cyrilzakka/clinical-trials huggingface dataset:
Why Are Fertility Preservation Patients Not Coming Back?

This is a single-center retrospective study carried out with a phone call follow-up to investigate women's decision not to return for criopreserved ovocytes use after cancer treatment. The study database includes all women who underwent fertility preservation cycles at a third-level university-affiliated center from January 2001 to December 2017.

Patients were asked a set of standardized questions whose purpose was to investigate their present health conditions, cancer treatment and any potential relapses, their family projects and sentimental status, any spontaneous conception, and why they had not yet returned for embryo transfer.

All data were recorded anonymously in our dataset.

All women who underwent oocyte cryopreservation cycles for oncological purposes from January 2001 to December 2017 at Fertility Center of Humanitas Research Hospital, Rozzano (Milano), Italy, were contacted.

The survey's purpose was to investigate their present health conditions, cancer treatment and any potential relapses, their family projects and sentimental status, any spontaneous conception, and why they had not yet returned for oocytes use.

Eligibility Criteria:
Inclusion Criteria:

The study database includes all women who underwent fertility preservation cycles at a third-level university-affiliated center
Study of Injectable Naltrexone and Oral Bupropion Among Cigarette Smokers With Schizophrenia

The purpose of this study is to assess the feasibility and safety of injectable naltrexone (NTX;380 mg) in conjunction with oral bupropion (BUP; 450 mg daily)NTX-BUP administration among individuals with schizophrenia spectrum disorders that smoke cigarettes and to evaluate change on smoking-related measures and symptoms of schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* fluent in English;
* Diagnosed with schizophrenia spectrum disorder that is currently stable;
* Report regular cigarette smoking, average cigarette per day ≥ 5 in the past 4 weeks, and present a breath CO≥10 ppm.
* Meet subjective and objective (urinary drug screen) measures of non-opioid use.
* If female, present a negative pregnancy test, not be currently breast feeding, and agree to use acceptable birth control methods and receive periodic pregnancy tests during the course of the study.
* Able to give written informed consent
* Obtain an Evaluation to Sign Consent (ESC) score above 10.

Exclusion Criteria.

* Have suicidal or homicidal ideation requiring immediate attention.
* Previous use of bupropion or naltrexone in the past 30 days.
* Currently enrolled in treatment for tobacco use.
* Meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5 )criteria for alcohol and other substance use disorders excluding nicotine and marijuana.
* Report a history of epilepsy, seizure disorder or condition increasing risk of seizure, or head trauma with neurological sequelae.
* Have a current eating disorder.
* Be medically unstable or taking medications that are contraindicated with using naltrexone or bupropion.
Variation of Atelectasis Score After High-frequency Percussions in Severe Acquired Brain Injury

Investigators conduced in the Neurological Rehabilitation Unit of the IRCCS "S.Maria Nascente - Fondazione Don Gnocchi", (Milan) a retrospective study on 19 patients hospitalized between September 2018 and February 2021, with the aim of comparing the efficacy of the two devices, MetaNeb® and Intrapulmonary Percussion Ventilation (IPV®).

The efficacy was evaluated considering the change of various measures after two weeks of treatment. The main outcome considered is the atelectasis score, assigned by two radiologists who blindly and retrospectively evaluated it on high-resolution computed tomography (HRTC) images

Patients with severe acquired brain injury (sABI) frequently exhibit pulmonary complications, with atelectasis and/or consolidation of the lower lobes. The atelectasis in critically ill patients is a risk factor for pneumonia and increase the possibility to develop dysventilation syndrome with consequent negative impacts on gas exchanges.

To the best of our knowledge, there is no study investigating the use of the two devices for the treatment of atelectasis in the specific population of non-cooperative tracheostomized patients with sABI who had been spontaneously breathing with no mechanical ventilation support.

Eligibility Criteria:
Inclusion Criteria:

* Spontaneous breathing 24h/24h
* Presence of tracheostomy cannula
* Presence of atelectasis diagnosed through High Resolution Computed Tomography
* Levels of Cognitive Functioning (LCF) ≤ 5
* No pneumothorax
* Consent signed

Exclusion Criteria:

* Age under 18 years old
Management of an Imipenem-resistant Acinetobacter Baumannii Alert in a French University Hospital

Colonization with imipenem-resistant Acinetobacter baumannii (IBA) is an unfavorable event for the patient, especially in intensive care. Indeed, it exposes the patient to the risk of developing serious infections, extremely difficult to treat. ABRI is a particularly resistant bacterium in the environment. When an ABRI epidemic occurs in a department as central to the hospital as a surgical resuscitation department, the control of such an event can be extremely complex. There are few clear and detailed descriptions in the literature of how to manage this type of outbreak, let alone an ABRI outbreak of this magnitude.


Eligibility Criteria:
Inclusion criteria:

* Major subject (≥18 years old)
* Patient having been hospitalized in the surgical resuscitation service of Hautepierre during the ABRI epidemic, between 01/05/2015 and 01/01/2019 inclusive and having been colonized and/or infected by ABRI (according to bacteriological results transmitted to the hygiene service).
* Subject having given his/her agreement, after information, for the reuse of his/her data for the purpose of this research

Exclusion criteria:

* Subject having expressed his opposition to participate in the study
* Subject under guardianship or curatorship
* Subject under legal protection
Psychometric Properties of the SMART Feeding Tool

This observational study aims to evaluate the psychometric properties of a new infant feeding tool called "SMART Tool" in the neonatal intensive care unit. The main questions it aims to answer are:

1. To design a feeding tool to assess oral motor and neurobehavioral skills in neonates
2. To establish psychometrics of the new tool by doing reliability and validity tests.

Research supports the use of infant-directed feeding practices versus a volume-driven approach. Infant-directed feeding practices provide developmentally supportive and neuroprotective care to fragile feeders. In addition, various assessment tools exist to evaluate both breast and bottle feeding. Assessment tools are crucial to feeders with guidance in their decision-making, identifying when an infant is ready to feed and recognizing any feeding-related safety concerns.

The scoring of a tool should provide an opportunity to reflect on the strengths and areas of deficit in feeding events and allow feeders to modify feeding practices for the next attempt or pursue further assessment by a feeding specialist. Few tools exist to evaluate both oral skills and neurobehavioral skills. Some tools available have inadequate psychometric data to support their use. If robust psychometrics exist, the length and complexity of the device may intimidate users and deter consistent use.

The SMART tool was developed to capture the multifaceted aspects of feeding while remaining brief in its administration time. The tool provides an opportunity to evaluate skills and develop a plan after feeding to provide consistent quality care. Additionally, tracking scores over time helps in patient safety for the goal of a high-reliability organization.

This study has two objectives: 1. to create a new tool using synactive development theory and trauma-informed care approach for neonates and 2. to establish this tool's psychometrics (validity and reliability). This multicenter trial will be done over four sites (NICU) in Advocate Aurora Health (AAH) to observe feeding events in neonates. Before and after each feed, scoring of feeding quality will be done to do psychometrics. If the study succeeds, this tool will be employed in clinical care in all the NICUs of AAH.

Acronyms \& Abbreviations:

* AAH: Advocate Aurora Health
* NEOA: Neonatal Eating Outcome Assessment Tool
* NICU: Neonatal Intensive care unit
* PMA: Postmenstrual age (weeks)
* SMART: State of Arousal, Motor Tone, Autonomic Instability, Response to Stimulation, Total Oral Skills

Eligibility Criteria:
Inclusion Criteria:

1. At least 33 weeks, 0 days PMA
2. Able to tolerate enteral feedings
3. Parental consent available

Exclusion Criteria:

1) Respiratory support of more than two liter-per-minute oxygen via nasal cannula
Assessment of Age-related Hearing Loss in HIV-1 Patients

The ageing process is known to be accelerated in HIV-infected patients, compared to the general population.

Normal age-related hearing loss (presbyacusia) is a frequent phenomenon, affecting more than 70% of people above 65 years. It is believed to be mostly the consequence of a mitochondrial damage caused by oxidative stress.

Risk factors for accelerated age-related hearing loss are present in many HIV-infected patients : chronic inflammation, smoking, diabetes, etc.

The global aim is to measure the prevalence of presbyacusia in a well controlled HIV positive population in France, and to compare it to HIV negative controls matched for age and sex.

90 HIV positive patients and 90 age- and sex- matched HIV negative controls will undergo a screening for presbyacusia (pure-tone, speech and evoked-response audiometry).

We expect to find an increased prevalence of presbyacusia in HIV-infected patients, as compared to controls matched for age and sex.


Eligibility Criteria:
Inclusion Criteria:

* Age 40 years and more
* HIV-1 infection known since 10 years and more
* Undetectable plasmatic HIV-1 viral load thanks to antiretroviral therapy (any regimen) for at least 5 years
* CD4 lymphocytes count above 350
* Condition of Cerebral Small Vessel Disease detected recently with MRI

Exclusion Criteria:

* Personal history of otologic pathology or otologic surgery
* Family history of hearing impairment
* Personal history of bacterial meningitis
* Personal history of neurological disease
* Personal history of treatment with ototoxic drugs
* Personal history of treatment with chemotherapy
* Use of illegal drugs (except cannabis or poppers)
* Alcoholism
* Diabetes complicated by retinopathy and/or by glomerular filtration rate \< 60 mL/min and/or by proteinuria \> 300 mg)
* Uncontrolled high blood pressure (WHO criteria)
* MRI contraindication
* Known pregnancy or breastfeeding woman
* No medical insurance coverage
Vaccination Coverage Amongst Children/Young People Attending the PED

In the United Kingdom (UK), most childhood vaccinations are given in the community, although uptake has decreased in recent years. A Paediatric Emergency Department (PED) attendance offers an opportunity to check the vaccination status of children and young people (CYP) and all parents/carers should be asked about this routinely. Those not up-to-date with vaccinations could then be signposted to existing services or perhaps offered a vaccine in the PED.

CYP attending the PED may also have lower vaccination coverage than their peers, so may benefit even more from interventions to increase uptake. However, recall by parents/carers is not always sufficiently accurate to identify those who have not yet received all their age-appropriate vaccinations. The most complete record of an individual's vaccination history is held within their primary care records. However, these records are often in a separate computer system that is inaccessible from the hospital's main computer system, although some information (including vaccination) may be accessed from within the hospital via a third system.

This study aims to see if CYP attending the PED are under-vaccinated compared to their peers and assess the accuracy of parent/carer recall. The results of this study will then be used to inform recommendations for developing better ways to access accurate vaccination data during a PED consultation. If such a system existed, under-vaccinated children could be identified routinely during an attendance, and an intervention offered if appropriate. This would be particularly useful if there was an outbreak of a vaccine-preventable disease such measles.

All CYP (\< 16 years old) attending a PED in a district general hospital in Manchester will be invited to participate. CYP/their parent/carer will be asked to provide consent for their vaccination records to be accessed as well as being asked if the child/young person is up-to-date with all their vaccinations. Approximately 1000 participants will be enrolled.


Eligibility Criteria:
Inclusion Criteria:

* attending the study site PED; under the age of 16 at the time of attendance; able to give consent or accompanied by someone able to give consent

Exclusion Criteria:

* life threatening illness or injury
Evaluation of a Diet in Patients With Senile Dementia

The most common symptoms associated to senile dementia disease are confusion about schedules, hyperactivity... In this sense, these patients have frequently poor nutrition, resulting in malnutrition problems or malnutrition high risk.

The purpose of this study is to assess if the daily intake of a specific nutritional supplement versus a non specific supplement one is related to malnutrition or malnutrition risk reduction and contributes to an improvement in cognitive and functional parameters in patients with senile dementia.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 70 years with neurologist or geriatrician dementia diagnosis (Alzheimer's disease, Parkinson's or mixed), with mild or moderate cognitive impairment degree (Between 24 and 14 MMSE).
* Patients with or at malnutrition risk (Mini Nutritional Assessment screening positive)

Exclusion Criteria:

* Patients with decompensated kidney failure, creatine and/or bilirubin greater than 2, uric acid higher than 8 mg/dl, and glomerular filtration under 60 ml/minute.
* Patients with Diabetes mellitus poorly controlled (Glycemia \> 200 mg/dl)
* Patients with decompensated hypertension.
* Patients with pharmacological treatment or consuming supplements containing specific supplementation of experimental product (omega 3 and/or vitamins supplements).
* Post-stroke vascular dementias.
* Do not achieve any inclusion criteria.
Evidence-based Screening Strategies for Celiac Disease

Main aim: To find evidence-based screening strategies for celiac disease in high risk groups and to find new biomarkers or biomarker combinations for celiac disease diagnostics and follow-up.

The current project will result in the identification of genetic, environmental or downstream biomedical markers that predict the development of celiac disease at the individual level. Moreover, the markers can be exploited in prediction of specific disease risks, manifestations, comorbidities and complications.

Eligibility Criteria:
Inclusion Criteria:

* Cohort 1: Family member of celiac disease patient
* Cohort 2: Previously diagnosed celiac disease

Exclusion Criteria:

* Cohort 1: No previous celiac disease
* Cohort 2: Celiac disease diagnosis not confirmed
Clinical Safety and Efficacy of Fecal Microbiota Transplantation (FMT) in the Treatment of Alzheimer's Disease

To investigate the clinical safety and efficacy of FMT in AD patients, as well as the changes in the gut microbiota of AD patients before and after FMT.


Eligibility Criteria:
Inclusion Criteria:

* The patients (aged 50-85 years) exhibited cognitive decline persisting for over six months;
* Primarily characterized by recent memory impairment and accompanied by reduced daily living abilities;
* MMSE scores ranging from 3 to 26;
* MRI findings revealed atrophy in the medial temporal lobe, hippocampus, and cerebral cortex, along with widened sulci and fissures.

Exclusion Criteria:

* Patients were excluded if they had severe visual, hearing, or language impairments;
* Tumors;
* hepatic/renal dysfunction.
* with conditions mimicking AD symptoms-such as normal pressure hydrocephalus, vascular dementia (VD or VaD);
* Parkinson's disease dementia (PDD)-were also excluded;
* patients who had participated in clinical drug trials within the past 30 days or consumed folate and vitamin B12 at doses exceeding twice the recommended intake were ineligible.
Post Stroke Psychological Distress

Neuro-psychological, cognitive and biochemical assessment matched with MR-Imaging in acute and chronic poststroke conditions.

The study design relates to affective symptomatology, particularly poststroke depression and posttraumatic stress symptoms as well as to cognitive decline due to stress-related hypercortisolemia in the early phase after stroke. Extended MRI studies including a functional connectivity (fc-MRI) paradigm have been incorporated to study on subacute midbrain neurodegeneration as a possible morphological correlate of functional and clinical findings.

Eligibility Criteria:
Inclusion Criteria:

* Stroke in MCA/AchA territory of striato-capsular (at least 125mm³) or non-striatal (10-100cm³) involvement
* MR-imaging can be conducted 24-48 hours of onset
* preserved communication skills

Exclusion Criteria:

* Patients with psychiatric conditions or medication in the last 4 weeks
* severe medical conditions
* limited prognosis
Outcomes in Lower Extremity Soft Tissue Sarcoma Patients After Limb Salvage

This study aims to:

1. validate the Finnish version of the Musculoskeletal Tumor Society scale and the Toronto Extremity Salvage Score lower extremity sections and to
2. assess the functional ability and health-related quality of life (HRQoL) of lower extremity sarcoma patients who have undergone limb salvage surgery.

The first purpose of this study is to validate the Finnish version of the Musculoskeletal Tumor Society scale and the Toronto Extremity Salvage Score upper extremity sections. The second purpose is to chart the functional capabilities and health-related quality of life (HRQoL) of upper extremity sarcoma patients who have undergone limb salvage surgery with local or free flaps.

Patient hospital records are retrospectively reviewed to chart the demographic and clinical data.

The recruitment of patient takes place at the outpatient clinic of Department of Oncology, Helsinki University Hospital. The study includes a cross-sectional assessment at one year follow-up with five validated questionnaires. A follow-up is conducted three years after surgery in the outpatient clinic.

Eligibility Criteria:
Inclusion Criteria:

* Lower extremity soft tissue sarcoma locating in between hip/gluteus to foot
* No metastasis at the time of diagnosis
* Undergone limb salvage surgery
* A minimum of 1 year follow-up
* Written consent
* Age \> 18

Exclusion Criteria:

* Age \<18
* No limb-salvage surgery due to sarcoma
Computerized Treatment for Social Anxiety

The present study aims to examine the feasibility of a computerized treatment for social anxiety disorder. To evaluate the efficacy of the IBM protocol the investigators have developed in reducing evaluation and social threat biases, they will conduct a two-arm randomized controlled trial. Individuals with a diagnosis of social anxiety disorder (N = 50) will be randomized to one of two conditions: 1) IBM or 2) progressive muscle relaxation. Each condition will consist of eight 25 minute treatment sessions. Participants will complete two sessions per week for four weeks and will be administered assessments at pre-treatment, one week post-treatment and at 3-month follow-up. It is hypothesized that: 1) IBM will lead to greater reductions in social anxiety symptoms than the PMR condition; 2) IBM will lead to greater reductions in depression and anxiety than the PMR condition; 3) IBM will lead to greater reductions in threat interpretations and greater increases in benign interpretations than the PMR condition; 4) The effects of condition on social anxiety symptoms will be mediated by changes in social anxiety-related interpretation bias; and 5) The effects of condition will be maintained at the 3-month follow-up assessment.


Eligibility Criteria:
Inclusion Criteria:

* Current diagnosis of Social Anxiety Disorder according to DSM-5 criteria
* SPIN score greater than or equal to 30
* Must report sufficient motivation to complete treatment (i.e., score of at least 5 on a 10 point scale (0 = no motivation and 10 = extreme motivation))

Exclusion Criteria:

* Concurrent psychotherapy or treatment for social anxiety disorder
* Clinically significant suicidality
* Current Alcohol Use Disorder of "Severe" severity or higher
* Current Non-alcohol Substance Use Disorder of "Moderate" severity or higher
* Recent changes (less than four weeks) in psychiatric medication
* History of psychotic symptoms
* May not have participated in a similar computerized treatment program
Effects of Nasal Airflow on Sleep in Tracheotomized Patients

The passage of air through the nasal cavities generates rhythmic oscillations transmitted by the olfactory bulb to the brain, which induces cerebral activation in functional brain areas and is associated with better cognitive performance compared to oral breathing. Consequently, the abolition of nasal ventilation - intrinsic in tracheotomized and ventilated patients - could have deleterious effects on brain activity. Besides the loss of olfaction, the abolition of nasal ventilation could affect brain activity and sleep.

The hypothesis of the present study is that the restoration of nasal stimulation by the passage of humidified nasal airflow in tracheotomized and ventilated patients improves sleep quality, notably with a greater proportion of time spent in REM sleep.

The use of invasive mechanical ventilation via an endotracheal tube or tracheotomy involves bypassing the nasopharyngeal space and abolishing nasal ventilation. The first consequence is the loss of olfactory function. This function is quickly recovered when nasal ventilation is made possible. However, the abolition of nasal ventilation may have consequences beyond the loss of olfaction. The abolition of nasal ventilation in intubated rats inhibits these rhythmic oscillations, which can be restored by nasal sprays. In humans, nasal ventilation induces cerebral activity in functional brain areas and is associated with better cognitive performance compared to oral ventilation. In a model of intubated and ventilated rats, it has been shown that nasal sprays synchronized with the ventilator reduce hippocampal lesions compared to animals ventilated with an endotracheal tube without nasal sprays. Finally, in patients intubated with an endotracheal tube for toxic comas, the same nasal spray system restored brain activity and neural connectivity.

The aim of this study is to test the effects of nasal airflow of the sleep in tracheostomized patients who are still dependent to invasive mechanical ventilation. Patients will be investigated by a full polysomnography during two consecutive nights, with and without nasal airflow on the top of invasive mechanical ventilation, the two nights being randomized.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Admission to PRRS for weaning from ventilation
3. Tracheotomy and nocturnal invasive mechanical ventilation
4. Indication for polysomnography by care team
5. Agreement to participate by patient or trusted person/relative and signature of consent form
6. Affiliation with a social security scheme or beneficiary

Exclusion Criteria:

1. Diseases of the central nervous system: cerebrovascular accident (CVA), multiple sclerosis (MS), epilepsy
2. Psychiatric illnesses (psychoses)
3. Hyperthermia (temperature \> 38.5°C)
4. Agitation, resuscitation delirium
5. Continuous use of sedatives
6. Patients under legal protection (guardianship/curatorship)
7. Patients deprived of liberty by judicial or administrative decision
8. Patients under AME
9. Pregnant or breast-feeding women