linjc16/ctgov huggingface dataset:
Immune Modulation by Exosomes in COVID-19

Study Overview
=================
Brief Summary
-----------------
Following whole blood stimulation with mesenchymal stem cell derived exosomes, immune phenotype, cytokine release and mRNA expression patterns from critically ill patients with COVID-19 will be determined.

Detailed Description
-----------------
Critically ill patients with COVID-19 may develop lung failure and require extracorporal oxygenation due to hyperinflammation and progressive lung fibrosis. The anti-inflammatory and immune modulatory function of mesenchymal stem cells will be investigated by whole blood stimulation experiments using stem cell derived exosomes. Exosome preparations have been characterized by miRNA and protein expression patterns and suggest their tissue regenerative capacity. The hypothesis of the present study is that mesenchymal stem cell derived exosomes attenuate inflammation and support anti-fibrotic pathways.

Official Title
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Immune Modulation by Stem Cell Derived Exosomes in Critically Ill COVID-19

Conditions
-----------------
Lung Fibrosis, COVID-19, Critical Illness, Hypercytokinemia

Intervention / Treatment
-----------------
* Biological: Application of exosomes in a whole blood assay


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Critically ill COVID-19 patients with lung dysfunction COVID-19 WHO severity degree >= 4, ARDS (WHO Definition 13 March 2020) Body weight > 50 kg Informed consent Exclusion Criteria: Pregnant or breast feeding women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Application of exosomes in a whole blood assay|Co-incubation of patient-derived whole blood samples with mesenchymal stem cell derived exosomes and read-out of biomarkers, RNA and immune phenotypes after 24h.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytokine profile in supernatants | Quantification of pro- and anti-inflammatory biomarkers after 24 hours of whole blood culture | 24 hours, 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immune phenotyping | Immune phenotypes related to type I interferon signaling | 1 year | 
| Genetic predisposition to hyperinflammation | Determination of functional single nucleotide polymorphisms of inflammatory genes and receptors | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, Critical illness, Hypercytokinemia, Exosomes, Mesenchymal stem cells, Tissue reconstitution, Immune modulation, Sepsis
Study In Patients With Dyslipidaemia

Study Overview
=================
Brief Summary
-----------------
Study in patients with dyslipidaemia.

Official Title
-----------------
A Randomised,Double-blind, Parallel Group, Placebo-controlled, Multicentre Study to Evaluate the Safety, Tolerability and Efficacy of Oral GW677954 Capsules 2.5mg, 5mg, 10mg and 20mg a Day for 24 Weeks in Overweight Dyslipidaemic Subjects

Conditions
-----------------
Metabolic Syndrome X

Intervention / Treatment
-----------------
* Drug: GW677954


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Waist circumference =102cm (men) or =88cm (women) at visit 1. Fasting plasma HDL C =40mg/dL (1.03mmol/L) (men) or =50mg/dL (1.29mmol/L) (women) at Screening Visit 1. Fasting TGs =150mg/dL (1.69mmol/L) and =800mg/dL (8.96mmol/L) at Screening Visit 1. Subjects whose plasma LDL C concentration does not require treatment according to the NCEP ATP III guidelines at Screening Visit 1. Exclusion Criteria: History of diabetes History of cardiovascular disease Diagnosis of genetic lipid disorders History of muscle pain History of cancer

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GW677954|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change from baseline in non-HDL-C based on log-transformed data at week 24. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change from baseline in lipids, in Homeostasis Model Assessment-insulin sensitivity (HOMA-S), C-Reactive Protein (CRP), Fasting Plasma Glucose (FPG), body weight and waist circumference. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dyslipidaemia
Radiofrequency Ablation in Treating Patients With Refractory or Advanced Lung Cancer

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Radiofrequency ablation uses high-frequency electric current to kill tumor cells. CT-guided radiofrequency ablation may be effective treatment for lung cancer. PURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation in treating patients who have refractory or advanced lung cancer.

Detailed Description
-----------------
OBJECTIVES: Determine the safety and toxicity of radiofrequency ablation in patients with refractory or advanced pulmonary malignancies. Determine the efficacy of this treatment, in terms of local control, in these patients. Determine whether CT scan is a reasonable imaging assessment tool for treatment delivery and follow-up in these patients. OUTLINE: Patients undergo percutaneous CT-guided radiofrequency ablation directly to the tumor over 2 hours. Patients are followed at 1, 3, 6, and 12 months. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Official Title
-----------------
Radiofrequency Ablation of Pulmonary Malignancy

Conditions
-----------------
Lung Cancer, Malignant Mesothelioma, Metastatic Cancer, Thymoma and Thymic Carcinoma

Intervention / Treatment
-----------------
* Procedure: radiofrequency ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of a primary or secondary intrathoracic malignancy Any cell type or origin Involving the intrapulmonary, mediastinal, or pleural/chest wall Inoperable primary or metastatic cancer to the lung Refractory to or not amenable to conventional therapy (e.g., surgery, chemotherapy, or radiotherapy) Single or multiple lesions that are non-contiguous with vital structures or organs such as: Trachea Heart Aorta Great vessels Esophagus Less than 5 cm in largest dimension Accessible via percutaneous transthoracic route Hepatic: Coagulation profile normal
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

| Intervention/Treatment |
| --- |
|Procedure: radiofrequency ablation|nan|

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
-----------------
recurrent non-small cell lung cancer, recurrent small cell lung cancer, recurrent malignant mesothelioma, recurrent thymoma and thymic carcinoma, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, pulmonary carcinoid tumor, lung metastases
Vaginal Misoprostol and Foley Catheter for Late Second Trimester Termination of Pregnancy

Study Overview
=================
Brief Summary
-----------------
Vaginal Misoprostol Versus Combined Low Dose Misoprostol Plus Foley Catheter for Late Second Trimester Termination of Pregnancy With Previous Multiple Cesarean Sections

Detailed Description
-----------------
this study aims to compare between Vaginal Misoprostol and Combined Low Dose Misoprostol Plus Foley Catheter for Late Second Trimester Termination of Pregnancy With Previous Multiple Cesarean Sections to assess safety and efficacy of theses methods.

Official Title
-----------------
Low Dose Vaginal Misoprostol With or Without Foley Catheter for Late Second Trimester Pregnancy Termination in Women With Previous Multiple Cesarean Sections

Conditions
-----------------
Late Second Trimester Termination of Pregnancy

Intervention / Treatment
-----------------
* Drug: MisoprostoL
* Device: Foley Catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:late second trimester IUFD Previous Multiple Cesarean Sections Exclusion Criteria:Low lying placenta asthma allergy to misoprostol patient refuse to participate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaginal Misoprosto<br>Vaginal Misoprosto for Late Second Trimester Termination of Pregnancy With Previous Multiple Cesarean Section | Drug: MisoprostoL<br>* Vaginal MisoprostoL<br>* Other names: CYTOTEC;|
| Active Comparator: Misoprostol Plus Foley Catheter<br>Misoprostol Plus Foley Catheter for Late Second Trimester Termination of Pregnancy With Previous Multiple Cesarean Sections | Drug: MisoprostoL<br>* Vaginal MisoprostoL<br>* Other names: CYTOTEC;Device: Foley Catheter<br>* Misoprostol Plus Foley Catheter<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| induction to expulsion interval | from time to start induction to time of complete expulsion of product of conception | 24 hours |
Longterm Influence of Pediatric Long COVID Syndrome

Study Overview
=================
Brief Summary
-----------------
We enroll pediatric patients who were diagnosed COVID-19 for main observation target. We will perform brain MRI and neuropsychiatric evaluation 4-6 months after COVID-19 diagnosed. We also enroll healthy age- and gender-matched participant for cross-over comparison. We will perform same evaluation process one year later for longitudinal evaluation

Official Title
-----------------
Longterm Influence of Pediatric Long COVID Syndrome on the Neuropsychiatric Function, Social Function, Neuroimage, and Gut Microbiota

Conditions
-----------------
COVID-19-Associated Encephalitis, Long COVID

Intervention / Treatment
-----------------
* Diagnostic Test: Brain MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 6-18 years old Has been diagnosed COVID-19 before Exclusion Criteria: History of neuropsychiatric disorders Have some device not allowed for MRI

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 18 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 |
| --- | --- |
| Coronavirus disease (COVID)<br>Pediatric patients who was diagnosed as COVID | Diagnostic Test: Brain MRI<br>* Brain MRI including diffusion spectrum image, and functional MRI Interview with questionnaires for neuropsychiatric evaluation Near infrared spectroscopy and resting-state connectivity evaluation<br>* Other names: Near infrared spectroscopy;|
| Healthy<br>Pediatric participants who hadn't been diagnosed COVID before | Diagnostic Test: Brain MRI<br>* Brain MRI including diffusion spectrum image, and functional MRI Interview with questionnaires for neuropsychiatric evaluation Near infrared spectroscopy and resting-state connectivity evaluation<br>* Other names: Near infrared spectroscopy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between COVID and healthy group | The neuroimage difference between COVID and healthy group and the correlation with neuropsychiatric evaluation | 1 years after enrollment for primary evaluation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pediatric neurology, psychiatric evaluation, Long COVID syndrome, magnetic resonance image
Cognis and Teligen 100 HE and Reliance Quadripolar Defibrillation Lead (4-Site) Field Following

Study Overview
=================
Brief Summary
-----------------
The COGENT-4 Field Following Study will evaluate the clinical performance of the Boston Scientific TELIGEN 100 HE Implantable Cardioverter Defibrillator (ICD), the COGNIS 100 HE Cardiac Resynchronization Therapy ICD (CRT-D) systems and the RELIANCE 4-SITE defibrillation lead (when available). An optional sub-study will also evaluate the clinical performance of the Reverse Mode Switch (RMS) feature in the TELIGEN 100 HE DR ICD.

Official Title
-----------------
Cognis and Teligen 100 HE and Reliance Quadripolar Defibrillation Lead (4-Site) Field Following

Conditions
-----------------
Ventricular Tachycardia, Ventricular Fibrillation, Heart Failure

Intervention / Treatment
-----------------
* Device: Cognis 100-D, Teligen DR, VR 100 HE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ICD indication according to normal clinical practice (for those patients receiving a TELIGEN 100 HE) CRT-D indication according to normal clinical practice (for those patients receiving a COGNIS 100 HE) Willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigational centre and at the intervals defined by this protocol Geographically stable patients who are available for follow-up at a study centre Age 18 or above, or of legal age to give informed consent specific to national law Exclusion Criteria: Documented life expectancy of less than six months or expected to undergo heart transplant within the next six months Patients currently requiring dialysis Women who are pregnant or plan to become pregnant. Method of assessment per physician discretion Enrolled in any concurrent study Patients implanted with the following leads which will not be abandoned: Atrial or right ventricular unipolar leads Patch defibrillation leads Non-compatible defibrillation leads (e.g. 5/6mm)

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 |
| --- |
|Device: Cognis 100-D, Teligen DR, VR 100 HE|ICD or CRT - Therapy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appropriate detection of ventricular arrhythmias |  | Predischarge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appropriate shock conversion |  | Predischarge |
Carbon Dioxide Infusion:Clinical and Histological Appraisal in Chronic Wounds

Study Overview
=================
Brief Summary
-----------------
Carbon dioxide infusion is a non surgical procedure applied via percutaneous, transdermal and subcutaneous. Increase in the concentration of carbon dioxide decreases pH activating local nitric oxide that stimulates collateral vessels formation, vascular endothelial growth factor and basic fibroblast growth factor. Carbon dioxide infusion restores the blood flow in chronic wounds of the lower limbs.

Detailed Description
-----------------
Ten patients with chronic wounds caused by venous insufficiency at both lower limbs were distributed into groups. Group I was composed by wounds in the right lower limb that received carbon dioxide and group II by wounds in the left lower limb that not received carbon dioxide, both related to the same patient. Carbon dioxide infusion was performed with the needle pointed toward the granulation tissue, 5cm distant from each one at intervals of 4 days. Biopsies were collected from the wounds before carbon dioxide infusion and after the 3rd, 5th and 10th application. Statistical analysis of the data was performed using Wilcoxon's test and Friedman's variance analysis and multiple comparisons test.

Official Title
-----------------
Carbon Dioxide Infusion:Clinical and Histological Appraisal in Chronic Wounds

Conditions
-----------------
Wounds

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic wounds caused by venous insufficiency Exclusion Criteria: other diseases of the lower limbs

Ages Eligible for Study
-----------------
Minimum Age: 49 Years
Maximum Age: 59 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 |
| --- | --- |
| carbon dioxide infusion<br>Group I: receive carbon dioxide infusion | |
| control<br>did not receive carbon dioxide | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dilatation of peripheral blood vessels, number of capillaries, macrophages and fibroblasts |  | 10 sessions (5 weeks) per patient | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
carbon dioxide infusion, dilatation of peripheral blood vessels, capillaries, macrophags, fibroblasts, Improvement granulation tissue in chronic wounds
ctDNA Monitoring in Early Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This is a observational, single center study, monitoring the circulating tumor DNA (ctDNA) in patients with early breast cancer and assessing the prognostic value and treatment outcome monitoring of ctDNA.

Official Title
-----------------
Monitoring Circulating Tumor DNA in Patients With Early Stage Breast Cancer

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 18 to 80 years old Histologically proven primary breast cancer with clinical stage I-III Patients with neoadjuvant therapy, and/or radical surgery/breast conserving surgery, adjuvant chemotherapy and target therapy (Her2+), radiotherapy (if indicated). Expected to achieve R0 resection. Estimated lifetime is more than 3 months. Signed Informed Consent Form Consent to provide research blood samples. Exclusion Criteria: Patients intended to receive adjuvant chemotherapy with Eastern Cooperative Oncology Group (ECOG) performance status 3, 4 or 5. Patients intended to receive postoperative radiotherapy with Eastern Cooperative Oncology Group (ECOG) performance status 5. Prior diagnosis of cancer in the previous 5 years, other than for basal cell carcinoma of the skin or cervical carcinoma in situ. Presence of any systemic illness incompatible with participation in the clinical trial or inability to provide written informed consent.

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 |
| --- | --- | --- |
| Positive ctDNA detection at first post-operative timepoint | The proportion of patients with ctDNA positivity as assessed by the blood sample taken at first post-operative timepoint | 1 month post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive ctDNA detection at post-operative timepoints | The proportion of patients with ctDNA positivity as assessed by the blood sample taken at other post-operative timepoints | 6/12/18/24/30 months | 
| Association between ctDNA detection and time to recurrence | Time to recurrence of subgroups with detectable ctDNA and undetectable ctDNA comparison. | 1 month post-surgery | 
| Association between ctDNA detection and time to recurrence | Time to recurrence of subgroups with detectable ctDNA and undetectable ctDNA | 6/12/18/24/30 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ctDNA