linjc16/ctgov huggingface dataset:
Lactoferrin Versus Ferrous Sulphate for the Treatment of Iron Deficiency Anemia During Pregnancy

Study Overview
=================
Brief Summary
-----------------
The study aims to compare the efficacy and the safety of Lactoferrin versus ferrous sulphate for the treatment of iron deficiency anemia during pregnancy.

Detailed Description
-----------------
The study was done at ainshams university maternity hospital on 100 pregnant women randomized in two groups . Group one lactoferrin group Group two ferrous sulphate group

Official Title
-----------------
Lactoferrin Versus Ferrous Sulphate for the Treatment of Iron Deficiency Anemia During Pregnancy,a Randomized Clinical Trial

Conditions
-----------------
Iron Deficiency Anemia of Pregnancy

Intervention / Treatment
-----------------
* Diagnostic Test: Complete blood count


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women from 20 to 40 years iron deficiency anemia (mild and moderate) gestational age 13 to 26 weeks singleton viable pregnancy. Exclusion Criteria: history of anemia due to chronic blood loss hemolytic anemia severe anemia history of peptic ulcer

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactoferrin<br>To measure hemoglobin difference and serum ferritin | Diagnostic Test: Complete blood count<br>* To measure hemoglobin difference and serum ferritin levels .<br>* Other names: Serum ferritin;|
| Experimental: Ferrous sulphate<br>To measure hemoglobin difference and serum ferritin | Diagnostic Test: Complete blood count<br>* To measure hemoglobin difference and serum ferritin levels .<br>* Other names: Serum ferritin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemoglobin level | Measure hemoglobin level two months after treatment | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum ferritin | Measure serum ferritin level | 2 months |
Study of Blood Platelets in Sickle Cell Disease

Study Overview
=================
Brief Summary
-----------------
We are studying if sickle cell disease blood platelets are larger than normal and how they may cause obstruction of blood vessels. We are also trying to study the reasons why large platelets are found in patients with sickle cell disease.

Detailed Description
-----------------
Research volunteers are seen in the Outpatient Research Center by the Principal Investigator or another physician. A detailed history is obtained, a physical examination is performed, and blood (usually 4 tablespoons) is obtained for additional tests. The research volunteer's previous medical records will be requested. Upto 5 additional blood samples may be obtained in a subgroup of patients.

Official Title
-----------------
Studies of Large Platelets in Patients With Sickle Cell Disease

Conditions
-----------------
Sickle Cell Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults and children > 7 years of age with sickle cell disease (Hb SS) who are not taking hydroxyurea and are not receiving routine blood transfusion therapy. Exclusion Criteria: Current hydroxyurea therapy or, Hydroxyurea use within the past 3 months Blood transfusion or exchange transfusion within the past 3 months Current treatment with aspirin or clopidogrel

Ages Eligible for Study
-----------------
Minimum Age: 7 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 |
| --- | --- | --- |
Comparative Quantification of MTX and Its Metabolites Post Glucarpidase

Study Overview
=================
Brief Summary
-----------------
Acidification (i.e., addition of hydrochloric acid) of plasma samples from patients who have received Glucarpidase post high-dose MTX treatment is regarded as a necessary preanalytic step to avoid further in vitro enzymatic cleavage of MTX. However, it is unclear whether this acidification step is essential. A comparative study, which evaluates concentrations of MTX and its metabolites in paired (acidified versus non-acidified) plasma samples, has not yet been performed. Processing plasma samples without acidification would facilitate quantification of MTX, including plasma samples from patients treated at centers without adequate laboratory facilities.

Detailed Description
-----------------
Stored plasma samples (paired - acidified and non-acidified) from the specimens collection ('Tumorbiobank') of the Charité Comprehensive Cancer Center will be analysed by HPLC/MS. A total of 136 samples from patients post Voraxaze across 3 levels of MTX concentrations: 30 without additive, 10 with 0.9% NaCl, 30 with HCl (stored at -80C) 9 without additive, 9 with HCl (stored at +4C and analysed after 3-5 days) 9 without additive, 9 with HCl (stored at -20C and analysed after 3-5 days) 30 with HCl (stored at +4C versus ambient temperature)

Official Title
-----------------
Comparative Quantification of MTX and Its Metabolites in Acidified vs. Non-acidified Blood Samples Post Glucarpidase Using HPLC/MS

Conditions
-----------------
Lymphoma, Acute Lymphatic Leukemia

Intervention / Treatment
-----------------
* Diagnostic Test: HPLC/MS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Treatment with Glucarpidase Exclusion Criteria: Lacking patient consent
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: HPLC/MS|Quantification of MTX and its metabolites by HPLC/MS under various preanalytical conditions|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consistency of MTX concentrations in paired acidified vs. non-acidified samples | Comparison of MTX/metabolite concentrations | within 3 days of Glucarpidase treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consistency of MTX concentrations in paired samples stored at -80C vs. +4C vs. ambient temperature | Comparison of MTX/metabolite concentrations | within 3 days of Glucarpidase treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Preanalytical Conditions
To Demonstrate the Relative Bioequivalence of Lisinopril 1 x 40 mg Tablets Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
To Demonstrate the Relative Bioequivalence of Lisinopril 1 x 40 mg Tablets Under Fasting Conditions.

Official Title
-----------------
Randomized, 2-Way Crossover, Bioequivalence Study of Eon Labs Manufacturing Inc. (USA) and Zeneca (USA) (Zestril) 40 mg Lisinopril Tablet Administered as a 1 x 40 mg Tablet in Health Adult Males Under Fasting Conditions.

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Lisinopril 40 mg Tablet (EON Labs Manufacturing Inc, USA)
* Drug: Lisinopril 40 mg Tablet (Zestril) (Zeneca, USA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: Positive test results for HIV or hepatitis B or C. Treatment for drug or alcohol dependence.

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

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Lisinopril 40 mg Tablet (EON Labs Manufacturing Inc, USA) | Drug: Lisinopril 40 mg Tablet (EON Labs Manufacturing Inc, USA)<br> <br> |
| Active Comparator: 2<br>Lisinopril 40 mg Tablet (Zestril) (Zeneca, USA) | Drug: Lisinopril 40 mg Tablet (Zestril) (Zeneca, USA)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  | 23 days |
Targeting Leukemic Stem Cell Expressing the IL-1RAP Protein in Chronic Myelogenous Leukemia (CML)

Study Overview
=================
Brief Summary
-----------------
The tyrosine kinase inhibitor therapy (iTKs) is the first-line treatment of chronic myelogenous leukemia (CML). Its effectiveness in controlling the progression of the disease is such that it is possible today to consider stopping treatment in patients with deep molecular response (> RM4.0). Only in about 50% of cases, patients relapse. It has been shown in these patients that hematopoietic stem cells (HSCs) are persistant, quiescent and insensitive to iTKs. These cells are probably at the origin of relapse. It is therefore necessary to develop complementary therapies to cure the disease and consider discontinuation iTKs The development of anti-tumor immunotherapy approach using genetically modified T cells to express a chimeric antigen receptor (CAR) and specifically targeting CML CSH + could address this issue. The membrane expression of the IL-1-RAP protein could be an interesting target.

Official Title
-----------------
Targeting Leukemic Stem Cell Expressing the IL-1RAP Protein in Chronic Myelogenous Leukemia (CML)

Conditions
-----------------
Chronic Myeloid Leukemia

Intervention / Treatment
-----------------
* Other: biological samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients for whom there is a strong suspicion of CML diagnosed as part of routine activity. written informed consent Exclusion Criteria: patient with atypical CML patient with a non SMP CML patients previously treated with interferon patient enrolled in another study therapy or within the exclusion period thereof pregnant or breast-feeding women patient under guardianship, curator or under the protection of justice.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Additional biological samples<br>Bone marrow sample and blood collected at J0 (screening visit), and at 3, 6, 12, 18 and 24 months and at each additional consultations (relapse ...) | Other: biological samples<br>* bone marrow and blood<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IL1RAP protein expression on the surface of cells detected by flow cytometry |  | up to 2 years after inclusion |
An Intervention Study to Assess the Role of the Built Environment on Physical Activity and Active Transportation to School in Children and Youth

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate if changes to the built environment influence physical activity and active transport to school in children and youth.

Official Title
-----------------
Active Streets, Active People - Junior: An Integrated Community Partnership to Enhance Physical Activity and Active Transport to School in Children and Youth

Conditions
-----------------
Physical Activity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Student is in grade 4 - 10 at start of study (fall 2012), or grade 4 at any of the subsequent study years (2013-2015). Student's parent(s) or guardian(s) provide(s) consent. Exclusion Criteria: Student is not in grade 4 - 10 at start of study (fall 2012). Student's parent(s) or guardian(s) do(es) not provide consent. Student cannot read or write in English.

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 17 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 |
| --- | --- |
| Intervention<br>Intervention group is geographically located near a built environment intervention (neighbourhood redevelopment). | |
| Comparison<br>Comparison group is not exposed to the built environment intervention according to their geographic location. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objectively measured physical activity overall (minutes of moderate-to-vigorous physical activity per day) | Accelerometry (ActiGraph, FL, USA) | up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objectively measured physical activity during commuting to and from school (minutes of moderate-to-vigorous physical activity during commuting) | Accelerometry (ActiGraph, FL, USA) | up to 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physical Activity, Physical Fitness, Transportation, Environment Design, Child, Adolescent
Lichtenstein Patch or Prolene Hernia System (PHS) for Inguinal Hernia Repair

Study Overview
=================
Brief Summary
-----------------
This randomised prospective study was designed to compare the convalescence and the long-term sequelae in inguinal hernia repair with either a bilayer mesh as devised by Gilbert (Prolene Hernia System®) or an onlay mesh applied according to Lichtenstein.

Official Title
-----------------
Randomized Clinical Trial of Lichtenstein Patch or Prolene Hernia System for Inguinal Hernia Repair

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Procedure: Open mesh inguinal hernia repair
* Device: Prolene Hernia System
* Procedure: Lichtenstein technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Uni- or bilateral Primary or recurrent Exclusion Criteria: body-mass index over 40kg/m2, severe co-morbidities

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prolene Hernia System device<br>Inguinal hernia repair either with a bilayer mesh (PHS) | Procedure: Open mesh inguinal hernia repair<br>* Inguinal hernia repair either with the bilayer mesh or the Lichtenstein technique<br>Device: Prolene Hernia System<br>* Prolene Hernia System<br>|
| Experimental: Lichtenstein<br>Inguinal hernia repair with the Lichtenstein technique | Procedure: Open mesh inguinal hernia repair<br>* Inguinal hernia repair either with the bilayer mesh or the Lichtenstein technique<br>Procedure: Lichtenstein technique<br>* Lichtenstein technique<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term Sequelae | Any pain at five years | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inguinal hernia, Open mesh repair, Long term outcome, Recurrence, Discomfort
The Use of EndoFlip as a Clinical Tool for the Prediction of Postoperative GERD After Sleeve Gastrectomy

Study Overview
=================
Brief Summary
-----------------
This study aims to determine if preoperative EndoFlip measurement can effectively predict postoperative GERD-related quality of life and lower esophageal acid exposure.

Detailed Description
-----------------
Enrolled patients will be subjected to a pre-operative gastroscopy, 48-Hour Bravo pH study and EndoFlip. In addition, each patient will complete a GERD-related quality of life questionnaire (GERD-HRQL scale). One year after surgery, patients will undergo a follow up a gastroscopy, pH study, EndoFlip and the same quality of life questionnaire to predict the incidence of postoperative GERD and determine the effect of sleeve gastrectomy.

Official Title
-----------------
The Use of EndoFlip as a Clinical Tool for the Prediction of Postoperative GERD After Sleeve Gastrectomy

Conditions
-----------------
Gastroesophageal Reflux, Sleeve Gastrectomy, Bariatric Surgery Complication

Intervention / Treatment
-----------------
* Procedure: sleeve gastrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18 and 65 years old Exclusion Criteria: Hiatal hernia > 2 cm at preoperative gastroscopy Erosive esophagitis at preoperative gastroscopy Barrett's metaplasia/dysplasia at preoperative gastroscopy Revision surgery before the end of the study Pregnancy during the study period Actively bleeding esophageal varices

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: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Before/after study design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Before sleeve gastrectomy<br>Gastroesophageal Reflux Disease (GERD) will be evaluated before surgery. EndoFlip, gastroscopy, pH-study and GERD-Health-Related Quality of Life Questionnaire will be realized for all patients. | |
| Experimental: Sleeve gastrectomy<br>After the surgical intervention, new onset or worsening of GERD will be evaluated. | Procedure: sleeve gastrectomy<br>* Patients will be recruited for a sleeve gastrectomy according to the guidelines of the National Institute of Health.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New-onset of gastroesophageal reflux disease | total time of esophageal acid exposure (minutes) | 12 months postoperatively |
Rapid Renal Sympathetic Denervation for Resistant Hypertension II

Study Overview
=================
Brief Summary
-----------------
This is a global, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation with the OneShot Renal Denervation System in patients with uncontrolled hypertension.

Official Title
-----------------
Rapid Renal Sympathetic Denervation for Resistant Hypertension Using the OneShot Renal Denervation System II

Conditions
-----------------
Resistant Hypertension, Uncontrolled Hypertension, Renal Artery Ablation

Intervention / Treatment
-----------------
* Device: Renal Denervation (OneShot™ Renal Denervation System)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individual has a systolic blood pressure ≥ 160 mmHg based on an average of three office blood pressure readings. Stable drug regimen including three or more anti-hypertensive medications including a diuretic Exclusion Criteria: Renal anatomy unsuitable for treatment Presence of hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous Patient has Type I diabetes Has scheduled or planned surgery within the next 6 months Individual is pregnant nursing or plans to be pregnant

Ages Eligible for Study
-----------------
Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal Denervation<br>Subjects randomized to the Renal Denervation arm will receive bilateral renal ablation with the OneShot system and be maintained on antihypertensive medication. | Device: Renal Denervation (OneShot™ Renal Denervation System)<br> <br> * Other names: Catheter-based renal denervation;|
| No Intervention: Optimal Medical Therapy<br>Subjects randomized to the control arm will be maintained on antihypertensive medications. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse event (MAE) rate through 30 days post randomization |  | 30 days | 
| Change in office systolic blood pressure (SBP) from baseline to 6 months post-randomization |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Procedural Safety |  | 30 days | 
| Chronic procedural safety |  | 6 months | 
| Reduction in SBP by >10 mmHg at 6 months |  | 6 months | 
| Changes in office SBP and diastolic blood pressure (DBP) from baseline to follow-up visits |  | 6, 12, 24, and 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Resistant hypertension, Uncontrolled hypertension, Renal artery ablation