linjc16/ctgov huggingface dataset:
Frailty, Cognitive Function and Health-related Quality of Life in Older Adults With Advanced Chronic Kidney Disease.

Study Overview
=================
Brief Summary
-----------------
This observational study explores the impact of cognitive impairment and frailty in older adults with advanced chronic kidney disease ]. The main question[s] it aims to answer are: What determines the time to initiate dialysis? Cognitive impairment or frailty? What does predict the time to death? Presence of frailty or cognitive impairment? What does correlate strongly with time-low health-related quality of life? frailty or cognitive impairment?

Official Title
-----------------
Frailty, Cognitive Function and Health-related Quality of Life in Older Adults With Advanced Chronic Kidney Disease: Mortality and Dialysis Initiation, a Prospective Cohort Study.

Conditions
-----------------
Frailty, CKD Stage 4, CKD Stage 5, Cognitive Impairment

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients age 65 years or older. CKD stage 4 and 5 who were identified by two consecutive measurements of estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 separated by more than 3 months. Exclusion Criteria: Patients younger than 65 years old. Chronic kidney disease stages 1,2, and 3. Dialysis dependence History of kidney transplantation. Initial visit with the health care provider. Recent acute kidney injury. Patients who had been hospitalized for more than 2 months before the visit (because long hospitalization might affect the degree of frailty) Patients with myocardial infarction and cerebrovascular accident 3 months before the assessment Patients who are blind or with limb amputation. Patients who refuse to participate.

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- | --- |
| Time to death | The time from the assessment moment to death of an older adult with advanced CKD ( CKD stage 4 and 5). | 36 months | 
| Time to initiate dialysis. | The time from the assessment moment to start dialysis of an older adult with advanced CKD ( | 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CKD, FRAILTY, HRQOL
Assessment of Immune Response in Multiple Sclerosis Patients With COVID-19/Vaccination Treated With Ofatumumab and Other Disease Modifying Therapies

Study Overview
=================
Brief Summary
-----------------
Vaccine responses in patients treated with anti-CD20 antibodies (ocrelizumab and ofatumumab) or S1P receptor modulators (fingolimod and siponimod) were evaluated before and after third SARS-CoV-2 vaccination as part of an ongoing longitudinal study. Total spike protein and spike receptor binding domain (RBD)-specific immunoglobulin G (IgG) responses were measured by Luminex bead-based assay. Spike-specific CD4+ and CD8+ T cell responses were measured by activation-induced marker expression.

Official Title
-----------------
Assessment of Immune Response in Multiple Sclerosis Patients With COVID-19/Vaccination Treated With Ofatumumab and Other Disease Modifying Therapies

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria All Participants: Aged 18-75 years old MS Patients Diagnosed with MS based on 2017 McDonald criteria Exclusion Criteria All Participants: Participants with a known history of COVID-19 Healthy Adults Immunocompromised or on immunosuppressive therapy MS Patients None specified

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| HC<br>Healthy control | |
| OFA<br>Received ofatumumab | |
| OCR<br>Received ocrelizumab | |
| S1P<br>Received sphingosine-1-phosphate receptor modulator | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants achieving humoral response (i.e. immune response) to an FDA-authorized COVID 19 vaccine in ofatumumab treated participants |  | varied up to 6 months | 
| Percentage of participants achieving T-cell response (i.e. immune response) to an FDA-authorized COVID 19 vaccine in ofatumumab treated participants |  | varied up to 6 months |
Vincere Biobank Research Protocol

Study Overview
=================
Brief Summary
-----------------
The Vincere Biobank aims to make quality biospecimens and associated clinical data available for research studies related to advancing medicine and improving care for patients, including cancer screening, treatment, and care.

Official Title
-----------------
Vincere Biobank Research Protocol

Conditions
-----------------
Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older; any gender Able to donate a blood, urine, tissue, and/or other biospecimen sample Able to provide informed consent to participate in the study Exclusion Criteria: Minors, under the age of 18 years Individuals who lack the capacity to give informed consent

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 |
| --- | --- |
| Normal<br>Participants and donor samples without disease (ex: non-cancer) | |
| Disease state or condition<br>Participants and donor samples with known disease or condition (ex: cancer) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biobank | Collect quality biospecimens with associated clinical data for research studies related to improving medicine and care to the patient, including cancer screening, treatment, and care. | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer, Biobank, Biorepository
Hemorrhagic Complications of Transvaginal Oocyte's Retrieval: an Update.

Study Overview
=================
Brief Summary
-----------------
The goal of this retrospective analysis is to focus on peritoneal bleeding after oocyte retrieval and to further investigate factors related to this specific complication and if hemorrhagic complication rate modifications can be observed.

Detailed Description
-----------------
The main aim is to update our knowledge on oocyte retrieval complication, focusing specifically on hemorrhagic / hemoperitoneum rate. All retrievals will be retrieved in IVF/ICSI cycles and Fertility Preservation both in oncological patients and in patients requesting oocyte storage for deferring motherhood. Data collection goes from January 2017 to December 2022.

Official Title
-----------------
Hemorrhagic Complications of Transvaginal Oocyte's Retrieval: an Update.

Conditions
-----------------
ART, Infertility

Intervention / Treatment
-----------------
* Procedure: Oocyte retrieval


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients that underwent a procedure of oocyte transvaginal retrieval for IVF/ intracytoplasmatic sperm injection (ICSI) cycles and fertility preservation Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Oocyte retrieval|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoperitoneum after oocyte transvaginal retrieval | number of patients with onset of hemoperitoneum | Oocyte retrievals in the period January 2017- December 2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operator of the procedure | assessment of operator experience | 6 years | 
| Hemoglobin level before and after procedure | evaluation of hemoglobin level before and the day after procedure | 6 years | 
| Time of symptoms onset | evaluation of first symptoms onset | 6 years | 
| Loss of blood during procedure | average blood loss | 6 years | 
| Incidence compared to past case history | comparison with previous statistic | 6 years | 
| Need for hospitalization | patients requiring hospitalisation | 6 years |
Faecal Microbiota Analysis in Neurotypical and Autism Syndrome Disorder Siblings

Study Overview
=================
Brief Summary
-----------------
This study aims to accurately characterise the gut microbiota composition of faeces of children with ASD and compare it with the gut microbiota composition of their neurotypical siblings. In addition it aims to also characterise the metagenome and metabolome of the faeces of both ASD and neurotypical siblings.

Official Title
-----------------
Faecal Microbiota Analysis in Neurotypical and Autism Syndrome Disorder Siblings: FAMILY

Conditions
-----------------
Autism Spectrum Disorder, Autism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children of both sexes who are diagnosed with ASD and under the care of ESNEFT who have a neurotypical sibling (either full or half sibling), who share their living environment. This is due to the study requiring stool samples that are from siblings, to control for genes and environment where possible. Aged 3 years to 10 years old (at time of consent) Parent/guardian able to consent to participate Parent/guardian able to complete required surveys (or with accommodated adjustments) Exclusion Criteria: Use of antibiotics in the previous 4 weeks Not under the care of ESNEFT Children <3 years old and >10 years old Children that don't have half or full siblings Parent/guardian unable to provide informed consent or complete surveys, despite reasonable adjustments being implemented

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 10 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 |
| --- | --- |
| Children with Autism<br> | |
| Neurotypical siblings<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut microbiota | Gut microbiota composition of faeces of children with ASD | 0 weeks | 
| Gut microbiota | Gut microbiota composition of faeces of children with ASD | 6 weeks |
A Study Using Human Papillomavirus (HPV) DNA Testing to Detect HPV-Related Oropharyngeal Cancer (OPC)

Study Overview
=================
Brief Summary
-----------------
The researchers think that a blood test (NavDx®) may be able to identify cancer early by looking for circulating DNA from Human Papillomavirus/HPV. Circulating DNA are small pieces of genes that are released into the bloodstream. The purpose of this study is to find out whether using this blood test to test for HPV DNA will help detect HPV-related Oropharyngeal Cancer/OPC.

Official Title
-----------------
A Study of Using Plasma Circulating Cell Free Human Papillomavirus Deoxyribonucleic Acid to Screen (cf HPV DNA) for HPV-Related Oropharyngeal Cancer

Conditions
-----------------
Oropharyngeal Cancer, HPV-Related Carcinoma, HPV Positive Oropharyngeal Squamous Cell Carcinoma

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 45 and older Self-reported history of four or more lifetime sexual partners Self-reported history of one or more lifetime oral sexual partner No previous history of diagnosed HPV-related head and neck cancer Exclusion Criteria: History of diagnosed HPV-related OPC Less than three sexual partners in lifetime No history of oral sex performed Younger than age 45

Ages Eligible for Study
-----------------
Minimum Age: 45 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 |
| --- | --- |
| No previous history of diagnosed HPV-related head and neck cancer<br>Participants have no previous history of diagnosed HPV-related head and neck cancer | Diagnostic Test: NavDx<br>* Evaluation of HPV presence via NavDx (v1) at two (or three) timepoints o If one of the two blood samples is positive, the subject will have a third NavDx (v1) test approximately 1 month after the second timepoint. If the test is positive, the subject will move to surveillance phase.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants found to have HPV-related OPC | : The primary objective is to determine the feasibility of screening by estimating the yield (proportion of subjects found to have HPV-related OPC out of all subjects screened). | Up to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cf HPV DNA, HPV-Related Oropharyngeal Cancer, Human Papillomavirus, Oropharyngeal Cancer, HPV-Related Carcinoma, HPV Positive Oropharyngeal Squamous Cell Carcinoma, Cell Free Human Papillomavirus Deoxyribonucleic Acid, 22-234, Memorial Sloan Kettering Cancer Center
Automatic Abdominal Aortic Aneurysm Diameter Measurement

Study Overview
=================
Brief Summary
-----------------
Managing abdominal aortic aneurysms currently relies on diameter assessment with ultrasound. Diameter reproducibility with two-dimensional ultrasound is challenging, and requires experienced operators. A novel automatic three-dimensional ultrasound system has the potential to facilitate more precise diameter measurements than two-dimensional ultrasound. This study aimed to assess the variance of abdominal aortic aneurysm diameter measurements among ultrasound novices and experts by comparing two-dimensional ultrasound with the three-dimensional ultrasound system in a clinical setting. Ten patients under abdominal aortic aneurysm surveillance were examined by 29 ultrasound-operators: 13 experts and 16 novices. The experts were sonographers and physicians highly experienced in abdominal aortic aneurysm ultrasound, and the novices were medical students and junior residents with sparse ultrasound experience.

Official Title
-----------------
Automated Three-dimensional Ultrasound Bridges the Gap Between Novices and Experts in Diameter Assessment of Abdominal Aortic Aneurysms

Conditions
-----------------
AAA - Abdominal Aortic Aneurysm

Intervention / Treatment
-----------------
* Device: Philips EPIQ-7, Philips Healthcare, Bothell, WA, USA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Patients with an abdominal aortic aneurysm > 3 cm.
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<br>All ten patients had their abdominal aortic aneurysm measured by experts and novices using both two-dimensional and three-dimensional ultrasound | Device: Philips EPIQ-7, Philips Healthcare, Bothell, WA, USA<br>* All patients had their abdominal aortic aneurysm maximum anterior-posterior diameter estimated with two-dimensional ultrasound using a 5 MHz curved array transducer (Philips® C5-1 transducer, Philips Healthcare, Bothell, WA, USA). After the acquisition, a three-dimensional ultrasound acquisition was performed with a 3D-matrix transducer (Philips® X6-1 transducers, Philips Healthcare, Bothell, WA, USA).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal aortic aneurysm measurement variance between novices and experts | The primary outcome was to test the variance of abdominal aortic aneurysm diameter measurements by comparing expert and novice ultrasound operators using conventional 2D-ultrasound and 3D-software assisted ultrasound. | One week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ultrasound, Three dimensional ultrasound, Abdominal aortic aneurysm, Sonography, 3D ultrasound
Molecularly Aided Stratification for Tumor Eradication Research

Study Overview
=================
Brief Summary
-----------------
NCT/DKFZ/DKTK MASTER is a prospective, continuously recruiting, multicenter observational study for biology-guided stratification of adults with rare cancers, including rare subtypes of common entities, using comprehensive molecular profiling, and clinical decision-making in a multidisciplinary molecular tumor board.

Official Title
-----------------
NCT MASTER Plattform Molecularly Aided Stratification for Tumor Eradication Research

Conditions
-----------------
Rare Cancers, Multiomics

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rare cancer (Incidence <6/100,000 persons/year) or Rare subtype of a more common entity (case-by-case decision; example: pancreatic ductal adenocarcinoma without KRAS mutation) Metastatic and/or locally advanced cancer with no curative therapy option and indication for systemic therapy Exclusion Criteria: Severe neurological or psychiatric disorder interfering with the ability to give oral and written informed consent

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 |
| --- | --- | --- |
| progression free survival | Time period of progression survival from date of multiomics analysis | 5 years | 
| overall survival | time period of survival from date of diagnosis | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response to antitumor treatment | response according to RECIST v.1.1 criteria to antitumor treatment applied after multiomics analysis | 5 months |
Management of Women With Superficial Dyspareunia

Study Overview
=================
Brief Summary
-----------------
Superficial dyspareunia are persistent or recurrent pains during an attempt at sexual intercourse or during effective penetration. They affect between 3 to 18% of women and are a source of physical and psychological suffering. Some health professionals (gynecologists, general practitioners, midwives) are confronted daily with these complaints. The approach of sexuality remains a complex subject even within the medical field. As a result, communication between women and health professionals can be difficult, leading to delayed diagnosis or inadequate management.

Detailed Description
-----------------
The main objective is to describe the management of superficial dyspareunia by health professionals.

Official Title
-----------------
Management of Women With Superficial Dyspareunia

Conditions
-----------------
Superficial Dyspareunia

Intervention / Treatment
-----------------
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 or over Superficial dyspareunia, i.e.: Having already had several painful vaginal penetrative sex Having pain at the intromission (at the beginning of the vagina and at the level of the vulva) and/or at the beginning of penetration (by a penis, fingers, sextoys) Having persistent and/or recurrent pain (appearing in a manner regular) Agreeing to participate in the study Exclusion Criteria: Minors Protected by law (guardianship, curatorship, safeguarding of justice) Refusing to participate in the study

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women with superficial dyspareunia<br>Adult women, having sexual activity with or without vaginal penetration, suffering from superficial dyspareunia, whether or not managed by health professionals. | Other: Data collection<br>* data collection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| medical history | Question to the woman about possible pain during sexual intercourses by an health professional (yes or no) | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
superficial dyspareunia, management
Effect of Ocrelizumab on Choroid Plexus Changes in Patients With PPMS

Study Overview
=================
Brief Summary
-----------------
The goal of this non-interventional, observational study is to learn if cortical plexus enhancement in patients with primary progressive multiple sclerosis occurs in response to the autoimmune inflammatory process.

Detailed Description
-----------------
To study the effect of ocrelizumab on choroid plexus changes in patients with primary-progressive multiple sclerosis participating in the ORATORIO: a post-hoc analysis of a double-blind, randomized, phase 3, placebo-controlled study

Official Title
-----------------
Effect of Ocrelizumab on Choroid Plexus Changes in Patients With Primary-progressive Multiple Sclerosis Participating in the ORATORIO: a Post-hoc Analysis of a Double-blind, Randomized, Phase 3, Placebo-controlled Study

Conditions
-----------------
Primary Progressive Multiple Sclerosis

Intervention / Treatment
-----------------
* Other: Ocrelizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient participating in the ORATORIO study MRI scans available at baseline Presence of T2-weighted image (WI) (FLAIR, T2/PD), and 3D T1-WI at baseline Exclusion Criteria: - None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Ocrelizumab|Non-interventional|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T2 lesion volume | T2 lesion volume as measured using MRI. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in choroid plexus | Changes in choroid plexus as measured using MRI. | 5 years |