cyrilzakka/clinical-trials huggingface dataset:
Singlet Oxygen Quantification After Skin Exposure to Ultraviolet A (UVA) Light

The objective of this study is quantification of singlet oxygen species in the skin after exposure to Ultraviolet A (UVA) light

Ultraviolet (UV) radiation can lead to skin damage and cancer. Ultraviolet A (UVA) irradiation is 10 to 100 times more abundant in natural sunlight than ultraviolet B (UVB), thus human skin is exposed to more UVA irradiation daily.UVA irradiation is not completely filtered by clothing and it penetrates deeper into the dermis than UVB, potentially causing more damage. It is believed that skin cancer, photo aging, and skin immunomodulation are mediated by the reactive oxygen species (ROS) that are generated in response to UV radiation. Singlet oxygen (1O2) is one type of ROS. The aim of this study is to quantify the level of singlet oxygen generated in the skin after exposure to UVA radiation. Previous studies have used low dose ultraviolet A1(UVA1) irradiation of 20 J/cm2, which mimics exposure to strong sunlight of approximately two hours. This study will use UVA doses equivalent to or less than what humans are exposed to in daily life. Additionally, the aim is to quantify singlet oxygen produced in individuals of various skin types before and after application of sunscreens containing zinc oxide and avobenzone (sun protection factor 30). To our knowledge, there is no method for quantifying singlet oxygen in human skin after exposure to UVA light. This is a novel method that may help the investigators understand further the protective effects of various skin types, as well as sunscreens.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 18 years and older

Exclusion Criteria:

* Those who are currently smoking or have smoked within the past 3 years.
* Aspirin use
* Multivitamins and supplements that contain vitamin E
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
Treatment of Optic Neuropathies Using Autologous Bone Marrow-Derived Stem Cells

A single arm, single center trial to assess the safety and efficacy of restoring function in damaged optic nerves using autologous purified populations of bone-marrow derived stem cells (BM-SCs) through a 24 month follow up period.

Optic nerve atrophy (ONA) is a condition defined as a damage to the optic nerve that harmfully affects central and peripheral vision. ONA may occur as a result of optic neuritis, compression by tumors or aneurysms, toxic and nutritional neuropathies, trauma, or as a secondary complication to other systemic diseases such as diabetes. Symptoms of ONA vary diversely, but mainly include blurred vision and a reduction in optic sharpness and color visualization. ONA is irreversible process, and current medical strategies focus on finding the underlying cause, and trying to prevent further vision loss and protect the other healthy eye. This is a Single arm, Single Center trial to assess the safety and efficacy of purified adult autologous bone marrow derived CD34+, CD133+, and CD271+ stem cells through a 24 month follow-up period. The combination of these three cell types was based on their diverse potentialities to differentiate into specific functional cell types to regenerate damaged optic nerves and supporting issues and vasculature, and the availability of clinical-grade purification system (CliniMACS) and Microbeads to purify the target cell populations in clinically-approved methods. Anticipated outcomes of this study are defined in an overall improvement of vision, restoration of functions to damaged optic nerves, and improvement in quality of life of patients.

Eligibility Criteria:
Inclusion Criteria:

* Patient should suffer from Optic Nerve Atrophy diseases like diabetic retinopathy and retinal pigmentation.
* Age in between 18-55 years old
* Willingness to undergo bone marrow derived autologous cell therapy.
* Ability to comprehend the explained protocol
* Ability and willingness to regularly visit to hospital for protocol and follow up

Exclusion Criteria:

* Patients with preexisting or current systemic disease such as lung, liver, gastrointestinal, cardiac, immunodeficiency, syphilis, or clinically relevant polyneuropathies.
* History of life threatening allergic or immune- mediated reaction
Effect of Remote Ischemic Preconditioning on Lung Injury After Pulmonary Resection

The purpose of this study is to determine whether ischemic preconditioning reduces lung injury in patients undergoing pulmonary resection.

Remote ischemic preconditioning is an intervention in which brief ischemia of one tissue or organ protects remote organs from a sustained episode of ischemia. It is known that one-lung ventilation in patients undergoing pulmonary resection, which may cause acute lung injury. The investigators did a single-blinded randomised controlled study to establish whether remote ischemic preconditioning reduces lung injury in these patients.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of pulmonary carcinoma
* Must be received pulmonary lobectomy

Exclusion Criteria:

* Cardiac disease categorized as NYHA classes II-IV
* Preoperative severe impairment of respiratory function (arterial oxygen tension (PaO2) \<60 mmHg or FEV1\<50% predicted),
* Pre-existing coagulopathy or thrombocytopenia
* Prior receipt of chemotherapy or radiation therapy or immunotherapy
* Systemic or local active infections (either clinically defined or suggested by evidence such as elevated C-reactive protein levels, leukocytosis, or a body temperature\>38℃)
* Peripheral vascular disease affecting the upper limbs
* Administration of vitamins, nonsteroidal anti-inflammatory agent or corticosteroid within 3 months.
Bioavailability of Bimatoprost Ophthalmic Solution in Human Aqueous.

The purpose of this study is to assay human aqueous for bimatoprost and the presence of any metabolites, especially prostaglandin analogs. Hypothesis:Bimatoprost is not metabolized to a prostaglandin F-2-alpha analog in human eyes

* Bimatoprost levels in human aqueous peak approximately three hours post dosing

The purpose of this study is to assay human aqueous for bimatoprost and the presence of any metabolites, especially prostaglandin analogs

Eligibility Criteria:
Inclusion Criteria:

* All subjects must:

  1. Be willing and able to provide written Informed Consent.
  2. Be able and willing to follow instructions and likely to complete the entire course of the study.
  3. Be male or female of any race at least 18 years of age.
  4. Have visually significant cataract for which they have elected to undergo cataract surgery..

Exclusion Criteria:

* No subject may:

  1. Have any contraindication to use of a prostaglandin analog or prostamide derivative.

  3. Have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study parameters (such as: uveitis, ocular infection, or severe dry eye). Patients with mild chronic blepharitis, age-related macular degeneration, background diabetic retinopathy may be enrolled at the discretion of the investigator.

  4. Have laser or any other intraocular surgery within the past three months. 5. Require use of ocular medications (including glaucoma medications), except intermittent use of artificial tears. Patients may not have a history of ever having used a prostaglandin analog topically.

  6. Have known allergy or sensitivity to the study medications or their components 7. Have corneal abnormalities that would interfere with the ability to obtain an adequate sample safely or have a shallow anterior which would make obtaining an aqueous sample difficult at the time of surgery in the opinion of the investigator.

  8. Be concurrently enrolled in an investigational drug or device study or participation within the last 30 days in any investigational drug or device study.

  9. Be pregnant, nursing, planning a pregnancy, or be of childbearing potential and not using a reliable form of contraception (a woman is considered of childbearing potential unless she is postmenopausal, has had a uterus and/or both ovaries removed, or has had a bilateral tubal ligation).

  10. Have a situation or condition that in the investigator's opinion may put the subject at significant risk, may confound the study results, or may interfere significantly with participation in the study.
Randomized Study of ABC-14 Regimen Compared With "3+7" Standard Induction Therapy or AB-14 for ND AML

To compare the efficacy and safty of ABC-14 regimen with the traditional "3+7" regimen or AB-14 regimen in the treatment of newly diagnosed acute myeloid leukaemia

Acute myeloid leukemia (AML) is a clonal malignant blood disease with genetic heterogeneity and originated from hematopoietic stem progenitor cells.In the past 50 years, the "3+7" induction regimen represented by cytotoxic drugs (including anthracyclines/anthraquinones combined with cytarabine) has remained the standard induction regimen for newly diagnosed AML patients with intensive chemotherapy. In AML patients \<60 years old, the "3+7" regimen induces a complete response rate of 60% to 80%, but the treatment-related mortality is as high as 13%, and more than half of the patients face the threat of relapse, and the 5-year overall survival rate is about 35% to 40%.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with AML (the diagnostic criteria refer to WHO2022 standard, non-APL), and have not received systemic anti-leukemia therapy (except hydroxyurea, low-dose cytarabine and other tumor reduction pretreatments);
2. Age ≥18 years old;
3. ECOG≤4;
4. The fertile woman agrees to use effective contraception during the treatment period and up to 3 months after the end of the treatment; Sign the informed consent form.

Exclusion Criteria:

1. Known history of allergy to the investigational drug;
2. Resistance to azacytidine, azacitidine, Venetoclax;
3. Inability to take oral medication;
4. Combined with uncontrolled active infections (including bacterial, fungal or viral infections);
5. Combined with uncontrolled major organ dysfunction: cardiac insufficiency, decompensated liver insufficiency, moderate/severe renal insufficiency, etc.;
6. Participating in other clinical studies that affect the main purpose of this study; Patients deemed unsuitable for participation in this study.
LANDMARK Trial: a Randomised Controlled Trial of Myval THV

The primary objective of this study (LANDMARK) is to compare the safety and effectiveness of the Myval THV Series with Contemporary Valves (Sapien THV Series and Evolut THV Series) in patients with severe symptomatic native aortic valve stenosis.

This study will be done in total 768 subjects (384:384, Myval THV Series vs. Contemporary Valves)

The randomisation will be carried out with an allocation ratio of 1:1 between Myval THV Series vs. Contemporary Valves (Sapien THV Series and Evolut THV Series)

LANDMARK Trial is a prospective, randomised, multinational, multicentric, open-label non-inferiority trial of total 768 subjects (384:384, Myval THV Series vs. Contemporary Valves) with severe symptomatic native aortic valve stenosis via transfemoral approach.

* Device sizes applicable for the Myval THV Series: 20 mm, 21.5 mm, 23 mm, 24.5 mm, 26 mm, 27.5 mm, and 29 mm diameter.
* Device sizes applicable for the Sapien 3 THV Series: 20 mm, 23 mm, 26 mm, and 29 mm diameter.
* Device sizes applicable for the Evolut THV Series: 23 mm, 26 mm, 29 mm, and 34 mm diameter.

A non-randomised nested registry will be conducted to include patients requiring extra-large size of Myval THV series (XL Nested Registry)

- Device sizes applicable for the XL Nested Registry: 30.5 mm and 32 mm.

A non-randomized registry will include patients implanted with the Myval THV Series (Lead-in Set).

- The investigators have to perform a minimum of 2 lead-in cases (non-randomised) under the guidance of the lead-in evaluation committee.

Eligibility Criteria:
Inclusion Criteria:

1. Patient ≥18 years of age.
2. Patient or their legal representative has provided written informed consent as approved by the Institutional Review Board (IRB)/Institutional Ethics Committee (IEC) of the investigational site to participate in the study.
3. As per local Heart Team assessment, patient is eligible for TAVI and the patient is suitable for implantation with all three study devices.

Exclusion Criteria:

1. Patients who are not willing to provide informed consent form, or whose legal heirs object to their participation in the study.
2. Any condition, which in the Investigator's opinion, would preclude safe participation of patient in the study.
Risk and Protective Factors for Relapse to Alcohol Use in Patients With Liver Disease Undergoing Liver Transplantation

This is an observational, monocentric study, consisting of both a retrospective and a prospective component. The aim of the study is to identify risk and protective factors for alcohol relapse in patients with alcohol-related liver disease (ARLD) who have undergone orthotopic liver transplantation (OLT).

For the retrospective part of the study, clinical data will be collected and analyzed from patients diagnosed with ARLD and with components of exotoxicity who underwent liver transplantation in the past five years. This data will be obtained from patient medical records, including results from laboratory tests and multidisciplinary outpatient consultations conducted as part of routine clinical practice.

The prospective phase of the study will involve the consecutive enrollment of patients diagnosed with ARLD or with exotoxicity-related etiological components who are undergoing liver transplantation at the IRCCS AOUBO. Four patient assessment points are planned, which will take place during routine follow-up visits already scheduled as part of the patient's care pathway. During these visits, data will be collected on the patient's medical history, laboratory and/or histological results, as well as diagnostic and surgical information. Additionally, through the administration of clinical questionnaires, data will be gathered on the patient's psychiatric-psychological status, history of exotoxicity, and psychosocial background.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have signed the informed consent
* Candidates for liver transplantation due to liver disease with alcohol-related etiology (either mono- or multifactorial)
* For the retrospective part: patients who underwent OLT for ARLD during the time frame 2017-2022

Exclusion Criteria:

* Major psychopathologies and active psychoses
A Clinical Trial of Ginseng in Diabetes

a clinical study of Ginseng its potential affect on diabetes

Comparing three groups (those with \& without normal blood sugar levels) to see if there is any clinically significant change in blood sugar levels in relationship to those taking:

1. ginseng
2. ginsenoside RE (a type of metabolized ginseng)
3. placebo

Eligibility Criteria:
Inclusion Criteria:

* ages 18-65
* healthy, non-diabetic
* healthy, impaired glucose tolerance/mild diabetes (no medications required)

Exclusion Criteria:

* impaired glucose tolerance (borderline diabetes that requires medications)
* diabetes (requiring medications)
* caffeine sensitivity
* known cardiac, peripheral vascular diseases
* arrhythmias (irregular heart rhythms)
Lung and Systemic Inflammation in the Critically Ill Patient

Acute respiratory distress syndrome (ARDS) is a devastating form of acute lung inflammation, that may be caused by a variety of insults with pulmonary and systemic infectious disease being the most common predisposing factor. Sepsis, on the other hand, represents the systemic inflammatory response to an invading pathogen, which may inflict damage upon the host through organ dysfunction. ARDS and sepsis are heterogenous clinical conditions that have a high mortality, and both diseases involve a complex interplay of different inflammatory mediators and cell types. It has been suggested that locally released inflammatory mediators pass from the lungs into the bloodstream following ARDS, triggering systemic inflammation. Conversely, it is possible that severe systemic inflammation may lead to ARDS by an influx of inflammatory mediators from the bloodstream to the lungs. However, the time course and the possible pathways for this transmission of disease have yet to be established.

Investigators hypothesize that:

1. Primary systemic inflammation is followed by a secondary pulmonary inflammatory response
2. Primary pulmonary inflammation is followed by a secondary systemic inflammatory response
3. Both primary and secondary inflammatory responses are characterized by the appearance of pro-inflammatory cytokines, inflammatory cells and production of collagen-like proteins (termed 'lectins')
4. The inflammatory response is most pronounced in the primary afflicted compartment.


Eligibility Criteria:
Inclusion Criteria:

General:

* Age \>18 years
* Mechanically ventilated
* \< 48 hours after admission to the Intensive Care Unit

Specific:

-ARDS: acute (\< 1 week) respiratory failure, characterized by hypoxemia (PaO2/FiO2 \< 300 mmHg/40kPa), and bilateral infiltrates on x-ray or CT of thorax, that can not be explained by heart failure og overhydration.

OR

- SIRS (two of the following): Temperature \> 38°C or \< 36°C, heart rate \> 90/min, respiratory frequency \> 20 or PaCO2 \< 4.2 kPa, leukocytosis (\> 12x10\^9/L) or leukopenia (\< 4x10\^9/L)

OR

ARDS + SIRS

Exclusion Criteria:

One lung ventilation; Tube size \< 8.0 mm; INR \> 1.5 or thrombocytes \< 40x10\^9/L; Intracranial hypertension; Malignant arrythmias
Study of Darbepoetin Alfa for the Treatment of Anemia of Cancer

The purpose of this study is to evaluate the efficacy of darbepoetin alfa versus placebo in reducing the occurrences of red blood cell transfusions in subjects with anemia of cancer who are not receiving chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* subjects with non-myeloid malignancies
* anemia due to cancer
* ECOG status 0 to 2
* greater than or equal to 4-month expectancy
* greater than or equal to 18 years and of legal age for informed consent
* screening hemoglobin concentration less than or equal to 11.0g/dL
* adequate serum folate and vitamin B12
* adequate renal and liver function
* written informed consent

Exclusion Criteria:

* subjects currently receiving or planned to receive cytotoxic chemotherapy or myelosuppressive radiotherapy during the study or within 4 weeks before randomization
* in complete remission, as determined by the investigator
* subjects who have other diagnoses not related to the cancer which cause anemia (eg. gastrointestinal bleeding, renal disease, etc)
* documented history of pure red cell aplasia
* Known history of seizure disorder
* cardiac condition: uncontrolled angina, congestive heart failure, known ejection fraction less than 40%, or uncontrolled cardiac arrhythmia
* uncontrolled hypertension
* clinically significant systemic infection or chronic inflammatory disease present at the time of randomization
* iron deficiency
* known positive test for HIV infection
* previously suspected of or confirmed to have neutralizing antibodies to rHuEPO or darbepoetin alfa
* received rHuEPO or darbepoetin alfa therapy within 4 weeks of randomization
* less than 30 days since receipt of any investigational drug or device that is not approved by the applicable regulatory authority
* pregnant or breast feeding
* subject of reproductive potential who is not using adequate contraceptive precautions
* known hypersensitivity to mammalian-derived product or any other ingredients in the investigational product
* previously randomized into this study
* concerns for subject's compliance with the protocol procedures
Hyperbaric Versus Normobaric Oxygen Therapy for COVID-19 Patients

At least 1 in 6 COVID-19 patients admitted to hospital to receive extra oxygen will die of complications. In patients with COVID-19, invasive treatment such as mechanical ventilation (e.g. breathing with a machine) is associated with a 50% increased risk of death. Invasive treatments use a lot of healthcare resources in intensive care units and may lead to further deaths if patients do not have access to care.

The investigators aim to improve outcomes for COVID-19 patients by implementing hyperbaric oxygen therapy (HBOT). HBOT allows patients to breathe 100% oxygen in a special chamber at a pressure higher than sea level. It is approved by Health Canada for 14 conditions. HBOT is safe when administered by experienced teams.

There are two main causes of death in severe COVID-19 respiratory infections: (i) a decreased diffusion of oxygen from the lungs to the blood and (ii) an increased inflammatory response (also called a "cytokine storm"). HBOT leads to increased oxygen level in blood, has strong anti-inflammatory effects, and may destroy the virus responsible for COVID-19 disease. The initial experience with HBOT and COVID-19 from China, France and the United States is promising in that it prevents further worsening of the condition and need for intensive care.

The investigators propose to test the effectiveness of HBOT for COVID-19 patients who are admitted to hospital to receive extra oxygen. Using the most rigorous and innovative research methods, this Canadian-led international study will operate at 5 centers across 3 countries (Canada: Ottawa, Toronto, Edmonton; Switzerland: Geneva; UK: Rugby/London). The investigators anticipate that when treated by HBOT, COVID-19 patients needing extra oxygen to breathe will see significant health improvements as well as a decrease in complications, inflammation in the blood, need for invasive care, death, and cost of care.


Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant female patients
* Age ≥18 years
* Confirmed COVID-19 positive by RT-PCR or another validated method
* Diagnosed with pneumonia requiring 21%\<FIO2≤100% to maintain saturation by pulse oximetry (SpO2) ≥90%
* Able and willing to comply with study procedures and follow-up examinations contained within the written consent form

Exclusion Criteria:

* Patient clinical status felt to be incompatible with HBOT, e.g. respiratory failure requiring mechanical ventilation
* Pregnancy, determined by a serum or urine test
* Hemodynamic instability requiring vasopressors
* Inability to maintain a sitting position during treatment
* Inability to effectively understand and communicate with the hyperbaric operator, or to give consent
* Inability to spontaneously equalize ears and refusal of myringotomies
* Contraindications to HBOT (e.g. pneumothorax)