cyrilzakka/clinical-trials huggingface dataset:
A Comparative Analysis of the Efficacy of Instructional Videos and Live Demonstrations in Crown Preparation Training for Preclinical Dental Students

finding the optimal balance between traditional live demonstrations and instructional videos remains a subject of ongoing discussion in dental education. Moreover, integrating a hybrid model that combines the strengths of both methods may offer a comprehensive approach to crown preparation training.

Therefore, this study aims to address this ongoing discussion by investigating the relative effectiveness of traditional live demonstrations, instructional videos, and a hybrid model that merges both approaches. Through an evaluation of dental students' satisfaction and performance with video tutorials and hands-on demonstrations, this research endeavors to shed light on how different instructional methods influence knowledge acquisition within the practical environment.

A randomized controlled single-blind trial was conducted at the Department of Prosthodontics, Altamash Institute of Dental Medicine for a duration of 12 months from 12th Jan' 2023 till 11th Jan' 2024.

Prior approval was obtained from the Ethical Review Committee of Altamash Institute of Dental Medicine (AIDM/ERC/01/2023/02). written consent was obtained from all participants, A simple random sampling technique was used for the recruitment of participants. .

a total of ninety-six final-year BDS students were enrolled in the study. Before allocation, all participants attended a comprehensive lecture on crown preparation principles delivered via a PowerPoint presentation. Following the lecture, participants were randomly assigned to one of three groups: Group A (instructional video), Group B (live demonstrations), or Group C (hybrid)

Participants in Group A will view an instructional video, group B will attend live demonstrations.

Participants in Group C received a dual approach, combining instructional video guidance with live demonstrations.

Before the intervention, all participants across the three groups underwent a pretest consisting of five questions. These questions were designed to gauge participants' readiness and perceptions regarding crown preparation training. Responses were recorded using a Likert scale ranging from 1 to 5, where 1 represented "strongly disagree" and 5 represented "strongly agree".

Following the lecture and demonstrations, participants were provided with an assessment questionnaire comprising six questions aimed at evaluating their comprehension and knowledge regarding porcelain-fused-to-metal tooth preparation.

Eligibility Criteria:
Inclusion Criteria:

* Fourth-year students of Bachelor of Surgery who voluntarily agreed to participate were included in the study.

Exclusion Criteria:

* Exclusion criteria include students who do not provide consent, those absent from tutorials, individuals with prior experience in crown preparation, or students with medical conditions affecting participation.
An Observational Study to Assess Longitudinal Variation of Immune Biomarkers in Subjects at Risk for Development of Type 1 Diabetes

This study is conducted in the United States of America (USA). The aim of the study is to assess longitudinal variation of immune biomarkers in subjects at risk for development of type 1 diabetes (T1D).


Eligibility Criteria:
Inclusion Criteria:

* Subjects with general good health as judged by the investigator
* Participant tested positive at above or equal to 99th percentile for one or more of three islet antibodies (GAD (glutamic acid decarboxylase), IA2 (islet antigen-2), IAA (insulin autoantibody))

Exclusion Criteria:

* Any chronic disorder (diabetes at enrolment) or severe disease which, in the opinion of the investigator, might jeopardize subject's safety or compliance with the protocol
* Female of child-bearing potential who is pregnant, breast-feeding, or intends to become pregnant
Monitoring of Cardiac Function With 3-axis Accelerometers

Aim of the study: To validate accelerometers for continuous monitoring of global cardiac function during weaning from cardiopulmonary bypass (CPB) in cardiac surgery.

Hypothesis:

The following hypothesis will be tested: Accelerometer measures are clinical relevant indices of global left and right myocardial performance during weaning from cardiopulmonary bypass.

Model:

The performance of the accelerometer will be tested in a intraoperative setting, during weaning from cardiopulmonary bypass. Accelerometer measures of ventricular systolic and diastolic function will be compared to corresponding measures and indices of ventricular functions by echocardiography and hemodynamic monitoring during a step wise controlled weaning from cardiopulmonary bypass, ensuring precise control of pre- and afterload.

Eligibility Criteria:
The hypothesis will be tested in 20 elective patients.

Inclusion Criteria:

* Significant aortic valvular disease scheduled to undergo cardiac surgery with an estimated extracorporeal circulation time \> 40 min.

Exclusion Criteria:

* Evolving myocardial infarction,
* dyskinetic wall motions,
* cardiogenic shock,
* hepatic dysfunction or esophageal disease.
Preoperative Prediction Model of Pathological Outcomes (Mesorectum Quality and Positive Circumferential Resection Margin) in Patients With Mid-low Rectal Cancer

Elaboration of a preoperative prediction model of the quality of the mesorectum and the involvement of the circumferential margin in patients with mid-low rectal cancer who undergo laparoscopic anterior rectal resection.

In a second phase the investigators will study the utility of the prediction model in classifying patients with high risk of suboptimal quality of mesorectum and/or positive circumferential margin. Patients with high preoperative risk will undergo a transanal total mesorectal excision and patients with low risk a laparoscopic transabdominal mesorectal excision. The investigators finally will compare pathological outcomes ( quality of mesorectum and circumferential margin), survival and recurrence between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Patients directed to laparoscopic anterior rectal resection through a transabdominal or a transanal approach.
* Age ≥ 18 years
* Histology of adenocarcinoma or adenoma
* With or without neoadjuvant chemoradiotherapy
* TNM classification: T2 or T3, any N stage or M stage
* Intention of resection R0

Exclusion Criteria:

* TNM classification: T1 or T4.
* Complicated rectal cancer or emergency surgery.
* Previous major colorectal surgery
Kidney Function in Obese Women

The goal of this clinical trial is to investigate the impact of a 10-week moderate intensity interval walking training (MIIWT) program on kidney function markers in obese postmenopausal women. The main question it aims to answer is:

Does MIIWT improve kidney function markers in this population? Researchers will compare MIIWT (designed to training group) to non-training intervention (designed to control group) to see if the training program works to improve kidney function markers.

Participants in training group will: perform a 10-week MIIWT program, four sessions per week (5 repetitions of 6-min-walking-test (6MWT) at 60-80% of 6MWTdistance measured at baseline, interspersed by 6-min of active recovery between repetitions). Participants in control group will : not perform any physical training and maintain their usual daily activities.

The convergence of the obesity pandemic and the postmenopausal status is likely associated with renal function decline. Regular aerobic training have been shown to prevent adverse health outcomes in obese. The main purpose of this study was to evaluate changes in kidney function markers and white blood cell (WBC) subpopulations in obese postmenopausal women participating in moderate intensity interval walking training (MIIWT). A total of 36 obese postmenopausal women were randomized to MIIWT (CON, n=18) or control group (CON, n=18), four times a week for 10-week. The MIIWT consisted on 5 repetitions of walking for 6-min at 60-80% of the 6-min-walk-test-distance with 6-min of active recovery between repetitions. Before and after the MIIWT, body composition, kidney function markers (serum creatinine \[sCr\], blood urea nitrogen \[BUN\], serum uric acid \[sUA\] and Glomerular Filtration Rate \[GFR\] and white blood cells (WBC) count and its specific subpopulations (neutrophils \[NEU\], lymphocytes \[LYM\], monocytes \[MON\], eosinophils \[EOSI\] and basophils \[BASO\]) were assessed.

Eligibility Criteria:
Inclusion Criteria:

* be aged between 50 and 60 years.
* be postmenopausal (absence of menses \> 12 months).
* present a BMI greater than or equal to 30 kg/m2.
* be free of any special diets in the three months prior to the start of the intervention.
* have a sedentary lifestyle (exercise less than 2 h/week).

Exclusion Criteria:

* Suffering from any cardiovascular/renal/pulmonary/metabolic disease.
* Being under menopausal hormone therapy.
* Presenting any orthopedic limitations interfering the ability to perform the study intervention.
Efficacy and Safety of Omega-3 Lipid Therapy in Pediatric Patients With Parenteral Nutrition-Associated Liver Disease

This pilot study seeks to demonstrate the efficacy of an intravenous lipid preparation high in omega-3 fatty acids (Omegaven) in the treatment of cholestasis in parenteral nutrition dependent patients with short gut syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Patient will be dependent upon parenteral nutrition (PN)
* Patient will have short gut syndrome (loss of \>50% of small bowel)
* Patient's guardian/caregiver provides informed consent for patient to receive therapy
* Pediatric patient ≤ 1 year of age
* Expected PN duration is greater than 30 days
* Direct bilirubin \>2.0 mg/dL measured on two occasions no more than one week apart

Exclusion Criteria:

* Liver dysfunction secondary to cause other than PN verified by standard of care diagnostic procedures and lab work to rule out alternative causes of neonatal cholestasis.
* Any patient in whom Omegaven therapy would be contraindicated, such as an allergy to any seafood product, egg protein, and/or previously established allergy to Omegaven
* impaired lipid metabolism
* severe hemorrhagic disorder
* unstable diabetes mellitus
* collapse and shock, stroke/embolism, recent cardiac infarction, or undefined coma status
Physical and Work Variables in Professional Musicians

In professional musicians there are characteristic diseases. In this area there is no preventive culture and many musicians end their professional careers due to ailments and pathologies that cause the abandonment of the profession or they learn to live and play with pain. It is a very demanding profession that requires many hours of training without respecting the necessary rest, which undoubtedly produces fatigue and muscle overload, neurological disorders, etc. Also, the demands to achieve perfection lead to serious work problems.

Given that it is a profession that suffers from pain and psychosomatic alterations and that is often accompanied by emotional alterations due to work demands, it is necessary to know this problem and to what extent it affects the musician to be able to act from different areas and improve his well-being.

The objective is to know specifically the characteristics of professional musicians, their impact variables, both musculoskeletal and emotional, variables related to the workplace and to evaluate their quality of life.

MATERIAL AND METHODS Subjects. Professional orchestral and band musicians between the ages of 18 and 65.

Study design. Descriptive study to be carried out at the University of Valencia. To do this, a survey will be carried out through an online platform. All participants will sign the informed consent and the study will be carried out in compliance with the data confidentiality guidelines. To start the study, the approval of the Ethics Committee of the University of Valencia will be necessary and it will be included in an international registry.

Evaluation. In the first place, the anthropometric data (age, sex, weight, height) and the characteristics of the sample will be taken through an interview designed for this study that will contain questions about the job and instruments they practice. Subsequently, the subjects will fill in the assessment instruments that include the physical activity they perform, the musculoskeletal alterations, workplace harassment, professional burnout, quality of life and anxiety and depression.

Statistic analysis. The variables will be coded and analyzed using the SPSS v.26 program.

Eligibility Criteria:
Inclusion Criteria:

* active professional musicians

Exclusion Criteria:

* non-active or non-practicing professional musicians
Efficacy of Risk-Stratified Treatment in Newly Diagnosed Infant Leukemia

This clinical trial is an open-label, multicenter, prospective phase 2 clinical trial targeting pediatric leukemia patients of infant age. The goal is to improve survival rates by varying the presence or absence of chemotherapy and hematopoietic stem cell transplantation based on genetic characteristics at the time of diagnosis and minimal residual disease (MRD) values measured by various methods after treatment.

In addition, by clearly defining the patient group that requires hematopoietic stem cell transplantation, it is expected that the role of hematopoietic stem cell transplantation in infantile leukemia, for which there have been various guidelines for hematopoietic stem cell transplantation, can be confirmed. Additionally, due to the characteristics of infants, this study aim to identify long-term sequelae or prognosis related to treatment by prospectively collecting side effect data related to treatment during and after treatment.

Infant leukemia patients are classified into low/intermediate/high risk groups and hematopoietic stem cell transplantation is performed after chemotherapy or chemotherapy as shown in the schema below.

* Low risk group : Induction chemotherapy-Low Risk Consolidation chemotherapy 1\~4 - Maintenance chemotherapy
* Intermediate risk group : Induction chemotherapy-High Risk Consolidation chemotherapy 1\~4 - Maintenance chemotherapy
* High risk group : Induction chemotherapy-High Risk Consolidation chemotherapy 1\~4 - hematopoietic stem cell transplantation

Eligibility Criteria:
Inclusion Criteria:

* The age of diagnosis is less than 1 year old
* The disgnosisi of ALL or ALAL(lymphoid predominant)
* Informed consent of the parents(guardians) before participation in this study

Exclusion Criteria:

* Burkitt leukemia/lymphoma or mature B-cell leukemia
* Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or other bone marrow failure syndrome, hematopoietic stem cell transplantation
* Relapsed infant leukemia
* Participants with contraindication to medication
* Administered systemic steroid therapy within 4 weeks prior to this study
* Participants in other interventional studies other than this protocol
Therapeutic Effects of Immuno-targeted Therapy Combined With or Without RT for HCC

The objective of this retrospective cohort study is to investigate the therapeutic effects of combined immunotherapy and targeted therapy, with or without radiotherapy, in patients with hepatocellular carcinoma.

The main question it aims to answer is:

Does the addition of radiotherapy to immunotherapy and targeted therapy enhance the therapeutic effect more significantly compared to immunotherapy and targeted therapy alone for patients with hepatocellular carcinoma?

A retrospective analysis will be conducted on the clinical data of patients with hepatocellular carcinoma who underwent combined immunotherapy and targeted therapy with radiotherapy, as well as those who received immunotherapy and targeted therapy alone, at Zhongshan Hospital, Fudan University, from January 1, 2017, to December 31, 2023. The pmary objective is to assess the disparities in treatment efficacy and treatment-related adverse events between the two cohorts.

Eligibility Criteria:
Inclusion Criteria:

1. Hepatocellular carcinoma confirmed by histopathological/cytopathological examination, or fulfilling the clinical diagnostic criteria for primary liver cancer according to the Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2024 edition).
2. Patients with hepatocellular carcinoma who received targeted therapy and immunotherapy at Zhongshan Hospital affiliated with Fudan University from January 1, 2017, to December 31, 2023.
3. Tumor staging meeting at least one of the following criteria: 1) CNLC stage IIIa or IIIb hepatocellular carcinoma with concurrent vascular invasion or extrahepatic metastasis; 2) CNLC stage IIb hepatocellular carcinoma presenting as a localized lesion unsuitable for surgical resection or transarterial chemoembolization (TACE); 3) Presence of main portal vein or inferior vena cava tumor thrombus; 4) Disease progression observed after multiple local treatments (such as surgical resection, TACE, radiofrequency ablation, etc.).
4. Availability of complete clinical and follow-up information.
5. Patients have provided informed consent for donation of biological samples, allowing the donated samples and related information to be used for all medical research purposes.

Exclusion Criteria:

1. Contraindications for radiotherapy include hepatocellular carcinoma with diffuse intrahepatic lesions, PS score of 3-4, Child-Pugh C liver function, or the presence of severe underlying medical conditions.
2. Known components of the patient population include cholangiocarcinoma (ICC), mixed hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or fibrolamellar carcinoma.
3. Exclusion criteria encompass a history of malignancies other than hepatocellular carcinoma within the past 5 years, except for limited-stage tumors considered cured, such as cervical carcinoma in situ, basal cell carcinoma, and prostate carcinoma in situ.
4. Any other circumstances that the investigator deems unsuitable for participation in the study are also exclusion criteria.
Efficacy and Safety of Remdesivir and Tociluzumab for the Management of Severe COVID-19: A Randomized Controlled Trial

This randomized clinical trial was designed and intended to evaluate the efficacy of Remdesivir and Tocilizumab as a treatment for severe Acute Respiratory Distress Syndrome (ARDS) caused by Coronavirus disease 2019 (COVID-19). Our aim is to find the best option for the treatment and management of ARDS in COVID-19 patients.


Eligibility Criteria:
Inclusion Criteria:

Severe COVID-19 patients require hospitalization under HDU/ICU. The SARS-CoV-2 infection will be confirmed by RT PCR / CT Chest in every case.

Exclusion Criteria:

* Participants with uncontrolled clinical status who were hospitalized from the before.
* Contraindication / possible drug interaction.
* Participants who have any severe and/or uncontrolled medical conditions like, Severe ischemic heart disease, epilepsy, malignancy, Pulmonary/renal/hepatic disease, AIDS, Pulmonary TB, pregnancy, Corpulmonale, and etc.
Study of the Efficacy of PedyPhar® Ointment on the Diabetic Foot Ulcers

Clinical Trial Phase III-b

Study Sponsor:

European Egyptian Pharmaceutical Industries

Sample Size:

120 patients (60 per arm)

Study Population:

Patients with Diabetic foot ulcer of any stage after proper surgical treatment - if needed. Those patients will be recruited from patients attending the Diabetic foot Center at Faculty of Medicine - Alexandria University and the outpatient clinic at Faculty of Medicine, Cairo University.

Recruitment Period: 9 months

Dose application: thick layer of 2-3 mm applied to the dressing then dressing applied to the ulcer.

Endpoints: Complete healing of the ulcer OR 5 months of application of the ointment whichever comes first

Study Design:

This is an open label randomized non-placebo study in which 120 subjects will be randomly allocated to treatment with PedyPhar ointment or Panthenol ointment for their diabetic foot ulcer. Treatment with the ointment will be preceded by appropriate surgical treatment to remove necrotic tissue as indicated by a surgeon for foot ulcer Wagner stages 3-5. Also, diabetic status will be controlled as part of the study. Ointment in either arm will be applied to the ulcer for a maximum of 5 months or till complete healing whichever happens first.

Patients will visit study center every 2 weeks where assessment of the ulcer will be done and patient will be given the ointment for the dressing enough for 2 weeks.

Blood flow in the affected leg will be assessed besides kidney functions complete blood picture besides kidney functions. Diabetic status will be monitored every months and glycosylated hemoglobin will be done every 3 months

Study Duration: 12 months

Study Agent/Intervention Description: PEDYPHAR® is a new patented local ointment composed of natural (Royal Jelly) and (Dexpanthenol) in an innovated, enriched alkaline ointment base.

Dose application: thick layer of 2-3 mm applied to the dressing then dressing applied to the ulcer.

Eligibility Criteria:
Inclusion Criteria:

* Adult diabetic foot syndrome subjects over 18 years of age of any sex
* All stages of diabetic foot syndrome including Wagner stage 5 - Mid-foot gangrene only after appropriate surgical treatment.
* Patients suffering from type 1 or type 2 diabetes mellitus with diabetic foot syndrome.
* Stable metabolic and pharmacological control at recruitment and during the trial period.
* Adequate perfusion of lower limb as measured by HHD and confirmed by APSV.

Exclusion Criteria:

* Non-diabetic foot ulceration (traumatic, thermal ulceration etc)
* Diabetic foot syndrome graded 5 on Wagner's scale - hind foot gangrene only.
* Any pathological state or disease which can affect the development and outcomes of diabetic foot syndrome such as liver cell failure and renal failure
* Severe limb ischemia (by clinical assessment and HHD) unless re-vascularized.
* Presence of slough or sequestrum unless debrided.
* Hemoglobin less than 8 g/dl unless corrected.
* Those receiving NSAIDs, steroids or anti-mitotic drugs.
* Septicemia patients requiring urgent amputation.
Ketamine Effects on Learning In Eating Disorders

This is a single site, single dose clinical trial of intravenous (IV) ketamine for medically hospitalized adolescents and young adults with anorexia nervosa or atypical anorexia nervosa. Eating disorder symptoms will be measured pre- and post-ketamine infusion. Investigators hypothesize that ketamine will increase cognitive flexibility, making medical hospitalizations less distressing by improving the ability to learn new, positive associations with food.


Eligibility Criteria:
Inclusion Criteria:

1. Age 16-26 years old
2. Meets diagnosis of anorexia nervosa (AN) or atypical anorexia nervosa (atypical AN) per DSM-5 criteria on admission
3. Admitted to the medical hospital for malnutrition
4. No changes to psychiatric medications for month prior to trial enrollment
5. Agree to use a highly effective form of contraception for at least two weeks following ketamine administration
6. Have an outpatient primary care provider, medical provider, or behavioral health provider or psychiatrist who is actively managing or coordinating care

Exclusion Criteria:

1. Lifetime history of any psychotic disorder
2. Moderate or severe substance use disorder
3. Pregnancy as indicated by a positive urine pregnancy test during screening, lactation, or the intention of becoming pregnant within 3 months of entry into this trial
4. Electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) treatment within 30 days prior to enrollment
5. Intellectual or developmental disability
6. High risk for self-harm/suicide
7. Active laxative misuse or abuse
8. Biochemical refeeding syndrome or electrolyte abnormality
9. Cardiac abnormalities identified on admission
10. Taking medications that would be unsafe to administer with ketamine
11. Other medical condition or diagnosis, physical exam finding, laboratory abnormality, or health risk that would increase the risk of adverse events, at the discretion of the investigators