cyrilzakka/clinical-trials huggingface dataset:
Efficacy of ADW S-100 Ionized Water Nasal Spray in Decreasing SARS-Cov-2 Viral Load.

A nasal spray based on Advanced Water S-100 ionized water would clean the nasal cavity, reduce the viscosity of the mucus and facilitate its elimination and the decongestion of the nose and the prevention of the seizure of the SARS-COV-2 to the epithelial cells of the nasal cavity In fact, a nasal spray based on Advanced Water S-100 ionized water would modify the electrostatic environment of all interactions ensuring this seizure. The negative ions (OH-) contained in Advanced Water S-100 compete with the negative ions of the heparan sulfate, which will destabilize this essential bond for the virus to enter the host cell. In addition, positively charged basic amino acids, in the presence of the basic pH of ADW S-100, will be neutralized by OH- ions which will prevent the formation of salt and hydrogen bridges mediating the formation of the protein S/ACE2 complex. The destabilization of all bonds governing the protein S/ACE2 association process will prevent the virus from entering cells and replicating.

The aim of this study is to evaluate whether the use of ADW S-100 ionized water nasal spray reduces the salivary and nasopharyngeal viral load during an 8-day follow-up of persons recently infected with SARS-Cov-2, and thus potentially decreases the risk of contamination of the entourage.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women ≥ 18 years old
2. Informed consent
3. Beneficiaries of a social security plan
4. Vaccinated or unvaccinated against SARS-COV-2:

   * Vaccinated individuals have had a 3rd dose for at least one month, or have been infected with SARS-Cov-2 and have had 2 doses of vaccine for at least one month
   * Unvaccinated persons are naïve to previous SARS Cov 2 infection
5. Positive nasopharyngeal RT-PCR test for selection with a Ct viral load ≤ 23
6. Have a phone and internet connection to access the entry application

Exclusion Criteria:

1. The participant is related to any member of the study staff or has a close relationship or conflict of interest with the sponsor.
2. Known hypersensitivity or allergy to any component of the test product.
3. Contraindication to nasal spray
4. Insufficient vaccination: any incomplete vaccination schedule

   * either a 3rd dose within the last month
   * or SARS-Cov-2 infection with less than 2 vaccine doses or with 2 vaccine doses less than 1 month old.
5. Any condition, including COVID, that is likely to result in hospitalization during study participation.
6. Conditions that may result in hospitalization during study participation.
7. Known pregnancy or positive urine pregnancy test at D0 by the nurse, or current breastfeeding
8. Participation in an antiviral clinical trial or other trial using a medical device for disease prevention COVID 19
Impact of Glistenings in AcrySof Intraocular Lenses on Visual Quality

This study will assess the impact of IOL glistenings on visual quality and function in patients implanted with a single-piece AcrySof intraocular lens (IOL) that exhibits glistening formations. The primary objective is to determine if random light scattering (measured by C-Quant)correlates with severity of glistenings, other objective measures of visual function (visual acuity, low contrast visual acuity, low contrast visual acuity with glare), and subjective measures of patients' perceptions of their visual quality after cataract surgery (quality of life survey, reports of symptomology and satisfaction).


Eligibility Criteria:
Inclusion Criteria:

1. Presence of obvious glistenings by slit lamp exam
2. Best spectacle corrected visual acuity of 20/20 or better on the Snellen chart at most recent exam

Exclusion Criteria:

1. Any central corneal pathology that could have impact on vision other than mild guttata felt unlikely to have any impact on corneal clarity.
2. Any documented glaucoma of any kind.
3. Any macular pathology except minimal drusen without retinal pigment epithelial pathology felt to be consistent with normal vision.
4. Any diabetic retinopathy other than minimal background diabetic retinopathy felt unlikely to affect vision.
5. Any other cause of central visual acuity loss including optic nerve, occipital cortex dysfunction or amblyopia.
6. Diagnosis of dry eye syndrome, defined as any corneal staining with fluorescein
7. Presence of any central posterior capsular opacification. Previous YAG laser capsulotomy is allowed.
8. Any surgical complication having to do with the capsule such as a broken capsule or zonular dialysis or iris trauma or any other complication felt to in any way impact upon the quality of the visual result.
9. Any contraindication to pupil dilation
The Detection of Circulating Tumor Cells (CTCs) in Patients With Renal Cancer Undergoing Cryosurgery Combined With DC-CIK Treatment

Circulating tumor cells (CTCs) have the potential to provide a surrogate for'real-time biopsy' of tumor biological activity. Enumeration and molecular characterization of CTCs in renal cancer could play an important role in diagnosis, predicting the risk for tumor recurrence, and providing novel target therapy biomarkers. In view of these facts, the investigators wanted to demonstrate the value of multiparameter flow cytometry in detecting human tumor cells of renal cancer in normal peripheral blood after cryosurgery with or without dendritic cell(DC)-cytokine-induced killers(CIK) treatment, and the investigators also compared the specificity with reverse transcriptase polymerase chain reaction (RT-PCR) method.

1 day before and 2 days after cryosurgery with or without DC-CIK treatment，approximately 17-mL ethylene diamine tetraacetic acid(EDTA)-blood was drawn by vein puncture from patients with renal cancer and healthy volunteers. The blood of the healthy volunteers will be used to evaluate the sensitivity and specificity and as negative control cells. To avoid contamination with skin cells, 2 mL blood will be discarded before the study samples will be taken.Briefly, the mononucleate cells will be separated from the blood over Ficoll- Paque for 20 min with 1800g at 4℃. The interface cells will be removed and washed, and the red blood cells(RBCs) will be removed using a lysis buffer followed by a repeated wash. The mononuclear cells will be counted and aliquot for RT-PCR and multiparameter flow cytometry on the basis of at least 2-3×106 cells for each methodology. The cell pellet will be resuspended in phosphate-buffered saline for multiparameter flow cytometry and in Trizol reagent for RT-PCR. Aim : Identification of CTCs may lead to better diagnosis and prognosis and could help to choose an adequate therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Age:18-75
2. Karnofsky performance status \>60
3. Diagnosis of renal cancer based on histology or the current accepted radiological measures.
4. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
5. Will receive cryosurgery and/or DC-CIK treatment
6. Life expectancy: Greater than 3 months
7. Patients' routine blood test, liver function and kidney function have no obvious abnormalities
8. Ability to understand the study protocol and a willingness to sign a written informed consent document

Exclusion Criteria:

1. Patients with other primary tumor except renal cancer
2. History of coagulation disorders or anemia
Preemptive Analgesia for Postoperative Pain Control for Dental Treatment Under General Anesthesia

The aim of this study was to compare the analgesic-treated children with analgesic prior to the treatment and to compare the postoperative analgesic needs of children undergoing dental treatment under general anesthesia.

The investigator's study included patients who were admitted to Inonu University and Adnan Menderes University, Faculty of Dentistry, Department of Pediatric Dentistry in 2019 and decided to perform dental treatment under general anesthesia. Patients 1 to 7 years of age with dental treatment between February 28 and June 1, 2019 will be included.

Patients who underwent analgesic 15 minutes after the induction of general anesthesia from the patients, and those who made painkillers 15 minutes before the end of the treatment will constitute the control group. Paracetamol 15 mg / kg IV will be given in 50 ml of saline.

The demographic data of the children to be included in the study such as age, gender, type of dental intervention, duration of operation, postoperative pain scores, recovery times will be recorded and compared.

Eligibility Criteria:
Inclusion Criteria:

* To be treated under general anesthesia
* No systemic disease
* To have at least one painful dental procedure in the upper and lower jaw (pulpectomy, pulpotomy

Exclusion Criteria:

* Patients with mental or physical disabilities of any disease
* Patients who have not undergone painful dental intervention under general anesthesia
The Impact of Vitamin D Supplementation on Glucose Metabolism in Chinese Women With Former Gestational Diabetes Mellitus

Vitamin D deficiency are related to insulin resistance and impaired beta-cell function.It is reported that the level of vitamin D is lower during pregnancy and postpartum in the women with Gestational Diabetes Mellitus. The investigators hypothesize that vitamin D supplementation to women after birth with previous gestational diabetes may improve glucose metabolism.

Gestational diabetes mellitus (GDM) is defined as any degree of glucose intolerance that is first identified during pregnancy, excluding diabetic patients diagnosed before pregnancy. GDM can not only have an adverse effect on the pregnant women and the developing fetus, but also can have long lasting effects after birth. GDM can elevates risks of abnormal glucose metabolism postpartum. Vitamin D deficiency has been shown to be associated with insulin resistance and impaired β-cell function. Our previous research also implied that the level of vitamin D is much lower in the women of impaired glucose regulation after birth with history of GDM. This prospective randomized, control clinical trial was designed to evaluate the effects of vitamin D administration on insulin resistance and β-cell function among women with vitamin D deficiency（25OHD \<50 ng/mL）and previous GDM. Participants with vitamin D deficiency and previous GDM were divided into normal glucose regulation group(NGR) (n=90) and impaired glucose regulation group(IGR)(n=90) according to the oral glucose tolerance test (OGTT) around 42 days postpartum. And each group was further divided into intervention group and control group, Participants in the intervention group took 1600 units of vitamin D daily for nine months and meanwhile receive lifestyle intervention. The control group only receive lifestyle intervention. This study aimed to evaluate the impact of vitamin D supplementation on insulin sensitivity, pancreatic β-cell function and markers of inflammation in Chinese women with former GDM and vitamin D insufficiency.

Eligibility Criteria:
Inclusion Criteria:

1. with previous GDM,40-50 days after birth -
2. with deficiency of vitamin D(25-(OH)D3\<50nmol/L)

Exclusion Criteria:

1. type 1 diabetes，type 2 diabetes and other type of diabetes
2. server disfunction of liver and kidney（ALT \>100U/L，Cr\>132ummol/L）
3. with mental disease,sever anemia,sever infection,sever heart disease,now is taking asprin, immunosuppressive agent,Antiepileptic drugs
4. pregnancy or plan to pregnant in one year
5. can't understand the requirement of this study
6. disfunction of thyroid
DCI: A Community Based Pre-cardiac Surgery Diabetes Care Project

The Canadian Diabetes Association recommends optimizing glycemic control to achieve a glycated hemoglobin (A1C) of less than 7% in patients with diabetes. Despite these recommendations, approximately 25% of patients undergoing cardiac surgery have evidence of suboptimal glycemic control (A1C\>7%). Recent research has demonstrated that such patients experience a higher rate of post-operative complications and significantly worse short-term and long-term post-operative survival. Therefore, it is recommended that attempts should be made to improve glycemic control while patients wait for their elective surgery. However, at present processes of care that facilitate pre-operative glycemic control optimization do not exist in Canada.

The objective of this project is to determine the feasibility and effectiveness of a comprehensive community-based pre-operative diabetes optimization program for patients awaiting elective cardiac surgery.

This study is a randomized controlled trial and will investigate the feasibility and effectiveness of a pre-operative diabetes optimization program for patients with suboptimal glycemic control awaiting elective cardiac surgery. Consenting patients will be randomized to a Standard Pre-Operative Diabetes Care Group (Group 1) and a Structured Pre-Operative Diabetes Optimization Group (Group 2).

Eligibility Criteria:
Inclusion Criteria:

* Able to speak and understand English
* Age \> 18
* Able to provide informed consent
* A1C\>7%
* Placed on the waiting list for elective cardiac surgery in Manitoba

Exclusion Criteria:

* Progressive cognitive deficit or disease.
* Age \< 18
* Unable to provide informed consent
* A1C\<7%
* Undergoing emergent cardiac surgery
A Study of Imvotamab in Severe Systemic Lupus Erythematosus

The purpose of this study is to determine the safety and tolerability of imvotamab in patients with severe systemic lupus erythematosus who have failed prior therapies.

Participants will be given imvotamab through a vein (i.e., intravenously).

This is a Phase 1b, randomized, placebo-controlled, multicenter study to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of imvotamab in adult participants with systemic lupus erythematosus (SLE). Approximately 18 participants will be assigned to different sequentially dose escalation cohorts.

Eligibility Criteria:
Key Inclusion Criteria:

* Age ≥ 18 years at the time of signing ICF
* Diagnosis of SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (ACR) Classification Criteria at least 16 weeks or more prior to screening
* Highly active SLE disease, as demonstrated by a total systemic lupus erythematosus disease activity index (SLEDAI-2K) total score of ≥ 10 at screening
* Active SLE disease despite treatment with at least 1 immunosuppressive or biologic standard-of-care agent (e.g., methotrexate, azathioprine, mycophenolate mofetil, belimumab, anifrolumab) determined at the discretion of the investigator after at least 3 months of treatment.
* It must be planned that the background standard-of-care treatment remains at a stable dose throughout the Screening Period and up to Week 8.

Key Exclusion Criteria:

* Pregnant or breastfeeding or intending to become pregnant during the study or within 3 months after the final dose of imvotamab.
* Any lupus-associated neuropsychiatric disease.
* Active lupus nephritis with estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2, calculated according to the Chronic Kidney Disease Epidemiology Collaboration equation, classified as World Health Organization (WHO) Class IV.
* Prednisone-equivalent \> 30 mg/day, including immediate and extended-release oral formulations.
* Drug-induced lupus.
* Participants with a history of catastrophic or severe anti-phospholipid syndrome within 12 months prior to screening.
Prospective and Multicenter Italian Registry of Locally Advanced-Metastatic Urothelial Carcinoma

Prospective and multicenter Italian registry intended for naïve adult patients affected by locally advanced-metastatic urothelial carcinoma intended for systemic treatment, or for palliative or observation procedures

This is a multicentre, prospective and non-interventional study in which all patients treated according to clinical practice will be included. The registry will include all patients with metastatic urothelial carcinoma or with lymph node involvement defined as unsuitable for surgery. The study involves medical visits and clinical-radiological re-evaluations according to clinical practice. There are no additional procedures. The clinician will establish the number of visits necessary for each patient according to the needs encountered and depending on the treatment chosen. The participating centers were selected in such a way as to adequately represent all the different geographical areas. The duration of the study is 24 months: 12 months of enrollment plus 12 months of further follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Cytological and/or histological diagnosis of urothelial carcinoma or at least with one urothelial component originating from the genitourinary tract.
* Radiological diagnosis of metastatic or locally advanced disease inoperable
* Primary bladder, ureter, renal pelvis and of the urethra are included
* No previous chemotherapy for advanced urothelial carcinoma or metastatic disease
* Age over 18 years old
* Ability to understand and sign the informed consent
* Patients for whom the clinician has opted for a therapeutic path not including active systemic treatments (iter palliative or observation) with certain diagnosis of metastatic disease
* Patients with lymph node extension of the disease who are not candidates to neoadjuvant treatment
* Any ECOG PS and therapeutic management is permitted.
* Previous surgeries and antineoplastic treatments are permitted as long as not carried out for metastatic disease (adjuvant and/or neoadjuvant)

Exclusion Criteria:

* Patients who have received previous systemic treatment for metastatic disease
* Patients with histological and/or cytological diagnosis without urothelial component
* Patients with muscle-infiltrating disease without evidence of metastatic disease
* Patients with non-muscle infiltrating disease without evidence of metastatic disease
Evaluation of MorphoTEP With the FDG Among Patients in Severe Sepsis of Unspecified Etiology

The objective of this pilot study is to estimate a procedure where the biological samples routinely obtained at the site of suspected infection could be guided by the early realization of a TEP with FDG coupled to scanner X, in patients hospitalized in ICU for severe sepsis of unspecified etiology.

Severe sepsis constitutes the leading cause of mortality in ICU, in particular because a microbial documentation is lacking in about half of the cases.

Tomography by emission of positons, which uses the property of activated macrophages and leucocytes to collect 18F-fluorodeoxyglucose may prove useful to identify the site(s) of infection and then guide sampling.

Thirty patients will be included over 12 months.

Within 24 hours after admission, patients presented with a severe sepsis of still unknown etiology will benefit from the realization of a morphoTEP, including an examination MtOe with the FDG, associated with a conventional scanner X.

Suspected infected sites will then be the subject of sampling when possible. These samples will be send for microbial culture, histology and TREM-1 expression (membrane-bound and soluble form) when appropriate.

The main judgement criteria will be the percentage of the MtOe exams proved to be useful for diagnosis and/or associated with therapeutic modifications.

This pilot study will make it possible to evaluate the interest of the early realization of a TEP/scanner X examination among severe sepsis patients of unknown origin.

Eligibility Criteria:
Inclusion Criteria:

* Patient hospitalized with severe sepsis
* Absence of infected site clearly identified after 48 hours of a conventional diagnosis assessment or suspicion of one or more additional sites
* Indication of scanner X with injection
* Informed consent obtained

Exclusion Criteria:

* Age over 80
* Immunocompromised status
* Surgical intervention within the previous month
* Hemodynamic instability (defined by the use of more than 0.5µg/kg/min vasopressors)
* Severe hypoxia (defined by a PaO2/FiO2 ratio lower than 150)
* Pregnancy
* Patient already included in another protocol
* Anaphylaxis to Flucis
Personalized GI Motility Responses to Diet

The goal of this randomized, crossover, clinical trial is to link: 1) gastrointestinal motility patterns induced by acute consumption of whole and refined grains, 2) enteric microbial production of bioactive metabolites, and 3) circulating postprandial appearance of metabolites important to cardiometabolic health including glucose, triglycerides, and cholesterol.

Participants will be asked to consume a Smartpill monitoring device that records metrics of gastrointestinal motility in response to whole or refined grains, monitor cardiometabolic metabolties over an 8 hour postprandial window, and provide a fecal sample for microbiome-related analyses.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women

Exclusion Criteria:

Physician-Diagnosed:

* Diabetes Mellitus
* Nutrient-malabsorption disorders
* Intestinal Bowel Syndrome (IBS)
* Intestinal Bowel Disease (IBD)
* Bleeding-related disorders
* Grain allergy
* Psychological Disorders
* Stenosis
* Dysphasia

History of:

* Bariatric Surgery
* Gallbladder removal
* Eating disorders
* Antibiotic administration (within the past three months)
* Hormone therapy

Currently:

* Using statins
* Pregnant, lactating, or postmenopausal
* Taking oral hypoglycemic agents or insulin
* Ingesting prescription fiber
* Using cholesterol and bile acid absorption inhibitors
* Ingesting nutrition supplements, not including a daily multivitamin (i.e. herbs, tinctures, and extracts) •Using recreational drugs or alcohol (within the past week)
* Taking anti-histamines
* Taking proton pump inhibitors
* Taking antacids
PECS Study for CIED Implantation Surgery

We aim to determine whether pectoral nerve block (PECS) performed after induction of anesthesia but before surgical incision results less opioid use in the post operative period compared with local infiltration alone in children undergoing Cardiac Implantable Electronic Device (CIED) surgery.

The current anaesthetic management of CIED surgery at Sickkids is local anaesthetic infiltration by the EP cardiologist or a Pectoral nerve block (PECS) on an ad-hoc basis depending on the anaesthesiologist on a case by case basis. It is not known whether one technique provides better post- operative pain control and fewer adverse events than the other. In either case, the patient receives opioids as required during and after the procedure. Patients typically go home with a prescription for opioids to be taken for the first few days after surgery.

The PECS block is a recognized effective anaesthetic technique used for both intraoperative and postoperative pain control in adult breast surgery, chest wall procedures as well as one case report for CIED implantation and a small series in paediatric cardiac surgery. The advantages of the PECS block in these surgical procedures includes improved analgesia and reduced opioid use.

The investigators plan to conduct an RCT with two groups.

Group 1 will receive a PECS block (using 0.8 ml/kg of 0.25% bupivacaine with epinephrine 1: 200000 divided in two equal volumes between the two planes) by the anaesthesiologist and local infiltration (up to 0.2 ml/kg of 0.25% bupivacaine with epinephrine 1:200000) by the surgeon.

Group 2 will receive local infiltration (up to 0.8 ml/kg 0.25 % bupivacaine with epinephrine 1:200000) by the surgeon alone.

Both groups will be given opioids as rescue analgesics as deemed necessary during their procedure and as rescue analgesia postoperatively, so that no patient will have untreated pain.

Eligibility Criteria:
Inclusion Criteria:

• All patients 3-18 years undergoing CIED surgery in the chest

Exclusion Criteria:

* Children \< 3 years of age at time of procedure as bupivacaine is not licensed for this age group.
* No parental or patient consent
* Allergy to bupivacaine
* Pregnancy or lactation
* Any condition or diagnosis, that could in the opinion of the Principal Investigator or delegate interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk.