linjc16/ctgov huggingface dataset:
Clinical Trial of Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Oxygen in Women Having Planned Caesarean Delivery

Study Overview
=================
Brief Summary
-----------------
Clinical Trial of Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Oxygen in Women having Planned Caesarean Delivery. Cohort study investigating the efficacy of THRIVE pre-oxygenation using pre-determined number of vital capacity breaths and comparing the efficacy to face mask pre-oxygenation. Aimed to recruit ASA 1-2 term pregnant women having elective caesarean section.

Official Title
-----------------
Clinical Trial of Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Oxygen in Women Having Planned Caesarean Delivery

Conditions
-----------------
Pre-oxygenation in Term Pregnant Women

Intervention / Treatment
-----------------
* Device: THRIVE pre-oxygenation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: scheduled to undergo elective caesarean delivery singleton pregnancy American Society of Anaesthesiologists (ASA) Physical Status Grade II gestational age between 37 - 42 weeks Exclusion Criteria: multiple pregnancy pre-eclampsia known fetal abnormality maternal cardio-respiratory comorbidity Body Mass Index (BMI) > 35 kg/m2.
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: THRIVE pre-oxygenation|Clinical Trial of Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Oxygen in Women having Planned Caesarean Delivery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of vital capacity breaths required using THRIVE to pre-oxygenate 90% of parturients to an end tidal oxygen concentration of ≥90% (EN90). End tidal oxygen concentration >= 0.9 | measure end tidal oxygen concentration through breathing system attached to anaesthetic machine | 8 months study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EN90 using THRIVE with mouth open versus mouth closed | to measure any difference in end tidal oxygen concentration after using THRIVE mouth closed versus THRIVE mouth open | 8 months study period | 
| comfort score of THRIVE | using 4-point Likert scale (1 being very uncomfortable- 4 comfortable) | 8 months study period | 
| changes in fetal wellbeing during pre-oxygenation time | using fetal cardiotocography | 8 months study period |
A Randomized, Two-way, Crossover Study to Estimate the Relative Bioavailability of a Controlled-release Formulation of Oxycodone (40 mg) With Sequestered Naltrexone Compared With Immediate-release Oxycodone Tablets (20 mg) in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
To determine whether the bioavailability of the controlled-release test formulation is at least as high as that for the commercial reference drug.

Detailed Description
-----------------
Serial sampling of venous blood

Official Title
-----------------
An Open-label, Single-dose, Randomized, Two-way Crossover Study to Estimate the Relative Bioavailability of a Controlled-release Formulation of Oxycodone (40 mg) With Sequestered Naltrexone Compared With Immediate-release Oxycodone Tablets (20 mg) in Healthy Volunteers

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

Intervention / Treatment
-----------------
* Drug: Oxycodone controlled-release test formulation
* Drug: Immediate-release reference drug


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy volunteers, greater than 50 kg, able and willing to sign informed consent Exclusion Criteria: Evidence of significant illness, condition affecting drug absorption, history of sleep apnea, and allergy to opioid drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- |
| Treatment A<br>Controlled release oxycodone test formulation 40 mg | Drug: Oxycodone controlled-release test formulation<br>* single dose administration of test formulation under fasted conditions<br>* Other names: ALO-02;|
| Treatment B<br>Immediate release oxycodone reference drug 20 mg | Drug: Immediate-release reference drug<br>* single dose administration of reference drug under fasted conditions<br>* Other names: Roxicodone;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacokinetic endpoints - area under the concentration curve (AUC) |  | 0-48 hr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak concentration (Cmax) and time to peak concentration (Tmax) |  | 0-48 hr | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bioavailability, Oxycodone, Healthy Volunteers
PRP in Intracytoplasmic Sperm Injection

Study Overview
=================
Brief Summary
-----------------
Infertility is a major problem nowadays

Detailed Description
-----------------
ovarian and uterine factor of infertility are very hard to treat

Official Title
-----------------
Role of PRP in Intracytoplasmic Sperm Injection in Infertile Women

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Other: Platelet rich plasma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women with primary infertility Exclusion Criteria: women with unexplained infertility

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PRP<br>women who will receive PRP before ICSI | Other: Platelet rich plasma<br>* Giving women PRP before ICSI<br>|
| No Intervention: No PRP<br>women who willnot receive PRP before ICSI | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of women wo will have chemical pregnancy | how many women will have chemical pregnancy | within 3 months |
Chlorhexidine vs Povidone Iodine in Alcoholic Solutions for Prevention of Central Venous Catheter Infection

Study Overview
=================
Brief Summary
-----------------
The best antiseptic solution for cateheter care remains unknown.High concentration in aquous solution or low concentration in alcoholic solution of chlorhexidine actbetter than povidone iodine in aquous solutions. No study has compare alcoholic formulations of low concentration of chlorhexidine and povidone iodine for skin disinfection prior to insertion of central venous catheters. To compare the incidence of central venous catheter colonization after skin disinfection with either an alcoholic solution of povidone iodine or a combination of 0.5% chlorhexidine, 0.025% Benzalkonium and 4% benzylic alcohol. To compare the incidence of catheter related bacteremia in the to study groups. To compare the local and general tolerance of the two antiseptic formulations

Official Title
-----------------
Prevention of Central Venous Catheter Infections : Comparison of the Efficacy of Skin Disinfection With 5% Povidone Iodine in Alcoholic Solution Versus 0.25% Chlorhexidine, 0.025 Benzalkonium and 4% Benzylic Alcohol

Conditions
-----------------
ICU Patients Requiring a Central Venous Access

Intervention / Treatment
-----------------
* Drug: Skin disinfection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 yeras of age Requiring an internal jugular or sub-clavian central venous catheter for their care during at least 72 h Informed consent signed up Exclusion Criteria: Bacteriemic infection not under control extensive cutaneous infection Women with childbearing potential

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 |
| --- |
|Drug: Skin disinfection|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of catheter colonization |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of catheter related bacteremia |  |  | 
| Prevention of a positive culture of the catheter whaterver the threshold |  |  | 
| Local and general tolerance |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Central venous catheter, Skin disinfection, Antisepsis, Nosocomial infection, Catheter infection
Study of FemVue(TM) Sono Tubal Evaluation System Method Comparison to HSG

Study Overview
=================
Brief Summary
-----------------
Multi-center prospective comparison of fallopian tubal patency determination and uterine evaluation interventions using legally marketed devices for their intended purposes, and using each subject as their own control.

Detailed Description
-----------------
Study cancelled prior to recruitment.

Official Title
-----------------
A Comparative Study of Methods for Tubal Patency Determination and Uterine Cavity Evaluation: Sonography With the FemVue(TM) Catheter System vs. Hysterosalpingography (HSG)

Conditions
-----------------
Fallopian Tube Patency Tests

Intervention / Treatment
-----------------
* Device: Sonography with FemVue, and HSG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-pregnant women between the ages of 18 and 45 who desire to know the patency status of the fallopian tubes and if the uterine cavity is free of pathology who have: Been attempting conception for 6 months or A history of PID (including the conditions listed below) or Chlamydia Gonorrhea Endometriosis A history of pelvic surgery or Advanced maternal age (≥ 35) And Negative test for Gonorrhea/Chlamydia or prophylactic antibiotic treatment Without current bi-lateral tubal sterilization Signed Informed Consent Exclusion Criteria: Uterine anomaly or lesion(s) preventing catheter placement for either the FemVue or HSG procedure(as identified and documented by TVUS Screening procedure or the uterine cavity evaluation during the FemVue procedure or any previous diagnostic procedure) obstructing access to uterine cornu distorting fundus at the midline region

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sonography with FemVue vs. HSG<br>FemVue sonography and HSG | Device: Sonography with FemVue, and HSG<br>* Sono HSG for FDA 510(k) cleared indication for use<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance of evaluations of fallopian tube patency and intrauterine pathology. |  | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| subject discomfort assessment |  | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patency Tests, Fallopian Tubes, Hysterosalpingography, Sonography, Medical
Daily Protein Intake Distribution and MPS (ARCIII)

Study Overview
=================
Brief Summary
-----------------
To determine whether a balanced total daily dietary protein distribution supplemented with whey protein during a weight-loss intervention will result in increased muscle protein synthesis

Official Title
-----------------
Effect of Balanced Daily Protein Distribution Supplemented With Whey Protein on Muscle Protein Synthesis in Overweight Older Men During Calorie Restriction and Exercise (ARC III)

Conditions
-----------------
Overweight

Intervention / Treatment
-----------------
* Other: whey protein
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Overweight/obese (BMI 27-40 kg/m2) Non-smokers Non-diabetic No history of hyperlipidemia Not taking medications thought to interfere with study Considered generally healthy Exclusion Criteria: Efforts to lose weight in previous 16 weeks Hyperlipidemia Blood pressure ≥ 140/90 mmHg Smoking Heart and other organ disease Type 2 diabetes Gastrointestinal disease Orthopedic injury interfering with exercise Use of certain medications (HRT, antihypertensives, diuretics, antiarythmia medications, antiresorptive agents, anabolic agents, hypoglycemic agents, and statins known to affect muscle i.e. Simvastatin and Zocor)

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: whey protein<br>whey protein micelles | Other: whey protein<br>* whey protein.<br>|
| Placebo Comparator: placebo<br>calorie-free placebo | Other: placebo<br>* placebo.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscle protein synthesis | protein synthesis is evaluated in muscle biopsy tissue | up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body composition is evaluated using DEXA |  | up to 4 weeks |
Effect of Post-discharge Phone Calls on Patient Outcomes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a post-discharge telephone call to general medical patients discharged home will improve quality of care and adherence, and reduce hospital readmission.

Detailed Description
-----------------
Currently, discharge from hospital in many institutions is a confusing process for patients filled with uncertainty and potential for harm. For instance, 1 in 5 discharges results in a post discharge adverse event, many of which are related to medication errors. These may lead to serious harm and possibly require readmission to hospital. Telephone follow-up calls after discharge has been studied in small single-center trials and as a part of a coordinated, multi-layered discharge process but its direct effectiveness is not known. Understanding the impact of this simple intervention on patient outcomes is an important step towards improving patients' discharge from hospital.

Official Title
-----------------
Effect of Post-discharge Phone Calls on Patient Outcomes for General Internal Medicine Patients Discharged From a Teaching Hospital.

Conditions
-----------------
Transition

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admission to internal medicine ward Discharged to home Must have telephone access Exclusion Criteria: Discharged to care facility Lack of telephone access

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 |
| --- | --- |
| Post-discharge phone call<br>All patients in this group will receive a phone call within 72-hours of being discharged from hospital. | |
| Usual care (no phone call)<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Care Transition Measure-3 score (CTM-3) |  | 30-days post discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital readmission |  | 30-day post discharge | 
| Emergency department visit |  | 30-days post discharge | 
| Patient satisfaction |  | 30-days post discharge | 
| Treatment plan adherence |  | 30-days post discharge | 
| Outpatient provider follow-up rates |  | 30-days post discharge |
An Observational Study of Treatment Patterns and Effectiveness and Safety Outcomes in Advanced Basal Cell Carcinoma and Basal Cell Carcinoma Nevus Syndrome Patients(RegiSONIC)

Study Overview
=================
Brief Summary
-----------------
This multi-center, prospective, observational cohort study will evaluate the effectiveness, safety and utilization of treatments in patients with advanced basal cell carcinoma and basal cell carcinoma nevus syndrome. The total study duration is anticipated to be a maximum of 8 years, including 3 years for patient recruitment and 5 years follow-up.

Official Title
-----------------
A Prospective Observational Study of Treatment Patterns and Effectiveness and Safety Outcomes in Advanced Basal Cell Carcinoma and Basal Cell Carcinoma Nevus Syndrome Patients

Conditions
-----------------
Basal Cell Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 18 years of age Patients with basal cell carcinoma (BCC) who meet either of the following definitions: Patients who were determined with advanced disease (aBCC) within 90 days prior to study enrollment, have not been diagnosed with basal cell carcinoma nevus syndrome (BCCNS) and have not been treated with an investigational or approved hedgehog pathway inhibitor Patients with aBCC who have not been diagnosed with BCCNS and who were previously treated with vismodegib as part of Genentech study SHH4476g, SHH4437g, or SHH4811g (EAP) Patients with BCCNS who either have aBCC or multiple BCCs of any stage as defined by protocol (may include patients previously enrolled in Genentech study SHH4476g, SHH4437g, or SHH4811g (EAP)) Exclusion Criteria: Participation in a clinical trial within 90 days prior to study enrollment that has either involved treatment of aBCC or involved treatment with an investigational or approved hedgehog pathway inhibitor, except for patients treated with vismodegib as part of Genentech study SHH4476g, SHH4437g, or SHH4811g (EAP)

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | approximately 5 years | 
| Duration of response |  | approximately 5 years | 
| Recurrence rate |  | approximately 5 years | 
| Progression-free survival |  | approximately 5 years | 
| Overall survival |  | approximately 5 years | 
| Safety: Incidence of adverse events |  | approximately 5 years |
Evaluation of Comfort in Symptomatic Contact Lens Wearers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the comfort of an ocular lubricant in symptomatic contact lens wearers. This study will be conducted in Canada.

Detailed Description
-----------------
The duration of individual participation is six days.

Official Title
-----------------
Evaluation of Comfort in Symptomatic Contact Lens Wearers

Conditions
-----------------
Ocular Comfort

Intervention / Treatment
-----------------
* Other: FID123238


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Is able to understand and sign an approved information consent letter; Habitually wears daily disposable soft contact lenses in both eyes; Is able to achieve 20/40 or better monocular VA with habitual contact lenses; Has a pair of spectacles for vision correction. Other protocol-defined inclusion criteria may apply. Key Exclusion Criteria: Routinely sleeps in habitual contact lenses; Has any known active ocular disease and/or infection; Is pregnant or lactating; Other protocol-defined exclusion criteria may apply.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FID123238<br>FID123238 applied to the ocular surface, 1 application per day, for five consecutive days | Other: FID123238<br>* Lubricant applied to the ocular surface<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort, collected for each eye | A visual analogue scale will be used | Up to Day 6 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Contact Lenses