cyrilzakka/clinical-trials huggingface dataset:
Effect of Oral Pregabalin on Hyperalgesia and Post-operative Pain in Patients Undergoing Nephrectomy Surgery: Sex Differential Study

Hyperalgesia is known to be caused by the excitatory amino acid through NMDA receptor. GABA, an inhibitory amino acid, alters the opioid receptor sensitivity against pain resulting hyperalgesia. If the GABA level can be maintained at certain level, the progression into hyperalgesia can be averted. GABA related drugs are known to decrease the postoperative opioid consumption, lower the degree of pain, and prevent hyperalgesia. We hypothesize the effective postoperative pain management and the prevention of hyperalgesia from pregabalin, GABA analogue, and the possible sex difference in such effects of pregabalin.


Eligibility Criteria:
Inclusion Criteria:

* 18, \<51 years

  * healthy patients accepted for video-assisted living donor nephrectomy

Exclusion Criteria:

* Female patients who are pregnant or menopause
* Patients undergoing hormonal therapy
* Patients having neurologic disease or already taking GABA related drugs (pregabalin, gabapentin), or taking opioid drugs
* Insulin resistant diabetes
* Renal deficiency (eGFR \< 60 ml/min/1.73 m2)
* Emergency operation, hemodynamically unstable patients
* Foreigner
* allergic to medication given in this study
A Trial for the Earlier Diagnosis of Inferior Wall STEMI Using a Six-lead Handheld EKG Recorder

The goal of this clinical trial is to compare the result from the a six-leads handheld electrocardiogram (ECG) recorder (KardiaMobile 6L) with those of the standard 12-leads ECG at the patients of acute inferior wall ST-elevation myocardial infarction (STEMI), then ultimately reduce the time it takes to perform re-through treatment according to the faster diagnosis.

Participants with STEMI who visited the emergency room will be recorded 6-leads ECG using KardiaMobile 6L in addition to the standard 12-lads ECG, which is basically performed for all patients of acute coronary syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Among the patients over 19-year-old, patients of ST-elevation myocardial infarction who visit the emergency room and perform emergency coronary angiography or
* Among the patients over 19-year-old, patients who visit outpatient clinics and perform elective coronary angiography for evaluating chest pain

Exclusion Criteria:

* Patients with severe complications of myocardial infarction; cardiogenic shock, respiratory failure and mental change
* Patients who are unable to agree or disagree a written consent
Pilot Bi-Lateral Tubal Occlusion Trial for Female Permanent Contraception

Prospective, multi-center, pilot study evaluating the safety of the FemBloc® Permanent Contraceptive System for female sterilization in preventing pregnancy.

Prospective, multi-center, pilot study of subjects undergoing the FemBloc Permanent Contraceptive System procedure conducted at 5 sites in the U.S. following 49 subjects total. The objective of the trial is to evaluate the safety of the FemBloc Permanent Contraceptive System for female sterilization in preventing pregnancy through the 3-month confirmation test visit. Femasys also intends to continue follow-up of pilot subjects for safety a total duration of approximately 68 months after the FemBloc treatment procedure.

Eligibility Criteria:
Inclusion Criteria:

* Female, 21 - 45 years of age desiring permanent birth control
* Agreement to use temporary birth control (excluding IUC) until documented occlusion
* Sexually active (minimum of 4 coital acts per month) with male partner who is not known or suspected to be sterile
* At low risk for sexually transmitted infection and / or monogamous
* Reasonably certain subject is not pregnant at time of screening and procedure visits
* Willing to accept the risk of pregnancy while relying solely on FemBloc for contraception
* Signs informed consent agreeing to the protocol requirements and is able to meet the trial schedule

Exclusion Criteria:

* Uncertainty about the desire to end fertility
* Suspected or confirmed pregnancy
* Prior tubal surgery
* Uterine anomaly such as unicornuate, bicornuate, arcuate, septate, and didelphic
* Known endometrial or myometrial conditions (e.g. submucous leiomyoma) or uterine position (e.g. retroflexion or anteflexion) that would interfere with insertion tube midline fundal placement, access to uterine cornua, or lateral deployment of the catheters
* Any condition which may prohibit proper visualization of the cervix or not allow the uterus to be appropriately instrumented
* Active or untreated pelvic infection
* Presence or suspicion of gynecologic malignancy
* Any condition or medical treatment (e.g. systemic corticosteroids or chemotherapy) that compromises immune system
* Post-partum or pregnancy termination \<6 weeks of scheduled procedure
* Complicated IUC removal on the day of FemBloc treatment (e.g. use of intracavitary instrument for removal, bleeding, excessive pain)
* Scheduled to undergo concomitant intrauterine procedures at the time of FemBloc treatment or planning any uterine procedure within the 3 months after treatment
* Known hypersensitivity to cyanoacrylate or formaldehyde
* Prior history of ectopic pregnancy
* Abnormal uterine bleeding of unknown etiology
* Any general health condition or systemic disease that may represent, in the Investigator's opinion, a potential increased risk associated with device use or pregnancy, or that would not allow them to complete the trial
Efficacy and Safety of Citrate Anticoagulation in CRRT for Patients With Liver Failure/DysfuncTION, the CAUTION Trial! A Retrospective Study on Etiology of Liver Failure and Their Complications

Study design A retrospective cohort study will be conducted to compare the efficacy and safety of citrate anticoagulation in CRRT among patients with liver failure/dysfunction and severe shock.

Objectives

1. Primary Objective: To determine if the etiology of liver failure impacts the incidence of citrate-related complications in patients undergoing CRRT.
2. Secondary Objectives: To compare the efficacy of citrate anticoagulation in terms of renal recovery, filter lifespan, and patient survival between those with liver failure/dysfunction and severe shock.

Continuous renal replacement therapy (CRRT) is a crucial intervention for managing acute kidney injury (AKI) in critically ill patients. Citrate anticoagulation has become a preferred method in CRRT due to its effect in longer filter longevity and less bleeding compared to unfractionated heparin1. However, its use in specific patient populations, such as those with liver failure or severe shock, necessitates careful evaluation.

Citrate acts as an anticoagulant by chelating calcium, an essential cofactor in the coagulation cascade, thus preventing clot formation within the extracorporeal circuit2. The citrate-calcium complex is then metabolized mainly in the liver, where citrate is converted into bicarbonate, and calcium is released back into the bloodstream. This mechanism provides dual benefits: effective anticoagulation and metabolic alkalization.

Patients with liver failure present unique challenges for citrate anticoagulation. Impaired liver function can lead to the accumulation of citrate, resulting in high anion gap metabolic acidosis and hypocalcemia3. These risks underscore the need for vigilant monitoring and potential adjustment of citrate dosing in this population. The aim of the present study is to explore whether the etiology of liver failure, which can range from alcoholic liver disease to drug-induced liver injury or shock liver, influences the incidence and severity of citrate-related complications.

Eligibility Criteria:
Inclusion Criteria:

* Critically ill patients diagnosed with AKI requiring CRRT. Caution Protocol V1.0 24-07-2024
* Documented liver failure or significant liver dysfunction (e.g., elevated liver enzymes, bilirubin levels, or clinical diagnosis of liver failure) and clincal diagnosis of shock (NE of 0.25 μg/kg/min and or association of second vasopressor).
* Age ≥ 18 years.

Exclusion Criteria:

* NA
Effects of Mediterranean Diet and Naltrexone/Bupropion Treatment in Obese Breast Cancer Patients

Obesity among breast cancer survivors is known to be associated with recurrence and other co-morbidities. However, there have been no studies on weight reduction program combining diet and anti-obesity drug for obese breast cancer survivors. The purpose of this randomized clinical trial is to examine the effects of Mediterranean Diet and naltrexone/bupropion treatment on inflammation and metabolic risk factors in overweight or obese breast cancer patients after breast cancer treatment.


Eligibility Criteria:
Inclusion Criteria:

* Female, 20 to 65 years of age
* Diagnosed with breast cancer stage Ⅰ-Ⅲ, and have completed cancer treatment including breast surgery and/or adjuvant chemotherapy, radiotherapy, hormonal therapy
* BMI ≥25 kg/m2, or BMI ≥23 kg/m2 with one or more of the metabolic risk factors (waist circumference ≥80 cm, fasting glucose ≥100 mg/dL, BP ≥130/85 mmHg, HDL-cholesterol \<50 mg/dL or controlled diabetes, hypertension, dyslipidemia with medications)
* If woman of child bearing potential, agree to use effective contraception throughout the study period and 30 days after discontinuation of study drug
* Able to speak and read Korean
* Able to comply with all required study procedures and schedule
* Willing and able to give written informed consent

Exclusion Criteria:

* Participants with cancer recurrence or metastasis
* Participants with uncontrolled hypertension (systolic blood pressure (SBP) \>180 mmHg, or diastolic blood pressure (DBP) \>120 mmHg)
* Participants with hepatic disease (aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \>3 x institutional upper limit of normal) or renal disease (serum creatinine \>2.0 mg/dL)
* Participants with significant cardiovascular disease or stroke
* Participants with history of seizures
* Participants with serious psychiatric illness, including bipolar disorder, schizophrenia, or other psychosis, bulimia, anorexia nervosa, or suicidal ideation
* Participants who are taking medications such as monoamine oxidase (MAO) inhibitors, opioid-containing medications, other naltrexone or bupropion containing medications, and Tamoxifen
* Current smokers or use of nicotine replacement products in the previous 6 months
* Pregnant or breast-feeding women
* Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in this study
Shear Wave Elastography in Native Kidney Disease

In this proposal, the aim is to examine shear wave elastography (SWE) measurements in diseased native kidneys and correlate them with grades of fibrosis using histological samples.

The overall goals of the proposed study are addressed by the following specific aim.

Specific aim: To determine whether differences exist in elasticity measurements between native kidneys with and without fibrosis.

Hypothesis: Kidneys with higher grades of fibrosis will demonstrate higher measures of tissue elasticity and stiffness compared to kidneys with zero fibrosis.

The proposed project is a prospective cross-sectional study correlating native kidney shear wave elastography (SWE) measurements with histology. Briefly, patients referred for a native kidney biopsy will undergo SWE and the shear wave velocity (SWV) will be correlated with degree of fibrosis determined by a pathologist.

A list of patients who recently underwent a native kidney biopsy will be obtained from the pathology department on a weekly basis. Patients will then be contacted about participating in the study and consented during a follow up visit with their nephrologist.

After their biopsies, patients will be scheduled to come for a renal ultrasound and SWE. SWE examination will be conducted using an ultrasound machine equipped with a Philips Epiq ARFI Shear wave ElastPQ C1-5 mHz transducer. Shear wave velocity will be obtained and an estimate of tissue elasticity (Young's modulus) will be calculated. All measurements will be performed by one of two qualified radiology physicians who will be blinded to the clinical and pathological data. We will allow a period of 90 days to obtain the images after the biopsy; otherwise the patient is no longer eligible to participate.

The primary outcome measure of this study is to determine whether tissue elasticity determined by SWE can assess kidney fibrosis. Linear regression analysis will be performed to describe the relation of the extent of fibrosis and parenchymal stiffness.

Eligibility Criteria:
Inclusion Criteria:

* All patients over 18 years of age who are referred for a native kidney biopsy.

Exclusion Criteria:

* BMI \> 35
* Patients with polycystic kidney disease, renal cell carcinoma, hydronephrosis or renal stones.
* Patients who develop severe post biopsy complications (infection, significant bleeding requiring transfusion or intervention)
* Pregnant patients.
Hemoglobin, Neutrophil to Lymphocyte Ratio and Platelet Count Improve Prognosis Prediction in Nasopharyngeal Carcinoma

RATIONALE

1. In patients with nasopharyngeal carcinoma, there is sometimes a discrepancy between actual clinical outcome and TNM stages because it is an anatomy-based system in which functional factors are not concerned.
2. Hemoglobin, neutrophil to lymphocyte ratio and platelet count were proved to improve prognosis prediction of TNM staging system in our previous retrospective study.

PURPOSE To validate that the prognostic index based on complete blood count and TNM system had higher prediction efficiency on survival in nasopharyngeal carcinoma than TNM system alone.

Totally 720 patients with non-metastatic nasopharyngeal carcinoma will be include and will be divided into 3 groups (Low Risk, Intermediate Risk and High Risk Groups) according to their prognostic index, which is on basis of blood cell count indexes and TNM stage. The 3 groups of patients will undergo a radical radiotherapy or chemoradiotherapy and be followed until death or the end of the study. Comparison on survivals of the 3 groups will be made to validate the accuracy of the prognostic index. And comparison on prediction efficacy between prognostic index and TNM staging system will be made.

Eligibility Criteria:
Inclusion Criteria:

* Nasopharyngeal cancer patients diagnosed by pathology or cytology
* UICC/AJCC 2010 Stage T1-4 N0-3 M0
* Male or female patients with age between 18 and 75 years old
* Karnofsky Performance Scores ≥ 60
* Expected survival ≥ 3 months
* Without dysfunction of heart, lung, liver, kidney and hematopoiesis

Exclusion Criteria:

* Karnofsky Performance Status Score \< 70'
* Radiotherapy uncompleted (≥ 1 fraction missing)
* Distant metastases before or during radiotherapy
* Without weekly complete blood count during radiotherapy
* Application of colony stimulating factor such as erythropoietin
* Signs of infection before radiotherapy.
Multiregional rtfMRI Neurofeedback for the Prevention of Alzheimer's Disease (NPAD)

This study aims to predict cognitive decline using a performance endophenotype of neuro-feedback based on functional magnetic resonance imaging in real time in a population at risk for Alzheimer's disease (AD).

In this research project, a longitudinal study in a healthy population that is under increased risk of developing AD will be performed. It is anticipated that some of the participating subjects will develop episodic memory decline within this longitudinal follow-up. The memory binding Test (MBT) and/or the Free and Cued Selective Reminding Test (FCSRT), the most accurate and reliable available episodic memory tests, are going to be performed by the subjects at multiple longitudinal data collection points. The project proposes to develop a real-time functional magnetic resonance imaging (rtfMRI) task, and to test whether the subjects' performance on the task can predict the apparition of cognitive decline. The impact of other relevant biomarkers by adding them to the model: age, gender, number of APOE-e4 alleles, cognitive scores, cerebrospinal fluid (CSF) biomarkers, amyloid Positron Emission Tomography (PET), lifestyle habits and clinical background will be studied.

Eligibility Criteria:
Inclusion Criteria:

* Adult men and women (aged 45-75) that have participated in the study 45-65/FPM2012.
* Persons that accept the study's test and procedures that are as follows: magnetic resonance imaging and neuropsychological tests.
* Signature of the study's informed consent form, accepting to not receive information with regards to any research results that are not clinically relevant.

Exclusion Criteria:

* Any contraindication to MRI (e.g. pacemaker, claustrophobia, etc.)
* Any condition that according to the investigator's judgement could interfere with the proper execution of the study's procedures and/or its follow-up.
Studies to Gain Insight How the Drugs PCSK9-inhibitors and Statins Affect Cholesterol and Bile Acid Metabolism

Eight healthy male volunteers will be studied in consecutive sessions regarding the acute effect of evolocumab and atorvastatin on cholesterol and bile metabolism.


Eligibility Criteria:
Inclusion Criteria:

* Male
* \>18 years of age

Exclusion Criteria:

* Cardiovascular disease
* Cerebrovascular disease (e.g. stroke, prior aneurysm)
* Pulmonary disease (e.g. pulmonary hypertension, COPD)
* Metabolic disease (incl. but not limited to Cushing disease, Diabetes)
* Renal disease (by Chronic kidney disease criteria)
* Active inflammatory bowel syndrome
* Cancer
* Pregnancy
* Smoker
* Any chronic medication use
* Steroid treatment for the last six months or hormone replacement therapy
* Coagulopathy
* Musculoskeletal or neurologic disease
* Know allergy against any of the studied substances
* Inclusion in any other concurrent medical research study
The Impact of Implementing NIDCAP on Preterm Infants in the NICU

The purpose of this study is to evaluate the impact of the NIDCAP program of individualized patient consultation on the neurobehavioral organization of transported preterm infants in the NICU. Behavioral response to routine caregiving will be compared between infants in the pre-NIDCAP group to infants in the post-NIDCAP group. And it is this behavioral response that will be used to evaluate the effectiveness of the NIDCAP program.

Therapies that have brought about sharp decreases in neonatal mortality have not brought about similar decreases in neurodevelopmental morbidity for preterm infants. Developmentally supportive care is NICU care that seeks to optimize the developmental course and outcomes for preterm infants. While other staff training programs for developmentally supportive care exist, it is the Newborn Developmental Care and Assessment Program (NIDCAP) that has been the methodology used in randomly controlled trials that demonstrate positive medical and neurobehavioral outcomes for preterm infants receiving developmentally supportive care. NICUs that care for all out-born or transported infants face unique challenges in balancing developmentally supportive nursing care with the high-technological medical needs of the most critically ill and extremely premature infants. Yet it is these most fragile infants who can most benefit from the positive impact the NIDCAP program can offer. Yet, there are no published studies documenting the impact of the NIDCAP program on neurobehavioral outcomes of these transported preterm infants exclusively.

Objectives: The objective of this project is to study the impact of implementing the NIDCAP program of individualized patient consultation on the neurobehavioral organization of transported preterm infants in the NICU of a major pediatric medical center.

Research Methods: A random sample of approximately 40 preterm infants will be recruited to participate in this descriptive study. In this phase-lag design, 20 infants will participate in the pre-NIDCAP intervention phase and 20 infants will participate in the post-NIDCAP intervention phase. Each infant within each phase will be videotaped during 2 routine nurse-caregiving sessions. The first session will occur within 72 hours of admission to the NICU at Children's Memorial Hospital (CMH). The second session will occur when the infant is 34-36 weeks corrected gestational age. The videotapes will be collected so that observations of the infant's physical environment and caregiving and an assessment of the infant's behavioral function can be scored randomly at the end of the study by an outside consultant without bias as to what phase the infant participated. In addition, demographic data will be collected on the sample infants. Data will be subjected to descriptive statistics, inferential statistics and correlational procedures.

Eligibility Criteria:
Inclusion Criteria:

* preterm infants born at less than or equal to 32 weeks gestation, appropriate for gestational age in weight

Exclusion Criteria:

* congenital or chromosomal abnormality, history of maternal substance abuse
Prospective Clinical Study of the Levita Magnetics Surgical System Used for Prostatectomy Surgery

The purpose of this study is to evaluate the safety and effectiveness of the Levita Magnetic Surgical System in patients undergoing prostatectomy surgery.

Prospective, multicenter, single-arm, open label study designed to assess the safety and effectiveness of the Levita Magnetic Surgical System in prostatectomy surgery.

Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 18 years of age
* Subject is scheduled to undergo elective prostatectomy surgery

Exclusion Criteria:

* Significant comorbidities
* Subjects with pacemakers, defibrillators, or other electromedical implants
* Subjects with ferromagnetic implants
* Clinical history of impaired coagulation
* Subject has an anatomical abnormality noted after initiation of index procedure that would prevent device use
* Subject is not likely to comply with the follow-up evaluation schedule
* Subject is participating in another clinical trial
COVID-19: Safety and Immunogenicity of a Reduced Dose of the BioNTech/Pfizer BNT162b2 Vaccine

This is a randomized phase IV dose-optimization study evaluating the safety and immunogenicity of two doses of COVID-19 mRNA vaccines being authorized in the European Union since December 2020: Vaccine BNT162b2 (Comirnaty®; Pfizer-BioNTech) in healthy adults up to age 55 year. Immunogenicity will be measured 28 days after first and second dose, and day 180 and day 365 after first vaccination of 20 and 30 mcg of BNT162b2. The primary outcome is the level of binding antibodies for RBD 28 days after the second dose.

Background: Data from the dose-escalating phase 1 trials from the COVID-19 mRNA vaccines being authorized in the European Union since December 2020, BNT162b2 (Comirnaty®; Pfizer- BioNTech) indicate that for the age group 18-55 years a lower dose of the vaccine can induce the same immune response as the full dose.

Method: This is a randomized multicenter phase IV dose-optimization study evaluating the safety and immunogenicity of demi-doses of a COVID-19 mRNA vaccine being authorized in the European Union since December 2020, BNT162b2 (Comirnaty®; Pfizer- BioNTech) in healthy adults up to age 55 year. The study will be performed in employees of Mensura EDPB at five different sites.

Objectives: The primary outcome is the level of binding antibodies for RBD 28 days after the second dose. Secondary outcomes are safety and reactogenicity after vaccination. The neutralizing antibodies and the cellular immunity 28 days after second dose will be assessed. Humoral and cellular immunity will be measured 180 and 365 days after first dose.

Eligibility Criteria:
Inclusion Criteria: Working at Mensura EDPB, not yet vaccinated for COVID19 -

Exclusion Criteria:

-