cyrilzakka/clinical-trials huggingface dataset:
Milk Oriented Microbiota

The purpose of this study is to determine if supplementing healthy term infants delivered vaginally who consume breast milk, formula, or both with a probiotic for 21 consecutive days increases levels of bacteria in infants' stool.

The purpose of phase 1 of this two phase clinical trial is to determine: 1) the effect of decreasing levels of human milk oligosaccharides on fecal B.infantis during and after 21 days of supplementation with Evolve activated B.infantis using exclusively breastfed, mixed-fed and exclusively formula-fed infants; 2) determine the effect of Evolve activated B.infantis on fecal B.infantis levels in exclusively breastfed infants compared to pre-supplementation levels.

Eligibility Criteria:
Inclusion Criteria:

* Women with infants age 8 to 12 weeks
* Term infants born \>37 weeks gestation
* Mother-infant pairs who live within a 20-mile radius from UC Davis campus in Davis, CA or within a 20-mile UCDMC
* Women and infants who live in one location
* Infants born vaginally
* Infants who are either exclusively formula-fed, exclusively breastfed or mixed-fed
* Women who are mixed and formula feeding their infants who are willing to switch infant formulas and use the study's infant formula (Earth's Best Organic Infant Formula With Iron, Earth's Best) throughout the first two months of the study
* Women who are breastfeeding but introduce infant formula to their infants during the first two months of the study who are willing to use the study's infant formula (Earth's Best Organic Infant Formula With Iron, Earth's Best) for the first two months of the study

Exclusion Criteria:

* Women who have lived in the United States or other developed nation for less than 10 consecutive years
* Multiple infants born to one mother
* Plan to feed infants solid foods before infants turn 5 months of age
* Family history of cow milk or soy allergy and/or infants allergic to cow milk protein or soy
* Infants born by C-section
* Infants born with medical complications such as: respiratory distress syndrome, birth defects, and infection
* Infants who have taken antibiotics 4 weeks before enrollment and more than one course of antibiotics since birth
* Infants who have taken probiotics since birth
* Plan to administer probiotics to infants or use of probiotics other than the study supplement by infants for the first two months of the study
* Mothers who have a chronic metabolic disease or obesity
* Mothers who currently smoke or plan to resume smoking during the study period
* Infants who consume solid foods or other liquids other than breastmilk, infant formula or water
Assessment Of Liver and Spleen Fibrosis in Patients With Gaucher Disease Using Fibroscan

The investigated cohort will examine liver and spleen fibrosis in patients with Gaucher disease divided into two groups, naive GD patients and GD patients treated with ERT. As liver biopsy in these patients not recommended because the risk of bleeding using Fibroscan is a safe with diagnostic accuracy regarding the liver (\& Spleen) fibrosis. Estimating spleen fibrosis is an innovative approach in liver disease and Gaucher.

The evaluation of fibrosis with this new and safe method could avoid complications antiinvasive procedure in GD patients. The addition of fibrosis biomarkers will help for patients score evaluation. The finding of liver and spleen stiffness will be evaluated in native and ERT treated Gaucher patients in order to assess ERT effect on fibrosis.

The Aims are: 1) To assess liver and spleen stiffness measurement using fibroscan and evaluate liver and spleen fibrosis in patients with GD.

2) To compare the elastography in two cohorts of GD patients: ERT treated and naïve GD patients and two control groups of patients: healthy and Non Alcoholic Steatohepatitis (NASH) patients.

3) To correlate the elastography findings with clinical and laboratory data in the four patient groups focusing on Gaucher disease manifestations and GD severity. To compare the elastography in GD naïve and ERT treated patients.

The investigated cohort will include 4 groups of patients 20 probands in each group including: 1) Naïve GD patients 2) GD treated with ERT 3) Healthy control 4) Patients with NonAlcoholic Steatohepatitis( NASH) which are followed at hepatology unit of the Ziv Hospital and healthy controls.

Serum fibrosis markers will be tested including: Bilirubin ,GGT, Haptoglobin,AST,ALT .The findings of spleen and liver fibrosis will be correlated with disease severity usingZimran's Severity Score Index (SSI) liver function tests , serology for viral hepatitis, GDbiomarkers, hemoglobin, platelet levels, and a GD severity score.

Protein C will be measured in all groups of patients Protein C activity as it may be used as a sensitive marker of hepatocellular damage even in those patients with mild liver affection .Also Patients with cirrhosis possess an imbalance in pro-coagulant versus anticoagulantactivity due to increased factor VIII and decreased protein C.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Gaucher in treatment and without treatment.
* Healthy control.
* Patients with Non Alcoholic Steatohepatitis( NASH) which are followed at hepatology unit.

Exclusion Criteria:

• Active liver disease ,cirrhosis patients.
Health Habits and Cancer Risk Comparison Among Migrant Sri Lankans and Sri Lankans

Objectives:

General objective:

To determine how acculturation to United States has influenced the health and cancer risk among a US migrant Sri Lankan population.

Specific objectives:

1. To determine the prevalence of cancer and cancer related non-communicable diseases among Sri Lankan Sinhalese living in the greater Houston area.
2. To study the distribution of risk factors for cancer in this population.
3. To study the pattern of utilization of methods available for early detection of cancer in this population.
4. To study and compare the findings of this survey with that of the siblings of this population living in Sri Lanka.

A health survey among Sinhala adults living in Houston comparing the health and health habits between the Sri Lankans living in Houston and their close relatives living in Sri Lanka.

Eligibility Criteria:
Inclusion Criteria:

1. Sri Lankan Sinhalese adults (18 years of age or older) living in the greater Houston area but born in Sri Lanka
2. Siblings or the first cousins of the study participants living in Sri Lanka of same sex and of an age plus or minus 10 years

Exclusion Criteria:

1. Sri Lankan Sinhalese born in the US
2. Sri Lankan Sinhalese under 18 years of age
3. Participation in a M. D. Anderson sponsored focus group or survey regarding health within the past 6 months
Impact of Information About Booster Vaccination Against DTPolio at 25 Years on This Booster Vaccination's Realization

The aim of vaccination is to protect the patient against disease by stimulating his immune system. DTPolio is a tetravalent vaccine providing protection against pertussis, diphtheria, tetanus and polio.

In France, the vaccination schedule sets the vaccination recommendations applicable to people according to their age. In this schedule, a booster of DTPolio at the age of 25 is recommended.

The vaccination coverage for patients over 16 years of age is insufficient in France.

The aim of the study is to evaluate impact of information about booster vaccination against DTPolio at 25 years on this booster vaccination's realization.

Eligibility Criteria:
Inclusion Criteria:

* aged 25 years old in 2020
* without delivery of DTPolio vaccine in 2019 or 2020

Exclusion Criteria:

* None
Endothelin Blockade in Patients With Single Ventricle Physiology

Recent studies have shown beneficial effects of sildenafil in patients with single ventricle congenital heart disease. The purpose of this study is to determine whether Bosentan, a drug with similar effects, will have similar benefit in this patient population.

Patients enrolled in the study will take Bosentan. Baseline and follow up measurements will be collected then analyzed.

Eligibility Criteria:
Inclusion Criteria:

* At least 12 years of age
* Single ventricle congenital heart disease
* Require cardiac magnetic resonance imaging (MRI) for clinical purposes.

Exclusion Criteria:

* \< 12 years of age
* Pregnancy or women who may become pregnant (sexually active and unwilling to use birth control)
* Patients taking cyclosporin or glyburide
* Patients with baseline liver dysfunction (aspartate aminotransferase or alanine aminotransferase \> 3 times upper limit of normal)
* Contraindications to MRI (including pacemakers)
* Use of Bosentan within one month prior to enrollment
Effect of Sulthiame on EEG in Childhood Epilepsy Syndromes

The effect of sulthiame on EEG has been studied in epilepsy syndromes of childhood with sleep activation by comparing sleep EEG obtained at baseline and after 4 weeks of treatment. The aim of the study is to know if an effect is still identifiable after 2 weeks of treatment by performing sleep EEG recordings after 2 and 4 weeks of treatment, respectively.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of epilepsy syndromes of childhood with sleep activation
* Failure of at least two anti-epileptic drugs (AED)
* Sleep EEG performed in the last 7 days before inclusion and showing interictal epileptiform discharges (baseline EEG)

Exclusion Criteria:

* Previous trial with sulthiame
* More than 2 AED at inclusion
* Use of corticosteroids at inclusion
* Change in the anti-epileptic treatment in the 7 days before baseline EEG
Can a Digital Tooll Facilitate Shared Decision-making and Increase Self-efficacy in Vocational Rehabilitation?

The study investigates both the effects and the experienced value of the mobile application, MIRA, which is a combination of an electronic diary, a dialogue tool and a decision support tool. The individual user registers real-time data reported in a mobile application, e.g. pain, sleep, mood, social activities, work-related activities, based on the goals and condition of the individual user. In this study, users are citizens participating in vocational rehabilitation due to long term sick leave.

The purpose of MIRA is to support a positive and trustful relationship between the citizen and the professional, and to enhance user involvement and shared decision making in the course of rehabilitation. This happens through promotion of the citizens knowledge and understanding of their own health condition and increase his or her self-efficacy, i.e. their ability to cope with their health condition at work and in everyday life.

The study uses a combination of quantitative and qualitative methods, analysed both individually and in combination, where findings of the different methods are combined to provide a deeper understanding of the positive and negative effects of using MIRA in vocational rehabilitation.

In this way the study investigates both the effect of applying a digital tool, such as MIRA, on a number of quantifiable measures (using questionnaires), and at the same time the study explores what works for whom and why using qualitative and combined methods. In this way, the study aims to contribute with knowledge in a balanced manner, regarding the pros and cons of using digital tools with real-time self-reported data in rehabilitation.

The study aim will be fulfilled through the following sub-purposes:

1. To investigate the effect of using MIRA in a course of vocational rehabilitation in relation to the citizens' self-efficacy for pain and work and their experience of shared decision-making in the course of rehabilitation.
2. To investigate the citizens' experience with and perception of using a digital tool like MIRA in their course of rehabilitation.
3. To investigate the professionals' experience with and perception of using a digital tool like MIRA in the course of rehabilitation.
4. To investigate the mechanisms of effect of MIRA (i.e. what works for whom and why), through and integrated analysis of the findings of sub-purpose 1-3.


Eligibility Criteria:
Inclusion Criteria:

* Referred for a course of vocational rehabilitation at a multidisciplinary health care unit at a municipal employment department.
* On sick leave or unemployed due to musculoskeletal or stress-related disorders
* In the working age (18 - 68 years approximately)

Exclusion Criteria:

* On sick leave or unemployed for other reasons, e.g. psychiatric disorders or cancer;
* Under the age of 18 or older than 68 years (approximately)
* Not sufficiently familiar with Danish language to use the MIRA app as intended.
Optimized Oxygen Delivery During General Anesthesia in Newborn Infants

An open randomized control trial investigating the delivery of two levels of inspired oxygen to newborn infants during general anesthesia.

Eligible infants are infants of less than 44 weeks postconceptional age and without pulmonary disease or demand for supplemental oxygen or assisted ventilation. Control subjects receive current standard of care (anesthesia induction/pre-oxygenation with 80%, maintenance of anesthesia with 40%, and recovery with 80% inspired oxygen). Intervention subjects are maintained on room air throughout the procedure and supplemental oxygen added only if necessary according to the pre-specified oxygen saturation target. Subjects are monitored according to clinical protocols AND with cerebral oximetry (NIRS), transcutaneous measurement of partial pressure of oxygen (pO2), and blood-gas analyses. Blood and urine samples are collected for later analysis of markers for oxidative stress.

Eligibility Criteria:
1. Newborn less than 44 weeks postconceptional age
2. No pulmonary disease, no oxygen requirement, or assisted ventilation
3. No genetic syndrome
Pharmacokinetics of Telavancin in Normal and Obese Subjects

The purpose of this study is to characterize plasma and urinary concentrations of telavancin following intravenous administration of a single dose of telavancin in healthy subjects who are normal weight, overweight, and obese.

This study is a Phase I, open-label, single-dose pharmacokinetic study in healthy adult male and female subjects. Eligible subjects will be assigned to one of four groups based on their body mass index and total body weight. Subjects will receive a single dose of telavancin depending on subject's group as a 1-hour intravenous infusion. Serial blood and urine samples will be collected over 12 hours to determine serum and urinary pharmacokinetics of telavancin. Subjects will return for blood and urine sample collection at 24 and 48 hours. Safety evaluations will be assessed throughout the study and will include physical examination, vital sign monitoring, clinical laboratory tests, monitoring of adverse events, and markers of kidney injury.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult subjects, 18 to 50 years
* Nonsmokers within the last 1 year
* Weight \> 110 lbs

Exclusion Criteria:

* History of significant hypersensitivity reaction or intolerance to telavancin
* Aspartate or alanine aminotransferase \> 1.5 times the upper limit of normal
* Estimated creatinine clearance \<60 mL/minute and serum creatinine \>1.5 mg/dL
* Female subjects who are pregnant or breast feeding
* History of alcohol or substance abuse or dependence within the last 1 year
* Use of prescription or nonprescription drugs (unless hormonal contraceptives) within 7 to 14 days prior to telavancin administration
* Participation in a clinical trials within last 30 days
* Donated blood (\>500 mL) within the last 56 days
Endocrine Disrupting Chemicals and Hormones in ADHD

Attention-deficit/hyperactivity disorder (ADHD) is a common neurodevelopmental disorder in children and adolescents. Growth hormone and thyroid function are associated with both physical and neurocognitive development. Endocrine disrupting chemicals (EDCs) could disturb the normal function of endocrine systems, and further link to the pathophysiology of ADHD. In addition, whether methylphenidate for treating ADHD influences growth hormone and thyroid function of patients remains unclear.

Therefore, this study aims (1) to investigate the prospective role of EDCs, growth hormone and thyroid function in clinical manifestations of ADHD; and (2) to determine the influence of pharmacotherapy on growth hormone and thyroid function among patients with ADHD under a one-year methylphenidate treatment.

Methods: In this two-year study, we will recruit 120 patients with ADHD (aged between 6 and 16) and 120 age- and gender-matched control subjects. Blood (10 ml) and urine (10 ml) will be obtained from each participant to analyze the levels of EDCs (Phthalates, Phenols and Parabens), growth hormone and thyroid function (TSH, T3, Free T4, T4, growth hormone, IGF-1and IGF-BP3). Behavior symptoms (ADHD-RS and SNAP-IV) and neuropsychological function (WISC, CPT and CATA) of each participant will be assessed. Patients with ADHD will receive treatment in a clinical practice and then will be followed up for 12 months. At the 12th month, the same procedures as those performed at the baseline will be replicated for patients with ADHD.

This study will provide proof of the relationships of EDCs, endocrine systems and ADHD manifestations in clinical samples and further explain the biological pathogenesis of ADHD. In addition, this study will elucidate the influence of ADHD medications on growth hormone and thyroid function. Such information may become an important reference for future research and safety of pharmacotherapy for patients with ADHD.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ADHD aged between 6 and 16.
* The patients were either newly diagnosed with ADHD or had an existing diagnosis but had not taken medication for ADHD during the previous 6 months or more.

Exclusion Criteria:

* Patients with a history of major physical or additional psychiatric diseases
Systemic Pharmacokinetics Following Intravitreal Injections of Anti-VEGF

Comparable data for bevacizumab and aflibercept are lacking, as are studies comparing the systemic levels of ranibizumab, bevacizumab, and aflibercept and their relative effects on circulating vascular endothelial growth factor. In the present prospective study, the investigators evaluated serum drug levels and plasma free vascular endothelial growth factor (VEGF) levels in patients with neovascular age-related macular degeneration following intravitreal injections of ranibizumab, bevacizumab and aflibercept.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent for participation in this study
* Subjects with a diagnosis of neovascular age-related macular degeneration, diabetic macular edema, or retinal vein occlusion who are either treatment naïve or more than 4 months out from a prior intravitreal anti-vascular endothelial growth factor injection

Exclusion Criteria:

* Subjects unwilling to receive 3 monthly injections of anti-vascular endothelial growth factor as initial therapy
* Subjects who may need or have received systemic anti-vascular endothelial growth factor for oncology in the past year
* Subjects with history of another ocular disease other than neovascular age-related macular degeneration, diabetic macular edema, or retinal vein occlusion
* Subjects with history of vitrectomy
A Clinical Trial to Evaluate the Efficacy and Safety of HL301 Versus Umkamin Tab in Acute Bronchitis Patients

A Multicenter, Randomized, Double-blinded, Active-controlled, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of HL301 versus Umkamin tab. in acute bronchitis patients

Endpoint: BSS, The improvement and improvement rate of the tester for the treatment response, The satisfaction of the subject


Eligibility Criteria:
Inclusion Criteria:

1. Both gender, 19 years ≤ age ≤ 80 years
2. (Bronchitis Severity Score)\* ≥ 5point at Visit 2 (Randomized Visit)
3. Acute bronchitis within 48hr based on Visit 2 (Randomized Visit)
4. Those who can comply with the requirements of clinical trials
5. Written consent voluntarily to participate in this clinical trial

Exclusion Criteria:

1. Patients with respiratory and systemic infections requiring systemic antibiotic therapy
2. Patients with bleeding tendency
3. Patients who investigators determines to severe respiratory disease that would interfere with study assessment
4. Patients who were treated with oral systemic adrenocortical hormone or immunosuppressive drug within 4 weeks prior to Visit 2
5. Patients who were treated with oral antihistamines, ACE suppressive. or systemic/inhalative glucocorticosteroid within 2 weeks prior to Visit 2
Traditional Chinese Medicine Syndrome Identification in Paediatric Neurology

Traditional Chinese Medicine (TCM) has a history of more than two millenniums. It has been a common practice in China, Taiwan, Japan and Korea and is becoming increasingly popular worldwide in recent decades However, there is no general consensus for treatment of many diseases among TCM practitioners. In some specialties, such as neurology, there is not enough well documented case reports for practitioners to make reference with. Different practitioners may give different opinions according to their own experience and patients often feel frustrated about that.

Therefore, it is worth recording cases of neurological diseases, with accurate western medicine diagnosis and TCM theory explained. Possible TCM treatments can be suggested accordingly. Being an academic research supervised by western medicine doctor, this study can help to suggest more objective opinion with least conflict of interest.

Traditional Chinese Medicine (TCM) has a history of more than two millenniums. It has been a common practice in China, Taiwan, Japan and Korea. In recent decades, it is becoming increasingly popular worldwide(Victor S. Sierpina 2005). Studies in Hong Kong, showed that TCM is quite common among children in Hong Kong, with about a quarter of children consulting a pediatrician are concurrently using Chinese Medicine.(Lee 2006; Li 2006).

However, there is a lack of standardized protocol for treatment of many diseases among TCM practitioners. In some specialties, such as neurology, there is not enough well documented case reports for TCM practitioners to make reference. Different TCM practitioners may give different opinions according to their own experience and patients often feel frustrated about that.

Therefore, it is worth recording cases of neurological diseases, with accurate western medicine diagnosis and TCM theory explained. Possible TCM treatments can be suggested accordingly. Being an academic research supervised by western medicine doctor, this study can help to suggest more objective opinion with least conflict of interest.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving medical care in the Department of Paediatrics and Adolescent Medicine in Queen Mary Hospital or the Duchess of Kent Children's Hospital, and
* Patients (or their care takers) who are able to provide accurate information about their signs and symptoms

Exclusion Criteria:

* Patients (or their care takers) who are unable to report a reliable medical history
Blue Protocol Assessment

Acute dyspnea is a common disease in emergency medicine. Mortality remains high is estimated at 15%. One third of initial diagnoses before paraclinical examination are estimated to be inaccurate. Lung ultrasound is a quick and immediate examination. Also, it is provided and performed at the bedside. The " Blue protocol " was designed by Daniel A. Lichtenstein as a diagnostic aid in dyspneic patients. It allows to obtain a diagnostic in more than 90% of acute dyspnea. However there is no validation in emergency medicine.

The main purpose is to evaluate the interest of the " Blue protocol "in the management and orientation of the dyspneic patient


Eligibility Criteria:
Inclusion Criteria:

* age over 18 years
* dyspneic patient requiring management by an emergency physician
* information given and no patient opposition.

Exclusion Criteria:

* patient under a legal protection measure
* lack of social security