cyrilzakka/clinical-trials huggingface dataset:
"Psychological Intervention Enhanced by Virtual Reality for the Improvement of Appreciation of Body Functionality in Patients With Chronic Low-back-pain".

The purpose of this study is to test whether a positive body image-based intervention is able to improve pain, disability, interference and emotional distress in people with chronic low back pain.

Patients will receive 4 sessions approaching 5 different clinical modules: Pain Psychoeducation, Body Awareness, Pain Acceptance, Body Appreciation and Functionality and Gratitude. 2 sessions will include virtual reality (VR) environments to enhance the clinical outcomes.

Researchers will analyse changes in the variables of interest after intervention compared to baseline.

The purpose of this intervention is to examine the effects of a positive body image-based intervention using virtual reality to improve pain, interference and emotional distress.

The first session will be dedicated to psychoeducation about pain. Investigators will discuss what chronic pain is, what factors influence pain, chronification, body image and a brief presentation of the modules.

In the second session, a brief introduction to body awareness will be given and a VR environment will be used to carry out a body scan.

In the third session, Acceptance of pain will be worked on and a VR environment will be used to work on some variables related to the chronification of pain, such as paradoxical control or avoidance.

In the fourth session, the modules of Appreciation and Gratitude will be addressed.

Each session will last approximately one hour. First, participants will be screened to check eligibility inclusion/exclusion criteria. Second, eligible participants will complete baseline measures.

The study will be conducted following the principles stated in the Declaration of Helsinki.

The design chosen for the intervention will be a Multiple Baseline Single Case Design (SCD-MB). Data will be analysed by visual and statistical analysis. For visual analysis, the mean and/or median will be used to report the level, trend and stability of the 'within phase' data. For "between-phase" data, "Nonoverlap Statistics" such as "Nonoverlap of All Pairs" (NAP) will be used. For statistical analyses a Cohen's Difference of Means (Cohen's d) will be used to estimate the effect size at the individual level and multilevel analyses for across-case effect sizes.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with low back pain.

Exclusion Criteria:

* Meeting any of the following medical conditions:

  * Spinal tumor, infection or fracture
  * Systemic disease (autoimmune, infectious, vascular, endocrine, metabolic...)
  * Fibromyalgia
  * Cauda equina syndrome
  * History of spinal surgery
  * Musculoskeletal injury of lower extremities
Safety of AMG 706 Plus Panitumumab Plus Chemotherapy in the Treatment of Subjects With Metastatic Colorectal Cancer

The purpose of this study is to characterize the safety and tolerability of AMG 706 plus panitumumab when administered with either FOLFIRI or FOLFOX4 chemotherapy regimens. This is a Phase 1b clinical study.


Eligibility Criteria:
For complete inclusion and exclusion criteria, please refer to the investigator. Inclusion Criteria

1. Competent to comprehend, sign, and date an Institutional Review Board (IRB) approved informed consent form
2. Diagnosis of metastatic colorectal adenocarcinoma (may have received 1 prior chemotherapy regimen for metastatic CRC)
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
4. Adequate hematological function
5. Adequate renal function
6. Adequate hepatic function
7. Life expectancy of greater than or equal to 3 months as documented by the investigator

Exclusion Criteria:

1. More than 1 prior chemotherapy regimen for metastatic CRC
2. Central nervous system (CNS) metastases
3. History of venous thrombosis
4. Myocardial infarction, cerebrovascular accident, transient ischemic attack, grade 2 or greater peripheral vascular disease, congestive heart failure, ongoing arrhythmias requiring medication, or unstable angina within 1 year before study enrollment
5. History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on screening chest computed tomograph (CT) scan
6. Average systolic blood pressure \> 150mm Hg or average diastolic blood pressure of \> 90mm Hg
7. Radiotherapy within 28 days of study enrollment or within 14 days of study enrollment for peripheral lesions
8. Prior AMG 706, oral inhibitors of AMG706, panitumumab, or another anti-EGFr monoclonal antibody (mAb) (e.g., cetuximab \[Erbitux®\] or EMD 72000)
9. Systemic chemotherapy within 28 days before study enrollment
10. Major surgery within 28 days or minor surgery within 7days of study enrollment
11. History of life threatening ventricular arrhythmia (eg, sustained ventricular tachycardia)
12. Female and male subjects of childbearing potential not using adequate contraceptive precautions
13. Participation in therapeutic clinical trials within 30 days before study enrollment
14. Not recovered from all previous therapies
15. Clinically significant open would, ulcer or fracture
16. Any co-morbid medical condition that would increase the risk of toxicity
Generalizability and Spread of an Evidenced-based Fall Prevention Toolkit: Fall TIPS

The goal of our project is to evaluate the effectiveness of the Fall TIPS program with regard to inpatient falls and fall-related injuries.

This study will explore the effectiveness of the Fall TIPS (Tailoring Interventions for Patient Safety) program in regard to inpatient falls and fall-related injuries in three large hospital systems with different Electronic Medical Records (EMRs). We will collect and evaluate data on the perceived effectiveness of the Fall TIPS implementation process along with stakeholders' views of the toolkit. We will use an interrupted time series approach for evaluation of pre and post-Fall TIPS data related to patient falls and injurious falls. We will systematically analyze the costs and benefits of the Fall TIPS program from two perspectives: (1) the hospital, and (2) society as a whole. The hospital perspective will assist other hospitals in evaluating the decision to invest in implementing and adopting the Fall TIPS program, while the societal perspective will be instructive from a public policy stance

By the end of the study, we will produce a set of recommendations to facilitate adoption, implementation, and maintenance of the Fall TIPS program, along with a manuscript that will answer the following research questions:

1. Does Fall TIPS reduce the incidence of falls and injurious falls?
2. Were there differences in Fall TIPS effectiveness among different healthcare systems and hospitals as well as variations associated with differing patient characteristics (gender, age, ethnic/racial), EMRs, and degrees of adherence with the Fall TIPS protocol?
3. Do the benefits associated with Fall TIPS outweigh the costs from hospital and societal perspectives?
4. What Fall TIPS components were most/least useful and what recommendations will improve the overall utility and ease of use of the Fall TIPS Toolkit?
5. What aspects of the implementation model were most/least helpful for promoting Fall TIPS adoption and use?

Eligibility Criteria:
Inclusion Criteria:

* All adult patients admitted to medical, surgical, neurology and oncology units at participating hospitals during the time of the study

Exclusion Criteria:

* Anyone who does not meet the inclusion criteria
Surveillance of Azole Resistance in Aspergillus Isolates in Taiwan

Primary objectives:

1. To investigate the prevalence of azole resistance in Aspergillus clinical isolates collected in participating hospitals in Taiwan
2. To investigate the prevalence of azole resistance in Aspergillus environmental isolates in Taiwan
3. To characterize the molecular mechanisms of azole resistance in Aspergillus isolates in Taiwan
4. To investigate the clonality of Aspergillus clinical and environmental isolates in Taiwan
5. To describe the genetic relationships between local resistant strains with global strains

Secondary objective:

1. To describe the clinical characteristics and treatment outcome of patients with proven or probable invasive aspergillosis
2. To evaluate the clinical impact of azole resistance in patients with proven or probable invasive aspergillosis in a case-control study

Cumulative evidence described the emergence and geographical expansion of azole-resistant Aspergillus fumigatus associated with azole treatment failure. Multiple amino acid substitutions in the cyp51A gene have been described to be associated with azole resistance that emerges during azole treatment, while a resistance mechanism, TR34/L98H mutation in cyp51A, has been linked to the agricultural use of azole fungicides in Europe, which have also been widely used in Taiwan for years. The current prevalence of azole-resistant Aspergillus isolates and mechanisms of azole resistance in Taiwan is not clear. Considering the potential of geographic migration of resistant isolates from neighboring countries and the possibility of emergence of locally revolved resistant strains, this 2-year multi-center project aims to investigate the prevalence rate of azole resistance in Aspergillus clinical and environmental isolates, to determine the molecular mechanisms of azole resistance, and to describe the clinical characteristics and treatment outcome of Aspergillus diseases in Taiwan. Clinical and environmental Aspergillus isolates will be collected and examined, and clinical data from patients with Aspergillus diseases or colonization will be retrieved and analyzed. Through this study the investigators anticipate increase in awareness of prevalence and impact of azole resistance in patient safety in participating hospitals. In addition, the investigators may update Taiwan treatment guideline for aspergillosis on the basis of these evidence and knowledge.

Eligibility Criteria:
For primary objectives

Inclusion Criteria:

* Patients with one or more clinical specimens culture positive of Aspergillus

Exclusion Criteria:

* Is not a human pathogen of Aspergillus
* no clinical data available

For secondary objectives (a case-control study in a 1:4 ratio)

Inclusion Criteria:

* patients with proven or probable invasive aspergillosis

Case patients: patients infected by azole-resistant isolates Control patients: patients infected by azole-susceptible isolates
Assess the Effect of Erythromycin on the Rate of Success in Placement of a Self-propelled Feeding Tube

The purpose of this study is to assess the effect of erythromycin on the Rate of Success in Placement of a Self-propelled Feeding Tube.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-80 years
* Having pancreatitis
* Require jejunal enteral nutrition

Exclusion Criteria:

* Known impaired peristalsis (critically ill patients, postoperative patients, history of surgery of the stomach/duodenum)
* Pregnancy
* Hypersensibility to erythromycin
* Cardiac arrhythmias with a prolonged QT-time
* Simultaneous usage of drugs impairing peristalsis
A Study of Perjeta (Pertuzumab) in Combination With Herceptin (Trastuzumab) in Participants With Metastatic Breast Cancer

This study will evaluate the efficacy and safety of Perjeta (pertuzumab) in combination with Herceptin (trastuzumab) in participants with metastatic breast cancer who have progressed on trastuzumab-based therapy (Cohorts 1 and 2), and will make a preliminary assessment of the efficacy and safety of single-agent pertuzumab (Cohort 3). Objective response rate and clinical benefit will be assessed. Pertuzumab will be administered at an initial dose of 840 milligrams (mg) intravenously (IV) on Day 1, followed by 420 mg IV every 3 weeks. Trastuzumab will be administered at the same schedule the participant was following before entry into the study. An additional cohort of participants at certain centers will receive pertuzumab monotherapy at an initial dose of 840 mg IV on Day 1, followed by 420 mg IV every 3 weeks. These participants may have trastuzumab added to the regimen in the event of progression during single-agent pertuzumab treatment.


Eligibility Criteria:
Inclusion Criteria:

* Females greater than or equal to (≥) 18 years of age, with histologically-confirmed HER2-positive breast cancer
* Metastatic breast cancer, with progression on trastuzumab-based therapy as last treatment for metastatic disease
* Less than or equal to (≤) 3 chemotherapy regimens prior to study entry
* Last trastuzumab dose ≤9 weeks before study entry for participants receiving pertuzumab + trastuzumab, and ≥4 weeks for participants receiving pertuzumab monotherapy
* Left ventricular ejection fraction ≥55% at study entry

Exclusion Criteria:

* Previous treatment with an anti-cancer vaccine or any targeted therapy other than trastuzumab
* Brain metastases
* History of any cardiac adverse event related to trastuzumab therapy
* Any other malignancy in the last 5 years, except for basal cell cancer or cancer in situ of the cervix
Outcomes of Surgical Management of Temporomandibular Joint Anterior Disc Displacement Without Reduction

this study will be done to detect the best management of temporo-mandibular joint anterior disc displacement without reduction, for diagnosis, we use MRI on the TMJ to detect status of the disc and joint space, for management, we try to select best operation as discopexy, discectomy with or without replacement, and we follow up the patients and detect side effects and effect for each operation

Discopexy is a procedure in which the displaced disk is freed by the surgeon and lysing adhesions first. The success of the disc repositioning depends on the degree of deformity and the extent of degenerative changes at the time of the arthroplasty. Repositioning the disc restores the condylar movement that was previously blocked by the displaced disc, stabilizes the joint, and improves nutrition and lubrication of articular cartilage. In addition, the workload of the masticatory muscles is reduced when the obstructing disc is repositioned. TMJ disc repositioning surgery seems to improve pain, mouth opening, and patient quality of life

Temporomandibular Joint (TMJ) arthroscopy is one of the most advanced and a minimally invasive technique involving optical instrumentation and prescribed surgical armamentarium, used for the treatment of the TMJ disorders. It is one of the most popular and effective methods of diagnosing and treating TMJ disorders since TMJ disorders have become an increasingly widespread problem in our society. Also, it enables the surgeon to visualize the joint and, therefore, contributes to the diagnosis of the internal pathological condition of the joint and allows inspection of a surgically undisturbed joint both at rest and in function

Eligibility Criteria:
Inclusion Criteria:

* This study will include patients diagnosed as anterior disc displacement without reduction based on clinical manifestations and MRI.

Exclusion Criteria:

* o Patients with severe osteoarthritic changes of the condyle and glenoid fossa.

  * Patients with bony ankylosis.
  * Patients with infection or tumors around joint area.
  * Patients with previous TMJ surgery.
  * Any patient with systemic inflammatory disease or myopathic disease affecting TMJ such as Rheumatoid Arthritis And Systemic Lupus Erythromatosis.
  * Patients unfit for intervention.
  * Patients who refused to share in the study.
Evaluating the Feasibility and Effectiveness of Using a Smartphone Application During Rehabilitation in Patients After Total Knee Replacement

Despite best efforts to provide standardized and effective rehabilitation sessions post-total knee replacement (TKR), there are a few factors that may result in sub-optimal recovery in this group of patients. There is a need to develop innovative rehabilitation strategies that (i) provide patients with accurate cues allowing for better compliance and exercise performance, (ii) allow for therapists to ensure continuity of care, monitor compliance, and identify deviation from recovery trajectories post-discharge, prior to their first outpatient appointment, and (iii) reduce reliance on manpower and variability during rehabilitation sessions.

Technological solutions that empower patients and allow home-based rehabilitation to take place without the need for real-time human supervision could be the key to improving effectiveness and lowering costs. A mobile application which detects key landmarks on the body for human pose estimation will allow patients to perform their rehabilitation exercises with real-time feedback allowing for proper execution of the exercises. Physiotherapists will be able to access the data generated from the exercise session via a command centre to monitor patients' recovery progress and compliance.

The primary aim of this pilot study is to evaluate the feasibility of using a mobile application during rehabilitation in patients after a TKR surgery. The secondary aim is to study the effects of using a mobile application during rehabilitation on knee functional status, exercise self-efficacy, and treatment satisfaction after TKR surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Primary unilateral total knee replacement
2. Age \>= 45 years
3. Under the Enhanced Recovery After Surgery (ERAS) programme (discharge on post-operative day 0/1)
4. Willingness to be randomized to either mobile application group or standard hospital-based rehabilitation group
5. Ability to provide informed consent
6. Is technologically savvy - at least 6 months' experience using a smartphone and able to key in data into a smartphone
7. English-speaking

Exclusion Criteria:

1. Rheumatoid arthritis and other systemic arthritis
2. A previous history of stroke and other major neurological conditions
3. An intention to transfer to step-down care facilities post-operatively or intention to continue outpatient physiotherapy service at another institution
4. Unable to perform 5 repetitions of inner-range quadriceps exercise
Renal Perfusion, Filtration and Oxygenation During Cardiopulmonary Bypass (CPB)

Acute kidney injury is a common complication after cardiac surgery with cardiopulmonary bypass (CPB). This study aims to investigate the effects of CPB on renal perfusion, filtration and oxygenation.

After approval of the regional ethics committee, patients (n=16) undergoing combined cardiac surgery procedures during normothermic CPB will be included after informed consent. Systemic and renal variables will be measured by pulmonary artery and renal vein catheters. Glomerular filtration rate (GFR) will be measured by renal extraction of 51Cr-EDTA and renal blood flow (RBF) by the infusion clearance technique for para-aminohippuric acid (PAH) corrected for by renal extraction of PAH. Repeated measures ANOVA followed by Fisher's PLSD post-hoc test were used for statistical analyses

Eligibility Criteria:
Inclusion Criteria:

* Preserved left ventricular function (LVEF \> 50%)
* Normal preoperative S-creatinine

Exclusion Criteria:

* Contraindications to radiocontrast
* Cardiac transplantation och dissection
Feasibility and Efficacy of a Brief Mindfulness-Based Intervention SMOKING INTERVENTION VIA THE INTERNET

The current study will examine both the feasibility and efficacy of a single session, web-based mindfulness-based intervention for smoking cessation. The study will explore (1) participants' subjective experiences of the intervention, (2) cravings and negative affect both before and after the intervention, and (3) changes in tobacco use one week and one month following the initial intervention. Further, the study will examine how often participants utilize the intervention between the initial study and follow-up periods.


Eligibility Criteria:
Inclusion Criteria:

* Daily Smoker
* Has a desire to quit or reduce smoking.
* Is not currently involved in another smoking reduction or cessation program.

Exclusion Criteria:

-
Post Marketing Surveillance (PMS) Study of Cresemba in Korea.

The purpose of this study is to observe safety and effectiveness of Cresemba in patients with invasive Aspergillosis or invasive Mucormycosis in Korea during the post-marketing surveillance period as required by Ministry of Food and Drug Safety (MFDS).

In compliance with the Korean New Drug Re-Examination Guidelines, this study aims to collect further observational data on the safety and effectiveness of Cresemba for six years after authorization is obtained in at least 600 subjects under routine clinical practice. As the safety and effectiveness results obtained from the clinical development program of Cresemba are based on randomized trials using specific inclusion and exclusion criteria, data from the present post-authorization study where Cresemba is used in routine clinical practice per approved label is anticipated to provide important information on safety and effectiveness in a real-world population in Korea. This non-interventional study is designated as a PMS study and is a commitment to MFDS.

Eligibility Criteria:
Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

* Patients aged 19 years or older
* Patients with proven or suspected diagnosis of invasive Aspergillosis or invasive Mucormycosis.
* Evidence of a signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria: Patients meeting any of the following criteria will not be included in the study:

* Patients with known hypersensitivity to the active substance of Isavuconazole or to any of the excipients.
* Patients are ineligible as determined by the investigator, such as those with familial short QT syndrome.
* Patients administrating ketoconazole, high-dose ritonavir (\>200 mg every 12 hours) or strong CYP3A4/5 inducers (e.g. rifampicin, carbamazepine, phenytoin) that cannot be discontinued before administration of Cresemba.
Preoperative Anxiety and Music Therapy

Music can reduce anxiety in adult patients awaiting surgical interventions. The study was designed to test the difference in cardiac parameters, anxiety questionnaire, laboratory enzymes, skin resitance between surgical patients listening music vs no sound.

Patients undergoing elective surgical intervention will be allocated in two groups: Group M will listen prerecorded music through an individual headset for 30 min before the induction of anesthesia; Group C will listen no sound through an individual headset for 30 min before the induction of anesthesia The degree of stress and anxiety the patients will be assessed using questionnaire. Laboratory enzymes will be measured.

Heart rate, non invasive arterial pressure, pulse oximetry,skin resistance will be recorded. All the patients will receive continuous ECG holter recording .

To assess the effect of music therapy on the degree of autonomic modulation, HRV will be analyzed with traditional time and frequency measures.

Eligibility Criteria:
Inclusion Criteria:

* Elective surgical patients \>18 years old, after obtaining informed consent

Exclusion Criteria:

* patients with hearing impairment,
* any known psychiatric or memory disorder
* thyroid disease.
* atrial fibrillation
* pace-maker