linjc16/ctgov huggingface dataset:
PRostate Olaparib Real World Evidence Study

Study Overview
=================
Brief Summary
-----------------
This French non-interventional prospective multicenter cohort study is conducted to study the added value of olaparib in the treatment of patients with mCRPC in the real world setting in terms of treatment sequencing, effectiveness, safety and BRCA testing patterns and thus inform future clinical practice.

Official Title
-----------------
a French Observational Prospective Multicenter Study of Adult Patients Treated in the Real-life Setting With Olaparib for the Treatment of Metastatic Castration-resistant Prostate Cancer

Conditions
-----------------
Metastatic Castration-resistant Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult male patients (≥ 18 years old) With metastatic castration-resistant prostate cancer - Who have initiated olaparib within the last two months of study entry, or for whom the decision to be treated with olaparib has been made by their physician Who have been informed and are not opposed to this data collection Exclusion Criteria: Patients opposed to the collection of their data Patients participating in a clinical trial with an investigational prostate cancer targeted drug within 30 days prior to Olaparib initiation

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

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
| Time to treatment discontinuation (TTD) | TTD is defined as the time from the first day of olaparib treatment to the day that olaparib stopped for whatever reason or the date of death due to any cause, whichever comes first | Up to 36 months from olaparib initiation |
Novel Predictors of Post Spinal Hypotension in Cesarean Sections: Evaluating Jugular Vein Collapsibility Index and Shock Indices

Study Overview
=================
Brief Summary
-----------------
Jugular vein collapsibility index and shock indices (Shock index, Modified Shock Index, Diastolic Shock Index) may be useful in estimating post spinal hypotension in cesarean section operations. Evaluation on the accuracy and effectiveness of these indices can contribute to the early diagnosis and management of hypotension. The main purpose of this study is to evaluate the effectiveness of shock indices in predicting the possibility of post spinal hypotension in cesarean section operations.

Official Title
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Novel Predictors of Post Spinal Hypotension in Cesarean Sections: Evaluating Jugular Vein Collapsibility Index and Shock Indices

Conditions
-----------------
Cesarean Section Complications, Regional Anesthesia Morbidity, Hemodynamic Instability, Shock

Intervention / Treatment
-----------------
* Diagnostic Test: Right Jugular Vein Collapsibility Index


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Pregnant women between the ages of 18-45 who had a planned cesarean section and approved to participate in the study and to apply spinal anesthesia Exclusion Criteria: Patients with Preeclampsia, Eclampsia, HELLP syndrome

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Right Jugular Vein Collapsibility Index|Ultrasonography will be used to evaluate the diameter of the jugular vein (minimum and maximum values) and carotid diameter. The jugular vein collapsibility index will be measured by the anesthesiologist using non-invasive ultrasonography. Jugular vein collapsibility index will be calculated using the measured diameters.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction of hypotension | To evaluate the ability of the jugular vein collapsibility index and shock indices (Shock index, Modified Shock Index, Diastolic Shock Index) to predict post spinal hypotension in cesarean section surgeries. | 15 min |
A Post-Marketing Surveillance Study to Assess the Safety of Oral Azacitidine Maintenance Therapy in Korean Patients With Acute Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational study is to assess the real-world safety of maintenance therapy with oral azacitidine in Korean participants with acute myeloid leukemia (AML) who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction chemotherapy with or without consolidation therapy, and who are not eligible for hematopoietic stem cell transplantation (HSCT).

Official Title
-----------------
Onureg® (Oral Azacitidine) Post-Marketing Surveillance in Korean Patients With Acute Myeloid Leukemia

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

Intervention / Treatment
-----------------
* Drug: Oral azacitidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult participants 19 years of age or older Participants who receive oral azacitidine according to the approved label For the first 2 years after marketing authorization, all participants who have received or are receiving oral azacitidine will also be registered Participants who sign the informed consent form Exclusion Criteria: Participants who are prescribed oral azacitidine for therapeutic indications not approved in Korea Participants for whom oral azacitidine is contraindicated per the Korean prescribing information approved by ministry of food and drug safety

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 |
| --- | --- |
| Participants receiving oral azacitidine maintenance therapy<br> | Drug: Oral azacitidine<br>* Maintenance therapy according to the approved label<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events (AES) | The type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs to oral azacitidine | Up to 12 months |
Pre- and Post TAVI Cognitive Functioning and Intraoperative Carotid Flow Measurements

Study Overview
=================
Brief Summary
-----------------
Purpose: Measuring and optimize the usability of the BAMCOG (games to measure cognitive functioning) Concurrent validation of BAMCOG with MoCA to see if BAMCOG can serve as a monitoring instrument/screener Determination of carotid flow/cerebral blood flow pre- and post implant of prosthesis of aortic valve by ultrasound doppler measurements

Official Title
-----------------
Usability Study of the BAMCOG Followed by Concurrent Validation of the BAMCOG With the MoCA as a Monitoring Instrument for Perioperative Cognitive Function

Conditions
-----------------
Cognitive Impairment, Older People--Abuse of, Aortic Stenosis, Severe

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 65 years old Scheduled for TAVI surgery Able to play games on a tablet For usability part > MoCA score of 26 or higher Near native dutch speaker Exclusion Criteria: Mental disorder (unable to play games) Alcohol abuse (women <15 and men >22 alcoholic drinks/week) No informed consent Atrial fibrillitation (for ultrasound doppler)

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- | --- |
| Usability of BAMCOG |  | 3 months preoperative | 
| Concurrent validation of BAMCOG with MoCA |  | 3 months preoperative - 3 months postoperative | 
| Cerebral perfusion/carotid flow measurements |  | Peroperative |
the Ameliorating Effects of Antioxidant Gel on Female Arousal Disorder and Sexual Dysfunction

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the quality of sexual life of females with sexual interest or arousal disorder before and after accurate application of a formulated emulgel made from natural ingredients, including kaempferol as an API

Official Title
-----------------
Randomized Controlled Trial Studying the Ameliorating Effects of Kaempferol Emulgel on Female Arousal Disorder and Sexual Dysfunction

Conditions
-----------------
Female Sexual Dysfunction

Intervention / Treatment
-----------------
* Drug: Kaempferol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women between the ages of 28 and 45 had regular periods and previous menstrual bleeding lasted between three and seven days Exclusion Criteria: sensitivity to drug of therapy, cancer, autoimmune illness, smoking or drinking, liver disease, irregular menstruation

Ages Eligible for Study
-----------------
Minimum Age: 28 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kaempferol group<br>Kaempferol gel received the vaginal gel containing antioxidant extract every day for seven days. Then, the treatment continued for two months, twice weekly | Drug: Kaempferol<br>* Kaempferol<br>|
| Placebo Comparator: Placebo group<br>Plain formulation received the vaginal gel containing antioxidant extract every day for seven days. Then, the treatment continued for two months, twice weekly | Drug: Kaempferol<br>* Kaempferol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Female Sexual Function Index | The FSFI comprises 19 questions of sexual function in six independent areas consisting of desire, arousal, lubrication, orgasm, sexual satisfaction , pain from sex. | two months |
Evaluating Trends in Anaplastic Thyroid Cancer Patients' Clinical Study Experiences

Study Overview
=================
Brief Summary
-----------------
Clinical trials can sometimes favor certain demographic groups. Additionally, there is limited research that delves into the factors that influence participation in clinical study, both positive and negative. The goal is to identify the obstacles and challenges that prevent participation in anaplastic thyroid cancer clinical research, as well as the reasons for withdrawal or discontinuation. Insights gained from this study will ultimately benefit those with anaplastic thyroid cancer who may be invited to participate in clinical research in the years to come.

Official Title
-----------------
A Critical Analysis of Anaplastic Thyroid Clinical Trials: Perspectives From Patient Experiences

Conditions
-----------------
Anaplastic Thyroid Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with anaplastic thyroid cancer Willing to comply with all study related procedures and assessments Capable of giving signed informed consent, which includes compliance with requirements and restrictions listed in the informed consent form (ICF) and in the protocol Exclusion Criteria: No documented diagnosis of anaplastic thyroid cancer Any serious and/or unstable pre-existing medical disorders Pregnant or lactating woman

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Number of anaplastic thyroid cancer patients who decide to enroll in a clinical study |  | 3 months | 
| Rate of anaplastic thyroid cancer patients who remain in a clinical study to completion |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anaplastic thyroid cancer
Hemorrhagic Myocardial Infarction Detection by Biomarkers

Study Overview
=================
Brief Summary
-----------------
Pilot trial to determine diagnostic efficacy of post-reperfusion troponin kinetics in detection of hemorrhagic myocardial infarction

Official Title
-----------------
Hemorrhagic Myocardial Infarction Detection With Biomarkers

Conditions
-----------------
Acute Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Index STEMI Coronary angiogram with PCI to occur irrespective of the onset of the symptoms. Ability to provide informed consent for themselves Exclusion Criteria: History of prior myocardial infarction, Cardiogenic shock, Patients who present with current cardiac arrest Any contraindication to cardiac CMR (claustrophobia, pacemaker or cardiac defibrillator, known allergy to gadolinium), Presence of permanent atrial fibrillation, Unconscious patient, Severe renal insufficiency (creatinine clearance ≤ 30 ml/min/m2 or renal replacement therapy), Women who are pregnant or breastfeeding. Women of reproductive potential must have a negative pregnancy test.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Diagnostic Threshold | Levels of markers in hemorrhagic infarct vs. non-hemorrhagic infarct | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
STEMI, Troponin, Intramyocardial Hemorrhage, Cardiac MRI
Population Pharmacokinetics and Dose Optimization of Caspofungin in Adolescents

Study Overview
=================
Brief Summary
-----------------
Caspofungin (CAS) is used to prevent and treat invasive fungal infections patients older than 3 months. However, the optimal dosing strategy of CAS is lacking in adolescents from 12 to 17 years old, especially those undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT), who are vulnertable to fungal infections. The study aimed to establish a population pharmacokinetic (PPK) model and assess the dosing schemes of CAS in adolescents with allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Official Title
-----------------
Population Pharmacokinetics and Dose Optimization of Caspofungin in Adolescents With Allogeneic Hematopoietic Stem Cell Transplantation

Conditions
-----------------
Invasive Fungal Infections

Intervention / Treatment
-----------------
* Drug: Caspogunfin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The adolescents (12 - 17 years) underwent allo-HSCT Use caspofungin for the prevention or treatment of fungal infections Exclusion Criteria: Intolerable to caspofungin Participate into other clinical studies There are conditions that researchers do not consider it appropriate to join the research.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 17 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Caspogunfin|No specific interventions were administrated. Participants receive interventions as part of routine medical care, where CAS was infused intravenously over 60 min at a loading dose of 70 mg/m2 on day 1, followed by a maintenance dose of 50 mg/m2 (maximum: 70 mg daily).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The PTAs of AUC24/MIC90 for C. albicans , C. glabrata , and C. parapsilosis | The probability of target attainment (PTA) of the ratio of AUC24 (area under the concentration-time curve from 0 to 24 hours) and MIC90 (the lowest concentration of caspofungin at which 90% of the isolates were inhibited) (AUC24/MIC90) for C. albicans (0.06 mg/L), C. glabrata (450 mg/L), and C. parapsilosis (1185 mg/L) . | 1 day | 
| The PTAs of AUC24/MIC for various species of Candida spp isolates | The probability of target attainment (PTA) of the ratio of AUC24 (area under the concentration-time curve from 0 to 24 hours) and MIC (minimal inhibitory concentration) (AUC24/MIC) for various species of Candida spp isolates with a MIC range of 0.03 to 1.0 mg/L | 1 day | 
| The PTAs of trough concentration | PTA of patients with CAS trough concentration ≥ 1 μg/mL | the trough concentration (24 hours after administration) at the steady state |
Thoracotomy Effects on Pulmonary Function Test and Chest Expansion

Study Overview
=================
Brief Summary
-----------------
The purpose of the present study was to investigate the effect that corrective surgery for scoliosis would have on pulmonary function as well as the circumference of the chest. As a result, the current investigation was carried out on thirty individuals who had idiopathic scoliosis and had been admitted to the hospital. Before the surgery, after it had been completed (on the fifth day), and again three months later, the pulmonary function was tested.

Detailed Description
-----------------
The purpose of this study was to see how corrective scoliosis surgery affected pulmonary function and chest circumference. As a result, the current investigation was carried out on 30 individuals brought to the hospital with idiopathic scoliosis. The pulmonary function was assessed before surgery, on the fifth day following surgery, and three months thereafter.

Official Title
-----------------
Effects of Concave Thoracoplasty on Chest Circumference and Ventilatory Function in Adolescence With Idiopathic Scoliosis

Conditions
-----------------
Adolescent Idiopathic Scoliosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Adolescent idiopathic scoliosis Exclusion Criteria: smoking. Associated comorbidity that affects PFT. Any contraindication interfering with performing spirometry.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 18 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| intervention group<br>one group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| chest expansion | chest circumference meaurement | 10 months | 
| PFT | PULMONARY FUNCTION TEST Vital capacity (Liter). Forced VITAL Capacity (Liter). Maximal voluntary breathing (Liter). | 10 months for each parameter | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cobb angle | In terms of measuring the major curve Cobb's angle, patient in a standing posterior-anterior (PA) radiograph, the angle is composed of two intersecting lines: the upper endplate of the main thoracic curve upper vertebra and the lower endplate of the main curve lower vertebra. These lines meet at the point where the upper endplate of the main thoracic curve upper vertebra and the lower endplate of the main curve lower vertebra meet. | 10 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lung functions and thoracotomy
The Development of Quantitative Ultrasound Imaging Software Platform

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to compare the image differences between conventional ultrasound and artificial intelligence-based ultrasound software in conscious adults. The main question it aims to answer is to evaluate the effectiveness by determining that the new image analysis method is considered valid if it helps to identify more than 30% of histological characteristics. Participants will undergo the examination using the two methods mentioned earlier after signing the consent form.

Official Title
-----------------
The Development of Artificial Intelligence (AI) Based High Performance Structural-functional and Quantitative Ultrasound Imaging Software Platform

Conditions
-----------------
Chronic Liver Disease, Thyroid Disease, Benign Breast Disease, Malignant Breast Neoplasm, Acute Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: People with heart disease, thyroid disease, breast disease, and liver disease. Exclusion Criteria: Someone who has received surgery on the target organ in question.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Quantitative ultrasound information | Quantitative ultrasound images of heart, thyroid, and breast disease | 5 years |