linjc16/ctgov huggingface dataset:
Passive Enhanced Safety Surveillance of Stamaril® Vaccine in Korea

Study Overview
=================
Brief Summary
-----------------
This is a passive enhance safety surveillance (ESS) of Stamaril® vaccine in Korea. The objective is to collect suspected related adverse events following vaccination with Stamaril® in routine practice.

Detailed Description
-----------------
This ESS replaces the routing post-marketing surveillance required after product approval in Korea.

Official Title
-----------------
Passive Enhanced Safety Surveillance of the Live Attenuated Yellow Fever Virus Vaccine Stamaril® in Korea

Conditions
-----------------
Yellow Fever

Intervention / Treatment
-----------------
* Biological: Stamaril®


Participation Criteria
=================
Eligibility Criteria
-----------------
Vaccination with Stamaril® vaccine in routine practice in Korea
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Stamaril®|Routine vaccination with Stamaril yellow fever vaccine|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants reporting suspected related adverse events | Spontaneous reporting of suspected related adverse events | Within 30 days after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants reporting suspected serious related adverse events | Spontaneous reporting of serious suspected related adverse events | Within 30 days after vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Yellow fever, Stamaril®
Prospective Study of 2 mm Margins for the Biopsy of Dysplastic Nevi

Study Overview
=================
Brief Summary
-----------------
Non-interventional study to evaluate the utility of removing Dysplastic Nevi with a defined 2 mm margin.

Detailed Description
-----------------
This is a prospective, observational study to evaluate the utility of removing Dysplastic Nevi (DN) with a defined 2 mm margin. This is a non-interventional study that will observe the pathology results following a standard of care biopsy. Principal Investigator (PI) hypothesize that the majority of lesions removed with this technique will have margins free of nevus cells on examination of histopathological sections. Hence, pathologists will not suggest that an additional excision be performed to remove any residual nevus. PI also hypothesize that if biopsy sites are followed over time, the rate of nevus recurrence will be low, because investigators would have removed the majority, if not all of the lesion at the time of initial biopsy.

Official Title
-----------------
Prospective Study of 2 mm Margins for the Biopsy of Dysplastic Nevi

Conditions
-----------------
Dysplastic Nevi

Intervention / Treatment
-----------------
* Procedure: Saucerization biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patents seen in the practices of the study physicians are eligible to participate in the study. Patients must be over 18 years of age. Patients who are able to provide informed consent. Patient must have a lesion in which the differential diagnosis includes a DN and for which the study dermatologist deems it is appropriate to perform a saucerization biopsy. Exclusion Criteria: Patients who are less than 18 years of age. Patients who are unable to provide informed consent. Lesions for which a saucerization biopsy is impractical in the judgment of the study dermatologist based on certain clinical factors (e.g. patient on anticoagulation therapy, lesion size and/or anatomic location).

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

| Intervention/Treatment |
| --- |
|Procedure: Saucerization biopsy|2 mm saucerization biopsy of dysplastic nevi|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clear margins on the histopathological sections examined after a 2 mm saucerazation biopsy. | 2 mm saucerization biopsy | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nevus recurrence rate | To determine the rate of nevus recurrence within 1 year of follow-up | Up to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Melanocytic neoplasm, Biopsy, Saucerization biopsy, Skin lesion
A Multivariate Index Assay for Ovarian Cancer Risk Assessment in Women With Adnexal Mass and High-Risk Germline Variants

Study Overview
=================
Brief Summary
-----------------
The objective of this project is to validate the sensitivity, specificity, positive predictive value and negative predictive values of the AMRA blood test for assessing risk of cancer in women at high risk for ovarian cancer, due to the presence of a symptomatic adnexal mass.

Official Title
-----------------
A Multivariate Index Assay for Ovarian Cancer Risk Assessment in Women With Adnexal Mass and High-Risk Germline Variants

Conditions
-----------------
Adnexal Mass

Intervention / Treatment
-----------------
* Device: OVAnex


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patient, 18 years of age or older diagnosed with an ovarian adnexal mass, or in follow-up due to the presence of BRCA1/2 and other germline DNA variants. Patient reviewed, understood, and provided the PI with written informed consent to allow blood specimen to be used for research and release of medical information. Exclusion Criteria: Patient is less than 18 years of age Patient is not being treated in the U.S.

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 |
| --- | --- |
| Group A<br>Symptomatic with adnexal mass | Device: OVAnex<br>* OVAnex is a multivarite index assay assessing ovarian cancer risk<br>|
| Group B<br>Asymptomatic with adnexal mass | Device: OVAnex<br>* OVAnex is a multivarite index assay assessing ovarian cancer risk<br>|
| Group C<br>Women with a predisposition in developing ovarian cancer due to a positive, pathogenic variant | Device: OVAnex<br>* OVAnex is a multivarite index assay assessing ovarian cancer risk<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OVAnex | OVAnex is a multivariate index assay assessing ovarian cancer risk. The Ovanex MIA uses seven biomarkers with a stepwise algorithm to generate a risk score which ranges from 0 to 20. | 12 months |
Effect of Shorten Gonadotropin-releasing Hormone Agonist Therapy on the Outcome of in Vitro Fertilization-Embryo Transfer in Patients With Endometriosis

Study Overview
=================
Brief Summary
-----------------
Gonadotropin-releasing hormone analogue (GnRH-a) is a synthetic decapeptide compound which can down-regulate pituitary function causing a temporary low estrogen state. Since endometriosis is an estrogen-dependent disease, the use of long-acting GnRH-a can control the growth of endometriosis by inhibiting ovary function.Some scholars have found that, for adenomyosis patients who received a super long protocol (pretreatment of long-acting GnRH-a for 1-2 months) in IVF treatment, the pregnancy outcome is comparable to that of the controls with normal uterus. Thus, the aim of this study is to compare the clinical pregnancy rate in patients treated with GnRH-a for 1, or 2 months.

Conditions
-----------------
Clinical Pregnancy Rate

Intervention / Treatment
-----------------
* Drug: Long term GnRH-a (3.75mg)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: first IVF cycle; with normal ovarian reserve(FSH(10miu/ml； antral follicle count )3) with normal uterine Exclusion Criteria: Pre-implantation genetic diagnosis cycles; Oocyte donation cycles

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 42 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Long term GnRH-a for 1 month<br>patient in this group only receive GnRH-a 3.75 for 1 month | Drug: Long term GnRH-a (3.75mg)<br>* patient in this group only receive GnRH-a 3.75 for pituitary down-regulation<br>|
| Experimental: patient in this group only receive GnRH-a 3.75 for 2 month<br>patient in this group only receive GnRH-a 3.75 for 2 month | Drug: Long term GnRH-a (3.75mg)<br>* patient in this group only receive GnRH-a 3.75 for pituitary down-regulation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy rate |  | 5 weeks after embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of oocytes retrieved |  | 1 day at oocyte retrieved day | 
| 2 pronucleus(2PN)fertilization rate | Number of 2PN/Matured oocytes | 48hours after oocyte retrieved day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
long term GnRH-a, endometriosis
Validation of Simplified Electrophysiological Examination in the Diagnosis of Critical Illness Myopathy or Neuropathy

Study Overview
=================
Brief Summary
-----------------
Evaluate the accuracy, in the diagnosis of critical illness myopathy and / or neuropathy, of the simplified peroneal nerve test performed by a neurophysiopathology technician or by a neurophysiopathology doctor (as the gold standard) compared to the exam performed by an intensivist.

Official Title
-----------------
Validation Study of Simplified Electrophysiological Examination in the Diagnosis of Critical Illness Myopathy or Neuropathy

Conditions
-----------------
Critical Illness Polyneuropathy, Critical Illness Myopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - adult patients admitted to Intensive care unit Exclusion Criteria: patients in terminal conditions patients with peroneal nerve exam not feasible ( for example with presence of prostheses, wounds, plaster casts, edema of the limbs)

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitivity and specificity of peroneal nerve test performed by a neurophysiopathologist compared to peroneal nerve test performed by an intensivist when peroneal nerve test is dichotomised in normal or abnormal | DTComPair-package in R | up to the comlpete execution of the two peroneal nerve exams,at most an hour | 
| specificity of peroneal nerve test performed by a neurophysiopathologist compared to peroneal nerve test performed by an intensivist when peroneal nerve test is dichotomised in normal or abnormal | DTComPair-package in R | up to the comlpete execution of the two peroneal nerve exams, at most an hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of concordance between peroneal nerve test performed by an intensivist compared to peroneal nerve test performed by a neurophysiopathologist considering the test as a continuous variable | It will be performed either using Bland-Altman plot and mix model effect | up to the comlpete execution of the two peroneal nerve exams, at most an hour | 
| correlation between hospital mortality and abnormal peroneal nerve test | Anova | up to hospital discharge, an average of 6 months | 
| correlation between hospital discharge destination and abnormal peroneal nerve test | Anova | up to hospital discharge, an average of 6 months |
Treatment Use Study for Advanced Melanoma.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to provide access to CP-675,206 for patients with advanced unresectable melanoma and who have the potential to gain benefit from this treatment and who are not eligible for participation in other CP-675,206 studies.

Detailed Description
-----------------
This is an expanded access trial that canceled prior to enrolling patients.

Official Title
-----------------
Treatment Use Study of CP-675,206 for Advanced Melanoma

Conditions
-----------------
Advanced Unresectable Melanoma

Intervention / Treatment
-----------------
* Drug: CP-675,206


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced melanoma with life expectancy of at least 6 months. Melanoma must be considered unresectable. Patients with stable, treated brain mets must be stable clinically and radiographically and off steroids for at least one month. Exclusion Criteria: Patients must not be eligible for participation in any ongoing CP-675,206 clinical studies currently open for enrollment. History of chronic inflammatory or autoimmune disease. History of inflammatory bowel disease, celiac disease, or other chronic gastrointestinal conditions associated with diarrhea, active colitis, history of diverticulitis.

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

| Intervention/Treatment |
| --- |
|Drug: CP-675,206|This is a single arm study. Patients will receive intravenous administration of CP-675,206 at a dose of 15 mg/kg on Day 1 of every 90-day cycle for up to 4 cycles. For purposes of treatment visits and scheduling, each cycle is defined as a 90 (± 4 day) period. Patients who discontinue treatment after 4 doses of CP-675,206 without disease progression and who subsequently experience disease progression more than 3 months after the last dose may receive 2 additional doses of CP-675,206 provided that they have not received other systemic therapy for their melanoma Survival in this study will be monitored on all patients for up to 5 years from the date of first dose of CP-675,206.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effects of OM-174 in Adult Patients With Solid Tumors

Study Overview
=================
Brief Summary
-----------------
Methods Patients received OM-174 twice weekly for a total of 5, 10 or 15 injections of either 600, 800 or 1000 µg/m². Pharmacokinetic analysis and cytokine dosages were performed. Natural Killer cells activity and toll-like receptors 4 polymorphism analysis were also performed.

Official Title
-----------------
Phase One Study With Direct Individual Benefit: Effects of OM-174 in Adult Patients With Solid Tumors.

Conditions
-----------------
Solid Tumors

Intervention / Treatment
-----------------
* Biological: Injections of OM-174


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with a histologically proven solid tumor, refractory to conventional treatment or for which no such treatment existed. At least one month since the last chemotherapy Life expectancy above 3 months Written informed consent Age above 18 Exclusion Criteria: Patient's refusal Infection Brain metastasis Autoimmune disease Regular use of steroids Patient included in another protocol Chemotherapy or radiotherapy less than 6 weeks ago Immunotherapy less than 8 weeks ago

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

Allocation: Non-Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Injections of OM-174|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The occurrence of any adverse event |  | up to 8 weeks |
Endovascular treatmenT for Acute Ischemic Stroke in China (DETECT2-China)

Study Overview
=================
Brief Summary
-----------------
This is a prospective real world registry study, aiming to explore the effectiveness and safety of endovascular treatment of acute ischemic stroke in a Chinese population.

Official Title
-----------------
enDovascular trEatmenT for acutE isChemic sTroke in China (DETECT2-China): a Prospective, National, Multi-center, Registry Study

Conditions
-----------------
Stroke, Ischemic

Intervention / Treatment
-----------------
* Device: endovascular treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: ≥ 18; Ischemic stroke confirmed by head CT or MRI; Patients receiving endovascular treatment; First ever stroke or pre-stroke mRS≤2; signed informed consent. Exclusion Criteria: Prestroke mRS≥3; Other serious illness that would confound the clinical outcome at 90 days; Unavailable neuroimaging data; Other unsuitable conditions judged by the investigator

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: endovascular treatment|all enrolled patients must receive endovascular treatment|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with modified Rankin Score 0 to 2 | the minimum and maximum values of modified Rankin Score are 0 and 6, respectively; higher score mean a worse outcome | Day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with modified Rankin Score 0 to 1 | the minimum and maximum values of modified Rankin Score are 0 and 6, respectively; higher score mean a worse outcome | Day 90 | 
| Distribution of modified Rankin Score | the minimum and maximum values of modified Rankin Score are 0 and 6, respectively; higher score mean a worse outcome | Day 90 | 
| Changes in National Institute of Health stroke scale (NIHSS) | the minimum and maximum values of NIHSS are 0 and 24, respectively; higher NIHSS mean a worse outcome | 24 hours, 48 hours, and 2 weeks | 
| Proportion of symptomatic intracranial hemorrhage (sICH) | sICH was defined as 4 or more increase in NIHSS caused by hemorrhage | 48 hours | 
| Proportion of death | death due to any cause | 7 days |
Pilot Study Testing Feasibility of Health Screening at Farm Site

Study Overview
=================
Brief Summary
-----------------
Test the feasibility of performing worksite screening of Hypertension, Diabetes and Hyperlipidemia for six months

Detailed Description
-----------------
The investigators will be visiting farmers at the worksite monthly for six month and perform cardiovascular risk factors screening: blood pressure, blood glucose, glycosylated hemoglobin and cholesterol. At the end of this intervention, the investigators will test the feasibility of this approach among this specific population through questionnaires.

Official Title
-----------------
Worksite Screening for Cardiovascular Risk Factors Among Migrant Agricultural Workers

Conditions
-----------------
Diabetes Screening, Hyperlipidemia Screening, Hypertension Screening

Intervention / Treatment
-----------------
* Other: Worksite screening for DM, HTN and hyperlipidemia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years and older agricultural workers and farm owners 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Farm workers<br>This is a one arm intervention including farm workers and owners | Other: Worksite screening for DM, HTN and hyperlipidemia<br>* Six monthly visits to worksite to perform screenings<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility (Likert scale) | On a likert scale, the investigators will test the applicability, acceptance and convenience of this screening approach among this agricultural workers population | After six months of the intervention, the outcome will be assessed on the last site visit via questionnaire | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
worksite, screen, migrant, agricultural, worker, hypertension, Hyperlipidemia, diabetes, feasibility