cyrilzakka/clinical-trials huggingface dataset:
The Effects of Erector Spinae Plane Block on Bariatric Surgery.

The erector spinae plane block (ESPB) is a new technique that is increasingly used in the treatment of acute and chronic pain. Bariatric surgery is a surgical treatment method used in the treatment of morbid obesity and related comorbidities. Providing pain control in obese patients is a topic that remains up-to-date. Poorly controlled early postoperative pain impairs quality of recovery, increases the risk of postoperative pulmonary complications, and is a risk factor for the subsequent development of chronic pain. Therefore, optimizing acute postoperative analgesia is a priority in patients undergoing bariatric surgery. The primary aim of this prospective, randomized study is to evaluate the effect of ESPB on quality of recovery with the QoR-40 questionnaire in patients undergoing elective Laparoscopic Bariatric Surgery.

In the operating room, all patients will receive standard monitoring, including electrocardiography, non-invasive blood pressure, and peripheral oxygen saturation. Patients in the ESPB group will be placed in a sitting position. A convex probe ultrasound transducer will be placed in a longitudinal parasagittal orientation approximately 3 cm lateral to the spinous process. The needle tip was advanced until it will be located in the inter-fascial plane deep to the erector spinae muscle group and superior to the transverse process. Once in position, bupivacaine 0.25%, 20 ml was injected under ultrasound, guidance. The same procedure will be repeated on the contralateral site. Standard perioperative and postoperative analgesia protocol will be given and postoperative pain levels will be determined by Numerical Rating Scale (NRS). NRS scores for pain and postoperative opioid consumption will be recorded on the 15th,30th minute, 1st, 2nd, 12th, 24th hour, 2nd day. Quality of recovery-40 (QoR-40) scores will be given on the ward, at postoperative 24th hour, 3rd and 7th day ( the 3rd and 7th-day scores will be calculated after telephone interview if the patient will be discharged from the hospital).

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for elective laparoscopic bariatric surgery

Exclusion Criteria:

* a history of allergy to local anesthetics
* known coagulation disorders
* infection near the puncture site
* Chronic opioid intake
* Patient with psychiatric disorders
* Can not communicate in Turkish
A Study of BMS-833923 With Cisplatin and Capecitabine in Inoperable, Metastatic Gastric, Gastroesophageal, or Esophageal Adenocarcinomas

The purpose of this study is to determine the maximum tolerated dose (MTD) of BMS-833923 administered in combination with Cisplatin and Capecitabine as first-line therapy in subjects with inoperable metastatic gastric, gastroesophageal or esophageal adenocarcinomas.


Eligibility Criteria:
For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.

Inclusion Criteria:

* Esophageal, gastric, or gastroesophageal adenocarcinoma that has spread and cannot be treated with surgery. The diagnosis must be confirmed by a trained pathologist.
* Prior radiation therapy is allowed in certain circumstances - discuss with your doctor.
* Individuals who have had surgery may be eligible after recovering from the procedure.
* Individuals who have received chemotherapy for the treatment of their disease within the past 6 months are not eligible. Chemotherapy given more than 6 months ago is permitted.
* Individuals with spread of their cancer to the brain are permitted in certain circumstances - talk with your doctor.

Exclusion Criteria:

* Significant heart disease.
* Women pregnant or breastfeeding.
* Women able to bear children who are unwilling or unable to use an acceptable method to avoid pregnancy.
* Uncontrolled medical condition or active infection
* Inability to swallow pills.
* Inability to undergo a blood draw, in which a needle is used to obtain blood from a vein in your arm.
* Individuals receiving another drug not approved by the Food and Drug Administration (FDA) or similar agency in another country.
* Prisoners or individuals currently receiving treatment for a mental or physical illness as an inpatient in a hospital.
* Individuals who have experienced pancreatitis, an inflammation of the pancreas, in the past, or who have had a computed axial tomography (CT) scan showing pancreatitis.
Nutritional Support and Telemedicine

The aim of this clinical trial is to assess the implementation of an APP to track the nutritional status and diet habits of "chronic complex patients"(CCP) in order to improve their nutritional status and evaluate the level of adherence to dietetic counseling.

The aim is to evaluate the usage of an APP and track the nutritional status of "chronic complex patients"(CCP) in order to improve their nutritional status.

This is a study of an experimental design, referring to a controlled randomized trial with CCP in the Moises Broggi hospital.In the first stage, there's been an elaboration of the contents of the APP. For the assessment of the strategy of food education, two groups of patients will be defined(Intervention group (IG) \& Control group (CG)). In each group there will be 91 subjects, meaning a total of 182 patients. Inclusion criteria: \>18 years old, CCP with either malnutrition, or risk of malnutrition (MNA\<23,5), therapeutic profile \<3, living at home, with full accessibility and capable to use a smartphone, and usual internet consumers (patients or caregivers), and who need to sign the informative consent. The inclusion of this study, will be made through a random sampling and patients will be assigned to IG or CG. All patients will undergo an initial evaluation, a follow-up visit after the first 6 months, and then a final visit after 12 months. The intervention group will also contain an educational, and nutritional program by means of the APP throughout the entire study, and data will be collected through a telematic questionnaire between visits. The variables to study are nutritional, diet, clinics, social and valorisation tools ICT (IG).

Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* polymorbidity
* malnourished patient or patient at risk of malnutrition (MNA≤23.5)
* patient living at home, with access to and able to use a smartphone and regular internet users (patients or caregivers)
* patient who agrees to participate in the study by signing the informed consent form

Exclusion Criteria:

* established artificial nutrition
* advanced dementia
* admission to a nursing home/social care for a period of \>1 month
* patients not responding to the telematic visits on more than 2 occasions.
Investigation of the Effects of Pressure Support Ventilation and Positive Airway Pressure Modes During Extubation

Controlled ventilation is applied to patients intubated for general anesthesia. Additionally, positive end-expiratory pressure (PEEP) and pressure support are mechanical ventilation modes that have been used in general anesthesia practice for many years. When the recovery-extubation phase is reached, intermittent bag-mask ventilation is usually used and the patient is allowed to breathe spontaneously and is extubated when an adequate respiratory level is reached. It has been shown in previous studies that the use of intermittent mask ventilation causes postoperative atelectasis. Different methods have been used to prevent postoperative atelectasis. In our study, we aimed to observe the effect of terminating general anesthesia at the end of the operation and using PEEP and pressure-supported ventilation during the extubation phase on early complications.

After informed consent was obtained from the patients, monitoring was performed as we practice in routine anesthesia practice. Pressure controlled ventilation (PCV) mode and positive end-expiratory pressure (PEEP) were used as the mechanical ventilation mode after intubation. After the operation was completed, PCV mode on the mechanical ventilator was continued until the patient was extubated. Afterwards, patients were extubated if they complied with verbal commands and/or swallowed and/or coughed in response to vocal stimuli, pupils were in the midline and conjugated, BIS value was \>80, breathing was regular, and TOF response was \>90%. Hemodynamic and respiratory system complications were recorded during the intraoperative, recovery-extubation and postoperative periods. Patients over the age of 18 with American Society of Anesthesiology physical classification (ASA) 1-3 who underwent laparoscopic cholecystectomy were included in the study. In the preoperative period, the patient's demographic data and hemodynamic data, and in the intraoperative period, respiratory data (tidal volume, pressure applied during inspiration, peep, etc.) and hemodynamic data were recorded. Complications recorded during recovery-extubation; desaturation, laryngospasm, bronchospasm, agitation, rescue mask ventilation application, airway obstruction, nausea-vomiting, re-intubation, struggling.

Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18 with American Society of Anesthesiology physical classification (ASA) 1-3 who underwent laparoscopic cholecystectomy were included in the study

Exclusion Criteria:

* The patient does not want to participate in the study.
* Known advanced lung disease, advanced-stage heart disease
* Switching from laparoscopic surgery to open surgery
* Surgical procedure exceeds 120 minutes
* intraoperative bleeding \>500 ml
Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of the Thoracoabdominal and Pararenal Aortic Aneurysms (TAMBE)

Expanded access tothe GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis is safe and effective in the treatment of thoracoabdominal and pararenal aneurysms.

Gore will permit the use of the TAMBE Device in a manner consistent with the approved CIP provided that its use is needed to treat a serious, but non-life-threatening condition. In the requesting physician's opinion, there must be no acceptable alternative treatment option. Patients are to be consented with an Emergency / Compassionate Use ICF template provided by Gore upon request for this type of device use. Sites will be required to fill out a packet justifying the rationale of use as well as their plan to conduct follow-up surveillance on the non-study subject. Upon performance of the case, the site will immediately notify Gore and provide supporting documentation to facilitate timely, compliant regulatory reporting.

Eligibility Criteria:
• Aortic aneurysm involving the visceral vessels requiring treatment defined as at least one of the following: Fusiform aneurysm diameter ≥ 5 cm Saccular aneurysm (no diameter requirement) Rapid aneurysm growth (≥ 5 mm in one year)

* An Informed Consent Form signed by Subject or legal representative
* Appropriate aortic anatomy to receive the TAMBE Device d
Retrospective Study Assessing Molecular Features Predicting Response to Cetuximab

The primary objective is to identify molecular features predicting response or resistance to cetuximab

Secondary objective is to investigate association of genomic status of EGFR and HER-2 genes with clinical outcome, including objective response, time to progression and survival

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of colorectal cancer with available tumor tissue and clinical data; presence of at least one measurable lesion.

Exclusion Criteria:

* Less than 3 weeks after completion of previous radiotherapy
Assessment of Sarcopenia at Diagnosis for Patients With Previously Untreated Metastatic Cancer or Hematologic Malignancy

Sarcopenia is defined as reduction in muscle mass and function according to the criteria of the European Working Group on Sarcopenia in older people. Initially described for elderly patients, it is also presented as a negative prognostic factor in overall survival in oncology in certain locations (lung, ENT pathways, colon, pancreas) and more controversially for hemopathies. Its screening by measurement of skeletal muscle mass by CT scan and / or PET scan against L3 and by physical functional tests is not routinely integrated despite international recommendations. Sarcopenia is one of the characteristics of patient fragility that can induce more complications, lengthen the average length of hospital stay and reduce overall survival. The PRONOPALL score, a predictor score for survival validated by a previous study, will be correlated with the presence (or absence) of sarcopenia at inclusion for patients with a solid tumor (breast, ovary, prostate cancer , kidney, lungs, pancreas, colorectal). A prospective study on 38 patients with metastatic cancer was carried out at the Victor Hugo clinic in Le Mans between 01/JUN/21 and 31/AUG/21 (SPACE, ClinicalTrials.gov number, NCT04714203): 25 patients were analyzable on the CT and PRONOPALL score data with a prevalence of sarcopenia of 60% and median overall survival of 14 months (unpublished data), clinical performance and muscle strength tests were not carried out (as in the publications cited above).

A prospective study for the detection of sarcopenia is indicated by extending to blood diseases with the integration of clinical tests included in the initial APA (Adapted physical activity) assessment recommended for diagnosis.


Eligibility Criteria:
Inclusion Criteria:

1. Patient aged 18 years or older
2. Patient with solid cancer diagnosed with metastatic disease,or hematological disease requiring treatment (myeloma, lymphoma, high-risk myelodysplasia, acute or chronic myeloid leukemia, acute and chronic lymphoid leukemia)
3. Patient naive of cancer treatment
4. Pathology including performing a CT scan with cuts of the lumbar spine in standard care
5. Patient enrolled in social security
6. Patient has given his written consent ahead of any specific protocol procedure.

Exclusion Criteria:

1. Minor patient
2. Metastatic neurological impairment
3. Patient deprived of their liberty, under guardianship or trusteeship
4. Patient with dementia, mental disorders or psychological pathology which could compromise patient informed consent and/or the observance of the study protocol
5. Patient cannot submit to the protocol for psychological, social, familial or geographical reasons
6. Patient is pregnant
7. History of cancer treated (excluding surgery alone for tumors in situ) within 5 years of inclusion
Frequency Doubling Technology (FDT) Mobile Visual Field Testing

This is a single center, prospective study to evaluate the efficacy and reproducibility of frequency doubling technology (FDT)-based visual field devices compared to conventional Humphrey Visual Field (HVF) perimetry. The investigators plan to enroll 500 patients in this study.

Glaucoma is a leading cause of irreversible and preventable blindness world-wide. Insufficient evidence exists to support routine screening for glaucoma in a primary care setting due to the relatively low prevalence of the disease (Guirguis-Blake, 2005 and Moyer, 2013). Frequency doubling technology (FDT)-based perimetry is a relatively inexpensive and portable visual field testing device with a short testing time that has shown reasonable efficacy, sensitivity and specificity in screening for glaucoma in clinic- and community-based settings (Mansberger, 2005 and Nomoto 2009).

The aim of our study is to compare the efficacy and reproducibility of FDT perimetry platforms compared with Humphrey Visual Field (HVF) perimetry (which is the gold clinical standard in clinics and hospitals) in detecting glaucomatous visual field defects.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18 and over) who speak English, Spanish or Creole, and are capable of providing informed consent and who have a Humphrey Visual Field (HVF) test within the prior the 6 months preceding enrollment are eligible for enrollment in this non-invasive study. Patients will be recruited from among patients at the Bascom Palmer Eye Institute clinics during their regularly scheduled clinic visits. No advertising will be used to recruit patients.

Exclusion Criteria:

* Adults unable to consent, individuals who are not yet adults (infants, children and teenagers), pregnant women and prisoners and other vulnerable populations will be excluded from the study.
Stereotactic Hypofractionated Radiosurgery for Early Stage Prostate Cancer

The purpose of this trial is to evaluate a short course of very focused (stereotactic) external beam radiation therapy for the treatment of early stage prostate cancer.

The investigators will gather scientific information about the tolerance and side effects this type of radiation. The investigators will then compare these results with those of standard 8 week course of external beam radiation therapy to see if this study treatment is equally or more effective in treating prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the prostate
* Gleason score ≤ 6 and low volume Gleason 7 (3+4)
* PSA \< 10
* Clinical Stage of T2a or less
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Prior radiation treatment for prostate cancer
* Gleason score \> 7
* PSA \> 10
* Clinical Stage of T2b or greater
FET-PET/MRI Based Treatment Planning for Glioblastoma Multiforme in Post-Surgical Patients (FET-TREAT)

Glioblastoma multiforme (GBM) represent the most common primary brain malignancy and prognosis remains poor. The most common subtype is glioblastoma which has a 5-year survival rate of approximately 5%. Despite advances in MRI techniques, accurately determining total extent of tumor remains a challenge. The result is incomplete treatment resulting in reduced survival or overtreatment resulting in avoidable treatment related morbidity. A more accurate means of assessing tumor extent is needed to guide management to improve patient survival and quality of life.


Eligibility Criteria:
Inclusion Criteria:

Each participant must meet all of the following inclusion criteria to participate in this study:

* ≥ 18 years of age
* Diagnosis of glioblastoma multiforme
* Post-maximally safe surgical resection
* No prior radiation or systemic treatment for high grade glioma
* Able to tolerate PET/MRI scan with intravenous contrast
* Willing to provide informed consent

Exclusion Criteria:

All participants meeting any of the following exclusion criteria at baseline screening will be excluded from participation in this study:

* MRI contraindication
* Creatinine clearance \< 30mL/min
* Inability to lie still for 60 minutes
* Gadolinium allergy
* Positive pregnancy test
* Breastfeeding
* Patient unable to follow the protocol for any reason
Effectiveness of Simulation With Nursing Students in the Care of Patients With Sepsis

Simulation is an active teaching strategy capable of reproducing real situations and allowing practical experiences, in which the student is the protagonist of his own knowledge. Scientific evidence highlights, that exposure to the unknown or new can generate stress to the individual, but when dosed, to a certain extent it can increase the level of knowledge. Not infrequently, the lack of stress control can trigger physiological and subjective changes resulting from the increase in its level, such as situations that include the implementation of simulation scenarios in pedagogical teaching models.

Objective:

To evaluate the effect of simulation (high and low fidelity) on the cognitive, physiological and emotional sphere of nursing students in caring for patients with signs of sepsis.

Hypothesis of the study:

Null hypothesis: Students undergoing high-fidelity simulation will show similar levels of stress, cognitive performance and retention of knowledge in relation to those who will perform low-fidelity simulation in patients with signs of sepsis.

Alternative hypothesis: The cognitive performance and stress will be higher in students who experience high fidelity simulation when compared to students who experience low fidelity simulation.

Eligibility Criteria:
Inclusion Criteria:

* Students approved in the discipline related to nursing care for adult and elderly patients;
* Aged over 18 years.

Exclusion Criteria:

* Who have experience in the health field (firefighters and nursing technicians, among others);
* Members of the Health Simulation League;
* Those who do not complete all stages of the research.
Evaluation of A Partially Hydrolyzed in Improving FGIDs Symptoms

Evaluation of A Partially Hydrolyzed Whey Protein Infant Formula in Improving Functional Gastrointestinal Disorders (FGIDs) Symptoms

This study will investigate the prevalence of Shanghai area's infant with FGIDs symptom and contrast for the FGIDs symptoms by using different intervention means, and evaluate the effectiveness of FGIDs symptoms in infants by using partially hydrolyzed whey protein and low lactose infant formulation.

Eligibility Criteria:
Inclusion Criteria:

* Infants is formula-fed or mixed feeding a cow milk protein-based formula for less 7 days prior to enrollment.
* Infant is between 30-180 days of age.
* Infant's parent(s) or Legally authorized representative(LAR) has voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) prior to any participation in the study.

Exclusion Criteria:

* Complementary food was added for infants or parents are willing to add complementary food during study.
* Suffer from infection/illness.
* Infant has suspected or known metabolic or physical diseases affecting infant feeding and/or metabolism.
* Infant has visible bloody stools (detected before enrollment) prior to enrollment.
* Participation in another study.