linjc16/ctgov huggingface dataset:
Risk Indicators of Sarcoidosis Evolution-Unified Protocol

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop prediction models that can prognosticate patients with sarcoidosis using clinical data and blood markers that can be obtained during a clinic visit.

Detailed Description
-----------------
The purpose of this study is to develop prediction models that can prognosticate patients with sarcoidosis using clinical data and biological markers that can be obtained during a clinic visit. Primary Aim/Objective The primary objective of this study is to determine which clinical features measured during a routine clinic visit are risk factors for progression of pulmonary sarcoidosis over the follow-up period in adults with pulmonary sarcoidosis. Secondary Aim/Objectives The secondary objective is to determine if blood biomarkers measured during a routine clinic visit can improve the risk assessment for progression of pulmonary sarcoidosis over the follow-up period. The investigators will measure two types of blood markers to achieve this goal: Clinically available blood markers that are available in most clinical labs Blood proteins and gene expression that reflect interferon inflammation and are not currently available as tests in clinical labs

Official Title
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Development of Clinical Prediction Models for Pulmonary Outcomes in Sarcoidosis

Conditions
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Sarcoidosis, Pulmonary

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Adults with a diagnosis of sarcoidosis over the age of 18 Case definition: we will follow the 1999 statement on sarcoidosis published by the American Thoracic Society for diagnosis which includes tissue biopsy confirmation and exclusion of alternative diagnoses including beryllium sensitization/chronic beryllium disease, mycobacterial, viral, and/or fungal infection Exclusion Criteria: Inability to tolerate study procedures as determined by the investigator Pregnant or breastfeeding Concurrent medical diagnoses that would influence the expression of biomarkers will be considered an exclusion criterion. This includes diseases such as common variable immunodeficiency, HIV infection, or autoimmune diseases Concurrent interstitial lung diseases such as hypersensitivity pneumonitis or idiopathic pulmonary fibrosis Hematocrit (Packed Cell Volume) < 25%

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- | --- |
| Mean Change in Forced Vital Capacity in Liters | Forced vital capacity (FVC) is the total amount of air in liters exhaled during a forced maneuver. | Baseline and 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sarcoid, lung, immune
Histomorphometry Analysis in Fertile and Infertile Patients

Study Overview
=================
Brief Summary
-----------------
To detect similarities and differences in the endometrium of fertile and infertile patients

Detailed Description
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morphometric and pathologyc analysis of the endometrium in fertile and infertile patients

Official Title
-----------------
Histomorphometry Analysis in Fertile and Infertile Patients

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Procedure: Hysteroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 41 years old regular menses infertility over 12 months Exclusion Criteria: previous uterine surgery use of contraceptive pills or injections less than 3 months from the inclusion in the study

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infertile<br>patients from our human reproduction center | Procedure: Hysteroscopy<br>* hysteroscopy with guided biopsies<br>* Other names: pipelle- cornier;|
| Active Comparator: Fertile<br>patients with comproved fertility | Procedure: Hysteroscopy<br>* hysteroscopy with guided biopsies<br>* Other names: pipelle- cornier;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glandular volume | verify the glandular volume in fertile and infertil patients during the implantation window | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| epitelial surface | to detect differences in the endometrium of fertile and infertile patients | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endometrium, infertility, uterus, histeroscopy
Effect of Multi-Purpose Solutions on Ex-Vivo Wetting Angles

Study Overview
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Brief Summary
-----------------
To clinically evaluate the effect of a new multi-purpose disinfecting solution compared to a marketed multi-purpose solution on wettability of soft contact lenses worn for 30 days.

Official Title
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Long-Term Effect of Multi-Purpose Solutions on Ex-Vivo Wetting Angles of Soft Contact Lenses

Conditions
-----------------
Contact Lens Care

Intervention / Treatment
-----------------
* Device: OptiFree Multi-Purpose Disinfecting Solution


Participation Criteria
=================
Eligibility Criteria
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Successful daily wear of FDA Group I or IV soft contact lenses for at least one week. Vision correctable to 20/30. Normal eyes - no current ocular abnormalities that prevent successful contact lens wear. No corneal surgery within the past 12 months. No systemic disease that affects that eye or that could be worsened by the use of contact lenses or solutions. No over-the-counter or prescription ocular medication.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: OptiFree Multi-Purpose Disinfecting Solution|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: |  |  | 
| Contact lens wetting angle measured ex-vivo |  |  | 
| Safety: |  |  | 
| Slit-lamp Findings: Eyelids and Conjunctiva; Cornea; Iris, Anterior Chamber |  |  | 
| Visual Acuity (Snellen) |  |  | 
| Adverse Events |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Contact Lens Care
Oxytocin in MRI-HIFU

Study Overview
=================
Brief Summary
-----------------
Capability of oxytocin in improving the efficacy of MRI-HIFU is studied. Patients undergoing MRI-HIFU treatment are given oxytocin during treatment and the efficacy of the treatment will be analysed by patient reported symptom questionnaires and imaging data.

Official Title
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Use of Oxytocin in MRI-HIFU Treatment

Conditions
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Fibroid, Adenomyosis

Intervention / Treatment
-----------------
* Drug: Oxytocin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing MRI-HIFU -treatment Patients assessed for suitability to MRI-HIFU treatment willingness to participate in trial Exclusion Criteria: Known allergy to Syntocinon/oxytocin Elevated blood pressure ischemic heart disease Long QT- interval

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients treated with oxytocin during MRI-HIFU<br> | Drug: Oxytocin<br>* Oxytocin infusion during MRI-HIFU treatment<br>* Other names: MRI-HIFU;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NPV | non perfused volume (percentage of fibroid destroyed) | up to one year | 
| duration of MRI-HIFU | duration of MRI-HIFU treatment | up to one year | 
| UFS-Qol | Uterine fibroid symptom severity and quality of life (patient quality of life questionnaire) | 12 months after HIFU treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oxytocin, MRI-HIFU, fibroid, adenomyosis
Cytokines and Cognitive Decline in Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
Amyloid plaques and neurofibrillary tangles are the 2 well-known etiopathological hallmarks of Alzheimer's disease (AD). Beside these 2 lesions, inflammation response is described in the brain of patients with AD. The main objective of our study is to analyse the correlation between the value of plasma cytokines (interleukin 1, 6, TNFα and chemochine Rantes) and the rapidity of the cognitive decline in AD over a 2-year follow-up. Secondary objectives include: the predictive value of the cytokines on the cognitive decline after 6 months and one year of follow-up., of the patients include 150 patients with AD (MMSE: 16-25) correlation between plasma cytokines levels and expression of the protein kinase PKR (involved in death cell) in blood mononuclear cells.

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Other: blood test and cognitive tests


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Alzheimer's disease (AD)patients MMSE score: 16-25 Written informed consent Exclusion Criteria: AD patients with specific treatment for AD before inclusion MMSE score under 16 or over 25 at inclusion patients with anti-inflammatory drugs (non steroids or corticosteroids) or immunosuppressive agents Patients with acute disease (infectious disease, rheumatologic disease) or chronic disease (malignancy, infectious, rheumatologic disease) that could interact with plasma cytokines level Patients with a life threatening disease
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Intervention Model: Single Group Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: blood test and cognitive tests|Specific cognitive tests are performed at day 1, month 6, one year and 2 years Specific Blood samples tests are performed at inclusion, 1 years and 2 years|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Peripheral Blood Biomarkers in Idiopathic Interstitial Pneumonias

Study Overview
=================
Brief Summary
-----------------
We hypothesize that a peripheral blood biomarker or biological signature (gene or protein expression pattern) of idiopathic interstitial pneumonias (IIPs) will simplify and improve the accuracy of diagnosis of IIP and diagnose individuals at an earlier, more treatable, stage of their disease.

Detailed Description
-----------------
The Broad Challenge Area addressed in this proposal is (03) Biomarker Discovery and Validation, and the Specific Challenge Topic is 03-HL-101 (Identify and validate clinically relevant, quantifiable biomarkers of diagnostic and therapeutic responses for blood, vascular, cardiac, and respiratory tract dysfunction). Idiopathic interstitial pneumonia (IIP) is a lung disease(s) that primarily affects the elderly, but is present in all age groups. IIP causes respiratory insufficiency and is often fatal. In about half of the patients, the diagnosis requires an invasive lung biopsy which can cause complications, and is not always accurate. The current diagnostic tools for IIP are inadequate. In addition to inaccurate diagnosis, they are very costly, and often result in delayed diagnosis and treatment. The challenge(s) we intend to address in this proposal is to improve the accurate and early diagnosis of idiopathic interstitial lung pneumonia (IIP), and to improve the ability to differentiate the subtypes of idiopathic interstitial pneumonias (IIPs) by developing peripheral blood biomarkers.

Official Title
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Genetics, Genomics, and Proteomics of Idiopathic Interstitial Pneumonias: Identification of Susceptibility Genes, Biomarkers, and Molecular Phenotyping

Conditions
-----------------
Idiopathic Interstitial Pneumonias

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sporadic cases of Idiopathic Pulmonary Fibrosis and other types of Idiopathic Interstitial Pneumonias. Family members ( with or without clinical disease) with a family history of pulmonary fibrosis. Exclusion Criteria: None.

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 |
| --- | --- |
| Sporadic (idiopathic) or familial interstitial pneumonia<br>We are recruiting patients with Idiopathic Pulmonary Fibrosis and other types of Idiopathic Interstitial Pneumonias that occur sporadically or familial (2 or more affected individuals in a family). Participation can be done by mail or visiting Duke University Medical Center (Durham, NC)or National Jewish Health (Denver, CO). | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Ovarian Tumor Biopsies to Study Response to Treatments

Study Overview
=================
Brief Summary
-----------------
This is a research study to look at differences in tumor tissue from ovarian cancer patients that may help to determine response and resistance to treatments.

Detailed Description
-----------------
Ovarian cancer participants will be asked to have two tumor biopsies during the research study. The first biopsy will be done prior to receiving the participants' assigned treatments as a part of their cancer care and the second biopsy will be done about 3-7 days after starting treatment. Participants who will undergo neoadjuvant treatment and then surgery, will also have their tumor tissue collected during surgery. Participants whose disease worsens while on treatment will also be asked to have an additional, optional tumor biopsy. The tumor tissue samples will be studied to look at certain proteins and enzymes, including enzymes called kinomes, that may be important in determining response and resistance to the treatment that participants will receive as a part of their cancer care.

Official Title
-----------------
Paired Biopsies to Develop a Cellular Signature

Conditions
-----------------
Epithelial Ovarian Cancer

Intervention / Treatment
-----------------
* Procedure: Blood Draw
* Procedure: Tumor Tissue Biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years. Histological diagnosis of epithelial ovarian cancer Eastern Cooperative Oncology Group (ECOG) performance status ≤2. Life expectancy of greater than 3 months Diagnosis of epithelial ovarian cancer undergoing chemotherapy as part of standard care or a clinical trial OR receiving a targeted therapy with a targeted agent Must be agreeable to paired biopsies Must have disease amenable to paired biopsy. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Any contraindication to biopsy Need for anticoagulation that cannot be interrupted

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Epithelial ovarian cancer<br>Whole blood sample collection Up to 3 fresh tumor tissue core biopsies Tumor tissue sample taken from tumor tissue already removed from surgery (if surgery is planned) | Procedure: Blood Draw<br>* CA125 and ctDNA<br>Procedure: Tumor Tissue Biopsy<br>* Only collected at time of surgery if patient undergoes surgical debulking<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pearson correlation for changes between kinome and CA125 |  | 5 years | 
| Paired T-test for differences in kinome between responders and non-responders |  | 5 years |
DISCOGEL ®: Evaluation of the Procedure DISCOGEL ® in Lumbar Radiculopathy on Slipped Disc

Study Overview
=================
Brief Summary
-----------------
Lumbar disc herniation is the most important and frequent affection in rheumatology. The first treatment is based on an non-steroidal anti-inflammatory drugs.Physiotherapy also is used.But when there is no efficient result, it's usual to propose to the patient corticoid injection, percutaneous intervention or arthrodesis. Recently DISCOGEL® is a medical device used for lumbar disc herniation. However there is no studies evaluating the benefit and the efficiency of this technic. Since a few years, the rheumatology service of GHPSJ practise this technic using DISCOGEL® with patient resistant to the medical treatment . So the aim is to evaluate the benefit of DISCOGEL® retrospectively.

Official Title
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DISCOGEL ®: Evaluation of the Procedure DISCOGEL ® in Lumbar Radiculopathy on Slipped Disc

Conditions
-----------------
Hernia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age> 18 lumbar radiculalgy lumbar disc herniation described by MRI more than 6 weeks prescription of DISCOGEL Exclusion Criteria: medical history of surgery at the same stage patient under Clopidogrel or prasugrel

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Change From Baseline in Pain Scores on the Visual Analog Scale at 2 years |  | Baseline, 2 years |
Multiple Dose Escalating Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP1941

Study Overview
=================
Brief Summary
-----------------
This study determined the safety of ASP1941 after a single and multiple once-daily doses for 10 days in healthy subjects. In addition, the Pharmacokinetics (PK) and Pharmacodynamics (PD) of ASP1941 were assessed.

Official Title
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A Double-blind, Placebo-controlled, Dose Escalating Study to Assess the Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of ASP1941 and to Explore the Effect of ASP1941 on Urine and Blood Glucose Levels in Healthy Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: ASP1941
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body weight between 60-100kg, body mass index (BMI) between 20-30 kg/m2, inclusive Exclusion Criteria: Fasting Plasma Glucose (FPG) > 6.4 mmol/l HbA1c > 6.2% Abnormal pulse of blood pressure at screening, as judged by the investigator

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ASP1941|Oral|
|Drug: Placebo|Oral|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability assessed by the incidence of adverse events, vital signs, physical examinations, 12-lead ECG and lab-tests |  | 31 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics assessed by the ASP1941 plasma concentration change |  | up to 96 hours after last dose | 
| Pharmacodynamics assessed by the ASP1941 glucose concentration changes in blood and urine |  | up to 96 hours after last dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ASP1941, Diabetes Mellitus, Multiple ascending doses, Healthy subjects