linjc16/ctgov huggingface dataset:
Prevention of Remifentanil-induced Postoperative Hyperalgesia With Intravenous Ibuprofen

Study Overview
=================
Brief Summary
-----------------
Postoperative hyperalgesia has been reported after intraoperative administration of small or high-dose remifentanil. Cyclooxygenase inhibitor exhibit preventive effects on the development of opioid-induced hyperalgesia. The aim of this study is to evaluate the preventive effect of intravenous ibuprofen (Caldolor®) on remifentanil-induced hyperalgesia

Conditions
-----------------
Ibuprofen, Remifentanil, Hyperalgesia, Pain, Postoperative

Intervention / Treatment
-----------------
* Drug: high dose remifentanil
* Drug: Ibuprofen
* Drug: low dose remifentanil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients scheduled for elective pancreaticoduodenectomy Exclusion Criteria: Patients with chronic pain Patients with psychiatric disease Patients with nonsteroidal antiinflammatory drugs allergy Patients with renail dysfunction History of drug addiction Pregnant patient Inability to use a PCA device

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: high dose remifentanil without ibuprofen<br>remifentanil target-controlled infusion effect-site concentration 4 ng/ml normal saline before surgical incision | Drug: high dose remifentanil<br>* high dose remifentanil<br>|
| Placebo Comparator: low dose remifentanil without ibuprofen<br>remifentanil target-controlled infusion effect-site concentration 1 ng/ml normal saline before surgical incision | Drug: low dose remifentanil<br>* low dose remifentanil<br>|
| Active Comparator: high dose remifentanil with ibuprofen<br>remifentanil target-controlled infusion effect-site concentration 4 ng/ml Intravenous ibuprofen 800 mg before surgical incision | Drug: high dose remifentanil<br>* high dose remifentanil<br>Drug: Ibuprofen<br>* intravenous ibuprofen<br>|
| Active Comparator: low dose remifentanil with ibuprofen<br>remifentanil target-controlled infusion effect-site concentration 1 ng/ml Intravenous ibuprofen 800 mg before surgical incision | Drug: Ibuprofen<br>* intravenous ibuprofen<br>Drug: low dose remifentanil<br>* low dose remifentanil<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cumulative morphine consumption | cumulative patient-controlled analgesia (PCA) morphine consumption | postoperative 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | visual analogue scale | postoperative 1, 3, 6,12, 24, 48 hours Pain score |
Lyon Registry of Stroke Treated by Thrombolysis or Thrombectomy

Study Overview
=================
Brief Summary
-----------------
This observational study as an objective of characterizing the population of patients treated within the neurovascular unit of the Pierre Wertheimer hospital (Hospices Civils de Lyon) in order to determine their phenotype (age, sex, risk factors, etc.) and its evolution over time. It also aims to assess the management of ischemic stroke (IS) in the neurovascular unit of Pierre Wertheimer Hospital. We will assess in particular the pre-hospital and hospital care times, the type of medical care (thrombolysis and / or thrombectomy) as well as the efficiency of this care (effective recanalization, outcome of patient, etc.).

Detailed Description
-----------------
All patient who has had an IS with an indication of thrombolysis and / or thrombectomy, hospitalized in the neurovascular unit of Pierre Wertheimer Hospital (HCL) since January 2013 and until December 2030 will be contacted for this study

Official Title
-----------------
Lyon Registry of Stroke Treated by Thrombolysis or Thrombectomy

Conditions
-----------------
Ischemic Stroke

Intervention / Treatment
-----------------
* Biological: Registry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients over 18 years old, Hospitalization in the neurovascular unit of the Pierre Wertheimer Neurological Hospital (Hospices Civils de Lyon), Ischemic stroke treated by thrombolysis and / or mechanical thrombectomy. Exclusion Criteria: - Opposition to this research.

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 |
| --- | --- |
| Registry group<br>Patients over 18 years old, hospitalized in the neurovascular unit of the Pierre Wertheimer Neurological Hospital (Hospices Civils de Lyon), for an ischemic stroke treated by thrombolysis and / or mechanical thrombectomy and not opposed to this research | Biological: Registry<br>* No specific intervention. Data of the usual care will be collected as the medical history, the demographic data, the biological analyses, imaging report, etc.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phenotype of the population | Characterization the population of patients with stroke treated by thrombolysis and / or thrombectomy in the neurovascular unit of the Pierre Wertheimer Hospital, Hospices Civils de Lyon : age, sex, risk factors, becoming, etc. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ischemic Stroke, revascularisation therapy, registry
Changes in Sleep Patterns and Stress in Infants Entering Child Care

Study Overview
=================
Brief Summary
-----------------
When babies start day care, they experience many changes, some of which may affect their risk for sudden infant death syndrome (SIDS). The investigators want to find out if stress or change in the baby's sleep patterns can be a reason for this increased risk for SIDS.

Detailed Description
-----------------
The overall aim of this study is to describe sleep patterns in infants as they transition from home to child care, including 24-hour sleep duration, changes in the timing of daytime naps, and changes in nocturnal sleep periods; to describe potential sleep disrupters, such as temperature, light and noise, in home and child care settings that may impact sleep quality and sleep patterns; to describe markers of parent and infant stress levels during the transition to child care; to describe markers of infant circadian rhythm during the transition to child care.

Official Title
-----------------
Changes in Sleep Patterns and Stress in Infants Entering Child Care: Implications for SIDS Risk

Conditions
-----------------
Sudden Infant Death Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants who are less than 3 months of age from English-speaking families where one or both parents live in the household will be eligible to participate. If the infant will be entering child care, the infant must be entering a licensed child care center, and child care entry must be between 60 and 120 days of age. Exclusion Criteria: S/he was born prematurely, with a gestational age less than 37 weeks at birth, or had a birth weight <2500 grams (5-1/2 lbs) S/he has any medical problems that require ongoing care by a subspecialty physician

Ages Eligible for Study
-----------------
Maximum Age: 3 Months

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 |
| --- | --- |
| at home<br>Infants 0-3 months who will stay at home with a parent | |
| child care<br>Infant 0-3 months who will attend a licensed child care center | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep efficiency | sleep efficieny is defined as the ratio of time spent asleep (total sleep time) to the amount of time spent in bed. | Days -14 through +14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep duration |  | Days -14 to +14 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sudden infant death syndrome, SIDS, infant, licensed day care, sleep patterns, stress levels
Short Arc Multifidus Study

Study Overview
=================
Brief Summary
-----------------
Patients will be performing Logan short arc banding protocols to see the effect on multifidus size

Detailed Description
-----------------
The subjects will initially be scanned by diagnostic ultrasound by to assess the cross sectional area of their lumbar multifidi. Then they will perform 3 sets of 30 second periods of Logan Short Arc Banding on the ATM machine twice a week for 4 weeks and then they will be scanned again using diagnostic ultrasound to assess the effects of the rehabilitation exercise.

Official Title
-----------------
Increase in Multifidus Size By Short Arc Banding on the ATM Machine as Measure by Diagnostic Ultrasound

Conditions
-----------------
Multifidus Disuse Atrophy

Intervention / Treatment
-----------------
* Procedure: Logan Short Arc Banding


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female ages 18-54 Exclusion Criteria: Asymptomatic of: Low Back Pain, previous spinal injury, surgery or other condition affecting the spine, local infection, injury or malignancy; pregnancy or any condition affecting muscle reaction time.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 54 Years

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

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

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: Group 1<br>Group 1 wil perform short arc banding twice a week for four weeks and have diagnostic ultrasound of multifidus measured before and after intervention | Procedure: Logan Short Arc Banding<br>* Group 1 wil perform short arc banding twice a week for four weeks and have diagnostic ultrasound of multifidus measured before and after intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multifidus cross sectional area |  | 4 weeks |
Anterior Corneal Striae in Hypotony

Study Overview
=================
Brief Summary
-----------------
The goal of this is to evaluate the biomechanical properties of hypotonous eyes with vertical anterior corneal striae and/or hypotony maculopathy compared to hypotonous eyes without striae.

Official Title
-----------------
The Clinical Significance of Anterior Corneal Striae in Hypotony

Conditions
-----------------
Hypotony Ocular, Cornea Folds and Rupture of Bowman's Membrane Both Eyes, Maculopathy

Intervention / Treatment
-----------------
* Other: Ophthalmic imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects >= 18 years of age History of glaucoma History of glaucoma surgery Intraocular pressure of equal to or less than 10 mm Hg by goldmann applanation Exclusion Criteria: Coexisting ocular disease that may affect ocular biomechanics, including macular disease, corneal transplant, and uveitis

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Anterior Cornea Striae<br>Eyes with anterior cornea striae present | Other: Ophthalmic imaging<br>* Optical coherence tomography Topography Ocular Response Analyzer Optical Biometry Slit lamp photos<br>|
| Hypotony Maculopathy<br>Eyes with hypotony maculopathy present | Other: Ophthalmic imaging<br>* Optical coherence tomography Topography Ocular Response Analyzer Optical Biometry Slit lamp photos<br>|
| Hypotony only<br>Eyes with intraocular pressure less than 10 without cornea striae and/or maculopathy | Other: Ophthalmic imaging<br>* Optical coherence tomography Topography Ocular Response Analyzer Optical Biometry Slit lamp photos<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal hysteresis | Difference in postoperative corneal hysteresis (measured in mm Hg) by Ocular Response Analyzer, between study arms | Baseline | 
| Incidence of anterior corneal striae | Frequency of occurrence among all enrolled hypotonous eyes | Baseline | 
| Incidence of hypotony maculopathy | Frequency of occurrence among all enrolled hypotonous eyes | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axial length | Difference in postoperative axial length between study arms | Baseline | 
| Corneal thickness | Difference in postoperative corneal thickness between study arms | Baseline | 
| Corneal curvature | Difference in postoperative diopters of steepest cornea axis, flattest cornea axis and astigmatism between study arms | Baseline | 
| Corneal resistance factor | Difference in postoperative corneal resistance factor between study arms | Baseline |
Safety and Efficacy of VSJ-110 in the Treatment of Allergic Conjunctivitis in Adults With a History of Ocular Allergies

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and efficacy of VSJ-110 compared to placebo in the treatment of allergic conjunctivitis using an antigen challenge model

Official Title
-----------------
A Single-Center, Double-Masked, Randomized, Placebo-Controlled, Phase 2, Evaluation of the Safety and Efficacy of VSJ-110 Ophthalmic Solution in the Treatment of Allergic Conjunctivitis Using an Allergen Challenge Model

Conditions
-----------------
Allergic Conjunctivitis

Intervention / Treatment
-----------------
* Drug: VSJ-110
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age of either gender and any race Able to provide written informed consent and sign the HIPAA form Willing and able to follow all instructions and attend all study visits Exclusion Criteria: Able and willing to avoid all disallowed medications during washout and study period

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VSJ-110 Solution<br> | Drug: VSJ-110<br>* ophthalmic solution<br>|
| Placebo Comparator: Placebo Solution<br> | Drug: Placebo<br>* ophthalmic solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular itching and redness as measured by self reported or investigator assessed numerical scales | Itching will be self-reported on a 0-4 scale, with a higher number indicating more itching; redness will be assessed by the investigator on a 0-4 scale, with a higher number indicating more redness | 16 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular irritation measures such as chemosis, redness and eyelid swelling as assessed by the investigator on numerical scales | Chemosis, redness and eyelid swelling will be assessed by the investigator on a scale of 0-4, with a higher number indicating a higher intensity of the measure | 16 hours |
Pulmonary Hypertension in Lymphangioleiomyomatosis

Study Overview
=================
Brief Summary
-----------------
This is a descriptive study of patients with Lymphangioleiomyomatosis and precapillary pulmonary hypertension.

Detailed Description
-----------------
Descriptive study of patients with Lymphangioleiomyomatosis and precapillary pulmonary hypertension This will include modality of diagnosis of lLymphangioleiomyomatosis, results of right-sided heart catheterization, and pulmonary function tests

Official Title
-----------------
Observational Study of Patients With Lymphangioleiomyomatosis and Pulmonary Hypertension

Conditions
-----------------
Lymphangioleiomyomatosis, Pulmonary Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lymphangioleiomyomatosis (definite or probable), either sporadic or associated with tuberous sclerosis Precapillary pulmonary hypertension, as defined by right-sided heart catheterization (mean pulmonary artery pressure higher than 25 mmHg, wedge capillary pulmonary pressure less than 15 mmHg, pulmonary vascular resistance higher than 3 Wood units) Exclusion Criteria: Post capillary pulmonary hypertension Other identifiable causes of pulmonary hypertension (ex: thromboembolic disease) Not willing to participate

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

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

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
-----------------
Lymphangioleiomyomatosis, Pulmonary hypertension
Activity Therapy After Kidney Transplant

Study Overview
=================
Brief Summary
-----------------
To combat post-transplant weight gain, we seek to expand Stanford Kidney Transplant's multidisciplinary platform to include physical activity monitoring and coaching using the Apple Watch.

Official Title
-----------------
Activity Therapy After Kidney Transplant: A Pilot Study

Conditions
-----------------
Kidney Transplant; Complications

Intervention / Treatment
-----------------
* Device: Apple Watch Series 1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adults (18 years) who undergo kidney transplant at Stanford. Exclusion Criteria: Poor vision with inability to use Apple Watch Permanently unable to ambulate

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 |
| --- | --- |
| Experimental: Apple Watch<br>Clinic pharmacists will issue Apple Watches to study arm patients and teach them the usage of the Activity app. In addition to usual care, these patients will each receive an in-person 3-minute coaching session during clinic visit at 2, 4, 6 and 12 months. | Device: Apple Watch Series 1<br>* Clinic pharmacists will issue Apple Watches to study arm patients and teach them the usage of the Activity app. In addition to usual care, these patients will each receive an in-person 3-minute coaching session during clinic visit at 2, 4, 6 and 12 months.<br>|
| No Intervention: Usual Care<br>Usual care. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activity Level (daily caloric consumption) |  | 1 year | 
| % Days using Apple Watch |  | 1st year of transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight |  | 1st year of transplant | 
| Hemoglobin A1c |  | 1st year of transplant |
Serologic Characterization of Bone-healing

Study Overview
=================
Brief Summary
-----------------
Investigation of serologic bone markers in patients undergoing hip arthroplasty

Detailed Description
-----------------
Investigation of serologic bone markers in patients undergoing hip arthroplasty. Measured by frequent blood- and urine samples pre-operative and during the first post-operative year.

Official Title
-----------------
Serologic Based Molecular Characterization of Bone-healing After Cementless Total Hip Arthroplasty

Conditions
-----------------
Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 40-80 years

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
THA