linjc16/ctgov huggingface dataset:
Chronic Granulomatous Disease Study in China

Study Overview
=================
Brief Summary
-----------------
CGD is a rare inherited primary immunodeficiency which is caused by the defect in one of the subunits of NADPH oxidase complex.We tend to collect and analyze Chinese CGD patients who are diagnosed in hospitals affiliated to Shanghai Jiao Tong University School of Medicine, including clinical feature, laboratory data and genetic information. we aim to find out clinical, distribution, genetic characteristic of CGD in Chinese population, etc., thus further improving the level of diagnosis and treatment for CGD.

Conditions
-----------------
Granulomatous Disease, Chronic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: x-linked and AR-linked Chronic Granulomatous Disease history of life-threatening severe infections A functional assay demonstrating abnormal NADPH oxidase function or clinical history consistent with CGD Exclusion Criteria: Presence of other primary immunodeficiency syndromes that do not meet the clinical and laboratory criteria for CGD.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum 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 |
| --- | --- |
| gene mutation<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| times of pneumonia |  | 2 years |
PEG-rhG-CSF in Patients With Breast Cancer Receiving Chemotherapy to Prevent Neutropenia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to estimate the efficacy and safety of PEG-rhG-CSF in patients with breast cancer receiving chemotherapy.

Official Title
-----------------
A Multi-center, Open-label,Single Arm Phase IV Clinical Trial of Efficacy and Safety of PEG-rhG-CSF in Preventing Neutropenia in Patients With Breast Cancer Receiving Chemotherapy

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: PEG-rhG-CSF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with age between 18 and 70 years diagnosis of breast cancer patients who need to receive multi-cycle chemotherapy grade III/IV neutropenia after chemotherapy KPS score≥70 life expectancy of at least 3 months Written informed consent are acquired Exclusion Criteria: Have accepted any other drug related clinical trial within 4 weeks before anticipated uncontrolled infection pregnancy Other situations that investigators consider as contra-indication for this study

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEG-rhG-CSF<br>patients received a single dose of 100 ug/kg of PEG-rhG-CSF(pegfilgrastim), on the basis of actual body weight, as a single subcutaneous injection on day 3 after chemotherapy | Drug: PEG-rhG-CSF<br> <br> * Other names: pegfilgrastim;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the occurrence rate of the adverse events that are related to treatment during four consecutive cycles chemotherapy |  | up to 30 days after the patient study completion | 
| the severity of the adverse events that are related to treatment during four consecutive cycles chemotherapy |  | up to 30 days after the patient study completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the occurrence rate of III/ IV neutropenia during the whole chemotherapy process |  | through the study completion,an average of 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PEG-rhG-CSF neutropenia
Registry for Patients With Wilms' Tumor Suppressor Gene 1 (WT1) Mutation Associated Diseases

Study Overview
=================
Brief Summary
-----------------
The Wilms' tumor suppressor gene 1 (WT1) encodes for a transcription factor which plays an important role during urogenital development. Patients carrying a WT1 germline mutation show symptoms like proteinuria, Wilms tumors, genital malformations and kidney failure. Milder variants are possible and classification is not always possible. In this registry we are collecting detailed clinical data of affected individuals to establish genotype-phenotype correlations with the greater goal to optimize patient care.

Detailed Description
-----------------
The Wilms' tumor suppressor gene 1 (WT1) encodes for a transcription factor which plays an important role during urogenital development. Patients carrying a WT1 germline mutation show symptoms like proteinuria, Wilms tumors, genital malformations and kidney failure, which usually occur in early childhood. Milder variants are possible and classification as one of the three rare syndromes associated with WT1 mutations (Denys-Drash syndrome, Frasier syndrome or WAGR syndrome) is not always possible. In this registry we are collecting detailed clinical data of affected individuals to establish genotype-phenotype correlations with the greater goal to optimize patient care.

Official Title
-----------------
Registry for Patients With WT1 Mutation Associated Diseases

Conditions
-----------------
Denys-Drash Syndrome, Frasier Syndrome, Nephrotic Syndrome, Wilms Tumor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Germline mutation in WT1 gene Exclusion Criteria: none
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
WT1, Wilms Tumor, Denys-Drash Syndrome, Nephrotic Syndrome, Proteinuria
Epidermal Growth Factor Receptor Mutations in the Blood of Patients With Advanced Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. PURPOSE: This laboratory study is looking at epidermal growth factor receptor mutations in the blood of patients with advanced non-small cell lung cancer.

Detailed Description
-----------------
OBJECTIVES: Determine if epidermal growth factor receptor (EGFR) mutation exists in the peripheral blood of patients with advanced non-small cell lung cancer (NSCLC). Estimate the frequency of EGFR mutation in these patients. Correlate the presence of EGFR mutation in blood with EGFR mutation in primary or metastatic NSCLC tumor block. OUTLINE: Patients undergo blood collection for analysis of epidermal growth factor receptor mutation by DNA sequencing. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Official Title
-----------------
Study of Mutations of Epidermal Growth Factor Receptor in the Blood of Patients With Advanced Non Small Cell Lung Cancer

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Genetic: molecular diagnostic method
* Genetic: mutation analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed advanced non-small cell lung cancer Must have available tumor tissue block PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified

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 |
| --- |
|Genetic: molecular diagnostic method|nan|
|Genetic: mutation analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Existence of epidermal growth factor receptor (EGFR) mutations in peripheral blood |  | Day 1 | 
| Frequency of EGFR mutation | Number of participants with EGFR mutation in tissue and plasma. | Day 1 | 
| Number of participants with EGFR mutation in peripheral blood and in tumor tissue. |  | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recurrent non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
Validation of Low Dose CT for Diagnosis of Lung Nodules

Study Overview
=================
Brief Summary
-----------------
The investigators have developed an extremely low dose computed tomography (CT) protocol that on preliminary testing has an effective dose in the range of two chest radiographs. The investigators plan to test this exam in patients with known or suspected cancer undergoing clinically indicated chest CT.

Official Title
-----------------
Validation of an Extremely Low Dose Computed Tomography Protocol for Diagnosing Lung Nodules in Children and Young Adults

Conditions
-----------------
Cancer, Metastasis to Lung

Intervention / Treatment
-----------------
* Diagnostic Test: Extremely Low Dose CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric and young adult patients (ages 4 to <21 years) Known or suspected malignancy other than lymphoma Undergoing clinically indicated CT of the chest Exclusion Criteria: Pregnancy identified by routine Department of Radiology verbal screening Prior enrollment in the same study (no patient will be enrolled more than once) Inability to provide consent and/or assent Lymphoma

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 20 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: Study Group<br>Patients will receive both the clinically indicated and extremely low dose exams | Diagnostic Test: Extremely Low Dose CT<br>* Patients undergoing a clinically indicated chest CT will also undergo the extremely low dose CT<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance of extremely low dose CT | Sensitivity | At time of imaging |
Investigating a Model for Acute Ischemic Pain in Humans

Study Overview
=================
Brief Summary
-----------------
The pathophysiology of acute ischemic pain is not well established. The aim of the present study was to investigate acute ischemic pain in humans with a view to establish a scientific model to perform future studies. The investigators examined whether peripheral nerve damage and acute inflammation occur during short episodes of acute ischemia.

Official Title
-----------------
Investigating a Model for Acute Ischemic Pain in Humans

Conditions
-----------------
Peripheral Arterial Disease

Intervention / Treatment
-----------------
* Other: acute ischemic pain


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients over 40 years unilateral femoral-popliteal PAD, Fontaine grade II Exclusion Criteria: patients with pain at rest or other pain origin diabetic polyneuropathy deep vein thrombosis

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Acute ischemic pain<br>acute ischemic pain was induced by treadmill testing in all patients investigated | Other: acute ischemic pain<br>* acute ischemic pain was induced by treadmill exercise<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Induce acute ischemic pain | To induce acute ischemic pain, patients performed treadmill exercise until intolerable pain developed. | during treadmill exercise (less than 15 minutes) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute ischemic pain, model, S100, interleukine 6
Efficacy and Safety of Resveratrol and Lipoic Acid Transdermal Patch for Lipolysis in Overweight Volunteers

Study Overview
=================
Brief Summary
-----------------
To evaluate the lipolysis effect of resveratrol and lipoic acid transdermal patch in overweight volunteers

Detailed Description
-----------------
66 participants with overweight received a resveratrol and lipoic acid transdermal patch treatment. The treatment areas have been treated including left and right arms. Subjects were evaluated using standardized measurements of body weight and circumference of arms at baseline and 2 weeks follow-up visits. Evaluation of physician were also measured.

Official Title
-----------------
Efficacy and Safety of Resveratrol and Lipoic Acid Transdermal Patch for Lipolysis in Overweight Volunteers

Conditions
-----------------
Lipolysis

Intervention / Treatment
-----------------
* Other: Resveratrol lipoic Acid
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy volunteers with BMI > 23 Exclusion Criteria: resveratrol or lipoic acid allergies

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resveratrol lipoic Acid<br>lipoic and resveratrol was loaded on the patch | Other: Resveratrol lipoic Acid<br>* Transdermal patch loaded with resveratrol and lipoic acid<br>|
| Experimental: Placebo<br>normal saline was loaded on transdermal patch | Other: Placebo<br>* Transdermal patch loaded with normal saline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fat thickness measured | fat thickness measurement by ultrasound | 2 weeks |
Study to Describe Risk of Bleeding in Patients Depending on the Different Anticoagulant Therapy They Are on for Atrial Fibrillation (AF)

Study Overview
=================
Brief Summary
-----------------
Study of patients with nonvalvular atrial fibrillation (NVAF) who are newly prescribed NOACs (Novel Oral Anticoagulants) in routine clinical practice in England

Official Title
-----------------
Investigating the Association of Type of Anticoagulation Treatment for Non-valvular Atrial Fibrillation and Risk of Bleeding in England

Conditions
-----------------
Non-valvular Atrial Fibrillation

Intervention / Treatment
-----------------
* Other: Non-interventional
* Other: Non-Interventional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of atrial fibrillation at or prior to index (the initiation of treatment) Incident prescription of an oral anticoagulant (index date) Patients with at least one year of computerized data prior to index date Exclusion Criteria: Patients identified with a diagnosis of mechanical heart valve replacement or mitral stenosis identified at any point in the pre-index period in either CPRD by Read codes or in HES as ICD-10/OPCS codes Patients with indication of venous thromboembolism (pulmonary embolism or deep vein thrombosis) identified in in either CPRD by Read codes or HES by ICD-10/OPCS codes within 3 months prior to index Other protocol defined inclusion/exclusion criteria could apply

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 |
| --- | --- |
| Participants with NVAF starting Apixaban<br> | Other: Non-interventional<br>* Non-interventional<br>|
| Participants with NVAF starting Warfarin<br> | Other: Non-Interventional<br>* Non-Interventional<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of major bleeding |  | At the end of 1 year | 
| Incidence of intracranial bleeding |  | At the end of 1 year | 
| Incidence of gastrointestinal bleeding |  | At the end of 1 year | 
| Incidence of clinically relevant non-major bleeding |  | At the end of 1 year | 
| Incidence of ischemic stroke |  | At the end of 1 year | 
| Incidence of unspecified stroke |  | At the end of 1 year | 
| Incidence of systemic embolic events |  | At the end of 1 year |
Population Pharmacokinetics and Metabolomics of Theophylline in Preterm Infants

Study Overview
=================
Brief Summary
-----------------
Population pharmacokinetics : The purpose of this study is - to investigate the population pharmacokinetics of theophylline in premature Korean infants and to assess the influence of demographic and clinical covariates. Metabolomics : The purpose of this study are to predict serum theophylline levels and to assess CYP1A2 activities in premature infants by analyzing urinary metabolites of theophylline to examine which factors affect clearance of theophylline and CYP1A2 activity in premature infants

Official Title
-----------------
Population Pharmacokinetics and Metabolomic Analysis of Aminopylline/Theophylline Drug Levels in Preterm Infants With Apnea of Prematurity

Conditions
-----------------
Apea of Prematurity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inborn preterm infants (GA < 37 weeks) Dx : Apnea of prematurity Tx : Aminophylline / Theophylline Informed consent of parents Exclusion Criteria: Major congenital anomaly Expired within 72 hours Proven secondary apnea

Ages Eligible for Study
-----------------
Maximum Age: 37 Weeks

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Theophylline
ATP/AMP Challenge in Healthy Non-smokers, Smokers, Patients With Asthma, and Patients With Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
=================
Brief Summary
-----------------
In this randomised, cross-over, controlled study, a total of 84 subjects will be included: 12 healthy non-smoking volunteers; 12 current smokers; 30 patients with mild steroid-naïve asthma; and 30 patients with mild-moderate COPD. Each subject will have 1 screening visit (if necessary) and 2 study visits. At visits 2 and 3 the effects of adenosine 5'-triphosphate (ATP) or adenosine 5'-monophosphate (AMP) challenge, given in a random order, will be tested.

Official Title
-----------------
Adenosine 5'-Triphosphate (ATP) Challenge in Healthy Non-smokers, Current Smokers and Patients With Mild Asthma and Chronic Obstructive Pulmonary Disease (COPD)

Conditions
-----------------
Asthma, COPD, Smoking

Intervention / Treatment
-----------------
* Procedure: Inhalation Challenge with ATP
* Procedure: Inhalation Challenge with AMP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy non-smokers (n=12) Normal spirometry Forced expiratory volume in 1 second (FEV1) reversibility of < 15% after inhaled beta2-agonists* At risk (current smokers) (n=12)* Normal spirometry, chronic symptoms (cough, sputum production) FEV1 reversibility of < 15% after inhaled beta2-agonists* (* = Global Strategy for the Diagnosis, Management, and Prevention of COPD) Mild steroid-naïve asthma (n=30) FEV1 more than or equal to 80% Mild-moderate COPD (n=30) FEV1 50-80% Exclusion Criteria: Pregnancy, breast-feeding, or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator Upper respiratory infection within the last 4 weeks Subjects who have received research medication within the previous one month Subjects unable to give informed consent Any psychiatric condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Inhalation Challenge with ATP|nan|
|Procedure: Inhalation Challenge with AMP|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PC20 of ATP and AMP |  |  | 
| Lung function |  |  | 
| Borg score |  |  | 
| Impulse oscillometry (IOS) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Volunteers (smokers), Healthy Volunteers (Non-smokers), Asthma Patients, COPD Patients