cyrilzakka/clinical-trials huggingface dataset:
Effects of Cardiopulmonary Bypass (CPB)-Leukocyte Filtration on Interleukins Serum Levels and Pulmonary Function

To test the hypothesis that leukocyte filtering during cardiopulmonary bypass (CPB) might reduce the inflammatory response and protect the lungs against the acute injury

BACKGROUND AND OBJECTIVES: The extension of the systemic inflammatory response observed after cardiopulmonary bypass (CPB) in cardiac surgery is associated to postoperative pulmonary dysfunction degree. The leukocyte depletion during CPB can modify that response. The aim of this study was to evaluate the effects of leukocyte filtering on the inflammatory response and lung function in patients undergoing coronary artery bypass grafting.

METHODS: After approval by the institutional ethical committee, a prospective randomized study was performed to compare nine patients undergoing coronary artery bypass grafting (CABG) using leukocyte filtration in the arterial line (LG-6, Pall Biomedical Products) and eleven others submitted to standard CPB. Chest CT, oxygenation analysis and a complete leucocyte count were performed before surgery. After intravenous anesthesia induction, patients were mechanically ventilated with tidal volume of 8 mL.kg-1, with FiO2 0.6, and PEEP of 5 cm H2O, except during CPB. Haemodynamic data, PaO2/FiO2, shunt fraction, interleukins, elastase and myeloperoxidase were evaluated before and after CPB, at the end of surgery, 6, 12 and 24 hours after surgery. Chest CT was repeated on the first postoperative day. Data were analyzed using two-factor ANOVA for repeated measures.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing coronary artery bypass grafting (CABG), having their physical state classified as PII and PIII, according to the American Society of Anesthesiologists (ASA). Surgical risk was stratified according to Parsonnet criteria, and only patients considered low to moderate risk were admitted.

Exclusion Criteria:

* Subjects older than 70 years
* Body mass index (BMI) over 35 kg/m2
* Congestive heart failure (CHF) greater than class III (NYHA)
* Left ventricle ejection fraction less than 40%
* Submitted to recent surgery
* creatinine ≥ 1.4 mg / dL or in use of oral anticoagulants were excluded
Patiromer Utility as an Adjunct Treatment in Patients Needing Urgent Hyperkalemia Management

When a patient arrives to an emergency department and is found to have an elevated potassium level in the blood, there is no one standardized treatment, therefore it is not known if one treatment is superior to other. The purpose of this study is to help determine if a drug called patiromer (already approved by the FDA) can help lower potassium levels while patients are in the emergency department.

Given the lack of consistency in hyperkalemia treatment in the ED and the high cost of emergent dialysis, there is a need for the development and systematic evaluation of a treatment protocol to shift potassium into the cells followed by the removal of potassium from the body with a potassium binder.. The present study will use a systematic approach to shifting potassium into the cells followed by binding potassium in the gastrointestinal tract in hyperkalemic patients presenting to the ED. Study subjects will receive patiromer or placebo to determine if patiromer reduces the need for additional medical intervention for the management of hyperkalemia in patients initially treated with IV and inhaled therapy in the ED.

Upon enrollment, patiromer will be administered at a dose selected because of its safety and efficacy shown in a pilot study named REDUCE.

Up to 300 patients will be enrolled and followed for up to 14 days, and potassium levels will be measured at pre-determined intervals to assess drug's impact. concomitant medications will be recorded to help determine if study drug helped, not just lower hyperkalemia, but also decrease the number of total interventions needed to reach a normal potassium level.

Eligibility Criteria:
Inclusion Criteria:

* Hyperkalemia, defined as K+ ≥5.8 obtained via local laboratory or point-of-care testing
* Written informed consent obtained.

Exclusion Criteria:

1. Clinically significant arrhythmia, defined as any arrhythmia requiring ongoing IV antiarrhythmic therapy.
2. Patients who are hemodynamically unstable, defined as mean arterial pressure ≤65 mmHg or heart rate ≤40 beats per minute or ≥125 beats per minute at time of screening
3. Hyperkalemia solely due to overdose on potassium supplements
4. Known bowel obstruction
5. Subjects currently being treated with or having taken potassium binders (e.g., patiromer, sodium or calcium polystyrene sulfonate or sodium zirconium cyclosilicate) in the 7 days prior to baseline
6. Subjects expected to receive dialysis during the first 6 hours of the study treatment period
7. Known hypersensitivity to patiromer or its ingredients
8. Participation in any other investigational device or drug study \<30 days prior to screening, or current treatment with other investigational agent(s)
9. Inability to consume the investigational product or, in the opinion of the Investigator unsuitable for study participation
10. Life expectancy of less than 6 months
11. Patients with automatically timed medication orders to control potassium in the ED
12. Patient is known to be pregnant or breastfeeding
13. An employee of investigational site or sponsors
Antenatal Testing in Obese Woman, is it Really Necessary?

It is well established that obese women are at an increased risk of stillbirth compared to non obese women. This has led many physicians to begin antenatal testing in obese women in the third trimester through either nonstress tests or biophysical profiles. However, there is little evidence that antenatal testing improves fetal outcomes in obese women. The aim of this study is to determine if antenatal testing improves outcomes in obese women and to determine the optimal mode of testing (either nonstress tests or biophysical profiles).

1. Purpose: To determine if antenatal testing improves outcomes in obese pregnant women
2. Rationale: It has been well established that obese pregnant women are at increase risk of stillbirth compared to matched non obese controls. This relative risk is increased not only with increasing gestational age in obese women but with increasing severity of obesity. The increased risk of stillbirth has led some obstetricians to begin antenatal testing in obese women; however, there is little evidence that antenatal fetal surveillance improves outcomes.
3. Study/Project Population: Pregnant women before 32 weeks of gestation with an initial BMI \>30kg/m2
4. Research Design: Randomized Controlled Trial
5. Study/Project Procedures: Patients will be randomized to one of three groups: daily kick counts only, nonstress test, amniotic fluid index, and daily kick counts, and biophysical profile and daily kick counts. These patients will be randomly assigned a group in a 1:1:1 ratio using a random number generator available online. Patients assigned to the daily kick counts only group will be called weekly to ensure they are doing daily kick counts. If they are noncompliant, they will be removed from the study and will undergo nonstress tests if they meet the initial BMI criteria as is the standard practice at our institution.
6. Outcomes Measured: Stillbirth, induction of labor, mode of delivery, neonatal intensive care unit admission, AGPARs \<7 at 5 minutes of life

Eligibility Criteria:
Inclusion Criteria:

less then 32 weeks gestation BMI \> 30kg/m2 English speaking

Exclusion Criteria:

age \< 18 age \>45 medical comorbidity which requires antenatal testing other than obesity unwilling to consent Non-English speaking not pregnant Gestational age \>32 weeks
Oral Protein Supplementation Following Non-bariatric Surgery

Investigators performed a randomized controlled trial of 62 patients undergoing elective abdominal operations. The treatment group was provided a liquid protein supplement and instructed to take a dose three times daily for the first 20 postoperative days. Investigators followed patients for six months and compared wound healing and changes in weight and laboratory values.


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled to undergo abdominal surgery \[cholecystectomy, ventral hernia repair, colectomy, non-bariatric gastric surgery, appendectomy, small bowel resection, lysis of adhesions, liver resection, splenectomy, proctectomy, stoma construction, pancreatic surgery, duodenal surgery, adrenal surgery, renal surgery, or cystectomy\]

Exclusion Criteria:

* Age less than 18 years
* Pregnant
* Abdominal surgery within the past 6 months
* Inability to attend follow-up appointments for at least 6 months
* Liver failure (Child-Pugh Class B or C) or kidney failure (glomerular filtration rate (GFR) less than 30).
Detection of Cervical Lymph Node Metastases With a High-Resolution Positron Emission Tomography (PET) Imaging System

The goal of this clinical research study is to learn if using the PEMFlex Solo II, a high-resolution camera for PET scan imaging, on an area of the body that has, or is suspected to have cancer will give researchers the same or better information about the disease compared to the images taken with a routine PET/CT.

Researchers will compare the images taken using the PEMFlex Solo II to the images taken during your scheduled routine PET/CT scan, as well as any additional routine CT scan(s), magnetic resonance imaging (MRI) scan(s), and/or ultrasound image(s) you may have had within the last 30 days or may have in the next 30 days.

If you agree to take part in this study, right after your already scheduled routine PET/CT scan is complete, a study staff member will take you to a separate imaging room located in the same clinic area where your routine PET/CT scan was just performed.

You will then sit in a chair as a study staff member positions the PEMFlex Solo II on either side of the part of the neck that has, or is suspected to have cancer. It will take about 20 minutes to set up the PEMFlex Solo II and take the PET scan images.

Length of Study:

After the PET scan images have been taken using the PEMFlex Solo II, your participation in this study will be over.

This is an investigational study. The PEMFlex Solo II is commercially available for PET scan imaging of the breast. Using the PEMFlex Solo II for imaging any other parts of the body is investigational.

Up to 10 patients will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. A signed informed consent.
2. Known or suspected primary cancer of the upper aerodigestive tract, which may be determined by biopsy, physical examination- including upper endoscopy or noninvasive imaging studies including CT, MR, ultrasound, or prior PET.
3. Known or suspected metastatic disease to cervical lymph nodes based on physical examination, imaging studies or biopsy.
4. Scheduled for routine clinical imaging at the ACB PET/CT facility.
5. Participant must be at least 18 years of age.

Exclusion Criteria:

1. Prior treatment (chemotherapy, radiotherapy) for cancer of the upper aerodigestive tract.
2. Prior biopsy procedures, including resection of the primary cancer, will not exclude the patient from participation.
3. Uncontrolled blood glucose levels (\>200 mg/dl).
4. Patient is unable to comprehend the requirements of the study.
5. Patient is unable to undergo scanning of the neck with the PEM (PET) scanner (due to body habitus, inability to comply with positioning requirements, etc.).
Carbon-13 Magnetic Resonance Spectroscopy in Glycogen Storage Diseases

The project will use carbon-13 magnetic resonance spectroscopy to assess whether high glycogen levels in skeletal muscle of patients with Glycogen Storage Diseases is a prelude for muscle damage.

Patients with Glycogen Storage Diseases will be examined using carbon-13 MR-spectroscopy to quantify the glycogen levels in lumbar, thigh and calf-muscles. The pattern of glycogen concentration will be compared to the pattern of muscle atrophy found in the literature.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with genetically verified neuromuscular disease or healthy control
* Healthy controls needs to be healthy to be included, evaluated by the investigator

Exclusion Criteria:

* Ferrous objects in or around the body
* Pacemaker or other implanted electronic devices
* Claustrophobia
* Inability to understand the purpose of the trial or corporate for the conduction of the experiments.
* Participation in other trials that may interfere with the results.
* Competing conditions at risk of compromising the results of the study, evaluated by the investigator.
* Strenuous exercise in the preceding 2 days before examination
* Pregnancy or breastfeeding
A Study Comparing Valsartan With And Without Hydrochlorothiazide In Patients With Hypertension

SAFETY EXTENSION STUDY TO THE CORE STUDY CVAH631C2301


Eligibility Criteria:
Inclusion Criteria:

SUCCESSFUL COMPLETION OF STUDY CVAH631C2301

-

Exclusion Criteria:

* NONE
A Study to Assess the Effect of Hepatic Impairment on Safinamide Pharmacokinetics

The primary purpose of this study is to investigate the pharmacokinetics (behavior of the compound in the body) of safinamide in patients with different degrees of hepatic (liver) impairment in comparison to matched subjects with normal hepatic function.


Eligibility Criteria:
Inclusion Criteria:

* Hepatically impaired subjects - Subjects with liver cirrhosis and different degrees of impaired hepatic function: mild and moderate impaired hepatic function (Grade A, or B according to Child-Pugh classification)
* Healthy subjects - Subject is in good age-appropriate physical and mental health as established by medical history, physical examination, ECG and vital signs recordings, and results of biochemistry, haematology, coagulation and urinalysis testing within 3 weeks prior to the dosing
* All subject have given written informed consent before any study-related activities are carried out

Exclusion Criteria:

* Any clinically relevant disease or condition, which in the Investigator's opinion would exclude the subject from the study
* Diseases or surgeries of the gastrointestinal tract, which could influence the gastro-intestinal absorption and/or motility
* Hepatically impaired subjects - Subjects with primary biliary liver cirrhosis, hepatic encephalopathy grade III and IV, sepsis or spontaneous bacterial peritonitis, gastrointestinal bleeding within one month before the study, esophagus varices \> grade II, acute hepatic failure of any aetiology, portosystemic shunt, renal impairment (creatinine clearance \< 50 mL/min calculated by use of Cockroft Gault formula)
* Healthy subjects - Use of any medication, including multi-vitamin preparations, received within 21 days prior to the drug administration, or within six times the elimination half-life, whichever is longest, except combined oral contraceptives and occasional use of paracetamol or ibuprofen within 14 days before study drug administration
Low-dose Neuroleptanalgesia for Postoperative Delirium in Elderly Patients

Postoperative delirium（POD）is a common complication that can directly affect important clinical outcomes, and exert an enormous burden on patients, their families, hospitals, and public resources. In order to evaluate whether an intraoperative administration of low-dose neuroleptanalgesia reduces postoperative delirium, droperidol 1.25 mg and fentanyl 0.025 mg or normal saline is used by intravenous injection 30 minutes before the end of the operation, in elderly patients with non-cardiac major surgery under general anesthesia. The efficiency and safety of neuroleptanalgesia on the incidence of POD would be evaluated in elderly patients.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 65 years old and ≤ 85 years old;
2. Selective non-cardiac major surgery;
3. Informed consent and voluntary participation in the trial;
4. ASA class I-II;
5. Anticipated operation duration ≥ 2 hours;
6. No plan to ICU after operation.

Exclusion Criteria:

1. Neurosurgery;
2. Patients with neurological and mental diseases: such as basal ganglia disease, Parkinson's syndrome, severe central nervous depression, Alzheimer's disease , etc;
3. Patients with prolonged Q-T interval, cardiac repolarization disorder and other severe arrhythmia;
4. Patients with severe cardiopulmonary disease, liver and kidney dysfunction;
5. Allergic or contraindications to droperidol or fentanyl citrate;
6. Admitted to ICU after operation.
7. Operation duration \< 2 hours;
Compression of the Lid Margin Increase Microbial Contamination Risk of Patients Undergoing Cataract Surgery

To investigate whether compression of the lid margin increase microbial contamination risk of patients undergoing cataract surgery


Eligibility Criteria:
Inclusion Criteria:

* (1) Age \> 60 years; (2) clinical diagnosis of age related cataract, without previous recent ocular surgery; (3) undergoing phacoemulsification with implantation of intraocular lens ; (4) able to give informed consent.

Exclusion Criteria:

* (1) any inflammation of the eye or other parts of the body within the previous 3 months; (2) chronic use of any types ophthalmic medication; (3) contact lens wear; (4) ocular surgery within the past 3 months; (5) use of systemic antibiotics within 30 days; (6) use of eyedrops in either eye within 3 days of enrollment; (7) need for concurrent glaucoma, cornea or other surgery.
Factors Associated With Biologic DMARD Switching

The Primary objective of this study is to understand the rheumatoid arthritis (RA) population in national integrated delivery network who are treated with first- or second-line biologic disease modifying anti-rheumatic drug (bDMARD) therapy (with or without Methotrexate) and to evaluate switching patterns and reasons for switching to another bDMARD.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Diagnosis of RA (ICD-9 714.xx) anytime during the study time period of 1/1/2007 to 10/31/2012
* Patients ≥18 years of age at diagnosis date
* Required to have to have 6 months pre-index and 12 months post-index continuous membership and drug benefit eligibility in the database

Exclusion Criteria:

* Patients less than 18 years of age on diagnosis date
* If they had a diagnosis of Crohn's disease, psoriasis, psoriatic arthritis, ulcerative colitis, ankylosing spondylitis, regional enteritis, or anal fistula during the pre-index period
* Patients who had \<7 days supply of adalimumab or etanercept
* Patients currently in a clinical trial during our study
* If patients are in the second-line cohort and have more than 1 prior bDMARD
Thoracic Combined Spinal Epidural Anesthesia for Breast Surgery

The aim of the study is to investigate the efficacy of the thoracic combined spinal epidural anesthesia in breast surgery.

Previous studies of the regional anesthetic techniques such as erector spinae plane block and pectoralis nerve blocks (PECs blocks) additional to general anesthesia have described their use for postoperative analgesia in breast surgery. It has been also reported that these blocks can be used to provide surgical anesthesia in breast surgery . Segmental thoracic epidural anesthesia can be used as an alternative anesthetic technique in patients with severe chronic obstructive pulmonary disease and asthma undergoing breast surgery. It has been also reported that thoracic spinal anesthesia was effective and successful in patients undergoing laparoscopic surgery. In this study, efficacy of high thoracic spinal epidural anesthesia in patients undergoing breast surgery will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients who will be to undergo elective surgery for breast surgery
* American Society of Anesthesiologists (ASA) physical status classification groups I or II

Exclusion Criteria:

* body mass index\>35 kg/m2,
* presence of any condition complicating and contraindicating spinal epidural anesthesia.
Comparison of Beck Depression Score in Multipar and Nulliparous Women Who Have Gone Under Dilatation and Curettage

It is aimed to compare the beck depression and anxiety values of the nulliparous and multipar pregnant women who undergo optional abortion below 12 weeks and to evaluate the effect of the parity on depression and anxiety.

The beck depression and anxiety scale consists of questionnaire questions asked to the patient, and the value on 17 indicates advanced depression.

The BDI inventory has maximum of 63 and minimum of 0 scores:

(0-10): Are considered normal ups and downs (11-16): Mild mood disturbance (17-20): Borderline clinical depression (21-30): Moderate depression, (31-40): Severe depression, Over 40: Extreme depression. A persistent score of !17, requires psychiatric treatment

Eligibility Criteria:
Inclusion Criteria:

* healthy
* Women with a pregnancy less than 12 weeks
* no psychiatric disease or drug use

Exclusion Criteria:

* Those who have had a psychiatric diagnosis before,
* Women under the age of 18,
* Psychiatric drug users,
* Those who have experienced a major trauma or disease
* During the 3-month follow-up period, who developed complications during the procedure pregnant again
* Women with a pregnancy greater than 12 weeks
Clinical Study to Investigate the Safety and Pharmacokinetics of SK3530 Tablet in Renal Impaired Male Patients

This study is designed to investigate the effect of renal impairment on the safety and pharmacokinetics of SK3530 in subjects with renal impairment compared to healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Adult males aged 19 to 64 years at screening.
* Subjects with body weight ≥ 50 kg and within ±30% of the ideal body weight : Ideal body weight = (height \[cm\] - 100)x0.9.
* Subjects who have received and understood completely the information regarding the current study and given written informed consents to voluntarily participate in the study and followed all instructions specified in the protocol.

Exclusion Criteria:

* Subjects with the test results of QTc \> 430 ms or non-sinus cardiac rhythm by ECG analysis.
* Subjects with hypotension or hypertension.
* Subjects deemed ineligible by investigator based on other reasons, including abnormal laboratory values or diseases.