linjc16/ctgov huggingface dataset:
The Effect Site Concentration of Remifentanil for Preventing QTc Interval Prolongation During Intubation in Normotensive and Hypertensive Patients

Study Overview
=================
Brief Summary
-----------------
To find out the effect site concentration of remifentanil for preventing QTc interval prolongation during intubation under propofol-remifentanil anesthesia in normotensive and hypertensive patients

Detailed Description
-----------------
It is known that anesthetic agents can influence the QTc. In addition, tracheal intubation during induction can stimulates sympathetic activity, which, as a results, prolong the QTc interval. Therefore, the aim of study is to find out the effect site concentration of remifentanil for preventing QTc interval prolongation during intubation under propofol-remifentanil anesthesia in normotensive and hypertensive patients.

Conditions
-----------------
Intubation, Intratracheal

Intervention / Treatment
-----------------
* Drug: Remifentanil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 50 years ASA class I-II female who received surgery with endotracheal intubation Exclusion Criteria: emergency surgery electrocardiography abnormality diabetes mellitus end stage renal disease moderate to severe cardiac disease moderate to severe liver dysfunction

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normotensive patients<br>To find out the effect site concentration of remifentanil for preventing QTc prolongation < 15 sec during intubation : Dixon's up-and-down method | Drug: Remifentanil<br>* The effect site concentration of remifentanil<br>|
| Experimental: Hypertensive patients<br>To find out the effect site concentration of remifentanil for preventing QTc prolongation < 15 sec during intubation : Dixon's up-and-down method | Drug: Remifentanil<br>* The effect site concentration of remifentanil<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect site concentration of remifentanil for preventing QTc interval prolongation |  | 2 min |
A Bioequivalence Study of Amlodipine Plus Losartan Versus Amlodipine and Losartan

Study Overview
=================
Brief Summary
-----------------
Study Design : A single center, open, randomized, single dose, two-period, two-treatment, two-sequence, crossover study Primary Objective: To assess the bioequivalence of combination oral formulation of amlodipine/losartan versus two co-administered products containing amlodipine and losartan

Detailed Description
-----------------
Secondary Objective: To evaluate the safety and tolerability of these formulations.

Official Title
-----------------
A Single-dose, Randomized, Two-period, Two-treatment, Two-sequence, Crossover Bioequivalence Study of Amlodipine and Losartan Versus Two Co-administration of Amlodipine and Losartan in Healthy Caucasian Subjects

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

Intervention / Treatment
-----------------
* Drug: Amlodipine plus Losartan
* Drug: Amlodipine, Losartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-55 years Healthy Caucasian volunteers Non smokers or mild smokers Exclusion criteria: Pregnancy and/or breast-feeding Participation in another clinical trial within 60 days prior to Period 1.

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amlodipine plus Losartan<br> | Drug: Amlodipine plus Losartan<br>* Amlodipine/Losartan low dose<br>|
| Active Comparator: Amlodipine, Losartan<br> | Drug: Amlodipine, Losartan<br>* Amlodipine, Losartan<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC, Cmax |  | 0-144hrs | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Amlodipine, Losartan
A Randomized Cross-over Trial of the Postprandial Effects of Three Different Diets in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The trial will study the acute metabolic effects of three different types of diet: low-fat diet, low-carbohydrate diet and Mediterranean diet. About 20 patients with diabetes mellitus type 2 will be recruited and each of them will be given each type of diet on three different days. Menus with the same energy content but with different content of fat, carbohydrate and protein are designed. Breakfast and lunch are served for the patients each day of testing. Laboratory samplings are performed six times during the day. The order of the dietary intervention is randomized for each patient. The investigators suppose to find different reaction in plasma glucose and lipids depending on the type of diet.

Official Title
-----------------
A Randomized Cross-over Trial of the Postprandial Effects of Three Different Diets in Patients With Type 2 Diabetes

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Dietary Supplement: Low-fat Diet
* Dietary Supplement: Low-carbohydrate Diet
* Dietary Supplement: Mediterranean Diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes mellitus type 2 Exclusion Criteria: Treatment with insulin or sulfonylurea

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 |
| --- | --- |
| Active Comparator: All test patients<br>All test patients are given low-fat, low-carbohydrate and mediterranean diet, in randomised order on different days. | Dietary Supplement: Low-fat Diet<br>* Low-fat Diet is provided for a breakfast and a lunch.<br>Dietary Supplement: Low-carbohydrate Diet<br>* Low-carbohydrate Diet is provided for a breakfast and a lunch.<br>Dietary Supplement: Mediterranean Diet<br>* Mediterranean Diet is provided for a breakfast and a lunch.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| P-glucose | mmol/l | 6 months | 
| P-Triglycerides | mmol/l | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| P-Cholesterol | mmol/l | 6 months | 
| P-LDL-Cholesterol | mmol/l | 6 months | 
| P-HDL-Cholesterol | mmol/l | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diet, Low-carbohydrate, Postprandial, Type 2 diabetes mellitus
Safety, Pharmacokinetics and Pharmacodynamics of TKI258 in Subjects With Acute Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
The primary objective is to determine the maximum tolerated dose (MTD), dose limiting toxicity (DLT), and safety profile of TKI258 when administered to subjects with acute myeloid leukemia (AML).

Official Title
-----------------
A Phase I Dose Escalating Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of TKI258 in Subjects With Acute Myeloid Leukemia

Conditions
-----------------
Acute Myeloid Leukemia

Intervention / Treatment
-----------------
* Drug: TKI258


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of Acute Myeloid Leukemia Eighteen years of age or older Life expectancy of at least 2 months Exclusion Criteria: Intracranial disease or epidural disease Clinically significant cardiac disease Diabetes mellitus uncontrolled with medication Pregnant or breast feeding women Dementia or altered mental status Known pre-existing clinically significant or uncontrolled disorder of the hypothalamic-pituitary axis, adrenal or thyroid glands Previous pericarditis Malabsorption syndrome or uncontrolled gastrointestinal symptoms such as nausea,diarrhea,vomiting

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TKI258 - dose escalation<br>Dose-Escalation | Drug: TKI258<br> <br> |
| Experimental: TKI258 - dose expansion<br>Dose-Expansion | Drug: TKI258<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose |  | 28 days - dose-escalation; 4 months - dose-expansion | 
| Dose limiting toxicity |  | 28 days - dose-escalation; 4 months - dose-expansion | 
| Safety profile |  | 28 days - dose-escalation; 4 months - dose-expansion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of plasma pharmacokinetics and pharmacodynamics |  | 28 days - dose-escalation; 4 months - dose-expansion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute, Myeloid, Leukemia
Overactive Bladder (OAB) Voiding Diary and Urodynamics Correlation Study

Study Overview
=================
Brief Summary
-----------------
This is a prospective cohort study study with the primary aim of identifying the strongest correlating parameters between voiding diaries and UDS studies most predictive for each type of urologic condition. Investigators will focus on OAB related conditions, as these are symptoms

Official Title
-----------------
Overactive Bladder (OAB) Voiding Diary and Urodynamics Correlation Study

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

Intervention / Treatment
-----------------
* Other: Voiding Diary
* Other: Urodynamics Correlation Study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: completing a bladder diary undergoing VUDS Exclusion Criteria: have a urinary tract infection neurogenic bladder history of pelvic irradiation prolapse alone without LUTS pregnant incarcerated hospital employee unable to give consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 110 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 |
| --- | --- |
| Voiding Diary<br> | Other: Voiding Diary<br>* A log kept by each patient to record frequency and volume of urine output and fluid input.<br>Other: Urodynamics Correlation Study<br>* Provides patho physiological data by assessing bladder sensation, bladder capacity, the presence of involuntary bladder contractions, bladder compliance and bladder outlet obstruction.<br>|
| Urodynamics Correlation Study<br> | Other: Voiding Diary<br>* A log kept by each patient to record frequency and volume of urine output and fluid input.<br>Other: Urodynamics Correlation Study<br>* Provides patho physiological data by assessing bladder sensation, bladder capacity, the presence of involuntary bladder contractions, bladder compliance and bladder outlet obstruction.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of urgency incontinence using Voiding Diary | patients will record urgency in diary | 60 Months |
Clamp-crush Technique Versus Harmonic Scalpel in Living Donor Hepatectomy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether clamp-crush technique for liver parenchymal transection is as safe as Harmonic scalpel device. outcomes will include: perioperative mortality, surgery-related complications, blood loss, amount of blood loss during hepatectomy, operating time, transection speed, markers of liver parenchymal injury and hospital stay.

Official Title
-----------------
Clamp-crush Technique Versus Harmonic Scalpel in Living Donor Hepatectomy. A Single Blinded Randomized Controlled Trial

Conditions
-----------------
Hepatic Transplantation

Intervention / Treatment
-----------------
* Device: Harmonic scalpel
* Device: Kelly clamp crush technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Liver right lobe donors Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| Active Comparator: Harmonic scalpel group<br>group of donors whom will undergo liver transection using harmonic scalpel. | Device: Harmonic scalpel<br>* a method for liver parenchymal transection<br>|
| Active Comparator: clamp-crush group<br>group of donors whom will undergo liver transection using Kelly clamp. | Device: Kelly clamp crush technique<br>* a method for liver parenchymal transection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood loss during hepatectomy | bleeding during transection phase will be calculated in mL. based on the blood in the sucker machine and the surgical towels | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| transection speed | the transection speed will be calculated in minutes based on the relation between the transecition time divided by the surface area of the raw area of the graft measured on the backtable. | intraoperative | 
| liver pathology from the cut margin | the area of necrosis will be measured in millimeters by the pathologist | intraoperative |
Heat Loss Prevention in Very Preterm Infants in Delivery Rooms: A Multicenter, Randomized, Controlled Trial of Polyethylene Occlusive Total Body Skin Wrapping

Study Overview
=================
Brief Summary
-----------------
Hypothermia after delivery is a world-wide problem associated with morbidity and mortality. The conventional approach of drying the baby with a pre-warmed towel and radiant warmers is unsuccessful in a large proportion of very preterm infants. Polyethylene occlusive skin wrapping covering the infant's body up to the neck will reduce postnatal heat loss in very preterm babies and represents the standard of care recommended by the International Guidelines for Neonatal Resuscitation. The use of a polyethylene head cap will also reduce heat loss 9 and its efficacy is comparable to that obtained with the wrap. However, the proportions of hypothermic infants at NICU admission (temperature <34°C) in the wrapped group (62%) as well as in the infants covered with a polyethylene cap (43%) remain high. The combination of body and head protection with a polyethylene wrap needs to be evaluated further. The investigators conducted a prospective, randomized, controlled trial in very preterm infants to evaluate whether a polyethylene total body wrapping (body plus head) prevents heat loss after delivery better than polyethylene occlusive wrapping.

Conditions
-----------------
Hypothermia, Preterm Infant

Intervention / Treatment
-----------------
* Device: Polyethylene wrap
* Device: Polyethylene wrap


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preterm infants <29 weeks' gestation born in the study centers Exclusion Criteria: Congenital anomalies with open lesions (e.g. gastroschisis, meningomyelocele) and babies whose delivery was not attended by the neonatal team

Ages Eligible for Study
-----------------
Minimum Age: 1 Minute
Maximum Age: 3 Minutes

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Total body polyethylene wrap (body plus head)<br>The entire body surface (body plus head) is covered by a polyethylene wrap | Device: Polyethylene wrap<br> <br> |
| Active Comparator: Polyethylene wrap (body)<br>A polyethylene wrap covers the patient's body up to the neck | Device: Polyethylene wrap<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axillary temperature taken on admission to the NICU (immediately after total body wrap and wrap removal) and again 1 hour later |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality prior to hospital discharge |  |  | 
| Major brain injury |  |  | 
| percentages of hyperthermic infants at NICU admission |  |  |
Iluvien Registry Safety Study

Study Overview
=================
Brief Summary
-----------------
The study will include any patient treated with Iluvien at designated sites in European countries where marketing authorization has been granted in order to obtain broader safety and usage information.

Official Title
-----------------
An Open Label, Registry Study of the Safety of Iluvien® 190 Micrograms Intravitreal Implant in Applicator

Conditions
-----------------
Chronic Diabetic Macular Oedema Considered Insufficiently Responsive to Available Therapies

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient treated with Iluvien under this protocol will be included in the study. Exclusion Criteria: Patients/Guardians who are unable to understand and sign the Informed Consent will be excluded from the study. Retrospective Enrollment Criteria Patients treated with ILUVIEN prior to study initiation may be included provided they satisfy the inclusion and exclusion criteria, where applicable, as well as, the following requirements: The site is allowed to enroll a patient who was treated with ILUVIEN no more than 36 months prior to bringing the patient in for their first study visit. The eligible patient must meet the data requirements as specified in the protocol, i.e., baseline data collected within 7 days prior to treatment with ILUVIEN and additional data subsequently collected approximately every 6 months thereafter until enrolment into the study. The eligible patient must be enrolled at least one year prior to the planned end of the study.
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 |
| --- | --- | --- |
| Number of participants with adverse events. |  | 5 years |
Dosing Vancomycin in Patients on Sustained Low Efficiency Daily Hemodiafiltration (SLEDD-f)

Study Overview
=================
Brief Summary
-----------------
Sustained low efficiency daily hemodiafiltration(SLEDD-f) is a kind of renal replacement therapy with high-flux dialyser membrane (helixone). The pore size of helixone is larger than most antibiotics, and vancomycin is supposed to be removed during dialysis. Our study wants to find the amount of vancomycin removed during SLEDD-f, and try to find the most appropriate dose regimen for this kind of patients.

Detailed Description
-----------------
Vancomycin is the most important antibiotic in the treatment of resistant G(+) bacteria infections. Close monitor of serum level is important to ensure its safety and effectiveness. So far there is not enough data to support the optimal dose regimen of vancomycin in patients on SLEDD-f. In this study, we draw blood levels between 2 doses of vancomycin to determine the pharmacokinetic parameters of vancomycin and fraction removed by SLEDD-f so as to determine the most appropriate dose regimen.

Official Title
-----------------
Pharmacokinetics and Dosing of Vancomycin in Sustained Low Efficiency Daily Hemodiafiltration (SLEDD-f)

Conditions
-----------------
Acute Renal Failure

Intervention / Treatment
-----------------
* Device: sustained low efficiency daily hemodiafiltration (SLEDD-f)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute renal failure of any cause Use SLEDD-f as renal replacement therapy Priscribe vancomycin for a known or suspected infection Exclusion Criteria: None

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 |
| --- | --- |
| SLEDD-f, vanco<br>Surgical ICU patients who is on slow low efficiency daily hemodiafiltration (SLEDD-f) and requires vancomycin therapy | Device: sustained low efficiency daily hemodiafiltration (SLEDD-f)<br>* vancomycin 15mg/kg IV infusion on day 1 from 6PM to 8PM. Start SLEDD-f on day 2 from 9AM to 5PM.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The amount of vancomycin removed during one course of SLEDD-f |  | 8 hr (during one course of SLEDD-f) | 
| The pharmacokinetics and dosing regimen of vancomycin in patients on SLEDD-f. |  | 26 hr | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vancomycin, SLEDD-f