cyrilzakka/clinical-trials huggingface dataset:
Enhanced CBTi for Older Adult Sleep and Cognition

This randomized clinical trial on 60+ aged and independent-living healthy individuals with symptoms of insomnia will attempt to improve sleep and health outcomes related to sleep with enhancement of a clinical intervention, Cognitive Behavioral Therapy for Insomnia (CBTi).

Telehealth-delivered enhanced CBTi (integrated with a sleep diary app, a therapist dashboard, and data from IoT devices) will be compared to standard telehealth CBTi and to usual treatment with sleep hygiene education. The investigators will determine effects on insomnia (primary outcome) and on clinical sleep metrics (secondary outcome), among other outcomes including cognitive performance, blood biomarkers of ADRD, and therapeutic adherence.

After screening consent and qualification, informed consent, and adherence evaluation with ambulatory devices (1wk), study participants are pseudo-randomized into one of 3 study arms (2:2:1, Enhanced CBTi : Standard CBTi : Sleep Hygiene). The living space of participants is equipped with IoT data collection devices. Participants take surveys related to sleep, have blood drawn, wear ambulatory devices, complete cognitive evaluations, and interact with nearable living space devices and an iPhone interface during a preparation week leading up to an intake telehealth appointment. Baseline data collection (1wk) occurs. Participants then adhere to behavioral therapy directives prescribed at weekly telehealth sessions with a clinically qualified therapist, take surveys related to sleep, complete cognitive evaluations, wear ambulatory devices, and interact with nearable living space devices and an iPhone interface throughout the study intervention period of 6 weeks. During the final week (coinciding with the 6th intervention week), participants have a second blood draw and return all study equipment/devices at the conclusion of participation.

Eligibility Criteria:
Inclusion Criteria:

* Fluent English speaker/reader
* Resident of the state/commonwealth of Pennsylvania for tax purposes
* Ability to complete (sign) own consent form
* Age 60-90 (inclusive, at enrollment)
* Independent Living status (or equivalent; if dwelling in a community living facility)
* Insomnia Severity Index (ISI) screening survey score of \>=11
* Willing to refrain from initiating new therapeutic insomnia interventions that are not a part of this study protocol for the duration of study participation
* Willing to maintain existing physician-directed intervention for issues pertaining to sleep for the duration of study participation
* Has a residence with access to WiFi

Exclusion Criteria:

* Has a pacemaker
* Illicit drug use in the past month
* Diagnosed serious mental health disorder (e.g. psychosis or bipolar depression)
* Currently engaged in evidence-based psychotherapy for Insomnia (e.g. CBTi)
* Cohabiting with a current or previous participant in this study
* Evidence of Cognitive Impairment (a score of \<18 on the abbreviated Montreal Cognitive Assessment \[MoCA\] screening evaluation)
Prediction of Preeclampsia by Comprehensive Markers.

Preeclampsia is one of the most serious complications in pregnancy that causes maternal death and preterm delivery. Series studies has show that the competing risk model developed by the Fetal Maternal FouNdation in early pregnancy has the potential to predict preeclampsia effectively but has show crowd difference. We aim to evaluate the performance of various screening model based on FMF model in Chinese population.

The prospective multi-center observational study aimed to recruit at least 10,000 pregnant woman during the first trimester conducted among 12 medical centers in China. The medical history of each candidate was recorded , blood pressure was measured , blood sample was taken between 11 gestational weeks and 13+6 gestational weeks, to get the PlGF and PAPPA tested. Routine ultrasound was taken with measurement of the uterine artery pulsatility index. The results of the recruited patients were not released to the patients or the doctor. Pregnancy outcome was recorded as to whether the women develop preeclampsia , the SGA babies, or low birth Apgar score and other preeclampsia related adverse maternal and neonatal outcomes. The basic medical information, the mean artery pressure, the PlGF and PAPPA MOM, the UtA PI were used in combination to do the risk stratification, and to develop prediction model for Chinese people.

Eligibility Criteria:
Inclusion Criteria:

1. gestational weeks between 11\~13+6
2. agreed to participate the study
3. live fetus at recruitment.

Exclusion Criteria:

1. first obstetric visit beyond 14 gestational weeks
2. artificial abortion or spontaneous abortion before 20 weeks or lost to follow-up.
3. refused to participate the study.
4. fetus with major chromosome or structural abnormality
Center for Disease Control (CDC) Fax to Quit/Academic Detailing Grant

The purpose of this study is to evaluate Fax to Quit (F2Q) - a strategy that links state quitlines to health care delivery systems. FQ capitalizes upon the healthcare visit as an opportunity for intervention, consistent with the finding that approximately 70% of smokers visit a primary care physician each year. Successful integration of quitlines into healthcare delivery will transform regular healthcare visits into easily implemented, cost-beneficial avenues via which smokers all across America will be routinely inducted into effective cessation intervention. F2Q will be evaluated as follows:

1. Does F2Q increase contacts and "quality contacts," between the quitline and patients who smoke and receive health care at a participating clinic? A "quality contact" is defined as a quitline referral that results in the individual enrolling in the quitline counseling services. This aim will be assessed by measuring the rates of quitline referrals in 49 clinics before and after F2Q has been implemented.
2. Are contact rates and enrollment rates of F2Q increased by "Enhanced Academic Detailing" at clinic sites (with enhanced academic detailing comprising ongoing training/technical assistance as well as performance feedback)?
3. What are the features of the Fax to Quit (F2Q) and Fax to Quit plus Enhanced Academic Detailing (F2Q + EAD) interventions that key clinic personnel found helpful and easy to implement, as well as features that were unhelpful and difficult? This information will be gathered in qualitative assessments that also will identify clinic strategies and organizational features that facilitated successful implementation.
4. What are the incremental costs of instating and sustaining F2Q and F2Q + EAD and how do these costs compare to other quitline promotional strategies (e.g., paid media, medication give-away programs)?


Eligibility Criteria:
Inclusion Criteria:

* Adult (18 years of age or older)
* Smoker seeking medical care from general practice (internal medicine) clinic (clinic enrolled in study)
* Smoker motivated to make a quit attempt

Exclusion Criteria:

* None
Impact of Marketing of Alcohol Products on Young People

Impact of marketing of alcohol products on young people

Responsible for 3.3 million deaths worldwide, alcohol consumption causes diseases (liver cirrhosis, cancers, etc.) and social problems (injuries, road accidents, alcohol dependence, etc.). With one of the highest consumption rate in Europe, alcohol is the second cause of avoidable mortality in France after tobacco (49.000 alcohol attributable deaths in 2009) and its social cost is estimated to 120 billion euros. French teenage population is particularly associated with heavy drinking patterns: in 2014, 49% of 17-year olds declared heavy episodic drinking.

In that regard, several measures are recommended by health actors to combat this issue: minimum unit pricing, sales ban to minor, low blood alcohol concentration for drivers, etc. A specific measure concerns alcohol advertising restrictions. Some countries implemented alcohol advertising regulation laws (Poland, Sweden, Finland, Estonia, etc.), including France with the Evin law passed in 1991. This French law mandates advertising (and packaging) content to strictly convey factual information and objective qualities of alcohol products and thus bans attractive ads based on image and lifestyle evocations (seduction, power, etc.).

The objective of this research is to investigate whether statutory framework for alcohol advertising (e.g., Evin law) can effectively protect people against misleading, suggestive, and appealing content. Little research has been conducted on this topic in spite of WHO's recommendations (most research has explored the influence of exposure to ads but not the impact of content).

Eligibility Criteria:
Inclusion Criteria:

* volunteer males
* aged 18-25
* right-handed
* persons that consume alcohol : " light drinkers " or "heavy drinkers" (defined with the AUDIT scale, scores between 1 to 7)
* written consent and agreement consent will be given
* Affiliated to the French social insurance

Exclusion Criteria:

* color-blind persons
* misuse of psychoactive products (except tobacco) (cannabis : no regular consumers -more than 10 times per month ; no users of other illicit drugs - even for occasional consumption)
* non fluent french speaking persons (people who couldn't understand instructions or asked questions)
* persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty

Related to the MRI:

* Cardiac pacemaker or implanted defibrillator
* Cochlear implant
* Peripheral or neuronal stimulator
* Intra-ocular or brain metallic foreign bodies
* Any other contraindications to MRI
Evaluating Pulmonary Arterial Hypertension in Patients With Systemic Sclerosis

Doppler signals can be recorded from the lung parenchyma by means of a pulsed Doppler ultrasound system incorporating a special signal processing package- the Transthoracic Parametric Doppler (TPD) (Echosense Ltd., Haifa, Israel). Systemic sclerosis patients often develop pulmonary vascular disease leading to pulmonary hypertension. The TPD system may provide important insight into pulmonary blood vessels characteristics by the LDS (Lung Doppler Signals) signals that are related to pulmonary hypertension. The TPD performance in detecting PAH in SSc patients will be assessed in the study.


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to give signed informed consent prior to enrollment
2. Male or female, ≥ 18 years of age
3. Diagnosis of SSc according to 2013 ACR/EULAR SSc Classification Criteria (van den Hoogen 2013): Score ≥ 9.
4. Patients with RHC data available from measurement within 3 weeks prior to TPD assessment
5. No change in or initiation of PAH specific therapy between the last RHC and TPD

Exclusion Criteria:

1. People unable or unwilling to give informed consent.
2. PCWP or LVEDP \> 15 mmHg
3. Any PH etiology outside Group 1 (Dana Point, 2008)
4. Pregnant women
5. Patients having severe chest wall deformity
Analgesic Efficacy of Transmuscular Quadratus Lumborum in Patients Undergoing Total Abdominal Hysterectomy

Patients who have undergone laparotomies often require multimodal postoperative pain regimes. In recent years, abdominal wall blocks have been included to become part of this in order to overcome side effects of systemic opioids and complications from epidural analgesia.

Borglum popularised a new approach on abdominal wall blocks by introducing the transmuscular quadratus lumborum (QL) block. Transmuscular QL block is thought to be effective against somatic and visceral pain as local anaesthetic tends to spread from the site of injection to thoracic paravertebral spaces where the sympathetic chain lies.

The objective of this study is to evaluate the analgesic efficacy of transmuscular QL block in patients undergoing total abdominal hysterectomy (TAH) by measuring cumulative opioid consumption, pain score at rest and on movement 24 hours after TAH. Our hypothesis is patients given transmuscular QL block will have lower cumulative opioid consumption.


Eligibility Criteria:
Inclusion Criteria:

1. ASA I or II
2. Patient's weight \> 50kg
3. Elective TAH

Exclusion Criteria:

1. Body mass index (BMI) \> 35 kg/m2
2. Any contraindications to peripheral nerve blocks i.e. local skin infection, coagulopathy, allergy to LA
3. Inability to use patient controlled analgesia
4. Patient on antiplatelet, anticoagulant or on regular use of opioids, paracetamol, nonsteroidal anti-inflammatory drugs or tramadol for chronic condition
Evaluating an Online Mindfulness-Based Intervention for Insomnia

Insomnia has significantly negative impact on work, quality of life, psycho-somatic health on individuals and imposes substantial economic burdens on society. Mindfulness-based interventions (MBIs) have shown its efficacy in the treatment of insomnia, however the effect of online MBIs need more studies to verify. This study aims to compare the effectiveness of an online MBI named 'Mindful Living With Insomnia (MLWI)' to online CBI-I for insomnia.

This will be an online based, randomized, controlled trial. Investigators will recruit 1000 participants, and will randomize and allocate participants 1:1 to the 'Mindful Living With Insomnia (MLWI)' group (n=500) and the 'CBT-I' group (n=500). The Intervention will involve 12 sessions over 6 weeks course, 2 sessions a week and 0.5 hours per session. The primary outcome will be sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI), severity of insomnia symptoms assessed by the Insomnia Severity Index (ISI), and sleep parameters recorded using Mi Smart Band. The secondary outcomes include perceived stress, anxiety, depression, and mindfulness. Outcomes will be evaluated at baseline, the end of the intervention period, and at a 3-month follow-up. Analysis of covariance, regression analysis, χ2 test, t-test, Pearson's correlations will be applied in data analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 59 years old
2. Being able to read and write Chinese
3. PSQI exceeding 5 at screening
4. Being able to access online services
5. Willing to participate in the study

Exclusion Criteria:

1. Unable to communicate
2. With somatic disorders
3. With mental disorders except for insomnia disorder
4. Being treated with pharmacotherapy
5. Significant current mindfulness practices (\>15 minutes/ day)
Societal Burden Associated with Type 1 Diabetes in Canada

The purpose of this observational study is to estimate the burden of T1D on caregivers of patient with T1D in terms of work productivity, healthcare resource utilization and quality of life.


Eligibility Criteria:
Inclusion Criteria:

1. Parental caregiver of a child recently diagnosed (\<= 2 years) with T1D before study inclusion;
2. Age ≥18 ;
3. Residence in the Canada;
4. Willingess to complete a 20-minute survey
5. Ability to read and understand French or English;
6. Signature of informed consent form (ICF)

Exclusion Criteria:

1. Participation in a clinical trial.
Identification of Pathogens in the Neonatal Intensive Care Unit (NICU)

To aim of this study is to identify the pathogens and their distribution in the NICU and to determine whether empirical antibiotics are suitable for the treatment of sepsis in the unit.


Eligibility Criteria:
Inclusion Criteria:

* Newborns with positive cultures

Exclusion Criteria:

-
Supraglottic Airway vs Tracheal Intubation on PPCs Among High-risk Geriatric Patients

Postoperative pulmonary complications are serious threat to surgical patients, especially to high-risk geriatric patients. There is evidence that laryngeal mask airway is associated with postoperative pulmonary complications in comparison with tracheal intubation. However, conclusion may reverse among frail population such as high-risk geriatric patients. Geriatric patients are often associated with loose mask seal due to physiological changes, which may increase chances of aspiration and pose challenges to intraoperative airway maintenance. It was reported that laryngeal mask airway causes more atelectasis among children, but no report among high-risk elderly. The investigators therefore propose this study to verify the non-inferior effect of laryngeal mask airway compared to tracheal intubation on postoperative pulmonary complications among high-risk geriatric patients undergoing elective non-cardiothoracic surgeries.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 70 years scheduled for elective non-cardiothoracic surgery with an ARISCAT score \> 44 will be included

Exclusion Criteria:

* Exclusion criteria include emergency surgery; anticipated difficult tracheal intubation; laryngeal pathology that might interfere with supraglottic device insertion; high risk of gastroesophageal reflux; participation in any conflicting trial within the past 3 months; or deemed unsuitable for the trial by investigators.
Use of Online Communications to Support Patients and Their Families in the Hospice Unit

The increasing awareness of the importance of palliative care has led, in Israel, to the 2005 Law for the Rights of Persons with Terminal Illness. Still, problems of accessibility to palliative care remain unresolved. The use of e-health services is likely to expand the ability of the medical, psychosocial and nursing staff to reach patients who are either living in the periphery, are unable to make clinic visits or whose family members are housebound in order to be caregivers. This exploratory research is designed to explore the issues, barriers and advantages of e-health care through the perspective of the palliative care staff members, the patients themselves and their caregiving family members.

This study is designed to test the applicability and suitability of e-health services (e.g. by use of SKYPE) to the psychosocial needs of patients and their families who are getting services through home hospice care. In addition, the attitudes of the hospice staff will be investigated to the use of e-health methods. The study will clarify selection criteria, referral pathways and barriers and/or supporting elements that will allow e-health services to be provided in a highly professional fashion. Up to 20 dyads of a patient and their primary caregiver will be recruited from those who are receiving services from the home hospice unit of the Kupat Holim Clalit (General Sick Fund) in the South of Israel.

Eligibility Criteria:
Inclusion Criteria:

* Patient currently receiving care from the home hospice unit,
* over the age of 18,
* able to give informed consent,
* with a computer that can use SKYPE or a smartphone,
* speaking a language of the psychosocial staff person (Hebrew, English, Russian, Arabic).

Exclusion Criteria:

* Brain tumors,
* dementia,
* speech disturbance,
* refusal to participate,
* language other than the four spoken by psychosocial staff members,
* inability to use technology or lack of computer in the home.
Early Nutrition and Neurological Development of Very Preterm Infants

The main goal of this study is to determine the association between:

* the quantity of mother's milk and duration of breastfeeding
* the intake of polyunsaturated fatty acids and iron during hospitalization and the development of preterm infants born with a GA \< 32 weeks.


Eligibility Criteria:
Inclusion criteria:

* infants with a gestational age \< 32 weeks already included in the EPIPAGE2 study
* agreement of parents

Exclusion criteria:

* death during hospitalisation
Pharmacogenetic Study of Antimitotic Therapies Involved in Hepatic VOD in Children With Nephroblastoma or ALL

Hepatic veno-occlusive diseases (VOD) during cancer treatment in children are serious toxicities that have occurred with interruptions of chemotherapy and risk of relapse. In addition, these toxicities have a negative impact on the patient's quality of life, serious long-term sequelae and are potentially fatal in children.

The risk factors associated with the occurrence of these complications are, to date, unknown, at the exception to the exposition to certain treatments (6-thioguanine, busulfan, actinomycin D, radiotherapy, etc.). To understand the effects of this toxicity and those of susceptibility to the disease becomes a major issue in the treatment of these children.

Case-control study, nested in two French multicenter cohorts, on pharmacognenetic, biological and clinical susceptibility factors associated with the occurrence of hepatic veno-occlusive disease during the anticancer treatment for nephroblastoma or acute lymphoblastic leukemia, with centralized genetic analysis.

After obtaining consent (patient or parents for minor patients), a blood sample is collected during the routine follow-up consultation and tubes are sent directly to Paris for the pharmacogenetic analysis at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Children aged \< 18 years old at the time of cancer diagnosis
* Having been treated with a single line of treatment for nephroblastoma or ALL, in France between 2000 and 2018, and who did not receive allogeneic hematopoietic stem cell transplantation
* Weight greater than 5 kg at inclusion
* Informed consent dated and signed by the holder of the parental authority (if minor) or by the patient (if major) to take part in the study
* Affiliated to a Social Security scheme

Exclusion Criteria:

* Unavaibility of constitutional DNA
* Person who receive more than one treatment line for nephroblastoma or ALL in childhood or adolescence
* Pregnant, lactating or parturient women
* Person deprived of their liberty by judicial or administrative decision
* Person under psychiatric care under duress
* Person subject to legal protection
* Person unable to express their consent