cyrilzakka/clinical-trials huggingface dataset:
Ultrafiltration Therapy Registry Using Aquadex (ULTRA-Peds)

The ULTRA-Peds registry will employ a multi-center, single-arm, open-label, observational design to capture baseline, procedural and follow-up data on pediatric patients that have been treated (i.e., retrospective data from treatment at the time of registry approval by the IRB) or are scheduled to be treated (i.e., prospective data for on-label treatment after registry approval by the IRB) with Aquadex therapy according to local standard of care practices and decisions. All prospective data will be from on-label Aquadex treatment of pediatric patients weighing 20 kilograms or more. No data from prospective off-label treatment (i.e., Aquadex treatment with other adjunctive or conjunctive therapies for pediatric patients who may weigh less than 20kg) will be included in the registry. An estimated 10 sites in the United States who have received training in extracorporeal therapy and the Aquadex™ system will enroll a minimum of 500 patients.

The ULTRA-PEDs registry is designed to capture data in the real-World clinical setting on the Aquadex™ system in local standard of care, with the aim of understanding it's performance and utilization. Enrollment is expected to take approximately 2.5 years from the time the first patient is enrolled to the time the final patient is discharged from the hospital.

ULTRA-PEDs will allow prospective and retrospective data collection for the following scenarios:

* All prospective data for on-label use only (i.e., Aquadex ultrafiltration therapy for pediatric patients weighing 20 kg or more, whose fluid overload is unresponsive to medical management, including diuretics).
* Retrospective patients at the time of registry approval by IRB regardless of on-label or off-label use.

  * Retrospective on-label use
  * Retrospective off-label use (i.e., Aquadex ultrafiltration with other adjunctive or conjunctive therapies for pediatric patients who may weigh less than 20kg)

Eligibility Criteria:
Inclusion Criteria:

I. For enrollment in prospective data collection:

1. Patient age is 21 years or younger
2. Patient weighs 20 kilograms or more.
3. Patient or legally authorized representative provides written authorization or patient is hospitalized and receiving treatment in a center with an Institutional Review Board that has allowed for waived consent based on the type of data being collected for the Registry.
4. Patient is to undergo Aquadex therapy for fluid overload (i.e., fluid removal) as local standard of care.

II. For enrollment in retrospective data collection:

1. Patient age is 21 years or younger.
2. Patient or legally authorized representative provides written authorization or patient is hospitalized and receiving treatment in a center with an Institutional Review Board that has allowed for waived consent based on the type of data being collected for the Registry.
3. Patient underwent Aquadex therapy for fluid overload (i.e., fluid removal) as local standard of care.

Exclusion Criteria:

1. Unable or unwilling to provide informed consent
2. Unable or unwilling to comply with study requirements
Color Doppler and Peripheral Venous Catheters

Objective: To evaluate color Doppler flow ultrasound compared to standard clinical techniques, to detect the correct position of peripheral intravenous catheters in adult surgical patients.

Methods: A prospective study is conducted in adult (\>18 years old) patients scheduled to undergo elective surgery. Peripheral intravenous catheter position is evaluated with standard clinical techniques (free flow of fluid from a hanging bag, easy saline injection, and aspiration of blood), and with color flow Doppler ultrasound proximal to the insertion site. Comparative test performance is carried out.

Confirmation of adequate peripheral intravenous catheter placement should be determined before using the parenteral route; however, there is no gold standard universally accepted for this purpose. Determination of the correct position of freshly inserted peripheral intravenous catheters and already established intravenous lines depends largely on subjective clinical signs such as visual evidence of swelling around the insertion site, low resistance to infusion and free back-flow of blood. Ultrasound-guided cannulation of peripheral veins has gained popularity in recent years and is standard of practice in some institutions. Primarily used in guiding central line placement, the applications of ultrasound for vascular access continue to expand in the perioperative setting, thanks to its easy use, non-invasiveness and safety profile. On the other hand, utilization of color Doppler technology with flow injection test has been shown to be a valuable tool for early recognition of malfunctioning intravenous catheters. The color Doppler flow technique is both safe and reliable, and aids in identification of correct intravascular position of venous catheters in children.

This study aims to test the hypothesis that the color Doppler flow technique is superior to standard clinical techniques (free flow from a hanging intravenous fluid bag, aspiration of venous blood with syringe, and non-obstructed hand injection of 2 mL of normal saline) to detect the correct position of peripheral intravenous catheters in adult surgical patients.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years undergoing elective surgery with an indwelling peripheral venous catheter.

Exclusion Criteria:

* Patients with open wounds in the vicinity of the intravenous line insertion site or scar tissue on the extremity, as well as those with dressings, bandages, or casts on the extremity precluding adequate use of ultrasound.
A Study of Safety, Tolerability, and Pk of rhMBL in Pediatric Hematology/Oncology Pts With Fever and Neutropenia

The goal of this clinical research study is to find the dose of EZN-2232 that can be given to MBL deficient pediatric cancer patients undergoing chemotherapy. The pharmacokinetics, pharmacodynamics, and safety of the study drug will also be studied.

MBL deficient patients will be randomized in a ratio of 1:1 to receive a single dose of either 0.5 mg/kg or 1.0 mg/kg of intravenous rhMBL. A total of 24 patients will be treated in each of the rhMBL arms, (12 in the 0.5 mg/kg and 12 in the 1.0 mg/kg. All patients are to receive anti-infectious prophylactic supportive therapy as per institutional standards

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

* Children ages 2 to 17 receiving chemotherapy for hematological/oncological diseases.
* Patients must have documented MBL levels \<300 ng/mL in serum as evaluated in the screening protocol.
* Fever defined as an oral temperature equivalent of \>100.4°F (38°C).
* Neutropenia defined as an absolute neutrophil count ≤1,000/mm3 with the anticipation that the counts will fall below 500/mm3.
* Receiving broad spectrum antibiotics for fever and neutropenia.
* Patients with age-adjusted normal serum creatinine OR a creatinine clearance \>60 mL/min/1.73m2.
* Informed consent of the patient, parent or legally authorized representative obtained prior to entry.
* Reliable and willing to make themselves available for the duration of the study and to abide by the study restrictions.

Exclusion Criteria: Patients meeting any of the following exclusion criteria will not be eligible for enrollment.

* Patients receiving the preparative regimen for a bone marrow or hematopoietic stem cell transplantation.
* Concurrent serious illness in the opinion of the principal investigator that could potentially interfere with protocol compliance.
* Patient is pregnant, breast feeding or planning a pregnancy during the course of the study.
* Sexually active male and female patients not using an acceptable barrier method of contraception or practicing abstinence throughout the study and for at least 30 days after receiving their last treatment unless the patient is surgically or medically sterile.
* Patients with moderate or severe liver disease, as defined by:

AST or ALT \>5 times upper limit of normal (ULN) OR Total bilirubin \>2.5 times ULN.

* Patients with poor venous access that would preclude intravenous drug delivery or multiple blood draws.
* Current participation in another clinical study with an investigational agent and/or use of an investigational drug (not including investigational use of an FDA approved drug) in the 30 days before scheduled administration of rhMBL.
* Known allergic reactions to MBL or other human plasma products.
* Patients on hemodialysis unable to tolerate the volume of IV fluid on non-dialysis days.
To Evaluate Efficacy and Long-term Safety of Ozanimod in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis

Japanese patients with moderate or severe active ulcerative colitis as a subject when ozanimod 0.46 mg or 0.92 mg is orally administered is evaluated about dose response, efficacy and safety with placebo as a control.

Following the up to 5-week Screening Period, eligible subjects will be randomized to enter the 12 weeks placebo-controlled Induction Period (IP). Subjects who are responders at Week 12 will continue on their assigned treatment in the 40-week Maintenance Period (MP). Non responders at Week 12 have the option to enter the Open-label Extension (OLE). Subjects who complete the MP will be given the option to participate in the OLE. Subjects that enter the MP and experience disease relapse will also have the option to enter the OLE. The OLE will continue until marketing launch (about 4 years of ozanimod for Ulcerative colitis (UC), or until the Sponsor discontinues the development program.

Eligibility Criteria:
Inclusion Criteria:

Main Inclusion Criteria for Induction and Maintenance Periods

1. Subject is a Japanese male or female subjects aged 18 to 75 years at the time of signing the informed consent form (ICF) at Screening.
2. Subject has had Ulcerative Colitis (UC) diagnosed at least 3 months prior to first investigational product administration. The diagnosis should be confirmed by clinical and endoscopic evidence and corroborated by a histopathology report.
3. Subject has evidence of UC extending ≥ 15 cm from the anal verge as determined by Baseline endoscopy (flexible sigmoidoscopy or colonoscopy).
4. Subject has active UC defined as Mayo score of 6 to 12 inclusive, with endoscopic subscore of ≥ 2, a rectal bleeding score of ≥ 1, and a stool frequency score ≥ 1.

Main Inclusion Criteria for Open-label Extension Period

Subjects must satisfy the following criteria to be enrolled in the study:

1. Must have completed the Week 12 Visit and is non-responder at Week 12
2. Who completes the IP and enters the MP, completes participation through the last study treatment visit at Week 52 with maintaining clinical response, OR experiences disease relapse during the MP

Exclusion Criteria:

Main Exclusion Criteria

1. Subject has severe extensive colitis
2. Subject has diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn's disease or microscopic colitis or radiation colitis or ischemic colitis.
3. Subject has positive stool examination for pathogens (ova and parasites, bacteria) or positive test for toxin producing Clostridium difficile (C. difficile) at Screening.4. Subject is pregnant or breastfeeding

5. Subject has clinically relevant cardiovascular conditions
Epidemiological Study to Evaluate Adherence to Treatment in Bipolar Disorder: Adherence Study

The purpose of this study is to estimate adherence to treatment in bipolar patients, to characterize patients based on adherence degree and to describe the variables linked to poor adherence to treatment in real-life practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with bipolar disorder I or II DSM-IV
* Patients treated with at least one oral antipsychotic
* Subjects able to read and write

Exclusion Criteria:

* Patients participating in clinical trials
Safety and Tolerability Study of Ingenol Mebutate Compared to 5-FU to Treat Facial Actinic Keratosis

Background: 5% 5-fluorouracil cream (5-FU) is a well-established treatment for actinic keratosis (AK) and ingenol mebutate gel (IMB) is a new topical field therapy.

Objective: To compare tolerability and safety of IMB with 5-FU for the treatment of facial AKs.

Methods: Open-label, prospective, randomized, controlled clinical trial with 100 patients with AKs within 25-cm2 contiguous field on the face. IMB was applied daily for three consecutive days. 5-FU was applied twice a day for four weeks. Treatment effect was evaluated at baseline and on days 2, 3, 4, 8, 15, 22, 29, 36 and 43, considering ITT populations.


Eligibility Criteria:
Inclusion Criteria:

* age of at least 18 years
* the presence of four to eight clinically typical, visible, and discrete AKs within 25-cm2 contiguous field on the face (cheek or forehead region)
* Women with childbearing potential had to be using effective birth control and have a confirmed negative urine pregnancy test prior to trial treatment.

Exclusion Criteria:

* target treatment area was within 5 cm of an incompletely healed wound or within 10 cm of a suspected basal-cell or squamous-cell carcinoma
* if they have received previous treatment with ingenol mebutate gel on the face or scalp (previous treatment on trunk or extremities was acceptable)
* the selected treatment area had hyperkeratotic lesions or cutaneous horns and recalcitrant disease (lesions that had not responded to cryotherapy on two previous occasions)
* history or evidence of skin conditions that would interfere with the evaluation of the trial medication (e.g., eczema, unstable psoriasis, xeroderma pigmentosum)
* anticipated need for hospitalization or outpatient surgery during the first 15 days after the first trial medication application
* known sensitivity or allergy to any of the ingredients of ingenol mebutate gel or 5-FU
* presence of sunburn within of the target treatment area; current enrolment or participation in any other interventional clinical trial within 30 days of entry into this trial
* women breastfeeding
* recent use of medications or other treatments that could interfere with evaluation of the target area, such as topical medications (e.g. steroids, keratolytics, immunomodulators), artificial tanners, immunomodulators, cytotoxic drugs or interferon /interferon inducers, phototherapy, systemic retinoids, biologic/monoclonal antibody drugs, or other therapies for AKs within eight weeks prior to the first visit of the trial.
Delineation of Target Volume of Stereotactic Radiotherapy for Spinal Tumors

The purpose of this study was to compare efficacy and side effects of two target delineation methods for stereotactic radiotherapy of metastatic spinal tumors.

The purpose of this study was to compare efficacy and side effects of two target delineation methods for stereotactic radiotherapy of metastatic spinal tumors. This is a bidirectional cohort study planned to enroll approximately 500 patients with metastatic spinal tumors. Patients are divided into two groups according to the target delineation method. Group 1：The target bolume only includes local tumor. Group 2：The target bolume includes local tumor and adjacent vertebral area.

Eligibility Criteria:
Inclusion Criteria:

* Patients with spinal metastases or primary tumors receiving stereotactic radiotherapy;
* Patients with sufficent pre-treatment imaging data
* Patients who can cooperate with imaging review and follow-up after radiotherapy.

Exclusion Criteria:

* Patients with an expected survival of less than 3 months;
* Patients with second-course radiotherapy;
* Patients with physical conditions that cannot tolerate stereotactic radiotherapy;
* Patients with extensive spinal metastasis and no local therapeutic value
Safety and Efficacy Evaluation of Orbital Atherectomy System in de Novo Calcified Lesions

This is a French, prospective, single-arm, multi-center registry to confirm the safety and efficacy of the Diamondback 360 TM Orbital Atherectomy System in the preparation of de novo calcified coronary lesions before implantation of a coronary endoprothesis in adult subjects. The primary safety endpoint is 30-day MACE and the efficacy endpoint is procedural success.

Treatment of calcified lesions, caused in 6 to 20% of patients, remains a challenge.

Presence of coronary calcifications complicates stent placement resulting in up to 50% malapposition or under-expansion of the stent and is associated with a higher frequency of major adverse cardiac events (MACE).

In order to reduce these risks, preparation of these lesions before the implantation of a coronary stent is essential. The arrival on the European market of a new Orbital atherectomy system leads to consider its use in the preparation of such lesions.

The orbital atherectomy system uses a diamond-coated eccentric crown that abrades calcified plaque and develops pulsatile forces on the wall. It reduces calcified plaque and modifies plaque with fractures, facilitating stent placement and allowing for optimal stent expansion.

ORBIT I and ORBIT II clinical trials were conducted in the United States to evaluate the safety of using the Orbital Atherectomy System in de novo calcified coronary lesions in adults. These 2 trials demonstrated that orbital atherectomy not only facilitated stenting, but also improved clinical outcomes compared to historical outcomes.

The recent obtaining of CE marking allows the use of this very promising medical device in France.

Eligibility Criteria:
Inclusion Criteria:

* Subjects ≥ 18 years
* Patients with a clinical indication for coronary angioplasty and presenting a de novo calcified lesion
* The target vessel reference diameter must be \>= 2.5mm and \<= 4.0 mm.
* Lesion length \<= 40 mm
* The target vessel must be a coronary artery with a stenosis of \>70%
* Patients able to understand and provide informed consent
* Patients with Social Security coverage

Exclusion Criteria:

* Patients with an LVEF \< 25%.
* Patient with hypersensitivity to egg, soy or peanut proteins or to one of the active substances or one of the excipients of ViperSlide lubricant.
* Pregnant or breastfeeding woman
* Unwilling or unable to sign the Informed Consent
* Patients under judicial protection, tutorship or curatorship
* Angiographic criteria: Intra-stent stenosis, Presence of a chronic total occlusion (CTO), Bypass lesion, Target vessel excessively tortuous, Presence of a thrombus, Presence of a single permeable vessel
A Validation of the Functional Low-Vision Observer Rated Assessment (FLORA-20) for Profoundly Blind Individuals

This study aims to validate an observer-rated assessment titled "Functional Low-Vision Observer Rated Assessment (FLORA-20)", which comprises 20 functional vision tasks commonly performed in or around a blind individual's home environment. This study shall be carried out with individuals who have an implanted visual prosthesis device. There are no new implantations or changes to the original implant or external wearables being studied or tested. Additionally, data from the study shall not be used alter standard of care or the user's treatment options.


Eligibility Criteria:
Inclusion Criteria:

* Subjects implanted with the Argus II or Orion device
* Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
* Subject is able to follow instructions and comply with FLORA-20 scheduling and completion of tasks
* Subject is willing to be filmed while performing the FLORA-20 tasks during the study

Exclusion Criteria:

* Subject is unsuitable for study participation as determined by Investigator's clinical judgment (with Sponsor's final input).
Evaluation of Safety and Effectiveness of the BioMimics 3D Stent System

To demonstrate that the BioMimics 3D Stent System meets the performance goals defined by VIVA Physicians, Inc. for the safety and effectiveness of Nitinol stents used in the treatment of symptomatic disease of the femoropopliteal artery. It is a prospective, single-arm, multicenter clinical trial.

The BioMimics 3D stent is intended to improve luminal diameter in the treatment of symptomatic de-novo, obstructive or occlusive lesions in native femoropopliteal arteries with reference vessel diameters ranging from 4.0 - 6.0 mm. Subjects with symptomatic atherosclerotic disease of the femoropopliteal artery who comply with all study eligibility criteria may be considered for enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic peripheral arterial disease (PAD) of the lower extremities requiring intervention to relieve de novo obstruction or occlusion of the native femoropopliteal artery.
* PAD classified as Rutherford clinical category 2, 3 or 4.
* Resting ankle-brachial index (ABI) of ≤0.90 (or ≤0.75 after exercise of the target limb) or angiographic or DUS evidence of \>/= 60%.
* Single or multiple stenotic or occlusive lesions within the native femoropopliteal artery ("target lesions") that can be crossed with a guidewire and fully dilated.
* Single or multiple target lesions must be covered by a single stent or two overlapping stents.
* Target lesion(s) eligible for treatment at least 1 cm distal to the origin of the deep femoral artery and at least 3 cm above the bottom of the femur.
* Target lesion(s) reference vessel diameter is between 4.0 mm and 6.0 mm.
* Single or multiple target lesions measure ≥40 mm to ≤140 mm in overall length, with ≥60% diameter stenosis by operator's visual estimate.
* Patent popliteal artery (no stenosis ≥50%) distal to the treated segment.
* At least one patent infrapopliteal vessel (\<50% stenosis) with run-off to the ankle.

Exclusion Criteria:

* Iliac stent in target limb that has required re-intervention within 12 months prior to index.
* Target vessel that has been treated with bypass surgery.
* PAD classified as Rutherford clinical category 0, 1, 5 or 6.
* Known coagulopathy or has bleeding diatheses, thrombocytopenia with platelet count less than 100,000/microliter or INR \>1.8.
* Stroke diagnosis within 3 months prior to enrollment.
* History of unstable angina or myocardial infarction within 60 days prior to enrollment.
* Thrombolysis within 72 hours prior to the index procedure.
* Acute or chronic renal disease (e.g., as measured by a serum creatinine of \>2.5 mg/dL or \>220 umol/L), or on peritoneal or hemodialysis.
* Significant disease or obstruction (≥50%) of the inflow tract that has not been successfully treated at the time of the index procedure (success measured as ≤30% residual stenosis, without complication).
* No patent (≥50% stenosis) outflow vessel providing run-off to the ankle.
* Target lesion(s) requires percutaneous interventional treatment, beyond standard balloon angioplasty alone, prior to placement of the study stent.