cyrilzakka/clinical-trials huggingface dataset:
Effect of Additional Nebulized Amikacin in Ventilator-Associated Pneumonia Caused by Gram Negative Bacteria

The purpose of this study is to determine the cure rate from ventilator-associated pneumonia (VAP) caused by Gram negative bacteria when administering add on nebulized amikacin to intravenous antibiotics compared to intravenous antibiotics alone.

After inclusion, the patients are randomized into two groups: nebulized amikacin plus intravenous antibiotic(s) or nebulized placebo plus intravenous antibiotic(s). The dose of nebulized amikacin is 400 mg every 12 hours for 10 days. The patients are followed up on day 3, 7, 10, and 28 for safety and efficacy. The estimate sample size is 84 subjects base on previous study of cure rate in VAP and the authors expected that nebulized amikacin can improve cure rate in VAP subjects for 30% when compared with intravenous antibiotic(s) alone with power of 80% at level of significance 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Age \>/= 18 years
* On mechanical ventilator more than 7 days
* VAP diagnosis inclusion criteria:

  1. new/progressive infiltration of chest radiography
  2. 2/3 of the following: 1) fever 2) purulent sputum 3) Wbc \> 12,000 cell/mm3 or \< 4,000 cell/mm3
* Evidence of gram negative bacilli from sputum gram stain or previous sputum culture within 1 week

Exclusion Criteria:

* History of amikacin allergy
* GFR \< 30 mL/min except dialytic patients
* Immunocompromised host: HIV CD4 \< 200 cells/mm3, leukemia, lymphoma, received chemotherapy within 3 weeks, Absolute neutrophil count \< 500/mm3
* Severe ARDS (P/F ratio \< 100)
* Endobronchial obstruction:endobronchial mass, endobronchial stenosis
* Atelectasis
* Severe bronchospasm
* Lung abscess
* Complicated parapneumonic effusion/ Empyema
* Chest trauma
* Uncontrolled extrapulmonary infection(s)
* Received intravenous antibiotic(s) more than 48 hours
* Pregnancy/ Lactation
Effects of Pleural Effusion Drainage on Respiratory System Mechanics

The effects of pleural drainage on lung mechanics are unknown. Insertion of esophageal balloon will allow us to measure and assess pleural pressure, and thus assess any possible effects of pleural fluid drainage may have on lung mechanics.

Esophageal balloon will be inserted prior to pleural fluid drainage.

Eligibility Criteria:
Inclusion Criteria:

* Mechanically ventilated patients with significant pleural fluid documented by CT scan or US.who are candidates for pleural fluid drainage.

Exclusion Criteria:

* Patients with any of the following were excluded from the study. Previous lung or chest wall surgery, previous esophageal surgery, known Achalasia or any other esophageal motility or spasm disorder, presence of chest thoracostomy tube, and any significant chest wall abnormality such as kyphoskoliosis.
Patient and Provider Initiated Survivorship Care Planning

Objective: to describe and compare the implementation of two cancer survivorship care tools: (1) 'My Care Plan': a patient-initiated tool and (2) 'Survivorship Care Plan Builder': a provider-initiated tool. The results of this study will be used to (1) provide an initial assessment of the two survivorship care planning tools and (2) inform the design and conduct of a larger study.

Background/Rationale: In a 2005 report 'From Cancer Patient to Cancer Survivor: Lost in Transition', the Institute of Medicine recommended that cancer patients completing treatment receive a summary of the care received and a plan outlining follow-up care needs. Taken together these materials are referred to as a 'Survivorship Care Plan', or SCPs. Based on this recommendation from the IOM, a number of organizations developed survivorship care plan templates. Two of these templates, 'Survivorship Care Plan Builder' and 'My Care Plan,' were developed by Journey Forward, a collaboration among the National Coalition for Cancer Survivorship, UCLA Cancer Survivorship Center, Oncology Nursing Society, WellPoint, Inc., and Genentech (http://journeyforward.org/). These tools are available free of charge to those wishing to use them. As the time and effort required to complete SCP documents have been found to be barriers to implementation, this study aims to explore the use of these two tools.

Research Questions:

1. What processes are undertaken to implement survivorship care planning?

   * How do these processes differ between the patient-initiated My Care Plan and provider-initiated Survivorship Care Plan Builder?
2. What is the feasibility of implementing survivorship care planning?

   * Does the feasibility differ between the patient-initiated My Care Plan and provider-initiated Survivorship Care Plan Builder?
3. What is the value of survivorship care planning to both patients and providers?

   * Does the value differ between the patient-initiated My Care Plan and provider-initiated Survivorship Care Plan Builder?

Study Design: This is a pilot randomized study. Cancer patients completing acute treatment with a participating provider will be randomized to either the patient-initiated My Care Plan tool or provider-initiated Survivorship Care Plan Builder. The investigators will describe and compare how each tool is implemented in practice, the feasibility of completing each tool, and the value of the tools to patients and providers. The study will use quantitative and qualitative measures of implementation, feasibility, and value.

Eligibility Criteria:
Inclusion Criteria:

1. Have you diagnosed with non-metastatic (i.e., stages I - III) cancer (non-melanoma skin cancer)
2. Have you completed acute treatment with intent to cure within the past 2 months (ongoing long-term maintenance therapy such as adjuvant hormonal therapy is allowed)
3. What clinician primarily managed your cancer treatment? (must be a participating Sibley or Suburban clinician)

Exclusion Criteria:

1. Do you show any evidence of disease?
Study of Vaginal Dilator Use After Pelvic Radiotherapy

Patient will have radiation to treat the cancer. This treatment can make the vagina both narrower and shorter. That can cause two problems. It can make it harder for the doctor to do a pelvic exam during a follow-up visits. And, it can make sexual intercourse uncomfortable.

We tell women to use a vaginal dilator after radiation to the pelvis. This is standard education. We do not routinely ask women how they do with it. We are doing this study to see if using the dilator as we instruct will help the vagina stretch. The patient will have an examine of the vagina before the start of radiation. We will see what size dilator can fit. The goal of this study is to have the patient be able to use that size dilator within six months after radiation.


Eligibility Criteria:
Inclusion Criteria:

* Female with cervical, endometrial, rectal or anal cancer
* Scheduled to begin one of the following treatments at MSKCC:
* Definitive external beam radiation therapy
* Preoperative external beam radiation therapy of followed by surgery
* Postoperative external beam radiation therapy
* Definitive external beam radiation therapy with intracavitary brachytherapy (tandem and ring or Syed)± surgery
* Postoperative intravaginal brachytherapy (once every two weeks times three)
* ≥ or = to 21 years of age

Exclusion Criteria:

* Women with cervical, endometrial, rectal or anal cancer who are/have:
* Unable to speak and write English so that it would prohibit them from full participation in the study. Patient education, instruction and questionnaire are validated in English.
* Mental or physical handicaps that would prohibit them from full participation in the study.
* Prior radiation to the pelvis.
* Evidence of metastatic disease.
Montelukast in Very Low Birthweight Infants

The purpose of this study is to determine the pharmacokinetics (PK) of montelukast (Singulair) in very low birth weight (VLBW) infants at risk for developing bronchopulmonary dysplasia (the need for supplemental oxygen). The investigators' long-term hypothesis is that inhibition of leukotriene signaling in the VLBW preterm lung will decrease inflammation, remodeling and the incidence of bronchopulmonary dysplasia (BPD).

This study proposal will determine the pharmacokinetics (PK) of montelukast (cysteinyl leukotriene receptor-1 or CysLT1 inhibitor) in very low birth weight (VLBW) infants between 500 - 1500g birth weight at risk for developing bronchopulmonary dysplasia (BPD). Montelukast (Singulair) is a FDA approved specific CysLT1 antagonist widely used clinically in the prophylaxis of asthma in children older than 12 months of age and blocks leukotriene signaling in the lung. BPD shares some pathogenic mechanisms with asthma, however Cysteinyl LT receptor blockade has not been studied in preterm infants. Montelukast is metabolized by the cytochrome P450 system which is immature in the preterm infant and hence the need for this study. The investigators' long-term hypothesis is that inhibition of leukotriene signaling in the VLBW preterm lung will decrease inflammation, remodeling and the incidence of BPD. The data will be used to design future efficacy trials of Montelukast in the prevention of bronchopulmonary dysplasia.

Eligibility Criteria:
Inclusion Criteria:

* VLBW infants between 500 - 1500 gm birth-weight born at Good Samaritan Hospital, Cincinnati, tolerating oral feeds equal to or more than 75 ml/kg/day and older than 7 days

Exclusion Criteria:

* Infants diagnosed with congenital malformations.
* Infants with an acute life threatening illness.
* Grade III or IV intra-ventricular hemorrhage.
* Patent ductus arteriosus being treated with indomethacin.
* Oral feedings are contra-indicated.
* Parents refuse consent.
* Attending physician does not wish the infant to be enrolled in the study.
* Infants with known hepatitis or HIV.
* Infants enrolled in any study using an investigational drug.
Perioperative Analgesic Effect of Two Different Volumes of Local Anesthetic Solution in Erector Spinae Plane Block in Patients Undergoing Modified Radical Mastectomy

Comparing the perioperative analgesic effect of two different volumes of local anesthetic solution in erector spinae plane block in patients undergoing modified radical mastectomy. A randomized comparative study.

Breast cancer is the most common malignancy among females with incidence of about 2.1 million women each year. Modified Radical Mastectomy (MRM) is one of the main surgical treatments of breast cancer.

Pain can be severe enough to cause long-term disabilities and interfere with sleep and performance of daily activities . Multiple regional techniques have been developed in recent years for postoperative analgesia of breast surgery inkling erector spinae plane block (ESPB) aiming to be effective and associated with less complications when compared to the gold standard techniques (thoracic epidural analgesia or paravertebral block). Ultrasound guided erector spinae plane block (ESPB) was described in 2016 as a novel regional anesthetic technique for acute and chronic thoracic pain, it has been used as a regional anesthetic technique for breast surgery based on case reports and case series. It is a paraspinal fascial plane block that involves injection of local anesthetic deep in the erector spinae muscle and superficial to the tips of the thoracic transverse processes. The site of injection is distant from the pleura, major blood vessels, and spinal cord.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 60 years.
* Genders eligible for study: female sex.
* American Society of Anesthesiologists (ASA) I-II.
* Undergoing modified radical mastectomy.
* Body mass index (BMI) from 18.5 to 30 kg.

Exclusion Criteria:

* Patient refusal.
* Known allergy to local anesthetics .
* Bleeding disorders; platelets count \<50,000 ,prothrombin concentration \< 60% or any coagulopathy disorder.
* Use of any anti-coagulants .
* Inability to provide informed consent.
* Neurological disorders.
* Patient with psychiatric disorders.
Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)

The purpose of this study is to evaluate the safety and efficacy of Epratuzumab with standard treatments for patients with SLE.


Eligibility Criteria:
Inclusion Criteria:

* +ANA at screening
* BILAG Index B Level Activity in at least 2 body systems/organs
* Has SLE by ACR revised criteria (meets,\<4 criteria)

Exclusion Criteria:

* Active Severe Lupus as defined by BILAG Index Level A in any body system or organ.
* Allergy to human antibodies or Murine.
Comparison of the Effects of Crystalloid Cardioplegia and HTK Solution for Postoperative Troponin-I and CK-MB Levels After Pediatric Cardiac Surgery

The purpose of this study is to compare two different cardioplegia solutions effect on postoperative Troponin-I and CK-MB levels after pediatric cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective pediatric cardiac surgery
* Patients written informed consent for study participation

Exclusion Criteria:

* redo surgery
* allergy to study drugs
* unstable blood pressure before cardiac surgery
Preoperative Hip Knee Anxiety Sleep Study

This study is about assessing the impact of reading previous patients' stories related to their hip or knee replacement surgery on patients' preoperative anxiety and sleep. This provision of previous patients' stories is part of an ongoing perioperative QI project in the regional anesthesiology division.

This will be a pre-post experimental design study. The pre-intervention group of 80 hip or knee replacement surgery patients will receive the Amsterdam Preoperative Anxiety and Information Scale (APAIS) and Pittsburgh Sleep Quality Index (PSQI) in Preop Holding prior to having their block for their surgery. The block resident will give and collect the scale and inventory to patients. Patients are given these surveys as part of a quality improvement initiative, independently of this study. The survey data will be entered into the secure electronic research database. Following this, the post-intervention group of 80 patients will be given copies of previous patients' stories at their last visit to the surgeon's office prior to their surgery. These stories will be administered to all hip and knee surgery patients as part of the new standard of care due to a perioperative QI initiative, independently of this study taking place. These subjects will also receive the APAIS and PSQI for assessment in Preop Holding prior to their block for surgery, as part of the new standard of care. A third party broker will then de-identify the survey data and provide it to the research team for analysis. A two-sided independent t-test will be performed to evaluate the differences in anxiety and sleep scores between the pre- and post-intervention groups.

Eligibility Criteria:
Inclusion Criteria:

* Planned to undergo a hip or knee replacement surgery at Henry Ford Hospital

Exclusion Criteria:

* Diagnoses involving sleep disturbance or psychiatric anxiety
Roll-Over Protocol To Provide Atv And/Or Truvada For Extended Access

The purpose of this study is to provide atazanavir or tenofovir-emtricitabine to HIV-infected subjects who have completed atazanavir or tenofovir-emtricitabine therapy on a previous BMS sponsored clinical trial and to collect long-term safety information on the treated population.

Provide study drug for patients rolling off BMS ATV clinical trials in countries where these medications are not commercially available.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must provide written informed consent
* Currently receiving atazanavir (unboosted or boosted with 100 mg ritonavir QD)and/or tenofovir-emtricitabine at time of screening and viral load is

  ≤ 10,000 copies/mL while on therapy
* Subjects who are receiving investigational antiretroviral agents through Expanded Access Programs will be allowed to participate following discussion and approval by the BMS Medical Monitor
* ≥ 16 years of age (or minimum age as determined by local regulatory or as legal requirements dictate)
* Both females of child-bearing potential and males must utilize effective barrier contraception to reduce transmission of sexually transmitted diseases, including HIV. Other contraception in addition to barrier methods are permitted, however interactions between atazanavir and oral contraceptives have not been studied

Exclusion Criteria:

* WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study
* WOCBP using a prohibited contraceptive method (no contraceptive methods prohibited in this study. However, caution is warranted with coadministration of oral contraceptives)
* Women who are pregnant or breastfeeding
* Women with a positive pregnancy test on enrollment or prior to study drug administration, with the exception of women rolling over from AI424182, who may still have a positive β-HCG test at the time of enrollment
* All subjects previously discontinued from an atazanavir study for any reason
* Active alcohol or substance abuse sufficient, in the Investigator's opinion, to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis or chemical hepatitis
* Any other clinical conditions or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for study, or unable to comply with the dosing requirements
* Any of the following laboratory values:
* a) Serum creatinine ≥ 1.5 times the upper limit of normal,
* b) Liver enzymes (AST, ALT) ≥ 5 times the upper limit of normal,
* Hypersensitivity to any component of the formulation of study drug
* Refer to Section 6.4.1 which details all prohibited therapies
* Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study
A Study of Eloralintide (LY3841136) and Eloralintide With Tirzepatide in Participants With Overweight or Obesity

The purpose of this study is to evaluate how well eloralintide and eloralintide with tirzepatide is tolerated and what side effects may occur in participants with overweight or obesity. The study drug will be administered subcutaneously (SC) (under the skin). Blood tests will be performed to check how much eloralintide and eloralintide with tirzepatide get into the bloodstream and how long it takes the body to eliminate it.

There will be 6 cohorts. The study will last up to approximately 26 weeks, excluding screening for Cohorts A and B, 11 weeks for Cohorts C and D, and 12 weeks for Cohorts E and F.


Eligibility Criteria:
Inclusion Criteria:

* Have safety laboratory test results within normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator. Participants with a history of thyroid disease or on thyroid medication will need to be biochemically euthyroid as assessed by measuring thyroid stimulating hormone at screening
* Have a body mass index (BMI) within the range of 27.0 to 40.0 kilogram per square meter (kg/m²), inclusive
* Have had a stable weight for the 3 months prior to screening and enrollment, that is, less than 5% body weight change

Exclusion Criteria:

* Have known allergies to related compounds of eloralintide or tirzepatide, or any of the components of the formulations
* Have significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data
* Have been diagnosed with Type 1 or Type 2 diabetes mellitus, or have glycated hemoglobin greater than or equal to 6.5% or 48 millimole per mole (mmol/mol)
* Have a history of any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
* Have a history or presence of a gastrointestinal (GI) disorder or previous surgery that impacts gastric emptying for example, gastric bypass surgery or pyloric stenosis
* Have obesity induced by other endocrinologic disorders for example, Cushing syndrome, or diagnosed monogenetic or syndromic forms of obesity for example, Melanocortin 4 Receptor deficiency or Prader Willi syndrome
* Have a history of hypocalcemia or hypercalcemia, or abnormal laboratory values for calcium or serum phosphorus
* Have a medical history or current evidence of clinically significant cardiac condition, as per the investigator, including:

  * second or third degree heart block
  * sick sinus syndrome
  * peripheral arterial circulatory disorders
  * valvular disease
  * cardiomyopathy, or
  * other clinically significant cardiac condition
* Have taken approved or investigational medication for weight loss, including GLP-1 RAs, within the previous 3 months of study screening
* Intend to use any weight loss medications during study participation
Efficacy of Intra-articular Injections for the Treatment of Primary Glenohumeral Osteoarthritis(GHOA)

The purpose of this study is to compare the efficacy of intra-articular corticosteroid injections versus platelet-rich plasma injections for non-operative treatment of primary glenohumeral osteoarthritis. The efficacy of intra-articular injections, outside of hyaluronic acid, for the treatment of glenohumeral OA is not known, yet these treatments are commonly used with hopes of providing patients with symptomatic relief that can hopefully delay or prevent the need for shoulder arthroplasty. This study will help elucidate the therapeutic benefit of corticosteroid and Platelet Rich Plasma (PRP) injections in this patient population.


Eligibility Criteria:
Inclusion Criteria:

* Patient ≥18y.o. of age
* Primary glenohumeral arthritis (bone on bone or near bone on bone) that has been previously diagnosed on radiographs and clinical evaluation.
* Baseline pain level of VAS \>4

Exclusion Criteria:

* Secondary causes of arthritis (i.e. septic arthritis, rheumatoid arthritis, rotator cuff arthropathy, post-traumatic arthritis)
* Ipsilateral shoulder surgery within 1 year
* Any glenohumeral joint injection within 3 months
* Allergy to lidocaine
* Known pregnancy
* Workers compensation case regarding shoulder