linjc16/ctgov huggingface dataset:
Comparative Effectiveness of Emergency Ultrasound Guided Management of Pediatric Soft Tissue Infections

Study Overview
=================
Brief Summary
-----------------
To examine the effect of Point-of-Care Ultrasound (POCUS) management guidance on pediatric skin and soft tissue infections treatment failure rate, as well as emergency department process outcome.

Official Title
-----------------
Comparative Effectiveness of Emergency Ultrasound Guided Management of Pediatric Soft Tissue Infections

Conditions
-----------------
Soft Tissue Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: history and examination findings consistent with possible abscess or cellulitis per the treating clinician. minimal lesion diameter for inclusion is 1cm. Exclusion Criteria: suspected soft tissue infections involving or near mucosal membranes (e.g. perirectal, peritonsillar, vulvovaginal areas) facial lesions paronychia or felon parent or patient refusal of consent unsuitable subjects deemed by treating clinicians.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 19 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 |
| --- | --- |
| Ultrasound<br>those who received point-of-care ultrasound as part of their emergency department evaluation/ treatment for suspected soft tissue infections | |
| No Ultrasound<br>those who did not receive point-of-care ultrasound as part of their emergency department evaluation/ treatment for suspected soft tissue infections | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment failure rate | unscheduled return visits need for subsequent procedural intervention need for subsequent admission change in therapy | 7-10days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| emergency department process outcome | emergency department (ED) length of stay, need for ED procedural sedation use of alternative imaging in ED | 7-10days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pediatric, soft tissue infections, ultrasonography, effectiveness
Flare Type Self-expandable Metal Stent for Malignant Colorectal Obstruction

Study Overview
=================
Brief Summary
-----------------
This study compares flare type self-expandable metal stent with conventional D-type self-expandable metal stent for malignant colorectal obstruction.

Official Title
-----------------
Comparison of Flare Type Self-expandable Metal Stent With Conventional D-type Self-expandable Metal Stent for Malignant Colorectal Obstruction

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Device: Flare type stent
* Device: Conventional D-type stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Malignant colorectal obstruction confirmed by radiologic study Exclusion Criteria: Bowel perforation Multiple obstruction Benign obstruction Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 90 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flare type stent<br>Flare type stent (Taewoong medical) has a wide diameter at proximal end to prevent stent migration. | Device: Flare type stent<br>* Flare type has a wide diameter at proximal portion to prevent stent migration.<br>|
| Active Comparator: Conventional D-type stent<br>Conventional D-type (Taewoong medical) stent has a same diameter at both ends. | Device: Conventional D-type stent<br>* This stent is an original full covered stent to treat malignant colorectal obstruction.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical success rate | Colon obstruction is relieved. | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colorectal cancer, stent
Breath Analysis in Healthy Controls

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to detect a specific profile of breath in healthy subjects by an untargeted metabolomic study using exhaled breath analysis by mass spectrometry.

Official Title
-----------------
Exhaled Breath Analysis by Secondary Electrospray Ionization (SESI-MS) in Healthy Controls

Conditions
-----------------
Exhaled Breath, Mass Spectrometry, Healthy Subjects

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal spirometry (forced expiratory volume in 1 second (FEV1) > 80%, forced vital capacity (FVC) > 80%, FEV1/FVC > 70%.). Age between 18 and 90 years at study entry. Exclusion Criteria: Presence of an active malignancy. Presence of any lung disease (e.g. asthma, chronic obstructive pulmonary disease (COPD), sarcoidosis) Acute inflammatory disease (e.g. common cold) within the last 6 weeks. Acute or chronic hepatic disease. Renal failure or renal replacement therapy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy<br>Healthy subjects with no apparent lung disease and normal lung function testing. | Other: No intervention<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome will be the mass spectrometric exhaled breath pattern of healthy subjects. |  | 1 day, single measurement, no follow up |
Perioperative Evaluation of Immuno-inflammatory Parameters

Study Overview
=================
Brief Summary
-----------------
This study consists of evaluations, using blood tests, various immune, inflammatory and coagulation parameters in the perioperative settings (different substudies), without changing anything to what is expected. This will allow us to clarify the possible impact of surgery and analgesia on perioperative activation of these pathways.

Detailed Description
-----------------
A significant number of published data can be concluded that surgery and anesthetic and analgesic techniques have an impact on immunity and inflammation. However, none of these studies have been performed with modern techniques, much more reliable evaluation of immune activity, such as the assessment of monocytic degranulation by flow cytometry. It is therefore important to document immune activity using these new techniques, our patients, perioperative. This will be analyzed, so observational, the potential impact of different therapeutic interventions the patient receives. This study consists of evaluations, using blood tests, various immune, inflammatory and coagulation parameters in the perioperative settings (different substudies), without changing anything to what is expected. This will allow us to clarify the possible impact of surgery and analgesia on perioperative activation of these pathways.

Official Title
-----------------
Perioperative Evaluation of Immuno-inflammatory Parameters

Conditions
-----------------
Combined Inflammatory and Immunologic Defect

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Surgical patients (and controls) Exclusion Criteria: Immune disorders

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 |
| --- | --- |
| Surgical cancer patients<br>No modification of the treatment | |
| Non-surgical cancer patients<br>No modification of the treatment | |
| Surgical non-cancer patients<br>No modification of the treatment | |
| Non-surgical non-cancer patients<br>No modification of the treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immune parameters (immunocytes phenotype) | Function tests and surface markers | baseline up to 8 days (return to baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term outcome | General morbidity and mortality | 5 years | 
| Coagulation parameters (like platelet function) (substudy) | Function tests and surface markers | perioperative period (up to 3 days) | 
| Inflammatory markers (cytokines) (substudy) | Intracellular FACS and ELISA measures | baseline up to 8 days (return to baseline) |
Comparing Intubation Rates in the Delivery Room by Interface

Study Overview
=================
Brief Summary
-----------------
Although the majority of premature neonates < 30 weeks gestion require positive pressure ventilation (PPV) at birth, the optimal interface to provide PPV has not been determined. Preferably this support would be provided by non-invasive means to prevent the development of bronchopulmonary dysplasia. Resuscitation with a face mask, single nasal tube, nasal prongs, and/or LMA are all approved methods of resuscitation per NRP as of 2010. Face masks have been associated with more dead space, air leak and airway obstruction however are the most commonly used interface. Recently, the Trigeminal Cardiac Reflex has been described, which can be induced with the placement of a facemask, resulting in bradycardia and apnea. Bi-nasal prongs (RAM cannula) have been found in studies to be associated with lower intubation rates in the delivery room (down to 24 weeks gestation), less need for epinephrine, chest compressions, and subsequent invasive ventilation. In addition to the potential practical advantages of bi-nasal prong resuscitation, there is evidence to suggest that ventilation through the nose may stimulate the subepithelial receptors of the upper airways causing an increase in respiratory rate and depth.

Official Title
-----------------
Comparing Intubation Rates in the Delivery Room by Interface

Conditions
-----------------
Ventilator Lung; Newborn

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All resuscitated infants < 30 weeks' gestation born at OSF SFMC Exclusion Criteria: Diagnosis of congenital diaphragmatic hernia No PPV needed, or no resuscitation desired due to major congenital anomalies or peri- viable status

Ages Eligible for Study
-----------------
Minimum Age: 0 Weeks
Maximum Age: 30 Weeks

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 |
| --- | --- | --- |
| Comparing Intubation Rates in the Delivery Room by Interface | We hypothesize that there will be at least a 40% reduction in the rate of intubation for patients born < 30 weeks' gestation when bi-nasal prongs are utilized for neonatal resuscitation vs face mask. | 3 years |
The Umbilical Access in Laparoscopic Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to access to the abdominal cavity using different incision-types within the umbilical area. Effects of different incisions on scarring and on the umbilical form will be investigated.

Official Title
-----------------
Comparative, Randomized, Open-label Study: Different Incisions to Access the Abdominal Cavity Within the Umbilicus

Conditions
-----------------
Scars, Patient Satisfaction, Cosmesis

Intervention / Treatment
-----------------
* Procedure: intraumbilical incision
* Procedure: infraumbilical incision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - patient undergoing laparoscopic surgery Exclusion Criteria: pregnancy patients following open abdominal surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: intraumbilical incision<br>an intraumbilical vertical incision is made | Procedure: intraumbilical incision<br>* vertical, intraumbilical incision<br>|
| Other: infraumbilical incision<br>incision is done in circular fashion at the inferior boarder of umbilicus | Procedure: infraumbilical incision<br>* incision at the inferior boarder of the umbilicus, circular<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scarring related to different accesses at the umbilicus | Appearance of scars will be assessed by means of the Manchester Scar Scale (MSS) | 3, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction with scars | Appearance of the umbilical postoperatively and patient satisfaction with the operative results will be assessed by means of a Body Image Questionnaire (BIQ) | 3, 12 months |
Along-term Study of OPC-262 in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical study is to evaluate the safety of OPC-262 (2.5 mg and 5 mg) in patients with type 2 diabetes by long-term administration orally for 52 weeks and to evaluate the efficacy of OPC-262

Official Title
-----------------
A Long-term Clinical Study of OPC-262 in Patients With Type 2 Diabetes on Study (Extension From Study 262-09-001)

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

Intervention / Treatment
-----------------
* Drug: OPC-262


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who completed Study 262-09-001 (namely, patients who visited the hospital at visit Week 24） Patients who are capable of giving informed consent prior to participating in this clinical study Patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner for the entire study period and for 4 weeks after the study (end of the post-observation period) Exclusion Criteria: Patients who withdrew from Study 262-09-001 Patients who experienced serious adverse events that the relationship with the study drug was not denied in Study 262-09-001 Patients who experienced serious adverse events that the relationship with the study drug are denied in Study 262-09-001 and whose symptoms are still emerged at the time of initiation of this study Patients who met the exclusion criteria of Study 262-09-001 during the study period of Study 262-09-001 Female patients who wish to become pregnant during the study period of Study 262-09-002 or within 4 weeks after the study Patients otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the study

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 74 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: OPC-262<br> | Drug: OPC-262<br>* Orally administered once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HBA1c form baseline |  | 52 Weeks | 
| Incidence and severity of adverse events |  | 52 Weeks |
Health Group Intervention Among Refugees in Sweden

Study Overview
=================
Brief Summary
-----------------
This prospective intervention study evaluates whether health education and basic body awareness training reduces health care consumption and improves movement quality among refugees in Sweden.

Detailed Description
-----------------
Migration is well known to be stressful and to have a negative impact on Health. Multidisciplinary health-promoting group interventions have significantly improved self-rated health. Further, symptom improvement was shown after implementation of physical activity in form of basic body awareness training. In this study a multimodal team consisted of a physiotherapist, nurse, psychologist, dietician, and physician held sessions of three hours weekly for a period of nine weeks. The sessions started with basic body awareness training, followed by theme discussions on symptoms and health strategies. A total of 54 participants completed the intervention. Health care consumption and movement quality were measured before and after the intervention.

Official Title
-----------------
Health Group Intervention Among Refugees in Sweden

Conditions
-----------------
Migration Stress

Intervention / Treatment
-----------------
* Behavioral: health education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Refugees seeking primary care consultation or rehabilitation unit aged 18-65 years were candidates for inclusion. Based on the health care provider's assessment, patients whose health symptoms could be connected to or increased by the migration process were eligible for inclusion - Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: baseline and follow up in one population
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Health education<br>Assessment of healt care Contacts Before and after intervention | Behavioral: health education<br>* Health information by a multimodal team<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health care consumption | number of Health care contacts | three months before and after intervention |
Does the Message Matter? Enhancing Adherence in Healthcare Through Persuasive Messages

Study Overview
=================
Brief Summary
-----------------
In this research we propose to develop a comprehensive model to explain how users process persuasive messages. We then propose to experimentally test varying the persuasiveness of message content in various domains, and assess their impact on adherence by both physicians and patients. Finally based on our conceptual model and results from the experimental data we propose to develop preliminary guidelines to assist developers in designing effective messages.

Official Title
-----------------
Does the Message Matter? Enhancing Adherence in Healthcare Through Persuasive Messages

Conditions
-----------------
Appointment Reminders

Intervention / Treatment
-----------------
* Behavioral: Electronic reminder message


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Study 1 1. Subjects who have an appointment scheduled at HCHD Baytown Health Center Study 2 Subjects who are neonatology physicians (not in training). Subjects must be able to give signed informed consent. Study 3 Any subjects (students or employee) at the University of Texas Health Science Center at Houston. Subjects must be able to give signed informed consent. Exclusion Criteria: No specific individual who meets the inclusion criteria will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Electronic reminder message|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Clinical Trial Assessing Two Protocols to Withdraw Non-invasive Ventilation in Hypercapnic Respiratory Failure

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the optimal method to withdraw non-invasive ventilation after an episode of hypercapnic respiratory failure.

Official Title
-----------------
A Randomized Controlled Trial Comparing Two Protocols to Withdraw Non-invasive Ventilation (NIV) After an Episode of Hypercapnic Respiratory Failure

Conditions
-----------------
Hypercapnic Respiratory Failure

Intervention / Treatment
-----------------
* Device: Nocturnal non-invasive ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute hypercapnic respiratory failure. Use of NIV to treat respiratory failure. Persistence of hypercapnia after discontinuation of NIV Exclusion Criteria: Home NIV Facial or cranial trauma or surgery, Recent gastric or esophageal surgery, Active upper gastrointestinal bleeding, Excessive amount of respiratory secretions, Tracheostomy Lack of cooperation
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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Non-invasive ventilation is maintained during three nights after recovery of an episode of hypercapnic respiratory failure. | Device: Nocturnal non-invasive ventilation<br>* Prolongation of non-invasive ventilation during 3 nights.<br>|
| No Intervention: 2<br>Discontinuation of NIV after the recovery of hypercapnic respiratory failure, without prolong it during night. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New episode of hypercapnic respiratory failure after discontinuation of non-invasive ventilation |  | At the end of enrollment time | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of long term dependency on non-invasive ventilation |  | At the end of enrollment time | 
| Hospital and 6-month survival |  | At the end of enrollment time |