linjc16/ctgov huggingface dataset:
Impact of Fluoride Vanish Application in Dental Prevention for Elderly

Study Overview
=================
Brief Summary
-----------------
This study questions the interest of fluoride varnish dental application in preventing tooth decay in a population of institutionalised elderly people.

Detailed Description
-----------------
Application of fluoride varnish on one side of the mandibles (left or right, randomly selected) in a population of institutionalised elderly people.

Official Title
-----------------
Evaluation of the Impact of Fluoride Vanish Application in Dental Prevention Among Institutionalised Elderly People

Conditions
-----------------
Tooth Decay

Intervention / Treatment
-----------------
* Drug: Duraphat


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient hospitalised in nursing home or long-stay hospital department patient older than 18 years old obtention of informed consent 3 or more healthy or treated teeth on each side (left and right) of the mandibles Exclusion Criteria: patient in palliative care or end-of-life care patient without social security affiliation patient participating in another research dealing with dental care contra-indication to fluoride varnish

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: fluoride varnish<br>Duraphat: Application of fluoride varnish on one side of the mandibles (left or right, randomly selected) | Drug: Duraphat<br>* After prophylactic cleaning of the mouth and teeth, application of fluoride varnish according to the manufacturer's recommendations (up to 0.75 ml per application)<br>|
| No Intervention: control<br>no application on the other side | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of tooth decay at endpoint. Comparison, between the treated and not treated side of the mandibles |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tooth-decay, prevention, fluoride-varnish, institutionalised elderly people
New Mechatronic Device for Epidural Space Detection

Study Overview
=================
Brief Summary
-----------------
This study sought to perform the feasibility assessment of a new, non-invasive device for Loss of Resistance (LOR) detection in clinical settings. The device in charge is a mechatronic device optimized in its configurations in order to detect Loss of Resistance while performing epidural injections.

Official Title
-----------------
A New Pressure Guided Mechatronic Tool for Epidural Space Detection: Feasibility Assessment in a Clinical Scenario

Conditions
-----------------
Non Invasive Monitoring of Loss of Resistance During Epidural Injection

Intervention / Treatment
-----------------
* Device: LOR measurement via device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients whose pathology requires specific treatment such as epidural infiltration Exclusion Criteria: coagulation abnormalities or assumption of anticoagulant drugs
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Procedures with the use of device for LOR monitoring<br>Patients enrolled suffered from chronic back pain and underwent epidural infiltration. The device is used. | Device: LOR measurement via device<br>* The epidural technique is totally performed in a sterile field without any harm to the patient. The LOR measurement is monitored via the bespoke device used during the epidural procedure.<br>|
| No Intervention: Procedures without the use of device for LOR monitoring<br>Patients enrolled suffered from chronic back pain and underwent epidural infiltration | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Loss of resistance detection | A non invasive device to detect loss of resistance during epidural infiltration | throughout the epidural infiltration procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Epidural injection, loss of resistance detection, mechatronic device
Heparin-induced Thrombocytopenia (HIT II) in Liver Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
In a prospective observational study the incidence of Heparin-induced Thrombocytopenia (HIT) Type 2 after orthotopic liver transplantation, associated factors, and hemostaseological findings in thrombocytes and anti-body patterns is going to be investigated.

Detailed Description
-----------------
The investigators examined the frequency of anti-PF4/heparin antibodies (IgG/M/A; EIA) and their functional activity (HIPA) in 38 whole organ deceased donor liver transplant recipients. Additionally, demographic, clinical, donor- and recipient-specific parameters and laboratory findings (ALAT, ASAT, cholinesterase) were investigated.

Official Title
-----------------
Heparin-induced Thrombocytopenia (HIT II) in Liver Transplant Recipients: a Prospective Multivariate Analysis of Prognostic Factors and Haemostaseological Findings

Conditions
-----------------
Heparin-induced Thrombocytopenia, Liver Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all consecutive liver transplant recipients between 01/2010 and 08/2011 who were transplanted at our center after allocation of a liver graft via Eurotransplant Exclusion Criteria: patient's refusal to participate in prospective observation

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| orthotopic Liver Transplantation<br>consecutive inclusion of all recipients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
liver transplantation, thrombocytes, heparin-induced thrombocytopenia, multivariate analysis of associated factors of HIT 2 after OLT, laboratory investigations of HIT-antibodies
Predictive Factors of Intestinal Infraction in Acute Mesenteric Ischemia

Study Overview
=================
Brief Summary
-----------------
The study aims to identify several factors that can accurately predict the incident of intestinal infraction in patients with mesenteric vascular occlusion or ischemia.

Detailed Description
-----------------
The study aims to identify several clinical, laboratory, and radiologic factors that can accurately predict the occurrence of intestinal infraction in patients with mesenteric vascular occlusion or ischemia in order to prevent unnecessary surgical intervention in patients with just intestinal ischemia and to hasten intervention in patients with actual intestinal gangrene.

Official Title
-----------------
Predictive Factors of Intestinal Infraction in Patients With Acute Mesenteric Ischemia

Conditions
-----------------
Mesenteric Ischemia

Intervention / Treatment
-----------------
* Drug: Heparin injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with acute mesenteric Ischemia Exclusion Criteria: Patients with other causes of acute abdomen other than mesenteric Ischemia

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heparin injection<br>Injection of low molecular weight heparin in patients with acute mesenteric ischemia to assess outcome | Drug: Heparin injection<br>* Intravenous heparin injection in patients with acute mesenteric ischemia and evaluating their response within 24 hours<br>* Other names: Low molecular weight heparin injection;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement | Number of patients with resolved abdominal symptoms and incidence of patients developing shock | 48 hours |
Spanish Registry on Spontaneous Coronary Artery Dissection

Study Overview
=================
Brief Summary
-----------------
Multicenter observational prospective registry, Spanish nationwide-based, of consecutive patients diagnosed with Spontaneous Coronary Artery Dissection (SCAD)

Detailed Description
-----------------
Multicenter prospective registry on patients with diagnosis of Spontaneous Coronary Artery Dissection (SCAD). Spanish nationwide based, the aims of the current registry are: To analyze predisposing factors, potential triggers and associated pathologies of patients presenting with SCAD. To study the clinical and angiographic presentation of these patients. To analyze the value of intracoronary diagnostic techniques (OCT, IVUS) and non-invasive imaging techniques in the diagnosis of this pathology. To better understand the in-hospital clinical evolution and the response to medical treatment or revascularization in these challenging patients, taking into account the angiographic or intravascular imaging morphological characteristics of SCAD and the treatment applied. To analyze its long-term clinical evolution (adverse cardiovascular events, including recurrence of SCAD). To identify those factors directly related to prognostic and risk of recurrence.

Official Title
-----------------
Spanish Registry on Spontaneous Coronary Artery Dissection

Conditions
-----------------
Spontaneous Coronary Artery Dissection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Those consecutive patients with a novel diagnosis of Spontaneous Coronary Artery Dissection (SCAD) that, after careful information, accepted to sign the informed consent form. Exclusion Criteria: Those patients unable to provide informed consent.
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 |
| --- | --- | --- |
| Predictors of adverse events | Clinical, angiographic and imaging predictors of adverse events during follow-up | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictors of recurrences | Predictors of recurrences of SCAD at follow-up | 3 years |
Reinforcing Effects of Marijuana and Opioids

Study Overview
=================
Brief Summary
-----------------
The primary goals of this study are to examine 1) marijuana modulation of oxycodone self-administration and 2) oxycodone modulation of marijuana self-administration, under controlled conditions and across a range of doses for each drug.

Official Title
-----------------
Modulation of Drug Intake: Evaluation of Opioid and Cannabinoid Interactions on Drug Self-Administration

Conditions
-----------------
Marijuana Use, Opioid Use

Intervention / Treatment
-----------------
* Drug: Marijuana
* Drug: Opioid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 18-50 Experience with marijuana and opioids General good health Willing to live at the University of Kentucky Hospital (research unit) for approx. 6.5 weeks (meals are provided, Exclusion Criteria: Significant medical complications/conditions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Double-blind marijuana/placebo administration<br>Participants will receive double-blind administration of vaporized marijuana/placebo | Drug: Marijuana<br>* Double-blind administration of marijuana<br>* Other names: Cannabis;Drug: Opioid<br>* Double-blind administration of an opioid agonist<br>|
| Experimental: Double-blind opioid/placebo administration<br>Participants will receive double-blind administration of intranasal opioid agonist/placebo | Drug: Marijuana<br>* Double-blind administration of marijuana<br>* Other names: Cannabis;Drug: Opioid<br>* Double-blind administration of an opioid agonist<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-Administration | The number of units of drug earned in each session | Collected once during each self-administration session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective measures | Ratings of drug effects (e.g., feeling high, impaired, good drug effects) | Baseline, post-dose during each session (change from baseline is assessed); visual analog scales will be the primary measure (0-100, 0=not at all, 100=extremely) | 
| Heart rate | Beats per minute | Baseline, post-dose during each session (change from baseline is assessed) | 
| Blood pressure | Systolic and diastolic blood pressure (mm/hg) | Baseline, post-dose during each session (change from baseline is assessed) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
marijuana, opioid, healthy participants, laboratory study
Duloxetine on Bone Metabolism

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to determine the effect of duloxetine as monotherapy on biochemical markers and bone mineral density.

Detailed Description
-----------------
51 patients diagnosed with chronic pain or fibromyalgia syndrome who were using duloxetine for at least 3 months and age and sex matched 51 healthy individuals were recruited for this cross-sectional study. Bone mineral density of both groups were measured by dual energy x ray absorbsiometry(DXA), bone biochemical markers, serum calcium, and vitamin D levels were investigated.

Official Title
-----------------
The Effect of Duloxetine on Bone Metabolism

Conditions
-----------------
Chronic Pain, Fibromyalgia

Intervention / Treatment
-----------------
* Drug: Duloxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 years or <50 years patients using duloxetine for at least 3 months due to chronic pain or fibromyalgia Exclusion Criteria: postmenopausal women clinical conditions which cause secondary osteoporosis patients using medication that cause secondary osteoporosis pregnancy and malignity

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| Duloxetine Group<br>Patients who use duloxetine at least 3 months for chronic pain or fibromyalgia | Drug: Duloxetine<br>* Patients who use duloxetine for chronic pain or fibromyalgia<br>|
| Healthy Group<br>Age and sex matched 51 healthy individuals | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DXA | Bone mineral densitomtry | 3 months | 
| CTX | C-terminal telopeptide | 3 months | 
| OC | Osteocalcin | 3 months | 
| 25-OH VITD3 | 25-hydroxyvitamin D3 | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
duloxetine, chronic pain, fibromyalgia, bone metabolism
Presepsin as Detective Marker of Sepsis in Immunodeficiency ICU Patients

Study Overview
=================
Brief Summary
-----------------
This is an observational study to evaluate the diagnostic and prognostic value of presepsin in the critically-ill immunocompromise patients.

Official Title
-----------------
Study of Usefulness of Presepsin as Early Detective Marker of Sepsis in Immunodeficiency ICU Patients

Conditions
-----------------
Sepsis, Immune Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged ≥ 19 years Appropriate clinical data to enable classification into sepsis Written informed consent by the patient or legally authorized representative Critical illness consistent with sepsis, to be enrolled within 24 hours of presentation Exclusion Criteria: No informed consent A patient who is judged to be unable to make a voluntary decision by understanding information about this research due to cognitive vulnerability

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Immunocompetent sepsis patients<br>Sepsis patients without HIV infection (all stages), neutropenia (neutrophil count < 1 × 109/L), exposure to glucocorticoids (> 0.5 mg/kg for > 30 d) and/or immunosuppressive or cytotoxic medications, solid organ transplantation, allogeneic or autologous stem cell transplantation, hematological malignancy, or solid tumor. | |
| Immunocompromised sepsis patients<br>Sepsis patients with HIV infection (all stages), neutropenia (neutrophil count < 1 × 109/L), exposure to glucocorticoids (> 0.5 mg/kg for > 30 d) and/or immunosuppressive or cytotoxic medications, solid organ transplantation, allogeneic or autologous stem cell transplantation, hematological malignancy, or solid tumor. | |
| Patients without sepsis<br>Patients who admitted intensive care unit without sepsis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Receiver Operating Characteristic Curve (ROC-AUC) of the Plasma Presepsin Concentration for Discriminating Between immunocompetent and immunocompromised patients. | For the analysis, plasma presepsin levels on Day 0 will be used. Sepsis was made on Day 7 or day of discharge. ROC-AUC of presepsin for discriminating between immunocompromised and immunocompetent patients is compared to that of procalcitonin. | up to 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival at ICU discharge or day 28 after enrollment | For the analysis, we will evaluate the association between presepsin and survival at ICU discharge or day 28 after enrollment | 28 days |
Cognitive Dysfunction After Aneurysmal Subarachnoid Haemorrhage

Study Overview
=================
Brief Summary
-----------------
This is a longitudinal, multi-center, prospective study of aneurysmal subarachnoid haemorrhage patients in neurosurgical units in Hong Kong.

Detailed Description
-----------------
The investigators aim to recruit a total of 240 aneurysmal subarachnoid haemorrhage patients. The schedule for neuropsychological and functional assessments will be phased in at the second to third week, the third month, and the twelve months after the initial haemorrhage.

Official Title
-----------------
Cognitive Dysfunction After Aneurysmal Subarachnoid Haemorrhage

Conditions
-----------------
Cognitive Dysfunction

Intervention / Treatment
-----------------
* Other: Cognitive assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Spontaneous subarachnoid haemorrhage with intracranial aneurysms as aetiology Admission within 96 hours of ictus Aged between 21 and 75 years A speaker of Chinese (Mandarin or Cantonese) Informed consent from patients or their legally acceptable representatives Exclusion criteria History of previous cerebrovascular disease or neurological disease other than intracranial aneurysm History of neurosurgical operation prior to ictus

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 75 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 |
| --- | --- |
| aSAH patients<br>Cognitive assessment | Other: Cognitive assessment<br>* Cognitive and functional assessments at 2-4 weeks, 3 months and 12 months.<br>* Other names: Cognition;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive dysfunction | Montreal Cognitive Assessment | 3 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurological Outcome | Modified Rankin Scale | 3 and 12 months | 
| Generic Quality of Life | ShortForm36(SF-36) | 3 and 12 months | 
| Activity of Daily Living | Barthel Index | 3 and 12 months | 
| Disease-specific Quality of Life | Stroke-specific-QOL | 3 and 12 months | 
| Functional Outcome | Functional Independent Measure (FIM) | 3 and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cognition, subarachnoid hemorrhage.