linjc16/ctgov huggingface dataset:
Spanish Version of the KBILD Questionnaire

Study Overview
=================
Brief Summary
-----------------
The purpose of the present study is to advance in the knowledge of quality of life in patients with ILD by translating a ILD quality of life questionnaire. There are no specific tools validated in Spanish to evaluate the quality of life in patients with ILD, although these measures are useful for an comprensive evaluation of these patients. Patients with ILD have a significant impact on their health. If we improve our Knowledge of the different domains affected by the disease, and not only in the pathophysiological ones, we will be able to develop tools to improve their management.

Official Title
-----------------
Translation Into Spanish of an Interstitial Lung Disease Quality of Life Questionnaire (KBILD)

Conditions
-----------------
Pulmonary Fibrosis

Intervention / Treatment
-----------------
* Other: Quality of life questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Subjects older than 18 years. Diagnosis of ILD, established according to the consensus documents of the ATS and ERS [1,2]. Acceptance of the patient to participate in the study by signing the informed consent after having discussed with the researchers the objectives, risks and potential benefits. Exclusion criteria Another chronic respiratory disease other than EPID. Psychiatric disorder or limitation of collaboration (including language, socio-cultural problem, etc.).

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

| Intervention/Treatment |
| --- |
|Other: Quality of life questionnaire|Measurement of quality of life|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of a specific quality of life questionnaire for patients with ILD |  | 6 months |
Volume 3D_US Kidney

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure the volume of the kidney and tumors using 3D-US acquisition and to correlate these measurements to contrast-enhanced CT or MRI.

Detailed Description
-----------------
Additional objectives are comparison between true volume measurements and volume estimation using measurements of the three perpendicular diameters, comparison of inter and intra variability of 3D US measurements with inter and intra variability of 3D CT or MRI measurements, calculation of 3D and 2D volume measurements during contrast-enhanced US examination when the injection is performed for clinical routine purposes such as vascular and extension staging, during interventional procedures such as US guided biopsy targeting the non-necrotic tumour parenchyma. Concordance between 2D and 3D US acquisitions will be compared to CT and MRI measurements. Comparison of volume measurements between non-contrast and contrast-enhanced methods (US, CT and MRI) will be performed. The results will be compared to renal function before and after tumour treatment.

Official Title
-----------------
Measurement of Kidney Volume and Renal Tumor Volume Using 3D-Ultrasound Imaging

Conditions
-----------------
Renal Tumor, Chronic Kidney Diseases

Intervention / Treatment
-----------------
* Other: Ultrasound Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient (age 18) Absence of participant's opposition No contra-indication to contrast-enhanced CT AND MRI (a single contrast-enhanced imaging modality is sufficient) Affiliated to Social Security Exclusion Criteria: - Contra-indication to both contrast-enhanced CT AND MRI

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 |
| --- | --- |
| VolUS3D patients<br>Patients with renal tumour | Other: Ultrasound Imaging<br>* 3D volume calculation using on-line and off-line softwares<br>* Other names: 3D Ultrasound transducer and fusion imaging;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3D-US volume measurements | Kidney and renal tumor | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2D-US volume measurements | Kidney and renal tumor | 1 month | 
| Inter and intra variability measurements | Kidney and renal tumor | 1 month | 
| 2D and 3D US volume measurements during Contrast-enhanced US (if performed for patient management) | Kidney and renal tumor | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
3D Ultrasound volume measurements, Renal volume, Tumour Volume
Investigate Bladder and Prostate During Emptying With Intermittent Catheter

Study Overview
=================
Brief Summary
-----------------
Explorative study investigating the urinary bladder and prostate during intermittent catheterization in healthy male adults by use of MR-scanning.

Detailed Description
-----------------
12 healthy male adults will be enrolled in the investigation. The study includes one study visit where MR-scans of the bladder and prostate will be performed during normal voiding as baseline measurement followed by measurements during emptying of the bladder with an intermittent catheter (SpeediCath CH12 standard male intermittent catheter).

Official Title
-----------------
Explorative Study Investigating the Urinary Bladder and Prostate During Intermittent Catheterization in Healthy Male Adults by Use of MR-scanning.

Conditions
-----------------
Urinary Function

Intervention / Treatment
-----------------
* Device: Coloplast SpeediCath CH12 standard male intermittent catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male Has given written informed consent Be at least 18 years of age and have full legal capacity Exclusion Criteria: Participate in any other clinical investigation Has symptoms of UTI (Investigator's judgement) Has known abnormalities and/or diseases in the bladder and/ or the lower urinary tract Has had previous disease or surgery in lower urinary tract Has any MR-scanning contraindication - according to MR check list

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

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Explore the behavior of the urinary bladder and prostate during emptying the bladder with an intermittent catheter. By use of 3D scanning techniques and dynamic MRI, the objective is to investigate behavior of bladder emptying using an intermittent catheter compared to the voluntary bladder emptying.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intermittent catheter<br>Coloplast SpeediCath CH12 male intermittent catheter | Device: Coloplast SpeediCath CH12 standard male intermittent catheter<br>* Drainage of the bladder through the urethra when using the SpeediCath standard male intermittent catheter.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bladder morphology | Evaluate bladder morphology and behavior during emptying of the bladder by performance of 3D and dynamic MRI | Within 1 year after termination | 
| Bladder behavior | Evaluate bladder behavior when emptying the bladder with an intermittent catheter evaluated by performance of 3D and dynamic MRI | Within 1 year after termination |
A Study to Evaluate the Safety of Escalating Doses of Ocrelizumab in Subjects With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
This is a randomized, placebo-controlled, multicenter, blinded Phase I/II, investigator and subject-blinded study of the safety of escalating doses of ocrelizumab in combination with MTX in subjects with moderate to severe RA

Official Title
-----------------
A Randomized, Placebo-Controlled, Multicenter, Blinded Phase I/II Study of the Safety of Escalating Doses of Ocrelizumab (PRO70769) in Subjects With Moderate to Severe Rheumatoid Arthritis Receiving Stable Doses of Concomitant Methotrexate

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: ocrelizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability and willingness to provide written informed consent and to comply with the requirements of the protocol Diagnosis of RA for at least 6 months according to the revised 1987 ACR criteria for the classification of RA Positive serum RF Current treatment for RA on an outpatient basis Contact your local site that is listed for more inclusion criteria Exclusion Criteria: Bone or joint surgery (including joint fusion) within 8 weeks prior to screening or joint surgery planned within 24 weeks after randomization Rheumatic autoimmune disease other than RA or significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis, or Felty�s syndrome) Functional Class IV as defined by the ACR classification of functional status in RA History of or current inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) or other systemic rheumatic disorders (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, overlap syndrome) Contact your local site that is listed for more exclusion criteria

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?
-----------------

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ocrelizumab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of ocrelizumab in subjects with moderate to severe RA |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of ocrelizumab |  |  | 
| Pharmacodynamics of ocrelizumab |  |  | 
| Percentage of subjects with clinical responses according to American College of Rheumatology (ACR) criteria |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Moderate to severe rheumatoid arthritis
The Effect of Alpha-lactalbumin on Microbiota Composition

Study Overview
=================
Brief Summary
-----------------
To evaluate the effects on microbiota composition after the administration of an oral supplementation based on Alpha-lactalbumin in subjects with dysbiosis.

Official Title
-----------------
Evaluation of Prebiotic Effects of Alpha-lactalbumin on Microbiota Composition

Conditions
-----------------
Alpha-lactalbumin, Microbiota, Dysbiosis

Intervention / Treatment
-----------------
* Dietary Supplement: Alpha-lactalbumin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: condition of dysbiosis Exclusion Criteria: antibiotic treatment within 1 month probiotic or prebiotic treatments concomitant inflammatory intestinal diseases pregnancy neoplastic diseases allergy to milk protein (Alpha-lactalbumin) substance abuse

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alpha-lactalbumin<br> | Dietary Supplement: Alpha-lactalbumin<br>* Oral assumption of two tabs/day containing Alpha-lactalbumin for 30 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of microbiota composition | Determination of bacterial biodiversity by metagenomics approach | Change from baseline microbiota composition to 30 days of treatment |
Metabolic Syndrome in Patients With First-episode Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The metabolic syndrome (MetS) is highly prevalent in patients with schizophrenia and is a major risk factor of type-2 diabetes, cardiovascular disease and early death. Genetic factors, antipsychotic medication, sleeping disturbances and unhealthy lifestyle are possible causes of developing metabolic syndrome. Several studies have investigated the metabolic side-effects of antipsychotic medication. However it is still unanswered how unhealthy lifestyle, comprising physical inactivity, smoking, unhealthy dieting, and sleeping disturbances adds to the metabolic risk of patients with schizophrenia. The aim of this study is to investigate the prevalence and development of MetS in first-episode patients with schizophrenia and 1 year after onset of treatment. The study's main hypothesis is that physical inactivity, regardless of medication, is an independent risk factor for metabolic syndrome in patients with schizophrenia. In comparison inpatients with major depression and healthy controls, both matched on gender, age and level of education will be included in the study. It is anticipated that the study's results will provide new knowledge about the risk of developing metabolic syndrome in first-episode schizophrenia and how different risk factors contribute to this.

Official Title
-----------------
The Metabolic Syndrome in Patients With First-episode Schizophrenia - Prognosis and Prediction.

Conditions
-----------------
Metabolic Syndrome X, Schizophrenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with ICD-10 diagnosed schizophrenia Exclusion Criteria: Antipsychotic medication > 6 weeks before inclusion Physical disability Pregnancy IQ< 55

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| Schizophrenia<br>Patients with first-episode schizophrenia age 18-45 years | |
| Depression<br>First-time hospitalized patients with depression age 18-45 years | |
| healthy controls<br>Healthy controls matched on age and gender (18-45 years) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| metabolic syndrome |  | 1 year |
Respiratory Weaning Following Cardiac Surgery.

Study Overview
=================
Brief Summary
-----------------
Respiratory weaning failure worsens prognostic of patients following on-pump cardiac surgery. There are increasing evidences that pulmonary, diaphragmatic or cardiologic echographies are useful in order to improve this critical medical status. Based both on a previous study conducted in the critical care unit of Purpan and on literature we hypothesize that a combined thoracic echography score could be of interest. We make the hypothesis that the use of a score based on thoracic combined echography (ETC = cardiac, pulmonary and diaphragmatic) allows to predict the failure of respiratory weaning in cardiac surgery and allows to improve the characterization of the causes of this failure

Official Title
-----------------
Respiratory Weaning Following Cardiac Surgery. Potential Interest of Combined Thoracic Echography in the Characterization of the Failure Causes.

Conditions
-----------------
Respiratory Insufficiency

Intervention / Treatment
-----------------
* Other: Combined Thoracic Echography Record


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (> 18 years old) beneficiating of mechanical ventilation following cardiac surgery Weaning test period Patient insured under the French social security system Exclusion Criteria: Tracheostomy Neurological disorders Need for prophylactic non invasive ventilation. Global obstructive lung disease with a forced expiratory volume < 50%. Judicial protection Patient already included in a trial still running. Pregnancy

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 |
| --- | --- |
| Patient with mechanical ventilation<br>Patient will be followed with combined Thoracic Echography Record | Other: Combined Thoracic Echography Record<br>* This examination will be done to do the longitudinal follow-up of the patient<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of predictive value of combined Thoracic Echography (ETC) as assessed by difference in the ETC score before and after extubation |  | 1 hour after the weaning test and 48h after | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of predictive value of combined Thoracic Echography (ETC) as assessed T tube Test score difference between patient who succeed or failed the weaning test |  | H0 and 48h after the weaning test | 
| Evaluation of diagnostic value of combined Thoracic Echography (ETC) after failure to weaning test as assessed be ECT scores collected |  | H0, H1 and H48 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Respiratory weaning, Pulmonary ventilation
Analysis of the Fixation of the Proximal Biceps Tendon

Study Overview
=================
Brief Summary
-----------------
Ten randomly selected patients that have undergone an open proximal biceps tendon tenodesis with an EndoButton for bicipital pathology with Christopher Schmidt, MD, will be asked to participate in the study. The study will assess the tendon healing to bone through magnetic resonance imaging (MRI). Individuals will also be asked to fill a visual analog scale (VAS) pain and disability of the arm shoulder and hand (DASH) assessment tools. The variables for our objective will include age, hand dominance, gender and chronicity of symptoms prior to surgery, and other related surgical procedures.

Official Title
-----------------
Analysis of the Fixation of the Proximal Long Head of the Biceps Tendon

Conditions
-----------------
Disorder of Tendon of Biceps

Intervention / Treatment
-----------------
* Procedure: Open proximal biceps tendon tenodesis with an EndoButton


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergone open subpectoral proximal biceps tenodesis with the EndoButton Exclusion Criteria: No history of surgery or disability in the contra-lateral extremity Not a member of a legally restricted group or protected population No prior surgery or further surgery on the extremity of interest No condition preventing the individual from undergoing a MRI

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Proximal Biceps Tendon Tenodesis<br> | Procedure: Open proximal biceps tendon tenodesis with an EndoButton<br>* Surgical fixation for bicipital pathology<br>|

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
-----------------
Proximal Biceps Pathology
Immunogenicity and Safety Study of NBP606 in Healthy Toddlers

Study Overview
=================
Brief Summary
-----------------
This study will assess the immunogenicity and safety of booster vaccination with NBP606 compared to the existing commercial vaccine, when given concomitantly with routine pediatric vaccinations.

Official Title
-----------------
Multi-Center, Randomized, Double-Blind, Phase III Trial to Assess the Immunogenicity and Safety of Booster Vaccination With NBP606 in Healthy Toddlers (The Extension Study of NBP606_PCVI_III_2013)

Conditions
-----------------
Pneumococcal Infections

Intervention / Treatment
-----------------
* Biological: NBP606
* Biological: Prevnar13


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy infants who completed 3 doses of primary vaccination (NBP606_PCVI_III_2013), available for follow-ups during the study period. The LAR (Legally Authorized Representative) who understand the requirements of the study and voluntarily consent to participate in the study. Exclusion Criteria: Administration of other vaccines, except the ones provided in this study, within 1month prior to booster study Known hypersensitivity to any components of the pneumococcal vaccine Any confirmed or suspected immunosuppressive or immunodeficient conditions Coagulation disorder contraindicating IM(intramuscular) vaccination Participation to another study

Ages Eligible for Study
-----------------
Minimum Age: 12 Months
Maximum Age: 15 Months

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NBP606<br>13-valent pneumococcal conjugate vaccine | Biological: NBP606<br>* A single intramuscular injection into the thigh<br>|
| Active Comparator: Prevnar13<br>13-valent pneumococcal conjugate vaccine | Biological: Prevnar13<br>* A single intramuscular injection into the thigh<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with the targeted antibody concentration |  | 1 month after the booster vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric mean concentration ratio |  | 1 month after the booster vaccination |