linjc16/ctgov huggingface dataset:
Retrospective Study of Germ Cell Tumors of the Central Nervous System

Study Overview
=================
Brief Summary
-----------------
Retrospectively analyzing the epidemiological and clinical characteristics, treatment, recurrence, prognosis and prognostic factors of the germ-cell tumors of central nervous system in a single center.

Detailed Description
-----------------
Clinical data of patients with germ-cell tumors of central nervous system who were treated in the Department of Neuro-oncology, Sanbo Brain Hospital Capital Medical University between January 2007 and December 2022 were retrospectively collected, and the epidemiological and clinical characteristics, treatment, recurrence, prognosis and prognostic factors of the disease were analyzed.

Official Title
-----------------
Single-center Retrospective Study of Germ Cell Tumors of the Central Nervous System

Conditions
-----------------
Germ Cell Tumor of CNS

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinically or pathologically diagnosed as germ cell tumor of the central nervous system. Have received antitumor therapy. Patients who were clinically diagnosed based on neuroimaging characteristics and response to radiotherapy or chemotherapy were allowed for enrollment. Exclusion Criteria: Patients with missing key information such as tumor location, surgical, chemotherapy and radiotherapy data, and post-treatment evaluation.
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 |
| --- | --- | --- |
| epidemiological characteristics |  | 1 year | 
| treatment regimen |  | 1 year | 
| relapse pattern |  | 1 year | 
| prognostic factor |  | 1 year |
Analysis of Circulating Exosomes in Melanoma Patients

Study Overview
=================
Brief Summary
-----------------
The hypothesis is that PD-L1[Programmed Death-Ligand 1] labeling in exosomes could be a biomarker of disease progression in melanoma. The rate of circulating exosomes, their size and the exosomal expression of PD-L1 could be correlated with the stage of the disease, the response to treatment and/or the prognosis of patients. In this study, blood samples (EDTA tubes taken as part of routine care at Besançon University Hospital) and associated clinical data are reused.

Official Title
-----------------
Analysis of Circulating Exosomes in Melanoma Patients

Conditions
-----------------
Melanoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Melanoma patients admitted in Besançon University Hospital exigible for immunotherapy such as anti PD-L1/PD-1 Age ≥18 years Affiliation to a social security system, Exclusion Criteria: Minor patients Patients who have expressed their opposition to the reuse of their data and biological samples

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 |
| --- | --- | --- |
| Quantification of circulating exosomes | Dosage of proteic biomarkers in circulating exosomes, plasma and tumor tissues. Blood samples were taken in standard care, before initiation of immunotherapy and then during disease follow-up until progression and tumor evaluation | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PDL1 marking | Compare PD-L1 labeling in exosomes to PD-L1 labeling in plasma and in tumor tissue. Blood samples were taken in standard care, before initiation of immunotherapy and then during disease follow-up until progression and tumor evaluation | Day 1 | 
| Other proteins detection | Identify other proteins of interest in circulating exosomes. Blood samples were taken in standard care, before initiation of immunotherapy and then during disease follow-up until progression and tumor evaluation. | Day 1 | 
| Determine whether the initial exosome concentration (at T0) is associated with a response to treatment. | Dosage of PD-L1 in circulating exosomes. Blood samples were taken in standard care, before initiation of immunotherapy and then during disease follow-up until progression and tumor evaluation | Day 1 |
Investigating Participation Patterns Among Stage IV Melanoma Patients

Study Overview
=================
Brief Summary
-----------------
Clinical trials, specifically focused on stage IV melanoma, are crucial in assessing the safety and efficacy of new treatments for this disease. These trials serve as fundamental instruments in determining whether emerging medications outperform standard therapies, providing compelling evidence to support wider implementation. The main goal is to thoroughly scrutinize trial completion rates and voluntary withdrawals among this particular group of patients.

Official Title
-----------------
Understanding Patient Engagement Trends in Stage IV Melanoma Clinical Trials

Conditions
-----------------
Stage IV Melanoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged ≥ 18 years old Diagnosis of stage IV melanoma Able to comprehend the investigational nature of the protocol and provide informed consent Exclusion Criteria: Female patients who are currently pregnant or nursing Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. Inability to perform regular electronic reporting

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 stage IV melanoma patients who decide to enroll in a clinical research |  | 3 months | 
| Rate of stage IV melanoma patients who remain in clinical trial to trial completion |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stage IV Melanoma
Adherence and Persistence to Inclisiran Among Early Users in Germany

Study Overview
=================
Brief Summary
-----------------
The present study was a descriptive, non-interventional, retrospective cohort study aimed at evaluating early data on adherence, persistence, and treatment patterns among patients receiving inclisiran and other lipid-lowering therapies (LLT) in a real-world setting in Germany. Analysis was carried out using the IQVIA™ LRx database.

Official Title
-----------------
Adherence and Persistence to Inclisiran Among Early Users in Germany

Conditions
-----------------
High Levels of Low-density Lipoprotein Cholesterol

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Study subjects ≥18 years old who were prescribed an inclisiran dose. Exclusion Criteria: None

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 |
| --- | --- |
| Overall cohort<br>Patients receiving inclisiran | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and percentage of patients with at least 5 months of potential follow-up who were prescribed a second dose of inclisiran |  | 8 months | 
| Percentage of patients who were prescribed a second dose of inclisiran between 1 and 6 months after prescription of first dose |  | 8 months | 
| Median time between first and second prescribed doses |  | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age and gender characteristics |  | 6 months | 
| Age and gender distribution |  | 6 months | 
| Prescriber specialty distribution for patients |  | 6 months |
Correlation Between Myocardial Injury and Intestinal Flora Changes Associated With Oncology Drug Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to explore the relationship between early myocardial injury caused by tumor drug therapy and intestinal microbial structure changes by echocardiographic two-dimensional speckle tracking technique and intestinal microflora structure detection.

Detailed Description
-----------------
This is a monocentric prospective cohort study in which 50 patients treated for malignant tumors will be included. All participants will be followed for 6 months after the initiation of oncology drug therapy. Echocardiography and 2D speckle tracking will be performed and stool and blood samples will be tested before treatment initiation and at 3 and 6 months after initiation.

Official Title
-----------------
Correlation Between Early Myocardial Injury and Intestinal Flora Changes Associated With Oncology Drug Therapy

Conditions
-----------------
Cancer Therapy-related Cardiovascular Toxicity

Intervention / Treatment
-----------------
* Drug: Antitumor drugs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: With malignant tumors Will receive antitumor drugs Could receive regular follow-up for 6 months Written informed consent Exclusion Criteria: Satisfactory echocardiographic images could not be obtained Cardiomyopathy Coronary artery disease Heart failure Arrhythmia requiring intervention Moderate or severe valvular disease Acute myocarditis Refractory hypertension Participating in other studies of drug intervention

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients treated with antineoplastic agents<br>50 patients treated with antineoplastic agents will be enrolled. | Drug: Antitumor drugs<br>* Anthracyclines, immune checkpoint inhibitors, monoclonal antibodies, and tyrosine kinase inhibitors<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| At least a 10% decrease in the global longitudinal strain | The primary endpoint is at least a 10% decrease in the global longitudinal strain, determined using cardiac 2D STE and compared with baseline. | 6 months |
Head and Neck Paragangliomas: A 16-year Experience of a University Hospital in Turkey

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to examine the head and neck paraganglioma cases treated in Pamukkale University hospital between 2007-2023 and improve our understanding of these cases and contribute to the knowledge surrounding head and neck paragangliomas.

Detailed Description
-----------------
39 patients were selected and analyzed retrospectively. Demographic informations, complaints at the time of admission, radiological examinations, paraganglioma types, stages, postoperative complications, and relapsed cases were recorded.Preoperative staging plays a crucial role in surgical planning and predicting potential intraoperative complications. In such cases, combination therapy alongside surgery may improve treatment outcomes.

Official Title
-----------------
Head and Neck Paragangliomas: A 16-year Experience of a University Hospital in Turkey

Conditions
-----------------
Head and Neck Paraganglioma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histopathological diagnosis of carotid paraganglioma Histopathological diagnosis of vagal paraganglioma Histopathological diagnosis of jugular paraganglioma Histopathological diagnosis of tympanic paraganglioma Exclusion Criteria: -Inadequate information in files
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 |
| --- | --- | --- |
| Postoperative recurrence | Incidence of recurrences after the surgery | may 2023-june 2023 | 
| Postoperative nerve paralysis | Incidence of facial, vagus, hypoglossus, accesorius nerve paralysis after surgery | may 2023-june 2023 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Paraganglioma, glomus
Management of Combined Fracture Neck of Femur and Femoral Deformity in Osteogenesis Imperfecta Patient

Study Overview
=================
Brief Summary
-----------------
O.I with NOF fixed by Wagner technique and telescoping nail

Detailed Description
-----------------
osteogenesis imperfecta (Sillence Type IV) sustained neck of femur fracture after fall on ground. He had proximal femoral anterolateral bowing on top of inserted rod 4 years ago. He was treated with corrective osteotomy and intramedullary telescoping nail for deformed femur and Wagner technique to fix NOF fracture. One year after operation the patient gained satisfactory functional outcome with union of NOF fracture and correction of femoral deformity. This rare case illustrates the anticipated difficulties in managing neck of femur fracture in osteogenesis imperfect patients. The method of fixation with Wagner technique can achieve stable fixation for solid healing in fragility fractures like this and the least interference with telescoping nail insertion.

Official Title
-----------------
Management of Combined Fracture Neck of Femur and Femoral Deformity in Osteogenesis Imperfecta Patient

Conditions
-----------------
Osteogenesis Imperfecta

Intervention / Treatment
-----------------
* Procedure: corrective osteotomy and intramedullary telescoping nail for deformed femur and Wagner technique to fix NOF fracture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: OI Exclusion Criteria: Not receiving Bisphosphonate

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 14 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: fixation with Wagner technique
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fixation with Wagner technique and Telescoping nail<br>corrective osteotomy and intramedullary telescoping nail for deformed femur and Wagner technique to fix NOF fracture | Procedure: corrective osteotomy and intramedullary telescoping nail for deformed femur and Wagner technique to fix NOF fracture<br>* corrective osteotomy and intramedullary telescoping nail for deformed femur and Wagner technique to fix NOF fracture<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified McKay's criteria | hip function score | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteogenesis imperfecta, fracture neck of femur, telescoping nail
BACTERIUM: Study for a Machine-learning-based Model to Predict Bloodstream Infections

Study Overview
=================
Brief Summary
-----------------
An increase of healthcare-associated infections caused by multidrug- resistant organisms (MRDO) is currently observed. One of the main causes of the emergence of a MDRO infection is an overuse of antibiotics. Therefore, saving useless antibiotic treatment is currently a priority from a public health point of view. The evaluation of the risk of having a bloodstream infection will allow both activating faster treatment decisions (when the risk is significantly high) or to save useless resources in terms of diagnostic tests and treatments, also limiting the potential for side effects (when the risk is significantly low).

Official Title
-----------------
BACTERIUM: Study for a Machine-learning-based Model to Predict Bloodstream Infections

Conditions
-----------------
Infection, Bloodstream

Intervention / Treatment
-----------------
* Drug: antibiotic treatments


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients hospitalized at the Gemelli Polyclinic Foundation having at least one performed blood culture starting an antibiotic therapy Exclusion Criteria: blood cultures with contaminants <18 years old died after less than 48 hours from blood cultures positivity

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: antibiotic treatments|The outcome of the study will be to implement Prediction Models to support clinicians for the assessment of risk of having a bloodstream infection.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of appropriate antibiotic therapy in patients with bloodstream infections | 1) number of patients with bloodstream infections with appropriate antibiotic therapy before and after the application of the predictive model Bacterium | 24 months | 
| Blood cultures | number of blood cultures done before and after the application of the predictive model Bacterium | 24 months |
Human Umbilical Cord Blood Infusion in Patients With Acute Ischemic Stroke (AIS)

Study Overview
=================
Brief Summary
-----------------
A Phase II, Randomized, Double-blind, Parallel, Placebo-controlled Study to Assess the Safety and Efficacy of Human Umbilical Cord Blood Infusion in Patients with Acute Ischemic Stroke

Detailed Description
-----------------
This is a phase II study to evaluate the safety and efficacy in hUCB treatment on the patients with acute ischemic stroke (AIS).

Official Title
-----------------
A Phase II, Randomized, Double-blind, Parallel, Placebo-controlled Study to Assess the Safety and Efficacy of Human Umbilical Cord Blood Infusion in Patients With Acute Ischemic Stroke

Conditions
-----------------
Acute Ischemic Stroke

Intervention / Treatment
-----------------
* Biological: hUCB


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subject ≥18 and ≤80 years of age. Subject with a confirmed diagnosis of AIS and hemiplegia Exclusion Criteria: Subject with known immune disease, immunodeficiency, or receives immunosuppressive therapy/immunomodulators within 4 weeks or 5 half-lives prior to screening, whichever is longer.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A group: hUCB treatment<br>Human cord blood infusion | Biological: hUCB<br>* hUCB<br>|
| No Intervention: B group: Placebo treatment<br>Placebo infusion | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety-TEAE | Frequency and incidence of treatment-emergent adverse events (TEAEs). | From screening to 48 weeks |
Preoperative Carbohydrate Loading in Bariatric Surgery - Clinical Trial

Study Overview
=================
Brief Summary
-----------------
Insulin resistance is a key feature of postoperative metabolism, leading to decreased glucose absorption in adipose tissue and skeletal muscle, with an increased glucose release due to hepatic gluconeogenesis and hyperglycemia. Development of insulin resistance is associated with increased length of hospital stay (LOS), morbidity, and mortality. One of the strategies employed to reduce the postoperative stress response and perioperative insulin resistance includes the reduction of the preoperative fasting time via preoperative carbohydrate oral (CHO) drink. Preoperative carbohydrate intake is an integral part of the Enhanced Recovery After Surgery (ERAS) protocol and previous studies have shown that preoperative carbohydrate loading can increase patient comfort. Although ERAS protocols are increasingly used and implemented in bariatric surgery centres specific components of these protocols, such as preoperative oral carbohydrate nutrition, have not yet been rigorously analyzed. The aim of this prospective study is to compare the differences in patient outcomes between preoperative CHO loading and a conventional fasting protocol. The secondary aim is to perform a subgroup analysis of Roux-en-Y bypass and sleeve gastrectomy.

Official Title
-----------------
Preoperative Carbohydrate Loading in Bariatric Surgery - Clinical Trial

Conditions
-----------------
Bariatric Surgery, Carbohydrate Loading

Intervention / Treatment
-----------------
* Dietary Supplement: Preoperative carbohydrate drink


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who will undergo surgery at the Elective Surgery Clinic of the University Clinical Centre in Gdansk, Poland. Exclusion Criteria: Patients who will be unable or will refuse to express informed concern
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preoperative carbohydrate loaded patients<br> | Dietary Supplement: Preoperative carbohydrate drink<br>* Allocation will be performed using an alternating weeks scheme. Patients undergoing surgery in the first week will be included in the control group and follow a conventional fasting protocol. However, patients undergoing surgery the following week will be included in the intervention group and take 800 ml of CHO drink on the day before surgery and 400 ml on the surgery day no later than 6 hours before the procedure.<br>|
| No Intervention: Conventional fasting protocol<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose level |  | 10 days |