linjc16/ctgov huggingface dataset:
A Study to Evaluate Safety and Efficacy of IBI306, a PCSK9 Monoclonal Antibody in Chinese Subjects With Homozygous Familial Hypercholesterolemia

Study Overview
=================
Brief Summary
-----------------
A study to evaluate safety and efficacy of IBI306 in subjects with homozygous familial hypercholesterolemia.

Detailed Description
-----------------
This is a phase 2b/3 study to assess the efficacy and safety of IBI306 in subjects with homozygous familial hypercholesterolemia. Part 1 is an open-label, two-arm, multicenter pilot study to evaluate efficacy and safety of IBI306 in subjects with homozygous familial hypercholesterolemia. Part 2 is an open-label, single-arm, multicenter study to evaluate efficacy and safety of IBI306 in subjects with homozygous familial hypercholesterolemia.

Official Title
-----------------
Phase 2b/3 Study to Assess the Efficacy and Safety of IBI306 in Subjects With Homozygous Familial Hypercholesterolemia.

Conditions
-----------------
Homozygous Familial Hypercholesterolemia

Intervention / Treatment
-----------------
* Biological: IBI306
* Biological: IBI306


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females ≥ 18 to ≤ 80 years of age Diagnosis of homozygous familial hypercholesterolemia LDL cholesterol ≥ 130 mg/dL (3.4mmol/L) Triglyceride ≤ 400 mg/dL (4.5 mmol/L) Bodyweight of ≥ 40 kg at screening Exclusion Criteria: History of liver transplant Uncontrolled hypertension Moderate to severe renal dysfunction Active liver disease or hepatic dysfunction Known sensitivity to any of the products to be administered during dosing

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 12 [ Time Frame: Baseline and Week 12 ]
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1: IBI306<br>Participants receive open-label IBI306 150 mg subcutaneously Q2W or 450 mg Q4W for 12 weeks. | Biological: IBI306<br>* Administered by subcutaneous injection<br>|
| Experimental: Part 2: IBI306<br>Participants receive open-label 450 mg Q4W subcutaneously for 12 weeks. | Biological: IBI306<br>* Administered by subcutaneous injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part 1: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C). |  | Baseline and Week 12 | 
| Part 2: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) |  | Baseline and Week 12 |
Neurophysiological Intraoperative or Epilepsy Monitoring

Study Overview
=================
Brief Summary
-----------------
The investigators record the outcome of patients whose surgery involved intraoperative neurophysiological monitoring Trial with surgical intervention

Official Title
-----------------
Retrospective Data Analysis of Neurophysiological Data for Intraoperative or Epilepsy Monitoring

Conditions
-----------------
Patients Operated on at the Neurosurgery Department

Intervention / Treatment
-----------------
* Device: Intraoperative Neurophysiological Monitoring IONM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients whose surgery involved intraoperative neurophysiological monitoring

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 100 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 |
| --- | --- |
| IONM patients<br>all patients where surgery requires IONM | Device: Intraoperative Neurophysiological Monitoring IONM<br>* Intraoperative Neurophysiological Monitoring IONM device. Manufacturer: Inomed, Emmendingen, Germany<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oncological outcome | overall survival, progression free survival | 5 years | 
| neurological outcome | validated scales like Karnofsky or NIHSS | 1 year | 
| seizure outcome | ILAE classification of epilepsy surgery outcome | 1 year |
The BRAvAdO Registry

Study Overview
=================
Brief Summary
-----------------
The BRAVADO Registry pretends to identify stratification, diagnosis, total atherosclerotic burden and treatment approaches in oncologic patients with Acute Coronary Syndrome (ACS) and identify strategies to improve health care quality

Official Title
-----------------
BRAzilian Registry of Acute Coronary Syndrome in Oncologic Patients - The BRAvAdO Registry

Conditions
-----------------
ACS - Acute Coronary Syndrome, Oncology

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Definitive cancer diagnosis - biopsy Acute Coronary Syndrome - requiring urgent invasive risk stratification Exclusion Criteria: KPS < 60 , ECOG >/ 3 Life expectancy less 24hs End of Life Care Lack of consistent record data

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Major adverse cardiovascular events | Composite endpoint of All-cause Death, Myocardial Infarction, Stroke and Myocardial Revascularization | 30 days | 
| Total Atherosclerotic burden and lesion complexity on angiography | The number and location of coronary lesions with obstructions greater than 50% were recorded. Each lesion was classified based on Ambrose's, Goldstein complexity, Leaman and SYNTAX scores. | 30 days | 
| Incidence of Major Bleeding | Requiring a transfusion of ≥2 U PRBCs Resulting in a decrease in hematocrit of ≥10% Occurring intracerebrally Resulting in stroke or death | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardio-Oncology, Interventional Cardiology, Cancer, Oncology, Acute Coronary Syndrome, Myocardial Infarction
Safety and Performance of the Neuroform Atlas™ Stent System

Study Overview
=================
Brief Summary
-----------------
The objective of this retrospective study is to describe in real-life settings the clinical practice, utilization and the treated population outcomes at 1-year (12-16 months) follow-up at selected, representative centers in France.

Detailed Description
-----------------
This proposed ATLAS FR study will be a retrospective review conducted to expand our knowledge of the clinical outcomes in subjects treated in France between 01 February 2017 and 01 March 2018. This will provide a comprehensive data set that is specifically representative of the Atlas stent use in France.

Official Title
-----------------
Safety and Performance of the Neuroform Atlas™ Stent System in Patients Requiring Stent Assisted Intracranial Aneurysm Treatment in France - A National, Retrospective Multi-center Registry

Conditions
-----------------
Intracranial Aneurysm

Intervention / Treatment
-----------------
* Device: Neuroform Atlas Stent System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient who had undergone a stent assisted intracranial aneurysm coiling with Neuroform Atlas for the treatment of intracranial aneurysm(s) between 1st Feb 2017 and 1st March 2 018. Patient and/or their representative have/has received the written information concerning the study and not expressed opposition to the collection of his data
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Neuroform Atlas Stent System|Stenting Assisted coiling procedure|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| permanent morbidity and mortality rate | any major ipsilateral stroke or neurological death | up to 12-16 months post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AEs and device malfunctions | All intra-procedural AEs and device malfunctions | peri-procedure | 
| Efficacy Endpoint with mRS | Proportion of aneurysms with Raymond-Roy Occlusion Class I, II or III | immediately post-procedure and at 12-16 months post procedure | 
| Retreatment | Occurence of re-treatment | up to 12-16 months | 
| Subarachnoid hemorrhage (SAH) | Occurence of SAH | Up to 12-16 months | 
| Aneurysm rupture/re-rupture | Occurence of Aneurysm rupture/re-rupture | Up to 12-16 months | 
| SAEs resulting in neurological death | Rate of SAEs resulting in neurological death | Up to 12-16 months | 
| device-related SAEs | Occurence of device-related SAEs | Up to 12-16 months |
Comparison of Biphasic Insulin Aspart Produced by the NN2000 Process to Current Process to in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Japan. The aim of this trial was to investigate the safety and efficacy of NN2000-Mix30 produced by NN2000 process compared to that of NN-X14Mix30 produced by current process in Japanese subjects with type 2 diabetes.

Official Title
-----------------
A 24-week, Randomised, Multi-centre, Double-blind, Parallel-group Trial to Investigate the Safety and the Efficacy of NN2000-Mix30 Compared to NN-X14Mix30 NovoRapid®30Mix) in Subjects With Type 2 Diabetes Mellitus on a Twice Daily Regimen

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with type 2 diabetes Subjects with insulin treatment for at least 24 weeks Current treatment with premixed biphasic human insulin preparation for at least 12 weeks HbA1c lesser than or equal to 11.0% Exclusion Criteria: Recurrent severe hypoglycaemia Proliferative retinopathy or maculopathy requiring acute treatment Impaired renal function Cardiac diseases Uncontrolled hypertension Subjects with known malignant tumour Total daily insulin dose greater than or equal to 100 IU

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: biphasic insulin aspart|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  | During 24 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  |  |
Study of the Role of Hemostasis in Perioperative Anaphylaxis

Study Overview
=================
Brief Summary
-----------------
Anaphylaxis is a severe and life-threatening complication during the perioperative period. Perioperative anaphylaxis is still associated with a significant mortality despite quick and efficient management using epinephrine, the mainstay of acute treatment. Experimental data and few case reports are suggesting that hemostasis, and more precisely platelets, could play a role in anaphylaxis. Our main hypothesis is that activation of the hemostatic system contributes to the severity of the reaction

Official Title
-----------------
Study of the Role of Hemostasis in Perioperative Anaphylaxis

Conditions
-----------------
Hemoptysis, Perioperative Complication, Anaphylaxis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient, male or female, adult In the perioperative period In whom the diagnosis of anaphylactic shock is suggested Patient is giving his consent to participate in the study Exclusion Criteria: Subject under legal protection Subject under guardianship or guardianship Anemia less than 7 g /dl at the time of inclusion

Ages Eligible for Study
-----------------
Minimum Age: 2 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 |
| --- | --- | --- |
| Platelet activation | Measurement of: Plasmatic serotonin level, Plasmatic PF-4 level, P-selectin expression (MFI, %), Platelet count | As soon as possible after onset of anaphylaxis | 
| Platelet activation | Measurement of: Plasmatic serotonin level, Plasmatic PF-4 level, P-selectin expression (MFI, %), Platelet count | 1-2 hours after the onset of anaphylaxis | 
| Platelet activation | Measurement of: Plasmatic serotonin level, Plasmatic PF-4 level, P-selectin expression (MFI, %), Platelet count | 24 hours after the onset of anaphylaxis | 
| Platelet activation | Measurement of: Plasmatic serotonin level, Plasmatic PF-4 level, P-selectin expression (MFI, %), Platelet count | During the allergic workup (4-6 weeks after) |
Impact of Ventricular Pacing in Unselected ICD/CRT-D Patients

Study Overview
=================
Brief Summary
-----------------
Observational study is evaluating Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) thérapies as a function of ventricular pacing

Detailed Description
-----------------
This protocol consists in a non-interventional multi-centre, prospective study. The observational study will also answer the question of the impact of ventricular pacing on the outcome of patients implanted with ICD & CRT-D devices and how the ICD & CRT-D devices are used in clinical practice through two years follow-up.

Official Title
-----------------
Impact of Ventricular Pacing in Unselected ICD/CRT-D Patients

Conditions
-----------------
Ventricular Tachycardia, Ventricular Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Main inclusion Criteria: •Patient implanted (primo implantation or replacement) with an ICD (OVATIO VR 6250, DR 6550, CRT 6750 models, or any similar or higher range device, that includes specific diagnostic and therapeutic functionalities, mandatory to make homogeneous the collection of data) Main exclusion Criteria: Presence of a contra-indication to the ICD therapy. Life expectancy less than 12 months.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| VT/VF episodes according to ventricular pacing (> and <50%) | Device-based data | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Impact of ventricular pacing on the incidence of VT/VF episodes for each models
Mood Stabilizer-induced Metabolic Abnormalities in Bipolar Disorder

Study Overview
=================
Brief Summary
-----------------
The potential effects of microbiota in bipolar disorder (BD) with microbiota-related dysfunction have not yet been explored clinically, and the integration of microbiota and pharmacometabolomic approaches can provide us the identification of the significant effects of mood stabilizers on metabolic homeostasis, treatment response, and cognitive performance. Therefore, we propose to develop the integration of the microbiota and pharmacometabolomics knowledge base about the mood stabilizer-induced metabolic abnormalities in BD patients.

Conditions
-----------------
Bipolar Disorder

Intervention / Treatment
-----------------
* Drug: Valproic Acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bipolar disorder outpatients (aged 18-65 years) who meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) diagnostic criteria and start to receive valproate (VPA) will be enrolled consecutively by trained psychiatrists. Exclusion Criteria: Exclude are patients who had DSM-V diagnosis for substance abuse within the past three months Had treated with antibiotics and/or functional foods (probiotics and/or prebiotics) for at least one month before entering study Presence of stomach/gut problems such as chronic diarrhea, constipation, gas, heartburn, bloating, etc. Had an organic mental disorder, mental retardation, dementia, or other diagnosed neurological illness Had a surgical condition or a major physical illness Were pregnant or breast-feeding Had any concomitant DSM-V Axis I diagnoses together with somatic or neurologic illnesses interfering psychiatric evaluation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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: Valproic Acid<br> | Drug: Valproic Acid<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut microbiota composition |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic syndrome |  | 12 weeks |
Postpartum Hemorrhage After Shenghua Decoction Treatment

Study Overview
=================
Brief Summary
-----------------
A rare case of disastrous delayed postpartum hemorrhage after three days of shenghua decoction treatment.

Detailed Description
-----------------
A rare case of disastrous delayed postpartum hemorrhage after three days of shenghua decoction treatment.

Official Title
-----------------
Disastrous Delayed Postpartum Hemorrhage After Three Days of Shenghua Decoction Treatment: a Case Report

Conditions
-----------------
Postpartum Hemorrhage

Intervention / Treatment
-----------------
* Drug: Shenghua Decoction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postpartum hemorrhage after shenghua decoction treatment. Exclusion Criteria: Nil

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Shenghua Decoction|Three days' shenghua decoction treatment|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of postpartum hemorrhage or not | Presence of postpartum hemorrhage or not, following three days of shenghua decoction treatment. The total estimated blood loss was approximately 2000 mL at that time. Her hemoglobin was revealed to be 2.6 g/dL, her hematocrit was 8.5%, and the vaginal bleeding persisted despite medications, so emergency total hysterectomy was performed. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postpartum hemorrhage
Treatment of Advanced Gastrointestinal Cancer in a Phase I/II Trial With Modified Autologous MSC_apceth_101

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and tolerability of MSC_apceth_101.

Official Title
-----------------
Treatment of Advanced Gastrointestinal Cancer in a Phase I/II Trial With Modified Autologous MSC_apceth_101

Conditions
-----------------
Advanced Gastrointestinal Cancer

Intervention / Treatment
-----------------
* Drug: MSC_apceth_101


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with advanced or recurrent or metastatic gastrointestinal adenocarcinoma. Premature or scheduled termination of standard therapy Progressive disease as clinically assessed by the investigator Max. tumour lesion ≤ 5 cm Adequate organ function Ability of patient to understand character and individual consequences of clinical trial Age ≥ 18 years Written informed consent must be available before any study specific procedure is performed Exclusion Criteria: Patients with severe heart diseases Clinical significant ischemic disease during the last 4 weeks before Visit 1 Severe lung disease Symptomatic peritoneal carcinomatosis Symptomatic pleural or pericardial effusion Serious uncontrolled acute infections less than 3 weeks before Visit 1 Known dependency on alcohol or other drugs Patients requiring corticoids in doses above the Cushing threshold Known liver fibrosis or liver cirrhosis Any concomitant severe disease which could compromise the objectives of this study in the judgment of the investigator Female patient who is pregnant or breast feeding Participation in another clinical trial or observation period, respectively, during the last 4 weeks prior to the first IMP dose

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: treatment arm<br> | Drug: MSC_apceth_101<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability as indicated by Common Toxicity Criteria (CTC-AE) of the National Cancer Institute |  | day 56 (+/- 7) in patient group 1 and day 29 (+/-3) in patient group 2 |