cyrilzakka/clinical-trials huggingface dataset:
Ultrasound of Diaphragmatic Musculature in Mechanically Ventilated Patients.

Muscle weakness and dysfunction are common problems in patients hospitalized in the intensive care unit. Respiratory muscle weakness during mechanical ventilation was recognized a state of muscular fatigue. The terminology 'ventilator-induced diaphragmatic dysfunction' (VIDD) originally was introduced to describe these effects of mechanical ventilation and respiratory muscle unloading on the diaphragm.

Ultrasonography is becoming increasingly popular management of ICU patients. It is a simple, non-invasive and safe imaging technique that can be used for the assessment of distinctive diaphragmatic characteristics.

Parameters such as amplitude and velocity of contraction, which can be assessed using M-mode ultrasound. In addition, static and dynamic (thickening fraction during inspiration) diaphragmatic thickness can also be measured by ultrasonography.

The aim of this study is to evaluate the effect of different modes of mechanical ventilation on diaphragmatic thickness using ultrasonography and the relation between time of mechanical ventilation and the percentage of change of diaphragmatic thickness in head trauma patients subjected for mechanical ventilation (\>2 days) intensive care unit.

Modes of ventilation will be used in the study are:

* Pressure controlled mandatory ventilation mode (P-CMV).
* Pressure synchronized intermittent mandatory ventilation mode (P-SIMV).
* Pressure support (PS) mode.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status grades I and II.
* Glasgow coma scale \< 8.
* Selections of patients need mechanical ventilation (\>2 days).
* Head trauma patients.

Exclusion Criteria:

* History of diaphragmatic disease
* Neuromuscular disease
* Anatomical malformation of the diaphragm.
* Patients with chest disease
* Diabetic patients.
* Chest trauma
* Chest malignancy.
* Use of non-invasive ventilation before the start of invasive ventilation.
* Selection of patients of short period of mechanical ventilation (\< 2 days).
* Hemodynamic instability.
* Morbid obesity (body mass index \> 40 kg/m2).
Development of Knee Osteoarthritis After Arthroscopic Partial Resection of Degenerative Meniscus Tear

It has been previously demonstrated that the risk for the development of knee osteoarthritis is increased after both meniscus tear and meniscectomy. However, it is still unclear whether this is due to the meniscus tear per se, the surgery, or whether the development of knee osteoarthritis is completely independent of the two. Accordingly, the aim of the study is to investigate the effect of arthroscopic partial meniscectomy on the development of knee osteoarthritis 2 to 10 years after the procedure.

It has been previously demonstrated that the risk for the development/progression of knee osteoarthritis is increased after both meniscus tear and meniscectomy. However, it is still unclear whether this is due to the meniscus tear per se (i.e., adverse mechanical effect on knee cartilage), the surgery (resection of the meniscus, and subsequent loss of cushion within the knee), or whether the development of knee osteoarthritis is completely independent of the two.

Accordingly, the aim of the study is to investigate the effect of Arthroscopic partial meniscectomy on the development of knee osteoarthritis 2 to 10 years after the procedure.

Patients included in the study will be randomized into one of two groups: arthroscopic partial meniscectomy and diagnostic arthroscopy (sham-surgery). The presence of knee osteoarthritis will be assessed preoperatively and 2, 5, and 10 years after the operation.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 35 to 65 years of age.
2. A pain located on the medial joint line of the knee that has persistent at least for 3 months.
3. Pain that can be provoked by palpation or compression of the joint line or a positive McMurray sign.
4. Tear of the medial meniscus on MRI.
5. Degenerative rupture of the medial meniscus confirmed at arthroscopy.

Exclusion Criteria:

1. Acute, trauma-induced onset of symptoms.
2. Locking or painful snapping of the knee joint.
3. A surgical operation performed on the affected knee.
4. Osteoarthritis of the medial compartment of the knee (determined by clinical criteria of the ACR).
5. Osteoarthritis on knee radiographs (Kellgren-Lawrence \> 1).
6. Acute (within the previous year) fractures of the knee.
7. Decreased range of motion of the knee.
8. Instability of the knee.
9. MRI assessment showing a tumor or any other complaint requiring surgical or other means of treatment.
10. Arthroscopic assessment showing anything other than a degenerative tear of the medial meniscus requiring surgical intervention.
Recombinant Zoster Vaccine in Stable SLE Patients

The risk of herpers zoster reactivation is higher in SLE patients than general population. It has shown that mild or even inactive patients could also have varicella zoster virus (VZV) infections, and they account for about two-thirds of the events. And our previous study indicated that recent various VZV infection was associated with increased risk of disease flares. The risk of virus reactivation limited the use of live-attenuated shingles vaccine in SLE patients, especially in whom with high dose of prednisone or immunosuppressants. Whether the introduction of recombinant zoster vaccine could reduce the risk of zoster reactivation in lupus patients is to be explored in this study.

Systemic lupus erythematosus (SLE) is a chronic systemic autoimmune disease that requires long-term corticosteroid and/or immunosuppressive agents. Thus lupus patients are immunocompromised patients, and the incidence of herpes zoster is higher than general population (asian population 32.5-91.4/1000 person-years vs general population 2.58-4.89/1000 person-years). Patients with active SLE are more susceptible because they require stronger immunosuppressive therapy. However, even mild or even stable lupus patients are highly susceptible, and they account for about two-thirds of the events. In addition, herpes zoster may trigger lupus flare. A case-control study showed a close correlation between herpes zoster reactivation and the diagnosis of lupus, and our previous studies indicated that recent VZV infection was associated with increased risk of disease flares. The risk of virus reactivation limited the use of live-attenuated shingles vaccine in SLE patients, especially in whom with high dose of prednisone or immunosuppressants. Whether the introduction of recombinant herpes zoster could reduce the risk of zoster reactivation in lupus patients is to be explored in this study.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 50 years old
2. The disease status is stable (score≤ 6 at screening on SELENA-SLEDAI); no British Isles Lupus Assessment Group (BILAG) A and no more than one BILAG B;
3. A stable treatment regimen with fixed doses of prednisone (≤ 20mg/day), antimalarial, or immunosuppressive drugs (azathioprine/mycophenolate mofetil/ methotrexate/ciclosporin/tacrolimus/leflunomide/belimumab);
4. Sign the informed consent.

Exclusion Criteria:

1. Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) \> 2 times upper normal limits; creatinine clearance rate \< 60ml/min;
2. Exposure to cyclophosphamide within the past half year.
3. Exposure to rituximab within the past one year.
4. History of herpes zoster within the past three months;
5. Pregnancy or lactation;
6. History of malignancy.
Mindfulness Intervention in Orthopedic Trauma Patients

This project a single-site 3-arm parallel group randomized clinical trial conducted at a tertiary level 1 trauma center among patients undergoing operative fixation of a lower extremity fracture.


Eligibility Criteria:
Inclusion Criteria:

* Age at presentation between 18 and 65 years
* Acute lower extremity fracture to be operatively managed
* Glasgow Coma Scale of 15
* English speaking
* Willingness to participate in study

Exclusion Criteria:

* Cognitive impairment
* Pregnant or lactating woman
* Current incarceration
* Planned secondary procedure
Weight Management Demonstration Project: HEALTH

The study investigated the effectiveness and cost-effectiveness of a cognitive and behavioral weight management program, complemented by an interactive Web site and brief telephone coaching, implemented among TRICARE non-active-duty beneficiaries.

A total of 1,755 participants from four Midwestern states were randomized to one of three randomized controlled trial groups with increasing intervention intensity: mailed material and basic Web access (RCT1), plus an interactive Web site (RCT2), plus brief phone- and Web-based coaching support from health lifestyle coaches (RCT3). The study assessed changes in participants' weight, blood pressure, diet, and physical activity from baseline to 6, 12, and 15 to 18 months. Analyses estimated overall cost savings and calculated the cost-effectiveness ratio of each randomized controlled trial compared with a "do-nothing" alternative as the cost per quality-adjusted life year.

Lifestyle modification interventions that promote healthful eating habits and physical activity can be effective in producing weight losses of 4% to 9% of initial bodyweight. If maintained, this level of weight loss can reduce hypertension, high blood glucose, and elevated lipids. However, weight losses often plateau after 6 months, and weight regain begins after 12 months. Accordingly, there is interest in interventions, such as Web-based reinforcement and brief counseling to maintain weight loss over time and in the relative cost-effectiveness of program delivery modes.

Most obesity treatment programs focus on outcomes for individuals without assessing population-based cost savings. This study suggests that a broader perspective can help to identify the benefit of weight management in adult populations. Accordingly, this study assessed the cost-effectiveness of a weight management program in a population of adults served by a large health care system-the TRICARE Management Activity (TMA), the agency that manages the TRICARE health care benefits for active-duty service members, retired service members, their families, National Guard/Reserve members, and their families. The annual direct medical costs of overweight/obesity for beneficiaries enrolled in TRICARE Prime are estimated to exceed $1.1 billion. This study investigated the effectiveness and cost-effectiveness of methods to deliver a cognitive-behavioral weight loss intervention.

Eligibility Criteria:
Inclusion Criteria:

* TRICARE Prime non-active-duty beneficiaries
* Body Mass Index of 25 to 50
* Living in 4 midwestern states (TRICARE region)

Exclusion Criteria:

* Not able to engage in physical activity
* Pregnant
* Body mass index greater than 50
* Body mass index less than 25
* Human immunodeficiency virus infected
* current cancer
Multi-parametric Imaging in Personalized Radiotherapy

The study consists in the retrospective and prospective collection of imaging data (along with clinical information related to treatment) of skull-base chordoma patients treated with particle therapy, to derive imaging biomarkers which, integrated with advanced mathematical models, will allow predicting treatment outcome on a multi-scale basis.

The study design consists of the retrospective collection of routinely-acquired data (CT, MRI and dose maps, along with relevant clinical information) and the prospective acquisition of optimized non-invasive MR imaging data, of skull-based chordoma patients treated with particle therapy (PT) at the National Center for Oncological Hadrontherapy (CNAO, Pavia, Italy).

This data will be stored in a proper repository under CNAO's control, shared with Politecnico di Milano through encrypted channels, and it will be used to implement mathematical models able to predict treatment outcome at different scales (macroscopic, microscopic and radiobiological).

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed diagnosis of chordoma of the skull base
* Particle therapy with curative intent
* Karnofsky Performance status greater than or equal to 60
* Patients with macroscopic disease detectable at pre-radiotherapy imaging
* Patients undergoing PT with standardized treatment procedures
* Patients who have signed the written informed consent for research

Exclusion Criteria:

* Metastatic disease
* Palliative treatment
* Other malignancies with disease-free interval \< 5 years (excepting pre- cancerous lesions)
* Pregnancy
* Simultaneous CHT or Immunotherapy
* Extensive metal instrumentation/implants
* Patients with autoimmune diseases (ADs) -including collagen-vascular (CVD) and inflammatory bowel (IBD)
Wheelchair Mobility Assessment of Individuals With Spinal Cord Injury

The specific aims of this study are: 1) to assess the test-retest reliability of a modification of an existing wheelchair propulsion assessment and 2) validate the modification against traditional measures of physical strength, power, and endurance in a group of persons with spinal cord injury (SCI).

The ability to independently self-propel and transfer oneself is a crucial component of daily life for individuals with a spinal cord injury. This ability is related in part to an individual's strength, power, and endurance, but it is unknown which of these measures is most important to achieve a high level of wheelchair function. Identification of which physical performance parameters are best related to wheeled mobility performance is essential in developing interventions to improve said performance. Currently, clinic-friendly assessments of a person's wheeled mobility ability do not exist. We have developed a modified, clinic-friendly version of validated wheelchair mobility assessment that can be completed in most clinics. Before it can be implemented by clinicians its reliability must be established. Crossvalidating it against standard measures of physical performance will allow for the identification of the most appropriate exercise interventions to improve independent wheeled mobility.

Eligibility Criteria:
Inclusion Criteria:

* Spinal Cord Injury
* American Spinal Injury Association Impairment Scale (AIS) A-D
* Self-reported ability to self-propel themselves in a manual wheelchair
* Age 18 or older

Exclusion Criteria:

* surgery within 6 months
* pressure ulcer within 3 months
* upper limb pain that limits completion of exercise
* recurrent acute infection or illness requiring hospitalization or IV antibiotics
* pregnancy
* previous myocardial infarction or cardiac surgery
Effectiveness of Diaphragmatic Breathing on Reflux Symptoms in Outpatients

Researchers are trying to determine if abdominal breathing exercises can reduce symptoms associated with GERD (Gastroesophageal reflux disease).

Much like the pelvic floor controls urinary incontinence the "abdominal roof" made of the diaphragm appears to have the ability to control reflux. Other studies have had positive results but from extensive training of outpatients. Our population comes from ambulatory outpatients from family medicine at MCJ. After consent they fill out a reflux disease questionnaire (RDQ) a valid instrument for measuring symptoms of reflux. Subjects are educated on the basic concept of the study and then instructed in isolated diaphragm contraction breathing. once they are proficient they are asked to continue this program 3 x 10 repetitions, 3 times per day supplemented by 10 more repetitions after each meal to reduce post prandial symptoms.

Follow up is done at 1, 3 and 6 months and includes reassessment via the RDQ and an assessment of estimated volume of exercise compliance.

Eligibility Criteria:
Inclusion Criteria:

* Adults with complaints of GERD, reflux, and/or heartburn symptoms

Exclusion Criteria:

* None
Supine Versus Left Lateral Tilted Position During Cesarean Delivery

In this study, we will investigate the effect of left lateral tiling performed after spinal block on maternal hemodynamics compared to ordinary supine position

Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Aortocaval compression is one of the theoretical mechanisms precipitating for post-spinal hypotension (PSH) for CD. Positioning of the patients in the left lateral tilted position after preforming spinal block was frequently considered a standard protocol for minimizing aortocaval compression and improve maternal hemodynamics during CD; however, the latest Cochrane database review reported that there is no adequate evidence to support any positioning protocol for prevention of PSH. Moreover, a recent study was conducted in full term pregnant women reporting no improvement in cardiac output with left lateral tilting. In this study, the effect of left lateral tiling performed after spinal block on maternal hemodynamics will be compared to ordinary supine position.

Eligibility Criteria:
Inclusion Criteria:

* full term
* singleton pregnant women
* scheduled for elective cesarean delivery

Exclusion Criteria:

* Cardiac morbidities
* hypertensive disorders of pregnancy
* peripartum bleeding
* baseline systolic blood pressure (SBP) \< 100 mmHg
* body mass index \> 35
Antibiotic Therapy of Acute Uncomplicated Colonic Diverticulitis

The purpose of this study is to evaluate if antibiotic therapy is necessary for treatment of uncomplicated colonic diverticulitis.

The hypothesis is that Patients with acute uncomplicated colonic diverticulitis will recover the condition without antibiotic therapy and the lack of antibiotic therapy will not lead to complications.

The patients will be randomized to conservative treatment with and without antibiotic therapy.


Eligibility Criteria:
Inclusion Criteria:

* adults with CT sign of acute colonic uncomplicated diverticulitis
* elevated CRP and LPK
* Temp.38c or more

Exclusion Criteria:

* patients with peritonitis, sepsis or CT- sign of complicated diverticulitis with abscesses or free abdominal air
* pregnancy
* immunological incompetence and immunosuppressive therapy
Effectiveness of a Novel Gaming System on Post-operative Rehabilitation Outcomes After Total Knee Arthroplasty

This study aims to evaluate the effectiveness of a novel, game-based rehabilitation system, consisting a sensor-equipped knee sleeve and a mobile application, on rehabilitation outcomes after Total Knee Arthroplasty (TKA) surgery, when compared to conventional rehabilitation; where patients learn and perform rehabilitative exercises using printed brochures.

This is a randomized controlled trial investigating the effectiveness of a novel, game-based rehabilitation system, consisting a sensor-equipped knee sleeve and a mobile application, on rehabilitation outcomes after Total Knee Arthroplasty (TKA).

All patients receiving TKA will be screened for eligibility. Patients who meet inclusion criteria and provide informed consent will be allocated to either intervention or control group using block randomization. A study team member blinded to subject characteristics will allocate subjects to either group.

Subjects in the intervention group will be guided to do their post-TKA rehabilitation exercises using the investigator's game-based system, which includes the wearable sensor device and mobile application games. Subjects in the control group will be guided to do their post-TKA rehabilitation exercises using conventional, paper-based exercise brochures.

From post-operative day 1, all subjects who are medically fit for physiotherapy will receive 2 sessions of physiotherapy, daily; for at least the first 3 post-operative days. The first session consists of individualized physiotherapy that includes bed exercises and ambulation training. In the second session of physiotherapy, subjects will perform their bed exercises using the game-based system or paper-based exercise brochures. Upon discharge, subjects in the intervention group will continue home-based rehabilitation exercises using the game-based system, while those in the control group continue to use the exercise brochures.

Eligibility Criteria:
Inclusion Criteria:

* First, elective, unilateral TKA operation completed in Tan Tock Seng Hospital
* At least two days of inpatient stay
* Discharge to own or carer's home
* Adults \>50 years old
* Able to understand and follow instructions consistently

Exclusion Criteria:

* Post-operative infections or wound complications
* Cognitive impairment
* Sensitive/ broken, Irritable skin around operative knee
* Previous TKA on same or opposite knee
* Pregnant women
* Pre-existing skin conditions e.g. eczema
* Poor wound status e.g. poor wound closure or condition
Ultrasound Versus Fluoroscopy-guided Selective Lumbar Nerve Root Injection

The study is conducted to compare pain relief, accuracy and safety and radiation exposure of selective lumbar nerve root injection for lumbar radicular pain using ultrasound guidance versus fluoroscopy guidance

Radicular pain is believed to be induced by irritation or inflammation of a nerve root caused by mechanical pressure or chemical irritation from degeneration herniation or rupture of intervertebral disc .Nerve root steroid injection is the most commonly performed minimally invasive technique for treatment of radicular pain in lumbar spine.The mechanism of action of steroids is to reduce inflammation by reduction in proinflammatory mediators around the nerve root, causing reduction in pain levels . Although Fluoroscopy guided technique is the most widely accepted method in lumbar selective nerve root injection, but recently ultrasound technique has gained acceptance among physicians due its reliability, efficacy, real-time guidance of injection and reduction of radiation exposure. Real-time guidance of injection provided by ultrasonography allows for good identification of the spinous process and adjacent structures such as lamina, zygapophyseal articulations and transverse process allowing for safer and potentially equally effective injection technique. The patients are randomly allocated into two groups; one group will receive injection under fluoroscopy guidance and the other group will receive injection under ultrasound guidance. The two groups are compared in terms of pain relief, accuracy and safety and radiation exposure.

Eligibility Criteria:
Inclusion Criteria:

* adult patients aged 18-60 years .
* Both sexes .
* With unilateral chronic lumbar radicular pain for more than 3 months.
* Cooperative and oriented patients.
* All patients are diagnosed by a neurologist for radicular low back pain through clinical presentation, medical examinations, computed tomography (CT), or magnetic resonance imaging (MRI).

Exclusion Criteria:

* Uncontrolled diabetes.
* Infection at the site of injection.
* Spine fractures.
* Previous back surgery.
* Progressive neurologic disorders.
* Fever.
* Peripheral neuropathy.
* Presence of motor or sphencteric disturbance.
* Bilateral radicular pain.
* Allergy to substance of injection.
* Patients with body mass index (BMI) more than 35.