cyrilzakka/clinical-trials huggingface dataset:
Clinical Impact of a Digital Home-based Falls Prevention Program on Elderly People

This study is a single-center, prospective, non-blind, parallel-group, randomized controlled trial with an experimental and a control group with the aim of evaluating the clinical impact of a home-based falls prevention program using a new biofeedback system on community-dwellers older adults with fall risk in comparison with standard of care.

The experimental group will perform a 12-week exercise program at home, under remote monitoring from a clinical team, whereas the control group will benefit from standard medical care currently in place at the participating primary care facility.

The hypothesis is that the home-based falls prevention program will lead to a lower risk of falling than standard medical care.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged over 65 years old
2. Ability to walk at least 20 meters, unaided or with unilateral support
3. Ability to understand motor complex commands
4. Mini-Mental State Examination (MMSE) score \> 24 points
5. Functional independence for instrumental activities of daily living
6. Risk of recurrent falls, defined as 5xSST score \> 15,00 seconds

Exclusion Criteria:

1. Patients residing in nursing homes, daycare units or assisted-living facilities
2. Aphasia, dementia or psychiatric comorbidity, significantly interfering with communication or compliance with a home-based exercise program
3. Severe visual our hearing, interfering with communication or with compliance to a home-based exercise program
4. Cardiac, respiratory or other condition incompatible with at least 30 minutes of light to moderate physical activity
5. Osteoarticular conditions (e.g. severe osteoarthrosis), which prevent the patient from complying with a home-based exercise program
6. Patients with neurologic conditions (e.g. stroke, multiple sclerosis, Parkinson's disease)
7. Other medical complications, which prevent the patient from complying with a home-based exercise program
8. Illiteracy
PINTA - Prophylactic Incisional Negative Pressure Therapy for Major Amputations

Post-operative wound issues in abdominal surgery have a significant impact on patient outcomes. This study is taking place to investigate if Negative Pressure Wound Therapy (NPWT) dressings reduces Surgical Site Infections, post surgical complications and improves scar appearance compared to standard dressings.

Many factors influence the risk of wound complications. Notably, the presence of unreconstructed proximal occlusive arterial disease is a major influence on stump healing. Patient factors such as smoking, diabetes, obesity, malnutrition and chronic kidney disease are non-modifiable, particularly in the short-term setting. However, surgical factors may be altered in an effort to reduce the risk of wound complications.

One option amenable to alteration is what dressing is applied to the closed incision upon procedure completion. The type of dressing may influence factors such as bacterial access to the wound, the development of collections of blood or fluid in the wound or fluid oozing from the wound. Collectively, these wound factors increase the risk of wound infection. Therefore, dressings which reduce these factors have the potential to reduce wound breakdown, thereby reducing the burden for patients and healthcare systems.

The investigators propose to conduct a multicentre randomised controlled trial comparing prophylactic single-use negative pressure wound therapy with standard dressings in patients with a closed incision following major lower extremity amputation in terms of SSI incidence, wound healing complications and scar appearance, patient quality of life and financial impact on the patient and healthcare system.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older;
* Patients undergoing major lower extremity amputation, including below-knee amputation, through-knee amputation and above-knee amputation, for any indication;
* Patients with primary closure of the surgical incision using either interrupted or continuous sutures

Exclusion Criteria:

* Patients \<18 years;
* Women who are pregnant and/or breast-feeding;
* Patients with amputations performed without primary skin closure, including guillotine amputations, amputations deliberately left open for drainage purposes and amputations with soft tissues defects at the stump;
* Patients with amputations where skin glue is the only means of skin closure
* Patients with a clinically absent femoral pulse
24-hour Blood Pressure Measurements and Ischemic Conditioning

To determine if 24-hr ambulatory blood pressure monitoring effects endothelial function, we will measure flow-mediated dilation before and after the blood pressure monitoring (ischemia conditioning).

Reestablishing blood flow (reperfusion) to organs that had their blood supply restricted (ischemia) can cause damage to the vasculature via injury and tissue death resulting in endothelial dysfunction. This ischemia-reperfusion (blood flow occlusion and resupply) triggered injury can be reduced or prevented by preceding brief periods of ischemia called preconditioning. Properly-performed preconditioning can exert a powerful protection against a subsequent sustained period of ischemia in a variety of organs in the body including the heart, kidney, and skeletal muscle. Preconditioning protocol involves repeated brief inflation and deflation of a blood pressure cuff. In many of human cardiovascular research studies, it is common to measure endothelial function and ambulatory (24-hour) blood pressure. The ambulatory blood pressure device takes repeated blood pressure readings every 15-30 minutes during the daytime and 30-60 minutes at night. It is possible that repeated bouts of inflation/deflation of the blood pressure cuff could induce preconditioning effects and influence endothelial function. Therefore, in the proposed study we aim to address this hypothesis.

Eligibility Criteria:
Inclusion Criteria:

Adults aged between 30 to 60 years old.

Exclusion Criteria:

Exclusion from the study may be due to: i) pregnancy (by asking the subjects when the last time she had menstruation; we do have simple testing kits available if a subject is unsure about her status); ii) a recent illness, recent surgery, or any medical intervention in the 48 hours before any of the study days; iii) personal history of diabetes (fasting blood glucose \> 126 mg/dL), heart disease, or other cardiovascular problems.
The Catalonia Suicide Risk Code Epidemiology Study: an Epidemiological Study of Suicide Attempts in Catalonia, Spain

Suicide attempts (SA) constitute a major public health issue worldwide. Research suggests that 2.7% of adult people ever attempt suicide; among children and adolescents this is estimated to be 6.0%. SA are related to subsequent suicide which represents an annual loss of 34.6 million years of life worldwide. Suicide attempts are also related to persistent physical and mental health issues, psychiatric hospitalizations, impaired academic performance, unemployment, partner abuse victimization and perpetration, having children removed by social services, loneliness, relationship difficulties, impaired social functioning and low life satisfaction. Despite this considerable societal impact, there is a lack of epidemiological research focussing on providing suicide attempt surveillance in the population, to inform public health action aimed at reducing risk for suicide attempts in the population, and to provide data-driven support for suicide risk assessment across healthcare settings. To address this shortcoming, the investigators designed the Catalonia Suicide Risk Code Epidemiology study. Using centralized Electronic Healthcare Record data from the entire public healthcare system of Catalonia, Spain, the CSRC-Epi study aims to estimate reliable suicide incidence rates, identify suicide attempt risk factors, and develop validated suicide attempt risk prediction tools.


Eligibility Criteria:
Inclusion Criteria:

* Catalan residency during 2014-2019
* age 10 or more at end of observation period

Exclusion Criteria:

* none
Association Between Plasma Melatonin and No-reflow

ST-segment elevation myocardial infarction (STEMI) is an acute manifestation of coronary heart disease, remaining a frequent cause of death. A better understanding of risk factors and pathogenic mechanisms underlying STEMI may help improve the prognosis and life quality of these patients. Melatonin is the chief indoleamine produced by the pineal gland, and a well-known antioxidant and free radical scavenger. Basic studies have showed that melatonin is associated with myocardial infarction and heart failure. However, no study has evaluated whether melatonin is associated with adverse clinical outcomes in STEMI patients.


Eligibility Criteria:
Inclusion Criteria:

a diagnosis of STEMI and needed PCI

Exclusion Criteria:

patients with cancer patients who used melatonin
The Dynamics of Human Atrial Fibrillation

The study is conducted in patients with atrial fibrillation undergoing clinically prescribed ablation. The study hypothesis is that ablation at specific sites that are identified to 'drive' the atrial fibrillation may improve the success of the ablation procedure.


Eligibility Criteria:
Inclusion Criteria:

* Subjects will be patients undergoing electrophysiology study and ablation for paroxysmal or persistent atrial fibrillation (AF) after having failed \>or= 1 anti-arrhythmic drug.
Usefulness of Transcutaneous Capnography to Assess Residual Hypoventilation in Obesity-Hypoventilation Syndrom Treated by Non Invasive Ventilation at Home : a Prospective Study

Transcutaneous capnography (PtcCo2) recently showed good agreement with blood gases to assess hypercapnia. There is no study that has evaluated the benefit to realise systematically a nocturnal PtcCo2 in the follow-up of home-ventilated patient with obesity hypoventilation syndrome (OHS). The investigators will evaluate the intake bring by nocturnal transcutaneous capnography, compared to nocturnal oximetry and blood gases, to diagnose nocturnal alveolar hypoventilation in a population of patient presenting an OHS, treated by non invasive ventilation (NIV) at home .

Patients will be evaluated once a year in consultation with a blood gases, and then a nocturnal recording at home including a transcutaneous capnography and an oximetry.

Some data will be registered too : cardiovascular and neurological comorbidities, diabetes mellitus, treatment, parameters of the non-invasive ventilation, duration of compliance and apnea-hypopnea index (if available).

The investigators will perform a sequential analysis of nocturnal hypoventilation with first blood gases, then nocturnal oxymetry and to finish nocturnal PtcCo2. It will allow us to determine if PtcCo2 catch up some nocturnal hypoventilation, undetected by the first two exams.

The investigators plan that the study will last 18 months. The analysis will be descriptive. Quantitative variables will be described with mean, standard deviation, minimum, maximum and median. Quantitative variables are presented with number and percentage.

Comparison of blood gas / oximetry association with blood gas / oximetry / transcutaneous capnography using a McNemar test

Eligibility Criteria:
Inclusion Criteria:

* Obesity Hypoventilation Syndrom defined by a diurnal PaCo2\> 45 mmHg, in stable conditions, in a patient presenting an obesity (BMI \> 30 kg/m²)
* treated by non invasive ventilation since at least 3 weeks, and seen in follow-up consultation

Exclusion Criteria:

* minors
* refusal to participate
* under guardianship or trusteeship
* pregnant woman
* other etiology of hypoventilation : copd, kyphoscoliosis, neuromuscular disorders, diaphragmatic pathology
Moderate Versus Deep Procedural Sedation With Propofol in the Emergency Department

This study is a clinical trial of moderate sedation versus deep sedation with propofol for procedural sedation in the Emergency Department. The purpose of this study is to compare the rate of amnesia and respiratory depression rate in patients who receive moderate sedation to those that receive deep sedation.

Purpose: For the pilot phase, if the visual memory assessment test developed in this study can adequately assess periods of amnesia during the procedure, then it can be used for the phase of the study that randomizes patients to moderate or deep sedation. The purpose of the randomized phase is to compare the rate of amnesia and respiratory depression in patients who receive moderate sedation to those that received deep sedation. The goal is to determine whether moderate sedation could provide a safer sedation while still resulting in adequate amnesia of the procedure. Secondary goals would be to compare the duration of sedation, the success of the procedures for which the patient is sedated, procedural difficulty, the rate of hypotension and other adverse events, and the patient perception of the quality of the sedation (pain or recall of procedure).

Background: Adequate pain control and alleviation of anxiety improves quality of care and patient satisfaction. Numerous studies have found that procedural sedation (PS) in the ED is safe, and when properly administered, the incidence of reported complications, including clinically significant respiratory depression, is rare. Procedural sedation is used for procedures such as fracture reduction, dislocation reduction, cardioversion, incision and drainage, and chest tube placement. Propofol is an anesthetic agent frequently used for PS in the Emergency Department (ED) and produces sedation, hypnosis, and amnesia, but lacks analgesic properties. In studies conducted at Hennepin County Medical Center (HCMC), we have found that patients are unable to recall whether or not they experienced pain during the procedure when sedated with propofol. However, there is the possibility that certain parts of the procedure can be later recalled by the patient. If extensive parts of the procedure can be recalled, then this is not an effective sedation. Previous studies of memory during sedation at HCMC have used verbal prompts only, but research has shown that people can more readily remember images. Images may provide a more sensitive way to determine the degree of amnesia during sedation.

Eligibility Criteria:
Inclusion Criteria:

* Adults undergoing procedural sedation with propofol in the emergency department

Exclusion Criteria:

* \< 18 years old
* Pregnant
* Previous allergic reaction to propofol
* Prisoner
* Unable to provide informed consent
Exploring the Experience of Communication for Patients With Depression

According to the statistics released by the Department of Health,Executive Yuan in 2005,depression, cancer and AIDS will become the three main diseases of the 21st century.The prevalence of depression is 5.8% for males and 9.5% for women in the worldwide total population each year.Depression ranks second next to cardiovascular disease and impacts on social and economic burdens.From the perspectives of prevalence,suicide rate,loss of workforce,family burden,co-morbidities and health care expenses,the issues related to caring for patients with depression should not be overlooked.Communication is often neglected while exploring the issues of caring for depressed patients,which can consequently affect their family,work performance,social interaction,and even leads to a risk of suicide.Therefore,in order to enhance their psychological adjustment and health management,it is particularly important to achieve effective communications.

This study aims to investigate the experiences of communication for patients with depression.Purposive sampling will be used to recruit participants in this study.Eligible participants consist of those who attend the outpatient department of psychiatry regularly,have emotional stability and clear consciousness,More than 20 years old,can be communicated in Mandarin or Taiwanese,and are willing to take the interviews.In-depth interviews will be conducted to collect qualitative data,and data will be categorized and analyzed according to Tesch(1990).Sampling will be stopped until data saturation.The findings may be referenced by the relevant agencies and medical institutions to care the patients with depression,as well as provide a basis for nursing care and education.

Eligibility Criteria:
Inclusion Criteria:

* Psychiatric physician-diagnosed patients with major depression,including major depressive disorder,identified patients with stable and stable condition treatment by a physician.
* Able to communicate to the language of the country or Taiwan.
* by explanations can share experiences,and has executed a written consent to.

Exclusion Criteria:

* Combined with other mental illness.
* Depression in patients with unstable condition,including serious and has a tendency to suicide,violence and attacks.
Lysyl Oxidase, Semaphorin 7a and Semaphorin 3a in Patients With Systemic Sclerosis

The aim of our study is to find a biomarker for fibrosis or vasculopathy in systemic sclerosis. We will evaluate a possible correlation between semaphorin 7a, semaphorin 3a and lysyl oxidase and fibrosis (lung and skin) or vasculopathy in patients with systemic sclerosis. The results obtained may help us diagnose these complications of systemic sclerosis and hopefully even monitor patient treatment.


Eligibility Criteria:
Inclusion Criteria:

* Systemic Sclerosis Patients
* Written consent to participation in study

Exclusion Criteria:

* Serious active medical condition
* Other autoimmune rheumatic disease
* Current or past allergic/inflammatory reaction
* Liver disease
* Pregnant or breastfeeding
* Illegal drug or alcohol abuse
Harnessing mHealth and Social Support to Improve Diabetes Related Health Behavior for Inner-city Patients

In this study, an existing mobile health intervention to improve diabetes self-management will be combined with a social support module and tested for feasibility. The investigators hypothesize that this combination will be feasible and acceptable to both patients and their loved ones.

This will be the first ever evaluation of a highly scalable and low-cost social support intervention for patients with diabetes delivered entirely via mobile phones. TExT-MED FANS (Trial to Examine Text-based mHealth for Emergency Department Patients With Diabetes With Family And Friend Network Supporter) will unite the benefits of mHealth (scalability, ease of access) and social support interventions (personalized motivation, emotional support). The Diabetes FANS text message based curriculum will make it easier for friends and family to become supporters. Additionally, augmenting TExT-MED with the FANS social support module will be more effective than TExT-MED alone. The personalized support of TExT-MED FANS will also be more effective than providing TExT-MED in combination with a community health worker supporter who lacks a pre-existing relationship with the patient. Through this innovative combination, I can create a more cost-effective and diffusible mHealth solution that maintains the personal connection of social support interventions. To date there has only been one study evaluating social support interventions for patients with diabetes using mHealth, but in this study participants were paired with other subjects with diabetes (not friends or family) and it required intensive face-to-face support group time. TExT-MED FANS will provide key insights into the utility of combining social support interventions delivered solely via mHealth in low-income Latino patients. These insights will help future interventions achieve maximal impact on diabetes and other chronic disease management.

Eligibility Criteria:
Inclusion Criteria:

* type II diabetes
* HbA1c \>or=8 at enrollment
* speak English or Spanish
* has support person willing to participate

Exclusion Criteria:

* unable to consent
* pediatric patient
Bioavailability of BI 144807 Given Alone and in Combination With Ketoconazole in Healthy Male Volunteers

This trial investigates the influence of oral ketoconazole on the pharmacokinetics and safety of BI 144807.


Eligibility Criteria:
Inclusion criteria:

1. healthy male subjects

Exclusion criteria:

1. any relevant deviation from healthy conditions
Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy - Recruitment Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy - Recruitment Rhythm

The primary objective is to demonstrate that a higher proportion of responders to deep brain stimulation (DBS) in the anterior nucleus (AN) of the thalamus in refractory epilepsy patients in the SANTE study exhibit a recruitment rhythm relative to non-responders.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled in the SANTÉ study, have been implanted with a complete DBS system, and is currently receiving stimulation in the long-term follow-up phase (post Month 13) of the study
* Patient or legal representative is able to understand and provide signed consent for participating in the study
* Willing and available to attend the visit as scheduled and to comply with the study protocol

Exclusion Criteria:

* Patients unable to tolerate stimulation turned OFF during the testing period
* Are pregnant or suspected of being pregnant
Does a Nasal Instillation of Vardenafil Normalize the Nasal Potential Difference in Cystic Fibrosis Patients?

The purpose of this study is to investigate the effect of a nasal instillation of Vardenafil on nasal potential difference in cystic fibrosis patients homozygous for the F508del mutation

CFTR protein has been shown to be an ohmic, small conductance channel regulated by cAMP intracellular levels that are balanced by degradation through cyclic nucleotide phosphodiesterases (PDE). Several families of PDEs with varying selectivities for cAMP and/or cGMP have been identified.PDE5 is highly specific for cGMP and is involved in the regulation of the intracellular concentration of cGMP in various tissues. Recently, it has been shown, in a preclinical model of transgenic mice, that pharmacological doses of sildenafil and vardenafil, two clinically approved PDE5 inhibitors, stimulate chloride transport activity of the mutant F508del-protein (Lubamba et al, 2008); this parameter has been assessed by means of the nasal potential difference (NPD). An increasing effect of sildenafil on the expression of F508del-CFTR protein (Dormer et al,2005) was originally reported in nasal epithelial cells harvested from patients with cystic fibrosis and cultured on impermeable supports, a configuration that allows interaction of drugs with the apical side of epithelia.

This study aims at investigating the effect of a single local administration of vardenafil on NPD measurements in CF patients homozygous for the F508del mutation.

Eligibility Criteria:
Inclusion Criteria:

* Cystic fibrosis patients homozygous for the F508del mutation as confirmed by a genetic test
* Aged 14 years and older
* Male and female
* FEV1 \>50% of predicted normal

Exclusion Criteria:

* Acute respiratory tract infection or pulmonary exacerbation requiring antibiotic intervention within 2 weeks of visit 1
* Any condition prohibiting the correct measurement of the NPD
* Active or passive smoking
* Planned treatment or treatment with another investigational drug or therapy within 1 month prior to randomisation