cyrilzakka/clinical-trials huggingface dataset:
Long Term Results of Randomized Prospective Comparison of Onlay and Sublay Mesh Repair Techniques for Incisional Hernia

Randomised prospective comparison of onlay and sublay mesh repair techniques in incisional hernia


Eligibility Criteria:
Inclusion Criteria:

* Incisional hernia
* Acceptance of the trial

Exclusion Criteria:

* BMI\>40
* ASA score of 4
* Severe pulmonary or cardiac disease
Clinical Efficacy of OneTouch® Verio™IQ Meter

Diabetes mellitus is one of the most prevalent disease in the western world. The control of glucose levels has a big impact in the prevention of diabetes complications. The measure of glucose levels in capillary blood with glucometers is the gold standard to measure and control the glucose levels. Nowadays the glucometers become to more precise and sophisticated devices. One of the most notables advance is the inclusion of software that cam predicts glucose trends. This software has not be tested in routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed with diabetes mellitus 1 or 2
* Treatment with insulin regimen during at least 12 months
* Capability of performed 3 glucose measurement per day
* Levels of glycated hemoglobin (A1C) less than 10%

Exclusion Criteria:

* Patients diagnosed of mental disorders
* Patients included in structured therapeutic health 6 months before the inclusion
* Patients included in any clinical trial in the 4 months before the inclusion
Ultrasonographic Evaluation of the Diaphragm During NHF Versus NIV Use in Respiratory Failure

This study will describe influence of NHF or NIV to different ultrasonographic parameters of the diaphragm. Therefor subjects will be randomized to the sequence NHF and than NIV or NIV and than NHF. In all subjects same parameters will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* acute or chronic respiratory failure, hyperemic or hypercapnic
* age \> 18 yrs
* written consent

Exclusion Criteria:

* critical disease (intubation, heart failure, lung edema,..)
* no compliance
* metabolic acidosis
Central Corneal Thickness and 24-hour Fluctuation of Intraocular Pressure

The purpose of this study is to determine whether 24-hour fluctuation of intraocular pressure (IOP) is associated with central corneal thickness (CCT) in subjects with ocular hypertension or open angle glaucoma and in age-matched controls. Also to evaluate whether mean IOP reduction as a response to latanoprost (0.005% Xalatan) is associated with CCT, after a 4-weeks period of treatment.

Also, to evaluate whether 24-hour fluctuation of IOP is associated with corneal hysteresis (CH) measured by Ocular Response Analyzer (ORA).


Eligibility Criteria:
Inclusion Criteria:

Males and females \>50 years old with:

* Primary Open-Angle Glaucoma newly diagnosed or with anti-glaucoma medical treatment \< =12 weeks
* Pseudoexfoliative Glaucoma newly diagnosed or with anti-glaucoma medical treatment \<= 12 weeks
* Ocular Hypertensives newly diagnosed or with anti-glaucoma medical treatment \<= 12 weeks
* Age-matched controls
* IOP\>=22mmHg at the eligibility visit for glaucoma patients and ocular hypertensives

Exclusion Criteria:

For Eye

* Use of any ophthalmic medication (drops) during the study (except for natural tears)
* Inflammation of any aetiology
* Previous eye surgery or laser
* Corneal abnormalities (oedema, dystrophies etc) For Subjects
* Systemic diseases which affect the cornea (such as autoimmune diseases)
* Inability to participate due to advanced age or serious illness
* Mean IOP\>36mmHg in either eye at the eligibility visit.
* Subjects who cannot safety discontinue use of all IOP-lowering medication(s) for washout
* Subjects with severe central visual field loss in either eye. Severe central visual field loss is defined as sensitivity \<=10dB in at least 2 of the 4 visual field test points closest to the point of fixation
* Other types of glaucoma (such as angle-closure glaucoma and secondary glaucomas)
Hemostasis Using Surgicel in Pediatric Tonsillectomy

Tonsillectomy is one of the commonest procedures performed in otolaryngology and one of its major complications is post-tonsillectomy bleeding.

The goal of this study was to assess the effectiveness of Surgicel without bipolar cautery in achieving primary hemostasis in tonsillectomy. The patient that were enrolled in this retrospective study were patients who underwent tonsillectomy and achieved hemostasis either by Surgicel (group A) or bipolar cautery (group B). Our results showed that there was no statistical significant difference between the two techniques in terms of post-operative bleeding events.

Tonsillectomy is one of the commonest procedures performed in otolaryngology and one of its major complications is post-tonsillectomy bleeding.

The goal of this study was to assess the effectiveness of Surgicel without bipolar cautery in achieving primary hemostasis in tonsillectomy.

The study was a retrospective cohort in three tertiary care centers in xxxx, from January 2016 to August 2018. All patients underwent at least tonsillectomy, with a proportion undergoing additional adenoidectomy, myringotomy, or tube insertion as indicated, were enrolled in the study. Patients were stratified to 2 groups according to the surgeons preference for the hemostasis technique, one was subjected to cold dissection tonsillectomy and achieved hemostasis via the application of Surgicel to the surgical site, and the other underwent cold dissection tonsillectomy and attained hemostasis through bipolar cautery.

Eligibility Criteria:
Inclusion Criteria:

* Patients under age of 12, diagnosed with recurrent tonsillitis or OSA and are candidates for tonsillectomy
* patients must have went tonsillectomy

Exclusion Criteria:

* age more than 12
Effect of Frankincense Extract Gel on Non-Surgical Treatment of Chronic Periodontitis

This study will evaluate the effect of the subgingival application of Frankincense extract gel as an adjunct to scaling and root planning (SRP) in chronic periodontitis.

: twenty patients will be randomly selected and equally divided into Group I: will receive SRP only, group II: will receive SRP and Frankincense extract the gel. Subgingival application of Frankincense extract gel will be performed following initial SRP )day 1) and at 7, and 14 days. Clinical measurements included pocket depth (PD), bleeding on probing (BOP), and clinical attachment level (CAL). Real-time PCR was carried out to determine the effect of the treatment on Porphyromonas gingivalis (Pg). Clinical measurements and Plaque samples for PCR were recorded at baseline (before treatment), one, and three months after treatment.

Eligibility Criteria:
Inclusion Criteria:

* systemically healthy patients were selected
* patients who had not received any medications for the previous six months that may interfere with periodontal tissue health or healing.
* Patients should demonstrate their ability to maintain good oral hygiene

Exclusion Criteria:

* Smokers and pregnant patients.
* Medically compromised patients and systemic conditions precluding periodontal surgery.
A Safety and Effectiveness Study of SABER®-Bupivacaine for Pain Following Shoulder Surgery

This is a research study testing SABER-Bupivacaine (an experimental pain-relieving medication). SABER-Bupivacaine is designed to continuously deliver bupivacaine, a common local anesthetic, for a few days in order to treat local post-surgical pain.

The purpose of this study is to investigate safety (if there are any side effects) associated with the use of SABER-Bupivacaine and how well it works in reducing pain and opioid-related side effects following shoulder surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be able to read and understand the consent form, provide written consent, complete trial-related procedures, and communicate with the trial staff.
* Males and females, 18 to 65 years of age, scheduled for shoulder surgery.
* Patients must be healthy or have only mild systemic disease.
* Patients must have ECG wave form within normal limits
* Patients must have blood pressure within normal range.
* Male and female patients must agree to use medically acceptable method of contraception throughout the entire trial period and for 1 week after the trial is completed.
* Patients must refrain from strenuous activities and avoid changes to prescribed exercise levels throughout the course of the trial.

Exclusion Criteria:

* Patients with previous arthroscopic surgery or open surgery on the study shoulder.
* Patients with chronic pain conditions requiring continuous use of corticosteroids for greater than 3 months.
* Patients with fibromyalgia, rheumatoid arthritis, and/or sero-negative inflammatory arthropathies.
* Patients with a below normal calculated creatinine clearance.
* Patients who are pregnant or lactating.
* Patients currently receiving more than 20 mg of hydrocodone daily (or equivalent narcotic dose) on routine basis.
* Patients, who in the Investigator's opinion, have developed opioid tolerance.
* Patients with current or regular use of anticonvulsants, antiepileptics, antidepressants, or monoamine oxidase inhibitors at screening.
* Patients with current or regular use of drugs known to significantly prolong the corrected QT interval
* Patients with known hypersensitivity to local anesthetic agents of the amide type (e.g., lidocaine, bupivacaine).
* Patients with known hypersensitivity to opioids.
* Patients with conditions contraindicated for use of opioids.
* Patients with known or suspected abuse of opioids or other illicit drugs.
* Patients with known or suspected alcohol abuse.
* Participation in another clinical trial at the same time or within 30 days of this trial.
* Patients who, in the Investigator's opinion, should not participate in the trial or may not be capable of following the trial schedule for any reason.
Safety, Tolerability and Pharmacokinetics of 14-day Multiple Dose Titrations of TS-134 in Healthy Volunteers

This is a Phase 1 study involving multiple dose titrations of TS-134 in healthy male and female subjects. The safety, tolerability and pharmacokinetics of multiple dose titrations of TS-134 will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult male and female participants between 18 and 55 years of age
* Body weight greater than or equal to 45 kg
* Body Mass Index (BMI) greater than or equal to 18 and less than or equal to 30 kg/m\^2

Exclusion Criteria:

* Female participants who are pregnant, intend to become pregnant, or are breastfeeding
* Clinically significant abnormal physical examination, 12-lead electrocardiogram (ECG) OR cardiac telemetry prior to dosing.
* Significant history or presence of hepatic, renal, cardiovascular, pulmonary, gastrointestinal, hematological, locomotor, immunologic, ophthalmologic, metabolic or oncological disease.
* History or presence of psychiatric or neurologic disease or condition
* History of alcohol or drug abuse
* Any participant who currently uses or has used tobacco or tobacco-containing products for at least one month prior to screening
* Participated in strenuous exercise within 48 hours prior to study start (initial dosing) and/or are unwilling to avoid strenuous exercise at any time throughout the study.
Angiogenic Factor Expression During Fractionated Irradiation

The main question of this study is if and when VEGF (vascular endothelial growth factor) expression in the tumor is upregulated during chemoradiation and if bevacizumab inhibits subsequent vessel growth in the tumor.

* Therefore the first aim of this study is to identify the time point of induction of VEGF in the tumor tissue of esophagus carcinoma during chemoradiation (after 1,2,3 or 4 weeks of chemoradiation).
* If we identify increased expression of VEGF at a certain time point, our second aim is to determine if we can inhibit the subsequent tumor vessel growth by administration of bevacizumab.


Eligibility Criteria:
Inclusion Criteria:

* patients that will receive chemoradiation following CROSS-schedule before surgery for esophageal carcinoma
* ability to give informed consent
* age 18 years or older

Exclusion Criteria:

* pregnancy
* evidence of bleeding diathesis, coagulopathy
* inflammation of the GI-tract
* brain metastases
* diastolic/ systolic hypertension, not responding to treatment
* arterial thromboembolism in medical history
* surgery within the month prior to start of bevacizumab treatment
Improving Surgical Communication for Patients in Wisconsin

The purpose of this study is to evaluate a new training program to support communication between surgeons and their patients. The goal of the training program is to help patients get the information they need to make treatment decisions that are right for them.

Participants will complete surveys, attend a focus group, or receive training on Better Conversations, depending on the type of participant.

Observational research shows that surgeons translate informed consent and shared decision-making standards into an overly complicated technical explanation of the patient's disease and treatment, and an overly simplified narrative that surgery will "fix" the patient's problem. They omit critical information about the goals and downsides of surgery and struggle to actualize the patient's role in medical decisions, while unintentionally concealing professional expertise. "Better Conversations" is a novel communication framework designed to address these problems. With this framework, surgeons provide context about clinical norms, clearly establish the goals of surgery, and comprehensively delineate the downsides of surgery as experienced by the patient to generate a deliberative space for patients to consider whether surgery is right for them. This paradigm-shifting framework meets the legal and ethical standards for informed consent, supports deliberation, and allows patients to anticipate and prepare for the experience of surgery.

The present study supports optimization of surgeon training and study procedures (Phase II) that is needed before large scale testing and dissemination (Phase III). Although this intervention is evidence based, collaborative efforts are needed to ultimately test and disseminate a major clinical shift. The long-term goal is for every surgeon to use Better Conversations with every patient, every time. The present study has two main objectives: 1) To make the education program scalable with automated assessment and feedback to surgeons using audio recordings from their clinical conversations, and 2) to evaluate patient and family reported outcome measures regarding surgeon communication.

Eligibility Criteria:
Inclusion Criteria:

Surgeons:

* Surgeons from University of Wisconsin - Madison Department of Surgery who have an outpatient surgical clinic and treat adult patients at UW Health

Surgical candidates:

* Age 18 or older
* Present to an enrolled surgeon's clinic with a surgical problem
* Decision making ability
* Speak English

Stakeholders:

* Must have previous experience with surgery (within 10 years)
* Speak English

Exclusion Criteria:

Surgeons:

* Solely treat minors (under age 18)

Surgical candidates:

* Lacking decision making capacity
* Unable to speak English

Stakeholders:

* Unable to speak English
Efficacy Study of Neoadjuvant Chemotherapy With Chemoradiation Therapy for Nasopharyngeal Carcinoma

Locally advanced nasopharyngeal carcinoma patients(UICC7th stageIII to IVb) will receive either cisplatin plus 5-fluorouracil (PF) or docetaxel plus cisplatin and 5-fluorouracil(TPF) neoadjuvant chemotherapy with concurrent chemoradiation.

For locally advanced nasopharyngeal carcinoma patients(UICC7th stageIII to IVb),the investigators randomised assign to either 3 cycles of cisplatin plus 5-fluorouracil plus (PF) or 3 cycles of docetaxel plus cisplatin and 5-fluorouracil(TPF) neoadjuvant chemotherapy. 21 days a cycle.

After the neoadjuvant chemotherapy ,the patients will receive the intensity modulated radiotherapy(IMRT) with 2 cycles of concurrent chemotherapy of cisplatin 80mg/m2.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with newly histologically confirmed non-keratinizing carcinoma.
2. Tumor staged as N2-3 or T3-4N1(according to the 7th AJCC staging system)
3. No evidence of distant metastasis(M0)
4. Performance status:KPS\>70
5. With normal liver function test(ALT, AST\<1.5ULN)
6. Renal:creatinine clearance \>60ml/min
7. Without hematopathy,marrow:WBC\>4\*109/L, HGB\>80G/L, and PLT\>100\*109/L.
8. With controled blood glucose for diabetes patients
9. Written informed consent

Exclusion Criteria:

1. WHO type I squamous cell carcinoma or adenocarcinoma
2. Age\>70 or \<18
3. With a history of renal disease
4. Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin0
5. Previous chemotherapy or radiotherapy(except non-melanomatous skin cancers outside the intended RT treatment volume)
6. Patient is pregnant or lactating .
7. Peripheral neuropathy
8. Emotional disturbance
Influenza Virus Challenge Study to Test Monoclonal Antibody TCN-032 as a Treatment for Influenza

The purpose of this study is to determine the safety and efficacy of TCN-032 given to healthy adult volunteers that have been inoculated with the influenza A virus


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 45 years, inclusive.
* In good health with no history of major medical conditions
* Female subjects must not be pregnant or nursing
* Have not been vaccinated for influenza virus since 2006
* Serosusceptible to the challenge virus
* Non-smoker or current smoker willing/able to desist

Exclusion Criteria:

* Presence of any significant acute or chronic, uncontrolled medical or psychiatric illness
* History or evidence of autoimmune disease
* Any history during adulthood of asthma, history of COPD, pulmonary hypertension, reactive airway disease, any chronic lung condition of any etiology), or any use of a bronchodilator or other asthma medication within adulthood
* History or clinical evidence of recurrent lower respiratory tract infection
* Positive human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV) antibody screen
* Subject is diabetic
* History of frequent epistaxis (nose bleeds)
* Any nasal or sinus surgery within 6 months of the screening visit
* Recent and/or recurrent history of autonomic dysfunction (fainting, palpitations, etc.)
* Any laboratory test, ECG or spirometry which is abnormal and which is deemed by the Investigator(s) to be clinically significant.
* Any acute medical condition or significant past medical history of hepatic, renal, cardiovascular, pulmonary, gastrointestinal, haematological, locomotor, immunologic, ophthalmologic, metabolic, endocrine, or other diseases
* Major surgery within 3 months prior to screening visit
* Evidence of drug of abuse or positive urine Class A drug or alcohol screen prior to admission
* Subjects symptomatic with hay fever
* Subjects with a history of significant adverse reactions/allergies
* History of allergy or intolerance to oseltamivir or zanamivir.
* Health care workers (including doctors, nurses, medical students, and allied healthcare professionals) anticipated to have patient contact within 2 weeks of viral challenge.
Application of Serial Body Composition Change for Risk Prediction in Treating Patients With Severe Pneumonia

We hypothesize that serial changes of body composition in patients with pneumonia can help clinician to monitor prognosis. It was associated with underlying immune response.

Specific aims:

1. Can serial body composition data be useful for predicting outcomes of patients with pneumonia? (developing sepsis, organ failure, admission to ICU, length of ICU, survival, length of stay in hospital, prolonged mechanical ventilation,..)
2. Can serial body composition data be integrated into both immune status alternatives (e.g., white blood cell (WBC) count, segment/monocyte ratio, pulse pressure) in such critical illness and monitoring responses (SOFA score, labs) for severe pneumonia patients?
3. Can serial body composition data reflect clinical variables in patients with pneumonia, and even altered by nutrition intake? (e.g., compare association between nutrition intake amount and groups stratified by body composition, blood pressure, nutritional intake, ...)

Eligibility Criteria:
Inclusion Criteria:

Adult patients with pneumonia admitted to the thoracic ward or medical intensive care unit of Kaohsiung Chang Gung Memorial Hospital

Exclusion Criteria:

-
Mobile Phone Technology to Increase Genetic Counseling

This innovative project seeks to harness mobile phone technology as a means to take preventive health care to a new level among ovarian cancer survivors. Using the Fogg Behavioral Model, developed from the concept of persuasive technology, this study proposes to develop the Mobile Application for Genetic Information on Cancer (mAGIC) intervention to motivate ovarian cancer survivors to undergo genetic counseling. The overall study objective is to develop and assess the feasibility and effectiveness of a theory-based intervention aimed to encourage ovarian cancer survivors to receive genetic counseling

This project seeks to harness mobile phone technology as a means to take preventive health care to a new level among ovarian cancer survivors. Using the Fogg Behavioral Model31 (FBM), developed from the concept of persuasive technology, this study proposes to develop the Mobile Application for Genetic Information on Cancer (mAGIC) week-long intervention to motivate ovarian cancer survivors to undergo genetic counseling.

Eligibility Criteria:
Inclusion Criteria:

* Woman diagnosed with ovarian, primary peritoneal or fallopian tube cancer
* 18 years old or older
* At least a fifth grade education
* Able to read and write in English
* Voluntary written informed consent before study entry, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.

Exclusion Criteria:

• Known major psychiatric or neurological diagnosis
Clinical Outcome of Patients With Low-gradient Severe Aortic Stenosis

To assess the ability of baseline clinical parameters and imaging modalities to predict short and long term left ventricular function and clinical outcome of subjects with low-gradient, severe aortic stenosis.

To assess the impact of aortic valve replacement as compared to medical therapy on clinical outcome of patients with low-gradient, severe aortic stenosis.

To assess possible impact of aortic annulus assessment using 3-dimensional imaging modalities on the assessment of AS severity and definition of low gradient severe aortic stenosis.

To assess the ability of baseline clinical parameters and imaging modalities to predict short and long term left ventricular function and clinical outcome of subjects with impaired left ventricular function and / or low-gradient, severe aortic stenosis.

To assess the impact of aortic valve replacement as compared to medical therapy on clinical outcome of patients with impaired left ventricular function and / or low-gradient, severe aortic stenosis.

To assess possible impact of aortic annulus assessment using 3-dimensional imaging modalities on the assessment of AS severity and definition of low gradient severe aortic stenosis.

Eligibility Criteria:
Inclusion Criteria:

1. Severe aortic stenosis defined as aortic valve area of less than 1 cm2 or index area of 0.6 cm2/m2 and low gradient (mean gradient across the aortic valve \<40 mmHg) by echocardiography
2. Symptomatic patients with aortic stenosis referred for medically indicated AVR
3. Signed informed consent to participate in the study.

Exclusion Criteria:

1. Pregnancy or breast feeding (women of childbearing potential will have a serum or urine pregnancy test).
2. Need for emergency surgery for any reason.
3. Any case in which the practicing physician asserts that enrollment in the protocol will adversely affect the patient treatment course.