linjc16/ctgov huggingface dataset:
Effects of Augmented Renal Clearance on Pharmacokinetic and Pharmacodynamic Properties of Levetiracetam in Subarachnoid Hemorrhage

Study Overview
=================
Brief Summary
-----------------
This study evaluates the pharmacokinetic profile of levetiracetam in critically ill patients who have suffered a subarachnoid hemorrhage. The patients will be evaluated for development of augmented renal clearance and the effects and duration of effects this may have on levetiracetam clearance.

Official Title
-----------------
Effects of Augmented Renal Clearance on Pharmacokinetic and Pharmacodynamic Properties of Levetiracetam in Subarachnoid Hemorrhage

Conditions
-----------------
Subarachnoid Hemorrhage

Intervention / Treatment
-----------------
* Other: Pharmacokinetic modeling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with non-traumatic subarachnoid hemorrhage requiring levetiracetam for seizure prophylaxis or treatment Presentation to University of Colorado Hospital within 48 hours of subarachnoid hemorrhage Adults ages 18 to 89 years Anticipated length of stay ≥ 48 hours Informed consent provided by the patient or patient's designated medical proxy Exclusion Criteria: Pregnancy Patients receiving renal replacement therapy Brain death or imminent brain death expected ≤48 hours Patient with history of nephrectomy or renal transplant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 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 |
| --- | --- |
| Subarachnoid Hemorrhage<br> | Other: Pharmacokinetic modeling<br>* Timed blood draws and urine collections to model drug clearance<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in systemic levetiracetam clearance over time | calculated systemic levetiracetam clearance (based on plasma concentrations) within 48 hours of initial presentation to the neurointensive care unit and every 5 days thereafter up to 20 days | 0-20 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in urinary clearance of levetiracetam and creatinine | 12-hour urine collections on day 0, 5, 10, 15, and 20, calculated creatinine based on 12-hour urine collections daily for 7 days following diagnosis of vasospasm, and calculation of direct renal clearance of levetiracitam based on urine collection | 0-20 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
augmented renal clearance
The Effect of Pneumoperitoneum on Intracranial Pressure in Pediatric Laparoscopic Surgery: Ultrasonographic Measurement of Optic Nerve Sheath Diameter

Study Overview
=================
Brief Summary
-----------------
The pneumoperitoneum during laparoscopic surgery in pediatrics has the potential to cause an increase of intracranial pressure (ICP). Previous studies have proposed that ultrasonographic measurements of the optic nerve sheath diameter (ONSD) correlate with signs of increased ICP. Therefore, this study aims to confirm the increased ICP by ultrasonographic measurement of ONSD during laparoscopic surgery in pediatric patients.

Conditions
-----------------
Intracranial Pressure

Intervention / Treatment
-----------------
* Device: ultrasonographic measurement of optic nerve sheath diameter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. pediatric patients (under 9 yrs) scheduled for undergoing laparoscopic surgery under general anesthesia Exclusion Criteria: 1. Patients with previous history of neurologic disease or neurosurgery, ocular disease or ocular surgery

Ages Eligible for Study
-----------------
Maximum Age: 9 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 |
| --- | --- |
| laparoscopic surgery under general anesthesia<br>pediatric patients undergoing laparoscopic surgery under general anesthesia | Device: ultrasonographic measurement of optic nerve sheath diameter<br>* A thick layer of gel is applied on the upper closed eyelid. The linear 13- to 6-MHz ultrasound probe is then placed in the gel, without exerting pressure on the eye. Two measurements are taken for each optic nerve: one in the transverse plane, with the probe being horizontal, and one in the sagittal plane, with the probe being vertical. The final ONSD is the mean of these measurements.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ultrasonographic measurement of optic nerve sheath diameter | A thick layer of gel is applied on the upper closed eyelid. The linear 13- to 6-MHz ultrasound probe is then placed in the gel, without exerting pressure on the eye. Two measurements are taken for each optic nerve: one in the transverse plane, with the probe being horizontal, and one in the sagittal plane, with the probe being vertical. The final ONSD is the mean of these measurements. | change of ultrasonographic measurement of optic nerve sheath in 10 minutes after anesthesia induction, 10 minutes after pneumoperitoneum, and 10 minutes after CO2 desufflation. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pneumoperitoneum, pediatric laparoscopy, optic nerve sheath diameter, intracranial pressure
Study Of SU011248 In Combination With Paclitaxel/Carboplatin In Patients With Advanced Solid Tumors

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test SU011248 (sunitinib) in combination with paclitaxel/carboplatin. This combination regimen will be tested for safety and antitumor activity.

Official Title
-----------------
Phase I Study Of SU011248 In Combination With Paclitaxel/Carboplatin In Patients With Advanced Solid Malignancies

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Drug: carboplatin + SU011248 (sunitinib) + paclitaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically proven diagnosis of any advanced solid malignancy that is not amenable to treatment with curative intent Candidates for treatment with carboplatin and paclitaxel with maximum of 2 prior chemotherapy regimens ECOG performance status 0 or 1 Exclusion Criteria: Prior chemotherapy, radiation therapy or surgery within 4 weeks prior to study entry except palliative radiotherapy to non-target, metastatic lesions Diagnosis of any second malignancy within the past 3 years

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: carboplatin + SU011248 (sunitinib) + paclitaxel<br>* AUC of 6 mg*min/mL administered as a 30-minute infusion, every 21 days for 4 cycles or until progression/unacceptable toxicity. 25 mg, 37.5 mg, or 50 mg (depending on the dose level assigned) orally taken every day or for 2 weeks and 1 week off without for 4 cycles or until progression/unacceptable toxicity. 175 mg/m2, 200 mg/m2, or 225 mg/m2 (depending on the dose level assigned), administered as a 3-hour infusion every 21 days for 4 cycles or until progression/unacceptable toxicity.<br>* Other names: Paraplatin; SUTENT; Taxol;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of the maximum tolerated dose (MTD) and overall safety of SU011248 when administered in combination with paclitaxel/carboplatin in patients with advanced solid tumors (ongoing) |  | 3 yrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate pharmacokinetic parameters of carboplatin, paclitaxel, SU011248 and its active metabolite, SU012662. Assess antitumor activity of the combination. |  | 3 yrs |
Study of Prevalence and Clinical Phenotype in Patients With Glucocorticoid-Remediable Aldosteronism

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine the prevalence of glucocorticoid-remediable aldosteronism (GRA) in various hypertensive populations and screen at risk members of GRA pedigrees. II. Investigate other factors regulating blood pressure in GRA (environmental, genetically determined factors). III. Investigate renal and hormonal mechanisms regulating potassium homeostasis in GRA. IV. Describe clinical phenotype of GRA patients. V. Prospectively screen GRA-affected patients with MRI angiography for intracranial aneurysm.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients are screened for high blood pressure, suppressed plasma renin activity level, and low potassium levels. Urine is collected for a 24 hour period. Blood specimen is collected for molecular biologic evaluation for the presence of the chimeric gene diagnostic of GRA. Any history of cardiovascular events is recorded.

Conditions
-----------------
Hyperaldosteronism

Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosed glucocorticoid-remediable aldosteronism (GRA) with hypertension Hypokalemia is variably seen Blood pressure variably elevated Elevated level of aldosterone Low level of plasma renin activity

Ages Eligible for Study
-----------------
Minimum Age: 0 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
-----------------
endocrine disorders, genetic diseases and dysmorphic syndromes, hyperaldosteronism, rare disease
Efficacy and Safety of Licefreee Spray Against Nix 1% Permethrin

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of Licefreee Spray in eradicating head lice as compared to Nix, both are available over-the-counter lice treatments.

Detailed Description
-----------------
Head lice is a worldwide problem. Many treatments for lice appear to be losing their effectiveness; therefore products are needed that safely and effectively eradicate lice.

Official Title
-----------------
A Comparative Study to Demonstrate the Efficacy and Safety of Licefreee Spray Against Nix 1% Permethrin in Head Lice Infested Individuals

Conditions
-----------------
Pediculosis Capitis

Intervention / Treatment
-----------------
* Drug: Licefreee Spray
* Drug: 1% permethrin creme rinse


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be 4 years of age or older Must have an active head lice infestation of at least 10 lice and viable nits Agree not used any other pediculicides or medicated products during the study Agree not to use a nit comb during the study Must have a single place of residence Exclusion Criteria: Used any form of head lice treatment, prescription, OTC or home remedy for at least four weeks prior to their visit Used topical medication of any kind on the hair for a period of 48 hours prior to visit Individuals receiving systemic, topical drugs or medications which may interfere with the study results Has a history of allergy or hypersensitivity to ragweed or any ingredient in either test products Individuals with any visible skin/scalp condition at the treatment site which, in the opinion of the investigator, will interfere with the evaluation Females who are pregnant or nursing

Ages Eligible for Study
-----------------
Minimum Age: 4 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Licefreee Spray<br> | Drug: Licefreee Spray<br>* Liquid applied to hair and left on for at least one hour once on day 1 and once on day 8 if live lice are present.<br>|
| Active Comparator: Nix Creme Rinse, 1% Permethrin<br> | Drug: 1% permethrin creme rinse<br>* Creme rinse applied to hair and rinsed off after 10 minutes once on day 1 and once on day 8 if live lice are present.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Proportion Within Each Treatment Group of Subjects Who Have no Live Lice | No live lice 15 days following initial treatment | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Number of participants with adverse events | 15 days |
Study of LED Phototherapy for Musculoligamentous Lesions

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether LED phototherapy using combined red and near infrared light (approved: Ministry of Health of Russian Federation No. 29/06070997/1080-00, EUROCAT Certificate No. CP033321-IV) is effective in the treatment of musculoligamentous lesions in physiotherapy practice

Conditions
-----------------
Fasciitis, Tendinopathy, Sprains and Strains, Muscle Spasm, Epicondylitis

Intervention / Treatment
-----------------
* Device: Red and near infrared LED phototherapy device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of acute or chronic musculoligamentous lesion Must be able to understand instructions and fill in auto administered questionnaires Informed consent Exclusion Criteria: Use of oral corticosteroids or corticosteroid injections Systemic diseases General contraindications for phototherapy

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Red and near infrared LED phototherapy device|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Antiviral Activity of AZD7295 in HCV Carriers

Study Overview
=================
Brief Summary
-----------------
PK, safety study of AZD7295 in HCV carriers

Official Title
-----------------
A Randomised, DB, PC Study to Determine the PK, Safety and Tolerability Profile and Antiviral Activity of Multiple Oral Doses of AZD7295 in Otherwise Healthy Male and Female Hepatitis C Carriers With Compensated Liver Disease

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

Intervention / Treatment
-----------------
* Drug: AZD7295
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HCV carrier Exclusion Criteria: concurrent medications

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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: Placebo<br>* matched placebo<br>|
| Active Comparator: 2<br> | Drug: AZD7295<br>* 700mg per day maximum<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma AZD7295 concentrations and pharmacokinetics |  | 5 days |
Effect of Transportation Method on Preoperative Anxiety in Children

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of wagon for transporting vehicle instead of standard stretcher car for reducing preoperative children's anxiety.

Official Title
-----------------
Effect of Transportation Method on Preoperative Anxiety in Children

Conditions
-----------------
Anxiety, Child Behavior

Intervention / Treatment
-----------------
* Device: Wagon
* Device: Standard stretcher car


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologist physical status I scheduled for elective surgery under general anesthesia Exclusion Criteria: history of anesthesia or surgery developmental delay weighing over than 38kg severe pain administrated psychotomimetic drug

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 7 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard stretcher group<br>Use a standard stretcher car as a transporting method in the operating room | Device: Standard stretcher car<br> <br> * Other names: Stryker, Stryker medical;|
| Active Comparator: Wagon group<br>Use a wagon as a transporting method in the operating room | Device: Wagon<br> <br> * Other names: wagonTM, Step 2 company;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preoperative anxiety score using the Modified Yale Preoperative Anxiety Scale |  | From entry of operating room to induction of anesthesia |
Study of Admission Versus Discharge After Transient Ischemic Attack (TIA)

Study Overview
=================
Brief Summary
-----------------
Evaluate for difference in outcome between hospital admission versus discharge after recent TIA, and evaluate feasibility of a larger study.

Detailed Description
-----------------
20 patients will be randomized within 24 hours of a TIA to be admitted to the hospital or discharged to home, and the investigator will compare outcomes, cost, and evaluate the feasibility of a larger study.

Official Title
-----------------
Pilot Study of Admission Versus Discharge After Transient Ischemic Attack (TIA)

Conditions
-----------------
Transient Ischemic Attack (TIA), Stroke

Intervention / Treatment
-----------------
* Behavioral: Hospital admission


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 and older. Clinical diagnosis of TIA within 24 hours of consent. Exclusion Criteria: Crescendo TIAs, defined as multiple within 24 hours of presentation. Posterior circulation TIAs diagnosed clinically by a member of the Stroke Team. High grade carotid stenosis. Any compelling medical reason they should or should not be admitted or discharged (for example decompensated congestive heart failure, unstable angina, new EKG changes, pneumonia, sepsis). Patients will only be enrolled if the only consideration for admission is the TIA, and they otherwise meet appropriate standard of care criteria for discharge to home. Patients will be excluded if no one can be with them for the next 12 hours to ensure a rapid call to 911 should problems arise, specifically stroke.

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: Admission<br>Admission | Behavioral: Hospital admission<br> <br> |
| No Intervention: Discharge<br>Discharge | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified Rankin Scale at one year. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke and TIA incidence at one year |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transient Ischemic Attack (TIA)., Stroke., Hospital admission.