linjc16/ctgov huggingface dataset:
Intubation Assist Clinical Study

Study Overview
=================
Brief Summary
-----------------
The Intubation Assist Clinical Study is an observational study of adult patients scheduled for elective surgery under general anesthesia to assess the user interface, assess transthoracic impedance by the ventilation volume and assess transthoracic impedance. Monitoring will begin at the time the patient is pre-oxygenated in preparation for endotracheal intubation and will continue until 30 minutes after intubation is achieved.

Official Title
-----------------
Intubation Assist Clinical Study

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

Intervention / Treatment
-----------------
* Device: Intubation Assist Dashboard


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Requiring intubation and assisted ventilation Patient undergoing elective surgery Able to give informed consent Exclusion Criteria: Skin condition that would interfere with electrodes Inability/failure to intubate Pregnancy Surgery that prevents the application of electrodes and monitoring equipment. Previous excision of complete or partial lung; congenital lung abnormalities.

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

| Intervention/Treatment |
| --- |
|Device: Intubation Assist Dashboard|The ZOLL X Series Intubation Assist Dashboard feature guides the operator through a three-step auscultation process to verify the proper placement of an endotracheal tube.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the user interface |  | Assessment will be made after using Intubation Assist approximately 30 minutes after successful intubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of transthoracic impedance |  | Impedance measurements will be collected during intubation and will not exceed 30 minutes from the start of intubation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intubation
Right Ventricular Dysfunction in Septic Shock Patients in ICU

Study Overview
=================
Brief Summary
-----------------
Assesment of right ventricular dysfunction in septic shock patients in intensive care unit.

Detailed Description
-----------------
Over the last decade, a few studies have highlighted the crucial role of right ventricular (RV) function in hemodynamic and respiratory diseases in critical care 1,2. However, RV failure is difficult to define in the critical care setting. A recent consensual definition proposed by different groups of experts characterizes RV failure as the association of a significant RV dilatation associated with systemic congestion 3-5. This definition is mainly physiologically based, not strictly validated, and the experts did not propose any threshold for RV size or congestion using critical care echocardiography (CCE) and central venous pressure (CVP), respectively. Fluid management in septic shock is crucial for prognosis, as fluid overload and high CVP are associated with a worse outcome 6. Septic shock is expected to impair RV function through the development of septic cardiomyopathy, but the incidence of RV failure is unknown.

Official Title
-----------------
Evaluation Of Right Ventricular Function In Septic Shock Patients In Intensive Care Unit.

Conditions
-----------------
Septic Shock

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with septic shock. Patients will be evaluated within 24 h after diagnosis. Exclusion Criteria: Patients diagnosed more than 24 hours. Patients with associated ischemic heart failure .
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 |
| --- | --- | --- |
| Right ventricular dysfunction in septic shock patients in intensive care unit | Fluid management in septic shock is crucial for prognosis, as fluid overload and high CVP are associated with a worse outcome 6. Septic shock is expected to impair RV function through the development of septic cardiomyopathy, but the incidence of RV failure is unknown. | 3 years |
Long Term Follow up of a Cohort of Children With TCF2 Mutation:Evolution of Endocrine and Renal Function

Study Overview
=================
Brief Summary
-----------------
Anomalies of renal development are well know for patients treated for MODY-5 diabetes due to TCF2 mutation.A recent study confirms the existence of pediatric patients having TCF2 mutation but presenting renal anomalies alone.Endocrine and renal evolution of these patients is unknown.The aim of this study is to follow a cohort of patients with TCF2 mutation and initially presenting renal anomalies alone.

Detailed Description
-----------------
Biologic analysis and renal ultrasonography once a year. After puberty or before kidney transplantation Abdominal and pelvic MRI Intravenous Glucose Tolerance Test

Official Title
-----------------
A Long Term Follow up of a Cohort of Children With TCF2 Mutation:Evolution of Endocrine and Renal Function

Conditions
-----------------
Hepatocyte Nuclear Factor 1-beta

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients presenting an anomaly of renal development due to TCF2 mutation Age<18 years old Exclusion Criteria: Anomaly of renal development without TCF2 mutation Age≥18 years old Parents or patients refusing to participate to the study

Ages Eligible for Study
-----------------
Maximum Age: 18 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
-----------------
HNF1B, TCF2, MODY-5, CAKUT, Anomaly of renal development
A Two Part Trial Investigating the Safety of NN9925 in Healthy Male Subjects

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability and bioavailability (exploring absorption of drug in body) of NN9925 in healthy male subjects.

Official Title
-----------------
Investigation of Safety, Tolerability and Bioavailability of NN9925 in Healthy Male Subjects

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2, Healthy

Intervention / Treatment
-----------------
* Drug: NN9925 (oral)
* Drug: NN9925 (i.v.)
* Drug: placebo
* Drug: NN9925 (oral)
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male subjects with good general health as judged by the physician Body weight of 65-95 kg (both inclusive) Body Mass Index (BMI) of 18.5-27.5 kg/m2 (both inclusive) Exclusion Criteria: Known or suspected allergy to trial product or related products Acute infection or inflammation or other illness that may confound the results of the trial or pose a risk to the subject by administering the trial product, as judged by the physician Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) or malabsorptive states of disease (celiac disease, lactose intolerance or chronic pancreatitis), as judged by the physician

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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: Trial part 1<br> | Drug: NN9925 (oral)<br>* Subjects will be randomised to receive a single dose of NN9925, at escalating dose levels. Progression to next dose will be based on safety evaluation<br>Drug: placebo<br>* Subjects will receive a single dose of placebo as a comparator to NN9925, at all dose levels<br>|
| Experimental: Trial part 2<br> | Drug: NN9925 (i.v.)<br>* As an active comparator, one standard dose will be given i.v. (into the vein) at one study visit<br>Drug: NN9925 (oral)<br>* Subjects will be randomised to receive a single dose of NN9925 in up to three different concentrations. The dose will be selected based on the results of part 1<br>Drug: placebo<br>* Subjects will be randomised to receive a single dose of placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and severity of adverse events (AEs) recorded |  | from dosing to Day 22 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The uptake in blood of oral NN9925 |  | from 0 to 504 hours |
Stylet Use for McGrath Videolaryngoscope

Study Overview
=================
Brief Summary
-----------------
The routine use of a styletted endotracheal tube during videolaryngoscopy is advocated by some manufacturers, but styletted endotracheal tube can elicit rare but potentially serious complications. We compared the intubation time and success rate whether or not use of stylet for endotracheal intubation with McGrath videolaryngoscope.

Official Title
-----------------
Comparison of With or Without Use of Stylet for Endotracheal Intubation With McGrath Videolaryngoscope

Conditions
-----------------
Orotracheal Intubation

Intervention / Treatment
-----------------
* Device: McGrath videolaryngoscope
* Device: McGrath videolaryngoscope with Intubating stylet (Mallinckrodt)
* Drug: rocuronium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists physical status I or II undergoing orotracheal intubation for elective surgery Exclusion Criteria: cervical spine injury rapid sequence induction body mass index> 35 kg/m2 airway pathology

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: no use of stylet<br>Endotracheal intubation was performed 2 min after rocuronium injection without use of stylet with McGrath videolaryngoscope after endotracheal tube was rolled up circularly for 3 min | Device: McGrath videolaryngoscope<br>* without use of stylet<br>Drug: rocuronium<br>* tracehal intubation was performed 2 min after rocuronium injection with McGrath videolaryngoscope<br>* Other names: rocumeron;|
| Active Comparator: use of stylet<br>Endotracheal intubation was performed 2 min after rocuronium injection using a styletted endotracheal tube with McGrath videolaryngoscope | Device: McGrath videolaryngoscope with Intubating stylet (Mallinckrodt)<br>* use of stylet<br>Drug: rocuronium<br>* tracehal intubation was performed 2 min after rocuronium injection with McGrath videolaryngoscope<br>* Other names: rocumeron;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intubation time | time the blade passed the lips until endtidal CO2 was detected | 2 min after rocuronium injection |
Studying the Analgesic Mechanism of the Cough-Trick

Study Overview
=================
Brief Summary
-----------------
The aim of the trial is to study the possible mechanism of the pain reducing effect of CT at peripheral venipuncture

Official Title
-----------------
Studying the Analgesic Mechanism of the Cough-Trick - Randomized Crossover Volunteer Study

Conditions
-----------------
Pain, Acute Pain, Venipuncture

Intervention / Treatment
-----------------
* Procedure: Venipuncture with cough-trick


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male volunteers aged 20-40 years, height 165-190 cm. Physical status I according to American Society of Anesthesiologists (ASA) classification. Straight run of the vein on the dorsum of the non-dominant hand at least 4 cm long and 3 mm thick No analgesics, anticoagulants and/or antiplatelet agents, sedatives or alcohol Exclusion Criteria: History of peripheral neuropathy Abnormal skin conditions (infection, scars, psoriasis, eczema) Unsuccessful venipuncture Inflamed site of VP within 1 week after VP

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Venipuncture with cough-trick|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity measured on VAS-100 scale |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate, arterial pressure, hand withdrawal, sweating |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute pain, pain on venipuncture, cough-trick, distraction
Candesartan Cilexetil in Heart Failure Assessment of Reduction in Mortality and Morbidity (CHARM Added)

Study Overview
=================
Brief Summary
-----------------
A study to evaluate the effect of Atacand on patients with heart failure with depressed left ventricular function

Official Title
-----------------
Candesartan Cilexetil in Heart Failure Assessment of Reduction in Mortality and Morbidity. Clinical Study of Candesartan in Patients With Heart Failure and Depressed Left Ventricular Systolic Function

Conditions
-----------------
Congestive Heart Failure

Intervention / Treatment
-----------------
* Drug: Candesartan
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged 18 or above Congestive Heart Failure with symptoms for more than 4 weeks before starting study Provision of informed consent Exclusion Criteria: Current low blood pressure with symptoms Liver disease considered significant by the study doctor Pregnant or lactating females

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: Candesartan<br> <br> * Other names: Atacand;|
| Placebo Comparator: 2<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular mortality or hospitalisation due to congestive heart failure |  | 2, 4, 6 weeks, 6 months, every 4 months thereafter until 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular mortality or hospitalisation for management of congestive heart failure, or non fatal MI |  | 2, 4, 6 weeks, 6 months, every 4 months thereafter until 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Congestive Heart Failure, Atacand, Candesartan
Study To Compare Safety and Pharmacokinetic Properties of Surfolase Capsule and HT-002-01 in Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
Study to compare safety and pharmacokinetic properties of surfolase capsule and HT-002-01 after oral administration for one day in healthy male volunteer.

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

Intervention / Treatment
-----------------
* Drug: Surfolase capsule
* Drug: HT-002-01


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy male subjects between the age of 20 and 55 years with body mass index between 18.5 and 25 Volunteers without apriority of chronic disease Volunteers must be in good health as determined by the investigator based on a detailed medical history, full physical examination, electrocardiogram, laboratory tests and urinalysis Volunteers who comply with the protocol, understand and sign an informed consent Exclusion Criteria: Sensitive response to acebrophylline and xanthine Galactose intolerance, Lapp lactase deficiency and Glucose-Galactose Malabsorption Known history of renal, hepatic, respiratory, neurologic, endocrine, cardiac vascular and hematopoietic disease, especially gallstone Known history of gastrointestinal disease which affects the absorption of medicine. Excluded by screening tests Upper limit of AST, ALT>1.25 times Upper limit of total bilirubin>1.5 times Estimated GFR<80mL/min/1.73m2) systolic blood pressure < 90 or > 150, diastolic blood pressure <50 or >100 Known history of drug abuse caffeine>5cups/day, alcohol>210g/week, 10 more cigarettes/day Use of any prescription drug within 14days or over-the-counter (OTC) medication within 7 days prior to dosing Participation in any clinical investigation within 60 days prior to study start Donation of blood within 60 days, donation of component blood within 30days Judged by the investigators to be undesirable as subjects

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Surfolase capsule & HT-002-01<br> | Drug: Surfolase capsule<br> <br> Drug: HT-002-01<br> <br> |
| Active Comparator: HT-002-01 & Surfolase capsule<br> | Drug: Surfolase capsule<br> <br> Drug: HT-002-01<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt, Cmax |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf, Tmax, t1/2 |  |  |
Use of Fish Skin Extracellular Matrix (ECM) to Facilitate Chronic Wound Healing

Study Overview
=================
Brief Summary
-----------------
The clinical study is designed to assess the effectiveness, safety and non-immunogenicity of fish skin wound dressing extracellular matrix (ECM) in treating chronic wounds. The wound dressing is indicated for the management of difficult to heal and chronic wounds. The matrix is cut to fit the wound and is applied to the wound bed. An absorptive secondary dressing is put on top. Further dressing of the wound depends on the etiology. The indications for use are: partial and full-thickness wounds pressure ulcers venous ulcers diabetic ulcers chronic vascular ulcers tunneled/undermined wounds trauma wounds (abrasions, lacerations, second-degree burns, and skin tears)

Official Title
-----------------
Chronic Wound Treatment With Extracellular Matrix (ECM) Scaffold Made From Fish Proteins

Conditions
-----------------
Pressure Ulcers, Venous Ulcers, Diabetic Ulcers, Chronic Ulcer of Foot, Trauma-related Wound

Intervention / Treatment
-----------------
* Device: Marigen Wound Dressing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Venous leg ulcer Arterial leg ulcer Rheumatic leg ulcer Hydrostatic leg ulcer Ulcer where healing is delayed because of drug therapy Non-healing ulcer due to known or unknown causes Exclusion Criteria: Active infection

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: Marigen Wound Dressing<br> | Device: Marigen Wound Dressing<br>* The dressing is changed at least twice a week, with no more than five days between dressing changes. It is extremely important that the dressings are changed sufficiently often. On highly exuding ulcers the three or four dressing changes per week may be necessary. Duration is four weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound granulation |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wound Healing, Adult, Aged, Aged, 80 and over, Bandages, Biological Dressings, Chronic Disease, Collagen, Epithelium, Extracellular Matrix, Fibroblasts, Granulation Tissue, Humans, Leg Ulcer, Middle Aged, Prospective Studies, Soft Tissue Injuries, Treatment Outcome, Varicose Ulcer, Wounds and Injuries