linjc16/ctgov huggingface dataset:
A Prospective Cohort Study of for Surgical Treatment of Irreducible Atlantoaxial Dislocation

Study Overview
=================
Brief Summary
-----------------
The management of irreducible atlantoaxial dislocation associated is challenging. Direct posterior distraction technique we proposed in 2010 could achieve satisfactory reduction. In 2020, we modified this technique and proposed a posterior intra-articular distraction technique. The intra-articular distraction technique could theoretically achieve satisfactory reduction and fusion. However, its superiority has not been proven. Therefore, we design a prospective study to compare the reduction rate and fusion rate of different strategies.

Official Title
-----------------
A Prospective Cohort Study of for Surgical Treatment of Irreducible Atlantoaxial Dislocation

Conditions
-----------------
Atlantoaxial Dislocation

Intervention / Treatment
-----------------
* Procedure: Posterior intra-articular distraction and fusion
* Procedure: Anterior transoral release and posterior cantilever reduction and fusion
* Procedure: TARP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CT indicated atlantoaxial dislocation Agree with the operation plan Agree to be followed up Exclusion Criteria: The pathology is traumatic or RA Underwent operations in occipital-cervical region before With mortal diseases Without ability to sign papers

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Irreducible Atlantoaxial Dislocation<br>Atlantoaxial dislocation which could not be reducted under anesthesia traction with 1/6 weight. | Procedure: Posterior intra-articular distraction and fusion<br>* Using reduction using posterior intra-articular distraction and fusion technique.<br>Procedure: Anterior transoral release and posterior cantilever reduction and fusion<br>* Using anterior transoral release and posterior cantilever reduction and fusion technique.<br>Procedure: TARP<br>* Using TARP technique.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fusion Rates | Atlantoaixal fusion rates | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Japanese Orthopaedic Association Scores | 0-17 Scores | 12 months | 
| Visual Analogue Scale | 0-10 Scores | 12 months | 
| Neck Disability Index | 0-5 Scores | 12 months |
The SPIRO-MOTE Study

Study Overview
=================
Brief Summary
-----------------
Multicentre Prospective Cohort Study of Remote Lung Function Testing in Children: validation and comparison of supervised and unsupervised spirometry

Official Title
-----------------
Multicentre Prospective Cohort Study of Remote Lung Function Testing in Children: Validation and Comparison of Supervised and Unsupervised Spirometry

Conditions
-----------------
Spirometry

Intervention / Treatment
-----------------
* Procedure: Spirometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female children aged 5 to 16 years old Doctor diagnosed respiratory condition, including asthma, cystic fibrosis, PCD, bronchiectasis Child able to perform reliable spirometry Family have access to a smartphone or tablet and a second device for video consultation Exclusion Criteria: Significant learning difficulties Other reasons for being unable to do lung function tests, for example, unable to make a seal around the mouthpiece Informed consent/assent has not been provided No English speaking member of the family Contraindications as outlined by the ARTP, e.g. pneumothorax, haemoptysis of unknown origin, unstable cardiovascular status, recent eye surgery, vomiting or any acute disease that would interfere with the test performance, recent surgery (thoracic/abdominal)

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 16 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Spirometry|Supervised v unsupervised spirometry|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome measures from spirometry tests (1) | The researchers will use the absolute values for FEV1 and FVC, coupled with the demographic data, to calculate FEV1/FVC, percent predicted and z-scores using a batch calculator from the GLI website. The team will record how many patients achieved technically acceptable tests, using the ATS A-F standards (9), and how many failed. | Within two weeks | 
| Outcome measures from spirometry tests (2) | The team will record how many patients achieved technically acceptable tests, using the ATS A-F standards (9), and how many failed. | Within two weeks | 
| Length of each standard test | Researchers will record how long each standard test took to carry out. | Within two weeks |
Safety Evaluation Study for Patients With Aggressive NK-cell Leukemia

Study Overview
=================
Brief Summary
-----------------
This is Phase I/II Dose-Escalation Study to evaluate the tolerability, safety, efficacy and pharmacokinetics of PPMX-T003 in aggressive NK-cell leukemia.

Official Title
-----------------
Multicenter, Open-label, Dose-escalation Phase I/II Study to Evaluate the Tolerability, Safety, Efficacy and Pharmacokinetics of Repeated Continuous Intravenous PPMX-T003 in Patients With Aggressive NK Cell Leukaemia (ANKL) (Physician-initiated Clinical Trial)

Conditions
-----------------
Aggressive NK Cell Leukemia

Intervention / Treatment
-----------------
* Drug: PPMX-T003


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with ANKL (regardless of whether the disease is first or recurrent) based on diagnostic criteria developed with reference to the World Health Organization (WHO) 4th edition (2017) criteria. Exclusion Criteria: Patients eligible to receive chemotherapy as treatment for ANKL

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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: Treatment with PPMX-T003<br> | Drug: PPMX-T003<br>* The therapeutic agent is administered continuously intravenously<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Experiencing Treatment-emergent Adverse Events (TEAEs) in the study |  | 35days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of improvement of liver lesions [by computed tomography (CT) scan] |  | 35 days | 
| Assessment of the serum drug concentration of PPMX-T003, calculate each PK parameters |  | 35 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neoplasms
Natural History of SMA

Study Overview
=================
Brief Summary
-----------------
This is an investigator initiated observational study with the aim to record several aspects of function, care and adverse events in a large cohort of SMA patients followed longitudinally by using a structured academic disease registry.

Detailed Description
-----------------
This is an observational multicenter retrospective and prospective study involving high quality data collected in 5 academic centers in Italy, the registry aims to better understand the natural history of the disease in untreated patients identifying factors that can influence disease progression by combining retrospective and prospective data. Describe the patterns of disease progression (in terms of functional measure, adverse events, levels of care, and hospitalization) in treated and untreated patients Identify all the patients treated with the available therapies in Italy, providing first line details on epidemiological data in a wider network including all centers recognized as centers for spinal muscular atrophy (SMA) in each region. As part of the activity clinical evaluators, data manager and sub-investigators are also trained and use common manuals of operation to ensure reliability across the participating centers. The registry provides accurate and reliable information on natural history including results from currently used functional measures. The registry also includes information on supportive care, hospitalization and adverse events. Details of the electronic clinical file record including data assembly and the platform used are available as part of a peer reviewed paper

Official Title
-----------------
Natural History of SMA: Long Term Longitudinal Study and Development of a Registry

Conditions
-----------------
Muscular Atrophy, Spinal

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients Exclusion Criteria: if enrolled in clinical trials
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 |
| --- | --- | --- |
| motor function | functional scales Hammersmith Functional motor scale, (minimum score 0, maximum score 74 indicating best performance | 15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| respiratory function | Forced Vital Capacity, need for ventilatory support | 15 years | 
| nutrition | need for nutritional support using Oral and Swallowing Abilities Tool (OrSAT) with a minimum score of 0 and a maximum score of 12 indicating best performance | 15 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
natural history, spinal muscular atrophy
Questionable Health Behaviors and Their Distal and Proximal Correlates

Study Overview
=================
Brief Summary
-----------------
The goals of the study: to investigate the frequency of Traditional, Complementary and Alternative Medicine use (TCAM) and intentional Non-adherence to medical recommendations (iNAR) in the general population in Serbia, as well as their mutual relations. to examine the distribution of irrational beliefs in the general population; to explore the relationships between TCAM and iNAR behaviors on the one hand and variables of personality, thinking styles and cognitive reflection on the other, with a major assumption that these relationships will be mediated by the domain of irrational beliefs and socio-political attitudes. Participants will respond to a battery of instruments assessing TCAM use and iNAR, as well as, sociodemographics and health-related variables (such as health status, chronic diseases, BMI, etc.), distal psychological (i.e. personality, thinking disposition and styles) and proximal psychological, variables, (i.e. the irrational mindset, as well as socio-political beliefs and attitudes). Data will be collected on the probabilistic household sample representative for the general population in Serbia (N=1043).

Official Title
-----------------
Questionable Health Behaviors and Their Distal and Proximal Correlates: Protocol for a Nationally Representative Survey in Serbia

Conditions
-----------------
Questionable Health Behaviors and Their Distal and Proximal Correlates

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: must be at least 18 years of age Exclusion Criteria: the inability to understand the Serbian language failure to pass any of the four attention-check questions

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 |
| --- | --- |
| General population<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Traditional, complementary and alternative medicine (TCAM) use | Prevalence of TCAM use | baseline | 
| intentional non-adherence to official medical recommendations (iNAR) | Prevalence of iNAR | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TCAM/ iNAR/ distal predictors /proximal predictors / irrational mindset
Barotrauma in Adults With Critical COVID-19

Study Overview
=================
Brief Summary
-----------------
During the pandemic of COVID-19, studies reporting a high incidence of barotrauma, both pneumothorax but also pneumomediastinum, in patients with critical COVID-19. If this is complications of the respiratory support used to treat patients hypoxemia or if it is a direct consequence of COVID-19 damaging the lung tissue is not known. The aim of this study is to investigate the incidence and type barotrauma, if there is an association between barotrauma and level of respiratory support used in the intensive care unit, and if barotrauma is associated with worse outcome compared to patients without barotrauma.

Official Title
-----------------
Barotrauma in Adults With Critical COVID-19

Conditions
-----------------
COVID-19, Barotrauma

Intervention / Treatment
-----------------
* Procedure: Open system
* Procedure: Non-invasive mechanical ventilation
* Procedure: Invasive mechanical ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Positive polymerase chain reaction for SARS-CoV-2 Admitted to ICU due to respiratory failure Exclusion Criteria: Transferred to or from an ICU in other hospital/region making data collection regarding baseline data/outcomes not possible

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Respiratory support by an open system<br> | Procedure: Open system<br>* Oxygen delivered on open system, for example high flow nasal cannula or low flow oxygen by nasal cannula or face mask<br>|
| Respiratory support by non-invasive mechanical ventilation<br> | Procedure: Non-invasive mechanical ventilation<br>* Respiratory support by for example continues or bilevel positive airway pressure<br>|
| Respiratory support by invasive mechanical ventilation<br> | Procedure: Invasive mechanical ventilation<br>* Respiratory support delivered through endotracheal tube or tracheostomy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barotrauma | Pneumothorax, pneumomediastinum, pneumatocele or subcutaneous emphysema as verified by radiology | 28 days from ICU admission |
Salvage Treatment With Glofitamab in R/R B-NHL: a GIMEMA-FIL Study

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to evaluate the anti-lymphoma activity of glofitamab, administered according to the Compassionate Use Program, in relapsed/refractory B-NHL patients. The main question it aims to answer is the rate of patients in complete response.

Detailed Description
-----------------
This is an observational multicenter study aimed at assessing the anti-lymphoma activity of glofitamab in relapsed/refractory B cell non-Hodgikin lymphoma patients treated according to the Compassionate Use Program in Italy between March 2022 and September 2023. Patients will be observed for a minimum of 12 months after the last glofitamab administration.

Official Title
-----------------
Salvage Treatment With Glofitamab in Patients Affected by Relapsed/Refractory Non-Hodgkin B-cell Lymphoma: a GIMEMA-FIL Study

Conditions
-----------------
B-cell Non Hodgkin Lymphoma, Relapse, Refractory Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who received glofitamab according to Compassionate Use Program AG42296 Age > 18 years Patients who received at least one dose of glofitamab between March 2022 and September 2023 in the context of the compassionate use program and who completed at least 1 year of observation after last glofitamab administration unless the patient died or was lost to follow up Patients who provided their consent according to local regulation to collect their data for study purposes, dead patients or patients lost to follow up for which any attempt has been made to collect their consent, according to local regulation on data privacy Exclusion Criteria: None

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients in complete response | Effectiveness of glofitamab in terms of complete response | 6 months |
The Effect of Biomarkers of Inflammation on Graft Function in Kidney Transplantation

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to investigate the relationship of inflammation markers with postoperative graft function and mortality in patients undergoing kidney transplantation.

Official Title
-----------------
The Effect of Biomarkers of Inflammation on Graft Function

Conditions
-----------------
Renal Transplant Failure and Rejection, Inflammation

Intervention / Treatment
-----------------
* Diagnostic Test: graft function


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients underwent renal transplantation Exclusion Criteria: patient refusal

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- |
| ınflammation<br> | Diagnostic Test: graft function<br>* renal transplantation<br>|
| non inflammation<br> | Diagnostic Test: graft function<br>* renal transplantation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RDW | Red Cell Distribution Width | baseline | 
| PNI | prognostic nutrition index (PNI) calculated as 10 × serum albumin (g/dl) + 0.005 × total lymphocyte count (per mm3) | baseline | 
| De Ritis | De Ritis described the ratio between the serum levels of aspartate transaminase (AST) and alanine transaminase (ALT) | baseline | 
| graft function |  | through study completion, an average of 1 year |
A Multicenter Observational Cohort of Degenerative Spine Diseases in China（DSDC）

Study Overview
=================
Brief Summary
-----------------
Study type: The objectives of this observational study were to understand, analyze, and compare the treatment and prognosis of patients with degenerative spine diseases and to construct a risk warning model and an assisted decision-making system The main questions it aims to answer are: [question 1] to construct a database of patients with degenerative spinal diseases and to study their associated prognosis, complications, and other risks [Question 2] Use big data to build a risk early warning model and assisted decision making system The study will not intervene with patients

Official Title
-----------------
A Multicenter Observational Cohort of Degenerative Spine Diseases in China

Conditions
-----------------
Degenerative Spine Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: patients with degenerative spine disease admitted to the units participating in the study from January 2015 to mid-January 2022; complete patient data with no more than 5% missing; Exclusion Criteria: Patients with oncology;
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 |
| --- | --- | --- |
| Collect demographics (Hospital Information System) | Collect demographics from the HIS system for patients with degenerative spine disease | 2022.03 |