linjc16/ctgov huggingface dataset:
A New Mutational and Epigenetic Signature to Predict Early OPSCC Relapse

Study Overview
=================
Brief Summary
-----------------
Inclusion of new biomarkers to improve the personalized treatment approach for HPV-positive and -negative oropharyngeal squamous cell carcinoma (OPSCC) patients is urgently needed. Emerging evidences suggest that mutations in epigenetic regulators, as well as epigenetic changes, deeply influence the biology of OPSCC, thus representing attractive targets for the definition of novel molecular markers for this malignancy. Based on these considerations, our project aims to retrospectively identify a new mutational and epigenetic signature to identify OPSCC patients at high risk of early relapse, and to set up a new multicenter prospective study in order to validate it

Official Title
-----------------
A New Mutational and Epigenetic Signature to Predict Early OPSCC Relapse

Conditions
-----------------
Oropharyngeal Squamous Cell Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: newly diagnosed, previously untreated, histologically confirmed stage III-IVa OPSCC, according to AJCC 7th Edition, managed with definitive treatment modality (either radical surgery plus adjuvant radiotherapy ± chemotherapy or definitive chemo-radiotherapy) minimum follow up of 2 years or who had disease recurrence within 2 years after the end of treatment. neoplastic lesion contains ≥ 70% neoplastic cells Exclusion Criteria: Patients: with distant metastases at diagnosis, who have been managed with palliative intent; with previous history of head and neck cancer are not eligible

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| risk of recurrence | risk of recurrence in patients with a negative prognostic epigenetic signature compared to patients with a positive one | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oropharyngeal Squamous Cell Carcinoma
Study of Dengue in Patients With Autoimmune Diseases During the Epidemics of 2020 and 2021 in Reunion Island

Study Overview
=================
Brief Summary
-----------------
It is not known whether there is a different clinical profile of dengue in patients with immune system dysfunction. Preliminary data and previous literature suggest that autoimmune diseases, and in particular their treatment, may favour the evolution to severe forms of dengue. Our research hypothesis is that the clinico-biological presentation of dengue might be different in case of autoimmune disease, either on the side of overactivation (autoimmune and auto inflammatory diseases without treatment) or immunodepression (autoimmune and auto inflammatory diseases under immunosuppressive treatment).

Official Title
-----------------
Study of Dengue in Patients With Autoimmune Diseases With or Without Immunosuppressive Treatment During the Epidemics of 2020 and 2021 in Reunion Island

Conditions
-----------------
Dengue

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years Patient with autoimmune or autoinflammatory disease Confirmed diagnosis of dengue (in 2020 or 2021): serological test, antigenic test or PCR test to confirm the diagnosis according to current criteria Exclusion Criteria: minor opposition to the re-use of data patient not followed in Reunion protected adult (guardianship or curatorship) or under legal protection

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 |
| --- | --- | --- |
| To assess the observed severity of dengue in patients with autoimmune/autoinflammatory diseases. | Proportion of severe dengue (WHO 2009 definition) in patients with autoimmune/autoinflammatory disease who contracted dengue in 2020/2021, with 95% confidence interval (CI95%). | Day 1 |
Risk Factors and Prediction Model of Cancer-associated Venous Thromboembolism

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify risk factors of cancer-associated venous thrombosis and develop a prediction model to assist clinicians in tailoring anticoagulant therapy.

Detailed Description
-----------------
Venous thromboembolism (VTE) is a prevalent complication in cancer patients. Compared with the general population, patients with tumors are four to seven times more likely to develop venous thrombotic events. A population-based cohort study showed that the incidence of VTE in these patients has increased steadily over the past decade. Cancer-associated thrombosis may result in discontinuation of antineoplastic therapy, decreased quality of life, and increased mortality. Clinical trials indicate that prophylactic anticoagulation leads to a significantly lower rate of thrombotic disorders. However, due to the fact that thromboprophylaxis treatment increases the risk of bleeding complications and that the risk of VTE varies widely among individuals, only patients at high risk of thrombosis will benefit from primary thromboprophylaxis. In this setting, the use of anticoagulant drugs is challenging. So, the purpose of this study is to identify risk factors of cancer-associated venous thrombosis and develop a prediction model to assist clinicians in tailoring anticoagulant therapy.

Official Title
-----------------
Risk Factors and Prediction Model of Cancer-associated Venous Thromboembolism

Conditions
-----------------
Venous Thromboses, Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: with a histological diagnosis of cancer. Exclusion Criteria: received long-term anticoagulant therapy; without a clear primary site of malignancy; had a follow-up of fewer than 6 months.

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 |
| --- | --- |
| cancer patients with venous thrombosis<br> | |
| cancer patients without venous thrombosis<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cancer-associated venous thrombosis | including deep venous thrombosis and pulmonary embolism | 12 months since receiving anti-cancer therapy |
V-A ECMO AUTO Mode Registry

Study Overview
=================
Brief Summary
-----------------
Abiomed Impella V-A ECMO AUTO Mode - Observational Study

Detailed Description
-----------------
The overall objective of this study is to collect data during routine Impella usage in an ECpella setting to analyze and assess potential clinical effects, usability, and ease of use of an automated Impella mode to run in conjunction with a VA ECMO system for continued assessment and development of the underlying algorithms in different clinical settings. The primary objective is thus the collection of clinical events to serve as a database for an in-silico post-hoc analysis of the V-A ECMO AUTO Mode algorithm for the Impella pump. This is accompanied by a secondary objective assessing usability, confirming the user friendliness and ease of use by collection of user experience and insights through a questionnaire and data on alarms and manual user interaction with the AIC out of the operational console data.

Official Title
-----------------
Abiomed Impella V-A ECMO AUTO Mode - Observational Study

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: V-A ECMO AUTO Mode algorithm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with ongoing or planned ECpella therapy Exclusion Criteria: Age < 18 years Treatment with other than VA ECMO setup Treatment with Impella CP® heart pump only

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: V-A ECMO AUTO Mode algorithm|The clinical effects of utilizing the V-A ECMO AUTO Mode in parallel with VA ECMO treatment shall be assessed in different clinical settings. For this, a set of relevant clinical situations and findings (events) has been defined as trigger points where technical (via AIC) and clinical data shall be collected, linked, and analyzed. This assessment of raw data is important to further develop and adapt the software.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gather clinical event data | Collection of clinical events to serve as a database for an in-silico post-hoc analysis of the V-A ECMO AUTO Mode algorithm | Until one of the devices is permanently weaned, on average 5 days | 
| Usability assessment | Confirmation of usability and ease of use by collection of user data and operational console data | Until study completion, an average of 1 year |
Lidocaine Combined With Sufentanil for Preventing Catheter-related Bladder Discomfort

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to evaluate the incidence and severity of postoperative catheter-related bladder discomfort after robot-assisted radical prostatectomy. The main question it aims to answer is to evaluate incidence of CRBD immediately after extubation in resuscitation. A total of 20ml of 2% lidocaine and 1μg/ml sufentanil or 20ml normal saline was injected into the bladder of the participants through the catheter. After drug injection, the catheter was clamped for 20 minutes, and then 100ml normal saline was injected into the bladder through the catheter to flush out. Then, the incidence of CRBD was compared between the two groups.

Official Title
-----------------
Lidocaine Combined With Sufentanil for Preventing Catheter-related Bladder Discomfort After Robot-assisted Radical Prostatectomy: a Randomized, Double-blind, Controlled Trial

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: lidocaine and sufentanil
* Drug: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 18-79 years, ASA class I-II participants undergoing robot-assisted radical prostatectomy under general anesthesia signed informed consent and volunteered to participate in the experiment Exclusion Criteria: urethral stricture, difficulty in inserting catheter or urethral bleeding during catheterization a preexisting bladder disease such as an overactive bladder, bladder outflow obstruction, and neurogenic bladder cognitive impairment or communication disorders severe heart, lung, liver, kidney and immune system diseases confirmed or suspected allergy to this trial drug

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine + sufentanil intervention group<br> | Drug: lidocaine and sufentanil<br>* A total of 20ml of 2% lidocaine and 1μg/ml sufentanil was injected into the bladder through the catheter.<br>|
| Placebo Comparator: Saline control group<br> | Drug: Saline<br>* A total of 20ml normal saline was injected into the bladder through the catheter.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of CRBD | incidence of CRBD | immediately after extubation in resuscitation |
Long-Term Follow-up Study of Subjects With Knee Osteoarthritis Who Had Administered FURESTEM-OA Kit Inj. in K0701 Study

Study Overview
=================
Brief Summary
-----------------
Long-Term Follow-up Study of Subjects with Knee Osteoarthritis who had administered FURESTEM-OA Kit Inj. in K0701 study

Official Title
-----------------
Long-Term Follow-up Study of Subjects With Knee Osteoarthritis Who Had Administered FURESTEM-OA Kit Inj. in K0701 Study

Conditions
-----------------
Knee Osteoarthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Those who participated in the K0701 clinical trial and received PureStem-OA Kit Inj Those who understand and voluntarily sign an informed consent form exclusion criteria None

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- | --- |
| Number of AESI |  | 5 years follow-up after treatment | 
| Number of SS |  | 5 years follow-up after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Knee Injury and Osteoarthritis Outcome Score (KOOS) | The higher the score, the worse the condition of the disease is. | 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment | 
| Changes in Western Ontario and McMaster Universities osteoarthritis index (WOMAC) | The WOMAC evaluation is evaluated using the score value converted through the KOOS evaluation paper. | 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment | 
| Changes in 100-mm VAS |  | 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment | 
| Changes in International Knee Documentation Committee Scoring System (IKDC) | A higher score indicates better function and less symptomatic | 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment | 
| Evaluation of International K&L grade(X-ray) | Grade 0 - No radioligical findings of osteoarthritis Grade 1 - Doubtful narrowing of joint space and possible osteophytic lipping Grade 2 - Definite osteophytes and possible narrowing of joint space Grade 3 - Moderate osteophytes, definite narrowing of joint space, and some sclerosis and deformity of bone ends Grade 4 - Large osteophytes, marked narrowing of joint space, severe sclerosis, and definite deformity of bone ends | 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment | 
| Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scores(MRI) | A higher score indicates better function and less symptomatic | 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment | 
| Whole-Organ Magnetic Resonance Imaging Score (WORMS) score | The higher the score means normal state. | 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment |
Assessing the Role of Mitochondrial Dysfunction in Primary Progressive Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this project is to study genetic determinants of mitochondrial impairment in primary progressive multiple sclerosis. Specific aims are: 1) identify mitochondrial-related pathways, inherited and somatic mitochondrial DNA mutations associated to primary progressive multiple sclerosis, 2) functionally assess the identified genetic alterations.

Detailed Description
-----------------
Multiple Sclerosis is a major cause of neurological disability, with a high socio-economic impact that increases as disability progresses. Effective treatment of primary progressive multiple sclerosis is still an unmet need and the underlying neurodegenerative processes have to be fully investigated. The purpose of this project is to study genetic determinants of mitochondrial impairment in primary progressive multiple sclerosis. We will search for altered mitochondrial pathways, as well as inherited and tissue-specific somatic mitochondrial variations associated with primary progressive multiple sclerosis.

Official Title
-----------------
Assessing the Role of Mitochondrial Dysfunction in Primary Progressive Multiple Sclerosis

Conditions
-----------------
Multiple Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients affected by primary progressive or relapsing remitting multiple sclerosis Patient able to provide informed consent Exclusion Criteria: Individuals with < 18 years Patients not affected by primary progressive or relapsing remitting multiple sclerosis

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 |
| --- | --- |
| Primary Progressive multiple sclerosis<br>patients affected by primary progressive multiple sclerosis | |
| Relapsing Remitting multiple sclerosis<br>patients affected by primary progressive multiple sclerosis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sequencing of mitochondrial DNA | the mitochondrial DNA collected from blood and cerebrospinal fluid will be sequenced and analysed, comparing the frequency of variants between the two disease courses | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
multiple sclerosis, mitochondria
Incontinence Analysis After HoLEP Using 28Fr Versus 22Fr Sheath

Study Overview
=================
Brief Summary
-----------------
The rationale for this study is to assess whether there is a difference in HoLEP outcomes in smaller 22Fr instruments compared to our standard 28Fr sheaths.

Detailed Description
-----------------
This study will be a randomized controlled trial in which patients who meet inclusion criteria will be randomized to one of two groups, HoLEP performed with either 1) 22Fr sheath set or 2) 28Fr sheath set. After HoLEP, data will be analyzed using chi-square test for incontinence vs no incontinence between 22Fr and 28Fr groups at 1 week, 4 weeks and 12 weeks post operatively.

Official Title
-----------------
28Fr Versus 22Fr HoLEP, A Randomized Controlled Trial Indiana University School of Medicine, Department of Urology

Conditions
-----------------
Urinary Incontinence

Intervention / Treatment
-----------------
* Procedure: HoLEP Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:• Age >18 years old Undergoing HoLEP for benign prostatic enlargement Eligible for same day catheter removal Exclusion Criteria: Age < 18 years old Existing stress or urge urinary incontinence Planned overnight admission or overnight catheterization

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: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: We hypothesize there will be lower rates of immediate urinary incontinence, and urethral stricture formation in patients undergoing HoLEP with smaller 22Fr sheaths compared to 28 Fr.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: HoLEP surgery<br>HoLEP will be performed per standard clinical care with the instruments assigned at randomization - 22Fr or 28Fr. | Procedure: HoLEP Surgery<br>* HoLEP will be performed per standard clinical care with the instruments assigned at randomization - 22Fr or 28Fr.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing differences in HoLEP outcomes in smaller 22Fr instruments compared to our standard 28Fr sheaths. | Measuring rates of immediate urinary incontinence or complications post-operation HoLEP using the Michigan Incontinence System Index (M-ISI) survey. | M-ISI survey completed at 1,4,12 weeks |
1-Week Dispensing Evaluation of REVIVE™ Toric Soft Contact Lenses

Study Overview
=================
Brief Summary
-----------------
Experienced soft contact lens wearing subjects will be enrolled in this 1-week, post-market, bilateral, repeated measures, dispensing study. All subjects will be seen for a Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If subjects satisfy all eligibility criteria and none of the exclusion criteria, subjects will be fit and dispensed study lenses. If unsuccessful in the dispensed lenses, additional lenses may be trialed. Once vision and lens fit are determined to be acceptable, eligible subjects will wear study lenses in both eyes for at least 8 hours per day (with the exception of the follow-up visits where the lenses should be worn for a minimum of 2 hours), for approximately 1 week (7 days +/-3 days). Measurements will be taken at the insertion visit and at the 7-day follow-up visit.

Official Title
-----------------
1-Week Dispensing Evaluation of REVIVE™ Toric Soft Contact Lenses

Conditions
-----------------
Refractive Ametropia

Intervention / Treatment
-----------------
* Device: REVIVE Contact Lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be 18 years or older on the date the Informed Consent Form (ICF) is signed and have capacity to read, understand and provide written voluntary informed consent. Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings. Have no active ocular disease or allergic conjunctivitis. Not be using any topical ocular medications. Be willing and able to follow instructions. Have signed a statement of informed consent Exclusion Criteria: Participating in a conflicting study in the opinion of the Investigator. Considered by the Investigator to not be a suitable candidate for participation.

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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: REVIVE™ Toric Soft Contact Lenses<br> | Device: REVIVE Contact Lens<br>* REVIVE Contact Lens<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean logMAR Visual Acuity at 6m | Mean logMAR Visual Acuity at 6m | At one week follow up |