cyrilzakka/clinical-trials huggingface dataset:
Erector Spinae Plane Block Versus Modified Thoracolumbar Interfascial Plane Block

the purpose of this study is to compare of better postoperative analgesia following lumber spine discectomy


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent from the patient.
* Physical status: ASA 1\& II.
* BMI = (25-30 kg/m2).
* Type of operation: elective Lumbar discectomy .

Exclusion Criteria:

* Altered mental state.
* Patients with known history of allergy to study drugs.
* Advanced hepatic, renal, cardiovascular, and respiratory diseases.
* Patients with chronic pain.
* Patients receiving anticoagulants.
* Contraindications of regional anesthesia, e.g., allergy to local anesthetics, coagulopathy, or septic focus at site of injection.
Suitability of Unobtrusive Bed Monitoring and Wrist-worn Heart Rate Monitor for Patient Monitoring

Novel technology enables it to monitor noninvasively the vital signs of a patient. Such a monitoring is immediately required to improve patient safety and to reduce hospital readmissions. In this study, novel bed- and wearable sensors are studied for this purpose.

Unobtrusive bed monitoring devices have gained popularity in the area of voluntary sleep quality monitoring for wellness purposes. Most of these devices rely on the measurement of ballistocardiographic forces caused by the acceleration of blood when the heart pumps it to aorta, forces caused by respiration movements and other movements of the person being monitored. A thin film-type force sensor placed under the bed mattress, between the matrices or under the bed sheet is often used for measuring these forces. While proven to provide adequate reliability and accuracy for wellness monitoring of healthy people, unobtrusive bed monitoring solutions have not yet been widely deployed in hospital patient monitoring even though there would be much use for such technology e.g. in regular hospital wards where currently the amount of patient monitoring is very limited.

If proven operational in this application, bed monitoring technology would provide tremendous benefits in both clinical and home monitoring scenarios. Wrist worn pulse plethysmography (PPG) devices have increased their popularity as heart rate monitors, referred as optical heart rate monitors (OHR) for sports and wellness in recent years and their ability to measure average heart rate during movement and beat-to-beat heart rate while at rest accurately with healthy people has been shown.

The objective of the study is to collect ECG and movement data measured with a wearable ECG monitor and simultaneously record data with unobtrusive bed sensor and wrist worn PPG device. Data recorded with the bed and wrist sensors and vital parameters calculated from that or provided by the monitoring devices directly will be compared with the reference.

The purpose of the study is to gain knowledge about the feasibility of unobtrusive bed and wrist monitoring devices for patient monitoring. The collected data will directly provide information on the accuracy of the current algorithms of the monitors. Besides this evaluation, the collected data will be used in developing new algorithms for detection of cardiac problems.

The study includes collection of data from vascular patients referred to surgical operation in Tampere University Hospital. Data collection takes place at vascular surgical ward where one dedicated research bed is equipped with bed monitoring devices. Another group of subjects is formed by healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Age\>50
* Indication for operation: peripheral arterial bypass and/or endarterectomy, aortic surgery, carotid surgery
* Volunteering

Exclusion Criteria:

* Pacemaker
* Denial
Pioglitazone vs. Insulin Glargine in the Treatment of Secondary Drug Failure in Type 2 Diabetes

Pioglitazone and insulin glargine are equally effective in achieving glycemic control in secondary drug failure of type 2 diabetes but the mechanisms of actions are different.

The present study was undertaken to assess differences in how insulin glargine vs. pioglitazone affect:

* Beta-cell function as measured by proinsulin/insulin, homeostasis model assessment for insulin secretion (HOMA β-cell) and glucagon stimulated C-peptide test
* Insulin sensitivity as measured by adiponectin, homeostasis model assessment for insulin resistance (HOMA-IR) and insulin tolerance test and
* Surrogate markers of cardiovascular disease as measured by BNP, NT-pro BNP and plasma lipid profile as add-on therapy in patients with T2D and secondary drug failure. The patients' satisfaction with each treatment was also surveyed.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes
* inadequately controlled on 50% of maximal-dose of an insulin secretagogue and metformin

Exclusion Criteria:

* heart failure (NYHA II-IV)
Community Based Rehabilitation Model After Total Knee Replacement

To investigate the clinical efficacy of community-based early stage knee replacement rehabilitation program as compared with usual care in acute hospital outpatient clinic

To investigate the clinical efficacy of community-based early stage knee replacement rehabilitation program as compared with usual care in acute hospital outpatient clinic

Eligibility Criteria:
Inclusion Criteria:

i) unilateral TKA; ii) age 55 years old and above; iii) able to engage in outpatient physiotherapy; iii) postoperative knee flexion ≥75° and knee extension ≤5°; iv) able to ambulate independently preoperatively.

Exclusion Criteria:

i) had revision TKA or fully constrained knee arthroplasty; ii) had knee replacement for indications other than osteoarthritis; iii) had post-operative complications during hospital stay; iv) were unable to participate due to cognitive impairment or language barriers; v) had acute spinal diseases or joint, muscle or systemic diseases affecting gait; iv) had comorbid health conditions that would prevent active participation (e.g. prior hemiplegic stroke, severe cardiorespiratory illnesses.
Evaluation of Patient Satisfaction and Therapeutic Impact Regarding Joint Consultation Rheumatologist/Dermatologist

Current increase in the number of multidisciplinary consultations, but little documentation on their impact on patient management. More specifically, in the context of psoriatic arthritis, we are seeking to investigate the interest for the patient, through his or her satisfaction and the evolution of the activity of his or her pathology, of a global, joint management in Rheumatology and Dermatology.


Eligibility Criteria:
Inclusion Criteria:

* All patients received in a joint rheumatologist/dermatologist consultation at the Le Mans Hospital

Exclusion Criteria:

* Diagnosis of psoriatic arthritis not retained
Dual PSMA and FDG PET Imaging for Patients With Advanced Prostate Cancer

This study will use Prostate Specific Membrane Antigen (PSMA) and (18)F-Fluorodeoxyglucose Positron Emission Tomography (FDG PET) imaging in patients with advanced prostate cancer to learn about tumor biology across disease stages and during treatment. This may help with treatment selection and potential response monitoring in the future.


Eligibility Criteria:
Inclusion Criteria:

* Male, age ≥ 18 years
* Histologically or cytologically confirmed prostate cancer (adenocarcinoma)
* Poor risk patients with mCSPC at study enrollment
* De novo or recurrent high volume mCSPC as per conventional imaging (CT chest abdomen pelvis, or MRI, plus bone scan) prior to starting ADT and ARPI
* High or low volume mCSPC plus PSA ≥4.0 after 6-8 months of initiating ADT
* Willing to undergo study PET scans and remain under the care of medical oncology, radiation oncology or urology physician at Princess Margaret Cancer Center.
* No prior PSMA or FDG PET imaging within the last 60 days at each specified time point on study
* Patients enrolled in clinical trials are eligible if they satisfy all other criteria of eligibility

Exclusion Criteria:

* Under a randomized-controlled trial with unknown allocation of systemic therapy
* Inability to undergo or successfully complete PSMA PET and FDG PET imaging exams
* Unable to provide written consent by patient and their legal representatives
* In the opinion of the treating physician:
* conditions which would significantly impair the patient's ability to comply with study procedures and follow up
* Significant uncontrolled comorbidity, which may negatively impact the safety or interpretability of study PET imaging

  * another active malignancy
  * patient on dialysis
  * another radioisotope or investigational systemic agent within 5 half-lives prior to PET imaging
EffeKt Taiwan- Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Taiwan

The aim of this international prospective post-marketing surveillance study is to obtain data on treatment procedures, long-term safety and efficacy and patient acceptance of KOGENATE Bayer/FS in treatment of patients with haemophilia A under daily-life treatment conditions.


Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of hemophilia A, independent of age, treated with KOGENATE FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE FS. For pretreated patients with more than 100 exposure days an inhibitor assessment within three months prior to enrollment should be available; for pretreated patients with less than 100 exposure days an inhibitor assessment at baseline should be available.
mHealth Biometrics for Young People With Obesity (MOTIVATE- LOOP)

The investigators aim to undertake a feasibility randomised controlled trial (RCT) to investigate whether mHealth technology, allowing biometric informed feedback and coaching on exercise and PA, can be incorporated into the existing Liverpool Overweight and Obesity Programme (LOOP) at Alder Hey Children's Hospital. The overall objective is to have an evidence-based exercise and PA intervention ready to evaluate in a future RCT.

The study will recruit patients from the Liverpool Overweight and Obesity Programme at Alder Hey Children's Hospital (LOOP@ Alder Hey). 40 participants will be recruited and randomly assigned to one of two groups (Control n=20, Intervention n=20). Patients in the control group will continue to follow the LOOP@ Alder Hey programme but physical activity sessions will be monitored during the 12-week intervention using a heart rate monitor. Importantly, the heart rate monitor will not provide any feedback to the patient. The intervention group will be provided with exercise counselling and to support this they will also be provide with a wristwatch that can monitor everyday activity and their heart rate, a smartphone app and access to a website. The intervention group will also participate in 5 consultations with an exercise specialist to plan their exercise programme and be updated on their progress towards physical activity targets. Weekly text message updates will also provide feedback to the intervention group with participants able to respond to these updates. Before and after the 3-month supported interventions, volunteers will participate in testing to assess changes in physical activity, blood pressure, glycaemia control, body composition and health related quality of life. Interviews with participants, parents and the LOOP Clinic multidisciplinary team will form the basis for a review of the pilot randomised control trial. Participants will also fill out 6 validated questionnaires about motivations, the impact of their condition on daily life and their typical exercise levels.

Eligibility Criteria:
Inclusion Criteria:

* Patients within the Liverpool Overweight and Obesity Programme aged 12-18 years
* BMI\>30
* Receiving input from members of LOOP clinic at Alder Hey for weight management
* For those prescribed Metformin: Stable dose for 3-months or more

Exclusion Criteria:

* Severe learning/behaviour difficulties
* Severe autism
* Secondary causes of obesity like Cushing's disease
* Syndromic causes of obesity
* Patients on GLP-1 analogues for obesity
* Type 2 diabetes mellitus
* Require an interpreter
Dysrhythmias During General Anesthesia in Children

To describe the types and incidence of cardiac dysrhythmias that occur under anesthesia in the present anesthesia environment.

It is unclear what the current state of anesthesia associated dysrhythmias is in the pediatric population. This was last investigated retrospectively in 1992 when the predominant volatile agent used for inhalation induction was halothane. Sevoflurane was approved by the Food and Drug Administration in 1995. Since that time, Sevoflurane has displaced halothane as the agent of choice for inhalation induction and has relegated halothane to be used in a narrow niche which primarily involves patients with very specific congenital heart diseases. It has been described that halothane has a larger proarrhythmic effect than sevoflurane for ventricular dysrhythmias. With the transition from the halothane to the sevoflurane era, a reassessment of the incidence and types of dysrhythmias occurring in non-cardiac pediatric patients is important.

Eligibility Criteria:
Inclusion Criteria:

Children, while under anesthesia, having

1. circumstances of tachycardia and bradycardia,
2. administration of medications used in the treatment of dysrhythmias,
3. the commentary which includes comment about the heart rhythm or therapy for dysrhythmia,
4. in the quality assurance database for evidence of dysrhythmia

Exclusion Criteria:

Children with a known pre-operative:

1. prior history of dysrhythmia and/or
2. residual congenital heart disease
3. anti/pro dysrhythmic medications
Intertrochanteric Femoral Fracture Fixation Trial

The main goal of the study is to determine which cephalomedullary nail results in a better functional outcome for the patient with an unstable intertrochanteric hip fracture. Subjects will be randomized to fixation with either a Gamma3 cephalomedullary nail or an InterTan cephalomedullary nail. Outcomes will be reviewed over a 12 month follow-up period.

Primary Hypotheses:

Patients who maintain their initial fracture reduction and subsequent position over time with minimal femoral neck shortening and varus will demonstrate significantly improved functional abilities, including gait and abductor function.

Secondary Objective:

* Whether radiographic differences in femoral neck shortening and varus collapse translate into a worse functional outcome to the patient.
* Whether there are differences in mortality between treatments
* Whether there is a time frame follow up after which there is no difference in outcomes.
* Evaluate the device used for fracture stabilization as a potentially contributing factor for maintenance of normal or near-normal abductor function and gait.

Primary Outcome:

The primary outcome will be functional abilities at 3, 6 and 12 months after injury. The following measures of functional ability will be utilized:

Methods:

This is a prospective, randomized non-blinded study. Patients will be identified as they present to the orthopaedic trauma service of Tampa General Hospital with a qualifying injury to determine their interest in participating in the study. Written informed consent will be obtained prior to initiation of any study procedures.

Group A will undergo cephalomedullary nail-based single screw intertrochanteric hip fracture fixation device (Gamma 3 nail). Group B will receive the integrated dual screw intertrochanteric hip fracture fixation device (Intertan nail). Patient outcomes will be analyzed using intention to treat principles. Following randomization assignment, surgeons will all follow the identical described surgical technique, with the only variable being the implant used. Post-operative immobilization and time to weight bearing and rehabilitation protocols will be again identical for all patients regardless of fixation technique.

Eligibility Criteria:
Inclusion Criteria:

* Patients surgically treated for an intertrochanteric femur fracture at Tampa General Hospital.

  * Skeletally mature patients over the age of 60; both genders.
  * Community ambulators.

Exclusion Criteria:

* Patients with ipsilateral lower extremity injury
* Patients under age 60
* Co-existent, severe knee or back problems
* Muscle contracture around the knee or hip joint
* Individuals who have had TKA within 6 months
* Body mass index (BMI; kg/m2) \>40
* Suspicious of pathologic fracture (tumor in origin)
* Pre-op mobility: Non ambulatory; ambulatory indoors with living support
* Cognitive impairment or dementia
* Prisoners or impending incarceration
* Homeless or no stable address.
Pericapsular Nerve Block Versus Interscalene Nerve Block for Acute Pain Management in Shoulder Arthroscopy

The aim of this study is to compare PENG and ISB after shoulder arthroscopy for postoperative pain management after shoulder arthroscopy.

Shoulder arthroscopy is a common procedure done is orthopedics for many surgical indications as rotator cuff tears, stiffness and instability. This procedure has a well - documented postoperative pain. To improve the outcome after surgery, effective pain control is needed.

Various methods are used for postoperative pain management. Intravenous opioid agents are among them, but they may cause undesirable side effects, such as respiratory depression, sedation, constipation, allergic reaction, nausea, and vomiting. Thus, alternative techniques are preferred.

Interscalene brachial plexus blocks (ISBPBs) are often used to provide perioperative analgesia and anesthesia for shoulder surgery. They target nerve roots C4-C6 and thereby provide regional analgesia to the shoulder and upper arm. Although ISBPBs are often performed in combination with general anesthesia (GA) to enhance postoperative analgesia, they are also sometimes used as a sole means of anesthesia.

The pericapsular nerve group (PENG) block is an ultrasound-guided approach, first described by Giron-Arango et al. for the blockade of the articular branches of the femoral, obturator and accessory obturator nerves that provide sensory innervation to the anterior hip capsule. It has been successfully used as an alternative regional anaesthesia technique for the management of acute pain after hip fracture, and for analgesia after elective hip surgery

Eligibility Criteria:
Inclusion Criteria:

* Body mass index \< 40 kg/m2
* American Society of Anesthesiologists (ASA) physical status I-II
* posted for elective shoulder arthroscopy

Exclusion Criteria:

* Known allergy to local anesthetics
* allergy to all opioid medications
* diagnostic shoulder arthroscopic procedures
* patients with chronic opioids use and coagulopathy
Self-applied Acupressure for Arthralgia-fatigue-sleep Disturbance in Breast Cancer

This study aims to evaluate the feasibility, acceptability and preliminary effects of self-applied acupressure on arthralgia-fatigue-sleep disturbance symptom cluster in breast cancer survivors receiving aromatase inhibitors. This is a preliminary randomized controlled trial, with a three-arm trial design including verum self-acupressure, sham self-acupressure, and usual care. Subjects will include 52 breast cancer survivors who are receiving aromatase inhibitors and have experienced a moderate level of joint pain and at least one of the two symptoms including fatigue and sleep disturbance. Subjects who are randomized to either the verum self-acupressure group (group A) or the sham self-acupressure group (group B) will receive up to 8 weeks of the intervention consisting of two components: (1) two individual/group acupressure training sessions over 2 weeks and (2) self-acupressure for 6 weeks. The method and duration of self-acupressure in the sham group will be the same to those in the verum intervention group. The control group will receive usual care. The outcome measures of this study will be related to feasibility, acceptability and preliminary effects of self-acupressure. Individual in-depth interviews will be conducted with selected participants in group A and B to understand their perceptions and perceived effectiveness of the intervention.


Eligibility Criteria:
Inclusion Criteria

* Female adult aged 18 and older;
* Clinical diagnosis of early-stage (Stage I, II, or IIIa), hormone-receptor-positive breast cancer;
* Completion of surgery, and/or chemotherapy and/or radiotherapy;
* Currently taking the third generation of AIs (anastrozole, letrozole, or exemestane) for at least 1 month;
* Based on their self-reports of moderate symptoms of joint pain and fatigue or sleep disturbance;
* Willing to comply with the intervention protocol, and
* Being able to communicate in Chinese .

Exclusion Criteria:

* Previous receipt of acupuncture and acupressure within the past six months;
* Currently receiving medications (unchanged for 3 month), physical therapy and other complementary and alternative medicines for the treatment of joint pain, fatigue and sleep disturbance;
* Prior joint surgery or fracture during the past six months;
* Mentally incapable of participating in the study (Hong Kong version of Montreal Cognitive Assessment score\<22);and
* Inability to perform self-care (Karnofsky Performance Scale score\<70).
Implementing Surgery School Prehabilitation Using Telehealth

The physiological challenge of major surgery has been likened to running a marathon. In both cases, preparation is critical. Yet, many patients undergo major surgery without understanding the potential consequences.

The STTARRS trial aims to test the effect of an education program delivered via telehealth in people preparing for lung or major abdominal cancer surgery , compared with usual care on the development of a respiratory complications after surgery.

The secondary aims will be to determine the effect of the online education program for people preparing for lung or major abdominal cancer surgery compared to usual care on the following outcomes; acute hospital length of stay, surgical recovery, physical function and activity, self-efficacy, behaviour change, symptoms, health-related quality of life, number of days alive and out of hospital and health service usage and survival.

This trial includes one sub-study. The sub-study will recruit eligible people preparing for lung cancer surgery. In the sub-study, 65 participants will receive an individualised inspiratory muscle training and walking program delivered and monitored by telehealth in addition to the main STTARRS trial intervention before surgery.


Eligibility Criteria:
Inclusion Criteria:

* Preparing for lung cancer (open or video assisted) or major abdominal cancer surgery (upper GI, hepatobiliary and colorectal, open or video assisted).
* Provide consent
* Have primary treating surgeon approval
* Proficient in English to understand testing, video interventions as well as outcome assessments.

Exclusion Criteria:

* Concurrent, actively treated other malignancy of history of other malignancy treated within the past year,
* Severe or unstable psychiatric, cognitive or substance abuse disorders, such that precludes informed consent or interferes with cooperation with trial requirements or current inpatients.