linjc16/ctgov huggingface dataset:
Metastatic Breast Cancer in Brazil: Characterization of Patients and Treatments

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe demographics and socioeconomics characteristics associated to the diagnosis of metastatic breast cancer in Brazil.

Detailed Description
-----------------
The primary aim of this study is to characterize patients and treatments of metastatic breast cancer in Brazil. Other specific aims are: to describe patients demographics and socioeconomic characteristics to describe the BC pathological characterization to describe treatment (describe each treatment with dates start-end, cycles, dosing, sequence and line of treatment, reason for discontinuation) to analyze patients outcome (time to progression, site of metastasis, progression free survival (PFS), overall survival (OS), skeletal related events (SRE))

Official Title
-----------------
Metastatic Breast Cancer in Brazil: Characterization of Patients and Treatments

Conditions
-----------------
Metastatic Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women > 18 years old Patients diagnosed with de novo or recurrent metastatic breast cancer during the period of January to December 2012 Any invasive breast cancer histology and subtype Exclusion Criteria: Male breast cancer

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

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

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 |
| --- | --- | --- |
| Description of sociodemographic and socioeconomics characteristics associated to diagnostic and treatment of metastatic breast cancer in Brazil |  | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of demographic characteristics of metastatic breast cancer patients |  | 8 months | 
| The clinical and pathological characteristics of patients with metastatic breast cancer |  | 8 months | 
| Prior treatment for breast cancer before metastatic disease |  | 8 months | 
| The description of the clinical outcome of the patient diagnosed with metastatic breast cancer |  | 8 months | 
| Type of treatment after the diagnosis of metastatic breast cancer |  | 8 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast cancer, Metastasis
Animated Video Consultation for Reducing Pre-Operative Anxiety in Outpatient Dermatologic Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate whether the addition of an animated skin surgery educational video to conventional in-person surgery consultation will help reduce pre-operative anxiety in patients awaiting outpatient skin surgery.

Detailed Description
-----------------
This will be an randomized controlled pilot study. Subjects will be randomized to either receive an animated video along with conventional consultation OR receive a conventional consultation only. Pre-operative anxiety will be assessed.

Official Title
-----------------
Animated Video Consultation for Reducing Pre-Operative Anxiety in Outpatient Dermatologic Surgery

Conditions
-----------------
Dermatology/Skin - Other

Intervention / Treatment
-----------------
* Other: VC Group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female, at least 18 years of age Subjects scheduled to undergo outpatient skin surgery Subjects able to comprehend and read the English language. Exclusion Criteria: Subjects unable to or unwilling to comply with the study procedures Subjects unable to speak or read the English language.

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: VC (Conventional Consultation/Video) Group<br>Subjects will receive conventional consultation and watch an animated video. | Other: VC Group<br>* VC (Conventional Consultation/Video) Group<br>|
| No Intervention: CC (Conventional Consultation) Group<br>Subjects will receive conventional consultation only. Subjects will cross-over to receive animated video at the end. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-operative anxiety levels assessed via questionnaire | Preoperative anxiety and information scale will be collected. | 1 day |
Monoclonal Antibody Therapy in Treating Children With Metastatic Neuroblastoma in Second Remission

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody in treating children with metastatic neuroblastoma in second remission.

Detailed Description
-----------------
OBJECTIVES: I. Evaluate the efficacy of ganglioside GD2-specific monoclonal antibody 3F8 as adjuvant therapy in patients with Stage IV neuroblastoma in second remission. OUTLINE: Biological Response Modifier Therapy. Antiganglioside GD2-specific Monoclonal Antibody 3F8, MOAB 3F8. PROJECTED ACCRUAL: A maximum of 20 patients will be entered.

Official Title
-----------------
Phase II Study of Adjuvant Therapy With Antiganglioside GD2-Specific Mouse Monoclonal Antibody 3F8 for Metastatic Neuroblastoma in Second Remission

Conditions
-----------------
Neuroblastoma

Intervention / Treatment
-----------------
* Biological: monoclonal antibody 3F8


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically confirmed, Stage IV neuroblastoma in second or subsequent complete remission, defined by the complete disappearance of all evidence of tumor on the following: Physical examination Second-look surgery Bone scan Bone marrow aspiration and biopsy Chest x-ray CT MIBG Urinary catecholamines If marrow is infiltrated by tumor, complete elimination of tumor cells from the marrow compartment must be demonstrated by histology and immunofluorescence (based on simultaneous bone marrow aspiration and biopsy samples from at least 4 separate sites) PATIENT CHARACTERISTICS: Age: Under 18 Performance status: Not specified Life expectancy: Greater than 12 weeks Hematopoietic: Grade 4 cytopenias allowed Grade 3 marrow hypoplasia allowed Hepatic: Not specified Renal: No renal dysfunction worse than grade 3 Cardiovascular: No cardiac dysfunction worse than grade 2 Pulmonary: No pulmonary dysfunction worse than grade 2 Other: No neurologic dysfunction worse than grade 2 Hearing deficit allowed PRIOR CONCURRENT THERAPY: Prior murine antibody therapy allowed provided circulating HAMA titer is less than 1,000 U/mL serum by ELISA

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

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: monoclonal antibody 3F8|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
-----------------
disseminated neuroblastoma, recurrent neuroblastoma
Oral Estradiol Valerate Versus Oral Contraceptive Pill in Invitro Fertilization Patients

Study Overview
=================
Brief Summary
-----------------
The recent controversy regarding the use of pill for cycle planning in GnRH antagonists IVF cycle has driven the search for new ways to plan IVF cycles in order to avoid weekends or to equally distribute the workload. Recently, mid-late luteal phase oral estrogens seem to be as good as the pill. The investigators will compare OCP vs oral estrogens to plan the initiation of IVF cycles.

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: Levonorgestrel and ethinylestradiol
* Drug: Estradiol valerate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1st or 2nd IVF cycle BMI <30 kg/m2 regular menstrual cycles basal FSH <10IU and E2 <60pg/mL Exclusion Criteria: polycystic ovaries endometriosis previous ovarian surgery previous low ovarian response

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 38 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: OCP<br> | Drug: Levonorgestrel and ethinylestradiol<br>* 30 microgram of ethinylestradiol plus levonorgestrel daily for 12 to 16 days<br>|
| Active Comparator: Oral estradiol valerate<br> | Drug: Estradiol valerate<br>* 4mg estradiol valerate from cycle day 20 till the day before the initiation of the cycle<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation rate | number of embryonic sacs visible by ultrasound divided by the number of embryos transferred | 20 days after the embryo transfer |
One Year Outcome After Robotic Assisted Laparoscopic Sacral Colpopexy, a Case Series Review

Study Overview
=================
Brief Summary
-----------------
Robotic approach to sacral colpopexy is a relatively new procedure. The literature is scarce in regard to its long-term outcomes. This advanced procedure is offered at MMH through the Urogynecology division. The Investigators setup to review the one year outcome of patients who underwent this procedure using a polypropylene mesh. These outcomes will include anatomical and quality of life measures.

Official Title
-----------------
One Year Outcome After Robotic Assisted Laparoscopic Sacral Colpopexy, a Case Series Review

Conditions
-----------------
Pelvic Organ Prolapse, Urinary Incontinence

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any Robotic assisted laparoscopic sacral colpopexy with polypropylene mesh during the study period Exclusion Criteria: Other graft material than polypropylene. Enrollment in a different study.

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| Robotic sacral colpopexy<br>Our study population will be women who underwent Robotic assisted laparoscopic sacral colpopexy at the Morristown Memorial Hospital for correction of pelvic organ prolapse using a synthetic polypropylene mesh. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Objective anatomic outcomes We will use the pelvic organ prolapse quantification system (POP-Q). Objective surgical failure will be defined as any prolapse at or beyond the introitus |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2. Prolapse Specific Quality of Life Patients will complete a prolapse specific quality of life instrument prior to and one year after surgery. (PFIQ-7) |  | one year | 
| 3. Pelvic organ prolapse related symptoms (PFDI-20) |  | one year | 
| 4. Graft-related complications Rates of graft erosion into adjacent organs such as bowel, bladder or vagina - during the study period will be reported. |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
uterine Prolapse, vaginal prolapse, mesh erosion, urinary incontinence, bowel symptoms
Role of PTK-7 in Acute Myeloid Leukemias

Study Overview
=================
Brief Summary
-----------------
The pseudo tyrosine kinase receptor 7 (PTK7) is an orphan tyrosine kinase receptor assigned to the planar cell polarity pathway. PTK7 is expressed in normal myeloid progenitors and CD34(+) CD38(-) bone marrow cells in humans. It is also expressed in acute myeloid leukemia (AML) and is mostly assigned to granulocytic lineage differentiation. In AML, PTK7 seems to convey promigratory and antiapoptotic signals into the cell and represents an independent prognosis factor of survival in patients treated with induction chemotherapy. This study aims at: evaluating the impact of PTK7 expression on primary AML cells ex vivo evaluating the diagnostic and prognostic value of a soluble form of PTK7

Official Title
-----------------
Role of PTK-7 in Acute Myeloid Leukemias: Impact of PTK7 Serum Marker and ex Vivo Studies to Decipher the Role of PTK7

Conditions
-----------------
Acute Myeloid Leukemia

Intervention / Treatment
-----------------
* Other: Bone marrow aspiration
* Other: Blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age> 18 years AML at diagnosis, not previously treated Treatment by induction chemotherapy Signed informed consent Affiliation to the French social security system Exclusion Criteria: pregnant woman(or of childbearing potential) or breastfeeding woman emergency patients deprived of liberty or placed under the authority of a tutor

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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AML patients at diagnosis<br> | Other: Bone marrow aspiration<br> <br> Other: Blood sampling<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation PTK7+ and PTK7- AML cells hematopoietic homing abilities in xenografted mice by in vivo bioluminescence imaging |  | 1 day | 
| Soluble PTK7 measurement in the serum |  | 12 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PTK7, Acute Myeloid Leukemia
Markers of Oxidative Stress in a Early Week Miscarriage: Ischemia of Modified Albumin

Study Overview
=================
Brief Summary
-----------------
The finding that ischemia-modified albumin (IMA) is increased in pre-eclamptic pregnancy suggests a role for IMA as a potential biomarker for abnormal placental development related to miscarriage.This study was undertaken to evaluate IMA levels in women with recurrent pregnancy loss (RPL).

Detailed Description
-----------------
Ischemia-modified albumin (IMA) measured by the albumin cobalt binding test is a relatively new biomarker in the identification of myocardial ischemia. Experimental studies have shown that pregnancies normally develop in a relatively hypoxic intrauterine environment, and the subsequent reperfusion and oxidative stress is important for physiological trophoblast development. The finding that maternal serum IMA levels are raised so early in pregnancy provides further support for IMA as a potential marker for abnormal placental development that may be related to early pregnancy loss. In this study, we aimed to evaluate maternal circulating IMA levels in women with RPL by comparing them with healthy controls.

Official Title
-----------------
Markers of Oxidative Stress in a Early Week Miscarriage: Ischemia of Modified Albumin

Conditions
-----------------
First Trimester Pregnancy, Fetal Heart Activity Absent, Absence of Fetal Pole on Ultrasonographic Examination.

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: first trimester pregnancy absence of fetal cardiac activity absence of fetal pole history of two or more unexplained first trimester miscarriages no live births apparently healthy women attending for antenatal care in the first trimester with at least one previous uneventful natural pregnancy Exclusion Criteria: pre-existing diabetes or vascular disease were excluded diagnosis of chromosomal, anatomic, endocrinologic and autoimmunologic etiology of recurrent pregnancy loss Women with multiple pregnancy any major or minor fetal anomaly current smokers
Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- | --- |
| first trimester pregnant women | first trimester pregnancy with absence of fetal cardiac activity or absence of fetal pole on ultrasonographic examination Patients with a history of two or more unexplained first trimester miscarriages and no live births were included in the study. | under 14 w gestation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ischemia-modified albumin, Recurrent pregnancy loss, Abnormal placenta
ADenoVirus Initiative Study in Epidemiology in Germany

Study Overview
=================
Brief Summary
-----------------
The objectives of this study is to assess the characteristics and frequency of adenovirus conjunctivitis in a population of male and female patients from one year of age who present signs and symptoms of acute conjunctivitis.

Detailed Description
-----------------
Epidemiological, prospective, open, multicentric trial in patients suffering from acute conjunctivitis who will undergo a rapid diagnostic test for adenoviral conjunctivitis at the time of their visit to the ophthalmologist office, at the emergency room or during hospitalization. This epidemiological study will include approximately 500 patients in Germany. The planned duration of the study is one year from the first patient visit to the last patient visit.

Official Title
-----------------
Epidemiological, Prospective, Multicentric, Open Study To Assess The Characteristics And Frequency Of Adenoviral Conjunctivitis As Diagnosed With The Point Of Care AdenoPlus® Test In Patients Suffering From Acute Conjunctivitis

Conditions
-----------------
Viral Conjunctivitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female patients of at least one year of age presenting acute (for less than 7 days) conjunctivitis signs and symptoms. Patient or / and legal representative (if patient below 18 years of age) must be able to provide oral consent for the collection and treatment of the questionnaire data. No history of hypersensitivity to corn starch, talcum powder or Dacron (sampling fleece components). Exclusion Criteria: Current use or having received (within the last 7 days) local antiviral therapies such as povidone iodine or ganciclovir, or topical steroids or immunomodulators such as cyclosporine which may interfere with the test result. Previous enrolment in the present study. Any direct involvement with the study conduct at site or any family link with study site staff.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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 |
| --- | --- | --- |
| Frequency of patients with adenovirus conjunctivitis | The percentage of patients with adenovirus conjunctivitis documented by a positive AdenoPlus® test over the tested population of male and female patients who present signs and symptoms of acute conjunctivitis. | During the visit to the ophthalmologist before and just after the AdenoPlus® test done on the same day (one visit) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adenoviral conjunctivitis diagnosed with AdenoPlus™ Test