cyrilzakka/clinical-trials huggingface dataset:
Clinical Evaluation of OSNA Breast Cancer System to Extensive Frozen Section Histopathology

The study will determine the sensitivity, specificity, negative predictive value and positive predictive value of the OSNA Breast Cancer System by comparing its performance to an extensive intraoperative frozen section protocol for Sentinel Lymph Nodes removed during standard Sentinel Lymph Node biopsy procedures from breast cancer subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male or female;
* 18 years of age or older;
* Diagnosed pre-surgically with T1 or T2 breast cancer without clinical evidence of axillary lymph node involvement and scheduled for surgery including sentinel lymph node dissection;
* Subjects (or the subjects' legal representatives) who have read, understood to the best of their ability and signed the informed consent form.

Exclusion Criteria:

* Subjects diagnosed pre-surgically with large or locally advanced (T3 \& T4) breast cancer;
* Pregnant subjects, confirmed by interview with either subject or treating physician;
* Subjects diagnosed with inflammatory breast cancer;
* Subjects diagnosed with ductal carcinoma in situ (DCIS) when breast conservation is to be done;
* Subjects with clinically suspicious, palpable axillary lymph nodes;
* Subjects previously treated for or previously diagnosed with another type of invasive cancer. Subjects with skin cancer (basal cell and squamous cell carcinoma) may be included, except for subjects diagnosed with melanoma; Subjects with non-invasive carcinoma of the Cervix may also be included in this study.
* Subjects who have received pre-operative systemic therapy;
* Subjects who are incapable of providing written informed consent;
* Subjects who have been judged to be an inappropriate candidate by any medical care provider (e.g., surgeon, oncologist or pathologist).
* Subjects participating in other clinical studies where the SLN evaluation will be negatively impacted by this study.
Bypassing Anesthesiologist Assessment Before Cataract Surgery: a Non Inferiority Study

This study aims to demonstrate that presurgical assessement of patients' risk factors and surveillance during surgery, both performed by nurses, are not inferior to anesthetic team's care, concerning the rate of complications in cataract surgery with topical anesthesia.

The nurse performs the triage of patients based on a chart of risk factors assessment. The triage, according to the presence or not of risk factors, leads to patients' care by an anesthetic team (medical anesthesist for pre-surgical assessement and anesthetic nurse for surveillance during surgery) or to patients' pre-surgical assessement and surveillance during surgery both performed only by nurses.

In the control group, all patients are taken care of by an aesthetic team, with medical pre surgical assessement and surveillance during surgery both performed by anesthetic nurses.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years old
* cataract surgery scheduled with topical anesthetics
* outpatient surgery

Exclusion Criteria:

* presurgical nurse assessment leading to the need for the anesthetic staff presence during surgery
* general, peribulbar or other locoregional anesthesia required by patient's condition
* concomitant surgery planified (glaucoma, vitrectomy...)
* patient's refusal to participate in the study
* no health insurance coverage
Effect of Fluticasone Furoate on Methacholine Challenge

The study will determine the effect of inhaled fluticasone furoate on airway responsiveness to methacholine in mild asthmatics.


Eligibility Criteria:
Inclusion Criteria:

* forced expiratory volume in one second (FEV1) greater than or equal to 65% predicted
* methacholine PD20 less than or equal to 400mcg
* no allergen exposure (if atopic) or respiratory infection for at least 4 weeks prior to study start

Exclusion Criteria:

* regular use of inhaled corticosteroid within 4 weeks of study start
* poorly controlled asthma
* current smoker or ex smoker with greater than 10 pack year history
* pregnancy or breast-feeding
* health concern/condition that would preclude participation for safety reasons
Injection of Cyanoacrylate+Lipiodol vs Cyanoacrylate+Lauromacrogol in Gastric Varices

The purpose of this randomized study to compare effect of endoscopic injection of a mixture of cyanoacrylate and lipiodol versus cyanoacrylate and lauromacrogol in gastric varices.

Gastroesophageal variceal bleeding is known as one of the most frequent death causes of patients with portal hypertension. When a patient has a bleeding episode, if no further prophylactic treatments is given, it's very likely that he/she will develop another rebleeding event in the future and maybe a terminal event. Gastric varices occur in 18-70% of patients with portal hypertension, which appear to be more severe, to require more transfusion and to have a higher mortality rate than esophageal variceal bleeding, with a high rate of rebleeding(38-89%). It has been recommended to use endoscopic cyanoacrylate injection as the first line treatment for hemostasis and secondary prophylaxis for gastric varices by general consensus. However, the efficacy and prevalence of complications between mixture of cyanoacrylate + lipiodol and cyanoacrylate + lauromacrogol have not yet been explored and reported. We conducted this study to evaluate the effect of endoscopic injection of a mixture of cyanoacrylate and lipiodol versus cyanoacrylate and lauromacrogol in gastric varices.

Eligibility Criteria:
Inclusion Criteria:

* Patients presented to our hospital with acute gastric variceal bleeding, with or without liver cirrhosis.
* The age of the patients range from 18 to 80 years old.

Exclusion Criteria:

* Patients who have contraindications for cyanoacrylate, lipiodol or lauromacrogol therapy.
* Patients who have abnormal portosystemic shunt according to the imaging results.
* Patients who have no previous upper gastrointestinal bleeding history.
* Patients who have multiple endoscopic treatments for esophagogastric varices before.
Telephone Support for Dementia Caregivers

Caring for a patient with dementia is associated with increased feelings of burden and depression. The proposed study will examine the efficacy of Family Intervention: Telephone Tracking - Dementia (FITT-Dementia), a multi-component, family-based, telephone intervention, as a tool to reduce caregiver stress.

A previous pilot study of this approach showed reduced burden and reaction to memory and behavior problems for dementia caregivers. This study will test the intervention in a larger group of caregivers and have a more detailed analysis of outcomes.

The caregiver of a person with dementia will receive telephone support calls. They will receive telephone calls from a trained member of the research team. These calls will occur over a six-month period and will be scheduled at a time that is convenient for the caregiver. They will receive a total of 16 calls over 6 months. During each call, the support person will discuss their current caregiving situation and provide various forms of support.

Eligibility Criteria:
Inclusion Criteria:

* 1) Diagnosis of dementia;
* 2) mild to moderate dementia;
* 3) family member or other adult in caregiver role for at least 6 months, and who provides at least 4 hours of supervision or direct assistance per day for the person with dementia;
* 4) care recipient lives in the community, including senior/retirement centers, but excluding nursing homes and assisted living centers; and
* 5) there is no plan for the care recipient to be placed in long term care or the caregiver to end their role within the next 6 months

Exclusion Criteria:

Patient:

* 1) other major medical condition affecting independent functioning
* 2) older than age 90; and
* 3) younger than age 50.

Caregiver:

* 1) major acute medical illness;
* 2) English not primary language;
* 3) cognitive impairment;
* 4) no access to a telephone; or
* 5) older than age 90.
Evaluation of Maraviroc Intensification in HIV Infected Patients With Insufficient Immune Restoration

This pilot study aims to evaluate Maraviroc intensification strategy during 24 weeks in HIV infected patients under efficient (CV\< 50 cp/mL), controlled antiretroviral therapy (≥ 6 months) and uncompleted immune restoration (CD4\<350 cells/mL and CD4 earning \<100 cells/mL during last 24 months).

The study will include 60 patients whose follow up is carried out for 48 weeks. recruitment period will be maintained for 12 months.


Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infection
* maraviroc-naives patients
* CD4 less than 350 cells/mm3
* viral load less than 50 cp/mL and CD4 earning less than 100 cells/mm3 during last 24 months

Exclusion Criteria:

* HIV-2 infection
* X4 tropism at inclusion
* pregnancy and breast feeding
* interferon, immunomodulatory drugs treatment or anti-HIV vaccines and chemotherapy
* hypersensibility of peanut or soya
Fibrinogen Concentrate and Placenta Acreta Spectrum

The aim of this study is to evaluate the relationship between fibrinogen use and bleeding in patients who underwent cesarean section with a prediagnosis of PAS.

The key question(s) it aims to answer are:

\[Does the use of fibrinogen concentrate reduce bleeding in PAS patients?\] Patients who had a cesarean section with a pre-diagnosis of PAS were analyzed retrospectively. The choice of anesthesia applied to the patients and the relationship between the use of blood products and bleeding were evaluated.

Our study was designed as a retrospective randomized study. Patients aged 20-50 years and \>34 weeks of gestation who accepted the birth with a cesarean section with a pre-diagnosis of PAS were evaluated retrospectively.

examined. were randomized into 2 groups, 53 patients in each group: group1: GNF : the group without fibrinogen concentrate

Group 2: GF: the group with fibrinogen concentrate

Eligibility Criteria:
Inclusion Criteria:

* 20-50 years PAS pre-diagnosed pregnant women
* \>34 weeks of pregnancy
* Those with normal renal functions

Exclusion Criteria:

* Patients with renal insufficiency
* Those with \<34 weeks of gestation
* Pregnant women with missing data
Comparison of Tapered- vs. Cylindrical-shaped Tube Cuffs Pressure Alteration With Nitrous Oxide

When using nitrous oxide for general anesthesia, nitrous oxide diffusion induces intracuff hyperinflation of the endotracheal tube. Furthermore the difference among various types of cuffed endotracheal tubes in cuff pressure behavior during nitrous oxide exposure.

TaperGuard(TM) tube has been newly introduced and has tapered-shape cuff. In vitro study, the intracuff pressure of TaperGuard(TM) tube was lower than that of conventional tube with cylindrical-shaped cuff of the conventional tube(Hi-Lo(TM) tube). Therefore, this clinical study is needed to evaluate the intracuff pressure during general anesthesia with nitrous oxide exposure.

During 60 minutes after routine anesthetic induction and intubation of the endotracheal tubes, intracuff pressures will be measured every 10 minutes with a manometer (VBM, Sulz, Germany).

60% nitrous oxide will be added at time 0. For 60 minutes from the beginning of general anesthesia, intracuff pressures will be measured every 10 minutes.

After 60 minutes, Intracuff pressures will be maintained around 20 cm H2O during the remaining period of the surgery.

The questionnaire for a sore throat, hoarseness, and dysphagia will be questioned at about 1, 6, and 24 hours after the surgery and the general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Patients who will undergo general anesthesia in a supine position with a neutral position of the head (hand and forearm sugery)
* 18\~70 years old
* American society of anesthesiologists physical status 1-2
* Body mass index \< 30 kg/m2

Exclusion Criteria:

* Contraindication for nitrous oxide
* Difficult intubation
* Cormack-Lehane grade \> 3
* Airway-related or pulmonary diseases
* Short or long operation time (\< 1 hour or \> 3 hours)
Periodontitis as Signal for an Underlying Disease

This study investigates the differences between subjects with and without periodontitis in: the prevalence of (pre)diabetes mellitus, the risk of atherosclerotic cardiovascular disease, the prevalence of metabolic syndrome and the risk of obstructive sleep apnea syndrome.

Diabetes Mellitus (DM), Atherosclerotic Cardiovascular Disease (ASCVD), Metabolic Syndrome (MetS) and Obstructive Sleep Apnea Syndrome (OSAS) are major health problems. However due to absence of symptoms and/or lack of knowledge, people are often unaware of having DM, ASCVD, MetS or OSAS while early treatment could prevent or stop the progression of these diseases. Therefore risk indicators for early detection of DM, ASCVD, MetS and OSAS are needed and proposed.

Many studies demonstrate the association between oral diseases and DM and/or ASCVD. The most observed chronic oral disease is periodontitis. Periodontitis is a common chronic multifactorial inflammatory disease of the supporting structures of the teeth. DM and ASCVD might, due to their proinflammatory state and alteration of the immune system, contribute to the onset and/or progression of periodontitis. Therefore periodontitis could be considered as an early sign of an underlying vascular and/or metabolic pathology.

Some studies have also reported a positive association between periodontitis and MetS. The MetS prevalence in patients with periodontitis was shown to be higher than controls and MetS showed to be associated with severe periodontitis. The association between periodontitis and OSAS is less established, however there is some evidence to a plausible association between periodontal disease and Obstructive Sleep Apnea (OSA).

Due to the broad overlap of objective biomarkers, in this study, subjects with or without periodontitis will be screened for determining the prevalence of (pre)DM, the 10 year risk of ASCVD, the prevalence of MetS and the risk of OSAS.

The screening will be based on clinical measures, specific blood markers determined by a developed finger stick procedure and three questionnaires.

Notably, a recently published pilot paper from the ACTA periodontology research group presents the feasibility and preliminary results of proposed screening for (pre)DM; 18.1% new DM cases were found among subjects with severe periodontitis, compared to 9.9% in mild/moderate periodontitis and 8.5% in controls.

Objective of the study:

The aim of the proposed study is to screen for (pre)DM, an increased 10 year risk of ASCVD, MetS and a high risk of OSAS in participants with and without periodontitis. Consequently, the dental office will be evaluated as a suitable location for early detection of these diseases.

Eligibility Criteria:
Inclusion Criteria:

* In order to be eligible to participate in this study, a subject must meet all of the following criteria:
* Age ≥ 40 years
* (Patient) referred for periodontitis
* (Control) visiting the dental school for regular dental check-up without periodontitis
* Able and willing to give written informed consent and comply with the requirements of the study protocol.

Exclusion Criteria:

* None
EXPAREL® for Pain After Tonsillectomy

The purpose of this study is to determine whether liposomal bupivacaine (long acting injectable anesthetic) provides greater post operative pain relief compared to the standard post operative pain regiment for tonsillectomy patients.

Subjects will be screened in the clinic when being evaluated for indications for tonsillectomy. Once the decision to proceed with tonsillectomy is made, the patient will be given the information on the study, provided time to review the information and interested patients will be consented.

There will be two stages in the study. The first will be the operative stage, which includes the injection during the operation. The second stage is the patient participation stage. During this stage, the patient records the amount of oral pain medication usage, oral intake after their procedure, in addition to their pain scores. These scores are recorded and brought back (or mailed in) to the clinic for collection during the follow up visit, approximately 1 month later (patients will keep records for two weeks). The patients will be freed from participation in the study after the one month visit.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of recurrent tonsillitis or bilateral tonsillar hypertrophy requiring bilateral tonsillectomy
* Willing and able to understand and provide written informed consent

Exclusion Criteria:

* Known pregnancy
* Women who are currently nursing a child
* History of coagulopathy; such as hemophilia or Von Willebrand disease, or any congenital or acquired bleeding disorder
* Use of anticoagulation medication during the study, i.e. aspirin, Coumadin, Plavix, or medications similar in class to these medications will exclude the patient from participation
* Inability to provide informed consent (patients under guardianship)
* Known hypersensitivity to local anesthetics
* History of cardiac disease; such as current impaired cardiovascular function, past history of myocardial infarction, congenital heart disease, current cardiac symptoms, i.e. angina, shortness of breath, or chest pain as determined by history or review of the medical record.
* History of complex pulmonary disease; such as uncontrolled asthma, chronic obstructive pulmonary disease (COPD), or interstitial lung disease as determined by history or review of the medical record.
* Impaired renal function as documented in the medical record in the last 3 months with a serum creatinine greater than 1.2 mg/dL or glomerular filtration rate \< 60 mL/min/body surface area (BSA) as determined by history or review of the medical record.
* History of or current hepatic disease as documented by liver function test abnormality in the last 3 months as determined by history or review of the medical record.
Study of Prevalence of Proteinuria, Urinary Tract Infection or Hematuria in Athletes

To understand the urine analysis of athletes

there maybe some genitourinary problem related to athletes, such as proteinuria, hematuria, scrotal pain, STD, etc. To explore these problems and give adequate management for them not only improved athletes' health, but also it can do their best in their exercise performance.

Eligibility Criteria:
Inclusion Criteria:

* proteinuria, hematuria, pyuria

Exclusion Criteria:

* bacteriuria
Major Depressive Disorder Study In Adults

A study to obtain safety and tolerability data


Eligibility Criteria:
Inclusion Criteria:

* Patient must have primary diagnosis of Major Depressive Disorder (MDD).
* Discontinued a selective serotonin reuptake inhibitor (SSRI)or serotonin-norepinephrine reuptake inhibitor (SNRI) regimen due to intolerability.
* Minimum time frame between last dose of previous antidepressant and initiation of study drug is one week.
* Maximum time frame between last dose of prior antidepressant and initiation of study drug is 2 months.

Exclusion Criteria:

* Patient has previously been treated with the study drug.
* Is experiencing an adverse event attributed to previous SSRI/SNRI use that has not been resolved at least one week prior to Baseline Visit.
* Has a history of seizure disorder.
* Has met criteria for substance abuse or dependence within 6 months prior to Baseline Visit.
* Currently using an antidepressant.
* Currently pregnant.
Ultrasound vs Palpation for Radial Artery Cannulation

The primary purpose of this study is to compare the palpation technique with ultrasound guidance for radial artery cannulation for bariatic surgery.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists 1, 2, 3 BMI ≥ 30 bariatic surgery

Exclusion Criteria:

* refusal infection or surgery history in wrist
To Assess the Safety of Avanafil in Healthy and Hepatically Impaired Male Subjects.

The objective of this study is to assess the single dose pharmacokinetics of avanafil in subjects with hepatic impairment and in healthy control subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects must be 21-75 years of age; inclusive. Healthy control subjects (Cohort 1) must be medically healthy with clinically insignificant screening results and hepatically impaired subjects (Cohorts 2 and 3) must have mild or moderate hepatic impairment based on the Child-Pugh Classification.

Exclusion Criteria:

* Main exclusion criteria for healthy control subjects (Cohort 1) include history or clinical evidence of clinically relevant cardiovascular (including thromboembolic disorders), hepatic, renal, hematologic, endocrine, pulmonary, gastrointestinal, psychiatric or neurological impairment; any clinically significant laboratory abnormalities as judged by the investigatorInvestigator; systolic blood pressure \< 90 or \>160 mmHg; diastolic blood pressure \< 50 or \> 90 mmHg; allergy to or previous adverse events with PDE5 inhibitors; use of prescription or over-the-counter drugs that are known to interfere with metabolism by the cytochrome P450 3A4 enzyme within 30 days of screening; use of any investigational drug within 30 days of screening; use of any prescription or over-the-counter drugs or herbal remedies within 14 days of screening; history of alcohol or drug abuse within 18 months, history of smoking within 6 months; positive breath alcohol test; positive serology for HIV, HCV, HBsAg; blood donation or significant blood loss within 56 days of dosing; plasma donation within 7 days of dosing.

Main exclusion criteria for hepatically impaired subjects (Cohorts 2 and 3) include any significant concurrent medical condition or history of significant medical conditions other than hepatic impairment that may affect the interpretation of the data or which otherwise contraindicates participation in this study; acute exacerbation of or unstable hepatic disease, as indicated by worsening of clinical and/or laboratory signs of hepatic impairment, within the 2 weeks preceding study drug administration; history of esophageal variceal bleeding within past 6 months; history of bleeding or non-bleeding gastric varices; history of spontaneous bacterial peritonitis within the past 3 months; history of portosystemic surgical shunt; autoimmune liver disease; history of organ transplant; Wilson's disease; diagnosis of cholestatic liver disease (e.g., primary biliary cirrhosis or primary sclerosing cholangitis); history of recent symptomatic cryoglobulinemia; alcoholic hepatitis, determined clinically or by histology; initiation of any new prescription or over the counter medications within 14 days before study drug administration and hemoglobin \< 9.0 g/dL, positive for AFP.