cyrilzakka/clinical-trials huggingface dataset:
Hybrid- Nature: Recovering From Work Through Nature Experiences

The research examines employees' recovery from work stress during visits in nearby nature and when viewing virtual nature with Virtual Reality (VR) goggles. The research provides information on the physiological and psychological recovery of employees who do remote or hybrid work. Recovery is analysed with qualitative and quantitative methods including Firstbeat Life measurements, surveys and interviews. The results can be used in workplaces to develop operating models to promote well-being in remote and hybrid work. The research generates new understanding on how employees' recovery can be supported by means of virtual nature tourism services.

An intervention study with a cross-over research design will be conducted among a sample of 60 employees who do remote or hybrid work. The intervention phase lasts in total of four weeks. During the first week (control phase), the participants continue their daily routine as normal. During the second week of the intervention, a half of the participants are randomised to visit a nearby natural area after finishing work (exposure to nearby nature). The other half of the participants are randomised to view virtual nature videos with VR goggles after finishing work (exposure to virtual nature). On the third week of the intervention, the participants complete nature exposure the other way around. That is, those participants who took part first in exposure to nearby nature will view virtual nature, and vice versa. On the fourth week of the intervention, the participants take part in a semi-structured focus group interview.

Recovering from work in nearby nature and virtual nature is examined through multidisciplinary perspectives of health, well-being, and tourism. The aim of the research is to find new ways of promoting work stress recovery, psychological detachment and restoration among employees when they are making the transition between work time and personal time. These research findings are particularly relevant for fields in which there has been a growing trend for remote or hybrid work. This research is funded by the Finnish Work Environment Fund (Project Number: 220076).

Eligibility Criteria:
Inclusion Criteria:

* Employees who do remote or hybrid work
* Able to communicate adequately in Finnish in order to participate

Exclusion Criteria:

* No exclusion criteria for study participation.
* Firstbeat Life analyses are only available for participants who identify themselves on the basis of biological sex of female or male.
* Firstbeat Life analyses might be unreliable for participants with some health-related issues (e.g., pacemaker, heart transplantation, complex cardiac disease, persistent atrial fibrillation or flutter, or uncontrolled thyroid disease) and therefore measurements will not be performed for them as a part of this research.
Baclofen to Prevent Agitation in Alcohol Addicted Patients in ICU

Background: Alcohol is the leading psychoactive substance consumed in France, with about 15 million regular consumers. The National institute on Alcohol Abuse and Alcoholism (NIAAA) considers alcohol abuse to be more than 14 units of alcohol a week for men and 7 units for women. The specific complication of alcoholism is the alcohol withdrawal syndrome. Its incidence reaches up to 30% and its main complications are Delirium Tremens, restlessness, extended hospital stay, higher morbidity, psychiatric and cognitive impairment. Without appropriate treatment, Delirium Tremens can lead to death in up to 50% of patients.

Methods/Design: This prospective, randomised, controlled study versus placebo will be conducted in eighteen French intensive care units (ICU). Patients with an alcohol intake higher than the NIAAA threshold, under mechanical ventilation, will be included. The primary objective is to determine whether Baclofen is more efficient than placebo in preventing restlessness-related side effects in ICU. Secondary outcomes include mechanical ventilation duration, length of ICU stay, cumulative doses of sedatives and painkillers received within 28 days of ICU admission. Restlessness-related side effects are defined as unplanned extubation, Medical disposal removal, falling out of bed, ICU runaway, immobilisation device removal, self-aggression or towards medical staff. Daily doses of Baclofen/placebo will be guided by creatinine clearance assessment once a day.

Discussion: Restlessness in alcoholic patients is a life-threatening issue in ICUs. BACLOREA is a randomised study assessing the capacity of Baclofen to prevent agitation in mechanically-ventilated patients. Enrolment of 314 patients will begin in June 2016 and is expected to end in December 2019.


Eligibility Criteria:
Inclusion Criteria:

* Adults from 18 to 80 years old with an estimated alcohol intake of:

  * 14 units of alcohol per week during the month before hospitalisation for men aged 18 to 64
  * 7 units of alcohol per week during the month before hospitalisation for women or men older than 65.

AND Intubated, ventilated with an expected duration of mechanical ventilation\> 24 hours at least

Exclusion Criteria:

* Hospitalization \> 7 days
* Baclofen administration before ICU admission (personal treatment or single administration)
* Pregnancy
* Porphyria
* Burned on ICU admission
* Personal treatment including Gamma-hydroxybutyric acid (Alcover/Xyrem)
* Recent stroke or subarachnoid haemorrhage or head trauma with radiological evidence
* Recent or old paraplegia or tetraplegia
* Cardiac arrest with resuscitation manoeuvres before or after ICU admission
* Contraindication to Enteral drug administration for longer than 24 hours
* Lack of social protection
* Hypersensitivity to Baclofen
* Coeliac disease
* Refractory epilepsy
* Dementia, schizophrenia, Bipolar disorder or severe depression.
* Parkinson's disease
* Health care limitation owing to pejorative prognosis
* Tracheotomy on ICU admission
* Patients under guardianship or trusteeship
* Patients already enrolled in interventional study
Extinction Generalization in Exposure Therapy

Patients with anxiety disorders oftentimes express fear responses to more than only one fear-inducing object. The principal aim of this study is to examine whether the beneficial effects of exposure on fear reduction in spider phobia can extend to stimuli which are conceptually similar to spiders (i.e. cockroaches), but have never been presented during the respective treatment.

Fear extinction has evolved as the central mechanism underlying exposure-based treatments. Findings from conditioning studies indicate that fear reduction following a fear extinction procedure can generalize from the extinction stimulus to other conceptually and perceptually related stimuli. This study is aimed at translating these findings to a clinical application and will hence examine whether the basic principles of extinction generalization are applicable to exposure.

Patients with spider phobia will either receive two sessions of in-vivo exposure with spiders or no treatment. Prior to as well as after treatment, patient's fear of spiders will be assessed using the Behavioral Approach Test (BATs) and self-report questionnaires. In addition, BATs with cockroaches will be conducted to examine the effects of exposure therapy on extinction generalization.

Eligibility Criteria:
Inclusion Criteria:

* spider phobia according to Diagnostic and Statistical Manual of Mental Disorders (DSM) -IV criteria

Exclusion Criteria:

* any neurological or neuropsychiatric condition
* current behavioral or pharmacological treatment
* any mental disorder that is considered more severe than specific phobia
Evaluation of the Safety and Potential Therapeutic Effects of Cordstem-ST in Patients With Cerebral Infarction

The objective of the study is to evaluate the safety and the potential therapeutic effects per dose of Cordstem-ST Intravenous Transplantation in Cerebral Infarction subjects

Cohort 1 : Cordstem-ST cells or Placebo on day 0 Cohort 2: Cordstem-ST cells or Placebo on day 0 and day 7

Eligibility Criteria:
Inclusion Criteria

1. Male or female subjects between 19 to 80 years of age (inclusive) at the time of screening visit
2. Subjects who are able to receive intravenous Cordstem-ST Transplantation within 7 days (168 hours) of stroke onset
3. Subjects with diagnosis of Cerebral Infarction confirmed by the following criteria assessed at the screening visit

   * NIHSS score between 5 and 20 (inclusive)
   * Acute ischemic lesion involving anterior circulation territory identified in the diffusion weighted MRI
4. Signed informed consent

Exclusion Criteria

1. History of intracranial hemorrhage
2. Subjects who are suspected to undergo endarterectomy during the study period. Subjects who received the former procedures not due to cerebral infarction more than 3 months ago, are eligible.
3. Subjects with hemorrhagic transformation on brain images, except for petechial hemorrhage ('H1' according to the ECASS classification)
4. Subjects at the high risk of developing brain herniation
5. History of dementia
6. History of epilepsy
7. Subjects who have been treated or diagnosed with schizophrenia, depression, or bipolar disorder within the past 6 months
8. Subjects with recent (≤3 months) myocardial infarction or stroke other than the index stroke.
9. Subjects must not have the following conditions in laboratory tests

   * ALT or AST: More than 2.5 times the upper limit of normal
   * Serum creatinine: More than 1.5 times the upper limit of normal
   * Total bilirubin: More than 2.5 times the upper limit of normal
   * Platelet count: less than lower limit of narmal
10. Subjects who are HBV, HCV, HIV, VDRL positive
11. Subjects in poor general condition due to medical conditions or subjects with severe cardiovascular, gastrointestinal, pulmonary, endocrinologic diseases
12. Subjects with active lung diseases, based on chest X-ray
13. Subjects with abnormal coagulopathic conditions (thrombocytopenia, congenital coagulopathy, etc.). Medical use of oral anticoagulants is permitted.
14. Subjects with known allergies to protein products (Bovine serum) used in the cell production process.
15. Subjects with history of pulmonary embolism or deep vein thrombosis
16. Subjects with history of malignancy
17. Pregnant or lactating women
18. Women of childbearing age who reject to practice contraception with one of the following methods

    * Use a condom
    * Use of contraceptive (oral, dermal, or injectable)
    * Use an intra-uterine contraceptive device
19. Subjects with a history of alcohol abuse (\>30g/day) or drug abuse
20. Subjects who cannot undergo MRI scanning
21. Subjects who cannot conduct the scheduled monitoring visits
22. Subjects who is determined to be inappropriate by the investigators
The Effects of High Intensity Interval Exercise in Obese

Obesity is a complex and multifactorial disease. Excess weight is related to endothelial dysfunction, inflammation and oxidative stress which increases the risk for cardiovascular diseases. High-intensity interval exercise can release vasodilatory substances and promote increased muscle blood flow.

This study evaluated the effects of the recovery interval duration (1 vs. 3 min) in high intensity interval exercise (HIIE) on the hemodinamics responses in obese individuals. Twelve obese subjects (27 ± 3.8 yrs) were evaluated, who underwent three experimental sessions with a randomized crossover design: one control session (no exercise) and two HIIE sessions with the same workload (10 x 1min @92%VO2max / 1\[HIIE 1\] or 3\[HIIE 3\] min @0%). Forearm blood flow (FBF) and blood pressure (BP) were measured before and after the experimental sessions. Heart rate and relative perceived exertion were assessed during HIIE.

Eligibility Criteria:
Inclusion criteria for the study were obesity and the conditions of being insufficiently active, non-smokers and without previous history of: heart disease, obstructive or restrictive pulmonary diseases, and orthopedic morbidities. Fifty-one (51) subjects were evaluated for eligibility, and 39 subjects were excluded after an initial interview since they did not meet the aforementioned inclusion criteria.
Improving COVID-19 Vaccine Uptake Among Black and Latino Youth

Black and Latino youth may be less likely to get the COVID-19 vaccine than White youth. In this study we will work with community members to come up with ways to help Black and Latino families learn more about the COVID-19 vaccine and get the COVID-19 vaccine. We will test these ideas out in pediatric primary care clinics. This study will help us make sure that all youth have an equal chance of getting the COVID-19 vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Youth 0-21 years of age and their caregiver
* Receiving care at one of four Nemours primary care practices selected for this study

Exclusion Criteria:

* None
Insulin Analogues and Severe Hypoglycaemia

Severe hypoglycaemia is hampering the lives of many diabetic patients. The effect on the occurrence of severe hypoglycaemia during two different insulin regimens are to be investigated. In total, 250 hypoglycaemia prone type 1 diabetic patients will be randomised to receive analogue and human insulin for one year in random order. Outcomes will be number of episodes of severe hypoglycaemia

The primary objective is to evaluate the effects of insulin analogue and human insulin on incidence of severe hypoglycaemia in type 1 diabetic patients prone to hypoglycaemia.Secondary endpoints are effect on incidence of symptomatic and asymptomatic documented hypoglycaemia.

Study Design: An open, randomised, controlled, cross-over multi-centre study. Each treatment period lasts for one year. Patients will be randomised to treatment with basal bolus therapy with insulin detemir / aspart and insulatard / actrapid in random order. Endpoints will be assessed during the last 9 months of each treatment arm.

Patient population: 250 type 1 diabetic patients with a history of two or more episodes of severe hypoglycaemia during the preceding year.

Interventions: Basal bolus therapy with insulin detemir / aspart and insulatard / human actrapid in random order. Each treatment period lasts 12 months.

Methods: Patients will record all events of severe hypoglycaemia, documented symptomatic and asymptomatic hypoglycaemia in a diary and report all events of severe hypoglycaemia by telephone within 24 hours. All patients will be instructed to do and record home blood glucose monitoring (SMBG) i.e. 7 point profiles twice per week and nocturnal measurements once every month.

Outcomes: Severe hypoglycaemia, documented symptomatic and asymptomatic hypoglycaemia Efficacy: Number of reported episodes of severe, documented symptomatic and asymptomatic hypoglycaemia during the last 9 months of treatment - during daytime and night time.

Safety: Adverse reactions

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes for 5 years.
* Age\>18 years.
* Two or more episodes of hypoglycaemia during the last year,

Exclusion Criteria:

* History of Addisons disease
* Growth hormone deficiency or untreated myxoedema
* CVD within 6 months
* Cancer within 5 years
* Alcohol or drug abuse
* Pregnant or lactating women
* Fertile women without effective contraception
* Participation in another trial within 30 days
* Inability to understand the informed consent
the Study of Effect of Chronomodulated Chemotherapy on the Dendritic Cells Subsets in the Treatment of Advanced Nasopharyngeal Cancer

This study is to observe and compare the effect of docetaxel plus lobaplatin induction chemotherapy combined with lopoplatin chemoradiotherapy and TPF induction chemotherapy combined with cisplatin chemoradiotherapy on dendritic cells subsets in the treatment of locally advanced head and neck squamous cell carcinoma.

TPF program is currently the local advanced head and neck squamous cell carcinoma commonly used inducing chemotherapy, cisplatin is the preferred drug for the same period chemotherapy.Dendritic cells (DC) play an essential role in the induction and regulation of immune responses.The effect of radiation and chemotherapy is closely related to the patients' immune function.In this study, Phase II clinical trials were performed. Patients with locally advanced head and neck squamous cell carcinoma were randomly divided into experimental group and control group. The trial group was treated with docetaxel + lorosine-induced chemotherapy combined with lorplatin concurrent radiotherapy and chemotherapy. The control group was treated with TPF Cisplatin concurrent chemotherapy, observed the relationship between dendritic cells subsets and clinical prognosis of patients, to provide a new method for the treatment of locally advanced nasopharyngeal carcinoma and technical support

Eligibility Criteria:
Inclusion Criteria:

1. initial treatment of advanced nasopharyngeal carcinoma Ⅲ-Ⅳ patients with pathologically confirmed (according to 2010 UICC staging, T3-4, N0-3), without evidence of distant metastasis (M0). Have measurable tumor lesions.
2. KPS≥70 points.
3. the age of 18-70 years old, male or female.
4. no major organ dysfunction; normal bone marrow function (WBC ≥4.0 × 109 / L, platelets ≥100 × 109 / L, hemoglobin ≥90g / L), normal liver function (total bilirubin, alanine aminotransferase, aspartate aminotransferase ≤1.5 times the upper limit of normal), normal renal function (creatinine ≤ 1.5 times upper limit of normal).
5. understand this study and signed informed consent

Exclusion Criteria:

1. Three months in the use of Chinese herbal medicine or immune modulators
2. distant metastasis.
3. who had received prior chemotherapy.
4. patients have physical or mental illness, and by researchers believe that patients can not be completely or fully understood in this study possible complications.
5. pregnancy (via the urine or serum β-HCG test confirmed) or during lactation. serious complications, such as uncontrolled hypertension, heart failure, diabetes and so on.
Cyclophosphamide for Acute Exacerbation of Idiopathic Pulmonary Fibrosis

Acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF) is a major event of IPF with an annual incidence between 5 and 10% and is responsible for the death of one third of IPF patients. When AE-IPF occurs, it is associated with poor survival with an overall mortality at 3 months upper of 50%. To date, no treatment has been proved to be effective in AE-IPF but the efficacy of cyclophosphamide (CYC) on survival has been suggested, mainly by retrospective series and needs to be confirmed. This confirmation is mandatory to improve prognosis of AE-IPF but also to avoid unsuspected deleterious effect as it as been shown with immunosuppressor in stable IPF.

Acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF) is a major event of IPF with an annual incidence between 5 and 10% and is responsible for the death of one third of IPF patients. When AE-IPF occurs, it is associated with poor survival with an overall mortality at 3 months upper of 50%. To date, no treatment has been proved to be effective in AE-IPF but the efficacy of CYC on survival has been suggested, mainly by retrospective series and needs to be confirmed. This confirmation is mandatory to improve prognosis of AE-IPF but also to avoid unsuspected deleterious effect as it as been shown with immunosuppressor in stable IPF.

Eligibility Criteria:
Inclusion Criteria :

* ≥18 years of age
* Definite or probable IPF diagnosis defined on 2011 international recommendations
* Definite or suspicion of AE defined by IPFnet criteria after exclusion of alternative diagnosis of acute worsening.
* Efficient contraceptive method within 1 month for women and 3 months for men after the last dose of treatment
* Affiliation to the social security
* Able to understand and sign a written informed consent form

Exclusion Criteria:

* Identified etiology for acute worsening (i.e. infectious disease)
* Known hypersensitivity or contra-indication to CYC or to any component of the study treatment
* Patient on mechanical ventilation
* Active bacterial, viral, fungal or parasitic infection
* Active cancer
* Patient on a lung transplantation waiting list
* Treatment with CYC in the last 12 months
* Patient participating to another clinical trial
* Pregnancy or lactation
Dextromethorphan Added on for Children With Chronic Irritability

Dextromethorphan Added on for Children With Chronic Irritability

Objectives:

It is known that the etiology and mechanism of neuropsychiatric diseases may be related to nerve inflammation. It has been found that dextromethorphan (DM) is an active ingredient in cough-remedies, which can protect neurons in glial cell cultures in the rat brain from inflammatory substances. Although the mechanism of DM is still unknown, it may be related to the regulation of immune dysfunction. Therefore the purpose of this present study was to investigate the adjuvant treatment with DM in the children and adolescents with chronic irritability.

Methods:

This randomized double-blind clinical trial will evaluate 120 outpatients, aged between 7 and 17 years, with chronic irritability. The study subjects will be randomly assigned into one of the two groups: receiving routine medicine plus DM or routine medicine plus placebo for 8 weeks. Assessments comprising the parents' reported Mood Disorder Questionnaire (MDQ), Affective Reactivity Index (ARI), the Chinese version of the Child Behavior Checklist (CBCL-C) scale, the Swanson, Nolan and Pelham Questionnaire (SNAP-IV), the Sleep Disturbance Scale for Children (SDSC), Problematic smartphone use (PSU) and Checklist for Autism Spectrum Disorder-Chinese Version (CASD-C). Comparison will be done between groups at baseline and at 8 weeks before-and-after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 7 to 17 who have irritability symptoms will be recruited. They will be screened for the irritability symptoms with ARI scale.

Exclusion Criteria:

* Patients who are not willing to participate in the study after detailed explanation.
* Patients who could not follow the investigator's instructions.
* Patients who have problems to express questions or emotional problems exactly.
* Patients who have severe neurological or mental illness like epileptic disorder, history of stroke, schizophrenia, bipolar disorder, mental retardation or uncontrolled suicide risk.
* Patients who have severe medical illness or surgical conditions like uncontrolled abnormal thyroid function, history of heart attack, uncontrolled hypertension.
* Patients who are allergic to methylphenidate or dextromethorphan.
* Patients with autoimmune disorders
* Patients with asthma or severe infection disorder currently or in the previous two months to avoid the influence of the level of cytokines.
Efficacy Study of Minoxidil Lotion Versus Combined Minoxidil and Finasteride Lotion to Treat Male Pattern Hair Loss

The purpose of this study is to compare the efficacy of 3% Minoxidil lotion and 3% Minoxidil with 0.1% Finasteride lotion for 6 months in male pattern hair loss.


Eligibility Criteria:
Inclusion Criteria:

* male, age 18-15 years
* androgenetic alopecia grade 3V to 5 ( Norwood-Hamilton classification)

Exclusion Criteria:

* use minoxidil in 6 months
* use finasteride in 12 months
* use ketoconazole, tar, selenium shampoo, topical tretinoin, topical steroid in 2 weeks
* seborrheic dermatitis or psoriasis on scalp
* history of allergy to minoxidil, finasteride