linjc16/ctgov huggingface dataset:
Serum Hepcidin, Haemoglobin Level and Iron Status in Chronic Kidney Disease Patients (CKD) With Anaemia

Study Overview
=================
Brief Summary
-----------------
The current study is planned to assess possible relationships of serum hepcidin levels with haemoglobin levels, inflammation and iron statuses in stage 4 CKD patients.

Official Title
-----------------
Association Between Hepcidin, Haemoglobin Level and Iron Status in Stage 4 Chronic Kidney Disease Patients With Anaemia

Conditions
-----------------
CKD Stage 4

Intervention / Treatment
-----------------
* Diagnostic Test: serum hepcidin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (>18 years) with anaemia who had CKD stage 4 with glomerular filtration rate (GFR) 15-29 ml/min/1.73 m2 Exclusion Criteria: Subjects with blood transfusion within the preceding 3 months. myocardial infarction (MI) history within the preceding 3 months, surgical history within the preceding 3 months, malignancy. Advanced liver cirrhosis. uncontrolled diabetes

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: serum hepcidin|it is a serum marker|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relation between serum hepcidin level and ESR ckd stage 4 | measure strength of relation, r, between levels of serum hepcidin and ESR, an inflammation marker | at study entry and then again after 3 months | 
| relation between serum hepcidin and serum ferritin levels | measure strength of relation, r, between levels of hecidin and ferritin | at study entry and then again after 3 months |
Phase I, Open-label, Dose Escalation of AZD4877 in Hematologic Malignancies

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD4877 based on the side effects experienced by patients that receive AZD4877 on a weekly basis in these diseases.

Official Title
-----------------
A Phase I, Open-label, Dose Escalation Study to Assess the Safety, Tolerability & Pharmacokinetics of AZD4877 Administered Once Weekly in Adult Patients With Recurrent or Refractory AML, PH Negative ALL, NHL or MN

Conditions
-----------------
Lymphoma

Intervention / Treatment
-----------------
* Drug: AZD4877


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with AML, a certain type of ALL, NHL and MM certain types of cancer of the lymph nodes certain types of leukemias (blood cancers) disease has or will fail with other treatments relatively good overall health other than your cancer Exclusion Criteria: poor bone marrow function (not producing enough blood cells) serious heart conditions poor liver or kidney function

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

| Intervention/Treatment |
| --- |
|Drug: AZD4877|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
-----------------
Phase I, cancer, lymphoma, leukemia, myeloma, AML, ALL, NHL, MM
Cerebral Dynamic Perfusion Study With Spectral CT in Patients Suspected of Stroke

Study Overview
=================
Brief Summary
-----------------
Generate a dynamic mapping of the distribution of iodine within the cerebral parenchyma in the patient suspected of acute ischemic disorder with the CT spectral scanner. Correlate the anomalies of iodine mapping to the other parameters acquired during the classic dynamic infusion phase to define the ischemic area (MTT higher and rCBV normal) versus infarcted zone (MTT higher and rCBV decreased)

Official Title
-----------------
Cerebral Dynamic Perfusion Study With Spectral CT in Patients Suspected of Stroke

Conditions
-----------------
Stroke, Acute

Intervention / Treatment
-----------------
* Radiation: spectral CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical suspicion of hyperacute stroke (6 hours after onset of symptoms) Age between 50 and 95 years Weight: between 65 and 95 kg Exclusion Criteria: Documented or suspected allergy to IV iodinated contrast media Renal impairment with creatinine clearance <60 ml / min Hemorrhagic lesions or vascular abnormalities demonstrated on CT before contrast injection

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 95 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stroke<br>Clinical suspicion of hyperacute stroke (6 hours after onset of symptoms):Intervention 'spectral CT' | Radiation: spectral CT<br>* Head spectral CT<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebral Blood Volume (CBV) | CBV is measured in units of milliliters of blood per 100 g of brain and is defined as the volume of flowing blood for a given volume of brain. | from start of the study procedure (CT scan) through end of study procedure (from 15 minutes to 30 minutes) | 
| Mean Transit Time (MTT) | MTT is measured in seconds and defined as the average amount of time it takes blood to transit through the given volume of brain. | rom start of the study procedure (CT scan) through end of study procedure (from 15 minutes to 30 minutes) | 
| Cerebral Blood Flow (CBF) | CBF is measured in units of milliliters of blood per 100 g of brain tissue per minute and is defined as the volume of flowing blood moving through a given volume of brain in a specific amount of time. | rom start of the study procedure (CT scan) through end of study procedure (from 15 minutes to 30 minutes) |
BIO|STREAM.ICM France

Study Overview
=================
Brief Summary
-----------------
The main objective of the BIO│STREAM.ICM France submodule is to provide clinical evidence from patients in France on safety and efficacy of the BIOMONITOR system

Detailed Description
-----------------
The BIO|STREAM.ICM submodule will recruit a subset of patients with syncope with uncertain origin and cryptogenic stroke without history of atrial arrhythmia from the existing population enrolled in the BIO|STREAM.ICM registry. The submodule study is designed to provide clinical evidence from patients in France on safety and efficacy of the BIOMONITOR System.

Official Title
-----------------
BIO|STREAM.ICM France, Submodule of the BIO|STREAM.ICM Registry

Conditions
-----------------
Syncope, Cryptogenic Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication for ICM device in accordance with the European guidelines: syncope with uncertain origin or cryptogenic stroke without history of atrial arrhythmia Enrolled in the BIO|STREAM.ICM registry Exclusion Criteria: Life-expectancy is less than 3 months Already implanted with BIOMONITOR

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| SADE free rate | Serious adverse device effect (SADE) free rate related to the BIOMONITOR system | 3 month |
AMR of Streptococcus Pneumoniae Carriage Strains

Study Overview
=================
Brief Summary
-----------------
This study looks at the usage of human antibiotics for treatment of animals in Bangladesh.

Official Title
-----------------
Antimicrobial Resistance of Streptococcus Pneumoniae Carriage Strains Among Bangladeshi Neonates: Epidemiology, Determinants and Risk Factors

Conditions
-----------------
Infection

Intervention / Treatment
-----------------
* Procedure: Antibiotic use


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bangladesh location Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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

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

Design Details

Primary Purpose: Educational/Counseling/Training
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Antibiotic use|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
-----------------
animal antibiotics, human antibiotics
Vitamin D Levels in Children Undergoing Adenotonsillectomies and Controls

Study Overview
=================
Brief Summary
-----------------
The investigators aim to evaluate the levels of serum Vitamin D in children having their tonsils removed and appropriate controls. The investigators hypothesize that children undergoing tonsil removal will have lower Vit D levels than accepted norms and when compared to controls. The investigators also hypothesize that Vitamin D deficiency will correlate with indicators of inflammation such as C-Reactive Protein (CRP) and tonsil size.

Official Title
-----------------
Vitamin D Levels in Children Undergoing Adenotonsillectomies and Controls

Conditions
-----------------
Tonsillitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children age 1-12 undergoing adenotonsillectomy (active) or elective surgery such as hernia repair (control) Exclusion Criteria: children on systemic steroids or multivitamins containing vitamin D control subjects with: a history of snoring, recurrent tonsillitis or score equal to or higher than 5 on the OSA questionnaire.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 12 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 |
| --- | --- |
| 1<br>children undergoing adenotonsillectomy | |
| 2<br>children undergoing elective procedures other than adenotonsillectomy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Cinical Trial to Explore the Efficacy of Statin/Choline Fenofibrate Combination Therapy vs Statin Monotherapy in Patients With Inadequately Controlled TG Despite Receiving Statin Monotherapy

Study Overview
=================
Brief Summary
-----------------
A Multi-center, Randomized, Double-blind, Parallel Phase Ⅳ Study to Explore the Efficacy of Statin/Choline Fenofibrate Combination Therapy vs Statin Monotherapy in Patients With Inadequately Controlled TG Despite Receiving Statin Monotherapy

Official Title
-----------------
A Multi-center, Randomized, Double-blind, Parallel Phase Ⅳ Study to Explore the Efficacy of Statin/Choline Fenofibrate Combination Therapy vs Statin Monotherapy in Patients With Inadequately Controlled TG Despite Receiving Statin Monotherapy

Conditions
-----------------
Dyslipidemias

Intervention / Treatment
-----------------
* Drug: Fenofibrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: both male and female who are over 19-year-old 200mg/dl≤TG<500mg/dl Desired value of LDL-c very high risk < 70 high risk < 100 moderate risk <130 low risk < 160 Exclusion Criteria: patient who is going to have an operation during this study patient who has allergy or hypersensitivity of fenofibrate patient who has abnormal ECG

Ages Eligible for Study
-----------------
Minimum Age: 19 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: statin / fenofibrate<br>stable statin(rosuvastatin 10mg or atorvastatin 10mg or atorvastatin 20mg)+ choline fenofibrate 178.8mg / once a day, P.O | Drug: Fenofibrate<br>* statin(rosuvastatin 10mg or atorvastatin 10mg or atorvastatin 20mg) + choline fenofibrate vs statin(rosuvastatin 10mg or atorvastatin 10mg or atorvastatin 20mg) + choline fenofibrate placebo / once a day, P.O<br>* Other names: placebo;|
| Placebo Comparator: statin / fenofibrate placebo<br>stable statin(rosuvastatin 10mg or atorvastatin 10mg or atorvastatin 20mg) + choline fenofibrate placebo / once a day, P.O | Drug: Fenofibrate<br>* statin(rosuvastatin 10mg or atorvastatin 10mg or atorvastatin 20mg) + choline fenofibrate vs statin(rosuvastatin 10mg or atorvastatin 10mg or atorvastatin 20mg) + choline fenofibrate placebo / once a day, P.O<br>* Other names: placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of change for Triglyceride based on baseline |  | 8week |
Compassionate Use of Erwinase For Pediatric Patients With Acute Lymphoblastic Leukemia Or Non Hodgkins Lymphoma

Study Overview
=================
Brief Summary
-----------------
This is a compassionate use protocol for patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity or intolerance to E. coli L-asparaginase and/or PEG-L-asparaginase.

Detailed Description
-----------------
Primary Objective To provide Erwinase to patients with acute lymphoblastic leukemia (ALL) or non-Hodgkins lymphoma who are intolerant or have developed hypersensitivity to E. coli asparaginase and/or PEG-asparaginase. TREATMENT PLAN Erwinia L-asparaginase administration will be given according to the protocol or non-protocol treatment plan under which the patient is currently being treated. Erwinase will be discontinued in any patient experiencing an allergic reaction or any Grade 3 or higher adverse event believed to be attributable to this agent.

Official Title
-----------------
Compassionate Use of Erwinase For Pediatric Patients With Acute Lymphoblastic Leukemia Or Non Hodgkins Lymphoma

Conditions
-----------------
Acute Lymphoblastic Leukemia, Non Hodgkins Lymphoma

Intervention / Treatment
-----------------
* Drug: Erwinase


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients on treatment for acute lymphoblastic leukemia or non-Hodgkins lymphoma receiving ALL-type therapy who have developed hypersensitivity or intolerance to E. coli L-asparaginase or PEG-L-asparaginase or both. Informed consent explained to and signed by parent/legal guardian, with emphasis that although approved for use in Europe and Canada, Erwinase is NOT approved by the United States Food and Drug Administration Exclusion Criteria: Documented history of severe hypersensitivity or intolerance to Erwinase
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Erwinase<br>* Chemotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To provide Erwinase to patients with acute lymphoblastic leukemia (ALL) or non-Hodgkins lymphoma who are intolerant or have developed hypersensitivity to E. coli asparaginase and/or PEG-asparaginase |  | June 2009 |
Mesalazine Therapy in Patients With Irritable Bowel Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether Mesalazine is effective in the treatment of the abdominal discomfort or pain of Irritable Bowel Syndrome patients.

Detailed Description
-----------------
The present study is a prospective, double blind, randomised, multicenter trial designed to study the efficacy of mesalazine treatment on symptoms of IBS. In a subgroup of patients the efficacy of this treatment will be also assessed on low-grade inflammation. We expect to confirm that mesalazine treatment reduces the number and activation of inflammatory cells in the colonic mucosa of IBS patients, thus providing the rationale for the assessment of this treatment on symptoms of IBS.

Official Title
-----------------
A Randomised Controlled Multicenter Trial Assessing the Efficacy and Safety of Mesalazine Therapy in Patients With Irritable Bowel Syndrome.

Conditions
-----------------
Irritable Bowel Syndrome

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: IBS patients with positive diagnosis inclosing Rome III criteria Exclusion Criteria: Any organic or metabolic disease

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Mesalazine cpr 800 mg t.i.d. for 12 weeks | Drug: Mesalazine<br>* Mesalazine 800mg t.i.d. 12 weeks<br>* Other names: Pentacol 800, Sofar;|
| Placebo Comparator: B<br>Placebo cpr t.i.d. for 12 weeks | Drug: Placebo<br>* Placebo cpr, t.i.d. 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder is the patient who affirmatively answers on at least 50% of the weekly question:Did you have satisfactory relief of your abdominal discomfort or pain during the last week?. |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder is the patient who affirmatively answers on at least 50% of the weekly question:Did you have satisfactory relief of your overall IBS symptoms during the last week?. VAS scale IBS-QoL questionnaire and SF-36 questionnaire |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mesalazine in Irritable Bowel Syndrome
Discovering Novel Cancer Treatment Options Using a Comprehensive NGS-based Molecular Testing Panel in the Community Setting (DINOSAur)

Study Overview
=================
Brief Summary
-----------------
To prospectively identify cancer patients whose tumors express specific molecular markers targeted by therapeutic agents from a comprehensive molecular test, for the purpose of selecting the most clinically appropriate treatment in a pragmatic two arm trial.

Official Title
-----------------
Discovering Novel Cancer Treatment Options Using a Comprehensive NGS-based Molecular Testing Panel in the Community Setting (DINOSAur)

Conditions
-----------------
Stage III Solid Tumors, Stage IV Solid Tumors

Intervention / Treatment
-----------------
* Diagnostic Test: Comprehensive molecular panel test
* Other: EORTC QLQ-30


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have given informed consent in accordance with the methods and procedures of this study Diagnosis of cancer (stage 3 and stage 4; solid tumors only) requiring medical care Patients who have not received treatment related to his/her cancer Patients who are willing to sign a release of medical records to the research team Male and female patients ≥18 years of age Patients under oncology care of a participating site Sufficient clinical status for collection of biospecimen samples within usual care Patients who have insurance coverage for CMT Exclusion Criteria: Patients considered minors in the jurisdiction where the protocol is conducted. Patients who are prisoners and pregnant women. Patients who cannot provide consent and did not sign a power of attorney.

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 |
| --- | --- |
| Active<br>Newly diagnosed cancer patients. | Diagnostic Test: Comprehensive molecular panel test<br>* Lab test<br>Other: EORTC QLQ-30<br>* Quality of life questionnaire<br>|
| Control<br>Historically diagnosed cancer patients. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| European Organization for Research and Treatment of Cancer quality of life Questionnaire-C30 (QLQ-C30) | The EORTC Core Questionnaire (QLQ-C30) includes six clearly distinguishable functioning scales that have been thoroughly tested and validated on an international level and that are available in 110 different language versions. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the proportion of patients enrolling in clinical trials | To compare the proportion of enrolling in clinical trials between cancers patients who received the CMT versus cancer patients with no CMT. | 2 years |