cyrilzakka/clinical-trials huggingface dataset:
Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS

Among the many changes associated with the impact of HIV and the long-term use of antiretroviral therapy, metabolics are important because they are important risk factors for the development of cardiovascular diseases. The objective of the present study is to evaluate the effect of the supplementation of curcumin, on the oxidation of resting energetic substrates in HIV / AIDS patients. The sample will be composed of adults living with HIV / AIDS on antiretroviral therapy for at least 6 months. Supplements will be made separately for 30 days and will be evaluated before and after the intervention the following parameters: body composition, energy metabolism, biochemical parameters and a structured anamnesis. Food consumption and the level of physical activity of the volunteers will be controlled.

The study is characterized as a double-blind randomized clinical trial. Participants in the study will be adults living with HIV / AIDS who undergo regular clinical follow-up at some Specialized HIV / AIDS Care Service.

The sample will consist of 20 volunteers, 10 in the experimental group (GE) and 10 in the control group (CG). Participants will be randomly assigned to one of the groups by lottery by a researcher not participating in the study. The researcher responsible, as well as the volunteers, will not be aware of which participants are in the GE or the GC.

The study will be carried out in the Movement Laboratory of the Physical Education Department of the Federal University of Rio Grande do Norte.

Eligibility Criteria:
Inclusion Criteria:

* Antiretroviral therapy has been available for at least 6 months, aged 18 years or over.

Exclusion Criteria:

* Individuals with endocrine and pregnant disorders will be excluded.
Preoperative Radiotherapy for Sarcomas of the Extremities With Intensity-Modulation, Image-Guidance and Small Safety-margins

RATIONALE: Modern radiotherapy techniques in a neoadjuvant setting have the potential to minimize morbidity and maximize efficacy. An additional boost dose can be provided locally by HDR-brachytherapy in patients with positive margins after tumor resection.

PURPOSE: This phase II trial is studying the safety and efficacy of a combination of modern radiotherapy elements applied to the tumor and small volumes of surrounding normal tissue (IMRT, IGRT; brachytherapy in case of positive resection margin) and see how well it works in treating patients with High-Risk Soft Tissue Sarcoma of the Extremities.


Eligibility Criteria:
Inclusion Criteria:

Histologic and radiographic proof of localized high-risk soft tissue sarcoma meeting the following criteria:

* Lesion originates in extremity

  * upper extremity lesions may occur from the medial border of the scapula to tumors as far distal as the finger tips
  * lower extremity regions include hip girdle tumors commencing at the iliac crest, excluding lesions arising from within the pelvis, and extends to include lesions as far distal as the toes
* AJCC Stage II or III disease (except T1a-tumors or N1)
* Primary presentation or local recurrence
* after biopsy or inadequate surgery resulting in residual tumor in cross-sectional imaging
* Tumors must be considered resectable according to cross sectional imaging, or potentially resectable after preoperative radiotherapy
* ECOG Performance Status 0-2
* Informed Consent

Exclusion Criteria:

* Diagnosis of the following:

  * Primitive neuroectodermal tumor
  * Soft tissue Ewing's sarcoma
  * Extraskeletal osteo- or chondrosarcoma
  * Aggressive fibromatosis (desmoid tumors)
  * Dermatofibrosarcoma protuberans
* Regional nodal disease or unequivocal distant metastasis
* Life expectancy \< 1 year
* Pregnancy
* Major medical illness that would preclude study treatment
* History of major wound complication or recurrent skin infection
* Known HIV positivity
* \< 2 weeks elapsed from prior surgery or cytotoxic chemotherapy
* persisting acute toxicities \> grade 1 in tumor-bearing limb resulting from prior treatment with anti-cancer modalities
* Cytotoxic chemotherapy, targeted therapy or investigational agents concurrent to study treatment
* Prior radiotherapy to the site of present STS.
* Chronic requirement for treatment with immuno¬suppressive agents or steroids.
Prevalence of Irritable Bowel Syndrome in Medical Students Africa

The aim of the present study was to assess the prevalence of IBS among medical students in the Middle East and North Africa and to investigate the sociodemographic, lifestyle, and clinical factors associated with IBS. A better understanding of IBS correlates is expected to improve our therapeutic approach to IBS in this population.

Irritable bowel syndrome (IBS) is a multifactorial chronic disease characterized with functional gastrointestinal disorder which affects the quality of life of the patient. Until now the pathophysiology of IBS was not completely understood but it has been related to multiple mechanisms like: visceral hypersensitivity, Brain-gut axis, post infectious inflammation and genetic abnormalities.(1) Many demographic and environmental factors are considered risk factors for the condition like: sex, age, BMI, social status and life style(2). IBS outspreaded all over the world varying between 14.7% to 16.5% in east Asian countries(3,4). As IBS is diagnosed mainly clinically, many scales have been developed to provide the best sensitivity for diagnosing the condition. The recent common criteria for diagnosing are ROME III and ROME VI. A meta-analysis conducted by Oka et al the pooled prevalence of IBS in 53 surveys that used the Rome III criteria from 38 countries was 9.2% (95% CI 7.6-10.8; I2 = 99.7%). Contrary, the pooled IBS prevalence among the 6 surveys that used the Rome IV criteria from 34 countries was 3.8% (95% CI 3.1-4.5; I2 = 96.6%)(5). The different prevalence rates are probably justified by the multifactorial nature of the disease and the various social status and environments from a country to another. However, there wasn't enough studies could define the prevalence of IBS among middle-eastern countries. The prevalence of IBS varies depending on socioeconomic factors, sex, and age. University students in the Middle East and North Africa are affected by many Lifestyle factors that participate in IBS by one way or another such as unhealthy eating habits (junk or fast food), cigarette smoking, physical inactivity and the fact that they're living low-income countries. IBS has also been associated with psychological factors such as stress, depression, and anxiety. Additionally, as their young age genetic factors and positive family history are implicated. Medical students, are more likely exposed to IBS risk factors as they have limited access to healthy meals, financial constraints, and a excessive exposure to stress secondary to their exceedingly demanding education and frequent examinations. Thus, they are more probably to develop IBS than other population subgroups.

Eligibility Criteria:
Inclusion Criteria:

* Medical students enrolled in from medical schools located in the Middle East and North Africa.

Exclusion Criteria:

* 1- History of significant comorbidities 2- Participants with definite or suspected history of inflammatory bowel disease, celiac disease, Lactose intolerance or peptic ulcer disease. 3- Psychiatric patients or patients on antidepressant treatment or using psychotropic drugs affecting their cognitive ability.
Long Term Extension Study For SPM-005 Participants

This will be an open label multicenter study of the safety and efficacy of an active implantable vagal nerve stimulation (VNS) device in patients with rheumatoid arthritis. Patients who complete study SPM-005 will be enrolled in this study at the time of the last visit of the preceding study.

This will be an open label multicenter study of the safety and efficacy of an active implantable vagal nerve stimulation (VNS) device in patients with rheumatoid arthritis.

Patients who complete study SPM-005 will be enrolled in this study at the time of the last visit of the preceding study. The assessments at the last visit of the preceding study will also be used as baseline measures for the current study. If the patient has previously discontinued SPM-005 and greater than 30 days have elapsed since the final visit in SPM-005, baseline measures for the current study will be repeated, and an interim medical history will be taken to assess whether any new medical conditions were diagnosed in the time between studies.

Follow-up visits will occur at 3, 6, 12, 18, 24, 36 and 48 months. A final follow-up visit will occur for all remaining patients at study closure when the final enrolled subject has completed 48 months on study.

The study will continue until the last patient entered has completed 48 months in this study.

An Interim Visit or a phone contact must be performed a maximum of 2 months after any change in device settings. Interim visits may also be performed at any time at the investigator's discretion; either between scheduled visits, or after the patient has completed the Month 48 Visit, if the study is still ongoing.

The primary efficacy objective is to determine the long term efficacy of vagal nerve stimulation as assessed by the DAS28 score.

The secondary efficacy objectives are to determine the long term efficacy of vagal nerve stimulation as assessed by:

* the ACR 20, 50 and 70 response rate,
* the EULAR response rate, and
* changes in the Euro-QoL score.

The safety objectives are to determine the long term safely of vagal nerve stimulation as assessed by the subject incidence rates of:

* Adverse events
* Serious adverse events
* Device deficiencies

Eligibility Criteria:
Inclusion Criteria:

* Patients must have participated in study SPM-005

Exclusion Criteria:

* Inability to provide informed consent
* Significant psychiatric illness or substance abuse
Effect Aerobic Training on Women With Breast Cancer After Chemotherapy

Introduction: The purpose of this study was to determine the effect of twelve weeks of aerobic exercise program on erythrocyte levels in women with breast cancer after chemotherapy.

Methods: Thirty women with breast cancer after chemotherapy of Sydalshhda hospital (aged between 47-65 years) volunteered for this study, and then randomly selected an exercise (n = 15) and control (n = 15) groups. Exercise group completed a twelve-week aerobic exercise training program consisted of three sessions per week, each session lasting 30 to 60 minutes 50 to 75 percent of their maximum heart rate reserve, while the control group were followed. Blood samples including red blood cell counts (RBC), hematocrit (HCT), hemoglobin (HB), peak oxygen consumption before and after 12 weeks of aerobic exercise were measured. For analysis of data, repeated-measures analysis of variance (ANOVA) was used.


Eligibility Criteria:
Inclusion Criteria:

women with breast cancer , who can do a physical, physiological and psychological test; and did not have exercise limitations due to neuromuscular and/or musculoskeletal disease; did not have any health problems that prevented maximum effort on the treadmill test.

Exclusion Criteria:

women under erythropoietin treatments, uncontrolled cardiovascular or pulmonary diseases, uncontrolled arrhythmias, orthopedic conditions that would limit exercise participation, refusal for randomization, or participation in aerobic exercise training within 3 months before beginning the study.
Impact of Graduating to Resilience on Child Development in Uganda

This study is an intervention trial that aims to estimate the impact of the Graduating to Resilience (G2R) program on child development in Uganda. In previous trials, the G2R program has generated large, positive impacts on household assets, consumption, income and food security. The investigators will revisit a sample of households enrolled in a G2R trial conducted in Uganda in 2019-2021 (AEARCTR-0004080) and assess children born during the intervention period.


Eligibility Criteria:
Inclusion Criteria:

* Child born between April 2019 and June 2020
* Household enrolled in G2R intervention trial

Exclusion Criteria:

* None
Do Superfast Broadband and Tailored Interventions Improve Use of E-health and Reduce Health Related Travel?

Lack of internet infrastructure, personal skills, and service provision have been identified as potential barriers to e-health but as yet there is no good evidence of the impact of interventions to improve them. This study aims to assess impact on e-health uptake of three interventions (i) superfast broadband, (ii) a tailored leaflet to help participants improve personal internet skills and support, (iii) GP interventions to improve health service provision of e-health. In a cluster randomised factorial controlled trial, 1388 households from 78 postcodes were randomly selected from the 20088 Cornish postcodes and allocated to the 8 (2X2X2) arms of the study. Comparison of 'e-health readiness' and 'miles travelled' from baseline to 18 month follow-up between the 8 arms of the study, will be used to assess the effects of interventions, singly and in combination.


Eligibility Criteria:
Inclusion Criteria:

* 16+ and member of randomly selected household within Cornwall

Exclusion Criteria:

* Non Cornish households
Apathy Associated With Alzheimer's Disease

Apathy, or lack of motivation, affects up to 80% of Alzheimer's disease (AD) patients. These amotivational symptoms increase patient reliance on caregivers, increase caregiver burden and distress, and increase the risk of patient institutionalization. Only 50% of patients with apathy respond to current treatment with cholinesterase inhibitors. The mechanism of apathy in AD is unknown hampering rational treatment. Our proposed pilot study will provide initial data required to develop an amphetamine challenge paradigm to probe the brain reward system. These results will be used to develop a larger study evaluating the role of the brain reward system in apathy in AD and link this information with pharmacologic treatment. AD is a complex neurobiological illness that needs to be understood at several levels to optimize treatment. At a neurochemical level, one has to identify the neurotransmitter abnormalities that accompany the clinical symptoms. The neurochemical level of analysis provides the link between pathology and symptoms and, for now, is the only avenue for biological therapies. Next, one has to translate knowledge of neurochemical abnormalities to practical treatments for the symptoms of AD. This pilot will allow us to develop a study that can address both of these goals. Furthermore, the larger study will further define the emerging concept of apathy as a syndrome and has broader implications for apathy in many other neuropsychiatric diseases.


Eligibility Criteria:
Inclusion Criteria:

* age \> 55 years
* meet DSM-IV criteria for primary degenerative dementia
* meet NINCDS-ARDA criteria for probable Alzheimer's Disease of at least one year's duration
* mild to moderate cognitive impairment (Global Deterioration Scale GDS \<6, Mini-Mental State Examination \>10
* on a stable dose of a cholinesterase inhibitor for at least 3 months
* apathetic group only: Neuropsychiatric Inventory (NPI) Apathy subscale score \>=2

Exclusion Criteria:

* abnormal biochemical screening: blood cell count, vitamin B12, thyroid function tests, and syphilis screening tests
* significant medical illness or other medical/neurological conditions which diminish cognitive function
* evidence of seizure disorder
* an Hachinski ischemic score \>3 indicating vascular dementia
* a brain computed tomographic (CT) scan revealing focal lesions, or inconsistent with AD
* electrocardiographic, laboratory or physical evidence of significant cardiovascular disease
* presence of premorbid or current psychiatric diagnosis including: major depression, schizophrenia, psychotic symptoms of a severity likely to provoke violent or dangerous behaviour (i.e., command hallucinations to harm people or persecutory delusions that provoke violent reactions)
* current or past psychoactive substance abuse or dependence (including alcohol, excluding nicotine)
* contraindications to receiving dextroamphetamine or methylphenidate
* have had administration of a depot neuroleptic injection within one treatment cycle of the first visit
Safety and Efficacy of SQIN™ on Xerosis in Adults With Mobility Problems and Paralysis

In the general population, xerosis is often caused by external factors such as seasonal changes. In that case, the best way to relieve dry skin is to use a standard moisturizer. However, for those suffering of mobility problems due to age or paralysis (e.g., spinal cord injury, multiple sclerosis, Parkinson's, etc), xerosis is often severe and chronic because of the multiple causes (endogenous rather than exogenous ones) underlying such mobility impairment-related skin problems. This study is a double-blind, randomized study with positive control (active comparator) to assess the safety and efficacy of SQIN with CanSATs (Co-Activation of Natural Synergistically Acting Target-receptorS) technology on dry skin in patients suffering of paralysis.

Xerosis is a medical term for dry skin. When it results in skin that is scaly and itchy, the condition is called pruritus. This occurs when natural moisture is drawn out of the skin. The skin needs moisture to protect itself. The best way to relieve dry skin normally, for those suffering of seasonal dry skin problems, is to use standard moisturizers. However, for those suffering of mobility problems due to age or paralysis (spinal cord injury, multiple sclerosis, Parkinson's, Alzheimer's, muscular dystrophy, amputation, cerebral palsy, or other comparable disorders), xerosis becomes severe and chronic because of the multiple causes (endogenous metabolic problems and dysfunctions rather than exogenous ones). SQIN with CanSATs technology is designed to act upon multiple mechanisms for enhanced protecting, moisturizing, and repairing effects. Based upon preliminary evidence, SQIN with CanSATs technology can thus elicit significantly superior effects compared with standard, commercially available moisturizers.

Eligibility Criteria:
Inclusion Criteria:

* Paralyzed due to a spinal cord injury (traumatic or non-traumatic origin)
* Chronically injured (at least 3 months post-injury)
* Paraplegic or tetraplegic
* 18-75 years of age
* Men and women
* French-speaking

Exclusion Criteria:

* Acute or subacute stage (within 1 day and 3 months post-injury)
* Had tumor(s) (malignant or non-malignant) of the skin in the last five (5) years
* Allergic or hypersensitive to any ingredient, investigational or control product
* With psychiatric or mental disorder(s)
* Children (younger than 18 year-old) or elderly (older than 75 year-old)
* Not French-speaking
Continuous Regional Analysis Device for Neonate Lung

The purpose of the study is to assess whether Electrical Impedance Tomography (EIT) has the potential to optimize the ventilator therapy, validate the effectiveness, efficacy and safety of nursing and medical interventions (endotracheal suctioning, posture changes, surfactant therapy, recruitment manoeuvres, etc.) and for early recognition of complications like pneumothorax and endotracheal tube misplacement. The study design is purely observational.

EIT data will be recorded during 72 hours of routine clinical treatment. To prevent any decisions based on EIT information, the clinicians will be blinded to the EIT findings during the study period. Data on clinical interventions and clinical findings will be recorded using a specially adapted graphical user interface on the EIT device in combination with a paper-based case report form (CRF). EIT data analysis will be performed off-line.

Eligibility Criteria:
Inclusion Criteria:

* Written, informed consent of both parents or legal representative
* Admission in the NICU or PICU
* Patients with or at high risk of developing respiratory failure needing respiratory support.

  o i.e. (oxygen need (FiO2\>25%) AND noninvasive or invasive respiratory support) AND/OR repeated apnea with desaturations
* Age from birth to 7 years o Initial focus will be on neonates up to 6 kg and 12 months age. Infants of higher weight up to 7 years age will be included as EIT belts for this age group become available.

Exclusion Criteria:

* Post menstrual age less than 25 weeks
* Body weight \< 600 g
* Electrically active implants
* Thorax skin lesions
* Prior participation for the same diagnosis of lung disease
A Pragmatic Feasibility Trial to Promote Student Perspective-Taking on Client Physical Activity: A Collaborative Project

This mixed-methods parallel two-arm trial assessed the feasibility, appropriateness, and acceptability of a theoretically-informed intervention designed to improve perspective-taking skills in preparation for a future definitive randomized control trial. Using a 1:1 allocation ratio, student participants (N = 163) in Respiratory, Physical, and Occupational Therapy; Nurse Practitioner; and Kinesiology programs at a Canadian university were randomly assigned to full or partial intervention conditions. Full intervention participants completed an online workshop on perspective-taking and practiced perspective-taking prior to an in-lab 10-minute dialogue with a trained client-actor (masked to condition) about the actor's physical inactivity. Partial intervention participants received the workshop after the dialogue, and were instructed to be aware and mindful of the approach that they took to seek understanding. To be considered feasible, outcomes needed to meet or surpass our criteria (e.g., within-course recruitment: 85-95% of a course when embedded within a course, 5-10% when not embedded). Feasibility and appropriateness were assessed by comparing recruitment rates, protocol, and psychometric outcomes to criteria. Acceptability was assessed by analyzing exit interviews. Recruitment rates, protocol, and psychometric outcomes largely met criteria, and the study was acceptable.


Eligibility Criteria:
Inclusion Criteria:

* Must be a student at the University of Manitoba
* Must have completed course content on behaviour change communication

Exclusion Criteria:

* Full intervention participants were excluded from descriptive statistics calculations if they partially completed the workshop or did not complete all phases due to client-actor availability
* Data from participating in additional study sessions were excluded