cyrilzakka/clinical-trials huggingface dataset:
Pulmonary Evaluation With Ultrasound in Different Levels of PEEP

Patients submitted to general anesthesia and artificial ventilation almost always develop pulmonary atelectasis, which can determine adverse consequences both intraoperatively and postoperatively. It is recommended to use physiological tidal volume (6 - 8 mL / kg of ideal body weight) during the intraoperative period in order to minimize the risk of lung injury. To prevent the formation of atelectasis, minimizing the risk of complications, the use of PEEP has been recommended. At present, there is no way to make an optimal adjustment of PEEP to the needs of each patient, seeking a value that keeps the alveoli open without forming atelectasis and also without areas of hyperdistension.

The aim of this study was to evaluate the agreement between the ultrasound and the electrical impedance tomography - Timpel® (TIE) to detect the beginning of the formation of areas of atelectasis after pulmonary recruitment, with decreasing PEEP values. In addition, the lung ultrasound will be validated for intraoperative use for both adequacy of PEEP, as well as quantitative analyzes of ultrasound images to assess atelectasis.

18 patients (\> 18 years) of both sexes, submitted to general anesthesia, will be prospectively studied. All patients will receive, in addition to the usual monitoring, the monitoring with the electrical impedance tomography and chest ultrasonography, after being anesthetized and under neuromuscular block, being ventilated with an inspired fraction of 50% oxygen (or greater to maintain oxygen saturation \> 96% ), Tidal volume of 6 mL / kg and respiratory rate to maintain expiratory tidal CO2 between 35-45 cmH2O.


Eligibility Criteria:
Inclusion Criteria:

* Participants will be male and female patients, over 18 years of age, who undergo abdominal surgeries (prostatectomies and hysterectomies) and who do not have preexisting pulmonary diseases. They will be approached in the room prior to surgery, at which time the purpose of the research will be explained, besides making clear that it will not entail costs and so little any injury, scar, or damage. If accepted by the patient, the consent form will be applied.

Exclusion Criteria:

* Exclusion criteria for the study will be: patients classified by the American Society of Anesthesiologists Physical status as ASA-3 or above, patients with obstructive and restrictive respiratory diseases, patients with predictable orotracheal intubation difficulties (eg, obese patients) who require Manipulation of the upper airways. Also excluded are patients with pacemakers and patients scheduled for procedures in the thoracic region
Group Intervention in the Nutritional Profile, Stress and Quality of Life in Patients in Cardiopulmonary Rehabilitation

To evaluate the effectiveness of a group intervention in the nutritional profile, in the stress and in the quality of life of patients in cardiopulmonary rehabilitation. Method: Randomized clinical trial using a semi-structured interview, sociodemographic and anthropometric data collection, with 164 participants divided into a control group and intervention group, the Food Frequency Questionnaire, the Lipp Adult Stress Symptom Inventory (ISSL) ) And the SF-12 Quality of Life Assessment Questionnaire. To verify the difference in nutritional profile, stress levels and quality of life between the groups, the chi-square test will be used for categorical variables and within each group the comparison between the moments will be through the MC Nemar test. In the quantitative variables the evaluation of the interaction between group and time will be through Variance Analysis using the design in Repeated Measures. Considering a significance level p \<0.05. Expected Results: It is believed that psychological and nutritional intervention in patients participating in therapeutic groups helps them to elaborate questions regarding the difficulties of coping with the disease in the daily routine and to understand the importance of lifestyle care and healthy habits.


Eligibility Criteria:
Inclusion Criteria:

* Cardiopathy patients over 18 years of age, users of the Center for Cardiopulmonary and Metabolic Rehabilitation of the Cardiology Institute who signed the Term of Free and Informed Consent

Exclusion Criteria:

* Patients not able to respond to questionnaires at the time of application. Patients who do not want to continue responding to the survey.
Effects of Tranexamic Acid Irrigation on Impacted Third Molar Surgery

Tranexamic acid (TXA) is an effective hemostatic agent used to reduce blood loss and the need for transfusion. It is a relatively safe drug with minimal significant side effects. The most commonly reported complications include nausea, diarrhea, and occasional orthostatic reactions. The increased risk of thromboembolic events associated with the drug is the most serious complication; however, this has not been reported in most clinical studies and remains uncertain. Based on experience from other types of surgeries, tranexamic acid appears to be safe for use without an increased risk of venous thrombosis. To mitigate systemic absorption and minimize undesirable side effects, TXA can be applied topically rather than intravenously, reducing the risk of venous thromboembolism.

Topical TXA irrigation has recently begun to be used intraoperatively. In a study conducted by Eftekharian et al., the application of intraoperative 1% TXA irrigation solution during bimaxillary orthognathic surgery was found to be significantly associated with a reduction in intraoperative blood loss compared to placebo. Additionally, the topical application of TXA to the maxillary sinus during endoscopic sinus surgery has been shown to reduce intraoperative blood loss. In the current literature, the use of tranexamic acid irrigation during tooth extraction under local anesthesia has not been reported. Our study aims to demonstrate the effectiveness of TXA irrigation during the extraction of bone-retained teeth and its effect on postoperative edema.

Eligibility Criteria:
Inclusion Criteria:

1. Indicated for the Extraction of Bilaterally Impacted Third Molars with Bone Retention.
2. Systemically healthy patients aged 14-40 years with no bleeding disorders.

Exclusion Criteria:

1. Patients with systemic diseases affecting general health.
2. Patients diagnosed with any bleeding disorder.
3. Patients with advanced infection or cysts associated with the impacted tooth.
Functional Outcome in Patients That Underwent Laparoscopic Sigmoid and/or Rectum Resection

Questionnaire To assess the functional outcome in patients that underwent laparoscopic sigmoid and/or rectum resection.

A questionnaire will be sent to every patient by mail. The questionnaire that will be used is the COREFO questionnaire (ColoRectal Functional Outcome).

Depending on the amount of responses, we will try to make connections between peri-operative data and functional outcome after considerable period of follow-up. Peri-operative factors include grade of endometriosis, surgical technique and post-operative complications.

Eligibility Criteria:
Inclusion Criteria:

* Patients that underwent laparoscopic sigmoid and/or rectum resection with the indication of deep infiltrating endometriosis

Exclusion Criteria:

-
Haemodialysis Outcomes & Patient Empowerment Study 02

Pilot-scale, single-arm,observational study to assess the utility and acceptability of a wearable hydration monitor in haemodialysis patients compared with bioimpedance and haemodialysis machine data.

Pilot-scale, single-arm,observational study to assess the utility and acceptability of a wearable hydration monitor in haemodialysis patients compared with bioimpedance and haemodialysis machine data.

The Sixty device uses diffuse reflectance spectroscopy to measure fluid status.

20 patients will be assessed during the study observation period.

10 patients undergo an observation period of approximately three weeks. The patients will be asked to wear the Sixty device during dialysis and at night throughout the study observation period.

Following the completion of this 3 week observation period, an additional 10 patients will wear the Sixty device as per the protocol for 3 weeks.

Haemodialysis parameters will be assessed as usual during the study.

Bioimpedance measurements will be taken pre and post-dialysis once weekly during the mid-week dialysis session:

Patient-reported symptoms related to haemodialysis will be recorded, including symptoms of hypervolaemia and hypovolaemia.

Eligibility Criteria:
Inclusion Criteria:

* On haemodialysis in an ambulatory care setting.
* Demonstrates understanding of correct use of the Sixty device.
* Capable and willing to measure blood pressure at home on a daily basis.
* Willing to give written informed consent.

Exclusion Criteria:

* Conditions precluding use of bioimpedance (e.g. Implantable Cardioverter Defibrillator, pacemakers, hearing aids, pregnancy).
* Significant confusion or any concomitant medical condition, which would limit the ability of the patient to record symptoms or other parameters.
Effectiveness of Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT) for Children With Post-traumatic Stress Disorder (TreatChildTrauma)

This multi-site randomized controlled trial compares the effectiveness of Trauma-Focused Cognitive-Behavioral Therapy (TF-CBT) as developed by Cohen, Mannarino \& Deblinger (2006) with a wait-list condition in a population of children aged 7-16 years who were exposed to traumatic events beyond the age of three years, at least three months ago, and developed Posttraumatic Stress Disorder (PTSD). Primary aims are to provide evidence that TF-CBT exceeds spontaneous remission of posttraumatic stress symptoms and to assess maintenance of treatment gains at 6 and 12 months post-treatment. Secondary aims are to evaluate the effectiveness of TF-CBT in reducing other psychopathology and cognitive distortions of patients and caregivers and to explore moderators and mediators of treatment response. The trial will contribute to implement an evidence-based treatment for traumatized children across a variety of healthcare settings in Germany. The novel aspect is to evaluate the effectiveness of TF-CBT with a broad range of traumatized "real-world" patients in the context of the German mental healthcare system.

Complete study protocol (in German) available from the PI lutz.goldbeck@uniklinik-ulm.de

Eligibility Criteria:
Inclusion Criteria:

* Age 7-16 years
* Exposure to a traumatic event (index trauma) after the age of 3 years, at least 3 months before assessment
* ≥35 points on the Clinician -Administered PTSD Scale for Children and Adolescents (CAPS-CA) total symptom severity score and at least one symptom per PTSD cluster related to the index trauma according to DSM IV diagnostic criteria
* PTSD should be the main mental health problem, patients with co-morbid mental disorders are included
* No major brain injury of the child due to the traumatic event (Glasgow Coma Scale \<9 points at primary medical examination)
* Co-operation of at least one non-offending primary caregiver (improves treatment outcome)
* Living within reasonable distance (max 1 hour of travel) to the treatment center to allow treatment on a weekly basis (feasibility)

Exclusion Criteria:

* Psychosis
* Acute suicidality
* Psychopharmacological medication started or changed up to 6 weeks before first assessment
To Evaluate the Bioavailability of a Tablet of AZD1656

To evaluate the bioavailability of a tablet of AZD1656.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, type I diabetes patients, female with non child-bearing potential.
* Treated with insulin for more than 3 years. Well controlled HbA1c.
* Have a body mass index (BMI) ≥19 and ≤35

Exclusion Criteria:

* Clinically significant illness except type I diabetes, or clinically relevant trauma, as judged by the investigator, within 2 weeks before the first administration of the investigational product
* Daily use of nicotine containing substances.
Impact of Patient Position on the Success in Placing Triple-cuffed Double Lumen Endotracheal Tube

Triple-cuffed double lumen endotracheal tube (TC-DLT, ANKOR tube. Insung corp., Korea) which was developed to isolate lung without endotracheal bronchoscope guidance has additional carinal cuff placed between bronchial tube cuff and tracheal tube cuff. This device has been successfully used to isolate lung more simply in specific settings when there is too much excretion to visualize endotracheal structure or for a health provider who is not good at use of traditional double-lumen tube. Although TC-DLT is designed to enable lung separation effectively in situations that confirmation of tube position using bronchoscopy is difficult or not available, but no studies have been conducted on whether effective lung isolation using TC-DLT is possible after change in the relative position of the bronchial tree by postural change. This plan was prepared for research on this.

After enter into operating room, induction of anesthesia is performed through standard general anesthesia procedure before endotracheal intubation. Endotracheal intubation is performed using TC-DLT and inflate carinal cuff with 5 \~ 15ml of air. Then, push it into trachea until resistance is felt. When carinal cuff is placed at carina, deflate carinal cuff and isolate independent lung followed by confirmation of bronchial cuff position using fiberoptic bronchoscopy.

Record the location of the bronchial balloon in one of the following conditions

1. at proper position(proximal upper end of bronchial balloon is between 5mm from carinal opening) :
2. proximal end of bronchial balloon is placed more of 5mm distally from carinal opening
3. proximal end of bronchial balloon is placed more of 5mm proximally from carinal opening

Then, change patient position to left lateral decubitus (LLD) position and check the position of bronchial balloon using fiberoptic bronchoscopy as previously done.

1. at proper position(proximal upper end of bronchial balloon is between 5mm from carinal opening) :
2. proximal end of bronchial balloon is placed more of 5mm distally from carinal opening
3. proximal end of bronchial balloon is placed more of 5mm proximally from carinal opening

After check whether there is something to considerate, end this case.

Eligibility Criteria:
Inclusion Criteria:

* Adults who is including in ASA class I or II
* Patients scheduled for right lung surgery under right lung isolation
* Patients who don't have any anatomical variations in pulmonary system
* Patients who have never gotten a lung surgery

Exclusion Criteria:

* Pregnancy
* Patients who are predicted difficult intubation
* Patients who is under upper airway infection
* Patients who have coagulopathy
* Emergency surgery
* In addition, patients considered inappropriate to participate in this study
Filling Pressures of the Left Ventricle in Patients With Significant Aortic Stenosis

Left valvular heart disease has become one of the most common heart disease in Western countries. This disease evolve over many years and are characterized by a long phase where the patient is "asymptomatic".

it is characterized by discomfort LV filling may worsen and lead typically to a pressure increase of LV pressure and the left atrium (LA) (1). The onset of symptoms is unpredictable and may occur at the stage of diastolic or systolic dysfunction.

Ventricular dysfunction may be insidious, the goal is to detect early dysfunction, knowing that it is often very difficult to know if the patient is actually symptomatic. The onset of symptoms sign an intolerance to the increase in LV filling pressures and LA , causing pulmonary hypertension .

Therefore, the study of the level of LV and LA filling pressures , if possible by a noninvasive method, would identify patients apparently asymptomatic even though their condition is advanced.

Pressures filling pressures can be explored by two methods:

* cardiac catheterization, which is a direct and invasive measurement method
* echocardiography, which is an indirect measurement method which has the advantage of being non-invasive The goal of this research is to compare the two methods.


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years;
* Patients hospitalized for a coarctation review, and has received or will be receiving during their stay a complete echocardiography and coronary angiography, and left and right catheterization

Exclusion Criteria:

* Pregnant women
* Patients with a history of valve replacement surgery,
* Patients with other valvular\> grade 2 associated with the coarctation
* Patients known to have ischemic heart disease or in whom angiography showed significant coronary artery disease;
* Patients with chronic or paroxysmal atrial fibrillation
* Patients with a permanently pacemaker
Clinical Evaluation of Two Silicone Hydrogel Daily Disposable Contact Lenses

The purpose of this investigation is to evaluate the short-term, clinical performance of two silicone hydrogel daily disposable contact lenses.


Eligibility Criteria:
Inclusion Criteria:

* The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
* The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
* The subject must be between (and including) 18 and 39 years of age.
* The subject must be an adapted wearer of spherical soft contact lenses in both eyes. That is, the subject must wear their habitual lenses at least five (5) days per week and eight (8) hours per day worn for at least 30 days immediately preceding the study.
* The subject must have vertex-corrected distance refraction that allows a plano over-refraction with the available contact lens powers of -0.50 to -6.00 Diopters (D) in each eye.
* The subject must have refractive astigmatism, if present, of less than or equal to 1.00 D in each eye.
* The subject must have best corrected visual acuity of 20/25 or better in each eye.

Exclusion Criteria:

* Currently pregnant or breastfeeding (subjects who become pregnant during the study will be discontinued).
* Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
* Any autoimmune disease or use of medication, which may interfere with contact lens wear.
* Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
* Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.).
* Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
* Any ocular infection.
* Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
* Monovision, multi-focal, toric, or extended wear contact lens correction.
* Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
* History of binocular vision abnormality or strabismus that is likely to affect successful contact lens wear.
* Any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., HIV) by self-report.
Multiparametric MRI as a Non-Invasive Biomarker of the Tumor Microenviroment

This study is looking at how an imaging test could help doctors understand if a patient with early breast cancer will respond to drugs that use the patient's immune system to fight cancer.

Primary Objective:

- To evaluate serial multiparametric MRI as an early marker for tumor immune response to an immune checkpoint inhibitor agent

Secondary Objective:

* To assess the potential of early treatment imaging changes on MRI to discern final tumor treatment response
* To assess the prognostic potential of MRI features

Correlative:

* To correlate MRI features with immunophenotypes (i.e. hot and cold tumors)
* To evaluate the association of MRI features with other known biomarkers of immune checkpoint inhibitor response

Eligibility Criteria:
Inclusion Criteria:

Women and men at least 18 years of age.

* Have a new diagnosis of invasive breast cancer with clinical stage I - III disease or regional stage IV with metastasis to the supraclavicular nodes only
* Hormone receptor negative (estrogen-receptor \< 5% and/or progesterone-receptor \< 5%)
* Human epidermal growth factor receptor 2 (HER2) negative by immunohistochemistry or fluorescence in situ hybridization (FISH)
* Enrollment in a neoadjuvant clinical trial that includes the evaluation of immunotherapy as a part of the regimen; patient must be randomized to a treatment arm (including the control arm) prior to enrolling in this study
* Planning to undergo surgical resection and subsequent adjuvant therapy as per the treatment clinical trial or the clinical provider
* Have tissue available for additional correlative studies OR planned to undergo an additional pre-treatment biopsy for additional tissue acquisition as per provider or the treatment clinical trial
* Be a candidate for MRI imaging.
* Be willing to comply with scheduled visits required for the trial.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Systemic or locoregional treatment for the current episode of breast cancer prior to baseline breast MRI.

* Poor visualization of the tumor on the initial breast MRI (investigator discretion)
* Pregnant or nursing.
A Clinical Study to Assess the Physiologic Effects of KB109 in Patients With COVID-19 on Gut Microbiota Structure and Function

This exploratory, open-label clinical study aims to explore the physiologic effects of KB109, a novel glycan, on adult patients with COVID-19 illness on gut microbiota structure and function in the outpatient setting.


Eligibility Criteria:
To be considered for enrollment into this study, each patient must meet all of the following Inclusion Criteria:

1. Be male or female, ≥18 years of age
2. Be willing and able to give informed consent
3. Screening/Randomization telemedicine visit within 2 days of testing positive test for COVID-19
4. Having self-reported fever or cough for not more than 72 hours prior to COVID-19 testing
5. Mild to moderate COVID-19
6. Able to adhere to the study visit schedule and other protocol requirements

Patients who meet any of the following Exclusion Criteria at the Randomization Visit will not be enrolled into the study:

1. Patients who are hospitalized for in-patient treatment or currently being evaluated for potential hospitalization at the time of informed consent for conditions other than COVID-19
2. History of chronic lung disease
3. Ongoing requirement for oxygen therapy
4. Shortness of breath in resting position
5. Diagnosis of sleep apnea requiring Bilevel Positive Airway Pressure (BIPAP) / Continuous Positive Airway Pressure (CPAP)
6. Female patients who are pregnant, trying to become pregnant or lactating.
7. Is considered, in the opinion of the PI, to be unlikely for any reason to be able to comply with study procedures