cyrilzakka/clinical-trials huggingface dataset:
A Safety and Preliminary Efficacy Study of SBT6290 Alone and in Combination With PD-(L)1 Inhibitors in Select Advanced Solid Tumors

This is a first-in-human, open-label, multicenter, dose-escalation and expansion study designed to investigate SBT6290 administered alone and in combination with pembrolizumab in advanced solid tumors associated with Nectin-4 expression.

This is a first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, immunogenicity, and preliminary antitumor activity of SBT6290 administered subcutaneously (SC) as a monotherapy and in combination with pembrolizumab in solid tumors associated with Nectin-4 expression. There are 4 parts to this study:

* Part 1: A dose escalation of SBT6290 monotherapy
* Part 2: Tumor-specific expansion cohorts evaluating SBT6290 monotherapy administered at the recommended phase 2 dose (RP2D) identified in Part 1
* Part 3: A dose escalation of SBT6290 in combination with pembrolizumab
* Part 4: An expansion cohort of SBT6290 in combination with pembrolizumab administered at the RP2D identified in Part 3 for the combination

Eligibility Criteria:
Key Inclusion Criteria:

* Locally advanced or metastatic solid tumors associated associated with Nectin-4 expression (locally advanced or metastatic urothelial carcinoma, TNBC, NSCLC, SCCHN, and HR+/HER2- negative breast cancer)
* Measurable disease per the the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria
* Tumor lesion amenable for biopsy available to submit for retrospective baseline testing of Nectin-4; archived tumor tissue may be acceptable depending upon study Part detailed criteria
* ECOG Performance Status of 0 or 1
* Adequate organ and marrow function Note: Other protocol-defined inclusion/exclusion criteria may apply.

Key Exclusion Criteria:

* History of allergic reactions to certain components of study treatments
* Untreated brain metastases
* Currently active (or history of) autoimmune disease
* Taking the equivalent of \>10 mg / day of prednisone
* Uncontrolled or clinically significant interstitial lung disease (ILD)
* History of ongoing, uncontrolled, symptomatic eye disorders requiring intervention or associated with marked visual field defects or limiting age-appropriate instrumental activities of daily living
* HIV infection, active hepatitis B or hepatitis C infection Note: Other protocol-defined inclusion/exclusion criteria may apply.
HEAVEN CRITERIA vs Modified LEMON Score for Predicting Difficult Intubation

Emergency tracheal intubation is a lifesaving procedure frequently performed on critically ill and injured patients in the emergency department (ED). Emergency intubations are more difficult than elective intubations in the operating room setting because of the sicker patient population with a limited physiologic reserve and less controlled setting in the ED. Indeed, the proportion of difficult intubation ranges from 10% to 27% in the ED setting , whereas the rate ranges from 1% to 9% of elective intubation in the anaesthesia setting. Because emerging evidence demonstrates that repeated intubation attempts are associated with an increased risk of adverse events, early recognition of difficulty intubation with a systematic use of rescue methods in ED patients is critical. The commonest airway prediction tool is the LEMON score. In the modified LEMON score "Mallampati" was excluded as it was not a pragmatic assessment in the ED.

Existing difficult airway prediction tools were derived in the elective surgery environment and may not be applicable to emergency airway management. LEMON criteria was designed for preoperative clinical setting.

Hence in this study we are observing if HEAVEN (H- Hypoxemia E - extremes of age A - anatomical abnormalities V - vomit/ blood / fluid E - Exsanguination/anaemia N - neck mobility issues) is a better tool for predicting difficult intubatio.


Eligibility Criteria:
Inclusion Criteria:

* 1. All patients who undergo an endotracheal intubation in the emergency medicine department and 2. who legally give consent for the study or relatives give consent

Exclusion Criteria:

* Patients not consenting for the study or · Patients in cardio respiratory arrest
Nellcor Bedside Respiratory Patient Monitoring System With Respiration Rate Version 2.0

To validate the Respiration Rate Version 2.0 algorithm, housed in the Nellcor Bedside Respiratory Patient Monitoring System, for performance during motion conditions.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female subjects 18 years or older (inclusive)
* Subject is able to participate for the duration of the study
* Subject is willing to sign an informed consent

Exclusion Criteria:

* Subject with abnormalities that may prevent proper application of the devices
* Physiologic abnormalities that prevent proper application of pulse oximetry sensor
* Severe contact allergies that cause a reaction to standard adhesive materials such as those fund in medical sensors and electrodes
* Subjects with significant arrhythmia, as determined by subject self-report during screening and I/E criteria assessment at study start. (Three events of irregularities in radial pulse with thirty seconds).
Study of MRTX1133 in Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation

A Phase 1/2 study of MRTX1133 in solid tumors harboring a KRAS G12D mutation.

This first-in-human clinical trial will begin with an exploration of MRTX1133 dose and regimen. As potentially viable regimens are identified, Phase 1b expansion cohorts may be implemented to ensure collection of sufficient safety and PK information, and early evidence of clinical activity are available to recommend Phase 2 regimens. In Phase 2, separate cohorts of patients by histological diagnosis and/or baseline characteristics will be evaluated for the clinical activity and efficacy of MRTX1133.

This study was terminated prior to phase 2 initiating. Only phase 1 of the study was conducted.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of a solid tumor malignancy harboring KRAS G12D mutation in tumor tissue or ctDNA.
* Unresectable or metastatic disease.
* Patients must have received standard therapies appropriate for their tumor type and stage; first-line treatment for PDAC for certain cohorts.
* Presence of tumor lesions to be evaluated per RECIST v1.1:

  1. in the Phase 1 dose escalation cohorts, patients must have measurable or evaluable disease.
  2. in the Phase 1b and Phase 2 cohorts, patients must have measurable disease.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate organ function.
* Age ≥ 18 years

Exclusion Criteria:

* Active brain metastases or carcinomatous meningitis.
* Prior treatment with a KRAS G12D inhibitor (Phase 1b \& Phase 2 only).
* History of significant hemoptysis or hemorrhage within 4 weeks of the first dose of study treatment.
* History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter absorption of study treatment or result in inability to swallow oral medications.
* History of malignant small bowel obstruction.
* Cardiac abnormalities.
Esophageal Pressure Measurements During One-lung Ventilation

The investigators will assess the feasibility and validity of esophageal pressure measurements during one-lung ventilation in the lateral position for surgery by comparing to lung collapse estimated from electrical impedance tomography during a PEEP trial.

In this prospective cohort study, the investigators will assess the feasibility of esophageal pressure measurements during general anesthesia with one-lung ventilation in patients undergoing non-cardiac intrathoracic surgery, which is typically conducted in the lateral position. The investigators will measure esophageal pressure with an esophageal balloon catheter. The investigators will compare esophageal pressure measurements to lung collapse estimated by Electrical Impedance Tomography (EIT).

Patients will be equipped with the EIT belt before induction of anesthesia, and a one-minute EIT recording during spontaneous breathing will be conducted. Anesthesia will be induced as to institutional standards and upon the discretion of the attending anesthesiologist. After placement of a double-lumen endotracheal tube, the esophageal balloon catheter will be placed.

* After placement of the esophageal catheter, esophageal pressure, transpulmonary pressure, airway pressure and flow and EIT signal will be recorded ("baseline").
* When the patient has been positioned for surgery (typically in the lateral position), a second recording of the above parameters is conducted ("lateral"). One-lung ventilation will then be initiated and a third measurement ("OLV") is made.
* During the third measurement, a decremental positive end-expiratory pressure trial will be conducted to correlate the measured esophageal pressure to the positive end-expiratory pressure where lung collapse is detected from EIT.
* Before surgery, the EIT belt is opened and removed from the surgical field to avoid interference.
* If feasible, when surgery is finished, before reversal of neuromuscular blockade and extubation, a final recording of EIT, esophageal pressure, transpulmonary pressure, airway pressure and flow will be conducted.

Eligibility Criteria:
Inclusion Criteria:

* adult patients undergoing non-cardiac surgery with OLV

Exclusion Criteria:

* COPD
* Active respiratory infection
* Prior lung resection
* Prior esophageal/gastric surgery
* Esophageal varices
* Patients under effective anticoagulation at time of surgery
* Pacemaker/ICD
* Pregnancy
* Inability to give written informed consent
Comparison Between Urocortin 2 and Brain Type Natriuretic Peptide

1. Evaluation of the role of serum urocortin 2 levels in acute decompensated HF patients and their association with clinical and echocardiographic findings.
2. Assessment of the clinical utility of urocortin 2 in monitoring AHF patients.
3. Comparison between urocortin 2 and BNP as a biomarker in AHF patients

Heart failure (HF) is a clinical syndrome with symptoms and/or signs caused by a structural and/ or functional cardiac abnormality and corroborated by elevated natriuretic peptide levels and/or objective evidence of pulmonary or systemic congestion. (1) .The pathophysiology of HF is a complex interplay of genetic and multiple molecular mechanisms (from inﬂammation to hormonal pathways) performing in the composite network of the cardiovascular system environment. (2).

Monitoring of biomarkers in HF can be used to make an initial diagnosis, to aid in prognostic stratification, and to identify a patient's response to therapeutic intervention. (3).

Natriuretic peptide (NP) concentrations are quantitative plasma biomarkers for the presence and severity of haemo-dynamic cardiac stress and heart failure. (4). That facilitate renal filtration and sodium excretion whilst suppressing the vasoconstrictor sodium, retaining Renin angiotensin aldosterone system and exerting a tonic anti-trophic effect. (5). But the natriuretic peptide levels are significantly affected by weight, the NT- proBNP in obese subjects is much lower than normal weight subjects. (6). Other factors that affect BNP levels including gender, age and renal disease

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with acute decompensated heart failure.

Exclusion Criteria:

* Acute coronary syndrome or stroke in the past 3 months.
* Severe chronic kidney disease.
* Severe valve disease.
Measurement of the Optic Nerve Sheath Diameter

This study is a prospective assessment of the accuracy of ocular ultrasound as a tool to measure the diameter of the optic nerve sheath and the eyeball transverse diameter in healthy adult patients presenting to the Emergency Department and have confirmatory imaging of the optic nerve as part of their clinical care.

This will be a prospective evaluation of accuracy of microconvex and linear transducers for ultrasound measurements of the ONSD and the ETD. Study population will be adult patients that present to Cleveland Clinic Akron General Emergency Department between July 1, 2022 and July 31 April 1, 2023. Patients will be identified on the Emergency Medicine Department tracking board. Patients, once identified as meeting inclusion criteria will be asked to participate in this study and full written consent will be required. All participants will have identical procedures and there will be no groups.

Eligibility Criteria:
Inclusion criteria:

* 18 years of age and older, and;
* Present to Cleveland Clinic Akron General's ED (Main)
* Have CT head and/or ocular ordered as a part of clinical care that is read as normal or no acute disease (confirmatory imaging), and;
* Agree to and provide written consent for participation.

Exclusion criteria:

* Acute ocular pathology
* Abnormal brain and/or ocular CT
* History of increased intracranial pressure or optic nerve disease
* Not medically stable
* Pregnant or incarcerated
* Unable to consent.
Manual Therapy in Patients With Asthma

Physical therapists have traditionally included various forms of manual therapy among the therapeutic approaches to respiratory conditions. The aim of this study was to evaluate the effect of diaphragmatic stretching technique on pulmonary ventilation, rig bage excursion and spirometric values in patients diagnosed with asthma.

Asthma is a chronic lung disease involving an inflammation and a narrowing of the airways. Asthma causes wheezing, chest tightness, shortness of breath, and coughing.

A variety of manual therapies are commonly used to treat patients with asthma. There is a need to conduct studies in order to examine the effects of manual therapies on clinically relevant outcomes. Techniques aim to increase movement in the rib cage and the spine to try and improve the working of the lungs and circulation.

Eligibility Criteria:
Inclusion Criteria:

* Age ranging between 18 and 45 years.
* Diagnosis of asthma.
* No exacerbations during last month.

Exclusion Criteria:

* History of spine surgery.
* Diabetes, neurological or a cardiovascular disease.
* Spine deformities and use of orthopedic devices.
Value of MRI CSF Flowmetry in Assessment of Grey Zone Hydrocephalic Patients

To evaluate accuracy of (MRI) cerebrospinal fluid flowmetry after shunt operation in patients with borderline (grey zone) hydrocephalus.

Hydrocephalus could be defined as disturbance of formation, flow or absorption of CSF. We encounter some challenging cases with intermittent non specific symptoms as delayed milestones and headache with concomitant imaging showing dilated ventricular system, so we find ourselves hesitating to take the decision of surgical intervention to put shunt or not, therefore MRI CSF flowmetry gives us a chance to overcome this problem. Phase contrast MR imaging is a rapid, simple and non-invasive technique which is sensitive to even small CSF flows, and can be used to evaluate CSF flow both qualitatively and quantitatively.

CSF flow measurement at the suspected level of obstruction gives reliable and reproducible results for more accurate diagnosis and can be used to guide therapeutic decisions in a more reliable manner, and follow up post treatment outcome.

With the CT and magnetic resonance imaging (MRI) techniques, it is possible to localize with accuracy the exact site of blockage of flow to CSF. Hence classification is as follows: The hydrocephalus may be due to 1) overproduction of CSF 2) obstructive 3) absorption defect. Depending on the exact aetiology, a secondary classification could be added under the following headings: 1) congenital, 2) acquired, eg; traumatic inflammatory, neoplastic, and degenerative . Bypassing the site of obstruction to CSF flow by diverting the CSF from ventricular cavity to a site where it is readily absorbed is the basic principle underlying the treatment of hydrocephalus. Extensive range of complications has been reported for shunting for hydrocephalus. They could be classified as mechanical or flow-related complications as CSF over drainage leading to subdural hematoma, subdural collections, low-pressure headaches cranial deformity, and asymmetrical drainage can lead to trapping or isolation of a part of a ventricular system. The slit ventricular syndrome is a complication related to absorption. Besides, ascites, loculations, hydrocele, perforation of the stomach, large and small bowel are also described. The success rates of shunt operation for hydrocephalus depend on the age of the patient and the reason why the shunt is needed. Generally, there is around a 50% failure rate for ventriculoperitoneal shunts.

Eligibility Criteria:
Inclusion Criteria:

Patients with borderline hydrocephalus

* Clinically:suspicious and non specific symptoms as

  * Headache
  * Macrocranium
  * Vomiting
  * Gait instability
  * Dementia
  * Urine incontinence.
  * delayed milestone.
* Radiologicaly: dilated ventricular system.

Exclusion Criteria:

* Documented or clinically and radiologically evident cases of hydrocephalus
* Patients known to have contraindications for MRI, e.g. an implanted magnetic device, pacemakers or claustrophobia.
Monitoring of MDRO Dynamics and Resistance Mechanisms in a University Hospital Network

Survey on the prevalence of MDRO to monitor the import of MDRO from the community. Rectal swabs will be taken and cultivated. Survey on community-onset and nosocomial bloodstream infections will be documented and strains will be isolated. For each BSI a clinical data set will be obtained (e.g. patient age, gender, date of hospitalization, antibiotic therapy). Genetic analysis of MDRO from the prevalence and BSI study. In a subset of patients the microbiome-resistome interactome will be analysed in more detail. Furthermore, the impact of infection control measures due to the Covid-19 pandemic on nosocomial BSI will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years old
* informed consent
* inpatient

Exclusion Criteria:

* less than 18 years old
* Not capable of giving informed consent
* outpatient
Deep Posterior Post Gluteal Compartment Block in Total Hip Arthroplasty: Feasability and Safety

This study aims to evaluate the effectiveness of a posterior hip capsule block performed in addition to a PENG (Pericapsular Nerve Group) block for patients undergoing hip arthroplasty. The primary objective is to assess whether this combined approach provides enhanced perioperative analgesia compared to the standard analgesic protocol or the PENG block alone. Secondary outcomes will focus on opioid consumption, functional recovery, and any potential complications. By targeting both the anterior and posterior innervation pathways around the hip joint, this combined technique could improve patient comfort, decrease opioid requirements, and potentially expedite rehabilitation after hip arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

All adults with total hip arthroplasty

-

Exclusion Criteria:

* Contraindication to regional anesthesia
* allergy
* refusal of the injection
Clinical Efficacy of Intravenous Iclaprim Versus Vancomycin in the Treatment of Hospital-Acquired, Ventilator-Associated, or Health-Care-Associated Pneumonia

The purpose of this study is to compare the clinical cure rates of two dosing regimens of iclaprim with vancomycin (every 12 hours \[q12h\]) in the treatment of patients with hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), or health-care-associated pneumonia (HCAP) suspected or confirmed to be due to Gram-positive pathogens.


Eligibility Criteria:
Inclusion Criteria:

* Suspected or confirmed acute bacterial pneumonia due to Gram-positive pathogens in one of the following subgroups:

  * hospital-acquired pneumonia (HAP), i.e., pneumonia that occurs 48 hours or more after admission, which was not incubating at the time of admission; or
  * ventilator-associated pneumonia (VAP), i.e., pneumonia that arises more than 48 hours after endotracheal intubation; or
  * health-care-associated pneumonia (HCAP), i.e., pneumonia diagnosed within 48 hours of hospital admission, in a patient who fulfills at least one of the following criteria:

    1. hospitalization for at least two days within 90 days of the current infection,
    2. residence in a nursing home or long-term care facility,
    3. recipient of intravenous antibiotic therapy, chemotherapy, or wound care within 30 days of the current infection

Exclusion Criteria:

* Acute Physiology and Chronic Health Enquiry (APACHE) II score \< 8 or ≥ 25.
* Pneumonia not requiring empiric or targeted treatment effective against Gram-positive pathogens.
* Pulmonary infection due to Gram-positive organisms known to be resistant to either study medication prior to study entry.
Electrical Stimulation and Vaginal Palpation in Pelvic Floor Muscles Awareness

The purpose of this study is to evaluate the effectiveness of transvaginal electrical stimulation, vaginal palpation, and vaginal palpation associated with posterior pelvic tilt and contraction of accessory muscles in the acquisition of ability to contract the pelvic floor muscles (PFM), as well as to evaluate the sexual function of women studied.

Many women does not know to contract the PFM voluntarily favoring the development of disorders such as urinary and fecal incontinence, pelvic organ prolapse and sexual disorders. However there are no studies in the literature that address the application of therapeutic resources available to improve the PFM awareness. The objective of this study is to evaluate the effectiveness of transvaginal electrical stimulation, vaginal palpation, vaginal palpation associated with posterior pelvic tilt and contraction of accessory muscles in the acquisition of ability to contract the PFM, as well as to evaluate the sexual function of women studied. One hundred twenty women with PFM function graded 0 and 1 measured by Oxford Modified Scale will be submitted at random to physical therapy with transvaginal electrical stimulation, vaginal palpation, vaginal palpation associated with posterior pelvic tilt and contraction of accessory muscles (glutes and hip adductors) and the control group who receive verbal instructions related to the pelvic floor and its contraction. For the evaluation of the sexual function will be applied the Female Sexual Function Index (FSFI).

The patients will be assessed by vaginal palpation, perineometry and surface electromyography before and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

Women with age greater than or equal 18 years; Women with pelvic floor muscle function graded 0 and 1 measured by Oxford Modified Scale; Women who voluntarily consente to participate in research.

Exclusion Criteria:

Women with associated neurological pathologies; Women with symptoms of vaginal or urinary tract infection; Women with pelvic organs prolapse graded greater than 2; Pregnancy suspected or confirmed; Cognitive deficit that impedes or impair the procedure.