cyrilzakka/clinical-trials huggingface dataset:
Development and Validation of a Multi-Mineral Fluoride Mouthrinse

The primary goals of this project are to determine the anticaries benefits of a prototype multi-mineral mouthrinse containing 225 ppm fluoride and 30 ppm of a Ca through the remineralization of enamel white-spots (non-cavitated lesions). The selection of patients with pre-existing white-spot lesions will permit an opportunity to evaluate the efficacy of the multi-mineral mouthrinse in reminerzalizing and/or inhibiting progression of enamel white-spot lesions.


Eligibility Criteria:
Inclusion Criteria:

To participate in this study, panelists will be required to meet the following criteria:

1. Subjects must be 13 - 65 years of age;
2. Subjects must read and sign the Informed Consent prior to initiation of study procedures. All subjects will receive a copy of the signed Informed Consent;
3. Subjects must have a reasonable functional dentition, without a large number of missing teeth, and teeth #'s 22-27 present;
4. Have normal salivary gland function (unstimulated whole salivary flow rate equal to or greater than 0.25 ml/min and paraffin stimulated whole salivary flow rate equal to or at least 1.0 ml/min);
5. Subjects must be willing to participate in the study, be able to follow the study directions, be willing to return for all specified visits at their appointed time, and to use the product as per instructions;
6. Subjects must be in good general health based on medical history and oral soft and hard tissue examination.

Exclusion Criteria:

Criteria that will not permit participation in this study will be as follows:

1. Any subject who is pregnant or lactating - based on oral interview only - as pregnancy may interfere with the outcome of the study;
2. Any subject who has a systemic health condition such as diabetes that could affect the outcome of the study at the discretion of the examiner;
3. Any subject who has an oral condition, such as excessive, untreated dental caries, periodontal disease, chronic dental neglect, or any oral pathology including xerostomia determined by oral examination and subject history that in the opinion of the dental examiner could affect the outcome of the study;
4. Any subject who has full dentures, or full orthodontic appliances. No use of nightguards will be permitted during the study period;
5. Any subject who uses oral care products (other than those permitted) during the treatment or wash-out periods;
6. Any subject with an immunological disorders such as HIV positive, AIDS, and systemic Lupus Erythematosis;
7. Any subject concurrently participating in another clinical study;
8. Any subject currently taking antibiotics or other medications, which in the opinion of the Investigator/Examiner might influence the study outcome;
9. Any subject with a history of sensitivity to oral products or allergies to ingredients in the products;
10. Any subject who fails to keep any of their scheduled appointments.
Retinal Effects After Combined Photodynamic Therapy (PDT) With Intravitreal Triamcinolone

Background: To identify characteristic morphological changes of the retina, their change over time and the association with visual function after combined photodynamic therapy (PDT) and intravitreal triamcinolone (IVTA).

Methods: In this retrospective study, 40 patients (40 eyes) were treated with PDT and same day IVTA. Optical coherence tomography (OCT), fluorescein angiography (FA) and evaluation of distance visual acuity (VA) were performed. Main outcome measures were the anatomical changes within intra- and subretinal compartments and their detailed analysis and grading.


Eligibility Criteria:
Inclusion Criteria:

* cnv secondary to age related macular degeneration

Exclusion Criteria:

* glaucoma, diabetic retinopathy
One-year Patient Reported Outcomes Following Hospitalization for Trauma

This study evaluates the three, six, and twelve month patient reported outcomes of people admitted two trauma centres in western Canada over a four month period. Participants are evaluated using the Trauma Outcome Profile and a custom survey instrument.

This study intends to assess patient reported outcomes following discharge from trauma services at the Foothills Medical Centre (FMC) and Vancouver General Hospital (VGH). The investigators will survey participants with pen-and-paper surveys at three, six and twelve months following discharge from hospital. The survey instrument being used is the Trauma Outcomes Profile, which has been previously validated in this population, supplemented by a supplemental survey to help further describe resources this population has access to in their recovery. The results of these surveys will be compared with pre-injury health status, injury types, mechanisms, and discharge medications and treatments. The investigators anticipate enrolling 500 participants starting in October 2016. At the conclusion of the study the investigators will have a better understanding of patient reported functional outcomes after trauma and will be better positioned to design trauma rehabilitation systems to service this population.

Eligibility Criteria:
Inclusion Criteria:

* admitted to the trauma service at VGH or FMC
* Age 18 or older
* resident of Canada

Exclusion Criteria:

* English language literacy
* Impairments in cognition, motor, or communication that limit the ability to complete a paper-based survey
* No fixed address
LEVANTIS-0093A: GAGomes for Multi-Cancer Early Detection in High-Risk Adults (LEV93A)

LEVANTIS-0093A (LEV93A) is a prospective cohort observational clinical study to validate the plasma free GAGome MCED test in adults at high risk of developing cancer ("high-risk adults"), specifically in 55-80-year-old adults with significant smoking history.

LEV93A will use plasma biospecimens collected within the Yorkshire Lung Screening Trial Biomarker sub-study and corresponding participant data prospectively collected within the Yorkshire Lung Screening Trial (YLST) and the Yorkshire Kidney Screening Trial (YKST) all of which are sponsored by the University of Leeds and funded by Yorkshire Cancer Research (Award references: L403, L403B L403C), in collaboration with the University of Leeds, with the University of Manchester and with the Leeds Teaching Hospitals.


Eligibility Criteria:
Inclusion Criteria

* Adults aged 55-80 years old
* Significant smoking history, defined as current or ex-smokers and any of the following criteria:

  * 30 pack year history of smoking and current smoker or quit within the last 15 years (USPSTF criteria).
  * Lung cancer risk of ≥1.51% over 6 years as calculated by the PLCOM2012 score
  * Lung cancer risk of ≥5% over 5 years as calculated by the LLPv2. Score
* Consenting to participate to both YLST and YLST Biomarker trials
* Able to donate a blood sample

Exclusion Criteria

* Deemed medically unfit for sample collection
* Contraindication for study procedures or sampling
* Not consenting to participate to YKST trial
Assessment of Stress, Depression and Anxiety in Healthcare Caring for Patients With COVID-19

Medical personnel working in the Intensive Care Unit will be examined by means of tests. Their aim is to check how work-related stress in a potentially lethal threat affects the occurrence of depression, stress, anxiety and sleep disorders. We also want to check whether people working in such extremely difficult conditions show no greater interest in death.

Every day medical staff working in very difficult conditions of intensive care. The COVID-19 virus outbreak has set another difficult task for doctors and nurses who have previously had a lot of contact with the death of their patients. The appearance of the COVID-19 virus and, above all, the inability to effectively treat the infection causes an additional psychological stimulus in medical personnel.

The aim of the study is to assess the occurrence of psychiatric disorders in medical personnel dealing with patients suffering from COVID-19 using various psychological tests.

Eligibility Criteria:
Inclusion Criteria:

adult employees of the Intensive Care Unit, agreeing to undergo the tests.

Exclusion Criteria:

* patient's refusal to participate in the study
* not understanding the test questions
Myocarditis Treatment Trial

To determine whether immunosuppressive treatment improved cardiac function in patients with biopsy-proven myocarditis.

BACKGROUND:

Heart failure due to myocarditis can be a devastating illness. At the same time, immunosuppressive therapy is associated with considerable risks of untoward side effects. Clinicians did not know whether, under what circumstances, or in what form, this hazardous treatment should be used in such critically ill patients. In addition, if immunosuppressive therapy was of benefit, then endomyocardial biopsy in patients suspected of having myocarditis was a justified procedure. The trial also provided information concerning the side effects of immuno-suppressive therapy in such patients.

DESIGN NARRATIVE:

Patients were randomized into two treatment arms consisting of conventional therapy alone for congestive heart failure or combined with a twenty-four week regimen of immunosuppressive therapy. Immunosuppressive therapy consisted of prednisone with either cyclosporine or azathioprine. The primary outcome measure was a change in the left ventricular ejection fraction at twenty-eight weeks. Secondary endpoints included survival, failures of therapy, requirements for conventional therapy, assessments of symptoms, myocardial histology, and arrhythmias.

The study completion date listed in this record was obtained from the Query/View/Report (QVR) System.

Eligibility Criteria:
Men and women, 18 years of age or older, with left ventricular failure and biopsy-documented myocarditis.
Pinless-Navigated Versus Conventional Total Knee Arthroplasty

The success of total knee arthroplasty depends on a number of factors including pre-operative range of movement, obesity, medical comorbidities, prosthesis design, preparation and implantation of the prosthesis, soft tissue balancing, as well as implants alignment. Optimal placement of the implants within 3° of the mechanical axis of the lower limb has been proven to reduce wear and early implant failure.

Compared to conventional techniques, computer-Aided Navigation total knee arthroplasty has been widely used in the last decade and have been proven to improve the accuracy of prosthesis placement and lower limb alignment by reducing the number of outliers with more than 3° deviation from the mechanical axis. However, its use also involves a steep learning curve, high initial capital cost and longer duration of surgery.

Traditional computer-navigated TKA using optical tracking systems also requires fixation of the femoral and tibial reference arrays to bone using anchoring pins. Complications reported with the use of these pins include either femoral or tibial fracture, pin site pain, pin site infection and osteomyelitis. The investigators study aims to investigate the accuracy of a new pinless navigation system for TKA that will avoid these complications.

The duration of surgery and length of hospital stay were recorded for all patients. Three radiographic measurements were recorded on the coronal films: 1) Hip-Knee-Ankle Angle (HKA), the angle formed by the mechanical axis of the femur (line between the centre of the femoral head and the centre of the knee) and the mechanical axis of the tibia (line between the centre of the talus and the centre of the knee); 2) Coronal Femoral-Component Angle (CFA), the angle formed by the femoral component and the mechanical axis of the femur; 3) Coronal Tibia-Component Angle (CTA), the angle formed by the tibia base plate and the mechanical axis of the tibia. The post-operative radiographic measurements were compared with the intra-operative readings from the pinless navigation system. The accepted values used in our study for normal alignment were: 1) 0° ± 3° varus/valgus for HKA; 2) perpendicular (± 3°) to the mechanical axis of the femur; 3) perpendicular (± 3°) to the mechanical axis of the tibia.

Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 45 and 90 diagnosed with osteoarthritis of the knee and scheduled for unilateral total knee replacement.

Exclusion Criteria:

* Patients coming for revision total knee arthroplasty
* Patients diagnosed with inflammatory arthritis
Analgesic Effects of Intranasal Diclofenac Sodium, Ibuprofen, and Paracetamol in Pediatric Tonsillectomy Cases

This study aims to evaluate the efficacy and safety of intranasal Diclofenac Sodium, intranasal Ibuprofen, and intranasal Paracetamol for pain control following tonsillectomy in pediatric patients.

Postoperative pain management in pediatric tonsillectomy remains a challenge, with concerns about the safety and efficacy of available analgesic options. Intranasal administration of nonsteroidal anti-inflammatory drugs presents a promising alternative for effective pain relief with minimal side effects.

This prospective, randomized study evaluated the efficacy and safety of intranasal diclofenac sodium, intranasal ibuprofen, and intranasal paracetamol compared to intravenous paracetamol in pediatric patients following tonsillectomy. Sixty patients, aged 2 to 14 years, were divided into four groups to receive either intranasal paracetamol (Group 1), intranasal diclofenac sodium (Group 2), intranasal ibuprofen (Group 3), or intravenous paracetamol (Group 4). Pain was assessed using the CHEOPS, VAS, and Wong-Baker modified VAS scoring systems at various postoperative time points. Statistical analysis was performed using the Kruskal-Wallis and Dunn's tests.

Eligibility Criteria:
Inclusion Criteria:

-Pediatric patients who have undergone a tonsillectomy.

Exclusion Criteria:

* Chronic sinusitis
* Common cold or rhinitis
* Turbinate hypertrophy
* Nasal polyposis
* Deviated nasal septum
* Impaired mucociliary clearance
* Atrophic rhinitis
A Study of 1592U89 in HIV-Infected Children

The purpose of this study is to see if it is safe to give 1592U89 to children (aged 6 months until 14th birthday) with advanced HIV infection who have few treatment options available. The study also examines the effect 1592U89 has on the levels of HIV in the blood.

This is an open-label, non-randomized study. All patients will be treated with 1592U89. Additionally, since optimal therapy usually includes the combined use of 2 or more antiretroviral agents in advanced patients, other novel antiretroviral therapies may be accessed through commercial means or via compassionate use programs. NOTE: 1592U89 should not be administered as a single new agent added to a failing treatment regimen.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Intravenous immunoglobulin G.
* Erythropoietin, granulocyte colony stimulating factor and granulocyte macrophage colony stimulating factor, for the management of hematologic toxicity.

Patients must have:

* Documented HIV infection.
* High risk for disease progression or mortality as defined by either of the following:
* Viral load \> 100,000 copies/ml and CD4 cells \< 15% of total lymphocyte count despite at least 4 weeks of therapy with commercially available antiretrovirals or as a result of no therapy due to treatment-limiting toxicity of ZDV, 3TC, and ddI; or HIV-associated encephalopathy refractory to ZDV-containing regimen.
* No access to any 1592U89 pediatric study where the patient could qualify for inclusion.
* Parent or legal guardian with the ability to understand and provide written consent for the patient to participate in the trial. Study patients over 13 years should also give written informed consent whenever possible.

Exclusion Criteria

Co-existing Condition:

Patients with any of the following symptoms or conditions are excluded:

* In the investigator's opinion, the patient is unlikely to comply with the requirements of the study.
* Renal failure requiring dialysis.
* Hepatic failure evident by Grade 3 or 4 hyperbilirubinemia and AST \> 10 X upper limits of normal.
* Life-threatening infection or other chronic disease that may interfere with taking 1592U89 or compromise the patient's safety.

Patients with the following prior conditions are excluded:

Documented hypersensitivity to 1592U89 or any other nucleoside analogue.

See Inclusion - General Criteria.
Drug Therapy for Alcohol Detoxification

This project will provide relevant clinical information for primary care practitioners treating alcohol withdrawal syndrome in outpatient settings. This double-blind, placebo- controlled clinical trial will compare the effectiveness of lorazepam (Ativan) and carbamazepine (Tegretol) in alcoholics who meet the criteria for a diagnosis of uncomplicated alcohol withdrawal syndrome. Participants are randomized to five days of treatment with a 1-week posttreatment followup.


Eligibility Criteria:
Inclusion Criteria:

* Meets criteria for alcohol dependence and uncomplicated alcohol withdrawal syndrome.
* Ability to provide informed consent, complete self-rating questionnaires, and respond to structured clinician-rated instruments.
* Must live within 50 miles or one hour of the study site and have reliable transportation to the site.
* Must have a significant other who will provide a collateral report, attend outpatient visits, and be available by telephone.
* Subjects must be medically stable.
* Must have a clinical withdrawal assessment prior to study.

Exclusion Criteria:

* Meets criteria for any other substance dependence syndrome other than alcohol dependence or marijuana abuse.
* Use of other illicit psychoactive substances (except marijuana) in the last 7 days.
* Use of pharmaceutical agents within the last 14 days that are known to lower the seizure threshold, augment or decrease the alcohol withdrawal syndrome.
* History of status epilepticus or two or more seizures occurring within 24- hour period during a previous alcohol withdrawal or other forms of epilepsy.
* Current major depressive illness, dementia, suicidal or homicidal ideation, or past or present schizophrenia.
* Acute medical instability as characterized by hepatic encephalopathy, past or present severe liver failure.
* Diabetes requiring insulin, or severe renal disease.
* Pregnant females.
* High blood pressure.
* Individuals with vomiting who cannot take oral medications at beginning of study or whose vomiting can be controlled only with antiemetic medication.
* High white blood count, or liver function test that is 3 times higher than normal.
* Known hypersensitivity or previous adverse reaction to carbamazepine, lorazepam, or other benzodiazepines.
* Any relevant ECG abnormality which might require hospitalization or greatly interfere with safety during outpatient withdrawal.
* History of severe gastrointestinal (GI) disease which might render absorption of the medication difficult or produce medical instability of the patient during detoxification which would include active peptic ulcer disease, ulcerative colitis, regional ileitis, or evidence by history or physical examination of GI bleeding.
* Familial tremor or other neurological condition, determined by history, known to produce tremor.
* Unable to provide a written informed consent.
Prevention of Perioperative Acute Renal Failure

The purpose of this study is to measure the acute renal dysfunction on the first, second, seventh and twentieth days.


Eligibility Criteria:
Inclusion Criteria:

* All patients who are undergoing elective abdominal surgery after appropriate information of the study, and its possible risks that may arise therefrom and that at any time to refuse their cooperation, give a written consent to participate in the study.
* Patients who at the time of the interview have an ASA between 2 and 4.
* Patients with chronic kidney failure mild moderate (serum creatinine between 1.5 and 3.0 mg / dl) can be included.

Exclusion Criteria:

* Chronic kidney diseases with serum creatinine higher than 3.0 mg /DL
* Laparoscopic abdominal surgery
* ASA 1 and ASA 5 patients.
* Patients with cardiac insufficiency, ascites and respiratory insufficiency
* Diastolic hypertension \> 100 mmHg
The Impact of Probiotic Bacteria on the Efficacy of Anti-retroviral Therapy and Recurrence of Bacterial Vaginosis

Purpose of the proposed research is to determine the impact of probiotic yogurt supplemented with Lactobacillus rhamnosus (Fiti) compared to regular yogurt on the well-being of women living with HIV.


Eligibility Criteria:
Inclusion criteria:

* Confirmed HIV infection;
* Being treated with anti-retroviral medication for \> 6 months.

Exclusion criteria:

* Pregnancy;
* Hypersensitive to fermented milk;
* Intolerant for lactose;
* Complaints of bacterial vaginosis requiring treatment
Green Dialysis: Dialysis With Reduced Dialysate Flow

Hemodialysis patients consume per year 18.720-26.208L of dialysis fluid (i.e. water). From an ecological point of view, the present study investigated whether reducing this water amount has an impact on the extraction and total solute removal of different uremic toxins. The efficiency of hemodiafiltration with a standard high-flux dialyzer is compared to hemodialysis with a medium cut-off dialyzer with a dialysate flow of either 700mL/min or 300mL/min.

Hemodialysis is currently performed with dialysate flows in the range 500 and 700mL/min respectively in hemodialysis and hemodiafiltration mode. With a standard daytime dialysis scheme of three times four hours a week, each patient consumes up to 360-504L dialysate per week or 18.720-26.208L per year.

From an ecological point of view, one can wonder whether patients can be dialyzed adequately enough using hemodialysis mode with a lower dialysate flow, and as such consuming less water.

Changing the mode from hemodiafiltration to hemodialysis mainly has an impact on the removal of larger toxins which benefit of the convective transport. Lowering dialysate flow in hemodialysis mode mainly has an impact on the removal of small water soluble toxins which are mainly removed by diffusion. For this transport, different parameters are important: blood and dialysate flow, dimensions of the membrane (surface area and thickness), fiber diameter, and extra-luminal space, and membrane porosity (Sieving coefficient). This also implies that, for the same blood and dialysate flow, the choice of the dialyzer will determine toxin transport. The use of a medium cut-off membrane with smaller and more open fibers might thus be more adequate in hemodialysis mode than a standard high-flux dialyzer with wider fibers.

The aim of this study is to quantify instant extraction and overall total solute removal of representative uremic toxins in hemodiafiltration with a standard high-flux hemodialyzer versus hemodialysis with a medium cut-off membrane, either with a standard or reduced dialysate flow.

Eligibility Criteria:
Inclusion Criteria:

* stable chronic hemodialysis patient
* well functioning vascular access

Exclusion Criteria:

* active infection
* malignancies