linjc16/ctgov huggingface dataset:
Safety of Herceptin/Trastuzumab in Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This study was designed to evaluate safety and tolerability of Herceptin as treatment for patients with human epidermal growth factor receptor 2 (HER-2) positive metastatic breast cancer. Frequency, characteristics and severity of adverse events (AE) and serious adverse events (SAE) were followed to evaluate the safety of Herceptin in patients with HER2 positive metastatic breast cancer.

Official Title
-----------------
Safety of Herceptin in Metastatic Breast Cancer

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

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of metastatic breast cancer (BC) with HER2-neu overexpression Left Ventricular Ejection Fraction (LVEF) by ECHO or Multi Gated Acquisition Scan (MUGA) > 50% Good performance status: Eastern Cooperative Oncology Group (ECOG) scale < or = 2 and life expectancy > or = 12 weeks Exclusion Criteria: Advanced pulmonary disease and severe dyspnea Abnormal laboratory within 14 days prior to registration Peripheral neuropathy > grade 2 Presence of central nervous system (CNS) metastasis Pregnancy or lactating

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 |
| --- | --- |
| HER 2 positive metastatic breast cancer<br>HER 2 positive metastatic breast cancer treated with Herceptin as per registered indication, until disease progression. | Other: No intervention<br>* No intervention administered in this study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Adverse Events (AEs) |  | Up to 2 years | 
| Percentage of Participants with Serious Adverse Events (SAEs) |  | Up to 2 years | 
| Percentage of Deaths |  | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Serious Adverse Events (SAEs), Who Experienced Progression of Disease |  | Up to 2 years |
Non-invasive Chromosomal Examination of Trisomy Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this blinded, multi-center, prospective, case-controlled study is to compare the Ariosa Harmony™ Prenatal Test for trisomy 21 detection with a standard first-trimester prenatal screening test consisting of serum screening (PAPP-A,free beta-hCG [β-hCG] or total hCG) and a nuchal translucency (NT) measurement (i.e. combined first trimester screening) in a general screened population. The performance characteristics of these two test modalities will be assessed relative to the clinical reference standard of genetic analysis of the fetus or phenotypic characterization and genetic analysis of the newborn.

Official Title
-----------------
Non-invasive Chromosomal Examination of Trisomy

Conditions
-----------------
Trisomy 21

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is at least 18 years old and can provide informed consent. Subject is planning a hospital delivery. Subject has a singleton pregnancy with a documented gestational age between 10 weeks, 0 days, and 14 weeks, 2 days, inclusive, at the time of the study blood sample collection. Subject is planning to undergo combined first trimester prenatal screening that includes NT measurement, and when indicated, serum screening with total or free β-hCG and PAPP-A. Exclusion Criteria: Subject has known aneuploidy. Subject has active or history of malignancy requiring major surgery and/or systemic chemotherapy. Subject has a twin demise at any gestational age. Twin demise includes any reductions, spontaneous or elective, after sonographic identification of a second (or more) gestational sac. Any clinical, sonographic, or other testing that suggests twin demise would serve as an exclusion criterion.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Case<br>Patient with a trisomy 21 pregnancy confirmed by genetic testing. | |
| Control<br>Patients without a trisomy 21 pregnancy confirmed by either genetic testing or a normal newborn phenotype. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in sensitivity and specificity of Ariosa Harmony™ Prenatal Test (AUCt) and combined first-trimester screening for detection of T21. |  | Enrollment to delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pregnancy, Fetal aneuploidy, Trisomy 21, Down Syndrome, Prenatal screening, Non-invasive prenatal testing, First trimester, Combined screening, Nuchal translucency, PAPP-A, hCG, cell free DNA, cf DNA, DNA, Performance characteristics of non-invasive first trimester screening, Harmony Prenatal Test
Side Effects of Anti-PD-(L)-1 and Anti CTLA-A4 in the Non Small Cells Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The immune-related adverse events (irAEs) linked to the important activation of the immune system by new immunotherapy treatments in patients affected by Non-small-cell lung carcinoma (NSCLC) have not received a lot of systematic study or been monitored over time outside of clinical trials. This study aims to verify, on the basis of the data collected in a prospective and retrospective manner, that the side-effects due of anti-PD-(L)-1 or anti-CTLA-4 treatments observed in the target population of the controlled clinical trials are the same as in the general clinical population.

Official Title
-----------------
Census and Follow-up of the Side Effects in the New Immunotherapeutic Treatments Anti-PD-(L)-1 and Anti-CTLA-4 of the Non Small Cells Lung Cancer

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung, Drug-Related Side Effects and Adverse Reactions

Intervention / Treatment
-----------------
* Other: Consultation of the patient's medical files at the hospital


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient with NSCLC treated in Cliniques Universitaires Saint-Luc with immunotherapy in first or second line. Exclusion Criteria: The refusal to sign the consent.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 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 |
| --- | --- |
| NSCLC's patients<br>Patients with NSCLC treated in Cliniques Universitaires Saint-Luc with immunotherapy. Consultation of the patient's medical files at the hospital. | Other: Consultation of the patient's medical files at the hospital<br>* Gradation of the adverse events according to CTCAE scale 4.03 (June 2010).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Census and monitor of the side-effects due to the immunotherapy treatment. | Census of the side-effect type, severity according to the CTCAE and monitoring the side-effect's development. | Through study completion, an average of 20 months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immunotherapy, Anti-PD-(L)-1, Anti-CTLA-4
Comparison of Body Composition & Weight Change in Users of Progestin-only Contraception During the First Year of Use

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn if women gain weight using progestin-only methods of contraception and if so, how much. The investigators will look at users of two progestin-only methods: the levonorgestrel-containing intrauterine contraceptive (LNG-IUC) and the etonorgestrel (ENG) subdermal implant, and compare these users' weight change to that of users of a non-hormonal method, the copper intrauterine device. The primary hypothesis is that ENG implant and LNG-IUC users' weight and body composition will increase more than the copper-IUD users. The investigators will collect body composition data using dual-energy x-ray absorptiometry (DEXA), and collect information about diet and activity using validated questionnaires.

Official Title
-----------------
Comparison of Body Composition & Weight Change in Users of Progestin-only Contraception During the First Year of Use

Conditions
-----------------
Weight Change

Participation Criteria
=================
Eligibility Criteria
-----------------
The study has finished enrolling new participants. Inclusion Criteria: Participants between the ages of 18 and 45 years Participants starting the copper IUD or implant through their provider First study visit must occur within 14 days of method insertion Exclusion Criteria: DMPA in the past 16 weeks POPs, LNG-IUC, or the implant in the past 4 weeks Thyroid disease Autoimmune disease Diabetes (excluding gestational) History of eating disorder Currently taking antidepressants for < 6 months Currently taking antipsychotics Currently taking oral glucocorticoids (steroids, i.e. prednisone) for more than 6 months Currently breastfeeding Less than 6 months post-partum

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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 |
| --- | --- | --- |
| Weight | Compare changes in body weight and BMI measurements | Baseline and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition | Compare parameters including fat mass and percentage and central-to-peripheral fat ratios | Baseline and 12 months |
Diurnal Triglyceridemia in Relation to Alcohol Intake

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the impact of alcohol consumption in diurnal triglyceridemia in a free living situation.

Official Title
-----------------
Observational Study of Diurnal Triglyceridemia in Relation to Alcohol Intake

Conditions
-----------------
Healthy Subjects, Hyperlipidemias, Type 2 Diabetes Mellitus, Cardiovascular Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Patients with: Hyperlipidemia Type 2 Diabetes Mellitus Cardiovascular diseases Exclusion Criteria: Renal disease Liver disease Thyroid disease

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

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 |
| --- | --- |
| General population<br>Healthy volunteers,patients with hyperlipidemia,a known medical history of cardiovascular diseases or type 2 diabetes mellitus. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of diurnal triglyceridemia depend on alcohol intake | Capillary triglyceridemia was measured by a triglyceride testing device on six fixed time-points. | For 3 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gender differences in diurnal triglyceridemia by alcohol consumption |  | For 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ethanol, Lipemia, Postprandial, Triglyceride
A Comparison of Manual vs. Spontaneous Removal of the Placenta at Cesarean Section

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if there are differences in operative blood loss with manual vs. spontaneous removal of the placenta during cesarean section.

Detailed Description
-----------------
Patients undergoing scheduled cesarean deliveries are randomized to manual or spontaneous placental removal.

Official Title
-----------------
A Comparison of Manual vs. Spontaneous Removal of the Placenta at Cesarean Section

Conditions
-----------------
Pregnancy, Cesarean Section

Intervention / Treatment
-----------------
* Procedure: Manual placental removal at Cesarean delivery
* Procedure: Spontaneous placental removal at Cesarean delivery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All term pregnant women 18 years of age and older undergoing scheduled cesarean delivery at Strong Memorial Hospital. Exclusion Criteria: Prematurity (<37 weeks) Preoperative chorioamnionitis Vaginal delivery of fetus Emergency Cesarean Delivery Patient's OB not agreeable to participating in this study.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Manual placental removal at Cesarean delivery|nan|
|Procedure: Spontaneous placental removal at Cesarean delivery|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hematocrit levels (preoperatively and within 48 hours postoperatively) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of units of blood transfused intraoperatively and postoperatively |  |  | 
| Development of uterine infection (endometritis) |  |  | 
| Length of postoperative hospital stay |  |  | 
| Operative time |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cesarean delivery, Placental removal, Blood loss
PWS Outcomes Assessment Study

Study Overview
=================
Brief Summary
-----------------
This is a longitudinal study during which qualitative interviews will be conducted with caregivers of Soleno C601/C602 study subjects. There is an additional option for caregivers to collect video data of PWS patients doing specific activities of daily life. The purpose of this study is to understand the real-world and nuanced impact of a potential therapeutic on individual PWS patients. The results of this study will complement the outcomes being captured during the Soleno C601/C602 clinical studies. There is no treatment or intervention associated with this study.

Official Title
-----------------
PWS Outcome Assessment Study

Conditions
-----------------
Prader-Willi Syndrome

Intervention / Treatment
-----------------
* Other: Interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Key Inclusion Criteria for Interviews: Eligible caregivers must: Be willing and able to provide informed consent in English Care for a C601/C602 trial subject or potential trial subject Have access to a smartphone or the internet Be able to converse in English Key Inclusion Criteria for Video Capture: Eligible PWS participants for the optional daily life video capture must: Be willing and able to provide informed consent or assent. Be enrolled in the C601/C602 trial Be able to converse in English Have a caregiver who has access to an Apple or Android smartphone or has internet access and is willing to use a wi-fi-only device to record and upload videos Have a caregiver who is willing and able to record activity videos Exclusion Criteria: n/a

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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Interview|Qualitative Interview|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Meaningful Change in Symptom Categories | The percentage of caregivers reporting meaningful change in each of the symptom categories in the Study C601 treated arm versus the Study C601 placebo arm as measured by the five-point quantification scale anchored in the qualitative questions (Scale: 1=very meaningful negative change, 2=slightly meaningful negative change, 3=no meaningful change, 4=slightly meaningful change, 5=very meaningful positive change) | From baseline for interview #2 (Week 13-16), From baseline for interview #3 (Week 26-28), From baseline for interview #4 (Week 65-67) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prader-Willi Syndrome, PWS
Risk Factors and Complications of Ventral Hernia Repair

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate risk factors and complications of ventral hernia repair. A retrospective study of journal files with patients undergoing ventral hernia repair, and an analyses of complications by use of the Clavien-Dindo classification of surgical complications.

Official Title
-----------------
Risk Factors and Complications of Ventral Hernia Repair

Conditions
-----------------
Ventral Hernia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Surgically treated ventral hernia repair Exclusion Criteria: All surgically treated patients are included

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 |
| --- | --- |
| Surgical treatment of ventral hernia<br>Adult patients who underwent a ventral hernia Repair at Zealand University hospital | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identifying pre-operative risk factors by use of the Clavien Dindo classification. |  | 5 years |
A Pilot Study to Assess the Follow-up of Prostate Cancer Patients Who Have Undergone Radiotherapy Treatment

Study Overview
=================
Brief Summary
-----------------
This is a pilot study assessing the role of the general practitioner in performing follow-up reviews on men who have recently completed radical radiotherapy for prostate cancer. This will be measured primarily by assessing any changes to the patient's health-related quality of life which will be evaluated by the completion of questionnaires by the participant at each review visit. The study aims to confirm that patient outcome is identical, independent of whether follow-up is performed by a specialist or the patient's General Practitioner.

Official Title
-----------------
A Pilot Study in the Transfer of Follow-up Reviews to the General Practitioner for Prostate Cancer Patients Who Have Undergone Radiotherapy Treatment

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men with a tumour T1-3 stage prostate cancer and have had radical radiotherapy with curative intent Are between six and twelve months post-treatment completion Have completed all treatment for prostate cancer (including hormonal deprivation therapy) Have no evidence of metastatic disease ECOG performance status of between 0-1 Remains willing to comply with study requirements Has maintained contact with an individual general practitioner Exclusion Criteria: Persistent complications resulting from treatment defined as a minimum Grade 3 treatment toxicity Unable to complete self-administered questionnaires Are currently enrolled in a study that requires specialist follow-up Life expectancy of less than 6 months Surgery to remove the prostate Evidence of biochemical failure
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Reviewed by radiation oncologist<br> | |
| Reviewed by general practitioner<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the patient's health-related quality of life that will be assessed by the patient completing self-administered questionnaires |  | QOL questionnaires will be asked to be completed at baseline, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54 and 60 months |
Hypofractionated Radiotherapy Concomitantly With Weekly Boost for Breast Cancer Patients Treated With Conservative Breast Surgery

Study Overview
=================
Brief Summary
-----------------
This is a retrospective study on evaluation of the efficacy and the safety of a hypofractionated radiotherapy course with weekly concomitant boost for breast cancer patients treated with conservative breast surgery .

Official Title
-----------------
Retrospective Study Evaluating Hypofractionated Radiotherapy Concomitantly With Weekly Boost for Breast Cancer Patients Treated With Conservative Breast Surgery

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

Intervention / Treatment
-----------------
* Radiation: radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women aged from 18 and up to 55 years old. Histologically diagnosed with breast carcinoma (ductal and others ) All patients with conservative breast surgery. Including all patients with in all stages except those stage IV. All patients with clear free surgical margin. patients received hypofractionated radiotherapy with weekly concomitant boost Exclusion Criteria: Evidence of distant metastatic deposites. patients with mastectomy patients with prior irradiation to thoracic region. pregnancy or lactation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: radiotherapy|Hypofractionated radiotherapy concomitantly with weekly boost|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival | Disease Free survival | baseline |