cyrilzakka/clinical-trials huggingface dataset:
Effect of Virtual Reality on Freezing Phenomenon, Balance, Functional Mobility, Participation in Parkinson's Patients

This study was planned to investigate the use and results of virtual reality applications with specially prepared software for the rehabilitation of freezing phenomenon, which increases the falling anxiety of individuals with Parkinson's disease and causes social isolation. Individuals over the age of 50 who have been diagnosed with idiopathic Parkinson's disease by a specialist neurologist will be included in the study; Individuals evaluated in terms of balance, functional mobility, freezing phenomenon, participation, and cognitive status will be randomly divided into two groups receiving conventional treatment and additional virtual reality. After the preliminary evaluation, they will receive 8 weeks of treatment 4 days a week and will be evaluated after the treatment and 3 months after the treatment. In addition to the improvements that will emerge as a result of the treatments within the scope of the study, it is expected that the virtual reality application created with crowd simulation will provide more effective results in improving the parameters. Knowing the effects of exercises in crowds, which cannot be performed in the clinic, in the treatment of Parkinson's disease patients, whose freezing and freezing-related symptoms are aggravated, especially in crowded environments, will make significant contributions to the field.


Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with Parkinson's disease by a qualified neurologist (diagnosed with idiopathic PD according to UK Brain Bank criteria
* Being between 1-2.5 stages according to the Hoehn and Yahr Staging Scale
* Volunteering to participate in the study
* 50 years of age or older
* Standardized Mini Mental Test score greater than 24
* Patients experiencing an on-off period are in the "on" period
* Not using deep brain stimulation or drug pump
* Ability to walk independently on level ground (Functional Ambulation 3 and above according to classification)
* Having a score of (≥2) on item 3 of the freezing while walking scale

Exclusion Criteria:

* Being any neurological or psychiatric disease other than Parkinson's disease
* Cardiovascular, vestibular or musculoskeletal disease
* Dyskinetic movements
* Having vision problems that cannot be corrected with glasses or lenses
* Hearing problems that cannot be corrected with a hearing aid
* Using an assistive device
Efficacy of Postural Restriction in Treating Benign Paroxysmal Positional Vertigo

The standard treatment of posterior semicircular canal benign paroxysmal positional vertigo is the canalith repositioning procedure or the Epley maneuver. Based on the present literature, there is controversy on the efficacy of post-maneuver postural restrictions.The aim of this study was to conduct a randomized controlled trial to compare the treatment efficacy of post-maneuver postural restriction with CRP alone in patients with posterior semicircular canal benign paroxysmal positional vertigo.

Benign paroxysmal positional vertigo is the most common cause of vertigo. Based on the present literature, there is controversy on the efficacy of post-maneuver postural restrictions.Some study designs were not randomized controlled trials. The present study offers an alternative way of postural restriction to maintain postural restriction as much as possible.

Eligibility Criteria:
Inclusion Criteria:

* Patients with unilateral posterior semicircular canal benign paroxysmal positional vertigo and
* A negative neurologic examination

Exclusion Criteria:

* Secondary benign paroxysmal positional vertigo caused by trauma head injury, inner ear surgery, viral labyrinthitis or Meniere's disease
* Patients with central vertigo, cervical spine, neurologic, otologic, psychiatric diseases
* Patients who used medications that affected the neurologic and otologic systems for less than 48 hours
An Educational Program to Improve Cardiac Arrest Diagnostic Accuracy of Ambulance Telecommunicators

Cardiac arrest is the number one cause of death in Canada. It is often the first symptom of cardiac disease for the victims. Eighty-five percent of victims collapse in their own home. Fifty percent collapse in the presence of a family member. Bystander cardiopulmonary resuscitation (CPR) can improve the chance to survive a cardiac arrest by three to four times, but needs to be started quickly. In most communities, less than 30% of victims receive CPR before the ambulance arrives. Currently, only 8% of cardiac arrest victims can leave the hospital alive.

Many things have been tried to improve the number of times people do CPR. So far, the only thing that really increased the number of times that someone did CPR is when 9-1-1 attendants started to give CPR instructions to callers over the phone. The only problem is that about 25% of cardiac arrest victims gasp for air in the first few minutes. This can fool the 9-1-1 callers and attendants into thinking that the victim is still alive.

The investigators have looked at all the studies on how to help 9-1-1 attendants to recognize abnormal breathing over the phone. The investigators have also learned what should be taught after finishing a large survey with 9-1-1 attendants from across Canada. This survey was done with the help of psychologists and other education experts. It measured the impact of attitudes, social pressures, and 9-1-1 attendants' perceived control over their ability to recognize abnormal breathing and cardiac arrest. Then the investigators developed a teaching tool which helped Ottawa 9-1-1 attendants recognize abnormal breathing. When they could do that, they could also recognize more cardiac arrest.

The main goal of this project is to use the tool developed in Ottawa in more centres to help 9-1-1 attendants save the lives of even more cardiac arrest victims across Canada.


Eligibility Criteria:
Inclusion Criteria:

We will enroll ALL patients with prehospital cardiac arrest (absence of a detectable pulse, unresponsiveness, and apnea):

* That are of presumed cardiac origin;
* That occur in the catchment area of our participating sites; and
* For which resuscitation is attempted by a bystander and/or the emergency responders.

Exclusion Criteria:

* Cardiac arrest witnessed by paramedics after their arrival (no opportunity for bystander intervention);
* Patients younger than 16 years of age (cardiac arrest usually respiratory and rare in this population);
* Patients who are "obviously dead";
* Trauma victims, including hanging and burns; or
* Patients with cardiac arrest clearly of other non-cardiac origin including drug overdose, carbon monoxide poisoning, drowning, exsanguination, electrocution, asphyxia, hypoxia related to respiratory disease, cerebrovascular accident and documented terminal illness.
Wound Dressings Adapted to Wound Exudate and Bacterial Load in Therapy Resistant Large Sized Leg Ulcers

The purpose of the study was to investigated if modern wound dressings adapting to wound exudation and the amount of bacterial colonization can heal large therapy resistant leg ulcers which had a pre-treatment with compresses, ointments and gauze

Background: Moist wound therapy of venous leg ulcers is well established by both in vitro or animal studies and studies at ulcers smaller than 20 cm². Mostly larger venous leg ulcers have a stronger exudation than smaller leg ulcers. Therefore larger ulcers exhibit apparently moist conditions also beneath simple gauze, ointments and compresses.

The purpose of the study was to investigated if modern wound dressings adapting to wound exudation and the amount of bacterial colonization can heal large therapy resistant leg ulcers which had a pre-treatment with compresses, ointments and gauze.

Patients and Methods: In an open, non-randomized prospective trial 139 consecutive patients (86 female, 53 male) with long standing (159 ± 335 weeks) large sized (\> 20 cm², 53.8 ± 90.6 cm²) venous ulcers were included. The pre-treatment with compresses, ointments and gauze and two layer short stretch bandages during the time before consulting our wound outpatient department was compared to the following therapy protocol: After two weeks with four layer bandages compression stockings were applied. After a surgical debridement wound dressings were applied according to exudation (strong: calcium alginate, mean: polyurethane foam, low: hydrocolloid). Critical bacterial colonization was treated by activated charcoal cloth with sil-ver. Criteria for evaluating efficacy were healing time and reduction of ulcer size at the end of observation time.

Eligibility Criteria:
Inclusion Criteria:

* therapy resistant wounds for at least 3 months
* venous disease
* uncle pressure \> 80mmHg
* wound area \> 20qcm

Exclusion Criteria:

* uncle pressure \<80mmHg
Qualitative and Quantitative Study Which Aims to Determine the Specifics of the Announcement for the Diagnosis of Patients With Craniosynostosis and Their Parents to Better Support Them in Their Care

The purposes of this study are:

* to better understand the experience of the announcement for the diagnostic of craniosynostosis to patients and their families to improve the understanding of it and it modes of appropriation
* to compare the announcement process concerning "simple" and "complex" forms.
* to identify the intra-family issues at the announcement of a genetic mutation.
* to reconstruct the care course of patients by analyzing the time of the announcement and the post-operative period.

The supported hypothesis is that the diagnosis of craniosynostosis disturbs the initial family pattern. The different forms of the disease will have different repercussions on intra-family relationships.

The quality of the announcement done by the doctor influences the way how the subjects (parents and patients themselves) appropriate and incorporate it at short, medium and long term.

This research will contribute to the knowledge of this rare disease by different scientific communities: social sciences, medicine and neuropsychology. The originality of this research lies in interdisciplinary teams involved and the cross looks between professional and associative fields.

To better understand the impact of congenital malformations and specifically those related to craniosynostosis, the experiences of children and their families at short, medium and long term, the research will take place in the center of reference "Dysostoses craniofacial", Pediatric Neurosurgery Service at the Necker Hospital in Paris.

Prior to fieldwork, a thorough literature search will be conducted on issues related to our subject: the announcement, psychological, identity, family and social impacts, as well as the specifics of the disease and its manifestations.

The fieldwork will be included in a longitudinal approach which will be located at the intersection of quantitative and qualitative methods.

Eligibility Criteria:
Inclusion Criteria :

Group 1 :

Parents of operated children with a clinical diagnosis of craniosynostosis

Group 2 :

* Parents of newly diagnosed children for a craniosynostosis who will be operated
* Children aged 15 who were operated for a craniosynostosis at least 10 years ago

Group 3 :

* Parents of newly diagnosed children for a craniosynostosis who will be operated
* Children aged 15 who were operated for a craniosynostosis at least 10 years ago

Exclusion Criteria:

* nothing to declare
PINGUIN (Postpartum Intervention in Women With Gestational Diabetes Using Insulin)

The aim of the study is to prove the efficacy of the oral intake of vildagliptin in a daily dose of 100 mg in scope of the development of type 2 diabetes in women with insulin dependent gestational diabetes in their last pregnancy not longer than 9 months after birth.

In this randomized, placebo-controlled, double-blinded clinical phase II study, 140 participants aged 18 years or older and an insulin dependent gestational diabetes in their last pregnancy should be included and treated with vildagliptin or placebo over 24 months, followed by a 12 months observation period. Exclusion criteria are pregnancy and lactation as well as a clinical overt diabetes or islet autoimmunity.

The null hypothesis is that there is no significant difference of diabetes incidence (according to ADA criteria 1997) in both groups.

Primary endpoint is the clinical manifestation of diabetes, secondary endpoints include the improvement of beta cell function (evaluable by C-peptide measurement) and of insulin sensitivity by the treatment with vildagliptin.


Eligibility Criteria:
Inclusion Criteria:

* women with insulin-dependent gestational diabetes during the last pregnancy
* \< 9 months after delivery
* age 18 years or older
* contraception during intervention period (at least 24 months)

Exclusion Criteria:

* pregnancy or lactation
* GADA or IA-2A positivity
* clinical overt diabetes
Gas Composition in the Oropharynx During High-flow Oxygen Therapy Through Nasal Cannula in Healthy Volunteers

Observational, randomized studies and their meta-analyses have shown the high effectiveness of high-flow oxygen therapy through nasal cannulas, reaching 50-60% in acute hypoxemic respiratory failure. Some bench studies showed the advantages of high-flow oxygen therapy compared with standard oxygen therapy, consisting in reducing the anatomical dead space and maintaining a given inspiratory oxygen fraction in the hypopharynx of the mannequin, but the actual state of the gas composition of the hypopharynx was not studied. The study aim is measurement of the inspiratory (FiO2) and expiratory (FeO2) fractions of oxygen, as well as the inspiratory (FiСO2) and expiratory (FeСO2) fractions of carbon dioxide in the hypopharynx of healthy volunteers during high-flow oxygen therapy through nasal cannulas in different physiological conditions.

Randomized controlled trials showed reduction of tracheal intubation in high-flow oxygen therapy through nasal cannulas group in patients with acute respiratory failure as compared to standard oxygen therapy and noninvasive ventilation before Coronavirus disease-19 (COVID-19) pandemic.

The World Health Organization (WHO) declared the outbreak a pandemic of COVID-19 on March 11th, 2020. Since then observational, randomized studies and their meta-analyses have shown the high effectiveness of high-flow oxygen therapy through nasal cannulas (HFNC), reaching 50-60% in acute hypoxemic respiratory failure.

Bench studies showed the advantages of HFNC compared with standard oxygen therapy, consisting in reducing the anatomical dead space and maintaining a given inspiratory oxygen fraction in the hypopharynx of the mannequin, but the actual state of the gas composition of the hypopharynx during HFNC was not studied.

The study aim is measurement of the inspiratory (FiO2) and expiratory (FeO2) fractions of oxygen, as well as the inspiratory (FiСO2) and expiratory (FeСO2) fractions of carbon dioxide in the hypopharynx of healthy volunteers during high-flow oxygen therapy through nasal cannulas in different physiological conditions.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteers
* Age over 18 years
* Written informed consent.

Exclusion Criteria:

* Any primary or secondary lung diseases (COPD, bronchial asthma, interstitial lung diseases, metastatic lung disease, lung cancer)
* Any chronic diseases that can cause respiratory disorders (chronic heart failure, liver cirrhosis, systemic connective tissue diseases, cancer, neuromuscular diseases etc)
* Heart rhythm disturbances
* Body mass index more than 30 kg/m2
* Swallowing disorders
* History of epileptic syndrome
* Recent head surgery or anatomy that precludes the use of nasal cannulas
* Pregnancy and lactation period
* Inability to cooperate with staff.
Comparison Study of Doxorubicin Versus Epirubicin-induced Cardiotoxicity in Patients With DLBCL

The aim of this study is to compare CHOP versus CEOP-induced cardiotoxicity in patients with aggressive B-cell lymphoma. The hypothesis is epirubicin is associated with less cardiotoxicity without compromising the efficacy.

The doxorucin-containing regimen (CHOP) and epirubicin-containing regimen (CEOP) are both frequently used in patients with aggress B-cell lymphoma in out institution. According to a Cochrane meta-analysis, epirubicin is less cardiotoxic than doxorubicin on a mg per mg basis. However, compared with 50mg/m2 of doxorubicin in CHOP, epirubicin was usually used at a higher dose (70mg/m2) to treat non-Hodgkin's lymphoma (NHL). Because of the correlation between cumulative dose and risk of cardiotoxicity, it is reasonable to speculate that CEOP (70mg/m2) has less cardiotoxicity than CHOP (50mg/m2) when both regimens are administered with similar cycles.

Eligibility Criteria:
Inclusion Criteria:

* Previously untreated aggressive B-cell lymphoma
* Age range 18-75 years old
* ECOG performance status 0-2
* Life expectancy of more than 3 months
* Adequate organ function

Exclusion Criteria:

* Previous serious cardiac disease
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
* Pregnant or lactating women
* Serious uncontrolled diseases and intercurrent infection
Use and Acceptability Study of Swallis DSA™ Device for Distanced Swallowing Assessment for Older Adults In Nursing Home CHEZ LES PERSONNES AGEES EN EHPAD

SWALL EHPAD is a multicenter, prospective study on the use and Acceptability Study of Swallis DSA™ Medical Device for Distanced Swallowing Assessment for Older Adults In Nursing Home

Swallowing disorders are frequent in nursing homes and under-assessed, under-diagnosed, and under-managed. The SWALLIS DSA™ investigative device is intended to capture and display pharyngolaryngeal activity in subjects with or at risk for swallowing disorders. This device will thus open the way to telecare in the field of swallowing, the expected benefit of which is to improve access to care in the population of subjects living in Nursing Home

This study aims to verify three hypotheses:

1. The recording of the clinical swallowing assessment performed by the speech therapist at a distance allows observation and an interpretation equivalent to the clinical assessment performed in the presence.
2. This device is accepted by all the beneficiaries (residents) and users (nursing staff) in the usual context of a meal situation in a Nursing Home.
3. This device allows the identification of the events marked by the speech therapist and the analysis of the corresponding vibro-acoustic signals.

Eligibility Criteria:
Inclusion Criteria:

* Subject over 60 years old residing in nursing homes
* Subject with a medical prescription for a swallowing assessment
* Subject affiliated or benefiting from the social security system
* Consent to participate obtained in writing and signed by the subject if he/she is able to give his/her consent, or if necessary by the family or, in case of guardianship, by the legally designated representative

Exclusion Criteria:

* Presence of skin lesion(s) on the neck
* Any serious pathology (severe medical condition or behavioral disorder) where, in the opinion of the investigator, it may place participants at additional risk
* Tracheostomized subject
* Subjects with a nasogastric feeding tube
* Subjects under court protection
Responsible Fatherhood Opportunities for Reentry & Mobility

The purpose of this study is to determine differences among incarcerated or recently incarcerated fathers who receive targeted services and those who do not.

Individuals with a criminal justice background (either incarcerated or on community supervision) and substance use issues will have the opportunity to enroll in services provided by the Mountain Comprehensive Care Center to focus on enhancing fatherhood and family situations.

The primary research questions focus on gauging the intervention's effectiveness in improving healthy relationship and responsible fatherhood outcomes. The intervention has several components targeting parenting skills, job training, relationship education, and case management/reentry support. Primary research questions include:

1. Compared to the counterfactual condition, what is the impact of the intervention on parenting and co-parenting skills/behaviors, as measured by parental role satisfaction and confidence in parenting skills six months after release from incarceration?
2. Compared to the counterfactual condition, what is the impact of the intervention on the likelihood that the participant will be employed six months after release from incarceration?
3. Compared to the counterfactual condition, what is the impact of the intervention on the likelihood that the participant will be in a relationship six months after release from incarceration?

Eligibility Criteria:
Inclusion Criteria:

* Male inmates at specific eastern Kentucky jail sites who are at least 18 years of age and not previously screened for the study
* Participants for the local evaluation will be identified as eligible fathers who have been tried and convicted as an adult; within 3 to 9 months of release; are low-income; and may be an expectant father, a biological father, an adoptive father or a stepfather or who a person who is acknowledged as a father figure (e.g., grandfather) of a dependent child or young adult child up to 24 years of age, and interested in participation.

Exclusion Criteria:

* N/A
Natural History of Amyloid Deposition in Adults With Down Syndrome

The primary objective of this study is to assess the presence of amyloid in non-demented/functionally stable adults with DS as a function of age, dividing the sample into amyloid-positive and amyloid-negative groups. We will also obtain baseline cognitive measures across a range of areas that are often affected by AD.

Specific Aim 1: To assess and compare amyloid deposition (with PiB PET) in non-demented/functionally stable adults with DS across three age cohorts (30-39, 40-49, and \>50 years of age).

Primary Hypothesis 1: At initial assessment, there will be a significantly higher prevalence of amyloid-positive (PiB+) subjects in each succeeding age cohort.

In addition, we will test the following secondary hypothesis:

Secondary Aim 1: To compare the presence or absence of the apolipoprotein-E4 allele to the retention of PiB in various brain areas of the DS subjects.

Secondary Hypothesis 1: At baseline, subjects who carry at least one Apolipoprotein-E4 (ApoE4) allele will show a higher prevalence of being PiB+.

Eligibility Criteria:
Inclusion Criteria:

1. Participant IQ at least 47 (based upon Stanford-Binet V Abbrev. Test Battery)
2. Participant at least 30 years of age
3. DSDS score indicating participant is asymptomatic for AD
4. Reliable caregiver who is capable of providing correct information about the participant's clinical symptoms and history
5. Agreement of caregiver and clinician that participant is able to cooperate with the protocol tasks
6. Participant has provided assent (or consent) and/or parent/caregiver has provided informed consent

Exclusion Criteria:

1. Participant is non-verbal or has extremely limited language skills
2. Score within the "symptomatic" range on the DSDS
3. Any significant disease or unstable medical condition that could affect neuropsychological testing
4. Any problems with vision or hearing that could affect neuropsychological testing
5. Participants in whom MRI is contraindicated
6. Claustrophobia or prior failed experiences of completing MRI scans or blood draws
7. Participant is pregnant or breast feeding
8. History or other evidence of severe illness or other condition that would make the participant, in the opinion of the investigator, unsuitable for the study?