cyrilzakka/clinical-trials huggingface dataset:
Monitoring of Postoperative Residual Neuromuscular Blockade in Laparoscopic Surgery

Compare the reversal effect of neostigmine and sugammadex using quantitative neuromuscular monitoring

At the end of surgery, decide the dosage of reversal referring to quantitative neuromuscular monitoring value (TOF). After the administration of reversal, the anesthesiologist who are going to manage the participant should not check the quantitative neuromuscular monitoring and determine the timing of extubation only with his (or her) judgement. After entering post-anaesthesia care unit (PACU) measure the TOF value and check the incidence of TOF ratio \> 0.9 between the neostigmine group and sugammadex group.

Eligibility Criteria:
Inclusion Criteria:

* patients aged over 18 years, planned to undergoing elective laparoscopic surgery under general anesthesia

Exclusion Criteria:

* Obesity BMI over 30 kg/m2
* Impairment of renal or/and liver function
* Allergy to rocuronium, sugammadex
* (Familial) history of malignant hyperthermia
* Taking medicines which is affecting neuromuscular function
READI (Readiness Evaluation And Discharge Interventions) Study

Preparation of patients for discharge is a primary function of hospital-based nursing care and readiness for discharge is an important outcome of hospital care. Inadequacies in discharge preparation have been well-documented and linked to difficulty with self-management after hospital discharge and with increased likelihood of emergency department (ED) use and readmission. Prior studies by the research team have led to recommendations for implementation of discharge readiness assessment as a standard nursing practice for hospital discharge.

The investigators will conduct a multi-site study to determine the impact on post-discharge utilization (readmission and ED visits) and costs of implementing discharge readiness assessment as a standard nursing practice for adult medical-surgical patients discharged to home. The study tests, in a stepped approach, the impact of implementing discharge readiness assessment by the discharging nurse as standard nursing practice (RN-RHDS protocol), the incremental value of informing the nurse assessment with the patient's perspective (RN-RHDS+PT-RHDS protocol), and of requiring that the nurse initiates and documents risk-mitigating actions for patients with low readiness scores (RN-RHDS+PT-RHDS+NIAF protocol).

HYPOTHESIS 1: Patients discharged using the RN-RHDS protocol will have fewer hospital readmissions and ED visits within 30 days post-discharge compared to patients discharged under usual care conditions.

HYPOTHESIS 2: Patients discharged using the RN-RHDS+PT-RHDS protocol will have fewer hospital readmissions and ED visits within 30 days post-discharge compared to patients discharged using the RN-RHDS protocol.

HYPOTHESIS 3: Patients discharged by nurses using the RN-RHDS+PT-RHDS protocol plus a Nurse-Initiated Action Form \[NIAF\] (RN-RHDS+PT-RHDS+NIAF protocol) will have fewer post-discharge readmissions and ED visits than patients discharged using the RN-RHDS+PT-RHDS protocol; the effect will be strongest for patients with low RHDS scores.

Aim 4: Conduct cost-benefit analysis of implementing discharge readiness assessment as standard practice, by comparing cost-savings from reduced post-discharge utilization against implementation costs.


Eligibility Criteria:
Inclusion Criteria:

* Medical, surgical, or medical-surgical nursing units of Magnet designated hospitals
* Patients 18 years of age or more, English speaking,able to read and understand consent who are being discharged to home as the discharge destination.
* Nursing personnel (Registered Nurses or Licensed Practical Nurses) who are performing discharge instructions and procedures on the day of hospital discharge.

Exclusion Criteria:

* Patients discharged to home with hospice care.
The Impact of Post Stenting Balloon Dilatation on Coronary Microcirculation in STEMI Patients Undergoing PPCI

This study aims to assess the impact of NC balloon post-dilatation on coronary microcirculation in patients with ST segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PPCI).

Suboptimal stent deployment can lead to future stent failure. Thus, optimising stent deployment with non-compliant balloons (NC balloon) post dilatation (PD) at high pressures is an established strategy. In the context of ST segment elevation myocardial infarction (STEMI), PD has been correlated anecdotally with the no reflow phenomenon.

This study aims to determine the impact of stent post-dilation (PD) with NC balloons at high pressures on coronary microcirculation during PPCI by measuring the index of microcirculatory resistance (IMR) pre and post stent post-dilatation. Pre and post PD, an optical coherence tomography (OCT) study will be performed to assess stent deployment and identify parameters that predict the changes in IMR.

Eligibility Criteria:
Inclusion Criteria

* \>18 years of age
* Acute symptoms onset with duration \> 20 minutes
* ST-segment elevation ≥ 0.1 mV in ≥ 2 contiguous leads, signs of a true posterior infarction or documented newly developed left bundle branch block
* Infarct related artery with a diameter above 2.5 mm
* Operator's intention to proceed to stent deployment (i.e. not refer for CABG or defer PCI)

Exclusion Criteria

* \< 18 year of age
* Symptoms duration \> 12 hours
* Unable to give informed consent
* Previous bypass graft surgery
* Previous myocardial infarction
* Pregnancy
* Known severe chronic kidney disease (creatinine clearance ≤30 mL/min), unless the patient is on dialysis
* Unable to receive antiplatelets or anticoagulation (i.e. coagulation disorders, bleeding etc.)
* Haemodynamic instability
* Severe LMS disease
* Culprit vessel diameter \< 2.5 mm
* Contraindications to adenosine
* Any study lesion characteristic resulting in the expected inability to deliver OCT catheter to the lesion pre and post PD (e.g. moderate or severe vessel calcification or tortuosity)
IL1RAP-targeting Chimeric Antigen Receptor T Cells in the Treatment of Relapsed/Refractory Hepatocellular Carcinoma

A Phase 1 Study of IL1RAP-targeting Chimeric Antigen Receptor T cells in the Treatment of Relapsed/Refractory Hepatocellular Carcinoma


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-70 years old, male or female;
2. Patients with advanced hepatocellular carcinoma who are confirmed by histopathology and/or cytology to be ineligible for surgery and local radical therapy and who have developed tumor progression or toxicity intolerance following at least one standardized systemic therapy (including molecularly targeted agents and immune checkpoint inhibitors) or interventional therapy
3. Liver cancer subjects with stage II or III of China Liver Cancer Staging (CNLC) as defined by Barcelona Clinic Liver Cancer (BCLC) B/C level or the Code of Practice for Primary Liver Cancer Diagnosis and Treatment (2022 edition);
4. Expected survival ≥3 months
5. Before the start of the research related procedures, after explaining the research content, voluntarily participate and be able to sign the informed consent; Agree to and have the ability to follow study visits, imaging tests, laboratory tests, and other research procedures in the study plan;
6. Good compliance, willing and able to follow all research procedures, and cooperate with observation and follow-up.

Exclusion Criteria:

1. Have had other uncured malignancies within the past 5 years or at the same time, except for in situ cancers considered clinically curable, such as cervical carcinoma in situ and basal cell carcinoma of the skin
2. Central nervous system metastases and clinically significant central nervous system diseases
3. Pregnant or lactating women;
4. The investigator believes that the subjects have any circumstances that make them unfit to participate in this clinical study.
Phenolic-rich Oats and Artery Improvement

In this proposed human trial, the investigators aim to establish whether consumption of one portion of phenolic acid-rich oats leads to acute improvements (i.e. 1-24h post-intake) in markers of cardiovascular disease risk relative to an energy matched control intervention in healthy men with high-normal to mildly elevated blood pressure.

A diet rich in whole grain is inversely associated with cardiovascular disease risk. Whole grains contain a wide range dietary components including potentially vasoactive phenolic acids.

Eligibility Criteria:
Inclusion Criteria:

* Above average blood pressure (i.e. systolic 120-159 mmHg and diastolic 75-99 mmHg)

Exclusion Criteria:

* Abnormal biochemical, haematological results as assessed at health screening
* Hypertension (i.e. systolic/diastolic blood pressure ≥160/100 mm Hg) BMI \>35
* Current smoker or ex-smoker ceasing \<3 months ago
* Past or existing medical history of vascular disease, diabetes, hepatic, renal, gastrointestinal, haematological, neurological, thyroidal disease or cancer
* Prescribed or taking lipid lowering, antihypertensive, vasoactive (e.g. Viagra), anti-inflammatory, antibiotic or antidepressant medication
* Allergies to whole grains
* Parallel participation in another research project
* Having flu vaccination or antibiotics within 3 months of trial start
* On a weight reduction regime or taking food supplements within 3 months of trial start
* Performing high level of physical activity (i.e. \>3 x 20 min aerobic exercise/week)
* Consumption of ≥21 units of alcohol/week
* Small veins not allowing cannulation
SNC115 Injections in Patients With Recurrent/Refractory Small Cell Lung Cancer and Lung Large Cell Neuroendocrine Carcinoma

This study is a FIH dose escalation clinical study, with single arm, open label and design, in order to observe the preliminary safety and Pharmacokinetic of SNC115 Injection in participants with Recurrent/refractory small cell lung cancer and Lung large cell neuroendocrine carcinoma.

The study will enroll at most 35 participants diagnosed with Recurrent/refractory small cell lung cancer or Lung large cell neuroendocrine carcinoma.

There will be about 5 preset dose groups in this clinical trial, Participants will be enrolled from low dose group to high dose group. Dose escalation will be decided by the SRC (Safety Review Committee). There will be expanded cases in the aim dose group.

The protocol will be performed into Screening period (-30+ days), Mononuclear cells acquisition, Lymphodepletion (-5\~-3 days), SNC115 Injection infusion and DLT observation period (day 0\~28days), and follow-up period (1-5 years). According to the administration strategy, we will start from single administration.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old, regardless of gender;
2. Histological or cytological diagnosis of SCLC or pulmonary LCNEC (WHO 2021)
3. Relapse or refractory after receiving at least first-line standard therapy, or inability to tolerate first-line standard therapy
4. Eastern Cooperative Oncology Group score 0-1;
5. At least one measurable tumor lesion (other than brain metastases) according to solid tumor response criteria 1.1 (RECIST1.1)
6. Measurable lesions with an expected survival of more than 3 months;
7. Expected survival ≥12 weeks.
8. Adequate organ and bone marrow function.
9. The subjects agreed to use reliable contraceptive methods for contraception within 1 year from the signing of informed consent to reinfusion.
10. Voluntarily participate in clinical trials and sign informed consent.

Exclusion Criteria:

1. Known allergic reaction, hypersensitivity, intolerance or contraindication to SNC115 Injection or any component of drugs that may be used in the study (including fludarabine, cyclophosphamide and Tocilizumab).
2. Have received any previous CAR-T therapy or other gene-modified cell therapy.
3. Have received any previous treatment targeting DLL3.
4. Uncontrolled pleural effusion, pericardial effusion, and ascites (uncontrolled refers to repeated drainage).
5. Untreated (including new lesions or progression after previous treatment) or symptomatic brain metastases.
6. Have medical history of study excluded thrombosis, Systemic autoimmune disease, cardiopathy, cancer, infection disease and so on.
Optic Nerve Head Strain as Biomarker for Glaucoma

The investigators will test the hypothesis that images of the optic nerve head taken a 2 different eye pressures will yield strain estimates that are predictive of the course of glaucoma.

Existing glaucoma patients and suitable control adults will be imaged with an FDA-approved optical coherence tomography instrument. Those who are imaged at 2 different eye pressures will generate biomechanical strain estimates. These will be compared to visual field and retinal nerve fiber layer measurements over time. The investigators expect that baseline strain and their changes over time will be associated with progression rate of glaucoma damage, providing a biomarker for susceptibility.

Eligibility Criteria:
Inclusion Criteria:

* Existing glaucoma patients of Johns Hopkins

Exclusion Criteria:

* Inability to perform imaging
* illiterate
* hearing impaired
* non-English speakers
Tumor-Informed ctDNA Testing of Head & Neck Intent Treatment of Squamous Cell Carcinoma

This is a single-center, non-interventional, observational study that evaluates the correlation of circulating tumor DNA (ctDNA) testing to cancer relapse for participants with head and neck squamous cell carcinomas (HNC) after curative-intent primary radiation or surgery.

PRIMARY OBJECTIVE:

I. To determine the rates of detectable ctDNA within two years of participants treated with curative-intent surgery or radiation-based treatment for HNC.

SECONDARY OBJECTIVES:

1. To describe the prevalence of detectable ctDNA at initial diagnosis in participants with HNC.
2. To describe the association of quantitative ctDNA levels with time-to-event outcomes (overall survival (OS), disease-free survival (DFS), and time to recurrence (TTR)).
3. To describe the association of quantitative ctDNA levels with follow-up imaging tumor volume.

OUTLINE:

Participants will have tissue samples collected at screening and blood samples collected for analysis before, during, and after non-investigational, standard of care treatment for cancer for up to 2 years

Eligibility Criteria:
Inclusion Criteria:

1. Participants must have histologically or cytologically confirmed squamous cell carcinoma of the head and neck.
2. Participants must be age \>=18 years.
3. Participants must be planning to receive curative-intent surgery or radiation-based treatment as part of standard of care treatment.
4. Participants must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Contraindication to phlebotomy for removal of 20 mL of peripheral blood each time point (up to 300 mL total over 15 time points).
THA With and Without Computer Navigation

The goal of this observational study is to compare postoperative results between patients who had total hip arthroplasty (THA) with and without the use of a computer navigation program. The main questions this study aims to answer are:

* Can using computer navigation produce better THA implant placement?
* Can using computer navigation make surgery more efficient?

Participant data collected include their postoperative x-rays and total operative time.

The goal of this retrospective study is to compare implant placement and operative time of patients who underwent direct anterior total hip arthroplasty with and without the use of a computer navigation program. X-rays are used to measure acetabular cup orientation, leg length discrepancy, and total operative time.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent Direct Anterior (DA) THA with the principal investigator between August 2018 and February 2020 and received ACTIS stem and PINNACLE cup with or without computer navigation

Exclusion Criteria:

* Patients who underwent subsequent revision THA, conversion arthroplasty, hybrid procedures, experienced native or postoperative dislocations, and missing or inadequate radiographs at time of data collection.
Serum Kisspeptin Levels in Infertile Women

The study population is comprise of 90 women those age varies between 18-38 year-old. The first group will comprise of 30 women with polycystic ovaries or anovulatory cycles, the second group will comprise of 30 women with diagnosis of unexplained infertility and the third group will comprise of 30 women those partners with male subfertility. A 2 cc blood sample for Kisspeptin analysis will be drawn from the antecubital vein from each participants. The patients will receive 50 mg clomiphene citrate at the fifth day of the menstrual period and follicular development will be measured with serial ultrasound follow up.

The study population is comprise of 90 women those age varies between 18-38 year-old with wish of baby for at least one year despite of unprotected sexual intercourse, patent tubes confirmed in hysterosalpingography , follicle stimulating hormone levels \<12 IU. The first group will comprise of 30 women with polycystic ovaries in ultrasound examination or anovulatory cycles, the second group will comprise of 30 women with diagnosis of unexplained infertility, normal menstrual periods and without known male factor infertility and the third group will comprise of 30 women those partners with sperm count between 5x106 -15x106 /mL, type A + type B motility \<%32 and Kruger morphology \<4%. A 2 cc blood sample for Kisspeptin analysis will be drawn from the antecubital vein from each participants and centrifuged and sera will be kept in -80 C till recruitment has been completed. Kisspeptin, E2, Progesterone, anti-mullerian hormone levels will be measured with ELISA method. The patients will receive 50 mg clomiphene citrate at the fifth day of the menstrual period and follicular development will be measured with serial ultrasound follow up.

Eligibility Criteria:
Inclusion Criteria:

* ages varying between 18-38 year-old with wish of baby for at least one year despite of unprotected sexual intercourse
* patent tubes confirmed in hysterosalpingography
* follicle stimulating hormone levels \<12 IU
* no other relevant medical history

Exclusion Criteria:

* ages other than 18-38 year-old with wish of baby for least than one year despite of unprotected sexual intercourse
* obstructed tubes confirmed in hysterosalpingography
* follicle stimulating hormone levels \>12 IU
* history thyroid disease
* increased prolactin levels
* history of chemo/radiation therapy
The Comparison of Oxidative Stress Between Inhalation Anesthetics

Oxidative stress is an unavoidable event during cardiac surgery. Isoprostanes have been demonstrated to be a reliable biomarker for the evaluation of oxidative stress in vivo.The aims of this study are(1)to develop an accurate liquid chromatography-tandem mass spectrometry methods for the detection of urinary isoprostane isomers in samples collected from healthy volunteers(for method quality control) and patients receiving a cardiac surgery (2)to investigate the change of isoprostanes after cardiopulmonary bypass(CPB) (3)to investigate the effect of different anesthetics on isoprostanes.

Enhanced production of oxygen free radicals can lead to the generation of oxidative stress, which is harmful to human tissue and organs. Reactive oxygen species are released abruptly during some surgical procedures, and they are the major causes of ischemia-reperfusion injuries.Isoprostanes have been demonstrated to be a reliable biomarker for the evaluation of oxidative stress in vivo. Therefore, accurately monitoring and avoiding the occurrence of oxidative stress during surgery is an important clinical issue.

Isoprostanes are a series of prostaglandin-like compounds produced by non-enzymatic peroxidation of arachidonic acid.The aims of this study are(1)to develop an accurate liquid chromatography-tandem mass spectrometry methods for the detection of urinary isoprostane isomers in samples collected from patients receiving a cardiac surgery (2)to investigate the change of isoprostanes after cardiopulmonary bypass (3)to investigate the effect of different anesthetics on isoprostanes during surgery.

Eligibility Criteria:
Inclusion Criteria:

* patients receiving cardiac valve surgery in ASA II-III physical status

Exclusion Criteria:

* trauma, infection, low ejection fraction (less than 25%), liver cirrhosis, or acute renal failure, and emergency surgery
Computational Modeling for Prediction of Acoustic Changes in Vowel Production Due to Orthognathic Surgery

A computational model of human sound production based on high quality anatomic measurements and physical laws of sound propagation cannot be accomplished without a comprehensive data set including both 3D-images of the speaker's anatomy and the simultaneous recording of speech. Since the computational model has separate models for the vocal folds and the vocal tract, patients undergoing an orthognathic surgery is an optimal test object for the model development. Vocal folds remain unchanged while substantial changes take place in the vocal tract. Moreover, since the aim of the research is to predict acoustic changes in speech due to operations in head neck area, the orthognathic patient group is par excellence an example of such a prediction problem. If the model can be shown to give valuable information pre-operationally, many other patient groups could benefit from the results.

Orthognathic surgery deals with the correction of abnormalities of the facial tissues. The underlying cause for abnormality may be present at birth or acquired during the life as the result of distorted growth or trauma. Orthodontic treatment alone is not adequate in many cases due to severity of the deformities. In a typical operation, the position of either one jaw (mandible or maxilla) or both jaws is surgically changed in relation to the skull base. The movement of the jaw position varies usually between 5-15 mm either to anterior or posterior direction. Such a considerable movement has a very profound effect on the shape and volume of vocal tract resulting detectable changes in acoustics. Although the surgery involves mandibular and maxillary bone, changes occur also in the position and shape of respective soft tissues and hyoid bone, as well. For this project, 20 adult patients (10 women and 10 men) undergoing orthognathic surgery will be enrolled. Exclusion criteria include diseases and conditions in which MRI examination is contraindicated (.e.g. pace maker), severe speech or hearing impairment, and other situations where the patient has difficulties with completing the tasks defined in the research protocol. Furthermore, patients to whom segmental surgery of the jaws will be performed in connection of orthognathic surgery are excluded. A specific pre-selection criterion for patients is the presence of numerous dental amalgam fillings that may cause artifacts in MR images.

Eligibility Criteria:
Inclusion Criteria:

- Healthy patients undergoing orthognathic surgery

Exclusion Criteria:

* Patients with conditions in which MRI examination is contraindicated (e.g. pace maker)
* Patients who require several operations or segmented jaw surgery
* Patients with cognitive impairment
* Patients with numerous dental amalgam fillings that may cause artifacts in MR images