linjc16/ctgov huggingface dataset:
Clinical Performance Evaluation of Two Different Dental Implants

Study Overview
=================
Brief Summary
-----------------
In brief, the aim of this randomized controlled trial is to evaluate the patient satisfaction and the clinical performance of two types of implants: 1) HA-coated hybrid dental implant and 2) non-coated moderately rough dental implant. The comparison will be studied during a routine implant placement of experienced dental implantologists.

Official Title
-----------------
Clinical Performance Evaluation of a Hyaluronic Acid-coated Hybrid Dental Implant Compared to a Non-Coated Standard Rough Dental Implant: A Pragmatic Multi-center Randomized Controlled Trial

Conditions
-----------------
Edentulism

Intervention / Treatment
-----------------
* Device: dental implant-supported restoration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent to participate to the present investigation Psychological appropriateness and good compliance to dentist instructions Patient who have been selected for implant therapy by an experienced surgeon.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HA-coated hybrid implant<br>Patient allocated to this group will receive an iMAX® Hyaluronic Acid-coated hybrid dental implant for their dental implant-supported restoration. | Device: dental implant-supported restoration<br>* During the oral surgery session for dental implant insertion, after implant site preparation, the opaque sealed envelope containing the patient allocation will be opened. Following the group allocation, the patient will receive either an HA-coated Hybrid or moderately rough dental implant<br>|
| Active Comparator: Moderately rough implant<br>Patient allocated in this group will receive an iMAX® non-coated moderately rough dental implant with a machined neck their dental implant-supported restoration. | Device: dental implant-supported restoration<br>* During the oral surgery session for dental implant insertion, after implant site preparation, the opaque sealed envelope containing the patient allocation will be opened. Following the group allocation, the patient will receive either an HA-coated Hybrid or moderately rough dental implant<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival Rate | Cumulative implant survival rate | 12 months after implant placement |
Central and Peripheral Arterial Pressure Decoupling In Cardio-Pulmonary Bypass

Study Overview
=================
Brief Summary
-----------------
Central and peripheral arterial pressure decoupling occurs in some clinical conditions like sepsis or cardiopulmonary bypass. This decoupling may leed to unsuitable decisions such as the use of catecholamines. The aim of this study is to evaluate the pulse wave's speed as a marker of central and peripheral arterial pressure decoupling in a scheduled condition which is the cardiopulmonary bypass during cardiac surgery.

Official Title
-----------------
Central and Peripheral Arterial Pressure Decoupling In Cardio-Pulmonary Bypass

Conditions
-----------------
Cardiopulmonary Bypass, Cardiac Surgery, Extracorporeal Circulation

Intervention / Treatment
-----------------
* Procedure: Non-invasive blood pressure oscillometer (NIBP) implementation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled patient for coronary or valvular surgery with cardiopulmonary bypass Cardiopulmonary bypass is at least 90 minutes Written consent is needed Exclusion Criteria: Patient with heart rate disorder Patient with aortic dissection Dobutamine/milrinone/levosimendan treatment before surgery Patient with heart rate due to a pacemaker

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Pulse wave's speed observational arm<br>Whole patients for who the pulse wave's speed are measured during a cardiopulmonary bypass during cardiac surgery | Procedure: Non-invasive blood pressure oscillometer (NIBP) implementation<br>* Implementation of two additional NIBP on humeral and femoral sites.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of femoral, radial and humeral pulses during a cardiopulmonary by-pass (CPBP). | Pulse wave's speed is calculated using 1) time between ECG R-wave and local detection of the pulse wave (femoral, humeral and radial) 2) a length from heart to these sites. Wave detection at femoral and humeral sites will use oscillometry and wave detection at radial site will use an invasive catheter which is always set for this surgery. | Day one (6 times) |
Myofascial Induction Effects on Plantar Pressures and Stabilometry

Study Overview
=================
Brief Summary
-----------------
The objective is to determine the effectiveness of myofascial Induction effects on plantar pressures and stabilometry variables. Forty healthy subjects (28 females and 12 males) will be recruited for a simple blind clinical trial. All subjects will be randomly distributed in two different groups: control group (sham treatment of myofascial Induction) and experimental group (myofascial Induction). Outcome measurements will be foot plantar pressure area (footprint) and center of pressure area (stabilometry) by the Balance Evaluation Systems test. Two trials will be recorded for each condition.

Official Title
-----------------
Myofascial Induction Effects on Plantar Pressures and Stabilometry Variables. A Clinical Trial

Conditions
-----------------
Foot Diseases, Myofascial Pain

Intervention / Treatment
-----------------
* Other: Myofascial induction
* Other: Sham myofascial induction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy individuals without pain. Exclusion Criteria: Previous lower extremities surgery History of lower extremities injury with residual symptoms within the last year Evidence of a leg-length discrepancy of more than 1 cm Evidence of balance deficits

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Myofascial induction | Other: Myofascial induction<br>* Myofascial induction in plantar fascia<br>|
| Sham Comparator: Control group<br>Sham myofascial induction | Other: Sham myofascial induction<br>* Sham myofascial induction in plantar fascia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Foot plantar pressure area | Foot plantar pressure area measured by the Balance Evaluation Systems test (squared centimeters) | Change from foot plantar pressure area at 2 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Center of pressure area | Center of pressure area measured by the Balance Evaluation Systems test (squared centimeters) | Change from center of pressure area at 2 minutes |
Olfactory Dysfunction of Rhinosinusitis - Cyclic Adenosine Monophosphate (cAMP)/Calcium Signaling Study

Study Overview
=================
Brief Summary
-----------------
The study examines the biochemistry underlying human olfaction in both normal and diseased states. The study aims are: 1. to determine the levels of cAMP in olfactory tissue from people with chronic rhinosinusitis and other nasal disorders. 2. to correlate preoperative olfactory function with cAMP levels from biopsied olfactory tissue. 3. to determine odorant and pheromone-mediated activation of cultured human olfactory sensory neurons using calcium imaging and 4. to determine odorant and pheromone-mediated activation of cultured human olfactory sensory neurons using smell-chip technology.

Detailed Description
-----------------
Subject will be recruited from those scheduled to have endoscopic sinus surgery and similar procedures. This study uses the tissue that would normally be discarded during the surgical process. The tissue is cultured and frozen for purposes of the following testing: odor detection and signal transduction, cyclic adenosine monophosphate and odor detection, the role of cAMP in olfactory dysfunction, and pheromone detection. Only tissue that would normally be discarded during the course of the surgery will be used. The study does not interfere with or change any clinical care.

Official Title
-----------------
Olfactory Dysfunction of Rhinosinusitis - cAMP/Calcium Signaling Study

Conditions
-----------------
Sinusitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects will be 18 years old and over and scheduled for one of the following: endoscopic sinus surgery for chronic sinusitis endoscopic transnasal approach to the pituitary for pituitary tumor removal endoscopic inferior turbinectomy or septoplasty for nasal congestion endoscopic repair of cerebrospinal fluid (CSF) leaks Exclusion Criteria: Subjects are excluded if they are unable to give informed consent or unable to complete self-administered questionnaires due to English language barrier, cognitive impairment, or severe medical conditions

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sinusitis
Acetyl-L-Carnitine Supplementation During HCV Therapy With Pegylated Interferon-α2b Plus Ribavirin

Study Overview
=================
Brief Summary
-----------------
To assess the effects of Acetyl-L-Carnitine administration on work productivity, daily activity, and fatigue in subjects with chronic hepatitis C treated with Pegylated-Interferon-α2b and Ribavirin.

Conditions
-----------------
Work Productivity and Activity Impairment in Workers With Chronic C Hepatitis, Fatigue in Workers With Chronic C Hepatitis, Fatigue

Intervention / Treatment
-----------------
* Drug: Acetylcarnitine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: workers who were 18 years of age or older Workers who were infected by HCV and had a quantifiable serum HCV RNA level (as determined by polimerase chain reaction, COBAS AmpliPrep/COBAS TaqMan - ROCHE) Cirrhotic workers with a Child-Pugh score less than 7 Exclusion Criteria: workers who had other liver diseases cancer severe jaundice pulmonary and renal chronic diseases, prostatic diseases autoimmune diseases diabetes mellitus decompensated cirrhosis pregnancy cardiopathy hemoglobinopathies hemocromatosis major depression severe psychiatric pathological conditions

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acetyl-L-carnitine<br>2 g daily for 12 months | Drug: Acetylcarnitine<br> <br> |
| Placebo Comparator: placebo<br> | Drug: Placebo<br>* (sugar pill)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Work Productivity and Activity Impairment in workers with chronic hepatitis C | Work productivity loss, impairment in daily activities, presenteeism, absenteeism, will be assessed using the Work Productivity and Activity Impairment questionnaire. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue in workers with chronic hepatitis C | Severity of fatigue, mental fatigue and physical fatigue. | 12 months |
Confocal Reflectance Microscopy of Shave-Biopsy Sites on Skin in Vivo.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate a new instrument that shines light and takes digital pictures of skin. The goal is to develop a technique that may enable fast and accurate detection of skin disorders and cancers for future clinical diagnosis and surgical use.

Official Title
-----------------
Confocal Reflectance Microscopy of Shave-Biopsy Sites on Skin in Vivo

Conditions
-----------------
Basal Cell Carcinoma, Melanoma, Squamous Cell Carcinoma, Non-Malignant Skin Disorders

Intervention / Treatment
-----------------
* Procedure: confocal microscopy in vivo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing shave-biopsy on an anatomical site that is readily accessible to the VivaScope 1500 (for example, chest, back, legs, arms, cheek, forehead). The additional 110 patients for this amendment will be imaged with the newly developed Vivascope 3000 handheld confocal microscope. Ability to sign informed consent. Age ≥ 18 years. Exclusion Criteria: Shave-biopsy located on a site that is not amenable to confocal imaging (for example, adjacent to the nose, ears or eyes, fingers, toes). Inability to give informed consent. Known hypersensitivity to adhesive rings. Inability to tolerate imaging procedure (i. e., remain relatively still for multiple short durations of 3-4 minutes).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| 1<br>Patients undergoing a shave biopsy and confocal microscopy. | Procedure: confocal microscopy in vivo<br>* A dermatologist will perform a shave biopsy according to standard clinical procedures. This study will be carried out after the shave biopsy. The deep surface and the peripheral margins will be imaged on each patient.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| is to evaluate and quantify the technical feasibility of reflectance CSLM imaging of shave-biopsy sites on skin in vivo. |  | conclusion of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the quality of the CSLM images of the biopsy sites to determine a point estimate of the proportion of images that will be of acceptable quality for formal analysis in the planned study of intraoperative margin detection. |  | conclusion of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
06-009, Confocal reflectance microscopy, shave-biopsy
Prevalence of Sleep Disordered Breathing in a Lung Cancer Screening Cohort

Study Overview
=================
Brief Summary
-----------------
Prospective study of sleep disordered breathing in a lung cancer screening cohort.

Detailed Description
-----------------
The proposed study is a prospective single arm study evaluating the prevalence of sleep disordered breathing in a cohort of lung cancer screening patients.

Official Title
-----------------
Prevalence of Sleep Apnea in a Lung Cancer Screening Cohort Meeting NLST Criteria

Conditions
-----------------
COPD, Sleep Apnea Hypopnea Syndrome, Emphysema, Lung Cancer

Intervention / Treatment
-----------------
* Other: poligraphy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 55-75. > 30 pack years tobacco exposure. Enrolled in lung cancer screening program. Exclusion Criteria: Inability or unwillingness to undergo a home sleep study.

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic<br>Patients enrolled in lung cancer screening subjected to a sleep study. | Other: poligraphy<br>* Sleep study<br>|
| No Intervention: Contro<br>Patients enrolled in lung cancer screening not included in the diagnostic intervention arm | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of sleep apnea |  | 1 year |
Research of Biomarkers in Duchenne Muscular Dystrophy Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify potential biomarkers for the diagnosis, disease progression assessment and response to treatment in patients with Duchenne Muscular Dystrophy.

Official Title
-----------------
Research of Biomarkers for Disease Diagnosis, Disease Monitoring and Therapeutic Treatment Response in Duchenne Muscular Dystrophy Patients

Conditions
-----------------
Duchenne Muscular Dystrophy (DMD)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: FOR PATIENTS: Diagnosis of DMD confirmed by genetic testing Age over 3 years Weight over 15 kg Informed consent signed FOR CONTROLS: Age over 3 years Male gender Weight over 15 kg Subjects with national health insurance coverage Informed consent signed Nonacute or chronic muscular, allergic, infectious, endocrine or inflammatory disorder in the 3 weeks preceding inclusion Exclusion Criteria: FOR PATIENTS: Concomitant chronic or acute muscular, endocrine, infectious, allergic or inflammatory disorder in the three weeks preceding the blood test Intake of medicines other than angiotensin-converting enzyme inhibitors, beta blockers, dietary supplements, vitamins, alendronate and methylphenidate. Steroids (and medicines prescribed with them such as calcium supplements and proton pump inhibitors) will be discussed Mental retardation or autism Vaccination or treatment with immunoglobulins within the three months preceding inclusion FOR CONTROLS: Concomitant chronic or acute muscular, neurological (including mental retardation and autism), infectious or inflammatory disorder in the three weeks preceding the blood test Vaccination or treatment with immunoglobulins within the three months preceding inclusion

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 20 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DMD patients<br>DMD Patients | |
| Control patients<br>Control patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IBiSD aims to identify and validate new and disease-specific biomarkers. | This study will establish the relevance of urinary and blood biomarkers for the diagnosis, follow-up and assessment of treatment response in patients with DMD (IBiSD1, 2 and 4). IBiSD will also attempt to establish the seroprevalence to the different strains of AAV in patients with DMD (IBiSD3). | End of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Duchenne Muscular Dystrophy, biomarkers, transcriptomics, mironics, proteomics