linjc16/ctgov huggingface dataset:
Risk Minimisation Study for Diane-35 and Its Generics

Study Overview
=================
Brief Summary
-----------------
The study will be an observational, cross-sectional study of knowledge, understanding, and self-reported behavior among a sample of physicians with recent experience in prescribing Diane-35 or its generics in a total of five European countries. The primary objective of this study is to measure physician knowledge and understanding of the key information contained in the Diane-35 educational material: Patient information card, and Prescribers' Checklist. Specifically, the following objectives will be addressed: Investigate whether physicians have received any educational material related to Diane-35 or its generics Assess physicians' knowledge and understanding of key safety information pertaining to the patient information card Assess physicians' knowledge and understanding of key safety information pertaining to the following areas: Contraindications relevant to thromboembolism Risk factors for thromboembolism Signs and symptoms of thromboembolism

Official Title
-----------------
Study to Evaluate Physician Knowledge of Safety and Safe Use Information for Diane-35 and Its Generics in Europe: An Observational Post-Authorisation Safety Study

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Drug: Cyproterone acetate 2mg/ethinylestradiol 35 μg (Diane-35)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Physicians eligible to participate will have recently prescribed (e.g., within previous 6 months) Diane-35 or its generics

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 |
| --- | --- |
| Cyproterone acetate 2mg/ethinylestradiol 35 μg (Diane-35)<br>Prescribers of Diane-35 who agree and fulfill the criteria inclusion to participate in the survey | Drug: Cyproterone acetate 2mg/ethinylestradiol 35 μg (Diane-35)<br>* Cyproterone acetate 2mg/ethinylestradiol 35 μg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The knowledge of the physician concerning Diane-35 | The knowledge will be assessed based on a questionnaire with 22 questions which wil assess physician knowledge on key information contained in the Diane-35 educational material including patient information card, prescribers' checklist | Day1 |
Keratoconus - Biomarkers and Questionnaire

Study Overview
=================
Brief Summary
-----------------
The biomarker study adds to our previous study on biomarkers in tear fluid. In this study the investigators examine wether the biomarker levels are in correlation with the disease level and duration of disease. The questionnaire study focuses on the patients perspective. With a validated questionnaire fore keratoconus patient it examine the patients self.-evaluated visual challenges and quality of life

Official Title
-----------------
Keratoconus - Biomarkers and Questionnaire

Conditions
-----------------
Keratoconus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Keratoconus residint in the Central Denmark Region Exclusion Criteria: Other eye diseases Ocular traumas.

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- |
| age 15-25 years<br>Ophthalmic examination, VA measure, contrast vision, pentacam measurement, Tear fluid, saliva and blood samples | |
| age 25-35 years<br>Ophthalmic examination, VA measure, contrast vision, pentacam measurement, Tear fluid, saliva and blood samples | |
| age 35-45 year<br>Ophthalmic examination, VA measure, contrast vision, pentacam measurement, Tear fluid, saliva and blood samples | |
| > age 45 year<br>Ophthalmic examination, VA measure, contrast vision, pentacam measurement, Tear fluid, saliva and blood samples | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Protein levels in tear fluid, saliva and blood(plasma) |  | fall 2018 | 
| Ranch analysis of questionnaire |  | fall 2018 |
Evaluation of OCT and Visual Field Changes After Vitrectomy and ILM Peeling

Study Overview
=================
Brief Summary
-----------------
To evulate changes in VF and OCT after viterctomy associated with ILM peeling.

Detailed Description
-----------------
Macular epiretinal membrane (ERM) is a disorder of the vitreomacular interface characterized by ﬁbrocellular proliferation on the anterior surface of the internal limiting membrane (ILM) of the macula. Pars plana vitrectomy with ERM removal and inner limiting membrane peeling is the standard surgical treatment for an ERM. ILM peeling is performed to eliminate the scaffold for myoﬁbroblast proliferation and any microscopic ERM in order to prevent ERM recurrence. ILM peeling is indicated for other pathologies other than ERM such as, diabetic macular edema, and macular hole. ILM peeling is a traumatic procedure that may have many effects on the underlying inner retinal layers that may lead to changes in retinal function. Retinal edema, eccentric scotoma, dissociation of the nerve fiber layer, iatrogenic punctuate chorioretinopathy, and subretinal, retinal, and vitreous hemorrhage are well described secondary to the surgical trauma of peeling in addition to stain toxicity. Investigation of these changes may assist in aiding the development of minimally traumatic techniques for ILM removal . Evaluation of functional changes may include visual field and Multifocal electroretinography assessment. Visual field defect after vitrectomy a well known post operative complication usually in eyes that underwent fluid air exchange, the cause of visual field defect remain unclear. Optical Coherence Tomography (OCT), imaging is done to evaluate inner retinal layers after ILM peeling,High myopic eyes might develop more severe, scattered inner retinal defects after ILM peeling.

Official Title
-----------------
Evaluation of OCT and Visual Field Changes After Vitrectomy and ILM Peeling

Conditions
-----------------
ILM Peeling

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1-Idiopathic ERM, Primary full thickness macular hole, Lamellar macular hole, and Vitromacular traction. Exclusion Criteria: 1-Patients with a secondary ERM, diabetic retinopathy, venous occlusion, retinal detachment, uveitis, and trauma. 2-Other ocular pathologies that could interfere with the functional results dense cataract , glaucoma, and previous retinal surgery.

Ages Eligible for Study
-----------------
Maximum Age: 80 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 |
| --- | --- | --- |
| BCVA | ILM peeling | 6 months |
Microbiome and Mycobiome Registry of Volunteers With and Without Autism Spectrum Disorder

Study Overview
=================
Brief Summary
-----------------
Analyze, describe, and understand how the human gut microbiome (i.e. bacteriome and mycobiome) and Autism Spectrum Disorder (ASD) are related.

Official Title
-----------------
Microbiome and Mycobiome Registry of Volunteers With and Without Autism Spectrum Disorder

Conditions
-----------------
Autism Spectrum Disorder

Intervention / Treatment
-----------------
* Other: Microbiome and Autism Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Volunteers > 2 years of age Able to list all medical conditions and medications when applicable. Have already donated a stool sample to BIOHM™. Exclusion Criteria: Volunteers < 2 years of age

Ages Eligible for Study
-----------------
Minimum Age: 2 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: Microbiome and Autism Questionnaire|The questionnaire will be administered to collect demographic data (i.e. sex, age, race, and ethnicity) of the volunteers. Additionally, it will ask for the volunteers to identify whether or not they have autism spectrum disorder and what other medical conditions they have and what medications (e.g. prescribed, over the counter, herbal; etc.) that they take.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize the microbiome [bacteria and fungal community] | Identifying relative abundance of individual bacterial and fungal members. | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
autism, microbiome, mycobiome, bacteria, fungi
ConfirmMDx Assay in Multiparametric MRI (mpMRI) PIRADS Scored Lesions After a Negative MR/US Fusion Biopsy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if the ConfirmMDx assay is useful in finding prostate cancer in patients who are at increased risk for prostate cancer based on elevated PSA and prostate lesion identified on mpMRI.

Official Title
-----------------
ConfirmMDx Assay is Multiparametric MRI (mpMRI) PIRADS Scored Lesions After a Negative MR/US Fusion Biopsy

Conditions
-----------------
Prostate Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prior documented elevated PSA (> 4.0 ng/ml) MRI lesion based on PIRADS scoring within the past 3 years Completed MR/US fusion prostate biopsy with concurrent systematic biopsy for PIRADS score 2-5 with negative pathological findings completed subsequent ConfirmMDx assay (regardless of result). The most recent biopsy can be within 4 years if ConfirmMDx already completed. May have had prior negative biopsy sessions prior to the most recent MR/US fusion biopsy Must be able to stop anticoagulation/antiplatelet therapy 5-7 days prior to obtaining biopsy Ability to give informed consent Exclusion Criteria: Any metastatic cancer Any prostate cancer Active infection: urinary tract infection or prostate infection precluding prostate biopsy Anal stenosis or severe anal disease preventing prostate biopsy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All Participants<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of prostate cancer based on rebiopsy of lesions on multiparametric MRI (mpMRI) following a negative MR/US fusion biopsy with concurrent systematic biopsy with correlation of ConfirmMDx assay testing performed on negative MR/US fusion biopsy |  | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of PIRADS scores with ConfirmMDx testing outcomes |  | baseline | 
| Correlation of prostate cancer detection on re-biopsy with ConfirmMDx testing outcomes |  | baseline | 
| Compare prostate cancer detection rates for repeat MR/US fusion biopsy after prior negative biopsy |  | baseline |
Phase II Trial of Thalidomide in Refractory/Relapsed Diffuse Large B-Cell Lymphoma and Hodgkin's Disease

Study Overview
=================
Brief Summary
-----------------
Patients who have relapsed or refractory large B-cell lymphoma are being asked to take part in this study. The purpose of this study is to find out what effects (good and bad) the drug thalidomide has on patients and the lymphoma.

Detailed Description
-----------------
Patients who have relapsed or refractory large B-cell lymphoma are being asked to take part in this study. This research is being done because current treatment does not help everyone with this disease. The purpose of this study is to find out what effects (good and bad) the drug thalidomide has on patients and the lymphoma. Thalidomide has been shown to have activity against other cancers but is not approved by the FDA for treatment of lymphoma. Thalidomide prevents growth of new blood vessels that allow cancer cells to receive nourishment and spread. Another reason for doing the study is that researchers want to learn more about how the drug works and whether some patients respond better than others.

Official Title
-----------------
Phase II Trial of Thalidomide in Refractory/Relapsed Diffuse Large B-Cell Lymphoma and Hodgkin's Disease

Conditions
-----------------
B-Cell Lymphoma, Hodgkin's Disease

Intervention / Treatment
-----------------
* Drug: Thalidomide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with an expected survival period of 6 months or greater and who have been diagnosed with any stage of diffuse large B-cell lymphoma or Hodgkin's disease will be eligible to participate in this study. Final eligibility will be determined by the health professionals conducting this trial. Exclusion Criteria: Women who are pregnant, lactating or who refuse to have a pregnancy test will not be eligible for this study. Also, patients with an active infection, or a history of current or previous deep vein thrombosis and/or currently receiving anticoagulant therapy for deep vein thrombosis will be excluded from participation in this study. Final eligibility will be determined by the health professionals conducting this trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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
-----------------
B-Cell Lymphoma, Hodgkin's Disease
Study to Assess Clinical Outcomes in Chronic Hepatitis C Patients Previously Treated With Daclatasvir-Based Regimens

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess long-term outcomes in subjects previously treated with daclatasvir-based therapy for chronic Hepatitis-C (CHC)

Official Title
-----------------
A Long Term Off-treatment Follow-Up Study to Assess Clinical Outcomes in Chronic Hepatitis C Patients in China Previously Treated With Daclatasvir-Based Regimens

Conditions
-----------------
Hepatitis C

Intervention / Treatment
-----------------
* Other: Non-interventional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females 18 years of age or older at initiation of prior DCV-based therapy Previously treated with DCV (manufactured by BMS)-based therapy in combination with other HCV direct acting antivirals (DAAs) for at least 8 weeks Must enroll in this study within 12 months of end of treatment of DCV-based therapy or within 6 months of protocol availability at the clinical site for subjects treated in the AI447036 or AI447114 studies Exclusion Criteria: - N/A

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 |
| --- | --- |
| Patients Previously Treated with Daclatasvir-Based Regimens<br>Patients in China Previously Treated with Daclatasvir-Based Regimens | Other: Non-interventional<br>* Non-interventional<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hepatic disease progression events |  | up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Durability of virologic response | assessed by response in subjects previously treated with DCV-based therapy who achieved sustained virologic response at 12 or 24 weeks(SVR12/24) after the end of treatment | up to 5 years | 
| Change in liver stiffness | measured using elastography values | baseline up to 5 years | 
| Number of subjects with HCV sequence variants | presence of HCV sequence variants over time in subjects who failed to prior Daclatasvir(DCV)-based therapy | baseline up to 5 years | 
| Distribution of HCV retreatment patterns | distribution of HCV retreatment patterns including number of subjects receiving retreatment, retreatment regimen, retreatment duration and retreatment results | baseline up to 5 years |
Assessment of Food Environment and Physical Activity Opportunities in Three Neighbourhoods of Buenos Aires City

Study Overview
=================
Brief Summary
-----------------
Several environmental factors have contributed to the growing pandemic of obesity. It has been described that some characteristics of food and built environment have an influence on patterns of food consumption and physical activity of people in a certain place. We have designed a cross-sectional study to describe some aspects of the food environment (community and consumer) and the frequency, distribution and characteristics of the space available to perform physical activity in three neighborhoods of Buenos Aires city. Three neighborhoods of Buenos Aires (with representativity), from different socioeconomic strata, will be selected by convenience to conduct this study. The study will consist on three stages: first, the generation of the sampling frame of food stores, public and private spaces available for carrying out physical activity, and the development of a tool designed to evaluate the availability of healthy foods in supermarkets and grocery stores. Finally, a sample of those stores will be randomly selected for assessing the availability of selected foods. In Argentina, the knowledge of the food environment is limited. We believe that the information obtained in this study will contribute to a better understanding of the subject.

Official Title
-----------------
Assessment of Food Environment and Physical Activity Opportunities in Three Neighbourhoods of Buenos Aires City

Conditions
-----------------
Nutrition, Physical Activity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable Places and ambulant stands (only those that are located habitually in the same place) of food sale and / or drinks of any type. Public or private spaces destined for the accomplishment of physical activity. Exclusion Criteria: Places and stands of food sale and / or drinks and spaces for the accomplishment of physical activity not opened the public in general (as those who are inside schools, places of work, centers of health, etc.)
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
-----------------
Community nutritional environment, Physical activity
Time to Surgery - the Impact of Waiting Time on Outcome After Colorectal Cancer Treatment

Study Overview
=================
Brief Summary
-----------------
We aim to perform a register-based, observational cohort study to investigate whether it is safe to delay start of treatment with a curative intention after a colorectal cancer diagnosis. Our hypothesis is that delaying start of treatment until 4-8 weeks is as safe as starting treatment within four weeks after a colorectal cancer diagnosis.

Official Title
-----------------
Time to Surgery - the Impact of Waiting Time on Outcome After Colorectal Cancer Treatment

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Other: Time to treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with colorectal cancer 2008-2016 in Sweden Exclusion Criteria: None

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 |
| --- | --- |
| Colorectal cancer patients<br>Patients diagnosed with colonrectal cancer between 2008-2016 | Other: Time to treatment<br>* Treatment before or after 4 weeks after diagnosis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Overall survival | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay | Hospital stay | 90 days | 
| Re-operations within 3 months | Surgical procedures registered within 3 months after the procedure date | 90 days | 
| Re-admissions within 3 months | Readmissions registered within 3 months after the procedure date | 90 days | 
| Radical surgery | Defined as R0 resection | 90 days |