cyrilzakka/clinical-trials huggingface dataset:
Effects of Tracheal Tube Size on Pulmonary Aspiration

Fluid leak around the cuff is minimized when the endotracheal tube size is small relative to the size of the trachea. In the current study, the investigators assess the influence of different HVLP endotracheal tube size on fluid leakage around the cuff in a benchtop model and in anesthetized patients.

The use of a high-volume and low-pressure (HVLP) endotracheal cuff has reduced the cuff-induced tracheal damage because the cuff conforms passively to tracheal contours as it expands during inflation and the cuff inflation pressure is assumed to be equal to cuff-to-trachea pressure. However, longitudinal folds of a HVLP cuff occur on inflation within the trachea, as the diameter of the cuff is greater than that of the trachea, and these folds provide channels for an aspiration or gas leakage.

Silent aspiration of upper airway secretions has been reported in patients undergoing general anesthesia and in the intensive care unit (ICU). A previous study reported the 83% aspiration of subglottic dye detected by bronchoscopy in anesthetized patients, and other study of intubated patients with HVLP cuffs in the ICU showed 87% aspiration rate.

Intubation-related (ventilator associated pneumonia) pneumonia is a leading cause of prolongation of hospital stay, mortality and morbidity during the postoperative period and in the ICU. Therefore, it is important to achieve a better seal around the cuff without tracheal damage, which would reduce the incidence of pneumonia in intubated patients.

A previous benchtop study demonstrated that the leak around the cuff is minimized when the endotracheal tube size is small relative to the size of the trachea. In the current study, we assess the influence of different HVLP endotracheal tube size on fluid leakage around the cuff in a benchtop model and in anesthetized patients.

Eligibility Criteria:
Inclusion Criteria:

* Male patients, aged 20-65 yr scheduled for elective cardiac surgery under general anesthesia

Exclusion Criteria:

* Patients with an upper airway and vocal cord disease, pneumonia before surgery, a history of tracheostomy and tracheal stenosis.
Prevalence of Aspirin Resistance in Ischemic Stroke Patients at Assiut University Hospital

* This study aims to assess the prevalence of aspirin resistance in patients with acute ischemic stroke and its importance in secondary stroke prevention.
* Effect of aspirin resistance on short and long term mortality and detection of its relationship with recurrence of stroke.

Stroke is the rapidly developing loss of brain functions due to disturbance in the blood supply to the brain. It is the leading cause of adult disability in the United States and Europe and currently the second leading cause of death, ranking after heart disease and before cancer, accounting for 10% of deaths worldwide . About 80-90% of strokes are caused by ischemia, and the remainder by hemorrhage . Arterioarterial micro thromboembolism is an important etiological factor in the pathogenesis of ischemic stroke. Platelet activation in cerebrovascular disease is associated with recurrent stroke and death, while inhibition of platelet function by antiplatelet drugs including aspirin lowers the risk of ischemic stroke. Aspirin is an effective antiplatelet agent, exhibiting its action by irreversibly inhibiting platelet cyclooxygenase-1 enzyme, thus preventing the production of thromboxane A2 (TXA2). It has been used in the primary and secondary prevention of thromboembolic vascular events. Yet, some patients experience recurrent ischemic events despite optimal antiplatelet therapy. This has raised the possibility that these patients may be resistant to aspirin and generated much interest in identification of such patients with laboratory tests of platelet function. Although many studies have demonstrated aspirin resistance in cardiovascular disorders including coronary artery disease, metabolic syndrome , and diabetes by certain tests of aspirin resistance, there are still concerns that these tests have not correlated closely with subsequent recurrent events, and have not reliably identified non-responders to antiplatelet therapy . In addition to the absence of any standardized approach to the diagnosis, there is currently no proven effective treatment for aspirin resistance. Although aspirin resistance has been demonstrated as a possible risk factor for recurrent cardiovascular ischemic events, there is a lack of data correlating aspirin resistance and risk of cerebrovascular ischemic events

Eligibility Criteria:
Inclusion Criteria:

1. At least 7 days of aspirin therapy (acetylsalicylic acid, 100 mg daily) prior to stroke onset
2. Within 24 h of experiencing a new focal or global neurological deficit.
3. Evidence of new or old ischemic infarct on CT brain or magnetic resonance imaging (MRI).
4. With informed consents.
5. Presence or not previous cerebrovascular event as previous history of transient ischemic attack (TIA) before the onset of stroke.

Exclusion Criteria:

1. Patients with other neurological deficits due to stroke mimics or hemorrhagic insult.
2. Patients is subjected to anticoagulant treatment (atrial fibrillation, valve replacement, others).
MRI in Evaluating the Effect of Efaproxiral on the Brain in Patients With Recurrent or Progressive Glioma Enrolled on Clinical Trial NABTT-9806

RATIONALE: Diagnostic procedures, such as MRI, may help doctors learn how efaproxiral works in the brain and help plan the best treatment.

PURPOSE: This clinical trial is using MRI to evaluate the effect of efaproxiral on the brain in patients with recurrent or progressive glioma receiving treatment on clinical trial NABTT-9806.

OBJECTIVES:

* Determine whether efaproxiral has a measurable effect on the brain as shown by T2 and/or T2\* MRI in patients with recurrent or progressive malignant glioma enrolled on NABTT-9806.
* Determine predicted oxygenation changes based on observed T2 MRI changes in these patients.
* Determine the effects of this drug on T2 and T2\* MRI relaxation times of normal areas of the brain in these patients.
* Determine baseline oxygen extraction ratios in tumors of patients treated with this drug.
* Determine whether administration of this drug reveals any new tumor- or non-tumor-related abnormalities on T2 and T2\* MRI in these patients.

OUTLINE: This is an open-label, multicenter, pilot study.

Patients receive efaproxiral and carmustine on clinical trial NABTT-9806. During any one course of treatment on that study, patients undergo MRI before oxygen administration (baseline), before efaproxiral infusion, and then every 5 minutes until 1 hour after efaproxiral and carmustine treatment. Data is evaluated for extent and intensity of T2/T2\* changes and oxygen concentration changes in both abnormal and normal brain.

PROJECTED ACCRUAL: A total of 15-48 patients will be accrued for this study within 12-24 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Recurrent or progressive glioma
* Currently enrolled on clinical trial NABTT-9806

PATIENT CHARACTERISTICS:

* No severe claustrophobia
* No cardiac pacemaker
* No MRI-incompatible metallic implant

PRIOR CONCURRENT THERAPY:

* Not specified
Pharmacokinetics and Safety Assessment of VX-121/Tezacaftor/Deutivacaftor in Participants With Moderate Hepatic Impairment

The purpose of this study is to evaluate the pharmacokinetics (PK) and safety of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in participants with moderate hepatic impairment and in matched healthy participants.

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility Criteria:
Key Inclusion Criteria:

* Cohort 1: Participants with Moderate Hepatic Impairment

  * Participants will satisfy the criteria for moderate hepatic impairment defined as a Child-Pugh total score of 7 to 9 points at the screening visit
  * Participants will have chronic (≥6 months) documented liver disease
* Cohort 2: Matched Healthy Participants

  * Participants will be matched during screening to participants with hepatic impairment for cigarette smoking habit, age, sex, and weight

Key Exclusion Criteria:

* Cohort 1: Participants with Moderate Hepatic Impairment

  * History of febrile illness or other acute illness
  * History of solid organ or bone marrow transplantation
  * History or presence of severe hepatic encephalopathy (Grade \>2)
  * Any condition possibly affecting drug absorption
  * Severe portal hypertension
  * Significant renal dysfunction (creatinine clearance \<50 milliliter per minute \[mL/min\] ) estimated according to the method of Cockcroft and Gault at the screening Visit or Day-1
* Cohort 2: Matched Healthy Participants

  * History of febrile illness or other acute illness
  * Any condition possibly affecting drug absorption

Other protocol defined Inclusion/Exclusion criteria may apply.
Significance of MRD Monitoring in Patients With Potentially Resectable Stage III Non-small Cell Lung Cancer

Stratification of postoperative ctDNA status can effectively assess the risk of recurrence in patients. In addition, the multi-node dynamic monitoring of ctDNA is more effective in predicting the recurrence risk of patients. In this study, EGFR/ALK negative potentially resectable Stage III non-small cell lung cancer were enrolled. Baseline tissues, Peripheral blood samples of patients at baseline puncture tissue, after neoadjuvant therapy, after surgery (if any), after adjuvant therapy, and at multiple nodes during follow-up were collected for 1021-MRD analysis through tumor-informed personalized monitoring MRD test kit. This study aim to explore MRD biomarker in patients with potentially resectable stage III non-small cell lung cancer.

In this prospective study, 65 patients with potentially operable non-small cell lung cancer without driving gene EGFR/ALK mutation in stage III were enrolled in this prospective study. peripheral blood samples from multiple nodes after neoadjuvant therapy, postoperative (if any), adjuvant therapy and follow-up were collected and analyzed by high-throughput sequencing in the target region. Patients were enrolled in the study for 1 year, followed up for 2 years, and the study lasted for 3 years. The patients were followed up for 2 years according to the standard diagnosis and treatment path, with a total of 9 times of follow-up, all of which were 3-month follow-up plan of the standard diagnosis and treatment path, and the follow-up examination was conducted in accordance with clinical standards.

Eligibility Criteria:
Inclusion Criteria:

1. Capable of giving signed informed consent, age ≥ 18 and ≤ 80.
2. patients with stage Ⅲ non-small cell lung cancer confirmed by histology or cytology have potential surgical opportunities.
3. No driving gene EGFR/ALK mutation.
4. PS = 0-1.
5. the treatment process cooperated with the provision of clinicopathological and imaging data needed in the research process, followed up and collected the blood of the clinical efficacy evaluation nodes, and agreed to use the test data for follow-up research and product development.

Exclusion Criteria:

1. patients suffering from other malignant tumors.
2. patients change the treatment regimen before receiving the specified treatment or before the disease progresses.
3. Patients could not cooperate with the study for follow-up according to the defined clinical follow-up period;
4. Patients were unable to accept or provide imaging and other designated therapeutic evaluation means.
HER2-low Unresectable and/or Metastatic Breast Cancer in Russia

Planned study population consists of approximately 3,150 adult patients with HER2-negative (IHC 0, + or IHC2+/ISH-) unresectable or metastatic BC enrolled to the study in order to obtain approximately 2,000 patients with confirmed HER2 low status (IHC1+ or IHC2+/ISH ).


Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed diagnosis of unresectable and/or metastatic BC established between the 1st July 2021 and the 1st July 2022.
* Patients have HER2-negative status (IHC0, IHC1+, IHC2+/ISH-) obtained in the local laboratory.

  -. Patients have an adequate archival tumor sample and slides suitable for reassessment HER2 status\* by the reference laboratory.
* Patients have documented hormonal status (ER, PR) IHC score.
* Age ≥ 18 years at the time of inclusion.
* Patients provided written consent allowing for data and samples to be used in the future and this study would be covered by the consent for future use in accordance with ICH GCP, GPP (Good Pharmacoepidemiology Practices) and local law prior to inclusion in the study. If the patient is deceased, a waiver may be accepted

Exclusion Criteria:

* Patients with previous HER2 positive status in the anamnesis at the diagnosis or after the diagnosis of breast cancer.
* Presence of other malignancies within period since diagnosis until the timepoint of data collection.
* Patients receiving trastuzumab deruxtecan currently or received in anamnesis.
* The participation in any randomised controlled trial within period since diagnosis until end of study.
A Study of Montelukast (MK-0476) Compared With Fluticasone in Pediatric Participants With Chronic Asthma (MK-0476-303)

A study to determine the effects of montelukast (MK-0476) on pediatric participants with chronic asthma compared with fluticasone. The primary hypotheses are that, over 24 weeks of treatment, montelukast will provide at least the same level of asthma control as inhaled fluticasone as measured by the percentage of days without asthma and that, over 24 weeks of treatment, daily administration of montelukast will be safe and well tolerated in children aged 6 months to 5 years with chronic asthma.

This trial was stopped at a time before any participants had actually entered the trial. Based on input from regulatory agencies, it is not necessary to conduct this study; a separate ongoing study was sufficient for regulatory purposes.

This study consists of a 4-week placebo run-in period followed by a 24-week double-blind treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Between 6 months and 5 years, 4 months of age
* Diagnosed with asthma by a doctor
* At least 3 episodes of asthma symptoms within the last 6 months

Exclusion Criteria:

* Active or chronic breathing disease, other than asthma
* Required insertion of a breathing tube for asthma
* Major surgery within the last 4 weeks
* Currently in the hospital
* Allergic to certain drugs, and for children under 2 years of age, apples, applesauce and formula
Toripalimab Plus Stereotactic Body Radiotherapy for HCC With PVTT

To explore the efficacy and safety of toripalimab plus stereotactic body radiotherapy for hepatocellular carcinom with portal vein tumor thrombus.

Programmed Cell Death Protein-1 (PD-1) was effective and tolerable in patients with advanced hepatocellular carcinoma. Additionally, previous studies showed that stereotactic body radiotherapy (SBRT) was effective for hepatocellular carcinoma with portal vein tumor thrombus (PVTT). No study has evaluated the efficacy and safety of toripalimab plus SBRT for hepatocellular carcinoma with PVTT. Thus, the investigators carried out this prospective study to find out it.

Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
* Patients must have at least one tumor lesion that can be accurately measured according to mRECIST criteria
* The normal liver volume in the non-target area was greater than 700ml
* Portal vein tumor thrumbus confirmed in two image techniques
* Eastern Cooperative Oncology Group performance status of 0 to 2
* No Cirrhosis or cirrhotic status of Child-Pugh class A only
* With no previous radiotherapy and immunotherapy
* Not applicable for transarterial chemoembolization, surgical resection, and local ablative therapy.
* The following laboratory parameters:

Platelet count ≥ 75,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/ L Serum albumin ≥ 30 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3 Ability to understand the protocol and to agree to and sign a written informed consent document

Exclusion Criteria:

* Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
* Known history of HIV
* History of organ allograft
* Known or suspected allergy to the investigational agents or any agent given in association with this trial.
* Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
* Evidence of bleeding diathesis.
* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
* Known central nervous system tumors including metastatic brain disease
Trial of Daily Pulse Interleukin-2 With Famotidine in Acute Myelogenous Leukemia

Assess the immunotherapy benefit of interleukin-2 in acute myelogenous leukemia treatment during lymphocyte recovery.

Upon lymphocyte recovery after myeloablative induction standard chemotherapy pulse Interleukin-2 administered

Eligibility Criteria:
Inclusion Criteria:

* Confirmed hematopathology diagnosis of AML receiving marrow suppressive treatment
* Total WBC recovery of 500 mm3 prior to IL-2 treatment
* Platelet count of at least 20,000 mm3 prior to starting IL-2 treatment
* Active infection controlled prior to starting IL-2 treatment
* Stable systolic blood pressure \> 90mm Hg prior to starting IL-2 treatment
* O2 saturation \>90% prior to starting treatment
* Stable cardiopulmonary status prior to starting IL-2 treatment
* Serum creatinine \< or equal to 2.0 mg/dl
* Total bilirubin and AST \<3x upper limits normal

Exclusion Criteria:

* Acute Promyelocytic Leukemia
* Active thrombocytopenic bleeding
* Cardiac ejection fraction below 45%
* Pregnancy and/or lactation
Effectiveness of DN Versus TU Along With Routine PT in Patients With for Chronic Neck Pain RCT

To determine the effectiveness of dry needling and therapeutic ultrasound for the treatment of chronic neck pain


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria will be office workers having pain sensation at neck for at least 4 months
* pain for 3-7 on NRS and with the limited or painful ROM.
* Age of the participants will be 20-35 years.
* Only those individuals will be included who are working in the field for more than 8 months and work for 6-8 hours per day.

Exclusion Criteria:

* The exclusion criteria were any other neurological conditions of cervical vertebra, cervical radiculopathy, any vascular disease, tumors or any other local infection
The Efficacy Of Elonide Nasal Corticosteroids In Managing Allergic Rhinitis

The aim of this clinical study is to compare the efficacy of Elonide Nasal Spray to Nasonex Nasal Spray and Placebo (non-active ingredient) in the management of allergic rhinitis.

There are two hypotheses of this study:

1. Elonide nasal spray is same efficacy to Nasonex nasal spray.
2. Elonide nasal spray is more efficient to placebo.

There are several objectives of the study:

1. To compare the efficacy of Elonide to Nasonex and Placebo in treating allergic rhinitis via Quality of life assessments and nasal airflow improvements.
2. To compare the efficacy of Elonide to Nasonex and Placebo in treating allergic rhinitis via symptomatics improvement.
3. To assess the side effect of Nasal spray given.

Patients who meet the criteria to join the study will be randomized in a double-blind manner (patients and investigators). Patients will be given information about the study and consent form, patients will be randomized to 3 treatment group(Elonide, Nasonex, Placebo). Patients will be evaluated before and after treatment in one month time. Patients will be advised to use the nasal spray twice daily.

Eligibility Criteria:
Inclusion Criteria:

* All adults patients 18 years and above
* Newly diagnosed mild, moderate to severe, intermittent and persistent allergic rhinitis
* Positive skin prick test or serum Immunoglobulin E

Exclusion Criteria:

* Patients who have been on allergic rhinitis treatment
* Below 18 years old
* Patients diagnosed with asthma or immunodeficiency diseases
* Pregnancy
* Other concomitant rhinology disease
* Smokers
* Severe deviated nasal septum
Evaluation of Bone Markers as Diagnostic Tools for Early Detection of Bone Metastases in Patients With High Risk Prostate Cancer

It is the aim of this prospective, single-group, clinical study to assess whether bone parameters can be used as diagnostic tools for early detection of bone metastases in patients with high risk prostate cancer. The usefulness in monitoring zoledronic acid therapy in patients who have developed bone metastases will also be assessed.


Eligibility Criteria:
Inclusion criteria:

* Patients with histologically confirmed diagnosis of prostate cancer who have not yet developed bone metastases
* Prostate cancer patients with a rise in PSA under hormone therapy.

PSA criteria:

* Patients who have undergone prostatectomy: any rise in PSA or
* Patients without prostatectomy: 2 consecutive rises in PSA levels relative to a previous reference value, separated by one month. The first measurement must occur one month after the reference value and must be above the reference value. The second confirmatory measurement taken one month after the first measurement must be greater than the first measurement.
* Previous chemotherapy or radiotherapy must have been performed ≥ 8 weeks prior to study entry.
* Eastern Cooperative Oncology Group (ECOG) score of 0, 1 or 2 (patients that spend less than 50% of time in bed during the day)
* Adequate liver function - serum total bilirubin concentration less than 1.5 x upper limit of normal value
* Age: ≥ 18 years
* Patient has given written informed consent prior to any study-specific procedures. Patients with psychiatric or addictive disorders which prevent them from giving their informed consent must not enter the study.

Exclusion criteria:

* Prior treatment with a bisphosphonate
* Abnormal renal function as evidenced by a calculated creatinine clearance \< 30 ml/minute.
* Corrected (adjusted for serum albumin) serum calcium concentration \< 8.0 mg/dl (2.00 mmol/L) or ≥ 12.0 mg/dl (3.00 mmol/L).
* Patients with clinically symptomatic brain metastases
* History of diseases with influence on bone metabolism such as Paget's disease and primary hyperparathyroidism
* Severe physical or psychological concomitant diseases that might impair compliance with the provisions of the study protocol or that might impair the assessment of drug or patient safety, e.g. clinically significant ascites, cardiac failure, NYHA III or IV, clinically relevant pathologic findings in ECG
* Known hypersensitivity to zoledronic acid or other bisphosphonates
* Use of other investigational drugs 30 days prior to the date of randomization
* Known history or present abuse of alcohol or drugs
* Subjects who, in the opinion of the investigator, are unlikely to cooperate fully during the study
* Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.
* Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)

Other protocol defined inclusion/exclusion criteria may apply.