linjc16/ctgov huggingface dataset:
Retrospective Study of Bone Infection Due to Campylobacter Spp

Study Overview
=================
Brief Summary
-----------------
Only 24 cases of Campylobacter bone and joint infection (BJI) have been reported worldwide between 1955 and 2008. Between 2010 and 2012, 7 cases were observed in two University hospitals in France. This increasing number of cases raises several issues. Are they the consequences of better detections and reporting, or are they reflecting any epidemiologic changes? For answering these questions, we performed a 10 year (2002-2012) retrospective multicenter (6 centers) study on BJI (native and implanted joints) due to Campylobacter species.

Detailed Description
-----------------
Methods: By browsing the microbiological database of 6 BJI French reference centers, we collected all cases due to Campylobacter species between 2002 and 2012, including first and relapse cases. Clinical, microbiological and treatment features were analyzed using descriptive statistics. Results: 14 episodes of BJI due to Campylobacter spp were identified in 10 patients. Mean age was 76.8 y.o. (63-96). Sex ratio M/F was 1.5. Nine patient had hip (n=6), knee (n=2), and shoulder (n=2) implants. Immunosuppression was observed in 6 patients (3 cancers, 1 cirrhosis, 1 rheumatoid arthritis, 1 corticosteroid treatment). During the 10 primary cases: all patients had fever and 2 presented digestive symptoms. Campylobacter spp were isolated on per operative samples in 5 patients. One of them presented positive blood culture. 5 patients had joint punctures: all of them were positives. Campylobacter species were C. fetus (n=7), C. coli (n=2) and C. spp (1). Strains were resistant to nalidixic acid (=10), ciprofloxacin (n=4), erythromycin (n=3) or cefotaxime (n=2). Only one C. fetus was susceptible to all antibiotics tested. Surgical treatment was performed in 8 patients (2 two-stage procedure, 6 irrigation). The mean duration of adapted antibiotherapy was 77 days (26-237). 3 out of 4 relapse cases were due to C. fetus. All were resistant to more than one antibiotic classes.

Official Title
-----------------
Retrospective Study of Bone Infection Due to Campylobacter Spp

Conditions
-----------------
Campylobacter Infections, Bone Diseases, Infectious

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with peroperative bone samples positive to Campylobacter spp. between Jan 2002 and Dec. 2012 Adults over 18 yo No opposition to the study expressed by the patient Exclusion Criteria: Adults below 18 yo Spine infection to Campylobacter spp. Outside of the timeframe of the study No microbiologic data available Opposition to the study expressed by the patient
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 |
| --- | --- | --- |
| Incidence rate of reported prosthetic joint Campylobacter spp. Infections |  | 1986 to 2013 |
An Educational HIV Pre-Test Counseling Video Program for Off Hours Testing in the ED: A Randomized Control Trial

Study Overview
=================
Brief Summary
-----------------
This study compared the educational effectiveness of a ten-minute pre-test counseling video with the usual practice of a session with an HIV counselor.

Detailed Description
-----------------
HIV is increasingly affecting urban populations, making the inner city ED a prime venue for C&T because of their unique opportunity to identify HIV positive patients. These underserved communities often use the ED for their regular health care specifically because it provides services outside of the usual weekday working hours. However, there are significant barriers to HIV C&T in the ED, such as the lack of resources to provide prevention oriented messages, cost issues, and the feasibility of providing the required manpower for testing. The objective of this study is to determine whether an educational video, with the required pre-test counseling elements, conveys the necessary information for inner city ED patients to consent to a standard Elisa HIV test. In order to address the HIV testing needs of the patient population presenting to the ED, innovative methods must be developed to provide HIV C&T, while simultaneously removing the barriers to testing. Video technology may provide an opportunity to make HIV counseling feasible when counselors are not available.

Official Title
-----------------
An Educational HIV Pre-Test Counseling Video Program for Off Hours Testing in the ED: A Randomized Control Trial

Conditions
-----------------
HIV Counseling and Testing, HIV Infections

Intervention / Treatment
-----------------
* Procedure: Educational video


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients awaiting UC treatment were approached for the study. Patients 18 years of age and older were included Patients who spoke English and Spanish were included. Exclusion Criteria: Clinically unstable, Diagnosed with HIV Unable to understand the consent process because such patients require unique arrangements for consenting processes.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Educational video|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of mean knowledge score in both groups. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV prevention, HIV counseling, HIV testing, Emergency Medicine, HIV Seronegativity
Intra-stent Tissue Evaluation Within BMS and DES > 3 Years Since Implantation

Study Overview
=================
Brief Summary
-----------------
This study aims to test the hypothesis that plaque composition differs within a stent between bare metal stents and drug eluting stents (DES). It is possible that a difference in plaque composition seen within a stent may be contributory to the late thrombotic events seen more frequently with DES.

Official Title
-----------------
Intra-stent Tissue Evaluation Within BMS and DES > 3 Years Since Implantation

Conditions
-----------------
In-stent Coronary Artery Restenosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject > 18 years of age; Subject, male or female, who underwent DES or BMS implantation in a native coronary vessel more than 3 year ago; Subject is scheduled for a diagnostic coronary or interventional procedure; Subject is willing to sign the informed consent. Exclusion Criteria: Subject requires emergency catheterization; Subject has an acute myocardial infarction defined as anginal symptoms with ST-elevation on the EKG or creatine kinase-MB elevation >3times the upper limit of normal; Angiographic evidence of ≥ 70% stenosis within the target stent (visual estimate); Subject presented with cardiogenic shock; Subject has angiographically confirmed thrombus in the target coronary artery; Subject has a complex lesion not amenable to the IVUS/VH catheters and/or OCT catheters passing the stented segment; Subject has a contraindication to angiography/IVUS/OCT; Female subject is pregnant or lactating; Subject has life threatening comorbid conditions for which the investigator feels the subject should not be enrolled

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 |
| --- | --- |
| DES<br>Patients who received a DES stent > 3 years ago. | |
| BMS<br>Patients who received BMS stents > 3 years ago. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque composition | This study aims to test the hypothesis that plaque composition differs within the stent between BMS and DES. It is possible that a difference in plaque composition seen within the stent may be contributory to the late thrombotic events seen more frequently with DES. | During hospital stay, about 2 days. |
Evaluation of Oxygen Delivery Through Nasal Cannula in Volunteers

Study Overview
=================
Brief Summary
-----------------
This study will evaluate patient comfort and oxygen delivery efficiency when providing supplemental oxygen through a nasal cannula to volunteers using an instrumented oxygen delivery system. The goals of the study are to evaluate different oxygen flow rates and oxygen delivery modes. In addition, the investigators will investigate if the system can detect apnea (cessation of breathing) and removal of the nasal cannula. The investigators will also investigate how well high flow oxygen delivered only during inspiration is tolerated and how much the end-tidal oxygen increases after two minutes of high oxygen flow delivered only during the inhalation phase of the breath.

Conditions
-----------------
Oxygen Delivery, Patient Monitoring, Patient Comfort

Intervention / Treatment
-----------------
* Device: Supplemental Oxygen Delivery System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers drawn from the general public and students, staff, and faculty of the University of Utah. Exclusion Criteria: Volunteers who self report respiratory diseases such as acute respiratory distress syndrome, pneumonia and lung cancer will be excluded. In addition, volunteers who self report respiratory conditions such as nasal or bronchial congestion due to a cold or allergies will be excluded.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Supplemental Oxygen Delivery System|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End-tidal Oxygen | Did the novel system increase end-tidal oxygen? | Continuously throughout 30 minute volunteer study | 
| Patient Comfort | Did the patients feel it was more comfortable for a given end-tidal oxygen level? | Every 2 minutes up to 30 minutes | 
| End-tidal Carbon Dioxide | Was end-tidal carbon dioxide measured more accurately using the novel system? | Continuously throughout 30 minute volunteer study | 
| Respiratory Rate | Compared respiratory rate against capnometry. | Continuously throughout 30 minute volunteer study | 
| Oxygen Saturation | Did the novel system increase oxygen saturation? | Continuously throughout 30 minute volunteer study |
Willebrand International Non-interventional Global Surveillance

Study Overview
=================
Brief Summary
-----------------
Collect information about WILLFACT or WILFACTIN in their real life clinical use and identify the therapeutic practices in an international environment.

Detailed Description
-----------------
Non-interventional, prospective, non comparative, international, multicentre study.

Official Title
-----------------
International Post-Marketing Surveillance of Willfact-Wilfactin in Patients With Inherited Von Willebrand Disease.

Conditions
-----------------
Von Willebrand Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with inherited von Willebrand disease Patients treated with WILLFACT or WILFACTIN Patient or parent/legal representative who has provided written signed and dated informed consent before any data collection. Exclusion Criteria: Patients who usually do not keep injection log up to date, when treated.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Von Willebrand factor deficient patient<br>Inherited von Willebrand disease | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Documentation of product consumption data | Product consumption (VWF International Units) by analysis of posology, frequency in relation to the severity of bleeding, type of surgery and other clinical situations. | at each follow-up visit, up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection and analysis of adverse events and VWF immunological safety | Adverse event (type, seriousness, severity, frequency, outcome), anti VWF-antibody and anti FVIII-antibody. | at each follow-up visit, up to 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inherited, Von Willebrand disease, Von Willebrand factor, Deficiency, safety
Prospective Observational Study for the Evaluation of VEOFIX Varisation Staples

Study Overview
=================
Brief Summary
-----------------
This clinical investigation was led as a post-market clinical follow-up study (post-market device development stage). Therefore, its objectives were as follows: To assess functional clinical score's evolution, To evaluate patient's satisfaction To confirm safety of varisation staples The target population for this study was any adult patient implanted with VEOFIX varisation staples in their intended uses between 15/02/2021 and 15/05/2021. Patients were implanted and followed as per standard of care led in the investigational site. The following regulation and guidelines were followed for this investigation: Standard ISO 14155:2020 Good Clinical Practiceundirectly applicable; Regulation (UE) 2016/679 (RGPD) ; Regulation (UE) 2017/745 (MDR) ; MEDDEV 2.12.1; Local regulation (loi  jardé , loi  informatique et libertés ). As per its design, the investigation is considered as involving human beings, and therefore require submission to an ethic committee or declaration to a Competent Authority (ANSM) and CPP. This study was registered on CPP (CPP Ile de France VII).

Official Title
-----------------
Prospective Observational Study for the Evaluation of VEOFIX Varisation Staples

Conditions
-----------------
Hallux Valgus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Man or woman Major patient on the date of surgery Patient with foot pathology requiring Akin osteotomy Patient not opposed to the collection of data Exclusion Criteria: Patient unable to understand and follow the postoperative instructions Patient with a contraindication to the use of the implant Non-implanted patient with a varisation staple

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 |
| --- | --- | --- |
| AOFAS Score | To confirm the performance of varisation staples in conservative surgery of Hallux Valgus, according to the indications covered by the CE Marking (Akin's osteotomy) and according to the surgeon's current practice investigator. | 3 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | The information will be collected from both the patient through questionnaires to compare preoperatively situtation to last follow-up situtation | 3 and 12 months | 
| Every complication observed during the investigation is collected |  | 3 and 12 months |
Is wGRS Associated With DD Recurrence?

Study Overview
=================
Brief Summary
-----------------
Rationale: Retrospectively reviewing the participants of the GODDAF database, revealed a significant association between the weighted genetic risk score and Dupuytren disease recurrence. However, a significant dose-response relation was not found. This might be caused by underestimating the recurrence rate, due to the retrospective nature of determining recurrence. Therefore, we want to do a follow-up measurement of the GODDAF participants, to see whether they suffered from recurrent disease. Objective: We aim to determine whether the wGRS is associated with recurrent DD. Study design: An observational study, in which the participants of the GODDAF study are followed up. Study population: Patients affected by Dupuytren disease, aged 18-96 years, who were previously included in another study on the genetic basis of Dupuytren disease. Intervention (if applicable): NA Main study parameters/endpoints: The main study parameter is the presence of recurrent Dupuytren disease.

Official Title
-----------------
Is the Weighted Genetic Risk Score Associated With Dupuytren Disease Recurrence?

Conditions
-----------------
Dupuytren Contracture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DD patient participant in the GODDAF study genetic data passed the quality control surgical treatment of DD written informed consent Exclusion Criteria: Decisionally incapacitated Patients treated for DD with collagenase or radiotherapy

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 |
| --- | --- | --- |
| Presence of recurrent Dupuytren disease | there is only one measurement in this study | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of Dupuytren recurrence | there is only one measurement in this study | 1 day |
Proposal of a Score to Detect the Need for Postoperative Intensive Care Unit Admission After Bariatric Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to propose a multi-dimensional score to predict those patients undergoing bariatric surgeries who will be in need for postoperative ICU admission.

Detailed Description
-----------------
A multi-dimensional score of 7 risk factors was proposed which may help in identifying morbidly obese patients undergoing bariatric surgeries who will need admission to a critical care unit postoperatively for follow up.

Official Title
-----------------
Proposal of a Score to Detect the Need for Postoperative Intensive Care Unit Admission After Bariatric Surgery

Conditions
-----------------
Bariatric Surgery Procedures

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who have been operated upon for either laparoscopic gastric sleeve or laparoscopic gastric bypass during the period from January to June 2016. Exclusion Criteria: Patients were excluded in case of postoperative surgical complications, conversion to open surgery or in case of redo.

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
| Creation of a multi-dimensional score for the need of post-bariatric surgery ICU admission |  | Through study completion, an average of six months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bariatric surgery, Multi-dimensional score, Morbid obesity
Multiple Arm Study of Sebacia Microparticles in the Treatment of Acne Vulgaris

Study Overview
=================
Brief Summary
-----------------
Prospective, multicenter study with multiple arms to examine the safety and effectiveness of the Sebacia Acne Treatment System for the treatment of acne vulgaris.

Official Title
-----------------
A Feasibility Study to Evaluate the Safety and Preliminary Efficacy of the Sebacia Acne Treatment System for the Treatment of Acne Vulgaris

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Device: Sebacia microparticle and laser treatment
* Device: Vehicle and laser treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of moderate to severe acne vulgaris Exclusion Criteria: use of oral retinoid therapy in the past 12 months pregnancy, lactating, or planning to become pregnant excessive scarring in the treatment area, or other condition that would impact the ability to evaluate acne

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 35 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: Sebacia microparticle and laser treatment<br> | Device: Sebacia microparticle and laser treatment<br> <br> |
| Sham Comparator: Vehicle and laser treatment<br> | Device: Vehicle and laser treatment<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in inflammatory lesion count |  | Week 12 | 
| Number of adverse events |  | Screening to 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Global Assessment |  | Week 12 |