cyrilzakka/clinical-trials huggingface dataset:
Assessement of Viral Shedding Duration After a Respiratory Tract Infection in Oncology and Hematology Patients

The purpose of this study is to assess the duration of the viral shedding in hematology and oncology patients after a respiratory tract viral infection. This duration has not been much studied in that population whereas it is probably longer than that in immunocompetent patients. Thereby it may be a source of transmission amongst these immunocompromised patients.

The development of multiplex polymerase chain reaction (PCR) tests has greatly improved the diagnosis of respiratory tract viral infections by increasing its sensitivity and the diversity of viral species detected. However, there are few data concerning respiratory tract viral infections amongst hematology and oncology patients. Especially, the duration of viral shedding following an infection has not been much studied whereas it is a source of inter-individual transmission between immunocompromised patients who are more likely to develop severe disease.

Studies conducted so far concerned mainly hematology patients. They have shown that viral carriage could last up to one month and a half in some patients with hematological malignancy.

The aim of this study is to determine the duration of the viral shedding in patients from hematology and oncology units after a respiratory tract viral infection for the ten main viruses involved in order to better manage these infections and to better prevent their transmission.

Eligibility Criteria:
Inclusion Criteria:

* Patient with solid organ cancer or haematological malignancy with or without chemotherapy
* Having symptoms of upper and/or lower respiratory tract infection
* Virus detected by PCR in nasal sample
* Signature of consent

Exclusion Criteria:

* Hematological stem cell and solid organ recipients
* No health insurance
* protected people
A New Model to Reach Vulnerable Older Adults With Pain Self-management Support

Learning chronic pain self-management skills can help patients improve daily functioning and quality of life, while avoiding risks associated with opioids and other pharmacological treatments. Community health workers (CHWs) may help make chronic pain self-management interventions more accessible to older adults living in underserved communities. The goal of this study is to conduct a feasibility test of a chronic pain self-management intervention delivered by CHWs, in conjunction with mobile health tools, in a sample of 25 older adults recruited from community sites in Detroit, Michigan. This study will involve the use of mixed quantitative and qualitative methods to assess participant engagement and satisfaction, and change in pain-related outcomes.


Eligibility Criteria:
Inclusion Criteria:

* English-proficient
* Age \>= 60 years
* Ambulatory with or without assistive device
* Community-living
* Have a cell or landline phone
* Have Internet access (home or elsewhere)
* Self-reported chronic musculoskeletal pain (pain in muscles or joints for \> 3 months); \>4 (0-10 scale) average pain level over last week; \>1 day/previous 30 when pain made it difficult to do usual activities
* Ability to attend a one-time study orientation session

Exclusion Criteria:

* Serious acute illness or hospitalization in last month
* Planned surgery in next three months
* Significant cognitive impairment as indicated by affirmative response to question: "Do you have significant difficulties with your memory that get in the way of your usual daily activities?"
* Other severe physical or psychiatric disorder judged by study team to pose significant barrier to deriving program benefit.
Outcome Study Following Reimbursement Changes in the Use of Fixed Combination Inhalers in Patients With Asthma or Chronic Obstructive Pulmonary Disease

To investigate how a switch from fixed combination treatment (ICS and LABA) to other treatments influence asthma or COPD treatment failure


Eligibility Criteria:
Inclusion Criteria:

* All patients who was on treatment with fixed combination asthma or COPD therapy by January 1 2010
Assessment of the Safety and Efficacy of BRM421 Ophthalmic Solutions in Dry Eye Subjects.

The objective of this study is to compare the safety and efficacy of BRM421 OS to vehicle for the treatment of the signs and symptoms of dry eye disease.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age;
* Provide written informed consent;
* Have a reported history of dry eye prior to enrollment;
* Have a history of use or desire to use eye drops;

Exclusion Criteria:

* Have any clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
* Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
* Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
* Have used any eye drops within 2 hours of Visit 1;
* Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
* Be a woman of childbearing potential who is not using an acceptable means of birth control;
Vaccination Against Influenza in Autoimmune Diseases

The project is to evaluate immunogenicity, efficacy and tolerance of vaccination against influenza (seasonal and H1N1) in patients affected with systemic and autoimmune diseases.

This prospective study concentrates on patients with vasculitis, systemic sclerosis, Sjögren's syndrome, systemic lupus erythematosus and other connective tissue diseases.

Patients responding to the inclusion criteria, will receive vaccine against seasonal influenza then, 3 weeks later, vaccine against H1N1 influenza. According to the results of ongoing trials a second injection of H1N1 vaccine has been scheduled 3 weeks later. At each consultation a blood sample will be taken to evaluate immunogenicity of vaccination. Two additional consultations have been scheduled: one month after the last vaccine administration and at 6 month, in order to evaluate the occurrence of late side effects.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients presenting autoimmune and systemic diseases,
* treating or not with steroids, and/or immunosuppressants and/or biotherapies, especially vasculitis, scleroderma, Sjogren's syndrome and systemic lupus (main groups)

Exclusion Criteria:

* Absence of informed consent
* Disease which did not responded to the above criteria
* Active infection at time of vaccination
* HIV infection
* History of Guillain-Barre syndrome
* Allergy to one component of the vaccine
Blood and Stool Sample Collection in Subjects Participating in Colorectal Cancer Screening: Act Bold

The primary objective of this study is to collect de-identified, clinically-characterized stool and whole blood specimens for use in developing and evaluating the performance of new biomarker assays for detection of colorectal cancer (CRC).

Subjects will be men and women, 40 years of age or older who are scheduled for a colonoscopy. Approximately 7,500 subjects will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Subject is male or female, 40 years of age or older.
* Subject is at average or increased risk for development of CRC.
* Subject presents for screening or surveillance colonoscopy.
* Subject has no symptoms that require immediate, or near term, referral for diagnostic or therapeutic colonoscopy.
* Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.

Exclusion Criteria:

* Any previous cancer diagnosis (with the exceptions of basal cell or squamous cell skin cancers) and/or cancer related treatment (e.g. chemotherapy, immunotherapy, radiation, and/or surgery) within the past 5 years.
* Subject has a diagnosis or personal history of any of the following conditions, including:

  1. Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome).
  2. Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome").
  3. Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Neurofibromatosis and Familial Hyperplastic Polyposis.
* Subject has a family history of:

  1. Familial adenomatous polyposis (also referred to as "FAP").
  2. Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome").
* Subjects with Cronkhite-Canada Syndrome.
* IV contrast (e.g. CT and MRI) within 1 day \[or 24 hours\] of blood collection.
* Subject has any condition that in the opinion of the Investigator should preclude participation in the study
Treatment of Metastatic Melanoma With Autologous Melan-A/MART-1 Specific CTL Clones

Most of HLA-A2 melanomas express Melan-A/MART-1 antigen and are recognized by tumor reactive Melan-A specific T lymphocytes. By using blood samples from HLA-A2 melanoma patients (stage III and IV), our goal is to produce a tumor reactive Melan-A specific T cell clones and to conduct a phase I-II clinical trial, based on the infusion of several millions to several billions of these lymphocytes to the patient, in order to induce passive immunity against this antigen. Production of the clones will be performed in the Unit for Cellular and Gene Therapy from Nantes University Hospital. Therapeutic response, safety treatment but also localization and survival of infused T cell clones will be assessed. This approach is expected to precise the ability of the clones to migrate within the tumor and to transfer specific immunity.


Eligibility Criteria:
Inclusion Criteria:

* HLA-A2 melanoma patients with :

  * either loco-regional or lymph node metastasis
  * transit nodules not surgically resectable
  * measurable cutaneous or visceral metastasis
* Patients' tumor express Melan-A/MART-1 antigen.
* No chemotherapy treatment (except for Deticene used before the first T cell clones infusion) or radiotherapy or immunotherapy in the last 4 weeks before infusion.
* No other melanoma treatment during the protocol.
* Life expectancy should be greater than 6 months.
* General state with Karnowsky greater than 80, ECOG = 0, 1 or 2.
* Patient should be negative for HIV and B and C hepatitis.
* Biological parameters at the beginning of the study: leucocytes ³ 2000 elements per mm3, hemoglobin ³ 10.5g/dl, platelets ³ 100 000 per mm3, phosphatases alcalines transaminases £ 1 time 1/2 compared to the normal.
* Signed informed consent

Exclusion Criteria:

* Cardio-vascular pathologies, evoluting and uncontrolled, (severe HTA), cardiac deficiency, severe angor, severe arrhythmia.
* Infectious pathologies evoluting and requiring antibiotherapy.
* Patients HIV+.
* Transplanted patients or patients suffering from severe auto-immune disease.
* Psychiatric troubles that do not allow the protocol follow-up.
* Pregnant or breast-feeding women.
* No contraception.
Fish Oil and Alpha Lipoic Acid in Treating Alzheimer's Disease

The purpose of this study is to determine the effect of fish oil and the antioxidant alpha lipoic acid on factors in the blood that are associated with the progression of Alzheimer's Disease (AD).

Alzheimer's disease (AD) is a serious condition associated with increased inflammation, cholesterol, and oxidative stress (a condition involving an excess of free radicals and a decrease in antioxidant levels). Fish oil and alpha lipoic acid, which have few side effects, may help relieve these problems; therefore, these supplements may slow the progression of AD, particularly when given in combination. This study will evaluate the effect of fish oil and alpha lipoic acid on inflammation, lipid levels, and oxidative stress.

Participants in this study will be randomly assigned to receive fish oil alone, fish oil and alpha lipoic acid, or placebo for 1 year. AD rating scales as well as urine and blood tests will be used to assess participants. Participants will have monthly clinic visits during the study to monitor adverse events and to undergo various laboratory tests.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of probable Alzheimer's Disease or mild cognitive impairment
* Mini Mental State Examination (MMSE) score between 18 and 26
* Clinical Dementia Rating (CDR) of 0.5 or 1.0
* Fluent in English

Exclusion Criteria:

* Use of lipid lowering medications
* Consumption of fish of more than twice a week
* Use of omega and alpha lipoic acid supplements
* Use of systemic corticosteroids, neuroleptics, anti-Parkinsonian agents, or narcotic analgesics
* Depression
* Any other serious health conditions that may interfere with the study
* Enrollment in another clinical trial
Persistence of Bactericidal Antibodies in Adults Who Received a Booster Dose of Menactra® Approximately 4 Years Earlier

The aim of this study is to provide information on the persistence of bactericidal antibodies following Menactra booster vaccination in study MTA77 ( NCT01442675).

Objective:

* To evaluate the persistence of antibody responses (determined by a serum bactericidal assay using human complement (SBA-HC)) approximately 4 years after the administration of a booster dose of Menactra vaccine in trial MTA77

All eligible subjects will provide 1 blood sample at Visit 1. The duration of each subject's participation in the trial will be the duration of 1 visit (for enrollment and blood draw)

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years on the day of inclusion
* Received booster dose of Menactra vaccine in trial MTA77
* Informed consent form has been signed and dated
* Able to attend the scheduled visit and to comply with all trial procedures.

Exclusion Criteria:

* Participation at the time of trial enrollment (or in the 4 weeks preceding trial enrollment) in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
* Receipt of any meningococcal vaccine, including serogroup B meningococcal vaccine, after receipt of the booster dose of Menactra vaccine administered in trial MTA77
* Receipt of immune globulins, blood or blood-derived products in the past 3 months
* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
* History of meningococcal infection, confirmed either clinically, serologically, or microbiologically
* Bleeding disorder, thrombocytopenia, or receipt of anticoagulants contraindicating venipuncture at the discretion of the Investigator
* Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
* Current alcohol abuse or drug addiction
* Any illness that, in the opinion of the Investigator, might interfere with trial conduct or trial results
* Receipt of oral or injectable antibiotic therapy within 72 hours prior to the blood draw. (A prospective subject should not be included in the trial until 72 hours has passed.)
* Identified as an Investigator or employee of the Investigator or trial center with direct involvement in the proposed trial, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed trial.
Effects of Repeated Short-term Microgravity During Parabolic Flight Conditions on Neuro-endocrine, Immune and Metabolic Changes

From previous parabolic flight campaigns completed by our research group investigators gathered data showing important changes in neuro-endocrine and also immunological changes. This experiment now will complete the data set-up obtained during the MARS500 study on how these respective individuals will re-act to highly physically and emotionally challenging situations during a parabolic flight.

This add-on experiment to MARS500 will enable answering to the following questions i) if the stress response systems - when compared for two conditions but in the same individuals - do react uniformly and ii) if those subjects prone to have adequate stress response pattern will show gradually less immune modulation effects.

The understanding of the complex interactions of stress and immunity under chronic and acute stress conditions might help to enable adequate health and immune monitoring and might as well suggest suitable countermeasures for the prevention of the unwanted immunological effects during long-term confinement and space missions.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers (men or women)
* Aged from 18 to 65
* Affiliated to a Social Security system and, for non-French resident, holding a European Health Insurance Card (EHIC)
* Who accepted to take part in the study
* Who have given their written stated consent
* Who participated in the MARS500 experiment
* Who has passed a medical examination similar to a standard aviation medical examination for private pilot aptitude. There will be no additional test performed for subject selection.

Exclusion Criteria:

* Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated
* Pregnant women
Personality Traits and Exercise Addiction in Ultra Endurance Athletes

Ultra endurance sports (events exceeding 6 hours) is becoming increasingly popular and Exercise Addiction (EA) is frequent in this type of sports, which are characterized by very high training volume. However, little is known about the personality traits of athletes who are more likely to develop EA. This study aims to assess the personality traits associated with EA in ultra endurance athletes. We designed a cross sectional study. Participants have to fill a web-based questionnaire including the Big Five Personality Test for assessing the personality traits and the Exercise Dependence Scale-Revised (EDS-R) for assessing EA. Also they have to fill a personal question about demographics (age, gender, work), sport practice and eating habits. A minimum sample size of 300 participants is expected. Statistical analyses will test the association between personality traits and the presence (or absence) of EA according to the EDS-R. Secondary analysis will test the association between the type of sport (running, cycling, triathlon, swimming), the volume of sport practice and the presence of eating disorders and EA.


Eligibility Criteria:
Inclusion Criteria:

* athletes participating in ultra endurance sport events (exceeding 6 hours) in running/trail, cycling, swimming, Nordic skiing
* individuals who volunteered to participate in the study
* individuals with access to internet
* Individuals reading French

Exclusion Criteria:

* individuals not meeting the inclusion criterias
* individuals who did not participate in an ultra endurance event in the previous year
Organ Failure After Advanced Endovascular Thoracoabdominal Aortic Surgery

The purpose of this study is to investigate the mortality and frequency of organ dysfunction in patients after endovascular thoracoabdominal aortic surgery, and to search for biomarkers of organ dysfunction, in particular the spinal cord, the kidneys and the gastrointestinal tract. All adult patients undergoing endovascular thoracoabdominal aortic surgery at Örebro University Hospital, Örebro, Sweden, are asked for participation in this study. All participating patients sign informed consent at the inclusion. During the operation and during the postoperative intensive care, the function of the spinal cord, the gastrointestinal tract and the kidneys are collected along with other clinical parameters. Plasma blood samples, urin samples and cerebrospinal fluid samples are collected from each patient during the operation and during the postoperative care at the intensive care unit. During the operation two microdialysis catheters are placed in the abdomen, and the samples are continuously collected and analyzed. The biomaterial samples are stored in a biobank for later determination of proteins and other molecules. Postoperative survival and the frequency of complications are analysed.


Eligibility Criteria:
Inclusion Criteria:

* Accepted for endovascular advanced thoracoabdominal aortic surgical procedure
* Adult

Exclusion Criteria:

* Pregnant
The Role of Igf-1 Generation Test in Diagnosis and Treatment of Short Stature

The purpose of the study is to evaluate the predictive value of IGF-1 generation test for growth velocity during GH treatment for 12 months.


Eligibility Criteria:
Inclusion Criteria:

* ability to provide written informed consent
* Prepubertal males and females form 5- 11years old
* Bone age \<11 years in males and \<9 years in females
* Height SD score\<-2.25SD in males and females
* IGF-1SD score \<-1SD in both males and females
* Peak GH level after stimulation \>10ng/ml

Exclusion Criteria:

* History of prior chemotherapy and or radiation
* Active neoplasm
* Pediatric patients with closed epiphyses
* Prader-Willi syndrome, Turner syndrome or any other genetic or chromosomal anomaly
* Treatment with inhaled or systemic steroids
* BMI \<5th percentile or \>95th percentile
* Tanner 2 at clinical or biochemical examination by ultrasensitive LH and FSH
Study of Gemcitabine and Herceptin Versus Xeloda and Herceptin in HER-2 (+) Metastatic Breast Cancer Patients

The optimal treatment for pretreated patients with metastatic breast cancer has not been established. Gemcitabine and capecitabine are two active agents in this setting. For women with Her-2 positive breast cancer, combinations of either gemcitabine or capecitabine (Xeloda) plus Herceptin has been proved active and well tolerated.

This trial compares the efficacy of the combinations gemcitabine plus Herceptin versus capecitabine (Xeloda) plus Herceptin in pretreated patients with metastatic HER-2 positive breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Histologically confirmed metastatic breast adenocarcinoma (stage IV) without any prior chemotherapy received
* HER-2 overexpression 2+ or 3+ using IHC or FISH +
* Measurable disease
* At least one prior chemotherapy regimen
* Not in a prior irradiation field
* No patients with brain metastatic disease who has not been irradiated or uncontrolled brain metastatic disease after irradiation
* No more than 25% of myeloproductive bone marrow irradiated. More than 4 weeks since prior radiotherapy and recovered
* Age 18 - 75 year old
* Performance status (WHO) 0-2
* Life expectancy more than 12 weeks
* Absolute neutrophil count \> 1500/mm\^3, platelet count \> 100000/mm\^3, hemoglobin \> 9 gr/mm\^3)
* Adequate liver (bilirubin \< 2 mg/dL, SGOT/SGPT \< 2 times upper limit of normal, ALP \< 3 times upper limit of normal, creatinine \< 1.5 upper limit of normal
* Adequate cardiac function (LVEF \> 50%)

Exclusion Criteria:

* Pregnant or nursing
* Positive pregnancy test
* Concurrent agents ketoconazole, macrolide antibiotics, zidovudine which may induce P-450 cytochrome
* Motor or sensory neuropathy \> grade 1 according to NCIC toxicity criteria
* History of allergic reaction attributed to docetaxel
* Psychiatric illness or social situation that would preclude study compliance
* Other concurrent uncontrolled illness
* Other invasive malignancy within the past 5 years except cured basal cell skin carcinoma and cervical carcinoma in situ