linjc16/ctgov huggingface dataset:
Measurement and Analysis of Macular Retinal Pigment Epithelium (RPE) Elevations With Cirrus HD-OCT vs. Color Fundus Photography

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to compare the areas designated as elevated retinal pigment epithelium (RPE) by the Cirrus HD-OCT versus those designated as drusen on color fundus photographs (CFPs).

Detailed Description
-----------------
This is a prospective, multiple site study. Ocular history and examination will be conducted on consented subjects to determine further participation in the study. Subjects qualified to continue will undergo color fundus photography and imaging of their study eye using the Cirrus HD-OCT.

Official Title
-----------------
Measurement and Analysis of Macular Retinal Pigment Epithelium (RPE) Elevations With Cirrus HD-OCT vs. Color Fundus Photography

Conditions
-----------------
Drusen Stage Macular Degeneration

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females 50 years of age or older diagnosed to have dry AMD with macular drusen. Drusen should not be combined with other lesions such as geographic atrophy (GA) or choroidal neovascularization. Able and willing to make the required study visits. Able and willing to give consent and follow study instructions. Exclusion Criteria: History of retinal surgery, laser photocoagulation, and/or radiation therapy to the eye. Evidence of other retinal diseases of the eye, including wet AMD, diabetic retinopathy, diabetic macular edema, or significant vitreomacular traction upon dilated examination, or upon evaluation of retinal photos. Thick media opacity or inability to fixate that precludes obtaining acceptable scans. Concomitant use of hydrochloroquine and chloroquine. Unable to make the required study visits. Unable to give consent or follow study instructions.

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- |
| Dry AMD with macular drusen<br>Patients diagnosed with dry AMD with macular drusen | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare area measurements of elevated RPE as observed in the Cirrus HD-OCT versus those designated as drusen on color fundus photographs. |  | Study was released before December 1, 2012 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe the clinical factors that affected the automated segmentation of elevated RPE by the Cirrus HD-OCT. |  | Study was released before December 1, 2012 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drusen, Dry AMD, OCT, Imaging
Sun Protection Factor Assay

Study Overview
=================
Brief Summary
-----------------
To evaluate the Sun protection factor efficacy on human skin.

Official Title
-----------------
Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay (UVAPF), Minimal Persistent Pigment-Darkening Dose (MPPD)

Conditions
-----------------
Sunscreening Agent

Intervention / Treatment
-----------------
* Drug: Coppertone (BAY987517)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing. Male and female Aged between 18-70 years old. Good health as determined from the HRL SHF(Self History Form) Signed and dated Informed Consent Form Signed and dated HIPAA (Health Insurance Portability and Accountability Act) Form An unbambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose) Exclusion Criteria: Subjects on test at any other research laboratory or clinic. Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light. Pre-existing dermatologic conditions which have been diagnosed by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study. Pre-existing other medical conditions (e.g. adult asthma. diabetes). Treatment with antibiotics within two weeks prior to initiation of the test. Chronic medication which could affect the results of the study. Known pregnant or nursing women. Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.

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

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

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: BAY987517<br>Each test site area is divided into test subsite areas that are approximately at least 0.5 cm*2. The application of test material is 2 mg/cm*2. Thus, each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. | Drug: Coppertone (BAY987517)<br>* Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation number - SR15-46-Z13-072)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal Erythema Dose (MED) |  | Up to 15 minutes | 
| Minimal Persistent Pigment Darkening Dose (MPPD) |  | Up to 15 minutes |
Oral Paracetamol as Preemptive Analgesia for Labor Pain

Study Overview
=================
Brief Summary
-----------------
It is a double blinded randomized control trial assessing the use of Oral paracetamol in managing the intrapartum pain.

Detailed Description
-----------------
It is a double blinded randomized control trial comparing the use of Oral paracetamol to placebo in managing the intrapartum pain.

Official Title
-----------------
Oral Paracetamol as Preemptive Analgesia for Labor Pain

Conditions
-----------------
Labor Pain

Intervention / Treatment
-----------------
* Drug: paracetamol
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primigravida The gestational age between 37- 42 weeks Not seeking analgesia Singleton pregnancy vertex Spontaneous onset of labour 1st stage of labour (less than 5 cm) Exclusion Criteria: Extreme of age (below18-above 40) Multiparous Multiple gestation Malpresentation Congenital or acquired pelvic abnormalities(eg. Poliomyelitis) Any medical disorder with pregnancy Induction of labour Advanced 1st stage > 5 cm Use of any other kind of analgesia before recruitment in the study Scared uterus Fetal distress

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: paracetamol<br>paracetamol 2 tablets1000mg PO. | Drug: paracetamol<br>* 500 mg oral tablet<br>|
| Placebo Comparator: placebo<br>placebo 2 tablets containing Starch PO | Drug: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | To document the efficacy of oral paracetamol, in pregnant women in labor, as demonstrated by the degree of pain relief and need for additional analgesia during the labor process and the early postpartum period. | intrapartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | To document safety and evaluate adverse events recorded during the study either maternal or fetal. | Start of medication till 24 hours postpartum | 
| Duration of labor | To assess the effect of the duration of labor. | Start of medication till delivery of fetus. |
Custom Guides for Total Knee Arthroplasty (TKA)

Study Overview
=================
Brief Summary
-----------------
The goal of the study is to know if the reconstruction of the lower limb mechanical axis and the patient knee function is improved after Total Knee Arthroplasty (TKA) using patient specific instruments.

Official Title
-----------------
Prospective Cohort of FIRST TKA With Custom Guides

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Device: Custom guides


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for a TKA Informed signed consent
Sexes Eligible for Study
-----------------
All

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

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: Register<br>Register | Device: Custom guides<br>* Symbios custom guides for TKA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in mechanical axis of the lower limb | Mechanical axis of the lower limb as defined by the X-Ray evaluation form of the Knee Society Score | Pre-operatively (up to 3 months);6months | 
| Changes in gait | Spatio temporal parameters of the gait | Pre-operatively (up to 3 months); 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Knee osteoarthritis
Genetics of Fibromyalgia

Study Overview
=================
Brief Summary
-----------------
The Fibromyalgia Family Study identifies and collects blood samples from families with two or more members affected with Fibromyalgia Syndrome (FMS). The primary goal of the study is to identify genes that predispose people to FMS and/or symptoms related to FMS; identifying these genes may lead to a better understanding of the disease and more effective treatments.

Detailed Description
-----------------
FMS predominantly affects women and is characterized by chronic widespread musculoskeletal pain, fatigue, sleep disturbance, and multiple tender points on physical examination. The pathophysiological mechanisms underlying FMS are not clearly understood, but neuroendocrine factors seem to be of major importance. Studies of familial association suggest that genetic factors play a role in FMS. This study will establish patterns of genetic linkage in families with FMS. Participating family members will undergo a brief physical exam (including tender point exam), donate a blood sample, and complete a detailed questionnaire that includes experience with pain, fatigue, depression, bowel symptoms, headache, anxiety, and physical limitations. Measurements of serum serotonin and related compounds will also be obtained. To detect genetic factors, a genome-wide linkage scan using 405 microsatellite markers will be performed.

Official Title
-----------------
Fibromyalgia Family Study Registry

Conditions
-----------------
Fibromyalgia, Irritable Bowel Syndrome, Chronic Fatigue Syndrome, Depression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Diagnosed with fibromyalgia according to the criteria of the American College of Rheumatology Have at least one living family member who has also been diagnosed with fibromyalgia No other major rheumatological disease

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain, Fatigue, Sleep, Depression, Irritable Bowel Syndrome, Chronic Fatigue Syndrome
Cardiac Allograft Rejection Gene Expression Observational (CARGO) II STUDY

Study Overview
=================
Brief Summary
-----------------
The Cardiac Allograft Rejection Gene Expression Observational (CARGO) II Study is designed to provide independent evidence of the clinical performance of the non-invasive AlloMap test. Sensitive detection of cardiac allograft rejection and dysfunction is the basis for successful recipient management. The CARGO II Study will assess the correlation between the presence or absence of acute cellular rejection as determined by examination of endomyocardial biopsy specimens with results from the AlloMap Test. Of 17 participating transplant centers, 4 are in North America and 13 are in Europe.

Official Title
-----------------
Cardiac Allograft Rejection Gene Expression Observational (CARGO) II STUDY

Conditions
-----------------
Graft Rejection, Heart Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: New and existing allograft recipients All patients (age ≥ 18years) receiving post-transplant care at the enrolling centers Exclusion Criteria: Concurrent enrollment in a double-blind drug trial (immunosuppressive drugs).

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>Heart transplanted subjects. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Cellular Rejection(ACR)grades - ACR ISHLT Grades will be determined by centralized pathology reading. The associated AlloMap Test score will be correlated to the biopsy reading. |  | Scheduled clinic visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the AlloMap Test and novel gene expression algorithm in guiding management of steroids and calcineurin inhibitors based on the algorithm's capacity to predict future cellular rejection and future graft dysfunction. |  | more than 2 months following date of transplant | 
| Assessment of clinical utility of the AlloMap Test and novel gene expression algorithms in diagnosis and prediction of humoral rejection. |  | >2 months after date of transplant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
allograft, rejection, biopsy, gene, expression, cardiology, heart, transplant
Relationships Between Plasma PCSK9 Levels, LDL-cholesterol Concentrations and Lipoprotein (a) Levels in Familial Hypercholesterolemia

Study Overview
=================
Brief Summary
-----------------
Familial hypercholesterolemia (FH) is an autosomal codominant single gene disorder caused by mutations in the LDL receptor gene (LDLR) that disrupt the normal clearance of LDL particles from the plasma. Heterozygous patients (HeFH) present a two- to three-fold raise in plasma LDL-cholesterol (LDL-C) concentrations and coronary artery disease occurs earlier among HeFH carrying negative-receptor (NR) mutations as compared with HeFH subjects carrying defective-receptor (DR) variants. Proprotein convertase subtilisin/kexin type 9 (PCSK9) regulates LDL-C levels by binding to LDLR and by enhancing its intracellular degradation. The objective of this study is to examine to what extent variations in LDL-C and Lipoprotein (Lp) (a) concentrations are related to PCSK9 levels in a large French-Canadian cohort of HeFH subjects. The primary hypothesis is that that PCSK9 levels have a significant impact on LDL-C concentration variability and are associated with Lp(a) levels.

Official Title
-----------------
Relationships Between Plasma PCSK9 Levels, LDL-cholesterol Concentrations and Lipoprotein (a) Levels in Familial Hypercholesterolemia

Conditions
-----------------
Familial Hypercholesterolemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with familial hypercholesterolemia: Aged between 18-65 years Carrier of a mutation in the LDL receptor gene Controls: Aged between 18-60 years HDL-cholesterol > 1.1 mmol/L Triglycerides < 1.7 mmol/L Fasting blood glucose <6.1 mmol/L Normal blood pressure (<130/85) Exclusion Criteria: Subjects with a previous history of cardiovascular disease Subjects with Type 2 diabetes Were pregnant or nursing; Subjects with a history of cancer Subjects with acute liver disease, hepatic dysfunction, or persistent elevations of serum transaminases Subjects with a secondary hyperlipidemia due to any cause History of alcohol or drug abuse within the past 2 years hormonal treatment Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Controls<br> | |
| Familial hypercholesterolemia<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of PCSK9 on LDL-C concentrations |  | Week 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of PCSK9 on Lp(a) concentrations |  | Week 1 |
Observational Study for the Cytofluorimetric Analysis of Cerebrospinal Fluid in Non-Hodgkin's Lymphoma Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to define if flow cytometry has more sensitivity for detecting neoplastic cells in cerebrospinal fluid versus conventional cytology.

Detailed Description
-----------------
Aggressive B-cell non-Hodgkin's lymphoma (B-NHL), Lymphoblastic Lymphoma and Burkitt's Lymphoma are at high risk of CNS relapse. For this reason is recommended a prophylaxis therapy. This suggests that negative leptomeningeal localization patients at diagnosis are really positive and that would be a very high risk of CNS relapse subtype patients. It's very important detecting neoplastic cells in cerebrospinal fluid as soon as possible. This study will evaluate only patients that have been flow cytometry and cytology at diagnosis.

Official Title
-----------------
Observational Retrospective Multicenter Study for the Citofluorimetric Analysis of Cerebrospinal Fluid Vs Conventional Method in Patients With Aggressive Non-Hodgkin's Lymphoma Without Leptomeningeal Disease

Conditions
-----------------
Diffuse Large Cell Lymphoma, Lymphoblastic Lymphoma, Burkitt's Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Diffuse large cell lymphoma HIV positive, Lymphoblastic lymphoma, Burkitt's lymphoma, Mantle cell lymphoma blastoid type. DLCL patients who presented one risk factor for leptomeningeal involvement as: testis, bone marrow, orbit, palate, paranasal cavity or peridural disease localization, 2-3 age-adjusted IPI score with more than 1 extranodal site and LDH > normal. Patients with cytologic and flow cytometry on cerebrospinal fluid at diagnosis. Exclusion Criteria: 1. Patients with clinical or strumental evidence of meningeal localization disease.

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 |
| --- | --- | --- |
| Evaluation of diagnostic agreement of citofluorimentria flow in the research of lymphoma cells in the cerebrospinal fluid vs cell morphology. | Evaluation of diagnostic agreement of citofluorimentria flow in the research of lymphoma cells in the cerebrospinal fluid vs cell morphology. The second test will be performed independently and without the cytologist is aware of the outcome of the analysis by flow cytometry. | Evaluation at diagnosis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of all paper forms |  | 1 year |