cyrilzakka/clinical-trials huggingface dataset:
An Innovative Probiotic Product With Antiallergic Properties

Allergic diseases are currently one of the most important problem in medicine. Research confirms that probiotics administered during the formation of the intestinal ecosystem and the maturation of the immune system can positively influence the development of antiallergic mechanisms. The aim of the present randomized, double-blind, placebo controlled study was to evaluate the efficacy of the mixture of probiotic Lactobacillus rhamnosus ŁOCK 0900, Lactobacillus rhamnosus ŁOCK 0908, and Lactobacillus casei ŁOCK 0919 in children up to the age 2 with atopic dermatitis and food allergy to cow's milk proteins. Children received the mixture of Lactobacillus strains for 3 months every day in the daily dose of a billion bacteria or a placebo (maltodextrin). Primary outcomes included the effects of probiotic treatment on the severity of symptoms assessed with SCORing atopic dermatitis (SCORAD) index. Secondary endpoints included assessment of total IgE and selected cytokine levels. Cytokines were evaluated in supernatants obtained from peripheral blood cultures of randomly selected 20 patients from each group. The primary and secondary outcomes were assessed at 3 time points: at baseline, after the finishing the administration of probiotic/placebo, and after 9 months of follow up.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of atopic dermatitis according to Hanifin and Rajka criteria,
* age under 2 years (24 months)
* the SCORAD index \>10
* suspected allergy to cow's milk protein

Exclusion Criteria:

* acute infections of skin,
* presence of other severe diseases
* treatment with systemic corticosteroids
* treatment with antibiotics for at least 6 weeks prior to study enrollment
* use of probiotics for the last 6 weeks prior to study enrollment
The Safety and Efficacy of Embotrap in Treating Acute Ischemic Stroke Patients

This is a prospective, multicenter, cohort study aiming to compare the safety and efficacy of Embotrap stent retriever to other stent retrievers without inner channel for acute middle cerebral artery occlusion (MCAO). All enrolled patients will be followed up at 90 days after randomization.

AIS due to large vessel occlusion (LVO) remains a substantial cause of mortality and morbidity. Recent guidelines have recommended MT as the first-line therapy for AIS-LVO in the anterior circulation. Thrombectomy using a stent retriever is safe and effective in the treatment of AIS. As a new generation of stent retriever, Embotrap stent retriever has a unique design including an open outer cage for clot capture and a closed inner channel for clot stabilization. Previous studies showed Embotrap stent retriever can achieve a successful recanalization of 88% and favorable outcome of 51%. Also, the Multicenter ARISE II Study showed the first-pass effect of EmboTrap stent retriever was 40.1%, higher than other stent retrievers, such as Solitaire FR and Trevo device. But most studies were single-armed without direct comparison. Thus, this prospective cohort study is designed to compare the safety and efficacy of Embotrap stent retriever with other stent retrievers without inner channel.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects with symptoms due to acute middle cerebral artery occlusion (MCAO) treated with MT with or without intravenous thrombolysis.
2. Premorbid mRS 0-2
3. Ages 18-80 years
4. NIHSS ≥6 at admission
5. The time from onset to groin puncture ≤ 24 hours
6. ASPECTS 6-10 on non-contrast CT (NCCT) scan, MRI or CT-Perfusion (CTP)
7. Informed consent approved by patients or acceptable patient surrogate.

Exclusion Criteria:

1. Any intracranial hemorrhage or severe cerebral infarction on CT or MRI (ASPECTS \< 6 points, core infarct volume ≥ 70mL or core infarct area \>1/3 middle cerebral artery territory).
2. Severe allergy to contrast media allergy and nitinol
3. Refractory hypertension (SBP \> 185 mmHg or DBP \> 110 mmHg)
4. Platelet count \< 30 x 10\^9 / L
5. Coagulopathy history or hemorrhage disorders disease
6. Concurrent participation in a study involving an investigational drug or device that would impact the current study
7. Evidence of intracranial hemorrhage or hemorrhagic transformation before thrombectomy
8. Unable to complete the study and follow-up due to mental disorders, cognitive or emotional disorders
9. Pregnant or lactating women
10. Anticipated life expectancy \< 6 months
11. Patients without a legally authorized representative to sign the consent form
12. For other reasons, the researchers believe that the patient is not suitable for enrollment
AR Enhanced Pictorial Warnings on Smoking Cessation

This pilot randomized controlled trail aims to test the effects of AR enhanced pictorial effects in harms of smoking and benefit of smoking cessation.

Conventional health warnings on smoking harms mostly include pictures showing smoking consequences such as lung diseases, peripheral vascular diseases, aging, skin lesions, and benefit of quitting such as improved cardiopulmonary functions, skin conditions and risk of diseases, etc. The effects of the information are limited by the generic messages, unattractive images, and lack of interaction. This proposal aims to enhance the "Warn" and "Advice" materials using mobile phone-based augmented reality (AR) technologies to provide personalized, interactive, and attractive images to encourage smokers to quit smoking.

Eligibility Criteria:
Inclusion Criteria:

* Hong Kong adults aged 18 or above;
* Smoke at least 1 cigarette daily in the past 30 days;
* Own a smartphone and familiar with instant messaging apps;
* Able to read and communicate in Chinese.

Exclusion Criteria:

* Participate in other smoking cessation services or projects
Polyunsaturated Fatty Acids in Patients With NAFLD.

Patients with metabolic syndrome and Nonalcoholic fatty liver disease (NAFLD) will be randomly allocated for the treatment with n-3 PUFA (3.6 g/day) or placebo for 12 months. At the beginning and at the end of the study basic clinical and anthropometric data, as well as parameters of liver steatosis and fibrosis will be tested.

Patients with metabolic syndrome and Nonalcoholic fatty liver disease (NAFLD) will be randomly allocated for the treatment with n-3 PUFA (3.6 g/day) or placebo for 12 months. At the beginning and at the end of the study basic clinical and anthropometric data will be recorded and the following parameters will be tested:

panel of biochemistry and liver function tests: triglycerides, cholesterol, HDLcholesterol, LDL-cholesterol, glucose, insulin, serum bilirubin, liver tests, thyroid hormones, bile acids and their metabolites, albumin, total protein.

Bioactive metabolites, Inflammatory markers Non-invasive serum markers of liver fibrosis and steatohepatitis. Hyaluronic acid, NAFLD fibrosis score, cytokeratine-18 fragments. Ultrasonography with non-invasive measurement of fibrosis and steatosis, magnetic resonance spectroscopy for visceral and liver fat determination.

Eligibility Criteria:
Inclusion Criteria:

* Patients with metabolic syndrome and NAFLD

Exclusion Criteria:

* Age below 18 years
* Gravidity
* Incompliance.
Clinically Relevant Asymmetry of Bispectral Index

BIS for monitoring depth of anesthesia is usually obtained unilaterally. Obtaining BIS bilaterally revealed side differences in previous studies. This study investigates the incidence of clinically relevant side differences of BIS during maintenance and emergence from anesthesia for ENT surgery in both adults and children.

BIS was measured bilaterally in 42 adults and 46 children during ENT surgery under general anesthesia using two BIS-Monitors. Side differences of more than 10% were defined as BIS asymmetries. An increase of BIS of more than 10% from the value at the time of finishing anesthesia administration on only one side followed by movement after stimulation was defined as clinically relevant.

Eligibility Criteria:
Inclusion Criteria:Children and adults during anesthesia for ENT surgery -

Exclusion Criteria:Neurologic or psychiatric disease

-
How Does Medical Clown Intervention Affect the Length of Hospitalization in Children With Pneumonia

Background and Objectives: Community-acquired pneumonia (CAP) is a leading cause of hospitalization in children. The hospitalization duration depends on factors as child's well-being, vital signs, need for parenteral treatments, and development of complications. Medical clowns (MCs) are known to assist in reducing pain and alleviating anxiety and have been integrated into many aspects of hospital treatment routines. The aim of this study is to evaluate the effect of MC intervention on length of hospitalization in children admitted with CAP.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of pneumonia.
* Ages 2-18 years.

Exclusion Criteria:

* Hemodynamically unstable patients.
* Other systemic comorbidities or chronic respiratory diseases
* Children from families unable to comprehend and sign an informed consent form.
The Effect of Two Different Video Showings on Pain and Anxiety in Children Undergoing Adenotonsillectomy

Purpose of the Research: The purpose of the research is to examine the effect of two different video presentations on pain and anxiety in children undergoing adenotonsillectomy.

Type of Research It is planned as a randomized controlled interventional type study to examine the effects of two different video presentations on pain and anxiety in children undergoing adenotonsillectomy.

Technology is an indispensable part of our age and daily life . When we look at the research, it is seen that educational interventional preparation programs increase the harmony between both children, parents and health professionals. The increase in children's self-control and the elimination of unrealistic expectations may be related to the trust in healthcare professionals. Studies indicate that educational video animations are the most effective non-pharmacological method in reducing anxiety . Video animations will be useful for children because they create sound and images. It is believed that video animations with educational content that are understandable to children are essential for children's education. It is believed that animation shown to children will reduce their anxiety.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 6-12
* Having adenotonsillectomy surgery
* Signing the informed consent form by the patient's legal guardian

Exclusion Criteria:

* Not being between the ages of 6-12
* Not having adenotonsillectomy surgery
* Failure to sign the enformel consent form by the patient's legal guardian
Acute Diverticulitis and C-Reactive Protein as a Prognostic Marker

The management of acute diverticulitis maybe better if we have prognostic markers of evolution.

Hypothesis: C-reactive protein maybe a good prognostic marker of evolution of acute diverticulitis.

The investigators need to know the values of C-reactive protein to predict evolution of acute diverticulitis.

A prospective observational study. All the patients with TC-diagnosis of acute diverticulitis (AD) had a C-reactive protein (PCR) in the initial blood test.

The investigators will predict evolution of AD with the PCR initial.

Eligibility Criteria:
Inclusion Criteria:

* Acute Diverticulitis

Exclusion Criteria:

* Other Abdominal Pathologies
AMENDTM Mitral Valve Repair System, Annuloplasty Ring Applied in a Transcatheter Method

A multi center study to evaluate the safety of the AMENDTM Mitral Valve Repair System and its ability to reduce mitral regurgitation. AMEND device is an annuloplasty ring implanted in a minimally invasive trans-catheter method.


Eligibility Criteria:
Inclusion Criteria:

* Patient age ≥18
* The patient requires mitral valve annuloplasty for mitral regurgitation without the need for concomitant cardiovascular surgical procedures
* NYHA functional capacity ≥2
* The subject is high risk to undergo a mitral valve surgery as assessed by the center heart team
* The patient is willing to comply with study procedures and is available to return to the implant center for follow-up visits.
* The patient is willing to provide Informed consent

Exclusion Criteria:

* Cardiac or non-cardiac major or progressive disease, which in the investigator's discretion produces an unacceptable increased risk to the patient.
* Life expectancy of less than twelve months.
* Heavily calcified annulus or leaflets.
* Previous or active endocarditis.
* Active infection.
* A previously implanted prosthetic mitral valve or annuloplasty ring/band.
* The patient is contraindicated to general anesthesia.
* Pregnant (urine HCG test result positive) or lactating patient.
* Drug or alcohol abuse.
* Participation in concomitant research studies of investigational products that will interfere with the study.
Listening Benefits From a Hearing-aid App, a Personal Sound Amplification Product, and a Hearing Aid in Hearing-impaired Listeners

Interest and demand for sound amplifiers are increasing due to the burden of purchasing hearing aids and technological advances in healthcare products, and the demand is expected to increase rapidly. For sensorineural hearing loss patients, who are subject to wearing hearing aids, it aims to compare the effect of hearing aid application and personal sound amplification product (PSAPs) compared to the hearing aids


Eligibility Criteria:
Inclusion Criteria:

1. Adults over the age of 20 who speak Korean as their mother tongue and have no mental or physical limitations in conducting test.
2. Hearing loss patients with a hearing threshold of 26 dB or higher in the four frequency (0.5, 1, 2, 4 kHz)
3. Those who do not have a history of neurological disease, cognitive disorder, learning disorder, or language disorder at the time of recruitment

Exclusion Criteria:

1. In case that communication is difficult, equipment cannot be handled, or it is difficult to cooperate with the inspection
2. Acoustic nerve lesions or central nervous system disease
3. Those suspected of having false hearing loss
4. Those who have secondary benefits related to clinical trials
Efficacy and Safety Study of Symbicort® Turbuhaler® Versus Oxis® Turbuhaler® in Chronic Obstructive Pulmonary Disease (COPD) Patients

The primary purpose of the study is to investigate if Symbicort is more effective than Oxis in increasing forced expiratory volume in one second (FEV1), measured at the clinics, in patients with COPD.


Eligibility Criteria:
Inclusion Criteria:

* A current clinical diagnosis of Chronic Obstructive Pulmonary Disease
* Documented Chronic Obstructive Pulmonary Disease symptoms for more than 2 years
* A smoking history of at least 10 pack years

Exclusion Criteria:

* History and/or current clinical diagnosis of asthma
* History and/or current clinical diagnosis of atopic diseases such as allergic rhinitis
HEV in Patients With Acute Non-A, Non-B, Non-C Hepatitis in Al-Rajhy University Hospital for Liver

Hepatitis E is the fifth known human viral hepatitis and is probably the most common cause of acute viral hepatitis in the world. The incidence of acute hepatitis E is estimated at 3 million human cases per year worldwide, with around 70,000 deaths. Most cases occur in endemic countries, but the number of cases in low-endemic areas has increased. HEV seroprevalence is high in developing countries, such as India and Southeast Asia, ranging from 27-80%. Acute disease mortality is 1-4%, with risk being higher in pregnant women and immunodeficient patients.

The four more prevalent genotypes are allocated into two groups. Epidemic hepatitis E includes genotypes 1 and 2, which are considered human viruses and have caused the epidemics of hepatitis. These forms are transmitted mainly by contaminated water and the fecal-oral route. endemic hepatitis E includes genotypes 3 and 4, which are considered swine viruses (common in domestic and wild pigs), capable of infecting humans as an accidental host and therefore considered zoonotics.

The course and clinical presentation of hepatitis E is highly variable. The detailed mechanisms that lead to the different clinical outcomes in hepatitis E are only partially understood. It is known that both viral factors (genotype and dose of inoculum) and host factors (presence of previous liver disease, pregnancy and distinct genetic polymorphisms) determine the course of infection. In most cases, hepatitis E causes self-limited illness, lasting from a few days to weeks, with an average of 4-6 weeks. However, in developed countries it can cause chronic disease with rapid progression to cirrhosis, especially in patients who are transplanted, have hematological malignancies requiring chemotherapy, or have infection with HIV.

Hepatitis E is an underdiagnosed disease, partly due to the use of serological tests with low sensitivity. Diagnosis can be made indirectly by detecting antibodies against HEV in the serum, or directly by detecting the genome of the virus in blood or other body fluids. The tests for anti-hepatitis E antibody screening are commercially available, but none of them has been approved by the Food and Drug Administration (FDA). Unfortunately, the sensitivity and specificity of these tests vary greatly and this could explain the discrepancies in rates of anti-hepatitis E antibodies published for the various populations studied. The tests for viral RNA in serum and feces are confirmatory, but still experimental.


Eligibility Criteria:
Inclusion Criteria:

* • Patients have clinical diagnosis of acute viral hepatitis as (recent onset of nausea, fever, fatigue, abdominal pain , hepatomegaly and abnormal transaminases (at least 2 fold higher than the upper normal level))

  * Post-transplant acute hepatitis

Exclusion Criteria:

* hepatitis A, B and C patients
* autoimmune hepatitis
* Alcoholism
* Treatment with hepatotoxic drugs
* Biliary disease
* Infection with CMV or EBV
* Taken ribavirin therapy
Evaluation of Cassia Fistula + Senna Alexandrina Miller in the Chronic Functional Constipation Treatment.

Primary Objective:

To evaluate the clinical efficacy of Naturetti (capsules) , considering the following criteria:

* Evacuation frequency during the treatment and follow-up period
* Consistency of stools during the treatment and follow-up period
* Global evaluation, regarding increase in frequency of evacuation and shape of stools.

Secondary Objective:

* Number of days without evacuation
* Proportion of evacuation with pain
* Proportion of evacuation with strain
* Proportion of evacuation with incomplete sensation
* Proportion of blocked stools
* Proportion of manual maneuvers to facilitate defecation
* Proportion of subjects that adhere to the diet recommended
* Proportion of the patients who have to use rescue medication
* Level of constipation improvement, according to the patient evaluation
* To evaluate clinical tolerability of the study medication by the continuous use
* To evaluate the occurrence of adverse events related to the study drug
* To identify any drug interaction.


Eligibility Criteria:
Inclusion criteria:

* Chronic functional constipation present, diagnosed by Rome III criteria.
* Present in most evacuations intestinal feces classified as Type 1 or 2 by the classification of Bristol.
* Women sexually active and reproductive age, using more than three months effective contraceptive method.
* Concordance, level of education and consciousness enough to cooperate with the completion of all study procedures.
* No contraindication to the use of medication in the study.
* Availability to attend all the visits of the study evaluation.

Exclusion criteria:

* History or presence of neurological disorders and / or metabolism.
* Persons with constipation caused by previous surgery.
* Presence of obstructive lesions in the gastrointestinal tract, including colorectal cancer.
* Irritable bowel syndrome or inflammatory bowel disease.
* Multiple Sclerosis
* Parkinson's disease
* Other abnormalities such as Hirschsprung's disease and Defecation Dissinrgica.
* Heart disease and / or hypertension.
* Continuous use of medication such as analgesics, anti-cholinergic (anti-histamines, antispasmodics, antidepressants, anti-psychotics), supplements with iron or aluminum, Opiates, Anti-hypertensive, CALCIUM CHANNEL BLOCKERS Preganglionic and blockers.
* Use of any other except the laxative rescue medication during the study.
* Subjects who do not confirm the diagnosis of ICFC during Phase I of the study.
* Pregnant or breast-feeding period.
* Laboratory tests outside the normal range, or the result is assessed as clinically significant by the Investigator.
* Body Mass Index (BMI) over 30.
* Participation in another clinical study within 30 days.
* Do not fill the correct Diary
* Any condition that in view of the researcher impossible the Subject to participate in the study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Docetaxel and Irinotecan in Gastric Cancer

To assess the role of docetaxel and irinotecan combination in second line gastric cancer. The primary end point is response rate. Secondary end points are toxicity, PFS and OS.

Gastric cancer is a major killer in oncology. The expected overall survival of metastatic patients is less than 2 years. Moreover, most of the patients develop cachexia and worsening of performance over time. As a result, many patients are not fit for second line treatment when eligible. There is currently no approved consensus for third line treatment regimen and in most of the patients it is usually best supportive care.

Irinotecan and docetaxel were tested as single agents or in combination with other drugs (e.g. FOLFIRI) in second line setting. However, the combination of these two drugs together was not tested before. Both agents are active in second line setting which is considered the last chance of the patient in view of lack of evidence in third line setting.

Eligibility Criteria:
Inclusion Criteria:

* Histopathological evidence of adenocarcinoma of the stomach
* Metastatic disease or locally advanced non-resectable disease
* Patients who received only one line of treatment
* Performance status 0,1,2 as per ECOG scoring system

Exclusion Criteria:

* Patients who received docetaxel or irinotecan before recruitment to this study
* Multiple comorbid conditions
* Liver or kidney impairment
* Severe cachexia (sarcopenia)
Correlation Between ADR of Screening and All Colonoscopies

The aim of the study is to compare ADR for colonoscopies from various indications and to find correlations between ADR of screening and all examinations.

ADR (adenoma detection rate) is generally accepted quality indicator and it is calculated from screening colonoscopies in patients over 50 years of age. For possible gaming with ADR for screening colonoscopies, monitoring of ADR for all colonoscopies is discussed nowadays.The aim of the study is to compare ADR for colonoscopies from various indications and to find correlations between ADR of screening and all examinations.

We want to retrospectively assess the quality indicators of all colonoscopies performed from January 2013 to December 2017. We want to calculate ADR for all colonoscopies in patients over 50 years of age excluding therapeutic, IBD, management of complications and sigmoidoscopies (screening, surveillance, diagnostic) and separately only for screening colonoscopies. Correlation analysis will be performed using Pearson´s correlation coefficient.

Eligibility Criteria:
Inclusion Criteria:

* people over 50 years of age coming for colonoscopic examination (screening, surveillance, diagnostic)

Exclusion Criteria:

* age under 50 years
* indication for colonoscopy: therapeutic, IBD, management of complications and sigmoidoscopies