linjc16/ctgov huggingface dataset:
Effects of Dexmedetomidine and Propofol on Pulmonary Mechanics

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare the effects of dexmedetomidine and propofol on pulmonary mechanics in intensive care patients.

Detailed Description
-----------------
The aim of this study is to compare the effects propofol and dexmedetomidine on pulmonary mechanics. Sixty patients mechanically ventilated in intensive care unit are included in this study. Patients are divided into two random groups, Group P (propofol) and Group D (dexmedetomidine). Propofol infusion 0.5-2 mg/kg/h is given to Group P patients and dexmedetomidine infusion 0.2-0.7 mcg/kg/h is given to Group D patients for sedation. Initial blood gas analysis, airway resistance (cmH2O/L/sec), positive end-expiratory pressure (PEEP, cmH20), frequency (breath/min), tidal volume (mL/min), minute volume (mL), peak airway pressure (cmH20), compliance (mL/cmH20), endtidal CO2 (mmHg), SvO2 (%) values are recorded. This parameters are evaluated with Drager Evita 4 ventilator and recorded on 5th,15th,30th,45th ve 60th minutes . Sedation is observed using Riker and Ramsey Sedation-Agitation Scale. Compliance of patients to mechanical ventilation is observed and recorded. The primary outcome measures are airway resistance and peak airway pressure. Secondary outcome measure is sedation score.

Conditions
-----------------
Abnormal Respiratory Airway Resistance

Intervention / Treatment
-----------------
* Drug: propofol
* Drug: dexmedetomidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients mechanically ventilated in intensive care unit Exclusion Criteria: Patients with contraindications for using propofol and dexmedetomidine

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: propofol<br>Propofol infusion 0.5-2 mg/kg/h for sedation in mechanically ventilated patients | Drug: propofol<br> <br> |
| Active Comparator: dexmedetomidine<br>dexmedetomidine infusion 0.2-0.7 mcg/kg/h for sedation in mechanically ventilated patients | Drug: dexmedetomidine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| airway resistance | airway resistans measured by Evita 4 ventilator flow sensor | 60 minutes | 
| peak airway pressure values | peak airway pressure values provide the methods used to Evita 4 ventilator flow sensor | 60 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sedation, peak airway pressure, airway resistance, intensive care
MITO-5: Weekly Carboplatin and Paclitaxel as First Line Chemotherapy for Elderly Patients With Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the toxicity and activity of weekly administration of carboplatin and paclitaxel as first-line chemotherapy for elderly patients with ovarian cancer stage IC-IV.

Detailed Description
-----------------
This is a phase II multicenter study. The experimental treatment is carboplatin (AUC 2) and paclitaxel 60 mg/m2, on days 1, 8 and 15 every 28 days.

Official Title
-----------------
Phase II Multicenter Study of the Combination of Weekly Carboplatin and Paclitaxel as First-line Chemotherapy for Elderly Patients With Ovarian Cancer.

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

Intervention / Treatment
-----------------
* Drug: carboplatin
* Drug: paclitaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 70 years or greater Cytologic / histologic diagnosis ovarian cancer Stage of disease at diagnosis IC -IV Performance status (ECOG) < 3 Indication for chemotherapy treatment Written informed consent Exclusion Criteria: Previous or concomitant malignant neoplasia (not including basocellular or spinocellular skin carcinoma or in-situ carcinoma of the uterine cervix, provided they are being adequately treated) Cerebral metastases Neutrophils < 1000/mm3, platelets < 100000/mm3, hemoglobin < 8g/dl Creatinine > o = 1.25 times the upper normal limit GOT or GPT > o = 1.25 times the upper normal limit, except in case of liver metastases) Patient's inability to comply with followup

Ages Eligible for Study
-----------------
Minimum Age: 70 Years

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

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: SINGLE ARM<br> | Drug: carboplatin<br> <br> Drug: paclitaxel<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate |  | 6 month | 
| Toxicity | assessed weekly | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| possible predictive factors of the geriatric ADL and IADL scales |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ovarian cancer, elderly, weekly chemotherapy, first-line
Study Assessing an Insulin Pump-controlling Algorithm to Minimize Hypo and Hyper in Type 1 During CRC Setting

Study Overview
=================
Brief Summary
-----------------
Feasibility study assessing the ability of an insulin pump-controlling algorithm to minimize hypoglycemia and hyperglycemia in patients with type 1 diabetes in a clinical research setting.

Detailed Description
-----------------
This study is a non-randomized, uncontrolled feasibility study that looks to enroll people with type 1 diabetes who are currently using an insulin pump. During the subject's participation, the study staff will closely monitor the study subject in a clinical research center environment for approximately 30 hours, while controller algorithm determined insulin doses are delivered by an insulin pump, and utilizing continuous glucose monitoring results.

Official Title
-----------------
Feasibility Study Assessing the Ability of an Insulin Pump-controlling Algorithm to Minimize Hypoglycemia and Hyperglycemia in Patients With Type 1 Diabetes in a Clinical Research Setting

Conditions
-----------------
Type 1 Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: Hypo-Hyper Minimizer (HHM) System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 21-65 years type 1 diabetes mellitus for at least one year Currently using an insulin infusion pump for at least the past 6 months Exclusion Criteria: Pregnancy History of Diabetic Ketoacidosis (DKA) in the past six months Histoey of severe hypoglycemia (Seizure, unconsciousnesss) in the past 6 months

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 Years

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

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

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: Hypo-Hyper Minimizer (HHM) System<br> | Device: Hypo-Hyper Minimizer (HHM) System<br>* Adjustment of Insulin dosing during meal time<br>* Other names: Insulin delivery;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the performance of the HHM system response to meal insulin while the subject is under close medical supervision in the Clinical Research Center (CRC) setting. |  | After subject is discharged from CRC, 1 week after enrolment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Safety Events and any additional information that can be used for product development |  | After subject is discharged from CRC, 1 week after enrolment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 1 Diabetes Mellitus, Artificial Pancreas
Out-of-hospital Cardiopulmonary Resuscitation and AED Feedback

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether an online automatic feedback improved CPR quality (No-flow time, compression depth, short-term survival and one year follow up) in this prospective randomised study of out-of-hospital cardiac arrest

Official Title
-----------------
Quality of Out-of-hospital Cardiopulmonary Resuscitation (CPR) With Real Time Automated Feedback: a Prospective Randomized Study

Conditions
-----------------
Cardiac Arrest, Resuscitation

Intervention / Treatment
-----------------
* Device: Zoll AED pro
* Device: Zoll AED pro


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cardiac arrest Exclusion Criteria: age under 18 years

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. Extended feedback<br> | Device: Zoll AED pro<br>* Arm one (Extended feedback) offers full feedback guidance during CPR<br>|
| Active Comparator: 2. Limited feedback<br> | Device: Zoll AED pro<br>* In arm two (limited feedback) feedback is modified lacking several elements of feedback<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ratio of patients with spontaneous circulation |  | admission to the hospital | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of hospital stay |  | hospital discharge | 
| neurological status |  | hospital discharge | 
| neurological status |  | one year after resuscitation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AED (automated external defibrillation), feedback, out of hospital resuscitation
Insulin Resistance in Idiopathic Oligospermia and Azoospermia

Study Overview
=================
Brief Summary
-----------------
Insulin resistance in men can be the underlying major factor in reproductive abnormalities ( chronic hypospermatogenesis ) as well as metabolic abnormalities similar to polycystic ovarian syndrome ( PCOS ) in women.

Detailed Description
-----------------
During the past decade IR has been recognized as a major contributor to the pathogenesis of chronic anovulation, hyperandrogenism and metabolic abnormalities associated with PCOS . Theoretically IR in men may result in a similar reproductive abnormalities ( chronic hypospermatogenesis ) as well as other metabolic abnormalities similar to what happens in PCOS in women .

Official Title
-----------------
Insulin Resistance : a New Diagnosis of the Pathogenesis of Idiopathic Oligozoospermia and Non Obstructive Azoospermia

Conditions
-----------------
Insulin Resistance, Oligospermia, Azoospermia

Intervention / Treatment
-----------------
* Other: blood samples
* Other: Blood samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: sperm count less than 10 million per milliliter non-obstructive azoospermia Exclusion Criteria: high FSH ( > 10 mIU/ ml ) high prolactin ( > 36 mIU/ml ) abnormal karyotype AZF

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: insulin resistance<br>unexplained oligospermia and azoospermia. Blood samples will be taken for hormonal and blood lipids analysis. | Other: blood samples<br>* blood samples to test for primary and secondary outcome measures<br>* Other names: Unexplained oligospermia and azoospermia;|
| Active Comparator: Fertile males<br>Healthy Men with proven fertility. Blood samples will be taken for hormonal and blood lipids analysis | Other: Blood samples<br>* IR Cholesterol HDL LDL Fasting Glucose Triglycerides<br>* Other names: Hypospermatogenesis;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum insulin |  | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Glucose |  | one month | 
| cholesterol |  | one month | 
| high density lipoprotein ( HDL) |  | one month | 
| Low density lipoprotein ( LDL ) |  | one month | 
| testosterone |  | one month | 
| Triglycerides |  | One month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
insulin resistance, unexplained azoospermia, unexplained oligospermia
Drug Use-Results Survey of Betanis Tablets in Japan

Study Overview
=================
Brief Summary
-----------------
This study is to determine the following information. The occurrence of adverse drug reactions in clinical settings. Factors potentially impacting safety, effectiveness, and other aspects.

Detailed Description
-----------------
This survey aims to determine the following information and the need for conducting specified drug use-results surveys and post-marketing clinical studies in patients using Betanis (generic name: mirabegron): The occurrence of adverse drug reactions in clinical settings. Factors potentially impacting safety, effectiveness, and other aspects. Items of Particular Interest: Safety and effectiveness in patients with hepatic impairment and patients with renal impairment. Safety and effectiveness when mirabegron is used concomitantly with other drugs (α1 blockers, anticholinergic agents, 5α reductase inhibitors, drugs with a potent CYP3A4-inhibiting effect, drugs with a CYP3A4-inducing effect, drugs metabolized primarily by CYP2D6, and other frequently used drugs). The occurrence of cardiovascular adverse events. The occurrence of adverse events related to increased intraocular pressure. The occurrence of urinary retention

Official Title
-----------------
Drug Use-Results Survey of Betanis Tablets 25 and 50 mg

Conditions
-----------------
Overactive Bladder

Intervention / Treatment
-----------------
* Drug: Betanis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who received mirabegron for the first time for the treatment of urinary urgency, daytime frequency, and urgency incontinence associated with overactive bladder.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Betanis group<br>Patients receiving Betanis for Overactive Bladder | Drug: Betanis<br>* Oral<br>* Other names: YM178;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse events and adverse drug reactions |  | For 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in OABSS (overactive bladder symptom score) |  | baseline and at 12 weeks (or last observation period) | 
| Items of particular interest |  | baseline and at 12 weeks (or last observation period) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
overactive bladder, mirabegron, occurrence of adverse events, Overactive Bladder Symptom Score
Real-time Eye Tracking and Imaging of the Eye in Diabetic Retinopathy Patients

Study Overview
=================
Brief Summary
-----------------
Diabetic retinopathy (DR) is a leading cause of vision loss in working age Canadians. Current treatment consists of early detection and laser photocoagulation therapy for preventing progressive or severe vision loss. Microaneurysms (MA) are the earliest, clinically visible changes of DR, which are visualized using specialized imaging technologies. PulseMedica is developing a three-dimensional (3D) retinal imaging system with real-time eye tracking capabilities. The purpose of this study is to assess the feasibility of PulseMedica's prototype device, the OSNAT800 Imaging Only (IO), in providing real-time tracking of eye movements in patients with DR. It is hypothesized that the OSNAT 800 IO will be able to perform real-time eye tracking while imaging patients with DR.

Official Title
-----------------
Scanning Laser Ophthalmoscopy Registered Optical Coherence Tomography for Real-Time Eye Tracking

Conditions
-----------------
Diabetic Retinopathy, Retinal Imaging

Intervention / Treatment
-----------------
* Device: OSNAT 800 IO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between 18 and 70 years of age Male or female Diagnosed diabetic retinopathy Two eyes with clear ocular media Exclusion Criteria: Patients younger than 18 years and over 70 years of age Patients without diabetic retinopathy Opacification of cornea, lens, or vitreous

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Retinal Imaging using the OSNAT800 IO device<br>Patients will have their eyes imaged with the OSNAT800 IO device in addition to a routine standard of care appointment. | Device: OSNAT 800 IO<br>* Real-time, combined scanning laser ophthalmoscope (SLO) and optical coherence tomography (OCT) for retinal imaging<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful performance of the real-time eye tracking function by post-image processing | Successful acquisition of retinal images | Through study completion, an average of 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device usability as assessed by a survey | Qualitative assessment of user feedback | Through study completion, an average of 6 months | 
| Image Quality as assessed by user assessment of image quality parameters | Qualitative assessment of image at time of acquisition | Through study completion, an average of 6 months |
Recurrence of Bladder Cancer After Transurethral Resection With Hexvix

Study Overview
=================
Brief Summary
-----------------
This is a randomised, comparative, multicentre study to determine if the early recurrence rate of intermediate-risk bladder cancer is similar in subjects treated with multiple instillations of mitomycin C after resection conducted under white light cystoscopy (group A) and subjects treated with 1 instillation of mitomycin C after resection conducted under white light and blue light cystoscopy (group B).

Official Title
-----------------
Recurrence of Bladder Cancer After Transurethral Resection With Hexvix

Conditions
-----------------
Bladder Cancer

Intervention / Treatment
-----------------
* Drug: hexaminolevulinate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject is not of childbearing potential and signed informed consent. Subject with 1 or more primary bladder tumours, confirmed on an outpatient cystoscopy or subjects with 1 or more recurrent bladder tumours appearing within 12 months of removal of a previous bladder tumour, confirmed on an outpatient cystoscopy. Exclusion Criteria: The subject was previously included in this study. The subject has a history/is suspected to have TaG3 or greater than or equal to T1 tumours or carcinoma in situ (CIS). The subject is suspected to have single primary or single recurrent TaG1 tumours when recurrence occurs more than 1 year after initial diagnosis or previous recurrence. The subject has known tumours in the prostatic urethra, distal urethra, or upper urinary tract. The subject has gross haematuria. The subject has a history of porphyria.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: B<br>One instillation of mitomycin C after transurethral resection in white and blue fluorescence light with Hexvix. | Drug: hexaminolevulinate<br>* Instillation of 50mL of 8mM Hexvix into the bladder through a catheter.<br>* Other names: Hexvix;|
| No Intervention: A<br>Multiple instillations of mitomycin C after transurethral resection in white light alone. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of bladder cancer recurrence |  | 12 Months |