linjc16/ctgov huggingface dataset:
Pain Study Using Intermittent Bupivacain Injections After Breast Reconstruction With DIEP Flap

Study Overview
=================
Brief Summary
-----------------
patients are given bupivacain intermittent locally on the donor site after brest reconstruction with diep flap. The hypothesis was that this approach will reduce the need for rescue analgetic medication and pain perception within the three first days

Official Title
-----------------
Improved Pain Relief Using Intermittent Bupivacain Injections at the Donor Site After Breast Reconstruction With Deep Inferior Epigastric Artery Perforator (DIEP) Flap

Conditions
-----------------
Breast Reconstruction

Intervention / Treatment
-----------------
* Drug: bupivacain
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients planned to undergo reconstructive breast surgery with a DIEP Exclusion Criteria: regular use of analgesics known allergic reaction to bupivacain bleeding disorders pregnancy
Sexes Eligible for Study
-----------------
Female

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 bupivacain<br> | Drug: bupivacain<br> <br> |
| Placebo Comparator: 2 placebo<br> | Drug: placebo<br> <br> |

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
-----------------
bupivacain, breast, reconstruction, diep, pain, postoperative, catheter, anesthesia
The Impact of RPh201 on Chronic Vegetative State (CVS): fMRI Study

Study Overview
=================
Brief Summary
-----------------
The aim is to evaluate the impact of RPh201 on brain activity in chronic vegetative state patients. The assessment will be done using clinical measurements and functional MRI studies.

Official Title
-----------------
Phase 1 Study of RPh201 in Patients With Chronic Vegetative or Minimal Conscious State

Conditions
-----------------
Chronic Vegetative State

Intervention / Treatment
-----------------
* Drug: RPh201
* Drug: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic vegetative state patients Exclusion Criteria: allergic reaction to treatment patients that can not undergo MRI Pregnancy

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RPh201 group<br>7 patients will receive the treatment | Drug: RPh201<br>* 400 microliter s.c. twice a week for 3 months<br>|
| Placebo Comparator: non RPh201 group<br>3 patients will receive placebo | Drug: Saline<br>* 400 microliter Saline solution s.c. twice a week for 3 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| consciousness level measured clinically | Each patient will undergo a behavioral assessment (using the Coma Recovery Scale Revised) before treatment and every 2 weeks during the treatment period as well as 3 months following the end of the treatment. Complete blood counts, electrolytes, liver function tests, renal function tests and ECG will be performed every two weeks. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional magnetic resonance imaging of cortical activity | 3 scans will be performed: before treatment, after three months of treatment and 3 months after cessation of treatment. Scanning sessions will include a hierarchical auditory paradigm, an imagery task and resting state fMRI | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic vegetative state, functional MRI
Intrastromal Corneal Ring for Ectasia After Refractive Surgery (Anel)

Study Overview
=================
Brief Summary
-----------------
To evaluate the clinical outcomes of intrastromal corneal ring segment (ICRS) implantation to correct keratoconus on eyes with prior refractive surgery.

Detailed Description
-----------------
Forty-two eyes of 26 patients, 14 men and 12 women, with ectasia after refractive surgery were studied in a nonrandomized, retrospective, observational case series. Mean age at the time of ICRS implantation was 30,5 years.

Official Title
-----------------
Intrastromal Corneal Ring Segment Implantation for Ectasia After Refractive Surgery

Conditions
-----------------
Ectasia

Intervention / Treatment
-----------------
* Procedure: INTRASTROMAL CORNEAL RING SEGMENT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 19 to 48 years old Keratoconus (ectasia) on eyes with prior refractive surgery Exclusion Criteria: Diabetes Autoimmune diseases

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 48 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 |
| --- | --- |
| INTRASTROMAL CORNEAL RING SEGMENT<br>Forty-two eyes of 26 patients, 14 men and 12 women, with ectasia after refractive surgery were studied in a nonrandomized, retrospective, observational case series. | Procedure: INTRASTROMAL CORNEAL RING SEGMENT<br>* Corneal tunnels were created by means of mechanical dissection in all eyes. Main outcome measures included UCVA, BCVA, refraction, keratometry and computerized analysis of corneal topography.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intrastromal Corneal Ring Segment Implantation for Ectasia After Refractive Surgery | To evaluate the clinical outcomes of intrastromal corneal ring segment (ICRS) implantation to correct keratoconus on eyes with prior refractive surgery. Corneal tunnels were created by means of mechanical dissection in all eyes. Main outcome measures included UCVA, BCVA, refraction, keratometry and computerized analysis of corneal topography. | Mean follow-up after ICRS implantation was 12 months (range, 09 to 22 months). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
INTRASTROMAL CORNEAL RING, ASTIGMATISM
The Pharmacokinetics of Azithromycin Prophylaxis for Cesarean Delivery

Study Overview
=================
Brief Summary
-----------------
PKAZ is a single institution study designed to evaluate the optimal dosing parameters for azithromycin for pre-surgical cesarean prophylaxis. Hypothesis: Pre-operative administration of azithromycin results in maternal and neonatal tissue concentrations that adequately treat microbes commonly involved in post-cesarean infections.

Official Title
-----------------
The Pharmacokinetics of Azithromycin Prophylaxis for Cesarean Delivery

Conditions
-----------------
Endometritis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women 19 years and older Term (37 weeks and greater) Singleton gestation Scheduled cesarean section Non-laboring Intact membranes Exclusion Criteria: < 19 years of age Preterm (< 37 weeks) Multifetal gestation Laboring or ruptured membranes Known fetal anomaly Oligo- or polyhydramnios Macrolide allergy Macrolide exposure within 2 weeks Medical co-morbidities Hepatic or renal impairment Taking medications that prolong the QT interval Currently taking nelfinavir, efavirenz, or flucanozole Structural heart defects or arrythmia

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 15 minutes<br>500 mg of intravenous azithromycin will be administered 15 minutes prior to incision. | Drug: Azithromycin<br>* 500 mg intravenous infused over 1 hour<br>* Other names: Zmax;|
| 30 minutes<br>500 mg of intravenous azithromycin will be administered 30 minutes prior to incision. | Drug: Azithromycin<br>* 500 mg intravenous infused over 1 hour<br>* Other names: Zmax;|
| 60 minutes<br>500 mg of intravenous azithromycin will be administered 60 minutes prior to incision. | Drug: Azithromycin<br>* 500 mg intravenous infused over 1 hour<br>* Other names: Zmax;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients in Each Group That Attain an Adequate Azithromycin Concentration | The primary outcome of this study will be the number of patients in each group that attain an azithromycin concentration in the various maternal and fetal tissues at least equivalent to the MIC 90 for common organisms involved in post-cesarean infections. | 48 hours after delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pregnancy, Cesarean section, Antibiotic
Acceptance Of A Partially-Hydrolyzed Infant Formula

Study Overview
=================
Brief Summary
-----------------
This clinical trial will evaluate stool consistency in infants receiving one of two study formulas through a 14-day feeding period.

Official Title
-----------------
Acceptance Of A Partially-Hydrolyzed Infant Formula

Conditions
-----------------
Stool

Intervention / Treatment
-----------------
* Other: Control
* Other: Investigational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton 28-300 days of age at randomization Gestational age less than or equal to 35 weeks Receiving minimum 18oz infant formula in the 24hrs prior to randomization History of hard stools or stooling difficulty Signed informed consent and protected health information Exclusion Criteria: Current diagnosis of cow's milk protein allergy or intolerance Use of extensively hydrolyzed or amino acid formula at randomization Any abdominal or gastrointestinal surgery prior to randomization History of underlying metabolic or chronic disease or congenital malformation Organic causes of constipation

Ages Eligible for Study
-----------------
Minimum Age: 28 Days
Maximum Age: 300 Days

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br> | Other: Control<br>* Routine cow's milk-based infant formula<br>|
| Experimental: Investigational<br> | Other: Investigational<br>* Partially-hydrolyzed cow's milk protein infant formula<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool consistency measured by MJN stool consistency scale |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool frequency |  | 14 days | 
| Formula acceptance measured by intake diary |  | 14 days | 
| Formula gastrointestinal tolerance measured by diary |  | 14 days | 
| Bowel movement characteristics by diary |  | 14 days | 
| Medically confirmed adverse events throughout the study period |  | 14 days |
Type 3 Predictive Observational Study for Sensory Profiles in Central Sensitization in Low Back Pain Population.

Study Overview
=================
Brief Summary
-----------------
This study conducts prognostic research to develop, validate, and evaluate the predictive role of sensory profiles in the development of sensory profiles over time. Therefore, a type 3 prognostic model research will be conducted in the low back pain population.

Detailed Description
-----------------
This is a longitudinal multi-centre prospective cohort study design with two measurements.The STROBE statement is used as guideline and the results are reported according to the TRIPOD, and REMARK checklists. The study is a type III prognostic model research study, following the PROGRESS framework to assess the outcome by the development, validation, and evaluation of the impact of incorporating single or multiple prognostic factors, and their prognostic value at baseline in the development of CS over a period of 12 weeks.

Official Title
-----------------
Type III PROGRESS Framework for Prognosis Research: Building Prognostic Models for Sensory Profiles in the Development of Central Sensitisation in the Chronic Low Back Pain Population

Conditions
-----------------
Sensory Profiles, Nociplastic Pain, Low Back Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with acute LBP (< six weeks) with or without radiating pain aged 18 to 60 years a pain-free episode for at least 12 weeks before the onset of their current back pain. be able to read and understand the Dutch language. Exclusion Criteria: any specific cause of low back pain

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| t0, t1<br>acute low back pain, inclusion criteria. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central Sensitization Inventory | Central Sensitization Inventory (CSI) is a questionnaire which consists of 2 parts. Part A measures 25 symptoms on a 5-point scale, scoring ranges from 0-4, with a total on an ordinal scale ranging from 0-100. Part B records the presence diagnosed central sensitization syndromes, on a nominal scale. Four factors with excellent internal consistency (Cronbach's alpha= 0.91) can be identified: disability and physical symptoms; higher central sensitivity; urological and dermatological symptoms and emotional distress. The CSI has an excellent test-retest reliability of ICC=0.88 in chronic low back pain populations. | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sensory profiles, central sensitization, low back pain.
Accuracy of Maxillary Repositioning With bi or Tripartite Disjonction by Virtual Planning in Orthognathic Surgery Using Patient-specific Titanium Plates

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to assess the accuracy of computer-aided orthognathic surgery and patient specific titanium plates for maxillar osteotomy with bi or tripartite disjonction in 22 patients who underwent bimaxillar osteotomy for occlusal trouble.

Official Title
-----------------
Accuracy of Maxillary Repositioning With bi or Tripartite Disjonction by Virtual Planning in Orthognathic Surgery Using Patient-specific Titanium Plates : a Case Series

Conditions
-----------------
Occlusal Trauma

Intervention / Treatment
-----------------
* Procedure: bimaxillair osteotomy with maxillar segmentation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - bimaxillar osteotomy with maxillar segmentation and full imageries . Exclusion Criteria: None

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

| Intervention/Treatment |
| --- |
|Procedure: bimaxillair osteotomy with maxillar segmentation|Patients who underwent bimaxillair osteotomy with maxillar segmentation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| accuracy of patient-specific surgical guides and plates in maxillary repositioning with bi or tri-partite disjonction | Error (in millimeters) in repositionning the maxilla comaring 3D-plannification skulls and post-operative CBCT | 2 months |
Natural History of Hepatitis C in Patients With Normal Liver Tests

Study Overview
=================
Brief Summary
-----------------
The Major goals of this project was to assess the natural history of disease in chronic hepatitis C patients with normal ALT and to determine the virologic and host factors associated with disease severity.

Official Title
-----------------
Determinants of Disease Severity in Patients With Chronic Hepatitis C and Normal Serum Aminotransferases (Normal Liver Tests)

Conditions
-----------------
Chronic Hepatitis C

Intervention / Treatment
-----------------
* Procedure: liver biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with chronic hepatitis C and persistently normal liver enzymes able to give consent Exclusion Criteria: decompensated liver disease any prior antiviral or immunosuppressive therapy other liver disease besides hepatitis C

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

| Intervention/Treatment |
| --- |
|Procedure: liver biopsy|Liver biopsy every 5 years|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ALT |  | March 2015 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HCV, hepatitis C, natural history
Quantitative Non-Invasive Brain Imaging Using QUTE-CE MRI

Study Overview
=================
Brief Summary
-----------------
This trial will evaluate a non-invasive brain imaging technique QUTE-CE MRI and validate the method with first-in-human studies.

Detailed Description
-----------------
This trial will evaluate a non-invasive brain imaging technique QUTE-CE MRI using Ferumoxytol as a contrast agent, and validate the method with first-in-human studies. Subjects who are already scheduled to receive ferumoxytol infusion will undergo MRI scans after the infusion. The ferumoxytol infusion itself is not a part of the study. The project will provide brain angiograms and establish a human cerebrovascular atlas that will enable future quantitative diagnosis of cerebrovascular abnormalities by revealing abnormal regions of the brain that characterize disease, a tool which doesn't currently exist, and which could lead to many exciting discoveries and clinical applications in neurology.

Official Title
-----------------
Quantitative Non-Invasive Brain Imaging Using QUTE-CE MRI

Conditions
-----------------
Cerebrovascular Disorders

Intervention / Treatment
-----------------
* Diagnostic Test: Quantitative Magnetic Resonance Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between the ages of 18 to 80; Able to understand written consent document and HIPAA authorization prior to initiation of study related procedures. Exclusion Criteria: Known allergy to ferumoxytol or any intravenous iron preparation; Iron saturation above the upper limit of normal; Individuals with a contraindication to MRI, such as the presence of metallic prostheses or implanted metal device (e.g., infusion pump, defibrillator); Individuals with known clinical conditions that may lead to iron overload including hemochromatosis, cirrhosis, or sickle cell disease; Individuals with any serious medical condition that the investigator believes may place them at increased risk for an adverse event.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Quantitative Magnetic Resonance Imaging|Radiological diagnosis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebrovascular Angiography | Obtain angiograms of the cerebral vasculature from the MRI intensity data | 0-4 hours after ferumoxytol infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative cerebral blood volume atlas | Create cerebral blood volume atlas from the quantitative MRI intensity data | 0-4 hours after ferumoxytol infusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Magnetic Resonance Imaging, Ferumoxytol