cyrilzakka/clinical-trials huggingface dataset:
Healthy Eating and Active Living for Diabetes: Glycemic Index

The main purpose of this study is to examine the effectiveness of enhanced GI-targeted nutrition education on dietary behaviour and intakes among adults with type 2 diabetes. Sixty-six eligible participants will be randomized into two equal groups using a pragmatic randomized controlled trial design.

This study proposes to examine the effectiveness of enhanced GI-targeted nutrition education on dietary behaviour and intakes among adults with type 2 diabetes.

Adults with type 2 diabetes will take part in this study and will be randomly assigned to either the HEALD-GI program (intervention) or in usual care (control). To evaluate the effectiveness of the program, 66 eligible participants drawn from the Alberta's Caring for Diabetes Cohort will be randomized into two equal groups using a pragmatic randomized controlled trial design. The control will receive only standard printed copies of Canada Food Guide and Canadian Diabetes Association (CDA) GI resources. The intervention group will receive additional GI concept information including GI values of foods, low GI recipes, menus, and application through websites with chat rooms, online videos, and print materials. These will be reinforced through email, text messaging/phone calls, and postal mail. GI knowledge and skill, self-efficacy, dietary intakes (using 3-day food record), anthropometry (body mass), and clinical measures (glycated hemoglobin A1c, systolic blood pressure), will be assessed at baseline and three months post-intervention.

The primary outcome will be change in GI related dietary behaviour and intake measured using 3-day food records (baseline and 3 months). Secondary outcomes include: 1) body mass, 2) glycemic control (hemoglobin A1c), 3) systolic blood pressure.

Significance:

Sufficient evidence is needed regarding the best approach for increasing uptake of current Canadian Diabetes Association (CDA) evidence-based recommendation to include low GI foods in daily meal planning as an effective dietary self-care practice for glycemic control among people with type 2 diabetes. Findings from this study will help determine if, and how, the current approach to disseminating the CDA dietary recommendations pertaining to GI concept could be improved for better uptake using the most efficient and cost effective patient-centered approaches to nutrition self-management. Besides, evidence generated will contribute to addressing some of the controversies regarding the clinical usefulness of the GI concept.

Eligibility Criteria:
Inclusion Criteria:

* Individuals 18 years of age or older; identified as having T2DM and currently enrolled in the Alberta's Caring for Diabetes cohort study
* Able to read, understand, and converse in English
* Willing to provide informed consent and currently living in Edmonton.

Exclusion Criteria:

* Those taking exogenous insulin and having physiological and /or medical conditions that interfere with normal digestive functions.
Effects of Modified Otago Versus Action Observation on Strength, Mobility and Fall Risk in Diabetic Neuropathy

To compare the Effects of Modified Otago Exercise and Action Observation Training on strength, functional mobility and fall risk in patients with diabetic neuropathy.

This study will be a randomized clinical trial. A total of 38 participants with diabetic neuropathy will be taken. By using non probability convenience sampling technique patients will be randomized and allocated into two intervention groups based on inclusion and exclusion criteria.Patients in group A will receive modified Otago exercises with conventional treatment.Patients in group B will receive Action Observation Training with conventional treatment.All participants will receive treatment of 40 minutes per session for 5 days a week for 8 weeks.The Michigan neuropathy screening instrument will be used for the assessment of diabetic neuropathy score.The strength,functional mobility and fall risk will be assessed by using 30 second chair stand test, Timed up and go test and fall efficacy scale.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with type 2 diabetes already diagnosed by physician from last 2 years
* Able to take instructions

Exclusion Criteria:

* Additional neurological problem Guillain barre syndrome, Parkinson disease, multiple sclerosis, other than neuropathy
* Participant with visual, vestibular system and auditory problems
* Participant with cardiovascular problem, cerebrovascular problem and epilepsy
New Approach for Treatment of Behavioral Disorders in Alzheimer's Disease (Alzheimer's Behavioral and Cognitive Disorders)

Alzheimer's disease (AD) is the most frequent form of dementia, causing high level of disability with elevated social costs. Alternative solutions to the standard pharmacological therapies have been studied in order to reduce the use of medications that frequently generates side effects and worsen patients' quality of life. A recent alternative treatment for AD is the Environmental Ecological Therapy (EET) that, with the use of therapeutic gardens, seems to reduce behavioral disorders (BD). However, the effectiveness of this approach is still mater of debate. Therefore, the aim of this trial will be to analyze the effects of EET, in people with severe AD.

Since Homo sapiens evolved in a natural environment, an intrinsic physiologic and psychological positive reaction to nature has been developed. Accordingly, emerging literature highlights the positive effect of therapeutic gardens, as environmental ecological therapy (EET) on the reduction of behavioral disorders (BD) and the preservation of cognitive functions in patients with Alzheimer's disease (AD).

Despite these promising preliminary studies, limited data are available on the effectiveness of EET in individuals with advanced AD. Therefore, the aim of the current trial will be to evaluate the effectiveness of EET on AD symptoms in patients with advanced AD.

Participants with advanced AD will be selected from among residents of the Alzheimer's care units of the Mons. Mazzali Foundation (Mantua, Italy). Selected participants will be randomly assigned to a treatment group (TR), or to a control group (CTRL).

Participants assigned to TR group will perform a program of EET for 2 hours a day, 5 days a week for a total of 6 months. Individuals assigned to the CTRL group will be treated with a standard therapy.

Eligibility Criteria:
Inclusion Criteria:

* Person with Alzheimer's disease.

Exclusion Criteria:

* Bedridden patients.
LPD+α-ketoacids on Autophagy and Improving Muscle Wasting in CKD

To investigate the effects of different dietary regimens on muscle wasting, insulin/IGF-1 resistance. Further, to explore whether LPD+KA decrease the activation of autophagy associate with insulin/IGF-1 pathway.

1. Dietary assessment: The composition of the diet will be evaluated through questionnaire, and analyzed a computer-based nutritional evaluation with Dieta software.
2. Biochemical data: blood samples will be collected at baseline and every 3 months of routine examination, such as blood routine, biochemistry, HbA1c, Serum IGF-1, CRP, will be measured. Homeostatic model assessment score (HOMA-IR) was recorded.
3. Skeletal muscle assessment: the parameters of skeletal muscle will be assessed before and after dietary intervention for 12 months. Body weight, height, Body mass index, skeletal muscle mass will be measured by Body composition analyzer. Quadriceps strength will be assessed with a seated leg press exercise instrument (Keiser Sport, Fresno, CA, USA) using the five repetition maximum technique. Knee and hip extension power (rate of generating force) will be assessed with a validated leg power instrument (University ofNottingham Medical College, Nottingham, UK). Fatigability will be assessed with the same bilateral leg press exercise used in strength testing.

Eligibility Criteria:
Inclusion Criteria:

* patients agree to participate in this study; age≥18 years and\<70years; renal function measured with creatinine clearance\<60 and \>15 ml/min (three monthly consecutive measurements)；at least 6 months of follow up at our clinic before recruitment and haven't received any diet intervention.

Exclusion Criteria:

* pregnant patients; diabetes; heart or liver failure; a recent myocardial infarction (in the last 12 months); long term immobilization; chronic respiratory failure; cancer; any pharmacological treatment that could modify muscle structure or function such as glucocorticoids or insulin；Contraindications of Ketosteril, such as hypersensitivity to the active substances or to any of the excipients, hypercalcaemia, disturbed amino acid metabolism to the study protocol.
Validity and Reliability of the Turkish Version of the Pectus Carinatum Body Image Quality of Life Questionnaire for Patients With Pectus Carinatum

In children with severe pectus carinatum, a significant loss of self-esteem, impairment in social behavior due to a decrease in quality of life associated with physical appearance and mental health has been reported. However, a questionnaire measuring these problems specific to this disease is not available in Turkish. Therefore, in our study, we aimed to investigate the validity and reliability of the Pectus Carinatum Body Image Quality of Life Questionnaire (PeCBI-QOL) in patients with Pectus Carinatum.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who have been diagnosed with Pectus Carinatum by a doctor (2 cm above the protrusion level)
2. Between the ages of 10-18,
3. Having dissatisfaction with this defect

Exclusion Criteria:

1. Having severe scoliosis (Cobb angle over 20 degrees)
2. Having chronic systemic disease
3. Having a serious psychiatric illness
4. Having complex mixed type pectus deformity
Brass Mesh Bolus in Rotational Post-Mastectomy Radiation Therapy

The hypothesis is that the daily use of brass mesh bolus achieves a comparable dose to every-other-day use of Superflab bolus (current standard of care) in chest wall post-mastectomy patients treated with rotational 6 MV photon delivery.

Intervention: During a standard-of-care 15 fraction radiotherapy treatment, a brass mesh bolus will be used for a single fraction. Small in-vivo dosimeters will be used for three treatment fractions to measure and compare skin doses for quantification purposes.

Comparator: Superflab and no bolus applied as per the treating physician's practice, typically on alternate days. The intervention and comparator tools are to be utilized on each participant.

Primary outcome

1. To determine the skin dose under brass mesh bolus and compare it with the skin dose under Superflab bolus (current standard of care).
2. To determine the number of fractions for which brass mesh bolus should be used to achieve an acceptable skin dose.

Eligibility Criteria:
Inclusion Criteria:

Women undergoing rotational chest wall radiotherapy following mastectomy for breast cancer treatment who would utilize Superflab bolus on some, but not all, days of radiotherapy treatment.

Exclusion Criteria:

Patients who require daily bolus due to skin involvement or other high-risk features requiring a high skin dose will not be included.
Open Label of Thalidomide in Treatment of Women With Chronic Pelvic Pain Associated With Endometriosis

Patients will undergo a standard history and physical examination detailing objective clinical exam findings performed by one of the co-investigators. The research coordinator will obtain baseline values for intensity of pain, quality of life, and coping strategies. Baseline serum levels inflammatory markers will then be measured. Over the course of 12 weeks Thalidomide will be titrated as tolerated to achieve a minimum of a 30% reduction of pain on VAS from week 2.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years
2. Histologically/laparoscopically confirmed endometriosis
3. Chronic pelvic pain defined as non-menstrual pain for at least two weeks in the previous month for at least 6 months
4. VAS of 6 or more at baseline
5. Failure, completion or intolerance of standard treatment modalities (oral contraceptive therapy, danazol, Depo-Provera, Depo-Lupron)
6. Patients must give written informed consent.
7. Patients must be willing and able to comply with the FDA-mandated S.T.E.P.S.® program.

Exclusion Criteria:

1. Pregnant and/or lactating female
2. Users of other angiogenesis inhibitors
3. Current use of Rifampin, rifabutin, barbiturates, glucocorticoids, phenytoin, carbamazepine, chlorpromazine, reserpine, penicillin derivatives, or St. Johns Wart in user of oral contraceptive therapy
4. Use of aromatase inhibitors, Etanercept (Enbrel), GnRH agonists (Depo-Lupron), and Danazol within the past 3 months
5. Use of norethindrone acetate (Aygestin) in the prior month
6. Seizure disorder
7. Hepatitis, or any active infection (upper respiratory infection, PID, etc)
8. History of thromboembolic disease.
9. Baseline neutropenia (ANC \< 1000/mm\^3)
10. Any severe physical or metal illness that would interfere with the completion of the protocol
11. Illicit drug or alcohol abuse
Effects of Paired Associative Nerve Stimulation on Spinal Cord Injury Subjects

This study is to investigate the effects of repetitive transcranial magnetic stimulation (rTMS) combined with trans-spinal electrical stimulation (tsES) intervention on cortical excitability, brain structure, motor ability of lower limb in individuals with incomplete spinal cord injury. Twelve participants will be recruited in this study.

Spinal cord injury (SCI) impairs motor and sensory function and affects numerous body functions and daily activities. Insufficient central nervous system plasticity can result in maladaptive changes that prevent full recovery. It's a challenge to guide this plasticity to optimize the functional outcome for individuals with SCI.

Transcranial magnetic stimulation (TMS) and trans-spinal electric stimulation (tsES) may modulate cortical excitability, corticospinal output and spinal circuit. However, few studies investigated the effectiveness of paired nerve stimulation (PNS) on neuroplasticity and functional outcome in persons with SCI. Therefore, this study aim to examine the effects of the combination of these two different non-invasive nerve stimulation with the cycling exercise on the motor cortex and corticospinal circuit excitability as well as functional recovery.

Present study clarifies the effects of five different settings of combined with TMS and tsES intervention and then undergo cycling exercise after PNS on spinal cord and cortical excitability in SCI participants.

It is expected that this project will successfully establish a new neuromodulation technology to enhance cortical, corticospinal and spinal circuit excitability as well as to improve the outcome of lower-limb function and quality of life in persons with SCI. Therefore, this project can not only publish scientific papers, but also can enhance the neuroplasticity and improve function in persons with SCI.

Eligibility Criteria:
Inclusion Criteria:

1. Age 20 to 65 years incomplete SCI (American Spinal Injury Association Impairment Scale (ASIA) B to D)
2. Lesion area above the tenth thoracic vertebra (T10)
3. Injury time more than one year
4. Without range of motion (ROM) limitation
5. Medical condition stable

Exclusion Criteria:

1. Having pacemaker, cochlear implants, metal in the brain or skull, open wound of brain, or history of epilepsy.
2. Having seizure history
3. Having other neurological, mental, medical problems affect this study
Total Knee Arthroplasty Functional Outcomes Study Research Design

The purpose of this study is to obtain patient oriented and clinically oriented physical function outcomes both pre-operatively and post-operatively in patients receiving a total knee arthroplasty.

This study aims to use up to 75 patients at 3 centers to determine a baseline short-term post-operative physical function status of patients undergoing a total knee arthroplasty through patient and clinically based assessments. The KOOS score will collect data on the patient's physical function, stiffness and pain. The BERG balance, TUG, and TUDS tests will be used quantitatively to assess the patient's ability to conduct activities of daily living like walking for an extended period of time, standing from a seated position, and maintaining balance while performing a series of actions.

Eligibility Criteria:
Inclusion Criteria:

* Patient is male or non-pregnant female age 18 years or older at time of study
* Patient is a candidate for a total knee arthroplasty
* Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation

Exclusion Criteria:

* Patients with a primary diagnosis other than osteoarthritis of the knee as determined by an orthopedic surgeon
* Patients who have had any previous lower extremity procedure
* Patients with a BMI greater than or equal to 40
* Patients with an active infection within the affected knee joint
* Patients with a neuromuscular or neurosensory deficiency that may limit the ability of the patient to evaluate the safety and efficacy of the device
* Patients diagnosed with systemic disease or metabolic disorder leading to progressive bone deterioration (e.g. Lupus Erythematosus, Paget's disease)
* Patients immunologically suppressed or receiving chronic steroids in excess of normal physiological requirements (e.g. greater than 30 days)
* Patients with a known sensitivity to device materials
* Non-English speaking patients
* Patient is a prisoner
EXTended pRotective Curtain Under Table to Reduce Operator RAdiation Dose in Percutaneous Coronary Procedures

Radiation dose to interventional cardiologists performing transradial percutaneous coronary procedures is higher compared to those performing transfemoral exams. The radiation dose seems particularly high at pelvic level. We prepared an home-made protective extension of the leaded curtain under table that should reduce the operator exposure during interventional coronary procedures. The aim of the study is to evaluate the procedural efficacy of the protective extension on the operator radiation dose at pelvic level

Interventional cardiologists are routinely exposed to x-rays during their activity increasing the risk of deterministic and stochastic effects. Consequently all the operators should be aware of the possible risks and they should apply all efforts to reduce the radiation dose according to the "As Low As Reasonably Achievable" (ALARA) principle. Moreover interventional cardiologists have to utilise adequate protection devices (lead apron, protective thyroid collar, lead glasses).

Operator performing transradial access procedures showed a significantly higher radiation exposure compared to those performing transfemoral interventions. So, transradial operators should use adjunctive protective shields (as leaded pelvic drapes placed on the patient abdomen) in order to reduce their radio-exposition.

During transradial access a particularly high radiation exposure is observed at operator pelvic level and the use of the protective adjunctive drapes placed on the patient abdomen is only partially effective to control this exposition.

Aim of our study was to evaluate the effect of a protective extension of the leaded curtain placed under the angiographic table in term of operator radiation exposure at pelvic level

Eligibility Criteria:
Inclusion Criteria:

all patient undergoing percutaneous coronary procedures through transradial access

Exclusion Criteria:

1. Interventions performed through a different vascular access
2. Procedures performed in patients with ST elevation acute myocardial infarction
3. Haemodynamic instability
4. Lack of written informed consent
5. Age \< 18 years old
6. Previous coronary artery by-pass
The Clinical Effect of Palliative Treatment on Patients With Terminal Cancer

This study proposed a multidisciplinary collaborative team combined with a palliative care model and proposed to establish a team composed of medical staff in various disciplines to make up for the defects of a conventional nursing team. This study applied the multidisciplinary collaboration team combined with a palliative care model to patients with terminal cancer to evaluate its clinical effect.


Eligibility Criteria:
Inclusion Criteria:

* Patients were diagnosed as terminal by imaging, pathology and clinical manifestations
* the expected length of stay was more than seven days
* patients with clear consciousness, good communication and understanding ability
* voluntary participation in this study and signing of informed consent
* the estimated survival period is more than three months

Exclusion Criteria:

* Patients with cognitive impairment and mental illness
* those who were seriously ill and could not cooperate with the completion
* patients with severe communication disorders
Heavy Lifting Strength Training in Head and Neck Cancer Survivors

The LIFTING trial will examine the feasibility and safety of a heavy lifting strength training (HLST) program in head and neck cancer survivors (HNCS) at least 1 years post surgical neck dissection. The trial will determine whether this training style is safe and feasible in HNCS. Physical and psychosocial changes will also be reported.

RATIONALE Despite improvements in treatments, HNCS still endure numerous acute and chronic side effects. Strength training has been shown to manage some of these side effects but most interventions have involved light-to-moderate resistance training programs. HLST may produce better outcomes but it is unknown if such a weight training program is feasible and safe for HNCS.

OBJECTIVE The primary aim of this proposed study is to examine the feasibility and safety of a HLST program in HNCS at least 1 year post-surgical neck dissection.

METHODS This single arm feasibility study will recruit 15-20 HNCS to complete the HLST program 2 times per week. The primary feasibility outcomes will include the eligibility rate (with reasons for ineligibility), recruitment rate (with reasons for refusal), 1 repetition maximum testing rate (with reasons for not completing the test), program adherence (including attendance, dose modifications, and progression), and follow-up assessment rate (with reasons for drop out). The primary efficacy outcome will be strength gains from baseline. Secondary efficacy outcomes will include physical functioning, quality of life, fear of cancer recurrence, pain, body composition, anxiety, fatigue, stress, shoulder mobility, self-esteem, sleep, and motivation to engage in a HLST program.

SIGNIFICANCE Weight training is an effective intervention in HNCS but the optimal weight training prescription is unknown. If heavy weight training is deemed safe and feasible in HNCS, it can be compared to light-to-moderate load weight training to determine if it is a better prescription for improving outcomes that are important to HNCS.

Eligibility Criteria:
Inclusion Criteria:

* previously diagnosed with any subtype and stage of head and neck cancer
* at least one year post surgical neck dissection for head and neck cancer and showing full shoulder range of motion or recovery of the spinal accessory nerve
* adults ages 18 and older
* no unmanaged medical conditions, alcohol, and drug abuse
* approved for a heavy lifting strength training program by the treating surgeon and a certified exercise physiologist
* ability to understand and communicate in English

Exclusion Criteria:

* having comorbidities or uncontrolled medical conditions that their referred clinicians indicate as inappropriate to participate in exercise