linjc16/ctgov huggingface dataset:
Genetics in Non-response to Anti-VEGF Treatment in Exudative AMD

Study Overview
=================
Brief Summary
-----------------
To assess genetic features and intraocular cytokine profiles of non-responders to anti-VEGF treatment of exudative age-related macular degeneration. Also to assess necessity and frequency of pro re nate medical re-treatment.

Official Title
-----------------
Pharmacogenetics in Anti-VEGF Treatment Non-responders Suffering Exudative Age-related Macular Degeneration (AMD): Genetic Correlations and Intraocular Cytokine Concentrations

Conditions
-----------------
Macular Degeneration

Intervention / Treatment
-----------------
* Drug: Ranibizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: active subfoveal CNV related to exudative age-related macular degeneration (all subforms) age > 60 years visual acuity > 20/400 no previous treatment for AMD Exclusion Criteria: any previous AMD therapy other CNV types (myopic, parapapillary) contraindication for ranibizumab treatment prior study participation for AMD pregnancy / premenopausal women

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- |
| Other: ranibizumab as needed<br> | Drug: Ranibizumab<br>* upload (three monthly injections), re-treatment as needed<br>* Other names: Lucentis;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity | Change in visual acuity within the observation period | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between treatment response and genotype |  | 2 years | 
| Changes in OCT central retinal thickness / retinal volume |  | 2 years | 
| Association between treatment application delay and visual outcome |  | 2 years | 
| Association between re-treatment necessity / frequency and intraocular cytokine profiles |  | 2 years |
Uncemented Compared to Cemented Femoral Stems in Total Hip Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate whether an uncemented hip prosthesis is as safe as an cemented hip prosthesis for patients undergoing total hip arthroplasty surgery following a displaced femoral neck fracture.

Detailed Description
-----------------
The study will randomize patients between an uncemented and cemented stem

Official Title
-----------------
Study of Prosthesis Choice in Older Patients With a Dislocated Femoral Neck Fracture of the Hip

Conditions
-----------------
Hip Fractures

Intervention / Treatment
-----------------
* Procedure: Uncemented femoral stem
* Procedure: Cemented femoral stem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute Displaced femoral neck fracture Subject is aged between 65-79 years Independent walker with or without walking aides Subject is able and capable of providing consent to participate in the study Exclusion Criteria: Patients with Rheumatoid Arthritis Patients with an impaired cognitive dysfunction Patients with Pathological fractures Patients with substance abuse Patients with fracture older than 36-hours on arrival at the A&E Patients suffering from cancer Patients determined by principal investigator to be unsuitable for inclusion

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 79 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cemented femoral stem<br>Patient undergoing total hip arthroplasty surgery | Procedure: Cemented femoral stem<br>* All patients will be randomized to operation with either an uncemented femoral stem or a cemented femoral stem<br>* Other names: CPT cemented femoral stem;|
| Active Comparator: Uncemented femoral stem<br>Patients undergoing total hip arthroplasty | Procedure: Uncemented femoral stem<br>* All patients will be randomized to operation with either an uncemented femoral stem or a cemented femoral stem<br>* Other names: BiMetric uncemented femoral stem;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hip related complication rate | All hip-related complications | 2 years | 
| Health-related Quality of Life | Health related quality of life | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of surgery |  | 2 years | 
| Intraoperative bleeding |  | 2 years | 
| Hip function | Measured with Harris hip score | 2 years |
Comparison Between Erythromycin and Neomycin Treatment of Hepatic Encephalopathy

Study Overview
=================
Brief Summary
-----------------
Comparison between the efficacy of two different antibiotics in patients with overt hepatic encephalopathy. The study is randomized, controlled and double-blinded.

Official Title
-----------------
Erythromycin Versus Neomycin Treatment for Overt Hepatic Encephalopathy: a Double-blind, Randomised, Controlled Trial.

Conditions
-----------------
Hepatic Encephalopathy, Hypertension, Portal, Liver Cirrhosis

Intervention / Treatment
-----------------
* Drug: Erythromycin
* Drug: Neomycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hepatic cirrhosis or portal hypertension Hepatic Encephalopathy Exclusion Criteria: Acute liver failure Neuropsychiatric diseases Inflammatory bowel diseases Intestinal obstruction Shock Renal insufficiency Alcoholic hepatitis Alcohol abuse Antibiotic premedication

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: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Erythromycin<br> | Drug: Erythromycin<br>* 250 mg orally q.i.d.<br>|
| Active Comparator: Neomycin<br> | Drug: Neomycin<br>* 1 g orally q.i.d.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery of hepatic encephalopathy | comparison of efficacy between two drugs for the treatment of hepatic encephalopathy | three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of hospitalization caused by hepatic encephalopathy | comparison of efficacy between two drugs for reducing the length of hospitalization during treatment of hepatic encephalopathy | three years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatic Encephalopathy, Hypertension, Portal, Liver Cirrhosis, Bacterial Overgrowth Syndrome
Comparison of the Effects of Phenylephrine and Norepinephrine on Cardiac Function During Carotid Artery Surgery

Study Overview
=================
Brief Summary
-----------------
This will be a prospective, randomized, double-blinded, cross-over clinical trial to compare the effects of phenylephrine or norepinephrine on cardiac function during carotid artery surgery in patients under general anesthesia. The effect of the vasopressor on cardiac function will be measured using electrocardiography, transesophageal echocardiography and cardiac troponin I intraoperatively and postoperatively. We will use a cross-over pattern since both drugs exhibit rapid onset and short duration of action. We hypothesize that there will be less myocardial ischemia associated with the use of norepinephrine when compared with phenylephrine during carotid artery surgery.

Official Title
-----------------
Comparison of the Effects of Phenylephrine and Norepinephrine on Cardiac Function During Carotid Cross-Clamping During Carotid Endarterectomy Under General Anesthesia

Conditions
-----------------
Vasopressor Agents, Endarterectomy, Carotid, Echocardiography, Transesophageal

Intervention / Treatment
-----------------
* Drug: Comparison of Effects of Phenylephrine and Norepinephrine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective carotid endarterectomy under general anesthesia > 18 years old Written informed consent Exclusion Criteria: Contraindication to general anesthesia Contraindication to transesophageal anesthesia esophageal disease esophageal stricture history of esophageal or gastric bleeding esophageal anatomic abnormality past esophageal or gastric surgery severe dysphagia

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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Comparison of Effects of Phenylephrine and Norepinephrine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial ischemia measures by transesophageal echocardiography and ST segment analyses |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial ischemia measures by cardiac troponin I |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vasopressor agents, carotid endarterectomy, cardiac function, transesophageal echocardiography, wall motion abnormalities
Chromosomal Damage in Type 2 Diabetes Patients (MIKRODIAB)

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine whether glycemic control (HbA1c) is linked to chromosomal damage in type 2 Diabetes patients

Official Title
-----------------
Incidence of Chromosomal Damage in Type 2 Diabetes Patients

Conditions
-----------------
Type 2 Diabetes, Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 Diabetes (T2DM) Sex: female Age: > 30years Medication: oral anti-diabetics and/or Insulin therapy Constant nutritional behavior, constant physical activity, constant weight for the last 4 weeks Non-smoking for at least 1 year Exclusion Criteria: Patients with type 1 DM Age: < 30years Pregnant or lactating women Participation in another clinical trial Change of medication in regard to metabolic parameters within the last 4 weeks Significant cardiovascular damage with NYHA > III Liver disease with three-times higher transaminase values Chronic kidney disease with serum creatinine > 2 mg/dl Dialysis HIV positive History of chronic alcohol abuse in the last two years History of cancer, stroke, organ transplantation Male

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Type 2 diabetes, HbA1c>7.5<br> | |
| Type 2 diabetes, HbA1c<7.5<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The quality of HbA1c influences micronuclei formation in binucleated cells | In this cross-sectional study the micronuclei formation in binucleated lymphocytes (Number of micronuclei/1000 binucleated cells) is compared between a low (HbA1c<7.5%) and a high (HbA1c>7.5%) glycemic group | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type 2 diabetes duration of the subjects influences chromosomal damage | The micronuclei formation in binucleated lymphocytes (Number of micronuclei/1000 binucleated cells) is associated with the duration of the Typ 2 diabetes disease. | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 Diabetes, DNA damage, HbA1c, Comet Assay, Glycemic control, Chromosomal damage, Micronuclei
Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices

Study Overview
=================
Brief Summary
-----------------
To monitor post-market performance through evaluation of short and long-term performance via: Efficacy Safety Patient reported outcomes

Detailed Description
-----------------
As this is a post-market registry on market approved devices, there will be no formal hypothesis testing. However, points of evaluation will include: Characterize the efficacy of the AMS market approved female pelvic health products using standard of care outcome measures and validated quality of life questionnaires Characterize the type, severity, and rate of adverse events related to each AMS market approved female pelvic health product Collect concomitant procedural data related to the pelvic floor area

Official Title
-----------------
Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices

Conditions
-----------------
Female Stress Incontinence, Pelvic Organ Prolapse

Intervention / Treatment
-----------------
* Device: Elevate PC
* Device: Mini Arc Pro
* Device: RetroArc


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must meet all of the following criteria to be considered for inclusion in the registry. Have a signed Informed Consent Form Have a signed HIPAA Authorization Form or equivalent Patient Privacy Form if required outside of the US Is a female at least 18 years of age Is scheduled to receive at least one (1) AMS market approved female pelvic health implantable product. Is able and willing to participate in the registry Exclusion Criteria: Patients will be excluded from the registry if any one of the following criteria is met. Patients are contraindicated to receive the target AMS market approved female pelvic health product per the product's IFU

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Elevate PC<br>Subjects implanted with Elevate PC | Device: Elevate PC<br>* List of AMS prolapse products<br>|
| Mini Arc Pro<br>Subjects implanted with Mini Arc Pro | Device: Mini Arc Pro<br>* List of AMS Urinary Incontinence devices<br>|
| RetroArc<br>Subjects implanted with RetroArc | Device: RetroArc<br>* List of AMS Urinary Incontinence devices<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prolapse Efficacy - POP-Q | Prolapse Endpoints: • POP-Q measurement | annually, upto 5 years | 
| Urinary Incontinence Endpoints | Urinary Incontinence Endpoints: Cough stress test 1 hour pad weight test Urodynamics | annually upto 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
POP, vaginal repair, urinary slings, SUI, prolapse, incontinence
Compression Ultrasonography in Non-high Probability of Deep Vein Thrombosis

Study Overview
=================
Brief Summary
-----------------
Compression ultrasound is commonly used in emergency department. Accuracy to rule out deep vein thrombosis is excellent but lower then Ddimer assessment which is actually gold standard. With progress in formation of emergency physicians (EP), quality of material used, the investigators hypothesize that compression ultrasound can rule out deep vein thrombosis in case of non high probability, as standard care and DDimer assay.

Official Title
-----------------
Evaluation of the Predictive Value of Compression Venous Ultrasound by the Emergency Physician for Excluding the Diagnosis of Proximal Deep Vein Thrombosis (DVT) in Patients With Non-high Clinical Pretest Probability

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

Intervention / Treatment
-----------------
* Other: compression ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patient Patient presenting to the emergency department with clinical suspicion of DVT (i.e. pain and/or lower extremity edema). Patient with a non-high probability according to the modified Wells score, i.e. a score of 0 or 1 Subject with a social health insurance plan Subject able to understand the objectives and risks of the research and to give a signed and dated informed consent Exclusion Criteria: Patient with suspected pulmonary embolism Patient with a high probability of DVT Impossible to perform a whole leg doppler ultrasound within 5 days Pregnant or breast-feeding woman, on patient's declaration Subject under court protection Subject under guardianship or curatorship

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 |
| --- | --- |
| Experimental: Patient with clinical suspicion of deep vein thrombosis<br> | Other: compression ultrasound<br>* performing a compression ultrasound<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negative predictive value of compression ultrasound for diagnosis of deep vein thrombosis |  | The measurement is assessed during ED stay or in 5 days if DD is positive with no DVT in compression ultrasound |
Pharmacokinetic Behavior of Phenolic Acids Derived From Black Tea

Study Overview
=================
Brief Summary
-----------------
This study is set up to determine pharmacokinetics of phenolic acids after a single oral dose to healthy males.

Official Title
-----------------
Pharmacokinetic Behavior of Phenolic Acids Derived From Black Tea

Conditions
-----------------
Cardiovascular Diseases

Intervention / Treatment
-----------------
* Dietary Supplement: hot water
* Dietary Supplement: Black tea and phenolic acids


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy males not smoking Exclusion Criteria: use of NSAIDS and/or antibiotics no blood donation 1 months prior to screening

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Black tea<br>black tea | Dietary Supplement: Black tea and phenolic acids<br>* Black tea extract and capsule with phenolic acids<br>|
| Placebo Comparator: placebo<br> | Dietary Supplement: hot water<br>* Hot water and placebo capsule<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentrations of selected phenolic acids |  | up to 30 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma concentration of selected flavonoid metabolites |  | up to 30 hrs | 
| Identification of unknown phenolic acids (metabolites of black tea) in plasma | It is still largely unknown which metabolites are formed in-vivo after black tea ingestions and circulating in human plasma. Untargeted profiling using LC-MS of plasma samples will be used to identify yet unknown polyphenols / phenolics and their conjugates in plasma and thus extent the hit-list of known metabolites in circulation after black tea consumption | up to 30 hrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Black tea, phenolic acids