cyrilzakka/clinical-trials huggingface dataset:
Clinical Experiment of Helicobacter Pylori Transmission

The study proposes to test whether chronic infection with Helicobacter pylori protects individuals from symptomatic infection with enteropathogenic E. coli. The study will also evaluate the effect of gastric acidity in this relationship.

Because H. pylori is an enteric infection, its prevalence may be linked to exposure to other enteric pathogens. Results of observational studies on the association between H. pylori and gastroenteritis, however, have been conflicting. Some have shown increased incidence of diarrhea in children with H. pylori infection, with one study attributing 11% of diarrhea cases to H. pylori. Other studies found no association, and still others found a protective effect of H. pylori against gastroenteritis. Dissecting out confounding from true physiological associations can be difficult in observational studies. To better elucidate the association between H. pylori and gastroenteritis, we performed a direct challenge experiment with a well-characterized gastrointestinal pathogen, enteropathogenic Escherichia coli (EPEC). EPEC is a leading cause of infantile gastroenteritis in the world and has a long history of safe use in human experiments. It is also acid sensitive: in our laboratory less than 0.001% of inoculated EPEC organisms survived at pH 2.5. Our goal was to test the hypothesis that chronic infection with H. pylori increases the risk of diarrheal illness after direct challenge with EPEC.

Eligibility Criteria:
Inclusion Criteria:Healthy Exclusion Criteria:prior gastrointestinal disease prior treatment of H. pylori infection immune suppression or deficiency history of cancer, diabetes, or other co-morbidity
Transdermal (TDS) Oxybutynin (Oxytrol(r)) in Overactive Bladder

This study evaluates changes in health related quality of life outcomes in patients using Oxytrol(r)


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with one or more symptom of overactive bladder, including urge urinary incontinence, urgency and/or frequency

Exclusion Criteria:

* Patients for whom Oxytrol(r) is contraindicated.
* Patients treated with Oxytrol(r) prior to participation in this study.
* Patients residing in long-term care facilities or nursing homes.
A Clinical Study to Determine if Beta Glucan Reduces the Incidence, Duration or Severity of URTIs Among Skiers

This study is designed to determine if a dieatary supplement containing beta-glucan can reduce the incidence, severity and duration of upper respiratory tract infections among a group of highly trained athletes

In this study, we hypothesize that consumption of 200 mg beta-glucan per day will lessen the frequency, duration and severity of URTI symptoms in a population of elite, internationally competitive skiers over a 45-day period. In order to complete this objective, we will utilize the Wisconsin Upper Respiratory Symptom Survey-24 (WURSS-24) to monitor and quantify the incidence, duration and severity of URTI symptoms. A secondary objective is to determine if beta-glucan supplementation reduces or mitigates early indictors of athlete-specific stress. This objective will be assessed using the Athlete Psychological Strain Questionnaire (APSQ), a 10-question patient-reported outcome tool used to evaluate athlete-specific psychological stress.

This will be a randomized, double blind, placebo controlled, parallel arm design conducted over a 6-week period. 50-60 healthy subjects will be recruited and randomized in a 1:1 ratio to either of two interventions:

1. Placebo: daily consumption of the placebo tablet
2. Treatment: daily consumption of the supplement (treatment) tablet

In addition, subjects will complete the WURSS-24 survey daily, and the APSQ survey weekly.

Eligibility Criteria:
Inclusion Criteria:

* Provide informed consent by signing the electronic Information and Consent Form.
* Male or females between the ages of 18 and 30 (inclusive) without regard to race or ethnic background
* Are in generally good health and have no medical conditions that would prevent or interfere with their participation in the study
* Are fully able and willing to comply with the requirements of the study
* Are fully able and willing to keep scheduled appointments

Exclusion Criteria:

* Females that are pregnant, attempting to become pregnant or are currently lactating/nursing a child.
* Individuals currently taking prescription medications that are known to be immunosuppressants (e.g. dexamethasone, tacrolimus, methotrexate)
* Individuals with gastrointestinal conditions (e.g., inflammatory bowel disease, Crohn's disease, etc.) that may affect consumption of the treatment supplements.
* Individuals with clinically important renal, hepatic, cardiac pulmonary, pancreatic, neurologic or biliary disorders; insulin-dependent and orally controlled diabetics will also be excluded from the study.
* Individuals with a recent history of cancer other than non-melanoma skin cancer.
* Individual's that have trouble swallowing pills.
* Individuals that have participated as a subject in any other clinical study within 30 days of screening.
* Individuals with a history of alcohol abuse or other substance abuse within the previous 2 years.
* Individuals that currently use tobacco products including chewing tobacco and cigarettes.
Cardiopulmonary Exercise Testing in Interstitial Lung Disease

In patients with Interstitial lung diseases (ILD) dyspnea is the most often symptom. Pulmonary lung function tests often do not Show the dyspnea. Aim of the study is to evaluate cardiopulmonary exercise testing concerning therapeutic Monitoring in ILD.


Eligibility Criteria:
Inclusion Criteria:

* informed consent provided
* ILD

Exclusion Criteria:

* no informed consent
* no ILD
Study of Palifosfamide-tris in Combination With Doxorubicin in Patients With Front-line Metastatic Soft Tissue Sarcoma

This is an international, randomized, double-blind, placebo-controlled trial to evaluate the clinical efficacy of palifosfamide-tris administered with doxorubicin in combination, compared with doxorubicin administered with placebo in front-line patients diagnosed with metastatic soft tissue sarcoma (STS).


Eligibility Criteria:
To be eligible, each patient must meet EACH of the following criteria:

* Age ≥18 years.
* Documented soft tissue sarcoma
* Metastatic disease for which the patient has not received any prior treatment, and for whom treatment with doxorubicin is considered medically acceptable.
* ECOG Performance Status of 0, 1 or 2
* Adequate bone marrow and organ function based on the results of protocol- specified laboratory tests
* Male and female patients must agree to use a highly reliable method of birth control during study participation.
* Able to provide informed consent

To be eligible, each patient must meet NONE of the following criteria:

* Specific sarcoma histological subtypes including GIST and Ewing's sarcoma.
* Systemic therapy for the treatment of metastatic sarcoma, prior to or during the study. However, patients may have received neo-adjuvant/adjuvant Gemzar and Taxotere chemotherapy for their primary sarcoma, prior to the development of metastatic disease
* Any prior anthracycline use.
* Known allergy to any of the study drugs or their excipients.
* Any unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a patient and/or their compliance with the protocol, based on screening tests, physical examination and medical history (as specifically defined in the clinical protocol).
* Myocardial dysfunction defined as left ventricular ejection fraction (LVEF) \<50%.
* Documented metastases to brain or meninges.
* Any malignancy other than sarcoma within the last 5 years prior to screening, with the exception of cervical carcinoma in situ, basal cell carcinoma, or superficial bladder tumors (Ta, Tis, or T1) that have been successfully and curatively treated with no evidence of recurrent or residual disease.
* Currently pregnant or nursing.
* Radiotherapy with curative intent within 4 weeks of first dose of study drug.
Clinical Outcomes About Heparin Surface Modified Aspheric Lens

The purpose of this study is to obverse the effect of this type lens in the same as traditional aspheric intraocular lens at the same time, whether can further improve the effects of operation.

1. Heparin surface treatment lens can reduce inflammatory reaction.
2. Modified aspheric lens are more in line with human optical properties than the traditional aspheric lens.
3. To obverse the effect of this type lens in the same as traditional aspheric intraocular lens at the same time, whether can further improve the effects of operation.
4. After one day, one week, one month, three month follow-up，Key observation on the flare, the optical quality, contrast sensitivity and other parameters.Study the postoperative inflammatory reaction with test group lens，and the impact on the visual quality.

Eligibility Criteria:
Inclusion Criteria:

* Cataract patients

Exclusion Criteria:

* Eyed patients
Test-and-treat for Influenza in Homeless Shelters

This study is a stepped-wedge cluster-randomized trial of on-site rapid testing and treatment for influenza in homeless shelters within the Seattle area to determine whether this strategy reduced the incidence of influenza in the shelter environment.

The study will be conducted over the course of two flu seasons, and all shelters will start with routine surveillance of influenza using mid-turbinate nasal swabs for sample collection and RT-PCR testing. Shelters will be randomized to implement a test-and-treat strategy at different months throughout flu season, treating individuals who present ARI symptoms or new or worsening cough within 2 days (48 hours). Shelters will continue routine surveillance until all offer the test-and-treat strategy. Eligible individuals will be tested on site with a point-of-care molecular influenza test and, if positive, offered antiviral treatment. Individuals with 3-7 days of symptoms, or who choose not to participate in the intervention strategy, will still be eligible for participation in the routine surveillance.

Our primary hypothesis is that implementation of a point-of-care diagnostic and antiviral treatment intervention among sheltered individuals experiencing homelessness will reduce the incidence of influenza within this population over the course of a flu season. A process evaluation will also be conducted to explore the feasibility of point-of-care testing implementation in this population.

Eligibility Criteria:
Inclusion Criteria:

* Resident for 1 or more days at a participating shelter
* ≥2 ARI symptoms or acute cough alone
* Willing to take study medication
* Willing to comply with all study procedures, including weekly surveillance and repeat nasal swab at day 2/3 and day 5/6/7 post-treatment
* Able to provide written, informed consent and/or assent

Exclusion Criteria:

* Any serious or uncontrolled medical disorder or active infection that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration
* Inability to consent and/or comply with study protocol
* Individuals who have received oseltamivir or baloxavir within past 7 days for treatment of influenza
* Individuals with known hypersensitivity to baloxavir marboxil or oseltamivir
* Individuals with chronic kidney disease
Implementation Study of the PostOperative Nausea and Vomiting Prediction Rule

This study evaluates whether the implementation of a prediction rule for postoperative nausea and vomiting changes physician behaviour, improves patient outcome and improves cost-effectiveness of treatment of postoperative nausea and vomiting.

Background and objectives. So-called prediction rules (risk scores) have become increasingly popular in all medical disciplines. This will only rise with the introduction of electronic patient records as these will enhance their use. However, effects of implementation of such rules in daily care has hardly been studied. Also not in anesthesiology. We developed and validated an accurate rule to preoperatively predict the risk of postoperative nausea and vomiting (PONV) in surgical inpatients. PONV causes extreme patient discomfort and occurs in even 30%-50% of all surgical inpatients. As routine administration of PONV prophylaxis is not cost-effective, a risk-tailored approach using an accurate prediction rule is widely advocated. Before large-scale implementation, we aim to study whether such implementation indeed changes physician behavior and improves patient outcome. Given the increase interest in prediction rules, another aim is to study general causes of successful/poor implementation of prediction rules in health care. Design. Cluster, randomized study in which 60 anesthesiologists and senior residents of the UMC Utrecht will be randomized to either the intervention or usual care group.

Study population. Adult,elective,non-ambulatory,surgical patients undergoing general anesthesia of UMC Utrecht.

Intervention. Implementation of risk-tailored PONV strategy (use of the PONV prediction rule with suggested anti-emetic strategies per risk group) in current care.

Outcomes. Primary:incidence of PONV in first 24 hours. Secondary:change in anesthesiologists' behavior in terms of administered anti-emetic management, cost-effectiveness of intervention, attitudes of physicians towards prediction rules in general.

Sample size. 11,000

Economic evaluation. Estimation of incremental costs per prevented PONV case.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Undergoing elective surgery
* General anesthesia

Exclusion Criteria:

* emergency surgery
* postoperative transfer to ICU
Initiative for Patient Outcomes in Dialysis - Peritoneal Dialysis (PD) (IPOD-PD Study)

The aim of the study is to asses the hydration status of incident peritoneal dialysis (PD) patients and its evolution over a period of four years, independent of the PD treatment modality (APD or CAPD) and the PD solution type.

Achieving optimal fluid balance remains a major clinical challenge in peritoneal dialysis (PD) patients. With the recent development of a new bioimpedance spectroscopy (BIS) device, the BCM-Body Composition Monitor (BCM), it is now possible to quantify deviations of hydration status and to define target weight directly.

It has been observed that more than 50% of the PD patients are overhydrated, as compared to the healthy population. This overhydration seems to be associated with modifiable practice-related factors, such as correct PD prescription according to membrane transport status, and dietary fluid intake.

The aim of this study is to assess the hydration status of incident PD patients, and diagnose the underlying reasons for incorrect fluid status. In addition, changes in fluid status, residual renal function and nutritional status, over a follow-up period of up to four years will be registered.

The investigators assume that the use of the BCM-Body Composition Monitor (BCM) provides quantitative measurement of hydration status and thereby supports physicians in identifying patients who are not euvolaemic. Hence, the BCM allows an improved management of underlying causes of non-euvolaemic hydration state and appropriate monitoring of fluid status.

Eligibility Criteria:
Inclusion Criteria:

* Incident patients directly before start of peritoneal dialysis
* Patients in whom routine measurement of body composition monitoring is performed

Exclusion Criteria:

* Patients treated with HD before start of PD
* Patients in whom body composition monitoring cannot be performed
Metabolism in the Human Brain Following Consumption of a Keto-ester in Alcohol Use Disorder (AUD) With Proton Magnetic Resonance Spectroscopic Imaging (MRSI)

The objective of this study is to determine whether BHB levels in the brain will be positively associated with alcohol consumption, due to hypothesized enhancement of BHB transport into the brain.

The primary objective of this study is to determine whether BHB levels in the brain will be positively associated with alcohol consumption, due to hypothesized enhancement of BHB transport into the brain. Furthermore, BHB levels in identified brain regions will be compared against measures of craving.

The secondary objective of this study is to investigate if GABA levels will be elevated in key brain regions relative to the baseline scan in AC subjects due to preferential BHB metabolism. The goal is to acquire preliminary data to apply for an R01 or equivalent grant submission to pursue this metabolic therapy in greater detail using the state-of-the-art MRSI platform at Yale University to study alcohol use disorders.

Eligibility Criteria:
Inclusion Criteria:

* For AUD patients: individuals assessed to be with mild to - medium severity according to the DSM-5 criteria.
* For non-dependent heavy at-risk drinkers: must be Individuals who consume more than 14 drinks per week for men or more than 8 drinks per week for women, for at least the last 2 months.
* For healthy controls: must be light drinkers not dependent on alcohol, who consume fewer than 2 drinks per week for at least the last 6 months.
* English speaking
* Can read and understand a study the consent form

Exclusion Criteria:

* Non-English speaking
* Unable to read and understand the consent form
* History of alcohol withdrawal in the last 12 months. This will reduce chances of a volunteer having withdrawal symptoms in the middle of the experiment.
* Participants with a history of psychiatric conditions (that include PTSD, schizophrenia, and bipolar disorders), or a history of neurological conditions
* Women who test positive on a pregnancy test collected on either the screening visit or day of the study.
* Healthy subjects identified with substance use with the exception of tobacco and alcohol will be excluded.
* AC subjects identified with substance use, with the exception of tobacco, alcohol, and mild cannabis use disorder (based on the DSM-5 criteria during the medical history) in the last 6 months, will be excluded.
* Persons unable to refrain from alcohol use for 48 hours and undergo a 10-hour fast prior to the study
Observational Study to Evaluate the Actual Use and Effectiveness of Dymista® Nasal Spray in Asian Patients

Gathering knowledge on the use of Dymista® in Asian patients who receive Dymista® for the first time in routine clinical practice

A) Primary objective:

Gathering knowledge on the use of Dymista® in Asian patients who receive Dymista® for the first time in routine clinical practice; Patient's demographic;

Anamnestic background including:

* allergic and other comorbidities
* allergic conjunctivitis
* polysensitization
* current symptoms
* previous treatments of allergic rhinitis
* usage of current asthma reliever medication
* family history of allergy

B) Secondary Objective:

* Response to therapy with Dymista® nasal spray in routine clinical practice.
* Quality of sleep (by VAS)
* Troublesomeness in daily activities (by VAS)
* Patient's assessment about the regular use of Dymista®
* Patients opinion about continuation of Dymista® treatment after end of the observational period

Eligibility Criteria:
Inclusion Criteria:

* The first prescription of Dymista® nasal spray according to the summary of product characteristics (SPC) and patient information leaflet and independently from the patient's enrollment in the study.
* Patients with moderate to severe seasonal or perennial allergic rhinitis
* For Hong Kong and Malaysia: Adult and children of age ≥ 12 years
* For Taiwan: Adult and children of age ≥ 6 years.
* For Thailand: Adults and children of age ≥ 12 years with seasonal and/or perennial allergic rhinitis OR children of age 6-11 years with only seasonal allergic rhinitis
* Acute allergic rhinitis symptoms at the day of inclusion (i.e. VAS-Score ≥50 mm)
* Signed informed consent/assent from the patient and, if applicable, the parent(s) or legal guardian(s) in compliance with local requirements.
* Ability to understand and follow the instructions for using Dymista® nasal spray according to the patient information leaflet.
* Willingness to complete and return the Patient Card.

Exclusion Criteria:

* VAS score \<50 mm on day of inclusion
* Known allergic reaction from and/or intolerance to Dymista® nasal spray or any of the ingredients.
* Pregnancy/planned pregnancy or breastfeeding during this NIS
* Patients or parent(s)/legal guardians (as applicable) not able to fulfill study requirements according to the Investigator's opinion.
Physio PCI: Impact of Coronary Angioplasty on Non-hyperaemic Pressure Ratio in Patients With Coronary Artery Disease

The use of intra coronary physiological assessment with fractional flow reserve (FFR) is nowadays the standard approach to define ischemia-inducing stenosis and guide myocardial revascularization strategy in patients with coronary artery disease. Further, FFR has been shown to be a strong and independent predictor of major adverse cardiac events after stent implantation. A lower value of FFR after stent implantation is associated with a worse clinical prognosis, without a clearly defined threshold above which clinical follow up are similar for all FFR values. Among 750 patients in the Fractional Flow Reserve Post-Stent Registry, the event rate was 29.5% in patients with FFR\<0.80 compared to 9 4.9% in patients with FFR\>0.95 (p\<0.001). However, FFR remains poorly adopted in many cathlabs, partly because of procedural time, discomfort or sides effect during hyperemia, non-uniform adenosine response and economical constraints. This leads to the validation of resting indices (instantaneous wave-free ratio (iFR), diastolic pressure ratio (dPR), and resting full-cycle ratio (RFR) among others). Those indices evaluate coronary physiology without the use of maximal hyperemia and have 15 slightly different threshold compared to FFR (≤0.89 vs 0.80, for iFR and RFR, and FFR 16 respectively).In the VALIDATE RFR study, a head-to-head comparison of RFR and iFR from a retrospective analysis, diagnostic accuracy of RFR was 97.4% with an area under the curve 1 (AUC) of 99.6%. In the more recent RE-VALIDATE RFR study, 431 patients with 501 lesions 2 were prospectively evaluated for the diagnostic performance of RFR in all-comers patients. Compared to iFR, RFR achieved high diagnostic accuracy, sensitivity and specificity. These are the reasons why we designed a prospective, non-randomized, clinical trial, to better 18 explore the value of RFR before and after PCI in real live and after optimization by post dilation 19 in all-comers patients with coronary artery disease in the Middle East region..


Eligibility Criteria:
Inclusion Criteria:

* Patient is ≥ 21 years
* The patient is deemed eligible for PCI of at least one coronary stenosis (RFRpre ≤0.89 or FFR≤0.80)
* The patient is able and is willing to comply with all study procedures and process.

Exclusion Criteria:

* The patient is in cardiogenic shock
* The patient has a bifurcation lesion that requires a planned two stents technique
* The patient refuses to participate.
* The patient suffers acute coronary syndrome and should be treated by PCI in the culprit lesion (non-culprit lesions in non-culprit vessel could be included)
* The patient has an ostial stenosis to be treated by PCI
Staccato Loxapine Pulmonary Safety in Patients With Asthma

The purpose of this study is to assess the safety of 2 inhaled doses of Staccato Loxapine within a day in patients with asthma.


Eligibility Criteria:
Inclusion Criteria:

* History of mild to moderate persistent asthma for at least 6 months with pre-bronchodilator FEV1 ≥60% of predicted value.

Exclusion Criteria:

* History of COPD, or any other acute or chronic pulmonary disease