linjc16/ctgov huggingface dataset:
Intraoperative EABR for Decision Making

Study Overview
=================
Brief Summary
-----------------
In this study patients undergoing simultaneous translabyrinthine vestibular schwannoma resection and cochlear implantation are included. The goal of the study is to correlate the eABR results with postoperative hearing results.

Detailed Description
-----------------
Patients undergoing translabyrinthine vestibular schwannoma resection are included in the study. Preoperatively an eABR is carried out, as well as before and after tumor resection. Postoperatively patients are fitted with a cochlear implant as routinely carried out. The postoperative hearing results with cochlear implant are correlated to the eABR results. The study is an observational study since eABR measurements are not part of the study. A correlation between eABR results categorized in three groups (good response, weak response, no response) with monosyllable understanding with cochlear implant (measured with Freiburger monosyllables test).

Official Title
-----------------
Simultaneous Translabyrinthine Surgery of Vestibular Schwannoma and Cochlear Implantation With Intraoperative eBERA and Correlation to Hearing Results - a Pilot Study

Conditions
-----------------
Vestibular Schwannoma, Hearing Loss

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients between 18 and 99 years undergoing translabyrinthine vestibular schwannoma resection Patients wanted hearing rehabilitation with a cochlear implant Exclusion Criteria: patients who do not want to be part of the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of eABR results to postoperative hearing results | eABR is correlated with postoperative hearing results eABR will be divided in three categories - good response, weak response, no response. Hearing results will be measured with speech understanding in Freiburg monosyllables word test which is measured in % of monosyllables understanding at 65 and 80dB | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
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Cochlear implant
The Newborn Project: Examining the Oxygenation of Brain Tissue During General Anesthesia

Study Overview
=================
Brief Summary
-----------------
This study will be an observational, prospective trial that will measure the cerebral oxygenation of infants scheduled to undergo general anesthesia at Boston Children's Hospital.

Detailed Description
-----------------
Data will be collected from the Near Infrared Spectroscopy (NIRS) monitor and the patient's medical record. When the NIRS sensor is attached to the patient's forehead the oxygenation of brain tissue will be continuously monitored. All other information will be routinely recorded as standard clinical care and this information will be obtained from the patient's medical record. The NIRS monitor data will by time synched to the anesthesia record and downloaded to a secured password protected file. In the post-operative period, patient data will be collected including: 1) any skin findings related to the placement of the NIRS or pulse oximetry probes 2) any unanticipated need for hemodynamic support, 3) laboratory values including hemoglobin levels, electrolytes, and blood gases, 4) new neurological findings (seizures etc.)

Official Title
-----------------
The Newborn Project: A Prospective Observational Study Examining the Oxygenation of Brain Tissue During General Anesthesia Using Near Infrared Spectroscopy Technology

Conditions
-----------------
Blood Pressure

Intervention / Treatment
-----------------
* Device: NIRS Monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children less than 6 months of age Undergoing a scheduled or emergent procedure with anesthesia at Boston Children's Hospital Exclusion Criteria: Placement of NIRS sensor that will interfere with surgery Child has an allergy to medical grade adhesives or pre-existing skin irritation at the sensor site Scheduled for a cardiac procedure Patient's care team or patient's family declines participation American Society of Anesthesiologists (ASA) criteria of IV or greater Infants who are being treated with sympathomimetic medications intraoperatively

Ages Eligible for Study
-----------------
Maximum Age: 6 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NIRS Monitoring<br>A NIRS sensor will be placed on the forehead of the patient upon entry to the operating room and will remain on, as tolerated, for the duration of surgery | Device: NIRS Monitoring<br>* NIRS data will be collected throughout the surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral Oxygenation | Determine what factors are correlated with changes in the cerebral oxygenation | Intraoperative period |
A Twelve-Week Study of Varenicline for Safety and Efficacy in Comparison With Placebo and Zyban for Smoking Cessation

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to evaluate the safety and efficacy of varenicline given for a twelve week treatment period in comparison with placebo and Zyban for smoking cessation.

Official Title
-----------------
A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study With Follow-up Evaluating the Safety and Efficacy of Varenicline Tartrate ( CP-526,555) in Comparison to Zyban for Smoking Cessation

Conditions
-----------------
Smoking Cessation

Intervention / Treatment
-----------------
* Drug: varenicline (CP-526,555)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must have smoked an average of at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year. Exclusion Criteria: Subjects who have used bupropion (Zyban or Wellbutrin) previously.

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: varenicline (CP-526,555)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 4 week Continuous Quit Rate ( 4 week CQR ) for Weeks 9 -12. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuous abstinence Weeks 9-52 |  |  | 
| Long-term Quit Rate Week 52 |  |  | 
| Continuous abstinence Weeks 9 -24 |  |  | 
| 7-day Point Prevalence Abstinence Weeks 12, 24, and 52 |  |  | 
| 4-week Point Prevalence Abstinence at Week 52 |  |  | 
| Minnesota Nicotine Withdrawal Scale |  |  | 
| Brief Questionnaire of Smoking Urges |  |  | 
| Smoking Effects Inventory |  |  | 
| Change from baseline in bodyweight |  |  |
Development and Validation of the Saint Paul's Endoscopy Comfort Scale (SPECS) for Colonoscopy and Upper Endoscopy

Study Overview
=================
Brief Summary
-----------------
The investigators created the St. Paul's Endoscopy Comfort Score (SPECS) which includes the frequency of verbal cues, body positioning and anxiety levels with descriptions for each of the variables. Our objective is to compare the SPECS, NAPCOMs, NPAT and GS amongst different observers and to determine any correlation with patient satisfaction.

Detailed Description
-----------------
Colonoscopy is used for the diagnosis and treatment of colonic lesions as well as screening and follow up of patients at risk of developing colorectal cancer. With the increasing demand for colonoscopies, the number of procedures performed in recent years has increased dramatically (Bjorkman & Popp Jr., 2006). Given that performance of a high quality colonoscopy is dependent on the expertise and technical skills of the endoscopist, quantitative and reliable methods for measurement of the quality of colonoscopy are needed. Although other colonoscopy quality indicators, such as adenoma detection rate, have been studied comprehensively (Rex, et al., 2006), patient comfort as a measure of endoscopic quality performance has not been thoroughly assessed.

Official Title
-----------------
Do You Have Your SPECS in Order? Development and Validation of the Saint Paul's Endoscopy Comfort Scale (SPECS) for Colonoscopy and Upper Endoscopy

Conditions
-----------------
Patient Comfort

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 19 years or older Outpatients referred to Saint Paul's Hospital for colonoscopy and upper endoscopy Capable of reading and understanding English Exclusion Criteria: Patients who undergo colonoscopy and upper endoscopy in the same appointment

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inter-observer reliability | To determine the inter-observer reliability for the SPECS amongst observers and the different comfort scores, NAPCOMS, GS and NPAT. | 15-30 minutes | 
| Correlation with patient's reported pain | To determine the correlation of SPECS, NAPCOMS, GS and NPAT with post-procedure patient reported pain and satisfaction controlling for sedation. | 10-15 minutes |
Imaging of in Vivo Sigma-2 Receptor Expression With 18F-ISO-1 Positron Emission Tomography in Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Pilot study using [18F]ISO-1 PET/CT to image sigma-2 receptor binding in metastatic breast cancer. Correlate baseline uptake and change in uptake after therapy with time to progression and standard and experimental pathology assays of biopsy or surgical tissue. The target population is up to 30 adult patients at least 18 years, with at least one site of disease outside the liver by at least one type of standard imaging.

Official Title
-----------------
Imaging of in Vivo Sigma-2 Receptor Expression With 18F-ISO-1 Positron Emission Tomography in Metastatic Breast Cancer

Conditions
-----------------
METASTATIC BREAST CANCER

Intervention / Treatment
-----------------
* Device: Positron emission tomography (PET/CT) imaging
* Device: radiotracer [18F]ISO-1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age Biopsy proven or clinically documented metastatic breast cancer with at least one lesion outside the liver by standard imaging (e.g. CT, MRI, Bone Scan, Ultrasound, FDG PET/CT) Plan to start new systemic therapy for metastatic disease. Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures. Exclusion Criteria: Females who are pregnant at the time of screening will not be eligible for this study, urine or serum pregnancy test will be performed in women of child-bearing potential at the time of screening. Inability to tolerate imaging procedure in the opinion of an investigator or treating physician. Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Positron emission tomography (PET/CT) imaging|nan|
|Device: radiotracer [18F]ISO-1|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | 3 years |
Survival Study for Participants Treated With Ipilimumab-Nivolumab Combination Therapy

Study Overview
=================
Brief Summary
-----------------
This study will review published trial literature and documents for Overall Survival (OS) to evaluate the association between the hazard of death and each baseline variable.

Official Title
-----------------
Projecting Survival for Patients Treated With First-Line Ipilimumab-Nivolumab Combination Therapy Using a Prognostic Model and Cost Per Responder Model of Ipilimumab-Nivolumab Combination Therapy

Conditions
-----------------
Melanoma

Intervention / Treatment
-----------------
* Other: Non-Interventional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of melanoma Exclusion Criteria: Age less than 18 years old

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| First-Line Ipilimumab<br>patients who received ipilimumab as their first-line treatment | Other: Non-Interventional<br>* Non-Interventional<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prognostic Model of Overall Survival (OS) | The OS prognostic model uses Individual patient data from a pooled analysis of 12 ipilimumab studies. | 10 years |
INHALATION CHAMBER MANAGEMENT IN PEDIATRICS: EFFICACY OF AN EDUCATIONAL INTERVENTION IN PATIENTS DIAGNOSED WITH BRONCHOSPASM AND THEIR FAMILY CAREGIVERS.

Study Overview
=================
Brief Summary
-----------------
Several studies show that unnecessary and frequent visits to the emergency department for bronchospasm care are associated with inadequate management of inhalers and poor education on the approach to respiratory distress. Main objective: To determine the degree of frequentation to the pediatric emergency department for bronchospasm at 1, 3 and 6 months after the educational intervention. Design: Randomized controlled clinical trial with two groups: EXPERIMENTAL will receive the educational intervention, along with usual care, and CONTROL will receive usual care. Subjects: pediatric patients (2-15 years) diagnosed with bronchospasm; in home treatment with inhalation chambers; and their parents. Emergency Department recruitment. Follow-up at home

Official Title
-----------------
INHALATION CHAMBER MANAGEMENT IN PEDIATRICS: EFFICACY OF AN EDUCATIONAL INTERVENTION IN PATIENTS DIAGNOSED WITH BRONCHOSPASM AND THEIR FAMILY CAREGIVERS.

Conditions
-----------------
Bronchospasm

Intervention / Treatment
-----------------
* Behavioral: educational intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients between 2-15 years of age attending the Pediatric Emergency Department of the Hospital Universitario Puerta de Hierro Majadahonda (HUPHM) with a mild, moderate or severe bronchospasm crisis and who have used the inhalation chambers on at least one occasion; with autonomy in the use of the inhalation chambers at home Exclusion Criteria: Not understanding Spanish

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 15 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: CONTROL<br>receive usual care | |
| Experimental: EXPERIMENTAL<br>receive the educational intervention, along with usual care | Behavioral: educational intervention<br>* will also have an extra educational intervention, a group intervention (4-6 people) through a one-hour training session via zoom, which will be given by the PI (extensive experience in the subject) a week after discharge from the ER. Information will be reinforced and doubts will be solved<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| degree of frequentation to the emergency department |  | 6 months |
Comparison Study of Two Splints Used for Treatment of Acute Temporomandibular Pain.

Study Overview
=================
Brief Summary
-----------------
The most commonly applied treatment against acute temporomandibular signs and symptoms is pharmacotherapy. The evidence on treatment efficacy of non-medication treatments (like splints) is very low. Two very commonly used splints are the Aqualizer® and the soft polyester splint. These are splints applied for a short period of time, until the treatment with a hard splint and/or physiotherapy begins. Aim of this study is to compare the clinical short-time efficacy of these two splints for the treatment of acute temporomandibular pain and compare it to a control group receiving no therapy for that short time. The study hypothesis is that there is a difference in pain reduction between the three groups of patients (two intervention and one control group).

Official Title
-----------------
Pilot Clinical Trial on the Treatment Effectiveness of Two Splints for Acute Temporomandibular Pain.

Conditions
-----------------
Myofascial Pain

Intervention / Treatment
-----------------
* Device: Aqualizer
* Device: Soft splint


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, non-chronic orofacial pain Exclusion Criteria: Pregnancy, chronic orofacial pain, dental treatment need, dental pain, edentulous space larger than 5mm, more than three molars missing in the same quadrant, rheumatic disease, Injury/operation in maxillofacial area.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aqualizer<br> | Device: Aqualizer<br>* The Aqualizer is a soft splint with water-filled pads.<br>|
| Active Comparator: Soft splint<br>elastic splint made of copolyester foil | Device: Soft splint<br> <br> |
| No Intervention: Counselling<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain |  | 2-3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mouth opening |  | 2-3 weeks |
Fetal Front-abdominal Wall Thickness and Perinatal Outcome

Study Overview
=================
Brief Summary
-----------------
Abnormal fetal development such as macrosomia can cause some complications on both fetus and mother.The measurement of fetal anterior abdominal wall thickness (FAWT) is an easy examination that it can be obtained during an examination of a pregnant woman by ultrasound. Macrosomia for fetus can lead to some morbidities. It can affect perinatal outcome and increase childbirth complications and operative birth. There are some studies scrutinizing the relationship between FAWT and diabetes in the literature. However there are few studies which scrutinize effect of FAWT on both abnormal fetal development and adverse perinatal outcomes in non-diabetic pregnancies and non high risk pregnancies. Hence the investigators wonder if FAWT can anticipate birth-weight or macrosomic infant or perinatal outcome regarding with macrosomia in the second trimester.

Official Title
-----------------
Effect of Fetal Front-abdominal Wall Thickness on Birth Weight and Perinatal Outcome at 24-26. Gestational Weeks

Conditions
-----------------
Fetal Macrosomia, Abdominal Wall Mass, Perinatal Problems

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A total of 96 women with low risk pregnancy coming to our clinic for a routine antenatal examination in 26-28th gestational weeks were included to this study and performed 75 gr- oral glucose tolerance test (OGTT). Exclusion Criteria: The participants with a positive 75-g OGTT were excluded. Additionally those following criteria were accepted as the exclusion criteria of this study: hypertension, preeclampsia, diabetes, fetal distress, fetal anomaly, multiple pregnancy, preterm labor, preterm premature rupture of membrane, placenta previa, polyhydramnios and intrauterine fetal growth restriction.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| the study group<br>A total of 96 women with low risk pregnancy coming to the clinic for a routine antenatal examination in 26-28th gestational weeks were included to this study | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relationship between fetal abdominal wall thickness and macrosomia |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fetal macrosomia, fetal abdominal wall thickness, subcutaneous adipose tissue