linjc16/ctgov huggingface dataset:
Quality of Life and Participation of the Adult With Spinal Muscular Atrophy in France

Study Overview
=================
Brief Summary
-----------------
Spinal muscular atrophy is a hereditary motorneuron disease caused by a mutation of the SMN1 gene, which is at the origin of a progressive limb and axial motor deficiency. It concerns 1200 individuals in France, including 700 adults in 2018. The main objective of this study is to assess the quality of life of SMA patients in France. The secondary objectives are, in one hand, to compare the quality of life of SMA patients to a population of neuromuscular diseases patients. And on the other hand to evaluate the determinants of participation and the impact of participation on quality of life in adult SMA patients.

Official Title
-----------------
Specificities of Quality of Life and Influence of Participation on the Quality of Life of the Adult With Spinal Muscular Atrophy in France: a Cross-sectional Study

Conditions
-----------------
Spinal Muscular Atrophy

Intervention / Treatment
-----------------
* Other: SMA adult patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with SMA type 1, 2, 3 or 4 ≥ 18 years old giving informed consent to participate to the study patients from the study of Dany et al Construction of a Quality of Life Questionnaire for slowly progressive neuromuscular disease (2015) Exclusion Criteria: patients who do not complete ≥ 80% of the questionnaire)-

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| SMA adult patients<br> | Other: SMA adult patients<br>* An online questionnaire aimed at collecting demographic and social data, and data concerning activity limitations, participation and quality of life of SMA patients from validated scales : QOLNMD, Rosenberg.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Quality of life of adult patients with spinal muscular atrophy in France, assessed using the QOLNMD score | At inclusion |
Genetic Assessment of the Patients With Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
Metabolic syndrome is a combination of medical disorders that increase the risk of developing cardiovascular disease and diabetes. The exact mechanisms of the complex pathways of metabolic syndrome are not yet completely known. The pathophysiology is extremely complex and has been only partially elucidated. Most patients are older, obese, sedentary, and have a degree of insulin resistance. Stress can also be a contributing factor. The most important factors are: weight, genetics, aging, sedentary lifestyle,excess caloric intake. In our study we will assess the role of some polymorphisms in the pathology of metabolic syndrome.

Detailed Description
-----------------
Eligibility criteria to the study: patients with metabolic syndrome with written consent

Official Title
-----------------
Genetic Assessment of the Patients With Metabolic Syndrome in Polish Population

Conditions
-----------------
Metabolic Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with metabolic syndrome according to IDF,AHA and NHLBI 2009 Exclusion Criteria: diabetes type 1 cancer not consent steroid therapy alcohol or drug abuse chronic inflammatory disease pregnancy or lactation severe hypothyroidism immunosuppressive treatment operation or severe injury during the last month

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 |
| --- | --- |
| control group<br>healthy volunteers | |
| Metabolic group<br>Patients with metabolic syndrome | |

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes, obesity, hypertension, dyslipidemia
My Hearing Experience - a Study About the Effect of Personality and Lifestyle on Everyday Hearing

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to investigate how personality, motivation & auditory lifestyle relate to hearing aid satisfaction & acceptance for first-time hearing aid users. As such, first-time hearing aid users will be followed via an app for a period of six months. They will answer baseline questionnaires about personality, lifestyle and hearing aid expectations before the first fit. After the hearing aid fitting, they will be prompted by the app to answer questionnaires about their hearing aid experience at weeks 2, 4, 8, 12, 16, 20 and 24.

Official Title
-----------------
My Hearing Experience - a Study About the Effect of Personality and Lifestyle on Everyday Hearing

Conditions
-----------------
Hearing Impairment, Hearing Loss

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-85 years of age Sensorineural hearing loss within the hearing aid's fitting range Fluency in local language First-time hearing aid user Experienced smartphone and app user Must sign the informed consent Exclusion Criteria: Severe cognitive impairment that would preclude the ability to perform the necessary tasks (as judged by the HCP) Inability for the TPs to travel to the clinic during the study period Complex hearing disorders such as Ménière's

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall hearing aid satisfaction | minimum: 1, maximum: 10 ; the higher value indicates a better outcome | 6 months | 
| IOI-HA | minimum: 7, maximum: 35; the higher value indicates a better outcome | 6 months | 
| hearing aid satisfaction (Hearing-Related Lifestyle scale) | minimum: 1, maximum: 5; the higher value indicates a better outcome | 6 months |
Noradrenergic Activity and Attention

Study Overview
=================
Brief Summary
-----------------
Older adults demonstrate increased distractibility by task-irrelevant information which contributes to general cognitive impairment. However, it is yet unclear how changes in noradrenergic activity during aging influences attentional control. In the current study, tonic noradrenergic activity will be increased or decreased to investigate its behavioral and neural effects on attentional control.

Official Title
-----------------
The Influence of Noradrenergic Activity on Attentional Control in Younger and Older Adults

Conditions
-----------------
Aging

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fluent in English Aged between 18-35 or 50-80 Have normal or corrected-to-normal vision and hearing, and normal color vision Have a mobile phone and email address Exclusion Criteria: Non-English speakers Currently practicing any relaxation, meditation, or breathing technique for more than an hour per week Have participated in studies measuring attentional capture in the past year Experiencing symptoms of dementia

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 |
| --- | --- |
| Young Adults<br>Young Adults aged 18-35 | |
| Older Adults<br>Older Adults aged 50-80 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initial eye-movements toward target and distractor shapes measured by an eye-tracker | The oculomotor suppression effect is a lower likelihood that salient display items will be the target of the initial eye movement in a visual search task compared to nonsalient display items. Using an eye-tracker, initial fixations toward the target, salient distractor, and nonsalient distractors will be compared as a measure of attentional control. | Calculated once at the end of the 1 day experiment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
attention, arousal
Observational Study to Investigate the Efficacy and Safety of Human Insulin or Insulin Analogue Treatments in Type 2 Diabetes Subjects

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Asia. The aim of this observational study is to investigate the percentage of patients reaching the treatment target on blood glucose control after treatment with either human insulin or insulin analogues in type 2 diabetes subjects inadequately controlled with two or more oral antidiabetic drugs in China. Further the safety profiles will be evaluated.

Official Title
-----------------
A 16-week Multicentre, Open Label, Non-interventional, Observational Study to Investigate the Status of Human Insulin or Insulin Analogue Treatments With Focusing on Efficacy and Safety in Type 2 Diabetes Subjects Inadequately Controlled With Two or More Oral Antidiabetic Drugs in China

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: human insulin
* Drug: insulin analogue


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: After the investigator has taken the decision to use human insulin or insulin analogues to treat the subject, any type 2 diabetic previously inadequately controlled with two or more OADs is eligible for the study The selection of the subjects will be at the discretion of the individual investigator Exclusion Criteria: Known or suspected allergy to trial product(s) or related products Subjects who are unlikely to comply with protocol requirements, e.g. uncooperative attitude, inability to return for the final visit Subjects who previously enrolled in this study Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods The receipt of any investigational product within 3 months prior to this trial
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br> | Drug: human insulin<br>* Any kind of human insulin administered at the discretion of the physician<br>|
| B<br> | Drug: insulin analogue<br>* Any kind of insulin analogue administered at the discretion of the physician<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients achieving HbA1c below 7.0% |  | at 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c change from baseline |  | at 16 weeks | 
| Incidence of major, minor and symptoms only hypoglycaemic episodes |  | at 16 weeks | 
| Comparison of scores of Insulin Treatment Appraisal Scale (ITAS) |  | at baseline and at 16 weeks |
Comparison of Diagnostic Accuracies of Various Endoscopic Examination Techniques

Study Overview
=================
Brief Summary
-----------------
Endoscopic diagnosis of lateral spreading tumours (LST) with submucosal invasion is important in guiding the treatment strategy. The use of advanced imaging is not standard clinical practice in China. A clinical trial is now under way comparing the accuracy of narrow band imaging (NBI), endoscopic ultrasonography (EUS) and magnifying chromoendoscopy (MCE) for the diagnosis of LST with submucosal invasion.

Detailed Description
-----------------
Endoscopic diagnosis of lateral spreading tumours (LST) with submucosal invasion is important in guiding the treatment strategy. The use of advanced imaging is not standard clinical practice in China. A clinical trial is now under way comparing the accuracy of narrow band imaging (NBI), endoscopic ultrasonography (EUS) and magnifying chromoendoscopy (MCE) for the diagnosis of LST with submucosal invasion.The final histologic diagnosis was used as the true diagnosis in the present study. By comparing the consistency of histologic diagnosis and preoperative evaluation,the diagnostic accuracies of various endoscopic examination techniques(narrow band imaging , endoscopic ultrasonography , and magnifying chromoendoscopy) was calculated respectively.

Official Title
-----------------
Comparison of Diagnostic Accuracies of Various Endoscopic Examination Techniques for Evaluating the Invasion Depth of Lateral Spreading Tumours (LST).

Conditions
-----------------
Colorectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - patients older than 18 years and Less than 65 years patients with endoscopic diagnosis of lateral spreading tumours signed informed consent Exclusion Criteria: - patients with serious heart, brain, lung, kidney complications patients with intestinal obstruction previous therapy for colorectal cancer women in gestational and lactational period taking anticoagulants or antiplatelet medications. based on the evaluations of physicians, the patient's condition is not suitable for the clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Diagnostic Accuracies | The final histologic diagnosis was used as the true diagnosis in the present study. By comparing the consistency of histologic diagnosis and preoperative evaluation,the diagnostic accuracies of various endoscopic examination techniques(narrow band imaging , endoscopic ultrasonography , and magnifying chromoendoscopy) was calculated respectively. | one week |
Covid-19 Rapid Diagnostic Tests on Blood Drop

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the diagnostic reliability of the Biosynex rapid blood test for Covid-19 infection.

Detailed Description
-----------------
The Covid-19 pandemic requires a reliable diagnosis of affected patients in order to manage them in an appropriate manner, in the appropriate departments. Furthermore, the diagnostic reference at the time of this study is based on reverse transcription by reaction in polymerase chain reaction (RT-PCR) on a nasopharyngeal swab taken. This method has may yield false negatives (up to 30% depending on the series) and its lead time is several hours. Alternatives are therefore being developed, in particular rapid blood tests. The rapid diagnostic test distributed by Biosynex has been evaluated by the National Reference Center for Respiratory Infections Viruses as very specific for the detection of IgG + IgM (93%). As part of the evaluation of this test, it was used in patients with severe Covid-19 disease, requiring hospitalization in critical care in order to be able to establish their reliability in a clinical context where many confounding factors may occur, such as lymphopenia or systemic inflammation. However, the early diagnosis of this patient population remains critical in order to be able to refer them to the appropriate services.

Official Title
-----------------
Evaluation of Covid-19 Rapid Diagnostic Tests on Blood Drop

Conditions
-----------------
Covid19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed COVID-19 diagnosis with at least one positive RT-PCR Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| One group of patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positivity of the rapid diagnostic test | Positivity of the rapid diagnostic test, assessed by the presence of either IgM or IgG | Immediate, up to 1 day. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Covid 19, Diagnostic, Biosynex, Blood drop
Pangenomic Study During Alcoholic Cirrhosis

Study Overview
=================
Brief Summary
-----------------
Hepatocellular carcinoma (HCC) is a frequent complication of cirrhosis. Occurrence of HCC could be linked with multiple functional region of genome. The determining of a genomic mapping of  single nucleotide polymorphisms  (SNPs) permit to perform some genetic link studies with pathologies without clear hereditary disposition. In this study, the investigators will identify predictives genetic polymorphism of HCC.

Official Title
-----------------
Genetical Predisposition in Hepatocellular Carcinoma : Pangenomic Link Study During Alcoholic Cirrhosis

Conditions
-----------------
Alcoholic Cirrhosis

Intervention / Treatment
-----------------
* Genetic: DNA extraction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 35 to 70 years old Compensated cirrhosis or not Caucasian origin of the parents Patient with cirrhosis (histological proof or obvious) Exclusion Criteria: HIV, HBV, HCV positive Known Homozygotia (C282Y+/+) Important hepatocytary iron overload for patient with resection HCC non histologically prooved

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 70 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 |
| --- | --- |
| alcoholic cirrhosis with viral infection<br>patient with alcoholic cirrhosis with viral infection (300 patients) | Genetic: DNA extraction<br>* DNA extraction of blood sample for DNAship analysis<br>|
| alcoholic cirrhosis without viral infection<br>patient with alcoholic cirrhosis without viral infection | Genetic: DNA extraction<br>* DNA extraction of blood sample for DNAship analysis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Existence of HCC and Pangenomic analysis of DNA polymorphism | Existence of HCC and determination of which genetic polymorphism are predisposing to HCC or preventing for HCC |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cirrhosis severity (compensated or not) | Analysis of the genetic polymorphism involved in the severity of cirrhosis |  |
Comparison of the Clinical Examination and the Joint Ultrasonography in Lupus Patients

Study Overview
=================
Brief Summary
-----------------
Arthritis is a current manifestation of systemic lupus erythematosus (SLE) and participates to the SLEDAI composite score calculation (0 to 105). Ultrasonography (US) is a validated and sensitive tool for joint assessment. Published studies showed US joint abnormalities in systemic lupus erythematosus patients with or without joint pain. Nevertheless, ultrasonography evaluations were not standardized and no study compared clinical and ultrasonography assessments. The objectives were 1) to describe ultrasonography joint abnormalities in systemic lupus erythematosus population, 2) to compare clinical and ultrasonography standardized joint assessments, 3) to estimate the reliability of clinical swollen joint count (C-SJC) and SLEDAI (C-SLEDAI) score versus ultrasonography-SJC and ultrasonography-SLEDAI.

Official Title
-----------------
Comparison of the Clinical Examination and the Joint Ultrasonography in the Evaluation of Disease Activity in Systemic Lupus Patients

Conditions
-----------------
Lupus Erythematosus, Systemic

Intervention / Treatment
-----------------
* Other: Ultrasonography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Systemic Lupus Erythematosus patients (with or without joint involvement). subjects will have to sign the inform consent before the beginning of the study Exclusion Criteria: Current pregnancy or no effective contraception

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasonography<br>B-mode and power Doppler Ultrasonography examination | Other: Ultrasonography<br>* B-mode and power Doppler ultrasonography examination.Ultrasonography assessments includes wrists, metacarpophalangeal, proximal interphalangeal, elbows, shoulders, knees, ankles, metatarsophalangeal and twenty six tendons (wrist extensors, finger flectors and tendons of the ankles).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasonography record (synovitis / tenosynovitis / effusion) |  | Day 0 (there is only one point measurement in the study) | 
| Clinical joint assessment (synovitis / tenosynovitis / effusion) |  | Day 0 | 
| Evaluate SELENA SLEDAI (C-SLEDAI) score |  | Day 0 | 
| Evaluate musculoskeletal BILAG score |  | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ultrasonography, Clinical assesment, joint abnormalities