cyrilzakka/clinical-trials huggingface dataset:
Deuteporfin Tolerance and Pharmacokinetics in Healthy Volunteers

Deuteporfin, a novel photodynamic drug developed in China, displays good photodynamic antitumor activity. The purpose of the present study is to investigate the safety and pharmacokinetics of intravenous deuteporfin in healthy Chinese volunteers following single-dose administration.


Eligibility Criteria:
Inclusion Criteria:

* Chinese healthy male and/or female subjects
* 18 to 45 years old with Body mass index (BMI) within the range of 19 to 24 kg/m2
* weigh at least 45 kg for female subjects or 50 kg for male subjects
* In good health as confirmed by past medical history, physical examination, electrocardiogram, laboratory tests and urinalysis on the screening and baseline evaluation
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria:

* Significant illness or major surgery within four weeks prior to dosing
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies and photoallergy)
* Use of any drugs which might interfere with drug absorption, distribution, metabolism, excretion or cause photoallergy within 30 days prior to dosing, or any drugs within 14 days prior to dosing
* Participation in any clinical investigation within 30 days prior to dosing
* Smokers, alcoholics, drug abusers
* Immunodeficiency diseases, including a positive HIV test result, Positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result
* pregnancy or lactation for female subjects
Use of Sentinel Lymph Node Biopsy in Patients with Early-Stage, Palpable Node-Positive HR+/HER2- Breast Cancer Having Upfront Surgery and Adjuvant Radiation

The purpose of this study is to find out how often the researchers can avoid an ALND in patients with early-stage, node-positive HR+/HER2- breast cancer who are having upfront surgery. The study researchers think that, if AUS before surgery can help identify people who may have up to 3 affected lymph nodes, it will be possible to perform the less radical standard SLNB during surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥18 years with biopsy-proven invasive breast cancer
* Patients with cTx, cT1, or cT2 tumors with palpable ipsilateral mobile adenopathy of level I/II axillary nodes with biopsy-proven (either by pre-operative biopsy or intraoperative frozen section) nodal metastasis (cN1) who are undergoing upfront surgery
* Patients with tumors of the HR+/HER2- subtype, defined as:

  1. HR+: Positive for estrogen receptor and/or progesterone receptor staining, indicated by ≥1% immunoreactive tumor nuclei
  2. HER2-: Immunohistochemistry assay demonstrating no or faint staining in ≤10% of tumor cells (IHC 0 or 1+) or negative by dual probe in situ hybridization assay

Exclusion Criteria:

* Patients with prior ipsilateral breast cancer
* Patients who are pregnant
* Patients with stage IV disease at presentation
* Patients with advanced regional disease (cN2/cN3)
FilmArray Pneumonia Panel for Antimicrobial Treatment of HAP/VAP in Intensive Care Units

Microbiologic diagnosis of pneumonia is often limited by a long turnaround time of cultures. This randomized trial aims to evaluate the impact of BioFire FilmArray Pneumonia panel on (1) the proportion of appropriate/optimal early antibiotic regimen and (2) the time to the administration of appropriate antibiotics in patients treated for hospital-acquired or ventilator-associated pneumonia (HAP/VAP) in ICU.

The study subjects are adults treated for HAP/VAP in ICU, who should be enrolled within 24 hrs since the first administration of antibiotics. Informed consent are obtained from the subjects or their legal proxies. Due to the unique characteristics of ICU and the current COVID-19 pandemic, consent may be obtained via telephone when given by legal proxies; written consent should be obtained later. The subjects who meet the inclusion criteria are randomized into either intervention and control arms in 1:1 ratio. Respiratory specimens from the subjects in the intervention arm are tested with the FilmArray Pneumonia panel. Other routine microbiologic tests are performed for the subjects in both arms. The results are reported via electronic medical record, and the treating physicians may adjust antibiotic regimen with the assistance from the guidance formulated by the study investigators. No intervention is made on the antimicrobial treatment in the control arm. Primary outcomes are (1) the proportion of appropriate/optimal early antibiotic regimen and (2) the time to the administration of appropriate antibiotics.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 19 years or older
2. Diagnosed with hospital-acquired or ventilator-associated pneumonia and being treated in an intensive care unit
3. Patient or his/her legal proxy agrees to participate and is able to provide informed consent

Exclusion Criteria:

1. Has been treated with antibiotic for HAP/VAP for 24 hr or longer
2. Requires antibiotic treatment for indications other than HAP/VAP
3. Bacteria has been isolated from respiratory specimens within 7 days prior to screening
4. Immunocompromised host whose major differential diagnosis includes Pneumocystis jirovecii or cytomegalovirus pneumonia
5. Expected to die within 2 days since screening due to underlying disease
6. Has an advance directive against mechanical ventilation or cardiopulmonary resuscitation
7. Does not want to participate or unable to provide consent
8. Determined to be unfit by the study investigator
Effect of High Frequency/Low Intensity Transcranial Magnetic Stimulation in Cognitive Traits of an Elderly Population of Subjects With Mild Cognitive Impairment and Mild Dementia.

There are no pharmacological interventions that delay or prevent the transition of mild cognitive impairment to dementia. Several studies have shown that transcranial magnetic stimulation (TMS) could be useful in increasing cognitive traits in dementia.

As TMS is performed in a clinical setting, transportation, mobility and high costs of treatment, limit the number of TMS sessions dementia patients can receive. Most of the trials do not apply more than 20 TMS sessions

Here, a randomized, sham controlled, paralallel group, clinical trial will be performed in order to asess the efficacy at improving cognitive traits of a novel TMS device that uses high frequency and low intensity pulses. As the device is portable and can be used from home without clinical supervision, the stimulation will be applied two times per day for a period of 6 months.


Eligibility Criteria:
IInclusion Criteria:

( - ) CDR less or equal to 1 ( - ) Mild cognitive impairment by Petersen criteria ( - ) Conserved or corrected sight ( - ) Enrolled at INCMNSZ for medical care ( - ) Be able to read and write ( - ) Willing and able to provide written informed consent

Exclusion Criteria:

( - ) Other neurodegenerative disorder different than mild cognitive impairment or mild dementia ( - ) Metabolic disease without medical care ( - ) Epilepsy ( - ) Deep brain stimulator ( - ) Metalic prosthethics in the skulls ( - ) Major depressive disorder ( - ) Previous utilization of other neuromodulation technique ( - ) Signs or symptoms of increased intracraneal pressure
Semibranch Registry - Retrospective

The goal of this registry is to evaluate the semibranch in branched endovascular arotic repair, which is a new tool in endovascular branched aortic repair.

The main question it aims to answer are:

* Patency of the semibranch
* Feasibility of the technique regarding cannulation and stentgrafting

Eligibility Criteria:
* Patient has been treated with the semibranch stentgraft
* Patient is over 18 years old
The Effect of Nurse Training on the Improvement of Subcutaneous Heparin Applications

One of the most important duties and responsibilities of nurses is drug administration. During drug administration, the nurse uses appropriate administration techniques and ensures patient safety by knowing the drugs and their side effects. This study aimed to examine the effect of nurse training on the improvement of subcutaneous heparin applications. In this study, it was planned to train nurses by using two different training methods. These methods are online and face-to-face training.

In both methods, it was planned to evaluate the subcutaneous drug administration knowledge and skill of nurses before and after the training.

Drug administration is a common nursing clinical intervention. The nurse ensures patient safety by using compatible administration techniques and being aware of the side effects of medications. Pharmacological agents such as heparins, vaccines, insulin, hormone drugs, etc., are generally inappropriate with oral, intravenous or intamuscular intake. Thereupon, they have to be administered by means of subcutaneous (SC) injection. Subcutaneous medications are injected into the tissue layer between the skin and the muscle that is called subcutaneous tissue where does not have a rich blood supply. Suitable areas for subcutaneous injction application are the lateral aspect of the upper arms, posterior aspect of the upper arms, anterior surface of the thigh, unders the scapulas and abdomen in the umbilical region. For the reason that abdominal region has an excess subcutaneous fat tissue, enough space for repeated injections and less muscle activity, it is highly preferred for subcutaneous injections. The angle of entry of the needle into the tissue depends on the needle length and the thickness of the subcutaneous tissue mass. A 90-degree angle is used if the subcutaneous tissue thicknes is about 5 cm. However, when it is 2.5 cm the angle of a 45-degree angle is recommended. To check whether the needle tip is in the vein or not during the application causes the needle movement in the tissue that then results in vascular damage, bleeding, ecchymosis and hematoma formation. Airlock technique in subcutaneous inections is recommended as it ensures that the entire drug is delivered to the tissue as well as preventing the escape of the drug.

Eligibility Criteria:
Inclusion Criteria:

* volunteering to participate in the study

Exclusion Criteria:

* not have administered subcutaneous heparin in the clinical practice
Effect of the Consumption of Burgers Prepared With Wine Grape Pomace Flour, on Components of the Metabolic Syndrome

Wine grape pomace flour (WGPF) is a fruit byproduct high in fiber and antioxidants. The effect of WGPF consumption was tested on blood biochemical parameters including oxidative stress biomarkers. In a 3-month intervention study, 27 male volunteers, each with some components of metabolic syndrome, consumed a beef burger supplemented with 7% WGPF containing 3.5% of fiber and 1.2 mg GE/g of polyphenols (WGPF-burger), daily during the first month. The volunteers consumed no burgers in the second month, and one control burger daily in the third month. At baseline and after these periods, there were evaluated metabolic syndrome components, plasma antioxidant status \[2,2-diphenyl-1-picrylhydrazyl radical scavenging capacity (DPPH),uric acid, vitamin E, vitamin C\], and oxidative damage markers \[advanced oxidation protein products (AOPP), oxidized low-density lipoproteins (oxLDL), malondialdehyde (MDA)\].

The intervention was carried out at workplaces in Santiago, Chile. Workers were informed about the study and invited to participate. Initially, 34 male workers meeting all criteria agreed to partake, however 27 workers completed the study. Seven volunteers quit the study because three disliked the blood sampling procedure, two were sent to work abroad, one left the workplace, and one presented gastrointestinal symptoms associated with WGPF-burger consumption.

The volunteers entered a longitudinal trial consisting of two treatment periods of 4 weeks, separated by a third four-week wash-out period. For the first 4 weeks, they consumed one WGPF-burger daily, then they were washed-out and finally they consumed one control-burger daily during 4 weeks. They were asked to maintain their regular eating habits and lifestyle during the study, except for the daily intake of burgers during the treatment periods. The burgers were eaten in replacement of red or processed meat consumption, or in addition to their regular meal when it did not contain meat products. During the washout period, all subjects consumed their usual diet. Burger intake was supervised every day at lunch at the canteens of the workplaces. On weekends, participants were asked to consume burgers at home with their regular meals. In addition, compliance with burger consumption was carefully monitored by frequent calls from the dietitian.

Blood samples were obtained at weeks 0, 4, 8, and 12 for analysis. Participants had clinical, nutritional, and anthropometric evaluations at the beginning and the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria were having at least one of the five components of metabolic syndrome and a BMI between 25.0 and 39.9 kg/m2

Exclusion Criteria:

* Exclusion criteria were use of drug therapy for diabetes mellitus, hypertension, or dyslipidemia and intake of pharmacological treatment with drugs that modify plasma antioxidant capacity or inflammation.
The SIBERIA Trial (Acculink™ Versus CGuard™)

That the study will be carried out as it has the protocol instructions, respecting the applicable regulations for clinical investigations with medical devices and following the internationally accepted ethical standards

Independent Randomized Trial in Carotid Artery Revascularization Comparing the Stent (Acculink™) Versus the Mesh Covered Stent (CGuard™) was performed.

Ischemic lesions of brain after CAS were determined by MRI before and after treatment (2-3 days, 1 month).

Eligibility Criteria:
Inclusion Criteria

1. Consecutive patients 45-80 years old accepted for CAS following neurological consultation and qualification for the procedure according to center's routine practice.
2. More than 6-month life expectancy
3. Suitable clinical conditions for performing DW-MRI
4. Written Informed consent approved by the Ethics Committee
5. Subject agrees to all required follow-up procedures and visits

Exclusion Criteria:

1. Currently enrolled in another investigational device or drug study that has not completed the study or that clinically interferes with the current study endpoints
2. Recent surgical procedure within 30-days before or planned surgery within 30-days after the stenting procedure
3. Hepatic active disease (bilirubin\> 35 mmol / l) or renal insufficiency (serum creatinine \> 2.5 mg/dL or glomerular filtration rate \<60 ml / min)
4. Recent evolving acute stroke within 30-days of study evaluation
5. Myocardial infarction within 72 hours prior to carotid stenting procedure (CPK-MB \> 3 times normal)
6. Female patients of childbearing potential or known to be pregnant
7. Any known factor for potential stroke other than carotid stenosis, such as atrial fibrillation or atrial flutter (paroxysmal, permanent or persistent) or thrombophilia
8. Patient on VKA or new oral anticoagulants
The Effect of Intracameral Cefuroxime on Post-op Fibrin in Pediatric Cataract Surgery

The study investigates whether placing an antibiotic inside the eye at the end of cataract surgery in children will reduce the amount of fibrin formation (fibrin formation can block the pupil and reduce vision). We hypothesize that the fibrin is caused by a low-level infection and could be prevented by the antibiotic.

The study investigates whether using an antibiotic (cefuroxime) in the anterior chamber of the eye at the end of surgery for cataract in children will reduce the amount of fibrin formation.

Eligibility Criteria:
Inclusion Criteria:

* bilateral congenital or developmental pediatric cataract

Exclusion Criteria:

* traumatic cataract
MCJR Joint Replacement Clinical Outcomes Database

The purpose of this research study is to develop a database of information regarding the diagnosis, treatment, and outcome of participants who have had a joint replacement. The more information gathered, the better the investigators will be able to treat future patients who need a joint replacement. For example the investigators learn what works well to help design implants and treatment protocols for the future. The investigators publish manuscripts and present research findings around the world to help other investigators and clinicians learn what is discovered. Furthermore, implant manufacturers may be able to use this information in the database to evaluate the success rates of specific joint replacement products.

As part of our growing clinical tracking EMR system the investigators plan to collect preoperative and postoperative Patient Reported Outcome Measures (PROMS) on all patients with degenerative hip and knee disease. The investigators will collect PROMS along with implant device specific revision rates. This will be used for implant surveillance, clinical outcome tracking, return to work outcome metrics and failure modes and rates of various hip and knee implants. Information generated during regular hospital and clinic visits will be entered into the database. For example, x-ray findings done before surgery will be entered into the database. Surgery information will be entered into the database. The investigators will also enter demographic information into the database such as name, email, birthdate, gender, height, and weight. Medical co-morbidities such as diabetes, high blood pressure, and prior surgeries will also be entered.

The investigators will collect this information before surgery, during the operation, and at annual follow-up visits. The investigators will also contact patients via email with short outcome score surveys (known as Patient Reported Outcome Measures or PROM's). This will save many hours of return visits if scores indicate the joint replacements are doing well. Also this will trigger additional follow-up measures if PROMS scores drop off.

Eligibility Criteria:
Inclusion Criteria: Clinical diagnosis of degenerative joint disease requiring treatment with a joint replacement

Exclusion Criteria: Clinical diagnosis of degenerative joint disease not requiring treatment with a joint replacement
Breathwork App for Cancer Survivors

Cancer survivorship is associated with many long-term chronic health issues that arise as a result of cancer treatment protocols. Non-pharmacological lifestyle and mind-body interventions have been shown to be effective and critical components of a total-health strategy for cancer survivors. PranaScience Institute seeks to develop and test a novel group video app for home-based delivery of a Yogic Breathing intervention that reduces symptoms of cancer treatment survival and supports total-health.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older, willing to provide informed consent.
2. Diagnosis of Stage 0-III breast cancer.
3. Completion of radiation therapy within the last 6 months.
4. ECOG performance status of 0-3 during cancer treatment.
5. Orally expressed visual and auditory acuity adequate for filling out all study forms and participating in telephone interviews and internet-based group video applications.
6. Access to telephone and internet-connected computer or mobile phone.

Exclusion Criteria:

1. Subject is unwilling or unable to comply with any of the study procedures.
2. Orally expressed dependence on alcohol or drugs.
Bariatric Surgery and Pharmacokinetics of Dexamphetamine

Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on dexamphetamine are investigated.


Eligibility Criteria:
Inclusion Criteria:

* Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
* Being a Norwegian citizen

Exclusion Criteria:

* Having previously undergone resections in the GI-tract
SAVR: IMPACT of Pre-existing Comorbidities on Patient Outcomes and Prosthetic Valve Performance in a Real-world Setting.

The IMPACT Registry represents a non-interventional, prospective, open-label, multicenter, international registry with a follow-up of 5 years that includes data of patients undergoing aortic valve replacement with the Edwards INSPIRIS RESILIA Aortic Valve™. The IMPACT Registry will be performed in up to 25 participating sites across Germany, Austria and Switzerland. A minimum number of 500 patients (20 patients per center) will be enrolled. Patients will undergo follow-up visits at baseline, surgery, pre-discharge, year 1, year 3 and year 5.

The INSPIRIS RESILIA Aortic Valve™ is a stented tri-leaflet valve comprised of bovine pericardial tissue. The tissue is created by treating bovine pericardial tissue with Edwards Integrity Preservation. It incorporates a stable capping anticalcification process, which blocks residual aldehyde groups known to bind with calcium. Tissue preservation with glycerol allows the valve to be stored without a traditional liquid-based solution, such as glutaraldehyde. Therefore, valve is stored under dry packaging conditions and consequently does not require rinsing prior to implantation.

The novel tissue preservation technology significantly improves hemodynamic and anticalcification properties compared with the standard Perimount valve in an ovine model (Flameng et al., 2015). The RESILIA tissue has been studied in the COMMENCE trial: Two year data show that the NYHA class improved in 65.7% of patients, effective orifice area after implantation was 1.6 ± 0.5 cm2; mean gradient was 10.1 ± 4.3 mmHg; and paravalvular leak was none/trivial in 94.5% of patients (mild to moderate in 0.5%) (Puskas et al., 2017).

On the sizes 19 - 25 mm the INSPIRIS RESILIA Aortic Valve™ has been outfitted with the VFit technology, which incorporates two novel features designed for potential future valve-in-valve procedures: fluoroscopically visible size markers and an expandable cobalt chromium alloy band. No clinical data are available that evaluate the use of the INSPIRIS RESILIA Aortic Valve™ in patients to date.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is at least 18 years old
2. Patient has an aortic valve vitium and requires an aortic valve replacement with the Edwards INSPIRIS RESILIA Aortic Valve™
3. Patient is scheduled to attend yearly follow-up visits at the registry center up to 5 years
4. Patient provides written informed consent prior to the procedure and in case of emergency after the procedure.

Exclusion Criteria:

1. Disability and / or other circumstances under which the patient is not capable to understand the nature, significance and scope of the clinical trial
2. Active endocarditis/myocarditis or endocarditis/myocarditis within 3 months prior to the scheduled aortic valve replacement surgery
3. Patient has a life expectancy ≤ 12 months for any reason
4. Valve implantation is not possible in accordance with the device IFU
5. Pregnancy