linjc16/ctgov huggingface dataset:
Impact of the Change in Hospital Service of Caregivers During COVID-19 Health Crisis on Operational Strain

Study Overview
=================
Brief Summary
-----------------
The French Armed Forces Health Service caregivers are confronted with specific operational constraints that require physiological adaptation on a daily basis. These constraints generate an allostatic load resulting from the body's adaptation to the environment through stress response systems. The COVID-19 health crisis has modified the physical and psychological constraints linked to usual activity, in particular by imposing versatility to caregivers. The research hypothesis is that carers who have undergone activity reorganisations, and in particular a change of service, are more affected by the health crisis than those who have remained in their service and have continued an activity close to their usual practice.

Official Title
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Impact of the Change in Hospital Service of Caregivers During COVID-19 Health Crisis on Operational Strain

Conditions
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Burnout, Caregiver

Intervention / Treatment
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* Other: Online questionnaire


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: To be caregivers Have been in employment between March 15 and May 15, 2020 Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hospital service change<br>This group is composed of caregivers who changed hospital service during COVID-19 health crisis. | Other: Online questionnaire<br>* Participants will have to complete 3 online self-questionnaires: the first one at enrollment, the second one 1 month after enrollment (M1) and the third one 3 months after enrollment (M3). Each questionnaire will take an estimated 20 minutes to complete.<br>|
| No hospital service change<br>This group is composed of caregivers who have not changed hospital service during COVID-19 health crisis. | Other: Online questionnaire<br>* Participants will have to complete 3 online self-questionnaires: the first one at enrollment, the second one 1 month after enrollment (M1) and the third one 3 months after enrollment (M3). Each questionnaire will take an estimated 20 minutes to complete.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Burn-out Assessment tool (BAT) score at enrollment. | Burn-out Assessment tool (BAT) score at enrollment will be compared between the hospital service change group and the no hospital service change group. | At enrollment |
Effective Connectivity in Patients Receiving Spinal Cord Stimulation: an fMRI and EEG Dynamic Causal Modeling Study

Study Overview
=================
Brief Summary
-----------------
In this study, a retrospective analysis will be performed on collected data of 14 patients with Failed Back Surgery Syndrome, treated with Spinal cord stimulation. In separate studies, fMRI and EEG recordings were made in resting state conditions on two time points. The fMRI assessments and EEG recordings were performed before the SCS implantation (baseline) and repeated around 3 months after the definitive SCS implantation. During both assessments, patients were asked to fill in a VAS diary for their leg and back pain (scores from 0 to 10). The aim of the current retrospective study is to correlate the clinical data obtained from the VAS scores, with estimates of effective connectivity (obtained from fMRI and EEG). Effective connectivity will be calculated by using dynamic causal modeling (DCM) on the baseline data and the data obtained 3 months after SCS. The aim is to evaluate whether DCM data of EEG is equally/worse/better correlating with the clinical data as DCM data of fMRI.

Official Title
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Effective Connectivity in Patients Receiving Spinal Cord Stimulation: an fMRI and EEG Dynamic Causal Modeling Study

Conditions
-----------------
Failed Back Surgery Syndrome

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is at least 18 years old. Diagnosis of FBSS with predominant leg pain (VAS) > 5) and non-dominant back pain. Cognitive and language functioning enabling coherent communication between the examiner and the subject; Failed conservative treatments for pain including but not limited to pharmacological therapy and physical therapy Stable neurologic function in the past 30 days Subject is included in the previous studies and both EEG and fMRI data are available. Exclusion Criteria: Female subject of childbearing potential is pregnant/nursing, or plans to become pregnant during the course of the trial Subjects currently has an active infection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation pain intensity scores with estimates of effective connectivity | The investigators will evaluate the degree of correlation between pain intensity ratings and effective connectivity based on fMRI data and between pain intensity ratings and effective connectivity based on EEG data. | The change between baseline and 3 months after the definitive implantation of the neurostimulator | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
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EEG, fMRI, correlation clinical data, effective connectivity
Subclinical Hypothyrodism and Ovarian Reserve

Study Overview
=================
Brief Summary
-----------------
This study aimed to evaluate the potential association of subclinical hypothyrodism and ovarian reserve in reproductive age in age groups more than 35 and age groups less than 35 using retrospective study included women with subclinical hypothyrodism and controls .Evaluation of potential association of antithyroid antibodies positivity on ovarian reserve Primary outcome: Measure the association of SCH with ovarian reserve markers (basal FSH ,LH/basal AFC /AMH)

Detailed Description
-----------------
Thyroid dysfunction is one of the commonest disorders in women of reproductive age .there is association between subclinical hypothyrodism and infertility and ovarian reserve .It's known that subclinical hypothyrodism can be associated with reduced ovarian reserve in women more than 35 years old .Aclear association between subclinical hypothyrodism and ovarian reserve not established in reproductive age in women less than 35 .This retrospective study investigate serum thyroid hormone /Antithyroid hormone ,ovarian reserve markers (basal FSH,AMH,Antral follicle count on day 2-4/prolactin level .

Official Title
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Evaluation of Ovarian Reserve in Women With Subclinical Hypothyrodism in Reproductive Age

Conditions
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Fertility Disorders

Intervention / Treatment
-----------------
* Behavioral: retrospective charts reviewing


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: All reproductive age groups included women less than 35 and women more than 35 Exclusion Criteria: Previous ovarian surgery Women with long term thyroid hormone replacement Endometriosis History of radiotheraby

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: retrospective charts reviewing|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the association of SCH with ovarian reserve markers (basal FSH ,LH/basal AFC /AMH) | This study aimed to evaluate the potential association of subclinical hypothyrodism and ovarian reserve in reproductive age in age groups more than 35 and age groups less than 35 using retrospective study included women with subclinical hypothyrodism and controls .Evaluation of potential association of antithyroid antibodies positivity on ovarian reserve | 48 months |
Metabolomics of Insomnia-Related Hyperarousal

Study Overview
=================
Brief Summary
-----------------
Individuals with insomnia have been shown to have higher overall metabolic rates compared to good sleepers, but it is not known which metabolic processes are involved. The goal of this study is to compare a wide array of metabolic processes in 15 people with insomnia and 15 good sleepers. We hypothesize that there will be distinct metabolic processes that are functioning differently in those with insomnia.

Official Title
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Metabolomics of Insomnia-Related Hyperarousal

Conditions
-----------------
Primary Insomnia

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Criteria for primary insomnia: subjective complaint of difficulty initiating or maintaining sleep, waking up too early or nonrestorative sleep daytime consequences as a result of the poor sleep duration of at least 1 month sleep disturbance is not secondary to a medical or psychiatric condition Criteria for good sleepers: -subjective report of consistent good sleep Exclusion Criteria: significant medical or psychiatric illness diagnosis of a sleep disorder other than insomnia women who have been pregnant or lactating in the past 6 months non-fluency in spoken or written English Current shift work defined as working during the evening or night shift Current use of medications that affect sleep BMI >27

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Individuals with insomnia<br> | |
| Good sleepers<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Metabolites Elevated Relative to the Other Group. | Metabolomics analysis of blood samples were carried out using Spectroscopy. This approach allows for rapid, unbiased and quantitative metabolic profiles ('fingerprints) to be acquired. A total of 70 metabolites were measured and compared between individuals with insomnia and good sleepers. | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Efficiency Percentage on Overnight Sleep Study | Participants will have their sleep measured with polysomnography for one night. The sleep of individuals with insomnia will be compared to that of good sleepers. Sleep quality is defined as sleep efficiency, which is calculated at total sleep time / total time spent in bed x 100. It indicates the % of time spent asleep while in bed. | 1 night |
Multiple-Dose Study Apixaban in Pediatric Subjects With an Indwelling Central Venous Catheter

Study Overview
=================
Brief Summary
-----------------
CV185-079 is a multiple dose Apixaban Pharmacokinetics/Pharmacodynamics (PK/PD) study in pediatric subjects. The objective of this study is primarily to study the PK/PD of Apixaban in pediatric subjects with a central venous catheter.

Official Title
-----------------
Multiple-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Apixaban in Pediatric Subjects With an Indwelling Central Venous Catheter

Conditions
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Venous Thromboembolism

Intervention / Treatment
-----------------
* Drug: Apixaban


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Subjects with chronic stable disease with any type of functioning CVC in the upper or lower venous system (e.g., jugular, subclavian; femoral vein) that is anticipated to remain in the subject for the treatment portion of the study. > 12 to <18 years of age Exclusion Criteria: Current or recent (within 3 months of study drug administration) gastrointestinal disease or gastrointestinal surgery that, in the opinion of the investigator and the BMS Medical Monitor, could impact the absorption of the study drug Active bleeding or high risk of bleeding

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 5A - Apixaban (Low Dose)<br>Group 5: 12 years to <18 years; 0.66 mg/m² Oral solution, Oral, Twice A Day (BID), 10 days | Drug: Apixaban<br> <br> * Other names: BMS-562247;|
| Experimental: Group 5B - Apixaban (High Dose)<br>Group 5: 12 years to <18 years; 1.32 mg/m² Oral solution, Oral, Twice A Day (BID), 10 days | Drug: Apixaban<br> <br> * Other names: BMS-562247;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic (PK): Model-derived population & individual PK parameters (e.g., CL/F, Vc/F, KA) used to estimate steady state Cmax & AUC(TAU), Cmin & Tmax in each subject. Population PK model will be developed using plasma concentration vs time data |  | Days 1, 2, Day 5, 6 or 7 and Day 11 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of anti-Factor Xa confirmed by analysis of anti-Factor Xa PD analysis |  | Days 1, 2, Day 5, 6 or 7 |
Parents' Knowledge Toward Pediatric Dentistry

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to assess the Parents' Knowledge, Attitudes &Awareness toward Pediatric Dentistry.

Detailed Description
-----------------
Primary teeth are the valuable assets of a child. In children, milk teeth/primary teeth play a vital role for eating, phonetics and esthetics. Primary teeth are also essential in the development of the mouth. They maintain the arch length within the jaw and provide guides for the eruption pathway of the permanent teeth. Problems in primary teeth in the form of pain and swelling can cause distress to the child, leading to inability to chew or speak properly and even may affect the appearance of a child. Premature loss of primary teeth can cause an earlier eruption of permanent successors and interfere with the harmony of adult dentition resulting in crowding caused by shifting and or drifting of the teeth toward the extraction space. Moreover, psychological, morphological and functional problems may result from premature loss of primary teeth. Most parents are unaware of the role a pediatric dentist plays in their child's life, and the importance of dental visits at an early age is underestimated as most believe that the milk teeth are going to exfoliate and it not worth paying much attention to. Even if a parent is recommended to take the child to a pediatric dentist, many may not consider doing the same since awareness of importance of primary teeth is less.

Official Title
-----------------
Parents' Knowledge, Attitudes &Awareness Toward Pediatric Dentistry

Conditions
-----------------
Parents' Knowledge

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parents of children aged 3 years- 12 years. Children with no previous dental treatment. Healthy children without any systemic diseases. Exclusion Criteria: Refusal of participations.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parents' Knowledge, Attitudes &Awareness toward Pediatric Dentistry | Data will be collected through a questionnaire for assessing parent's knowledge, attitudes &awareness toward pediatric dentistry. | after 3 months |
To Yield Further Information On The Efficacy And Safety Of Viagra Among Subjects With Arterial Hypertension .

Study Overview
=================
Brief Summary
-----------------
To assess changes with respect to Erectile Dysfunction in subjects treated with Viagra and antihypertensive therapy.

Official Title
-----------------
Open Label, Multicenter, Non Comparative Study, To Confirm The Efficacy And Tolerability Of Viagra In Subjects With Erectile Dysfunction And Arterial Hypertension Who Are Taking Antihypertensive Treatment.

Conditions
-----------------
Impotence, Hypertension

Intervention / Treatment
-----------------
* Drug: Sildenafil Citrate


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Subjects with arterial hypertension treated with one or more antihypertensive agents, the doses of which have been stable for at least 4 weeks prior to the baseline visit, with a documented clinical diagnosis of ED and a confirmation of this by a qualification of 21 or less on the SHI-M. Exclusion Criteria: Subjects with resting sitting systolic blood pressure >170 or <110mmHg or resting sitting diastolic blood pressure >90 or <50mmHg, with significant cardiovascular disease and retinitis pigmentosa, treatment with nitrates, alfablockers or CYP3A4 inhibitors.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sildenafil Citrate|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy measure is the percent of ITT subjects at week 8 with positive response to the Global Efficacy Assessment question regarding the effectiveness of the medication in improving erections over no treatment at all for ED. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The evaluation of change from baseline to week 8 on the toal SHI-M (Sexual Health Inventory-Male) score and the 5 individual items on the SHI-M. Global Efficacy Assessment Questions 2 and 3 at week 8. |  |  |
A Two-week Study Assessing the Onset of Effect Questionnaire Administered Pre-dose Versus Post-dose in Adult Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate whether subjects respond similarly to the Onset of Effect Questionnaire (OEQ) administered pre-dose versus post-dose, while receiving SYMBICORT® pMDI 80/4.5 μg x 2 actuations twice daily or budesonide HFA pMDI 80 μg x 2 actuations twice daily.

Official Title
-----------------
A Two-week, Randomised, Double-blind Study Assessing the Onset of Effect Questionnaire Administered Pre-dose Versus Post-dose in Adult Subjects (≥ 18 Years) With Mild to Moderate Asthma, Receiving SYMBICORT® pMDI 80/4.5 μg x 2 Actuations Twice Daily or Budesonide HFA pMDI 80 μg x 2 Act. Twice Daily

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Budesonide/formoterol pMDI
* Drug: Budesonide HFA pMDI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female, > 18 years of age Mild to moderate asthma requiring treatment with an inhaled corticosteroid Diagnosis of asthma for at least 6 months Exclusion Criteria: Subjects requiring treatment with systemic corticosteroids (e.g., oral, parenteral, ocular) Subjects with severe asthma, as judged by investigator Any significant disease or disorder that may jeopardize a subject's safety

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Budesonide/formoterol pMDI|nan|
|Drug: Budesonide HFA pMDI|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine whether subjects respond similarly to the Onset of Effect Questionnaire items 2 and 5 when administered post-dose versus pre-dose and does that difference favour a bronchodilator treatment group over a non-bronchodilator treatment group |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if there is an association between the immediate physiological response to medication and the responses to OEQ items 2 and 5 and to determine what subjects mean when they say they feel their asthma maintenance medication 'working right away |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mild Asthma, Moderate Asthma