cyrilzakka/clinical-trials huggingface dataset:
Study of NV-101 for Safety and Efficacy in Pediatric Dental Patients Undergoing Procedures

This Phase 2 clinical study is designed as a multicenter, randomized, blinded, controlled study to evaluate the safety and efficacy of NV-101 in approximately 150 children 4 to 11 years of age. NV-101 or sham injection is administered at the completion of a dental procedure requiring local anesthesia with 2% lidocaine with 1:100,000 epinephrine. The dental procedure(s) shall be performed in a single quadrant of the mouth and include cavity preparation, restoration/filling, teeth cleaning (non-surgical scaling and/or root planing), or crowns.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 4 to 11 years of age
* Sufficiently healthy, as determined by the Investigator, to receive routine dental care
* Requires a restorative procedure such as cavity preparation, or such as teeth cleaning (non-surgical scaling and/or root planing) in a single quadrant of the mouth
* Requires local anesthesia with 2% lidocaine with 1:100,000 epinephrine administered by submucosal injection
* Dental procedure(s) completed with 60 minutes of injection of local anesthetic
* Can be trained to complete the Wong Baker Pain Rating Scale
* For subjects 6 to 11 years of age who are trainable in standardized palpation procedure:

  * have normal lip sensation at baseline prior to administration of local anesthetic
  * have numbness of the relevant lip quadrant at completion of the dental procedure
* Negative urine pregnancy test at screening in female subjects who are past menarche
* Subjects give written or verbal assent, as applicable, and parents(s) or legal guardian(s) give written informed consent

Exclusion Criteria:

* Weight less than 15 kg
* History or presence of any condition that contraindicates routine dental care or use of local anesthetic
* Requires more than half cartridge of local anesthetic if weight is greater than or equal to 15 kg and less than 30 kg and more than one cartridge of local anesthetic if weight is greater than or equal to 30 kg, excluding supplemental injections
* Allergy or intolerance to lidocaine, epinephrine, sulfites, phentolamine, or topical benzocaine
* Has used any investigational drug and/or participated in any clinical study within 30 days of study drug administration
* Has participated in this study or any previous study of phentolamine mesylate for reversal of local soft tissue anesthesia (STA)
* Use of opioid-like analgesics within 24 hours prior to administration of local anesthetic
* Requires the use of local anesthetic other than lidocaine/epinephrine to perform the scheduled dental procedure
* Requires the use of nitrous oxide or sedatives to perform the scheduled dental procedure
* Any condition which, in the opinion of the Investigator, increases the risk to the subject of participating in the study or decreases the likelihood of compliance with the protocol
Feasibility Study of the NEW NORMA-SENSE

* In-vitro study
* Collect data regarding the color appearance on the new developed indicator strips (NEW NORMA-SENSE), in contact with vaginal secretion with elevated pH
* Measure the buffering capacity of vaginal secretion from non-symptomatic and symptomatic subjects
* Detect these indicator strips' performance, in contact with urine

This in-vitro study was designed to collect data regarding the color appearance on the new developed indicator strips (NEW NORMA-SENSE) when coming in contact, in-vitro, with vaginal secretion with elevated pH, and to measure the buffering capacity of vaginal secretion from non-symptomatic subjects and symptomatic subjects, and to detect these indicator strips' performance when come in contact with urine.

Eligibility Criteria:
Inclusion Criteria:

1. Women, aged between 18 and 45, with or without symptoms of vaginal infection.
2. Subjects are ready to sign the informed consent form.

Exclusion Criteria:

1. Subjects are unable or unwilling to cooperate with the study procedures.
2. Subjects are currently participating in another clinical study that may directly or indirectly affect the results of this study.
3. Subjects that suffer from vaginal bleeding or menstruate.
4. Subjects that have had sexual relations within the last 12 hours.
5. Subjects that applied local antiseptic, antibiotic or vaginal treatment within the last 3 days.
6. Subjects that applied vaginal douching within 12 hours prior to the visit at the clinic.
Coenzyme Q10 Supplementation in Children With Idiopathic Dilated Cardiomyopathy

This study aims to determine the effect of Coenzyme Q10 supplementation on conventional therapy of children with heart failure due to idiopathic dilated cardiomyopathy.

This study aims to determine the effect of Coenzyme Q10 supplementation on conventional therapy of children with heart failure due to idiopathic dilated cardiomyopathy. In a prospective, randomized, double-blinded, placebo-controlled trial, patients younger than 18 years with idiopathic dilated cardiomyopathy randomizes to receive either Coenzyme Q10 or placebo. Echocardiographic systolic and diastolic function parameters are determined for every patient at baseline, after three,six and nine months of supplementation.

Eligibility Criteria:
Inclusion Criteria:

* Known cases of Idiopathic Dilated Cardiomyopathy (IDC)
* Those patients in whom heart failure medications were stable for at least 1 month
* More than 6 months aged

Exclusion Criteria:

* Recent modification in medications
* Hemodynamic instability
* Congenital heart disease
* Metabolic heart disease
* Cardiac dysfunction resulting from abnormalities in other organs and those with an acquired cardiomyopathy
THE FRENCH NATIONAL NAFLD COHORT (FRench pAtients With MEtabolic Steatosis)

The main objective of this cohort study is to determine genetic, clinical biologic and metabolic factors associated with patient heterogeneity in regards to severity of NAFLD at diagnosis as well as during the clinical course.

* at diagnosis, with the aim to better characterize patients of different severity and improve our understanding of clinical and histological heterogeneity at diagnosis
* during the clinical course to better understand and predict disease progression in terms notably of fibrosis progression and progression to cirrhosis

Non-alcoholic fatty liver disease (NAFLD) is considered the hepatic manifestation of metabolic syndrome and is currently the most common cause of liver disease in many developed countries worldwide.

The aim of the study is to improve the scientific knowledge on markers associated with disease severity and progression in NAFLD.

The study is a multicentre French NAFLD cohort of well-characterized patients with biological samples covering the entire spectrum of NAFLD severity (steatosis, NASH, significant fibrosis, cirrhosis, hepatocellular carcinoma).

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years
2. Patients with a confirmed diagnosis of NAFLD
3. Patients affiliated to French social security
4. Written informed consent signed by the patient

Exclusion Criteria:

1. Refusal or inability (lack of capacity) to give informed consent.
2. Average alcohol ingestion greater than 21/14 units/week (males/females) in the preceding 6 months or history of sustained excessive consumption of alcohol in past 5 years.
3. History or presence of Type 1 diabetes mellitus.
4. Presence of any other form of chronic liver disease except NAFLD
5. Recent (within 12 months) or concomitant use of agents known to cause hepatic steatosis (long-term systemic corticosteroids \[\>10 days\], amiodarone, methotrexate, tamoxifen, tetracycline, high dose oestrogens, valproic acid).
6. Any contra-indication to liver biopsy.
7. Recent (within 3 months) change in dose/regimen or introduction of Vitamin E (at a dose ≥400 IU/day), betaine, s-adenosyl methionine, ursodeoxycholic acid, silymarin or pentoxifylline.
8. Non-French speaking/unable to access an interpreter.
9. Patients judged by the investigator to be unsuitable for inclusion in the study (e.g. judged by the physician as unlikely to be compliant with the study protocol).
10. Pregnant or breastfeeding women
11. Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom
Treatments for COVID-19: Canadian Arm of the SOLIDARITY Trial

This study is an adaptive, randomized, open-label, controlled clinical trial, in collaboration with countries around the world through the World Health Organization.

Subjects will be randomized, across one, two, three or up to four separate randomizations, to receive either standard-of-care products or the study medication plus standard of care, while being hospitalized for COVID-19.

Randomization WHO: Imatinib vs Infliximab vs Artesunate vs Standard of care

Randomization Dex: Dexamethasone vs Standard of care

Randomization LSALT: LSALT Peptide vs Standard of care

Hospitalized subjects will require blood sampling for screening and on days 1 and 5.

Eligibility Criteria:
Inclusion Criteria:

Each participant must meet all of the following inclusion criteria to participate in this study:

1. ≥ 18 years of age
2. Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen, within 14 days prior to randomization.
3. Hospitalized at a participating centre
4. Primary reason for hospitalization or subsequent in-hospital illness is because of acute COVID19 infection
5. First admission for acute COVID19

In addition, there will be the below intervention-specific inclusion:

Randomization WHO will have no other specific inclusion criteria.

Randomization LSALT will have no other specific inclusion criteria.

Randomization Dex will have the following specific inclusion criteria

1. On 10 days of steroid course and
2. Receiving any supplemental oxygen for 10 days

Exclusion Criteria:

All participants meeting any of the following exclusion criteria at baseline will be excluded from participation in this study:

1. Anticipated transfer to another hospital, within 72 hours, which is not a study site
2. Expected to not survive beyond 24 hours
3. Receiving one of the study drugs at time of enrolment

In addition, there will be the below intervention-specific exclusions:

Randomization WHO:

These will be drug-specific exclusions; patients will still be eligible for randomization in Randomization WHO to the other available study drugs (in randomization WHO or subsequent randomizations).

Artesunate:

1. Known hypersensitivity to artesunate

Imatinib:

1. Pregnant or breastfeeding;
2. Known hypersensitivity to imatinib;
3. Liver transaminases (either ALT or AST) \> 5x upper limit of normal

Infliximab:

1. Known moderate or severe heart failure, per treating clinician, defined as New York Heart Association (NYHA) class III or IV
2. Known or suspected active tuberculosis
3. Known hypersensitivity to infliximab

Randomization LSALT:

1. Known hypersensitivity or prior use of LSALT peptide.
2. Pregnant or breastfeeding

Randomization Dex:

1. Receiving glucocorticoids for a specific, non-COVID-19 indication
Evaluation of the Efficiency and Complications of the Consequtive Proning in Covid -19 ICU

Thirty -one confirmed Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2 ) infected patients with Acute Respiratory Distress Syndrome (ARDS) and placed in prone position(PP) for 3 times (PP1, PP2, PP3)consecutively will be included. Arterial blood gases (ABG), partial pressure of arterial oxygen/ fraction of inspired oxygen (PaO2/FiO2 ) ratios, partial pressure of carbondioxide (PaCO2), positive end expiratory pressure (PEEP), and fraction of inspired oxygen (FiO2) values will be recorded before (bPP), during (dPP)and after (aPP) every prone positioning. Eye, skin, nerve and tube complications related to prone positions wll be recorded


Eligibility Criteria:
Inclusion Criteria:

a positive test result for SARS-CoV-2 RNA through nasopharyngeal swab and underwent three subsequent prone positions for 16 hours will be enrolled the study. -

Exclusion Criteria:

negative test result for SARS-CoV-2 RNA -
Intervention to Improve Care at Life's End

The BEACON trial (Best Practices for End-of-Life Care for Our Nations' Veterans) was a six-site implementation study to evaluate a multi-component, education-based intervention to improve the quality of end-of-life care provided in VA Medical Centers.

The BEACON trial (Best Practices for End-of-Life Care for Our Nations' Veterans) was a six-site, real-world implementation trial of a multi-component, education-based intervention to improve the quality of end-of-life care conducted in VA Medical Centers (VAMCs).

The primary aim was to evaluate the effectiveness of a multi-component intervention for improving processes of care provided in the last days of life in VAMCs. The second aim was to conduct after-death interviews with next-of-kin and qualitative analysis of their perceptions of the care provided to the veteran and family.

The multi-component intervention targeted VAMC inpatient providers, including physician, nursing, and ancillary staff. It consisted of preparatory site visits, a staff training program, a newly developed Comfort Care order set decision support tool built into the CPRS, and follow-up consultation. The intervention team travelled to each site to conduct two weeks of comprehensive in-service training. Staff were trained to identify actively-dying patients and implement a set of best practices of traditionally home-based hospice care for dying patients. The team provided assistance with policies, procedures, and skill training needed to implement comfort care interventions. Introduction of the intervention at each VAMC was staggered across time at six-month intervals using a multiple-baseline, stepped wedge design.

Data on processes of end-of-life care (last 7 days) were abstracted from the CPRS medical records of all veterans who died before, during, and after the intervention (January 2005-February 2011). A priori, five processes of care were identified as primary endpoints to indicate quality of end-of-life care: 1) presence of an order for opioid pain medication at time of death; 2) a do-not-resuscitate (DNR) order in place at time of death; 3) location of death; 4) presence of enteral feeding tube or intravenous line at time of death; and 5) physical restraints in place at or near time of death.

In addition, in-depth, face-to-face interviews were conducted with 78 bereaved next-of-kin.

Eligibility Criteria:
Inclusion Criteria:

* Aim 1: Not applicable. Patients were deceased.
* Aim 2: After-death interviews with next of kin: must be willing and able to participate in after-death interview at local VA Medical Center.

Exclusion Criteria:

* N/A
Assessment of Conventional and Patient-specific Instrumentation in Total Knee Arthroplasty

This study will use a special type of x-ray called radiostereometric analysis (RSA) imaging to determine whether patient-specific instrumentation for total knee arthroplasty (replacement) has an effect on implant loosening compared to conventional instrumentation. Secondary objectives will include assessment of post-operative implant alignment, patient satisfaction, operative time and surgical instrument use, cost, and environmental impact.

This is a prospective randomized controlled trial which will enroll 50 patients undergoing total knee replacement surgery. All study patients will undergo an MRI prior to surgery. Half (25)of these patients will be randomized to have their MRI used to develop a patient-specific instrument to be used during their surgery. The other half (25) will have conventional instrumentation (CI) used for their knee replacement surgery.

All patients will have the same type of knee implant used for their total knee replacement (Genesis II posterior stabilized (Smith \& Nephew).

Patients will not know which group they have been randomized to. For patients randomized into the patient-specific randomization group, If the surgeon is not happy with the patient-specific instrumentation, they have the option to switch to conventional instrumentation at any time during the surgery.

• Length of operation, number of instruments used, amount of OR room waste and number and type of adjustments to the patient specific instrumentation will be tracked.

During the surgery, all patients in the study will have tantalum marker beads placed in the bone surrounding their knee replacement. These beads will be used as markers to measure implant fixation over the next two years. All patients will undergo a special type of x-ray imaging called RSA imaging to quantify implant fixation over time.

RSA examinations will occur at 6 weeks, 3 months, 6 months, 1 year, and 2 years at the Robart's Research Institute after their standard of care visit with orthopaedic surgeon.

Model based RSA software used to measure motion of implant components relative to bone markers.

All patients will complete our standard outcome measures in the form of surveys completed at their follow-up visits after surgery. •

Eligibility Criteria:
Inclusion Criteria:

* Undergoing primary total knee replacement surgery
* No previous knee hardware (ie.Uni-Knees, or high tibial osteotomy)
* BMI \< 40
* Study patients should live within 100 km of our facility to ensure availability for follow-up

Exclusion Criteria:

* Pregnancy or considering pregnancy
* BMI \> 40
* Unable to undergo MRI screening
A Comparative Study of the Effects of QS-M Needle Free Injector and Glargine Pen Subcutaneous Injection of Insulin Glargine on Insulin Use

A clinical study of the use of glargine insulin in 2 subjects with type two diabetes in China was carried out. The two kinds of injection methods were evaluated as subcutaneous injection of insulin glargine.


Eligibility Criteria:
Inclusion Criteria:

1. male or female aged 18-70 years of age, women of childbearing age need to take adequate contraceptive measures to minimize the risk of pregnancy;
2. the standard of diagnosis of type 2 diabetes and the course of the disease is more than half a year;
3. 18 Kg/m2 = BMI = 30Kg/m2;
4. received daily injections of insulin glargine and also take one to three kinds of oral medicine (not including secretagogues) patients, daily insulin glargine total dose more than 12IU but \<50IU, the use of insulin glargine than in January;
5. the blood glucose in the fasting vein was in 5.0-9.0mmol/L;
6. the letter of informed consent has been read and signed.

Exclusion Criteria:

1. there is conflict of interest with this research.
2. blood glucose control is not good enough to participate in this study, such as repeated hypoglycemia, diabetic ketoacidosis or hyperosmolar coma.
3. serious diabetic complications such as diabetic foot, diabetic nephropathy and so on;
4. severe cardiovascular events occurred in the last 6 months.
5. the application of hormone or immunosuppressant, or low immunity defect;
6. the use of non steroidal anti-inflammatory drugs;
7. the use of sulfonylureas and insulin secreting agents;
8. a person with a history of cancer;
9. a history of unstable or rapid progressive renal disease;
10. an unstable history of major mental illness;
11. the history of hemoglobin (such as sickle red cell anemia, thalassemia, iron granulocytic anemia);
12. women who are pregnant or are breastfeeding;
13. in the near future there is a clear infection, such as urinary tract infection and pneumonia;
14. recent important visceral hemorrhage, such as gastric hemorrhage and cerebral hemorrhage, etc.
15. skin diseases such as exfoliative dermatitis, pustular sore and infection of pyogenic bacteria;
16. the history of acute pancreatitis or pancreatectomy;
17. the researchers believe that it may lead to any situation in which the subject is unable to complete the study or may cause significant risk to the subject.
18. the results of the laboratory examination are as follows: A. obvious abnormal liver function or in the active phase of the disease (AST\> 3 times the upper limit of normal ALT\> or 3 times the upper limit of normal); The creatinine clearance rate of B. was \<60ml/min; C. anaemia caused by any cause of the disease; The results of pregnancy test in women of childbearing age of D. were positive.
Timing for Arteriovenous Fistula Creation and Its Effect on Target Organs in Patients With Chronic Renal Failure

The timing for arteriovenous fistula (AVF) creation and its effect on target organs in patients with chronic renal failure will be investigated by multicenter prospective cohort. Lower estimated glomerular filtration rate (eGFR) patients (eGFR\<10ml/min 1.73m2 for patients without diabetic kidney disease, and eGFR\<15ml/min 1.73m2 for diabetic kidney disease) and higher eGFR patients (eGFR 10-15ml/min 1.73m2 for patients without diabetic kidney disease, and eGFR 15-20ml/min 1.73m2 for diabetic kidney disease) will be proposed to undertake AVF creation. Maturation rate and time of AVF will be followed up in 3 months; primary and secondary patency rate of AVF, AVF construction on cardiac structure, function, encephalopathy, cerebral vascular lesions and cognitive function will be followed up in the next 2 years. This multicenter will provide evidence to develop guideline of timing for AVF creation


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic renal failure, without AVF creation;
* Estimated glomerular filtration rate (eGFR) \<15ml/min 1.73m2 for patients without diabetic kidney disease, and eGFR\<20ml/min 1.73m2 for diabetic kidney disease;
* All study subjects must agree to participate in the study and provide written informed consent.

Exclusion Criteria:

* Patients with the history of arteriovenous graft, or central venous catheter, or peritoneal dialysis catheter placement;
* Contraindications to AVF construction:

  * Allen's Test is positive, or arterial diameter\<2 mm; venous diameter\<2.5 mm or venous occlusion/stenosis.
  * Local infection.
* Have any other uncontrolled medical condition (severe heart failure, malignancy, severe coagulation disorders ).
* Mental illness that makes the patients unable to complete the trial.
* Female who is planning to become pregnant, who is pregnant and/or lactating, who is unwilling to use effective means of contraception.