linjc16/ctgov huggingface dataset:
A Study to Evaluate the Safety and Tolerability of Zidovudine (ZDV) in Premature Infants Born to HIV-Positive Women.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the safety and tolerability of ZDV when given to premature infants born to HIV-positive women to prevent HIV infection. ZDV has been used successfully to prevent the transmission of HIV from mother to child during pregnancy and birth. However, ZDV has been given to very few premature babies, and the best dose to use has not yet been determined.

Detailed Description
-----------------
In the preliminary group of premature infants, those receiving q 6h dosing had an average trough concentration of 7.3 uM (18%). However, the premature infants in the preliminary pharmacokinetic study did not have long term follow-up to assess toxicity. Due to the potential for altered ZDV pharmacokinetics and increased toxicity in this population, an evaluation of ZDV pharmacokinetics in premature infants is proposed. Premature infants less than or equal to 34 weeks gestational age at birth and begun on ZDV by their clinical caregivers will be entered into the protocol within the first 5 days of life. Upon entry, ZDV will be administered every 12 hours intravenously or orally. The study will require 9 serum samples for ZDV assay collected over 30 days, some additional clinical laboratory tests collected over 12 weeks, collection of 3 spot urine samples, and collection of routine clinical data.

Official Title
-----------------
The Safety, Tolerance, and Pharmacokinetics of Zidovudine in Premature Infants Exposed to HIV.

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Zidovudine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Your baby may be eligible for this study if he/she: Requires ZDV (as decided by your doctor) because you are HIV-positive. Is 1-5 days old and was born prematurely. Exclusion Criteria Your baby will not be eligible for this study if he/she: Is not expected to live 6 weeks because of severe illness. Is having problems with blood pressure or is not urinating enough.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 5 Days

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

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

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

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Zidovudine|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
-----------------
Zidovudine, Anti-HIV Agents
A Pilot Clinical Investigation of the Efficacy and Safety of Uracyst® Versus Placebo in Patients With Interstitial Cystitis/Painful Bladder Syndrome.

Study Overview
=================
Brief Summary
-----------------
This is a pilot clinical investigation. Patients who meet the eligibility criteria and provide signed informed consent will be randomized to receive either an active product (Uracyst®) or placebo intravesically via a bladder catheter weekly for 6 weeks, followed by 6 weeks of follow-up period.

Official Title
-----------------
A Multi-Center, Randomized, Double-Blind, Parallel Group Evaluation of the Efficacy and Safety of Uracyst® (Intravesical Sodium Chondroitin Sulfate) Versus Vehicle Placebo in Patients With Interstitial Cystitis/Painful Bladder Syndrome.

Conditions
-----------------
Interstitial Cystitis

Intervention / Treatment
-----------------
* Device: placebo
* Device: Uracyst


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Are female of male patient 18 years or older Have been previously diagnosed with IC/PBS. Are willing to provide informed consent Available for the duration of the study including treatment and follow-up (12 weeks) Exclusion Criteria: Pregnant or lactating female. Are currently or have previously received investigational drugs within thirty (30) days of screening. Previous therapy for IC/PBS Have any medical condition/disease that could interfere with patient compliance or interfere with interpretation of the study results. Are unable or unwilling to comply with protocol requirements Are unable to read, understand, and provide written informed consent.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Uracyst<br>Sodium chondroitin sulfate | Device: Uracyst<br>* 20 ml sterile solution for weekly intravesical instillation<br>* Other names: sodium chondroitin sulfate;|
| Placebo Comparator: Placebo<br>placebo | Device: placebo<br>* bladder instillation<br>* Other names: device vehicle;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to 6 weeks in Global Response Assessment instrument (GRA)score. The GRA evaluates symptoms of intersticial cystitis |  | Baseline to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event assessments |  | Throughout the study, first instillation to Week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IC/PBS, Interstitial Cystitis/Painful Bladder Syndrome
Pathological Results of Aggressive Hepatocellular Carcinomas Treated Using SIRT

Study Overview
=================
Brief Summary
-----------------
The aim of our study is to analyze pathological analysis of surgically treated aggressive hepatocellular carcinomas after radio-embolization. The investigators aim to demonstrate that a higher dose results in better tumor response while respecting safety conditions, that is, no radiologically induced liver disease.

Official Title
-----------------
Pathological Results After Downstaging of Agressive Hepatocellular Carcinoma Using 90Y-SIRT With Personalized Dosimetry

Conditions
-----------------
Hepatocellular Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - aggressive hepatocellular carcinomas with vascular invasion, large tumors or multifocal distribution Exclusion criteria: Other treatment after SIRT (confounding effect) contraindications for surgery

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 |
| --- | --- | --- |
| Pathological tumor response | Patients are treated with SIRT, then if the tumor response was adequate, surgery was performed.Analysis after surgery. (6 months after SIRT) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Healthy liver hypertrophia | Rate of Healthy liver hypertrophia | day 1 |
Study of Early Versus Delayed Carotid Endarterectomy (CEA) for Small to Medium-sized Ischemic Stroke Caused by High-grade Carotid Stenosis

Study Overview
=================
Brief Summary
-----------------
Pilot study of early versus delayed carotid endarterectomy (CEA) for small to medium-sized ischemic stroke caused by high-grade carotid stenosis.

Detailed Description
-----------------
Pilot study of early versus delayed carotid endarterectomy (CEA) for small to medium-sized ischemic stroke caused by high-grade carotid stenosis.

Official Title
-----------------
Pilot Study of Early Versus Delayed Carotid Endarterectomy (CEA) for Small to Medium-sized Ischemic Stroke Caused by High-grade Carotid Stenosis

Conditions
-----------------
Stroke, Carotid Stenosis

Intervention / Treatment
-----------------
* Procedure: carotid endarterectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 and older. New small to medium-sized ischemic stroke (defined as less than 1/3 of the MCA territory) in the territory of 70% or greater carotid stenosis. Women of child-bearing potential will be included only if there is a negative pregnancy test and they agree to birth control during the treatment period. Exclusion Criteria: Patients judged to be a poor surgical candidate by the treating physicians. Unstable neurological status.

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: Early<br>Early | Procedure: carotid endarterectomy<br> <br> |
| Active Comparator: Delayed<br>Delayed | Procedure: carotid endarterectomy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified Rankin Score |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stroke incidence |  | 90 days | 
| transient ischemic attack incidence |  | 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stroke, carotid stenosis, carotid endarterectomy, timing
Long-term Safety and Effectiveness of Growth Hormone With GHD, TS, CRF, SGA , ISS and PWS in Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the long-term safety and effectiveness of growth hormone (Eutropin Inj./Eutropin plus Inj.) treatment with GHD (Growth Hormone Deficiency), TS (Turner Syndrome),CRF (Chronic Renal Failure), SGA (Small for Gestational Age), and ISS (Idiopathic Short Stature).

Official Title
-----------------
An Open, Multi-center, Prospective and Retrospective Observational Study to Evaluate the Long-term Safety and Effectiveness of Growth Hormone (Eutropin Inj. / Eutropin Plus Inj.) Treatment With GHD, TS, CRF, SGA, ISS and PWS in Children

Conditions
-----------------
Growth Hormone Deficiency, Turner Syndrome, Chronic Renal Failure, Small for Gestational Age, Idiopathic Short Stature

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: short stature children aged 2 years or more children with GHD,TS, CRF, SGA or ISS written informed consent from the person, person's parent or legal guardian

Ages Eligible for Study
-----------------
Minimum Age: 2 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 |
| --- | --- |
| growth hormone<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety measure : adverse event |  | up to 2 years after epiphyseal closure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effectiveness measure : difference in target height and final height |  | up to 2 years after epiphyseal closure | 
| effectiveness : difference in height velocity between Baseline and every year |  | up to 2 years after epiphyseal closure | 
| effectiveness measure : difference in height SDS for CA between baseline and every 6 months |  | up to 2 years after epiphyseal closure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GHD, TS, CRF, SGA, ISS, PWS
Late Onset Postoperative Nausea and Vomiting

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to study the effects of different combinations of antiemetics on the incidence of late onset postoperative nausea and vomiting.

Detailed Description
-----------------
The authors will study the effect of many antiemetics on the occurrence of nausea and vomiting following strabismus surgery in pediatrics.

Official Title
-----------------
Late Onset Postoperative Nausea and Vomiting Following Strabismus Surgery in Pediatric.What Combination is Better

Conditions
-----------------
Postoperative Nausea and Vomiting

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Ondansetron, Dexamethasone
* Drug: Midazolam, dexamethasone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children undergoing elective strabismus surgery under general anesthesia Exclusion Criteria: children experienced retching or vomiting children who have taken anti-emetic medications, antihistaminics, steroids, or psychoactive drugs within 24 hours before surgery

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 12 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ondansetron-Dexa group<br>Use 2 different antiemetics | Drug: Ondansetron, Dexamethasone<br>* Use of ondansetron and dexamethasone as combined antiemetics<br>* Other names: Zofran;|
| Active Comparator: Midazolam, Dexa group<br>use of midazolam and dexamethasone | Drug: Midazolam, dexamethasone<br>* use of midazolam and dexamethasone as combined antiemetic<br>* Other names: Midazolam;|
| Placebo Comparator: Placebo<br>Saline will be given | Drug: Placebo<br>* Saline<br>* Other names: saline;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of antiemetics combination |  | 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postoperative nausea and vomiting, Pediatric, Strabismus, Late onset postoperative nausea and vomiting
Clinical and Radiological Evaluation of Acoustic Neuromas With Spontaneous Shrinkage

Study Overview
=================
Brief Summary
-----------------
To evaluate the regression characteristics of this Acoustic Neuroma population using volumetric data To study the relationship between regression and clinical characteristics including tinnitus, dizziness, hearing loss, and the intrinsic characteristics of the patients.

Official Title
-----------------
Clinical and Radiological Evaluation of Acoustic Neuromas With Spontaneous Shrinkage

Conditions
-----------------
Neuroma, Acoustic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major subject (≥18 years old) Subject followed in radiology for the assessment or follow-up of neuroma between January 01, 2013 and June 30, 2018 Subject who has agreed to the use of his data for the purpose of this research Subject presenting an untreated neuroma Exclusion Criteria: Subject having expressed his opposition to participating in the study Subject followed for neuroma of other cranial pairs, Subject followed in the context of type II neurofibromatosis Subject with a treated neuroma (radiotherapy or surgery)

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 |
| --- | --- | --- |
| Measurement of tumoral volume using tridimensional reconstruction on MRI, and kinetics of decay |  | Files analyzed from January 01, 2013 to June 30, 2018 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acoustic neuroma, Vestibular schwannoma, Spontaneous shrinkage, Neoplasm regression, Volume quantification, Tridimensional measurements, Volumetric measurements
Post-marketing Surveillance on the Safety of Cabometixtm in Korean Patients

Study Overview
=================
Brief Summary
-----------------
The objective of this Post Marketing Surveillance (PMS) is to collect and describe safety and effectiveness profile of Cabometyx™ in real clinical practice setting, according to the approved labelling after the approval of marketing authorization.

Official Title
-----------------
Post-marketing Surveillance on the Safety of Cabometixtm in Korean Patients Based on Guideline for Re-examination of New Drugs

Conditions
-----------------
Renal Cell Carcinoma, Hepatocellular Carcinoma, Differentiated Thyroid Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who meet 'Indications' of label for Cabometyx™ as monotherapy Patients who are treated with Cabometyx™ for the first time according to label for Cabometyx™ as monotherapy Patients who are aged 18 years or older Patients who are willing to provide written consent after being informed of this surveillance Exclusion Criteria: Patients who are contraindicated for Cabometyx™ based on Cabometyx™ label

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 |
| --- | --- | --- |
| Number of patients experiencing Adverse Events (AEs)/ Serious Adverse Events (SAEs) after Cabometyx™ administration |  | From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks) | 
| Proportion of patients who had AEs/SAE after Cabometyx™ administration |  | From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks) | 
| Number of AEs/SAEs after Cabometyx™ administration |  | From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate |  | From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks) | 
| Progression Free Survival |  | From baseline until 21 days after the last dose of Cabometyx (up to approximately 52 weeks) |
Evaluation of FFR, WSS, and TPF Using CCTA

Study Overview
=================
Brief Summary
-----------------
To assess the feasibility of CT-derived computed fractional flow reserve (FFRCT), wall shear stress and total plaque force on coronary atherosclerotic plaque and to collect the preliminary data to apply those parameters for the prediction of clinical outcomes in patients with coronary artery stenosis.

Official Title
-----------------
Noninvasive Evaluation of Ischemia Causing Coronary Stenosis, Wall Shear Stress, and Total Plaque Force Using Coronary CT Angiography (CCTA) and Physics-based Analytic Model Derived From Conservation of Energy

Conditions
-----------------
To Assess the Feasibility of CT-derived FFR, WSS and TPF on Coronary Atherosclerotic Plaque

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutive patients with available CCTA within 3 months of invasive angiography and invasive imaging methods (IVUS or OCT) Exclusion Criteria: Poor CT images (unable to reconstruct 3 dimensional coronary artery model)
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 with coronary artery stenosis<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CT-derived computed fractional flow reserve |  | at time of evaulation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wall shear stress |  | at time of evaulation | 
| total plaque force |  | at time of evaulation |
Prevention of Posttraumatic Stress Symptoms and Behavioral Problems in Children After Road Traffic Accidents: a Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the effectiveness of an early psychological intervention 7-10 days after a road traffic accident on posttraumatic stress and behavior of children and adolescents

Detailed Description
-----------------
Within a randomized controlled design the effects of a brief psychological intervention (child, parents) after a road traffic accident shall be examined in a sample of 100 children and adolescents. After a baseline assessment 7-10 days after the accident participants are randomly assigned to an intervention or a control group. Both are re-assessed at 2 and 6 months after the accident by means of standardized questionnaires assessing posttraumatic stress symptoms, depression, and behavior.

Official Title
-----------------
Prevention of Posttraumatic Stress Symptoms and Behavioral Problems in Children and Adolescents After Road Traffic Accidents: a Randomized Controlled Trial

Conditions
-----------------
Injury

Intervention / Treatment
-----------------
* Behavioral: Early psychological intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 7-16 y Command of German language Road traffic accident inpatient or outpatient treatment at the University Children's Hospital Zurich no pretraumatic developmental delay Exclusion Criteria: severe head injury No command of the German language Age below 7 y or above 16 y Other major systemic illness

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 16 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Early psychological intervention|Psychoeducation, trauma narrative, provision of coping skills|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CAPS-CA |  | 10 days, 2 months, 6 months after intervention | 
| CBCL |  | 10 days, 2 months, 6 months after intervention | 
| DIKJ |  | 10 days, 2 months, 6 months after intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
posttraumatic stress disorder, children, injury, road traffic accident