cyrilzakka/clinical-trials huggingface dataset:
Ultrafiltration in Pediatric Cardiac Surgery: An Observational Cohort Study

Infants and children undergoing cardiac surgery with cardiopulmonary bypass (CPB) can experience systemic inflammation that prolongs post-operative recovery. Ultrafiltration is an intra-opreative technique that is hypothesized to extract circulating inflammatory mediators during the CPB time. There have been only a few small studies looking at a limited number of inflammatory marker profiles in this context. Our institution uses an innovative form of ultrafiltration "subzero-balance simple-modified ultrafiltration" (SBUF-SMUF) throughout the entire CPB time. SBUF-SMUF has been our standard of care for the last 5 years. This observational seeks to describe the clinical and immunologic outcomes of infants and children undergoing cardiac surgery with CBP and SBUF-SMUF.


Eligibility Criteria:
Inclusion Criteria:

* Congenital cardiac patients (\< 30kg) that have been consented to a planned cardiac surgery procedure requiring cardiopulmonary bypass at the IWK Health Centre.
* Patient or family consent to participate in the study.

Exclusion Criteria:

* Patient or family refusal to participate.
* Known genetic syndrome with multi-organ abnormalities and immune dysfunction such as DiGeorge Syndrome, Trisomy 18 or 13, Noonan syndrome.
* Known immunodeficiency syndrome or bone marrow pathology.
* Severe liver disease with abnormal synthetic liver function tests.
Trial of Enteral Nutrition Enriched With Eicosapentaenoic Acid (EPA) in Upper Gastrointestinal Cancer Surgery

This study aims to examine whether providing tube feeding with a formula enriched with omega-3 fats is better than traditional standard tube feeding in terms of preserving nutritional status, improving immune function and reducing medical complications following major upper Gut cancer surgery.

Title A double blinded randomized controlled trial to investigate the effects of an enteral nutritional supplement enriched with Eicosapentaenoic acid on long term nutritional status post operatively specifically the maintenance of lean body mass, and its potential impact on quality of life as well as examining the stress response and immune function and in patients undergoing surgical treatment of esophageal cancer.

Investigational medicinal Product(s):

Prosure (Abbott Laboratories)

Comparator:

Ensure Plus (Abbott Laboratories)

Study Objectives To examine whether prolonged supplementation with a nutritional supplement enriched with Eicosapentaenoic acid is superior to standard nutritional products in terms of promoting anabolism and improving quality of life in patients undergoing surgical treatment of esophageal cancer.

Study Design - Prospective randomized controlled trial.

Primary Endpoints:

* Quality of life Scores using EORTC Questionnaires
* Nutritional status on day 21 post oesophagectomy and/or total gastrectomy(specifically lean body mass) and at out patient follow up

Secondary Endpoints:

* Effects on the immuno-inflammatory response to surgery
* Post operative Clinical outcome including SIRS, sepsis and organ failure

Eligibility Criteria:
Inclusion Criteria:

* Adult (male \& female) patients \>18 years with resectable esophageal cancer

Exclusion Criteria:

* Patients with metastatic disease,
* Non-operable cases,
* Patients requiring chemotherapy/radiotherapy early following surgery,
* Patients with known immunological disorder,
* Emergency esophagectomy cases,
* Patients with cardiac, liver or renal failure,
* Active small intestinal disease eg Crohns disease,
* Allergy to any of the ingredients,
* Uncontrollable Diabetes,
* Use of medications known to affect eicosanoid metabolism in two weeks prior to trial,
* Use of fish oil/n-3 fatty acids,
* Drug Abuse,
* Unable to take preparation for 5 days preoperatively,
* Pregnant women,
* Cessation of enteral feeding for longer than 3 consecutive days post operatively for medical/surgical reasons (e.g. Chyle leaks).
Comparison of SUV Using SPECT/CT Between Grave's Disease Patients and Normal Humans

The purpose of this study is to find out the capacity of standardized uptake value (SUV) using single-photo emission computed tomography and computed tomography (SPECT/CT) in diagnosing Grave's Disease (hyperthyroidism).

Traditionally it is considered that only positron emission tomography(PET) has the ability to obtain standardized uptake value（SUV）while single-photo emission computed tomography(SPECT) does not have. Recently with the developing of technology, the ability of SPECT has been extended.

On the other hand, thyroid imaging by SPECT can only play an auxiliary role in hyperthyroidism diagnosis mainly since it is regarded as nonquantitative. So the investigators design this study to search the capacity and accuracy of SUV provided by SPECT and CT(CT is used for reconstruction algorithm) in diagnosing GD.

This is a multiple-center study containing nine groups in China that use GE Discovery NM/CT, an advanced equipment. Thus, the data can be more accurate and more available.

And this is a perspective clinical trial, taking about eight months. The investigators plan to evaluate at least 50 Grave's Disease(GD) patients and 50 normal humans as contrast in all.

Every GD patient must have been diagnosed and the results of thyroid function tests(such as TSH,FT3,FT4） must be available. If necessary, the patient's rate of iodine uptake should also be known before he/she being included in this study. As for normal people, the results of thyroid function tests should be within the range of normal value.

The data of each participant will be gathered and stored. And the data processing will be done with the help of GE staff, using the software Q.Metrix to get the value of SUVmean, SUVmax. Finally T test will be used in comparison of the differences.

Eligibility Criteria:
For Group of GD Patients:

Inclusion Criteria:

* certainly diagnosed with GD
* no treatment
* sign a informed consent

Exclusion Criteria:

* Inflammatory Hyperthyroidism
* Secondary Hyperthyroidism (since of medicine, thyrotrophs neoplasms and etc)
* Can not finish the check of SPECT/CT
* Refuse to sign a informed consent

For Group of Normal Humans:

Inclusion Criteria:

* without GD
* Adult
* sign a reformed consent

Exclusion Criteria:

* Without normal values of TSH, FT3, FT4
* Can not finish the check of SPECT/CT
* Failed to sign a reformed consent
Efficacy of Magnetic Resonance-guided High Intensity Focused Ultrasound for the Ablation of Breast Cancer

The purpose of the study is to evaluate the efficacy of a dedicated Magnetic Resonance guided High Intensity Focused Ultrasound (MR-HIFU) unit in ablating breast cancer by comparing MR imaging and pathologic specimen after resection.

Single-center, single-arm, non-randomized trial

The dedicated MR-HIFU unit has been shown to be safe and feasible to ablate breast tissue.

The planned study should address the possibility to completely ablate breast cancer with the dedicated breast MR-HIFU unit. The result of the MR-HIFU therapy should be monitored by imaging (contrast enhanced MRI) as well as with histopathological correlation after surgery.

The patient population would consist of female patients with proven breast cancer scheduled for surgical lumpectomy or mastectomy.

The idea is to evaluate a minimal invasive method to treat breast cancer as a potential alternative to surgical resection in the future

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent as documented by signature
* World Health Organization (WHO) performance status≤ 2
* Body weight ≤ 80 kg
* Biopsy proven invasive breast cancer with a size of ≤3.0cm (TNM classification: cT1-2 N0-2 MX ).
* Histological type of tumor: invasive ductal carcinoma (IDC)
* Patient is scheduled for surgical resection of tumor at study site
* Tumor location within the reach of the HIFU transducers with the patient in prone position; distance from skin and pectoral muscle to the tumor ≥ 1.0 cm.
* Target breast fits in the cup of the dedicated MR-HIFU breast system

Exclusion Criteria:

* neoadjuvant systemic therapy
* prior radiotherapy in target breast
* contraindications for MRI
* contraindication for application of gadolinium-based contrast agent
* contraindication for procedural sedation analgesia
* macro-calcifications in or around the targeted tumor
* scar tissue or surgical clips in the direct path of the ultrasound beams
* Women who are pregnant or breast feeding,
* Intention to become pregnant during the course of the study,
* Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases.
* Known or suspected non-compliance, drug or alcohol abuse,
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
* Participation in another study with investigational drug/device within the 30 days preceding and during the present study,
* Previous enrolment into the current study
Pharmacokinetics of Dalteparin in Patients With Impaired Renal Function

Low molecular weight heparins (LMWH) have been shown to be at least as efficient and safe as unfractioned heparin (UFH) in prophylaxis and treatment of venous thromboembolic events and in therapy of acute cardiovascular diseases. LMWH are widely used as safe replacement of oral anticoagulation with vitamin K antagonists (VKA).

Due to their pharmacokinetic characteristics, LMWH tend to accumulate in patients with impaired renal function. Official guidelines recommend therefore to use LMWH controlled by Anti-Xa levels or to use UFH instead of LMWH to provide full therapeutic anticoagulation therapy in patients with severe renal insufficiency.

Although dosage recommendations have been proposed for enoxaparin in patients with renal impairment based on several studies, these data cannot be applied to other LMWH directly due to different pharmacokinetic properties of each drug.

The present study aims to clarify the pharmacokinetics of dalteparin in patients with renal insufficiency, especially addressing the question of accumulation after multiple doses and including patients with severe renal insufficiency and derive a safe and suitable concept for using dalteparin in patients with impaired renal function.


Eligibility Criteria:
Inclusion Criteria:

* Patient starting with dalteparin for prophylaxis OR therapy by order of the treating physician (after having evaluated clinical indication and contraindications).
* Renal function normal OR impaired with or without dialysis therapy according to open study groups
* Age \>= 18 years
* Written informed consent

Exclusion Criteria:

* Pregnancy / Lactation
* Dalteparin or other LMWH already in use for \> 1 day, unless just in use during hemodialysis
* Anti-Xa level before first application of dalteparin \> 0.3 U / ml
* Participation in another study
* Anuria OR glomerular filtration rate \< 10 ml/min without dialysis
* Patient on intensive care unit (ICU)
* Cardiovascular unstable patient or probable need for a quick stop of anticoagulation (e.g. emergency surgery)
* Patient with a disease whose estimated life expectancy is \< 28 days
Non-invasive Brain Stimulation Paired With FES Cycling Post SCI

This project is randomized controlled trial which will explore the effect of pairing repetitive Transcranial Magnetic Stimulation (rTMS) with Functional Electrical Stimulation (FES) Cycling on lower extremity function in people with incomplete spinal cord injury and compare the effects to each one of these interventions alone.

Following a spinal cord injury, people often have decreased strength and balance in their legs, making it difficult to walk. To improve leg function in people with spinal cold injuries, the investigators can use electrical stimulation on muscles while participants are cycling to increase the muscle activation and nerve connections. Another way to improve the nerve connections to the muscles is by stimulating the brain directly. Previous research has looked at the effects of each of these treatments, but they have not been used together. In this study, the investigators will pair both electrical stimulation on the legs during cycling with brain stimulation or a sham brain stimulation to improve recovery and determine if using these methods together results in better outcomes, such as increased walking speed. Participants will attend training sessions for six weeks, twice per week. Each person will first receive the active or sham brain stimulation at the beginning of the session for 30 minutes and then they will receive the electrical stimulation on their legs while cycling for 60 minutes. Participants will be evaluated before the start of the treatment, in the middle of the study, at the final session, and again two weeks after the last session of the treatment. Assessments will include clinical tests of gait, balance, and strength. Inertial Measurement Units (IMU) and a pressure sensor gait mat will be used to evaluate the gait and balance parameters.

Eligibility Criteria:
Inclusion Criteria:

* adult
* having motor incomplete SCI with level C or D on the American Spinal Injury Association Impairment Scale (AIS) with the lesion at any level of the cord resulting from either traumatic or non-traumatic etiology who are at least one-year post-injury.
* having non-progressive SCI
* being able to walk independently for 10 meters without help from another person

Exclusion Criteria:

* other orthopedic or neurological implications that affect the lower extremity function
* contraindications to FES (e.g., implanted electronic devices, unhealed bone fractures, sever contractures, extreme osteoporosis or osteoarthritis)
* contraindications to rTMS (e.g., metal implants, history of seizure, cochlear implants)
A Non-inferiority Evaluation of a Smart-phone Based Cervical Imaging Device.

When a woman has an abnormal pap smear or tests positive for a high risk strain of the HPV virus, the current standard of care includes culposcopic examination of the cervix with biopsy. A culposcope is essentially a microscope for examining the cervix. Culposcopes cost $5-10,000 each. The device being tested in this trial is an adaptor for a smart phone that will cost \~ $125. The larger goal of this line of studies see if the images obtained using the smart phone adaptor are non-inferior to those obtained with standard culposcopes. If the device is found to provide images equal to those of standard culposscopes, it could save thousands of dollars in healthcare expenditure currently that go to the purchase and maintenance of culposcopes. This has potential world-wide applications, especially for resource poor countries. This initial trial is a non-inferiority trial to compare the images obtained with the smart phone based device of those obtained by a standard culposcope

See above.

Eligibility Criteria:
Inclusion Criteria: adult women with abnormal pap smear or HPV virus testing referred for culposcopy -

Exclusion Criteria: none

-
Efficacy of Methylsulfonylmethane Supplementation on Osteoarthritis of The Knee: A Randomized Controlled Study

The aim of this study was to determine the efficacy of methylsulfonylmethane (MSM) in treating patients with knee OA.


Eligibility Criteria:
Inclusion Criteria:

* symptomatic knee OA for at least 6 months according to the clinical criteria of the American College of Rheumatology (ACR)
* radiographic confirmed knee OA according to the Kellgren \& Lawrence scale

Exclusion Criteria:

* acute septic arthritis
* inflammatory arthritis
* any other type of arthritis
* history of knee buckling or recent knee injury
* lack of physical or mental bility to perform or comply with the treatment procedure
* diabetes mellitus
* fibromyalgia or other chronic pain syndromes
* concurrent anti-coagulant/anti-platelet drugs
* arthroscopy or intra-articular injections in the previous 3 months
Effects of Proprioceptive Training With Routine PT on Gross Motor Function in Spastic Quadriplegic CP

The proprioceptive training with a therapy regime enhances the body's somatosensory input that in result changes the body to be more functional in different types of interactions. This study is dedicated to finding out how much proprioception training is helpful in gross motor function level improvement and enhances functional activities of CP children

Proprioception plays an important role in the correct execution of efferent motor performance as 70% of cerebral palsy population have deficit in receiving somatosensory signals3. Tradition physical therapy exercises including strengthening followed by stretching etc. should be reviewed and the therapy must be more oriented to overall individual growth and development31. There is a need to push the cerebral palsy population to be exercised with proprioceptive stimulation for their maximum participation in the activities of daily life including both personal and social aspects. The proprioceptive training with a therapy regime enhances the body's somatosensory input that in result changes the body to be more functional in different types of interactions. This study is dedicated to finding out how much proprioception training is helpful in gross motor function level improvement and enhances functional activities of CP children.

Eligibility Criteria:
Inclusion Criteria:

* Children with the diagnosis of Cerebral Palsy (Spastic quadriplegia)
* Ages of 1 to 5 years
* Both males and females
* Alert and responsive to verbal and non-verbal commands
* Modified Ashworth Sale grade 1 to 2
* Gross Motor Function Classification System level 1V and V

Exclusion Criteria:

* Children under the botox treatment for tone management (botulinum injections)
* Diagnosed with any disease other than spastic quadriplegic cerebral palsy i.e. congenital heart defects, epilepsy, recurrent pneumonia, skin infections etc.
* Children underwent any surgery i.e. tenotomy (tendon release), recent heart surgery,
* Recent fracture and subluxation/dislocation due to fall or poor handling
* Any contracture or deformity on upper extremities, lower extremities and spine i.e. flexion contractures, club foot, scoliosis
Use of Rhythmic Auditory Cueing During Bilateral Training of the Upper Extremities in Stroke Patients

The purpose of the study is to determine the effect of rhythmic auditory cueing with bilateral arm training on upper limb functions in stroke patients.

Arm and hand movement problems are major contributors to disability in patients after stroke. In fact, only 5% of adults regain full arm function after stroke, and 20% regain no functional use. Hence, alternative strategies are needed to reduce the long-term disability and functional impairment from upper limb hemiparesis.

To solve problems concerning upper limb dysfunction related to stroke, various treatment methods have been used in several previous studies. Rhythmic auditory stimulation has been reported as an effective intervention for improving movement in the affected extremities of stroke patients.

To the best of our knowledge, no mentioned previous studies evaluating the effect of rhythmic auditory cueing with bilateral arm training using functional exercises on upper extremity impairment in patients with stroke in Egypt are reported. So, this study aims to determine the effect of rhythmic auditory cueing with bilateral arm training on upper limb functions in patients with stroke.

Eligibility Criteria:
Inclusion Criteria:

1. Thirty patients with ischemic stroke from both sexes will be included.
2. Patients will have stroke for the first time.
3. The age of patients will range from 45 to 60 years.
4. Duration of illness will be from six months to eighteen months.
5. The degree of spasticity will ranged from 1 to 1 + grade according to the modified Ashworth scale.
6. Patients will have moderate arm motor impairment (between 30 and 49 scores) according to Fugl-Meyer (FM) arm section scale.
7. The affected upper extremity will be the dominant side.
8. Patients will be able to sit and maintain balance in a sitting position.

Exclusion Criteria:

* The patients will be excluded if they have:

  1. Visual or auditory deficits.
  2. Perceptual disorders.
  3. Any surgical interventions in the upper extremities limiting the range of motion.
  4. Aphasia or apraxia.
  5. Musculoskeletal or neurological impairment of the unaffected upper extremity.
bpMedManage: Digital Technology to Support Adherence to Hypertension Medications

The purpose of the bpMedManage study is to rigorously test the efficacy of a smartphone technology to help improve high blood pressure medication adherence among older adults with mild cognitive impairment (MCI) in a 16-week randomized controlled trial. A total of 100 older adults will be recruited. There will be two treatment arms, bpMedManage-S and bpMedManage-P with 50 participants in each arm. Participants randomized into the bpMEDManage-S intervention arm will use a smartphone application with medication reminders plus receive education with standardized information on hypertension and antihypertensive medications on the education portal. Participants in the bpMedManage-P group will use a smartphone to receive education with standardized information on hypertension and antihypertensive medications on an education portal. Both groups will complete baseline assessments followed by 4 weeks of medication adherence monitoring. At the end of the adherence monitoring period, participants will be randomized into one of the two treatment arms. Immediate outcomes on primary and secondary measures will be assessed 4 weeks after beginning of the intervention. Follow-up outcomes will be assessed 12 weeks after the beginning of the intervention.


Eligibility Criteria:
Inclusion Criteria:

1. Age 60+
2. Community-dwelling older adults
3. Self-reported fluent in English
4. Adequate self-reported visual and hearing ability
5. Self-reported memory, thinking, or concentration challenges
6. Self-manage at least one prescribed antihypertensive medication
7. Have and use a smartphone
8. No self-reported history of major depression or other mental health diagnoses
9. No self-reported diagnosis of dementia or other neurological disorder such as stroke, TBI, and Parkinson's disease
10. TICS-M score between 27-37 and Montreal Cognitive Assessment (MoCA) score between 20-26
11. Willing to participate in the study for at least 4 months

Exclusion Criteria:

1. Diagnosis of dementia
2. Lives in assisted living facility or skilled nursing facility