linjc16/ctgov huggingface dataset:
Comparison of the Bispectral Index and the Entropy of the Electroencephalogram During Total Intravenous Anesthesia

Study Overview
=================
Brief Summary
-----------------
To compare Bispectral index and entropy during maintenance of anesthesia

Detailed Description
-----------------
Several monitors are currently proposed to evaluate the depth of hypnosis. Among them, Bispectral Index (BIS) is a well known and widely used parameter derived from the patient's electroencephalograph (EEG). Spectral entropy relies on the extent of disorder in both EEG and electromyography (EMG) signals and returns 2 values: State Entropy (SE) and Response Entropy. SE is computed over the frequency range of 0.8-32 Hz and reflects the level of hypnosis while Response Entropy is computed over the frequency range of 0.8-47 Hz and reflects also EMG activity. BIS and SE are dimensionless numbers scaled from 100 to 0 for BIS and from 91 to 0 for SE. The BIS and Entropy manufacturers claim that adequate level of anesthesia is defined by a BIS or SE value between 40 and 60. But some observations have shown that the monitors provided different information. These observations led us to carry out this prospective observational study designed to study the comparability between BIS and SE during the maintenance period of propofol-sufentanil anesthesia.

Official Title
-----------------
Comparison of the Bispectral Index and the Entropy of the Electroencephalogram During Total Intravenous Anesthesia

Conditions
-----------------
Anesthesia, General

Intervention / Treatment
-----------------
* Device: Bispectral index, Entropy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 years, American Society of Anesthesiologists physical status 1-3, surgery under general anesthesia using propofol, sufentanil, and a relaxant agent, surgery lasting more than one hour, tracheal extubation planned at end of surgery Exclusion Criteria: pregnant women, allergy to propofol, neurological or muscular disorder, treatment with opioids or any psychoactive medication, cardiac surgery, thyroid disorder, emergency surgery, prone or lateral decubitus position (difficulty to have a correct probe position)

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 |
| --- |
|Device: Bispectral index, Entropy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Therapeutic Touch for Wrist Fractures in Postmenopausal Women

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the effectiveness of therapeutic touch in treating wrist fractures in women past menopause.

Detailed Description
-----------------
In the United States, the use of complementary and alternative medicine (CAM) increased by approximately 25% between 1990 and 1997. The number of visits to CAM practitioners exceeded visits to primary care physicians by about 250 million in 1997. Energy medicine modalities, including therapeutic touch, healing touch, and reiki, are commonly utilized for conditions ranging from headache to cancer, yet understanding of the human energy field and how it may be used in healing is limited. This study will examine the effect of therapeutic touch on fracture healing in postmenopausal women. Women will be enrolled in the study within one week of a wrist fracture and will receive either therapeutic touch or a sham (placebo) treatment daily for 3 weeks. Assessments will include blood and urine analysis and measures of pain and function in the affected wrist.

Official Title
-----------------
The Effect of Therapeutic Touch on Bone Formation in Postmenopausal Women After Wrist Fracture

Conditions
-----------------
Osteoporosis, Fractures

Intervention / Treatment
-----------------
* Procedure: Therapeutic Touch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criertia: Postmenopausal Wrist fracture within 1 week of study entry Able to travel to research center for daily treatment

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Therapeutic Touch|nan|

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
-----------------
Bone Metabolism, Therapeutic Touch
Active Surveillance Post-Approval Atudy of the Stelkast Surpass Acetabular System

Study Overview
=================
Brief Summary
-----------------
The active surveillance post-approval study of the Stelkast Surpass Acetabular System is a retrospective, multi-center, single-arm study intended to collect data on the survivorship and long-term safety and effectiveness of the device.

Detailed Description
-----------------
This active surveillance study is intended to evaluate the survivorship and long-term safety and effectiveness of the Stelkast Surpass Acetabular System. Neither the patient nor the surgeon are blinded to treatment. The study will compare the Surpass' survivorship to the survivorship observed in a historical control group established by a meta-analysis. The evaluation will be conducted for a period of ten years. These evaluations will be recorded through onsite visits and/or mailings sent to physicians requesting deidentified patient-level data for subjects implanted with the Surpass system.

Official Title
-----------------
Active Surveillance Post-Approval Atudy of the Stelkast Surpass Acetabular System

Conditions
-----------------
Survivorship and Long-term Safety and Effectiveness of the Stelkast Surpass Acetabular System

Intervention / Treatment
-----------------
* Device: Stelkast Surpass Acetabular System implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary hip arthroplasty Skeletal maturity Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and traumatic arthritis Exclusion Criteria: The Stelkast Surpass Acetabular System is contraindicated in patients with the following conditions: Overt or latent infection in or around the hip joint, insufficient bone stock to allow appropriate insertion and fixation of the prosthesis, insufficient soft tissue integrity to provide adequate stability, muscle laxity or inadequate soft tissue for proper function and healing, mental or neuromuscular disorders that do not allow control of the affected joint, revision hip arthroplasty, inflammatory hip joint disease, and neuropathic hip joint disease.

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 |
| --- | --- |
| Stelkast Surpass Patients<br> | Device: Stelkast Surpass Acetabular System implant<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survivorship |  | 10 Years |
Protein Expression in Human Neuroblastoma Tumor Samples

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying protein expression in samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors find better ways to treat neuroblastoma. PURPOSE: This laboratory studying is looking at protein expression in tumor tissue samples from patients with neuroblastoma.

Detailed Description
-----------------
OBJECTIVES: To determine whether intersectin (ITSN1) proteins are present at elevated levels in primary human tumor samples. OUTLINE: Archived tumor tissue samples are analyzed for intersectin (ITSN1) expression by western blot assays with enhanced chemiluminescence and exposed to X-ray film. The films are scanned, and levels of ITSN1 signal are quantified by densitometry.

Official Title
-----------------
Analysis of Intersectin Expression in Primary Human Neuroblastomas

Conditions
-----------------
Neuroblastoma

Intervention / Treatment
-----------------
* Genetic: protein expression analysis
* Genetic: western blotting
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosed with neuroblastoma Banked primary tumor samples from patients with stage 1, 2, 3, and 4 disease PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: protein expression analysis|nan|
|Genetic: western blotting|nan|
|Other: laboratory biomarker analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ITSN1 is highly expressed in neuroblastoma tumors and plays an important role in the development/progression of these tumors |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
disseminated neuroblastoma, localized resectable neuroblastoma, localized unresectable neuroblastoma, stage 4S neuroblastoma
Tracheostomy and Weaning From Mechanical Ventilation : Evaluation of the Lung Ultrasound Score

Study Overview
=================
Brief Summary
-----------------
Prospective, interventional multicentric study in ICU during weaning from mechanical ventilation in tracheotomized patients

Detailed Description
-----------------
Prospective multicentric study on ICU evaluating Lung Ultrasound Score in tracheotomized patients during weaning from mechanical ventilation

Official Title
-----------------
Tracheostomy and Weaning From Mechanical Ventilation : Evaluation of the Lung Ultrasound Score

Conditions
-----------------
Tracheotomy

Intervention / Treatment
-----------------
* Procedure: Tracheotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients tracheotomised during ICU stay Consent of patients Exclusion Criteria: Tracheotomy before ICU No echogenicity

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tracheotomized patients<br> | Procedure: Tracheotomy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of lung ultrasound score |  | at day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to weaning from mechanical ventilation |  | at day 1 | 
| Length of hospital stay |  | Day 1 + 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tracheotomy, Weaning from mechanical ventilation, Lung ultrasound score
A Study of Azithromycin in HIV-Infected Patients

Study Overview
=================
Brief Summary
-----------------
To assess the dose proportionality of azithromycin concentrations and toleration when delivered in tablet formulation to HIV-infected patients. The need exists to further assess the antibacterial agent azithromycin at differing doses in an HIV-infected population.

Detailed Description
-----------------
The need exists to further assess the antibacterial agent azithromycin at differing doses in an HIV-infected population. Patients are randomized to receive azithromycin at 1 of 2 doses in a two-treatment, two-period, cross-over study. Dosing visits are separated by at least 14-day wash-out periods.

Official Title
-----------------
Double-Blind Crossover Study Assessing the Dose Proportionality of Azithromycin Tablets in HIV-Infected Subjects

Conditions
-----------------
Bacterial Infections, HIV Infections

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: HIV seropositivity. CD4 count <= 500 cells/mm3. NO active AIDS opportunistic infection. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Other active intercurrent illness. Any condition possibly affecting drug absorption (e.g., ulcers, gastrectomy, HIV-associated enteropathies. Signs or symptoms of severe illness that would preclude study participation. Known allergies to macrolide antibiotics. Patients with the following prior condition are excluded: Clinically important change in baseline status within 4 weeks prior to study entry. Prior Medication: Excluded: Investigational drugs including treatment IND drugs within 4 weeks prior to study entry. Known drug or alcohol dependence.

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
Intervention Model: Parallel Assignment


Arms and Interventions

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

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
-----------------
Azithromycin, Bacterial Infections
Thyroid Functions in Children With Congenital Heart Diseases

Study Overview
=================
Brief Summary
-----------------
Thyroid hormone is critical for normal neurocognitive development in young infants, and even transient hypothyroidism can cause adverse neurodevelopmental outcomes. In a population of infants with CHD who already bear a high risk of long-term developmental delay, detection of hypothyroidism, even of a transient nature, may be even more consequential, and routine periodic monitoring of thyroid function may be necessary to reduce the risk of neurodevelopmental disabilities

Official Title
-----------------
Thyroid Functions in Children With Congenital Heart Diseases

Conditions
-----------------
Value of Thyroid Functions in Children With Congenital Heart Diseases

Intervention / Treatment
-----------------
* Diagnostic Test: T3-T4-TSH


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All children since birth up to age of 12 years old including both genders diagnosed to have CHD exposed to radiation, contrast or not. Exclusion Criteria: above 12 years old

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 12 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A: children exposed to any type of radiation or contrast<br>Group A: children exposed to any type of radiation or contrast | Diagnostic Test: T3-T4-TSH<br>* thyroid function tests<br>|
| Group B : children not exposed to an type of radiation or contrast<br>Group B : children not exposed to an type of radiation or contrast | Diagnostic Test: T3-T4-TSH<br>* thyroid function tests<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of thyroid function in children with congenital heart diseases at Sohag University hospital | Thyroid function tests will be obtained from children with congenital heart diseases as will as the control group | One year |
Psoas Compartment Block Versus Fascia Iliaca Block After Total Hip Arthroplasty

Study Overview
=================
Brief Summary
-----------------
A psoas compartment block has been used with good results for postoperative pain relief after total hip arthroplasty (THA). However, case reports describing serious complications after the use of this block, have been reported. The fascia iliaca compartment block (FICB) has been shown to be a reliable block for postoperative pain relief for procedures and injuries involving the hip. The investigators have not found any literature that has compared these two blocks. This study will compare the two blocks when used for post-operative pain relief after THA.

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Bupivacaine
* Drug: Morphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA Class I-III Patients undergoing THA for osteoarthritis Exclusion Criteria: Skin infections adjacent to block site Allergy to local analgesics Patient unable to understand visual analogue scale (VAS)

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 90 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: PsCB Group<br>Ultrasound-Guided Psoas Compartment Block will be used in patients for pain relief after THA | Drug: Bupivacaine<br>* Bupivacaine 0.5% with adrenaline 5 mcg/cc<br>|
| Active Comparator: FICB Group<br>Ultrasound-Guided Fascia Iliaca Compartment Block will be used in patients for pain relief after THA | Drug: Bupivacaine<br>* Bupivacaine 0.5% with adrenaline 5 mcg/cc<br>|
| Active Comparator: Patient-Controlled Analgesia<br>Patient-controlled analgesia will be used for pain relief after THA | Drug: Morphine<br>* Morphine 1 mg/cc<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score of patients who have been given FICB for post-operative pain relief after THA |  | 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain score
Follow up of Patients After a Visit to Tourcoing Emergency Department for an Ankle Sprain

Study Overview
=================
Brief Summary
-----------------
Ankle sprain is very common. In France, its daily incidence is estimated at 6000. It often causes pain, a temporary period of disability and can results in recurrence and chronic ankle instability. Therefore, an early management and follow up treatment is necessary. Now, functional treatment is clinically the treatment strategy of choice for ankle sprain. It is based on rest, ice, compression, elevation and can use a functional support (like an ankle brace). To evaluate gravity and improve management, a clinical assessment delayed between 4 and 5 days post injury is necessary.

Official Title
-----------------
Follow up of Patients After a Visit to Tourcoing Emergency Department for an Ankle Sprain

Conditions
-----------------
Ankle Sprains

Intervention / Treatment
-----------------
* Other: questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consulted for ankle trauma as primary reason Agreeing to participate in the telephone survey 6 weeks after trauma Affiliation in a social security scheme Exclusion Criteria: Patients deprived of liberty Patients with an unbalanced psychiatric disease If consultation delayed 48 hours due to trauma Patients with fracture Patients with Chopart or Lisfranc injury Pregnant women People who do not speak French

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 55 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: questionnaires|6 weeks after the trauma,during the call, an oral questionnaire will be proposed to collect data on patients' management since they have left the emergency department. After the call, socio-demographic characteristics, trauma mechanism, medics management will be extracted from the patient's medical records|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients who received a five days post injury new clinical assessment |  | at 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral questionnaires | The questionnaire will ask questions around their socio-demographic characteristics, trauma mechanism, medics management since they have left the emergency department. | At 6 weeks | 
| Rate of patients receiving physiotherapy |  | At 6 weeks | 
| Rate of patients with recurrence |  | At 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
inversion trauma, Ankle sprain, physical examination, therapy, recurrence