cyrilzakka/clinical-trials huggingface dataset:
Negative Pressure Wound Therapy. Therapy Effects and the Impact on the Patient's Quality of Life

Wounds have long been a source of suffering for unfortunate victims and in recent years new complementary methods have been developed in areas where traditional wound treatment has been insufficient. Treating wounds with negative pressure, Vacuum assisted closure® \[VAC\], is a relatively new method of treatment and knowledge about its effect on patients is limited.

Earlier studies haven't been able to answer the question about which groups of patients that are in most favour of the treatment and what impact the treatment has on the patient's quality of life.

It is important with further research since an effective and mild wound treatment can decrease suffering and increase quality of life for the patient. Wound treatment that does not lead to an achieved treatment goal can lead to a risk for the patient and should be avoided.

The project consists of 4 part studies: Study 1 and 2 are chart review studies of a consecutive series of patients treated with VAC at Södersjukhuset during a 3 year period. The patients are described on the basis of medical, surgical and demographical factors. Outcome is treatment results and risk factors for a treatment failure.

Study 3 and 4 are clinical randomised studies with the aim of studying whether treatment with VAC provides a faster and more effective healing of acute and postoperative wounds, and in what way the treatment affect the quality of life and pain of the patients, compared to conventional treatment.


Eligibility Criteria:
Inclusion Criteria:

* acute wounds with substance defect after primary suture demanding further treatment or wounds not primary sutured
* wounds with osteosynthesis, bone or tendon visual regardless wound size
* postoperative infections with wound and substance defect demanding further treatment.
* fasciotomy on extremity

Exclusion Criteria:

* wound size \< 2 cm and depth \< 1 cm
* pressure ulcers, open abdomen and chronic ulcers
* patients with dementia or mental illness so severe that participation in the study is impossible
* patients non in command of the swedish language
* ongoing treatment with warfarin
Testing a Community Intervention to Increase Aspirin Use

This research will test the effect of mass media or mass media plus a clinic based education program will improve appropriate aspirin use for cardiovascular disease prevention. It is a group randomized design of 24 geographic areas in Minnesota with adjacent states serving as controls.

Proposed is a demonstration and implementation project to increase the appropriate use of aspirin for primary prevention of acute myocardial infarction and stroke in the population of Minnesota. Although significant progress in the reduction of acute myocardial infarction and stroke is apparent, these cardiovascular disorders continue as the leading causes of morbidity and mortality. In recent years, and in the context of the positive results from large randomized clinical trials, there is growing consensus that aspirin, when appropriately used, reduces cardiovascular morbidity in men aged 45-79 and women aged 55-79 years. The use of aspirin for primary prevention was recommended in the U.S. Preventive Services Task Force Report in 2009 and more recently in the CDC/CMS 'Million Hearts' ABCs (aspirin, blood pressure, cholesterol, smoking) campaign. Aspirin use is also recommended in the Healthy People 2020 goals. However, many adults who would benefit, are not taking aspirin.

The investigators have been fortunate to receive a large philanthropic donation to launch a campaign to increase appropriate aspirin use in the State of Minnesota. The proposed grant requests funding to evaluate that campaign and the innovative approaches it proposes. In the context of a innovative mass media effort, the investigators intend to test new methods for health system change to increase appropriate aspirin use. Using a two-arm design, the investigators have defined 24 geographic areas in the state that will form the basis for a group-randomized trial. This design will allow us to distinguish the effects of the intervention methods. The interventions will be evaluated by sequential surveys of the target-age general population at baseline and follow-up. Appropriate aspirin use in that population will be the primary goal and endpoint. Simultaneous surveys of adjacent Upper Midwestern states (Iowa, North and South Dakota, Wisconsin) will assess secular trends. Morbidity and mortality data will monitor disease trends and complications associated with aspirin use.

A substantial pilot study in a middle sized community in Northern Minnesota allows us to refine and validate our intervention and measurement methods at the community level. This pilot also demonstrated behavior change of a magnitude supportive of our design assumptions.

This program, if successful, should result in a generalizable program tested in a real world population setting.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men age 45-79.
* Healthy women age 55-79
* per USPSTF 2009 recommendations

Exclusion Criteria:

* History of cardiovascular disease
* aspirin allergy
* serious life-limiting illness
Use Determinants of Smoking Cessation App

The development of mobile applications ("mobile apps") is steadily increasing and appears to be a promising treatment method to help people change unwanted behaviors or maintain a regular relationship with the medical system. Mobile apps aimed at smoking cessation have been shown to be effective. However, if a treatment is not used regularly, it will not have the desired effect. The main objective of this study is to identify what makes a person decide to use a smoking cessation app and to do so regularly. The second objective is to determine what is necessary to achieve long-term change with a mobile app.

Despite the significant decrease in tobacco consumption in France (30% in 2000 vs. 25.4% in 2018), the prevalence of smokers aged 18 to 75 years is still a public issue. Among the new solutions proposed, mobile applications ("mobile apps") seem to be a promising treatment modality. Several advantages to their use are recognized for patients, health professionals and the health system itself. Mobile applications allow accessibility to care and information, the possibility of transposing several proven effective therapeutic principles, the possibility of integrating certain forms of information transmission such as messaging, behavioural feedback and audiovisual media.

Although mobile app development is a growing market, knowledge about the determinants of intention to use this type of technology is very limited, especially for smoking cessation apps. The investigators propose a theoretical model to examine what determines the regular use of mobile apps for smoking cessation among those who want to quit. The investigators use the TAMII model and the operational variables used in a more general study on e-health applications. A chronological organisation based on a three-part behavioural model (antecedent, target behaviour and outcome) is added to the TAMII model. The main objective is to identify the factors of Mobila App Sustain Use (MASU). All definitions of TAM-II will be used : perceived usefulness (PU), perceived ease of use (PEOU) and social norm (SN), as well as the definitions proposed by Choi et al (2014) on the predictors of PU, PEOU and SN.

Eligibility Criteria:
Participants must meet four inclusion criteria for the study:

Inclusion criteria

* Age: Be 18 years of age or older,
* Smoking Status: consider themselves an active smoker
* Motivation to quit: be willing to quit smoking, in the short and medium term.
* Agreement to participate: They must also agree to participate in the study. They will have read the information note where the procedure is described; the researchers presented and their rights to withdraw from the study are recalled.

Exclusion criteria:

* Participants must have a smartphone with an iOS or Android operating system
* Access to the internet to complete the questionnaires
* Download the application and receive the updates it offers.
Study of ITI-007 in Healthy Geriatric Volunteers and in Geriatric Patients With Dementia

A Phase 1b/2, Randomized, Double-blind, Placebo-Controlled, Multiple Oral Dose Escalation Study to Assess Safety, Tolerability and Pharmacokinetics of ITI-007 in Healthy Geriatric Volunteers and in Geriatric Patients with Dementia


Eligibility Criteria:
Inclusion Criteria:

Part 1

* Healthy geriatric volunteers
* MMSE score of \>= 26 at screening
* BMI between 19.0 and 40.0 kg/m2 and a minimum body weight of 50 kg at screening

Part 2

* Geriatric patients with a clinical diagnosis of dementia
* MMSE score of \< 26 at screening
* BMI between 19.0 and 40.0 kg/m2 and a minimum body weight of 50 kg at screening

Exclusion Criteria:

* Any clinically significant illness within 6 months before screening
* Any history of cancer within last 5 years
* History of Hepatitis B or C infection and elevated ALT, AST or bilirubin above the upper limit of normal level
* Any subject considered to be an imminent danger to themselves or others
Heart Rate Variability in Children With Traumatic Brain Injury

Using a prospective cohort of children admitted to the PICU, the investigators will determine HRV monitoring is feasible, if a decreased HRV in the 7 days following moderate or severe TBI in children is associated with a worse outcome 6 months post-TBI and investigate HRV as a tool that can predict adverse events (neurological crisis) within 2 days following TBI.

This is a single center prospective cohort study of 15 children \<18 years, admitted to the PICU at the CHU Sainte-Justine (CHUSJ) with moderate or severe TBI (\<24 hours). Neurodevelopment outcome of children will be evaluated 6 months post TBI.

Eligibility Criteria:
Inclusion Criteria:

* \<18 years
* admitted to the PICU at the CHUSJ
* moderate TBI (Glasgow Coma Scale (GCS): 9-12) or severe TBI (GCS ≤8) as - - assessed 30 minutes after TBI or upon arrival in the emergency room
* written parental consent.

Exclusion Criteria:

* children fulfilling brain death criteria at the time of PICU admission (GCS 3 and loss of all brain stem reflexes)
* children with a pacemaker or with previously diagnosed arrhythmia (HRV monitoring not reliable)
* inflicted trauma (different underlying pathophysiology)
* patients or parents who do not speak or read English or French.
Monitoring Outpatient Blood VolumE in Heart Failure

In patients discharged following heart failure treatment, the consistency of blood volume status and components over time is unknown. The primary objective is to describe the rate of change, if any, of the plasma volume and red blood cell volume following hospitalization and discharge of patients with heart failure.

Over 6 million Americans suffer from heart failure, one of the most prevalent and deadly diseases. High 30-day readmission and mortality rates have persisted despite advances in care. Clinical guidelines suggest blood volume assessment and clinical management to euvolemia or normal blood volume, but standard methods of blood volume diagnosis have been shown to be unreliable. FDA-cleared Blood volume analysis (BVA) has been used to quantify otherwise undiagnosed blood volume derangements in heart failure and other indications. Also, care guided by BVA has been demonstrated to improve inpatient heart failure readmission and mortality. A similar analysis has not previously been performed immediately following hospital discharge, though this period is understood to be challenging due to high variability of patient status, physiology, and compliance.

This is a prospective, single-center, observational open-label study. The primary objective is to quantify changes to plasma volume and red blood cell volume over a 12 week period post-discharge.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized male and female patients with primary or secondary admission diagnosis of acute heart failure exacerbation
* \> 18 years of age
* Able and willing to provide consent
* Reduced or preserved LVEF

Exclusion Criteria:

* Diagnosed with current acute strokes
* Pregnant women
* Severe hypotension requiring resuscitation, intubation or circulatory support
* Cardiogenic shock
* Patients with known cardiac amyloid and hypotension
* Known allergy to iodine or iodinated albumin
Comparison of the Benefits of a Personalized Intervention (Virtual Environment and Device) Compared to Usual Care

The medical environment can create stressful and anxiety-provoking situations for patients, especially during painful procedures, particularly in older adults. These stressful environments have a deleterious effect on the quality of care, even putting the patient at risk and the health care team at risk. The search for a solution is therefore imperative. The evolution of new technologies, such as virtual reality (VR), seems to be an answer to this challenge. Through a multidisciplinary research (psychology and medicine), this project proposes to study the factors allowing to improve the management of older adults during their care using VR. More precisely, different individual factors (age, cognitive level, individual preferences...) and different virtual reality universes (relaxation, landscapes...) on different supports (headsets and touch tablet) will be studied in order to understand the roles of these factors on pain and anxiety management during care procedures. This trial is an interventional, randomized, open-label, single-center study of 100 people over 60 years old. The aim of this project is to improve the quality of life of hospitalized patients but also of caregivers in their work environment. It is expected a significant reduction of pain and anxiety during the intervention with a personalized equipment and environment, compared to usual care conditions. The hypotheisis is also that these interventions, aimed at reducing pain and anxiety in patients, will have beneficial effects on the quality of work life of the caregivers performing the care.

The management of pain and anxiety, during care, will be proposed to patients hospitalized in the geriatric department of the Cimiez Hospital in Nice. After signing the consent form, the equipment and the different virtual environments will be presented to the patient and he will choose his preferred environment.Each patient will be accompanied during a treatment (either in control condition, or in VR condition with a VR condition with a personalised environment (VREP), or in VR condition with a environment (VRNP) for an average of 15 minutes (including the completion of the (including the completion of scales and questionnaires). Assessments will be carried out just before the treatment and just after the treatment.

After the treatment, the caregiver will also be asked to complete a scale assessing After the treatment, the carer will also be asked to complete a scale assessing the treatment (2 minutes on average to complete this scale).

And at the end of the study, the caregivers who participated in the study will be asked to rate their acceptability of VR using the User Experience Survey.

Eligibility Criteria:
Inclusion Criteria:

* Men or Women
* Over 60 years old
* Subject affiliated to the Social Security
* Patient receiving 4 identical cares as part of routine care

Exclusion Criteria:

* Presence of visual and auditory disorders contraindicating the use of a VR headset;
* Unstabilized epilepsy;
* Acute psychiatric disorders
* Vulnerable population
Testing Tactile Aids With Blind Subjects

The objective of this project is to create richer tactile aids by using materials chemistry to create tactile sensations in tactile aids, as an alternative to traditional physical bumps, lines, or textures. These materials are commonly used in household products, but have not yet been used to enrich tactile aids. Successful outcomes are primarily the accuracy with which low vision or blind subjects identify objects made from tactile coatings versus traditional tactile aids. Other outcomes include time to completion of the task, or the number of distinctive categories that participants can identify.

Traditional images and graphics, like mathematical plots or charts, are not accessible to low vision and blind people. Instead, for blind and low vision people, tactile aids are traditionally used to convey abstract concepts. However, tactile aids cannot convey as rich or as dense of information as traditional visual graphics, limiting independence and access to gainful employment for low vision and blind professionals.

The primary reason why tactile aids are inferior to visual graphics is that tactile aids are made from a combination of physical bumps, lines, and labels. Placing too many details on a single tactile aid quickly becomes illegible to the user because the various bumps, lines, and textures blur together, which is known as "tactile clutter".

The objective of this project is to create richer tactile aids by using materials chemistry to create tactile sensations in tactile aids, as an alternative to traditional physical bumps, lines, or textures. These materials are commonly used in household products, but have not yet been used to enrich tactile aids. Successful outcomes include having low vision or blind subjects identify objects made from our tactile materials quicker than traditional tactile aids, or to successfully identify more categories on a mathematical plot than is currently possible with existing tactile aids.

Eligibility Criteria:
Inclusion Criteria:

* Visual Impairment: Participants should be blind or visually impaired for greater than 10 years, either congenitally or acquired.
* Tactile Aid Usage: Participants must use tactile aids regularly.
* Mathematical Knowledge: Participants should have a basic understanding of mathematical plots, equivalent to at least high school geometry.

Exclusion Criteria:

- Limb Conditions: Participants with amputations or outer extremity conditions affecting hand use will be excluded.
A Pathology Reference Laboratory for the Study of Infectious Diseases and Malignant Lymphoma

1. To establish a pathology reference laboratory for the consultation on the diagnosis of infectious diseases and lymphoma.
2. To study the specific pathogens on 100 cases of unexplained death due to infectious diseases in the files of Taiwan CDC and the Forensic Institutes of Department of Law and Justice.
3. To study the distribution of children lymphoid lesions in Vietnam and Taiwan and their virus association.
4. To establish a tissue bank for infectious diseases and lymphoma.


Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of infectious diseases and lymphoma.

Exclusion Criteria:
Evaluation of Shear Wave Elastography Reproducibility in Achilles Tendons and Plantar Fascia

Achilles tendon plays a significant role in walking and sporting activities, particularly through ankle joint and lower limbs stability. Ultrasound imaging can be the first-line examination of choice for patients suspected of having Achilles tendon injury, which is more and more frequent. Nowadays, ultrasound elastography can be used to evaluate the viscoelasticity properties of Achilles tendon, however little is known about the reproducibility of the technique. This study aims to evaluate the reproducibility of supersonic shear imaging SWE™ Young's modulus measurements of shear wave velocity (m/s) in Achilles tendon and plantar fascia.


Eligibility Criteria:
Inclusion Criteria:

* Volunteers with normal Achilles tendon:
* Normal adult aged over 18 years old;
* Without lower limb malformation;
* With no symptoms of Achilles tendon lesion and no negative results of routine ultrasound examination for a possible tendinopathy.

Exclusion Criteria:

* Subjects who failed to meet all inclusion criteria were will be automatically excluded;
* Subjects who did will not wish or could will not sign the informed consent in person.
* Volunteers with abnormal Achilles tendon for any of these reasons:

  * Lower limb malformation;
  * Achilles tendon pain, Achilles tendon disease, surgical history of Achilles tendon surgery, morphologic abnormalities of Achilles tendon ( gray-scale/color Doppler/MRI/plain film);
  * Suffer from systemic, metabolic and endocrine diseases, including but not limited to, diabetes, familial hyperlipidemia (FH), systemic lupus erythematosus (SLE), gout, ankylosing spondylitis, hyperthyroidism, chronic renal failure, etc.
  * Pregnant women;
  * Apply Ongoing hormone hormonal therapy;
  * Athletes
Postoperative Complications in Patients With Obesity Hypoventilation Syndrome

Obstructive sleep apnea (OSA) and Obesity-Hypoventilation Syndrome (OHS) are common conditions in obesity, which may influence the prognosis in patients undergoing surgery. There is a need for simple screening tools to identify such patients at high risk. The current multicenter observational study aims to investigate occurrence of OSA and OHS in obese individuals undergoing elective abdominal surgery and further address its impact on perioperative and postoperative complications.

Obstructive sleep apnea (OSA) and Obesity-Hypoventilation Syndrome (OHS) are common conditions in obesity, which may influence the prognosis in patients undergoing surgery. There is a need for simple screening tools to identify such patients at high risk. The current multicenter observational study aims to investigate occurrence of OSA and OHS in obese individuals undergoing elective abdominal surgery by using questionnaires (STOPBANG questionnaire, Berlin Questionnaire, and Epworth Sleepiness Scale) and arterial blood gases. Perioperative and 72-h postoperative complications will be documented.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective abdominal surgery
* Body-Mass-Index \>=30 kg/m2
* Ability to read and speak
* Signed informed consent.

Exclusion Criteria:

* Use of diuretics
* Use of theophylline
* Use of respiratory depressing drugs
* Severe lung disease (FEV1/FVC\<%50)
* Severe hearth failure (EF\<%35)
* Central nervous system or muscle disease
* Untreated hypothyroidism
* Renal failure (GFR\<50)
* Total parenteral nutrition more than 72 hours
* Hypokalemia
* Hyponatremia
* Hypomagnesemia
* Hypoalbuminemia
* Known sleep apnea or obesity hypoventilation syndrome
* Blood transfusion from blood bank within 72 hours prior to surgery
2 Doses of Ferrlecit Versus Oral Iron to Treat Iron-deficiency Anemia in Peritoneal Dialysis Patients.

This is a phase 3 clinical investigation. Patients who meet the eligibility criteria and provide signed informed consent will be randomized to receive one of two levels of Ferrlecit or oral iron in a 1:1:1 ratio.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, at least 18 years of age.
* Received maintenance peritoneal dialysis therapy for at least 4 weeks.
* Was expected to remain on peritoneal dialysis therapy for duration of study.
* Had predetermined low hemoglobin and transferrin saturation (TSAT) levels.
* Signed patient informed consent.

Exclusion Criteria:

* Had a predetermined serum levels of Ferritin and TSAT
* Pregnant or lactating.
* Had a serious concomitant medical disorder incompatible with participation in the study.
* Had a known hypersensitivity to Ferrlecit or any of its components.
* Unable to cooperate or comply with the protocol.