cyrilzakka/clinical-trials huggingface dataset:
Sensitivity Study of Diagnostic for Early Detection of Dengue Infection

This study is a multi-site trial assessing the sensitivity of DENV Detect™ NS1 ELISA versus standard reference tests (e.g. PCR or viral culture) for dengue diagnosis in the US and internationally.

The DENV Detect™ NS1 ELISA serves as an aid in the clinical laboratory diagnosis of early stages of Dengue infection in patients with clinical symptoms consistent with Dengue infection. This test is intended to be used on sera obtained within the first 7 days of symptoms. DENV Detect™ NS1 ELISA results (positive or negative) must be confirmed by testing with a reference standard test.

Subjects will be patients who present with symptoms consistent with dengue infection, such as fever and myalgia. After informed consent is obtained and the subject is screened for eligibility, 2 diagnostic samples will be collected. The first will be collected within the first 7 days of symptoms onset, and the second will be collected at least 7 days later, between the 10th and 21st days post-onset of symptoms.

ELISA and reference tests will be performed by different operators who are laboratory staff members. These staff members, blinded to each other's results, will evaluate the samples from each method independently.


Eligibility Criteria:
Inclusion Criteria:

* All age groups and both sexes.
* Initial serum samples must be collected within 1- 7 days of onset of symptoms consistent with Dengue virus infection.
* Information must be available about symptoms, age, and sex of patient from which samples are collected.
* The location of sample collection must be recorded.
* Archived samples that have been sent to reference labs for dengue or flavivirus testing should be considered for inclusion as test specimens in this study. If these specimens are included in this study, then they must have a documented history that the specimen was obtained within the first 7 days of onset of subject symptoms consistent with dengue infection.

Exclusion Criteria:

* Archived samples with linked personal identifiers or any sample for which personal information can be discovered.
* Prospective samples from nursing home residents; inmates/subjects in police custody; participants who are unable to understand verbal or written local language in which a certified translation of the informed consent is available, or requires a Legal Authorized Representative (LAR) for consent.
* Subject serum specimens that have undergone more than 2 freeze-thaw cycles or that have not been stored frozen.
Evaluation of Responses to Fluzone® in Infants ≥ 6 Months of Age Who Did or Did Not Receive Fluzone® at 2 Months of Age

The study is to compare the 2 Groups with respect to antibody responses to inactivated influenza vaccine.

Observational Objectives:

* To describe the percentage of participants with protective Hemagglutinin (HAI) antibody titers to each of the 3 vaccine antigens in both study groups following each vaccination.
* To describe the HAI geometric mean titer (GMTs) to each of the 3 vaccine antigens in both study groups following each vaccination.
* To describe the safety of the 2005-2006 pediatric formulation of Fluzone® vaccine in both study groups.

This is a descriptive study that will provide preliminary comparative information about the safety and immunogenicity of Fluzone® vaccine among children who were given Fluzone® vaccine at 2 months of age (Study GRC27 NCT00858468)and those who never received influenza vaccine.

Eligibility Criteria:
Inclusion Criteria:

* Participant is between 6 and 10 months of age on the day of inclusion (has reached 6-month but has not reached 11-month anniversary of birth).
* Available for the duration of the study.
* Born at full term of pregnancy (≥ 36 weeks) with a birth weight ≥ 2.5 kg
* Parent/legal acceptable representative willing and able to provide informed consent.
* Parent/legal acceptable representative able to attend all scheduled visits and comply with all trial procedures.
* Parent/legal acceptable representative willing to permit venipuncture for purposes of collecting a blood sample.
* Previously enrolled in the 2-month-old group in Study GRC27 or approved by sponsor for enrollment as control.

Exclusion Criteria:

* Reported allergy to egg proteins, chicken proteins, or any other constituent of Fluzone vacccine.
* Previous history of influenza vaccination (Group 2 subjects only).
* Receipt of any vaccine in the 14 days prior to enrollment.
* An acute illness with or without fever (rectal temperature ≥ 38.0 °C \[or ≥100.4 °F\]) in the 72 hours preceding enrollment in the trial.
* Known bleeding disorder.
* Participation in any other interventional (e.g., vaccine, drug) clinical trial (except Study GRC27) within 30 days prior to enrollment, or planned participation in another interventional clinical trial prior to termination of the subject's participation in this study.
* Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth.
* Personal or immediate family history of congenital immune deficiency.
* Developmental delay, neurologic disorder, or seizure disorder.
* Chronic medical, congenital or developmental disorder that could interfere with trial conduct or completion.
* Known human immunodeficiency virus (HIV)-positive or hepatitis B surface antigen (HBsAg)-positive mother.
* Known HIV, hepatitis B, or hepatitis C infection.
* Receipt of blood or blood-derived products within the past 2 months.
* Prior history of Guillain-Barré syndrome.
* Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
Study MK0767 and Metformin in Type 2 Diabetic Patients (0767-020)

The purpose of the study is to assess how MK0767, compared to Metformin, performs in lowering blood glucose levels in patients whose Type II diabetes is not controlled by diet and exercise.


Eligibility Criteria:
Inclusion Criteria:

* Patients are men and non-pregnant women ages 21 to 78 years
* Patients either not on antihyperglycemic medications (\>8 weeks), or being treated with a single oral antihyperglycemic agent \& willing to discontinue therapy for the duration of the study

Exclusion Criteria:

* Patient has history of type 1 diabetes mellitus and or history of ketoacidosis
* Patients undergoing surgery within 30 days of Visit 1
* Patients taking Warfin or Warfin-like anticoagulants
* Patients on a weight loss program with on-going weight loss or starting an intensive exercise program within 4 weeks of Visit 1/Week 9
Decision Making in Degenerative Lumbar Spine : CT vs. MRI

To identify the optimal imaging modality involved in decision making in patients with degenerative lumbar spine using CT vs. MRI.

* There is 266 million individuals (3.63%) worldwide have DSD and LBP each year; the highest and lowest estimated incidences were found in Europe (5.7%) and Africa (2.4%), respectively. Based on population sizes, low- and middle-income countries have 4 times as many cases as high-income countries. Thirty-nine million individuals (0.53%) worldwide were found to have Spondylolisthesis, 403 million (5.5%) individuals worldwide with symptomatic disc degeneration, and 103 million (1.41%) individuals worldwide with spinal stenosis annually.
* Degenerative disease of the lumbar spine is a significant cause of disability in the world; it encompasses conditions such as Spondylolisthesis, disc degeneration, and lumbar spinal stenosis. Associated with a variety of clinical symptoms, including lower extremity pain, weakness, and low back pain (LBP) of varying levels of severity.
* Imaging plays an important role in the evaluation of degenerative spine.
* Plain films still play an important role in evaluation of the spine, because the examination is inexpensive and available and gives a wide panoramic view of the spine. Direct information about bony structures can be obtained, and functional information about misalignment and vertebral stability can be obtained with upright dynamic films in flexion-extension and lateral bending.
* Computerized axial tomography (CAT) scan: CT scan shows soft tissues such as ligaments and muscles more clearly than traditional X-rays do, so it is more useful for diagnosing certain problems, such as ruptured or degenerated discs and spinal stenosis.
* Magnetic resonance imaging (MRI): The advantage of MRI scans over X-rays and CT scans is that MRI provides clear, detailed images of the soft-tissue structures, such as the muscles, cartilage, ligaments, discs, tendons and blood vessels, in addition to the bones.

Eligibility Criteria:
Inclusion Criteria:

* degenerative lumbar spine diseases.
* age more than 18.

Exclusion Criteria:

* Patients with contraindications for MRI.
* Patients with spinal implants in the target region.
Study to Assess the Impact on Calcium Levels When Hemodialysis Patients With Secondary Hyperparathyroidism (SHPT) Switch From Cinacalcet to Etelcalcetide

This is a multicenter, multiple-dose, single-arm, open-label study to assess the impact on serum corrected calcium levels when switching patients from cinacalcet to etelcalcetide (AMG 416).


Eligibility Criteria:
Inclusion Criteria

* Subject is 18 years of age or older at the time of informed consent.
* Subject must be receiving maintenance hemodialysis 3 times weekly for at least 8 weeks.
* Subject must have SHPT as defined by having a mean of 3 consecutive central laboratory screening predialysis serum parathyroid hormone (PTH) values ≥ 200 pg/mL, with measurements obtained from 3 different calendar weeks in the 4-week screening period while receiving cinacalcet.
* Subject must have a mean of 3 consecutive central laboratory screening predialysis serum corrected calcium (cCa) values ≥ 7.5 mg/dL, with measurements obtained from 3 different calendar weeks in the 4-week screening period while receiving cinacalcet.
* Subject must be on a stable dose of cinacalcet before screening (defined as no dose change within the 4 weeks prior to screening).
* Other Inclusion Criteria may apply.

Exclusion Criteria

* Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s).
* Subject has received AMG 416 in a prior clinical trial of AMG 416 (also known as KAI-4169).
* Subject has known sensitivity to any of the products or components of AMG 416 to be administered during dosing.
* Subject is unwilling to use effective contraception during the study, and for women, up to a period of up to 3 months after the last dose of AMG 416.
* Subject is pregnant or nursing.
* Anticipated or scheduled parathyroidectomy during the study period.
* Subject has received a parathyroidectomy within 6 months prior to dosing.
* Other Exclusion Criteria may apply.
Feasibility and Effectiveness of Distributing Micronutrient Sprinkles to Reduce Prevalence of Anemia

The objective of this study is to test the feasibility and effectiveness of distributing micronutrient sprinkles to 6-20 month old children participating in an integrated maternal and child health and nutrition program in rural Haiti. The micronutrient sprinkles have been formulated to prevent or treat anemia in 6-23 month old children. Effectiveness in reducing the prevalence of anemia will be assessed.

Anemia is highly prevalent among infants and young children in Haiti and throughout the world. Low intakes of several micronutrients contribute to this problem. It is very difficult to meet the micronutrient needs of infants and young children without substantial amounts of animal-source foods; such foods are not affordable for most families in many poor communities.

Micronutrient sprinkles are a novel approach to meeting children's needs. The sprinkles are packed in sachets containing a daily ration, and are intended to be used in the home and "sprinkled" directly on the children's food. Earlier trials have shown the efficacy of the sprinkles for preventing and treating anemia under controlled conditions.

The current study tests the feasibility and effectiveness when sprinkles are distributed in the programmatic context of a US Title II food aid distribution program, a context that is common in many countries that receive assistance from the United States Agency for International Development and other donors. The study also includes the development and dissemination of educational messages to motivate and enable caregivers to use the sprinkles properly. Based on previous efficacy trials no side-effects are anticipated, but the study also monitors for unanticipated side-effects.

Comparison: Since effectiveness of the sprinkles distributed as part of a take-home ration has not been established, this study employed a randomized controlled design. Randomization occurred at the level of the food distribution point (place where community members gather to receive food rations). Groups were assigned to receive either the take home ration (usual program practice) or the take home ration and the sprinkles. Families receiving only food rations at the control sites will receive sprinkles along with their food ration immediately after data collection is complete. The design was also consistent with the program necessity of a gradual roll-out of this new intervention. The prevalence of anemia among target-age children will be compared between groups that receive a two-month supply of micronutrient sprinkles with their take-home food ration, and those that do not.

Eligibility Criteria:
Inclusion Criteria:

* 6-20 months old at time of recruitment
* Family receives food rations at World Vision-Haiti's Food Distribution Points

Exclusion Criteria:

* Severe anemia at time of recruitment (hemoglobin \<7.0 g/dl)
A Combination Study With Ridaforolimus (MK8669) and Dalotuzumab (MK0646) in Patients With Advanced Cancer (8669-004)

This study is being done to find the best tolerated dose of ridaforolimus and dalotuzumab in patients who have advanced cancer and to observe any anti-tumor activity in these patients.

Ridaforolimus (MK8669/AP23573) was also known as deforolimus until May 2009

Eligibility Criteria:
Inclusion Criteria:

* You must have confirmed metastatic or advanced cancer that has not responded to standard therapy or where standard therapy does not exist
* In Part C, patients must have a diagnosis of advanced or metastatic colorectal adenocarcinoma or non-small cell lung cancer, and must have received at least 1 but no more than three prior systemic therapy treatment regimens
* You must be over the age of 18 years old
* You must have a ECOG status performance of 0 or 1
* You must have good organ function
* You must be willing to have skin and/or tumor biopsies

Exclusion Criteria:

* You have had cancer treatment within 4 weeks prior to entering the study or you still have bad side effects from previous therapies
* You have an active infection that requires treatment
* You are HIV positive or have a history of Hepatitis B or C
Biomarkers in Patients With Pneumonia

To identifying biomarkers in patients with pneumonia

The aim of this study is to identify the biomarkers in patients with pneumonia. These biomarkers can distinguish community-acquired pneumonia, hospital-acquired pneumonia, severe pneumonia, bacterial infection, virus infection and fungal infection. Furthermore, these biomarkers can identify the efficacy of treatment in patients with different interventions.

Eligibility Criteria:
Inclusion Criteria: Healthy patients without any diseases -

Exclusion Criteria:Age less than 18 years

-
REACH SVS Control Patient Cross-Over Study

This is a multicenter, prospective study designed to evaluate performance of the SVS in the REACH SVS control patients. The study is expected to enroll up to 20 patients at up to 12 sites with up to 6 patients per site.


Eligibility Criteria:
Inclusion Criteria:

* Patient was enrolled in the REACH SVS Study control group and has completed their participation in the Study including the 12 month follow-up visit.
* Patient has received standard-of-care medical management and it has been stable for 6 weeks.
* Patient is willing to participate in a study, complete the required follow-up visits, and maintain consistent nutrition and exercise habits during the study period.

Exclusion Criteria:

* Patient is classified as ASA Class greater than P4 including presence of co-morbidity that could significantly increase the risk of a bronchoscopy procedure.
* Patient participated in a study of an investigational drug or device within the past 30 days prior to participation in this study.
* Patient has demonstrated unwillingness or inability to complete baseline data collection procedures.
* Patient has co-existing major medical disease that will limit evaluation, participation, or follow-up in the study.
* Patient is unable to provide informed consent.
* Patient is not an appropriate candidate for or is unable to tolerate, flexible bronchoscopy procedures.
* Patient has history of 4 or more hospitalizations for COPD exacerbation or respiratory infections in the past year and none have occurred in the prior 3 months.
* Patient has evidence of systemic disease or neoplasia expected to compromise survival during the 3-month study period
* Patient has demonstrated unwillingness or inability to complete screening or baseline data collection procedures.
Human Aging and in Vivo Noradrenergic System

The main goal of this research proposal is to provide, for the first time in humans, a wider understanding of the role of the noradrenergic system both in health and illness (Parkinson's disease) through the use of a newly developed radiotracer (11Carbon \[11C\]Yohimbine) visualizing alpha-2 (α2) adrenergic receptors (AR) combined with cutting-edge technology, the hybrid positron emission tomography (PET)/magnetic resonance imaging (MRI) scanner. The secondary aim of this study will be to determine whether the expected age- and Parkinson's disease (PD)-related changes in the noradrenergic system are paralleled by changes in neuropsychological performances (such as cognitive, motor and/or olfactory abilities).


Eligibility Criteria:
Inclusion Criteria for the healthy controls:

* Age between 20 years and 80 years
* Weight between 40 kilograms (kg) and 95kg
* Without neurologic or psychiatric history
* Without head trauma history including loss of consciousness superior to 30 minutes.
* Affiliated to a social security or similar scheme
* Not subject to any legal protection measures
* Participant must have signed an informed consent document indicating that they understand the purpose of, and procedures required for, the study and are willing to participate in the study and comply with the study procedures and restrictions

Inclusion Criteria for the patients with Parkinson's disease:

* Age between 40 and 80 years old
* Weight between 40 kilograms (kg) and 95kg
* With an idiopathic Parkinson's disease (Dopa-sensitive)
* Without head trauma history including loss of consciousness superior to 30 minutes.
* Affiliated to a social security or similar scheme
* Not subject to any legal protection measures
* Participant must have signed an informed consent document indicating that they understand the purpose of, and procedures required for, the study and are willing to participate in the study and comply with the study procedures and restrictions

Exclusion Criteria:

* Subject with alcohol or substance abuse history
* Subject with somatic drug therapies
* Magnetic Resonance Imaging (MRI) contraindications (implanted or embedded metal objects in the head or body)
* Positron Emission Tomography (PET) contraindications
* Exposed to 1 millisievert or more of ionizing radiation in the year before the start of this study
* Subject unable to sign written consent for participation in the study
Interferon-pegyle α2a Efficiency and Tolerance in Myelofibrosis

Patients who carried primary or secondary myelofibrosis from Philadelphia negative MPNs (PMF/SMF) and who are treated or are about to be treated with pegylated-interferon (mostly α2a) are eligible to this prospective study. Biological and clinical parameters will be collected from the beginning of the drug use until last news.

A non-opposition consent form need to be signed before entering this study.

In all centres interested, patients who were diagnosed for PMF/SMF can be treated with oral or sub-cutaneous drugs in order to reduce clinical symptoms and biological abnormalities belonging to these diseases.

Pegylated-interferon is one of the better weapons that can be used in these cases. These treatments are well known and used from many years in french hematological centres.

The investigators to collect clinical and biological data from patients treated with pegylated-interferon α2a (the most use) in case of PMF/SMF in order to assess efficacity and tolerance to this drug. The prescription of the product and the dose are under the responsibility of each practician.

Clinical data collected: disease and patients characteristics at the time of diagnosis and at the beginning of the drug use, spleen and liver size, presence of constitutive symptoms, transfusion needs.

Biological data collected: complete hemogram, CD34+ cells count, allele burden of JAK2V617F and calreticulin clones if DNA samples are collected.

These data will be collected avery 3 months during the two first years and every 6 months after.

The investigators also recorded adverse side effects if significative, the concomitant use of hematological drugs (cytoreductive treatments, ASE...), modalities of prescription of the drugs and the reason for stopping the drug and etiology of death if happened.

Eligibility Criteria:
Inclusion Criteria:

* Primary or secondary Myelofibrosis
* Prescription of pegylated interferon α2a
* Age \> 18 years-old

Exclusion Criteria:

* Other MPNs treated with pegylated interferon α2a
* Patients treated for PMF or SMF but without pegylated interferon
A Study to Determine the Effectiveness of Utilizing Intraperitoneal Bupivacaine

The purpose of this research is to determine if spraying a local anesthetic to the cecum after a laparoscopic appendectomy decreases the amount of narcotics (pain medicine) needed after surgery and reduces the time to discharge from the hospital.

The purpose of this study is to determine the effectiveness of using intraperitoneal anesthetic during appendectomy. Subjects will be randomized to receive either 20 mL 0.5% bupivicaine or 20 mL of normal saline (placebo) instilled in the right lower quadrant at the cecum after appendix has been removed. Narcotic consumption will be tracked postoperatively. Hypothesis is that instilling local anesthetic at the cecum during a laparoscopic appendectomy will decrease the amount of narcotic a patient uses postoperatively. Secondarily, this study will attempt to determine if there is a decrease in length of stay for the subjects randomized to the anesthetic infiltration.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age and older
* Laparoscopic appendectomy at Metro Health Hospital

Exclusion Criteria:

* Adults unable to consent Non-English speaking patients
* Suspected or known malignant disease
* Patients with known allergies to the local anesthetic
* Utilizes opioid pain medicine for a chronic condition
* Elective laparoscopic appendectomy
* Known allergy or contraindication to ketorolac