linjc16/ctgov huggingface dataset:
Prevalence of BRCA in Patients With Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
The aim of this prospective registration and translational research study is to evaluate the praevalence of BRCA regarding germline and somatic mutations.

Detailed Description
-----------------
Explorative analysis will be performed.

Official Title
-----------------
Prevalence of BRCA in Patients With Primary or Platinum Sensitive Recurrent Ovarian Cancer.

Conditions
-----------------
BRCA Status, Ovarian Cancer

Intervention / Treatment
-----------------
* Genetic: Testing of BRCA status regarding germline and somatic mutation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female ovarian cancer patients aged >= 18 years. Women with first diagnosis of epithelial ovarian cancer OR women diagnosed with platinum-sensitive recurrent ovarian cancer. Multiple platinum based prior therapies are allowed. Exclusion Criteria: Non-epithelial ovarian malignancy. Platinum-resistant or refractory disease. Paraffin embedded tumor samples not available.

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 |
| --- | --- |
| patients with primary diagnosis<br>patients with primary diagnosis of ovarian cancer for testing of BRCA status regarding germline and somatic mutation | Genetic: Testing of BRCA status regarding germline and somatic mutation<br> <br> |
| patients with platinum-sensitive recurrence<br>patients with platinum-sensitive recurrence of ovarian cancer for testing of BRCA status regarding germline and somatic mutation | Genetic: Testing of BRCA status regarding germline and somatic mutation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Germline alterations in BRCA1/2 (yes/no) and other ovarian cancer predisposing genes (yes/no; if yes which) |  | once per sample | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Results of Immunohistochemistry in tumor samples |  | once per sample | 
| Somatic alterations in BRCA1/2 (yes/no) and other ovarian cancer predisposing genes (yes/no; if yes which) |  | once per sample | 
| BRCAness tumor phenotype in ovarian cancer (yes/no). |  | once per sample | 
| Differences of tumor samples from primary and relapsed disease |  | once per sample for each stage of disease | 
| Patient Survey for perspectives and satisfaction regarding testing and counseling | 3 questions | once after BRCA result is available | 
| Determining the correlation of genetic alterations, cancer treatments, overall survival, progression-free survival and occurrence of new malignancies |  | once |
A Study to Evaluate the Effectiveness and Safety of RXI-109 on the Outcome of Keloid Excision Surgery in Healthy Adults

Study Overview
=================
Brief Summary
-----------------
To evaluate the effectiveness of RXI-109 in reducing the recurrence of keloid formation following elective keloid excision.

Official Title
-----------------
A Multi-Center, Prospective, Randomized, Single-Blind, Within-Subject Controlled, Phase 2a Study to Evaluate the Effectiveness and Safety of RXI-109 on the Outcome of Keloid Excision Surgery in Healthy Adults

Conditions
-----------------
Keloid

Intervention / Treatment
-----------------
* Drug: RXI-109
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults, 21-55 years of age. Two keloids of approximately similar size and anatomical location on the earlobe, neck, or torso. Keloids to be excised must have been present for > 1 year. Exclusion Criteria: Use of tobacco or nicotine-containing products Pregnant or lactating Post-menopausal or full hysterectomy

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Treatment with RXI-109 at the site of one excised keloid and a placebo at the site of a second excised keloid. Dosing to begin at the time of surgery. | Drug: RXI-109<br> <br> Drug: Placebo<br> <br> |
| Experimental: Cohort 2<br>Treatment with RXI-109 at the site of one excised keloid and a placebo at the site of a second excised keloid. Dosing to begin two weeks after surgery. | Drug: RXI-109<br> <br> Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in the recurrence of a keloid after keloid excision | To evaluate the effectiveness of RXI-109 in reducing the recurrence of keloid formation following elective keloid excision | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of RXI-109 | To assess severity and frequency of reported adverse events and clinically-relevant changes in laboratory testing after elective excision of a keloid | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Keloid, Cicatrix, Keloid prevention, Keloid revision/excision, Keloidectomy
An Observational Study of Avastin (Bevacizumab) in Combination With Chemotherapy as First-Line Treatment in Patients With Advanced Ovarian Cancer (OSCAR 1)

Study Overview
=================
Brief Summary
-----------------
This multicenter, prospective, observational study will evaluate the safety and efficacy of Avastin (bevacizumab) in combination with chemotherapy as first-line treatment in patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer in routine clinical practice. Eligible patients will be followed for approximately 15 months.

Official Title
-----------------
AN OBSERVATIONAL STUDY OF AVASTIN® (BEVACIZUMAB) AS FIRST LINE THERAPY IN PATIENTS WITH ADVANCED OVARIAN CANCER

Conditions
-----------------
Ovarian Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 18 years of age Advanced (FIGO stages IIIB, IIIC and IV) epithelial ovarian, fallopian tube or primary peritoneal cancer not previously treated with chemotherapy Initiating Avastin in combination with chemotherapy Exclusion Criteria: Contraindications, warnings and precautions for use as specified in the Avastin Summary of Product Characteristics

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival, defined as time from first administration of first-line therapy to documented disease progression |  | approximately 6 years | 
| Safety: Incidence of adverse events |  | approximately 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival, defined as time from first administration of first-line therapy to documented death |  | approximately 6 years | 
| Objective response rate, defined as percentage of patients with complete or partial response according to local assessments |  | approximately 6 years | 
| Quality of life: EQ-5D/EORTC questionnaires |  | approximately 6 years | 
| Dosage/schedule/duration of Avastin therapy |  | approximately 6 years | 
| Composition of first-line chemotherapy regimens: drugs/dosage/duration |  | approximately 6 years |
Sculptra Chart Review

Study Overview
=================
Brief Summary
-----------------
Multi-center retrospective chart review to evaluate the safety of Sculptra Aesthetic when used in non-facial areas

Official Title
-----------------
A Multi-center Retrospective Chart Review to Evaluate the Safety of Sculptra Aesthetic When Used in Non-facial Areas

Conditions
-----------------
Non-facial Skin Aesthetic Conditions

Intervention / Treatment
-----------------
* Device: Sculptra Aesthetic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who have been treated at the site with Sculptra Aesthetic in non-facial areas Subjects with available information about treatment dates and treatment procedures Exclusion Criteria: Subject that have actively asked not to be involved in a study or registry Other conditions that in the Investigator's opinion would exclude the subject from participation ; the condition should be recorded.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Females/Males treated with Sculptra Aesthetic in non-facial areas<br>Sculptra Aesthetic administration in non-facial areas | Device: Sculptra Aesthetic<br>* Sculptra Aesthetic in non-facial areas<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate safety of Sculptra Aesthetic when used in non-facial areas | AEs related to the product or injection procedure reported in the medical chart | January 2018 to 2022 |
Incidence of Neo-Aortic Insufficiency

Study Overview
=================
Brief Summary
-----------------
The records of all the patients that underwent the Norwood-Sano operation at Children's Healthcare of Atlanta, Emory University between January 1, 2002 and December 31, 2004 will be investigated. These patients will be compared with an equal number of consecutive cases treated by classic Norwood stage I operation in order to determine the incidence of neo-aortic valve insufficiency and the clinical outcome of these patients.

Detailed Description
-----------------
Neoaortic valve insufficiency after Norwood type palliation of single ventricle patients has not been well studied. Patients with mild insufficiency tolerate it well; moderate to severe insufficiency however is poorly tolerated and can result in the death of the patient or at least require re-operation. Re-operation for neo-aortic insufficiency in this small size child is a difficult operation and the operative options are very limited. The introduction of the Sano modification of the Norwood procedure introduced a new set of variables due to the presence of a ventricular incision and possible distortion of the neo-aortic valve. It is therefore critical to determine the incidence of neo-aortic insufficiency and compare it to the standard Norwood operation, as well as to determine the clinical consequences of the presence of this phenomenon immediately postoperatively as well as long-term, up to completion of the stage II of the Norwood procedure (Glenn stage).

Official Title
-----------------
Comparison of the Incidence of Neo-Aortic Insufficiency After Classic Norwood I and Norwood I-Sano Procedures

Conditions
-----------------
Congenital Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergone Norwood-Sano at Children's Healthcare of Atlanta between 9.2.2002 and 12.31.2004 equal number of consecutive patients undergone Norwood classic stage I at Children's Healthcare of Atlanta between 9.2.2002 and 12.31.2004 Exclusion Criteria: those who do not meet the inclusion criteria

Ages Eligible for Study
-----------------
Maximum Age: 21 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
-----------------
Pediatric, cardiac, neo-aortic insufficience, Norwood standard Stage I procedure, Norwood Sano procedure
Long-Term Compassionate Use Study for Continued Administration of SCB01A-01

Study Overview
=================
Brief Summary
-----------------
The primary objective is to characterize the safety profile of long-term exposure to SCB01A when administered to cancer subjects with advanced solid tumors. Furthermore, the efficacy profile will also be explored in this study.

Detailed Description
-----------------
This is a companion study to the protocol SCB01A-01 intended to provide long-term continued administration to subjects that completed Protocol SCB01A-01 on a compassionate basis. It is an open-label, single-arm study of SCB01A in subjects who have completed at least one cycles of treatment under the SCB01A-01 protocol.

Official Title
-----------------
Long-Term Compassionate Use Study for Continued Administration of SCB01A In Subjects Who Completed Treatment With SCB01A in the Previous Protocol # SCB01A-01

Conditions
-----------------
Malignant Solid Tumour

Intervention / Treatment
-----------------
* Drug: SCB01A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who completed protocol SCB01A-01 and exhibited a favorable response or had no clinical evidence of disease progression (i.e. stable disease, partial response or complete response). Exclusion Criteria: Study participants meeting any of the following criteria will be excluded from enrollment: Unwilling or unable to provide informed consent. Unwilling or unable to comply with the requirements of the protocol. Has unresolved toxicities from previous SCB01A-01 protocol.

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: SCB01A|This is a companion study to the protocol SCB01A-01 intended to provide long-term continued administration to subjects that completed Protocol SCB01A-01 on a compassionate basis. It is an open-label, single-arm study of SCB01A in subjects who have completed 2 cycles of treatment under the SCB01A-01 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
-----------------
Advanced solid tumor failed with standard therapy
Prospective Randomized Comparison of Cold Snare Polypectomy and Conventional Polypectomy

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare cold snare polypectomy and conventional polypectomy for the removal and retrieval of small colorectal polyps. Cold snare polypectomy for colorectal polyps up to 8 mm is expected to be more effective than conventional polypectomy.

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

Intervention / Treatment
-----------------
* Procedure: cold polypectomy
* Procedure: conventional polypectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Men or women between 20 and 100 years of age Exclusion Criteria: Exclusion criteria include age less than 20 years old Pregnant, American Society of Anesthesiologists class III and IV Overweight (body weight > 100 kg) Allergic to the drugs used or its components (soybeans or eggs) Poor bowel preparation or post-colorectal surgery.

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Procedure: cold polypectomy<br>* The removal of small colorectal polyps up to 8 mm is performed using cold snare polypectomy.<br>* Other names: cold snare polypectomy;|
| Active Comparator: 2<br> | Procedure: conventional polypectomy<br>* The removal of small colorectal polyps up to 8 mm is performed using conventional polypectomy.<br>* Other names: polypectomy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete removal rate of colorectal polyps |  | two weeks after each polypectomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate |  | two weeks after each polypectomy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
polypectomy, colonic polyp, colorectal polyp, colorectal cancer prevention
Cell-free Tumor DNA as Minimal Residual Disease in Hodgkin Lymphoma Patients

Study Overview
=================
Brief Summary
-----------------
Molecular analysis identifies residual disease by overcoming the sensitivity of imaging methods and therefore has the potential for integrating with therapy provided by FDG-PET alone. It is a well known fact that tumor DNA circulating in plasma (ctDNA) reflects the mutational profile of tumor cells and can be used to non-invasively detect specific mutations of Hodgkin's lymphoma without the need for microdissecting the histological sample.

Detailed Description
-----------------
A clinical need, not yet met for the Hodgkin lymphoma disease, brings about the early and accurate identification of chemo-refractory patients who require stepping up of treatment as also, patients with good prognosis receiving treatment de-escalation.Molecular methods identify residual disease by overcoming the sensitivity of imaging methods and therefore have the potential to integrate the response to therapy provided by FDG-PET alone. ctDNA modification from the basal time point to the interim can be used as a predictor of response to the ABVD scheme and as a complement to the interim-PET in the possible variation of the therapeutic schedule. Clinical data and peripheral blood samples (20 ml in EDTA tubes and 20 ml in Cell-Free DNA BCT tubes) will be collected during the clinico/laboratory visits that are planned as per clinical routine at the time of diagnosis, at each cycle of chemotherapy, at the time of interim PET/CT, at the time of end of treatment PET/CT and during follow up.

Official Title
-----------------
Cell-free Tumor DNA Analysis for Minimal Residual Disease Detection in Patients With Hodgkin Lymphoma

Conditions
-----------------
Hodgkin Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female adults 18 years or older Documented diagnosis of Hodgkin lymphoma (both classic and nodular predominant lymphocytes subtype) according to 2016 WHO classification Willing and able to comply with scheduled study procedures Evidence of a signed informed consent ECOG performance status 0-2 (or 3, if disease related)

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of interim ctDNA genotyping | Sensitivity of interim ctDNA genotyping in identifying chemorefractory patients or patients with good prognosis (patients who do not progress after 24 months) | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ctDNA, Next generation sequencing, Hodgkin lymphoma
Variability of Infant LP Insertion Site Based On Procedural Experience

Study Overview
=================
Brief Summary
-----------------
The reported rate of unsuccessful traditional LP in children (defined as the inability to obtain cerebrospinal fluid or obtaining a traumatic puncture) is as high as 50%. Many factors affect LP success including provider experience. CSF is obtained by puncturing the subarachnoid space (traditionally at the L3-L4 or L4-L5 interspinous process space), and many have hypothesized that the width of this space may predict success. Anecdotally, trainees and those with less experience, tend to perform the LP too low (caudally), where the subarachnoid space tapers, or too laterally (off the midline) resulting in higher failure rates. The investigators seek to determine if planned LP insertion sites vary between training and attendings, and if so, could the decreased success be explained by smaller subarachnoid spaces.

Official Title
-----------------
Variability of Infant LP Insertion Site Based On Procedural Experience

Conditions
-----------------
Traumatic Lumbar Puncture

Intervention / Treatment
-----------------
* Other: Spinal Sonography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Less than or equal to 12 months of age Availability of a study sonographer to perform bedside ultrasound Exclusion Criteria: Prior history of LP in preceding 72 hours Known spinal cord abnormality (i.e., tethered cord, spina bifida) Clinically unstable patients (acuity level 1)

Ages Eligible for Study
-----------------
Maximum Age: 12 Months

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

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

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 |
| --- | --- |
| Experimental: Infant Lumbar Punctures<br>Infants will all be assigned to received two sets of skin markings and sonography exam to assess lumbar puncture landmarks and anatomy. | Other: Spinal Sonography<br>* As described previously<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Trainee & Attending LP Insertion Sites that are the same | Plan to visualize marked spaces with US to delineate if the trainee and attending marked the same or different interspace (we will quanity the proportion of same interspaces marked and for those that are different, we will quantify the proportion above or below the attending marking) | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subarachnoid Space Width | Measure subarachnoid space width (mm) | 18 months | 
| Subarachnoid Space Area | Measure subarachnoid space area (mm2) | 18 months |