cyrilzakka/clinical-trials huggingface dataset:
Role of Coronary CTA on Lipid Management and Risk Factors Control in an Asymptomatic Chinese Population

The primary objective of this study is to determine whether coronary computed tomography angiography (CCTA) -based coronary heart disease(CHD) prevention strategy improves lipid-lowering treatment and cardiovascular risk factor control compared with traditional CHD prevention strategy, guided by a cardiovascular risk score.

At present, doctors usually use a "risk score" to identify people at risk of heart disease who may benefit from medical treatment. In the RESPECT study the investigator will compare this "risk score" to coronary CTA scan. In this study the investigator would like to determine the effect of coronary CTA scan on lipid-lowering treatment and cardiovascular risk factor control.

This study will recruit 3400 eligible community volunteers (asymptomatic individuals free of any known cardiovascular event) aged 40 to 69 years, then, randomized (1:1) them to receive individualized primary prevention programs for coronary heart disease based on CCTA results or traditional risk score, as recommended in the Chinese CVD prevention guidelines. The intervention strategies in this study are consistent with RESPECT trial.

The investigator will assess the difference of lipid-lowering treatment and cardiovascular risk factor control between two groups 12 months later. Furthermore, the investigator will present the results of subclinical coronary atherosclerosis in participants who have undergone coronary CTA scans. This will help us understand the prevalence of subclinical coronary atherosclerotic disease in an asymptomatic Chinese population.

Eligibility Criteria:
Inclusion Criteria:

1. Nanjing residents who have no plans to leave in the next 5 years
2. Aged from 40 to 69 years
3. Free of any known clinically cardiovascular disease Able to comprehend and sign an informed consent form

Exclusion Criteria:

1. Serious liver dysfunction, defined as AST or ALT \> 3 times the normal upper limit
2. Chronic kidney disease (CKD) \> stage 4, defined as eGFR \< 30 ml/min/1.73 m2
3. Prior CCTA or invasive coronary angiography within the last 5 years
4. Any contraindications for CCTA
5. Previous use of statin or non-statin lipid-lowering medication (such as ezetimibe, PCSK9 inhibitor and XueZhiKang)
6. Life expectancy \< 3 years
7. Other reasons the researcher deems inappropriate to attend
Evaluation of the Automatic Deformable Recontouring on the Daily MVCT for Head and Neck Cancer Adaptive Radiotherapy

This trial is a prospective, monocentric study aiming to evaluate an adaptive radiotherapy method (automatic deformable recontouring on the daily MVCT (MegaVoltage Computerized Tomography)) using the Precise ART™ software in patients with head and neck cancer.

Patients will receive helical intensity-modulated radiotherapy (IMRT) according to the standard recommendations (35 fractions during 7 weeks). Radiotherapy will include daily repositioning MVCT.

For the study, patients will undergo 4 intermediate re-planning CT-scan (without injection of intravenous contrast agent) at week 3, week 4, week 5 and week 6 of treatment.

3 recontouring modalities will be evaluated for the study:

* Manuel recontouring (standard method)
* Precise ART™ deformed contours
* Precise RTX™ deformed contours

The total duration of the study for each patient will be 7 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old
2. Patient with histologically proven locally advanced head and neck cancer (Oropharynx, hypopharynx, larynx, nasopharynx, oral cavity, sinuses, nasal cavities, ethmoid sinus, cavum, salivary glands)
3. Cancer with nodal involvement (at least T3 or involved node \>2 cm)
4. Eastern Cooperative Oncology Group performance status 0 or 1
5. No previous curative treatment for head and neck cancer (surgery and/or radiotherapy and/or chemotherapy)
6. Indication of exclusive radiotherapy (+/- chemotherapy) validated in multidisciplinary meeting
7. Patient affiliated to the french social security system.
8. Patient must provide written informed consent prior to inclusion in the study and any study-specific procedure.

Exclusion Criteria:

1. Patient with metastatic cancer
2. Eastern Cooperative Oncology Group performance status ≥ 2 (due to comorbidities)
3. Patient with recurrent disease
4. Patient who required urgent surgical treatment
5. Contraindications to radiotherapy
6. History of cancer within 5 years
7. Patient already included in another therapeutic trial
8. Pregnant or breastfeeding women
9. Any psychological, familial, geographical or sociological condition potentially preventing the medical follow-up and/or study procedures
10. Patient protected by law
3D DL Ozteo in the Detection of Osseous Changes in Patients with Inflammatory Arthritis

This project intends to explore and validate the utility of new MRI pulse sequence, 3D DL oZTEo, in the detection of osseous erosions of the hand in patients with inflammatory arthritis. The detection of osseous structural changes, such as erosive disease, is routinely assessed in patients with rheumatic conditions such as rheumatoid arthritis, as it alters clinical management, and in some cases assists in diagnosis. Currently, this is most often assessed with radiography and conventional MRI.

This project intends to explore and validate the utility of new MRI pulse sequence, 3D DL oZTEo, in the detection of osseous erosions of the hand in patients with inflammatory arthritis.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients ≥18 years of age
* Hand radiographs performed within the past 3-6 months with imaging results available for analysis
* Hand radiographs confirm the presence of bony erosions
* Scheduled for a hand MRI as part of their routine clinical care at Mayo Clinic Rochester

Exclusion Criteria:

- Less than18 years of age
Effect of Smartphone Addiction on Myoelectrical Activity of Sternocleidomastoid Muscle in Adult

This study will be conducted to identify the effect of smartphone addiction myoelectrical activity on sternocleidomastoid in adults by measuring The amplitude of EMG signals of the sternocleidomastoid muscle in adults and Root mean square of EMG signals of the sternocleidomastoid muscle in adults


Eligibility Criteria:
Inclusion Criteria:

* Subject's age range from 18-30 years old
* All participants use the same smartphone with a touch screen of 6,7 inches.

Exclusion Criteria:

* Neck pain ( spondylosis, spondylolysis)
* Systemic diseases.
* Spinal deviation
Interventions for Residual Dizziness After Successful Repositioning Maneuvers in Patients With BPPV

To investigate the effect of vestibular rehabilitation, with or without medication, on resolving residual dizziness after successful repositioning maneuvers in patients with benign paroxysmal positional.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed as unilateral BPPV (unilateral posterior semicircular canal BPPV or horizontal semicircular canal BPPV) according to the clinical practice guideline issued by American Academy of Otolaryngology and head and neck surgery (AAO-HNSF) in 2017;
2. Aged 18\~80 years;
3. Reporting residual symptoms after successful repositioning maneuvers;

Exclusion Criteria:

1. Anterior semicircular canal BPPV or multicanal BPPV;
2. Recurrent BPPV;
3. Subjects with coexisting vestibular disorders, including Meniere disease, vestibular neuritis, labyrinthitis, and peripheral vestibular loss;
4. Subjects with severe cervical spine disease;
5. Subjects with severe cardiovascular diseases ;
6. Subjects with known cerebral vascular disease like carotid stenosis;
7. Cognitive impairment;
8. Suspect of significant depression or anxiety as defined as a score of ≥ 8 for each respective scale of Hospital anxiety and depression scale;
9. Pregnant/ lactating or planning to become pregnant during the study period;
10. Had taken vestibulosupressant, antihistamines, and/ or ototoxic medications in the past 3 months;
Cervical Unilateral Antero-posterior Mobilization and Thoracic Central Postro-anterior Mobilization in Treatment of Shoulder Impingement Syndrome

Shoulder impingement syndrome (SIS) is a complex, multi-factorial problem that is treated with a variety of different conservative options. The conservative option that has shown effectiveness is manual therapy of the cervical and thoracic spine

This study will be conducted to answer the following question:

What is the effect of adding cervical and thoracic mobilization to selected therapeutic exercise Program on pain intensity, Pain-free shoulder flexion and scaption active ROM, muscle strength of external rotator and abductors, shoulder functional status in patients with Shoulder Impingement Syndrome

Eligibility Criteria:
Inclusion Criteria:

* • patients who had received at least two positive signs on their Neer sign, Hawkins sign, supraspinatus test, apprehension test, and relocation test

  * Patients report pain on elevating the arm between 70 ° and 120 ° (the "painful arc"), on forced movement above the head, and when lying on the affected side

Exclusion Criteria:

* • cervical radiculopathy

  * a history of shoulder surgery
  * corticosteroid injection within the past month
  * Subjects who had received physical therapy treatment for their shoulder within the past three months.
Home-based Respiratory Physiotherapy and Telephone-Based Psychological Support in Severe COVID-19 Patients

Some COVID-19 survivors may have respiratory and mental health sequelae, especially those who required hospitalization. The investigators hypothesize that the participation of a rehabilitation program composite by home-based respiratory physiotherapy and telephone-based psychological support will improve respiratory function, quality of life, and psychological status in severe COVID-19 patients.

In Peru, almost one million persons have survived COVID-19 and initial reports indicate that could exist long-term health damage. This study aims to assess the efficacy of a 6-week rehabilitation program following hospital discharge for patients who had severe COVID-19. The program includes 12 sessions of home-based respiratory therapy that the patient will carry out with a physiotherapist and 7 sessions of telephone-based psychological support bring by a psychologist.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 75 years
* Be discharged from hospitalization with a COVID-19 confirmed diagnosis
* Be able of understanding study procedures
* Be able to give informed consent
* Required oxygen flow greater than 6lt/min or through a high flow device at any time during hospitalization
* Have been evaluated by the rehabilitation service at least once during the hospitalization

Exclusion Criteria:

* Contraindications to six-minute walk test
* Contraindications to spirometry
* Complications during the baseline six-minute walk test
* Have neurological pathology, neuropathy, limb dysfunction, or other underlying physical disability that makes physical exercise impossible
* Be pregnant or breastfeeding
* Do not have access to the Internet or a telephone line
* Have previous lung diseases like asthma, COPD, fibrosis, or tuberculosis
* Moderate or severe heart disease (Grade III or IV, New York Heart Association)
* Have had another severe disease in the last six months
* Severe depression or suicidal intention
* Be taking any medication for depression, anxiety, or other medication prescribed by a psychiatrist prior to the onset of a COVID-19 condition
* Have cognitive impairment or sensory disturbance
Acute Health Effects of Passive Vape Among COPD Patients

The use of e-cigarettes is often permitted in otherwise smoke-free areas causing passive vape exposure for present individuals. Little is known about the potential adverse health effects of passive vape, and people with respiratory diseases may be more susceptible.

The aim of the present study was to investigate local and systemic effects of short-term passive exposure to vape from e-cigarettes among patients with mild or moderate chronic obstructive pulmonary disease COPD in a randomized controlled double-blinded cross-over study.

Introduction: The use of e-cigarettes is often permitted in otherwise smoke-free areas causing passive vape exposure for present individuals. Little is known about the potential adverse health effects of passive vape, and people with respiratory diseases may be more susceptible.

Aim: to investigate local and systemic effects of short-term passive exposure to vape from e-cigarettes among patients with mild or moderate chronic obstructive pulmonary disease (COPD).

Design: In a randomised double-blinded cross-over study non-smoking COPD patients were exposed for four hours at two different exposure conditions separated by 14 days; A) clean filtered air and B) passive vaping under controlled environmental conditions.

Measurements: TSI P-TRAK Ultrafine Particle Counter was used for particle counts. Health effects, including lung function (FEV1/FVC) and fraction of exhaled nitric oxide (FeNO) were evaluated in relation to local and systemic effects prior to, right after and 24 h. after exposure.

Analysis: Mixed methods approach taking both time and exposure into account.

Eligibility Criteria:
Inclusion Criteria:

* Never smoker or ex-smokers ≥ 6 months
* Aged 18+
* A known diagnosis of COPD (FEV1/FVC \< lower limit of normal, app. 70%)
* MRC ≥ 2 or CAT score ≥ 10

Exclusion Criteria:

* Exposure to smoking more than 30 min./day
* Treatment with inhaled or oral corticosteroids
* Known hypersensitivity to constituents in e-cigarettes
* Any other disease that could influence the study parameters
* Conditions that prevent safe access to the climate chambers (such as claustrophobia)
* Perennial rhinitis
* Deformed nasal airways
* Not being able to change from long-acting medication to short-acting medication
COVID-19 and Liver Injury in Patients With or Without Underlying Liver Disease: A Multi-centre Retrospective-prospective Observational Study

COVID-19 and liver injury in patients with or without underlying liver disease: A multi-centre retrospective-prospective observational study.

All patients infected with SARS-CoV-2 and admitted to the COVID-19 ward/ICU of Max Hospital Saket (either in East Wing , Max Super Specialty Hospital, Saket or MAX Smart Super Specialty Hospital, Saket) between 1/4/2020 to 30/6/2020 (retrospective data between 1/4/2020- 30/5/2020 \& prospective data from approval till 30/6/2020), will be included

COVID-19 and liver injury in patients with or without underlying liver disease: A multi-centre retrospective-prospective observational study.

All patients infected with SARS-CoV-2 and admitted to the COVID-19 ward/ICU of Max Hospital Saket (either in East Wing , Max Super Specialty Hospital, Saket or MAX Smart Super Specialty Hospital, Saket) between 1/4/2020 to 30/6/2020 (retrospective data between 1/4/2020- 30/5/2020 \& prospective data from approval till 30/6/2020), will be included Primary objectives

1. To study the prevalence of liver live injury \& factors associated with among patients in-fected with SARS-CoV-2.
2. To study the prevalence of new liver injury and factors associated with it, among patient with underlying liver disease who develops COVD-19.

Secondary objectives

1. To correlate the presence and degree of liver dysfunction with the clinical outcomes in these patients.
2. To define the incidence of development of acute liver failure among these patients

Eligibility Criteria:
Inclusion Criteria:All patients infected with SARS-CoV-2 and admitted to the COVID-19 ward/ICU of Max Hospital Saket (either in East Wing , Max Super Specialty Hospital, Saket or MAX Smart Super Specialty Hospital, Saket) between 1/4/2020 to 30/6/2020 (retrospective data between 1/4/2020- 30/5/2020 \& prospective data from approval till 30/6/2020), will be included.

-

Exclusion Criteria:

1. Patients less that 18 years old with COVID-19
2. Pregnant ladies with COVD-19
3. Unwilling to give consent for inclusion
A Safety Study of SGN-CD123A in Patients With Acute Myeloid Leukemia

The study will examine the safety profile of SGN-CD123A. The study will test increasing doses of SGN-CD123A given every 3 weeks to patients.

This study is designed to evaluate the safety, tolerability, and preliminary estimate of antitumor activity of SGN-CD123A. The study will be conducted in 2 parts:

1. Part A is the dose-escalation portion of the trial, designed to identify the maximum tolerated dose (MTD) of SGN-CD123A
2. Part B is the dose-expansion portion of the trial, designed to evaluate SGN-CD123A in patients with differing CD123 expression levels

Dose-escalation in Part A will be conducted using a 3+3 study design. Patients with CD123-detectable AML will be enrolled in cohorts at escalating doses of study drug and will receive up to 2 induction cycles of SGN-CD123A treatment at an assigned dose level in 3-week cycles.

After completion of dose-escalation, patients will be enrolled in Part B of the study. Patients enrolled in Part B will receive up to 2 induction cycles of SGN-CD123A treatment at a dose level and frequency determined by results in Part A.

For both Part A and Part B, a third induction cycle may be permitted with the approval of the study medical monitor. If a patient achieves a complete remission or complete remission with incomplete hematologic recovery, optional post-remission cycles of SGN-CD123A may be administered.

Eligibility Criteria:
Inclusion Criteria:

* Relapsed/refractory acute myeloid leukemia following at least 2 but no more than 3 prior regimens
* Patients may be eligible after only 1 previous regimen if in a high risk category
* Adequate baseline renal and hepatic function
* Eastern Cooperative Oncology Group Status of 0 or 1
* CD123-detectable leukemia

Exclusion Criteria:

* Cerebral/meningeal disease related to underlying malignancy
* Promyelocytic leukemia
* History of clinically significant pulmonary fibrosis or documented diffusing capacity of the lung for carbon monoxide \<50% predicted
* Prior hematopoietic stem cell transplant
* Antileukemia or experimental treatment within 4 weeks of study drug (other than hydroxyurea or 6-mercaptopurine)
* Cardio or cerebral vascular event within 6 months
Validation of BodPod in Pediatric Anorexia Nervosa

Anorexia nervosa is a severe cause of undernutrition. It leads to a dramatic decrease of weight with an important modification of the body composition. During the renutrition phase, disharmonious body composition recovery is a relapse factor. Dual X-ray absorptiometry (DXA) is the gold standard to study body composition in children with anorexia nervosa. But, due to technical limits, DXA analysis needs to take in account a potential failure to thrive with an adjustment on height. Moreover DXA needs an irradiation which does not allow close repeat measurements. Since several years, a simple, non-invasive, non-irradiant method for measure of body composition has been developed in pediatrics: the air displacement plethysmography (ADP). Actually, only one device is available for this measurement: the BodPod®. However, feasibility and accuracy of ADP compare to DXA have not been evaluated in pediatric anorexia nervosa. The aim of this study is to compare the accuracy of BodPod® compare to DXA in girls with anorexia nervosa.


Eligibility Criteria:
Inclusion Criteria:

* Female patients aged between 8 and 18 years
* Female with a diagnosis of anorexia nervosa according to the DSM V classification, restrictive type or hyperphagic / purgative access type, evolving for less than 3 years.
* Female who received explanations adapted to their level of understanding for this study
* Female who expressed their consent to participate to this study
* Female whose parents or holders of parental authority have been informed and signed free and informed consent
* Female affiliated to a social security scheme

Exclusion Criteria:

* Patients with psychotic symptoms
* Patients with claustrophobia
* Patients with severe respiratory disease
A Study of IBI311 in Healthy Volunteers

It is designed for Multi-center, double-masked, randomized, placebo- control study with dose escalation phase I trial to evaluate the safety, tolerability, PK and immunogenicity profiles of a single intravenous injection of IBI311 in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to sign informed consent form and comply with visit and study procedures per protocol.
2. Male or female subjects with age of 18\~45 yrs.
3. Female subjects of childbearing age or male subjects with childbearing age female partner agree to take effective contraceptive measures from the screening period to 120 days after the end of treatment.

Exclusion Criteria:

1. Have a history of or any evidence of chronic diseases of liver, kidney, cardiovascular, nervous/mental, digestive tract, respiratory, urinary and endocrine systems.
2. Have received prior treatment with another anti-IGF-1R monoclonal antibody.
3. History of drug, alcohol, or chemical abuse within 6 months prior to screening.
4. History of positive HIV antibody, HCV antibody, Syphilis check, HBV positive during screening period.
5. Receipt of a live vaccine within 180 days prior to screening or expected to receive live vaccine during study period.
6. History of recurrent significant infection or history of recurrent bacterial infections.
7. Must not have a history of tinnitus or hearing impairment.
8. Must not have received an investigational agent for any condition within 90 days.
9. Female volunteers must not be pregnant or lactating.
Prestudy: Lifestyle and Cardiovascular Disease

The purpose of this pilot study is to optimize conditions for a planned human intervention study focusing on how diet predispose for, and influence, lifestyle disease development and its consequence in cardiovascular disease development.

Common for many of the risk factors of lifestyle diseases is that they are induced by improper diet. Recent research has shown that especially total amount and composition of the macro nutrients, protein, carbohydrate and fats, is important.

A time course experiment has been performed where 5 subjects underwent a diet intervention for four weeks with a controlled, balanced macro nutrient energy content of every meal. The sampling time points were 0, 1, 2, 7, 14 and 28 days. The goals were to determine optimal length of intervention with stabilization of gene expression to occur and compare blood and subcutaneous abdominal fat tissue as source of biological material for RNA for DNA microarray analysis. Microarray analysis were performed on 3 of the 5 subjects.

Eligibility Criteria:
Inclusion Criteria:

* healthy males, BMI\>30

Exclusion Criteria:

* known chronic disease or in need of any medical treatment
Iranian Intensive Care Unit (ICU) Glutamine Study

This is a double-blinded placebo-controlled block randomized study in intensive care patients comparing enteral glutamine supplementation to placebo. The hypothesis is an improvement of clinical and paraclinical outcomes. The primary endpoint is Infection Probability Score (IPS) and Systemic Inflammatory Response Syndrome (SIRS). Anthropometric measures and serum inflammatory mediators will be compared.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-60
* No corticosteroids use
* No history of heart, liver and kidney diseases
* Nutrition through nasogastric or orogastric

Exclusion Criteria:

* Patients who will not tolerate enteral nutrition for more than 48 hours
* Patients who are NPO and nutritional support has not started
* Lactating and pregnant women
* Kidney failure during the study
* A history of glutamin supplement use before the study