linjc16/ctgov huggingface dataset:
Endoscopic Stenting in Crohn Related Strictures

Study Overview
=================
Brief Summary
-----------------
Prospective, randomized-controlled trial comparing self-expandable metal stent versus ballon dialtation only for the endoscopic treatment of benign strictures related to Crohn´s disease.

Official Title
-----------------
Endoscopic Stenting in Crohn Related Strictures

Conditions
-----------------
Intestinal Strictures Related to Crohn´s Disease

Intervention / Treatment
-----------------
* Procedure: Self-expandable metal stent
* Procedure: Balloon dilatation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Benign high-grade Crohn stricture Exclusion Criteria: Unwillingness to participate Planned surgery High risk for bleeding

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stent<br> | Procedure: Self-expandable metal stent<br>* Endoscopic stenting of intestinal stricture related to Crohn´s disease<br>|
| Active Comparator: Dilatation<br> | Procedure: Balloon dilatation<br>* Endoscopic balloon dilatation of intestinal stricture related to Crohn´s disease<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success rate |  | Peroperative | 
| Adverse event rate |  | Within 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical success rate |  | 24 months |
Effect of Surgical Wound Infection on Health

Study Overview
=================
Brief Summary
-----------------
A surgical site infection (SSI) is an infection that occurs after surgery in the part of the body

Detailed Description
-----------------
Morbidity and mortality were associated with increase of surgical site infections (SSIs).Besides, it was a financial burden and negatively impact of SSIs on patient quality of life (QoL).

Official Title
-----------------
Effect of Surgical Wound Infection on Health of Women

Conditions
-----------------
Infection

Intervention / Treatment
-----------------
* Other: To evaluate the effect of wound infection on costs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: wound who had infection post surgery Exclusion Criteria: women who had no infection

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 42 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: To evaluate the effect of wound infection on costs|the degree of costs that is required for trating wound infection|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| What is the effect of surgical site infection on health care cost | how much does it cost for wound infection | within a month |
Leukotriene Receptor Antagonists or Steroids in Pre-School Asthma

Study Overview
=================
Brief Summary
-----------------
Explorative comparison of montelukast with inhaled steroids (fluticasone) to estimate responder profiles, in terms of symptom scores, rescue medication, increase of FEV1, in correlation to presence of allergy, bronchial hyperreactivity (PD20), exhaled NO, excretion of leukotrienes, response to RABA and laboratory parameters in patients with pre-school asthma i.e. asthma phenotypes.

Official Title
-----------------
A Randomised Controlled Open-Label Phase IV Mono Centre Study to Compare the Response Profiles of Montelukast Versus Fluticasone in Children With Pre-School Asthma

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

Intervention / Treatment
-----------------
* Drug: Montelukast
* Drug: Fluticasone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients age 4 -6 years Diagnosis of mild intermittent bronchial asthma (Step I-II) in the past 6 - 12 months as stated by the investigator: Use of inhaled beta-2-agonists < 1/week (max 3 puff /d) Exacerbation-free interval > 4 weeks prior to visit 1 The written informed consent of parents after received written and oral information about the aim, purpose and risks of the study must be present Exclusion Criteria: Asthma severity ≥ Step 2 Severe concomitant diseases Suspected non-compliance age below 4 and age above 7 years last study participation < 30 days

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 6 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Montelukast | Drug: Montelukast<br>* Intake of Montelukast<br>|
| Active Comparator: 2<br>Fluticasone | Drug: Fluticasone<br>* Intake of Fluticasone<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy variable is the number of responders with a very good asthma symptom control defined as requiring no rapid acting beta agonist (RABA) between the 2. and 6th week of intervention (end of trial) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of patients requiring at least five times RABA between the 2. and 6th week, the number of patients with an increase of FEV1 7.5%, the symptom score, symptom free days, rescue medication, presence of allergy RAST > 2, concentration of eNO, PD20 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pre-School Asthma, Responder Profiles, Fluticasone, Montelukast, Leukotriene, Children with Pre-School Asthma
Diagnostic Value of Procalcitonin in Patients With Acute Appendicitis

Study Overview
=================
Brief Summary
-----------------
The values of laboratory examinations which are useful for the diagnoses of acute appendicitis are white blood cell count (WBC), C-reactive protein (CRP) and erythrocyte blood sedimentation rate (ESR). Another laboratory value which has recently received considerable attention for the early diagnosis of bacterial infection and sepsis is pro-calcitonin (PCT). In recent studies it has been clearly shown that PCT is one of the most important biochemical indicators which closely correlates with the severity of inflammatory host response to microbial infections. Aim of this open, prospective study is therefore to investigate if PCT has an accurate diagnostic value for the diagnosis of acute appendicitis.

Official Title
-----------------
A Prospective Study Investigating the Diagnostic Value of Procalcitonin in Patients With Acute Appendicitis

Conditions
-----------------
Appendicitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of appendicitis Exclusion Criteria: Antibiotic therapy Infection at other body sites Age < 14 years Appendectomy in the medical history

Ages Eligible for Study
-----------------
Minimum Age: 14 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diagnostic Appendicitis, Procalcitonin
A Study of Mircera for the Treatment of Anemia in Dialysis Patients

Study Overview
=================
Brief Summary
-----------------
This study will assess the efficacy and safety of Mircera given intravenously in the treatment of renal anemia in chronic kidney disease patients on dialysis who are not currently receiving epoetin or any other erythropoietic substance. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

Official Title
-----------------
A Randomized, Open-label Study of the Effect of Intravenous Mircera on Hemoglobin Level/Correction in Dialysis Patients With Chronic Kidney Disease

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Drug: epoetin
* Drug: methoxy polyethylene glycol-epoetin beta [Mircera]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients >=18 years of age; chronic renal anemia; dialysis therapy for at least 2 weeks before screening. Exclusion Criteria: women who are pregnant, breastfeeding or using unreliable birth control methods; administration of any investigational drug within 4 weeks before screening.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: methoxy polyethylene glycol-epoetin beta [Mircera]<br>* 0.4 micrograms/kg iv (starting dose) once every 2 weeks<br>|
| Active Comparator: 2<br> | Drug: epoetin<br>* 3 times a week iv, as prescribed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin response rate |  | Weeks 1-24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hb over time, time to target Hb response, incidence of RBC transfusions. Vital signs, ECG, AEs, laboratory values\n |  | Throughout study |
Infant Nutrition: Evaluation of an Educational Touchscreen Computer Program

Study Overview
=================
Brief Summary
-----------------
The investigators are recruiting participants for a randomized controlled trial to evaluate the usability and educational value of a nutrition education touchscreen computer program targeting Spanish-speaking Latina caregivers of children 2 and under. Participants will be randomized to the intervention group - use the computer program and the control group - do not use the program. They will be asked basic demographic questions, nutrition knowledge questions and computer users will be asked usability questions. Objectives are Evaluate the subjective and objective usability of the touchscreen computer. Determine whether health knowledge on nutrition topics is enhanced through the use of the computer modules.

Official Title
-----------------
Infant Nutrition: Evaluation of an Educational Touchscreen Computer Program for Use in a Spanish-speaking Population of Caregivers of Young Children (APA Phase II)

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Other: Computer Use


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Have a child 2 and under in their care 2. Consider themselves Latina 3. Are Spanish-speaking Exclusion Criteria: Exclude if child has major medical issues interfering with feeding

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: Prevention
Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Computer Use<br>Participants use the computer with the infant/toddler nutrition/feeding education modules | Other: Computer Use<br>* Participants use the computer with the 5 modules on infant/toddler feeding/nutrition<br>|
| No Intervention: Control<br>Only answers survey questions. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
COvera in BRAnch Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of the registry is to evaluate the peri-operative and short-, mid- and long-term outcomes of the Bard Covera Plus (Tempe, Arizona, USA) for the treatment of atherosclerotic aorto-iliac aneurysm in combination with a multibranched endograft

Official Title
-----------------
A Physician-initiated, Multicentre, Ambispective, Observational Registry of Patients Undergoing Complex Aortic Procedures With the Use of the Bard Covera Plus (Tempe, Arizona, USA) Covered Self-expandable Stents

Conditions
-----------------
Aneurysm

Intervention / Treatment
-----------------
* Device: covered stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients ≥18 years Patients who underwent/will undergo a complex aortic procedure with the use of a Covera Plus covered stent graft as a bridging stent, in the centres involved in this Registry Subject has consented for study participation and signed the approved Informed Consent Exclusion Criteria: Bleeding diathesis or coagulopathy Patients with active systemic or cutaneous infection or inflammation Patients who are pregnant or lactating Patient younger than 18 years of age Patients who did not receive treatment using a Covera Plus covered stent graft.

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 |
| --- | --- |
| Covera Plus<br> | Device: covered stent<br>* atherosclerotic aorto-iliac aneurysm<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| technical success | freedom from type I or type III endoleak, stenosis/occlusion, dislocation/kinking | 30 days | 
| Branch instability | freedom from branch-related complications | 30 days | 
| Primary clinical success | freedom from death, type I/III endoleak, graft infection/thrombosis, aneurysm expansion and/or rupture, conversion to open repair, or new treatment-related thoraco-abdominal pathologies | 30 days |
Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome

Study Overview
=================
Brief Summary
-----------------
This study will examine the efficacy and safety of tivanisiran sodium eye drops versus vehicle after a 2-week run-in phase when dosed once daily for 3 months in subjects with signs and symptoms of dry eye disease (DED) due to Sjögren's Syndrome.

Official Title
-----------------
Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome

Conditions
-----------------
Dry Eye Disease, Sjögren Syndrome

Intervention / Treatment
-----------------
* Drug: Tivanisiran sodium ophthalmic solution
* Drug: Vehicle ophthalmic solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is a male or a female aged ≥ 18 years Have given their written consent to participate in the study Use of artificial tears (AT), autologous serum or specific dry eye medications during the last 6 months prior to the selection Willing to not use AT or autologous serum for the study duration VAS scale for Dry Eye Symptom Score ≥ 40 Total CFS ≥ 5 Schirmer's test with anesthesia < 10 mm/5min Patients with Sjögren Syndrome Exclusion Criteria: Any concomitant treatment or prior ocular procedure or surgery, or alteration of the dose of systemic medications at the time of entry into the study Use of contact lenses during the study Significant Eye diseases according to investigator's opinion

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tivanisiran sodium ophthalmic solution<br> | Drug: Tivanisiran sodium ophthalmic solution<br>* 1 drop in the affected eye(s) once daily<br>|
| Placebo Comparator: Vehicle ophthalmic solution<br> | Drug: Vehicle ophthalmic solution<br>* 1 drop in the affected eye(s) once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Corneal Fluorescein Staining (CFS) scale [0-3]. Higher scores mean disease worsening. |  | 85 days | 
| Change from baseline in Dry Eye Symptom scale [0-100]. Higher scores mean disease worsening. |  | 85 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oligonucleotide, siRNA, keratoconjunctivitis sicca, SYL1001
Effects of Mixed Nut Consumption on Satiety and Weight Management

Study Overview
=================
Brief Summary
-----------------
The first goal of the proposed study is to determine acute and long-term effects of mixed nuts (almonds, hazelnuts, pecans, pistachios, walnuts, and peanuts) on metabolic parameters and weight management. While numerous studies have shown the beneficial effects of nuts on promoting negative energy balance and weight loss, mechanistic studies exploring how the inclusion of nuts in the diet promotes a negative energy balance and weight loss have not been conducted. The second goal is to determine the mechanisms by which mixed nut consumption regulates of food intake and body weight.

Official Title
-----------------
Effects of Mixed Nut Consumption on Satiety and Weight Management

Conditions
-----------------
Satiety

Intervention / Treatment
-----------------
* Other: Pretzels
* Other: Mixed nuts


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-55 years old BMI 27-40 Exclusion Criteria: Smoker Pregnant woman Required dietary supplement use Required medication of metabolic disorders Allergy to nuts or gluten

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pretzels<br> | Other: Pretzels<br>* Subjects consume 240 kcal of pretzels daily for 16 weeks.<br>|
| Experimental: Mixed nuts<br> | Other: Mixed nuts<br>* Subjects consume 240 kcal of mixed nuts daily for 16 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Satiety | Hunger feeling (appetite) will be examined using visual analog scale (0-10): 0 least and 10 greatest | 0, 20, 40, 60, 90 and 120 minutes post snack consumption | 
| Change of glucose level | Glucose level will be examined using glucose analysis | Baseline, 40 minutes post snack consumption, and 8 weeks and 16 weeks post daily consumption | 
| Change of insulin level | Insulin level will be examined using an ELISA biochemical method | Baseline, 40 minutes post snack consumption, and 8 weeks and 16 weeks post daily consumption | 
| Change of cholesterol levels | Cholesterol levels will be examined using a biochemical method | 8 weeks and 16 weeks post daily consumption | 
| Change of Lp(a) | Lp(a) levels will be examined using an ELISA biochemical method | 8 weeks and 16 weeks post daily consumption | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of microbiome | Diversity of microbiome will be analyzed in fecal samples | 8 weeks and 16 weeks post daily consumption |
Effect of Double Tourniquet Technique on Ultrasonographic View of Forearm Veins

Study Overview
=================
Brief Summary
-----------------
Vein compressibility will be assessed after light pressure applied with the ultrasound probe. Vein compressibility will be graded as 3 (100% compressed), 2 (50-100 compressed), and 1 (less than 50% compressed). After baseline measurements were taken, a proximal tourniquet will be applied to mid-arm. Repeated measurements of depth, width, and compressibility will be taken one minute after the tourniquet was applied. Same measurements will be repeated again with second tourniquet applied 1 cm distal to the first tournique.

Official Title
-----------------
Effect of Double Tourniquet Technique on Width and Compressibility of Superficial Veins of Forearm

Conditions
-----------------
Superficial Forearm Veins Compressibility and Width

Intervention / Treatment
-----------------
* Device: Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers aged 18-60 years will participate in the study Exclusion Criteria: patients with dialysis shunts, previous mastectomy on the examined side, fracture , skin lesion , burn or edema on the examined side

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Ultrasound|Checking vein width snd copression using US|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Superficial forearm vein width and compressibility under ultrasonography | Ultrasonography is used to measure forearm superficial veins width and compressibility | 1 minute after application of one proximal tourniquet | 
| Superficial forearm vein width and compressibility under ultrasonography | Ultrasonography is used to measure forearm superficial veins width and compressibility | 1 minute after application of two proximal tourniquet 1 cm apart |