cyrilzakka/clinical-trials huggingface dataset:
VOLtage-based Contrast Media AdaptatioN in Coronary Computed Tomography Angiography

The purpose of this study is to prospectively evaluate the effectiveness of low-volume contrast media (CM) injection protocols adapted to tube voltage in patients undergoing Coronary Computed Tomography Angiography (CCTA).


Eligibility Criteria:
Inclusion Criteria:

1. Referred for a clinically indicated CCTA scan.
2. Subject must be 18 - 85 years of age.
3. Subject must provide written informed consent prior to any study-related procedures being performed.
4. Subject must be willing to comply with all clinical study procedures.

Exclusion Criteria:

1. Subject is a pregnant or nursing female. Exclude the possibility of pregnancy:

   * By testing (serum or urine beta HCG) within 24 hours before study agent administration, or
   * By surgical sterilization, or
   * Post-menopausal, with minimum one (1) year history without menses.
2. Subject is chosen by the automated tube voltage selection algorithm (or adjusted by the technologist) to be scanned using a tube voltage that is not 70, 80, 90, 100, 110, 120, or 130 kV.
3. Subject is chosen by the automated tube voltage selection algorithm (or adjusted by the technologist) to be scanned using a tube voltage that has previously reached the maximum subject number (20 subjects per tube voltage).
4. Subject has an acute psychiatric disorder.
5. Subject is unwilling to comply with the requirements of the protocol.
6. Subject has previously entered this study.
7. Subject has an allergy against iodinated contrast agents or pharmaceutical stressors used in this study.
8. Subject has impaired renal function (creatinine \> 1.5 mg/dl).
9. Subject is in unstable condition.
Prospective Trial to Reduce Morbidity and Mortality After Lung Surgery in Patients With Reduced Pulmonary Capacity

A fast track recovery program (thoracic epidural anesthesia, carbohydrate drink preoperative, early removal of chest tubes) is evaluated compared to conventional perioperative treatment (patient controlled analgesia, no carbohydrate drink preoperative) in patients with FEV1 \< 70% of expected value or \< 1.5L who undergo resections of the lung.


Eligibility Criteria:
Inclusion Criteria:

* resection of the lung
* FEV1 \<70% of expected value or below 1.5L
* 18-80y
* given written informed consent

Exclusion Criteria:

* contraindication for epidural anesthesia
* prio ipsilateral thoracotomy
* chemotherapy \<6 weeks prior to study enter
* existing pneumonia (fever, elevated WCC, elevated CRP)
Evaluation of Objective Outcomes With the Use of an Activity Tracker During the Trial Period of Spinal Cord Stimulation

For this study the investigators will conduct five-day trial periods for spinal cord stimulator (SCS) effectiveness-once a patient is deemed to be a possible SCS candidate, the trial leads are implanted and they are asked to return to clinic in five days to evaluate the effectiveness of the trial. The primary outcome for this study will be a comparison of daily energy expenditure (EE), in units of kcal/day, prior to and after the trial implantation of the SCS leads and external pulse generator. Patients will wear the accelerometer device twenty-four hours a day for five days prior to the trial lead implantation to obtain baseline values, have the trial leads implanted in the procedure clinic, then continue to wear the accelerometer for another five days. Baseline and post-SCS energy expenditure values will be compared. The secondary outcomes for this study will be steps taken, hours of sleep, and Oswestry Disability Index (ODI, as described in appendix 1) during the pre and post trial implantation periods. SCS itself is not a research procedure in this study, rather it is part of routine medical care for patients who would benefit from the procedure.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting to the UCD chronic pain clinic with post-laminectomy syndrome and demonstrate signs of neuropathic axial back pain will be considered.

Exclusion Criteria:

* Adults unable to consent, individuals who are not yet adults, pregnant women, patients unable to stop anticoagulation, and prisoners will be excluded.
* Pregnant patients will be excluded due to the risks of radiation exposure during SCS procedures and prisoners will be excluded as our clinic does not receive referrals from prison populations at this time.
Changes in Alveolar Macrophage Function During Acute Lung Injury

In this study, the investigators aim to observe the change in alveolar macrophage function during acute lung injury.

Alveolar macrophages are tissue-resident or recruited cells with key functions in recognition of pathogens, initiation of host defensive ang protective inflammation,and in clearance of pathogens from the airways. However, macrophages are also responsible for efficient clearance of apoptotic neutrophils, termed efferocytosis, which is a prerequisite for the timely resolution of inflammation. In this study, the investigators aim to observe the change in alveolar macrophage function during acute lung injury.

Eligibility Criteria:
Inclusion Criteria:

* Patients in ICU with diagnosed ALI under mechanical ventilation

Exclusion Criteria:

* Patients with cardiac dysfunction, using steroid drugs or other drugs can that affect efferocytosis
An Expanded Access Study of Brigatinib for Patients With ALK-positive Advanced Non-Small Cell Lung Cancer

The purpose of this study is to provide brigatinib for those patients with locally advanced and/or metastatic patients with ALK+ NSCLC on an expanded access basis due to their inability to meet eligibility criteria for on-going recruiting trials, inability to participate in other clinical trials (e.g., poor performance status, lack of geographic proximity), or because other medical interventions are not considered appropriate or acceptable.


Eligibility Criteria:
Inclusion Criteria:

1. Have histologically or cytologically confirmed locally advanced or metastatic NSCLC that is determined to have an ALK-rearrangement detected according to local standard procedure.
2. Resistant to or intolerant of at least 1 prior ALK TKI.
3. Recovered from toxicities related to prior anticancer therapy to NCI CTCAE, v4.0) grade ≤2.
4. Are a male or female patient ≥18 years old.
5. Have adequate organ and hematologic function, as defined by the study protocol.
6. Have Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
7. Have normal QT interval on screening electrocardiogram (ECG) evaluation, defined as QT interval corrected (Fridericia) (QTcF) of ≤450 ms in males or ≤470 ms in females.
8. For female patients of childbearing potential, a negative pregnancy test must be documented prior to enrollment (\<7 days prior to the first dose).
9. Female and male patients who are fertile must agree to use a highly effective form of contraception as defined by the study protocol.
10. Must provide a signed and dated informed consent indicating that the patient has been informed of all pertinent aspects of the study, including the potential risks, and is willingly participating.

Exclusion Criteria:

1. Received an ALK TKI within 10 days prior to the first dose of brigatinib.
2. Received cytotoxic chemotherapy, investigational agents, or radiation within 14 days, except stereotactic radiosurgery (SRS) or stereotactic body radiosurgery.
3. Received prior brigatinib therapy.
4. Received monoclonal antibodies within 30 days of the first dose of brigatinib.
5. Had major surgery within 30 days of the first dose of brigatinib.
6. Have current spinal cord compression.
7. Have significant, uncontrolled, or active cardiovascular disease within 6 months prior to first dose, as defined by the study protocol.
8. Have a history or the presence of pulmonary interstitial disease, drug-related pneumonitis, or radiation pneumonitis.
9. Have a known or suspected hypersensitivity to brigatinib or its excipients.
10. Have any condition or illness that, in the opinion of the investigator, would compromise patient safety.
11. Are pregnant or breastfeeding.
12. Are eligible for and have reasonable access to participate in another ongoing brigatinib clinical study.
Investigation of the Regulation of Retinal and Choroidal Blood Vessels in Various AL Based on WF SS-OCTA Detection With Changes in Body Position

This prospective observational study aims to understand the effects of different subaxial body positions on choroidal and retinal blood vessel density. The main questions it aims to answer are as follows:1) How do retinal and choroidal blood vessels adjust and repair after changes in body position?2) Is the change of body position related to the factors that cause myopia？ 3) Are there any differences in the regulation ability of fundus blood vessels in people with different ocular axes under the condition of changes in body position?

This project will use the wide field swept-source optical coherence tomography angiography, combined with data analysis and mining methods, to explore the self-adjustment and change mode and mechanism of retinal and choroidal blood vessels in the case of posture changes in an all-round and multi-angle way. There would be three kinds of postural changes, one is 15° head-up position, one is supine position, and the other is 15° head-down position. Relevant ophthalmological measurements would be performed before and after the postural changes. The objective is to discover the three-dimensional change mode of retinal and choroid blood vessels in different postures and compare the differences among people with different lengths of ocular axes, and to elucidate the relationship between the mode and ability of retinal and choroidal blood vessels to adjust and repair changes after changes in body position and myopia, to provide more ideas and objective basis for the occurrence and development of myopia, and lay a foundation for further research. It is of great significance to innovate the pathogenesis of myopia, deepen the theoretical understanding, and guide the prevention and control of myopia.

Eligibility Criteria:
Inclusion Criteria:

1. Corrected visual acuity ≥1.0 (international standard visual acuity chart);
2. Age 10-40 years old;
3. In good health;
4. Give informed consent and volunteer for the study. The process of obtaining informed consent complies with GCP regulations.

Exclusion Criteria:

1. Can not cooperate with the completion of relevant inspection and data collection;
2. Pregnant and lactating women;
3. Patients with amblyopia, glaucoma, retinitis pigmentosa, senile macular degeneration, retinal artery obstruction, retinal vein obstruction, diabetic retinopathy and other eye diseases that may affect the blood circulation and vascular diameter of the retina and vein, or those who have undergone intraocular surgery;
4. Patients with cardiovascular and cerebrovascular diseases, endocrine diseases, autoimmune diseases;
5. Long history of smoking and drinking;
6. History of ocular trauma;
7. The mentally ill;
8. Those who have taken drugs that affect blood circulation in the past 3 months;
Study of BK1301 (DTaP Vaccine) as a Booster in Adolescents

This study is designed to assess the immunogenicity and safety of DTaP vaccine (BK1301) as a booster dose in adolescents.

The purposes of this study are as follows:

* To confirm the non-inferiority of BK1301 to Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid) with respect to booster responses for anti-diphtheria toxoid (anti-D) and anti-tetanus toxoid (anti-T) antibodies
* To confirm that booster responses for anti-pertussis toxoid (anti-PT) and anti-Filamentous Hemagglutinin (anti-FHA) antibodies are more than 80% of participants received BK1301


Eligibility Criteria:
Inclusion Criteria:

* Age 11 or 12 years on the day of injection
* Received 3 or 4 doses of DTaP vaccine

Exclusion Criteria:

* History of pertussis, diphtheria, tetanus
* History of anaphylaxis to vaccine components
* Serious conditions or diseases of the heart, vein, blood, respiratory, hepar, kidney, digestive system, psychiatric or nervous system
* Transfused or received gamma globulin within 3 months, or received high-dose gamma globulin within 6 months before the day of injection
Study of Acalabrutinib and Rituximab in Untreated Elderly and/or Frail Patients With DLBCL

The study will measure the safety, tolerability, and efficacy with acalabrutinib in combination with rituximab in treatment-naïve elderly and/or frail patients with diffuse large B-cell lymphoma (DLBCL), who are otherwise unsuitable for standard front line chemoimmunotherapy treatments.

Treatment-naïve elderly and/or frail patients with DLBCL will be treated with acalabrutinib in combination with rituximab in a single arm.

Study details include the following:

* The study duration will be up to 108 weeks for each patient, including up to 28 days for screening and 104 weeks of treatment and follow-up.
* The treatment duration will be up to 8 cycles for rituximab and 28 cycles for acalabrutinib both beginning at cycle 1.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 80 years of age at the time of screening, or
* ≥ 65 to 79 years of age at the time of screening and considered ineligible for chemoimmunotherapy
* Histologically documented DLBCL
* No prior treatment for DLBCL
* Stage II, III, or IV disease by the Ann Arbor Classification .
* Eastern Cooperative Oncology Group performance status of 0, 1, or 2 with no deterioration over the previous 2 weeks prior to baseline or day of the first dosing except when due to underlying lymphoma.
* At least 1 lesion that can be accurately measured at baseline as ≥ 10 mm in the longest diameter with computed tomography or magnetic resonance imaging and is suitable for accurate repeated measurements.
* Adequate organ and marrow function independent of growth factor or transfusion support within 1 week of Screening.

Exclusion Criteria:

* Any evidence of diseases (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, renal transplant, and active bleeding diseases), that would make the study undesirable for the patient or that would impact compliance with the protocol.
* History of prior or current malignancy, that would affect compliance with the protocol or interpretation of the results.
* Serologic status reflecting active hepatitis B or C infection.
* Serological positivity or known infection with HIV.
* Active central nervous system involvement by lymphoma, leptomeningeal disease, or spinal cord compression.
* Any comorbidity or organ system impairment rated with a single Cumulative Illness Rating Scale-Geriatric score (CIRS-G) of 4 or a total CIRS-G score of \> 17.
* History of or ongoing confirmed Progressive Multifocal Leukoencephalopathy.
* Known active significant infection.
* History of stroke or intracranial haemorrhage within 6 months before the first dose of study drug.
* History of bleeding diathesis (eg, haemophilia, von Willebrand disease).
* Major surgical procedure within 30 days of first dose of study intervention or anticipated major surgery during the study timeframe.
* Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists.
* Received a live virus vaccination within 28 days of the first dose of study drug.
Evaluation of the LungPoint Virtual Bronchoscopic Navigation (VBN) System

To evaluate the role of the LungPoint VBN System in the bronchoscopic access to a target location.

The evaluation will explore:

* Ability of the system to guide a user to one or more target site(s)
* Ease of use of the system (assessment of the user interface)
* Incremental value brought by the use of the system to the successful completion of a case.

Multi-center, prospective, single-arm study. The Study will take the form of a User Evaluation. The Evaluation will require the user to perform several standardized functions (e.g. peripheral lesion sampling, lymph node sampling). In addition, users will be asked about other potential techniques that fall within the intended use of the device.

The evaluation will be conducted in patients who are indicated for procedures that fall within the intended use of the device. Examples of such patients include:

* Patients who have been recommended for bronchoscopy for the purpose of obtaining a biopsy sample of a central or peripheral pulmonary lesion.
* Patients who have been recommended for bronchoscopy for the purpose of diagnosing mediastinal or hilar lymphadenopathy.
* Patients who have been recommended for bronchoscopy for the purpose of lung fiducial placement.

Eligibility Criteria:
Inclusion Criteria:

* Subject has provided Informed Consent
* Subject is scheduled for bronchoscopy for the purpose of diagnosing: a central or peripheral pulmonary nodule or mass, infiltrative disease, mediastinal or hilar lymphadenopathy, or placing fiducial markers.
* Subject has a CT scan that is consistent with high-resolution specifications

Exclusion Criteria:

* Patients less than 18 years of age.
* Any patient that the Investigator feels is not appropriate for this study for any reason.
A Study of Absorption, Metabolism, Excretion, and Absolute Bioavailability of Carbon-14-Labelled [14C] Selpercatinib (LY3527723) in Healthy Male Participants

The main purpose of this study is to compare the amount of selpercatinib that gets into the blood stream and how long it takes the body to get rid of it and also to assess the pharmacokinetics (PK), metabolism, and routes and extent of elimination of selpercatinib in healthy male participants. The study will last up to 59 days (Part 1) or 46 days (Part 2) including screening and 7-day safety follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kilograms per meter squared (kg/m²)
* Have normal blood pressure, pulse rate, electrocardiogram (ECG), and blood and urine laboratory test results that are acceptable for the study
* Participants will be surgically sterile for at least 90 days prior to Check in or, when sexually active with female partners of childbearing potential, will agree to use effective contraception methods or abstain from sexual intercourse from the time of first dose through 90 days after study drug administration

Exclusion Criteria:

* Participation in any other radiolabeled investigational study drug trial within 12 months prior to Check-in
* Exposure to significant radiation (eg, serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring) within 12 months prior to Check-in
* Use or intention to use any medications/products known strong inducers or inhibitors of Cytochrome P450 3A4 enzymes, including St. John's wort, within 30 days prior to Check-in, unless deemed acceptable by the Investigator (or designee)
Evaluation Ofe the Anxiolytic Effect of EMONO in Children During Dental Care (MOPEA)

The EquiMolar Oxygen and Nitrous Oxyde mix (EMONO) is listed by the ANSM (National Agency for the Safety of Medicines and Health Products) as drugs with enhanced surveillance. EMONO is a gas composed equally of oxygen and nitrous oxide, presented in bottle. The University Hospital of Nantes is currently conducting a general evaluation of the EMONO use in the hospital context. The department of odontology is part of this movement and wants to study the anxiolytic effect expected during dental care under MEOPA in children in the Dental Care Center. This analysis follows a previous study (MEOPAeDent) that subjectively took into account this anxiolysis.

The EquiMolar Oxygen and Nitrous Oxide Mix (EMONO) is listed by the ANSM (National Agency for the Safety of Medicines and Health Products) as drugs with enhanced surveillance. EMONO is a gas composed equally of oxygen and nitrous oxide, presented in bottle. It has had a marketing authorization in France since 2001. Until 2009, it was reserved for hospital use and emergency vehicles; and indicated in the analgesia of short-term painful acts or during medical assistance. urgency in adults and children, dental sedation in children and frail subjects, and obstetrics. The actual benefit was considered important by the Transparency Committee.

Since 2009, a modification of the MAH for EMONO-based specialties has authorized their release from the hospital reserve, which can now be issued for professional use in city and dental surgery. Given the risks associated with the use of EMONO, in particular its potential for abuse and dependence, the ANSM conditioned its availability outside health facilities to the implementation of a common national RMP. This measure was also accompanied by a national monitoring of pharmacovigilance and addictovigilance. The latter is under the responsibility of CEIP-A of Nantes.

The University Hospital of Nantes is currently conducting a general evaluation of the use of EMONO in the hospital context. The department of odontology is part of this movement and wants to study the anxiolytic effect expected during dental care under EMONO in children in the Dental Care Center. This analysis follows a previous study (MEOPAeDent) that subjectively took into account this anxiolysis.

The analysis of this study will allow us to improve the good use of MEOPA for dental care.

Eligibility Criteria:
Inclusion Criteria:

* Children from 3 to 15 years,
* Requiring dental treatment under EMONO including local anesthesia
* Not opposed, as well as parents, to participate in the study
* Having a sufficiently cooperative attitude to allow the installation of the monitoring equipment
* The use of EMONO for dental care must be a first time for the child

Exclusion Criteria:

* The excluded patients will be those whose number of care is too important, justifying a general anesthesia. Similarly, patients who do not require anesthesia for their care will be excluded.
The Effects of Omega-3 Fatty Acids on Peripheral Arterial Disease II

Investigators hypothesize that high-dose n-3 polyunsaturated fatty acids (PUFA) oral supplementation will improve systemic inflammation, vascular function, and symptomatic status of patients with PAD. Investigators will explore novel mechanistic pathways by which n-3 PUFA affect PAD, evaluating the role of specialized lipid mediators involved in the resolution of inflammation.

The OMEGA-PAD II trial will be a 1:1 randomized, double-blinded trial comparing oral supplementation of n-3 PUFA (4.4g/day) to placebo in claudicants (Rutherford stage 1-3) for 3 months. Eligible patients will be screened according to specified inclusion and exclusion criteria. All patients will be treated per our current practice as reflected in the American Heart Association Practice guidelines on PAD. Blood draws, vascular function testing and 6-minute walking tests will be performed at baseline and after 3 months. n-3 PUFA supplementation will be achieved with 4 capsules of Pro-Omega twice daily (Nordic Naturals, Watsonville, California, USA), corresponding to a total of 4.4g/day. Each ProOmega capsule contains 325mg of EPA and 225mg of DHA. The placebo group will take the same number of capsules containing inactive substance (soybean; Nordic Naturals), designed to be the same color and shape as the treatment capsules.

Eligibility Criteria:
Inclusion Criteria:

1. Intermittent claudication (Rutherford 1-3)
2. One of the following:

   1. Resting or exercise ankle-brachial index (ABI) \<0.9
   2. toe pressure \< 70 mm Hg
   3. documentation on imaging of greater than or equal to 50% stenosis in segments of aortoiliac arteries, femoral arteries, or tibial arteries
3. Age 50 and more

Exclusion Criteria:

1. Critical limb ischemia
2. Hypersensitivity/allergies to fish or seafood
3. Already on n-3 PUFA or equivalent
4. Significant renal, hepatic, and inflammatory disease
5. Concurrent severe infections
6. Acute illness (myocardial infarction, stroke, major surgery within 30 days)
7. Receiving immunosuppressive medications or steroids
8. Age \< 50