linjc16/ctgov huggingface dataset:
Pre- and Post-operative Brain MRI in Carotid Endarterectomy

Study Overview
=================
Brief Summary
-----------------
Patients undergoing carotid endarterectomy in the Department of Vascular Surgery at Oslo University Hospital are consecutively included in this evaluation og pre- and postoperative brain MRI.

Detailed Description
-----------------
Patients undergoing surgery for carotid stenosis in our Department are examined by brain MRI before and after carotid surgery to evaluate the rationale for the MRI. Brain lesions on MRI before and after carotid surgery are registered, and related to clinical findings. The purpose of the study is to evaluate whether brain MRI in relation to carotid endarterectomy gives additional information to clinical findings, and to CT scan of the brain.

Official Title
-----------------
Evaluation of Pre- and Post-operative Brain MRI in Carotid Endarterectomy

Conditions
-----------------
Carotid Artery Stenoses

Intervention / Treatment
-----------------
* Diagnostic Test: Brain MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication for carotid surgery Exclusion Criteria: Contraindications to MRI
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Brain MRI|Brain MRI diagnoses tromboembolic lesions or bleeding to the cerebrum and is part of preoperative diagnostic tests before carotid surgery. After surgery brain MRI may present New lesions related to surgery, clinically significant or insignificant. Our goal is to evaluate the relevance of this modality in carotid surgery..|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain lesions on MRI | Lesions on brain MRI representing thromboembolic or hemorrhagic episodes | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from Transient Ischemic Attack (TIA) or minor stroke to surgery | International guidelines recommends surgery within 14 days after TIA | Days before surgery, maximum 6 months |
Assessment of the Occlusal Characteristics

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to assess the occlusal characteristics of primary dentition among Egyptian preschool children.

Detailed Description
-----------------
This cross-sectional study was based on examination of the primary dentition of healthy preschool Egyptian children ,The objective of this study is to assess the occlusal characteristics of primary dentition among Egyptian preschool children.

Official Title
-----------------
Assessment of the Occlusal Characteristics of the Primary Dentition Among Egyptian Pre-School Children

Conditions
-----------------
Tooth Development Disorder

Intervention / Treatment
-----------------
* Other: clinical examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Egyptian children. Children are medically free. Children with a complete set of primary dentition without any permanent teeth. -Teeth free of extensive caries which affect the mesio- distal and occluso- gingival dimension. Exclusion Criteria: Children with developmental anomalies. Children with any oral habits. Children with cognition problems. Children with a history of an obvious alternative cause for malocclusion (e.g. trauma, syndromes). Participant's caregivers refuse to give consent.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 6 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: clinical examination|Clinical examination with optimal (Lighting, using a disposable mouth mirror and a millimeter-ruler) will be performed, in addition to an upper and lower arch impression will be made and a study cast will be prepared.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary molar relationship | Categorical (Flush terminal plane, mesial step, distal step) | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary canine relationship | Categorical (Class 1, Class 2, Class3) | Day 1 | 
| Physiological spaces (Upper and lower) | Binary (Present/absent) | Day 1 | 
| Primate spaces (Upper and lower) | Binary (Present/absent) | Day 1 | 
| Crowding (upper and lower) | Binary (Present/absent) | Day 1 | 
| Midline discrepancy | Binary (Present/absent) | Day 1 | 
| Posterior Crossbite (unilateral/bilateral) | Binary (Present/absent) | Day 1 | 
| Degree of overbite | Categorical (Normal, increased, edge to edge or anterior open bite) | Day 1 | 
| Degree of overjet | Categorical (Normal, increased, edge to edge or anterior crossbite) | Day 1 |
Detection of Early Esophageal Squamous Neoplasia

Study Overview
=================
Brief Summary
-----------------
The aim of the present study： To investigate the diagnosing value of pCLE for early esophageal squamous neoplasia. To assess the detection rate of early esophageal squamous neoplasia by virtual chromoendoscopy

Detailed Description
-----------------
Probe-based confocal laser endomicroscopy (pCLE; Cellvizio, Mauna Kea Technologies, Paris, France) is a newly developed endoscopic device and has shown its value for diagnosing Barrett's esophagus, colonal polyps and etc. However, none research has focus on early esophageal squamous neoplasia until now. Previous diagnosis of early esophageal neoplasia is based on the lugol staining which is time wasting and have many adverse events.Other researches have suggested virtual chromoendoscopys are beneficial for screening esophageal tumors. Therefore, the aim of the present study is 1.To investigate the diagnosing value of pCLE for early esophageal squamous neoplasia according to the surface maturation scoring(SMS) diagnostic criteria and 2. To assess the detection rate of early esophageal squamous neoplasia by virtual chromoendoscopy(I-SCAN).

Official Title
-----------------
Detection of Early Esophageal Squamous Neoplasia by Using Virtual Chromoendoscopy and Probe-based Confocal Laser Endomicroscopy

Conditions
-----------------
Esophageal Squamous Intraepithelial Neoplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged between 50 and 80 years old Patients undergo screening endoscopy or histologically verified esophageal squamous intraepithelial neoplasia before. Exclusion Criteria: Advanced esophageal, gastric or duodenal cancer History of upper GI tract surgery Coagulopathy or acute GI bleeding Pregnant or breast-feeding (for females) Impaired renal function Allergy to fluorescein sodium Inability to provide informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 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 |
| --- | --- |
| pCLE examination<br>pCLE is used to distinguish the suspected lesions detected by I-SCAN in esophagus | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The diagnostic accuracy of pCLE on early esophageal squamous neoplasia | Patients will be prospectively recruited to evaluate the diagnostic sensitivity, specificity and accuracy of early esophageal squamous neoplasia by using probe-based confocal laser endomicroscopy | 6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Esophageal Squamous Intraepithelial Neoplasia, surface maturation scoring, probe-based confocal laser endomicroscopy, virtual chromoendoscopy
Efficacy and Safety of Nateglinide Treatment in Renal Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
The objective of the present study is to evaluate both the efficacy and safet of nateglinide in renal transplanta recipients with posttransplant diabetes mellitus or impaired glucose tolerance. Primarily will the change in glucose tolerance and acute insuline responce be addressed.

Official Title
-----------------
Efficacy and Safety of Nateglinide Treatment in Renal Treatment Recipients With Post Transplant Diabetes Mellitus or Impaired Glucose Tolerance

Conditions
-----------------
Renal Transplant Recipients, Posttransplant Diabetes Mellitus, Posttransplant Impaired Glucose Tolerance

Intervention / Treatment
-----------------
* Drug: Nateglinide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Reduced glucose tolerance (fasting glucose < 6.1 mmol/L AND 2 hour glucose between 6.7 and 9.9 mmol/L) or posttransplant diabetes mellitus (fasting glucose > 6.1 mmol/L OR 2 hour glucose between >= 10.0 mmol/L) Stable patients fgollowing renal transplantation, less than 25% variation in serum creatinine last week and serum creatinine < 200 micromol/L Exclusion Criteria: Patients with indulin dependent diabetes mellitus before or after transplantation Planned change in daily prednisolone dose during the study period Haemoglobin < 8g/dL

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nateglinide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose tolerance |  |  | 
| Insuline release |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose oxidation |  |  | 
| Postprandial hyperlipidemia |  |  | 
| Glomerular filtration rate |  |  | 
| HbA1C |  |  | 
| Fasting glucose |  |  | 
| Plasma nitric oxide |  |  | 
| Plasma endothelin-1 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nateglinide, Renal, Kidney, Transplantation, Diabets, Glucose
Study of Association Between Maternal Uric Acid , Maternal and Fetal Outcome in Pregnant Women With Hypertension

Study Overview
=================
Brief Summary
-----------------
Association of maternal uric acid with maternal condition and fetal outcome in pregnant women with hypertension.

Detailed Description
-----------------
Association of maternal uric acid with maternal condition(renal function,liver function,...ect.) and fetal outcome(birth weight,APGER score) in pregnant women with hypertension.

Official Title
-----------------
Association of Maternal Uric Acid With Maternal Condition and Fetal Outcome in Pregnant Women With Hypertension

Conditions
-----------------
Uric Acid and Hypertension in Pregnancy

Intervention / Treatment
-----------------
* Other: measuring protein creatinin ratio,serum uric acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age:18-40 years old Gestational age:28-42 weeks gestation singleton pregnancy of living fetus Non smoker Exclusion Criteria: women who refuse the study Any medical or obstetric disorders especially D.M.,renal disease,hepatic, cardiac disorders or gout arthritis, other than hypertension if present. Previously elevated uric acid level. Hemolytic or sickle cell anemia,urinary tract infection. Use of diuretics or anti-inflammatory drugs.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- |
| A<br>40 pregnant Women with hypertension who have uric acid level more than 6 mg per dL. | Other: measuring protein creatinin ratio,serum uric acid<br>* A non-deproteinized Jaffe reaction is employed to measure creatinine and urinary protein measured by an automated colorimetric assay using pyrogallol red and sodium molybdate. Measuring of serum uric acid by(2,4,6-tribromo-3-hydroxybenzoic acid)TBHBA by uricase method.<br>|
| B<br>40 pregnant women with hypertension who have uric acid level less than 6 mg per dl. | Other: measuring protein creatinin ratio,serum uric acid<br>* A non-deproteinized Jaffe reaction is employed to measure creatinine and urinary protein measured by an automated colorimetric assay using pyrogallol red and sodium molybdate. Measuring of serum uric acid by(2,4,6-tribromo-3-hydroxybenzoic acid)TBHBA by uricase method.<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
-----------------
Uric acid
LUKS-Leads Registry on Long-term Performance of ICD Leads

Study Overview
=================
Brief Summary
-----------------
All patients having an implantable cardiac defibrillator (ICD) implanted and having follow-up at the Cantonal Hospital Lucerne (LUKS), the investigator center, are included in this retrospective ICD lead registry from 2006 onwards. Data is collected prospectively from december 2016 onwards. After certain ICD-leads tended to fail early the investigators aimed for a registry monitoring our patient population with defibrillator leads and evaluating their long-term performance.

Detailed Description
-----------------
All patients having an ICD implanted and having follow-up at the investigators center are included in this retrospective ICD lead registry from 2006 onwards. Data is collected prospectively from december 2016 onwards. After certain ICD-leads tended to fail early the investigators aimed for a registry monitoring our patient population with defibrillator leads and evaluating their long-term performance. The following parameters will be measured during regular clinical controls: electronic impedances, threshold values, sensing values, battery performance, inadequate/adequate shock release und software problems

Official Title
-----------------
LUKS-Leads Registry on Long-term Performance of ICD Leads

Conditions
-----------------
Defibrillators, Electrical Shock

Intervention / Treatment
-----------------
* Device: defibrillator lead


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients being implanted with a Defibrillator lead from 2006 onwards Exclusion Criteria: documented refusal of data collection for scientific purposes
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| implanted defibrillator lead<br>patients having an ICD implanted and having follow-up at the investigators center | Device: defibrillator lead<br>* observation of long-term performance of defibrillator leads<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| performance of lead impedance | electronic impedances in Ω | regular clinical controls within 10 years | 
| performance of lead threshold | threshold values in V | during regular clinical controls within 10 years | 
| performance of lead sensing | sensing values in millivolt (mV) | during regular clinical controls within 10 years | 
| lead parameters | battery performance in % | during regular clinical controls within 10 years | 
| performance of defibrillator | inadequate/adequate shock release in numbers | during regular clinical controls within 10 years | 
| control system of defibrillator | software problems in numbers and descriptive | during regular clinical controls within 10 years |
Radiation Therapy in Uterine Cancer: Dosimetry Analysis, Clinical Implication, and Survival Analysis

Study Overview
=================
Brief Summary
-----------------
We wish to study radiation therapy in uterine cancer, focusing on dosimetry analysis, clinical implication, and survival analysis.

Detailed Description
-----------------
We wish to study radiation therapy in uterine cancer, focusing on dosimetry analysis, clinical implication, and survival analysis.

Official Title
-----------------
Radiation Therapy in Uterine Cancer: Dosimetry Analysis, Clinical Implication, and Survival Analysis

Conditions
-----------------
Endometrial Cancer

Intervention / Treatment
-----------------
* Other: Observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with uterine cancer (stage I - IV) treated in National Taiwan University Hospital, from January 2010 to September 2019. Exclusion Criteria: Women with uterine cancer (stage I - IV) NOT treated in National Taiwan University Hospital, from January 2010 to September 2019.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Observational study|Observational study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival | Progression free survival: The time from inclusion to documented disease progression according to RECIST v1.1 or death from any cause. | 5 years |
A Study to Assess the Safety and Pharmacokinetics of an Inhibitor of PARP in Combination With Dacarbazine

Study Overview
=================
Brief Summary
-----------------
This is a Phase I, open-label, dose-escalating, study of the safety and tolerability of KU-0059436 in combination with DTIC in the treatment of patients with advanced melanoma who have not previously received systemic cytotoxic chemotherapy.

Official Title
-----------------
A Phase I, Open Label, Study of the Safety and Tolerability of KU-0059436 and Dacarbazine in the Treatment of Patients With Advanced Solid Tumours

Conditions
-----------------
Melanoma Neoplasms

Intervention / Treatment
-----------------
* Drug: KU-0059436 (AZD2281)(PARP inhibitor)
* Drug: dacarbazine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have: Unresectable stage 3 or stage 4 cutaneous melanoma or unknown primary melanoma with metastases. Histological or cytological confirmation of melanoma. Histological confirmation of melanoma from the primary site will suffice, unless the primary site is unknown. Exclusion Criteria: Previous treatment with cytotoxic chemotherapy for advanced melanoma, apart from treatment for melanoma with isolated limb perfusion. Radiotherapy (except for palliative reasons), endocrine therapy, immunotherapy or use of other investigational agents within 4 weeks prior to trial entry (or a longer period depending on the defined characteristics of the agents used). Major surgery within 4 weeks of starting the study.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>DTIC + KU-0059436 | Drug: KU-0059436 (AZD2281)(PARP inhibitor)<br>* oral<br>* Other names: Olaparib;Drug: dacarbazine<br>* intravenous injection over at least 20 minutes<br>* Other names: DTIC;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the safety, tolerability, dose-limiting toxicity (DLT), and (MTD) of KU-0059436 in combination with dacarbazine. |  | assessed every 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective tumour response |  | assessed every 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Poly(ADP ribose) polymerases, dacarbazine