linjc16/ctgov huggingface dataset:
Intravitreal Bevasizumab Versus Intravitreal Triamcinolone in Central Retinal Vein Occlusion (CRVO)

Study Overview
=================
Brief Summary
-----------------
This randomized clinical trial is conducted to evaluate the effect of three intravitreal injections of bevasizumab versus two intravitreal injections of triamcinolone in acute central retinal vein occlusion. The outcomes are visual acuity and central macular thickness. The follow-up time is 6 months.

Official Title
-----------------
Three Injections of Intravitreal Bevasizumab Versus Two Injections of Intravitreal Triamcinolone in the Management of Branch Retinal Vein Occlusion

Conditions
-----------------
Central Retinal Vein Occlusion

Intervention / Treatment
-----------------
* Drug: Bevasizumab
* Drug: Triamcinolone Acetonide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recent onset (less than 3 months) central retinal vein occlusion Exclusion Criteria: Any previous intervention
Sexes Eligible for Study
-----------------
All

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intravitreal triamcinolone<br> | Drug: Triamcinolone Acetonide<br>* Intravitreal, 2 mg, 2 times, two months apart.<br>|
| Active Comparator: Intravitreal bevasizumab<br> | Drug: Bevasizumab<br>* Intravitreal, 1.25 mg, 3 times, one month apart.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| central macular thickness |  | 6 months |
Neural Alteration Response to Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Depressed Patients

Study Overview
=================
Brief Summary
-----------------
Electrical vagus nerve stimulation (VNS) was approved by FDA for treatment of chronic recurrent depression in 2005. Recently, non-invasive, transcutaneous auricular vagus nerve stimulation （taVNS） has already been used for depression treatment. However, the neural mechanism remains unclear, and the relationship between stimulation parameters and neural response were also unknown. The present study aims to investigate the specific brain activation in depression patients after taVNS，compared with healthy controls.

Official Title
-----------------
Xidian University,China

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Device: Transcutaneous electrical vagus nerve stimulation
* Device: Sham vagus nerve stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meets ICD-10 diagnosis standard; without taking anti-depressive medication or other psychiatric medications 2 weeks before the experiment; Patient has exhibited symptoms for at least 2 months, but no longer than 2 years. Exclusion Criteria: With current addiction to drugs; With other severe organic diseases, such as severe heart disease, kidney failure etc; disagree with the consent form. Cannot receive MRI scan.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active-raVNS<br>Transcutaneous electrical vagus nerve stimulation at ear. | Device: Transcutaneous electrical vagus nerve stimulation<br>* All subjects receive electrical VNS stimulation at cymba conchae.<br>|
| Sham Comparator: Sham-raVNS<br>Sham vagus nerve stimulation at ear. | Device: Sham vagus nerve stimulation<br>* All subjects receive electrical stimulation at earlobe.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| actual neural activation in brain | By using fMRI technology, the BOLD signal of brain is analyzed. | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate variability | Frequency domain methods is used to analyze the bands of frequency and then count the number of NN intervals that match each band. The bands are typically high frequency (HF) from 0.15 to 0.4 Hz, low frequency (LF) from 0.04 to 0.15 Hz, and the very low frequency (VLF) from 0.0033 to 0.04 Hz. | 2 hours |
The Role of Psychosocial and Other Quality of Life Parameters in Evaluating Functional Changes Prior to and Following Laser In-situ Keratomileusis (LASIK)Changes Laser In-situ Keratomileusis (LASIK)

Study Overview
=================
Brief Summary
-----------------
To evaluate the changes in quality of life parameters after LASIK surgery.

Detailed Description
-----------------
Our purpose is to evaluate the changes in quality of life parameters after LASIK surgery. We intend to create a questionnaire to delineate the changes that occur in LASIK patients at the pre-operative visit and at the 1-month and 3-month post-operative visits. Additional questionnaires will be administered to demonstrate the validity of the new questionnaire. The approximate time the patient will be required to spend in clinic will be approximately 45 minutes at each of the three visits.

Official Title
-----------------
The Role of Psychosocial and Other Quality of Life Parameters in Evaluating Functional Changes Prior to and Following Laser In-situ Keratomileusis (LASIK)

Conditions
-----------------
Keratomileusis, Laser In Situ

Intervention / Treatment
-----------------
* Behavioral: Role of psychosocial and quality of life parameters prior to and following LASIK.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All refractive surgery patients with otherwise normal eyes undergoing routine LASIK as a primary refractive procedure for myopia, hyperopia or astigmatism. - Exclusion Criteria: Patients who elect to perform alternative refractive surgery such as PRK, RK, or Intacts™. -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Role of psychosocial and quality of life parameters prior to and following LASIK.|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
-----------------
Patients who have undergone routine LASIK as a primary refractive procedure for myopia, hyperopia, or astigmatism.
Evaluation of Effectiveness and Safety of XIENCE Sierra in Routine Clinical Practice

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate effectiveness and safety of Xience Sierra stent in the real world daily practice as compared with other drug-eluting stents.

Official Title
-----------------
Evaluation of Effectiveness and Safety of XIENCE Sierra in Routine Clinical Practice; A MULTICENTER, PROSPECTIVE OBSERVATIONAL STUDY

Conditions
-----------------
Coronary Artery Disease, Coronary Disease

Intervention / Treatment
-----------------
* Device: Xience Sierra stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 19 and more Patient with Xience Sierra Everolimus eluting coronary stent Exclusion Criteria: Intervention with Xience Sierra Everolimus eluting coronary stent and other drug eluting stent at the same time Life-expectancy less than 1 year Cardiac shock

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Consecutive percutaneous coronary intervention<br> | Device: Xience Sierra stent<br>* Percutaneous coronary intervention with Xience Sierra stent<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite event rate of death, non-fatal myocardial infarction (MI), or Target- Vessel Revascularization (TVR) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause death |  | 5 year | 
| Cardiac death |  | 5 year | 
| Myocardial Infarction |  | 5 year | 
| Composite event rate of death or myocardial infarction (MI) |  | 5 year | 
| Composite event rate of cardiac death or myocardial infarction (MI) |  | 5 year | 
| Target- Vessel Revascularization |  | 5 year | 
| Target- Lesion Revascularization |  | 5 year | 
| Stent thrombosis |  | 5 year | 
| Stroke |  | 5 year | 
| Procedural Success rate | Procedural success rate is defined as < 30 % final stenosis and the absence of in-hospital event including death, myocardial infarction, repeat revascularization. | 5 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Xience Sierra, Drug Eluting Stent, Percutaneous coronary intervention
Pharmacokinetic Study of Clarithromycin in Very Low Birth Weight (VLBW)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the pharmacokinetics of clarithromycin which is used for premature infants with ureaplasma.

Official Title
-----------------
Pharmacokinetic Study of Clarithromycin in Premature Infants With Safety Evaluation

Conditions
-----------------
Very Low Birth Weight Infant, Ureaplasma/Mycoplasma Positive

Intervention / Treatment
-----------------
* Drug: Clarithromycin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: birthweight < 1500gm or GA < 32 weeks transtracheal aspirate/gastric juice ; ureaplasma/mycoplasma(+) Exclusion Criteria: sepsis, hypotension, shock major congenital anomaly

Ages Eligible for Study
-----------------
Maximum Age: 1 Month

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: clarithromycin<br>Population PK | Drug: Clarithromycin<br>* IV clarithromycin infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacokinetics | AUC, Cmax | 72 hours after first infusion |
a Vigibase Pharmacovigilance Study of ENzalutamide Drug-induced neurotoxicitY

Study Overview
=================
Brief Summary
-----------------
Enzalutamide may lead to various adverse reactions. This study investigates reports of different neurological toxicities in the World Health Organization's (WHO) global database of individual safety case reports (VigiBase).

Detailed Description
-----------------
Enzalutamide are responsible of a wide range of side effects.The investigators use VigiBase, the World Health Organization (WHO) database of individual safety case reports, to identify cases of adverse drug reactions following treatment with enzalutamide

Official Title
-----------------
Monitoring the Neurological Toxicity of Enzalumatide Through VigiBase, a Pharmacovigilance Study

Conditions
-----------------
Prostate Cancer, Neuropathy, Epilepsy, Encephalopathy

Intervention / Treatment
-----------------
* Drug: Enzalutamide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2020 Adverse events reported were including any MedDRA terms Patients treated with enzalutamide reported in the WHO database. Exclusion Criteria: Chronology not compatible between the drug and the toxicity

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| Enzalutamide drug-induced toxicity<br>Cases reported in the World Health Organization (WHO) and the French pharmacovigilance database of patients treated by enzalutamide, with a chronology compatible with the drug toxicity | Drug: Enzalutamide<br>* Enzalutamide for the treatment of prostate cancer or other solid tumors<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with neurological adverse events with significant over-reporting enzalutamide | Identification and report of neurological toxiciy of enzalutamdie | Case reported in the World Health Organization (WHO) of individual safety case reports to January 2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drug-induced neurotoxicity
A Study on the Effectiveness of Laparoscopic Fundoplication on Extraesophageal Manifestations of Gastroesophageal Reflux Disease (GERD)

Study Overview
=================
Brief Summary
-----------------
Available data regarding the effectiveness of laparoscopic antireflux surgery on extraesophageal symptoms of gastroesophageal reflux disease (GERD) are scarce and mostly controversial. The aim of the present study was to evaluate the clinical effect of partial and total fundoplication on extraesophageal symptoms in a selected cohort of patients with GERD.

Conditions
-----------------
Extraesophageal Symptoms, Gastroesophageal Reflux Disease (GERD)

Intervention / Treatment
-----------------
* Procedure: Laparoscopic anti-reflux surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: persistent or recurrent symptoms despite continuous medical treatment, at least one typical reflux symptom (heartburn/ regurgitation/dysphagia/epigastric pain) and/or at least one atypical reflux symptom (cough/ asthma/hoarseness/distortion of taste), pathologic esophageal acid exposure as documented by a reflux-related DeMeester score ≥14.7, and symptom correlation ≥50%, and/or reflux episodes >73. Exclusion Criteria: previous esophageal or gastric surgery, poor physical status (American Society of Anesthesiologists (ASA) scores III and IV) and pregnancy.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nissen fundoplication<br> | Procedure: Laparoscopic anti-reflux surgery<br> <br> |
| Active Comparator: Toupet fundoplication<br> | Procedure: Laparoscopic anti-reflux surgery<br> <br> |

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
-----------------
extraesophageal symptoms of gastroesophageal reflux disease
Carriage of Beta Haemolytic Streptococci During Pregnancy

Study Overview
=================
Brief Summary
-----------------
This is a prospective clinical study that aims to investigate asymptomatic carriage of beta haemolytic streptococci (especially group A streptococci, GAS and group B streptococci, GBS) during pregnancy. Association of asymptomatic carriage to possible complications of the mother or the newborn as well as the transmission between spouses will be evaluated. Maternal microbiota during labour will also be studied.

Official Title
-----------------
Carriage of Beta Haemolytic Streptococci During Pregnancy

Conditions
-----------------
Pregnancy Related

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women partner of the pregnant women over/equal 18 years of age willing to participate the study Exclusion Criteria: multiple pregnancy age <18 years

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 |
| --- | --- |
| Pregnant women<br>Microbiological samples are collected from the pregnant women in the mid-pregnancy and during the delivery. Patient records of these women and newborns are investigated for any infections or complications during and after the delivery. | |
| Partners<br>Partners of the pregnant women will be studied to understand the household transmission of studied bacteria and possible risk factors for carriage. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carriage of beta haemolytic streptococci | Throat and vaginal carriage of beta haemolytic streptococci (especially GAS and GBS) during pregnancy. Transmission and longitude of the carriage will be evaluated as well. | up to 30 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy or delivery related infections/complications | Patient records of the pregnant women will be surveyed for any complications/infections until 12 week after delivery. Data will be analysed together with the microbiological findings from the women. | up to12 weeks | 
| Infections/complications of newborn | Patient records are surveyed to search for any infections/complications of the newborn until 12 weeks of age. Data will be analysed together with the findings from their mother. | 12 weeks after birth | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pregnancy, group a streptococci, group b streptococci, carriage, microbiota, Streptococcus pyogenes, Streptococcus agalactiae
Bone Strength After Spinal Cord Injury

Study Overview
=================
Brief Summary
-----------------
Background: After a traumatic spinal cord injury, a severe bone loss in the paralyzed extremities is observed. This leads to a osteoporosis which is connected to a high fracture risk. Aims: To compare the two measurement methods DEXA and pQCT concerning optimal diagnostics and assessment of fracture risk in subjects with spinal cord injury. Subjects: 250 women and 250 men (age≥18, any AIS-classification) with an acute or chronic spinal cord injury will be recruited for this study. For a reference group, 500 able-bodied persons will be measured analogously. Methods: Using DEXA-Osteodensitometry, bone parameters of the lumbar vertebral column, proximal femur, distal radius, distal tibia and knee area will be assessed. Additionally, geometric bone parameters of the tibia will be measured by using pQCT. All measurements will be done unilaterally. For the assessment of potential risk factors for reduced bone stiffness after spinal cord injury a questionnaire will be used.

Official Title
-----------------
Impact of Spinal Cord Injury on Bone Strength in Paralysed Extremities.

Conditions
-----------------
Spinal Cord Injury

Intervention / Treatment
-----------------
* Radiation: DXA
* Radiation: pQCT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Spinal Cord Injury mobilized patients written informed consent Exclusion Criteria: current fracture limited mobility contractures of the lower limbs decubitus ulcer pregnancy

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 |
| --- | --- |
| Spinal Cord Injury<br>Persons with spinal cord injury Osteodensitometry DXA pQCT | Radiation: DXA<br>* Osteodensitometry<br>Radiation: pQCT<br>* Osteodensitometry<br>|
| Reference<br>Reference population (able-bodied) Osteodensitometry DXA pQCT | Radiation: DXA<br>* Osteodensitometry<br>Radiation: pQCT<br>* Osteodensitometry<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone parameters | Measurement of the extremities with DEXA and pQCT | just one timepoint | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fractures | Number of fractures since SCI | just one timepoint (questionnaire) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoporosis, BMD, SCI, DXA, pQCT
Clinical Validation of a New Algorithm for Computerized Dosing of Vitamin K Antagonist Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the new algorithm is safety and effective in proposing the dosage and the timing of oral anticoagulant therapy.

Official Title
-----------------
Clinical Validation of a New Algorithm for Computerized Dosing of Vitamin K Antagonist Therapy

Conditions
-----------------
Anticoagulated Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: to take oral anticoagulant therapy for at least 2 years to be in stable conditions for at last 3 months Exclusion Criteria: patients who need to perform surgery patients who interrupt therapy

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 in oral anticoagulant therapy<br>Patients taking oral anticoagulant therapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time spent in therapeutic range of INR by the patients |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thrombotic and bleeding events |  | 6 months |