linjc16/ctgov huggingface dataset:
A Non-interventional Prospective Study of 1-st Line Treatment Approaches in OVArian Cancer Patients With HRD+ Status in Russian Federation

Study Overview
=================
Brief Summary
-----------------
Study population will consist of HRD+ (BRCAm +/- positive genomic instability score according to used test system) OC with available medical history. It is estimated that approximately 400 patients will be enrolled in approximately 25 sites. Demographic and clinical characteristics, treatment approaches and outcomes in HRD+ patients with high-grade epithelial ovarian, primary peritoneal, and/or fallopian tube cancer will be collected at baseline and on prospective visits.

Official Title
-----------------
Multicentre, Non-interventional, Observational, Prospective Study to Evaluate 1-st Line Treatment Approaches in HRD+ Ovarian Cancer Patients in Russian Federation

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients ≥18 years of age; Willing and ability to provide written informed consent for participation in the study; Known status HRD+ (positive BRCAm test and/or positive Genomic Instability test); Patients with histologically confirmed diagnosis of high-grade IC-IV FIGO stages epithelial ovarian, primary peritoneal, and/or fallopian tube cancer; Completed primary treatment (surgery and/or 1st line CT +/- bevacizumab) no more than 3 months after completion of primary treatment. Exclusion Criteria: Patients participating in other clinical studies

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 |
| --- | --- | --- |
| To describe the demographic and clinical characteristics of the patient population with HRD-positive OC (HRD+ BRCAwt and HRD+ BRCAm) | Demographic and baseline clinical characteristics will be summarized descriptively for the entire cohort of eligible patients. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe diagnostic and primary treatment approaches (surgery, first line chemotherapy+/-bevacizumab) of HRD+ with high-grade, epithelial ovarian, primary peritoneal, and/or fallopian tube cancer in routine practice | population and the maintenance regimens initiated after the primary OC therapy . | 18 months | 
| To describe first-line maintenance treatment approaches | population and the maintenance regimens initiated after the primary OC therapy . | 18 months |
Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1558 in Healthy Adult Volunteers

Study Overview
=================
Brief Summary
-----------------
This study aims to compare the pharmacokinetics and safety following administration of DWJ1558 and co-administration of DWC202310 and DWC202311 in healthy volunteers.

Official Title
-----------------
Bioequivalence Study to Compare the Pharmacokinetics and Safety Following Administration of DWJ1558 and Co-administration of DWC202310 and DWC202311 in Healthy Volunteers

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: DWJ1558
* Drug: DWC202310 and DWC202311


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 19 year old Exclusion Criteria: Pancreatitis Diabetic ketoacidosis

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention: DWJ1558<br> | Drug: DWJ1558<br>* DWJ1558<br>|
| Experimental: Intervention: DWC202310 and DWC202311<br> | Drug: DWC202310 and DWC202311<br>* Co-administration of DWC202310 and DWC202311<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax,ss of DWJ1558 | Maximum plasma concentration at steady-state(Cmax,ss) of DWJ1558 | At pre-dose (0 hour), and post-dose 1 to 72 hour. | 
| AUCt of DWJ1558 | Area under the curve from the time of dosing to the last measurable concentration(AUCt) of DWJ1558 | At pre-dose (0 hour), and post-dose 1 to 72 hour. |
PREDICTION OF GERMLINE BRCA 1/2 GENES FROM HEALTHY OVARIES

Study Overview
=================
Brief Summary
-----------------
The project aims at enhancing performance metrics and prospectively validating a radiogenomics model based on ovarian US images for predicting germline breast cancer susceptibility gene 1 and/or 2 (BRCA) status in women with healthy ovaries. The project is divided in two operational phases: Retrospective phase AIM 1: To define and implement a proper and fine-tuned image preprocessing pipeline on the existing dataset; AIM 2: To enlarge dataset size with new real images from different centers and apply data augmentation techniques, deep neural network models combined with the aforementioned handcrafted imaging features from radiomics analysis; Prospective phase AIM 3: To further cross-validate the predictive model on US images acquired prospectively in an observational multicenter study.

Official Title
-----------------
PREDICTION OF GERMLINE BRCA 1/2 GENES PATHOGENETIC VARIANTS FROM HEALTHY OVARIES ULTRASOUND IMAGES: RADIOGENOMICS AS AN INNOVATIVE TOOL TO PREVENT BRCA-RELATED CANCERS

Conditions
-----------------
BRCA Mutation, Ovarian Cancer, Ultrasound Therapy; Complications

Intervention / Treatment
-----------------
* Diagnostic Test: Germinal BRCA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Availability of gBRCA1/2 test results Transvaginal pelvic US performed providing at least one picture of one healthy ovary US images stored in .dicom format. Exclusion Criteria: Personal diagnosis of OC Ovarian abnormal findings (eg. ovarian endometriomas, dermoid cyst, ovarian cystoadenofibroma, ovarian borderline tumour…) with the exception of functional cysts at pelvic US gBRCA1/2 testing results nor provided by an ISO 1589 accredited laboratory Refusal to provide written informed consent
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Germinal BRCA|We will conduct a multicenter prospective observational study aimed at automatically implementing the predictive model and collecting US images of healthy ovaries from patients tested for germline BRCA pathogenetic variants according to current indications.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiogenomics model for predicting germline breast cancer. | The project aims at enhancing performance metrics and prospectively validating a radiogenomics model based on ovarian US images for predicting germline breast cancer susceptibility gene 1 and/or 2 (BRCA) status in women with healthy ovaries. | 36 months |
Cochlear Implantation in the Elderly

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to demonstrate that cochlear implantation is an effective, reasonable, and viable long-term option within a very elderly population

Official Title
-----------------
RELEVANCE OF COCHLEAR IMPLANTATION IN THE VERY ELDERLY: LENGTH OF DURATION AND OUTCOMES

Conditions
-----------------
Cochlear, Implant

Intervention / Treatment
-----------------
* Other: Measuring the vocal audiometry of patients.
* Other: Measuring data loging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria : 80 years or more Primo-implantation Exclusion Criteria : Under 80 years Bilateralisation Explantation or re-implantation

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient elderly implanted<br>Patients over 80 years old, primo implanted between 2011 and 2021 | Other: Measuring the vocal audiometry of patients.<br>* Measuring vocal audiometry at 6 months, 1 year and annually until the last date of follow-up<br>Other: Measuring data loging<br>* Measuring data loging at 6 months, 1 year and then annually until last date of follow-up<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vocal audiometry |  | Through study completion, an average of 1 year | 
| Data Loging |  | Through study completion, an average of 1 year |
Predicting Outcomes of Distal Radius Fractures: a Surgeon Survey

Study Overview
=================
Brief Summary
-----------------
The goal of this surgeon survey is to find out if orthopedic and trauma surgeons can predict outcomes in older adults with distal radius fractures. The main questions it aims to answer are: Can orthopedic and trauma surgeons effectively predict which treatment would benefit a patient the most in terms of good outcome versus poor outcome (based on Δ PRWE) following casting or surgical treatment for displaced intra-articular distal radius fractures? What are the perspectives of trauma surgeons and orthopedic surgeons on current literature? What factors direct trauma surgeons and orthopedic surgeons to surgery?

Official Title
-----------------
Surgery or Casting in Older Adults With Intra-articular Distal Radius Fractures? A Surgeon Survey in Predicting the Outcome

Conditions
-----------------
Distal Radius Fractures, Survey, Distal Radius Fracture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dutch orthopedic and trauma surgeons Residents Experience with at least five surgeries of distal radius fractures in the past 3 years Exclusion Criteria: No experience with distal radius fractures
Sexes Eligible for Study
-----------------
All

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of correct predictions of the treatment outcome | Correct predictions of surgeons in total and per case. | From enrollment to the end of the data collection, up to 10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
distal radius fracture, surgeon survey, surgeon, survey, predicting outcomes, preferences
Level of Anxiety in Patients Undergoing Invasive Foot Surgery

Study Overview
=================
Brief Summary
-----------------
Preoperative anxiety has been studied in different medical disciplines, but it is unknown in minor surgical procedures such as foot nail surgery. This study aimed to determine the prevalence of preoperative anxiety and postoperative pain in foot nail surgery. The validated Amsterdam preoperative anxiety and information scale (APAIS) was used to evaluate preoperative anxiety and the need for information in 155 patients undergoing foot nail surgery. In addition, a questionnaire was used to collect other variables such as age, sex and educational level. The verbal numeric scale was employed to value the postoperative pain after 24 h.

Official Title
-----------------
Preoperative Anxiety Level and Associated Factors in Patients Undergoing Minimally Invasive Osteoarticular Foot Surgery

Conditions
-----------------
Anxiety Postoperative, Surgery

Intervention / Treatment
-----------------
* Procedure: foot surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be over18 years old. ASA I and II (American Society of Anesthesiologists). autonomous capacity to fill out the surveys and participate in the study Exclusion Criteria: mental and/or emotional disorders. incapacity to understand. people medicated with anxiolytics before the surgery. chronic pain in the foot and/or analgesic treatment for chronic pain. did not fulfill the postoperative recommendations. contraindication to the study's medical guideline.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Anxiety levels<br>pre-surgical anxiety levels in patients undergoing minimally invasive osteoarticular foot surgery | Procedure: foot surgery<br>* minimally invasive osteoarticular foot surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pre-surgical anxiety levels | Amsterdam Pre-Operative Anxiety and Information Scale (APAIS) using a 5-point Likert scale, where 1 = not at all and 5 = total. | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anxiety, surgery, minor surgical procedures, postoperative pain
Digital Impression in Neonates

Study Overview
=================
Brief Summary
-----------------
The goal of this [clinical trial] is to [explore the attitudes of guardians with different educational background regarding the technique of impression registration as well as the compliance to using feeding appliances ] in [neonates]. Researchers will compare [conventional impression technique to digital impression]

Official Title
-----------------
Diagnostic Evaluation and Guardian Assessment of Using Digital Impression in Neonates Versus the Conventional Techniques.

Conditions
-----------------
Unilateral Complete Cleft Lip and Palate

Intervention / Treatment
-----------------
* Other: Conventional impression
* Other: Digital impression


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with unilateral complete cleft lip and palate neonates Exclusion Criteria: infants and children bilateral cleft lip and palatal incomplete cleft lip

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 28 Days

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Paired design Same patients receive conventional impression and digital
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional impression<br> | Other: Conventional impression<br>* Palatal impressions obtained using an irreversible hydrocolloid impression material<br>|
| Experimental: Digital impression<br> | Other: Digital impression<br>* after obtaining stone models from conventional impression material, stone models were scanned using the I700 (Medit) scanner and Patients were directly scanned intraorally using an intraoral 3D scanner Subsequently, the printed 3D model scan data of the seven patients were then used for standard triangulated language (STL)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Deviation of linear measurments | The stone models obtained from conventional methods and 3D printed models obtained from the intraoral scanning were measured directly three times using an Vernier Fowler Calipers (WESTport Corporation, NY.), | up to 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of gaurdian' perception and experience | The assessment of mothers' perception and experience regarding Pre-surgical infant orthopedics (PSIO) was executed using 16 validated preformed question. A questionnaire assess parents' satisfaction concerning PSIO | up to 1 month |
A Study to Assess the Effects of CT-868 Treatment on Glucose Homeostasis in Participants With Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study will be conducted primarily to evaluate the effects of CT-868 on glucose homeostasis in participants with Type 1 Diabetes Mellitus.

Official Title
-----------------
A Randomized, Double-Blind, Placebo and Comparator-Controlled Crossover Study to Assess the Effects of CT-868 Treatment on Glucose Homeostasis in Participants With Type 1 Diabetes

Conditions
-----------------
Type 1 Diabetes

Intervention / Treatment
-----------------
* Drug: CT-868
* Drug: Placebo
* Drug: Victoza


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female or male adults with Type 1 diabetes Ages 18-65 years Type 1 DM for at least 3 years Using an insulin pump or multiple daily injections (MDI) for at least 3 months BMI 25.0 - 35.0 Exclusion Criteria: Significant medical history Uncontrolled diabetes History of surgical treatment for weight loss History of malignancy

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CT-868<br>SC injection of CT-868 Intervention | Drug: CT-868<br>* CT-868<br>|
| Placebo Comparator: Placebo<br>SC injection of placebo matching CT-868 dose | Drug: Placebo<br>* Placebo as SC Injection<br>|
| Active Comparator: Victoza<br>SC injection of active comparator | Drug: Victoza<br>* Victoza as active comparator as SC Injection<br>* Other names: Liraglutide;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess area under the curve (AUC) in glucose metabolism during MMTT |  | Baseline up to 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess changes in continuous glucose monitoring (CGM) measures |  | Baseline up to 4 days | 
| Area under the acetaminophen concentration-time (AUC) |  | 0 - 300 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 1 Diabetes, Obesity, Overweight
A Real-World Study of Atezolizumab in Combination With Platinum-Based Doublet Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-IIIB NSCLC

Study Overview
=================
Brief Summary
-----------------
This is a descriptive observational study, in which data are collected in an epidemiological fashion and prospective. This study does not intend to intervene the current medical practice of the recruited patients.

Official Title
-----------------
A Real-World Study of Atezolizumab in Combination With Platinum-Based Doublet Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-IIIB Driver Gene-Negative Non-Small Cell Lung Cancer (NSCLC)

Conditions
-----------------
NSCLC

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be ≥18 years. Provision of fully informed consent prior to any study specific procedures. Previously untreated, histologically confirmed resectable stage II, IIIA, IIIB (N2) (AJCC stage VIII) NSCLC; cTNM stage can be confirmed by PET-CT or pathological biopsy; resectable stage II non-small cell lung cancer is defined as radical resection as assessed by a qualified thoracic surgeon; resectable is resectable and potentially resectable as defined by the Expert Consensus on Multidisciplinary Diagnosis and Treatment of Stage III Non-small Cell Lung Cancer (2019 version); resectable includes IIIA (N0-1), some single-station mediastinal lymph node metastases with N2 and some T4 (satellite nodules present in adjacent lobes) N1; potentially resectable includes some stage IIIA and IIIB, including single-station N2 mediastinal lymph node short diameter < 3 cm stage IIIA NSCLC, potentially resectable T3 or T4 central tumors; Solid/solid pulmonary nodules, not pure ground-glass opacity (GGO), are strongly recommended for pathological puncture verification. According to the RECIST 1.1 standard, the patient must have at least one measurable lesion. Exclusion Criteria: None Exclusion Criteria: -

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 |
| --- | --- | --- |
| MPR Rate | Neoadjuvant therapy-induced tumor regression in pathologically residual tumors <10% | 2 years |