linjc16/ctgov huggingface dataset:
Effects of Benzocaine 20% Topical Anesthetic and no Topical Agent on Pain Perception During Intra-oral Injections

Study Overview
=================
Brief Summary
-----------------
The aim of this randomized controlled trial. is to test the efficacy of topical anesthesia against the use of no topical agent during buccal infiltration in maxillary anterior teeth. The rationale behind this comparison is to evaluate the practical, clinical outcome of not using any topical agent if in fact topical anesthesia does not reduce pain as reported by various studies and if consequently its usage was to be discontinued.

Detailed Description
-----------------
The clinical implication of topical anesthesia and placebo being the same is to not use either of them prior to LA administration in dentistry. This clinical approach has rarely been studied and this study aims to compare the effects of the use of topical anesthesia against the use of no topical agent prior to buccal infiltration in maxillary anterior teeth.

Official Title
-----------------
Efficacy of Topical Benzocaine in Anterior Maxilla: A Randomised Controlled Trial

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Procedure: No topical anesthesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Above the age of 18 Males and females both Participants requiring extraction of maxillary anterior teeth Intact or minimally restored anterior teeth Patients with American Society of Anesthesiologists physical status of 1 or 2 Exclusion Criteria: Participants with physical American Society of Anesthesiologists physical status of 3 or 4 Showing signs of inflammation in the area to be injected Having known allergy to any of the agents used in the study Used anti- anxiety drugs or sedatives in the past two weeks Have taken analgesics on the day of data collection

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Topical Anesthesia | |
| Experimental: Study group<br>No topical anesthesia | Procedure: No topical anesthesia<br>* Lack of use of topical anesthesia application prior to infiltration injection intra-orally<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score on needle penetration | Pain score measured by numeric pain rating scale | Immediately | 
| Pain score on local anesthesia deposition | Pain score measured by numeric pain rating scale | Immediately | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain, Benzocaine, Clinical trial
Resolution of Allergic Inflammation

Study Overview
=================
Brief Summary
-----------------
After an allergen challenge, the allergic inflammatory response disappears spontaneously. The initiation of the resolution of the inflammatory response is now recognized as a dynamic process, involving active biochemical programs that enable inflamed tissues to return to homeostasis. Recent data established key roles of different specific lipid mediators in the endogenous counter-regulation of inflammation and activation of resolution. Only little is known about kinetics of these specialized pro-resolving lipid mediators during acute allergic inflammation. Therefore, the primary propose of our study is to characterize the temporal evolution of cellular inflammation and specific lipid mediators after allergen challenge.

Official Title
-----------------
Resolution of Allergic Inflammation: Identification and Kinetics of Specific Lipid Mediators During Nasal Allergen Challenge

Conditions
-----------------
Grass Pollen Allergic Rhinitis

Intervention / Treatment
-----------------
* Other: Grass pollen allergen extract
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Eligibility criteria: Inclusion Criteria Allergic rhinitis during the grass pollen season with or without asthma, with at least one of the following symptoms: nasal congestion, itching, rhinorrhea, sneezing Grass pollen sensitization determined by a positive skin prick test and / or presence of specific IgEs to a grass pollen allergen extract Exclusion Criteria: Smoker Specific immunotherapy with grass allergens or other respiratory allergen for inclusion. Current exhibition to another clinically relevant respiratory allergen

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: measurement of mediators in biological fluids<br> | Other: placebo<br> <br> |
| Experimental: Grass pollen allergen extract<br> | Other: Grass pollen allergen extract<br>* Each subject will be challenged with a grass pollen allergen extract and with placebo.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical nasal score and measurement of mediators in biological fluids |  | Measurement of mediators in biological fluids during 72 h after nasal allergen challenge | 
| Clinical nasal score and measurement of mediators in biological fluids. |  | Measurement and indentification of specific lipid mediators during nasal allergen challenge |
Pancreatic Cancer and Carbon Ion Radiotherapy

Study Overview
=================
Brief Summary
-----------------
Irradiation of non-operable pancreatic cancer with carbon ions (C12). This therapy is expected to be more effective than the current Gold Standard of photon irradiation applied in the case of non-operable pancreatic cancer.

Official Title
-----------------
Pancreatic Cancer and Carbon Ion Radiotherapy

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Radiation: Carbon Ion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed, inoperable primary or local recurrent pancreatic cancer Written informed consent (must be available before enrollment in the trial) Karnofsky performance score > 60 or ECOG-status 0/1 (at least: patient should be able to take care of himself, although daily-life activity or work is not possible) Age ≥ 18 years Exclusion Criteria: No clear difference between tumor edge and upper gastrointestinal tract in baseline imaging Extensive lymphatic metastases Disability of subject to understand character and individual consequences of the clinical trial Distant metastases Previous radiotherapy of the upper abdomen Active medical implants (e.g. pacemaker, defibrillator), contradicting radiotherapy at HIT Participation in another clinical study or observation period of competing trials, respectively

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: Interventional arm<br>Carbon Ion Radiation 12 x 4 Gy (RBE) within 2 weeks | Radiation: Carbon Ion<br>* 12 x 4 Gy (RBE)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival | overall survival | 12 month after radiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| toxicity outcomes | Incidence of grade 3/4 NCI-CTC-AE toxicity | 48 Month after radiatoin | 
| survival | Progression free survival | 12 month after radiation | 
| Blood Parameters Ca 19-9 | Change in Ca 19-9 | 48 Month after radiation | 
| Blood Parameters CEA | Change in CEA levels | 48 Month after radiation | 
| Quality of life (QLQ) EORTC QLQ C30 | Change on scoring on EORTC QLQ C30 | 48 Month after radiation | 
| Quality of life EORTC QLQ Pan26 | Change on scoring EORTC QLQ Pan26 | 48 Month after radiation |
Evaluation of Percutaneous Treatment by Cryoablation of Unifocal Invasive Breast Carcinoma in Menopausal Women With Indication of Lumpectomy

Study Overview
=================
Brief Summary
-----------------
The primary objective of this monocentric and feasibility study is to review the efficacy of cryotherapy in the treatment of unifocal mammary carcinomas in post-menopausal patients, with lumpectomy indication. The efficacy is defined by the rate of success of cryotherapy procedures. For each one of those evaluated process, an success will be defined on the tumor sample of lumpectomy by the absence of viable tumour cells. On the basis of our expertise, it seems interesting to propose this experimental procedure to patients as described above.

Official Title
-----------------
Evaluation of Percutaneous Treatment by Cryoablation of Unifocal Invasive Breast Carcinoma in Menopausal Women With Indication of Lumpectomy

Conditions
-----------------
Carcinoma, Ductal, Breast, Menopausal

Intervention / Treatment
-----------------
* Device: Cryoablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non inflammatory unilateral and unifocal breast cancer with indication of lumpectomy Menopausal women with age > 55 years Tumor size <= 15 mm by ultrasonography Histological confirmation (by biopsy) of invasive ductal carcinoma with SBR (Scarff-Bloom-Richardson) grade (modified by Ellis & Elston) 1 or 2; hormone receptors positive (Estrogen Receptor and/or Progesterone Receptor) and negative Human epidermal growth factor receptor (HER2) Good lesion boundary with ultrasonography and MRI Minimal distance of 5 mm between the skin and the tumor Performance Status 0-1 Ability to understand and willingness to sign a written informed consent document Covered by a medical insurance Signed informed consent Exclusion Criteria: Invasive lobular carcinoma Tumor with retro-nipple location Extended microcalcifications (> 15 mm) with mammography Xylocaine allergy Patient deprived of freedom

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

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

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: Cryoablation<br>Cryoablation of the tumor followed by a lumpectomy as practiced in standard care | Device: Cryoablation<br> <br> * Other names: Cryotherapy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of success of cryoablation procedure | percentage of viable cells in the piece of lumpectomy | 45 days after cryoablation |
Clinical Use of Prilocaine Chlorhydrate Among a General Surgical Population

Study Overview
=================
Brief Summary
-----------------
Observation of the effects of an administration of prilocaine chlorhydrate hyperbare in rachianesthesia among a general surgical population.

Official Title
-----------------
Clinical Use of Prilocaine Chlorhydrate Among a General Surgical Population

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Drug: Prilocaine Chlorhydrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 500 consecutive patients with a spinal anesthesia Exclusion Criteria: Patient's refusal Age < 18 years

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 |
| --- | --- |
| Study Group<br>All patients included in the study | Drug: Prilocaine Chlorhydrate<br>* Use of prilocaine in spinal anesthesia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of action |  | Baseline |
Seniors'Health Paths  PAERPA ,

Study Overview
=================
Brief Summary
-----------------
•Background: PAERPA experimentation implemented in the East-Herault region since September 2017 aims to identify fragility and prevent the risk of loss of autonomy in elderly persons older than 60 years by facilitating coordination between Professionals taking care of the patient with the personalized health plan  PPS. The main objective of this study was to evaluate the implementation of this device through the achievement or not of the objectives set by the PPS. •Methods: Descriptive cohort study with retrospective inclusion and prospective follow-up from the East Herault CTA database. All patients over 60 years old living at home and having a PPS written between September 2017 and April 2018 were included. PPS monitoring for 1 year. Description of this population then analysis of PPS. •Discussion: Our study aims to evaluate the implementation of the device to identify ways to improve the device for the management of subjects at risk of loss of autonomy.

Official Title
-----------------
Seniors'Health Paths  PAERPA , a Support Being Made Available to General Practionners for Assistance in the Management of Elderly Persons at Risk of Losing Their Independence. Review of the Implementation of the Arrangement on the Est-héraultais Territory.

Conditions
-----------------
Loss of Autonomy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: An individual must fulfill all of the following criteria in order to be eligible for study enrollment: Aged of 60 years and more individual health care plan was prepared living in the Est-Héraultais territory Exclusion Criteria: Hospitalized patients Patients who declined to have an individual heath care planPsychosis

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- | --- |
| Estimating goals set by the PPS (personalized health plan) | achievement of objectives established in the individual health care plan after 6 and 12 month follow-up | 6 and 12 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between unwillingness and cognitive disorder | correlation between unwillingness and cognitive disorder | 1 day | 
| Correlation between unwillingness and numbers of established goals | Correlation between unwillingness and numbers of established goals | 1 day | 
| Correlation between unwillingness and locomotors goals | Correlation between unwillingness and locomotors goals | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aged of 60 years and more, living in the Est-Héraultais territory, seniors'health paths, PAERPA
Microwave Ablation of Resectable Liver Tumors

Study Overview
=================
Brief Summary
-----------------
The purpose of this protocol is to pathologically evaluate the destruction by microwave ablation of primary and metastatic liver tumors. The primary aim is to measure tissue destruction with the MedWaves Microwave Ablation/ Coagulation Ablation System.

Detailed Description
-----------------
Minimally invasive surgical alternatives are becoming more attractive for the treatment of malignancy.The goal is to reduce morbidity and mortality and increase the ability to treat patients in the outpatient setting. Image-guided ablation is becoming an attractive alternative because of its relative low cost, its ability to provide large regions of coagulative necrosis in a controlled fashion, and its relatively low toxicity. Although image-guided ablative techniques have been extensively investigated for the treatment of liver tumors, there has been limited experience with microwave ablation (MWA) in the liver. This study will evaluate the treatment effect of MWA in liver tumors. Patients undergoing planned surgical removal of liver tumors will have the tumors intra-operatively treated with MWA. The histological changes will be evaluated upon removal of the specimen.

Official Title
-----------------
Microwave Ablation of Resectable Liver Tumors

Conditions
-----------------
Hepatocellular Carcinoma, Liver Cancer

Intervention / Treatment
-----------------
* Device: Microwave Ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of primary or metastatic liver cancer for which surgery is planned All participants need to be fully able to give informed consent Exclusion Criteria: Mental or legal incompetence Impaired decision-making capacity Pregnant women may not participate

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

| Intervention/Treatment |
| --- |
|Device: Microwave Ablation|Tumor tissue from the liver is inter-operatively treated with the microwave ablation device to measure the destruction of tissue.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of the tissue destruction with the MedWaves Microwave Ablation/ Coagulation Ablation System | Measure of the tissue destruction with the MedWaves Microwave Ablation/ Coagulation | 30 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liver cancer, Tumors
Ambulatory Versus Home Blood Pressure Monitoring in Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
Subjects referred to a sleep clinic had polysomnography (PSG), clinic BP measurements, 24-hour ABP monitoring and HBP monitoring using a device (Microlife WatchBP HomeN) that allows daytime (3 days, 2 duplicate readings/day) and automated nighttime BP measurement (3 nights, 3 readings/night).

Official Title
-----------------
Ambulatory Versus Home Blood Pressure Monitoring in Obstructive Sleep Apnea

Conditions
-----------------
Obstructive Sleep Apnoea, Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≤ 65 years Suspected OSA Treated or untreated for hypertension Exclusion Criteria: History of cardiovascular disease (heart failure, coronary heart disease, arrhythmia or stroke) History of asthma or chronic obstructive pulmonary disease (FEV1/FVC <70%) History of diabetes mellitus, collagen diseases and sarcoidosis Serum creatinine >1.6 mg/dl, proteinuria Previous treatment with CPAP Pregnancy or menstruation during the study Treatment with steroids, lithium or any other drugs affecting BP Change in antihypertensive treatment(if any) in the last 8 weeks before study entry

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 Study Comparing Continuous Subcutaneous Insulin Infusion With Multiple Daily Injections With Insulin Lispro and Glargine

Study Overview
=================
Brief Summary
-----------------
This trial will compare the metabolic control in type 1 diabetes obtained by continuous infusion of insulin lispro with that obtained by multiple daily injections of insulin lispro and glargine, a long-acting insulin analogue. Patients will be switched to the alternative treatment after 4 months. Glucose variability in the last month of each treatment will be analyzed.

Official Title
-----------------
A Study Comparing Continuous Subcutaneous Insulin Infusion With Multiple Daily Injections With Insulin Lispro and Glargine

Conditions
-----------------
Diabetes Mellitus Type 1

Intervention / Treatment
-----------------
* Device: Insulin pumps


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetic patients, 18-60 years of age Diabetic for >2 years Treated with CSII for >=6 months HbA1c <8.5% Exclusion Criteria: Treatment with daily insulin injections Inability to handle pump therapy Untreated retinopathy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Device: Insulin pumps<br> <br> |
| Experimental: B<br> | Device: Insulin pumps<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variability of blood glucose characterised by the standard deviation of the mean blood glucose |  | Length of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | Length of study | 
| Mean BG during the last month of the respective treatment period |  | Length of study | 
| Frequency of severe hypoglycemia |  | Length of study | 
| Daily insulin requirement |  | Length of study |