linjc16/ctgov huggingface dataset:
Prevention of IPH: Electric Warming Mattress vs Forced Air Warming Blanket

Study Overview
=================
Brief Summary
-----------------
This study will determine if modern under-patient warming mattresses are as effective as forced air warming blankets in preventing cold and shivering in patients scheduled for non emergency surgery.

Official Title
-----------------
A Study to Determine if Modern Under-patient Warming Mattresses Are as Effective as Forced-air Warming Blankets in Preventing Peri-operative Hypothermia

Conditions
-----------------
Inadvertent Perioperative Hypothermia, Patient Warming

Intervention / Treatment
-----------------
* Other: warming mattress
* Other: warming blanket


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing elective (non emergency) surgery who will require intra-operative warming Patients whose surgery will be performed with them in the supine position Exclusion Criteria: Abdominal aortic aneurysm repair All adults (over 18 years) who refuse,who are unable to fully understand the trial ALL laparoscopic surgeries

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: warming mattress<br>Patient warmed with electric mattress | Other: warming mattress<br>* comparison of under patient warming mattress to forced air warming blankets in preventing peri-operative hypothermia<br>* Other names: Inditherm electric carbon polymer warming mattress;|
| Active Comparator: warming blanket<br>Forced air warming blanket | Other: warming blanket<br> <br> * Other names: Bair hugger;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative core temperature greater than or equal to 36 degrees centigrade. This is a surrogate marker for complications such as reduced wound infection and reduced hospital stay that have been previously established by other research. |  | 15minutes to 2 hours approximately postoperatively in recovery room | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| shivering |  | up to 2h post op (time in recovery) | 
| Core temperature |  | From induction of anaesthesia to arrival in recovery |
Length of Post Operative Dressing After Carpal Tunnel Release

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to prospectively compare the functional, satisfaction, and wound outcomes of patients treated with one of two accepted methods of postoperative dressing following carpal tunnel release. Hypothesis: There will be no difference between the short term (approximately 2 - 3 days)and longer term (9 to 14 days)bulky dressing groups in terms of outcomes.

Official Title
-----------------
Length of Postoperative Dressing After Mini-open Carpal Tunnel Release: A Randomized Prospective Comparison

Conditions
-----------------
Carpal Tunnel Syndrome

Intervention / Treatment
-----------------
* Other: extended postoperative dressing
* Other: short postoperative dressing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults carpal tunnel syndrome Exclusion Criteria: previous surgery for Carpal Tunnel Syndrome ipsilateral hand, arm, shoulder surgery with continued symptoms

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: extended postoperative dressing<br>Bulky dressing for 2 weeks | Other: extended postoperative dressing<br>* 2 weeks of bulky dressing<br>|
| Other: short postoperative dressing<br>2 day bulky dressing followed by bandaid. | Other: short postoperative dressing<br>* 2 days bulky dressing followed by bandaid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Levine-Katz Scale assessed at different time points. | Symptom and function of Carpal Tunnel Syndrome | Levine-Katz Scale at baseline (pre-operation) | 
| Change in the Levine-Katz Scale from baseline(pre-operation) at 2 weeks | Symptom and Function of Carpal Tunnel Syndrome | Baseline and two weeks. | 
| Change in the Levine-Katz Scale from baseline(pre-operation) at 3 months | Symptom and function of Carpal Tunnel Syndrome | Baseline and three months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
orthopedics, carpal tunnel syndrome, postoperative care
Opposition to Diagnostic or Therapeutic Procedures by Aged Hospitalized Patient

Study Overview
=================
Brief Summary
-----------------
The main object is to identify and understand why some hospitalized aged patients oppose himself to treatment or diagnosis procedure. This mixed study will used a census in a geriatrics department and a qualitative research.

Detailed Description
-----------------
To complete qualitative study, interview will also be conducted with : patients, general practitioner, relative and home carers. An observation of geriatric multidisciplinary staff will be done for better understanding of complexity.

Official Title
-----------------
Opposition to Diagnostic or Therapeutic Procedures by Aged Hospitalized Patient on Geriatrics Department.

Conditions
-----------------
Qualitative Research, Epidemiology, Aging, Refusal, Treatment

Intervention / Treatment
-----------------
* Other: Census


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: geriatric department inpatient. presenting opposition to medical or diagnosis procedure covered by French Social Security System agreed to participate to the study Exclusion Criteria: They did not express himself an opposition They disagree to participated For qualitative research only : major neurocognitive disorder (MMSE <10).

Ages Eligible for Study
-----------------
Minimum Age: 75 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 |
| --- | --- |
| Census<br>Epidemiological study. Sociodemographic and medical survey. | Other: Census<br>* Survey and interview<br>* Other names: Qualitative study;|
| Qualitative interview<br>Individual qualitative interview. | Other: Census<br>* Survey and interview<br>* Other names: Qualitative study;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30 individual semi-structured interviews | Qualitative data analysis and theorical saturation | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 100 demographic survey | Statistical analysis | 1 year | 
| 100 medical survey | Statistical analysis | 1 year |
Carotid and Vertebral Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)

Study Overview
=================
Brief Summary
-----------------
The study will evaluate the efficacy and safety of Dotarem enhanced MRA in patients suffering from carotid or vertebral arterial disease.

Detailed Description
-----------------
Each subject will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem enhanced MRA.

Official Title
-----------------
Evaluation of Dotarem-enhanced MRA Compared to Time-Of-Flight (TOF) MRA in the Diagnosis of Carotid and Vertebral Basilar Arterial Disease

Conditions
-----------------
Cerebral Arterial Diseases

Intervention / Treatment
-----------------
* Drug: Dotarem
* Other: TOF MRA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, aged more than 18 years Strongly suspected of having carotid or vertebral arterial disease Scheduled (or to be scheduled) to undergo computed tomography angiography (CTA) examination Exclusion Criteria: Known grade IV or V chronic kidney disease (GFR<30 mL/min/1.73m²) Contraindication to MRI Acute renal dysfunction within the 6 months preceding Dotarem®-enhanced MRA examination

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dotarem and TOF MRA<br>Each subject will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem enhanced MRA. | Drug: Dotarem<br>* Each subject will receive one injection of Dotarem 0.2ml/kg<br>* Other names: Gadoterate meglumine;Other: TOF MRA<br>* Each subject will undergo a Time of Flight Magnetic Resonance Angiography (TOF MRA)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Failure Rate | Rate of non-assessable arterial segments as measured by 3 independent readers in off-site evaluation of TOF-MRA and Dotarem-enhanced MRA (re-read DGD-44-060). | 2 - 28 days | 
| Sensitivity | Rate of true stenotic segments (i.e. with stenosis >= 70%) of TOF and Dotarem-enhanced MRA evaluated by 3 independent off-site readers at the segment level, with CTA as standard of truth (re-read DGD-44-060). | 2-42 days | 
| Specificity | Rate of true non-stenotic segments (i.e. without stenosis >= 70%) of TOF and Dotarem-enhanced MRA evaluated by 3 independent off-site readers at the segment level, with CTA as standard of truth (re-read DGD-44-060). | 2 - 42 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRA, carotid or vertebral artery disease, Contrast agent
Engorgement Study With a Double Electric Breast Pump

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to analyze the effectiveness of an FDA approved Class II medical device, the Simplisse Double Electric Breast Pump, in relieving the symptoms of engorgement.

Official Title
-----------------
Engorgement Study With the Simplisse Double Electric Breast Pump

Conditions
-----------------
Engorgement

Intervention / Treatment
-----------------
* Device: Simplisse Double Electric Breast Pump


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: first week postpartum seeking lactation management assistance for engorgement, identified as clinically engorged by health care practitioner. Exclusion Criteria: greater than one week postpartum less than 18 years of age non-English speakers not willing to use double electric breast pump

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lactating women<br>Lactating women willing to use a breast pump. | Device: Simplisse Double Electric Breast Pump<br>* Use of breast pump for 10 minutes.<br>* Other names: Simplisse Double Electric Breast Pump, 1005S;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Engorgement Relief | Relief of engorgement as measured by the engorgement scale. | 10 minutes per subject | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast pump, engorgement, lactation
MEOI and HRQoL in CLL Patients Treated With BTKis

Study Overview
=================
Brief Summary
-----------------
This is a multi-site observational study of medical events of interest (MEOI) and health-related quality of life (HRQoL) in chronic lymphocytic leukemia (CLL) patients initiating treatment with the Bruton's tyrosine kinase inhibitors (BTKi) acalabrutinib or ibrutinib in the United States (US)

Official Title
-----------------
Medical Events of Interest and Health-Related Quality of Life in Chronic Lymphocytic Leukemia Patients Initiating Treatment With Bruton's Tyrosine Kinase Inhibitors Acalabrutinib or Ibrutinib

Conditions
-----------------
Chronic Lymphocytic Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18 years old Physician-confirmed diagnosis of CLL or small lymphocytic lymphoma (SLL) BTKi naïve patients who initiate acalabrutinib or ibrutinib treatment alone or in combination with an anti-CD20 mAb within 7 days (before or after) study enrollment*. Both treatment naïve and relapsed/refractory CLL patients will be included. Provides informed consent Adequate English reading skills Able to access and use a computer, tablet, or smartphone to complete PROs Exclusion Criteria: Use of BTKi any time prior to study enrollment. Currently receiving systemic treatment for another malignancy Currently enrolled in a clinical trial
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acalabrutinib<br>CLL patients initiating acalabrutinib alone or in combination with an anti-CD20 mAb | |
| Ibrutinib<br>CLL patients receiving ibrutinib alone or in combination with an anti-CD20 mAb | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Characteristics | To describe the demographic and clinical characteristics of CLL patients who have recently initiated acalabrutinib or ibrutinib. | Baseline | 
| Chart Recorded Medical Events of Interest | To describe MEOI experienced by CLL patients who have recently initiated acalabrutinib or ibrutinib using medical chart abstracted data, over a 24-month period | 24 Month Follow-up | 
| Patient Reported Medical Events of Interest | To describe MEOI experienced by CLL patients who have recently initiated acalabrutinib or ibrutinib using patient reported data, over a 24-month period. | 24 month follow-up | 
| HRQoL | To describe HRQoL for CLL patients who recently initiated acalabrutinib or ibrutinib using patient reported data, over a 24-month period | 24 month follow-up |
Hemodynamic Response to Intubation

Study Overview
=================
Brief Summary
-----------------
This study investigates the effects of dexmedetomidine and esmolol given intravenously before intubation on sympathetic response caused by intubation itself. Half the patients will recevice dexmedetomidine and the other half will receive dexmedetomidine. Ischemia modified albumine levels will be measured

Official Title
-----------------
The Effects of Preintubation Esmolol and and Dexmedotimidine on Ischmeia Modified Albumin Levels

Conditions
-----------------
Intubation

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine
* Drug: Esmolol
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing elective surgery under general anesthesia Exclusion Criteria: Patient refusal Morbid obesity (BMI>30) Advanced systemic disease Hypoalbumiemia beta-blocker usage Anticipated difficult ventilation and/or intubation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dexmedetomidine<br>0.5 mcg/kg dexmedetomidine in 20 ml normal saline will be infused in 5 minutes before intubation | Drug: Dexmedetomidine<br> <br> |
| Experimental: Esmolol<br>0.5 mg/kg esmolol in 20 ml normal saline will be infused in 5 minutes before intubation | Drug: Esmolol<br> <br> |
| Placebo Comparator: Placebo<br>20 ml normal saline infused in 5 minutes before intubation | Drug: Placebo<br>* normal saline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ischemia modified albumine | ischemia modified albumine levels will be measured as a response to intubation | 10 minutes after endotracheal intubation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intubation, ischemia modified albumine, dexmedetomidine, esmolol
Prevention Through Intervention: Telehealth Solution to Deter 911 Calls Due to Hypoglycemia

Study Overview
=================
Brief Summary
-----------------
This study aims to standardize and evaluate the benefits of the Prevention to Intervention program offered by the Birmingham Fire and Rescue Service. This will accomplished by standardizing the educational materials used, offering phone based follow-up and pre-post data collection.

Official Title
-----------------
Prevention Through Intervention: Telehealth Solution to Deter 911 Calls Due to Hypoglycemia

Conditions
-----------------
Diabetes Mellitus, Hypoglycemia, Hypoglycemia Unawareness, Hypoglycemia Acute

Intervention / Treatment
-----------------
* Behavioral: Hypoglycemia Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be a citizen of Birmingham Be 18 years or older Receive Dextrose-50 IV (intravenous treatment provided by EMS personnel for hypoglycemia) Understand and speak English Exclusion Criteria: a) Enrolled currently in any diabetes related educational programs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm pre-post study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br>Hypoglycemia Education: Participants will receive educational support to prevent repeat episodes of hypoglycemia. | Behavioral: Hypoglycemia Education<br>* Two in-person visits to the home of the participant and 4 phone calls will be conducted to provided education on prevention of hypoglycemia.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fear of Hypoglycemia | One of the most important impact of hypoglycemia, is non-compliance to diabetes treatment due to the fear of hypoglycemia. This would be measured using the Hypoglycemia Scale: FH-15 scale. | Through study completion, an average of 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self Efficacy | Measured using the Perceived Diabetes Self-Management Scale. | Pre and Post (after 8 weeks)Through study completion, an average of 8 weeks | 
| Knowledge of Diabetes | Measured using the The Knowledge in Low Literacy in Diabetes Knowledge Assessment Scale | Through study completion, an average of 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Telehealth, Emergency Medicine, Paramedicine, Diabetes, Hypoglycemia, Telecoaching
Balance Study on ICU-acquired Hypernatremia and Sodium Handling (BIAS)

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to find differences between patients who do and do not develop ICU-acquired hypernatremia (IAH). Therefore extended sodium and fluid balances will be performed. Also a couple of other factors that possibly contribute to the development of IAH and/or could give clues about the mechanisms in the development of IAH will be investigated.

Detailed Description
-----------------
ICU-acquired hypernatremia (IAH) is common in critically ill patients, but it's aetiology is still not fully understood. Sodium overload and inadequate fluid administration are generally considered important factors, but a previous retrospective study did not reveal differences in sodium or fluid balances between patients who did and did not develop IAH. Because this was retrospective these balances will be prospectively studied in this study to be more sure about the importances of these balances in the development of IAH. Previous studies indicated that (a lot) more factors contribute to the development of IAH. In this study these factors will be investigated, hoping to find differences between patients who do and do not develop IAH.

Official Title
-----------------
Balance Study on ICU-acquired Hypernatremia and Sodium Handling

Conditions
-----------------
ICU-acquired Hypernatremia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Predicted duration of ICU-admission >48 hours Exclusion Criteria: Renal replacement therapy Reason for admission necessitates actively elevation of serum sodium concentration Electrolyte disturbance as reason for admission ICU re-admission within 30 days Referral from another ICU Serum sodium concentration on admission 143mmol/l or above

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 |
| --- | --- | --- |
| Sodium balance | Differences in sodium balances between patients who do and do not develop IAH | During ICU-admission | 
| Fluid balance | Differences in fluid balances between patients who do and do not develop IAH | During ICU-admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kidney function | Differences in parameters concerning kidney function (creatinine, urea) between patients who do and do not develop IAH | During ICU-admission | 
| Inflammation | Differences in inflammation (CRP, infections) between patients who do and do not develop IAH | During ICU-admission | 
| Nutritional state | Differences in nutritional state (albumin, BIVA-measurement) between patients who do and do not develop IAH | During ICU-admission | 

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