linjc16/ctgov huggingface dataset:
Evaluation of Long-Term Immunogenicity in Subjects Boosted With a TBE Vaccine for Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of this study it is to evalutate the persistence of antibodies after a booster immunisation with a TBE vaccine for adults

Official Title
-----------------
A Phase IV, Randomized, Open-Label, Multi-Center Study in Adults: Evaluation of Long-Term Immunogenicity in Subjects Boosted With a New TBE Vaccine for Adults (Free of Protein-Derived Stabilizer) in Study V48P2E1, 5 Years After First Booster Immunization and Evaluation of Booster Kinetics in Subjects Boosted With a New TBE Vaccine for Adults (Free of Protein-Derived Stabilizer), 5 Years After First Booster Immunization

Conditions
-----------------
Encephalitis, Tick-Borne

Intervention / Treatment
-----------------
* Biological: Tick-Borne Encephalitis vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers of both sexes aged >18 who participated in another study on TBE vaccination Exclusion Criteria: Subjects with any condition, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.

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
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Tick-Borne Encephalitis vaccine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term antibody kinetics as measured both by ELISA and neutralisation test (NT) five years after first booster immunization. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Booster response in a subset of subjects as measured by NT, ELISA and cellular immunity on Days 3, 5, 7 and 21 after 2nd booster immunization. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TBE, vaccine, adults
Airway Stent Modified With 3D Printing for Gastro-respiratory Fistula Involving Carina and Distal Bronchi

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators used the covered metallic segmented airway stent modified with 3D printing to treat gastro-respiratory fistula involving carina and distal bronchi and aimed to determine the feasibility, efficacy and safety of this technique.

Official Title
-----------------
Covered Metallic Segmented Airway Stent Modified With 3D Printing for Gastro-respiratory Fistula Involving Carina and Distal Bronchi

Conditions
-----------------
Airway Disease, Fistula Bronchial, Fistula, Gastric

Intervention / Treatment
-----------------
* Procedure: Airway stent implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with gastro-respiratory fistula involving carina and bronchi distal to carina based on the diagnosis by bronchoscopy , gastroscopy and CT. The patients who could not tolerate surgery and did not have clinical improvement after conservative treatment. Exclusion Criteria: Severe infection coagulation disorders
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: Segmented Airway Stent for Gastro-Respiratory fistula<br>Segmented covered metallic airway stent modified with 3D printing was used for gastro-respiratory fistula. | Procedure: Airway stent implantation<br>* The segmented airway stent modified with 3D printing were implanted to treat gastro-respiratory fistula involving carina and distal bronchi. The stents were removed because of stent-related complications or tracheobronchial healing.<br>* Other names: Stent removal;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relief of symptoms | Main symptoms as follows: cough, dysphagia, dyspnea, and expectoration. | 1 month | 
| Heal of fistula | The heal of fistula confirmed by gastroscopy, bronchoscopy and CT | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events that are related to stent implantation | Adverse events as follows: migration of the stent, severe chest pain, hemoptysis, granuloma formation, pneumonia and accumulation of secretion | 6 months | 
| Stent patency time | Stent patency time is defined as the time from the stent implantation to stent restenosis or death due to any cause, or censored at date last known alive | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
3D printed, airway stent, carina, distal bronchi
Analgesic Effect of Erector Spinae Plane Block for Renal Colic Pain

Study Overview
=================
Brief Summary
-----------------
Plane blocks have become very popular in recent years with the introduction of ultrasonography into the regional anesthesia and algology practice. Erector spinae plane (ESP) block involves the injection of local anesthetics between erector spinae muscles and transverse process of vertebrae and can block the dorsal and ventral rami of thoracolumbar spinal nerves. The aim of this study was to evaluate the analgesic efficacy of the erector spine plane block for reno-ureteral colic.

Official Title
-----------------
Erector Spinae Plane Block Versus Intravenous Dexketoprofen-trometamol for Treatment of Reno-ureteral Colic: a Randomized Prospective Study

Conditions
-----------------
Renal Colic

Intervention / Treatment
-----------------
* Drug: 30 ml %0.25 bupivacaine
* Drug: Dexketoprofen-trometamol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologist's physiologic state I-II patients Exclusion Criteria: chronic pain bleeding disorders renal or hepatic insufficiency patients on chronic non-steroidal anti-inflammatory medications

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: ultrasound guided erector spinae plane block<br>30 ml %0.25 ultrasound-guided erector spinae plane block at the level of T8 | Drug: 30 ml %0.25 bupivacaine<br>* Ultrasound-guided erector spinae plane block<br>|
| Active Comparator: Dexketoprofen-trometamol<br>intravenous 50 mg dexketoprofen-trometamol | Drug: Dexketoprofen-trometamol<br>* 50 mg Dexketoprofen-trometamol intravenous<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of analgesic consumption | Fentanyl | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Rating Scale | A NRS involves asking the patient to rate his or her pain from 0 to 10 (11 point scale) with the understanding that 0 is equal to no pain and 10 is equal to worst possible pain. NRS score will be recorded after intervention at 5.,10.,15.,30.,45. and 60. minute | 1 hour |
An Observational Research Of Crizotinib's Hepatic Toxicity In Non-small Cell Lung Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Crizotinib, an inhibitor of anaplastic lymphoma kinase (ALK), was approved by Food and Drug Administration (FDA) for the treatment of patients with ALK-positive non-small cell lung cancer (NSCLC) and its administration has achieved considerable success. However, adverse effects inevitably occurred and the most common one was hepatic toxicity, appearing as elevating alanine aminotransferase(ALT) and aspartate aminotransferase(AST). Therefore, the investigators try to figure out the mechanism of crizotinib-inducing hepatic toxicity, and explore whether there is any biological marker to diagnose this side effect in an early stage, which may realize individualized therapy with more efficacy and less side effects.

Official Title
-----------------
An Observational Research on Relationship Between c-Met Gene Polymorphism, Promoter Methylation Level, Related Drug Metabolism Enzymes and Crizotinib's Hepatic Toxicity in Non-small Cell Lung Cancer Patients

Conditions
-----------------
Non-Small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who were histologically and cytologically confirmed NSCLC at stage III or IV harbored ALK fusion gene and took crizotinib age:18 75years Eastern cooperative oncology group performance status(ECOG PS): 0 2 points the expected lifetime is more than 12 weeks after being recruited Exclusion Criteria: patients who also suffered from other malignant tumor uncontrolled systemic diseases,central nervous system (CNS) metastasis clinically active interstitial lung diseases severe liver dysfunction caused by hepatic cirrhosis or hepatitis （Child-Pugh class C, total index score 10-15 points） taking drugs that interact with crizotinib

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with adverse events |  | change from the date of taking crizotinib at 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival |  | from the date of taking crizotinib to the date of objective tumor progression or date of death from any cause,whichever came first,assessed up to 48 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
non-small cell lung cancer, crizotinib, hepatic toxicity
Aspirin Responsiveness in Women at Risk for Cardiac Events

Study Overview
=================
Brief Summary
-----------------
The objective of this pilot study is to evaluate the prevalence of biological aspirin resistance in women at risk for CHD taking low dose (81 mg) aspirin. Aspirin responsiveness will be measured with the VerifyNow device (Accumetrics; San Diego, CA). Those women identified as biologically resistant will be switched to aspirin 325 mg for 14 days and then re-tested for aspirin responsiveness.

Official Title
-----------------
Aspirin Responsiveness in Women at Risk for Cardiac Events: A Pilot Study.

Conditions
-----------------
Heart Disease

Intervention / Treatment
-----------------
* Drug: Aspirin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women at least 19 years old Taking 81 mg aspirin daily, non-enteric coated, for at least one month for the primary prevention of cardiovascular disease. Able and willing to provide informed consent Exclusion Criteria: Pregnancy or breastfeeding Known CHD Currently taking clopidogrel or ticlopidine Use of heparin, warfarin, or glycoprotein IIb/IIIa inhibitors within previous 96 hours Allergy or hypersensitivity to salicylates Use of other OTC or prescription analgesics or anti-inflammatory medication in the past two weeks Currently participating in another investigational drug or device study

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

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

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

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 |
| --- | --- |
| Active Comparator: Aspirin 81mg<br>Resistant | Drug: Aspirin<br>* Aspirin 81mg and Aspirin 325mg, non-enteric coated, take one tablet by mouth daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Women Aspirin Resistant | Aspirin responsive unit (ARU) > 550 was considered to be aspirin resistant and correlates to less than 50% inhibition of platelet aggregation. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Aspirin Resistant Who Became Responders After Increase to Aspirin 325 mg | Aspirin resistance was defined as ARU > 550 | 2 weeks |
A Randomized, Control Trial for Preinduction Cervical Ripening

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to compare the vaginal delivery rates in women undergoing induction of labor with an unripe cervix between oxytocin induction alone and preinduction cervical ripening with prostaglandin El (misoprostol). Secondary goals are to measure and compare the time intervals to delivery between the two methods.

Official Title
-----------------
A Randomized, Control Trial for Preinduction Cervical Ripening

Conditions
-----------------
Labor, Induced

Intervention / Treatment
-----------------
* Drug: Misoprostol
* Drug: oxytocin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women that are hospitalized for induction of labor that have a Bishop's score <5 singleton gestation cephalic presentation 24 weeks gestational age Exclusion Criteria: Prior uterine surgery malpresentation placenta previa or abruption clinically suspected or diagnosed intra amniotic infection genital HSV infection multiple gestation premature rupture of the membranes active labor maternal/fetal conditions that may preclude labor induction in the opinion of the investigators
Sexes Eligible for Study
-----------------
Female

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Misoprostol|nan|
|Drug: oxytocin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal Delivery rates |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time interval to delivery |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
labor, induction, misoprostol, oxytocin
Safety Evaluation of Gene Therapy in Leber Hereditary Optic Neuropathy (LHON) Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and tolerability profile of ascending doses of GS010 in Leber Hereditary Optic Neuropathy (LHON) patients.

Official Title
-----------------
An Open Label Dose Escalation Clinical Trial to Evaluate the Safety and the Tolerability of GS010 (rAAV2/2-ND4) in Patients With Leber Hereditary Optic Neuropathy Due to Mutations in the Mitochondrial NADH Dehydrogenase 4 Gene

Conditions
-----------------
Leber Hereditary Optic Neuropathy

Intervention / Treatment
-----------------
* Genetic: GS010


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented diagnosis of LHON based on a genetic test confirming the presence of the G11778A mutation in the mitochondrial ND4 Age 18 years old or older at the time of study entry (informed consent signature) Visual acuity ≤ 1/10 of the less functional eye Exclusion Criteria: Any known allergy or hypersensibility to one of the product used during the trial Contraindication to IVT surgery (anaemia Hb <8g/dl, severe cardiovascular disease, severe coagulopathy…) Disorder of the ocular humors and of the internal retina involving visual disability Glaucoma Presence of other pathology whose symptoms or associated treatments might affect the retina or the optic nerve Vascular retinal occlusion Narrow angle contra-indicating pupillary dilation Other cause of optic neuropathy (inflammatory conditions or exposure to toxins...) Patients presenting known mutation of other genes implicated in pathological retinal conditions

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GS010<br> | Genetic: GS010<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of local and general adverse events and Serious Adverse Events |  | Up to 48 weeks |
The Evaluation of Bepreve on the Measurement of Wheal and Flare Response From Histamine Skin Prick Testing

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of BEPREVE compared to a REFRESH Tears Lubricant eye drop on the measurement of the wheal and flare from histamine skin prick testing. This is an open label, two-week, post-marketing study conducted on histamine responsive patients.

Official Title
-----------------
The Evaluation of the Effect of Bepreve, a Topical Ocular Antihistamine, on the Measurement of Wheal and Flare Response From Histamine Skin Prick Testing

Conditions
-----------------
Histamine Responsive Allergy Patients

Intervention / Treatment
-----------------
* Drug: Bepreve
* Drug: Refresh Tears


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and female subjects, 18 to 65 years of age Patients must demonstrate a positive reaction to a Histamine skin-prick test. Manifested by a histamine-induced wheal of >3mm in diameter over the normal saline control after 15 minutes of elapsed time Exclusion Criteria: Significant signs and symptoms of currently active allergic disease (SAR, perennial allergic rhinitis, episodic allergic rhinitis) Upper respiratory tract infection, sinusitis, asthma or flu-like symptoms within 2 weeks prior to visit 1 Subjects who have dermatographism or other skin conditions which might interfere with the interpretation of the skin test results Subjects who are receiving escalating doses of immunotherapy, oral immunotherapy or short course (rush) immunotherapy Known hypersensitivity to the investigational product or to drugs with similar chemical properties Pregnancy and/or breast feeding Use of antihistamines, NSAIDS, steroids, or other drugs which may affect the skin-response Use of any medications or agents that are not specified above that may confound the interpretation of the results

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

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

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bepreve<br>topical ocular treatment as indicated | Drug: Bepreve<br>* Bepreve (bepotastine besilate ophthalmic solution 1.5%) one drop in each eye twice daily<br>* Other names: bepotastine besilate;Drug: Refresh Tears<br>* Refresh Tears one drop to each eye twice daily for 7 days after the conclusion of Bepreve treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measurement of Wheal and Flare response from histamine skin-prick testing |  | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
allergic conjunctivitis, histamine skin testing