linjc16/ctgov huggingface dataset:
Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer (I)

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate whether Sentinel Node biopsy can be performed without the use of lymphoscintigraphy and with ICG as a mono-tracer in women with vulvar cancer, unifocal tumor < 4 cm (clinical stage IB and II). Further, to investigate the accuracy of combined PET-CT and ultrasound (US) of the groins with US-guided biopsy of suspicious lymph nodes for the identification of macro-metastases in women with vulvar cancer, unifocal tumor < 4 cm.

Official Title
-----------------
Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer

Conditions
-----------------
Vulvar Cancer, Sentinel Lymph Node

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with primary vulva cancer, FIGO stage IB (tumor < 4 cm) Patients with unifocal recurrence in the vulva (tumor < 4 cm) located on the side where the patient is surgically naïve in the groin Exclusion Criteria: Prior irradiation of the vulva or groins Prior SNB or inguinal lymphadenectomy in the relevant groin Known allergy to ICG or iodine (ICG contains 5% sodium iodine)

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 |
| --- | --- | --- |
| Sentinel Node detection rate | SN detection rate with ICG and 99mTc-Nanocoll alone perioperatively, where lymphoscintigraphy is blinded, in patients with vulvar cancer (tumor < 4 cm) without clinical suspicion of metastases to the inguinal lymph nodes. | Three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity, specificity, PPV and NPV | Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of FDG PET-CT and US combined with US-guided biopsy of suspicious lymph nodes for the identification of macro-metastases in the groins | Three years |
Turkish Version of Digital Eye Strain Questionnaire (DESQ)

Study Overview
=================
Brief Summary
-----------------
The aims of this study were to perform cultural adaptation of the DESQ and provide information regarding the factor structure, reliability and validity of the instrument in Turkish speaking adults.

Official Title
-----------------
Validity and Reliability of the Turkish Version of Digital Eye Strain Questionnaire (DESQ)

Conditions
-----------------
Cultural Adaptation, Reliability, Validity, Adults, Eye Strain

Intervention / Treatment
-----------------
* Other: Cultural adaptation, reliability and validity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between the ages of 18-65 years People who spend two or more continuous hours a day on their digital devices (computer, tablet, smartphone) or use more than one device Exclusion Criteria: History of ophthalmic surgery or active ocular disease Participants who did not understand the instructions or did not sign a consent form were excluded

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Cultural adaptation, reliability and validity|Cross-cultural Adaptation, Reliability and Validity of the Turkish Version of the DESQ|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DESQ | Digital Eye Strain Questionnaire (DESQ) is a thirteen-item self-report scale in a yes-no format designed to offer a measure of complaints related to digital eye strain syndrome (DES) | 10 minutes |
Expanded Access to ABBV-400

Study Overview
=================
Brief Summary
-----------------
This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to ABBV-400 prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

Official Title
-----------------
Expanded Access to ABBV-400

Conditions
-----------------
Non-Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: ABBV-400


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - The participant must not be eligible for an ABBV-400 clinical trial.

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: ABBV-400|Intravenous (IV) Infusion|

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
-----------------
Expanded Access, Pre-approval Access, Compassionate Use, Special Access Program, Named Patient Basis, Special Access Scheme
Discovering Novel Cancer Treatment Options Using a Comprehensive NGS-based Liquid Molecular Testing Panel in the Community Setting (DINOSAur II)

Study Overview
=================
Brief Summary
-----------------
To prospectively identify cancer patients whose tumors express specific molecular markers targeted by therapeutic agents from a comprehensive l i q u i d molecular test, for the purpose of selecting the most clinically appropriate treatment in a pragmatic two arm trial.

Official Title
-----------------
Discovering Novel Cancer Treatment Options Using a Comprehensive NGS-based Liquid Molecular Testing Panel in the Community Setting. (DINOSAur II)

Conditions
-----------------
Stage III Solid Tumors, Stage IV Solid Tumors

Intervention / Treatment
-----------------
* Diagnostic Test: Comprehensive liquid molecular panel test
* Other: EORTC QLQ-30


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have given informed consent in accordance with the methods and procedures of this study Diagnosis of cancer (stage 3 and stage 4; solid tumors only) requiring medical care Patients who have not received treatment related to his/her cancer Patients who are willing to sign a release of medical records to the research team Male and female patients ≥18 years of age Patients under oncology care Sufficient clinical status for collection of blood sample within usual care Exclusion Criteria: Patients considered minors in the jurisdiction where the protocol is conducted Patients who are prisoners and pregnant women Patients who cannot provide consent and did not sign a power of attorney

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 |
| --- | --- |
| Active<br>Newly diagnosed cancer patients. | Diagnostic Test: Comprehensive liquid molecular panel test<br>* Lab test<br>Other: EORTC QLQ-30<br>* Quality of life questionnaire<br>|
| Control<br>Historically diagnosed cancer patients. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (QLQ-C30) | The EORTC Core Questionnaire (QLQ-C30) includes six clearly distinguishable functioning scales that have been thoroughly tested and validated on an international level and that are available in 110 different language versions. The scaling of items is 1 (Not at all) to 4 (Very much), 1 (Very poor) to 7 (Excellent). The higher the score the better the quality of life. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the proportion of enrolling in clinical trials | To compare the proportion of enrolling in clinical trials between cancers patients who received the CLMT versus cancer patients with no CLMT. | 2 years |
Assessment of Safety and Satisfaction Toward COVID-19 Vaccines.

Study Overview
=================
Brief Summary
-----------------
This is a cross-sectional, web-based online survey done with the use of a Google Form-questionnaire to gather information from the general public regarding their knowledge, satisfaction, and tolerability about the COVID-19 vaccine.

Detailed Description
-----------------
A cross-sectional study was conducted. The subjects participating in the study are residents in Egypt. An online questionnaire, designed on Google Forms, was written in Arabic language and delivered to participants via social media (primarily Facebook, WhatsApp and Linkedin). The questionnaire comprised two categories of inquiries. The first is demographic data of the subject. The second is questions about COVID-19 vaccine-related data, such as whether had taken the vaccine or not, the type of vaccine administered, side effects encountered from the vaccine , if got enough information regarding the vaccine and where obtain the vaccine information from and if reluctant to taking the vaccine and the reasons for hesitancy. All participants were permitted to terminate the survey at any time of the study.

Official Title
-----------------
Assessment of Safety and Satisfaction Toward COVID-19 Vaccines: A Cross-sectional Study.

Conditions
-----------------
COVID-19 Vaccine Adverse Reaction

Intervention / Treatment
-----------------
* Other: COVID-19 Vaccine questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all adults (age ≥ 18 years) complete the questionnaire were considered eligible to participate in the survey. Exclusion Criteria: Incomplete questionnaires were excluded from the final analysis.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: COVID-19 Vaccine questionnaire|An online questionnaire, designed on Google Forms, was written in Arabic language and delivered to participants via social media (primarily Facebook, WhatsApp and Linkedin).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| headache incidence | Pecentage | 3 month | 
| fever incidence | Pecentage | 3 month | 
| fatigue incidence | Pecentage | 3 month | 
| pain at site of injection incidence | Pecentage | 3 month |
Immune Checkpoint Inhibitors(ICPis)-Induced Endocrine Immune-related Adverse Events (irAEs)

Study Overview
=================
Brief Summary
-----------------
Immune checkpoint inhibitor (ICI) includes agents that block cytotoxic T-cell-associated antigen 4 (CTLA-4), programmed cell death protein 1 (PD-1), and programmed cell death protein ligand 1 (PD-L1). Since the FDA-approval of the CTLA-4 inhibitor ipilimumab in 2011, ICI drugs have emerged as a powerful new tool in the treatment for several advanced cancers. Now indications for ICI have expanded dramatically due to their efficacy and include a wide array of cancer types. However, the administration of ICI, whereas, carry the risk of developing immune-related adverse events (irAEs) and may lead to serious and even fatal events. Endocrine dysfunctions are among the most common irAEs that have been reported in clinical trials with ICI, including thyroid dysfunction, hypopituitarism, primary adrenal insufficiency (PAI) and insulin-deficient diabetes (ICI-DM). However, it is difficult to acquire a complete picture of irAEs from randomized controlled trials (RCTs) due to limitations in the study design and realistic practicalities.

Official Title
-----------------
Endocrine-related Adverse Events Caused by Immune Checkpoint Inhibitors

Conditions
-----------------
Immune Checkpoint Inhibitor, Endocrine Toxicity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cancer patients who received one dose or more of PD-1/PD-L1 inhibitors Exclusion Criteria: Insufficient reported details Patients younger than 18 years old in a double-blind study where treatment allocation cannot be resolved

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 88 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 |
| --- | --- |
| Nanjing<br>The First Affiliated Hospital of Nanjing Medical University | |
| Zhengzhou<br>Henan Provincial People's Hospital | |
| Qingdao<br>The Affiliated Hospital of Qingdao University | |
| Urumqi<br>People' s Hospital of Xinjiang Uygur Autonomous Region | |
| Jinan<br>Shandong Provincial Hospital Affiliated to Shandong First Medical University | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| irAEs | Immune Checkpoint Inhibitors Induced Endocrine Immune related Adverse Events | through study completion, an average of 2 year |
Prediction Model for Inadequate Weight Loss After Sleeve Gastrectomy

Study Overview
=================
Brief Summary
-----------------
This study aims to develop and validate a prediction model for estimating the probability of inadequate weight loss one year after sleeve gastrectomy.

Detailed Description
-----------------
Inadequate weight loss (IWL) is a major problem after sleeve gastrectomy, leading to the recurrence of obesity-related comorbidities and increased risk of revision surgery. It is important to identify the high-risk individuals for IWL before surgery so that clinicians can initiate more rigorous weight monitoring and management strategies. Therefore, this study aims to develop a prediction model using preoperative clinical and laboratory data to estimate the risk of IWL one year after sleeve gastrectomy, and then validate it using two separate datasets.

Official Title
-----------------
Prediction Model for Inadequate Weight Loss After Sleeve Gastrectomy

Conditions
-----------------
Bariatric Surgery, Sleeve Gastrectomy, Weight Loss

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI ≥ 27.5 kg/m2; 16 years ≤ age ≤ 70 years; Complete preoperative data and one-year follow-up information Exclusion Criteria: Patients who did not undergo SG; Incomplete follow-up information; Patients with a history of pituitary or thyroid disease; Female patients who conceived within one year after surgery

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 70 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 |
| --- | --- | --- |
| Area under receiver operating characteristic curve (AUC) of the prediction model | AUC reflects the discriminatory ability of the model, which was measured in this study. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brier score of the prediction model | Brier score reflects the calibration of the model, which was measured in this study. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleeve Gastrectomy, Weight Loss, Prediction Model
Precision Cancer Therapy in Rare Cancers

Study Overview
=================
Brief Summary
-----------------
Some rare cancers are hard-to-treat and patients have a poor prognosis. It is known that some of these patients have targetable molecular alterations, and some benefit from targeted drugs. However in many cases these drugs are not approved for the rare cancers. In this study the aim is to do advanced molecular diagnostics to identify possible targets for therapy, and to treat accordingly.

Detailed Description
-----------------
All patients will have the tumour cells diagnosed with a large genepanel, analyzing more than 500 genes on DNA / RNA level. Patients will be treated based on the molecular characteristics of the tumor cells.

Official Title
-----------------
The MATRIX Clinical Studies of Precision Cancer Therapy for Rare Cancers

Conditions
-----------------
Rare Malignant Neoplasm

Intervention / Treatment
-----------------
* Drug: Imatinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ECOG 0-2, identified biomarker, reasonable biochemistry Exclusion Criteria: ECOG 3-5 serious other diseases

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 99 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: simon two stage model
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment according to genetic alterations<br>treatment according to genetic alterations | Drug: Imatinib<br>* imatinib treatment based on molecular alterations<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiological response evaluation at 16 weeks of treatment | Standard radiological response evaluation, like RECIST criteria. | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Molecular analyses predicting responses | Sequencing of tumor material and blood samples | 2 years |
Outcomes After Epigastric Hernia Repair in Women.

Study Overview
=================
Brief Summary
-----------------
Nationwide cohort study on women undergoing epigastric hernia repair

Detailed Description
-----------------
Women have the highest prevalence of epigastric hernia repair. Outcomes after epigastric hernia repair are rarely reported independently, although pathology and surgical techniques may be different than for other primary ventral hernias. The aim of this study was to evaluate long-term outcomes after epigastric hernia repairs in women on a nationwide basis. Methods Nationwide cohort study from the Danish Hernia Database. Complete data from women undergoing elective epigastric hernia repair during a 12-year period (2007-2018) was extracted. A 100% follow-up was obtained by combining data from the National Civil Register. The primary outcome was operation for recurrence, secondary outcomes were readmission and operation for complications. Outcomes for open sutured repair, open mesh repair mesh, and laparoscopic repairs were compared.

Official Title
-----------------
Long-term Outcomes After Epigastric Hernia Repair in Women - a Nationwide Database Study

Conditions
-----------------
Epigastric Hernia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: females undergoing epigastric hernia repair in Denmark Exclusion Criteria: emergency repair umbilical hernias incisional hernias males

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| hernia recurrence | reoperation for recurrence | end of study |
Impact of Immuno-Oncologic Agent on Neoadjuvant Chemotherapy in Triple Negative Breast Cancer

Study Overview
=================
Brief Summary
-----------------
It analyzes the Tumor microenvironment(TME) changes in non pathologic complete response(pCR) subjects among subjects who were administered neoadjuvant pembrolizumab and those who were not administered neoadjuvant pembrolizumab for triple negative breast cancer. (Neoadjuvant Weekly paclitaxel, Carboplatin +- Pembrolizumab followed by Doxorubicin, Cyclophosphamide +- Pembrolizumab regimen)

Official Title
-----------------
Impact of Immuno-Oncologic Agent on Neoadjuvant Chemotherapy in Triple Negative Breast Cancer

Conditions
-----------------
Triple Negative Breast Cancer, Neoadjuvant Chemotherapy, Pembrolizumab, Tumor Microenvironment

Intervention / Treatment
-----------------
* Genetic: Visium, Whole Genome Sequencing(WGS)/Whole Transcriptome Sequencing(WTS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Triple negative breast cancer Subjects administered neoadjuvant Weekly paclitaxel, Carboplatin followed by Doxorubicin, Cyclophosphamide add Pembrolizumab or not Non pCR patients who are undergoing surgery after neoadjuvant chemotherapy Sign to informed consent Exclusion Criteria: Patients with difficulty in obtaining sufficient samples

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Subjects administered Neoadjuvant Pembrolizumab<br>Neoadjuvant Weekly paclitaxel, Carboplatin followed by Doxorubicin, Cyclophosphamide add Pembrolizumab | Genetic: Visium, Whole Genome Sequencing(WGS)/Whole Transcriptome Sequencing(WTS)<br>* Visium : Spatial transcriptomics WGS/WTS : detection of somatic mutation<br>|
| Subjects not administered Neoadjuvant Pembrolizumab<br>Neoadjuvant Weekly paclitaxel, Carboplatin followed by Doxorubicin, Cyclophosphamide | Genetic: Visium, Whole Genome Sequencing(WGS)/Whole Transcriptome Sequencing(WTS)<br>* Visium : Spatial transcriptomics WGS/WTS : detection of somatic mutation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genomic profiling will be assessed by tissue and blood samples(analyze the TME changes) | Tissue and blood will be tested for Spatial transcriptomics, WGS(Wilcoxon rank sum test or Chi-square test, cell-cell interaction) | 3year |