linjc16/ctgov huggingface dataset:
Evaluation of the Physiodoloris Pain Monitor in Patients With Complex Regional Pain Syndrome

Study Overview
=================
Brief Summary
-----------------
A French University team (M. Jeanne, MD, and M. LOGIER, Ph D) have developed a pain assessment tool based on the analysis of the variability heart rate which evaluates the Analgesia Nociception Index (ANI). This index is intended to give a quantification of pain. The aim of the present study is to assess the validity of the ANI parameter in patients with Complex Regional Pain Syndrome treated with a nerve block (reversible pain).

Official Title
-----------------
Evaluation of Non-invasive Monitor of Physiodoloris Pain in Patients With Complex Regional Pain Syndrome Treated by Nerve Block (Prospective Monocenter Study)

Conditions
-----------------
Complex Regional Pain Syndrome

Intervention / Treatment
-----------------
* Drug: Ropivacaine 0.5%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients suffering from a Complex Regional Pain Syndrome of the upper or lower limb Exclusion Criteria: contra-indication of a nerve block, contra-indication of the use of the pain monitor

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: Perineural block<br>Perineural block with Ropivacaine 0.5% | Drug: Ropivacaine 0.5%<br>* Ropivacaine is used to performed the perineural block<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of ANI before the peri-neural block | ANI is recorded before each nerve block | 5 minutes | 
| Evaluation of pain before the peri-neural block | Pain score is recorded before each nerve block | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of ANI after the peri-neural block | ANI is recorded after each nerve block | 10 minutes | 
| Evaluation of pain after the peri-neural block | Pain score is recorded after each nerve block | 10 minutes |
Registry of Food Allergy Oral Immunotherapy Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this patient registry is to demonstrate safety and efficacy of food oral immunotherapy in food allergic patients. Factors that lead to adverse reactions will be identified. The frequency of rescue epinephrine use will be recorded.

Detailed Description
-----------------
Each participating US clinic is assigned a site number and patients starting food oral immunotherapy will be given a four digit number starting at 0001 within each site. All data will be collected and reported electronically at each clinical site.

Official Title
-----------------
National Registry of Food Allergy Treatment

Conditions
-----------------
Food Allergy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a history of an allergic reaction following exposure to the food and positive in-vivo or in-vitro sensitivity testing to the food, no prior exposure to the food, but markedly high in-vitro specific immunoglobulin E (IgE) to the food Exclusion Criteria: pregnancy severe asthma poorly controlled atopic dermatitis eosinophilic esophagitis
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 |
| --- | --- | --- |
| efficacy of food allergy treatment | the percentage of patients who successfully reach the maintenance dose of food | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| epinephrine use | The frequency of epinephrine use during the course of oral immunotherapy as reported in the prospective database. Also, identify factors that are associated with the need for epinephrine. | 3 years | 
| factors associated with the failure to reach the target dose of food ingestion | Identify factors that are associated with treatment failures through analysis of patient demographics, baseline laboratory test results, and concomitant atopic conditions. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
food anaphylaxis, peanut anaphylaxis, food oral immunotherapy, food allergy, food allergy treatment
ALK21-021: A Safety Study of Medisorb® Naltrexone (VIVITROL®) Administered to Health Care Professionals

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and tolerability of Medisorb® naltrexone (VIVITROL®) when administered over a period of 24 months to health care professionals who have a history of opioid dependence.

Official Title
-----------------
Open-Label Study of the Safety and Tolerability of VIVITROL Administered to Health Care Professionals Participating in an Extended Outpatient Treatment Program for Opioid Dependence

Conditions
-----------------
Opiate Dependence

Intervention / Treatment
-----------------
* Drug: Medisorb naltrexone 380 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Primary Inclusion Criteria: Health care professional (eg, physician, osteopath, nurse, pharmacist) 18 years of age or older Enrolled or enrolling in an extended outpatient treatment program for opioid dependence Women of childbearing potential must agree to use an approved method of contraception for the duration of the study Primary Exclusion Criteria: Pregnancy and/or lactation Evidence of hepatic failure Active hepatitis Any psychiatric disorder that would compromise ability to complete study requirements Recent history of suicidal ideation or attempt Current dependence to any drugs other than prescription opioids or heroin, benzodiazepines, caffeine, marijuana, alcohol, or nicotine Positive urine drug test or self-reported use of opioids, cocaine, or amphetamines at screening

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: Medisorb naltrexone 380 mg (VIVITROL)<br> | Drug: Medisorb naltrexone 380 mg<br>* Intramuscular (IM) injection administered once every 4 weeks for up to 2 years<br>* Other names: Naltrexone for extended-release injectable suspension;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study. | A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period). | 2 years (Baseline to end of study) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
opioid dependence, VIVITROL, opioid-related disorders
Effectiveness of a Educational Intervention to Improve the Resolution Capacity of Primary Health Care Teams.

Study Overview
=================
Brief Summary
-----------------
There is a great variability in the different primary care teams referral rate. And variability means inappropriateness somewhere in the process of care. The most important determinants of the variability are the attitude and knowledge of the professional, the existence and availability of evidence, the resources available and the professionals practice style. To improve the knowledge of the professionals could be a way to decrease the variability. Because of this, we have the aim to determinate the effectiveness of an educational intervention to improve the primary care teams from the city of Barcelona referral rate.

Detailed Description
-----------------
The aim of our study is to determinate if an active educational intervention (interactive sessions discussing clinical cases plus the minimal intervention) reduces the professionals referral rate compared with the minimal intervention group (written adapted clinical practice guidelines and feedback about their referral rate compared with other primary care teams). It is a cluster-randomized controlled trial stratified by the percentage of reform and the referral rate. The subjects were primary care physicians of the 51 teams of Barcelona city attending 1.160.748 inhabitants.

Official Title
-----------------
Phase IV Cluster Randomised Controlled Trial With 2 Parallel Groups, to Evaluate the Effectiveness of a Educational Intervention to Improve the Resolution Capacity.

Conditions
-----------------
Referral and Consultation

Intervention / Treatment
-----------------
* Procedure: Educational interactive intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary care teams who agree to participate. Primary care teams attending adult population (older than 14). Exclusion Criteria: Primary care teams where the intervention would be difficult to take place. Primary care teams where the referral rate is not available. Primary care teams with a percentage of reform lower than 40%.
Sexes Eligible for Study
-----------------
All

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

Design Details

Primary Purpose: Educational/Counseling/Training
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Educational interactive intervention|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of referrals of the selected condition done by the primary care professionals to specialized consultants by 100 patients attended in 1 year. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Effectiveness, Educational intervention, Primary health care
Epidemiologic Study Of The Distribution Of Vaccine-Type Streptococcus Pneumoniae Serotypes In Adults In The US With Community-Acquired Pneumonia

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to use an investigational urine assay to estimate the proportion of pneumonia in adults 50 years or older in different areas throughout the US that is caused by certain types of the bacteria Streptococcus pneumoniae (also called pneumococcus).

Official Title
-----------------
Distribution Of PCV13 Serotype Streptococcus Pneumoniae In Adults 50 Years And Older Presenting To Select US Hospitals With Radiographically-Confirmed Community-Acquired Pneumonia (CAP)

Conditions
-----------------
Pneumonia, Pneumococcal, Vaccines, Pneumococcal

Intervention / Treatment
-----------------
* Procedure: Urine sample collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 50 years and older. Presents to a study site with clinically suspected pneumonia. Has a radiographic finding that is consistent with pneumonia. Able and willing to provide urine. Exclusion Criteria: Transfer to a study hospital after already being hospitalized for 48 hours or more at any other inpatient facility (such as community hospital). Hospital-acquired pneumonia (ie, pneumonia developing 48 hours after hospital admission). Previous enrollment in this study within the past 30 days.

Ages Eligible for Study
-----------------
Minimum Age: 50 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> | Procedure: Urine sample collection<br>* All subjects have non-invasive urine sample collection performed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects who have vaccine-type (VT), ie, PCV13, S. pneumoniae. |  | 6-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with VT-type pneumonia by previous healthcare facility exposure status will be described by site. |  | 6-12 months | 
| Proportion of subjects with detection of S. pneumoniae by culture, BinaxNOW, and UAD assay will be summarized by method. |  | 6-12 months | 
| Serotype distribution of S. pneumoniae cases by site and across all sites. |  | 6-12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pneumococcal pneumonia, community-acquired pneumonia
Safety and Effectiveness of Adding Saquinavir (FORTOVASE) in Soft Gel Capsule Form to an Anti-HIV Drug Combination in HIV-Infected Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if it is safe and effective to give saquinavir (as a soft gel capsule taken by mouth) along with 2 other anti-HIV drugs to HIV-infected patients.

Detailed Description
-----------------
Prior to initiation of study treatment all patients are screened and baseline lab values are taken. Patients then receive the study treatment, FORTOVASE, two times a day plus 2 new NRTI's. Assessments will be performed at specified intervals throughout the duration of treatment.

Official Title
-----------------
A Phase IV, Non-Comparative Study to Evaluate FORTOVASE (Saquinavir) Soft Gel Capsule (SGC) TID Regimen in Combination With Two NRTI's in HIV-1 Infected Women and Men

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Saquinavir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria You may be eligible for this study if you: Are HIV-positive. Have an HIV count of 5,000 copies/ml or more. Have a CD4 count of 100 cells/mm3 or more. Meet specific requirements if you have ever taken NRTIs. Are 16 - 64 years old (need consent if under 18). Agree to use effective methods of birth control during the study. Exclusion Criteria You will not be eligible for this study if you: Have taken non-nucleoside reverse transcriptase inhibitors (NNRTIs) or protease inhibitors (PIs) for more than 2 weeks. Have taken all the available NRTIs. Have certain serious medical conditions, including severe liver disease or active opportunistic (AIDS-related) infection. Have a history of weight loss, muscle pain, and loss of appetite. Have taken certain medications, including anti-HIV drugs other than those required by this study. Are pregnant or breast-feeding. Abuse alcohol or drugs. Are unable to complete the study for any reason.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 64 Years

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

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

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

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Saquinavir|nan|

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
-----------------
Drug Therapy, Combination, HIV Protease Inhibitors, Dosage Forms, Saquinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents
Study Comparing Pulmonary Vein Isolation With the Cryoballoon and Radiofrequency Energy(Contact Force) in the Treatment of Persistent Atrial Fibrillation (AF) (Cryo Vs CF in PerAF)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to perform a prospective, randomised study investigating the safety and efficacy of cryoballoon catheter ablation compared with radiofrequency ablation(contact force), in the treatment of persistent AF.

Detailed Description
-----------------
The hypotheses for this study is that cryothermal energy is as effective and safe as using radiofrequency energy in the treatment of persistent AF and is associated with a better long term outcome.

Official Title
-----------------
Study Comparing Pulmonary Vein Isolation With the Cryoballoon and Radiofrequency Energy(Contact Force) in the Treatment of Persistent Atrial Fibrillation (PerAF)

Conditions
-----------------
Persistent Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: Cryoballoon
* Device: Radiofrequency Energy(Contact Force)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: persistent Atrial Fibrillation; Intolerant to antiarrhythmic medication; Both male or female; Age from 18 to 75 years old. Exclusion Criteria: Acute myocardial infarction; Coronary artery stent history; Acute severe stroke; Abnormal liver and renal function.

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cryoballoon<br> | Device: Cryoballoon<br>* use Cryoballoon to isolation the Pulmonary Vein<br>Device: Radiofrequency Energy(Contact Force)<br>* use Radiofrequency Energy(Contact Force) to isolation the Pulmonary Vein<br>|
| Experimental: Radiofrequency Energy(Contact Force)<br> | Device: Cryoballoon<br>* use Cryoballoon to isolation the Pulmonary Vein<br>Device: Radiofrequency Energy(Contact Force)<br>* use Radiofrequency Energy(Contact Force) to isolation the Pulmonary Vein<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with successful Pulmonary Vein Isolation |  | in one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cryoballoon, Contact Force, Persistent Atrial Fibrillation
Non-grafted Maxillary Sinus Floor Elevation With Simultaneous Implant Placement Using Different Implant Lengths

Study Overview
=================
Brief Summary
-----------------
twenty recruited patients indicated for sinus augmentation and simultaneous implant placement will be divided into two groups (10 in each of the groups).to evaluate & compare bone formation & implant stability after shneiderian membrane elevation and augmentation with graft less tenting technique with different implant lengths. group one will receive 8mm implant lenght while group two will receive 10mm implants.

Official Title
-----------------
Non-grafted Maxillary Sinus Floor Elevation With Simultaneous Implant Placement Using Different Implant Lengths

Conditions
-----------------
Maxillary Sinus Lift

Intervention / Treatment
-----------------
* Procedure: maxillary sinus lift


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with atrophic maxilla & pneumatized maxillary sinus with residual bone height at least 4mm of residual ridge both sexes Exclusion Criteria: patients with systematic diseases that may affect normal healing sinus pathology heavy smokers more than 20 cigarettes per day

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: active comparator<br> | Procedure: maxillary sinus lift<br>* non grafted maxillary sinus floor augmentation with simultaneous implant placement<br>|
| Experimental: placebo<br> | Procedure: maxillary sinus lift<br>* non grafted maxillary sinus floor augmentation with simultaneous implant placement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| height of gained bone | two cone beam CT will be done for the patients, one immediate post operative & the other 6 months post operative then the amount of gained bone will be assessed by superimposing the same section in the two cone beam CT. | 6 months post operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implant stability | measurement of the implant stability using OSSTELL device. | will be measured intra operative after implant insertion and will be measured once more 6 months post operative after the first operation at the time of implant exposure |