cyrilzakka/clinical-trials huggingface dataset:
Postoperative Patient Controlled Epidural Analgesia After Total Knee Arthroplasty With 2ug/ml Fentanyl Combine With 0.2% Ropivacaine or 0.2% Levobupivcaine

Postoperative epidural analgesia (EA) is an effective and well-accepted modality of pain relief technique after having total knee replacement operation(1,4). Patient controlled epidural analgesia (PCEA) has been shown to be safe and effective in standard ward setting(2) and results in reduced epidural analgesic requirements(3). Besides, it also bear the advantage of avoidance of overdose, reduction of waiting times and involvement of patients in their analgesic regimen(3). Both ropivacaine and levobupivacaine are the local anaesthetic using in epidural analgesia which has been proven to be safe and effective(4). 0.2% Ropivacaine with 2ug/ml fentanyl has been used in our locality for more than 8 years. Another local anaesthetics, levobupivacaine, a S-enantiomer of bupivacaine has come up in Hong Kong, which has been proved to be safe, effective and may be better value for money. These two drugs has been proven to have similar analgesic potency in using as EA for postoperative pain relief for other operation(5,6,7) and for orthropaedics operation but in different concentration(4). Concerns have been raised about the introduction of the levobupivacaine in the departmental protocol. Objectives of this study are A)to determine the equivalence of two local anaesthetics regimen ; 0.2% ropivacaine with 2ug/ml fentanyl and 0.2% levobupivacaine with 2ug/ml fentanyl and B) to assess the cost-effectiveness of using these two regimens.

The null hypothesis is that the difference of analgesic effect, presented with visual analogue score, of two patient controlled epidural analgesia regimen, the 0.2% ropivacaine with 2 ug/ml fentanyl and 0.2% levobupivacaine with 2ug/ml fentanyl is higher than the threshold of 9 mm VAS. (8,9,10)


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old, ASA I -III and
* Undergoing total knee arthroplasty
* Combine spinal-epidural anaesthesia

Exclusion Criteria:

* Known hypersensitivity to amide-type local anaesthetics
* Known hypersensitivity to opioids
* Known history of severe cardiovascular, renal, hepatic, neurological or psychiatric disease as judged by the investigator
* Known history of peripheral neuropathies
* Those receiving chronic analgesic therapy, or any contraindication for epidural analgesia (e.g. clotting disorders, or history of lumbar surgery)
* Inability to perform a pain score, or pregnancy or lactation
Fasted Exercise in People With Type 1 Diabetes

This study aims to compare the effect of a bout of high-intensity interval training (HIT) with a bout of moderate-intensity continuous training (MICT) on glucose concentrations over the subsequent 24h period.

This study aims to compare the effect of a bout of high-intensity interval training (HIT) with a bout of moderate-intensity continuous training (MICT) on glucose concentrations over the subsequent 24h period. Fourteen people with type 1 diabetes (duration of type 1 diabetes 8.2±1.4 years), all on basal-bolus regimen, completed a randomised, counterbalanced, crossover study. Continuous glucose monitoring was used to assess glycaemic control following a single bout of HIT (6 x 1min intervals) and 30 mins of moderate-intensity continuous training (MICT) on separate days, compared to a non-exercise control day (CON). Exercise was undertaken following an overnight fast with omission of short-acting insulin. Capillary blood glucose samples were recorded pre and post-exercise to assess the acute changes in glycaemia during HIT and MICT.

Eligibility Criteria:
Inclusion Criteria:

* duration of type 1 diabetes \>6 months
* basal bolus regimen
* no significant history of hyper- or hypoglycaemia (determined from medical history

Exclusion Criteria:

* duration of type 1 diabetes \<6 months,
* insulin pump therapy
* significant history of hyper- or hypoglycaemia (determined from medical history)
* obesity (BMI \>30 kg∙m-2)
* pregnancy or planning pregnancy, uncontrolled hypertension (\>180/100 mmHg)
* angina
* autonomic neuropathy
* taking any medication that affects heart rate
* major surgery planned within 6 weeks of the study
* severe nonproliferative and
* unstable proliferative retinopathy
Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Multi-Site Phase 2b Clinical Study

A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Multi- Site Phase 2b Clinical Study to Assess the Efficacy, Safety and Tolerability of 8-Week Regimens of NVXT topical product in Patients with Mild to Moderate Onychomycosis

Evaluate safety and tolerability of the two regimens of NVXT (Treatment Groups A and B) in patients with mild to moderate distal subungual onychomycosis of the target toenail.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of onychomycosis of the target toenail (defined as one of the infected great toenails).

Exclusion Criteria:

* Females who are pregnant, lactating or likely to become pregnant during the study.
Effects of Wellnara on Climacteric Symptoms

Aim of this NIS is to obtain further information on efficacy, tolerability, and acceptance of Wellnara in a large user population under the conditions of routine medical practice. Furthermore, any adverse drug reactions will be recorded in a large user population under the conditions of medical routine. To investigate the efficacy of Wellnara, patients will fill in a questionnaire, the so-called Menopause Rating Scale (MRS II). Further, the effects of treatment on skin and hair will be evaluated by the investigator. Patients will assess treatment effects on their sexual life. Safety parameters include monitoring of vaginal bleeding, measurement of blood pressure and body weight, and - as far as routinely used in the practice - calculation of waist-hip-ratio. Any relevant additional information related to adverse drug reactions will also be documented.


Eligibility Criteria:
Inclusion Criteria:

* Women who have received a prescription of Wellnara on the basis of the decision of the treating gynecologist

Exclusion Criteria:

* Limited to the criteria listed in the expert information as contraindications
Pragmatic Implementation of Mindful Awareness in Body Oriented Therapy

This is a one group study using a hybrid implementation design.

The proposed pilot study will collect preliminary data to support a larger hybrid effectiveness-implementation study designed to examine the implementation of the evidence-based Mindful Awareness in Body-oriented Therapy (MABT), delivered by massage therapists, on patient and implementation science outcomes in an interdisciplinary chronic pain clinic. The combined foci of this mixed-methods pilot study is expected to provide an indication of implementation success, highlight implementation processes, and show treatment effectiveness on health outcomes.1 MABT is a mind-body therapy designed to teach interoceptive awareness skills for symptom management and emotion regulation. The proposed pilot study uses mixed methods and a single-group repeated measures design to explore MABT implementation and to estimate the effect of MABT to reduce symptomatic distress in the treatment of chronic pain at the Osher Center for Integrative Medicine at Vanderbilt Clinic (OCIM).

Eligibility Criteria:
Inclusion Criteria:

* Patient attending clinic and who received a referral to MABT

Exclusion Criteria:

* Under 18
Comparison Of NeuroNaute Smart System to a Standard EleCTroencephalogram System in Hospital

The proposed study is designed to evaluate the performance of the Neuronaute in comparison with the gold standard EEG in patients with a regular appointment at the hospital. The design of this study is guided by two overriding factors : (i) epileptics disorders suspected or either (ii) epileptics already diagnosed.

Volunteers will be asked to participate to this study. This study will enroll 35 outpatient subjects aged 18 to 85. Informed consent will be obtained from the patients, and assent from the subjects, prior to any form of assessment or intervention as part of the study.

Patients will be submitted to the studied device record Neuronaute following by the gold standard EEG.

A grid with all EEG activity recorded during the trial will be provided for evaluation after completion of the trial.


Eligibility Criteria:
Inclusion Criteria:

* Patients, with a regular appointment to perform an EEG recording: (i) suspected of epileptic disorders or (ii) epilepsy already diagnosed.
* Age (\> 18 years),
* Affiliated to the social security
* Informed consent.

Exclusion Criteria:

* No informed consent
* Age (\< 18 years)
* No affiliation to the social security
* Unsuitable anthropometric parameters
* Pregnant women
* Recent brain surgery
* Wound or scores on the body and the scalp
* Ongoing participation in another clinical trial
* Allergy to any component from MD including : Silver, polyamide, silicone
* Sensory disorders making the patient insensitive to pain on the skin
* Behavioral disorders making the patient excessively agitated or aggressive;
* Motor or mental disorders preventing the patient from expressing his or her pain;
* Cardiorespiratory disorders likely to be aggravated by slight compression of the chest;
* The susceptibility to tension headaches (the compression exerted by the bonnet may in certain cases trigger a headache)
Reducing Cell Phone Use While Driving Among High Risk UBI Auto Policy Holders

Insurance User Based Insurance (UBI) users will be invited to participate in a randomized control trial where they will be randomized into 1 of 4 arms: (Arm 1) standard UBI, (Arm 2) Standard UBI + Free phone mounts (Arm 3) Commitment + Habit Tips, (Arm 4) Gamification + Social Competition,(Arm 5) Contest Financial Incentives. Each successive arm will experience all of the elements that the lower-numbered arms will.

Insurance company will invite User Based Insurance app users with more than 2 minutes per hours of handheld phone use in their first month of the insurance program to participate in a study to help them reduce their phone use while driving. Email invitations will include max insurance discount amount for the safest drivers in the customer's demographic group receive for not using their phone while in the User based insurance app. Participants that enroll into the study will be randomized to 1 of 4 arms: (Arm 1) standard UBI where they will continue to be monitored and receive educational material about distracted driving in the enrollment period; (Arm 2) Free phone mounts Arm, this arm will be monitored through standard UBI and receive educational material about distracted driving in the enrollment period, and free phone mounts (Arm 3)+ Commitment + Habit tips, this arm will receive educational material about distracted driving during the enrollment period, be sent a free phone mount with installation instructions, sign a personalized commitment contract to reduce their phone use, set personal phone use reduction goals, and be sent personalized habit tips framed to help them reduce their handheld phone use while driving; (Arm 4) will receive all treatments assigned to arm 2, plus social gamification feedback, where each week participants are told if they've reach their weekly handheld phone use while driving reduction goal, and receive or lose points based on whether or not they met their goal. Based on their points participants can either move up or down a level. Each week the participants will also be sent a leader board of their ranking within their group. (Arm 5) will receive all of the treatments of arm 3 plus be entered into a financial incentive contest where they can either finish in the highest level and split the prize money amongst all participants that reached that level, or the safest driver (driver ranked #1 on the leader board of their group) will receive a small weekly financial prize.

Eligibility Criteria:
Inclusion Criteria:

* Progressive Snapshot Users with policy activated within recruitment period AND reducing in a state which phone use while driving is factored into insurance rating at the time of enrollment
* Has email address

Exclusion Criteria:

* Progressive Snapshot Mobile App not updated to enable push notifications
* Baseline phone use must be greater than or equal to 2 min/hour
* Customer's Snapshot Mobile App does not collect trop data with all sensors active
* Customer in Snapshot program for \<30 days or more \>70 days
Pupillometer as a Pain Index During General Anesthesia

This study evaluates the validity of pupil diameter as an indicator of pain during surgery under general anesthesia.

Pupil diameter is known to be strongly correlated with sympathetic tone. During surgery under general anesthesia, there is no standardized means of pain assessment. As pain activates sympathetic nervous system, we hypothesized that pupil diameter can be a marker for pain during surgery.

Eligibility Criteria:
Inclusion Criteria:

* Children undergoing surgery under general anesthesia with total time of less than two hours

Exclusion Criteria:

* Children whose parent or legal guardian declined to enroll
* Any use of opioids during surgery
* History of hypersensitivity to any anesthetic agents
* Any medication that can affect sympathetic nervous activity
* Presence of underlying ophthalmologic disease
Comparison of Low-Dose, Standard-Dose Ticagrelor and Clopidogrel for Inhibition of Platelet Reactivity in Patients With Acute Coronary Syndromes

The purpose of this study is to compare Low-Dose, Standard-Dose Ticagrelor and Clopidogrel for Inhibition of Platelet Reactivity in Patients with Acute Coronary Syndromes


Eligibility Criteria:
Inclusion Criteria:

* ST elevation or non ST elevation acute coronary syndrome patients of chest pain within 24 hours

Exclusion Criteria:

* Known hypersensitivity to clopidogrel and ticagrelor and aspirin
* Treatment with anticoagulants
* Exposure to a thrombolytic agent within 24 hours prior to randomization
* Use of glycoprotein IIb - IIIa inhibitors at randomization
* History of major hemorrhage (intracranial, gastrointestinal, etc.)
* clotting disorder and/or bleeding disorder
* Any history of Severe renal or hepatic dysfunction
* Hematologic disorder including a Hemoglobin less than 10 g/L or a platelet count less than 80,000 cells/mm3
* Cardiac shock, severe left ventricular dysfunction LVEF less than 30%
* Sick sinus syndrome or second degree of av block without permanent pacemaker
* No concurrent cytochrome p450 3a inhibitors and enhancers within 2 weeks
* Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg,drug and alcohol abuse, mental illness) or that could prevent, limit, or confound the protocol-specified assessments.
* Life expectancy of less than 6 months
* Pregnancy or lactating
* Participation in any drug study in the previous 3 months
* Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk
AR101 Real-World Open-Label Extension Study

This study is enrolling participants by invitation only. This is an open-label, safety extension study for subjects who participated in the ARC007 study.

This is a Phase 3, multi-center, North American, open-label, long-term, safety extension study for eligible subjects who received AR101 therapy in the ARC007 trial (NCT03126227) and completed the study.

Eligibility Criteria:
Key Inclusion Criteria:

* Received AR101 in study ARC007
* Completed the ARC007 study
* Use of effective birth control by sexually active female subjects of childbearing potential

Key Exclusion Criteria:

* Developed a clinically significant change in health status during the ARC007 study which in the opinion of the investigator would make the subject unsuitable for participation in this study.
* Receiving a prohibited medication or anticipated use of a prohibited medication \[e.g., angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers or calcium channel blockers\], any monoclonal antibody, any investigational peanut immunotherapy, or any other immunomodulatory therapy.
* Currently in the build-up phase of immunotherapy for any nonfood allergen.
* Currently participating in any other interventional clinical study outside of the ARC007 study that was just completed.
Systemic Oxidative Stress Score as a Predictor of Gastric Cancer Survival and Recurrence Risk

The Systemic Oxidative Stress Score (SOSS) , a comprehensive score reflecting the oxidative stress conditions in the microenvironment, can independently and effectively predict tumor burden and long-term prognosis in GC patients. Nomograms based on SOSS provide a potential and promising model for risk stratification and guiding the implementation of treatment decisions.

We retrospectively analyzed the clinical data of gastric cancer patients who underwent radical gastrectomy in three hospitals from January 2009 to June 2020. The data from one hospital were randomly divided into a training cohort and an internal validation cohort in a 7:3 ratio, while the data from the other two centers were used as an external validation cohort. In the training cohort, COX proportional risk models were employed to identify key indicators of SOSS and independent prognostic factors influencing patients' OS and DFS. Subsequently, based on the results of the multifactor COX analysis, two predictive models for OS and DFS were developed. The predictive efficacy, calibration, and clinical utility of the models were evaluated using ROC curves, calibration curves, and decision curves in the internal and external validation cohorts, respectively. Both models demonstrated good discriminative ability between postoperative survival and recurrence risk, outperforming TNM staging in terms of predictive accuracy.

Eligibility Criteria:
Inclusion Criteria:

1) gastroscopic histopathological diagnosis of gastric adenocarcinoma; 2) radical gastrectomy for GC; 3) preoperative examination of oxidative indicators including Fbg, CHOL, ALB, TBIL, DBIL, and CR within seven days before surgery; and 4) the tumor did not invade neighboring organs or had no distant metastasis.

Exclusion Criteria:

1) gastroscopic histopathological diagnosis of non-adenocarcinoma, 2) gastric stump cancer, 3) neoadjuvant chemotherapy, 4) other malignant diseases besides GC, 5) incomplete medical records, and 6) patients with GC lost to follow-up.
Death Rate in Anesthesia: A Study in a Tertiary Hospital

Death rate in anesthesia is one of the most valuable methods to assess the safety of anesthesia practice among different types of patients.

In the investigators study, the investigator will review the death rate in anesthesia whether regional or general over the past five years from 2010 to 2014, by examining the patients records from the hospital database.

Death rate in anesthesia is one of the most valuable methods to assess the safety of anesthesia practice among different types of patients. Most of the studies of death rate in anesthesia are retrospective. Although retrospective studies suffer many draw backs in their design and results, but they are still common method to evaluate the safety of anesthesia practice for surgical patients.

In the investigators study, the investigators will review the death rate in anesthesia whether regional or general over the past five years from 2010 to 2014, by examining the patients records from the hospital database.

The cause of death will be grouped into: totally anesthesia related, partially anesthesia related, surgery related or patient condition related.

The records and files of dead patients will be examined by committee from the researchers to estimate the cause of death.

The end point of the investigators study will be anesthesia death rate inside the hospital.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent anesthesia and surgery.
* Patients who died inside the hospital.

Exclusion Criteria:

* Patient who underwent anesthesia and surgery and do not died and discharged home.
* Patients who died outside the hospital.
Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF): A Type 1 Hybrid Effectiveness- Implementation Trial

This study is trying to improve the hospital-to-home transition for people with heart failure who receive home care services. The study will test an intervention called I-TRANSFER-HF, which differs from usual care by combining early home health nurse visits and outpatient medical appointments.

The study is interested in two questions:

1. Is I-TRANSFER-HF better than usual care at preventing heart failure patients from returning to the hospital within 30 days?
2. Are there parts of I-TRANSFER-HF that are easy or hard to implement in the real world?

The researchers will answer these questions by testing the intervention among pairs of hospitals and home health agencies across the country. During the study, the hospital-agency pairs will be asked to implement I-TRANSFER-HF. The researchers will then compare the results from before and after I-TRANSFER-HF was adopted. They will also interview people from these hospitals and agencies to see how I-TRANSFER-HF is being implemented under real-world conditions.


Eligibility Criteria:
Aim 1, Inclusion Criteria:

* Adults hospitalized for HF who transition from participating hospitals to their partner HHC agency during the study period.

Aim 1, Exclusion Criteria:

* Patients hospitalized for HF and discharged: home without HHC, or to an inpatient rehabilitation facility, skilled nursing facility, or hospice; patients with end stage renal disease on dialysis and those with left ventricular devices.

Aim 2, Inclusion Criteria:

- Healthcare professional involved in the transition of heart failure patients from the acute care setting (hospital) to HHC (home health care) agencies, and the implementation of the I-TRANSFER-HF at one of the four participating hospital-HHC dyads.

Aim 2, Exclusion Criteria:

- Healthcare professional not involved in the transition of heart failure patients from the acute care setting (hospital) to HHC (home health care) agencies, and the implementation of the I-TRANSFER-HF at one of the four participating hospital-HHC dyads.
Hannover Dialysis Outcome Study

Mortality rates of patients with acute kidney injury in the intensive care unit have changed little over the past few decades despite significant advances in supportive care. Few interventions have been shown to result in an improvement of in-hospital mortality of these patients, with dose of renal replacement therapy (RRT) being one of the most important. Patients undergoing continuous veno-venous hemofiltration had better outcomes with ultrafiltration rates of 35 mL/kg/h or 45 mL/kg/h than those treated at a rate of 20 mL/kg/h. In a different trial, intermittent hemodialysis on a daily basis resulted in better control of uremia, fewer hypotensive episodes during dialysis, and more rapid resolution of acute renal failure than thrice weekly hemodialysis. In the present study we examine survival and renal recovery in critically ill patients with acute kidney injury that are treated with a currently recommended (standard) dose of RRT, and patients that receive intensified RRT.


Eligibility Criteria:
Inclusion Criteria:

* non post-renal AKI with RRT dependency indicated by oliguria/anuria \<30mL/h \>6 hours prior to inclusion
* loss of kidney function of \>30% within 48 hours prior to inclusion
* hyperkalemia \>6.5 mmol/L
* severe acidosis with pH\<7.15

Exclusion Criteria:

* pre-existing chronic kidney disease (CKD) as defined by an estimated glomerular filtration rate \<50mL/min or a plasma creatinine concentration \>1.7 mg/dL (\>150 µmol/L) more than 10 days prior to initiation of the first RRT
* presence of AV-fistula or dialysis catheter
* participation in another study
* consent denial or withdrawal
* need for extra corporal membrane oxygenation therapy.