linjc16/ctgov huggingface dataset:
Safety of NGOIS Compared to BSS Plus in Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
To evaluate the Safety of Next Generation Ophthalmic Irrigating Solution compared to BSS Plus for use during cataract surgery in Pediatric patients.

Official Title
-----------------
Safety of NGOIS Compared to BSS Plus in Pediatric Patients

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Drug: Next Generation Ophthalmic Irrigating Solution (NGOIS)
* Drug: BSS Plus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cataract present. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: As per age requirements. Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 1 Week
Maximum Age: 17 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NGOIS<br> | Drug: Next Generation Ophthalmic Irrigating Solution (NGOIS)<br>* Volume sufficient to irrigate adequately during cataract surgery<br>|
| Active Comparator: BSS Plus<br> | Drug: BSS Plus<br>* Volume sufficient to irrigate adequately during cataract surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Variables: Endothelial cell density, visual acuity, intraocular pressure, ocular signs and fundus assessment |  |  |
Inspection of the Colon Using a Retrograde Viewing Device for Detection of Colorectal Polyps

Study Overview
=================
Brief Summary
-----------------
During standard colonoscopy a substantial number of colorectal polyps may be missed. Previous studies have found a 12-28% of miss rate for all polyps, a 31% for hyperplastic polyps and 6-27% for adenomas. In this study it is tested whether a retro viewing endoscope can detect more colorectal polyps in comparisson to standard forward viewing endoscopy. Further, ppolyps detected, mean adenomas per Patient and withdrawal time are recorded.

Official Title
-----------------
Inspection of the Colon Using a Retrograde Viewing Device for Detection of Colorectal Polyps

Conditions
-----------------
Adenoma, Polyps

Intervention / Treatment
-----------------
* Diagnostic Test: Retroviewing endoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: screening colonoscopy 18 years of age Exclusion Criteria: inflammatory bowel disease inadequate bowel preparation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Retroviewing endoscopy (RVE)<br>Withdrawal in every colonic segment with SFV (standard forward view) followed by another withdrawal with the retroviewing endoscope. Allocation of patients to each arm (RVE or SFVE) is done by randomization using sealed envelopes. | Diagnostic Test: Retroviewing endoscopy<br>* The colon is inspected with a new retroviewing endoscope<br>|
| Active Comparator: standard forward viewing endoscopy (SFVE)<br>Withdrawal in every colonic segment with SFV followed by another withdrawal with SFV. Allocation of patients to each arm (RVE or SFVE) is done by randomization using sealed envelopes. | Diagnostic Test: Retroviewing endoscopy<br>* The colon is inspected with a new retroviewing endoscope<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma detection rate | calculation of the adenoma detection rate in each arm | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polyp detection rate | polyp detection rate in each arm | 8 months | 
| Mean number of adenomas per patient | Mean number of adenomas per patient in each arm | 8 months | 
| Withdrawal time | Withdrawal time in each arm | 8 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
retroviewing, endoscopy, adenoma detection, polyp detection
HES and NICOR Data Linkage for Cardiac Failure Population Analysis

Study Overview
=================
Brief Summary
-----------------
This study is a population-based, patient-level analysis of heart failure in England over a 5-year period using a dataset created by linking HES and NICOR databases. Our analyses will look into the re-occurrence of hospitalisation after the initial diagnosis of heart failure, the influence of population factors on risk of re-hospitalisation, and the resultant cost implications in an NHS environment.

Detailed Description
-----------------
Data from the National Heart Failure Audit (NICOR) and Hospital Episodes Statistics (NHS Digital) will be linked, by NHS Digital, using fields that are recorded in both databases (for example, NHS number). We will receive de-anonymised data that has been pseudo-anonymised, allowing for patient-level analyses but without identifying individual patients.

Official Title
-----------------
HES and NICOR Data Linkage for Cardiac Failure Population Analysis

Conditions
-----------------
Heart Failure, Registries, Patient Readmission

Intervention / Treatment
-----------------
* Other: Patients admitted to hospital


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients >17 years old individual patient data appears on both HES and NICOR databases 4-character primary diagnosis codes I50.0-I50.9 Exclusion Criteria: patient requests withdrawal from analyses

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 |
| --- | --- |
| Heart failure patients<br>All patients in NICOR's National Heart Failure Audit will be matched to those in NHS Digital's HES database who have a 4-character primary diagnosis of I50.0-I50.9. | Other: Patients admitted to hospital<br>* Data is captured in HES for all patient interactions with the NHS (each episode) in England. All patients admitted for heart failure have data captured in the National Heart Failure Audit.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmission | Any repeat hospitalisation for heart failure | 2012-2017 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hospital Episode Statistics, HES, National Institute for Cardiovascular Outcomes Research, NICOR, National Heart Failure Audit
Multimodality- Adapted Dose Modification in Head and Neck Cancer Radiation Therapy ￼

Study Overview
=================
Brief Summary
-----------------
This is a prospective trial evaluating dose escalation using an SBRT boost to poor- responding tumors by interim functional imaging (PET/CT and fMRI) to improve the local control of HNCSCC.

Official Title
-----------------
Multimodality- Adapted Dose Modification in Head and Neck Cancer Radiation Therapy Using Functional Imaging

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

Intervention / Treatment
-----------------
* Radiation: Dose escalation
* Radiation: Standard dose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: More than or equal to 18 years old. ECOG Performance Scale (0-2). Histological confirmation of SCC of the oral cavity, oropharynx, nasopharynx, hypopharynx or larynx. Clinical stage II-IVB (AJCC, 8th edition). Multidisciplinary decision of radical radiation or concurrent chemoradiotherapy (CCRT). Informed consent obtained, signed and dated before specific protocol procedures. Exclusion Criteria: Stage I/II glottic cancer. Patients who underwent surgery for the primary tumor location. Distant metastases. Inability to undergo PET-CT or MRI. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease- free for a minimum of 5 years. Prior radiotherapy to the region of the head and neck that would result in overlap of radiation fields. Any psychological, familial, sociological or geographical condition that hamper compliance with the study and/ or follow up schedule.

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: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose escalation<br> | Radiation: Dose escalation<br>* Dose escalation to poor responders to achieve dose equivalent more than 80 Gy using SBRT boost<br>|
| Active Comparator: Standard dose<br> | Radiation: Standard dose<br>* Standard dose to good responders to achieve dose equivalent of 70 Gy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Loco-regional control of HNSCC patients. |  | 2 years loco-regional control. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute radiation toxicity |  | During treatment and up to 6 months post treatment. | 
| Comparison between different parameters of PET/CT and fMRI in assessing response to treatment. |  | 2-4 weeks after start of treatment | 
| Overall survival |  | 2 years overall survival |
Machine Perfusion in High vs Low/Mid-volume Liver Transplant Centers: a Multicentre Survey

Study Overview
=================
Brief Summary
-----------------
Introduction: Machine perfusion (MP) was developed to expand the available donor pool and to improve liver transplantation outcomes. Despite optimal results in clinical trials, MP benefit outside of clinical experimentation in unknown. Low/mid volume centres (L/MVCs) may face logistical/economical difficulties that may in turn hamper optimal MP results. Methods: An Online 22-item survey on the use of machine perfusion for liver transplantation outside of clinical trials, was distributed to worldwide LT centres representatives. Variables of interest included MP logistics, MP technicalities, MP results, post-MP LT results. Responding centres were grouped into high volume centre (HVCs)(defined as >60 LTs per year in 2019) and L/MVCs. Results from HVCs vs L/MVCs were compared.

Official Title
-----------------
Machine-perfusion for Liver Transplantation in High Versus Low/Mid-volume Centres: an International Multicentre Survey

Conditions
-----------------
Organ Preservation Solution

Intervention / Treatment
-----------------
* Device: MACHINE PERFUSION


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: LT centres that use MP LT centres which perform LT before pandemic time (before 2019 included) LT centres which perform LT from cadaveric donors and living donors Exclusion Criteria: LT centres that not use MP LT centres that use MP but on clinical trials
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Low/mid-volume liver transplant centres<br> | Device: MACHINE PERFUSION<br>* Different outcomes of MP use in low/mid-volume and high-volume LT centres<br>|
| High-volume liver transplant centres<br> | Device: MACHINE PERFUSION<br>* Different outcomes of MP use in low/mid-volume and high-volume LT centres<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver transplant(LT) centres different use of graft after utilization of machine perfusion (MP) | High Volume Centers and Low/Mid Volume centers differ in their rates of graft utilization after Machine perfusion | 12/2021 - 03/2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver Transplant outcomes after Machine Perfusion | Reported patient survival rates for Liver Transplant after Machine Perfusion | 12/2021 - 03/2022 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
machine perfusion, liver transplant, low/mid volume transplant center
Impact of Sexual Violence on the Incidence of Voluntary Termination of Pregnancy in La Réunion

Study Overview
=================
Brief Summary
-----------------
According to the figures for the last three years collected from the Indian Ocean Regional Health Observatory, it appears to be about twice as many voluntary terminations of pregnancy on the island of Reunion compared with France metropolitain region. Furthermore, the overseas section in 2002, which looked at violence against women of all types in three different spheres of life (the marital sphere, the workplace and public spaces), tends to show a much higher incidence of sexual violence than in metropolitain France. This trend seems to be confirmed by the overseas section of the VIRAGE survey started in 2018 on the island. Furthermore, data found in a qualitative study conducted in Ile de France in 2013 seems to demonstrate a more frequent use of abortion among patients who are victims of sexual violence. Thus, thiçs study will consist in evaluating the impact of sexual violence on the incidence of voluntary termination of pregnancy in Reunion Island.

Official Title
-----------------
Impact Des Violences Sexuelles Sur l'Incidence Des Interruptions Volontaires de Grossesses à La Réunion/ Impact of Sexual Violence on the Incidence of Voluntary Termination of Pregnancy in La Réunion

Conditions
-----------------
Sexual Violence, Abortion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Adult patient coming for an abortion request at the CHU SUD and NORD, at the GHER and at the CEPS for the CHOR (Reunion Island) Exclusion Criteria: Patient coming to the above-mentioned centres for a post-abortion consultation. <18 years Patient who does not speak French. Illiterate patient. Patient who has already completed the questionnaire. Patient refusing to participate in the study.

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

Sexes Eligible for Study
-----------------
Female

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of women victims of sexual abuse coming for a voluntary termination of pregnancy | Number of patients coming for a voluntary termination of pregnancy sexually abused | Day 1 |
Immunomodulation Effect of Regional Citrate Anticoagulation in Acute Kidney Injury Requiring Continuous Renal Replacement Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the effect of anticoagulation in immune response with Acute Kidney Injury (AKI) undergoing Continuous Renal Replacement Therapy (CRRT).

Conditions
-----------------
Acute Kidney Injury

Intervention / Treatment
-----------------
* Procedure: Continuous renal replacement therapy with regional citrate anticoagulation
* Procedure: Continuous renal replacement therapy with no anticoagulation or heparin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Systemic inflammatory response syndrome; SIRS > or = 2 meets definition Patients with acute kidney injury in the intensive care ward. Requiring continuous renal replacement therapy. Exclusion Criteria: Pregnancy Cirrhosis End stage renal disease HIV infection Serum creatinine in male > 2 mg/dl and female > 1.5 mg/dl Bleeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AKI requring CRRT and use regional citrate anticoagulation<br>CRRT use regional citrate anticoagulation | Procedure: Continuous renal replacement therapy with regional citrate anticoagulation<br>* CRRT with anticoagulant : regional citrate anticoagulation Filter : AQUAMAX™ (Edwards Lifesciences)<br>* Other names: Continuous veno-venous hemofiltration;|
| Experimental: AKI requring CRRT and not use regional citrate anticoagulation<br>CRRT not use regional citrate anticoagulation | Procedure: Continuous renal replacement therapy with no anticoagulation or heparin<br>* CRRT with any anticoagulant : no anticoagulation or heparin Filter : AQUAMAX™ (Edwards Lifesciences)<br>* Other names: Continuous veno-venous hemofiltration;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functions of inflammatory cells | CD11b expression on PMN and HLA-DR expression on monocyte | 24 hours | 
| Regulation of inflammatory reactions and and opsonization in microorganisms | C3a and C5a | 24 hours | 
| Activity of acute phase protein during acute inflammation | PAI-1 | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival rate |  | 28 days | 
| length of ICU stay |  | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Kidney Injury Requiring Continuous Renal Replacement Therapy
A Study of the Potential Risk Factors Linked to the Development of Severe Forms of Endometriosis

Study Overview
=================
Brief Summary
-----------------
This study will aim to identify genetic, medical, dietary and environmental factors associated with the development of endometrioma and/or deep infiltrating endometriosis in order to move towards early diagnosis and implementation of potential preventative measures.

Official Title
-----------------
A Multi-centre, Multinational, Cross-sectional, Incident Case-control Study on Factors Associated With the Development of Endometrioma and Deep Infiltrating Endometriosis

Conditions
-----------------
Endometriosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject is a female aged between 18 and 41 years The subject has undergone a laparoscopy or laparotomy for a benign gynecological indication excluding pregnancy, in the last 3 months The subject's surgery showed either no visible endometriosis lesions or histologically confirmed endometriosis lesions: superficial endometriosis, endometrioma or deep infiltrating endometriosis The subject has given a written informed consent prior to any study-related procedures Exclusion Criteria: The subject is pregnant The subject's surgery results showed evidence of malignancy The subject has a mental condition rendering her unable to understand the nature, scope and possible consequences of the study, and/or with evidence of an uncooperative attitude

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 41 Years

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No endometriosis<br> | |
| Superficial endometriosis<br> | |
| Endometrioma<br> | |
| Deep infiltrating endometriosis<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors associated with endometrioma and/or deep infiltrating endometriosis using retrospective data collection and patient questionnaire. |  | Enrolment visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors associated with superficial endometriosis using retrospective data collection and patient questionnaire. |  | Enrolment visit | 
| Factors associated with endometrioma and/or deep infiltrating endometriosis according to subject ethnicity using retrospective data collection and patient questionnaire. |  | Enrolment visit | 
| Subject's characteristics by endometriosis status using retrospective data collection and patient questionnaire. |  | Enrolment visit |
The Relationship Between Muscle Morphology and Muscle Strength

Study Overview
=================
Brief Summary
-----------------
The evaluation of skeletal muscle strength in severly ill or cognitive impaired patients is an unresolved problem especially during the rehabilitation process. The aim of this study is to correlate morphological parameters assessed with muscle ultrasound and isometric muscle strength to establish an objective progression parameter for rehabilitation therapies.

Official Title
-----------------
The Relationship Between Muscle Morphology and Muscle Strength

Conditions
-----------------
Skeletal Muscle Ultrasound, Isometric Muscle Strength

Intervention / Treatment
-----------------
* Device: Siemens Acuson Antares ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: group 1: patients between 18 and 35 years group 2: patients between 60 and 80 years Exclusion Criteria: neuromuscular diseases hip or knee prosthesis in the investigated leg any trauma of the hip, knee or ankle of the investigated leg during the last 12 months cognitive impairments pregnancy diabetes mellitus Type II acute or chronic pain in the investigated leg chronic maligne or non - maligne diseases (of the heart, lung or kidney)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Group 1: young healthy patients<br> | Device: Siemens Acuson Antares ultrasound<br>* skeletal muscle ultrasound of the musculus quadriceps, on two different days, two observers<br>|
| Group 2: old healthy patients<br> | Device: Siemens Acuson Antares ultrasound<br>* skeletal muscle ultrasound of the musculus quadriceps, on two different days, two observers<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |