cyrilzakka/clinical-trials huggingface dataset:
The Effect of Peer Counseling on Nursing Image

The aim of this randomised controlled study was to examine the effect of peer counselling on first-year nursing students' perceptions of nursing image in orientation processes.The H0 hypothesis of the study is that there is no statistical difference between the scores of the image scale towards nursing between the experimental and control groups after the peer-assisted orientation process.

In the study, pre-test data will be collected from the first year students enrolled in the school by using the 'Sociodemographic Data Form' and the 'Image Scale for Nursing Profession'. According to the pre-test results, 108 first-year nursing students who scored 143 points or less from the Image Scale for Nursing Profession will be determined by an independent statistical expert. These students will then be assigned to the experimental (n=54) and control (n=54) groups by simple randomisation method. The students in the intervention group will be randomly grouped with 27 senior nursing students who voluntarily agree to participate in the project to provide peer counseling, and one senior student will counsel 2 first-year students. A 7-week counseling process of 1 hour per week will be applied to 54 students in the intervention group. The research will be finalised by applying the post-test to the control and intervention groups immediately after the intervention.

Eligibility Criteria:
Inclusion Criteria:

The experimental and control group to be included in the study

* Continuing their education in the first year of Mersin University Faculty of Nursing in the 2023-2024 Academic Year,
* Willing to participate in the study voluntarily, signing the informed consent form/written consent form,
* Does not have any cognitive, affective and verbal problems that prevent communication
* It is planned to include nursing students with an Image Scale for Nursing Profession score of 143 and lower.

Exclusion Criteria:

The experimental and control group to be excluded in the study

* Do not wish to participate as a volunteer, do not sign the informed consent form/written consent form
* Have a problem that prevents them from communicating cognitively, emotionally and verbally,
* It is planned to exclude nursing students with an Image Scale for Nursing Profession score of 143 and higher from the study.
The Effect of a Group Exercise Intervention on Balance in People With Knee Osteoarthritis: a Pilot Study

In this study, the investigators want to find out if a 12-week exercise program improves balance in people with knee osteoarthritis.

This study will involve two visits to the School of Kinesiology at the University of the Fraser Valley (Chilliwack campus). Each visit will last approximately one hour. Participants will be asked to fill out questionnaires and complete a balance test. In between visits, participants will complete 12 weeks of an exercise program specifically designed for adults with osteoarthritis. Participants will do the exercise classes twice per week. Classes can be done in person or at home

Each exercise class is 45-minutes long and consists of flexibility, strength, and coordination exercises. In each class there are options to either increase or decrease the intensity of each exercise to cater to varying fitness levels and fluctuating symptoms. Each exercise has an assisted (using a chair for balance), body weight, and resisted (weight or exercise tubing) option. Participants will fill out an exercise diary each week to let the investigators know what days they did the exercise classes, and whether they experienced any changes in their knee osteoarthritis symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Medial compartment knee osteoarthritis, diagnosed from a physician or meeting the American College of Rheumatology Clinical Classification Criteria for Osteoarthritis of the knee
* Pass the Get Active Questionnaire to ensure that they are safe to begin an exercise program

Exclusion Criteria:

i) severe knee trauma, knee surgery, or intraarticular knee joint injections in the previous six months ii) active synovitis iii) concurrent neurological (i.e. Parkinson's disease, Alzheimer's dementia, or polyneuropathy), endocrine (i.e., diabetes mellitus) and/or vestibular disorders which may affect balance iv) chronic disease that may put them at risk during the exercise classes (i.e., history of heart failure, stroke, chronic obstructive lung disease) v) uncorrected visual impairment which may affect balance vi) an inflammatory rheumatic disease (i.e., rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and chronic reactive arthritis)
Gas Exchange Kinetics and Work Load During Exercise

The purpose of this research study is to understand how different kinds of exercise affect the human body and the health of the heart and lungs. For example, some people like to exercise continuously for relatively long periods of time while others like to exercise for short periods of time with rest periods in between. Children tend to exercise in frequent bouts of brief exercise interspersed with periods of rest. Also, some people like running or treadmill exercise while others like to work out on stationary bicycles. To date, standard exercise testing is based on a century-old paradigm used predominantly for adults that involves maximal exercise protocols (cardiopulmonary exercise testing-CPET). Moreover, different but widely used exercise modalities such as cycle ergometer and treadmills are currently impossible to compare in children, and this has limited the clinical and research application of such testing in the pediatric age-range. A major premise of this laboratory is that laboratory testing of cardiopulmonary fitness in children should be based on protocols that mimic naturally occurring patterns of exercise in children, rather than those that have been artificially employed to assess maximal efforts in adults. This research project designed to begin the process of systematically identifying protocols can be best used for children and young adults. Participants will exercise in different protocols on a bicycle ergometer or treadmill. This research could lead to improved and more accurate fitness assessment and pave the way to an improved personalized exercise program in health and illness.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 7-35 years old without any known respiratory, cardiac or metabolic disease
* Determined to be in good health by preparticipation history
* No evidence of disease or disability that would impair participation in an exercise testing
* No chronic prescribed medication

Exclusion Criteria:

* Other limitation which in the eyes of the physician that would preclude ability to perform exercise testing
* Use of illegal drugs or abuse of alcohol
* Pregnancy or breastfeeding
The CHILD Trial: Hypoplastic Left Heart Syndrome Study.

The objectives of this pilot study are to evaluate the feasibility and safety of intramyocardial injection of autologous c-kit+ cells during the Stage II BDCPA operation and to observe effects on clinical outcome including right ventricular myocardial function, severity of tricuspid regurgitation, incidence of serious adverse events, re-hospitalizations, changes in health status, the need for transplantation, or mortality.


Eligibility Criteria:
Inclusion Criteria:

* For inclusion in the study, subjects must meet all of the inclusion criteria:

  1. Subjects with hypoplastic left heart syndrome (all types) requiring Stage I Norwood operation.

     Exclusion Criteria:
* Candidates will be excluded from the study if any of the following conditions are met:

  1. Subjects undergoing the Stage I Norwood operation who do not have HLHS.
  2. Subjects requiring mechanical circulatory support immediately prior to Stage II BDCPA operation (within 5 days).
  3. Parent or guardian unwilling or unable to comply with necessary follow-up(s).
  4. Mother is serum positive for HIV 1/2, hepatitis BsAg or viremic hepatitis C and Treponema pallidum.
  5. Subjects who are unsuitable for inclusion in the study in the opinion of the investigator(s).
Evaluation of TAR Technique in the Treatment of Huge Abdominal Wall Hernia and Large Abdominal Wall Defect With or Without Botox Injection .

Aim of the work In this study, we will evaluate posterior component separation (TAR) technique with or without Botox injection for open huge ventral hernia and large abdominal wall defect repair. The primary outcome will be recurrence while the secondary outcome will be infection, postoperative complications (bleeding and dehiscence), pain score, operative time, hospitalization, need for drain, time for drain removal and pulmonary function test before and after surgery.

This prospective clinical study will be performed on 40 eligible patients admitted to general surgery department at Mansoura University Hospi


Eligibility Criteria:
Inclusion Criteria:

* Adult patient fit for general anesthesia with huge ventral hernia (primary, incisional or recurrent).Any patient with large abdominal wall defect secondary to abdominal wall tumor excision or burst after surgery

Exclusion Criteria:

* Patients who are unfit for general anaesthesia. Poor pulmonary function tests. Pregnant females. Patient younger than 18 years. Immunodeficiency. Patient with psychiatric disease disabling surgical intervention. Patients who refuse to participate in our study.
Development of Variable Volume Automated Mandatory Boluses for Patient-controlled Epidural Analgesia During Labour

A novel epidural delivery regimen was developed: Variable volume automated mandatory bolus (AMB) (VVAMB) will advance individualisation of labour epidural analgesia, by which a larger volume of bolus may contribute to better spread of the local anaesthetics within brief period and thereby reduces the chances of motor blockade that could reduce instrumental deliveries.

Epidural analgesia is the gold standard of pain relief for labour pain. Despite this, up to 50% of parturients continue to experience pain leading to suffering and increased caregiver workload. There is also higher risk of motor blockade found in those receiving epidural analgesia, and these factors is associated with dysfunctional labour requiring obstetric intervention (instrumental delivery). Automated mandatory bolus (AMB) of variable-frequency (VAMB) has been shown to provide better pain relief as compared with conventional patient-controlled epidural analgesia (PCEA) with basal infusion, however its long lockout time per hour is associated with unsuccessful patient bolus requests, with similar motor block to conventional regimens.

The investigators therefore proposes to develop a novel epidural delivery regimen: Variable volume AMB (VVAMB) will advance individualisation of labour epidural analgesia, by which a larger volume of bolus may contribute to better spread of the local anaesthetics within brief period and thereby reduces the chances of motor blockade that could reduce instrumental deliveries. This algorithm development including pilot and clinical trial will compare VVAMB with VAMB regimens, in reducing the incidence of motor block in 216 term women requesting for labour epidural analgesia.

Eligibility Criteria:
Inclusion Criteria:

* Healthy (American Society of Anesthesiologists (ASA) physical status 1 and 2) primiparous parturient at term (≥36 weeks gestation);
* Singleton fetus;
* In early labor stage (cervical dilation ≤5cm);
* Request labor epidural analgesia and able to administer combined spinal epidural analgesia (CSEA) according to protocol.

Exclusion Criteria:

* Non-cephalic fetal presentation;
* Obstetric (e.g. pre-eclampsia, premature rupture of amniotic membranes for more than 48 hours, gestational diabetes on insulin, pregnancy-induced hypertension on medication) and uncontrolled medical (e.g. cardiac disease) complications;
* Have contraindications to neuraxial blockade or have received parenteral opioids within last 2 hours;
* Dural puncture/ suspected dural puncture at initiation of CSEA.
Effect of a Low-calorie and High-protein Diet Specially Rich in Animal Protein Compared to a Low-calorie and High-protein Diet Specially Rich in Plant Protein on Glucose Metabolism in Subjects With Prediabetes or Type 2 Diabetes and Overweight or Obesity.

The aim of the study is to explore the effect of a low-calorie diet rich in protein (with a content of 35% of the total calories of the diet), mostly coming from animal sources (75% of total protein), compared to a hypocaloric diet rich in protein (with a content of 35% of the total calories of the diet), mostly coming from plant sources (75% of total proteins), in subjects with prediabetes or type 2 diabetes and overweight or obesity, on body composition, glucose and lipid metabolisms, after 6 months of intervention.

To achieve the objective, a nutritional intervention study is carried out by randomizing participants to: a) a hypocaloric and high-protein diet (35% of total calories), mostly of them coming from animal sources (75% of total protein); b) a hypocaloric and high-protein diet (35% of total calories), mostly of them coming from plant sources (75% of total protein). The study has a total duration of 6 months and include the assessment of clinical, anthropometric, biochemical and lifestyle parameters, at the beginning of the study and after 3 and 6 months of intervention.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 80.
* BMI between 27.5 kg/m2 and 40 kg/m2.
* Diagnosed as prediabetes or type 2 diabetes according to ADA criteria.
* Informed consent to be signed.

Exclusion Criteria:

* Taking antidiabetic drugs (except for metformin with stable dose in the previous 6 months).
* Taking lipid-lowering drugs in unstable dose in the previous 2 months.
* Taking functional foods (i.e. sterols enriched food) or any other dietary supplement with a significant effect on lipid and glucose metabolism and body weight.
* Uncontrolled type 2 diabetes (i.e. glycated hemoglobin over 8%)
* Any disease that could affect study results (i.e. uncontrolled hypothyroidism).
* Alcohol intake over 30 g/day.
* Pregnancy or breastfeeding.
* Any other condition that investigators consider that could interfere with study outcomes.
A Study to Investigate Efficacy and Safety of Apremilast 30 mg Twice Daily (BID) in Chinese Participants With Moderate to Severe Plaque-type Psoriasis (PsO)

The study aims to evaluate the clinical efficacy of oral apremilast 30 mg BID compared with placebo in Chinese participants with moderate to severe PsO


Eligibility Criteria:
Inclusion Criteria

* Chinese participants aged ≥18.
* Diagnosis of chronic, stable moderate to severe plaque PsO for ≥ 12 months before screening. The participant must have sPGA score ≥ 3, PASI score ≥ 12, and BSA involvement ≥ 10% at both screening and baseline (week 0).
* Participant is a candidate for phototherapy and/or systemic therapy. Exclusion Criteria
* Psoriasis flare within 4 weeks of screening.
* Evidence of skin conditions that would interfere with evaluations of the effect of study medication on psoriasis.
* Prior medical history of suicide attempt at any time in the participant's lifetime before screening or randomization, or major psychiatric illness requiring hospitalization within the last 3 years.
* Participant has a malignancy or history of malignancy or myeloproliferative or lymphoproliferative disease within the past 3 years.
* Active tuberculosis or a history of incompletely treated tuberculosis.
* History of human immunodeficiency virus (HIV) infection.
* Prior treatment with apremilast.
* Female participants of childbearing potential unwilling to use protocol specified method of contraception.
* Female participants who are breastfeeding or who plan to breastfeed.
* Female participants planning to become pregnant.
Study of Satraplatin (JM-216) in Combination With Docetaxel

This is a single center, open-label, non-randomized, Phase I dose finding study of the investigational, oral cytotoxic drug, satraplatin (JM-216), in combination with docetaxel in patients with advanced solid tumors for whom curative therapy is not available. Please refer to the Eligibility Criteria below for key inclusion and exclusion criteria.

PURPOSE: The purpose of this trial is to determine a tolerable dose and schedule for the combination of satraplatin and docetaxel when given to patients with advanced solid tumors.

WHAT IS SATRAPLATIN: Satraplatin is an oral, investigational anticancer drug that is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative chemotherapy measures do not exist or are no longer effective
* Life expectancy of at least 3 months
* Measurable or evaluable disease
* ECOG performance status of \<= 2
* Willingness and ability to give informed consent

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Other chemotherapy treatment less than 4 weeks prior to enrollment
* Treatment with docetaxel or a platinum agent less than 3 months prior to enrollment
* Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational
TACE Combined With PD-1 Knockout Engineered T Cell in Advanced Hepatocellular Carcinoma.

This study will evaluate the safety and effect of transcatheter arterial chemoembolization (TACE)combined with percutaneous transhepatic PD-1 knockout engineered T cell infusion in the Paitents with advanced hepatocellular carcinoma(HCC). Blood and tissue samples will also be collected for research purposes.

This is a clinical study to investigate the safety and effect of transcatheter arterial chemoembolization (TACE) in combination with PD-1 knockout engineered T cells in the Paitents with advanced hepatocellular carcinoma. TACE would block the blood supply of the tumor to achieve ischemic, hypoxic andnecrotic effects. The PD-1 knockout engineered T cells were also prepared from autologous origin using CRISPR Cas9 technology. The patients performed one TACE treatment followed by 3 cycles of PD-1 edited T cells by percutaneous infusion in the peripheral of tumor under the guide of CT every four weeks. The safety and clinical efficacy will be evaluated. biomarkers and immunological markers will be monitored.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with unresectable hepatocellular carcinoma;
2. More than 18 years old;
3. Patients diagnosed with hepatocellular carcinoma by histopathology or imagings;
4. Liver function ChildPugh ≤7 points, Physical strength score ECOG-pts 0-1 points;
5. Maximum tumor diameter ≤10cm, tumor number ≤10, no vascular invasion or extrahepatic metastasis;
6. Other organs of the whole body function well;
7. Sign the informed consent;
8. Passed the review by the ethics committee.

Exclusion Criteria:

1. Less than 18 or more than 70 years old;
2. Lack of autonomous decision-making ability;
3. ECOG score \>2, cachexia or multiple organ failure;
4. Metastases; The tumor was diffuse or metastasized widely and the expected survival time was less than 3 months.
5. Uncorrectable coagulation dysfunction with a history of bleeding; Organ transplant;
6. Patients with severe autoimmune diseases; Iodine contrast agent allergy; High allergic constitution;
7. The main portal vein was completely blocked by cancer embolism, with little collateral vascular formation;
8. Severe infection; AIDS, syphilis infection;
9. T cell lymphoma;
10. Patients with mental illness, severe trauma or other stress conditions;
11. Pregnant or nursing women;
12. Abnormal peripheral blood routine detection;
13. Failing to comply with the study protocol to complete the diagnosis and treatment project; Failed ethics committee review.
Evaluation of the Efficacy, Tolerability, and Patient Acceptance of Dermatix Q for the Prevention and Management of Scars

The purpose of this study is to evaluate the efficacy and patient acceptance of Dermatix Q for the prevention and treatment of scarring.


Eligibility Criteria:
Inclusion Criteria:

* Female or male patients at least 18 years of age
* Patients who are at serious risk of hypertrophic scarring (due to family history, race, recent surgery, etc)
* Able and willing to provide informed consent and likely to complete all study visits
* All Fitzpatrick skin types will be evaluated

Exclusion Criteria:

* Known contraindications to Dermatix or any of its components
* Age of scar is \> 4 months
* Keloid scars (scars with increased fibroblastic activity that has exceeded the boundaries of the original scar)
Excimer Lamp Versus Excimer Laser in Vitiligo Treatment

308 nm excimer lamp and 308 nm excimer laser have both provide interesting results in treating vitiligo. They have the same wavelength but the type of emission of the photons is different. To date there is no direct comparative data concerning these two devices in this indication.

The aim of the study is to make an intra-individual prospective comparison between these two phototherapies.


Eligibility Criteria:
Inclusion Criteria:

* patient above 18
* vitiligo for more than 3 months
* at least 2 vitiligo symmetric patches more than 10cm²
* to read and understand the inform consent
* to have a social security number
* non pregnant for women

Exclusion Criteria:

* pregnant women
* keloids
* history of radiotherapy or skin cancer in the treated areas
* treatment for vitiligo in the past 4 weeks
* phototherapy in the past 12 weeks; history of photodermatosis
* treatment inducing photosensibilization
* immunosuppression
* patient who participated in a study in the past 3 months