linjc16/ctgov huggingface dataset:
Peri-implantitis Between Periodontitis and Nonperiodontitis Sites With ARP

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to compare the prevalence of peri-implantitis between periodontitis and nonperiodontitis sites treated with alveolar ridge preservation. The main question it aims to answer is: • whether the occurrence of PI is associated with reasons for dental extraction because of periodontitis and nonperiodontitis after alveolar ridge preservation. Researchers will compare the prevalence of peri-implantitis between periodontitis and nonperiodontitis sites treated with alveolar ridge preservation.

Official Title
-----------------
Prevalence of Peri-implantitis Between Periodontitis and Nonperiodontitis Sites Treated With Alveolar Ridge Preservation: A Retrospective Cohort Study

Conditions
-----------------
Peri-Implantitis

Intervention / Treatment
-----------------
* Procedure: alveolar ridge preservation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria patients aged ≥ 20 years patients who required tooth extraction and implant therapy at least two bite-wing radiographs: baseline and at least a 6-month follow-up Exclusion Criteria a medical condition as a contraindication to dental surgery, autoimmune disorder, immunosuppression, or uncontrolled diabetes (HbA1c > 7%); ong-term nonsteroidal anti-inflammatory drug use oral bisphosphonate therapy pregnancy or lactation the absence of follow-up bite-wing radiograph cigarette consumption >10 per day a history of head and neck radiotherapy.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: alveolar ridge preservation|bone grafting at extracted sites|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of peri-implantitis | bone loss at implant sites | 2013-2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
peri-implantitis, periodontitis, alveolar ridge preservation
SVP Detection Using Machine Learning

Study Overview
=================
Brief Summary
-----------------
This diagnostic study will use 410 retrospectively captured fundal videos to develop ML systems that detect SVPs and quantify ICP. The ground truth will be generated from the annotations of two independent, masked clinicians, with arbitration by an ophthalmology consultant in cases of disagreement.

Official Title
-----------------
Automated Detection of Spontaneous Venous Pulsations Within Fundal Videos Using Machine Learning

Conditions
-----------------
Intracranial Pressure Increase

Intervention / Treatment
-----------------
* Diagnostic Test: Machine Learning Model


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged ≥18 years with presumed normal ICP undergoing routine dilated OCT scans. Patients undergoing a LP or continuous ICP monitoring with implanted transcranial pressure transducer devices at in- or out-patient neurology, neurosurgery or neuro-ophthalmology services. Exclusion Criteria: Glaucoma diagnosis or glaucoma suspects in either eye. Bilateral restricted fundal view, e.g. advanced bilateral cataracts. Bilateral retinal vein or artery occlusion.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients aged ≥18 years with presumed normal intracranial pressure<br> | Diagnostic Test: Machine Learning Model<br>* Automated machine learning system for the detection of spontaneous venous pulsations and quantification of intracranial pressure<br>|
| Patients aged ≥18 years with suspected raised intracranial pressure<br> | Diagnostic Test: Machine Learning Model<br>* Automated machine learning system for the detection of spontaneous venous pulsations and quantification of intracranial pressure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area-under-the receiver operating characteristic (AUROC) for spontaneous venous pulsations detection | Binary classification performance of the machine learning model | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Localisation of spontaneous venous pulsations | Bounding box overlap for the machine learning model | 1 year | 
| Quantification of intracranial pressure | Mean absolute error for the prediction of the intracranial pressure | 1 year |
Comparison of ASA and CFS in Anesthesiology

Study Overview
=================
Brief Summary
-----------------
In addition to the regular ASA classification, patients would also be assigned the Clinical frailty scale (CFS) during preoperative examinations in anesthesiology clinics. The aim is to compare the usefulness of ASA and CFS categorization for predicting perioperative and postoperative complications and length of postoperative stay in elective surgeries.

Detailed Description
-----------------
CFS significantly correlates with complications in patients treated in emergency department. This study is expected to provide information on how CFS correlates with complications and length of stay in elective surgeries. In addition to the regular ASA classification, patients would also be assigned the Clinical frailty scale (CFS) during preoperative examinations in anesthesiology clinics. The respondents are all elective patients over 65 years of age who have not had previously recorded mental difficulties that interfere with their daily life. Patients suffering from senile dementia would not be excluded from this study. After the treatment was completed, the medical history of each patient would be reviewed and statistically processed. The aim is to compare the usefulness of ASA and CFS categorization for predicting perioperative and postoperative complications and length of postoperative stay in elective surgeries.

Official Title
-----------------
Comparison of ASA and CFS in Predicting Peri- and Postoperative Outcomes in Elective Patients Older Than 65 Years

Conditions
-----------------
Frailty

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All elective patients older then 65 years Exclusion Criteria: Earlier mental difficulties that affect everyday life, senile dementia is not exclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- | --- |
| Peri- and postoperative complications | Peri- and postoperative complications depending on CFS and ASA | During 2 months after elective operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay in hospital | Length of stay in hospital after elective operation depending on CFS and ASA | During 2 months after elective operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Elderly, American Society of Anesthesiologists physical status;, Clinical frailty, Treatment outcome
The Distribution of Immunoglobulin Isotype in Polyclonal Hypergammaglobulinemia in Systemic and Autoimmune Diseases

Study Overview
=================
Brief Summary
-----------------
Polyclonal hypergammaglobulinaemia is characterized by increased levels of immunoglobulins and is a common feature observed in various diseases such as autoimmune diseases, chronic infectious diseases or lymphoid hemopathy. Some autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis or Sjögren's syndrome are frequently associated with polyclonal hypergammaglobulinaemia. Recent data have suggested that the distribution of immunoglobulin isotypes in polyclonal hypergammaglobulinaemia may be disease-specific. However, isotype repartition in polyclonal hypergammaglobulinaemia remains poorly understood. The investigators will investigate the distribution of immunoglobulin isotype in patients with autoimmune disease and polyclonal hypergammaglobulinaemia. Moreover, the investigators will evaluate the isotype repartition as predictor of lymphoma or monoclonal gammopathy among patients with autoimmune diseases.

Official Title
-----------------
The Distribution of Immunoglobulin Isotype in Polyclonal Hypergammaglobulinemia in Systemic and Autoimmune Diseases

Conditions
-----------------
Polyclonal Hypergammaglobulinemia, Autoimmune Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adult patients > 18 years old patients with one of the following diseases: systemic lupus erythematosus, rheumatoid arthritis, Sjögren's syndrome, autoimmune hepatitis, sarcoidosis or lymphoma. Exclusion Criteria: Age < 18 years; chronic viral hepatitis; HIV infection, syphilis, tuberculosis

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 |
| --- | --- | --- |
| distribution of immunoglobulin isotypes | distribution of immunoglobulin isotypes in polyclonal hypergammaglobulinaemia associated with autoimmune and systemic diseases (systemic lupus erythematosus, rheumatoid arthritis, Gougerot-Sjögren syndrome, sarcoidosis) | one day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Polyclonal Hypergammaglobulinemia, Autoimmune Diseases, immunoglobulin isotypes
Study of Progression to Progressive Fibrosing Interstitial Lung Disease (PF-ILD) Incidence/Management and Treatment

Study Overview
=================
Brief Summary
-----------------
The primary objective for this trial is to investigate the incidence probability of progression to Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs) in patients with fibrosing ILD other than Idiopathic Pulmonary Fibrosis (IPF) in real-world setting in Japan. The secondary objective is to investigate the characteristics of procedures for management and treatment in patients with fibrosing ILD other than IPF in real-world setting in Japan.

Official Title
-----------------
Incidence Probability of Progression to Progressive Fibrosing Interstitial Lung Diseases and Status of Management and Treatments in Patients With Fibrosing Interstitial Lung Diseases Other Than Idiopathic Pulmonary Fibrosis in Japan

Conditions
-----------------
Lung Diseases, Interstitial

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with at least two fibrosing Interstitial Lung Disease (ILD) codes on different dates in the patient identification period Patients aged 18 years and older on the index date Patients for whom data for the 12 months prior to the index date can be extracted as baseline data Exclusion Criteria: Patients grouped into the underlying disease of Idiopathic Pulmonary Fibrosis (IPF) Patients who have met PF-ILD progression criteria during the baseline period

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 with fibrosing interstitial lung disease (ILD)<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence probability of progression to PF-ILDs |  | up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequeny of patients with treatment of interest | e. g. with corticosteroids or immunosuppressive drugs | up to 7 years + 5 months | 
| Frequency of patients with Disease Management of interest | e. g. Oxygen therapy, Lung transplant, Palliative care | up to 7 years + 5 months |
Drug-drug Interactions Between DWC202211 and DWC202212 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
An open-label phase 1 study to evaluate pharmacokinetic/pharmacodynamic drug-drug interactions and safety/tolerability of DWC202211 and DWC202212 compared to coadministration in healthy

Official Title
-----------------
An Open-label Phase 1 Study to Evaluate Pharmacokinetic/Pharmacodynamic Drug-drug Interactions and Safety/Tolerability of DWC202211 and DWC202212 Compared to Coadministration in Healthy

Conditions
-----------------
Drug-drug Interaction

Intervention / Treatment
-----------------
* Drug: DWC202211 100mg
* Drug: DWC202212 5mg
* Drug: DWC202211 100mg + DWC202212 5mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adults aged ≥ 19 and ≤ 50 years at screening Subjects with a body weight ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 to ≤ 27.0 kg/m2 at screening ※ BMI (kg/m2) = body weight (kg)/[height (m)]2 Subjects who voluntarily decided to participate in the study and provided written consent to follow precautions after receiving a sufficient explanation on this study and fully understanding the information Subjects who are eligible to participate in the study at the discretion of the investigator by physical examination, laboratory tests, and investigator questioning, etc.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DWC202211<br> | Drug: DWC202211 100mg<br>* DWC202211 for 5 days Aspirin 100mg<br>|
| Experimental: DWC202212<br> | Drug: DWC202212 5mg<br>* DWC202212 for 3 days Rabeprazole 5mg<br>|
| Experimental: DWC202211 + DWC202212<br> | Drug: DWC202211 100mg + DWC202212 5mg<br>* DWC202211 + DWC202212 for 5 days Aspirin 100mg, Rabeprazole 5mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax |  | up to 27 days | 
| AUClast |  | up to 27 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DWC202211 Tmax,ss |  | up to 27 days | 
| DWC202211 T1/2,ss |  | up to 27 days | 
| DWC202211 Cmin,ss |  | up to 27 days | 
| DWC202211 Cavg,ss |  | up to 27 days | 
| DWC202211 CLss/F |  | up to 27 days | 
| DWC202211 Vdss/f |  | up to 27 days | 
| DWC202211 PTF |  | up to 27 days | 
| DWC202212 Tmax,ss |  | up to 27 days | 
| DWC202212 T1/2,ss |  | up to 27 days | 
| DWC202212 Cmin,ss |  | up to 27 days | 
| DWC202212 Cavg,ss |  | up to 27 days | 
| DWC202212 CLss/F |  | up to 27 days | 
| DWC202212 Vdss/f |  | up to 27 days | 
| DWC202212 PTF |  | up to 27 days |
User Evaluation of BGM JS200B

Study Overview
=================
Brief Summary
-----------------
Performance Evaluation by the User of the Blood Glucose Monitoring System JS200B in accordance with DIN EN ISO 15197:2015

Official Title
-----------------
Evaluierung Des Blutglukose Monitoring Systems JS200B Der Firma TysonBio gemäß DIN EN ISO 15197:2015

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Diagnostic Test: blood glucose measurement by subject
* Diagnostic Test: blood glucose measurement with reference


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Male or female patients with hypo-, eu- or hyperglycaemia The written informed consent had to be signed The volunteers must be older than 18 years The volunteers have legal capacity and are able to understand meaning, nature and possible consequences of the procedures involved Exclusion criteria: Pregnancy or lactation Acute or chronic diseases with the risk of aggravation by the measure A current constitution that does not allow participating in the study Participation in another study or activity with the blood glucose measuring system evaluated in the present study Application of substances listed in Appendix A of DIN EN ISO 15197:2015

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: Subject glucometer measurement<br>Blood glucose measurement BGM for personal use | Diagnostic Test: blood glucose measurement by subject<br>* blood glucose measurement by subject using finger tip capillary blood<br>Diagnostic Test: blood glucose measurement with reference<br>* blood glucose measurement with reference method using finger tip capillary blood<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of system accuracy based on DIN EN ISO 15197 | Assessment of the analytical measurement performance of the blood glucose monitor | Day 1 |
EVEREST-HN 1: EVolution of a patiEnt-REported Symptom-based Risk Stratification sySTem

Study Overview
=================
Brief Summary
-----------------
Can a patient-reported symptom-based risk stratification system improve the suspected head and neck cancer (HNC) pathway? Our methodology includes six interlinked work packages to deliver our aim, with EVEREST-HN 1 encompassing the first of these and seeking to optimise a patient-reported symptom inventory for HNC and outline requirement specification for the SYmptom iNput Clinical (SYNC) system.

Detailed Description
-----------------
The EVEREST-HN pathway should be based on a comprehensive understanding of existing HNC diagnostic pathways and what patients and clinicians value in these. The language used within the EVEREST pathway needs to be accessible and optimal to elicit appropriate information.

Official Title
-----------------
EVolution of a patiEnt-REported Symptom-based Risk Stratification sySTem to Redesign the Suspected Head and Neck Cancer Referral Pathway (Phase 1)

Conditions
-----------------
Head and Neck Cancer

Intervention / Treatment
-----------------
* Other: No intervention.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients: Adults ≥ 18 years referred via suspected HNC pathway without previous history of HNC Participants willing and able to give informed consent for participation in the study. Clinicians: Staff at participating sites involved in the diagnostic pathway for people with suspected HNC. Exclusion Criteria: Individuals who do not meet the inclusion 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<br>Approximately 150 adults referred for suspected HNC will be recruited. | Other: No intervention.<br>* No intervention.<br>|
| Staff<br>Approximately 15 ENT and Maxillofacial) clinicians will be recruited. | Other: No intervention.<br>* No intervention.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inventory and specification for the SYmptom iNput Clinical (SYNC) system | To optimise a patient-reported symptom inventory for HNC and outline requirement specification for the SYmptom iNput Clinical (SYNC) system | September 2022 - August 2023 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To further explore the current suspected HNC pathway and the language used when discussing symptoms. | To understand how clinicians decide subsequent steps for patients referred with suspected HNC, the language patients and clinicians use to describe symptoms and patients' and clinicians' views and experiences of the current diagnostic process for HNC. with a focus on what would work for EVEREST-HN study. | September 2022 - August 2023 |