linjc16/ctgov huggingface dataset:
Conventional Direct Laryngoscopy Vs. Video Laryngoscopy With The C-MAC For Pyloromyotomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare two different ways of placing breathing tubes for surgery. Both ways are used currently to place breathing tubes and are safe and effective. This study seeks to determine if one way is better than the other for infants with pyloric stenosis.

Detailed Description
-----------------
Specific aims of this study include determining if there is a difference in the desaturation rates of the two different intubation techniques- Direct Laryngoscopy and the C-MAC video laryngoscope. Also is there a difference in intubation success between the two techniques, does intubation success vary with different training levels, and does desaturation rate differ among training levels.

Official Title
-----------------
Conventional Direct Laryngoscopy Vs. Video Laryngoscopy With The C-MAC For Pyloromyotomy

Conditions
-----------------
Pyloric Stenosis, Intubation, Pediatric

Intervention / Treatment
-----------------
* Device: Video Laryngoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Need general anesthesia for pyloromyotomy procedure Have been informed of the nature of the study and informed consent has been obtained from the legally responsible guardian Exclusion Criteria: Abnormal/difficult airway Allergy to succinylcholine and/or propofol

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

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conventional Direct Laryngoscopy<br>Endotracheal intubation will be performed by conventional direct laryngoscopy. | |
| Active Comparator: Video Laryngoscopy<br>Endotracheal intubation will be performed by video laryngoscopy with the C-MAC. | Device: Video Laryngoscopy<br> <br> * Other names: C-MAC;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Had Desaturation Below 80% During Intubation | Patient had a desaturation below 80% during intubation with either conventional laryngoscope or video laryngoscope | During intubation attempt (less than two minutes) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Storz C-MAC, direct laryngoscopy, pyloromyotomy, rapid sequence
ARDS Prediction Score in Critically Ill Patients in China

Study Overview
=================
Brief Summary
-----------------
ARDS is a severe disease, it's important to predict the incidence of ARDS.

Detailed Description
-----------------
From January 1 to January 31, 2012 and from January 1 to January 10, 2013 , all patients admit to the ICUs will be enrolled. The demographic characteristics, diagnosis, formerly medical history, Ventilator indications, Ventilator data, other respiratory treatments, weaning outcome and 28 day mortality will be recorded.

Official Title
-----------------
ARDS Prediction Score in Critically Ill Patients in China

Conditions
-----------------
ARDS, Septic Shock

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Critically ill patients who admitted into participating ICU Exclusion Criteria: Patients with chronic pulmonary disease such as chronic obstructive pulmonary disease (COPD), asthma, lung cancer, pulmonary fibrosis and tuberculosis Age less than 18 years old Pregnancy Died within 24 hours from ICU admission ARDS patients who diagnosed 24hours before ICU admission Referral from other hospital to participating ICU Lack of data of ARDS risk factors

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| incidence of ARDS | evaluate the incidence of risk factors of ARDS | up to 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mechanical ventilation, ARDS, Ventilator strategy, outcome
Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of ITI-214 in Patients With Heart Failure

Study Overview
=================
Brief Summary
-----------------
This is a Phase I/II randomized, double-blind, placebo-controlled, single rising dose study in patients with systolic heart failure to evaluate the safety and tolerability of ITI-214.

Official Title
-----------------
Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of Escalating Single Doses of ITI-214 in Patients With Systolic Heart Failure

Conditions
-----------------
Heart Failure, Systolic

Intervention / Treatment
-----------------
* Drug: ITI-214
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NYHA class II-III heart failure Ejection fraction equal to or below 35% On stable heart failure drug treatment Exclusion Criteria: Considered medically inappropriate for study participation

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 10 mg ITI-214<br>Single oral dose | Drug: ITI-214<br>* Oral<br>|
| Experimental: 30 mg ITI-214<br>Single oral dose | Drug: ITI-214<br>* Oral<br>|
| Experimental: 75 mg - 150 mg ITI-214<br>Single oral dose | Drug: ITI-214<br>* Oral<br>|
| Placebo Comparator: Placebo<br>Single oral dose | Other: Placebo<br>* Oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Echocardiogram with Doppler imaging and hemodynamic monitoring | Cardiac systolic and diastolic function | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12-lead electrocardiogram (ECG) | Safety and tolerability | 2 hours | 
| Hemodynamic monitoring | Cardiac systolic and diastolic function | 5-6 hours | 
| Number of patients with treatment-emergent adverse events | Safety and tolerability | 5 days |
The Laryngeal Mask Airway (LMA) Unique and the Air-Q Intubating Laryngeal Airway (ILA) in Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
The air-Q® intubating laryngeal airway (ILA) is an supraglottic device used for both airway maintenance during routine anesthesia and as a conduit for tracheal intubation for patients with a difficult airway. The investigators goal for this study is to compare the performance of the ILA with the current standard of care the standard LMA during routine anesthesia.

Detailed Description
-----------------
The goal for this randomized, crossover investigation is to compare a disposable version of the standard LMA, LMA Unique TM,with the air-Q ILA in pediatric patients. Oropharyngeal leak pressure is commonly used as an indicator of airway seal adequacy. Similarly, flexible fiberoptic bronchoscope examination is often employed to assess proper placement of airway devices. Our hypothesis is that the air-Q ILA is superior to the standard LMA in both these regards: We hypothesize that airway leak pressures will be higher with the ILA. Airway leak pressures will be measured by recording the circuit pressure at which an equilibrium is reached. We hypothesize that flexible fiberoptic view of the airway will be superior with the ILA. The airway view will be assessed using a previously used and published grading scale.

Official Title
-----------------
A Randomized Crossover Comparison Between the Air-Q Intubating Laryngeal Airway the Laryngeal Mask Airway-Unique in Children

Conditions
-----------------
Children

Intervention / Treatment
-----------------
* Device: each child will receive both the LMA and ILA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy children undergoing general anesthesia using a supraglottic airway device 6 months to 36 months of age 10 to 15 kilograms in weight Exclusion Criteria: Active respiratory infection History of difficult mask ventilation Features or history of a difficult airway Gastrointestinal reflux disease Clinically significant pulmonary disease

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 36 Months

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 |
| --- | --- |
| children weighing 10 to 15 kg<br> | Device: each child will receive both the LMA and ILA<br>* each child will receive both the size 2 LMA and size 1.5 ILA<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
-----------------
airway sealing pressure, fiberoptic assessment, ease and time for successful insertion, incidence of gastric insufflation, complications were also evaluated
Development for the Peritoneal Carcinomatosis Index (PCI) in Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
Primary objectives: To develop peritoneal carcinomatosis index (PCI) for ovarian cancer, tubal cancer and primary peritoneal cancer that can represent perioperative intraperitoneal tumor burden objectively Secondary objectives: To establish the relationship and find out clinical significance between PCI, tumor location and tumor characteristics

Detailed Description
-----------------
Patients with primary ovarian cancer Informed consent Digital photography & Checking PCI (tumor size, number, and Characteristics) Postoperative surveillance(tumor marker, image and physical examination) Developing the best fitting PCI model to reflect recurrence-free survival and overall survival Selection of items Weighting by items and tumor characteristics Analysis of prognostic impact of PCI compared to conventional staging system (FIGO stage) for ovarian cancer

Official Title
-----------------
A Clinical Trial to Develop a Peritoneal Carcinomatosis Index (PCI) in Ovarian

Conditions
-----------------
Ovarian Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preoperative clinical diagnosis of ovarian cancer, tubal cancer, and primary peritoneal carcinoma (all stage) Available preoperative image study (CT and/or MRI and/or PET) Patients who gave a written informed consent Patients must be surgical candidate considering medical and psychological condition Exclusion Criteria: Patients who refuse to participate or want to withdraw at anytime.
Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- | --- |
| Devleopment for the peritoneal carcinomatosis index (PCI) |  | 55 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PCI, Ovarian cancer
Clinical Study on BiHapro Total Hip System With Different Surface Coatings

Study Overview
=================
Brief Summary
-----------------
This post market study intends to evaluate the safety and the performance of BiHapro Total Hip System with two types of coatings.

Detailed Description
-----------------
The efficacy of the prosthesis will be evaluated comparing the pain, the function and the range of motion measured preoperatively and postoperatively using recognized clinical outcomes Harris Hip Score. The secondary efficacy measurement is based on X-rays to measure the mineral bony thickness in the areas of Gruen zones of the proximal femur.

Official Title
-----------------
Clinical Study on BiHapro Total Hip System With Different Surface Coatings

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Device: BiHapro hip stem with PPS Ti+Plasma HA
* Device: BiHapro hip stem with PPS Ti+BoneMaster HA


Participation Criteria
=================
Eligibility Criteria
-----------------
The patients who are selected for this study must fit the following criteria. Candidate for a Total Hip Arthroplasty Less than 80 years of age. A pre-operative level of pain and function the same as for conventional joint replacement. A likelihood of obtaining relief of pain and improved function. Full skeletal maturity. Ability to follow instructions. Good general health for age. Willing to return for follow-up evaluations. No bias to sex.

Ages Eligible for Study
-----------------
Maximum Age: 80 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 |
| --- | --- |
| with Plasma HA<br>BiHapro Hip stem with PPS Ti + Plasma HA | Device: BiHapro hip stem with PPS Ti+Plasma HA<br>* BiHapro hip stem with PPS Ti+Plasma HA<br>* Other names: BiHapro hip stem;|
| with BoneMaster HA<br>BiHapro Hip stem with PPS Ti + BoneMaster HA | Device: BiHapro hip stem with PPS Ti+BoneMaster HA<br>* BiHapro hip stem with PPS Ti+BoneMaster HA<br>* Other names: BiHapro hip stem;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score |  | annual at least to 5 yr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic Assessment |  | Annual; At least to 5 yr | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Total Hip Replacement
Extension Study of Original Protocol AERO C009 for Obstructive Sleep Apnea-hypopnea

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the long-term durability of the treatment and safety of the Provent device for those individuals who were enrolled in the C009 study, were diagnosed with obstructive sleep apnea-hypopnea (OSAH), and were actively using the Provent device.

Official Title
-----------------
A Single Arm, Open-label Extension Study to Evaluate the Long-term Durability of Treatment Response and and Safety of the Provent Professional Sleep Apnea Therapy Device for the Non-invasive Treatment of Obstructive Sleep Apnea-hypopnea

Conditions
-----------------
Obstructive Sleep Apnea Hypopnea, Obstructive Sleep Apnea, OSAH

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Based upon scoring at the study site, the 3-month 'device on' PSG has a 50% reduction in AHI compared to the 1-week 'device off' PSG AHI OR the 3-month 'device on' PSG AHI <10 Used the Provent device at least 4 hours for at least 5/7 nights per week on average during months 1 and 2 of the three month C009 study The study physician and investigator believe that continued Provent use does not represent a significant safety risk for the patient Patient understands and is willing and able to comply with study requirements Exclusion Criteria: 1. The patient must continue to not meet all of the exclusion criteria of protocol C009

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 |
| --- | --- |
| Provent<br>Provent Professional Sleep Apnea Therapy device | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure the percent change in the subject's apnea-hypopnea index (AHI) during the 12 month PSG while wearing the Provent device as compared to their AHI during the first week PSG when the subject did not wear the Provent device in the C009 study |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of the subjects quality of life |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obstructive sleep apnea hypopnea, OSA, OSAH
Three-Year Trial on a New Testosterone Gel

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to examine the efficacy and tolerability of a three-year-Testosterone replacement therapy in hypogonadal patients as well as the patient's compliance. The replacement therapy will be performed with a new Testosterone Gel examined in previous trials as Testosteron Gel Wolff.

Detailed Description
-----------------
The objective of the study is to examine the efficacy and tolerability of a three-year-Testosterone replacement therapy in hypogonadal patients as well as the patient's compliance. The replacement therapy will be performed with a new Testosterone Gel examined in previous trials as Testosteron Gel Wolff (TGW). A minimum of 100 patients will be recruited and evenly distributed to two treatment arms. 1st arm: dermal (non-scrotal) application of TGW. 2nd arm: scrotal application of TGW.

Official Title
-----------------
Three-Year Trial on a New Testosterone Gel: Clinical Efficacy, Tolerability and Compliance

Conditions
-----------------
Hypogonadism

Intervention / Treatment
-----------------
* Drug: Testosterone Gel Wolff


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: men with hypergonadotropic hypogonadism hypogonadotropic hypogonadism late-onset hypogonadism combined with an initial Testosterone serum level of < 11 nmol/l Exclusion Criteria: known or suspected carcinoma of the prostate clinically relevant abnormalities in clinical chemistry or haematology any severe medical conditions at the opinion of the investigator

Ages Eligible for Study
-----------------
Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Testosterone Gel Wolff|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| testosterone levels |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hormones |  |  | 
| sexual function and mood disorder (questionnaire) |  |  | 
| compliance (drug accountability) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypogonadism, Testosterone, Substitution
Conservative Treatment of Rectosigmoid Endometriosis Monitored by Transvaginal Ultrasound

Study Overview
=================
Brief Summary
-----------------
Background: Endometriosis is a disease affecting 8-15 % of fertile women and is a cause of abdominal pain and suffering during women's menstrual periods. A subgroup of patients with DIE has an infiltration into the rectosigmoid bowel wall (4-37%). Knowledge of the growth pattern of rectosigmoid lesions related to subjective symptoms is mandatory in order to assess the need for follow-up with transvaginal ultrasound during medical treatment. Hypotheses: Symptoms will follow growth of rectosigmoid endometriosis. Material and methods: Two different cohorts of women, based on time of diagnosis of rectosigmoid endometriosis and treatment with hormonal intrauterine device or continuous oral contraceptives will receive a questionnaire and a transvaginal ultrasound scan (measuring size and volume) at inclusion, (6) and 12 months later. Perspectives: Patients treated conservatively may be followed by questionnaires, thereby reducing the need for time consuming clinical controls.

Official Title
-----------------
Conservative Treatment of Rectosigmoid Endometriosis Monitored by Transvaginal Ultrasound

Conditions
-----------------
Bowel Endometriosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medically treated bowel endometriosis Exclusion Criteria: Age below 18 years Bowel resection of any kind Cancer

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

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

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 |
| --- | --- | --- |
| Transvaginal Ultrasound |  | 29 months |