linjc16/ctgov huggingface dataset:
Efficacy of Adding Azithromycin to Cephalosporin Before Cesarean Delivery

Study Overview
=================
Brief Summary
-----------------
efficacy of adding azithromycin to cephalosporin before cesarean delivery

Detailed Description
-----------------
efficacy of adding azithromycin to cephalosporin for the prophylaxis against infectious morbidity following cesarean delivery in high risk women

Official Title
-----------------
Efficacy of Adding Azithromycin to Cephalosporin for the Prophylaxis Against Infectious Morbidity Following Cesarean Delivery in High Risk Women

Conditions
-----------------
Wound Sepsis

Intervention / Treatment
-----------------
* Drug: cephalosporin
* Drug: Azithromycin Tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age between 17 and 39 years gestaional age between 37 to 42 weeks elective cesarean delivery obese women Exclusion Criteria: diabetic women on corticosteroids intraopertaive complication in previous section history of septic woun prelabour rupture of membrane >12 hours

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 39 Years

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: cephalosporin arm<br>72 women will receive single antibiotic chemotheraby first generation cephalosporin (cefazolin) 2 gm iv within 30 minutes before skin incision | Drug: cephalosporin<br>* 72 women will receive single antibiotic chemotherapy(Cefazolin) 2 gm iv within 30 minutes before skin incision<br>|
| Active Comparator: cephalosporin +azithromycin arm<br>72 women will receive combined antibiotic chemotherapy azithromycin (Azrolid) 1 gm single oral dose 2 hours before cesarean delivery + cephalosporin(Cefazolin) 2 gm iv within 30 minutes before skin incision | Drug: cephalosporin<br>* 72 women will receive single antibiotic chemotherapy(Cefazolin) 2 gm iv within 30 minutes before skin incision<br>Drug: Azithromycin Tablets<br>* 72 women will receive combined antibiotic chemotherapy azithromycin(Azrolid) 1 gm single oral dose 2 hours before cesarean delivery +cephalosporin(Cefazolin) 2 gm iv within 30 minutes before skin incision<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of women with wound infection | superficial and deep surgical site wound infection will be looked for by laboratory confirmation | after 14 days post cesarean delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of women with postpartum endometritis | fever, abdominal pain , uterine tenderness will be looked for | after 14 days post cesarean delivery |
Reliability and Validity of Modified Postural Assessment Scale for Stroke Patients and the Application of This Scale on Early Detection of Patients With Stroke at High Risk of Falls

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are to investigate the reliability and validity of the modified Postural Assessment Scale for Stroke Patients (mPASS) and its applications in early detection of fall-prone patients. The intraclass correlation coefficient will be used to examine the intra-rater reliability, inter-rater reliability, and the Cronbach's alpha will be used to examine the internal consistency of the 16 items of mPASS.

Detailed Description
-----------------
Due to the impaired balance function, patients with stroke show high incidence of falls. Impaired postural stability has been shown as one of the primary risk factors of falls in these patients. Research has shown that patients who have moderate level of mobility and stability are more likely to fall than those who have very good or very poor mobility and stability. Therefore, there is an urgent need for physical therapists, who are used to play an important role in improving balance function of patients with stroke, to be able to early detect stroke patients who are at high risk of falls, and to implement fall prevention training and education on these patients. However, to date, there is not any clinical assessment scale that can be used for early detection of fall-prone stroke patients.

Official Title
-----------------
Reliability and Validity of Modified Postural Assessment Scale for Stroke Patients and the Application of This Scale on Early Detection of Patients With Stroke at High Risk of Falls

Conditions
-----------------
Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: between 30 and 80 years old first onset or recurrent stroke as a result of a single cerebral vascular accident (ischemic or hemorrhage stroke) ever received medical or rehabilitation therapies at National Taiwan University Hospital being willing to take the clinical assessments and accept the vedio record Exclusion Criteria: having unstable vital sign, unconsciousness, or having serious cognitive, perception, and language impairment, and being unable to follow the order of the experimenter having other neurological diseases(ex. Parkinson's disease or cerebellar disease etc.), or moderate to severe neuromuscular or musculoskeletal disorders, or disorders from systematic diseases those will influence the balance performance other than stroke

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke patients, Falls, Reliability, Validity
Topical Silver for Prevention of Wound Infection After Cesarean Delivery

Study Overview
=================
Brief Summary
-----------------
A common concern in any surgical procedure is the occurrence of infection. Silver-containing treatments are popular and used in wound treatment; however, there is presently little evidence of the effectiveness of silver-containing treatment for the prevention of obstetrical wound infection. We plan to investigate the rate of infection in women experiencing cesarean sections at Vanderbilt University Medical Center (VUMC) by comparing the infection rate based on a randomized choice of silver-containing wound dressings to soft cloth adhesive wound dressings.

Official Title
-----------------
Topical Silver for Prevention of Wound Infection Post Cesarean Delivery: A Randomized Controlled Trial

Conditions
-----------------
Wound Infection

Intervention / Treatment
-----------------
* Device: Silver-containing surgical dressing
* Device: Cloth adhesive dressing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cesarean delivery with pfannenstiel incision Exclusion Criteria: Incision other than pfannenstiel Silver allergy Inability to provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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: Silver-containing surgical dressing<br>Self adhesive 4 x 10 dressing impregnated with nanocrystalline silver | Device: Silver-containing surgical dressing<br>* Dressing placed over surgical incision and remain for 3-5 days<br>* Other names: Acticoat;|
| Active Comparator: Cloth adhesive dressing<br>Soft cloth adhesive wound dressing | Device: Cloth adhesive dressing<br>* Cloth adhesive dressing placed over surgical incision and remains for 3-5 days<br>* Other names: Medipore;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Silver Treatment Efficacy | As measured by number of patients with postop infections at 6 wks | 6 weeks postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection Rate Adjusted for Maternal BMI |  | 6 weeks postpartum | 
| Patient Dressing Cost | Total cost of dressings per group based on 1 dressing per patient | Postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wound infection prevention, Silver-containing surgical dressing, Cesarean delivery infection prevention
Comparative Evaluation of Quadratus Lumborum and Transverses Abdominis Plane Block for Postoperative Pain Relief in Lower Abdominal Surgeries

Study Overview
=================
Brief Summary
-----------------
Two ultrasound guided techniques to give postoperative pain relief to the patients following abdominal surgeries would be compared using scoring systems for pain relief and scientific methods. while one technique is routinely used, other i.e quadratus lumborum has been recently described and relies on posterior deposition of the drug. Both the techniques are safe and ultrasound imaging is to be used for guidance.

Official Title
-----------------
Comparative Evaluation of Quadratus Lumborum and Transverses Abdominis Plane Block for Postoperative Pain Relief in Lower Abdominal Surgeries

Conditions
-----------------
Pain Relief to the Patient Following Abdominal Surgeries

Intervention / Treatment
-----------------
* Procedure: ultrasound guided quadratus lumborum or Transversus Abdominis plane block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing lower abdominal surgery 18-60 yrs of age Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: quadratus lumborum<br> | Procedure: ultrasound guided quadratus lumborum or Transversus Abdominis plane block<br>* The intervention consists of giving ultrasound guided local anaesthetic (0.125% bupivacaine ) in the quadratus lumborum plane or the transversus abdominis plane after randomization. These planes and technique for these procedures are well described in literature.<br>|
| Experimental: TAP(Transversus abdominis plane)<br> | Procedure: ultrasound guided quadratus lumborum or Transversus Abdominis plane block<br>* The intervention consists of giving ultrasound guided local anaesthetic (0.125% bupivacaine ) in the quadratus lumborum plane or the transversus abdominis plane after randomization. These planes and technique for these procedures are well described in literature.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain relief following abdominal surgery. Visual Analogue Scale (VAS) would be used to record pain at rest. In this patient is asked to describe his/her pain on a scale from 0-10. |  | 24 hrs |
Electronic Intervention to Chronic Opioid Therapy

Study Overview
=================
Brief Summary
-----------------
This pilot study will attempt to apply an electronic chart intervention to improve safety for patients on chronic opioid medications.

Official Title
-----------------
An Electronic Chart Intervention to Improve Safety for Patients on Chronic Opioid Therapy

Conditions
-----------------
Chronic Opioid Therapy

Intervention / Treatment
-----------------
* Other: opioid prescribing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients prescribed long-term opioid therapy of doses greater than 90 morphine equivalent daily dose (MEDD) Exclusion Criteria: Patients prescribed short-term opioid medications for acute pain (less than a 90-day supply over the past 120 days), sublingual buprenorphine, methadone maintenance for opioid use disorder or with oncology or palliative care diagnoses will be excluded.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electronic Intervention<br>Individualized opioid taper and safety recommendations will be communicated to prescribers via an electronic medical record encrypted message. | Other: opioid prescribing<br>* Individualized taper and safety recommendations will be communicated to prescribers via an electronic medical record encrypted message.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the number of patients who receives naloxone prescription | Change in the number of patients who receives naloxone prescription | baseline, 1, 3- and 6-months and 12 months | 
| change of number of documentation about safety discussions | change of number of documentation about safety discussions | baseline, 1, 3- and 6-months and 12 months | 
| change of number of order for urine toxicology screening | change of number of order for urine toxicology screening | baseline, 1, 3- and 6-months and 12 months | 
| change of number of documentation of prescription drug monitoring program (CURES) results | change of number of documentation of prescription drug monitoring program (CURES) results | baseline, 1, 3- and 6-months and 12 months | 
| change of number of signed opioid informed consent forms | change of number of signed opioid informed consent forms | baseline, 1, 3- and 6-months and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in number of patients on long-term high risk doses of opioid pain medications | decreases in daily dose of opioids and number of patients on opioids ≥ 90mg MEDD | baseline, 1, 3- and 6-months and 12 months |
Characterisation of Biofilm of the Chronic Wounds

Study Overview
=================
Brief Summary
-----------------
In this prospective observational study, the investigators tried assess the presence of biofilm on chronic wound samples coming from a large cohort study of patients, whilst cross-referencing the clinical, bacteriological and wound care observations.

Conditions
-----------------
Chronic Wounds

Intervention / Treatment
-----------------
* Biological: 1 clinical examination of the wound, 1 sample taken with the curette, 1 sample by swabbing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with chronic wounds (period > 6 weeks) > 10 cm2 Patient age >18 for the 3 French centres Patient participation in a follow-up program for treatment of their wound > 1 month Availability of patient information and written informed consent from them or their legal representative Exclusion Criteria: Patients unable to submit to medical follow-up in the trial due to geographical constraints etc Patients deprived of freedom or under guardianship

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: Patients with chronic wounds<br> | Biological: 1 clinical examination of the wound, 1 sample taken with the curette, 1 sample by swabbing<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical examination |  | 1 month | 
| characterisation of biofilm by fluorescence microscopy and confocal |  | 1 month |
Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis

Study Overview
=================
Brief Summary
-----------------
Juvenile onset recurrent respiratory papillomatosis (JORRP) is a rare, difficult to treat, benign tumor of the pediatric airway. Current therapy is mainly surgical, but in a significant portion of patients adjuvant therapy is required to control the disease process. Although multiple adjuvant medical therapies have been tried, success has been limited. We have seen some success in a limited amount of patients using orally administered propranolol. Our goal is to enroll a larger cohort of patients to determine the effectiveness of propranolol as an adjuvant therapy for JORRP.

Official Title
-----------------
Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis

Conditions
-----------------
Recurrent Respiratory Papillomatosis

Intervention / Treatment
-----------------
* Drug: Propranolol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Biopsy proven with appropriate Human Papilloma Virus typing Recurrent Respiratory Papilloma 2. Child under age 10 3. Informed consent and where appropriate informed assent 4. Children who have undergone at least 4 documented surgical interventions in the past year. Exclusion Criteria: Parental or child refusal to participate Heart failure Atrio-ventricular heart block Cardiac anomalies Low resting heart rate Low resting blood pressure Wolff-Parkinson White Syndrome Unexplained syncope Asthma or Reactive airway disease Renal or liver failure Expected long fasting periods, >12 hours Diabetes Mellitus Hypersensitivity to propranolol

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Children treated with propranolol<br> | Drug: Propranolol<br>* Propranolol 2mg/kg divided twice daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decreased number of surgeries |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved voice quality |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
respiratory, papilloma, pediatric, juvenile
Are Parents Privileged Listeners Their Baby ?

Study Overview
=================
Brief Summary
-----------------
The crying baby is a sound signal including information relating to this individual identity or related to its physiological or motivational state. The objective of the study is to determine the implementation of the recognition of individual tone of the baby by his parents and acoustic modulation of the baby based on parental response. The detailed study of the acoustic structure of crying and analysis of parental perception will determine the dynamics during the first weeks of life of this recognition, and the influence of factors such as parental presence, or breastfeeding . For this study is organized in three stages: first, the recording of the baby's crying Secondly, a listening test parental soundtracks and third analysis of the acoustic structure of crying and parental response.

Official Title
-----------------
Are Parents Privileged Listeners Their Baby ?

Conditions
-----------------
Newborn

Intervention / Treatment
-----------------
* Behavioral: Crying record


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: born in the University Hospital of Saint Etienne (inborn) whatever its term birth Exclusion Criteria: Congenital oropharyngeal tract preventing vocalization physiological newborn

Ages Eligible for Study
-----------------
Maximum Age: 1 Week

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Babies<br>Any child born in the University Hospital of Saint Etienne (inborn) whatever its term birth, hospitalized in a neonatal unit at the time of registration (after 37 weeks of gestation for preterm infants) or maternity | Behavioral: Crying record<br>* Recording spontaneous crying is as soon as possible after birth. Crying is recorded twice during the first week of life. Listening tests: Tests will be conducted playbacks with the father and mother separately, and with a staff<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Crying recorded | The acoustic structure of crying recorded the first days of life will be analyzed and aims to characterize an individual signature and the dynamic function of time of this structure. | Second day of life of the parent's child | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biological correlation | The acoustic structure of crying will also be studied to establish a possible correlation with biological parameters baby | Second day of life of parents' child | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Crying record, Newborn