cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Training Programme of Service Doctors and Trainees

Objectives: The aim of this study is to evaluate the quality of training of the Resources Allocation Exercise (RAE) training programme for higher trainees (HT) and service doctors (SD) in the Hospital Authority (HA) using an evidence-based structured and comprehensive evaluation framework to identify areas for quality enhancement.

Design, Setting and Subjects: A longitudinal study will be conducted using the Action Learning and Audit Spiral methodologies to measure whether the target standard of training intended by the RAE training programme is achieved. Each cluster coordinator will be invited to complete a questionnaire on structure and process of training. All eligible HT and SD will be invited to complete a questionnaire on the process of training and their training and education background. All HT and SD will also be included in the evaluation on the outcomes of training programme.

Main Outcome Measures: The primary outcomes are the proportion of clusters that have satisfied each of the structure criteria, HT and SD who have reported the criterion process of training, and HT and SD who have rated the training programmes to be of educational value.

Data Analysis: Descriptive statistics on standard of training will be calculated. Regressions will be used to identify factors that are associated with quality of training.

Hypothesis: The quality of training of the RAE training programme will be determined. Areas of deficiency and possible areas for quality enhancement will be identified. The results of this study will provide empirical evidence on the quality of RAE training programme for HT and SD. It also provides information on the effectiveness of RAE training programmes for improving skills and knowledge of primary care doctors.

The structure, process and outcomes of special training programmes for service doctors and family medicine trainees in public primary care clinics in Hong Kong will be evaluated by two audit cycles from 2011 to 2012.

Data Collection

All records of released training sessions of doctors or trainees of all public primary care clinics in Hong Kong, the training curriculum, the participation rates, and participant rating on effectiveness will be reviewed.

Outcome Measures

1. Participation rate
2. Annual participation frequency per doctor
3. Proportion of doctors rating the training effective
4. Success rate in end of training examination pass rate.

Expected results The information will inform whether the special training programmes for service doctors and trainees are effective in enhancing knowledge, skills and success in professional examination.

Eligibility Criteria:
Inclusion Criteria:

* All HA service doctors who have not had any vocational training and all HA doctors currently enrolled in Hong Kong College of Family Physicians - Family Medicine (HKCFP FM) higher training will be recruited.

Exclusion Criteria:
Gastrointestinal and Health-related Quality of Life Outcomes in Patients With Autoimmune Diseases Treated With Mycophenolate

Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients. This study will 1) determine the proportion of patients with autoimmune diseases who are experiencing any GI complaints under MMF-based immunosuppressive treatment and 2) assess if a switch from MMF to enteric-coated mycophenolate sodium (EC-MPS) results in improved GI and/or health-related quality of life outcomes.


Eligibility Criteria:
Inclusion criteria:

1. Patients with autoimmune diseases;
2. receiving immunosuppressive therapy that includes MMF at time of study enrollment;
3. receiving immunosuppressive regimen that includes MMF at a stable dose for at least 1 month prior to enrollment. Patients can only be enrolled into the study if it is expected that treatment will continue at the same dose until study end (6-8 weeks after enrollment).

Exclusion criteria:

1. If applicable, GI symptoms assumed or known not to be caused by Mycophenolic acid (MPA) therapy (e.g. oral biphosphonates induced, infectious diarrhea);
2. Women of child-bearing potential who are planning to become pregnant or are pregnant and/or lactating or who are unwilling to use effective means of contraception;
3. Presence of psychiatric illness (i.e., schizophrenia, major depression) that, in the opinion of the site investigator, would interfere with study requirements;
4. Current acute medical intervention or hospitalization;
5. Presence of a medical condition not related to a GI event at time of visit, which requires immediate medical intervention.

Other protocol-defined inclusion/exclusion criteria may apply
Combined and Isolated Effects of Sleep Deprivation and Alcohol Intake on Exercise Performance in Humans.

Although the effects of acute alcohol intake and sleep deprivation on exercise performance lacks evidence in the literature, in many situations, they occur simultaneously. Once the alcohol affects physiological processes, the processes that occur during sleep can be impaired, such as: suppression of GH release, action of neurotransmitters and neuromodulators in the CNS, changes in the proportion of sleep stages and may lead to suppression of REM sleep. These changes promote a significant functional impairment such as a reduction in alertness and modification in reaction time, which affects the performance of any activity of daily and professional life. However, the combined effects on the physical performance variables, such as aerobic and neuromuscular performance lack of evidence in the literature.

Ten subjects were randomized in four situations after familiarization and control situation: (1) alcohol intake combined with sleep normal; (2) alcohol intake combined with sleep deprivation; (3) placebo intake combined with sleep normal and (4) placebo intake combined with sleep deprivation.

Eligibility Criteria:
Inclusion Criteria:

- Physical active men

Exclusion Criteria:

* AUDIT questionnaire above 15 points
* Nocturnal Chronotype
* Skeletal muscle injuries in upper and lower limb
* Metabolic and cardiovascular disease
Use of 2-octylcyanoacrylate With Full-thickness Skin Grafts

The purpose of this study is to determine whether the use of 2-octylcyanoacrylate during repair of cutaneous surgery wounds with full-thickness skin grafts improves scar cosmesis compared to wound closure with sutures.

The purpose of this study is to determine whether the use of 2-octylcyanoacrylate during repair of cutaneous surgery wounds with full-thickness skin grafts improves scar cosmesis compared to wound closure with sutures. Our aims are to compare outcomes using a split wound model, where half of the wound is treated with 2-octylcyanoacrylate and the other half is repaired with sutures, per the standard of care. Three-months post-surgery, the scar will be measured via the physician observer scar assessment scale, a validated scar instrument. Our hypothesis is that 2-octylcyanoacrylate will result in cosmetically superior wound outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* Able to give informed consent themselves
* Patient scheduled for cutaneous surgical procedure with predicted closure with full-thickness skin graft
* Willing to return for follow-up visits

Exclusion Criteria:

* Mentally handicapped
* Unable to understand written and oral English
* Incarceration
* Under 18 years of age
* Pregnant Women
* Patients on systemic steroid therapies
* Patients with Marfans
* Patients with allergies to 2-octylcyanoacrylate
Home-based Action Observation Treatment With Virtual-reality for Arm Rehabilitation in People With Multiple Sclerosis

Action Observation Treatment (AOT) is a rehabilitative strategy which has been proposed as a promising approach to improve motor performance in neurological conditions, including multiple sclerosis (MS).

In this clinical trial, the investigators aim to explore the role of a home-based AOT with virtual reality (VR) in improving upper limb motor function in people with MS (PwMS). The objectives are:

* To compare the effects of home-based VR-AOT versus VR-landscape observation (LO) on upper limb motor performance;
* To measure brain network functional changes (functional plasticity) and structural variations of gray matter (GM) and white matter (WM) (structural plasticity) using advanced magnetic resonance imaging (MRI) techniques following VR-AOT and VR-LO;
* To study the correlations between MRI changes and clinical improvements and the predictors of VR-AOT efficacy.

All participants will undergo treatment sessions for 3 weeks (5 consecutive days/week, total=15 sessions lasting 30 minutes each). Those in the VR-AOT group will observe, imagine and execute two upper limb motor tasks in each session. Those in the VR-LO group will perform the same tasks, but they will observe inanimate landscapes beforehand instead.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years;
* Diagnosis of MS according to 2017 revised McDonald criteria;
* Ability to understand the purpose and risks of the study and provide signed informed consent;
* Ability to remotely perform VR-AOT;
* Right pre-morbid handedness (EHI\>50);
* Muscle strength deficit involving the right upper limb (≥1 point decrease of MRC scale);
* Presence of activity limitation of the right hand (need of adaptations, supervision or help by another person for the execution of daily living activities according to items 1-6 of the FIM);
* EDSS score 2.0-7.0 (inclusive);
* Cerebellar functional system score of the EDSS ≤1;
* Baseline 9HPT score \>21 seconds and \<180 seconds.

Exclusion Criteria:

* MRI contraindications;
* Significant visual deficits not allowing to observe VR stimuli;
* Moderate to severe pain disturbances (VAS≥4);
* Concomitant neuro-psychiatric or systemic diseases (other than MS);
* Clinical relapses or steroid treatment in the past 3 months;
* Modification of symptomatic treatment or botulin toxin injection in the upper limb in the past 3 months;
* Stable disease-modifying treatment for MS for ≤6 months;
* Rehabilitation treatment in the past 3 months.
A Safety, Tolerability, PK and Preliminary Activity Study of GB263T in Advanced NSCLC and Other Solid Tumor

This is a Phase 1/2 study of GB263T in participants with advanced NSCLC and other solid tumor. The study will consist of a dose-escalation and expansion stage to determine RP2D (Phase 1), and an extension stage (Phase 2) where participants will be enrolled into indication-specific cohorts.


Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years of age.
2. Subjects with histologically or cytologically confirmed metastatic or unresectable advanced NSCLC or other solid tumors who have progressed on prior standard therapy, have been intolerant to prior standard therapy, or have refused all other currently available therapeutic options.
3. Subjects must have evaluable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
4. ECOG PS 0-1.
5. An expected survival time is ≥3 months.
6. Adequate organ function.
7. Subjects in Phase II must agree to provide pre-treatment tumor tissue samples.

Exclusion Criteria:

1. Subjects who have had prior chemotherapy, targeted cancer therapy, immunotherapy, or any investigational anti-cancer treatment within 2 weeks or five half-lives of the treatment (whichever is longer), prior to the first administration of the study drug.
2. Toxicity (excluding alopecia, peripheral neuropathy, and hypothyroidism) that did not return to class 0 or class 1 of NCI CTCAE V5.0 from prior antitumor therapy prior to the first administration of the study drug.
3. Prior radical radiation therapy completed within 4 weeks prior to the first administration of the study drug.
4. Subjects with untreated symptomatic brain metastases.
5. History of interstitial lung disease (ILD).
6. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
7. Received live virus vaccination within 30 days of first dose of study treatment.
Efficacy of Bilateral Modified Catheter Antegrade Cerebral Perfusion in Acute Type A Aortic Dissection Surgery

This retrospective cohort study aims to evaluate the efficacy of a Bilateral Modified Catheter Antegrade Cerebral Perfusion (Modified bACP) technique in acute Type A aortic dissection surgery. Medical records from January 1, 2021, through October 31, 2024, at China Medical University Hospital will be reviewed. The primary outcomes include in-hospital mortality and stroke rate, while secondary outcomes include ICU/hospital stay, mechanical ventilation duration, and other postoperative complications (e.g., acute kidney injury, sepsis, myocardial infarction).

Background and Rationale Acute Type A aortic dissection (ATAAD) is a life-threatening condition requiring urgent surgical repair. Prolonged circulatory arrest increases the risk of neurological complications. Bilateral antegrade cerebral perfusion (bACP) has shown potential to reduce ischemic injury. However, conventional bACP requires additional surgical access. This study examines a Modified bACP approach that may reduce surgical trauma while maintaining adequate cerebral perfusion.

Objectives This retrospective cohort study evaluates whether Modified bACP improves postoperative outcomes compared to conventional perfusion strategies in ATAAD surgery at China Medical University Hospital (2021/1/1-2024/10/31).

Methods We will collect and analyze medical records of adult patients who underwent ATAAD repair, comparing those who received Modified bACP to those managed with conventional perfusion.

Outcome Measures

Primary Outcomes:

In-hospital mortality 30-day mortality

Secondary Outcomes:

Hospital length of stay (day) ICU length of stay (day) Mechanical ventilation duration (hours) Need for tracheostomy Stroke Postoperative neurological deficit Paraplegia Coma Atrial fibrillation (Af) Myocardial infarction Acute kidney injury (AKI) Dialysis requirement Reoperation for bleeding Sepsis Significance This study aims to provide comprehensive data on the safety and efficacy of Modified bACP in ATAAD surgery, potentially improving neurological protection and reducing other major complications and resource utilization. The findings may guide clinical practice and inform future protocol developments.

Eligibility Criteria:
Inclusion Criteria:

* Adults (≥ 18 years old) who underwent acute Type A aortic dissection repair at China Medical University Hospital between January 1, 2021, and October 31, 2024.

Exclusion Criteria:

* Preexisting severe neurological impairment (e.g., stroke or other major neurological deficits before surgery).
* Age \< 18 years.
* Pregnant patients.
* Insufficient or missing medical records preventing data analysis.
Influence of Administration Route of Testosterone on Male Fertility

Exogenously administered testosterone will override the normal negative feedback of endogenous testosterone on the hypothalamus and pituitary. Constantly, relatively high and constant testosterone levels will cause a drop in FSH and LH production by the pituitary. Since FSH and LH are signalling hormones to the testes, endogenous testosterone production and spermatogenesis will be down-regulated. It is expected that intranasal dosing in the morning will mimic the normal physiological pattern of testosterone production thereby avoiding negative side-effects on spermatogenesis. Trans-dermal gels give testosterone levels more or less constant over the day and will very likely have inhibitory effects on spermatogenesis.

The main objective of this study is to show that twice daily intranasal dosing does not have, or has a smaller inhibitory effect on spermatogenesis in comparison to transdermal testosterone gels.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 50 years but not older than 80 years of age;
* Serum testosterone level \<13.8 nmol/l;
* Sperm concentration \> 40 Million/ml;
* Willing to give written informed consent.

Exclusion Criteria:

* Testicular diseases or having had any surgical procedures applied to the testes;
* History or currently existing serious disease of any type, in particular liver, kidney or heart disease, any form of diabetes mellitus, cancer or psychiatric illness;
* Current androgen, anabolic steroid or sex hormone treatment or any treatment with such compounds in the previous 6 months;
* Blood donation within the 12-week period before the initial study dose.
* History of, or current nasal disorders (e.g. seasonal or perennial allergic rhinitis, atrophic rhinitis, polyposis, abuse of nasal decongestants, clinically relevant nasal septum deviation, recurrent epistaxis) or sleep apnea;
* Elevated serum PSA levels (\> 4 ng/ml for subjects \>= 50 years of age);
Study to Assess the Efficacy and Safety of Sitagliptin Added to the Regimen of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (0431-189)

After 24 weeks of treatment, to assess the A1C-lowering efficacy of sitagliptin 100 mg once daily added to the regimen of patients with inadequate glycemic control on metformin monotherapy


Eligibility Criteria:
Inclusion Criteria:

* Patient Has Type 2 Diabetes Mellitus
* Patient Is 30-78 Years Of Age On The Day Of Signing Informed Consent
* Patient Is Currently On Metformin Therapy (1500 Mg/Day)
* Patient Is A Male Or A Female Who Is Unlikely To Conceive, As Indicated By At Least One Yes Answer To The Following Questions: A) Patient Is A Male. B) Patient Is A Surgically Sterilized Female. C) Patient Is A Postmenopausal Female 45 Years Of Age With \>2 Years Since Last Menses. D) Patient Is A Non-Sterilized Premenopausal Female And Agrees To Use An Adequate Method Of Contraception To Prevent Pregnancy Throughout The Study Starting With Visit 1 And For 14 Days After The Last Dose Of Study Medication
* Patient Understands The Study Procedures, The Alternative Treatments Available, The Risks Involved In The Study And Voluntarily Agrees To Participate By Giving Written Informed Consent
* Patient Has An A1c of 6.5 % - 11.0%

Exclusion Criteria:

* Patient Has A History Of Type 1 Diabetes Mellitus Or History Of Ketoacidosis
Safety and Efficacy of Empagliflozin for Patients With Diabetes Mellitus and Planned Percutaneous Coronary Interventions

Aim: To study the effectiveness and safety of empagliflozin as a preoperative preparation tool, as well as to improve the long-term prognosis of planned percutaneous coronary interventions in patients with type 2 diabetes

Patients with type 2 diabetes will be randomized into 2 groups using the envelope method. One group will receive empagliflozin 10 mg 1 month before planned percutaneous coronary interventions and for 12 months thereafter in addition to previously taken hypoglycemic therapy. Patients of the second group will continue to take previously prescribed hypoglycemic therapy.

Thus, the safety and effectiveness of empagliflozin for preoperative preparation of patients with type 2 diabetes before planned percutaneous coronary interventions will be evaluated, as well as the impact on the immediate and long-term outcomes of percutaneous coronary interventions in comparison with patients on standard hypoglycemic therapy

Eligibility Criteria:
Inclusion Criteria:

* signed inform concent
* stable coronary artery disease
* planned percutaneous coronary intervention
* diabetes mellitus

Exclusion Criteria:

* previously performed coronary revascularization
* glomerular filtration rate less than 45 ml/min
* intolerance to empagliflozin
* serum potassium more than 5/5 mmol/l
* heart failure (NYHA III-IV)
* congenital heart disease
* acute coronary syndrome less than 3 months before enrollment
Effects of Additional Axial Load on Cervical Motor Control

he objective of this study is to examine the influence of additional axial load abd body position on cervical motor control in young healthy adults.

Motor control of the cervical spine is impotent for responsible for maintaining balance during daily living activities and to withstand external loads. Stabilization-aspects of the cervical spine is very complex, passive (ligaments, joint capsule and the skin and active (muscles), and neurological subsystems are involved. Mostly proprioceptive testing and exercises like head and neck position sense testing and re-training have been an integral part of rehabilitation. Another method to evaluate spinal motor control is the assessment of spinal stiffness. The main objective of this study is to explore the effects of additional axial loading on motion control in healthy individuals. Does the motor control of the cervical spine in healthy subjects change with additional axial load or body position? A better understanding of spinal stiffness and neck position sense leads to novel insights into spinal cervical stabilization mechanisms.

Eligibility Criteria:
Inclusion Criteria:

Healthy participant's Signed informed consent after being informed

Exclusion Criteria:

Acute pain Chronic neck pain Undergone Neck surgery Neck Disability Index Score \> 15
A Research Trial Looking at the Comparability of 2 Different Concentrations of Semaglutide for the 0.5 Milligram (mg) Dose

In this study, a known investigational medicine called 'semaglutide' will be tested in 2 drug concentrations of 0.68 milligram per milliliter (mg/mL) and 1.34 mg/mL. Both drug concentrations are tested for the treatment of type 2 diabetes. The U.S. Food and Drug Administration (FDA), has approved semaglutide in prefilled pen-injector form. Currently, the drug concentration of 1.34 mg/ml can be prescribed in some countries including U.S. The objective of the study is to compare the amount of investigational drug taken up in the body for the 2 drug concentrations. Participants will be divided by chance into 2 groups. Group A will receive a single dose of 0.5 mg semaglutide of the drug concentration 1.34 mg/mL in the first study period; and will receive a single dose of 0.5 mg semaglutide of the drug concentration 0.68 mg/mL in the second study period. Participants assigned to group B will receive the two drug concentrations in the reverse order. Participants will get 1 subcutaneous injection on Day 1 of each of the two study periods. The two injections are separated by 7-11 weeks. The study will last up to approximately 87 to 141 days for each participant. This includes a screening period (up to 4 weeks), study period 1 (5 weeks), washout period (2-6 weeks), and study period 2 (5 weeks). At some periods during the study, participant should not get vaccinations. Participant should agree on timing of vaccination with study doctor. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Aged 18-55 years (both inclusive) at the time of signing informed consent
* Body mass index (BMI) between 20.0 and 29.9 kilograms per meter square (kg/m\^2) (both inclusive)

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method
* Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
* Use of prescription medicinal products or non-prescription drugs, except routine vitamins, topical medications, highly effective contraceptives and occasional use of paracetamol, ibuprofen and acetylsalicylic acid, within 14 days prior to the day of screening
* Abuse or intake of alcohol, defined as any of the below:

  1. Known or suspected alcohol abuse within 1 year before screening (defined as regular intake of more than an average intake of 24 grams (g) alcohol daily for men and 12 g alcohol daily for women - 12 g of alcohol equals about 300 milliliters (mL) of beer or lager, 100 mL of wine, or 25 mL spirits)
  2. Positive alcohol test at screening
* Abuse or intake of drugs, defined as any of the below:

  1. Known or suspected drug or chemical substance abuse within 1 year before screening
  2. Positive drug of abuse test at screening