cyrilzakka/clinical-trials huggingface dataset:
Remote Ischemic Preconditioning in Patients Undergoing Acute Minor Abdominal Surgery

This study examines if remote ischemic preconditioning in patients undergoing minor acute abdominal surgery (laparoscopic cholecystitis due to acute cholecystitis) is associated with a modulation of endothelial dysfunction. half of the patients will receive remote ischemic preconditioning prior to surgery, the other half will serve as controls.

Remote ischemic preconditioning (RIPC) consists of cycles of forearm or leg ischemia and reperfusion by the inflation of a blood-pressure cuff over the systemic blood pressure for brief periods. The procedure is simple, safe and with no clear side effects. In clinical studies covering acute cardiology RIPC has effectively reduced myocardial injury, postoperative cardiovascular complications and cardiac mortality. Recently, the effect of RIPC on attenuating ischemia-reperfusion injury has been investigated in non-cardiac surgery as well. The organ specific ischemia-reperfusion injury, systemic oxidative stress and inflammatory response were attenuated due to the intervention but a complete understanding of the underlying protective mechanisms of RIPC is however still lacking.

Experimental and clinical studies have implicated that the stimulus of RIPC is transmitted from the preconditioned tissue to other tissues and organs by humoral, neural and systemic anti-inflammatory mediators. The humoral and neural pathway are thought to be dependent on endogen substances such as adenosine, bradykinin, nitrogen oxide (NO) and calcitonin-gene-related-peptide (CGRP).

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing acute or subacute cholecystectomy due to acute cholecystitis with a maximum of 7 days of symptoms prior to surgery

Exclusion Criteria:

* Not capable of giving informed consent after oral and written information
* Surgery within 30 days of study inclusion
* Conditions that prevent the performance of remote ischemic preconditioning on the upper extremity, e.g. fractures, paresis, lymphedema
* performance of concomitant endoscopic retrograde cholangiopancreatography (ERCP) during surgery
* synchronous pancreatitis
* synchronous cholangitis
The Clinical Effectiveness of Static Resting Splints in Early Rheumatoid Arthritis

This study tested the hypothesis that there would be a difference in the 12 month progression of structural hand impairment and hand function between a group of patients with early RA who received static resting splints and those that did not.

This study is a multi centred RCT recruiting patients across 8 rheumatology occupational therapy departments in the UK. Patients with early RA (\<5 years) were recruited. The study followed patients over a 12 month treatment period. Patients were randomised to receive standardised occupational therapy or standardised occupational therapy plus static resting splints over 12 months. The primary outcome measure was dominant hand grip strength and secondary out measures included; dominant hand MCPJ ulnar deviation, the button board from the Arthritis Hand Function Test and the Michigan Hand Outcomes Questionnaire.

Data were analysed using ANCOVA. Baseline outcome values, Ritchie Scores at baseline and the number of intra articular wrist and hand steroid injections were controlled for as covariates.

This study is a multi centred RCT recruiting patients across 8 rheuamtology occupational therapy departments in the UK. Patients with early RA (\<5 years) were recruited. The study followed patients over a 12 month treamtent period. Patients were randomised to receive standardised occupational therapy or standardised occupational therapy plus static resting splints over 12 months. The primary outcome measure was dominant hand grip strength and secondary out measures included; dominant hand MCPJ ulnar deviation, the button board from the Arthritis Hand Function Test and the Michigan Hand Outcomes Questionnaire.

Data were analysed using ANCOVA. Baseline outcome values, Ritchie Scores at baseline and the number of intra articular wirst and hand steroid injections were controlled for as covariates.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of RA, less than 5 years duration

Exclusion Criteria:

* Patients with previous wrist and hand surgery, non-addressable fixed hand or wrist deformity, those from vulnerable group
Effect of Long-term Transcranial Direct Current Stimulation (tDCS) on Appetite Control Related Brain Regions

The purpose of this study is to investigate the long-term effect of Transcranial Direct Current Stimulation (tDCS) on appetite control related brain regions.

Transcranial direct current stimulation (tDCS) is emerging tool for brain modulation in a variety of clinical conditions. In addition, recent neuroimaging studies suggest that modifying the activity of brain circuits involved in eating behavior could provide therapeutic benefits in obesity.

The investigators aim to assess whether long-term modulation of the dorsolateral prefrontal cortex (DLFPC) using tDCS, modifies behavioral response and brain activity while watching visually presented food cues and taste cues in obese subjects.

Subjects will be randomly divided into sham and real tDCS arms. Subjects will receive sham or real tDCS ten times. Subjects will be investigated before and after sham or real tDCS interventions. Subjects will perform functional MRI experiments with visual and taste food cues. Questionnaire with behavior measures, body compositions, blood tests will be performed.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 26 kg/m2

Exclusion Criteria:

* History of brain trauma, epilepsy, or other neurological problems
The Training Effects of Tinkering Activities on Cognitive Flexibility in Older Adults From Communities

Aging has been a serious global-wise concern in public health. In particular, elders face declination of cognitive functions that threaten their quality of life. A good approach to slow down cognitive declination during aging processes is therefore in urgent need. According to the Successful Aging model (Rowe, J.W. and Kahn, R.L) participation in meaningful occupational activity may maintains high cognitive and body function. This sub-project is a part of the larger integrated project that will address the need for cognitive promotion by conducting cognitive training interventions on community older adults, utilizing the National Taiwan Science Education Center (NTSEC) as the public recruiting site as well as intervention site. In this sub-project, a 12-week intervention will be carried out with three protocols: 1) Tinkering activities, 2)Controlled Tinkering Activities, and 3) Board Game intervention. Board games serve as a commonly seen cognitive training, with a growing series of literature continuing to support board games being the medium of cognitive promotion. Tinkering activities are primarily used in fields of education that comprise science, art, and technology. Through a series of themes objectives, participants can involve interestingly, creatively, and flexibly in the activity when the participants fulfill the goal with the materials retrievable at the site. The anticipation is that the elders participating in Tinkering activities may increase their cognitive flexibility as the participants involve in the elements hidden within the core of the training, such as problem exploration, active thinking and inference, trial and error, and problem-solving. The investigators target to obtain pre-and post-intervention behavioral and neurophysiological data, including electroencephalogram data in 40 experimental participants, 40 active control participants, and 40 passive control participants over a period of 3 years.


Eligibility Criteria:
Inclusion Criteria:

* Literate in Mandarin and Taiwanese
* Willing to participate entirely in this research.
* Age \>65

Exclusion Criteria:

* Participated in cognitive-related training in the past two months.
* Severe impairment of visual or auditory abilities.
* Diagnosed with mild cognitive impairment (MCI), or Dementia
* Severe psychological or behavioral disorder that would seriously interfere with the progress of activity
* History of degenerative cognitive disorder (e.g., acute stroke, traumatic brain injury, unconscious), organic mental disorders, brain dysfunction, or other neurology-related diagnoses.
Ultrasound Guided Intra Articular Injection of Platelet Rich Fibrin Versus Hyaluronic Acid As Means of Pain Relief in Patients with Moderate Degree Knee Osteoarthritis

Randomised controlled trial


Eligibility Criteria:
Inclusion Criteria:

* ASA I, II.
* Moderate knee osteoarthritis

Exclusion Criteria:

* Neurological patients.
* Patients with uncontrolled co morbidities
Comparative Study of Augmented Reality vs Traditional Learning in Anatomy Education

The goal of this clinical trial is to assess the efficacy of augmented reality (AR) in anatomy teaching.

The main question to answer is: Is 3-Dimensional AR technology more effective than traditional learning methods in anatomy education? In this clinical trial undergraduate medical students with no prior anatomy education will be recruited. Participants in the AR group will learn the anatomy of the cranial nerves with an AR application using Microsoft HoloLens 2, whereas participants in the control group will learn with traditional learning methods (textbooks, atlases, videos, and online learning programs).

Anatomy is a central part in medical training and is traditionally taught through lectures, textbooks, videos and cadaver dissections. Cadaver dissections are important to understand spatial relationships and individual variations of anatomical structures. In many universities, however, financial and ethical considerations, as well as uncommon circumstances such as the COVID-19 pandemic, have restricted access to cadaver dissections. Consequently, new teaching methods based on visual technologies such as augmented reality (AR) are being implemented worldwide. AR can generate realistic 3-dimensional (3D) images overlaid in the real-word environment, merging real and virtual world to provide an interactive learning experience. The use of such technologies in education is still in the early stages, and further research is needed to assess their beneficial impact in knowledge acquisition. The TEACHANATOMY project aim to develop a 3D, interactive AR teaching module focused on the anatomy of the cranial nerves. To assess its potential value in anatomy education, the investigators will perform a study to compare traditional learning methods based on textbooks, videos, and online resources, with the novel AR learning module using the HoloLens 2 (Microsoft Corporation). The goal is to assess whether AR technology can improve anatomical knowledge and enhance student's motivation and engagement.

Eligibility Criteria:
Inclusion Criteria:

* Medical students attending the 1st or 2nd year of undergraduate medical education
* Must not have prior neuroanatomical education

Exclusion Criteria:

* Epilepsy
* Binocular vision disorder such as strabismus
* Current head and/or neck injuries
* Inflammation of the scalp and/or eye
* Amputations or partial amputations of the hands
Early DVC Ligation and Urinary Continence Recovery After RARP

The aim of the study is to evaluate the impact of early deep venous complex ligation (eDVCL) in patients affected by clinically localized prostate cancer (PCa) undergoing robot-assisted radical prostatectomy with or without pelvic lymph node dissection. Overall, 312 patients will be randomized to the standard technique vs. eDVCL. The primary endpoint is represented by early urinary continence recovery. The secondary endpoints are perioperative outcomes, erectile function recovery and positive surgical margins.


Eligibility Criteria:
Inclusion Criteria:

1. Male patients, aged between 18 and 80 years old
2. Planned to receive robot-assisted radical prostatectomy for prostate cancer
3. Able to understand and willing to sign a written informed consent document
4. On stable dose of current regular medication for at least 4 weeks prior to trial entry

Exclusion Criteria:

The participant may not enter the trial if ANY of the following apply:

1. Life expectancy of less than 12 months
2. Previous chemotherapy
3. Previous brachytherapy or external beam radiotherapy
4. Preexisting urinary incontinence defined as 1 or more pads per day
5. Unstable cardiovascular disease
6. Congestive Heart Failure (CHF)
7. Clinically significant hepatobiliary or renal disease
8. History of significant CNS injuries within 6 months
9. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
Safety and Efficacy Study of Tendril MRI™ Leads in Standard Bradycardia Pacing Indication

The purpose of this observational study is the assessment (safety and efficacy) of the St. Jude Medical Tendril MRI™ leads. The Tendril MRI™ leads are a full part of the Accent MRI™ System, consisting of Tendril MRI™ leads and Accent MRI™ pacemaker. The subject population includes patients with a standard bradycardia pacing indication.

Magnetic resonance imaging (MRI) is a diagnostic method to view high quality two and three dimensional images of the body. However, magnetic resonance imaging systems generate three electromagnetic fields that are used to produce an image. These include a static magnetic field, a time varying gradient magnetic field, and a radiofrequency field. All three of these fields interact with implanted devices and could create hazards for the device, the patient, or both. Due to these issues, currently marketed pacemaker systems may be contraindicated for use in an MRI environment.

St. Jude Medical has developed a system, the Accent MRI™ system, comprised of the Accent MRI™ device and the Tendril MRI™ lead, and an investigational MRI Activator™, designed to mitigate such interactions.

Eligibility Criteria:
Inclusion Criteria:

* Approved Class I or Class II indication per: European Society of Cardiology (ESC) guidelines for implantation of a dual chamber pacemaker or single chamber pacemaker, OR American College of Cardiology (ACC) / American Heart Association (AHA) / Heart Rhythm Society (HRS) guidelines for implantation of a dual chamber pacemaker or single chamber pacemaker
* Require a new Accent MRI™ pacemaker and Tendril MRI™ lead (either initial implant or complete system change out with no abandoned devices).
* Is ≥ 18 years of age.
* Able to provide written informed consent prior to any investigational related procedure.
* Willing and able to comply with the prescribed follow-up tests and schedule of evaluations.

Exclusion Criteria:

* Have an existing pacemaker or ICD (abandoned devices and/or leads are not allowed. A new pacemaker and lead or complete system change out is required for enrollment).
* Have an existing active implanted medical device (e.g., Implantable Cardioverter Defibrillator (ICD), neurostimulator, etc.).
* Have a non-MRI compatible device or material implant (e.g., intracranial aneurysm clip, non-MRI compatible devices or material, metals or alloys, etc.).
* Have a lead extender, plug or adaptor.
* Have a prosthetic tricuspid heart valve.
* Are currently participating in another investigational device or drug investigation.
* Are allergic to Dexamethasone sodium phosphate (DSP).
* Are pregnant or planning to become pregnant during the duration of the study.
* Have a life expectancy of less than 12 months from Screening due to any life-threatening condition
Ibuprofen Versus Indomethacin Following Emergent Cerclage Placement

Cervical insufficiency is defined as painless cervical dilation in the second trimester. Cervical insufficiency can ultimately lead to second trimester loss of pregnancy. Cerclages are utilized in pregnancies affected by cervical insufficiency in order to prolong gestational latency. There have been several studies investigating the efficacy of perioperative medications for cerclage placement and the effects they have on gestational latency. Some such studies have found that perioperative indomethacin in combination with antibiotics have significantly increased gestational latency when compared to placebo. Indomethacin has traditionally been the tocolytic of choice with cerclage placement. At our hospital, ibuprofen has been the tocolytic of choice for cerclage placement secondary to pharmacy availability. Our study aims to evaluate whether gestational latency differs among patients undergoing emergent cerclage whether they receive perioperative ibuprofen or indomethacin.


Eligibility Criteria:
Inclusion Criteria:

* Viable, singleton pregnancy
* ≥ 18 years old
* Gestational age 16 weeks 0/7 days - 23 week 6/7 days (inclusive)
* Intact membranes at time of enrollment
* Planning to deliver at Woman's Hospital
* Exam or ultrasound indicated cerclage placement

Exclusion Criteria:

* Contraindication to treatments (i.e. ibuprofen or indomethacin)
* Unwilling to be randomized to treatment
* Prophylactic cerclage placement
* Temperature greater than 100.4
* Known major fetal congenital anomaly
* Prior cerclage placement during the current pregnancy
* Recent (within 7 days) receipt of ibuprofen or indomethacin
Specialty Mental Health Probation in North Carolina

Specialty mental health probation for offenders with severe mental illness has been widely disseminated; however, randomized studies are needed to determine its effectiveness. The purpose of the study is to test the feasibility and efficacy of specialty mental health probation (SMHP) for probationers with mental illness in North Carolina. 320 adult probationers with mental illness in will be randomly assigned to specialty mental health probation (experimental condition) or usual probation (control condition). Probationers assigned to the experimental condition will be supervised by specialty mental health probation officers, who will have reduced caseloads and advanced training in mental health and other topics. Probationers assigned to the control condition will receive standard probation. Criminal justice and mental health outcomes will be examined.

Specialty mental health probation for offenders with severe mental illness has been widely disseminated; however, randomized studies are needed to determine its effectiveness. The purpose of the study is to test the feasibility and efficacy of specialty mental health probation (SMHP) for probationers with mental illness in North Carolina. 320 adult probationers with severe mental illness in will be randomly assigned to receive specialty mental health probation (experimental condition) or standard probation (control condition). Probationers assigned to the experimental condition will be supervised by specialty mental health probation officers, who will have reduced caseloads and advanced training in mental health and other topics. Probationers assigned to the control condition will receive standard probation. Criminal justice and mental health outcomes will be examined.

Eligibility Criteria:
Inclusion Criteria:

* Qualifying diagnosis of severe mental illness - schizophrenia, bipolar disorder, major depression, post-traumatic stress disorder + on probation in North Carolina + capable of passing study competency quiz administered by the research team

Exclusion Criteria:

* None
The Effect of Walking Meditation Training on Glycemic Control and Vascular Function in Patients With Type 2 Diabetes

Walking Meditation training would yield more favorable adaptations than walking alone in improving glycemic control and vascular function in patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria included type 2 diabetes (as defined by the American Diabetes Association), a baseline glycosylated hemoglobin (HbA1c) value of 7-9%, and no previous exercise training in the past 6 months. All participants were free from diabetic nephropathy, diabetic retinopathy, severe diabetic neurophathy, severe cardiovascular and cerebrovascular diseases.

Exclusion Criteria:

* Participants were excluded if they dropped out or completed less than 80% of the training schedule.
High Dose PET/CT-guided Intensity Modulated Radiotherapy and Concurrent Chemotherapy in Esophageal Cancer

To assess the efficacy and feasibility of high-dose intensity-modulated radiotherapy with concurrent weekly paclitaxel and cisplatin for patients with locaregionally esophageal cancer

Standard dose chemoradiotherapy (SCRT) results in poor local control for localregionally advanced esopgageal cancer patients. Most local failures occur in the gross tumor volume.\[F-18\]-fluorodeoxyglucose (FDG) PET/CT can identify residual metabolic disease (RMD). Hyperfractionated radiotherapy allows for delivering a higher dose without increasing late toxicity. Our previous phase I radiation dose escalation trial demonstrated that 86 Gy could be safely delivered to the RMD with concurrent weekly paclitaxel and cisplatin in advanced esophageal cancer.The aim of this phase II study is to examine the efficacy of this regimen.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have FDG-avid and histologically or cytologically proven esophageal cancer.
* Patients must be deemed unresectable disease or patient is not deemed operable due to medical reasons.
* Eastern Cooperative Oncology Group （ECOG） performance status 0 to 2 No prior radiation to the thorax that would overlap with the current treatment field.
* Patients with nodal involvement are eligible
* Adequate bone marrow, renal and hepatic functions as assessed by the following: Hemoglobin \>/= 10.0 g/dl, Platelet count \>/= 1 00,000/ mm\^3,absolute granulocyte count (AGC) ≥2 × 10\^9 cells/L,bilirubin and Aspartate transaminase ≤1.5 ×upper limit of normal (ULN), Creatinine \</ =1 .5 times ULN.
* A signed informed consent must be obtained prior to therapy.
* No prior radiation to the thorax that would overlap with the current treatment field.

Induction chemotherapy is allowed.

Exclusion Criteria:

* The presence of a fistula.
* Prior radiotherapy that would overlap the radiation fields.
* gastroesophageal junction cancer or the lower third esophageal cancer invading the gastric wall.
* Uncontrolled concurrent illness including, but not limited to: Chronic Obstructive Pulmonary Disease(COPD) exacerbation or other respiratory illness, serious uncontrolled infection, symptomatic congestive heart failure (CHF),unstable angina pectoris, uncontrolled hypertension,or psychiatric illness/social situations that would limit compliance with the study requirements.
* Known hypersensitivity to paclitaxel.
* Any other condition or circumstance that would, in the opinion of the Investigator, make the patient unsuitable for participation in the study.
* Acquired Immune Deficiency Syndrome.
* Conditions precluding medical follow-up and protocol compliance