linjc16/ctgov huggingface dataset:
URO-BCG-4 : Bladder Tumors Immunotherapy

Study Overview
=================
Brief Summary
-----------------
Evaluation of maintenance BCG immunotherapy (dose 27 mg) in superficial bladder tumors. Two randomized arms (every 3 or 6 months) will be studied for a population of 300 patients.

Detailed Description
-----------------
BCG maintenance immunotherapy 1/3 dose : 27 mg two randomized arms : 3 or 6 months for 36 months clinical side effects according to OMS score efficacy regarding recurrence : cytology and cystoscopy PSA, leucocyturia and N-ramp gene evaluation

Official Title
-----------------
Clinical Evaluation of Maintenance BCG Immunotherapy in Superficial Bladder Tumors

Conditions
-----------------
Bladder Cancer

Intervention / Treatment
-----------------
* Biological: bladder tumor recurrence


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ta and T1 bladder tumors Exclusion Criteria: BCG contra-indications
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Daily instillation of BCG for 3 weeks then every 6 months<br>Effect of daily instillation of BCG (27 mg) for 3 weeks then one instillation of BCG (27 mg) every 6 months for 36 months on bladder tumor recurrence | Biological: bladder tumor recurrence<br>* bladder tumor recurrence assessed by clinical and biological exams<br>|
| Daily instillation of BCG for 2 weeks then every 3 months<br>Effect of daily instillation of BCG (27 mg) for 2 weeks then one instillation of BCG (27 mg) every 3 months for 36 months on bladder tumor recurrence | Biological: bladder tumor recurrence<br>* bladder tumor recurrence assessed by clinical and biological exams<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumoral response | Tumoral response assessed at M36 | Month 36 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumoral response | Tumoral response assessed at M24 | Month 24 |
The Effect of Dexmedetomidine on Propofol Requirement for Insertion of Laryngeal Mask Airway

Study Overview
=================
Brief Summary
-----------------
Propofol frequently used as an inducting medication for insertion Laryngeal mask airway(LMA). But propofol alone can be not sufficient for inhibiting upper airway reflex and also result in cardiovascular suppression under enough amount. Dexmedetomidine is a selective alplh2 receptor agonist with analgesic and sedative effects but sparing respiratory function. Therefore propofol combined with dexmedetomidine induction could be more effective in preserve respiration under same condition for LMA insertion than propofol alone. In this study, the investigators investigate the clinical dose of propofol for LMA insertion with premedication of dexmedetomidine, and evaluate the effect of dexmedetomidine.

Official Title
-----------------
The Effect of Dexmedetomidine on Propofol Requirement for Insertion of Laryngeal Mask Airway

Conditions
-----------------
Precedex Effect to Propofol Requirement

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine
* Drug: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients for surgery not exceed more than 2 hours requiring general anesthesia Exclusion Criteria: history of gastroesophageal reflux High grade obesity Predicted diffiicult airway

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 60 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control<br>After preoxygenation for 3 minutes, normal saline would be injected to patient for 10 minute. First, 1% lidocaine 3 ml were given for reducing injection pain of propofol and the settled amount of propofol was injected during 15 seconds. After 90 seconds, other anesthesiologist who did'nt know the injected drug tried to insert LMA. | Drug: Normal saline<br> <br> |
| Experimental: dexmedetomidine<br>After preoxygenation for 3 minutes, dexmedetomidine would be injected to patient for 10 minute. First, 1% lidocaine 3 ml were given for reducing injection pain of propofol and the settled amount of propofol was injected during 15 seconds. After 90 seconds, other anesthesiologist who did'nt know the injected drug tried to insert LMA. | Drug: Dexmedetomidine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fail or success for Laryngeal Mask Airway (LMA) insertion | Failure for LMA insertion is defined if there is a difficulty for mouth opening or active movement of four limbs or head. Success is smooth LMA insertion without any movement | During inserting LMA and up to 5 seconds after LMA inserion |
Post Approval Study of the Eversense® Continuous Glucose Monitoring

Study Overview
=================
Brief Summary
-----------------
A Post Approval Study to Evaluate the Long-term Safety and Effectiveness of the Eversense® Continuous Glucose Monitoring (CGM) System over repeat insertion and removal cycles and to demonstrate the long-term safety of the Eversense® CGM System

Detailed Description
-----------------
The purpose of this post-approval study (PAS) is to provide long-term safety and effectiveness of the Eversense CGM System (PMA Application P160048) in the post-market setting. In the premarket setting, the PRECISE II and PRECISION studies demonstrated safety and accuracy of the CGM system in estimating blood glucose levels compared to reference blood glucose analyzer levels to 90 days. The PROMISE study demonstrated safety and accuracy of the CGM system up to 180 days. This PASstudy will provide safety and effectiveness data up to 27 months of repeated use.

Official Title
-----------------
A Post- Approval Study to Evaluate the Long-term Safety and Effectiveness of the Eversense® Continuous Glucose Monitoring (CGM) System

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

Intervention / Treatment
-----------------
* Device: Eversense® CGM system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has diabetes Subject is greater than 18 years of age Exclusion Criteria: Subject is critically ill or hospitalized Subject has a known contraindication to dexamethasone or dexamethasone acetate Subjects requiring intravenous mannitol or mannitol irrigation solutions Female subjects who are pregnant, planning on becoming pregnant or nursing Subjects on hybrid closed loop systems or closed loop systems Subjects on other CGM systems

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Continuous Glucose Monitoring Device<br> | Device: Eversense® CGM system<br>* Continuous Glucose monitoring device that lasts up to 90 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of procedure-related adverse events | The primary safety endpoint is the Incidence of the composite of infection, secondary procedures to remove the sensor, or procedure-related adverse events of at least moderate severity | 12 months | 
| Time in Range | The primary effectiveness endpoint is Time in Range, which is defined as glucose values between 70mg/dL and 180 mg/dL, at 12 months post first sensor insertion compared to first month post first sensor insertion | 12 months |
First-in-Human Single Ascending and Multiple Dose of GLPG0259

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) and multiple (MD) oral dose of GLPG0259 compared to placebo. Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0259 after single and multiple oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.

Official Title
-----------------
Double Blind, Placebo-controlled Trial for the Assessment of Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Single Ascending and Multiple Oral Doses of GLPG0259 in Healthy Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: GLPG0259
* Drug: placebo
* Drug: GLPG0259
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy male, age 18-50 years BMI between 18-30 kg/m², inclusive. Exclusion Criteria: significantly abnormal platelet function or coagulopathy smoking drug or alcohol abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>single ascending doses | Drug: GLPG0259<br>* single ascending doses, oral solution<br>|
| Placebo Comparator: 2<br>single dose placebo | Drug: placebo<br>* single dose, oral solution<br>|
| Experimental: 3<br>multiple dose, 5 days, oral solution | Drug: GLPG0259<br>* multiple dose, oral solution, 5 days<br>|
| Placebo Comparator: 4<br>multiple dose, 5 days, oral solution | Drug: placebo<br>* oral solution, 5 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of single and multiple dosing |  | up to 10 days postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of single and repeated doses |  | up to 10 days postdose | 
| Exploratory evaluation of TNF-alpha and IL6 in whole blood |  | up to 12 hours postdose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety, Tolerability, Pharmacokinetics
Food Groups Associated With Anaemia in Pregnant Women

Study Overview
=================
Brief Summary
-----------------
This study investigates the association between locally consumed food items with anemia among pregnant women, in Addis Ababa city, Ethiopia.

Detailed Description
-----------------
Prevention of anemia among women, particularly pregnant women, is a priority nutrition agenda in Ethiopia. Anemia is a significant contributor to poor pregnancy outcomes, including low birth weight and maternal mortality. Anemia is of multiple influences, which in most of the cases include dietary factors. Consumption food items rich in iron and other nutrients involved in red blood cell production promotes optimal hemoglobin level. Dark green leafy vegetables, meat, and beans are some of the food groups reported to be associated with lesser risk of anemia. Studies on the relation of indigenous food items with health outcome are limited in developing countries. For example, teff, consumed only in Ethiopia and parts of Eritrea, is traditionally believed to be protective of anemia because of its high iron content, but Khat chewing, a pervasive social practice in Ethiopia, has been associated with restrictive eating pattern and anemia. In this study, the association of locally consumed food groups with anemia was investigated among pregnant Ethiopian women.

Official Title
-----------------
The Relation of Locally Available Food Items With Anemia Status Among Pregnant Women in Ethiopia

Conditions
-----------------
Anemia, Dietary Habits, Food Habits

Intervention / Treatment
-----------------
* Dietary Supplement: Food groups consumed


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women Age 18 years and above Residence in Addis Ababa city Exclusion Criteria: Serious medical illness

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Anemic<br>Hemoglobin <11 g/l | Dietary Supplement: Food groups consumed<br> <br> |
| Non-anemic<br>Hemoglobin 11 g/l (and above) | Dietary Supplement: Food groups consumed<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food items/groups association with anemia | Relation of food groups with anemia risk | October 2015 to February 2016 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reproductive factors associated with anemia | Relation of reproductive and obstetrics history with anemia | October 2015 to February 2016 | 
| Sociodemographic and economic factors association with anemia | Relation of socioeconomic factors with anemia | October 2015 to February 2016 |
Assessing Effectiveness of Adalimumab for Treating Ulcerative Colitis in Real Life Conditions

Study Overview
=================
Brief Summary
-----------------
This study assesses the long?term effectiveness of adalimumab in subjects starting a treatment for ulcerative colitis in real life conditions, namely to describe the time to loss of clinical benefit in a time to event approach.

Official Title
-----------------
Assessing Effectiveness of Adalimumab for Treating Ulcerative Colitis in Real Life Conditions

Conditions
-----------------
Ulcerative Colitis (UC)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suffering from ulcerative colitis Naïve from Adalimumab Starting a treatment with adalimumab Capable of and willing to grant authorization for use/disclosure of data collected Able to read, understand, and complete patients questionnaires Exclusion Criteria: - None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Subjects starting/ receiving adalimumab<br>Subjects starting/ receiving Adalimumab for UC | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to loss of clinical benefit | Loss of clinical benefit will be defined as one of the following: loss of efficacy leading to adalimumab discontinuation or introduction/reinforcement of aminosalicylates, 6-mercaptopurine, or azathioprine, introduction or reinforcement of corticosteroids (any route), UC-related surgery, discontinuation of adalimumab due to adverse event, death. | Up to Month 120 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline (Month 0) in Steroid-free remission | Steroid- free remission is defined as partial Mayo score <= 2 with no subscore >1 and no daily intake of prednisone. | From Month 0 to Month 120 | 
| Change from Baseline (Month 0) in Clinical Remission | Clinical remission is defined as partial Mayo score <= 2 with no subscore >1 | From Month 0 to Month 120 | 
| Change from Baseline (Month 0) in Clinical Response | Clinical response is decrease in partial Mayo score >= 3 points and >= 30% from baseline plus a decrease in rectal bleeding subscore >= 1 or an absolute rectal bleeding subscore <= 1. | From Month 0 to Month 120 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adalimumab, Ulcerative Colitis, SOTHIS, Effectiveness
Intubation of Patients With Odontogenic Abcesses

Study Overview
=================
Brief Summary
-----------------
This study is a comparison of two techniques for endotracheal intubation (Glidescope versus Macintosh) in patients with odontogenic abscesses.

Detailed Description
-----------------
Patients with odontogenic abcesses have to be treated by surgical drainage of the abscess under general intubation with endotracheal intubation. Because of a limited mouth opening and swelling within the oral cavity, intubation can be difficult and sometimes impossible with conventional direct laryngoscopy. Therefore, alternative techniques are desirable. We want to compare the success rate of intubation in these patients using the Glidescope technique vs. conventional Macintosh technique.

Official Title
-----------------
Intubation of Patients With Odontogenic Abcesses Glidescope vs. Macintosh Technique

Conditions
-----------------
Odontogenic Abscess

Intervention / Treatment
-----------------
* Device: Glidescope
* Device: Macintosh laryngoscope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients have to have an abscess which has to be treated surgically. Mouth opening (Inter-incisor gap) has to be less than 3.5 cm and more than 1.4 cm. Exclusion Criteria: Age under 18 years.

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 |
| --- | --- |
| Glidescope<br>Patients intubated with the Glidescope technique | Device: Glidescope<br>* Patients are to be intubated using the Glidescope technique<br>|
| Macintosh<br>Patients intubated via the conventional direct laryngoscopy with a Macintosh laryngoscope | Device: Macintosh laryngoscope<br>* Patients are to be intubated using direct laryngoscopy with a Macintosh laryngoscope<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of endotracheal intubation |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time for intubation |  | 18 months | 
| View of the laryngeal entrance (according to the classification of Cormack and Lehane) |  | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intubation, Glidescope, Macintosh, Abscess, Difficult intubations in patients with odontogenic abscesses
Zilver® PTX® V Clinical Study

Study Overview
=================
Brief Summary
-----------------
The Zilver® PTX® V Clinical Study is a post-market clinical trial required by the US FDA to provide continued evaluation of the safety and effectiveness of the Zilver PTX Drug-Eluting Peripheral Stent in treatment of narrowing of the femoropopliteal arteries.

Official Title
-----------------
Zilver® PTX® Drug-Eluting Peripheral Stent Post-Approval Study

Conditions
-----------------
Peripheral Arterial Disease

Intervention / Treatment
-----------------
* Device: Zilver® PTX® Drug-Eluting Peripheral Stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has signed and dated the informed consent. Patient has symptomatic vascular disease of the native above-the-knee femoropopliteal arteries. Patient agrees to return for the required follow-up assessments. Exclusion Criteria: Patient is < 18 years of age. Patient has significant stenosis of inflow tract not successfully treated before this procedure. Patient lacks at least one patent vessel of runoff with < 50% stenosis throughout its course.

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: Drug-Eluting Stent<br> | Device: Zilver® PTX® Drug-Eluting Peripheral Stent<br>* Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients Without Target Lesion Revascularization (TLR) | A reintervention performed for ≥ 50 % diameter stenosis within ± 5 mm proximal and /or distal to the target lesion after documentation of recurrent clinical symptoms of peripheral arterial disease (PAD) following the initial procedure. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peripheral Vascular Disease, Femoral Artery, Popliteal Artery, Drug-Eluting Stent