cyrilzakka/clinical-trials huggingface dataset:
Trigona Honey and Intestinal Microbiota Among Obese People

Objective :

Nutrition intervention is one of the approaches to deal with obesity. Natural honey with its polyphenol component has an impact on the intestinal microbiota and lipid profile. Intestinal microbiota such as lactobacillus and bifidobacteria produce exopolysaccharide which plays important roles against obesity. This research aims to assess the effect of Trigona biroi honey on body mass index, lipid profile, and microbiota profile

Design A Quasi-experimental study involving two arms (trigona honey) and control will be conducted. The outcome of interests are body mass index, lipid profile, and microbiota profile

Hypothesis using superiority trial, trigona honey will

1. improve microbiota (increase lactobacillus and bifidobacteria and reduce clostridium)
2. Improving lipid profile
3. lowering body mass index

Target population :

This study will recruit healthy participants with a body mass index of more than 27

allocation : non-random with propensity score matching

Arms

1. Trigona honey (intervention) composition : vitamin C 0.15%, Protein 1.32%, lipid 0.23%, carbohydrate 64.12%, beta carotene 10.61 ppm, Calcium 273,23, magnesium 338.94, zinc 12.49 ppm, and acidity 5.76. Total polyphenol 133.52 ppm, total flavonoid 159.62 ppm. This liquid has a sour profile
2. Active comparator Commercial honey with fructose, Glucose, pure honey (2,271%), citric acid, and lime extract (0,076%).

Intervention 8 weeks, once daily. This also applied to the control group

Outcome :

1. Microbiota detected using Polymerase Chain Reaction (PCR)

   1. Sample: Stool
   2. extraction with 70% ethanol primary PCR
   3. primer (Lactobacillus and bifidobacteria)
2. Lipid Profile using blood plasma and homogenous assay High-Density Lipoprotein, Low-Density Lipoprotein, Triglyceride, total cholesterol
3. Anthropometry Body mass index, body composition (fat percentage), waist circumference

Sample Size was calculated using the difference of HDL between groups with the following parameters :

Effect size =0.3 Type 1 error = 5% Power of Study = 80% dropout = 20% total participant 336

Analysis Intention to treat will be applied. The descriptive statistic will be used to describe the baseline characteristic of participants. The bivariate analysis will be conducted to see the association of demographic factors to the outcome. If the matching of the participant yields a similar baseline characteristic, the difference of mean between the two groups will be analyzed using an independent t-test. Otherwise, linear mixed model will be applied

Eligibility Criteria:
Inclusion Criteria:

1. Defined as obese with a body mass index of more than 27
2. Not having a gastrointestinal disease
3. Not allergic to the honey component

Exclusion criteria:

1. Consuming probiotics for a minimum of one month
2. Consuming antibiotics for a minimum of one month
Dexmedetomidine Added to Propofol for Drug Induced Sleep Endoscopy

This study evaluate the effect of adding dexmedetomidine intravenous infusion to propofol intravenous infusion during sedation for drug induced sleep endoscopy. Twenty five patients will receive propofol only while the other twenty five will receive propofol and dexmedetomidine.

Propofol is a commonly used intravenous anesthetic drug used for procedural sedation. Dexmedetomidine is an alpha 2 adrenergic receptor agonist which has a sedative and analgesic effects.In the current study the success of the sedation during drug induced sleep endoscopy will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* age more than 18 years
* patients with obstructive sleep apnea
* ASA 1and2

Exclusion Criteria:

* patient refusal
* age less than 18 years
* morbid obesity
* known or suspected allergy to the studied drugs
The Effect of a Digital Photograph of the Patient in a CT Scan Examination on the Quality of Diagnosis by the Radiologist

Whenever a scan is accessed through the PACS system a scanned document or digital picture may be displayed automatically. In this study the technician will take a digital picture of the patient who will be undergoing the CT scan. This way the radiologist will be able to view the patient's face before viewing the scan.

The hypothesis is that viewing a digital picture of the patient before viewing the CT scan will improve the quality of diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Patient who are to be scanned by ct

Exclusion Criteria:

* Disabled
Improving Latent Tuberculosis (TB) Diagnosis in Thai Children

The study is a prospective study to improve the diagnosis and management of latent TB in HIV-infected and HIV uninfected children in Thailand. The objectives are to assess the sensitivity and specificity of IGRAs (T-Spot®.TB, a T-cell-based assay, and QuantiFERON®-TB Gold In-tube, a whole blood assay), TST, and a refined symptom-based questionnaire in diagnosing latent TB in 166 HIV-infected and HIV uninfected children in Thailand, and to evaluate the influence of age, nutritional and immune status on children's response to the IGRAs. These children will be screened for TB with a detailed TB contact history, symptom-based questionnaire, physical examination, TST, chest radiograph (and abdominal ultrasound for those with abdominal symptoms), IGRAs, and clinical specimens for acid fast bacilli stain and culture. A diagnostic algorithm will be generated using the combination of test modalities with the highest sensitivity and specificity results.

Study Objectives

* To compare the utility of IGRAs, T-Spot®.TB and QuantiFERON®-TB Gold In-Tube, and TST for screening of latent TB in HIV-infected children
* To compare these different screening modalities in HIV-infected children to HIV uninfected children
* To assess the influence of age, nutritional and immune status, prior BCG and TST status on children's response to IGRAs
* To assess the prognostic value of IGRAs vs. TST in predicting development of active TB in children over 9 months

Research questions:

Primary:

What is the sensitivity and specificity of IGRAs and TST in screening for latent TB in HIV-infected and HIV uninfected children in Thailand?

Secondary:

How do age, nutritional and immune status, prior BCG and PPD status influence children's response to IGRAs? What is the prognostic value of IGRAs vs. TST in predicting development of active TB in children over 9 months?

This is a prospective cohort study conducted at two sites in Bangkok, Thailand: HIV Netherlands Australia Thailand (HIV-NAT) Clinic/Chulalongkorn Hospital and Queen Sirikit National Institute of Child Health.

Eligibility Criteria:
Inclusion Criteria:

1. Have close contact with a person \> 15 years of age who had active pulmonary (± extrapulmonary), sputum AFB positive TB (household member or non-household member with contact \> 120 hours/month) during the past year
2. Are between the ages of 2 months and 16 years
3. Parents or caregivers provide informed consent to participate
4. Provide child assent for children aged ≥ 7 years

Exclusion Criteria:

1. Child and/or parent/caregiver who refuse study participation
2. Are currently receiving antituberculosis medications for TB disease
3. Have recently been diagnosed with active TB within past 6 months
Virtual Reality Exposure Therapy for Public Speaking Anxiety

Virtual Reality exposure therapy (VRET) is an efficacious treatment for anxiety disorders but has yet to be implemented in regular care settings. This is arguably due to the limitations of the past generation of VR technology, which was expensive, inaccessible, cumbersome and hard to use. With the advent of consumer VR technology, VRET is now ready for implementation in regular care. This multiple-baseline trial will examine the effectiveness of VRET for public speaking anxiety (PSA) when delivered under real-world conditions at an ordinary, non-specialized mental health clinic, by clinical psychologist with only brief VRET training. Participants will either be self-referred specifically for this treatment, or come through ordinary clinical channels. Self-rated PSA will serve as primary outcome measure and will be measured three times prior to treatment (at screening and twice after a diagnostic screening telephone interview) , four times after onset, at the end of the treatment period, and three months after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Have substantial public speaking anxiety (PSAS \>= 60)
* Can travel to PBM clinic on one occasion and pay stipulated patient fee
* Can speak and understand sufficient Swedish
* Have stable access to the internet

Exclusion Criteria:

* Deficits in sight or balance impacting the VR-experience
* A severe psychiatric disorder better treated elsewhere, including current major depression, alcohol or drug abuse, bipolarity, psychosis or similar
* Active psychopharmacological treatment, unless stable for last 3 months
* Other ongoing psychological treatment
Predicting Functional Outcome and Response to Therapy of Anti-NMDAR Encephalitis at Diagnosis

The goal of this international cohort study is to develop a prediction model for long-term outcome and response to first-line immunotherapy of anti-NMDAR Encephalitis, already at the moment of diagnosis.

Anti-NMDARE is a severe, but treatable neurological condition, with considerable and variable long-term disability. The previously developed anti-NMDAR Encephalitis One-Year Functional Status (NEOS) score predicts outcome a month into treatment. To predict outcome and response to immunotherapy at the time of diagnosis would be a serious improvement. This would timely identify patients in need for aggressive treatment and avoid harmful side-effects in those with good outcome. International data from five anti-NMDAR encephalitis cohorts will be combined to attain these goals.

The investigators strive to have less than 10% missing data on all variables and will impute data were needed. The datasets will then be split - with equal distributions of cohorts and good/poor outcome - to develop (70%) and validate (30%) the NEOS2 model. The primary outcome is functioning one year after diagnosis. A secondary analysis is targeted to predict the effect of first-line therapy. Potentially relevant predictive variables are identified with a univariable analysis on the original data, confirmed with backwards selection on the imputed datasets. After checking for multicollinearity and linearity of the variables, identified variables are added to a mixed effects logistic regression model on the original and imputed datasets, to identify the final set of predictive variables. To make the models opportune for daily medical practice, the investigators will assign points to (categories of) the included variables, based on the coefficients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with anti-NMDAR encephalitis (according to the Graus criteria)

Exclusion Criteria:

* Preceding Herpes Simplex encephalitis
* Premorbid dependency (modified Rankin Scale \> 2)
Effect of Probiotic Supplementation on Immune Function in Healthy Infants

The purpose of this study is to understand how a probiotic might change the immune response of healthy infants.

PROBLEM OF INTEREST: Lactic acid bacteria known as probiotics have been given to children and adults to prevent and treat gastrointestinal infections and to maintain intestinal health. This pilot study will collect information (biomarkers) of inflammation and immune response from healthy infants.

HOW THE PROBLEM WILL BE STUDIED: The investigators will give an active Lactobacillus-containing probiotic or an inactive placebo without Lactobacillus to 38 healthy infants in the metropolitan Atlanta area from 2 weeks before until 2 weeks after they complete their rotavirus vaccine series. Half will be assigned to receive the active probiotic, half to receive the placebo. Neither the investigators nor the parent/ guardian of the study subject will know whether their infant is receiving the probiotic or placebo. A teaspoon of blood and a stool sample will be collected from each infant before they start taking the active probiotic or placebo and 2 weeks after they complete their rotavirus vaccine series. Each infant will receive the probiotic or placebo product for 2 weeks before starting their rotavirus vaccine series until 2 weeks after they complete their rotavirus vaccine series. The blood and stool samples will be examined for levels of inflammatory markers and measures of immune response. The stool samples may be stored for the later study of probiotic bacteria as well as for other bacteria and viruses. These results will help to determine if this Lactobacillus containing probiotic has an effect on immune response and inflammation in healthy infants.

HOW RESEARCH WILL ADVANCE SCIENTIFIC KNOWLEDGE AND HUMAN HEALTH: This study will provide new information about the impact of giving a Lactobacillus-containing probiotic supplement to healthy infants. CURRENT STANDARD OF CARE: The current standard of care is for infants to receive a probiotic at the discretion of their caregiver. By studying probiotic administration in a controlled way with a fixed dose schedule and a well categorized probiotic, and measuring blood and stool markers, the investigators hope to better understand the impact of a probiotic on immune response and inflammation.

Eligibility Criteria:
Inclusion Criteria:

* Healthy infant
* Eligible for rotavirus immunization series
* No recognized immunodeficiency
* Ability to comply with study procedures

Exclusion Criteria:

* Ineligible for rotavirus immunization series
* Recognized immunodeficiency
* Inability to comply with study procedures
Efficacy of Guided Biofilm Therapy in Pediatric Patient

The present parallel randomized clinical trial aims to assess the efficacy of a plaque disclosing agent (PDA) and air-flowing with erythritol powder (Guided Biofilm Therapy) in the removal of biofilm and plaque in paediatric participants during professional oral hygiene, compared with ultrasonic debridement.

The participants will be divided in four groups and receive:

* Guided Biofilm Therapy with plaque disclosing agent (GBT+)
* Guided Biofilm Therapy without plaque disclosing agent (GBT-)
* Ultrasonic debridement and polishing with plaque disclosing agent (US+C+)
* Ultrasonic debridement and polishing without plaque disclosing agent (US+C-)

Clinical and image software analysis (ImageJ) of residual plaque will be performed.

Oral biofilm is not easily detectable visually, so its removal can be difficult. Using a plaque disclosing agent to highlight biofilm and plaque could aid during its removal and may be beneficial.

In paediatric patients, often times it is more difficult to perform professional oral hygiene because of lack of compliance. Our hypothesis is that the visual guide of the plaque disclosing might help obtaining a better result in terms of plaque removal. Moreover, the use of air-flowing could lead to several advantages compared to traditional professional oral hygiene (ultrasonic debridement and polishing cups), such as increased comfort and compliance, shorter treatment time, easier access to difficult areas and the minimal-invasiveness on soft and hard tissue.

The study is a mono-centric, pragmatic, single-blinded, randomized clinical trial (RCT) of parallel design.

The primary outcome is the Residual Plaque Area (RPA) expressed in percentage of area with residual plaque highlighted by disclosing plaque agent. Secondary outcomes are Full Mouth Plaque Score (FMPS), treatment time and participants' feedback.

Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent Form (pediatric patient and parent).
* Male and female subjects, aged 6 -12 years, inclusive.
* Good general health (ASA I e II)
* With at least 80% of dentition present
* With at least 8/12 frontal dental elements.

Exclusion Criteria:

* Not willing to follow the agreed protocol.
* Presence of orthodontic appliances.
* Tumors or significant pathology of the soft or hard tissues of the oral cavity.
* Current radiotherapy or chemotherapy.
* History of allergy to Erythritol.
* History of adverse reactions to lactose or fermented milk products.
Emergency Surgery Versus Colorectal Stents for the Management of Malignant Colonic Obstructions

The study evaluates and compares effect of emergency surgery and colonic stents for treatment of malignant colonic obstructions.

Acute colonic obstruction is one of the common clinical presentations of colorectal cancer. Surgical decompression with colostomy with or without resection and eventual re-anastomosis is the treatment of choice; however, emergency surgery is associated with higher morbidity and mortality.

The colonic stent insertion effectively decompressed the obstructed colon and avoid needs of emergency surgery. This method is a palliation and bridge to surgery. Colonic stents allowed surgery to be performed electively.

Eligibility Criteria:
Inclusion Criteria:

* Patient with malignant colorectal obstructions.
* Patient's approval to participate in the study.

Exclusion Criteria:

* Patient's preference for either treatment method.
* Patient's refusal to participate in the study.
* Patients in the ASA group 4 and 5.
Antibody Production Following H1N1 Influenza Vaccination After Stem Cell and Heart Transplantation

Stem cell and and heart transplant patients will receive pandemic H1N1 influenza vaccination according to the clinical guidelines.

In these patients the investigators will measure the specific antibody production.

Stem cell and and heart transplant patients will receive pandemic H1N1 influenza vaccination according to the clinical guidelines. Two doses will be given, in 3-week interval.

In these patients we will measure the specific antibody production. Blood sample 5 ml will be drawn before the first vaccine, before the second, and 3-4 weeks after the 2nd dose.

Eligibility Criteria:
Inclusion Criteria:

* Stem cell and and heart transplant patients who will receive pandemic H1N1 influenza vaccination according to the clinical guidelines.

Exclusion Criteria:

* Patients with unstable grafts.
Comparing Effects of Beetroot Juice and Mediterranean Diet on Liver Enzymes and Sonography in Patients With NAFLD

The goal of this clinical trial study is to investigate comparing Effects of Beetroot juice and Mediterranean diet on Liver Enzymes and Sonographic appearance in Patients with Non-Alcoholic Fatty Liver Disease (NAFLD)

The main question\[s\] it aims to answer are:

1. Beetroot juice has role in reduce Liver Enzymes
2. Mediterranean diet has role in reduce Liver Enzymes

Patients with NAFLD were identified and enrolled for this research at the PAR hospital in the Kurdistan Region of Iraq.

For 12 weeks, for the group members who were receiving the MeD, we recommended consuming Mediterranean foods like fish, poultry, sources of omega-3, vegetables and colored fruits, legumes and nuts, and low-fat goods while avoiding inflammatory foods like high-fat foods, processed meats, fast food, simple sugars, chips, and soft drinks.

At baseline, the participants' demographic and anthropometric information, including as gender, age, weight, height, smoking status, location of residence, and physical activity, were recorded.

Eligibility Criteria:
Inclusion Criteria:

1. Patients had to be between the ages of 19 and 73, and they had to have NAFLD as their main diagnosis.
2. For a NAFLD diagnosis, ultrasound proof of fatty liver (stage I or above) and an elevated level of liver enzymes were required.

Exclusion Criteria:

1. history of diseases like cardiovascular, liver, chronic hepatitis C, and kidney disease
2. supplement use within the previous six months; hormone therapy; use of drugs like amiodarone, methotrexate, and corticosteroids
3. cases of starvation or inadequate nutrition; pregnancy; metabolic disorders like Wilson disease and glycogen storage disease; a history of liver irradiation
Cohort Study of Clinical and Neuroimaging Characteristics for BPPV Patients in China

The main objective is to analyze the abnormality of physical condition, mental health and blood examination of the patients with benign paroxysmal positional vertigo (BPPV). Besides, the investigators aim to establish a database of BPPV based on multimodal magnetic resonance imaging data in the brain to identify high-risk patients with residual dizziness (RD) and systematically establish the comprehensive assessment system for the precise diagnosis, treatment and recovery of RD, optimize the tactics of BPPV management in China.

This is an observational, longitudinal, and single-center study. Confirmed BPPV cases will complete the following programs before and after 1 and 6 months of treatment for exploring biological mechanism and predictive biomarkers of BPPV: 1) fill in the behavioral psychological scales, 2) submit blood samples at a local laboratory, 3) receive 3 times brain MRI scan. The healthy controls will complete the same programs as BPPV-group mentioned above only at the time of inclusion. The investigators will establish the brain MRI database containing neuropsychological scales and blood parameters of BPPV in China.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of BPPV/Healthy subjects who have not had BPPV

Exclusion Criteria:

* History of organic diseases in central nervous system and mental disorder, such as tumors, infections, depressive disorder, schizophrenia, etc. Claustrophobic
Ketone Esters and Metabolism During Recovery from Endurance Exercise

Infusion of beta-hydroxybutyrate can suppress endogenous glucose production, which may result in increased net liver glycogen storage. If ketone esters exert similar effects, then the increase in liver glycogen storage may have implication for recovery from exercise and subsequent exercise performance.

The aim of this study is to assess the effects of ketone esters ingested during recovery from exercise, on metabolism and subsequent exercise capacity.


Eligibility Criteria:
Inclusion Criteria:

* VO2max ≥ 45mL.kg-1.min-1
* Weekly aerobic training \> 3hours.
* 2years running experience.
* BMI \< 30kg/m2

Exclusion Criteria:

* \<18yrs or \>60yrs of age
* Habitual smoker within last 5 years.
* History of uncontrollable metabolic or respiratory disease.
* Currently taking medication, following a low carbohydrate or ketogenic diet, or consuming nutritional ketone supplements.
* History of Irritable Bowel Syndrome
Gluten-free Diet in Irritable Bowel Syndrome

To evaluate the effects of a gluten-free diet in irritable bowel syndrome.

Irritable bowel syndrome with diarrhoea (IBS-D) is commonly encountered in primary and secondary-care practice. There are various triggers including diet. There is a growing number of people taking a gluten-free diet (GFD) of their own volition even in the absence of coeliac disease (CD). The investigators aim to assess whether a GFD could be of benefit to patients with IBS-D, previously naive to the effects of gluten and in whom CD has been excluded as per normal duodenal biopsies. The investigators will also assess whether certain factors may predict a clinical responder such as the presence or absence of at-risk coeliac serology.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 16 years or over
2. Patients fulfilling ROME III symptom based criteria for IBS-D but do not have coeliac disease

Exclusion Criteria:

1. Patients diagnosed with coeliac disease
2. Patients already on a gluten-free diet
3. Patients initially referred with self-reported gluten sensitivity
4. Patients with organic conditions that can mimic IBS-D such as idiopathic bile acid diarrhoea, pancreatic insufficiency, microscopic colitis, and inflammatory bowel disease