linjc16/ctgov huggingface dataset:
MicroRNA as Markers in Testicular Cancer

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is establish the performance of miR371 in management of testicular cancer

Detailed Description
-----------------
The main objective of the study is to asses the sensitivity and specificity of microRNA-371a-5p (miR371) in detection of viable testicular germ tumour cells. To assess the utility of miR371 at orchiectomy, during treatment and surveillance and in early detection of recurrence.

Official Title
-----------------
MicroRNA-371 as Markers for Disease Activity and as a Tool to Monitor the Effect of Chemotherapy and Early Detection of Recurrence in Patients With Testicular Germ Cell Tumours

Conditions
-----------------
Testicular Germ Cell Cancer, Seminoma, Non-Seminoma Testicular Cancer, Stage I Testicular Cancer, Stage II Testicular Cancer, Stage III Testicular Cancer, Stage IV Testicular Cancer, Relapse Testicular Cancer

Intervention / Treatment
-----------------
* Other: Biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with suspected testicular cancer, referred to orchiectomy. Patients diagnosed with testicular germ cell cancer. Age 18-70 years of age. Must be able receive information and to consent. Exclusion Criteria: Other prior or concomitant malignancy (other than testicular cancer). Other diseases or conditions that hinder the ability to receive information and to participate in follow-up procedures.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Biomarker analysis|Blood collection. Blood samples will be collected at diagnosis, during surveillance, during treatment and every 3-6 months|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| miR371 as a biomarker in testicular germ cell cancer at orchiectomy | To estimate the sensitivity and specificity of miR371 in identifying viable tumour cells at diagnosis | 5 years | 
| miR371 as a biomarker in testicular germ cell cancer at RPLND | To estimate the sensitivity and specificity of miR371 in identifying viable tumour cells at RPLND | 5 years | 
| miR371 as a biomarker in testicular germ cell cancer during chemotherapy treatment | To estimate the performance of miR371 in monitoring of treatment efficiency (chemotherapy) | 5 years | 
| miR371 as a biomarker in testicular germ cell cancer and detection of recurrence | To estimate the performance of miR371 in (early) detection of recurrence | 5 years |
Psychophysical Characterization and Brain Correlates of Dentine Hypersensitivity

Study Overview
=================
Brief Summary
-----------------
Up to date, devices capable of delivering controlled, calibrated, non-contact cold air stimuli in a MR environment are unavailable for quantitative sensory testing. This project therefore aimed at designing and constructing a novel MR-compatible, computer-controlled cold air stimulation device that produces air puffs in a broad flow and cold temperature range. By means of this device, detailed psychophysically testing and subsequent brain scanning of dentine hypersensitivity (DH) subjects will be possible to gain new insights about DH mechanisms.

Official Title
-----------------
Psychophysical Characterization and Brain Correlates of Dentine Hypersensitivity

Conditions
-----------------
Dentine Hypersensitivity

Intervention / Treatment
-----------------
* Other: air puffs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age and between 18 - 60 Exclusion Criteria: Caries Defective restorations Full crowns Orthodontic bands Bleeding on probing and periodontal pockets deeper than 3 mm Subjects with gross periodontal disease or treatment of periodontal disease in the past 12 months.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Dentine hypersensitivity subjects<br> | Other: air puffs<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective ratings using the BORG scale | individual subject perception ratings will be recorded by means of an adapted BORG scale. For reliability, intraclass correlations will be used covering 3-4 measures within a 3-4-weeks period. | May 1, 2016 | 
| blood oxygenation level dependent (BOLD) response | Changes in blood oxygenation level (indirect measure of neural activity) will be recorded | October 1, 2016 |
The Difference Seen in Granulosa Cells and Immature Oocytes in IVF Treated Patients Sorted by Body Mass Index (BMI)

Study Overview
=================
Brief Summary
-----------------
This study aims to discover the connection between BMI and oocyte and granulosa consistencies.

Conditions
-----------------
Infertility, Female

Intervention / Treatment
-----------------
* Other: Laboratory study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infertile women undergoing IVF Consent to participate in study Exclusion Criteria: Fertility preservation due to cancer Endocrine disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- |
| BMI above 30<br>Oocytes and granulosa of infertile women with BMI above 30 | Other: Laboratory study<br>* Laboratory analysis to determine composition of granulosa and oocytes<br>|
| BMI below 30<br>Oocytes and granulosa of infertile women with BMI above 30 | Other: Laboratory study<br>* Laboratory analysis to determine composition of granulosa and oocytes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of composition of granulosa cells and oocytes | Laboratory measurement of lipid and cholesterol amounts, mitochondrial distribution and telomere length according to BMI levels | One year |
Placebo Controlled Study of ONO2506PO in the Presence of Riluzole in Patients With Amyotrophic Lateral Sclerosis (ALS)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if oral treatment with ONO-2506PO in patients diagnosed with ALS, who have had onset of muscle weakness within 14 months of randomization, could lead to the slowing of decline in respiratory function, functional status, muscle strength, quality of life and survival compared with placebo group.

Official Title
-----------------
A Multi-centre, Randomized, Double Blind, Placebo-controlled, Parallel Group Study to Investigate Efficacy and Safety of ONO-2506PO Compared to Placebo, in the Presence of Riluzole, to Patients Diagnosed With Amyotrophic Lateral Sclerosis (ALS), Who Have Had Onset of Muscle Weakness Within 14 Months of Randomization

Conditions
-----------------
Amyotrophic Lateral Sclerosis (ALS)

Intervention / Treatment
-----------------
* Drug: ONO-2506PO
* Drug: ONO-2506PO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of clinically possible, clinically probable laboratory-supported, clinically probable or clinically definite ALS (according to WNF EL Escorial diagnostic criteria, revised according to the Airlie House Conference 1998) Onset of muscle weakness within 14 months randomization Concomitant standard Riluzole therapy (50mg twice daily) Exclusion Criteria: Presence of a tracheotomy, mechanical ventilation or non-invasive ventilation Requirement for prescription drugs used for potential neuroprotective benefit -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 74 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: E<br>ONO-2506PO in the presence of Riluzole | Drug: ONO-2506PO<br>* 1200 mg QD / 18 months<br>|
| Placebo Comparator: P<br>Placebo in the presence of Riluzole | Drug: ONO-2506PO<br>* 0 mg QD / 18 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of decline of respiratory function determined as SVC over the 12 month treatment period |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | 12, 18 months | 
| Functional Assessment (ALSFRS-R) |  | 12, 18 months | 
| Muscle Strength (MRC muscle score) |  | 12, 18 months | 
| Quality of Life |  | 12, 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ONO-2506PO, Amyotrophic Lateral Sclerosis, ALS
Comparison of WaveLight Analyzer and Alcon LadarWave

Study Overview
=================
Brief Summary
-----------------
Comparison of repeated WaveLight Analyzer and Alcon LadarWave measurements in phakic and pseudophakic eyes.

Conditions
-----------------
Healthy, Keratoconus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy eyes or eyes with the study conditions Exclusion Criteria: age < 18, eye disorders other than mentioned above, participation in any other study,

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 |
| --- | --- |
| 1<br>non-operated healthy eyes | |
| 2<br>eyes 1 months following LASIK | |
| 3<br>eyes 3-6 months following LASIK | |
| 4<br>eyes with spherical monofocal IOLs more than 3 months postop | |
| 5<br>eyes with aspherical monofocal IOLs more than 3 months postop | |
| 6<br>eyes with toric monofocal IOLs more than 3 months postop | |
| 7<br>eyes with diffractive multifocal IOLs more than 3 months postop | |
| 8<br>eyes with phakic IOLs more than 3 months postop | |
| 9<br>eyes with keratoconus | |

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
-----------------
wavefront measurements of the entire eye
Paris Visual Learning Test: a New French Task for Assess Visual Learning and Memory to Multiple Sclerosis Patients

Study Overview
=================
Brief Summary
-----------------
Cognitive impairment affects up to 65% of multiple sclerosis (MS) subjects, especially memory function. Rothschild Foundation has developped the Paris Visual Learning and memory Test (PVLT). 165 healthy volunteers were studied for its normalization. The main objective of the present study is to assess the validity of PVLT by comparing MS patients' test results to a database including the test results of 280 healthy control subjects, following recommended international standards.

Official Title
-----------------
Paris Visual Learning Test (PVLT): a New French Task for Assess Visual Learning and Memory to Multiple Sclerosis Patients

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

Intervention / Treatment
-----------------
* Other: Paris Visual Learning Test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: multiple sclerosis 20-89 years old Exclusion Criteria: acute inflammatory stage of central nervous system (< 1 month) other neurological or psychiatric disease regular drug and/or alcohol consumption refusal to participate in the study no health insurance coverage patient under legal protection

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 89 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Paris Visual Learning Test|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| test score |  | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Paris Visual Learning Test, visual memory, criterion validity
Outcomes of a Deep Inferior Epigastric Perforator Flap Program

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to analyze an institution's experience with starting a subspecialized DIEP flap program.

Detailed Description
-----------------
The purpose of this study is to analyze an institution's experience with starting a subspecialized DIEP flap program and to determine whether other hospitals would benefit from instituting a similar program. Prior studies have compared the outcome from a DIEP flap program with that of TRAM flaps within the same center. Other studies have calculated the cost of a DIEP flap and its complication rate. However, no one has examined the overall effects of a subspecialized reconstruction program and its impact on a health center. In this study, we will determine if the institutionalization of a DIEP flap program has increased our center's rate of breast reconstruction, as well as evaluate its outcomes and overall financial viability.

Official Title
-----------------
Outcomes of a Deep Inferior Epigastric Perforator Flap Program

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intraductal carcinoma Lobular carcinoma Infiltrating ductal carcinoma Paget's disease BRCA positive Exclusion Criteria: Inflammatory carcinoma of the breast

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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 |
| --- | --- |
| Pre programmatic development<br>Patients who have undergone mastectomy for breast cancer prior to implementation of the deep inferior epigastric perforator flap microsurgical breast reconstruction program | |
| Post programmatic development<br>Patients who have undergone mastectomy for breast cancer after implementation of the deep inferior epigastric perforator flap microsurgical breast reconstruction program | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complication rate | complication rate | 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reconstruction rate | reconstruction rate | 6 years | 
| patient satisfaction | Breast Q, Michigan Breast Outcomes Survey | 6 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast reconstruction, DIEP flap
Pre-meal Protein Drink Improve Glycemic Regulation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate if a pre-meal drink containing proteins can positively influence glycaemic control in patients with type 2 diabetes mellitus. Comparison with a placebo is included.

Official Title
-----------------
Impact of a Pre-meal Protein Drink on Metabolic Markers and Glycemic Control in Patients With Type 2 Diabetes

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

Intervention / Treatment
-----------------
* Dietary Supplement: Pre-meal protein drink
* Other: Water drink


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed type 2 diabetes mellitus according to WHO criteria (1999) age between 30-80 years non well controlled diabetes with HbA1c-levels above 62 mmol/mol Exclusion Criteria: pregnant or risk of becoming pregnant severe disease psychological disease, dementia or mental disability that makes it impossible to retrieve informed consent of participation liver disease kidney malfunction (GFR <60 or aspartate transaminase (ASAT)/alanine transaminase (ALT) two times higher than the normal interval

Ages Eligible for Study
-----------------
Minimum Age: 30 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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre-meal protein drink<br>A dose of 100 ml is taken just before breakfast, lunch and dinner. | Dietary Supplement: Pre-meal protein drink<br> <br> |
| Placebo Comparator: Water drink<br>A dose of 100 ml is taken just before breakfast, lunch and dinner. | Other: Water drink<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | Glycated hemoglobin | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial glycemia | Meal challenge given at start and end of study with repeated blood glucose sampling over 2h. | 16 weeks |
Discovery of Novel Biomarkers of Dietary Exposure in the EPIC Calibration Study

Study Overview
=================
Brief Summary
-----------------
This proposal aims at identifying new biomarkers of dietary exposure using metabolomic approaches. This project is based on the European Prospective Investigation on Cancer and Nutrition (EPIC) Calibration Study and more particularly upon a subset of 494 men and women from 4 European countries (Germany, Greece, Italy and France). Urine and blood samples are analyzed by untargeted metabolomics.

Detailed Description
-----------------
Subjects participating in the study are characterized by the availability of one 24-hr urine sample, blood serum, 24-hr dietary recall (24HDR) and food frequency questionnaire (FFQ) data. The main objectives of the proposal are: To collect a set of high-quality metabolomic data containing rich information on the food-derived metabolome. To mine this data in different Metabolome-Wide Association Studies in order to identify food-derived metabolites discriminating consumers and non-consumers of various foods, nutrients and dietary patterns. To identify the food-derived metabolites characteristic of the consumption of the different foods/nutrients and dietary patterns.

Official Title
-----------------
Mining the Urinary and Serum Metabolome for Discovery of Novel Biomarkers of Dietary Exposure in the EPIC Calibration Study

Conditions
-----------------
Dietary Exposure

Intervention / Treatment
-----------------
* Other: Identify Biomarkers of Dietary Intake in Healthy Subjects


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Aged 30-70 Healthy Residing within Europe. Have donated one 24-hr urine sample, blood serum. Have filled one 24-hr dietary recall (24HDR) and food frequency questionnaire (FFQ). Exclusion criteria: 24-hr urine sample and 24-hr dietary recall not collected on a same day. Incomplete collection of 24-hr urine sample.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Identify Biomarkers of Dietary Intake in Healthy Subjects|Observational study. No intervention.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolite concentrations in plasma and urine | Food-derived Metabolite concentrations in plasma and urine are measured by high resolution mass spectrometry coupled to ultrahigh performance chromatography. | 1 day |