cyrilzakka/clinical-trials huggingface dataset:
Interprofessional Advanced Cardiac Life Support Training on Collaborative Skills, Self-Efficacy And Emotion Regulation

The aim of this study is to study the effectiveness of interprofessional advanced cardiac life support (IP-ACLS) training in improving collaborative skills, self-efficacy and emotion regulation among fourth-year nursing students using a prospective, open-label, non-randomized controlled design.

The investigators hypothesized that students who participated in the IP-ACLS training are more likely to have better:

1. collaborative skills
2. self-efficacy
3. emotion regulation.

A total sample size of 120 fourth year nursing students will be used. Subjective measures and objective measure are used. Principal Investigator or trained part-time undergraduate student research assistants will recruit nursing students in scheduled identical sessions. Informed consent will be obtained after an explanation of the nature, purpose, and potential risks of the study according to the information sheet.

Pre-test was conducted before starting the IP-ACLS training on Day 1; post-test 1 was conducted immediately after the IP-ACLS training on Day 2; post-test 2 was conducted 1 month after the IP-ACLS training before or after their scheduled lecture break. The students were asked to complete the self-report questionnaire in approximately 10-15 min before and after 2-day IP-ACLS workshop and 1 month follow-up.

Assessment of Interprofessional Team Collaboration Scale (AITCS), General Self-Efficacy Scale (GSE) and Emotion Regulation Questionnaire (ERQ) were used to measure collaborative skill, self-efficacy and emotion regulation using self-administration.

The Kolmogorov-Smirnov test was used to check whether the scores followed normal distributions. Independent sample t test was used for normally distributed data, whereas Mann-Whitney U test was used for non-normally distributed data to compare the AITCS, GSE and ERQ scores in two groups.

Eligibility Criteria:
Inclusion Criteria:

* National University Singapore 4th year nursing students
* Participate in the IP-ACLS training in Academic Year 2016/2017 to Academic Year 2018/2019
* Obtained informed consent

Exclusion Criteria:

* Serious psychological problems
* Cannot provide informed consent
Pain and Emotional Expression in Children With Autism or Mental Retardation

The purpose of this study is to describe facial, behavioral and physiologic (heart rate) reactivity of children with autism aged 3 to 6 years old, during a painful stimulation (venepuncture). Children will be videotaped before, during and after a venepuncture. Each recording will be rated with the FACS (Facial Action Coding System) and the NCCPC (Non Communicating Children's Pain Checklist).

Children with autism will be matched with children with mental retardation and children without developmental disorder. Matching will be established according the developmental age of children with autism.

Eligibility Criteria:
Inclusion Criteria:

Group Autism:

* Child aged 3 to 6 years old
* Diagnosis of autistic disorder established according a pluridisciplinary staff (ICD-10 criteria, Vineland scales, ADOS, etc.)
* Admitted to children's neuropediatrics or genetics department for a venepuncture

Control group mental retardation:

* Child aged 3 to 6 years old .
* Diagnosis of mental retardation established according a pluridisciplinary staff (ICD-10 criteria, Vineland scales, ADOS, etc.)
* Admitted to neuropediatric or genetic department for a venepuncture

Control group without developmental disorder :

* Child aged 18 months to 5 years old.
* Admitted to pediatrics department for a venepuncture
Safety and Efficacy Study of Intracranially Implanted Carmustine to Treat Newly Diagnosed Malignant Glioma

The purpose of the study is to determine the safety and efficacy of intracranially implanted Carmustine in the treatment of patients with primary malignant glioma.

Malignant gliomas recur mostly 2 cm within originated area. Local therapies therefore become particular important. Gliadel wafer developed in the States and marketed in the developed countries is an example of such treatments. The product in this study, Carmustine Sustained Release Implant (CASANT), is similar to that of Gliadel wafer as for the API(Active Pharmaceutical Ingredient), but different as for drug delivering system. As required, the preliminary clinical studies were conducted in China. Based on the results of phase I/II , 8-10 wafers containing given dose of BCNU will be administered intracranially in this phase III to the tumor resected cavity to investigate the safety and efficacy in the treatment of primary malignant glioma in 236 patients.

Eligibility Criteria:
Inclusion Criteria:

* Confirmation of high grade glioma(WHO III or above)by frozen or squash preparation;
* Patients must be 18 to 70 years old, signed ICF;
* At least 4 weeks after previous chemotherapy (6 weeks since nitrosoureas);
* KPS ≥ 60;
* Unilateral, Supratentorial, solitary lesion and not crossing the midline
* No obvious important organ dysfunction: Hepatic function:Serum total bilirubin ≤1.5 times upper limit of laboratory normal; Aspartate aminotransferase (AST) and/or Alanine aminotransferase (ALT)\<2.5 times upper limit of laboratory normal; Renal function:Serum creatinine ≤1.5 times upper limit of laboratory normal;
* Not Pregnant or lactating for women of childbearing potential.

Exclusion Criteria:

* Underwent cytoreductive surgery(excluded stereotactic biopsy);
* With chemotherapy or brain radiotherapy history;
* Tumor located at ventricular system, Open ventricle tumor cavity postoperatively;
* Concomitant with other life-threatening diseases and with life expectancy \<12 months;
* Allergic to nitrosourea drugs;
* With history of intracranial radiotherapy or implant chemotherapy;
* With serious cardiac, pulmonary, hepatic and renal dysfunction, poor glycemic control;
* Experienced \> 3 times of Large epilepsy within one month preoperatively.
* Investigators thought unsuitable for enrollment.
Bilateral TAP and RS Blocks Using Liposomal Bupivacaine/Bupivacaine vs. Regular Bupivacaine in Laparoscopic Colectomy

This study will be a single center, prospective triple blinded randomized controlled study, comparing the use of liposomal bupivacaine (Exparel) to regular bupivacaine with adjuncts in bilateral mid-abdominal transverse abdominis plane (TAP) blocks for patients undergoing laparoscopic colectomy procedures.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective laparoscopic colectomy surgery to be performed by one of the 4 colorectal surgeons in the study.
* English speaking patients
* Patients with American Society of Anesthesiology (ASA) physical status score I- IV

Exclusion Criteria:

1. Emergency laparoscopic colectomy surgery
2. Patients with distant metastatic cancers (e.g. bone, lung, brain).
3. Scheduled for multi organs resection surgery in addition to colectomy.
4. Patients with contraindications to TAP or RS blocks including but not limited to anatomical abnormality, previous surgical intervention that limits or prevents receiving bilateral TAP blocks (e.g. surgical mesh at the site of TAP or RS block), or infection at the injection site.
5. Current colostomies.
6. History of allergy to local anesthetics.
7. Coagulopathy or coagulation disorder. Also patients who are receiving antithrombotic medications as a contraindication to receiving single shot peripheral nerve blockade as per the most recent American Society of Regional Anesthesiology (ASRA) guidelines.16
8. Weight \< 40 kg, as 40 mL of Bupivacaine 0.25%, or combination of 20 mL of bupivacaine 0.25% with 20 mL of liposomal bupivacaine is greater than the maximal dose allowed, given concern for local anesthetic toxicity.
9. Patients who take long acting opioid medication, or on continuous opioid \> 50 MME per day for at least 30 days within 90 days prior to surgery. Also patients who have chronic pain syndrome with a recent preoperative consultation to the chronic pain service.
10. Patients with current substance abuse, or history of substance abuse within 3 months, this includes any illicit drugs or excessive alcohol consumption as defined 4 or more drinks per day or 8 or more drinks per week for women and 5 or more drinks per day or 15 or more drinks per week for men.15
11. Pregnant, nursing, or planning to become pregnant during the study or within 1 month postoperatively
12. Refusal or lack of providing the study consent
Heart Failure-USB: Prediction and Progression

This retrospective cohort study is to identify triggers of heart failure (HF) development and drivers of HF progression as well as the underlying cardiac disease (phenotype) to identify patients at risk and predict the clinical course of the disease. Data of patients who were hospitalized during the years 2010-2023 with acute coronary syndrome (ACS) and/ or with acute heart failure (AHF) will be collected and analyzed. In a subgroup cohort efficacy and safety of digoxin in patients with acute heart failure triggered by tachyarrhythmia will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized with a primary diagnosis of ACS
* Patients hospitalized with a primary or secondary diagnosis of AHF

Exclusion Criteria:

* Existence of a documented statement of the patient against the scientific use of clinical data
"Real-life" Cohort Study on Patients With Chronic HBV Infection in Jiangsu

Hepatitis B virus (HBV) infection remains one of the most serious health problems worldwide. Patients with chronic HBV infection are at an increased risk for developing hepatic cirrhosis, hepatocellular carcinoma and even death. Although some predictive factors of the outcome of chronic HBV infection were identified, more precisely determine the factors which are associated with the outcome in non-selected patients with chronic HBV infection are still needed. The investigators purpose is to constitute a observational cohort of non-selected Chinese patients to create a database of epidemiological, clinical, biological, virological, immunologic and therapeutic parameters, in order to determine factors associated with the outcome of chronic HBV infection.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic HBV infection (defined as HBsAg positive for at least 6 months)

Exclusion Criteria:

* Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) and/or hepatitis D virus (HDV)
* History of liver transplantation
* History of hepatocellular carcinoma (HCC)
The Precision and Arm-to-Arm Variation of Mechanomyography and Acceleromyography for Monitoring of Neuromuscular Block

The purpose of the study is the examine the precision of acceleromyography and mechanomyography during recovery from a neuromuscular blocking agent and to examine whether there is any difference in monitoring block at the dominant or non-dominant arm. Our hypothesis is that there is no significant difference in neither the precision nor the level of block in the contralateral arms.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-III
* General anesthesia \>1 hour
* Surgery in supine position w. possibility of monitoring the neuromuscular block at both arms (n. ulnaris stimulation/thumb response)
* Written informed content

Exclusion Criteria:

* Neuromuscular disorders, hepatic and renal dysfunction
* Medication expected to interfere with the neuromuscular blocking agent
* Allergy to any medication used during anaesthesia
* Body weight less or exceeding 20% of ideal body weight
* Pregnancy or breastfeeding
Linked Color Imaging Based CMV Diagnosis for Gastric Mucosal Lesions

The newly developed linked color imaging (LCI) system (FUJIFILM Co.) creates clear and bright endoscopic images by using short-wavelength narrow-band laser light combined with white laser light on the basis of BLI technology. This system can obtain bright endoscopic images even at a distant view because LCI has more intense white light than the short-wavelength narrow-band laser light. Short-wavelength narrow-band laser light enhances the vessels on the mucosal surface and the patterns of the mucosa. Therefore, LCI may facilitate the detection of gastric mucosal lesions. Further studies are needed to confirm the clinical utility of LCI.

LCI enhances differences in hue, in the red region of the spectrum, through digital processing. This makes red areas appear redder and white areas appear whiter. Thus, it is easier to recognize a slight difference in color of the mucosa. Based on previous experience, a new LCI based endoscopic diagnosis criteria called CMV (color- microstructure-vessel) criteria has been proposed, which could be used for judging the gastric mucosal lesions. LCI has the advantage of detecting color changes of the mucosa, and this could provide very valuable and useful evidence for making endoscopic diagnosis. In this study, a blinded random controlled clinical trial is designed to further validate the diagnostic value of LCI based CMV criteria for gastric diseases.

Eligibility Criteria:
Inclusion Criteria:

* Above 18 years old patients
* Who agree to participate in the study
* Patients with the indications for gastroduodenoscopy

Exclusion Criteria:

* Patients, who were receiving nonsteroidal anti-inflammatory drugs, pump inhibitors (PPI) or antibiotics in the last 3 weeks.
* Severe uncontrolled coagulopathy
* Prior history of gastric surgery.
* Pregnancy and lactation
Effects of Ketogenic Diet on Triathlon's Performance

The study aimed to verify the effects of 5 weeks of ketogenic diet (KD) on some performance index in long distance triathletes

16 well trained male long distance Triathletes participates in the study (30.65 ± 10.77 years of age), with minimum one year of triathlon competition experience and 8-10 hours of training per week. All subjects had a personal interview made by a registered Medical Doctor about the diet intervention prior to the beginning of the study. Moreover participants were educated about the benefits and limitations of the two different dietary treatments and asked to nominate their preference for, or non-acceptance of, each of these interventions. Thus participants also decided liberally if participate for the diet intervention or not. This choice was decided to prevent any type of dropout in the KD group, considering that a free and conscious choices is better for the adherence on a strict diet like ketogenic diet . Investigators were thus able to allocate the athletes to their preferred treatment, while achieving suitable matching of groups based on age, body mass and aerobic power. All the participants were healthy and injured free, and not consuming a low carbs diet prior to the study. The diet macronutrient percentage distribution was the following: for ND the percentages were 25% of TDC (total daily calories), fat were 20% of TDC and carbohydrates represented the 55% of TDC; for KD the percentages were 68% fat, 26% protein and 6% carbohydrate. In the KD very low carbohydrate foods that simulate carbohydrates taste food like croissants, bread and cracked slices made by Le Gamberi Foods (Forlì, Italy), were used for a better compliance to the dietary intervention. Subjects undertaken an anthropometric test and two different cardiopulmonary tests with a professional cycloergometer (MARCA). The anthropometric measures were taken to evaluated body weight. height and body composition . After the body composition analysis subjects underwent to a maximal cardiopulmonary test (GXT) to evaluate the maximal oxygen consumption (VO2max). The following day subjects performed 60 minutes at 45% of PPO to assess endurance performance at ironman biking race-pace. The day after test session KD group started the KD 5 weeks. The Control Group (S) followed his habitual normo-caloric, balanced diet. The same order and procedures were conducted for testing the subjects post diet intervention. Anthropometric and performance test was conducted in the same order for each subjects and at the same time of the day. Blood ketones were measured each other day to ensure the compliance to KD

Eligibility Criteria:
Inclusion Criteria:

* long distance Triathletes (8-10 hours of training per week), competing in half Ironman or Ironman
* no previous experience of low carbohydrate diet
* more than 3 years of training

Exclusion Criteria:

* recent (less than 6 months) musculoskeletal injuries
* more than 2 months without training in the last 2 years
Psychologically Informed Education Intervention for Adolescents With Atraumatic Lower-Extremity Injuries

This is a randomized prospective study assessing the impact of psychosocial factors on pain and physical performance among adolescents with leg pain. A set of psychosocial surveys assessing activity-related fear, stress, anxiety and depression will be completed by the participants. Participants will then complete self-report questionnaires assessing pain, quality of life and functional ability followed by an assessment of physical activity levels assessed with a wearable activity monitor;. Participants will then be randomized into one of two intervention groups (psychologically-informed video education group and a control group). After participants receive their assigned educational intervention, the self-report questionnaires will be re-administered. Participants with leg pain pain will then complete follow-up assessment of their psychological beliefs, pain, quality of life, physical activity levels, and self-reported functional ability through REDcap at 1 week, 4 weeks, 3 months, 6 months, and 1 year.


Eligibility Criteria:
Inclusion criteria

1. Age between 12 and 17 years
2. Atraumatic lower extremity pain for \>4 weeks

Exclusion criteria

1. Suspicion or evidence of complete tendon or ligamentous tear.
2. Current fracture in the lower extremity.
3. Prior history of surgery in the lower extremity.
4. Neurologic or developmental disorder, which alters lower extremity function.
5. Numbness and tingling in any lumbar dermatome.
6. Red flags present for non-musculoskeletal involvement (bowel/bladder problems, saddle anesthesia, progressive neurological deficits, recent fever or infection, unexplained weight loss, unable to change symptoms with mechanical testing).
Strength and Balance in Gender- and Age-Matched Controls

The purpose of this study is to learn more about balance and strength in an elderly population (60 and older). Data will be compared between controls and the age/gender- matched PD participants in study "The Effects of vitamin D on Balance in Parkinson's disease" (OHSU IRB # 6482). Specifically a t-test will be used to compare total work and total power on leg extension and flexion, composite SOT score conditions 1-3 and 4-6, response strength and latency on MCT, and turn duration from the iMOBILITY between the two groups.

Inclusion Criteria:

* Over the age of 59
* Gender and Age-Matched (within 3 years) of main protocol participants

Exclusion Criteria:

* Parkinson's disease diagnosis
* Significant cognitive deficits.
* Another neurological or orthopedic deficit that in the investigator's opinion would have a significant impact on gait and cognition (e.g. stroke, fracture).

This study involves one visit to Oregon Health \& Science University. The study visit will last approximately 2 hours.

Measurements:

1. The participant's balance will be assessed by having them stand on a platform and completing mental tasks such as naming the alphabet backwards. They will be asked to have their eyes open on some tasks and closed on other tasks. For safety, they will wear a harness like those used by rock climbers.
2. The participant's ability to move and balance will be measured by putting six sensors on their bodies (both wrists, both ankles, chest, and back). Each sensor is about the size and weight of a deck of cards. To measure movement and balance, participants will rise from a chair, walk three feet, turn around, walk back to the chair, and sit down.
3. The participant's strength will be evaluated using a machine that resembles a stationary exercise bike. They will have one leg and foot strapped onto the machine. Participants will then be asked to flex and extend their leg as quickly as possible five times. This will be repeated with the other leg.

Eligibility Criteria:
Inclusion Criteria:

* Over the age of 59
* Gender and Age-Matched (within 3 years) of main protocol participants

Exclusion Criteria:

* Parkinson's disease diagnosis
* Significant cognitive deficits.
* Another neurological or orthopedic deficit that in the investigator's opinion would have a significant impact on gait and cognition (e.g. stroke, fracture).
Comparison of the Effectiveness of Three Different Gargates in Radiotherapy-Associated Oral Mucositis

This study was conducted to compare the effectiveness of thyme honey, saline and sodium bicarbonate solution in the management of oral mucositis in patients with head and neck cancer receiving radiotherapy.

The research was conducted as a randomized controlled clinical trial between January 2020 and January 2022. The sample of the research; Patients who applied to Hospital Radiotherapy Unit, received 50-60 Gy radiotherapy in the oral cavity, had a primary diagnosis of head and neck cancer, had no metastasis, had no complaints about mucositis, were older than 18 years old, spoke Turkish, and agreed to participate, in the study. With the closed-envelope randomization method, 48 patients were included in the sample, 12 patients for each of the saline, sodium bicarbonate, thyme honey, and control groups. The routine protocol of the clinic was applied to the control group. Patients in the intervention group (thyme honey, saline and sodium bicarbonate group) were treated 3 times a day for 6 weeks, in addition to the routine protocol of the clinic; they were asked to gargle with 20 ml of the solution in the group they were randomized to, 15 minutes before, 15 minutes and 6 hours after radiotherapy. Intraoral evaluations were made every week by the responsible physician of the radiotherapy unit, who did not know which group the patients were in (single blind). Study data; Obtained using the Sociodemographic and Disease Data Collection Form, the National Cancer Institute Common Toxicity Criteria v4.03, the Oral Evaluation Guide, and the Washington University Quality of Life Questionnaire. In the study, Chi-square analysis was used for the relationship between two categorical variables, One-way Anova for differences in measurements, Levene test for homogeneity of variance, and Bonferroni analysis to find out from which group or groups the difference originated. Support was received from the Health Sciences University Scientific Research Project Office for the study (2020/029)

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis is head and neck cancer
* To be receiving radiotherapy at a dose of 50-60 Gy in the oral cavity
* Not be metastatic
* OM grade 1 (according to NCI-CTCAE v4.03)
* Be 18 years or older
* Volunteer to participate in the study
* Speak Turkish

Exclusion Criteria:

* Have an autoimmune disease
* Have dental disease
* Using dentures
* Being allergic to thyme honey
* Refusing to participate in the research
* To have received radiotherapy treatment in the 6-month period before the start of the study

Criteria for terminating the study

* The patient's desire to leave the study
* Continuing the treatment in another city
* Interruption or termination of radiotherapy treatment
* Patient's death