cyrilzakka/clinical-trials huggingface dataset:
SaCoVLM™ Video Laryngeal Mask Versus LMA Supreme

Our study aimed to compare two different laryngeal masks, SaCoVLM™ Video Laryngeal Mask and blind placement with LMA Supreme, in adult patients undergoing short elective surgeries. The aim is to optimize the use of commonly used laryngeal masks in clinical practice and examine the differences in oropharyngeal leak pressures.

Laryngeal masks are alternative airway devices commonly used in anesthesia, serving both spontaneously breathing and ventilated patients. LMA Supreme, a second-generation laryngeal mask, has been widely used in routine anesthesia practices and short-duration procedures in our clinic. The advantage of second-generation masks is the presence of gastric access pathways, allowing for additional decompression of the stomach. SaCoVLM™ Video Laryngeal Mask also features a gastric access pathway. Placement of laryngeal masks requires attention to the anatomical features of the airway. Unsuccessful placement of a laryngeal mask can lead to issues such as throat pain, hoarseness, difficulty swallowing, airway obstruction, or leakage, as well as an increase in intragastric pressure due to gastric distention.

Our research is a prospective, randomized, controlled method study.The aim in this study is to reveal most accurate placement technique and device to transfer this method to clinical applications. Patients will be evaluated in two groups.

Group 1: Placement with SaCoVLM™ video laryngeal mask Group 2: Placement of the LMA Supreme with standard technique

After LMA Supreme and SaCoVLM™ video laryngeal mask placement, airway sealing pressures will be measured with appropriate technique. Airway tightness pressure measurement will be made with the technique accepted in the literature through the sensors in the anesthesia machine.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years
* BMI \< 35 kg/m2
* ASA (American Society of Anesthesiologists) physical score I/II
* Elective surgeries lasting less than 90 minutes

Exclusion Criteria:

* Patients who are expected to have a difficult airway
* Those with potential risk of regurgitation (severe reflux, presence of hiatal hernia)
* Those who will undergo head and neck surgery, laparoscopic surgery
* Those who will undergo surgery in the prone position
* Emergency surgical interventions
* Those requiring muscle relaxants
* Presence of oral abscess, pharyngeal pathology
* Those who have had an upper or lower respiratory tract infection in the last 4 weeks
* History of allergy to medications used
* Failure to obtain the consent of patients or their families
Feasibility of a Patient Directed Tool to Assess Heart Health Among Endometrial Cancer Survivors

Investigators are conducting this study to find out more about what heart health means to participants and how healthcare providers can best help to manage heart health. Participants will be asked to view an electronic tool designed to promote heart health awareness and help to manage heart health outside of the clinic. This study will provide important information to help investigators develop future programs that improve cancer patient's heart health after they complete their treatment.

Primary Objective: The primary objective of this pilot study is to assess the feasibility of enrolling and completing the heart health assessment among endometrial cancer patients scheduled for routine follow-up care.

Secondary Objectives:

* To assess patient satisfaction with the tool.
* To identify the proportion of patients with non-ideal cardiovascular health scores who report initiating discussions regarding cardiovascular health during their routine oncology appointment.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for a routine surveillance visit for pathologically confirmed stages I-IV endometrial cancer
* Greater than or equal to 3 months post-potentially curative cancer treatment
* Patients must be at least 18 years of age
* Have a working email address
* Comfortable reading medical information in English, as per self-report

Exclusion Criteria:

* Currently receiving treatment (e.g. radiation, chemotherapy, immunological treatments for endometrial cancer)
* Have a history of endometrial cancer recurrence
* Enrolled in hospice care or documentation of life expectancy \< 6 months
CoSeal in Liver and Biliary Surgery in Prevention of Denovo Hepatic Adhesion

Study of phase II: Clinical study national, exploratory, multicentric, prospective, randomized, as a double blind man evaluating the effectiveness and the tolerance of the treatment by a surgical gel of sealing containing polyethylene glycol in the prevention of operational adherences post.3 Study of phase III: Clinical study national, multicentric, prospective, randomized, controlled, as a double blind man comparing a group controls with a group of patients treated by a surgical gel of sealing containing polyethylene glycol in the prevention of hepatic adherences of novo post operational.


Eligibility Criteria:
Inclusion Criteria:

* Major patients.
* Hepatic Carriers of metastases.
* Eligible with a procedure of surgical eradication in two brought closer times (time lower than 3 months).
* Strategy validated in multidisciplinary meeting of cancerology.
* Enlightened Assent given and signed before the intervention.

Exclusion Criteria:

* Anaesthetic Counter-indications with a procedure in two times
* Carcinose péritonéale, reached metastatic not éradicable
* Over-sensitiveness or allergy known to polyethylene CoSeal glycol
* Concomitant Use of another antiblocking agent
* Immunodéprimés Patients or taking drugs immunodépresseurs with the long court like the corticosteroids,
* Impossibility of subjecting itself to the medical monitoring imposed by the study for reasons geographical, social, psychic or medical.
* Concomitant Participation in another clinical trial
Use of the Atkins Diet for Children With Intractable Epilepsy: A Comparison of Daily Carbohydrate Limits

This study is designed to further investigate the use of a modified Atkins diet for children with intractable, daily seizures. It is a follow-up to a study recently completed by our institution. In this 6-month study, children will be randomized to either 10 or 20 grams of carbohydrate per day, then crossed over to the opposite amount at 3 months.


Eligibility Criteria:
Inclusion Criteria:

* Ages 3-18
* Daily seizures or 7 per week
* Failed at least 2 anticonvulsants

Exclusion Criteria:

* Prior use of the Atkins diet for over 1 week
* Significant heart, liver, or kidney disease
Basal Bolus Insulin Versus SSRI in Type 2 Diabetes Undergoing General Surgery

High blood glucose levels in surgical patients with diabetes are associated with increased risk of medical complications and death. Improved glucose control with insulin injections may improve clinical outcome and prevent some of the hospital complications. In patients who have undergone surgery, high blood glucose increases the risk of wound infection, kidney failure and death. It is not known; however, what is the best insulin regimen in patients who will undergo surgery. The use of repeated injections of regular insulin is commonly used for glucose control in hospitalized patients with diabetes. Recently, the combination of Lantus® and Apidra® insulins has been shown to improve glucose control with lower rate of hypoglycemia (low blood sugar). We hypothesize that in patients with type 2 diabetes admitted to general surgery wards, treatment with once daily glargine (Lantus) plus supplemental glulisine insulin (Apidra®) will produce better glycemic control and a lower rate of hospital complications than treatment with regular insulin per sliding scale (SSRI). The present study aims to determine which insulin treatment is best for glucose control in hospitalized patients with diabetes. Glargine and glulisine insulins are approved for use in the treatment of patients with diabetes by the FDA.

Subjects included in the study will have type 2 diabetes and be admitted to Grady Memorial Hospital, Veterans Administration Medical Center, and Emory University Hospital, Atlanta, Georgia. A total of \~94 patients will be recruited at each institution.

A post-hoc cost analysis of hospitalization costs and charges of the Rabbit surgery trial will be completed in order to determine differences in hospitalization cost between basal bolus insulin and SSI regimen.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females between the ages of 18 and 80 years admitted to a general surgery service.
2. Patients admitted for non-cardiac elective or emergency surgery or trauma.
3. A known history of type 2 diabetes mellitus \> 3 months, receiving either diet alone or any combination of oral antidiabetic agents (sulfonylureas, metformin, thiazolidinediones).
4. Subjects must have an admission blood glucose \> 140 mg and \< 400 mg/dL without laboratory evidence of diabetic ketoacidosis (serum bicarbonate \< 18 mEq/L or positive serum or urinary ketones).

Exclusion Criteria:

1. Subjects with increased blood glucose concentration, but without a known history of diabetes (stress hyperglycemia).
2. Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria.
3. Acute critical illness or CABG surgery expected to require prolonged admission to a critical care unit (ICU, CCU, SICU, Neuro ICU).
4. Patients with clinically relevant hepatic disease or impaired renal function, as shown by a serum creatinine ≥ 3.5 mg/dl.
5. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
6. Female subjects are pregnant or breast feeding at time of enrollment into the study.
Impact of a Patient Decision Aid Intervention

Studies evaluating decisions aids have used a wide range of outcome measures as well as formats and settings. Most studies have focused on patient decision aids used either within the consultation or delivered pre-consultation, but there are no randomised, controlled studies comparing the two. However, timing and format of the patient decision aid intervention may affect how useful the tool is to the patient. The aim of this project is therefore to deepen our understanding of the patient's engagement in and preparation for the decision making process in a randomised, controlled trial comparing an electronic pre-consultation and paper-based in-consultation patient decision aid. 274 patients with colorectal and breast cancer are enrolled in the study. Data are collected at both patient and consultant perceived levels as well as an observed level of shared decision making.

A cancer diagnosis is life-changing and followed by complex decisions about treatment options. Often the decision about which treatment to choose is based on risks and benefits, although the benefit-harm ratios are unknown. In these situations, a patient decision aid can be helpful in explaining the options, clarifying the patient's preferences and acting as an adjunct to the clinician's counselling, supporting the patient in complex decisions about their diagnosis.

Studies evaluating patient decision aids have used a wide range of outcome measures as well as formats and settings. Most studies have focused on patient decision aids used either within the consultation or delivered pre-consultation, but there are no randomised, controlled studies comparing the two. There is a lack of evidence of the impact of patient decison aids used pre-consultation versus in-consultation, as timing and format of the patient decision aid intervention may affect how useful the tool is to the patient. The aim of this project is therefore to deepen our understanding of the patient's engagement in and preparation for the decision making process in a randomised, controlled trial comparing a digital pre-consultation and paper-based in-consultation patient decision aid. 274 patients with colorectal and breast cancer are enrolled in the study. Data are collected at both patient and consultant perceived level as well as an observed level of shared decision making (SDM).

A secondary analysis of the data collected in the study will form the basis of a study testing the convergent validity of the patient-reported measures by comparing them to the observed level of patient involvement. During the last decade, the strong move towards increased SDM has led to development of several measurement scales, and there is a demand for convergent validity studies, as there is no gold standard to evaluate SDM behaviors. Previous validity studies have various shortcomings.

Eligibility Criteria:
Inclusion Criteria:

* Histologically verified breast or colorectal cancer
* Age ≥ 18 years

Exclusion Criteria:

* Unable to read Danish
* Not the owner/user of a mobile smartphone
Circadian Thermal Sensing to Detect Breast Disease

The purpose of this study is to determine if Cyrcadia's Circadian Biometric Recorder (CBR™), which is attached to soft biometric patches worn on the body, can improve early breast cancer detection along with mammography or as a stand alone device.

The Cyrcadia CBR™ (Circadian Biometric Recorder) includes wearable biometric patches and a detachable data recording device. The CBR™ records chronobiologic data while the patient is totally ambulatory and going about her normal daily routine. Following removal of the detachable data recording device from the wearable biometric patches, the data is transferred to a computer for analysis. The Cyrcadia CBR™ will be placed on the patient for the duration of 2 to 24 hours. There is no restriction of daily activity. The study subject is requested to sponge bathe rather than shower while wearing the device, keeping the device dry during the testing procedure. After this period, the CBR™ will be removed and the data will be transferred to a computer for analysis.

The primary endpoint of this 173 patient study is to determine the accuracy of Cyrcadia CBR™ as a supplemental screening device to mammography and ultrasound in predicting a diagnosis of breast cancer. Specific emphasis will be on the utilization of the CBR as a secondary screening device to reduce the number of biopsies currently performed on non-cancerous tissue. A secondary emphasis will be on the CBR to act as an improved screening solution over mammography specifically in those patients with dense breast parenchymal tissue.

Other endpoints of the study are:

* to determine the accuracy of Cyrcadia CBR™, including the positive predictive value, negative predictive value, false negative rate and false positive rate.
* to determine the optimal wear time for the Cyrcadia CBR™.
* to demonstrate substantial equivalent or improved results when applied to Cyrcadia original patient case study with identical advanced neural network analysis computational results.

Study subjects will be followed at 6, 12, 18, and 24 months to update their clinical status.

Eligibility Criteria:
Inclusion Criteria:

* Women with a BI-RADS category 4 or 5 designation on mammogram
* Women with a BI-RADS category 4 or 5 designation on breast ultrasound
* Women with a BI-RADS category 4 or 5 designation on breast MRI
* Women who are willing to undergo a complete evaluation and/or biopsy procedure if recommended by the treating physician

Exclusion Criteria:

* Less than 21 years of age
* Unable to sign the consent form
* Pregnant or lactating
* Physically unable to wear the Cyrcadia CBR™ for 6 hours
* Previous mastectomy
* Any breast surgery or biopsy within the last 90 days
* Any trauma to the breast within the last 90 days
* Any biopsy or treatment for the BI-RADS category 4 or 5 abnormality
* Refusal to undergo recommended diagnostic evaluation of the BI-RADS category 4 or 5 abnormality
Phase III Study of Rosuvastatin and Fenofibrate Versus Rosuvastatin in Mixed Dyslipidemia

Efficacy and safety of combination therapy of rosuvastatin and fenofibrate versus rosuvastatin monotherapy in mixed dyslipidemia patients: A randomized, multi-center, double-blind, phase 3 study


Eligibility Criteria:
Inclusion Criteria:

* 19 \~ 80 years old
* High risk patient to Coronary Heart Disease
* At Visit 1(Screening)

  1. Treated with Rosuvastatin 10mg monotherapy 4weeks prior to this study
  2. 110 mg/dl ≥ LDL-C, 200 mg/dl ≤ TG ≤ 500 mg/dl
* At Visit 2 (Baseline), 110 mg/dl ≥ LDL-C, 200 mg/dl ≤ TG ≤ 500 mg/dl

Exclusion Criteria:

* AST or ALT \> 2X ULN
* Patients with uncontrolled hyperthyroidism (TSH\>1.5X ULN)
* Patients with uncontrolled diabetes (HbA1c ≥ 9%)
* Patients with uncontrolled hypertension(SBP\>160mmHg or DBP\>95mmHg)
* Patients with congestive heart failure(NYHA class III\~IV) or uncontrolled arrhythmia within 6 months
* Patients treated with any investigational drugs within 3 months at the time consents are obtained
* Not eligible to participate for the study at the discretion of investigator
The Effect of Mirror Therapy With Virtual Reality Application on Motor-Sense Acquisition and Quality of Live in Home Care of Stroke Patients

: Aim: Stroke is increasing day by day in our country as in the world. Early rehabilitation after stroke accelerates motor-sensory gains of individuals. This also increases the quality of life. Although there are studies on post-stroke rehabilitation in our country, rehabilitation applications with virtual reality application are very limited. For this reason, the research was carried out to determine the effect of home therapy with virtual reality application on motor-sensory gains and quality of life after stroke.

Material and method: The research was conducted as a randomized controlled experimental study. The universe of the research; Between December 2021 and May 2022, individuals who met the criteria for inclusion in the study who applied for home care to Erzurum Atatürk University Health Application and Research Center Physical Therapy Unit with the diagnosis of loss of movement in the upper extremity after stroke were formed. The sample size for the research was determined by power analysis. In the power analysis, it was determined that a total of 52 people should be reached in order to reach the 95% confidence level at the 0.05 significance level and 80% power at the p\<0.05 significance level. Considering that there may be data losses in the study, it was decided to reach 60 people, 15% more than the sample. "Descriptive Feature Form", "Brunnstrom Staging" and "SF-36 Quality of Life Scale" were used to collect data.In the analysis of data; percentile distribution, chi-square, Fisher-Freeman- Halton Exact test, t-test in independent groups, Repeated Measures ANOVA Test, Friedman Test, One Way ANOVA test, Kruskall Wallis test, and post hoc analyzes (Bonferroni, Games Howell, Dunn) were used.


Eligibility Criteria:
Inclusion Criteria:

* Being literate,
* Be over 18 years old,
* Having sufficient communication skills to be able to answer verbal and written questions and follow instructions,
* To have applied to benefit from home care services,
* Having been diagnosed with stroke and being at least 6 days old,
* Not having advanced vision problems,
* Not having a vertigo problem
* Not being diagnosed with epilepsy
* In Brunnstrom staging, Upper extremity Stage 2 and above

Exclusion Criteria:

* To reside outside the borders of Erzurum province
* Be under the age of 18
* In Brunnstrom staging, the upper extremity is below Stage 2
Comparison Between 2L Coolprep® and Combination of 1L Coolprep® and Bisacodyl as Bowel Preparation

comparison of the use of Colyte® (ascorbic acid mixed polyethylene glycol solution) in two-liter versus one-liter volume and pretreatment with bisacodyl for colonoscopy preparation.


Eligibility Criteria:
Inclusion Criteria:

* willing to consent/undergo necessary procedures
* between the age of 20 and 75 years
* healthy persons planning to have a colonoscopy

Exclusion Criteria:

* history of abdominal surgery except appendectomy
* inflammatory bowel disease
* clinically or laboratory-confirmed ileus (both functional and mechanical)
* malignancy
* clinically severe cerebrovascular, cardiovascular, kidney, liver or hematologic disease
* dementia, cognitive impairment
* the use of prokinetics, antispasmodics, antidiarrheal drugs, laxatives or neuroleptics in 2 weeks
* known sensitivity to the agents used
* Pregnancy, Lactating woman
Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment With DSXS

An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment with DSXS .

Evaluate the potential of DSXS topical product to suppress HPA axis function in patients with moderate to severe scalp psoriasis. Evaluate the efficacy parameters and adverse event (AE) profiles of DSXS topical product administered to patients with moderate to severe scalp psoriasis.

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant, non-lactating females 18 years of age or older.
* IRE-approved, signed informed consent form that meets all criteria of current FDA regulations.

Exclusion Criteria:

* Females who are pregnant, nursing, planning to become pregnant during the duration of the study, or if of child-bearing potential and sexually active and not prepared to use appropriate contraceptive methods to avoid pregnancy.
Immunoglobulin Gene Rearrangement and Repair in Healthy Donors

B-cells ensure humoral immune response against antigens (Ag) thanks to their receptor (BCR). V(D)J rearrangement, somatic hypermutation, immunoglobulin (Ig) class switch and locus suicide recombination are mutational/recombinational processes targeting Ig loci influencing BCR expression. Study of these events is essential for B cell function analysis. Our project will provide the normal reference values using high throughput sequencing-based protocols.


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers aged between 18 and 70
* volunteers free from lymphoid hemopathy, immune deficiency and autoimmune disease.

  3 categories : volunteers between 18 and 34 years of age, volunteers between 35 and 50 years of age, volunteers between 51 and 69 years of age.

Exclusion Criteria:

* any recent vaccination (\< 4 weeks)
* tumoral pathology
* lymphoïd hemopathy
* immune deficiency
* autoimmune disease
* transplanted patients
* inflammatory / systemic diseases
* hypersensitivity or allergies
* treatments likely to modify the immune response :

  * calcineurin inhibitors: ciclosporin, tacrolimus -antimetabolite: azathioprine, mycophenolate mofetil / mycophenolic acid, 6-mercaptopurine, methotrexate
  * cyclophosphamide
  * antilymphocyte serum (rabbit, horse)
  * mTOR inhibitors: everolimus, sirolimus
  * anti-CD25 (anti IL2-R): basiliximab, dacliximab -belatacept (anti CD80-86)
  * abatacept (CTLA4-Ig)
  * OKT3 (Muronomab-CD3, anti-CD23)
  * glucocorticoids: methylprednisolone, prednisone, prednisolone.
  * entuzumab (anti-CD52)
  * rituximab, ocrelizumab (anti-CD20)
  * eculizumab (anti-C5)
  * anakinra (analogue IL1-RA)
  * leflunomide (dihydroorotate dehydrogenase inhibition)
  * bortezomib (proteasome inhibitor)
  * fingolimod (S1P receptor antagonist)
  * alentuzumab (anti CD52)
  * Ig G -antiTNF (etanercept, infliximab, adalimumab, certolizumab)
  * vedolizumab (Anti-integrin α4β7 Ab)
  * ustekinumab (anti-IL12)
  * natalizumab (anti-integrin a4)
  * mitoxantrone (topoisomerase type II inhibitor)
  * tocilizumab (anti-IL6)