cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetics of Vancomycin in the ICU in Renal Replacement Therapy

This study is an observational analysis that monitors the effect of different dialysis methods on vancomycin levels when patients are critically ill. No changes are made to therapy based on levels, but levels are checked more frequently than normal. The primary dialysis methods being studied are SLED (slow-low efficiency daily) dialysis and intermittent hemodialysis. Vancomycin is the only medication being evaluated in this study. This study will provide detailed information on how to dose vancomycin in patients that are on dialysis in the intensive care unit.

The proposed study will evaluate the pharmacokinetics of vancomycin in patients that are on being treated with various types of renal replacement therapy. The renal replacement therapies studied in this trial will be slow-low efficiency daily (SLED) dialysis and intermittent hemodialysis. This data will be collected and plotted for vancomycin for each dialysis mechanism utilized and plotted on drug concentration versus time graphs to determine drug clearance in each type of renal replacement therapy. Subjects will have blood samples drawn and sent to the laboratory according to the dialysis method studied (9 for SLED dialysis and 10 samples for intermittent hemodialysis). Serial levels will be drawn prior to the drug being administered and after the drug is infused to assess the clearance and distribution of vancomycin. Study drug levels will be drawn from blood that is already available in the laboratory when timing of such samples is appropriate, in order to limit the amount of blood that is drawn from each study subject. A total of 30 milliliters of blood will be collected from each subject for any one study arm they fit into. Blood will be collected no more than two times per week and only more than once in a particular patient if their dialysis regimen changes. A single particular subject will only be able to supply blood samples once for each dialysis regimen being studied. This study would allow for the data collection of vancomycin levels at several time points during renal replacement therapy to assess the pharmacokinetic parameters associated with vancomycin dosing in each specialized patient-dialysis combination.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age
* One of the following types of dialysis modalities implemented:

Slow-low efficiency daily dialysis Intermittent hemodialysis

* Use of study medication (vancomycin)

Exclusion Criteria:

* Inability to give informed consent
Perceptual Influences from Smoking Cannabis: an Experimental Study

The purpose of the study is to better understand the effects of cannabis in relation to mental and physical states including its relationship with mood, cognition, perception including the experience of temperature and pain, and heart rate.

We expect that participants will be in this research study for approximately one week. The total amount of time that participants will spend completing study tasks will be about 2.5 hours across two separate in-person visits.


Eligibility Criteria:
Inclusion Criteria:

* 21-65 years of age
* Endorsement of at least moderate use of cannabis for coping purposes (≥2.5 on CMMQ)
* Regularly use flower cannabis products (i.e., ≥1x/week in the last 6 months)
* Proficient in English language
* At least occasional use of CBD+THC or CBD-dominant products (e.g., ≥1x/month)

Exclusion Criteria:

* Diagnosis or use of medications for substance use or psychotic disorders
* Report of other drug use (cocaine, opiates, methamphetamine) in the past 90 days or fail urine screen for any of these drugs
* Females cannot be pregnant or trying to become pregnant or nursing mothers
* Not able to provide informed consent
The Role of Tegaserod Therapy in the Management of Dyspeptic Symptoms in Female Patients on Proton Pump Inhibitors for the Treatment of Heartburn.

Study to provide initial data to assess the safety and efficacy of tegaserod use in patients with dyspepsia that are being treated with proton pump inhibitors (PPI's) for heartburn.


Eligibility Criteria:
Inclusion Criteria:

* Female patients 18 years or older.
* Self-reported presence of symptoms consistent with dyspepsia (including mid-upper abdominal discomfort characterized by post prandial fullness, early satiety and bloating)
* Stable dose PPI therapy of at least 4 weeks

Exclusion Criteria:

* History of intestinal obstruction, symptomatic gallbladder disease, suspected sphincter of Oddi dysfunction, or of abdominal adhesions.
* Evidence that the dyspeptic symptoms are relieved by defecation and/or associated with a change in frequency or stool form.
* With a current most bothersome symptom of heartburn.

Other protocol-defined inclusion/exclusion criteria may apply.
Preventing Firearm Violence in Youth: A Hospital-based Prevention Strategy

The goal of the study is to understand if hospital-based violence interventions are effective for reducing youth violence among violently injured youth. This study will allow researchers to learn more about the intervention's effectiveness. The researchers also want to understand if the violence intervention impacts other behaviors, such as firearm use, drug use, aggression, risky behaviors, and rates of violent re-injury.

The purpose of this research study is to find out if a hospital-based violence intervention (Bridging the Gap) is effective for reducing youth violence. Researchers think that youth who receive the Bridging the Gap will see greater improvements than youth who do not receive the intervention. Approximately 300 youth patients and 300 adult caregivers will enroll in this study. Participants will be randomized into a study group (either Bridging the Gap or Treatment as Usual). If patients agree to the study but do not like the group they are assigned to, they can request to switch groups. Participants assigned to the Treatment as Usual intervention will receive a brief violence awareness brochure during their hospital stay. Participants assigned to the Bridging the Gap intervention will receive an in-hospital intervention and, once released from the hospital, will receive 3-months of community case management services with their families. The study team thinks that youth who receive the Bridging the Gap intervention will see greater improvements than youth who do not receive the intervention. Participation in this study will last up to 6 months.

Eligibility Criteria:
Inclusion Criteria:

1. Youth are aged 10-17 years and their adult caregivers are aged 18 years and older
2. Receiving treatment in the hospital for a violence-related injury (e.g., gunshot wound) or referred to BTG/IVPP services
3. English speaking
4. Eligible for BTG services (which includes living within the BTG catchment area for the hospital; Richmond City and neighboring counties)

Exclusion Criteria:

1. Youth are \< 10 years old
2. Youth are \> 18 years old
3. Prisoners
Virtual Physical Activity Seated Exercise - Phase 2

This study will determine the acceptability of delivering seated exercises online and if seated exercises can improve balance, mobility, quality of life, and cardiometabolic health in those living with a stroke related mobility impairment.

Participants will be allocated to either a 10-week seated exercise program or a delayed 2-week Boot Camp program. All seated exercises sessions and assessments will be conducted virtually.

The study will be a virtual 10-week multi-site, assessor-blinded, randomized controlled trial with an embedded qualitative component. The study will be conducted in real time using secure videoconferencing software (Zoom). Participants will be randomized 1:1 to a 10-week Seated Exercise group or a delayed 2-week Seated Exercise Group (Boot Camp). Seated exercise sessions will be delivered and supervised by a trained instructor.

Participants will use their own computer, laptop, or tablet for the zoom sessions. No Zoom sessions will be recorded. Caregivers will be invited to attend each exercise session to provide support and assistance but are not obliged to attend. A caregiver, friend, or family member will be required for each assessment to participate in the study.

Eligibility Criteria:
Inclusion Criteria:

Participants must meet the following inclusion criteria:

* Adult (as defined by Province)
* Chronic stroke (more than 6 months post-stroke)
* Ability to stand up from a chair
* Mobility impairment of lower extremity (requires a walking aid, with or without close supervision)
* Able to safely engage in exercise and tolerate 60 minutes of exercises
* Able to communicate in English
* Have access to a tablet, computer, or laptop with internet and email access

Exclusion Criteria:

Participants will be excluded if they meet any of the following criteria:

* Participating in formal exercise or rehabilitation activities
* Participating in \> 30 minutes/day of physical activity (moderate intensity)
* Participating in another study that may affect outcomes to this study
* Severe loss of vision, hearing, speech (including aphasia) or cognition that would preclude use of a computer/tablet and communication over videoconference software
* A serious comorbid condition (eg., amputation, Parkinson's disease, active cancer)
* Clinically diagnosed with acute/chronic illness or other condition which has known physical activity contraindications or limits their ability to complete each experimental condition (i.e., chronic low back pain aggravated by prolonged sitting)
Online Positive Emotion Skills Intervention for Symptoms of Depression

Major depressive disorder affects over 120 million people worldwide. Only 50% of Americans with depression receive adequate treatment, and one-third of those receiving treatment do not benefit. In this pilot project investigators will bring together two approaches that have the promise to reach large numbers of depression sufferers: a skills-based intervention for increasing positive affect and experiences in depressed individuals, delivered in an inexpensive self-paced mobile format. The study will make use of smartphone technology to improve conventional outcome measurement via in-the-moment emotion sampling and mobile assessment of heart rate variability, a predictor of cardiac health that may mediate some of the health effects of depression. The aims are: 1) Retool the existing web-based positive emotion intervention for use on smartphones, with innovative exercises that help participants bring the skills they are learning into real-life situations; 2) Perform a small feasibility trial of the mobile intervention on individuals with clinical depression recruited online 3) Eventually incorporate feedback from the small feasibility trial to improve the online intervention and conduct a full randomized trial on a larger scale


Eligibility Criteria:
Inclusion Criteria:

* Daily internet access
* Cell phone ownership
* Score of 5 or higher on PHQ-8 scale
* Lives in US or Canada
* Speaks and reads English, able to provide informed consent
Use of a Vacuum Mattress During Laparoscopic Sleeve Gastrectomy to Reduce the Concentration of Rhabdomyolysis Markers and Acute Renal Failure

This prospective clinical trial aimed to assess the usefulness of the usage of a vacuum mattress during laparoscopic sleeve gastrectomy (LSG) in the reduction of levels of rhabdomyolysis markers (myoglobin, creatine kinase, creatinine) and incidence of RML and AKI in the postoperative period.

Method Patients

A prospective clinical trial has been conducted between January 2015 and December 2022 in a tertiary referral University Hospital (Krakow, Poland). It is designed as a single-center, prospective trial with two intervention arms. During the study, we specified 3 periods:

* January 2015 - December 2016 - only standard mattresses were used
* January 2017 - December 2019 - both types of mattresses were used
* January 2020 - December 2022 - only vacuum mattresses were used

Participants Patients aged ≥18 were qualified for LSG due to obesity and divided The first group (Vacuum Mattress group) are those laid on vacuum mattresses during the surgery. The control group consisted of patients for whom a standard operating mattress was used during the surgery. Patients with preoperative chronic renal failure were excluded from the study. Other exclusion criteria were perioperative complications which required postoperative hospitalization at the Intensive Care Unit and Compliance with Enhanced Recovery After Bariatric Surgery (ERABS) Protocol \< 85%.

Procedures and perioperative care All patients underwent LSG. Patients were operated in the beach chair position. In the study group, the patient was laid on vacuum mattresses during the surgery. In the case of control group patients, a standard operating mattress was used during the surgery. Perioperative care for all patients was in accordance with the ERABS protocol adopted in our center\[\]. Blood samples were collected on the first postoperative to measure RML markers (myoglobin, creatine kinase, creatinine). Symptoms of RML, AKI, and other complications were monitored for 30 days after surgery.

End Point Criteria The primary endpoint is the incidence of postoperative AKI or biochemical or clinical diagnosis of RML which required additional treatment.

Secondary endpoints is the concentrations of RML markers (myoglobin, creatine kinase, creatinine) on the first postoperative day


Eligibility Criteria:
Inclusion Criteria:

Patients aged ≥18 which will be qualified for LSG due to obesity

Exclusion Criteria:

Patients with preoperative chronic renal failure will be excluded from the study. Other exclusion criteria are perioperative complications which require postoperative hospitalization at the Intensive Care Unit and Compliance with Enhanced Recovery After Bariatric Surgery (ERAbSERABS ) Protocol \< 85%.
Efficacy of Lidocaine Gel in Reducing Foley Catheter Discomfort in Surgical Patients

This study will evaluate whether lidocaine gel for urinary catheter insertion would decrease pain and discomfort associate with Foley catheters upon awakening from general anesthesia in the post anesthesia care unit. As a secondary objective, the study will evaluate bacterial colony counts from urine obtained from the surgical patients after insertion of the Foley catheter prior to prophylactic antimicrobial administration.


Eligibility Criteria:
Inclusion Criteria:

* Males requiring catheterization for surgical procedures scheduled for less than 4 hours.

Exclusion Criteria:

* Females, patients with preexisting urological conditions, and infections
Using Deep Learning and Radiomics to Diagnose Benign and Malignant Breast Lesions Based on Ultrasound

This retrospective study aimed to create a prediction model using deep learning and radiomics features extracted from intratumoral and peritumoral regions of breast lesions in ultrasound images, to diagnose benign and malignant breast lesions with BI-RADS 4 classification.

Materials and methods: Patients who visited in The First Affiliated Hospital of Shandong First Medical University ＆ Shandong Provincial Qianfoshan Hospital were collected. Their general clinical features, information on preoperative ultrasound diagnosis, and postoperative pathologic data were reviewed.


Eligibility Criteria:
Inclusion Criteria:

* female patients with US-visible solid breast masses who underwent biopsy and/or surgical resection, and were classified as having BI-RADS 4 lesions in medical US reports.

Exclusion Criteria:

* preoperative endocrine therapy, chemotherapy, or radiotherapy, preoperative invasive breast operation, insufficient image quality, and no pathological results.
MIRENA for Contraception In InDian Subjects User continuAtion and Satisfaction Study: MIDAS Study

The study is designed as non interventional to observe the continuation rate and the patient satisfaction in women who have a LNG-IUS (Levonorgestrel releasing Intrauterine system) inserted for contraception over the period of 12 months under real life condition in India.The study will begin after the study approval by ethics committee.All Indian women aged between 18-49 years who are initiating LNG IUS therapy for contraception will be included in study after taking the informed consent.Patients will be observed for upto 12 months.The study involves general examination of patients, collection of data like medical history, previous contraceptive use,concomitant medication etc.The study is planned to enroll 600 subjects from multiple study centers spread across India. The study data will be analyzed with appropriate statistical methods.


Eligibility Criteria:
Inclusion Criteria:

* Subject aged between 18-49 years who are initiating LNG IUS therapy for contraception.
* Subject willing to provide informed consent and comply with study procedure.

Exclusion Criteria:

* Exclusion criteria must be read in conjunction with the local product information.
Fetal Doppler and Uterine Artery Blood Volume Correlation.

To investigate the relationship between uterine artery blood volume and fetal doppler indices at the delivery.

Introduction: To investigate the relationship between uterine artery blood volume and fetal doppler indices at the delivery.

Materials and Methods: This was a prospective cohort study of 50 nulliparous women booking antenatal care at the University of Campania "Luigi Vanvitelli" between May 2022 and September 2022. All full-term pregnancies accepted for delivery will include. Pregnant women with antepartum haemorrhage, stillbirths, multiple gestations, or congenital abnormalities were excluded. Women underwent a transabdominal ultrasound examination of uterine arteries for measurement of Uterine artery blood volume. Pregnancy outcomes were recorded, and linear regression was used to study the relationship between uterine artery blood volume and fetal Doppler indices. SPSS version 25 (Chicago, IL, USA) was used to code, tabulate, and analyze the data. Quantitative data were analyzed using the student's t-test. Qualitative data were analyzed using the Mann-Whitney test. A statistically significant difference was defined as a p-value of 0.05.

Eligibility Criteria:
Inclusion Criteria:

* full-term pregnancies (37-42 weeks)

Exclusion Criteria:

* antepartum hemorrhage, fetal growth restriction, stillbirths, multiple gestations, or congenital abnormalities
Fertility After Transvaginal Surgery or Uterine Artery Embolization Combined With Uterine Curettage in Patients With Cesarean Scar Pregnancy

To investigate the fertility in patients after treatment by transvaginal surgery or uterine artery embolization combined with uterine curettage


Eligibility Criteria:
Inclusion Criteria:

* increased levels of serum β-hCG and ultrasonography findings. The criteria for diagnosis by ultrasonography was the presence of the following: (1) an empty uterine cavity and endocervical canal; (2) detection of the placenta and/or a gestational sac embedded in the hysterectomy scar; (3) the presence of the gestation sac with or without a fetal pole and with or without fetal cardiac activity (depending on the gestational age) in the anterior part of the uterine isthmus; and (4) a thin (1-3 mm) or absent myometrial layer between the gestational sac and the bladder(24). All patients had taken Magnetic Resonance Imaging (MRI) to clarify the diagnosis . Pregnancy tissues were identified by histopathology examinations of the surgical tissues.

Exclusion Criteria:

* All enrolled patients had no contraindications for transvaginal surgery or UAE, including renal failure, active pelvic infection, clotting disorders, or known allergy to the contrast material.
AKI Biomarkers in Coronavirus(COVID)-19

This research aims to investigate the role of daily measurement of urinary cell cycle arrest markers and other serum and urinary biomarkers to predict the development of acute kidney injury in critically ill patients with COVID-19 and acute respiratory disease.

COVID-19 is a rapidly evolving pandemic with approximately 5% of all patients requiring admission to an intensive care unit. In critically ill patients with COVID-19, acute respiratory disease and acute kidney injury (AKI) are very common. Patients with AKI have an increased risk of mortality, especially renal replacement therapy (RRT) is required. The latest Intensive Care National Audit \& Research Centre (ICNARC) report shows a 77% ICU mortality in patients with COVID-19 who require mechanical ventilation and RRT.

COVID-19 associated AKI is still poorly understood. The exact underlying pathophysiology remains unknown. Furthermore, there are no specific strategies to prevent or treat AKI. Management is supportive consisting of fluid and haemodynamic optimization, discontinuation of nephrotoxic drugs and prevention of nephrotoxic exposures. Ideally, AKI needs to be recognized as early as possible for these supportive measures to be effective.

Early prediction of AKI may be valuable to optimize management and improve outcomes. In critically ill patients without COVID-19, the two cell-cycle arrest markers, tissue inhibitor of metalloproteinases-2 (TIMP-2) and insulin-like growth-factor binding protein 7 (IGFBP7), have been shown to predict the development of AKI. Whether these new biomarkers also predict the development of AKI in critically ill patients with COVID-19 is unknown.

The aim of this project is to explore whether urinary cell cycle arrest markers and other renal biomarkers have a role in predicting AKI in critically ill patients with COVID-19 and acute respiratory disease. The results will advance the understanding of this disease and serve to develop strategies for individualized management of this high-risk group.

Eligibility Criteria:
Inclusion Criteria:

1. Moderate or severe respiratory disease as defined by Berlin criteria
2. COVID-19 positive
3. Age ≥ 18 years

Exclusion Criteria:

1. pre-existing AKI
2. severe chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) \<20ml/min
3. end-stage renal failure on regular dialysis
4. kidney transplant within the last 12 months
5. pregnancy
6. breastfeeding
Septic Encephalopathy and Late Cognitive Dysfunction

Delirium and long-term cognitive dysfunction are important problems in intensive care patients. Patients with sepsis are at a high risk of developing delirium (septic encephalopathy), which may be an important risk factor for the development of long-term cognitive dysfunction.

Working hypotheses: 1. Septic encephalopathy and cognitive dysfunction are caused by an unspecific reaction of the brain to an intense inflammatory stimulus. 2. It is possible to therapeutically influence the inflammatory response and its effects on the brain.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to an intensive care unit for treatment of sepsis, severe sepsis or septic shock
* Age 18 or older

Exclusion Criteria:

* Primary infection of the CNS
* History of cerebrovascular disease
* History of any neoplasia involving the CNS
* History of long-term psychiatric medication
* History of allergy to fish- or egg-protein
* Severe coagulation abnormalities
* Clinical signs of altered coagulation, active bleeding
* Pregnancy