linjc16/ctgov huggingface dataset:
Continuous Infusion for Pain Relief

Study Overview
=================
Brief Summary
-----------------
SPINAL anesthesia is commonly used for cesarean section, and it has become a popular practice to add opioids to spinal solutions to enhance and prolong intraoperative and postoperative analgesia. high incidence of side effects was noted. is there any alternative?

Official Title
-----------------
Comparaison of Continuous Infusion of Local Anesthetic and Intrathecal Morphine for Pain Management in Elective Caeserean Section

Conditions
-----------------
Regional Anesthesia, Caeserian Section, Local Anesthetic

Intervention / Treatment
-----------------
* Drug: control group
* Drug: infiltration group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA physical status I-II 18-45 years of age, inclusive elective caeserean section under spinal anesthesia Exclusion Criteria: - contraindications to spinal anesthesia (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the area) existing neurological deficit inability to understand the informed consent and demands of the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control group<br> | Drug: control group<br>* spinal anesthesia with 10 mg hyperbaric Bupivacaïne 0,5% + 2,5 µ Sufentanyl + 100 µ of intrathecal Morphine+ infiltration catheter with saline 5 ml/h<br>Drug: infiltration group<br>* spinal anesthesia with 10 mg hyperbaric Bupivacaïne 0,5% + 2,5 µ Sufentanyl + 1ml of saline + infiltration catheter with 5 ml/h of Bupivacaïne 0,125%.<br>|
| Active Comparator: infiltration group<br> | Drug: control group<br>* spinal anesthesia with 10 mg hyperbaric Bupivacaïne 0,5% + 2,5 µ Sufentanyl + 100 µ of intrathecal Morphine+ infiltration catheter with saline 5 ml/h<br>Drug: infiltration group<br>* spinal anesthesia with 10 mg hyperbaric Bupivacaïne 0,5% + 2,5 µ Sufentanyl + 1ml of saline + infiltration catheter with 5 ml/h of Bupivacaïne 0,125%.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogic Scale | quality of postoperative analgesia | until 48 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of complications |  | 48 hours post operative | 
| total dose of morphine consumption in mg |  | during 48 hours post operative |
Reasons for Mycophenolate Mofetil Dose Reduction and Impact on Graft Outcome in Renal Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
Mycophenolate mofetil (MMF) decreases the risk of acute rejection and is associated with improved graft survival in renal transplant recipients. However, MMF-related side effects often necessitate dose reduction which may expose transplant recipients to a higher risk of acute rejection and graft loss. This study's aim was to examine the reasons for MMF dose reduction during the first year after kidney transplantation and its impact on acute rejection, overall and death-censored graft loss. Methods: Retrospective electronic file based analysis of all patients who underwent a single kidney transplantation in our center between 1996 and 2007 and were treated with MMF as part of their initial maintenance immunosuppressive protocol (n=749).

Official Title
-----------------
Reasons for Dose Reduction of Mycophenolate Mofetil During the First Post-transplant Year in Renal Transplant Recipients and Its Impact on Graft Outcome: a Single-center Retrospective Analysis

Conditions
-----------------
Acute Rejection of Renal Transplant, Renal Graft Loss

Intervention / Treatment
-----------------
* Other: no intervention, this is an observational retrospective trial


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who received a single renal transplant at the University Hospitals of Leuven between April 1996 (when MMF was introduced in the Leuven renal transplant program) and February 2007 and were treated with MMF (Cellcept®, Roche) as part of their initial maintenance immunosuppressive regimen were included in this retrospective analysis. Exclusion Criteria: If a patient underwent more than one kidney transplantation in the abovementioned 11-year period, only the last was considered.

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 |
| --- | --- |
| renal transplantation with MMF from day 1<br> | Other: no intervention, this is an observational retrospective trial<br>* no intervention, this is an observational retrospective trial<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reasons for dose reduction of MMF |  | 400 days post-transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurence of acute rejection |  | 400 days post-transplantation | 
| graft survival |  | 400 days post-transplantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
reasons for MMF dose reduction
Efficacy of Cortex Stimulation in Neuropathic Pain

Study Overview
=================
Brief Summary
-----------------
The pains chronic neurogeneses remain difficult to treat whatever are their origin and their localization. The pharmacological therapeutic arsenal answers only partially the symptomatology often very invalidating which these chronic painful patients present. Electric stimulations of the central nervous system currently validated, in particular of the posterior cords of marrow made a significant improvement in a certain number of indications. Nevertheless, considerable patients are not relieved significantly, in particular those presenting of the pains neurogeneses of central origin (syndromes thalamic for example). It is within this framework that recently the stimulation of the sensorimotor cortex developed. Principal objective: evaluation of the technique of stimulation under cortical on neuropathic pains .

Detailed Description
-----------------
The pains chronic neurogeneses remain difficult to treat whatever are their origin and their localization. The pharmacological therapeutic arsenal answers only partially the symptomatology often very invalidating which these chronic painful patients present. Electric stimulations of the central nervous system currently validated, in particular of the posterior cords of marrow made a significant improvement in a certain number of indications. Nevertheless, considerable patients are not relieved significantly, in particular those presenting of the pains neurogeneses of central origin (syndromes thalamic for example). It is within this framework that recently the stimulation of the sensorimotor cortex developed.

Official Title
-----------------
Evaluation of the Effectiveness of Stimulation Cortex Sensorimotor for the Treatment of Rebel Neuropathic Pains

Conditions
-----------------
Rebel Neuropathic Pains

Intervention / Treatment
-----------------
* Device: Cortex stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neurofibromatosis, Rebel chronic neuropathic pain with duration > 1 year and AVS > = 4 Exclusion Criteria: Cancer Epilepsy Cognitive deterioration

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: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Cortex stimulation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of 50% of EVS at 3 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of 50% of EVS at 6 months and 12 months |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cortex stimulation ,Rebel neuropathic pains
A Clinical Investigation of Recovery Following Hip Resurfacing or Total Hip Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to compare early functional outcomes in patients undergoing hip resurfacing and total hip arthroplasty with the M2a-Magnum™ using more objective measures of function.

Official Title
-----------------
Functional Recovery Following Hip Resurfacing or Total Hip Arthroplasty in Patients Matched By Age, Gender, and Activity Level

Conditions
-----------------
Osteoarthritis, Rheumatoid Arthritis, Arthritis, Traumatic Arthritis

Intervention / Treatment
-----------------
* Device: Hip Resurfacing System
* Device: M2a-Magnum™ Large Metal Articulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients requiring hip arthroplasty Exclusion Criteria: Patients with sensory, neurological, or general health conditions that alter perception of their limb in space Patients with vestibular disorders

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br> | Device: Hip Resurfacing System<br>* This arm will utilize a hip resurfacing system.<br>|
| Other: 2<br> | Device: M2a-Magnum™ Large Metal Articulation<br>* This arm will utilize the M2a-Magnum™ implant system.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Tests |  | 1 year |
Knowledge, Attitudes, and Practice of Surgeons Toward Nutrition Support in HIPEC Patients

Study Overview
=================
Brief Summary
-----------------
The goal of this survey of international HIPEC (Hyperthermic Intraperitoneal Chemotherapy) surgeons is to determine their knowledge of and attitudes towards the nutritional support needs of HIPEC patients and what their practice patterns are with this patient population.

Official Title
-----------------
A Survey of the Knowledge, Attitudes, and Practice of Surgeons Toward Nutrition Support in HIPEC Patients

Conditions
-----------------
Sarcoma, Pseudomyxoma Peritonei, Appendiceal Neoplasms, Pancreatic Neoplasms, Neoplasm Metastasis, Adenocarcinoma, Uterine Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Surgeon trained in and performing the HIPEC procedure Exclusion Criteria: Not performing the HIPEC procedure
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIPEC surgeons<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collect questionnaire data from 150 HIPEC surgeons | Questionnaire development was informed by the works of: Karim et al, JPEN 2014 Mar 3, [Epub ahead of print]; Cahill, et al, Critical Care 2014, 18:R96; Vashi et al, Nutrition Journal 2013, 12:118; and Cahill et al, BMC Health Services Research 2014, 14:197. | Three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIPEC surgeon practices of patient nutritional support assessed by questionnaire | Questionnaire development was informed by the works of: Karim et al, JPEN 2014 Mar 3, [Epub ahead of print]; Cahill, et al, Critical Care 2014, 18:R96; Vashi et al, Nutrition Journal 2013, 12:118; and Cahill et al, BMC Health Services Research 2014, 14:197. | Three months | 
| HIPEC surgeon attitudes toward patient nutritional support self-assessed by questionnaire | Questionnaire development was informed by the works of: Karim et al, JPEN 2014 Mar 3, [Epub ahead of print]; Cahill, et al, Critical Care 2014, 18:R96; Vashi et al, Nutrition Journal 2013, 12:118; and Cahill et al, BMC Health Services Research 2014, 14:197. | Three months |
Parathyroid Reimplantation in Forearm Subcutaneous Tissue During Thyroidectomy: a Simple Way to Avoid Ipoparathyroidism and Evaluate Graft Function

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate safety and effectiveness of normal parathyroid tissue reimplantation in forearm subcutaneous tissue in case of accidental removal of parathyroid gland during thyroid surgery.

Official Title
-----------------
Arathyroid Reimplantation in Forearm Subcutaneous Tissue During Thyroidectomy: a Simple Way to Avoid Ipoparathyroidism and Evaluate Graft Function

Conditions
-----------------
Thyroid Goiter, Thyroid Carcinoma, Multinodular Goiter, Graves Diseases

Intervention / Treatment
-----------------
* Procedure: Thyroidectomy and parathyroid reimplantation in forearm subcutaneous tissue


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients affected by benign thyroid disease undergoing thyroidectomy
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Parathyroid reimplantation<br> | Procedure: Thyroidectomy and parathyroid reimplantation in forearm subcutaneous tissue<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of parathyroid tissue graft function by selective (left or right) parathormone measurement by vein blood sample | The primary outcome will be the assessment of reimplanted parathyroid function, evaluated by intact Parathormone (iPTH) measurement by separate blood samples (left and right arm) at 7 days, 1 month and 3 months after surgery. Ratio of 1.5 between the iPTH levels in the arm receiving graft and the opposite arm will be predictive of graft functionality | up to 3 months |
Transcranial Magnetic Treatment (TMS) in Unipolar Depression

Study Overview
=================
Brief Summary
-----------------
Repetitive Transcranial Magnetic Stimulation (rTMS) can improve mood and decrease sadness in patients with depression. In this study, the investigators seek to increase their understanding about how rTMS improves depression, and to determine which form of rTMS is most effective for depression, when used in combination with antidepressant medication.

Detailed Description
-----------------
Patients will be assigned for 4 treatment arms, receiving either left high frequency plus right low frequency, or left high frequency plus right sham, or left sham, plus right low frequency, or left sham plus right sham treatment. All subjects will receive treatments for 10 days and will be followed for another 4 weeks.

Official Title
-----------------
Repetitive Transcranial Magnetic Stimulation (rTMS) in Unipolar Depression

Conditions
-----------------
Unipolar Depression

Intervention / Treatment
-----------------
* Procedure: Transcranial Magnetic Stimulation (TMS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major Depression No physical health problems Exclusion Criteria: History of Epilepsy Metal in the head/neck or skull Pacemaker Pregnancy

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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Transcranial Magnetic Stimulation (TMS)|treatment for 10 days|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Rating Scale |  | Pre TMS and post TMS | 
| Beck Depression Rating Scale |  | pre TMS and post TMS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitive Electroencephalographic(QEEG)activity and measures of regional cerebral blood flow |  | pre TMS and post TMS as well as post phase II, second set of TMS | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Repetitive Transcranial Magnetic Stimulation, TMS
Transperineal Ultrasound for the Female Pelvic Floor in Women With Multiple Gestation

Study Overview
=================
Brief Summary
-----------------
This trial studies the effect of pregnancies of multiple gestations (i.e. twins, triplets etc.) on the female pelvic floor with regards to the pregnancy itself and labor and delivery mode, by using transperineal ultrasound. This will be compared with pregnancies with single fetuses.

Detailed Description
-----------------
This trial studies the effect of pregnancies of multiple gestations (i.e. twins, triplets etc.) on the female pelvic floor with regards to the pregnancy itself and labor and delivery mode, by using transperineal ultrasound. This will be compared with pregnancies with single fetuses. See study protocol.

Official Title
-----------------
Prospective Follow up of the Female Pelvic Floor in Multiple Gestation Using Transperineal Ultrasound

Conditions
-----------------
Multiple Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with multiple gestations Women with singleton gestation Able to understand the consent form Exclusion Criteria: None specified

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 60 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 |
| --- | --- |
| 1 study group<br>Women with multiple gestations recruited from the prenatal care or high risk pregnancy units | |
| 2 control group<br>Women with singleton gestation recruited from the prenatal care or high risk pregnancy units | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multiple gestation affects the pelvic floor more than singleton gestation |  | Until recruitment completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mode of delivery affects pelvic floor outcome |  | As above | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pelvic floor, Transperineal ultrasound, Multiple pregnancy, Singleton pregnancy, Female pelvic floor
The Effect of Femoral Nerve Block on Opioid Requirements After Surgery for a Femur Fracture in Children

Study Overview
=================
Brief Summary
-----------------
This study evaluates the effect of a femoral nerve block on opioid requirements following femoral fracture fixation with flexible nails in the paediatric population. This is a double blind, prospective randomized clinical trial.

Official Title
-----------------
The Effect of Femoral Nerve Block on Opioid Requirements Following Femoral Fracture Fixation With Flexible Nails in the Paediatric Population: A Double Blind, Prospective Randomized Clinical Trial

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Procedure: Administration of a femoral nerve block (bupivacaine HCL)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Femoral shaft fracture requiring intra-medullary nailing Surgery performed within 24 hours of injury Ability of child or family to use patient-controlled analgesia (PCA) No allergy or sensitivity to bupivacaine Informed consent and assent Exclusion Criteria: Open femur fractures Closed fractures needing open reduction Fractures associated with neurovascular complications Fractures associated with compartment syndrome Repeat femoral surgeries Patients who received a femoral nerve block more than 1 hour prior to surgery Complex associated injuries or pre-existing condition that will delay time to ambulation Children who are allergic and/or sensitive to bupivacaine

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Administration of a femoral nerve block (bupivacaine HCL)|No details specified|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative morphine requirement; the average 8 hour morphine requirement (mcg/kg/hr) will be recorded |  | until patient discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain rating |  | immediately post-op | 
| Sedation/pruritis/nausea/vomiting/urinary retention/respiratory rate |  | every 8 hours | 
| Time to discharge |  | from end of surgery | 
| Time (hours) from end of surgery to sitting on bed with legs hanging over the side |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Femur fracture, morphine sparing, preemptive analgesia, Post-operative pain and post- operative opioid use