linjc16/ctgov huggingface dataset:
Aneurysmal Bone Cyst Imaging After Interventional Radiology Treatment

Study Overview
=================
Brief Summary
-----------------
This study aims to describe the clinical outcomeand the radiological appearance of aneurysmal bone cyst treated by means of interventional radiology procedures (percutaneous sclerosis and endovascular embolization)

Official Title
-----------------
Aneurysmal Bone Cyst Imaging After Interventional Radiology Treatment: Clinical and Radiological Outcome

Conditions
-----------------
Bone Cysts

Intervention / Treatment
-----------------
* Other: radiology


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Male of female Aging from 0 to 30 years With typical aneurysmal bone cyst at initial imaging At least one interventional radiology procedure performed Exclusion criteria: No initial surgery Patient refuses to participate

Ages Eligible for Study
-----------------
Minimum Age: 0 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 |
| --- | --- |
| Aneurysmal bone cyst<br>Patient aging from 0 to 30 years with diagnosis of aneurysmal bone cyst treated by percutaneous alcolisation or endovascular embolization. | Other: radiology<br>* Interventional radiology for aneurysmal bone cyst ( percutaneous alcoholization, vascualr embolisation)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of size lesion after treatement | Percentage of peripheral reossification after treatment : 0%: no reossification < 25%: low reossification Between 25% -50%: Partial reossification Between 50-75%: significant reossification > 75%: very significant reossification 100%: complete reossifcation | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of pain | Pain measured with Pain scale ( 0 = no pain , 10 = maximum pain) | day 1 | 
| number of deficience | Number of patients needs second treatment 3- Fracture ? (yes or no) | day 1 | 
| number of complication | Fracture ? (yes or no) | day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radiology, Interventional, Epidemiology, Vascualr embolisation, Percutaneous alcoholization, Aneurysmal bone cyst
Effect on Music Therapy on Quality of Recovery After Gynecological Laparoscopy

Study Overview
=================
Brief Summary
-----------------
In the present study, we intended to evaluate the effect of music intervention on postoperative pain, nausea, and comprehensive recovery quality in patients undergoing gynecological laparoscopic surgery.

Official Title
-----------------
Effect on Music Therapy on Quality of Recovery and Postoperative Pain After Gynecological Laparoscopy

Conditions
-----------------
Quality of Recovery After General Anesthesia, Post Operative Pain

Intervention / Treatment
-----------------
* Other: music
* Other: control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status classification I and II, undergoing gynecological laparoscopic surgery Exclusion Criteria: Any hearing impairment, Known psychiatric or memory disorder Alcohol or analgesics abuse Inability to complete quesationnaires

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: music intervention<br>Headphone was placed on the each patient. The classical music was started to the patients with individual comfortable volume. | Other: music<br>* Classical music pre-selected was started to the patients with individual comfortable volume.<br>|
| Placebo Comparator: control<br>Headphone was placed on the each patients, but the music player was not started. | Other: control<br>* music player was not started.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery quality | Patient-reported survery, quality of recovery 40 (QoR 40): sum scores range from 40 to 200 (40; poor   200; excellent quality of recovery) | At postoperative day, 1 | 
| Postoperative pain | Numeric rating scale (NRS, 0-10)O; no pain   10; the most severe pain | 36 hours after surgery |
Audit of International Intraoperative Hemotherapy and Blood Loss Documentation

Study Overview
=================
Brief Summary
-----------------
The investigator hypotheses anesthetic records do not contain detailed information on hemotherapy and blood loss estimation. Therefore anesthetic records will be collected from different institutions and analyzed for items concerning hemotherapy contained.

Detailed Description
-----------------
The anaesthetic record is the primary way anesthetists document and communicate information regarding hemotherapy. Records vary in content and design. Several organizations published recommendations, but perioperative hemotherapy is not sufficiently detailed for the purpose. Anesthetic records will be analyzed for 20 defined hemotherapy and monitoring items by two independent investigators. Disagreements will be resolved by a the principle investigator.

Official Title
-----------------
Audit of International Intraoperative Hemotherapy and Blood Loss Documentation

Conditions
-----------------
Patient Safety, Patient Blood Management

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Anesthetic records Exclusion Criteria: Incomplete records
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contained items in anesthetic records | The main outcome measure are hemotherapy-items in anesthetic records | 11/01/2019 - 12/01/2019 |
A Follow-up Study to Evaluate the Safety of RetinoStat® in Patients With Age-Related Macular Degeneration

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the long term safety of an experimental gene transfer agent, RetinoStat®, designed to treat neovascular age-related macular degeneration.

Official Title
-----------------
A Long Term Follow-up Study to Evaluate the Safety of RetinoStat® in Patients With Age-Related Macular Degeneration

Conditions
-----------------
Age-Related Macular Degeneration

Intervention / Treatment
-----------------
* Drug: RetinoStat


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have received a subretinal injection of RetinoStat Must have been enrolled in Protocol RS1/001/10 Exclusion Criteria: Did not receive RetinoStat® as part of the RS1/001/10 protocol

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Long Term Follow up<br>Long Term follow up of patients who received RetinoStat in a previous study. | Drug: RetinoStat<br>* Long Term Follow up of patients who received RetinoStat in a previous study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of adverse events | The number of subjects with treatment emergent adverse events. | 15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from baseline in BCVA. | The change from baseline in Best Corrective Visual Acuity. | 15 years |
Expanded Access to Navitoclax

Study Overview
=================
Brief Summary
-----------------
This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to navitoclax prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

Official Title
-----------------
Expanded Access to Navitoclax

Conditions
-----------------
Myelofibrosis, Acute Lymphocytic Leukemia (ALL), Lymphoblastic Lymphoma

Intervention / Treatment
-----------------
* Drug: Navitoclax
* Drug: Venetoclax


Participation Criteria
=================

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


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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Navitoclax|Tablet, Oral|
|Drug: Venetoclax|Tablet, Oral|

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
-----------------
Expanded Access, Pre-approval Access, Compassionate Use, Special Access Program, Named Patient Basis, Special Access Scheme
Vitamine d Dosage and Constipation

Study Overview
=================
Brief Summary
-----------------
Vitamine d dosage in important to define nutritional status and bone metabolism. For patients with intestinal disorders it is important to establish the intestinal absorptive function. It is important to establish the absorption of vitamin D which correlate with different biological activity and bone metabolism, immune function and the communication between the cells.

Detailed Description
-----------------
Constipation is a disease that involves poor intestinal functioning. The reduced intestinal motility slows down intestinal function. Up to make lower the dosage of vitamin D. Vitamin D helps many cellular activities and enhances the action of tissue,Its Your dosage allows you to evaluate the efficacy of intestinal function and to better understand its severity.

Official Title
-----------------
Vitamine D Deficiency in Slow Transit Time Constipation

Conditions
-----------------
Vitamine d Dosage in Slow Transit Time Constipation

Intervention / Treatment
-----------------
* Diagnostic Test: vitamine d dosage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: slow transit time constipation Exclusion Criteria: drugs assumption comorbidity

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 75 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 |
| --- | --- |
| slow transit time constipation<br> | Diagnostic Test: vitamine d dosage<br>* dosage of vitamine D in slow transit time constipation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dosage of vitamine D | dosage of vitamine d in slow transit time constipation | 4 months |
Concentrations of Formoterol in Blood and Urine

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess the blood and urine concentrations of inhaled formoterol.

Detailed Description
-----------------
The purpose of the study is to assess the serum and urine concentrations after inhalation of 18 microgram formoterol as one dose. Furthermore to investigate the serum and urine concentrations of inhaled formoterol and evaluate the difference between three groups: healthy men, male asthmatic subjects and male elite athletes with asthma.

Official Title
-----------------
Blood and Urinary Concentrations of Inhaled Formoterol in Asthmatic Subjects and Elite Athletes With Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: inhaled formoterol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Physician-diagnosed asthma with positive reversibility or challenge test. Informed consent. Age between 18-45 years. Sex: male. Asthma classified as mild to moderate according to GINA guidelines. Used beta-2-agonist in minimum 12 months. Exclusion Criteria: Smokers or ex-smokers with a smoking history of 10 pack years or more. Respiratory tract infections within the last 2 weeks prior to study day. Subjects with other chronic diseases than asthma and allergy. Allergy towards the study medicine. Use of beta-2-agonist 10 days prior to study day.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthty<br>10 healthy men | Drug: inhaled formoterol<br>* Inhalation of 18 microgram formoterol as one dose. Oxis Turbohaler 9 microg/dose, MA no. 30072.<br>* Other names: Oxis Turbohaler 9 microg/dose, MA no. 30072.;|
| Other: Asthmatics<br>10 male asthmatic subjects | Drug: inhaled formoterol<br>* Inhalation of 18 microgram formoterol as one dose. Oxis Turbohaler 9 microg/dose, MA no. 30072.<br>* Other names: Oxis Turbohaler 9 microg/dose, MA no. 30072.;|
| Other: Elite asthmatics<br>10 male elite athletes with asthma | Drug: inhaled formoterol<br>* Inhalation of 18 microgram formoterol as one dose. Oxis Turbohaler 9 microg/dose, MA no. 30072.<br>* Other names: Oxis Turbohaler 9 microg/dose, MA no. 30072.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum and urine concentrations of formoterol |  | baseline, 4, 8, and 12 hours after medicine administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Doping, Formoterol, Urinary concentrations, Beta-agonists
Ketamine Combination With Spinal Morphine for Post Thoracic Surgery Pain : A Randomized Control Study

Study Overview
=================
Brief Summary
-----------------
Thoracotomy is one of the most painful operation. Continuous thoracic epidural or paravertebral analgesia are gold standard for postoperative pain. But both techniques require skills. Spinal morphine is alternative simple method with less efficacy. Adding low dose ketamine during intraoperative may be helpful in postoperative pain relief.

Official Title
-----------------
Low Dose Intraoperative Intravenous Ketamine Combination With Spinal Morphine for Post Thoracic Surgery Pain : A Randomized Control Study

Conditions
-----------------
Pain, Postoperative Period

Intervention / Treatment
-----------------
* Other: NSS
* Drug: Ketamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA physical status 1-3 elective thoracotomy can operate patient-controlled analgesia (PCA) machine Exclusion Criteria: patient with history of allergy to morphine or ketamine contraindicate to ketamine remain intubated in the postoperative period

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Placebo Comparator: Control<br>NSS infusion | Other: NSS<br>* NSS infusion<br>|
| Experimental: Ketamine<br>Ketamine 0.2 mg/kg/hr intravenous infusion | Drug: Ketamine<br>* Ketamine 0.2 mg/kg/hr intravenous infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first trigger of morphine | Time to first trigger of morphine | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hr morphine consumption | 24-hr morphine consumption | 24 hours | 
| NRS score at 6, 24 hours | NRS score (0-10) was assessed at at 6, 24 hours postoperative | 24 hours | 
| Incidence of nausea and vomiting | Incidence of nausea and vomiting | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thoracotomy, Postoperative pain, Ketamine
ZD6474 Alone or in Combination With Paclitaxel and Carboplatin in Subjects With Previously Untreated Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

Study Overview
=================
Brief Summary
-----------------
The purpose of the run-in phase of this study is to determine the appropriate and tolerable dose of ZD6474 (200mg or 300mg) to be administered in combination with paclitaxel and carboplatin in subjects with previously untreated locally advanced or metastatic NSCLC. This phase of the trial is closed to enrollment. The purpose of the randomized phase of this study is to determine the efficacy of ZD6474 alone versus that of ZD6474 in combination with paclitaxel and carboplatin versus that of paclitaxel and carboplatin alone in subjects with previously untreated locally advanced or metastatic NSCLC. This phase of the trial is closed to enrollment.

Official Title
-----------------
A Randomized, Partially Blinded, Phase II Study to Assess the Safety, Tolerability and Efficacy of ZD6474 Alone or in Combination With Paclitaxel and Carboplatin in Subjects With Previously Untreated Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
-----------------
* Drug: ZD6474
* Drug: Paclitaxel
* Drug: Carboplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent 18 years or older Histologically or cytologically confirmed locally advanced or metastatic NSCLC No prior chemotherapy/biological therapy/radiation therapy One or more measurable lesions Life expectancy more than 12 weeks Exclusion Criteria: Brain metastases or spinal cord compression Currently active skin disease History of significant hemoptysis Abnormal blood chemistry Cardiac abnormalities Recent significant cardiac event Coexisting malignancies

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

| Intervention/Treatment |
| --- |
|Drug: ZD6474|nan|
|Drug: Paclitaxel|nan|
|Drug: Carboplatin|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
-----------------
Non-Small-Cell Lung Carcinoma
A Study Examining Torcetrapib/Atorvastatin And Atorvastatin Effects On Clinical CV Events In Patients With Heart Disease

Study Overview
=================
Brief Summary
-----------------
The Torcetrapib project was terminated on December 2, 2006 due to safety findings. To demonstrate if torcetrapib/atorvastatin can reduce the risk for major cardiovascular disease events, when compared to atorvastatin alone, in patients with coronary heart disease or risk equivalents

Official Title
-----------------
Phase 3 Multi Center, Double Blind, Randomized, Parallel Group Evaluation Of The Fixed Combination Torcetrapib/Atorvastatin, Administered Orally, Once Daily (Qd), Compared With Atorvastatin Alone, On The Occurrence Of Major Cardiovascular Events In Subjects With Coronary Heart Disease Or Risk Equivalents

Conditions
-----------------
Coronary Disease, Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: torcetrapib/atorvastatin
* Drug: atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of coronary heart disease or risk equivalents that place the patient at high risk for cardiovascular disease events Exclusion Criteria: Women who are pregnant or lactating, or planning to become pregnant. Subjects with a clinically indicated need for statin (HMG-CoA reductase inhibitor) therapy other than atorvastatin or other concomitant therapy with known lipid altering effects on LDL-C and HDL-C including fibrates and nicotinic acid Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors Subjects with any other medical condition or laboratory abnormality which could affect subject safety, preclude evaluationof response, or render unlikely that the subject would complete the study

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 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

| Intervention/Treatment |
| --- |
|Drug: torcetrapib/atorvastatin|nan|
|Drug: atorvastatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time to first occurrence of a major cardiovascular disease event |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Various composites of major cardiovascular disease events and other lipid parameters |  |  |