cyrilzakka/clinical-trials huggingface dataset:
Prevent Pain and Stress Related Sickleave.

Problems with stress and pain are common reasons for long-term sick-leave, and need preventive interventions. This RCT builds on a successful previous project (see reference section), where a program involving the work place, the individual and occupational health care resulted in decreased sick-leave and healthcare visits and a higher quality of life as compared to TAU for individuals with musculoskeletal pain. This study will replicate and evaluate the mechanisms behind the involvement from the work place. According to the transdiagnostic model, problems with stress and pain are maintained by similar processes. Consequently, the study will be extended to include both problems, and it will be explored how a refined version of the program affects sick leave and work ability in the employees.

Compared to the earlier study, this RCT will include:

1. A focused program targeting supervisors and employees
2. An active control group
3. An evaluation of the effects on both supervisor and employee
4. Knowledge on the mechanisms involved
5. Replication and extension of earlier findings

The project will produce knowledge about:

A procedure for identifying individuals at risk for sick-leave. The effects of a program targeting both workplace and individual to prevent problems with stress and pain.

The role of the supervisor in preventing sick-leave. Mechanisms linked to decreased levels of sick-leave.

Eligibility Criteria:
Inclusion Criteria:

* participating employee has self rated symptoms of stress and/or pain and supervisor also partakes in intervention
* employed at a workplace within Regionhälsans (occupational health care center) uptake area

Exclusion Criteria:

* pain and/or stress symptoms due to medical conditions
* severe psychiatric conditions
* full time sick leave
HCT Effect Among Patients With Psychotic Disorders

Horticulture therapy has been found to have positive effects on individuals with psychotic disorders, promoting social interaction, reducing social isolation, and improving cognitive function. Effectiveness of horticulture therapy in enhancing well-being, reducing symptoms, and facilitating social adjustment in this population

Horticulture therapy involves gardening and plant-related activities as a form of therapeutic intervention, enhance patient to be mindful to current environment and promote relaxation which can reduce symptoms such as anxiety, depression, and social isolation, improve cognitive function, and promote overall well-being .With this respect, there is an urgent need to find a sustainable and eco-friendly solution for this complex issue by returned to nature and utilizing the low cost and current resources at the same time to make a signification reduction in the psychotic disorder's symptoms

Eligibility Criteria:
Inclusion and exclusionCriteria:

did not undergo any other intervention during the HT program used in the study, just routine care in hospital -
The Hormonal and Behavioral Impact of Eating Breakfast

This study is exploring the relationship between food intake behavior and the hypothalamic-pituitary axis (HPA) in women who regularly skip breakfast compared to women who regularly eat breakfast.

Healthy women will be studies in a cross-sectional fashion to examine the metabolic, hormonal and behavioral factors associated with breakfast skipping.

Eligibility Criteria:
Inclusion Criteria:

* Pre-menopausal women (as determined by self-report of menstrual history and confirmation with plasma FSH)
* 20 to 45 years old,
* BMI less than 40 kg/m2
* Stable body weight (fluctuation of less than ± 3%) for past 3 months.
* Breakfast eaters: defined as eating at least 15% of total daily energy intake at a meal between 0400-1000 h at least 6 days/week.
* Breakfast skippers: defined as eating no foods or beverages between 0400-1000h at least 4 days/week or only taking beverages (no solid food) containing less than \~100 kcal.

Exclusion Criteria:

* Erratic/intermittent breakfast eating
* Currently pregnant or lactating
* Shift workers/diagnosed sleep disorders
* Use of tobacco products
* Use of non-prescription drugs/hormone replacement/steroid-based medications
* Diagnosed endocrine, metabolic, or digestive disorder
* Hemoglobin \<11 g/dl
* Plasma Glucose \>120 mg/dl
Comparing the Spanish Version of CANreduce With or Without Psychological Support and Treatment as Usual, Reducing Cannabis Use.

Cannabis is the most widely used psychoactive substance around the world after alcohol and tobacco. Although approximately one in ten users develop serious problems of dependency, only a small number attend outpatient addiction counseling centers. CANreduce is an adherence-focused guidance enhanced web-based self-help program with promising results in German and other languages. It also reaches those users who hesitate to approach such treatment centers and help them to reduce their cannabis use.

This study will test the effectiveness of the Spanish version of the enhanced web-based self-help intervention with psychological support, an enhanced web-based self-help intervention (without psychological support) and a waiting list control in reducing cannabis use in problematic users.


Eligibility Criteria:
Inclusion Criteria:

* Cannabis use of at least once a week 30 days prior to study entry
* At least 18 years old
* At least weekly internet access and a valid email address

Exclusion Criteria:

* Participant reports current pharmacological psychiatric disease or history of psychosis, schizophrenia, bipolar type I disorder or significant current suicidal or homicidal thoughts
* Use of other pharmacological and psychosocial treatments for cannabis use disorders
* Inability to read or write in Spanish
Real-life Effectiveness of the Kaletra Adherence Support Assistance (KASA) Program

The overall purpose of the study was to describe the real-life adherence, effectiveness and safety of the Kaletra Adherence Support Assistance (KASA) Program in human immunodeficiency virus (HIV)-positive patients who were receiving treatment with lopinavir / ritonavir (LPV/r; Kaletra®) in Canada.

The Kaletra Adherence Support Assistance (KASA) Program is a customized support network that has been offered to patients treated with lopinavir / ritonavir (LPV/r; Kaletra®). KASA offers individual counseling with an HIV experienced nurse who assists patients with various aspects of their therapy including life-style changes, emotional stress, and adverse events. Patients enrolled in KASA may also have access to various healthcare professionals (dietician, social worker, psychologist, etc.) or may be offered other types of support (transportation, exercise, etc.), which may help improve their quality of life as well as adherence or compliance while taking LPV/r.

This was a 12-month, multi-center, Canadian Post Marketing Observational Study utilizing a prospective single cohort design. All treatments including participation in the KASA program were according to the decision of the treating physician and the patients and were not affected in any way by their decision to participate in the study. Follow-up was for 12 months at an interval of every six months.

Eligibility Criteria:
Inclusion Criteria:

* Subject is HIV-positive
* On treatment with LPV/r or currently initiated on treatment with LPV/r.
* Has provided written informed consent allowing the use of their data for the study and providing permission for contact by the study personnel.
* Willing to be enrolled in the Kaletra Adherence Support Assistance (KASA) program.
* Prescribed LPV/r as part of his/her treatment by the treating physician.

Exclusion Criteria:

* Not willing to sign an informed consent.
* In the opinion of the treating physician is unlikely to be available for the 12-month follow-up duration of the study.
* Is currently participating in a clinical trial of an investigational product.
* Not willing to participate in the KASA program.
Selection of Farnesoid X Receptor (FXR) Ligands on the Reactivation of Latent HIV Proviruses

The FXReservoir#1 study (NCT03618862) showed that certain FXR ligands reactivate latent viruses in the reservoir circulating in all HIV+ patients tested. These molecules appear as latency reversal agents (LRA) of silent viruses of the HIV reservoir. They can be part of the strategy to eradicate this reservoir, responsible for recurrences of the infection when combined anti-retroviral treatments are stopped.

Two effective leads have been identified on in vitro tests and on ex vivo reactivation using FXReservoir#1. These molecules come from a chemical library of FXR ligands developed by the Inserm team behind the discovery of a role for FXR in viral infections.

A first series of optimized molecules derived from these leads has been synthesized; these molecules, after screening on viral and ADMET (Absorption, Distribution, Metabolisme, Excretion and Toxicity) in vitro tests, must be tested ex vivo on CD4+ lymphocytes from the circulating peripheral reservoir of HIV+ patients in order to select the best molecules with LRA activity. This step is essential before considering the clinical development of an LRA.


Eligibility Criteria:
Inclusion Criteria:

* Criteria relating to the population studied: patients aged 18 to 65 years old, men or women, regardless of ethnic origin.
* Nosological criteria: HIV-1 infection, documented by a complete western blot and/or a detectable viral load at the time of diagnosis, regardless of the viral subtype.
* Pathology severity and progression criteria: patients with a CD4+ count greater than 500 elements/mm3 at the last follow-up visit prior to inclusion in the study. Undetectable viral load for at least six months on stable treatment.
* Criteria relating to treatments/strategies/procedures: Current cART treatment mandatory, regardless of the combination of anti-retrovirals, effective with undetectable viral load. The number of processing lines is not limited.
* Criteria relating to regulation: Absence of opposition

Exclusion Criteria:

* Criteria relating to the population studied: pregnant or breastfeeding women
* Criteria relating to contraindications to the protocol explorations:

Acute or chronic anaemias Acute infections, fever Coagulation disorders, patients taking anticoagulants

- Criteria relating to regulation: Subjects placed under judicial safeguard, guardianship or curatorship Subjects participating in another research with an ongoing exclusion period.
Warrior CARE: Naturalistic Observation and Harm Reduction

This study is looking at therapeutic potential of reducing Tetrahydrocannabinol (THC) levels in regular cannabis smokers using contingency management (CM) intervention in a U.S. veteran population with post-traumatic stress disorder (PTSD).

In this trial, the investigators will recruit veterans with post-traumatic stress disorder (PTSD) who report using cannabis. Veterans will be assigned (via participant self-selection) into either a naturalistic group that will be followed as the participants continue to use cannabis as they normally do (observation only), or into a "THC (tetrahydrocannabinol) reduction group" in which veterans are asked to switch from their typical cannabis product to using a lower THC/higher Cannabidiol (CBD) product; adherence to this switch will be incentivized using a behavioral intervention called contingency management (CM).

Eligibility Criteria:
Inclusion Criteria:

* able to provide informed consent, IQ Score \>80,
* served in branch of the US armed forces, report using cannabis,
* report using cannabis (at least 4x/month)
* test positive for THC in urine drug screen,
* meet DSM-5 criteria for PTSD w/ Sx of at least 6 months duration

Exclusion Criteria:

* urine drug screen positive for any other drugs
* any clinically significant medical problems,
* any current or past serious psychotic or bipolar disorder diagnosis as determined by SCID-5
* at immediate high risk for suicide based on the C-SSRS
* current SUD other than Nicotine Use Disorder, Alcohol (mild or moderate) and Cannabis Use Disorder
* seeking treatment for Cannabis Use Disorder
Validation and Evaluation of the French Version of a Hearing Loss Screening Questionnaire in Adults Aged 60 Years Old and More

Nowadays in France, there is no organized screening of the hearing loss in the elderly; however, it is a very common disease and simples tests to perform to detect it exist. Lots of studies use surveys to identify deaf people; but physicians often consider them too sensitive and less specific because lots of people were classified into " deaf " people meanwhile they have a subnormal tonal audiogram.

Now, it's known that it corresponds to the "Hidden Hearing Loss" concept: it's defined as an auditive disturbance in a noisy ambiance in people with a normal tonal audiometry; corresponding to infraclinical cochlear lesions. These lesions, if detected early, can be prevented to avoid an audition degradation in time.

The aim of the study is to determinate the values of sensitivity and specificity of the HHIE-S survey translated into French, so it could be used as a screening method of hearing loss in the elderly and as a prevention of cochlear damages.

The HHIE-S survey is one of the more used in studies to screen hearing loss in elderly. It has never been validated in French: that's why investigatosr want to test it on the French population, to determine its performance characteristics (sensitivity and specificity). Secondary, investigators study think that people that have high score on the hear loss screening survey, but a normal tonal audiometry have actually a hidden hearing loss. This corresponds to infraclinical cochlear lesions that we want to reveal thanks to a new audiometric test: an audiometry in a noisy ambiance.

The study will take place in a research audiometric room in the department of ENT in Bordeaux. Patients will fill a medical survey the HHIE-S survey translated into French and perform a tonal audiometry test and after it a " speech in noise " audiometry test (VRB in French).

The duration os study is one unique session of 45 minutes including patient information and consent.

Eligibility Criteria:
Inclusion Criteria:

* are 60 years old and more
* are able to express their consent
* are affiliated to the French social security

Exclusion Criteria:

* have known hearing problem of any kind
* have performed an audiogram within the past 6 months
* have required medical examination for any hearing problem
* have had ear surgery of any kind (except form myringotomy tube during the childhood)
* have mental or physical serious injury(ies), which results an impossibility to fill a survey and perform an audiogram
* are under protection schemes
Anal Motor Function in Fecal Incontinence

Traditionnal measurment of anorectal function is perfomed with manometric device using 2 to 3 pressure sensors. The investigators aim to evaluate the usefulness of high resolution manometry to measure anorectal motility

Measurment of anorectal function is traditionnaly made using manometric device composed of perfused or ballon catheters. This allows the recording of anorectal pressure on 2-3 sites. Recently, high resolution manometryu devices using \> 36 pressure channels have been developped. The investigators therefore aim to evaluate the usefullness of the high resolution manometry in patient with fecal incontinence in terms of feasability and diagnosis accuracy

Eligibility Criteria:
Inclusion Criteria:

* patient with fecal incontinence (group "fecal incontinence"
* subject without significant medical or surgical hisotry (group healthy controls)

Exclusion Criteria:

* pregnacy
* unable to speack/understand French language
* not affilitated to the French healthcare system
* history of anorectal disease (for the group of healthy controls) including fecal incontinence, or protocologic surgery
* constipation
* diarrhea
The Effects of Videogames on Depression Symptoms and Brain Dynamics

The purpose of the study is to evaluate the effects of a game-based digital-therapeutics (DTx) medical software device on the symptoms of depression in adults with confirmed major depressive disorder.

The study is a comparator-controlled, randomised, double-blinded intervention study aimed at assessing the effects of the investigational device MEL-T01, "Meliora", on the symptoms of major depressive disorder (MDD). MEL-S01 acts as a comparator. MEL-T01 is a game-based digital-therapeutics (DTx) medical software device developed at Aalto University and is intended to be used as a treatment for MDD together with treatment-as-usual (TAU). MEL-T01 implements personalised cognitive training to alleviate MDD symptoms and improve cognitive performance in MDD subjects.

Subjects volunteering to participate in this investigation are adults whose MDD is confirmed through MINI interview. They have an on-going mental health treatment contact with a mental health professional. The subjects are randomised into three arms with equal probabilities in blocks of six consecutive subjects. Subjects in the MEL-T01 and MEL-S01 arms are engaged in the intervention for 12 weeks while those in the TAU arm are on a follow-up period during these 12 weeks. After this 12-week period, the subjects in MEL-T01 and MEL-S01 arms enter a 12-week follow-up period and the subjects in TAU arm engage with either the MEL-T01 or MEL-S01 intervention (randomised at T0 with equal probability) for 12 weeks.

The subjects are recommended to play the investigational-device game for a total of 48 hours during the 12 weeks of active intervention with a recommended weekly dose of 4 hours. A minimum of 24 hours is needed for inclusion to hypothesis testing. The subjects are limited to a daily maximum of 1.5 hours of game time.

The subjects' mental health symptoms and well-being are evaluated through online questionnaires five times: before subjects are randomised into one of the three groups (T0), and then 4 (T1), 8 (T2), 12 (T3), and 24 (T4) weeks after the study has begun.

Eligibility Criteria:
Inclusion Criteria:

* Between 18-65 year-old
* Suffering from major depressive disorder
* Have an ongoing mental health treatment contact to basic healthcare, specialised healthcare, student healthcare or occupational healthcare
* Has sufficient eyesight with or without prescription
* Has a Windows computer with internet connection and mouse
* Has email and phone number

Exclusion Criteria:

* They have threat of self-harm
* They have addiction to digital games
* They have psychotic disorders
* They are pregnant or breastfeeding
* They have impaired ability in decision making
* They are prisoner or forensic subject
* They have neurological disorders such as epilepsy or brain injury
Neurological Sequelae in Patients With Acute Carbon Monoxide Poisoning

The purpose of this study is to access the clinical characteristics and risk factors for neurological sequelae after acute carbon monoxide poisoning.

After being informed about the study and potential risks, patients meet the inclusion criteria would be given informed consent and entry the study. The data will be collected according to self-designed questionnaire, including :1) The baseline characteristics: would be recorded 6 hours after patients presentation;2) Patients' self evaluation for discomfort symptoms: would be recorded at day 0, week 1, 3 and 6, month 6 and 12；3) Neurological function: would be recorded at day 0, week 6, month 6 and 12.

Eligibility Criteria:
Inclusion Criteria:

* patients present within 12 hours after acute carbon monoxide poisoning;
* age older than 16 years.

Exclusion Criteria:

* pregnant women；
* patients receive oxygen therapy before presentation;
* have history of acute carbon monoxide poisoning within 1 year;
* have been diagnosed any of the following disease: Parkinson disease; cognitive disorder, psychiatric disorders, sequelae of cerebral infarction or hemorrhage, chronic kidney disease and receive hemodialysis, congestive heart failure ( NYHA class III-IV)
Telemedicine in Outpatient Covid-19 Patients

Covid-19, a commonly severe respiratory tract infection caused by the SARS-CoV2 Coronavirus, poses an increasing threat to individual health and health care systems. The individual disease course ranges from mild to life threatening, the pandemic spread leads to a shortage of health care resources including intensive care availability. It should be the overarching goal to allocate sparse health care resources to those most at need and to simultaneously avoid unnecessary blocking of resources by clinically unjustified hospitalizations.

Individuals with preexisting cardiovascular conditions are at the highest risk of health deterioration, even at younger age. Objective criteria for hospitalization are not immediately available in a outpatient settings. Hence, hospitalization and emergency medical contact is often triggered by subjectively interpreted symptoms. The goal of this project is thus to improve the availability of objective measurements in the outpatient setting by means of an innovative, smartwatch mediated telemedicine approach.

To achieve this goal, the investigators will conduct a randomized clinical trial comparing a smartwatch based telemedicine intervention with standard of care. The intervention group will receive regular objective measurements of heart rate, ECG, and SpO2 and will get access to a 24/7 medical care hotline for consultation. The investigators hypothesize that the intervention group will benefit by a significant reduction in unnecessary hospitalizations and unplanned emergency medicine contacts.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed SARS-CoV2 infection and clinical Covid-19 disease
* age ≥18 years
* Presence of ≥1 relevan cardiovascular condition, defined as (or):

  * atrial fibrillation
  * systolic or diastolic heart failure
  * LV ejection fraction \<50%
  * coronary artery disease with past PCI or CABG
  * Past myocardial infarction
  * diabetes mellitus
  * arterial hypertension (treated or untreated)
  * active smoking
  * chronic obstructive lung disease
  * obesity (BMI ≥30kg/m2)
* availability of smartphone and sufficient internet connectivity at home
* ability to use smartwatch
* informed consent to study participation and data protection concept

Exclusion Criteria:

* Participation in concurrent clinical trial
* indication for hospitalization at study entry
Development of a New Method for Analgesia

Aim: To examine a new method to perform local anesthesia in order to diminish the inconvenience by the procedure in patients before performing intubation or oesophagogastroduodenoscopy.

A phase one and two study. part one is performed as a single arm unblinded uncontrolled study in 16 obese patients undergoing awake intubation (investigational pill). The second part is a phase two study randomized single blinded study in 100 patient attending a day case endoscopy unit for oesophagogastroduodenoscopy (investigational pill versus lidocaine suspension).

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted for adipositas surgery
* Patients who attend for oesophagogastroduodenoscopy.

Exclusion Criteria:

* Severe psychiatric diseases
* Alcohol abuse