linjc16/ctgov huggingface dataset:
Safety and Performance of the SinuSys Dilation System for Dilation of the Maxillary Sinus Ostium

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess safety and performance of the SinuSys Dilation System for dilation of the maxillary sinus ostium.

Detailed Description
-----------------
A multicenter, single-arm, prospective study conducted to assess the safety and effectiveness of a new osmotically-driven, low-pressure expansion device for dilation of maxillary sinus ostia in patients with (CRS) Chronic Rhinosinusitis

Official Title
-----------------
SinuSys Patency of Maxillary Sinus Ostia Study

Conditions
-----------------
Sinusitis

Intervention / Treatment
-----------------
* Device: SinuSys Dilation System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Diagnosis of chronic maxillary sinusitis Exclusion Criteria: Previous antrostomy Sinonasal tumours Cystic fibrosis History of facial trauma that distorts sinus anatomy and precludes access to the maxillary sinus Pregnant or breastfeeding females Currently participating in another drug or device study

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SinuSys Dilation System<br>Maxillary Sinus Dilation | Device: SinuSys Dilation System<br>* Sinuplasty<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patency of Treated Area |  | Immediately post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patency of Treated Area | Maxillary Sinus Ostia Patency of 33 patients analyzed. | 3 months | 
| Number of Participants With Device-related Adverse Events as a Measure of Safety |  | 3 months | 
| Patency of Treated Area | Maxillary Sinus Ostia Patency of 29 patients analyzed. | 6 months | 
| Patency of Treated Area | Maxillary Sinus Ostia of 27 patients analyzed. | 12 months |
Prevalence and Associated Factors of Functional Gastrointestinal Disorders Among Children

Study Overview
=================
Brief Summary
-----------------
The definition of Functional Gastrointestinal Disorders (FGIDs) has changed over time from the absence of organic disease to a stress-related or psychiatric disorder to a motility disorder, and with Rome III, to a disorder of GI functioning, then Rome iv in 2016 defined FGIDs as : disorders of gut-brain interaction. It is a group of disorders classified by GI symptoms related to any combination of the following: motility disturbance, visceral hypersensitivity,altered mucosal and immune function, altered gut microbiota, and altered central nervous system (CNS) processing. FGIDs are observed in infants and young children worldwide with variable frequency related studies done in variable places around the worled show the following results : the prevalence of FGIDs in Chinese infants and young children is 27.3%.and 40 % in south american infants and 30 % of african infants and 35.1 % of infants presented to tertiary care hospital in Istunbul.Turkey.

Detailed Description
-----------------
The etiology of these disorders remains uncertain and thought to be due to subtle alteration of the normal development or maladaptive behavioral response to a variety of internal or external stimuli .As a group of disorders; FGIDs in young children are a major challenge to the already overstretched pediatric gastroenterology services across the world .Infants and young children with FGIDs visit medical professionals more frequently and experience poor quality of life . In addition, FGIDs in infancy are linked with detrimental repercussions such as maternal depression, poor infant and mother bonding,and poor physical growth .

Official Title
-----------------
Prevalence and Associated Factors of Functional Gastrointestinal Disorders Among Children Attending Assuit University Children Hospital

Conditions
-----------------
Functional Gastrointestinal Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age group 1 to 18 years old Exclusion Criteria: Age group bwlow 1 year and above 18 years Having other git problem as : GIT bleeding H pylori infection Cow's milk protein allergy or IBD or any other symptoms suggestive to organic GI disease

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 18 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of functional gastrointestinal disorders among children attending gastrointerology clinic of Assuit University Children Hospital | A number will calculated | 50 weeks | 
| The associated factors | Demographic and social | 50 weeks |
Substitution of the PCL in TKA With UC or PS Design

Study Overview
=================
Brief Summary
-----------------
RCT comparing UC and PS TKA

Detailed Description
-----------------
RCT comparing TKA with either ultraconguent insert or posterior stabilized design for substitution of the posterior cruciate ligament

Official Title
-----------------
Substitution of the Posterior Cruciate Ligament in Total Knee Arthroplasty With Ultracongruent Insert or Posterior Stabilzed Design

Conditions
-----------------
Patient Reported Outcome, Knee Osteoarthritis, Knee Arthroplasty

Intervention / Treatment
-----------------
* Other: TKA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: scheduled for TKA Exclusion Criteria: higher constraint needed

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: UC<br>Total Knee Arthroplasty with an ultracongruent insert | Other: TKA<br>* Total Knee Arthroplasty<br>|
| Active Comparator: PS<br>Total Knee Arthroplasty with posterior stabilized design | Other: TKA<br>* Total Knee Arthroplasty<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ROM | Range of motion | 10 years | 
| Patient reported outcome | Oxford Knee Score min 0 points (worst), max 48 points (best) | 10 years |
ICG- Liver Test Versus New Biomarkers as Prognostic Markers in Critically Ill Patients

Study Overview
=================
Brief Summary
-----------------
Comparison of ICG liver testing with copeptin and SAPS II score as prognostic markers in critically ill patients.

Detailed Description
-----------------
Comparison of different marker for length of stay in the ICU in critically ill patients.

Official Title
-----------------
ICG- Liver Test Versus New Biomarkers as Prognostic Markers in Critically Ill

Conditions
-----------------
Critically Ill

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients admitted to the ICU Exclusion Criteria: Not able to understand German
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Critically ill patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prolonged length of stay in the ICU (pLOS) more than 3 days | see above | 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prognostic value
Percutaneous Coronary Angioplasty Compared With Exercise Training in Symptomatic Coronary Artery Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare coronary angioplasty with stent implantation with an exercise rehabilitation program in patients with stable coronary artery disease (CAD).

Conditions
-----------------
CAD, Stable Angina Pectoris

Intervention / Treatment
-----------------
* Device: PTCA and Stent Implantation
* Behavioral: Exercise Training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Angiographically documented CAD, with at least one coronary artery stenosis of more than 50% in a native segment never subjected to intervention, which is recommended for treatment with percutaneous transluminal coronary angioplasty (PTCA). Stable coronary artery disease Eligible patients could be asymptomatic or have class I to III angina (Canadian Cardiovascular Society [CCS]) with documented myocardial ischemia Angina pectoris threshold > 50 Watt (cycle ergometry) Permanent residence should be within 25 km of training facility. Exclusion Criteria: < 18 or > 70 years of age Patient currently participating in an exercise training program Unstable angina pectoris or myocardial infarction during the last 2 weeks Symptoms of CCS class IV Exercise limitations due to clinical conditions not related to CAD Left ventricular ejection fraction (LVEF) of < 40% Ventricular arrhythmia (Lown Ivb) Hemodynamically significant valvular heart disease Previous cardiac surgery PTCA performed during the last 12 months Any major non-cardiac condition that would adversely affect survival during the duration of the study Reduced compliance

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: PTCA and Stent Implantation|nan|
|Behavioral: Exercise Training|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Leflunomide in Systemic Lupus Erythematosus

Study Overview
=================
Brief Summary
-----------------
A pilot study to evaluate the efficacy and safety of leflunomide in SLE patients with active disease who are refractory to cyclophosphamide

Official Title
-----------------
A Randomized, Double-Blind, Placebo Controlled Clinical Trial of Leflunomide in Systemic Lupus Erythematosus (SLE)

Conditions
-----------------
Systemic Lupus Eythematosus (SLE)

Intervention / Treatment
-----------------
* Drug: Leflunomide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fulfill the revised ACR criteria for SLE with either evidence of active disease according to SLE Disease Activity Index (SLEDAI) Exclusion Criteria: Patients who are pregnant or nursing women, or those with life threatening disease The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Leflunomide|A loading dose of LEF 100mg daily for 3 days, followed by LEF 20mg daily for the remainder of the study or matching placebo|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients who are able to achieve complete remission, defined as a SLEDAI of 0 |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients who are able to achieve partial remission, as defined by a SLEDAI of 1-3 |  | 52 weeks |
The Second COVID-19 Wave: Collateral Impact on Patients of Liver Disease

Study Overview
=================
Brief Summary
-----------------
Hospital record of the patients of liver disease admitted from April-May 2021 and April-May 2019 will be reviewed. Patients will be analyzed and compared for the demographic characteristics, severity of liver disease at time of admission and outcome in form of survival or mortality, liver transplantation rates in the two time periods and the subsequent 30 d and 90 day readmission rate. Monitoring and assessment: Hospital records of all patients of liver disease needing admission during the April-May 2019 and 2021, but without active COVID-19 infection, will be reviewed. Patients will be analyzed and compared for the demographic characteristics, severity of liver disease at time of admission and outcome in form of survival or mortality, liver transplantation rates in the two time periods and 30 d and 90 d readmission rate.

Official Title
-----------------
The Second COVID-19 Wave: Collateral Impact on Patients of Liver Disease-A Record Based Cross-Sectional Study.

Conditions
-----------------
Liver Diseases

Intervention / Treatment
-----------------
* Other: This is an observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of liver disease requiring hospital admission Exclusion Criteria: Active COVID-19 infection at time of admission or acquiring during hospital stay.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| liver disease without COVID-19 infection-April-May 2019<br> | Other: This is an observational study<br>* This is an observational study<br>|
| liver disease without COVID-19 infection -April- May 2021<br> | Other: This is an observational study<br>* This is an observational study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of in-hospital mortality rate of patients of liver disease admitted in April-May 2021 and April-May 2019. |  | Until discharge or death | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of 30 days readmission rate of patients of liver disease. |  | Day 30 | 
| Comparison of 31 to 90 days readmission rate of patients of liver disease. |  | Day 31-90 | 
| Comparison of liver transplantation rates in the two time periods i.e., April-May 2021 and April-May 2019. |  | 3 months |
Sex Hormone Binding Globulin, Testosterone and Glycemic Control in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Sex hormone-binding globulin(SHBG) is a surrogate marker of insulin resistance. This study aims at the characteristic and clinical significance of SHBG and testosterone in patients with type 2 diabetes(T2D).

Detailed Description
-----------------
The investigators recorded clinical factors, biochemical criterion such as serum levels of glucose and lipids, HbA1c, SHBG, testosterone, insulin, EPO, C-peptide, glucagon, microalbuminuria, glycemic variation via CGM, carotid plaque, ECG and ultrasonic cardiogram in patients with T2D who visited in the Department of Endocrinology at the Nanjing First Hospital from January 2015 to Aprol 2018. The relationship between levels of SHBG, testosterone and glycemic variation/diabetic complications are analysed.

Official Title
-----------------
The Relationship Between Sex Hormone Binding Globulin, Testosterone and Glycemic Control in Patients With Type 2 Diabetes

Conditions
-----------------
Type2 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ● Patients with T2D and the diagnostic criteria of T2D is according to the World Health Organization in 1999. Exclusion Criteria: Patients use systemic steroidal anti-inflammatory drugs. Patients with an acute infection. Patients with acute complication of diabetes.
Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
| sex hormone-binding globulin | the blood sex hormone-binding globulin level of patients | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Testosterone | blood testosterone level of patients | Day 1 | 
| EPO | blood erythropoietin level of patients | Day 1 | 
| HbA1c | the glycosylated hemoglobin level of patients | Day 1 | 
| MBG | 24h mean blood glucose tested by CGM | Day 1-4 | 
| MAGE | the 24h mean amplitude of glycemic excursion | Day 1-4 | 
| SD | the standard deviation of mean glucose | Day 1-4 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sex hormone-binding globulin
Safety and Efficacy in Pediatric MS Patients Prescribed Tysabri

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to evaluate the safety of natalizumab use in the pediatric multiple sclerosis (MS) population.

Detailed Description
-----------------
All available retrospective and prospective data from pediatric MS participants who have received at least 1 dose of natalizumab before turning 18 years old and before 31Mar2015 will be used in this study. Prospective data are defined as data to be collected in the future, i.e., from new participants not included in the first data transfer or additional data from existing participants that were not included in the first data transfer. Existing biospecimen samples will be evaluated but not collected as part of this study.

Official Title
-----------------
Meta-Analysis of the Safety and Efficacy of Natalizumab in Pediatric Patients With Multiple Sclerosis

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: natalizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: All available retrospective and prospective data from pediatric MS patients who have received at least 1 dose of natalizumab before turning 18 years old and before 31 March 2015. In addition, patients must be registered in TOUCH (US patients only), enrolled in a Biogen sponsored postmarketing observational study (e.g., TOP (NCT00493298) or TYGRIS (NCT00477113,NCT00483847)), or in a country-specific TYSABRI registry. Adequate data received by Biogen by 30 September 2015 will be used for this meta-analysis including data collected after a patient may have turned 18 years old. Key Exclusion Criteria: Data received by Biogen after 30 September 2015 will not be included in the statistical analyses NOTE: Other protocol-defined inclusion/exclusion Criteria May Apply

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- |
| natalizumab<br>Natalizumab will not be provided as a part of this study. Participants will receive natalizumab per the local label specifications. | Drug: natalizumab<br>* Administered as specified in the treatment arm.<br>* Other names: Tysabri;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of all serious adverse events (SAEs) |  | Up to 19 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatric
Evaluation of the French Translation of Gothenburg Trismus Questionnaire (GTQ)

Study Overview
=================
Brief Summary
-----------------
A monocentric Study to evaluate the french translation of Gothenburg Trismus Questionnaire (GTQ).

Detailed Description
-----------------
Trismus is defined as a limitation in the mouth/jaw-opening ability due to a reduced mandible mobility. Trismus can occur from benign jaw related conditions, often referred to as temporomandibular disorders (TMD). It can also result from local or metastatic tumor growth of head and neck (H&N) tumors, and more importantly, as a debilitating side-effect to H&N oncology treatment, especially radiotherapy The Gothenburg Trismus Questionnaire (GTQ) is a Patient Reported Outcome, validated in English, portuguese and sweden language. The aim of this study is to develop a new tool in french language and to evaluate the specific impact of trismus on quality of life .

Official Title
-----------------
Evaluation of the French Translation of Gothenburg Trismus Questionnaire (GTQ)

Conditions
-----------------
Trismus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient treated for trismus Age ≥ 18 years old Read, write and understand the French language Exclusion Criteria: Patient under guardianship, deprived of liberty, safeguard of justice Refusal to participate in research

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 |
| --- | --- | --- |
| Gothenburg Trismus Questionnaire (GTQ) | patient Reported Outcome measure: score 0-4 (0 means a better outcome, 4 means a worse outcome.) | once at inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patient reported outcomes, trismus, u Gothenburg Trismus Questionnaire