical study.
Salvage Peanut Oral Immunotherapy Study

The purpose of this trial is to study the safety of rescue peanut oral immunotherapy followed by the introduction of dietary peanut for patients with peanut allergy who have lost desensitization during a peanut immunotherapy trial.

Salvage Peanut Oral Immunotherapy Study is a single-arm, open label trial of peanut flour oral immunotherapy (OIT) administered for 6 months followed by introduction of dietary peanut for an additional 6 months.

The peanut OIT phase will involve approximately 3 months of dose escalation up to a maintenance dose of 300 mg peanut protein. This is followed by 3 months of daily maintenance dosing with 300 mg of peanut protein. Patients are then transitioned to the dietary peanut phase ingesting common foods containing approximately 300 mg of peanut protein daily.

Safety will be assessed during both peanut OIT and dietary peanut phases with adverse events recorded including gastrointestinal side effects. They will also be monitored for any anaphylaxis or injectable epinephrine administration. Data regarding compliance with peanut OIT will be collected as well.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have completed an immunotherapy trial for peanut allergy within the last 6 months and are unable to tolerate ≥ 300mg of peanut.
* Age 1-65 years of either sex, any race, any ethnicity. Written informed consent from patient or parent/guardian (if \< 18 years) with participant's assent.

Exclusion Criteria:

* Current participation in an interventional study for peanut allergy
* History of a severe anaphylactic reaction to peanut, defined as hypoxia, hypotension, or neurologic compromise (cyanosis or SpO2 ≤ 92% at any stage, hypotension, confusion, collapse, loss of consciousness, or incontinence)
* Eosinophilic or other inflammatory (e.g. celiac) gastrointestinal disease
* Severe asthma (2007 NHLBI Criteria Steps 5 or 6 , Appendix 2)
* Use of B blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers
* Significant medical condition (e.g., liver, kidney, gastrointestinal, cardiovascular, hematologic, or pulmonary disease) which would put the subject at risk for induction of severe food reactions.

Pregnancy or lactation.
Continuous Positive Airway Pressure on Tuberculosis Pleural Effusion

Tuberculosis (TB) remains as an important public health problem worldwide. Pleural tuberculosis is the most prevalent form of extrapulmonary presentation in immunocompetent patients.

The volume of effusion in the pleural space of patients with pleural TB may cause complications like restrictive ventilator lung functional disturb and/or pleural thickening. The respiratory physiotherapy can be adjuvant on treatment of pleural effusion tuberculosis throughout of various treatment technique.

The Continuous positive airway pressure (CPAP) is utilized in various pathologic, this improves lung mechanics by recruiting atelectatic alveoli, improving pulmonary compliance, and reducing the work of breathing.

The aim of this study is to determine the effect of CPAP on fluid absorption among patients with pleural effusion due tuberculosis.

This randomized and controlled trial compared the reduction of the pleural effusion volume of the group of patients using the anti-TB standard regimen to that using the anti-TB standard regimen AND adjuvant treatment of physical therapy during four weeks.

* Control group: The patients received rifampicin, isoniazid and pyrazinamide daily(anti-TB standard regimen)
* Interventional group: The patients received anti-tb standard regime and Continuous Positive Airway Pressure (CPAP) 3 times a week for 30 minutes with positive expiratory end pressure of 10 cmH2O.

Evaluation of the pleural effusion size: a helicoidal thoracic computed tomography (CT) was carried out in all patients enrolled. The valuation was conducted by two radiologists blinded for the treatment used, specifically trained for the purpose of the study.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of pleural tuberculosis.
* Patients 18 years of age and older.

Exclusion criteria:

* Be under previous treatment of respiratory physiotherapy.
* Irregular use or abandonment of the anti-TB standard regimen.
* To fail one or more physiotherapy section.
* To fail one or more radiological evaluation.
Study to Evaluate Cognitive Functioning in Remitted Depression During Treatment With Fluvoxamine

Open label, non-comparative, prospective study to evaluate cognitive functioning in remitted depression outpatients during long-term preventive treatment with Fluvoxamine (Fevarin®)


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of recurrent depressive disorder at least two years prior to enrollment into the study.
2. At least two severe depressive episodes with or without psychotic symptoms in the past medical history.
3. Stable patient in remission since at least 4 weeks after depressive episode and not more than 6 months after depressive episode.
4. Planned prescription of fluvoxamine for preventive therapy in recurrent depressive disorder.
5. The subject is fluent in Russian language.
6. According to Stroop test one of following points has to be met - increase of the words reading time on 10% and more or three and more mistakes done.
7. Sum of Addenbrooke's Cognitive Examination total scores must be 93 or less.
8. Male or female, between the ages of 18 and 65 years.
9. If female, postmenopausal or birth control.

Exclusion Criteria:

1. Diagnosis of the following concomitant psychiatric disorders: current depressive or maniac episode, bipolar affective disorder, persistent mood affective disorder (cyclothymia, dysthymia, other or unspecified persistent mood disorder), other or unspecified mood affective disorder, substance-related disorders, schizophrenia, or other psychotic disorders.
2. History of a drug or alcohol disorder.
3. Current treatment with fluvoxamine.
4. History of depressive disorder associated with endocrine disorders.
5. Pregnancy, breast-feeding female patients.
6. History of any significant neurologic disease.
7. Treatment with electroconvulsive therapy in the 6 months preceding the study.
8. Major risk of suicide.
9. Hypersensitivity to fluvoxamine.
10. Use of the medications, which are known to interact with fluvoxamine.
11. Have initiated psychotherapy or other therapies (such as acupuncture or hypnosis).
12. Have initiated cognitive remediation therapy within 12 weeks prior enrollment or at any time during the study.
the Effect of Isosorbide Mononitrate in Reducing Pain During Cooper Intrauterine Device Insertion

The aim of the study is to evaluate the efficacy of isosorbide mononitrate vaginal administration in reducing pain during copper IUD insertion in nulliparous women


Eligibility Criteria:
Inclusion Criteria:

* nulliparous women requesting copper IUD device insertion

Exclusion Criteria:

* parous women, contraindications to IUD insertion, allergy or contraindication to isosorbide mononitrate, uterine anomaly
Role of Dietary Habits in Efficacy of Bariatric Surgery - Study B

The purpose of the study is to compare dietary habits after bariatric surgery in patients with poor weight loss versus good weight loss outcomes.

The obesity epidemic is a major public health concern with a significant economic burden in the USA. Bariatric surgery is the most effective and durable weight loss treatment, with long-term cardiometabolic health benefits. Among different types of bariatric procedures, sleeve gastrectomy (SG) has become the most commonly performed in USA. While SG is expected to result in a 50-60% excess weight loss, inter-individual differences in weight loss are large and approximately 25% of patients can be considered poor weight-loss responders who either do not lose a substantial amount of weight or regain the lost weight afterwards. The mechanisms underlying this clinical variation remain unknown and interventions to improve on these outcomes critically lacking. Of interest, altered daily dietary habits are experienced by a substantial proportion of bariatric surgery candidates, raising the question whether such alterations may contribute to inter-individual differences in weight loss success. Therefore, the purpose of the study is to compare dietary habits after bariatric surgery in patients with different weight loss outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Bariatric surgery (sleeve gastrectomy) patients

Exclusion Criteria:

* Insulin-dependent diabetes
* Anemia
* Smoking
* Shift work within the past 1 year
* Drug or alcohol dependency
* Bipolar disorder
* Post traumatic stress disorder (PTSD)
Plasma Concentration of Somatostatin and Endocannabinoids After GA and RA in Upper Extremity Trauma Surgery

The application of RA can decrease the central sensitization and chronic pain after trauma surgery. The plasma concentrations of somatostatin and fatty acid amides were not studied up to this time in this kind of settings, so investigators believe that this is the first work that shows how upper extremity nerve blockade changes the plasma concentration of somatostatin and fatty acid amides in upper limb surgery in trauma patients.

Total of 100 American Society of Anesthesiologist (ASA) I-III, adult patients scheduled to elective or emergency trauma surgery of hand/forearm or shoulder are planned to be randomly allocated to general anaesthesia (GA) or ultrasound-guided (UG) brachial plexus block (BPB) group, in this randomized-prospective study after approval by the University Research Ethics Board, Pécs University Medical School, Hungary. All of the patients will receive detailed information about the planned BPB or GA techniques and surgeries, then written informed consents will be obtained. Study participants are planned to be assigned randomly into 4 groups (Shoulder GA; Shoulder RA; Hand/forearm GA; Hand/forearm RA).

Standardized UG Axillary-supraclavicular (AX-SC) approach to the BP is planned to be performed under sterile conditions, or standardized GA with propofol IV, fentanyl IV, and 1 MAC (minimal alveolar concentration) sevoflurane, by experienced anesthesiologists.

Blood samples will be taken at 0-time point (straight before the administration of BP injection or the induction of GA) and straight after the surgery. The collected serum samples are stored at -70 °C for a maximum of two weeks prior to analysis. Qualitative and quantitative determination of endocannabinoids and corticosteroids is performed by supercritical fluid chromatography coupled with tandem mass spectrometry after salting-out assisted liquid-liquid microextraction. For somatostatin measurement, the samples are immediately supplemented with aprotinin (20µl/ml blood sample; Gordox 10 KIU/ml (Kallikrein Inhibitor Unit/ml), Richter Gedeon Budapest, Hungary) and transported for centrifugation on ice. The pellet is discarded, and the plasma is stored at -80⁰C until further processing. The somatostatin concentration of the plasma sample is determined with both ELISA (CEA592Hu, Cloud-Clone Corp., Wuhan, PRC) and radioimmunoassay. The results are collected and analyzed.

Demographic data, vital parameters, and verbal numeric rate of pain intensity are collected prior to and after surgery.

Eligibility Criteria:
Inclusion Criteria:

* upper extremity fracture
* surgery of hand/forearm or upper arm
* unpremedicated patients
* scheduled for elective or emergency trauma

Exclusion Criteria:

* psycho-mental conditions interfering with consent or assessment
* the patient refused to participate
* preexisting chronic pain condition
* daily analgesic or sedative or steroid consumption
* sedative or analgesic premedication
* pre-existing neuro-endocrine disorders
* antecedent cancer
* advanced liver or kidney disease.