cyrilzakka/clinical-trials huggingface dataset:
Effect of Aerobic Training in Moderate or Severe Asthmatic Patients

Exercise training has been proposed as adjunctive therapy in asthma to improve many clinical outcomes; however its effects on bronchial hyperresponsiveness (BHR) and inflammation, characteristic features in asthma, remains poorly understood. We aim to investigate the effects of aerobic training on BHR (primary aim) and systemic inflammation (secondary aim). In addition, clinical control and health related quality of life (HRQoL) will be also assessed.

This is a randomized, controlled and single-blind trial whose intervention will be an aerobic training. Fifty -eight patients with moderate or severe persistent asthma will be recruited at a university hospital and randomly assigned in two groups: control (CG) or training (TG) .The study will be performed between two medical visits with intervals of six months and during this period the same medication dosage will be maintained. Patients in CG will perform (an educational program + breathing exercise; n=28) and TG patients will perform (an educational program+breathing exercises+aerobic training; n=30).The sessions will be conducted twice a week, for 3 months. Before and after the intervention, all patients will be evaluated by bronchial hyperresponsiveness, serum cytokines levels, total immunoglobulin E, induced sputum, fractional exhaled nitric oxide (FeNO), asthma clinical control (daily symptoms dairy, exacerbations and asthma control questionnaire - ACQ), health related quality of life (HRQoL); asthma quality of life questionnaire-(AQLQ), pulmonary function and cardiopulmonary exercise testing. All the patients will be evaluated by specific immunoglobulin E (atopy) through (skin prick test or Phadiatop).

Eligibility Criteria:
Inclusion Criteria:

* Patients with moderate and severe persistent asthma
* Asthma will diagnosed according to Global Initiative for Asthma (GINA)
* Body Mass Index \<35 kg/ m2
* Patients will submitted the medical treatment, followed by pulmonary specialists for at least 6 months.

Patients will considered clinically stable (i.e., no exacerbation or changes in medication for at least 30 days).

Exclusion Criteria:

* Patients will diagnosed with cardiovascular, musculoskeletal or other chronic lung diseases;
* Patients with current participation in exercise programs
* current smokers or ex-smokers will excluded from the study.
Binocular Vision in Monocular Pseudophakia

Following cataract surgery, an intraocular lens (IOL) is implanted in the eye. The majority of people develop an operable cataract when they are over the age of 50. Occasionally people under 50 years develop a cataract requiring an operation. The visual demands in this age group are very different due to both physiological and lifestyle factors. Traditionally IOLs are focussed for distance vision and additional spectacles are worn for near vision. Under the age of 45 years we have the ability to naturally change the focus of our eyes and do not require additional reading glasses. This is known as accommodation. By removing the cataractous lens and replacing it with an IOL with a fixed single focus, both eyes work together for distance vision but only the unoperated eye is able to change focus for different working distances. This study aims to establish whether a multifocal IOL implanted in one eye is able to complement the accommodation in the other eye so the 2 eyes work more effectively together. This may enhance depth perception and improve the quality of vision. Depth perception is important for more comfortable vision on the computer screen, when reading and for jobs that require good depth perception.


Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Male or female, aged 18 - 45.
* Cataract operation required in one eye only, either due to the presence of cataract affecting visual function, or in combination with surgery which is likely to cause visually significant cataract.
* Expected visual improvement in operable eye of at least 6/12.
* Fellow eye with a VA of at least 6/9.
* Astigmatism of 1.0D or less.
* Target of emmetropia in the operated eye.
* Intact posterior capsule with planned implantation into the capsular bag.
* IOL power required 10 - 30D.

Exclusion Criteria:

* Pre-existing amblyopia or squint.
* Significant diabetic retinopathy.
* Macular off retinal detachment with metamorphopsia or poor visual prognosis.
* Other macula or ophthalmic pathology affecting macula function resulting in poor visual prognosis.
* Pregnancy, lactating or planned pregnancy during the study period.
Evaluation of Retinal Changes in Systemic Darbepoetin Alpha Treatment in Patients With Diabetes Mellitus

The purpose of this study is to determine whether systemic administration of darbepoetin alpha results in the progression or regression of diabetic macular edema.


Eligibility Criteria:
Inclusion Criteria:

Group A:

* Males and females aged 18 to 80 yrs
* Diabetes mellitus type 1 or 2
* Haemoglobin level above the treatment threshold level (as described in the drug description)
* Receiving no darbepoetin alfa treatment
* Best Corrected Visual Acuity (BCVA) better than 20/200
* No clinically significant macular edema (CSME) or CSME already treated with laser photocoagulation.

Group B:

* Males and females aged 18 to 80 yrs
* Diabetes mellitus type 1 or2
* Anaemia (due to renal failure), haemoglobin level under the treatment threshold level before the initialisation of the therapy (as described in the drug label)
* Starting to receive darbepoetin alfa treatment (darbepoetin alfa, Aranesp, Amgen)
* BCVA better than 20/200
* No clinically significant macular edema (CSME) or CSME already treated with laser photocoagulation.

Exclusion Criteria:

* History of retinal disease other than DR
* History of intraocular surgery, including laser treatment in the past 4 month
* A major change in the insulin treatment of the patient in the past 4 month or during the follow up period.
* Inability to communicate in German or English
* Dementia; inability to follow commands
* Epilepsy
Effect of Allopurinol or Febuxostat to Prevent Contrast Induced Acute Kidney Injury (CI-AKI)

A randomized, placebo-controlled, double-blind clinical trial of effect of allopurinol or febuxostat to prevent contrast induced acute kidney injury (CI-AKI)

Eligible patients (patients with glomerular filtration rate \< 60 ml/min or high riks patients based on Mehran score) that will be undergoing cardiac catheterization/intervention randomly assigned to receive allopurinol 300 mg or febuxostat 80 mg 12 hours before and 12 after 1 exposure of radiocontrast and IV hydration (normal saline 1 ml/kg/hr 12 pre and post radiocontrast exposure) or placebo and hydration.

Exclusion criteria: patients under treatment with allopurinol or febuxostat in the previous seven days, known allergy to allopurinol or febuxostat, patients on renal replacement therapy

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older who are scheduled to coronary intervention
* Patients with Mehran score \> 5 or modified Mehran score \>2 even glomerular filtration rate \> 60 ml/min (high risk patients)
* Glomerular Filtration Rate \< 60 ml/min
* All the patients provided written informed consent for the procedures and the test drug

Exclusion Criteria:

* Patients with shorter hospital stay (\<48 hours)
* Patients under treatment with allopurinol of febuxostat
* Patients on renal replacement therapy
* Known allergy to allopurinol or febuxostat
The REPLICCAR Registry and The Statewide Quality Improvement Initiative

Cardiovascular diseases remain the leading cause of death for the healthcare system and cardiac surgery has an important impact on their resolubility. Healthcare systems in the world have evolved to optimize their clinical records and thus learn from the real world through the interactivity between results, processes, and structure. When the rate of growth of healthcare costs scenario is greater than the one of Gross Domestic Product of countries, there is a considerable challenge to increment the quality of healthcare services and the primordial patient safety, as well as the necessary control and traceability of implantable devices. The association and correlation of patients' demographic and clinically relevant information with the resources required for the care provided for each stratum represent the possibility to adapt, improve and innovate the healthcare programs; This will allow improving the optimization of the therapeutic protocols and the creation of related research areas, aiming to promote more equitable resources allocation, increase access and effectiveness, as well as to ascertain the magnitude of available and used resources and its impact.

METHODS Extension Cohort study, mandatory, prospective multicenter, in the state of São Paulo and of registry of consecutive cases. Besides the situational diagnostic of the results and comparison between the mean of both registries, there will be the creation of improvement reports for each of the REPLICCAR centers.

Next, quality improvement initiatives will be implemented in each center indicated by the reports.

Sample

* Will be included in a consecutive way all patients that had CABG and heart valve surgery in the participant centers for the defined period;
* Data will be collected, independently of surgical volume, severity status, and social condition among others, in sight of the São Paulo state health department;
* This way, it will be possible to produce a predictive curve to be used in most clinical case scenarios observed in the state of São Paulo;

Eligibility Criteria:
Inclusion Criteria:

* Age 18- 90 years old.
* CABG or heart valve surgery
* Agreement to participate in the study signing informed consent documentation.

Exclusion Criteria:

* Re-operation
* Impossibility to access data variables relevant to the study.
Home-based Visual-motor Training Program on Kindergarteners

The study aims to investigate the feasibility and effectiveness of the traditional and computerized home-based visual-motor training programs on at-risk kindergarteners.

The purpose of this project is to investigate the feasibility and effectiveness of home-based traditional visual-motor activities and tablet games on fine motor, visual perception, visuo-motor integration, handwriting performance, and adaptive behaviors of at-risk kindergarteners. At-risk kindergarteners will be randomized into the three groups: control, traditional, and tablet groups. In addition to regular early intervention, children in the traditional and tablet group will receive home-based visuo-motor training program with their parents. Children in the control group will only receive regular intervention during the study period.

Eligibility Criteria:
Inclusion Criteria:

1. Either visual perception or fine motor score below the norm average
2. can follow instruction and complete the entire tests

Exclusion Criteria:

1. Visual or hearing problems that cannot be corrected to be normal
2. A diagnosis of significant neurological, muscular, and skeletal system disorders (e.g., Cerebral palsy)
3. A diagnosis of moderate or severe intellectual disabilities
4. Taking medication to control seizure or improve learning abilities
Internet-based Treatment for Informal Caregivers in Lithuania LINGI

The purpose of this study is to evaluate efficacy of internet intervention for informal caregivers in Lithuania in reducing their care-giving burden.

Intervention is going to take a form of an Internet based Cognitive Behavioural Treatment program (ICBT) consisting of eight modules. These are the themes, as listed chronologically: Introduction, Thoughts, Stress and relaxation, Problem Solving, Communication, Anxiety, Behavioural Activation, Maintenance. These themes were chosen after considering topics which might be the most useful for someone in a role of an informal caregiver, considering the trans-diagnostic nature of the intervention.

Effect of the intervention will be compared against a wait-list control group. Intervention is in Lithuanian.

Eligibility Criteria:
Inclusion Criteria:

* must be 18 years old or over
* fluent in comprehending, writing and reading Lithuanian language
* score 24 or more points on the Caregiver Burden Inventory
* spent at least last couple of months for providing care
* must have internet access and ability to use computer or any other compatible device

Exclusion Criteria:

* adverse life experiences as identified by LEC
* alcohol addiction
* having severe physical or mental impairments
* suicide risk
* severe interpersonal violence
* the person in need of care has life expectancy below or approximately around 6 months
GALIG Gene Expression in Parkinson's Disease

Parkinson's disease (PD) is the most frequent neurodegenerative disorder after Alzheimer's disease. It is characterized by motor symptoms (rigidity, tremor, slowness of movements), and non-motor symptoms (neuropsychological, psychiatric, pain ...). Neuronal death initiates in the brainstem and extends progressively through the entire cortex. The processes leading to cell death are poorly understood. Pathological cells exhibit abnormal deposits, called Lewy bodies, which contain numerous proteins. A major constituent of these protein deposits is alpha-synuclein. It has recently been demonstrated, in the Laboratory of Molecular Biophysics of the CNRS (Scientific Research National Center) in Orleans, that α-synuclein interacts with Cytogaligin, a protein produced by the proapoptotic GALIG gene. Cytogaligin could thus be a factor regulating α-synuclein activity or aggregation. It is postulated that the level of expression of the GALIG gene is different in Parkinson's disease patients compared with control subjects.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Parkinson's Disease according to the criteria of the UKPDBB (UK Parkinson's disease brain bank).

Exclusion Criteria:

* Insane patient arriving without a third party.
* Patient with Parkinson's disease arising from another etiology.
Effects of Training Based on the Pilates Method on the Blood Pressure of Hypertensive Women

The main objective of this study is to evaluate and compare the effect of the Pilates method associated with aerobic exercise and the traditional Pilates method on the blood pressure of hypertensive medicated women. In addition, we aim to analyze and compare the chronic effects of training on cardiac autonomic modulation, on cardiorespiratory fitness, functionality and quality of life.

Subjects will be allocated randomly in three groups: (1) Traditional Pilates group, which will perform only exercises based on the traditional Pilates method, (2) Modified Pilates group, which will perform exercises based on the Pilates method alternated with active rest periods on treadmill ergometer, (3) Control group: will not perform any physical exercise during the trial period. The sessions will be performed two times a week, during 16 weeks. Subjects will be evaluated before and after 16 weeks of intervention.

Eligibility Criteria:
Inclusion Criteria:

* Hypertensive women
* Age 30 to 59
* Sedentary or who do not practice any form of physical exercise regularly for at least 6 months
* Make use of antihypertensive medication
* Who have medical clearance for physical exercise

Exclusion Criteria:

* Complaint of pain that influences or makes the performance of the tests / exercises proposed impossible
* Congenital or acquired anomalies of upper limbs and lower limbs
* Presence of musculoskeletal disease or injury that interfere the performance of exercises
* Changes in pharmacological treatment during the experimental period
* Release for physical activity suspended during intervention
* Absence in more than 25% of the exercise sessions
Feasibility of Using the CGM During TOC From in Persons With T2D Using Insulin

Using the Libre during the TOC with persons with T2D will improve patient glucose monitoring and satisfaction, which can potentially lead to an improvement in glycemic control and hospital utilization. This study aims to assess this with inpatients using insulin.

Integrating the use of the Libre during the TOC will improve patient glucose monitoring and satisfaction, which can potentially lead to an improvement in glycemic control and hospital utilization. Inpatients admitted to the medical-surgical units would be considered based on the inclusion and exclusion criteria. If the patient qualifies they would be consented to participate in the trial. In addition they would be given a script for refills. Primary outcome is change in HbA1c and secondary outcomes at baseline and 90 days include satisfaction, number of ED/inpatient visits, completion of follow-up appointment, and duration of CGM use.

Eligibility Criteria:
Inclusion Criteria:

* Persons with T2DM
* Persons on atleast 3 injections of insulin/day
* Persons whose insurance will cover the device

Exclusion Criteria:

* Persons with adhesive allergy
* Pregnant women
* Persons with CKD 4/5 or on dialysis
Effects of Active Stretching on Cardiovascular Response and Arterial Stiffness in Older Adults With Low Flexibility

A study of the effects of active static stretching exercise in elderly people with poor lower extremity muscle flexibility on autonomic and cardiovascular responses and balance ability.

This study aims to investigate the effects of active static stretching exercises on autonomic nervous system responses, arterial stiffness, and balance ability in elderly individuals with poor flexibility in the lower extremity muscles.

Participants will engage in an 8-week exercise program consisting of active static stretching sessions, focusing on major muscle groups in the lower limbs. The intervention is designed to improve arterial elasticity and heart rate variability (HRV) while enhancing dynamic and static balance performance.

Outcomes will include measures of heart rate variability (HRV), arterial stiffness, and physical performance assessments such as the Timed Up and Go test (TUG), Single-Leg Stance test (SLST), and muscle strength tests. Body composition and flexibility (sit-and-reach test, back scratch test) will also be evaluated.

The study hypothesizes that active static stretching will promote improvements in autonomic regulation and cardiovascular health, as well as increase flexibility and balance control in community-dwelling older adults with reduced lower-limb flexibility.

Eligibility Criteria:
Inclusion Criteria:

* - Elderly males and females
* Have a normal body mass index (between 18.5-24.5 kg/m2)
* Be able to follow instructions and willing to participate in the study
* Be able to communicate with the researcher and provide information by themselves (the researcher will read the questions to the volunteers and let the volunteers choose the answers by themselves)
* Be able to walk continuously for at least 10 meters with or without walking aids
* Have low flexibility with a forward lean distance not exceeding the 40th percentile from the sit and reach test according to the American College of Sports Medicine criteria

Exclusion Criteria:

* - Abnormalities such as pain or inflammation of the legs more than 5 points, assessed by (visual analog scale (VAS) \> 5 points)
* Significantly different leg lengths (more than 1.4 centimeters) or abnormalities of joints, including abnormal sensations that affect movement and walking
* Uncontrolled chronic diseases or obstacles to study, such as high blood pressure, diabetes, asthma, neurological diseases such as Parkinson's disease, Alzheimer's disease, skeletal and muscular diseases such as chronic back pain, acute osteoarthritis, sprained ankle
* Vision problems that cannot be corrected by wearing glasses
* Uncorrected hearing Inner ear disturbances that affect balance, such as otitis media
Effect of Inspiratory Muscle Training on Physiological Function and Clinical Outcomes After Lung Transplant

The purpose of this research is to study the effect of training the inspiratory muscles (i.e. the muscle that allow you to breath-in) on exercise capacity, quality of life, and short-term clinical outcomes in patients post lung transplant.


Eligibility Criteria:
Inclusion Criteria:

- All patients who undergo single- or double-lung transplant at Mayo Clinic Florida.

Exclusion Criteria:

* Patients who do not survive the intra-operative period during the transplant surgery.
* Patients undergoing retransplantation.
* Patients undergoing multiorgan transplantation.
* Patients who are not willing to or who are unable to give written informed consent.
Preoperative Nutritional Assessment for Predicting Complications Risk in Patients Undergoing Abdominal Surgery

Predictive Value of Various Nutritional Screening and Assesment Tools and a Surgery Scoring System (POSSUM Score) for Predicting Postoperative Complications in Patients Scheduled for Abdominal Surgery.

Preoperative malnutrition in surgical patients is an established risk factor of peri-operative morbidity and mortality, post-operative complications, infections and increased length of hospital stay. The reported prevalence of malnutrition in gastrointestinal (GI) and major abdominal surgery patients ranges from 30% to 50%. For these reasons it is important to recognize malnourished patients before surgery in order to provide the most appropriate preoperative nutritional therapy which will in turn improve nutritional status and reduce postoperative complications and length of hospital stay.

The aim of the present study was to compare the prognostic power of different screening tools for post - op complications. This was a prospective observational cohort study, performed in patients scheduled for an abdominal operation in the Second Department of Surgery, Evangelismos General Hospital in Athens, Greece. All patients were screened at admission and before operation. Data were collected in a special form by the dietician and the surgeon, with the use of screening tools and the local Electronic Medical Record System called "Emrora". Patients were followed up after surgery until discharge by the surgeon who recorded any complication or case of death in a new form.

Eligibility Criteria:
Inclusion Criteria:

* 18 years at least
* Diseases of the digestive tract (oesophageal, gastric or intestinal), or other abdominal diseases requiring elective surgery,

Exclusion Criteria:

* Age \< 18
* Pregnancy
* Major coagulopathy
* Permanent pacemaker
* Specific preoperative nutritional support before admission to hospital
* Unable to give consent