linjc16/ctgov huggingface dataset:
Autologous Cellular Therapy With PRP-PC in Chronic Lung Diseases: An Observational Study LI-004

Study Overview
=================
Brief Summary
-----------------
For this study, cells will be harvested from the patient from the peripheral blood, isolated and concentrated using proprietary Emcyte™ equipment/centrifugation, and then returned to the patient same day via the peripheral circulation. As circulation occurs, the concentrated cells enter the right heart and are then disseminated into the lungs, becoming trapped in the lung's microcirculation. Here, the cells are believed to produce multiple bioactive factors such as cytokines and anti-inflammatory mediators. Several growth factors are released by activated platelets becoming honing cells for healing within the tissue. The exact long-term mechanism of action of PRP-PC in the lungs remains under investigation. Safety studies have proven that autologous treatment is incredibly safe, largely because of the minimal cell manipulation and the autologous nature of the cells. Prior observational studies in this are have shown strong safety profiles as well as strong efficacy in both COPD and ILD.

Detailed Description
-----------------
Study Objective(s) Primary To determine if pulmonary function improves following ceullar therapy Secondary To determine if participants' perceived quality of life related to breathing improves following cellular therapy To evaluate the safety of autologous PRP-PC administration for chronic lung disease

Official Title
-----------------
Autologous Cellular Therapy With PRP-PC in Chronic Lung Diseases: An Observational Study LI-004

Conditions
-----------------
COPD ILD

Intervention / Treatment
-----------------
* Biological: Autologous Cellular Therapy with PRP-PC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects age 18 and older Diagnosis of COPD or an interstitial lung disease Exclusion Criteria: Pregnant subjects, subjects with an active cancer diagnosis except for basal cell skin cancer-

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 |
| --- |
|Biological: Autologous Cellular Therapy with PRP-PC|In this study, cells will be harvested from the patient from the peripheral blood, isolated and concentrated using centrifugation, then returned to the patient same day via the peripheral circulation.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary Lung Function | Lung function will be measured with spirometry to test FVC volume, FVC % predicted, FEV1 volume, and FEV1% predicted. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life subjective | Quality of life will be measured with the Clinical COPD Questionnaire (CCQ). | 3 and 12 months |
Safety and Efficacy of the CryoCor™ Cardiac Cryoablation System for the Treatment of Atrial Flutter

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of right atrial intra-cardiac lesions created by transvenous catheter cryoablation in patients with atrial flutter.

Detailed Description
-----------------
Catheter ablation of arrhythmias has become an accepted alternative to pharmacologic therapy. Cryoablation is a newer alternative to radiofrequency ablations. This study expands the prior pilot experience with the CryoCor™ Cardiac Cryoablation System to a larger cohort of patients with atrial flutter.

Official Title
-----------------
Clinical Study to Evaluate the Safety and Efficacy of the CryoCor™ Cardiac Cryoablation System for the Treatment of Cavo-Tricuspid Valve Isthmus-Dependent Atrial Flutter

Conditions
-----------------
Atrial Flutter

Intervention / Treatment
-----------------
* Device: Catheter-based cardiac cryoablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic atrial flutter Exclusion Criteria: Prior ablation Contraindication to intervention Poor general health

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Catheter-based cardiac cryoablation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute efficacy |  |  | 
| Acute safety |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term efficacy |  |  | 
| Long-term safety |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atrial flutter, cryoablation
Comparison of Day-time and Night-time Operations of Supracondylar Humeral Fractures

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate that performing supracondylar humerus fracture operations during daylight hours may have better results than performing them at night.

Detailed Description
-----------------
Supracondylar humerus fractures are one of the most common traumatic fractures seen in children and their treatment usually requires immediate closed reduction and percutaneous pinning (CRPP). The presence of neurovascular complications associated with this fracture is considered an orthopedic emergency. For this reason, depending on the patient's operation time, the procedure should be performed at night under emergency conditions. Sleep deprivation, which is common in healthcare professionals, may affect patient safety due to disruptions in treatments and surgical procedures by reducing physician performance.

Official Title
-----------------
Comparison of Night-time and Daytime Operation on Outcomes of Supracondylar Humeral Fractures: A Prospective Observational Sudy

Conditions
-----------------
Supracondylar Fracture, Morbidity

Intervention / Treatment
-----------------
* Procedure: Closed reduction and percutaneous pinning (CRPP)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 5 to 12 years had supracondylar humeral fractures, underwent CRPP under general anaesthesia American Society of Anesthesiologists (ASA) physical status I to III Exclusion Criteria: Surgical procedures outside the operating room parental refusing the study protocol

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 12 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 |
| --- | --- |
| Group Day<br>operated at 07:30 AM - 06:30 PM | Procedure: Closed reduction and percutaneous pinning (CRPP)<br>* Operated for supracondylar humeral fractures<br>|
| Group Night<br>operated at 06:30 PM - 07:30 AM | Procedure: Closed reduction and percutaneous pinning (CRPP)<br>* Operated for supracondylar humeral fractures<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity | 30 days morbidity | one month | 
| Operation duration | time between anesthesia induction and anesthesia emergence | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | 30 days mortality | one month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
supracondyler humerus fracture, night time operation, sleep deprivation, closed reduction and percutaneous pinning, CRPP
Antimycotic Prophylaxis in Pediatric Patients Following Allogeneic Stem Cell Transplantation

Study Overview
=================
Brief Summary
-----------------
Pediatric patients are at high risk to acquire mycotic infections following allogeneic bone marrow transplantation. In the present retrospective analysis we assess the safety and efficacy of different regimens in antimycotic prophylaxis.

Official Title
-----------------
Safety, Feasibility and Efficacy of Caspofungin Versus Liposomal Amphotericin B as Antifungal Prophylaxis Following Allogeneic Hematopoietic Stem Cell Transplantation in Pediatric Patients - a Retrospective Phase I/II Study

Conditions
-----------------
Systemic Aspergillosis, Systemic Candidiasis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients under the age of 18 years Pediatric patients after HSCT treated with caspofungin Pediatric patients after HSCT treated with liposomal amphotericin Exclusion Criteria: Pediatric patients with uncontrolled hematological malignancies Pediatric patients with IFI at start of HSCT

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LAmb<br> | |
| Cas<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Logistic Regression of Risk Factor for the 5-year Mortality of Aortic Dissection

Study Overview
=================
Brief Summary
-----------------
The relevant predictive hospital risk factors for 5-year mortality of patients with aortic dissection is untill unlear. The aim of this study is to collect the clinical data of 111 hospitalized patients admitted to hospital from Aug. 2001 to Aug. 2007, and statistically analyze the hospital risk factors related to 5-year mortality by univariate and multivariate binary logistic regression.

Detailed Description
-----------------
Clinical data were collected from 111 hospitalized patients admitted to hospital from Aug. 2001 to Aug.2007, and the related factors for death within 5 years after the onset of dissection, which include Gender, age, history of smoking, hypertension, diabetes, renal insufficiency (azotemia), low admission diastolic blood pressure (<70mmHg), Stanford typing (Stanford A or B), long-acting calcium channel blocker treatment,ACEI /ARB treatment, endovascular stent and surgical aortic replacement,were statistically analyzed by univariate and multivariate binary logistic regression.

Official Title
-----------------
Logistic Regression of Risk Factor for the 5-year Mortality of Aortic Dissection

Conditions
-----------------
Aortic Dissection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stanford type A dissection Stanford type B dissection Exclusion Criteria:

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| aortic dissection<br>aortic dissection | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death after 5 years after the onset of dissection | participants have been followed for 5 years after the onset of dissection | 5 years |
Evaluate the Pharmacokinetics of Quetiapine Fumarate in Chinese Schizophrenic Patients

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to evaluate the pharmacokinetics of XR quetiapine fumarate(300mg,600mg,and 800mg once-daily) in Chinese schizophrenic patients .

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: quetiapine fumarate extended-release
* Drug: quetiapine fumarate extended-release


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women aged 18 through 60 years inclusive Schizophrenia diagnosis Body Mass Index (BMI) 20-27 kg/m2 (inclusive) Provision of written informed consent before initiation of any study Exclusion Criteria: AIDS & hepatitis B History of seizure disorder History of episodic,idiopathic orthostatic hypotension

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>quetiapine fumarate extended-release 300mg,administered once-daily Day1 5 | Drug: quetiapine fumarate extended-release<br>* 300mg,oral,single dose<br>* Other names: SEROQUEL XR;|
| Experimental: 2<br>quetiapine fumarate extended-release 300mg/Day1,600mg/Day2 6,administered once-daily | Drug: quetiapine fumarate extended-release<br>* 300mg,oral,single dose<br>* Other names: SEROQUEL XR;|
| Experimental: 3<br>quetiapine fumarate extended-release 300mg/Day1,600mg/Day2,800mg/Day3 7,administered once-daily | Drug: quetiapine fumarate extended-release<br>* 200mg,oral,single dose<br>* Other names: SEROQUEL XR;Drug: quetiapine fumarate extended-release<br>* 300mg,oral,single dose<br>* Other names: SEROQUEL XR;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| single dose PK parameters(300mg) |  | Day1 to 48 hour after Day 5 | 
| Steady-state multiple doses PK parameters |  | Day 1 to 48 hours after Day7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of AEs |  | sign ICF to Day 9 | 
| Clinical significant change in Lab test |  | baseline up to Day 9 | 
| Clinical significant change in vital signs |  | baseline up to Day 9 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
quetiapine fumarate(SEROQUEL) extended-release(XR) China PK Study, pharmacokinetics parameters
The Factors Predicting Change of Peritoneal Transport Characters in Peritoneal Dialysate

Study Overview
=================
Brief Summary
-----------------
Peritoneal fibrosis (PF) is one of the most serious complications after long-term continuous ambulatory peritoneal dialysis (CAPD). Human peritoneal fibroblast (HPFB) and extracellular matrix (ECM) deposition is the most possible causes leading to PF. ECM are mainly synthesized from HPFB and human peritoneal mesothelial cells (HPMC). In the PF process, there is decrement in the quantity of HPMC, loss of permeability for lower molecules, and eventually ultrafiltration failure. This phenomena will result in technique failure. High glucose content of the dialysate and peritonitis have been claimed as major stimulants to the development of PF. In each episode of peritonitis, the number of HPMC will decrease. On the other hand, ECM production will be reinforced by the inflammatory cytokines secreted by the white cells or HPMC per se. High glucose dialysate will induce the above process with more chronic stimulation, and PF followed by technique failure is inevitable. Peritoneal fibrosis is definitively diagnosed with peritoneal biopsy, but this is inconvenient for most patients. Besides, pathology changes will be noted only after a substantial loss of peritoneal function. The peritoneal equilibration test (PET) is usually used as the index of peritoneal function. However, in the chronic process, PET change is also slow and is unable to be a parameter for treatment outcome. In this study, the factors predicting PET change will be searched, and they could be an index for evaluation and even a marker of preventing or treating PF. In this project, peritoneal dialysis (PD) dialysate will be collected during an annual PET in each PD patient in the National Taiwan University Hospital (NTUH). Some cytokines that will be measured include vasculoendothelial growth factor, hyaluronan, transforming growth factor-β, procollagen, and cancer antigen-125. The same test and measurement will be performed during PET in the next year. The factors which affect PET results will be analyzed such as cytokines, glucose exposure, peritonitis incidence, PD duration, gender, age. The investigators will try to find a convenient acute reactive marker for preventing or treating PF to monitor the PET change clinically.

Conditions
-----------------
Peritoneal Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All PD patients Exclusion Criteria: Peritonitis

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peritoneal dialysis
Clinical Observation of Titration Induction and Convention Induction of Propofol

Study Overview
=================
Brief Summary
-----------------
As we know propofol is popular use in the anesthesia induction with kilogram and it always cause hypotension. So we compare haemodynamic changes and drug consumption between propofol titrated administration and traditional administration for anesthesia induction.

Detailed Description
-----------------
GroupⅠreceived propofol 2 mg/kg intravenously by Fresenius pump at the speed of 250 mg/min, GroupⅡreceived propofol intravenously by Fresenius pump at the speed of 1 mg/kg/min, and observe's assessment of alertness and sedation(OAA/S) scale of the patients was titrated to 1, then changed to a maintenance dose

Official Title
-----------------
Clinical Observation of Titration Induction and Convention Induction of Propofol

Conditions
-----------------
Propofol Overdose of Undetermined Intent

Intervention / Treatment
-----------------
* Procedure: titration induction to propofol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with American Society of Anesthesiologists(ASA)Ⅰor Ⅱ and aged 18-60 yr, who were scheduled for general anesthesia. Exclusion Criteria: Hypertension, Severe heart,pulmonary,brain，liver and renal dysfunction; excess obesity , predicted difficult intubation,hearing obstacles;. Allergic to propofol or its fat emulsion;addictive to sedative and other drugs.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: titration induction of propofol<br>titration induction of propofol by Fresenius pump at the speed of 1 mg•kg-1•min-1 | Procedure: titration induction to propofol<br>* propofol intravenously by Fresenius pump at the speed of 1 mg•kg-1•min-1, and OAA/S scale of the patients was titrated to 1<br>|
| No Intervention: convention induction of propofol<br>propofol 2mg•kg-1 intravenously by Fresenius pump at the speed of 250mg•min-1 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| systolic pressure diastolic pressure mean blood pressure | before propofol dosage ,1 min after the propofol dosage, 3 min , 5 min , endotracheal intubation done immediately,1 min,3 min,5 min,7 min,9 min after endotracheal intubation | 15minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total dosage of propofol using |  | 15 minutes |
Recurrent S. Aureus Infections in Osteoarticular Infections

Study Overview
=================
Brief Summary
-----------------
Staphylococcus aureus osteoarticular infections, in particular those associated with the presence of implant, relapse in 20% of cases. Currently, the reasons for these relapses are poorly understood, whether on the microbiological or clinical side. The aim of this study is to improve knowledge on persistence of mechanisms of S. aureus

Official Title
-----------------
Recurrent S. Aureus Infections in Osteoarticular Infections

Conditions
-----------------
Bone and Joint Infection, Staphylococcus Aureus Infection

Intervention / Treatment
-----------------
* Other: relapse due to S. aureus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients having had an osteoarticular infection with or without material due to S. aureus presenting a recurrence of S. aureus infection 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 |
| --- | --- |
| relapse due to S. aureus<br>patients having had an initial infection due to S. aureus and who present a relapse with persistence of S. aureus | Other: relapse due to S. aureus<br>* to find out if it is the same S. aureus in both infections<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of patients having had an osteoarticular infection due to S. aureus | proportion of patients having had an osteoarticular infection due to S. aureus | between 2015 and 2020 | 
| Description of patients having had an osteoarticular infection due to S. aureus | type of patients: age, BMI, comorbidities... | between 2015 and 2020 | 
| Description of Bone and Joint Iinfection/Prosthesis Joint Infection | implant or prosthesis or not, acute/ chronic, bacteriology | between 2015 and 2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of patients having had a relapse due to persistence of S. aureus | proportion of patients having had an osteoarticular infection due persistence of S. aureus | between 2015 and 2020 | 
| rate of S. aureus strain identical between the initial episode and the relapse | proportion of relapse due to the same strain of S. aureus than in the initial episode | between 2015 and 2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
relapse, Staphylococcus Aureus Infection, Bone and Joint Infection