cyrilzakka/clinical-trials huggingface dataset:
A Trial Comparing Quadratus Lumborum Block (QLB) and Paravertebral Block (PVTB) for Postoperative Analgesia in Hepatectomy

Pain after hepatectomy can interfere with the patients' recovery and may contribute to developing long term pain. Opioids, e.g. morphine, fentanyl, sufentanil, works well for postoperative analgesia, but have several side effects such as nausea, vomiting and itching which may be severe enough to affect patients' recovery. In some cases, opioids may cause constipation and urinary retention within the first 24 hours after surgery. Thus, several ultrasound-guided nerve block procedures have been applied to provide postoperative analgesia. Ultrasound-guided thoracic paravertebral block (TPVB) is one of the most used nerve block methods using for post-hepatectomy analgesia. However, in some cases, ultrasound-guided TPVB can cause pneumothorax, hemopneumothorax, and higher block level. The quadratus lumborum block (QLB) is a new developed nerve block which can provide a widespread analgesic effect from T7 to L1. Therefore, this study is to determine whether QLB or TPVB have a better pain control with fewer side effects and complications after laparoscopic and open hepatectomy. The adequate pain control will be assessed by their visual analogue score (VAS) and the postoperative quality of recovery scale (QoR-15, Chinese Version). Additionally, the side effect and complications profile of these two nerve block techniques will also be recorded and compared.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 65 years old for selective hepatectomy from nanfang Hospital, Southern Medical University
* American Society of Anesthesiologists (ASA) risk class I-III;
* Body Mass Index (BMI) is not lesser than 18 and not greater than 30;

Exclusion Criteria:

* Patients refuse to participate
* Allergy to the any agents used in current clinical trial;
* Dependence, tolerance or excessive sensitivity to the anesthetics and psychotropic drugs;
* Patients with nerve block contraindications (e.g. local infection of skin or soft tissue in injection site, serious bleeding tendency or hemorrhagic disease, anatomical aberration which make anesthesiologist cannot perform the ultrasound-guided nerve block, allergic history of local anesthetics, etc.);
* Previous abdominal surgery (except for diagnostic biopsy);
* New York Heart Association (NYHA) classification of cardiac function grade IV and/or Ejection Fraction (EF)≤55%;
* Child-Pugh grading
* Liver function of grade C (Child-Pugh grading)
* Glomerular filtration rate≤60ml/min/1.73m2;
* Obstructive sleep apnea syndrome;
* Chronic obstructive pulmonary disease, asthma, active tuberculosis;
* Cardiac rhythm disorders;
* Past or present history of nervous system diseases and mental disorders (such as epilepsy, Alzheimer's disease, Parkinsonism syndrome, depression,etc.);
* Autoimmune diseases (such as lupus erythematosus, rheumatoid arthritis,etc.)
* Malignant tumors of other systems;
* Other operations are required during the same period;
Intra-articular Polyacrylamide Hydrogel in the Treatment of Knee Osteoarthritis

1-year follow-up of a randomized controlled trial with open-label extension to assess the long-term efficacy and safety of Intra-articular HBISA Endoprosthesis of Synovial Fluid NOLTREX™ in Knee Osteoarthritis.

HBISA (polyacrylamide hydrogel) endoprosthesis of synovial fluid NOLTREX™ is intended for the symptomatic treatment of adult patients with osteoarthritis (OA) reducing pain and improving mobility.

The aim of this 1-year follow-up was to evaluate the long-term safety and efficacy of IA Polyacrylamide hydrogel with silver ions in patients with Kellgren-Lawrence grade 3 and 4 knee osteoarthritis who had received one or two treatment courses in the IA/PAAG-SI/OA/2019 and IA/PAAG-SI/OA/2020 studies.

Follow-up data were collected in telephone interviewing (using questionnaire) in April-July 2022, 12 months after the completion of OLE (IA/PAAG-SI/OA/2020).

Eligibility Criteria:
Inclusion criteria:

The study included patients with KL grade 2-3 knee osteoarthritis who had completed study IA/PAAG-SI/OA/2019 and IA/PAAG-SI/OA/2020.

Exclusion criteria:

Declining participation in the survey Lost to follow-up
Genderspecific Differences in Hormone Levels After Trauma

The goal of this prospective study with the aim to establish a registry is to learn about the role of steroid hormones in severely injured patients. The main question it aims to answer is whether steroid hormones influence morbidity and mortality after severe trauma.

This is a prospective study with the aim to establish a large registry for severely injured patients and their hormonal status.

Hormone levels will be measured upon arrival in the emergency room and within the following few days after trauma. Furthermore a detailed questionnaire aims to answer any hormone-related health questions.


Eligibility Criteria:
Inclusion Criteria:

* Polytrauma with ISS≥16,
* severe traumatic brain injury (AIS ≥3)
* over the age of 18
* must reach emergency room alive

Exclusion Criteria:

* pregnant patients
* dead on arrival to the hospital
* incarcerated patients
* secondarily transferred patients
Evaluation of Interest of LUMEEN Virtual Reality Headset to Reduce Preoperative Anxiety in AMBulatory Surgery

This study evaluate the interest of Virtual Reality to reduce the preoperative anxiety in patients who undergo to ambulatory surgery. Half of the patients will received the virtual reality program, and the other half will received de common treatment.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-II (classification of the American Society of Anesthesiologists).
* Ambulatory surgery scheduled
* Score STAI YA \> 45
* Affiliated to a social security
* Understanding the study and signing the informed consent

Exclusion Criteria:

* Contraindications for Midazolam
* Patients with disorders not compatible with virtual reality: severe cognitive or psychiatric disorders, blindness, claustrophobia, epilepsy
* Patient with a pacemaker of others implantable medical devices
* patient with burns or wounds on the upper face or scalp
* Visual hallucinations
* Contagious disease by air or indirect contact
* Person unable to express their consent
* Minor patient or patient under curatorship or guardianship
* patient participating in another interventional clinical trial
Extension Study of IDEAL (Imatinib) for Chronic Myelgenous Leukemia (CML)

This study is an extension study (prospective observational study) of 'IDEAL' study (A Study to Evaluate Efficacy and Safety of Imatinib (Glinib) 600mg/day depending on Early Molecular Response in Newly Diagnosed Patients with Chronic Myeloid Leukemia in Chronic Phase, NCT02204722) to evaluate the duration of treatment response, disease progression, and survival status up to 5 years after the inclusion.

We have started a prospective study of evaluating efficacy and safety of imatinib 600mg/day depending on early molecular response in newly diagnosed patients with chronic myelogenous leukemia in chronic phase (IDEAL, NCT02204722), which will enroll 150 patients and follow up them for 1 years for the purpose of evaluating the primary endpoints - difference of major molecular response rate at 1 year. However, Chronic myelogenous is a disease which needs long-term for the outcome of treatment with BCR-ABL tyrosine kinase inhibitor. After the end of follow-up period of IDEAL study, subjects who agree with this extension study (IDEAL-E) will be enrolled and be followed up for additional 4 years to evaluate the duration of treatment response, disease progression, and survival status. Subjects who will be enrolled in this prospective observational study will be treated with drugs - imatinib 300-600mg / nilotinib 600mg / dasatinib 100mg - which has been chosen by the each investigator according to the drug compliance and overall response. The drug choice will be at the discretion of each investigator, and the overall adverse event / molecular response will be monitored every 6 months in this prospective observational study.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were newly diagnosed as chronic phase chronic myelogenous leukemia, were enrolled to 'IDEAL study (A Phase IV Study to Evaluate Efficacy and Safety of Imatinib(Glinib®) 600mg/day Depending on Early Molecular Response in Newly Diagnosed Patients with Chronic Myeloid Leukemia in Chronic Phase, NCT02204722)
* Subjects who agreed with the participation of this study after informed consent

Exclusion Criteria:

* Patients who were newly diagnosed as chronic phase chronic myelogenous leukemia, agree with the participation to 'IDEAL study (A Phase IV Study to Evaluate Efficacy and Safety of Imatinib(Glinib®) 600mg/day Depending on Early Molecular Response in Newly Diagnosed Patients with Chronic Myeloid Leukemia in Chronic Phase, NCT02204722) after informed consent, but were excluded finally from the 'IDEAL' study
Tissue Bank of Biological Specimens From Patients With Gynecologic Disease

The purpose of this study is to create a tissue bank of gynecologic cancers and normal tissue for the study of cancer in order to better understand the changes occurring on a molecular level (DNA, RNA, protein) that lead to the development of cancer.

Cancer arises due to genetic alterations that disrupt numerous cellular functions including proliferation, programmed cell death and senescence, that ultimately control the number of cells in a population. The genetic damage that underlies the development of cancers has a diverse etiology and loss of DNA repair mechanisms also may play a role in allowing mutations to accumulate. Cancers are also characterized by the ability to invade surrounding tissues and to metastasize. Many of the molecular alterations involved in this process have yet to be elucidated.

Gynecologic cancers afflict women of all ages. Cervical cancer is the most common gynecologic malignancy worldwide, accounting for over 400,000 cases annually. Endometrial cancer is the most common gynecologic malignancy with approximately 33,000 new cases being diagnosed annually in American women. Ovarian cancer is the fourth most common cause of cancer related mortality in American women, with approximately 14,000 deaths occurring from it in 2000.

The creation of a tissue repository containing tissue specimens, blood/serum, and molecular extracts (DNA, RNA, protein) will provide a rich source of tissue for future gynecological disease research studies.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo surgery for diagnosis and treatment of a gynecologic disease at one of the participating institutions
* \> = 18 years old
* Ability to read English

Exclusion Criteria:

* \< 18 years old
Effect of Plant Sterols Esterified to Fish Oil Fatty Acids on Plasma Lipid Levels

The purpose of this study is to determine whether plant sterols esterified to fish oil fatty acids in a fish oil matrix improve the lipid profile, predominantly LDL-cholesterol and TG concentrations in healthy hyperlipidemic subjects.

Phytosterols and omega-3 fatty acids (n-3) are natural food ingredients with potential cardiovascular (CVD) benefits. Phytosterols inhibit dietary cholesterol absorption and biliary cholesterol re-absorption, thereby reducing blood cholesterol levels, while consumption of n-3 is associated with a significant reduction in plasma triglyceride concentrations. Furthermore, n-3 may also beneficially modify a number of other risk factors of CHD, like anti-inflammatory and anti-thrombotic.

The primary objective of this study is to determine whether plant sterols esterified to fish oil fatty acids in a fish oil matrix improve the lipid profile, predominantly LDL-cholesterol and TG concentrations in healthy hyperlipidemic subjects. In addition the supplement efficacy to lower other CVD-related risk factors of healthy will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, \>18 years old and ≤ 70 years old, capable and willing to give written informed consent.
* Subject must have hyperlipidemia at the screening visit and at the end of the run-in period, defined as: fasting plasma triglycerides \> 150 mg/dl and \< 500 mg/dl, LDL-cholesterol \> 130 mg/dl and \< 190 mg/dl.
* Fasting plasma glucose (FPG) levels at the screening visit \< 110 mg/dl.
* Female patient who is of reproductive potential agree to use acceptable methods of birth control
* Female patient who is currently receiving hormone replacement therapy continuously 12 weeks before visit 1 (on stable dose) and will agree to do so during the study.

Exclusion Criteria:

* Receiving medications or supplements known to affect lipid metabolism.
* Uncontrolled hypertension or thyroid disease.
* Consume unusual diets - will be determined at the discretion of the investigator.
* Gained or lost more than 3 kg during the run-in period.
* Patient has history of malignancy ≤ 5 years.
* Patients with clinical ischemic CV disease on treatment
* Consume 200 grams fish x 2 a week.
* Gastrointestinal disease or any disease that the investigator feels would compromise the patient safety or limit his/her successful participation to the study.
* Patient has type 1 or type 2 diabetes mellitus.
* Patient has uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins
* Patient has had active peptic ulcer disease within 3 months of visit 1.
* Woman patient is pregnant or breast-feeding or expecting to conceive during the study.
* Patient has a history of hypersensitivity or allergy to fish, fish oil, corn oil or soy.
Evaluation of the Program SI! for Preschool Education: A School-Based Randomized Controlled Trial

Cardiovascular disease continues to be the principal cause of death in the world. At present, the risk factors for cardiovascular disease continue to appear at an earlier age permitting prevention activities and the promotion of healthy habits to focus on children. Numerous studies have shown that these factors can be controlled in children through school-based interventions. At the same time, data shows that there is a persistence of unhealthy lifestyles (ie sedentary lifestyles, the use of tobacco, etc...) that begin in childhood and are perpetuated until adulthood. Therefore, the acquisition of healthy lifestyles should begin as early as possible. The SI Program for Preschool Education is an intervention that is both school and home based designed to improve the habits, knowledge and attitudes in four key areas: Food (diet), Physical Activity, Knowledge of the Body and Managing Emotions. This intervention will be implemented in children from three to five years of age, in their parents and in their teachers. To evaluate the efficacy of this intervention, the principal aim of the phase of evaluations is to quantify the behavior changes in the three groups/populations mentioned. The evaluation has been designed according to the controlled intervention model, in which twenty-four schools from the Community of Madrid will be randomized to implement the Program si! for Preschool Education or to function as control schools.


Eligibility Criteria:
Inclusion Criteria:

* The schools must be located within the municipality of Madrid
* The schools must be public
* The schools must have, at the least, two classes for Preschool Education, for children 3, 4 and 5 years of age
* The schools must make available the use of the cafeteria.

Exclusion Criteria:

* NA
Using Digital Health Technologies to Prevent Rapid Infant Weight Gain.

A digital intervention to provide supplemental infant feeding support to mothers enrolled in WIC. The trial begins prenatally and continues through 3-months postpartum and tests the feasibility and acceptability of a text messaging intervention aimed at increasing responsive bottle feeding as well as breastfeeding duration and exclusivity among mothers enrolled in WIC using evidence-based components such as interactive self-monitoring and feedback.

Recruitment and enrollment never started at Duke for the Intervention represented in this record. The overall status of recruiting and actual start date were previously entered in error.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled in WIC, English or Spanish speaking, at least 18 years old, between 18-28 weeks' gestation, and planning to remain enrolled in WIC for 6 months, intention to breastfeed or undecided about breastfeeding, and willingness to send and receive daily text messages.

Exclusion Criteria:

* Postpartum exclusions include infant prematurity (\<37 weeks), \>3 days in neonatal intensive care unit, major medical problem affecting breastfeeding (i.e., maternal HIV), or birth weight \<5 lbs.
Histocompatibility Leukocyte Antigen (HLA)-A*2402 Restricted Peptide Vaccine Therapy in Patients With Breast Cancer

The purpose of this study is to evaluate the safety and time to progression of HLA-A\*2402 restricted epitope peptide TTK emulsified with Montanide ISA 51.

TTK has been identified as cancer specific molecules especially in breast cancer using genome-wide expression profile analysis by cDNA microarray technique. We have determined the HLA-A\*2402 restricted epitope peptide derived from this molecule and identified that this peptide significantly induces the effective tumor specific CTL response in vitro and vivo. According to these findings, in this trial, we evaluate the safety, immunological and clinical response of that peptide. Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, TTK-A24-567 peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection. Repeated cycles of vaccine will be administered until patients develop progressive disease or unacceptable toxicity, whichever occurs first. In the phase I study, we evaluate the safety and tolerability of this peptide vaccine. In the following phase II study, we evaluate the immunological and clinical response of this vaccine therapy.

Eligibility Criteria:
Inclusion Criteria:

* Advanced or recurrent breast cancer
* Resistant against anthracycline-based and taxane-based chemotherapy or difficult to continue the chemotherapy due to intolerable side effect(s)
* Resistant against trastuzumab or difficult to continue it due to intolerable side effect(s) when her-2 is positive
* ECOG performance status 0-2
* Life expectancy \> 3 months
* HLA-A\*2402
* Laboratory values as follows

  * 2000/mm3\<WBC\<15000/mm3
  * Platelet count\>100000/mm3
  * Bilirubin \< 3.0mg/dl
  * Asparate transaminase \< 150IU/L
  * Alanine transaminase \< 150IU/L
  * Creatinine \< 3.0mg/dl
* Able and willing to give valid written informed consent

Exclusion Criteria:

* Pregnancy(woman of childbearing potential:Refusal or inability to use effective means of contraception)
* Breastfeeding
* Active or uncontrolled infection
* Concurrent treatment with steroids or immunosuppressing agent
* Prior chemotherapy,radiation therapy, or immunotherapy within 4 weeks
* Uncontrolled brain and/or intraspinal
* Decision of unsuitableness by principal investigator or physician-in-charge
Bradycardia Following Intraoperative Administration of Dexmedetomidine

This is a retrospective chart review to evaluate the postoperative course of all pediatric patients admitted to the hospital following adenotonsillectomy over the past 24 months to evaluate the incidence of bradycardia in children who received dexmedetomidine intraoperatively and identify confounding factors which may be precipitating the bradycardia or potentiating the negative chronotropic effects of dexmedetomidine.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing adenontonsillectomy or tonsillectomy during 2011 and 2012.

Exclusion Criteria:

* None.
A Study to Investigate the Influence of MK0859 on Blood Pressure (MK-0859-012)(COMPLETED)

This study will investigate the influence of MK0859 on ambulatory blood pressure, and how safe and tolerable MK0859 is on the subjects This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).


Eligibility Criteria:
Inclusion Criteria:

* You are between the ages of 45-75
* You are a man or non-pregnant woman
* You agree to not eat or drink fruit or fruit juices (orange, apple or grapefruit) for 2 weeks before starting study medication

Exclusion Criteria:

* You have smoked or used other nicotine-containing products (chewing tobacco) within the last 6 months
* You have used St. John's Wort or any products that include it within the last 2 weeks
* You have used herbal, organic, dietary or nutritional remedies within the last 2 weeks
* You have a history of drug allergies (anaphylaxis, angioedema)
* You have taken an investigational drug in another clinical trial within the last 4 weeks
* You have a history of cardiovascular disease including hypertension (high blood pressure)
* You have a history of renal disease
* You have a history of gall bladder disease or have had abnormal liver function tests
* You have a history of drug or alcohol abuse
* You drink more than 6 cups of caffeinated beverages a day (coffee, tea or cola)
Antibiotic Selection Using Next Generation Sequencing vs Urine Culture

This is a randomized controlled clinical study evaluating the use of next-generation sequencing (NGS) to improve antibiotic prescribing before ureteroscopy or percutaneous nephrolithotomy.

NGS will be performed on voided urine collected as routine care approximately 30 days prior to surgery. Results will be presented to Infectious Disease pharmacist within 48-72 hours to help select the most appropriate antibiotics, and independently as part of routine care, surgeons will choose the antibiotic that they would use in each case, while the Infectious Disease pharmacists would select their optimum choice. Approximately 220 subjects will be randomly assigned in a 1:1 ratio to receive either NGS antibiotic recommendation or standard of care (SOC) prophylaxis prescribed treatment. Subjects assigned to standard of care will have urine cultures sent for analysis, and the physician will choose antibiotics based on results as per usual practice. Subjects assigned to the NGS group, in addition to routine urine culture results, will have NGS urine culture results sent to an investigational drrug (ID) pharmacist, and recommendations will be shared with the physician to determine the antibiotic selection. The physician will ultimately decide the appropriate antibiotics to prescribe. Approximately 7-14 days after surgery, the research staff will conduct a telephone call to ask about any post-operative infections, complications, and any additional antibiotics that were prescribed.

Eligibility Criteria:
Inclusion Criteria:

* Patients planning to undergo kidney or bladder stone removal surgery using endoscopy including ureteroscopy and percutaneous nephrolithotomy or any other transurethral procedure
* Age 18 or older
* Able to give informed consent

Exclusion Criteria:

* Unwilling or unable to provide informed consent
* Age \< 18
* Does not meet inclusion criteria