linjc16/ctgov huggingface dataset:
Genetic Analysis of Prostate Cancer to Identify Predictive Markers of Disease Relapse or Metastatic Evolution

Study Overview
=================
Brief Summary
-----------------
Developing a genetic study on localized or locally advanced prostate cancer. The aim of the study is to identify genomic alteration predictive of metastatic recurrence in the context of primary heterogeneity, by using the next generation sequencing (NGS) techniques. Identifying such biomarkers may be useful to detect a higher relapse risk, and thus lower the mortality rate.

Official Title
-----------------
Genomic Analysis in Localized or Locally Advanced Prostate Cancer. Identification of Biomarkers Predictive of Biochemical or Metastatic Recurrence

Conditions
-----------------
Prostatic Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients managed by radical prostatectomy for prostate cancer between 2000 and 2016. Follow up > 6 years Negative pre surgical extension assessment Prognostic Grade Groups (OGG) III-IV-V Biochemical recurrence defined by 2 consecutive PSA rises ≥ 0,2 ng/mL Metastasis positive imaging Exclusion Criteria: Neoadjuvant therapy Follow up < 6 years Prognostic Grade Groups (PGG) I-II Biochemical recurrence with metastasis negative imaging

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 |
| --- | --- |
| case group<br>patients with biochemical recurrence and positive imaging (case group) | |
| Control Group<br>patients without biochemical recurrence (control group) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The genetic alteration frequencies of TMPRSS2-ERG gene fusion |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of amplification of proto-oncogenes (MYC, AR, PIK3CA), |  | Baseline | 
| Frequency of mutations or deletions of tumor suppressor genes (PTEN, TP53, NKX3-1), |  | Baseline | 
| Frequency of point mutations modifying protein function (SPOP) |  | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
localized prostate cancer, prostatectomy, biomarkers, metastatic recurrence, genomic
Study on the Mechanism of Neurodevelopment Dysplasia of Fetal Brain Caused by ASNS Gene Mutation

Study Overview
=================
Brief Summary
-----------------
The investigators propose to analyze a brain sample and/or peripheral blood by single cell RNA seq from aborted embryos with ASNS mutation.

Detailed Description
-----------------
Congenital microcephaly could cause by gene mutation. Asparagine synthetase deficiency, which is caused by ASNS mutation, is a rare autosomal recessive neurometabolic disorder. It is characterized by severe developmental delay, congenital microcephaly, seizures. The investigators found a family with ASNS mutaion. The investigators propose to analyze a brain sample and/or peripheral blood by single cell RNA seq from aborted embryos with ASNS mutation.

Official Title
-----------------
Study on the Mechanism of Neurodevelopment Dysplasia of Fetal Brain Caused by ASNS Gene Mutation

Conditions
-----------------
Asparagine Synthetase Deficiency, Genetic Diseases, Inborn

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mutation Group: Having ASNS gene mutation by DNA exon sequencing. Control Group: No ASNS gene mutation by DNA exon sequencing. Exclusion Criteria: Mutation Group: N/A. Control Group: Having other gene mutation which also effect neurodevelopment.
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 |
| --- | --- |
| Mutation<br>Embryo or infant with ASNS mutation. | |
| Control<br>Embryo or infant without ASNS mutation. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of ASNS gene mutation on RNA expression in prefrontal cortex cells of brain tissue | Detect RNA expression in prefrontal cortex cells by single cell RNA sequencing. | 2018.06-2020.12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ASNS, single cell RNA seq, Neurodevelopmental Dysplasia,
Social Network Based Intervention to Reduce Lead Exposure Among Native American Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine whether adding an inter-generational component to an existing social network-based lay health advisor intervention increases its effectiveness in mobilizing a Native American community to respond to heavy metal contamination from lead and zinc mining.

Detailed Description
-----------------
Ottawa County, Oklahoma, the site of the research, was heavily mined for zinc and lead in the first half of this century. Mine tailings containing heavy metals are stored in large piles up to 200 feet in height. Ottawa County is home to 8 Indian tribes and much of the mine waste is on tribal land. Specifically, the study will: a) integrate existing Native American youth programs with the existing lay health advisor intervention (Society of Clan Mothers and Fathers) to form an inter-generational intervention, b) expand the existing lay health advisor intervention to address cadmium in addition to lead, c) use participatory research methods to involve tribal youth and adults in an air monitoring study, d) assess the extent to which the intervention contributes to belief, attitude and behavior changes that will reduce heavy metal exposure and absorption in Native American children; and e) assess the contribution of the intervention to creating changes in organizational, community, tribal and government (city, county, state, federal) capacity to address heavy metal contamination in Ottawa County, Oklahoma.

Conditions
-----------------
Lead Poisoning

Intervention / Treatment
-----------------
* Behavioral: Education on behaviors to reduce lead exposure


Participation Criteria
=================
Eligibility Criteria
-----------------
Children ages 1-6 Live in Ottawa County, Oklahoma

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 6 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Education on behaviors to reduce lead exposure|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
-----------------
Lead poisoning, Native Americans
A Study of Mircera in Renal Anemia Among Filipino Chronic Kidney Disease Patients

Study Overview
=================
Brief Summary
-----------------
This study will assess the efficacy and safety of once monthly administration of Mircera in Filipino patients with chronic kidney disease who are either on dialysis or predialysis, and not receiving erythropoiesis stimulating agents.Patients will receive Mircera at a starting dose of 0.6 micrograms/kg sc every 2 weeks, with dose adjustments until a target hemoglobin level is achieved, and then dosing will continue every 4 weeks. The anticipated time on study treatment is 3-12 months, and the target sample is <100 individuals.

Official Title
-----------------
An Open-label Study of the Effect of Mircera on Hemoglobin Levels in Filipino Chronic Kidney Disease Patients

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Drug: methoxy polyethylene glycol-epoetin beta [Mircera]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, >=18 years of age; chronic kidney disease; anemia (Hb >8 and <11 g/dL); regular dialysis or predialysis, not treated with ESA. Exclusion Criteria: transfusion of red blood cells during previous 8 weeks; poorly controlled hypertension; overt gastrointestinal bleeding, or other bleeding necessitating transfusion during previous 8 weeks; active malignant disease (except melanoma of skin).

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: methoxy polyethylene glycol-epoetin beta [Mircera]<br>* sc every 2 weeks at a starting dose of 0.6micrograms/kg;subsequently every 4 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in Hb >1.0g/dL from baseline, and Hb conc. >11g/dL without red blood cell transfusion, for dialysis patients;Hb conc >11-12 g/dL for pre-dialysis patients |  | 24 weeks after first dose, through week 25 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| >=60% responders with target Hb >11g/dL for dialysis patients; Hb conc >11-12g/dL for pre-dialysis patients;incidence of RBC transfusions; no. of patients with dose adjustments |  | At end of 24 weeks treatment |
Silesian Registry of Out-of-Hospital Cardiac Arrests

Study Overview
=================
Brief Summary
-----------------
Silesian Registry of Out-of-Hospital Cardiac Arrests (SIL-OHCA) which is an initiative of the Voivodeship Rescue Service in Katowice in cooperation with the Silesian Center for Heart Diseases in Zabrze is a prospective, population-based registry of out-of-hospital cardiac arrests (OHCA). The main aim of the SIL-OHCA is to asses the frequency of OHCA in the population of Upper Silesia and analyze prognostic factors for long-term survival in patients with OHCA.

Official Title
-----------------
Silesian Registry of Out-of-Hospital Cardiac Arrests

Conditions
-----------------
Out-Of-Hospital Cardiac Arrest

Intervention / Treatment
-----------------
* Other: cardiopulmonary resuscitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Out-of-hospital cardiac arrest treated by emergency medical services of Voivodeship Rescue Service in Katowice. Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: cardiopulmonary resuscitation|no pre-specified|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day survival or survival to discharge |  | 30 days | 
| Any return of spontaneous circulation | the occurence of any return of spontaneous circulation after cardiac arrest | from OHCA until transfer to the hospital or decision to withdraw CPR (assessed up to 24 hours after OHCA) | 
| Event survival | transfer to the hospital with sustained ROSC | within first 24 hours after OHCA | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OHCA, cardiac arrest, cardiopulmonary resuscitation
Effect of Externally Implantable Tissue Expansion Device on Scar Length

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess whether brief use of an externally implantable tissue expansion device following excisional skin cancer surgery will significantly reduce the diameter of the final wound defect, and hence the length of the final linear primary closure. The secondary objective is to assess the functional benefits, if any, associated with use of the tissue expander.

Official Title
-----------------
Effect of Externally Implantable Tissue Expansion Device on Scar Length

Conditions
-----------------
Skin Lesion

Intervention / Treatment
-----------------
* Device: Externally Implantable Tissue Expansion Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Subjects ages 18-80 years old Subjects who are undergoing an excision of a large cutaneous lesion Subjects with an immediate post-excision wound defect at least 2.5 cm in diameter Subjects undergoing surgery on the trunk or extremities The subject has willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator. Subjects who are willing to undergo no other treatments for the scars for the duration of the study. Exclusion Criteria Subjects with scalp wounds Subjects who are unable to understand the protocol or give informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Implantable Tissue Expansion Device<br>Will apply externally implantable tissue expansion device for 2 days | Device: Externally Implantable Tissue Expansion Device<br>* Will Apply Externally Implantable Tissue Expansion Device for 2 Days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surface area (in cm2) of subject's scar |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treating physicians will note any adverse effects |  | 3 months |
Fecal Microbiota Transplantation (FMT): PRIM-DJ2727

Study Overview
=================
Brief Summary
-----------------
The Fecal Microbiota Transplantation (FMT) product PRIM-DJ2727 is prepared from human stool from a healthy, screened donor. Requestors will contact the study team about the product (PRIM-DJ2727) by email, visit, or phone call. A screening list for donors will be provided to make sure that the list fits the requestor's requirements. A basic fee will be requested to recover the cost of making the product. After an agreement is made, a contract will be signed between the 2 parties. A week before the treatment, requestors will contact the study team for possible FMT product delivery. Delivery method will be confirmed for delivery by personnel (within 10 minutes driving distance) or by using FedEx services. Each delivered product will have an approved delivery form signed and dated by both the person who prepared the delivery and the person who received the package.

Conditions
-----------------
Recurrent Clostridium Difficile Infection, Multidrug-resistant Klebsiella Pneumoniae Urinary Tract Infection

Intervention / Treatment
-----------------
* Biological: Fecal Microbiota Transplantation (FMT) product PRIM-DJ2727


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: -

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Fecal Microbiota Transplantation (FMT) product PRIM-DJ2727|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Diagnosis of GABHS Tonsillitis - Comparison Between Culture From Tonsills and Culture From the Bucal Surface

Study Overview
=================
Brief Summary
-----------------
Diagnosis of Group A beta hemolytic strep tonsillitis - cultre of tonsills (gold standard) culture from bucal surface (test)

Detailed Description
-----------------
This study will examine 2 groups. first group of 50 children aged 3-18 years and the second group of adults aged 18-65 with a clinical diagnosis of tonsillitis and centor criteria of 2 or more (fever, exudates on tonsills, no cough, enlarged lymph nodes). In each patient we'll take 2 cultures - the first from the tonsills and the second from the bucal surface. both of them will be sent to MEGA-LAB . the treatment will be based only on the gold standrad culture from the tonsills.

Official Title
-----------------
Diagnosis of GABHS Tonsillitis - Comparison Between Culture From Tonsills and Culture From the Bucal Surface

Conditions
-----------------
Tonsillitis, Tonsillitis Streptococcal

Intervention / Treatment
-----------------
* Diagnostic Test: throat culture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: tonsills exudates Centor criteria - 2 or more Exclusion Criteria: tonsillectomy

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 65 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: patients<br>each patient will be reviewed twice - first time culture from the tonsills and the second culture from the bucal surface. | Diagnostic Test: throat culture<br>* throat culture - from the tonsills and from the bucal surface<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| positiveGABHS culture from bucal surface in comparisson to positive culture from tonsills | sensitivity and specificity of culture | each test will be cultures within 24-48 hours. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diagnosis, tonsillitis, streptococcus, GABHS
Observational Study To Evaluate Statins Patterns Of Use In Spain

Study Overview
=================
Brief Summary
-----------------
The present project is aimed at describing the statins prescription pattern in Spanish patients. It will also look into how adequate these prescriptions are accordingly to the recommendations given in Treatment Guidelines and in the Summary Product Information.

Official Title
-----------------
Statins Use Patterns in Spain

Conditions
-----------------
Dyslipidemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients receiving a new statin prescription (naïve patients) Patients having a change in their statin prescription (dose, switching, addition to another hypolipemic drug) Exclusion Criteria: Patients without enough information in the medical records to complete the fields required in the eCRF

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 |
| --- | --- |
| 1<br>Adults, with a new statin prescription or a change in their stain treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Current and previous hypolipemic treatment, dose and pattern |  | Retrospectively (information for the previous 6-months). Information collected once. | 
| Statin treatment start date, origin of the prescription, reasons for changes in prescription |  | Retrospectively (information for the previous 6-months). Information collected once. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Socio-demographic characteristics |  | retrospectively | 
| Total Cholesterol, HDL, LDL, Triglycerides, ALAT, Glucose, Creatine Kinase plasma levels |  | retrospectively | 
| Concomitant Treatments and Cardiovascular History |  | retrospectively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Statins, Dyslipidemia, Spain, Rosuvastatin, Naive, Switching, New statins prescriptions in Spain (naive patients and switching)