linjc16/ctgov huggingface dataset:
506U78 In Relapsed Or Refractory Acute Lymphoblastic Leukemia (T-ALL)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether Nelarabine is effective in the treatment of patients with T-ALL/NHL in order to achieve a complete remission followed by an early stem cell transplantation.

Official Title
-----------------
Phase II-Study With Nelarabine in Patients With Refractory Oder Relapsed T- ALL or T-lymphoblastic Lymphoma (Amend.7)

Conditions
-----------------
T-ALL, T-NHL (Lymphoblastic)

Intervention / Treatment
-----------------
* Drug: Nelarabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: T-ALL; T-NHL age >= 18 years cytological treatment failure / relapse molecular treatment failure / relapse no promising therapy alternatives with approved medication available no CNS-manifestation, requiring intrathecal therapy or CNS-radiation no convulsive disease or neurotoxicity > grade III in patients history written informed consent no cytostatic therapy in the last 10 days no pregnancy or breastfeeding effective contraception recovery of toxicities of previous chemotherapy - except leukemia- related changes like bone marrow suppression or pathological transaminases in liver manifestation Exclusion Criteria: Severe psychiatric illness uncontrolled or severe cardiac disease or infection active secondary neoplasms - except skin cancer (no melanoma)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>Nelarabine | Drug: Nelarabine<br>* 1500 mg/m² i.v., duration 2 hrs, day 1, 3, 5<br>* Other names: Arranon;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability and Efficacy of Compound GW506U78 in relapsed/refractory T-ALL/NHL |  | after 1 cycle and 2 cycles |
Fed Study of Topiramate Sprinkle Capsules 25 mg and Topamax® Sprinkle Capsules 25 mg

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to investigate the bioequivalence of Mylan's topiramate sprinkle 25 mg capsules to Ortho-McNeil's Topamax® Sprinkle 25 mg capsules following a single, oral 25 mg (1 x 25 mg) dose administered under fed conditions.

Official Title
-----------------
Single-Dose Fed Bioequivalence Study of Topiramate Sprinkle Capsules (25 mg; Mylan) and Topamax® Sprinkle Capsules (25 mg; Ortho-McNeil Neurologics) in Healthy Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Topiramate Sprinkle Capsules 25 mg
* Drug: Topamax® Sprinkle Capsules 25 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy, adult subjects, 18 years and older able to swallow medication Exclusion Criteria: institutionalized subjects history of any significant disease use of any prescription or OTC medications within 14 days of start of study received any investigational products within 30 days prior to start of study

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?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Topiramate Sprinkle Capsules 25 mg | Drug: Topiramate Sprinkle Capsules 25 mg<br>* 25mg, single dose fed<br>|
| Active Comparator: 2<br>Topamax® Sprinkle Capsules 25 mg | Drug: Topamax® Sprinkle Capsules 25 mg<br>* 25mg, single dose fed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data. |  | blood collections through 144 hours |
Comparison of Ultrasonic Pachymetry With Orbscan in Corneal Haze

Study Overview
=================
Brief Summary
-----------------
This study is planned to compare the results of ultrasonic and Orbscan pachymetry in corneal haze not related to surgery. Corneal haze is graded with slit-lamp by a single examiner. Ultrasonic and Orbscan II pachymetry measurements are obtained. Paired t and Kruskal-Wallis tests are used to evaluate the difference between ultrasonic and Orbscan pachymetry measurements. Correlation of the two methods and haze grade is determined with Kendall's tau-b correlation analysis.

Detailed Description
-----------------
We planned this study to compare the results of ultrasonic and Orbscan pachymetry in corneal haze not related to surgery. In this institutional based, prospective, controlled clinical trial subjects with corneal haze not related to surgery are included. Normal eyes are used as control group to calculate the customized acoustic factor. Corneal haze is graded with slit-lamp by a single examiner. Ultrasonic and Orbscan II pachymetry measurements are obtained by one technician each masked to the other measurement. Paired t and Kruskal-Wallis tests are used to evaluate the difference between ultrasonic and Orbscan pachymetry measurements. Correlation of the two methods and haze grade is determined with Kendall's tau-b correlation analysis. According to the results of the study, we will determine which method is accurate in subjects with corneal haze.

Official Title
-----------------
Comparison of Ultrasonic Pachymetry With Orbscan in Corneal Haze

Conditions
-----------------
Corneal Opacity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with significant corneal haze on slit-lamp are included in the study group. 50 eyes of 50 age-matched patients with normal eye and clear cornea are included in the control group. Only one eye of each subject is included. Exclusion Criteria: Exclusion criteria to participate in the study are previous ocular surgery, history of contact lens use, glaucoma, and topical ocular medication use, excluding artificial tears.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 71 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
-----------------
Corneal topography, corneal opacity, keratitis, trachoma
Measurements of Exhaled Nitric Oxide in Healthy Subjects in Thailand

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine fractional exhaled nitric oxide (FeNO) level in healthy subjects among Thai populations.

Detailed Description
-----------------
Fractional exhaled nitric oxide (FeNO) were produced from epithelial cells of inflammatory airways and eosinophils and this gas was discovered since 1991. Fractional exhaled nitric oxide (FeNO) has direct association with severity of inflammation of bronchial trees and sputum eosinophils and use for additional investigation for diagnosis asthma or inflammatory airway diseases. There are many factors from previous studies that associate with level of fractional exhaled nitric oxide (FeNO), one of that factors is race therefore we can't use level from another studies with different race for use as reference and there is no study about level of fractional exhaled nitric oxide in Thai population. It is therefore desirable to examine level of fractional exhaled nitric oxide (FeNO) in healthy subjects among Thai population and will be the main objective of this research.

Official Title
-----------------
Measurements of Exhaled Nitric Oxide in Healthy Subjects in Thailand

Conditions
-----------------
Normal Non-fluency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy subjects in community Exclusion Criteria: smoker or past history of smoking asthma, allergic rhinitis, chronic respiratory disease or other chronic illness history of wheezing within 12 months before enrollment history of upper or lower respiratory tract infection within 6 weeks before enrollment drink ethanol within 48 hours before enrollment drink caffeine within day before enrollment during pregnancy chronic use of any drugs participate other project within 30 days

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 60 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 |
| --- | --- | --- |
| fractional exhaled nitric oxide level |  | 10 minutes (average time ), on the day of enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy people, fractional exhaled nitric oxide (FeNo), factors
Drug Provocation Test (DPT) to Paracetamol

Study Overview
=================
Brief Summary
-----------------
Background : Paracetamol (acetaminophen) drug hypersensitivity reactions (DHR) are oonfirmed in about 10% of alleged cases. The diagnosis is made via an empirical drug provocation test (DPT). Objective: Detect eliciting dose thresholds during Paracetamol DPT in order to suggest optimal step doses and to identify variables and potential risk factors associated with Paracetamol hypersensitivity. Methods:This retrospective study, using the survival analysis and the multivariate analysis, will comprise all patients who attended the allergy service of the University Hospital of Montpellier from 1996 till 2018 with a clinical history related to Paracetamol DHR, who underwent Paracetamol DPT and who gave their consent to be included in the study. The patients are selected from the Drug Allergy & Hypersensitivity Database (DAHD).

Official Title
-----------------
Construction and Validation of a Simplified Provocation Test for the Diagnosis of Paracetamol Hypersensitivity

Conditions
-----------------
Drug Hypersensitivity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - Patients with a positive or negative DPT to paracetamol Exclusion criteria: Patients refusing to take part in the study Patient under 10 years old
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 |
| --- | --- | --- |
| Detect of the reactive dose (RD) | The outcome measure of the RD : The dose that the patient reaches when the DPT is positive, divided by the total DPT dose for a given patient. This RD will be calculated for every patient with a positive DPT. New events (positive DPT) from one RD to another will be evaluated in number and severity. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure is a positive DPT to paracetamol | Identifying clinical risk factors (Odds Ratio), using the binary logistic regression method, significantly associated with a positive Paracetamol DPT. Age at reaction, sex, presence of asthma and atopy, type and chronology of the initial reaction will be evaluated as potential risk factors. Risk factors of anaphylaxis during DPT will also be calculated, using the same variables. Potential variables to explain this measure will be introduced in a logistic model, in order to obtain crude and adjusted OR that could explain a positive DPT to paracetamol. | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drug Hypersensitivity Reaction, Drug Provocation Test, Paracetamol, Reactive Doses, Reactive Times, Acetaminophen
Syndecan 1 as Biomarker for Inflammation

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the soluble biomarker syndecan-1 (sSdc1) taken from venous blood of patients with infectious intestinal diseases such as Clostridium difficile-associated colitis, bacterial colitis, Norovirus enteritis and Crohn´s disease or ulcerative colitis. The level of sSdc1 will be compared with disease activity in patients with active inflammation and with disease in remission. Secondary objectives were the assessment of correlation of the above-mentioned factors with the CRP value. Subjects will be volunteers. Blood will be taken as part of the routine clinical work-up after the written agreement blood and sSdc1-level will be assessed using a human-specific sSdc1 ELISA assay. In addition, the subjects are asked to answer a short questionnaire. The study is designed as a prospective, comparative cohort study.

Official Title
-----------------
Soluble Syndecan 1 as Biomarker for Acute and Chronic Bowel Inflammation

Conditions
-----------------
Colitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject with at least 18 years of age able to give informed consent healthy volunteer or inflammatory bowel condition (inflammatory bowel disease, infectious colitis) Exclusion Criteria: not able to give informed consent

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Soluble serum Syndecan-1 in ng/ml |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Underlying disease |  | 6 months | 
| Patient age |  | 6 Months | 
| Disease activity in Inflammatory bowel disease |  | 6 Months | 
| Calprotectin in stool |  | 6 Months | 
| Leucocyte blood count |  | 6 Months | 
| CRP in serum |  | 6 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Syndecan-1, ulcerative colitis, Clostidium difficile-associated colitis, biomarker
Clinical Performance of the Diassess Influenza A and B Test

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is device feasibility of the Diassess Influenza A and B Test

Official Title
-----------------
Clinical Performance of the Diassess Influenza A and B Test

Conditions
-----------------
Influenza, Human, Influenza, Flu

Intervention / Treatment
-----------------
* Device: Diassess Influenza A and B Test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject currently has a fever (≥37.8°C/100°F), or self-reports having had or is currently treating a fever ≥37.8°C/100°F with onset within the previous 72 hrs Subject has at least one additional flu-like symptom including fever or feeling feverish/chills, runny or stuffy nose, muscle or body aches, fatigue (very tired), sore throat, headaches, or cough Exclusion Criteria: Subject received nasal vaccine (e.g. FluMist) within the past 10 days Subject has been taking or took any antivirals for influenza in the past 30 days Subject enrolled in any drug trials
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diassess Influenza A and B Test<br> | Device: Diassess Influenza A and B Test<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diassess test measurement agreement with Polymerase Chain Reaction (PCR) |  | One (1) patient visit which is a time frame of one (1) hour |
Aluminium Foil as an Adjuvant to Phototherapy for Pathological Unconjugated Hyperbilirubinaemia in Full Term Infants

Study Overview
=================
Brief Summary
-----------------
prospective single center pilot randomized open label clinical trial, conducted at the Neonatal care unit of Mansoura University Children's To assess the efficacy and safety of aluminum foil use in combination with phototherapy compared with phototherapy alone for pathological unconjugated hyperbilirubinaemia in full term newborn We enrolled 234 infants in the study who fulfilled the inclusion criteria and were randomly assigned to treatment groups, either conventional phototherapy with aluminum foil or conventional phototherapy alone.

Official Title
-----------------
Aluminium Foil as an Adjuvant to Phototherapy for Pathological Unconjugated Hyperbilirubinaemia in Full Term Infants: Randomised Control Trial

Conditions
-----------------
Neonatal Jaundice

Intervention / Treatment
-----------------
* Device: Phototherapy with aluminum foil
* Device: Phototherapy without aluminum foil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Appropriate for gestational age full-term infants with pathological unconjugated hyperbilirubinaemia who are candidate for photo therapy according to American academy guidelines Exclusion Criteria: Preterm infants, newborn infant with congenital malformations, conjugated hyperbilirubinamia, small for gestational age, in need of exchange transfusion, and skin abrasions or infections

Ages Eligible for Study
-----------------
Maximum Age: 28 Days

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GROUP1<br>Phototherapy with aluminum foil | Device: Phototherapy with aluminum foil<br> <br> |
| Placebo Comparator: GROUP2<br>Phototherapy without aluminum foil | Device: Phototherapy without aluminum foil<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total serum bilirubin | measurement of Total serum bilirubin (mg/dl) | 8 hours of treatment | 
| Total serum bilirubin | measurement of Total serum bilirubin (mg/dl) | 24 hours of treatment | 
| Total serum bilirubin | measurement of Total serum bilirubin (mg/dl) | 48 hours of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of photo therapy | duration of photo therapy in hours | average 48 hours |
Compare of Effectiveness Cycled Light or Near Darkness on Growth Parameters in Preterm Infants

Study Overview
=================
Brief Summary
-----------------
Infants are exposed to either continuous bright light continuous near darkness or unstructured combination of the two. The investigators primary objective is to determine the effectiveness cycled light and near darkness on growth in preterm infants.

Conditions
-----------------
Compare of Effectiveness Cycled Light and Near Darkness on Growth in Preterm Infants

Intervention / Treatment
-----------------
* Other: Cycled light
* Other: Continue near darkness


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: <32 gestational weeks preterm infants Exclusion Criteria: Major congenital anomaly Small for gestation age Grade III-IV intracranial hemorrhage

Ages Eligible for Study
-----------------
Maximum Age: 24 Hours

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 |
| --- | --- |
| Cycled light<br>Approximately 12 hours of light on and 12 hours of light off. | Other: Cycled light<br>* We covered the incubator with blanket for darkness approximately 12 hours.<br>|
| Near darkness<br>Continue near darkness | Other: Continue near darkness<br>* We covered the incubator with blanket all days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness on growth | We recorded infants' weight, height and head circumference measures on day 14, corrected 3 and 6 months. | 3-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feeding | We evaluated full enteral feeding time between two groups. | 0-1 month | 
| Ventilation support | We evaluated duration of supplemental oxygen, nasal continuous positive airway pressure (CPAP) and mechanical ventilation for each groups. | 0-1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cycled light, near darkness, growth