cyrilzakka/clinical-trials huggingface dataset:
Sensitivity and Predictive Value of Frozen Section of Sentinel Lymph Node Biopsy in Post Neoadjuvant Setting

Axillary lymph node status is one of the most important prognostic factors in primary breast carcinomas. Sentinel lymph node biopsy has been increasing in post neoadjuvant setting when axillary nodes show good clinical and radiological response. It allows to determine the axillary lymph node status, which if negative, saves the patient from axillary dissection (AD) and its potential complications. To assess tumor response to neoadjuvant chemotherapy in the SLN, pathological evaluation is the gold standard. Response to neoadjuvant systemic therapy is an excellent predictor of outcome, and achievement of pathological complete response (PCR) in the SLN is a prognostic predictor of long-term outcome with significantly better disease-free survival and overall survival. Post-treatment isolated tumor cells (ITCs) and micro metastases predict worse survival compared with the same findings in the non-neoadjuvant setting. Histologically partial response to therapy, is characterized by small clusters and individual tumor cells set in hyaline stromal fibrosis. Most false negative cases had metastatic foci identified exclusively on permanent sections and are not due to a true diagnostic interpretation error. The timing of further axillary surgery, immediate or a subsequent operation should be routinely discussed at centers using intraoperative assessment of the sentinel lymph nodes, along with the potential for negative intraoperative findings and positive nodes on final pathology.


Eligibility Criteria:
Inclusion Criteria:

1. Patients greater than 18 years of age
2. All diagnosed breast carcinoma patients ranging from T1 to T4 and N0 to N1, who have received neoadjuvant chemotherapy will be included.

Exclusion Criteria:

1. Poorly preserved biopsy material, insufficient to assess all the histological features.
Comparative Evaluation of Simulator Based and Traditional In-surgery Laparoscopic Camera Training's Efficiency in Novices

This prospective randomized study aims for determination whether focused simulator based laparoscopic camera training in novices can improve camera performance in an actual clinical situations in the same manner as traditional training in the OR does, especially considering efficient use of training time.

Medical students in their final years without any significant experience in handling an angled laparoscopic camera participate in the study and perform a camera guidance test in surgery. The participants are then randomized in two groups to receive either a simulator based or traditional in theatre training during three weeks. The camera test will be repeated, while both tests are going to be recorded. Videos of 14 camera tests carried out by laparoscopic experts are taped as well.

Eligibility Criteria:
Inclusion Criteria:

* Medical students on a surgical clerkship rotation at the department of visceral and transplantation surgery of the university hospital of Zurich, Switzerland

Exclusion Criteria:

* Any experience in laparoscopic camera handling in the OR and/or simulator based laparoscopic training
Secondary Prevention of Osteoporotic Fractures in Residents of Long-Term Care Facilities

Osteoporotic fractures of the hip are a major cause of admission to long-term care facilities. Such fractures put patients at high risk for further fractures, pain and disability. Current data show that many patients in long-term care facilities do not receive FDA medications for their osteoporosis. This trial will test whether a multi-model intervention (which provides feedback about provider use of osteoporosis medications, information about osteoporosis, and currently approved osteoporosis medications)directed at physicians, other health care providers, and nurses will improve the number of prescriptions written for FDA approved medications for osteoporosis treatment.


Eligibility Criteria:
Inclusion Criteria:

Any North Carolina long-term care facility with ten residents who had had a hip fracture or osteoporosis diagnosis
Respiratory Variation of Carotid Doppler Peak Velocity (CDPV) for Non-invasive Prediction of Fluid Responsiveness

The purpose of this study is to assess respiratory variation of carotid doppler peak velocity (∆CDPV) for prediction of fluid responsiveness during major abdominal surgery.

Investigating hemodynamic parameters in a group of 19 ICU-patients with septic shock, respiratory variation of carotid doppler peak velocity (∆CDPV) has been shown to be able to predict fluid responsiveness. For patients receiving so called lung protective ventilation with a tidal volume of 6ml/kg ∆CDPV was superior for prediction of fluid responsiveness when compared to other well established parameters such as pulse pressure variation (∆PP).

Likewise in another study ∆CDPV has been shown to be superior to stroke volume variation (∆SV) for prediction of fluid responsiveness in patients with septic shock when ventilated with a tidal volume of ≥8ml/ kg.

All in all respiratory variation of carotid doppler peak velocity (∆CDPV) seems to be a promising parameter for prediction of fluid responsiveness (Yao et al., BMC Anesthesiology 2018). However, so far clinical studies have been conducted only under a small number of patients mainly in the intensive care unit and/ or under highly specific conditions (e.g. cardiac surgery).

If ∆CDPV is able to predict fluid responsiveness with high accuracy intraoperatively remains unknown. The investigators are therefore conducting this prospective monocentric observational trial to evaluate the performance of ∆CDPV during major abdominal surgery and compare it to validated fluid responsiveness monitoring parameters ∆PP and corrected flow time (fTc).

Following IRB-approval and written informed consent 84 patients scheduled for major abdominal surgery will be enrolled in the study. Stroke volume will be monitored by Esophageal Doppler Monitoring (CardioQ-ODM®, Deltex Medical Ltd, Chichester, UK). In case of hypovolemia a fluid bolus of 7 ml/kg ideal body weight will be administered at the discretion of the attending anesthesiologist. Respiratory variation of carotid doppler peak velocity (∆CDPV) will be monitored before and 1 minute after completion of each fluid bolus using an ultrasound device with a common linear array transducer (Philips ClearVue 350, Philips Medizin Systeme GmbH, Boeblingen, Germany).

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years
* written informed consent
* scheduled major abdominal surgery

Exclusion Criteria:

* Age \<18 or \>80 years
* pregnancy
* SIRS or sepsis
* any kind of cardiac arrhythmia
* known valve disease
* known heart failure
* any kind of known carotid stenosis
* carotid doppler peak velocity \>182 cm/s before baseline measurement (expected stenosis)
* missing indication for invasive arterial blood pressure monitoring (IBP) not related to the study
* peripheral artery disease (PAD)
* BMI \> 35 kg/m2
* intraabdominal hypertension
* ASA-PSC of 4
* severe lung disease (e.g. COPD grade 3, fibrosis)
* esophageal disease of any kind
* participation in another clinical study
Registry for Patients Undergoing Pulmonary Procedures

The purpose of this research study is to examine the safety, tolerability, and effectiveness of currently available pulmonary procedures when used to diagnose or treat different diseases.

This study will collect information that may influence the outcome of the procedure and identify factors that may affect the procedures yield or safety. The information will be entered into a registry or data storage.

This is a retrospective and prospective data registry of all pulmonary diagnostic and therapeutic interventional pulmonary procedures at a single academic center. All pulmonary procedures upon completion will be entered into a database by the participating investigator performing the procedure. For both diagnostic and therapeutic cases, the data will require additional input 1-4 weeks after the procedure in order to place the diagnosis and follow-up data. Retrospective data will only be collected for patients that had their procedures prior to approval of this registry.

Study data will be collected and managed using REDCap (Research Electronic Data Capture) electronic data (CTSA Awared - Award Number UL1RR031990) capture tools hosted at Virginia Commonwealth University. REDCap is a secure, web-based application designed to support data capture for research studies.

The prison population will also be included in the registry in order to examine the effects of pulmonary procedures on a special population.

Eligibility Criteria:
Inclusion Criteria:

* ADULT PATIENTS (\>18 YEARS OLD) that have a planned PULMONARY PROCEDURE

Exclusion Criteria:

* ALL KNOWN PREGNANT PATIENTS WILL BE EXCLUDED FROM THIS REGISTRY.
Implementation of Hysteroscopy in Flanders and the Netherlands

By means of a questionnaire the investigators will study the implementation of hysteroscopy in Flanders and the Netherlands

Hysteroscopy is a minimally invasive method for diagnosis and treatment of intra-uterine abnormalities. Complication and failure rates are low because of the direct visualisation of the treated abnormality. Moreover, hysteroscopic procedures replaced 'blind' (curettage) and more invasive interventions (hysterectomy).

The field of hysteroscopy has developed over the years. Changes occurred in hysteroscopic instruments and in the use of energy sources. An important development is the smaller diameter of the hysteroscopic system which makes it suitable for an outpatient setting. Not every gynaecologist, however, has the appropriate hysteroscopic skills or setting to carry out these procedures.

The incorporation of hysteroscopic procedures into daily practice in Flanders is unclear. In the Netherlands 2 surveys were conducted in the past to question the treatment options for polypectomy in an outpatient setting on the one hand and the diffusion of hysteroscopy on the other hand.

The investigators want to study the diffusion of hysteroscopy in Flanders and the Netherlands. Moreover the investigators want to provide an overview of the hysteroscopic procedures implemented, as well as the setting they are performed in.

An electronic questionnaire (LimeService) will be sent to all gynaecologists in Flanders and the Netherlands. Participation is voluntary and anonymous. After informed consent all gynaecologists are asked to complete the first part of the questionnaire containing general information. The second part is specific for gynaecologists performing hysteroscopy themselves, and inquires about the procedures they carry out.

Eligibility Criteria:
Inclusion Criteria:

* gynaecologist

Exclusion Criteria:

* residents in training for gynaecology/obstetrics
Laryngeal Mask Airway as a Bridge for Intubation of Obese Patients for Sleeve Gastrectomy

Ventilation, as well as intubation of a morbidly obese patient, is challenging and require special preparations and skilful hands, in this study laryngeal mask airway insertion is used as a bridge for intubation to facilitate ventilation as give enough time to anaesthetics and muscle relaxants to work on.

The ordinary pathway of intubating a morbidly obese patient for sleeve gastrectomy is bordered by the risk of difficult ventilation and intubation with the subsequent events of hypoxia and hypoventilation. When the patient is easy ventilated, it gives some sort of confidence and pleasure for the anaesthetist that the way of intubation will not be so hard.

One problem here is the difficulty of ventilating a morbidly obese patient, in this study the investigators used laryngeal mask airway as a bridge before inserting the endotracheal tube

Eligibility Criteria:
Inclusion Criteria:

* Morbid obese patient BMI\>40
* ASA I, II, III
* Elective sleeve gastrectomy

Exclusion Criteria:

* Oral cavity infection or pathological abnormalities
* Suspected or known abnormalities in supraglottic anatomy
* Patients planned for awake fiberoptic intubation
Bioequivalence Study

The purpose of this study is to determine if tablets manufactured at different sites have the same bioavailability, that is yield similar blood levels/concentrations of the drugs and are handled by the body similarly

Primary Purpose:

Other: Protocol designed to demonstrate the bioequivalence of the fixed dose combination of 5 mg Saxagliptin and 1000 mg Metformin Extended Release Tablet manufactured in Mt. Vernon, Indiana and Humacao, Puerto Rico relative to the fixed dose combination tablet manufactured in Mt. Vernon, Indiana and the bioequivalence of the fixed dose combination of 5 mg Saxagliptin and 500 mg Metformin Extended Release Tablet manufactured in Mt. Vernon, Indiana and Humacao, Puerto Rico relative to the fixed dose combination tablet manufactured in Mt. Vernon, Indiana in healthy human subjects under fed conditions

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects, 18-45 years of age
* Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive
* Women must have a negative serum or urine pregnancy test within 24 hours prior to the start of investigational product

Exclusion Criteria:

* Any significant acute or chronic medical illness
* Estimated creatinine clearance of \<60 mL/min as calculated using the Modification of Diet in Renal Disease method Current or recent (within 3 months of study drug administration)
* Gastrointestinal (GI) disease that could affect the absorption of study drug
* Inability to tolerate oral medication
* History of allergies or adverse reactions to DPP4 inhibitors or Metformin or related compounds
* Current smoker or recent (within 6 months of study drug administration) history of regular tobacco use (positive cotinine test)
Integrated Pulmonary Index in Gastroscopic Procedures

Various complications are the leading cause of morbidity in sedation practices in endoscopic procedures, and guidelines recommend continuous monitoring of circulation, respiratory function, and ventilation. Integrated Pulmonary Index (IPI), one of the methods that can be used in this monitoring, gives a single numerical value obtained by continuous and simultaneous joint mathematical analysis of Oxygen saturation, End-tidal carbon dioxide concentration, respiratory rate, and heart rate values and is a good monitorization in these interventions. and provides tracking. In this study, the aim is to determine the role of IPI in the diagnosis and follow-up of respiratory complications in patients who were sedated during gastroscopy procedures.

IPI EtCO2 is a monitoring method consisting of respiratory rate, SPO2 and heart rate parameters. While EtCO2 is measured with nasal capnography, SPO2, heart rate, respiratory rate are measured with finger probe and it will show instant measurement of respiratory status. IPI takes values between 1-10. An IPI value of 8 and above will indicate normal values, a value between 5-7 will indicate that the respiratory status of the patient should be carefully examined and intervened if necessary, values of 4 and below will definitely indicate that the patient's respiratory status should be intervened.

Blood pressure measurement will be made with a sphingmomanometer noninvasively at certain time intervals with the help of a cuff that will be placed on the patient's arm area.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1-2-3 risk scored patients,
* patients over the age of 18 who will undergo endoscopic intervention

Exclusion Criteria:

* Patients who need mechanical ventilator support,
* patients who need emergency endoscopic intervention,
* patients with a history of substance abuse,
* patients with a history of allergy to the drugs to be used,
* pregnant women will be excluded from the study.
Exercise and Stress Management Post Autologous and Allogeneic Transplant (BMT CTN 0902)

This is a Phase III, randomized, unblinded, multicenter, prospective comparative study. The purpose of this study is to test whether exercise or stress management training delivered to autologous and allogeneic hematopoietic cell transplantation (HCT) patients prior to transplantation can improve functional status and the transplant experience.

Background:

The adverse effects of hematopoietic cell transplantation (HCT) on short and long term quality of life are well documented. Patients experience numerous aversive symptoms (e.g., nausea, fatigue, and sleep disturbance) that are accompanied by declines in physical and mental well-being. Although most longitudinal studies show return to baseline functioning for the majority of patients, it may take 6 to 12 months or longer to reach this goal. Clinical trials have shown that training in stress management techniques and participation in formal exercise programs each offered in isolation are effective in improving quality of life in patients receiving standard-dose chemotherapy and HCT. Review of these studies suggests that stress management interventions primarily improve mental health outcomes and nausea. The impact of exercise training interventions is more variable; most studies report physical health benefits, with some studies also reporting mental health benefits. Small studies suggest that combining stress management training and exercise are feasible and well-tolerated, but whether the combination provides an additive or synergistic impact on quality of life outcomes has not been directly investigated.

Design Narrative:

The protocol is designed as a factorial trial with two interventions, exercise and stress management, which results in four treatment arms: standard care, exercise only, stress management only and the combination of exercise and stress management. The primary objective of this randomized phase III trial is to test the ability of exercise training or stress management training to improve physical and mental functioning at Day 100 post hematopoietic cell transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Able to speak and read English
* Able to exercise at low to moderate intensity - adequate cardiopulmonary reserve, as judged by self-reported ability to walk up one flight of stairs, no requirement for supplemental oxygen, and physician judgment
* Willing and able to provide informed consent.
* Stated willingness to comply with study procedures and reporting requirements
* Planned autologous or allogeneic transplantation within 6 weeks.

Exclusion Criteria:

* Orthopedic, neurologic or other problems which prevent safe ambulation and protocol adherence
* Participation in another clinical trial with quality of life or functional status as a primary endpoint
Exparel PK and Breast Milk Excretion

Investigate the pharmacokinetics of Liposomal Bupivacaine and its excretion in breast milk in patients undergoing TAP block after their scheduled C -section delivery


Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women \>18 year old, scheduled for elective Cesarean delivery and who desire to have a TAP block performed after delivery.
2. American Society of Anesthesiologists physical status I, II, and III

Exclusion Criteria:

1. Patient refusal or inability to cooperate.
2. Allergy, hypersensitivity, intolerance, or contraindication to liposomal bupivacaine.
3. Severely impaired renal or hepatic function (eg, serum creatinine level \>2 mg/dL \[176.8 µmol/L\], blood urea nitrogen level \>50 mg/dL \[17.9 mmol/L\], serum aspartate aminotransferase \[AST\] level \>3 times the upper limit of normal \[ULN\], or serum alanine aminotransferase \[ALT\] level \>3 times the ULN).
4. Participants at an increased risk for bleeding or with any coagulation disorder (defined as platelet count less than 80, 000 × 103/mm3 or international normalized ratio greater than 1.5) (all contraindications to TAP block).
5. Clinically significant medical disease in either the mother or baby that, in the opinion of the investigator, would make participation in a clinical study inappropriate. This includes any psychiatric or other disease in the mother that would constitute a contraindication to participation in the study or cause the mother to be unable to comply with the study requirements.
6. Patient membership in a vulnerable population such as a prisoner, mentally unable to provide direct consent etc.
7. Participant has contraindication to breastfeeding or not planning to breastfeed the first 2-3 days after delivery.
Role of Surgery for the Primary in Patients With Breast Cancer Stage IV.

The purpose of this study is to determine benefits of surgery for the primary in patients with breast cancer stage IV in randomized controlled study.


Eligibility Criteria:
Inclusion Criteria:

* Healthy breast cancer stage IV patients with resectable primary breast tumor.
* Resectable breast cancer stage IV patients who well response of visceral metastasis to systemic therapy and fit for surgery.

Exclusion Criteria:

* Breast cancer stage IV patients with local complication of primary breast tumor that require surgery for palliation such as uncontrolled bleeding,large and non-healing ulcer or intractable pain.
* Breast cancer stage IV patients with unresectable primary breast tumor or extensive chest wall disease.
Effects of Very Low Calorie Diet vs Metabolic Surgery on Weight Loss and Obesity Comorbidities

It is a prospective randomized trial on 218 subjects, 109 for each arms. The purpose of this trial is to compare very low calorie diet and metabolic surgery induced weight loss and its maintenance.

Obesity is a leading public health issued associated with poor quality of life, morbidity and an increased mortality rate. Although metabolic surgery results in a greater weight loss when compared to non-surgical approaches, a low calorie diet associated with intensive maintenance session may be a valid alternative for weight loss. Since lifestyle interventions are safer and potentially more cost effective than metabolic surgery, this trial will test whether an intensive lifestyle intervention is as effective as metabolic surgery to induce weight loss and its maintenance.

A total of 218 participants will be randomly assigned to metabolic surgery (109) or intensive lifestyle intervention (109).

Clinical outcomes will be assessed at 25% reduction in Body Mass Index (BMI), at 12 months and 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 19 and 69 years
* Body Mass Index ≥35 kg/m2 and at least one or more obesity-related co-morbidities such as type II diabetes (T2DM), hypertension, sleep apnea and other respiratory disorders, non-alcoholic fatty liver disease, osteoarthritis, lipid abnormalities, gastrointestinal disorders, or heart disease
* Body Mass Index ≥40 kg/m2

Exclusion Criteria:

* Pregnancy
* Active cancer
* End stage renal failure
* End stage liver failure
* Being unable to understand and sign informed consent