cyrilzakka/clinical-trials huggingface dataset:
Oxygenation of the Cerebrum and Cooling During Transcatheter Aortic Valve Implantation (TAVI) Procedures - Part II

The aim of this study is to assess the possible neuroprotective effects of cooling (targeted cooling of the brain to 33°C) during Transcatheter Aortic Valve Implantation (TAVI) procedures. From start of anesthesia, until final valve implantation, local cooling (by the RhinoChill device) will be applied to the brain. Effect of cooling on cerebral oxygenation, by cerebral oxygen saturation monitoring (NIRS ForeSight technology) during the TAVI procedure will be continuously assessed during native valve manipulation and during final valve deployment (=primary endpoint of he study). As secondary endpoints, neuropsychological testing performed before and after TAVI procedure will assess the effects of the use of cooling during the TAVI procedure. Neuron-specific enolase (NSE) and S100-beta will be analyzed during and up to 72hrs after TAVI to compare the cerebral ischemic damage between cooled and non-cooled patients. And finally, diffusion-weighted MRI of the brain will be performed 5 days before and 5-7 days after TAVI to compare the number and total amount of cerebral ischemic insults between cooled and non-cooled patients. The hypothesis behind this study is that by local cooling of the brain during manipulation of the calcified aorta and aortic valve, the brain might be protected from cerebral ischemic insults.


Eligibility Criteria:
Inclusion Criteria:

* pts scheduled for transcatheter aortic valve implantation

Exclusion Criteria:

* pts with pacemaker already implanted
* pts with recent stroke or Transient Ischemic Attacks (TIA) (6months)
* pts with extreme claustrophobia for MRI brain examination
Comparison Between Deep Sclerectomy and Traditional Trabeculotomy & Trabeculectomy in Congenital Glaucoma

The investigators hypothesize that deep sclerectomy in congenital glaucoma is a safer procedure and may yield better results than trabeculotomy trabeculectomy approach.

Non penetrating glaucoma surgery depends on filtration through trabeculo-descmeto window as well as supra-choroidal space less to sub-conjunctival rout. the nature of the operation keeps the globe intact without penetration that leads to less complications compared to penetrating trabeculectomy combined with trabeculotomy.

Eligibility Criteria:
Inclusion Criteria:

* Any case diagnosed as congenital glaucoma with enlarged corneal diameter more than 11 mm and intra-ocular pressure above 21 mmHg, including corneal edema or Habb's Stria with or without optic disc cupping.
* Any case diagnosed as primary or secondary congenital glaucoma to ocular or systemic abnormalities.
* Within the age of (0 - 12).

Exclusion Criteria:

* Cases of congenital glaucoma with previous intervention.
* Age above 12 Yrs.
* Cases with secondary glaucoma caused by surgical intervention, ocular co-morbidity, medications or trauma
the Efficacy and Safety of Etanercept （Yi Sai Pu) in Chinese Patients With Moderate-to-Severe Psoriasis

This is a prospective, open-label, one-arm study. The study aims to assess the efficacy and safety of Etanercept therapy which help guide the clinical practice in real-world settings.


Eligibility Criteria:
Inclusion Criteria:

1.18 to 75 years of age 2.Moderate to severe chronic psoriasis, BSA≥3% 3.Duration of psoriasis≥6 months 4.Patients must be candidate for systemic therapy or phototherapy 5.No contradiction to Etanercept 6.Informed consent must be obtained 7.For female, ß-hCG test is negative and contraception is accepted

Exclusion Criteria:

1. Diagnosis of pustular psoriasis, erythroderma psoriasis or drug-induced psoriasis
2. Having severe infections, including hepatitis, HIV and tuberculosis
3. No live vaccines 12 weeks before enrollment, through the study and 1 year after the last dose of Etanercept
4. Having significant allergies to biological agents
5. Having the previous experience of biologics
6. Having a history of malignancy
7. Having contradictions to Etanercept
8. Refusal of contraception
9. Having serious or unstable/uncontrolled illnesses
Oral Bevacizumab-800CW and Cetuximab-800CW Administration to Detect Early Esophageal Adenocarcinomas

Previous studies have confirmed the great potential of quantitative fluorescence molecular endoscopy (qFME) when looking at additional lesion detection initially missed by high-definition white light endoscopy (HD-WLE) for surveillance of Barrett's esophagus.

However, the investigators hypothesized, that additional lesions can potentially be identified by simultaneous use of two targeted tracers because of variable expression of vascular endothelial growth factor A (VEGFA) and epidermal growth factor receptor (EGFR )within oesophageal adenocarcinoma (EAC). Until now, solely intravenous and topical administration of the tracers has been investigated. However, optimization of tracer administration and shortened incubation is necessary for clinical translation and implementation of this new technique from Barrett's esophagus (BE) expert centers to regional non-expert centers. BE surveillance procedures normally takes up to 15 minutes at regional hospitals, of which most of the procedural time is needed to take biopsies according to the Seattle protocol. Introducing qFME into these hospitals would elongate the procedure time with at least 10 - 15 minutes. This would increase healthcare costs and put increased pressure on BE healthcare. Ideally, the gastroenterologist can immediately start with the qFME procedure without any incubation time while maintaining the best target-to-background ratios (TBR) possible. Oral administration by drinking the tracer prior to the procedure would eliminate incubation time and its consequences. Quantified qFME with oral tracer administration and targeted biopsies could potentially replace the time-consuming, high miss rate Seattle protocol, improve lesion detection and decrease global healthcare costs associated with BE.

Eligibility Criteria:
Inclusion Criteria:

* BE patients without dysplasia and with suspected/diagnosed low-grade dysplasia (LGD), high-grade dysplasia (HGD) or superficial EAC and planned diagnostic and/or therapeutic endoscopy
* Written informed consent is obtained

Exclusion Criteria:

* Patients under the age of eighteen.
* Submucosal and invasive EAC, also defined as EAC with tumor, node and metastasis (TNM)-classification other than T1.
* Previous radiation therapy for esophageal cancer
* Known immunoglobulin allergy
* Previous chemotherapy, immunotherapy or related surgery
* Prior bevacizumab or cetuximab treatment
* Medical or psychiatric conditions that compromise the patient's ability to give informed consent
* Pregnancy or breast feeding.
3DPCT Combined With CT Guided RISI in the Treatment of Thoracic Malignant Tumors

The main technical difficulties in radioactive iodine-125 seed implantation (RISI) lie in the complexity of operation and the control of operation quality. The current data shows that under the combined guidance of 3D-printing template and CT, the accuracy of RISI has been significantly improved, and the actual target dose could meet the design requirements of preoperative plan.

At present, 3D printing templates (3DPT) are divided into non-coplanar templates (3DPNCT) and coplanar templates (3DPCT). In clinical practice, due to the complex technical requirements, high production cost and long printing time of 3DPNCT, a considerable number of patients can also complete the treatment with 3DPCT. Moreover, compared with 3DPNCT, 3DPCT has the advantages of accurate needle path control, fast needle path adjustment, convenient for intraoperative real-time optimization, without waiting for printing time, easy for doctors to master, lower cost than 3DPNCT, and easy to carry out at the grass-roots level. Therefore, this study intends to explore 3DPCT technology to further clarify: (1) the accuracy of 3DPCT assisted CT guided RISI in the treatment of thoracic malignant tumors; (2) the short-term efficacy and toxicity of 3DPCT assisted CT guided RISI in the treatment of thoracic malignant tumors.


Eligibility Criteria:
Inclusion Criteria:

* Pathological diagnosis of malignant tumor of chest, lesion diameter less than 7 cm.
* There is no extensive systemic metastasis or although there is metastasis, the metastasis have been controlled by early treatment.
* No bleeding tendency, anticoagulant therapy and / or antiplatelet coagulation drugs should be stopped for at least 1 week before treatment.
* No serious or uncontrolled underlying diseases (such as severe or uncontrolled hypertension, diabetes, cardiovascular and cerebrovascular diseases and organ dysfunction) are found.
* There is a suitable puncture path, and the therapeutic dose is expected to be achieved.
* KPS \> 70, expected to tolerate puncture / seed implantation, and expected survival time greater than 3 months.

Exclusion Criteria:

* Severe impairment of lung function (such as FEV1 \< 40% predicted value, FVC \< 50% predicted value, DLCO \< 40% predicted value).
* High risk of skin invasion and ulceration at the puncture site before treatment.
* There is a large range of liquefaction and necrosis in the lesion, and the expected seed distribution would be poor.
* Pregnant women, lactating women and mentally ill patients.
* The patient with poor compliance and unable to complete the treatment.
* Other conditions of the researchers who think it is not suitable to participate in this clinical trial.
Feasibility of the AveCure Microwave Ablation Technology for the Bronchoscopic Treatment of Malignant Central Airway Obstructions

This research is being done to evaluate the feasibility of the AveCure Flexible Microwave destruction of tissue (Ablation) Probe for the treatment of malignant central airway obstruction using a thin, tube-like instrument with a light and a lens for viewing and removing tissue (bronchoscopic).

The name of the intervention being used in this research study is:

AveCure Flexible Microwave Ablation Probe (handheld, surgical device that delivers microwave energy via flexible probe tip)

This research study is a prospective, single-arm, cohort study to evaluate the feasibility of Microwave Ablation (MWA) Probe for the bronchoscopic treatment of malignant lesions causing central airway obstructions (COA). The AveCure prob will be placed in contact with the COA to treat with energy.

The U.S. Food and Drug Administration (FDA) has approved this intervention for use throughout the body, but it has not been approved for the specific indication of central airway obstruction.

Research study procedures include screening for eligibility, hospitalization for bronchoscopy and MWA, blood tests, survey questionnaires, Computerized Tomography (CT) scan imaging, and pulmonary function tests.

Participation in this research study is expected to last about 6 months.

It is expected that about 10 people will take part in this research study.

MedWaves, Inc is funding this research study by providing the ablation probe and generator.

Eligibility Criteria:
Inclusion Criteria:

* Patients age between 18 and 80 years of age and able to provide informed consent.
* Candidate for bronchoscopy under general anesthesia.
* Diagnosis of central airway obstruction (trachea, right main stem bronchus, left main stem bronchus), as evidenced by CT or CT/PET imaging confirmed or suspected to be due to malignant etiology, for which the bronchoscopist has deemed that endoscopic ablation/debridement is indicated (i.e. endobronchial tumors, mixed endobronchial/extrinsic compression lesions).

Exclusion Criteria:

* Patients who are unable to understand the informed consent, including potential risks and benefits of the procedure.
* Patients in whom bronchoscopy under general anesthesia is contraindicated.
* Any comorbidity that the investigator feels would interfere with the safety of the subject or the evaluation of study objectives
* Pacemaker, implantable cardioverter, or another electronic implantable device
* Patients with coagulopathy
* Patients in other therapeutic lung cancer studies
* COVID-19 positive patient at the time of the procedure.
* Patients who are pregnant
* Patients with purely extrinsic compression of the airway.
Early Versus Delayed Urinary Catheter Removal After Minimally Invasive Lumbar Spine Surgery

The study aims to compare between early versus delayed urinary catheter removal the impact on time to ambulation (in minutes) after minimally invasive lumbar spine surgery

Early ambulation enables rapid removal of drainage tubes and canisters and decreases length of hospitalization. Previous article showed that a 1-day shorter in hospitalization led to an approximately US$ 2000 reduction in total patient costs. Another study examining patients after total knee arthroplasty found that an early discharge group, a decrease in length of stay in 22h resulted in financial savings of approximately US$ 600 per case.

Another author found that early ambulation was associated with 19% lower 90-day readmission rate. Moreover, early ambulation contributed to 50.6% lower probability of developing at least one complication than regular ambulation.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years and older
* Minimally invasive one- or two-level lumbar fusion procedures

Exclusion Criteria:

* Patients that cannot give consent
* Patients with lower extremity amputation(s);
* Non-minimally invasive surgeries
* Patients with pre-existing bladder/kidney or urinary tract dysfunction
* Patients with spinal cord injuries
* Patients with known lower extremity weakness and impaired mobility.
Endothelin Receptor Antagonism in Proteinuric Nephropathy

The number of people with kidney problems is increasing rapidly, related in part to the increasing prevalence of diabetes. Patients with kidney problems tend to have protein leaking into the urine (proteinuria). Both proteinuria and the kidney disease itself are associated with an increased risk of heart disease. Reducing proteinuria is an important treatment goal in people with kidney problems. Endothelin is a chemical produced both by blood vessels and the kidney. Higher than normal levels of endothelin are thought to contribute to progression of kidney disease and proteinuria. By using drugs that block the effects of endothelin ('endothelin receptor antagonists') we can hopefully reduce both of these. The purpose of the study is to ascertain whether endothelin receptor antagonists improve kidney function and reduce proteinuria more so than other commonly used drugs.

Response to ETA Receptor Antagonism/Nifedipine/Placebo Prior to the study visit subjects will be asked to refrain from alcohol for 24 hours. Tea and coffee will not be permitted for at least 12 hours before each visit. Studies will be conducted in a quiet, temperature-controlled room.

On arrival at the Clinical Research Centre on the study day, a brief medical enquiry and examination will confirm the ongoing suitability of the subject for the study. An intravenous cannula will be inserted into the antecubital fossa of each arm. We have developed a basic protocol described fully in our previous studies that allows us to measure systemic haemodynamics by the well validated technique of bioimpedance and renal function by standard para-aminohippurate (PAH; renal blood flow) and inulin (glomerular filtration rate) clearance studies.

Urinary protein excretion will be measured by collecting urine over 30 minute time periods. To ascertain the contribution of renal haemodynamics to any change in protein excretion renal blood flow and glomerular filtration rate will be measured. In addition, blood and urine will also be assayed for sodium, creatinine and osmolality to allow calculation of fractional excretion of sodium and free water clearance.

Systemic haemodynamic monitoring will be performed at 15 minute intervals during drug/placebo administration and at 30 minute intervals outwith these periods.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age 18-70
* Body mass index \<35
* Blood pressure \<160/110 mmHg
* CKD stage 2-5 as per the K/DOQI classification
* Proteinuria in one of the following categories: 0.3-1.5, \>1.5-3.0, and \>3.0-6.0 g/24hrs
* Normal serum albumin

Exclusion Criteria:

* Subject is below the age of legal consent, or is mentally or legally incapacitated
* History of multiple and/or severe allergic reactions to drugs (including study drugs), or food
* The subject has donated blood (450 ml) within the last 4 weeks
* Past or present drug or alcohol abuse including intravenous drug abuse at any time
* Participation in another clinical trial within 1 month
* Considered to be at high risk of HIV or hepatitis B
* Pregnant
Diagnostic Study of Lateral Ligament Complex Injury of Ankle

Comparative Study on Accuracy of Different Diagnostic Methods of Lateral Collateral Ligament Injury of Ankle

Background: The lateral ligament complex of ankle joint consisting of the anterior talofibular ligament (ATFL), the calcaneofibular ligament (CFL), and the posterior talofibular ligament (PTFL), is often injured by an ankle sprain. Improper diagnosis and treatment of lateral ligament complex injury are not only prone to recurrent sprain, pain, swelling and other symptoms, but also can lead to chronic lateral ankle instability, and osteoarthritis, which could seriously affect the joint motor function.

Method and objective: This study is a prospective diagnostic test. By comparing the sensitivity and specificity of stress X-ray, B-ultrasound, Computed tomography (CT), and Magnetic resonance imaging (MRI), and analyzing the imaging manifestations and characteristics of different diagnostic methods of lateral chronic ankle instability, We aim to propose the criteria of the imaging diagnosis of lateral ankle ligament injury.

Eligibility Criteria:
Inclusion Criteria:

* Chronic lateral ankle ligament injury due to ankle sprain in patients over 16 years of age.

Exclusion Criteria:

* Acute and subacute injury of the lateral ligament complex of the ankle joint (less than 3 months), malalignment of ankle (more than 5 degrees), osteoarthritis (stage IV).
Umbilical Cord Mesenchymal Stem Cells Transplantation in the Treatment of Chronic Obstructive Pulmonary Disease

This trial is to investigate the safety and potential therapeutic efficacy of allogeneic administration of umbilical cord-derived MSCs (UC-MSCs) as a supplementary intervention in combination with standard COPD medication treatments in patients with moderate-to-severe COPD based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2019 and Vietnam Ministry of Health's guidelines

The aim of this trial is to investigate the safety and potential therapeutic efficacy of allogeneic administration of umbilical cord-derived MSCs (UC-MSCs) as a supplementary intervention in combination with standard COPD medication treatments in patients with moderate-to-severe COPD based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2019 and Vietnam Ministry of Health's guidelines. This matched case-control phase I/II trial is conducted at Vinmec Times City International Hospital, Hanoi, Vietnam between June 2020 and December 2021. In this study, 40 patients will be enrolled and assigned into two age-, gender- and COPD condition-matched groups, including a UC-MSC group and a control group. Both groups will receive standard COPD medication treatment based on the GOLD 2019 guidelines and the Vietnam Ministry of Health protocol. The UC-MSC group will receive two doses of thawed UC-MSC product with an intervention interval of 3 months. The primary outcome measures will include the incidence of prespecified administrationassociated adverse events (AEs) and serious adverse events (SAEs). The efficacy will be evaluated based on the absolute changes in the number of admissions, arterial blood gas analysis, lung function and lung fibrosis via CT scan and chest X-ray. The clinical evaluation will be conducted at baseline and 3, 6, and 12 months post

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with COPD with stage B, C, or D according to GOLD 2019.
* Age between 40-75 years old.
* Both genders.

Exclusion Criteria:

* Smoker or less than 6 months of smoking cessation time.
* Asthma and other pulmonary-related diseases and injuries (including lung tuberculosis, restrictive lung disease, idiopathic pulmonary fibrosis, or lung cancer).
* Acute and/or active infection.
* Cancer.
* Patients with complex cardiovascular diseases (including valvular heart disease, cardiomyopathy, arrhythmia, congenital heart disease, hypertrophy syndrome).
* Liver and kidney failure.
* Pregnancy.
* Patients with life expectancy less than 6 months due to concomitant illness.
* Under immunosuppressive treatment within 8 weeks of the first screening visit.
* Patient diagnosed diabetes with HbA1C\>7%
Impact of Sleep Disruption on the Menstrual Cycle

The purpose of this study is to investigate whether sleep disruption affects menstrual cycle timing

Menstrual cycle dynamics were studied after sleep disruption

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Regular menstrual cycles

Exclusion Criteria:

* No medications affecting the menstrual cycle or sleep
Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine Coadministered With Two Attenuated Vaccines

Eligible participants were randomly assigned (1:1:1), using block randomization stratified, to either 3 groups. Group 1 will be immunized inactivated SARS-CoV-2 vaccine and varicella vaccine in day 0 followed by measles-mumps-rubella vaccine(MMR) in day 28.

Group 2 will be immunized varicella vaccine in day 0 followed by SARS-CoV-2 vaccine and MMR in day 28.

Group 3 will be immunized inactivated SARS-CoV-2 vaccine in day 0 followed by MMR and varicella vaccine in day 28.

Vaccines were administered 28 days apart, with blood samples taken on day 0 and day 28 before vaccination, and on day 56. Local and systemic symptoms and serious adverse events following immunzation were collected.


Eligibility Criteria:
Inclusion Criteria:

* Aged 4 years old
* With legal guardian signing the informed consent
* Able to participate in all planned visits and comply with all research procedures (such as completing diary cards of adverse events and participating visits)
* With clear vaccination records including no SARS-CoV-2 vaccine history, with 1 varicella vaccine and 2 measles-containing vaccines history
* the last attenuated vaccine was administered ≥28 days ago, and other vaccines administered ≥14 days ago
* With an axillary temperature ≤37.5℃ at the time of vaccination

Exclusion Criteria:

First dose exclusion criteria:

* With SARS-CoV-2 infection in the last 3 months (any of the following conditions shall be met: positive nucleic acid test; positive antigen test; suspected SARS-CoV-2 infection symptoms of subject or close contacts)
* allergic to any substance of the vaccine or with a severe allergic reactions history of vaccines (such as acute allergic reactions, angioneurotic edema, breathing difficulties, etc.)
* Suffering uncontrolled epilepsy or progressive nerve system diseases, or with a history of Gribali syndrome
* With acute illness, severe or acute attack of chronic illness or fever
* With immunodeficiency or weakened immune system or being treated with immunosuppressant drugs (oral steroids)
* Received non specific immunoglobulin within 3 months
* Any situation that researchers thought that might influence the consequence of the clinical trial Second dose exclusion criteria：
* Occurrence of any serious adverse event that may be related to the previous dose of study vaccine
* Occurrence of systemic adverse reactions or allergic reactions with a severity level ≥ 3 recognized by researchers after vaccination
* Any new situations that fit the first dose exclusion criteria
* Any situation that researchers thought that might influence the consequence of the clinical trial