cyrilzakka/clinical-trials huggingface dataset:
The Prediction of Extent and Risk Profile of Coronary Atherosclerosis and Their Changes During Lipid-lowering Therapy Based on Non-invasive Techniques

* The prediction of extent and risk profile of coronary atherosclerosis based on clinical evaluation and non-invasive techniques.
* Detailed analysis of plaque volume, plaque composition, risk plaque features and shear stress (WSS) changes during lipid lowering therapy (rosuvastatin 40mg) from 3D vessel reconstruction.
* Prediction of changes in coronary arteries based on changes in non-invasive examinations.
* Examination of WSS influence on atherosclerosis development and changes of WSS during lipid lowering therapy.

The fundamental aim of this project is development of reliable algorithm for detection of extent and risk profile of coronary atherosclerosis based on non-invasive examinations (carotid ultrasound, examination of retinal vessel, diagnosis of endothelial dysfunction, pro-inflammatory markers including new markers of atherosclerosis and gene polymorphisms) with maximal effort on diagnosis of vulnerable plaques. The second part of the study is prediction of coronary atherosclerosis changes during high-dose lipid-lowering therapy (rosuvastatin 40 mg daily). Coronary artery impairment will be examined by up-to date technology using the fusion of angiography, intravascular ultrasound and virtual histology for 3D coronary artery reconstruction together with information about mechanical properties of arteries like a vessel shear stress. This algorithm for non-invasive assessment of coronary impairment and its changes during will be used for detection of high risk patients (in terms of acute coronary syndrome development) and of patients with low response to statin therapy. Further target is detailed assessment of atherosclerosis development and its changes during lipid-lowering therapy.

Eligibility Criteria:
Inclusion Criteria:

* stable angina pectoris

Exclusion Criteria:

* age less than 18 or more than 80
* renal insufficiency
* liver insufficiency
* pregnancy or , child potential without contraception
* intolerance of statins
* rhabdomyolysis or other myopathy in patient´s history
* acute coronary syndrome in last 6 weeks
* coronary anatomy unsuitable for intravascular ultrasound
* active cancer
Study to Assess on a Molecular Level the Influence of a 5 % Dexpanthenol Ointment in Subjects With Superficial Injuries

In previous in vitro studies it could be shown, that Dexpanthenol has an influence on the gene expression of fibroblasts. The genes which are influenced by Dexpanthenol play mainly a role during cell proliferating processes.The aim of this study is to investigate the molecular effect of Dexpanthenol on human living skin, during wound healing.


Eligibility Criteria:
Inclusion Criteria:

* Skin type I to IV
* Willingness to avoid intensive sunlight exposure two weeks before the start of the study and at least 2 months after removal of the stitches

Exclusion Criteria:

* Active skin disease, moles, tattoos, strong pigmentation at the test area or scars in the test area that would influence the visual scoring
* History of keloids and hypertrophic scars
* Frequent visits of tanning booths
* Intake of drugs interfering with the immune system (e.g. antiphlogistics, corticosteroids, immunosuppressants, and antihistamines) within 30 days before day 1 as well as during the study.
Effect of Food on the Pharmacokinetics of Apremilast (CC-10004) in Healthy Adults

The purpose of the study is to evaluate the effects of a high fat meal on the pharmacokinetics of a single dose of 30 mg apremilast in healthy adults.

Participants will be randomized to receive a single dose of 30 mg apremilast during each of the 2 periods; once under fasting conditions and once after a high fat meal. Participants will be randomly assigned to receive apremilast either fasted first, then fed, or fed first then fasted. Participants will check into the study center on Day -1 of each period, will be dosed on Day 1, and discharged from the study center on Day 3 after all scheduled pharmacokinetic blood draws and safety evaluations. After a washout of 5 to 10 days, participants will return for period 2 during which they will receive apremilast according to their assigned sequence.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male or female subjects of any ethnic origin between ages of 18 and 65 inclusive with a body mass index (BMI) between 18 and 33.
2. Females who are able to become pregnant have a negative pregnancy test at screening and baseline, and must agree to use one of the following:

   * a highly effective form of contraception (ex. Non-oral hormonal, intrauterine device) OR
   * oral hormonal contraceptive plus one additional form of barrier contraception OR
   * Two forms of barrier contraception These must be effective by the time of screening.
3. All other females must have been surgically sterilized at least 6 months prior to screening or be postmenopausal (to be confirmed by lab tests).
4. Males must agree to use latex or polyurethane condoms when engaging in sex during the study and for at least 28 days after dosing.

Exclusion Criteria:

1. Any condition, including the presence of laboratory abnormalities, or psychiatric illness, that would prevent the subject from signing the Informed Consent form, places the subject at unacceptable risk if he were to participate in the study, or confounds the ability to interpret data from the study.
2. Presence of any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism, and excretion, or plans to have elective or medical procedures during the conduct of the trial.
3. Exposure to an investigational drug (new chemical entity) within 30 days prior to the first dose administration or 5 half-lives of that investigational drug, if known (whichever is longer).
4. Subjects with known serum hepatitis, is a known carrier of hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus antibody.
5. Subjects who have used prescription systemic or topical medications within 30 days of dosing, unless it is being used to treat a stable, chronic medical condition. This includes medication that is an inhibitor or inducer of P-glycoprotein transporter and CYP-3A4/5 used within 14 days of dosing.
Tissue Monitoring During Endovascular Intervention

Tissue perfusion assessment is key to more accurate measurement of foot ischemia, which is in turn an important factor in appropriate treatment decisions. In practice though, tissue perfusion measurements are not routinely undertaken as few practical solutions exist that are easy to use and fit in everyday clinical practice. Pedra has developed a novel, easy to use, non-invasive device that can be used in practice to better inform treatment decisions.

Tissue perfusion assessment is key to more accurate measurement of foot ischemia, which is in turn an important factor in appropriate treatment decisions. In practice though, tissue perfusion measurements are not routinely undertaken as few practical solutions exist that are easy to use and fit in everyday clinical practice. Pedra has developed a novel, easy to use, non-invasive device that can be used in practice to better inform treatment decisions.

This is a feasibility study to demonstrate the ability of the Xauron system to track tissue perfusion changes in patients undergoing endovascular intervention for the treatment of peripheral artery disease (PAD). The findings of this study are for research purposes and will also be used to help with the future education of physicians about the potential use of the Xauron system. In addition, this early pilot data will be used to help power larger, more definitive studies relating to the intra-procedural use of the Xauron system.

Eligibility Criteria:
Inclusion Criteria:

* The subject is undergoing endovascular intervention for the management of their PAD.
* The subject is between 40 and 90 years of age.
* Documented lower limb arterial occlusive or stenotic disease (using ankle-brachial index / pulse volume recording, duplex ultrasound or CT angiogram) within the last 8 weeks.
* In the opinion of the Investigator, the subject is willing and able to comply with the protocol and complete all protocol assessments.
* Subject has been informed of the nature of the study, agrees to its provisions and has willingly provided written informed consent, approved by the appropriate Institutional Review Board (IRB)

Exclusion Criteria:

* Subjects on an investigational drug or being treated with an investigational therapeutic device, within 30 days of the study visit, that in the view of the Investigator might interfere with the study outcomes.
* Presence of a condition that the Investigator considers will compromise the subject's ability to participate in the study.
* Subjects on renal replacement therapy
* Signs of active infection causing localized inflammation on the plantar or dorsal surfaces of the foot.
* Diabetic subjects with a Charcot neuropathic osteoarthropathy
* Lack of intact skin, or pathological skin conditions, at the proposed sensor pad positions that may impair or prevent the adherence of medical adhesives in general.
Circulating Tumor DNA and Immunophenotyping As Potential Biomarkers with Regional Nodal Irradiation for Breast Cancer

This study will assess how radiation affects the patterns of circulating tumor deoxyribonucleic acid (ctDNA) and immune cells (T cells) during radiation treatment in patients with breast cancer. By better understanding how radiation therapy affects these markers (characteristic that is measured to see how well the body responds to a treatment for a disease) in the blood, researchers may better customize treatments for patients with breast cancer in the future.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Histologically confirmed primary or recurrent non-metastatic invasive breast cancer with plans for adjuvant post-lumpectomy or post-mastectomy radiation therapy at the Mayo Clinic and indications for regional nodal irradiation.
* Or patients undergoing curative intent irradiation for oligometastatic breast cancer (=\< 3 sites of metastases) is permitted
* Willingness to provide informed consent and expresses understanding of this protocol and its requirements, risks, and discomforts
* Patients with non-metastatic breast cancer must have completed their final breast surgery including re-excision of margins for invasive cancer and ductal carcinoma in situ (DCIS) or chemotherapy within 90 days prior to registration but no sooner than 21 days prior to the initiation of radiation therapy (RT).
* Bilateral breast cancer is permitted
* Positive or close margins is allowed

Exclusion Criteria:

* Other active malignancy =\< 2 years prior to registration (exceptions: non-melanotic skin cancer or carcinoma-in-situ of the cervix)
* Pregnancy or lactation
* Inability on the part of the patient to understand the informed consent to be compliant with the protocol
Role of Hyaluronic Acid in Bone Healing After Dental Extraction

This is a randomized controlled trial with a split mouth design. Patients with an indication of lower dental extraction will be asked to join this research project at the Department of Oral and Maxillofacial Surgery at University of Damascus Dental School. Each patient whose case requires bilateral extraction, one side will serve as an experimental side, whereas the other side will serve as a control.

Participants should have symmetric teeth that need extraction in the lower jaw. Hyaluronic acid will be injected following extraction in one of the two sides with random allocation.

cone-beam computerized tomography (CBCT) images will be taken for each participant immediately post-extraction and at six months post-operatively.

I- Clinical examination variables:

Buccolingual distance and distomesial distance will be measured for each participant at 2 assessment times: directly post-extraction and six months post-extraction.

II- Radiographic examination variables:

Linear measurements Vertical bone fill Bone mineral density

Eligibility Criteria:
Inclusion Criteria:

* 18-60 years old
* Symmetric teeth requiring extraction in the lower jaw
* Systematically healthy

Exclusion Criteria:

* Smokers
* Pregnancy (for female participants)
* Diabetic patients
* Patients with metabolic problems
The Role of the Thymus in Type I Diabetes.

Regulatory T lymphocytes play a major role in the protection from autoimmune pathology. Defects in immunosuppression mediated by these cells is therefore suspected to contribute to these diseases. This issue has very little been studied in humans.Regulatory T cells emigrated from the thymus will be isolated from the blood of patients and healthy controls. The repertoire of antigen-receptors will be analysed by high throughput sequencing and its diversity estimated using appropriate statistical models borrowed from ecology.

In the thymus of an animal model of type I diabetes, the population of regulatory T cells expresses a repertoire of antigen receptors that is approximately ten-fold less diverse than that found in mice resistant to autoimmune pathology. Genetic models later showed that this reduced diversity was involved in the susceptibility to diabetes. Researchers study the diversity of the TCR expressed by regulatory T cells from paediatric type I diabetes patients and controls. Regulatory T cells emigrated from the thymus will be isolated from the blood of patients and healthy controls. The repertoire of antigen-receptors will be analysed by high throughput sequencing and its diversity estimated using appropriate statistical models borrowed from ecology.

Eligibility Criteria:
Inclusion Criteria:

* type I diabetes patient
* having at least one age-matched sibling (healthy control)

Exclusion Criteria:

* other immunopathology
* treatment with any anti-inflammatory or immunosuppressive drugs
* puberty
* legal protection
Oral Complications in Hematological Malignancies

The aim of this study was to evaluate the prevalence and types of oral complications found in patients diagnosed with haematological malignancy

Oral lesions can be the first presentation of hematological malignancy. Dentists occasionally are the first healthcare provider that detect oral signs related to a systemic condition and thus contribute to the early diagnosis of the disease 1. Oral health can impact the progression and the outcome of haematological malignancy patients', many patients may suffer from oral infections that might affect hospital stay, treatment cost and patient prognosis 2. The oral manifestations of patients with hematological malignancy can occur due to the disease itself or as a consequence of treatment 3.

Anemia (paleness of mucosa), coagulation disorder, oral petechiae or ecchymosis, spontaneous gingival bleeding and oral infection (Ulcers and overgrowth) may be an oral manifestation of a hematologic malignancy either at diagnosis or during follow up as well as in relapse 4. The treatment of hematologic malignancy includes chemotherapy, radiotherapy, and hematopoietic stem cell transplantation (HSCT). Malignant cells are the target of antineoplastic drugs, but the oral epithelium and other cells with high mitotic rates are usually affected by the treatment. Chemotherapy and the conditioning regimen for HSCT have many adverse effects on the oral tissues depending on the type and dosage of medications 4. Oral mucositis, a common side effect of chemotherapy, causes severe pain, which is only relieved by opioids. Mucositis may appear as a generalized erythema and evolve into painful pseudomembranous ulcers. Neutropenia and thrombocytopenia are also common adverse effects of treatment, leaving patients more susceptible to oral bleeding, infections, and ulcerations. Oral mucosa pigmentation can also occur as an adverse effect of treatment 5. Considering these factors and lack of existing information, a study was designed to investigate the prevalence of oral complications problems occurring in a population of hematological malignancy patients in Assiut University Hospital.

Eligibility Criteria:
Inclusion Criteria:

* All newly diagnosed patients elder than 18 years with hematological malignancy start from January 1st 2022 to January 1st 2023 including Acute myeloid leukemia Acute lymphoblastic leukemia Chronic myeloid leukemia Chronic lymphoblastic leukemia Non-Hodgkin lymphoma Hodgkin lymphoma Multiple myeloma

Exclusion Criteria:

* Patient younger than 18 years old Patients previously diagnosed Patients refused to participate in our study
Reducing Traffic Pollution Exposure Improves Blood Pressure

This randomized trial assessed the effect of modifying building envelop and level of air filtration on blood pressure over two hour exposure sessions.

Living close to major roadways is associated with elevated blood pressure (BP) amongst other adverse health effects. There is growing evidence that ultrafine particles (UFP, \<100 nm in diameter), which are elevated near major roads and highways, contribute to such risks. We assessed the efficacy of high efficiency particulate arrestance (HEPA) filtration and building envelope adjustment at reducing exposure to and health effects of air pollution next to major highways.

We used a randomized three-period crossover trial design to assign 77 participants (aged 40-75 and without diagnosis of hypertension) to three two-hour exposure sessions. Sessions were conducted in one of two rooms immediately adjacent to highways. High, medium and low exposures were attained by varying the degree of air exchange and amount of HEPA filtration in the room. During high exposure sessions, the room was ventilated with outdoor air and no filtration was used. During low exposure sessions, leakage of outdoor air into the room was minimized and HEPA filtration was maximized. During medium exposure sessions, a moderate amount of HEPA filtration was used (less than half of that used in low sessions). Indoor particle number and black carbon (BC) concentrations (i.e., markers of traffic-related air pollution) were monitored continuously.

During each session participants sat quietly and wore noise-cancelling headphones, while their BP was monitored every ten minutes using an ambulatory BP monitor. We monitored pulse and oxygen saturation continuously.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criterion was age 40-75 years.
* There was a preference for people who were otherwise healthy, but overweight or obese.

Exclusion Criteria:

* A history of a major cardiovascular outcome (including myocardial ischemia (MI), stroke, angina)
* Other serious health problems (current asthma or COPD)
* Taking anti-hypertensive medications
* Smoking or living with a smoker
* Cognitive impairment
* Working at a job with high combustion exposure (taxi/truck driver, restaurant cook)
* High combustion exposure in the preceding 24 hours (driving on the highway, cooking in a restaurant, driving a truck)
* Not speaking English or Chinese.
Comparison Of Video-based Versus Written Patient Education on Sunscreen

The purpose of this study is to compare the effect of video-based patient education with written instruction on subjects' adherence to sunscreen application.

We plan to conduct a randomized, controlled trial comparing the effect of video-based patient education with written instruction on subjects' adherence to sunscreen application.

Subjects randomized to the video-based education arm will be instructed to watch a video on the importance of sunscreen application and the proper technique of applying sunscreen. Subjects randomized to the written education arm will receive written information on the importance of sunscreen application and the proper technique of applying sunscreen. The contents of the video and the written educational materials will be comparable.

At the end of the study period, 3 months later, subjects will be interviewed via telephone regarding their sunscreen application behavior during the last month of the study period. Subjects will also be interviewed regarding their comprehension and attitude towards video-based and written education materials.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older at time of consent, may be men or women.
* Able to adhere to the study visit schedule and other protocol requirements.
* Capable of giving informed consent.

Exclusion Criteria:

* Non-English speaking individuals
* Individuals with a known allergy to sunscreens
* Individuals with a history of psoriasis, because phototherapy has been shown to be beneficial for their skin condition
Intravenous rhMBL in Patients With Multiple Myeloma Receiving Chemotherapy Followed by Stem Cell Transplant

MBL deficient patients enrolled in this protocol are scheduled to be treated with melphalan-based high-dose chemotherapy followed by autologous hematopoietic stem cell transplant (HSCT) for their multiple myeloma. Patients are randomized to 0.5 mg/kg, 1.0 mg/kg, or no rhMBL.

MBL deficient patients will be randomized in a ratio of 2:2:1 to receive up to 4 weekly i.v. infusions of rhMBL at a dose of 0.5 mg/kg or 1.0 mg/kg, or standard anti-infectious prophylactic therapy alone. A total of 20 patients will be treated in each of the rhMBL arms, and 10 patients will receive best standard supportive prophylactic therapy but not rhMBL. All patients are to receive anti-infectious prophylactic supportive therapy as per institutional standards.

Eligibility Criteria:
Major Inclusion Criteria: Patients must meet all of the following criteria to be eligible for enrollment into the study:

* Capable of understanding the protocol requirements and risks and providing written informed consent.
* Histologically or cytologically confirmed diagnosis of multiple myeloma.
* Mannose-binding lectin level \<300 ng/mL.
* Age ≥18 years old.
* Score of 0 to 2 on the Zubrod performance status scale.
* Patient is scheduled to receive melphalan-based high-dose chemotherapy and autologous HSCT for the treatment of multiple myeloma.

Exclusion Criteria:

* Concurrent serious medical illness that could potentially interfere with protocol compliance.
* Concurrent or previous malignancy associated with a poor prognosis.
* Known chronic infectious disease, such as acquired immunodeficiency syndrome (AIDS) or hepatitis (for hepatitis and human immunodeficiency virus \[HIV\] will not be performed).
* Positive screening pregnancy test or is breast-feeding.
* Female or male patient of reproductive capacity unwilling to use methods appropriate to prevent pregnancy during the course of this protocol.
* Known or clinically suspected active brain metastases.
* Current participation in another clinical study with an investigational agent and/or use of an investigational drug.