linjc16/ctgov huggingface dataset:
Identification of Gene and Protein Markers of Kidney Injury in Aminoglycoside-treated Children

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are to identify potential gene and protein markers of aminoglycoside-induced kidney injury in infants, children and adolescents treated with aminoglycoside antibiotics.

Official Title
-----------------
Assessment of Gene and Urinary Protein Expression in Aminoglycoside-treated and Untreated Infants, Children and Adolescents

Conditions
-----------------
Infection, Renal Dysfunction

Intervention / Treatment
-----------------
* Drug: aminoglycoside


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (1) Hospitalized male and female newborns, infants, children and adolescents (ages birth to 18 years) with a diagnosis of suspected or proven bacterial sepsis, meningitis or other indication necessitating aminoglycoside therapy (2) hospitalized and outpatient newborns, infants, children and adolescents (ages birth to 18 years) who are not receiving aminoglycoside therapy. Exclusion Criteria: (1) Current treatment with inhaled or ophthalmic aminoglycosides (2) Prior treatment with an aminoglycoside within the last 30 days

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- |
| 1<br>Hospitalized, untreated infants and children | Drug: aminoglycoside<br>* Aminoglycosides will be administered and monitored as part of the routine standard of care for the subject.<br>|
| 2<br>Aminoglycoside treated infants and children without renal injury | Drug: aminoglycoside<br>* Aminoglycosides will be administered and monitored as part of the routine standard of care for the subject.<br>|
| 3<br>Aminoglycoside treated infants with renal injury | Drug: aminoglycoside<br>* Aminoglycosides will be administered and monitored as part of the routine standard of care for the subject.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Indicators of renal injury |  | Pre and post treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infection, renal dysfunction, aminoglycoside, protein, child
Gastric Cancer Surgery in Elderly Patients

Study Overview
=================
Brief Summary
-----------------
Gastric cancer is most frequent after the fifth decade of life. Surgical risk is higher in aged population because of general health condition may affect the postoperative result. Aim of the study was to identify risk factors for post-operative mortality in octogenarian patients who underwent surgery for gastric cancer.

Detailed Description
-----------------
236 patients (181: 80-85 years old and 55: >85 years old) underwent surgery for gastric cancer at the Sant'Orsola-Malpighi University Hospital in Bologna between 2010 and 2015. The variables of the two groups of patients were compared.

Official Title
-----------------
Post-Operative Outcomes And Predictors Of Mortality After Gastric Cancer Surgery In The Very Elderly Patients

Conditions
-----------------
Gastric Cancer

Intervention / Treatment
-----------------
* Procedure: Gastric resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with histologically confirmed primary gastric cancer submitted to surgical treatment; Age > 80 years. Exclusion Criteria: Patients with histologically confirmed primary gastric cancer submitted to surgical treatment and age < 80 years; Patients with histologically diagnosis of other neoplastic and non-neoplastic diseases submitted to surgical treatment.

Ages Eligible for Study
-----------------
Minimum Age: 80 Years
Maximum Age: 90 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 |
| --- | --- |
| Age; timing of gastric resection<br>Patients 80-85 years; Patients > 85 years; Elective and urgent surgery. | Procedure: Gastric resection<br>* Partial gastrectomy with jejunal anastomosis, total gastrectomy, gastroenterostomy without gastrectomy or other (palliative surgery).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative mortality In-hospital mortality was defined that occurred during hospitalization up to 90 days excluded post-operative mortality. Postoperative mortality | mortality occurred up to 90 days from surgery | Up to 90-days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Overall survival was defined as the time from the date of surgery to patient death (including surgery-associated death or hospital death), or the date of last available information concerning vital status. | Up to 5-years |
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ITI-214 in Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
This is a Phase I/II randomized, double-blind, placebo-controlled, multiple rising dose study in patients with stable idiopathic Parkinson's disease (PD) to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ITI-214.

Official Title
-----------------
A Randomized, Placebo-Controlled, Double-Blind Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of ITI-214 in Patients With Idiopathic Parkinson's Disease

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Drug: ITI-214
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Major Inclusion Criteria: Clinical diagnosis of idiopathic Parkinson's disease (PD) Severity of PD assessed by Hoehn and Yahr Staging score of 1 to 3 Maintenance on stable PD therapy Major Exclusion Criteria: Clinical signs of dementia Suicidal ideation or behavior Considered medically inappropriate for study participation

Ages Eligible for Study
-----------------
Minimum Age: 50 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
Interventional Model Description: Multiple rising dose in sequential cohorts of 8 patients randomized in a 6:2 ratio to receive ITI-214 or placebo
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 mg ITI-214<br>Administered once daily for 7 days | Drug: ITI-214<br>* Oral<br>|
| Experimental: 3 mg ITI-214<br>Administered once daily for 7 days | Drug: ITI-214<br>* Oral<br>|
| Experimental: 10 mg ITI-214<br>Administered once daily for 7 days | Drug: ITI-214<br>* Oral<br>|
| Experimental: 30 mg ITI-214<br>Administered once daily for 7 days | Drug: ITI-214<br>* Oral<br>|
| Experimental: 90 mg ITI-214<br>Administered once daily for 7 days | Drug: ITI-214<br>* Oral<br>|
| Placebo Comparator: Placebo<br>Administered once daily for 7 days | Other: Placebo<br>* Oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with reported or observed treatment-related adverse events | Safety and tolerability | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Concentration (Cmax) | Pharmacokinetics | 7 days | 
| Area of the Curve (AUC) | Pharmacokinetics | 7 days | 
| Motor and non-motor symptoms as assessed by the MDS-UPDRS | Pharmacodynamics | 7 days |
Medial Patellofemoral Ligament Reconstruction: A Review of Technique, Accuracy, and Outcome

Study Overview
=================
Brief Summary
-----------------
The purpose of this retrospective study was to determine the accuracy of femoral tunnel placement utilizing Redfern et al's radiographic method for anatomic femoral attachment during MPFL reconstruction in addition to the resultant outcome.

Detailed Description
-----------------
Reconstruction of the medial patellofemoral ligament (MPFL) has been shown to be an effective treatment for recurrent patellar instability, There has been some concern in the literature about the accuracy of femoral tunnel placement and the effect that it might have on patient outcomes. The investigators evaluated the accuracy of MPFL placement using an intraopetative fluoroscopy technique and to assess subsequent patient outcomes. All patients undergoing MPFL reconstruction using an intraoperative fluoroscopically guided technique between 2005 and 2010 were identified. A retrospective review of their charts and radiographs were performed and the subjects were brought back for a follow up exam, radiographic series, and Kujala questionaire.

Official Title
-----------------
Medial Patellofemoral Ligament Reconstruction: A Review of Technique, Accuracy, and Outcome

Conditions
-----------------
Healthy, Medial Patellofemoral Ligament Reconstruction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients having undergone the MPFL procedure, starting January 1, 2005 through February 3, 2010 Minimum follow up of 24 months Exclusion Criteria: Pregnant women Under 18 years of age Previously undergone prior MPFL surgery Participated in any previous research studies involving the use of ionizing radiation (either radioisotopes or diagnostic x-rays during the past 12 months. The participant should not volunteer for other research studies involving the use of ionizing radiation within 12 months of completing the current study.

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiograph measurements |  | 5 years |
In Vivo Optical Spectroscopy Monitoring in a New Model of Muscular Compartment Syndrome

Study Overview
=================
Brief Summary
-----------------
Muscular compartment syndrome (MCS) is consecutive to an increase in intramuscular compartment pressures, and is a rare but serious postoperative complication. The INVOS (In Vivo Optical Spectroscopy) monitors tissular oxygenation continuously and non-invasively. The objective is to develop a model mimicking the physiopathology of MCS to assess the interest of the INVOS in this case.

Detailed Description
-----------------
After inflation of a tourniquet (pressure equal to the mean arterial pressure, we will obtain a model of slight venous congestion and arterial hypoperfusion. A comparison will be made between INVOS monitoring, sensory deficits, pain, electromyography and invasive pressure.

Official Title
-----------------
In Vivo Optical Spectroscopy Monitoring in a New Model of Muscular Compartment Syndrome.

Conditions
-----------------
Human Volunteers

Intervention / Treatment
-----------------
* Device: Tourniquet
* Device: INVOS assessment
* Device: EMG assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers >18yr Informed consent Male Exclusion Criteria: Neuropathies Vascular pathology Actual pain Anti-platelet or anticoagulant therapy Ipsilateral history of fracture

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

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tourniquet<br>Inflation of a tourniquet | Device: Tourniquet<br>* Inflation of a tourniquet (pressure equal to the mean arterial pressure) obtaining a model of slight venous congestion and arterial hypoperfusion<br>Device: INVOS assessment<br>* Near Infraread spectroscopy, non invasive<br>Device: EMG assessment<br>* Electromyography, non invasive<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison Between INVOS Monitoring and Electromyography | A comparison will be made between the INVOS monitoring and non invasive (transcutaneous) EMG monitoring (AP Block), to determine the accuracy of the INVOS monitoring to predict AP block. Measures were: [mean (SD)] INVOS (in %) value at baseline and at the time of the block | 45 minutes | 
| Intracompartmental Pressure (ICP) | [mean (SD)] ICP (in mmHg), value at baseline and at the time of the block | 45 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Human volunteers
Using Decision Aids to Reducing Decision Conflict in Angiography Patients for Choosing Hemostasis

Study Overview
=================
Brief Summary
-----------------
Vascular closure device, hemostatic bandage and manual compression can achieve hemostasis after angiographic examination. These three methods of hemostasis changed the rate of hemostasis, early ambulation, hematoma , hemostasis failure rate, and expense. Therefore, shared decision making (SDM) is necessary to aid patients to choose hemostasis.The investigators have developed a decision aids (DA) and planned a randomized controlled trial (RCT) to evaluate its impact on angiographic patients. The measurements include a battery of interview-based questionnaires and evaluations of decision conflicts. The investigators expect the DAs would benefit the intervention group in the aspects of knowledge, communication and choice conflicts.during and after thier Hemostasis procedure.

Official Title
-----------------
Using Decision Aids to Reducing Decision Conflict in Angiography Patients for Choosing Hemostasis: A Randomized Controlled Trial

Conditions
-----------------
Haemostatic Adverse Reaction

Intervention / Treatment
-----------------
* Other: Decision aids


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who needs an angiographic examination or treatment. Patients with angiographic indications Patients who were able to give consent and complete the interview Exclusion Criteria: The angiographic procedure uses patients with a catheter size more than 7fr. Patients in critical situations requiring urgent treatment Patients had cognitive impairment Patients were physically unfit to be interviewed Patients were non-Mandarin or -Taiwanese

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DAs group<br>Shared decision making using decision aids | Other: Decision aids<br>* Shared decision making with decision aids<br>|
| No Intervention: Control group<br>Standard oral explanation guided with booklets | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decisional conflict | Total score of decisional conflict scale | 1 hour before Angiography | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Haemostasis
The Efficacy of HLX208 (BRAF V600E Inhibitor) for Refractory Primary Brain Tumors With BRAF Mutation After First-line Treatment

Study Overview
=================
Brief Summary
-----------------
An open-label, multicenter phase II clinical study to evaluate safety, efficacy and PK of HLX208 for refractory primary brain tumors with BRAF mutation

Official Title
-----------------
An Open-label, Multicenter Phase II Clinical Study to Evaluate Safety, Efficacy and PK of HLX208 for Refractory Primary Brain Tumors With BRAF Mutation

Conditions
-----------------
Brain Tumor, Primary

Intervention / Treatment
-----------------
* Drug: HLX208


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age>=18Y Good Organ Function Expected survival time ≥ 3 months Refractory primary brain tumors with BRAF mutation that have been diagnosed Unable to receive surgery/radiotherapy, or have treatment failed after surgery/radiotherapy ECOG score 0-1; Exclusion Criteria: Previous treatment with BRAF inhibitors or MEK inhibitors A history of other malignancies within two years, except for cured cervical carcinoma in situ, basal cell carcinoma of the skin, adenocarcinoma in situ of the lung, or tumors that do not require interventional treatment after radical surgery Severe active infections requiring systemic anti-infective therapy Other anti-tumor treatments, such as chemotherapy, targeted therapy, or radiation therapy (except palliative radiation therapy), may be given during the study period.

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HLX208<br> | Drug: HLX208<br>* 450mg bid po<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | Objective response rate(assessed by independent radiological review committee (IRRC) based on the RANO | from first dose to the last patient was followed up for 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression-free survival(PFS):assessed by IRRC and the investigator based on the RANO | from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier)，an average of about 1 year | 
| DOR | Duration of response | from the first occurrence of a documented CR or PR (whichever recorded earlier) to the time of first documented disease progression or death (whichever occurs first)，an average of about 1 year | 
| OS | Overall survival | from the first dose to the time of death due to any cause，an average of about 2 year |
Post-operative Imaging in High Grade Glioma: is Management Influenced?

Study Overview
=================
Brief Summary
-----------------
Magnetic resonance imaging (MRI) is likely to play an important role in the management of high grade glioma. Appropriate and timely neuroimaging in the follow up period is believed to be crucial in making subsequent management decisions. However, there is a paucity in the literature providing evidence to support this. The aim of this study is to determine whether neuroimaging performed at each component of the patient pathway after initial high grade glioma treatment, actually results in a real change in management (as opposed to a perceived change in management). The main emphasis is on all imaging used at the time of a MDM, however, we will also study specifically dynamic susceptibility contrast-enhanced (DSC) MRI and dynamic contrast enhanced (DCE) MRI. The study is in the format of Mock MDMs to be compatible with real life decision making. Using retrospective identical information available at the MDM i.e. compiled recent correspondence, histopathological and molecular information, the MDM members (oncology nurse, oncologist, neurosurgeon, neuroradiologist, pathologist/molecular scientist) will prospectively determine the patient management with and without the imaging.

Official Title
-----------------
Post-operative Imaging in High Grade Glioma: is Management Influenced?

Conditions
-----------------
Glioma

Intervention / Treatment
-----------------
* Other: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven HGG patients (Grade III and IV WHO criteria) Underwent surgery, radiotherapy and chemotherapy regimen according to 2018 NICE guidelines (1) >=18 years old Has follow-up MRI imaging (T1, T2, FLAIR and T1 with contrast enhancement) and also DSC and DCE imaging Evaluated at MDT meetings between March 2018 and March 2020. Exclusion Criteria: Patients who have insufficient clinical and radiological follow-up

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 |
| --- | --- |
| KCH patients<br>75 high grade glioma patients from KCH | Other: MRI<br>* Structural MR (T2, FLAIR, T1 and T1+C), DCE, DSC<br>|
| NHNN patients<br>75 high grade glioma patients from NHNN | Other: MRI<br>* Structural MR (T2, FLAIR, T1 and T1+C), DCE, DSC<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine how MR imaging influences the management of HGG patients |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine how advanced MR imaging influences the management of HGG patients |  | 12 months |