cyrilzakka/clinical-trials huggingface dataset:
Risk Factors Associated With the Global Burden of Disease in Reunion Island and Comparison With Mainland France and Indian Ocean Countries

The question posed by this project is that of the regional estimate of the relative importance of the risk factors of the main pathologies. Our hypothesis is that these risk factors are of different relative importance in Reunion Island compared to metropolitan France.

The definition of health priorities in a given territory is a major field of Public Health research. The World Health Organization has been conducting the Global Burden of Disease study since the 1990s. This study, which has been the subject of numerous publications, aims at estimating the burden for a given population of different causes of mortality and morbidity. It defines a standardized measure allowing comparisons between different countries. The measure developed internationally is the "Disability-adjusted life year" (DALY). This also allows the monitoring of the relative importance of each pathology. This standardized classification of the relative importance of the pathologies and risk factors involved is a major public health tool.

This measure was developed at the international level initially and then recently applied locally (London neighborhoods, US states). For the Indian Ocean zone, DALY values are available for Madagascar, Seychelles and Mauritius. The estimate of this measure for Reunion Island is based on data from metropolitan France. It therefore uses for Reunion mortality, morbidity, income per capita and social indicators of metropolitan France. It does not take into account the specificities of Reunion. In order to better understand Reunion's public health priorities, it seems important to decline this measure at the regional level. The implementation of this measure at the regional level corresponds to the research project AVIRON which aimed at collecting all the data for the calculation of the DALY in Reunion Island. The AVIRON-2 study, which extends AVIRON's focus on morbidity and mortality, will aim at determining the attributable part of the various disease risk factors and to classify these risk factors according to their importance in a given population for all diseases.

Eligibility Criteria:
Inclusion Criteria:

The whole population living in Reunion Island

Exclusion Criteria:

People not living in Reunion Island
Effect of Vitamin D Supplementation on Muscular Strength, Musculoskeletal Pain and Headache

The primary aim of the present trial is to study the effect of daily vitamin D supplementation on muscular power and force among non-western immigrants living in Oslo, Norway, and secondarily to study the effect of musculoskeletal pain and headache.

The investigators have also prespecified a number of additional research questions about anemia, metabolism and bone turnover, inflammation, diabetes, lipids, itching and kidney function, which because of multiple comparisons should be interpreted with caution unless the statistical evidence for an effect is very strong.

Vitamin D deficiency is a widespread public health problem among immigrants from non-Western countries in Norway. As a background for preventive strategies it is important to have best possible knowledge about health consequences of poor vitamin D status, and in this respect much is lacking.

The investigators will aim to study the effect of vitamin D supplementation on muscular strength , musculoskeletal pain and headache among non-western immigrants in Norway with background from Middle East, Africa and South Asia. In addition the intervention gives us the opportunity to study the effect of vitamin D on indicators of other important health issues including anemia, diabetes , lipids, inflammation, metabolism and bone health. The study will also contribute with insight on how to achieve a high compliance. This is of interest in a broader context as poor compliance has been experienced as a problem in primary health care among immigrants with poor vitamin D status.

The study is a randomized, double blinded, placebo-controlled trial which compares two doses of vitamin D supplements, 400 IU and 1000 IU, with placebo and the tablets will be taken daily in a period of 4 months. Three muscle strength tests will be used, and they will be performed before and after the intervention: Counter movement jumps, Chair rising and Handgrip. Level and location of musculoskeletal pain and headache will be recorded at baseline and at end of the study.

A blood sample will be collected from the study subjects at baseline and after 4 months. The level of vitamin D and markers of anemia, metabolism and bone turnover, inflammation, diabetes, lipids and kidney function will be measured.

Eligibility Criteria:
Inclusion Criteria:

* Male and female between 18 - 50 years old
* Immigrants with background from Middle East, Africa and South Asia.

Exclusion Criteria:

* Daily use of vitamin D supplementation and frequently use of artificial UV light exposure.
* Pregnancy
* Malabsorptive disorders
* Fracture in the leg /arm within the preceding 6 months. Known osteoporosis
* Tuberculosis, sarcoidosis, cancer, kidney dysfunction, liver dysfunction and history of kidney stone.
* Regular use of medication that interfere with vitamin D/bone metabolism, such as glucocorticoids, diuretics, lithium, antiepileptics, bisphosphonates,
* Regular use of strong pain killers.
* Medication for diabetes
Clinical Performance of Investigational InRhythm PT/INR System in a Professional Use Setting

This study is designed to evaluate and verify the clinical accuracy of the InRhythm PT/INR system; a point-of-care, whole blood PT/INR measurement with a reference plasma based PT/INR using a laboratory reference instrument and reagent (Sysmex/lnnovin) calibrated to the WHO rTF09 reference standard.


Eligibility Criteria:
Inclusion Criteria - All

* The subjects must be \> 18 years of age.
* The subjects must be willing and competent to sign an informed consent.
* The subjects must be able to attend the clinic for one visit to donate one FS blood sample and one venous blood draw of approximately 10 cc.

Exclusion Criteria - All

* The subject is unable to donate fingerstick and venous blood samples.
* The subject has a history of clinically significant bleeding associated with incising the finger and/or the venipuncture.
* The subject is enrolled in any other study that involves an investigational drug and/or device.

Additional Inclusion Criteria - Therapeutic Group

* The subject must require oral VKA anticoagulant therapy.
* The patient must have been anticoagulated for at least three months prior to enrollment.

Additional Exclusion Criteria - Normal Group

- Subjects receiving any form of anticoagulation drugs such as Aspirin or Clopidogrel.
Surgical Positioning of the Arm During Thoracic Surgery -Effect on Shoulder Pain After Surgery?

Up to 85% experience shoulder pain after thoracic surgery, especially on the same side as surgery are performed. Referred phrenic nerve pain is probably one cause of ipsilateral shoulder pain (ISP), and positioning of the arm during surgery another. Studies indicates that ISP can be caused by the positioning of the patient during surgery due to muscle -and ligament strain. Can a change in the surgical positioning (less press and stretch) of the ipsilateral arm effect the shoulder pain after thoracic surgery?


Eligibility Criteria:
Inclusion Criteria:

* Men and women;18 years and older
* Thoracotomy for lung cancer
* Video assisted thoracic surgery for lung cancer.

Exclusion Criteria:

* Received treatment for shoulder pain
* Use pain medication on regular basis
* Under 18 year
* Length of stay in ICU more than 24 hours after surgery
* Does not understand the native language
Early Conversion of Dasatinib in CML-CP Patients

Chronic myeloid leukemia (CML) is a malignant disease of acquired hematopoietic stem cells. The BCR-ABL fusion gene is the pathogenic basis of CML. Tyrosine kinase inhibitors (TKIs) are targeted drugs for this fusion protein. With the wide clinical application of TKIs, the efficacy of CML patients has been greatly improved. However, there are still a significant number of patients who have poor response to the first generation of TKI drugs, imatinib, most of them have early molecular response failures (BCR-ABL（IS）\>10% at 3 or 6 months) ，which means lower rates of molecular response, increased risk of progression, and higher overall survival. For them, the early conversion of dasatinib might be a better choice.


Eligibility Criteria:
Inclusion Criteria:

1.18-65 years old； 2.CML-CP,and Imatinib treatment longest for 6 months ； 3.Q-pcr monitoring of BCR/ABLIS failed to achieve the best therapeutic effect（BCR/ABLIS\>10.00% in 3m or BCR/ABLIS\>1.00% in 6m）； 4.No previous history of malignant tumor; 5.Informed consent of the patient or his legal representative

Exclusion Criteria:

1. History of CML-CP or CML-AP;
2. Resistant to dasatinib,or treatment with imatinib more than 6 months;
3. Received allogeneic hematopoietic stem cell transplantation,or immunotherapy;
4. woman who is pregnant or nursing
5. Combined with other serious organic diseases, serious arrhythmia, pulmonary hypertension, cardiomyopathy, serious autoimmune diseases.
A Study to Compare Two Paracetamol Formulations.

A pharmacokinetic study investigating the rate and extent of absorption of paracetamol and an adjuvant from two different paracetamol formulations.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female volunteers aged 18-55 years with a body mass index ranging from 19-28 kilograms per square meter who have given informed consent
Safety and Efficacy Study of Umbilical Cord/Placenta-Derived Mesenchymal Stem Cells to Treat Myelodysplastic Syndromes

The purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells (MSCs) derived from human umbilical cord/placenta at a dose of 1.0E+6 MSC/kg on the subjects for refractory anemia (RA) and refractory anemia with ring sideroblast (RARS) of myelodysplastic syndromes (MDS).

Myelodysplastic syndromes are bone marrow stem cell disorders resulting in disorderly and ineffective hematopoiesis. MDS is characterized by variable degrees of cytopenias (anemia, neutropenia, and thrombocytopenia ) and risk of transformation to leukemia.

To date treatment of MDS is unsatisfactory: chemotherapy has a limited role in the management of leukemic progression; autologous stem cell transplantation does not prolong relapse-free survival and stem cell transplantation is poorly tolerated in older individuals. Some MDS patients have been shown to respond to a wide variety of immunosuppressive agents ranging from corticosteroids to CsA and antithymocyte globulin (ATG). However, the overall response rate is less than 30%. In fact, few treatments appear to change the natural history of MDS.

The management of MDS patients therefore remains to be improved. Human MSCs isolated from Wharton's jelly of the umbilical cord/placenta have been shown to have immunosuppressive, stimulating hematopoiesis and tissue repairing properties. This study will evaluate the safety and effectiveness of MSC transplant in the MDS patients.

This study will last about 3 years. Participants will be randomly assigned to receive either MSC transplant (Group 1) or CsA therapy alone (Group 2). Patients will undergo MSC transplant at the start of the study (defined as Day 0). After 3 months, patients will receive the second MSC transplantation when one responds well to the treatment. After 3, 6 and 12 months from the first transplantation, patients will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Patient age 18\~80 years old with plan to infuse MSCs.
2. Histologically documented or cytologically confirmed diagnosis of MDS with WHO classification of MDS-RA and MDS-RARS.
3. Patients must have an ECOG 0\~2.
4. No moderate or sever organ dysfunction: Ejection fraction\>45%; Creatinine \<176 mmol/L.
5. No active severe viral or fungus infection.
6. Each patient must sign written informed consent.

Exclusion Criteria:

1. Psychiatric condition that would limit informed consent.
2. HIV positive
3. Positive Pregnancy Test
4. Patient has enrolled another clinical trial study within last 4 weeks.
Efficacy of EGF-loaded Self Healing Gel in Treatment of Oral Mucositis

Cancer treatment, including radiation along with aggressive chemotherapy, increases the patient's survival rate. However, they possess toxic side effects. Oral mucositis is one of the most serious complications of cancer treatment, which occurs in most of patients receiving cancer therapy. Mucositis can dramatically affect the patient's quality of life .Epidermal growth factor (EGF) is a dominant factor in early keratinocyte differentiation, proliferation and migration. However, a major obstacle in most studies is that there isn't prolonged contact between the applied treatment and the oral mucosa to achieve the optimum therapeutic effect. Thus, a new vehicle for EGF is needed to achieve sufficient prolonged contact with oral mucosa. The present project aims at employing EGF as therapeutic agent for mucositis dealing with the challenges of delivery of such macromolecule to the oral mucosa by using self-healing gels to maximize the drug effect.


Eligibility Criteria:
Inclusion Criteria:

* Eligible patients are those over 18 years of age with WHO grade 3 or 4 oral mucositis receiving radio- or chemotherapy as treatment for head and neck cancer.

Exclusion Criteria:

* Patients with hematologic malignancies or those with known allergic reactions to the drug.
The Burden of COVID-19 Survivorship

This research study is being done to find out what the longer-term physiological consequences of COVID-19 are, and to determine if exercise therapy can help improve lung function, heart function and overall fitness, and reduce symptoms in people recovering from SARS-CoV-2.

The purpose of this research is to see if taking part in structured exercise training will improve the ability to exercise, the function of the lungs and the function of the heart, and reduce symptoms of fatigue and breathlessness in people recovering from COVID-19. After enrollment all patients will complete exercise testing, lung function testing, and cardiac imaging. Patients will be randomized to either 8 weeks of exercise training (4-5 times per week) or will continue standard medical care. All patients will undergo detailed exercise testing, lung function testing, and cardiac imaging after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Aged 21 to 75 years.
* History of RT-PCR proven SARS-CoV-2 infection.
* Deemed 'recovered' from SARS-CoV-2 infection.
* Not clinically obese (BMI ≥ 36) and/or suffer from musculoskeletal or other conditions that would limit exercise participation.
* No evidence of cardiac ischemia at rest or during exertion (via ECG).
* Able to provide written informed consent.

Exclusion Criteria:

* Individuals less than 21 or more than 75 years old.
* Not able to take part in structured exercise training due to injury or other conditions that would put person at risk during exercise.
* Unable to provide written informed consent.
Structured Comprehensive Intervention to Stimulate Self- Management and Improve Quality of Life in COPD Patients

This study evaluates the effect of of a structured self-management intervention plan in patients with chronic obstructive pulmonary disease in primary care setting.Half of the participants will receive the self-management plan while the other half will receive usual care.

Chronic Obstructive Pulmonary Disease (COPD) is a great magnitude public health problem with an associated increased mortality and a high cost (consumption of health care resources and loss of health related quality of life (HRQoL)). The comprehensive approach to this complex disease, focusing self-care promotion, improves HRQoL and the patients" clinical status, as shown by several studies, although further investigation is needed to confirm these results in the field of Primary Care (PC) and to formulate clear recommendations on the more effective type of intervention.

Hypothesis: In (moderate-severe) COPD patients, a structured self-management intervention plan in the setting of primary care, is more effective than usual treatment on the main outcomes associated with the disease: HRQoL, lung function, exacerbations and hospital admissions, at 6, 12 and 24 months of follow-up.

Objectives: To evaluate the impact of a comprehensive intervention plan to promote self-care and improve HRQoL in people with COPD in PC.

Methods: Multicenter randomized controlled trial, conducted at PC centers in Barcelona.

Determinations: Specific standardized and validated questionnaires, as the St George's Respiratory for the HRQoL. Statistical analysis: Intention to treat analysis. Descriptive statistics of the variables of the intervention and the control group to assess their homogeneity at the beginning of the study. An analysis of variance (ANOVA) will be used to assess differences among intervention groups.

Expected results: A significant improvement in HRQoL attributable to the intervention performed in patients with COPD Applicability and Relevance: To implement the intervention plan in clinical practice and to standardize its content.

Eligibility Criteria:
Inclusion Criteria:

* Patients with at least one visit at the primary care physician during the past year
* Patients with a diagnosis of moderate (FEV1 50% - 80%) or severe (FEV1 30% - 50%) COPD
* Patients treated with inhaled bronchodilators and accepting to participate in the study.

Exclusion Criteria:

* Patients unable to come to the primary care centre
* Patients with cognitive impairment and/or a severe mental condition.
* Patients with a diagnosis of asthma, tuberculosis or other chronic respiratory disease.
* Patients needing chronic oxygen therapy.
* Patients with any terminal disease
Retrospective Chart Review of Subcutaneous IgG Use in Infants

This study is a retrospective chart review of the use of subcutaneous IgG (SCIG) in infants less than two years old.


Eligibility Criteria:
Inclusion Criteria:

* Infants who received more than one dose of IgG by the subcutaneous route before the age of two years.
* Consent of parent/guardian if required by institution/IRB.

Exclusion Criteria:

* Infants with protein losing conditions such as lymphangiectasis, nephrosis, S/P cardio-thoracic surgery requiring drainage tubes for more than 48 hrs, protein losing enteropathy.
* Concomitant treatment with plasma, other blood products or IGIV while on SCIG.
* Lack of consent by parent/guardian (if required by Institution/IRB).
* Any other condition or treatment which, in the opinion of the local investigator, would interfere with obtaining valid results for that subject.
Physiological Variables and Rowing Performance.

The purpose of this study is to investigate the association between the changes in physiological variables based on fitness testing and the changes in rowing performance.

The literature has shown that both aerobic capacity and anaerobic capacity are important for exercise performance in rowing. Simple fitness tests (e.g., the modified Wingate test and the graded exercise test) have been validated to examine aerobic and anaerobic capacities in rowers. However, it remains unclear whether these fitness tests can be used to track rowing performance changes. The purpose of this study is to investigate the association between the changes in fitness test outcomes and the changes in rowing performance. The investigators expect that improvements in rowing performance are closely related to improvements in fitness test outcomes.

Participants will attend two sessions of fitness testing, one in the fall 2020 and one in the spring 2021. Each session will include the modified Wingate test to examine anaerobic capacity, the graded exercise test to examine the aerobic capacity, and the 2,000-meter rowing test on rowing ergometers to assess rowing performance.

Modified Wingate test:

After 3 minutes of warm-up at 40-50% of heart rate reserve, the participants will perform 30 seconds of rowing at maximal effort on the rowing ergometer.

Graded exercise test:

Workload will start from 25 Watts and it will be increased by 25 Watts by each stage until exhaustion. Each stage includes 2 minutes of rowing and 1 minute of rest.

2,000-meter rowing test: A 2,000-meter race simulation will be performed using an indoor rowing ergometer.

Eligibility Criteria:
Inclusion Criteria:

• Collegiate rowers

Exclusion Criteria:

* Cardiovascular diseases
* Pulmonary diseases
* Metabolic diseases
* Other contraindications to exercise
Assessment of Blood Coagulation Disorders in Patients With Pulmonary Hypertension

The objective of the present study is to assess blood coagulation disorders in patients with Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension. The investigators aim to evaluate any possible coagulation abnormalities related to the patients' primary disease and any possible effects the pulmonary hypertension- specific therapy may have on hemostasis.

Pulmonary hypertension (PH) is a chronic, progressive, pulmonary vascular disease with a multifactorial etiology and a not fully elucidated pathophysiological background. There is a complex and not adequately understood association between PH and the coagulation process.

The aim of the present study is to evaluate hemostasis in patients with PH classified as category 1 of the World Health Organization Pulmonary Hypertension Group (Pulmonary Arterial Hypertension, PAH) and 4 (Chronic Thromboembolic Pulmonary Hypertension, CTEPH). Patients with CTEPH are diagnosed as inoperable. The investigators perform diagnostic tests on blood samples collected directly from the pulmonary artery during the right heart catheterization performed as part of the patients' routine medical care for the diagnosis of the disease or for follow-up 6 months after the initiation of PH-specific treatment. All blood samples are processed by platelet function analyzer-100 (PFA-100), light transmission aggregometry (LTA), rotational thromboelastometry (ROTEM) and endogenous thrombin potential (ETP).The primary objective of the study is to assess platelet function, coagulation and anti-coagulation pathways and fibrinolysis in PAH and inoperable CTEPH patients and to investigate the possible effects of PH- specific therapy on hemostasis.

Eligibility Criteria:
Inclusion Criteria:

* Pulmonary Arterial Hypertension,
* Chronic Thromboembolic Pulmonary Hypertension.

Exclusion Criteria:

* renal insufficiency,
* hepatic insufficiency,
* thyroid dysfunction,
* malignancy,
* active infections,
* receiving anticoagulant or antiplatelet therapy,
* history of hemostatic disorders irrelevant to their primary disease,
* abnormal red blood counts.