cyrilzakka/clinical-trials huggingface dataset:
The Roles of Gut Microbiome in UTI Susceptible Women

Clinical trials on cranberry juice and UTI prevention yielded both positive and negative results for unknown reason. Gut microbiome in women affect the absorption and metabolism of cranberry bioactives. The variation of gut microbiome is a probable mechanism for metabolic polymorphisms and disparity in UTI prevention in women.

The American cranberries, especially cranberry juice, have used for centuries as a folk medicine to prevent urinary tract infections (UTI), which affect 50% of women in their lifetime. Over 40 clinical trials have been conducted in the last 20 years to verify the UTI preventatively activity of cranberry juices, but the results were contradictory. About 90% of UTI are initiated by the adhesion of uropathogenic E. coli (UPEC) on urinary tract epithelia. It was reported that human urine after consumption of cranberry juice inhibited the adhesion of UPEC. The A-type proanthocyanidins and xyloglucans are the presumed bioactives in cranberries, however, this is unlikely because these two classes of compounds have extremely low bioavailability in human body. Preliminary research suggested that women can be either "resistant" or "susceptible" to UTI depending on the inherent anti-adhesion activity in their urine against UPEC before consuming cranberry juice. Not all but a fraction of "UTI susceptible" women had increased urinary anti-adhesion activity after consuming cranberry juices. These women are classified as "responders" and others are "non-responders". The variation of gut microbiome is a probable mechanism for metabolic polymorphisms and disparity in UTI prevention. The objective of this trials is to identify gut microbes and anti-adhesive urinary biomarkers which significantly contribute to the anti-adhesion of UPEC.

Eligibility Criteria:
Inclusion Criteria:

* Healthy women participants;
* BMI 18.5-29.9 kg/m2;
* At least 110 pounds in weight

Exclusion Criteria:

* BMI≥ 30 kg/m2;
* Pregnancy and breast-feeding;
* Smoking, frequent alcohol use;
* History of any clinically important disorder that may interfere with interpretation of the results;
* Intake of medication that might influence the outcome of the study
Tidal Volume Challenge and Lung Recruitment Maneuver (TIDALREC): the Reliability of Pulse Pression Variation or Stroke Volume Variation on Fluid Responsiveness.

In order to predict fluid responsiveness in the operating room and therefore benefit of performing fluid administration to improve patient's hemodynamic status, it will test two ventilation strategies : the Tidal Volume Challenge (VtC) and the Lung Recruitment Maneuver (LRM).

The objective is to determine whether the variation of 2 parameters such as pulse pression variation (PPV) and stroke volume variation (SVV) during these 2 strategies, allows to predict fluid responsiveness in the operating room for any heavy surgery. All patients will benefit from the 2 ventilation strategies then a fluid administration, called " fluid challenge ", will be performed to discriminate the true responders and others. The order of the ventilation strategies will be determined by randomization.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for major abdominal, vascular or neurosurgery requiring invasive arterial monitoring of SVV and PPV with placement of a radial arterial catheter connected to the ProAQT® System.
* Block duration \> 2 hours.

Exclusion Criteria:

* open surgery
* history of supra ventricular arrhythmias
* beta-blocking patient
* BMI\>30 kg.m-2 or \<15 kg.min-2
* right ventricular dysfunction
* severe valvulopathies
* intracardiac shunt
* renal failure dialysis
* patient's refusal
TREATment of Lower Respiratory Tract Infection in Selected Hospitals in Southern Sri Lanka (TREAT-SL)

This is a stepped-wedge, cluster-randomized, two-arm, open-label, clinical trial of an electronic clinical decision support tool (eCDST) for the diagnosis and treatment of lower respiratory tract infection (LRTI) among patients at three sites in Southern Province, Sri Lanka.

The primary objective of this trial is to determine the impact of an electronic clinical decision support tool (eCDST) on clinical outcomes and antibacterial prescription in subjects with LRTI in the intervention group compared to the control group.

The study will enroll 765 patients ≥ 14 years of age. Medical wards will be randomized in clusters to the intervention at intervals of 3-6 months until all clusters cross over. Participants will be followed for 30 days from enrollment to record clinical outcomes and any antimicrobials prescribed (a maximum of 14 days).


Eligibility Criteria:
Inclusion Criteria:

1. Admitted within prior 48 hours
2. Have evidence of new acute respiratory illness (\<14 days of symptoms), as indicated by at least one of the following:

   1. New cough or sputum production
   2. Chest pain
   3. Dyspnea or tachypnea (respiratory rate \>20 breaths/minute)
   4. Abnormal lung examination
3. Have evidence of acute infection, as indicated by at least one of the following:

   1. Self-reported fever or chills
   2. Documented fever ≥38 ̊ C (100.4 ̊ F)
   3. Documented hypothermia \<35.5 ̊ C (95.9 ̊ F)
   4. Leukocytosis (white blood cell count \>10,000/mm3)
   5. Leukopenia (white blood cell count \<3000/mm3)
   6. New altered mental status
4. Ability and willingness of patient, parent or legally authorized representative (LAR) to give informed consent
5. Ability of children 14-17 years of age to provide assent
6. Ability to complete follow-up encounter at 30 days in person or by telephone

Exclusion Criteria:

1. Hospitalized recently (within last 28 days)
2. If they have been enrolled into this clinical trial previously
3. Surgery in the past 7 days
4. If they are unable or unwilling to complete the follow-up encounter
5. If they will likely be transferred from the medical wards within 24 hours of enrollment (to another ward or to another hospital)
6. If they have underlying conditions or circumstances for which physicians would be unlikely to withhold antibacterials:

   1. Vasopressor therapy
   2. Cystic fibrosis
   3. Known severe immunosuppression (i. Cancer or another condition with neutropenia (absolute neutrophil count \<1000/ microL; ii. Solid- organ or hematopoietic stem-cell transplant within the previous 90 days; iii. Active graft-versus-host disease or bronchiolitis obliterans; iv. On chronic steroids equivalent to prednisone 20mg daily for ≥ 2 weeks or other targeted cytotoxic or biologic immunosuppressants within the prior 4 weeks; v. Human immunodeficiency virus infection with a CD4 cell count \<200/mm3)
   4. Have an accompanying non-respiratory infection
   5. Have evidence of a lung abscess or empyema
   6. Have respiratory failure at enrollment, evidenced by use of non-invasive or invasive ventilation
Community-based Adolescent Diabetes Prevention Program

The number of youth with type 2 diabetes is predicted to quadruple by 2050, with a disproportionate increase among minority youth. The research proposed in this Career Development Award will use community-based participatory research methodology as well as novel strategies (peer education and mobile health technologies) to design, implement and evaluate a diabetes prevention intervention for at-risk ethnic minority youth in an urban community with high disease burden.

Approach: The proposed research addresses diabetes risk and prevention among racial/ethnic minority adolescents in East Harlem (EH), NY. Aim 1 will use qualitative methods to explore the best strategies for using peer education for diabetes risk reduction in youth and the potential role of mobile health technologies in improving adherence to behavioral modification plans. Aim 2 will utilize findings from preliminary studies and Aim 1 to design and evaluate a pilot community-based intervention to 1) maintain/reduce BMI (primary outcome), 2) improve adolescent dietary, physical activity and weight control behaviors, and 3) improve other measures of diabetes risk. Data will be collected at baseline, immediately after the intervention (3 months) and at one year in the intervention and wait list control groups. Aim 3 involves refining the pilot intervention based on an examination of intervention feasibility, acceptability, and sustainability and planning for a future R01.

Eligibility Criteria:
Inclusion Criteria for pre-diabetes screening:

* Adolescents ages 13-19 years of age
* English speaking
* Residents of East Harlem or members of an East Harlem Institution. Membership in an East Harlem institution includes the following:

  1. attending a school in East Harlem
  2. attending an after school or recreational activity in East Harlem
  3. receiving health care in East Harlem Proof of address or membership in an East Harlem institution will not be asked.
* At risk for diabetes (overweight/obese based on measured BMI percentile and with either a parent or grandparent with type 2 diabetes)
* No plans to relocate from New York City in the next year

Note: additional inclusion criteria for participation in workshops include diagnosis of pre-diabetes based on oral glucose tolerance test

Exclusion Criteria for pre-diabetes screening:

* \<13 or \>19 years of age
* Previous diagnosis of diabetes
* BMI percentile \<85th percentile for age and gender based on Centers for Disease Control and Prevention definition
* Currently pregnant
* Speaking a language other than English
* On medications that may raise or lower blood sugar
* Plans to relocate from New York City within one year of enrollment-

Note: additional exclusion criteria for participation in workshops include fingerstick glucoses outside the pre-diabetes range during oral glucose tolerance testing and any cognitive or physical impairment that would preclude comprehension of the group educational program
Safety and Tolerability of Kiddi® Pharmaton Fizz Effervescent Tablets in Children

Study to evaluate the tolerability and safety of Kiddi® Pharmaton Fizz effervescent tablets, in children of 6 to 14 years, comparing a given formula with an improved one with reduced mineral content (qualitatively equivalent to the first one) and a comparator product.


Eligibility Criteria:
Inclusion Criteria:

* Children of both sexes aged between 6 and 14 years, inclusive
* Children, healthy or during convalescence, for which prevention or treatment of marginal vitamin deficits is indicated
* Willingness of the children and parents to give their written informed consent, according to Good Clinical Practice and local regulations
* Pregnant children will not be excluded

Exclusion Criteria:

* Has taken medications containing vitamins A or D, retinoids, or iron during the 4 weeks preceding the study enrolment
* Pre-treatment (less than 2 weeks prior the inclusion in this trial) and/or concomitant treatment with any drug that may influence the trial symptomatology, and may interfere with the evaluation of the safety of the test drug
* Participation in other clinical trials within the last 4 weeks and concurrent participation in another clinical trial
* Relevant allergy or kown hypersensitivity to one of the ingredients of the investigational drug
* Has any serious disorder that may interfere with the participation to the trial
* Malabsorption syndrome, liver and/or renal diseases or juvenile diabetes
* Increased calcium blood concentration, or an increased calcium-excretion
* Evident states of protein deficiency
* Presence of lysinemia (defect of the enzyme lysine ketoglutarate reductase)
Bone Marrow Transplant Chart Review for RIC

We will evaluate the records of 30 patients that have undergone allogeneic transplant, specifically looking at engraftment rate, relapse rate, disease free survival, overall survival, causes of death and other pertinent statistics. We will compare the outcomes to appropriate historical controls.

Primary myelofibrosis (PMF) is among the Philadelphia Chromosome Negative Myeloproliferative Disorders. This diagnosis can be present at a patient's initial diagnosis or it can arise out of preceding Polycythemia Vera or Essential Thrombocythemia. While the clinical course is variable, it is defined by varying degrees of splenomegaly, anemia, fatigue and other constitutional symptoms. Patients with PMF are at increased risk of acute leukemia, bone marrow failure and thrombosis. Currently, the only curative treatment for PMF is allogeneic stem cell transplant. However, as the median age at diagnosis is in the mid to late 60s, most patients are no longer candidates for transplant due to their age and/or other comorbid illnesses.

Unfortunately, all other treatments for PMF are palliative in nature and often of limited efficacy. Over the last several years, many advances have occurred that have increased the safety and improved the outcomes of allogeneic transplants. Perhaps most important has been the ongoing refinement of reduced intensity conditioning (RIC) regimens prior to transplant. Over the last few years, many groups have published data suggesting that these RIC transplants can be very effective in the treatment of PMF and it is felt to be a potentially curative procedure. However, the vast majority of these data are reported in persons younger than 65 years old. The current protocol for RIC transplant for PMF available at the University of Utah excludes patients older than the age of 65.

We would like to see if there is sufficient successful experience with transplant in persons older than 60 years old (including many older than 65 years of age) to justify the creation of a clinical trial using RIC regimens in this older age group. We will be reviewing the medical records of approximately 30 patients at four different institutions:

* University of Utah/Huntsman Cancer Hospital
* Fred Hutchinson Cancer Research Center
* Baylor College of Medicine
* M.D. Anderson Cancer Centers

We will evaluate: engraftment rate, relapse rate, disease free survival, overall survival, causes of death and other pertinent statistics. We will compare the outcomes to appropriate historical controls. We hypothesize that RIC regimens may be justifiably safe in older patients with PMF and hope that our data will allow the development of a corollary clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* \> 60 years of age
* Diagnosed with Primary Myelofibrosis
* Undergone Allogeneic Transplant

Exclusion Criteria:

* Any subjects not meeting the criteria above
Multi-center Study on Pediatric Functional Gastrointestinal Disorders in Mainland China

This study plans to understand the prevalence and clinical characteristics of pediatric functional gastrointestinal disorders in mainland China through multi-center investigation and clinical epidemiological analysis, to reveal the prevalence characteristics and related factors of functional gastrointestinal disorders in children of all ages in mainland China, to establish a diagnostic standard system for pediatric functional gastrointestinal disorders in mainland China, to provide evidence-based basis for the formulation of new Roman standard for functional gastrointestinal disorders, and to provide new ideas and treatment basis for the diagnosis and treatment of functional gastrointestinal disorders in children.

Functional gastrointestinal disorders (FGIDs), also known as brain-intestinal interaction abnormalities, are associated with dynamic disorders, high visceral sensitivity, changes in mucosal and immune functions, changes in intestinal flora, and abnormal central nervous system regulatory functions. FGIDs are the most common causes of diagnosis and treatment of gastrointestinal diseases in children. During the past 10 years, new progress has been made in the study of various FGIDs in children of different ages. FGIDs Rome Commission of Experts revised the relevant diagnostic criteria and officially published the Rome IV criteria for pediatric FGIDs in Gastroenterology in 2016. Due to many factors, the epidemiological survey data of pediatric FGID are still lacking in China. Whether Rome II, Rome III or Rome IV, their diagnostic criteria and epidemiological data were from other countries and regions, so their suitability for China's children remains to be verified. This study plans to understand the prevalence and clinical characteristics of pediatric functional gastrointestinal disorders in mainland China through multi-center investigation and clinical epidemiological analysis, to reveal the prevalence characteristics and related factors of functional gastrointestinal disorders in children of all ages in mainland China, to establish a diagnostic standard system for pediatric functional gastrointestinal disorders in mainland China, to provide evidence-based basis for the formulation of new Roman standard for functional gastrointestinal disorders, and to provide new ideas and treatment basis for the diagnosis and treatment of pediatric functional gastrointestinal disorders.

Eligibility Criteria:
Inclusion Criteria:

* Children diagnosed with functional gastrointestinal disorders

Exclusion Criteria:

* Children not diagnosed with functional gastrointestinal disorders
Phase 1 Study to Compare the Safety, Pharmacokinetic Profiles of CJ-30056 and Lipitor 20mg/Glucophage SR 750mg

This study is designed to evaluate safety and pharmacokinetic properties of the two treatments, the administration of CJ-30056 and the co-administration of atorvastatin 20mg and metformin SR 750mg, in healthy volunteers.

To evaluate the bioequivalence of of CJ-30056 and co-administration of atorvastatin 20mg and metformin SR 750mg

Eligibility Criteria:
Inclusion Criteria:

1. Willing to adhere to protocol requirements and sign a informed consent form
2. Male volunteers in the age between 19 and 55 years old and have the weight range is not exceed ±20% of ideal weight
3. Subjects with no history of any significant chronic disease
4. Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data

Exclusion Criteria:

1. Use of barbital inducer or inhibitor medication within the 28 days before dosing
2. Symptom of an acute illness within 28 days prior to drug administration
3. History of clinically significant hepatic, renal, gastrointestinal diseases which might significantly interfere with ADME
4. History of surgery except or gastrointestinal diseases which might significantly change absorption of medicines
5. History of clinically significant allergies including drug allergies
6. History of clinically significant allergies about atorvastatin or metformin
7. Subjects who have ever or have plan to do intravenous injection of contrast medium (intravenous urography, intravenous cholangiography, computed tomography using contrast medium) within 28 days prior to drug administration
8. History of myopathy
9. Subjects who have genetic problems (galactose intolerance, Lapp lactase deficiency, glucose-galactase malabsorption etc.)
10. Clinical laboratory test values are outside the accepted normal range

    * AST or ALT \>1.25 times to normal range
    * Total bilirubin \>1.5 times to normal range
    * e-GFR \<90 mL/min
11. History of drug, caffein(caffein \> 400mg/day), smoking (cigarette \> 10/day) or alcohol abuse(alcohol \> 30 g/day)or Subjects who have ever drink within 7 days prior to drug administration
12. Special diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice) within 7 days prior to drug administration
13. Donated blood within 60 days prior to dosing
14. Participated in a previous clinical trial within 60 days prior to dosing
15. Use of any other medication, including herbal products, within 10 days before dosing
16. Subjects considered as unsuitable based on medical judgement by investigators
Effect of Polyphenol-rich Dark Chocolate on Obesity

This study aims to investigate the effect of polyphenol-rich dark chocolate (DC) on insulin resistance, adiponectin , blood pressure (BP), lipid profile in obese subjects and determine possible associations between all assessed parameters.

It hypothesizes that consumption of polyphenol-rich Dc could lower fasting glucose levels, insulin resistance and improve BP, total cholesterol, low-density lipoprotein (LDL) and triglycerides while increasing adiponectin and high-density lipoprotein (HDL) in overweight or obese individuals.

It is well acknowledged that the main mechanism by which cocoa and DC polyphenols improve fasting glucose levels, insulin sensitivity, BP and lipid profile in healthy individuals and those with hypertension and/or impaired glucose-tolerance, involves increased nitric oxide (NO) bioavailability. NO is essential for the regulation of blood pressure, glucose and lipid balance. This is evident in that e-NOsynthase knockout mice exhibit insulin resistance, hypertension and hyperlipidemia, a cluster of diseases that is also observed in the metabolic syndrome. Recently, it was shown that adiponectin regulates eNOsynthase activity through the phosphatidylinositol 3-kinase-dependent pathway wherein eNOsynthase is phosphorylated by 5'-AMP-activated protein kinase at Ser1179 and that plasma adiponectin levels are inversely correlated with BMI, waist-to-hip ratio, fasting plasma glucose, insulin, triglyceride, hyperinsulinemia, and glucose intolerance and positively with HDL-cholesterol, but not BP. This suggests a strong link between impaired NO bioavailability, adiponectin levels and obesity. Indeed, apart from exhibiting impaired NO bioavailability, obese individuals also have decreased plasma adiponectin levels. Since cocoa and DC are known to modulate NO activity, investigating the impact of cocoa or DC polyphenols on adiponectin levels and observing a correlation between its levels and improved fasting glucose levels, insulin resistance, BP and lipid profile is essential in improving our understanding of the relationship between diet and health, particularly that polyphenols in apples, oolong and green tea polyphenols have been previously shown to influence adiponectin levels.

This study uses a randomised single-blind, placebo-controlled design. Following a 1-week run-in phase, each group will be randomised to one of the two groups: placebo-polyphenol-rich DC, polyphenol-rich DC-placebo. Subjects will follow each diet for 4weeks, after which they will cross-over to the next diet separated by a 2-week washout period and until each subject completes both interventions.

Eligibility Criteria:
Inclusion Criteria:

* Healthy female volunteers
* Aged 18-50 years
* Group 1 will consist of volunteers with BMI of 18-25 kg/m2
* Group 2 will consist of women with BMI of 25-35 kg/m2

Exclusion Criteria:

* Cardiovascular disease
* Hypertension
* Diabetes
* Smokers
* People taking dietary supplements
* Hypertension or cholesterol-lowering drugs
* Those with high cocoa or DC intake, soy or nut allergies