linjc16/ctgov huggingface dataset:
Safety and Efficacy of INCB013739 Plus Metformin Compared to Metformin Alone on Glycemic Control in Type 2 Diabetics

Study Overview
=================
Brief Summary
-----------------
Determine the effect of treatment with INCB013739 administered as an 'add-on' to metformin therapy in type 2 diabetic subjects on safety and tolerability and glycemic control.

Official Title
-----------------
Randomized Study to Evaluate the Safety and Efficacy of INCB013739 Plus Metformin Compared to Metformin Alone on Glycemic Control in Type 2 Diabetic Subjects

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

Intervention / Treatment
-----------------
* Drug: INCB013739
* Drug: INCB013739
* Drug: INCB013739
* Drug: INCB013739
* Drug: INCB013739
* Drug: Placebo comparator matching INCB013739
* Drug: Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Established diagnosis of Type 2 Diabetes Stable dose of metformin for more than 8 weeks Exclusion Criteria: Subjects with Addison's disease or Cushing's Syndrome Type 1 diabetes mellitus or secondary forms of diabetes Subjects with uncontrolled thyroid disease History of renal impairment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A - INCB013739 & Metformin<br>INCB013739 5 mg QD and Metformin | Drug: INCB013739<br>* INCB013739 5 mg QD tablet<br>Drug: Metformin<br> <br> |
| Experimental: Treatment B - INCB013739 & Metformin<br>INCB013739 15 mg QD and Metformin | Drug: INCB013739<br>* INCB013739 15 mg QD tablet<br>Drug: Metformin<br> <br> |
| Experimental: Treatment C - INCB013739 & Metformin<br>INCB013739 50 mg QD and Metformin | Drug: INCB013739<br>* INCB013739 50 mg QD tablet<br>Drug: Metformin<br> <br> |
| Experimental: Treatment D - INCB013739 & Metformin<br>INCB013739 100 mg QD and Metformin | Drug: INCB013739<br>* INCB013739 100 mg QD tablet<br>Drug: Metformin<br> <br> |
| Experimental: Treatment E - INCB013739 & Metformin<br>INCB013739 200 mg QD and Metformin | Drug: INCB013739<br>* INCB013739 200 mg QD<br>Drug: Metformin<br> <br> |
| Placebo Comparator: Treatment F - Placebo<br>Matching placebo | Drug: Placebo comparator matching INCB013739<br>* Orally once daily tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline to Week 12 in hemoglobin A1c (HbA1c) |  | Baseline and Week 12 (or early termination study visit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline to Week 12 in fasting plasma glucose (FPG). |  | Baseline and Week 12 (or early termination study visit) |
Comparison of the Efficacy of PENG Block in Combination With LFCN Block and Wound Infiltration

Study Overview
=================
Brief Summary
-----------------
The ultrasound-guided approach for the blockade of articular branches of femoral and obturator nerves, pericapsular nerve group (PENG) block, is an effective method for postoperative analgesia in hip surgeries.

Detailed Description
-----------------
The ultrasound-guided approach for the blockade of articular branches of femoral and obturator nerves, pericapsular nerve group (PENG) block, is an effective method for postoperative analgesia in hip surgeries. However, it fails to provide cutaneous analgesia on the anterolateral surgical incisional site. This study compares the effects of wound infiltration and lateral femoral nerve blocks in combination with PENG blocks for postoperative pain in patients undergoing total hip arthroplasty for coxarthrosis.

Official Title
-----------------
Postoperative Pain Management in Patients Undergoing Total Hip Arthroplasty: PENG Block in Combination With LFCN Block or Wound Infiltration?

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Procedure: LFCN
* Procedure: Wound infiltration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Coxarthrosis Total hip replacement Patients agreed to receive PENG block LFCN or wound infiltration performed combined with PENG blocks Exclusion Criteria: Other kinds of hip surgeries Total hip replacement performed for other indications Patients refused to receive PENG block

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LFCN<br>Patients received LFCN + PENG blocks | Procedure: LFCN<br>* LFCN block was performed in combination with PENG block<br>|
| Wound Infiltration<br>Patients received wound infiltration + PENG blocks | Procedure: Wound infiltration<br>* Wound infiltration was performed in combination with PENG block<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First analgesic demand | The time interval from PENG blocks to the first analgesic demand. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption | Total opioid analgesic consumption | 24 hours | 
| Numeric Rating Scale | The maximum score on a 10cm numeric rating scale: (0 to 10cm) (0 = no pain, 10 = worst imaginable pain) | 24 hours | 
| Nonsteroidal Anti-inflammatory Drugs (NSAID) | Total NSAID consumption | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coxarthrosis, Regional Anesthesia, Total Hip Replacement
Management of Anxiety in Intensive Care Unit Including Olfactotherapy

Study Overview
=================
Brief Summary
-----------------
The OCEAN observational study is a pilot study. The aim is to validate the interest of the intervention of essential oils, relaxing music and dim light on the anxiety of patient who are in the intensive care unit.

Detailed Description
-----------------
The primary endpoint is a numeric scale varying from 0 (no anxiety) to 10 (anxiety maximum).

Official Title
-----------------
Evaluation of a Comprehensive Approach in the Management of Anxiety in Intensive Care Unit Including Olfactotherapy

Conditions
-----------------
Anxiety

Intervention / Treatment
-----------------
* Other: ZEN cart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized in one of the departments participating in the study Presenting moderate to high intensity anxiety (Digital scale ≥ 5); Exclusion Criteria: Having already benefited from the ZEN cart Having taken an anxiolytic during the past 48 hours Patient (s) intubated and / or sedated Allergy or known intolerance to one of the essential oils used Respiratory allergies, asthma, or a history of seizures Unable to understand the information note (linguistic reason, or related to his medical condition) Pregnant or lactating woman.

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 |
| --- |
|Other: ZEN cart|essential oils + relaxing music + dim light|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measurement of the evolution of anxiety | The main objective of this study is to measure the evolution of the patient's anxiety between H0 (start of a ZEN cart session) and H6 (end of the ZEN cart session). | 6 hours |
Simulation Training as a Tool to Decrease Occupational Stress in ICU Personnel

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to check wether training mixed teams of physicians and nurses from intensive care units on patient simulators reduces stress in team members.

Detailed Description
-----------------
Patient safety and the prevention of medical error are primary goals of healthcare organizations. Stress reduction may reduce or ameliorate such errors. Simulation training, using advanced patient simulators, has been shown to improve diagnostic, resuscitation and technical skills amongst physicians and nurses.We intend to check wether stress during ICU shifts may be reduced by using specifically designed scenarios based on real life experience,in integrative multidisciplinary ICU teams.

Official Title
-----------------
Experimental Like Study of Stress Reduction in Intensive Care Teams by Use of Simulation Training

Conditions
-----------------
Education, Health

Intervention / Treatment
-----------------
* Behavioral: simulation training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: intensive care physicians and nurses working in respiratory ICU willing to participate in the study Exclusion Criteria: unwilling to participate
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Educational/Counseling/Training
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: simulation training|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction of stress parameters |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intensive care, stress, education, simulation
Haptic Devices Impact on Laparoscopic Simulators

Study Overview
=================
Brief Summary
-----------------
The study investigates the impact haptic devices have on reaching proficiency on a laparoscopic simulator as well as investigation if there is a difference in retention of the acquired skills.

Official Title
-----------------
Haptic Devices vs Non Haptic Devices - Results of a Randomized Trial

Conditions
-----------------
Medical Education

Intervention / Treatment
-----------------
* Other: Haptic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be a junior doctor working in a surgical department Exclusion Criteria: Having performed any laparoscopic surgeries as primary surgeon Lack of Basic Danish on a conversational basis
Sexes Eligible for Study
-----------------
All

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: Trainees/participants are randomized to either control or interventional group. After reaching proficiency participants must come back after 3-6 weeks to perform a retention test.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>In the intervention group trainees will train in an already validated laparoscopic training program with haptic devices. | Other: Haptic<br>* Trainees are randomized in this group to use the haptic device.<br>|
| No Intervention: Control<br>In the control group trainees will complete the same validated training program in the conventional non-haptic setting. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time (minutes) to reach the predefined proficiency level for the basic skills and salpingectomy procedure | Measured in minutes | From randomization till participants have passed all modules on the simulator (approx 3-4 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time (minutes) to reach the predefined proficiency level for the basic skills and salpingectomy procedure after 3-6 weeks without laparoscopic training on the non-haptic devices (retention test). | Measured in minutes | From randomization till participants passes all modules on the virtual reality simulator in the trial (approx. 3-4 weeks) |
Treatment Compliance in Children and Adolescents on ADHD Medication

Study Overview
=================
Brief Summary
-----------------
The primary research objective of this observational study is to evaluate treatment compliance over one year in children and adolescents who are newly initiated on medication approved for the treatment of ADHD in a routine clinical setting. Compliance will be assessed using the Pediatric Compliance Self-Rating (PCSR) Instrument. A patient will be considered as compliant at a given visit, if the PCSR score is at least 5, corresponding to taking the medication at least often.

Official Title
-----------------
Treatment Adherence and Compliance in Children and Adolescents on ADHD Medication and Emotional Expression in Clinical Practice

Conditions
-----------------
ADHD

Intervention / Treatment
-----------------
* Drug: Atomoxetine
* Drug: stimulants (any approved ADHD medication)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 6-17 years old diagnosis of ADHD according to ICD-10 or DSM-IV criteria new initiation onto an approved medication to treat ADHD Exclusion Criteria: no specific exclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 17 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 |
| --- | --- |
| A<br>A: ADHD-patients receiving non-stimulants (e.g. atomoxetine) | Drug: Atomoxetine<br>* in-label use<br>* Other names: Strattera;|
| B<br>B: ADHD-patients receiving stimulants | Drug: stimulants (any approved ADHD medication)<br>* in-label use<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Effectiveness of a Patient Self-reported Pain Scoring Tool and a Satisfaction Survey on Cancer Pain Management

Study Overview
=================
Brief Summary
-----------------
The purpose of this survey is to investigate the usefulness of a patient self-reported scoring tool on patient satisfaction improvement.

Official Title
-----------------
To Evaluate the Effectiveness of a Patient Self-reported Pain Scoring Tool and a Satisfaction Survey on Cancer Pain Management; Multicenter, Cross-sectional Study

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Behavioral: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have no experience with the study self-reported pain scoring tool Patients who are able to understand and answer the pain scoring tool questions Patients admitted to a hospital for more than 5 days due to cancer pain Patients for whom their pain managing physicians completed the medical staff's survey Exclusion Criteria: Patients who cannot answer the questions due to cognitive impairments

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 |
| --- | --- |
| Inpatients with cancer pain<br>Inpatients admitted for cancer pain management | Behavioral: No intervention<br>* This is an observational study with no investigational drug administered.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction with the control of cancer-related pain | Patients will answer on a 7-point scale how satisfied they feel about their cancer pain treatment. The scale scores range from 1 (not at all satisfied) to 7 (very much satisfied). | At baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient perception of pain | Patients will answer on an 11-point scale how much pain they feel. The scales scores range from 0 (no pain at all) to 10 (pain as bad as you can imagine). | At baseline | 
| Patient pain assessment by medical staff | The patient's physician will mark on an 11-point scale the intensity of the patient pain. The scale scores range from 0 (no pain at all) to 10 (pain as bad as you can imagine). | At baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain, Cancer pain, Self-reported pain scoring tool, Opioid analgesics
Peri-operative Vasopressor Support in Patients Operated for an Acute Hip Fracture (AHF)

Study Overview
=================
Brief Summary
-----------------
The incidence of hypotension perioperatively during operation of an acute hip fracture is unknown. As a surrogate factor the usage of vasopressor support is more adequate as the registration of vasopressor drugs are many times not complete in records. The investigators retrospectively investigated the anesthetic journals of 1100 patients with an acute hip fracture (AHF) noting confounding factors and the usage of vasopressors either by injections or infusions and then correlated these results to mortality at 30-, 90- and 365- days

Detailed Description
-----------------
The incidence of hypotension perioperatively during operation of an acute hip fracture is unknown. As a surrogate factor the usage of vasopressor support is more adequate as the registration of vasopressor drugs are many times not complete in records. The investigators retrospectively investigated the anesthetic journals of 1100 patients with an acute hip fracture (AHF) noting confounding factors and the usage of vasopressors either by injections or infusions and then correlated these results to mortality at 30-, 90- and 365-days Confounding factors were; all comorbitity, age, ASA grade as well as type of anesthesia

Official Title
-----------------
Peri-operative Vasopressor Support in Patients Operated for an Acute Hip Fracture (AHF)

Conditions
-----------------
Hip Fractures, Intraoperative Hypotension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients with an acute hip fracture Exclusion Criteria Only one fracture within time-limit. Unretreivable mortality data
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 |
| --- | --- | --- |
| Mortality |  | 365 days |
Damage and Renal Clearance of Glycocalyx in Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The glycocalyx is a component of the vascular endothelium that currently plays a relevant role in the modified Starling theory. The manipulation of the heart during cardiac surgery stimulates the release of the natriuretic atrial peptide, which causes endothelial wear in patients undergoing extracorporeal circulation. Dilation of the atrium produces natriuretic atrial peptide, which reduces plasma volume by increasing renal excretion and vascular permeability. The atrial peptide degrades the surface of the coronary endothelium, causing loss of the side cam protein nucleus. This study investigates the relationship between clamping time in cardiac surgery and the clearance of endothelial inflammation markers.

Official Title
-----------------
Damage and Renal Clearance of Glycocalyx in Cardiac Surgery

Conditions
-----------------
Glycocalyx, Cardio-Renal Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years of age Patients who underwent cardiac surgery for a single valve change or replacement Exclusion Criteria: Stage 3 renal failure patients Patients with a previous diagnosis of hematological malignancy Patients undergoing pulmonary valve change surgery. Patients undergoing Bentall and Bono surgery. Patients Undergoing Coronary Artery Bypass Surgery

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- | --- |
| Extracorporeal circulation time | Duration of Extracorporeal Circulation in minutes | 2 hours | 
| Aortic clamping time | Duration of aortic clamping time in minutes | 2 hours | 
| Hyaluronic acid levels in blood before surgery | Quantity of hyaluronic acid in blood before surgery | 30 minutes | 
| Hyaluronic acid levels in blood after surgery | Quantity of hyaluronic acid in blood after surgery | 30 minutes | 
| Hyaluronic acid levels in urine before surgery | Quantity of hyaluronic acid in urine before surgery | 30 minutes | 
| Hyaluronic acid levels in urine after surgery | Quantity of hyaluronic acid in urine before surgery | 30 minutes | 
| Sydecan -1 levels in blood before surgery | Quantity of Sydecan -1 in blood before surgery | 30 minutes | 
| Sydecan -1 levels in blood after surgery | Quantity of Sydecan -1 in blood after surgery | 30 minutes | 
| Sydecan -1 levels in urine before surgery | Quantity of Sydecan -1 in urine before surgery | 30 minutes | 
| Sydecan -1 levels in urine after surgery | Quantity of Sydecan -1 in urine after surgery | 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Renal clearance, Glycocalyx, Cardiac surgery