linjc16/ctgov huggingface dataset:
Neutrophil Extracellular Traps Mediate Antiphospholipid Antibody-induced Pregnancy Loss

Study Overview
=================
Brief Summary
-----------------
Establish a multi-platform detection system for neutrophil extracellular traps in blood and tissues, and evaluate the detection performance; Comparing the expression levels of neutrophil extracellular traps in peripheral blood and decidua of patients with antiphospholipid antibody-induced pregnancy loss and normal control group; Comparing the expression levels of neutrophil extracellular traps in peripheral blood and decidua of mice with antiphospholipid antibody-induced pregnancy loss and normal control group; After treatment of antiphospholipid antibody-induced mouse abortion model with metformin,the effect of metformin on embryo loss rate and viable embryo body weight was observed.

Official Title
-----------------
Neutrophil Extracellular Traps Mediate Antiphospholipid Antibody-induced Pregnancy Loss

Conditions
-----------------
Neutrophil Extracellular Traps; Antiphospholipid Antibody-induced Pregnancy Loss

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Recurrent spontaneous abortion Clinical diagnosis of Antiphospholipid syndrome Exclusion Criteria: Other autoimmune diseases Hematopoietic system diseases Cardiovascular system diseases Gastrointestinal system diseases Urinary system diseases Nervous system or mental diseases Have taken other drugs recently

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 41 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pregnancy loss group<br>the times of pregnancy loss more than or equal to twice | |
| normal control group<br>no history of pregnancy loss | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NETs level | Neutrophil extracellular traps (NETs) are networks of extracellular fibers, primarily composed of DNA from neutrophils, which bind pathogens. | through study completion, an average of 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete blood count (CBC) | CBC is a blood panel requested by a doctor or other medical professional that gives information about the cells in a patient's blood, such as the cell count for each blood cell type and the concentrations of hemoglobin. | through study completion, an average of 8 months |
To Study the Absorption, Distribution, Metabolism and Excretion of AZD1305

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn more about how AZD1305 is handled by the body, i.e the absorption, distribution, metabolism and excretion of AZD1305.

Official Title
-----------------
A Phase I, Open, Randomised, Single-Centre, Crossover Study to Assess the Absorption, Distribution, Metabolism and Excretion (ADME) After Oral and Intravenous Administration of 14C-labelled and Non-labelled AZD1305 to Healthy Male Volunteers

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

Intervention / Treatment
-----------------
* Drug: AZD1305
* Drug: AZD1305


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers A body mass index (BMI=weight/height2) of 19 to 30 kg/m2 Exclusion Criteria: Potassium outside normal reference values ECG findings outside normal range

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 55 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: A<br>AZD1305 given as oral solution | Drug: AZD1305<br>* oral solution, single dose<br>|
| Experimental: B<br>AZD1305 given as iv infusion | Drug: AZD1305<br>* iv infusion, single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic variables |  | During all dosing visits | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events, vital signs, ECG, laboratory variables and physical examination |  | During the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AZD1305, ADME, pharmacokinetic, Absorption, distribution, metabolism, excretion
New Proteins in Body Fluids as Potential Biomarker for Alzheimer's Disease: a Pilot Study

Study Overview
=================
Brief Summary
-----------------
Alzheimer's disease (AD) is the most common neurodegenerative disorder afflicting the elderly. Currently, some biochemical tests performed on Cerebrospinal Fluid (CSF) samples have demonstrated to discriminate to some extend between AD and non-AD individuals based on the levels of tau, phospho-tau or Aβ42. We aim to investigate newly identified proteins whose levels increase during the Braak Stages of AD that are accessible in other body fluids such as blood, urine or saliva. The detection of these proteins would allow performing simple tests in case its levels were confirmed to be associated with the AD pathology.

Detailed Description
-----------------
We do not desire to provide a more extensive description

Official Title
-----------------
New Proteins in Body Fluids as Potential Biomarker for Alzheimer's Disease: a Pilot Study

Conditions
-----------------
Alzheimer Disease, Late Onset

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - mild to moderate AD Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| AD patients<br>Subject fulfilling the McKhann criteria for clinical probable AD | |
| Healthy elder persons<br>Healthy controls with abscence of any cognitive disorder | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in blood, saliva and urine protein levels in patients with Alzheimer's Disease versus healthy controls. | Protein levels will be measured by classical immunoblotting blot analysis and quantified; Classical statistical analyses will be performed in order to detect any significant differences. | Up to 1 year |
Cyclosporine Inhalation Solution (CIS) in Lung Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
Currently there are no approved therapies for lung transplant recipients in the United States (US). Treatment with CIS following lung transplantation has previously been demonstrated to result in a clinically meaningful improvement in survival and chronic rejection-free survival compared to placebo, but additional data supporting its use is needed prior to Food and Drug Administration (FDA) approval. This treatment use protocol is a mechanism for providing eligible lung transplant recipients early access to CIS in advance of FDA approval.

Official Title
-----------------
An Open-label Treatment Use Protocol of Cyclosporine Inhalation Solution (CIS) in Lung Transplant Recipients

Conditions
-----------------
Lung Transplant

Intervention / Treatment
-----------------
* Drug: Cyclosporine Inhalation Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Single-or double-lung transplant recipients who have a high risk for developing chronic rejection Single or double-lung transplant recipients who have developed chronic rejection Single or double-lung transplant recipients who have serious or life-threatening complications of systemic immunosuppressive therapy Exclusion Criteria: Known hypersensitivity to cyclosporine or propylene glycol (PG) Females who are pregnant or are considering becoming pregnant Females who are breast feeding a child.
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Cyclosporine Inhalation Solution|Cyclosporine USP Inhalation Solution (CIS) 300mg/4.8 mL delivered via a disposable nebulizer. A titration phase of 10 days is recommended starting with 100 mg and then increasing over the 10 days to a maximum of 300 mg or the highest tolerated dose.|

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
-----------------
lung, transplant, transplant rejection, Cyclosporine, bronchiolitis obliterans, aerosol
Analysis of Thrombo-embolic Complications After Endovascular Treatment of Unruptured Intracranial Aneurysms

Study Overview
=================
Brief Summary
-----------------
Endovascular treatment of ruptured and unruptured intracranial aneurysms presents complications, mainly the thrombo-embolic complication. No specific studies have been conducted to study factors associated with the occurrence of thromboembolic complications (symptomatic or not) post endovascular treatment of intracranial aneurysms.

Detailed Description
-----------------
In this multicenter, prospective study, patients with treatment of unruptured intracranial aneurysms will be recruited. The thromboembolic complications will be research using diffusion-weighted MRI.

Official Title
-----------------
Analysis of Thrombo-embolic Complications After Endovascular Treatment of Unruptured Intracranial Aneurysms

Conditions
-----------------
Unruptured Intracranial Aneurysms

Intervention / Treatment
-----------------
* Other: diffusion-weighted MRI and clinical examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient having a programmed endovascular treatment for unruptured intracranial aneurysm patient older than 18 years patient consenting to participate to the study patient enrolled in the national healthcare insurance program Exclusion Criteria: patients with contraindications for MRI patients whose clinical condition does not allow sufficient cooperation to the realization of MRI patients with arteriovenous malformation intracranial

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patient with endovascular treatment<br> | Other: diffusion-weighted MRI and clinical examination<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thromboembolic complication | Thromboembolic complication diagnosed using diffusion-weighted MRI | 72 hours after endovascular treatment |
Gender-specific aEEGs and Outcome in Preterms

Study Overview
=================
Brief Summary
-----------------
Background and objectives: Male sex is a risk factor for poor neurodevelopmental outcome following preterm birth. The investigators aimed to investigate gender-related differences in amplitude-integrated electroencephalography (aEEG) and to correlate these findings with neurodevelopmental outcome. Methods: Preterm infants born <30 weeks' gestational age between 2000 and 2002 were prospectively included. aEEGs obtained within the first two weeks of life were evaluated and classified according to background activity, sleep-wake cycling (SWC) and seizure activity. Outcome was assessed at three years.

Official Title
-----------------
Gender-related Differences in Early Amplitude-integrated Electroencephalography in Newborns < 30 Weeks' Gestational Age and Their Correlation With Neurodevelopment Outcome at Three Years Corrected Age

Conditions
-----------------
Gender Role Disorder, Male to Female Type

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: born<30 weeks gestational age who had aEEGs in first 2 weeks of life who were assessed for outcome at 3 years of age Exclusion Criteria: born>30 weeks gestational age had no aEEGs in first 2 weeks of life lost for follow-up at 3 years

Ages Eligible for Study
-----------------
Minimum Age: 24 Weeks
Maximum Age: 30 Weeks

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 |
| --- | --- | --- |
Intratumoural Administration of Coxsackievirus A21 for the Control of Malignant Melanoma (PXS-X02)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety of an injection of coxsackievirus A21 into a melanoma tumour, and also to see if there is a tumour response.

Detailed Description
-----------------
Coxsackievirus A21, a naturally occurring enterovirus, has shown that in vivo it can infect and lyse melanoma. This study is to assess safety of a single intratumoural injection of the virus into an accessible subcutaneous melanoma metastasis.

Official Title
-----------------
Intratumoural Administration of Coxsackievirus A21 for the Control of Malignant Melanoma (PXS-X02)

Conditions
-----------------
Malignant Melanoma

Intervention / Treatment
-----------------
* Drug: Coxsackievirus A21


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stage IV melanoma (AJCC classification) minimum of 2 sc metastases failure or refusal of standard chemotherapy ECOG score of 0 or 1 other Exclusion Criteria: metastatic CNS disease ocular or mucosal melanoma immunodeficiency splenectomy other

Ages Eligible for Study
-----------------
Minimum Age: 21 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
Intervention Model: Single Group Assignment
Interventional Model Description: CAVATAK
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Coxsackievirus A21|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety profile of treatment, characterisation of adverse events |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy - clinical response of injected and non-injected tumours |  |  |
Propranolol in Severely Burned Children

Study Overview
=================
Brief Summary
-----------------
To determine the safety and efficacy of administration of propranolol for reducing heart rate and blood pressure in burn injury.

Detailed Description
-----------------
Other purposes of this study are to study the effect on muscle function, the infectious process, sepsis, systemic inflammation and long-term scarring. Quality of life will also be looked at over time.

Official Title
-----------------
Safety and Efficacy of Propranolol in Severely Burned Children

Conditions
-----------------
Burn

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Burns covering >20% of the total body surface are Age of 0 to 18 years Patient arrival to the burn center within 96 hours (4 days) of burn injury Require > 1 surgical procedure Exclusion Criteria: Pregnancy Known history of AIDS, Aids Related Complex, or HIV History of cancer within 5 years Existence of pre-morbid conditions Asthma Congestive heart failure (measured ejection fraction < 20%) Medical condition requiring glucocorticoid treatment Burn injury due to chemical burns Burn injury due to deep electrical injury (decision of hospital PI) Presence of anoxic brain injury that is not expected to result in complete recovery Decision not to treat due to burn injury severity

Ages Eligible for Study
-----------------
Maximum 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propranolol<br>Propranolol by mouth given daily throughout hospitalization for up to 12 months | Drug: Propranolol<br>* Propranolol by mouth given daily throughout hospitalization for up to 12 months<br>* Other names: inderal;|
| Placebo Comparator: Sugar Pill<br>Placebo by mouth given daily throughout hospitalization for up to 12 months | Drug: Placebo<br>* Placebo by mouth given daily throughout hospitalization for up to 12 months.<br>* Other names: Control;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resting heart rate multiplied by the systolic blood pressure measurement= rate pressure product | Multiply the subjects resting heart rate and systolic blood pressure measurements and average every 24 hours while hospitalized (an average of 4 weeks) | Measured during acute hospital stay, an average of 4 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of deaths | Number of deaths will be compared between placebo group and propranolol treatment groups. | time of randomization up to one year |
Impact of Pulmonary Follow-up After Stem Cell Graft

Study Overview
=================
Brief Summary
-----------------
Allogeneic hematopoietic stem cell transplantation is the only possible treatment for many malignant and non-malignant hemopathies. The graft-versus-host immunological reaction (GvH) is a frequent and sometimes serious complication. The objective is to study whether a systematic and early follow-up by a lung specialist of allografted patients would allow an earlier diagnosis of GvH with pulmonary complications.

Official Title
-----------------
Impact of Systematic Pulmonary Follow-up After Hematopoietic Stem Cell Transplantation

Conditions
-----------------
Hematologic Neoplasms

Intervention / Treatment
-----------------
* Procedure: Hematopoietic stem cell transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older patients with a hematopoietic stem cell transplantation Exclusion Criteria: Death within 100 days post-surgery

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Hematopoietic stem cell transplantation|Hematopoietic stem cell transplantation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical complications | 100 days after allograft | Medical complications, especially Graft-versus-Host reaction with pulmonary complications occurring within 100 days post-surgery are studied |
Prospective Multicentric Study of Cytomegalovirus Resistance in Transplant Patients and Bone Marrow Recipients

Study Overview
=================
Brief Summary
-----------------
The investigators aim is to determine the incidence of cytomegalovirus resistance to antivirals in a cohort study. The patients are included at their first CMV active infection and are followed during two years thereafter. When criteria for suspected resistance are meet, blood and urine samples are collected for virus isolation and further resistance phenotype, and for resistance genotype determination. Results are compared with baseline samples. Clinical information such as treatment, immunosuppressive regimen and clinical evolution will be collected. Through this study, the investigators aim to organize a national network for the detection and identification of CMV resistant strains that will be useful when new therapeutics will be available.

Official Title
-----------------
Cytomegalovirus Resistance in Transplant Patients and Bone Marrow Recipients in the Prophylaxis Era, a French Multicentric Cohort Study

Conditions
-----------------
Cytomegalovirus

Intervention / Treatment
-----------------
* Biological: depistage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Allogeneic bone marrow transplant recipient or solid organ transplant recipient, included in the cohort at the time of its firs active CMV infection (ie biological signs of CMV replication (viremia, ADN or ARN aemia, Antigenaemiapp65….) with or without fever, or clinical end organ disease symptoms Exclusion Criteria: Patient without medical care.policy, patient that did not signed the médical consent
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: depistage|Virus isolation from urine, blood, or any suitable sample in case of CMV disease Resistance phenotype to antivirals UL97 and UL54 genes sequencing from blood, urines or any suitable samples for resistance mutations detection and polymorphism study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resistance incidence in our patients with subgroup analysis, by organ and by the use of prophylaxis or preemptive treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Strain diversity in baseline isolates and in resistant isolates Frequency of known resistance mutations Identification of new resistance-related mutations. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cytomegalovirus, resistance, transplantation, Patient coming to an French transplantation center for solid organ or bone marrow transplant, with information and signed consent