linjc16/ctgov huggingface dataset:
Registry of Emergent Large veSsel oCclUsion duE to IntraCranial AtherosclerosiS

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to develop an international multicenter registry of patient data and outcomes for patients undergoing mechanical thrombectomy for emergent large vessel occlusion with residual underlying stenosis following successful revascularization.

Official Title
-----------------
Registry of Emergent Large veSsel oCclUsion duE to IntraCranial AtherosclerosiS

Conditions
-----------------
Intracranial Stenosis, Large Vessel Occlusion, Mechanical Thrombectomy

Intervention / Treatment
-----------------
* Other: No Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing mechanical thrombectomy AND have intracranial stenosis Patients aged 18-90 years Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Participants with Intracranial Stenosis<br>Patients with Intracranial Stenosis who undergo Mechanical Thrombectomy will be added to the registry given they meet the age inclusion criteria. | Other: No Intervention<br>* No intervention, prospective data collection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified Rankin score | standard stroke score measuring disability level delivered by physician with level 0-6 with 0 being no symptoms and 6 being death. Outcome measured by the distribution of mRS score. | pre-stroke | 
| modified Rankin score | standard stroke score measuring disability level delivered by physician with level 0-6 with 0 being no symptoms and 6 being death. Outcome measured by the distribution of mRS score. | 7 days | 
| modified Rankin score | standard stroke score measuring disability level delivered by physician with level 0-6 with 0 being no symptoms and 6 being death. Outcome measured by the distribution of mRS score. | admission | 
| modified Rankin score | standard stroke score measuring disability level delivered by physician with level 0-6 with 0 being no symptoms and 6 being death. Outcome measured by the distribution of mRS score. | 3 months | 
| Mortality | Death at 90 days post intervention | 90 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intracranial Stenosis, Large Vessel Occlusion
Valproic Acid With Methylprenisonlone for the Treatment of Acute GVHD

Study Overview
=================
Brief Summary
-----------------
aGVHD remains as complication in patients after allogeneic stem cell transplantation. Methylprednisolone at 1 2mg/kg is considered as standard first-line treatment. In recent lab study, we demonstrated that valproic acid (VPA) as histone deacetylase inhibitor can inhibit CD4+ Th1 and Th17 cells and control the aGVDH in mice model while preserve the GVL effects. In this study, we tested the hypothesis that adding VPA to standard dose steroid treatment may improve the outcome of aGVHD.

Detailed Description
-----------------
To evaluate the complete response rate of VPA+Methylpednisolone in patients with Grade II-IV aGVHD after allogenetic stem cell transplantation.

Official Title
-----------------
Phase II Study of Valproic Acid With Methylprenisonlone for the Treatment of Grade II-IV Acute GVHD in Patients After Allogeneic Stem Cell Transplantation

Conditions
-----------------
Peripheral Blood Stem Cell Transplantation, aGVHD

Intervention / Treatment
-----------------
* Drug: VPA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Grade II-IV aGVHD No previous history of allergy to valproic acid No active and severe infection Exclusion Criteria: Inclusion in other clinical trial GVHD Prophylaxis with valproic acid severe organ dysfunction: heart, lung, liver and kidney

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VPA+Methyl<br>VPA added to standard methylpredisonlone treatment for aGVHD | Drug: VPA<br>* Valproic acid with 1000mg loading dose with 500mg q12 4 hours later to maintain a trough level above 75ug/ml<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete response |  | 28 days after the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response (complete + partial response) |  | 28 days after the treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aGVHD, valproic acid
Surgery for Mesothelioma After Radiation Therapy SMART for Resectable Malignant Pleural Mesothelioma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether radiation therapy decreases tumor size and tumor spread. The investigators will consent subjects that have been diagnosed with mesothelioma and will undergo radiation therapy followed by surgical resection as their standard of care. The investigators will collect data from past and future medical records as well as data regarding their health status for their lifetime by reviewing life status, treatment status and CT scans.

Official Title
-----------------
Surgery for Mesothelioma After Radiation Therapy SMART for Resectable Malignant Pleural Mesothelioma

Conditions
-----------------
Mesothelioma, Solitary Fibrous Tumor of the Pleura

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject provides informed consent Subject is >18 years of age Subject is deemed competent for making medical decisions Subject is scheduled to undergo radiation followed by extrapleural pneumonectomy. Subject is a surgical candidate A negative pregnancy test is required in women of child-bearing potential, as standard of care. Exclusion Criteria: Subject is <18 years old.

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 |
| --- | --- | --- |
| Survival status upon review of patient records every 6 months |  | 2 years |
Penetrating Gunshot Injuries at a Single Johannesburg Centre

Study Overview
=================
Brief Summary
-----------------
A retrospective audit of cardiac penetrating cardiac injuries with specific reference to GSW

Detailed Description
-----------------
A descriptive retrospective study looking at the outcomes in patients with penetrating cardiac injuries especially following gunshot injuries. The physiology on presentation, the ISS, the RTS, the clinical injuries confirmed, the type of investigations conducted, the length of hospital stay, the in-hospital mortality will all be collected. Descriptive study statistics will be utilized and a p-value of <0,05 will be considered statistically significant.

Official Title
-----------------
Penetrating Gunshot Cardiac Injuries: Single Centre Experience

Conditions
-----------------
Trauma

Intervention / Treatment
-----------------
* Other: Standard clinical management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all adult Priority 1 patients with GSW cardiac injuries seen at a Johannesburg Trauma facility Exclusion Criteria: Incomplete data or dead on arrival

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: Standard clinical management|outcomes in GSW cardiac injuries|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Injury patterns (check list) | Document cardiac injuries noted in the study group | 01 Jan 2008 till 31 December 2018 | 
| The number of in-hospital patients who survive the injury |  | 01 jan 2008 till 31 December 2018 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac, penetrating, GSW
Diastolic Dysfunction and Interstitial Lung Edema in Septic Patients

Study Overview
=================
Brief Summary
-----------------
Sepsis is one of the most challenging conditions with an exceptionally high mortality rate. Diastolic Dysfunction is common in septic patients and has been found to be associated with mortality. However, the reasons for this remain unclear. Therefore, the goal of this study is to investigate diastolic dysfunction in septic patients on the intensive care unit. Special attention is paid to the presence of lung edema and general edema as a potential link between diastolic dysfunction and elevated mortality in septic patients. During the septic phase daily ultrasound examinations of heart and lung will be performed as to monitor diastolic function and lung edema.

Official Title
-----------------
Left Ventricular Diastolic Dysfunction as a Risk Factor for Interstitial Lung Edema in Septic Patients on the Intensive Care Unit

Conditions
-----------------
Sepsis, Diastolic Dysfunction, Lung Edema, Fluid Overload

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients on the intensive care unit diagnosed with SIRS (systemic inflammatory response syndrome) or Sepsis. Exclusion Criteria: Patients with hemodynamically relevant cardiac defects. Patients with mitral valve replacement. Patients with pericardial effusion. Patients with atrial fibrillation. Patients with pacemaker therapy. Patients with BMI > 35 kg/m2. Patients with poor examination conditions for ultrasound.

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 |
| --- | --- |
| Diastolic Dysfunction<br>Patients with pre-existing or new diastolic dysfunction. | |
| Normal Diastolic Function<br>Patients with normal diastolic function. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diastolic Dysfunction | Diastolic Dysfunction specified by echocardiographic doppler derived mitral inflow pattern and tissue doppler derived diastolic mitral annular velocities (E/E'). | While in septic condition, up to 10 days maximum. | 
| Pulmonary Edema | Pulmonary edema specified by B line ultrasound score (Lung ultrasound protocol for the assessment of pulmonary fluid status according to Enghardt et al. 2015). | While in septic condition, up to 10 days maximum. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intensive care unit, echocardiography
GW823093C For The Treatment Of Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
This study was designed to find dose response and as extension in treatment of GW823093C.

Official Title
-----------------
GW823093 Japan Phase IIa Mono

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

Intervention / Treatment
-----------------
* Drug: GW823093C A
* Drug: GW823093C B
* Drug: GW823093C C


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Type 2 diabetes mellitus. Managed by diet therapy or receiving treatment with oral anti-diabetic monotherapy (excluding TZD (Thiazolidinediones)) Exclusion criteria: Patients who have metabolic disease judged by investigator as a clinically significance Serious cardiovascular disease or serious hepatic disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 74 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 |
| --- | --- |
| Placebo Comparator: GW823093C A<br>A=45 mg | Drug: GW823093C A<br>* A=45 mg<br>|
| Placebo Comparator: GW823093C B<br>B=30 mg | Drug: GW823093C B<br>* B=30 mg<br>|
| Placebo Comparator: GW823093C C<br>C=15 mg | Drug: GW823093C C<br>* C=25 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy variables Dose response (change from baseline in HbA1c) at stipulated date in each treatment group |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term safety variables |  | 64 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GW823093C, diabetes, type 2 diabetes mellitus, DPP-IV inhibitor
Reconstruction of the Medial Patellofemoral Ligament - A Randomised Controlled Trial Comparing Two Surgery Technics

Study Overview
=================
Brief Summary
-----------------
The purpose of this present study is to determine which surgery technic provides the best clinical outcome after medial patellofemoral ligament reconstruction comparing suture anchors and screw fixation in medial femoral condyle.

Official Title
-----------------
Reconstruction of the Medial Patellofemoral Ligament - A Randomised Controlled Trial Comparing Two Surgery Technics

Conditions
-----------------
Knee Stability, Patella Luxation

Intervention / Treatment
-----------------
* Other: Anchor fixation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patella luxation, more than 2 times Exclusion Criteria: cartilage damage (grad 3)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Anchor fixation<br>Medial fixation of the reconstruction at the medial femural condyle with suture anchors. | Other: Anchor fixation<br> <br> |
| Other: Screw fixation<br>Medial fixation of the reconstruction at the medial femural condyle with a screw. | Other: Anchor fixation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of subjective symptoms with a patient reported outcome score | Anterior Knee Pain Scale | Baseline, 6 months 12 Months, 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported outcome scores | Tegner | Baseline, 6 months 12 Months, 24 months | 
| Patient reported outcome scores | KOOS (Knee injury and osteoarthritis outcome score) | Baseline, 6 months 12 Months, 24 months | 
| Re-operation rate |  | Baseline, 6 months 12 Months, 24 months |
Obturator Block in Lateral Tumors of the Bladder: Does it Have Adverse Effects on Early Postoperative Mobilization?

Study Overview
=================
Brief Summary
-----------------
Investigation of delay in postoperative mobilization due to motor block and complications related to block in patients who underwent USG-assisted obturator nerve block with distal approach

Official Title
-----------------
Obturator Block in Lateral Tumors of the Bladder: Does it Have Adverse Effects on Early Postoperative Mobilization?

Conditions
-----------------
Obturator Nerve Block, Ultrasound Guided Nerve Block, Complications Neurological

Intervention / Treatment
-----------------
* Procedure: spinal block and obturator nerve block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 18-75 ASA1, ASA2, ASA 3 physical status Exclusion Criteria: The patient's refusal Active infection in the area to be blocked Kidney failure Liver failure Heart failure BMI less than 18 and a BMI greater than 40

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 |
| --- | --- |
| spinal anesthesia<br>spinal block will be performed to patients after monitoring | Procedure: spinal block and obturator nerve block<br>* spinal block and obturator nerve block<br>|
| spinal anesthesia and obturator nerve block<br>spinal block will be performed to patients after monitoring, and then the patients in the ONB block group will be given the appropriate position, with a USG-assisted distal approach, 5 cc %2 prilocain into the anterior and 5cc %2 prilocain into the posterior branch of the obturator nerve. | Procedure: spinal block and obturator nerve block<br>* spinal block and obturator nerve block<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pin prick test | postoperatively sensation block | postoperatively 2nd hour | 
| bromage score | motorial block | postoperatively 2nd hour | 
| pin prick test | postoperatively sensation block | postoperatively 5th hour | 
| bromage score | motorial block | postoperatively 5th hour |
A New EBV Related Technologies of T Cells in Treating Malignant Tumors and Clinical Application

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety of the designed LMP1-CAR -T cells and determine whether the CAR-T cells are effective in the treatment of EBV associated malignant tumors.

Detailed Description
-----------------
Half of the patients will treat with LMP1-CAR-T cells,while the other half will receive a placebo.During the time of the treatment ,we will supervise the side effect of treated group.At last we compare the survival rate and health condition of the two groups.

Official Title
-----------------
A New Efficient EBV AssociatedTechnologies of T Cells in Treating Malignant Tumors and Clinical Application

Conditions
-----------------
Nasopharyngeal Neoplasms

Intervention / Treatment
-----------------
* Other: CAR-T cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of nasopharyngeal carcinoma Exclusion Criteria: •pregnant woman severe autoimmune diseases serious infection
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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAR-T cells<br>the group treat with CAR-T cells | Other: CAR-T cells<br>* the patients treat with CAR-T cells<br>* Other names: adoptive immunotherapy;|
| No Intervention: placebo<br>the group treat with CAR-T cells | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nasopharyngeal carcinoma, EBV related cancers
Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Japanese Subjects

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Japan. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 50 (NN-X14Mix50) in healthy Japanese subjects.

Official Title
-----------------
A Randomised, Double-blind, Single-centre, Two-Period Crossover Trial Testing the Bioequivalence of Two Formulations of NN-X14Mix50 in Healthy Japanese Subjects

Conditions
-----------------
Diabetes, Healthy

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart 50


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI (body mass index) between 19-29 kg/m^2 (both inclusive) Fasting blood glucose between 3.8-6.0 mmol/L (both inclusive) Non-smokers Exclusion Criteria: Subjects with a first-degree relative with diabetes mellitus Subjects smoke 5 cigarettes or more per day

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Formulation A<br> | Drug: biphasic insulin aspart 50<br>* A single dose administrated subcutaneously (s.c., under the skin) on two separate dosing visits. A wash-out period of 6-21 days will take place between dosing visits<br>|
| Experimental: Formulation B<br> | Drug: biphasic insulin aspart 50<br>* A single dose administrated subcutaneously (s.c., under the skin) on two separate dosing visits. A wash-out period of 6-21 days will take place between dosing visits<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the insulin aspart curve in the interval from 0-16 hours |  |  | 
| Cmax, maximum insulin aspart concentration |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tmax, time to maximum insulin aspart concentration |  |  | 
| Area under the insulin aspart curve |  |  | 
| Mean residence time (MRT) |  |  | 
| t½, terminal half-life |  |  | 
| Adverse events |  |  |