linjc16/ctgov huggingface dataset:
Multi-resistant Enterobacteriaceae Colonisation in Less Than 32 Weeks Pregnant Women Admitted to the Hospital.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the prevalence and risk factors for multi-resistant enterobacteriaceae colonization in less than 32 weeks pregnant women admitted to the hospital and its transmission to the newborn, in order to avoid neonatal intensive care unit spread and nosocomial outbreaks.

Official Title
-----------------
Multi-resistant Enterobacteriaceae Colonisation in Less Than 32 Weeks Pregnant Women Admitted in the Hospital: a Multicenter Study (EME Study).

Conditions
-----------------
Multi-resistant Enterobacteriaceae Colonisation, Pregnancy, Nosocomial Outbreaks

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Less than 32 weeks pregnant woman Admitted to the hospital Exclusion Criteria: Screening done after 48 hours of admission When delivery occurs before screening is performed
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant women colonized by resistant enterobacteria<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of multi-resistant enterobacteriaceae colonisation in less than 32 weeks pregnant women |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of multi-resistant enterobacteriaceae colonisation of African or Asian pregnant women |  | 18 months | 
| Incidence of multi-resistant enterobacteriaceae colonisation of pregnant women admitted to the hospital by preterm premature rupture of membranes (PPROM) |  | 18 months | 
| Transmission rate from the colonized woman to the newborn |  | 18 months | 
| Number of multi-resisitant enterobacteriacea sepsis in the Neonatal Unit |  | 18 months |
Idiopathic Dilated Cardiomyopathy

Study Overview
=================
Brief Summary
-----------------
To determine the familial occurrence and pathogenesis of idiopathic dilated cardiomyopathy.

Detailed Description
-----------------
BACKGROUND: In 1987 idiopathic dilated cardiomyopathy was a disorder of unknown cause that directly affected one or both cardiac ventricles in a diffuse or multifactorial fashion, and that produced heart failure, at least in some patients. Although a viral etiology had been proposed, dilated cardiomyopathy could be associated with numerous genetic and non-genetic diseases. However in 1987, the role of genetic factors was not known in humans. Although the condition was usually dismissed as sporadic, numerous families with multiple affected members have been observed. The role of atrial natriuretic peptide levels in the pathogenesis or progression of idiopathic dilated cardiomyopathy was just beginning to be explored in 1987. Although Syrian hamster studies did not suggest a genetic deficiency as the primary cause of dilated cardiomyopathy in that model, it was thought possible that ANP production or levels were somehow involved in how the myocardium responds in idiopathic dilated cardiomyopathy patients. DESIGN NARRATIVE: Eligible patients were interviewed and asked whether any first-degree relatives were willing to participate. If family members participated, a three generation pedigree was constructed and first-degree relatives contacted. The relatives were interviewed for a medical history and medical records from other institutions were reviewed. Each family member had a brief cardiovascular examination, a 12-lead electrocardiogram and 2-dimensional, M-mode, and Doppler echocardiogram. Blood was drawn for determination of atrial natriuretic peptide (ANP) levels. The contributions of variability in age, sex, drug use, smoking, and other concomitants to variability in ANP and echocardiographic data were estimated. After removing these sources of variability, the strength of similarity among family members was assessed. The relative contributions of genes and shared environments to the similarity among family members were estimated. Heterogeneity in the mean levels of echocardiographic indices and ANP levels, familial aggregation and etiology of aggregation were assessed between families with familial idiopathic dilated cardiomyopathy and families with non-familial idiopathic dilated cardiomyopathy. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Heart Diseases, Cardiomyopathy, Congestive

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

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

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |
Safety and Efficacy Study of High Dose Colistin

Study Overview
=================
Brief Summary
-----------------
Colistin is a rapidly acting bactericidal antimicrobial agent that possesses a post antibiotic effect against MDRO Gram-negative bacteria, such as as Pseudomonas aeruginosa, Acinetobacterbaumannii, and Klebsiella pneumonia.

Official Title
-----------------
Use Of High Dose Colistin in Multi Drug Resistant Gram Negative Infections in Critically Ill Adult Patients. Randomized Controlled Clinical Trial

Conditions
-----------------
Infectious Diseases

Intervention / Treatment
-----------------
* Drug: High Dose Colistin
* Drug: Standard Dose Colistin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient age more than or equal 18 years old. Patient has clinical signs and symptoms of infection with suspected or proven infection due to Carbapenem resistant microorganism. Patient was started with Empirical therapy of Colistin and positive MDRO within 5 days of empirical therapy. Exclusion Criteria: Patient age less than 18 years. Pregnant patient. If received Colistin treatment for less than 72 hours. Renal Replacement Therapy.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Dose Colistin<br>High dose colistin protocol | Drug: High Dose Colistin<br>* High Dose Colistin<br>* Other names: colistin;|
| Active Comparator: Standard Dose Colistin<br>Standard dose of colistin | Drug: Standard Dose Colistin<br>* Standard Dose Colistin<br>* Other names: Colistin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate safety of high dose Colistin | Evaluate the safety of high dose Colistin to treat MDRO infection in critically ill patients. The safety of high dose Colistin will be determined by number of participants whom renal function will be deviated from the baseline after administering high dose of Colistin. | 7 to 21 days after giving Colistin | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  | 7 days after the end of therapy or at 28 days after enrollment | 
| Ventilation free days |  | 28 days after enrollment | 
| Length of ICU stay |  | 28 days after enrollment | 
| Microbiological response | whole body cultures will be done at day 7 of treatment and at the end of therapy | A day 7 and at the end of therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICU, colistin, critical care
Nalbuphine as an Adjuvant to Levobupivacaine in Caudal Analgesia in Children

Study Overview
=================
Brief Summary
-----------------
Caudal anesthesia is the single most important pediatric regional anesthetic technique and is increasingly performed in pediatric regional anesthesia practices. It is preferred in order to relieve intra-operative and postoperative pain in children of all age groups undergoing pelvi-abdominal or lower limbs surgeries using levobupivacaine 0.25%.Various adjuvants have been added to levobupivacaine to prolong postoperative caudal analgesia. Nalbuphine as many opioids can be added in caudal analgesia. This prospective randomized double blind study was done to compare the effects of plain levobupivacaine versus Levobupivacaine plus nalbuphine single-shot for postoperative pain relief in children undergoing hypospadius repair surgery.

Official Title
-----------------
Nalbuphine as an Adjuvant to Levobupivacaine in Caudal Analgesia in Children

Conditions
-----------------
Caudal Anesthesia

Intervention / Treatment
-----------------
* Procedure: caudal block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I, II. Age 1-3 years. Patients scheduled for hypospadias repair surgeries. Exclusion Criteria: ASA III, IV. Signs of infection at site of injection. Known coagulopathy disorder. Mental and / or developmental retardation.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 3 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group L (levobupivacaine only group)<br>Caudal block was done in this group using levobupivacaine 0.25% with the dose of 1 ml /kg plus one ml normal saline after induction of general anesthesia. | Procedure: caudal block<br>* caudal block<br>|
| Active Comparator: Group L+N(levobupivacaine plus nalbuphen group)<br>Caudal block was done in this group using levobupivacaine 0.25% with the dose of 1 ml /kg and nalbuphine 0.1 mg /kg in one ml normal saline after induction of general anesthesia. | Procedure: caudal block<br>* caudal block<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Postoperative analgesia | Face legs activity cry consolablity score (FLACC) (0-10) Score: 0, no pain; 1-3, mild pain; 4-7, moderate pain; 8-10, severe pain | 24 hours | 
| duration of analgesia | Time to first analgesia request (TFAR) | 24hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analgesic consumption | total dose of rescue analgesic | 24 hours |
Rapid Maxillary Expansion and Protraction by Expander Differential Opening EDO in Cleft Lip and Palate Patients

Study Overview
=================
Brief Summary
-----------------
maxillary expansion in cleft palate patient with expander and using face mask.

Detailed Description
-----------------
patient with cleft palate and maxillary constriction, deficiency will be treat using expander with differential opening which has two screws on anteriorly and another posteriorly positional in midline palate anteriorly as much as possible. rapid maxillary expansion will be using one turns in day(two turns in the morning and two turns in the evening). with petit face mask for maxillary protraction and superimposition CBCT will be taken between before and after treatment .

Official Title
-----------------
Evaluation of the Treatment Outcome of Cleft Palate Patients Treated With Differential Opening Expander With Rapid Protocol and Face Mask Using CBCT

Conditions
-----------------
Cleft Lip and Palate

Intervention / Treatment
-----------------
* Device: expander with deferential opening and petit face mask


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ● Patients of both sexes. Cleft lip and palate patients. All patient age range 8-12 years. All the case showed maxillary arch constriction and deficiency. All patients had maxillary permanent first molars. Primary lip adhesion and palatal closure. Exclusion Criteria: • Absent maxillary permanent first molars. Patients had received any surgical assisted rapid maxillary expansion, maxillary protraction or fixed orthodontics before. Less than two dental unit beside maxillary first molar. Uncooperative patients/parents.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 12 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: Cleft Lip and Palate Patient<br>Cleft patient with transverse maxillary constriction and anteroposterior deficiency | Device: expander with deferential opening and petit face mask<br>* bonded expander with two screws and vertical hooks for attachment face mask. adjustment face mask with forehead and chin anchorage<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in 3 dimensions of skull before and after expansion | Full skull Cone Beam Computerized Tomography | Six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cleft palate patient, Rapid maxillary expansion RME, cone beam computed tomography CBCT, expansion, face mask
Treatment of Bacterial Vaginosis With Oral Tinidazole

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to confirm the safety and efficacy of oral tinidazole for the treatment of bacterial vaginosis.

Detailed Description
-----------------
Tinidazole is a second-generation nitroimidazole i.e. an updated form of the standard drug used to treat bacterial vaginosis (metronidazole). Two dosing regimens are being compared to placebo to treat bacterial vaginosis, one of the most common vaginal infections.

Official Title
-----------------
A Phase III Randomized, Multi-center, Double-blind, Double-dummy, Placebo-controlled Treatment Trial of Bacterial Vaginosis With Tinidazole Oral Tablets.

Conditions
-----------------
Bacterial Vaginosis

Intervention / Treatment
-----------------
* Drug: Tinidazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical and microbiological diagnosis of bacterial vaginosis - Exclusion Criteria: Other sexually transmitted 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?
-----------------

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapeutic efficacy |  |  | 
| Safety |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical efficacy |  |  | 
| Microbiological efficacy |  |  |
Isolation and Authentication of Mesenchymal Stem Cell-like Progenitor Cells From the Degenerated Intervertebral Disc of Lumbar Spine

Study Overview
=================
Brief Summary
-----------------
The study is designed for evaluating the presence of mesenchymal stem cells of vertebral disc. Isolation and authentication of these cells may be applied for the vertebral disc regeneration and the research tissue engineering.

Detailed Description
-----------------
We will collect the degenerative disc from adults and isolate the mesenchymal stem cell-like precursors cells. The function of osteogenic, chondrogenic, and lipogenic differentiation will be authenticated. The results will offer the information for cell source of tissue engineering in the future.

Official Title
-----------------
Isolation and Authentication of Mesenchymal Stem Cell-like Progenitor Cells From the Degenerated Intervertebral Disc of Lumbar Spine

Conditions
-----------------
Lower Back Pain, Disc Degeneration

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The adults with disc degeneration（age >= 20 years old） A. Herniated intervertebral disc. B. Spondylolisthesis. C. Spondylolysis. D. Other causes of disc degeneration. Exclusion Criteria: Age < 20 years old. Pregnancy. Spinal tumors. Spinal infections.

Ages Eligible for Study
-----------------
Minimum Age: 20 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
-----------------
Vertebral disc, mesenchymal stem cell.
Biological MArkers of FRAilty in Elderly Subjects

Study Overview
=================
Brief Summary
-----------------
Epidemiological data from Europe have shown that around 30% of subjects aged over 65 years of age are pre-frail, and 15% are frail. Recent research has demonstrated that identifying frailty and implementing preventive measures can help to slow cognitive decline. Screening and treating frailty seem to be a good start towards preventing dependency. On the premise that this frailty is the result of more pronounced tissue alterations in certain elderly subjects, assessment of post-translational modification derived products (PTMDP) represents an innovative evaluation method. These include advanced glycation end-products (AGE), and carbamylation-derived products (homocitrulline). Indeed, the intensity of these modifications increases with ageing, and assessing the products resulting from these alterations could show the existence of differences according to frailty status. This would make it possible to adapt treatment accordingly in elderly subjects.

Official Title
-----------------
PTMDP (Post-translational Modification Derived Products) as Markers of Frailty in Elderly Subjects

Conditions
-----------------
Elderly Persons

Intervention / Treatment
-----------------
* Other: Blood collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: With social security coverage Accept to participate in the study and sign informed consent for the study and for the collection of biological samples Exclusion Criteria: - < 65 yo

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: elderly subjects<br> | Other: Blood collection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-translational modification derived-products (PTMDP) quantification by Multidimensional Chromatography Coupled withTandem Mass Spectrometry (LC/LC-MS/MS) |  | baseline |
Treatment of Prisoners With Attention Deficit Hyperactive Disorder in Trondheim Prison

Study Overview
=================
Brief Summary
-----------------
The treatment of ADHD in jail will help the prisoners in their rehabilitation process

Detailed Description
-----------------
Prisoners with ADHD will be offered treatment with Stratera, and we wanted to study their use of the prisons rehabilitation offers as school, programs and work training before and after treatment with Stratera.

Official Title
-----------------
Treatment of Prisoners With Attention Deficit Hyperactive Disorder in Trondheim Prison

Conditions
-----------------
Attention Deficit Hyperactivity Disorder

Intervention / Treatment
-----------------
* Drug: Strattera


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All prisoners that fullfill the diagnostic criterias for ADHD - Exclusion Criteria: All other prisoners -

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

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

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

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: Strattera|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The symptoms of Attention Deficit Hyperactive Disorders and the prisoners use of the prisons rehabilitation services before and after treatment will be measured |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Attention Deficit Hyperactivity Disorder, treatment,, Strattera,, rehabilitation
Hemolysis in Blood Samples in the ER

Study Overview
=================
Brief Summary
-----------------
In this study, we aim to identify risk factors for hemolysis in blood samples drawn in the ED.

Conditions
-----------------
Hemolysis, Emergency Service, Hospital, Emergencies, Blood Specimen Collection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 16 years Exclusion Criteria: In vivo hemolysis

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| ED patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemolysis rate |  | 1 day |