cyrilzakka/clinical-trials huggingface dataset:
Longitudinal Changes in Exercise Capacity in Children and Young Adults With Sickle Cell Anemia

The purpose of this study is to use comprehensive exercise testing to examine longitudinal changes in exercise capacity over a 2 year period in children and young adults with sickle cell anemia.

Although the burden of sickle cell anemia (SCA) on affected individuals is significant, few studies have examined the influence of having SCA on such measures of physical function as exercise capacity. Moreover, the physiologic basis of poor physical functioning in children with SCA is unknown and has not been studied extensively. The purpose of this proposal is to use cardiopulmonary exercise testing (CPET) to gain a comprehensive understanding of longitudinal changes in exercise capacity, and the effect of poor exercise capacity on quality of life in children and young adults with SCA. The specific aims of this project are to: 1) Measure peak oxygen consumption (VO2), the reference standard for exercise capacity, in children and young adults with SCA classified by primary pathophysiologic contributor to their decreased exercise capacity, and 2) compare results of this exercise test with the results of previously completed exercise tests to determine longitudinal changes in exercise capacity. These aims will be performed in 60 subjects with SCA and 30 matched controls who participated in a previous study, IRB# 2009-13659; "The Physiologic Assessment of Exercise Capacity in Pediatric Sickle Cell Anemia". In a secondary analysis, we will also study the participants quality of life using a set of validated questionnaires. This study is essential because it will address several areas of exercise capacity, including the longterm effects of physiologic contributors to exercise limitation, that remain fundamental knowledge gaps in SCA.

Eligibility Criteria:
Inclusion Criteria:

1. age 8 to 21 years old; AND
2. Hb SS or S-β0 thalassemia disease, confirmed by hemoglobin analysis; AND
3. Previously participated in ClinicalTrials.gov ID: NCT01527799

Exclusion Criteria:

1. inability to perform maximal testing due to physical limitation (e.g. stroke or avascular necrosis); OR
2. history of exercise-induced syncope or arrhythmias. Subjects will wait at least 2 weeks following any vaso-occlusive pain episode and 12 weeks following any disease-related complication requiring transfusion support. Individuals on hydroxyurea will be eligible. A total of 30 controls without SCA or sickle cell trait will be matched for age, sex and race and recruited from the siblings, friends or relatives of subjects enrolled on this study
Diagnostic Accuracy of the MADx Multi Array Xplorer (MAX 45k) Automated Laboratory System and the MADx Allergy Explorer Version 2 (ALEX²) - IgE Multiplex Test for the Diagnosis of Pre-defined Groups of Specific High-priority Allergens

About 20% of the general population are affected by an allergy - with an upward trend. Quite often, allergic people do not consider their disease as serious and suffer from subsequent complications, like allergic asthma, later in their life. The sooner the allergen source is identified, the sooner the therapeutic intervention (e.g. dietary recommendations, allergen avoidance, anti-inflammatory treatment or allergen immunotherapy) can be started. Cross-reactivity may also play an important role. Therefore, a comprehensive allergy test is essential for an optimal treatment of patients.

Modern multiplex testing is an individualized diagnostic approach, which may help to identify eligible patients for allergen immunotherapy and may identify risk groups by analyzing the sIgE profile. Until now, published data on the clinical usability of multiplex allergy diagnostic test systems are often limited. Even though, available studies show a good correlation between conventionally used multiplex or singleplex assays (ISAC or ImmunoCAP) and the new multiplex assay (ALEX and ALEX²), the results are often based on small sample sizes investigating many different allergens.

Therefore, this clinical performance study is conducted to evaluate the diagnostic accuracy of the ALEX² IgE multiplex test using the Multi Array Explorer (MAX 45k, MacroArray Diagnostics) automated laboratory system in comparison to a conventional IgE singleplex test system as well as clinical symptoms and skin prick test results in a total of 826 patients. Patients with the most common inhalant allergies (e.g. grass pollen, house dust mite or cat allergy) will be included as well as patients suffering from Hymenoptera venom allergy, which is the major cause of anaphylaxis.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects with suspicion of allergy
* Written consent of the participant (and/or his/her parent or legal representative) after being informed

Exclusion Criteria:

* Oral treatment with corticosteroids (\>5mg/day)
* Treatment with antihistamines (histamine (H1) receptor blockers)
* Hematological disease (coagulation disorders, anemia)
Pharmacological Intervention in Insulin Resistance Targeting Autonomic Nerve Activity

The present study on pharmacological intervention in autonomic nervous dysregulation(parasympathetic dysfunction,) regarding insulin resistance, is a concept testing in humans tohelp identify potential new pharmacological target sites in the central nervous system.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* BMI of lean and abdominally obese men and women
* weight stable

Exclusion Criteria:

* Ongoing clinically significant diseases
* History of repeated syncope
* resting pulse\<50 or systolic blood pressure \<100
Daily Tenofovir DF to Prevent HIV Infection Among Sex Workers in Cambodia

Tenofovir disoproxil fumarate (also known as tenofovir DF or Viread) is used with other anti-HIV drugs to treat HIV infection. Taking tenofovir DF every day may also prevent HIV infection. This study will determine if taking a tenofovir DF tablet every day is safe and effective in preventing HIV infection. Participants in the study will be sex workers in Phnom Penh, Cambodia.

Cambodia has one of the highest rates of HIV infection in Southeast Asia. At the end of 2002, HIV infection rates among Cambodian sex workers ranged from 14.8% to 28.8%. Tenofovir DF is a nucleotide reverse transcriptase inhibitor (NRTI) that was licensed for the treatment of HIV-1 infection by the United States Food and Drug Administration (FDA) in October 2001. This randomized clinical trial will determine if a daily oral 300 mg dose of tenofovir DF is safe and effective in preventing HIV-1 infection. This is a collaborative study between the University of California, San Francisco, the University of New South Wales, and the Ministry of Health of Cambodia.

Nine hundred and sixty HIV uninfected female sex workers in Phnom Penh will be enrolled in the trial. Participants will be randomized to receive either 300 mg of tenofovir DF or placebo daily for 12 months. Participants will be evaluated for rates of HIV infection, adherence to the drug regimen, and changes in risk behaviors. All participants will be monitored throughout the trial for side effects and toxicity. Participants will be involved in the study for 14 months.

Eligibility Criteria:
Inclusion Criteria

* HIV uninfected
* Report receiving money or gifts for vaginal or anal sexual intercourse in the year prior to study entry
* Able to provide a street address of residence for themselves and two personal contacts who would know their whereabouts during the study period
* Normal lab values within 14 days of study entry
* Ability to understand spoken Khmer
* Willing and able to provide written informed consent

Exclusion Criteria

* Pregnant or breast-feeding
* Previously diagnosed active or serious infections
* Certain medications
* Active alcohol or drug abuse that could interfer with the study
* Previously diagnosed malignancies other than basal cell carcinoma
* Any other condition that, in the opinion of the study officials, would preclude informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
SLOW-Slower Progress of caLcificatiOn With Vitamin K2

A randomized 12-month trial will include two groups of 100 individuals aged over 50 years, with asymptomatic mild to moderate Aortic valve stenosis (AVA \> 1 cm2, Vmax \< 4 m/s). The first group of 100 individuals will serve as the intervention group that will receive 300 mcg of K2 vitamin on a daily basis, while the second group of 100 individuals will be the control group that will receive placebo on a daily basis as well. Both groups will be monitored identically in order to investigate therapeutic effects on calcification and valve stenosis progression. Correlation with Mitral annulus and ascending Aorta.Exclusion criteria: Chronic Kidney disease, Vitamin K antagonists, statins, age \< 50 y.o,prosthetic valves,Aortic Valve area (AVA) \< 1cm2 ,Vmax \> 4 m/s

For the purposes of this study, all individuals will be subjected to the same quantitative and qualitative tests, before and after the daily administration of 300mcg K2 vitamin/placebo for a period of one year.Clinical examination,extensive blood laboratory tests,direct measurement of Dephosphorylated-uncarboxylated MGP(dp-ucMGP), Echocardiogram and ECS,carotid ultrasound,ophthalmologic exam,further imaging methods with MSCT Calcium Score(Agatston score) will take place.Correlations with their medical and pharmacological therapy history.

Before and after the administration of VK2/placebo, the following measurements will take place i)Quantitative and percentile rate determination of Aortic Valve, Mitral Valve and Ascending Aorta calcification via MSCT Calcium score without contrast.

ii)Echocardiogram and calcification evaluation via Echocardiographic Calcium Score (ECS), iii)Determination of changes in carotid intima-media thickness (cIMT) and Carotid stenosis iv)Standard ophthalmologic examination v)Direct measurement of Dephosphorylated-uncarboxylated MGP(dp-ucMGP) vi)Correlation with blood biomarkers

Eligibility Criteria:
Inclusion Criteria:

* ASYMPTOMATIC AV STENOSIS WITH AVA\>1 cm2 \& Vmax\<4m/s

Exclusion Criteria:

* AVK,STATINS,MSCT THE LAST 6 MONTHS,PROSTHETIC VALVES, AVA\<1 cm2,Vmax\>4m/s
A Multicenter, Open and Observational Real World Study on the Prognosis and Treatment in Young Women With Breast Cancer

This is a multicenter, open and observational real world study. The main purpose of this study is to map the genomic variation map of young breast cancer patients in China, and to analyze the relationship between gene mutation and therapeutic effect of young breast cancer patients. The secondary purpose was to analyze the relationship between gene mutation and prognosis of young breast cancer patients.

We expect to enroll 2000 young breast cancer patients (≤35 years old). All patients were detected by targeted next generation sequencing （NGS）(600+ gene panel). Clinical diagnosis, treatment and prognosis information were collected. The Stratification factors mainly include stage, molecular type and treatment method.

The study can only be formally carried out with the written approval of the ethics committee. We regularly submit annual research reports to the ethics committee. We will inform the ethics committee in writing when the study is discontinued and / or completed.

All patients were required to sign informed consent before entering the group. All updated versions of informed consent and written information will be provided to the subjects during the participant's participation.

In the experimental design stage, the statistical principle was used to make reasonable and effective arrangements for the relevant factors. Employ statistical experts to calculate the sample size and data statistics, and participate in the design process. Data collection and follow-up were conducted by specially assigned personnel, professional doctors were assigned to conduct data review regularly, and special data management personnel were provided. They will ensure the authenticity, reliability and security of data throughout the process.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed as breast cancer.
2. The age of diagnosis was 18-35 years old.
3. ECOG score was 0-2, and the expected survival time was more than 3 months.
4. No serious complications; no liver, kidney, hematopoiesis dysfunction.
5. Informed consent, and patients willing to long-term follow-up. -

Exclusion Criteria:

1. 4 weeks before the start of the study, the use of drugs other than the trial, or participate in another clinical study at the same time, or others with an impact on the results of this study.
2. Having a clear history of neurological or mental disorders (including epilepsy or dementia).
3. Patients have uncontrollable complications, including active infection, symptomatic congestive heart failure, unstable angina pectoris, arrhythmia, decompensated diabetes, uncontrollable hypertension or mental disorders.
4. Pregnant or lactating female patients.
5. HIV infected patients.
6. Patients with other tumors.
7. After comprehensive evaluation, the researchers believe that patients are not suitable for this study.
Transfer of Bone Marrow Derived Stem Cells for the Treatment of Spinal Cord Injury

This study is based on preclinical (animal) studies showing that infusing bone marrow-derived mesenchymal stem cells into the spinal fluid may contribute to improving neurologic function in animal models with spinal cord injuries. Bone marrow (BM) contains several types of stem cells that can produce functional cells. This includes cells that could help the healing process of damaged neurologic tissue.

The primary objective of this study is to see if the injection of these cells, obtained from your own bone marrow, is safe. A secondary objective is to evaluate if the treatment can provide functional improvements (neuromuscular control and sensation) in the affected areas.

A Phase I, single-center trial to assess the safety and tolerability of an intrathecal infusion (lumbar puncture) of autologous, ex vivo expanded bone marrow-derived mesenchymal stem cells in a well-defined population of spinal cord injury patients.

Safety will be evaluated by neurological and non-neurological tests performed after short-term (1 to 30 days) and long-term (2 to 12 months)follow-up evaluation periods after cell infusion.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65
* American Spinal Injury Association Impairment Scale A
* Clinical evidence of lesions located below c-spine 5 (C-5)
* Confirmation by MRI of injury level
* Time between injury and enrollment greater than 2 weeks
* Ability to provide informed consent
* Platelet count greater than 100 Thousand/uL at screening
* INR equal to or less than 1.5
* Hematocrit less than 30% prior to bone marrow aspiration
* Spinal cord injury within 60 months of screening

Exclusion Criteria:

* Anoxic brain injury
* Inability to provide consent
* Sepsis
* Neurological deficits attributed to lesions above C-5
* Cerebro-vascular accidents with intracranial hemorrhage, acute brain injuries, meningitis, hydrocephalus or other potential diseases where the pressure in the cerebro spinal fluid is increased
* Multiple sclerosis
* Amyotrophic lateral sclerosis
* Cerebral Palsy
* Evidence of cancer over the last 3 years prior to enrollment
* Immunosuppressive diseases
* Platelet count lower than 100,000
* White blood count greater than 15,000 unless the patient is on steroids
* Bleeding disorders
* Clinical or laboratory evidence of meningitis
* Skin infection at the infusion site
* Pregnant or planning to become pregnant
In Vivo Quantification of Dental Demineralisation Using OCT With and Without Esomeprazole

Dental erosions in 30 male and female patients with proven abnormal gastrooesophageal reflux will be assessed clinically and using a novel optical coherence tomography (OCT) laser technique before and after double-blind randomization to antisecretory treatment with esomeprazole 20mg or placebo bid for 3 weeks.

The primary objective is to quantify tooth substance loss as well as changes in optical reflectance and scattering of dental hard tissues with and without acid inhibition.

Secondary objectives are:

To compare standardised visual scoring with OCT quantification of reflux damage at the different time points on different teeth.

To assess sex differences in OCT- quantified dental tissue loss.

Dental erosions in 30 male and female patients with proven abnormal gastrooesophageal reflux will be assessed clinically and using a novel optical coherence tomography (OCT) laser technique before and after double-blind randomization to antisecretory treatment with esomeprazole 20mg or placebo bid for 3 weeks.

The primary objective is to quantify tooth substance loss as well as changes in optical reflectance and scattering of dental hard tissues with and without acid inhibition.

Secondary objectives are:

To compare standardised visual scoring with OCT quantification of reflux damage at the different time points on different teeth.

To assess sex differences in OCT- quantified dental tissue loss

Eligibility Criteria:
Inclusion Criteria:

1. Dental erosions with Lussi score greater than 1, diagnosed by dentist
2. Provision of informed consent
3. Male or female aged 18 or above years
4. GORD defined by time with pH\<4 greater than 3.5% during 24 hours demonstrated by 24h-hour pH-metry in the last 6 months before the start of the study

Exclusion Criteria:

1. Significant illness within 2 weeks of study begin as judged by investigator.
2. Established or suspected non-reflux causes for dental erosions.
3. Inadequate exclusion of other causes for dental erosions (diet, psychiatric, bruxism, salivary abnormalities, vomiting, etc).
4. Inability or unwillingness to give informed consent.
5. Inability to attend all study.
6. New dental treatment (including dental products) may not be begun from 2 weeks before study begin until the end of the study, except usual dental hygiene with usual toothpaste.
7. Allergy to or other contraindication for treatment with esomeprazole.
8. Use of proton pump inhibitors in 2 weeks or other acid inhibitory drugs in 3 days before study inclusion.
9. Substantial change or planned change in dietary pattern, esp. diets within 2 weeks of study start and for the duration of the entire study.
10. Change or planned change in normal medication or use of herbal, mineral, vitamin preparations within 2 weeks of study start and until the end of the study.
11. Congenital dental defects.
12. Ongoing pregnancy or breast-feeding.
Diagnostic and Prognostic Significance of Computerized Cytologic Morphometry of the Thyroid Neoplasm

The prevalence of thyroid nodule is worldwide high. About 40% of normal population has thyroid nodules and about 5% are malignancy. It is important to differentiate malignancy from benign nodules because the management is completely different. Nowadays, the gold standard is fine needle aspiration cytology (FNAC) examination. The overall sensitivity and specificity is fair (\~90%), but still has its limitation that some results are indeterminate in about 15% of the nodules. These obstacles are especially troublesome for papillary and follicular thyroid cancer that leads to delayed diagnosis, incomplete resection, and repeated operation. Preoperative evaluation of the prognosis is extraordinary important for cancer management. However, current prognostic scoring systems is only applicable after surgery. Hence, we urgently need a better risk-stratification system for individual-tailored treatment, and genetic-based computerized morphometry study seems to be the most realistic and promising one. The goal of this study is to propose a reliable method for diagnosis and prognosis of papillary thyroid cancer and follicular thyroid cancer through analyzing cellular morphologic characteristics.


Eligibility Criteria:
Inclusion Criteria:

* patients who previously had received thyroid fine needle aspiration cytology examination

Exclusion Criteria:

* patients who are younger than 20 years old
High-Shear Microfluidic Thrombosis Assay

The purpose of this study is to characterize a new test to assess the rate and time it takes to form a blood clot in people who either do or do not take aspirin.

It is estimated that approximately 25% of people are resistant to aspirin, or do not respond to its effect. These individuals have a four fold higher risk of a heart attack or stroke compared to those who respond to aspirin. Current tests for determining those who are aspirin resistant are not reliable. This study is assessing the effectiveness of a new assay in determining the rate and time it takes for people who are or are not on aspirin in forming a blood clot.

Eligibility Criteria:
Inclusion Criteria for "no aspirin" group:

* have not taken aspirin, other nonsteroidal anti-inflammatory drugs (NSAIDs), or clopidogrel in the previous 10 days
* no history of myocardial infarction, ischemic stroke, or other ischemic event

Inclusion Criteria for "aspirin daily" group:

* have taken aspirin daily over the last 10 days or more
* no history of myocardial infarction, ischemic stroke, or other ischemic event

Inclusion Criteria for "new to aspirin" group:

* have not previously been prescribed aspirin, but have been prescribed aspirin at their present appointment, e.g. a high calcium plaque score on CT
* no history of myocardial infarction, ischemic stroke, or other ischemic event

Exclusion Criteria:

* a known bleeding or thrombotic disorder

Exclusion Criteria for "new to aspirin" group:

* a known bleeding or thrombotic disorder
* have taken aspirin, other NSAIDs, clopidogrel, or an anticoagulant in the previous 10 days
Cancer Patient Remote Monitoring for Timely Communication Study

The study is designed as a prospective, single-arm observational, mixed-method study. Patients with stage IV NSCLC or inoperable mesothelioma will be included and will be treated with immunotherapy according to current guidelines and standard of care. Patients may receive either a PD1/L1 inhibitor monotherapy or, if indicated, together with a CTLA4 inhibitor. Immunotherapy may be administered alone or together with chemotherapy as per site standard/physician's choice. Patients will be given access to a mobile app. Patients will receive daily questions via the app to assess immune-related adverse events between clinic visits and their well-being.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent Form
* Age \> 18 years at the time of study entry
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Life expectancy \> 6 months
* Patient is able and willing to use smart phone and a wearable device/technology/sensor

Exclusion Criteria:

* Previous systemic treatment for metastatic or locally advanced disease