linjc16/ctgov huggingface dataset:
A Split-Blind Clinical Investigation to Compare the Performance and Safety of Inion GTR™ Biodegradable Membrane System to Resorbable Bilayer Bio-Gide®-Membrane of Geistlich Biomaterials in Enhancing Bone Regeneration After Removal of Wisdom Teeth.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to evaluate by histology and histomorphometry, thirty human osseous biopsies sampled from fifteen patients (2 biopsies per patient) following 3 months of implantation. This study is part of a splitting-blind clinical investigation to compare the performance and safety of INION GTRTM Biodegradable Membrane System to resorbable bilayer Bio-Gide®-membrane of Geistlich biomaterials in enhancing bone regeneration after removal of wisdom teeth. The bone defect and alveolar cavity were augmented with Spongostan® dental 1x1x1cm, Johnson & Johnson, Spreitenbach, Switzerland. The extraction sites were covered on one side with an INION GTRTM Biodegradable Membrane System and on the other with Geistlich resorbable bilayer Bio-Gide®-membrane. This study was conducted in adaptation to the ISO 10993 Standard : Biological Evaluation of Medical Devices, Part 6 (2007): Tests for Local Effects after Implantation. This study was conducted in accordance with the requirements of the FDA (Department of health and human services) Good Laboratory Practice (GLP) Regulations, 21 CFR 58 (revised as of April 01, 2005) and in accordance with the requirements of the OECD Good Laboratory Practices, reference ENV/MC/CHEM (98) 17, adapted by council on November 26th 1997. Trial with medical device

Conditions
-----------------
Bone Regeneration Following Wisdom Teeth Extraction

Intervention / Treatment
-----------------
* Device: guided bone regeneration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Females or males between the age of 18 to 30 Subject for extraction of both lower fully impacted wisdom teeth Signed informed consent Able and willing to comply with all study procedures Exclusion criteria: Heavy smoker (>20/day) Insulin dependant diabetes Pregnant or nursing

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: guided bone regeneration|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Study Evaluating GAP-486 in Heart Rhythm

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn the effects of a test drug on heart rhythm, and to provide additional data to see if the test drug is well tolerated and safe.

Official Title
-----------------
A Study to Characterize the Acute Electrophysiologic Properties, Safety and Tolerability of GAP-486

Conditions
-----------------
Arrhythmia

Intervention / Treatment
-----------------
* Drug: GAP-486 (ZP-123)
* Drug: 0.9% Sodium Chloride, USP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing an electrophysiology study for evaluation of heart rhythm. Exclusion Criteria: Patients with uncontrolled blood pressure Patients with certain cardiac risk factors Patients with significant kidney or liver problems

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GAP-486 (ZP-123)|nan|
|Drug: 0.9% Sodium Chloride, USP|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| This study takes place within 24 hours. The measure to determine the effect of the intervention will be the difference in values from the baseline electrophysiology study, and the values obtained after intervention within the test drug. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| This study takes place within 24 hours, and looks at the changes in values of electrophysiology studies, before and after administration of test article. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arrhythmia, syncope, antiarrhythmic
The Biomarker and Cardiac Function in Sepsis

Study Overview
=================
Brief Summary
-----------------
The development and severity of sepsis induced myocardial dysfunction can be monitored from the serum biomarker.

Official Title
-----------------
The Biomarker and Associated Cardiac Function in the Patients With Sepsis

Conditions
-----------------
Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sepsis patients with 2 of the followings when arrival ER and treated > 6 hours: BT >38℃ or<36℃ HR >90/min RR >20/min or PaCO2 < 32 mmHg WBC count >12×109/L or <4×109/L or immature form >10％ Exclusion Criteria: Age < 18 Major trauma patients Pregnancy Willing to do not aggressive treatment

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 |
| --- | --- | --- |
A Survey on Consumer Use of Over-the-Counter (OTC) Nicotine Patches

Study Overview
=================
Brief Summary
-----------------
Since 1996, the nicotine patch has been re-classified from prescription to over-the-counter (OTC) status in the United States. Little is known about how the public uses the OTC nicotine patch due to lack of monitoring. The purpose of this observational study is to describe the characteristics of consumers who purchase OTC nicotine patches from community pharmacies and to determine the factors associated with the appropriate use of nicotine patches.

Detailed Description
-----------------
The nicotine patch is an effective aid for smoking cessation. Since 1996, the nicotine patch has been re-classified from prescription to over-the-counter (OTC) status in the United States. Unlike prescription medications, post-marketing surveillance does not exist for OTC medications. The purpose of this study is to describe the characteristics of consumers who purchase OTC nicotine patches from community pharmacies and to determine the factors associated with appropriate use of nicotine patches. This prospective, cross-sectional, observational study will include a survey of 600 consumers who purchase OTC nicotine patches at a random sample of 30 community retail pharmacies. Consumers will be recruited by an ad located in the pharmacy next to the nicotine patch product. Participants will fill out a self-administered, anonymous questionnaire at the time of OTC nicotine patch purchase at the pharmacy counter. The questionnaire will gather information about demographics, medical history, smoking history, attitudes toward the nicotine patch, and motivation to quit smoking. No study visits will be required for this study.

Official Title
-----------------
Usage Patterns of OTC Nicotine Patches: Consumer Survey

Conditions
-----------------
Nicotine Dependence, Tobacco Use Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Purchased OTC nicotine patch (NicoDerm CQ Step I, II, III or Sav-on Nicotine Patch) for personal use Exclusion Criteria: Purchased OTC nicotine patch for someone other than self (e.g., friend or family member)

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Noninvasive Perioperative Monitoring of Arterial Stiffness, Volume and Nutritional Status in Stable Renal Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
Central blood pressure and pulse wave velocity were measured using a BR 102 Plus PWA device in perioperative time after kidney transplantation

Official Title
-----------------
Noninvasive Perioperative Monitoring of Arterial Stiffness, Volume and Nutritional Status in Stable Renal Transplant Recipients

Conditions
-----------------
Arterial Calcification, Aortic Stiffness, High Blood Pressure, Kidney Transplantation

Intervention / Treatment
-----------------
* Device: BR-102 plus PWA
* Device: Tanita MC780 MA S


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: give voluntary consent to participate in the study no clinical cardiovascular disease during the 6 months preceding entry Exclusion Criteria: not meet the above criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Patients before kidney transplantation<br>The study included who had been admitted to the TransplantClinic before kidney transplantation | Device: BR-102 plus PWA<br>* Monitoring of Arterial Stiffness and Central Aortic Pressure<br>Device: Tanita MC780 MA S<br>* The device measured the size of total body water (TBW), Extra Cellular Water (ECW), Intra Cellular Water (ICW), fat mass (FM%), visceral fat%, fat free mass (FFM) and basal metabolic rate, (BMR) (kcal).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in pulse wave velocity [m/s] in short postoperative period. | Assessment will be performed one day before kidney transplantation and two days after kidney transplantation | 3 days (one day before kidney transplantation and two days after kidney transplantation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in central aortic pressure [mmHg] in short postoperative period. | Assessment will be performed one day before kidney transplantation and two days after kidney transplantation | 3 days (one day before kidney transplantation and two days after kidney transplantation) |
Evaluation of the Prognostic Value of the Suppression Ratio Evaluated by BIS Among Patients Admitted to the ICU for Cardiac Arrest

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the prognostic value of the suppression ratio monitored by Bispectral Index for prediction of neurologic outcome after cardiac arrest. All patient admitted to our intensive care unit after a cardiac arrest are included. The results of the suppression ratio will be collected in the 6 first hours of admission. We will evaluate the link between suppression ratio and cerebral performance category score collected at three months.

Official Title
-----------------
Evaluation of the Prognostic Value of the Suppression Ratio Evaluated by BIS Among Patients Admitted to the ICU for Cardiac Arrest

Conditions
-----------------
Cardiac Arrest

Intervention / Treatment
-----------------
* Device: Aspect BIS XP (A-2000) Bispectral Index Patient Monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult Cardiac arrest admitted to the ICU Exclusion Criteria: - Pregnancy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm<br>arm wherein all patients Suppression Ratio evaluated by BIS will be collected | Device: Aspect BIS XP (A-2000) Bispectral Index Patient Monitor<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral Performance Category score |  | 3 months |
One-step Nucleic Acid Amplification for Detecting Lymph Node Metastasis of Head and Neck Squamous Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
The investigators main objective is to show that OSNA technique is as accurate as pathological analysis (frozen section / HE staining and immunochemistry) to detect occult lymph node metastasis (micro and macrometastasis).

Official Title
-----------------
Etude de Concordance Entre la Technique OSNA et Les Techniques Classiques Pour la Recherche de métastases Ganglionnaires Des Cancers Des VADS

Conditions
-----------------
cN0 Oral Squamous Cell Carcinomas

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient > 18 years old Head and neck squamous cell carcinoma diagnosed by biopsy N0 classification (N0: no lymph node invasion on clinical and radiological examination). Neck dissection or sentinel lymph node biopsy required to treat the patient ECOG 1,2 or 3 Patient's consent Exclusion Criteria: Patient previously treated by radiotherapy or surgery for head and neck neoplasm. Contraindication or patient unwillingness to undergo surgical treatment Incapacitated adults

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 |
| --- | --- | --- |
| number of CK19 mRNA copies/µL of diluted lymph node lysate |  | through study completion, an average of 1 year |
Comparisons of the Impact of Duloxetine Versus Imipramine on Therapeutic Efficacy, Psychological Distress, Sexual Function, Urethral and Bladder Wall Structure and Blood Flow in Women With Stress Urinary Incontinence: a Randomized Controlled Study

Study Overview
=================
Brief Summary
-----------------
To assess the impact of Duloxetine and Imipramine on therapeutic efficacy, psychological distress, sexual function, bladder wall structure and blood flow in women

Detailed Description
-----------------
To assess the impact of Duloxetine and Imipramine on therapeutic efficacy, psychological distress, sexual function, bladder wall structure and blood flow in women

Official Title
-----------------
Comparisons of the Impact of Duloxetine Versus Imipramine on Therapeutic Efficacy, Psychological Distress, Sexual Function, Urethral and Bladder Wall Structure and Blood Flow in Women With Stress Urinary Incontinence: a Randomized Controlled Study

Conditions
-----------------
Stress Urinary Incontinence

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Stress urinary incontinence Exclusion Criteria: Take monoamine oxidase Myocardial infarction critical,cardiovascular insufficiency (such as room blocking, arrhythmia, blood-soaked heart failure, myocardial infarction, stroke and excessive heartbeat). Allergy to duloxetine or imipramine Uncontrolled angular glaucoma patients Pregnant women

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Duloxetine<br>Receive Duloxetine 30 mg treatment per day | Drug: Duloxetine<br>* Duloxetine 30 mg qd<br>|
| Active Comparator: Imipramine<br>Receive Imipramine 25 mg treatment per day | Drug: Imipramine<br>* Imipramine 25mg qd<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the score of International Consultation on Incontinence Questionnaire-Urinary Incontinence | Between-group difference in the score of International Consultation on Incontinence Questionnaire-Urinary Incontinence | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the score of Urgency Severity Scale | Between-group difference in the score of Urgency Severity Scale | 8 weeks |
Adalimumab (Humira) in the Treatment of Refractory Non-infectious Uveitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and efficacy of Adalimumab in uveitis.

Official Title
-----------------
An Open-label, Multicenter, Phase II Trial of Adalimumab (Humira) in the Treatment of Refractory Non-infectious Uveitis

Conditions
-----------------
Uveitis

Intervention / Treatment
-----------------
* Drug: Adalimumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with vision-threatening autoimmune uveitis. Failure to respond to prednisone and at least one other systemic immunosuppressive (such as methotrexate, azathioprine, mycophenolate mofetil, cyclosporine, cyclophosphamide, or chlorambucil), or intolerance to such medications due to side effects. Exclusion Criteria: Serious concomitant illness that could interfere with the subject's participation in the trial. Previous or current use of cyclophosphamide. Unable or unwilling to undergo multiple injections.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adalimumab<br> | Drug: Adalimumab<br>* 40 mg delivered every 2 weeks by subcutaneous injection<br>* Other names: Humira;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Endpoint | Improvement in at least one of these criteria without significant worsening in any of them. 1) improvement by 2 or more lines of best-corrected Snellen visual acuity in at least one eye; (2) reduction in dose of systemic corticosteroid or other immunosuppressive therapy by at least 50%; (3) two-step improvement in control of ocular inflammation; and (4) reduction of cystoid macular edema and other inflammatory signs on angiography. | 10 weeks | 
| Cumulative Endpoint | Improvement in at least one of these criteria without significant worsening in any of them. 1) improvement by 2 or more lines of best-corrected Snellen visual acuity in at least one eye; (2) reduction in dose of systemic corticosteroid or other immunosuppressive therapy by at least 50%; (3) two-step improvement in control of ocular inflammation; and (4) reduction of cystoid macular edema and other inflammatory signs on angiography. | 50 Weeks |
Best Therapy for Patients With Neuroendocrine Tumors

Study Overview
=================
Brief Summary
-----------------
A prospective observational study containing three arms comprising different therapeutic measures to treat patients with neuroendocrine tumors in advanced stages. The therapy arms include local ablative therapy such as TACE or SIRT, surgery and RFA with peptide receptor radiotherapy.

Detailed Description
-----------------
Study design: Prospective observational study comparing ablative measures as TACE or SIRT with surgery/RFA and with peptide receptor radio-therapy in patients with advanced well-differentiated neuroendocrine tumors with lymph node or distant metastases (N1, M1) Prospective evaluation Primary end points: time to progression Secondary end points: survival, quality of life (EORTC-QLQ30), weight, time of hospitalization, Karnofsky index) Non-randomized cohort study Number of patients needed in all groups: 70 per group, 210 overall Evaluation of response to therapy every 3-6 months by imaging, clinical status, weight, quality of life, Karnofsky-index Cross-over allowed if therapy changes

Official Title
-----------------
Best Therapy for Patients With Neuroendocrine Tumors

Conditions
-----------------
Neuroendocrine Tumors

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Biopsy-proven neuroendocrine tumor (WHO class I-II, TNM grading 1-2) Advanced disease with lymph node or distant metastases (N1, M1) undergoing cytoreduction by surgery/local ablative therapy or peptide receptor radiotherapy curative intent of all therapies possible Exclusion Criteria: Undifferentiated neuroendocrine carcinoma (WHO class III, TNM grading 3) secondary tumor advanced carcinoid heart disease requiring surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 local ablative therapy such as transcatheter-arterial chemoembolization or selective interal radiotherapy | |
| 2<br>patients undergoing surgery or radiofrequency ablation | |
| 3<br>patients undergoing peptide receptor radiotherapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival, quality of life (EORTC-QLQ30), weight, time of hospitalization, Karnofsky index |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neuroendocrine tumors, transcatheter arterial chemoembolization, selective internal radiotherapy, surgery, radio-frequency ablation, peptide-receptor radiotherapy, progression-free survival, quality of life, overall survival, weight, time of hospitalization