linjc16/ctgov huggingface dataset:
Assessment of the New Lateral Sinus Floor Elevation Technique Using Piezosurgery: A Clinical and Radiographic Retrospective Study

Study Overview
=================
Brief Summary
-----------------
All patients who received lateral sinus floor elevation using this new piezosurgery technique, were selected. The personal file of each patient was retrieved and the following data were taken: age, sex, smoking habits, occurrence of per-operative complications (mucosal perforation, hemorrhage) and post-operative infectious complications. Pre-operative CBCT of included patients were all performed using the same Newtom VGI radiographic machine and collected from the radiology unit at the Faculty of Dental Medicine at Saint Joseph University of Beirut. The measurement of the studied factors was performed on Newtom VGI viewer software, by two evaluators J.B. and A.M.

Official Title
-----------------
Assessment of the New Lateral Sinus Floor Elevation Technique Using Piezosurgery: A Clinical and Radiographic Retrospective Study

Conditions
-----------------
Lateral Sinus Lift, Per-operation Complications

Intervention / Treatment
-----------------
* Other: Complication


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who received lateral sinus floor elevation using this new piezosurgery technique. Exclusion Criteria: the usual exclsion criteria for external sinus lift procedure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 74 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 |
| --- | --- |
| Per-operative Complication<br> | Other: Complication<br>* whether or not complications occur<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative complication | We will monitor the prevalence of membrane perforation during external sinus lift procedure | During surgical procedure |
Tirbanibulin 1% Ointment for the Treatment of Chronically Sun-damaged Skin on the Face

Study Overview
=================
Brief Summary
-----------------
Interventional, monocentric, national, single-arm, uncontrolled, open, prospective phase IV study. Since this study is not powered for confirmative testing, analysis is done by descriptive statistics Eligible AK patients receive Tirbanibulin on sun-damaged areas of the face for five days, according to the SmPC. Diagnosis and monitoring of treatment effects are supported by UV imaging using Canfield VISIA®. Safety and efficacy are assessed at end of treatment visit (EoT, approximately 3 days after the last dose, i.e, day 8 ± 2) and at a follow-up visit (FuV) 57 ± 7 d after the start of the treatment. UV images (Canfield VISIA®) will be taken at baseline, EoT and FuV, accompanied by conventional dermatological assessment according to clinical routine.

Official Title
-----------------
Tirbanibulin 1% Ointment for the Treatment of Chronically Sun-damaged Skin on the Face

Conditions
-----------------
Actinic Keratosis

Intervention / Treatment
-----------------
* Drug: Tirbanibulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent Diagnosed with sun-damaged skin on the face and AK in the treatment area Willing and able to comply with all study procedures Use of medically acceptable contraception in males or females of child-bearing potential 51 -100 years of age Negative pregnancy test at baseline in females of childbearing potential Exclusion Criteria: Allergy or intolerance towards the active ingredient or any of the constituents of the IMP Any contraindication for the IMP, according to the most recent version of the SmPC Open lesions of any kind on the face Concomitant cutaneous malignancy in treatment area, including but not restricted to squamous skin cancer Immune deficiency Participation in another clinical trial during the last six months Pregnancy or lactation
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: Treatment<br> | Drug: Tirbanibulin<br>* Klisyri® 10 mg/g Ointment (Tirbanibulin) patients receive Tirbanibulin on sun-damaged areas of the face for five days, according to the SmPC.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unmasking of subclinical lesions in UV-exposed areas of chronically sun-damaged skin of the face by a treatment with Tirbanibulin. | Total clearance rates of unmasked lesions 57± 7 days after the start of the treatment. | 57± 7 days |
Kerecis Fish Skin Grafts With and Without Platelet Rich Plasma (PRP)

Study Overview
=================
Brief Summary
-----------------
This prospective, randomized pilot study compares the use of a xenograft with PRP to a xenograft alone for chronic, nonhealing wounds.

Official Title
-----------------
Fish Skin Grafts With Platelet-rich Plasma Compared to Fish Skin Grafts for Chronic Wound Healing: Randomized, Prospective Trial

Conditions
-----------------
Non-healing Wound

Intervention / Treatment
-----------------
* Other: Platelet Rich Plasma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is over the age of 18 years; The targeted wound is deemed a chronic, nonhealing wound after six weeks of treatment; - - Patient of Dr. Eldridge, Dr. Glenn, or Dr. Worley; Target wound size must be between 2 cm x 2 cm x 0.1 cm deep and 10 cm x 10 cm x 5 cm deep; Surgical candidate for standard of care Kerecis® xenograft surgery. Exclusion Criteria: Patient with hemoglobin values less than 6.9 g/dL drawn at least 30 days prior to the Kerecis® xenograft surgery; Patient with a known allergy or other sensitivity to fish material; Patient is currently undergoing chemotherapy or radiation therapy; The targeted wound is of autoimmune origin; and Non-English-speaking patients.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study will be a 1:1 randomized controlled trial with parallel group assignment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Xenograft only<br>The Kerecis® xenograft (Kerecis® Omega3 MariGen) will be applied without the application of PRP. | |
| Experimental: Xenograft and PRP<br>The Kerecis® xenograft (Kerecis® Omega3 MariGen) will be applied with the application of PRP. | Other: Platelet Rich Plasma<br>* Platelet rich plasma will be applied to assess rate of wound healing.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to wound being deemed healed or 6 months | Assessed by time, surface area of wound, wound volume and relative surface size | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound quality of life | The Wound-QoL-14 questionnaire on quality of life with chronic wounds will be used to assess changes in score prior to initial application of xenograft or xenograft/PRP to time of wound healing or 6 months, whichever comes first. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
xenograft, PRP, platelet rich plasma
Retrospective Evaluation of SuperSaturated Oxygen (SSO2) Therapy Clinical Utility

Study Overview
=================
Brief Summary
-----------------
The purpose of this multicenter study is to assess the impact of SSO2 treatment on clinical outcomes and left ventricular function in patients following acute ST-segment elevation myocardial infarction (STEMI).

Detailed Description
-----------------
The TherOx® Downstream® System, which is approved for use in the United States (US) by the Food and Drug Administration (FDA) under P170027. The TherOx® Downstream® System consists of three primary components. These include a hardware device called the TherOx Downstream System (console), a single-use disposable device called the TherOx Downstream Cartridge (cartridge) and a 5 French, commercially available qualified SSO2 infusion coronary delivery catheter (delivery catheter). This is a multicenter, retrospective case-control study which will collect data from all STEMI patients who received SSO2 treatment at participating centers, along with up to 3 matched control patients who did not receive SSO2 treatment.

Official Title
-----------------
Retrospective Evaluation of SuperSaturated Oxygen (SSO2) Therapy Clinical Utility (RESCU). An Analysis of Clinical Outcomes and Left Ventricular Recovery of STEMI Patients Treated With SSO2 Therapy After Primary Percutaneous Coronary Intervention (PPCI)

Conditions
-----------------
Acute ST Segment Elevation Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Data from all patients who received SSO2 treatment and have completed a minimum of 3 months follow up will be collected at each participating center; there are no other exclusion criteria aside from date of treatment. Exclusion Criteria: -

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Minneapolis Heart Institute<br> | |
| The Feinstein Institutes for Medical Research<br> | |
| NCH Baker Downtown Hospital<br> | |
| OhioHealth Research Institute<br> | |
| Baptist Health Baptist Hospital<br> | |
| St. Mary's Medical Center<br> | |
| Corewell Health William Beaumont University Hospital - Research Institute<br> | |
| University of Chicago Medicine<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Left Ventricular Ejection Fraction | Between group comparison | Baseline to 3 months | 
| Rate of Cardiovascular related Hospitalizations | Between group comparison | Through study completion, an average of 1 year |
Automated Imaging Differentiation of Parkinsonism

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the performance of the AID-P across 21 sites in the Parkinson Study Group. Each site will perform imaging, clinical scales, diagnosis, and will upload the data to the web-based software tool. The clinical diagnosis will be blinded to the diagnostic algorithm and the imaging diagnosis will be compared to the movement disorders trained neurologist diagnosis.

Official Title
-----------------
Automated Imaging Differentiation of Parkinsonism

Conditions
-----------------
Multiple System Atrophy, Parkinson Variant, Progressive Supranuclear Palsy, Parkinson Disease

Intervention / Treatment
-----------------
* Diagnostic Test: AIDP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parkinson's disease diagnosis within 5-9 years of baseline date MSAp diagnosis PSP diagnosis Exclusion Criteria: metal implants in the body that preclude an MRI (pacemaker, metallic clip, neurostimulator, etc) claustrophobia pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 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 |
| --- | --- |
| Parkinson's disease<br>Clinically diagnosed Parkinson's disease | Diagnostic Test: AIDP<br>* Machine learning algorithm of imaging data<br>|
| Multiple System Atrophy, Parkinsonian variant<br>Clinically diagnosed Multiple System Atrophy, Parkinsonian variant | Diagnostic Test: AIDP<br>* Machine learning algorithm of imaging data<br>|
| Progressive Supranuclear Palsy<br>Clinically diagnosed Progressive Supranuclear Palsy | Diagnostic Test: AIDP<br>* Machine learning algorithm of imaging data<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predicted diagnosis accuracy | utilizing the automated imaging differentiation of Parkinsonism (AIDP) tool to predict diagnosis compared to the expertise of two movement disorder specialists | 12-18 months |
Prevalence of Cardiac Amyloidosis Among Patients With a History of Lumbar Spinal Stenosis.

Study Overview
=================
Brief Summary
-----------------
The study investigates the prevalence of cardiac amyloidosis among patients with a history of lumbar spinal stenosis within the last ten years in the region of central Denmark.

Official Title
-----------------
Prevalence of Cardiac Amyloidosis Among Patients With a History of Lumbar Spinal Stenosis.

Conditions
-----------------
Cardiac Amyloidosis, Spinal Stenosis

Intervention / Treatment
-----------------
* Diagnostic Test: DPD scintigraphy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of lumbar spinal stenosis. Age > 60 years at the time of spinal stenosis surgery. Written informed consent. Exclusion Criteria: Known amyloidosis Myelomatosis Monoclonal gammopathy of unknown origin, MGUS Morbus Waldenstrøm

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Patients with a history of lumbar spinal stenosis. | Diagnostic Test: DPD scintigraphy<br>* Bone tracer scintigraphy, diagnostic for transthyretin amyloidosis.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of cardiac amyloidosis | DPD scintigraphy with a Perugini Grade 2 og higher. | 1 year |
Clinical Significance and Coexistence of Polymorphisms of Individual Collagen-coding Genes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess correlation between recurrent patella dislocation and genetic polymorphism rs1800012 of the COL1A1 Gene and rs12722 of the COL5A1 Gene.

Detailed Description
-----------------
After being informed about the study and potential risk all of participants were performed phisical examination and genetic test. In the study we established two groups: In first group- 50 patients with recurrent patellar dislocation and without any genetic disorders. In the second one 200 patients without recurrent patellar dislocation and genetic disorders. All pediatric patients were between 7 and 17 years old in two groups respectivly.

Official Title
-----------------
Clinical Significance and Coexistence of Polymorphisms of Individual Collagen-coding Genes - rs1800012 of the COL1A1 Gene and rs12722 of the COL5A1 Gene in Patellar Instability in Children.

Conditions
-----------------
Ligament; Laxity, Recurrent Patellar Dislocation

Intervention / Treatment
-----------------
* Diagnostic Test: genetic test
* Other: Beighton joint laxity test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • First-time diagnosed or recurrent patellar dislocation patient from 7 to 17 age years old. Exclusion Criteria: Patient's age under 7. Presence of genetic diseases such as: Down's syndrome or Marfan's syndrome. Metabolic disorders. Previous knee surgeries. Cartilage and bone fractures in the knee. No consent for examination from the legal guardian.

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 17 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 |
| --- | --- |
| Recurrent patellar dislocation group<br>50 patients with recurrent patellar dislocation and without any genetic disorders. | Diagnostic Test: genetic test<br>* COL1A1 or COL5A1 genetic test<br>Other: Beighton joint laxity test<br>* Based on Beighton scale.<br>|
| Patients without joint hipermobility<br>200 patients without recurrent patellar dislocation and genetic disorders. | Diagnostic Test: genetic test<br>* COL1A1 or COL5A1 genetic test<br>Other: Beighton joint laxity test<br>* Based on Beighton scale.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients with recurrent patellar dislocation | Patients with recurrent patellar dislocation | 2022-2023 | 
| Control group without obvious joint hipermobility | Control group without obvious joint hipermobility | 2022-2023 |
Postmarketing Surveillance Study for Quadrivalent Influenza Vaccine (VaxigripTetra®) in Subjects Aged 6 to 35 Months

Study Overview
=================
Brief Summary
-----------------
Multi-center, observational, active safety surveillance study in participants aged 6 to 35 months in Korea under routine clinical practices.

Detailed Description
-----------------
The planned duration of each participant's participation in the study will be 21 to 28 days.

Official Title
-----------------
Post-marketing Surveillance Study for the Use of VaxigripTetra®, a Quadrivalent Influenza Vaccine Administered Via Intramuscular Route in Subjects Aged 6 to 35 Months in Republic of Korea

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Biological: VaxigripTetra®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 6 to 35 months on the day of enrolment Informed consent form has been signed and dated by the parent or other legally acceptable representative Receipt of one dose of VaxigripTetra® on the day of inclusion in routine practice according to the approved local product insert Exclusion Criteria: - Participation at the time of study enrolment (or in the 4 weeks preceding the enrolment) or planned participation during the present study period in a clinical study investigating a vaccine, drug, medical device, or medical procedure

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 35 Months

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: VaxigripTetra®|Suspension for injection Injection intramuscular|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of solicited injection site or systemic reactions | Percentage of participants reporting injection site reactions: pain, erythema, swelling, induration, ecchymosis systemic reactions for infants and toddlers ≤ 23 months: fever, vomiting ,crying abnormal, drowsiness, appetite lost, irritability systemic reactions for children aged 2 to 3 years: fever, headache, malaise, myalgia, shivering | Up to 7 days after vaccination | 
| Occurence of unsolicited adverse events (AEs) | Percentage of participants with unsolicited (spontaneously reported) injection site reactions occurring within 28 days after each injection and unsolicited systemic AEs between each injection and up to 28 days after the last injection | Up to 21(+7) days after vaccination | 
| Occurrence of serious adverse events (SAEs) throughout the study participation | Percentage of participants with SAEs, including AESIs, throughout the study | Up to 21(+7) days after vaccination |
Fusobacterium Nucleatum at Colorectal Cancer Sites

Study Overview
=================
Brief Summary
-----------------
Recent studies suggest an association of periodontitis with an overall increased cancer risk but also with cancer development in specific anatomic regions, such as in the colon. The gut microbiome in general and specifically Fusobacterium nucleatum have been described to likely affect colorectal cancer (CRC) development. The present project intends to evaluate the possible contribution of the oral cavity as a reservoir for dissemination of F.nucleatum to the colon. Additionally, the gut microbiome and dietary intake will be assessed as possible factors influencing colonization of CRC sites with F. nucleatum and an association of F.nucleatum colonization in the colon with parameters in the saliva and serum will be tested. One-hundred-fifty patients diagnosed with CRC will be included; after cancer diagnosis and before starting cancer treatment a periodontal examination will be done and saliva and serum samples and at the time-point of tumor resection a biopsy of the CRC sites will be collected.

Official Title
-----------------
Presence of Fusobacterium Nucleatum at Colorectal Cancer Sites - Influencing Factors and Screening Possibilities

Conditions
-----------------
Colorectal Cancer, Periodontitis

Intervention / Treatment
-----------------
* Other: biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of colorectal cancer

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: biopsy|biopsy of a colorectal cancer site|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of F.nucleatum in a colon cancer biopsy | dichotomous (present / absent) | At timepoint of biopsy |