linjc16/ctgov huggingface dataset:
Respiratory Effects of Perioperative Oxygen During General Anaesthesia

Study Overview
=================
Brief Summary
-----------------
Aim: To investigate the effect of high intra- and postoperative oxygen concentration (80%, as opposed to normally 30%) on pulmonary gas exchange and other pulmonary complications after abdominal surgery. Background: Previous studies have shown possible beneficial effects of high perioperative oxygen concentration on surgical wound infection and healing, but all pulmonary effects are not clarified. Change in perioperative PaO2/FiO2 and shunt-fraction, measured by a gas rebreathing technique, can describe pulmonary oxygenation. This could add knowledge to the pulmonary effects of high vs. normal oxygen concentration. Primary hypothesis of study: Perioperative use of a 80% oxygen concentration reduces the PaO2/FiO2-index compared to 30% oxygen.

Official Title
-----------------
Perioperative Oxygen Fraction - Effects on the PaO2/FiO2-Index During Laparotomy

Conditions
-----------------
Laparotomy

Intervention / Treatment
-----------------
* Drug: Oxygen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older Laparatomy, elective Exclusion Criteria: Inability to give informed consent Chemotherapy within 3 months Other surgery within 30 days(except surgery in local anaesthesia) Inability to keep oxygen saturation above 90% without supplemental oxygen (measured preoperatively by pulse oximetry)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Group 1 is given 30% oxygen during and 2 hours after surgery | Drug: Oxygen<br>* Inspiratory fraction during anaesthesia<br>|
| Active Comparator: 2<br>Group 2 is given 80% during and 2 hours after surgery. | Drug: Oxygen<br>* Inspiratory fraction during anaesthesia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PaO2/FiO2-index during general anaesthesia. |  | End of surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PaO2/FiO2-index during general anaesthesia and postoperative recovery. |  | 1½ hour after surgery. | 
| Atelectasis and Pneumonia |  | 14 days after surgery | 
| Arterial oxygen saturation |  | 2 hours and 3 days after surgery. | 
| Change in functional residual capacity (FRC) |  | 2 hours after surgery. | 
| Change in effective pulmonary bloodflow |  | 2 hours after surgery. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
perioperative oxygen, respiratory complications
Neuro 1 vs. Neuro 2 Sound Processors

Study Overview
=================
Brief Summary
-----------------
This study evaluates the benefit of Neuro 1 sound processor upgrade in speech perfomance in adults. Half of participants will be tested with Neuro 1 first and Neuro 2, while the other half will be tested with Neuro 2 first and then Neuro 1.

Detailed Description
-----------------
The Neuro 1 processor represented a technological advancement over past models, particularly in detecting the environment and automatically adjusting to the sound environment. A second version of the Neuro 1 processor has been developed, the Neuro 2. The signal processing and stimulation characteristics are similar, so speech comprehension levels are expected to be equivalent. This study is designed to compare Neuro 1 and Neuro 2 in terms of audiometric performance.

Official Title
-----------------
Comparison of Audiometric Performance Between the Neuro 1 and Neuro 2 Sound Processors.

Conditions
-----------------
Hearing Loss, Sensorineural, Cochlear Hearing Loss

Intervention / Treatment
-----------------
* Device: Neuro 1 & Neuro 2
* Device: Neuro 2 & Neuro 1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: written informed consent primary implantation subject having participated to previous Neuro 1 sound processor study in Canada fluent in English, including reading and writing. Exclusion Criteria: psychologically unsuitable unrealistic expectations regarding possible benefits, risks, and limitations that are inherent to the device non compliant with all investigational requirements.

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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neuro 2 Upgrade<br>Participant wears Neuro 1 sound processor and is tested, then is upgraded with the new sound processor Neuro 2 and tested. | Device: Neuro 1 & Neuro 2<br>* participant common fitting map used for tests<br>|
| Experimental: Neuro 1 Downgrade<br>Participant wears Neuro 2 sound processor and is tested, then is downgraded with the sound processor Neuro 1 and tested. | Device: Neuro 2 & Neuro 1<br>* participant common fitting map used for tests<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| speech recognition in quiet | Hearing In Noise Test | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| speech recognition in noise | Hearing In Noise Test | Day 1 | 
| pure tone threshold | from 250Hz to 8kHz | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
upgrade, cochlear implant, sound processor
Executive Dysfunction & Suicide: An Exploration Of Risk Factors In Traumatically Brain Injured Veterans

Study Overview
=================
Brief Summary
-----------------
This is a study to learn more about traumatic brain injury (TBI) and suicidal behaviors. The purpose of this research is to find out more about the issues related to these conditions. This study seeks to explore the relationship between executive dysfunction and suicidal behavior in an outpatient population.

Official Title
-----------------
Executive Dysfunction & Suicide: An Exploration Of Risk Factors In Traumatically Brain Injured Veterans

Conditions
-----------------
Traumatic Brain Injury (TBI), Suicidal Behavior

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of traumatic brain injury, history of suicidal behavior. Age 18-74. Currently receiving care through the Eastern Colorado Health Care System (ECHCS) Denver VA TBI Interdisciplinary Team. Exclusion Criteria: History of other significant neurological disease. Diagnosis of Schizophrenia. Test of Memory Malingering (TOMM) performance lower than 50%. Behavior which could be described as Substance Abuse in the 7 days prior to participation. Current guardianship or mention of recommendation for guardianship in medical chart within the past six months. Inability to read the informed consent document. Inability to adequately respond to questions regarding the informed consent procedure. Significant hearing impairment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 74 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 |
| --- | --- |
| TBI and Suicidal Behavior<br> | |
| TBI and No Suicidal Behavior<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
To Evaluate The Anrogens and Ovary Function in In Vitro Fertilization

Study Overview
=================
Brief Summary
-----------------
Because the society convention is changed, people are late for getting married, leading to increasing the bearing age in women. According to the previous study, if the age is over 30, the oocyte number in ovary has left only 10％ and 3％ in over 40 years old. The data is collected by Bureau of Health Promotion, Department of Health shows that there are about 7000 people treating the infertility and it spends about 150000 to 250000 NT dollars in every in vitro fertilization (IVF) cycle, but the live birth rate is only 30％. So it is important to know how to estimate and approve the ovary function that lead to increase the live birth rate. The investigators plan to estimate the correlation between the serum androgens levels and pregnancy outcome in the women who have infertility problem. Furthermore, for the repeated IVF cycle, the ovary function might be re-evlauated because of the possible effect from stimulated drugs used on previous cycle. It's important to understand the ovary function for IVF patient to choose the appropriate drugs and dose. The investigators use blood and clinical test to analyze, the items for analysis are below: Routine blood test: FSH、LH、E2、P4、Anti-Mullerian Hormone(AMH)、 Studied blood test: Inhibin B、total testosterone (TT)、Androstenedione、DHEA-S Clinical test: Ultrasound Personal condition. In order to finishing the test, every patient will be asked to collect about 10 to 15 cc blood for the research.

Official Title
-----------------
To Evaluate The Androgens and Ovary Function Impact on The Pregnancy Outcome in In Vitro Fertilization

Conditions
-----------------
In Vitro Fertilization

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: This study include the patients who are evaluated by the doctors and are sure to process the IVF cycle. Exclusion Criteria: This study exclude the patients who are not evaluated by the doctors and are not sure to process the IVF cycle.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| male/female, immunity or others factor infertility, IVF<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
In Vitro Fertilization (IVF), androgens, ovary function, This study include the patients who are evaluated by the doctors and are sure to process the In Vitro Fertilization cycle.
The IBEP Study: an Intervention for Lifestyle Modification in Women With Gestational Diabetes

Study Overview
=================
Brief Summary
-----------------
The IBEP study is a randomized control trial of a healthy lifestyle intervention program for women with gestational diabetes. The primary aim of the study is to evaluate whether women with gestational diabetes enrolled in an intensive behavioral educational program (IBEP) demonstrate lower mean fasting glucose levels measured by 2 hour 75 gram oral glucose tolerance test (OGTT) at 6 weeks postpartum compared to women with gestational diabetes who undergo routine gestational diabetes education and counseling.

Official Title
-----------------
The IBEP Study: a Randomized Control Trial of an Educational Intervention for Lifestyle Modification in Women With Gestational Diabetes.

Conditions
-----------------
Gestational Diabetes, Weight Gain During Pregnancy, Weight Loss After Pregnancy

Intervention / Treatment
-----------------
* Behavioral: Intensive Behavioral Modification


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women diagnosed with gestational diabetes between 20 and 34 weeks gestation Exclusion Criteria: women on chronic steroid therapy women with a diagnosis of GDM <20 weeks or >34 weeks

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intensive Behavioral Modification<br>intensive dietary counseling, increased activity, lactation consult | Behavioral: Intensive Behavioral Modification<br>* Intensive dietary counseling, increased physical activity, lactation counseling<br>|
| No Intervention: Routine care<br>standard dietary counseling | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The IBEP Study | To evaluate mean fasting glucose levels measured by 2 hour 75 gram oral glucose tolerance test (OGTT) at 6 weeks in women enrolled in an intensive behavioral educational program compared to women with GDM who undergo routine GDM education and counseling. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The IBEP Study | To evaluate the amount of weight lost in women enrolled in an intensive behavioral program and whether it correlates with more favorable lipid profiles at 6 weeks postpartum. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gestational diabetes
Isoniazid Dosage Prediction Model Development

Study Overview
=================
Brief Summary
-----------------
Isoniazid (INH) is an essential component of first-line anti-tuberculosis (TB) treatment. However, treatment with INH is complicated by polymorphisms in the expression of the enzyme system primarily responsible for its elimination, N-acetyltransferase 2 (NAT2), and its associated hepatotoxicity. The objective of this study was to develop an individualized INH dosing regimen using a pharmacogenetic-driven model and to apply this regimen in a pilot study.

Official Title
-----------------
Development of a Dosing Model Based on Anti-tuberculosis Drug Monitoring NAT2 Genotypes in Tuberculosis Patients.

Conditions
-----------------
NAT2 Genotype

Intervention / Treatment
-----------------
* Genetic: genotype


Participation Criteria
=================
Eligibility Criteria
-----------------
Eligible participants were patients newly diagnosed with active TB Who underwent standard four drug treatment for 6months: isoniazid (5 mg/kg, usually 300 mg), rifampin (450 mg for <50 kg or 600 mg for 50 kg body weight), ethambutol(15mg/kg), and pyrazinamide (20 - 30 mg/kg) Given daily for two months and followed by isoniazid and rifampin with or without ethambutol for four months. Those patients with abnormal hepatic function on laboratory testing (increased serum aspartate aminotransferase, alanine aminotransferase, or total bilirubin) before anti-TB treatment, underlying liver disease or systemic illness such as congestive heart failure, acute life-threatening disease, or alcoholism, or disease that was resistant to INH at the start of treatment were excluded.

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 80 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 |
| --- | --- |
| No Intervention: standard dosing<br>a standard treatment group; INH dose of 300 mg or 200 mg based on the body weight | |
| Experimental: Genotype-guided dosing<br>INH dose determined based on developed model | Genetic: genotype<br>* Patients were randomly assigned to a standard treatment group; INH dose of 300 mg or 200 mg based on the body weight) or model-based treatment group; INH dose determined based on developed model,<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum concentrations of INH |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NAT2 genotype guided dosing
Ezetimibe (+) Simvastatin vs. Atorvastatin Comparative Study in DM or Metabolic Syndrome Patients (0653A-093)

Study Overview
=================
Brief Summary
-----------------
An efficacy and safety study of ezetimibe (+) simvastatin compared to atorvastatin at week 6 in diabetics or metabolic syndrome patients in Korea.

Official Title
-----------------
A Multicenter, Randomized, Open-label Study to Evaluate the Lipid-Altering Efficacy and Safety of Ezetimibe (+) Simvastatin Versus Atorvastatin in Hypercholesterolemic Patients With Diabetes Mellitus or Metabolic Syndrome

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: simvastatin (+) ezetimibe
* Drug: atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of hypercholesterolemia Drug naive or statin treated but inadequately controlled patients against NCEP ATP III guideline goal Exclusion Criteria: Hypersensitivity to HMG-CoA inhibitor or Ezetimibe

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>1. simvastatin/ezetimibe 10/20mg | Drug: simvastatin (+) ezetimibe<br>* simvastatin (+) ezetimibe 10/20mg.<br>* Other names: Vytorin®;|
| Active Comparator: 2<br>2. atorvastatin 10mg | Drug: atorvastatin<br>* atorvastatin 10mg<br>* Other names: Lipitor®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL-C lowering efficacy |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  | 6 weeks |
Videoendoscopic Drainage of Infected Pancreatic Collections

Study Overview
=================
Brief Summary
-----------------
The VARD (Videoendoscopic Assisted Retroperitoneal Drainage) approach as treatment for necrotizing pancreatitis proposes an alternative to standard complicated open abdomen treatment methods. This treatment involves making a small incision and looking inside the abdomen with a videoendoscope. A videoendoscope is an instrument with a small camera and light on the end. It also has an extension tool that the surgeon can use to clean out any dead and infected tissue in the abdomen. This approach may reveal a treatment opportunity with faster recovery potential and shorter hospitalizations for patients with necrotizing pancreatitis.

Conditions
-----------------
Pancreatitis, Acute Necrotizing

Intervention / Treatment
-----------------
* Procedure: Videoscopic-Assisted Retroperitoneal Debridement (VARD)


Participation Criteria
=================
Eligibility Criteria
-----------------
Pancreatic necrosis or peripancreatic fluid collection following acute pancreatitis noted on CT scan Infected pancreatic necrosis or pancreatic abscess and determined by + FNA (gram stain or culture), as defined by the Atlanta Symposium Not neutropenic or pregnant No prior necrosectomy No pancreatic pseudocyst, either sterile or infected

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VARD<br>Videoscopic-Assisted Retroperitoneal Debridement (VARD) | Procedure: Videoscopic-Assisted Retroperitoneal Debridement (VARD)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infected pancreatic necrosis
Dual Mobility Cup in Total Hip Arthroplasty Preventing Dislocation in Patients at Risk

Study Overview
=================
Brief Summary
-----------------
Retrospectively study reviewing 34 patients operated with dual mobility cups in total hip arthroplasty between January 2009 and June 2012 at Sundsvall Hospital. Hypothesis: The dual mobility socket reduce the rate of dislocation in patient at high risk but increase the incidence of postoperative infection.

Detailed Description
-----------------
Retrospectively study reviewing 34 patients operated with dual mobility cups in total hip arthroplasty between January 2009 and June 2012 at Sundsvall Hospital. Indications for surgery is recurrent dislocation or patients at risk for dislocation after total hip arthroplasty suffering osteoarthritis or femoral neck fracture. Patients are followed recording complications, reoperations, functional outcome (Harris hip score and EQ5D) in june 2012.

Official Title
-----------------
Dual Mobility Cup in Total Hip Arthroplasty Preventing Dislocation in Patients at Risk

Conditions
-----------------
Femoral Neck Fracture, Osteoarthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: operated with an cemented dual mobility socket at Sundsvall hospital
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 |
| --- | --- | --- |
| Prosthetic dislocation | Incidence of postoperative dislocations of the prosthesis | 2012 (up to 3 years postoperatively) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication | Incidence of complications and reoperations | 2012 (up to 3 years postoperatively) | 
| Hip function | Patient reported hip function; Harris hip score | 2012 (up to 3 years postoperatively) | 
| Quality of life | Patient reported quality of life: EQ5D | 2012 (up to 3 years postoperatively) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hip surgery, dual mobility cup, dislocation, total hip arthroplasty