cyrilzakka/clinical-trials huggingface dataset:
Simulation Based Learning and Academic Performance in Medical School

The investigators will use a multi-methods approach, including both qualitative and quantitative methods. In the quantitative methodology, the investigators will use a before and after approach to compare medical student grades/scores before and after the integration of Simulation based learning (SBL) in the curriculum. The hypothesis is that SBL will generally increase knowledge and skills and hence improve the scores from the theory (MCQ) and clinical (OSCE) examinations conducted outside simulated settings in the clinical departments.

Simulation faculty development will be measured by retention and engagement in simulation sessions. The investigators will use survival analysis methods and plot Kaplan Meier curves to calculate probability of retention and determine the factors that are associated with retention as derived from participant in-depth interviews and departmental meetings. A faculty member will be considered disengaged if they do not participate in simulation session for at least 6 months post training, despite reminders and opportunities for participation. Reasons for potential disengagement will be explored qualitatively.

In the qualitative approach, the investigators will conduct in-depth key informant interviews (45 minutes to 1 hour) with administrators at the institution, namely Academic Registrar, Deans of Medical School, heads of Departments and Simulation facilitators (the post-graduate student trainers). The investigators will conduct focus group discussions (1 hour) with postgraduate simulation facilitators, the medical and nursing students before, during and after their enrollment in SBL. The interviews and focus group discussions will be audio-recorded and transcribed.

Eligibility Criteria:
Inclusion Criteria:

* Medical (Medicine and Nursing) students
* Enrolled in the Faculty of medicine at Mbarara University of Science and Technology
* Currently attending clinical years

Exclusion Criteria:

* Non clinical student years in the Faculty of Medicine
* not enrolled in Medicine or Nursing programs at Mbarara University of Science and Technology
Safety and Efficacy of Paclitaxel Coated PTCA Balloon Catheter With a Shellac Plus Vitamin E Excipient (GENOSS® DCB) in Patients With Coronary In-stent Restenosis (ISR): A Prospective, Multi-center, Observational Study

The SFRGENISTA study aims to evaluate the long-term efficacy and safety of a paclitaxel-coated balloon catheter containing shellac and vitamin E excipients (Genoss® DCB) in patients with coronary in-stent restenosis (ISR).

Drug-coated balloon (DCB) treatment is a therapeutic strategy to overcome in-stent restenosis (ISR) that occurs after drug-eluting stent (DES) implantation. The 2018 European guidelines on myocardial revascularization recommend DCB treatment in patients with bare-metal stent (BMS) or DES ISR lesions. The Sequent Please World Wide Registry has shown that DCB therapy is safe and exhibits a low target lesion revascularization (TLR) rate in a large population.

The Genoss® DCB is coated with 3µg/mm² of paclitaxel along with shellac, a hydrophilic excipient for rapid release and diffusion into the tissue. Additionally, it incorporates vitamin E, an antioxidant known to directly prevent the accumulation of smooth muscle cells associated with neointimal hyperplasia that arises from the vessel wall being damaged by the balloon catheter. The catheter was designed to enhance trackability and pushability, minimize vascular damage with the application of a hydrophilic coating to the distal part, and use a soft yet durable end-tip for easier access to the target lesion. In a clinical trial comparing Genoss® DCB to the Sequent® Please (B-BRAUN) DCB, the in-segment late lumen loss at six months after DCB was comparable, and the rates of adverse clinical events were similar.

Given this background, this study intends to investigate the long-term efficacy and safety of the Genoss® DCB in patients with coronary ISR.

Eligibility Criteria:
Inclusion Criteria:

* Patients with coronary in-stent restenosis (ISR) who underwent percutaneous coronary intervention using the Genoss® DCB.
* Participants who have agreed to the clinical trial protocol and the clinical follow-up study plan, voluntarily decided to participate in this clinical research, and have provided written consent on the research participant agreement form.

Exclusion Criteria:

* Women of childbearing age who plan to become pregnant during the study duration.
* Patients scheduled for a surgery within 12 months of enrollment that requires discontinuation of antiplatelet agents.
* Patients for whom the expected remaining life span is less than one year.
* Patients who presented with cardiogenic shock at the time of their visit and, based on medical assessment, are predicted to have a low likelihood of survival.
* Patients currently involved in a randomized medical device study.
* Patients deemed by the researcher to be unsuitable for this study or whose participation might increase associated risks.
Study on Chronic Hepatitis C Treatment With Interferon Alpha, Ribavirin and Amantadine in Naive Patients

\* Adding Amantadine to standard anti-viral treatment can improve sustained response rates in patients with chronic hepatitis C

The CIRA-study is a double blind, placebo controlled, randomised, multicentre study in previously untreated patients suffering from chronic hepatitis C comparing double therapy, consisting of (PEG-)interferon alpha 2b ((PEG)Intron-A®) and ribavirin (Rebetol®), with triple therapy, consisting of (PEG-)interferon alpha 2b, ribavirin and amantadine, for 52 weeks. Follow-up is completed at week 104. 150 Subjects per treatment group will be included. Patients will be stratified before randomisation according to genotype (1 versus non-1). Viral load will not be a discriminating factor.

The aim is to investigate the efficacy of the adjunct amantadine to the currently used combination therapy with interferon alpha and ribavirin.

Eligibility Criteria:
Inclusion Criteria:

* Anti-HCV positivity \>6 months
* ALT and/or AST elevation on at least once in the previous 6 months
* Positive HCV-RNA
* Liver biopsy within one year before the start of therapy in non- cirrhosis. In the case of known cirrhosis, liver biopsy is not necessary
* Intention to be treated and participate treatment
* Obtained written informed consent

Exclusion Criteria:

* Age \< 18 years
* Pregnancy or intention to get pregnant within the 12 months period of treatment and up to 6 months after discontinuation of therapy, no adequate contraception, lactation
* Men not practicing or willing to practice acceptable methods of contraception during the treatment period and up to 6 months after discontinuation of therapy
* Life expectancy \< 1 year
* Child Pugh B or C (Appendix III)
* Creatinine \> 150 μmol/L or \> 1.70 mg/dl
* Haemoglobulin \< 6.5 mmol/l or \< 10.5 g/dl
* White blood cell count \< 2,5 x 109/L, neutrophil \< 1,5 x 109/L
* Platelet count \< 70 x 109/L
* HIV positivity
* Chemotherapy, systematical antiviral treatment during the 6 months prior to study entry
* Other serious disease (e.g. malignancy, uncontrolled myocardial disease or severe arrhythmias)
* Active uncontrolled psychiatric disorders and suicidal leanings
* Patients with a history of uncontrolled seizure or other significant CNS dysfunction
* Any condition which in the opinion of the (co-)investigator might interfere with the evaluation of the study objectives
Study to Assess the Efficacy and Safety of Levetiracetam for the Treatment of Social Anxiety Disorder (Generalized Type)

Preclinical and clinical findings indicate that LEV has some anxiolytic potential. There is reason to believe that compounds with anxiolytic activity may have broad clinical utility across the anxiety spectrum. This trial was intended to explore LEV's utility in adults with social anxiety disorder.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients between 18 and 70 years old inclusive;
* symptoms of social anxiety disorders (generalized type) present for at least 1 year prior to Selection Visit;
* had a score of \>=60 on the LSAS at the Selection Visit and at the Randomization Visit. Additionally, the clinician's gloal impression of change score must have been \>= 2 at the Randomization Visit;
* had a telephone where they could be directly contacted.

Exclusion Criteria:

* History of autism or Asperger's Disease;
* had another primary axis I disorder or fulfilled diagnostic and statistical manual of mental disorders-4th edition (DSM-IV) criteria in the 6 months prior to Screening;
* major depression as measured by a Hamilton Depression Rating Scale (HAM-D-17 items) total score of \> 17 and/or a suicide subscale score on the HAM-D-17 items of \> 2 at the Selection or Randomization Visit;
* history of electroconvulsive therapy within the prior 3 months;
* history of psychotherapy which was not stable and ongoing for at least 6 months prior to Visit 1;
* clinical history of significantly impaired renal function with an estimated creatinine clearance below 80 mL/min;
* clinically significant medical condition;
* history of any clinically significant allergic condition or allergy to LEV or pyrrolidone derivatives;
* neutrophil count of less than 1800/µL.
Nonalcoholic Fatty Liver Disease is Associated With Increased Atrial Fibrillation Risk in an Elderly Chinese Population

Atrial fibrillation and nonalcoholic fatty liver disease are two pathological conditions that are highly prevalent worldwide and share multiple CVD risk factors. There is rare research performed among elderly adults. The investigators are conducting a cross-sectional analysis of elderly adults (≥65 years) to investigate the association between atrial fibrillation and nonalcoholic fatty liver disease in an elderly Chinese population.

Because of the aging population and improvements in cardiovascular treatments, its prevalence is expected to increase substantially over the next few decades. AF has been reported to be associated with high rates of hospitalization and death. Along with older age, there are many independent risk factors for AF like obesity, hypertension, diabetes, ischemic heart disease, heart failure and valvular heart disease.

Non-alcoholic fatty liver disease is one of the most prevalent liver diseases in the world whose prevalence ranges from 6% to 35%, with a median of 20% in the general population. In recent years, an increasing body of evidence have indicated that NAFLD is linked to cardiovascular disease, myocardial abnormalities, left ventricular diastolic dysfunction, heart failure, aortic valve sclerosis and so on.

NAFLD has also been observed to be significantly associated with AF in patients with type 2 diabetes. Furthermore, a cohort study showed that NAFLD was associated with an increased risk of prevalent AF in a middle-aged population. However, whether the association between NAFLD and AF also holds true in the elderly population remains uncertain. Therefore, the investigators conducted this cross-sectional study to explore the association between NAFLD and AF in an elderly Chinese population.

Eligibility Criteria:
Inclusion Criteria:

* those who undergone an annual physical examination at Zhenhai Lianhua Hospital, Ningbo, China in 2014
* elderly adults (≥65 years old)

Exclusion Criteria:

* unknown alcohol intake or excessive alcohol intake
* unknown BMI or BMI≤18.0kg/m2
* incomplete basic physical data
* missing liver ultrasonic diagnosis
* unknown causes of chronic liver disease
Role of Rapid On-site Evaluation for Mutational Analysis of EBUS-TBNA Specimens

The purpose of the study is to determine if rapid on-site evaluation of EBUS-TBNA samples can increase the percentage of patients with advanced non-squamous non-small cell lung cancer in whom both pathologic subtyping and mutational analysis are obtained.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Suspected hilar or mediastinal lymph node metastasis from lung cancer

Exclusion Criteria:

* Pregnancy
* Uncontrolled coagulopathy
* Refusal to sign informed consent
An 'Off-the-shelf' Assistive Listening Device: Normal-hearing Children.

The cochlea, the sensory organ of hearing, is a structure of the temporal bone on the skull. In everyday life sounds are heard via air conduction. This means that vibrations in the air are conducted through our ear canals, via the eardrum and the middle-ear bones, to the cochlea. However, vibrations can be conducted to the cochlea via the bones of the head. Bone-conduction headsets have become popular for recreational use (for example cyclists and runners wear them to listen to music while exercising). When in a noisy environment, if a speech signal is delivered to a microphone connected via Bluetooth to the bone conduction headset, the person wearing the headset receives the speech signal as if the talker were closer to them. The ratio between the speech level and the noise level (SNR, signal-to-noise ratio) is increased, so that it is easier to understand the spoken message. A previous study carried out by the investigators has shown that this may help children with hearing loss due to otitis media with effusion ('glue ear'). The aim of the current study is to explore the potential of the headset to help children with auditory processing disorder (APD). Typically, children with APD have normal audiograms, but, in spite of this, they struggle to understand speech in a background noise. The headset can deliver the speech message to them. Currently, FM systems are used for children with APD in the classroom. These systems are effective, but their cost is high and provision may be limited. The feasibility of the use of the headset in a group of children with normal audiometric thresholds will be assessed. The study hypothesis is that using a bone-conduction headband improves speech recognition in noise and decreases listening effort even when air-conduction hearing thresholds are normal. Measures of speech recognition and listening effort will be done in quiet and in noise with and without the bone-conduction headset in order to measure the effect of using the headset on speech recognition when hearing thresholds are normal.


Eligibility Criteria:
Inclusion Criteria:

1. Children aged 6 to 11 years old.
2. No developmental concerns
3. No concerns about hearing loss.
4. No concerns about language development.
5. English dominant language.

Exclusion Criteria:

1. History, risk, or parent/carer/teacher concern of hearing loss.
2. Developmental concerns
3. Suspected language disability.
4. Non-English dominant language.
Study of the Effect of Compassion-Based Education Program Applied to Mothers of Children Diagnosed With Cerebral Palsy

Purpose of the study; The aim of this study is to examine the effect of a compassion-based education program applied to mothers of children with cerebral palsy on compassion fatigue, depression, and psychological resilience.

The Hypotheses of the Study

Main Hypothesis: "Compassion-Based Education Program Adapted for Adults" in increasing the compassion levels and psychological resilience of mothers of patients with CP; It is effective in reducing the level of depression.

As sub-hypotheses:

H1: The scores of the mothers who care for their children with Cerebral Palsy in the experimental group at the end of the application (post-test) and after the application (follow-up test) of the Adult Compassion Scale are significantly higher than the scores they obtained before the application (pre-test).

H2: The scores of the mothers who care for their children with Cerebral Palsy in the experimental group at the end of the application (post-test) and after the application (follow-up test) of the Burns Depression Scale-Turkish Form are significantly lower than the scores they obtained before the application (pre-test).

H3: The scores of the mothers who care for their children with Cerebral Palsy in the experimental group at the end of the application (post-test) and after the application (follow-up test) of the Adult Resilience Scale are significantly higher than the scores they obtained before the application (pre-test).

Eligibility Criteria:
Inclusion Criteria:

* Being the mother of a child with Cerebral Palsy

Exclusion Criteria:

* Mothers who have children with Cerebral Palsy do not want to participate in the study and want to leave the study.
Clinical Observation of Drug Retention Enema in Preventing Acute Radiation-induced Rectal Injury

The main objective of this study was to evaluate the efficacy and safety of drug retention enema for the prevention of acute radiation rectal injury in the real world.

The study was a prospective, multicenter, real-world study with eligible patient data as of May 1, 2024. The prospective study was a continuous, multicenter study.

Eligibility Criteria:
Inclusion Criteria:

* There are clear indications for radiotherapy (pelvic radiotherapy or rectal radiotherapy) according to relevant guidelines;
* ECOG score 0-1;
* normal mind, clear consciousness;
* High compliance;
* Able to cooperate with the interviewer

Exclusion Criteria:

* Poor compliance, unwilling to participate or unable to cooperate with the interviewer;
* Patients with other intestinal diseases (such as Crohn's disease, rectal ulcer, anal fissure, anal fistula, hemorrhoids, etc.) and perianal diseases;
* serious heart, brain, liver, kidney disease;
* Long-term immune dysfunction;
* Pregnant or lactating women;
* Patients who terminate treatment for various reasons.
Taping and PMR Effects in Primary Dysmenorrhea

The study is randomized controlled trial,The study conducted in two groups. Group A has given the kinesiology taping on the lower abdomen and back for 1-3 days with progressive muscle relaxation technique for 10-20 minutes and a baseline treatment hot pack at a time twice a day from the start of menstruation and Group B has receive the kinesiology taping on the lower abdomen and baseline treatment hot pack without progressive muscle relaxation technique for 1-3 days. The total treatment duration will be 6 weeks. The rationale of this study is to provide empirical evidence regarding the efficacy and safety of kinesiology taping and progressive muscle relaxation. By investigating the potential benefits of this intervention, healthcare professionals can make informed decisions about incorporating K-taping and PMR in primary dysmenorhea. Focusing on the impact of kinesiology taping and progressive muscle relaxation on pain,anxiety, and body awareness aligns with a patient-centered approach to care. The goal is not only to reduce symptoms but also to enhance overall well-being and functional capacity

The literature gap of the study is that upto our knowledge, there is little or no evidence found in previous researches on the combined effects of kinesiology taping in combination with progressive muscle relaxation technique in primary dysmenorrhea.

Eligibility Criteria:
Inclusion Criteria:

* • Aged between 18-25 years

  * Unmarried female
  * Taking ≥4 points from Visual Analog Scale during menstrual cycle
  * Had moderate menstrual pain as measured by WaLLID score

Exclusion Criteria:

* • Complaints of low back pain due to any other pathology, any skin infection, sensitive skin or allergic to Kinesio Tape.

  * PCOD, Uterine/ ovarian tumor, Acute/ chronic pelvic pathology like PID, endometriosis, spinal pathology and deformity
  * Endometrial polyp, having a pelvic infection, using an intrauterine device, having venous congestion in the internal genital organs.
  * Who take analgesic
Evaluate the Efficacy of Using Modified Qing-Ying Decoction in Atopic Dermatitis Children

The study aims to evaluate the clinical efficacy and safety of the modified Qing-Ying Decoction (mQYD) for the treatment of subacute and chronic atopic dermatitis (AD) in children when compared to the placebo control through examining the clinical symptoms, quality of life, gut microbiome, and Chinese medicine body constitution.

This is a parallel, randomized, placebo-controlled, double-blind clinical trial. Eligible subjects will be randomly allocated to receive oral mQYD granules or it's placebo granules. Subjects will have 12-week of treatment, and then a 4-week follow-up.

The subjects will come for a screening visit at week 0 (baseline), then at week 6, week 12, and week 16 for Chinese medicine practitioner (CMP) investigators assessments. Eczema Area and Severity Index (EASI), Children's Dermatology Life Quality Index (CDLQI), Patient-Oriented Eczema Measure (POEM), and Chinese Medicine body constitution types will be assessed and filled up at different timepoints. They will receive oral herbal mQYD or placebo granules for 12 weeks and then be followed up 4 weeks after the treatment. Registered CMPs will provide consultation under Chinese medicine theory. Study medication compliance and adverse events will also be assessed at each visit. Besides, they need to record the food taken in a diary before the day for taking faecal specimen for gut microbiome analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Age of 4 to 17 (Chinese only);
2. With EASI ≥ 10;
3. Subacute and chronic atopic dermatitis presenting with dry, scaly, erythematous papules and plaques; and
4. Provide written informed consent form (signed by one of their parents)

Exclusion Criteria:

1. History of allergy to Chinese medicines;
2. AD with Yang deficiency in syndrome differentiation, such as pale looking, always feeling cold, fatigue, chronic diarrhea with loose stool, urinary disorders such as urinary difficulty, excessive urination or incontinence
3. Known overt bacterial infections in the skin;
4. Known pregnancy;
5. Known severe medical conditions, such as cardiovascular, liver or renal dysfunction or Diabetes Mellitus;
6. Having used oral corticosteroids, oral antibiotics, other immunosuppressive or any preparation of oral herbal medicines for the treatment of AD in the past month;
7. Having been diagnosed with scabies, allergic contact dermatitis, seborrheic dermatitis or psoriasis; and
8. Has taken anti-coagulant or anti-platelet drugs in the past month.
9. Has taken any probiotics, prebiotics in the last month
10. Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency
Study of CS-3150 in Combination With ARB or ACE Inhibitor in Hypertensive Patients With Moderate Renal Impairment

To examine antihypertensive effect and safety of administration of CS-3150 in combination with ARB or ACE inhibitor in hypertensive patients with moderate renal impairment.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects aged 20 or order to 80 or younger years at informed consent
* Subjects with hypertension (Sitting SBP ≥ 140 mmHg, \<180 mmHg and Sitting DBP ≥ 80 mmHg, \<110 mmHg
* Treatment with an ARB or ACE inhibitor
* eGFR ≥ 30 mL/min/1.73 m2 and \< 60 mL/min/1.73 m2

Exclusion Criteria:

* Secondary hypertension or malignant hypertension
* Diabetes mellitus with albuminuria
* Subjects under Insulin treatment
* Subjects under or pre-planned for hemodialysis
* Serum potassium level \< 3.5 or ≥ 4.8 mEq/L