cyrilzakka/clinical-trials huggingface dataset:
The Characterization of Blood Volumes of Commercially Available Lancing Devices

Characterize expressed blood volume ≥1μL across representative, commercially available lancing device systems using finger sticks.

Primary Objective:

• Characterize expressed blood volume ≥1μL across representative, commercially available lancing device systems using finger sticks.

Secondary Objectives: the following characterizations will be performed in the data analysis within each device and across each device:

* Correlation of Subject pain response to blood volume collected;
* Proportion of Subjects that produce sufficient blood to fill a 1µl test strip;
* Proportion of Subjects that generate ≥1µl blood volume;
* Proportion of Subjects who generate multiple- times the blood volume needed to fill a 1µl test strip
* Proportion of Subjects who generate multiple- times ≥1µl of blood volume
* Proportion of Subjects that produce on average (≥1µl) of blood volume on 1st attempt
* Proportion of Subjects that produce on average (≥1µl) of blood volume on their first and second lancing attempt

Eligibility Criteria:
Inclusion Criteria:

* Must be diagnosed with type 1 or type 2 diabetes for one (1) or more year(s).
* Must be currently self-monitoring blood glucose levels for at least 6 months.
* Must self-test at least 2 times daily.
* Must be between the ages of 18 and 75 to participate.
* Subjects must be able to perform all tasks required in this protocol.
* Subjects must be willing to complete all study procedures.
* Subjects must be able to speak, read and understand English and understand the Informed Consent document.

Exclusion Criteria:

* Subjects with neuropathy or any other nerve damage in the hand or fingers (this will be discovered through the monofilament test)
* Subjects who are taking prescription anti-coagulants or more than one full aspirin per day during the past week or have clotting problems that may prolong bleeding (persons taking Plavix or a daily low dose aspirin will not be excluded but this will be recorded).
* Subjects taking pain relievers within 24 hours.
* Subjects with hemophilia or any other bleeding disorder.
* Subjects with infection with a blood borne pathogen (e.g., HIV, hepatitis).
* Subjects having a condition such as a cognitive disorder, which in the opinion of the Investigator would put the person at risk or seriously compromise the integrity of the study (PI will sign Case Report Form if Subject is excluded).
* Subjects working for Facet, LifeScan Inc., or a competitive company.
* Subjects with missing digits.
* Subjects who are pregnant or nursing.
* Subjects on chemotherapy.
Combining RT With Immunotherapy and Chemotherapy in Metastatic Nasopharyngeal Carcinoma

Incidences of de novo metastatic nasopharyngeal carcinoma range from 6% to 8% at the time of presentation. For the initial diagnosis of metastatic NPC, PD-1 plus chemotherapy yields a satisfactory outcome with1year PFS of 40%. Previous study demonstrated the benefit of adding radiotherapy to chemotherapy in metastatic NPC, however there is no evidence whether radiotherapy can further improve PFS based on chemotherapy plus PD-1 . The purpose of this study is to evaluate the safety and effectiveness of first-line immunochemotherapy combined with radiotherapy for initial diagnosed metastatic NPC.


Eligibility Criteria:
Inclusion Criteria:

* Age:18-75 years, male or female.
* ECOG 0-2
* Histologically or cytologically confirmed de novo metastatic nasopharyngeal carcinoma.(stage IVb, AJCC 8th)
* Complete response or partial response after at least 3 cycles (no more than 6 cycles) of chemotherapy combined with immunotherapy
* Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
* Adequate organ function.
* Patient has given written informed consent.

Exclusion Criteria:

* Unwilling or unable to provide informed consent
* Intolerance to radiotherapy or immunotherapy
* Patients who have head and neck radiotherapy history.
* previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ
* women in pregnancy, lactation period, or no pregnancy test 14 days before the first dose
* in other clinical trials within 30 days
* Patients with autoimmune disorder, including but not limited to systemic lupus erythematosus or multiple sclerosis;
* History of primary immunodeficiency
* History of active tuberculosis, drug-induced interstitial lung disease, or ≥ Grade 2 pulmonitis;
* Patients with human immunodeficiency virus (HIV) positive;
* Comorbidities that cannot be controlled by concomitant treatment, including but not limited to: ongoing or active infection, unexplained fever \> 38.5°C (subjects with neoplastic fever are judged by the investigator to be included), symptomatic congestive heart failure ≥ Grade 2 according to New York Heart Association (NYHA) functional classification, LVEF (left ventricular ejection fraction) \< 50%, hypertension poorly controlled by drugs, unstable angina, arrhythmia, active peptic ulcer disease or gastritis;
* not suitable for this study judged by researchers
Humanized CAR-T Therapy for Treatment of B Cell Malignancy

The present study evaluates the safety and efficacy of humanized Chimeric antigen receptor T cells (CAR-T) in treating recurrent or refractory B cell malignancy targeting CD19 with a humanized scFv. All participants will receive autologous chimeric antigen receptor engineered T cells.

CD19 has been extensively evaluated as a therapeutic target for recurrent or refractory B cell malignancy by chimeric antigen receptor T cell therapy, the single chain antibody sequence (scFv) against CD19 derived from a mouse hybridoma was widely employed. However, the immunogenicity of the mouse scFv sequence might be one of the reasons that CAR-T cells cannot persist in vivo for long. In present study investigators replace the mouse-derived scFv with a a humanized one and evaluate its safety and efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Age≥3 at the time of consent
* Survival time\>12 weeks
* B cell hematological malignancies by pathological examination
* Chemotherapy failure or recurrent B cell malignancy
* Creatinine\< 2.5mg/dl
* Glutamic-pyruvic transaminase, glutamic oxalacetic transaminase\< 3 fold of normal level
* Karnofsky Performance Status\>50% at the time of screening
* Bilirubin\<2.0mg/dl
* Adequate pulmonary, renal, hepatic, and cardiac function
* Fail in autologous or allogenic haemopoietic stem cell transplantation
* Free of leukocytes removal contraindications

Exclusion Criteria:

* Pregnant or nursing women
* Active hepatitis B, active hepatitis C, or any human immunodeficiency virus (HIV) infection at the time of screening
* Previous treatment with any gene therapy product
* Abnormal vital signs
* Highly allergic constitution or history of severe allergies, especially allergy to interleukin-2
* General infection or local severe infection, or other infection that is not controlled
* Dysfunction in lung, heart, kidney and brain.
* Severe autoimmune diseases
* other symptoms that are not applicable for CAR-T
Exercise in Patients Admitted With Recently Decompensated Heart Failure

An aerobic physical exercise protocol will be applied to patients admitted in ward due to decompensated heart failure, in order to validate the efficacy and safety of physical exercise in this phase of clinical stabilization, through the said training protocol - ERIC program.

With the objective of validating the efficacy and safety of physical exercise as a therapeutic resource in patients admitted for decompensated heart failure; will be applied, by rehabilitation nurses, a protocol of physical exercise, with increasing levels of intensity. Patients who meet the inclusion criteria will be randomized through an online program (randomizer.org) and the ERIC protocol will be applied to the test group. The control group will be implemented the usual care of rehabilitation nursing. The ERIC protocol comprises 5 levels of intensity, as following shown: Stage 1 - respiratory and calisthenic exercises (5-10 minutes) Stage 2 - pedal for 5-10 minutes Stage 3 - aerobic training: walking on the corridor for 5-10 minutes Stage 4 - aerobic training: walking on the corridor for 10-15 minutes Stage 5 - aerobic training: walking on the corridor for 15 minutes + climbing stairs for 5 minutes All patients will be monitored and followed up by a rehabilitation nurse while they are doing the exercise. The investigator decides, depending on the patient's performance and clinical conditions, the form of progression in the program, but it is mandatory to follow the previously defined levels of intensity.

Patients in the test group may start the program only on stage I or II according to clinical criteria. At admission of the patients (test group and control group) clinical and sociodemographic parameters are evaluated, as well as data related to Barthel's indices and London Chest of activities of daily living (LCADL). At the discharge date, the Barthel index and the LCADL scale will also be evaluated, as well as the 6-minute walking test.

Eligibility Criteria:
Inclusion Criteria:

* Admission diagnosis of Decompensated heart failure
* More than 18 years old
* Capacity to provide informed consent

Exclusion Criteria:

* Osteoarticular pathology that impedes the performance of the exercise
* Existence of inotropic infusions
* Dysrhythmia or precordial pain in the last 24 hours
* Acute pulmonary edema in the last 12 hours
* Systolic blood pressure greater than 180millimetre of mercury (mmHg) or less than 80mmHg (except in cases where this is the baseline value for the patient)
* Need for oxygen at a rate greater than 3 /min
* Glycemic decompensation in the last 12 hours
A Trial to Determine Weight Gain Benefits of Caloric Supplementation for NAS Infants

A randomized clinical study in NAS infants managed via the Eat, Sleep, Console (ESC) approach comparing early weight loss on a standard-caloric density versus high-caloric density feeding regimen.

The aims of the study is to systematically evaluate the benefit of high-caloric diet regimens given to NAS infants in the first three weeks of life. Breastfeeding is the preferred feeding method for NAS infants as it has shown to reduce NAS severity and infant weight loss, though women who are not adherent to drug treatment programs or have the potential to use illicit drugs are not able to breastfeed due to the risks posed to the infant. Several studies have demonstrated the potential for caloric enhancement of formula and breast milk to support weight gain in NAS infants. Through a randomized control trial analyzing infant weight gain on standard-calorie vs. high-calorie diet regimens, we aim to quantify weight patterns in NAS infants and show that increasing caloric intake can improve weight gain.

Eligibility Criteria:
Infant Inclusion Criteria:

* Infants with NAS born to mothers age 18-45 with methadone exposure before or during pregnancy who do not intend to place their infants for adoption
* Infants \> 2200 g Infants at least 36 weeks gestational age
* Delivered at: Yale New Haven Hospital
* Mothers/infants able to return to outpatient pediatric provider for 2 month and 4 month weights visits

Infant Exclusion Criteria:

* Infants with major congenital malformations
* Infants enrolled to NICU \>24 hours for medical conditions other than NAS treatment before 3 days of life

Mother's Inclusion criteria -

* Pregnant women (age 18-45) who have started methadone treatment at obstetrics or other YNHH appointments
* Confirm methadone treatment is received from a licensed treatment program
* Confirm that mothers are planning to deliver their infant(s) at Yale New Haven Hospital
* Confirm that mothers do not intend to place the infant(s) for adoption
* Confirm mother's willingness to participate in the study (including attending the 2-month and 4-month follow up weigh-ins with pediatrician)
* Consent forms will be signed and faxed to study staff
Effect of Red Raspberry Consumption on Fasting Oxidative Stress Biomarkers

The purpose of this study is determine whether daily consumption of frozen red raspberries can improve the antioxidant capacity of the blood and reduce the effects of oxidative stress, dose-dependently, in a healthy adult population.

Red raspberries are an excellent source of numerous polyphenolic antioxidants. The bioactivity of these compounds have been implicated in many biological pathways and may function to reduce the risk of numerous chronic diseases. We are conducting an intervention study with frozen red raspberries on a healthy adult population in order to determine if raspberry polyphenols are bioavailable and bioactive in vivo. Twenty-four subjects (12 male and 12 female) will be recruited to participate and consume one-cup frozen red raspberries daily for two weeks, they then will randomly be assigned to consume either one, two or four cups of raspberries for another two weeks, this will be followed by four weeks of non-treatment. Blood samples and 12-hour urine collections will be taken in order to measure the concentration of raspberry polyphenols in response to treatment dose. Dose-dependent treatment effects on blood biomarkers for antioxidant capacity, oxidative stress, inflammation and other chronic disease risk factors will also be measured.

Eligibility Criteria:
Inclusion Criteria:

* healthy adults

Exclusion Criteria:

* obese (\>30kg/m2)
* high blood pressure (140/90mmHg)
* allergic to raspberries
* pregnant or lactating
* history of chronic disease
* currently taking medication
Tau PET Imaging With 18F-T807(AV1451) in Neurodegenerative Disorders

Alzheimer's disease, Parkinson's disease, and Huntington's disease are common neurodegenerative diseases. Tau is a microtubule-associated protein, and aggregated tau resulting from hyperphosphorylation is a pathological feature of a group of neurodegenerative diseases known as tauopathies. The 18F-T807 (AV1451) molecular probe is a novel molecularly targeted imaging agent that exhibits high affinity and good selectivity for tau.

In this study, 18F-T807 (AV1451) molecular probe PET/CT was used to monitor the regional distribution and the degree of deposition in patients with neurodegenerative diseases, and compared with clinical symptoms to evaluate its value in the early differential diagnosis of neurodegenerative diseases.

Eligibility Criteria:
Inclusion Criteria:

* Patients or their families complain of significant memory impairment;
* Objective memory impairment (e.g., tests of article identification, recall, delayed memory);
* Be able to obtain complete diagnosis and treatment records and be able to carry out long-term follow-up;
* Signed written consent.

Exclusion Criteria:

* Psychiatric disorders: including anxiety disorder, affective disorder, severe psychosis, or drug-induced psychosis;
* Pregnancy or lactation.
Osteoarthritis Relationships and Tobacco " Ancillary Study Khoala "

The role of tobacco in osteoarthritis remains controversial. The Khoala cohort is the first multicenter French cohort of subjects with knee and / or hip osteoarthritis prevalent . It guarantees its methodology great representativeness and therefore an interesting material for the study of risk factors in the population. In addition, it should have little here Radiographs of hands for all its patients. It therefore has the opportunity to study a possible relationship between tobacco and hip osteoarthritis , knee and hand but also to study the relationship between tobacco and structural evolution of hip osteoarthritis and / or symptomatic knee.


Eligibility Criteria:
Inclusion Criteria:

* Men or women aged between 40 and 75 years
* hip osteoarthritis and / or knee ( stifle ) , unilateral or bilateral , symptomatic with a confirmed diagnosis and meeting the ACR criteria , representative of prevalent cases in France during the constitution of the cohort
* Affiliation to social security

Exclusion Criteria:

* Presence of a hip or knee prosthesis of the painful joint at baseline ;
* Antecedent osteotomy ;
* severe comorbidity likely to affect significantly the quality of life or induce a major healthcare consumption regardless of osteoarthritis ;
* Knee pain with patellofemoral osteoarthritis isolated , that is to say without tibiofemoral osteoarthritis associated ;
* Other pathologies of these joints
* adults subject to a legal protection measure or unable to express their opposition not to participate in the study
A Medical Device to Treat Wide-Neck Brain Aneurysms

The study aims to evaluate the safety and probable benefit of a medical device to treat wide-neck ruptured brain aneurysms.

Patients with ruptured brain aneurysms will be treated with the Nautilus, then will be followed up for one year.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is ≥18 years old
2. Subject who presents with an angiographically confirmed, wide neck intracranial saccular, acutely ruptured aneurysm. Wide neck is defined as 4-7mm.
3. Aneurysm dome ≥5 mm.
4. Subject is neurologically stable with a Hunt \& Hess score of I, II, or III.
5. In the opinion of the treating physician, placement of the Nautilus is technically feasible and clinically reasonable.
6. The subject or authorized representative is able to provide informed consent and has signed the IRB-approved informed consent form.
7. Subject must be able to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule.

Exclusion Criteria:

1. Subject with any neurological deficit occurred within the last 180 days; defined as previous non-aneurysmal subarachnoid hemorrhage or any other non-aneurysmal intracranial hemorrhage, stroke, transient ischemic attacks (TIA), concussion, head trauma, cranial surgery, radiation therapy to the head.
2. Premorbid mRS score ≥3.
3. Subject has another aneurysm which, in the Investigator's opinion, will require treatment within the follow-up period (1 year).
4. Women of child-bearing potential age (18-55) who cannot provide a negative pregnancy test.
5. Subject with other serious comorbidities that carry a high risk of neurologic events such as:

   * Significant acute or chronic cardiovascular disease such as myocardial infarction within the past 180 days
   * Uncorrectable coagulation abnormality
   * Uncontrolled diabetes mellitus with target organ injury
   * Organ failure of kidney, liver, heart or lungs
   * Arteriovenous malformation or arteriovenous fistula, Moyamoya disease, or any other vasoconstriction
   * Premorbid intracranial tumor or hematoma
6. Severe or unstable conditions or diseases (e.g., non-significant neurological deficit, cancer, hematologic or coronary disease) or chronic conditions that in the opinion of the investigator may increase the risk associated with study participation for study device administration or may interfere with the interpretation of study results.
7. Extreme vessel stenosis or tortuosity or other vascular anomalies that would prevent delivery of the device to the target.
8. Comorbidities that may preclude obtaining follow-up DSA.
9. Known allergy to Nickel and/or Heparin that cannot be medically treated.
10. Subject is currently participating in another interventional clinical study.
11. Subject with a relative contraindication to angiography (i.e., allergy to contrast media, coagulopathy, etc.)
Impacts of Fruit on the Gut Health and Human Health

The objectives of this study are to investigate the effect of fruit consumption on the gut microbiota and their collective fecal and plasma metabolomes, vascular and cardiometabolic functions, cognition, and motor control.

The Investigators findings will provide data critical to the understanding of the effects of fruit intake on the gut microbiome and the capacity of the microbiota to biotransform nutrients contained within fruits as well as the subsequent impact on circulating status of those metabolites. Concurrently, health outcomes that may be linked to these changes including cognition, motor control, vascular function and cardiometabolic health risk markers will be assessed in healthy adults.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women 30 to 70 years old

Exclusion Criteria:

* History of:

  * stroke or myocardial infarction
  * gastrointestinal disorders
  * neurological disorders (epilepsy, multiple sclerosis, Parkinson's disease, stroke, etc)
  * known metabolic disorders (liver, renal or clinically diagnosed diabetes)
  * drug treatment for lipid reduction or hypertension,
  * psychiatric medication use
Neck Motion and Motor Control in Chronic Neck Pain and Associations With Clinical Symptoms

The primary purpose of this study is to investigate if there is altered motor control of head and neck in chronic neck pain patients compared with healthy persons. In addition, associations between neck pain, motor control, disability and function, and clinical symptoms will be studied in patients following physiotherapy treatment in primary health care.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic neck pain with duration \>2 weeks
* Normal or corrected vision
* Pain at or above 3 on Numeric Rating Scale, with "low pain" defined as 3-4 and "high pain" as 5 or higher.

Exclusion Criteria:

* Systemic or diagnosed chronic disease, including diabetes, stroke and neurological diseases, that may influence motor control and neck pain or ability to perform tests
* positive spurling test for neurological radiating arm pain
* pregnancy
* whiplash
* insufficient comprehension of Norwegian language
Maternal alpha1 Antitrypsin as a Marker of Intrauterine Growth Restriction in Pre-eclamptic Women

Intrauterine growth restriction (IUGR) is defined as a velocity of fetal growth less than the normal fetus growth potential for a specific neonate as per the race and gender. These neonates face many acute problems during peripartum and after birth .The causes of IUGR may be maternal, placental, fetal or genetic and also due to combination of any of these factors. Knowledge of etiologies of fetal growth restriction (FGR) is essential, so that future care can be targeted at prevention . It is apparent that FGR is primarily caused by placental dysfunction (PIH\&PE), insufficiency that lead to reduced fetal growth overall. FGR is associated with lifelong burden of chronic diseases including metabolic, respiratory, cardiovascular and neurological deficits. Pre-eclampsia (PE) is diagnosed by the combined presentation of high blood pressure and proteinuria. New definitions also include maternal organ dysfunction, such as renal, liver, neurological or haematological complications, uteroplacental dysfunction, or FGR . In an attempt to correct fetus reduced supply the placenta release various cytokines and markers as Alpha-1 anti-trypsin (AAT). The Golgi apparatus secretes this cytokine in placental cytotrophoblast and blood vessels. AAT is antinflammatory antiprotease protective molecule. AAT rises during normal pregnancy. The suboptimal rise of AAT in pregnancy are liable for increased obstetrical complications like abortion, preterm labor. AAT levels were found decreased in placenta tissues from women with PE compared that of healthy women. Although AAT deficiency is associated with several pregnancy and placental disorders, little is known regarding AAT levels and PE .


Eligibility Criteria:
Inclusion Criteria:

* Pregnant Pre-eclamptic women with IUGR at 32-36 weeks
* Pregnant Pre-eclamptic women with healthy fetus at 32-36 weeks
* Normal pregnant women with healthy fetus

Exclusion Criteria:

* Multiple pregnancy.
* Congenital fetal anomalies.
* Pregnant women with personal history of chronic hypertension.
* Pregnant women with renal failure.
* Pregnant women with cardiovascular disease.
* Pregnant women with diabetes mellitus.