cyrilzakka/clinical-trials huggingface dataset:
Prospective Multicentre Study on Symptoms in First-onset Bronchial Asthma in Children and Adolescents

Bronchial asthma may present with symptoms other than the commonly reported complaints (cough, chest tightness, shortness of breath and wheezing). Less common symptoms include chronic or recurrent productive cough, inspiratory dyspnoea or recurrent pneumonia. Children presenting with these symptoms are often diagnosed with asthma bronchiale and benefit from antiasthmatic management.

International guidelines for the diagnosis of bronchial asthma list cough, chest tightness, shortness of breath and wheezing as the four basic symptoms of asthma. The diagnosis of bronchial asthma is based on the presence of two or more of these symptoms over time, together with evidence of bronchial hyperresponsiveness and a favourable response to antiasthmatic treatment. In children under 5 years of age, the occurrence of an isolated cough as a possible asthma symptom (cough variant asthma) is also accepted if bronchial hyperresponsiveness is documented and the difficulty subsides on therapy. Pulmonologists also refer children over 5 years of age who have only an isolated cough with no other symptoms before diagnosis.

In practice, however, it is also possible to see children whose asthma initially manifests as conditions assessed as recurrent pneumonia, isolated chronic cough of a moist nature or as inspiratory dyspnoea. These atypical symptoms are not oficially counted as asthma symptoms. In this study, the investigators focus on prevalence of typical and atypical asthma symtpoms. Furthermore, the investigators study sensitivity of offical asthma symptom questinaire ISAAC in children with typical and atypical asthma symptoms.

Eligibility Criteria:
Inclusion Criteria:

- Child 3 - 18 years old, first evaluation in pulmonary outpatient clinic for any of the following respiratory symptoms: cough, shortness of breath, chest tightness, wheezing, recurrent lower respiratory tract and lung infections, dyspnoea of any type, pathological listening findings.

Exclusion Criteria:

* Other documented chronic respiratory, cardiovascular, neurological, genetic, infectious, metabolic disease, significant immaturity or other disease that may be accompanied by respiratory symptoms.
Analysis of the Role of T-cell Response in Patients With Atrial Fibrillation for Clinical Application

The purpose of this study is 1) to characterize T-cell response in patients with atrial fibrillation, and 2) to analyze the changes of T-cell response after radio-frequency catheter ablation of atrial fibrillation. First, immune-phenotyping and cytokine profiling of T cells from patients with atrial fibrillation will performed. Next the difference of T-cell immunity among various type of atrial fibrillation patients will be analyzed. Finally the changes of T-cell response and cytokines after radio-frequency catheter ablation of atrial fibrillation will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Patients who consent with study
* patients with age more than19
* patients who undergoing catheter ablation of atrial fibrillation due to symptomatic, drug refractory atrial fibrillation

Exclusion Criteria:

* Patients who do not agree with study inclusion
* Permanent AF refractory to electrical cardioversion
* AF with rheumatic valvular disease
* Patients with left atrial diameter greater than 60mm
* Patients with age less than 19
* Patient with malignant tumor and chronic infection disease
* Patient are given immune inhibitor and steroidal anti-inflammatory drug within 2weeks
Resistance Training in Diabetic Elder Patients

The purpose of this study is to investigate the effect of a 12-week progressive resistance training program on the skeletal muscle function, glycemic control, functional capacity, and quality of life in the elderly with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* 65 years old or older
* no clinical diagnosis of cardiovascular disease
* patients with or without type 2 diabetes mellitus

Exclusion Criteria:

* glycated hemoglobin \> 10%
* pulmonary disease
* cancer
* cognitive dysfunction
* any neurological or musculoskeletal disease that will affect exercise performance
Effect of Genetic Variants on Fat-soluble Vitamin Bioavailability

The aim was to identify minor genetic variations (single nucleotide polymorphisms) that explain the interindividual variability in bioavailability of fat soluble micronutrients (fat soluble vitamins and carotenoids).

Healthy male volunteers were genotyped and submitted to 5 test-meals containing either no micronutrient of interest, 100 g tomato puree as a source of carotenoids, a lutein supplement, a vitamin E supplement or a vitamin D supplement. Blood samples were taken in the postprandial period (up to 8 hours after the test-meals intake) and the concentration of the studied micronutrients were measured in the chylomicrons. Multivariate analysis were then performed to identify single nucleotide polymorphisms that best explained the variance in the interindividual response (0 to 8 h area under the curve) in micronutrients.

Eligibility Criteria:
Inclusion Criteria:

gender : male age : 18 to 60 years old BMI: \[18 to 29.9\] kg/m2 Fasting Cholesterol concentration : \< 2,5 g/l Fasting triglyceride concentration \< 2 g/l Fasting glycemia ≤ 1,1 g/l Fasting Hemoglobin \< 13 g/dl HIV as well as hepatitis C and B negative

Exclusion Criteria:

smokers regular consumption of vitamin supplement \> 140 g/week alcohol vegetarian diseases drugs assumed to affect the metabolism of lipids or fat soluble micronutrients (e.g. ezetimibe)
CARES: A Mobile Health Program for Alcohol Risk Reduction

In this fast-track STTR, Phase 1 will develop and test a mobile phone app among 40 adult community college students. The app is designed to reduce risky drinking behaviors and improve user safety. In Phase 2 the app ("CARES") will be tested with 200 adult community college students who drink alcohol. Participants will be randomly assigned to the "CARES" app or an alcohol education control condition and will use the app for 12 weeks. Six month outcomes will assess changes in drinking related behaviors.

This STTR builds on our successful pilot that developed a text message-delivered alcohol intervention for, and in collaboration with CCS. Phase I will develop and test a smart phone application (the "Cares" app) incorporating the text message program with additional features and functionality requested by students in the pilot trial (Aim 1.1). After obtaining user feedback (Aim 1.2) programming will be completed in both iOS and Android languages. To ensure that the College Alcohol Risk Education System (CARES) is well positioned to get into the community college marketplace, it is critical to demonstrate efficacy. Phase 2 will conduct an efficacy trial of CARES compared to a competing alcohol education program that would be feasible for most community colleges to adopt, thus providing a real-world comparison with data suitable to support future efforts toward commercialization. This study will also identify the types of individuals for whom CARES is more/less effective and identify how it might be improved.

Eligibility Criteria:
Inclusion Criteria:

* Currently enrolled community college student
* At least 2 heavy drinking episodes in past 2 weeks at recruitment
* Own smart phone

Exclusion Criteria:

* Alcohol abuse disorder or currently in treatment for alcohol-related problems
Effects on CK, RPE, VAS Scale and Physical Performance of Three Recovery Methods in Elite Basketball Players

The aim of this study was to compare the effects of cold water intermittent ion (CWI), carbohydrate and protein supplementation (SUPPL), and active recovery (ACT) on creatine kinase (CK), perceptual and performance markers of recovery in elite basketball players after a specific fatigue protocol.

Fifteen elite basketball players participated in this crossover controlled trial. All participants were randomly measured in 4 conditions of the recovery method 1 week apart after a fatigue exercise protocol (\~ 45 'of high intensity intermittent effort with specific basketball movements). The recovery methods consist of CWI at 10oC in periods of 2 minutes submerged and 2 minutes out of the water, supplementation with 0.3gr / kg of maltodextrin and 0.2gr / kg of neutral whey protein in 0.5 liters of water, pedaling ACT for 25 minutes at 50% of maximum heart rate or a placebo drink (PLA). The Visual Analogue Fatigue Scale (VAS), Perceived Exercise Rate (RPE), CK and physical performance (jumping, speed, isometric and dynamic tests of resistance to squats) were measured before, after and 24 hours after of the protocol. The VAS scale and RPE were also measured immediately after application of the recovery method. Repeated 2-way post-hoc comparisons of ANOVA and Bonferroni measures were applied, with a significance set at P \<0.05.


Eligibility Criteria:
Inclusion Criteria:

* Having at least 10 years of sports practice,
* Having been training during the season a minimum of four times a week,
* Not having suffered serious or minor but recently injuries,
* Having competed and trained regularly in the previous season.

Exclusion Criteria:

* Suffering an injury during the study period
* Not having gone through all the treatment groups (CWI, carbohydrate-protein supplementation, active recovery and placebo)
Evaluating New Radiation Techniques for Cardiovascular Imaging

Title: Evaluating New Radiation Techniques for Cardiovascular Imaging

Background:

- Imaging studies such as computed tomography (CT) scans involve the use of radiation to create the pictures. Heart and blood vessel CT scans can cause high radiation exposure. Different methods of creating CT pictures have been developed to reduce the radiation dose. Researchers want to see how effective these new methods are in producing accurate CT scans.

Objectives:

- To study new ways of taking pictures of the heart or blood vessels using computed tomography.

Eligibility:

- Adults at least 18 years of age who will be having imaging studies to help detect heart or blood vessel problems.

Design:

* Participants will be screened with a physical exam and medical history. Blood samples will be taken to check kidney function.
* Participants will have a CT scan of the heart and blood vessels. A contrast agent may be used to improve the quality of the images. The scanning session may last up to 2 hours.
* Timing of and the need for follow up contact will depend on results from the initial scan and may be repeated to assess for late events. Telephone, office contact, or other follow-up of subjects may be done after CCTA to evaluate if the subject had subsequent cardiovascular testing. Further follow up will be based on reported test results.

Cardiac CT angiography is associated with radiation exposure. Different methods of creating CT pictures have been developed to reduce the radiation dose to the subject. The purpose of this research study is to learn whether these new imaging methods are accurate or predict subject outcomes.

Eligibility Criteria:
* INCLUSION CRITERIA:

  1. Clinical indication for a coronary CT angiography exam
  2. Age equal to or greater than 18 years
  3. Able to understand and willing to sign the Informed Consent Form
  4. Able and willing to provide follow-up information

EXCLUSION CRITERIA:

1. Pregnancy
2. If receiving intravenous contrast, severe renal excretory dysfunction, estimated glomerular filtration rate \< 30 mL/min/1.73m2 body surface area according to the Modification of Diet in Renal Disease criteria or as reported by the clinical lab. Glomerular filtration rate will be estimated using the 2021 CK-EPI equation that eliminate the use of race coefficient as reported in CRIS.

Screen Failures: Subjects who are screen failures can be re-enrolled once they meet eligibility criteria. Rescreened participants will be assigned the same participant number as for the initial screening.
Safety and Efficacy Study in Patients With Local Advanced Larynx/Hypolarynx Carcinoma Treated With TPF Induction Chemotherapy Followed by Hyperfractionated Radiotherapy With Cetuximab

To evaluate the progression free time in patients with completed or partial response \> 30% evaluated over primary tumour (damage T and N) after induction TPF (Docetaxel, Cisplatin, 5-FU) treated with RT + Cetuximab over 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Patient informed consent must be signed before to start the study.
* Age between 18 to 70 years.
* Performance Status 0-1 according to ECOG scale at the moment of inclusion.
* Life expectancy \>3 months.
* Confirmed anatomopathologic diagnosis of local advance scaly larynx or hypolarynx carcinoma III or IV stage without evidence of distance metastasis, which surgery involve a total laryngectomy.
* T3, T4A, T4B or T2 not candidate to a partial laryngectomy. In case of T2 of both locations it will be required III or IVA stage.
* Patients in medical conditions to receive neoadjuvant treatment with TPF followed by hyperfractionated radiotherapy combined with cetuximab.
* Presence of a injury measurable with RECIST criteria.
* Neutrophils \> or = 1500/mm3, platelets \> or = 150.000/mm3 and haemoglobin \> or =10 g/dL.
* Renal Function appropriate
* Hepatic Function appropriate
* Serum Calcium tight to albumine \< or = 1,25 x upper normal limit (UNL).
* Nutritional status appropriate: weight loss \< 20% and albumine \> or = 35 g/L.
* Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.

Exclusion Criteria:

* Metastatic disease.
* Surgical treatment, radiotherapy and/or previous chemotherapy.
* Another tumour locations in head and neck area different from larynx or hypo larynx.
* Another stages different from III or IVa without distant metastasis and resectable disease.
* Another previous scaly carcinoma
* Diagnosis of another neoplasia in last 5 years, except cervix carcinoma in situ and/or basocellular cutaneous carcinoma adequately treated.
* Active infection treated by ATB IV, including active tuberculosis and VIH.
* Hypertension not controled defined as systolic \> or = 180 mm Hg and/or diastolic \> or =130 mm Hg at rest.
* Pregnant/lactating women.
* Systemic immune treatment, chronic and concomitant, or cancer hormone treatment.
* Another antineoplastics concomitant treatments.
* Coronary artery disease or history of heart attack in the last 12 months or high risk of arrythmia uncontrolled or cardiac insufficiency uncontrolled.
* EPOC that required more than 3 hospitalizations in the last 12 months.
* Active ulcus not controled.
* Psychiatric illness/social situations that would limit compliance with study requirements
* Drug abuse (except alcohol abuse)
* Knowledge of Allergic to study treatment.
* Previous treatment with Monoclonal antibodies.
* Any experimental treatment in the previous 30 days to start the study.
Probiotics in the Treatment of Irritable Bowel Syndrome

The aim of the present study is to assess the efficacy of two different probiotic products, lacto-fermented sauerkraut and the supplement Mutaflor, in the treatment of irritable bowel syndrome.

Irritable bowel syndrome (IBS) is a chronic gastrointestinal (GI) disorder that affects around 11% of the population globally. Several factors have been implicated in the pathogenesis of IBS, including psychological stress, gastrointestinal motility, and diet. More recently, it has become clear that the gastrointestinal microbiota may play a critical role in the pathophysiology of this functional GI condition.

Gut microbiome manipulation, for example through the use of probiotic and prebiotic supplements, has shown some promise in the treatment of IBS. However, the research in this area is still in its infancy, and it remains unclear what type of intervention that is the preferred choice in cases of IBS. Many, if not most, probiotic supplements on the market today contain bacteria that are incapable of colonizing the human gut, which may partly explain why the health effects associated with the use of probiotics tend to be temporary, rather than permanent.

Several studies have investigated how the use of probiotic supplements containing Bifidobacteria and Lactobacilli affect the clinical outcome of patients with IBS. However, to date, no studies have assessed whether fermented vegetables, a "natural" source of probiotic bacteria, are useful in the treatment of IBS. Moreover, little is known about how other types of probiotic bacteria, such as those belonging to the genus Escherichia, affect symptoms of IBS.

Eligibility Criteria:
Inclusion Criteria:

Rome III criteria (Criteria fulfilled for the last 6 months with symptom onset at least 3 months prior to diagnosis):

Recurrent abdominal pain or discomfort at least 3 days/month in the last 3 months associated with two or more of the following:

1. Improvement with defecation
2. Onset associated with a change in frequency of stool
3. Onset associated with a change in form (appearance) of stool

Exclusion Criteria:

* Psychiatric disorder
* Metabolic disease
* Chronic infection
* Organic gastrointestinal disorder
* Pregnancy
* Breastfeeding
Aza With or Without ATRA in Newly Diagnosed Unfit AML or Intermediate,High or Very High Risk MDS

This is a randomized, open-label, multicenter study to compare the efficacy and safety of AZA with or without ATRA in newly diagnosed unfit AML or Intermediate,High or Very High Risk MDS

Newly diagnosed unfit AML and Intermediate,High or Very High Risk Myelodysplastic Syndromes (MDS) as Per IPSS-R Criteria are unable to tolerate the intensive chemo-therapy regimens due to their old age and poor physical condition, resulting in limited overall survival. Nowadays, AZA are recommended for unfit acute myeloid leukemia or myelodysplastic syndromes patients with remission rate of 30%\~34%. AZA with or without all-trans retinoic acid (ATRA) can cooperatively inhibit leukemia cell proliferation , induce apoptosis and differentiation.

Eligibility Criteria:
Inclusion Criteria:

* Chinese guidelines for the diagnosis and treatment of acute myeloid leukemia (2017 edition)，excludes acute promyelocytic leukemia (M3、APL) and myelodysplastic syndromes(2017 edition)
* Be at least 18 years of age on day of signing informed consent
* Not suitable for newly diagnosed patients with intensive chemotherapy
* Not suitable for newly diagnosed patients with receiving hematopoietic stem cell transplantation
* The proportion of blast cells was below 50% in bone marrow
* Total white blood cell (WBC) count ≤10,000/µL；Must be able to swallow tablets

Exclusion Criteria:

* Malignant neoplasms with other progression
* Serious mental illness uncooperative
* Refusal to join the study
Intravenous Lidocaine and Postoperative Outcomes After Cardiac Surgery

This study is being done to determine if lidocaine, administered during surgery and for 24 hours after surgery can reduce inflammation, thereby reducing the risk of atrial fibrillation and 30 day mortality after surgery. Participants undergoing cardiac surgery will be randomized to receive either lidocaine or placebo.

Subjects undergoing cardiac surgery are randomized into one of two groups.

* Group 1: Intravenous Lidocaine Group
* Group 2: Intravenous placebo Group

Either Lidocaine or placebo is administered throughout surgery and 24 hours after surgery.

Patients in both groups will undergo quality of life assessments and functional recovery assessments post-surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-90 years old
* Scheduled for cardiac surgery requiring cardiopulmonary bypass
* Written informed consent

Exclusion Criteria:

* Off-pump surgical procedures
* Anticipated deep hypothermic circulatory arrest
* Any contraindications to the proposed interventions including lidocaine allergy
* History of preoperative atrial fibrillation
* Baseline Screening revealing preexisting dementia or delirium
* Preoperative liver failure defined as Child-Pugh Score \> 6
RCT: The Effect of Held Position During Kangaroo Care on Physiological Parameters of Premature Infants

The goal of this superiority crossover randomised controlled trial is to investigate whether there is an optimal position at which to perform kangaroo mother care (KMC) in extremely preterm infants in the NICU. The main question it aims to answer is: 1) is there an optimal position for an infant to be held during KMC and 2) to optimise benefits for infants receiving KMC. Participants will be: 1) randomised into two groups which determine which angle they will start at first, 2) assessed over two hour-long sessions on different days with a change in the angle at the 30 minute point, 3) monitored using a Massimo NIRS machine which will record oxygen saturations, cerebral NIRS values and heart rates, and 4) monitored for any episodes of desaturations and bradycardias during this time. Participants will then be assessed beginning with the the other angle first on a different day. The researchers will then compare the two groups to see if being held at a 30 degrees during KMC is superior to being held at 60 degrees in terms of physiological stability.

In this proposed study the investigators will examine whether there is an optimal position in which to perform KMC. This will be performed by evaluating cerebral oxygenation with near infrared spectroscopy (NIRS). Cerebral Near-Infrared Spectroscopy (NIRS) is used as a non-invasive assessment of cerebral oxygenation and cerebral hemodynamics. NIRS gives an estimation of the regional cerebral tissue oxygenation via a probe attached to the baby's forehead. It is minimally invasive and won't interrupt any of baby's cares or interrupt time with parents. The investigators will use NIRS to specifically examine whether there is a difference in physiological parameters between being held when the Mother/Father is at a 30 degree or 60 degree angle on the bedside recliner and whether better oxygenation is associated with one position over another. Currently there are no studies assessing the optimal position to carry out KMC in neonatal units. This study proposes to help answer a question which has not yet been answered in the literature.

Eligibility Criteria:
Inclusion Criteria:

* Ex-premature infants who are a minimum of 28 weeks corrected gestational age
* Minimum weight at assessment for entry to study 600g
* Signed informed consent form

Exclusion Criteria:

* Corrected gestational age under 28 weeks
* Known neurological anomalies (not intraventricular Haemorrhage)
* Known orthopaedic conditions
* Known chromosomal anomalies