linjc16/ctgov huggingface dataset:
Efficacy and Safety of ASF-1096 Cream 0.5% in the Treatment of Discoid Lupus Erythematosus (DLE) Lesions

Study Overview
=================
Brief Summary
-----------------
Lupus Erythematosus (LE) is an autoimmune disorder that includes a broad spectrum of clinical forms. One of these forms, Discoid Lupus Erythematosus (DLE) is a chronic disfiguring disease confined to the skin. The aim of this pivotal trial is to investigate the efficacy and safety of ASF-1096 cream 0.5% in the treatment of patients with DLE or SLE presenting newly developed discoid lesions.

Official Title
-----------------
Efficacy and Safety of ASF-1096 Cream 0.5% in the Treatment of Patients With Newly Developed Discoid Lupus Erythematosus (DLE) Lesions. An International Multi-Centre Clinical Phase 2, Placebo Controlled and Double Blind Proof of Concept Study

Conditions
-----------------
Discoid Lupus Erythematosus

Intervention / Treatment
-----------------
* Drug: ASF 1096 0.5 % cream applied twice daily
* Drug: Cream vehicle for ASF 1096 cream applied twice daily


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A clinical diagnosis of either DLE or SLE Histological results from biopsy confirming the diagnosis (biopsy can be taken at screening) Is prepared to grant authorised persons access to the medical records Has signed informed consent Exclusion Criteria: Has an active skin disease other than DLE or another progressive or serious disease that interferes with the study outcome Has scarring at the target lesion Systemic treatment of SLE

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Drug: ASF 1096 0.5 % cream applied twice daily | Drug: ASF 1096 0.5 % cream applied twice daily<br> <br> |
| Placebo Comparator: 2<br>Cream vehicle for ASF 1096 cream applied twice daily | Drug: Cream vehicle for ASF 1096 cream applied twice daily<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety profile, CLASI score, GIA and GPA. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Discoid lupus erythematosus
An Efficacy and Safety Evaluation of Tiotropium add-on Therapy in Patients With Severe Persistent Asthma

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to examine efficacy and safety of tiotropium compared to plac ebo as add-on therapy in severe asthmatics according to GINA step 4 classification

Official Title
-----------------
A Randomised, Double-Blind, Placebo-Controlled, Crossover Efficacy and Safety Evaluation of 8-Week Treatment Periods of Two Doses [5 Mcg (2 Actuations of 2.5 Mcg) and 10 Mcg (2 Actuations of 5 Mcg)] of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler® as Add-on Therapy in Patients With Severe Persistent Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: tiotropium
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatients of either sex, age 18 - 75 years, with at least a documented 5 year history of asthma, and a current diagnosis of severe, persistent asthma (GINA step 4), smoking history < 10 pack years and >= 1 year smoking cessation; Patients must be symptomatic Exclusion Criteria: Patients with a recent history (i.e., six months or less) of myocardial infarction, who have been hospitalized for heart failure (NYHA class III or IV) within the past year, with any unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year, with malignancy for which the patient has undergone resection, radiation ther apy or chemotherapy within the last five years, who have undergone thoracotomy with pulmonary resection, with moderate to severe renal impairment (creatinine clearance = 50 mL/min)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: tiotropium|nan|
|Drug: placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy endpoint is the FEV1 response (within 3 hours post dosing) determined at the end of the 8-week treatment period |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 and FVC AUC 0-3h (in a subset 0-24h) PEF, use of rescue medication, daytime and nocturnal symptoms etc. |  |  |
Efficacy and Safety of a Purified Standardised Wasp Venom Preparation

Study Overview
=================
Brief Summary
-----------------
The trial is performed to assess efficacy and safety of a purified standardised wasp venom preparation in wasp venom allergy

Official Title
-----------------
Immunotherapy of Wasp Venom Allergy: Comparison of a Purified Preparation to Conventional Aqueous Wasp Venom in an Open Controlled Study

Conditions
-----------------
Allergy

Intervention / Treatment
-----------------
* Biological: wasp venom


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of wasp venom allergy, Positive RAST to wasp venom, Positive skin prick test to wasp venom Exclusion Criteria: Serious chronic diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: wasp venom|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
-----------------
Wasp venom allergy,, specific immunotherapy
Efficacy of Type-5 Phosphodiesterase Inhibitors in Primary and Secondary Pulmonary Hypertension

Study Overview
=================
Brief Summary
-----------------
The aim of this trial is to evaluate the efficacy of type-5 phosphodiesterase inhibitors (sildenafil) in primary and secondary pulmonary hypertension

Detailed Description
-----------------
Patients with primary and secondary pulmonary hypertension will be recruited and admitted to the ICUs of the National Taiwan University Hospital. Each patient will undergo Swan-Ganz catheterization and hemodynamic monitoring during administration of sildenafil. Efficacy of inhaled NO and Iloprost will also be compared.

Official Title
-----------------
Clinical Efficacy of Type-5 Phosphodiesterase Inhibitors (Sildenafil and Vadenafil) in Primary and Secondary Pulmonary Hypertension

Conditions
-----------------
Primary and Secondary Pulmonary Hypertension

Intervention / Treatment
-----------------
* Drug: type-5 phosphodiesterase Inhibitor (Sildenafil)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Patients with primary and secondary pulmonary arterial hypertension - Exclusion Criteria:Unstable patients or patients with allergy to sildenafil

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: type-5 phosphodiesterase Inhibitor (Sildenafil)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean pulmonary artery pressure |  |  | 
| 6 min walking distance |  |  | 
| WHO functional status |  |  | 
| PaO2 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac output |  |  | 
| VO2max |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pulmonary arterial hypertension, type-5 phosphodiesterase Inhibitors, Sildenafil
Survival and Success Rates of 6mm Implants With a Micro-rough Surface After 4.5 - 18.2 Years in Function

Study Overview
=================
Brief Summary
-----------------
In this retrospective study, approximately 60 patients treated with 6mm short implants (Straumann, SLA (sandblasted, large-grit, acid-etched surface), SLActive (sandblasted, large-grit, acid-etched, hydrophilic surface), 4.1 or 4.8 mm in diameter) will be followed for 4.5-18.2 years. Clinical and radiographic parameters will be assessed in a follow-up examination.

Official Title
-----------------
Survival and Success Rates of 6mm Implants With a Micro-rough Surface After 4.5 - 18.2 Years in Function

Conditions
-----------------
Jaw, Edentulous, Partially, Dental Implant Failed, Implant Complication

Intervention / Treatment
-----------------
* Device: Implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Partially or fully edentulous jaw Written informed consent Exclusion Criteria: Pregnant women/lactating women

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 6 mm implants<br>Patients were treated with 6mm short implants (Straumann, SLA, SLActive, 4.1 or 4.8 mm in diameter). | Device: Implantation<br>* Implantation of 6 mm short implants<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant survival rates | Survival rates of short dental implants | 5-18 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic: Annual bone loss | Distance from the implant shoulder to the marginal bone. | 5-18 years | 
| Clinically: modifying risk factors on implant survival and success | Plaque-index | 5-18 years | 
| Clinically: modifying risk factors on implant survival and success | Sulcus bleeding index | 5-18 years | 
| Clinically: modifying risk factors on implant survival and success | Probing depth | 5-18 years | 
| Clinically: modifying risk factors on implant survival and success | Prosthetic reconstruction | 5-18 years | 
| Clinically: modifying risk factors on implant survival and success | Implant position | 5-18 years | 
| Clinically: modifying risk factors on implant survival and success | Crown-to-implant ratio | 5-18 years | 
| Patient reported outcome measures | Visual analog scale (satisfaction between 0 - 100%) | 5-18 years | 
| Patient reported outcome measures | Oral health impact profile | 5-18 years | 
| Implant success rates | Success rates of dental implants. Success rates according to Buser et al. 1990. | 5-18 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Short dental implant, Partially edentulous jaw
Ultraslow SWL Versus Slow SWL for Ureteric Stones With High Attenuation Value

Study Overview
=================
Brief Summary
-----------------
Ultraslow full-power SWL versus slow power-ramping SWL in ureteric stones with high attenuation value

Detailed Description
-----------------
To evaluate the efficacy of ultraslow rate of SWL versus slow rate, power ramping SWL

Official Title
-----------------
Ultraslow Full-power SWL Versus Slow SWL in Stones With High Attenuation Value

Conditions
-----------------
Ureteric Stone

Intervention / Treatment
-----------------
* Procedure: SWL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: single upper ureteric stone less than or equal to 2 cm radio-opaque stone high attenuation value (≥ 1000 HU) stone Exclusion Criteria: Abnormal renal anatomy renal insufficiency solitary kidney coagulopathies uncontrolled hypertension renal artery or aortic aneurysm active urinary tract infection pregnancy severe skeletal malformations (spinal deformity) precluding proper stone localization

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ultraslow shock wave lithotripsy (SWL)<br>SWL at ultraslow rate of 30 SW/min. Power ramping at the first 100 SW from 6 to 18 kv followed by safety pause for two minutes then power ramping from 18 to 22kv during the second 100 SW followed by safety pause for another two minutes. The rest of the session at 22kv (full power). | Procedure: SWL<br>* Shock wave lithotripsy<br>* Other names: ESWL;|
| Active Comparator: Slow power-ramping SWL<br>SWL at a slow rate of 60 SW/min. Power ramping from 6 - 10 kv during the first 500 SW then from 11 - 14 kv during the second 500 SW then from 15 - 18 kv during the following 500 SW then from 19 - 22 kv during the remaining 1000 - 1500 SW. | Procedure: SWL<br>* Shock wave lithotripsy<br>* Other names: ESWL;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stone free rate | Complete clearance of stones in addition to clinically insignificant residual fragments | 3 months following last session of SWL | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications rate | Comparison of rate of complications in both groups | 3 months following last session of SWL | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ureteric stone, SWL, High density stones, Ultraslow SWL, Slow SWL, Ramping, Pause
Mapping the Lumbar Spine Marrow Adiposity

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to describe the change in the percentage of fat in the lumbar spine.

Detailed Description
-----------------
The study of the distribution of bone marrow adiposity is little known in subjects who did not have pathology likely to alter the fat content of the vertebrae. Or that fat content is potentially a reflection of brittle bones (osteoporosis, for example), and deserves to be known because it can be used to normalize the lipid fraction values with respect to age or from the level (L1 , L2, L3, L4 or L5) of the vertebra being studied.

Official Title
-----------------
Mapping the Lumbar Spine Marrow Adiposity

Conditions
-----------------
Marrow Adiposity Lumbar Spine

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutive patients who underwent MRI of the lumbar spine with Sagittal sequenceT1, T2 STIR and IDEAL, good quality, in a clinical setting type back pain, spondylitis research, radicular syndrome ... Examinations conducted between 2014 and 2015 on the same equipment Major patient Having formulated their non-opposition Exclusion Criteria: Previous history of neoplastic disease Vertebral Fracture Pathology reaching the vertebral body detectable by MRI (disc lesion with rearrangements of the endplates (MODIC) Inflammation, Bone tumor, fracture Refusal of participation

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 |
| --- | --- | --- |
| Value of the fat fraction by vertebral level of the lumbar spine, in MRI, measured on the mapping generated by the IDEAL-IQ sequence. |  | 3 months |
Nano Drug Interventional Therapy Using Digital Subtraction Angiography（DSA） for Pancreatic Carcinoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of nano drug interventional therapy using digital subtraction angiography（DSA） for pancreatic cancer. The nano drug is made by mixing Gemzar® with Compound Glycyrrhizin Injection.

Detailed Description
-----------------
By enrolling patients with pancreatic cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of nano drug interventional therapy using digital subtraction angiography（DSA）for pancreatic cancer.

Official Title
-----------------
Nano Drug Interventional Therapy Using Digital Subtraction Angiography（DSA） for Pancreatic Carcinoma：Clinical Trial

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Procedure: interventional therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age:18-80 Karnofsky performance status >60 Diagnosis of pancreatic cancer based on histology or the current accepted radiological measures. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ Will receive interventional therapy Life expectancy: Greater than 3 months Patients' routine blood test, liver function and kidney function have no obvious abnormalities Ability to understand the study protocol and a willingness to sign a written informed consent document Exclusion Criteria: Patients with other primary tumor except pancreatic cancer History of coagulation disorders or anemia

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: interventional therapy|Pancreatic cancer patients received drug interventional therapy using the digital subtraction angiography（DSA）.|

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
-----------------
Pancreatic Cancer, Nano drug
Clinical Presentation and Outcomes in Patients at Risk of Type II Myocardial InfarctioN in the emerGency Department.

Study Overview
=================
Brief Summary
-----------------
Type 2 myocardial infarction has been reported in the Universal Definition of Myocardial Infarction for more than 10 years and most studies resulted in a high mortality rate. However, little to nothing is known for both criteria to define myocardial oxygenation imbalance threshold and the outcome of these patients presenting with myocardial oxygenation imbalance. The aim of this study is to compare the outcome at 6 months for patients admitted in the emergency department with a myocardial oxygenation imbalance, depending on whether a type 2 myocardial infarction occured or not.

Official Title
-----------------
Clinical Presentation and Outcomes in Patients at Risk of Type II Myocardial InfarctioN in the emerGency Department.

Conditions
-----------------
Myocardial Oxygenation Imbalance, Myocardial Infarction

Intervention / Treatment
-----------------
* Other: Follow-up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 years old or older ; At least one condition of myocardial oxygenation imbalance : Oxygen saturation below 90% ; Haemoglobin level below 130 grams/Liter (g/L) for men, 120 g/L for women ; Persistent heart rate over 110 beats per minute, for more than 20 minutes ; Persistent systolic blood pressure below 90 millimeters of mercury (mmHg) for more than 20 minutes despite fluid resuscitation ; Persistent systolic blood pressure over 180 mmHg for more than 20 minutes. Exclusion Criteria: Patient admitted with type 1 myocardial infarction ; Patient presenting a condition for Non Ischemic Myocardial Infarction (pulmonary embolism, acute stroke, acute kidney failure, etc…) Patient who declines to participate; Pregnant or breastfeeding women ; Patient deprived of liberty (inmate, administrative protection)

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 |
| --- | --- |
| Patients<br>Patients admitted in the emergency department presenting a myocardial oxygenation imbalance and are therefore at risk for Myocardial Infarction (MI) type 2. | Other: Follow-up<br>* Onset of Major Adverse Cardiovascular Event of death from all causes will be collected at 3 and 6 months after inclusion.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset of a Major Adverse Cardiovascular Event at 6 months | Onset of a Major Adverse Cardiovascular Event such as: Cardiovascular death Non fatal myocardial infarction Admission for acute heart failure Non fatal stroke | 6 months |