cyrilzakka/clinical-trials huggingface dataset:
Prodigy, a Level 2 Sleep Study Device, Validation Study

The Prodigy system, developed by Cerebra Medical Ltd, allows for the generation of the same information in the home that is currently only obtained in in-laboratory studies.

The objective of the current study is to demonstrate that the signals obtained by this comprehensive, portable system are comparable to those obtained in in-laboratory studies.

This study consists of obtaining standard polysomnography signals concurrently by the Prodigy 2 and by the standard commercial systems used in the Sleep Disorders Clinic (Alice G3) in Hamilton, ON and the St. Charles Sleep Disorders Center (Nihon Kohden) in Port Jefferson, NY. 42 patients will be recruited from each of the two sites, for a total of 84 patients. Questionnaires on demographics and mental health, including the Depression Anxiety Stress Scale-21, questionnaires on sleep and fatigue including Pittsburgh Sleep Quality Index, Insomnia Severity Index, and Epworth Sleepiness Scale and questionnaires on quality of life including the Functional Outcomes of Sleep Questionnaire-10 (FOSQ-10) and the Euroquol 5D-5L will be completed online using a survey platform (Qualtrics or RedCap).

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing a diagnostic sleep test

Exclusion Criteria:

* in-hospital patients
* subjects who self-report a previous diagnosis of neuromuscular disorders, obesity hypoventilation, or severe lung disease
* subjects who are not fluent in English, or who have special communication needs
* subjects who have dementia/Alzheimer's disease
* subjects with comorbid violent parasomnias
* subjects requiring additional assistance or who have limited ability follow commands.
Cardiac Remote Ischemic Preconditioning Before Elective Major Vascular Surgery

Vascular surgery is considered a high-risk operation with an anticipated risk of major cardiovascular complications in excess of 5%. The occurrence of a cardiovascular complication after surgery carries a long-term higher mortality risk. The main objective of this investigation is to reduce the proportion of patients having major cardiovascular complications during surgery through a clinical protocol of remote preconditioning that is safe, effective and reproducible.


Eligibility Criteria:
Inclusion Criteria:

* Eligible patients would be those undergoing elective major vascular surgery at the Minneapolis VA Medical Center for an expanding abdominal aortic aneurysm, obstructive carotid disease, and/or chronic limb ischemia during the study period. All patients must be ≥ 18 years of age and provide written informed consent.

Exclusion Criteria:

* Exclusion criteria include hypertensive crisis, acute coronary syndrome in the preceding 6 weeks, severe valvular heart disease, peripheral arterial disease of the upper extremities, manifested by a systolic blood pressure difference greater than 20 mmHg, pregnant women, patients unable to understand the consent process due to mental illness, advanced malignancy with limited life expectancy (\<1 year), and hemodialysis with a fistula in the upper extremity.
An Evaluation Of The Fitting Success Rate Of Senofilcon A Soft Contact Lenses In Three Designs.

This study will compare the on-eye fitting characteristics of three types of contact lenses. Each lens pair will be worn for 30 to 45 minutes before assessment and the results will be compared to mathematically calculated fitting characteristics.

This will be an approx. 40-60 subject, one-day, double-masked, randomised, repeated measures study. Each subject will wear the three lens types bilaterally in random succession, a total of six lenses will therefore be worn by each subject (3 per eye).

Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years.
* Able to read, comprehend and sign an informed consent.
* Willing to comply with the wear and study assessment schedule.
* Spherical distance prescription between -0.50 and -6.00 (inc.).
* Astigmatism, if present,≤1.50DC in both eyes.
* Have normal eyes with no evidence of any ocular abnormality or disease. For the purposes of this study a normal eye is defined as one having:

A clear central cornea. No anterior segment disorders. No clinically significant slit lamp findings (i.e. corneal oedema, significant staining, central scarring, infiltrates, active neovascularisation). No other active ocular disease (including pterygia).

Exclusion Criteria:

* Previous anterior ocular surgery
* Any active corneal infection, injury or inflammation

  . •Large pinguecula likely to affect soft lens fit
* Systemic or ocular disease or medication which might interfere with CL wear
* Pregnancy or breastfeeding
* Participation in any concurrent trial
Early Identification of Markers in Alzheimer's Families / ALFA

The ALFA study is a long term, prospective, observational study of AD patients' adult children aimed at studying and characterizing key physio-pathological features of the preclinical phase of AD.

The natural history of AD includes an asymptomatic or preclinical phase characterized by pathological cerebral alterations without any evident symptoms of the disease. The beginning of the preclinical phase can be detected using a series of biological and neuroimaging markers that indicate the presence of Aβ deposition in the brain. A variety of factors such as inflammation, genetic load (e.g., APOE4), diet, cardiovascular risk, sleep disorders and cognitive reserve, produced by endogenous or exogenous factors, vary among individuals and may determine the beginning and evolution of the preclinical phase of the disease. It is possible to identify subclinical, biological, cognitive and neuroimaging changes, in the AD preclinical phase. The longitudinal study of intra-individual changes will be more sensitive than cross-sectional inter-individual studies to detect the cognitive evolution during the AD preclinical phase. Similarly, it would be possible to identify factors in subjects at the preclinical phase that will influence their evolution to the clinical stage of the disease.

The study will start with a screening of 3.000 recruited volunteers (NCT01835717) complying as much as possible with study selection criteria and perfectly aware of the study needs.

The selected 400 participants fulfilling the inclusion criteria will undergo detailed phenotyping consisting in: clinical history, AD family history, full cognitive evaluation, cognitive reserve determination, CSF sample collection, blood and urine sample collection, neuroimaging (MRI), quality of life and habits of life questionnaires (physical activity, diet, sleeping habits, social activity, toxics habits, pollution exposure).

The longitudinal study will consist in a every 3-year follow-up visit in which the participant will undergo a review of the clinical history data, a full cognitive evaluation, neuroimaging (MRI), samples collection (blood, urine, CSF) and update of the life habits changes.

Eligibility Criteria:
Inclusion Criteria:

* Adult children of AD patient: First-degree descendant of an AD patient (following diagnosis as define in protocol).
* Age: 45 to 64 years old.
* Long-term commitment to the study: baseline and follow-up visits. Potential participants have to agree to undergo to all the procedures described in the protocol.

Exclusion Criteria:

* Cognitive impairment: to be included the participant must show no signs of objective cognitive impairment.
* Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol.
* Illiteracy or functional illiteracy.
* Any contraindication to any test or procedure at the time of study inclusion.
* Family history of monogenic AD.
* Not willing to undergo one or more of the tests and procedures described in the protocol at baseline.
Comparison of Three Soft Bifocal Contact Lenses

The primary purpose of the study is to compare the performance of three soft bifocal contact lenses in terms of the vision provided by the lenses.


Eligibility Criteria:
Inclusion Criteria:

* The subject must between 35 and 70 years of age.
* The subject must respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire" or be already wearing presbyopic contact lens correction ( e.g. reading spectacles over contact lenses, multifocal or monovision contact lenses etc.).
* The subject's spherical equivalent distance refraction must be in the range of -1.00 to -6.00 in each eye.
* Refractive cylinder must be less than or equal to -0.75 D in each eye.
* The subject must have an add power of +0.75D to +2.50D in each eye.
* The subject must have best corrected visual acuity of 20/20-3 or better in each eye.
* The subject's must have at least 20/30-distance vision with the study contact lenses.
* The subject must agree that they are comfortable with their vision prior to being dispensed the study lenses.
* The subject must be an adapted soft contact lens wearer in both eyes.
* The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
* The subject must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form.

Exclusion Criteria:

* Ocular or systemic allergies or disease that may interfere with contact lens wear.
* Systemic disease, autoimmune disease or use of medication, which may interfere with contact lens wear.
* Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear.
* Clinically significant (grade 3 or 4) tarsal abnormalities that might interfere with contact lens wear.
* Any ocular infection.
* Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
* Pregnancy or lactation
* Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV).
* History of diabetes. History of binocular vision abnormality or strabismus.
Risk Factors for Acute Kidney Injury in Diabetic Patients

incidence of AKI in diabetic patients seems to be influenced by multiple risk Factors like severe infections, elderly, poor diabetic control, previous AKI, chronic kidney disease and drugs like SGLT2-I increase risk of AKI in diabetic patients.

The incidence and prevalence of diabetes mellitus (DM) have increased over the last 20 years. The defining feature of diabetes mellitus (DM) is the presence of hyperglycaemia . mostly due to the progressively increasing prevalence of obesity and the metabolic syndrome, Current prevalence of DM worldwide is estimated to be about 390 million people . The Cardiovascular complications increase morbidity and mortality in diabetic patients. About 40% of end-stage renal disease on regular dialysis are diabetic . Acute kidney injury (AKI) Is a fundamental problem in hospitalized patients; its incidence has been reaching 20% in middle-Europe . About 50% of patients presented with AKI are found to be diabetic ; which may indicate a direct relationship between the two conditions. In 2012, a clinical practice guideline published by Kidney Disease: Improving Global Outcomes (KDIGO) provided a unifying definition and staging system for AKI . On the other hand, incidence of AKI in diabetic patients seems to be influenced by multiple risk Factors like severe infections, elderly, poor diabetic control, previous AKI, chronic kidney disease and drugs like SGLT2-I increase risk of AKI in diabetic patients. We aim in this study to identify the most common risk factors for AKI in diabetic patients and how those risk factors affect morbidity and mortality in patients with DM who developed AKI.

Eligibility Criteria:
Inclusion Criteria:

-

Inclusion criteria for the cases :

200 Diabetic patients of 18 year and older (either type 1or 2) presented by AKI based on KIDIGO Definition \& Staging. KDIGO definition of AKI: Increase in serum creatinine by ≥0.3 mg/dL (≥26.5 µmol/L) within 48 h, or Increase in serum creatinine to ≥1.5 times baseline that is known or presumed to have occurred within the prior 7 days, or Urine volume \<0.5 mL/kg/h for 6 h.

KDIGO staging of AKI: (1) stage 1: Serum creatinine 1.5-1.9 × baseline or ≥0.3 mg/dL (≥26.5 µmol/L) increase / Urine output \<0.5 mL/kg/h for 6-12 h (2) stage 2; Serum creatinine 2.0-2.9 × baseline / Urine output \<0.5 mL/kg/h for ≥12 h (3) stage 3: Serum creatinine 3.0 × baseline, increase in serum creatinine to ≥4.0 mg/dL (≥353.6 µmol/L), initiation of renal replacement therapy, or, in patients \<18 years, decrease in eGFR to \<35 mL/min per 1.73 m2 / Urine output \<0.3 mL/kg/h for ≥24 h or anuria for ≥12 h .

Inclusion criteria for matched controls 200 Diabetic patients of 18 year and older with no AKI (either type 1or 2)

Exclusion Criteria:

Exclusion criteria for cases and controls:

1. Non-Diabetic patients with AKI
2. Diabetic patients with:

   * HBS Ag, HCV, HIV
   * Active Lupus
   * Active Malignancy
   * Acute or Chronic Liver Disease
   * Acute poisoning
Ultrasonography Assessment of Septic Arthritis on Native Joint

The aim of this trial is to study the interest of ultrasonography among patients with septic arthritis.

Currently, ultrasonography is useful for detecting small fluid effusions, for examining otherwise inaccessible joints, such as the hip and for helping the joint aspiration.

Accurate assessment of disease activity and joint damage in septic arthritis is important for monitoring treatment efficiency and for prediction of the outcome of the disease.

Nowadays, magnetic resonance imaging (MRI) provides better resolution than radiography or tomography for the detection of joint effusion and for differentiation between bone and soft tissue infectious. The sensibility is reported to be nearly 100% with a specificity of more than 75%.

However, MRI is expensive and not rapidly accessible.

Therefore, ultrasonography, a non invasive, painless, inexpensive, and non radiating exam can be used to assess the presence and extent of inflammation, destruction, and tissue response.

The objective is to describe, using ultrasonography, the abnormalities joint structure influenced the septic arthritis evolution and prognosis.

The investigators hope, at the end of this study, to evaluate ultrasonography interest in septic arthritis and to establish ultrasonography prognosis factors to predict treatment efficiency and functional outcome.


Eligibility Criteria:
Inclusion Criteria:

* Major patients hospitalized in Rheumatology, Infectiology, Orthopedy Department (hospital of Nantes, of La Roche sur Yon and of Saint-Nazaire) with a septic arthritis of shoulder, or elbow, or wrist , or hip, or knee, or ankle on native joint, with positive microbiologic culture joint fluid or positive hemoculture; the diagnosis was based on positive histology or imagery with an inflammatory joint fluid if the microbiologic cultures (hemoculture or joint effusion) were negative.

Exclusion Criteria:

* Presence of material on the targeted joint
* Age \< 18 years old
* Patients under guardianship
* Pregnancy
Additional 4 Cycles of Cisplatin (CDDP4) in Patients With Triple Negative Breast Cancer for Neoadjuvant Chemotherapy

Achievement of pathologic complete response is important prognosticator to predict long term outcome in triple negative cancer. The efficacy of adding 4 cycles of cisplatin (CDDP4) is to be investigated whether addtional pathologic complete response is achieved for those triple negative breast cancer patients who recieved 4 cycles of adriamycin with cyclophosphamide(AC4) but did not reach clinical complete response during the course of neoadjuvant therapy.

First outcome measures (analysis) :at the time of surgery,

Second outcome measures:

2019 August, 5 year Overall Survival, Disease free survival

Eligibility Criteria:
Inclusion Criteria:

1. Patients with histologically proven breast cancer
2. Age, at least 20 years
3. ER/PR/HER2 (negative/negative/negative

   * ER/PR negative: nuclear reaction \< 1%, Allred score 0 or 2
   * HER2 negative: HER2; IHC (immunohistochemistry) 0,1+ or FISH/SISH (-) in case of IHC 2+
4. Clinically stage II or III with histologically proven lymph-node involvement (T \>1.5 cm or lymph node \[LN\] \>1.5 cm)
5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
6. No prior hormonal treatment, chemotherapy or radiotherapy is allowed.
7. Adequate hematologic, liver and kidney function
8. Written informed consent

Exclusion Criteria:

1. Pregnancy or lactation
2. Prior chemotherapy or radiotherapy for any malignancy
3. Stage T4d; inflammatory breast cancer
4. No primary tumor (T0)
5. Documented history of cardiac disease contraindicating anthracyclines
6. Currently active infection
Platelet Rich Plasma Versus Corticosteroids in Knee Osteoarthritis Pain

Prospective, multi-center, randomized trial comparing platelet rich plasma (PRP) versus corticosteroid injection for the treatment of symptoms of knee osteoarthritis. The purpose of the study is to determine which therapy provides a greater reduction in patient reported outcome measures of pain and function.

Platelet rich plasma has become increasingly utilized as a treatment option for knee osteoarthritis. Corticosteroids is currently an approved medication to treat the symptoms of the knee osteoarthritis. There is limited evidence in a prospective randomized manner powered adequately to determine a difference between these treatments for pain associated with knee osteoarthritis.

Prospective, multi-center, single blind (participant), randomized trial comparing platelet rich plasma (PRP) versus corticosteroid injection for the treatment of symptoms of knee osteoarthritis. The purpose of the study is to determine which therapy provides a greater reduction in patient reported outcome measures of pain and function.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, aged 21-80 years
* Radiographic diagnosis of Kellgren-Lawrence (KL) grade of II or III knee osteoarthritis
* Indicated for a knee injection to treat knee OA symptoms

Exclusion Criteria:

* Any injections into the target knee within three months
* Current overlying skin infection
* Current or previous diagnosis of "chronic pain"
* Opioid tolerant at time of screening (for a week or longer, at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid.)
* Allergy to any potential ingredients or medications utilized in any of the two groups
* Treatment with another investigational drug or other intervention for pain
* Diagnosis of Diabetes Mellitus
* If female, pregnant or planning to be pregnant within the following 3 months or study duration
* Any condition(s) or diagnosis, both physical or psychological, or physical exam finding in the opinion of the investigator that would precludes participation
Oxygen Concentration and Recovery After Carotid Endarterectomy

This study evaluates effects of high inspiratory oxygen on cerebral tissue oxygenation and patient recovery after carotid endarterectomy. Two group of patient undergoing to carotid with total intravenous anaesthesia will receive either 35% inspired oxygen or 100% oxygen.

High inspired oxygen concentration may reduce brain hypoxia in the patients undergoing carotid endarterectomy with total intravenous anaesthesia. However, there are some studies suggesting that high inspired oxygen concentration may induce cerebral vasoconstriction. This study was performed to measure the influence of fraction of inspired oxygen (FiO2) on the regional tissue oxygenation in the patients undergoing carotid endarterectomy with total intravenous anaesthesia. The INVOS 5100B monitor was used for regional cerebral oxygen saturation (rSO2) measurement from operative and nonoperative side, and INVOS Analytics Tool (Covidien) for area under curve (AUC) calculations. A bispectral index and invasive blood pressure monitoring were used in all patients.

Eligibility Criteria:
Inclusion Criteria:

* patient undergoing surgery (carotid endarterectomy)

Exclusion Criteria:

* decompensated and uncontrolled respiratory and cardiac disease, myocardial infarction suffered in the last 6 months, cerebrovascular infarction, coagulopathy, anaphylaxis to drugs
Effects of Vaginal Oxytocin Gel on Vaginal Cytologic Parameters in Postmenopausal Woman

Vulvovaginal atrophy affects around 90% of postmenopausal women who may present with symptoms such as dryness, irritation, itching, burning, and dyspareunia that negatively affect the quality of life. Topical estrogen is recommended for the treatment of vulvovaginal atrophy in postmenopausal women and the FDA approved it. But it may increase the risk of breast and endometrial cancer. The oxytocin hormone also promotes positive social behavior, stress regulation, and female sexual arousal. Many previous studies show that topical oxytocin is useful for reducing vaginal atrophy in postmenopausal women.

Random and conducted on 56 postmenopausal women who meet the inclusion criteria and excluded participants that have exclusion criteria. All women provided written informed consent before data collection.

1. st Visit: The vagina was assessed regarding infection and any abnormal discharge. The participants were evaluated vaginal signs of vaginal atrophy by per vaginal examination and assessed vaginal health index score. The subjective symptoms were assessed by The most bothersome score. The vaginal pH was tested with a Nitrazine paper. The vaginal swab was done and the specimen was sent for a cytological test - vaginal maturation index evaluation (VMI). The participants were separated into two groups 1. Oxytocin gel group and 2. Placebo gel group then applied gel 1 ml. (400IU of oxytocin in oxytocin gel) per day for 8 weeks consecutively. The subjective symptoms were assessed at 2 and 4 weeks by phone.
2. nd Visit: The participants were assessed the same as 1st visit that recorded vaginal health index score, subjective symptoms, vaginal pH, and vaginal maturation index evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Thai menopausal women aged between 50-70 years who visit Rajavithi gynecology OPD with informed consent with good communication in the Thai language.

Exclusion Criteria:

* Have acute vulvovaginitis (vaginal swab for wet smear and KOH)
* Patients who have used hormonal replacement therapy within 12 months
* Patients with a history of smoking
* Patients who have used vaginal lubricant or moisturizer
* Patients with an allergic history of oxytocin or gel components
* Morbid obesity BMI \> 30 kg/m2
* Patients who have used vitamin E supplement
* Patients who unable to perform per vaginal examination