cyrilzakka/clinical-trials huggingface dataset:
Cardiac Imaging in SARS-CoV-2 (COVID-19)

One-in-four patients with COVID-19 pneumonia develop life-threatening heart problems. Through cardiovascular imaging and biomarkers analyses this study aims to evaluate whether COVID-19 infection results in heart injury. The investigators will also investigate which patients are at risk of heart injury as a result of COVID-19 and why only some patients suffer heart problems as a consequence of the infection. The study will also assess multisystem involvement including the lungs and kidneys.

Our study is supported through the Chief Scientist Office Rapid Research in Covid-19 (RARC-19) programme. Our study will clarify the pathogenesis of cardiopulmonary injury, notably endotypes of myocardial injury including myocarditis, in patients with COVID-19.

The study involves a prospective, observational, multicentre, longitudinal cohort design.The investigators aim to minimise selection bias by adopting consecutive screening of all-comers hospitalised with COVID-19 and the eligibility criteria are broad. For example, severe renal dysfunction is not an exclusion criterion. The sample size is 180 patients enrolled at baseline with 160 attending for the primary outcome evaluation (cardiac imaging) at 28 days post-discharge. The investigators will use advanced cardiovascular imaging to identify the number (proportion) of patients with myocardial inflammation (myocarditis) that is sub-clinical (i.e. not diagnosed) or clinically overt. Cardiovascular MRI and CT coronary angiography will provide a comprehensive examination one month after discharge is intended to detect persisting cardiovascular complications and diagnose clinical endotypes. The investigators aim to clarify the pathological significance of serial changes in circulating troponin, NTproBNP and renal function. By correlating the MRI findings with troponin I and other measures of cardiovascular injury, such as NTproBNP, our results will inform care pathways that use these blood tests to guide the management of patients with COVID-19. Correlation of imaging findings with baseline clinical information, biomarkers, patient reported outcome measures and well-being in the longer term will help to clarify the clinical significance of cardiovascular complications in COVID-19. Since the design is observational, an interim analysis may be undertaken with the timing informed by the enrolment rate.

Longer term follow-up will include a 5-year visit, contingent on funding and ethics approval, and electronic health record linkage of vital status and episodes of NHS care.

Eligibility Criteria:
Inclusion Criteria:

* History of hospital attendance or hospitalisation for COVID-19, confirmed by a clinical diagnosis, laboratory test e.g. PCR and/or a radiological test e.g. CT chest or chest X-ray
* Age 18 years or more
* Capacity to provide written informed consent
* Able to comply with study procedures

Exclusion Criteria:

* Contra-indication to CMR e.g. severe claustrophobia, metallic foreign body
* Lack of informed consent
* Women who are pregnant, breast-feeding or of child-bearing potential without a negative pregnancy test
Hyaluronan in the Treatment of Painful Achilles Tendinopathy.

The primary objective of this study is to compare OSTENIL® TENDON (2% hyaluronan) and Extracorporeal Shock Wave (ESWT) therapy in the treatment of painful Achilles tendinopathy.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients between 18 and 75 years of age.
* Good general health condition.
* Signed written informed consent.
* Painful Achilles midportion tendinopathy since more or equal than 6 weeks.
* Pain according to VAS (Huskisson, 100 mm) more or equal than 40 mm.
* Ensured compliance of subjects over the whole study period.

Exclusion Criteria:

* Concomitant or previous participation in a clinical investigation within the last 3 months prior to study inclusion.
* Infection or relevant skin disease at study relevant site.
* Blood coagulation disorder or intake of blood thinner (e.g. Marcumar).
* Known hypersensitivity to hyaluronic acid (HA) preparations or to the constituents mannitol, sodium chloride, disodium phosphate and sodium dihydrogenphosphate.
* Contra-indications for ESWT application in study relevant area (e.g. recent surgery, malignant tumour, local osteomyelitis or open epiphysis).
* Severe intercurrent illness (e.g. uncontrolled diabetes mellitus, peripheral neuropathy), which in the opinion of the investigator, may put the patient at risk when participating in the study, or affect the patient's ability to take part in the study.
* Concomitant disease at study relevant site (e.g. insertion tendinopathy at Achilles tendon) influencing study evaluation.
* Diseases or characteristics judged by the investigator to be incompatible with the assessments and/or procedures for the study evaluation.
* Intake of concomitant medications not allowed which might interfere with the functional assessment of the study (e.g. immunosuppressive drugs within the last 3 months).
* Previous therapies (except non-steroidal anti-inflammatory drugs (NSAID)) at study relevant site within the last 4 weeks prior to study inclusion.
* Use of NSAIDs within the last week prior to study treatment.
* Recent history of drug and/or alcohol abuse (within the last 6 months).
* Pregnant or lactating females.
* Participants of childbearing age (pre-menopausal) who do not accept the use of methods of birth control with pearl index of at least 1 (i.e. oral contraceptives, vaginal ring, hormone-releasing Intrauterine Device (IUD), implants, depot syringes, hormone patch, double barrier method, tubal ligation, vasectomised partner,...) during the treatment period and the first 4 weeks of follow-up period.
* Subjects not capable of contracting and of understanding the nature, risks, significance and implications of the clinical investigation and unable to form a rational intention in the light of these facts.
* Subjects unable to understand informed consent or having a high probability of non compliance to the study procedures and / or non completion of the study according to investigator's judgement (e.g. illiteracy, insufficient knowledge of local language).
Study to Evaluate the Safety and Immunogenicity of SARS-CoV-2 Vaccine (IN-B009) in Healthy Adults (COVID-19)

This is a first in human, phase I, open-label, dose-escalation study to assess the safety, reactogenicity, and immunogenicity of a SARS-CoV-2 Vaccine (IN-B009) in healthy adults.

Total of 40 participants will be enrolled in 3 institutions : Seoul National University Hospital, Jeonbuk National University Hospital, and Chungbuk National University Hospital.

Safety, reactogenicity, and immunogenicity will be evaluated in healthy participants with administration of IN-B009 (Injected twice, 21-day-interval).

Eligibility Criteria:
Inclusion Criteria:

* Male or female participants between the ages of 18 and 55 years.
* Participants considered 'healthy' to be eligible for study participation.
* Participants who are willing and able to comply with all scheduled visits and other study procedures.
* Participants with Body mass index (BMI) within the normal range.
* Participants with deltoid muscle capable of IP injection.
* Those that agreed to using medically approved contraception.
* Female participants with potential pregnancy- Those that used medically approved contraception and has negative result at the pregnancy test.
* Capable of giving personal signed informed consent

Exclusion Criteria:

* Clinically significant symptoms prior to IP injection.
* Confirmed to be COVID-19 RT-PCR positive or to have made close contact with SARS-CoV-2 infected patient.
* History of virologically-confirmed SARS, MERS, or COVID-19.
* History of congenital or acquired immunodeficiency or autoimmune diseases.
* Positive result of hepatitis B, C, RPR test, or HIV.
* History of disorder that inhibits intramuscular injection of the vaccine.
* History of hypersensitivity and severe allergic reaction to any of the components of IP.
* History of malignant tumor within 5 years prior to the first IP injection.
* Clinically significant chronic diseases that could cause safety concerns regarding COVID-19.
* Scheduled of , or history of surgery under general anaesthesia prior to first IP injection,
* Female participant that is pregnant or is currently breastfeeding.
* Smoker or history of smoking within 12 weeks prior to first IP injection.
* Previous vaccination or treatment for prevention of COVID-19.
* Vaccination prior to the first IP injection or scheduled of vaccination after second IP injection.
* Treated with immunoglobulin and/or blood/blood components prior to first IP injection.
* Chronic use of immunosuppressant prior to first IP injection.
* Participated in other clinical study prior to first IP injection, or scheduled to participate in other study during the study period.
* Healthcare worker or emergency response personnel.
* Conditions that may influence the evaluation of the study objectives.
Minimum Dose Computed Tomography of the Thorax for Follow-up in Patients With Resected Lung Carcinoma

This study is designed to help decide whether a CAT scan performed at a very low dose of radiation (Minimum dose CT scan) is better than a Chest X-Ray in detecting recurrence of lung cancer in the chest (after surgery).

Lung Carcinoma is expected to kill 18,900 men and women in Canada in 2004. This is more than the combined total for the next three common cancers. The most important factor that determines patient survival is the stage of disease at presentation. Surgical resection is the best chance of cure. However, patients who undergo lung resection with curative intent have a significant incidence of a second lung cancer at 2% per year and a recurrence rate of 38% at 5 years. The current follow-up of these patients relies on periodic physical examination and chest radiography(CXR). However, CXR is insensitive in the detection of lung nodules when compared to standard Computed Tomography of the thorax (SDCT). Computed Tomography detects smaller lung nodules than CXR however, the radiation dose from a SDCT is roughly equivalent to 20 CXR examinations. Screening studies using Low Dose CT of the Thorax (LDCT) in subjects at high risk for lung cancer have demonstrated that LDCT detects three times as many nodules as CXR and four times as many primary lung cancers at one-third the dose of SDCT. Phantom and clinical work with LDCT performed at UHN/MSH suggests that a further reduction in radiation dose (Minimum Dose CT -MnDCT) is possible for nodule detection. Minimum dose CT is performed at a dose one sixth of a SDCT.In addition, if MnDCT is confirmed to be a more sensitive nodule detection technique, it could be used to

1. Increase the interval between repeat out-patient assessment and thereby 2. Reduce the overall cost of surveillance and inconvenience to the patient and 3. Free up clinic time for the surgeon to review more patients and reduce waiting lists

Eligibility Criteria:
Inclusion Criteria:

* lung cancer patients undergoing resection with intent to cure

Exclusion Criteria:

* age \< 18 years
Evaluation of the Anti-aging Efficacy of a Novel Skin Health Product

The aim of this study is to investigate the effect of cosmetic products with two different concentrations of the active on skin aging and in acting on the mitochondrial health of skin in comparison to a placebo product.


Eligibility Criteria:
Inclusion Criteria:

* Written Informed Consent to participate in the study
* Willingness to actively participate in the study and to come to the scheduled visits
* Female
* From 50 to 75 years of age
* Visible wrinkle in the face (grade 3 to 6 according to proderm scale) see Appendix 2
* Healthy skin in the test areas
* Vaccination of tetanus within the last 10 years (for biopsy sub group)

Exclusion Criteria:

* Female subjects: Pregnancy or lactation
* Drug addicts, alcoholics
* AIDS, HIV-positive or infectious hepatitis
* Conditions which exclude a participation or might influence the test reaction/evaluation
* Participation or being in the waiting period after participation in cosmetic and/or pharmaceutical studies pertaining to the test area
* Cancer not being diagnosed as cured and requiring chemotherapy, irradiation and/or hormonal treatment within the last 2 years
* Diabetes mellitus (type 1 and 2)
* One of the following illnesses with reduced physical capability/fitness: asthma (symptom-free allergic asthma is not an exclusion criterion), hypertension, cardiovascular diseases
* Documented allergies to cosmetic products and/or ingredients, skin care and/or skin cleansing products
* Intolerability against adhesive dressing (e.g. acrylate)
* Active skin disease at the test area
* Regular use of tanning beds
* Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, etc. at the test area that could influence the investigation
* Any topical medication at the test area within the last 3 days prior to the start of the study
* Medical treatment for wrinkle reduction (e.g. peeling with vitamin A or fruit acids) on the face within the last 2 weeks prior to the start of the study
* Systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines (e.g. antiallergics) within the last 7 days prior to the start of the study
* Systemic therapy with anti-phlogistic agents or analgetics (e.g. diclophenac), except for minor pain relief medicine like paracetamol within the last 3 days prior to the start of the study
* Therapy with antibiotics within the last 2 weeks prior to the start of the study
* Regular medication with anti-coagulating drugs like Aspirin®, Macumar®, etc. (e.g. for thrombosis prophylaxis) within up to 15 days prior to the taking of the biopsies
* Past cosmetic surgery procedure in the test area (e.g. laser, facelift)
* History of complications at wound healing (e.g. keloids, hypertrophic scars or contracture scar)
A Gene Transfer Therapy Study to Evaluate the Safety of and Expression From Delandistrogene Moxeparvovec (SRP-9001) in Participants With Duchenne Muscular Dystrophy (DMD)

This is an open-label gene transfer therapy study evaluating the safety of and expression from delandistrogene moxeparvovec in participants with DMD. The maximum participant duration for this study is 156 weeks.


Eligibility Criteria:
Inclusion Criteria:

* For Cohorts 1-7: Has a definitive diagnosis of DMD based on documented clinical findings and prior genetic testing.
* Cohort 1: Is ambulatory, and ≥4 to \<8 years of age at the time of Screening.
* Cohort 2: Is ambulatory, and ≥8 to \<18 years of age at the time of Screening.
* Cohort 3: Non-ambulatory per protocol specified criteria at the time of Screening.
* Cohort 4: Is ambulatory and ≥3 to \<4 years of age at the time of Screening.
* Cohort 5a: Is ambulatory and ≥4 to \<9 years of age.
* Cohort 5b: Non-ambulatory per protocol specified criteria at the time of Screening.
* Cohort 6: Is ambulatory, and ≥2 to \<3 years of age at the time of Screening.
* Cohort 7: Non-ambulatory per protocol-specified criteria at the time of Screening.
* Ability to cooperate with motor assessment testing.
* Cohorts 1, 2, 3, 5, and 7 only: Stable dose equivalent of oral glucocorticoids for at least 12 weeks before screening and the dose is expected to remain constant (except for modifications to accommodate changes in weight) throughout the first year of the study.
* Cohorts 4 and 6: Do not yet require use of chronic steroids for treatment of their DMD, in the opinion of the Investigator, and are not receiving steroids at the time of Screening.
* rAAVrh74 antibody titers are not elevated as per protocol-specified requirements.
* Genetic mutation inclusion criteria vary by cohort.

Exclusion Criteria:

* Has a concomitant illness, autoimmune disease, chronic drug treatment, and/or cognitive delay/impairment that in the opinion of the Investigator creates unnecessary risks for gene transfer.
* Exposure to gene therapy, investigational medication, or any treatment designed to increase dystrophin expression within protocol-specified time limits.
* Abnormality in protocol-specified diagnostic evaluations or laboratory tests.

Other inclusion/exclusion criteria apply.
Screening of the Frailty Degree in the Emergency Department Short Stay Unit

Screen all those\> 65 years of age admitted to the Short Stay Unit for frailty, and detect those who are potentially fragile.

Demographic change has led to a change in the profile and age of hospitalized patients, an increase in age and in patients with multiple chronic diseases and more complex health needs is observed.

Frailty is known to impact patient health outcomes with medical and surgical procedures. Thus, frailty is correlated with a greater presence of delirium, longer stays, a greater requirement for complementary examinations, a greater presence of mortality and other post-surgical complications, more dependence, more risks derived from hospitalization, and a greater need for convalescence after discharge.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 65 years of age admitted to the Short Stay Unit

Exclusion Criteria:

* Patients under 65 years of age admitted to the Short Stay Unit
CETI-ANKLE: Cetilar®️ in Patients With Ankle Injury or Chronic Trauma to the Ankle

The purpose of this study is to assess the safety, tolerability and efficacy of Cetilar®

After being informed about the study, all patients giving written informed consent will undergo no more than a 1-week screening period to determine eligibility for study entry. Patients that meet inclusion criteria and do not have exclusion criteria will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to Cetilar® cream (about 5 g, twice per day) or placebo cream (about 5 g, twice per day).

Eligibility Criteria:
Inclusion Criteria:

1. Signing the Patient Information Sheet and Informed Consent Form
2. Patients with reduced ankle mobility caused by injury or chronic trauma to the ankle
3. Men or women aged ≥20 and ≤80 years
4. Patients who mark the pain 4 cm on a VAS
5. Patients who are willing or able to follow doctor's instructions
6. Patients not participating in other clinical trials within 30 days before the screening
7. Patients who have received sufficient explanation for this clinical trial and agreed to participate

Exclusion Criteria:

1. Patients who received intraarticular injection treatment into the painful area within 3 months prior to the first visit
2. Ankle surgery in the previous six months
3. Topical NSAIDs application during the treatment period
4. BMI \> 32
5. Systemic inflammatory diseases (e.g. fibromyalgia, etc.)
6. Progressive serious medical conditions (such as cancer, AIDS or end-stage renal disease)
7. Patients with major infections in the observation period
8. Renal diseases (serum creatinine concentration more than 1.2 times the upper limit of the normal range according to the central laboratory definition reference values)
9. Liver dysfunction (serum alanine or aspartate transaminase concentrations more than 1.5 times the upper limit of normal range)
10. Patients with serious heart-related diseases such as cardiac arrest, a history of cerebral infarction, or ischemic heart disease
11. Patients who received systemic steroid treatment within 1 month prior to their first visit
12. Diabetic foot
13. Pregnant or lactating women
Weight Changes During and After Pregnancy in Women With Gestational Diabetes

Gestational diabetes mellitus (GDM) is associated with short-term and long-term complications for infants and mothers. The management of GDM during pregnancy focuses on reducing risks to the infant associated with hyperglycemia. The postpartum management of GDM focuses on reducing maternal risk of developing type 2 diabetes (T2DM). A diagnosis of GDM identifies up to 31% of parous women who will eventually develop T2DM and approximately 50% of women diagnosed with GDM will develop T2DM in the first 5 years postpartum. The perceived risk of developing short-term and/or long-term complications of GDM may influence women's likelihood of engaging in diet modification, the mainstay of treatment of GDM, both during and after pregnancy. If sustained after delivery, diet modifications introduced as treatment for GDM could affect maternal weight changes during and after pregnancy, which could in turn affect T2DM risk. It is unknown if and how women with GDM differ in their perceived risk of developing T2DM, dietary choices, or weight gain (and retention) during versus after pregnancy. Therefore, the project proposed in this application seeks to (1) characterize the perceived risk of developing T2DM among women with GDM during and after pregnancy, (2) characterize dietary choices of women with GDM during and after pregnancy, and (3) characterize weight changes of women with GDM during and after pregnancy as compared to women without GDM.


Eligibility Criteria:
Inclusion Criteria for women with GDM:

* Patient is currently pregnant with a singleton pregnancy.
* Laboratory confirmed diagnosis of GDM between weeks 24-28 gestation.
* Patient is receiving routine prenatal care at Vanderbilt University Medical Center.

Inclusion Criteria for women without GDM:

* Patient is currently pregnant with a singleton pregnancy.
* Patient does not have GDM based on non-fasting and/or fasting GTT results.
* Patient is receiving routine prenatal care at Vanderbilt University Medical Center.

Exclusion Criteria for both cohorts:

* Diagnosis of type 1 or type 2 diabetes prior to pregnancy.
* Diagnosis of GDM prior to 20 weeks gestation.
* Patient does not speak English.
Comparison Between Biopsied and Non-biopsied Intracytoplasmatic Sperm Injection (ICSI) Embryos and Natural Pregnancy Embryos

As Pre Implantation Genetic Screening (PGS) becomes now a replacement modality and trend gaining popularity among physicians and patients on claiming its ability to settle on the simplest genetically normal embryo, so it had been logical to review if taking cells from the embryo in its early development will or won't affect its growth as compared to the previous standard technique of ICSI and in comparison to a normally conceived embryos the study also will question if the parameters of the prenatal biochemical standard parameters will have any differences if the embryo is already genetically tested embryo and compare these parameters with non PGS embryos and normally conceived embryos.

This study is an ambispective, comparative, cohort, observational, single-center study.

The study participants' relevant medical records will be collected and reviewed for the retrospective subjects and after obtaining informed consent for the prospective subjects. The study materials that will be used will include blood tests and ultrasound. The study will involve three study arms

This study is an ambispective, comparative, cohort, observational, single-center study that will be conducted at Wael ElBanna Clinic, a private center that is well equipped for all procedures needed for ICSI and fetal medicine. After obtaining informed consent, the study participants' relevant medical records will be collected and reviewed. Data will be collected from the subjects' medical records. Data will be pooled and presented in aggregate, without identification of individual subjects.

The study materials that will be used will include blood tests and ultrasound. The study will involve three study arms:

* Arm 1: biopsied ICSI embryos (PGS)
* Arm 2: none biopsied ICSI embryos
* Arm 3: natural pregnancy embryos

Eligibility Criteria:
Inclusion Criteria:

1. Singleton pregnant women
2. Pregnancy confirmation by ultrasound at week 6 of gestation either by normal pregnancy or ICSI (Biopsied and Non-Biopsied)
3. Between the age of 20 and 40 years.
4. Non-smokers.
5. BMI must be between 19 and 40

Exclusion Criteria:

1. Those with anti-phospholipid syndrome confirmed by serological tests
2. Those with any hematological and immunological disorders
3. Women with uterine abnormalities have not been corrected.
4. Women with systemic diseases that cannot be controlled or managed