cyrilzakka/clinical-trials huggingface dataset:
Impact of Antibiotic Treatment on Prostate-Specific Antigen (PSA) Variability

Ciprofloxacin hydrochloride has been approved by the Food and Drug Administration (FDA) for the treatment of mild to moderate infections, including prostate infections. It has been suggested that antibiotic treatment influences PSA levels due to the fact that an increase in PSA levels may be caused by inflammation or swelling of the prostate. Antibiotics are used to treat such inflammatory conditions. However, it has not been proven that antibiotics can be used to lower PSA. This research is being done to see if treatment with the antibiotic Ciprofloxacin hydrochloride affects the Prostate-Specific Antigen (PSA) blood test. This study may also help doctors in deciding which patients need a prostate biopsy.

This study is directed towards men who have been referred to the Urology clinic at the Johns Hopkins Outpatient Center in Baltimore, MD. If a patient fits the eligibility criteria and signs a consent form, the patient will have his blood drawn for the first PSA measurement. The patient must return to the Johns Hopkins Outpatient Center one week later for a second PSA measurement. The patient will be randomized to receive treatment with placebo or Ciprofloxacin hydrochloride for 14 days. The patient must return to the Johns Hopkins Outpatient Center at the end of the treatment cycle for the third PSA measurement. The patient will return one week later for his biopsy and fourth PSA measurement.

Eligibility Criteria:
Inclusion Criteria:

* Must be a patient of Johns Hopkins Urology Outpatient Clinic
* Must have an elevated PSA (\> 2.5 ng/mL) and be selected on the basis of a serum PSA evaluation for Transrectal Ultrasound (TRUS)/biopsy
* Must be able to understand and willing to adhere to the study protocol
* Must be willing to take the antibiotic or placebo for two weeks prior to the biopsy and agree to have the biopsy regardless of the change in PSA

Exclusion Criteria:

* Abnormal digital rectal examination
* Anyone currently being treated or who have been treated for any prostatic diseases (prostatitis, prostate Benign Prostatic Hyperplasia (BPH) surgery, prostate cancer) or urinary tract infection in the past
* Anyone taking medications that are likely to alter serum PSA concentration (specifically, androgen steroid hormones, antiandrogens, finasteride, Leutinizing Hormone Releasing Hormone (LHRH) analogues)
* Anyone unwilling to sign the informed consent or who are unlikely to adhere to the study protocol
* Anyone with a known allergy to fluoroquinolone antibiotics
* Anyone on blood thinning medication (Coumadin)
* Anyone taking Tizanidine
* Anyone with a history of seizures or cerebral arteriosclerosis
* Anyone who has taken an antibiotic medication within the past two weeks
Learning Curve and Optimization of Robotic Gastrectomy

we explore the learning curve and the impact of technique optimization on surgical outcomes and the first to construct a referenceable learning phase for performing robotic gastric cancer surgery.


Eligibility Criteria:
Inclusion Criteria:

* Case inclusion criteria: (1) patients with pathologically confirmed gastric adenocarcinoma; (2) no distant metastases; and (3) R0 resection was performed.

Exclusion Criteria:

* Case exclusion criteria: (1) the presence of distant metastases was found ; (2) preoperative neoadjuvant chemotherapy was administered; and (3) clinical information was incomplete.
Prediction of Significant Liver Fibrosis

The deep learning method based on convolutional neural network (CNN) was used to extract the relevant features of liver fibrosis classification from the multi-modal information of digital pathological sections, clinical parameters and biomarkers of a large number of existing cases of liver puncture, and the U-Net architecture of CNN was used to segment and extract the features of clinical medical images.

Patients with chronic hepatitis B underwent B-ultrasound-guided liver biopsy, and were divided into mild liver fibrosis group (fibrosis grade 0-1, S1), significant liver fibrosis group (fibrosis grade 2, S2), advanced liver fibrosis group and early cirrhosis group (fibrosis grade 3-4, S3-4) according to the pathological results.In this study, 200 patients with different degrees of liver fibrosis and 200 normal volunteers were collected from 2018 to 2022, and their clinical biochemical data, imaging data and peripheral blood samples were collected.The pathological microenvironment characteristics, imaging characteristics, clinical parameter characteristics and other data of patients were extracted, and the distillation learning method based on teacher-student model was adopted to develop and construct a multi-modal big data analysis model for accurate grading of liver fibrosis, so as to achieve a non-invasive intelligent grading diagnosis system for liver fibrosis.

Eligibility Criteria:
Inclusion Criteria:

1. Age of 18-60 years old
2. The diagnosis of chronic hepatitis B is in line with the diagnostic criteria of China's 2019 Chronic Hepatitis B Prevention and Treatment Guidelines, and the diagnosis of non-alcoholic fatty liver is in line with the Asian Pacific Hepatology Association guidelines
3. Imaging showed no liver cancer

Exclusion Criteria:

1. There are contraindications for liver biopsy
2. Liver pathology did not meet the criteria
Pregabalin on Interleukin-6 Levels in Living Donor Kidney

Pregabalin, a ligand for alfa2delta subunits of voltage-gated calcium channels, has been shown to be an effective adjuvant therapy for acute postoperative pain, by inhibiting central sensitization. The IL-6, is detectable 60 minutes after surgical incision, persisting for until 10 days, with maximal plasmatic level in 4 and 6 hours. The objective of this study is evaluating the analgesic effect of pregabalin and its repercussion on serum levels of IL6.

After approved by the Ethical Committee and signed informed consent, 40 patients aged from 18 until 60 years undergoing nephrectomy will be randomized in two groups. Group 1 patients will receive a single dose of 300 mg pregabalin, 1 hour before the surgical incision; group 2 patients will receive a placebo dose. Pain intensity will be assessed with the numeric rating scale. The consumption of tramadol in 24 hours after surgery and the time for the first complementation dose will be registered. Blood samples will be collected by 6 hours and 24 hours after surgical incision, for IL-6 dosage, and maintained at -70 celsus degree. The IL-6 dosages will be performed by the ELISA (enzyme-linked immunosorbent assay) method. The number of patients was calculated by Instat Graph® program. To detect difference in pain intensity of 3 between the groups by NRS, with 95% of power (estimated SD= 2.0), when the alpha level is set at 0.05, the sample should be of 20. Statistical analyses will be performed with parametric and nonparametric tests, considering the variety studied. The statistical program that will be utilized is Instat Graph®.

Eligibility Criteria:
Inclusion Criteria:

* living donor kidney

Exclusion Criteria:

* myocardial ischemia
* psychiatric disease
* absence of chronic pain
* absence of drugs dependency
* don´t use of opioid medication 1 week before surgery
Trancranial Pulse Stimulation on Anterior Insula Cortex and Dorsal Anterior Cingulate Cortex

Transcranial pulse stimulation (TPS) is a newly developed non-invasive brain stimulation (NIBS) technique from Austria \&amp; Germany with highly promising applicability in neuropsychiatric disorders. Clinical trials have shown a beneficial effect of TPS in patients with Alzheimer\&#39;s disease and depression. Although TPS has the capability to noninvasively target deeper brain regions such as the dorsal anterior cingulate cortex (dACC) and anterior insula cortex (AIC), no TPS study has been conducted to investigate the feasibility and effectiveness of dACC or AIC stimulation. Here, a randomized, single-blind, sham-controlled clinical pilot trial is proposed to probe the effects of TPS over bilateral dACC and AIC on modulating cognitive, behavioral and emotional functions and functional connectivity of brain circuits.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65
* Biological and mental health, based on a clinical interview
* Able to understand and follow instructions by the study team

Exclusion Criteria:

* Major internal diseases, neurological disorders, or mental disorders
* Having a metal implant in the brain
* Corticosteroid treatment within 6 weeks prior to inclusion
* Pregnancy or breastfeeding
* Common NIBS and MRI exclusion criteria, such as a history of brain surgery, cardiac pacemaker, deep brain stimulation, and intracranial metallic particles
* Previous TPS experience
* Color blindness
Wearable and Patient-reported Outcome-based Continuous Assessment and Support Alerts in Palliative Care

Non-professional carers (typically family members) play a critical role in providing adequate home care. This research explores the use of wearable sensors (WS) and electronic patient-reported outcome (ePRO) surveys to monitor stress levels of advanced cancer patient/carer dyads. During wear times, WS-triggered ecological momentary assessments (EMAs) were conducted via short smartphone-based surveys. This pilot study investigates the feasibility of EMAs in community palliative care.

Non-professional carers (typically family members) play a critical role in providing adequate home care along with professional caregivers. However, the physical and emotional toll of caring for a family member can lead to distress and burn out of the carer. The latter often results in the need for temporary or permanent institutional care of the patient. This research explores the feasibility of wearable sensors (WS) and electronic patient-reported outcome (ePRO) surveys to monitor activity patterns and stress levels of advanced cancer patient/caregiver dyads in order to understand their needs better.

Throughout the study, wearable sensors are used to passively record physiological data from patient/carer dyads. During wear times, WS recordings trigger ecological momentary assessments (EMAs) conducted via surveys. This pilot investigates the feasibility and acceptability of EMAs in community palliative care and the potential for incorporating EMA-based interventions into routine care. Future studies may explore the possibility of ecological momentary interventions (EMIs) to trigger just-in-time targeted interventions.

Eligibility Criteria:
Inclusion Criteria:

* Palliative care patient attending at Northern Sydney Cancer Centre, RNSH
* Patient and carer dyad
* Both patient and carer consent
* Patient Karnofsky Performance Scale ≥ 50
* Patient and carer have compatible smart phone

Exclusion Criteria:

• Unwilling or unable to give informed consent
Neuroimaging Studies of Smoking and Treatment

The purpose of this research study is to examine changes in brain regions associated with cognitive control and reward processing during behavioral smoking cessation treatment.


Eligibility Criteria:
Inclusion Criteria:

* smoke \> 10 cigarettes per day
* vision is normal or corrected-to-normal

Exclusion Criteria:

* serious medical illness unsuitable for the MR scanner based on best clinical judgment
* any neurologic or psychiatric disorder
* diabetes
* known heart disease
* high blood pressure
* currently taking psychotropic or cardiovascular medication
* history of alcohol or other substance dependence or current abuse
* risk for hazard due to magnetic fields such as metal in the body surgically or accidentally (e.g., pacemaker, cochlear implants, aneurysm clips, intravascular stents or coils, spinal shunt, injury involving bullets, shrapnel or metal implanted in their body, etc)
* pregnancy
NAVIGATE Kidney: A Multi-level Intervention to Reduce Kidney Health Disparities

The overarching goal of this project is to refine and adapt previous work on the NAVIGATE-Kidney project for Latinx with CKD. The investigators hypothesize that the multilevel NAVIGATE-Kidney program intervention will reduce the rate of central venous catheter use at KRT start (primary outcome), increase the rate of optimal KRT starts (secondary outcome), increase patient activation, and reduce decisional conflict (patient-centered outcomes) for Latinx with advanced CKD. The project will have four (4) aims.

The overarching goal of this project is to eliminate structural racism and reduce kidney health disparities faced by Latinx (gender-inclusive term; includes Hispanics, Latino/a/x) individuals. The team developed Navigate-Kidney, a community health worker (CHW) intervention to improve clinical and person-centered outcomes for Latinx with kidney failure receiving maintenance hemodialysis. The investigators now aim to test NAVIGATE-Kidney among individuals with advanced CKD stage 4/5. The investigators hypothesize that compared to standard care, the multilevel NAVIGATE-Kidney intervention will reduce the composite endpoint, defined as (1) time to transition to KRT and central venous catheter use or (2) death (primary outcome), increase the rate of optimal KRT starts and optimal KRT process measures (secondary clinical outcomes), increase patient activation, reduce social challenges, and reduce decisional conflict (patient-centered outcomes) for Latinx with advanced CKD stage 4/5 (eGFR 15-29 mL/min/1.73m2). The investigators will also evaluate Navigate-Kidney implementation outcomes using the PRISM (Practical Robust Implementation and Sustainable Model) science framework and conduct an economic evaluation to inform policy change.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18 years of age,
* Adults who self-identify as Latino/e/a/x and/or Hispanic,
* Adults who are not pregnant,
* Adults who are not incarcerated,
* Adults who have advanced kidney disease with an eGFR of 15-29 mL/min/1.73m2). No other measures are used to identify eligible patients.

Exclusion Criteria:

* Anyone who does not meet the criteria outlined above.
3D Volumetric Changes in the Upper Airway After MMA in OSAS Patients and the Implication on QOL: A Prospective Registry

Background

Obstructive sleep apnea syndrome (OSAS) is a sleep-related breathing disorder characterized by intense snoring and repetitive complete or partial obstructions of the upper airway during sleep together with daytime sleepiness. Several non-invasive therapeutical options exist, however, they do not offer a permanent improvement. Maxillomandibular advancement (MMA) surgery is a procedure which changes the upper airway in a permanent way.

Objectives

The investigators aim to develop a prospective database registering 3D volumetric changes of the upper airway and its anatomic subregions, the apnea-hypopnea index (AHI) and quality of life (QOL) of all consecutive patients eligible for MMA, performed by Dr. Neyt. Patient demographics, detailed virtual cone-beam computed tomography (CBCT) planning parameters, orthognathic surgery, polysomnographic and QOL data are being collected during consecutive visits within the framework of routine practice.

Design

A prospective, observational cohort study

Study center

General Hospital (AZ) Sint-Jan Brugge-Oostende

Population

The investigators would like to include all OSAS patients (AHI ≥ 5) requiring a MMA by Dr. Neyt starting from January 2015.

Endpoints

The investigators aim to collect data that could provide information about the advantages and disadvantages of the routinely performed 3D CBCT preoperative MMA surgery planning for OSAS patients, regarding 3D volumetric changes of the upper airway and its anatomic subregions and quality of life (QOL) in a subjective manner with the Epworth Sleepiness Scale (ESS) and the OSAS questionnaire and in an objective manner with evaluation of the apnea-hypopnea index (AHI).

Duration

In light of the continuous improvement of patient care, a database will be maintained from January 2015 onwards to enable registration of large-scale OSAS patient data.

Conclusions

Development of a database registering 3D CBCT planning, polysomnographic data and quality of life (QOL) of all consecutive patients eligible for MMA, will provide more information about potential patient, virtual planning and surgical factors influencing accuracy of MMA, and the associated biological benefits of this procedure on the upper airway volume, the AHI and general QOL. Moreover, registration of those results could function as a measurement of quality of care, or could be used for sample size calculation for future large multicenter prospective trials.


Eligibility Criteria:
Inclusion Criteria:

* Patients of all ages
* Patients of all genders
* Patients diagnosed with OSAS, based on an AHI ≥ 5
* All consecutive OSAS patients operated by N. Neyt from January 2015 onwards

Exclusion Criteria:

* Patients not eligible according to abovementioned criteria
* Patients with morbid obesity (BMI \>35), if judged non-eligible by the treating surgeon
Change in Stroke Volume Index After Diuresis for Patients With Decompensated Heart Failure

This is a prospective cohort study for 50 patients admitted to the cardiac care unit requiring clinically-indicated diuretic therapy for congestive heart failure. The purpose of this study is to assess the role of non-invasive cardiac output monitoring (NICOM) with the Starling Fluid Management System (Baxter Medical, Deerfield, IL) in determining volume status in patients with acute decompensated heart failure requiring intravenous diuretic therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of congestive acute decompensated heart failure (preserved or reduced ejection fraction) requiring clinically indicated IV diuresis
2. Admission to coronary/cardiac intensive care unit or cardiac step down unit
3. Able to provide written informed consent
4. Anticipated need for IV diuretics \> 24 hrs

Exclusion Criteria:

1. Prisoner, pregnancy or post-partum stage, or age \< 18 years
2. Known allergy to sensory material or gel
3. End stage renal disease or need for CRRT
4. Inability or contraindication to do a passive leg raise with both extremities (i.e., balloon pump, impella, spinal injury, amputation)
5. Other situation that might increase subject risk, interfere with study procedures, or confound study findings based on the opinion of the clinician/investigator
6. Inability to provide informed consent
Malignancies in Transplanted Patients

The aim of the project is to improve the overall treatment and outcome of renal, pancreas or liver transplanted patients who have encountered a malignancy by a structured treatment program for diagnosis and treatment of the malignancy, optimization of the immunosuppressive treatment, follow-up and evaluation of the program.


Eligibility Criteria:
Inclusion Criteria:

* Patients willing and capable of giving written informed consent of participation in the project
* Patients with a previous diagnosed or presently diagnosed or reoccurrence of a malignancy (other then basal cell carcinoma)

Exclusion Criteria:

* Patients with a primary liver cancer as cause of the transplantation
AI in Predicting Polyp Pathology and Endoscopic Classification

Background: Colonoscopy with optical diagnosis based on the appearance of polyps can guide the selection of endoscopic treatment methods, reduce unnecessary polypectomy procedures and the need for tissue pathological diagnosis, and formulate follow-up strategies in a timely manner \[1\]. This approach significantly alleviates the economic burden on patients and the healthcare system and can effectively ease the tension on clinical resources \[2\]. Various endoscopic polyp classification methods, including Pit Pattern \[3\], NICE \[4\], WASP \[5\], and MS \[6\], are used to determine pathological types. However, mastering these classification methods requires endoscopists to undergo extensive training, and due to the inherent flaws in each method, no single endoscopic classification method can accurately diagnose all types of polyps to meet the requirements of optical diagnosis. This limitation has hindered the widespread application of optical diagnosis in clinical practice \[7\]. The application of artificial intelligence technology in this field, known as computer-aided diagnosis (CADx), has seen rapid development in recent years. Numerous large-scale, prospective studies have demonstrated that the accuracy of CADx technology for optical diagnosis of minute lesions (\<5mm) has essentially met the threshold set by European and American endoscopy societies for optical diagnosis \[8,9\]. However, the diagnostic efficacy of CADx for polyps ≥5mm remains unclear. Moreover, current research is mostly limited to distinguishing between common adenomas and hyperplastic polyps, with little attention given to serrated lesions, which are also precancerous lesions and progress even more rapidly, and are more challenging for endoscopists to assess. These reasons prevent CADx from being widely applied in clinical practice for real-time accurate judgment of polyp pathological types.


Eligibility Criteria:
Inclusion Criteria:

1. Outpatients or inpatients undergoing routine colonoscopy screening at the endoscopy centers of multicenter hospitals;
2. Aged 18 years or older;
3. Have understanding of the study content and have signed the informed consent form.

Exclusion Criteria:

1. Gastroparesis or gastric outlet obstruction;
2. Known or suspected intestinal obstruction or perforation;
3. Severe chronic renal failure (creatinine clearance less than 30 mL/minute);
4. Severe congestive heart failure (New York Heart Association Class III or IV);
5. Currently pregnant or breastfeeding;
6. Toxic colitis or megacolon;
7. Poorly controlled hypertension (systolic blood pressure greater than 180 mmHg and/or diastolic blood pressure greater than 100 mmHg);
8. Moderate or massive active gastrointestinal bleeding (\>100 mL/day);
9. Significant psychiatric or psychological illness;
10. Allergy to medications used for bowel preparation;
11. Patients who have undergone colorectal surgery.
Characterization of the Microbiome in Peritoneum, Jejunum, Rectum and Stool

Characterization of the human microbiome in the jejunum and comparison to the microbiome in the rectum and stool in order to see how the microbial communities change within the intestines.

Subjects to undergo surgery with opening of the jejunum will be sampled with sterile swabs from peritoneum and the inside of the jejunum. A swab will also be taken from the rectum.

The peritoneum is regarded as a sterile place until today. We try to either verify this, we also could find a scientific base for theories like leaky gut or other forms of bacterial migration through the intestinal wall.

Many of these patients undergo bariatric surgery. Many of them do have a dramatic change in glucose metabolism immediate after surgery. Therefore stool swabs will be taken before and 5 days after surgery.

Eligibility Criteria:
Inclusion Criteria:

* abdominal surgery containing opening of jejunum
* singing of consent

Exclusion Criteria:

* inflammative condition (appendicitis, pancreatitis, Crohn, Colitis ulcerous, cholecystitis and similar)
EchoTip AcuCore Post-Market Clinical Study

The purpose of collecting this data is to continue to learn more about the EchoTip AcuCore and the device's ability to produce the desired favorable effect and if there are any undesired outcomes that may be related to the EchoTip AcuCore.


Eligibility Criteria:
Inclusion Criteria:

* Patient has been referred for an endoscopic ultrasound (EUS) fine needle biopsy procedure
* The EchoTip AcuCore device is the first EUS biopsy needle used in the procedure.

Exclusion Criteria:

* Patient's age is less than 18 years
* Patient is unable or unwilling to sign and date the informed consent. If IRB approves a waiver of consent, this exclusion criterion is not applicable.
* Patient is simultaneously participating in another pre-market investigational drug or pre-market investigational device study involving an EUS fine needle biopsy procedure and for which the patient has not completed the follow-up phase for the primary endpoint at least 30 days prior to enrollment in this study.
* Inaccessible or unsuitable lesion (lesion not visualized or a large vessel, duct or primary mass interposition)