linjc16/ctgov huggingface dataset:
Use of Gadolinium in CT Pulmonary Angiography

Study Overview
=================
Brief Summary
-----------------
The study will investigate patients with clinical suspicion for pulmonary embolism (PE) who have a contraindication to iodine based contrast. These patients normally get investigated with studies such as ultrasound and nuclear medicine studies but the fastest and preferred investigation is CT with contrast to look for filling defects in the pulmonary arteries. The investigators will assess whether gadolinium, which is currently used with MRI can be used with CT as an alternative effective contrast in diagnosis or exclusion of PE. A new type of CT scanner, a Dual Energy Scanner will be used to improve the visibility of Gadolinium contrast on CT.

Detailed Description
-----------------
Contrast enhancement with Gadolinium will be evaluated to assess its efficacy for diagnosis and exclusion of pulmonary embolism in a patient who previously would not have been investigated with CTPA due to an underlying allergy to contrast or other contraindication. If this proves beneficial, it will allow such patients to be investigated successfully with CTPA

Official Title
-----------------
Efficacy of Gadolinium Contrast in CT Pulmonary Angiography in Patients With Allergy to Iodine

Conditions
-----------------
Pulmonary Embolism

Intervention / Treatment
-----------------
* Drug: Gadolinium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suspected of having a Pulmonary embolus Allergy to Iodine based intravenous contrast Exclusion Criteria: Renal impairment Less than 20 years of age Non-English speaking Pregnancy Allergy to Gadolinium

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gadolinium enhancement<br>Gadolinium enhancement will be performed using intravenous Dotarem[recommended dose of 0.2 mL/kg (0.1 mmol Gd/kg )] | Drug: Gadolinium<br>* agents will be administered intravenously and a CT scan will be performed to evaluate contrast enhancement characteristics of the agents to assess their feasibility as an alternative to Iodine based contrast agents<br>* Other names: Dotarem;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of Pulmonary Embolism | Ability of Gadolinium to diagnose pulmonary embolism on a dual energy CT scan | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary embolism, Contrast, Computed tomography, Gadolinium
A Survey to Evaluate Diabetes Management, Control, Chronic Complications, Psychosocial Aspects of Diabetic Subjects in India

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Asia. The aim of this observational study is to evaluate the current status of diabetes management, control, and complications in diabetic subjects in India. Perceptions and practices of physicians and subjects about diabetes management will also be evaluated.

Official Title
-----------------
A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Diabetic Patients in India and to Evaluate Perceptions and Practices of Physicians and Patients About Diabetes Management in India (DiabCare India 2011)

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients should have visited the centre at least once in the last 3-6 months apart from the initial visit First twenty patients of diabetes visiting the centre during the data collection period Patients willing to sign the informed consent form Exclusion Criteria: Repetition of any patient as patients should not be included twice for any reason Unwilling to participate or unable to comply with protocol requirements
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br> | Other: No treatment given<br>* Patients will fill out a questionaire by interview.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean age of onset of type 1 diabetes mellitus |  | Evaluation visit | 
| Mean age of onset of type 2 diabetes mellitus |  | Evaluation visit | 
| Mean duration of treatment of type 2 diabetes mellitus |  | Evaluation visit | 
| Percentage of patients on Insulin therapy |  | Evaluation visit | 
| Percentage of patients on Oral Anti-Diabetics Drug (OADs) therapy |  | Evaluation visit | 
| Mean duration of diabetes in type 1 patients |  | Evaluation visit | 
| Mean duration of diabetes in type 2 patients |  | Evaluation visit | 
| Mean FPG (fasting plasma glucose) |  | Evaluation visit | 
| PPG (post prandial glucose) |  | Evaluation visit | 
| HbA1c (Glycosylated Haemoglobin) |  | Evaluation visit | 
| Percentage of patients archiving HbA1c target below or equal 6.5% |  | Evaluation visit | 
| Percentage of patients archiving HbA1c target below or equal 7.0% |  | Evaluation visit | 
| Percentage of patients having complications (dyslipidemia and hypertension, cardiovascular complications, peripheral vascular disease, diabetic nephropathy and diabetic eye complications) |  | Evaluation visit |
Limited Compression Ultrasound by Emergency Physicians to Exclude Deep Vein Thrombosis

Study Overview
=================
Brief Summary
-----------------
Deep vein thrombosis is a common condition seen in the Emergency Department. Standard of care for diagnosis of DVT includes a combination of a clinical pre-test probability rule known as Well's criteria, D-dimer blood testing, and Radiology department ultrasound. The purpose of this study is to determine whether Emergency Physicians can safely rule out deep vein thrombosis using Well's criteria and D-dimer blood testing combined with Emergency department bedside ultrasound.

Official Title
-----------------
Can Emergency Physicians Safely Exclude Proximal Deep Vein Thrombosis Using Limited Compression Emergency Department Ultrasound?

Conditions
-----------------
Deep Vein Thrombosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 16 years Clinically suspected lower extremity DVT Exclusion Criteria: Known chronic DVT Acute DVT confirmed by prior formal imaging Inability to assess common femoral or popliteal area (due to cast, above knee amputation, etc.) Anticoagulation >48 hours prior to imaging (formal or LCU)

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| Clinically likely<br>Subjects deemed clinically likely to have DVT based on modified Well's criteria | |
| Clinically unlikely<br>Subjects deemed clinically unlikely to have DVT based on modified Well's criteria | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First co-primary outcome: sensitivity/specificity of LC U/S vs D-dimer in clinically unlikely DVT patients. |  | 3 days | 
| Second co-primary outcome: sensitivity/specificity of LC U/S plus D-dimer vs formal ultrasound in clinically likely DVT patients. |  | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| interobserver reliability of modified Well's criteria |  | 3 days | 
| learning curve for LC U/S by emergency physicians and residents |  | 365 days | 
| difference in diagnostic time interval for patients grouped by pre-test probability |  | 3 days | 
| number of return visits for formal ultrasound imaging |  | 3 days | 
| number of patients receiving empirical anticoagulation while formal ultrasound imaging is pending |  | 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
deep vein thrombosis, venous thromboembolic disorders, diagnostic ultrasound
Erenumab For Treatment of Hemicrania Continua

Study Overview
=================
Brief Summary
-----------------
This research is being conducting to learn if the study drug erenumab is successful in treating hemicrania continua. The study is also evaluating the safety and tolerability of erenumab in individuals being treated for hemicrania continua.

Official Title
-----------------
Erenumab For Treatment of Hemicrania Continua

Conditions
-----------------
Hemicrania Continua

Intervention / Treatment
-----------------
* Drug: Erenumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Adults over the age of 18-66 At least a 12 month history of hemicrania continua (unremitting subtype) according to International Classification of Headache Disorders, 3rd Edition (ICHD-3)1 Previous or current complete response to indomethacin Stable preventive treatment for at least 2 months and no anticipated need to adjust/add current headache prevention treatment Exclusion Criteria Nonresponse to a therapeutic dose of indomethacin for hemicrania continua when used for at least 1 week Pregnant or lactating subjects Use of barbiturate or opioid >6 days per month; history of chronic migraine History of previous trigeminal-autonomic cephalalgia History within previous 2 months of interventional procedure for headache (occipital or other extracranial nerve block, sphenopalatine ganglion block, cervical facet block, facet rhizotomy) History of cranial nerve/rhizolysis Botulinumtoxin injection with previous 4 months Parenteral infusion of or oral corticosteroid use for more than 3 days within 4 weeks prior to screening phase

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 66 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with Erenumab<br>Subjects diagnosed with hemicrania continua will receive single dose of Erenumab | Drug: Erenumab<br>* 140 mg of erenumab via subcutaneous injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache Days | The total number of days per month (28 days) with headache of any kind/severity | 4 weeks post erenumab treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Migraine Days | Total number of days per month (28 days) with migraines | 4 weeks post erenumab treatment | 
| Headache Freedom | Total number of days per month (28 days) with complete headache freedom | 4 weeks post erenumab treatment | 
| Remission Rate | Number of participants who do not have any occurrence of headache | 4 weeks post erenumab treatment |
Effects of Prevena Therapy on Obese and or Diabetic Patients With Surgical Groin Sites

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the effects of Prevena therapy on decreasing groin surgical site infections in patients who are obese and /or diabetic having vascular surgery.

Detailed Description
-----------------
Patients who are obese and/or diabetic may have poor surgical healing and infection rates higher. The PREVENA therapy will be used to evaluate possible reduction of infection rates in this patient population

Official Title
-----------------
EFFECTS OF PREVENA THERAPY ON REDUCTION OF GROIN SURGICAL SITE INFECTIONS IN OBESE PATIENTS UNDERGOING VASCULAR SURGERY

Conditions
-----------------
Obesity, Diabetes, Peripheral Vascular Disease

Intervention / Treatment
-----------------
* Device: Prevena vac


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects over 18 years old obese (BMI > 30) and or diabetic Exclusion Criteria: current infected surgical field, hemodialysis, immunosuppressive therapy, allergy to adhesive, sensitivity to silver

Ages Eligible for Study
-----------------
Minimum Age: 18 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: negative pressure dressing vs. standard of care<br>single arm study- randomized Prevena vac or standard of care | Device: Prevena vac<br> <br> * Other names: randomized 1:1 negative pressure dressing vs. standard of care;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with infections | reduction of 30 day surgical site infection by evaluating infection rates in obese, diabetic patients who were randomized to Prevena Vac vs. standard of care | 30 day post surgical procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| infection rates | reduction of 1 year graft infection in prosthetic grafts and reduction of secondary hospitalizations for infection.Patients will be followed through 1 year to measure results of infection rates and secondary hospitalization related to infection | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
groin incisions
Epidural Catheter Location by Epidural Pressure Waveform

Study Overview
=================
Brief Summary
-----------------
The aim of this preliminary study was to evaluate the new CompuFlo instrument which allows pulsatile waveform recordings.

Detailed Description
-----------------
30 epidural catheters previously successfully used for obstetric anesthesia or analgesia and about to be removed were tested. All patients were given 5 mL 2% lidocaine to test the catheter before its removal. After priming with 5 mL saline, the catheter was connected to CompuFlo to record the occurrence of pulsatile waveforms and/or their disappearance during its removal. The epidural catheter was marked at the skin level to record the distance between the skin at the time of measurements. The power analysis required a sample of 30 observations to set 80% test power and 95% significance level.

Official Title
-----------------
Confirmation of Epidural Catheter Location by Epidural Pressure Waveform Recordings by the CompuFlo Epidural Instrument

Conditions
-----------------
Anesthesia, Local

Intervention / Treatment
-----------------
* Device: CompuFlo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obstetric patients Must have an epidural catheter Exclusion criteria • Non-obstetric patients

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: CompuFlo|After priming with 5 mL saline, the catheter was connected to CompuFlo to record the occurrence of pulsatile waveforms and/or their disappearance during its removal|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pulsatile waveforms observation (presence or absence) | The epidural catheter was considered to be in the epidural space if the appearance of pulsatile waveforms were observed, and confirmed by the occurrence of L2-3 sensory block after the test dose. The disappearance of the pulsatile waveforms when the catheter was extracted from the epidural space was also noted. | 30 minutes |
Lumbar Infiltration With Steroids - Effects on Pain Reduction

Study Overview
=================
Brief Summary
-----------------
Questionnaire for patients who got a lumbar infiltration in our clinic. The patients will have to answer questions concerning their pain. (The lumbar infiltration itself is not part of this study)

Detailed Description
-----------------
Questionnaire are given to patients who got a lumbar infiltration in our clinic of rheumatology. These patients will have to answer questions concerning their pain. (The lumbar infiltration itself is not part of this study).

Official Title
-----------------
Lumbar Infiltration With Steroids - Effects on Pain Reduction

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Other: survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients who got a lumbar infiltration in our clinic. Exclusion criteria: Infiltration of thoracal or cervical spine.

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: survey|no intervention. Only questionnaire after lumbar infiltration with steroids - effects on pain reduction|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain reduction | on visual analog scale | week 1 and 3; month 3, 6, 12 |
Gas Transfer on ILA-Activve

Study Overview
=================
Brief Summary
-----------------
Oxygenatuion and decarboxylation during different settings (steps of blood flow and sweep gas flow) of extracorporeal gas exchange by ILA Activve using a jugular 22French double lumen cannula are measured.

Official Title
-----------------
Efficiency of Gas Exchange Using a Miniaturized Pump Driven Veno-venous Extracorporeal Gas Exchange Device (ILA-Activve)

Conditions
-----------------
Hypercapnia

Intervention / Treatment
-----------------
* Device: Change of blood flow or sweep gas flow ( ILA Activve)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient on ILA Activve Controlled mechanical ventilation No spontaneous breathing Exclusion Criteria: - Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 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: Extracorporeal CO2 elimination by ILA Activve(R)<br> | Device: Change of blood flow or sweep gas flow ( ILA Activve)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood gas analysis |  | Changes after every 15 min. of each setting (13 settings leading to 195 min. altogether) |
Validation of a Predictive Model to Estimate the Risk of Conversion to Clinically Significant Macular Edema and/or Vision Loss in Mild Nonproliferative Diabetic Retinopathy in Diabetes Type 2

Study Overview
=================
Brief Summary
-----------------
This project aims to validate a predictive model of diabetic retinopathy progression to clinically significant macular edema (CSME) needing photocoagulation and/or vision loss. The Coimbra Predictive Model (CPM), based on retinal thickness, microaneurysms number, HbA1C and LDL levels, established on a set of 52 diabetic patients, will be tested on a population of 400 patients/eyes to be enrolled into the study. These patients will perform 2 visits at 6-month interval (V0 and V6) to classify each patient into one of the 3 previously established phenotypes. Two years after (V24) patients will be reexamined. The occurrence of end-points, achieved by the patients, are expected to validate our predictive model.

Official Title
-----------------
Validation of a Predictive Model to Estimate the Risk of Conversion to Clinically Significant Macular Edema and/or Vision Loss in Mild Nonproliferative Diabetic Retinopathy in Diabetes Type 2

Conditions
-----------------
Diabetic Retinopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes type 2 according to 1985 WHO criteria. Age between 35 and 75 years. Mild non-prolipherative retinopathy (based on ETDRS criteria) Best Corrected Visual acuity >20 /25 Refraction with a spherical equivalent less than 5 Dp. Inform consent Exclusion Criteria: Cataract or other eye disease that may interfere with fundus examinations Glaucoma Vitreous syneresis or posterior vitreous detachment Other retinal vascular disease Recent intraocular surgery Previous laser therapy Dilatation of the pupil < 5 mm

Ages Eligible for Study
-----------------
Minimum Age: 35 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 |
| --- | --- |
| MNPDR<br>Type 2 diabetic patients with Mild non-prolipherative retinopathy. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CSME needing Photocoagulation |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vision Loss |  | 24 months |