linjc16/ctgov huggingface dataset:
A Bioequivalence Study of Serum Free Avonex and Serum Containing Avonex in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
Demonstrate the bioequivalence of a serum-free solution to a serum containing solution of Avonex.

Official Title
-----------------
A Randomized, Single-Blind, Crossover Study in Healthy Volunteers to Demonstrate the Bioequivalence of AVONEX® (Interferon Beta-1a) Solutions for Injection Produced by a Serum-Containing Manufacturing Process and by a Serum-Free Manufacturing Process

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: Serum containing Avonex
* Drug: Serum Free Avonex


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Volunteers Exclusion Criteria: History of severe allergic or anaphylactic reactions History of hypersensitivity to acetaminophen (paracetamol), ibuprofen, or codeine. Known allergy to dry natural rubber History of seizure disorder or unexplained blackouts History of any clinically significant (as determined by the Investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease Other inclusion and exclusion criteria apply as per protocol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1<br>Serum containing Avonex followed by serum free Avonex | Drug: Serum containing Avonex<br>* 60mcg IM dose of serum containing Avonex on Day 1, followed by 60mcg IM dose of serum free Avonex on Day 15<br>* Other names: Avonex;|
| Experimental: Sequence 2<br>Serum free Avonex followed by serum containing Avonex | Drug: Serum Free Avonex<br>* 60mcg IM dose of serum free Avonex on Day 1, followed by 60mcg IM dose of serum containing Avonex on Day 15.<br>* Other names: Avonex;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate the bioequivalence of a serum-free Avonex and a serum-containing AVONEX® when given intramuscularly (IM) to healthy volunteers. |  | Study duration is 72 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Sclerosis, Interferon beta-1a
Analysis of the Potentially Parasitocidal Effect of a Long Term Chemotherapy With Benzimidazoles

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate PET-CT and EmII/3-10 serology as potential markers to assess the parasitocidal effect of benzimidazoles Trial with medicinal product

Official Title
-----------------
Analysis of the Potentially Parasitocidal Effect of a Long Term Chemotherapy With Benzimidazoles in Patients With Inoperable Alveolar Echinococcosis Using PET-CT and EmII/3-10 Serology

Conditions
-----------------
Alveolar Echinococcosis

Intervention / Treatment
-----------------
* Other: Stop treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients with inoperable alveolar echinococcosis With negative PET-CT EmII/3-10 serology under long-term chemotherapy with benzimidazoles Exclusion criteria: Positive PET-CT Positive EmII-3-10 Serology No compliance Reduced life expectancy Pregnancy

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

| Intervention/Treatment |
| --- |
|Other: Stop treatment|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Use of Lapis Judaicus to Dissolve Kidney Stones

Study Overview
=================
Brief Summary
-----------------
The investigators will investigate the safety and effectiveness of an Iranian traditional medicine regarding its ability to dissolve existing kidney stones. Calcium stone formers will be recruited for a 12 week trial. Each subject will receive Lapis judaicus or placebo in random order. End points are changes in urinary chemistries and stone burden by Ultra sonography / CT scan. It will be used in proven calcium stone forming adults who are not pregnant. This phase is a double blind, randomized, placebo controlled Entry, first and 12 week 24 hour urine supersaturations, pH and sodium determinations will be collected. Entry and final stone quantification Ultra sonography / CT scan will be performed. End points will be changes in urine chemistry/supersaturation and stone quantitative stone volume.

Conditions
-----------------
Kidney Calculi

Intervention / Treatment
-----------------
* Drug: Lapis Judaicus
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 or over Mentally competent Medically effective birth control if fertile female History of calcium containing stone AND current quantifiable stone Able to comply with protocol Exclusion Criteria: Prisoner Pregnant CKD

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 2 g capsule per day.<br>|
| Active Comparator: Lapis judaicus<br> | Drug: Lapis Judaicus<br>* 2 g capsule per day.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stone size after 12 weeks | 24 hour urine chemistries 24 hour urine supersaturation Stone quantification CT | 8 weeks and 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney Calculi, Iranian traditional medicine, Lapis judaicus
Ultrasound Image Fusion for Placement of Sacral Quadripolar Leads

Study Overview
=================
Brief Summary
-----------------
Determine the ability of real-time ultrasound with fusion technology of prior acquired MRI of the pelvis to guide a needle to the second sacral foramen using the posterior approach and place a interstim lead.

Official Title
-----------------
Real-time Ultrasound Guided Placement of Sacral Quadripolar Leads With Ultrasound Image Fusion of Acquired Magnetic Resonance Scan (MRI)

Conditions
-----------------
Urinary Incontinence

Intervention / Treatment
-----------------
* Procedure: Placement of interstim lead


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient consented for Interstim lead placement Exclusion Criteria: Patients requesting not to be in the study. Pregnant patients

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- |
| Other: Placement of interstim lead<br>Placement of interstim lead using US image fusion technology | Procedure: Placement of interstim lead<br>* Placement of insterstim lead using US image fusion technology<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify the third sacral foramen of the pelvis through US image fusion technology |  | at time of procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
urinary incontinence
A Study of the Effect of Aldurazyme® (Laronidase) Treatment on Lactation in Female Patients With Mucopolysaccharidosis I (MPS I) and Their Breastfed Infants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if laronidase is present in the breast milk of post-partum women receiving Aldurazyme® (laronidase) and the effects of Aldurazyme (laronidase) on the growth, development, and immunologic response of their breastfed infants.

Detailed Description
-----------------
Recruitment is not limited to the facility listed; facilities not yet active may be added upon identification of a patient.

Official Title
-----------------
A Multicenter, Multinational, Open-Label Study of the Effects of Aldurazyme (Laronidase) Treatment on Lactation in Women With Mucopolysaccharidosis I (MPS I) and Their Breastfed Infants

Conditions
-----------------
Mucopolysaccharidosis I, Hurler's Syndrome, Hurler-Scheie Syndrome, Scheie

Intervention / Treatment
-----------------
* Biological: Aldurazyme (laronidase)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (Mothers): The patient must have a documented laronidase deficiency with a fibroblast, plasma, serum, leukocyte, or dried blood spot laronidase enzyme activity assay. Be pregnant, planning to breastfeed post-partum, and receiving Aldurazyme (laronidase) therapy while breastfeeding. Provide signed, written informed consent prior to any protocol-related procedures. Consent of a legally authorized guardian(s) is (are) required for mothers younger than 18 years of age. If a mother is under 18 years old and can understand the consent, written informed consent is required from both the mother and the authorized guardian(s). Provide signed, written informed consent for their infants to participate as study patients. If a mother is younger than 18 years of age, consent for mother and infant will be obtained from the legal guardian. Exclusion Criteria (Mothers and Infants): Have a medical condition, serious intercurrent illness, or other extenuating circumstance that may interfere with study compliance, including all prescribed evaluations and follow-up activities. Have received an investigational drug within 30 days prior to study enrollment.
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Aldurazyme (laronidase)|dose of 0.58mg/kg body weight intravenously (IV) every week|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast milk samples for laronidase, Immunogenicity Testing, and Urinary glycosaminoglycans (uGAG). |  | Up to 18 months |
Study of Immunity Dysfunction Induced by Extracorporeal Assistance (ECMO / ECLS)

Study Overview
=================
Brief Summary
-----------------
Study of immunosuppression biomarkers in patients with ARDS or cardiogenic shock with ECMO / ECLS, compared to patients with ARDS or cardiogenic shock without ECMO / ECLS

Official Title
-----------------
Study of Immunity Dysfunction Induced by Extracorporeal Assistance (ECMO / ECLS)

Conditions
-----------------
Acute Respiratory Distress Syndrome, Cardiogenic Shock

Intervention / Treatment
-----------------
* Biological: Blood test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient older than 18 years old Patient hospitalized in an intensive care unit Patient whose initial ARDS or Cardiogenic shock began less than 5 days before admission Patients hospitalized for ARDS or Cardiogenic shock with ECMO / ECLS or - Patients hospitalized for ARDS or Cardiogenic shock without ECMO / ECLS Exclusion Criteria: Opposition of patient, relative or legal representative for participation in the study Pregnant woman Pre-immunodepression Implementation of immunosuppressive therapy such as chemotherapy, cyclophosphamide, high-dose corticosteroids (> 0.5mg / kg / day).

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 |
| --- | --- |
| ECMO / ECLS<br>Patients hospitalized for ARDS or Cardiogenic shock with ECMO / ECLS | Biological: Blood test<br> <br> |
| No ECMO / ECLS<br>Patients hospitalized for ARDS or Cardiogenic shock without ECMO / ECLS | Biological: Blood test<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of immunosuppression in patients with ARDS or cardiogenic shock under ECMO / ECLS hospitalized in intensive care unit |  | Hour 24 |
Low-Dose Naltrexone for the Treatment of Complex Regional Pain Syndrome

Study Overview
=================
Brief Summary
-----------------
The investigators are testing treatment with low-dose naltrexone (LDN) for symptom relief of complex regional pain syndrome (CRPS). Study participants will be randomly assigned to receive either LDN or placebo for a period of several weeks. During this period participants will be asked to attend either in-person or virtual study visits and complete questionnaires.

Official Title
-----------------
Low-Dose Naltrexone for the Treatment of Complex Regional Pain Syndrome

Conditions
-----------------
Complex Regional Pain Syndrome

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Upper and/or lower extremity CRPS On stable treatment for 1 month CRPS for at least 1 year Meet the Budapest criteria for CRPS at time of the study. Exclusion Criteria: Any known allergy to naltrexone or naloxone Use of prescription opioid analgesics or illegal opioid use Current or planned pregnancy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: LDN<br>Naltrexone HCL, 4.5 mg, Once a day. | Drug: LDN<br> <br> |
| Placebo Comparator: Placebo<br>Sugar pill | Drug: Placebo<br>* Sugar pill<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in pain severity | Daily pain reports on a 0-10 numerical rating scale for pain, where 0=no pain and 10=pain as bad as you can imagine | Approximately 4 weeks after conclusion of treatment. |
Endophthalmitis After Intravitreal Injection of Antiangiogenic Agents or Corticosteroids, a Cohort Study of the French Population of Patients Who Received Injections Over 9 Years

Study Overview
=================
Brief Summary
-----------------
Intravitreal injections (IVI) of antiangiogenic agents (AA) have revolutionized the management of age-related macular degeneration (AMD) and diabetic macular edema (DME) in particular. Approximately 600,000 AA IVIs are performed each year in France. Corticosteroid IVIs are an alternative in the treatment of macular edema when it is diabetic or related to venous occlusion, but also due to inflammation. Endophthalmitis is one of the most feared complications after IVI because of its poor prognosis, despite its low incidence (values found in the literature between 0.01% and 0.08%). IVI practices have evolved over the years based on the recommendations of specialized organizations, with the current recommendation not to use antibiotic prophylaxis. The purpose of this study is to study the effect of intravitreal injections of anti-angiogenic agents and corticosteroids on the occurrence of endophthalmitis within 28 days following an injection.

Official Title
-----------------
Endophthalmitis After Intravitreal Injection of Antiangiogenic Agents or Corticosteroids, a Cohort Study of the French Population of Patients Who Received Injections Over 9 Years

Conditions
-----------------
Intravitreal Injection

Intervention / Treatment
-----------------
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients within the French population who had an intravitreal injection, identified by CCAM coding BGLB001 associated with the delivery of an anti-angiogenic agent or a corticosteroid, identified by the corresponding CIP code between February 2007 and November 2015 Exclusion Criteria: intraocular surgery less than 42 days before the first injection, identified by the CCAM procedure risk factors for endogenous endophthalmitis identified in the 42 days preceding an IVI identified by the ICD10 code

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

| Intervention/Treatment |
| --- |
|Other: Data collection|Sociodemographic, medical and hospital, on ambulatory care consumption data.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of occurrence of endophthalmitis |  | Up to 28 days following an intravitreal injection |
IL-35+Breg/Il-35 Effect on T Cell Immune in Patients With CHB

Study Overview
=================
Brief Summary
-----------------
The investigators observed the level of IL-35 secreting B regulatory (IL-35+Bregs) cells in peripheral blood cells in patients with chronic hepatitis B, and analysed the relationship between the IL-35+Bregs level and disease stage, and Th1 and Th2 cells level.

Detailed Description
-----------------
Regulatory B cells (Bregs) are involved in the immune tolerance process through multiple pathways and Bregs are involved in the process of chronic HBV infection. Here the investigators intended to investigate the regulating role and the mechanism of CD19+ IL-35+ cells on host T cell immune during chronic HBV infection by using in vitro cell sorting, B cell differentiation induction, Transwell cell co-culture system and other methods.

Official Title
-----------------
Regulate Effect of Il-35 Secreting Breg Cells on Tcells and on Diseases Progression in Patients With CHB

Conditions
-----------------
Chronic Hepatitis b

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of chronic hepatitis B virus infection 17<age<70 Can read, understand and sign patients informed consent Exclusion Criteria: Co-infection with HCV,HIV,HDV etc. Have malignancy Have uncontrollable extra-hepatic disease

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 70 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 |
| --- | --- |
| Patients<br>HBsAg positive more than 6 months | |
| health control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IL-35+Bregs level | IL-35 secreting regulatory B cells level in patients with CHB | ENROLLED DAY | 
| IL-35+Bregs regulatory effect | regulatory effect of IL-35+Bregs on T cell immune | enrolled day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IL-35+Bregs phenotype | the main phenotype of IL-35 secreting Bregs | enrolled day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic hepatitis B, regulating B cells, T help 17 cells, Interleukin 35
Pediatrics:Chlamydia, Sickle Cell Anemia and Stroke Risk - Ancillary to STOP II

Study Overview
=================
Brief Summary
-----------------
To establish a link among Chlamydia infection, sickle cell anemia, and stroke risk.

Detailed Description
-----------------
BACKGROUND: Infection with Chlamydia pneumoniae (C. pneumoniae) is associated with an increased risk of cerebrovascular disease in the general population. Children with sickle cell anemia (SCA) are 200 times more likely to have cerebrovascular disease than normal children and are known to have an altered immune response to many infectious pathogens. C. pneumoniae is the leading infectious cause of acute chest syndrome which, interestingly, is a well- established risk factor for stroke in children with SCA. Preliminary data indicates that SCA patients with magnetic resonance imaging (MRI)-documented cerebral infarction are 12 times more likely to have C. pneumoniae infection than SCA patients with normal MRI scans. The investigators hypothesize that SCA patients have an abnormal immune response to C. pneumoniae that results in persistent infection which, in turn, triggers the development of cerebrovascular disease. Sickle cell anemia patients with an elevated velocity on transcranial doppler ultrasound (TCD) are known to be at high risk to develop stroke and an elevated TCD likely reflects underlying vascular disease. In addition, the Stroke Prevention in Sickle Cell Anemia Trial (STOP) demonstrated that almost 40 percent of children with an elevated TCD have evidence of cerebral infarction on MRI. Children with abnormal TCDs are, therefore, an appropriate population to investigate an association between cerebrovascular disease and C. pneumoniae infection. The study is in response to an initiative on Ancillary Studies in Heart, Lung, and Blood Disease Trials released in June, 2000. DESIGN NARRATIVE: The study is ancillary to the STOP II clinical trial. The intent is: 1) To determine if C. pneumoniae infection is associated with cerebral infarction in children with SCA; 2) To characterize the immunological response to C. pneumoniae infection in patients with SCA. Establishing a link between C.pneumoniae infection and cerebral infarction will open the door to novel, less toxic approaches to the treatment and prevention of stroke in SCA, including antibiotics and vaccines.

Conditions
-----------------
Blood Disease, Anemia, Sickle Cell, Chlamydia Infections, Cerebrovascular Accident

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 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 |
| --- | --- | --- |