cyrilzakka/clinical-trials huggingface dataset:
Systemic Corticosteroids in the Perioperative Management of Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)

Oral corticosteroids are commonly utilized for the management of chronic rhinosinusitis with and without nasal polyps (CRSwNP and CRSsNP, respectively). Although strong evidence supports the benefit of routine and perioperative oral corticosteroids for CRSwNP, there is limited evidence to support their utility for CRSsNP. The investigators intend to perform a randomized, double blind, placebo controlled clinical trial to investigate the impact of steroids used within 2 weeks prior to surgery for CRSsNP. Patients with CRSsNP that present to the investigators office will be included if they have failed maximal medical management and have elected to undergo endoscopic sinus surgery (ESS) after July 1, 2014. The investigators hypothesis is that oral corticosteroids given 2 weeks prior to surgery will improve subjective and objective outcome measures.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (ages 18-80) with a diagnosis of chronic rhinosinusitis without nasal polyps (CRSsNP) that have failed a 6 week trial of maximal medical therapy and have elected to undergo endoscopic sinus surgery will be offered enrollment in this study.
* Diagnosis of chronic rhinosinusitis (CRS) is based on the European Position on Rhinosinusitis (EPOS) 2012 guidelines.
* These include a greater than 12 week history of inflammation of the nose or paranasal sinuses characterized by at least 2 symptoms.
* These symptoms must include at least one of the following:

  * nasal obstruction
  * rhinorrhea
  * postnasal drip.
* Additional symptoms can include facial pain/pressure or anosmia/hyposmia.
* These symptoms must be supplemented by either endoscopic signs of disease or characteristic CT changes.
* The presence or absence of nasal polyps defines the subtype (with polyps: CRSwNP; without polyps: CRSsNP).

Exclusion Criteria:

* Patients will be excluded if they have nasal polyps or suspected allergic fungal rhinosinusitis (AFRS) based on classic endoscopy and CT findings.
* Additionally, patients with known immunocompromise or mucociliary disorders will be excluded.
* Patients that received oral corticosteroids within 6 weeks prior to the planned surgery will also be excluded.
BAFF and APRIL and RESPONSE TO BELIMUMAB in SLE

This project is intended to identify the routes on which BAFF and APRIL act in order to detect possible future candidates to Belimumab treatment among patients diagnosed of SLE.

DESIGN Establish the influence of certain polymorphisms in the levels of expression of different transcripts and proteins.

Quantify the levels of B cell activating factor belonging to the TNF family (BAFF) and a proliferation-inducing ligand (APRIL) in serum and urine of patients and controls by Enzyme-Linked Immunosorbent Assay (ELISA). BAFF Determine the expression levels of different BAFF and APRIL transcripts in peripheral blood mononuclear cells from patients and controls using a digital PCR (polymerase chain reaction) system.

Compare distribution of gene polymorphisms in BAFF and APRIL in patients and controls. by sequencing the exome of the ligand and receptor genes using next generation sequencing (NGS).

Correlate the transcript and protein levels with clinical manifestations and disease activity.

The results of the quantification of anti- double-stranded deoxyribonucleic acid.(dsDNA) antibody levels tests will be recorded together with those demographics, clinical-epidemiological and response to the treatment.data.

Eligibility Criteria:
Inclusion criteria

* Women18-60 years old
* For patients only treated with conventional drugs (without immunosuppressive or biological treatment )
* For Healthy controls: no autoimmune diseases (blood donors) diagnoses
Assess the Safety & Reactogenicity of DTPa-IPV/Hib Vaccine Administered at 3, 4, 5 & 18 Mths of Age, in Healthy Infants

To assess the safety and reactogenicity of the DTPa-IPV/Hib vaccine as primary and booster vaccination. The DTPa-IPV/Hib vaccine given at 3 and 4 months of age is co-administered with GSK Biologicals' rotavirus vaccine or Placebo.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Single group study. Subjects in GSK Biologicals' rotavirus study (Rota-028) in Singapore will be enrolled in this study. 3-4-5 month schedule with a booster dose at 18 months

Eligibility Criteria:
Inclusion criteria

* Subjects must have been enrolled in the Rota-028 study.
* A male or female between, and including, 11 and 17 weeks of age at the time of the first vaccination.
* Written informed consent obtained from the parent or guardian of the subject.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.
* Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol

Exclusion criteria

* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period.
* Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of the vaccine and ending 30 days after.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
* A family history of congenital or hereditary immunodeficiency.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Major congenital defects or serious chronic illness.
* History of any neurologic disorders or seizures.
* Acute disease at the time of enrolment.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Screening for Chronic Liver Diseases in General Population

Improving the care of patients with liver diseases in primary care and will allow patients with chronic liver disease to benefit from a course appropriate care.

The prevalence of chronic liver diseases continues to increase on the one hand by the increase in non-alcoholic fatty liver disease (NAFLD) which affects 25% of the general population as well as the increased incidence of hepatocellular carcinoma in recent years. Screening for liver fibrosis in the general population represents a major public health issue.

The FIB-4 score is obtained by a blood test. This score combines age, measurement of ALT/ASAT (alanine aminotransferase / aspartate-aminotransferase) and platelet count. This score is sensitive for detecting advanced fibrosis liver and allows 71% of patients to avoid a liver biopsy.

Transient elastometry (Fibroscan®) is another very effective non-invasive assessment in the diagnosis of chronic liver diseases and hepatic fibrosis. It has already been demonstrated by several studies that combining several non-invasive fibrosis tests allows to improve the precision of the result.

The investigators hypothesize that offering an additional assessment by Fibroscan for patients screened by a blood test (FIB-4 Score) as possibly having advanced liver fibrosis (Score \>1.3) will raise awareness among professional practitioners and the general population with chronic liver diseases and refine screening for chronic liver diseases.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 40 years
* Without known liver pathologies
* Having at least one risk factor for chronic liver disease: risky consumption of alcoholic beverages according to the AUDIT questionnaire, the presence of metabolic syndrome, diabetes or a risk factor for viral hepatitis B, D or C.

Exclusion Criteria:

* Fibroscan already performed in the last 12 months
* Failure to collect express oral consent
* Patient not affiliated with or not benefiting from a national health insurance scheme
* Patient protected by law
* Patient under guardianship or curatorship
* Patient deprived of liberty
* Pregnant or breastfeeding woman
Evaluate the Effectiveness of Intravitreal (IVT) Aflibercept Injection in Clinical Practice in naïve Patients With Neovascular Age-related Macular Degeneration (nAMD)

There is a need to investigate the effectiveness of IVT aflibercept injection in routine clinical practice.

The aim of this study is to collect 12-month real-world clinical data from treatment-naïve nAMD patients who started first-line treatment with IVT aflibercept injection, according to the SmPC (Summary of Product Characteristics) and the SERV (Spanish Society of Retina and Vitreous) guidelines. The effectiveness of IVT aflibercept will be assessed by the changes in VA (Visual Acuity) and CRT (Central Retinal Thickness) during treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient aged 50 years or more at aflibercept treatment initiation.
* Treatment-naïve patients with nAMD
* Patients who initated treatment with IVT aflibercept injection between 1st April 2014 to 31st May 2016
* Patients that have been decided to be treated with IVT aflibercept with a minimum treatment follow-up with IVT aflibercept injection of at least 12-months, in accordance with the approved SmPC.
* Patients who have been provided with appropriate information about the study objectives and procedures and who have given their written informed consent.

Exclusion Criteria:

* Patients who have previously been treated with anti-VEGF intravitreal injections, systemic anti-VEGF or pro-VEGF treatments, as well as other intravitreal steroids or steroid implants for the study eye.
* Patients that switched to another treatment alternative different from IVT aflibercept injection during observation period of 12 months
* Patients with another retinal disease: diabetic retinopathy, diabetic macular edema (DME), myopic choroidal neovascularization, retinal vein occlusion (RVO), central serous chorioretinopathy (CSC), angioid streaks.
* Patients with scarring, fibrosis, or atrophy involving the center of the fovea in the study eye at treatment initiation
* Patients with advanced cataract or advanced glaucoma
* Patients with presence of retinal pigment epithelial tears or rips involving the macula in the study eye prior to treatment initiation.
* Patients who do not meet the local Guideline criteria for aflibercept treatment. Contraindications listed in the SmPC must be taken into account.
The Efficacy of Vocal Function Exercises for Laryngeal Cancers

The purpose of this study is to determine if the systematic practice of Vocal Function Exercises (VFE) improves selected measures of voice production in participants who have previously been irradiated for early glottic cancers compared to participants who receive the present standard of care, namely, vocal hygiene counseling. It is hypothesized that a prescriptive vocal exercise program (VFE) will improve the voice production of individuals who have been previously treated for laryngeal cancers when compared to participants who receive vocal hygiene alone.


Eligibility Criteria:
Inclusion Criteria:

* Hearing level and cognitive ability to follow test directions
* Laryngeal cancer
* Radiation Therapy completed \>= 6 months
* Deemed disease free by the treating physician
* Subjects have to be willing to attend weekly voice therapy sessions

Exclusion Criteria:

* Adjuvant treatment: laser or any surgical intervention
* Neurological or cognitive impairment
* Hearing levels that interfere with following test instruction
* Vocal fold paralysis
An Integrated Care Model for Chronic Patients

Integrated care models aim to promote the coordination and communication between services. The present study aim to evaluate the effectiveness of a new integrated care model (Salut+Social model) which will promote the coordination and communication between social and healthcare services in southern Catalonia (Spain) for the improvement of quality of life of chronic patients, adherence to treatment, access to medical services and caregiver overload. Also, we will evaluate the experience of health and social professionals with the new model implemented.

A clinical trial with mixed methodology will be carried out. The intervention consists of the promotion and coordination between the social and health sectors, for 6 months, through the use of information and communication technology (ICT) tools that operate as an interface for the integrated care model. The study subjects are chronic patients with health and social conditions that are susceptible to be treated in a collaborative and coordinated way in the field of primary health care. A sample size of 141 patients was estimated. Questionnaires will be used at baseline and at 6, 9 and 12 months after the beginning of the study for the evaluation of quality of life, treatment adherence, medical service and caregiver overload. The principal variable is the quality of life. For statistical analysis, comparisons of means and proportions at different time points will be performed. One discussion group will be performed with the aim of improving the care model according to professionals' opinions. A thematic content analysis will be carried out.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with at least one health and one social condition, as below specified:

  1. health condition, according to diagnosis of the electronic medical history: complex chronic patient; advanced chronic disease; patient in the home care program; dementia; neurodegenerative diseases; stroke; others chronic disease.
  2. social condition, according to social service workstation from Ribera d'Ebre district: dependence grade; home social service assistance; teleassistance systems assigned by home support.
* Knowledgement of Spanish or Catalan.
* Accepting participation in the study (with informed consent signed by the patient or by the caregiver).

Exclusion Criteria:

* Institutionalized patients.
* Users with difficulties filling out or respond a questionnaire.
NIche Development With Closure of Cesarean Uterotomy by Modified or Conventional Two-layer Technique

The aim of this trial was to compare two different uterotomy surgical techniques on the occurrence of a uterine niche and the risk of a number of short- and long-term gynecological complications associated with the presence and size of the niche.


Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnant
* Intended elective cesarean section

Exclusion Criteria:

* Cervical dilatation of more than 4 cm
* Previous cesarean section
Telephone-Based Re-education for Hp Eradication

It was suggested that the patient compliance plans an important role in the Hp eradication. However, data on whether re-education could improve the eradication rate are lacking. We consider that re-education on patients by telephone during the process of drug administration could increase the eradication rate in Hp infected patients.

We hypothesized that telephone re-education during the whole process of drug administration would improve the compliance of patients and ultimately increase the Hp eradication rate.


Eligibility Criteria:
Inclusion Criteria:

1. Prior informed consent
2. 18-70 years of age
3. Hp infected patients diagnosed by 13C urea breath test, including digestive ulcer, gastritis with dyspepsia symptoms, family history of gastric cancer, planning to use long-term non-steroidal anti-inflammatory drugs (NSAIDs), or personal request
4. Ability to swallow oral medications
5. No contraindication for the drugs used for Hp eradication
6. Both men and women enrolled in this trial must use adequate barrier birth control during the course of the trial and 4 weeks after the completion of trial

Exclusion Criteria:

1. Pregnant or breast-feeding subjects
2. Previous failed treatment of Hp eradication
3. Previous treatment with bismuth salts or antibiotics within 1 month before study enrollment, and treatment with proton pump inhibitor or H2 receptor antagonist within 2 weeks before study enrollment
4. Any disease that could jeopardize the safety of subject and their compliance in the study (e.g. serious liver disease, heart disease, kidney disease, malignant tumor or alcoholism, etc.)
5. Previous upper gastrointestinal surgery
6. Inability to express complaint (e.g. mental disorder, psychoneurosis, unable to cooperation, etc.)
7. Active clinically serious infections, except for Hepatitis B virus and hepatitis C virus infection
8. Clinically significant gastrointestinal bleeding within 4 weeks prior to start of study drug
Study Evaluating Preference, Satisfaction and Ease of Use of Inhalers in Chronic Obstructive Pulmonary Disease (COPD) Diagnosed Patients

Preference study: Genuair vs HandiHaler inhalers in COPD patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult male or female patients aged ≥ 40 with stable COPD
* Naïve patients to the use of study inhalers
* Patients agreeing on participating and signing the Informed Consent Form

Exclusion Criteria:

* Patients with other clinically significant disease, particularly body malformations or diseases affecting coordination and/or motor system
* Patients unable to read product package instructions and answer patient reported questionnaires
Edible Plant Exosome Ability to Prevent Oral Mucositis Associated With Chemoradiation Treatment of Head and Neck Cancer

This study will evaluate the ability of grape exosomes, given to the subject as grape powder, as an important anti-inflammatory agent to reduce the incidence of oral mucositis during radiation and chemotherapy treatment for head and neck tumors.

The purpose of this study is to investigate the ability of plant (grape) exosomes to prevent oral mucositis associated with chemoradiation treatment of head and neck cancer. Also, to be evaluated is the effect of grape exosomes on the production of cytokines and immune responses to tumor exosomal antigens, metabolic and molecular markers in these patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have definitive diagnosis of head and neck cancer.
* Concurrent chemoradiation treatment of the primary tumor must be an option for the newly diagnosed cancer.
* Patients must be informed of the investigational nature of this study and sign and give written informed consent in accordance with institutional and federal guidelines.
* Absence of life limiting medical conditions
* Ability to understand and willingness to sign a written informed consent document.
* ECOG performance status 0, 1, or 2 (Karnofsky \> 60%).
* Patients must have adequate bone marrow function. ANC \> 1000/microL and Platelet count \>100,000/microL
* Age \>20 years

Exclusion Criteria:

* Known familial head and neck cancer syndrome
* Pregnancy
* Known HIV
* Patients receiving immunosuppressive drugs
* Inflammatory bowel disease
* Active second malignancy in the last 5 years
* Patients receiving any other investigational agent(s)
* Patients who have received any prior chemotherapy or radiation therapy to the primary head and neck cancer
Phase IIb Safety and Efficacy Study of Four Dose Regimens of BAY1021189 in Patients With Heart Failure and Preserved Ejection Fraction Suffering From Worsening Chronic Heart Failure (SOCRATES-PRESERVED)

Objective of the study is to find the optimal dose of the once daily oral soluble guanylate cyclase stimulator (sGC) BAY1021189 for Phase III that can be given in addition to standard diuretic and comorbidity treatment for heart failure with preserved ejection fraction (HFpEF)


Eligibility Criteria:
Inclusion Criteria:

* Worsening chronic heart failure (WCHF) requiring hospitalization (or intravenous diuretic treatment for HF without hospitalization) with initiation of study treatment after clinical stabilization
* Left ventricular ejection fraction (LVEF) \>/= 45% by echocardiography at randomization

Exclusion Criteria:

* Intravenous inotropes at any time after hospitalization
Efficacy on Helicobacter Pylori Eradication With Two Antibiotic Regimens

Clinical trial to compare efficacy on eradicating Helicobacter pylori with two antibiotic strategies: sequential with amoxicillin and omeprazole 5 days and clarithromycin with metronidazole and omeprazole 5 days or omeprazole with clarithromycin and amoxicillin 14 days.

In patients with documented infection with Helicobacter pylori after endoscopy and biopsy, two modalities of treatment were compared, and after a control endoscopy and biopsy, eradication was assessed as well as side effects of both treatments.

Eligibility Criteria:
Inclusion Criteria:

* Helicobacter pylori infection in biopsy
* Eradication required

Exclusion Criteria:

* Antibiotic received two weeks prior
* Previous treatment for H pylori infection
* Allergy to any of the treatment drugs
* Smoking \> 5 cigarettes daily.
Evaluation of Peer Telephone Cessation Counseling for Smokers

The purpose of this study is to evaluate the peer telephone cessation counseling that has been and continues to be implemented at the Ann Arbor VA as part of the Tobacco Tactics intervention.

Background: As part of the nurse-administered Tobacco Tactics intervention, we developed a novel program to train veterans from Voluntary Services to provide peer telephone cessation counseling calls.

Objectives: The objective of this study is to conduct an in-depth evaluation of the volunteer peer telephone cessation counseling that has been implemented and continues to be implemented at the Ann Arbor Veterans Affairs (VA) hospital as part of the inpatient Tobacco Tactics intervention.

Methods: Using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, this quasi-experimental study will collect both quantitative and qualitative data to evaluate the peer telephone cessation counseling component of the Tobacco Tactics intervention. The Reach of the program will be evaluated by determining differences in the demographics, health characteristics, and smoking characteristics of those who do and do not participate in the peer telephone cessation counseling. The Effectiveness of the program will be evaluated by determining if there were differences in quit rates between those that do and do not participate in the peer telephone cessation counseling. The Adoption and Implementation of the program will be evaluated by determining the satisfaction with the counseling, reasons for nonparticipation, the type and quality of counseling actually provided, and barriers and facilitators to implementing the counseling as perceived by staff. The Maintenance of the program will be evaluated by determining the estimated costs of implementing the peer telephone cessation counseling.

Impact: The Tobacco Use/Smoking Cessation goal of the VA Substance Use Disorders (SUD) Quality Enhancement Research Initiative (QUERI) is to develop, implement and evaluate cost-effective interventions for increasing access to and use of evidence-based smoking cessation treatment. Telephone counseling has been shown to be efficacious and teaching volunteer veterans to provide this service is an option that is likely to be cost effective. Hence, evaluating the peer cessation telephone counseling program at the Ann Arbor VA will provide valuable information as to whether or not the program is a viable option for wider scale dissemination.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria: veterans who received the Tobacco Tactics intervention as an inpatient in the hospital.

Exclusion Criteria:

* The exclusion criteria: veterans who are too ill or impaired to consent.