linjc16/ctgov huggingface dataset:
Pilot Study Evaluating Stress Response and Immune Function in Mechanically Ventilated Patients With Alcohol Use Disorders Treated With Propofol or Midazolam

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the effects of the sedatives propofol and midazolam on stress response and immune function in critically ill patients with alcohol use disorders who are undergoing mechanical ventilation.

Detailed Description
-----------------
No detailed description

Official Title
-----------------
Randomized Clinical Trial Comparing Propofol and Midazolam in Mechanically Ventilated Critically Ill Patients With Alcohol Use Disorders: An Open Label Pilot Study

Conditions
-----------------
Alcoholism, Respiration, Artificial

Intervention / Treatment
-----------------
* Drug: Propofol
* Drug: Midazolam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of alcohol use disorders Need for invasive mechanical ventilation Need for continuous intravenous infusion of sedative(s) Exclusion Criteria: Age < 18 years Pregnant women Prisoners Receiving propofol prior to randomization Patient experiencing active alcohol withdrawal Immunosuppression Shock Attending physician does not feel patient is candidate to receive either propofol or midazolam Patient has contraindication(s) to receiving either propofol or midazolam Inability to enroll patient within 96 hours after initiation of mechanical ventilation Transfer from another intensive care unit

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propofol<br>Patients to be sedated for up to 72 hours with study drug propofol | Drug: Propofol<br>* Patients to be sedated for up to 72 hours with study drug propofol<br>|
| Experimental: Midazolam<br>Patients to be sedated for up to 72 hours with study drug midazolam | Drug: Midazolam<br>* Patients to be sedated for up to 72 hours with study drug midazolam<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stress response and immune function. |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alcoholism, Mechanical ventilation
Application of Early Physical Therapy Regimens in Patients With Veno-venos Extracorporeal Membrane Oxygenation

Study Overview
=================
Brief Summary
-----------------
Promote early recovery through the application of early physiotherapy programs for VV-ECMO patients

Detailed Description
-----------------
This study is intended to construct early physiotherapy programs for VV-ECMO patients, including multidisciplinary team building, safety assessment, early active physiotherapy, respiratory physiotherapy, with a view to promoting early recovery of patients, early withdrawal of ventilator-assisted ventilation, shortening ECMO auxiliary time, improving patients' exercise level and respiratory function, reducing complications, and improving the quality of near-term and long-term survival.

Official Title
-----------------
Application of Early Physical Therapy Regimens in Patients With Veno-venos Extracorporeal Membrane Oxygenation

Conditions
-----------------
Extracorporeal Membrane Oxygenation Complication

Intervention / Treatment
-----------------
* Behavioral: early physiotherapy programs
* Behavioral: routine treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: VV-ECMO assisted support lung failure (e.g. ARDS) age ≥18 years sober informed consent to this study Exclusion Criteria: unstable blood flow mechanics active bleeding mental disorders that do not work together people waiting for lung transplants people at the end of life (e.g. advanced lung cancer)

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: Supportive Care
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Non-contemporaneous control
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: routine treatment<br>Review the collection of patient-related clinical data, collation of clinical data and outcome indicators | Behavioral: routine treatment<br>* provide routine nursing and rehabilitation program<br>|
| Experimental: Experimental group<br>Implement early physiotherapy programs. The early physiotherapy program for VV-ECMO patients mainly includes the establishment of multidisciplinary teams, safety assessment, early activity physiotherapy and respiratory physiotherapy. | Behavioral: early physiotherapy programs<br>* establishment of multidisciplinary teams, safety assessment, early activity physiotherapy and respiratory physiotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VV-ECMO auxiliary time | the time for VV-ECMO auxiliary | 1 year |
Kagoshima Collaborate Trial in Metabolic Syndrome (KACT Study)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to consider the following points in patients with hypertension who complicated by metabolic syndrome for Valsartan basis treatment and an existing, standard treatment. Blood pressure control Changing of adiponectin and plasminogen activator inhibitor-1 Influence metabolizing and cardiac function, etc.

Detailed Description
-----------------
The primary endpoints are: blood pressure control Adiponectin and plasma type1 plasminogen active inhibitor The secondary endpoints are HOMA-IR HbA1c TNF-α IL-6 Plasma B-type natriuretic peptide LVMI E/A ratio Tei-index Apo-J

Official Title
-----------------
Effects of Valsartan on Metabolic Syndrome in Patients With Hypertension

Conditions
-----------------
Hypertension, Obesity

Intervention / Treatment
-----------------
* Drug: Valsartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Out patients with hypertension male and female Systolic blood pressure (SBP)≧140mmHg and/or diastolic blood pressure (DBP)≧90 mmHg Waist Surrounding diameter male≧85cm female≧90cm Patient who is treating either high triglyceride,low HDL,or diabetes mellitus Patient who is untreatment high triglyceride blood syndrome and low HDL blood syndrome,diabetes mellitus is triglceride≧150mg/dl and/or HDL cholesterol < 40 mg/dl or fasting blood glucose ≧110 mg/dl Untreated patients with hypertension,or patients is treated with antihypertensive agents except for ACE-I and ARB Exclusion Criteria: Patient who is using ACE-I and ARB Serum creatinine ≧ 3 mg/dl Liver impairment History of allergy to valsartan Pregnant women Judgment by the physician that participation was unwise on the basis of patient characteristics and drug safety
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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Valsartan<br>Valsartan 80 to 160mg | Drug: Valsartan<br>* Valsartan 80 to 160 mg<br>|
| No Intervention: standard therapy<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure, Adiponectin and PAI-1 concentration |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HOMA-IR |  | 1 year | 
| HbA1c |  | 1 year | 
| TNF-α |  | １ year | 
| IL-6 |  | 1 year | 
| BNP |  | 1 year | 
| LVMI |  | 1 year | 
| E/A ratio |  | 1 year | 
| Tei-index |  | 1 year | 
| Apo-J |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
valsartan, Metabolic syndrome
Validation Study of G4 User Interface

Study Overview
=================
Brief Summary
-----------------
The purpose of this simulated useability study is to demonstrate the user interface and software design mitigate potential safety concerns.

Detailed Description
-----------------
These are the detailed descriptive planned outcomes of this useability study. To demonstrate that human-interface design mitigations lead to effective, efficient, and safe use. Validate that foreseeable misuse does not lead to a safety hazard or patient injury. Validate the effectiveness and comprehension of critical warnings and alerts, including vibratory, auditory, and textual cues.

Official Title
-----------------
Simulated Usability Trial of the T-Slim Ambulatory Insulin Infusion Pump

Conditions
-----------------
Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of diabetes mellitus

Ages Eligible for Study
-----------------
Minimum Age: 22 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 |
| --- | --- | --- |
Retrospective Evaluation of Erector Spinae Plane Blocks

Study Overview
=================
Brief Summary
-----------------
Retrospective Evaluation of Erector Spinae Plane Blocks

Detailed Description
-----------------
in our institue; we use erector spinae plane block as a part of multimodal analjesia. we want to evaluate block failures and complications related erector spinae plane block. In all patients performed regional anesthesia techniques, we use a regional anesthesia follow chart.

Official Title
-----------------
Evaluation of Erector Spinae Plane Block; Indications, Complications and Analgesic Effects

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

Intervention / Treatment
-----------------
* Procedure: erector spinae plane block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient performed erector spinae plane block Exclusion Criteria: -

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: erector spinae plane block|unilateral or bilateral or bilevel erector spinae plane block performance for postoperative pain or acute pain|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complication rate |  | 14 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| block failure rate |  | 14 months |
New Criteria for Accessory Pathway Localization From Surface ECG

Study Overview
=================
Brief Summary
-----------------
study for discovering new criteria for localization of site of accessory pathway from surface ECG

Detailed Description
-----------------
the study aims for discovering new criteria for percise localization of accessory pathway from surface ECG in referance to final flouroscopic ablation site

Official Title
-----------------
Studying New Criteria for Prediction of Site of Accessory Pathway From Surface ECG

Conditions
-----------------
Accessory Pathway

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any patient with manifest accessory pathway . Exclusion Criteria: multiple accessory pathways .previous ablation.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 90 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percise localization of accessory pathway from surface ECG in referance to successful ablation site | successful localization of accessory pathway from surface ECG in referance to successful ablation site during EP maping | 2 years |
Defining the Serum Ferritin Concentration in Kenyan Women at Which the Body Senses Iron Depletion and Begins to Upregulate Iron Absorption

Study Overview
=================
Brief Summary
-----------------
The serum or plasma ferritin concentration (referred to hereafter as ferritin) is the most widely used indicator to detect iron deficiency and a low ferritin indicates depleted iron stores. However, the threshold ferritin that defines iron deficiency remains unclear and diagnostic ferritin cutoffs from expert groups vary widely. Our study aim is to define the ferritin in Kenyan young women at which the body senses iron depletion and begins to upregulate iron absorption from the diet; this approach could provide a functionally defined threshold of iron deficiency in Sub-Saharan African women.

Official Title
-----------------
Defining the Serum Ferritin Concentration in Kenyan Women at Which the Body Senses Iron Depletion and Begins to Upregulate Iron Absorption

Conditions
-----------------
Iron-deficiency, Ferritin Threshold, Iron Absorption, Stable Iron Isotopes

Intervention / Treatment
-----------------
* Other: Isotopically labelled iron sulfate 15mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-28 y, not pregnant or lactating Body weight <75 kg body mass index (BMI) between 17 and 25 kg/m2 No acute illness/infection (self-reported) No metabolic or gastrointestinal disorders (self-reported) No use of medications affecting iron absorption or metabolism during the study No intake of mineral/vitamin supplements 2 weeks prior to the first study visit and during the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 28 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Isotopically labelled iron sulfate 15mg<br> | Other: Isotopically labelled iron sulfate 15mg<br>* test drink: water containing isotopic iron solution with vitamin C<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fractional iron absorption | shift in iron isotopic ratios measured in red blood cells | Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Ferritin |  | Day 0 | 
| soluble transferrin receptor |  | Day 0 | 
| C-reactive protein |  | Day 0 | 
| alpha-1-glycoprotein |  | Day 0 | 
| Hemoglobin |  | Day 0 | 
| Plasma Hepcidin |  | Day 0 |
Individual Patient Compassionate Use of GX-I7

Study Overview
=================
Brief Summary
-----------------
Compassionate use of GX-I7 for patients with serious life-threatening illness that have exhausted all available therapies, with no other therapy options.

Detailed Description
-----------------
This program is being offered on a patient by patient basis and will require company, Institutional Review Board/Independent Ethics Committee and Single Patient IND approval.

Official Title
-----------------
Individual Patient Compassionate Use of GX-I7

Conditions
-----------------
Glioblastoma, High Grade Glioma, Recurrent Glioblastoma, Melanoma, Advanced Cancer

Intervention / Treatment
-----------------
* Drug: GX-I7


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: -

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GX-I7|patients will receive the assigned dose of GX-I7 intramuscular injection every 4 12 weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Trial Using Integuseal as Microbial Sealant for Arterial Bypass Surgery on Lower Extremities

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to prove a reduction of postoperative wound infections after direct preoperative use of a microbial sealant in the form of Integuseal for vascular procedures on lower extremities.

Official Title
-----------------
Prospective Randomised Trial Using Integuseal as Microbial Sealant for Arterial Bypass Surgery on Lower Extremities

Conditions
-----------------
Arterial Obstructive Diseases

Intervention / Treatment
-----------------
* Procedure: Application of Integuseal sealant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: planned supragenual of infragenual peripheral arterial bypass procedures with autologue or prosthetic graft Exclusion Criteria: secondary procedures and suprainguinal procedures

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 |
| --- | --- |
| No Intervention: No use of integuseal<br> | |
| Experimental: Use of Integuseal<br>Application of a layer of Integuseal (Cyanoacrylate) from a ready to use applicator preoperative before incision Polymerisation immobilise the bacteria that survived the conventional skin preparation This way there will be les contamination of the wound. | Procedure: Application of Integuseal sealant<br>* Microbial sealant (integuseal) applied with a sponge applicator<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative wound infections |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Costs of the use of Integuseal |  |  | 
| Complications during hospital stay |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Integuseal microbial sealant, Infection prophylaxis, Postoperative wound infection, Arterial bypass surgery
Levetiracetam Treatment of Children With Subclinical Sleep-Activated Epileptiform Activity (SSEA)

Study Overview
=================
Brief Summary
-----------------
In clinical practice at the National centre for epilepsy (SSE) in Norway we see many children who have subclinical epileptiform activity in EEG that increases substantially during slow wave sleep (SSEA; subclinical sleep-activated epileptiform activity). They may or may not have seizures. Hence, according to the definition some children with SSEA do not suffer from epilepsy because they do not experience seizures. Many of these children have symptoms such as: attention deficit hyperactivity disorders (AD/HD), dyslectic problems, sleep problems, tantrums or autistic symptoms . We hypothesize that this subclinical epileptiform activity during slow sleep may act negatively on cognitive functions, language and behaviour in some children; even when the spike-wave discharges are less frequent than in CSWS (continuous spike-waves during slow sleep).

Official Title
-----------------
Levetiracetam Treatment of Children With Subclinical Sleep-Activated Epileptiform Activity (SSEA) - a Placebo Controlled Double-blind Cross-over-study

Conditions
-----------------
Subclinical Sleep-Activated Epileptiform Activity, CSWS

Intervention / Treatment
-----------------
* Drug: levetiracetam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children 5-10 years IQ > 50

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 10 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: levetiracetam|20 mg pr. kg a day|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hour EEG |  | End of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuro-psychological testing, |  | End of the study | 
| Health related quality of life |  | End of the study | 
| Behavioral problems |  | End of the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CSWS, interiktal epileptiform activity