linjc16/ctgov huggingface dataset:
The Effect of Intravenous Nalbuphine on PONV With Intrathecal Morphine in Abdominoplasty.

Study Overview
=================
Brief Summary
-----------------
How effectively intravenous nalbuphine can reduce the incidence of PONV after intrathecal administration of morphine in abdominoplastic surgery.

Official Title
-----------------
The Effect of Intravenous Nalbuphine on Postoperative Nausea and Vomiting With Intrathecal Morphine in Abdominoplastic Surgery.

Conditions
-----------------
Abdominal Obesity

Intervention / Treatment
-----------------
* Drug: Intrathecal Morphine
* Drug: Intrathecal Morphine + Intravenous Nalbuphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing abdominoplasty under spinal anesthesia American Society of Anesthesiologists (ASA) class I and II. Exclusion Criteria: allergy to local anesthetics bleeding diatheses local infection or sepsis

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo group<br> | Drug: Intrathecal Morphine<br>* Group 1<br>|
| Active Comparator: Nalbuphine group<br> | Drug: Intrathecal Morphine + Intravenous Nalbuphine<br>* Group 2<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative nausea and vomiting | A verbal descriptive scale (VDS) was used to assess the severity of PONV. ( no nausea=0, severe nausea= 10) by postoperative nausea and vomiting scale which range (o no nasuea to 10 sever vomating). A verbal descriptive scale (VDS) was used to assess the severity of PONV . | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain and puririts. | Visual analogue scale (VAS) pain scores (no pain = 0, worst possible pain = 10). | 24 hours |
Time to Hip Fracture Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate how time from hospital admission to start of surgery influence mortality in patients with acute hip fracture. Data on patients with hip fracture surgery will be collected from the hospital's registration system and will be analyzed regarding age, gender, American Society of Anesthesiologists (ASA) Physical Status Classification, type of surgery and time from admission to surgery along with data on mortality.

Official Title
-----------------
Preoperative Waiting Time to Surgery Related to Mortality in Hip Fracture Patients

Conditions
-----------------
Hip Fractures, Mortality, Surgery

Intervention / Treatment
-----------------
* Procedure: Waiting time for hip fracture surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: undergoing hip fracture surgery between 2007-2016. Over 60 years of age. Exclusion Criteria: Pathological fracture. In-hospital falls. Diagnostic delay.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 105 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Waiting time for hip fracture surgery|Time from hospital admission to start of hip fracture surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Date of Death captured through Swedish Taxation Authority within 30 days | 30 days |
Phase I Study to Evaluate the Tolerability of Eye Drop DA-6034 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This is a double-blind, randomized, placebo-controlled, 4-period, cross-over clinical trial. The study is designed to evaluate the safety and local tolerability of DA-6034 upon single and repeated-dose topical application to the both eyes in healthy volunteers.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Local Tolerability After Administration of Eye Drop DA-6034 in Healthy Volunteers(Phase I)

Conditions
-----------------
Dry Eye Syndrome

Intervention / Treatment
-----------------
* Drug: DA-6034
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20-50 year-old healthy subjects Exclusion Criteria: Presence or history of dry eye or other ocular or systemic diseases Corrected visual acuity less than 20/40 in either eye at the screening Any eye surgery or laser eye surgery within the past six months Intraocular pressure greater than 22 mmHg in either eye at the screening Break-up time less than 10 sec with OSDI score corresponding to mild to severe dry eye symptoms in either eye at the screening Unanesthetized Schirmer scores <10 mm in either eye at the screening

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DA-6034<br> | Drug: DA-6034<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular symptomatology, ophthalmologic tests |  | Single dose: up to 5 days, Multiple dose: up to 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events, vital signs, physical examinations, ECG findings, clinical laboratory tests, ocular symptomatology, ophthalmologic tests, Unanesthetized Schirmer tests |  | Single dose: up to 10 days, Multiple dose: up to 20 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Eye drop, Dry eye
To Evaluate the Efficacy and Safety in Subjects With Functional Dyspepsia

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy and safety of Z-338 in subjects with Functional Dyspepsia

Conditions
-----------------
Functional Dyspepsia

Intervention / Treatment
-----------------
* Drug: Z-338


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects presenting diagnosis of FD as defined by the Rome II Subjects presenting postprandial fullness and/or Early satiety should be the most bothersome symptom Exclusion Criteria: -

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

| Intervention/Treatment |
| --- |
|Drug: Z-338|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global subject Outcome Assessment |  | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Individual symptom |  | 12 month |
Compare the Pharmacokinetics of NVP-1805 and Coadministration of NVP-1805-R1 With NVP-1805-R2

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the pharmacokinetics of NVP-1805 and coadministration of NVP-1805-R1 with NVP-1805-R2.

Detailed Description
-----------------
pharmacokinetics and safety of NVP-1805 compared to coadministration of NVP-1805-R1 with NVP-1805-R2

Official Title
-----------------
A Clinical Trial to Compare the Pharmacokinetics and Safety of NVP-1805 and Coadministration of NVP-1805-R1 With NVP-1805-R2 in Healthy Male Volunteers

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

Intervention / Treatment
-----------------
* Drug: NVP-1805
* Drug: NVP-1805-R1and NVP-1805-R2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult subjects who signed informed consent BMI of >18.0 kg/㎡ and <30.0 kg/㎡ subject, weight more than 50kg(45 kg or more for woman) Exclusion Criteria: Subjects participated in another clinical trial within 6 months prior to administration of the study drug Inadequate subject for the clinical trial by the investigator's decision Subjects participated in another clinical trial within 6 months prior to administration of the study drug

Ages Eligible for Study
-----------------
Minimum Age: 19 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: NVP-1805<br>NVP-1805 | Drug: NVP-1805<br>* orally, once daily on Period 1 and Period 3 (or Period 2 and Period 4)<br>|
| Active Comparator: NVP-1805-R1 and NVP-1805-R2<br>coadministration of NVP-1805-R1 and NVP-1805-R2 | Drug: NVP-1805-R1and NVP-1805-R2<br>* orally, once daily on Period 1 or Period 3 (or Period 2 and Period 4)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of plasma: AUClast |  | 0hours - 72hours | 
| Pharmacokinetics of plasma: Cmax |  | 0hours - 72hours |
Sleep and Activity Monitoring After Thoracic Surgery

Study Overview
=================
Brief Summary
-----------------
Show by collecting sleep and activity data, outcomes after thoracic surgery are improved with better sleep and increased activity.

Detailed Description
-----------------
Little is known about how sleep deprivation affects recovery after thoracic surgery. There is some evidence that in cardiac surgery, sleep disturbance can lead to delayed recovery and mental status changes in the postoperative period. There are no similar reports of studies after thoracic surgery. We think that increased activity after surgery is beneficial for a rapid recovery and prevents blood clots, pneumonia and deconditioning. Without specific data this is difficult to prove.

Official Title
-----------------
Sleep and Activity Monitoring After Thoracic Surgery

Conditions
-----------------
Thoracic Surgery, Surgery, Thoracic

Intervention / Treatment
-----------------
* Other: Fitbit


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: undergoing thoracic surgery at Mayo Clinic Rochester expected to stay in hospital for at least 4 days signed consent form Exclusion Criteria: Unable to provide 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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Fitbit|A FitBit HR monitor will be placed on patients when they arrive on the nursing unit after thoracic surgery. Sleep and activity will be monitored for the duration of the patient's hospitalization and the data from the Fitbit HR device will be downloaded by the study staff to a computer.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Stay |  | Until discharge, an average of 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of pneumonia while hospitalized |  | Until discharge, an average of 5 days | 
| Incidence of blood clot while hospitalized |  | Until discharge, an average of 5 days | 
| Incidence of deconditioning while hospitalized |  | Until discharge, an average of 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sleep, exercise, activity
Preliminary Assessment of Added Diagnostic Value of Dual Energy CT Images Using Data Acquired on a Spectral Detector CT

Study Overview
=================
Brief Summary
-----------------
Study hypothesis: Post-processed SDCT images provide additional diagnostic value over conventional CT datasets. The CT examination would be a clinically-necessary, standard-of-care CT performed as per the clinical indication. The protocol and scan parameters for the CT exam will be similar to that of an equivalent scan performed with any other CT scanner. There would be no additional scanner of injection of any drug specifically for the study. The conventional CT images generated by the scanner will be used for clinical purposes as routinely practiced.

Official Title
-----------------
Preliminary Assessment of the Added Diagnostic Value of Dual Energy Computed Tomography (DECT) Images Using Data Acquired on a Spectral Detector Computed Tomography (SDCT)

Conditions
-----------------
Compare Image Quality Between SDCT and Conventional CT Images of Any Tissue Lesion, Determine Optimal Monochromatic Energy Level for a Coronary Artery Image

Intervention / Treatment
-----------------
* Device: Computed Tomography scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a patient scheduled for a clinically indicated CT scan for one or more of the following body regions/organ systems: head and neck body (chest and abdomen/pelvis) cardiovascular structures. these scans may be without contrast, with contrast enhancement, or CT angiograms. Exclusion Criteria: under the age of 18 years old standard exclusion criteria for CT scans

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Computed Tomography scan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine if Post-processed SDCT images provide additional diagnostic value over conventional CT datasets. | Data will be recorded as mean +/- standard deviation for each parameter. Student's t test and Wilcoxon's test will be performed to compare objective and subjective data respectively. In addition, differences on lesion detection and characterization, sensitivity, specificity and accuracy of conventional CT and SDCT images will be compared using a receiver operating curve (ROC) analysis. Additionally, agreement between both readers will be evaluated using Cohen´s kappa test (poor agreement for κ ≤ 0.19; fair agreement for κ = 0.2-0.39; moderate agreement for κ = 0.4-0.59, substantial agreement for κ = 0.6-0.79 and very good agreement for κ = 0.8-1.00; 19). A P value of <0.05 will be required for statistical significant difference. | 6 months |
Studying Biomarkers in Samples From Younger Patients With Kidney Cancer

Study Overview
=================
Brief Summary
-----------------
This laboratory study is looking into biomarkers in samples from younger patients with kidney cancer. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors find better ways to treat cancer.

Detailed Description
-----------------
PRIMARY OBJECTIVES: I. To determine whether focal adhesion kinase (FAK) is expressed and if FAK is phosphorylated in pediatric renal tumors. OUTLINE: Archived tumor tissue samples are analyzed for FAK expression by immunohistochemistry (IHC). IHC staining is compared in normal renal tissue, Wilms tumor (routine and anaplastic), malignant rhabdoid tumor of the kidney, clear cell sarcoma of the kidney, and mesoblastic nephroma.

Official Title
-----------------
Focal Adhesion Kinase Expression in Pediatric Renal Tumors

Conditions
-----------------
Childhood Kidney Neoplasm, Clear Cell Renal Cell Carcinoma, Congenital Mesoblastic Nephroma, Rhabdoid Tumor of the Kidney

Intervention / Treatment
-----------------
* Other: Laboratory Biomarker Analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Formalin-fixed, paraffin-embedded tissue samples from patients diagnosed with the following renal tumors: Anaplastic Wilms tumor Malignant rhabdoid tumor of the kidney Clear cell sarcoma of the kidney Mesoblastic nephroma
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Basic science (FAK expression)<br>Archived tumor tissue samples are analyzed for FAK expression by IHC. IHC staining is compared in normal renal tissue, Wilms tumor (routine and anaplastic), malignant rhabdoid tumor of the kidney, clear cell sarcoma of the kidney, and mesoblastic nephroma. | Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FAK expression in pediatric renal tumors |  | Baseline |
Use of MgSO4 for Pain After Bariatric Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to investigate the effect of magnesium sulfate on pain management for pain after sleeve gastrectomy operation

Detailed Description
-----------------
The purpose of this study is to investigate the effect of magnesium sulfate on pain management for pain after sleeve gastrectomy operation. Design: A prospective, randomized, controlled clinical study. Setting: University hospital. Participants: Eighty patients undergoing sleeve gastrectomy. Measurements and Main Results: Visual analog scale for pain score, sedation score, mean arterial pressure, heart rate, and valid and invalid analgesic demand will record. Serum magnesium levels will determined at preoperative evaluation, postanesthesia care unit admission and at 24 hours. Side effects will also record.

Official Title
-----------------
Use of MgSO4 Reduced Opioid Consumption for Pain After Sleeve Gastrectomy Operations: A Prospective Randomized Clinical Trial

Conditions
-----------------
Therapeutic Opioid Induced Constipation (Disorder)

Intervention / Treatment
-----------------
* Drug: Magnesium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 65 year old individuals who underwent laparoscopic sleeve gastrectomy. Exclusion Criteria: One or more of the following: cardio - vascular and respiratory diseases, drug and/or alcohol abuse, use of daily an algesia 24 hours before the surgery, renal failure, and liver dysfunction.

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

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The patients undergoing sleeve gastrectomy.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group MgSO4<br>The magnesium group (group Mg, n _ 40) received an additional infusion of MgSO4 (30 mg/kg by bolus and 10 mg/kg/h by infusion for 24 hours) | Drug: Magnesium<br>* The magnesium group (group Mg, n _ 40) received an additional infusion of MgSO4<br>|
| No Intervention: Group Control<br>the control group (group C, n _ 40) received the same amount of IV saline | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Item pain intensity measure assessed by using VAS scores | Pain was assessed by using VAS scores (0: no pain and 10: worst pain) imaginable recorded at 0, 1, 2, 4, 6, 24, and 24 hours. | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sleeve gastrectomy, magnesium sulfate, postoperative pain, bariatric surgery
Long-term Effectiveness of Contour Augmentation in Sites With Early Implant Placement

Study Overview
=================
Brief Summary
-----------------
In this prospective case series study, 20 patients with an implant-borne single crown following early implant placement with simultaneous contour augmentation will be followed for 10 years. Clinical, radiologic, and esthetic parameters will be assessed. In addition, cone beam computed tomography (CBCT) will be used at 10 years to examine the facial bone wall and compared to the 6 year data.

Official Title
-----------------
Long-term Effectiveness of Contour Augmentation in Sites With Early Implant Placement

Conditions
-----------------
Jaw, Edentulous, Partially, Dental Implants, Single-tooth, Grafting Bone

Intervention / Treatment
-----------------
* Procedure: Contour augmentation with implant placement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Single tooth gaps post extraction in the esthetic zone Written informed consent Exclusion Criteria: Heavy smoking (more than 10 cigarettes per day)

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Contour augmentation<br> | Procedure: Contour augmentation with implant placement<br>* Contour augmentation with implant placement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of contour augmentation | Measurement of facial bone wall width with cone beam CTs (in mm) | 10 year examination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Esthetic examination | Pink Esthetic Score | 10 year examination | 
| Peri-Implant soft tissue health | Plaque Index | 10 year examination | 
| Peri-implant bone loss over time | Distance from the implant-shoulder to the first bone-to-implant-contact (DIB) in mm | 10 year examination | 
| Peri-Implant soft tissue health | Sulcus Bleeding Index | 10 year examination |