cyrilzakka/clinical-trials huggingface dataset:
D2560C00015 FluMist Annual Safety Study 2018

This prospective annual release study is designed to evaluate the safety of 2 new influenza virus vaccine strains to be included in FluMist Quadrivalent for the 2018-2019 influenza season.

This prospective. randomized, double-blind. placebo-controlled release study will enroll approximately 300 healthy adults 18 to 49 years of age (not yet reached their 50th birthday). Eligible subjects will be randomly assigned in a 4:1 fashion to receive a single dose of bivalent vaccine or placebo by intranasal spray. Randomization will be stratified by site. This study will be conducted at 2 sites in the United States of America. Each subject will receive 1 dose of investigational product on Day 1. The duration of study participation for each subject is the time from study vaccination through 180 days after study vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 through 49 years
* Written informed consent
* Subject available by telephone
* Ability to understand and comply with the requirements of the protocol, as judged by the Investigator

Exclusion Criteria:

* Concurrent enrollment in another clinical study up to 180 days after receipt of investigational product (Day 181)
* History of hypersensitivity to any component of the vaccine, including egg or egg protein or serious, life threatening, or severe reactions to previous influenza vaccinations
* Any condition for which the inactivated influenza vaccine is indicated, including chronic disorders of the pulmonary or cardiovascular systems (example (eg\], asthma), chronic metabolic diseases (eg, diabetes mellitus), renaldysfunction, or hemoglobinopathies that required regular medical follow-up or hospitalization during the preceding year
* Acute febrile (greater than \[\>\]100.0 degrees Fahrenheit \[F\] oral or equivalent) and/or clinically significant respiratory illness (example, cough or sore throat) within 14 days to randomization
* Any known immunosuppressive condition or immune deficiency diseases, including human immunodeficiency virus infection, or ongoing immunosuppressive therapy
* History of Guillain-Barre syndrome.
Active Screening of Arterial Hypertension by Community Outreach Workers in the Cayenne Metropolitan Area to Reduce the Incidence of Cardiovascular Disease

The main objective is to implement of a community-based primary care intervention against high blood pressure. We want to show that this intervention decreases the incidence of stroke in the community of agglomerations of the central coast of French Guiana, with a rapid effectiveness of about -30% at 2 years.

The hypothesis of the research is that, thanks to a strategy of early detection of hypertension based on "outreach" by community relays, it will be possible to increase the effectiveness of primary prevention among the precarious population (early treatment, access to healthcare, improvement of therapeutic follow-up, reduction of renunciations and interruptions of treatment). This strategy, adapted to the Guianese context, would make it possible to reduce the incidence and mortality of cardiovascular diseases among the most vulnerable people, particularly stroke. Such data would be a prerequisite for a more ambitious strategy, aiming to implement policies on a sufficient scale policies on a scale and intensity sufficient to have an impact on the problem of social inequalities in health other than those related to high blood pressure.

The quasi-experimental before-and-after methodology makes it possible to compare, on a population basis, a quantitative endpoint - in this case the number of strokes - between before and after the implementation of a public health intervention. For reasons of acceptance by the partners, statistical power, and potential bias, a before-and-after design seems more interesting.

It will be a pre-screening of hypertension, a possible referral for medical care or opening of health care rights and health education through hygienic and dietary advice and health prevention focused on hypertension.

Eligibility Criteria:
Inclusion Criteria:

* Adults of at least 18 years old
* Residents of the agglomeration community of the central coast of French Guiana.

Exclusion Criteria:

* Person who has objected to participating in the study
* Person under guardianship or curatorship, persons under protective supervision
Systemic Zinc Sulphate in Treatment of Recurrent Aphthous Ulcerations:A Doubleblind, Placebo Controled Study

Recurrent aphthous stomatitis (RAS) is one of the most common of oral mucosa diseases that affects approximately 20% of the general population. Despite the fact that clinical, pathologic and therapeutic feature of the disease has been comprehensively studied, the pathophysiology of aphthous ulcers remains incompletely understood.

Zinc is a potent catalyst of wound healing and zinc deficiency may be a common cause of delayed tissue repair. Use of zinc sulfate in promotion wound healing and preservation of epithelial integrity advocated its possible use in the treatment or prevention of recurrent oral ulcers.

The purpose of the present study was to determine of systemic zinc sulphate in the treatment of recurrent aphthous stomatitis.

Recurrent aphthous stomatitis (RAS) is a chronic inflammatory disease of man characterized by painful ulceration recurring with varying frequency. The pathophysiology of aphthous ulcers remains partly understood. The primary disorder appears to be the result of activation of the cell-mediated immune system. Aphthous ulcers may have abnormalities in cell communication and epithelial integrity. The diagnosis of aphthous ulcers is primarily clinical. Aphthous ulcers occur on areas of nonkeratinized mucosa of the mouth particularly the buccal mucosa, the labial mucosa, the floor of the mouth, the ventral surface of the tongue, and the soft palate. The treatment of recurrent aphthous stomatitis (RAS) still remains unclear and is based mainly on experimental data. The purpose of therapy include the management of pain and functional injury by suppressing inflammatory responses, in addition to reducing the frequency of recurrences or keeping away from the onset of new ulcers .Zinc has been identified as an important factor in repair of tissue.After considerable searching zinc was recognized as the beneficial impurity and a effective factor in healing .The goal of this study is to present the efficiency of dietary zinc supplements in the rate of Recurrent aphthous stomatitis healing.

Eligibility Criteria:
Inclusion Criteria:

1. A history of Recurrent aphthous stomatitis
2. Patients who had symptoms such as burning sensation, pain
3. Patients not on any immunosuppressive or immunomodulatory treatment .
4. Patients of both sexes over 10 years with recurrent aphthous stomatitis
5. Patients who gave written informed consent
6. Patients who were willing for evaluation after therapy and every 1 month up to 5months

Exclusion Criteria:

1. Participants demonstrating drug consumption in the 7 past months
2. pregnancy or lactation
3. Any kind of localized or systemic disease, especially ulcerative colitis , chorn disease and Bechet's syndrome
4. Smokers
5. patients receiving immunosuppressive treatments or any kind of systemic or local drugs especially systemic antibiotics (in past 2 weeks ) and oral antihistamines( in past month ) were either eliminated or asked to discontinue their treatment for a minimum of one month before entering the investigation.
Safety and Efficacy of Switching to a FDC of B/F/TAF From E/C/F/TAF, E/C/F/TDF, or ATV+RTV+FTC/TDF in Virologically Suppressed HIV-1 Infected Women

The primary objective of this study is to evaluate the efficacy of switching to a fixed-dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing on a regimen consisting of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF), elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF), or atazanavir (ATV) + ritonavir (RTV) + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in virologically suppressed HIV-1 infected women.


Eligibility Criteria:
Key Inclusion Criteria

Medically stable HIV-1 infected women who meet the following criteria:

* Completion of the Week 48 open-label extension (OLE) visit or any post Week 48 OLE visits in Gilead-sponsored study GS-US-236-0128, or Completion of the Week 96 visit or any post Week 96 visits in Gilead-sponsored study GS-US-292-0109 or completion of the Week 144 visit or any post Week 144 visits in Gilead sponsored studies GS-US-292-0104 or GS-US-292-0111.
* Currently on a stable antiretroviral regimen consisting of E/C/F/TAF, E/C/F/TDF, or ATV+RTV+FTC/TDF continuously for ≥ 12 consecutive weeks preceding the Screening visit
* Documented plasma HIV-1 RNA levels \< 50 copies/mL for ≥ 12 weeks preceding the Screening visit. After reaching HIV-1 RNA \< 50 copies/mL, single values of HIV-1 RNA

  ≥ 50 copies/mL followed by re-suppression to \< 50 copies/mL is allowed
* HIV-1 RNA \<50 copies/mL at screening
* Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min (≥ 0.83 mL/sec) according to the Cockcroft-Gault formula at the Screening visit

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Exercise for Women With Peripheral Arterial Disease

Hypothesis #1. Supervised exercise rehabilitation will result in greater increases in exercise performance, peripheral vascular function, and health-related quality of life than compared to the attention-control group.

Hypothesis #2. The change in peripheral vascular function will be predictive of improved exercise performance following the supervised exercise program.


Eligibility Criteria:
Inclusion Criteria:

* women 60 years of age and older having a positive history of intermittent claudication assessed by the San Diego Claudication Questionnaire
* exercise limited by intermittent claudication during a screening treadmill test using the Gardner protocol
* an ankle/brachial index (ABI) \< 0.90 at rest or \< 0.73 immediately following the treadmill exercise test
* at least one year past menopause

Exclusion Criteria:

* absence of PAD (peripheral artery disease)
* asymptomatic PAD (Fontaine stage I)
* rest pain due to PAD (Fontaine stage III)
* tissue loss due to PAD (Fontaine stage IV)
* medical conditions that are contraindicative for exercise according to the American College of Sports Medicine (e.g., acute myocardial infarction, unstable angina, etc.)
* use of medications indicated for the treatment of intermittent claudication (cilostazol and pentoxifylline) initiated within three months prior to investigation)
* cognitive dysfunction (mini-mental state examination score \< 24)
* active cancer, renal disease, or liver disease
* a calf skin fold measurement \> 50 mm, because of potential interference with the light path of the near-infrared spectroscopy probe from penetrating the subcutaneous tissue
* pulse arterial oxygen saturation of the index finger \< 95% because of the potential deleterious effect on calf muscle StO2 from poor pulmonary gas exchange
SYSTEMATIC: NAATS of Pooled Selftaken Versus Clinicantaken Swabs 1

Routine screening for gonorrhoea and chlamydia involves urine samples in males and selftaken vulvovaginal swabs (VVSs) in females. As well as infecting the urethra (pee tube) and cervix (neck of womb), gonorrhoea and chlamydia may also infect the rectum (bottom) and throat (both called extragenital sites), often with no symptoms. In some people infection will be found at more than one site, but in others it will only be in one, and if all anatomical sites are not tested some infections will be missed. In certain women one third of infections may be missed, in men who have sex with men (MSM) up to 90% may be missed, if extragenital swabs are not taken. Currently, routine community testing does not include extragenital sites. Until recently these samples could not easily be taken outside clinical settings (hospitals, clinics or surgeries), but new DNA tests for gonorrhoea, called NAATs, now make this possible.

However, they are expensive, and taking samples from extragenital sites would treble the costs. We propose that swabs from the three sites per person are pooled and analysed together rather than tested separately. This method would identify whether the person had the infection but not the anatomical site; this would not alter the management of the individual. Swabs from the rectum and throat have historically been taken by clinicians (doctors or nurses). The main attraction of community screening is that it is client led using selftaken samples. Recent studies suggest that selftaken swabs from the rectum and throat are acceptable to clients and may be as good as swabs taken by clinicians, but the costeffectiveness of this approach has not been investigated. Our aim is to establish whether in MSM and females selftaken samples that are pooled and processed by NAATs are as effective as the individual tests taken by clinicians.


Eligibility Criteria:
Inclusion Criteria:

* Attending the Leeds Centre for Sexual Health for an appointment where diagnostic tests for gonorrhoea and chlamydia will be taken Aged 16 or over

Exclusion Criteria:

* Attending the Leeds Centre for Sexual Health for an appointment where diagnostic tests for gonorrhoea and chlamydia will be taken Aged 16 or over
Safety and Efficacy Assessment of Diagnostic Microprobe (inPROBE) in Women at High Risk of Breast Cancer (Part I Study)

The purpose of this study is to preliminarily determine the correlation of HER2 receptor levels detected with the inPROBE diagnostic probe relative to receptor status as determined by standard methods (IHC/FISH), in women with both HER2-positive and HER2-negative breast cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of written informed consent to participate in the clinical investigation;
2. Female patient aged ≥ 18 to ≤ 75 years;
3. The patient's overall health status as determined by Eastern Cooperative Oncology Group (ECOG) from 0 to 1;
4. Preserved full ability to communicate with the investigator and to understand and comply with the requirements of the Clinical investigation plan;
5. High likelihood of attending follow-up appointments in accordance with the study design and completing this study in accordance with this Clinical investigation plan.
6. The presence of a malignant neoplasm (breast cancer) confirmed by histopathologic examination of material from a gross needle biopsy of the tumor, with specific HER2 receptor status.
7. Patient referred for surgical treatment of breast cancer.

Exclusion Criteria:

1. History of treatment with trastuzumab, or other HER 2 receptor-binding antibody, as part of neoadjuvant (induction) therapy for currently diagnosed and treated breast cancer.
2. A skin disorder that prevents or contraindicates to perform a probe examination in the opinion of the investigator;
3. Breast inflammation/infection on the day of the probe examination;
4. Allergy to any component of the medical device that is the subject of this clinical investigation;
5. An implant in the breast where the inPROBE study and surgery will be performed;
6. Any physical or psychiatric condition, or laboratory test values outside the normal range, which in the opinion of the investigator constitute a contraindication to the patient's participation in this clinical investigation or pose a risk of exclusion from the study or premature termination of participation in the study;
7. Any clinically significant abnormality in physical examination, vital signs, or laboratory tests that, in the opinion of the investigator, is a contraindication to participation in this clinical trial;
8. Pregnancy or breastfeeding;
9. Participation in another clinical trial within 30 days prior to signing informed consent to participate in this clinical investigation;
Serum Levels of Angiotensin Converting Enzyme in Systemic Lupus Erythematous Patients

Systemic lupus erythematosus (SLE) is a heterogeneous autoimmune disease that involve many different organs and display a variable clinical course.The prevalence of SLE varies across gender, race/ethnicity, and geographic regions. SLE demonstrates a striking female predominance with a peak incidence of disease during the reproductive years. In adults, the female to male ratio is 10- Renal involvement is common in SLE and is a significant cause of morbidity and mortality. It is estimated that as many as 90% of patients with SLE will have pathologic evidence of renal involvement on biopsy, but clinically significant nephritis will develop in only 50%. AII is a potent pro-inflammatory modulator with the ability to augment the immune responses in renal and non-renal tissues. Specifically in the kidney, AII stimulates mononuclear cells, favoring hyperplasia and hypertrophy of mesangial, tubular cells and interstitial fibroblasts, and increases expression and synthesis of the extracellular protein matrix leading to fibrosis.

Angiotensin II and strong candidate for a mediator of the development and progression of renal disease in SLE has been found to promote glomerular cell proliferation, alter growth factor expression, and activate proinflammatory cytokines, all of which promote glomerulosclerosis


Eligibility Criteria:
Inclusion Criteria:

* 1-Patients who fulfill the 2019 American College of Rheumatology/European League against Rheumatism classification criteria of Systemic Lupus Erythematosus 2-Patients diagnosed as lupus nephritis , actually did renal biobsy 3-Patients who is able to give informed consent to join the study

Exclusion Criteria:

* - Any patient with any collagen disease other than systemic lupus erythematosus.
Dilute Povidone-iodine Irrigation vs No Irrigation for Children With Acute, Perforated Appendicitis

The goal of this study is to compare the efficacy of PVI irrigation to no irrigation for decreasing postoperative intra-abdominal abscesses in children with perforated appendicitis. Additionally, this study aims to verify the safety profile of dilute PVI for intra-abdominal irrigation.

Postoperative intra-abdominal abscesses are common occurrences after perforated appendicitis in pediatric patients despite utilization of evidence-based practices. Povidone-iodine is a commonly used antiseptic in surgical procedures and has been shown to be effective in reducing postoperative abscesses in adults with perforated appendicitis. This trial will be the first to rigorously test the efficacy of povidone-iodine irrigation in children and to verify its safety profile in this patient population.

Eligibility Criteria:
Inclusion Criteria:

* Children who undergo an appendectomy for perforated appendicitis. (Appendicitis: Diagnosis is made intraoperatively by the surgeon. Diagnosis Method: The visualization of a gross defect in the appendiceal wall or the presence of intraperitoneal stool or a fecalith at the time of operation.)

Exclusion Criteria:

* Patients presenting with simple or gangrenous appendicitis
* Patients with a history of iodine sensitivity, thyroid disease or renal disease
* Patients undergoing interval or incidental appendectomy
* Patients/parents/legal guardians who are both non-English and non-Spanish speaking
MOdularity for SEnsory Motor Control

For this project the investigators ask, how the activation and organization of muscle synergies may be disrupted by brain lesions, and whether it is possible to modify synergy activations by means of specific therapies. Will be investigated whether there is a relationship between post-stroke cortical plasticity and changes in synergy activations due to a therapy.

It has been widely recognized that neurorehabilitation can facilitate recovery of motor function after stroke. There has been increasing evidence suggesting that the execution of voluntary movement relies critically on the functional integration of the motor areas and the spinal circuitries. More precisely, it was suggested that the central nervous system may generate neural motor commands through a linear combination of spinal modules, each of which activates a group of muscles as a single unit (muscle synergy). The investigators hypothesize that descending motor cortical signals generate movements by combining and activating muscle synergies. With this background, the goal is to further improve the efficacy of rehabilitation utilizing knowledge on modular motor control. The investigators also seek to provide a better understanding of the links between brain activations and movements.

The project MO-SE has three aims, one primary and two secondary. The main primary aim is to test whether the use of virtual reality rehabilitation based therapies are superior in terms of clinical efficacy to conventional therapies (randomized clinica trial, RCT). The other two secondary aims of the project will be accomplished with further instrumental analysis in sub-samples of the group of patients enrolled for the RCT.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of first stroke;
* a score between 1 and 3 (included) at the upper limb sub-item on the Italian version of the National Institute of Health stroke scale (IT - NIHSS) (Pezzella et al., 2009)
* a score higher than 6 out of 66 on the Fugl - Meyer upper extremity (F-M UE) scale (Fugl-Meyer et al., 1975).

Exclusion Criteria:

* the presence of a moderate cognitive decline defined as a Mini Mental State Examination (Folstein et al., 1975) score \< 20/30 points;
* the finding of severe verbal comprehension deficit defined as a number of errors \> 13 (Tau Points \< 58/78) on the Token Test (Huber et al., 1984);
* evidence of apraxia and visuospatial neglect interfering with upper arm movements and manipulation of simple objects in all the directions within the visual field, as assessed through neurological examination;
* report in the patient's clinical history or evidence from the neurological examination of behavioural disturbances (i.e. delusions, aggressiveness and severe apathy/depression) that could affect compliance with the rehabilitation programs;
* non stabilised fractures;
* diagnosis of depression/delusion;
* associated traumatic brain injury;
* drug resistant epilepsy;
* evidence of ideomotor apraxia;
* evidence of visuospatial neglect;
* severe impairment of verbal comprehension defined as a score higher than 13 errors on Token test (i.e. score\<58 out of 78 Tau points).
Trabeculectomy Versus Canaloplasty to Treat Glaucoma

The aim of the study is to investigate pressure lowering effect of two surgical methods canaloplasty and trabeculectomy in patients with open angle glaucoma, in which under local pressure lowering therapy the progression of the disease could not be stopped, and thus a pressure lowering surgical intervention is necessary. The risks in the postoperative course in Canaloplasty in the literature as lower than for the trabeculectomy with mitomycin-C. Conversely, large glaucoma centers questioning the effectiveness of permanent pressure lowering of canaloplasty. Precisely this question is investigated in the study.


Eligibility Criteria:
Inclusion Criteria:

* patients with open angle glaucoma and excavation of 0.4 - 0.8
* 60 eyes of 60 patients (30 patients for trabeculectomy, 30 patients for Canaloplasty) The ratio of female / male is not involved.
* Eye pressure under local therapy: 20mmHg and above (corrected with pachymetry table).
* Local drug therapy: at least 2 eye pressure lowering ingredients or absolute intolerance to preservatives or eye drops.
* general anesthesia possible.
* The operation must be signed by the surgeon as a state-of-the-art performed without complication to be evaluated. If the operation does not meet this criterion, the patient is excluded from the study.

Exclusion Criteria:

* all patients are not included in the group of inclusion criteria, or:
* Phenprocoumon therapy.
* operation is not done state-of-the-art.
* after the surgery: additional eye pressure lowering surgery, cataract surgery, keratoplasty, laser surgery in the anterior eye segment (except suture lysis after trabeculectomy)
* Uveitis, or possible inflammation of the eye
* Previous eye pressure lowering operations or laser interventions
* Corneal Refractive Surgery (pseudophakia allowed)