cyrilzakka/clinical-trials huggingface dataset:
Exercise-induced Changes in DNA-methylation

The purpose of the study was to investigate whether regular moderate- or high-intensity interval training can change the DNA methylation in a long-lasting state, and whether these changes affect the gene expression. In addition, the investigators will determine whether the intensity of the training could be an affecting factor of the possible DNA-methylation change as well. The null hypothesis was that no such exercise-induced changes occur.


Eligibility Criteria:
Inclusion Criteria:

* Male
* 70-75 years old
* Signed written informed consent

Exclusion Criteria:

* Incompatible with exercise
* Known cardiac disease
* Active cancer
* Significant pulmonary disease
* Uncontrolled hypertension
* Use of blood thinning medicine (except Albyl-E)
* Drug abuse
* Alcohol abuse
* Finishing less than 80% of the exercise sessions (this complies to the training groups)
Parenting Program for Parents of Children With Emotional and Behavioral Issues: A Randomized Control Trial

The main objectives of the study are:

1. To find out the effectiveness of Helpful Parenting Program (HPP) for psychological functioning of children's parent having behavioral and emotional issues.
2. To decrease psychological distress among children's parent having behavioral and emotional issues.

In this Helpful Parenting Program, N=200 participants would be enrolled for eligibility assessment from different schools in Faisalabad. 70 participants after the eligibility assessment and screening would be allocated to experimental and waitlist treatment condition. Participants would be allocated through random assignment using block randomization. In experimental group, the parents of children with emotional \& behavioral issues will be included and 8 to 10 sessions of helpful parenting program would be provided to the parents. Each of the group will be comprised of n=35.

Eligibility Criteria:

Only parents with dysfunctional parenting practices, having children with emotional and behavioral issues would be a part of the study. Second, Only parents would be included in the study who score above 18 on SDQ-4. Only parents having children aged 5 to 12 years would be included in the study. Parents with major psychological disorders would be excluded from the study. The parent served as single parent would be excluded from the study.The participants would be taken from any socioeconomic status.

Interventions:

8-10 sessions with 60 minutes duration once in a week will be conducted with the parents in group and one-on-one setting. Helpful parenting program would be based on social learning theory, behavior modification and couple counseling. The program will be used as an intervention strategy with parents to built insight about their child's emotional \& behavioral issues. Different strategies to teach parenting skills will also be used as an intervention. Further more, this program will target parents' psychological distress and couples' problematic conflicts regarding parenting.

Expected Outcomes:

This study will help to provide valuable information to mental health professionals to understand and develop guidelines for parents of children with emotional \& behavioral issues. Further, this program would decrease psychological distress \& couple's problematic conflicts among parents and improve the psychological functioning of parents. Moreover, this program will improve parental competence and make them independent problem solvers.

Eligibility Criteria:
Inclusion Criteria:

* Only parents with dysfunctional parenting practices, having children with emotional and behavioral issues would be a part of the study. Second, Only parents would be included in the study who score above 18 on SDQ-4. Only parents having children aged 5 to 12 years would be included in the study. The participants would be taken from any socioeconomic status.

Exclusion Criteria:

* Parents with major psychological disorders would be excluded from the study. The parent served as single parent would be excluded from the study.
A Study to Evaluate the Efficacy, Drug Levels and Safety of Luspatercept (ACE-536) for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes in Chinese and Japanese Participants With Ring Sideroblasts Who Require Red Blood Cell Transfusions

The purpose of this study is to evaluate the efficacy and safety of luspatercept (ACE-536) for the treatment of anemia due to Revised International Prognostic Scoring System (IPSS-R) very low, low, or intermediate risk myelodysplastic syndromes (MDS) in Chinese and Japanese participants with ring sideroblasts who require Red Blood Cells (RBC) transfusions.


Eligibility Criteria:
Inclusion Criteria:

* Refractory or intolerant to, or ineligible for, prior Erythropoiesis stimulating agent (ESA) treatment as defined by any one of the following: Refractory to prior ESA treatment, Intolerant to prior ESA treatment, or ESA ineligible.
* previously treated with an ESA or granulocyte colony-stimulating factor, granulocyte-macrophage colony-stimulating factor, both agents must have been discontinued ≥ 4 weeks prior to date of luspatercept treatment
* Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2

Exclusion Criteria:

* Prior therapy with disease modifying agents for underlying MDS disease
* Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding
* Serum aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) or alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT) ≥ 3.0 x upper limit of normal (ULN)

Other protocol-defined inclusion/exclusion criteria apply
Relative Bioavailability of Folic Acid and L-5-Methlytetrahydrofolate

Folic acid, a form of the vitamin folate, is added to grain products in Canada to help reduce birth defects. Folic acid is the synthetic form of folate and is very stable (doesn't break down) when added to foods. There are emerging health concerns about chronic folic acid consumption. Recently another more natural form of folate, L-5-methyltetrahydrofolate (L-MTHF) has become available. The investigators plan to conduct a randomized trial in women to determine if supplements containing L-MTHF consumed over three months raises blood folate levels as much as supplements containing folic acid. The investigators hypothesize that L-MTHF will increase red cell folate over 12 weeks to same extent as equimolar folic acid.

The proposed study is a twelve week, cross-sectional, double blind, randomized controlled trial. The sample population will consist of one-hundred fifty healthy adult volunteers. All participants will be Malaysian women between eighteen and forty-two years of age. Study participants will be recruited by word of mouth and through advertisements placed in hospitals and universities starting in January 2011. Study participants will be randomly assigned to 1 of 3 treatment groups: 1) 1000ug L-MTHF 2) 1000ug folic acid 3) placebo (methyl cellulose). All treatments will be given in capsule form. Blood samples will be collected at baseline, 6 and 12 weeks.

The primary outcome measure is red cell folate. A sample size of 45 subjects per group will allow us to detect a minimum difference of 100 nmol/L red cell folate assuming an alpha 0.05, a beta of 0.8 a SD of 183 nmol/L. Accounting for a 10% attrition rate we will enroll 50 women per group. The study will be analyzed as intent to treat. Baseline characteristics and compliance between treatment groups will be compared using a one-way ANOVA for continuous variables and chi-square analyses for categorical variables. The difference in measurements between the treatment groups at week 12 will be determined by regression analysis, controlling for baseline values.

Eligibility Criteria:
Inclusion Criteria:

* Malaysian nationality

Exclusion Criteria:

* Pregnancy
* Vitamin supplement users
* Chronic disease
* prior neural tube defect affected pregnancy
Acute Gastroenteritis: Development of PCR Analysis and Algorithm for Fast Clarification of Isolation Indication

Isolation of contagious patients is expensive, requires more caregiver time, most of the patients perceive isolation as a mental strain and it has been shown that the level of care and observation is lower than in a normal ward. But isolation of contagious patients is necessary to protect other patients, hospital staff and relatives to prevent spreading of infection and, in worst case out-break.

There are different isolation regimes available depending on causative agent and mode of transmission. A community-acquired acute gastroenteritis (GE) is most often caused by Norovirus while a hospital-acquired acute GE is often caused by toxin producing Clostridium difficile. Patients infected with Norovirus or Clostridium difficile have to be isolated in single rooms with strict contact precautions. Patients infected with acute GE caused by other pathogens can be isolated in a multi-bed room if there is a private toilet.

However, at the time of arrival to hospital it is not known if the patient is contagious. The indication of isolation has to be made based of a clinical evaluation in risk of isolating to few or too many patients.

Aim of the study:

To identify anamnestic, clinical and paraclinical variables that can be used as indicators of the aetiology of infectious GE, thus giving an indication for isolation.

To clinically evaluate a combined RNA (Norovirus) and DNA (Clostridium difficile) fast PCR analysis test to identify infectious GE compared to gold standard methods.


Eligibility Criteria:
Inclusion Criteria:

* acutely admitted
* more than three Loose stool, or lest than three Loose stools and vomiting within the last three weeks

Exclusion Criteria:

* age under 18 years
Case Series Study of Biliary Tract Cancer Patients in Japan

To assess the difference of prognosis between unresectable and recurrent biliary tract cancer and evaluate prognostic factors.

Most patients of biliary tract cancer have advanced disease at diagnosis and often relapse despite surgery. Combination therapy of gemcitabine and cisplatin could be a standard therapy for this kind of cancer with the evidence of phase III study compared with gemcitabine alone. However the prognosis and the tolerability of chemotherapy in the patients with recurrent biliary tract cancer after radical resection might differ from those of unresectable biliary tract cancer, because the dose intensity of chemotherapy can be influenced by adjuvant chemotherapy and/or hepatic resection.

Eligibility Criteria:
Inclusion Criteria:

* Unresectable or recurrent biliary tract cancer

Exclusion Criteria:

* None
Orthopaedic Manipulation in Treatment of Adolescent Idiopathic Scoliosis

To examine the clinical efficacy of the Orthopaedic Manipulation Techniques of the Lin School of Lingnan Region in the treatment of Adolescent Idiopathic Scoliosis

After being informed about the study and potential risk, all patients giving written informed consent will undergo a 0-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a single-blind manner(participant) in a 1:1 ratio to Manipulation Techniques Group or Control Group.

Eligibility Criteria:
Inclusion Criteria:

1. Adolescents aged between 10 and 18 who can speak and read Chinese
2. Fulfil the diagnostic criteria of scoliosis, i.e. Cobb's angle ≥ 10 degree
3. Risser grade ranging from 0 to 4
4. Informed consent agreement signed by both subject and their parents/guardians
5. Able to participate in follow-up assessments

Exclusion Criteria:

1. History of spine surgery;
2. Cobb's angle \>30 degrees
3. Known to have severe respiratory or cardiovascular comorbidities; vertebral tumours and spinal canal abnormalities; Leukaemia, thrombocytopenia and other bleeding disorders
4. Known to have cognitive impairment.
5. Documented pregnancy
6. Wearing brace within 1 month.
7. Involved in other interventional clinical studies at the same time.
8. Uncooperative during treatments
9. Being assessed by investigators as unsuitable to participate.
Stratification of Oral Ulcers in Rheumatoid Arthritis Patients Kept on Methotrexate

This study included rheumatoid arthritis patients receiving Methotrexate as monotherapy. All eligible patients were subjected to thorough clinical examination and full history to identify oral events. Drug history, current dose and duration of MTX were recorded.

The current study was conducted in the Clinics of Oral Medicine, Faculty of Dentistry and Rheumatology, Faculty of Medicine - Cairo University from 2017 to 2019. This study followed the principles of the Helsinki Declaration and was approved by the Research ethics committee of Faculty of Dentistry, Cairo University.

RA patients receiving MTX as monotherapy were included in the study. Patients suffering from systemic disease known to cause oral manifestations; salivary gland diseases and malignancies were excluded.

All eligible patients were subjected to thorough clinical examination for the whole oral cavity. Medical history and history of any oral manifestation were recorded. Drug history, dose, and duration of MTX were recorded.

Categorical data was presented as frequencies and percentages. Continuous data was described as means and standard deviations. Means were compared by one-way ANNOVA and Student-t-test. The significance level was set at P ≤0.05. Statistical analysis was performed with IBM® SPSS® Statistics Version 25 for Windows.

Eligibility Criteria:
Inclusion Criteria:

* patients with Rheumatoid arthritis using methotrexate as sole treatment

Exclusion Criteria:

* patients with Rheumatoid arthritis using any other treatments for Rheumatoid arthritis
Use of a Low-cost Video Laryngoscope on Manikin

Videolaryngoscopy has become essential in airway management, providing improved glottis visualization and reducing intubation attempts. Proficiency in using videolaryngoscopes, especially those with hyperangulated blades, is crucial for challenging intubation cases. However, successful intubation with hyperangulated blades requires continuous training due to their unique shape. Despite the benefits, the high cost of commercial videolaryngoscopes limits their use, prompting the exploration of a cost-effective alternative-a self-built laryngoscope using a USB borescope. The study aims to compare its training effectiveness with a commercial hyperangulated blade videolaryngoscope, emphasizing accessible training options. The evaluation involves testing both devices on a Laerdal® intubation mannequin, focusing on the time to glottis visualization and the time to complete intubation.

Videolaryngoscopy has become integral in airway management, providing improved visualization of the glottis and reducing the number of intubation attempts. Proficiency in the use of videolaryngoscopes is essential, particularly in cases of difficult intubation. Videolaryngoscopes equipped with hyperangulated blades facilitate enhanced visualization, even in the most challenging scenarios. However, successful intubation using these blades requires adequate training due to their unique shape. While hyperangulated blades offer excellent views around the curvature of the tongue, their upward perspective from the base of the tongue can pose challenges in tube delivery. Therefore, continuous training is essential to achieve proficiency with these particular blades.

Despite the advantages, the high cost of commercially available videolaryngoscopes poses a barrier to regular use and training, especially in resource-limited settings. This study introduces a cost-effective alternative-a self-built laryngoscope using a Universal Serial Bus (USB) borescope. The objective is to compare its training effectiveness with that of a commercial hyperangulated blade videolaryngoscope, underscoring the significance of accessible training options.

The Glidescope videolaryngoscope and a custom-built laryngoscope equipped with a USB borescope blade will undergo testing. The evaluation will be conducted by 30 emergency and operating room personnel following a brief training course in videolaryngoscopy, using a Laerdal® intubation mannequin. Both devices will utilize size 4 hyperangulated blades with identical curvature angles. Assessment endpoints will encompass the duration required for glottis visualization and the time needed for the entire intubation process.

Eligibility Criteria:
Inclusion Criteria: emergency and operating room personnel who have participated and completed the videolaryngoscopy course -

Exclusion Criteria: any temporary or permanent physical impediment to performing the requested maneuver or not having participated or completed the videolaryngoscopy course

-
Frequency of Residual Neuromuscular Blockade in the Pediatric Population

This study is designed to investigate the frequency of Residual Neuromuscular Blockade (RNMB) in the pediatric population.

The proposed study will be the first to investigate the incidence of residual postoperative neuromuscular blockade in the pediatric patient following the intraoperative use of NMBA's. If there is significant residual blockade present, it may be that these effects will lead to postoperative respiratory complications including hypoxemia, atelectasis, and prolonged oxygen requirement resulting in a prolonged stay in the post-anesthesia care unit.

Eligibility Criteria:
Inclusion Criteria:

1. Age less than 18 years.
2. Surgery requiring the administration of neuromuscular blocking, agents with planned extubation in the postoperative care unit (PACU).

Exclusion Criteria:

1. Neuromuscular diseases which may prolong the duration of NMBA's or exaggerate the effects of residual blockade.
2. The need for postoperative mechanical ventilation.
3. Direct admission to the Pediatric ICU, NICU or CTICU.
Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction II

Rose Bengal Electromagnetic Activation with Green light for Infection Reduction II (REAGIR II) is a randomized, double-masked feasibility study. The purpose of this study is to determine differences in 6-month visual acuity between medical antimicrobial treatments alone versus antimicrobial treatment plus cross-linking with rose Bengal (RB-PDT).

Patients presenting to one of the Aravind Eye Hospitals in India or to the Federal University of São Paulo ophthalmology clinic in Brazil with smear-positive and/or culture positive typical (I.e. non-Nocardia or Mycobacteria) bacterial corneal ulcers and moderate to severe vision loss, defined as Snellen visual acuity of 20/40 of worse, will be eligible for inclusion. Those who agree to participate will be randomized to one of two treatment groups:

* Group 6, RB-PDT Plus Early Steroids: topical 0.5% moxifloxacin plus topical difluprednate 0.05% plus RB-PDT
* Group 7, Sham RB-PDT Plus Early Steroids: topical 0.5% moxifloxacin plus topical difluprednate 0.05% plus sham RB-PDT


Eligibility Criteria:
Inclusion Criteria:

* Corneal ulcer that is smear positive and/or culture positive (within 24 hours) for typical bacteria (i.e. non-Nocardia or Myobacteria)
* Moderate to severe vision loss, defined as Snellen visual acuity of 20/40 (6/12) or worse
* Corneal thickness ≥350 µm, as measured on AS-OCT
* Age over 18 years
* Basic understanding of the study as determined by the physician
* Commitment to return for follow up visits

Exclusion Criteria:

* Evidence of concomitant infection on exam, gram stain, or confocal microscopy (i.e. herpes, both bacteria and acanthamoeba on gram stain)
* Impending or frank perforation at recruitment
* Involvement of sclera at presentation
* Presence of desmetocele at recruitment
* Non-infectious or autoimmune keratitis
* History of corneal transplantation
* History of intraocular surgery within the last three months\*
* Pinhole visual acuity worse than 20/200 in the unaffected eye
* Participants who are decisionally and/or cognitively impaired
Study of Cardiac PET/CT Imaging to Guide Ablation Treatment of Ventricular Tachycardia

Imaging is to be performed prior to procedure using positron emission tomography/ computed tomography (PET/CT), after a special dye is injected. The scans are going to be merged with other cardiac scans when doing the ablation procedure to correlate anatomy with physiology.


Eligibility Criteria:
Inclusion Criteria:

* Clinical indication for ventricular tachycardia (VT) ablation (at least one clinical episode of sustained VT) despite antiarrhythmic drug therapy, or if the patient does not wish to be on one
* Ischemic or nonischemic cardiomyopathy
* Sustained monomorphic VT

Exclusion Criteria:

* Right ventricular VT
* Polymorphic VT or ventricular fibrillation (VF) being the sole detected clinical arrhythmia
* Patient is unable to sign informed consent
* Recent myocardial infarction less than 30 days
* Recent ablation for ventricular tachycardia less than 30 days
* Patient is unwilling or unable to cooperate with the study
* Prosthetic mitral or aortic valve
* General contraindications to VT ablation, e.g., major contraindication to anticoagulation therapy, known presence of left ventricular thrombus, reversible causes of VT or VF
* General contraindications to PET imaging, e.g., pregnancy or lactation
* General contraindication to magnetic resonance imaging or to the administration of gadolinium.
* Contraindication to the placement of hemodynamic support devices, i.e. the presence of mechanical valves or lack of adequate vascular access
Investigating Myocardial Remodelling in the Failing Human Heart

Despite improvements in therapy, heart failure is a disease with high mortality and accelerating prevalence. To improve patient care, it is necessary to better understand the features and underlying mechanisms of myocardial remodeling; how it manifests in vivo and its underlying cellular and extracellular changes. The RELAX study will offer insight into myocardial remodeling, by comprehensively assessing function and structure of failing human hearts, and investigate its underlying cellular and extracellular changes.


Eligibility Criteria:
Inclusion Criteria:

* Eligible for heart transplantation
* Willingness to participate in the present study and ability to understand and sign the written informed consent

Exclusion Criteria:

* Patients under the age of 18.