linjc16/ctgov huggingface dataset:
Partial Least Squares Regression Modelling for Glaucoma Detection

Study Overview
=================
Brief Summary
-----------------
A partial least squares regression model for visual field testing among glaucoma patients will be developed. In addition, microperimetry will be compared to conventional perimetry and reproducibility will be assessed.

Detailed Description
-----------------
Aim of this study is to develop a partial least squares regression model incorporating retinal nerve fiber layer (RNFL) and retinal ganglion cell layer (RGCL) measurements as well as visual field testing to represent a glaucoma expert opinion on the stage of glaucoma. In addition, microperimetry will be compared to conventional perimetry and reproducibility will be assessed.

Official Title
-----------------
Partial Least Squares Regression Modelling for Glaucoma Detection Using Retinal Nerve Fiber Layer, Ganglion Cell Layer and Visual Field Data

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Device: Microperimetry
* Device: automated visual field


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 21 and older written informed consent prior to surgery any glaucoma-associated changes in one or both eyes (i.e. increased intraocular pressure, optic disc changes, known visual field defects) in the glaucoma patients and the absence of any glaucoma associated changes in the healthy eyes group. Exclusion Criteria: Secondary glaucoma In case of pregnancy (pregnancy test will be taken in women of reproductive age)

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| Other: study arm<br>Microperimetry and automated visual field are performed at three different days | Device: Microperimetry<br>* Microperimetry is performed at three different days<br>Device: automated visual field<br>* Automated visual field ist performed at three different days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| partial least square regression | Development of a partial least squares regression model to detect glaucoma | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reproducibility | Comparison of reproducibility of microperimetry and visual field testing | one month | 
| Retinal nerve fiber thickness (RNFL) and the the retinal ganglion cell layer (RGCL) | The retinal nerve fiber layer thickness and the thickness of the retinal ganglion cell layer will be compared | one month | 
| Microperimetry versus visual field testing | Comparison of microperimetry and visual field testing | one month |
Post Marketing Surveillance Study in Patients With Idiopathic Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
Documentation of the effect of an direct or overlapping switch from another dopamine agonist to Sifrol® on motor function, psychopathological disturbances and mood, assessment of the reasons for the switch and the reasons for using Sifrol®, equivalent doses at the end of the switch and tolerability of Sifrol® in ambulatory patients suffering from idiopathic Parkinson's disease under routine conditions

Official Title
-----------------
Switch Post Marketing Surveillance Study in Patients With Idiopathic Parkinson's Disease

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Drug: Sifrol®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Idiopathic Parkinson's disease who are planned to undergo a switch from another dopamine agonist to Sifrol® Exclusion Criteria: Neurologists and psychiatrists are asked to consider the Summary of Product Characteristics (SPC) for Sifrol®
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Idiopathic Parkinson's disease patients<br> | Drug: Sifrol®<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reason for switch of therapy and reason for using Sifrol® | questionnaire | up to 8 weeks | 
| Type of switch (abrupt or overlapping) |  | up to 8 weeks | 
| Changes in motor function by means of 5-points rating scale | Short Parkinson's Evaluation Scale (SPES) | up to 8 weeks | 
| Changes in psychopathological memory disturbances by means of 5- point rating scale | Short Parkinson's Evaluation Scale (SPES) | up to 8 weeks | 
| Changes in psychopathological thought disorder disturbances by means of 5- point rating scale | SPES score | up to 8 weeks | 
| Changes in psychopathological depression disturbances by means of 5- point rating scale | SPES score | up to 8 weeks | 
| Changes of mood on seven visual analogue scales (VASs) | assessed by patient | up to 8 weeks | 
| Equivalent doses of Sifrol® | compared to previous treatment dosing, based on global clinical impression | after 8 weeks | 
| Global assessment of efficacy by investigator on a 5-point rating scale |  | after 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse drug reactions |  | up to 8 weeks | 
| Assessment of tolerability by investigator on a 5-point rating scale |  | after 8 weeks |
Bevacizumab + Paclitaxel + Capecitabine in Triple Negative Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Patients with triple negative metastatic breast cancer (HER2-, PR-, ER-) will receive bevacizumab, paclitaxel and capecitabine as a first line of treatment (possibility to have received adjuvant chemotherapy).

Official Title
-----------------
A Multi Phase II Clinical Trials Evaluating the Association of Bevacizumab With Weekly Paclitaxel and Capecitabine in First Line Treatment for Patients With Triple Negative Metastatic or Locally Advanced Cancer

Conditions
-----------------
Triple Negative Metastatic Breast Cancer

Intervention / Treatment
-----------------
* Drug: Paclitaxel
* Drug: Bevacizumab
* Drug: Capecitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female histologically confirmed adenocarcinoma of the breast ER-, PR-, HER2- disease Measurable disease Patients may received prior radiotherapy as adjuvant treatment or/and metastatic disease provided that they have progressive disease at study entry Exclusion Criteria: Prior chemotherapy for metastatic disease HER2 positive and/or hormonal receptor positive

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

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

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: Association bevacizumab paclitaxel capecitabine breast cancer<br>bevacizumab 10 mg/kg in IV, D1 and D15 paclitaxel 80mg/m2 in IV, D1 to D8 and D15 capecitabine 1600mg/m2/D, per os, D1 to D5, Weeks 1,2 and 3 | Drug: Paclitaxel<br>* 80 mg/m² weekly<br>Drug: Bevacizumab<br>* 10 mg/kg d1 d15<br>Drug: Capecitabine<br>* 800 mg/m² p.o. twice a day, D1 to D5 week 1, 2 & 3<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective response rate |  | 36 months for recrutment and 30 months for follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
triple negative, metastatic, breast cancer, First line chemotherapy
Evaluating the Effect of Senna in Uremic Pruritus

Study Overview
=================
Brief Summary
-----------------
Uremic pruritus remains one of the most frustrating and potentially disabling symptoms in patients with end stage renal disease. It affect up to 90 percent of patients with end stage renal disease. Several hypotheses have been postulated for the possible underlying etiology, but none is conclusive. Aside from kidney transplantation, which is only definitive treatment, therapeutic approaches have largely been empirical, and no firm evident-base treatments are available. The main goal of therapy remains to minimize severity of pruritus. In Iranian traditional medicine Cassia senna L. is used for healing uremic pruritus . In this study investigators considered to evaluate effect of Cassia senna L. in uremic pruritus by a double blind placebo control clinical trial. It is hypothesized that oral Cassia senna L. may attenuate uremic pruritus by decreasing serum IL-2, IFN-γ and TNF-α.

Official Title
-----------------
Phase II Study of the Effect of Senna Alexandrina Mill. on Uremic Pruritus and Serum IL-2, INF-δ and TNF-α Levels of Hemodialysed Patients

Conditions
-----------------
End Stage Renal Disease, Pruritus

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hemodialysis patients Suffering from pruritus for at least 6 weeks Have not responded to other drugs Exclusion Criteria: Dermatological disease Liver disease Metabolic disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Placebo Comparator: Placebo<br>Wheat | Drug: Placebo<br>* Placebo tablet/ 2 times per day<br>|
| Active Comparator: Senna<br>Senna | Drug: Senna<br>* (7.5 mg of sennosoides A and B) Senna tablet/ 2 times per day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of Pruritis, as measured by a visual analogue scale | A '0' score represented absence of pruritus and a '10' represented the greatest severity of symptoms. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum IL-2 level |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
End stage renal diseases, Hemodialysis, Uremic pruritus, Iranian traditional medicine, Cassia angustifolia
Multidisciplinary Shared Decision Making of Fertility Preservation in Young Women With Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Multidisciplinary shared decision making of fertility preservation in Young womenwith Breast Cancer (MYBC): A Pragmatic stepped wedge cluster randomised trial

Official Title
-----------------
Multidisciplinary Shared Decision Making of Fertility Preservation in Young Women With Breast Cancer

Conditions
-----------------
Young Womenwith Breast Cancer

Intervention / Treatment
-----------------
* Behavioral: Counseling to preserve fertility


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women aged 19 to 40 years old A person diagnosed with breast cancer by biopsy Those who don't have evidence of distant metastasis Eastern Cooperative Oncology Group(ECOG) performance status: 0-2 score Before registering for clinical trials, chemotherapy, radiation therapy, anti-hormone therapy, immunotherapy, and surgery are not performed A person who has fully understood and listened to the explanation of this clinical trial and then gave written consent Exclusion Criteria: Histologically, a person diagnosed with follicular or sarcoma Those with a history of breast cancer (including recurrent breast cancer) A person diagnosed with another cancer before breast cancer A person diagnosed with metastatic breast cancer A person who has a mental illness and has a hard time understanding clinical trials Those who plan to conduct follow-up observation elsewhere(to change of hometowm) Menopausal factors without menstruation after more than a year from the last menstrual date A pregnant woman Inappropriate for participation in clinical trials

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control group<br> | Behavioral: Counseling to preserve fertility<br>* Counseling to preserve fertility VS Control group<br>|
| Experimental: counseling theraphy<br> | Behavioral: Counseling to preserve fertility<br>* Counseling to preserve fertility VS Control group<br>|
| No Intervention: Retrospective data<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| selection ratio of fertility preservation procedure |  | selection ratio of fertility preservation procedure from Baseline to six years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The success rate of pregnancy |  | The success rate of pregnancy from Baseline to six years |
Leukapheresis to Obtain Lymphocytes for Studies on Antiretroviral Naive HIV-infected Patients

Study Overview
=================
Brief Summary
-----------------
To further investigate differences in the immunologic function of various lymphocyte subsets in HIV-infected patients who are treated early in their infection and during the chronic phase of the infection. Studies will also be done to further delineate the various antigen-specific and innate immune responses including characterization of soluble factors associated with primary HIV infection.

Detailed Description
-----------------
Primary HIV-1 infected and chronically infected individuals will be recruited and leukapheresis will be performed. This one year study requires that patients be apheresed once before initiating therapy and on two other occasions (at month 6 and month 12) after suppression of plasma viremia. Peripheral blood mononuclear cells will be isolated by sodium diatrizoate density centrifugation and subjected to immunologic and virologic studies.

Official Title
-----------------
Leukapheresis Procedures to Obtain Lymphocytes for Research Studies on Antiretroviral Naive HIV-infected Patients

Conditions
-----------------
Human Immunodeficiency Virus

Intervention / Treatment
-----------------
* Procedure: leukapheresis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult HIV-1 infected patient For primary infected patients anyone with an exposure to a known source of HIV infected material or individual, with symptoms and signs if present consistent with primary HIV infection, a negative ELISA, indeterminate Western blot for HIV and a positive HIV plasma RNA levels > 10,000 copies/mL by either RT-PCR or bDNA Chronic HIV-infected patients should have a positive ELISA and a confirmatory western blot and willingness to give informed consent for the storage of blood. Willingness to be able to make follow-up visits for apheresis at 6 and 12 months for those who undergo antiretroviral therapy Exclusion Criteria: Pregnant women

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

| Intervention/Treatment |
| --- |
|Procedure: leukapheresis|pack of cells as per protocol|

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
-----------------
primary HIV infection, chronic HIV infection
Study Comparing Sirolimus/Prograf vs Sirolimus/CsA in High-Risk Renal Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess whether in high-risk kidney transplant patients (patients whose previous kidney transplant failed, have a high PRA lab test result or are of African-American descent) that a combination of Rapamune with Prograf and steroids will prevent acute rejection as well as Rapamune and cyclosporine and steroids.

Official Title
-----------------
An Open-Label, Concentration-Controlled, Randomized, 12-Month Study of Prograf + Rapamune + Corticosteroids Compared to Cyclosporine,USP (Modified) + Rapamune + Corticosteroids in High Risk Renal Allograft Recipients

Conditions
-----------------
Renal Allograft Recipients

Intervention / Treatment
-----------------
* Drug: Rapamune


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients of African-American descent or patient with a history of multiple transplants and/or patients with a high panel reactive antibody lab test with a renal transplant from a cadaveric donor, a living unrelated donor or a living-related mismatched donor. Age >= 13 years, weight >= 40 kg Women must have a negative pregnancy test at study entry Exclusion criteria Multiple organ transplants or double kidney transplants (pediatric en-bloc or double adult) Active systemic infection, or localized major infection or known HIV Patients with residual kidney function >20 mL/min

Ages Eligible for Study
-----------------
Minimum Age: 13 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First biopsy-confirmed acute rejection, patient death or graft loss in the first 12 months following transplantation. First occurence of kidney graft loss or patient death in the first 12 months following transplantation. |  |  |
Changes in Elastic Properties of Descending Thoracic Aorta After Ascending Aorta Replacement

Study Overview
=================
Brief Summary
-----------------
The aim of our study was to evaluate the impact of aortic root replacement by a graft on the elastic properties of the descending thoracic aorta using cardiac Magnetic Resonance Imaging (MRI) and automatic post-processing. Nineteen patients were operated on an aortic root aneurysm and a cardiac MRI allowing aortic compliance measurement was performed before and after surgery. Images were acquired with a 1.5 T MRI with only one additional sequence to a conventional aortic MRI protocol.

Detailed Description
-----------------
Observational and retrospective trial on medical data only. The patients are operated of planned aortic root aneurysm without additional intervention. The pre and postoperative cardiac MRI are planned in standard of care.

Official Title
-----------------
Impact of Ascending Aorta Replacement by Graft on Elastic Properties of Descending Thoracic Aorta Evaluated by Cardiac Magnetic Resonance Imaging

Conditions
-----------------
Aortic Surgery

Intervention / Treatment
-----------------
* Procedure: Ascending aorta replacement with graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years Elective patient Ascending aorta replacement with graft Exclusion Criteria: Prior cardiac surgery Contraindication to performing cardiac MRI

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Ascending aorta replacement with graft|Patient with planned Ascending aorta replacement with graft|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aortic compliance of descending aorta (mm2/mmHg) | Aortic elastic properties of the descending aorta before and after aortic root replacement using cardiac MRI. Aortic compliance is a local measurement of elastic properties which is obtained with cardiac MRI images by computer processing. | post-operative cardiac MRI performing between 12 and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aortic compliance of ascending aorta (mm2/mmHg) | Aortic elastic properties of the ascending aorta before and after aortic root replacement using cardiac MRI. Aortic compliance is a local measurement of elastic properties which is obtained with cardiac MRI images by computer processing. | post-operative cardiac MRI performing between 12 and 24 months |