linjc16/ctgov huggingface dataset:
A Study to Evaluate Raptiva in Adults With Plaque Psoriasis Previously Enrolled in Study ACD2390g

Study Overview
=================
Brief Summary
-----------------
This is an open-label, multicenter study designed to evaluate the efficacy and safety of efalizumab administered at weekly SC (subcutaneous) doses of 1.0 mg/kg followed by efalizumab taper in subjects with plaque psoriasis who previously participated in Study ACD2390g.

Official Title
-----------------
An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of 1.0 mg/kg Subcutaneously Administered Efalizumab Followed by Efalizumab Taper in Adults With Plaque Psoriasis Previously Enrolled in Study ACD2390g

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: Raptiva (efalizumab)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent Previous participation in Study ACD2390g For women of childbearing potential, continued use of an acceptable method of contraception for the duration of their participation in the study Willingness to continue to hold sun exposure reasonably constant and to avoid use of tanning booths or other UV light sources throughout the study Exclusion Criteria: Any medical condition that, in the judgment of the investigator, would jeopardize the subject's safety following exposure to efalizumab Systemic therapy for psoriasis (ET Day 0 through FU Day 84 or upon relapse or unusual presentation of psoriasis in the FU period, whichever occurs first) Systemic immunosuppressive drugs for other indications (ET Day 0 through FU Day 84) Topical therapies for psoriasis (ET Day 0 through ET Day 84) Live virus or bacteria vaccines (ET Day 0 through FU Day 84) Other vaccines or allergy desensitization (it is recommended that these be scheduled after FU Day 84) Other experimental drugs or treatments (ET Day 0 through FU Day 84) Beta-Blockers, ACE inhibitors, interferons, quinidine, antimalarial drugs, or lithium (if clinically indicated, such medications are allowed but the dosage should be held constant between ET Day 0 and TT Day 84)
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Raptiva (efalizumab)|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
-----------------
Plaque Psoriasis, Topical
Effect of Different Biomimetic Materials on White Spot Lesions in Enamel

Study Overview
=================
Brief Summary
-----------------
This study will be conducted to evaluate: 1- The remineralizing effect of different biomimetic materials (Zinc carbonate hydroxyapatite nanoparticles, Poly-amido amine (PAMAM) and bioactive glass nanoparticles) on white spot lesions in enamel. 2- The clinical efficacy of these agents on disappearance of these white spots.

Official Title
-----------------
Effect of Different Biomimetic Materials on White Spot Lesions in Enamel

Conditions
-----------------
White Spot Lesion

Intervention / Treatment
-----------------
* Other: Time of assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Total of 21 patients enrolled in this study will be selected having at least 4 teeth (one on each quadrant) which will be extracted for orthodontic treatment. These patients will be selected according to age groups between 15-25 years old good oral hygiene free of destroying habits for dental tissues Exclusion Criteria: Bruxism soft drinks consumption acid regurgitation, etc.). Selected teeth having any cracks, malformations, dysplasia or caries.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 25 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: Crossover Assignment
Interventional Model Description: Split mouth technique
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zinc carbonated hydroxy apatite<br>Toothpaste to be added on white spot lesions in dental enamel | Other: Time of assessment<br>* Immediate and after one month and after two months<br>|
| Experimental: Bioactive glass<br>Toothpaste to be added on white spot lesions in dental enamel | Other: Time of assessment<br>* Immediate and after one month and after two months<br>|
| Experimental: Poly amido amine<br>Resinous material to be painted on white spot lesions in dental enamel | Other: Time of assessment<br>* Immediate and after one month and after two months<br>|
| No Intervention: Control<br>No material to be added | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in remineralization from base line to time limit | Change in its density in digital xray | Immediate and one month and two months | 
| changes of appearance from base line photograph to time limit | White spots disappear on digital photography | Immediate and one month and two months |
Effects of Preoperative Anxiety and Pain Sensitivity in Cases of Endoscopic Ultrasonography Received Sedoanalgesia

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to detect whether preoperative anxiety and pain sensitivity had effects on the consumption of anesthetics, time to achieve desired level of sedation, patient and endoscopist satisfaction, and postoperative recovery time and pain in deep sedation.

Official Title
-----------------
The Effects of Preoperative Anxiety and Pain Sensitivity on the Intraoperative Hemodynamics, Consumption of Propofol and Postoperative Recovery in Cases of Endoscopic Ultrasonography (EUS) Received Sedoanalgesia

Conditions
-----------------
Sedoanalgesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA 1-2 category between the ages of 20 and 65 patients who has an education level and mental state to complete the scale and questionnaire provided for assessment Exclusion Criteria: patients who has a psychiatric and neurological disease and use psychiatric drugs and chronic alcohol intake

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| consumption of propofol(mg) | initial dose infusion of 1 mg.kg-1 , maintenance dose 2 mg/kg/h, additional dose 0,1mg/kg in case of insufficient sedation | 1-3 hours | 
| the heart rate(n/min) | During procedure | 1-3 hours | 
| arterial pressure(mmHg) | During procedure | 1-3 hours | 
| peripheral oxygen saturation(%) | during procedure | 1-3 hours | 
| postoperative nausea and vomiting (Numeric Rank Score) | After procedure | 1-3 hours | 
| Post-procedure pain(Visual Analog Score) | After procedure | 1-3 hours |
Mitra v Fingerprick Tacrolimus Creatinine

Study Overview
=================
Brief Summary
-----------------
Patients with kidney transplant have blood tests very often. This is normally done in hospital and using a needle inserted into the vein. Two tests are important for kidney transplant patients - creatinine to monitor the health of the kidney; and tacrolimus to measure the level of the medicine which prevents rejection. The investigators would like to compare a fingerprick microsampling method to the standard venous blood. The fingerprick test is the same done by patients with diabetes and we use a microsampling tip which looks like a cotton bud to draw up a small amount of blood. Each tip draws up exactly 10 microlitres which is two drops. The investigators want to compare the results of creatinine and tacrolimus done through the two methods. In the future, this would allow patients to do their creatinine and tacrolimus test at home. The tips dry completely and can be posted to a laboratory. We hope this will make life easier for transplant patients and also help them engage more with the care of their condition.

Official Title
-----------------
Comparison of Standard Venous Sampling for Measurement of Tacrolimus and Creatinine Versus Fingerprick Mitra® Volumetric Absorptive Microsampling in Adult Renal Transplant Recipients

Conditions
-----------------
Transplant;Failure,Kidney

Intervention / Treatment
-----------------
* Diagnostic Test: Mitra


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Kidney transplant recipients. Taking tacrolimus Exclusion Criteria: Unable to consent
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: Blood sample<br>Venepuncture vs fingerprick test using Mitra volumetric absorptive microsampling (VAMs) | Diagnostic Test: Mitra<br>* When the patients have their bloods done through venepuncture, an additional 5-10mls will be taken (one EDTA bottle for tacrolimus and one serum bottle for creatinine; and two Mitra VAMs). Patients will also have a fingerprick test and 20 microlitres of blood taken using Mitra volumetric absorptive microsampling (VAMs)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of creatinine and tacrolimus values for Mitra VAM (test) versus venous sampling (standard). | Compare blood results for creatinine and tacrolimus using two different methods - Mitra volumetric absorptive microsamplers (VAM) versus venous blood (standard). | 3 months |
Olmesartan Medoxomil Versus Losartan in Patients With Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the efficacy and safety of oral administration of olmesartan medoxomil compared to losartan in subjects with mild to moderate hypertension.

Official Title
-----------------
A Multi-center, Double Blind, Efficacy, and Safety Study of the Oral Angiotensin II Receptor Blocker Olmesartan Medoxomil Versus Losartan in Patients With Mild to Moderate Essential Hypertension

Conditions
-----------------
Essential Hypertension

Intervention / Treatment
-----------------
* Drug: olmesartan medoxomil
* Drug: losartan potassium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diastolic BP 95 mm Hg - 114 mm Hg inclusive No participation in any clinical trial for the last 3 months Exclusion Criteria: Secondary hypertension Malignant hypertension Severe arterial hypertension Significant cardiovascular disease History or clinical evidence of cerebrovascular, gastrointestinal, hematological, hepatic disease, myocardial infarction, or severe liver disorder Clinical evidence of renal disease, poorly controlled diabetes, known malabsorption syndromes, psychiatric/emotional problems

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 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: 1<br>olmesartan medoxomil | Drug: olmesartan medoxomil<br>* olmesartan medoxomil oral tablets, once daily for up to 12 weeks<br>|
| Active Comparator: 2<br>losartan potassium | Drug: losartan potassium<br>* losartan oral tablets, once daily for up to 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change of Sitting dBP From Baseline to Week 12 | The difference in the sitting diastolic blood pressure (dBP) at trough, i.e. 24±2 hours after drug administration, from base line to Week 12. | Baseline to 12 weeks |
Study on Short Chain Fatty Acids Concentration in Breast Milk and Its Correlation With the Maternal Diet

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the acetate, butyrate and propionate concentration in breast milk and to evaluate the possible correlation of these concentrations with maternal diet.

Official Title
-----------------
Short Chain Fatty Acids in Breast Milk

Conditions
-----------------
Short Chain Fatty Acids Concentration in Breast Milk

Intervention / Treatment
-----------------
* Other: sampling of breast milk, obtaining information about the maternal diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: parturients women at term hospitalized in the Department of Obstetrics, Gynecology and Pathophysiology of Human Reproduction, Federico II University of Naples. Exclusion Criteria: infections, diabetes and other chronic diseases at the level of each organ or system, diseases of pregnancy. antibiotics, prebiotics, probiotics and synbiotics in the 30 days prior to the first observation.
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: sampling of breast milk, obtaining information about the maternal diet|take samples of 3 ml breast milk and 3-days diet diaries|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| butyrate, acetate and propionate concentration |  | 10 days after delivery and every 30 days until the fifth month after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between short chain fatty acids in breast milk and maternal diet (amount of fibers in maternal diet and based on this it will evaluate the variations in short chain fatty acids concentration) | Relationship between short chain fatty acids in breast milk and maternal diet will be measured by assessing the amount of fibers in maternal diet and based on this it will evaluate the variations in short chain fatty acids concentration. These assessments will be carried out by using a food diary carefully compiled by mothers before each sampling of breast milk | 10 days after delivery and every 30 days until the fifth month after delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast milk, short chain fatty acids, maternal diet
Study of the Depth of Anesthesia on Postoperative Clinical Outcome in Patients With Supratentorial Tumor

Study Overview
=================
Brief Summary
-----------------
Recent studies have shown that deep anesthesia is associated with poor outcome. There is still lack of randomized controlled trials with large sample size on the effect of depth of anesthesia on the postoperative outcomes in patients undergoing brain tumor resection. The investigators are performing a randomized and parallel group trial. The aim of the study is to determine whether there is a causal relationship between the depth of anesthesia and postoperative clinical outcome in patients undergoing supratentorial tumor surgery.

Official Title
-----------------
Study of the Depth of Anesthesia on Postoperative Clinical Outcome in Patients With Supratentorial Tumor

Conditions
-----------------
Anesthesia, Brain Tumor, Supratentorial,Outcome

Intervention / Treatment
-----------------
* Other: Bispectral index will be targeted at 50
* Other: Bispectral index will be targeted at 35


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled to receive elective supratentorial tumor resection under general anesthesia from 2017 to 2019 will be recruited in the trial. Inclusion criteria include ages between 18 and 80 years old, American Society of Anesthesiologists (ASA) physical status Ⅲ-Ⅳ, surgery duration expected to be equal or more than three hours, postoperative hospital stay expected to be equal or more than five nights, and monitoring BIS throughout anesthesia. Exclusion Criteria: Patients who undergo emergency or awake craniotomy surgery, or unable to present the written consent will be excluded from the trial. The patients whose incision site conflicts with the placement of BIS electrode on the frontal and temporal lobe will also be excluded from the study.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: The deep anesthesia group<br> | Other: Bispectral index will be targeted at 35<br>* The depth of general anesthesia will be monitored by bispectral index (BIS) at 35.<br>|
| Other: The light anesthesia group<br> | Other: Bispectral index will be targeted at 50<br>* The depth of general anesthesia will be monitored by bispectral index (BIS) at 50.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability-free survival rate | World Health Organization Disability Assessment Schedule 2.0 Scale will be used to assess the body disability. Disability is defined as a 4-point increasement in the WHODAS score. | Postoperative 30 days |
Clearance of NNAL and Cotinine From Second-hand Smoke in Hair and Urine

Study Overview
=================
Brief Summary
-----------------
This study will investigate how long it takes for NNAL and cotinine, markers of second hand smoke, to clear the human body.

Detailed Description
-----------------
The purpose of the study is to investigate how long it takes for NNAL and cotinine, both specific markers of second hand tobacco smoke exposure to clear the human body.

Official Title
-----------------
Elimination of NNAL and Cotinine From Hair and Urine

Conditions
-----------------
Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Caucasians and African-Americans 19 years of age or above, how are ready to quit smoking Exclusion Criteria: Anyone who is not a Caucasian or an African-American, below 19 years of age, and is currently taken prescription medication.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 75 Years

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

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

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
-----------------
NNAL, Cotinine, Second hand smoke
Association Between ORA and Residual Refractive Astigmatism After SMILE

Study Overview
=================
Brief Summary
-----------------
The aim of our study is to analysis and compare the relationship between ORA and postoperative astigmatism in low astigmatism (less than 1D) and moderate to high (1D to 3D) astigmatism patients after SMILE (Small Incision Lenticule Extraction) refractive surgery.

Official Title
-----------------
Association Between Preoperative Ocular Residual Astigmatism(ORA) and Residual Refractive Astigmatism After SMILE Refractive Surgery

Conditions
-----------------
Refractive Errors, Astigmatism

Intervention / Treatment
-----------------
* Procedure: Small Incision Lenticule Extraction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Corrected distance visual acuity of both eyes reaches 0.1 logarithm of the minimum angle of resolution (logMAR) Stable refractive errors of myopia and astigmatism who received SMILE refractive surgery of both eyes Exclusion Criteria: Cataract Corneal opacities or irregularities Dry eye (Schirmer's test I ≤ 5mm) Amblyopia Coexisting ocular pathologies Glaucoma Non-dilating pupil History of intraocular surgery, laser therapy, or retinopathy Optic nerve or macular diseases Estimated postoperative cornea residual stromal thickness less than 250 μm Pregnancy or under lactation Uncontrolled diabetic mellitus or systemic immune disease _Refusal or unable to maintain follow-up

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Small Incision Lenticule Extraction|A 500 kHzVisumax (Carl Zeiss Meditec AG) femtosecond laser was used with cap thickness ranging from 100 to 130μm, cap diameter from 7.3 to 7.9 mm. The lenticule was dissected with a blunt spatula through a 30 to 60-degree incision at the 10 o'clock position and removed using forceps afterward. Treatment targets of both eyes were set to emmetropia, the refraction corrections were based on manifest refractions|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corrected distance visual acuity | in LogMAR unit | 3 months after surgery | 
| Manifest refraction | in Diopter | 3 months after surgery |