cyrilzakka/clinical-trials huggingface dataset:
Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine(CAIV-T)in Healthy Adults Aged 18 to 59 and Healthy Adults Aged 60 Years and Older

The purpose of this clinical study was to evaluate immune responses measuring antibodies in serum and secretions and cellular immune responses generated by CAIV-T vaccine in healthy adults aged 18 years and older as a means to develop assays for application in investigating potential immunological correlates of protection and/or establishing assays to measure vaccine take.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged 18 to 59 years or \> 60 years.
* Female subjects of childbearing potential who had a negative urine pregnancy test result prior to study vaccination. Females who were surgically sterile or post-menopausal did not require pregnancy testing.
* Adults who were determined by medical history, physical examination and clinical judgment eligible for this study. Subjects with stable pre-existing disease, defined as disease not requiring change in therapy or hospitalization within 12 weeks before receipt of study vaccination, will be eligible.
* Subjects who provided written informed consent after the nature of the study was explained.
* Subjects who were available for the duration of the study (from enrollment to study completion).
* Subjects who could be reached by study staff for the post-vaccination contact \[via telephone, clinic or home visit\].

Exclusion Criteria:

* For subjects \> 60 years of age only:
* Subjects who resided in a nursing home or long-term care facility or other institution receiving skilled or semi-skilled nursing care. An ambulatory subject who resided in a retirement home or village was eligible for participation.
* Subjects with evidence of dementia or other severe cognitive impairment based on Mini Mental State Examination (MMSE) scores. Note: Prior to study vaccination, all subjects \>60 years of age must have completed a MMSE.

For all study subjects:

* Subjects who were perceived to be unavailable or difficult to contact for evaluation of study visits during the study period.
* Subjects with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids; or cytotoxic agents.
* Subjects who resided in the same household as an immunosuppressed or immunocompromised individual.
* Subjects with a documented history of hypersensitivity to egg or egg protein or any other component of the study vaccine, placebo or TIV.
* Subjects who had a current wheezing episode that was considered a change from the subject's usual clinical state.
Impact of Polyphenols on Endothelial Function in Obstructive Sleep Apnea

Severe obstructive sleep apnea (OSA) is associated with increased cardiovascular morbidity and mortality. Endothelial dysfunction, an early marker of vascular disease has been demonstrated in OSA. Regular treatment of OSA by continuous positive airway pressure (CPAP) improves endothelial function and is associated with a reduction in cardiovascular risk. Approximately 40% of patients with OSA are intolerant or insufficiently adherent to CPAP. Alternative treatments or adjuvants to the CPAP are needed.

The polyphenols have demonstrated their effectiveness in improving endothelial function in patients with CV disease. No randomized controlled studies have evaluated the impact of PPR on the endothelial dysfunction associated with OSAHS.

The endpoint is the change to one month of polyphenols treatment of the endothelial function measured by the index of hyperemic reactivity.

The secondary endpoints are changes at one month of supplementation with polyphenols of ambulatory blood pressure measurement in 24 hours (MAPA), micro-circulatory responsiveness, the speed of the pulse wave and biological measurements (lipid profile, blood glucose, fasting insulin, leptin, adiponectin, hs-CRP, 8-isoprostane levels and cellular origin of microparticles).

Eligibility Criteria:
Inclusion Criteria:•

* apnea hypopnea index \> 30
* accepting polyphenols supplementation
* Signed informed consent

Exclusion Criteria:

* Epworth sleepiness scale \> 16/24
* Severe cardiac and/or respiratory disease
* BMI\>35 kg/m2
* Anemia
Study to Evaluate Immunogenicity, Safety, and Tolerability of ZOSTAVAX™ Vaccine (Zoster Vaccine Live, V211) Administered Concomitantly Versus Nonconcomitantly With Quadrivalent Influenza Virus Vaccine (Inactivated) in Participants ≥50 Years of Age (V211-062)

The study evaluated immunogenicity, safety, and tolerability of ZOSTAVAX™ Vaccine (V211) administered concomitantly versus nonconcomitantly with Quadrivalent Influenza Virus vaccine (inactivated) in participants ≥50 years of age. The primary hypotheses tested 1) the noninferiority of concomitant versus nonconcomitant vaccination with regard to Varicella zoster virus (VZV) Geometric Mean Titer (GMT) antibody responses, 2) the acceptability of geometric mean fold rise in VZV antibody response after concomitant vaccination, and 3) the noninferiority of concomitant versus nonconcomitant vaccination with regard to influenza virus strain-specific GMT antibody responses.


Eligibility Criteria:
Inclusion Criteria:

* Has history of varicella or residence in a VZV-endemic area for ≥30 years
* Is male, female not of reproductive potential, or female of reproductive potential and has a negative pregnancy test and agrees to avoid becoming pregnant throughout the study

Exclusion Criteria:

* Has history of hypersensitivity to any vaccine component
* Has previously received any varicella or zoster vaccine
* Has received an influenza vaccine for the 2015-16 season
* Has history of Herpes zoster
* Has received immunoglobulin, monoclonal antibodies, or any blood products within 5 months before study vaccination
* Is pregnant or breastfeeding, or expecting to conceive during the study
* Has used immunosuppressant therapy
* Has known or suspected immune dysfunction
* Has experienced Guillain-Barré syndrome within 6 weeks
* Has severe thrombocytopenia or any other coagulation disorder
A Trial to Assess the Safety, Tolerability, and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Young Adults Aged >=18 to <26 Years.

This study is looking at a new vaccine that might prevent meningococcal disease, and will study the immune response elicited by this vaccine when given to healthy young adults. The study will also look at the safety of the new vaccine as well as how it is tolerated.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subject aged \>=18 and \<26 years at the time of enrollment.
2. Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
3. Negative urine pregnancy test for all female subjects.

Exclusion Criteria:

1. Previous vaccination with any meningococcal serogroup B vaccine.
2. Subjects who are scheduled to receive 1 or more doses of an HPV vaccine as part of a 3-dose series during the period between Visit 1 and 28 days after the second vaccination.
3. Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
4. A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects in the United States with terminal complement deficiency are excluded from participation in this study.
5. Significant neurological disorder or history of seizure (excluding simple febrile seizure).
6. Current chronic use of systemic antibiotics.
7. Received any investigational vaccines, drugs, or devices within 28 days before administration of the first study vaccination.
8. Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
Two-Layer Method Preservation and Resuscitation of the Cadaveric Pancreas Before Transplantation

The purpose of this project is to compare the effect of oxygenated preservation of the pancreas before transplantation using the "Two-Layer Method" (TLM) against outcomes previously experienced with organs preserved using only standard University of Wisconsin (UW) storage solution. It is our hypothesis that TLM preservation will reduce the frequency and severity of complications of pancreas transplantation, increase the number of organs acceptable for transplantation, and spare individual patients and their families suffering and hardship.

Two-Layer Method (TLM) preservation consists of a storage chamber containing a layer of highly oxygenated, water-immiscible liquid perfluorocarbon (perfluorodecalin, C10F18) surmounted by a layer of conventional UW (or similar) organ preservation solution. The perfluorocarbon is sufficiently dense (\~2 g/ml) that the pancreas floats on top of it, in contact with both layers. The perfluorocarbon combines low toxicity with an oxygen content 75 times greater than the UW solution used in standard pancreas storage. When preserved under these conditions, the pancreas absorbs oxygen by diffusion and steadily consumes it, supporting sufficient aerobic metabolism to maintain tissue ATP concentrations at near-physiologic levels and prevent, or even reverse, pancreas anoxic injury. In animal models of pancreas ischemic and storage injury, TLM preservation has been strikingly successful at improving the outcome of both islet isolation and pancreas transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Listed for pancreas transplantation at the University of Nebraska Medical Center

Exclusion Criteria:

* Ineligibility for medical/surgical/psychosocial reasons for listing for pancreas transplantation at the University of Nebraska Medical Center.
Evaluation of a Primary Type 2 Diabetes Prevention Programme

A type 2 diabetes prevention programme, named PREDIAS was developed. It consists of 12 lessons delivered as group sessions. Die efficacy of PREDIAS was studied in a randomized controlled study with 12 month follow up. Control group received written information about diabetes risk. Primary outcome variable was weight reduction at 12 months follow up. Secondary variables were impact of the intervention on glycemic parameters, lipids, eating and exercise behavior and other metabolic risk factors

The PREDIAS programme was developed based on the interventions used in the Diabetes Prevention Study (DPS, Finland) and the Diabetes Prevention Programme (DPP; USA). The main purpose of PREDIAS was to develop a prevention programme delivered as a group programme to improve cost-benefit ration of diabetes prevention programmes.

Eligibility Criteria:
Inclusion Criteria:

* impaired fasting glucose and/or
* impaired glucose tolerance
* overweight (BMI \> 26 kg/m²)

Exclusion Criteria:

* type 2 diabetes
* severe illness (cancer diagnosis, stroke or myocardial infarction in the last 12 months)
* diagnosis of a current mental disease
Database of Tissue Samples to Understand the Inflammatory Response After Cardiac Surgery

The aim of this study is to collect non-individual related blood samples for the compelling of a unique database of tissue samples to understand the inflammatory responds after cardiac surgery on an on-going basis. This includes especially protein analyses and genetic testing for certain neurotransmitters in the blood and tissues to understand disease markers related to heart disease. The study is designed as an openly recruiting biobank with the purpose to later serve multiple study purposes. Outcomes refer to protein analyses and genetic testing for neurotransmitters in the blood and tissues.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing cardiac surgery

Exclusion Criteria:

* None.
EMA Baseline Screening System for Therapists Who Treat Youths With Depressive Symptoms

Youth depression is a matter of concern worldwide. It affects an important part of the young population around the world and its consequences both physically and mentally make this issue an important research field for psychologists and other health related professionals (Zuckerbrot, Cheung, Jensen, Stein \& Laraque, 2018). Two of the biggest challenges that clinicians and researchers face when dealing with youth depression are adherence and the establishment of a therapeutic alliance (TA; Nock \& Ferriter, 2005). While several treatments are available to relief depressive symptomatology in youths, a significant number do not access them for a variety of reasons (DiMatteo, Lepper \& Corgan, 2000). In the last decades, substantial research has been conducted on how youths and the general population perceive therapy, and different methods have been developed to assess clients and therapists in order to improve outcomes and other aspects of the psychotherapy process, such as feedback tools and real-time measurements like Ecological Momentary Assessment (EMA) (Shiffman, et al., 2008). With the aid of Information Communication Technologies (ICTs) and eMental Health strategies, feedback and assessment tools can be presented in a friendly manner, providing a novel way to possibly improving adherence rates and TA scores. This study aims to develop and test the effectiveness of an Ecological Momentary Assessment mobile application to improve initial adherence and TA in psychotherapy for youths with depression.

The hypotheses for this trial are:

1. Applying an EMA baseline screening application one week before the beginning of treatment for youth depression will significantly improve the TA.
2. Applying an EMA baseline screening application one week before the beginning of treatment for youth depression will significantly improve initial adherence.


Eligibility Criteria:
Inclusion Criteria for Patients:

* Owning a mobile phone with permanent access to the internet,
* Scoring from eleven to nineteen points in the PHQ-9 questionnaire.
* Having completed the eighth grade of basic education.

Exclusion Criteria for Patients:

* Being diagnosed with Depression with psychotic symptoms,
* Having a depressive episode as part of a bipolar disorder diagnosis
* Having suicidal thoughts and/or behaviour as measured by the PHQ-9 and evaluated by the physician.
* Alcohol and/or substance abuse.

Inclusion Criteria for Therapists:

- Having 1 or more years of clinical experience.

Exclusion Criteria for Therapists:

* Having less than 1 year of clinical experience.
* Having participated in the design of PDF reports.
Predictive Factors of Autonomy Loss in Real-life Cohort

The Alzheimer's disease or related disorders (ADRD) are among the most disabling diseases because of their main features such as cognitive impairment, loss of functional autonomy and behavioural disorders. In absence of current curative treatment, the identification of the predictive risk factors of progression of the disease, evaluated through its main symptoms, represents a major stake of public health. The Investigators aim at developing a regional database, which includes the patient medical records on a prospective basis, in collaboration with the medical and administrative staff and with the University hospital computer science departments.

The main objective is to study the predictive factors associated with change in functional autonomy level, measured every 6 to 12 months in centres across Region Auvergne Rhone-Alpes in France.

The real-life study population will consist in about 5400 patients with ADRD. The inclusion period will be of 3 years, the length of follow-up of each patient will be of 10 years max for a total study length of 13 years.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years and older, undergoing a medical visit in a memory center or neuro-cognition service
* Patients living at home or in housing
* Patients with memory impairment, at all stage of the disease

Exclusion Criteria:

* Patients in institution
* Patients under legal protection
* Patients with a hearing or visual impairment, which prevents carrying out examinations
The Role of Inflammation in Ocular Tumours

This prospective, non-therapeutic study will determine whether a novel imaging technique can identify presumptive tumour associated macrophages (TAMs) in patients with ocular tumours.

The investigators will evaluate 5 groups:

1. Choroidal nevus
2. Choroidal indeterminate melanocytic lesion
3. Choroidal melanoma
4. Suspected metastatic tumour (ie, primary tumour elsewhere)
5. Locally treated ocular tumours


Eligibility Criteria:
Inclusion Criteria:

Any tentative clinical diagnosis of:

1. Choroidal nevus (low-risk features):
2. Choroidal indeterminate melanocytic lesion (high-risk features)
3. Choroidal melanoma
4. Suspected metastatic tumour (ie, primary tumour elsewhere)
5. Locally treated ocular tumours

Note that a patient can enroll in this study twice, once before treatment and once after, provided that at least one month has passed since initiation of treatment. This patient will count twice (ie, once in each of two study arms)

Male and female age 18 years and older Ability to provide informed consent

Exclusion Criteria:

* Allergy to angiography dye
* Cases that do not meet the above criteria for tumor size will be ineligible to participate in the study.
* Patients not able to provide consent for the study.
* Patients with a poor view of the fundus due to cataract or vitreous hemorrhage.
* Patients \< 18 years of age. Any concurrent unrelated eye diagnosis
Buprenorphine Formulation Comparison: Sublingual Tablet vs. Solution - 1

The purpose of this study is to compare subject response to liquid vs. tablet formulations, to assess bioequivalency of liquid vs. tablet, to compare subject preference, and to evaluate if dose response curve for tablet is equal to liquid form."

1) Compare subjects response to liquid vs tablet formulation 2) Assess bioequivalency of liquid vs tablet 3)Compare subject preference 4) Evaluate if dose response curve for tablet = to liquid form

Eligibility Criteria:
Inclusion Criteria:

M/F ages 18-65. Meet DMS-IV criteria for opiate dependence. Agree to conditions of the study and sign informed consent.

Exclusion Criteria:

Pregnant or nursing women. Acute medical condition that would interfere with study participation or put safety of subjects in jeopardy. Current daily use of anti-convulsants, antabuse or neuroleptics. DSM-IV diagnosis of ETOH or sedative/hypnotics dependence.
Swiss Study on Spider Bites

About spider bites in Middle Europe, there are published only a dozen cases. The investigators suspect that they may be much more frequent than reflected by the literature analysis (but much less dangerous than thought by people). From June 1st 2011 to November 30st 2012 the investigators collect clinical data on patients treated for spider bites in Switzerland.

Inclusion criteria: Every human treated for suspected spider bite in Switzerland willing to participate this study.

Eligibility Criteria:
Inclusion Criteria:

* adult or child treated for a suspected spider bite in Switzerland

Exclusion Criteria:

* unwillingness to participate to the study
A Pilot Study to Measure Blood Levels of Desflurane in Children

In this feasibility study we will collect blood from indwelling arterial catheters in up to 20 patients undergoing non-emergent surgery with desflurane anesthesia at Children's Hospital of Philadelphia. Desflurane levels will be determined by high pressure liquid chromatography (HPLC).

Our eventual goal is to quantify fetal levels of desflurane in umbilical cord blood during fetal surgery. We propose a pilot study to assess the ability of our assay to measure desflurane in human blood.

Fetal surgery is an evolving field. Some previously fatal diseases can be surgically corrected before birth. Animal models of the procedures have been carefully translated to humans, but less is known about anesthetic techniques. In children, inadequate anesthesia results in greater stress responses as shown by cardiovascular, neuro-endocrine, and metabolic changes. These stress responses have been associated with poorer outcomes. One of the major goals of anesthesia for these procedures is to attenuate this stress response. Fetuses get intramuscular opioids before their incision, and the mother is given high doses of volatile anesthetic (desflurane) with the assumption that whatever amount of desflurane crosses the placenta adequately anesthetizes the fetus. No studies have quantified the fetal levels of desflurane.

High pressure liquid chromatography (HPLC) has been used to measure levels of volatile anesthetic in various tissues. Measurement of desflurane has been challenging because of its higher boiling point (23.5 °C at one atmosphere pressure) when compared to older volatile anesthetics such as sevoflurane (boiling point 58.6 °C) and isoflurane (boiling point 48.5 °C). With techniques in cold rooms and using ice for sample transport, investigators have successfully measured desflurane levels in blood and brain tissue of mice.

Our eventual goal is to quantify fetal levels of desflurane in umbilical cord blood during fetal surgery, but we first propose a pilot study to assess and refine the ability of our assay to measure desflurane in human blood.

Eligibility Criteria:
Inclusion Criteria:

1. Children between 1 and 18 years old
2. Weight \>10 kg
3. Scheduled for elective surgery
4. Patient will have an arterial catheter placed as routine care for the surgery
5. Informed consent (and assent if applicable)

Exclusion Criteria:

1. Desflurane not used as part of anesthetic
2. Preoperative hemoglobin less than 9 mg/dl
3. Any investigational drug use within 30 days prior to enrollment
4. Pregnant or lactating females
Comparison of Core Muscle Asymmetry Using Spine Balance 3D in Patients With Arthroscopic Shoulder Surgery

This study is an observational cross-sectional study. Post-operative patients need an immobilization period for a certain period of time after surgery. Kinetic chain changes due to immobilization can affect the symmetry of the core muscle. Therefore, in this study, core muscle asymmetry (CMA) is measured using a whole body tilt device for inpatients who have undergone arthroscopic shoulder surgery. We would like to make a clinical suggestion for post-operative rehabilitation by identifying the characteristics of CMA according to the left or right site.


Eligibility Criteria:
Inclusion Criteria:

* arthroscopic shoulder surgery
* limit of motion due to shoulder pain

Exclusion Criteria:

* orthopedic surgery or other medical history in the lower extremities
* neurological history or are taking related medications
* chronic headache or disease related to the inner ear
* cardiovascular disease that may affect balance ability or take related medications
* acute dizziness
* when performing other balance training