linjc16/ctgov huggingface dataset:
Open Nipple Sparing Mastectomy (NSM)

Study Overview
=================
Brief Summary
-----------------
This is retrospective, multicenter chart review is to evaluate the complication rates of prophylactic open NSM procedures through 42 days postoperatively

Detailed Description
-----------------
This is retrospective, multicenter chart review is to evaluate the complication rates of prophylactic open NSM procedures through 42 days postoperatively

Official Title
-----------------
A Retrospective, Multicenter Study of Open Nipple Sparing Mastectomy (NSM)

Conditions
-----------------
Nipple Sparing Mastectomy

Intervention / Treatment
-----------------
* Procedure: Nipple Sparing Mastectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All female patients that have undergone open prophylactic NSM cases performed between January 1, 2018 through 42 days prior to IRB approval Exclusion Criteria: -

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Open<br>Prophylactic NSM cases by Open approach | Procedure: Nipple Sparing Mastectomy<br>* Prophylactic open NSM procedures<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Endpoint: complication rate | To assess the number of open prophylactic nipple sparing mastectomy complications compared to the number of procedures | IntraOperative period through 42 days postoperatively | 
| Effectiveness | Ability to completely excise memory gland tissue and preserve Nipple Areola Complex | IntraOperative period through 42 days postoperatively |
The VL3 Videolaryngoscope for Elective Tracheal Intubation in Adults

Study Overview
=================
Brief Summary
-----------------
We conducted an observational prospective pilot study to assess the efficacy of the VL3 videolaryngoscope for routinely tracheal intubation in 56 adults, in terms of successful rate, no. attempts and manoeuvre duration, including both normal and difficult airways.

Official Title
-----------------
The VL3 Videolaryngoscope for Elective Tracheal Intubation in Adults: a Prospective Pilot Study

Conditions
-----------------
Difficult Airway Intubation

Intervention / Treatment
-----------------
* Device: Videolaryngoscopy with VL3


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients candidates for general anesthesia in elective surgery Age over 18 years ASA physical status I-III. Exclusion Criteria: Paediatric population ASA physical status IV Emergency tracheal intubation

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: VL3<br>Tracheal intubation with VL3 videolaryngoscope | Device: Videolaryngoscopy with VL3<br>* Tracheal Intubation aided by VL3 Videolaryngoscope<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tracheal intubation rate | successful tracheal intubation rate using VL3 video laryngoscope | 30 minutes | 
| Number of attempts | Number of attempts for a successful tracheal intubation | 30 minutes | 
| Total time of intubation | Time needed to perform a tracheal intubation from the insertion of VL3 video laryngoscope into the patient mouth | 15 minutes | 
| Time to glottis visualization | Time needed to visualize the glottis from the insertion of VL3 video laryngoscope into the patient mouth | 15 minutes | 
| Cormack-Lehane grade | Cormack-Lehane grade observed at videolaryngoscopy | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for external laryngeal pressure | Need for external laryngeal pressure during laryngoscopy | 15 minutes | 
| Presence of post-laryngoscopy side effects | Presence of post-laryngoscopy side effects (bleeding, postoperative sore throat and/or dysphonia) | 3 days |
A Safety and Efficacy Study of Travoprost 0.004% Compared to Latanoprost 0.005% in Patients With Chronic Angle-Closure Glaucoma

Study Overview
=================
Brief Summary
-----------------
To demonstrate that the intraocular pressure(IOP)-lowering efficacy of Travoprost (0.004%) is equal or better than that of Latanoprost 0.005% in patients with chronic angle-closure glaucoma.

Official Title
-----------------
A Safety and Efficacy Study of Travoprost 0.004% Compared to Latanoprost 0.005% in Patients With Chronic Angle-Closure Glaucoma.

Conditions
-----------------
Glaucoma, Angle-Closure, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: Travoprost (0.004%)
* Drug: Latanoprost (0.005%)


Participation Criteria
=================
Eligibility Criteria
-----------------
Adult patients of any race and either sex with chronic angle-closure glaucoma.

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

| Intervention/Treatment |
| --- |
|Drug: Travoprost (0.004%)|nan|
|Drug: Latanoprost (0.005%)|nan|

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
-----------------
Glaucoma, POAG, OAG, OHT
Cereal-based Products Fortified With Legumes and Effects on Body Weight Management

Study Overview
=================
Brief Summary
-----------------
Legumes are high nutritional quality foods and constitute a rich source of proteins and dietary fibers which have been associated with appetite regulation and body weight management. The purpose of the study is to investigate the effects of regular consumption of a cereal-based snack fortified with legumes on body weight reduction.

Detailed Description
-----------------
Overweight/obese, non-diabetic subjects will participate in the study. Subjects will follow a 12-week energy-restricted dietary intervention supplemented with a certain amount of a cereal-based snack fortified with legumes daily. The effects of dietary intervention on body weight reduction will be examined.

Official Title
-----------------
Functional Cereal-based Products Fortified With Legumes for Satiety and Weight Management

Conditions
-----------------
Overweight and Obesity

Intervention / Treatment
-----------------
* Other: cereal-legume snack
* Other: cereal snack


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: normal exercise and dietary habits weight stable for at least 3 months before enrollment Exclusion Criteria: diabetes pregnancy chronic medical illness use of nutritional supplements regular intense exercise alcohol consumption > 2 drinks/day

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Overweight/obese non diabetic subjects will follow an energy-restricted diet and supplemented with a cereal-based snack fortified with legumes (intervention group) or a common cereal snack (control group) for 12 weeks. Body weight, anthropometric, clinical and biochemical characteristics will be evaluated at the beginning and at the end of the study.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cereal-legume snack<br>Certain amount of cereal-legume snack daily for 12 weeks | Other: cereal-legume snack<br>* cereal-legume biscuit<br>|
| Active Comparator: cereal snack<br>Certain amount of cereal snack daily for 12 weeks | Other: cereal snack<br>* cereal biscuit<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight | Change in body weight after energy-restricted dietary intervention with cereal-legume snack compared to common cereal snack | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cereal-based snack fortified with legumes, body weight reduction
Fasting Study of Alendronate Sodium Tablets (10 mg) and Fosamax Tablets (10 mg)

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to investigate the bioequivalence of Mylan's alendronate sodium 10 mg tablets to Merck's Fosamax 10 mg tablets following a single, oral 40 mg (4 x 10 mg) dose administration under fasting conditions.

Official Title
-----------------
Single-Dose Fasting In Vivo Bioequivalence Study of Alendronate Sodium Tablets (10 mg; Mylan) and Fosamax Tablets (10 mg; Merck) in Healthy Volunteers

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

Intervention / Treatment
-----------------
* Drug: Alendronate Sodium Tablets, 10 mg
* Drug: Fosamax Tablets, 10 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy, adult subjects, 18 years and older able to swallow medication Exclusion Criteria: institutionalized subjects history of any significant disease use of any prescription or OTC medications within 14 days of start of study received any investigational products within 30 days prior to start of study

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Alendronate Sodium Tablets, 10 mg | Drug: Alendronate Sodium Tablets, 10 mg<br>* 10 mg, single-dose fasting<br>|
| Active Comparator: 2<br>Fosamax Tablets, 10 mg | Drug: Fosamax Tablets, 10 mg<br>* 10 mg, single-dose fasting<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence |  | urine collection up to 36 hours |
Impact of Environmental Exposure at Home Address on One-year Post-myocardial Infarction Survival

Study Overview
=================
Brief Summary
-----------------
Numerous studies have explored the effects of environmental exposure to noise, air pollution and proximity to natural areas on various conditions. However, very few studies have focused on the post-diagnosis follow-up of patients after hospitalization for an ischemic cardiovascular episode and, to our knowledge, none have examined patient evolution at one year after myocardial infarction. Thus, the real influence of factors and pollutants widely represented in the urban environment, in particular air pollution, noise pollution, and proximity and accessibility to natural areas (green or blue spaces), on the evolution of post-myocardial infarction at one year remains to be identified and quantified. The objective of the ENVI-MI project is to evaluate the impact of environmental exposure in the place of residence (noise, air pollution, proximity to natural spaces) on the evolution of post-myocardial infarction at one year within the Dijon metropolitan area.

Official Title
-----------------
ENVI-MI (Environment and Myocardial Infarction) : Impact of Environmental Exposure at Home Address on One-year Post-myocardial Infarction Survival

Conditions
-----------------
Myocardial Infarction

Intervention / Treatment
-----------------
* Other: Collection of environmental exposure data


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient : registered in the RICO database hospitalized for MI between January 1, 2002 and December 31, 2008, whom residence is located in one of the 15 communes of the Dijon urban unit (except for patients living in the area subject to the noise exposure plan of the military airport) Exclusion Criteria: NA
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients registered in the RICO database<br>Patients hospitalized for myocardial infarction between 01/01/2002 and 31/12/2008 | Other: Collection of environmental exposure data<br>* noise pollution air pollution proximity and accessibility to green spaces, blue spaces<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of a cardiovascular event | Occurrence of any of the following cardiovascular events during the 1-year follow-up: death, recurrence, or rehospitalization for CV causes | 1 year |
Circadian as A Prognostic Factor For Radiation Response in Cervical Cancer

Study Overview
=================
Brief Summary
-----------------
The study was a Randomized Clinical Trial (RCT) or clinical trial comparing the results of radiation treatment of 2 treatment groups, i.e. subject groups irradiated in the morning and in the afternoon, to check melatonin levels in cervical cancer patients. Since it is known that the function of melatonin is as an antiproliferation substance or hormone, induces apoptosis, inhibits invasion and metastasis.

Official Title
-----------------
Influence of Radiation Patterns Following Circadian Rhythm Upon Response of Radiotherapy of Uterine Cervical Cancer : Melatonin as a Radiosensitivity and Biological Marker

Conditions
-----------------
Cervical Cancer, Radiotherapy Side Effect

Intervention / Treatment
-----------------
* Radiation: Afternoon Radiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cervical cancer patients stage IIB-IIIB (FIGO) no previous treatment histopathologic examination results of squamous cell carcinoma (SCC) KPS > 70 with levels of Hb > 10 g%, Exclusion Criteria: Distant metastasis and locally spread to the adjacent healthy tissue (urinary bladder or rectum).

Ages Eligible for Study
-----------------
Minimum Age: 25 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Morning Radiation<br> | |
| Active Comparator: Afternoon Radiation<br> | Radiation: Afternoon Radiation<br>* Melatonin, a hormone of the pineal gland, which levels are characteristic of circadian patterns, regulated with low levels of excretion in the afternoon, rises gradually during the night, peaks at dawn, and falls back in the afternoon and late afternoon. Many studies prove the function and potential of melatonin as circadian biomarkers and well correlated with the development of cancer.The function of melatonin is as an antiproliferation substance or hormone, induces apoptosis, inhibits invasion and metastasis.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation response | We assessed the change in tumor size between the initial examination and the fourth week after the completion of irradiation, to classify the tumor response based on the modified WHO criteria which categorized as good response or poor response. | Four weeks after the completion of radiation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radiosensitivity, Circadian rhythm
SALT - Success of Active Versus Passive Lead Fixation of Atrial Pacing/Sensing Electrodes

Study Overview
=================
Brief Summary
-----------------
Randomised Comparison with regards to complication rate and electrical measurements of atrial leads with different fixation mechnism

Detailed Description
-----------------
This investigation will study and compare 3 types of electrically identical, commercially available FineLine II Sterox leads with different fixation mechanisms. This trial has been designed to primarily study the difference in repositioning rate between active and passive fixation (straight and J-shaped) leads, if any. It will also monitor and document the behavior of the study leads, with special reference to electrical parameters and handling. Normal measurements are taken at pre-dicharge, 1-month 3-month and 12-month follow-up

Official Title
-----------------
Scandinavian Atrial Lead Trial

Conditions
-----------------
Bradycardia

Intervention / Treatment
-----------------
* Device: FineLine II Sterox, FineLine II Sterox, FineLine II Sterox EZ


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients selected for participation in this investigation should be candidates for permanent pacemaker implantation chosen from the investigator's general patient population without regard for race or sex. Furthermore, these patients should, in the physician's general opinion, benefit from permanent pacemaker implantation with one of the study leads. Patients should be geographically stable and available for routine follow-up visits throughout the duration of the study. Patients must also be able and willing to provide informed consent. Exclusion Criteria: Patients who previously went through heart surgery should be excluded from the study.

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

| Intervention/Treatment |
| --- |
|Device: FineLine II Sterox, FineLine II Sterox, FineLine II Sterox EZ|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of this study is to compare repositioning rate due to threshold > 3.0 V @ 0.5 ms or P-wave < 0.8 mV between FineLine II Sterox 4480 and 4470, and between 4456 and 4470. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Other complications (Safety). To compare other lead related complication rates such as perforation, lead fracture and failure to implant. 2. Electrical properties |  |  |
Sleep Quality and Related Factors in Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
Sleep quality is an important predictor of healthy status,quality of life and life span. Sleeping problems affect 50% 80% in hemodialysis patients. Sleep quality and related factors research in hemodialysis patients has been discussed and studied globally. Previous studies show insomnia, excessive daytime sleepiness(EDS), sleep apnea syndrome(SAS), restless legs syndrome(RLS) are major causes of poor sleep quality . There is few data to show the influential factors related to sleep quality in Taiwanese hemodialysis patients.

Detailed Description
-----------------
This study will be a cross-sectional design with purposive sample from 2 different dialysis medical centers in Taipei. Two hundred hemodialysis patients meeting inclusion criteria will be recruited.

Official Title
-----------------
Sleep Quality and Related Factors in Hemodialysis Patients

Conditions
-----------------
Haemodialysis-induced Symptom

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hemodialysis patient whose age ≧ 20 years old and conscious clear. ICD9：585.6 Every week receives two or three convention hemodialysis treatment above three months. May communication with Mandarin or Taiwanese language. Patient or caregiver is willing to participate study and sign the inform consent. Exclusion Criteria: Hospitalized hemodialysis patient in recently one month. Hemodialysis patient had conscious disturbance, blind or dementia. Hemodialysis Patient refuse to interview or fill out questionnaires.

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hemodialysis patients, sleep quality, restless legs syndrome, excessive daytime sleepiness, sleep apnea syndrome