linjc16/ctgov huggingface dataset:
Teaching Children With Asthma and Who Live in a Rural Setting How to Self-Manage Their Asthma

Study Overview
=================
Brief Summary
-----------------
To determine if teaching rural children with asthma and their parents about appropriate medication use, asthma triggers unique to a rural setting and increasing access to medical care will result in a decrease in emergency department visits.

Detailed Description
-----------------
Many self-management asthma interventions have demonstrated increase in asthma knowledge, reduced emergency department visits, increased self-efficacy and quality of life. The type of self-management interventions, specifically individualized and interactive educational interventions, have been suggested to have the strongest effect on asthma morbidity. Few studies have tested asthma self-management educational interventions in increasing knowledge, self-efficacy and quality of life in rural pediatric populations. The goal of this study was to test the effectiveness of an asthma educational intervention in improving asthma knowledge in rural children and their parent/caregivers. We hypothesized that an interactive asthma educational intervention would increase parent/caregiver and child asthma knowledge resulting in decreased emergency room visits in rural families of children with asthma.

Official Title
-----------------
A+ Asthma Rural Partnership

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Behavioral: Nurse asthma education intervention
* Behavioral: Control Group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Physician diagnosed asthma, attend elementary school in rural county agreeing to participate Exclusion Criteria: Participation in another asthma study or having other respiratory illness such as cystic fibrosis, BPD -

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 12 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Behavioral: Nurse asthma education intervention<br>* Asthma Education<br>|
| Other: 2<br> | Behavioral: Control Group<br>* Asthma Education<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in emergency department visits |  | 10 months or 1 school year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma Education |  | 10 months or 1 school year |
Volontary Inspiratory Muscles Measures Compared With Phrenic Nerves Magnetic Stimulations Measures

Study Overview
=================
Brief Summary
-----------------
Respiratory failure is the main death cause in neuromuscular diseases. Non-invasive and volitional measures of inspiratory muscles strength include the nasal pressure with an occluded nostril (Psnip) and the maximal inspiratory pressure (PImax). Unfortunately, volitional maneuvers depend of patient effort. The aim of this research is to validate a non-invasive and non-volitional technique to evaluate diaphragm strength at neuromuscular diseases patients. The methodology consists to add to PImax and Psnip measures 5 phrenic nerves magnetical stimulation maneuvers (Pstim).Stimulations will be realize at 3 inspiratory pression levels (0, -1 cm H2O and -5 cm H2O).

Official Title
-----------------
Volontary Inspiratory Muscles Measures Compared With Phrenic Nerves Magnetic Stimulations Measures

Conditions
-----------------
Neuromuscular Diseases, Respiratory Failure

Intervention / Treatment
-----------------
* Other: Phrenic nerves magnetic stimulations


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years old and more men or women neuromuscular diseases Pimax and Snip evaluation Indication Exclusion Criteria: pregnant women Usual contre-indications for nuclear magnetic resonance

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Phrenic nerves magnetic stimulations<br> | Other: Phrenic nerves magnetic stimulations<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Magnetic stimulation pressure measure (Pstim), according to 3 conditions : Pstime, Pstim-5 and Pstim-1 (measured in cmH20). The condition which is most correlated with maximal inspiratory pressure (Pimax or Psnip) is selected. |  | 10 minutes |
TORQ Clinical Study

Study Overview
=================
Brief Summary
-----------------
The proposed trial is to evaluate the use of the TORQ closure assistance device and how it affects pain in the sternum, breathing and quality of life compared to traditional use of needle drivers or similar to close sternal wires.

Official Title
-----------------
The Influence of the TORQ Sternal Closure Assistance Device on Post-Operative Pain, Pulmonary Function and Quality of Life Compared to Traditional Manual Wire Closure: A Randomized Controlled Trial.

Conditions
-----------------
Post Cardiac Surgery, Sternal Closure

Intervention / Treatment
-----------------
* Procedure: TORQ assisted sternal closure
* Procedure: Conventional closure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Referred for elective cardiac surgery at St Paul's Hospital Expected to live greater than 12 months Capable of giving written informed consent Willing to participate in follow-up Greater than 18 years of age, and of legal age of consent in host country Exclusion Criteria: Patient has had previous median sternotomy, requiring redo sternotomy Surgeon has, prior to enrollment, elected to use alternative closure technique to the interrupted single wire circlage technique (e.g. Figure of 8 technique) Surgeon has elected, prior to enrollment. to treat with the TORQ as a prophylactic measure (e.g. in high risk cases where use of the TORQ has been shown to be effective in preventing dehiscence)

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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Manual closure<br>Patients are closed with a manual, straight wire, conventional closure technique | Procedure: Conventional closure<br> <br> * Other names: Straight wire closure;|
| Active Comparator: TORQ closure<br>Patients are undergo a TORQ assisted sternal closure | Procedure: TORQ assisted sternal closure<br> <br> * Other names: TORQ (Manufacturer: Kardium, Richmond, Canada);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory function |  | Pre-op, 2 and 4 days Post-op | 
| Pain Score | Patient reported pain on a scale of 1 to 10 for breathing, coughing and walking | 2, 4, 14, 30 and 90 days post op |
A Study to Determine the Satisfaction With Actonel in Postmenopausal Women With Osteoporosis

Study Overview
=================
Brief Summary
-----------------
The study in the labeled and real conditions of prescription of Actonel will investigate the satisfaction of patients with its new formulation: 35 mg Once A Week. The study will also measure response rates in CTX (the C-telopeptide of type I collagen) at baseline and after 12 weeks of treatment with risedronate 35 mg Once A Week.

Official Title
-----------------
Multicenter and Prospective Study to Determine the Satisfaction With Actonel (Risedronate Sodium) 35mg Once a Week Using Biochemical Markers of Bone as a Control, in Postmenopausal Women With Osteoporosis

Conditions
-----------------
Osteoporosis, Postmenopausal

Intervention / Treatment
-----------------
* Drug: Risedronate Sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal outpatients women > 55 and < 70 years who have a clinical presentation appropriate for treatment of established osteoporosis based on the investigator's clinical judgment (a T-score for BMD (DEXA) of lumbar spine or femoral neck less than or equal to - 2.5 from an assessment performed at screening or within 12 months prior to the screening visit or evidence of previous vertebral fracture). Exclusion Criteria: History of Cancer: Basal Cell or Squamous Cell carcinoma-documented 6-month remission. Diagnosis of hypocalcemia, hyperparathyroidism, hyperthyroidism. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Risedronate Sodium|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the satisfaction of subject with Actonel 35 mg |  | Once a Week in the treatment of postmenopausal osteoporosis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure response rates in CTX with Actonel 35 mg |  | Once A Week |
Assessment of Fetal Pancreatic Size and Maternal Serum Biomarkers in GDM

Study Overview
=================
Brief Summary
-----------------
The investigators aimed to determine the predictive values of fetal pancreas size and maternal serum biomarkers glycated albumin (GA) and insulin-regulated aminopeptidase (IRAP) for gestational diabetes mellitus (GDM).

Detailed Description
-----------------
The investigators aimed to determine the predictive values of fetal pancreas size and maternal serum biomarkers glycated albumin (GA) and insulin-regulated aminopeptidase (IRAP) for gestational diabetes mellitus (GDM).In this prospective observational study including 109 pregnant women, the fetal pancreas size and maternal serum biomarkers GA and IRAP were measured at the gestational age of 20-22 weeks and later at the gestational age of 24-28 weeks, in 19 participants of them, GDM was confirmed with the 75-g oral glucose tolerance test (OGTT) and the fetal pancreas size was measured in all the participants again.

Official Title
-----------------
Assessment of Fetal Pancreatic Size and Maternal Serum Biomarkers Glycated Albumin and Insulin-regulated Aminopeptidase in Women With Gestational Diabetes Mellitus

Conditions
-----------------
Gestational Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Maternal age between 18 and 42 years Gestational age between 20 and 28 weeks Exclusion Criteria: Multiple pregnancies Pregestational diabetes Fetal congenital malformations Placental and amniotic fluid abnormalities Preeclampsia Severe systemic disease Long-term systemic drug usage

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 42 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early prediction of gestational diabetes | Early prediction of gestational diabetes by the fetal pancreas measurement with ultrasound and maternal serum biomarkers glycated albumin and insulin-regulated aminopeptidase measured with ELISA | Two months |
Laparoscopic Antireflux Surgery Versus Endoscopic Full-thickness Gastroplication for Gastroesophageal Reflux Disease (GERD)

Study Overview
=================
Brief Summary
-----------------
Endoscopic full thickness gastroplication (Plicator-Procedure) has the potential to be a safe and effective alternative to laparoscopic antireflux surgery (LARS)to improve symptoms of GERD. This prospective randomized study compares objective and subjective outcome parameters of Plicator with that of LARS.

Conditions
-----------------
Gastroesophageal Reflux Disease

Intervention / Treatment
-----------------
* Procedure: anti-reflux surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: long history of GERD symptoms persistent or recurrent symptoms despite optimal medical treatment persistent or recurrent complications of GERD reduced quality of life owing to increasing esophageal exposure to gastric juice pathological values in the preoperative evaluated functional parameters. Exclusion Criteria: any distinct hiatal hernia detectable by gastroscopy or barium radiography dysphagia esophageal strictures poor physical status (American Society of Anesthesiologists (ASA) scores III and IV) and pregnancy.

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 |
| --- | --- |
| Active Comparator: laparoscopic antireflux surgery<br> | Procedure: anti-reflux surgery<br> <br> |
| Active Comparator: endoscopic full-thickness-gastroplication<br> | Procedure: anti-reflux surgery<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Synera™ for Epidural Needle Insertion

Study Overview
=================
Brief Summary
-----------------
We hypothesized that the analgesic effect of Synera™ analgesic patch would be superior to traditional infiltration with lidocaine for pain of epidural needle insertion in laboring parturients.

Official Title
-----------------
A Randomized, Double-Blind, Controlled Trial of the Synera™ vs. Lidocaine for Epidural Needle Insertion in Laboring Women

Conditions
-----------------
Pain Associated With Epidural Needle Insertion

Intervention / Treatment
-----------------
* Drug: Synera(TM)
* Other: Placebo patch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: older than 18 years, body mass index less than 45 kg•m-2, requesting a labor epidural Exclusion Criteria: hypersensitivity to any study medications

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Other: Placebo patch<br>* placebo patch applied 20 minutes prior to epidural<br>|
| Experimental: Synera(TM)<br> | Drug: Synera(TM)<br>* Synera(TM) patch applied 20 minutes prior to epidural<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject VRS (0 - 11) with epidural needle insertion |  | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anesthesia provider perceived VRS |  | 1 hour | 
| Need for deep infiltration with local anesthesia |  | 1 hour |
Thalidomide Anti-Angiogenesis Therapy of Relapsed or Refractory Leukemia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of Thalidomide in patients with leukemia.

Detailed Description
-----------------
Patients will take Thalidomide tablets at bedtime daily until remission. The dose will be increased gradually and modified according to side-effects. The drug will be given daily up to the time of complete remission then as long as it is beneficial.

Official Title
-----------------
UARK, 98-032, Thalidomide Anti-Angiogenesis Therapy of Relapsed or Refractory Leukemia

Conditions
-----------------
Leukemia

Intervention / Treatment
-----------------
* Drug: Thalidomide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of refractory or relapsed leukemia: acute leukemia, CML, CLLm and MDS. Signed informed consent, including patient agreeing to use safe contraceptive methods during the treatment and for at least 4 months after the treatment is completed Serum creatinine < or = 2.5mg/dL Serum bilirubin< or = 2.5mg/dL Negative pregnancy test Age 18 years or older Performance status < or = 3 Exclusion Criteria: Pregnant or lactating women Concurrent treatment with cytotoxic chemotherapy, or radiation History of seizures, neurotoxicity, or active CNS disease Serious infections not controlled by antibiotics

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Thalidomide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy and safety of Thalidomide in patients with leukemia. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Leukemia, Thalidomide, relapsed
An Observational Study Examining the Effect of Added MabThera Therapy in Patients With Untreated Chronic Lymphocytic Leukemia

Study Overview
=================
Brief Summary
-----------------
This study will examine the effectiveness of MabThera therapy added to a standard chemotherapy regimen for the treatment of previously untreated chronic lymphocytic leukemia (CLL). Patients who have received a single prior MabThera plus chemotherapy treatment are eligible. The overall response rate of patients treated for approximately 5 months (as per current label guidelines) will be analysed according to various factors (i.e., age, concurrent treatment, and chromosomal abnormalities).

Official Title
-----------------
A MULTICENTER NON-INTERVENTIONAL STUDY EVALUATING THE BENEFIT OF THE COMBINATION OF MABTHERA (RITUXIMAB) WITH STANDARD CHEMOTHERAPEUTIC REGIMENS IN PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA IN HUNGARY

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with first-line CLL having received only 1 cycle of MabThera chemotherapy aged >/= 18 years Exclusion Criteria: Pregnant or breast-feeding Receipt of an investigational drug within 30 days prior to entering the study

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 |
| --- | --- |
| CLL patients on Mabthera (rituximab)<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate (ORR) as assessed by the investigator using routine assessment techniques |  | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR analysed according to concomitant chemotherapy |  | 7 months | 
| ORR analysed according to age |  | 7 months | 
| ORR analysed according to CIRS score |  | 7 months | 
| ORR analysed according to certain chromosomal abnormalities |  | 7 months |
Incidence of Fat Embolism With Computer Assisted Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The study to determine the if the incidence of Fat Embolism is decreased using Computer Assisted technology when performing a Total Knee Arthroplasty.

Detailed Description
-----------------
Computer assisted total knee arthroplasty is at its inception currently. There are many unknowns about this specific technique, particularly when it comes down to fat embolism syndrome. There is a high incidence of fat embolism during total knee arthroplasty as seen both by echocariography as well as sampling of right atrial blood. During a jig-based, or traditional, total knee arthroplasty, a rod is placed inside the femur, and sometimes the tibia as well. Intrusumentations of the medullary canal is known to cause fat embolism. Fat embolism is a syndrome which can produce post-operative confusion, hypoxemia, all the way to post-op and intra-operative death. Computer assisted total knee arthroplasty does not use intramedullary jigs. It is presumed that by not instrumenting the medullary canal, the rate of fat embolism will be significantly reduced. Fifty patient s will be studied while they are having a computer assisted total knee arthoplasty. A PICC line will be placed in their arm by an interventional radiologist pre-operatively. This PICC line will be thread into the right atrium. Right atrial blood will be sent to pathology every 10 minutes during the 60 to 90 minute procedure and at intervals post-op. The right atrial blood will be stained for bone marrow elements. This study is to presumed to show yet another benefit of computer assisted surgery.

Official Title
-----------------
Incidence of Fat Embolism With Computer Assisted Total Knee Arthroplasty

Conditions
-----------------
Fat Embolism Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be a candidate for Computer Assisted Total Knee Arthroplasty Exclusion Criteria: Mentally incompetent patients excluded
Sexes Eligible for Study
-----------------
All

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fat Embolism Total Knee Arthroplasty