cyrilzakka/clinical-trials huggingface dataset:
FFR Driven Complete Revascularization Versus Usual Care in NSTEMI Patients and Multivessel Disease

To compare FFR guided complete revascularization during the index procedure with usual care in non-STEMI patients with multivessel disease.

Background:

Patients with non-ST elevation myocardial infarction (non-STEMI), as compared with STEMI patients, have a higher risk profile, more often MVD and less favourable outcome. Recent studies showed that complete revascularization in STEMI patients is feasible and effective. However, there is no clear evidence regarding the role of complete coronary revascularization by PCI in patients with non-STEMI with MVD.

Objective:

To compare FFR guided complete revascularization during the index procedure with usual care in non-STEMI patients with multivessel disease.

Design:

Prospective, multicentre, 1:1 randomized, investigator initiated study.

Hypothesis:

FFR guided complete percutaneous revascularisation of all significant stenosis in the non-culprit lesion performed within the index PCI procedure will improve clinical outcomes compared to the usual care, guided by discretion of the physician.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18-85 years presenting with non-STEMI according to current guidelines, who will be treated with PCI of the culprit and have at least one stenosis of \>50% in a non-IRA on QCA or visual estimation of baseline angiography and judged feasible for treatment with PCI by the operator.
* Non-IRA stenosis amenable for PCI treatment (operator's decision)
* Signed informed consent

Exclusion Criteria:

* Left main disease (stenosis \> 50%)
* Chronic total occlusion of a non-IRA
* Indication for or previous coronary artery bypass grafting
* Uncertain culprit lesion
* Complicated IRA treatment, e.g. extravasation, permanent no re-flow after IRA treatment (TIMI flow 0-1) and inability to implant a stent
* Known severe cardiac valve dysfunction that will require surgery or TAVI in the follow-up period.
* Killip class III or IV during the completion of culprit lesion treatment.
* Life expectancy of \< 1 year.
* Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor or Heparin.
* Gastrointestinal or genitourinary bleeding within the prior 3 months.
* Planned elective surgical procedure necessitating interruption of thienopyridines during the first 6 months post enrolment.
* Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
* Pregnancy
Inflammation After Laparoscopic Robot-assisted Surgery for Locally Advanced Rectal Cancer

The intention of the study is to explore metabolic and inflammatory parameters in the pelvis and systemically after abdominoperineal resection (APR) for locally advanced rectal cancer (LARC) in patients that have received radiation therapy before surgery. In this study the inflammatory response after laparoscopic robot-assisted APR for LARC will be compared to results obtained in a recent cohort of patients operated with open APR for LARC, which will serve as the control population.

Locally advanced rectal cancers (LARC) threaten the normal surgical margins and therefore needs neoadjuvant (chemo-) radiotherapy to down-stage the tumor before surgery. The Norwegian Radium Hospital Oslo University Hospital is a regional center for treatment of LARC in the south-eastern part of Norway and treat approximately 80-100 patients in this category annually. About 50 of these patients receive abdominoperineal resection (APR) as the main surgical treatment.

Laparoscopic surgery in LARC has been limited because of difficult dissection with straight instruments outside the normal anatomical planes in the confined space of the pelvis. However, recent papers report on better feasibility and good results in robot-assisted surgery for LARC. In respect to shorter postoperative length of stay for minimally invasive compared to open surgery, reduced inflammation may be the explanation, however, results are not conclusive. Most studies comparing open to minimally invasive surgery in colorectal cancer have had conventional laparoscopy as the minimally invasive group, including studies comparing inflammation after surgery. A study on inflammation after laparoscopic robot-assisted major surgery for bladder cancer has recently been published, but to our knowledge no comprehensive studies have been done with patients with rectal cancer resections. Additionally, there are claims that excessive and/or dysregulated inflammatory response after cancer surgery, worsen oncologic outcome. The need to characterize the inflammatory response after laparoscopic robot-assisted surgery of rectal cancer is thus highly relevant and needed.

The investigators want to analyse inflammatory parameters in plasma and peritoneal fluid in patients undergoing robot-assisted and open surgery for LARC.

Microdialysis is a technique which enables close to real-time monitoring of the tissues and organs of interest. The investigators want to utilize the microdialysis method to describe and monitor metabolic and inflammatory parameters in some patients after extensive robot-assisted oncological surgery for LARC.

The investigators hypothesize inflammatory response differ between patients undergoing open versus robot-assisted surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients with primary rectal adenocarcinoma that have received radiation ≥25 Gy to the pelvis.
* operation with APR with laparoscopic robot assisted technique.
* have accepted and signed the consent form.

Exclusion Criteria:

* APR for other reasons
Clinical Trial to Evaluate the Efficacy and Safety of EsoDuo Tab. 20/800mg

To Evaluate the Efficacy and Safety of EsoDuo Tab. 20/800mg

A multicenter, randomized, double-blind, active-controlled phase 4 study to evaluate the efficacy and safety of EsoDuo Tab. 20/800mg in patients with non-erosive reflux disease(NERD)

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female aged ≥ 19 years
2. Episode of heartburn for 3 months or more during prior to randomization visit.
3. Episode of heartburn for 2 days or more during the last 7 days prior to randomization visit.
4. Grade N, M by EGD test.

Exclusion Criteria:

1. Surgery history on stomach or esophagus
2. Active medical history of stomach, esophagus area
3. Other system disorder which can disturb this trial
4. Patients taking the contraindication of concomitant medications
5. Clinically significant Abnormal Lab test
6. Pregnant woman, Breastfeeding woman.
Pharmacokinetics of Butyrate Tablet BKR-017

The purpose of this study is to evaluate the pharmacokinetic profile and systemic exposure of BKR-017 in individuals on statin therapy after a single dose and at steady state after seven days repeated twice daily dosing.

BioKier will conduct an open-label study to evaluate the safety and PK profile of BKR-017 in ten hypercholesterolemic (\>100 mg/dL) statin-treated subjects (to reflect the target population), aged 18-70, after a single dose and at steady-state after seven days repeat dosing (Figure 4). On the morning of Study Day 0, subjects will take three tablets (1.5 g of BKR-017), followed by breakfast. Blood samples will be taken for PK analysis at -1, -0.25, 0.5, 1, 2, 4, 6, 8, 10, 12, and 24 hours after dosing. After an overnight stay in the clinic, the 24-hour PK sample will be taken, and subjects will be provided with one week's supply of BKR-017 tablets and a diary for keeping track of tablets taken, instructed to take three 500-mg tablets (1.5 g) BID, and released from the clinic. On Study Day 8, subjects will return to the clinic, and Study Day 0 procedures will be repeated after dose-compliance is confirmed. PK samples will be analyzed by Southern Research using the butyric acid ELISA kit provided by Biomatik (#EKU08762). All regulations will be met according to FDA regulations governing human subject protection and the conduct of clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* Men and women, ages 18-70 inclusive
* Subjects currently on statin treatments.

Exclusion Criteria:

* Presence of cirrhosis, or other causes of liver disease
* Substantial alcohol consumption (\>20 g/day for women or \>30 g/day for men)
* History of bariatric or intestinal surgery
* Active gastrointestinal disease including but not limited to irritable bowel syndrome, inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis), diverticulitis, gastroparesis.
* Active and clinically significant pancreatic disease, or renal disease as determined by the investigator.
* History of heart disease that in the opinion of the investigator should exclude the subject from the study.
* Untreated or uncontrolled hyperthyroidism or hypothyroidism, or other significant thyroid disease
* Active significant infection as determined by the investigator.
* Known allergy to butyrate or any of the components of the tablets.
* Participation in a clinical trial and/or Dosing with an investigational drug during the 30 days before screening, or within 5 half-lives of receipt of an investigational drug or twice the duration of the biological effect of any investigational drug (whichever is longer)
* Pregnant, nursing, or trying to become pregnant.
* In the investigator's judgment, the subject is not suitable for the study for any other reason or cannot commit to the requirements of the study.
* Subject is taking one or more of the excluded therapies or ≥4 drugs in total.
* Taking part in another clinical trial or being in the exclusion period of a previous clinical trial.
The Effects of an Acute High-intensity Exercise on Heart and Brain Function in People with Spinal Cord Injury

The heart and brain are regulated by the autonomic nervous system. Control of these organs can be disrupted in people with spinal cord injury (SCI). This may affect their ability to regulate blood pressure during daily activities and process the high-level information. Previous studies show that high-intensity exercise induces better outcomes on heart and information processing ability in non-injured people compared to moderate-intensity exercise. However, it is unknown the effects of high-intensity exercise on heart and brain function in people with SCI. Therefore, this study aims to examine the effects of a single bout of high-intensity interval training on heart and brain function in this people with SCI compared to age- and sex-matched non-injured controls.

This study will be a cohort control study involving two groups: individuals with SCI, whose level of injury is at the 6th thoracic vertebra or above, and age- and sex-matched controls. Eligible participants will be asked to visit the Laboratory located at 115 Kimball Tower, University at Buffalo South Campus, twice. The first visit takes up to 3 hours, and the second visit takes up to 5 hours.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with a traumatic or non-traumatic spinal cord injury and have ≥4/5 strength in at least one cervical 5 myotome (elbow flexors), allowing to utilize the arm ergometer and level of injury at or above the 6th thoracic vertebra
2. Classified as A, B, C, D (motor and sensory complete or incomplete) on the American Spinal Injury Association (ASIA) Impairment Scale (AIS)
3. Longer than 6 months post the onset of injury and have been discharged to the community from inpatient rehabilitation prior to enrollment
4. English is the first language
5. At least one of the cerebral arteries (i.e., middle cerebral artery and/or posterior cerebral artery) can be found via transcranial Doppler

Exclusion Criteria:

1. Medical conditions that preclude exercise, such as unstable angina, uncontrolled arrhythmias, a recent history of congestive heart failure that has not been evaluated and effectively treated, severe valvular disease, uncontrolled hypertension (i.e., resting systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 105 mmHg)
2. Moderate-severe traumatic brain injury
3. Diabetes
4. Color blindness
5. Pre-existing shoulder injuries
6. Pregnancy
The Effect of Different Feeding Methods on Infants

Objective: The aim of this study was to investigate the effect of finger feeding and syringe feeding methods on infant weight, time to full oral feeding and breastfeeding success in preterm infants.

H01: There is no difference between the weights of preterm babies fed by finger and by syringe.

H02: There is no difference in the transition time between finger-fed and syringe-fed preterm babies to full oral feeding.

H03: There is no difference between breastfeeding success between finger and syringe feeding methods.

The study was conducted as a parallel groups randomized experimental study. The study was conducted between December 1, 2021 and June 1, 2023 in the Neonatal Intensive Care Unit of Aydın Obstetrics and Gynecology Hospital. The sample included preterm infants with 320/7-366/7 gestation weeks who were receiving care and treatment in the neonatal intensive care unit. In the sample, n=38 infants were randomly assigned to study group 1 and n=36 infants to study group 2 and the study was completed with n=74 infants. The data were collected using the Preterm Infant Information Form, Preterm Infant Follow-up Form and LATCH Breastfeeding Diagnostic Measurement Tool. The babies selected for the study group were fed with the method of whichever study group they were added to (finger or syringe feeding) at three feeding meals each day. After switching to full oral feeding, breastfeeding success was measured with the breastfeeding diagnostic measurement tool (LATCH), which was used when the infants first held the breast and the time of transition to full oral feeding. The difference between groups was analyzed using Mann Whitney U analysis for non-normally distributed data and the difference between groups for normally distributed data was analyzed using independent two sample t test. Homogeneity of variances was assessed by Levene's test. Since the standard error indicates the spread of the means of the samples selected from the same population and the standard deviation indicates the distance of each individual in the group from the mean, the standard error values were given together with the means in the analyses comparing the group means.

Eligibility Criteria:
Inclusion Criteria:

* Having a gestational age between 32 weeks and 36+6 weeks,
* Weighing 1500 g or more,
* Having spontaneous breathing (can receive free oxygen, incubator oxygen),
* Those who have been fed only by gavage or parenterally and are ready to switch to oral feeding,
* Preterm babies whose parents were literate in Turkish and gave consent were included in the study.

Exclusion Criteria:

* Those who were fed orally before the research,
* Those who need noninvasive mechanical ventilation such as CPAP,
* Babies with metabolic diseases were excluded from the study.
PF-00477736 Is Being Studied In Advanced Solid Tumors In Combination With Chemotherapy With Gemcitabine

To determine the overall safety of PF-00477736 when given in combination with gemcitabine, a chemotherapy agent, in patients with advanced solid tumors and determine the maximum dose of PF-00477736 that can be safely given in combination with gemcitabine. This is the first study of PF-00477736 in humans.

The study was closed to enrollment as of 17 May 2010 due to business reasons. The patient on study continued treatment until 19 April 2011 when stopped for complete response. Premature closure was not prompted by any safety or efficacy concerns.

Eligibility Criteria:
Inclusion Criteria:

* Histological or cytopathological diagnosis of solid malignancy that is refractory to standard therapy or for which no curative therapy exists.
* ECOG performance status 0 or 1.
* Adequate blood cell counts, kidney function and liver function.

Exclusion Criteria:

* Prior treatment with gemcitabine.
* Uncontrolled brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease.
* NCI CTC Grade 2 or higher ARDS, non-infectious pneumonitis, or pulmonary fibrosis.
* NCI CTC Grade 2 or higher cardiovascular toxicities with the exception of NCI CTC Grade 3 hypertension that is well controlled.
* Known human immunodeficiency virus (HIV) seropositivity.
* Concurrent treatment with anticoagulants or known coagulopathy
Ultrasound-guided Modified Transversus Thoracic Muscle Plane Block and Erector Spinal Muscle Plane Block in Heart Valve Replacement Surgery With Median Incision

Sternum midline incision can offer better view under open-heart surgery and bigger operating space, and therefore it has been widely used in most cardiac surgery. If an event of urgency occurs, it takes on a more important role than infrasternal small incision. However, sternum midline incision may cause serious pain and aggravates stress response, and therefore patients are often reluctant to cooperate to cough which exerts adverse effect on postoperative rehabilitation, and even causes serious complications such as pulmonary inflammation, myocardial infarction and heart failure. Thus, the relief of pain and better perioperative analgesia are very important for these patients. Transversus thoracic muscle plane(TTMP) block and erector spinal muscle plane(ESP) block are used in open heart surgery currently, and they can provide good analgesia. This study aimed to investigate the hemodynamic stability, total amount of analgesic use, perioperative pain, stress response, postoperative complication and recovery in patients receiving TMP and ESP.


Eligibility Criteria:
Inclusion Criteria:

* patients (18-75 years) with BMI at 18-25 kg/m2, ASA Ⅱ- Ⅲ and NYHA Ⅱ-Ⅲ who scheduled to undergo mitral valve or aortic valve replacement surgery.

Exclusion Criteria:

* a second operation, preoperative ejection fraction (EF) \< 40%, complicated coronary heart disease, intra-aortic balloon counterpulsation (IABP) support, psychiatric abnormalities, history of allergy to anesthetic drugs, liver or kidney dysfunction, coagulation abnormality, endocrine system diseases and metabolic diseases.
Effect of Phenazopyridine on Prolapse Surgery Voiding Trials

To determine if phenazopyridine reduces the rate of postoperative urinary retention after pelvic organ prolapse surgery.

Several tools can be used to evaluate for ureteral patency during urogynecologic procedures. Typically, surgeons use urine dyes such as methylene blue, indigotindisulfonate sodium, or phenazopyridine, with the latter being restricted to oral administration. However in June 2014, the two U.S. manufacturers of indigotindisulfonate sodium stopped producing the medication and there is no prospect that it will be returning soon. Phenazopyridine is an over-the-counter medication (Azo-Gesic, Baridium, Urinary Pain Relief) that has been used safely for decades as a bladder analgesic and taints the urine orange.

Over the past few months, increasing evidence suggests that phenazopyridine may reduce transient postoperative urinary retention. Transient urinary retention is common after urogynecologic surgery and is assessed postoperatively by performing a void trial (VT) prior to discharge. In a study designed to determine the time from administration of oral phenazopyridine to visualize dye from the ureters, Propst et al incidentally found that 38% of patients (19 of 49) failed postoperative VTs without phenazopyridine, but only 19% (9 of 47) failed with phenazopyridine, p=0.04. Most recently, a study by Duenas-Garcia et al designed to examine local anesthetics and urinary retention in subjects undergoing midurethral slings found that phenazopyridine decreased the VT failure rate from 30% to 8% (5). The investigators hypothesize that giving a dose of phenazopyridine the morning after surgery will significantly reduce the rate of postoperative urinary retention in women undergoing prolapse repair.

Eligibility Criteria:
Inclusion Criteria:

* Women undergoing overnight admission after prolapse surgery

Exclusion Criteria:

* Unable to provide consent
* Under 18 years of age
* Pregnant women
* Prisoners
* Using intermittent self-catheterization preoperatively
* Neurological disease or spinal cord injury resulting in voiding dysfunction
* Undergoing spinal or epidural anesthesia for the procedure
* Allergy to phenazopyridine
* Renal insufficiency
* Liver disease
* Intra-operative bladder injury necessitating use of prolonged indwelling Foley catheter
Serology After BBIBP-CorV Inactivated Vaccine Combined With BNT62b2 mRNA Booster Vaccine

In this prospective study, SARS-CoV-2 spike protein specific total immunoglobulin (Ig) levels are analyzed before and after BNT162b2 third mRNA booster vaccination in individuals previously administered with two doses of BBIBP-CorV vaccine in comparison to immunized participants with three doses of BNT162b2 vaccination. Questionnaires from recruited participants are reviewed prior to booster vaccination for the occurrence of a previous SARS-CoV-2 infection and hospitalization.

Sixty-one volunteers (39 females, 22 males) vaccinated by BBIBP-CorV were included with the mean age of 63.9 years. To serve as a control group, 61 patients (41 females, 20 males) were vaccinated with BNT162b2 at a mean age of 59.9 years. At least four months after the first two-dose vaccination regimens, both groups received the third booster BNT162b2 vaccine based on the recommendations of the Hungarian Public Health Centre. Total Ig levels against SARS-CoV-2 spike protein 1 receptor-binding domain (anti-SARS-CoV-2 S1-RBD) were measured by an immunoassay (Roche Diagnostics) and their calculated ratios after/before booster dose were compared between the two groups. Vaccination efficacy via incidence of infection and hospitalization was monitored during study period. We found that BNT162b2 can successfully booster the effect of two-dose BBIBP-CorV vaccination to enhance humoral immune response against SARS-CoV-2 infection.

Eligibility Criteria:
Inclusion Criteria: -

Exclusion Criteria: included age \< 18 years, known primary immunodeficiency, malignancy and ongoing immunosuppressive therapy.