linjc16/ctgov huggingface dataset:
Trial to Evaluate Safety, PD & PK of IV Study Drug, QN-302, in Pts w/ Advanced or Metastatic Solid Tumors

Study Overview
=================
Brief Summary
-----------------
Goal: learn about QN-302 in patients with solid tumors (metastatic, or advanced cancer). Main questions: What does the study drug do to human body (Pharmacodynamics [='PD']) What does the body do to study drug (how processed in body (Pharmacokinetics [='PK']) - Safety Study drug by intravenous infusion ('IV') once weekly for 3 weeks every 4-week 'cycle.' Study treatment continues as long as patient and their study doctor agree that study treatment is in the best interest of the patient.

Official Title
-----------------
A Phase I, Multicenter, Open-label, Dose Escalation and Dose Expansion Trial Evaluating the Safety, Pharmacodynamics, and Pharmacokinetics of Intravenous QN-302 in Patients With Advanced or Metastatic Solid Tumors

Conditions
-----------------
Solid Tumor

Intervention / Treatment
-----------------
* Drug: QN-302


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with histologically confirmed locally advanced or metastatic solid carcinomas, who have had tumor progression after receiving all standard of care therapies or for which there is no approved therapy 2. Evaluable or measurable disease by RECIST 1.1 Exclusion Criteria: -

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Dose escalation, Dose expansion
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cohort 1<br>Starting dose in dose escalation | Drug: QN-302<br>* dose escalation/dose expansion<br>* Other names: dose escalation cohorts;|
| Other: Cohort 2<br>2nd cohort in dose escalation | Drug: QN-302<br>* dose escalation/dose expansion<br>* Other names: dose escalation cohorts;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine MTD | maximum tolerated dose identified from dose escalation cohorts | 18 months | 
| Establish RP2D | recommended Phase 2 dose identified from dose escalation cohorts | 24 months |
Evaluation of Anterior Cruciate Ligament Tears Using Diffusion Tractography

Study Overview
=================
Brief Summary
-----------------
Knees injuries commonly affect the ACL. French current methodology is based on MRI focused on the knee with morphological sequences (T1, DP fat sat) allowing the study of ACL as follows: No lesion / Partial tear / Complete tear. The treatment (kinesitherapy, surgery, no intervention) is defined taking into account several factors such as age, knee laxity, physical activity and outcome of the radiology analysis (partial or complete tear). However, if the classification is straightforward in case of complete tear, it is not possible to establish a quantitative impact on the ACL in case of partial tear. As a consequence, the investigators will analyze the anisotropy coefficient with diffusion tractography. Any patient who undergo a posttraumatic knee MRI at the CHU Amiens Picardie will have an appointment at the 3T Signa MRI that has the knee-centric diffusion tractography sequence.

Official Title
-----------------
Evaluation of Anterior Cruciate Ligament Tears Using Diffusion Tractography

Conditions
-----------------
ACL Injury, MRI, Tractography

Intervention / Treatment
-----------------
* Other: tractography MRI sequence protocol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years old, Patient referred for non-enhanced knee MRI for traumatism. Affiliation to a social security program, Exclusion Criteria: Person under guardianship or curators, Any contraindications to MRI

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: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: tractography MRI sequence protocol|tractography MRI sequence protocol does not require injection of contrast agent.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anisotropy score after tractography MRI sequence | Anisotropy coefficient value is between 0 (isotropic medium) to 1 (fibrillar medium) . Anisotropy coefficient =0 is for total ACL rupture Anisotropy coefficient between 0 end 0.8 is for partial ACL rupture | one day | 
| Correlation between anisotropy coefficient and ACL lesion state | Anisotropy coefficient value is between 0 (isotropic medium) to 1 (fibrillar medium) . Anisotropy coefficient =0 is for total ACL rupture ACL lesion state are No lesion, Partial tear or Complete tear | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ACL Injury, MRI, tractography
Use of ıntegrated Pulmonary Index Monitorisation in Children Undergoing Botulinum Toxin Injection

Study Overview
=================
Brief Summary
-----------------
This study aimed to detect hypoxia early with ıntegrated pulmonary index monitoring compared to saturation.

Detailed Description
-----------------
This trial will be held at the kocaeli Universty Hospital. 75 children 4-17 years of age undergoing botulinum toxin injection with sedation will be enrolled in this prospective study. Patients premedicated with midasolam iv 0.5 mg bolus and then sedated with propofol 1 mg/kg and fentanyl 0.5 mg/kg . Integrated pulmonary monitoring and noninvasive capnograhy will be used. Bis monitoring and spo2 monitoring will be applied. standard anesthesia monitoring including noninvasive blood pressure, spo2 , ekg and heart rate will be monitored. This trial aimed to detect hypoxia and apnea earlier than pulse oximetry.

Official Title
-----------------
Effect of ıntegrated Pulmonary Index on Hypoxia

Conditions
-----------------
Cerebral Palsy, Pediatric ALL

Intervention / Treatment
-----------------
* Device: integrated pulmonary index
* Device: saturation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 4-16 age pediatrics undergoing botilinum injection with sedation asa 1-2 Exclusion Criteria: > 18 age asa 3-4 patients with upper respiratory tract infection

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 16 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: integrated pulmonary index hypoxia -capnogarph<br>integrated pulmonary index montorization apliied | Device: integrated pulmonary index<br>* integarted pumobary index monitoring<br>|
| Experimental: saturation - apnea<br>saturation apllied | Device: saturation<br>* saturation monitorization<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hypoxia | desaturation spo2 below 90 | 20 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| apnea - ıntegrated pulmonary index | no respiration ıntegrated pulmonary index under 4 | 20 seconds | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
botilinum toxin, pediatrics, ıntegrated pulmonary index, hypoxia
Translational Cancer Observational Protocol

Study Overview
=================
Brief Summary
-----------------
Observational study on relapse occurrence and on the quality of life in patients who underwent nephroureterectomy surgery

Detailed Description
-----------------
Monocentric prospective and retrospective observational study on the quality of life and on the pathological status in patients who underwent nephroureterectomy surgery. Oncological, psychological, sexual and quality of life-related data will be collected within a specifically created database that will allow us an easy and secure data extraction for the statistical analysis required by the clinical trial in terms of oncological relapse, clinical progression and improve the assistance and therapeutic strategy for each patient. Retrospective data for patients who underwent surgery between 1987 and today will be available in the form of clinical report stored in the hospital archives.

Official Title
-----------------
2014 Transizionali - Observational Study on the Occurrence of Relapses and on the Quality of Life in Patients Who Underwent Nephroureterectomy Surgery

Conditions
-----------------
Upper Urinary Tract Urothelial Carcinoma

Intervention / Treatment
-----------------
* Procedure: Nephroureterectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Upper tract urothelial cancer diagnosis Indication to cancer removal through nephroureterectomy surgery Ability to read and sign the informed consent Exclusion Criteria: Age < 18 years Absence of upper tract urothelial cancer Inability to read and sign the informed consent

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 |
| --- | --- |
| Experimental<br>Patients with upper urinary tract urothelial cancer who underwent nephroureterectomy surgery | Procedure: Nephroureterectomy<br>* Removal of cancer mass by urether and kidney complete resection.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical progression data collection | Collection intended for the purpose of implementing diagnostic and therepautic strategies for the management of the disease in both the patient enrolled in the study and for future cases. Data will be collected in a dedicated internal database by means of medical records obtained during the patients' stay in the hospital and during follow up visits. The data collected includes anamnesis, data regarding surgery, laboratory exam and imaging exams. | 50 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Upper Urinary Tract Urothelial Carcinoma, Nephroureterectomy surgery, Relapse, Quality of life, Diagnosis and Treatment strategies
OCT and OCT-A Deep Learning in Diabetic Patients Wiht Artificial Pancreas Device

Study Overview
=================
Brief Summary
-----------------
This study evaluates the ability of deep learning to improve the knowledge about structural and vascular retinal changes in diabetic patients undergoing artificial pancreas device, using optical coherence tomography angiography.

Detailed Description
-----------------
hybrid artificial pancreas systems (CSII) are able to adjust the type 1 diabetic patient's glycemic levels with insulin doses appropriate to the patient's blood glucose. The optical coherence tomography angiography represents a novel and noninvasive diagnostic technique that allows a detailed and quantitative analysis of retinal and choriocapillary vascular features. The study evaluates the changes in optical coherence tomography angiography features in diabetic patients undergoing artificial pancreas device, elaborating these data with artificial intelligence.

Official Title
-----------------
Deep Learning in Vascular and Structural Retinal Changes in Diabetic Patients Undergoing Artificial Pancreas Device

Conditions
-----------------
Type 1 Diabetes Mellitus With Artificial Pancreas Device

Intervention / Treatment
-----------------
* Device: hybrid artificial pancreas systems (CSII)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • age older than 18 years diagnosis of type 1 diabetes treatment with artificial pancreas device absence of previous ocular surgery and congenital eye diseases. absence of errors of refraction absence of lens opacities absence of low-quality OCT and OCTA images Exclusion Criteria: age younger than 18 years previous ocular surgery and congenital eye diseases errors of refraction lens opacities low-quality OCT and OCTA images

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| rype 1 diabetc patients with artificial pancreas device<br> | Device: hybrid artificial pancreas systems (CSII)<br>* artificial device that adjust the patient's glycemic levels with insulin doses appropriate to the patient's blood glucose<br>|
| healthy patients matched age and sex without diabetes and ocular disease<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The measurements of retinal and choriocapillary vessel density in type 1 diabetic patients undergoing artificial pancreas device | The parameters analyzed by optical coherence tomography angiography were: retinal and choriocapillary vessel density matched with clinical parameters resulted from the artificial pancreas device | up to 3months |
Transcriptomics and Epigenetics Analysis in Drug-Resistance of Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
Multiple Myeloma (MM) is the more common hematological neoplastic disease second only to Hodgkin lymphoma. In MM patients, mutated genes are mainly KRAS (23%), NRAS (20%), FAM46C (11%), DIS3 (11%) e TP53 (8%). Epigenetics studies suggested that Changes in histone modifications and DNA methylation pattern, as well as non-coding RNAs (miRNAs) expression are involved in MM development. In particular, it has been shown that the aberrant expression of different miRNAs could discriminate healthy from ill patients. Unfortunately, the main critical issue for an effective treatment of MM is the intrinsic or acquired resistance to pharmacological treatments, due also to a plasmacellular clonal heterogeneity. The prospective study will involve a patient cohort with MGUS, MM smouldering and MM, with the aim to characterize different transcriptional and epigenetic features, also including miRNAs, among MM cells susceptible or resistant to conventional therapies. The final goal is to identify new prognostic and predictive biomarkers that could be used as therapeutic tools to improve clinical targeted therapies.

Official Title
-----------------
Transcriptomics and Epigenetics Analysis for Biomarkers Identification Involved in Drug-resistance Mechanisms of Multiple Myeloma

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Other: ChIP-seq, NGS, ATAC-seq


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Compare Transcriptomics and epigenetic profile Exclusion Criteria: No exclusion criteria
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MGUS<br> | Other: ChIP-seq, NGS, ATAC-seq<br>* Bone narrow sampling<br>|
| MM smouldering<br> | Other: ChIP-seq, NGS, ATAC-seq<br>* Bone narrow sampling<br>|
| Syntomatic MM<br> | Other: ChIP-seq, NGS, ATAC-seq<br>* Bone narrow sampling<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transcriptomics variations in treated and non-treated MGUS, MM smouldering and syntomatic MM samples | Characterize genetic/epigenetic profile of cells resistant to the treatment sampled from MM patients before and after treatement. | 12 months | 
| Epigenetics variations in treated and non-treated MGUS, MM smouldering and syntomatic MM samples | Quantify genetic/epigenetic profile of cells resistant to the treatment sampled from MM patients before and after treatement. | 12 months |
Current Practice for Management of Pneumothorax in Egypt

Study Overview
=================
Brief Summary
-----------------
There are standard well-known guidelines for pneumothorax management with minimal difference between societies and associations. We are investigating how much of these guidelines are actually being followed in different healthcare facilites in Egypt. This is a questionnaire that will be sent to all healthcare givers in Egypt acorss different cities and facilities with multiple choice questions presenting different case scenarios and the management options being given to the patient.

Official Title
-----------------
Current Practice for Management of Pneumothorax in Egypt

Conditions
-----------------
Pneumothorax

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: being health care giver concerned with management of pneumothorax Exclusion Criteria: being not concerned with management of pneumothorax

Ages Eligible for Study
-----------------
Minimum Age: 1 Week
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Questionnaire|Questionnaire|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Management of pneumothorax | Mutiole choices question to choose from | 1 month |
Changes in the Upper Airway Volume After Rapid Maxillary Expansion in Adults Using Pure Skeletal Anchorage

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the effect of bone-anchored rapid maxillary expansion (RME) in the volume of the right maxillary sinus, left maxillary sinus and nasal and maxillary sinus airway complex, through bone anchored maxillary expansion devices (BAME); in addition, the influence of gender and age in the volume changes will be also analyzed. Material and method: 18 patients between undergone RME treatment with a jackscrew based on 4 miniscrews which will be placed in the palate on both sides of the midpalatal suture. Cone-beam computed tomography (CBCT) scans will be taken before and after suture palatine expansion and datasets will be uploaded into therapeutic digital planning software to measure the volume (mm3) of the right maxillary sinus, left maxillary sinus (mm3) and nasal and maxillary sinus airway complex (mm3). The airway volumes will be isolated after selecting the anatomical area in the axial, coronal and sagittal space plane and ensuring the air density measurement by reference points placement inside the selected area. Statistical analysis between preoperative and postoperative measurements will be performed using the statistical analysis of the t-test.

Official Title
-----------------
Changes in the Upper Airway Volume After Rapid Maxillary Expansion in Adults Using Pure Skeletal Anchorage

Conditions
-----------------
Orthodontic Appliance Complication, Dental Malocclusion, Bone Anchored Rapid Maxillary Expansion, Maxillary Hypoplasia, BAME

Intervention / Treatment
-----------------
* Procedure: Rapid Maxillary Expansion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients no history of systemic conditions that could interfere in bone metabolism and in the surgical process of orthodontic mini-implant placement radiographic imaging (CBCT KAVO OP3D Pro FOV 13X15cm) of maxillary discrepancy of more than 3mm compared with the ideal dimensions according to their mandible Exclusion Criteria: Age more than 31 years old Systematic conditions that interfere in bone metabolism

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 31 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Rapid Maxillary Expansion|Rapid Maxillary Expansion consists in the mid palatal suture opening through temporary anchorage mini implants placed in the palatal area.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The paired t-test analysis will show any statistically significant differences between the preoperative and postoperative volumes of the nasal and maxillary sinus airway complex |  | 2 months after bone anchored maxillary expansion is completed |
Patient Monitoring in the Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
a cross-sectional survey of nurses' perception of patient monitoring in the ICUs

Official Title
-----------------
Nurses' Perceptions of Patient Monitoring in the Intensive Care Unit: a Cross-sectional Study

Conditions
-----------------
Medical Informatics, Intensive Care

Intervention / Treatment
-----------------
* Other: No intervention, questionnaire survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: registered nurses in the ICUs Exclusion Criteria: -

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 |
| --- |
|Other: No intervention, questionnaire survey|No intervention, questionnaire survey|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical requirements of patient monitoring in ICUs | Assessed using a web-based 36-item survey questionnaire Patient Monitoring in the Intensive Care Unit | 12 months of working | 
| Work-related flow in ICUs | Assessed using the Work-related Flow inventory (WOLF) | 12 months of working |