linjc16/ctgov huggingface dataset:
Asthma During Pregnancy; Impact of Severity

Study Overview
=================
Brief Summary
-----------------
bronchial asthma (BA) may affect pregnancy and this affection may increase with increasing asthma severity. This study was designed to detect the effect of asthma severity on the course of asthma during pregnancy and its effect on the pregnancy and perinatal outcome

Detailed Description
-----------------
This was prospective study conducted in sohag university hospital ( obstetric outpatient clinic, chest outpatient clinic and emergency department ).This study aimed to detect the effect of baseline asthma severity on the course of asthma during pregnancy and its effect on the pregnancy and perinatal outcome in the setting of advancements in the management and pharmacotherapy of asthma compared with that previously

Official Title
-----------------
Asthma During Pregnancy; Impact of Asthma Severity

Conditions
-----------------
Bronchial Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women in ages 18y or more with confirmed diagnosis of bronchial asthma presenting in1st trimester to inpatient or outpatients clinic of chest department. Exclusion Criteria: Patients with Chest diseases other than bronchial asthma and patients with cardiac disease.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intermittent& mild persistent asthma<br>According to asthma severity assessment, this group included asthmatic pregnant females patients with intermittent asthma and mild persistent asthma | |
| Moderate& severe persistent asthma<br>According to asthma severity assessment, this group included asthmatic pregnant females patients with Moderate& severe persistent asthma | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maternal complications | Occurrence any pregnancy related complication to the parturient women was recorded in both study groups. | from the start of inclusion to the study till termination of pregnancy, average 9 months period | 
| perinatal complications | Incidence of any fetal or neonatal complication was recorded | from the start of inclusion to the study till termination of pregnancy, average 9 months period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bronchial asthma, Asthma, pregnancy, Asthma severity
Follow-up of Children After Stuttering Treatment

Study Overview
=================
Brief Summary
-----------------
This study aims to determine the percentage and predictors of stuttering relapse following treatment with the Lidcombe Program. It will also investigate the effectiveness of sending reminder messages to parents to assist in reducing relapse.

Detailed Description
-----------------
Stuttering treatment becomes more time-consuming and less effective as children become older. Therefore it is crucial to prevent relapse following treatment in the early years. This study will investigate predictors of relapse and assess the effectiveness of a simple two-weekly user-friendly reminder to parents, about when and how to address any re-occurring stuttering after treatment. Results from the study may help to prevent stuttering relapse in this age group in the future.

Official Title
-----------------
Relapse Following the Lidcombe Program for Preschool Children Who Stutter

Conditions
-----------------
Stuttering

Intervention / Treatment
-----------------
* Behavioral: SMS (Short Message Service) reminders


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completion of stage I of Lidcombe Program Less than 1 percent syllables stuttered at recruitment Means of receiving SMS email or phone reminder

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 7 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: 1<br>SMS reminders | Behavioral: SMS (Short Message Service) reminders<br>* SMS reminders sent every 2 weeks<br>|
| No Intervention: 2<br>control group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of syllables stuttered |  | six monthly for three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| parent reported stuttering severity |  | six monthly for three years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stuttering, relapse, Lidcombe Program, Preschool children
Evaluation of the Effects of Carperitide in Patients With Congestive Heart Failure

Study Overview
=================
Brief Summary
-----------------
The study will evaluate the safety and efficacy of intravenous infusion of carperitide using pressure measurements inside the heart and great vessels and measuring carperitide concentration in the blood.

Official Title
-----------------
A Phase II, Dose Escalation Evaluation of the Pharmacokinetic and Hemodynamic Effects of Carperitide in Subjects With Congestive Heart Failure

Conditions
-----------------
Heart Failure, Congestive, Heart Decompensation, Left Ventricular Failure, Myocardiopathies, Systolic or Diastolic Left Ventricular Dysfunction

Intervention / Treatment
-----------------
* Drug: Carperitide
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Is hospitalized with congestive heart failure (CHF) Has a Swan-Ganz catheter inserted for CHF management and has pulmonary capillary wedge pressure 18 mmHg or higher Exclusion Criteria: Has had a heart transplant Requires mechanical ventilation or mechanical circulatory support

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Drug<br> | Drug: Carperitide<br> <br> * Other names: human recombinant atrial natriuretic peptide;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in pulmonary capillary wedge pressure (PCWP) |  | at 3 hours following initiation of study drug infusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Carperitide, Atrial Natriuretic Peptide, Treatment efficacy, Safety, Heart failure, Congestive, Pulmonary Artery Catheterization
Operative Versus Nonoperative Treatment for Scapula Fractures

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to contrast and evaluate the functional outcome of patients with operative vs. nonoperative treatment of scapula fractures. The specific aim of this project is to monitor the return to function of patients in both the operative and nonoperative cohorts. The potential impact is a clearer set of choices in treatment options for this type of injury.

Official Title
-----------------
Multicenter Prospective Study of Operative and Non-operative Treatment for Scapula Fractures

Conditions
-----------------
Scapula Fracture, Clavicle Fracture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 Years of Age or Older Displacement of glenoid neck and scapula body of greater than 2 cm Angular deformity between the fracture fragments of greater than 45 degrees. A combination of displacement greater than 1.5 cm AND angulation greater than 30 degrees A glenopolar angle less than 22 degrees A Double Lesion of the Superior Shoulder Suspensory Complex (SSSC) Exclusion Criteria: Age Less Than 18 years Old Brachial Plexus Injury Traumatic Brain Injury or Cognitive Disability preventing participation in the consent or post injury rehabilitation Spinal cord injuries resulting in paraplegic, quadriplegic disabilities or permanent ipsilateral peripheral nerve damage Ipsilateral Upper Extremity Injury Previous Shoulder Surgery Insufficient English proficiency to complete the DASH Questionnaire

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 |
| --- | --- |
| 1<br>Operative Treatment (Open Reduction Internal Fixation) | |
| 2<br>Non-operative/Conservative Care | |

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
-----------------
Displaced Scapula Fracture, Scapula Fracture, Extraarticular Scapula Fractures, Clavicle
Escalating Temporary Gastric Electrical Stimulation (GES) for Severe Gastroparesis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the physiologic effects of temporary gastric electrical stimulation in subjects with severe gastroparesis.

Detailed Description
-----------------
This study will look to determine the clinical benefit placing temporary gastric electrical stimulation, the ability to predict the clinical response to surgical implantation of GES, and the feasibility and patient tolerability of endoscopic placement of temporary Gastric Electrical Stimulator (t-GES),

Official Title
-----------------
Escalating Temporary Gastric Electrical Stimulation for Severe Gastroparesis

Conditions
-----------------
Gastroparesis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 3 months of gastroparesis-related symptoms, such as nausea, emesis, and/or retching Solid phase 4-hr gastric scintigraphy is consistent with gastroparesis within 3 months of study enrollment* retention at 2 hr: >60% or retention at 4 hr: >10% *Based on International consensus on gastric scintigraphy Exclusion Criteria: Gastric outlet, small bowel, or colon obstruction. Small bowel malrotation Inflammatory bowel disease Contraindication for surgical implantation of GES Presence of illness that may require MRI during the study; such as pituitary tumor, herniated disc, spinal stenosis, multiple sclerosis, etc. Significant comorbidity due to sever cardiovascular, renal, pulmonary, or liver disease. Significant coagulopathy Non-ambulatory patients: bed-ridden, nursing home resident, etc. Pregnancy Unable to give own informed consent Prisoners

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| Improvement in the symptoms of gastroparesis by t-GES in patients with severe gastroparesis. | Review the symptoms before and after the t-GES placements and follow for any improvement | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response to t-GES placement as measured by questionnaires | Measuring the responses to questionnaires before and after placement of GES | 1 year | 
| Develop a prospective registry in patients undergoing escalating t-GES | Have a database of patients undergoing t-GES placement | 1 year | 
| determine the feasibility and patient tolerability of endoscopic placement of t-GES | Determine if placement of t-GES is feasible and if the patients tolerate the t-GES | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bloating, gastroparesis, gastric electrical stimulator, GES, vomiting, nausea, postprandial fullness, epigastric pain
A Trial Investigating the Pharmacokinetic Properties of NN1218 in Subjects With Diabetes Mellitus, Type 1

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetic (the rate at which the body eliminates the trial drug) and pharmacodynamic (the effect of the trial drug on the body) profiles of NN1218 in comparison with insulin aspart.

Official Title
-----------------
A Randomised Trial Investigating the Pharmacokinetic Properties of NN1218 in Subjects With Type 1 Diabetes

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: Faster-acting insulin aspart
* Drug: insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes mellitus for at least 12 months Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for more than 12 months. Body Mass Index (BMI) between 18.0-28.0 kg/m^2 (both inclusive) Exclusion Criteria: Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to trial start Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment sequence 1<br> | Drug: Faster-acting insulin aspart<br>* Single dose of 0.2 U/kg body weight faster-acting insulin aspart injected subcutaneously (under the skin) followed by single dose of 0.2 U/kg body weight insulin aspart injected subcutaneously (under the skin)<br>* Other names: NN1218;|
| Active Comparator: Treatment sequence 2<br> | Drug: insulin aspart<br>* Single dose of 0.2 U/kg body weight insulin aspart injected subcutaneously (under the skin) followed by single dose of 0.2 U/kg body weight faster-acting insulin aspart injected subcutaneously (under the skin)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the serum insulin aspart concentration-time curve |  | from 0-1 hour after trial drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the serum insulin aspart concentration-time curve |  | from 0-12 hours after trial drug administration |
Competency Training, Staff Performance, & Family Outcomes

Study Overview
=================
Brief Summary
-----------------
This proposal examines the impact of an augmented competency based approach to training of home visitors and supervisors for delivery of the Nurse Family Partnership (NFP) on staff performance, fidelity to the program model, and family outcomes relative to child maltreatment and early behaviors associated with youth violence. The central premise underlying the proposed study is that the augmented competency based curriculum and clinical consultation to supervisors will improve nurses' knowledge and skills in working with families, which in turn, will lead to greater fidelity to the home visit guidelines (i.e., quality implementation), which in turn, will result in better maternal and child health outcomes.

Detailed Description
-----------------
A two group experimental design will be used to examine the impact of an augmented competency-based curriculum for NFP home visitors and supervisors coupled with structured clinical consultation by NFP National Office professional development staff, as compared against the standard curriculum currently used, on quality of program implementation and family outcomes.

Official Title
-----------------
University of Colorado Health Sciences Center: Competency Training, Staff Performance, & Family Outcomes

Conditions
-----------------
Child Abuse

Intervention / Treatment
-----------------
* Behavioral: Home visitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First time mothers (enrolled during pregnancy) and their children Exclusion Criteria: See above. No other exclusion criteria will be used.
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home visitation<br>In the intervention condition, nurse home visitors receive enhanced training to improve delivery of parenting interventions to mothers | Behavioral: Home visitation<br>* Home visitation to improve maternal health and well-being and parenting practices<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of children's home environment |  | 12 and 24 months | 
| Children's emergency room visits/hospitalizations |  | 6, 12, 18, and 24 months | 
| Children's adjustment and behavior |  | 21-22 months | 
| Children's language development at 21 months |  | 21 months | 
| Referrals to child protective services 6, 12, 18, and 24 months |  | 6, 12, 18, and 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
home visitation, family outcomes, competency training
Dexamethasone for Reduction of Post Thoracotomy Pain Syndrome

Study Overview
=================
Brief Summary
-----------------
Post thoracotomy pain syndrome still affects 50% of patients after a thoracic surgery. Pathogenesis is unclear but there is growing evidence that neuro inflammation may play a significant role. Dexamethasone is a very potent anti-inflammatory drug. The hypothesis of this study is that dexamethasone, given pre operatively, would help reduce the incidence of post thoracotomy pain syndrome 3 months after surgery, by reducing the inflammatory response, in patients undergoing elective thoracic surgery that includes thoracic epidural analgesia.

Official Title
-----------------
Impact of Dexamethasone on the Post Operative Inflammatory Response and on the Occurrence of Post Thoracotomy Pain Syndrome

Conditions
-----------------
Chronic Pain, Dexamethasone, Thoracic Surgery, Cytokines

Intervention / Treatment
-----------------
* Drug: Dexamethasone
* Drug: Normal Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective thoracic surgery using a thoracotomy incision and thoracic epidural analgesia ASA I-III age 18-75 yo Exclusion Criteria: contra-indication to thoracic epidural analgesia patient refusal patients already taking cortisone or dexamethasone patients on chronic opioid medication

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dexamethasone 10 mg<br>Dexamethasone 10 mg will be given as a single-dose, pre incision, intravenously | Drug: Dexamethasone<br>* 10 mg (2.5 ml)<br>* Other names: decadron;|
| Placebo Comparator: normal saline<br>Patients in this group will receive 2.5 mL of normal saline intravenously, pre-incision | Drug: Normal Saline<br>* 2.5 mL normal saline<br>* Other names: Placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cytokine elevation |  | 24 h after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of post thoracotomy pain syndrome |  | 3 months after surgery | 
| incidence of post thoracotomy pain syndrome |  | 6 months after surgery | 
| incisional and shoulder pain |  | acute post operative period | 
| Brief pain inventory questionnaire |  | three months after surgery | 
| Brief pain inventory questionnaire |  | 6 months after surgery | 
| Leeds Assessment of Neuropathic Signs and Symptoms questionnaire |  | three and six months after surgery | 
| cytokine elevation |  | 1h after surgery | 
| cytokine elevation |  | 48 h after surgery |
Efficacy of Nucleo CMP Forte in Traumatic Brain Injury in Pediatrics

Study Overview
=================
Brief Summary
-----------------
Efficacy of Nucleo CMP Forte in Traumatic Brain Injury in Pediatrics

Detailed Description
-----------------
The study aims to study the Efficacy of Nucleo CMP Forte in Traumatic Brain Injury in Pediatrics

Official Title
-----------------
Efficacy of Nucleo CMP Forte in Traumatic Brain Injury in Pediatrics: A Randomized Controlled Trial

Conditions
-----------------
Brain Injuries

Intervention / Treatment
-----------------
* Drug: Nucleo CMP Forte


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with traumatic brain injury: Moderate and Severe. Exclusion Criteria: Underlying CNS disorders,

Ages Eligible for Study
-----------------
Maximum 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nucleo CMP forte<br>Nucleo CMP forte twice daily for 6 weeks with supportive treatment. | Drug: Nucleo CMP Forte<br>* Nucleo CMP Forte twice daily for 6 weeks<br>* Other names: Nucleoforte;|
| No Intervention: Supportive treatment<br>Supportive treatment only. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with improved glasgow coma score | The number of patients with improved glasgow coma score | 2 months |