linjc16/ctgov huggingface dataset:
Evaluating the Accuracy of Navigation Assisted Pedicle Screw Placement of Spine Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the difference of the accuracy and safety between traditional spine surgery and computer assisted navigation system spine surgery.

Detailed Description
-----------------
The object of study is the patients who are going to undergo pedicle screw fixation operation. there are two clinical trial centers.one is beijing jishuitan hospital,the other is beijing shuili hospital.the study protocol will be reviewed by the Ethics Committee of Beijing Jishuitan Hospital. after the patients sign the informed consent,they will be divided into two groups randomly.the patients' basic information and medical informations including the accuracy and safety will be collected.the data above all will be compared.

Official Title
-----------------
A Multi-center Randomized Controlled Trial Evaluating the Accuracy of Navigation Assisted Pedicle Screw Placement of Spine Surgery

Conditions
-----------------
Pedicle Screw of Fixation

Intervention / Treatment
-----------------
* Procedure: navigation assisted spine surgery
* Procedure: traditional spine surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who need to undergo pedicle screw fixation surgery Sign informed consent Capacity person Exclusion Criteria: refused to sign the informed consent the age is not between 18 and 75 years old

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: navigation assisted spine surgery<br> | Procedure: navigation assisted spine surgery<br>* navigation assisted pedicle screw placement of spine surgery<br>* Other names: navigation assisted pedicle screw placement of spine surgery;Procedure: traditional spine surgery<br>* traditional spine surgery without navigation assist<br>* Other names: traditional spine surgery without navigation assist;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the accuracy of pedicle screw | one week after the spine surgery,measure the accuracy of pedicle screw by CT examination | one week after the spine surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complication | the complication would be recorded three days after the spine surgery | three days after the spine surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pedicle screw of fixation operation, spine surgery, navigation assisted
MK0476 Study in Adult Patients With Acute Asthma (0476-322)

Study Overview
=================
Brief Summary
-----------------
This study evaluates the efficacy and safety of MK0476 intravenous administration in adult patients with acute asthma.

Official Title
-----------------
MK0476 Phase II/III Placebo Controlled Double Blind Study

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

Intervention / Treatment
-----------------
* Drug: montelukast sodium
* Drug: Comparator: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult Patients With Acute Asthma Attacks Exclusion Criteria: Patient Has Any Known Or Suspected, Acute Or Chronic Cause For Their Pulmonary Symptoms Other Than Asthma (E.G., Copd, Chronic Heart Failure, Etc.) Patient Has A Smoking History (20 Cigarettes Per Day) Of More Than 15 Years Patient Has A Disease Of The Cardiovascular, Hepatic, Renal, Hematologic Systems, Or Other Severe Disease

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- |
| Experimental: 1<br>Placebo | Drug: Comparator: Placebo<br>* Placebo single injection<br>|
| Experimental: 2<br>MK0476 7 mg injection | Drug: montelukast sodium<br>* 7 mg or 14 mg single injection<br>|
| Experimental: 3<br>MK0476 14 mg injection | Drug: montelukast sodium<br>* 7 mg or 14 mg single injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Time-weighted Average of Change in Forced Expiratory Volume in One Second (FEV1) | The Time Weighed Average Changes in Forced Expiratory Volume in One Second (FEV1) from pre-allocation baseline over the first 60 minutes after study drug administration with time interval between any measurement and the measurement prior to it is used as the weighting factor | baseline over the first 60 minutes |
Study to Evaluate Viagra's Ability to Provide a Better Sexual Experience Through Quality Erections and Satisfaction

Study Overview
=================
Brief Summary
-----------------
The study objective is to: To evaluate the effect of sildenafil citrate versus placebo on the IIEF_EF Domain at the end of the double-blind phase To assess the relationship between treatment with sildenafil citrate or placebo and responses to the Quality of Erection Questionnaire (QEQ) and Sexual Experience Questionnaire (SEX_Q).

Official Title
-----------------
A Multicenter, Double-Blind Placebo Controlled, Fixed Dose Study With An Open-Label, Flexible Dose Phase To Assess The Efficacy Of Sildenafil Citrate In Providing A Better Sexual Experience Including Quality Of Erections And Satisfaction In Men With Erectile Dysfunction

Conditions
-----------------
Impotence

Intervention / Treatment
-----------------
* Drug: Sildenafil Citrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male subjects aged 18-65. Documented clinical diagnosis of erectile dysfunction confirmed by an IIEF-EF Domain score of less than or equal to 25. (If the subject scores greater than 25 on the IIEF-EF Domain, screening procedures should be terminated.) Exclusion Criteria: Subjects who have been treated with more than 6 doses of sildenafil citrate or any other phosphodiesterase type 5 (PDE-5) inhibitor such as vardenafil or tadalafil for erectile dysfunction [Note: subjects should not have taken any PDE-5 inhibitors within 4 weeks prior to the date of screening].

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

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

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: Sildenafil Citrate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is the change from baseline to Visit 4 (Week 8) in the IIEF Erectile Function (EF) domain score. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from baseline to visit 6 (wk 12) in the IIEF-EF domain; the change from baseline to visit 4 (wk 8) and visit 6 (wk 12) in the domains and total score as well as the individual questions of the sexual experience questionnaire |  |  |
To Demonstrate the Relative Bioavailability of Cefzil 500 mg Cefprozil Tablets Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
To demonstrate the relative bioavailability of Cefzil 500 mg Cefprozil tablets under fasting conditions.

Official Title
-----------------
Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Sandoz GmbH and Bristol-Myers Squibb (Cefzil) 500 mg Cefprozil Tablets In Healthy Adults Volunteers Under Fasting Conditions

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Cefprozil 500 mg Tablets (Sandoz GmbH)
* Drug: Cefzil (Cefprozil) 500 mg Tablets (Bristol-Myers Squibb)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: Positive test results for HIV or hepatitis B or C. Treatment for drug or alcohol dependence.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 54 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Cefprozil 500 mg Tablets (Sandoz GmbH) | Drug: Cefprozil 500 mg Tablets (Sandoz GmbH)<br> <br> |
| Active Comparator: 2<br>Cefzil (Cefprozil) 500 mg Tablets (Bristol-Myers Squibb) | Drug: Cefzil (Cefprozil) 500 mg Tablets (Bristol-Myers Squibb)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  | 16 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antibiotic
Myocardial Flow Reserve and 99mTc-DTPA Cardiac Dynamic SPECT

Study Overview
=================
Brief Summary
-----------------
New CZT-based SPECT cameras are potentially capable of dynamic 3-D acquisition. Preliminary results suggested that dynamic acquisitions could allow the assessment of myocardial flow reserve using 99mTc-labelled perfusion tracers. The Flow-Heart study will assess the feasibility of myocardial flow reserve measurement by means of 99mTc-DTPA dynamic cardiac SPECT in 20 patients.

Official Title
-----------------
Feasibility of Dynamic Cardiac SPECT With 99mTc-diethylenetriaminepenta-acetate (DTPA) for the Assessment of Myocardial Flow Reserve Using a Cadmium-Zinc-Telluride (CZT) Camera

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

Intervention / Treatment
-----------------
* Other: Cardiac SPECT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 18 years Patient clinically stable with known or suspected coronary disease Patient referred to Caen University Hospital for a myocardial perfusion SPECT Patient who accept to undergo subsequent additional cardiac dynamic SPECT using 99mTc-DTPA at rest and during pharmacological stress Informed consent dated and signed Affiliation to a social security system Exclusion Criteria: Contraindication to dipyridamole (asthma, chronic obstructive pulmonary disease , pulmonary hypertension) History of poor tolerance of dipyridamole injection Cardiac arrhythmia (atrial fibrillation or frequent premature ventricular complex) Left bundle branch block, cardiac pacemaker, or implantable automatic defibrillator Recent history of myocardial infarction or unstable angina Pregnancy or lactating women Known obstructive renal or urinary disease Age under 18 years or guardianship Patient with an acute coronary syndrome or a coronary revascularization occurring between the conventional perfusion SPECT and the subsequent 99mTc-DTPA dynamic SPECT

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardiac Dynamic SPECT<br> | Other: Cardiac SPECT<br>* 3-D dynamic acquisition of cardiac SPECT at rest and after pharmacological stress<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of myocardial flow reserve assessment by dynamic cardiac SPECT using a CZT camera and 99mTc-DTPA |  | Within one month after a conventional myocardial perfusion SPECT | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myocardial perfusion imaging, Single-Photon Emission Computer-Assisted Tomography
Stage I/II NSCLC Perioperative Chemotherapy

Study Overview
=================
Brief Summary
-----------------
The addition of chemotherapy to lung cancer surgery is now considered as the standard of care. Solid data support postoperative chemotherapy but only few results are available in the preoperative setting. To define which timing of perioperative chemotherapy offers the best survival improvement, the IFCT 0002 study is conducted in France.

Detailed Description
-----------------
In this multicenter study, patients are randomized to receive either two preoperative chemotherapy cycles plus two additional preoperative cycles if they respond to chemotherapy, or two preoperative plus two postoperative cycles in case of response.

Official Title
-----------------
Phase III Trial Comparing 2 Chemotherapy Schedules (Preoperative vs Pre and Postoperative) in Stage I and II NSCLC

Conditions
-----------------
Non-small Cell Lung Cancer Stage I and II, Peri-operative Chemotherapy

Intervention / Treatment
-----------------
* Drug: gemcitabine + cisplatine
* Drug: Paclitaxel + Carboplatine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically NSCLC stade I or II Resectable disease WHO performance status of 2 or less Exclusion Criteria: NSCLC stage III or IV

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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A: pre-operative chemotherapy<br>pre-operative chemotherapy (gemcitabine+cisplatine, 4 cycles) | Drug: gemcitabine + cisplatine<br>* gemcitabine 1250 mg/m², D1+D8 cisplatine 80 mg/m², D1 (D1=D22)<br>|
| Experimental: B: pre-operative chemotherapy<br>pre-operative chemotherapy (paclitaxel+carboplatin, 4 cycles) | Drug: gemcitabine + cisplatine<br>* gemcitabine 1250 mg/m², D1+D8 cisplatine 80 mg/m², D1 (D1=D22)<br>|
| Experimental: C: peri-operative chemotherapy<br>peri-operative chemotherapy (gemcitabine+cisplatine, 4 cycles) | Drug: Paclitaxel + Carboplatine<br>* paclitaxel 200 mg/m², D1 carboplatin AUC 6, D1 (D1=D22)<br>|
| Experimental: D: peri-operative chemotherapy<br>peri-operative chemotherapy (paclitaxel+carboplatin, 4 cycles) | Drug: Paclitaxel + Carboplatine<br>* paclitaxel 200 mg/m², D1 carboplatin AUC 6, D1 (D1=D22)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare 3-Years survival |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare Objective response rate |  | 6 weeks |
Non-Invasive Positive Pressure Ventilation Management of High Altitude Pulmonary Edema

Study Overview
=================
Brief Summary
-----------------
Trial of Non-Invasive Positive Pressure Ventilation Management of High Altitude Pulmonary Edema

Detailed Description
-----------------
Patients in the Everest area will assessed for evidence of acute HAPE. Subjects will be randomized and assigned to standard care options or treatment with Non-Invasive Positive Pressure Ventilation.

Official Title
-----------------
Non-Invasive Positive Pressure Ventilation Management of High Altitude Pulmonary Edema

Conditions
-----------------
High Altitude Pulmonary Edema, Non-Invasive Positive Pressure Ventilation, Hypoxia

Intervention / Treatment
-----------------
* Device: Non-Invasive Positive Pressure Ventilation
* Drug: Nifedipine
* Other: supplemental oxygen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adults (age 18-80) Travel through Pheriche, Nepal Diagnosis of HAPE by symptoms, vital signs, and lung ultrasound Exclusion Criteria: History of chronic respiratory conditions (asthma, COPD, ILD) Concomitant pneumonia or aspiration, cardiomyopathy, congestive heart failure Kidney disease Neurologic disorder Cognitive disorder Temporary altered mental status Use of phosphodiesterase inhibitors or nifedipine prior to diagnosis of HAPE Age under 18 or over 80 Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care Treatment<br>Continuous supplemental oxygen and nifedipine 30mg will be administered to patients. | Drug: Nifedipine<br>* Nifedipine 30mg, Pharmacotherapy<br>Other: supplemental oxygen<br>* supplemental oxygen<br>|
| Experimental: Non-Invasive Positive Pressure Ventilation Management<br>CPAP at 10mmHg with supplemental oxygen, as well as nifedipine 30mg will be administered to patients. | Device: Non-Invasive Positive Pressure Ventilation<br>* Continuous positive airway pressure delivered by face mask at 10cmH2O<br>* Other names: CPAP;Drug: Nifedipine<br>* Nifedipine 30mg, Pharmacotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen saturation | Displayed on pulse oximeter | Up to 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasonographic assessment of pulmonary edema | Quantification of B-lines | Up to 4 hours | 
| Subjective rating of dyspnea | Based on Dypnea Severity Scale (DSS) | Up to 4 hours |
The Influence of The Ear Popper on Serous Otitis Media and on the Accompanying Conductive Hearing Loss in Children

Study Overview
=================
Brief Summary
-----------------
This study is designed to check the effect of the use of the ear popper device on serous otitis media in children and on the conductive hearing loss accompanying the otitis. It is intended that 30 children aged 3-18 years will participate in the study. The inclusion criteria are : clinical serous otitis media for a duration of more then 3 months, a conductive hearing loss of at least 15 decibels air bone gap and tympanometry type B or C. The children will use the ear popper for 7 weeks. They will undergo otologic examination, audiometry and tympanometry at the beginning ao the trial, at 7 weeks and at 3 months from the beginning of the trial. The otologic findings and the audiometry and tympanometry results before and after the trial will be compared. We will try to determine whether the use of the ear popper in the test group will improve the conductive hearing loss and prevent the need for tympanostomy tube insertion.

Official Title
-----------------
The Influence of The Ear Popper on Serous Otitis Media and on the Accompanying Conductive Hearing Loss in Children

Conditions
-----------------
Otitis Media, Conductive Hearing Loss

Intervention / Treatment
-----------------
* Device: Ear Popper


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Serous Otitis Media for More Then 3 months Conductive Hearing Loss of More Then 15 decibels. Tympanometry type B or C. Exclusion Criteria: No History of Tympanostomy Tube Insertion or Adenoidectomy No Cranio or Facial Malformations No Acute Upper Respiratory Tract Infection or Acute Otitis Media

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Ear Popper|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Audiometry and tympanometry test results at at 7 weeks and 3 months from beginning of use of the ear popper. |  |  | 
| Otoscopic findings at at 7 weeks and 3 months from beginning of use of the ear popper. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hearing improvement at 7 weeks and 3 months from the beginning of the trial. |  |  | 
| Rate of referrals for tympanostomy tube insertion at 3 months |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ear, Effusion, Otitis, Media, Popper, Children